SEC. 2303. [300cc-2] REQUIREMENTS WITH RESPECT TO PROCESSING OF REQUESTS FOR PERSONNEL AND ADMINISTRATIVE SUPPORT. (a) IN GENERAL.-The Director of the Office of Personnel Management or the Administrator of General Services, as the case may be, shall respond to any priority request made by the Administrator of the Alcohol, Drug Abuse, and Mental Health Administration, the Director of the Centers for Disease Control, the Commissioner of Food and Drugs, or the Director of the National Institutes of Health, not later than 21 days after the date on which such request is made. If the Director of the Office of Personnel Management or the Administrator of General Services, as the case may be, does not disapprove a priority request during the 21-day period, the request shall be deemed to be approved. (b) NOTICE TO SECRETARY AND TO ASSISTANT SECRETARY FOR HEALTH.-The Administrator of the Alcohol, Drug Abuse, and Mental Health Administration, the Director of the Centers for Disease Control, the Commissioner of Food and Drugs, and the Director of the National Institutes of Health, shall, respectively, transmit to the Secretary and the Assistant Secretary for Health a copy of each priority request made under this section by the agency head involved. The copy shall be transmitted on the date on which the priority request involved is made. (c) DEFINITION OF PRIORITY REQUEST.-For purposes of this section, the term "priority request" means any request that (1) is designated as a priority request by the Administrator of the Alcohol, Drug Abuse, and Mental Health Administration, the Director of the Centers for Disease Control, the Commissioner of Food and Drugs, or the Director of the National Institutes of Health; and (2)(A) is made to the Director of the Office of Personnel Management for the allocation of personnel to carry out activities with respect to acquired immune deficiency syndrome; or (B) is made to the Administrator of General Services for administrative support or space in carrying out such activities. SEC. 2304. [300cc-3] ESTABLISHMENT OF CLINICAL RESEARCH REVIEW COMMITTEE. (a) IN GENERAL.-After consultation with the Commissioner of Food and Drugs, the Secretary, acting through the Director of the National Institute of Allergy and Infectious Diseases, shall establish within such Institute an advisory committee to be known as the AIDS Clinical Research Review Committee (hereafter in this section referred to as the "Committee"). (b) COMPOSITION.-The Committee shall be composed of physicians whose clinical practice includes a significant number of patients with acquired immune deficiency syndrome. (c) DUTIES.-The Committee shall (1) advise the Director of such Institute on appropriate research activities to be undertaken with respect to clinical treatment of such syndrome, including advice with respect to (A) research on drugs for preventing or minimizing the development of symptoms or conditions arising from infection with the etiologic agent for such syndrome; and (B) research on the effectiveness of treating such symptoms or conditions with drugs that— (i) are not approved by the Commissioner of Food and Drugs for the purpose of treating such symptoms or conditions; and (ii) are being utilized for such purpose by individuals infected with such etiologic agent; (2)(A) review ongoing publicly and privately supported research on clinical treatment for acquired immune deficiency syndrome, including research on drugs described in paragraph (1); and (B) periodically issue, and make available to health care professionals, reports describing and evaluating such research; (3) conduct studies and convene meetings for the purpose of determining the recommendations among physicians in clinical practice on clinical treatment of acquired immune deficiency 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 acquired immune deficiency syndrome, a consensus among health care professionals on clinical treatments for preventing or minimizing the development of symptoms or conditions arising from infection with such etiologic agent. PART B-RESEARCH AUTHORITY SEC. 2311. [300cc-11] CLINICAL EVALUATION UNITS AT NATIONAL INSTITUTES OF 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 clinical 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 ADMINISTRATIVE SUPPORT. (1) For the purposes described in subsection (a), the Secretary, acting through the Director of the National Institutes of Health, shall provide each of the clinical evaluation units required in such subsection (A)(i) 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 carrying out this section, there are authorized to be appropriated such sums as may be necessary. SEC. 2312. [300cc-12] USE OF INVESTIGATIONAL NEW DRUGS WITH RE- (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 deficiency syndrome, the Secretary shall, through statements published in the Federal Register (A) announce the fact of such determination; and (B) with respect to the new drug involved, encourage an application for an exemption for investigational use of the new drug under regulations issued under section 505(i) of the Federal Food, Drug, and Cosmetic Act. (2)(A) The AIDS Clinical Research Review Committee established pursuant to section 2304 shall make recommendations to the Secretary with respect to new drugs appropriate for determinations described in paragraph (1). (B) The Secretary shall, as soon as is practicable, determine the merits of recommendations received by the Secretary pursuant to subparagraph (A). (b) ENCOURAGEMENT OF APPLICATIONS WITH RESPECT TO TREATMENT USE IN CIRCUMSTANCES OTHER THAN CLINICAL TRIALS. (1) In the case of a new drug with respect to which the Secretary has made a determination described in subsection (a) and with respect to which an exemption is in effect for purposes of section 505(i) of the Federal Food, Drug, and Cosmetic Act, the Secretary shall (A) as appropriate, encourage the sponsor of the investigation of the new drug to submit to the Secretary, in accordance with regulations issued under such section, an application to use the drug in the treatment of individuals (i) who are infected with the etiologic agent for acquired immune deficiency syndrome; and (ii) who are not participating in the clinical trials conducted pursuant to such exemption; and (B) if such an application is approved, encourage, as appropriate, licensed medical practitioners to obtain, in accordance with such regulations, the new drug from such sponsor for the purpose of treating such individuals. (2) If the sponsor of the investigation of a new drug described in paragraph (1) does not submit to the Secretary an application described in such paragraph (relating to treatment use), the Secretary shall, through statements published in the Federal Register, encourage, as appropriate, licensed medical practitioners to submit to the Secretary such applications in accordance with regulations described in such paragraph. (c) TECHNICAL ASSISTANCE WITH RESPECT TO TREATMENT USE.-In the case of a new drug with respect to which the Secretary has made a determination described in subsection (a), the Secretary may, directly or through grants or contracts, provide technical assistance with respect to the process of― (1) submitting to the Secretary applications for exemptions described in paragraph (1)(B) of such subsection; (2) submitting to the Secretary applications described in subsection (b); and (3) with respect to sponsors of investigations of new drugs, facilitating the transfer of new drugs from such sponsors to licensed medical practitioners. (d) DEFINITION.-For purposes of this section, the term "new drug" has the meaning given such term in section 201 of the Federal Food, Drug, and Cosmetic Act. SEC. 2313. [300cc-13] COMMUNITY-BASED EVALUATIONS OF EXPERIMENTAL THERAPIES. (a) IN GENERAL.-After consultation with the Commissioner of Food and Drugs, the Director of the National Institutes of Health, acting through the National Institute of Allergy and Infectious Diseases, may make grants to public entities and nonprofit private entities concerned with acquired immune deficiency syndrome, and may enter into contracts with public and private such entities, for the purpose of planning and conducting, in the community involved, clinical trials of experimental treatments for infection with the etiologic agent for such syndrome that are approved by the Commissioner of Food and Drugs for investigational use under regulations issued under section 505 of the Federal Food, Drug, and Cosmetic Act. (b) REQUIREMENT OF CERTAIN PROJECTS. (1) Financial assistance under subsection (a) shall include such assistance to community-based organizations and community health centers for the purpose of (A) retaining appropriate medical supervision; (B) assisting with administration, data collection and record management; and (C) conducting training of community physicians, nurse practitioners, physicians' assistants and other health professionals for the purpose of conducting clinical trials. (2)(A) Financial assistance under subsection (a) shall include such assistance for demonstration projects designed to imple 1 So in original. Probably should be "acting through the Director of the National Institute". (Section 2617(b)(1) of Public Law 100-690 expressed the intent to so amend the provision; however, the amendment cannot be executed because the amendatory instructions are to strike "through the National Institutes of Allergy", and this term does not appear in subsection (a) (above).) ment and conduct community-based clinical trials in order to provide access to the entire scope of communities affected by infections with the etiologic agent for acquired immune deficiency syndrome, including minorities, hemophiliacs and transfusion-exposed individuals, women, children, users of intravenous drugs, and individuals who are asymptomatic with respect to such infection. (B) The Director of the National Institutes of Health may not provide financial assistance under this paragraph unless the application for such assistance is approved (i) by the Commissioner of Food and Drugs; (ii) by a duly constituted Institutional Review Board that meets the requirements of part 56 of title 21, Code of Federal Regulations; and (iii) by the Director of the National Institute of Allergy and Infectious Diseases. (c) PARTICIPATION OF PRIVATE INDUSTRY AND SCHOOLS OF MEDICINE.-Programs carried out with financial assistance provided under subsection (a) shall be designed to encourage private industry and schools of medicine and osteopathic medicine to participate in, and to support, the clinical trials conducted pursuant to the programs. (d) REQUIREMENT OF APPLICATION.-The Secretary may not provide financial assistance under subsection (a) unless (1) an application for the assistance is submitted to the Secretary; (2) with respect to carrying out the purpose for which the assistance is to be made, the application provides assurances of compliance satisfactory to the Secretary; and (3) the application otherwise is in such form, is made in such manner, and contains such agreements, assurances, and information as the Secretary determines to be necessary to carry out this section. (e) AUTHORIZATION OF APPROPRIATIONS.— (1) For the purpose of carrying out subsection (b)(1), there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 1989 through 1991. (2) For the purpose of carrying out subsection (b)(2), there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 1989 through 1991. SEC. 2314. [300cc-14] EVALUATION OF CERTAIN TREATMENTS. (a) ESTABLISHMENT OF PROGRAM. (1) After consultation with the Clinical Research Review Committee established pursuant to section 2304, the Secretary shall establish a program for the evaluation of drugs that— (A) are not approved by the Commissioner of Food and Drugs for the purpose of treatments with respect to acquired immune deficiency syndrome; and (B) are being utilized for such purpose by individuals infected with the etiologic agent for such syndrome. (2) The program established under paragraph (1) shall include evaluations of the effectiveness and the risks of the treatment involved, including the risks of foregoing treatments with |