§300cc–13 — Title 42 The Public Health and Welfare | U.S. Code

Summary

The Director of the National Institutes of Health, working through the head of NIAID and after talking with the Commissioner of Food and Drugs, may give grants and make contracts with public and nonprofit groups that work on AIDS. The money is for planning and running community clinical trials of experimental treatments for the infection that causes AIDS when the FDA has allowed the treatment for investigational use under 21 U.S.C. 355. The funding can help community groups and health centers pay for medical supervision, do paperwork and data work, and train local doctors, nurse practitioners, physician assistants, and other health workers. It can also pay for demonstration projects that bring trials to all affected groups, including minorities, hemophiliacs and transfusion-exposed people, women, children, intravenous drug users, and people who have the infection but no symptoms. Those demonstration projects must be approved by the FDA Commissioner, by an Institutional Review Board that meets part 56 of title 21, Code of Federal Regulations, and by the NIAID Director. The Secretary can only give money if an application is filed, contains assurances the Secretary accepts, and follows the Secretary’s rules. Funds “such sums as may be necessary” are authorized for each fiscal year 1989 through 1996.

Title 42, §300cc–13

The Public Health and Welfare — Source: USLM XML via OLRC

(a)After consultation with the Commissioner of Food and Drugs, the Director of the National Institutes of Health, acting through the Director of the National Institute of Allergy and Infectious Diseases, may make grants to public entities and nonprofit private entities concerned with acquired immune deficiency syndrome, and may enter into contracts with public and private such 11 So in original. entities, for the purpose of planning and conducting, in the community involved, clinical trials of experimental treatments for infection with the etiologic agent for such syndrome that are approved by the Commissioner of Food and Drugs for investigational use under regulations issued under section 355 of title 21.

(b)(1)Financial assistance under subsection (a) shall include such assistance to community-based organizations and community health centers for the purpose of—

(A)retaining appropriate medical supervision;

(B)assisting with administration, data collection and record management; and

(C)conducting training of community physicians, nurse practitioners, physicians’ assistants and other health professionals for the purpose of conducting clinical trials.

(2)(A)Financial assistance under subsection (a) shall include such assistance for demonstration projects designed to implement and conduct community-based clinical trials in order to provide access to the entire scope of communities affected by infections with the etiologic agent for acquired immune deficiency syndrome, including minorities, hemophiliacs and transfusion-exposed individuals, women, children, users of intravenous drugs, and individuals who are asymptomatic with respect to such infection.

(B)The Director of the National Institutes of Health may not provide financial assistance under this paragraph unless the application for such assistance is approved—

(i)by the Commissioner of Food and Drugs;

(ii)by a duly constituted Institutional Review Board that meets the requirements of part 56 of title 21, Code of Federal Regulations; and

(iii)by the Director of the National Institute of Allergy and Infectious Diseases.

(c)Programs carried out with financial assistance provided under subsection (a) shall be designed to encourage private industry and schools of medicine, osteopathic medicine, and existing consortia of primary care providers organized to conduct clinical research concerning acquired immune deficiency syndrome to participate in, and to support, the clinical trials conducted pursuant to the programs.

(d)The Secretary may not provide financial assistance under subsection (a) unless—

(1)an application for the assistance is submitted to the Secretary;

(2)with respect to carrying out the purpose for which the assistance is to be made, the application provides assurances of compliance satisfactory to the Secretary; and

(3)the application otherwise is 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 section.

(e)(1)For the purpose of carrying out subsection (b)(1), there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 1989 through 1996.

(2)For the purpose of carrying out subsection (b)(2), there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 1989 through 1996.

Notes & Related Subsidiaries

Editorial Notes

Prior Provisions

A prior section 300cc–13, act July 1, 1944, § 2314, was successively renumbered by subsequent acts and transferred, see section 238k of this title.

Amendments

1991—Pub. L. 102–96, § 3(1), substituted “Terry Beirn Community-Based AIDS Research Initiative” for “Community-based evaluations of experimental therapies” in section catchline. Subsec. (c). Pub. L. 102–96, § 3(2), substituted “, schools of medicine and primary providers” for “and schools of medicine” in heading and substituted “schools of medicine, osteopathic medicine, and existing consortia of primary care providers organized to conduct clinical research concerning acquired immune deficiency syndrome” for “schools of medicine and osteopathic medicine”. Subsec. (e). Pub. L. 102–96, § 3(3), substituted “1996” for “1991” in pars. (1) and (2). 1989—Subsec. (c). Pub. L. 101–93 inserted “and osteopathic medicine” after “schools of medicine”. 1988—Subsec. (a). Pub. L. 100–690, § 2617(b)(1), which directed substitution of “through the Director of the National Institute of Allergy” for “through the National Institutes of Allergy”, was executed by making substitution for “through the National Institute of Allergy” as the probable intent of Congress. Subsec. (b)(2)(B)(iii). Pub. L. 100–690, § 2617(b)(2), which directed substitution of “Institute” for “Institutes”, could not be executed because “Institute” was singular in original.

Statutory Notes and Related Subsidiaries

Effective Date

of 1988 AmendmentAmendment 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. Reference to Community, Migrant, Public Housing, or Homeless Health Center Considered Reference to Health CenterReference to community health center, migrant health center, public housing health center, or homeless health center considered reference to health center, see section 4(c) of Pub. L. 104–299, set out as a note under section 254b of this title. Findings and Sense of Congress Pub. L. 102–96, § 2, Aug. 14, 1991, 105 Stat. 481, provided that: “(a) Findings.—Congress finds that—“(1) community-based clinical trials complement the National Institute of Allergy and Infectious Diseases’ university-based research in order to provide increased access to experimental therapies; “(2) community-based clinical trials provide an efficient and cost-effective means to develop new HIV-related treatments, benefiting all people living with HIV disease and other illnesses; and “(3) because the community-based clinical trials model has a proven ability to conduct rapid trials that meet the very highest standards of scientific inquiry, this program should be reauthorized and significantly expanded. “(b) Sense of Congress.—It is the sense of Congress that, because of Terry Beirn’s tireless efforts to foster a partnership among all parties invested in AIDS research (including the National Institutes of Health university-based research system, primary care physicians practicing in the community, and patients), the community-based clinical trials program should be renamed as the ‘Terry Beirn Community-Based AIDS Research Initiative’ in his honor.”

§300cc–13 Terry Beirn Community-Based AIDS Research Initiative