dreamproit/uscode huggingface dataset:
42 U.S.C. § 300aa–17 (THE PUBLIC HEALTH AND WELFARE)
§ 300aa–17. Subrogation
(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) shall be collected on behalf of, and deposited in, the Vaccine Injury Compensation Trust Fund established under section 9510 of title 26.
(July 1, 1944, ch. 373, title XXI, § 2117, as added Pub. L. 99–660, title III, § 311(a), Nov. 14, 1986, 100 Stat. 3770; amended Pub. L. 100–203, title IV, § 4307(7), Dec. 22, 1987, 101 Stat. 1330–225; Pub. L. 101–239, title VI, § 6601(m)(2), Dec. 19, 1989, 103 Stat. 2291.)
heading: Amendments
text: 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).”
heading: Effective Date of 1989 Amendment
text: 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.
42 U.S.C. § 300aa–28 (THE PUBLIC HEALTH AND WELFARE)
§ 300aa–28. Manufacturer recordkeeping and reporting
(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 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) 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 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.
(July 1, 1944, ch. 373, title XXI, § 2128, as added Pub. L. 99–660, title III, § 311(a), Nov. 14, 1986, 100 Stat. 3777; amended Pub. L. 100–203, title IV, § 4302(b)(1), Dec. 22, 1987, 101 Stat. 1330–221.)
heading: Codification
text: 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.
heading: Amendments
text: 1987—Subsec. (a). Pub. L. 100–203 substituted “effective date of this subpart” for “effective date of this part”.
42 U.S.C. § 300aa–31 (THE PUBLIC HEALTH AND WELFARE)
§ 300aa–31. Citizen’s actions
(a) General rule
Except as provided in subsection (b), 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) 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.
(July 1, 1944, ch. 373, title XXI, § 2131, as added Pub. L. 99–660, title III, § 311(a), Nov. 14, 1986, 100 Stat. 3778; amended Pub. L. 100–203, title IV, § 4305, Dec. 22, 1987, 101 Stat. 1330–224.)
heading: Amendments
text: 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.
heading: Effective Date
text: 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.
42 U.S.C. § 300aa–34 (THE PUBLIC HEALTH AND WELFARE)
§ 300aa–34. Termination of program
(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) the Secretary determines that at the end of the period 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:
Period reviewed:
Total number of awards by the end of the period 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
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.
(July 1, 1944, ch. 373, title XXI, § 2134, as added Pub. L. 100–203, title IV, § 4303(f), Dec. 22, 1987, 101 Stat. 1330–222.)
heading: Codification
text: 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.
42 U.S.C. § 300bb–1 (THE PUBLIC HEALTH AND WELFARE)
§ 300bb–1. State and local governmental group health plans must provide continuation coverage to certain individuals
(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) 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.
(July 1, 1944, ch. 373, title XXII, § 2201, as added Pub. L. 99–272, title X, § 10003(a), Apr. 7, 1986, 100 Stat. 232; amended Pub. L. 101–239, title VI, § 6801(a)(1), Dec. 19, 1989, 103 Stat. 2296.)
heading: Amendments
text: 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).”
heading: Effective Date of 1989 Amendment
text: Pub. L. 101–239, title VI, § 6801(a)(2), Dec. 19, 1989, 103 Stat. 2297, provided that: “The amendment made by paragraph (1) [amending this section] shall apply to years beginning after December 31, 1986.”
heading: Effective Date
text: Pub. L. 99–272, title X, § 10003(b), Apr. 7, 1986, 100 Stat. 236, 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—
“(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.”
42 U.S.C. § 300cc–11 (THE PUBLIC HEALTH AND WELFARE)
§ 300cc–11. Clinical evaluation units at National Institutes of Health
(a) In general
The Secretary, acting through the Director of the National Cancer Institute and the Director of the National Institute of Allergy and Infectious Diseases, shall for each such Institute establish a clinical evaluation unit at the Clinical Center at the National Institutes of Health. Each of the clinical evaluation units—
(1) shall conduct clinical evaluations of experimental treatments for acquired immune deficiency syndrome developed within the preclinical drug development program, including evaluations of methods of diagnosing immune deficiency and evaluations of methods of predicting, diagnosing, preventing, and treating opportunistic cancers and infectious diseases; and
(2) may conduct clinical evaluations of experimental treatments for such syndrome that are developed by any other national research institute of the National Institutes of Health or by any other entity.
(b) Personnel and administrative support
(1) For the purposes described in subsection (a), the Secretary, acting through the Director of the National Institutes of Health, shall provide each of the clinical evaluation units required in such subsection—
(A)
(i) with not less than 50 beds; or
(ii) with an outpatient clinical capacity equal to not less than twice the outpatient clinical capacity, with respect to acquired immune deficiency syndrome, possessed by the Clinical Center of the National Institutes of Health on June 1, 1988; and
(B) with such personnel, such administrative support, and such other support services as may be necessary.
(2) Facilities, personnel, administrative support, and other support services provided pursuant to paragraph (1) shall be in addition to the number or level of facilities, personnel, administrative support, and other support services that otherwise would be available at the Clinical Center at the National Institutes of Health for the provision of clinical care for individuals with diseases or disorders.
(c) Authorization of appropriations
For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary.
(July 1, 1944, ch. 373, title XXIII, § 2311, as added Pub. L. 100–607, title II, § 201(4), Nov. 4, 1988, 102 Stat. 3066; amended Pub. L. 103–43, title XVIII, § 1811(2), June 10, 1993,107 Stat. 199.)
heading: Prior Provisions
text: A prior section 300cc–11, act July 1, 1944, § 2312, was successively renumbered by subsequent acts and transferred, see section 238i of this title.
heading: Amendments
text: 1993—Subsec. (a)(1). Pub. L. 103–43 inserted before semicolon at end “, including evaluations of methods of diagnosing immune deficiency and evaluations of methods of predicting, diagnosing, preventing, and treating opportunistic cancers and infectious dis­eases”.
42 U.S.C. § 300cc–14 (THE PUBLIC HEALTH AND WELFARE)
§ 300cc–14. Evaluation of certain treatments
(a) Establishment of program
(1) After consultation with the AIDS Research Advisory Committee established pursuant to section 300cc–3 of this title, the Secretary shall establish a program for the evaluation of drugs that—
(A) are not approved by the Commissioner of Food and Drugs for the purpose of treatments with respect to acquired immune deficiency syndrome; and
(B) are being utilized for such purpose by individuals infected with the etiologic agent for such syndrome.
(2) The program established under paragraph (1) shall include evaluations of the effectiveness and the risks of the treatment involved, including the risks of foregoing treatments with respect to acquired immune deficiency syndrome that are approved by the Commissioner of Food and Drugs.
(b) Authority with respect to grants and contracts
(1) For the purpose of conducting evaluations required in subsection (a), the Secretary may make grants to, and enter into cooperative agreements and contracts with, public and nonprofit private entities.
(2) Nonprofit private entities under paragraph (1) may include nonprofit private organizations that—
(A) are established for the purpose of evaluating treatments with respect to acquired immune deficiency syndrome; and
(B) consist primarily of individuals infected with the etiologic agent for such syndrome.
(c) Scientific and ethical guidelines
(1) The Secretary shall establish appropriate scientific and ethical guidelines for the conduct of evaluations carried out pursuant to this section. The Secretary may not provide financial assistance under subsection (b)(1) unless the applicant for such assistance agrees to comply with such guidelines.
(2) The Secretary may establish the guidelines described in paragraph (1) only after consulting with—
(A) physicians whose clinical practice includes a significant number of individuals with acquired immune deficiency syndrome;
(B) individuals who are infected with the etiologic agent for such syndrome; and
(C) other individuals with appropriate expertise or experience.
(d) Authorization of appropriations
For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary.
(July 1, 1944, ch. 373, title XXIII, § 2314, as added Pub. L. 100–607, title II, § 201(4), Nov. 4, 1988, 102 Stat. 3069; amended Pub. L. 103–43, title XX, § 2008(d)(3), June 10, 1993, 107 Stat. 212.)
heading: Prior Provisions
text: A prior section 300cc–14, act July 1, 1944, § 2315, was successively renumbered by subsequent acts and transferred, see section 238l of this title.
heading: Amendments
text: 1993—Subsec. (a)(1). Pub. L. 103–43 substituted “AIDS Research Advisory Committee” for “Clinical Research Review Committee” in introductory provisions.
42 U.S.C. § 300cc–16 (THE PUBLIC HEALTH AND WELFARE)
§ 300cc–16. Research centers
(a) In general
(1) The Secretary, acting through the Director of the National Institute of Allergy and Infectious Diseases, may make grants to, and enter into contracts with, public and nonprofit private entities to assist such entities in planning, establishing, or strengthening, and providing basic operating support for, centers for basic and clinical research into, and training in, advanced diagnostic, prevention, and treatment methods for acquired immune deficiency syndrome.
(2) A grant or contract under paragraph (1) shall be provided in accordance with policies established by the Secretary, acting through the Director of the National Institutes of Health, and after consultation with the advisory council for the National Institute of Allergy and Infectious Diseases.
(3) The Secretary shall ensure that, as appropriate, clinical research programs carried out under paragraph (1) include as research subjects women, children, hemophiliacs, and minorities.
(b) Use of financial assistance
(1) Financial assistance under subsection (a) may be expended for—
(A) the renovation or leasing of space;
(B) staffing and other basic operating costs, including such patient care costs as are required for clinical research;
(C) clinical training with respect to acquired immune deficiency syndrome (including such training for allied health professionals); and
(D) demonstration purposes, including projects in the long-term monitoring and outpatient treatment of individuals infected with the etiologic agent for such syndrome.
(2) Financial assistance under subsection (a) may not be expended to provide research training for which Ruth L. Kirschstein National Research Service Awards may be provided under section 288 of this title.
(c) Duration of support
Support of a center under subsection (a) may be for not more than five years. Such period may be extended by the Director for additional periods of not more than five years each if the operations of such center have been reviewed by an appropriate technical and scientific peer review group established by the Director and if such group has recommended to the Director that such period should be extended.
(d) Authorization of appropriations
For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary.
(July 1, 1944, ch. 373, title XXIII, § 2316, as added Pub. L. 100–607, title II, § 201(4), Nov. 4, 1988, 102 Stat. 3071; amended Pub. L. 107–206, title I, § 804(c), Aug. 2, 2002, 116 Stat. 874.)
heading: Amendments
text: 2002—Subsec. (b)(2). Pub. L. 107–206 substituted “Ruth L. Kirschstein National Research Service Awards” for “National Research Service Awards”.
42 U.S.C. § 300cc–31 (THE PUBLIC HEALTH AND WELFARE)
§ 300cc–31. Fellowships and training
(a) In general
The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall establish fellowship and training programs to be conducted by the Centers for Disease Control and Prevention to train individuals to develop skills in epidemiology, surveillance, testing, counseling, education, information, and laboratory analysis relating to acquired immune deficiency syndrome. Such programs shall be designed to enable health professionals and health personnel trained under such programs to work, after receiving such training, in national and international efforts toward the prevention, diagnosis, and treatment of acquired immune deficiency syndrome.
(b) Programs conducted by National Institute of Mental Health
The Secretary, acting through the Director of the National Institute of Mental Health, shall conduct or support fellowship and training programs for individuals pursuing graduate or postgraduate study in order to train such individuals to conduct scientific research into the psychological and social sciences as such sciences relate to acquired immune deficiency syndrome.
(c) Relationship to limitation on number of employees
Any individual receiving a fellowship or receiving training under subsection (a) or (b) shall not be included in any determination of the number of full-time equivalent employees of the Department of Health and Human Services for the purpose of any limitation on the number of such employees established by law prior to, on, or after November 4, 1988.
(d) 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 fiscal year.
(July 1, 1944, ch. 373, title XXIII, § 2341, as added Pub. L. 100–607, title II, § 201(4), Nov. 4, 1988, 102 Stat. 3076; amended Pub. L. 100–690, title II, § 2617(e), Nov. 18, 1988, 102 Stat. 4240; Pub. L. 102–531, title III, § 312(d)(21), Oct. 27, 1992, 106 Stat. 3505; Pub. L. 103–43, title XVIII, § 1811(7), June 10, 1993, 107 Stat. 200.)
heading: Amendments
text: 1993—Subsec. (d). Pub. L. 103–43 substituted “fiscal year” for “of the fiscal years 1989 through 1991”.
1992—Subsec. (a). Pub. L. 102–531, which directed the substitution of “Centers for Disease Control and Prevention” for “Centers for Disease Control”, was executed by making the substitution in two places to reflect the probable intent of Congress.
1988—Subsec. (c). Pub. L. 100–690 substituted “date of the enactment of the AIDS Amendments of 1988” for “date of the enactment of the AIDS Federal Policy Act of 1988” which for purposes of codification was translated as “November 4, 1988”.
heading: Effective Date of 1988 Amendment
text: 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 242m of this title.