§300cc–17 — Title 42 The Public Health and Welfare | U.S. Code

Summary

The Secretary must set up and run a program that gives information about research, treatment, and ways to prevent infection with the agent that causes AIDS. The program must be coordinated across the Department of Health and Human Services. After talking with the Office of AIDS Research director, the Health Resources and Services Administration leader, and the CDC director, the Secretary must provide a toll-free phone line for medical and technical information for doctors, allied health workers, and emergency health staff. That phone service must cover how to prevent exposure and spread, and must use the information in two special data banks. One data bank will collect and share results of AIDS research done in the United States and other countries and make those results available to researchers and doctors, and to others when possible. The second "Data Bank" will collect and share 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 purpose, who can join, and site locations. Trial sponsors must send that registry entry to the Data Bank not later than 21 days after FDA approval. The Data Bank must also include information on treatments under investigational new drug applications (part 312) and, with sponsor consent, trial results and any toxicities or adverse 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