dreamproit/uscode huggingface dataset:
42 U.S.C. § 300bb–4 (THE PUBLIC HEALTH AND WELFARE)
§ 300bb–4. Applicable premium
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).
(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
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.
(July 1, 1944, ch. 373, title XXII, § 2204, as added Pub. L. 99–272, title X, § 10003(a), Apr. 7, 1986, 100 Stat. 234.)
42 U.S.C. § 300bb–7 (THE PUBLIC HEALTH AND WELFARE)
§ 300bb–7. Enforcement
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.
(July 1, 1944, ch. 373, title XXII, § 2207, as added Pub. L. 99–272, title X, § 10003(a), Apr. 7, 1986, 100 Stat. 236.)
heading: Continued Coverage of Costs of Pediatric Vaccine Under Certain Group Health Plans
text: Pub. L. 103–66, title XIII, § 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.
“(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].”
42 U.S.C. § 300cc (THE PUBLIC HEALTH AND WELFARE)
§ 300cc. Repealed. Pub. L. 109–482, title I, § 104(b)(2)(C), Jan. 15, 2007, 120 Stat. 3693
text: Section, act July 1, 1944, ch. 373, title XXIII, § 2301, as added Pub. L. 100–607, title II, § 201(4), Nov. 4, 1988, 102 Stat. 3063; amended Pub. L. 102–531, title III, § 312(d)(16), Oct. 27, 1992, 106 Stat. 3505, required an annual comprehensive report on all expenditures by Secretary with respect to AIDS.
text: A prior section 300cc, act July 1, 1944, § 2301, was successively renumbered by subsequent acts and transferred, see section 238 of this title.
heading: Effective Date of Repeal
text: Repeal applicable only with respect to amounts appropriated for fiscal year 2007 or subsequent fiscal years, see section 109 of Pub. L. 109–482, set out as an Effective Date of 2007 Amendment note under section 281 of this title.
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) of this section, 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) of this section, 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) of this section 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) of this section 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) of this section 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) of this section 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–19 (THE PUBLIC HEALTH AND WELFARE)
§ 300cc–19. National blood resource education program
After consultation with the Director of the National Heart, Lung, and Blood Institute and the Commissioner of Food and Drugs, the Secretary shall establish a program of research and education regarding blood donations and transfusions to maintain and improve the safety of the blood supply. Education programs shall be directed at health professionals, patients, and the community to—
(1) in the case of the public and patients undergoing treatment—
(A) increase awareness that the process of donating blood is safe;
(B) promote the concept that blood donors are contributors to a national need to maintain an adequate and safe blood supply;
(C) encourage blood donors to donate more than once a year; and
(D) encourage repeat blood donors to recruit new donors;
(2) in the case of health professionals—
(A) improve knowledge, attitudes, and skills of health professionals in the appropriate use of blood and blood components;
(B) increase the awareness and understanding of health professionals regarding the risks versus benefits of blood transfusion; and
(C) encourage health professionals to consider alternatives to the administration of blood or blood components for their patients; and
(3) in the case of the community, increase coordination, communication, and collaboration among community, professional, industry, and government organizations regarding blood donation and transfusion issues.
(July 1, 1944, ch. 373, title XXIII, § 2319, as added Pub. L. 100–607, title II, § 201(4), Nov. 4, 1988, 102 Stat. 3074.)
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) of this section 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.
42 U.S.C. § 300cc–40 (THE PUBLIC HEALTH AND WELFARE)
§ 300cc–40. Establishment of Office
(a) In general
There is established within the National Institutes of Health an office to be known as the Office of AIDS Research. The Office shall be headed by a director, who shall be appointed by the Secretary.
(b) Duties
(1) Interagency coordination of AIDS activities
With respect to acquired immune deficiency syndrome, the Director of the Office shall plan, coordinate, and evaluate research and other activities conducted or supported by the agencies of the National Institutes of Health. In carrying out the preceding sentence, the Director of the Office shall evaluate the AIDS activities of each of such agencies and shall provide for the periodic reevaluation of such activities.
(2) Consultations
The Director of the Office shall carry out this subpart (including developing and revising the plan required in section 300cc–40c of this title) in consultation with the heads of the agencies of the National Institutes of Health, with the advisory councils of the agencies, and with the advisory council established under section 300cc–40b of this title.
(3) Coordination
The Director of the Office shall act as the primary Federal official with responsibility for overseeing all AIDS research conducted or supported by the National Institutes of Health, and
(A) shall serve to represent the National Institutes of Health AIDS Research Program at all relevant Executive branch task forces and committees; and
(B) shall maintain communications with all relevant Public Health Service agencies and with various other departments of the Federal Government, to ensure the timely transmission of information concerning advances in AIDS research and the clinical treatment of acquired immune deficiency syndrome and its related conditions, between these various agencies for dissemination to affected communities and health care providers.
(July 1, 1944, ch. 373, title XXIII, § 2351, as added Pub. L. 103–43, title XVIII, § 1801(a)(3), June 10, 1993, 107 Stat. 192.)
42 U.S.C. § 300cc–40a (THE PUBLIC HEALTH AND WELFARE)
§ 300cc–40a. Microbicide research
(a) Federal strategic plan
The Director of the Office shall—
(1) expedite the implementation of the Federal strategic plans required by section 283(a) of this title regarding the conduct and support of research on, and development of, a microbicide to prevent the transmission of the human immunodeficiency virus; and
(2) review and, as appropriate, revise such plan to prioritize funding and activities relative to their scientific urgency and potential market readiness.
(b) Coordination
In implementing, reviewing, and prioritizing elements of the plan described in subsection (a), the Director of the Office shall consult, as appropriate, with—
(1) representatives of other Federal agencies involved in microbicide research, including the Coordinator of United States Government Activities to Combat HIV/AIDS Globally, the Director of the Centers for Disease Control and Prevention, and the Administrator of the United States Agency for International Development;
(2) the microbicide research and development community; and
(3) health advocates.
(July 1, 1944, ch. 373, title XXIII, § 2351A, as added Pub. L. 110–293, title II, § 203(b), July 30, 2008, 122 Stat. 2940.)
heading: Prior Provisions
text: A prior section 300cc–40a, act July 1, 1944, ch. 373, title XXIII, § 2352, as added Pub. L. 103–43, title XVIII, § 1801(a)(3), June 10, 1993, 107 Stat. 193, which required the establishment of an advisory council and coordinating committees, was transferred to section 300cc–40b of this title.
heading: Sense of Congress
text: Pub. L. 110–293, title II, § 203(a), July 30, 2008, 122 Stat. 2940, provided that: “Congress recognizes the need and urgency to expand the range of interventions for preventing the transmission of human immunodeficiency virus (HIV), including nonvaccine prevention methods that can be controlled by women.”
42 U.S.C. § 300cc–45 (THE PUBLIC HEALTH AND WELFARE)
§ 300cc–45. General provisions regarding Office
(a) Administrative support for Office
The Secretary, acting through the Director of the National Institutes of Health, shall provide administrative support and support services to the Director of the Office and shall ensure that such support takes maximum advantage of existing administrative structures at the agencies of the National Institutes of Health.
(b) Evaluation
Not later than 5 years after June 10, 1993, the Secretary shall conduct an evaluation to—
(1) determine the effect of this section on the planning and coordination of the AIDS research programs at the institutes, centers and divisions of the National Institutes of Health;
(2) evaluate the extent to which this part has eliminated the duplication of administrative resources among such Institutes, centers and divisions; and
(3) provide recommendations concerning future alterations with respect to this part.
(c) Definitions
For purposes of this part:
(1) The term “AIDS activities” means AIDS research and other activities that relate to acquired immune deficiency syndrome.
(2) The term “AIDS research” means research with respect to acquired immune deficiency syndrome.
(3) The term “Office” means the Office of AIDS Research.
(4) The term “Plan” means the plan required in section 300cc–40c(a)(1) of this title.
(July 1, 1944, ch. 373, title XXIII, § 2359, as added Pub. L. 103–43, title XVIII, § 1803, June 10, 1993, 107 Stat. 198; amended Pub. L. 109–482, title I, § 104(b)(2)(F), Jan. 15, 2007, 120 Stat. 3693.)
heading: Amendments
text: 2007—Subsec. (b). Pub. L. 109–482 substituted “Evaluation” for “Evaluation and report” in heading, struck out par. (1) designation before “Not later than”, redesignated subpars. (A) to (C) as pars. (1) to (3), respectively, and struck out heading and text of former par. (2). Text read as follows: “Not later than 1 year after the date on which the evaluation is commenced under paragraph (1), the Secretary shall prepare and submit to the Committee on Labor and Human Resources of the Senate, and the Committee on Energy and Commerce of the House of Representatives, a report concerning the results of such evaluation.”
heading: Effective Date of 2007 Amendment
text: Amendment by Pub. L. 109–482 applicable only with respect to amounts appropriated for fiscal year 2007 or subsequent fiscal years, see section 109 of Pub. L. 109–482, set out as a note under section 281 of this title.