Fetal Tissue Research bill

TABLE OF CONTENTS:

Title I: General Provisions Regarding Title IV of Public

Health Service Act

Title II: National Institutes of Health in General

Title III: General Provisions Respecting National Research

Institutes

Title IV: National Cancer Institute

Title V: National Heart, Lung, and Blood Institute

Title VI: National Institute on Diabetes and Digestive

and Kidney Diseases

Title VII: National Institute on Arthritis and

Musculoskeletal and Skin Diseases

Title VIII: National Institute on Aging

Title IX: National Institute of Allergy and Infectious

Diseases

Title X: National Institute of Child Health and Human

Development

Title XI: National Eye Institute

Title XII: National Institute of Neurological Disorders

and Stroke

Title XIII: National Institute of Environmental Health

Sciences

Title XIV: National Library of Medicine

Title XV: Other Agencies of National Institutes of Health

Title XVI: Awards and Training

Title XVII: National Foundation For Biomedical Research

Title XVIII: Research with Respect to Acquired Immune

Deficiency Syndrome

Title XIX: Studies

Title XX: Miscellaneous Provisions

Title XXI: Effective Dates

National Institutes of Health Revitalization Act of 1993 - Title I: General Provisions Regarding title IV of Public Health Service Act - (Sec. 101) Amends the Public Health Service Act to prohibit approving or funding of any proposal that is subject to human subject review and technical and scientific peer review unless the proposal has undergone the review and has been recommended for approval. Prohibits withholding funding on ethical grounds unless an ethics advisory board so recommends.

(Sec. 111) Authorizes and regulates research on human fetal tissue transplantation without regard to whether the tissue is obtained after a spontaneous or induced abortion or a stillbirth. Requires certain written statements by the donor, physician, researcher, and donee. Prohibits directed donations and alteration of the timing or procedures of abortions. Requires that abortion consent be obtained before requesting or obtaining donation consent. Requires research to be conducted in accordance with State law.

(Sec. 112) Imposes criminal penalties for: (1) transferring such tissue for valuable consideration affecting interstate commerce; or (2) soliciting or receiving a directed donation.

(Sec. 113) Prohibits any executive branch official from imposing a policy prohibiting the Department of Health and Human Services from conducting or supporting such research.

(Sec. 114) Mandates an audit and report by the General Accounting Office regarding whether and to what extent certain of these requirements have been violated.

(Sec. 121) Removes provisions regarding: (1) biomedical ethics; (2) waiver of a risk standard; and (3) the construction of title IV (National Research Institutes) of the Public Health Service Act. Declares ineffective an Executive Order relating to a fetal tissue bank and a Federal regulation relating to ethical advisory boards.

(Sec. 131) Requires: (1) inclusion of women and minorities as subjects in each clinical research project under title IV; and (2) related outreach. Makes the requirement of inclusion inapplicable if inclusion would be inappropriate with respect to the health of the subjects or the purpose of the research, but restricts considering the cost of inclusion.

(Sec. 141) Establishes: (1) the Office of Research on Women's Health; (2) the Coordinating Committee on Research on Women's Health; and (3) the Advisory Committee on Research on Women's Health.

Mandates: (1) study of the extent to which women are represented among senior physicians and scientists of the national research institutes (NRIs) and among those conducting supported research; and (2) as appropriate, activities to increase that representation.

Establishes: (1) a data system for the collection, analysis, and dissemination of information regarding research on women's health conducted or supported by NRIs; and (2) a program to provide information on research and prevention activities of NRIs relating to research on women's health.

Mandates: (1) a biennial report on research on women's health, including on the professional status of women physicians and scientists of NRIs; and (2) sufficient allocation of National Institutes of Health (NIH) resources for projects of women's health research.

(Sec. 551) Establishes the Office of Research on Minority Health.

(Sec. 161) Establishes the Office of Research Integrity as an independent entity in the Department of Health and Human Services. Requires grant, contract, or cooperative agreement applicants to have a process to review and report allegations of research misconduct. Establishes the Commission on Research Integrity. Provides for employee whistle blower protection. Mandates regulations defining financial conflicts of interest in a project of clinical research: (1) to evaluate the safety or effectiveness of a drug, medical device, or treatment; and (2) receiving financial assistance from the Secretary of Health and Human Services. Requires assistance applicants to: (1) have an administrative process to identify existing financial interest; and (2) report the interests and how the interests will be managed or eliminated. Requires, when the applicant fails to comply: (1) disclosure of the interest in each public presentation of project results; and (2) other actions as the Secretary determines appropriate.

Title II: National Institutes of Health in General - (Sec. 201) Modifies the duties of NIH's Associate Director for Prevention.

(Sec. 202) Establishes programs to: (1) enhance competitiveness in States receiving little funding from NRIs for conducting biomedical and behavioral research; and (2) support projects whose principal researchers have not previously served as principal researchers of such research.

(Sec. 203) Establishes the Office of Behavioral and Social Sciences Research. Requires the Office to coordinate NIH-conducted or NIH-supported research on the relationship between human behavior and medical conditions, including teen pregnancy, infant mortality, violent behavior, suicide, and homelessness.

(Sec. 204) Mandates activities, consistent with the global Children's Vaccine Initiative, to develop affordable new and improved vaccines for use in the United States and the developing world. Authorizes appropriations.

(Sec. 205) Requires preparation and implementation of a plan regarding the use of animals in research. Establishes the Interagency Coordinating Committee on the Use of Animals in Research. Repeals similar provisions.

(Sec. 206) Authorizes activities to increase the number of women and individuals from disadvantaged backgrounds (including racial and ethnic minorities) in biomedical and behavioral research.

(Sec. 207) Prohibits surveys of human sexual behavior conducted or supported through NIH unless the surveys have undergone specified review and the Secretary finds that they will assist in reducing infectious disease or in improving health conditions.

(Sec. 208) Establishes a fund for use by the NIH Director to carry out NIH activities. Authorizes appropriations.

(Sec. 209) Establishes the Office of Alternative Medicine to evaluate alternative medicine treatment modalities, including acupuncture and Oriental medicine, homeopathic medicine, and physical manipulation therapies. Establishes an advisory council. Requires the Office to establish an information clearinghouse and support research training.

(Sec. 210) Modifies NRI advisory council terms of office.

Requires that all new or revised NIH health education materials intended for the public not exceed functional literacy.

Authorizes a day care service for NIH employees.

Title III: General Provisions Respecting National Research Institutes - (Sec. 301) Requires that the Secretary of Health and Human Services receive directly all funds appropriated for each NRI, subject to provisions of title XVIII of this Act. Removes provisions authorizing the National Cancer Institute to directly receive such funds.

Modifies requirements regarding the establishment of technical and scientific peer review groups.

(Sec. 302) Requires expansion of research on osteoporosis, Paget's disease, and related bone disorders. Mandates a grant, cooperative agreement, or contract to establish a clearinghouse. Authorizes appropriations.

(Sec. 303) Establishes a comprehensive program of basic and clinical trauma research. Mandates a program plan and authorizes program grants. Establishes the Trauma Research Interagency Coordinating Committee.

Title IV: National Cancer Institute - (Sec. 401) Requires conducting and supporting (and, in some cases, expanding) National Cancer Institute (NCI) activities on breast and ovarian cancer, other cancers of the reproductive system of women, and prostate cancer. Mandates operation of research and demonstration centers. Authorizes appropriations. Removes authorizations of appropriations for NCI and the National Heart, Lung, and Blood Institute (NHLBI).

Title V: National Heart, Lung, and Blood Institute - (Sec. 501) Requires NHLBI to conduct intramural training and education.

(Sec. 502) Authorizes centers on cardiovascular diseases in children.

(Sec. 503) Establishes the National Center on Sleep Disorders and the Sleep Disorders Research Advisory Board. Mandates a comprehensive plan for the conduct and support of sleep disorders research.

(Sec. 504) Authorizes appropriations for NHLBI.

(Sec. 505) Requires the Director of NHLBI to conduct and support (currently, establish) programs for the prevention and control (currently, diagnosis, prevention, and treatment) of heart, blood vessel, lung, and blood diseases, including community-based and population-based programs carried out in cooperation with other entities. (Current law contains no such inclusions.)

Title VI: National Institute on Diabetes and Digestive and Kidney Diseases - (Sec. 601) Establishes a program of conducting and supporting research, training, health information dissemination, and other activities on nutritional disorders, including obesity. Mandates, subject to appropriations, the development or expansion of research and training centers.

Title VII: National Institute on Arthritis and Musculoskeletal and Skin Diseases - (Sec. 701) Establishes a children's arthritis and musculoskeletal disease center.

Renames the National Arthritis Advisory Board as the National Arthritis and Musculoskeletal and Skin Diseases Advisory Board and modifies its composition.

Title VIII: National Institute on Aging - (Sec. 802) Mandates research into the aging processes of women. Authorizes appropriations for the National Institute on Aging.

Title IX: National Institute of Allergy and Infectious Diseases - (Sec. 901) Includes tropical diseases in the purposes of the National Institute of Allergy and Infectious Diseases.

(Sec. 902) Authorizes grants or contracts for basic and clinical research on chronic fatigue syndrome. Establishes an extramural study section.

Title X: National Institute of Child Health and Human Development - (Sec. 1001) Mandates grants or contracts for centers on contraception and centers on infertility. Authorizes appropriations.

(Sec. 1002) Establishes a program of agreements with health professionals to conduct research on contraception or infertility in return for educational loan repayment.

(Sec. 1011) Establishes an obstetrics and gynecology intramural laboratory and clinical research program.

(Sec. 1021) Mandates development and support of child health research centers.

(Sec. 1031) Mandates a longitudinal, large-scale study on the general health and well-being of U.S. adolescents.

Title XI: National Eye Institute - (Sec. 1101) Authorizes grants to Diabetes Eye Research Institutions for programs in clinical or health services aimed at care services, basic and clinical research, and translating the latest research into clinical practice.

Title XII: National Institute of Neurological Disorders and Stroke - (Sec. 1201) Mandates research on multiple sclerosis.

Title XIII: National Institute of Environmental Health Sciences - (Sec. 1301) Establishes the Applied Toxicological Research and Testing Program.

Title XIV: National Library of Medicine - (Sec. 1401) Increases the limit on grants to medical libraries and related instrumentalities.

(Sec. 1402) Authorizes appropriations for the National Library of Medicine.

(Sec. 1411) Mandates grants for new educational technologies research.

(Sec. 1421) Establishes the National Information Center on Health Services Research and Health Care Technology to collect, analyze, and disseminate information on health services research, clinical practice guidelines, and health care technology.

Title XV: Other Agencies of National Institutes of Health - (Sec. 1502) Authorizes grants to alter or construct research facilities. Establishes the Scientific and Technical Review Board on Biomedical and Behavioral Research Facilities. Authorizes appropriations. Reserve funds to construct or improve regional centers for research on primates.

(Sec.1511) Redesignates the National Center for Nursing Research as the National Institute for Nursing Research (NINR). Adds NINR to the list of the national research institutes of NIH.

(Sec. 1512) Mandates a study on whether and to what extent there is a need for more nurses in hospitals and nursing homes.

(Sec. 1521) Makes the National Center for Human Genome Research an NIH agency. Includes in Center purposes the mapping and sequencing of individual genes and the reviewing and funding of proposals to address the ethical and legal issues associated with the genome project. Authorizes the conducting and support of research training.

Title XVI: Awards and Training - (Sec. 1601) Provides for recruitment of women and individuals from disadvantaged backgrounds into fields of biomedical or behavioral research and for research training for women and such individuals.

(Sec. 1602) Modifies the service requirements applicable to recipients of National Research Service Awards for research training.

(Sec. 1611) Mandates a program of Government repayment of health professionals' educational loans in return for the professionals, as NIH employees, conducting research regarding acquired immune deficiency syndrome. Authorizes appropriations.

(Sec. 1621) Mandates a program of Government repayment of health professionals' educational loans in return for the professionals, as NIH employees, conducting general research. Limits the program to professionals who have a substantial amount of loans relative to income.

(Sec. 1631) Authorizes, for individuals from disadvantaged backgrounds, programs of: (1) undergraduate scholarships in return for service as NIH employees; and (2) loan repayments in return for conducting clinical research as NIH employees.

(Sec. 1641) Authorizes appropriations related to National Research Service Awards, modifying set-aside requirements.

Title XVII: National Foundation for Biomedical Research - (Sec. 1701) Removes provisions setting forth the duties of the National Foundation for Biomedical Research. Declares that the Foundation's purpose is to support NIH in its mission and to advance collaboration with biomedical researchers. Authorizes certain Foundation activities.

Mandates the convening, by a specified date, of a meeting to incorporate the Foundation, establish its general policies, and appoint its Board. Modifies other requirements regarding: (1) the Foundation; (2) its Board, bylaws, and powers; (3) integrity and conflicts of interest; (4) intellectual property rights; and (5) the duties of its Director. Authorizes appropriations.

Title XVIII: Research with Respect to Acquired Immune Deficiency Syndrome - (Sec. 1801) Establishes the Office of AIDS Research, a related Advisory Council, and coordinating committees. Requires, that the Office's Director act as the primary Federal official with responsibility for overseeing all AIDS research conducted or supported by NIH. Mandates a comprehensive plan for the conduct and support of all AIDS activities of NIH agencies. Requires that a full-funding budget for carrying out the plan be submitted directly to the President and alternative budgets be submitted to the Secretary and the NIH Director. Authorizes appropriations to carry out the plan. Requires that the Office's Director receive directly from the President and the Office of Management and Budget all funds available for NIH AIDS activities. Centers AIDS research responsibility on the Office's Director (currently, on the Secretary, acting through the NIH Director).

(Sec. 1802) Establishes a fund for conducting or supporting AIDS activities as authorized in this Act for NIH but not provided for in any appropriations Act passed by the House of Representatives. Regulates fund use. Authorizes appropriations.

(Sec. 1811) Modifies the duties of: (1) the AIDS Clinical Research Review Committee; and (2) the acquired immune deficiency syndrome (AIDS) clinical evaluation units at the National Cancer Institute and National Institute of Allergy and Infectious Diseases.

Modifies international AIDS efforts support requirements. Authorizes appropriations for each fiscal year.

Requires that model protocols for the clinical AIDS care include treatment and prevention for women. Authorizes appropriations.

Requires the AIDS epidemiological data base to include information on the natural history of AIDS infection. Authorizes appropriations for each fiscal year.

Authorizes appropriations for each fiscal year for fellowship and training programs relating to AIDS.

Title XIX: Studies - (Sec. 1901) Mandates studies regarding third-party payment for health services incident to participation as subjects in clinical trials conducted in the development of drugs with respect to AIDS, cancer, and other life threatening illnesses.

Requires a plan for the inclusion in NIH human immunodeficiency virus (HIV) vaccine studies of women, infants, and children infected with HIV. Authorizes appropriations.

(Sec. 1902) Requires studies on malnutrition and the elderly, including regarding: (1) whether Federally subsidized home or institutional care is reduced because of increased independence resulting from improved nutrition; (2) whether reimbursement for nutrition screening and intervention is a cost-effective approach to improving the health status of elderly individuals; and (3) the extent of malnutrition in elderly individuals in hospitals and long-term care facilities and in elderly individuals living independently. Establishes an advisory panel.

(Sec. 1903) Mandates reports or studies on: (1) NIH research on chronic fatigue syndrome; (2) the appropriateness and impact of NIH assuming responsibility for the conduct of all Federal research, development, testing, and evaluation relating to medical countermeasures against biowarfare agents, including the impact under the Budget Enforcement Act and the Omnibus Budget Reconciliation Act of 1990 on existing NIH research programs as well as other domestic discretionary spending programs; (3) NIH support staff retention, recruitment, vacancy, and turnover rates; (4) a streamlined NIH procurement system; (5) the incidence of chronic pain and the effect of such pain on U.S. health care costs; and (6) whether there is a relationship between an individual's receptivity to use legal drugs and the consumption or abuse by the individual of illegal drugs.

(Sec. 1909) Authorizes the Secretary to fund research to develop a text-based standardized billing process and to determine whether the process can reduce administrative billing costs.

(Sec. 1910) Mandates a pilot sentinel disease surveillance system and, as appropriate, a follow-up system.

(Sec. 1911) Requires studies: (1) on environmental and other potential risk factors contributing to the incidence of breast cancer in specified counties in New York State and two other northeastern U.S. counties listed in a specified report; (2) on whether public and private funding for bioengineering is sufficient, the role of Federal agencies in achieving a greater commitment to bioengineering innovation, and the need for better coordination and collaboration; and (3) to estimate the average amount of health care expenditures incurred during the last six months of life by individuals 65 years old and older and by the total population. Requires that the National Medical Expenditure Survey for a specified year be designed to produce such an estimate.

Title XX: Miscellaneous Provisions - (Sec. 2001) Redesignates the Senior Biomedical Research Service as the Silvio O. Conte Senior Biomedical Research Service and increases the limit on the number of its members.

(Sec. 2002) Mandates a master plan to replace or refurbish NIH infrastructure.

(Sec. 2003) Authorizes appropriations (currently, authorizes the use of funds) to carry out cancer registries provisions.

(Sec. 2004) Prohibits the expenditure by an entity of funds appropriated under this Act for specified fiscal years unless the entity agrees to comply with the Buy American Act. Declares that it is the sense of the Congress that entities receiving financial assistance under this Act for certain fiscal years should, in spending the assistance, purchase only American-made equipment and products.

(Sec. 2005) Prohibits Project Aries (administered by the University of Washington at Seattle) from receiving, after a specified date, any funding (other than payments under prior awards) from any NIH agency unless certain requirements are met.

(Sec. 2006) Amends the Federal Food, Drug, and Cosmetic Act to mandate a program of educational loan repayments in return for health professionals conducting research as Food and Drug Administration employees. Authorizes appropriations.

(Sec. 2007) Amends the Immigration and Nationality Act to include infection with the etiologic agent for AIDS in the grounds for exclusion of aliens from admission to the United States.

(Sec. 2008) Amends the Public Health Service Act to allow (currently, require) the Director of the National Institute on Drug Abuse to ensure that all channels for the dissemination and exchange of scientific knowledge are maintained between the Administration and the other scientific, medical, and biomedical disciplines and organizations, nationally and internationally.

Grants limited authority for contracts with for profit entities for preventive health measures regarding breast and cervical cancers.

Renames the AIDS Clinical Research Review Committee as the AIDS Research Advisory Committee.

Requires that the Public Health Service (PHS) be administered by the Assistant Secretary for Health (currently, by the Surgeon General).

Authorizes the Secretary (currently, the Surgeon General) to organize the PHS. Adds the Agency for Health Care Policy and Research to the list of constituent part of the PHS.

(Sec. 2009) Requires a biennial (currently, an annual) report on carcinogens.

(Sec. 2011) Amends the Low-Income Home Energy Assistance Act of 1981 to authorize appropriations to carry out the Act.

(Sec. 2012) Amends the Public Health Service Act to authorize the United States Court of Federal Claims to continue to receive and forward petitions for compensation for a vaccine-related injury or death after a specified date.

(Sec. 2013) Requires the Administrator of the Agency for Health Care Policy and Research to make recommendations on whether specific health care technologies should be reimbursable under federally financed health programs.

(Sec. 2014) Amends provisions relating to insured health education assistance loans to graduate students to modify: (1) the actions an institution or post-graduate training program is authorized to take to assist in collection of a delinquent loan; and (2) conditions for discharge in bankruptcy.

Amends provisions relating to certain federally-supported student loan funds for schools of medicine, osteopathic medicine, dentistry, pharmacy, podiatric medicine, optometry, or veterinary medicine to change: (1) the limit on the amount of a loan, as applied to certain medical students; (2) allow waiver of repayment in specified circumstances; and (3) requirements regarding the percentage of graduates in primary care training or practice. Authorizes appropriations for Federal capital contributions to such funds for schools of medicine or osteopathic medicine, allowing the contribution only if certain primary care percentage requirements are met.

Adds maternal and child health to the list of fields with a severe shortage of health professionals for purposes of grants for graduate or specified training in public health.

Allows grants for traineeships for advanced education of professional nurses to be used for traineeships for participation in certificate nurse midwifery programs conforming to specified guidelines.

Changes which nurse education provisions are subject to certain peer review requirements.

(Sec. 2015) Prohibits the Secretary from conducting or supporting the SHARP survey of adult sexual behavior or the American Teenage Study of adolescent sexual behavior.

(Sec. 2016) Excludes research on the efficacy of services to prevent, diagnose, or treat medical conditions from the definition of "health services research" for purposes of provisions of the Public Health Service Act relating to the NRIs. Decreases health services research set-aside requirements regarding the National Institute on Alcohol Abuse and Alcoholism, the National Institute on Drug Abuse, and the National Institute of Mental Health. Extends the due date for an annual report on the activities carried out with funds made available for health services research relating to alcohol abuse and alcoholism, drug abuse, and mental health.

(Sec. 2017) Modifies requirements regarding set-asides for technical assistance with regard to comprehensive mental health services to children with a serious emotional disturbance.

(Sec. 2018) Allows amounts appropriated under the Department of Health and Human Services Appropriations Act, 1993 for buildings and facilities of NIH to be expended for repairing, improving, or constructing roads on non-Federal property in close proximity to the main NIH campus in the State of Maryland.

Title XXI: Effective Date - (Sec. 2101) Sets forth the effective date of this Act and its amendments.