Page:United States Statutes at Large Volume 102 Part 4.djvu/96

 102 STAT. 3066

PUBLIC LAW 100-607—NOV. 4, 1988 syndrome, including treatment with the drugs described in paragraph (1^ and "(4) conduct a study for the purpose of developing, with respect to individuals infected with the etiologic agent for acquued immune deficiency syndrome, a consensus among health care professionals on clinical treatments for preventing or minimizing the development of i^mptoms or conditions arising from infection with such etiologic agent.
 * PABT B—RESEARCH AUTHORITY

42 USC

"SEC 2311. CLINICAL EVALUATION UNITS AT NATIONAL INSTITUTES OF

300CC-11.

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; and "(2) may conduct clini<^ 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 AoMiNisTRATiyE SUPPORT.—

"(1) For the purposes described in subsection (a), the Secretary, acting tlux>ugh the Director of the National Institutes of Health, shall provide each of the clinical evaluation units required in such subsection— "(AKi) 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

42 USC 300CC-12.

carrying out this section, there are authorized to be appropriated such sums as may be necessary. "SEC 2312. USE OF INVESTIGATIONAL NEW DRUGS WITH RESPECT TO ACQUIRED IMMUNE DEFICIENCY SYNDROME. "(a) ENCOURAGEMENT OF APPLICATIONS W I T H RESPECT TO C U N I C A L TRIALS,—

Federal ^®^^f: pu ica ion.

"(1) If, in the determination of the Secretary, there is preliminary evidence that a new drug has effectiveness in humans with respect to the prevention or treatment of acquired immune

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