ESTABLISHMENT OF CERTAIN PROGRAMS.

SEC. 201. ESTABLISHMENT OF CERTAIN PROGRAMS. The Public Health Service Act (42 U.S.C. 201 et seq.) is amended— (1) by redesignating title XXIII as title XXV; (2) by redesignating sections 2301 through 2303 as sections 2501 through 2503, respectively; 102 STAT. 3063 (3) by redesignating sections 2306 through 2316 as sections 2504 through 2514, respectively; and (4) by inserting after title XXII the following new title: “TITLE XXIII—RESEARCH WITH RESPECT TO ACQUIRED IMMUNE DEFICIENCY SYNDROME “Part A—Administration of Research Programs “SEC. 2301. REQUIREMENT OF ANNUAL COMPREHENSIVE REPORT ON ALL EXPENDITURES BY SECRETARY WITH RESPECT TO ACQUIRED IMMUNE DEFICIENCY SYNDROME. “(a) In General.—Not later than December 1 of each fiscal year, the Secretary shall prepare and submit to the Congress a report on the expenditures by the Secretary of amounts appropriated for the preceding fiscal year with respect to acquired immune deficiency syndrome. “(b) Inclusion of Certain Information.—The report required in subsection (a) shall, with respect to acquired immune deficiency syndrome, include— “(1) for each program, project, or activity with respect to such syndrome, a specification of the amount obligated by each office and agency of the Department of Health and Human Services; “(2) a summary description of each such program, project, or activity; “(3) a list of such programs, projects, or activities that are directed towards members of minority groups; “(4) a description of the extent to which programs, projects, and activities described in paragraph (3) have been coordinated between the Director of the Office of Minority Health and the Director of the Centers for Disease Control; “(5) a summary of the progress made by each such program, project, or activity with respect to the prevention and control of acquired immune deficiency syndrome; “(6) a summary of the evaluations conducted under this title; and “(7) any report required in this Act to be submitted to the Secretary for inclusion in the report required in subsection (a). “SEC. 2302. REQUIREMENT OF EXPEDITING AWARDS OF GRANTS AND CONTRACTS FOR RESEARCH. “(a) In General.—The Secretary shall expedite the award of grants, contracts, and cooperative agreements for research projects relating to acquired immune deficiency syndrome (including such research projects initiated independently of any solicitation by the Secretary for proposals for such research projects). “(b) Time Limitations With Respect to Certain Applications.— “(1) With respect to programs of grants, contracts, and cooperative agreements described in subsection (a), any application submitted in response to a solicitation by the Secretary for proposals pursuant to such a program— “(A) may not be approved if the application is submitted after the expiration of the 3-month period beginning on the date on which the solicitation is issued; and “(B) shall be awarded, or otherwise finally acted upon, not later than the expiration of the 6-month period begin-102 STAT. 3064rung on me expiration oi me period aescriDea in suoparagraph (A). “(2) If the Secretary makes a determination that it is not practicable to administer a program referred to in paragraph (1) in accordance with the time limitations described in such paragraph, the Secretary may adjust the time limitations accordingly. “(c) Requirements With Respect to Adjustments in Time Limitations.—With respect to any program for which a determination described in subsection (b)(2) is made, the Secretary shall— “(1) if the determination is made before the Secretary issues a solicitation for proposals pursuant to the program, ensure that the solicitation describes the time limitations as adjusted by the determination; and “(2) if the determination is made after the Secretary issues such a solicitation for proposals, issue a statement describing the time limitations as adjusted by the determination and individually notify, with respect to the determination, each applicant whose application is submitted before the expiration of the 3-month period beginning on the date on which the solicitation was issued. “(d) Annual Reports to Congress.—Except as provided in subsection (e), the Secretary shall annually prepare, for inclusion in the comprehensive report required in section 2301, a report— “(A) summarizing programs for which the Secretary has made a determination described in subsection (b)(2), including a description of the time limitations as adjusted by the determination and including a summary of the solicitation issued by the Secretary for proposals pursuant to the program; and “(B) summarizing applications that— “(i) were submitted pursuant to a program of grants, contracts, or cooperative agreements referred to in paragraph (1) of subsection (b) for which a determination described in paragraph (2) of such subsection has not been made; and “(ii) were not processed in accordance with the time limitations described in such paragraph (1). “(e) Quarterly Reports for Fiscal Year 1989.—For fiscal year 1989, the report required in subsection (d) shall, not less than quarterly, be prepared and submitted to the Committee on Energy and Commerce of the House of Representatives and the Committee on Labor and Human Resources of the Senate. “SEC. 2303. 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. 102 STAT. 3065 “(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. 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 re-search 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 102 STAT. 3066syndrome, 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. 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 treatment 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. USE OF INVESTIGATIONAL NEW DRUGS WITH RESPECT TO ACQUIRED IMMUNE DEFICIENCY SYNDROME “(a) Encouragement of Applications With Respect to Clinical Trials.— “(1) If, tn 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 102 STAT. 3067deficiency 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. 102 STAT. 3068 “SEC. 2313. 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 implement 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 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 102 STAT. 3069information 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. 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 respect to acquired immune deficiency syndrome that are approved by the Commissioner of Food and Drugs. “(b) Authority With Respect to Grants and Contracts.— “(1) For the purpose of conducting evaluations required in subsection (a), the Secretary may make grants to, and enter into cooperative agreements and contracts with, public and non-profit private entities. “(2) Nonprofit private entities under paragraph (1) may include nonprofit private organizations that— “(A) are established for the purpose of evaluating treatments with respect to acquired immune deficiency syndrome; and “(B) consist primarily of individuals infected with the etiologic agent for such syndrome. “(c) Scientific and Ethical Guidelines.— “(1) The Secretary shall establish appropriate scientific and ethical guidelines for the conduct of evaluations carried out pursuant to this section. The Secretary may not provide financial assistance under subsection (b)(1) unless the applicant for such assistance agrees to comply with such guidelines. “(2) The Secretary may establish the guidelines described in paragraph (1) only after consulting with— “(A) physicians whose clinical practice includes a significant number of individuals with acquired immune deficiency syndrome; “(B) individuals who are infected with the etiologic agent for such syndrome; and “(C) other individuals with appropriate expertise or experience. “(d) Authorization of Appropriations.—For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary. 102 STAT. 3070 “SEC. 2315. SUPPORT OF INTERNATIONAL EFFORTS. “(a) Grants and Contracts for Research.— “(1) Under section 307, the Secretary, acting through the Director of the National Institutes of Health— “(A) shall, for the purpose described in paragraph (2), make grants to, enter into cooperative agreements and contracts with, and provide technical assistance to, international organizations concerned with public health; and “(B) may, for such purpose, provide technical assistance to foreign governments. “(2) The purpose refered to in paragraph (1) is promoting and expediting international research concerning the development and evaluation of vaccines and treatments for acquired immune deficiency syndrome. “(b) Grants and Contracts for Additional Purposes.—After consultation with the Administrator of the Agency for International Development, the Secretary, acting through the Director of the Centers for Disease Control, shall under section 307 make grants to, enter into contracts with, and provide technical assistance to, international organizations concerned with public health and may provide technical assistance to foreign governments, in order to support— “(1) projects for training individuals with respect to developing skills and technical expertise for use in the prevention, diagnosis, and treatment of acquired immune deficiency syndrome; and “(2) epidemiological research relating to acquired immune deficiency syndrome. “(c) Special Programme of World Health Organization.—Support provided by the Secretary pursuant to this section shall be in furtherance of the global strategy of the World Health Organization Special Programme on Acquired Immunodeficiency Syndrome. “(d) Preferences.—In providing grants, cooperative agreements, contracts, and technical assistance under subsections (a) and (b), the Secretary shall— “(1) give preference to activities under such subsections conducted by, or in cooperation with, the World Health Organization; and “(2) with respect to activities carried out under such subsections in the Western Hemisphere, give preference to activities conducted by, or in cooperation with, the Pan American Health Organization or the World Health Organization. “(e) Requirement of Application.—The Secretary may not make a grant or enter into a cooperative agreement or contract under this section unless— “(1) an application for such assistance is submitted to the Secretary; “(2) with respect to carrying out the purpose for which such assistance is to be provided, 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. “(f) Authorization of Appropriations.—For the purpose of carrying out this section, there are authorized to be appropriated 102 STAT. 3071$40,000,000 for fiscal year 1989 and such sums as may be necessary for each of the fiscal years 1990 and 1991. “SEC 2316. RESEARCH CENTERS. “(a) In General.— “(1) The Secretary, acting through the Director of the National Institute of Allergy and Infectious Diseases, may make grants to, and enter into contracts with, public and nonprofit private entities to assist such entities in planning, establishing, or strengthening, and providing basic operating support for, centers for basic and clinical research into, and training in, advanced diagnostic, prevention, and treatment methods for acquired immune deficiency syndrome. “(2) A grant or contract under paragraph (1) shall be provided in accordance with policies established by the Secretary, acting through the Director of the National Institutes of Health, and after consultation with the advisory council for the National Institute of Allergy and Infectious Diseases. “(3) The Secretary shall ensure that, as appropriate, clinical research programs carried out under paragraph (1) include as research subjects women, children, hemophiliacs, and minorities. “(b) Use of Financial Assistance.— “(1) Financial assistance under subsection (a) may be expended for— “(A) the renovation or leasing of space; “(B) staffing and other basic operating costs, including such patient care costs as are required for clinical research; “(C) clinical training with respect to acquired immune deficiency syndrome (including such training for allied health professionals); and “(D) demonstration purposes, including projects in the long-term monitoring and outpatient treatment of individuals infected with the etiologic agent for such syndrome. “(2) Financial assistance under subsection (a) may not be expended to provide research training for which National Research Service Awards may be provided under section 487. “(c) Duration of Support.—Support of a center under subsection (a) may be for not more than five years. Such period may be extended by the Director for additional periods of not more than five years each if the operations of such center have been reviewed by an appropriate technical and scientific peer review group established by the Director and if such group has recommended to the Director that such period should be extended. “(d) Authorization of Appropriations.—For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary. “SEC 2317. INFORMATION SERVICES. “(a) Establishment of Program.—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) Toll-Free Telephone Communications for Health Care Entities.— 102 STAT. 3072 “(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) 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) Data Bank on Research Information.— “(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 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) Data Bank on Clinical Trials and Treatments.— “(1) After 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 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) 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 syndrome 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 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. 102 STAT. 3073 “(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. “SEC. 2318. DEVELOPMENT OF MODEL PROTOCOLS FOR CLINICAL CARE OF INFECTED INDIVIDUALS. “(a) In General.— “(1) The Secretary may make grants to public and nonprofit private entities for the establishment of projects to develop model protocols for the clinical care of individuals infected with the etiologic agent for acquired immune deficiency syndrome. “(2) The Secretary may not make a grant under paragraph (1) unless— “(A) the applicant for the grant is a provider of comprehensive primary care; or “(B) the applicant for the grant agrees, with respect to the project carried out pursuant to paragraph (1), to enter into a cooperative arrangement with an entity that is a provider of comprehensive primary care. “(b) Requirement of Provision of Certain Services.—The Secretary may not make a grant under subsection (a) unless the applicant for the grant agrees that, with respect to patients participating in the project carried out with the grant, services provided pursuant to the grant will include— “(1) monitoring, in clinical laboratories, of the condition of such patients; “(2) clinical intervention for infection with the etiologic agent for acquired immune deficiency syndrome, including measures for the prevention of conditions arising from the infection; “(3) information and counseling on the availability of treatments for such infection approved by the Commissioner of Food and Drugs, on the availability of treatments for such infection not yet approved by the Commissioner, and on the reports issued by the Clinical Research Review Committee under section 2304(cX2XB); “(4) support groups; and “(5) information on, and referrals to, entities providing appropriate social support services. “(c) Limitation on Imposition of Charges for Services.—The Secretary may not make a grant under subsection (a) unless the applicant for the grant agrees that, if the applicant will routinely impose a charge for providing services pursuant to the grant, the applicant will not impose the charge on any individual seeking such services who is unable to pay the charge. “(d) Evaluation and Reports.— “(1) The Secretary may not make a grant under subsection (a) unless the applicant for the grant agrees, with respect to the project carried out pursuant to subsection (a), to submit to the Secretary— 102 STAT. 3074 “(A) information sufficient to assist in the replication of the model protocol developed pursuant to the project; and “(B) such reports as the Secretary may require. “(2) The Secretary shall provide for evaluations of projects carried out pursuant to subsection (a) and shall annually submit to the Congress a report describing such projects. The report shall include the findings made as a result of such evaluations and may include any recommendations of the Secretary for appropriate administrative and legislative initiatives with respect to the program established in this section. “(e) Authorization of Appropriations.—For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 1989 through 1991. “SEC. 2319. NATIONAL BLOOD RESOURCE EDUCATION PROGRAM. “After consultation with the Director of the National Heart, Lung, and Blood Institute and the Commissioner of Food and Drugs, the Secretary shall establish a program of research and education regarding blood donations and transfusions to maintain and improve the safety of the blood supply. Education programs shall be directed at health professionals, patients, and the community to— “(1) in the case of the public and patients undergoing treatment— “(A) increase awareness that the process of donating blood is safe; “(B) promote the concept that blood donors are contributors to a national need to maintain an adequate and safe blood supply; “(C) encourage blood donors to donate more than once a year; and “(D) encourage repeat blood donors to recruit new donors; “(2) in the case of health professionals— “(A) improve knowledge, attitudes, and skills of health professionals in the appropriate use of blood and blood components; “(B) increase the awareness and understanding of health professionals regarding the risks versus benefits of blood transfusion; and “(C) encourage health professionals to consider alter-natives to the administration of blood or blood components for their patients; and “(3) in the case of the community, increase coordination, communication, and collaboration among community, professional, industry, and government organizations regarding blood donation and transfusion issues. “SEC. 2320. ADDITIONAL AUTHORITY WITH RESPECT TO RESEARCH. “(a) Data Collection With Respect to National Prevalence.— “(1) The Secretary, acting through the Director of the Centers for Disease Control, may, through representative sampling and other appropriate methodologies, provide for the continuous collection of data on the incidence in the United States of cases of acquired immune deficiency syndrome and of cases of infection with the etiologic agent for such syndrome. The Secretary may carry out the program of data collection directly or 102 STAT. 3075through cooperative agreements and contracts with public and nonprofit private entities. “(2) The Secretary shall encourage each State to enter into a cooperative agreement or contract under paragraph (1) with the Secretary in order to facilitate the prompt collection of the most recent accurate data on the incidence of cases described in such paragraph. “(3) The Secretary shall ensure that data collected under paragraph (1) includes data on the demographic characteristics of the population of individuals with cases described in paragraph (1), including data on specific subpopulations at risk of infection with the etiologic agent for acquired immune deficiency syndrome. “(4) In carrying out this subsection, the Secretary shall, for the purpose of assuring the utility of data collected under this section, request entities with expertise in the methodologies of data collection to provide, as soon as is practicable, assistance to the Secretary and to the States with respect to the development and utilization of uniform methodologies of data collection. “(5) The Secretary shall provide for the dissemination of data collected pursuant to this section. In carrying out this paragraph, the Secretary may publish such data as frequently as the Secretary determines to be appropriate with respect to the protection of the public health. The Secretary shall publish such data not less than once each year. “(b) Epidemiological and Demographic Data.— “(1) The Secretary, acting through the Director of the Centers for Disease Control, shall develop an epidemiological data base and shall provide for long-term studies for the purposes of— “(A) collecting information on the demographic characteristics of the population of individuals infected with the etiologic agent for acquired immune deficiency syndrome; and “(B) developing models demonstrating the long-term domestic and international patterns of the transmission of such etiologic agent. “(2) The Secretary may carry out paragraph (1) directly or through grants to, or cooperative agreeements or contracts with, public and nonprofit private entities, including Federal agencies. “(c) Long-Term Research.—The Secretary may make grants to public and nonprofit private entities for the purpose of assisting grantees in conducting long-term research into treatments for acquired immune deficiency syndrome developed from knowledge of the genetic nature of the etiologic agent for such syndrome. “(d) Social Sciences Research.—The Secretary, acting through the Director of the National Institute of Mental Health, may make grants to public and nonprofit private entities for the purpose of assisting grantees in conducting scientific research into the psycho-logical and social sciences as such sciences relate to acquired immune deficiency syndrome. “(e) Authorization of Appropriations.— “(1) For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 1989 through 1991. “(2) Amounts appropriated pursuant to paragraph (1) to carry out subsection (c) snail remain available until expended. 102 STAT. 3076 “Part C—Research Training “SEC 2341. FELLOWSHIPS AND TRAINING. “(a) In General.—The Secretary, acting through the Director of the Centers for Disease Control, shall establish fellowship and training programs to be conducted by the Centers for Disease Control to train individuals to develop skills in epidemiology, surveillance, testing, counseling, education, information, and Laboratory analysis relating to acquired immune deficiency syndrome. Such programs shall be designed to enable health professionals and health personnel trained under such programs to work, after receiving such training, in national and international efforts toward the prevention, diagnosis, and treatment of acquired immune deficiency syndrome. “(b) Programs Conducted by National Institute of Mental Health.—The Secretary, acting through the Director of the National Institute of Mental Health, shall conduct or support fellow-ship and training programs for individuals pursuing graduate or postgraduate study in order to train such individuals to conduct scientific research into the psychological and social sciences as such sciences relate to acquired immune deficiency syndrome. “(c) Relationship to Limitation on Number of Employees.—Any individual receiving a fellowship or receiving training under subsection (a) or (b) shall not be included in any determination of the number of hill-time equivalent employees of the Department of Health and Human Services for the purpose of any limitation on the number of such employees established by law prior to, on, or after the date of the enactment of the AIDS Federal Policy Act of 1988. “(d) Authorization of Appropriations.—For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 1989 through 1991. “Part D—Special Authorities of the Director of the National Institutes of Health “SEC. 2351 ESTABLISHMENT OF AUTHORITIES. “(a) In General.—In carrying out research with respect to acquired immune deficiency syndrome, the Secretary, acting through the Director of the National Institutes of Health— “(1)(A) shall establish an office to be known as the Office of AIDS Research, which Office shall be headed by a Director appointed by the Director of the National Institutes of Health; and “(B) shall provide administrative support and support services to the Director of such Office; “(2) shall coordinate activities relating to acquired immune deficiency syndrome conducted by the national research institutes and the agencies of the National Institutes of Health; “(3) shall develop and expand clinical trials of treatments and therapies for infection with the etiologic agent for acquired immune deficiency syndrome, including such clinical trials for women, infants, children, hemophiliacs, and minorities; “(4) may establish or support the large-scale development and preclinical screening, production, or distribution of specialized biological materials and other therapeutic substances for 102 STAT. 3077research relating to acquired immune deficiency syndrome and set standards of safety and care for persons using such materials; “(5) may, in consultation with the advisory council for the appropriate national research institute of the National Institutes of Health, support— “(A) research relating to acquired immune deficiency syndrome conducted outside the United States by qualified foreign professionals if such research can reasonably be expected to benefit the people of the United States; “(B) collaborative research involving American and foreign participants; and “(C) the training of American scientists abroad and foreign scientists in the United States; “(6) may encourage and coordinate research relating to acquired immune deficiency syndrome conducted by any industrial concern that evidences a particular capability for the conduct of such research; “(7)(A) may, in consultation with such advisory council, acquire, improve, repair, operate, and maintain laboratories, other research facilities, equipment, and such other real or personal property as the Director of the National Institutes of Health determines necessary; “(B) may, in consultation with such advisory council, make grants for the construction or renovation of facilities; and “(C) may, in consultation with such advisory council, acquire, without regard to the Act of March 3, 1877 (40 U.S.C. 34) by lease or otherwise through the Administrator of General Services, buildings or parts of buildings in the District of Columbia or communities located adjacent to the District of Columbia for the use of the National Institutes of Health for a period not to exceed ten years; and “(8) subject to section 405(b)(2) and without regard to section 3324 of title 31, United States Code, and section 3709 of the Revised Statutes (41 U.S.C. 5), may enter into such contracts and cooperative agreements with any public agency, or with any person, firm, association, corporation, or educational institution, as may be necessary to expedite and coordinate research relating to acquired immune deficiency syndrome. “(b) Report to Secretary.—The Director of the National Institutes of Health, acting through the Director of the Office of AIDS Research, shall each fiscal year prepare and submit to the Secretary, for inclusion in the comprehensive report required in section 2301(a), a report— “(1) describing and evaluating the progress made in such fiscal year in research, treatment, and training with respect to acquired immune deficiency syndrome conducted or supported by the Institutes; “(2) summarizing and analyzing expenditures made in such fiscal year for activities with respect to acquired immune deficiency syndrome conducted or supported by the National Institutes of Health; and “(3) containing such recommendations as the Director considers appropriate. “(c) Projects for Cooperation Among Public and Private Health Entities.—In carrying out subsection (a), the Director of the National Institutes of Health shall establish projects to promote 102 STAT. 3078cooperation among Federal agencies, State, local, and regional public health agencies, and private entities, in research concerning the diagnosis, prevention, and treatment of acquired immune deficiency syndrome. “Part E—General Provisions “SEC. 2361. DEFINITION. “For purposes of this title, the term ‘infection with the etiologic agent for acquired immune deficiency syndrome’ includes any condition arising from infection with such etiologic agent.”.