Page:United States Statutes at Large Volume 114 Part 2.djvu/472

 114 STAT. 1354 PUBLIC LAW 106-345—OCT. 20, 2000 (2) REPORT TO CONGRESS.—The Director of NIH shall periodically submit to the appropriate committees of Congress a report describing the research and other activities conducted or supported under paragraph (1). (3) AUTHORIZATION OF APPROPRIATIONS. — For the purpose of carrying out this subsection, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2001 through 2005. (b) PREMARKET REVIEW OF RAPID HIV TESTS. — Deadline. (1) IN GENERAL. — Not later than 90 days after the date of the enactment of this Act, the Secretary, in consultation with the Director of the Centers for Disease Control and Prevention and the Commissioner of Food and Drugs, shall submit to the appropriate committees of the Congress a report describing the progress made towards, and barriers to, the premarket review and commercial distribution of rapid HIV tests. The report shall— (A) assess the public health need for and public health benefits of rapid HIV tests, including the minimization of false positive results through the availability of multiple rapid HIV tests; (B) make recommendations regarding the need for the expedited review of rapid HIV test applications submitted to the Center for Biologies Evaluation and Research and, if such recommendations are favorable, specify criteria and procedures for such expedited review; and (C) specify whether the barriers to the premarket review of rapid HFV tests include the unnecessary application of requirements— (i) necessary to ensure the efficacy of devices for donor screening to rapid HIV tests intended for use in other screening situations; or (ii) for identifying antibodies to HIV subtypes of rare incidence in the United States to rapid HIV tests intended for use in screening situations other than donor screening. (c) GUIDELINES OF CENTERS FOR DISEASE CONTROL AND PREVENTION. —Promptly after commercial distribution of a rapid HIV test begins, the Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall establish or update guidelines that include recommendations for States, hospitals, and other appropriate entities regarding the ready availability of such tests for administration to pregnant women who are in labor or in the late stage of pregnancy and whose HIV status is not known to the attending obstetrician. SEC. 503. TECHNICAL CORRECTIONS. (a) PUBLIC HEALTH SERVICE ACT. —Title XXVI of the Public Health Service Act (42 U.S.C. 300ff-ll et seq.) is amended— 42 USC 300ff-l5. (1) in section 2605(d)— (A) in paragraph (1), by striking "section 2608" and inserting "section 2677"; and (B) in paragraph (4), by inserting "section" before " 2601(a)"; and 42 USC 300ff-73. (2) in section 2673(a), in the matter preceding paragraph (1), by striking "the Agency for Health Care Policy and

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