Page:United States Statutes at Large Volume 102 Part 4.djvu/102

 102 STAT. 3072

PUBLIC LAW 100-607—NOV. 4, 1988 "(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, 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) Loformation 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 sjmdrome; and ''(B) information contained in the data banks established in subsections (c) and (d). "(c) DATA BANK ON RESEARCH iNFORBfATioN.—

"(1) After consultation with the Director of the Office of AIDS Research, the Director of the Centers for Disease Control, 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 canning 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) DATA BANK ON CLINICAL TRIALS AND TREATBCENTS.—

"(1) Afl»r consultation with the (Commissioner of Food and Drugs, the Clinical Research Review Committee, 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 tins section referred to as the 'Data Bcuok'). "(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 witii the etiologic agent for acquired immune deficiency syndrome, to other members of the public, to health care providers, and to researchers. "(e) REQUIREMENTS WITH RESPECT TO DATA BANK.—The Data Bank shall include the following: "(1) A registry of clinical trials of experimental treatments for acquired immune deficiency i^ndrome and related illnesses conducted under regulations promulgated pursuant to section 505 of the Federal Food, Drug and Cosmetic Act 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 t«3t efficacy b^ins. Information provided shall include eligibiti^ criteria and the location of trial sites, and must be foiTK^utled to the Data Bank by the sponsor of the trial not later than 21 days after the approval by the Food and Drug Administration.

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