−CITE− 42 USC Sec. 300u−6 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XV − HEALTH INFORMATION AND HEALTH PROMOTION −HEAD− Sec. 300u−6. Office of Minority Health −STATUTE− (a) In general There is established an Office of Minority Health within the Office of Public Health and Science. There shall be in the Department of Health and Human Services a Deputy Assistant Secretary for Minority Health, who shall be the head of the Office of Minority Health. The Secretary, acting through such Deputy Assistant Secretary, shall carry out this section. (b) Duties With respect to improving the health of racial and ethnic minority groups, the Secretary, acting through the Deputy Assistant Secretary for Minority Health (in this section referred to as the "Deputy Assistant Secretary"), shall carry out the following: (1) Establish short−range and long−range goals and objectives and coordinate all other activities within the Public Health Service that relate to disease prevention, health promotion, service delivery, and research concerning such individuals. The

1

heads of each of the agencies of the Service shall consult with the Deputy Assistant Secretary to ensure the coordination of such activities. (2) Enter into interagency agreements with other agencies of the Public Health Service. (3) Support research, demonstrations and evaluations to test new and innovative models. (4) Increase knowledge and understanding of health risk factors. (5) Develop mechanisms that support better information dissemination, education, prevention, and service delivery to individuals from disadvantaged backgrounds, including individuals who are members of racial or ethnic minority groups. (6) Ensure that the National Center for Health Statistics collects data on the health status of each minority group. (7) With respect to individuals who lack proficiency in speaking the English language, enter into contracts with public and nonprofit private providers of primary health services for the purpose of increasing the access of the individuals to such services by developing and carrying out programs to provide bilingual or interpretive services. (8) Support a national minority health resource center to carry out the following: (A) Facilitate the exchange of information regarding matters relating to health information and health promotion, preventive health services, and education in the appropriate use of health

2

care. (B) Facilitate access to such information. (C) Assist in the analysis of issues and problems relating to such matters. (D) Provide technical assistance with respect to the exchange of such information (including facilitating the development of materials for such technical assistance). (9) Carry out programs to improve access to health care services for individuals with limited proficiency in speaking the English language. Activities under the preceding sentence shall include developing and evaluating model projects. (10) Advise in matters related to the development, implementation, and evaluation of health professions education in decreasing disparities in health care outcomes, including cultural competency as a method of eliminating health disparities. (c) Advisory Committee (1) In general The Secretary shall establish an advisory committee to be known as the Advisory Committee on Minority Health (in this subsection referred to as the "Committee"). (2) Duties The Committee shall provide advice to the Deputy Assistant Secretary carrying out this section, including advice on the development of goals and specific program activities under paragraphs (1) through (10) of subsection (b) of this section for

3

each racial and ethnic minority group. (3) Chair The chairperson of the Committee shall be selected by the Secretary from among the members of the voting members of the Committee. The term of office of the chairperson shall be 2 years. (4) Composition (A) The Committee shall be composed of 12 voting members appointed in accordance with subparagraph (B), and nonvoting, ex officio members designated in subparagraph (C). (B) The voting members of the Committee shall be appointed by the Secretary from among individuals who are not officers or employees of the Federal Government and who have expertise regarding issues of minority health. The racial and ethnic minority groups shall be equally represented among such members. (C) The nonvoting, ex officio members of the Committee shall be such officials of the Department of Health and Human Services as the Secretary determines to be appropriate. (5) Terms Each member of the Committee shall serve for a term of 4 years, except that the Secretary shall initially appoint a portion of the members to terms of 1 year, 2 years, and 3 years. (6) Vacancies If a vacancy occurs on the Committee, a new member shall be appointed by the Secretary within 90 days from the date that the vacancy occurs, and serve for the remainder of the term for which

4

the predecessor of such member was appointed. The vacancy shall not affect the power of the remaining members to execute the duties of the Committee. (7) Compensation Members of the Committee who are officers or employees of the United States shall serve without compensation. Members of the Committee who are not officers or employees of the United States shall receive compensation, for each day (including travel time) they are engaged in the performance of the functions of the Committee. Such compensation may not be in an amount in excess of the daily equivalent of the annual maximum rate of basic pay payable under the General Schedule (under title 5) for positions above GS−15. (d) Certain requirements regarding duties (1) Recommendations regarding language (A) Proficiency in speaking English The Deputy Assistant Secretary shall consult with the Director of the Office of International and Refugee Health, the Director of the Office of Civil Rights, and the Directors of other appropriate departmental entities regarding recommendations for carrying out activities under subsection (b)(9) of this section. (B) Health professions education regarding health disparities The Deputy Assistant Secretary shall carry out the duties under subsection (b)(10) of this section in collaboration with appropriate personnel of the Department of Health and Human

5

Services, other Federal agencies, and other offices, centers, and institutions, as appropriate, that have responsibilities under the Minority Health and Health Disparities Research and Education Act of 2000. (2) Equitable allocation regarding activities In carrying out subsection (b) of this section, the Secretary shall ensure that services provided under such subsection are equitably allocated among all groups served under this section by the Secretary. (3) Cultural competency of services The Secretary shall ensure that information and services provided pursuant to subsection (b) of this section are provided in the language, educational, and cultural context that is most appropriate for the individuals for whom the information and services are intended. (e) Grants and contracts regarding duties (1) In general In carrying out subsection (b) of this section, the Secretary acting through the Deputy Assistant Secretary may make awards of grants, cooperative agreements, and contracts to public and nonprofit private entities. (2) Process for making awards The Deputy Assistant Secretary shall ensure that awards under paragraph (1) are made, to the extent practical, only on a competitive basis, and that a grant is awarded for a proposal only if the proposal has been recommended for such an award

6

through a process of peer review. (3) Evaluation and dissemination The Deputy Assistant Secretary, directly or through contracts with public and private entities, shall provide for evaluations of projects carried out with awards made under paragraph (1) during the preceding 2 fiscal years. The report shall be included in the report required under subsection (f) of this section for the fiscal year involved. (f) Reports (1) In general Not later than February 1 of fiscal year 1999 and of each second year thereafter, the Secretary shall submit to the Committee on Energy and Commerce of the House of Representatives, and to the Committee on Labor and Human Resources of the Senate, a report describing the activities carried out under this section during the preceding 2 fiscal years and evaluating the extent to which such activities have been effective in improving the health of racial and ethnic minority groups. Each such report shall include the biennial reports submitted under subsections (e)(3) and (f)(2) (!1) of this section for such years by the heads of the Public Health Service agencies. (2) Agency reports Not later than February 1, 1999, and biennially thereafter, the heads of the Public Health Service agencies shall submit to the Deputy Assistant Secretary a report summarizing the minority health activities of each of the respective agencies.

7

(g) Definitions For purposes of this section: (1) The term "racial and ethnic minority group" means American Indians (including Alaska Natives, Eskimos, and Aleuts); Asian Americans; Native Hawaiians and other Pacific Islanders; Blacks; and Hispanics. (2) The term "Hispanic" means individuals whose origin is Mexican, Puerto Rican, Cuban, Central or South American, or any other Spanish−speaking country. (h) Funding (1) (!2) Authorization of appropriations. − For the purpose of carrying out this section, there are authorized to be appropriated $30,000,000 for fiscal year 1998, and such sums as may be necessary for each of the fiscal years 1999 through 2002. −SOURCE− (July 1, 1944, ch. 373, title XVII, Sec. 1707, as added Pub. L. 101−527, Sec. 2, Nov. 6, 1990, 104 Stat. 2312; amended Pub. L. 101−557, title IV, Sec. 401(a)(1), Nov. 15, 1990, 104 Stat. 2770; Pub. L. 105−392, title II, Sec. 201(a), (c), Nov. 13, 1998, 112 Stat. 3582, 3585; Pub. L. 106−525, title IV, Sec. 403, title VI, Sec. 601, Nov. 22, 2000, 114 Stat. 2509, 2511.) −REFTEXT− REFERENCES IN TEXT The General Schedule, referred to in subsec. (c)(7), is set out under section 5332 of Title 5, Government Organization and Employees.

8

The Minority Health and Health Disparities Research and Education Act of 2000, referred to in subsec. (d)(1)(B), is Pub. L. 106−525, Nov. 22, 2000, 114 Stat. 2495. For complete classification of this Act to the Code, see Short Title of 2000 Amendments note set out under section 201 of this title and Tables. Subsections (e)(3) and (f)(2) of this section, referred to in subsec. (f)(1), was in the original "sections 201(e)(3) and 201(f)(2)", and was translated to reflect the probable intent of Congress, because section 201 of act July 1, 1944, which is classified to section 202 of this title, does not contain subsections, and subsections (e)(3) and (f)(2) of this section require biennial reporting. −MISC1− PRIOR PROVISIONS A prior section 300u−6, act July 1, 1944, ch. 373, title XVII, Sec. 1707, as added Nov. 10, 1978, Pub. L. 95−626, title V, Sec. 502, 92 Stat. 3593; amended July 10, 1979, Pub. L. 96−32, Sec. 6(k), 93 Stat. 84, related to project grants to State Councils on Physical Fitness for physical fitness improvement, prior to repeal by Pub. L. 98−551, Sec. 2(c), Oct. 30, 1984, 98 Stat. 2816. AMENDMENTS 2000 − Subsec. (b)(10). Pub. L. 106−525, Sec. 403(1), added par. (10). Subsec. (c)(2). Pub. L. 106−525, Sec. 403(2), substituted "paragraphs (1) through (10)" for "paragraphs (1) through (9)". Subsec. (d)(1). Pub. L. 106−525, Sec. 403(3), amended heading and

9

text of par. (1) generally. Prior to amendment, text read as follows: "The Deputy Assistant Secretary for Minority Health shall consult with the Director of the Office of International and Refugee Health, the Director of the Office of Civil Rights, and the Directors of other appropriate departmental entities regarding recommendations for carrying out activities under subsection (b)(9) of this section." Subsec. (g)(1). Pub. L. 106−525, Sec. 601, substituted "Asian Americans;" for "Asian Americans and" and inserted "Native Hawaiians and other" before "Pacific Islanders;". 1998 − Pub. L. 105−392, Sec. 201(c)(1), struck out "Establishment of" before "Office" in section catchline. Subsec. (a). Pub. L. 105−392, Sec. 201(c)(2), substituted "Public Health and Science" for "the Assistant Secretary for Health". Subsecs. (b) to (h). Pub. L. 105−392, Sec. 201(a), added subsecs. (b) to (h) and struck out former subsecs. (b) to (f), which related, respectively, to duties of Secretary, certain requirements regarding duties, grants and contracts regarding duties, reports, and funding. 1990 − Subsec. (b)(8). Pub. L. 101−557 added par. (8). −CHANGE− CHANGE OF NAME Committee on Energy and Commerce of House of Representatives treated as referring to Committee on Commerce of House of Representatives by section 1(a) of Pub. L. 104−14, set out as a note preceding section 21 of Title 2, The Congress. Committee on

10

Commerce of House of Representatives changed to Committee on Energy and Commerce of House of Representatives, and jurisdiction over matters relating to securities and exchanges and insurance generally transferred to Committee on Financial Services of House of Representatives by House Resolution No. 5, One Hundred Seventh Congress, Jan. 3, 2001. −MISC2− EFFECTIVE DATE OF 1990 AMENDMENT Section 401(a)(2) of Pub. L. 101−557 provided that: "The amendments made by paragraph (1) [amending this section] shall take effect on the date of the enactment of the Disadvantaged Minority Health Improvement Act of 1990 [Nov. 6, 1990]." TERMINATION OF ADVISORY COMMITTEES Advisory committees established after Jan. 5, 1973, to terminate not later than the expiration of the 2−year period beginning on the date of their establishment, unless, in the case of a committee established by the President or an officer of the Federal Government, such committee is renewed by appropriate action prior to the expiration of such 2−year period, or in the case of a committee established by the Congress, its duration is otherwise provided by law. See section 14 of Pub. L. 92−463, Oct. 6, 1972, 86 Stat. 776, set out in the Appendix to Title 5, Government Organization and Employees. Pub. L. 93−641, Sec. 6, Jan. 4, 1975, 88 Stat. 2275, set out as a note under section 217a of this title, provided that an advisory committee established pursuant to the Public Health Service Act

11

shall terminate at such time as may be specifically prescribed by an Act of Congress enacted after Jan. 4, 1975. CONGRESSIONAL FINDINGS Section 1(b) of Pub. L. 101−527 provided that: "The Congress finds that − "(1) racial and ethnic minorities are disproportionately represented among individuals from disadvantaged backgrounds; "(2) the health status of individuals from disadvantaged backgrounds, including racial and ethnic minorities, in the United States is significantly lower than the health status of the general population of the United States; "(3) minorities suffer disproportionately high rates of cancer, stroke, heart diseases, diabetes, substance abuse, acquired immune deficiency syndrome, and other diseases and disorders; "(4) the incidence of infant mortality among minorities is almost double that for the general population; "(5) Blacks, Hispanics, and Native Americans constitute approximately 12 percent, 7.9 percent, and 0.01 percent, respectively, of the population of the United States; "(6) Blacks, Hispanics, and Native Americans in the United States constitute approximately 3 percent, 4 percent, and less than 0.01 percent, respectively, of physicians, 2.7 percent, 1.7 percent, and less than 0.01 percent, respectively, of dentists, and 4.5 percent, 1.6 percent, and less than 0.01 percent, respectively, of nurses; "(7) the number of individuals who are from disadvantaged

12

backgrounds in health professions should be increased for the purpose of improving the access of other such individuals to health services; "(8) minority health professionals have historically tended to practice in low−income areas and to serve minorities; "(9) minority health professionals have historically tended to engage in the general practice of medicine and specialties providing primary care; "(10) reports published in leading medical journals indicate that access to health care among minorities can be substantially improved by increasing the number of minority health professionals; "(11) increasing the number of minorities serving on the faculties of health professions schools can be an important factor in attracting minorities to pursue a career in the health professions; "(12) diversity in the faculty and student body of health professions schools enhances the quality of education for all students attending the schools; "(13) the Report of the Secretary's Task Force on Black and Minority Health (prepared for the Secretary of Health and Human Services and issued in 1985) described the health status problems of minorities, and made recommendations concerning measures that should be implemented by the Secretary with respect to improving the health status of minorities through programs for providing health information and education; and

13

"(14) the Office of Minority Health, created in 1985 by the Secretary of Health and Human Services, should be authorized pursuant to statute and should receive increased funding to support efforts to improve the health of individuals from disadvantaged backgrounds, including minorities, including the implementation of the recommendations made by the Secretary's Task Force on Black and Minority Health." −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in sections 287c−31, 299a−1 of this title. −FOOTNOTE− (!1) See References in Text note below. (!2) So in original. No par. (2) has been enacted. −End− −CITE− 42 USC Sec. 300u−7 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XV − HEALTH INFORMATION AND HEALTH PROMOTION −HEAD− Sec. 300u−7. Office of Adolescent Health −STATUTE− (a) In general There is established an Office of Adolescent Health within the

14

Office of the Assistant Secretary for Health, which office (!1) shall be headed by a director (!1) appointed by the Secretary. The Secretary shall carry out this section acting through the Director of such Office. (b) Duties With respect to adolescent health, the Secretary shall − (1) coordinate all activities within the Department of Health and Human Services that relate to disease prevention, health promotion, preventive health services, and health information and education with respect to the appropriate use of health care, including coordinating − (A) the design of programs, support for programs, and the evaluation of programs; (B) the monitoring of trends; (C) projects of research (including multidisciplinary projects) on adolescent health; and (D) the training of health providers who work with adolescents, particularly nurse practitioners, physician assistants, and social workers; (2) coordinate the activities described in paragraph (1) with similar activities in the private sector; and (3) support projects, conduct research, and disseminate information relating to preventive medicine, health promotion, and physical fitness and sports medicine. (c) Certain demonstration projects (1) In general

15

In carrying out subsection (b)(3) of this section, the Secretary may make grants to carry out demonstration projects for the purpose of improving adolescent health, including projects to train health care providers in providing services to adolescents and projects to reduce the incidence of violence among adolescents, particularly among minority males. (2) Authorization of appropriations For the purpose of carrying out paragraph (1), there are authorized to be appropriated $5,000,000 for fiscal year 1993, and such sums as may be necessary for each of the fiscal years 1994 through 1997. (d) Information clearinghouse In carrying out subsection (b) of this section, the Secretary shall establish and maintain a National Information Clearinghouse on Adolescent Health to collect and disseminate to health professionals and the general public information on adolescent health. (e) National plan In carrying out subsection (b) of this section, the Secretary shall develop a national plan for improving adolescent health. The plan shall be consistent with the applicable objectives established by the Secretary for the health status of the people of the United States for the year 2000, and shall be periodically reviewed, and as appropriate, revised. The plan, and any revisions in the plan, shall be submitted to the Committee on Energy and Commerce of the House of Representatives and the Committee on Labor and Human

16

Resources of the Senate. (f) Adolescent health For purposes of this section, the term "adolescent health", with respect to adolescents of all ethnic and racial groups, means all diseases, disorders, and conditions (including with respect to mental health) − (1) unique to adolescents, or more serious or more prevalent in adolescents; (2) for which the factors of medical risk or types of medical intervention are different for adolescents, or for which it is unknown whether such factors or types are different for adolescents; or (3) with respect to which there has been insufficient clinical research involving adolescents as subjects or insufficient clinical data on adolescents. −SOURCE− (July 1, 1944, ch. 373, title XVII, Sec. 1708, as added Pub. L. 102−531, title III, Sec. 302, Oct. 27, 1992, 106 Stat. 3483.) −MISC1− PRIOR PROVISIONS A prior section 300u−7, act July 1, 1944, ch. 373, title XVII, Sec. 1708, as added Nov. 10, 1978, Pub. L. 95−626, title V, Sec. 502, 92 Stat. 3594; amended July 10, 1979, Pub. L. 96−32, Sec. 6(l), 93 Stat. 84, related to project grants for physical fitness improvement and research projects, prior to repeal by Pub. L. 98−551, Sec. 2(c), Oct. 30, 1984, 98 Stat. 2816.

17

−CHANGE− CHANGE OF NAME Committee on Energy and Commerce of House of Representatives treated as referring to Committee on Commerce of House of Representatives by section 1(a) of Pub. L. 104−14, set out as a note preceding section 21 of Title 2, The Congress. Committee on Commerce of House of Representatives changed to Committee on Energy and Commerce of House of Representatives, and jurisdiction over matters relating to securities and exchanges and insurance generally transferred to Committee on Financial Services of House of Representatives by House Resolution No. 5, One Hundred Seventh Congress, Jan. 3, 2001. −FOOTNOTE− (!1) So in original. Probably should be capitalized. −End− −CITE− 42 USC Sec. 300u−8 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XV − HEALTH INFORMATION AND HEALTH PROMOTION −HEAD− Sec. 300u−8. Biennial report regarding nutrition and health −STATUTE− (a) Biennial report The Secretary shall require the Surgeon General of the Public

18

Health Service to prepare biennial reports on the relationship between nutrition and health. Such reports may, with respect to such relationship, include any recommendations of the Secretary and the Surgeon General. (b) Submission to Congress The Secretary shall ensure that, not later than February 1 of 1995 and of every second year thereafter, a report under subsection (a) of this section is submitted to the Committee on Energy and Commerce of the House of Representatives and the Committee on Labor and Human Resources of the Senate. −SOURCE− (July 1, 1944, ch. 373, title XVII, Sec. 1709, as added Pub. L. 103−183, title VII, Sec. 704, Dec. 14, 1993, 107 Stat. 2240.) −MISC1− PRIOR PROVISIONS A prior section 300u−8, act July 1, 1944, ch. 373, title XVII, Sec. 1709, as added Nov. 10, 1978, Pub. L. 95−626, title V, Sec. 502, 92 Stat. 3594, related to establishment of national program on sports medicine research, prior to repeal by Pub. L. 98−551, Sec. 2(c), Oct. 30, 1984, 98 Stat. 2816. −CHANGE− CHANGE OF NAME Committee on Energy and Commerce of House of Representatives treated as referring to Committee on Commerce of House of Representatives by section 1(a) of Pub. L. 104−14, set out as a note preceding section 21 of Title 2, The Congress. Committee on

19

Commerce of House of Representatives changed to Committee on Energy and Commerce of House of Representatives, and jurisdiction over matters relating to securities and exchanges and insurance generally transferred to Committee on Financial Services of House of Representatives by House Resolution No. 5, One Hundred Seventh Congress, Jan. 3, 2001. −End− −CITE− 42 USC Sec. 300u−9 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XV − HEALTH INFORMATION AND HEALTH PROMOTION −HEAD− Sec. 300u−9. Education regarding DES −STATUTE− (a) In general The Secretary, acting through the heads of the appropriate agencies of the Public Health Service, shall carry out a national program for the education of health professionals and the public with respect to the drug diethylstilbestrol (commonly known as DES). To the extent appropriate, such national program shall use methodologies developed through the education demonstration program carried out under section 283a of this title. In developing and carrying out the national program, the Secretary shall consult closely with representatives of nonprofit private entities that

20

represent individuals who have been exposed to DES and that have expertise in community−based information campaigns for the public and for health care providers. The implementation of the national program shall begin during fiscal year 1999. (b) Authorization of appropriations For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 1999 through 2003. The authorization of appropriations established in the preceding sentence is in addition to any other authorization of appropriation that is available for such purpose. −SOURCE− (July 1, 1944, ch. 373, title XVII, Sec. 1710, as added Pub. L. 105−340, title I, Sec. 101(b), Oct. 31, 1998, 112 Stat. 3191.) −MISC1− PRIOR PROVISIONS A prior section 300u−9, act July 1, 1944, ch. 373, title XVII, Sec. 1710, as added Nov. 10, 1978, Pub. L. 95−626, title V, Sec. 502, 92 Stat. 3594; amended Oct. 17, 1979, Pub. L. 96−88, title III, Sec. 301(b)(2), title V, Sec. 507, 93 Stat. 678, 692, related to Conference on Education in Lifetime Sports, prior to repeal by Pub. L. 98−551, Sec. 2(c), Oct. 30, 1984, 98 Stat. 2816. −End− −CITE− 42 USC SUBCHAPTER XVI − PRESIDENT'S COMMISSION FOR THE STUDY OF ETHICAL PROBLEMS IN MEDICINE AND

21

BIOMEDICAL AND BEHAVIOR RESEARCH 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XVI − PRESIDENT'S COMMISSION FOR THE STUDY OF ETHICAL PROBLEMS IN MEDICINE AND BIOMEDICAL AND BEHAVIOR RESEARCH −HEAD− SUBCHAPTER XVI − PRESIDENT'S COMMISSION FOR THE STUDY OF ETHICAL PROBLEMS IN MEDICINE AND BIOMEDICAL AND BEHAVIOR RESEARCH −End− −CITE− 42 USC Sec. 300v 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XVI − PRESIDENT'S COMMISSION FOR THE STUDY OF ETHICAL PROBLEMS IN MEDICINE AND BIOMEDICAL AND BEHAVIOR RESEARCH −HEAD− Sec. 300v. Commission −STATUTE− (a) Establishment; composition; appointment of members; vacancies (1) There is established the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research (hereinafter in this subchapter referred to as the

22

"Commission") which shall be composed of eleven members appointed by the President. The members of the Commission shall be appointed as follows: (A) Three of the members shall be appointed from individuals who are distinguished in biomedical or behavioral research. (B) Three of the members shall be appointed from individuals who are distinguished in the practice of medicine or otherwise distinguished in the provision of health care. (C) Five of the members shall be appointed from individuals who are distinguished in one or more of the fields of ethics, theology, law, the natural sciences (other than a biomedical or behavioral science), the social sciences, the humanities, health administration, government, and public affairs. (2) No individual who is a full−time officer or employee of the United States may be appointed as a member of the Commission. The Secretary of Health and Human Services, the Secretary of Defense, the Director of Central Intelligence, the Director of the Office of Science and Technology Policy, the Secretary of Veterans Affairs, and the Director of the National Science Foundation shall each designate an individual to provide liaison with the Commission. (3) No individual may be appointed to serve as a member of the Commission if the individual has served for two terms of four years each as such a member. (4) A vacancy in the Commission shall be filled in the manner in which the original appointment was made. (b) Terms of members

23

(1) Except as provided in paragraphs (2) and (3), members shall be appointed for terms of four years. (2) Of the members first appointed − (A) four shall be appointed for terms of three years, and (B) three shall be appointed for terms of two years, as designated by the President at the time of appointment. (3) Any member appointed to fill a vacancy occurring before the expiration of the term for which his predecessor was appointed shall be appointed only for the remainder of such term. A member may serve after the expiration of his term until his successor has taken office. (c) Chairman The Chairman of the Commission shall be appointed by the President, by and with the advice and consent of the Senate, from members of the Commission. (d) Meetings (1) Seven members of the Commission shall constitute a quorum for business, but a lesser number may conduct hearings. (2) The Commission shall meet at the call of the Chairman or at the call of a majority of its members. (e) Compensation; travel expenses, etc. (1) Members of the Commission shall each be entitled to receive the daily equivalent of the annual rate of basic pay in effect for grade GS−18 of the General Schedule for each day (including travel time) during which they are engaged in the actual performance of duties vested in the Commission.

24

(2) While away from their homes or regular places of business in the performance of services for the Commission, members of the Commission shall be allowed travel expenses, including per diem in lieu of subsistence, in the same manner as persons employed intermittently in the Government service are allowed expenses under section 5703 of title 5. −SOURCE− (July 1, 1944, ch. 373, title XVIII, Sec. 1801, as added Pub. L. 95−622, title III, Sec. 301, Nov. 9, 1978, 92 Stat. 3437; amended Pub. L. 96−88, title V, Sec. 509(b), Oct. 17, 1979, 93 Stat. 695; Pub. L. 100−527, Sec. 10(1), Oct. 25, 1988, 102 Stat. 2640.) −MISC1− AMENDMENTS 1988 − Subsec. (a)(2). Pub. L. 100−527 substituted "Secretary of Veterans Affairs" for "Administrator of Veterans' Affairs". −CHANGE− CHANGE OF NAME "Secretary of Health and Human Services" substituted for "Secretary of Health, Education, and Welfare" in subsec. (a)(2) pursuant to section 509(b) of Pub. L. 96−88, which is classified to section 3508(b) of Title 20, Education. −MISC2− EFFECTIVE DATE OF 1988 AMENDMENT Amendment by Pub. L. 100−527 effective Mar. 15, 1989, see section 18(a) of Pub. L. 100−527, set out as a Department of Veterans Affairs Act note under section 301 of Title 38, Veterans' Benefits.

25

REFERENCES IN OTHER LAWS TO GS−16, 17, OR 18 PAY RATES References in laws to the rates of pay for GS−16, 17, or 18, or to maximum rates of pay under the General Schedule, to be considered references to rates payable under specified sections of Title 5, Government Organization and Employees, see section 529 [title I, Sec. 101(c)(1)] of Pub. L. 101−509, set out in a note under section 5376 of Title 5. APPOINTMENT OF INITIAL MEMBERS Section 302(a) of Pub. L. 95−622 directed President to initially appoint members to President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research (established under the amendment made by section 301) [enacting this subchapter] not later than 90 days after Nov. 9, 1978. −EXEC− EXECUTIVE ORDER NO. 12184 Ex. Ord. No. 12184, Dec. 17, 1979, 44 F.R. 75091, which established the President's Special Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, was revoked by Ex. Ord. No. 12553, Feb. 25, 1986, 51 F.R. 7237. −End− −CITE− 42 USC Sec. 300v−1 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE

26

SUBCHAPTER XVI − PRESIDENT'S COMMISSION FOR THE STUDY OF ETHICAL PROBLEMS IN MEDICINE AND BIOMEDICAL AND BEHAVIOR RESEARCH −HEAD− Sec. 300v−1. Duties of Commission −STATUTE− (a) Studies and investigations; priority and order; report to President and Congress (1) The Commission shall undertake studies of the ethical and legal implications of − (A) the requirements for informed consent to participation in research projects and to otherwise undergo medical procedures; (B) the matter of defining death, including the advisability of developing a uniform definition of death; (C) voluntary testing, counseling, and information and education programs with respect to genetic diseases and conditions, taking into account the essential equality of all human beings, born and unborn; (D) the differences in the availability of health services as determined by the income or residence of the persons receiving the services; (E) current procedures and mechanisms designed (i) to safeguard the privacy of human subjects of behavioral and biomedical research, (ii) to ensure the confidentiality of individually identifiable patient records, and (iii) to ensure appropriate access of patients to information continued (!1) in such

27

records,(!2) and (F) such other matters relating to medicine or biomedical or behavioral research as the President may designate for study by the Commission. The Commission shall determine the priority and order of the studies required under this paragraph. (2) The Commission may undertake an investigation or study of any other appropriate matter which relates to medicine or biomedical or behavioral research (including the protection of human subjects of biomedical or behavioral research) and which is consistent with the purposes of this subchapter on its own initiative or at the request of the head of a Federal agency. (3) In order to avoid duplication of effort, the Commission may, in lieu of, or as part of, any study or investigation required or otherwise conducted under this subsection, use a study or investigation conducted by another entity if the Commission sets forth its reasons for such use. (4) Upon the completion of each investigation or study undertaken by the Commission under this subsection (including a study or investigation which merely uses another study or investigation), it shall report its findings (including any recommendations for legislation or administrative action) to the President and the Congress and to each Federal agency to which a recommendation in the report applies. (b) Recommendations to agencies; subsequent administrative requirements

28

(1) Within 60 days of the date a Federal agency receives a recommendation from the Commission that the agency take any action with respect to its rules, policies, guidelines, or regulations, the agency shall publish such recommendation in the Federal Register and shall provide opportunity for interested persons to submit written data, views, and arguments with respect to adoption of the recommendation. (2) Within the 180−day period beginning on the date of such publication, the agency shall determine whether the action proposed by such recommendation is appropriate, and, to the extent that it determines that − (A) such action is not appropriate, the agency shall, within such time period, provide the Commission with, and publish in the Federal Register, a notice of such determination (including an adequate statement of the reasons for the determination), or (B) such action is appropriate, the agency shall undertake such action as expeditiously as feasible and shall notify the Commission of the determination and the action undertaken. (c) Report on protection of human subjects; scope; submission to President, etc. The Commission shall biennially report to the President, the Congress, and appropriate Federal agencies on the protection of human subjects of biomedical and behavioral research. Each such report shall include a review of the adequacy and uniformity (1) of the rules, policies, guidelines, and regulations of all Federal agencies regarding the protection of human subjects of biomedical

29

or behavioral research which such agencies conduct or support, and (2) of the implementation of such rules, policies, guidelines, and regulations by such agencies, and may include such recommendations for legislation and administrative action as the Commission deems appropriate. (d) Annual report; scope; submission to President, etc. Not later than December 15 of each year (beginning with 1979) the Commission shall report to the President, the Congress, and appropriate Federal agencies on the activities of the Commission during the fiscal year ending in such year. Each such report shall include a complete list of all recommendations described in subsection (b)(1) of this section made to Federal agencies by the Commission during the fiscal year and the actions taken, pursant (!3) to subsection (b)(2) of this section, by the agencies upon such recommendations, and may include such recommendations for legislation and administrative action as the Commission deems appropriate. (e) Publication and dissemination of reports The Commission may at any time publish and disseminate to the public reports respecting its activities. (f) Definitions For purposes of this section: (1) The term "Federal agency" means an authority of the government of the United States, but does not include (A) the Congress, (B) the courts of the United States, and (C) the government of the Commonwealth of Puerto Rico, the government of

30

the District of Columbia, or the government of any territory or possession of the United States. (2) The term "protection of human subjects" includes the protection of the health, safety, and privacy of individuals. −SOURCE− (July 1, 1944, ch. 373, title XVIII, Sec. 1802, as added Pub. L. 95−622, title III, Sec. 301, Nov. 9, 1978, 92 Stat. 3439; amended Pub. L. 96−32, Sec. 4, July 10, 1979, 93 Stat. 82.) −MISC1− AMENDMENTS 1979 − Subsec. (f). Pub. L. 96−32 redesignated definitions subsection following subsec. (e) as (f), which in original was designated as "(b)". −FOOTNOTE− (!1) So in original. Probably should be "contained". (!2) So in original. The comma probably should be a semicolon. (!3) So in original. Probably should be "pursuant". −End− −CITE− 42 USC Sec. 300v−2 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XVI − PRESIDENT'S COMMISSION FOR THE STUDY OF ETHICAL PROBLEMS IN MEDICINE AND BIOMEDICAL AND BEHAVIOR RESEARCH

31

−HEAD− Sec. 300v−2. Administrative provisions −STATUTE− (a) Hearings The Commission may for the purpose of carrying out this subchapter hold such hearings, sit and act at such times and places, take such testimony, and receive such evidence, as the Commission may deem advisable. (b) Appointment and compensation of staff personnel; procurement and compensation of temporary and intermittent services; detail of personnel from other Federal agencies (1) The Commission may appoint and fix the pay of such staff personnel as it deems desirable. Such personnel shall be appointed subject to the provisions of title 5 governing appointments in the competitive service, and shall be paid in accordance with the provisions of chapter 51 and subchapter III of chapter 53 of such title relating to classification and General Schedule pay rates. (2) The Commission may procure temporary and intermittent services to the same extent as is authorized by section 3109(b) of title 5, but at rates for individuals not to exceed the daily equivalent of the annual rate of basic pay in effect for grade GS−18 of the General Schedule. (3) Upon request of the Commission, the head of any Federal agency is authorized to detail, on a reimbursable basis, any of the personnel of such agency to the Commission to assist it in carrying out its duties under this subchapter.

32

(c) Contracting authority The Commission, in performing its duties and functions under this subchapter, may enter into contracts with appropriate public or nonprofit private entities. The authority of the Commission to enter into such contracts is effective for any fiscal year only to such extent or in such amounts as are provided in advance in appropriation Acts. (d) Informational requirements and prohibitions (1) The Commission may secure directly from any Federal agency information necessary to enable it to carry out this subchapter. Upon request of the Chairman of the Commission, the head of such agency shall furnish such information to the Commission. (2) The Commission shall promptly arrange for such security clearances for its members and appropriate staff as are necessary to obtain access to classified information needed to carry out its duties under this subchapter. (3) The Commission shall not disclose any information reported to or otherwise obtained by the Commission which is exempt from disclosure under subsection (a) of section 552 of title 5 by reason of paragraphs (4) and (6) of subsection (b) of such section. (e) Support services from Administrator of General Services The Administrator of General Services shall provide to the Commission on a reimbursable basis such administrative support services as the Commission may request. −SOURCE− (July 1, 1944, ch. 373, title XVIII, Sec. 1803, as added Pub. L.

33

95−622, title III, Sec. 301, Nov. 9, 1978, 92 Stat. 3440.) −REFTEXT− REFERENCES IN TEXT The provisions of title 5 governing appointments in the competitive service, referred to in subsec. (b)(1), are classified to section 3301 et seq. of Title 5, Government Organization and Employees. −MISC1− REFERENCES IN OTHER LAWS TO GS−16, 17, OR 18 PAY RATES References in laws to the rates of pay for GS−16, 17, or 18, or to maximum rates of pay under the General Schedule, to be considered references to rates payable under specified sections of Title 5, Government Organization and Employees, see section 529 [title I, Sec. 101(c)(1)] of Pub. L. 101−509, set out in a note under section 5376 of Title 5. −End− −CITE− 42 USC Sec. 300v−3 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XVI − PRESIDENT'S COMMISSION FOR THE STUDY OF ETHICAL PROBLEMS IN MEDICINE AND BIOMEDICAL AND BEHAVIOR RESEARCH −HEAD− Sec. 300v−3. Authorization of appropriations; termination of

34

Commission −STATUTE− (a) To carry out this subchapter there are authorized to be appropriated $5,000,000 for the fiscal year ending September 30, 1979, $5,000,000 for the fiscal year ending September 30, 1980, $5,000,000 for the fiscal year ending September 30, 1981, and $5,000,000 for the fiscal year ending September 30, 1982. (b) The Commission shall be subject to the Federal Advisory Committee Act, except that, under section 14(a)(1)(B) of such Act, the Commission shall terminate on December 31, 1982. −SOURCE− (July 1, 1944, ch. 373, title XVIII, Sec. 1804, as added Pub. L. 95−622, title III, Sec. 301, Nov. 9, 1978, 92 Stat. 3441.) −REFTEXT− REFERENCES IN TEXT The Federal Advisory Committee Act, referred to in subsec. (b), is Pub. L. 92−463, Oct. 6, 1972, 86 Stat. 770, as amended, which is set out in the Appendix to Title 5, Government Organization and Employees. −End− −CITE− 42 USC SUBCHAPTER XVII − BLOCK GRANTS 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XVII − BLOCK GRANTS

35

−HEAD− SUBCHAPTER XVII − BLOCK GRANTS −SECREF− SUBCHAPTER REFERRED TO IN OTHER SECTIONS This subchapter is referred to in sections 247b−6, 256d, 3013 of this title; title 31 section 6703. −End− −CITE− 42 USC Part A − Preventive Health and Health Services Block Grants 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XVII − BLOCK GRANTS Part A − Preventive Health and Health Services Block Grants −HEAD− PART A − PREVENTIVE HEALTH AND HEALTH SERVICES BLOCK GRANTS −SECREF− PART REFERRED TO IN OTHER SECTIONS This part is referred to in section 9875 of this title; title 25 section 1680h. −End− −CITE− 42 USC Sec. 300w 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE

36

CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XVII − BLOCK GRANTS Part A − Preventive Health and Health Services Block Grants −HEAD− Sec. 300w. Authorization of appropriations −STATUTE− (a) For the purpose of allotments under section 300w−1 of this title, there are authorized to be appropriated $205,000,000 for fiscal year 1993, and such sums as may be necessary for each of the fiscal years 1994 through 1998. (b) Of the amount appropriated for any fiscal year under subsection (a) of this section, at least $7,000,000 shall be made available for allotments under section 300w−1(b) of this title. −SOURCE− (July 1, 1944, ch. 373, title XIX, Sec. 1901, as added Pub. L. 97−35, title IX, Sec. 901, Aug. 13, 1981, 95 Stat. 535; amended Pub. L. 98−555, Sec. 4, Oct. 30, 1984, 98 Stat. 2855; Pub. L. 100−607, title III, Sec. 301(a), Nov. 4, 1988, 102 Stat. 3111; Pub. L. 102−531, title I, Sec. 101, Oct. 27, 1992, 106 Stat. 3469; Pub. L. 103−183, title VII, Sec. 705(e), Dec. 14, 1993, 107 Stat. 2241.) −MISC1− AMENDMENTS 1993 − Subsec. (a). Pub. L. 103−183 substituted "through 1998" for "through 1997". 1992 − Subsec. (a). Pub. L. 102−531, Sec. 101(a), amended subsec. (a) generally. Prior to amendment, subsec. (a) read as follows:

37

"For the purpose of allotments under section 300w−1 of this title, there is authorized to be appropriated $95,000,000 for fiscal year 1982, $96,500,000 for fiscal year 1983, $98,500,000 for fiscal year 1984, $98,500,000 for the fiscal year ending September 30, 1985, $98,500,000 for the fiscal year ending September 30, 1986, $98,500,000 for the fiscal year ending September 30, 1987, $110,000,000 for fiscal year 1989, and such sums as may be necessary for each of the fiscal years 1990 and 1991." Subsec. (b). Pub. L. 102−531, Sec. 101(b), substituted "$7,000,000" for "$3,500,000". 1988 − Subsec. (a). Pub. L. 100−607 struck out "and" after "1986," and inserted ", $110,000,000 for fiscal year 1989, and such sums as may be necessary for each of the fiscal years 1990 and 1991" before period at end. 1984 − Subsec. (a). Pub. L. 98−555, Sec. 4(a), inserted provisions authorizing appropriations for fiscal years ending Sept. 30, 1985, 1986, and 1987. Subsec. (b). Pub. L. 98−555, Sec. 4(b), substituted "$3,500,000" for "$3,000,000". EFFECTIVE DATE Section 901 of Pub. L. 97−35 provided in part that this subchapter is effective Oct. 1, 1981. −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in section 300w−1 of this title. −End−

38

−CITE− 42 USC Sec. 300w−1 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XVII − BLOCK GRANTS Part A − Preventive Health and Health Services Block Grants −HEAD− Sec. 300w−1. Allotments −STATUTE− (a) Availability based upon prior year distributions (1) From the amounts appropriated under section 300w of this title for any fiscal year and available for allotment under this subsection, the Secretary shall allot to each State an amount which bears the same ratio to the available amounts for that fiscal year as the amounts provided by the Secretary under the provisions of law listed in paragraph (2) to the State and entities in the State for fiscal year 1981 bore to the total amount appropriated for such provisions of law for fiscal year 1981. (2) The provisions of law referred to in paragraph (1) are the following provisions of law as in effect on September 30, 1981: (A) The authority for grants under section 247b of this title for preventive health service programs for the control of rodents. (B) The authority for grants under section 247b of this title for establishing and maintaining community and school−based

39

fluoridation programs. (C) The authority for grants under section 247b of this title for preventive health service programs for hypertension. (D) Sections 247b−1 (!1) and 247b−2 of this title. (E) Section 246(d) (!1) of this title. (F) Section 255(a) (!1) of this title. (G) Sections 300d−1,(!1) 300d−2,(!1) and 300d−3 (!1) of this title. (b) Population From the amount required to be made available under section 300w(b) of this title for allotments under this subsection for any fiscal year, the Secretary shall make allotments to each State on the basis of the population of the State. (c) Distribution of appropriated funds not allotted To the extent that all the funds appropriated under section 300w of this title for a fiscal year and available for allotment in such fiscal year are not otherwise allotted to States because − (1) one or more States have not submitted an application or description of activities in accordance with section 300w−4 of this title for the fiscal year; (2) one or more States have notified the Secretary that they do not intend to use the full amount of their allotment; or (3) some State allotments are offset or repaid under section 300w−5(b)(3) of this title; such excess shall be allotted among each of the remaining States in proportion to the amount otherwise allotted to such States for the

40

fiscal year without regard to this subsection. (d) Distributions to Indian tribes (1) If the Secretary − (A) receives a request from the governing body of an Indian tribe or tribal organization within any State that funds under this part be provided directly by the Secretary to such tribe or organization, and (B) determines that the members of such tribe or tribal organization would be better served by means of grants made directly by the Secretary under this part, the Secretary shall reserve from amounts which would otherwise be allotted to such State under subsection (a) of this section for the fiscal year the amount determined under paragraph (2). (2) The Secretary shall reserve for the purpose of paragraph (1) from amounts that would otherwise be allotted to such State under subsection (a) of this section an amount equal to the amount which bears the same ratio to the State's allotment for the fiscal year involved as the total amount provided or allotted for fiscal year 1981 by the Secretary to such tribe or tribal organization under the provisions of law referred to in subsection (a) of this section bore to the total amount provided or allotted for such fiscal year by the Secretary to the State and entities (including Indian tribes and tribal organizations) in the State under such provisions of law. (3) The amount reserved by the Secretary on the basis of a determination under this subsection shall be granted to the Indian

41

tribe or tribal organization serving the individuals for whom such a determination has been made. (4) In order for an Indian tribe or tribal organization to be eligible for a grant for a fiscal year under this subsection, it shall submit to the Secretary a plan for such fiscal year which meets such criteria as the Secretary may prescribe. (5) The terms "Indian tribe" and "tribal organization" have the same meaning given such terms in section 450b(b) and (c) (!2) of title 25. (e) Report on equitable distribution of available funds The Secretary shall conduct a study for the purpose of devising a formula for the equitable distribution of funds available for allotment to the States under this section. In conducting the study, the Secretary shall take into account − (1) the financial resources of the various States, (2) the populations of the States, and (3) any other factor which the Secretary may consider appropriate. Before June 30, 1982, the Secretary shall submit a report to the Congress respecting the development of a formula and make such recommendations as the Secretary may deem appropriate in order to ensure the most equitable distribution of funds under allotments under this section. −SOURCE− (July 1, 1944, ch. 373, title XIX, Sec. 1902, as added Pub. L. 97−35, title IX, Sec. 901, Aug. 13, 1981, 95 Stat. 535.)

42

−REFTEXT− REFERENCES IN TEXT Section 247b−1 of this title, referred to in subsec. (a)(2)(D), was in the original a reference to section 401 of the Health Services and Centers Amendments of 1978, Pub. L. 95−626, which was repealed effective Oct. 1, 1981, by Pub. L. 97−35, title IX, Sec. 902(a), (h), Aug. 13, 1981, 95 Stat. 559, 561. Pub. L. 100−572, Sec. 3, Oct. 31, 1988, 102 Stat. 2887, enacted section 317A of act July 1, 1944, which is classified to section 247b−1 of this title. Section 247b−2 of this title, referred to in subsec. (a)(2)(D), was repealed effective Oct. 1, 1981, by Pub. L. 97−35, title IX, Sec. 902(a), (h), Aug. 13, 1981, 95 Stat. 559, 561. Section 246(d) of this title, referred to in subsec. (a)(2)(E), was repealed effective Oct. 1, 1981, by Pub. L. 97−35, title IX, Sec. 902(b), (h), Aug. 13, 1981, 95 Stat. 559, 561. Section 255 of this title, referred to in subsec. (a)(2)(F), was in the original a reference to section 339 of act July 1, 1944, which was repealed effective Oct. 1, 1981, by Pub. L. 97−35, title IX, Sec. 902(b), (h), Aug. 13, 1981, 95 Stat. 559, 561. Pub. L. 97−414, Sec. 6(a), Jan. 4, 1983, 96 Stat. 2057, added a new section 339 of act July 1, 1944, which is classified to section 255 of this title. Sections 300d−1, 300d−2, and 300d−3 of this title, referred to in subsec. (a)(2)(G), were in the original references to sections 1202, 1203, and 1204, respectively, of act July 1, 1944, which were repealed effective Oct. 1, 1981, by Pub. L. 97−35, title IX, Sec.

43

902(d)(1), (h), Aug. 13, 1981, 95 Stat. 560, 561. Pub. L. 101−590, Sec. 3, Nov. 16, 1990, 104 Stat. 2916−2918, enacted new sections 1202, 1203, and 1204 of act July 1, 1944, which were classified to sections 300d−1, 300d−2, and 300d−3, respectively, of this title. Pub. L. 103−183, title VI, Sec. 601(b), Dec. 14, 1983, 107 Stat. 2238, repealed section 1202 and renumbered sections 1203 and 1204 as 1202 and 1203, respectively. Section 450b of title 25, referred to in subsec. (d)(5), has been amended, and subsecs. (b) and (c) of section 450b no longer define the terms "Indian tribe" and "tribal organization". However, such terms are defined elsewhere in that section. −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in sections 300w, 300w−2, 300w−3, 300w−4, 300w−7 of this title. −FOOTNOTE− (!1) See References in Text note below. (!2) See References in Text note below. −End− −CITE− 42 USC Sec. 300w−2 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XVII − BLOCK GRANTS Part A − Preventive Health and Health Services Block Grants

44

−HEAD− Sec. 300w−2. Payments under allotments to States −STATUTE− (a)(1) For each fiscal year, the Secretary shall make payments, as provided by section 6503(a) of title 31, to each State from its allotment under section 300w−1 of this title (other than any amount reserved under section 300w−1(d) of this title) from amounts appropriated for that fiscal year. (2) Any amount paid to a State for a fiscal year and remaining unobligated at the end of such year shall remain available for the next fiscal year to such State for the purposes for which it was made. (b) The Secretary, at the request of a State, may reduce the amount of payments under subsection (a) of this section by − (1) the fair market value of any supplies or equipment furnished the State, and (2) the amount of the pay, allowances, and travel expenses of any officer or employee of the Government when detailed to the State and the amount of any other costs incurred in connection with the detail of such officer or employee, when the furnishing of supplies or equipment or the detail of an officer or employee is for the convenience of and at the request of the State and for the purpose of conducting activities described in section 300w−3 of this title. The amount by which any payment is so reduced shall be available for payment by the Secretary of the costs incurred in furnishing the supplies or equipment or in

45

detailing the personnel, on which the reduction of the payment is based, and the amount shall be deemed to be part of the payment and shall be deemed to have been paid to the State. −SOURCE− (July 1, 1944, ch. 373, title XIX, Sec. 1903, as added Pub. L. 97−35, title IX, Sec. 901, Aug. 13, 1981, 95 Stat. 537.) −COD− CODIFICATION In subsec. (a)(1), "section 6503(a) of title 31" substituted for "section 203 of the Intergovernmental Cooperation Act of 1968 (42 U.S.C. 4213)" on authority of Pub. L. 97−258, Sec. 4(b), Sept. 13, 1982, 96 Stat. 1067, the first section of which enacted Title 31, Money and Finance. −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in sections 300w−3, 300w−4, 300w−5, 9875 of this title. −End− −CITE− 42 USC Sec. 300w−3 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XVII − BLOCK GRANTS Part A − Preventive Health and Health Services Block Grants −HEAD−

46

Sec. 300w−3. Use of allotments −STATUTE− (a) Preventive health services, comprehensive public health services, emergency medical services, etc. (1) Except as provided in subsections (b) and (c) of this section, payments made to a State under section 300w−2 of this title may be used for the following: (A) Activities consistent with making progress toward achieving the objectives established by the Secretary for the health status of the population of the United States for the year 2000 (in this part referred to as "year 2000 health objectives"). (B) Preventive health service programs for the control of rodents and for community and school−based fluoridation programs. (C) Feasibility studies and planning for emergency medical services systems and the establishment, expansion, and improvement of such systems. Amounts for such systems may not be used for the costs of the operation of the systems or the purchase of equipment for the systems, except that such amounts may be used for the payment of not more than 50 percent of the costs of purchasing communications equipment for the systems. Amounts may be expended for feasibility studies or planning for the trauma−care components of such systems only if the studies or planning, respectively, is consistent with the requirements of section 300d−13(a) of this title. (D) Providing services to victims of sex offenses and for prevention of sex offenses.

47

(E) The establishment, operation, and coordination of effective and cost−efficient systems to reduce the prevalence of illness due to asthma and asthma−related illnesses, especially among children, by reducing the level of exposure to cockroach allergen or other known asthma triggers through the use of integrated pest management, as applied to cockroaches or other known allergens. Amounts expended for such systems may include the costs of building maintenance and the costs of programs to promote community participation in the carrying out at such sites of integrated pest management, as applied to cockroaches or other known allergens. For purposes of this subparagraph, the term "integrated pest management" means an approach to the management of pests in public facilities that combines biological, cultural, physical, and chemical tools in a way that minimizes economic, health, and environmental risks. (F) With respect to activities described in any of subparagraphs (A) through (E), related planning, administration, and educational activities. (G) Monitoring and evaluation of activities carried out under any of subparagraphs (A) through (F). (2) Except as provided in subsection (b) of this section, amounts paid to a State under section 300w−2 of this title from its allotment under section 300w−1(b) of this title may only be used for providing services to rape victims and for rape prevention. (3) The Secretary may provide technical assistance to States in planning and operating activities to be carried out under this

48

part. (b) Prohibited uses A State may not use amounts paid to it under section 300w−2 of this title to − (1) provide inpatient services, (2) make cash payments to intended recipients of health services, (3) purchase or improve land, purchase, construct, or permanently improve (other than minor remodeling) any building or other facility, or purchase major medical equipment, (4) satisfy any requirement for the expenditure of non−Federal funds as a condition for the receipt of Federal funds, or (5) provide financial assistance to any entity other than a public or nonprofit private entity. Except as provided in subsection (a)(1)(E) of this section, the Secretary may waive the limitation contained in paragraph (3) upon the request of a State if the Secretary finds that there are extraordinary circumstances to justify the waiver and that granting the waiver will assist in carrying out this part. (c) Transfer of funds A State may transfer not more than 7 percent of the amount allotted to the State under section 300w−1(a) of this title for any fiscal year for use by the State under part B of this subchapter and title V of the Social Security Act [42 U.S.C. 701 et seq.] in such fiscal year as follows: At any time in the first three quarters of the fiscal year a State may transfer not more than 3

49

percent of the allotment of the State for the fiscal year for such use, and in the last quarter of a fiscal year a State may transfer for such use not more than the remainder of the amount of its allotment which may be transferred. (d) Limitation on administrative costs Of the amount paid to any State under section 300w−2 of this title, not more than 10 percent paid from each of its allotments under subsections (a) and (b) of section 300w−1 of this title may be used for administering the funds made available under section 300w−2 of this title. The State will pay from non−Federal sources the remaining costs of administering such funds. −SOURCE− (July 1, 1944, ch. 373, title XIX, Sec. 1904, as added Pub. L. 97−35, title IX, Sec. 901, Aug. 13, 1981, 95 Stat. 537; amended Pub. L. 97−414, Sec. 8(s), Jan. 4, 1983, 96 Stat. 2062; Pub. L. 99−646, Sec. 87(d)(1)(A), Nov. 10, 1986, 100 Stat. 3623; Pub. L. 99−654, Sec. 3(b)(1)(A), Nov. 14, 1986, 100 Stat. 3663; Pub. L. 100−607, title III, Sec. 301(b), Nov. 4, 1988, 102 Stat. 3111; Pub. L. 102−531, title I, Sec. 102, Oct. 27, 1992, 106 Stat. 3470; Pub. L. 106−310, div. A, title V, Sec. 511, Oct. 17, 2000, 114 Stat. 1116.) −REFTEXT− REFERENCES IN TEXT The Social Security Act, referred to in subsec. (c), is act Aug. 14, 1935, ch. 531, 49 Stat. 620, as amended. Title V of the Social Security Act is classified generally to subchapter V (Sec. 701 et

50

seq.) of chapter 7 of this title. For complete classification of this Act to the Code, see section 1305 of this title and Tables. −MISC1− AMENDMENTS 2000 − Subsec. (a)(1)(E). Pub. L. 106−310, Sec. 511(3), added subpar. (E). Former subpar. (E) redesignated (F). Subsec. (a)(1)(F). Pub. L. 106−310, Sec. 511(1), (4), redesignated subpar. (E) as (F) and substituted "subparagraphs (A) through (E)" for "subparagraphs (A) through (D)". Former subpar. (F) redesignated (G). Subsec. (a)(1)(G). Pub. L. 106−310, Sec. 511(1), (2), (5), redesignated subpar. (F) as (G) and substituted "subparagraphs (A) through (F)." for "subparagraphs (A) through (E)". 1992 − Subsec. (a)(1). Pub. L. 102−531, Sec. 102(a), amended par. (1) generally, substituting present provisions for provisions authorizing, except as provided in subsecs. (b) and (c), use of the amounts paid to a State under section 300w−2 of this title from its allotment under section 300w−1(a) of this title and amounts transferred by the State, for use in preventive health service programs, including hypertension and high cholesterol services, health−risk reduction programs, immunization services, home health agencies, emergency medical services, services to victims of sex offenses, and uterine cancer and breast cancer services. Subsec. (c). Pub. L. 102−531, Sec. 102(b), substituted "part B" for "parts B and C". 1988 − Subsec. (a)(1)(B). Pub. L. 100−607, Sec. 301(b)(1),

51

inserted "and elevated serum cholesterol" before period at end. Subsec. (a)(1)(C). Pub. L. 100−607, Sec. 301(b)(2), inserted ", including programs designed to reduce the incidence of chronic diseases" before period at end. Subsec. (a)(1)(D). Pub. L. 100−607, Sec. 301(b)(3), inserted ", including immunization services" before period at end. Subsec. (a)(1)(F). Pub. L. 100−607, Sec. 301(b)(4), substituted "systems, except that such amounts may be used for the payment of not more than 50 percent of the costs of purchasing communications equipment for the systems" for "systems (other than systems with respect to which grants were made as prescribed by section 300w−4(c)(2) of this title)". Subsec. (a)(1)(H). Pub. L. 100−607, Sec. 301(b)(5), added subpar. (H). 1986 − Subsec. (a)(1)(G). Pub. L. 99−646 and Pub. L. 99−654 amended subpar. (G) identically, substituting "victims of sex offenses and for prevention of sex offenses" for "rape victims and for rape prevention". 1983 − Subsec. (a)(1)(F). Pub. L. 97−414 inserted "(other than systems with respect to which grants were made as prescribed by section 300w−4(c)(2) of this title)" after "equipment for the systems". EFFECTIVE DATE OF 1986 AMENDMENTS Amendments by Pub. L. 99−646 and Pub. L. 99−654 effective 30 days after Nov. 10, 1986, and 30 days after Nov. 14, 1986, respectively, see section 87(e) of Pub. L. 99−646 and section 4 of Pub. L.

52

99−654, set out as an Effective Date note under section 2241 of Title 18, Crimes and Criminal Procedure. −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in sections 300w−2, 300w−4, 300w−5, 300w−9 of this title. −End− −CITE− 42 USC Sec. 300w−4 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XVII − BLOCK GRANTS Part A − Preventive Health and Health Services Block Grants −HEAD− Sec. 300w−4. Application for payments; State plan −STATUTE− (a) In general The Secretary may make payments under section 300w−2 of this title to a State for a fiscal year only if − (1) the State submits to the Secretary an application for the payments; (2) the application contains a State plan in accordance with subsection (b) of this section; (3) the application contains the certification described in subsection (c) of this section;

53

(4) the application contains such assurances as the Secretary may require regarding the compliance of the State with the requirements of this part (including assurances regarding compliance with the agreements described in subsection (c) of this section); and (5) the application is in such form and is submitted by such date as the Secretary may require. (b) State plan A State plan required in subsection (a)(2) of this section for a fiscal year is in accordance with this subsection if the plan meets the following conditions: (1) The plan is developed by the State agency with principal responsibility for public health programs, in consultation with the advisory committee established pursuant to subsection (c)(2) of this section. (2) The plan specifies the activities authorized in section 300w−3 of this title that are to be carried out with payments made to the State under section 300w−2 of this title, including a specification of the year 2000 health objectives for which the State will expend the payments. (3) The plan specifies the populations in the State for which such activities are to be carried out. (4) The plan specifies any populations in the State that have a disparate need for such activities. (5) With respect to each population specified under paragraph (3), the plan contains a strategy for expending such payments to

54

carry out such activities to make progress toward improving the health status of the population, which strategy includes − (A) a description of the programs and projects to be carried out; (B) an estimate of the number of individuals to be served by the programs and projects; and (C) an estimate of the number of public health personnel needed to carry out the strategy. (6) The plan specifies the amount of such payments to be expended for each of such activities and, with respect to the activity involved − (A) the amount to be expended for each population specified under paragraph (3); and (B) the amount to be expended for each population specified under paragraph (4). (c) State certification The certification referred to in subsection (a)(3) of this section for a fiscal year is a certification to the Secretary by the chief executive officer of the State involved as follows: (1)(A) In the development of the State plan required in subsection (a)(2) of this section − (i) the chief health officer of the State held public hearings on the plan; and (ii) proposals for the plan were made public in a manner that facilitated comments from public and private entities (including Federal and other public agencies).

55

(B) The State agrees that, if any revisions are made in such plan during the fiscal year, the State will, with respect to the revisions, hold hearings and make proposals public in accordance with subparagraph (A), and will submit to the Secretary a description of the revisions. (2) The State has established an advisory committee in accordance with subsection (d) of this section. (3) The State agrees to expend payments under section 300w−2 of this title only for the activities authorized in section 300w−3 of this title. (4) The State agrees to expend such payments in accordance with the State plan submitted under subsection (a)(2) of this section (with any revisions submitted to the Secretary under paragraph (1)(B)), including making expenditures to carry out the strategy contained in the plan pursuant to subsection (b)(5) of this section. (5)(A) The State agrees that, in the case of each population for which such strategy is carried out, the State will measure the extent of progress being made toward improving the health status of the population. (B) The State agrees that − (i) the State will collect and report data in accordance with section 300w−5(a) of this title; and (ii) for purposes of subparagraph (A), progress will be measured through use of each of the applicable uniform data items developed by the Secretary under paragraph (2) of such

56

section, or if no such items are applicable, through use of the uniform criteria developed by the Secretary under paragraph (3) of such section. (6) With respect to the activities authorized in section 300w−3 of this title, the State agrees to maintain State expenditures for such activities at a level that is not less than the average level of such expenditures maintained by the State for the 2−year period preceding the fiscal year for which the State is applying to receive payments under section 300w−2 of this title. (7) The State agrees to establish reasonable criteria to evaluate the effective performance of entities that receive funds from such payments and procedures for procedural and substantive independent State review of the failure by the State to provide funds for any such entity. (8) The State agrees to permit and cooperate with Federal investigations undertaken in accordance with section 300w−6 of this title. (9) The State has in effect a system to protect from inappropriate disclosure patient and sex offense victim records maintained by the State in connection with an activity funded under this part or by any entity which is receiving payments from the allotment of the State under this part. (10) The State agrees to provide the officer of the State government responsible for the administration of the State highway safety program with an opportunity to − (A) participate in the development of any plan by the State

57

relating to emergency medical services, as such plan relates to highway safety; and (B) review and comment on any proposal by any State agency to use any Federal grant or Federal payment received by the State for the provision of emergency medical services as such proposal relates to highway safety. (d) State Advisory Committee (1) In general For purposes of subsection (c)(2) of this section, an advisory committee is in accordance with this subsection if such committee is known as the State Preventive Health Advisory Committee (in this subsection referred to as the "Committee") and the Committee meets the conditions described in the subsequent paragraphs of this subsection. (2) Duties A condition under paragraph (1) for a State is that the duties of the Committee are − (A) to hold public hearings on the State plan required in subsection (a)(2) of this section; and (B) to make recommendations pursuant to subsection (b)(1) of this section regarding the development and implementation of such plan, including recommendations on − (i) the conduct of assessments of the public health; (ii) which of the activities authorized in section 300w−3 of this title should be carried out in the State; (iii) the allocation of payments made to the State under

58

section 300w−2 of this title; (iv) the coordination of activities carried out under such plan with relevant programs of other entities; and (v) the collection and reporting of data in accordance with section 300w−5(a) of this title. (3) Composition (A) A condition under paragraph (1) for a State is that the Committee is composed of such members of the general public, and such officials of the health departments of political subdivisions of the State, as may be necessary to provide adequate representation of the general public and of such health departments. (B) With respect to compliance with subparagraph (A), the membership of advisory committees established pursuant to subsection (c)(2) of this section may include representatives of community−based organizations (including minority community−based organizations), schools of public health, and entities to which the State involved awards grants or contracts to carry out activities authorized in section 300w−3 of this title. (4) Chair; meetings A condition under paragraph (1) for a State is that the State public health officer serves as the chair of the Committee, and that the Committee meets not less than twice each fiscal year. −SOURCE− (July 1, 1944, ch. 373, title XIX, Sec. 1905, as added Pub. L. 97−35, title IX, Sec. 901, Aug. 13, 1981, 95 Stat. 538; amended

59

Pub. L. 98−555, Sec. 5(a), (d), Oct. 30, 1984, 98 Stat. 2855, 2856; Pub. L. 99−646, Sec. 87(d)(1)(B), Nov. 10, 1986, 100 Stat. 3624; Pub. L. 99−654, Sec. 3(b)(1)(B), Nov. 14, 1986, 100 Stat. 3663; Pub. L. 100−607, title III, Sec. 301(c), Nov. 4, 1988, 102 Stat. 3112; Pub. L. 101−590, Sec. 4, Nov. 16, 1990, 104 Stat. 2928; Pub. L. 102−531, title I, Sec. 103(a), Oct. 27, 1992, 106 Stat. 3470.) −MISC1− AMENDMENTS 1992 − Pub. L. 102−531 amended section generally, substituting present provisions for provisions relating to submission and form of application for assistance under this part as well as required assurances, public hearings on proposed use and distribution of funds, certifications by chief executive officer of State, and a description of intended use of funds as well as public access to and revision of such description. 1990 − Subsec. (c). Pub. L. 101−590, which directed amendment of subsec. (c) by adding at the end thereof a new par. (7), was executed by adding par. (7) after par. (6) and before the last sentence to reflect the probable intent of Congress. 1988 − Subsec. (d). Pub. L. 100−607 inserted at end "The description shall include a statement of the public health objectives expected to be achieved by the State through the use of the payments the State will receive under section 300w−2 of this title." 1986 − Subsec. (c)(6). Pub. L. 99−646 and Pub. L. 99−654 amended par. (6) identically, substituting "sex offense" for "rape".

60

1984 − Subsec. (c)(2). Pub. L. 98−555, Sec. 5(a), redesignated par. (3) as (2). Former par. (2), which related to grants for fiscal year 1982, was struck out. Subsec. (c)(3). Pub. L. 98−555, Sec. 5(a), redesignated par. (5) as (3). Former par. (3) redesignated (2). Subsec. (c)(4). Pub. L. 98−555, Sec. 5(a), redesignated par. (6) as (4). Former par. (4), which related to grants for preventive health service programs for hypertension, was struck out. Subsec. (c)(5) to (8). Pub. L. 98−555, Sec. 5(a), redesignated pars. (7) and (8) as (5) and (6), respectively. Former pars. (5) and (6) redesignated (3) and (4), respectively. Subsec. (e). Pub. L. 98−555, Sec. 5(d), struck out subsec. (e) which related to grants by States. EFFECTIVE DATE OF 1986 AMENDMENTS Amendments by Pub. L. 99−646 and Pub. L. 99−654 effective 30 days after Nov. 10, 1986, and 30 days after Nov. 14, 1986, respectively, see section 87(e) of Pub. L. 99−646 and section 4 of Pub. L. 99−654, set out as an Effective Date note under section 2241 of Title 18, Crimes and Criminal Procedure. DELAYED APPLICABILITY OF REQUIREMENT REGARDING ADVISORY COMMITTEES Section 103(b) of Pub. L. 102−531 provided that: "With respect to compliance with the requirement established in subsection (c)(2) of section 1905 of the Public Health Service Act [subsec. (c)(2) of this section] (as amended by subsection (a) of this section), a State is deemed, notwithstanding such section, to be in compliance with such requirement if the State establishes an advisory

61

committee in accordance with subsection (d) of such section not later than 180 days after the date of the enactment of this Act [Oct. 27, 1992]." −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in sections 300w−1, 300w−5, 300w−6 of this title. −End− −CITE− 42 USC Sec. 300w−5 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XVII − BLOCK GRANTS Part A − Preventive Health and Health Services Block Grants −HEAD− Sec. 300w−5. Reports, data, and audits −STATUTE− (a) Annual reports; contents; data collection; copies (1) For purposes of section 300w−4(c)(5)(B)(i) of this title, a State is collecting and reporting data for a fiscal year in accordance with this subsection if the State submits to the Secretary, not later than February 1 of the succeeding fiscal year, a report that − (A) describes the purposes for which the State expended payments made to the State under section 300w−2 of this title;

62

(B) pursuant to section 300w−4(c)(5)(A) of this title, describes the extent of progress made by the State for purposes of such section; (C) meets the conditions described in the subsequent paragraphs of this subsection; and (D) contains such additional information regarding activities authorized in section 300w−3 of this title, and is submitted in such form, as the Secretary may require. (2)(A) The Secretary, in consultation with the States, shall develop sets of data for uniformly defining health status for purposes of the year 2000 health objectives (which sets are in this subsection referred to as "uniform data sets"). Each of such sets shall consist of one or more categories of information (in this subsection individually referred to as a "uniform data item"). The Secretary shall develop formats for the uniform collecting and reporting of information on such items. (B) A condition under paragraph (1)(C) for a fiscal year is that the State involved will, in accordance with the applicable format under subparagraph (A), collect during such year, and include in the report under paragraph (1), the necessary information for one uniform data item from each of the uniform data sets, which items are selected for the State by the Secretary. (C) In the case of fiscal year 1995 and each subsequent fiscal year, a condition under paragraph (1) for a State is that the State will, in accordance with the applicable format under subparagraph (A), collect during such year, and include in the report under

63

paragraph (1), the necessary information for each of the uniform data sets appropriate to the year 2000 health objectives that the State has, in the State plan submitted under section 300w−4 of this title for the fiscal year, specified as a purpose for which payments under section 300w−2 of this title are to be expended. (3) The Secretary, in consultation with the States, shall establish criteria for the uniform collection and reporting of data on activities authorized in section 300w−3 of this title with respect to which no uniform data items exist. (4) A condition under paragraph (1) for a fiscal year is that the State involved will make copies of the report submitted under such paragraph for the fiscal year available for public inspection, and will upon request provide a copy of the report to any individual for a charge not exceeding the cost of providing the copy. (b) Fiscal control; accounting procedures; annual audits; repayments and offsets; public inspection; Comptroller General evaluations; report to Congress (1) Each State shall establish fiscal control and fund accounting procedures as may be necessary to assure the proper disbursal of and accounting for Federal funds paid to the State under section 300w−2 of this title and funds transferred under section 300w−3(c) of this title for use under this part. (2) Each State shall annually audit its expenditures from payments received under section 300w−2 of this title. Such State audits shall be conducted by an entity independent of any agency administering a program funded under this part and, in so far as

64

practical, in accordance with the Comptroller General's standards for auditing governmental organizations, programs, activities, and functions. Within 30 days following the date each audit is completed, the chief executive officer of the State shall transmit a copy of that audit to the Secretary. (3) Each State shall, after being provided by the Secretary with adequate notice and opportunity for a hearing within the State, repay to the United States amounts found not to have been expended in accordance with the requirements of this part or the certification provided by the State under section 300w−4 of this title. If such repayment is not made, the Secretary shall, after providing the State with adequate notice and opportunity for a hearing within the State, offset such amounts against the amount of any allotment to which the State is or may become entitled under this part. (4) The State shall make copies of the reports and audits required by this section available for public inspection within the State. (5) The Comptroller General of the United States shall, from time to time, evaluate the expenditures by States of grants under this part in order to assure that expenditures are consistent with the provisions of this part and the certification provided by the State under section 300w−4 of this title. (6) Not later than October 1, 1990, the Secretary shall report to the Congress on the activities of the States that have received funds under this part and may include in the report any

65

recommendations for appropriate changes in legislation. (c) Inapplicability of title XVII of Omnibus Budget Reconciliation Act of 1981 Title XVII of the Omnibus Budget Reconciliation Act of 1981 shall not apply with respect to audits of funds allotted under this part. −SOURCE− (July 1, 1944, ch. 373, title XIX, Sec. 1906, as added Pub. L. 97−35, title IX, Sec. 901, Aug. 13, 1981, 95 Stat. 540; amended Pub. L. 98−555, Sec. 5(b), (c), Oct. 30, 1984, 98 Stat. 2855, 2856; Pub. L. 100−607, title III, Sec. 301(d), Nov. 4, 1988, 102 Stat. 3112; Pub. L. 102−531, title I, Sec. 104, Oct. 27, 1992, 106 Stat. 3473.) −REFTEXT− REFERENCES IN TEXT The Omnibus Budget Reconciliation Act of 1981, referred to in subsec. (c), is Pub. L. 97−35, Aug. 13, 1981, 95 Stat. 357, as amended. Title XVII of the Omnibus Budget Reconciliation Act of 1981 enacted sections 3595, and 4511 to 4514 of Title 5, Government Organization and Employees, amended sections 3393, 3593, 3596, 4501, 4502, 4505, 4506, 7542, 7543, 8340, and 8345 of Title 5, and sections 2003 and 2401 of Title 39, Postal Service, and enacted provisions set out as notes under sections 3595, 4501, 5303, 5343, 8340, and 8345 of Title 5, section 1243 of former Title 31, Money and Finance, and sections 403, 2003, 2004, and 2401 of Title 39. For complete classification of this Act to the Code, see Tables. −MISC1−

66

AMENDMENTS 1992 − Pub. L. 102−531, Sec. 104(b)(1), substituted "Reports, data, and audits" for "Reports and audits" in section catchline. Subsec. (a). Pub. L. 102−531, Sec. 104(a), amended subsec. (a) generally, substituting present provisions for provisions requiring an annual report by each State of its activities under this part, outlining the contents of such report, and for providing copies of the report to interested persons. Subsec. (d). Pub. L. 102−531, Sec. 104(b)(2), struck out subsec. (d) which provided for development of model criteria and forms for collection of data and information on services provided under this part. 1988 − Subsec. (a)(3). Pub. L. 100−607, Sec. 301(d)(1), added par. (3). Subsec. (b)(6). Pub. L. 100−607, Sec. 301(d)(2), substituted "1990" for "1983". 1984 − Subsec. (a)(1)(B). Pub. L. 98−555, Sec. 5(b), substituted "preventive health and preventive health services programs in the State assisted by funds from allotments under this part, including a summary of the services which were provided, the providers of such services, and the individuals who received such services" for "activities of the State under this part". Subsec. (d). Pub. L. 98−555, Sec. 5(c), added subsec. (d). −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in sections 300w−1, 300w−4, 9875 of

67

this title. −End− −CITE− 42 USC Sec. 300w−6 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XVII − BLOCK GRANTS Part A − Preventive Health and Health Services Block Grants −HEAD− Sec. 300w−6. Withholding of funds −STATUTE− (a) Prerequisites (1) The Secretary shall, after adequate notice and an opportunity for a hearing conducted within the affected State, withhold funds from any State which does not use its allotment in accordance with the requirements of this part or the certification provided under section 300w−4 of this title. The Secretary shall withhold such funds until the Secretary finds that the reason for the withholding has been removed and there is reasonable assurance that it will not recur. (2) The Secretary may not institute proceedings to withhold funds under paragraph (1) unless the Secretary has conducted an investigation concerning whether the State has used its allotment in accordance with the requirements of this part or the certification provided under section 300w−4 of this title.

68

Investigations required by this paragraph shall be conducted within the affected State by qualified investigators. (3) The Secretary shall respond in an expeditious manner to complaints of a substantial or serious nature that a State has failed to use funds in accordance with the requirements of this part or certifications provided under section 300w−4 of this title. (4) The Secretary may not withhold funds under paragraph (1) from a State for a minor failure to comply with the requirements of this part or certifications provided under section 300w−4 of this title. (b) Investigations (1) The Secretary shall conduct in several States in each fiscal year investigations of the use of funds received by the States under this part in order to evaluate compliance with the requirements of this part and certifications provided under section 300w−4 of this title. (2) The Comptroller General of the United States may conduct investigations of the use of funds received under this part by a State in order to insure compliance with the requirements of this part and certifications provided under section 300w−4 of this title. (c) Availability of books, documents, papers, and records Each State, and each entity which has received funds from an allotment made to a State under this part, shall make appropriate books, documents, papers, and records available to the Secretary or the Comptroller General of the United States, or any of their duly authorized representatives, for examination, copying, or mechanical

69

reproduction on or off the premises of the appropriate entity upon a reasonable request therefor. (d) Information not readily available (1) In conducting any investigation in a State, the Secretary or the Comptroller General of the United States may not make a request for any information not readily available to such State or an entity which has received funds from an allotment made to the State under this part or make an unreasonable request for information to be compiled, collected, or transmitted in any form not readily available. (2) Paragraph (1) does not apply to the collection, compilation, or transmittal of data in the course of a judicial proceeding. −SOURCE− (July 1, 1944, ch. 373, title XIX, Sec. 1907, as added Pub. L. 97−35, title IX, Sec. 901, Aug. 13, 1981, 95 Stat. 541.) −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in sections 300w−4, 9875 of this title. −End− −CITE− 42 USC Sec. 300w−7 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XVII − BLOCK GRANTS

70

Part A − Preventive Health and Health Services Block Grants −HEAD− Sec. 300w−7. Nondiscrimination provisions −STATUTE− (a) Programs and activities receiving Federal financial assistance (1) For the purpose of applying the prohibitions against discrimination on the basis of age under the Age Discrimination Act of 1975 [42 U.S.C. 6101 et seq.], on the basis of handicap under section 504 of the Rehabilitation Act of 1973 [29 U.S.C. 794], on the basis of sex under title IX of the Education Amendments of 1972 [20 U.S.C. 1681 et seq.], or on the basis of race, color, or national origin under title VI of the Civil Rights Act of 1964 [42 U.S.C. 2000d et seq.], programs and activities funded in whole or in part with funds made available under this part are considered to be programs and activities receiving Federal financial assistance. (2) No person shall on the ground of sex or religion be excluded from participation in, be denied the benefits of, or be subjected to discrimination under, any program or activity funded in whole or in part with funds made available under this part. (b) Failure to comply Whenever the Secretary finds that a State, or an entity that has received a payment from an allotment to a State under section 300w−1 of this title, has failed to comply with a provision of law referred to in subsection (a)(1) of this section, with subsection (a)(2) of this section, or with an applicable regulation (including one prescribed to carry out subsection (a)(2) of this section), the

71

Secretary shall notify the chief executive officer of the State and shall request him to secure compliance. If within a reasonable period of time, not to exceed sixty days, the chief executive officer fails or refuses to secure compliance, the Secretary may − (1) refer the matter to the Attorney General with a recommendation that an appropriate civil action be instituted, (2) exercise the powers and functions provided by title VI of the Civil Rights Act of 1964 [42 U.S.C. 2000d et seq.], the Age Discrimination Act of 1975 [42 U.S.C. 6101 et seq.], or section 504 of the Rehabilitation Act of 1973 [29 U.S.C. 794], as may be applicable, or (3) take such other action as may be provided by law. (c) Civil actions by Attorney General When a matter is referred to the Attorney General pursuant to subsection (b)(1) of this section, or whenever he has reason to believe that a State or an entity is engaged in a pattern or practice in violation of a provision of law referred to in subsection (a)(1) of this section or in violation of subsection (a)(2) of this section, the Attorney General may bring a civil action in any appropriate district court of the United States for such relief as may be appropriate, including injunctive relief. −SOURCE− (July 1, 1944, ch. 373, title XIX, Sec. 1908, as added Pub. L. 97−35, title IX, Sec. 901, Aug. 13, 1981, 95 Stat. 542.) −REFTEXT− REFERENCES IN TEXT

72

The Age Discrimination Act of 1975, referred to in subsecs. (a)(1) and (b)(2), is title III of Pub. L. 94−135, Nov. 28, 1975, 89 Stat. 728, as amended, which is classified generally to chapter 76 (Sec. 6101 et seq.) of this title. For complete classification of this Act to the Code, see Short Title note set out under section 6101 of this title and Tables. The Education Amendments of 1972, referred to in subsec. (a)(1), is Pub. L. 92−318, June 23, 1972, 86 Stat. 235, as amended. Title IX of the Act, known as the Patsy Takemoto Mink Equal Opportunity in Education Act, is classified principally to chapter 38 (Sec. 1681 et seq.) of Title 20, Education. For complete classification of title IX to the Code, see Short Title note set out under section 1681 of Title 20 and Tables. The Civil Rights Act of 1964, referred to in subsecs. (a)(1) and (b)(2), is Pub. L. 88−352, July 2, 1964, 78 Stat. 241, as amended. Title VI of the Civil Rights Act of 1964 is classified generally to subchapter V (Sec. 2000d et seq.) of chapter 21 of this title. For complete classification of this Act to the Code, see Short Title note set out under section 2000a of this title and Tables. −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in section 9875 of this title. −End− −CITE− 42 USC Sec. 300w−8 01/06/03 −EXPCITE−

73

TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XVII − BLOCK GRANTS Part A − Preventive Health and Health Services Block Grants −HEAD− Sec. 300w−8. Criminal penalty for false statements −STATUTE− Whoever − (1) knowingly and willfully makes or causes to be made any false statement or representation of a material fact in connection with the furnishing of items or services for which payment may be made by a State from funds allotted to the State under this part, or (2) having knowledge of the occurrence of any event affecting his initial or continued right to any such payment conceals or fails to disclose such event with an intent fraudulently to secure such payment either in a greater amount than is due or when no such payment is authorized, shall be fined not more than $25,000 or imprisoned for not more than five years, or both. −SOURCE− (July 1, 1944, ch. 373, title XIX, Sec. 1909, as added Pub. L. 97−35, title IX, Sec. 901, Aug. 13, 1981, 95 Stat. 542.) −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in section 9875 of this title.

74

−End− −CITE− 42 USC Sec. 300w−9 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XVII − BLOCK GRANTS Part A − Preventive Health and Health Services Block Grants −HEAD− Sec. 300w−9. Emergency medical services for children −STATUTE− (a) Grant authority For activities in addition to the activities which may be carried out by States under section 300w−3(a)(1)(F) (!1) of this title, the Secretary may make grants to States or accredited schools of medicine in States to support a program of demonstration projects for the expansion and improvement of emergency medical services for children who need treatment for trauma or critical care. Any grant made under this subsection shall be for not more than a 3−year period (with an optional 4th year based on performance), subject to annual evaluation by the Secretary. Only 3 grants under this subsection may be made in a State (to a State or to a school of medicine in such State) in any fiscal year. (b) Renewals The Secretary may renew a grant made under subsection (a) of this section for one additional one−year period only if the Secretary

75

determines that renewal of such grant will provide significant benefits through the collection, analysis, and dissemination of information or data which will be useful to States in which grants under such subsection have not been made. (c) Definitions For purposes of this section − (1) the term "school of medicine" has the same meaning as in section 292a(4) (!1) of this title; and (2) the term "accredited" has the same meaning as in section 292a(5) (!1) of this title. (d) Authorization of appropriations To carry out this section, there are authorized to be appropriated $2,000,000 for fiscal year 1985 and for each of the two succeeding fiscal years, $3,000,000 for fiscal year 1989, $4,000,000 for fiscal year 1990, $5,000,000 for each of the fiscal years 1991 and 1992, and such sums as may be necessary for each of the fiscal years 1993 through 2005. −SOURCE− (July 1, 1944, ch. 373, title XIX, Sec. 1910, as added Pub. L. 98−555, Sec. 7, Oct. 30, 1984, 98 Stat. 2856; amended Pub. L. 99−272, title XVII, Sec. 17004, Apr. 7, 1986, 100 Stat. 360; Pub. L. 100−607, title III, Sec. 302, Nov. 4, 1988, 102 Stat. 3112; Pub. L. 101−590, Sec. 5, Nov. 16, 1990, 104 Stat. 2928; Pub. L. 102−410, Sec. 11, Oct. 13, 1992, 106 Stat. 2101; Pub. L. 105−392, title IV, Sec. 415, Nov. 13, 1998, 112 Stat. 3590.) −REFTEXT−

76

REFERENCES IN TEXT Section 300w−3(a)(1) of this title, referred to in subsec. (a), was amended generally by Pub. L. 102−531, title I, Sec. 102(a), Oct. 27, 1992, 106 Stat. 3470, and, as so amended, provisions formerly appearing in subpar. (F) are contained in subpar. (C). Section 292a of this title, referred to in subsec. (c), was in the original a reference to section 701 of act July 1, 1944. Section 701 of that Act was omitted in the general revision of subchapter V of this chapter by Pub. L. 102−408, title I, Sec. 102, Oct. 13, 1992, 106 Stat. 1994. Pub. L. 102−408 enacted a new section 701 of act July 1, 1944, relating to statement of purpose, and a new section 702, relating to scope and duration of loan insurance program, which are classified to sections 292 and 292a, respectively, of this title. For provisions relating to definitions, see section 295p of this title. −MISC1− AMENDMENTS 1998 − Subsec. (a). Pub. L. 105−392, Sec. 415(1), substituted "3−year period (with an optional 4th year based on performance)" for "two−year period" and "3 grants" for "one grant". Subsec. (d). Pub. L. 105−392, Sec. 415(2), substituted "2005" for "1997". 1992 − Subsec. (a). Pub. L. 102−410, Sec. 11(1), substituted "grants" for "not more than four grants in any fiscal year" after "Secretary may make" in first sentence. Subsec. (d). Pub. L. 102−410, Sec. 11(2), substituted

77

"$5,000,000" for "and $5,000,000" and inserted before period ", and such sums as may be necessary for each of the fiscal years 1993 through 1997". 1990 − Subsec. (a). Pub. L. 101−590, Sec. 5(1)(A), which directed the substitution of "grants" for "not more that four grants in any fiscal year" could not be executed because the language to be stricken did not appear in text. Pub. L. 101−590, Sec. 5(1)(B), struck out "in such States" after "demonstration projects" in first sentence. Subsec. (d). Pub. L. 101−590, Sec. 5(2), substituted "each of the fiscal years 1991 and 1992" for "fiscal year 1991". 1988 − Subsec. (a). Pub. L. 100−607, Sec. 302(a), substituted "shall be for not more than a two−year period, subject to annual evaluation by the Secretary" for "shall be for a one−year period". Subsec. (d). Pub. L. 100−607, Sec. 302(b), inserted ", $3,000,000 for fiscal year 1989, $4,000,000 for fiscal year 1990, and $5,000,000 for fiscal year 1991" before period at end. 1986 − Subsec. (a). Pub. L. 99−272, Sec. 17004(1), which directed substitution of "not more than four grants in any fiscal year to States or accredited schools of medicine in States" for "grant to not more than four States in any fiscal year" was made by substituting former phrase for "grants to not more than four States in any fiscal year", as the probable intent of Congress. Pub. L. 99−272, Sec. 17004(2), inserted at end "Only one grant under this subsection may be made in a State (to a State or to a school of medicine in such State) in any fiscal year."

78

Subsec. (b). Pub. L. 99−272, Sec. 17004(3), substituted "States in which grants under such subsection have not been made" for "other States". Subsecs. (c), (d). Pub. L. 99−272, Sec. 17004(4), (5), added subsec. (c) and redesignated former subsec. (c) as (d). −FOOTNOTE− (!1) See References in Text note below. −End− −CITE− 42 USC Sec. 300w−10 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XVII − BLOCK GRANTS Part A − Preventive Health and Health Services Block Grants −HEAD− Sec. 300w−10. Repealed. Pub. L. 106−386, div. B, title IV, Sec. 1401(b), Oct. 28, 2000, 114 Stat. 1513 −MISC1− Section, act July 1, 1944, ch. 373, title XIX, Sec. 1910A, as added Pub. L. 103−322, title IV, Sec. 40151, Sept. 13, 1994, 108 Stat. 1920, related to use of allotments for rape prevention education. See section 280b−1c of this title. A prior section 300w−10, act July 1, 1944, ch. 373, title XIX, Sec. 1910A, as added Oct. 30, 1984, Pub. L. 98−555, Sec. 8, 98 Stat. 2856, related to State planning grants, prior to repeal by

79

Pub. L. 100−607, title III, Sec. 303, Nov. 4, 1988, 102 Stat. 3112. −End− −CITE− 42 USC Part B − Block Grants Regarding Mental Health and Substance Abuse 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XVII − BLOCK GRANTS Part B − Block Grants Regarding Mental Health and Substance Abuse −HEAD− PART B − BLOCK GRANTS REGARDING MENTAL HEALTH AND SUBSTANCE ABUSE −SECREF− PART REFERRED TO IN OTHER SECTIONS This part is referred to in sections 290ff, 300w−3, 15025 of this title; title 7 section 2012. −End− −CITE− 42 USC subpart i − block grants for community mental health services 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XVII − BLOCK GRANTS Part B − Block Grants Regarding Mental Health and Substance Abuse subpart i − block grants for community mental health services

80

−HEAD− SUBPART I − BLOCK GRANTS FOR COMMUNITY MENTAL HEALTH SERVICES −SECREF− SUBPART REFERRED TO IN OTHER SECTIONS This subpart is referred to in section 300x−59 of this title. −End− −CITE− 42 USC Sec. 300x 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XVII − BLOCK GRANTS Part B − Block Grants Regarding Mental Health and Substance Abuse subpart i − block grants for community mental health services −HEAD− Sec. 300x. Formula grants to States −STATUTE− (a) In general For the purpose described in subsection (b) of this section, the Secretary, acting through the Director of the Center for Mental Health Services, shall make an allotment each fiscal year for each State in an amount determined in accordance with section 300x−7 of this title. The Secretary shall make a grant to the State of the allotment made for the State for the fiscal year if the State submits to the Secretary an application in accordance with section 300x−6 of this title.

81

(b) Purpose of grants A funding agreement for a grant under subsection (a) of this section is that, subject to section 300x−5 of this title, the State involved will expend the grant only for the purpose of − (1) carrying out the plan submitted under section 300x−1(a) of this title by the State for the fiscal year involved; (2) evaluating programs and services carried out under the plan; and (3) planning, administration, and educational activities related to providing services under the plan. −SOURCE− (July 1, 1944, ch. 373, title XIX, Sec. 1911, as added Pub. L. 102−321, title II, Sec. 201(2), July 10, 1992, 106 Stat. 378.) −MISC1− PRIOR PROVISIONS A prior section 300x, act July 1, 1944, ch. 373, title XIX, Sec. 1911, as added Aug. 13, 1981, Pub. L. 97−35, title IX, Sec. 901, 95 Stat. 543; amended Oct. 19, 1984, Pub. L. 98−509, title I, Secs. 101, 106(a), 98 Stat. 2353, 2358; Nov. 18, 1988, Pub. L. 100−690, title II, Sec. 2021, 102 Stat. 4194, authorized appropriations in fiscal years 1990 and 1991 for purpose of carrying out this subpart and section 290aa−11 of this title, prior to repeal by Pub. L. 102−321, Sec. 201(2). EFFECTIVE DATE Part effective July 10, 1992, with programs making awards providing financial assistance in fiscal year 1993 and subsequent

82

years effective for awards made on or after Oct. 1, 1992, and with provision that section 205(a) of Pub. L. 102−321, set out below, regarding allotments made for fiscal year 1992 under this part as in effect on the day before July 10, 1992, applies with respect to the program established in this part, see section 801(b), (d) of Pub. L. 102−321, set out as an Effective Date of 1992 Amendment note under section 236 of this title. TEMPORARY PROVISIONS REGARDING FUNDING Section 205 of Pub. L. 102−321, as amended by Pub. L. 102−352, Sec. 2(c), Aug. 26, 1992, 106 Stat. 939; Pub. L. 102−408, title III, Sec. 312, Oct. 13, 1992, 106 Stat. 2091, provided that, with respect to allotments made for fiscal year 1992 under this part, as in effect on the day before July 10, 1992, any portion of the total of such allotments that has not been paid to the States as of the first day of the fourth quarter of such fiscal year be reallotted with the result that the total allotment made for a State for fiscal year 1992 be the amount indicated for the State in a specified table, authorized Secretary of Health and Human Services to make a grant to a State of the reallotment if the State agrees that the grant be subject to all conditions upon which allotments and payments under this part, as in effect on the day before July 10, 1992, are made for fiscal 1992, with specified exceptions, permitted transfers of allotments made in fiscal years 1993 and 1994 between this part and subpart II, section 300x−21 of this title, under certain circumstances, defined terms as used, and directed funding, subject to a limitation, of a program for

83

pregnant and postpartum women for fiscal year 1993. REPORT ON ALLOTMENT FORMULA Section 707 of Pub. L. 102−321 directed Secretary of Health and Human Services to enter into a contract with National Academy of Sciences, or if such Academy declines, with another public or nonprofit private agency, for purpose of conducting a study or studies concerning statutory formulae under which funds made available under this section and section 300x−21 of this title are allocated among States and territories, specified findings to be made by the study or studies, directed Secretary to ensure that not later than 6 months after July 10, 1992, the study was completed and a report submitted to Committee on Energy and Commerce of House of Representatives and Committee on Labor and Human Resources of Senate, and directed entity preparing the report to consult with Comptroller General with Comptroller General to review the study after its submittal and within three months make appropriate recommendations concerning such report to such committees. −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in sections 290aa−2a, 290bb−31, 290ff, 300x−1, 300x−2, 300x−3, 300x−4, 300x−5, 300x−6, 300x−7, 300x−8, 300x−51, 300x−52, 300x−53, 300x−54, 300x−55, 300x−56, 300x−57, 300x−58, 300x−60, 300x−62, 300x−63, 300x−64, 300x−66 of this title. −End− −CITE−

84

42 USC Sec. 300x−1 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XVII − BLOCK GRANTS Part B − Block Grants Regarding Mental Health and Substance Abuse subpart i − block grants for community mental health services −HEAD− Sec. 300x−1. State plan for comprehensive community mental health services for certain individuals −STATUTE− (a) In general The Secretary may make a grant under section 300x of this title only if − (1) the State involved submits to the Secretary a plan for providing comprehensive community mental health services to adults with a serious mental illness and to children with a serious emotional disturbance; (2) the plan meets the criteria specified in subsection (b) of this section; and (3) the plan is approved by the Secretary. (b) Criteria for plan With respect to the provision of comprehensive community mental health services to individuals who are either adults with a serious mental illness or children with a serious emotional disturbance, the criteria referred to in subsection (a) of this section

85

regarding a plan are as follows: (1) Comprehensive community−based mental health systems The plan provides for an organized community−based system of care for individuals with mental illness and describes available services and resources in a comprehensive system of care, including services for dually diagnosed individuals. The description of the system of care shall include health and mental health services, rehabilitation services, employment services, housing services, educational services, substance abuse services, medical and dental care, and other support services to be provided to individuals with Federal, State and local public and private resources to enable such individuals to function outside of inpatient or residential institutions to the maximum extent of their capabilities, including services to be provided by local school systems under the Individuals with Disabilities Education Act [20 U.S.C. 1400 et seq.]. The plan shall include a separate description of case management services and provide for activities leading to reduction of hospitalization. (2) Mental health system data and epidemiology The plan contains an estimate of the incidence and prevalence in the State of serious mental illness among adults and serious emotional disturbance among children and presents quantitative targets to be achieved in the implementation of the system described in paragraph (1). (3) Children's services In the case of children with serious emotional disturbance, the

86

plan − (A) subject to subparagraph (B), provides for a system of integrated social services, educational services, juvenile services, and substance abuse services that, together with health and mental health services, will be provided in order for such children to receive care appropriate for their multiple needs (such system to include services provided under the Individuals with Disabilities Education Act [20 U.S.C. 1400 et seq.]); (B) provides that the grant under section 300x of this title for the fiscal year involved will not be expended to provide any service under such system other than comprehensive community mental health services; and (C) provides for the establishment of a defined geographic area for the provision of the services of such system. (4) Targeted services to rural and homeless populations The plan describes the State's outreach to and services for individuals who are homeless and how community−based services will be provided to individuals residing in rural areas. (5) Management systems The plan describes the financial resources, staffing and training for mental health providers that is necessary to implement the plan, and provides for the training of providers of emergency health services regarding mental health. The plan further describes the manner in which the State intends to expend the grant under section 300x of this title for the fiscal year

87

involved. Except as provided for in paragraph (3), the State plan shall contain the information required under this subsection with respect to both adults with serious mental illness and children with serious emotional disturbance. (c) Definitions regarding mental illness and emotional disturbance; methods for estimate of incidence and prevalence (1) Establishment by Secretary of definitions; dissemination For purposes of this subpart, the Secretary shall establish definitions for the terms "adults with a serious mental illness" and "children with a serious emotional disturbance". The Secretary shall disseminate the definitions to the States. (2) Standardized methods The Secretary shall establish standardized methods for making the estimates required in subsection (b)(11) (!1) of this section with respect to a State. A funding agreement for a grant under section 300x of this title for the State is that the State will utilize such methods in making the estimates. (3) Date certain for compliance by Secretary Not later than 90 days after July 10, 1992, the Secretary shall establish the definitions described in paragraph (1), shall begin dissemination of the definitions to the States, and shall establish the standardized methods described in paragraph (2). (d) Requirement of implementation of plan (1) Complete implementation Except as provided in paragraph (2), in making a grant under

88

section 300x of this title to a State for a fiscal year, the Secretary shall make a determination of the extent to which the State has implemented the plan required in subsection (a) of this section. If the Secretary determines that a State has not completely implemented the plan, the Secretary shall reduce the amount of the allotment under section 300x of this title for the State for the fiscal year involved by an amount equal to 10 percent of the amount determined under section 300x−7 of this title for the State for the fiscal year. (2) Substantial implementation and good faith effort regarding fiscal year 1993 (A) In making a grant under section 300x of this title to a State for fiscal year 1993, the Secretary shall make a determination of the extent to which the State has implemented the plan required in subsection (a) of this section. If the Secretary determines that the State has not substantially implemented the plan, the Secretary shall, subject to subparagraph (B), reduce the amount of the allotment under section 300x of this title for the State for such fiscal year by an amount equal to 10 percent of the amount determined under section 300x−7 of this title for the State for the fiscal year. (B) In carrying out subparagraph (A), if the Secretary determines that the State is making a good faith effort to implement the plan required in subsection (a) of this section, the Secretary may make a reduction under such subparagraph in an amount that is less than the amount specified in such

89

subparagraph, except that the reduction may not be made in an amount that is less than 5 percent of the amount determined under section 300x−7 of this title for the State for fiscal year 1993. −SOURCE− (July 1, 1944, ch. 373, title XIX, Sec. 1912, as added Pub. L. 102−321, title II, Sec. 201(2), July 10, 1992, 106 Stat. 379; amended Pub. L. 106−310, div. B, title XXXII, Sec. 3204(a), Oct. 17, 2000, 114 Stat. 1192.) −REFTEXT− REFERENCES IN TEXT The Individuals with Disabilities Education Act, referred to in subsec. (b)(1), (3)(A), is title VI of Pub. L. 91−230, Apr. 13, 1970, 84 Stat. 175, as amended, which is classified generally to chapter 33 (Sec. 1400 et seq.) of Title 20, Education. For complete classification of this Act to the Code, see section 1400 of Title 20 and Tables. Subsection (b)(11) of this section, referred to in subsec. (c)(2), was repealed by Pub. L. 106−310, div. B, title XXXII, Sec. 3204(a), Oct. 17, 2000, 114 Stat. 1192. Provisions relating to estimates formerly contained in subsec. (b)(11) are now contained in subsec. (b)(2) of this section. −MISC1− PRIOR PROVISIONS Prior sections 300x−1 to 300x−1b were repealed by Pub. L. 102−321, title II, Sec. 201(2), July 10, 1992, 106 Stat. 378. Section 300x−1, act July 1, 1944, ch. 373, title XIX, Sec. 1912,

90

as added Oct. 19, 1984, Pub. L. 98−509, title I, Sec. 102(a), 98 Stat. 2353, authorized grants for training of employees adversely affected by changes in delivery of mental health services and for providing assistance in securing employment. Another prior section 300x−1, act July 1, 1944, ch. 373, title XIX, Sec. 1912, as added Aug. 13, 1981, Pub. L. 97−35, title IX, Sec. 901, 95 Stat. 543; amended Jan. 4, 1983, Pub. L. 97−414, Sec. 8(t), 96 Stat. 2062; Oct. 19, 1984, Pub. L. 98−509, title I, Sec. 106(e), 98 Stat. 2358, contained provisions relating to grants and allotment of grants for alcohol, drug abuse, and mental health services, prior to repeal by section 102(a) of Pub. L. 98−509. Section 300x−1a, act July 1, 1944, ch. 373, title XIX, Sec. 1912A, as added and amended Nov. 18, 1988, Pub. L. 100−690, title II, Secs. 2022(a)−(c), 2023, 102 Stat. 4194, 4196, 4197; Aug. 16, 1989, Pub. L. 101−93, Sec. 2(a), 103 Stat. 603, related to allotments of grants for alcohol, drug abuse, and mental health services. Another prior section 300x−1a, act July 1, 1944, ch. 373, title XIX, Sec. 1913, as added Oct. 19, 1984, Pub. L. 98−509, title I, Sec. 102(a), 98 Stat. 2353, was transferred to section 300x−1b of this title. Section 300x−1b, act July 1, 1944, ch. 373, title XIX, Sec. 1913, as added Oct. 19, 1984, Pub. L. 98−509, title I, Sec. 102(a), 98 Stat. 2353; amended Nov. 18, 1988, Pub. L. 100−690, title II, Sec. 2022(d), 102 Stat. 4197; Aug. 16, 1989, Pub. L. 101−93, Sec. 2(b), 103 Stat. 605, related to allotments to States and Indian tribes or

91

tribal organizations for alcohol, drug abuse, and mental health services. AMENDMENTS 2000 − Subsec. (b). Pub. L. 106−310 added pars. (1) to (5) and concluding provisions and struck out former pars. (1) to (12) relating to criteria for plan. −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in sections 300x, 300x−2, 300x−4, 300x−6, 300x−8, 300x−51, 300x−54, 300x−55 of this title. −FOOTNOTE− (!1) See References in Text note below. −End− −CITE− 42 USC Sec. 300x−2 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XVII − BLOCK GRANTS Part B − Block Grants Regarding Mental Health and Substance Abuse subpart i − block grants for community mental health services −HEAD− Sec. 300x−2. Certain agreements −STATUTE− (a) Allocation for systems of integrated services for children (1) In general

92

With respect to children with a serious emotional disturbance, a funding agreement for a grant under section 300x of this title is that − (A) in the case of a grant for fiscal year 1993, the State involved will expend not less than 10 percent of the grant to increase (relative to fiscal year 1992) funding for the system of integrated services described in section 300x−1(b)(9) (!1) of this title; (B) in the case of a grant for fiscal year 1994, the State will expend not less than 10 percent of the grant to increase (relative to fiscal year 1993) funding for such system; and (C) in the case of a grant for any subsequent fiscal year, the State will expend for such system not less than an amount equal to the amount expended by the State for fiscal year 1994. (2) Waiver (A) Upon the request of a State, the Secretary may provide to the State a waiver of all or part of the requirement established in paragraph (1) if the Secretary determines that the State is providing an adequate level of comprehensive community mental health services for children with a serious emotional distrubance,(!2) as indicated by a comparison of the number of such children for which such services are sought with the availability in the State of the services. (B) The Secretary shall approve or deny a request for a waiver under subparagraph (A) not later than 120 days after the date on which the request is made.

93

(C) Any waiver provided by the Secretary under subparagraph (A) shall be applicable only to the fiscal year involved. (b) Providers of services A funding agreement for a grant under section 300x of this title for a State is that, with respect to the plan submitted under section 300x−1(a) of this title for the fiscal year involved − (1) services under the plan will be provided only through appropriate, qualified community programs (which may include community mental health centers, child mental−health programs, psychosocial rehabilitation programs, mental health peer−support programs, and mental−health primary consumer−directed programs); and (2) services under the plan will be provided through community mental health centers only if the centers meet the criteria specified in subsection (c) of this section. (c) Criteria for mental health centers The criteria referred to in subsection (b)(2) of this section regarding community mental health centers are as follows: (1) With respect to mental health services, the centers provide services as follows: (A) Services principally to individuals residing in a defined geographic area (hereafter in this subsection referred to as a "service area"). (B) Outpatient services, including specialized outpatient services for children, the elderly, individuals with a serious mental illness, and residents of the service areas of the

94

centers who have been discharged from inpatient treatment at a mental health facility. (C) 24−hour−a−day emergency care services. (D) Day treatment or other partial hospitalization services, or psychosocial rehabilitation services. (E) Screening for patients being considered for admission to State mental health facilities to determine the appropriateness of such admission. (2) The mental health services of the centers are provided, within the limits of the capacities of the centers, to any individual residing or employed in the service area of the center regardless of ability to pay for such services. (3) The mental health services of the centers are available and accessible promptly, as appropriate and in a manner which preserves human dignity and assures continuity and high quality care. −SOURCE− (July 1, 1944, ch. 373, title XIX, Sec. 1913, as added Pub. L. 102−321, title II, Sec. 201(2), July 10, 1992, 106 Stat. 381.) −REFTEXT− REFERENCES IN TEXT Section 300x−1(b)(9) of this title, referred to in subsec. (a)(1)(A), was repealed by Pub. L. 106−310, div. B, title XXXII, Sec. 3204(a), Oct. 17, 2000, 114 Stat. 1192. Provisions relating to a system of integrated social services formerly contained in section 300x−1(b)(9) are now contained in section 300x−1(b)(3) of

95

this title. −MISC1− PRIOR PROVISIONS A prior section 300x−2, act July 1, 1944, ch. 373, title XIX, Sec. 1914, formerly Sec. 1913, as added Aug. 13, 1981, Pub. L. 97−35, title IX, Sec. 901, 95 Stat. 545; renumbered Sec. 1914 and amended Oct. 19, 1984, Pub. L. 98−509, title I, Sec. 106(a), (c)−(e), (g), 98 Stat. 2358, 2359; Nov. 18, 1988, Pub. L. 100−690, title II, Sec. 2022(e), 102 Stat. 4197; Aug. 16, 1989, Pub. L. 101−93, Sec. 2(c)(1), 103 Stat. 605, related to payment to States of allotments of grants for alcohol, drug abuse, and mental health services, prior to repeal by Pub. L. 102−321, Sec. 201(2). A prior section 1913 of act July 1, 1944, was classified to section 300x−1b of this title and repealed by Pub. L. 102−321. −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in section 1395x of this title. −FOOTNOTE− (!1) See References in Text note below. (!2) So in original. Probably should be "disturbance,". −End− −CITE− 42 USC Sec. 300x−3 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE

96

SUBCHAPTER XVII − BLOCK GRANTS Part B − Block Grants Regarding Mental Health and Substance Abuse subpart i − block grants for community mental health services −HEAD− Sec. 300x−3. State mental health planning council −STATUTE− (a) In general A funding agreement for a grant under section 300x of this title is that the State involved will establish and maintain a State mental health planning council in accordance with the conditions described in this section. (b) Duties A condition under subsection (a) of this section for a Council is that the duties of the Council are − (1) to review plans provided to the Council pursuant to section 300x−4(a) of this title by the State involved and to submit to the State any recommendations of the Council for modifications to the plans; (2) to serve as an advocate for adults with a serious mental illness, children with a severe emotional disturbance, and other individuals with mental illnesses or emotional problems; and (3) to monitor, review, and evaluate, not less than once each year, the allocation and adequacy of mental health services within the State. (c) Membership (1) In general

97

A condition under subsection (a) of this section for a Council is that the Council be composed of residents of the State, including representatives of − (A) the principal State agencies with respect to − (i) mental health, education, vocational rehabilitation, criminal justice, housing, and social services; and (ii) the development of the plan submitted pursuant to title XIX of the Social Security Act [42 U.S.C. 1396 et seq.]; (B) public and private entities concerned with the need, planning, operation, funding, and use of mental health services and related support services; (C) adults with serious mental illnesses who are receiving (or have received) mental health services; and (D) the families of such adults or families of children with emotional disturbance. (2) Certain requirements A condition under subsection (a) of this section for a Council is that − (A) with respect to the membership of the Council, the ratio of parents of children with a serious emotional disturbance to other members of the Council is sufficient to provide adequate representation of such children in the deliberations of the Council; and (B) not less than 50 percent of the members of the Council are individuals who are not State employees or providers of

98

mental health services. (d) "Council" defined For purposes of this section, the term "Council" means a State mental health planning council. −SOURCE− (July 1, 1944, ch. 373, title XIX, Sec. 1914, as added Pub. L. 102−321, title II, Sec. 201(2), July 10, 1992, 106 Stat. 382.) −REFTEXT− REFERENCES IN TEXT The Social Security Act, referred to in subsec. (c)(1)(A)(ii), is act Aug. 14, 1935, ch. 531, 49 Stat. 620, as amended. Title XIX of the Act is classified generally to subchapter XIX (Sec. 1396 et seq.) of chapter 7 of this title. For complete classification of this Act to the Code, see section 1305 of this title and Tables. −MISC1− PRIOR PROVISIONS A prior section 300x−3, act July 1, 1944, ch. 373, title XIX, Sec. 1915, formerly Sec. 1914, as added Aug. 13, 1981, Pub. L. 97−35, title IX, Sec. 901, 95 Stat. 545; renumbered Sec. 1915 and amended Oct. 19, 1984, Pub. L. 98−509, title I, Secs. 105(b), 106(a), (b), (d), (g), 98 Stat. 2358, 2359; Nov. 18, 1988, Pub. L. 100−690, title II, Secs. 2024−2026, 102 Stat. 4198, 4199; Aug. 16, 1989, Pub. L. 101−93, Sec. 2(d), 103 Stat. 606; Nov. 28, 1990, Pub. L. 101−639, Sec. 3(a)(2), 104 Stat. 4601, related to the use of grant allotments for alcohol, drug abuse, and mental health services, prior to repeal by Pub. L. 102−321, Sec. 201(2).

99

A prior section 1914 of act July 1, 1944, was classified to section 300x−2 of this title prior to repeal by Pub. L. 102−321. −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in section 300x−4 of this title; title 29 section 725. −End− −CITE− 42 USC Sec. 300x−4 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XVII − BLOCK GRANTS Part B − Block Grants Regarding Mental Health and Substance Abuse subpart i − block grants for community mental health services −HEAD− Sec. 300x−4. Additional provisions −STATUTE− (a) Review of State plan by mental health planning council The Secretary may make a grant under section 300x of this title to a State only if − (1) the plan submitted under section 300x−1(a) of this title with respect to the grant and the report of the State under section 300x−52(a) of this title concerning the preceding fiscal year has been reviewed by the State mental health planning council under section 300x−3 of this title; and

100

(2) the State submits to the Secretary any recommendations received by the State from such council for modifications to the plan (without regard to whether the State has made the recommended modifications) and any comments concerning the annual report. (b) Maintenance of effort regarding State expenditures for mental health (1) In general A funding agreement for a grant under section 300x of this title is that the State involved will maintain State expenditures for community mental health services at a level that is not less than the average level of such expenditures maintained by the State for the 2−year period preceding the fiscal year for which the State is applying for the grant. (2) Exclusion of certain funds The Secretary may exclude from the aggregate State expenditures under subsection (a) of this section, funds appropriated to the principle agency for authorized activities which are of a non−recurring nature and for a specific purpose. (3) Waiver The Secretary may, upon the request of a State, waive the requirement established in paragraph (1) if the Secretary determines that extraordinary economic conditions in the State justify the waiver. (4) Noncompliance by State (A) In making a grant under section 300x of this title to a

101

State for a fiscal year, the Secretary shall make a determination of whether, for the previous fiscal year, the State maintained material compliance with the agreement made under paragraph (1). If the Secretary determines that a State has failed to maintain such compliance, the Secretary shall reduce the amount of the allotment under section 300x of this title for the State for the fiscal year for which the grant is being made by an amount equal to the amount constituting such failure for the previous fiscal year. (B) The Secretary may make a grant under section 300x of this title for a fiscal year only if the State involved submits to the Secretary information sufficient for the Secretary to make the determination required in subparagraph (A). −SOURCE− (July 1, 1944, ch. 373, title XIX, Sec. 1915, as added Pub. L. 102−321, title II, Sec. 201(2), July 10, 1992, 106 Stat. 383; amended Pub. L. 106−310, div. B, title XXXII, Sec. 3204(b), (c), Oct. 17, 2000, 114 Stat. 1193.) −MISC1− PRIOR PROVISIONS Prior sections 300x−4 and 300x−4a were repealed by Pub. L. 102−321, title II, Sec. 201(2), July 10, 1992, 106 Stat. 378. Section 300x−4, act July 1, 1944, ch. 373, title XIX, Sec. 1916, formerly Sec. 1915, as added Aug. 13, 1981, Pub. L. 97−35, title IX, Sec. 901, 95 Stat. 546; amended Jan. 4, 1983, Pub. L. 97−414, Sec. 8(u), 96 Stat. 2063; renumbered Sec. 1916 and amended Oct. 19,

102

1984, Pub. L. 98−509, title I, Secs. 103, 106(a)−(c), (f), (g), 98 Stat. 2355, 2358, 2359; Oct. 7, 1985, Pub. L. 99−117, Sec. 7(a), 99 Stat. 492; Nov. 14, 1986, Pub. L. 99−660, title V, Sec. 503, 100 Stat. 3797; Nov. 18, 1988, Pub. L. 100−690, title II, Secs. 2027−2035, 2037(a)(2), 102 Stat. 4199−4201, 4203; Aug. 16, 1989, Pub. L. 101−93, Sec. 2(e)−(l), (p)(1), (q)(1), 103 Stat. 606−609; Aug. 15, 1990, Pub. L. 101−374, Sec. 4(b), 104 Stat. 459, required States to make application and describe their activities in relation to allotments for grants for alcohol, drug abuse, and mental health services. A prior section 1915 of act July 1, 1944, was classified to section 300x−3 of this title prior to repeal by Pub. L. 102−321. Section 300x−4a, act July 1, 1944, ch. 373, title XIX, Sec. 1916A, as added Nov. 18, 1988, Pub. L. 100−690, title II, Sec. 2036, 102 Stat. 4202; amended Aug. 16, 1989, Pub. L. 101−93, Sec. 2(m), 103 Stat. 608, related to group homes for recovering substance abusers. AMENDMENTS 2000 − Subsec. (a)(1). Pub. L. 106−310, Sec. 3204(b)(1), inserted "and the report of the State under section 300x−52(a) of this title concerning the preceding fiscal year" after "to the grant". Subsec. (a)(2). Pub. L. 106−310, Sec. 3204(b)(2), inserted "and any comments concerning the annual report" before period at end. Subsec. (b)(2) to (4). Pub. L. 106−310, Sec. 3204(c), added par. (2) and redesignated former pars. (2) and (3) as (3) and (4), respectively.

103

−SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in sections 300x−3, 300x−6, 300x−24, 300x−54, 300x−55 of this title. −End− −CITE− 42 USC Sec. 300x−5 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XVII − BLOCK GRANTS Part B − Block Grants Regarding Mental Health and Substance Abuse subpart i − block grants for community mental health services −HEAD− Sec. 300x−5. Restrictions on use of payments −STATUTE− (a) In general A funding agreement for a grant under section 300x of this title is that the State involved will not expend the grant − (1) to provide inpatient services; (2) to make cash payments to intended recipients of health services; (3) to purchase or improve land, purchase, construct, or permanently improve (other than minor remodeling) any building or other facility, or purchase major medical equipment; (4) to satisfy any requirement for the expenditure of

104

non−Federal funds as a condition for the receipt of Federal funds; or (5) to provide financial assistance to any entity other than a public or nonprofit private entity. (b) Limitation on administrative expenses A funding agreement for a grant under section 300x of this title is that the State involved will not expend more than 5 percent of the grant for administrative expenses with respect to the grant. −SOURCE− (July 1, 1944, ch. 373, title XIX, Sec. 1916, as added Pub. L. 102−321, title II, Sec. 201(2), July 10, 1992, 106 Stat. 384.) −MISC1− PRIOR PROVISIONS A prior section 300x−5, act July 1, 1944, ch. 373, title XIX, Sec. 1917, formerly Sec. 1916, as added Aug. 13, 1981, Pub. L. 97−35, title IX, Sec. 901, 95 Stat. 549; renumbered Sec. 1917 and amended Oct. 19, 1984, Pub. L. 98−509, title I, Secs. 104, 106(a), (b), (d), (g), 98 Stat. 2357−2359; Oct. 7, 1985, Pub. L. 99−117, Sec. 7(b), 99 Stat. 493; Nov. 18, 1988, Pub. L. 100−690, title II, Secs. 2037(a)(1), (b), 2052(b), 102 Stat. 4203, 4208; Aug. 16, 1989, Pub. L. 101−93, Sec. 2(p)(2), 103 Stat. 609, related to reports and audits relative to grants for alcohol, drug abuse, and mental health services, prior to repeal by Pub. L. 102−321, Sec. 201(2). A prior section 1916 of act July 1, 1944, was classified to section 300x−4 of this title prior to repeal by Pub. L. 102−321.

105

−SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in sections 300x, 300x−6 of this title. −End− −CITE− 42 USC Sec. 300x−6 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XVII − BLOCK GRANTS Part B − Block Grants Regarding Mental Health and Substance Abuse subpart i − block grants for community mental health services −HEAD− Sec. 300x−6. Application for grant −STATUTE− (a) In general For purposes of section 300x of this title, an application for a grant under such section for a fiscal year in accordance with this section if, subject to subsection (b) of this section − (1) the plan is received by the Secretary not later than September 1 of the fiscal year prior to the fiscal year for which a State is seeking funds, and the report from the previous fiscal year as required under section 300x−51 of this title is received by December 1 of the fiscal year of the grant; (2) the application contains each funding agreement that is

106

described in this subpart or subpart III for such a grant (other than any such agreement that is not applicable to the State); (3) the agreements are made through certification from the chief executive officer of the State; (4) with respect to such agreements, the application provides assurances of compliance satisfactory to the Secretary; (5) the application contains the plan required in section 300x−1(a) of this title, the information required in section 300x−4(b)(3)(B) (!1) of this title, and the report required in section 300x−52(a) of this title; (6) the application contains recommendations in compliance with section 300x−4(a) of this title, or if no such recommendations are received by the State, the application otherwise demonstrates compliance with such section; and (7) the application (including the plan under section 300x−1(a) of this title) is otherwise in such form, is made in such manner, and contains such agreements, assurances, and information as the Secretary determines to be necessary to carry out this subpart. (b) Waivers regarding certain territories In the case of any territory of the United States except Puerto Rico, the Secretary may waive such provisions of this subpart and subpart III as the Secretary determines to be appropriate, other than the provisions of section 300x−5 of this title. −SOURCE− (July 1, 1944, ch. 373, title XIX, Sec. 1917, as added Pub. L. 102−321, title II, Sec. 201(2), July 10, 1992, 106 Stat. 384;

107

amended Pub. L. 106−310, div. B, title XXXII, Sec. 3204(d), (e), Oct. 17, 2000, 114 Stat. 1193.) −REFTEXT− REFERENCES IN TEXT Section 300x−4(b)(3)(B) of this title, referred to in subsec. (a)(5), was redesignated section 300x−4(b)(4)(B) by Pub. L. 106−310, div. B, title XXXII, Sec. 3204(c)(1), Oct. 17, 2000, 114 Stat. 1193. −MISC1− PRIOR PROVISIONS A prior section 300x−6, act July 1, 1944, ch. 373, title XIX, Sec. 1918, formerly Sec. 1917, as added Aug. 13, 1981, Pub. L. 97−35, title IX, Sec. 901, 95 Stat. 550; renumbered Sec. 1918 and amended Oct. 19, 1984, Pub. L. 98−509, title I, Sec. 106(d), (g), 98 Stat. 2358, 2359, authorized withholding funds from States which did not use allotments of grants for alcohol, drug abuse, and mental health services in accordance with requirements, prior to repeal by Pub. L. 102−321, Sec. 201(2). A prior section 1917 of act July 1, 1944, was classified to section 300x−5 of this title prior to repeal by Pub. L. 102−321. AMENDMENTS 2000 − Subsec. (a)(1). Pub. L. 106−310, Sec. 3204(d), amended par. (1) generally. Prior to amendment, par. (1) read as follows: "the State involved submits the application not later than the date specified by the Secretary as being the date after which applications for such a grant will not be considered (in any case

108

in which the Secretary specifies such a date);". Subsec. (b). Pub. L. 106−310, Sec. 3204(e), substituted "except Puerto Rico" for "whose allotment under section 300x of this title for the fiscal year is the amount specified in section 300x−7(c)(2)(B) of this title". −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in section 300x of this title. −FOOTNOTE− (!1) See References in Text note below. −End− −CITE− 42 USC Sec. 300x−7 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XVII − BLOCK GRANTS Part B − Block Grants Regarding Mental Health and Substance Abuse subpart i − block grants for community mental health services −HEAD− Sec. 300x−7. Determination of amount of allotment −STATUTE− (a) States (1) Determination under formula Subject to subsection (b) of this section, the Secretary shall determine the amount of the allotment required in section 300x of

109

this title for a State for a fiscal year in accordance with the following formula: G7 X G7 AB U −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− (2) Determination of term "A" For purposes of paragraph (1), the term "A" means the difference between − (A) the amount appropriated under section 300x−9(a) of this title for allotments under section 300x of this title for the fiscal year involved; and (B) an amount equal to 1.5 percent of the amount referred to in subparagraph (A). (3) Determination of term "U" For purposes of paragraph (1), the term "U" means the sum of the respective terms "X" determined for the States under paragraph (4). (4) Determination of term "X" For purposes of paragraph (1), the term "X" means the product of − (A) an amount equal to the product of − (i) the term "P", as determined for the State involved under paragraph (5); and (ii) the factor determined under paragraph (8) for the

110

State; and (B) the greater of − (i) 0.4; and (ii) an amount equal to an amount determined for the State in accordance with the following formula: G7A R% G7B P% −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− (5) Determination of term "P" (A) For purposes of paragraph (4), the term "P" means the sum of − (i) an amount equal to the product of 0.107 and the number of individuals in the State who are between 18 and 24 years of age (inclusive); (ii) an amount equal to the product of 0.166 and the number of individuals in the State who are between 25 and 44 years of age (inclusive); (iii) an amount equal to the product of 0.099 and the number of individuals in the State who are between 45 and 64 years of age (inclusive); and (iv) an amount equal to the product of 0.082 and the number of individuals in the State who are 65 years of age or older. (B) With respect to data on population that is necessary for purposes of making a determination under subparagraph (A), the Secretary shall use the most recent data that is available from

111

the Secretary of Commerce pursuant to the decennial census and pursuant to reasonable estimates by such Secretary of changes occurring in the data in the ensuing period. (6) Determination of term "R%" (A) For purposes of paragraph (4), the term "R%", except as provided in subparagraph (D), means the percentage constituted by the ratio of the amount determined under subparagraph (B) for the State involved to the amount determined under subparagraph (C). (B) The amount determined under this subparagraph for the State involved is the quotient of − (i) the most recent 3−year arithmetic mean of the total taxable resources of the State, as determined by the Secretary of the Treasury; divided by (ii) the factor determined under paragraph (8) for the State. (C) The amount determined under this subparagraph is the sum of the respective amounts determined for the States under subparagraph (B) (including the District of Columbia). (D)(i) In the case of the District of Columbia, for purposes of paragraph (4), the term "R%" means the percentage constituted by the ratio of the amount determined under clause (ii) for such District to the amount determined under clause (iii). (ii) The amount determined under this clause for the District of Columbia is the quotient of − (I) the most recent 3−year arithmetic mean of total personal income in such District, as determined by the Secretary of Commerce; divided by

112

(II) the factor determined under paragraph (8) for the District. (iii) The amount determined under this clause is the sum of the respective amounts determined for the States (including the District of Columbia) by making, for each State, the same determination as is described in clause (ii) for the District of Columbia. (7) Determination of term "P%" For purposes of paragraph (4), the term "P%" means the percentage constituted by the ratio of the term "P" determined under paragraph (5) for the State involved to the sum of the respective terms "P" determined for the States. (8) Determination of certain factor (A) The factor determined under this paragraph for the State involved is a factor whose purpose is to adjust the amount determined under clause (i) of paragraph (4)(A), and the amounts determined under each of subparagraphs (B)(i) and (D)(ii)(I) of paragraph (6), to reflect the differences that exist between the State and other States in the costs of providing comprehensive community mental health services to adults with a serious mental illness and to children with a serious emotional disturbance. (B) Subject to subparagraph (C), the factor determined under this paragraph and in effect for the fiscal year involved shall be determined according to the methodology described in the report entitled "Adjusting the Alcohol, Drug Abuse and Mental Health Services Block Grant Allocations for Poverty Populations

113

and Cost of Service", dated March 30, 1990, and prepared by Health Economics Research, a corporation, pursuant to a contract with the National Institute on Drug Abuse. (C) The factor determined under this paragraph for the State involved may not for any fiscal year be greater than 1.1 or less than 0.9. (D)(i) Not later than October 1, 1992, the Secretary, after consultation with the Comptroller General, shall in accordance with this section make a determination for each State of the factor that is to be in effect for the State under this paragraph. The factor so determined shall remain in effect through fiscal year 1994, and shall be recalculated every third fiscal year thereafter. (ii) After consultation with the Comptroller General, the Secretary shall, through publication in the Federal Register, periodically make such refinements in the methodology referred to in subparagraph (B) as are consistent with the purpose described in subparagraph (A). (b) Minimum allotments for States With respect to fiscal year 2000, and subsequent fiscal years, the amount of the allotment of a State under section 300x of this title shall not be less than the amount the State received under such section for fiscal year 1998. (c) Territories (1) Determination under formula Subject to paragraphs (2) and (4), the amount of an allotment

114

under section 300x of this title for a territory of the United States for a fiscal year shall be the product of − (A) an amount equal to the amounts reserved under paragraph (3) for the fiscal year; and (B) a percentage equal to the quotient of − (i) the civilian population of the territory, as indicated by the most recently available data; divided by (ii) the aggregate civilian population of the territories of the United States, as indicated by such data. (2) Minimum allotment for territories The amount of an allotment under section 300x of this title for a territory of the United States for a fiscal year shall be the greater of − (A) the amount determined under paragraph (1) for the territory for the fiscal year; (B) $50,000; and (C) with respect to fiscal years 1993 and 1994, an amount equal to 20.6 percent of the amount received by the territory from allotments made pursuant to this part for fiscal year 1992. (3) Reservation of amounts The Secretary shall each fiscal year reserve for the territories of the United States 1.5 percent of the amounts appropriated under section 300x−9(a) of this title for allotments under section 300x of this title for the fiscal year. (4) Availability of data on population

115

With respect to data on the civilian population of the territories of the United States, if the Secretary determines for a fiscal year that recent such data for purposes of paragraph (1)(B) do not exist regarding a territory, the Secretary shall for such purposes estimate the civilian population of the territory by modifying the data on the territory to reflect the average extent of change occurring during the ensuing period in the population of all territories with respect to which recent such data do exist. (5) Applicability of certain provisions For purposes of subsection (a) of this section, the term "State" does not include the territories of the United States. −SOURCE− (July 1, 1944, ch. 373, title XIX, Sec. 1918, as added Pub. L. 102−321, title II, Sec. 201(2), July 10, 1992, 106 Stat. 385; amended Pub. L. 102−352, Sec. 2(a)(8), (9), Aug. 26, 1992, 106 Stat. 938; Pub. L. 105−277, div. A, Sec. 101(f) [title II, Sec. 218(a)], Oct. 21, 1998, 112 Stat. 2681−337, 2681−362; Pub. L. 106−113, div. B, Sec. 1000(a)(4) [title II, Sec. 212(a)], Nov. 29, 1999, 113 Stat. 1535, 1501A−239; Pub. L. 106−310, div. B, title XXXII, Sec. 3205, Oct. 17, 2000, 114 Stat. 1193.) −MISC1− PRIOR PROVISIONS A prior section 300x−7, act July 1, 1944, ch. 373, title XIX, Sec. 1919, formerly Sec. 1918, as added Aug. 13, 1981, Pub. L. 97−35, title IX, Sec. 901, 95 Stat. 551; renumbered Sec. 1919 and

116

amended Oct. 19, 1984, Pub. L. 98−509, title I, Sec. 106(a), (g), 98 Stat. 2358, 2359, related to nondiscrimination provisions with respect to alcohol, drug abuse, and mental health programs, prior to repeal by Pub. L. 102−321, Sec. 201(2). A prior section 1918 of act July 1, 1944, was classified to section 300x−6 of this title prior to repeal by Pub. L. 102−321. AMENDMENTS 2000 − Subsec. (b). Pub. L. 106−310 reenacted heading without change and amended text generally. Prior to amendment, text read as follows: "With respect to fiscal year 2000, the amount of the allotment of a State under section 300x of this title shall not be less than the amount the State received under section 300x of this title for fiscal year 1998." 1999 − Subsec. (b). Pub. L. 106−113 amended heading and text of subsec. (b) generally. Prior to amendment, text read as follows: "For each of the fiscal years 1993 and 1994, the amount of the allotment required in section 300x of this title for a State for the fiscal year involved shall be the greater of − "(1) the amount determined under subsection (a) of this section for the State for the fiscal year; and "(2) an amount equal to 20.6 percent of the amount received by the State from allotments made pursuant to this part for fiscal year 1992 (including reallotments under section 205(a) of the ADAMHA Reorganization Act)." 1998 − Subsec. (b). Pub. L. 105−277, temporarily amended subsec. (b) to read as follows: "(b) Minimum allotments for States. −

117

"(1) In general. − With respect to fiscal year 1999, the amount of the allotment of a State under section 300x of this title shall not be less than the amount the State received under section 300x of this title for fiscal year 1998." See Effective and Termination Dates of 1998 Amendment note below. 1992 − Subsec. (a)(5)(A)(iii). Pub. L. 102−352, Sec. 2(a)(8), substituted "45" for "25". Subsec. (c)(2)(C). Pub. L. 102−352, Sec. 2(a)(9), added subpar. (C). EFFECTIVE AND TERMINATION DATES OF 1998 AMENDMENT Pub. L. 105−277, div. A, Sec. 101(f) [title II, Sec. 218(c)], Oct. 21, 1998, 112 Stat. 2681−337, 2681−363, provided that: "(1) In general. − The amendments made by subsections (a) and (b) [amending this section and section 300x−33 of this title] shall become effective as if enacted on October 1, 1998 and shall only apply during fiscal year 1999. "(2) Application. − Upon the expiration of the fiscal year described in paragraph (1), the provisions of sections 1918(b) and 1933(b) of the Public Health Service Act (42 U.S.C. 300x−7(b) and 300x−33(b)), as in effect on September 30, 1998, shall be applied as if the amendments made by this section had not been enacted." EFFECTIVE DATE OF 1992 AMENDMENTS Amendment by Pub. L. 102−352 effective immediately upon effectuation of amendment made by Pub. L. 102−321, see section 3(1) of Pub. L. 102−352, set out as a note under section 285n of this title.

118

−SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in sections 300x, 300x−1, 300x−33, 300x−64 of this title. −End− −CITE− 42 USC Sec. 300x−8 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XVII − BLOCK GRANTS Part B − Block Grants Regarding Mental Health and Substance Abuse subpart i − block grants for community mental health services −HEAD− Sec. 300x−8. Definitions −STATUTE− For purposes of this subpart: (1) The terms "adults with a serious mental illness" and "children with a serious emotional disturbance" have the meanings given such terms under section 300x−1(c)(1) of this title. (2) The term "funding agreement", with respect to a grant under section 300x of this title to a State, means that the Secretary may make such a grant only if the State makes the agreement involved. −SOURCE− (July 1, 1944, ch. 373, title XIX, Sec. 1919, as added Pub. L.

119

102−321, title II, Sec. 201(2), July 10, 1992, 106 Stat. 388.) −MISC1− PRIOR PROVISIONS A prior section 300x−8, act July 1, 1944, ch. 373, title XIX, Sec. 1920, formerly Sec. 1919, as added Aug. 13, 1981, Pub. L. 97−35, title IX, Sec. 901, 95 Stat. 552; renumbered Sec. 1920, Oct. 19, 1984, Pub. L. 98−509, title I, Sec. 106(g), 98 Stat. 2359, authorized criminal penalty for false statements in connection with services furnished relative to alcohol, drug abuse, and mental health services block grant, prior to repeal by Pub. L. 102−321, Sec. 201(2). A prior section 1919 of act July 1, 1944, was classified to section 300x−7 of this title prior to repeal by Pub. L. 102−321. −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in section 300x−64 of this title. −End− −CITE− 42 USC Sec. 300x−9 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XVII − BLOCK GRANTS Part B − Block Grants Regarding Mental Health and Substance Abuse subpart i − block grants for community mental health services −HEAD−

120

Sec. 300x−9. Funding −STATUTE− (a) Authorization of appropriations For the purpose of carrying out this subpart, and subpart III and section 290aa−4 of this title with respect to mental health, there are authorized to be appropriated $450,000,000 for fiscal year 2001, and such sums as may be necessary for each of the fiscal years 2002 and 2003. (b) Allocations for technical assistance, data collection, and program evaluation (1) In general For the purpose of carrying out section 300x−58(a) of this title with respect to mental health and the purposes specified in paragraphs (2) and (3), the Secretary shall obligate 5 percent of the amounts appropriated under subsection (a) of this section for a fiscal year. (2) Data collection The purpose specified in this paragraph is carrying out sections 290aa−4 and 300y of this title with respect to mental health. (3) Program evaluation The purpose specified in this paragraph is the conduct of evaluations of prevention and treatment programs and services with respect to mental health to determine methods for improving the availability and quality of such programs and services. −SOURCE−

121

(July 1, 1944, ch. 373, title XIX, Sec. 1920, as added Pub. L. 102−321, title II, Sec. 201(2), July 10, 1992, 106 Stat. 388; amended Pub. L. 106−310, div. B, title XXXII, Sec. 3204(f), Oct. 17, 2000, 114 Stat. 1193.) −MISC1− PRIOR PROVISIONS Prior sections 300x−9 to 300x−13 were repealed by Pub. L. 102−321, title II, Sec. 201(2), July 10, 1992, 106 Stat. 378. Section 300x−9, act July 1, 1944, ch. 373, title XIX, Sec. 1921, formerly Sec. 1920, as added Aug. 13, 1981, Pub. L. 97−35, title IX, Sec. 901, 95 Stat. 552; renumbered Sec. 1920A and amended Oct. 19, 1984, Pub. L. 98−509, title I, Secs. 105(a), 106(g), 98 Stat. 2358, 2359; Oct. 7, 1985, Pub. L. 99−117, Sec. 7(c), 99 Stat. 493; renumbered Sec. 1921 and amended Nov. 18, 1988, Pub. L. 100−690, title II, Sec. 2038(2), (6), 102 Stat. 4203, authorized technical assistance with respect to development of services under alcohol, drug abuse, and mental health services block grants. A prior section 1920 of act July 1, 1944, was classified to section 300x−8 of this title and repealed by Pub. L. 102−321. Section 300x−9a, act July 1, 1944, ch. 373, title XIX, Sec. 1922, as added Nov. 18, 1988, Pub. L. 100−690, title II, Sec. 2039(a), 102 Stat. 4204; amended Aug. 16, 1989, Pub. L. 101−93, Sec. 2(n)(1), 103 Stat. 608, related to service research on community−based alcohol and drug abuse treatment programs. Section 300x−9b, act July 1, 1944, ch. 373, title XIX, Sec. 1923, as added Nov. 18, 1988, Pub. L. 100−690, title II, Sec. 2040, 102

122

Stat. 4204; amended Aug. 16, 1989, Pub. L. 101−93, Sec. 2(q)(2), 103 Stat. 609, related to service research on community−based mental health treatment programs. Section 300x−10, act July 1, 1944, ch. 373, title XIX, Sec. 1924, formerly Sec. 1920B, as added Nov. 14, 1986, Pub. L. 99−660, title V, Sec. 502(2), 100 Stat. 3795; renumbered Sec. 1924 and amended Nov. 18, 1988, Pub. L. 100−690, title II, Sec. 2038(3), (4), 102 Stat. 4203; Nov. 28, 1990, Pub. L. 101−639, Sec. 3(a)(1), 104 Stat. 4601, related to development grants for State comprehensive mental health services plans. Section 300x−11, act July 1, 1944, ch. 373, title XIX, Sec. 1925, formerly Sec. 1920C, as added Nov. 14, 1986, Pub. L. 99−660, title V, Sec. 502(2), 100 Stat. 3795; renumbered Sec. 1925 and amended Nov. 18, 1988, Pub. L. 100−690, title II, Secs. 2038(3), 2041(a), 102 Stat. 4203, 4205; Aug. 16, 1989, Pub. L. 101−93, Sec. 2(o)(1), 103 Stat. 608; Nov. 28, 1990, Pub. L. 101−639, Sec. 3(b), 104 Stat. 4601, related to State comprehensive mental health services plans. Section 300x−12, act July 1, 1944, ch. 373, title XIX, Sec. 1926, formerly Sec. 1920D, as added Nov. 14, 1986, Pub. L. 99−660, title V, Sec. 502(2), 100 Stat. 3796; renumbered Sec. 1926 and amended Nov. 18, 1988, Pub. L. 100−690, title II, Sec. 2038(3), (5), 102 Stat. 4203; Aug. 16, 1989, Pub. L. 101−93, Sec. 2(o)(2), 103 Stat. 609; Nov. 28, 1990, Pub. L. 101−639, Sec. 3(c), 104 Stat. 4602, related to enforcement of requirement of developing State comprehensive mental health services plans. Section 300x−13, act July 1, 1944, ch. 373, title XIX, Sec. 1927,

123

formerly Sec. 1920E, as added Nov. 14, 1986, Pub. L. 99−660, title V, Sec. 502(2), 100 Stat. 3797; renumbered Sec. 1927, Nov. 18, 1988, Pub. L. 100−690, title II, Sec. 2038(3), 102 Stat. 4203, related to development of model standards for provision of care to chronically mentally ill persons. AMENDMENTS 2000 − Subsec. (a). Pub. L. 106−310, Sec. 3204(f)(1), substituted "$450,000,000 for fiscal year 2001, and such sums as may be necessary for each of the fiscal years 2002 and 2003" for "$450,000,000 for fiscal year 1993, and such sums as may be necessary for fiscal year 1994". Subsec. (b)(2). Pub. L. 106−310, Sec. 3204(f)(2), substituted "sections 290aa−4 and 300y of this title" for "section 290aa−4 of this title". −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in section 300x−7 of this title. −End− −CITE− 42 USC subpart ii − block grants for prevention and treatment of substance abuse 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XVII − BLOCK GRANTS Part B − Block Grants Regarding Mental Health and Substance Abuse

124

subpart ii − block grants for prevention and treatment of substance abuse −HEAD− SUBPART II − BLOCK GRANTS FOR PREVENTION AND TREATMENT OF SUBSTANCE ABUSE −SECREF− SUBPART REFERRED TO IN OTHER SECTIONS This subpart is referred to in sections 290kk, 300x−59, 422, 1383e of this title. −End− −CITE− 42 USC Sec. 300x−21 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XVII − BLOCK GRANTS Part B − Block Grants Regarding Mental Health and Substance Abuse subpart ii − block grants for prevention and treatment of substance abuse −HEAD− Sec. 300x−21. Formula grants to States −STATUTE− (a) In general For the purpose described in subsection (b) of this section, the Secretary, acting through the Center for Substance Abuse Treatment, shall make an allotment each fiscal year for each State in an

125

amount determined in accordance with section 300x−33 of this title. The Secretary shall make a grant to the State of the allotment made for the State for the fiscal year if the State submits to the Secretary an application in accordance with section 300x−32 of this title. (b) Authorized activities A funding agreement for a grant under subsection (a) of this section is that, subject to section 300x−31 of this title, the State involved will expend the grant only for the purpose of planning, carrying out, and evaluating activities to prevent and treat substance abuse and for related activities authorized in section 300x−24 of this title. −SOURCE− (July 1, 1944, ch. 373, title XIX, Sec. 1921, as added Pub. L. 102−321, title II, Sec. 202, July 10, 1992, 106 Stat. 388.) −MISC1− PRIOR PROVISIONS A prior section 1921 of act July 1, 1944, was classified to section 300x−9 of this title prior to repeal by Pub. L. 102−321. Another prior section 1921 of act July 1, 1944, was classified to section 300y of this title prior to repeal by Pub. L. 100−690. −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in sections 290aa−2a, 290bb, 300x−22, 300x−23, 300x−24, 300x−25, 300x−26, 300x−27, 300x−28, 300x−29, 300x−30, 300x−31, 300x−32, 300x−33, 300x−34, 300x−51, 300x−52,

126

300x−53, 300x−54, 300x−55, 300x−56, 300x−57, 300x−58, 300x−60, 300x−62, 300x−63, 300x−64, 300x−66, 1395x of this title. −End− −CITE− 42 USC Sec. 300x−22 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XVII − BLOCK GRANTS Part B − Block Grants Regarding Mental Health and Substance Abuse subpart ii − block grants for prevention and treatment of substance abuse −HEAD− Sec. 300x−22. Certain allocations −STATUTE− (a) Allocation regarding primary prevention programs A funding agreement for a grant under section 300x−21 of this title is that, in expending the grant, the State involved − (1) will expend not less than 20 percent for programs for individuals who do not require treatment for substance abuse, which programs − (A) educate and counsel the individuals on such abuse; and (B) provide for activities to reduce the risk of such abuse by the individuals; (2) will, in carrying out paragraph (1) − (A) give priority to programs for populations that are at

127

risk of developing a pattern of such abuse; and (B) ensure that programs receiving priority under subparagraph (A) develop community−based strategies for the prevention of such abuse, including strategies to discourage the use of alcoholic beverages and tobacco products by individuals to whom it is unlawful to sell or distribute such beverages or products. (b) Allocations regarding women (1) In general Subject to paragraph (2), a funding agreement for a grant under section 300x−21 of this title for a fiscal year is that − (A) in the case of a grant for fiscal year 1993, the State involved will expend not less than 5 percent of the grant to increase (relative to fiscal year 1992) the availability of treatment services designed for pregnant women and women with dependent children (either by establishing new programs or expanding the capacity of existing programs); (B) in the case of a grant for fiscal year 1994, the State will expend not less than 5 percent of the grant to so increase (relative to fiscal year 1993) the availability of such services for such women; and (C) in the case of a grant for any subsequent fiscal year, the State will expend for such services for such women not less than an amount equal to the amount expended by the State for fiscal year 1994. (2) Waiver

128

(A) Upon the request of a State, the Secretary may provide to the State a waiver of all or part of the requirement established in paragraph (1) if the Secretary determines that the State is providing an adequate level of treatments services for women described in such paragraph, as indicated by a comparison of the number of such women seeking the services with the availability in the State of the services. (B) The Secretary shall approve or deny a request for a waiver under subparagraph (A) not later than 120 days after the date on which the request is made. (C) Any waiver provided by the Secretary under subparagraph (A) shall be applicable only to the fiscal year involved. (3) Childcare and prenatal care A funding agreement for a grant under section 300x−21 of this title for a State is that each entity providing treatment services with amounts reserved under paragraph (1) by the State will, directly or through arrangements with other public or nonprofit private entities, make available prenatal care to women receiving such services and, while the women are receiving the services, childcare. −SOURCE− (July 1, 1944, ch. 373, title XIX, Sec. 1922, as added Pub. L. 102−321, title II, Sec. 202, July 10, 1992, 106 Stat. 389; amended Pub. L. 106−310, div. B, title XXXIII, Sec. 3303(a), (f)(2)(A), Oct. 17, 2000, 114 Stat. 1210, 1211.) −STATAMEND−

129

AMENDMENT OF SUBSECTION (B)(2), (3) Pub. L. 106−310, div. B, title XXXIII, Sec. 3303(f)(2), Oct. 17, 2000, 114 Stat. 1211, provided that, effective upon publication of regulations developed in accordance with section 300x−32(e)(1) of this title, subsection (c) of this section [now subsection (b)] is amended by striking out paragraph (2) and redesignating paragraph (3) as paragraph (2). −MISC1− PRIOR PROVISIONS A prior section 1922 of act July 1, 1944, was classified to section 300x−9a of this title prior to repeal by Pub. L. 102−321. Another prior section 1922 of act July 1, 1944, was classified to section 300y−1 of this title prior to repeal by Pub. L. 100−690. AMENDMENTS 2000 − Subsec. (a). Pub. L. 106−310, Sec. 3303(a), redesignated subsec. (b) as (a) and struck out heading and text of former subsec. (a). Text read as follows: "A funding agreement for a grant under section 300x−21 of this title is that, in expending the grant, the State involved will expend − "(1) not less than 35 percent for prevention and treatment activities regarding alcohol; and "(2) not less than 35 percent for prevention and treatment activities regarding other drugs." Subsec. (b). Pub. L. 106−310, Sec. 3303(a)(2), redesignated subsec. (c) as (b). Former subsec. (b) redesignated (a). Subsec. (c). Pub. L. 106−310, Sec. 3303(a)(2), redesignated

130

subsec. (c) as (b). EFFECTIVE DATE OF 2000 AMENDMENT Pub. L. 106−310, div. B, title XXXIII, Sec. 3303(f)(2), Oct. 17, 2000, 114 Stat. 1211, provided that the amendment made by section 3303(f)(2) is effective upon the publication of the regulations developed in accordance with section 300x−32(e)(1) of this title. −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in section 300x−32 of this title. −End− −CITE− 42 USC Sec. 300x−23 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XVII − BLOCK GRANTS Part B − Block Grants Regarding Mental Health and Substance Abuse subpart ii − block grants for prevention and treatment of substance abuse −HEAD− Sec. 300x−23. Intravenous substance abuse −STATUTE− (a) Capacity of treatment programs (1) Notification of reaching capacity A funding agreement for a grant under section 300x−21 of this title is that the State involved will, in the case of programs of

131

treatment for intravenous drug abuse, require that any such program receiving amounts from the grant, upon reaching 90 percent of its capacity to admit individuals to the program, provide to the State a notification of such fact. (2) Provision of treatment A funding agreement for a grant under section 300x−21 of this title is that the State involved will, with respect to notifications under paragraph (1), ensure that each individual who requests and is in need of treatment for intravenous drug abuse is admitted to a program of such treatment not later than − (A) 14 days after making the request for admission to such a program; or (B) 120 days after the date of such request, if no such program has the capacity to admit the individual on the date of such request and if interim services are made available to the individual not later than 48 hours after such request. (b) Outreach regarding intravenous substance abuse A funding agreement for a grant under section 300x−21 of this title is that the State involved, in providing amounts from the grant to any entity for treatment services for intravenous drug abuse, will require the entity to carry out activities to encourage individuals in need of such treatment to undergo treatment. −SOURCE− (July 1, 1944, ch. 373, title XIX, Sec. 1923, as added Pub. L. 102−321, title II, Sec. 202, July 10, 1992, 106 Stat. 390.) −MISC1−

132

PRIOR PROVISIONS A prior section 1923 of act July 1, 1944, was classified to section 300x−9b of this title prior to repeal by Pub. L. 102−321. Another prior section 1923 of act July 1, 1944, was classified to section 300y−2 of this title prior to repeal by Pub. L. 100−690. −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in sections 300x−29, 300x−32 of this title. −End− −CITE− 42 USC Sec. 300x−24 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XVII − BLOCK GRANTS Part B − Block Grants Regarding Mental Health and Substance Abuse subpart ii − block grants for prevention and treatment of substance abuse −HEAD− Sec. 300x−24. Requirements regarding tuberculosis and human immunodeficiency virus −STATUTE− (a) Tuberculosis (1) In general A funding agreement for a grant under section 300x−21 of this

133

title is that the State involved will require that any entity receiving amounts from the grant for operating a program of treatment for substance abuse − (A) will, directly or through arrangements with other public or nonprofit private entities, routinely make available tuberculosis services to each individual receiving treatment for such abuse; and (B) in the case of an individual in need of such treatment who is denied admission to the program on the basis of the lack of the capacity of the program to admit the individual, will refer the individual to another provider of tuberculosis services. (2) Tuberculosis services For purposes of paragraph (1), the term "tuberculosis services", with respect to an individual, means − (A) counseling the individual with respect to tuberculosis; (B) testing to determine whether the individual has contracted such disease and testing to determine the form of treatment for the disease that is appropriate for the individual; and (C) providing such treatment to the individual. (b) Human immunodeficiency virus (1) Requirement for certain States In the case of a State described in paragraph (2), a funding agreement for a grant under section 300x−21 of this title is that −

134

(A) with respect to individuals undergoing treatment for substance abuse, the State will, subject to paragraph (3), carry out 1 or more projects to make available to the individuals early intervention services for HIV disease at the sites at which the individuals are undergoing such treatment; (B) for the purpose of providing such early intervention services through such projects, the State will make available from the grant the percentage that is applicable for the State under paragraph (4); and (C) the State will, subject to paragraph (5), carry out such projects only in geographic areas of the State that have the greatest need for the projects. (2) Designated States For purposes of this subsection, a State described in this paragraph is any State whose rate of cases of acquired immune deficiency syndrome is 10 or more such cases per 100,000 individuals (as indicated by the number of such cases reported to and confirmed by the Director of the Centers for Disease Control for the most recent calendar year for which such data are available). (3) Use of existing programs regarding substance abuse With respect to programs that provide treatment services for substance abuse, a funding agreement for a grant under section 300x−21 of this title for a designated State is that each such program participating in a project under paragraph (1) will be a program that began operation prior to the fiscal year for which

135

the State is applying to receive the grant. A program that so began operation may participate in a project under paragraph (1) without regard to whether the program has been providing early intervention services for HIV disease. (4) Applicable percentage regarding expenditures for services (A)(i) For purposes of paragraph (1)(B), the percentage that is applicable under this paragraph for a designated State is, subject to subparagraph (B), the percentage by which the amount of the grant under section 300x−21 of this title for the State for the fiscal year involved is an increase over the amount specified in clause (ii). (ii) The amount specified in this clause is the amount that was reserved by the designated State involved from the allotment of the State under section 300x−1a (!1) of this title for fiscal year 1991 in compliance with section 300x−4(c)(6)(A)(ii) (!1) of this title (as such sections were in effect for such fiscal year). (B) If the percentage determined under subparagraph (A) for a designated State for a fiscal year is less than 2 percent (including a negative percentage, in the case of a State for which there is no increase for purposes of such subparagraph), the percentage applicable under this paragraph for the State is 2 percent. If the percentage so determined is 2 percent or more, the percentage applicable under this paragraph for the State is the percentage determined under subparagraph (A), subject to not exceeding 5 percent.

136

(5) Requirement regarding rural areas (A) A funding agreement for a grant under section 300x−21 of this title for a designated State is that, if the State will carry out 2 or more projects under paragraph (1), the State will carry out 1 such project in a rural area of the State, subject to subparagraph (B). (B) The Secretary shall waive the requirement established in subparagraph (A) if the State involved certifies to the Secretary that − (i) there is insufficient demand in the State to carry out a project under paragraph (1) in any rural area of the State; or (ii) there are no rural areas in the State. (6) Manner of providing services With respect to the provision of early intervention services for HIV disease to an individual, a funding agreement for a grant under section 300x−21 of this title for a designated State is that − (A) such services will be undertaken voluntarily by, and with the informed consent of, the individual; and (B) undergoing such services will not be required as a condition of receiving treatment services for substance abuse or any other services. (7) Definitions For purposes of this subsection: (A) The term "designated State" means a State described in paragraph (2).

137

(B) The term "early intervention services", with respect to HIV disease, means − (i) appropriate pretest counseling; (ii) testing individuals with respect to such disease, including tests to confirm the presence of the disease, tests to diagnose the extent of the deficiency in the immune system, and tests to provide information on appropriate therapeutic measures for preventing and treating the deterioration of the immune system and for preventing and treating conditions arising from the disease; (iii) appropriate post−test counseling; and (iv) providing the therapeutic measures described in clause (ii). (C) The term "HIV disease" means infection with the etiologic agent for acquired immune deficiency syndrome. (c) Expenditure of grant for compliance with agreements (1) In general A grant under section 300x−21 of this title may be expended for purposes of compliance with the agreements required in this section, subject to paragraph (2). (2) Limitation A funding agreement for a grant under section 300x−21 of this title for a State is that the grant will not be expended to make payment for any service provided for purposes of compliance with this section to the extent that payment has been made, or can reasonably be expected to be made, with respect to such service −

138

(A) under any State compensation program, under any insurance policy, or under any Federal or State health benefits program (including the program established in title XVIII of the Social Security Act [42 U.S.C. 1395 et seq.] and the program established in title XIX of such Act [42 U.S.C. 1396 et seq.]); or (B) by an entity that provides health services on a prepaid basis. (d) Maintenance of effort With respect to services provided for by a State for purposes of compliance with this section, a funding agreement for a grant under section 300x−21 of this title is that the State will maintain expenditures of non−Federal amounts for such services at a level that is not less than average level of such expenditures maintained by the State for 2−year period preceding the first fiscal year for which the State receives such a grant. (e) Applicability of certain provision Section 300x−31 of this title applies to this section (and to each other provision of this subpart). −SOURCE− (July 1, 1944, ch. 373, title XIX, Sec. 1924, as added Pub. L. 102−321, title II, Sec. 202, July 10, 1992, 106 Stat. 391.) −REFTEXT− REFERENCES IN TEXT Section 300x−1a of this title, referred to in subsec. (b)(4)(A)(ii), was repealed by Pub. L. 102−321, title II, Sec.

139

201(2), July 10, 1992, 106 Stat. 378. Section 300x−4 of this title, referred to in subsec. (b)(4)(A)(ii), was in the original a reference to section 1916 of act July 1, 1944, which was repealed by Pub. L. 102−321, title II, Sec. 201(2), July 10, 1992, 106 Stat. 378. Section 201(2) of Pub. L. 102−321 enacted new sections 1915 and 1916 of act July 1, 1944, which are classified to sections 300x−4 and 300x−5, respectively, of this title. The Social Security Act, referred to in subsec. (c)(2)(A), is act Aug. 14, 1935, ch. 531, 49 Stat. 620, as amended. Titles XVIII and XIX of the Act are classified generally to subchapters XVIII (Sec. 1395 et seq.) and XIX (Sec. 1396 et seq.) of chapter 7 of this title. For complete classification of this Act to the Code, see section 1305 of this title and Tables. −MISC1− PRIOR PROVISIONS A prior section 1924 of act July 1, 1944, was classified to section 300x−10 of this title prior to repeal by Pub. L. 102−321. Another prior section 1924 of act July 1, 1944, was classified to section 300y−3 of this title prior to repeal by Pub. L. 99−280. −CHANGE− CHANGE OF NAME Centers for Disease Control changed to Centers for Disease Control and Prevention by Pub. L. 102−531, title III, Sec. 312, Oct. 27, 1992, 106 Stat. 3504. −SECREF−

140

SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in sections 300x−21, 300x−32 of this title. −FOOTNOTE− (!1) See References in Text note below. −End− −CITE− 42 USC Sec. 300x−25 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XVII − BLOCK GRANTS Part B − Block Grants Regarding Mental Health and Substance Abuse subpart ii − block grants for prevention and treatment of substance abuse −HEAD− Sec. 300x−25. Group homes for recovering substance abusers −STATUTE− (a) State revolving funds for establishment of homes A State, using funds available under section 300x−21 of this title, may establish and maintain the ongoing operation of a revolving fund in accordance with this section to support group homes for recovering substance abusers as follows: (1) The purpose of the fund is to make loans for the costs of establishing programs for the provision of housing in which individuals recovering from alcohol or drug abuse may reside in

141

groups of not less than 6 individuals. The fund is established directly by the State or through the provision of a grant or contract to a nonprofit private entity. (2) The programs are carried out in accordance with guidelines issued under subsection (b) of this section. (3) Not less than $100,000 is available for the fund. (4) Loans made from the revolving fund do not exceed $4,000 and each such loan is repaid to the revolving fund by the residents of the housing involved not later than 2 years after the date on which the loan is made. (5) Each such loan is repaid by such residents through monthly installments, and a reasonable penalty is assessed for each failure to pay such periodic installments by the date specified in the loan agreement involved. (6) Such loans are made only to nonprofit private entities agreeing that, in the operation of the program established pursuant to the loan − (A) the use of alcohol or any illegal drug in the housing provided by the program will be prohibited; (B) any resident of the housing who violates such prohibition will be expelled from the housing; (C) the costs of the housing, including fees for rent and utilities, will be paid by the residents of the housing; and (D) the residents of the housing will, through a majority vote of the residents, otherwise establish policies governing residence in the housing, including the manner in which

142

applications for residence in the housing are approved. (b) Issuance by Secretary of guidelines The Secretary shall ensure that there are in effect guidelines under this subpart for the operation of programs described in subsection (a) of this section. (c) Applicability to territories The requirements established in subsection (a) of this section shall not apply to any territory of the United States other than the Commonwealth of Puerto Rico. −SOURCE− (July 1, 1944, ch. 373, title XIX, Sec. 1925, as added Pub. L. 102−321, title II, Sec. 202, July 10, 1992, 106 Stat. 393; amended Pub. L. 106−310, div. B, title XXXIII, Sec. 3303(b), Oct. 17, 2000, 114 Stat. 1210.) −MISC1− PRIOR PROVISIONS A prior section 1925 of act July 1, 1944, was classified to section 300x−11 of this title prior to repeal by Pub. L. 102−321. Another prior section 1925 of act July 1, 1944, was classified to section 300y−4 of this title prior to repeal by Pub. L. 99−280. AMENDMENTS 2000 − Subsec. (a). Pub. L. 106−310, in introductory provisions, substituted "A State, using funds available under section 300x−21 of this title, may establish and maintain the ongoing operation of a revolving fund in accordance with this section to support group homes for recovering substance abusers as follows:" for "For fiscal

143

year 1993 and subsequent fiscal years, the Secretary may make a grant under section 300x−21 of this title only if the State involved has established, and is providing for the ongoing operation of, a revolving fund as follows:". −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in section 290bb of this title. −End− −CITE− 42 USC Sec. 300x−26 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XVII − BLOCK GRANTS Part B − Block Grants Regarding Mental Health and Substance Abuse subpart ii − block grants for prevention and treatment of substance abuse −HEAD− Sec. 300x−26. State law regarding sale of tobacco products to individuals under age of 18 −STATUTE− (a) Relevant law (1) In general Subject to paragraph (2), for fiscal year 1994 and subsequent fiscal years, the Secretary may make a grant under section 300x−21 of this title only if the State involved has in effect a

144

law providing that it is unlawful for any manufacturer, retailer, or distributor of tobacco products to sell or distribute any such product to any individual under the age of 18. (2) Delayed applicability for certain States In the case of a State whose legislature does not convene a regular session in fiscal year 1993, and in the case of a State whose legislature does not convene a regular session in fiscal year 1994, the requirement described in paragraph (1) as a condition of a receipt of a grant under section 300x−21 of this title shall apply only for fiscal year 1995 and subsequent fiscal years. (b) Enforcement (1) In general For the first applicable fiscal year and for subsequent fiscal years, a funding agreement for a grant under section 300x−21 of this title is that the State involved will enforce the law described in subsection (a) of this section in a manner that can reasonably be expected to reduce the extent to which tobacco products are available to individuals under the age of 18. (2) Activities and reports regarding enforcement For the first applicable fiscal year and for subsequent fiscal years, a funding agreement for a grant under section 300x−21 of this title is that the State involved will − (A) annually conduct random, unannounced inspections to ensure compliance with the law described in subsection (a) of this section; and

145

(B) annually submit to the Secretary a report describing − (i) the activities carried out by the State to enforce such law during the fiscal year preceding the fiscal year for which the State is seeking the grant; (ii) the extent of success the State has achieved in reducing the availability of tobacco products to individuals under the age of 18; and (iii) the strategies to be utilized by the State for enforcing such law during the fiscal year for which the grant is sought. (c) Noncompliance of State Before making a grant under section 300x−21 of this title to a State for the first applicable fiscal year or any subsequent fiscal year, the Secretary shall make a determination of whether the State has maintained compliance with subsections (a) and (b) of this section. If, after notice to the State and an opportunity for a hearing, the Secretary determines that the State is not in compliance with such subsections, the Secretary shall reduce the amount of the allotment under such section for the State for the fiscal year involved by an amount equal to − (1) in the case of the first applicable fiscal year, 10 percent of the amount determined under section 300x−33 of this title for the State for the fiscal year; (2) in the case of the first fiscal year following such applicable fiscal year, 20 percent of the amount determined under section 300x−33 of this title for the State for the fiscal year;

146

(3) in the case of the second such fiscal year, 30 percent of the amount determined under section 300x−33 of this title for the State for the fiscal year; and (4) in the case of the third such fiscal year or any subsequent fiscal year, 40 percent of the amount determined under section 300x−33 of this title for the State for the fiscal year. (d) "First applicable fiscal year" defined For purposes of this section, the term "first applicable fiscal year" means − (1) fiscal year 1995, in the case of any State described in subsection (a)(2) of this section; and (2) fiscal year 1994, in the case of any other State. −SOURCE− (July 1, 1944, ch. 373, title XIX, Sec. 1926, as added Pub. L. 102−321, title II, Sec. 202, July 10, 1992, 106 Stat. 394.) −MISC1− PRIOR PROVISIONS A prior section 1926 of act July 1, 1944, was classified to section 300x−12 of this title prior to repeal by Pub. L. 102−321. Another prior section 1926 of act July 1, 1944, was classified to section 300y−5 of this title prior to repeal by Pub. L. 99−280. −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in sections 300x−54, 300x−55 of this title. −End−

147

−CITE− 42 USC Sec. 300x−27 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XVII − BLOCK GRANTS Part B − Block Grants Regarding Mental Health and Substance Abuse subpart ii − block grants for prevention and treatment of substance abuse −HEAD− Sec. 300x−27. Treatment services for pregnant women −STATUTE− (a) In general A funding agreement for a grant under section 300x−21 of this title is that the State involved − (1) will ensure that each pregnant woman in the State who seeks or is referred for and would benefit from such services is given preference in admissions to treatment facilities receiving funds pursuant to the grant; and (2) will, in carrying out paragraph (1), publicize the availability to such women of services from the facilities and the fact that the women receive such preference. (b) Referrals regarding States A funding agreement for a grant under section 300x−21 of this title is that, in carrying out subsection (a)(1) of this section − (1) the State involved will require that, in the event that a

148

treatment facility has insufficient capacity to provide treatment services to any woman described in such subsection who seeks the services from the facility, the facility refer the woman to the State; and (2) the State, in the case of each woman for whom a referral under paragraph (1) is made to the State − (A) will refer the woman to a treatment facility that has the capacity to provide treatment services to the woman; or (B) will, if no treatment facility has the capacity to admit the woman, make interim services available to the woman not later than 48 hours after the women (!1) seeks the treatment services. −SOURCE− (July 1, 1944, ch. 373, title XIX, Sec. 1927, as added Pub. L. 102−321, title II, Sec. 202, July 10, 1992, 106 Stat. 395; amended Pub. L. 102−352, Sec. 2(a)(10), Aug. 26, 1992, 106 Stat. 938.) −MISC1− PRIOR PROVISIONS A prior section 1927 of act July 1, 1944, was classified to section 300x−12 of this title prior to repeal by Pub. L. 102−321. Another prior section 1927 of act July 1, 1944, was classified to section 300y−6 of this title prior to repeal by Pub. L. 99−280. AMENDMENTS 1992 − Subsec. (b)(2)(B). Pub. L. 102−352 struck out "available" before "interim services available". EFFECTIVE DATE OF 1992 AMENDMENT

149

Amendment by Pub. L. 102−352 effective immediately upon effectuation of amendment made by Pub. L. 102−321, see section 3(1) of Pub. L. 102−352, set out as a note under section 285n of this title. −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in section 300x−29 of this title. −FOOTNOTE− (!1) So in original. Probably should be "woman". −End− −CITE− 42 USC Sec. 300x−28 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XVII − BLOCK GRANTS Part B − Block Grants Regarding Mental Health and Substance Abuse subpart ii − block grants for prevention and treatment of substance abuse −HEAD− Sec. 300x−28. Additional agreements −STATUTE− (a) Improvement of process for appropriate referrals for treatment With respect to individuals seeking treatment services, a funding agreement for a grant under section 300x−21 of this title is that the State involved will improve (relative to fiscal year 1992) the

150

process in the State for referring the individuals to treatment facilities that can provide to the individuals the treatment modality that is most appropriate for the individuals. (b) Continuing education With respect to any facility for treatment services or prevention actitivities (!1) that is receiving amounts from a grant under section 300x−21 of this title, a funding agreement for a State for a grant under such section is that continuing education in such services or activities (or both, as the case may be) will be made available to employees of the facility who provide the services or activities. (c) Coordination of various activities and services A funding agreement for a grant under section 300x−21 of this title is that the State involved will coordinate prevention and treatment activities with the provision of other appropriate services (including health, social, correctional and criminal justice, educational, vocational rehabilitation, and employment services). (d) Waiver of requirement (1) In general Upon the request of a State, the Secretary may provide to a State a waiver of any or all of the requirements established in this section if the Secretary determines that, with respect to services for the prevention and treatment of substance abuse, the requirement involved is unnecessary for maintaining quality in the provision of such services in the State.

151

(2) Date certain for acting upon request The Secretary shall approve or deny a request for a waiver under paragraph (1) not later than 120 days after the date on which the request is made. (3) Applicability of waiver Any waiver provided by the Secretary under paragraph (1) shall be applicable only to the fiscal year involved. −SOURCE− (July 1, 1944, ch. 373, title XIX, Sec. 1928, as added Pub. L. 102−321, title II, Sec. 202, July 10, 1992, 106 Stat. 396; amended Pub. L. 106−310, div. B, title XXXIII, Sec. 3303(f)(2)(B), Oct. 17, 2000, 114 Stat. 1211.) −STATAMEND− REPEAL OF SUBSECTION (D) Pub. L. 106−310, div. B, title XXXIII, Sec. 3303(f)(2), Oct. 17, 2000, 114 Stat. 1211, provided that, effective upon publication of regulations developed in accordance with section 300x−32(e)(1) of this title, subsection (d) of this section is repealed. −MISC1− PRIOR PROVISIONS A prior section 1928 of act July 1, 1944, was classified to section 300y−7 of this title prior to repeal by Pub. L. 99−280. EFFECTIVE DATE OF 2000 AMENDMENT Pub. L. 106−310, div. B, title XXXIII, Sec. 3303(f)(2), Oct. 17, 2000, 114 Stat. 1211, provided that the amendment made by section 3303(f)(2) is effective upon the publication of the regulations

152

developed in accordance with section 300x−32(e)(1) of this title. −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in section 300x−32 of this title. −FOOTNOTE− (!1) So in original. Probably should be "activities". −End− −CITE− 42 USC Sec. 300x−29 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XVII − BLOCK GRANTS Part B − Block Grants Regarding Mental Health and Substance Abuse subpart ii − block grants for prevention and treatment of substance abuse −HEAD− Sec. 300x−29. Submission to Secretary of statewide assessment of needs −STATUTE− The Secretary may make a grant under section 300x−21 of this title only if the State submits to the Secretary an assessment of the need in the State for authorized activities (which assessment is conducted in accordance with criteria issued by the Secretary), both by locality and by the State in general, which assessment includes a description of −

153

(1) the incidence and prevalence in the State of drug abuse and the incidence and prevalence in the State of alcohol abuse and alcoholism; (2) current prevention and treatment activities in the State; (3) the need of the State for technical assistance to carry out such activities; (4) efforts by the State to improve such activities; and (5) the extent to which the availability of such activities is insufficient to meet the need for the activities, the interim services to be made available under sections 300x−23(a) and 300x−27(b) of this title, and the manner in which such services are to be so available. −SOURCE− (July 1, 1944, ch. 373, title XIX, Sec. 1929, as added Pub. L. 102−321, title II, Sec. 202, July 10, 1992, 106 Stat. 396.) −MISC1− PRIOR PROVISIONS A prior section 1929 of act July 1, 1944, was classified to section 300y−8 of this title prior to repeal by Pub. L. 99−280. −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in section 300x−32 of this title. −End− −CITE− 42 USC Sec. 300x−30 01/06/03 −EXPCITE−

154

TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XVII − BLOCK GRANTS Part B − Block Grants Regarding Mental Health and Substance Abuse subpart ii − block grants for prevention and treatment of substance abuse −HEAD− Sec. 300x−30. Maintenance of effort regarding State expenditures −STATUTE− (a) In general With respect to the principal agency of a State for carrying out authorized activities, a funding agreement for a grant under section 300x−21 of this title for the State for a fiscal year is that such agency will for such year maintain aggregate State expenditures for authorized activities at a level that is not less than the average level of such expenditures maintained by the State for the 2−year period preceding the fiscal year for which the State is applying for the grant. (b) Exclusion of certain funds The Secretary may exclude from the aggregate State expenditures under subsection (a) of this section, funds appropriated to the principle agency for authorized activities which are of a non−recurring nature and for a specific purpose. (c) Waiver (1) In general Upon the request of a State, the Secretary may waive all or

155

part of the requirement established in subsection (a) of this section if the Secretary determines that extraordinary economic conditions in the State justify the waiver. (2) Date certain for acting upon request The Secretary shall approve or deny a request for a waiver under paragraph (1) not later than 120 days after the date on which the request is made. (3) Applicability of waiver Any waiver provided by the Secretary under paragraph (1) shall be applicable only to the fiscal year involved. (d) Noncompliance by State (1) In general In making a grant under section 300x−21 of this title to a State for a fiscal year, the Secretary shall make a determination of whether, for the previous fiscal year, the State maintained material compliance with any agreement made under subsection (a) of this section. If the Secretary determines that a State has failed to maintain such compliance, the Secretary shall reduce the amount of the allotment under section 300x−21 of this title for the State for the fiscal year for which the grant is being made by an amount equal to the amount constituting such failure for the previous fiscal year. (2) Submission of information to Secretary The Secretary may make a grant under section 300x−21 of this title for a fiscal year only if the State involved submits to the Secretary information sufficient for the Secretary to make the

156

determination required in paragraph (1). −SOURCE− (July 1, 1944, ch. 373, title XIX, Sec. 1930, as added Pub. L. 102−321, title II, Sec. 202, July 10, 1992, 106 Stat. 397; amended Pub. L. 106−310, div. B, title XXXIII, Sec. 3303(c), Oct. 17, 2000, 114 Stat. 1210.) −MISC1− PRIOR PROVISIONS A prior section 1930 of act July 1, 1944, was classified to section 300y−9 of this title prior to repeal by Pub. L. 99−280. AMENDMENTS 2000 − Subsecs. (b) to (d). Pub. L. 106−310 added subsec. (b) and redesignated former subsecs. (b) and (c) as (c) and (d), respectively. −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in sections 300x−32, 300x−54, 300x−55 of this title. −End− −CITE− 42 USC Sec. 300x−31 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XVII − BLOCK GRANTS Part B − Block Grants Regarding Mental Health and Substance Abuse

157

subpart ii − block grants for prevention and treatment of substance abuse −HEAD− Sec. 300x−31. Restrictions on expenditure of grant −STATUTE− (a) In general (1) Certain restrictions A funding agreement for a grant under section 300x−21 of this title is that the State involved will not expend the grant − (A) to provide inpatient hospital services, except as provided in subsection (b) of this section; (B) to make cash payments to intended recipients of health services; (C) to purchase or improve land, purchase, construct, or permanently improve (other than minor remodeling) any building or other facility, or purchase major medical equipment; (D) to satisfy any requirement for the expenditure of non−Federal funds as a condition for the receipt of Federal funds; (E) to provide financial assistance to any entity other than a public or nonprofit private entity; or (F) to carry out any program prohibited by section 300ee−5 of this title. (2) Limitation on administrative expenses A funding agreement for a grant under section 300x−21 of this title is that the State involved will not expend more than 5

158

percent of the grant to pay the costs of administering the grant. (3) Limitation regarding penal and correctional institutions A funding agreement for a State for a grant under section 300x−21 of this title is that, in expending the grant for the purpose of providing treatment services in penal or correctional institutions of the State, the State will not expend more than an amount equal to the amount expended for such purpose by the State from the grant made under section 300x−1a (!1) of this title to the State for fiscal year 1991 (as section 300x−1a (!1) of this title was in effect for such fiscal year). (b) Exception regarding inpatient hospital services (1) Medical necessity as precondition With respect to compliance with the agreement made under subsection (a) of this section, a State may expend a grant under section 300x−21 of this title to provide inpatient hospital services as treatment for substance abuse only if it has been determined, in accordance with guidelines issued by the Secretary, that such treatment is a medical necessity for the individual involved, and that the individual cannot be effectively treated in a community−based, nonhospital, residential program of treatment. (2) Rate of payment In the case of an individual for whom a grant under section 300x−21 of this title is expended to provide inpatient hospital services described in paragraph (1), a funding agreement for the grant for the State involved is that the daily rate of payment

159

provided to the hospital for providing the services to the individual will not exceed the comparable daily rate provided for community−based, nonhospital, residential programs of treatment for substance abuse. (c) Waiver regarding construction of facilities (1) In general The Secretary may provide to any State a waiver of the restriction established in subsection (a)(1)(C) of this section for the purpose of authorizing the State to expend a grant under section 300x−21 of this title for the construction of a new facility or rehabilitation of an existing facility, but not for land acquisition. (2) Standard regarding need for waiver The Secretary may approve a waiver under paragraph (1) only if the State demonstrates to the Secretary that adequate treatment cannot be provided through the use of existing facilities and that alternative facilities in existing suitable buildings are not available. (3) Amount In granting a waiver under paragraph (1), the Secretary shall allow the use of a specified amount of funds to construct or rehabilitate a specified number of beds for residential treatment and a specified number of slots for outpatient treatment, based on reasonable estimates by the State of the costs of construction or rehabilitation. In considering waiver applications, the Secretary shall ensure that the State has carefully designed a

160

program that will minimize the costs of additional beds. (4) Matching funds The Secretary may grant a waiver under paragraph (1) only if the State agrees, with respect to the costs to be incurred by the State in carrying out the purpose of the waiver, to make available non−Federal contributions in cash toward such costs in an amount equal to not less than $1 for each $1 of Federal funds provided under section 300x−21 of this title. (5) Date certain for acting upon request The Secretary shall act upon a request for a waiver under paragraph (1) not later than 120 days after the date on which the request is made. −SOURCE− (July 1, 1944, ch. 373, title XIX, Sec. 1931, as added Pub. L. 102−321, title II, Sec. 202, July 10, 1992, 106 Stat. 397.) −REFTEXT− REFERENCES IN TEXT Section 300x−1a of this title, referred to in subsec. (a)(3), was repealed by Pub. L. 102−321, title II, Sec. 201(2), July 10, 1992, 106 Stat. 378. −MISC1− PRIOR PROVISIONS A prior section 1931 of act July 1, 1944, was classified to section 300y−21 of this title and subsequently omitted from the Code. Another prior section 1931 of act July 1, 1944, was classified to

161

section 300y−10 of this title prior to repeal by Pub. L. 99−280. −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in sections 300x−21, 300x−24, 300x−32, 300x−34, 1395x of this title. −FOOTNOTE− (!1) See References in Text note below. −End− −CITE− 42 USC Sec. 300x−32 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XVII − BLOCK GRANTS Part B − Block Grants Regarding Mental Health and Substance Abuse subpart ii − block grants for prevention and treatment of substance abuse −HEAD− Sec. 300x−32. Application for grant; approval of State plan −STATUTE− (a) In general For purposes of section 300x−21 of this title, an application for a grant under such section for a fiscal year is in accordance with this section if, subject to subsections (c) and (d)(2) of this section − (1) the application is received by the Secretary not later than

162

October 1 of the fiscal year for which the State is seeking funds; (2) the application contains each funding agreement that is described in this subpart or subpart III for such a grant (other than any such agreement that is not applicable to the State); (3) the agreements are made through certification from the chief executive officer of the State; (4) with respect to such agreements, the application provides assurances of compliance satisfactory to the Secretary; (5) the application contains the information required in section 300x−29 of this title, the information required in section 300x−30(c)(2) (!1) of this title, and the report required in section 300x−52(a) of this title; (6)(A) the application contains a plan in accordance with subsection (b) of this section and the plan is approved by the Secretary; and (B) the State provides assurances satisfactory to the Secretary that the State complied with the provisions of the plan under subparagraph (A) that was approved by the Secretary for the most recent fiscal year for which the State received a grant under section 300x−21 of this title; and (7) the application (including the plan under paragraph (6)) is otherwise in such form, is made in such manner, and contains such agreements, assurances, and information as the Secretary determines to be necessary to carry out this subpart. (b) State plan

163

(1) In general A plan submitted by a State under subsection (a)(6) of this section is in accordance with this subsection if the plan contains detailed provisions for complying with each funding agreement for a grant under section 300x−21 of this title that is applicable to the State, including a description of the manner in which the State intends to expend the grant. (2) Authority of Secretary regarding modifications As a condition of making a grant under section 300x−21 of this title to a State for a fiscal year, the Secretary may require that the State modify any provision of the plan submitted by the State under subsection (a)(6) of this section (including provisions on priorities in carrying out authorized activities). If the Secretary approves the plan and makes the grant to the State for the fiscal year, the Secretary may not during such year require the State to modify the plan. (3) Authority of Center for Substance Abuse Prevention With respect to plans submitted by the States under subsection (a)(6) of this section, the Secretary, acting through the Director of the Center for Substance Abuse Prevention, shall review and approve or disapprove the provisions of the plans that relate to prevention activities. (c) Waivers regarding certain territories In the case of any territory of the United States except Puerto Rico, the Secretary may waive such provisions of this subpart and subpart III as the Secretary determines to be appropriate, other

164

than the provisions of section 300x−31 of this title. (d) Issuance of regulations; precondition to making grants (1) Regulations Not later than August 25, 1992, the Secretary, acting as appropriate through the Director of the Center for Treatment Improvement or the Director of the Center for Substance Abuse Prevention, shall by regulation establish standards specifying the circumstances in which the Secretary will consider an application for a grant under section 300x−21 of this title to be in accordance with this section. (2) Issuance as precondition to making grants The Secretary may not make payments under any grant under section 300x−21 of this title for fiscal year 1993 on or after January 1, 1993, unless the Secretary has issued standards under paragraph (1). (e) Waiver authority for certain requirements (1) In general Upon the request of a State, the Secretary may waive the requirements of all or part of the sections described in paragraph (2) using objective criteria established by the Secretary by regulation after consultation with the States and other interested parties including consumers and providers. (2) Sections The sections described in paragraph (1) are sections 300x−22(c) (!1), 300x−23, 300x−24 and 300x−28 of this title. (3) Date certain for acting upon request

165

The Secretary shall approve or deny a request for a waiver under paragraph (1) and inform the State of that decision not later than 120 days after the date on which the request and all the information needed to support the request are submitted. (4) Annual reporting requirement The Secretary shall annually report to the general public on the States that receive a waiver under this subsection. −SOURCE− (July 1, 1944, ch. 373, title XIX, Sec. 1932, as added Pub. L. 102−321, title II, Sec. 202, July 10, 1992, 106 Stat. 399; amended Pub. L. 106−310, div. B, title XXXIII, Sec. 3303(d)−(f)(1), Oct. 17, 2000, 114 Stat. 1211.) −REFTEXT− REFERENCES IN TEXT Section 300x−30(c) of this title, referred to in subsec. (a)(5), was redesignated section 300x−30(d) of this title by Pub. L. 106−310, div. B, title XXXIII, Sec. 3303(c)(1), Oct. 17, 2000, 114 Stat. 1211. Section 300x−22(c) of this title, referred to in subsec. (e)(2), was redesignated section 300x−22(b) of this title by Pub. L. 106−310, div. B, title XXXIII, Sec. 3303(a)(2), Oct. 17, 2000, 114 Stat. 1210. −MISC1− PRIOR PROVISIONS A prior section 1932 of act July 1, 1944, was classified to section 300y−22 of this title and subsequently omitted from the

166

Code. Another prior section 1932 of act July 1, 1944, was classified to section 300y−11 of this title prior to repeal by Pub. L. 99−280. AMENDMENTS 2000 − Subsec. (a)(1). Pub. L. 106−310, Sec. 3303(d), amended par. (1) generally. Prior to amendment, par. (1) read as follows: "the State involved submits the application not later than the date specified by the Secretary;". Subsec. (c). Pub. L. 106−310, Sec. 3303(e), substituted "except Puerto Rico" for "whose allotment under section 300x−21 of this title for the fiscal year is the amount specified in section 300x−33(c)(2)(B) of this title". Subsec. (e). Pub. L. 106−310, Sec. 3303(f)(1), added subsec. (e). −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in sections 290bb, 300x−21, 300x−51 of this title. −FOOTNOTE− (!1) See References in Text note below. −End− −CITE− 42 USC Sec. 300x−33 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XVII − BLOCK GRANTS

167

Part B − Block Grants Regarding Mental Health and Substance Abuse subpart ii − block grants for prevention and treatment of substance abuse −HEAD− Sec. 300x−33. Determination of amount of allotment −STATUTE− (a) States (1) In general Subject to subsection (b) of this section, the Secretary shall determine the amount of the allotment required in section 300x−21 of this title for a State for a fiscal year as follows: (A) The formula established in paragraph (1) of section 300x−7(a) of this title shall apply to this subsection to the same extent and in the same manner as the formula applies for purposes of section 300x−7(a) of this title, except that, in the application of such formula for purposes of this subsection, the modifications described in subparagraph (B) shall apply. (B) For purposes of subparagraph (A), the modifications described in this subparagraph are as follows: (i) The amount specified in paragraph (2)(A) of section 300x−7(a) of this title is deemed to be the amount appropriated under section 300x−35(a) of this title for allotments under section 300x−21 of this title for the fiscal year involved. (ii) The term "P" is deemed to have the meaning given in

168

paragraph (2) of this subsection. Section 300x−7(a)(5)(B) of this title applies to the data used in determining such term for the States. (iii) The factor determined under paragraph (8) of section 300x−7(a) of this title is deemed to have the purpose of reflecting the differences that exist between the State involved and other States in the costs of providing authorized services. (2) Determination of term "P" For purposes of this subsection, the term "P" means the percentage that is the arithmetic mean of the percentage determined under subparagraph (A) and the percentage determined under subparagraph (B), as follows: (A) The percentage constituted by the ratio of − (i) an amount equal to the sum of the total number of individuals who reside in the State involved and are between 18 and 24 years of age (inclusive) and the number of individuals in the State who reside in urbanized areas of the State and are between such years of age; to (ii) an amount equal to the total of the respective sums determined for the States under clause (i). (B) The percentage constituted by the ratio of − (i) the total number of individuals in the State who are between 25 and 64 years of age (inclusive); to (ii) an amount equal to the sum of the respective amounts determined for the States under clause (i).

169

(b) Minimum allotments for States (1) In general With respect to fiscal year 2000, and each subsequent fiscal year, the amount of the allotment of a State under section 300x−21 of this title shall not be less than the amount the State received under such section for the previous fiscal year increased by an amount equal to 30.65 percent of the percentage by which the aggregate amount allotted to all States for such fiscal year exceeds the aggregate amount allotted to all States for the previous fiscal year. (2) Limitations (A) In general Except as provided in subparagraph (B), a State shall not receive an allotment under section 300x−21 of this title for a fiscal year in an amount that is less than an amount equal to 0.375 percent of the amount appropriated under section 300x−35(a) of this title for such fiscal year. (B) Exception In applying subparagraph (A), the Secretary shall ensure that no State receives an increase in its allotment under section 300x−21 of this title for a fiscal year (as compared to the amount allotted to the State in the prior fiscal year) that is in excess of an amount equal to 300 percent of the percentage by which the amount appropriated under section 300x−35(a) of this title for such fiscal year exceeds the amount appropriated for the prior fiscal year.

170

(3) Decrease in or equal appropriations If the amount appropriated under section 300x−35(a) of this title for a fiscal year is equal to or less than the amount appropriated under such section for the prior fiscal year, the amount of the State allotment under section 300x−21 of this title shall be equal to the amount that the State received under section 300x−21 of this title in the prior fiscal year decreased by the percentage by which the amount appropriated for such fiscal year is less than the amount appropriated or (!1) such section for the prior fiscal year. (c) Territories (1) Determination under formula Subject to paragraphs (2) and (4), the amount of an allotment under section 300x−21 of this title for a territory of the United States for a fiscal year shall be the product of − (A) an amount equal to the amounts reserved under paragraph (3) for the fiscal year; and (B) a percentage equal to the quotient of − (i) the civilian population of the territory, as indicated by the most recently available data; divided by (ii) the aggregate civilian population of the territories of the United States, as indicated by such data. (2) Minimum allotment for territories The amount of an allotment under section 300x−21 of this title for a territory of the United States for a fiscal year shall be the greater of −

171

(A) the amount determined under paragraph (1) for the territory for the fiscal year; (B) $50,000; and (C) with respect to fiscal years 1993 and 1994, an amount equal to 79.4 percent of the amount received by the territory from allotments made pursuant to this part for fiscal year 1992. (3) Reservation of amounts The Secretary shall each fiscal year reserve for the territories of the United States 1.5 percent of the amounts appropriated under section 300x−35(a) of this title for allotments under section 300x−21 of this title for the fiscal year. (4) Availability of data on population With respect to data on the civilian population of the territories of the United States, if the Secretary determines for a fiscal year that recent such data for purposes of paragraph (1)(B) do not exist regarding a territory, the Secretary shall for such purposes estimate the civilian population of the territory by modifying the data on the territory to reflect the average extent of change occurring during the ensuing period in the population of all territories with respect to which recent such data do exist. (5) Applicability of certain provisions For purposes of subsections (a) and (b) of this section, the term "State" does not include the territories of the United

172

States. (d) Indian tribes and tribal organizations (1) In general If the Secretary − (A) receives a request from the governing body of an Indian tribe or tribal organization within any State that funds under this subpart be provided directly by the Secretary to such tribe or organization; and (B) makes a determination that the members of such tribe or tribal organization would be better served by means of grants made directly by the Secretary under this; (!2) the Secretary shall reserve from the allotment under section 300x−21 of this title for the State for the fiscal year involved an amount that bears the same ratio to the allotment as the amount provided under this subpart to the tribe or tribal organization for fiscal year 1991 for activities relating to the prevention and treatment of the abuse of alcohol and other drugs bore to the amount of the portion of the allotment under this subpart for the State for such fiscal year that was expended for such activities. (2) Tribe or tribal organization as grantee The amount reserved by the Secretary on the basis of a determination under this paragraph (!3) shall be granted to the Indian tribe or tribal organization serving the individuals for whom such a determination has been made. (3) Application

173

In order for an Indian tribe or tribal organization to be eligible for a grant for a fiscal year under this paragraph,(!3) it shall submit to the Secretary a plan for such fiscal year that meets such criteria as the Secretary may prescribe. (4) Definitions The terms "Indian tribe" and "tribal organization" have the same meaning given such terms in subsections (b) and (c) (!4) of section 450b of title 25. −SOURCE− (July 1, 1944, ch. 373, title XIX, Sec. 1933, as added Pub. L. 102−321, title II, Sec. 202, July 10, 1992, 106 Stat. 400; amended Pub. L. 102−352, Sec. 2(a)(11), Aug. 26, 1992, 106 Stat. 938; Pub. L. 105−277, div. A, Sec. 101(f) [title II, Sec. 218(b)], Oct. 21, 1998, 112 Stat. 2681−337, 2681−362; Pub. L. 106−113, div. B, Sec. 1000(a)(4) [title II, Sec. 212(b)], Nov. 29, 1999, 113 Stat. 1535, 1501A−239; Pub. L. 106−310, div. B, title XXXIII, Sec. 3304, Oct. 17, 2000, 114 Stat. 1212.) −REFTEXT− REFERENCES IN TEXT Section 450b of title 25, referred to in subsec. (d)(4), was amended, and subsecs. (b) and (c) of section 450 no longer define the terms "Indian tribe" and "tribal organization". However, such terms are defined elsewhere in that section. −MISC1− PRIOR PROVISIONS A prior section 1933 of act July 1, 1944, was classified to

174

section 300y−23 of this title and subsequently omitted from the Code. AMENDMENTS 2000 − Subsec. (b). Pub. L. 106−310 reenacted heading without change and amended text generally. Prior to amendment, text read as follows: "Each State's allotment for fiscal year 2000 for programs under this subpart shall be equal to such State's allotment for such programs for fiscal year 1999, except that, if the amount appropriated in fiscal year 2000 is less than the amount appropriated in fiscal year 1999, then the amount of a State's allotment under section 300x−21 of this title shall be equal to the amount that the State received under section 300x−21 of this title in fiscal year 1999 decreased by the percentage by which the amount appropriated for fiscal year 2000 is less than the amount appropriated for such section for fiscal year 1999." 1999 − Subsec. (b). Pub. L. 106−113 amended heading and text of subsec. (b) generally. Prior to amendment, text read as follows: "For each of the fiscal years 1993 and 1994, the amount of the allotment required in section 300x−21 of this title for a State for the fiscal year involved shall be the greater of − "(1) the amount determined under subsection (a) of this section for the State for the fiscal year; and "(2) an amount equal to 79.4 percent of the amount received by the State from allotments made pursuant to this part for fiscal year 1992 (including reallotments under section 205(a) of the ADAMHA Reorganization Act)."

175

1998 − Subsec. (b). Pub. L. 105−277, temporarily amended subsec. (b) to read as follows: "(b) Minimum allotments for States. − "(1) In general. − With respect to fiscal year 1999, the amount of the allotment of a State under section 300x−21 of this title shall not be less than the amount the State received under section 300x−21 of this title for fiscal year 1998 increased by 30.65 percent of the percentage by which the amount allotted to the States for fiscal year 1999 exceeds the amount allotted to the States for fiscal year 1998. "(2) Limitation "(A) In general. − Except as provided in subparagraph (B), a State shall not receive an allotment under section 300x−21 of this title for fiscal year 1999 in an amount that is less than an amount equal to 0.375 percent of the amount appropriated under section 300x−35(a) of this title for such fiscal year. "(B) Exception. − In applying subparagraph (A), the Secretary shall ensure that no State receives an increase in its allotment under section 300x−21 of this title for fiscal year 1999 (as compared to the amount allotted to the State in the fiscal year 1998) that is in excess of an amount equal to 300 percent of the percentage by which the amount appropriated under section 300x−35(a) of this title for fiscal year 1999 exceeds the amount appropriated for the prior fiscal year. "(3) Only for the purposes of calculating minimum allotments under this subsection, any reference to the amount appropriated under section 300x−35(a) of this title for fiscal year 1998,

176

allotments to States under section 300x−21 of this title and any references to amounts received by States in fiscal year 1998 shall include amounts appropriated or received under the amendments made by section 105 of the Contract with America Advancement Act of 1996 (Public Law 104−121)." See Effective and Termination Dates of 1998 Amendment note below. 1992 − Subsec. (c)(2)(C). Pub. L. 102−352 added subpar. (C). EFFECTIVE AND TERMINATION DATES OF 1998 AMENDMENT Amendment by Pub. L. 105−277 effective as if enacted on Oct. 1, 1998, and applicable only during fiscal year 1999, and upon expiration of fiscal year 1999, subsec. (b) of this section, as in effect on Sept. 30, 1998, to be applied as if such amendment had not been enacted, see section 101(f) [title II, Sec. 218(c)] of Pub. L. 105−277, set out as a note under section 300x−7 of this title. EFFECTIVE DATE OF 1992 AMENDMENT Amendment by Pub. L. 102−352 effective immediately upon effectuation of amendment made by Pub. L. 102−321, see section 3(1) of Pub. L. 102−352, set out as a note under section 285n of this title. −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in sections 300x−21, 300x−26, 300x−64 of this title. −FOOTNOTE− (!1) So in original. Probably should be "for".

177

(!2) So in original. Probably should be "this subpart;". (!3) So in original. Probably should be "subsection". (!4) See References in Text note below. −End− −CITE− 42 USC Sec. 300x−34 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XVII − BLOCK GRANTS Part B − Block Grants Regarding Mental Health and Substance Abuse subpart ii − block grants for prevention and treatment of substance abuse −HEAD− Sec. 300x−34. Definitions −STATUTE− For purposes of this subpart: (1) The term "authorized activities", subject to section 300x−31 of this title, means the activities described in section 300x−21(b) of this title. (2) The term "funding agreement", with respect to a grant under section 300x−21 of this title to a State, means that the Secretary may make such a grant only if the State makes the agreement involved. (3) The term "prevention activities", subject to section 300x−31 of this title, means activities to prevent substance

178

abuse. (4) The term "substance abuse" means the abuse of alcohol or other drugs. (5) The term "treatment activities" means treatment services and, subject to section 300x−31 of this title, authorized activities that are related to treatment services. (6) The term "treatment facility" means an entity that provides treatment services. (7) The term "treatment services", subject to section 300x−31 of this title, means treatment for substance abuse. −SOURCE− (July 1, 1944, ch. 373, title XIX, Sec. 1934, as added Pub. L. 102−321, title II, Sec. 202, July 10, 1992, 106 Stat. 402.) −MISC1− PRIOR PROVISIONS A prior section 1934 of act July 1, 1944, was classified to section 300y−24 of this title and subsequently omitted from the Code. −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in section 300x−64 of this title. −End− −CITE− 42 USC Sec. 300x−35 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE

179

CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XVII − BLOCK GRANTS Part B − Block Grants Regarding Mental Health and Substance Abuse subpart ii − block grants for prevention and treatment of substance abuse −HEAD− Sec. 300x−35. Funding −STATUTE− (a) Authorization of appropriations For the purpose of carrying out this subpart, subpart III and section 290aa−4 of this title with respect to substance abuse, and section 290bb−21(d) of this title, there are authorized to be appropriated $2,000,000,000 for fiscal year 2001, and such sums as may be necessary for each of the fiscal years 2002 and 2003. (b) Allocations for technical assistance, national data base, data collection, and program evaluations (1) In general (A) For the purpose of carrying out section 300x−58(a) of this title with respect to substance abuse, section 290bb−21(d) of this title, and the purposes specified in subparagraphs (B) and (C), the Secretary shall obligate 5 percent of the amounts appropriated under subsection (a) of this section each fiscal year. (B) The purpose specified in this subparagraph is the collection of data in this paragraph (!1) is carrying out sections 290aa−4 and 300y of this title with respect to substance

180

abuse. (C) The purpose specified in this subparagraph is the conduct of evaluations of authorized activities to determine methods for improving the availability and quality of such activities. (2) Activities of Center for Substance Abuse Prevention Of the amounts reserved under paragraph (1) for a fiscal year, the Secretary, acting through the Director of the Center for Substance Abuse Prevention, shall obligate 20 percent for carrying out paragraph (1)(C), section 300x−58(a) of this title with respect to prevention activities, and section 290bb−21(d) of this title. (3) Core data set A State that receives a new grant, contract, or cooperative agreement from amounts available to the Secretary under paragraph (1), for the purposes of improving the data collection, analysis and reporting capabilities of the State, shall be required, as a condition of receipt of funds, to collect, analyze, and report to the Secretary for each fiscal year subsequent to receiving such funds a core data set to be determined by the Secretary in conjunction with the States. −SOURCE− (July 1, 1944, ch. 373, title XIX, Sec. 1935, as added Pub. L. 102−321, title II, Sec. 202, July 10, 1992, 106 Stat. 403; amended Pub. L. 106−310, div. B, title XXXIII, Sec. 3303(g), Oct. 17, 2000, 114 Stat. 1211.) −MISC1−

181

PRIOR PROVISIONS A prior section 1935 of act July 1, 1944, was classified to section 300y−25 of this title and subsequently omitted from the Code. AMENDMENTS 2000 − Subsec. (a). Pub. L. 106−310, Sec. 3303(g)(1), substituted "$2,000,000,000 for fiscal year 2001, and such sums as may be necessary for each of the fiscal years 2002 and 2003" for "$1,500,000,000 for fiscal year 1993, and such sums as may be necessary for fiscal year 1994". Subsec. (b)(1)(B). Pub. L. 106−310, Sec. 3303(g)(2), substituted "sections 290aa−4 and 300y of this title" for "section 290aa−4 of this title". Subsec. (b)(2). Pub. L. 106−310, Sec. 3303(g)(3), made technical amendment to reference in original act which appears in text as reference to section 300x−58(a) of this title. Subsec. (b)(3). Pub. L. 106−310, Sec. 3303(g)(4), added par. (3). −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in section 300x−33 of this title. −FOOTNOTE− (!1) So in original. The words "is the collection of data in this paragraph" probably should not appear. −End− −CITE− 42 USC subpart iii − general provisions 01/06/03

182

−EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XVII − BLOCK GRANTS Part B − Block Grants Regarding Mental Health and Substance Abuse subpart iii − general provisions −HEAD− SUBPART III − GENERAL PROVISIONS −SECREF− SUBPART REFERRED TO IN OTHER SECTIONS This subpart is referred to in sections 300x−6, 300x−9, 300x−32, 300x−35 of this title. −End− −CITE− 42 USC Sec. 300x−51 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XVII − BLOCK GRANTS Part B − Block Grants Regarding Mental Health and Substance Abuse subpart iii − general provisions −HEAD− Sec. 300x−51. Opportunity for public comment on State plans −STATUTE− A funding agreement for a grant under section 300x or 300x−21 of this title is that the State involved will make the plan required

183

in section 300x−1 of this title, and the plan required in section 300x−32 of this title, respectively, public within the State in such manner as to facilitate comment from any person (including any Federal or other public agency) during the development of the plan (including any revisions) and after the submission of the plan to the Secretary. −SOURCE− (July 1, 1944, ch. 373, title XIX, Sec. 1941, as added Pub. L. 102−321, title II, Sec. 203(a), July 10, 1992, 106 Stat. 403.) −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in section 300x−6 of this title. −End− −CITE− 42 USC Sec. 300x−52 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XVII − BLOCK GRANTS Part B − Block Grants Regarding Mental Health and Substance Abuse subpart iii − general provisions −HEAD− Sec. 300x−52. Requirement of reports and audits by States −STATUTE− (a) Report A funding agreement for a grant under section 300x or 300x−21 of

184

this title is that the State involved will submit to the Secretary a report in such form and containing such information as the Secretary determines (after consultation with the States) to be necessary for securing a record and a description of − (1) the purposes for which the grant received by the State for the preceding fiscal year under the program involved were expended and a description of the activities of the State under the program; and (2) the recipients of amounts provided in the grant. (b) Audits A funding agreement for a grant under section 300x or 300x−21 of this title is that the State will, with respect to the grant, comply with chapter 75 of title 31. (c) Availability to public A funding agreement for a grant under section 300x or 300x−21 of this title is that the State involved will − (1) make copies of the reports and audits described in this section available for public inspection within the State; and (2) provide copies of the report under subsection (a) of this section, upon request, to any interested person (including any public agency). −SOURCE− (July 1, 1944, ch. 373, title XIX, Sec. 1942, as added Pub. L. 102−321, title II, Sec. 203(a), July 10, 1992, 106 Stat. 403; amended Pub. L. 104−316, title I, Sec. 122(e), Oct. 19, 1996, 110 Stat. 3837.)

185

−MISC1− AMENDMENTS 1996 − Subsec. (a). Pub. L. 104−316 struck out "and the Comptroller General" after "with the States" in introductory provisions. −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in sections 300x−4, 300x−6, 300x−32 of this title. −End− −CITE− 42 USC Sec. 300x−53 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XVII − BLOCK GRANTS Part B − Block Grants Regarding Mental Health and Substance Abuse subpart iii − general provisions −HEAD− Sec. 300x−53. Additional requirements −STATUTE− (a) In general A funding agreement for a grant under section 300x or 300x−21 of this title is that the State involved will − (1)(A) for the fiscal year for which the grant involved is provided, provide for independent peer review to assess the

186

quality, appropriateness, and efficacy of treatment services provided in the State to individuals under the program involved; and (B) ensure that, in the conduct of such peer review, not fewer than 5 percent of the entities providing services in the State under such program are reviewed (which 5 percent is representative of the total population of such entities); (2) permit and cooperate with Federal investigations undertaken in accordance with section 300x−55 of this title; and (3) provide to the Secretary any data required by the Secretary pursuant to section 290aa−4 of this title and will cooperate with the Secretary in the development of uniform criteria for the collection of data pursuant to such section. (b) Patient records The Secretary may make a grant under section 300x or 300x−21 of this title only if the State involved has in effect a system to protect from inappropriate disclosure patient records maintained by the State in connection with an activity funded under the program involved or by any entity which is receiving amounts from the grant. −SOURCE− (July 1, 1944, ch. 373, title XIX, Sec. 1943, as added Pub. L. 102−321, title II, Sec. 203(a), July 10, 1992, 106 Stat. 404; amended Pub. L. 102−352, Sec. 2(a)(12), Aug. 26, 1992, 106 Stat. 939.) −MISC1−

187

AMENDMENTS 1992 − Subsec. (a)(3). Pub. L. 102−352 substituted "section 290aa−4 of this title" for "section 290bb−21 of this title". EFFECTIVE DATE OF 1992 AMENDMENT Amendment by Pub. L. 102−352 effective immediately upon effectuation of amendment made by Pub. L. 102−321, see section 3(1) of Pub. L. 102−352, set out as a note under section 285n of this title. −End− −CITE− 42 USC Sec. 300x−54 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XVII − BLOCK GRANTS Part B − Block Grants Regarding Mental Health and Substance Abuse subpart iii − general provisions −HEAD− Sec. 300x−54. Disposition of certain funds appropriated for allotments −STATUTE− (a) In general Amounts described in subsection (b) of this section and available for a fiscal year pursuant to section 300x or 300x−21 of this title, as the case may be, shall be allotted by the Secretary and paid to the States receiving a grant under the program involved,

188

other than any State referred to in subsection (b) of this section with respect to such program. Such amounts shall be allotted in a manner equivalent to the manner in which the allotment under the program involved was determined. (b) Specification of amounts The amounts referred to in subsection (a) of this section are any amounts that − (1) are not paid to States under the program involved as a result of − (A) the failure of any State to submit an application in accordance with the program; (B) the failure of any State to prepare such application in compliance with the program; or (C) any State informing the Secretary that the State does not intend to expend the full amount of the allotment made to the State under the program; (2) are terminated, repaid, or offset under section 300x−55 of this title; (3) in the case of the program established in section 300x of this title, are available as a result of reductions in allotments under such section pursuant to section 300x−1(d) or 300x−4(b) of this title; or (4) in the case of the program established in section 300x−21 of this title, are available as a result of reductions in allotments under such section pursuant to section 300x−26 or 300x−30 of this title.

189

−SOURCE− (July 1, 1944, ch. 373, title XIX, Sec. 1944, as added Pub. L. 102−321, title II, Sec. 203(a), July 10, 1992, 106 Stat. 404.) −End− −CITE− 42 USC Sec. 300x−55 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XVII − BLOCK GRANTS Part B − Block Grants Regarding Mental Health and Substance Abuse subpart iii − general provisions −HEAD− Sec. 300x−55. Failure to comply with agreements −STATUTE− (a) Suspension or termination of payments Subject to subsection (e) of this section, if the Secretary determines that a State has materially failed to comply with the agreements or other conditions required for the receipt of a grant under the program involved, the Secretary may in whole or in part suspend payments under the grant, terminate the grant for cause, or employ such other remedies (including the remedies provided for in subsections (b) and (c) of this section) as may be legally available and appropriate in the circumstances involved. (b) Repayment of payments (1) In general

190

Subject to subsection (e) of this section, the Secretary may require a State to repay with interest any payments received by the State under section 300x or 300x−21 of this title that the Secretary determines were not expended by the State in accordance with the agreements required under the program involved. (2) Offset against payments If a State fails to make a repayment required in paragraph (1), the Secretary may offset the amount of the repayment against the amount of any payment due to be paid to the State under the program involved. (c) Withholding of payments (1) In general Subject to subsections (e) and (g)(3) of this section, the Secretary may withhold payments due under section 300x or 300x−21 of this title if the Secretary determines that the State involved is not expending amounts received under the program involved in accordance with the agreements required under the program. (2) Termination of withholding The Secretary shall cease withholding payments from a State under paragraph (1) if the Secretary determines that there are reasonable assurances that the State will expend amounts received under the program involved in accordance with the agreements required under the program. (d) Applicability of remedies to certain violations (1) In general With respect to agreements or other conditions for receiving a

191

grant under the program involved, in the case of the failure of a State to maintain material compliance with a condition referred to in paragraph (2), the provisions for noncompliance with the condition that are provided in the section establishing the condition shall apply in lieu of subsections (a) through (c) of this section. (2) Relevant conditions For purposes of paragraph (1): (A) In the case of the program established in section 300x of this title, a condition referred to in this paragraph is the condition established in section 300x−1(d) of this title and the condition established in section 300x−4(b) of this title. (B) In the case of the program established in section 300x−21 of this title, a condition referred to in this paragraph is the condition established in section 300x−26 of this title and the condition established in section 300x−30 of this title. (e) Opportunity for hearing Before taking action against a State under any of subsections (a) through (c) of this section (or under a section referred to in subsection (d)(2) of this section, as the case may be), the Secretary shall provide to the State involved adequate notice and an opportunity for a hearing. (f) Requirement of hearing in certain circumstances (1) In general If the Secretary receives a complaint that a State has failed to maintain material compliance with the agreements or other

192

conditions required for receiving a grant under the program involved (including any condition referred to for purposes of subsection (d) of this section), and there appears to be reasonable evidence to support the complaint, the Secretary shall promptly conduct a hearing with respect to the complaint. (2) Finding of material noncompliance If in a hearing under paragraph (1) the Secretary finds that the State involved has failed to maintain material compliance with the agreement or other condition involved, the Secretary shall take such action under this section as may be appropriate to ensure that material compliance is so maintained, or such action as may be required in a section referred to in subsection (d)(2) of this section, as the case may be. (g) Certain investigations (1) Requirement regarding Secretary The Secretary shall in fiscal year 1994 and each subsequent fiscal year conduct in not less than 10 States investigations of the expenditure of grants received by the States under section 300x or 300x−21 of this title in order to evaluate compliance with the agreements required under the program involved. (2) Provision of records, etc., upon request Each State receiving a grant under section 300x or 300x−21 of this title, and each entity receiving funds from the grant, shall make appropriate books, documents, papers, and records available to the Secretary or the Comptroller General, or any of their duly authorized representatives, for examination, copying, or

193

mechanical reproduction on or off the premises of the appropriate entity upon a reasonable request therefor. (3) Limitations on authority The Secretary may not institute proceedings under subsection (c) of this section unless the Secretary has conducted an investigation concerning whether the State has expended payments under the program involved in accordance with the agreements required under the program. Any such investigation shall be conducted within the State by qualified investigators. −SOURCE− (July 1, 1944, ch. 373, title XIX, Sec. 1945, as added Pub. L. 102−321, title II, Sec. 203(a), July 10, 1992, 106 Stat. 405.) −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in sections 300x−53, 300x−54 of this title. −End− −CITE− 42 USC Sec. 300x−56 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XVII − BLOCK GRANTS Part B − Block Grants Regarding Mental Health and Substance Abuse subpart iii − general provisions −HEAD−

194

Sec. 300x−56. Prohibitions regarding receipt of funds −STATUTE− (a) Establishment (1) Certain false statements and representations A person shall not knowingly and willfully make or cause to be made any false statement or representation of a material fact in connection with the furnishing of items or services for which payments may be made by a State from a grant made to the State under section 300x or 300x−21 of this title. (2) Concealing or failing to disclose certain events A person with knowledge of the occurrence of any event affecting the initial or continued right of the person to receive any payments from a grant made to a State under section 300x or 300x−21 of this title shall not conceal or fail to disclose any such event with an intent fraudulently to secure such payment either in a greater amount than is due or when no such amount is due. (b) Criminal penalty for violation of prohibition Any person who violates any prohibition established in subsection (a) of this section shall for each violation be fined in accordance with title 18 or imprisoned for not more than 5 years, or both. −SOURCE− (July 1, 1944, ch. 373, title XIX, Sec. 1946, as added Pub. L. 102−321, title II, Sec. 203(a), July 10, 1992, 106 Stat. 406.) −End− −CITE−

195

42 USC Sec. 300x−57 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XVII − BLOCK GRANTS Part B − Block Grants Regarding Mental Health and Substance Abuse subpart iii − general provisions −HEAD− Sec. 300x−57. Nondiscrimination −STATUTE− (a) In general (1) Rule of construction regarding certain civil rights laws For the purpose of applying the prohibitions against discrimination on the basis of age under the Age Discrimination Act of 1975 [42 U.S.C. 6101 et seq.], on the basis of handicap under section 504 of the Rehabilitation Act of 1973 [29 U.S.C. 794], on the basis of sex under title IX of the Education Amendments of 1972 [20 U.S.C. 1681 et seq.], or on the basis of race, color, or national origin under title VI of the Civil Rights Act of 1964 [42 U.S.C. 2000d et seq.], programs and activities funded in whole or in part with funds made available under section 300x or 300x−21 of this title shall be considered to be programs and activities receiving Federal financial assistance. (2) Prohibition No person shall on the ground of sex (including, in the case of

196

a woman, on the ground that the woman is pregnant), or on the ground of religion, be excluded from participation in, be denied the benefits of, or be subjected to discrimination under, any program or activity funded in whole or in part with funds made available under section 300x or 300x−21 of this title. (b) Enforcement (1) Referrals to Attorney General after notice Whenever the Secretary finds that a State, or an entity that has received a payment pursuant to section 300x or 300x−21 of this title, has failed to comply with a provision of law referred to in subsection (a)(1) of this section, with subsection (a)(2) of this section, or with an applicable regulation (including one prescribed to carry out subsection (a)(2) of this section), the Secretary shall notify the chief executive officer of the State and shall request the chief executive officer to secure compliance. If within a reasonable period of time, not to exceed 60 days, the chief executive officer fails or refuses to secure compliance, the Secretary may − (A) refer the matter to the Attorney General with a recommendation that an appropriate civil action be instituted; (B) exercise the powers and functions provided by the Age Discrimination Act of 1975 [42 U.S.C. 6101 et seq.], section 504 of the Rehabilitation Act of 1973 [29 U.S.C. 794], title IX of the Education Amendments of 1972 [20 U.S.C. 1681 et seq.], or title VI of the Civil Rights Act of 1964 [42 U.S.C. 2000d et seq.], as may be applicable; or

197

(C) take such other actions as may be authorized by law. (2) Authority of Attorney General When a matter is referred to the Attorney General pursuant to paragraph (1)(A), or whenever the Attorney General has reason to believe that a State or an entity is engaged in a pattern or practice in violation of a provision of law referred to in subsection (a)(1) of this section or in violation of subsection (a)(2) of this section, the Attorney General may bring a civil action in any appropriate district court of the United States for such relief as may be appropriate, including injunctive relief. −SOURCE− (July 1, 1944, ch. 373, title XIX, Sec. 1947, as added Pub. L. 102−321, title II, Sec. 203(a), July 10, 1992, 106 Stat. 407.) −REFTEXT− REFERENCES IN TEXT The Age Discrimination Act of 1975, referred to in subsecs. (a)(1) and (b)(1)(B), is title III of Pub. L. 94−135, Nov. 28, 1975, 89 Stat. 728, as amended, which is classified generally to chapter 76 (Sec. 6101 et seq.) of this title. For complete classification of this Act to the Code, see Short Title note set out under section 6101 of this title and Tables. The Education Amendments of 1972, referred to in subsecs. (a)(1) and (b)(1)(B), is Pub. L. 92−318, June 23, 1972, 86 Stat. 235, as amended. Title IX of the Act, known as the Patsy Takemoto Mink Equal Opportunity in Education Act, is classified principally to chapter 38 (Sec. 1681 et seq.) of Title 20, Education. For complete

198

classification of title IX to the Code, see Short Title note set out under section 1681 of Title 20 and Tables. The Civil Rights Act of 1964, referred to in subsecs. (a)(1) and (b)(1)(B), is Pub. L. 88−352, July 2, 1964, 78 Stat. 241, as amended. Title VI of the Act is classified generally to subchapter V (Sec. 2000d et seq.) of chapter 21 of this title. For complete classification of this Act to the Code, see Short Title note set out under section 2000a of this title and Tables. −End− −CITE− 42 USC Sec. 300x−58 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XVII − BLOCK GRANTS Part B − Block Grants Regarding Mental Health and Substance Abuse subpart iii − general provisions −HEAD− Sec. 300x−58. Technical assistance and provision of supplies and services in lieu of grant funds −STATUTE− (a) Technical assistance The Secretary shall, without charge to a State receiving a grant under section 300x or 300x−21 of this title, provide to the State (or to any public or nonprofit private entity within the State) technical assistance with respect to the planning, development, and

199

operation of any program or service carried out pursuant to the program involved. The Secretary may provide such technical assistance directly, through contract, or through grants. (b) Provision of supplies and services in lieu of grant funds (1) In general Upon the request of a State receiving a grant under section 300x or 300x−21 of this title, the Secretary may, subject to paragraph (2), provide supplies, equipment, and services for the purpose of aiding the State in carrying out the program involved and, for such purpose, may detail to the State any officer or employee of the Department of Health and Human Services. (2) Corresponding reduction in payments With respect to a request described in paragraph (1), the Secretary shall reduce the amount of payments under the program involved to the State by an amount equal to the costs of detailing personnel and the fair market value of any supplies, equipment, or services provided by the Secretary. The Secretary shall, for the payment of expenses incurred in complying with such request, expend the amounts withheld. −SOURCE− (July 1, 1944, ch. 373, title XIX, Sec. 1948, as added Pub. L. 102−321, title II, Sec. 203(a), July 10, 1992, 106 Stat. 408.) −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in sections 300x−9, 300x−35 of this title.

200

−End− −CITE− 42 USC Sec. 300x−59 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XVII − BLOCK GRANTS Part B − Block Grants Regarding Mental Health and Substance Abuse subpart iii − general provisions −HEAD− Sec. 300x−59. Plans for performance partnerships −STATUTE− (a) Development The Secretary in conjunction with States and other interested groups shall develop separate plans for the programs authorized under subparts I and II for creating more flexibility for States and accountability based on outcome and other performance measures. The plans shall each include − (1) a description of the flexibility that would be given to the States under the plan; (2) the common set of performance measures that would be used for accountability, including measures that would be used for the program under subpart II for pregnant addicts, HIV transmission, tuberculosis, and those with a co−occurring substance abuse and mental disorders, and for programs under subpart I for children with serious emotional disturbance and adults with serious mental

201

illness and for individuals with co−occurring mental health and substance abuse disorders; (3) the definitions for the data elements to be used under the plan; (4) the obstacles to implementation of the plan and the manner in which such obstacles would be resolved; (5) the resources needed to implement the performance partnerships under the plan; and (6) an implementation strategy complete with recommendations for any necessary legislation. (b) Submission Not later than 2 years after October 17, 2000, the plans developed under subsection (a) of this section shall be submitted to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Commerce of the House of Representatives. (c) Information As the elements of the plans described in subsection (a) of this section are developed, States are encouraged to provide information to the Secretary on a voluntary basis. (d) Participants The Secretary shall include among those interested groups that participate in the development of the plan consumers of mental health or substance abuse services, providers, representatives of political divisions of States, and representatives of racial and ethnic groups including Native Americans.

202

−SOURCE− (July 1, 1944, ch. 373, title XIX, Sec. 1949, as added Pub. L. 102−321, title II, Sec. 203(a), July 10, 1992, 106 Stat. 408; amended Pub. L. 106−310, div. B, title XXXIV, Sec. 3403(a), Oct. 17, 2000, 114 Stat. 1219.) −COD− CODIFICATION October 17, 2000, referred to in subsec. (b), was in the original "the date of the enactment of this Act", which was translated as meaning the date of enactment of Pub. L. 106−310, which amended this section generally, to reflect the probable intent of Congress. −MISC1− AMENDMENTS 2000 − Pub. L. 106−310 amended section catchline and text generally. Prior to amendment, text read as follows: "Not later than January 24, 1994, the Secretary shall submit to the Committee on Energy and Commerce of the House of Representatives, and to the Committee on Labor and Human Resources of the Senate, a report on the activities of the States carried out pursuant to the programs established in sections 300x and 300x−21 of this title. Such report may include any recommendations of the Secretary for appropriate changes in legislation." −CHANGE− CHANGE OF NAME Committee on Commerce of House of Representatives changed to Committee on Energy and Commerce of House of Representatives, and

203

jurisdiction over matters relating to securities and exchanges and insurance generally transferred to Committee on Financial Services of House of Representatives by House Resolution No. 5, One Hundred Seventh Congress, Jan. 3, 2001. −End− −CITE− 42 USC Sec. 300x−60 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XVII − BLOCK GRANTS Part B − Block Grants Regarding Mental Health and Substance Abuse subpart iii − general provisions −HEAD− Sec. 300x−60. Rule of construction regarding delegation of authority to States −STATUTE− With respect to States receiving grants under section 300x or 300x−21 of this title, this part may not be construed to authorize the Secretary to delegate to the States the primary responsibility for interpreting the governing provisions of this part. −SOURCE− (July 1, 1944, ch. 373, title XIX, Sec. 1950, as added Pub. L. 102−321, title II, Sec. 203(a), July 10, 1992, 106 Stat. 408.) −End− −CITE−

204

42 USC Sec. 300x−61 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XVII − BLOCK GRANTS Part B − Block Grants Regarding Mental Health and Substance Abuse subpart iii − general provisions −HEAD− Sec. 300x−61. Solicitation of views of certain entities −STATUTE− In carrying out this part, the Secretary, as appropriate, shall solicit the views of the States and other appropriate entities. −SOURCE− (July 1, 1944, ch. 373, title XIX, Sec. 1951, as added Pub. L. 102−321, title II, Sec. 203(a), July 10, 1992, 106 Stat. 408.) −End− −CITE− 42 USC Sec. 300x−62 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XVII − BLOCK GRANTS Part B − Block Grants Regarding Mental Health and Substance Abuse subpart iii − general provisions −HEAD− Sec. 300x−62. Availability to States of grant payments

205

−STATUTE− Any amounts paid to a State for a fiscal year under section 300x or 300x−21 of this title shall be available for obligation and expenditure until the end of the fiscal year following the fiscal year for which the amounts were paid. −SOURCE− (July 1, 1944, ch. 373, title XIX, Sec. 1952, as added Pub. L. 102−321, title II, Sec. 203(a), July 10, 1992, 106 Stat. 409; amended Pub. L. 106−310, div. B, title XXXIV, Sec. 3403(b), Oct. 17, 2000, 114 Stat. 1220.) −MISC1− AMENDMENTS 2000 − Pub. L. 106−310 reenacted section catchline without change and amended text generally. Prior to amendment, text read as follows: "(a) In General. − Subject to subsection (b) of this section, any amounts paid to a State under the program involved shall be available for obligation until the end of the fiscal year for which the amounts were paid, and if obligated by the end of such year, shall remain available for expenditure until the end of the succeeding fiscal year. "(b) Exception Regarding Noncompliance of Subgrantees. − If a State has in accordance with subsection (a) of this section obligated amounts paid to the State under the program involved, in any case in which the Secretary determines that the obligation consists of a grant or contract awarded by the State, and that the

206

State has terminated or reduced the amount of such financial assistance on the basis of the failure of the recipient of the assistance to comply with the terms upon which the assistance was conditioned − "(1) the amounts involved shall be available for reobligation by the State through September 30 of the fiscal year following the fiscal year for which the amounts were paid to the State; and "(2) any of such amounts that are obligated by the State in accordance with paragraph (1) shall be available for expenditure through such date." −End− −CITE− 42 USC Sec. 300x−63 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XVII − BLOCK GRANTS Part B − Block Grants Regarding Mental Health and Substance Abuse subpart iii − general provisions −HEAD− Sec. 300x−63. Continuation of certain programs −STATUTE− (a) In general Of the amount allotted to the State of Hawaii under section 300x of this title, and the amount allotted to such State under section 300x−21 of this title, an amount equal to the proportion of Native

207

Hawaiians residing in the State to the total population of the State shall be available, respectively, for carrying out the program involved for Native Hawaiians. (b) Expenditure of amounts The amount made available under subsection (a) of this section may be expended only through contracts entered into by the State of Hawaii with public and private nonprofit organizations to enable such organizations to plan, conduct, and administer comprehensive substance abuse and treatment programs for the benefit of Native Hawaiians. In entering into contracts under this section, the State of Hawaii shall give preference to Native Hawaiian organizations and Native Hawaiian health centers. (c) Definitions For the purposes of this subsection,(!1) the terms "Native Hawaiian", "Native Hawaiian organization", and "Native Hawaiian health center" have the meaning given such terms in section 11707 of this title. −SOURCE− (July 1, 1944, ch. 373, title XIX, Sec. 1953, as added Pub. L. 102−321, title II, Sec. 203(a), July 10, 1992, 106 Stat. 409.) −FOOTNOTE− (!1) So in original. Probably should be "section,". −End− −CITE− 42 USC Sec. 300x−64 01/06/03 −EXPCITE−

208

TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XVII − BLOCK GRANTS Part B − Block Grants Regarding Mental Health and Substance Abuse subpart iii − general provisions −HEAD− Sec. 300x−64. Definitions −STATUTE− (a) Definitions for this subpart For purposes of this subpart: (1) The term "program involved" means the program of grants established in section 300x or 300x−21 of this title, or both, as indicated by whether the State involved is receiving or is applying to receive a grant under section 300x or 300x−21 of this title, or both. (2)(A) The term "funding agreement", with respect to a grant under section 300x of this title, has the meaning given such term in section 300x−8 of this title. (B) The term "funding agreement", with respect to a grant under section 300x−21 of this title, has the meaning given such term in section 300x−34 of this title. (b) Definitions for this part For purposes of this part: (1) The term "Comptroller General" means the Comptroller General of the United States. (2) The term "State", except as provided in sections

209

300x−7(c)(5) of this title and 300x−33(c)(5) of this title, means each of the several States, the District of Columbia, and each of the territories of the United States. (3) The term "territories of the United States" means each of the Commonwealth of Puerto Rico, American Samoa, Guam, the Commonwealth of the Northern Mariana Islands, the Virgin Islands, Palau, the Marshall Islands, and Micronesia. (4) The term "interim services", in the case of an individual in need of treatment for substance abuse who has been denied admission to a program of such treatment on the basis of the lack of the capacity of the program to admit the individual, means services for reducing the adverse health effects of such abuse, for promoting the health of the individual, and for reducing the risk of transmission of disease, which services are provided until the individual is admitted to such a program. −SOURCE− (July 1, 1944, ch. 373, title XIX, Sec. 1954, as added Pub. L. 102−321, title II, Sec. 203(a), July 10, 1992, 106 Stat. 409.) −End− −CITE− 42 USC Sec. 300x−65 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XVII − BLOCK GRANTS Part B − Block Grants Regarding Mental Health and Substance Abuse

210

subpart iii − general provisions −HEAD− Sec. 300x−65. Services provided by nongovernmental organizations −STATUTE− (a) Purposes The purposes of this section are − (1) to prohibit discrimination against nongovernmental organizations and certain individuals on the basis of religion in the distribution of government funds to provide substance abuse services under this subchapter and subchapter III−A of this chapter, and the receipt of services under such subchapters; and (2) to allow the organizations to accept the funds to provide the services to the individuals without impairing the religious character of the organizations or the religious freedom of the individuals. (b) Religious organizations included as nongovernmental providers (1) In general A State may administer and provide substance abuse services under any program under this subchapter or subchapter III−A of this chapter through grants, contracts, or cooperative agreements to provide assistance to beneficiaries under such subchapters with nongovernmental organizations. (2) Requirement A State that elects to utilize nongovernmental organizations as provided for under paragraph (1) shall consider, on the same basis as other nongovernmental organizations, religious

211

organizations to provide services under substance abuse programs under this subchapter or subchapter III−A of this chapter, so long as the programs under such subchapters are implemented in a manner consistent with the Establishment Clause of the first amendment to the Constitution. Neither the Federal Government nor a State or local government receiving funds under such programs shall discriminate against an organization that provides services under, or applies to provide services under, such programs, on the basis that the organization has a religious character. (c) Religious character and independence (1) In general A religious organization that provides services under any substance abuse program under this subchapter or subchapter III−A of this chapter shall retain its independence from Federal, State, and local governments, including such organization's control over the definition, development, practice, and expression of its religious beliefs. (2) Additional safeguards Neither the Federal Government nor a State or local government shall require a religious organization − (A) to alter its form of internal governance; or (B) to remove religious art, icons, scripture, or other symbols, in order to be eligible to provide services under any substance abuse program under this subchapter or subchapter III−A of this chapter.

212

(d) Employment practices (1) Substance abuse A religious organization that provides services under any substance abuse program under this subchapter or subchapter III−A of this chapter may require that its employees providing services under such program adhere to rules forbidding the use of drugs or alcohol. (2) Title VII exemption The exemption of a religious organization provided under section 702 or 703(e)(2) of the Civil Rights Act of 1964 (42 U.S.C. 2000e−1, 2000e−2(e)(2)) regarding employment practices shall not be affected by the religious organization's provision of services under, or receipt of funds from, any substance abuse program under this subchapter or subchapter III−A of this chapter. (e) Rights of beneficiaries of assistance (1) In general If an individual described in paragraph (3) has an objection to the religious character of the organization from which the individual receives, or would receive, services funded under any substance abuse program under this subchapter or subchapter III−A of this chapter, the appropriate Federal, State, or local governmental entity shall provide to such individual (if otherwise eligible for such services) within a reasonable period of time after the date of such objection, services that − (A) are from an alternative provider that is accessible to

213

the individual; and (B) have a value that is not less than the value of the services that the individual would have received from such organization. (2) Notice The appropriate Federal, State, or local governmental entity shall ensure that notice is provided to individuals described in paragraph (3) of the rights of such individuals under this section. (3) Individual described An individual described in this paragraph is an individual who receives or applies for services under any substance abuse program under this subchapter or subchapter III−A of this chapter. (f) Nondiscrimination against beneficiaries A religious organization providing services through a grant, contract, or cooperative agreement under any substance abuse program under this subchapter or subchapter III−A of this chapter shall not discriminate, in carrying out such program, against an individual described in subsection (e)(3) of this section on the basis of religion, a religious belief, a refusal to hold a religious belief, or a refusal to actively participate in a religious practice. (g) Fiscal accountability (1) In general Except as provided in paragraph (2), any religious organization

214

providing services under any substance abuse program under this subchapter or subchapter III−A of this chapter shall be subject to the same regulations as other nongovernmental organizations to account in accord with generally accepted accounting principles for the use of such funds provided under such program. (2) Limited audit Such organization shall segregate government funds provided under such substance abuse program into a separate account. Only the government funds shall be subject to audit by the government. (h) Compliance Any party that seeks to enforce such party's rights under this section may assert a civil action for injunctive relief exclusively in an appropriate Federal or State court against the entity, agency or official that allegedly commits such violation. (i) Limitations on use of funds for certain purposes No funds provided through a grant or contract to a religious organization to provide services under any substance abuse program under this subchapter or subchapter III−A of this chapter shall be expended for sectarian worship, instruction, or proselytization. (j) Effect on State and local funds If a State or local government contributes State or local funds to carry out any substance abuse program under this subchapter or subchapter III−A of this chapter, the State or local government may segregate the State or local funds from the Federal funds provided to carry out the program or may commingle the State or local funds with the Federal funds. If the State or local government commingles

215

the State or local funds, the provisions of this section shall apply to the commingled funds in the same manner, and to the same extent, as the provisions apply to the Federal funds. (k) Treatment of intermediate contractors If a nongovernmental organization (referred to in this subsection as an "intermediate organization"), acting under a contract or other agreement with the Federal Government or a State or local government, is given the authority under the contract or agreement to select nongovernmental organizations to provide services under any substance abuse program under this subchapter or subchapter III−A of this chapter, the intermediate organization shall have the same duties under this section as the government but shall retain all other rights of a nongovernmental organization under this section. −SOURCE− (July 1, 1944, ch. 373, title XIX, Sec. 1955, as added Pub. L. 106−310, div. B, title XXXIII, Sec. 3305, Oct. 17, 2000, 114 Stat. 1212.) −End− −CITE− 42 USC Sec. 300x−66 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XVII − BLOCK GRANTS Part B − Block Grants Regarding Mental Health and Substance Abuse

216

subpart iii − general provisions −HEAD− Sec. 300x−66. Services for individuals with co−occurring disorders −STATUTE− States may use funds available for treatment under sections 300x and 300x−21 of this title to treat persons with co−occurring substance abuse and mental disorders as long as funds available under such sections are used for the purposes for which they were authorized by law and can be tracked for accounting purposes. −SOURCE− (July 1, 1944, ch. 373, title XIX, Sec. 1956, as added Pub. L. 106−310, div. B, title XXXIV, Sec. 3407, Oct. 17, 2000, 114 Stat. 1222.) −End− −CITE− 42 USC Part C − Certain Programs Regarding Mental Health and Substance Abuse 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XVII − BLOCK GRANTS Part C − Certain Programs Regarding Mental Health and Substance Abuse −HEAD− PART C − CERTAIN PROGRAMS REGARDING MENTAL HEALTH AND SUBSTANCE ABUSE

217

−MISC1− AMENDMENTS 2000 − Pub. L. 106−310, div. B, title XXXIV, Sec. 3404(1), Oct. 17, 2000, 114 Stat. 1220, added part C heading and struck out former part C heading "Certain Programs Regarding Substance Abuse". −End− −CITE− 42 USC subpart i − data infrastructure development 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XVII − BLOCK GRANTS Part C − Certain Programs Regarding Mental Health and Substance Abuse subpart i − data infrastructure development −HEAD− SUBPART I − DATA INFRASTRUCTURE DEVELOPMENT −MISC1− AMENDMENTS 2000 − Pub. L. 106−310, div. B, title XXXIV, Sec. 3404(1), Oct. 17, 2000, 114 Stat. 1220, added subpart I heading and struck out former subpart I heading "Expansion of Capacity for Providing Treatment". −End− −CITE− 42 USC Sec. 300y 01/06/03

218

−EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XVII − BLOCK GRANTS Part C − Certain Programs Regarding Mental Health and Substance Abuse subpart i − data infrastructure development −HEAD− Sec. 300y. Data infrastructure development −STATUTE− (a) In general The Secretary may make grants to, and enter into contracts or cooperative agreements with States for the purpose of developing and operating mental health or substance abuse data collection, analysis, and reporting systems with regard to performance measures including capacity, process, and outcomes measures. (b) Projects The Secretary shall establish criteria to ensure that services will be available under this section to States that have a fundamental basis for the collection, analysis, and reporting of mental health and substance abuse performance measures and States that do not have such basis. The Secretary will establish criteria for determining whether a State has a fundamental basis for the collection, analysis, and reporting of data. (c) Condition of receipt of funds As a condition of the receipt of an award under this section a

219

State shall agree to collect, analyze, and report to the Secretary within 2 years of the date of the award on a core set of performance measures to be determined by the Secretary in conjunction with the States. (d) Matching requirement (1) In general With respect to the costs of the program to be carried out under subsection (a) of this section by a State, the Secretary may make an award under such subsection only if the applicant agrees to make available (directly or through donations from public or private entities) non−Federal contributions toward such costs in an amount that is not less than 50 percent of such costs. (2) Determination of amount contributed Non−Federal contributions under paragraph (1) may be in cash or in kind, fairly evaluated, including plant, equipment, or services. Amounts provided by the Federal Government, or services assisted or subsidized to any significant extent by the Federal Government, may not be included in determining the amount of such contributions. (e) Duration of support The period during which payments may be made for a project under subsection (a) of this section may be not less than 3 years nor more than 5 years. (f) Authorization of appropriation (1) In general

220

For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2001, 2002 and 2003. (2) Allocation Of the amounts appropriated under paragraph (1) for a fiscal year, 50 percent shall be expended to support data infrastructure development for mental health and 50 percent shall be expended to support data infrastructure development for substance abuse. −SOURCE− (July 1, 1944, ch. 373, title XIX, Sec. 1971, as added Pub. L. 106−310, div. B, title XXXIV, Sec. 3404(2), Oct. 17, 2000, 114 Stat. 1220.) −MISC1− PRIOR PROVISIONS A prior section 300y, act July 1, 1944, ch. 373, title XIX, Sec. 1971, as added Pub. L. 102−321, title II, Sec. 204, July 10, 1992, 106 Stat. 410; amended Pub. L. 102−352, Sec. 2(a)(13), Aug. 26, 1992, 106 Stat. 939, related to categorical grants to States for programs regarding substance abuse, prior to repeal by Pub. L. 106−310, div. B, title XXXIV, Sec. 3404(2), Oct. 17, 2000, 114 Stat. 1220. Another prior section 300y, act July 1, 1944, ch. 373, title XIX, Sec. 1921, as added Oct. 27, 1986, Pub. L. 99−570, title IV, Sec. 4002, 100 Stat. 3207−103, related to establishment of special alcohol abuse and drug abuse programs, prior to repeal by Pub. L. 100−690, title II, Sec. 2038(1), Nov. 18, 1988, 102 Stat. 4203.

221

Another prior section 300y, act July 1, 1944, ch. 373, title XIX, Sec. 1921, as added Aug. 13, 1981, Pub. L. 97−35, title IX, Sec. 901, 95 Stat. 552, related to planning grants, prior to repeal by Pub. L. 99−280, Sec. 5, Apr. 24, 1986, 100 Stat. 400. Prior sections 300y−1 and 300y−2 were repealed by Pub. L. 100−690, title II, Sec. 2038(1), Nov. 18, 1988, 102 Stat. 4203. Section 300y−1, act July 1, 1944, ch. 373, title XIX, Sec. 1922, as added Oct. 27, 1986, Pub. L. 99−570, title IV, Sec. 4002, 100 Stat. 3207−106, related to transfer of funds to Administrator of Veterans' Affairs. Another prior section 300y−1, act July 1, 1944, ch. 373, title XIX, Sec. 1922, as added Aug. 13, 1981, Pub. L. 97−35, title IX, Sec. 901, 95 Stat. 552, authorized appropriations, prior to repeal by Pub. L. 99−280, Sec. 5, Apr. 24, 1986, 100 Stat. 400. Section 300y−2, act July 1, 1944, ch. 373, title XIX, Sec. 1923, as added Oct. 27, 1986, Pub. L. 99−570, title IV, Sec. 4002, 100 Stat. 3207−106, related to evaluation of treatment programs. Another prior section 300y−2, act July 1, 1944, ch. 373, title XIX, Sec. 1923, as added Aug. 13, 1981, Pub. L. 97−35, title IX, Sec. 901, 95 Stat. 552, provided for grants under section 254c of this title, prior to repeal by Pub. L. 99−280, Sec. 5, Apr. 24, 1986, 100 Stat. 400. Prior sections 300y−3 to 300y−10 were repealed by Pub. L. 99−280, Sec. 5, Apr. 24, 1986, 100 Stat. 400. Section 300y−3, act July 1, 1944, ch. 373, title XIX, Sec. 1924, as added Aug. 13, 1981, Pub. L. 97−35, title IX, Sec. 901, 95 Stat.

222

553, provided that allotments be based upon prior year distributions and provided for direct distributions to Indian tribes. Section 300y−4, act July 1, 1944, ch. 373, title XIX, Sec. 1925, as added Aug. 13, 1981, Pub. L. 97−35, title IX, Sec. 901, 95 Stat. 553, related to payments under allotments to States. Section 300y−5, act July 1, 1944, ch. 373, title XIX, Sec. 1926, as added Aug. 13, 1981, Pub. L. 97−35, title IX, Sec. 901, 95 Stat. 554, related to State grants to community health centers from allotments. Section 300y−6, act July 1, 1944, ch. 373, title XIX, Sec. 1927, as added Aug. 13, 1981, Pub. L. 97−35, title IX, Sec. 901, 95 Stat. 556, related to application requirements and submittal, availability for public comment, and revision of a description of intended use of funds. Section 300y−7, act July 1, 1944, ch. 373, title XIX, Sec. 1928, as added Aug. 13, 1981, Pub. L. 97−35, title IX, Sec. 901, 95 Stat. 557, related to reporting and auditing requirements. Section 300y−8, act July 1, 1944, ch. 373, title XIX, Sec. 1929, as added Aug. 13, 1981, Pub. L. 97−35, title IX, Sec. 901, 95 Stat. 558, related to withholding of funds from a State not in compliance. Section 300y−9, act July 1, 1944, ch. 373, title XIX, Sec. 1930, as added Aug. 13, 1981, Pub. L. 97−35, title IX, Sec. 901, 95 Stat. 558, related to nondiscrimination requirements. Section 300y−10, act July 1, 1944, ch. 373, title XIX, Sec. 1931,

223

as added Aug. 13, 1981, Pub. L. 97−35, title IX, Sec. 901, 95 Stat. 559, provided criminal penalty for false statements. −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in sections 290bb−32, 300x−9, 300x−35 of this title. −End− −CITE− 42 USC subpart ii − interim maintenance treatment of narcotics dependence 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XVII − BLOCK GRANTS Part C − Certain Programs Regarding Mental Health and Substance Abuse subpart ii − interim maintenance treatment of narcotics dependence −HEAD− SUBPART II − INTERIM MAINTENANCE TREATMENT OF NARCOTICS DEPENDENCE −End− −CITE− 42 USC Sec. 300y−11 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XVII − BLOCK GRANTS

224

Part C − Certain Programs Regarding Mental Health and Substance Abuse subpart ii − interim maintenance treatment of narcotics dependence −HEAD− Sec. 300y−11. Interim maintenance treatment −STATUTE− (a) Requirement regarding Secretary Subject to the following subsections of this section, for the purpose of reducing the incidence of the transmission of HIV disease pursuant to the intravenous abuse of heroin or other morphine−like drugs, the Secretary, in establishing conditions for the use of methadone in public or nonprofit private programs of treatment for dependence on such drugs, shall authorize such programs − (1) to dispense methadone for treatment purposes to individuals who − (A) meet the conditions for admission to such programs that dispense methadone as part of comprehensive treatment for such dependence; and (B) are seeking admission to such programs that so dispense methadone, but as a result of the limited capacity of the programs, will not gain such admission until 14 or more days after seeking admission to the programs; and (2) in dispensing methadone to such individuals, to provide only minimum ancillary services during the period in which the individuals are waiting for admission to programs of

225

comprehensive treatment. (b) Inapplicability of requirement in certain circumstances (1) In general The requirement established in subsection (a) of this section for the Secretary does not apply if any or all of the following conditions are met: (A) The preponderance of scientific research indicates that the risk of the transmission of HIV disease pursuant to the intravenous abuse of drugs is minimal. (B) The preponderance of scientific research indicates that the medically supervised dispensing of methadone is not an effective method of reducing the extent of dependence on heroin and other morphine−like drugs. (C) The preponderance of available data indicates that, of treatment programs that dispense methadone as part of comprehensive treatment, a substantial majority admit all individuals seeking services to the programs not later than 14 days after the individuals seek admission to the programs. (2) Evaluation by Secretary In evaluating whether any or all of the conditions described in paragraph (1) have been met, the Secretary shall consult with the National Commission on Acquired Immune Deficiency Syndrome. (c) Conditions for obtaining authorization from Secretary (1) In general In carrying out the requirement established in subsection (a) of this section, the Secretary shall, after consultation with the

226

National Commission on Acquired Immune Deficiency Syndrome, by regulation issue such conditions for treatment programs to obtain authorization from the Secretary to provide interim maintenance treatment as may be necessary to carry out the purpose described in such subsection. Such conditions shall include conditions for preventing the unauthorized use of methadone. (2) Counseling on HIV disease The regulations issued under paragraph (1) shall provide that an authorization described in such paragraph may not be issued to a treatment program unless the program provides to recipients of the treatment counseling on preventing exposure to and the transmission of HIV disease. (3) Permission of relevant State as condition of authorization The regulations issued under paragraph (1) shall provide that the Secretary may not provide an authorization described in such paragraph to any treatment program in a State unless the chief public health officer of the State has certified to the Secretary that − (A) such officer does not object to the provision of such authorizations to treatment programs in the State; and (B) the provision of interim maintenance services in the State will not reduce the capacity of comprehensive treatment programs in the State to admit individuals to the programs (relative to the date on which such officer so certifies). (4) Date certain for issuance of regulations; failure of Secretary

227

The Secretary shall issue the final rule for purposes of the regulations required in paragraph (1), and such rule shall be effective, not later than the expiration of the 180−day period beginning on July 10, 1992. If the Secretary fails to meet the requirement of the preceding sentence, the proposed rule issued on March 2, 1989, with respect to part 291 of title 21, Code of Federal Regulations (docket numbered 88N−0444; 54 Fed. Reg. 8973 et seq.) is deemed to take effect as a final rule upon the expiration of such period, and the provisions of paragraph (3) of this subsection are deemed to be incorporated into such rule. (d) Definitions For purposes of this section: (1) The term "interim maintenance services" means the provision of methadone in a treatment program under the circumstances described in paragraphs (1) and (2) of subsection (a) of this section. (2) The term "HIV disease" means infection with the etiologic agent for acquired immune deficiency syndrome. (3) The term "treatment program" means a public or nonprofit private program of treatment for dependence on heroin or other morphine−like drugs. −SOURCE− (July 1, 1944, ch. 373, title XIX, Sec. 1976, as added Pub. L. 102−321, title II, Sec. 204, July 10, 1992, 106 Stat. 412.) −MISC1− PRIOR PROVISIONS

228

A prior section 300y−11, act July 1, 1944, ch. 373, title XIX, Sec. 1932, as added Aug. 13, 1981, Pub. L. 97−35, title IX, Sec. 901, 95 Stat. 559; amended Jan. 4, 1983, Pub. L. 97−414, Sec. 8(v), 96 Stat. 2063, related to applicability of other provisions and promulgation of regulations, prior to repeal by Pub. L. 99−280, Sec. 5, Apr. 24, 1986, 100 Stat. 400. Sections 300y−21 to 300y−27 terminated Jan. 1, 1991, pursuant to section 300y−27 and were omitted from the Code. Section 300y−21, act July 1, 1944, ch. 373, title XIX, Sec. 1931, as added Nov. 4, 1988, Pub. L. 100−607, title IV, Sec. 408(a), 102 Stat. 3117, provided definitions for this part. A prior section 1931 of act July 1, 1944, ch. 373, title XIX, as added Aug. 13, 1981, Pub. L. 97−35, title IX, Sec. 901, 95 Stat. 559, provided criminal penalty for false statements and was classified to former section 300y−10 of this title, prior to repeal by Pub. L. 99−280, Sec. 5, Apr. 24, 1986, 100 Stat. 400. Section 300y−22, act July 1, 1944, ch. 373, title XIX, Sec. 1932, as added Nov. 4, 1988, Pub. L. 100−607, title IV, Sec. 408(a), 102 Stat. 3117, authorized appropriations for this part. A prior section 1932 of act July 1, 1944, ch. 373, title XIX, as added Aug. 13, 1981, Pub. L. 97−35, title IX, Sec. 901, 95 Stat. 559; amended Jan. 4, 1983, Pub. L. 97−414, Sec. 8(v), 96 Stat. 2063, related to applicability of other provisions and promulgation of regulations and was classified to former section 300y−11 of this title, prior to repeal by Pub. L. 99−280, Sec. 5, Apr. 24, 1986, 100 Stat. 400.

229

Section 300y−23, act July 1, 1944, ch. 373, title XIX, Sec. 1933, as added Nov. 4, 1988, Pub. L. 100−607, title IV, Sec. 408(a), 102 Stat. 3117, provided for allotments under this part. Section 300y−24, act July 1, 1944, ch. 373, title XIX, Sec. 1934, as added Nov. 4, 1988, Pub. L. 100−607, title IV, Sec. 408(a), 102 Stat. 3118, provided for payments under allotments to States. Section 300y−25, act July 1, 1944, ch. 373, title XIX, Sec. 1935, as added Nov. 4, 1988, Pub. L. 100−607, title IV, Sec. 408(a), 102 Stat. 3118, specified use of allotments. Section 300y−26, act July 1, 1944, ch. 373, title XIX, Sec. 1936, as added Nov. 4, 1988, Pub. L. 100−607, title IV, Sec. 408(a), 102 Stat. 3119, provided for applications, requirements of the application, and description of activities. Section 300y−27, act July 1, 1944, ch. 373, title XIX, Sec. 1937, as added Nov. 4, 1988, Pub. L. 100−607, title IV, Sec. 408(a), 102 Stat. 3120; amended Aug. 16, 1989, Pub. L. 101−93, Sec. 5(f)(1)(B), 103 Stat. 612, provided for termination of this part effective Jan. 1, 1991. EFFECTIVE DATE Section effective July 10, 1992, with programs making awards providing financial assistance in fiscal year 1993 and subsequent years effective for awards made on or after Oct. 1, 1992, see section 801(b), (d)(1) of Pub. L. 102−321, set out as an Effective Date of 1992 Amendment note under section 236 of this title. −End− −CITE−

230

42 USC SUBCHAPTER XVIII − ADOLESCENT FAMILY LIFE DEMONSTRATION PROJECTS 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XVIII − ADOLESCENT FAMILY LIFE DEMONSTRATION PROJECTS −HEAD− SUBCHAPTER XVIII − ADOLESCENT FAMILY LIFE DEMONSTRATION PROJECTS −End− −CITE− 42 USC Sec. 300z 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XVIII − ADOLESCENT FAMILY LIFE DEMONSTRATION PROJECTS −HEAD− Sec. 300z. Findings and purposes −STATUTE− (a) The Congress finds that − (1) in 1978, an estimated one million one hundred thousand teenagers became pregnant, more than five hundred thousand teenagers carried their babies to term, and over one−half of the babies born to such teenagers were born out of wedlock; (2) adolescents aged seventeen and younger accounted for more than one−half of the out of wedlock births to teenagers; (3) in a high proportion of cases, the pregnant adolescent is

231

herself the product of an unmarried parenthood during adolescence and is continuing the pattern in her own lifestyle; (4) it is estimated that approximately 80 per centum of unmarried teenagers who carry their pregnancies to term live with their families before and during their pregnancy and remain with their families after the birth of the child; (5) pregnancy and childbirth among unmarried adolescents, particularly young adolescents, often results in severe adverse health, social, and economic consequences including: a higher percentage of pregnancy and childbirth complications; a higher incidence of low birth weight babies; a higher infant mortality and morbidity; a greater likelihood that an adolescent marriage will end in divorce; a decreased likelihood of completing schooling; and higher risks of unemployment and welfare dependency; and therefore, education, training, and job research services are important for adolescent parents; (6)(A) adoption is a positive option for unmarried pregnant adolescents who are unwilling or unable to care for their children since adoption is a means of providing permanent families for such children from available approved couples who are unable or have difficulty in conceiving or carrying children of their own to term; and (B) at present, only 4 per centum of unmarried pregnant adolescents who carry their babies to term enter into an adoption plan or arrange for their babies to be cared for by relatives or friends;

232

(7) an unmarried adolescent who becomes pregnant once is likely to experience recurrent pregnancies and childbearing, with increased risks; (8)(A) the problems of adolescent premarital sexual relations, pregnancy, and parenthood are multiple and complex and are frequently associated with or are a cause of other troublesome situations in the family; and (B) such problems are best approached through a variety of integrated and essential services provided to adolescents and their families by other family members, religious and charitable organizations, voluntary associations, and other groups in the private sector as well as services provided by publicly sponsored initiatives; (9) a wide array of educational, health, and supportive services are not available to adolescents with such problems or to their families, or when available frequently are fragmented and thus are of limited effectiveness in discouraging adolescent premarital sexual relations and the consequences of such relations; (10)(A) prevention of adolescent sexual activity and adolescent pregnancy depends primarily upon developing strong family values and close family ties, and since the family is the basic social unit in which the values and attitudes of adolescents concerning sexuality and pregnancy are formed, programs designed to deal with issues of sexuality and pregnancy will be successful to the extent that such programs encourage and sustain the role of the

233

family in dealing with adolescent sexual activity and adolescent pregnancy; (B) Federal policy therefore should encourage the development of appropriate health, educational, and social services where such services are now lacking or inadequate, and the better coordination of existing services where they are available; and (C) services encouraged by the Federal Government should promote the involvement of parents with their adolescent children, and should emphasize the provision of support by other family members, religious and charitable organizations, voluntary associations, and other groups in the private sector in order to help adolescents and their families deal with complex issues of adolescent premarital sexual relations and the consequences of such relations; and (11)(A) there has been limited research concerning the societal causes and consequences of adolescent pregnancy; (B) there is limited knowledge concerning which means of intervention are effective in mediating or eliminating adolescent premarital sexual relations and adolescent pregnancy; and (C) it is necessary to expand and strengthen such knowledge in order to develop an array of approaches to solving the problems of adolescent premarital sexual relations and adolescent pregnancy in both urban and rural settings. (b) Therefore, the purposes of this subchapter are − (1) to find effective means, within the context of the family, of reaching adolescents before they become sexually active in

234

order to maximize the guidance and support available to adolescents from parents and other family members, and to promote self discipline and other prudent approaches to the problem of adolescent premarital sexual relations, including adolescent pregnancy; (2) to promote adoption as an alternative for adolescent parents; (3) to establish innovative, comprehensive, and integrated approaches to the delivery of care services both for pregnant adolescents, with primary emphasis on unmarried adolescents who are seventeen years of age or under, and for adolescent parents, which shall be based upon an assessment of existing programs and, where appropriate, upon efforts to establish better coordination, integration, and linkages among such existing programs in order to − (A) enable pregnant adolescents to obtain proper care and assist pregnant adolescents and adolescent parents to become productive independent contributors to family and community life; and (B) assist families of adolescents to understand and resolve the societal causes which are associated with adolescent pregnancy; (4) to encourage and support research projects and demonstration projects concerning the societal causes and consequences of adolescent premarital sexual relations, contraceptive use, pregnancy, and child rearing;

235

(5) to support evaluative research to identify effective services which alleviate, eliminate, or resolve any negative consequences of adolescent premarital sexual relations and adolescent childbearing for the parents, the child, and their families; and (6) to encourage and provide for the dissemination of results, findings, and information from programs and research projects relating to adolescent premarital sexual relations, pregnancy, and parenthood. −SOURCE− (July 1, 1944, ch. 373, title XX, Sec. 2001, as added Pub. L. 97−35, title IX, Sec. 955(a), Aug. 13, 1981, 95 Stat. 578; amended Pub. L. 98−512, Sec. 2(b), (c), Oct. 19, 1984, 98 Stat. 2409.) −MISC1− AMENDMENTS 1984 − Subsec. (a)(5). Pub. L. 98−512, Sec. 2(b), struck out reference relating to developmental disabilities and inserted provision relating to importance of education, training, and job research services for adolescent parents. Subsec. (b)(3). Pub. L. 98−512, Sec. 2(c), inserted "both" before "for pregnant adolescents". −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in section 300z−7 of this title. −End− −CITE−

236

42 USC Sec. 300z−1 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XVIII − ADOLESCENT FAMILY LIFE DEMONSTRATION PROJECTS −HEAD− Sec. 300z−1. Definitions; regulations applicable −STATUTE− (a) For the purposes of this subchapter, the term − (1) "Secretary" means the Secretary of Health and Human Services; (2) "eligible person" means − (A) with regard to the provision of care services, a pregnant adolescent, an adolescent parent, or the family of a pregnant adolescent or an adolescent parent; or (B) with regard to the provision of prevention services and referral to such other services which may be appropriate, a nonpregnant adolescent; (3) "eligible grant recipient" means a public or nonprofit private organization or agency which demonstrates, to the satisfaction of the Secretary − (A) in the case of an organization which will provide care services, the capability of providing all core services in a single setting or the capability of creating a network through which all core services would be provided; or (B) in the case of an organization which will provide

237

prevention services, the capability of providing such services; (4) "necessary services" means services which may be provided by grantees which are − (A) pregnancy testing and maternity counseling; (B) adoption counseling and referral services which present adoption as an option for pregnant adolescents, including referral to licensed adoption agencies in the community if the eligible grant recipient is not a licensed adoption agency; (C) primary and preventive health services including prenatal and postnatal care; (D) nutrition information and counseling; (E) referral for screening and treatment of venereal disease; (F) referral to appropriate pediatric care; (G) educational services relating to family life and problems associated with adolescent premarital sexual relations, including − (i) information about adoption; (ii) education on the responsibilities of sexuality and parenting; (iii) the development of material to support the role of parents as the provider of sex education; and (iv) assistance to parents, schools, youth agencies, and health providers to educate adolescents and preadolescents concerning self−discipline and responsibility in human sexuality; (H) appropriate educational and vocational services;

238

(I) referral to licensed residential care or maternity home services; and (J) mental health services and referral to mental health services and to other appropriate physical health services; (K) child care sufficient to enable the adolescent parent to continue education or to enter into employment; (L) consumer education and homemaking; (M) counseling for the immediate and extended family members of the eligible person; (N) transportation; (O) outreach services to families of adolescents to discourage sexual relations among unemancipated minors; (P) family planning services; and (Q) such other services consistent with the purposes of this subchapter as the Secretary may approve in accordance with regulations promulgated by the Secretary; (5) "core services" means those services which shall be provided by a grantee, as determined by the Secretary by regulation; (6) "supplemental services" means those services which may be provided by a grantee, as determined by the Secretary by regulation; (7) "care services" means necessary services for the provision of care to pregnant adolescents and adolescent parents and includes all core services with respect to the provision of such care prescribed by the Secretary by regulation;

239

(8) "prevention services" means necessary services to prevent adolescent sexual relations, including the services described in subparagraphs (A), (D), (E), (G), (H), (M), (N), (O), and (Q) of paragraph (4); (9) "adolescent" means an individual under the age of nineteen; and (10) "unemancipated minor" means a minor who is subject to the control, authority, and supervision of his or her parents or guardians, as determined under State law. (b) Until such time as the Secretary promulgates regulations pursuant to the second sentence of this subsection, the Secretary shall use the regulations promulgated under title VI of the Health Services and Centers Amendments of 1978 [42 U.S.C. 300a−21 et seq.] which were in effect on August 13, 1981, to determine which necessary services are core services for purposes of this subchapter. The Secretary may promulgate regulations to determine which necessary services are core services for purposes of this subchapter based upon an evaluation of and information concerning which necessary services are essential to carry out the purposes of this subchapter and taking into account (1) factors such as whether services are to be provided in urban or rural areas, the ethnic groups to be served, and the nature of the populations to be served, and (2) the results of the evaluations required under section 300z−5(b) of this title. The Secretary may from time to time revise such regulations. −SOURCE−

240

(July 1, 1944, ch. 373, title XX, Sec. 2002, as added Pub. L. 97−35, title IX, Sec. 955(a), Aug. 13, 1981, 95 Stat. 580; amended Pub. L. 98−512, Sec. 2(d), Oct. 19, 1984, 98 Stat. 2409.) −REFTEXT− REFERENCES IN TEXT The Health Services and Centers Amendments of 1978, referred to in subsec. (b), is Pub. L. 95−626, Nov. 10, 1978, 92 Stat. 3551, as amended. Title VI of the Health Services and Centers Amendments of 1978 was classified generally to part A (Sec. 300a−21 et seq.) of subchapter VIII−A of this chapter prior to its repeal by Pub. L. 97−35, title IX, Sec. 955(b), title XXI, Sec. 2193(f), Aug. 13, 1981, 95 Stat. 592, 828. For complete classification of this Act to the Code, see Short Title of 1978 Amendments note set out under section 201 of this title and Tables. −MISC1− AMENDMENTS 1984 − Subsec. (a)(4)(H). Pub. L. 98−512 struck out "and referral to such services" after "vocational services". −End− −CITE− 42 USC Sec. 300z−2 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XVIII − ADOLESCENT FAMILY LIFE DEMONSTRATION PROJECTS −HEAD−

241

Sec. 300z−2. Demonstration projects; grant authorization, etc. −STATUTE− (a) The Secretary may make grants to further the purposes of this subchapter to eligible grant recipients which have submitted an application which the Secretary finds meets the requirements of section 300z−5 of this title for demonstration projects which the Secretary determines will help communities provide appropriate care and prevention services in easily accessible locations. Demonstration projects shall, as appropriate, provide, supplement, or improve the quality of such services. Demonstration projects shall use such methods as will strengthen the capacity of families to deal with the sexual behavior, pregnancy, or parenthood of adolescents and to make use of support systems such as other family members, friends, religious and charitable organizations, and voluntary associations. (b) Grants under this subchapter for demonstration projects may be for the provision of − (1) care services; (2) prevention services; or (3) a combination of care services and prevention services. −SOURCE− (July 1, 1944, ch. 373, title XX, Sec. 2003, as added Pub. L. 97−35, title IX, Sec. 955(a), Aug. 13, 1981, 95 Stat. 582.) −End− −CITE− 42 USC Sec. 300z−3 01/06/03

242

−EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XVIII − ADOLESCENT FAMILY LIFE DEMONSTRATION PROJECTS −HEAD− Sec. 300z−3. Uses of grants for demonstration projects for services −STATUTE− (a) Covered projects Except as provided in subsection (b) of this section, funds provided for demonstration projects for services under this subchapter may be used by grantees only to − (1) provide to eligible persons − (A) care services; (B) prevention services; or (C) care and prevention services (in the case of a grantee who is providing a combination of care and prevention services); (2) coordinate, integrate, and provide linkages among providers of care, prevention, and other services for eligible persons in furtherance of the purposes of this subchapter; (3) provide supplemental services where such services are not adequate or not available to eligible persons in the community and which are essential to the care of pregnant adolescents and to the prevention of adolescent premarital sexual relations and adolescent pregnancy; (4) plan for the administration and coordination of pregnancy

243

prevention services and programs of care for pregnant adolescents and adolescent parents which will further the objectives of this subchapter; and (5) fulfill assurances required for grant approval by section 300z−5 of this title. (b) Family planning services; availability in community (1) No funds provided for a demonstration project for services under this subchapter may be used for the provision of family planning services (other than counseling and referral services) to adolescents unless appropriate family planning services are not otherwise available in the community. (2) Any grantee who receives funds for a demonstration project for services under this subchapter and who, after determining under paragraph (1) that appropriate family planning services are not otherwise available in the community, provides family planning services (other than counseling and referral services) to adolescents may only use funds provided under this subchapter for such family planning services if all funds received by such grantee from all other sources to support such family planning services are insufficient to support such family planning services. (c) Fees for services: criteria Grantees who receive funds for a demonstration project for services under this subchapter shall charge fees for services pursuant to a fee schedule approved by the Secretary as a part of the application described in section 300z−5 of this title which bases fees charged by the grantee on the income of the eligible

244

person or the parents or legal guardians of the eligible person and takes into account the difficulty adolescents face in obtaining resources to pay for services. A grantee who receives funds for a demonstration project for services under this subchapter may not, in any case, discriminate with regard to the provision of services to any individual because of that individual's inability to provide payment for such services, except that in determining the ability of an unemancipated minor to provide payment for services, the income of the family of an unemancipated minor shall be considered in determining the ability of such minor to make such payments unless the parents or guardians of the unemancipated minor refuse to make such payments. −SOURCE− (July 1, 1944, ch. 373, title XX, Sec. 2004, as added Pub. L. 97−35, title IX, Sec. 955(a), Aug. 13, 1981, 95 Stat. 583.) −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in section 300z−5 of this title. −End− −CITE− 42 USC Sec. 300z−4 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XVIII − ADOLESCENT FAMILY LIFE DEMONSTRATION PROJECTS −HEAD−

245

Sec. 300z−4. Grants for demonstration projects for services −STATUTE− (a) Priorities In approving applications for grants for demonstration projects for services under this subchapter, the Secretary shall give priority to applicants who − (1) serve an area where there is a high incidence of adolescent pregnancy; (2) serve an area with a high proportion of low−income families and where the availability of programs of care for pregnant adolescents and adolescent parents is low; (3) show evidence − (A) in the case of an applicant who will provide care services, of having the ability to bring together a wide range of needed core services and, as appropriate, supplemental services in comprehensive single−site projects, or to establish a well−integrated network of such services (appropriate for the target population and geographic area to be served including the special needs of rural areas) for pregnant adolescents or adolescent parents; or (B) in the case of an applicant who will provide prevention services, of having the ability to provide prevention services for adolescents and their families which are appropriate for the target population and the geographic area to be served, including the special needs of rural areas; (4) will utilize to the maximum extent feasible existing

246

available programs and facilities such as neighborhood and primary health care centers, maternity homes which provide or can be equipped to provide services to pregnant adolescents, agencies serving families, youth, and children with established programs of service to pregnant adolescents and vulnerable families, licensed adoption agencies, children and youth centers, maternal and infant health centers, regional rural health facilities, school and other educational programs, mental health programs, nutrition programs, recreation programs, and other ongoing pregnancy prevention services and programs of care for pregnant adolescents and adolescent parents; (5) make use, to the maximum extent feasible, of other Federal, State, and local funds, programs, contributions, and other third−party reimbursements; (6) can demonstrate a community commitment to the program by making available to the demonstration project non−Federal funds, personnel, and facilities; (7) have involved the community to be served, including public and private agencies, adolescents, and families, in the planning and implementation of the demonstration project; and (8) will demonstrate innovative and effective approaches in addressing the problems of adolescent premarital sexual relations, pregnancy, or parenthood, including approaches to provide pregnant adolescents with adequate information about adoption. (b) Factors to be considered in making grants; special needs of

247

rural areas (1) The amount of a grant for a demonstration project for services under this subchapter shall be determined by the Secretary, based on factors such as the incidence of adolescent pregnancy in the geographic area to be served, and the adequacy of pregnancy prevention services and programs of care for pregnant adolescents and adolescent parents in such area. (2) In making grants for demonstration projects for services under this subchapter, the Secretary shall consider the special needs of rural areas and, to the maximum extent practicable, shall distribute funds taking into consideration the relative number of adolescents in such areas in need of such services. (c) Duration; Federal share (1) A grantee may not receive funds for a demonstration project for services under this subchapter for a period in excess of 5 years. (2)(A) Subject to paragraph (3), a grant for a demonstration project for services under this subchapter may not exceed − (i) 70 per centum of the costs of the project for the first and second years of the project; (ii) 60 per centum of such costs for the third year of the project; (iii) 50 per centum of such costs for the fourth year of the project; and (iv) 40 per centum of such costs for the fifth year of the project.

248

(B) Non−Federal contributions required by subparagraph (A) may be in cash or in kind, fairly evaluated, including plant, equipment, or services. (3) The Secretary may waive the limitation specified in paragraph (2)(A) for any year in accordance with criteria established by regulation. −SOURCE− (July 1, 1944, ch. 373, title XX, Sec. 2005, as added Pub. L. 97−35, title IX, Sec. 955(a), Aug. 13, 1981, 95 Stat. 584.) −End− −CITE− 42 USC Sec. 300z−5 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XVIII − ADOLESCENT FAMILY LIFE DEMONSTRATION PROJECTS −HEAD− Sec. 300z−5. Requirements for applications −STATUTE− (a) Form, content, and assurances An application for a grant for a demonstration project for services under this subchapter shall be in such form and contain such information as the Secretary may require, and shall include − (1) an identification of the incidence of adolescent pregnancy and related problems; (2) a description of the economic conditions and income levels

249

in the geographic area to be served; (3) a description of existing pregnancy prevention services and programs of care for pregnant adolescents and adolescent parents (including adoption services), and including where, how, by whom, and to which population groups such services are provided, and the extent to which they are coordinated in the geographic area to be served; (4) a description of the major unmet needs for services for adolescents at risk of initial or recurrent pregnancies and an estimate of the number of adolescents not being served in the area; (5)(A) in the case of an applicant who will provide care services, a description of how all core services will be provided in the demonstration project using funds under this subchapter or will otherwise be provided by the grantee in the area to be served, the population to which such services will be provided, how such services will be coordinated, integrated, and linked with other related programs and services and the source or sources of funding of such core services in the public and private sectors; or (B) in the case of an applicant who will provide prevention services, a description of the necessary services to be provided and how the applicant will provide such services; (6) a description of the manner in which adolescents needing services other than the services provided directly by the applicant will be identified and how access and appropriate

250

referral to such other services (such as medicaid; licensed adoption agencies; maternity home services; public assistance; employment services; child care services for adolescent parents; and other city, county, and State programs related to adolescent pregnancy) will be provided, including a description of a plan to coordinate such other services with the services supported under this subchapter; (7) a description of the applicant's capacity to continue services as Federal funds decrease and in the absence of Federal assistance; (8) a description of the results expected from the provision of services, and the procedures to be used for evaluating those results; (9) a summary of the views of public agencies, providers of services, and the general public in the geographic area to be served, concerning the proposed use of funds provided for a demonstration project for services under this subchapter and a description of procedures used to obtain those views, and, in the case of applicants who propose to coordinate services administered by a State, the written comments of the appropriate State officials responsible for such services; (10) assurances that the applicant will have an ongoing quality assurance program; (11) assurances that, where appropriate, the applicant shall have a system for maintaining the confidentiality of patient records in accordance with regulations promulgated by the

251

Secretary; (12) assurances that the applicant will demonstrate its financial responsibility by the use of such accounting procedures and other requirements as may be prescribed by the Secretary; (13) assurances that the applicant (A) has or will have a contractual or other arrangement with the agency of the State (in which the applicant provides services) that administers or supervises the administration of a State plan approved under title XIX of the Social Security Act [42 U.S.C. 1396 et seq.] for the payment of all or a part of the applicant's costs in providing health services to persons who are eligible for medical assistance under such a State plan, or (B) has made or will make every reasonable effort to enter into such an arrangement; (14) assurances that the applicant has made or will make and will continue to make every reasonable effort to collect appropriate reimbursement for its costs in providing health services to persons who are entitled to benefits under title V of the Social Security Act [42 U.S.C. 701 et seq.], to medical assistance under a State plan approved under title XIX of such Act [42 U.S.C. 1396 et seq.], or to assistance for medical expenses under any other public assistance program or private health insurance program; (15) assurances that the applicant has or will make and will continue to make every reasonable effort to collect appropriate reimbursement for its costs in providing services to persons entitled to services under parts B and E of title IV [42 U.S.C.

252

620 et seq., 670 et seq.] and title XX of the Social Security Act [42 U.S.C. 1397 et seq.]; (16)(A) a description of − (i) the schedule of fees to be used in the provision of services, which shall comply with section 300z−3(c) of this title and which shall be designed to cover all reasonable direct and indirect costs incurred by the applicant in providing services; and (ii) a corresponding schedule of discounts to be applied to the payment of such fees, which shall comply with section 300z−3(c) of this title and which shall be adjusted on the basis of the ability of the eligible person to pay; (B) assurances that the applicant has made and will continue to make every reasonable effort − (i) to secure from eligible persons payment for services in accordance with such schedules; (ii) to collect reimbursement for health or other services provided to persons who are entitled to have payment made on their behalf for such services under any Federal or other government program or private insurance program; and (iii) to seek such reimbursement on the basis of the full amount of fees for services without application of any discount; and (C) assurances that the applicant has submitted or will submit to the Secretary such reports as the Secretary may require to determine compliance with this paragraph;

253

(17) assurances that the applicant will make maximum use of funds available under subchapter VIII of this chapter; (18) assurances that the acceptance by any individual of family planning services or family planning information (including educational materials) provided through financial assistance under this subchapter shall be voluntary and shall not be a prerequisite to eligibility for or receipt of any other service furnished by the applicant; (19) assurances that fees collected by the applicant for services rendered in accordance with this subchapter shall be used by the applicant to further the purposes of this subchapter; (20) assurances that the applicant, if providing both prevention and care services will not exclude or discriminate against any adolescent who receives prevention services and subsequently requires care services as a pregnant adolescent; (21) a description of how the applicant will, as appropriate in the provision of services − (A) involve families of adolescents in a manner which will maximize the role of the family in the solution of problems relating to the parenthood or pregnancy of the adolescent; (B) involve religious and charitable organizations, voluntary associations, and other groups in the private sector as well as services provided by publicly sponsored initiatives; (22)(A) assurances that − (i) except as provided in subparagraph (B) and subject to clause (ii), the applicant will notify the parents or guardians

254

of any unemancipated minor requesting services from the applicant and, except as provided in subparagraph (C), will obtain the permission of such parents or guardians with respect to the provision of such services; and (ii) in the case of a pregnant unemancipated minor requesting services from the applicant, the applicant will notify the parents or guardians of such minor under clause (i) within a reasonable period of time; (B) assurances that the applicant will not notify or request the permission of the parents or guardian of any unemancipated minor without the consent of the minor − (i) who solely is requesting from the applicant pregnancy testing or testing or treatment for venereal disease; (ii) who is the victim of incest involving a parent; or (iii) if an adult sibling of the minor or an adult aunt, uncle, or grandparent who is related to the minor by blood certifies to the grantee that notification of the parents or guardians of such minor would result in physical injury to such minor; and (C) assurances that the applicant will not require, with respect to the provision of services, the permission of the parents or guardians of any pregnant unemancipated minor if such parents or guardians are attempting to compel such minor to have an abortion; (23) assurances that primary emphasis for services supported under this subchapter shall be given to adolescents seventeen and

255

under who are not able to obtain needed assistance through other means; (24) assurances that funds received under this subchapter shall supplement and not supplant funds received from any other Federal, State, or local program or any private sources of funds; and (25) a plan for the conduct of, and assurances that the applicant will conduct, evaluations of the effectiveness of the services supported under this subchapter in accordance with subsection (b) of this section. (b) Evaluations: amount, conduct, and technical assistance (1) Each grantee which receives funds for a demonstration project for services under this subchapter shall expend at least 1 per centum but not in excess of 5 per centum of the amounts received under this subchapter for the conduct of evaluations of the services supported under this subchapter. The Secretary may, for a particular grantee upon good cause shown, waive the provisions of the preceding sentence with respect to the amounts to be expended on evaluations, but may not waive the requirement that such evaluations be conducted. (2) Evaluations required by paragraph (1) shall be conducted by an organization or entity which is independent of the grantee providing services supported under this subchapter. To assist in conducting the evaluations required by paragraph (1), each grantee shall develop a working relationship with a college or university located in the grantee's State which will provide or assist in

256

providing monitoring and evaluation of services supported under this subchapter unless no college or university in the grantee's State is willing or has the capacity to provide or assist in providing such monitoring and assistance. (3) The Secretary may provide technical assistance with respect to the conduct of evaluations required under this subsection to any grantee which is unable to develop a working relationship with a college or university in the applicant's State for the reasons described in paragraph (2). (c) Reports Each grantee which receives funds for a demonstration project for services under this subchapter shall make such reports concerning its use of Federal funds as the Secretary may require. Reports shall include, at such times as are considered appropriate by the Secretary, the results of the evaluations of the services supported under this subchapter. (d) Notification of parents; "adult" defined (1) A grantee shall periodically notify the Secretary of the exact number of instances in which a grantee does not notify the parents or guardians of a pregnant unemancipated minor under subsection (a)(22)(B)(iii) of this section. (2) For purposes of subsection (a)(22)(B)(iii) of this section, the term "adult" means an adult as defined by State law. (e) Submission of applications to Governor; comments by Governor Each applicant shall provide the Governor of the State in which the applicant is located a copy of each application submitted to

257

the Secretary for a grant for a demonstration project for services under this subchapter. The Governor shall submit to the applicant comments on any such application within the period of sixty days beginning on the day when the Governor receives such copy. The applicant shall include the comments of the Governor with such application. (f) Availability of core services No application submitted for a grant for a demonstration project for care services under this subchapter may be approved unless the Secretary is satisfied that core services shall be available through the applicant within a reasonable time after such grant is received. −SOURCE− (July 1, 1944, ch. 373, title XX, Sec. 2006, as added Pub. L. 97−35, title IX, Sec. 955(a), Aug. 13, 1981, 95 Stat. 585.) −REFTEXT− REFERENCES IN TEXT The Social Security Act, referred to in subsec. (a)(13) to (15), is act Aug. 14, 1935, ch. 531, 49 Stat. 620, as amended. Parts B and E of title IV of the Social Security Act are classified generally to part B (Sec. 620 et seq.) and part E (Sec. 670 et seq.) of subchapter IV of chapter 7 of this title. Titles V, XIX, and XX of the Social Security Act are classified generally to subchapters V (Sec. 701 et seq.), XIX (Sec. 1396 et seq.), and XX (Sec. 1397 et seq.), respectively, of chapter 7 of this title. For complete classification of this Act to the Code, see section 1305

258

of this title and Tables. −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in sections 300z−1, 300z−2, 300z−3 of this title. −End− −CITE− 42 USC Sec. 300z−6 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XVIII − ADOLESCENT FAMILY LIFE DEMONSTRATION PROJECTS −HEAD− Sec. 300z−6. Coordination of programs −STATUTE− (a) The Secretary shall coordinate Federal policies and programs providing services relating to the prevention of adolescent sexual relations and initial and recurrent adolescent pregnancies and providing care services for pregnant adolescents. In achieving such coordination, the Secretary shall − (1) require grantees who receive funds for demonstration projects for services under this subchapter to report periodically to the Secretary concerning Federal, State, and local policies and programs that interfere with the delivery of and coordination of pregnancy prevention services and other programs of care for pregnant adolescents and adolescent parents;

259

(2) provide technical assistance to facilitate coordination by State and local recipients of Federal assistance; (3) review all programs administered by the Department of Health and Human Services which provide prevention services or care services to determine if the policies of such programs are consistent with the policies of this subchapter, consult with other departments and agencies of the Federal Government who administer programs that provide such services, and encourage such other departments and agencies to make recommendations, as appropriate, for legislation to modify such programs in order to facilitate the use of all Government programs which provide such services as a basis for delivery of more comprehensive prevention services and more comprehensive programs of care for pregnant adolescents and adolescent parents; (4) give priority in the provision of funds, where appropriate, to applicants using single or coordinated grant applications for multiple programs; and (5) give priority, where appropriate, to the provision of funds under Federal programs administered by the Secretary (other than the program established by this subchapter) to projects providing comprehensive prevention services and comprehensive programs of care for pregnant adolescents and adolescent parents. (b) Any recipient of a grant for a demonstration project for services under this subchapter shall coordinate its activities with any other recipient of such a grant which is located in the same locality.

260

−SOURCE− (July 1, 1944, ch. 373, title XX, Sec. 2007, as added Pub. L. 97−35, title IX, Sec. 955(a), Aug. 13, 1981, 95 Stat. 589.) −End− −CITE− 42 USC Sec. 300z−7 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XVIII − ADOLESCENT FAMILY LIFE DEMONSTRATION PROJECTS −HEAD− Sec. 300z−7. Research −STATUTE− (a) Grants and contracts; duration; renewal; amount (1) The Secretary may make grants and enter into contracts with public agencies or private organizations or institutions of higher education to support the research and dissemination activities described in paragraphs (4), (5), and (6) of section 300z(b) of this title. (2) The Secretary may make grants or enter into contracts under this section for a period of one year. A grant or contract under this section for a project may be renewed for four additional one−year periods, which need not be consecutive. (3) A grant or contract for any one−year period under this section may not exceed $100,000 for the direct costs of conducting research or disemination (!1) activities under this section and may

261

include such additional amounts for the indirect costs of conducting such activities as the Secretary determines appropriate. The Secretary may waive the preceding sentence with respect to a specific project if he determines that − (A) exceptional circumstances warrant such waiver and that the project will have national impact; or (B) additional amounts are necessary for the direct costs of conducting limited demonstration projects for the provision of necessary services in order to provide data for research carried out under this subchapter. (4) The amount of any grant or contract made under this section may remain available for obligation or expenditure after the close of the one−year period for which such grant or contract is made in order to assist the recipient in preparing the report required by subsection (f)(1) of this section. (b) Scope of permissible activities (1) Funds provided for research under this section may be used for descriptive or explanatory surveys, longitudinal studies, or limited demonstration projects for services that are for the purpose of increasing knowledge and understanding of the matters described in paragraphs (4) and (5) of section 300z(b) of this title. (2) Funds provided under this section may not be used for the purchase or improvement of land, or the purchase, construction, or permanent improvement (other than minor remodeling) of any building or facility.

262

(c) Applications The Secretary may not make any grant or enter into any contract to support research or dissemination activities under this section unless − (1) the Secretary has received an application for such grant or contract which is in such form and which contains such information as the Secretary may by regulation require; (2) the applicant has demonstrated that the applicant is capable of conducting one or more of the types of research or dissemination activities described in paragraph (4), (5), or (6) of section 300z(b) of this title; and (3) in the case of an application for a research project, the panel established by subsection (e)(2) of this section has determined that the project is of scientific merit. (d) Coordination with National Institutes of Health The Secretary shall, where appropriate, coordinate research and dissemination activities carried out under this section with research and dissemination activities carried out by the National Institutes of Health. (e) Review of applications for grants and contracts; establishment of review panel (1) The Secretary shall establish a system for the review of applications for grants and contracts under this section. Such system shall be substantially similar to the system for scientific peer review of the National Institutes of Health and shall meet the requirements of paragraphs (2) and (3).

263

(2) In establishing the system required by paragraph (1), the Secretary shall establish a panel to review applications under this section. Not more than 25 per centum of the members of the panel shall be physicians. The panel shall meet as often as may be necessary to facilitate the expeditious review of applications under this section, but not less than once each year. The panel shall review each project for which an application is made under this section, evaluate the scientific merit of the project, determine whether the project is of scientific merit, and make recommendations to the Secretary concerning whether the application for the project should be approved. (3) The Secretary shall make grants under this section from among the projects which the panel established by paragraph (2) has determined to be of scientific merit and may only approve an application for a project if the panel has made such determination with respect to such a project. The Secretary shall make a determination with respect to an application within one month after receiving the determinations and recommendations of such panel with respect to the application. (f) Reports (1)(A) The recipient of a grant or contract for a research project under this section shall prepare and transmit to the Secretary a report describing the results and conclusions of such research. Except as provided in subparagraph (B), such report shall be transmitted to the Secretary not later than eighteen months after the end of the year for which funds are provided under this

264

section. The recipient may utilize reprints of articles published or accepted for publication in professional journals to supplement or replace such report if the research contained in such articles was supported under this section during the year for which the report is required. (B) In the case of any research project for which assistance is provided under this section for two or more consecutive one−year periods, the recipient of such assistance shall prepare and transmit the report required by subparagraph (A) to the Secretary not later than twelve months after the end of each one−year period for which such funding is provided. (2) Recipients of grants and contracts for dissemination under this section shall submit to the Secretary such reports as the Secretary determines appropriate. −SOURCE− (July 1, 1944, ch. 373, title XX, Sec. 2008, as added Pub. L. 97−35, title IX, Sec. 955(a), Aug. 13, 1981, 95 Stat. 589; amended Pub. L. 98−512, Sec. 2(e), Oct. 19, 1984, 98 Stat. 2409.) −MISC1− AMENDMENTS 1984 − Subsec. (g). Pub. L. 98−512 struck out subsec. (g) which provided for collection of survey data used primarily for generation of national population estimates. −FOOTNOTE− (!1) So in original. Probably should be "dissemination". −End−

265

−CITE− 42 USC Sec. 300z−8 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XVIII − ADOLESCENT FAMILY LIFE DEMONSTRATION PROJECTS −HEAD− Sec. 300z−8. Evaluation and administration −STATUTE− (a) Of the funds appropriated under this subchapter, the Secretary shall reserve not less than 1 per centum and not more than 3 per centum for the evaluation of activities carried out under this subchapter. The Secretary shall submit to the appropriate committees of the Congress a summary of each evaluation conducted under this section. (b) The officer or employee of the Department of Health and Human Services designated by the Secretary to carry out the provisions of this subchapter shall report directly to the Assistant Secretary for Health with respect to the activities of such officer or employee in carrying out such provisions. −SOURCE− (July 1, 1944, ch. 373, title XX, Sec. 2009, as added Pub. L. 97−35, title IX, Sec. 955(a), Aug. 13, 1981, 95 Stat. 591.) −End− −CITE− 42 USC Sec. 300z−9 01/06/03

266

−EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XVIII − ADOLESCENT FAMILY LIFE DEMONSTRATION PROJECTS −HEAD− Sec. 300z−9. Authorization of appropriations −STATUTE− (a) For the purpose of carrying out this subchapter, there are authorized to be appropriated $30,000,000 for the fiscal year ending September 30, 1982, $30,000,000 for the fiscal year ending September 30, 1983, $30,000,000 for the fiscal year ending September 30, 1984, and $30,000,000 for the fiscal year ending September 30, 1985. (b) At least two−thirds of the amounts appropriated to carry out this subchapter shall be used to make grants for demonstration projects for services. (c) Not more than one−third of the amounts specified under subsection (b) of this section for use for grants for demonstration projects for services shall be used for grants for demonstration projects for prevention services. −SOURCE− (July 1, 1944, ch. 373, title XX, Sec. 2010, as added Pub. L. 97−35, title IX, Sec. 955(a), Aug. 13, 1981, 95 Stat. 591; amended Pub. L. 98−512, Sec. 2(a), Oct. 19, 1984, 98 Stat. 2409.) −MISC1− AMENDMENTS

267

1984 − Subsec. (a). Pub. L. 98−509 inserted provisions authorizing appropriations for fiscal year ending Sept. 30, 1985. −End− −CITE− 42 USC Sec. 300z−10 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XVIII − ADOLESCENT FAMILY LIFE DEMONSTRATION PROJECTS −HEAD− Sec. 300z−10. Restrictions −STATUTE− (a) Grants or payments may be made only to programs or projects which do not provide abortions or abortion counseling or referral, or which do not subcontract with or make any payment to any person who provides abortions or abortion counseling or referral, except that any such program or project may provide referral for abortion counseling to a pregnant adolescent if such adolescent and the parents or guardians of such adolescent request such referral; and grants may be made only to projects or programs which do not advocate, promote, or encourage abortion. (b) The Secretary shall ascertain whether programs or projects comply with subsection (a) of this section and take appropriate action if programs or projects do not comply with such subsection, including withholding of funds. −SOURCE−

268

(July 1, 1944, ch. 373, title XX, Sec. 2011, as added Pub. L. 97−35, title IX, Sec. 955(a), Aug. 13, 1981, 95 Stat. 592.) −End− −CITE− 42 USC SUBCHAPTER XIX − VACCINES 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XIX − VACCINES −HEAD− SUBCHAPTER XIX − VACCINES −MISC1− PRIOR PROVISIONS A prior subchapter XIX (Sec. 300aa et seq.), comprised of title XXI of the Public Health Service Act, act July 1, 1944, ch. 373, Secs. 2101 to 2116, was renumbered title XXIII, Secs. 2301 to 2316, of the Public Health Service Act, and transferred to subchapter XXI (Sec. 300cc et seq.) of this chapter, renumbered title XXV, Secs. 2501 to 2514, of the Public Health Service Act, and transferred to subchapter XXV (Sec. 300aaa et seq.) of this chapter, renumbered title XXVI, Secs. 2601 to 2614, of the Public Health Service Act, renumbered title XXVII, Secs. 2701 to 2714, of the Public Health Service Act, and renumbered title II, part B, Secs. 231 to 244, of the Public Health Service Act, and transferred to part B (Sec. 238 et seq.) of subchapter I of this chapter. −SECREF−

269

SUBCHAPTER REFERRED TO IN OTHER SECTIONS This subchapter is referred to in section 283d of this title; title 26 section 9510. −End− −CITE− 42 USC Part 1 − National Vaccine Program 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XIX − VACCINES Part 1 − National Vaccine Program −HEAD− PART 1 − NATIONAL VACCINE PROGRAM −End− −CITE− 42 USC Sec. 300aa−1 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XIX − VACCINES Part 1 − National Vaccine Program −HEAD− Sec. 300aa−1. Establishment −STATUTE− The Secretary shall establish in the Department of Health and Human Services a National Vaccine Program to achieve optimal

270

prevention of human infectious diseases through immunization and to achieve optimal prevention against adverse reactions to vaccines. The Program shall be administered by a Director selected by the Secretary. −SOURCE− (July 1, 1944, ch. 373, title XXI, Sec. 2101, as added Pub. L. 99−660, title III, Sec. 311(a), Nov. 14, 1986, 100 Stat. 3756.) −MISC1− PRIOR PROVISIONS A prior section 300aa−1, act July 1, 1944, Sec. 2102, was successively renumbered by subsequent acts and transferred, see section 238a of this title. A prior section 2101 of act July 1, 1944, was successively renumbered by subsequent acts and transferred, see section 238 of this title. EFFECTIVE DATE Section 323 of title III of Pub. L. 99−660, as amended by Pub. L. 100−203, title IV, Sec. 4302(a), Dec. 22, 1987, 101 Stat. 1330−221; Pub. L. 102−168, title II, Sec. 201(a), Nov. 26, 1991, 105 Stat. 1102, provided that: "Subtitle 1 of title XXI of the Public Health Service Act [part 1 of this subchapter (42 U.S.C. 300aa−1 to 300aa−6)] shall take effect on the date of the enactment of this Act [Nov. 14, 1986] and parts A and B of subtitle 2 of such title [subparts A and B of part 2 of this subchapter (42 U.S.C. 300aa−10 to 300aa−23)] shall take effect on October 1, 1988 and parts C and D of such title [subparts C and D of part 2 of this subchapter (42

271

U.S.C. 300aa−25 to 300aa−33)] and this title [probably means provisions of title III of Pub. L. 99−660 other than those that enacted this subchapter and redesignated former sections 300aa to 300aa−15 of this title as sections 300cc to 300cc−15 of this title; these other provisions amended sections 218, 242c, 262, 286, and 289f of this title and enacted provisions set out as notes under sections 201, 300aa−1, and 300aa−4 of this title] shall take effect on the date of the enactment of the Vaccine Compensation Amendments of 1987 [Dec. 22, 1987]." SEVERABILITY Section 322 of title III of Pub. L. 99−660, as amended by Pub. L. 101−239, title VI, Sec. 6602, Dec. 19, 1989, 103 Stat. 2293; Pub. L. 101−502, Sec. 5(g)(1), Nov. 3, 1990, 104 Stat. 1288, provided that: "(a) In General. − Except as provided in subsection (b), if any provision [of] part A or B of subtitle 2 of title XXI of the Public Health Service Act [subparts A and B of part 2 of this subchapter], as added by section 311(a), or the application of such a provision to any person or circumstance is held invalid by reason of a violation of the Constitution, both such parts shall be considered invalid. "(b) Special Rule. − If any amendment made by section 6601 of the Omnibus Budget Reconciliation Act of 1989 [Pub. L. 101−239, amending sections 300aa−10 to 300aa−17, 300aa−21, 300aa−23, 300aa−26, and 300aa−27 of this title] to title XXI of the Public Health Service Act [this subchapter] or the application of such a

272

provision to any person or circumstance is held invalid by reason of the Constitution, subsection (a) shall not apply and such title XXI of the Public Health Service Act without such amendment shall continue in effect." [Amendment by section 5(g)(1) of Pub. L. 101−502 to section 322(a) of Pub. L. 99−660, set out above, effective Nov. 14, 1986, see section 5(h) of Pub. L. 101−502, set out as an Effective Date of 1990 Amendment note under section 300aa−11 of this title.] EVALUATION OF PROGRAM; STUDY AND REPORT TO CONGRESS Pub. L. 101−239, title VI, Sec. 6601(t), Dec. 19, 1989, 103 Stat. 2293, as amended by Pub. L. 102−168, title II, Sec. 201(b), Nov. 26, 1991, 105 Stat. 1103, directed the Secretary of Health and Human Services to evaluate the National Vaccine Injury Compensation Program under this subchapter and report results of such study to Committee on Energy and Commerce of House of Representatives and Committee on Labor and Human Resources of Senate not later than Jan. 1, 1993. RELATED STUDIES Section 312 of title III of Pub. L. 99−660 directed Secretary of Health and Human Services, not later than 3 years after the effective date of this title (see Effective Date note above), to conduct, through studies by the Institute of Medicine of the National Academy of Sciences or other appropriate nonprofit private groups or associations, a review of pertussis vaccines and related illnesses and conditions and MMR vaccines, vaccines containing material intended to prevent or confer immunity against measles,

273

mumps, and rubella disease, and related illnesses and conditions, make specific findings and report these findings in the Federal Register not later than 3 years after the effective date of this title, and at the same time these findings are published in the Federal Register, propose regulations as a result of such findings, and not later than 42 months after the effective date of this title, promulgate such proposed regulations with such modifications as may be necessary after opportunity for public hearing. STUDY OF OTHER VACCINE RISKS Section 313 of title III of Pub. L. 99−660 provided that: "(a) Study. − "(1) Not later than 3 years after the effective date of this title [see Effective Date note above], the Secretary shall, after consultation with the Advisory Commission on Childhood Vaccines established under section 2119 of the Public Health Service Act [section 300aa−19 of this title] − "(A) arrange for a broad study of the risks (other than the risks considered under section 102 [21 U.S.C. 382]) to children associated with each vaccine set forth in the Vaccine Injury Table under section 2114 of such Act [section 300aa−14 of this title], and "(B) establish guidelines, after notice and opportunity for public hearing and consideration of all relevant medical and scientific information, respecting the administration of such vaccines which shall include − "(i) the circumstances under which any such vaccine should

274

not be administered, "(ii) the circumstances under which administration of any such vaccine should be delayed beyond its usual time of administration, and "(iii) the groups, categories, or characteristics of potential recipients of such vaccine who may be at significantly higher risk of major adverse reactions to such vaccine than the general population of potential recipients. "(2)(A) The Secretary shall request the Institute of Medicine of the National Academy of Sciences to conduct the study required by paragraph (1) under an arrangement by which the actual expenses incurred by such Academy in conducting such study will be paid by the Secretary. "(B) If the Institute of Medicine is unwilling to conduct such study under such an arrangement, the Secretary shall enter into a similar arrangement with other appropriate nonprofit private groups or associations under which such groups or associations will conduct such study. "(C) The Institute of Medicine or other group or association conducting the study required by paragraph (1) shall conduct such studies in consultation with the Advisory Commission on Childhood Vaccines established under section 2119 of the Public Health Service Act [section 300aa−19 of this title]. "(b) Revision of Guidelines. − The Secretary shall periodically, but at least every 3 years after establishing guidelines under subsection (a), review and revise such guidelines after notice and

275

opportunity for public hearing and consideration of all relevant medical and scientific information, unless the Secretary finds that on the basis of all relevant information no revision of such guidelines is warranted and publishes such finding in the Federal Register. "(c) Factors Affecting Guidelines. − Guidelines under subsection (a) shall take into account − "(1) the risk to potential recipients of the vaccines with respect to which the guidelines are established, "(2) the medical and other characteristics of such potential recipients, and "(3) the risks to the public of not having such vaccines administered. "(d) Dissemination. − The Secretary shall widely disseminate the guidelines established under subsection (a) to − "(1) physicians and other health care providers, "(2) professional health associations, "(3) State and local governments and agencies, and "(4) other relevant entities." REVIEW OF WARNINGS, USE INSTRUCTIONS, AND PRECAUTIONARY INFORMATION Section 314 of title III of Pub. L. 99−660 directed Secretary of Health and Human Services, not later than 1 year after the effective date of this title (see Effective Date note above) and after consultation with Advisory Commission on Childhood Vaccines and with other appropriate entities, to review the warnings, use instructions, and precautionary information presently issued by

276

manufacturers of vaccines set forth in the Vaccine Injury Table set out in section 300aa−14 of this title and by rule determine whether such warnings, instructions, and information adequately warn health care providers of the nature and extent of dangers posed by such vaccines, and, if any such warning, instruction, or information is determined to be inadequate for such purpose in any respect, require at the same time that the manufacturers revise and reissue such warning, instruction, or information as expeditiously as practical, but not later than 18 months after the effective date of this title. STUDY OF IMPACT ON SUPPLY OF VACCINES Section 316 of title III of Pub. L. 99−660 provided that: "On June 30, 1987, and on June 30 of each second year thereafter, the Secretary of Health and Human Services shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Labor and Human Resources of the Senate − "(1) an assessment of the impact of the amendments made by this title [enacting this subchapter, amending sections 218, 242c, 262, 286, and 289f of this title, redesignating former sections 300aa to 300aa−15 of this title as sections 300cc to 300cc−15 of this title, and enacting provisions set out as notes under this section and sections 201 and 300aa−1 of this title] on the supply of vaccines listed in the Vaccine Injury Table under section 2114 of the Public Health Service Act [section 300aa−14 of this title], and "(2) an assessment of the ability of the administrators of

277

vaccines (including public clinics and private administrators) to provide such vaccines to children." WAIVER OF PAPERWORK REDUCTION Section 321 of title III of Pub. L. 99−660 provided that: "Chapter 35 of title 44, United States Code, shall not apply to information required for purposes of carrying out this title and implementing the amendments made by this title [enacting this subchapter, amending sections 218, 242c, 262, 286, and 289f of this title, redesignating former sections 300aa to 300aa−15 of this title as sections 300cc to 300cc−15 of this title, and enacting provisions set out as notes under sections 201, 300aa−1, and 300aa−4 of this title]." −End− −CITE− 42 USC Sec. 300aa−2 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XIX − VACCINES Part 1 − National Vaccine Program −HEAD− Sec. 300aa−2. Program responsibilities −STATUTE− (a) The Director of the Program shall have the following responsibilities: (1) Vaccine research

278

The Director of the Program shall, through the plan issued under section 300aa−3 of this title, coordinate and provide direction for research carried out in or through the National Institutes of Health, the Centers for Disease Control and Prevention, the Office of Biologics Research and Review of the Food and Drug Administration, the Department of Defense, and the Agency for International Development on means to induce human immunity against naturally occurring infectious diseases and to prevent adverse reactions to vaccines. (2) Vaccine development The Director of the Program shall, through the plan issued under section 300aa−3 of this title, coordinate and provide direction for activities carried out in or through the National Institutes of Health, the Office of Biologics Research and Review of the Food and Drug Administration, the Department of Defense, and the Agency for International Development to develop the techniques needed to produce safe and effective vaccines. (3) Safety and efficacy testing of vaccines The Director of the Program shall, through the plan issued under section 300aa−3 of this title, coordinate and provide direction for safety and efficacy testing of vaccines carried out in or through the National Institutes of Health, the Centers for Disease Control and Prevention, the Office of Biologics Research and Review of the Food and Drug Administration, the Department of Defense, and the Agency for International Development. (4) Licensing of vaccine manufacturers and vaccines

279

The Director of the Program shall, through the plan issued under section 300aa−3 of this title, coordinate and provide direction for the allocation of resources in the implementation of the licensing program under section 263a of this title. (5) Production and procurement of vaccines The Director of the Program shall, through the plan issued under section 300aa−3 of this title, ensure that the governmental and non−governmental production and procurement of safe and effective vaccines by the Public Health Service, the Department of Defense, and the Agency for International Development meet the needs of the United States population and fulfill commitments of the United States to prevent human infectious diseases in other countries. (6) Distribution and use of vaccines The Director of the Program shall, through the plan issued under section 300aa−3 of this title, coordinate and provide direction to the Centers for Disease Control and Prevention and assistance to States, localities, and health practitioners in the distribution and use of vaccines, including efforts to encourage public acceptance of immunizations and to make health practitioners and the public aware of potential adverse reactions and contraindications to vaccines. (7) Evaluating the need for and the effectiveness and adverse effects of vaccines and immunization activities The Director of the Program shall, through the plan issued under section 300aa−3 of this title, coordinate and provide

280

direction to the National Institutes of Health, the Centers for Disease Control and Prevention, the Office of Biologics Research and Review of the Food and Drug Administration, the National Center for Health Statistics, the National Center for Health Services Research and Health Care Technology Assessment, and the Health Care Financing Administration in monitoring the need for and the effectiveness and adverse effects of vaccines and immunization activities. (8) Coordinating governmental and non−governmental activities The Director of the Program shall, through the plan issued under section 300aa−3 of this title, provide for the exchange of information between Federal agencies involved in the implementation of the Program and non−governmental entities engaged in the development and production of vaccines and in vaccine research and encourage the investment of non−governmental resources complementary to the governmental activities under the Program. (9) Funding of Federal agencies The Director of the Program shall make available to Federal agencies involved in the implementation of the plan issued under section 300aa−3 of this title funds appropriated under section 300aa−6 of this title to supplement the funds otherwise available to such agencies for activities under the plan. (b) In carrying out subsection (a) of this section and in preparing the plan under section 300aa−3 of this title, the Director shall consult with all Federal agencies involved in

281

research on and development, testing, licensing, production, procurement, distribution, and use of vaccines. −SOURCE− (July 1, 1944, ch. 373, title XXI, Sec. 2102, as added Pub. L. 99−660, title III, Sec. 311(a), Nov. 14, 1986, 100 Stat. 3756; amended Pub. L. 102−531, title III, Sec. 312(d)(13), Oct. 27, 1992, 106 Stat. 3505.) −MISC1− PRIOR PROVISIONS A prior section 300aa−2, act July 1, 1944, Sec. 2103, was successively renumbered by subsequent acts and transferred, see section 238b of this title. A prior section 2102 of act July 1, 1944, was successively renumbered by subsequent acts and transferred, see section 238a of this title. AMENDMENTS 1992 − Subsec. (a)(1), (3), (6), (7). Pub. L. 102−531 substituted "Centers for Disease Control and Prevention" for "Centers for Disease Control". DEMONSTRATION PROJECTS FOR OUTREACH PROGRAMS Pub. L. 101−502, Sec. 2(b), Nov. 3, 1990, 104 Stat. 1285, provided that: "(1) In general. − The Secretary of Health and Human Services, acting through the Director of the Centers for Disease Control, may make grants to public and nonprofit private entities for the purpose of carrying out demonstration projects −

282

"(A) to provide, without charge, immunizations against vaccine−preventable diseases to children not more than 2 years of age who reside in communities whose population includes a significant number of low−income individuals; and "(B) to provide outreach services to identify such children and to inform the parents (or other guardians) of the children of the availability from the entities of the immunizations specified in subparagraph (A). "(2) Authorization of appropriations. − For the purpose of carrying out paragraph (1), there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 1991 through 1993." [Centers for Disease Control changed to Centers for Disease Control and Prevention by Pub. L. 102−531, title III, Sec. 312, Oct. 27, 1992, 106 Stat. 3504.] SUPPLY OF VACCINES Pub. L. 101−502, Sec. 3, Nov. 3, 1990, 104 Stat. 1285, provided that: "(a) In General. − The Secretary of Health and Human Services, acting through the Director of the Centers for Disease Control, shall acquire and maintain a supply of vaccines sufficient to provide vaccinations throughout a 6−month period. Any proceeds received by the Secretary from the sale of vaccines from such supply shall be available to the Secretary for the purpose of purchasing vaccines for the supply. Such proceeds shall remain available for such purpose until expended.

283

"(b) Authorization of Appropriations. − For the purpose of carrying out subsection (a), there are authorized to be appropriated $5,000,000 for fiscal year 1991, and such sums as may be necessary for each of the fiscal years 1992 through 1995." [Centers for Disease Control changed to Centers for Disease Control and Prevention by Pub. L. 102−531, title III, Sec. 312, Oct. 27, 1992, 106 Stat. 3504.] Pub. L. 100−177, title I, Sec. 110(b), Dec. 1, 1987, 101 Stat. 991, provided that: "(1) In general. − The Secretary of Health and Human Services, acting through the Director of the Centers for Disease Control, shall acquire and maintain a supply of vaccines sufficient to provide vaccinations throughout a 6−month period. "(2) Authorization of Appropriations. − There are authorized to be appropriated to carry out paragraph (1) $5,000,000 for fiscal year 1988, and such sums as may be necessary for each of the fiscal years 1989 and 1990." [Centers for Disease Control changed to Centers for Disease Control and Prevention by Pub. L. 102−531, title III, Sec. 312, Oct. 27, 1992, 106 Stat. 3504.] −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in sections 300aa−3, 300aa−5, 300aa−6 of this title. −End− −CITE−

284

42 USC Sec. 300aa−3 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XIX − VACCINES Part 1 − National Vaccine Program −HEAD− Sec. 300aa−3. Plan −STATUTE− The Director of the Program shall prepare and issue a plan for the implementation of the responsibilities of the Director under section 300aa−2 of this title. The plan shall establish priorities in research and the development, testing, licensing, production, procurement, distribution, and effective use of vaccines, describe an optimal use of resources to carry out such priorities, and describe how each of the various departments and agencies will carry out their vaccine functions in consultation and coordination with the Program and in conformity with such priorities. The first plan under this section shall be prepared not later than January 1, 1987, and shall be revised not later than January 1 of each succeeding year. −SOURCE− (July 1, 1944, ch. 373, title XXI, Sec. 2103, as added Pub. L. 99−660, title III, Sec. 311(a), Nov. 14, 1986, 100 Stat. 3757.) −MISC1− PRIOR PROVISIONS

285

A prior section 300aa−3, act July 1, 1944, Sec. 2104, which was renumbered section 2304 by Pub. L. 99−660, was transferred to section 300cc−3 of this title, prior to repeal by Pub. L. 98−621, Sec. 10(s), Nov. 8, 1984, 98 Stat. 3381. A prior section 2103 of act July 1, 1944, was successively renumbered by subsequent acts and transferred, see section 238b of this title. −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in sections 300aa−2, 300aa−5 of this title. −End− −CITE− 42 USC Sec. 300aa−4 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XIX − VACCINES Part 1 − National Vaccine Program −HEAD− Sec. 300aa−4. Repealed. Pub. L. 105−362, title VI, Sec. 601(a)(1)(H), Nov. 10, 1998, 112 Stat. 3285 −MISC1− Section, act July 1, 1944, ch. 373, title XXI, Sec. 2104, as added Pub. L. 99−660, title III, Sec. 311(a), Nov. 14, 1986, 100 Stat. 3757, related to national vaccine program report.

286

A prior section 300aa−4, act July 1, 1944, Sec. 2105, was repealed by Pub. L. 99−117, Sec. 12(f), Oct. 7, 1985, 99 Stat. 495. See section 300cc−4 of this title. A prior section 2104 of act July 1, 1944, was renumbered section 2304 by Pub. L. 99−660 and classified to section 300cc−3 of this title, and was repealed by Pub. L. 98−621, Sec. 10(s), Nov. 8, 1984, 98 Stat. 3381. −End− −CITE− 42 USC Sec. 300aa−5 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XIX − VACCINES Part 1 − National Vaccine Program −HEAD− Sec. 300aa−5. National Vaccine Advisory Committee −STATUTE− (a) There is established the National Vaccine Advisory Committee. The members of the Committee shall be appointed by the Director of the Program, in consultation with the National Academy of Sciences, from among individuals who are engaged in vaccine research or the manufacture of vaccines or who are physicians, members of parent organizations concerned with immunizations, or representatives of State or local health agencies or public health organizations. (b) The Committee shall −

287

(1) study and recommend ways to encourage the availability of an adequate supply of safe and effective vaccination products in the States, (2) recommend research priorities and other measures the Director of the Program should take to enhance the safety and efficacy of vaccines, (3) advise the Director of the Program in the implementation of sections 300aa−2, 300aa−3, and 300aa−4 (!1) of this title, and (4) identify annually for the Director of the Program the most important areas of government and non−government cooperation that should be considered in implementing sections 300aa−2, 300aa−3, and 300aa−4 (!1) of this title. −SOURCE− (July 1, 1944, ch. 373, title XXI, Sec. 2105, as added Pub. L. 99−660, title III, Sec. 311(a), Nov. 14, 1986, 100 Stat. 3758.) −REFTEXT− REFERENCES IN TEXT Section 300aa−4 of this title, referred to in subsec. (b)(3), (4), was repealed by Pub. L. 105−362, title VI, Sec. 601(a)(1)(H), Nov. 10, 1998, 112 Stat. 3285. −MISC1− PRIOR PROVISIONS A prior section 300aa−5, act July 1, 1944, Sec. 2106, was successively renumbered by subsequent acts and transferred, see section 238c of this title. A prior section 2105 of act July 1, 1944, was repealed by Pub. L.

288

99−117, Sec. 12(f), Oct. 7, 1985, 99 Stat. 495. See section 300cc−4 of this title. TERMINATION OF ADVISORY COMMITTEES Advisory committees established after Jan. 5, 1973, to terminate not later than the expiration of the 2−year period beginning on the date of their establishment, unless, in the case of a committee established by the President or an officer of the Federal Government, such committee is renewed by appropriate action prior to the expiration of such 2−year period, or in the case of a committee established by the Congress, its duration is otherwise provided by law. See section 14 of Pub. L. 92−463, Oct. 6, 1972, 86 Stat. 776, set out in the Appendix to Title 5, Government Organization and Employees. Pub. L. 93−641, Sec. 6, Jan. 4, 1975, 88 Stat. 2275, set out as a note under section 217a of this title, provided that an advisory committee established pursuant to the Public Health Service Act shall terminate at such time as may be specifically prescribed by an Act of Congress enacted after Jan. 4, 1975. −FOOTNOTE− (!1) See References in Text note below. −End− −CITE− 42 USC Sec. 300aa−6 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE

289

SUBCHAPTER XIX − VACCINES Part 1 − National Vaccine Program −HEAD− Sec. 300aa−6. Authorization of appropriations −STATUTE− (a) To carry out this part other than section 300aa−2(9) of this title there are authorized to be appropriated $4,000,000 for fiscal year 1991, and such sums as may be necessary for each of the fiscal years 1992 through 1995. (b) To carry out section 300aa−2(9) of this title there are authorized to be appropriated $30,000,000 for fiscal year 1991, and such sums as may be necessary for each of the fiscal years 1992 through 1995. −SOURCE− (July 1, 1944, ch. 373, title XXI, Sec. 2106, as added Pub. L. 99−660, title III, Sec. 311(a), Nov. 14, 1986, 100 Stat. 3758; amended Pub. L. 101−502, Sec. 4, Nov. 3, 1990, 104 Stat. 1286.) −MISC1− PRIOR PROVISIONS A prior section 300aa−6, act July 1, 1944, Sec. 2107, was successively renumbered by subsequent acts and transferred, see section 238d of this title. A prior section 2106 of act July 1, 1944, was successively renumbered by subsequent acts and transferred, see section 238c of this title. Prior sections 300aa−7 to 300aa−9, act July 1, 1944, Secs.

290

2108−2110, respectively, were successively renumbered by subsequent acts and transferred, see sections 238e to 238g, respectively, of this title. AMENDMENTS 1990 − Pub. L. 101−502 substituted provisions authorizing appropriations for fiscal years 1991 through 1995 for provisions authorizing appropriations for fiscal years 1987 through 1991 in subsecs. (a) and (b). −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in section 300aa−2 of this title. −End− −CITE− 42 USC Part 2 − National Vaccine Injury Compensation Program 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XIX − VACCINES Part 2 − National Vaccine Injury Compensation Program −HEAD− PART 2 − NATIONAL VACCINE INJURY COMPENSATION PROGRAM −SECREF− PART REFERRED TO IN OTHER SECTIONS This part is referred to in title 26 section 9510. −End−

291

−CITE− 42 USC subpart a − program requirements 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XIX − VACCINES Part 2 − National Vaccine Injury Compensation Program subpart a − program requirements −HEAD− SUBPART A − PROGRAM REQUIREMENTS −End− −CITE− 42 USC Sec. 300aa−10 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XIX − VACCINES Part 2 − National Vaccine Injury Compensation Program subpart a − program requirements −HEAD− Sec. 300aa−10. Establishment of program −STATUTE− (a) Program established There is established the National Vaccine Injury Compensation Program to be administered by the Secretary under which compensation may be paid for a vaccine−related injury or death.

292

(b) Attorney's obligation It shall be the ethical obligation of any attorney who is consulted by an individual with respect to a vaccine−related injury or death to advise such individual that compensation may be available under the program (!1) for such injury or death. (c) Publicity The Secretary shall undertake reasonable efforts to inform the public of the availability of the Program. −SOURCE− (July 1, 1944, ch. 373, title XXI, Sec. 2110, as added Pub. L. 99−660, title III, Sec. 311(a), Nov. 14, 1986, 100 Stat. 3758; amended Pub. L. 101−239, title VI, Sec. 6601(b), Dec. 19, 1989, 103 Stat. 2285.) −MISC1− PRIOR PROVISIONS A prior section 300aa−10, act July 1, 1944, Sec. 2111, was successively renumbered by subsequent acts and transferred, see section 238h of this title. A prior section 2110 of act July 1, 1944, was successively renumbered by subsequent acts and transferred, see section 238g of this title. AMENDMENTS 1989 − Subsec. (c). Pub. L. 101−239 added subsec. (c). EFFECTIVE DATE OF 1989 AMENDMENT Section 6601(s) of Pub. L. 101−239, as amended by Pub. L. 102−572, title IX, Sec. 902(b)(1), Oct. 29, 1992, 106 Stat. 4516,

293

provided that: "(1) Except as provided in paragraph (2), the amendments made by this section [amending this section and sections 300aa−11 to 300aa−17, 300aa−21, 300aa−23, 300aa−26, and 300aa−27 of this title] shall apply as follows: "(A) Petitions filed after the date of enactment of this section [Dec. 19, 1989] shall proceed under the National Vaccine Injury Compensation Program under title XXI of the Public Health Service Act [this subchapter] as amended by this section. "(B) Petitions currently pending in which the evidentiary record is closed shall continue to proceed under the Program in accordance with the law in effect before the date of the enactment of this section, except that if the United States Court of Federal Claims is to review the findings of fact and conclusions of law of a special master on such a petition, the court may receive further evidence in conducting such review. "(C) Petitions currently pending in which the evidentiary record is not closed shall proceed under the Program in accordance with the law as amended by this section. All pending cases which will proceed under the Program as amended by this section shall be immediately suspended for 30 days to enable the special masters and parties to prepare for proceeding under the Program as amended by this section. In determining the 240−day period prescribed by section 2112(d) of the Public Health Service Act [42 U.S.C. 300aa−12(d)], as amended by this section, or the 420−day period prescribed by section 2121(b) of such Act [42

294

U.S.C. 300aa−21(b)], as so amended, any period of suspension under the preceding sentence shall be excluded. "(2) The amendments to section 2115 of the Public Health Service Act [42 U.S.C. 300aa−15] shall apply to all pending and subsequently filed petitions." EFFECTIVE DATE Subpart effective Oct. 1, 1988, see section 323 of Pub. L. 99−660, as amended, set out as a note under section 300aa−1 of this title. −FOOTNOTE− (!1) So in original. Probably should be capitalized. −End− −CITE− 42 USC Sec. 300aa−11 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XIX − VACCINES Part 2 − National Vaccine Injury Compensation Program subpart a − program requirements −HEAD− Sec. 300aa−11. Petitions for compensation −STATUTE− (a) General rule (1) A proceeding for compensation under the Program for a vaccine−related injury or death shall be initiated by service upon

295

the Secretary and the filing of a petition containing the matter prescribed by subsection (c) of this section with the United States Court of Federal Claims. The clerk of the United States Court of Federal Claims shall immediately forward the filed petition to the chief special master for assignment to a special master under section 300aa−12(d)(1) of this title. (2)(A) No person may bring a civil action for damages in an amount greater than $1,000 or in an unspecified amount against a vaccine administrator or manufacturer in a State or Federal court for damages arising from a vaccine−related injury or death associated with the administration of a vaccine after October 1, 1988, and no such court may award damages in an amount greater than $1,000 in a civil action for damages for such a vaccine−related injury or death, unless a petition has been filed, in accordance with section 300aa−16 of this title, for compensation under the Program for such injury or death and − (i)(I) the United States Court of Federal Claims has issued a judgment under section 300aa−12 of this title on such petition, and (II) such person elects under section 300aa−21(a) of this title to file such an action, or (ii) such person elects to withdraw such petition under section 300aa−21(b) of this title or such petition is considered withdrawn under such section. (B) If a civil action which is barred under subparagraph (A) is filed in a State or Federal court, the court shall dismiss the

296

action. If a petition is filed under this section with respect to the injury or death for which such civil action was brought, the date such dismissed action was filed shall, for purposes of the limitations of actions prescribed by section 300aa−16 of this title, be considered the date the petition was filed if the petition was filed within one year of the date of the dismissal of the civil action. (3) No vaccine administrator or manufacturer may be made a party to a civil action (other than a civil action which may be brought under paragraph (2)) for damages for a vaccine−related injury or death associated with the administration of a vaccine after October 1, 1988. (4) If in a civil action brought against a vaccine administrator or manufacturer before October 1, 1988, damages were denied for a vaccine−related injury or death or if such civil action was dismissed with prejudice, the person who brought such action may file a petition under subsection (b) of this section for such injury or death. (5)(A) A plaintiff who on October 1, 1988, has pending a civil action for damages for a vaccine−related injury or death may, at any time within 2 years after October 1, 1988, or before judgment, whichever occurs first, petition to have such action dismissed without prejudice or costs and file a petition under subsection (b) of this section for such injury or death. (B) If a plaintiff has pending a civil action for damages for a vaccine−related injury or death, such person may not file a

297

petition under subsection (b) of this section for such injury or death. (6) If a person brings a civil action after November 15, 1988 (!1) for damages for a vaccine−related injury or death associated with the administration of a vaccine before November 15, 1988, such person may not file a petition under subsection (b) of this section for such injury or death. (7) If in a civil action brought against a vaccine administrator or manufacturer for a vaccine−related injury or death damages are awarded under a judgment of a court or a settlement of such action, the person who brought such action may not file a petition under subsection (b) of this section for such injury or death. (8) If on October 1, 1988, there was pending an appeal or rehearing with respect to a civil action brought against a vaccine administrator or manufacturer and if the outcome of the last appellate review of such action or the last rehearing of such action is the denial of damages for a vaccine−related injury or death, the person who brought such action may file a petition under subsection (b) of this section for such injury or death. (9) This subsection applies only to a person who has sustained a vaccine−related injury or death and who is qualified to file a petition for compensation under the Program. (10) The Clerk of the United States Claims Court (!2) is authorized to continue to receive, and forward, petitions for compensation for a vaccine−related injury or death associated with the administration of a vaccine on or after October 1, 1992.

298

(b) Petitioners (1)(A) Except as provided in subparagraph (B), any person who has sustained a vaccine−related injury, the legal representative of such person if such person is a minor or is disabled, or the legal representative of any person who died as the result of the administration of a vaccine set forth in the Vaccine Injury Table may, if the person meets the requirements of subsection (c)(1) of this section, file a petition for compensation under the Program. (B) No person may file a petition for a vaccine−related injury or death associated with a vaccine administered before October 1, 1988, if compensation has been paid under this part for 3500 petitions for such injuries or deaths. (2) Only one petition may be filed with respect to each administration of a vaccine. (c) Petition content A petition for compensation under the Program for a vaccine−related injury or death shall contain − (1) except as provided in paragraph (3), an affidavit, and supporting documentation, demonstrating that the person who suffered such injury or who died − (A) received a vaccine set forth in the Vaccine Injury Table or, if such person did not receive such a vaccine, contracted polio, directly or indirectly, from another person who received an oral polio vaccine, (B)(i) if such person received a vaccine set forth in the Vaccine Injury Table −

299

(I) received the vaccine in the United States or in its trust territories, (II) received the vaccine outside the United States or a trust territory and at the time of the vaccination such person was a citizen of the United States serving abroad as a member of the Armed Forces or otherwise as an employee of the United States or a dependent of such a citizen, or (III) received the vaccine outside the United States or a trust territory and the vaccine was manufactured by a vaccine manufacturer located in the United States and such person returned to the United States not later than 6 months after the date of the vaccination, (ii) if such person did not receive such a vaccine but contracted polio from another person who received an oral polio vaccine, was a citizen of the United States or a dependent of such a citizen, (C)(i) sustained, or had significantly aggravated, any illness, disability, injury, or condition set forth in the Vaccine Injury Table in association with the vaccine referred to in subparagraph (A) or died from the administration of such vaccine, and the first symptom or manifestation of the onset or of the significant aggravation of any such illness, disability, injury, or condition or the death occurred within the time period after vaccine administration set forth in the Vaccine Injury Table, or (ii)(I) sustained, or had significantly aggravated, any

300

illness, disability, injury, or condition not set forth in the Vaccine Injury Table but which was caused by a vaccine referred to in subparagraph (A), or (II) sustained, or had significantly aggravated, any illness, disability, injury, or condition set forth in the Vaccine Injury Table the first symptom or manifestation of the onset or significant aggravation of which did not occur within the time period set forth in the Table but which was caused by a vaccine referred to in subparagraph (A), (D)(i) suffered the residual effects or complications of such illness, disability, injury, or condition for more than 6 months after the administration of the vaccine, or (ii) died from the administration of the vaccine, or (iii) suffered such illness, disability, injury, or condition from the vaccine which resulted in inpatient hospitalization and surgical intervention, and (E) has not previously collected an award or settlement of a civil action for damages for such vaccine−related injury or death, (2) except as provided in paragraph (3), maternal prenatal and delivery records, newborn hospital records (including all physicians' and nurses' notes and test results), vaccination records associated with the vaccine allegedly causing the injury, pre− and post−injury physician or clinic records (including all relevant growth charts and test results), all post−injury inpatient and outpatient records (including all provider notes,

301

test results, and medication records), if applicable, a death certificate, and if applicable, autopsy results, and (3) an identification of any records of the type described in paragraph (1) or (2) which are unavailable to the petitioner and the reasons for their unavailability. (d) Additional information A petition may also include other available relevant medical records relating to the person who suffered such injury or who died from the administration of the vaccine. (e) Schedule The petitioner shall submit in accordance with a schedule set by the special master assigned to the petition assessments, evaluations, and prognoses and such other records and documents as are reasonably necessary for the determination of the amount of compensation to be paid to, or on behalf of, the person who suffered such injury or who died from the administration of the vaccine. −SOURCE− (July 1, 1944, ch. 373, title XXI, Sec. 2111, as added Pub. L. 99−660, title III, Sec. 311(a), Nov. 14, 1986, 100 Stat. 3758; amended Pub. L. 100−203, title IV, Secs. 4302(b), 4304(a), (b), 4306, 4307(1), (2), Dec. 22, 1987, 101 Stat. 1330−221, 1330−223, 1330−224; Pub. L. 101−239, title VI, Sec. 6601(c)(1)−(7), Dec. 19, 1989, 103 Stat. 2285, 2286; Pub. L. 101−502, Sec. 5(a), Nov. 3, 1990, 104 Stat. 1286; Pub. L. 102−168, title II, Sec. 201(h)(1), Nov. 26, 1991, 105 Stat. 1104; Pub. L. 102−572, title IX, Sec.

302

902(b)(1), Oct. 29, 1992, 106 Stat. 4516; Pub. L. 103−43, title XX, Sec. 2012, June 10, 1993, 107 Stat. 214; Pub. L. 105−277, div. C, title XV, Sec. 1502, Oct. 21, 1998, 112 Stat. 2681−741; Pub. L. 106−310, div. A, title XVII, Sec. 1701(a), Oct. 17, 2000, 114 Stat. 1151.) −COD− CODIFICATION In subsecs. (a)(2)(A), (3), (4), (5)(A), (8), and (b)(1)(B), "October 1, 1988" substituted for "the effective date of this subpart" on authority of section 323 of Pub. L. 99−660, as amended, set out as an Effective Date note under section 300aa−1 of this title. −MISC1− PRIOR PROVISIONS A prior section 300aa−11, act July 1, 1944, Sec. 2112, was successively renumbered by subsequent acts and transferred, see section 238i of this title. A prior section 2111 of act July 1, 1944, was successively renumbered by subsequent acts and transferred, see section 238h of this title. AMENDMENTS 2000 − Subsec. (c)(1)(D)(iii). Pub. L. 106−310 added cl. (iii). 1998 − Subsec. (c)(1)(D)(i). Pub. L. 105−277 struck out "and incurred unreimbursable expenses due in whole or in part to such illness, disability, injury, or condition in an amount greater than $1,000" before ", or (ii) died".

303

1993 − Subsec. (a)(10). Pub. L. 103−43 added par. (10). 1992 − Subsec. (a)(1), (2)(A)(i)(I). Pub. L. 102−572 substituted "United States Court of Federal Claims" for "United States Claims Court" wherever appearing. 1991 − Subsec. (a)(2)(A)(i), (ii). Pub. L. 102−168 realigned margins of cls. (i) and (ii). 1990 − Subsec. (a)(2)(A). Pub. L. 101−502, Sec. 5(a)(1), substituted "unless a petition has been filed, in accordance with section 300aa−16 of this title, for compensation under the Program for such injury or death and − " and cls. (i) and (ii) for "unless − "(i) a petition has been filed, in accordance with section 300aa−16 of this title, for compensation under the Program for such injury or death, "(ii) the United States Claims Court has issued a judgment under section 300aa−12 of this title on such petition, and "(iii) such person elects under section 300aa−21(a) of this title to file such an action." Subsec. (a)(5)(A). Pub. L. 101−502, Sec. 5(a)(2), struck out "without prejudice" after "without prejudice or costs". Subsec. (a)(5)(B). Pub. L. 101−502, Sec. 5(a)(3), substituted "plaintiff" for "plaintiff who". Subsec. (d). Pub. L. 101−502, Sec. 5(a)(4), struck out "(d) except as provided in paragraph (3)," before "(d) Additional information". Subsec. (e). Pub. L. 101−502, Sec. 5(a)(5), substituted "(e)

304

Schedule" for "(e)(e) Schedule". 1989 − Subsec. (a)(1). Pub. L. 101−239, Sec. 6601(c)(1), substituted "filing of a petition containing the matter prescribed in subsection (c) of this section" for "filing of a petition" and inserted at end "The clerk of the United States Claims Court shall immediately forward the filed petition to the chief special master for assignment to a special master under section 300aa−12(d)(1) of this title." Subsec. (a)(2)(A)(i). Pub. L. 101−239, Sec. 6601(c)(2), struck out "under subsection (b) of this section" after "section 300aa−16 of this title,". Subsec. (a)(5)(A). Pub. L. 101−239, Sec. 6601(c)(3)(A), substituted "petition to have such action dismissed without prejudice or costs" for "elect to withdraw such action". Subsec. (a)(5)(B). Pub. L. 101−239, Sec. 6601(c)(3)(B), substituted "has pending" for "on October 1, 1988, had pending" and struck out "does not withdraw the action under subparagraph (A)" after "vaccine−related injury or death". Subsec. (a)(6). Pub. L. 101−239, Sec. 6601(c)(4), substituted "November 15, 1988" for "the effective date of this subpart" in two places. Subsec. (a)(8). Pub. L. 101−239, Sec. 6601(c)(5), added par. (8). Former par. (8) redesignated (9). Subsec. (a)(9). Pub. L. 101−239, Sec. 6601(c)(5), (7), redesignated par. (8) as (9) and realigned margin. Subsec. (c)(1). Pub. L. 101−239, Sec. 6601(c)(6)(A), inserted

305

"except as provided in paragraph (3)," after "(1)" in introductory provisions. Subsec. (c)(2). Pub. L. 101−239, Sec. 6601(c)(6)(B), (C), added par. (2) and redesignated former par. (2) as subsec. (d). Pub. L. 101−239, Sec. 6601(c)(6)(A), inserted "except as provided in paragraph (3)," after "(2)". Subsec. (c)(3). Pub. L. 101−239, Sec. 6601(c)(6)(C), (D), added par. (3). Former par. (3) redesignated subsec. (e). Subsec. (d). Pub. L. 101−239, Sec. 6601(c)(6)(B), redesignated former subsec. (c)(2) as subsec. (d), expanded margin to full measure, inserted subsec. designation and heading, substituted "A petition may also include other available" for "all available", struck out "(including autopsy reports, if any)" after "relevant medical records", and substituted "administration of the vaccine." for "administration of the vaccine and an identification of any unavailable records known to the petitioner and the reasons for their unavailability, and". Subsec. (e). Pub. L. 101−239, Sec. 6601(c)(6)(D), redesignated former subsec. (c)(3) as subsec. (e), expanded margin to full measure, inserted subsec. designation and heading, and substituted "The petitioner shall submit in accordance with a schedule set by the special master assigned to the petition" for "appropriate". 1987 − Subsec. (a)(1). Pub. L. 100−203, Sec. 4307(1), which directed that par. (1) be amended by substituting "with the United States Claims Court" for "with the United States district court for the district in which the petitioner resides or the injury or death

306

occurred", was executed making the substitution for "with the United States district court for the district in which the petitioner resides or in which the injury or death occurred", as the probable intent of Congress. Subsec. (a)(2)(A). Pub. L. 100−203, Sec. 4306, substituted "vaccine administrator or manufacturer" for "vaccine manufacturer". Pub. L. 100−203, Sec. 4302(b)(1), substituted "effective date of this subpart" for "effective date of this part". Subsec. (a)(2)(A)(ii). Pub. L. 100−203, Sec. 4307(2), substituted "the United States Claims Court" for "a district court of the United States". Subsec. (a)(3). Pub. L. 100−203, Sec. 4306, substituted "vaccine administrator or manufacturer" for "vaccine manufacturer". Pub. L. 100−203, Sec. 4302(b)(1), substituted "effective date of this subpart" for "effective date of this part". Subsec. (a)(4). Pub. L. 100−203, Sec. 4306, substituted "vaccine administrator or manufacturer" for "vaccine manufacturer". Pub. L. 100−203, Sec. 4302(b)(1), substituted "effective date of this subpart" for "effective date of this part". Subsec. (a)(5)(A). Pub. L. 100−203, Sec. 4302(b)(2), substituted "after the effective date of this subpart" for "after the effective date of this subchapter". Pub. L. 100−203, Sec. 4302(b)(1), substituted "who on the effective date of this subpart" for "who on the effective date of this part". Subsec. (a)(5)(B). Pub. L. 100−203, Sec. 4302(b)(1), substituted

307

"effective date of this subpart" for "effective date of this part". Subsec. (a)(6). Pub. L. 100−203, Sec. 4302(b)(1), substituted "effective date of this subpart" for "effective date of this part" in two places. Subsec. (a)(7). Pub. L. 100−203, Sec. 4306, substituted "vaccine administrator or manufacturer" for "vaccine manufacturer". Subsec. (a)(8). Pub. L. 100−203, Sec. 4304(a), added par. (8). Subsec. (b)(1)(A). Pub. L. 100−203, Sec. 4304(b)(1), substituted "may, if the person meets the requirements of subsection (c)(1) of this section, file" for "may file". Subsec. (b)(1)(B). Pub. L. 100−203, Sec. 4302(b)(1), substituted "effective date of this subpart" for "effective date of this part". Subsec. (c)(1)(D). Pub. L. 100−203, Sec. 4304(b)(2), substituted "for more than 6 months" for "for more than 1 year", "and incurred" for ", (ii) incurred", and "(ii)" for "(iii)". −CHANGE− CHANGE OF NAME References to United States Claims Court deemed to refer to United States Court of Federal Claims, see section 902(b) of Pub. L. 102−572, set out as a note under section 171 of Title 28, Judiciary and Judicial Procedure. −MISC2− EFFECTIVE DATE OF 2000 AMENDMENT Pub. L. 106−310, div. A, title XVII, Sec. 1701(b), Oct. 17, 2000, 114 Stat. 1151, provided that: "The amendment made by subsection (a) [amending this section] takes effect upon the date of the

308

enactment of this Act [Oct. 17, 2000], including with respect to petitions under section 2111 of the Public Health Service Act [this section] that are pending on such date." EFFECTIVE DATE OF 1992 AMENDMENT Amendment by Pub. L. 102−572 effective Oct. 29, 1992, see section 911 of Pub. L. 102−572, set out as a note under section 171 of Title 28, Judiciary and Judicial Procedure. EFFECTIVE DATE OF 1991 AMENDMENT Section 201(i) of Pub. L. 102−168 provided that: "(1) Except as provided in paragraph (2), the amendments made by this section [amending this section and sections 300aa−12, 300aa−15, 300aa−16, 300aa−19, and 300aa−21 of this title and provisions set out as a note under section 300aa−1 of this title] shall take effect on the date of the enactment of this Act [Nov. 26, 1991]. "(2) The amendments made by subsections (d) and (f) [amending sections 300aa−12, 300aa−15, 300aa−16, and 300aa−21 of this title] shall take effect as if the amendments had been in effect on and after October 1, 1988." EFFECTIVE DATE OF 1990 AMENDMENT Section 5(h) of Pub. L. 101−502 provided that: "The amendments made by subsections (f)(1) and (g) [amending section 300aa−21 of this title and provisions set out as a note under section 300aa−1 of this title and enacting provisions set out as a note under section 300aa−12 of this title] shall take effect as of November 14, 1986, and the amendments made by subsections (a) through (e)

309

and subsection (f)(2) [amending this section and sections 300aa−12, 300aa−13, 300aa−15, 300aa−16, and 300aa−21 of this title] shall take effect as of September 30, 1990." EFFECTIVE DATE OF 1989 AMENDMENT For applicability of amendments by Pub. L. 101−239 to petitions filed after Dec. 19, 1989, petitions currently pending in which the evidentiary record is closed, and petitions currently pending in which the evidentiary record is not closed, with provision for an immediate suspension for 30 days of all pending cases, see section 6601(s)(1) of Pub. L. 101−239, set out as a note under section 300aa−10 of this title. −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in sections 300aa−12, 300aa−13, 300aa−14, 300aa−15, 300aa−16, 300aa−21, 300aa−23, 300aa−34 of this title. −FOOTNOTE− (!1) So in original. Probably should be followed by a comma. (!2) See Change of Name note below. −End− −CITE− 42 USC Sec. 300aa−12 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XIX − VACCINES

310

Part 2 − National Vaccine Injury Compensation Program subpart a − program requirements −HEAD− Sec. 300aa−12. Court jurisdiction −STATUTE− (a) General rule The United States Court of Federal Claims and the United States Court of Federal Claims special masters shall, in accordance with this section, have jurisdiction over proceedings to determine if a petitioner under section 300aa−11 of this title is entitled to compensation under the Program and the amount of such compensation. The United States Court of Federal Claims may issue and enforce such orders as the court deems necessary to assure the prompt payment of any compensation awarded. (b) Parties (1) In all proceedings brought by the filing of a petition under section 300aa−11(b) of this title, the Secretary shall be named as the respondent, shall participate, and shall be represented in accordance with section 518(a) of title 28. (2) Within 30 days after the Secretary receives service of any petition filed under section 300aa−11 of this title the Secretary shall publish notice of such petition in the Federal Register. The special master designated with respect to such petition under subsection (c) of this section shall afford all interested persons an opportunity to submit relevant, written information − (A) relating to the existence of the evidence described in

311

section 300aa−13(a)(1)(B) of this title, or (B) relating to any allegation in a petition with respect to the matters described in section 300aa−11(c)(1)(C)(ii) of this title. (c) United States Court of Federal Claims special masters (1) There is established within the United States Court of Federal Claims an office of special masters which shall consist of not more than 8 special masters. The judges of the United States Court of Federal Claims shall appoint the special masters, 1 of whom, by designation of the judges of the United States Court of Federal Claims, shall serve as chief special master. The appointment and reappointment of the special masters shall be by the concurrence of a majority of the judges of the court. (2) The chief special master and other special masters shall be subject to removal by the judges of the United States Court of Federal Claims for incompetency, misconduct, or neglect of duty or for physical or mental disability or for other good cause shown. (3) A special master's office shall be terminated if the judges of the United States Court of Federal Claims determine, upon advice of the chief special master, that the services performed by that office are no longer needed. (4) The appointment of any individual as a special master shall be for a term of 4 years, subject to termination under paragraphs (2) and (3). Individuals serving as special masters on December 19, 1989, shall serve for 4 years from the date of their original appointment, subject to termination under paragraphs (2) and (3).

312

The chief special master in office on December 19, 1989, shall continue to serve as chief special master for the balance of the master's term, subject to termination under paragraphs (2) and (3). (5) The compensation of the special masters shall be determined by the judges of the United States Court of Federal Claims, upon advice of the chief special master. The salary of the chief special master shall be the annual rate of basic pay for level IV of the Executive Schedule, as prescribed by section 5315, title 5. The salaries of the other special masters shall not exceed the annual rate of basic pay of level V of the Executive Schedule, as prescribed by section 5316, title 5. (6) The chief special master shall be responsible for the following: (A) Administering the office of special masters and their staff, providing for the efficient, expeditious, and effective handling of petitions, and performing such other duties related to the Program as may be assigned to the chief special master by a concurrence of a majority of the United States Claims Courts (!1) judges. (B) Appointing and fixing the salary and duties of such administrative staff as are necessary. Such staff shall be subject to removal for good cause by the chief special master. (C) Managing and executing all aspects of budgetary and administrative affairs affecting the special masters and their staff, subject to the rules and regulations of the Judicial Conference of the United States. The Conference rules and

313

regulations pertaining to United States magistrate judges shall be applied to the special masters. (D) Coordinating with the United States Court of Federal Claims the use of services, equipment, personnel, information, and facilities of the United States Court of Federal Claims without reimbursement. (E) Reporting annually to the Congress and the judges of the United States Court of Federal Claims on the number of petitions filed under section 300aa−11 of this title and their disposition, the dates on which the vaccine−related injuries and deaths for which the petitions were filed occurred, the types and amounts of awards, the length of time for the disposition of petitions, the cost of administering the Program, and recommendations for changes in the Program. (d) Special masters (1) Following the receipt and filing of a petition under section 300aa−11 of this title, the clerk of the United States Court of Federal Claims shall forward the petition to the chief special master who shall designate a special master to carry out the functions authorized by paragraph (3). (2) The special masters shall recommend rules to the Court of Federal Claims and, taking into account such recommended rules, the Court of Federal Claims shall promulgate rules pursuant to section 2071 of title 28. Such rules shall − (A) provide for a less−adversarial, expeditious, and informal proceeding for the resolution of petitions,

314

(B) include flexible and informal standards of admissibility of evidence, (C) include the opportunity for summary judgment, (D) include the opportunity for parties to submit arguments and evidence on the record without requiring routine use of oral presentations, cross examinations, or hearings, and (E) provide for limitations on discovery and allow the special masters to replace the usual rules of discovery in civil actions in the United States Court of Federal Claims. (3)(A) A special master to whom a petition has been assigned shall issue a decision on such petition with respect to whether compensation is to be provided under the Program and the amount of such compensation. The decision of the special master shall − (i) include findings of fact and conclusions of law, and (ii) be issued as expeditiously as practicable but not later than 240 days, exclusive of suspended time under subparagraph (C), after the date the petition was filed. The decision of the special master may be reviewed by the United States Court of Federal Claims in accordance with subsection (e) of this section. (B) In conducting a proceeding on a petition a special master − (i) may require such evidence as may be reasonable and necessary, (ii) may require the submission of such information as may be reasonable and necessary, (iii) may require the testimony of any person and the

315

production of any documents as may be reasonable and necessary, (iv) shall afford all interested persons an opportunity to submit relevant written information − (I) relating to the existence of the evidence described in section 300aa−13(a)(1)(B) of this title, or (II) relating to any allegation in a petition with respect to the matters described in section 300aa−11(c)(1)(C)(ii) of this title, and (v) may conduct such hearings as may be reasonable and necessary. There may be no discovery in a proceeding on a petition other than the discovery required by the special master. (C) In conducting a proceeding on a petition a special master shall suspend the proceedings one time for 30 days on the motion of either party. After a motion for suspension is granted, further motions for suspension by either party may be granted by the special master, if the special master determines the suspension is reasonable and necessary, for an aggregate period not to exceed 150 days. (D) If, in reviewing proceedings on petitions for vaccine−related injuries or deaths associated with the administration of vaccines before October 1, 1988, the chief special master determines that the number of filings and resultant workload place an undue burden on the parties or the special master involved in such proceedings, the chief special master may, in the interest of justice, suspend proceedings on any petition for up to 30 months (but for not more

316

than 6 months at a time) in addition to the suspension time under subparagraph (C). (4)(A) Except as provided in subparagraph (B), information submitted to a special master or the court in a proceeding on a petition may not be disclosed to a person who is not a party to the proceeding without the express written consent of the person who submitted the information. (B) A decision of a special master or the court in a proceeding shall be disclosed, except that if the decision is to include information − (i) which is trade secret or commercial or financial information which is privileged and confidential, or (ii) which are medical files and similar files the disclosure of which would constitute a clearly unwarranted invasion of privacy, and if the person who submitted such information objects to the inclusion of such information in the decision, the decision shall be disclosed without such information. (e) Action by United States Court of Federal Claims (1) Upon issuance of the special master's decision, the parties shall have 30 days to file with the clerk of the United States Court of Federal Claims a motion to have the court review the decision. If such a motion is filed, the other party shall file a response with the clerk of the United States Court of Federal Claims no later than 30 days after the filing of such motion. (2) Upon the filing of a motion under paragraph (1) with respect

317

to a petition, the United States Court of Federal Claims shall have jurisdiction to undertake a review of the record of the proceedings and may thereafter − (A) uphold the findings of fact and conclusions of law of the special master and sustain the special master's decision, (B) set aside any findings of fact or conclusion of law of the special master found to be arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law and issue its own findings of fact and conclusions of law, or (C) remand the petition to the special master for further action in accordance with the court's direction. The court shall complete its action on a petition within 120 days of the filing of a response under paragraph (1) excluding any days the petition is before a special master as a result of a remand under subparagraph (C). The court may allow not more than 90 days for remands under subparagraph (C). (3) In the absence of a motion under paragraph (1) respecting the special master's decision or if the United States Court of Federal Claims takes the action described in paragraph (2)(A) with respect to the special master's decision, the clerk of the United States Court of Federal Claims shall immediately enter judgment in accordance with the special master's decision. (f) Appeals The findings of fact and conclusions of law of the United States Court of Federal Claims on a petition shall be final determinations of the matters involved, except that the Secretary or any

318

petitioner aggrieved by the findings or conclusions of the court may obtain review of the judgment of the court in the United States court of appeals for the Federal Circuit upon petition filed within 60 days of the date of the judgment with such court of appeals within 60 days of the date of entry of the United States Claims Court's (!2) judgment with such court of appeals. (g) Notice If − (1) a special master fails to make a decision on a petition within the 240 days prescribed by subsection (d)(3)(A)(ii) of this section (excluding (A) any period of suspension under subsection (d)(3)(C) or (d)(3)(D) of this section, and (B) any days the petition is before a special master as a result of a remand under subsection (e)(2)(C) of this section), or (2) the United States Court of Federal Claims fails to enter a judgment under this section on a petition within 420 days (excluding (A) any period of suspension under subsection (d)(3)(C) or (d)(3)(D) of this section, and (B) any days the petition is before a special master as a result of a remand under subsection (e)(2)(C) of this section) after the date on which the petition was filed, the special master or court shall notify the petitioner under such petition that the petitioner may withdraw the petition under section 300aa−21(b) of this title or the petitioner may choose under section 300aa−21(b) of this title to have the petition remain before the special master or court, as the case may be.

319

−SOURCE− (July 1, 1944, ch. 373, title XXI, Sec. 2112, as added Pub. L. 99−660, title III, Sec. 311(a), Nov. 14, 1986, 100 Stat. 3761; amended Pub. L. 100−203, title IV, Secs. 4303(d)(2)(A), 4307(3), 4308(a), (b), Dec. 22, 1987, 101 Stat. 1330−222, 1330−224; Pub. L. 100−360, title IV, Sec. 411(o)(2), (3)(A), July 1, 1988, 102 Stat. 808; Pub. L. 101−239, title VI, Sec. 6601(d)−(i), Dec. 19, 1989, 103 Stat. 2286−2290; Pub. L. 101−502, Sec. 5(b), Nov. 3, 1990, 104 Stat. 1286; Pub. L. 101−650, title III, Sec. 321, Dec. 1, 1990, 104 Stat. 5117; Pub. L. 102−168, title II, Sec. 201(c), (d)(1), (h)(2), (3), Nov. 26, 1991, 105 Stat. 1103, 1104; Pub. L. 102−572, title IX, Sec. 902(b), Oct. 29, 1992, 106 Stat. 4516; Pub. L. 103−66, title XIII, Sec. 13632(c), Aug. 10, 1993, 107 Stat. 646.) −COD− CODIFICATION In subsec. (c)(4), "on December 19, 1989," substituted for "upon the date of the enactment of this subsection" and "on the date of the enactment of this subsection". In subsec. (d)(3)(D), "October 1, 1988," substituted for "the effective date of this part". −MISC1− PRIOR PROVISIONS A prior section 300aa−12, act July 1, 1944, Sec. 2113, was successively renumbered by subsequent acts and transferred, see section 238j of this title. A prior section 2112 of act July 1, 1944, was successively

320

renumbered by subsequent acts and transferred, see section 238i of this title. AMENDMENTS 1993 − Subsec. (d)(3)(D). Pub. L. 103−66 substituted "30 months (but for not more than 6 months at a time)" for "540 days". 1992 − Subsecs. (a), (c) to (g). Pub. L. 102−572 substituted "United States Court of Federal Claims" for "United States Claims Court" and "Court of Federal Claims" for "Claims Court", wherever appearing. 1991 − Subsec. (d)(3)(D). Pub. L. 102−168, Sec. 201(c), (h)(2), realigned margin and substituted "540 days" for "180 days". Subsec. (g). Pub. L. 102−168, Sec. 201(h)(3), made technical amendment to underlying provisions of original Act. Pub. L. 102−168, Sec. 201(d)(1), substituted "or the petitioner may choose under section 300aa−21(b) of this title to have the petition remain before the special master or court, as the case may be" for "and the petition will be considered withdrawn under such section if the petitioner, the special master, or the court do not take certain actions" before period at end. 1990 − Subsec. (d)(3)(D). Pub. L. 101−502, Sec. 5(b)(1), added subpar. (D). Subsec. (g). Pub. L. 101−502, Sec. 5(b)(2), added subsec. (g). 1989 − Subsec. (a). Pub. L. 101−239, Sec. 6601(d), substituted "and the United States Claims Court special masters shall, in accordance with this section, have jurisdiction" for "shall have jurisdiction (1)", ". The United States Claims Court may issue" for

321

", and (2) to issue", and "deems" for "deem". Subsec. (b)(1). Pub. L. 101−239, Sec. 6601(f), substituted "In all proceedings brought by the filing of a petition under section 300aa−11(b) of this title, the Secretary shall be named as the respondent, shall participate, and shall be represented in accordance with section 518(a) of title 28." for "The Secretary shall be named as the respondent in all proceedings brought by the filing of a petition under section 300aa−11(b) of this title. Except as provided in paragraph (2), no other person may intervene in any such proceeding." Subsec. (c). Pub. L. 101−239, Sec. 6601(e)(2), added subsec. (c). Former subsec. (c) redesignated (d). Subsec. (d). Pub. L. 101−239, Sec. 6601(e)(1), redesignated subsec. (c) as (d). Former subsec. (d) redesignated (e). Subsec. (d)(1). Pub. L. 101−239, Sec. 6601(g)(1), amended par. (1) generally. Prior to amendment, par. (1) read as follows: "Following receipt of a petition under subsection (a) of this section, the United States Claims Court shall designate a special master to carry out the functions authorized by paragraph (2)." Subsec. (d)(2) to (4). Pub. L. 101−239, Sec. 6601(g)(2), added pars. (2) to (4) and struck out former par. (2) which prescribed functions of special masters. Subsec. (e). Pub. L. 101−239, Sec. 6601(h), substituted "Action by United States Claims Court" for "Action by court" as heading and amended text generally. Prior to amendment, text read as follows: "(1) Upon objection by the petitioner or respondent to the

322

proposed findings of fact or conclusions of law prepared by the special master or upon the court's own motion, the court shall undertake a review of the record of the proceedings and may thereafter make a de novo determination of any matter and issue its judgment accordingly, including findings of fact and conclusions of law, or remand for further proceedings. "(2) If no objection is filed under paragraph (1) or if the court does not choose to review the proceeding, the court shall adopt the proposed findings of fact and conclusions of law of the special master as its own and render judgment thereon. "(3) The court shall render its judgment on any petition filed under the Program as expeditiously as practicable but not later than 365 days after the date on which the petition was filed." Pub. L. 101−239, Sec. 6601(e)(1), redesignated subsec. (d) as (e). Former subsec. (e) redesignated (f). Subsec. (f). Pub. L. 101−239, Sec. 6601(i), inserted "within 60 days of the date of entry of the United States Claims Court's judgment with such court of appeals" after "with such court of appeals". Pub. L. 101−239, Sec. 6601(e)(1), redesignated subsec. (e) as (f). 1988 − Subsec. (c)(2). Pub. L. 100−360, Sec. 411(o)(3)(A), added Pub. L. 100−203, Sec. 4308(a), see 1987 Amendment note below. Subsec. (e). Pub. L. 100−360, Sec. 411(o)(2), made technical amendment to directory language of Pub. L. 100−203, Sec. 4307(3)(C), see 1987 Amendment note below.

323

Pub. L. 100−360, Sec. 411(o)(3)(A), added Pub. L. 100−203, Sec. 4308(b), see 1987 Amendment note below. 1987 − Subsec. (a). Pub. L. 100−203, Sec. 4307(3)(A), substituted "United States Claims Court" for "district courts of the United States" and "the court" for "the courts". Subsec. (c)(1). Pub. L. 100−203, Sec. 4307(3)(B), substituted "the United States Claims Court" for "the district court of the United States in which the petition is filed". Subsec. (c)(2). Pub. L. 100−203, Sec. 4308(a), as added by Pub. L. 100−360, Sec. 411(o)(3)(A), inserted ", shall prepare and submit to the court proposed findings of fact and conclusions of law," in introductory provisions and struck out subpar. (E) which read as follows: "prepare and submit to the court proposed findings of fact and conclusions of law." Subsec. (e). Pub. L. 100−203, Sec. 4308(b), as added by Pub. L. 100−360, Sec. 411(o)(3)(A), inserted "within 60 days of the date of the judgment" after "petition filed". Pub. L. 100−203, Sec. 4307(3)(C), as amended by Pub. L. 100−360, Sec. 411(o)(2), substituted "the United States Claims Court" for "a district court of the United States" and "for the Federal Circuit" for "for the circuit in which the court is located". Pub. L. 100−203, Sec. 4303(d)(2)(A), redesignated subsec. (g) as (e) and struck out former subsec. (e) relating to administration of an award. Subsec. (f). Pub. L. 100−203, Sec. 4303(d)(2)(A), struck out subsec. (f) which related to revision of an award.

324

Subsec. (g). Pub. L. 100−203, Sec. 4303(d)(2)(A), redesignated subsec. (g) as (e). −CHANGE− CHANGE OF NAME "United States magistrate judges" substituted for "United States magistrates" in subsec. (c)(6)(C) pursuant to section 321 of Pub. L. 101−650, set out as a note under section 631 of Title 28, Judiciary and Judicial Procedure. −MISC2− EFFECTIVE DATE OF 1992 AMENDMENT Amendment by Pub. L. 102−572 effective Oct. 29, 1992, see section 911 of Pub. L. 102−572, set out as a note under section 171 of Title 28, Judiciary and Judicial Procedure. EFFECTIVE DATE OF 1991 AMENDMENT Amendment by section 201(d)(1) of Pub. L. 102−168 effective as if in effect on and after Oct. 1, 1988, see section 201(i)(2) of Pub. L. 102−168, set out as a note under section 300aa−11 of this title. EFFECTIVE DATE OF 1990 AMENDMENT Amendment by Pub. L. 101−502 effective Sept. 30, 1990, see section 5(h) of Pub. L. 101−502, set out as a note under section 300aa−11 of this title. EFFECTIVE DATE OF 1989 AMENDMENT For applicability of amendments by Pub. L. 101−239 to petitions filed after Dec. 19, 1989, petitions currently pending in which the evidentiary record is closed, and petitions currently pending in which the evidentiary record is not closed, with provision for an

325

immediate suspension for 30 days of all pending cases, except that such suspension be excluded in determining the 240−day period prescribed in subsec. (d) of this section, see section 6601(s)(1) of Pub. L. 101−239, set out as a note under section 300aa−10 of this title. EFFECTIVE DATE OF 1988 AMENDMENT Except as specifically provided in section 411 of Pub. L. 100−360, amendment by Pub. L. 100−360, as it relates to a provision in the Omnibus Budget Reconciliation Act of 1987, Pub. L. 100−203, effective as if included in the enactment of that provision in Pub. L. 100−203, see section 411(a) of Pub. L. 100−360, set out as a Reference to OBRA; Effective Date note under section 106 of Title 1, General Provisions. TERMINATION OF REPORTING REQUIREMENTS For termination, effective May 15, 2000, of provisions in subsec. (c)(6)(E) of this section relating to reporting annually to the Congress, see section 3003 of Pub. L. 104−66, as amended, set out as a note under section 1113 of Title 31, Money and Finance, and page 13 of House Document No. 103−7. REVIEW BY 3−JUDGE PANEL Section 322(c) of Pub. L. 99−660, as added by Pub. L. 101−502, Sec. 5(g)(2), Nov. 3, 1990, 104 Stat. 1288, and amended by Pub. L. 102−572, title IX, Sec. 902(b)(1), Oct. 29, 1992, 106 Stat. 4516, provided that: "If the review authorized by section 2112(f) [subsec. (f) of this section] is held invalid because the judgment of the United States Court of Federal Claims being reviewed did not

326

arise from a case or controversy under Article III of the Constitution, such judgment shall be reviewed by a 3−judge panel of the United States Court of Federal Claims. Such panel shall not include the judge who participated in such judgment." [Enactment of section 322(c) of Pub. L. 99−660 by section 5(g)(2) of Pub. L. 101−502, set out above, effective Nov. 14, 1986, see section 5(h) of Pub. L. 101−502, set out as an Effective Date of 1990 Amendment note under section 300aa−11 of this title.] −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in sections 300aa−11, 300aa−15, 300aa−21 of this title. −FOOTNOTE− (!1) So in original. Probably should be a reference to the United States Court of Federal Claims. (!2) So in original. Probably should be a reference to the United States Court of Federal Claims. −End− −CITE− 42 USC Sec. 300aa−13 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XIX − VACCINES Part 2 − National Vaccine Injury Compensation Program subpart a − program requirements

327

−HEAD− Sec. 300aa−13. Determination of eligibility and compensation −STATUTE− (a) General rule (1) Compensation shall be awarded under the Program to a petitioner if the special master or court finds on the record as a whole − (A) that the petitioner has demonstrated by a preponderance of the evidence the matters required in the petition by section 300aa−11(c)(1) of this title, and (B) that there is not a preponderance of the evidence that the illness, disability, injury, condition, or death described in the petition is due to factors unrelated to the administration of the vaccine described in the petition. The special master or court may not make such a finding based on the claims of a petitioner alone, unsubstantiated by medical records or by medical opinion. (2) For purposes of paragraph (1), the term "factors unrelated to the administration of the vaccine" − (A) does not include any idiopathic, unexplained, unknown, hypothetical, or undocumentable cause, factor, injury, illness, or condition, and (B) may, as documented by the petitioner's evidence or other material in the record, include infection, toxins, trauma (including birth trauma and related anoxia), or metabolic disturbances which have no known relation to the vaccine

328

involved, but which in the particular case are shown to have been the agent or agents principally responsible for causing the petitioner's illness, disability, injury, condition, or death. (b) Matters to be considered (1) In determining whether to award compensation to a petitioner under the Program, the special master or court shall consider, in addition to all other relevant medical and scientific evidence contained in the record − (A) any diagnosis, conclusion, medical judgment, or autopsy or coroner's report which is contained in the record regarding the nature, causation, and aggravation of the petitioner's illness, disability, injury, condition, or death, and (B) the results of any diagnostic or evaluative test which are contained in the record and the summaries and conclusions. Any such diagnosis, conclusion, judgment, test result, report, or summary shall not be binding on the special master or court. In evaluating the weight to be afforded to any such diagnosis, conclusion, judgment, test result, report, or summary, the special master or court shall consider the entire record and the course of the injury, disability, illness, or condition until the date of the judgment of the special master or court. (2) The special master or court may find the first symptom or manifestation of onset or significant aggravation of an injury, disability, illness, condition, or death described in a petition occurred within the time period described in the Vaccine Injury Table even though the occurrence of such symptom or manifestation

329

was not recorded or was incorrectly recorded as having occurred outside such period. Such a finding may be made only upon demonstration by a preponderance of the evidence that the onset or significant aggravation of the injury, disability, illness, condition, or death described in the petition did in fact occur within the time period described in the Vaccine Injury Table. (c) "Record" defined For purposes of this section, the term "record" means the record established by the special masters of the United States Court of Federal Claims in a proceeding on a petition filed under section 300aa−11 of this title. −SOURCE− (July 1, 1944, ch. 373, title XXI, Sec. 2113, as added Pub. L. 99−660, title III, Sec. 311(a), Nov. 14, 1986, 100 Stat. 3763; amended Pub. L. 100−203, title IV, Sec. 4307(4), Dec. 22, 1987, 101 Stat. 1330−224; Pub. L. 101−239, title VI, Sec. 6601(j), Dec. 19, 1989, 103 Stat. 2290; Pub. L. 101−502, Sec. 5(c), Nov. 3, 1990, 104 Stat. 1287; Pub. L. 102−572, title IX, Sec. 902(b)(1), Oct. 29, 1992, 106 Stat. 4516.) −MISC1− PRIOR PROVISIONS A prior section 300aa−13, act July 1, 1944, Sec. 2114, was successively renumbered by subsequent acts and transferred, see section 238k of this title. A prior section 2113 of act July 1, 1944, was successively renumbered by subsequent acts and transferred, see section 238j of

330

this title. AMENDMENTS 1992 − Subsec. (c). Pub. L. 102−572 substituted "United States Court of Federal Claims" for "United States Claims Court". 1990 − Subsec. (c). Pub. L. 101−502 inserted "the" after "special masters of". 1989 − Subsecs. (a)(1), (b). Pub. L. 101−239, Sec. 6601(j)(1), substituted "special master or court" for "court" wherever appearing. Subsec. (c). Pub. L. 101−239, Sec. 6601(j)(2), inserted "special masters of" after "established by the". 1987 − Subsec. (c). Pub. L. 100−203 substituted "the United States Claims Court" for "a district court of the United States". EFFECTIVE DATE OF 1992 AMENDMENT Amendment by Pub. L. 102−572 effective Oct. 29, 1992, see section 911 of Pub. L. 102−572, set out as a note under section 171 of Title 28, Judiciary and Judicial Procedure. EFFECTIVE DATE OF 1990 AMENDMENT Amendment by Pub. L. 101−502 effective Sept. 30, 1990, see section 5(h) of Pub. L. 101−502, set out as a note under section 300aa−11 of this title. EFFECTIVE DATE OF 1989 AMENDMENT For applicability of amendments by Pub. L. 101−239 to petitions filed after Dec. 19, 1989, petitions currently pending in which the evidentiary record is closed, and petitions currently pending in which the evidentiary record is not closed, with provision for an

331

immediate suspension for 30 days of all pending cases, see section 6601(s)(1) of Pub. L. 101−239, set out as a note under section 300aa−10 of this title. −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in section 300aa−12 of this title. −End− −CITE− 42 USC Sec. 300aa−14 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XIX − VACCINES Part 2 − National Vaccine Injury Compensation Program subpart a − program requirements −HEAD− Sec. 300aa−14. Vaccine Injury Table −STATUTE− (a) Initial table The following is a table of vaccines, the injuries, disabilities, illnesses, conditions, and deaths resulting from the administration of such vaccines, and the time period in which the first symptom or manifestation of onset or of the significant aggravation of such injuries, disabilities, illnesses, conditions, and deaths is to occur after vaccine administration for purposes of receiving compensation under the Program:

332

VACCINE INJURY TABLE −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− I. DTP; P; DTP/Polio Combination; or Any Other Vaccine Containing Whole Cell Pertussis Bacteria, Extracted or Partial Cell Bacteria, or Specific Pertussis Antigen(s). Illness, disability, Time period for first injury, or condition symptom or covered: manifestation of onset or of significant aggravation after vaccine administration: A. Anaphylaxis or 24 hours anaphylactic shock B. Encephalopathy (or 3 days encephalitis) C. Shock−collapse or 3 days hypotonic− hyporesponsive collapse D. Residual seizure 3 days disorder in accordance

333

with subsection (b)(2) E. Any acute Not applicable complication or sequela (including death) of an illness, disability, injury, or condition referred to above which illness, disability, injury, or condition arose within the time period prescribed II. Measles, mumps, rubella, or any vaccine containing any of the foregoing as a component; DT; Td; or Tetanus Toxoid. A. Anaphylaxis or 24 hours anaphylactic shock B. Encephalopathy (or 15 days (for mumps, encephalitis) rubella, measles, or any vaccine containing any of the foregoing as a component). 3 days (for DT, Td, or tetanus toxoid).

334

C. Residual seizure 15 days (for mumps, disorder in accordance rubella, measles, or with subsection (b)(2) any vaccine containing any of the foregoing as a component). 3 days (for DT, Td, or tetanus toxoid). D. Any acute Not applicable complication or sequela (including death) of an illness, disability, injury, or condition referred to above which illness, disability, injury, or condition arose within the time period prescribed III. Polio Vaccines (other than Inactivated Polio Vaccine). A. Paralytic polio − in a 30 days non−immunodeficient recipient − in an 6 months immunodeficient

335

recipient − in a Not applicable vaccine−associated community case B. Any acute Not applicable complication or sequela (including death) of an illness, disability, injury, or condition referred to above which illness, disability, injury, or condition arose within the time period prescribed IV. Inactivated Polio Vaccine. A. Anaphylaxis or 24 hours anaphylactic shock B. Any acute Not applicable complication or sequela (including death) of an illness, disability, injury, or condition referred to above which illness, disability, injury, or condition

336

arose within the time period prescribed −−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−−− (b) Qualifications and aids to interpretation The following qualifications and aids to interpretation shall apply to the Vaccine Injury Table in subsection (a) of this section: (1) A shock−collapse or a hypotonic−hyporesponsive collapse may be evidenced by indicia or symptoms such as decrease or loss of muscle tone, paralysis (partial or complete), hemiplegia or hemiparesis, loss of color or turning pale white or blue, unresponsiveness to environmental stimuli, depression of consciousness, loss of consciousness, prolonged sleeping with difficulty arousing, or cardiovascular or respiratory arrest. (2) A petitioner may be considered to have suffered a residual seizure disorder if the petitioner did not suffer a seizure or convulsion unaccompanied by fever or accompanied by a fever of less than 102 degrees Fahrenheit before the first seizure or convulsion after the administration of the vaccine involved and if − (A) in the case of a measles, mumps, or rubella vaccine or any combination of such vaccines, the first seizure or convulsion occurred within 15 days after administration of the vaccine and 2 or more seizures or convulsions occurred within 1 year after the administration of the vaccine which were unaccompanied by fever or accompanied by a fever of less than

337

102 degrees Fahrenheit, and (B) in the case of any other vaccine, the first seizure or convulsion occurred within 3 days after administration of the vaccine and 2 or more seizures or convulsions occurred within 1 year after the administration of the vaccine which were unaccompanied by fever or accompanied by a fever of less than 102 degrees Fahrenheit. (3)(A) The term "encephalopathy" means any significant acquired abnormality of, or injury to, or impairment of function of the brain. Among the frequent manifestations of encephalopathy are focal and diffuse neurologic signs, increased intracranial pressure, or changes lasting at least 6 hours in level of consciousness, with or without convulsions. The neurological signs and symptoms of encephalopathy may be temporary with complete recovery, or may result in various degrees of permanent impairment. Signs and symptoms such as high pitched and unusual screaming, persistent unconsolable crying, and bulging fontanel are compatible with an encephalopathy, but in and of themselves are not conclusive evidence of encephalopathy. Encephalopathy usually can be documented by slow wave activity on an electroencephalogram. (B) If in a proceeding on a petition it is shown by a preponderance of the evidence that an encephalopathy was caused by infection, toxins, trauma, or metabolic disturbances the encephalopathy shall not be considered to be a condition set forth in the table. If at the time a judgment is entered on a

338

petition filed under section 300aa−11 of this title for a vaccine−related injury or death it is not possible to determine the cause, by a preponderance of the evidence, of an encephalopathy, the encephalopathy shall be considered to be a condition set forth in the table. In determining whether or not an encephalopathy is a condition set forth in the table, the court shall consider the entire medical record. (4) For purposes of paragraphs (2) and (3), the terms "seizure" and "convulsion" include grand mal, petit mal, absence, myoclonic, tonic−clonic, and focal motor seizures and signs. If a provision of the table to which paragraph (1), (2), (3), or (4) applies is revised under subsection (c) or (d) of this section, such paragraph shall not apply to such provision after the effective date of the revision unless the revision specifies that such paragraph is to continue to apply. (c) Administrative revision of table (1) The Secretary may promulgate regulations to modify in accordance with paragraph (3) the Vaccine Injury Table. In promulgating such regulations, the Secretary shall provide for notice and opportunity for a public hearing and at least 180 days of public comment. (2) Any person (including the Advisory Commission on Childhood Vaccines) may petition the Secretary to propose regulations to amend the Vaccine Injury Table. Unless clearly frivolous, or initiated by the Commission, any such petition shall be referred to the Commission for its recommendations. Following −

339

(A) receipt of any recommendation of the Commission, or (B) 180 days after the date of the referral to the Commission, whichever occurs first, the Secretary shall conduct a rulemaking proceeding on the matters proposed in the petition or publish in the Federal Register a statement of reasons for not conducting such proceeding. (3) A modification of the Vaccine Injury Table under paragraph (1) may add to, or delete from, the list of injuries, disabilities, illnesses, conditions, and deaths for which compensation may be provided or may change the time periods for the first symptom or manifestation of the onset or the significant aggravation of any such injury, disability, illness, condition, or death. (4) Any modification under paragraph (1) of the Vaccine Injury Table shall apply only with respect to petitions for compensation under the Program which are filed after the effective date of such regulation. (d) Role of Commission Except with respect to a regulation recommended by the Advisory Commission on Childhood Vaccines, the Secretary may not propose a regulation under subsection (c) of this section or any revision thereof, unless the Secretary has first provided to the Commission a copy of the proposed regulation or revision, requested recommendations and comments by the Commission, and afforded the Commission at least 90 days to make such recommendations. (e) Additional vaccines (1) Vaccines recommended before August 1, 1993

340

By August 1, 1995, the Secretary shall revise the Vaccine Injury Table included in subsection (a) of this section to include − (A) vaccines which are recommended to the Secretary by the Centers for Disease Control and Prevention before August 1, 1993, for routine administration to children, (B) the injuries, disabilities, illnesses, conditions, and deaths associated with such vaccines, and (C) the time period in which the first symptoms or manifestations of onset or other significant aggravation of such injuries, disabilities, illnesses, conditions, and deaths associated with such vaccines may occur. (2) Vaccines recommended after August 1, 1993 When after August 1, 1993, the Centers for Disease Control and Prevention recommends a vaccine to the Secretary for routine administration to children, the Secretary shall, within 2 years of such recommendation, amend the Vaccine Injury Table included in subsection (a) of this section to include − (A) vaccines which were recommended for routine administration to children, (B) the injuries, disabilities, illnesses, conditions, and deaths associated with such vaccines, and (C) the time period in which the first symptoms or manifestations of onset or other significant aggravation of such injuries, disabilities, illnesses, conditions, and deaths associated with such vaccines may occur.

341

−SOURCE− (July 1, 1944, ch. 373, title XXI, Sec. 2114, as added Pub. L. 99−660, title III, Sec. 311(a), Nov. 14, 1986, 100 Stat. 3764; amended Pub. L. 101−239, title VI, Sec. 6601(k), Dec. 19, 1989, 103 Stat. 2290; Pub. L. 103−66, title XIII, Sec. 13632(a)(2), Aug. 10, 1993, 107 Stat. 645.) −MISC1− PRIOR PROVISIONS A prior section 300aa−14, act July 1, 1944, Sec. 2115, was successively renumbered by subsequent acts and transferred, see section 238l of this title. A prior section 2114 of act July 1, 1944, was successively renumbered by subsequent acts and transferred, see section 238k of this title. AMENDMENTS 1993 − Subsec. (e). Pub. L. 103−66 amended heading and text of subsec. (e) generally. Prior to amendment, text read as follows: "The Secretary may recommend to Congress revisions of the table to change the vaccines covered by the table." 1989 − Subsec. (a). Pub. L. 101−239, Sec. 6601(k)(1), substituted "(b)(2)" for "(c)(2)" in items I.D. and II.C. in table. Subsec. (b)(3)(B). Pub. L. 101−239, Sec. 6601(k)(2), substituted "300aa−11 of this title" for "300aa−11(b) of this title". EFFECTIVE DATE OF 1989 AMENDMENT For applicability of amendments by Pub. L. 101−239 to petitions filed after Dec. 19, 1989, petitions currently pending in which the

342

evidentiary record is closed, and petitions currently pending in which the evidentiary record is not closed, with provision for an immediate suspension for 30 days of all pending cases, see section 6601(s)(1) of Pub. L. 101−239, set out as a note under section 300aa−10 of this title. REVISIONS OF VACCINE INJURY TABLE The Vaccine Injury Table as modified by regulations promulgated by the Secretary of Health and Human Services is set out at 42 CFR 100.3. Section 13632(a)(3) of Pub. L. 103−66 provided that: "A revision by the Secretary under section 2114(e) of the Public Health Service Act (42 U.S.C. 300aa−14(e)) (as amended by paragraph (2)) shall take effect upon the effective date of a tax enacted to provide funds for compensation paid with respect to the vaccine to be added to the vaccine injury table in section 2114(a) of the Public Health Service Act (42 U.S.C. 300aa−14(a))." −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in sections 300aa−25, 300aa−33 of this title. −End− −CITE− 42 USC Sec. 300aa−15 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE

343

SUBCHAPTER XIX − VACCINES Part 2 − National Vaccine Injury Compensation Program subpart a − program requirements −HEAD− Sec. 300aa−15. Compensation −STATUTE− (a) General rule Compensation awarded under the Program to a petitioner under section 300aa−11 of this title for a vaccine−related injury or death associated with the administration of a vaccine after October 1, 1988, shall include the following: (1)(A) Actual unreimbursable expenses incurred from the date of the judgment awarding such expenses and reasonable projected unreimbursable expenses which − (i) result from the vaccine−related injury for which the petitioner seeks compensation, (ii) have been or will be incurred by or on behalf of the person who suffered such injury, and (iii)(I) have been or will be for diagnosis and medical or other remedial care determined to be reasonably necessary, or (II) have been or will be for rehabilitation, developmental evaluation, special education, vocational training and placement, case management services, counseling, emotional or behavioral therapy, residential and custodial care and service expenses, special equipment, related travel expenses, and facilities determined to be reasonably necessary.

344

(B) Subject to section 300aa−16(a)(2) of this title, actual unreimbursable expenses incurred before the date of the judgment awarding such expenses which − (i) resulted from the vaccine−related injury for which the petitioner seeks compensation, (ii) were incurred by or on behalf of the person who suffered such injury, and (iii) were for diagnosis, medical or other remedial care, rehabilitation, developmental evaluation, special education, vocational training and placement, case management services, counseling, emotional or behavioral therapy, residential and custodial care and service expenses, special equipment, related travel expenses, and facilities determined to be reasonably necessary. (2) In the event of a vaccine−related death, an award of $250,000 for the estate of the deceased. (3)(A) In the case of any person who has sustained a vaccine−related injury after attaining the age of 18 and whose earning capacity is or has been impaired by reason of such person's vaccine−related injury for which compensation is to be awarded, compensation for actual and anticipated loss of earnings determined in accordance with generally recognized actuarial principles and projections. (B) In the case of any person who has sustained a vaccine−related injury before attaining the age of 18 and whose earning capacity is or has been impaired by reason of such

345

person's vaccine−related injury for which compensation is to be awarded and whose vaccine−related injury is of sufficient severity to permit reasonable anticipation that such person is likely to suffer impaired earning capacity at age 18 and beyond, compensation after attaining the age of 18 for loss of earnings determined on the basis of the average gross weekly earnings of workers in the private, non−farm sector, less appropriate taxes and the average cost of a health insurance policy, as determined by the Secretary. (4) For actual and projected pain and suffering and emotional distress from the vaccine−related injury, an award not to exceed $250,000. (b) Vaccines administered before effective date Compensation awarded under the Program to a petitioner under section 300aa−11 of this title for a vaccine−related injury or death associated with the administration of a vaccine before October 1, 1988, may include the compensation described in paragraphs (1)(A) and (2) of subsection (a) of this section and may also include an amount, not to exceed a combined total of $30,000, for − (1) lost earnings (as provided in paragraph (3) of subsection (a) of this section), (2) pain and suffering (as provided in paragraph (4) of subsection (a) of this section), and (3) reasonable attorneys' fees and costs (as provided in subsection (e) of this section.(!1)

346

(c) Residential and custodial care and service The amount of any compensation for residential and custodial care and service expenses under subsection (a)(1) of this section shall be sufficient to enable the compensated person to remain living at home. (d) Types of compensation prohibited Compensation awarded under the Program may not include the following: (1) Punitive or exemplary damages. (2) Except with respect to compensation payments under paragraphs (2) and (3) of subsection (a) of this section, compensation for other than the health, education, or welfare of the person who suffered the vaccine−related injury with respect to which the compensation is paid. (e) Attorneys' fees (1) In awarding compensation on a petition filed under section 300aa−11 of this title the special master or court shall also award as part of such compensation an amount to cover − (A) reasonable attorneys' fees, and (B) other costs, incurred in any proceeding on such petition. If the judgment of the United States Court of Federal Claims on such a petition does not award compensation, the special master or court may award an amount of compensation to cover petitioner's reasonable attorneys' fees and other costs incurred in any proceeding on such petition if the special master or court determines that the petition was brought in

347

good faith and there was a reasonable basis for the claim for which the petition was brought. (2) If the petitioner, before October 1, 1988, filed a civil action for damages for any vaccine−related injury or death for which compensation may be awarded under the Program, and petitioned under section 300aa−11(a)(5) of this title to have such action dismissed and to file a petition for compensation under the Program, in awarding compensation on such petition the special master or court may include an amount of compensation limited to the costs and expenses incurred by the petitioner and the attorney of the petitioner before October 1, 1988, in preparing, filing, and prosecuting such civil action (including the reasonable value of the attorney's time if the civil action was filed under contingent fee arrangements). (3) No attorney may charge any fee for services in connection with a petition filed under section 300aa−11 of this title which is in addition to any amount awarded as compensation by the special master or court under paragraph (1). (f) Payment of compensation (1) Except as provided in paragraph (2), no compensation may be paid until an election has been made, or has been deemed to have been made, under section 300aa−21(a) of this title to receive compensation. (2) Compensation described in subsection (a)(1)(A)(iii) of this section shall be paid from the date of the judgment of the United States Court of Federal Claims under section 300aa−12 of this title

348

awarding the compensation. Such compensation may not be paid after an election under section 300aa−21(a) of this title to file a civil action for damages for the vaccine−related injury or death for which such compensation was awarded. (3) Payments of compensation under the Program and the costs of carrying out the Program shall be exempt from reduction under any order issued under part C of the Balanced Budget and Emergency Deficit Control Act of 1985 [2 U.S.C. 900 et seq.]. (4)(A) Except as provided in subparagraph (B), payment of compensation under the Program shall be determined on the basis of the net present value of the elements of the compensation and shall be paid from the Vaccine Injury Compensation Trust Fund established under section 9510 of title 26 in a lump sum of which all or a portion may be used as ordered by the special master to purchase an annuity or otherwise be used, with the consent of the petitioner, in a manner determined by the special master to be in the best interests of the petitioner. (B) In the case of a payment of compensation under the Program to a petitioner for a vaccine−related injury or death associated with the administration of a vaccine before October 1, 1988, the compensation shall be determined on the basis of the net present value of the elements of compensation and shall be paid from appropriations made available under subsection (j) of this section in a lump sum of which all or a portion may be used as ordered by the special master to purchase an annuity or otherwise be used, with the consent of the petitioner, in a manner determined by the

349

special master to be in the best interests of the petitioner. Any reasonable attorneys' fees and costs shall be paid in a lump sum. If the appropriations under subsection (j) of this section are insufficient to make a payment of an annual installment, the limitation on civil actions prescribed by section 300aa−21(a) of this title shall not apply to a civil action for damages brought by the petitioner entitled to the payment. (C) In purchasing an annuity under subparagraph (A) or (B), the Secretary may purchase a guarantee for the annuity, may enter into agreements regarding the purchase price for and rate of return of the annuity, and may take such other actions as may be necessary to safeguard the financial interests of the United States regarding the annuity. Any payment received by the Secretary pursuant to the preceding sentence shall be paid to the Vaccine Injury Compensation Trust Fund established under section 9510 of title 26, or to the appropriations account from which the funds were derived to purchase the annuity, whichever is appropriate. (g) Program not primarily liable Payment of compensation under the Program shall not be made for any item or service to the extent that payment has been made, or can reasonably be expected to be made, with respect to such item or service (1) under any State compensation program, under an insurance policy, or under any Federal or State health benefits program (other than under title XIX of the Social Security Act [42 U.S.C. 1396 et seq.]), or (2) by an entity which provides health services on a prepaid basis.

350

(h) Liability of health insurance carriers, prepaid health plans, and benefit providers No policy of health insurance may make payment of benefits under the policy secondary to the payment of compensation under the Program and − (1) no State, and (2) no entity which provides health services on a prepaid basis or provides health benefits, may make the provision of health services or health benefits secondary to the payment of compensation under the Program, except that this subsection shall not apply to the provision of services or benefits under title XIX of the Social Security Act [42 U.S.C. 1396 et seq.]. (i) Source of compensation (1) Payment of compensation under the Program to a petitioner for a vaccine−related injury or death associated with the administration of a vaccine before October 1, 1988, shall be made by the Secretary from appropriations under subsection (j) of this section. (2) Payment of compensation under the Program to a petitioner for a vaccine−related injury or death associated with the administration of a vaccine on or after October 1, 1988, shall be made from the Vaccine Injury Compensation Trust Fund established under section 9510 of title 26. (j) Authorization For the payment of compensation under the Program to a petitioner

351

for a vaccine−related injury or death associated with the administration of a vaccine before October 1, 1988, there are authorized to be appropriated to the Department of Health and Human Services $80,000,000 for fiscal year 1989, $80,000,000 for fiscal year 1990, $80,000,000 for fiscal year 1991, $80,000,000 for fiscal year 1992, $110,000,000 for fiscal year 1993, and $110,000,000 for each succeeding fiscal year in which a payment of compensation is required under subsection (f)(4)(B) of this section. Amounts appropriated under this subsection shall remain available until expended. −SOURCE− (July 1, 1944, ch. 373, title XXI, Sec. 2115, as added Pub. L. 99−660, title III, Sec. 311(a), Nov. 14, 1986, 100 Stat. 3767; amended Pub. L. 100−203, title IV, Secs. 4302(b), 4303(a)−(d)(1), (e), (g), 4307(5), (6), Dec. 22, 1987, 101 Stat. 1330−221 to 1330−223, 1330−225; Pub. L. 100−360, title IV, Sec. 411(o)(1), July 1, 1988, 102 Stat. 808; Pub. L. 101−239, title VI, Sec. 6601(c)(8), (l), Dec. 19, 1989, 103 Stat. 2286, 2290; Pub. L. 101−502, Sec. 5(d), Nov. 3, 1990, 104 Stat. 1287; Pub. L. 102−168, title II, Sec. 201(e), (f), Nov. 26, 1991, 105 Stat. 1103; Pub. L. 102−531, title III, Sec. 314, Oct. 27, 1992, 106 Stat. 3508; Pub. L. 102−572, title IX, Sec. 902(b)(1), Oct. 29, 1992, 106 Stat. 4516; Pub. L. 103−66, title XIII, Sec. 13632(b), Aug. 10, 1993, 107 Stat. 646.) −REFTEXT− REFERENCES IN TEXT The Balanced Budget and Emergency Deficit Control Act of 1985,

352

referred to in subsec. (f)(3), is title II of Pub. L. 99−177, Dec. 12, 1985, 99 Stat. 1038. Part C of the Act is classified generally to subchapter I (Sec. 900 et seq.) of chapter 20 of Title 2, The Congress. For complete classification of this Act to the Code, see Short Title note set out under section 900 of Title 2 and Tables. The Social Security Act, referred to in subsecs. (g) and (h), is act Aug. 14, 1935, ch. 531, 49 Stat. 620, as amended. Title XIX of the Social Security Act is classified generally to subchapter XIX (Sec. 1396 et seq.) of chapter 7 of this title. For complete classification of this Act to the Code, see section 1305 of this title and Tables. −COD− CODIFICATION In subsecs. (a), (b), (e)(2), (f)(4)(B), (i), and (j), "October 1, 1988" substituted for "the effective date of this subpart" on authority of section 323 of Pub. L. 99−660, as amended, set out as an Effective Date note under section 300aa−1 of this title. −MISC1− PRIOR PROVISIONS A prior section 300aa−15, act July 1, 1944, Sec. 2116, was successively renumbered by subsequent acts and transferred, see section 238m of this title. A prior section 2115 of act July 1, 1944, was successively renumbered by subsequent acts and transferred, see section 238l of this title. AMENDMENTS

353

1993 − Subsec. (j). Pub. L. 103−66 substituted "$110,000,000 for each succeeding fiscal year" for "$80,000,000 for each succeeding fiscal year". 1992 − Subsecs. (e)(1), (f)(2). Pub. L. 102−572 substituted "United States Court of Federal Claims" for "United States Claims Court". Subsec. (j). Pub. L. 102−531 increased authorization for fiscal year 1993 from $80,000,000 to $110,000,000. 1991 − Subsec. (f)(4)(A). Pub. L. 102−168, Sec. 201(e)(1)(A), (2), struck out "of the proceeds" after "portion" and substituted "Vaccine Injury Compensation Trust Fund established under section 9510 of title 26" for "trust fund". Subsec. (f)(4)(B). Pub. L. 102−168, Sec. 201(e)(1)(B), which directed substitution of "shall be paid from appropriations made available under subsection (j) of this section in a lump sum of which all or a portion" for "paid in 4 equal installments of which all or portion of the proceeds" was executed by making the substitution for "paid in 4 equal annual installments of which all or a portion of the proceeds" to reflect the probable intent of Congress. Subsec. (f)(4)(C). Pub. L. 102−168, Sec. 201(f), added subpar. (C). 1990 − Subsec. (e)(2). Pub. L. 101−502, Sec. 5(d)(1), inserted "of compensation" before "limited to the costs". Subsec. (f)(2). Pub. L. 101−502, Sec. 5(d)(2)(A), substituted "section 300aa−21(a)" for "section 300aa−21(b)".

354

Subsec. (f)(4)(B). Pub. L. 101−502, Sec. 5(d)(2)(B), substituted "subsection (j)" for "subsection (i)" and "the limitation on civil actions prescribed by section 300aa−21(a) of this title" for "section 300aa−11(a) of this title". Subsec. (j). Pub. L. 101−502, Sec. 5(d)(3), inserted before period at end of first sentence ", and $80,000,000 for each succeeding fiscal year in which a payment of compensation is required under subsection (f)(4)(B) of this section". 1989 − Subsec. (b). Pub. L. 101−239, Sec. 6601(l)(1), substituted "may include the compensation described in paragraphs (1)(A) and (2) of subsection (a) of this section and may also include an amount, not to exceed a combined total of $30,000, for − " and cls. (1) to (3) for "may not include the compensation described in paragraph (1)(B) of subsection (a) of this section and may include attorneys' fees and other costs included in a judgment under subsection (e) of this section, except that the total amount that may be paid as compensation under paragraphs (3) and (4) of subsection (a) of this section and included as attorneys' fees and other costs under subsection (e) of this section may not exceed $30,000." Subsec. (e)(1). Pub. L. 101−239, Sec. 6601(l)(2)(A), substituted "In awarding compensation on a petition filed under section 300aa−11 of this title the special master or court shall also award as part of such compensation an amount to cover" for "The judgment of the United States Claims Court on a petition filed under section 300aa−11 of this title awarding compensation shall include an

355

amount to cover". Pub. L. 101−239, Sec. 6601(l)(2)(B), (C), substituted "the special master or court may award an amount of compensation to cover" for "the court may include in the judgment an amount to cover" and "the special master or court determines that the petition was brought in good faith and there was a reasonable basis for the claim for which the petition" for "the court determines that the civil action was brought in good faith and there was a reasonable basis for the claim for which the civil action". Subsec. (e)(2). Pub. L. 101−239, Sec. 6601(l)(2)(D), which directed amendment of par. (2) by substituting "the special master or court may also award an amount of compensation" for "the judgment of the court on such petition may include an amount", could not be executed because of the prior amendment by Pub. L. 101−239, Sec. 6601(c)(8)(B), see Amendment note below. Pub. L. 101−239, Sec. 6601(c)(8), substituted "and petitioned under section 300aa−11(a)(5) of this title to have such action dismissed" for "and elected under section 300aa−11(a)(4) of this title to withdraw such action" and "in awarding compensation on such petition the special master or court may include" for "the judgment of the court on such petition may include". Subsec. (e)(3). Pub. L. 101−239, Sec. 6601(l)(2)(E), substituted "awarded as compensation by the special master or court under paragraph (1)" for "included under paragraph (1) in a judgment on such petition". Subsec. (f)(3). Pub. L. 101−239, Sec. 6601(l)(3)(A), inserted

356

"under the Program and the costs of carrying out the Program" after "Payments of compensation". Subsec. (f)(4)(A). Pub. L. 101−239, Sec. 6601(l)(3)(B), struck out "made in a lump sum" after "the Program shall be" and inserted "and shall be paid from the trust fund in a lump sum of which all or a portion of the proceeds may be used as ordered by the special master to purchase an annuity or otherwise be used, with the consent of the petitioner, in a manner determined by the special master to be in the best interests of the petitioner" after "elements of the compensation". Subsec. (f)(4)(B). Pub. L. 101−239, Sec. 6601(l)(3)(C), substituted "determined on the basis of the net present value of the elements of compensation and paid in 4 equal annual installments of which all or a portion of the proceeds may be used as ordered by the special master to purchase an annuity or otherwise be used, with the consent of the petitioner, in a manner determined by the special master to be in the best interests of the petitioner. Any reasonable attorneys' fees and costs shall be paid in a lump sum" for "paid in 4 equal annual installments". Subsec. (g). Pub. L. 101−239, Sec. 6601(l)(4)(A), inserted "(other than under title XIX of the Social Security Act)" after "State health benefits program". Subsec. (h). Pub. L. 101−239, Sec. 6601(l)(4)(B), inserted before period at end ", except that this subsection shall not apply to the provision of services or benefits under title XIX of the Social Security Act".

357

Subsec. (i)(1). Pub. L. 101−239, Sec. 6601(l)(5), which directed amendment of par. (1) by substituting "(j)" for "(i)", could not be executed because "(i)" did not appear. Subsec. (j). Pub. L. 101−239, Sec. 6601(l)(6), struck out "and" after "fiscal year 1991," and inserted ", $80,000,000 for fiscal year 1993" after "fiscal year 1992". 1988 − Subsec. (i)(1). Pub. L. 100−360, Sec. 411(o)(1)(A), substituted "by the Secretary from appropriations under subsection (j)" for "from appropriations under subsection (i)". Subsec. (j). Pub. L. 100−360, Sec. 411(o)(1)(B), inserted "to the Department of Health and Human Services". 1987 − Subsec. (a). Pub. L. 100−203, Sec. 4302(b)(1), substituted "effective date of this subpart" for "effective date of this part". Pub. L. 100−203, Sec. 4303(d)(1)(A), struck out last two sentences which read as follows: "Payments for projected expenses shall be paid on a periodic basis (but no payment may be made for a period in excess of 1 year). Payments for pain and suffering and emotional distress and incurred expenses may be paid in a lump sum." Subsec. (a)(1). Pub. L. 100−203, Sec. 4303(c), struck out last sentence of subpars. (A) and (B) each of which read as follows: "The amount of unreimbursable expenses which may be recovered under this subparagraph shall be limited to the amount in excess of the amount set forth in section 300aa−11(c)(1)(D)(ii) of this title." Subsec. (b). Pub. L. 100−203, Sec. 4303(e), substituted "may not include the compensation described in paragraph (1)(B) of

358

subsection (a) of this section and may include attorneys' fees and other costs included in a judgment under subsection (e) of this section, except that the total amount that may be paid as compensation under paragraphs (3) and (4) of subsection (a) of this section and included as attorneys' fees and other costs under subsection (e) of this section may not exceed $30,000" for "shall only include the compensation described in paragraphs (1)(A) and (2) of subsection (a) of this section". Pub. L. 100−203, Sec. 4302(b)(1), substituted "effective date of this subpart" for "effective date of this part". Subsec. (e)(1). Pub. L. 100−203, Sec. 4307(5), substituted "of the United States Claims Court" for "of a court" in two places. Subsec. (e)(2). Pub. L. 100−203, Sec. 4302(b), substituted "effective date of this subpart, filed a" for "effective date of this subchapter, filed a" and "effective date of this subpart in preparing" for "effective date of this part in preparing". Subsec. (f). Pub. L. 100−203, Sec. 4303(d)(1)(B), (g), added par. (4) and redesignated a second subsec. (f), relating to the Program not being primarily liable, as subsec. (g). Subsec. (f)(2). Pub. L. 100−203, Sec. 4307(6), substituted "United States Claims Court" for "district court of the United States". Subsecs. (g), (h). Pub. L. 100−203, Sec. 4303(g), redesignated a second subsec. (f), relating to the Program not being liable, as (g) and redesignated former subsec. (g) as (h). Subsecs. (i), (j). Pub. L. 100−203, Sec. 4303(a), (b), added

359

subsecs. (i) and (j). EFFECTIVE DATE OF 1992 AMENDMENT Amendment by Pub. L. 102−572 effective Oct. 29, 1992, see section 911 of Pub. L. 102−572, set out as a note under section 171 of Title 28, Judiciary and Judicial Procedure. EFFECTIVE DATE OF 1991 AMENDMENT Amendment by section 201(f) of Pub. L. 102−168 effective as if in effect on and after Oct. 1, 1988, see section 201(i)(2) of Pub. L. 102−168, set out as a note under section 300aa−11 of this title. EFFECTIVE DATE OF 1990 AMENDMENT Amendment by Pub. L. 101−502 effective Sept. 30, 1990, see section 5(h) of Pub. L. 101−502, set out as a note under section 300aa−11 of this title. EFFECTIVE DATE OF 1989 AMENDMENT Amendment by Pub. L. 101−239 applicable to all pending and subsequently filed petitions, see section 6601(s)(2) of Pub. L. 101−239, set out as a note under section 300aa−10 of this title. EFFECTIVE DATE OF 1988 AMENDMENT Except as specifically provided in section 411 of Pub. L. 100−360, amendment by Pub. L. 100−360, as it relates to a provision in the Omnibus Budget Reconciliation Act of 1987, Pub. L. 100−203, effective as if included in the enactment of that provision in Pub. L. 100−203, see section 411(a) of Pub. L. 100−360, set out as a Reference to OBRA; Effective Date note under section 106 of Title 1, General Provisions. −FOOTNOTE−

360

(!1) So in original. Probably should be preceded by a closing parenthesis. −End− −CITE− 42 USC Sec. 300aa−16 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XIX − VACCINES Part 2 − National Vaccine Injury Compensation Program subpart a − program requirements −HEAD− Sec. 300aa−16. Limitations of actions −STATUTE− (a) General rule In the case of − (1) a vaccine set forth in the Vaccine Injury Table which is administered before October 1, 1988, if a vaccine−related injury or death occurred as a result of the administration of such vaccine, no petition may be filed for compensation under the Program for such injury or death after the expiration of 28 months after October 1, 1988, and no such petition may be filed if the first symptom or manifestation of onset or of the significant aggravation of such injury occurred more than 36 months after the date of administration of the vaccine, (2) a vaccine set forth in the Vaccine Injury Table which is

361

administered after October 1, 1988, if a vaccine−related injury occurred as a result of the administration of such vaccine, no petition may be filed for compensation under the Program for such injury after the expiration of 36 months after the date of the occurrence of the first symptom or manifestation of onset or of the significant aggravation of such injury, and (3) a vaccine set forth in the Vaccine Injury Table which is administered after October 1, 1988, if a death occurred as a result of the administration of such vaccine, no petition may be filed for compensation under the Program for such death after the expiration of 24 months from the date of the death and no such petition may be filed more than 48 months after the date of the occurrence of the first symptom or manifestation of onset or of the significant aggravation of the injury from which the death resulted. (b) Effect of revised table If at any time the Vaccine Injury Table is revised and the effect of such revision is to permit an individual who was not, before such revision, eligible to seek compensation under the Program, or to significantly increase the likelihood of obtaining compensation, such person may, notwithstanding section 300aa−11(b)(2) of this title, file a petition for such compensation not later than 2 years after the effective date of the revision, except that no compensation may be provided under the Program with respect to a vaccine−related injury or death covered under the revision of the table if −

362

(1) the vaccine−related death occurred more than 8 years before the date of the revision of the table, or (2) the vaccine−related injury occurred more than 8 years before the date of the revision of the table. (c) State limitations of actions If a petition is filed under section 300aa−11 of this title for a vaccine−related injury or death, limitations of actions under State law shall be stayed with respect to a civil action brought for such injury or death for the period beginning on the date the petition is filed and ending on the date (1) an election is made under section 300aa−21(a) of this title to file the civil action or (2) an election is made under section 300aa−21(b) of this title to withdraw the petition. −SOURCE− (July 1, 1944, ch. 373, title XXI, Sec. 2116, as added Pub. L. 99−660, title III, Sec. 311(a), Nov. 14, 1986, 100 Stat. 3769; amended Pub. L. 100−203, title IV, Sec. 4302(b)(2), Dec. 22, 1987, 101 Stat. 1330−221; Pub. L. 101−239, title VI, Sec. 6601(m)(1), Dec. 19, 1989, 103 Stat. 2291; Pub. L. 101−502, Sec. 5(e), Nov. 3, 1990, 104 Stat. 1287; Pub. L. 102−168, title II, Sec. 201(d)(2), Nov. 26, 1991, 105 Stat. 1103; Pub. L. 103−66, title XIII, Sec. 13632(a)(1), Aug. 10, 1993, 107 Stat. 645.) −COD− CODIFICATION In subsec. (a)(1) to (3), "October 1, 1988" and "October 1, 1988," substituted for "the effective date of this subpart" on

363

authority of section 323 of Pub. L. 99−660, as amended, set out as an Effective Date note under section 300aa−1 of this title. −MISC1− PRIOR PROVISIONS A prior section 2116 of act July 1, 1944, was successively renumbered by subsequent acts and transferred, see section 238m of this title. AMENDMENTS 1993 − Subsec. (b). Pub. L. 103−66 substituted "or to significantly increase the likelihood of obtaining compensation, such person may, notwithstanding section 300aa−11(b)(2) of this title, file" for "such person may file". 1991 − Subsec. (c). Pub. L. 102−168 substituted "or (2)" for ", (2)" and struck out ", or (3) the petition is considered withdrawn under section 300aa−21(b) of this title." 1990 − Subsec. (a)(1). Pub. L. 101−502, Sec. 5(e)(1), substituted "28 months" for "24 months" and inserted before comma at end "and no such petition may be filed if the first symptom or manifestation of onset or of the significant aggravation of such injury occurred more than 36 months after the date of administration of the vaccine". Subsec. (c). Pub. L. 101−502, Sec. 5(e)(2), substituted "and ending on the date (1) an election is made under section 300aa−21(a) of this title to file the civil action, (2) an election is made under section 300aa−21(b) of this title to withdraw the petition, or (3) the petition is considered withdrawn under section

364

300aa−21(b) of this title" for "and ending on the date a final judgment is entered on the petition". 1989 − Subsec. (c). Pub. L. 101−239 substituted "300aa−11 of this title" for "300aa−11(b) of this title". 1987 − Subsec. (a). Pub. L. 100−203 substituted "effective date of this subpart" for "effective date of this subchapter" in pars. (1) to (3). EFFECTIVE DATE OF 1991 AMENDMENT Amendment by Pub. L. 102−168 effective as if in effect on and after Oct. 1, 1988, see section 201(i)(2) of Pub. L. 102−168, set out as a note under section 300aa−11 of this title. EFFECTIVE DATE OF 1990 AMENDMENT Amendment by Pub. L. 101−502 effective Sept. 30, 1990, see section 5(h) of Pub. L. 101−502, set out as a note under section 300aa−11 of this title. EFFECTIVE DATE OF 1989 AMENDMENT For applicability of amendments by Pub. L. 101−239 to petitions filed after Dec. 19, 1989, petitions currently pending in which the evidentiary record is closed, and petitions currently pending in which the evidentiary record is not closed, with provision for an immediate suspension for 30 days of all pending cases, see section 6601(s)(1) of Pub. L. 101−239, set out as a note under section 300aa−10 of this title. −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in sections 300aa−11, 300aa−15,

365

300aa−21 of this title. −End− −CITE− 42 USC Sec. 300aa−17 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XIX − VACCINES Part 2 − National Vaccine Injury Compensation Program subpart a − program requirements −HEAD− Sec. 300aa−17. Subrogation −STATUTE− (a) General rule Upon payment of compensation to any petitioner under the Program, the trust fund which has been established to provide such compensation shall be subrograted (!1) to all rights of the petitioner with respect to the vaccine−related injury or death for which compensation was paid, except that the trust fund may not recover under such rights an amount greater than the amount of compensation paid to the petitioner. (b) Disposition of amounts recovered Amounts recovered under subsection (a) of this section shall be collected on behalf of, and deposited in, the Vaccine Injury Compensation Trust Fund established under section 9510 of title 26. −SOURCE−

366

(July 1, 1944, ch. 373, title XXI, Sec. 2117, as added Pub. L. 99−660, title III, Sec. 311(a), Nov. 14, 1986, 100 Stat. 3770; amended Pub. L. 100−203, title IV, Sec. 4307(7), Dec. 22, 1987, 101 Stat. 1330−225; Pub. L. 101−239, title VI, Sec. 6601(m)(2), Dec. 19, 1989, 103 Stat. 2291.) −MISC1− AMENDMENTS 1989 − Subsec. (b). Pub. L. 101−239 substituted "the Vaccine Injury Compensation Trust Fund established under section 9510 of title 26" for "the trust fund which has been established to provide compensation under the Program". 1987 − Subsec. (a). Pub. L. 100−203 struck out par. (1) designation before "Upon" and struck out par. (2) which read as follows: "In any case in which it deems such action appropriate, a district court of the United States may, after entry of a final judgment providing for compensation to be paid under section 300aa−15 of this title for a vaccine−related injury or death, refer the record of such proceeding to the Secretary and the Attorney General with such recommendation as the court deems appropriate with respect to the investigation or commencement of a civil action by the Secretary under paragraph (1)." EFFECTIVE DATE OF 1989 AMENDMENT For applicability of amendments by Pub. L. 101−239 to petitions filed after Dec. 19, 1989, petitions currently pending in which the evidentiary record is closed, and petitions currently pending in which the evidentiary record is not closed, with provision for an

367

immediate suspension for 30 days of all pending cases, see section 6601(s)(1) of Pub. L. 101−239, set out as a note under section 300aa−10 of this title. −FOOTNOTE− (!1) So in original. Probably should be "subrogated". −End− −CITE− 42 USC Sec. 300aa−18 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XIX − VACCINES Part 2 − National Vaccine Injury Compensation Program subpart a − program requirements −HEAD− Sec. 300aa−18. Repealed. Pub. L. 100−203, title IV, Sec. 4303(d)(2)(B), Dec. 22, 1987, 101 Stat. 1330−222 −MISC1− Section, act July 1, 1944, ch. 373, title XXI, Sec. 2118, as added Nov. 14, 1986, Pub. L. 99−660, title III, Sec. 311(a), 100 Stat. 3771, provided for annual increases for inflation of compensation under subsections (a)(2) and (a)(4) of section 300aa−15 of this title and civil penalty under section 300aa−27(b) of this title. −End− −CITE−

368

42 USC Sec. 300aa−19 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XIX − VACCINES Part 2 − National Vaccine Injury Compensation Program subpart a − program requirements −HEAD− Sec. 300aa−19. Advisory Commission on Childhood Vaccines −STATUTE− (a) Establishment There is established the Advisory Commission on Childhood Vaccines. The Commission shall be composed of: (1) Nine members appointed by the Secretary as follows: (A) Three members who are health professionals, who are not employees of the United States, and who have expertise in the health care of children, the epidemiology, etiology, and prevention of childhood diseases, and the adverse reactions associated with vaccines, of whom at least two shall be pediatricians. (B) Three members from the general public, of whom at least two shall be legal representatives of children who have suffered a vaccine−related injury or death. (C) Three members who are attorneys, of whom at least one shall be an attorney whose specialty includes representation of persons who have suffered a vaccine−related injury or death and

369

of whom one shall be an attorney whose specialty includes representation of vaccine manufacturers. (2) The Director of the National Institutes of Health, the Assistant Secretary for Health, the Director of the Centers for Disease Control and Prevention, and the Commissioner of Food and Drugs (or the designees of such officials), each of whom shall be a nonvoting ex officio member. The Secretary shall select members of the Commission within 90 days of October 1, 1988. The members of the Commission shall select a Chair from among the members. (b) Term of office Appointed members of the Commission shall be appointed for a term of office of 3 years, except that of the members first appointed, 3 shall be appointed for a term of 1 year, 3 shall be appointed for a term of 2 years, and 3 shall be appointed for a term of 3 years, as determined by the Secretary. (c) Meetings The Commission shall first meet within 60 days after all members of the Commission are appointed, and thereafter shall meet not less often than four times per year and at the call of the chair. A quorum for purposes of a meeting is 5. A decision at a meeting is to be made by a ballot of a majority of the voting members of the Commission present at the meeting. (d) Compensation Members of the Commission who are officers or employees of the Federal Government shall serve as members of the Commission without

370

compensation in addition to that received in their regular public employment. Members of the Commission who are not officers or employees of the Federal Government shall be compensated at a rate not to exceed the daily equivalent of the rate in effect for grade GS−18 of the General Schedule for each day (including traveltime) they are engaged in the performance of their duties as members of the Commission. All members, while so serving away from their homes or regular places of business, may be allowed travel expenses, including per diem in lieu of subsistence, in the same manner as such expenses are authorized by section 5703 of title 5 for employees serving intermittently. (e) Staff The Secretary shall provide the Commission with such professional and clerical staff, such information, and the services of such consultants as may be necessary to assist the Commission in carrying out effectively its functions under this section. (f) Functions The Commission shall − (1) advise the Secretary on the implementation of the Program, (2) on its own initiative or as the result of the filing of a petition, recommend changes in the Vaccine Injury Table, (3) advise the Secretary in implementing the Secretary's responsibilities under section 300aa−27 of this title regarding the need for childhood vaccination products that result in fewer or no significant adverse reactions, (4) survey Federal, State, and local programs and activities

371

relating to the gathering of information on injuries associated with the administration of childhood vaccines, including the adverse reaction reporting requirements of section 300aa−25(b) of this title, and advise the Secretary on means to obtain, compile, publish, and use credible data related to the frequency and severity of adverse reactions associated with childhood vaccines, and (5) recommend to the Director of the National Vaccine Program research related to vaccine injuries which should be conducted to carry out this part. −SOURCE− (July 1, 1944, ch. 373, title XXI, Sec. 2119, as added Pub. L. 99−660, title III, Sec. 311(a), Nov. 14, 1986, 100 Stat. 3771; amended Pub. L. 100−203, title IV, Sec. 4302(b)(1), Dec. 22, 1987, 101 Stat. 1330−221; Pub. L. 102−168, title II, Sec. 201(g), Nov. 26, 1991, 105 Stat. 1104; Pub. L. 102−531, title III, Sec. 312(d)(14), Oct. 27, 1992, 106 Stat. 3505.) −COD− CODIFICATION In subsec. (a), "October 1, 1988" substituted for "the effective date of this subpart" on authority of section 323 of Pub. L. 99−660, as amended, set out as an Effective Date note under section 300aa−1 of this title. −MISC1− AMENDMENTS 1992 − Subsec. (a)(2). Pub. L. 102−531 substituted "Centers for

372

Disease Control and Prevention" for "Centers for Disease Control". 1991 − Subsec. (c). Pub. L. 102−168 inserted "present at the meeting" before period at end. 1987 − Subsec. (a). Pub. L. 100−203 substituted "effective date of this subpart" for "effective date of this part" in last sentence. TERMINATION OF ADVISORY COMMISSIONS Advisory commissions established after Jan. 5, 1973, to terminate not later than the expiration of the 2−year period beginning on the date of their establishment, unless, in the case of a commission established by the President or an officer of the Federal Government, such commission is renewed by appropriate action prior to the expiration of such 2−year period, or in the case of a commission established by the Congress, its duration is otherwise provided by law. See sections 3(2) and 14 of Pub. L. 92−463, Oct. 6, 1972, 86 Stat. 776, set out in the Appendix to Title 5, Government Organization and Employees. Pub. L. 93−641, Sec. 6, Jan. 4, 1975, 88 Stat. 2275, set out as a note under section 217a of this title, provided that an advisory committee established pursuant to the Public Health Service Act shall terminate at such time as may be specifically prescribed by an Act of Congress enacted after Jan. 4, 1975. REFERENCES IN OTHER LAWS TO GS−16, 17, OR 18 PAY RATES References in laws to the rates of pay for GS−16, 17, or 18, or to maximum rates of pay under the General Schedule, to be considered references to rates payable under specified sections of

373

Title 5, Government Organization and Employees, see section 529 [title I, Sec. 101(c)(1)] of Pub. L. 101−509, set out in a note under section 5376 of Title 5. −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in section 300aa−33 of this title. −End− −CITE− 42 USC subpart b − additional remedies 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XIX − VACCINES Part 2 − National Vaccine Injury Compensation Program subpart b − additional remedies −HEAD− SUBPART B − ADDITIONAL REMEDIES −SECREF− SUBPART REFERRED TO IN OTHER SECTIONS This subpart is referred to in section 300aa−34 of this title. −End− −CITE− 42 USC Sec. 300aa−21 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE

374

SUBCHAPTER XIX − VACCINES Part 2 − National Vaccine Injury Compensation Program subpart b − additional remedies −HEAD− Sec. 300aa−21. Authority to bring actions −STATUTE− (a) Election After judgment has been entered by the United States Court of Federal Claims or, if an appeal is taken under section 300aa−12(f) of this title, after the appellate court's mandate is issued, the petitioner who filed the petition under section 300aa−11 of this title shall file with the clerk of the United States Court of Federal Claims − (1) if the judgment awarded compensation, an election in writing to receive the compensation or to file a civil action for damages for such injury or death, or (2) if the judgment did not award compensation, an election in writing to accept the judgment or to file a civil action for damages for such injury or death. An election shall be filed under this subsection not later than 90 days after the date of the court's final judgment with respect to which the election is to be made. If a person required to file an election with the court under this subsection does not file the election within the time prescribed for filing the election, such person shall be deemed to have filed an election to accept the judgment of the court. If a person elects to receive compensation

375

under a judgment of the court in an action for a vaccine−related injury or death associated with the administration of a vaccine before October 1, 1988, or is deemed to have accepted the judgment of the court in such an action, such person may not bring or maintain a civil action for damages against a vaccine administrator or manufacturer for the vaccine−related injury or death for which the judgment was entered. For limitations on the bringing of civil actions for vaccine−related injuries or deaths associated with the administration of a vaccine after October 1, 1988, see section 300aa−11(a)(2) of this title. (b) Continuance or withdrawal of petition A petitioner under a petition filed under section 300aa−11 of this title may submit to the United States Court of Federal Claims a notice in writing choosing to continue or to withdraw the petition if − (1) a special master fails to make a decision on such petition within the 240 days prescribed by section 300aa−12(d)(3)(A)(ii) of this title (excluding (i) any period of suspension under section 300aa−12(d)(3)(C) or 300aa−12(d)(3)(D) of this title, and (ii) any days the petition is before a special master as a result of a remand under section 300aa−12(e)(2)(C) of this title), or (2) the court fails to enter a judgment under section 300aa−12 of this title on the petition within 420 days (excluding (i) any period of suspension under section 300aa−12(d)(3)(C) or 300aa−12(d)(3)(D) of this title, and (ii) any days the petition is before a special master as a result of a remand under section

376

300aa−12(e)(2)(C) of this title) after the date on which the petition was filed. Such a notice shall be filed within 30 days of the provision of the notice required by section 300aa−12(g) of this title. (c) Limitations of actions A civil action for damages arising from a vaccine−related injury or death for which a petition was filed under section 300aa−11 of this title shall, except as provided in section 300aa−16(c) of this title, be brought within the period prescribed by limitations of actions under State law applicable to such civil action. −SOURCE− (July 1, 1944, ch. 373, title XXI, Sec. 2121, as added Pub. L. 99−660, title III, Sec. 311(a), Nov. 14, 1986, 100 Stat. 3772; amended Pub. L. 100−203, title IV, Secs. 4304(c), 4307(8), 4308(c), Dec. 22, 1987, 101 Stat. 1330−224, 1330−225; Pub. L. 100−360, title IV, Sec. 411(o)(3)(A), July 1, 1988, 102 Stat. 808; Pub. L. 101−239, title VI, Sec. 6601(n), Dec. 19, 1989, 103 Stat. 2291; Pub. L. 101−502, Sec. 5(f), Nov. 3, 1990, 104 Stat. 1287; Pub. L. 102−168, title II, Sec. 201(d)(3), Nov. 26, 1991, 105 Stat. 1103; Pub. L. 102−572, title IX, Sec. 902(b)(1), Oct. 29, 1992, 106 Stat. 4516.) −COD− CODIFICATION In subsec. (a), "October 1, 1988," and "October 1, 1988" substituted for "the effective date of this part". −MISC1−

377

AMENDMENTS 1992 − Subsecs. (a), (b). Pub. L. 102−572 substituted "United States Court of Federal Claims" for "United States Claims Court" wherever appearing. 1991 − Subsec. (b). Pub. L. 102−168 substituted "Continuance or withdrawal of petition" for "Withdrawal of petition" in heading, redesignated introductory provisions of par. (1) as introductory provisions of subsec. (b) and substituted "a notice in writing choosing to continue or to withdraw the petition" for "a notice in writing withdrawing the petition", redesignated subpars. (A) and (B) of former par. (1) as pars. (1) and (2), respectively, and realigned margins, struck out at end of former par. (1) "If such a notice is not filed before the expiration of such 30 days, the petition with respect to which the notice was to be filed shall be considered withdrawn under this paragraph.", and struck out par. (2) which read as follows: "If a special master or the court does not enter a decision or make a judgment on a petition filed under section 300aa−11 of this title within 30 days of the provision of the notice in accordance with section 300aa−12(g) of this title, the special master or court shall no longer have jurisdiction over such petition and such petition shall be considered as withdrawn under paragraph (1)." 1990 − Subsec. (a). Pub. L. 101−502, Sec. 5(f)(1), in closing provisions, inserted after second sentence "If a person elects to receive compensation under a judgment of the court in an action for a vaccine−related injury or death associated with the

378

administration of a vaccine before October 1, 1988, or is deemed to have accepted the judgment of the court in such an action, such person may not bring or maintain a civil action for damages against a vaccine administrator or manufacturer for the vaccine−related injury or death for which the judgment was entered." and inserted "for vaccine−related injuries or deaths associated with the administration of a vaccine after October 1, 1988" after "actions" in last sentence. Subsec. (b). Pub. L. 101−502, Sec. 5(f)(2), amended subsec. (b) generally. Prior to amendment, subsec. (b) read as follows: "If the United States Claims Court fails to enter a judgment under section 300aa−12 of this title on a petition filed under section 300aa−11 of this title within 420 days (excluding any period of suspension under section 300aa−12(d) of this title and excluding any days the petition is before a special master as a result of a remand under section 300aa−12(e)(2)(C) of this title) after the date on which the petition was filed, the petitioner may submit to the court a notice in writing withdrawing the petition. An election shall be filed under this subsection not later than 90 days after the date of the entry of the Claims Court's judgment or the appellate court's mandate with respect to which the election is to be made. A person who has submitted a notice under this subsection may, notwithstanding section 300aa−11(a)(2) of this title, thereafter maintain a civil action for damages in a State or Federal court without regard to this subpart and consistent with otherwise applicable law."

379

1989 − Subsec. (a). Pub. L. 101−239, Sec. 6601(n)(1)(A), amended introductory provisions generally. Prior to amendment, introductory provisions read as follows: "After the judgment of the United States Claims Court under section 300aa−11 of this title on a petition filed for compensation under the Program for a vaccine−related injury or death has become final, the person who filed the petition shall file with the court − ". Pub. L. 101−239, Sec. 6601(n)(1)(B), amended last sentence generally. Prior to amendment, last sentence read as follows: "If a person elects to receive compensation under a judgment of the court or is deemed to have accepted the judgment of the court, such person may not bring or maintain a civil action for damages against a vaccine manufacturer for the vaccine−related injury or death for which the judgment was entered." Subsec. (b). Pub. L. 101−239, Sec. 6601(n)(2), substituted "within 420 days (excluding any period of suspension under section 300aa−12(d) of this title and excluding any days the petition is before a special master as a result of a remand under section 300aa−12(e)(2)(C) of this title)" for "within 365 days" in first sentence and amended second sentence generally. Prior to amendment, second sentence read as follows: "Such a notice shall be filed not later than 90 days after the expiration of such 365−day period." 1988 − Subsec. (a). Pub. L. 100−360 added Pub. L. 100−203, Sec. 4308(c), see 1987 Amendment note below. 1987 − Subsec. (a). Pub. L. 100−203, Sec. 4308(c), as added by Pub. L. 100−360, substituted "the court's final judgment" for "the

380

entry of the court's judgment" in concluding provisions. Pub. L. 100−203, Sec. 4307(8), substituted "the United States Claims Court" for "a district court of the United States" and "the court" for "a court" in three places. Subsecs. (b), (c). Pub. L. 100−203, Sec. 4304(c), added subsec. (b) and redesignated former subsec. (b) as (c). EFFECTIVE DATE OF 1992 AMENDMENT Amendment by Pub. L. 102−572 effective Oct. 29, 1992, see section 911 of Pub. L. 102−572, set out as a note under section 171 of Title 28, Judiciary and Judicial Procedure. EFFECTIVE DATE OF 1991 AMENDMENT Amendment by Pub. L. 102−168 effective as in effect on and after Oct. 1, 1988, see section 201(i)(2) of Pub. L. 102−168, set out as a note under section 300aa−11 of this title. EFFECTIVE DATE OF 1990 AMENDMENT Amendment by section 5(f)(1) of Pub. L. 101−502 effective Nov. 14, 1986, and amendment by section 5(f)(2) of Pub. L. 101−502 effective Sept. 30, 1990, see section 5(h) of Pub. L. 101−502, set out as a note under section 300aa−11 of this title. EFFECTIVE DATE OF 1989 AMENDMENT For applicability of amendments by Pub. L. 101−239 to petitions filed after Dec. 19, 1989, petitions currently pending in which the evidentiary record is closed, and petitions currently pending in which the evidentiary record is not closed, with provision for an immediate suspension for 30 days of all pending cases, except that such suspension be excluded in determining the 420−day period

381

prescribed in subsec. (b) of this section, see section 6601(s)(1) of Pub. L. 101−239, set out as a note under section 300aa−10 of this title. EFFECTIVE DATE OF 1988 AMENDMENT Except as specifically provided in section 411 of Pub. L. 100−360, amendment by Pub. L. 100−360, as it relates to a provision in the Omnibus Budget Reconciliation Act of 1987, Pub. L. 100−203, effective as if included in the enactment of that provision in Pub. L. 100−203, see section 411(a) of Pub. L. 100−360, set out as a Reference to OBRA; Effective Date note under section 106 of Title 1, General Provisions. EFFECTIVE DATE Subpart effective Oct. 1, 1988, see section 323 of Pub. L. 99−660, set out as a note under section 300aa−1 of this title. −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in sections 300aa−11, 300aa−12, 300aa−15, 300aa−16, 300aa−34 of this title. −End− −CITE− 42 USC Sec. 300aa−22 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XIX − VACCINES Part 2 − National Vaccine Injury Compensation Program

382

subpart b − additional remedies −HEAD− Sec. 300aa−22. Standards of responsibility −STATUTE− (a) General rule Except as provided in subsections (b), (c), and (e) of this section State law shall apply to a civil action brought for damages for a vaccine−related injury or death. (b) Unavoidable adverse side effects; warnings (1) No vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine−related injury or death associated with the administration of a vaccine after October 1, 1988, if the injury or death resulted from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings. (2) For purposes of paragraph (1), a vaccine shall be presumed to be accompanied by proper directions and warnings if the vaccine manufacturer shows that it complied in all material respects with all requirements under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] and section 262 of this title (including regulations issued under such provisions) applicable to the vaccine and related to vaccine−related injury or death for which the civil action was brought unless the plaintiff shows − (A) that the manufacturer engaged in the conduct set forth in subparagraph (A) or (B) of section 300aa−23(d)(2) of this title, or

383

(B) by clear and convincing evidence that the manufacturer failed to exercise due care notwithstanding its compliance with such Act and section (and regulations issued under such provisions). (c) Direct warnings No vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine−related injury or death associated with the administration of a vaccine after October 1, 1988, solely due to the manufacturer's failure to provide direct warnings to the injured party (or the injured party's legal representative) of the potential dangers resulting from the administration of the vaccine manufactured by the manufacturer. (d) Construction The standards of responsibility prescribed by this section are not to be construed as authorizing a person who brought a civil action for damages against a vaccine manufacturer for a vaccine−related injury or death in which damages were denied or which was dismissed with prejudice to bring a new civil action against such manufacturer for such injury or death. (e) Preemption No State may establish or enforce a law which prohibits an individual from bringing a civil action against a vaccine manufacturer for damages for a vaccine−related injury or death if such civil action is not barred by this part. −SOURCE− (July 1, 1944, ch. 373, title XXI, Sec. 2122, as added Pub. L.

384

99−660, title III, Sec. 311(a), Nov. 14, 1986, 100 Stat. 3773; amended Pub. L. 100−203, title IV, Sec. 4302(b)(1), Dec. 22, 1987, 101 Stat. 1330−221.) −REFTEXT− REFERENCES IN TEXT The Federal Food, Drug, and Cosmetic Act, referred to in subsec. (b)(2), is act June 25, 1938, ch. 675, 52 Stat. 1040, as amended, which is classified generally to chapter 9 (Sec. 301 et seq.) of Title 21, Food and Drugs. For complete classification of this Act to the Code, see Tables. −COD− CODIFICATION In subsecs. (b)(1), (c), "October 1, 1988" was substituted for "the effective date of this subpart" on authority of section 323 of Pub. L. 99−660, as amended, set out as an Effective Date note under section 300aa−1 of this title. −MISC1− AMENDMENTS 1987 − Subsecs. (b)(1), (c). Pub. L. 100−203 substituted "effective date of this subpart" for "effective date of this part". −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in section 300aa−23 of this title. −End− −CITE− 42 USC Sec. 300aa−23 01/06/03

385

−EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XIX − VACCINES Part 2 − National Vaccine Injury Compensation Program subpart b − additional remedies −HEAD− Sec. 300aa−23. Trial −STATUTE− (a) General rule A civil action against a vaccine manufacturer for damages for a vaccine−related injury or death associated with the administration of a vaccine after October 1, 1988, which is not barred by section 300aa−11(a)(2) of this title shall be tried in three stages. (b) Liability The first stage of such a civil action shall be held to determine if a vaccine manufacturer is liable under section 300aa−22 of this title. (c) General damages The second stage of such a civil action shall be held to determine the amount of damages (other than punitive damages) a vaccine manufacturer found to be liable under section 300aa−22 of this title shall be required to pay. (d) Punitive damages (1) If sought by the plaintiff, the third stage of such an action shall be held to determine the amount of punitive damages a vaccine

386

manufacturer found to be liable under section 300aa−22 of this title shall be required to pay. (2) If in such an action the manufacturer shows that it complied, in all material respects, with all requirements under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] and this chapter applicable to the vaccine and related to the vaccine injury or death with respect to which the action was brought, the manufacturer shall not be held liable for punitive damages unless the manufacturer engaged in − (A) fraud or intentional and wrongful withholding of information from the Secretary during any phase of a proceeding for approval of the vaccine under section 262 of this title, (B) intentional and wrongful withholding of information relating to the safety or efficacy of the vaccine after its approval, or (C) other criminal or illegal activity relating to the safety and effectiveness of vaccines, which activity related to the vaccine−related injury or death for which the civil action was brought. (e) Evidence In any stage of a civil action, the Vaccine Injury Table, any finding of fact or conclusion of law of the United States Court of Federal Claims or a special master in a proceeding on a petition filed under section 300aa−11 of this title and the final judgment of the United States Court of Federal Claims and subsequent appellate review on such a petition shall not be admissible.

387

−SOURCE− (July 1, 1944, ch. 373, title XXI, Sec. 2123, as added Pub. L. 99−660, title III, Sec. 311(a), Nov. 14, 1986, 100 Stat. 3774; amended Pub. L. 100−203, title IV, Secs. 4302(b)(1), 4307(9), Dec. 22, 1987, 101 Stat. 1330−221, 1330−225; Pub. L. 101−239, title VI, Sec. 6601(o), Dec. 19, 1989, 103 Stat. 2292; Pub. L. 102−572, title IX, Sec. 902(b)(1), Oct. 29, 1992, 106 Stat. 4516.) −REFTEXT− REFERENCES IN TEXT The Federal Food, Drug, and Cosmetic Act, referred to in subsec. (d)(2), is act June 25, 1938, ch. 675, 52 Stat. 1040, as amended, which is classified generally to chapter 9 (Sec. 301 et seq.) of Title 21, Food and Drugs. For complete classification of this Act to the Code, see Tables. −COD− CODIFICATION In subsec. (a), "October 1, 1988" substituted for "the effective date of this subpart" on authority of section 323 of Pub. L. 99−660, as amended, set out as an Effective Date note under section 300aa−1 of this title. −MISC1− AMENDMENTS 1992 − Subsec. (e). Pub. L. 102−572 substituted "United States Court of Federal Claims" for "United States Claims Court" in two places. 1989 − Subsec. (e). Pub. L. 101−239 substituted "finding of fact

388

or conclusion of law" for "finding", "special master" for "master appointed by such court", and directed substitution of "the United States Claims Court and subsequent appellate review" for "a district court of the United States" which was executed by inserting "and subsequent appellate review" after "the United States Claims Court" the second place it appeared to reflect the probable intent of Congress and the amendment by Pub. L. 100−203, Sec. 4307(a), see 1987 Amendment note below. 1987 − Subsec. (a). Pub. L. 100−203, Sec. 4302(b)(1), substituted "effective date of this subpart" for "effective date of this part". Subsec. (e). Pub. L. 100−203, Sec. 4307(9), substituted "the United States Claims Court" for "a district court of the United States" in two places. EFFECTIVE DATE OF 1992 AMENDMENT Amendment by Pub. L. 102−572 effective Oct. 29, 1992, see section 911 of Pub. L. 102−572, set out as a note under section 171 of Title 28, Judiciary and Judicial Procedure. EFFECTIVE DATE OF 1989 AMENDMENT For applicability of amendments by Pub. L. 101−239 to petitions filed after Dec. 19, 1989, petitions currently pending in which the evidentiary record is closed, and petitions currently pending in which the evidentiary record is not closed, with provision for an immediate suspension for 30 days of all pending cases, see section 6601(s)(1) of Pub. L. 101−239, set out as a note under section 300aa−10 of this title. −SECREF−

389

SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in section 300aa−22 of this title. −End− −CITE− 42 USC subpart c − assuring a safer childhood vaccination program in united states 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XIX − VACCINES Part 2 − National Vaccine Injury Compensation Program subpart c − assuring a safer childhood vaccination program in united states −HEAD− SUBPART C − ASSURING A SAFER CHILDHOOD VACCINATION PROGRAM IN UNITED STATES −End− −CITE− 42 USC Sec. 300aa−25 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XIX − VACCINES Part 2 − National Vaccine Injury Compensation Program subpart c − assuring a safer childhood vaccination program in united states

390

−HEAD− Sec. 300aa−25. Recording and reporting of information −STATUTE− (a) General rule Each health care provider who administers a vaccine set forth in the Vaccine Injury Table to any person shall record, or ensure that there is recorded, in such person's permanent medical record (or in a permanent office log or file to which a legal representative shall have access upon request) with respect to each such vaccine − (1) the date of administration of the vaccine, (2) the vaccine manufacturer and lot number of the vaccine, (3) the name and address and, if appropriate, the title of the health care provider administering the vaccine, and (4) any other identifying information on the vaccine required pursuant to regulations promulgated by the Secretary. (b) Reporting (1) Each health care provider and vaccine manufacturer shall report to the Secretary − (A) the occurrence of any event set forth in the Vaccine Injury Table, including the events set forth in section 300aa−14(b) of this title which occur within 7 days of the administration of any vaccine set forth in the Table or within such longer period as is specified in the Table or section, (B) the occurrence of any contraindicating reaction to a vaccine which is specified in the manufacturer's package insert, and

391

(C) such other matters as the Secretary may by regulation require. Reports of the matters referred to in subparagraphs (A) and (B) shall be made beginning 90 days after December 22, 1987. The Secretary shall publish in the Federal Register as soon as practicable after such date a notice of the reporting requirement. (2) A report under paragraph (1) respecting a vaccine shall include the time periods after the administration of such vaccine within which vaccine−related illnesses, disabilities, injuries, or conditions, the symptoms and manifestations of such illnesses, disabilities, injuries, or conditions, or deaths occur, and the manufacturer and lot number of the vaccine. (3) The Secretary shall issue the regulations referred to in paragraph (1)(C) within 180 days of December 22, 1987. (c) Release of information (1) Information which is in the possession of the Federal Government and State and local governments under this section and which may identify an individual shall not be made available under section 552 of title 5, or otherwise, to any person except − (A) the person who received the vaccine, or (B) the legal representative of such person. (2) For purposes of paragraph (1), the term "information which may identify an individual" shall be limited to the name, street address, and telephone number of the person who received the vaccine and of that person's legal representative and the medical records of such person relating to the administration of the

392

vaccine, and shall not include the locality and State of vaccine administration, the name of the health care provider who administered the vaccine, the date of the vaccination, or information concerning any reported illness, disability, injury, or condition resulting from the administration of the vaccine, any symptom or manifestation of such illness, disability, injury, or condition, or death resulting from the administration of the vaccine. (3) Except as provided in paragraph (1), all information reported under this section shall be available to the public. −SOURCE− (July 1, 1944, ch. 373, title XXI, Sec. 2125, as added Pub. L. 99−660, title III, Sec. 311(a), Nov. 14, 1986, 100 Stat. 3774; amended Pub. L. 100−203, title IV, Sec. 4302(b)(1), Dec. 22, 1987, 101 Stat. 1330−221.) −COD− CODIFICATION In subsec. (b)(1), (3), "December 22, 1987" was substituted for "the effective date of this subpart" on authority of section 323 of Pub. L. 99−660, as amended, set out as an Effective Date note under section 300aa−1 of this title. −MISC1− AMENDMENTS 1987 − Subsec. (b)(1), (3). Pub. L. 100−203 substituted "effective date of this subpart" for "effective date of this part". EFFECTIVE DATE

393

Subpart effective Dec. 22, 1987, see section 323 of Pub. L. 99−660, set out as a note under section 300aa−1 of this title. −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in section 300aa−19 of this title. −End− −CITE− 42 USC Sec. 300aa−26 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XIX − VACCINES Part 2 − National Vaccine Injury Compensation Program subpart c − assuring a safer childhood vaccination program in united states −HEAD− Sec. 300aa−26. Vaccine information −STATUTE− (a) General rule Not later than 1 year after December 22, 1987, the Secretary shall develop and disseminate vaccine information materials for distribution by health care providers to the legal representatives of any child or to any other individual receiving a vaccine set forth in the Vaccine Injury Table. Such materials shall be published in the Federal Register and may be revised. (b) Development and revision of materials

394

Such materials shall be developed or revised − (1) after notice to the public and 60 days of comment thereon, and (2) in consultation with the Advisory Commission on Childhood Vaccines, appropriate health care providers and parent organizations, the Centers for Disease Control and Prevention, and the Food and Drug Administration. (c) Information requirements The information in such materials shall be based on available data and information, shall be presented in understandable terms and shall include − (1) a concise description of the benefits of the vaccine, (2) a concise description of the risks associated with the vaccine, (3) a statement of the availability of the National Vaccine Injury Compensation Program, and (4) such other relevant information as may be determined by the Secretary. (d) Health care provider duties On and after a date determined by the Secretary which is − (1) after the Secretary develops the information materials required by subsection (a) of this section, and (2) not later than 6 months after the date such materials are published in the Federal Register, each health care provider who administers a vaccine set forth in the Vaccine Injury Table shall provide to the legal representatives

395

of any child or to any other individual to whom such provider intends to administer such vaccine a copy of the information materials developed pursuant to subsection (a) of this section, supplemented with visual presentations or oral explanations, in appropriate cases. Such materials shall be provided prior to the administration of such vaccine. −SOURCE− (July 1, 1944, ch. 373, title XXI, Sec. 2126, as added Pub. L. 99−660, title III, Sec. 311(a), Nov. 14, 1986, 100 Stat. 3775; amended Pub. L. 100−203, title IV, Sec. 4302(b)(1), Dec. 22, 1987, 101 Stat. 1330−221; Pub. L. 101−239, title VI, Sec. 6601(p), Dec. 19, 1989, 103 Stat. 2292; Pub. L. 102−531, title III, Sec. 312(d)(15), Oct. 27, 1992, 106 Stat. 3505; Pub. L. 103−183, title VII, Sec. 708, Dec. 14, 1993, 107 Stat. 2242.) −COD− CODIFICATION In subsec. (a), "December 22, 1987" substituted for "the effective date of this subpart" on authority of section 323 of Pub. L. 99−660, as amended, set out as an Effective Date note under section 300aa−1 of this title. −MISC1− AMENDMENTS 1993 − Subsec. (a). Pub. L. 103−183, Sec. 708(c), inserted "or to any other individual" after "to the legal representatives of any child". Subsec. (b). Pub. L. 103−183, Sec. 708(a), struck out "by rule"

396

after "revised" in introductory provisions and substituted "and 60" for ", opportunity for a public hearing, and 90" in par. (1). Subsec. (c). Pub. L. 103−183, Sec. 708(b), inserted in introductory provisions "shall be based on available data and information," after "such materials", added pars. (1) to (4), and struck out former pars. (1) to (10) which read as follows: "(1) the frequency, severity, and potential long−term effects of the disease to be prevented by the vaccine, "(2) the symptoms or reactions to the vaccine which, if they occur, should be brought to the immediate attention of the health care provider, "(3) precautionary measures legal representatives should take to reduce the risk of any major adverse reactions to the vaccine that may occur, "(4) early warning signs or symptoms to which legal representatives should be alert as possible precursors to such major adverse reactions, "(5) a description of the manner in which legal representatives should monitor such major adverse reactions, including a form on which reactions can be recorded to assist legal representatives in reporting information to appropriate authorities, "(6) a specification of when, how, and to whom legal representatives should report any major adverse reaction, "(7) the contraindications to (and bases for delay of) the administration of the vaccine, "(8) an identification of the groups, categories, or

397

characteristics of potential recipients of the vaccine who may be at significantly higher risk of major adverse reaction to the vaccine than the general population, "(9) a summary of − "(A) relevant Federal recommendations concerning a complete schedule of childhood immunizations, and "(B) the availability of the Program, and "(10) such other relevant information as may be determined by the Secretary." Subsec. (d). Pub. L. 103−183, Sec. 708(c), (d), in concluding provisions, inserted "or to any other individual" after "to the legal representatives of any child", substituted "supplemented with visual presentations or oral explanations, in appropriate cases" for "or other written information which meets the requirements of this section", and struck out "or other information" after "Such materials". 1992 − Subsec. (b)(2). Pub. L. 102−531 substituted "Centers for Disease Control and Prevention" for "Centers for Disease Control". 1989 − Subsec. (c)(9). Pub. L. 101−239 amended par. (9) generally. Prior to amendment, par. (9) read as follows: "a summary of relevant State and Federal laws concerning the vaccine, including information on − "(A) the number of vaccinations required for school attendance and the schedule recommended for such vaccinations, and "(B) the availability of the Program, and". 1987 − Subsec. (a). Pub. L. 100−203 substituted "effective date

398

of this subpart" for "effective date of this part". EFFECTIVE DATE OF 1989 AMENDMENT For applicability of amendments by Pub. L. 101−239 to petitions filed after Dec. 19, 1989, petitions currently pending in which the evidentiary record is closed, and petitions currently pending in which the evidentiary record is not closed, with provision for an immediate suspension for 30 days of all pending cases, see section 6601(s)(1) of Pub. L. 101−239, set out as a note under section 300aa−10 of this title. −End− −CITE− 42 USC Sec. 300aa−27 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XIX − VACCINES Part 2 − National Vaccine Injury Compensation Program subpart c − assuring a safer childhood vaccination program in united states −HEAD− Sec. 300aa−27. Mandate for safer childhood vaccines −STATUTE− (a) General rule In the administration of this part and other pertinent laws under the jurisdiction of the Secretary, the Secretary shall − (1) promote the development of childhood vaccines that result

399

in fewer and less serious adverse reactions than those vaccines on the market on December 22, 1987, and promote the refinement of such vaccines, and (2) make or assure improvements in, and otherwise use the authorities of the Secretary with respect to, the licensing, manufacturing, processing, testing, labeling, warning, use instructions, distribution, storage, administration, field surveillance, adverse reaction reporting, and recall of reactogenic lots or batches, of vaccines, and research on vaccines, in order to reduce the risks of adverse reactions to vaccines. (b) Task force (1) The Secretary shall establish a task force on safer childhood vaccines which shall consist of the Director of the National Institutes of Health, the Commissioner of the Food and Drug Administration, and the Director of the Centers for Disease Control. (2) The Director of the National Institutes of Health shall serve as chairman of the task force. (3) In consultation with the Advisory Commission on Childhood Vaccines, the task force shall prepare recommendations to the Secretary concerning implementation of the requirements of subsection (a) of this section. (c) Report Within 2 years after December 22, 1987, and periodically thereafter, the Secretary shall prepare and transmit to the

400

Committee on Energy and Commerce of the House of Representatives and the Committee on Labor and Human Resources of the Senate a report describing the actions taken pursuant to subsection (a) of this section during the preceding 2−year period. −SOURCE− (July 1, 1944, ch. 373, title XXI, Sec. 2127, as added Pub. L. 99−660, title III, Sec. 311(a), Nov. 14, 1986, 100 Stat. 3777; amended Pub. L. 100−203, title IV, Sec. 4302(b)(1), Dec. 22, 1987, 101 Stat. 1330−221; Pub. L. 101−239, title VI, Sec. 6601(q), Dec. 19, 1989, 103 Stat. 2292.) −COD− CODIFICATION In subsecs. (a)(1), (c), "December 22, 1987" substituted for "the effective date of this subpart" on authority of section 323 of Pub. L. 99−660, as amended, set out as an Effective Date note under section 300aa−1 of this title. −MISC1− AMENDMENTS 1989 − Subsecs. (b), (c). Pub. L. 101−239 added subsec. (b) and redesignated former subsec. (b) as (c). 1987 − Subsecs. (a)(1), (b). Pub. L. 100−203 substituted "effective date of this subpart" for "effective date of this part". −CHANGE− CHANGE OF NAME Centers for Disease Control changed to Centers for Disease Control and Prevention by Pub. L. 102−531, title III, Sec. 312,

401

Oct. 27, 1992, 106 Stat. 3504. Committee on Energy and Commerce of House of Representatives treated as referring to Committee on Commerce of House of Representatives by section 1(a) of Pub. L. 104−14, set out as a note preceding section 21 of Title 2, The Congress. Committee on Commerce of House of Representatives changed to Committee on Energy and Commerce of House of Representatives, and jurisdiction over matters relating to securities and exchanges and insurance generally transferred to Committee on Financial Services of House of Representatives by House Resolution No. 5, One Hundred Seventh Congress, Jan. 3, 2001. −MISC2− EFFECTIVE DATE OF 1989 AMENDMENT For applicability of amendments by Pub. L. 101−239 to petitions filed after Dec. 19, 1989, petitions currently pending in which the evidentiary record is closed, and petitions currently pending in which the evidentiary record is not closed, with provision for an immediate suspension for 30 days of all pending cases, see section 6601(s)(1) of Pub. L. 101−239, set out as a note under section 300aa−10 of this title. −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in section 300aa−19 of this title. −End− −CITE− 42 USC Sec. 300aa−28 01/06/03

402

−EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XIX − VACCINES Part 2 − National Vaccine Injury Compensation Program subpart c − assuring a safer childhood vaccination program in united states −HEAD− Sec. 300aa−28. Manufacturer recordkeeping and reporting −STATUTE− (a) General rule Each vaccine manufacturer of a vaccine set forth in the Vaccine Injury Table or any other vaccine the administration of which is mandated by the law or regulations of any State, shall, with respect to each batch, lot, or other quantity manufactured or licensed after December 22, 1987 − (1) prepare and maintain records documenting the history of the manufacturing, processing, testing, repooling, and reworking of each batch, lot, or other quantity of such vaccine, including the identification of any significant problems encountered in the production, testing, or handling of such batch, lot, or other quantity, (2) if a safety test on such batch, lot, or other quantity indicates a potential imminent or substantial public health hazard is presented, report to the Secretary within 24 hours of such safety test which the manufacturer (or manufacturer's

403

representative) conducted, including the date of the test, the type of vaccine tested, the identity of the batch, lot, or other quantity tested, whether the batch, lot, or other quantity tested is the product of repooling or reworking of previous batches, lots, or other quantities (and, if so, the identity of the previous batches, lots, or other quantities which were repooled or reworked), the complete test results, and the name and address of the person responsible for conducting the test, (3) include with each such report a certification signed by a responsible corporate official that such report is true and complete, and (4) prepare, maintain, and upon request submit to the Secretary product distribution records for each such vaccine by batch, lot, or other quantity number. (b) Sanction Any vaccine manufacturer who intentionally destroys, alters, falsifies, or conceals any record or report required under paragraph (1) or (2) of subsection (a) of this section shall − (1) be subject to a civil penalty of up to $100,000 per occurrence, or (2) be fined $50,000 or imprisoned for not more than 1 year, or both. Such penalty shall apply to the person who intentionally destroyed, altered, falsified, or concealed such record or report, to the person who directed that such record or report be destroyed, altered, falsified, or concealed, and to the vaccine manufacturer

404

for which such person is an agent, employee, or representative. Each act of destruction, alteration, falsification, or concealment shall be treated as a separate occurrence. −SOURCE− (July 1, 1944, ch. 373, title XXI, Sec. 2128, as added Pub. L. 99−660, title III, Sec. 311(a), Nov. 14, 1986, 100 Stat. 3777; amended Pub. L. 100−203, title IV, Sec. 4302(b)(1), Dec. 22, 1987, 101 Stat. 1330−221.) −COD− CODIFICATION In subsec. (a), "December 22, 1987" substituted for "the effective date of this subpart" on authority of section 323 of Pub. L. 99−660, as amended, set out as an Effective Date note under section 300aa−1 of this title. −MISC1− AMENDMENTS 1987 − Subsec. (a). Pub. L. 100−203 substituted "effective date of this subpart" for "effective date of this part". −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in section 300aa−33 of this title. −End− −CITE− 42 USC subpart d − general provisions 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE

405

CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XIX − VACCINES Part 2 − National Vaccine Injury Compensation Program subpart d − general provisions −HEAD− SUBPART D − GENERAL PROVISIONS −End− −CITE− 42 USC Sec. 300aa−31 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XIX − VACCINES Part 2 − National Vaccine Injury Compensation Program subpart d − general provisions −HEAD− Sec. 300aa−31. Citizen's actions −STATUTE− (a) General rule Except as provided in subsection (b) of this section, any person may commence in a district court of the United States a civil action on such person's own behalf against the Secretary where there is alleged a failure of the Secretary to perform any act or duty under this part. (b) Notice No action may be commenced under subsection (a) of this section

406

before the date which is 60 days after the person bringing the action has given written notice of intent to commence such action to the Secretary. (c) Costs of litigation The court, in issuing any final order in any action under this section, may award costs of litigation (including reasonable attorney and expert witness fees) to any plaintiff who substantially prevails on one or more significant issues in the action. −SOURCE− (July 1, 1944, ch. 373, title XXI, Sec. 2131, as added Pub. L. 99−660, title III, Sec. 311(a), Nov. 14, 1986, 100 Stat. 3778; amended Pub. L. 100−203, title IV, Sec. 4305, Dec. 22, 1987, 101 Stat. 1330−224.) −MISC1− AMENDMENTS 1987 − Subsec. (c). Pub. L. 100−203, which directed that subsec. (c) be amended by substituting "to any plaintiff who substantially prevails on one or more significant issues in the action" for "to any party, whenever the court determines that such award is appropriate", was executed by making the substitution for "to any party, whenever the court determines such award is appropriate", to reflect the probable intent of Congress. EFFECTIVE DATE Subpart effective Dec. 22, 1987, see section 323 of Pub. L. 99−660, set out as a note under section 300aa−1 of this title.

407

−End− −CITE− 42 USC Sec. 300aa−32 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XIX − VACCINES Part 2 − National Vaccine Injury Compensation Program subpart d − general provisions −HEAD− Sec. 300aa−32. Judicial review −STATUTE− A petition for review of a regulation under this part may be filed in a court of appeals of the United States within 60 days from the date of the promulgation of the regulation or after such date if such petition is based solely on grounds arising after such 60th day. −SOURCE− (July 1, 1944, ch. 373, title XXI, Sec. 2132, as added Pub. L. 99−660, title III, Sec. 311(a), Nov. 14, 1986, 100 Stat. 3778.) −End− −CITE− 42 USC Sec. 300aa−33 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE

408

SUBCHAPTER XIX − VACCINES Part 2 − National Vaccine Injury Compensation Program subpart d − general provisions −HEAD− Sec. 300aa−33. Definitions −STATUTE− For purposes of this part: (1) The term "health care provider" means any licensed health care professional, organization, or institution, whether public or private (including Federal, State, and local departments, agencies, and instrumentalities) under whose authority a vaccine set forth in the Vaccine Injury Table is administered. (2) The term "legal representative" means a parent or an individual who qualifies as a legal guardian under State law. (3) The term "manufacturer" means any corporation, organization, or institution, whether public or private (including Federal, State, and local departments, agencies, and instrumentalities), which manufactures, imports, processes, or distributes any vaccine set forth in the Vaccine Injury table, including any component or ingredient of any such vaccine, except that, for purposes of section 300aa−28 of this title, such term shall include the manufacturer of any other vaccine covered by that section. The term "manufacture" means to manufacture, import, process, or distribute a vaccine including any component or ingredient of any such vaccine. (4) The term "significant aggravation" means any change for the

409

worse in a preexisting condition which results in markedly greater disability, pain, or illness accompanied by substantial deterioration of health. (5) The term "vaccine−related injury or death" means an illness, injury, condition, or death associated with one or more of the vaccines set forth in the Vaccine Injury Table, except that the term does not include an illness, injury, condition, or death associated with an adulterant or contaminant intentionally added to such a vaccine. For purposes of the preceding sentence, an adulterant or contaminant shall not include any component or ingredient listed in a vaccine's product license application or product label. (6)(A) The term "Advisory Commission on Childhood Vaccines" means the Commission established under section 300aa−19 of this title. (B) The term "Vaccine Injury Table" means the table set out in section 300aa−14 of this title. (7) The term "vaccine" means any preparation or suspension, including but not limited to a preparation or suspension containing an attenuated or inactive microorganism or subunit thereof or toxin, developed or administered to produce or enhance the body's immune response to a disease or diseases and includes all components and ingredients listed in the vaccines's product license application and product label. −SOURCE− (July 1, 1944, ch. 373, title XXI, Sec. 2133, as added Pub. L.

410

99−660, title III, Sec. 311(a), Nov. 14, 1986, 100 Stat. 3778; amended Pub. L. 107−296, title XVII, Secs. 1714−1716, Nov. 25, 2002, 116 Stat. 2320, 2321.) −MISC1− AMENDMENTS 2002 − Par. (3). Pub. L. 107−296, Sec. 1714, in first sentence, substituted "any vaccine set forth in the Vaccine Injury table, including any component or ingredient of any such vaccine" for "under its label any vaccine set forth in the Vaccine Injury Table" and, in second sentence, inserted "including any component or ingredient of any such vaccine" before period at end. Par. (5). Pub. L. 107−296, Sec. 1715, inserted at end "For purposes of the preceding sentence, an adulterant or contaminant shall not include any component or ingredient listed in a vaccine's product license application or product label." Par. (7). Pub. L. 107−296, Sec. 1716, added par. (7). EFFECTIVE DATE OF 2002 AMENDMENT Pub. L. 107−296, title XVII, Sec. 1717, Nov. 25, 2002, 116 Stat. 2321, provided that: "The amendments made by sections 1714, 1715, and 1716 [amending this section] shall apply to all actions or proceedings pending on or after the date of enactment of this Act [Nov. 25, 2002], unless a court of competent jurisdiction has entered judgment (regardless of whether the time for appeal has expired) in such action or proceeding disposing of the entire action or proceeding." −End−

411

−CITE− 42 USC Sec. 300aa−34 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XIX − VACCINES Part 2 − National Vaccine Injury Compensation Program subpart d − general provisions −HEAD− Sec. 300aa−34. Termination of program −STATUTE− (a) Reviews The Secretary shall review the number of awards of compensation made under the program to petitioners under section 300aa−11 of this title for vaccine−related injuries and deaths associated with the administration of vaccines on or after December 22, 1987, as follows: (1) The Secretary shall review the number of such awards made in the 12−month period beginning on December 22, 1987. (2) At the end of each 3−month period beginning after the expiration of the 12−month period referred to in paragraph (1) the Secretary shall review the number of such awards made in the 3−month period. (b) Report (1) If in conducting a review under subsection (a) of this section the Secretary determines that at the end of the period

412

reviewed the total number of awards made by the end of that period and accepted under section 300aa−21(a) of this title exceeds the number of awards listed next to the period reviewed in the table in paragraph (2) − (A) the Secretary shall notify the Congress of such determination, and (B) beginning 180 days after the receipt by Congress of a notification under paragraph (1), no petition for a vaccine−related injury or death associated with the administration of a vaccine on or after December 22, 1987, may be filed under section 300aa−11 of this title. Section 300aa−11(a) of this title and subpart B of this part shall not apply to civil actions for damages for a vaccine−related injury or death for which a petition may not be filed because of subparagraph (B). (2) The table referred to in paragraph (1) is as follows: Total number of awards by the end of the period Period reviewed: reviewed 12 months after December 22, 1987 150 13th through the 15th month after December 22, 1987 188 16th through the 18th month after December 22, 1987 225

413

19th through the 21st month after December 22, 1987 263 22nd through the 24th month after December 22, 1987 300 25th through the 27th month after December 22, 1987 338 28th through the 30th month after December 22, 1987 375 31st through the 33rd month after December 22, 1987 413 34th through the 36th month after December 22, 1987 450 37th through the 39th month after December 22, 1987 488 40th through the 42nd month after December 22, 1987 525 43rd through the 45th month after December 22, 1987 563 46th through the 48th month after December 22, 1987 600. −SOURCE− (July 1, 1944, ch. 373, title XXI, Sec. 2134, as added Pub. L. 100−203, title IV, Sec. 4303(f), Dec. 22, 1987, 101 Stat. 1330−222.) −COD− CODIFICATION

414

In subsecs. (a) and (b), "December 22, 1987" substituted for "the effective date of this subpart" on authority of section 323 of Pub. L. 99−660, as amended, set out as an Effective Date note under section 300aa−1 of this title. −End− −CITE− 42 USC SUBCHAPTER XX − REQUIREMENTS FOR CERTAIN GROUP HEALTH PLANS FOR CERTAIN STATE AND LOCAL EMPLOYEES 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XX − REQUIREMENTS FOR CERTAIN GROUP HEALTH PLANS FOR CERTAIN STATE AND LOCAL EMPLOYEES −HEAD− SUBCHAPTER XX − REQUIREMENTS FOR CERTAIN GROUP HEALTH PLANS FOR CERTAIN STATE AND LOCAL EMPLOYEES −SECREF− SUBCHAPTER REFERRED TO IN OTHER SECTIONS This subchapter is referred to in sections 300gg−91, 1396a, 1396e of this title; title 26 section 9832; title 29 section 1191b. −End− −CITE− 42 USC Sec. 300bb−1 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE

415

CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XX − REQUIREMENTS FOR CERTAIN GROUP HEALTH PLANS FOR CERTAIN STATE AND LOCAL EMPLOYEES −HEAD− Sec. 300bb−1. State and local governmental group health plans must provide continuation coverage to certain individuals −STATUTE− (a) In general In accordance with regulations which the Secretary shall prescribe, each group health plan that is maintained by any State that receives funds under this chapter, by any political subdivision of such a State, or by any agency or instrumentality of such a State or political subdivision, shall provide, in accordance with this subchapter, that each qualified beneficiary who would lose coverage under the plan as a result of a qualifying event is entitled, under the plan, to elect, within the election period, continuation coverage under the plan. (b) Exception for certain plans Subsection (a) of this section shall not apply to − (1) any group health plan for any calendar year if all employers maintaining such plan normally employed fewer than 20 employees on a typical business day during the preceding calendar year, or (2) any group health plan maintained for employees by the government of the District of Columbia or any territory or possession of the United States or any agency or instrumentality.

416

−SOURCE− (July 1, 1944, ch. 373, title XXII, Sec. 2201, as added Pub. L. 99−272, title X, Sec. 10003(a), Apr. 7, 1986, 100 Stat. 232; amended Pub. L. 101−239, title VI, Sec. 6801(a)(1), Dec. 19, 1989, 103 Stat. 2296.) −MISC1− AMENDMENTS 1989 − Subsec. (b). Pub. L. 101−239 struck out at end "Under regulations, rules similar to the rules of subsections (a) and (b) of section 52 of title 26 (relating to employers under common control) shall apply for purposes of paragraph (1)." EFFECTIVE DATE OF 1989 AMENDMENT Section 6801(a)(2) of Pub. L. 101−239 provided that: "The amendment made by paragraph (1) [amending this section] shall apply to years beginning after December 31, 1986." EFFECTIVE DATE Section 10003(b) of Pub. L. 99−272 provided that: "(1) General rule. − The amendments made by this section [enacting this subchapter] shall apply to plan years beginning on or after July 1, 1986. "(2) Special rule for collective bargaining agreements. − In the case of a group health plan maintained pursuant to one or more collective bargaining agreements between employee representatives and one or more employers ratified before the date of the enactment of this Act [Apr. 7, 1986], the amendments made by this section shall not apply to plan years beginning before the later of −

417

"(A) the date on which the last of the collective bargaining agreements relating to the plan terminates (determined without regard to any extension thereof agreed to after the date of the enactment of this Act), or "(B) January 1, 1987. For purposes of subparagraph (A), any plan amendment made pursuant to a collective bargaining agreement relating to the plan which amends the plan solely to conform to any requirement added by this section shall not be treated as a termination of such collective bargaining agreement." −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in section 300bb−2 of this title. −End− −CITE− 42 USC Sec. 300bb−2 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XX − REQUIREMENTS FOR CERTAIN GROUP HEALTH PLANS FOR CERTAIN STATE AND LOCAL EMPLOYEES −HEAD− Sec. 300bb−2. Continuation coverage −STATUTE− For purposes of section 300bb−1 of this title, the term "continuation coverage" means coverage under the plan which meets

418

the following requirements: (1) Type of benefit coverage The coverage must consist of coverage which, as of the time the coverage is being provided, is identical to the coverage provided under the plan to similarly situated beneficiaries under the plan with respect to whom a qualifying event has not occurred. If coverage is modified under the plan for any group of similarly situated beneficiaries, such coverage shall also be modified in the same manner for all individuals who are qualified beneficiaries under the plan pursuant to this part (!1) in connection with such group. (2) Period of coverage The coverage must extend for at least the period beginning on the date of the qualifying event and ending not earlier than the earliest of the following: (A) Maximum required period (i) General rule for terminations and reduced hours In the case of a qualifying event described in section 300bb−3(2) of this title, except as provided in clause (ii), the date which is 18 months after the date of the qualifying event. (ii) Special rule for multiple qualifying events If a qualifying event occurs during the 18 months after the date of a qualifying event described in section 300bb−3(2) of this title, the date which is 36 months after the date of the qualifying event described in section 300bb−3(2) of this

419

title. (iii) General rule for other qualifying events In the case of a qualifying event not described in section 300bb−3(2) of this title, the date which is 36 months after the date of the qualifying event. (iv) Medicare entitlement followed by qualifying event In the case of a qualifying event described in section 300bb−3(2) of this title that occurs less than 18 months after the date the covered employee became entitled to benefits under title XVIII of the Social Security Act [42 U.S.C. 1395 et seq.], the period of coverage for qualified beneficiaries other than the covered employee shall not terminate under this subparagraph before the close of the 36−month period beginning on the date the covered employee became so entitled. In the case of a qualified beneficiary who is determined, under title II or XVI of the Social Security Act [42 U.S.C. 401 et seq., 1381 et seq.], to have been disabled at any time during the first 60 days of continuation coverage under this subchapter, any reference in clause (i) or (ii) to 18 months is deemed a reference to 29 months (with respect to all qualified beneficiaries), but only if the qualified beneficiary has provided notice of such determination under section 300bb−6(3) of this title before the end of such 18 months. (B) End of plan The date on which the employer ceases to provide any group

420

health plan to any employee. (C) Failure to pay premium The date on which coverage ceases under the plan by reason of a failure to make timely payment of any premium required under the plan with respect to the qualified beneficiary. The payment of any premium (other than any payment referred to in the last sentence of paragraph (3)) shall be considered to be timely if made within 30 days after the date due or within such longer period as applies to or under the plan. (D) Group health plan coverage or medicare entitlement The date on which the qualified beneficiary first becomes, after the date of the election − (i) covered under any other group health plan (as an employee or otherwise) which does not contain any exclusion or limitation with respect to any preexisting condition of such beneficiary (other than such an exclusion or limitation which does not apply to (or is satisfied by) such beneficiary by reason of chapter 100 of title 26, part 7 of subtitle B of title I of the Employee Retirement Income Security Act of 1974 [29 U.S.C. 1181 et seq.], or subchapter XXV of this chapter), or (ii) entitled to benefits under title XVIII of the Social Security Act [42 U.S.C. 1395 et seq.]. (E) Termination of extended coverage for disability In the case of a qualified beneficiary who is disabled at any time during the first 60 days of continuation coverage under

421

this subchapter, the month that begins more than 30 days after the date of the final determination under title II or XVI of the Social Security Act [42 U.S.C. 401 et seq., 1381 et seq.] that the qualified beneficiary is no longer disabled. (3) Premium requirements The plan may require payment of a premium for any period of continuation coverage, except that such premium − (A) shall not exceed 102 percent of the applicable premium for such period, and (B) may, at the election of the payor, be made in monthly installments. In no event may the plan require the payment of any premium before the day which is 45 days after the day on which the qualified beneficiary made the initial election for continuation coverage.(!2) In the case of an individual described in the last sentence of paragraph (2)(A), any reference in subparagraph (A) of this paragraph to "102 percent" is deemed a reference to "150 percent" for any month after the 18th month of continuation coverage described in clause (i) or (ii) of paragraph (2)(A). (4) No requirement of insurability The coverage may not be conditioned upon, or discriminate on the basis of lack of, evidence of insurability. (5) Conversion option In the case of a qualified beneficiary whose period of continuation coverage expires under paragraph (2)(A), the plan must, during the 180−day period ending on such expiration date,

422

provide to the qualified beneficiary the option of enrollment under a conversion health plan otherwise generally available under the plan. −SOURCE− (July 1, 1944, ch. 373, title XXII, Sec. 2202, as added Pub. L. 99−272, title X, Sec. 10003(a), Apr. 7, 1986, 100 Stat. 233; amended Pub. L. 99−514, title XVIII, Sec. 1895(d)(1)(C), (2)(C), (3)(C), (4)(C), Oct. 22, 1986, 100 Stat. 2937−2939; Pub. L. 101−239, title VI, Secs. 6702(a), (b), 6801(b)(1)(A), (2)(A), (3)(A), Dec. 19, 1989, 103 Stat. 2295, 2297; Pub. L. 104−188, title I, Sec. 1704(g)(1)(C), Aug. 20, 1996, 110 Stat. 1880; Pub. L. 104−191, title IV, Sec. 421(a)(1), Aug. 21, 1996, 110 Stat. 2087.) −REFTEXT− REFERENCES IN TEXT The Social Security Act, referred to in par. (2)(A), (D)(ii), and (E), is act Aug. 14, 1935, ch. 531, 49 Stat. 620, as amended. Titles II, XVI, and XVIII of the Social Security Act are classified generally to subchapters II (Sec. 401 et seq.), XVI (Sec. 1381 et seq.), and XVIII (Sec. 1395 et seq.), respectively, of chapter 7 of this title. For complete classification of this Act to the Code, see section 1305 of this title and Tables. The Employee Retirement Income Security Act of 1974, referred to in par. (2)(D)(i), is Pub. L. 93−406, Sept. 2, 1974, 88 Stat. 829, as amended. Part 7 of subtitle B of title I of the Act is classified generally to part 7 (Sec. 1181 et seq.) of subtitle B of subchapter I of chapter 18 of Title 29, Labor. For complete

423

classification of this Act to the Code, see Short Title note set out under section 1001 of Title 29 and Tables. −MISC1− AMENDMENTS 1996 − Par. (2)(A). Pub. L. 104−191, Sec. 421(a)(1)(A)(ii)(IV), inserted "(with respect to all qualified beneficiaries)" after "29 months" in concluding provisions. Pub. L. 104−191, Sec. 421(a)(1)(A)(ii)(III), which directed amendment of concluding provisions by striking "with respect to such event,", was executed by striking that phrase, which did not contain a comma at end, before "is deemed a reference" to reflect the probable intent of Congress. Pub. L. 104−191, Sec. 421(a)(1)(A)(ii)(I), (II), in concluding provisions, substituted "a qualified beneficiary" for "an individual" and "at any time during the first 60 days of continuation coverage under this subchapter" for "at the time of a qualifying event described in section 300bb−3(2) of this title". Pub. L. 104−191, Sec. 421(a)(1)(A)(i), transferred sentence following cl. (iii) to appear as concluding provisions following cl. (iv). Par. (2)(A)(iv). Pub. L. 104−188 amended heading and text of cl. (iv) generally. Prior to amendment, text read as follows: "In the case of an event described in section 300bb−3(4) of this title (without regard to whether such event is a qualifying event), the period of coverage for qualified beneficiaries other than the covered employee for such event or any subsequent qualifying event

424

shall not terminate before the close of the 36−month period beginning on the date the covered employee becomes entitled to benefits under title XVIII of the Social Security Act." Par. (2)(D)(i). Pub. L. 104−191, Sec. 421(a)(1)(B), inserted "(other than such an exclusion or limitation which does not apply to (or is satisfied by) such beneficiary by reason of chapter 100 of title 26, part 7 of subtitle B of title I of the Employee Retirement Income Security Act of 1974, or subchapter XXV of this chapter)" before ", or". Par. (2)(E). Pub. L. 104−191, Sec. 421(a)(1)(C), substituted "at any time during the first 60 days of continuation coverage under this subchapter" for "at the time of a qualifying event described in section 300bb−3(2) of this title". 1989 − Par. (2)(A). Pub. L. 101−239, Sec. 6702(a)(1), inserted after cl. (iii) "In the case of an individual who is determined, under title II or XVI of the Social Security Act, to have been disabled at the time of a qualifying event described in section 300bb−3(2) of this title, any reference in clause (i) or (ii) to 18 months with respect to such event is deemed a reference to 29 months, but only if the qualified beneficiary has provided notice of such determination under section 300bb−6(3) of this title before the end of such 18 months." Par. (2)(A)(iv). Pub. L. 101−239, Sec. 6801(b)(1)(A), added cl. (iv). Par. (2)(D). Pub. L. 101−239, Sec. 6801(b)(2)(A), substituted "entitlement" for "eligibility" in heading and inserted "which does

425

not contain any exclusion or limitation with respect to any preexisting condition of such beneficiary" after "or otherwise)" in cl. (i). Par. (2)(E). Pub. L. 101−239, Sec. 6702(a)(2), added subpar. (E). Par. (3). Pub. L. 101−239, Sec. 6801(b)(3)(A), which directed the general amendment of the concluding provision was executed by amending the first sentence of the concluding provision generally to reflect the probable intent of Congress and amendment of concluding provision by Pub. L. 101−239, Sec. 6702(b). Prior to amendment, first sentence of the concluding provision read as follows: "If an election is made after the qualifying event, the plan shall permit payment for continuation coverage during the period preceding the election to be made within 45 days of the date of the election." Pub. L. 101−239, Sec. 6702(b), inserted at end of concluding provision "In the case of an individual described in the last sentence of paragraph (2)(A), any reference in subparagraph (A) of this paragraph to '102 percent' is deemed a reference to '150 percent' for any month after the 18th month of continuation coverage described in clause (i) or (ii) of paragraph (2)(A)." See Amendment note above. 1986 − Par. (1). Pub. L. 99−514, Sec. 1895(d)(1)(C), inserted at end "If coverage is modified under the plan for any group of similarly situated beneficiaries, such coverage shall also be modified in the same manner for all individuals who are qualified beneficiaries under the plan pursuant to this part in connection

426

with such group." Par. (2)(A). Pub. L. 99−514, Sec. 1895(d)(2)(C), amended subpar. (A) generally. Prior to amendment, subpar. (A) read as follows: "Maximum period. − In the case of − "(i) a qualifying event described in section 300bb−3(2) of this title (relating to terminations and reduced hours), the date which is 18 months after the date of the qualifying event, and "(ii) any qualifying event not described in clause (i), the date which is 36 months after the date of the qualifying event." Par. (2)(C). Pub. L. 99−514, Sec. 1895(d)(3)(C), inserted at end "The payment of any premium (other than any payment referred to in the last sentence of paragraph (3)) shall be considered to be timely if made within 30 days after the date due or within such longer period as applies to or under the plan." Par. (2)(D). Pub. L. 99−514, Sec. 1895(d)(4)(C)(ii), (iii), substituted "Group health plan coverage" for "Reemployment" in heading, added cl. (i), and struck out former cl. (i) which read as follows: "a covered employee under any other group health plan, or". Par. (2)(E). Pub. L. 99−514, Sec. 1895(d)(4)(C)(i), struck out subpar. (E), remarriage of spouse, which read as follows: "In the case of an individual who is a qualified beneficiary by reason of being the spouse of a covered employee, the date on which the beneficiary remarries and becomes covered under a group health plan." EFFECTIVE DATE OF 1996 AMENDMENTS

427

Amendment by Pub. L. 104−191 effective Jan. 1, 1997, regardless of whether the qualifying event occurred before, on, or after such date, see section 421(d) of Pub. L. 104−191, set out as a note under section 4980B of Title 26, Internal Revenue Code. Amendment by Pub. L. 104−188 applicable to plan years beginning after Dec. 31, 1989, see section 1704(g)(2) of Pub. L. 104−188, set out as a note under section 4980B of Title 26. EFFECTIVE DATE OF 1989 AMENDMENT Section 6702(d) of Pub. L. 101−239 provided that: "The amendments made by this section [amending this section and section 300bb−6 of this title] shall apply to plan years beginning on or after the date of the enactment of this Act [Dec. 19, 1989], regardless of whether the qualifying event occurred before, on, or after such date." Section 6801(b)(1)(B) of Pub. L. 101−239 provided that: "The amendments made by this paragraph [amending this section] shall apply to plan years beginning after December 31, 1989." Section 6801(b)(2)(B) of Pub. L. 101−239 provided that: "The amendments made by subparagraph (A) [amending this section] shall apply to − "(i) qualifying events occurring after December 31, 1989, and "(ii) in the case of qualified beneficiaries who elected continuation coverage after December 31, 1988, the period for which the required premium was paid (or was attempted to be paid but was rejected as such)." Section 6801(b)(3)(B) of Pub. L. 101−239 provided that: "The

428

amendment made by subparagraph (A) [amending this section] shall apply to plan years beginning after December 31, 1989." EFFECTIVE DATE OF 1986 AMENDMENT Amendment by Pub. L. 99−514 effective, except as otherwise provided, as if included in enactment of the Consolidated Omnibus Budget Reconciliation Act of 1985, Pub. L. 99−272, see section 1895(e) of Pub. L. 99−514, set out as a note under section 162 of Title 26, Internal Revenue Code. PLAN AMENDMENTS NOT REQUIRED UNTIL JANUARY 1, 1989 For provisions directing that if any amendments made by subtitle A or subtitle C of title XI [Secs. 1101−1147 and 1171−1177] or title XVIII [Secs. 1800−1899A] of Pub. L. 99−514 require an amendment to any plan, such plan amendment shall not be required to be made before the first plan year beginning on or after Jan. 1, 1989, see section 1140 of Pub. L. 99−514, as amended, set out as a note under section 401 of Title 26, Internal Revenue Code. −FOOTNOTE− (!1) So in original. This subchapter is not divided into parts. (!2) See 1989 Amendment note below. −End− −CITE− 42 USC Sec. 300bb−3 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XX − REQUIREMENTS FOR CERTAIN GROUP HEALTH PLANS FOR

429

CERTAIN STATE AND LOCAL EMPLOYEES −HEAD− Sec. 300bb−3. Qualifying event −STATUTE− For purposes of this subchapter, the term "qualifying event" means, with respect to any covered employee, any of the following events which, but for the continuation coverage required under this subchapter, would result in the loss of coverage of a qualified beneficiary: (1) The death of the covered employee. (2) The termination (other than by reason of such employee's gross misconduct), or reduction of hours, of the covered employee's employment. (3) The divorce or legal separation of the covered employee from the employee's spouse. (4) The covered employee becoming entitled to benefits under title XVIII of the Social Security Act [42 U.S.C. 1395 et seq.]. (5) A dependent child ceasing to be a dependent child under the generally applicable requirements of the plan. −SOURCE− (July 1, 1944, ch. 373, title XXII, Sec. 2203, as added Pub. L. 99−272, title X, Sec. 10003(a), Apr. 7, 1986, 100 Stat. 234.) −REFTEXT− REFERENCES IN TEXT The Social Security Act, referred to in par. (4), is act Aug. 14, 1935, ch. 531, 49 Stat. 620, as amended. Title XVIII of the Social

430

Security Act is classified generally to subchapter XVIII (Sec. 1395 et seq.) of chapter 7 of this title. For complete classification of this Act to the Code, see section 1305 of this title and Tables. −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in sections 300bb−2, 300bb−6, 300bb−8 of this title. −End− −CITE− 42 USC Sec. 300bb−4 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XX − REQUIREMENTS FOR CERTAIN GROUP HEALTH PLANS FOR CERTAIN STATE AND LOCAL EMPLOYEES −HEAD− Sec. 300bb−4. Applicable premium −STATUTE− For purposes of this subchapter − (1) In general The term "applicable premium" means, with respect to any period of continuation coverage of qualified beneficiaries, the cost to the plan for such period of the coverage for similarly situated beneficiaries with respect to whom a qualifying event has not occurred (without regard to whether such cost is paid by the employer or employee).

431

(2) Special rule for self−insured plans To the extent that a plan is a self−insured plan − (A) In general Except as provided in subparagraph (B), the applicable premium for any period of continuation coverage of qualified beneficiaries shall be equal to a reasonable estimate of the cost of providing coverage for such period for similarly situated beneficiaries which − (i) is determined on an actuarial basis, and (ii) takes into account such factors as the Secretary may prescribe in regulations. (B) Determination on basis of past cost If a plan administrator elects to have this subparagraph apply, the applicable premium for any period of continuation coverage of qualified beneficiaries shall be equal to − (i) the cost to the plan for similarly situated beneficiaries for the same period occurring during the preceding determination period under paragraph (3), adjusted by (ii) the percentage increase or decrease in the implicit price deflator of the gross national product (calculated by the Department of Commerce and published in the Survey of Current Business) for the 12−month period ending on the last day of the sixth month of such preceding determination period. (C) Subparagraph (B) not to apply where significant change

432

A plan administrator may not elect to have subparagraph (B) apply in any case in which there is any significant difference, between the determination period and the preceding determination period, in coverage under, or in employees covered by, the plan. The determination under the preceding sentence for any determination period shall be made at the same time as the determination under paragraph (3). (3) Determination period The determination of any applicable premium shall be made for a period of 12 months and shall be made before the beginning of such period. −SOURCE− (July 1, 1944, ch. 373, title XXII, Sec. 2204, as added Pub. L. 99−272, title X, Sec. 10003(a), Apr. 7, 1986, 100 Stat. 234.) −End− −CITE− 42 USC Sec. 300bb−5 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XX − REQUIREMENTS FOR CERTAIN GROUP HEALTH PLANS FOR CERTAIN STATE AND LOCAL EMPLOYEES −HEAD− Sec. 300bb−5. Election −STATUTE− (a) In general

433

For purposes of this subchapter − (1) Election period The term "election period" means the period which − (A) begins not later than the date on which coverage terminates under the plan by reason of a qualifying event, (B) is of at least 60 days' duration, and (C) ends not earlier than 60 days after the later of − (i) the date described in subparagraph (A), or (ii) in the case of any qualified beneficiary who receives notice under section 300bb−6(4) of this title, the date of such notice. (2) Effect of election on other beneficiaries Except as otherwise specified in an election, any election of continuation coverage by a qualified beneficiary described in subparagraph (A)(i) or (B) of section 300bb−8(3) of this title shall be deemed to include an election of continuation coverage on behalf of any other qualified beneficiary who would lose coverage under the plan by reason of the qualifying event. If there is a choice among types of coverage under the plan, each qualified beneficiary is entitled to make a separate selection among such types of coverage. (b) Temporary extension of COBRA election period for certain individuals (1) In general In the case of a nonelecting TAA−eligible individual and notwithstanding subsection (a) of this section, such individual

434

may elect continuation coverage under this subchapter during the 60−day period that begins on the first day of the month in which the individual becomes a TAA−eligible individual, but only if such election is made not later than 6 months after the date of the TAA−related loss of coverage. (2) Commencement of coverage; no reach−back Any continuation coverage elected by a TAA−eligible individual under paragraph (1) shall commence at the beginning of the 60−day election period described in such paragraph and shall not include any period prior to such 60−day election period. (3) Preexisting conditions With respect to an individual who elects continuation coverage pursuant to paragraph (1), the period − (A) beginning on the date of the TAA−related loss of coverage, and (B) ending on the first day of the 60−day election period described in paragraph (1), shall be disregarded for purposes of determining the 63−day periods referred to in section 300gg(c)(2) of this title, section 1181(c)(2) of title 29, and section 9801(c)(2) of title 26. (4) Definitions For purposes of this subsection: (A) Nonelecting TAA−eligible individual The term "nonelecting TAA−eligible individual" means a TAA−eligible individual who − (i) has a TAA−related loss of coverage; and

435

(ii) did not elect continuation coverage under this part (!1) during the TAA−related election period. (B) TAA−eligible individual The term "TAA−eligible individual" means − (i) an eligible TAA recipient (as defined in paragraph (2) of section 35(c) of title 26), and (ii) an eligible alternative TAA recipient (as defined in paragraph (3) of such section). (C) TAA−related election period The term "TAA−related election period" means, with respect to a TAA−related loss of coverage, the 60−day election period under this part (!1) which is a direct consequence of such loss. (D) TAA−related loss of coverage The term "TAA−related loss of coverage" means, with respect to an individual whose separation from employment gives rise to being an TAA−eligible individual, the loss of health benefits coverage associated with such separation. −SOURCE− (July 1, 1944, ch. 373, title XXII, Sec. 2205, as added Pub. L. 99−272, title X, Sec. 10003(a), Apr. 7, 1986, 100 Stat. 235; amended Pub. L. 99−514, title XVIII, Sec. 1895(d)(5)(C), Oct. 22, 1986, 100 Stat. 2939; Pub. L. 107−210, div. A, title II, Sec. 203(e)(2), Aug. 6, 2002, 116 Stat. 970.) −MISC1− AMENDMENTS

436

2002 − Pub. L. 107−210 designated existing provisions as subsec. (a), inserted subsec. heading, and added subsec. (b). 1986 − Par. (2). Pub. L. 99−514 inserted "of continuation coverage" after "any election" and inserted at end "If there is a choice among types of coverage under the plan, each qualified beneficiary is entitled to make a separate selection among such types of coverage.". EFFECTIVE DATE OF 1986 AMENDMENT Amendment by Pub. L. 99−514 effective, except as otherwise provided, as if included in enactment of the Consolidated Omnibus Budget Reconciliation Act of 1985, Pub. L. 99−272, see section 1895(e) of Pub. L. 99−514, set out as a note under section 162 of Title 26, Internal Revenue Code. CONSTRUCTION OF 2002 AMENDMENT Nothing in amendment by Pub. L. 107−210, other than provisions relating to COBRA continuation coverage and reporting requirements, to be construed as creating new mandate on any party regarding health insurance coverage, see section 203(f) of Pub. L. 107−210, set out as a note under section 2918 of Title 29, Labor. PLAN AMENDMENTS NOT REQUIRED UNTIL JANUARY 1, 1989 For provisions directing that if any amendments made by subtitle A or subtitle C of title XI [Secs. 1101−1147 and 1171−1177] or title XVIII [Secs. 1800−1899A] of Pub. L. 99−514 require an amendment to any plan, such plan amendment shall not be required to be made before the first plan year beginning on or after Jan. 1, 1989, see section 1140 of Pub. L. 99−514, as amended, set out as a

437

note under section 401 of Title 26, Internal Revenue Code. −FOOTNOTE− (!1) So in original. This subchapter is not divided into parts. −End− −CITE− 42 USC Sec. 300bb−6 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XX − REQUIREMENTS FOR CERTAIN GROUP HEALTH PLANS FOR CERTAIN STATE AND LOCAL EMPLOYEES −HEAD− Sec. 300bb−6. Notice requirements −STATUTE− In accordance with regulations prescribed by the Secretary − (1) the group health plan shall provide, at the time of commencement of coverage under the plan, written notice to each covered employee and spouse of the employee (if any) of the rights provided under this subsection,(!1) (2) the employer of an employee under a plan must notify the plan administrator of a qualifying event described in paragraph (1), (2), or (4) of section 300bb−3 of this title within 30 days of the date of the qualifying event, (3) each covered employee or qualified beneficiary is responsible for notifying the plan administrator of the occurrence of any qualifying event described in paragraph (3) or

438

(5) of section 300bb−3 of this title within 60 days after the date of the qualifying event and each qualified beneficiary who is determined, under title II or XVI of the Social Security Act [42 U.S.C. 401 et seq., 1381 et seq.], to have been disabled at any time during the first 60 days of continuation coverage under this subchapter is responsible for notifying the plan administrator of such determination within 60 days after the date of the determination and for notifying the plan administrator within 30 days after the date of any final determination under such title or titles that the qualified beneficiary is no longer disabled, and (4) the plan administrator shall notify − (A) in the case of a qualifying event described in paragraph (1), (2), or (4) of section 300bb−3 of this title, any qualified beneficiary with respect to such event, and (B) in the case of a qualifying event described in paragraph (3) or (5) of section 300bb−3 of this title where the covered employee notifies the plan administrator under paragraph (3), any qualified beneficiary with respect to such event, of such beneficiary's rights under this subsection.(!1) For purposes of paragraph (4), any notification shall be made within 14 days of the date on which the plan administrator is notified under paragraph (2) or (3), whichever is applicable, and any such notification to an individual who is a qualified beneficiary as the spouse of the covered employee shall be treated as notification to all other qualified beneficiaries residing with

439

such spouse at the time such notification is made. −SOURCE− (July 1, 1944, ch. 373, title XXII, Sec. 2206, as added Pub. L. 99−272, title X, Sec. 10003(a), Apr. 7, 1986, 100 Stat. 235; amended Pub. L. 99−514, title XVIII, Sec. 1895(d)(6)(C), Oct. 22, 1986, 100 Stat. 2939; Pub. L. 100−203, title IV, Sec. 4009(j)(8), Dec. 22, 1987, 101 Stat. 1330−59; Pub. L. 101−239, title VI, Sec. 6702(c), Dec. 19, 1989, 103 Stat. 2295; Pub. L. 104−191, title IV, Sec. 421(a)(2), Aug. 21, 1996, 110 Stat. 2088.) −REFTEXT− REFERENCES IN TEXT The Social Security Act, referred to in par. (3), is act Aug. 14, 1935, ch. 531, 49 Stat. 620, as amended. Titles II and XVI of the Social Security Act are classified generally to subchapters II (Sec. 401 et seq.) and XVI (Sec. 1381 et seq.), respectively, of chapter 7 of this title. For complete classification of this Act to the Code, see section 1305 of this title and Tables. −MISC1− AMENDMENTS 1996 − Par. (3). Pub. L. 104−191 substituted "at any time during the first 60 days of continuation coverage under this subchapter" for "at the time of a qualifying event described in section 300bb−3(2) of this title". 1989 − Par. (3). Pub. L. 101−239 inserted "and each qualified beneficiary who is determined, under title II or XVI of the Social Security Act, to have been disabled at the time of a qualifying

440

event described in section 300bb−3(2) of this title is responsible for notifying the plan administrator of such determination within 60 days after the date of the determination and for notifying the plan administrator within 30 days after the date of any final determination under such title or titles that the qualified beneficiary is no longer disabled" after "date of the qualifying event". 1987 − Par. (3). Pub. L. 100−203 amended directory language of Pub. L. 99−514, see 1986 Amendment note below. 1986 − Par. (3). Pub. L. 99−514, as amended by Pub. L. 100−203, inserted "within 60 days after the date of the qualifying event". EFFECTIVE DATE OF 1996 AMENDMENT Amendment by Pub. L. 104−191 effective Jan. 1, 1997, regardless of whether the qualifying event occurred before, on, or after such date, see section 421(d) of Pub. L. 104−191, set out as a note under section 4980B of Title 26, Internal Revenue Code. EFFECTIVE DATE OF 1989 AMENDMENT Amendment by Pub. L. 101−239 applicable to plan years beginning on or after Dec. 19, 1989, regardless of whether the qualifying event occurred before, on, or after such date, see section 6702(d) of Pub. L. 101−239, set out as a note under section 300bb−2 of this title. EFFECTIVE DATE OF 1987 AMENDMENT Section 4009(j)(8) of Pub. L. 100−203 provided that the amendment made by that section is effective as if included in Pub. L. 99−514. EFFECTIVE DATE OF 1986 AMENDMENT

441

Amendment by Pub. L. 99−514 applicable only with respect to qualifying events occurring after Oct. 22, 1986, see section 1895(d)(6)(D) of Pub. L. 99−514, set out as a note under section 162 of Title 26, Internal Revenue Code. NOTIFICATION TO COVERED EMPLOYEES Section 10003(c) of Pub. L. 99−272 provided that: "At the time that the amendments made by this section [enacting this subchapter] apply to a group health plan (covered under section 2201 of the Public Health Service Act [section 300bb−1 of this title]), the plan shall notify each covered employee, and spouse of the employee (if any), who is covered under the plan at that time of the continuation coverage required under title XXII of such Act [this subchapter]. The notice furnished under this subsection is in lieu of notice that may otherwise be required under section 2206(1) of such Act [par. (1) of this section] with respect to such individuals." −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in sections 300bb−2, 300bb−5 of this title. −FOOTNOTE− (!1) So in original. Probably should be "subchapter". −End− −CITE− 42 USC Sec. 300bb−7 01/06/03 −EXPCITE−

442

TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XX − REQUIREMENTS FOR CERTAIN GROUP HEALTH PLANS FOR CERTAIN STATE AND LOCAL EMPLOYEES −HEAD− Sec. 300bb−7. Enforcement −STATUTE− Any individual who is aggrieved by the failure of a State, political subdivision, or agency or instrumentality thereof, to comply with the requirements of this subchapter may bring an action for appropriate equitable relief. −SOURCE− (July 1, 1944, ch. 373, title XXII, Sec. 2207, as added Pub. L. 99−272, title X, Sec. 10003(a), Apr. 7, 1986, 100 Stat. 236.) −MISC1− CONTINUED COVERAGE OF COSTS OF PEDIATRIC VACCINE UNDER CERTAIN GROUP HEALTH PLANS Pub. L. 103−66, title XIII, Sec. 13631(d), Aug. 10, 1993, 107 Stat. 643, provided that: "(1) Requirement. − The requirement of this paragraph, with respect to a group health plan for plan years beginning after the date of the enactment of this Act [Aug. 10, 1993], is that the group health plan not reduce its coverage of the costs of pediatric vaccines (as defined under section 1928(h)(6) of the Social Security Act [section 1396s(h)(6) of this title]) below the coverage it provided as of May 1, 1993.

443

"(2) Enforcement. − For purposes of section 2207 of the Public Health Service Act [this section], the requirement of paragraph (1) is deemed a requirement of title XXII of such Act [this subchapter]." −End− −CITE− 42 USC Sec. 300bb−8 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XX − REQUIREMENTS FOR CERTAIN GROUP HEALTH PLANS FOR CERTAIN STATE AND LOCAL EMPLOYEES −HEAD− Sec. 300bb−8. Definitions −STATUTE− For purposes of this subchapter − (1) Group health plan The term "group health plan" has the meaning given such term in 5000(b) (!1) of title 26. Such term shall not include any plan substantially all of the coverage under which is for qualified long−term care services (as defined in section 7702B(c) of title 26). (2) Covered employee The term "covered employee" means an individual who is (or was) provided coverage under a group health plan by virtue of the performance of services by the individual for 1 or more persons

444

maintaining the plan (including as an employee defined in section 401(c)(1) of title 26). (3) Qualified beneficiary (A) In general The term "qualified beneficiary" means, with respect to a covered employee under a group health plan, any other individual who, on the day before the qualifying event for that employee, is a beneficiary under the plan − (i) as the spouse of the covered employee, or (ii) as the dependent child of the employee. Such term shall also include a child who is born to or placed for adoption with the covered employee during the period of continuation coverage under this subchapter. (B) Special rule for terminations and reduced employment In the case of a qualifying event described in section 300bb−3(2) of this title, the term "qualified beneficiary" includes the covered employee. (4) Plan administrator The term "plan administrator" has the meaning given the term "administrator" by section 1002(16)(A) of title 29. −SOURCE− (July 1, 1944, ch. 373, title XXII, Sec. 2208, as added Pub. L. 99−272, title X, Sec. 10003(a), Apr. 7, 1986, 100 Stat. 236; amended Pub. L. 100−647, title III, Sec. 3011(b)(7), Nov. 10, 1988, 102 Stat. 3625; Pub. L. 101−239, title VI, Sec. 6801(c)(1), Dec. 19, 1989, 103 Stat. 2297; Pub. L. 104−191, title I, Sec. 102(d),

445

title III, Sec. 321(d)(3), title IV, Sec. 421(a)(3), Aug. 21, 1996, 110 Stat. 1978, 2059, 2088.) −MISC1− AMENDMENTS 1996 − Par. (1). Pub. L. 104−191, Sec. 321(d)(3), inserted at end "Such term shall not include any plan substantially all of the coverage under which is for qualified long−term care services (as defined in section 7702B(c) of title 26)." Pub. L. 104−191, Sec. 102(d), substituted "5000(b)" for "section 162(i)(2)". Par. (3)(A). Pub. L. 104−191, Sec. 421(a)(3), inserted at end "Such term shall also include a child who is born to or placed for adoption with the covered employee during the period of continuation coverage under this subchapter." 1989 − Par. (2). Pub. L. 101−239 substituted "the performance of services by the individual for 1 or more persons maintaining the plan (including as an employee defined in section 401(c)(1) of title 26)" for "the individual's employment or previous employment with an employer". 1988 − Par. (1). Pub. L. 100−647 substituted "section 162(i)(2) of the Internal Revenue Code of 1986" for "section 162(i)(3) of the Internal Revenue Code of 1954", which for purposes of codification was translated as "section 162(i)(2) of title 26". EFFECTIVE DATE OF 1996 AMENDMENT Amendment by section 321(d)(3) of Pub. L. 104−191 applicable to contracts issued after Dec. 31, 1996, see section 321(f) of Pub. L.

446

104−191, set out as an Effective Date note under section 7702B of Title 26, Internal Revenue Code. Amendment by section 421(a)(3) of Pub. L. 104−191 effective Jan. 1, 1997, regardless of whether the qualifying event occurred before, on, or after such date, see section 421(d) of Pub. L. 104−191, set out as a note under section 4980B of Title 26. EFFECTIVE DATE OF 1989 AMENDMENT Section 6801(c)(2) of Pub. L. 101−239 provided that: "The amendment made by paragraph (1) [amending this section] shall apply to plan years beginning after December 31, 1989." EFFECTIVE DATE OF 1988 AMENDMENT Amendment by Pub. L. 100−647 applicable to taxable years beginning after Dec. 31, 1988, but not applicable to any plan for any plan year to which section 162(k) of Title 26, Internal Revenue Code (as in effect on the day before Nov. 10, 1988), did not apply by reason of section 10001(e)(2) of Pub. L. 99−272, see section 3011(d) of Pub. L. 100−647, set out as a note under section 162 of Title 26. −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in section 300bb−5 of this title. −FOOTNOTE− (!1) So in original. Probably should be preceded by "section". −End− −CITE− 42 USC SUBCHAPTER XXI − RESEARCH WITH RESPECT TO ACQUIRED

447

IMMUNE DEFICIENCY SYNDROME 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXI − RESEARCH WITH RESPECT TO ACQUIRED IMMUNE DEFICIENCY SYNDROME −HEAD− SUBCHAPTER XXI − RESEARCH WITH RESPECT TO ACQUIRED IMMUNE DEFICIENCY SYNDROME −MISC1− PRIOR PROVISIONS A prior subchapter XXI (Sec. 300cc et seq.), comprised of title XXIII of the Public Health Service Act, act July 1, 1944, ch. 373, 2301−2316, was renumbered title XXV, Secs. 2501−2514, of the Public Health Service Act, and transferred to subchapter XXV (Sec. 300aaa et seq.) of this chapter, renumbered title XXVI, Secs. 2601−2614, of the Public Health Service Act, renumbered title XXVII, Secs. 2701−2714, of the Public Health Service Act, and renumbered title II, part B, Secs. 231−244, of the Public Health Service Act, and transferred to part B (Sec. 238 et seq.) of subchapter I of this chapter. −End− −CITE− 42 USC Part A − Administration of Research Programs 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE

448

CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXI − RESEARCH WITH RESPECT TO ACQUIRED IMMUNE DEFICIENCY SYNDROME Part A − Administration of Research Programs −HEAD− PART A − ADMINISTRATION OF RESEARCH PROGRAMS −End− −CITE− 42 USC Sec. 300cc 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXI − RESEARCH WITH RESPECT TO ACQUIRED IMMUNE DEFICIENCY SYNDROME Part A − Administration of Research Programs −HEAD− Sec. 300cc. Requirement of annual comprehensive report on all expenditures by Secretary with respect to acquired immune deficiency syndrome −STATUTE− (a) In general Not later than December 1 of each fiscal year, the Secretary shall prepare and submit to the Congress a report on the expenditures by the Secretary of amounts appropriated for the preceding fiscal year with respect to acquired immune deficiency syndrome.

449

(b) Inclusion of certain information The report required in subsection (a) of this section shall, with respect to acquired immune deficiency syndrome, include − (1) for each program, project, or activity with respect to such syndrome, a specification of the amount obligated by each office and agency of the Department of Health and Human Services; (2) a summary description of each such program, project, or activity; (3) a list of such programs, projects, or activities that are directed towards members of minority groups; (4) a description of the extent to which programs, projects, and activities described in paragraph (3) have been coordinated between the Director of the Office of Minority Health and the Director of the Centers for Disease Control and Prevention; (5) a summary of the progress made by each such program, project, or activity with respect to the prevention and control of acquired immune deficiency syndrome; (6) a summary of the evaluations conducted under this subchapter; and (7) any report required in this chapter to be submitted to the Secretary for inclusion in the report required in subsection (a) of this section. −SOURCE− (July 1, 1944, ch. 373, title XXIII, Sec. 2301, as added Pub. L. 100−607, title II, Sec. 201(4), Nov. 4, 1988, 102 Stat. 3063; amended Pub. L. 102−531, title III, Sec. 312(d)(16), Oct. 27, 1992,

450

106 Stat. 3505.) −MISC1− PRIOR PROVISIONS A prior section 300cc, act July 1, 1944, Sec. 2301, was successively renumbered by subsequent acts and transferred, see section 238 of this title. AMENDMENTS 1992 − Subsec. (b)(4). Pub. L. 102−531 substituted "Centers for Disease Control and Prevention" for "Centers for Disease Control". TERMINATION OF REPORTING REQUIREMENTS For termination, effective May 15, 2000, of provisions of law requiring submittal to Congress of any annual, semiannual, or other regular periodic report listed in House Document No. 103−7 (in which a report required under this section is listed on page 94), see section 3003 of Pub. L. 104−66, as amended, and section 1(a)(4) [div. A, Sec. 1402(1)] of Pub. L. 106−554, set out as notes under section 1113 of Title 31, Money and Finance. DEVELOPMENT OF RAPID HIV TEST Pub. L. 106−345, title V, Sec. 502, Oct. 20, 2000, 114 Stat. 1353, provided that: "(a) Expansion, Intensification, and Coordination of Research and Other Activities. − "(1) In general. − The Director of NIH shall expand, intensify, and coordinate research and other activities of the National Institutes of Health with respect to the development of reliable and affordable tests for HIV disease that can rapidly be

451

administered and whose results can rapidly be obtained (in this section referred to as 'rapid HIV test'). "(2) Report to congress. − The Director of NIH shall periodically submit to the appropriate committees of Congress a report describing the research and other activities conducted or supported under paragraph (1). "(3) Authorization of appropriations. − For the purpose of carrying out this subsection, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2001 through 2005. "(b) Premarket Review of Rapid HIV Tests. − "(1) In general. − Not later than 90 days after the date of the enactment of this Act [Oct. 20, 2000], the Secretary, in consultation with the Director of the Centers for Disease Control and Prevention and the Commissioner of Food and Drugs, shall submit to the appropriate committees of the Congress a report describing the progress made towards, and barriers to, the premarket review and commercial distribution of rapid HIV tests. The report shall − "(A) assess the public health need for and public health benefits of rapid HIV tests, including the minimization of false positive results through the availability of multiple rapid HIV tests; "(B) make recommendations regarding the need for the expedited review of rapid HIV test applications submitted to the Center for Biologics Evaluation and Research and, if such

452

recommendations are favorable, specify criteria and procedures for such expedited review; and "(C) specify whether the barriers to the premarket review of rapid HIV tests include the unnecessary application of requirements − "(i) necessary to ensure the efficacy of devices for donor screening to rapid HIV tests intended for use in other screening situations; or "(ii) for identifying antibodies to HIV subtypes of rare incidence in the United States to rapid HIV tests intended for use in screening situations other than donor screening. "(c) Guidelines of Centers for Disease Control and Prevention. − Promptly after commercial distribution of a rapid HIV test begins, the Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall establish or update guidelines that include recommendations for States, hospitals, and other appropriate entities regarding the ready availability of such tests for administration to pregnant women who are in labor or in the late stage of pregnancy and whose HIV status is not known to the attending obstetrician." LIMITATION ON EXPENDITURES FOR AIDS AND HIV ACTIVITIES Pub. L. 104−146, Sec. 11, May 20, 1996, 110 Stat. 1373, provided that: "Notwithstanding any other provision of law, the total amounts of Federal funds expended in any fiscal year for AIDS and HIV activities may not exceed the total amounts expended in such fiscal year for activities related to cancer."

453

VACCINES FOR HUMAN IMMUNODEFICIENCY VIRUS Pub. L. 103−43, title XIX, Sec. 1901(b), June 10, 1993, 107 Stat. 200, provided that: "(1) In general. − The Secretary of Health and Human Services, acting through the National Institutes of Health, shall develop a plan for the appropriate inclusion of HIV−infected women, including pregnant women, HIV−infected infants, and HIV−infected children in studies conducted by or through the National Institutes of Health concerning the safety and efficacy of HIV vaccines for the treatment and prevention of HIV infection. Such plan shall ensure the full participation of other Federal agencies currently conducting HIV vaccine studies and require that such studies conform fully to the requirements of part 46 of title 45, Code of Federal Regulations. "(2) Report. − Not later than 180 days after the date of the enactment of this Act [June 10, 1993], the Secretary of Health and Human Services shall prepare and submit to the Committee on Energy and Commerce of the House of Representatives, and the Committee on Labor and Human Resources of the Senate, a report concerning the plan developed under paragraph (1). "(3) Implementation. − Not later than 12 months after the date of the enactment of this Act, the Secretary of Health and Human Services shall implement the plan developed under paragraph (1), including measures for the full participation of other Federal agencies currently conducting HIV vaccine studies. "(4) Authorization of appropriations. − For the purpose of

454

carrying out this subsection, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 1994 through 1996." REQUIREMENT OF CERTAIN RESEARCH STUDIES Section 203 of Pub. L. 100−607 provided that after consultation with Director of National Center for Health Services Research and Health Care Technology Assessment, the Secretary of Health and Human Services, acting through the Director of Centers for Disease Control, was to conduct a study for purpose of determining mortality rates with respect to acquired immune deficiency syndrome among individuals of various groups at risk of such syndrome, among various geographic areas, and among individuals with varying financial resources for payment of health care services, with a report to be submitted to Congress not later than 18 months after Nov. 4, 1988, and further directed Secretary to request the National Academy of Sciences and other similar appropriate nonprofit institutions to report to the Secretary findings made by such institutions with respect to the manner in which research on, and the development of, vaccines and drugs for the prevention and treatment of acquired immune deficiency syndrome and related conditions can be enhanced by the establishment of consortia designed to combine and share resources needed for such research and development, consisting of businesses involved in such research and development, of nonprofit research institutions, or of combinations of such businesses and such institutions, and the appropriate participation, if any, of the Federal Government in

455

such consortia, with a report to be submitted to Congress not later than 1 year after Nov. 4, 1988. NATIONAL COMMISSION ON ACQUIRED IMMUNE DEFICIENCY SYNDROME Subtitle D (Secs. 241−249) of title II of Pub. L. 100−607, as amended by Pub. L. 100−690, title II, Sec. 2602(a), Nov. 18, 1988, 102 Stat. 4233, established National Commission on Acquired Immune Deficiency Syndrome for the purpose of promoting the development of a national consensus on policy concerning acquired immune deficiency syndrome and of studying and making recommendations for a consistent national policy concerning such syndrome, including financing of health care needs and research, dissemination of information to prevent spread of such syndrome, behavioral changes needed to combat such syndrome, and related civil rights issues, provided for membership of Commission, reports, executive director and staff of Commission, powers, and appropriations, and provided for termination of Commission 30 days after submission of its final report. −EXEC− EX. ORD. NO. 12963. PRESIDENTIAL ADVISORY COUNCIL ON HIV/AIDS Ex. Ord. No. 12963, June 14, 1995, 60 F.R. 31905, as amended by Ex. Ord. No. 13009, June 14, 1996, 61 F.R. 39799 [30799], provided: By the authority vested in me as President by the Constitution and the laws of the United States of America, I hereby direct the Secretary of Health and Human Services to exercise her discretion as follows: Section 1. Establishment. (a) The Secretary of Health and Human

456

Services (the "Secretary") shall establish an HIV/AIDS Advisory Council (the "Advisory Council" or the "Council"), to be known as the Presidential Advisory Council on HIV/AIDS. The Advisory Council shall be composed of not more than 35 members to be appointed or designated by the Secretary. The Advisory Council shall comply with the Federal Advisory Committee Act, as amended (5 U.S.C. App.). (b) The Secretary shall designate a Chairperson from among the members of the Advisory Council. Sec. 2. Functions. The Advisory Council shall provide advice, information, and recommendations to the Secretary regarding programs and policies intended to (a) promote effective prevention of HIV disease, (b) advance research on HIV and AIDS, and (c) promote quality services to persons living with HIV disease and AIDS. The functions of the Advisory Council shall be solely advisory in nature. The Secretary shall provide the President with copies of all written reports provided to the Secretary by the Advisory Council. Sec. 3. Administration. (a) The heads of executive departments and agencies shall, to the extent permitted by law, provide the Advisory Council with such information as it may require for purposes of carrying out its functions. (b) Any members of the Advisory Council that receive compensation shall be compensated in accordance with Federal law. Committee members may be allowed travel expenses, including per diem in lieu of subsistence, to the extent permitted by law for persons serving intermittently in the Government service (5 U.S.C. section

457

5701−5707). (c) To the extent permitted by law, and subject to the availability of appropriations, the Department of Health and Human Services shall provide the Advisory Council with such funds and support as may be necessary for the performance of its functions. Sec. 4. General Provisions. (a) Notwithstanding the provisions of any other Executive order, any functions of the President under the Federal Advisory Committee Act that are applicable to the Advisory Council, except that of reporting annually to the Congress, shall be performed by the Department of Health and Human Services, in accordance with the guidelines and procedures established by the Administrator of General Services. (b) This order is intended only to improve the internal management of the executive branch, and it is not intended to create any right, benefit, or trust responsibility, substantive or procedural, enforceable at law or equity by a party against the United States, its agencies, it officers, or any person. William J. Clinton. −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in sections 300cc−1, 300cc−41, 300ee−22 of this title. −End− −CITE− 42 USC Sec. 300cc−1 01/06/03 −EXPCITE−

458

TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXI − RESEARCH WITH RESPECT TO ACQUIRED IMMUNE DEFICIENCY SYNDROME Part A − Administration of Research Programs −HEAD− Sec. 300cc−1. Requirement of expediting awards of grants and contracts for research −STATUTE− (a) In general The Secretary shall expedite the award of grants, contracts, and cooperative agreements for research projects relating to acquired immune deficiency syndrome (including such research projects initiated independently of any solicitation by the Secretary for proposals for such research projects). (b) Time limitations with respect to certain applications (1) With respect to programs of grants, contracts, and cooperative agreements described in subsection (a) of this section, any application submitted in response to a solicitation by the Secretary for proposals pursuant to such a program − (A) may not be approved if the application is submitted after the expiration of the 3−month period beginning on the date on which the solicitation is issued; and (B) shall be awarded, or otherwise finally acted upon, not later than the expiration of the 6−month period beginning on the expiration of the period described in subparagraph (A).

459

(2) If the Secretary makes a determination that it is not practicable to administer a program referred to in paragraph (1) in accordance with the time limitations described in such paragraph, the Secretary may adjust the time limitations accordingly. (c) Requirements with respect to adjustments in time limitations With respect to any program for which a determination described in subsection (b)(2) of this section is made, the Secretary shall − (1) if the determination is made before the Secretary issues a solicitation for proposals pursuant to the program, ensure that the solicitation describes the time limitations as adjusted by the determination; and (2) if the determination is made after the Secretary issues such a solicitation for proposals, issue a statement describing the time limitations as adjusted by the determination and individually notify, with respect to the determination, each applicant whose application is submitted before the expiration of the 3−month period beginning on the date on which the solicitation was issued. (d) Annual reports to Congress Except as provided in subsection (e) of this section, the Secretary shall annually prepare, for inclusion in the comprehensive report required in section 300cc of this title, a report − (A) summarizing programs for which the Secretary has made a determination described in subsection (b)(2) of this section, including a description of the time limitations as adjusted by

460

the determination and including a summary of the solicitation issued by the Secretary for proposals pursuant to the program; and (B) summarizing applications that − (i) were submitted pursuant to a program of grants, contracts, or cooperative agreements referred to in paragraph (1) of subsection (b) of this section for which a determination described in paragraph (2) of such subsection has not been made; and (ii) were not processed in accordance with the time limitations described in such paragraph (1). (e) Quarterly reports for fiscal year 1989 For fiscal year 1989, the report required in subsection (d) of this section shall, not less than quarterly, be prepared and submitted to the Committee on Energy and Commerce of the House of Representatives and the Committee on Labor and Human Resources of the Senate. −SOURCE− (July 1, 1944, ch. 373, title XXIII, Sec. 2302, as added Pub. L. 100−607, title II, Sec. 201(4), Nov. 4, 1988, 102 Stat. 3063.) −MISC1− PRIOR PROVISIONS A prior section 300cc−1, act July 1, 1944, Sec. 2302, was successively renumbered by subsequent acts and transferred, see section 238a of this title. −CHANGE−

461

CHANGE OF NAME Committee on Energy and Commerce of House of Representatives treated as referring to Committee on Commerce of House of Representatives by section 1(a) of Pub. L. 104−14, set out as a note preceding section 21 of Title 2, The Congress. Committee on Commerce of House of Representatives changed to Committee on Energy and Commerce of House of Representatives, and jurisdiction over matters relating to securities and exchanges and insurance generally transferred to Committee on Financial Services of House of Representatives by House Resolution No. 5, One Hundred Seventh Congress, Jan. 3, 2001. −End− −CITE− 42 USC Sec. 300cc−2 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXI − RESEARCH WITH RESPECT TO ACQUIRED IMMUNE DEFICIENCY SYNDROME Part A − Administration of Research Programs −HEAD− Sec. 300cc−2. Requirements with respect to processing of requests for personnel and administrative support −STATUTE− (a) In general The Director of the Office of Personnel Management or the

462

Administrator of General Services, as the case may be, shall respond to any priority request made by the Administrator of the Substance Abuse and Mental Health Services Administration, the Director of the Centers for Disease Control and Prevention, the Commissioner of Food and Drugs, or the Director of the National Institutes of Health, not later than 21 days after the date on which such request is made. If the Director of the Office of Personnel Management or the Administrator of General Services, as the case may be, does not disapprove a priority request during the 21−day period, the request shall be deemed to be approved. (b) Notice to Secretary and to Assistant Secretary for Health The Administrator of the Substance Abuse and Mental Health Services Administration, the Director of the Centers for Disease Control and Prevention, the Commissioner of Food and Drugs, and the Director of the National Institutes of Health, shall, respectively, transmit to the Secretary and the Assistant Secretary for Health a copy of each priority request made under this section by the agency head involved. The copy shall be transmitted on the date on which the priority request involved is made. (c) "Priority request" defined For purposes of this section, the term "priority request" means any request that − (1) is designated as a priority request by the Administrator of the Substance Abuse and Mental Health Services Administration, the Director of the Centers for Disease Control and Prevention, the Commissioner of Food and Drugs, or the Director of the

463

National Institutes of Health; and (2)(A) is made to the Director of the Office of Personnel Management for the allocation of personnel to carry out activities with respect to acquired immune deficiency syndrome; or (B) is made to the Administrator of General Services for administrative support or space in carrying out such activities. −SOURCE− (July 1, 1944, ch. 373, title XXIII, Sec. 2303, as added Pub. L. 100−607, title II, Sec. 201(4), Nov. 4, 1988, 102 Stat. 3064; amended Pub. L. 102−321, title I, Secs. 161, 163(b)(7), July 10, 1992, 106 Stat. 375, 376; Pub. L. 102−531, title III, Sec. 312(d)(17), Oct. 27, 1992, 106 Stat. 3505.) −MISC1− PRIOR PROVISIONS A prior section 300cc−2, act July 1, 1944, Sec. 2303, was successively renumbered by subsequent acts and transferred, see section 238b of this title. AMENDMENTS 1992 − Subsec. (a). Pub. L. 102−531 substituted "Centers for Disease Control and Prevention" for "Centers for Disease Control". Pub. L. 102−321, Sec. 161, substituted "Administrator of the Substance Abuse and Mental Health Services Administration" for "Administrator of the Alcohol, Drug Abuse, and Mental Health Administration". Subsec. (b). Pub. L. 102−531 substituted "Centers for Disease

464

Control and Prevention" for "Centers for Disease Control". Pub. L. 102−321, Sec. 163(b)(7)(A), substituted "Administrator of the Substance Abuse and Mental Health Services Administration" for "Administrator of the Alcohol, Drug Abuse, and Mental Health Administration". Subsec. (c)(1). Pub. L. 102−531 substituted "Centers for Disease Control and Prevention" for "Centers for Disease Control". Pub. L. 102−321, Sec. 163(b)(7)(B), substituted "Administrator of the Substance Abuse and Mental Health Services Administration" for "Administrator of the Alcohol, Drug Abuse, and Mental Health Administration". EFFECTIVE DATE OF 1992 AMENDMENT Amendment by Pub. L. 102−321 effective Oct. 1, 1992, see section 801(c) of Pub. L. 102−321, set out as a note under section 236 of this title. −End− −CITE− 42 USC Sec. 300cc−3 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXI − RESEARCH WITH RESPECT TO ACQUIRED IMMUNE DEFICIENCY SYNDROME Part A − Administration of Research Programs −HEAD− Sec. 300cc−3. Establishment of Research Advisory Committee

465

−STATUTE− (a) In general After consultation with the Commissioner of Food and Drugs, the Secretary, acting through the Director of the National Institute of Allergy and Infectious Diseases, shall establish within such Institute an advisory committee to be known as the AIDS Research Advisory Committee (hereafter in this section referred to as the "Committee"). (b) Composition The Committee shall be composed of physicians whose clinical practice includes a significant number of patients with acquired immune deficiency syndrome. (c) Duties The Committee shall − (1) advise the Director of such Institute (and may provide advice to the Directors of other agencies of the National Institutes of Health, as appropriate) on appropriate research activities to be undertaken with respect to clinical treatment of such syndrome, including advice with respect to − (A) research on drugs for preventing or minimizing the development of symptoms or conditions arising from infection with the etiologic agent for such syndrome, including recommendations on the projects of research with respect to diagnosing immune deficiency and with respect to predicting, diagnosing, preventing, and treating opportunistic cancers and infectious diseases; and

466

(B) research on the effectiveness of treating such symptoms or conditions with drugs that − (i) are not approved by the Commissioner of Food and Drugs for the purpose of treating such symptoms or conditions; and (ii) are being utilized for such purpose by individuals infected with such etiologic agent; (2)(A) review ongoing publicly and privately supported research on clinical treatment for acquired immune deficiency syndrome, including research on drugs described in paragraph (1); and (B) periodically issue, and make available to health care professionals, reports describing and evaluating such research; (3) conduct studies and convene meetings for the purpose of determining the recommendations among physicians in clinical practice on clinical treatment of acquired immune deficiency syndrome, including treatment with the drugs described in paragraph (1); and (4) conduct a study for the purpose of developing, with respect to individuals infected with the etiologic agent for acquired immune deficiency syndrome, a consensus among health care professionals on clinical treatments for preventing or minimizing the development of symptoms or conditions arising from infection with such etiologic agent. −SOURCE− (July 1, 1944, ch. 373, title XXIII, Sec. 2304, as added Pub. L. 100−607, title II, Sec. 201(4), Nov. 4, 1988, 102 Stat. 3065; amended Pub. L. 100−690, title II, Sec. 2617(a), Nov. 18, 1988, 102

467

Stat. 4240; Pub. L. 103−43, title XVIII, Sec. 1811(1), title XX, Sec. 2008(d)(1), June 10, 1993, 107 Stat. 199, 212.) −MISC1− PRIOR PROVISIONS A prior section 300cc−3, acts July 1, 1944, ch. 373, title XXIII, Sec. 2304, formerly title V, Sec. 504, 58 Stat. 710; June 25, 1948, ch. 654, Sec. 6, 62 Stat. 1018; 1953 Reorg. Plan No. 1, Secs. 5, 8, eff. Apr. 11, 1953, 18 F.R. 2053, 67 Stat. 631; renumbered title XXI, Sec. 2104, Apr. 26, 1983, Pub. L. 98−24, Sec. 2(a)(1), 97 Stat. 176; renumbered title XXIII, Sec. 2304, Nov. 14, 1986, Pub. L. 99−660, title III, Sec. 311(a), 100 Stat. 3755, related to care of Service patients at Saint Elizabeths Hospital, prior to repeal by Pub. L. 98−621, Sec. 10(s), Nov. 8, 1984, 98 Stat. 3381, effective Oct. 1, 1987. Subsequent to repeal, section 2104 of title XXI of act July 1, 1944, was renumbered section 2304 of title XXIII of that act by section 311(a) of Pub. L. 99−660. A prior section 300cc−4, acts July 1, 1944, ch. 373, title XXI, Sec. 2105, formerly title V, Sec. 505, 58 Stat. 710; 1953 Reorg. Plan No. 1, Secs. 5, 8, eff. Apr. 11, 1953, 18 F.R. 2053, 67 Stat. 631; renumbered title XXI, Sec. 2105, Apr. 26, 1983, Pub. L. 98−24, Sec. 2(a)(1), 97 Stat. 176, provided procedures under which the Secretary could settle claims for damages from collisions or incident to the operation of vessels within a year of the accrual of such claims and not to exceed $3,000, prior to repeal by Pub. L. 99−117, Sec. 12(f), Oct. 7, 1985, 99 Stat. 495. Subsequent to repeal, section 2105 of title XXI of act July 1, 1944, was

468

renumbered section 2305 of title XXIII of that act by Pub. L. 99−660, title III, Sec. 311(a), Nov. 14, 1986, 100 Stat. 3755. Prior sections 300cc−5 to 300cc−10, act July 1, 1944, Secs. 2306 to 2311, respectively, were successively renumbered by subsequent acts and transferred, see sections 238c to 238h of this title. AMENDMENTS 1993 − Pub. L. 103−43, Sec. 2008(d)(1)(A), substituted "Research Advisory Committee" for "Clinical Research Review Committee" in section catchline. Subsec. (a). Pub. L. 103−43, Sec. 2008(d)(1)(B), substituted "AIDS Research Advisory Committee" for "AIDS Clinical Research Review Committee". Subsec. (c)(1). Pub. L. 103−43, Sec. 1811(1), in introductory provisions inserted "(and may provide advice to the Directors of other agencies of the National Institutes of Health, as appropriate)" after "Director of such Institute" and in subpar. (A) inserted before semicolon at end ", including recommendations on the projects of research with respect to diagnosing immune deficiency and with respect to predicting, diagnosing, preventing, and treating opportunistic cancers and infectious diseases". 1988 − Subsec. (c)(2)(B). Pub. L. 100−690 substituted semicolon for period. EFFECTIVE DATE OF 1988 AMENDMENT Amendment by Pub. L. 100−690 effective immediately after enactment of Pub. L. 100−607, which was approved Nov. 4, 1988, see section 2600 of Pub. L. 100−690, set out as a note under section

469

242m of this title. TERMINATION OF ADVISORY COMMITTEES Advisory committees established after Jan. 5, 1973, to terminate not later than the expiration of the 2−year period beginning on the date of their establishment, unless, in the case of a committee established by the President or an officer of the Federal Government, such committee is renewed by appropriate action prior to the expiration of such 2−year period, or in the case of a committee established by the Congress, its duration is otherwise provided by law. See section 14 of Pub. L. 92−463, Oct. 6, 1972, 86 Stat. 776, set out in the Appendix to Title 5, Government Organization and Employees. Pub. L. 93−641, Sec. 6, Jan. 4, 1975, 88 Stat. 2275, set out as a note under section 217a of this title, provided that an advisory committee established pursuant to the Public Health Service Act shall terminate at such time as may be specifically prescribed by an Act of Congress enacted after Jan. 4, 1975. −SECREF− SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in sections 300cc−12, 300cc−14, 300cc−17, 300cc−18 of this title. −End− −CITE− 42 USC Part B − Research Authority 01/06/03 −EXPCITE− TITLE 42 − THE PUBLIC HEALTH AND WELFARE

470

CHAPTER 6A − PUBLIC HEALTH SERVICE SUBCHAPTER XXI − RESEARCH WITH RESPECT TO ACQUIRED IMMUNE DEFICIENCY SYNDROME Part B − Research Authority −HEAD− PART B − RESEARCH AUTHORITY −End− −CITE− 42 USC Sec. 300cc−11 01/06/03 −EXPCITE−

471