PRIA, Government Policy, Made Personal

Summary

Create and run a program to collect and share information about research, treatment, and ways to prevent infection with the virus that causes AIDS. The program must be coordinated across Health and Human Services. It must offer a toll-free phone line for doctors, nurses, allied health staff, and emergency health workers to get medical and technical information. The phone service must cover how to prevent exposure and use the program’s data banks. Set up two data banks. One holds research results from the United States and other countries and should be made available to researchers, doctors, and others. The other, called the Data Bank, holds information on clinical trials and treatments and must be shared with patients, the public, health providers, and researchers. The Data Bank must include a registry of experimental treatment trials with the purpose, who can join, and where the trial is happening; trial sponsors must send that information to the Data Bank within 21 days after FDA approval under section 355 of title 21. It must also include info on investigational treatments submitted to the FDA under part 312 and, with the sponsor’s consent, trial results and known toxicities or side effects.

Title 42, §300cc–17

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

(a)The Secretary shall establish, maintain, and operate a program with respect to information on research, treatment, and prevention activities relating to infection with the etiologic agent for acquired immune deficiency syndrome. The program shall, with respect to the agencies of the Department of Health and Human Services, be integrated and coordinated.

(b)(1)After consultation with the Director of the Office of AIDS Research, the Administrator of the Health Resources and Services Administration, and the Director of the Centers for Disease Control and Prevention, the Secretary shall provide for toll-free telephone communications to provide medical and technical information with respect to acquired immune deficiency syndrome to health care professionals, allied health care providers, and to professionals providing emergency health services.

(2)Information provided pursuant to paragraph (1) shall include—

(A)information on prevention of exposure to, and the transmission of, the etiologic agent for acquired immune deficiency syndrome; and

(B)information contained in the data banks established in subsections (c) and (d).

(c)(1)After consultation with the Director of the Office of AIDS Research, the Director of the Centers for Disease Control and Prevention, and the National Library of Medicine, the Secretary shall establish a data bank of information on the results of research with respect to acquired immune deficiency syndrome conducted in the United States and other countries.

(2)In carrying out paragraph (1), the Secretary shall collect, catalog, store, and disseminate the information described in such paragraph. To the extent practicable, the Secretary shall make such information available to researchers, physicians, and other appropriate individuals, of countries other than the United States.

(d)(1)After consultation with the Commissioner of Food and Drugs, the AIDS Research Advisory Committee established under section 300cc–3 of this title, and the Director of the Office of AIDS Research, the Secretary shall, in carrying out subsection (a), establish a data bank of information on clinical trials and treatments with respect to infection with the etiologic agent for acquired immune deficiency syndrome (hereafter in this section referred to as the “Data Bank”).

(2)In carrying out paragraph (1), the Secretary shall collect, catalog, store, and disseminate the information described in such paragraph. The Secretary shall disseminate such information through information systems available to individuals infected with the etiologic agent for acquired immune deficiency syndrome, to other members of the public, to health care providers, and to researchers.

(e)The Data Bank shall include the following:

(1)A registry of clinical trials of experimental treatments for acquired immune deficiency syndrome and related illnesses conducted under regulations promulgated pursuant to section 355 of title 21 that provides a description of the purpose of each experimental drug protocol either with the consent of the protocol sponsor, or when a trial to test efficacy begins. Information provided shall include eligibility criteria and the location of trial sites, and must be forwarded to the Data Bank by the sponsor of the trial not later than 21 days after the approval by the Food and Drug Administration.

(2)Information pertaining to experimental treatments for acquired immune deficiency syndrome that may be available under a treatment investigational new drug application that has been submitted to the Food and Drug Administration pursuant to part 312 of title 21, Code of Federal Regulations. The Data Bank shall also include information pertaining to the results of clinical trials of such treatments, with the consent of the sponsor, of such experimental treatments, including information concerning potential toxicities or adverse effects associated with the use or administration of such experimental treatment.

Notes & Related Subsidiaries

Editorial Notes

Amendments

1993—Subsec. (d)(1). Pub. L. 103–43 substituted “AIDS Research Advisory Committee established under section 300cc–3 of this title” for “Clinical Research Review Committee”. 1992—Subsecs. (b)(1), (c)(1). Pub. L. 102–531 substituted “Centers for Disease Control and Prevention” for “Centers for Disease Control”. 1988—Subsec. (e). Pub. L. 100–690 substituted “data bank on clinical trials and treatments” for “data bank” in heading.

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.

§300cc–17 Information Services