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Office of |
The Assistant Secretary for Planning and Evaluation |
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Office of Program Systems |
BIOMEDICAL RESEARCH AMENDMENTS below; or to go to freestanding section, Click Here.
DISEASE PREVENTION AND CONTROL AMENDMENTS below; for freestanding section, Click Here.
FOOD AND DRUG IMPROVEMENT AMENDMENTS below; for freestanding, Click Here.
NATIONAL VACCINE INJURY COMPENSATION PROGRAM; for freestanding, Click Here.
PUBLIC HEALTH SERVICE AND RESOURCE AMENDMENTS; for freestanding, Click Here.
NIH-1997/01
NATIONAL INSTITUTES OF HEALTH
FISCAL YEAR 2001 DHHS
LEGISLATIVE PROPOSAL
Alcohol Abuse and Alcoholism Research
Extend Authorities for Research on Alcohol Abuse and Alcoholism.
Current Law: The Secretary, acting through the National Institute on Alcohol Abuse and Alcoholism, is authorized to conduct and support biomedical and behavioral research, health services research, research training, and health information dissemination with respect to the prevention of alcohol abuse and the treatment of alcoholism, under section 464H (42 USC 285n) of the PHS Act. The existing appropriation authority expires on September 30, 1994. The Institute is authorized for fiscal year 1995 through P.L. 103-333. A one-year authorization for FY 1996 is currently being drafted and we expect its approval. Public Law 103-333 and the passage of the draft bill will place NIAAA's reauthorization process parallel to the other NIH institutes.
Proposal: Extend authorization for appropriations for the research programs of the National Institute on Alcohol Abuse and Alcoholism for five years.
Rationale: The National Institute on Alcohol Abuse and Alcoholism (NIAAA) serves as the focus for the Federal government's efforts to reduce the medical, social and economic consequences of alcohol abuse and alcoholism within the United States. It is estimated that 10 percent of adult Americans are either alcoholic or have serious alcohol-related problems. Alcohol abuse is a major cause of diseases of the liver and pancreas; is a direct contributor to many other diseases including several types of cancer, hypertension, heart disease, and neurological disorders; and plays a significant role in preventable birth defects, retardation and learning disabilities as well as in injuries, homicides, and suicides. It is conservatively estimated that 25-30% of all urban hospital beds are filled due to the medical consequences of alcohol abuse. A minimum of 3 out of 100 deaths in the United States can be attributed to alcohol- related causes.
Expansion of scientific knowledge of the causes, prevention, treatment and consequences of alcohol abuse and alcoholism has enormous potential for reducing illness and death and for improving the quality of life for millions of Americans. Research advances in understanding the nature of alcoholism and improving the methods of prevention and treatment are already being integrated into the Nation's health care system. Future research initiatives will play a critical part in meeting the public health challenges of alcohol abuse and alcoholism.
Effect on Beneficiaries: This proposal will promote public health by continuing to facilitate NIAAA research which has enormous potential for improving the medical, social and economic consequences of alcohol abuse, and, therefore, the quality of life for millions of Americans.
Cost: Such sums as necessary for the next five fiscal years.
Personnel Requirements: None.
Effective Date: Upon enactment.
NIH-1997/02
6/14/99
NATIONAL INSTITUTES OF HEALTH
FISCAL YEAR 2001 DHHS
LEGISLATIVE PROPOSAL
Reauthorize the National Institute on Aging
Extend Authorization of Appropriations of the National Institute on Aging (NIA)
Current Law: Section 445I of the PHS Act, as amended by section 803 of P.L. 103-43, authorizes appropriations for fiscal years 1994 through 1996 for the NIA.
Proposal: Authorize appropriations for NIA research and training programs for five years.
Rationale: Population aging will become one of the most important social phenomena of the next half century, especially when the now middle-aged baby-boom generation becomes eligible for Social Security and Medicare. How this Nation and its institutions accommodate themselves to the dramatic demographic age shift will have a significant effect on the quality of life for all Americans in the 21st century.
Over the last 20 years, the National Institute on Aging has built a firm foundation to understand the usual changes with age as well as age-associated disorders, such as Alzheimer's disease, cardiovascular disease, osteoporosis, and cancer. Studies including the Institute's 41-year old Baltimore Longitudinal Study of Aging (BLSA) have shattered stereotypes about aging processes. These, and other studies have shown that productivity and creativity can increase with age; exercise, proper nutrition, and health screening and treatment strategies can reduce disability rates. As a result, fewer people now equate aging with inevitable decline and disease, and people of all ages are taking greater responsibility for their health. As the pace of discovery quickens, the potential of research to stave off disease and disability as well as promote independence and quality of life, improve health and health services, and enhance social supports is gaining momentum.
NIA-supported research has made major inroads in understanding the basis of aging and age- related diseases. For example, Alzheimer's disease (AD) has now been linked to alterations in specific proteins and has been shown to affect specific regions of the brain. Clinical trials of interventions to delay or prevent AD are now being initiated.
Basic research on cellular aging has applications that cross a wide range of health issues. For example, important links have been established between the mechanisms of cell cycle regulation, cell aging, and the uncontrolled proliferation of cancer cells. Research in this area can identify specific potential targets for new cancer drugs.
Investigations on vascular diseases, such as atherosclerosis are providing new directions for the development of interventions. Another major initiative is under way to develop the basis for new therapeutic approaches to adult late-onset diabetes.
Although the NIA has made significant progress, many challenges remain. Alzheimer's disease will reach critical proportions in the United States and other countries as the baby-boom generation ages. Consequently, the Nation is faced with a growing public health crisis unless interventions can be developed to halt or slow the progression of this disease.
Even with the hope of major advances in the treatment and prevention of such debilitating diseases, the demand for long-term care is expected to expand. Research holds the best hope to mitigate the need for long-term care or institutionalization, enhance the quality and efficiency of such care, ease the burden of long-term care, and forecast the requirements for long-term care.
Continued efforts in all areas of aging-related research are essential to promote independence and improve the quality of life for older Americans.
Effect on Beneficiaries: The American people, the health professions, and the biomedical research community would all be favorably affected.
Federalism Impact: This proposal does not directly regulate States or interfere with or displace essential State functions. It does not attach conditions to grants that are not related to the purpose of the grant or preempt State Law as discussed in E.O. 12612.
Cost: There is no intrinsic cost. Ultimate costs and benefits are contingent upon the appropriations process.
Effective Date: First day of FY 2000 fiscal year or upon enactment, whichever comes later.
NIH-1997/04
NATIONAL INSTITUTES OF HEALTH
FISCAL YEAR 2001 DHHS
LEGISLATIVE PROPOSAL
NCI General Cancer Research Authorization
Extend the Authorization for Appropriations for the National Cancer Institute (NCI) for the Next Five Fiscal Years
Current Law: Section 417 B(a) of the Public Health Service Act authorizes appropriations (other than that of its programs under section 412) for the NCI through Fiscal Year 1996. Section 417 B(d) authorizes appropriations for cancer control programs conducted under Section 412. Additional authorizations for breast/gynecological cancers and prostate cancer are found under Section 417 B(b) and (c).
Proposal: Authorize appropriations for all cancer research activities for five years.
Rationale: The NCI is the Federal government’s lead agency for cancer research. Established in 1937, the mission of the Institute is the conduct and support of research, training, health information dissemination, and other programs with respect to the cause, diagnosis, prevention and treatment of cancer, rehabilitation from cancer, and the continuing care of cancer patients and their families. The NCI is responsible for leading the National Cancer Program (NCP), which consists of an expanded, intensified and coordinated cancer research program encompassing the research programs conducted and supported by the Institute and the related research programs of other public and private sector organizations, including an expanded and intensified research program for the prevention of cancer caused by occupational or environmental exposure to carcinogens.
The NCI supports research on all aspects of the cancer process, from molecular biology to prevention, diagnosis, causation, control, and treatment. Over the past several years, NCI- supported basic research has led to an unparalleled understanding of the cancer cell. During this time, scientists have discovered that all cancers are genetic diseases. This knowledge, and a continued investment in cancer research, will ultimately allow us to prevent, diagnose, and successfully treat these diseases.
The continuation of NCI’s research program is essential to America’s commitment to further progress against cancer.
The NCI has statutory authority, through the professional judgement or ByPass Budget (Section 413(b)(9) of the Act), to alert the President directly to future cancer research opportunities and their related estimated costs. This narrative serves as a forum to express the NCI’s professional judgement of scientific needs that must be addressed to achieve the eradication of this disease. The ByPass Budget is widely distributed upon request to Congress, research organizations, advocacy groups, and the general public. In order to allow maximum flexibility in addressing emerging areas of scientific research and investment opportunities, we recommend that the authorization of appropriations for the NCI be, such sums as necessary for the full reauthorization period.
Companion legislative proposals have been submitted to delete the separate authorization of appropriations for breast/gynecological cancers, prostate cancer, and cancer control. This proposal would therefore include all activities authorized under PHS Act for cancer research under a single authorization of appropriations.
Effect on Beneficiaries: The beneficiaries of the National Cancer Program are all citizens for whom cancer is prevented and all the cancer patients and their families both in this country and throughout the world. The benefits of NCI-supported research also extend to the pharmaceutical industry, biotechnology, and the scientific research community where untargeted basic research by NCI has already led to tremendous advances.
Cost: Such sums as necessary for the next five fiscal years.
Personnel Requirements: Negligible.
Effective Date: Upon enactment.
NIH-1997/07
6/14/99
NATIONAL INSTITUTES OF HEALTH
FISCAL YEAR 2001 DHHS
LEGISLATIVE PROPOSAL
NIDA Appropriations
Extend Authorization of Appropriations for the National Institute on Drug Abuse
Current Law: Title IV, Sections 464L(d)(1) and 464P(e) of the Public Health Services Act currently authorizes appropriations for the National Institute on Drug Abuse. NIDA conducts and supports biomedical and behavioral research, health services research, research training, and health information dissemination with respect to the prevention of drug abuse and treatment of drug abusers.
Proposal: Extend the authorization for appropriations for such programs at such sums as necessary for five years.
Rationale: Extension of authorization of appropriations for the National Institute on Drug Abuse will ensure continuation of timely research in the areas of drug addiction and recovery.
Effect on Beneficiaries: This proposal will contribute to the public health by ensuring the continuation of research on drug abuse and addiction and the treatment of drug abusers as well as improving the medical, social and economic consequences of drug abuse.
Cost: 464L(d) and 464P(e): Such sums as necessary for each of the five fiscal years.
NIH-1997/08
NATIONAL INSTITUTES OF HEALTH
FISCAL YEAR 2001 DHHS
LEGISLATIVE PROPOSAL
Superfund Research and Training Grants
Extend the Dollar Authorization for the National Institute on Environmental and Health Sciences University-based, Basic Research and Training Grants Program in Support of the Comprehensive Environmental Response, Compensation, and Liability Act
Current Law: Section 311 on Research, Development, and Demonstration of the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA, also known as the Superfund law) was added by section 209 of P.L. 99-499, the Superfund Amendments and Reauthorization Act of 1986. The dollar authorization for section 311 activities is contained in sections 111( c ) (10) and (n) of the CERCLA. CERCLA section 311(a) established a new program of basic research and training, managed by the National Institute of Environmental Health Sciences (NIEHS), to fill the gaps in the scientific information regarding health and environmental effects from the release of hazardous substances into the environment. Studies conducted under the program are to: (1) develop methods and technologies to detect hazardous substances in the environment; (2) advance techniques for the detection, assessment, and evaluation of the effects on human health of hazardous substances; (3) develop methods to assess the risk to human health presented by hazardous substances; and (4) develop basic biological, chemical, and physical methods to reduce the amount and toxicity of hazardous substances. Sections 111 and 311 of the CERCLA permit NIEHS to use up to ten percent of funds to train scientists and other professionals necessary to protect human health and the environment from the harmful affects of the transportation, storage, and permanent disposal of hazardous substances.
Proposal: Extend the funding authorization contained in section 111(c)(10) and section 111(n)(2) of the CERCLA through Fiscal Year 2003. Such an extension would provide support for the NIEHS basic research and training program at a level that would enhance significantly the scientific and technical base for the cleanup program, and provide for the training of scientists and other professionals required for decisions made by the Environmental Protection Agency (EPA), the Department of Energy (DOE), and the Department of Defense (DOD) in the management of hazardous substances at abandoned waste sites.
Rationale: The NIEHS Superfund basic research and training grants program provides environmental technologies for commercial markets and scientific knowledge needed by Superfund administrators and program officials so they can fulfill their responsibilities regarding safe disposal of toxic wastes and emergency response to accidental release of hazardous substances.
The Superfund law requires that EPA assess each site proposed for remediation and “select a remedial action that is protective of human health and the environment, that is cost-effective, and that utilizes permanent solutions…to the extent practicable.” Site prioritization must be based on sound information regarding the risks that the site presents before remediation. Selection of the most cost-effective cleanup option can only be made if there are good data to support reduction of environmental contamination to levels that are permanently protective. Cleanup activities have been completed at more than 340 sites with over 1,300 remaining on the National Priorities List and more than 5000 waiting for assessment.
The NIEHS Superfund basic research and training program’s primary goal is to provide a unique opportunity for the researchers from the biomedical sciences, engineering, ecology, and the geosciences to explore the scope of the problems of uncontrolled hazardous waste and seek solutions. No other agency provides support for this kind of multidisciplinary research effort. The Program is designed to provide a broader and more detailed body of scientific information to be used by state, local, and federal agencies and by private organizations and industry in making decisions related to the management of hazardous substances. To accomplish its goals and objectives, the NIEHS presently supports 17 grants at 69 institutions throughout the United States which encompass 134 individual research projects involving more than 1000 scientists. Continued support of these scientists in their collaborative efforts is crucial to protect those at risk from the health hazards of toxic waste sites.
The basic research and training program conducted by NIEHS’s grantees should be reauthorized so that it can continue to provide the scientific knowledge required by Superfund program managers to select the best remedial action and to evaluate the health and safety, and effectiveness of those decisions. Continued development in the area of technology transfer is especially critical in expediting the transfer of the Program’s basic research findings to applied research and ultimately to the demonstration and commercialization of this technology. In addition, this program provides most of the support for multidisciplinary training of scientists and other health professionals.
The FY98 proposed budget is based on H.R. 228, Superfund Reform Act of 1995, and would allow for the continued funding of the current 17 programs and for funding of additional grants to meet programmatically relevant scientific goals and objectives in a second competition. Out years reflect adjustments for inflation.
Lack of basic understanding of fundamental environmental processes and health affects will hinder effective, timely, and cost-effective remedial actions. Lack of adequate information about the effects of hazardous substances on human health will also hamper the ability to assess risks, issue appropriate standards, and task enforcement actions.
Effect on Beneficiaries: There are over 1,300 abandoned toxic chemical waste disposal sites on the National Priority List complied by the EPA. These sites contain hundreds of extremely hazardous compounds which contaminate the air, soil, food, and water around them. One in four Americans lives within four miles of an NPL site. Tens of thousands of people have been and will continue to be exposed to the contents of these sites unless effective remediation occurs. The EPA, with the cooperation of state and local government officials, private industries, and academic institutions have the responsibility for containing or destroying these substances and protecting the affected people and environments. The research studies to be conducted under the NIEHS program would improve and strengthen the environmental remedies and help protect the health and food/water supply of the persons living and working near the sites.
Cost: Such sums as necessary for the next five fiscal years.
Effective Date: Upon enactment.
NIH-1997/09
NATIONAL INSTITUTES OF HEALTH
FISCAL YEAR 2001 DHHS
LEGISLATIVE PROPOSAL
Superfund Worker Safety Training Grants Program
Extend the Dollar Authorization for the Program of Grants for the Training and Education of Workers Who are or May be Engaged in Activities Related to Hazardous Waste Removal or Containment or Engaged in Response to Emergencies Involving Releases of Hazardous Substances
Current Law: Section 126(g) of P.L. 99-499, the Superfund Amendments and Reauthorization Act of 1986 (SARA), establishes a worker training grants program to be administered by the National Institute of Environmental Health Sciences. [This is a stand alone provision in SARA and not an amendment to the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA) as is the other authority given to NIEHS under P.L. 99-499.] The purpose is to make grants for the training and education of workers and their first-line supervisors, as well as for training of emergency response personnel (e.g., fire fighters and police officers), in appropriate actions to protect themselves and bystanders from dangers of exposure to hazardous substances. Authorization for funding through FY 1994 for SARA section 126(g) grants is included in section 111(c)(12) of CERCLA at not to exceed $20 million for each fiscal year.
Proposal: Reauthorize, for five years, section 126(g) of the Superfund Amendments and Reauthorization Act of 1986 to continue support for grants to train workers, supervisors, and emergency response personnel engaged in hazardous waste management and emergency response by amending section 111(c)(12) of CERCLA.
Rationale: In the NIEHS program, not-for-profit organizations instruct workers and their supervisors and emergency response personnel on how to prevent harmful exposures to themselves and to the community to hazardous substances at abandoned waste sites, at licensed disposal sites, and at the scenes of potentially catastrophic releases of hazardous substances.
There are over 30,000 abandoned chemical waste sites known to exist in the U.S. Over 1,300 of these are considered by the EPA to present an unacceptable health and environmental threat; their contents must be immobilized, removed, or destroyed. Such operations require intensive manual labor and are extremely dangerous to site workers and their supervisors. There are approximately 5,000 active hazardous disposal sites currently in operation which pose risks to workers. Moreover, dozens of areas severely contaminated by low and high level radioactive wastes must be cleaned up. Each day, somewhere in the United States, an industrial facility experiences a fire or explosion or a train or truck crash releasing reactive, explosive, corrosive, or toxic substances. Among the first to appear at these incidents are fire fighters and police, who then are in peril of death or severe injury. These workers are the first line of defense against a public health catastrophe, but in carrying out their duties they are at greatest risk of harm if they are not trained to recognize and avoid actions which are dangerous.
Safe and permanent disposal or destruction of hazardous wastes continues to be a national priority. Special efforts are required to train and educate workers, particularly those engaged in federally mandated environmental programs. In 1989, the Department of Labor promulgated regulations for the protection of workers in hazardous waste management and emergency response operations as required in the 1986 reauthorization. These regulations are comprehensive, detailed, and require that 40 or more hours of training be given before workers are employed. The NIEHS grants for training site workers and emergency response personnel have set the standard for such training programs.
The DOL estimates at least 1.758 million persons are covered by federal regulations to protect hazardous waste management workers and emergency response personnel. Efforts over the past nine years by NIEHS have provided training to over 400,000 workers, supervisors, and emergency response personnel.
Support of this model training program should continue for so long as there is a need for workers to be engaged in the particularly dangerous professions of collecting and transporting hazardous waste materials; operating in the newly developed technologies related to hazardous waste disposal; and responding to emergencies involving toxic substances.
Effect on Beneficiaries: The effects and benefits from this program are clear. Site workers, supervisory staff, and emergency response personnel are protected through the prevention of acute injuries, acute and chronic illnesses, and adverse reproductive outcomes. The training contributes to employee morale and productivity by increasing professionalism and insuring a healthier work force. Societal benefits accrue from the training program through the reduction of time lost from occupational illness and injury and of costs to workers compensation programs for the treatment of exposure-related long-term illnesses and serious injuries.
Cost: Such sums as necessary for the next five fiscal years.
Effective Date: Upon enactment.
NIH-1997/10
NATIONAL INSTITUTES OF HEALTH
FISCAL YEAR 2001 DHHS
LEGISLATIVE PROPOSAL
Contraception and Infertility Research
Reauthorize appropriations for National Institute of Child Health and Human Development Research Centers with respect to contraception and infertility and eliminate the requirement limiting the number of centers.
Current Law: The National Institutes of Health Revitalization Act of 1993, P.L. 103-43, Title IV, section 452A(g) of the PHS Act [42 U.S.C. 285g-6] provided that “For the purpose of carrying out this section, there are authorized to be appropriated $30,000,000 for fiscal year 1994, and such sums as may be necessary for each of the fiscal years 1995 and 1996.” In addition, section 452A(b) of the PHS Act [42 U.S.C. 285g-5] states that “In carrying out subsection (a), the Director of the Institute shall, subject to the extent of amounts made available in appropriations Acts, provide for the establishment of three centers with respect to contraception and for two centers with respect to infertility.”
Proposal: Reauthorize appropriations for the National Institute of Child Health and Human Development Contraception and Infertility Research Centers for five years and delete statutory language which limits the number of such centers that may be funded.
Rationale: The statutory authorization of the NICHD Contraception and Infertility Research Centers enhanced the Institute’s initiative to expand and strengthen its activities in the areas of contraception and infertility research, as well as established the mandate of Congress to make research in these areas a high priority for the Institute. Statutory reauthorization of the NICHD Contraception and Infertility Research Centers for the next five fiscal years would renew the mandate of Congress and reenforce the Institute’s efforts in these areas of research. Repealing the words “three” and “two” in section 452A(b) would eliminate the requirement to establish three Contraception Research Centers and two Infertility Research Centers, which began as a “floor” but has become a “ceiling” limiting the possible expansion of these research centers programs.
Cost: Such sums as necessary for the next five fiscal years.
Personnel Requirements: There would be no additional personnel needed.
Effective Date: Upon enactment.
NIH-1997/11
NATIONAL INSTITUTES OF HEALTH
FISCAL YEAR 2001 DHHS
LEGISLATIVE PROPOSAL
Authorities of the NIH Director
Provide the Authorities of the National Research Institutes to the NIH Director So That They May Be Delegated to NIH Components as the NIH Director Deems Appropriate
Current Law: The PHS Act provides authorities to each national research institute but not to other NIH components (for example, CC, NCRR, FIC, NLM, OSE and CIT.) Many of these authorities have been made available to NIH components through other statutory provisions or delegation of authority from the NIH Director.
Proposal: Amend Section 402 of the PHS Act to provide the authorities of the national research institutes found in Section 405 of the PHS Act to the NIH Director, so that they may be delegated to other NIH components as the NIH Director deems appropriate.
Rationale: Certain authorities were provided for the Directors of “national research institutes” but not to the Directors of the Clinical Center, the National Center for Research Resources, Fogarty International Center, the National Library of Medicine, the NIH Office of Science Education, the Division of Computer Research and Technology, or other NIH components. Providing these legislative authorities to the NIH Director would enable the NIH Director to delegate these authorities to NIH components as the NIH Director deems appropriate. For example, authorities:
Cost: None.
Personnel Requirements: None.
Effective Date: Upon enactment.
NIH-1997/12
NATIONAL INSTITUTES OF HEALTH
FISCAL YEAR 2001 DHHS
LEGISLATIVE PROPOSAL
National Heart, Lung and Blood Institute
Extend Authorization of Appropriations of the National Heart, Lung, and Blood Institute.
Current Law: Section 425 of the PHS Act, as amended by section 504 of P.L. 103-43, authorizes appropriations for Fiscal Years 1994 through 1996 for the NHLBI.
Proposal: Authorize appropriations for NHLBI research activities and training and prevention and control programs for five years.
Rationale: The Institute's broad mandate addresses the needs of Americans for better health through increased understanding; more effective treatment; and earlier prevention of heart, blood vessel, lung, and blood diseases. Recently, sleep disorders also became part of the NHLBI mission. NHLBI research activities are complemented by the Institute's professional and public education programs including the National High Blood Pressure Education Program, National Cholesterol Education Program, National Asthma Education and Prevention Program, and National Heart Attack Alert Program.
The success of past investments illustrates the potential achievements of future research. For example, age-adjusted coronary heart disease death rates declined 53 percent between 1970 and 1993, and rates for stroke declined 60 percent. Infant mortality rates are now at a historic low, in large part because of improvements in our ability to treat and prevent respiratory distress syndrome, a common lung complication of prematurity. Life expectancy for people afflicted with inherited diseases, such as cystic fibrosis and sickle cell anemia, has soared as research has provided new skills to combat the devastating complications of these illnesses.
However, many challenges remain. Cardiovascular, lung, and blood diseases within the Institute's purview still account for 52 percent of all deaths in the United States. Further, although significant progress has been made in averting deaths, success has been accompanied by a large increase in the number of Americans who suffer from chronic diseases such as congestive heart failure and emphysema. These conditions seriously reduce the quality of life of affected individuals and can lead to significant expenditures for hospitalizations, physician visits, drugs, and other forms of health care. Continued research in these and related areas is essential to improving the health status of the American people.
Effect on Customers: The American people, the health professions, and the biomedical research community would all be favorably affected.
Impact on Partners: This proposal does not directly regulate States or interfere with or displace essential State functions. It does not attach conditions to grants that are not related to the purpose of the grant or preempt State Law as discussed in E.O. 12612.
Cost: Such sums as necessary
Effective Date: Upon enactment.
NIH-1997/13
NATIONAL INSTITUTES OF HEALTH
FISCAL YEAR 2001 DHHS
LEGISLATIVE PROPOSAL
National Library of Medicine
Reauthorize Appropriations for the National Library of Medicine
Current Law: Title IV, Part D of the Public Health Service Act provides authority for the National Library of Medicine (NLM) to assist the advancement of medical and related sciences and to aid the dissemination and exchange of scientific and other information. The existing appropriation authority expired on September 30, 1996.
Proposal: Reauthorize the appropriations authority for the National Library of Medicine for five years.
Rationale: Reauthorization of the National Library of Medicine programs will ensure the timely dissemination of scientific information, an integral part of the research process. Utilized primarily by health professionals, including clinicians, researchers, and educators, the biomedical and specialized toxicology information services available from the NLM are critical to the nation's health. The world's largest research library in a single scientific and professional field, the NLM acquires, organizes, and preserves materials in all major areas of the health sciences and serves as a national resource for all U.S. health science libraries. The Library conducts important research and development programs in biomedical communications designed to apply advanced computer and communications to medical information. Under the National Center for Biotechnology Information, the Library manages and distributes the rapidly growing body of information in the field of molecular biology, particularly genetic sequence information. The Library's extramural program provides a range of grants relating to the management, dissemination, and use of medical knowledge. Authorized since 1965 under the Medical Library Assistance Act, these grants seek to improve biomedical communication and knowledge access and continue to represent the only Federal programs focusing on information issues that concern the entire health community.
Effect on Beneficiaries: The NLM programs ensure that all who need medical information are able to access it. The Library's extensive collections, sophisticated information services, research and development programs, and grants are important to the public health.
Authorization Level: Such sums as may be necessary for the next five fiscal years.
NIH-1997/14
NATIONAL INSTITUTES OF HEALTH
FISCAL YEAR 2001 DHHS
LEGISLATIVE PROPOSAL
National Institute of Mental Health
Reauthorize the National Institute of Mental Health.
Current Law: Title IV, Section 464R(f)(1) of the Public Health Service Act currently authorizes appropriations for the National Institute of Mental Health (NIMH) at $675,000,000 for FY 93 and such sums as necessary for FY 94. The National Institute of Mental Health conducts and supports biomedical and behavioral research, health services research, research training and health information dissemination with respect to the cause, treatment, control and prevention of mental illness.
Proposal: Extend the authorization for appropriations for such programs for five years.
Rationale: Authorization for appropriations to the National Institute of Mental Health expired in FY 94. A five year reauthorization will place the NIMH on the same authorization cycle as the National Cancer Institute and the National Health, Lung and Blood Institute. There is a compelling need to continue to fund the programs of the NIMH. NIMH research has brought hope and relief to millions of people with mental disorders, their families and their friends. More than 5 million people suffer from such severe illnesses as schizophrenia, major depression, manic-depressive illness and obsessive-compulsive disorder.
Effect on Beneficiaries: Mental Illnesses cost the nation a staggering $148 billion in 1990 for direct and indirect costs. Improved treatments and services that result from NIMH research can greatly lower these costs to individuals and society.
Federalism Impact: This proposal does not directly regulate States nor interfere nor displace essential State functions; attach to grants conditions that are not related to the purpose of the grant or preempt State law.
Cost: Such sums as necessary for the next five fiscal years.
Personnel Requirements: No additional personnel required.
Effective Date: Upon enactment.
NIH-1997/15
5/18/00
NATIONAL INSTITUTES OF HEALTH
FISCAL YEAR 2001 DHHS
LEGISLATIVE PROPOSAL
Reauthorize Comprehensive Plan for AIDS Research
Reauthorize the Comprehensive Plan, Bypass Budget, and Consolidated Appropriations for the Office of AIDS Research
Current Law: Section 2353 of Public Law 103-43, the NIH Revitalization Act of 1993, stipulates that with respect to Fiscal Years 1994 through1996 the Director, OAR, shall establish a comprehensive plan for the conduct and support of all AIDS activities of the National Institutes of Health and assure that all amounts appropriated for such activities are expended in accordance with the Plan; shall prepare and submit directly to the President for review and transmittal to the Congress a budget estimate for carrying out the Plan for the fiscal year, after reasonable opportunity for comment (but without change) by the Secretary, the Director of the National Institutes of Health, and the advisory council established under section 2352; and shall receive directly from the President and the Director of the Office of Management and Budget all funds available for AIDS activities of the National Institutes of Health for distribution to the Institutes, Centers and Divisions according to the priorities of the comprehensive plan.
Proposal: Reauthorize Section 2353 of the PHS Act – with the exception of portions of Section 2353(c)(1)(A) that restrict the Department of Health and Human Services, OMB and the President, from the exercise of their normal budget responsibilities and authority – for five years to provide continuing direction and coordination of NIH AIDS research, as well as to chart a new course for the future.
Rationale: The NIH Revitalization Act restructured the way the NIH carries out AIDS research, investing primary responsibility for planning, coordinated and funding all AIDS-related research in the OAR. The planning and budget process developed by OAR, in response to the need for a more focused and targeted NIH AIDS program, symbolizes a turning point in the conduct of AIDS research. It provides the opportunity for the NIH to set in place refocused scientific priorities and to shift resources to meet these priorities. This inclusive process, involving representation from each of the NIH Institutes and Centers, nongovernment researchers, both in AIDS and other related disciplines, and community leaders in AIDS, results in formation of a consensus regarding the formulation and prioritization of the objectives that will guide research within each of the areas of research emphasis.
The Congress strongly believed that in order to meet the growing challenge that AIDS presents, a more focused and coordinated response from the NIH was necessary. The AIDS research effort is unlike any other research program of the NIH, in that every Institute and Center conducts or supports AIDS research. Furthermore, the management of this complex $1.3 billion portfolio requires a unique and unprecedented level of scientific oversight to ensure collaboration and minimize duplication in a united research front against the epidemic. Particularly at a time of budgetary constraints, effective management of this portfolio, to take advantage of the scientific opportunities, is more critical than ever. The authority provided by the single appropriation will allow the Director of OAR to effectively bring about the efficient redirection of research across all of the institutes by managing the research resources based on sound scientific judgment, without seriously damaging ongoing programs, and taking advantage of the most promising scientific avenues.
Effects on Customers: AIDS is now the leading cause of death among all Americans aged 25 to 44 years. These deaths are disproportionately disruptive to society, as this age group constitutes the majority of the civilian labor force. More than 440,000 cases of AIDS, including more than 6,000 among children, have been reported to the Centers for Disease Control since the epidemic was first recognized. More than 250,000 people in the U.S. have died from AIDS or AIDS-related causes. In the United States today, one person dies of AIDS every eight minutes. Approximately one million Americans are estimated to be HIV-infected. The epidemic has undergone striking demographic changes with more than half the new cases of AIDS occurring in women, children and adolescents, particularly among minority populations.
Worldwide, more than 985,000 cases of AIDS have been reported to the World Health Organization from more than 160 countries, and WHO estimates that 18 million adults and 1.5 million children have been infected since the late 1970s. WHO also estimates that by the year 2000, between 30 and 40 million people will become HIV-infected. The epidemic is now spreading faster in Asia than anywhere else in the world. Heterosexual transmission is the predominant mode of transmission worldwide. In the U.S., cases of heterosexually transmitted AIDS have increased 114 percent in adult and adolescent makes and 139 percent in adult and adolescent females from 1992 to 1993. There is an alarming increase in HIV infection among adolescents (aged 10 to 18 years), as demonstrated by the growing number of 20 to 20 year olds with AIDS who acquired HIV infection during adolescence.
These striking statistics indicate that there can be no lessening of our effort to master this disease. A well-planned and coordinated research response is critical to manage resources and capitalize on scientific opportunities to prevent, treat, and control this devastating pandemic.
Cost: Such sums as necessary for the next five fiscal years.
NIH-1997/17
NATIONAL INSTITUTES OF HEALTH
FISCAL YEAR 2001 DHHS
LEGISLATIVE PROPOSAL
National Research Service Awards
Reauthorize the National Research Service Award Programs.
Current Law: Section 487, Part G of the Public Health Service Act provides authority to the Secretary of the Department of Health and Human Services for National Research Service Awards (NRSA) programs which support predoctoral and postdoctoral training in biomedical, behavioral and clinical sciences. The existing appropriation authority expired September 30, 1996.
Proposal: Reauthorize the appropriations authority for five years.
Rationale: Under Section 487, the National Institutes of Health (NIH), the Agency for Health Care Policy and Research (AHCPR), and the Health Resources Services Administration (HRSA) make training grant and fellowship awards to support predoctoral and postdoctoral training. Training grants are awards to non-Federal public and non-profit private institutions of higher learning. Under a training grant, the principal investigator selects the graduate students and postdoctorates for appointment and support under this program. Section 487 also authorizes fellowship awards to individual graduate students and postdoctorates who are pursuing training in a health- related areas. Fellowships may be sponsored by Federal and non-Federal, for profit and non-profit research institutions.
Since the NRSA programs were first authorized in 1974, they have been evaluated on a periodic basis and modified to ensure that a well-trained cadre of scientists will continue to be available to solve the biomedical research questions of the future. Over the years, more than 130,000 individuals have received support for graduate or postdoctoral training under this program. At the current time, approximately 9 percent of all full-time graduate students in biomedical sciences receive support from NRSA. Career outcome studies have shown that recipients of NRSA support have longer and more productive scientific careers than graduate students and postdoctorates that received comparable training but without NRSA support. The quality of the programs is reflected in recommendations in the 1995 report from the Committee on Science, Engineering, and Public Policy of the National Academy of Sciences, Reshaping the Graduate Education of Scientists and Engineers. This Committee recommended that all Federal agencies should adopt the NRSA research training grant as a model for graduate research training support.
Effect on Beneficiaries: The NRSA programs provide stipend and tuition support for predoctoral and postdoctoral trainees and fellows in biomedical and behavioral research. These programs ensure that the training is relevant to the Nation’s needs for health-related research and is of the highest quality available.
Authorization Level: Such sums as necessary for the next five fiscal years.
NIH-1997/19
NATIONAL INSTITUTES OF HEALTH
FISCAL YEAR 2001 DHHS
LEGISLATIVE PROPOSAL
Director’s Discretionary Fund
Reauthorize the Discretionary Fund of the Director of the National Institutes of Health.
Current Law: Section 402 of the Public Health Service, as amended by section 206 of the National Institutes of Health Revitalization Act of 1993 (P.L. 103-43), establishes a fund for use by the Director of NIH to carry out the activities authorized for the National Institutes of Health.
Proposal: Reauthorize the Director of NIH’s discretionary fund for five years.
Rationale: Reauthorization of the fund will allow the Director, NIH to continue to provide for research on matters that have not received significant funding relative to other matters, respond to new issues and scientific emergencies, act on research opportunities of high priority and support research that is not exclusively within the authority of any single agency of the Institutes. The Director, NIH will continue to support high priority, cross-cutting scientific research.
Cost: Such sums as necessary for the next five fiscal years.
Effective Date: Upon enactment.
NIH-1997/30
NATIONAL INSTITUTES OF HEALTH
FISCAL YEAR 2001 DHHS
LEGISLATIVE PROPOSAL
Modernization and Construction of Research Facilities
Reauthorize the Modernization and Construction of Biomedical and Behavioral Research Facilities and Terminate the Board
Current Law: The Modernization and Construction of Facilities is authorized under Title IV, Part E, Subpart 1, Section 481A of the Public Health Service (PHS) Act. The existing appropriation authority expired on September 30, 1996. Section 481A(b) established the Scientific and Technical Review Board on Biomedical and Behavioral Research Facilities.
Proposal: Reauthorize the appropriation authority for the Modernization and Construction of Facilities under Section 481A of the PHS Act for five additional years.
Terminate the Scientific and Technical Review Board on Biomedical and Behavioral Research Facilities by deleting Section 481A(b).
Rationale: Reauthorization of the appropriations authority for the Modernization and Construction of Facilities would allow the Federal Government to continue to make grants to public and non-profit private entities to expand, remodel, renovate, or alter existing research facilities or construct new research facilities. Termination of the Board is recommended because the Board is performing functions more appropriately performed by the existing National Center for Research Resources (NCRR) initial review group and the National Advisory Research Resources Council. Using these two entities would also ensure continuity, experience, and uniformity of scientific peer review. In addition, termination of the Board is consistent with NIH streamlining efforts and Executive Order No. 12838, dated February 10, 1993, entitled “Termination and Limitation of Federal Advisory Committees.”
Cost: Such sums as necessary for the next five fiscal years.
Personnel Requirements: None.
NIH-1997/31
NATIONAL INSTITUTES OF HEALTH
FISCAL YEAR 2001 DHHS
LEGISLATIVE PROPOSAL
Regional Primate Research Centers Construction
Extend Authorization of Appropriations for the Construction of Regional Primate Research Centers
Current Law: Title IV, Part E, Subpart 1, Section 481B of the Public Health Service (PHS) Act provides authority for grants and contracts to be made to public and nonprofit private entities to construct, renovate, or otherwise improve such regional primate research centers. Section 481A(h) authorizes the appropriations for this construction. The existing appropriation authority expired on September 30, 1996 (NIH-1997/30 extends authorization of appropriations for 481A(h)).
Proposal: Reauthorize the appropriation authority for the Regional Primate Research Centers, Section 481B of the PHS Act, for five years.
Rationale: Reauthorization of the appropriations authority for the Regional Primate Research Centers would allow the Federal Government to continue to make awards of grants and contracts to public and nonprofit entities to construct, renovate, or otherwise improve such regional primate research centers.
Effect on Beneficiaries: The number of research facilities benefitting from this proposal depends on existing funding levels.
Federalism Impact: None
Cost: Such sums as necessary for each of the five fiscal years.
Personnel Requirements: None
Effective Date: Upon enactment.
NIH-1997/33
NATIONAL INSTITUTES OF HEALTH
FISCAL YEAR 2001 DHHS
LEGISLATIVE PROPOSAL
Definition of Construction
Correct Cross-Reference Related to Construction Definition in Centers Authority To Restore an Inadvertently Eliminated Definition for Construction.
Current Law: NIAAA's alcohol research centers authority [Sec. 464J(b)] contains language that declares that "No funds provided under a grant . . . may be used for the . . . construction . . . of any building." By referring to another section of law [Sec. 701(1)], NIAAA's authorizing language should provide a definition of construction. Unfortunately, the referenced section of law was eliminated during work on another bill. Current NIAAA law states, in PHS Act Sec. 464J(b) that "the term "construction" has the meaning given by section 701(1)."
Section 701(1) no longer exists; thus, the PHS Act sentence above is obsolete and is footnoted in the most recent Compilation of Health Law to indicate that, concurrent to the passage of P.L. 102-321, Congress was passing another law, P.L. 102-408, which eliminated the definition of construction now in former section 701(1).
Proposal: Place into NIAAA's current authorizing language [464J(b)] the long-used definition of construction that appeared, prior to elimination, in PHS Act "Health Law" as amended through July 31, 1991, House Committee on Energy and Commerce, Committee Print 102-L, August 1991, Title VII, Section 701(1); and eliminate the current reference to the now non-existent section of law [701(1)].
Rationale: Inadvertently during the passage of another law [Health Professions Education Extension Amendments of 1992 (P.L. 102-408)], a definition referred to by NIAAA for construction was eliminated. That definition had been referenced in NIAAA's alcohol research center's authority language to prohibit research grant funds from being used for construction; it had served us well for many years. Due to this inadvertent elimination, NIAAA is currently operating without a statutory definition for construction. This proposal will merely reinstate the definition NIAAA had been using.
By placing the definition in NIAAA's own authorizing section, an inadvertent elimination cannot occur again. The definition prevents possible problems in the Administration of grants; i.e., without the definition, disagreements could arise between the Institute and it's grantees as to what constitutes construction and the prohibition against the use of grant funds for construction.
Cost: None.
NIH-1997/36
NATIONAL INSTITUTES OF HEALTH
FISCAL YEAR 2001 DHHS
LEGISLATIVE PROPOSAL
Deletion of Authorization for Earmark
Delete Authorization of Appropriations Cancer Control
Current Law: Section 417B of the Public Health Service Act requires that 10 percent of the National Cancer Institute’s budget be applied to cancer control activities for fiscal year 1996 and for subsequent fiscal years.
Proposal: Delete the authorization of appropriations for cancer control from the Public Health Service Act.
Rationale: Authorizations of appropriations at specific levels restrict NCI’s ability to draw on the planning mechanisms of the Institute. The NCI relies on advice from its staff, its advisory boards and scientific counselors, working groups of non-NCI cancer research experts, and advocacy organizations to determine its priorities and future research directions. These decisions are based on current knowledge as well as the experts’ understanding of likely technological innovations. If specific funding levels are set for research pursuits, the Institute's ability to change direction quickly, and/or fund the most promising research based on scientific merit, is undermined. The specific mandate that 10 percent of NCI’s budget be applied to cancer control reduces the flexibility of the NCI Director to address the priorities set through NCI’s comprehensive planning process, and could slow the Institute’s ability to capitalize on research breakthroughs. Cancer control is part of the NCI’s mandate, and will remain a compelling priority for the National Cancer Program. Elimination of the earmark simply offers the opportunity for NCI to fund the research that is the most promising, most important, and of the greatest potential benefit to the public.
Effect on Beneficiaries: This proposal would benefit the public by enhancing and strengthening the National Cancer Program. It would allow for public research dollars to be expended on the most promising cancer research and it would increase the opportunities for the NCI to make progress in the prevention, treatment and cure of cancer.
Federalism Impact: None
Cost: None
Effective Date: Upon enactment
NIH-1997/37
NATIONAL INSTITUTES OF HEALTH
FISCAL YEAR 2001 DHHS
LEGISLATIVE PROPOSAL
Breast and Prostate Cancer Plans
Delete Requirements for Developing and Submitting to Congress Breast and Prostate Cancer Research Plans.
Current Law: Sections 417(c)(2) and 417A(C)(2) of the Public Health Service Act (the Act) require the National Cancer Institute (NCI) to develop a plan to ensure expansion of activities for breast cancer and prostate cancer research, respectively, for submission to Congress and the President's Cancer Panel.
Proposal: Delete these reporting requirements.
Rationale: These requirements are duplicative. The NCI already has authority through the professional judgement or ByPass Budget mechanism (Section 413(b)(9) of the Act) to alert the President directly to future cancer research opportunities. The ByPass narrative comprehensively describes the broad view of NCI's cancer research plan, and includes very detailed reviews of research plans for both breast and prostate cancer. The ByPass Budget is widely distributed upon request to Congress, research organizations, advocacy groups, and the general public.
The breast and prostate cancer plans submitted in response to this Act were drawn directly from the FY1995 ByPass Budget. Likewise, future research plans in breast and prostate cancer will be included in the NCI ByPass Budget. The Act also requires that the NCI Director include reports of progress made in breast and prostate cancer research in the biennial reporting requirement of the NIH. Therefore, under current law, breast and prostate cancer research plans and reviews are now required to be transmitted through three separate reporting activities. This proposal would reduce this number to two, and reduce the paperwork flowing from NCI through the Department to Congress.
Cost: None.
Personnel Requirements: Negligible.
Effective Date: Upon enactment.
NIH-1997/39
NATIONAL INSTITUTES OF HEALTH
FISCAL YEAR 2001 DHHS
LEGISLATIVE PROPOSAL
Advisory Panel
Repeal section 1902 of the NIH Revitalization Act of 1993.
Current Law: The NIH Revitalization Act of 1993, section 1902, mandates the establishment of an advisory panel to oversee the design, implementation and evaluation of two studies relating to malnutrition in the elderly.
Proposal: Repeal section 1902 of the NIH Revitalization Act of 1993 requiring the establishment of an advisory panel to oversee the design, implementation and evaluation of two studies relating to malnutrition in the elderly and include this proposal in the Omnibus bill "Federal Advisory Committee Termination Act" to delete the requirement for this committee.
Rationale: In lieu of establishing such a committee, National Institute on Aging staff have held numerous meetings with concerned members and staff of the congressional authorizing and appropriation committees, the U.S. Senate Special Committee on Aging, the professional community and other Federal agencies and have kept them informed of efforts to develop a research strategy. This action is consistent with Executive Order 12838, "Termination and Limitation of Federal Advisory Committees" and with OMB A-135, "Management of Federal Advisory Committees," to reduce the number of non- discretionary committees (mandated by statute).
Cost: None.
Personnel Requirements: None.
Effective Date: Upon enactment.
NIH-1997/41
6/14/99
NATIONAL INSTITUTES OF HEALTH
FISCAL YEAR 2001 DHHS
LEGISLATIVE PROPOSAL
Repeal Obsolete Committees
Eliminate certain advisory committees that no longer carry out the purposes for which they were established.
Current Law: The following committees have been established in current law, but no longer carry out the purposes for which they were established:
Proposal: Repeal the sections of current law that established these obsolete committees.
Rationale: This proposal is consistent with the Federal Advisory Committee Act (P.L. 92-463), Executive Order 12838, “Termination and Limitation of Federal Advisory Committees” and with OMB Circular A-135, “Management of Federal Advisory Committees,” to reduce the number of Federal Advisory Committees. The elimination of these committees will result in significant savings of staff time and resources and alleviate unnecessary reporting requirements. The following is a list of the ten committees to be terminated:
Effect on Beneficiaries: None.
Federalism Impact: None
Cost: Adoption of this proposal requires no additional appropriation.
Personnel Requirements: None.
Effective Date: Upon enactment.
NIH-1997/42
6/14/99
NATIONAL INSTITUTES OF HEALTH
FISCAL YEAR 2001 DHHS
LEGISLATIVE PROPOSAL
Centers Authority
Correct an Obsolete Cross-Reference to Construction Definition in NIDA's Multidisciplinary Centers Authority.
Current Law: Section 464N of the Public Health Service Act (42 U.S.C. 285o-2), as added by sec. 123(b) of the ADAMHA Reorganization Act [P.L. 102-321] and amended by sec. 2(a)(4) of the Public Health Service Act Technical Amendments Act [P.L. 102-352], authorizes the Director of the National Institute on Drug Abuse to designate and to make annual grants to multidisciplinary National Drug Abuse Research Centers. This statutory authority, like its model (sec. 464J PHSA administered by the National Institute on Alcohol Abuse and Alcoholism), prohibits use of these grant funds for construction of any building and specifies that "... the term 'construction' has the meaning given that term by section 701(1)[PHSA]." Section 701(1) no longer exists, having been eliminated by legislation (unrelated to the NIDA and NIAAA Centers authorities) enacted on October 13, 1992.
Proposal: Replace the obsolete statutory citation with the definition of “construction” stated in the August 1991 edition of the Health Law volume of Compilation of Selected Acts Within The Jurisdiction of The Committee On Energy And Commerce [Committee Print 102-L], p. 347.
That definition reads as follows:
“The terms ‘construction’ and ‘cost of construction’ include (A) the construction of new buildings, the expansion of existing buildings, and the acquisition, remodeling, replacement, renovation, major repair (to the extent permitted by regulations), or alteration of existing buildings, including architects’ fees, but not including the cost of acquisition of land or offsite improvements, and (B) initial equipment of new buildings and of the expanded, remodeled, repaired, renovated, or altered part of existing buildings; but such term shall not include the construction or cost of construction of so much of any facility as is used or is to be used for sectarian instruction or as a place for religious worship.”
Rationale: Three months after the enactment of NIDA’s sec.
464N Centers authority, Congress enacted the Health Professions Education
Extension Amendments of 1992 [P.L. 102-408]. That law amended Title VII
of the Public Health Service Act generally and, in so doing, removed the sec.
701(1) definition of "construction". As a result, the cross-reference to sec.
701(1) in NIDA's (and NIAAA's) Centers authority has been rendered obsolete and
ineffective. The remedial legislative proposal outlined above may help to
prevent possible future problems in administering the Centers authority and to
enforce compliance with the statutory restrictions on use of grant funds.
Cost: None.
Personnel Requirements: None.
Effective Date: Upon enactment.
NIH-1997/49
NATIONAL INSTITUTES OF HEALTH
FISCAL YEAR 2001 DHHS
LEGISLATIVE PROPOSAL
NHGRI Statutory Designation
Establishment in statute the NHGRI as a National Research Institute of the National Institutes of Health.
Current Law: Section 401 of the Public Health Service (PHS) Act describes the organization of the NIH as being composed of two types of “agencies:” the “national research institutes” and the “entities.” The National Human Genome Research Institute (NHGRI) is listed in Section 401(b)(2) of the PHS Act as an “entity” of the NIH and as the “National Center for Human Genome Research” (NCHGR) in Section 485B of the Act.
Proposal: Update the PHS Act to conform to the Secretary’s administrative action to establish the NCHGR as a national research institute of the NIH.
Rationale: Section 401(c)(1) of Title IV of the PHS Act authorizes the Secretary to establish national institutes at the NIH after providing Congress with a 180 day notice. On July 17, 1996, the Secretary sent letters to the Chairmen and Ranking Members of the Senate Committee on Labor and Human Resources and the House Committee on Commerce notifying the Congress of the Secretary’s intent to exercise this authority with respect to the National Center for Human Genome Research. On January 17, 1997, Secretary Donna Shalala conferred institute status on the NHGRI.
The change from an “entity” to an “institute” was budget neutral and did not require an increase of funds or of FTEs. It also did not result in any reorganization or affect employee grades or pay, since the NCHGR already had been organized in the same way as the NIH institutes.
The proposal, therefore, is technical, and necessary to conform the PHS Act to the action already taken by the Secretary in establishing the NHGRI as one of the national research institutes under Section 401.
Cost: None
Personnel Requirements: None
Effective Date: Upon enactment.
NIH-1997/50
NATIONAL INSTITUTES OF HEALTH
FISCAL YEAR 2001 DHHS
LEGISLATIVE PROPOSAL
Cord Blood Donor Confidentiality
Extend Existing Donor Confidentiality Protections to Cord Blood Donors.
Current Law: Section 379 of the Public Health Service Act establishes a National Bone Marrow Donor Registry, and requires, in section 379(c)(5), confidentiality standards to protect marrow donors or potential marrow donors for an unrelated patient. Current law does not include protection for a new class of donors, i.e., infants who donate cord blood stem cells for transplantation.
Proposal: Extend the current confidentiality protections to encompass donors from whom cord blood stem cells are collected at birth for transplantation to unrelated recipients.
Rationale: Cord blood stem cell transplantation donors are not covered by the confidentiality protections the law now provides for bone marrow donors. Such provisions are ethically essential, as situations may arise after transplantation in which the recipient is believed to need additional bone marrow, peripheral blood lymphocytes, or peripheral blood stem cells from the original donor. Donors of cord blood stem cells would have already provided a substantial benefit to the recipient. Neither they nor their families should be exposed to requests for additional marrow or blood that would require invasive and sometimes risky procedures.
Effect on Beneficiaries: Individuals transplanted with cord blood stem cells will not be able to identify the donor if they need additional marrow or blood transplants. The families of donors will not have their identities revealed to recipients. This is consistent with current law protecting the privacy of bone marrow donors.
Federalism Impact: This proposal does not directly regulate States nor interfere with or displace essential State functions. It does not attach conditions to grants that are not related to the purpose of the grant or preempt State Law as discussed in E.O. 12612.
Cost: None.
Effective Date: This provision should be effective upon enactment.
NIH-1997/52
6/14/99
NATIONAL INSTITUTES OF HEALTH
FISCAL YEAR 2001 DHHS
LEGISLATIVE PROPOSAL
Threshold Levels for Council Review
Increase grant and cooperative agreement amounts that may be made without National Advisory Council recommendations.
Current Law: Section 405[284](b)(2)(B)(i) and (ii) state that Institutes may award research and training grants and cooperative agreements only if recommended after technical and scientific peer review, and in the case of awards exceeding $50,000 direct cost, only if additionally recommended by the National Advisory Councils.
Proposal: Increase, to $100,000 the direct cost dollar amount for grant and cooperative agreement awards that can be made after scientific and technical peer review but without Council recommendation, and extend this provision to the other agencies of the National Institutes of Health.
Rationale: The proposed changes would update the previously established threshold levels to more accurately reflect contemporary award levels for individual grants, and would enable the Institutes, Centers, and the National Library of Medicine to better organize their workloads and shorten the time from review to award of applications. These changes are consistent with streamlining and reinvention activities at the National Institutes of Health.
Federalism Impact: None
Cost: None
Effective Date: Upon enactment
NIH-1997/53
6/14/99
NATIONAL INSTITUTES OF HEALTH
FISCAL YEAR 2001 DHHS
LEGISLATIVE PROPOSAL
National Advisory Meetings
Allow the Director, Institute heads, and heads of other agencies and entities of NIH to call meetings of advisory councils and committees on an as-needed basis.
Current Law: Sections 406[284a](e), 406[284a](h)(2)(A)(vi), and 406[284a](h)(2)(B) state that the advisory council for each national research institute shall meet at least three times each fiscal year, except that the advisory councils for the National Cancer Institute and the National Heart, Lung, and Blood Institute shall meet at least four times each fiscal year; Section 480[287a](e) states that the advisory council of the National Center for Research Resources shall meet at least three times each fiscal year. Additional requirements regarding frequency of meetings include: President’s Cancer Panel, Section 415(a)(3); Diabetes Mellitus Interagency Coordinating Committee, Digestive Diseases Interagency Coordinating Committee, and Kidney, Urologic, and Hematologic Diseases Interagency Coordinating Committee, Section 429(b); Arthritis and Musculoskeletal Diseases Interagency Coordinating Committee and Skin Diseases Interagency Coordinating Committee, Section 439(b), Deafness and Other Communication Disorders Interagency Coordinating Committee, Section 464E(d), and National Institute of Nursing Research Advisory Council, Section 464X(e) PHS Act).
Proposal: Allow the NIH Director, NIH national research institutes, and other components of NIH, to convene advisory councils/committees on an as-needed basis and eliminate all specific statutory requirements for frequency of such meetings.
Rationale: The proposed changes would provide flexibility to the NIH Director and each component of the National Institutes of Health (NIH) with respect to the number of advisory council/committee meetings held per year. As a result of ongoing streamlining and reinvention at the NIH, including the increasing use of electronic communications media, three (or four) advisory council meetings per year may be excessive. Unneeded meetings are wasteful of resources, including time and effort on the part of both council/committee members and staff and travel expenses and compensation for council/committee members.
Cost: If agencies of the NIH use the requested flexibility to convene advisory council meetings less frequently than required by current statute, some savings will be realized; the amount is difficult to estimate.
NIH-1997/54
6/14/99
NATIONAL INSTITUTES OF HEALTH
FISCAL YEAR 2001 DHHS
LEGISLATIVE PROPOSAL
Mandated Research and Progress Reports
Eliminate or Modify Certain Mandated Research and Progress Reports Submitted by the Director of the NIH and the ICs.
Current Law: Under current law, the Director, NIH, Directors of ICs, and NIH components are required to furnish research, progress, and administrative reports to the Secretary or the Congress. See attached list for specific references.
Proposal: Eliminate or modify the requirement of the NIH, the ICs, and other NIH components to provide written reports to the Secretary or the Congress. In order to accomplish this, the Office of the Director, NIH, and the IC Directors have identified the attached list of reports, which are considered wasteful, unnecessary, and an overburden to the NIH.
Rationale: The proposed elimination of these reports or modification of reporting requirements is in accordance with The Paperwork Reduction Act, and with the principles of Vice President Gore’s National Performance Review in as much as they provide a constant burden of the federal workforce. The reports to be eliminated or modified are identified by NIH components in the attachment.
It is proposed that the elimination of these reports or modification of reporting requirements will improve the efficiency of the individual ICs and the NIH in general, by allowing staff to concentrate on the administration of research programs, rather than producing reports for the Congress that are no longer useful. This legislative proposal is consistent with current efforts of streamlining and reinventing Government to make it more efficient and by reducing the burden in the federal workforce, and thereby saving taxpayers money.
Cost: None
Personnel Requirements: Reduction in personnel time and cost.
Effective Date: Upon enactment.
ATTACHMENT
Mandated Reports Elimination/Modification
NIA
Report of the Task Force on Aging Research
Title III of P.L. 101-557 requires the establishment of the Task Force and an annual report to be submitted to the Secretary and to the Congress. National Institute on Aging (NIA) requests that the report be eliminated for three reasons: 91) TFAR is redundant–agencies compromising TFAR already meet as members of the Ad Hoc Interagency Committee on Research on Aging and the Federal Council on Aging Statistics to exchange information and discuss aging research priorities; (2) preparing the TFAR report is a resource-intensive exercise that duplicates efforts involved in the NIA strategic planning process; and (3) the public information/education goals of TFAR are being achieved through a variety of electronic and multi-media strategies initiated since the inception of TFAR.
NIAMS
Arthritis and Musculoskeletal and Skin Diseases Advisory Board Annual Report
[42 USC 285d-7] [Section 442(j) of the PHS Act]
The current charter for this Board expired September 30, 1994, and the Secretary has stated that DHHS will not renew the existing charter. Also, in the 103rd Congress, Senator John Glenn introduced legislation (S. 2463) that would repeal the language establishing this Board. The legislation may be reintroduced in the 105th Congress.
NICHD
Sudden Infant Death Syndrome Research Reports
[42 USC 300c-12] [Title XI, Sections 1122(b) and (c), PHS Act]
Sections 1122(b) and (c) of the PHS Act require two extensive annual reports that are of very limited value to the Congress (or anyone). The authors of these requirements enacted in 1974, former Senators Cranston and Mondale, have long since departed the Congress. SIDS advocacy groups are not likely to oppose the elimination of these two reports.
NIDA
Triennial Report on Drug Abuse
[42 USC 290aa-2] [Title V, Section 503(b)]
The requirement for the Triennial Report on Drug Abuse should be eliminated because this information is already available in a much more timely manner through NIDA publications and through the budget process. Since the enactment of this reporting requirement, NIDA has developed enhanced mechanisms for informing the public and the Congress of important research progress, including monographs and publications such as NIDA notes.
NIAAA
Alcohol and Health – [42 USC 290aa-2] [Title IV, Section 503(a)]
Retain the statutory reporting requirement, but change the frequency to every five years. Current law requires the Secretary to submit to Congress every three years a report (1) containing current information on the health consequences of using alcoholic beverages, (2) containing a description of current research findings made with respect to alcohol abuse and alcoholism, and (3) containing such recommendations for legislation and administrative action as the Secretary may deem appropriate.
NIDDK
The following advisory committee reports have been recommended for termination by NIH, DHHS, and OMB.
Report of the End-Stage Renal Disease Data Advisory Committee – [42 USC 1395rr(c)(7)]. Established by the Secretary February 28, 1990, as amended by P.L. 99-509. This Committee is governed by provisions of P.L. 92-463 as amended.
Section 440A of P.L. 94-562 in 1976 created the Digestive Diseases Interagency Coordinating Committee, which was reauthorized in 1986 by P.L. 99-158. P.L. 99-158 also created the Diabetes Mellitus and the Kidney and Urologic Diseases Interagency Coordinating Committees. In the interest of streamlining Federal activities, the utility of the following annual reports does not justify their continuance:
Report of the Digestive Diseases Interagency Coordinating Committee
Report of the Diabetes Mellitus Interagency Coordinating Committee
Report of the Kidney and Urologic Diseases Interagency Coordinating Committee
[42 USC 285c-3] [Title iv, Section 429, PHS Act]
OSP/OD
Biennial Report of the Director, NIH
[42 USC 283] [Title IV, Section 403 PHS Act]
Eliminate the requirement in Section 403, PHS Act, for the preparation and transmittal to the President and the Congress of the Biennial Report of the Director, NIH. All other requirements for submissions to this report found elsewhere in law should also be eliminated. The information in the report is available in a more timely manner through the Congressional Justification and other documents provided to Congress on an annual and regular basis. Elimination of the report would save resources that could be expended on other necessary activities.
NIDCD
Report of the Deafness and Other Communication Disorders Interagency Coordinating Committee [42 USC 285m-5] [Section 464E(e) of the PHS Act]
Eliminate the requirement for a report of the Deafness and Other Communication Disorders Interagency Coordinating Committee. Pending legislative proposal NIH-1997/53 would change meeting requirement of the Committee to an “as needed basis,” making reporting as statutorily mandated (“not later than 120 days after the end of each fiscal year”) difficult. In lieu of report, exchange of Committee information to occur through List Serve mechanism.
NIH-1997/56
NATIONAL INSTITUTES OF HEALTH
FISCAL YEAR 2001 DHHS
LEGISLATIVE PROPOSAL
Eliminate Earmarks
Eliminate designated provisions of law that provide earmarks for NIH programs.
Current Law: Current law contains several unnecessary earmarks for NIH programs. Specifically, these include earmarks for an elderly research center funded by NIAAA and for a designated number of breast cancer and prostate cancer research centers (specialized programs of research excellence--SPOREs) funded by NCI. NIH already has sufficient authority to conduct its programs, and these specific earmarks should be eliminated.
Section 464J of the PHS Act requires the Secretary to make a grant for research on the effects of alcohol on the elderly. Section 417 of the PHS Act requires the Director, NCI, to conduct or support research to expand the understanding of the cause of, and to find a cure for, breast cancer, including the establishment of six breast cancer centers. Similar language is contained in Section 417A of the PHS Act for prostate cancer.
Proposal: Amend NIH statutory authorities by eliminating specific earmarks for an elderly research center funded by NIAAA and the numerical designation of six centers for breast cancer research and six centers for prostate cancer research (specialized programs of research excellence--SPOREs) funded by NCI.
Rationale: In recent years the Congress has enacted numerous statutory earmarks for NIH programs despite the fact that NIH already has sufficient authority to conduct these programs. These earmarks are unnecessary and reduce the flexibility of NIH to adjust priorities to meet changing research needs and opportunities. The earmarks require the establishment and funding of centers and other research programs, provide set-asides of appropriated funds, or contain time-and-dollar-limited authorizations of appropriations for specific NIH programs. These programs should compete for funding as do other programs and, if deemed meritorious, can be continued without the necessity of earmarking funds. NIH has the appropriate peer-review mechanisms in place to ensure that federal dollars are allocated to the most meritorious research programs. Statutory earmarks bypass these mechanisms and arbitrarily require continued funding without permitting an assessment of these programs during times of reduced funding or changing research priorities and opportunities. The national biomedical research effort has a continuing need for such reassessments and can no longer afford, particularly during times of fiscal constraint, to be driven by decisions set in statute in previous years.
Specific earmarks designated in the proposal for elimination are those for an elderly research center funded by NIAAA and the numerical designation of six centers for breast cancer research and six centers for prostate cancer research (specialized programs of research excellence--SPOREs) funded by NCI.
· Elderly Research Center--In the Omnibus Budget Reconciliation Act of 1981, the National Alcohol Research Center grant authority language was changed to require the Secretary to "include in the grants made under this section for fiscal years beginning after September 30, 1981, a grant to a designated Center for research on the effects of alcohol and the elderly.” The same section of law did then, and continues to, provide requirements that the Secretary not approve an application unless it is worthy according to several guidelines.
Elderly research is an area of directed science for NIAAA. Generally research grant applications are approved in the 150-160 priority score range, which is considered superb science; we have received some applications that scored 130 or better. Because the elderly center is directed by law and we only received three grant applications in our last application cycle (two of which were non- responsive to the RFA and unfundable with scores of 298 and 298), our current elderly center grant was approved at a score of 186. This is just about fundable. This center is in its second year of a 5- year approval and the new principal investigator at the Center is making improvements.
When this center's five year grant is up for renewal, NIAAA would prefer not to be in a position where we are forced to fund grant applications receiving lower priority scores and not fund others which received higher scores. In addition, the basic science at the cellular level of gerontology, much less alcohol and aging, is narrow and in its infancy; therefore, we may not receive any fundable applications in the next review cycle. We will then be caught between two conflicting portions of law: one forbidding the funding of poor science, and the other requiring us to fund elderly research.
· Specialized Programs of Research Excellence (SPOREs)--In 1992, the NCI developed SPORE grants concept to foster the translation of basic discoveries into innovative clinical testing and eventual treatment advances in cancer research. Four full SPOREs and five planning grants (P20s) for breast cancer were awarded in 1992. In Fiscal Year 1995, NCI will reissue a Request for Application (RFA) to solicit proposals to fund at least one to two additional breast cancer SPOREs.
There are currently two prostate cancer SPOREs. NCI will reissue Request for Applications (RFA) to solicit new and competing proposals with the aim of funding one to two additional prostate SPORES in 1995.
Breast and prostate cancer are high priority issues for NCI. However, given the uncertainty of budget and high quality applications in any given year, flexibility to support high priority research in these tumors should be the criterion for supporting SPOREs.
Effect on Beneficiaries: The proposal would benefit the national biomedical research effort and would not diminish the opportunity to fund meritorious programs.
Federalism Impact: This proposal does not directly regulate States or interfere nor displace essential State functions; attach to grants conditions that are not related to the purpose of the grant; or preempt State law as discussed in E.O. 12612.
Authorization Level: None.
Personnel Requirements: No additional FTEs are required.
Effective Date: Upon enactment.
NIH-98/34
NATIONAL INSTITUTES OF HEALTH
FISCAL YEAR 2001 DHHS
LEGISLATIVE PROPOSAL
Personal Services Contracts
Provide Authority to Use Personal Services Contracts.
Current Law: Civil service laws and 48 CFR 37.104 prohibit the use of personal services contracts unless specifically authorized by statute.
Proposal: Amend the Public Health Service Act to provide the Warren Grant Magnuson Clinical Center, NIH, with the authority to award personal services contracts to meet the operational challenges associated with the Clinical Center's dynamic research and patient care needs.
Rationale: The Clinical Center, the clinical research facility of the National Institutes of Health intramural programs, was established to facilitate the translation of basic science discoveries of intramural and extramural investigators into clinical applications that advance human health and address the nation's health needs. As the world's largest clinical research facility, the Clinical Center provides the intellectual and physical resources necessary to provide rapid responses to a wide spectrum of new research opportunities and agendas. The provision of quality, efficient, and coordinated service and care is essential to accomplishing the clinical research mission of the Clinical Center. Current personnel systems and contract mechanisms limit the Clinical Center from hiring highly specialized employees in a timely fashion, at competitive salaries, for varying lengths of service. Efficiency and performance management are further confounded because mechanisms prevent the continuous supervision and control of contractor staff by Clinical Center employees. This proposal is designed to provide the Clinical Center with alternative methods of securing personnel necessary to meet the needs of our patients, NIH investigators, and the public health constituency. The following examples illustrate the flexibility that personal services contracts would afford the Clinical Center:
Information Systems Support:
The dynamic nature of clinical and administrative information technology requires constant upgrading of existing and development of unique information systems to meet the needs of the Clinical Center investigators, clinicians, and administrators. Authority to use personal services contracts would provide a mechanism to secure skilled employees with highly specific, technical expertise for short term assistance. The personal service contract arrangement would allow Clinical Center employees to supervise directly these employees.
Specialized Clinical Care:
Clinical research protocols often require the provision of specialized clinical care for a defined period of time. Permanent Clinical Center employees may not have the specific expertise necessary to support a clinical research initiative. For example, a three-year clinical research protocol may involve a large volume of patient activity requiring a highly technical clinical intervention (e.g., hemodialysis) that the Clinical Center nursing department or other clinical departments are unable to support with the available skill mix. Personal service contracts would allow the Clinical Center to hire specialized practitioners, for varying lengths of time, at competitive wages to provide services, that otherwise are not necessary for hospital operations or patient care. This contract arrangement will provide the Clinical Center with the personnel resources necessary to meet the changing clinical research agenda.
Medical Consultative Services:
Clinical Center patients often require specialty or subspecialty medical care not available at the Clinical Center (e.g., orthopedic surgery, podiatry, gastroenterology). To assure quality care for these Center patients, services must be available; however, the generally low volume needs for these specialized services does not warrant hiring a full-time permanent medical staff employee. In addition, the inability to compensate medical staff under current government pay systems complicates the ability to secure quality practitioners. Historically, the CC has used a variety of arrangements, formal and informal, to provide these services. Because of the informal nature of many of these service arrangements, the availability and quality of consultative clinical care has not been consistent. The restriction against federal employees directly supervising contract employees has made assuring quality extremely difficult. Personal services contracts would provide a means to secure and pay medical staff to provide consultative services to patients and to allow the Clinical Center to assess directly the quality of care and services provided.
Rationale: The primary benefit of this proposal is the provision of a flexible mechanism to enable the Clinical Center to hire highly specialized personnel at competitive salaries for varying lengths of time. This contract mechanism will allow the Clinical Center to hire staff with specialized skills that would otherwise not be necessary for routine care of patients or operations of the hospital, making long term employment of these staff unnecessary. Use of personal services contracts will permit Clinical Center staff to supervise and direct personal services contractors' activities, an action that is currently prohibited under standard contract mechanisms. The use of personal services contracts will facilitate the assessment of the quality of service provided by individual contract personnel. Use of personal services contractors will shorten the time required to obtain crucial services and decrease the overhead requirements for such contractors, since the government will not be required to pay benefits.
Federalism Impact: This proposal does not regulate States or interfere nor displace essential State functions, or preempt State law as discussed in E.O. 12612.
Authorization Level: No sums requested.
Personnel Requirements: No additional FTE are required.
Effective Date: Upon enactment.
NIH-1998/50
NATIONAL INSTITUTES OF HEALTH
FISCAL YEAR 2001 DHHS
LEGISLATIVE PROPOSAL
Blood and Blood Products
Repeal of 24 USC § 30 Regarding Compensation for Blood and Blood Products Collected for Biomedical Research.
Current Law: Section 30 of Title 24 of the U.S. Code provides for reasonable monetary reimbursement for blood collection for transfusion into a person undergoing treatment at Government expense or for blood banks or for use in research in connection with the care of any person entitled to treatment at Government expense and sets a limit of $50.00 for compensation for blood withdrawal.
Proposal: Repeal Title 24 U.S. Code, section 30 to be consonant with current DHHS policy for the maintenance of an “all volunteer” blood donor program and to eliminate the $50.00 cap for compensation for blood collections. This repeal is consistent with the maintenance of an “all volunteer” blood donor program for patient care and allow institutions to develop appropriate compensation policy for the collection of blood for research purposes.
Rationale: The Warren Grant Magnuson Clinical Center (Clinical Center), the clinical research facility of the National Institutes of Health intramural programs, was established to facilitate the translation of basic science discoveries of intramural and extramural investigators into clinical applications that advance human health and address the nation’s health needs. The safe and efficient collection of blood and blood products for patient care and biomedical research purposes is critical to the mission of the Clinical Center.
The Clinical Center uses an “all volunteer” blood donor program, as recommended by the Department of Health and Human Services in 1973, to collect blood and blood products for clinical/patient care use. Currently, the Clinical Center does not compensate for donations that are for patient use, in accordance with DHHS recommendations, but does compensate for blood and blood products used for biomedical research purposes, based on the complexity of the procedure used for collection, according to existing NIH policy. However, existing federal statutory requirements indicate that persons who furnish blood to be used for clinical and/or biomedical research are “entitled” to receive compensation, and that compensation is not to exceed $50.00 per blood withdrawal.
This law poses impediments to an “all volunteer” donor program for blood collected for clinical/patient care use by entitling persons to compensation for patient care/non-research donations and also imposes limits on compensation for persons providing blood and blood products for biomedical research purposes. The Clinical Center requests a repeal of the existing law to eliminate entitlement to monetary compensation for blood and blood products collected for patient care use and to eliminate the current $50.00 compensation cap per blood withdrawal to allow for appropriate compensation for blood collected for research purposes.
US Code, Title 24, section 30, enacted in 1927 and amended in 1939 and 1941, poses substantial impediments to the collection of a safe and adequate supply of blood and blood products at the Clinical Center. The current law indicates that “any person....who shall furnish blood from his or her veins for transfusion into the veins of a person...or who shall furnish blood for blood banks or for other scientific and research purposes...shall be entitled to be paid therefore such reasonable sum, not to exceed $50, for each blood withdrawal....” In July 1973, the Secretary, US Department of Health, Education, and Welfare, announced the move to a national “all volunteer” blood donor program in an effort to counter the increase in viral hepatitis transmitted by blood transfusions. The establishment of an “all volunteer” donor program has increased significantly the safety of our country’s blood supply. Currently, the Department of Transfusion Medicine (DTM), Clinical Center uses only volunteers for the collection of blood and blood products for transfusions or other clinical purposes. The DTM still offers compensation for collection of blood and blood products to be used solely for the purpose of biomedical research as outlined in NIH policy 3010.
Since the enactment of US Code Title 24, section 30, transfusion medicine technologies and practices have changed dramatically. Blood and blood products collection techniques have been developed (e.g., pheresis including platelet pheresis, stem cell harvesting, cytopheresis, among others) that: are associated with greater discomfort and inconvenience for the person furnishing the blood; require a longer time commitment (e.g., two to four hours versus 30 minutes for whole blood collection); may require premedication; and/or require the collection of a greater volume of blood for processing. The $50.00 compensation limit set in 24 USC 30 is not consonant with the added complexities and inconveniences associated with the current blood collection techniques. Repeal of this law will eliminate this compensation cap and will allow individual institutions the latitude to establish reimbursement fees for research subjects commensurate with modern blood collection techniques.
Effect on Beneficiaries: The primary benefit of the proposal will be to eliminate the law that is in conflict with the current DHHS policy for an “all volunteer” donor program for collection of blood for patient care use. Additionally, the proposal will give health care institutions the latitude to set institution-specific policy regarding compensation for the collection of blood and blood products for biomedical research purposes that is commensurate with the complexity of the blood collection technique.
Federalism Impact: This proposal does not regulate States or interfere nor displace essential State functions, or preempt State law as discussed in E.O. 12612.
Authorization Level: No sums requested. The budgetary impact of repeal of US Code Title 24, section 30 will be modest. No funds will be expended to compensate “volunteer” donors that provided blood and blood products for patient care use. Compensation for blood and blood products used for research purposes has been directed by NIH policy 3010 since 1986 (revised 1990). The current compensation rates outlined in NIH policy 3010 have been used since 1990 and are unlikely to increase.
Personnel Requirements: No additional FTEs are required.
Effective Date: Upon enactment.
NIH-2000/01
6/14/99
NATIONAL INSTITUTES OF HEALTH
FISCAL YEAR 2001 DHHS
LEGISLATIVE PROPOSAL
Extramural Clinical Research Loan Repayment
Authorize an extramural clinical research loan repayment program for the NIH in order to provide recruitment and retention incentives for clinical researchers.
Current Law: There is no current authority for an extramural clinical research loan repayment program under which the Director, NIH, may provide an incentive for health professionals to conduct extramural clinical research. Section 487E of the PHS Act describes the NIH LRP regarding health professionals from disadvantaged backgrounds who become employees of the NIH. That program pertains to health professionals who will commit to working as intramural clinical researchers of the National Institutes of Health. Although the NICHD does have an extramural LRP focused on contraception and infertility research (Section 487B), there is no extramural LRP for general clinical researchers.
Proposal: Amend the PHS Act to provide an NIH loan repayment program under which the Director, NIH, is authorized to (1) identify areas of extramural clinical research for which specific loan repayment benefits may be awarded and (2) contract with qualified health professionals to conduct such research with respect to these research areas for a minimum of two years in exchange for the Government’s repayment, for each year of such research service, of not more than $35,000 of principal and interest of the extant educational loans of such health professionals. Health professionals eligible to participate in this program include investigators engaged in clinical research. Examples include, but are not limited to NIH grantees at research institutions, universities, medical schools, and hospitals.
Rationale: The national biomedical research effort has a continuing need for qualified physicians and scientists to train in and conduct medical research in a wide range of research areas, including clinical research. High educational debt burdens of health professionals and competing employment opportunities continue to make it difficult to attract qualified physicians and scientists to engage in research activities. The cost of medical education is so high that many individuals have no choice but to enter clinical practice as soon as they graduate. According to the Association of American Medical Colleges, 50.5% of medical school graduates who graduated in 1994 had more than $50,000 in educational debt, while 27.2% had educational debt of more than $75,000. With recent changes in the availability of deferment of repayment, and interest accruals commencing during residency and internship training periods, many physicians report that they are precluded from considering additional research training and, specifically, careers in research. This proposal is designed to counter the growing economic disincentives to embark on research careers, and to provide an incentive to engage in clinical research. The program is expected to attract highly qualified applicants and will encourage the commitment of these health professionals to sustaining a career in clinical research. The program would benefit individuals who have incurred substantial educational debt during their professional training.
Authorization Level: Such sums as necessary.
Personnel Requirements: None.
Effective Date: Upon enactment.
NIH-2001/01
6/14/99
NATIONAL CANCER INSTITUTE
FISCAL YEAR 2001 DHHS
LEGISLATIVE PROPOSAL
Long Island Breast Cancer Study Project
Extend Authorization for the Long Island Breast Cancer Study Project .
Current Law: P.L. 103-43, Sec. 1911 amended the Public Health Service Act* (the Act) to require that a study of potential environmental and other risks contributing to incidence of breast cancer on Long Island be conducted by the National Cancer Institute and the National Institute on Environmental Health Sciences. Such sums as necessary were authorized for fiscal years 1994 and 1995; the study was required to be completed within 30 months of enactment.
*The text from this law is not included in the 1997 publication of the PHS Act. Therefore, all citations refer to the public law.
Proposal: Extend the authority for the Long Island Breast Cancer Study Project for five years.
Rationale: The grants funded to conduct this research will be completed during 1999 and 2000; peer- reviewed articles on research findings to date have been published, and the largest projects are expected to publish results in peer-reviewed journals during 2000. Extension of that authorization for five years (such sums as necessary) will allow the research to be completed.
Federalism Impact: None.
Cost: No additional costs over those projected at award.
Effective Date: Upon enactment.
NIH-2001/02
6/14/99
NATIONAL CANCER INSTITUTE
FISCAL YEAR 2001 DHHS
LEGISLATIVE PROPOSAL
Prostate Cancer Research
Extend Authorization for Expansion and Coordination of Activities on Prostate Cancer Research.
Current Law: Sections 417A and 417B(c)of the Public Health Service Act (the Act) require the National Cancer Institute (NCI) to expand, intensify, and coordinate activities for prostate cancer research. $72 million was authorized in FY1994; such sums as necessary were authorized for FY1995 and FY1996.
Proposal: Extend authority for prostate cancer research for five years.
Rationale: Prostate cancer is a disease which commands intense interest from the public, the Congress, and from the medical and research communities. Extending NCI’s authority will demonstrate the Federal government’s commitment to understanding and eradicating this disease. It sends a message to the research community that NCI continues to emphasize expanding knowledge of prostate cancer and that momentum must be maintained as we are poised to discover new tumor markers and prognostic indicators, design individualized treatment, understand biology, and determine genetic influences. The NCI recently received recommendations from the Prostate Cancer Review Group on future research directions, and an implementation plan is under development.
Federalism Impact: None.
Cost: Such sums as necessary.
Effective Date: Upon enactment.
NIH-2001/03
4/7/00
NATIONAL INSTITUTES OF HEALTH
FISCAL YEAR 2001 DHHS
LEGISLATIVE PROPOSAL
Parkinson’s Disease Research
Reauthorize appropriations for funds to conduct research focused on Parkinson’s disease.
Current Law: Section 409B(e) of the Public Health Service Act authorized $100 million for FY 1998 and such sums for FY 1999 and FY 2000.
Proposal: Reauthorize appropriations for Parkinson’s disease for five years.
Rationale: This program is essential to advancing treatment of this crippling disease.
CDC-1997/04
1/7/00
CENTERS FOR DISEASE CONTROL AND PREVENTION
FISCAL
YEAR 2001 DHHS LEGISLATIVE PROPOSAL
Sworn Agent Designation
Authorize NCHS/CDC to Designate Sworn Agents to Perform Statistical Activities.
Current Law: The Census Bureau is authorized (13 U.S.C. 23) to use temporary staff to assist in performing its statistical activities if these employees are sworn to comply with Census Bureau restrictions on use of information and are subject to sanctions for misuse. The National Center for Health Statistics (NCHS), CDC, has no corresponding authority. NCHS has strong confidentiality protections afforded by Sec. 308(d) of the Public Health Service Act.
Proposal: Authorize NCHS to designate sworn agents to perform exclusively statistical activities authorized by law.
Rationale: NCHS recognizes the importance of maintaining confidentiality protections so that survey respondents can be sure that personal information that they provide for statistical purposes will be maintained in a confidential manner. Given the investment in data collection mechanisms and the value to be derived from maximizing the analytic potential of the data collected, it is important to the health community that NCHS foster the widest possible use of data within the bounds of its commitment to confidentiality.
The Census Bureau has statutory authority to designate special sworn employees subject to the same confidentiality requirements as Census employees to assist in analysis of Census data. A similar model could be used by NCHS. Sworn agents would use the NCHS data only for the purposes for which they were collected and would be allowed access to confidential data files only under tightly restricted conditions to ensure that confidentiality of the data would not be jeopardized. These agents would be subject to the provisions of 308(d) of the Act as well as any penalties for inappropriate disclosure to the same extent as an NCHS employee.
Such an arrangement would expand the range of worthwhile research that could be conducted using NCHS data, would allow researchers to pursue greater analytic linkages between different data sets, and would allow NCHS to work more closely with other agencies to meet their data needs - all of which would result in increased knowledge and benefits to the public. A provision to allow NCHS to designate sworn agents as described above was included in a legislative proposal - the “Statistical Confidentiality Act” - submitted to the Congress in April 1996. The proposal was introduced in the House (H.R. 3924) in the 104th Congress. The proposal would expand and improve the research opportunities available to NCHS data users.
Cost: None.
Additional Information: The provisions requested in this proposal are contained in H.R. 2885, the Statistical Efficiency Act of 1999, under consideration by the 106th Congress, introduced on September 21, 1999, and which passed the House on October 26, 1999.
CDC-1999/01B
12/7/98
CENTERS FOR DISEASE CONTROL AND PREVENTION
FISCAL
YEAR 2001 DHHS LEGISLATIVE PROPOSAL
Breast/Cervical Cancer Prevention -- Percentage Requirements
Revise percentage spending requirements for the National Breast and Cervical Cancer Early Detection and Control Program.
Current Law: Title XV of the PHS Act establishes CDC’s Breast and Cervical Cancer Early Detection Program. The current law requires grantees to spend at least 60 percent of the grant on screening for breast and cervical cancer, referrals for treatment, and assurance of follow-up services and no more than 40 percent of the grant for public information and education, professional education and training, monitoring screening quality and evaluation of activities.
Proposal: Authorize the Secretary to waive the specific percentage requirement for grantees receiving $750,000 or less annually while continuing to require that all activities of this program be carried out.
Rationale: The overall quality and strength of CDC’s Breast and Cervical Cancer Early Detection Program, which currently funds grantees at an average of $2.0 million per program per year, is based in large part on the viability of the grantee’s public health infrastructure. In the context of this program, “infrastructure” means having the capacity to implement, through the existing public health system, the five key components or the program: screening and follow-up, public education, professional education, surveillance, and evaluation. Screening and follow-up benefit uninsured women in the grantee’s jurisdiction; other elements of the program benefit all women in the grantee’s jurisdiction.
The majority of grantees have a fully developed public health infrastructure and are capable of expending 60 percent of their grant funds effectively on screening, referral, and follow-up service to the eligible populations. However, approximately 10 small grantees (Indian Tribes, Tribal Organizations, Territories and a few States which receive less than $750,000 per year) have special circumstances and are unable to expend their grant in accordance with existing percentage spending requirements. Specifically, these small grantees have greater public health infrastructure needs, and smaller populations of uninsured women requiring screening and follow-up. The current 60/40 rule does not allow these grantees, in particular, the flexibility to dedicate the necessary resources to develop their public health infrastructure in order to be able to implement the program over time in an effective manner. For example, these grantees need additional flexibility to recruit appropriate staff, train health providers, implement case and data management systems, conduct public education and outreach to increase participation in screening, and conduct public education and outreach to increase the number of women who participate in screening. By allowing the Secretary to waive the 60/40 rule, these small grantees would have the flexibility to develop the infrastructure they will need in order to meet their screening requirements in the long term and to achieve the objective of promoting the importance of screening to all women and health care providers in their jurisdiction.
CDC would continue to provide TA and monitor grantees. Moreover, through this process, CDC will assist these small grantees in implementing a program that would allow for greater flexibility in setting an appropriate balance between the screening and other infrastructure components in the Program.
Cost: None.
CDC-1999/01D
12/7/98
CENTERS FOR DISEASE CONTROL AND PREVENTION
FISCAL
YEAR 2001 DHHS LEGISLATIVE PROPOSAL
Breast/Cervical Cancer Prevention -- Demonstration
Expand the demonstration program authorization for preventive health services grants.
Current Law: Title XV of the PHS Act established CDC’s National Breast and Cervical Cancer Early Detection Program (NBCCEDP). Section 1509 of this Title permits establishing, a demonstration project, in three states, for essential preventive health services (including blood pressure and cholesterol screening) in addition to breast and cervical cancer screening.
Proposal: Eliminate limitation on the number of states that may participate in demonstration programs.
Rationale: Currently, this demonstration program is the only public health program that specifically targets uninsured and underinsured women aged 50 years and older with health promotion program (nutrition and physical activity) and preventive health services. CDC already has initiated important demonstration projects in three states as allowed by law. The three-state restriction precludes needed testing and evaluation of project variations. By removing the three- state limit in the current authority, it would be possible to test and evaluate the effectiveness of implementing comprehensive preventive services approaches with women in other geographic areas and, in particular, to test and evaluate programs tailored to the health needs of special populations of women.
In currently participating states, the demonstration projects have been integrated effectively into the existing NBCCEDP program at many sites, served more than 3600 women, and identified large numbers of women with abnormal cholesterol or blood pressure levels (almost 90% in one demonstration program). Participating States and local health clinics are highly supportive of developing integrated services approaches, wherein women being screened for breast and cervical cancer also can be screened for blood pressure and cholesterol levels and be offered pertinent information (health education). Preliminary data from the program indicate that integrated approaches of this type offer States vital prevention opportunities within populations that are at very high risk of developing chronic diseases, such as heart disease and diabetes (uninsured or underinsured women aged 50 years and older). Future program activities will be based on evaluations now in process.
Because the current demonstrations are so limited in size, scope, and location, testing and evaluation in sites in additional states is vitally important to the development of model programs. For example, existing programs are not statewide and meet the screening needs of only a small portion of eligible women. Moreover, special populations (Urban Black, American Indian, Asian American women) are not being targeted in the current demonstrations.
In summary, revising the law to remove the limitation on the number of States in which demonstrations can be conducted would permit initiating innovative projects to test and evaluate approach variations, particularly approaches for special populations of women. These additional demonstrations and evaluations would enhance substantially the science base for designing and implementing appropriate screening and intervention programs in the future.
Cost: No funds requested.
CDC-1999/02A
12/7/98
CENTERS FOR DISEASE CONTROL AND PREVENTION
FISCAL
YEAR 2001 DHHS LEGISLATIVE PROPOSAL
National Program of Cancer Registries
Expand the type of organizations eligible to operate State cancer registries.
Current Law: Section 399H of the Public Health Service Act establishes within CDC a national program of cancer registries, and authorizes grants to States to support the operation of the registries. Also, in lieu of making a grant to the State, the law allows for grants or contracts with academic or nonprofit organizations designated by the State to operate the State's registry. The law does not permit grants or contracts with other entities, such as private, for-profit organizations.
Proposal: Remove the restriction that States may designate only academic or nonprofit organizations to operate the States' cancer registries.
Rationale: By allowing only academic or nonprofit organizations to operate the State's registry, the law unnecessarily and unfairly limits the States' options and undercuts their ability to choose the best servicing agent for the registry. In certain cases, States may not have an academic or non-profit organization with the necessary expertise, infrastructure or interest in serving as the designee for cancer registries. In some states, although adequate academics and non-profits may exist, the best choice may be a private, for-profit facility because of the expertise and resources already available to that organization. A large for-profit cancer center, for example, may diagnose and treat the majority of cancer cases in a State and would be the State’s logical designee to operate the cancer registry, yet would be ineligible to play this role because of current federal law. It is important to expand eligibility criteria to include such organizations, permitting States the flexibility to select the best choice for this program. No proprietary or data confidentiality issues have surfaced or are anticipated. Any data ownership issue would be addressed specifically in the agreement between the State and its designees. CDC will provide technical assistance to support the States in this effort.
Cost: None.
CDC-1999/03
1/19/99
CENTERS FOR DISEASE CONTROL AND PREVENTION
FISCAL
YEAR 2001 DHHS LEGISLATIVE PROPOSAL
Reauthorize STD-Related Infertility Program
Reauthorize the Infertility and Sexually-Transmitted Disease Program.
Current Law: Section 318A of the Public Health Service Act authorizes activities related to screening, treatment, counseling, and follow-up services related to sexually transmitted diseases (STD) that can cause infertility in women if treatment is not received for the disease.
Proposal: Reauthorize appropriations for the STD-related infertility program for five years.
Rationale: Reauthorization of this program is essential to ensure the continuation of critical STD-related infertility prevention services. STDs are hidden epidemics of tremendous health and economic consequences in the United States. Women and infants bear a disproportionate burden of STD-associated complications. A variety of women’s health problems, including infertility, ectopic pregnancy, and chronic pelvic pain result from unrecognized or untreated STDs.
The STD chlamydia is the most frequently reported infectious disease in the United States (an annual incidence of 4 million cases). When undiagnosed, chlamydia can cause severe, costly reproductive and other health problems. These include both short-and long-term consequences, such as pelvic inflammatory disease (PID), which is the critical link to infertility, and potentially fatal tubal pregnancy. Up to 40% of women with untreated chlamydia will develop PID. Of those with PID, 20% will become infertile. Chlamydia also results in other adverse outcomes. When diagnosed, chlamydia can be easily treated and cured. Conservatively, the reproductive consequences in women result in an estimated annual cost of chlamydia infection in the U.S. of $2.4 billion, $1.7 billion of which is attributable to treatment of preventable, serious after effects in women.
Authorization Level: Such sums as necessary
CDC-1999/03A
1/6/99
CENTERS FOR DISEASE CONTROL AND PREVENTION
FISCAL
YEAR 2001 DHHS LEGISLATIVE PROPOSAL
Infertility/STDs – Male Inclusion
Expand the sexually transmitted disease-related infertility program to include males who are not sexual partners of women screened in the program.
Current Law: Section 318A of the Public Health Service Act authorizes a program to address any treatable sexually transmitted disease that can cause infertility in women if treatment is not received for the disease. The activities authorized under the section pertain only to women and their sexual partners.
Proposal: Allow grantees of 318A funding to screen and treat for chlamydia men who are not sexual partners of women served by the program, as long as screening coverage levels in women are not reduced.
Rationale: The intent of Section 318A is to prevent STD-related infertility in women. However, the existing statute undercuts efforts to achieve this overall objective by authorizing related intervention only for females and for males who are sexual partners of women served under the program -- not for other males who may be at risk. Amending the statute to permit grantees to provide intervention activities for males who are not sexual partners would rectify the limitations of the current law. The progress being made against STD-related infertility in women soon will plateau unless previous activities are directed to men more broadly.
Several studies have demonstrated that chlamydia is common among young men and that up to 50% of infected men have no symptoms. The recent availability of highly accurate urine tests for chlamydia now make screening males a feasible intervention to reduce asymptomatic disease in men and importantly, to reduce transmission to women. Studies have documented a 50% male to female transmission rate; that is, one of every two encounters with an infected male results in an infected female. Because the STD-infertility programs have focused on prevention efforts in women, many men with chlamydia are not diagnosed and treated, thus continuing the cycle of infection. Untreated chlamydia in men typically causes urethral infection, but may also result in other complications.
Cost: No funds requested.
CDC-1999/03B
1/19/99
CENTERS FOR DISEASE CONTROL AND PREVENTION
FISCAL
YEAR 2001 DHHS LEGISLATIVE PROPOSAL
Infertility/STDs -- Treatment Training
Authorize training about treatment for sexually transmitted disease-related infertility.
Current Law: Section 318A of the Public Health Service Act authorizes activities related to screening, treatment, counseling, and follow-up services related to sexually transmitted diseases that can cause infertility in women if treatment is not received for the disease. The law also authorizes providing training to health care providers in carrying out screening and counseling, but the law is silent regarding the provision of training for health care providers about appropriate treatment.
Proposal: Revise the law to authorize training for health care providers about appropriate treatment for STD-related infertility.
Rationale: Training health care professionals only about screening and counseling for STD- related fertility is inadequate. Including treatment as part of training programs in the medical community is an essential activity.
Expending resources and providing training on screening and counseling activities is pointless if adequate and timely treatment of both infected individuals and their sexual partner does not occur. Once diagnosed, proper treatment is key to controlling further disease transmission, and for women, to averting long-term sequelae. Several surveys of prescribing practices of providers have demonstrated that as many 25% do not use correct anti-microbial therapies, highlighting the need for continued training on appropriate treatment for these common infections. The CDC regularly publishes recommended treatment regimens for all STDs.
Lower genital tract chlamydial and gonococcal infections are easily cured by early and prompt treatment with a short course or single dose of specific antibiotics. However, if not adequately treated, up to 40 % of women infected with chlamydia and gonorrhea develop upper genital tract infections, also called pelvic inflammatory disease (PID). PID is the leading cause of STD- related infertility in women.
Cost: None
CDC-1999/03C
1/19/99
CENTERS FOR DISEASE CONTROL AND PREVENTION
FISCAL
YEAR 2001 DHHS LEGISLATIVE PROPOSAL
Infertility/STDs -- Grant Cycle
Revise the grant cycle limitation for the STD-related infertility grant program.
Current Law: Section 318A of the Public Health Service Act authorizes a program of grants to States to address STD-related infertility in women. The law stipulates that grants made under this program may not exceed three years.
Proposal: Revise the statute to eliminate the three-year limitation on the grant.
Rationale: In numerous other State grant programs CDC administers, grants generally are awarded for a period of up to five years, not three. Additionally, in many other cases, the permissible duration of the grant is not specified in statute. For example, the general grant program for STD prevention authorized under Section 318 of the Public Health Service Act does not stipulate a three-year limitation on funds awarded, whereas Section 318A (STD-related infertility) does have such a limitation. From both a program planning and administrative perspective, it is desirable to allow for corresponding grant cycles for the STD and STD-related infertility grant programs.
Cost: No additional costs.
CDC-2000/01
4/20/99
CENTERS FOR DISEASE CONTROL AND PREVENTION
FISCAL
YEAR 2001 DHHS LEGISLATIVE PROPOSAL
Reauthorization of the Preventive Health and Health Services Block Grant
Reauthorize the Preventive Health and Health Services Block Grant for an Additional Five Years
Current law: Title XIX, Section 1901 of the Public Health Service Act establishes CDC’s Preventive Health and Health Services Block Grant.
Proposal: Extend the current authorization for an additional five years.
Rationale: The CDC-administered Preventive Health and Health Services Block Grant is a model partnership between the Centers for Disease Control and Prevention, local communities, and state health departments. This mechanism allows CDC to target funds to important public health issues based on the health priorities of local communities and in consultation with state health departments which assure accountability for the funds spent. It is the leading source of funds for injury prevention, dental health, and emergency medical services. The Block Grant program also serves as the primary source of Federal funding to States for health education and risk reduction activities, cholesterol and hypertension screening, cancer prevention, and sex offenses prevention programs. The flexibility of this program allows for targeted, strategic efforts to address specific health problems at the local in a collaborative manner
Authorization Level: Such sums as necessary
Personnel Requirements: 32 FTE
CDC-2000/02
1/18/00
CENTERS FOR DISEASE CONTROL AND PREVENTION
FISCAL
YEAR 2001 DHHS LEGISLATIVE PROPOSAL
Preventing Prostate Cancer
Reauthorize the Preventive Health Measures with Respect to Prostate Cancer.
Current Law: Section 317D of the Public Health Service Act establishes the CDC’s Preventive Health Measures with Respect to Prostate Cancer.
Proposal: Extend the current authorization for an additional five years.
Rationale: Prostate cancer is most common among men aged 65 years and older. Men in this age group account for about 80 percent of clinically diagnosed prostate cancers. From 1973 to 1992 the incidence of prostate cancer in the United States increased from 64 to 187 per 100,000 persons and the death rates rose by nearly 23%. Increased screening and detection have likely contributed to the recent rise in the incidence of prostate cancer. The American Cancer Society (ACS) estimates that more than 179,300 new cases of prostate cancer will be diagnosed in 1999. Further, it is estimated that 37, 000 men will die of this disease in 1999. Prostate cancer mortality rates are more than 2 times higher among African-American men than white men.
Preventable risk factors for prostate cancer are unknown, and effective measures to prevent the occurrence of this disease do not currently exist. Although one proposed method to reduce the risk of death from prostate cancer is through screening and early detection, health professionals have not come to a consensus on early detection guidelines. Scientific evidence has been insufficient to determine if screening for prostate cancer reduces mortality or if treatment of early disease is more effective than no treatment in prolonging a patient’s life. Currently health practitioners cannot accurately determine which cancers will progress to become clinically significant and which will not. Thus, widespread screening and testing for early detection of prostate cancer is not scientifically justified at this time.
CDC’s efforts regarding prostate cancer focus on assessing the knowledge, attitudes, and practices of men and their physicians regarding prostate cancer screening and treatment that is crucial to designing early detection programs. In addition, funding directed to CDC through the President’s Initiative to Eliminate Racial and Ethnic Disparities in Health currently supports projects in surveillance, prevention research, and education to answer important questions about the epidemiology of prostate cancer and the effectiveness of prostate cancer testing and to develop and disseminate appropriate messages to enable the public, physicians, health departments, policy makers and others to make informed decisions regarding prostate cancer screening and follow-up. These activities are designed to begin to build the science-base on prostate cancer and establish scientifically sound methods of prevention, detection and treatment.
Authorization Level: For FY 2001, $9.2* million; for FY 2002-2005, such sums as necessary.
* CDC has not received appropriations to implement the provisions of this legislative authority. Consequently, amounts budgeted for prostate cancer for FY 2001 do not contain funding for this authority.
CDC-2000/04B
CENTERS FOR DISEASE CONTROL AND PREVENTION
FISCAL
YEAR 2001 DHHS LEGISLATIVE PROPOSAL
Confidentiality Law Enforcement Mechanism
Add Enforcement Mechanism to Strengthen Current National Center for Health Statistics’ Confidentiality Law
Current Law: Section 308(d) of the Public Health Service Act states that identifiable information obtained by NCHS may be used only for the purposes for which it was supplied unless otherwise agreed to by the person or establishment providing the information and that the information may not be released in other form if it is identifiable unless the person or establishment providing the information has agreed to the release. However, Section 308(d) does not include any provision for penalties for offenders of this provision.
Proposal: Add an explicit penalty clause to Section 308(d) of the Public Health Service Act, to make breach of confidentiality an enforceable offense under the statute, similar to those applicable penalties under the Health Care Quality and Improvement Act of section 427(b)(2).
Rationale: Providing an enforcement mechanism for the existing confidentiality clause will further protect the privacy and confidentiality of information exchanged between NCHS and its partners. While Section 308(d) includes strong requirements for maintaining the confidentiality of data obtained by NCHS, it does not include penalties to enforce them. The public, including survey respondents, has become increasingly concerned about protecting the privacy of sensitive medical information. Adding penalty provisions to Section 308(d) would demonstrate NCHS’ continuing commitment to protecting personal information and further reassure respondents of the high priority placed on maintaining confidentiality.
Cost: None
CDC-2000/05
1/18/00
CENTERS FOR DISEASE CONTROL AND PREVENTION
FISCAL
YEAR 2001 DHHS LEGISLATIVE PROPOSAL
Sexually Transmitted Disease Programs
Extend authorization of appropriations for grants for research, training and public health programs for the prevention of sexually transmitted diseases.
Current Law: Grants for sexually transmitted disease programs are authorized under section 318 of the Public Health Service Act.
Proposal: Reauthorize appropriations to carry out this program for five additional years.
Rationale: CDC’s STD Prevention Program provides national and international leadership through research, policy development, and support of effective services to prevent and control the transmission of STDs and their complications, such as enhanced HIV transmission, infertility, adverse outcomes of pregnancy, and reproductive tract cancer. CDC provides resources and other program support to all 50 states, 6 cities, the District of Columbia, Puerto Rico, Virgin Islands, and 6 Pacific Island Nations or Territories.
STDs remain among the most critical public health challenges facing the United States today, not only because they are the most frequently reported communicable diseases in the country, but because they cause largely preventable, severe, and costly complications in America’s most vulnerable populations. STDs cause severe consequences for women and infants (especially ethnic and racial minority populations). Their high rates in adolescents and young adults create a heavy disease burden in this group – and STDs facilitate the sexual transmission of human immunodeficiency virus (HIV). The challenge in solving this immense problem centers on overcoming barriers to healthy sexual behaviors in society at large while also delivering comprehensive, effective, essential STD services in innovative ways to high risk individuals at the community level.
Authorization level: For FY 2001, $118.4 million*; for FY 2002-2005, such sums as necessary.
*Excludes $18.2 million for STD-related infertility prevention authorized under PHS Act Section 318A.
CDC-2000/08
1/14/00
CENTERS FOR DISEASE CONTROL AND PREVENTION
FISCAL
YEAR 2001 DHHS LEGISLATIVE PROPOSAL
Injury Research and Control Program
Reauthorize the Injury Research and Control Program.
Current Law: Section 394(A) of the Public Health Service Act, as redesignated by Section 201(I) of Public Law 103-183, provides authorizations for Section 391, 392, 393, and 394 of that Act through Fiscal Year 1998.
Proposal: Extend the current authorization for an additional five years.
Rationale: Each year over 150,000 Americans die from injuries, and one in three persons suffers a nonfatal injury. Injury is the leading cause of death for Americans, ages 1-44, impacting disproportionately on children, youth, and young adults. It accounts for the deaths of 60 of America’s children every day, which translates to almost three children every hour. Injury now joins the ranks of heart attacks, strokes, and cancer as a major cause of death among seniors. Falls represent the principal cause of death for seniors over age 75. Each year over 5,000 women are murdered in the U.S., and violence kills more youth than any other cause, except for motor vehicle crashes; for African American youth, violence-related injury is the leading cause of death.
Injuries are one of our most expensive health problems, with a lifetime cost estimated at $224 billion. Many of those costs are incurred by the more than 80,000 people in the U.S. who are unnecessarily, but permanently, disabled from brain or spinal cord injury.
CDC’s Injury Research and Control Program is designed to create the system through which we can identify problem areas and emerging issues and monitor progress (surveillance); conduct the research necessary for finding effective solutions; and deliver injury prevention and control interventions and information to people at risk and to the public and private partners who can help lower injury rates.
Authorization Level: For FY 2001, $86.2 million; for FY 2002-2005, such sums as necessary.
CDC-2000/09
1/18/00
CENTERS FOR DISEASE CONTROL AND PREVENTION
FISCAL
YEAR 2001 DHHS LEGISLATIVE PROPOSAL
TBI Research and Reporting
Reauthorize monitoring of incidence and prevalence of traumatic brain injury for an additional five years.
Current Law: Section 4 (a) and (d) of P.L. 104-166 provides appropriations for the Secretary of DHHS, acting through the Public Health Service, to conduct among other things, a study to determine the incidence and prevalence of traumatic brain injury (TBI) and to develop a uniform reproting system under which states report incidents of TBI..
Proposal: Extend authorization for activities to determine incidence and prevalence of traumatic brain injury and to develop a uniform reporting system under which States report incidents of traumatic brain injury.
Rationale: CDC has collected and evaluated state data showing the incidence of TBI, using the 15-state uniform reporting system developed with the funds provided, and prepared a report of its findings for submission to the Congress, as required by Section 4(a). Now that the system has been developed, there is an ongoing need to continue the collection of accurate surveillance data in order to monitor the magnitude and severity of TBI in states and how these factors change over time; to identify risk factors; and to determine which interventions are effective in preventing or reducing the incidence or severity of TBI and TBI-related disabilities.
The proposed reauthorization would support continued monitoring of the incidence and prevalence of TBI. It would also support the continued development and support of a State-based reporting system for TBI. The need for such activities did not end with the completion of the study initially authorized by P.L. 104-166. Surveillance is a necessary element in the development of interventions to prevent or reduce the impact of TBI and TBI-related disabilities. Through the study, CDC set up the mechanism by which surveillance activities can become an integral and ongoing component of the activities envisioned in Section 1 of Public Law 104-166. CDC will continue to publish data from this surveillance system on a periodic basis.
There would be no effect on the roles, rights, or responsibilities of states; nor would any kind of unfunded mandate be imposed upon states. CDC provides expertise, leadership, and coordination to assist state and local governments in implementing effective community injury prevention programs and to assist them in using scarce funds most efficiently. In this effort, we work in partnership with the public and private sectors.
Authorization level: For FY 2001, $3 million; for FY 2002-2--5, such sums as necessary.
CDC-2001/03
1/18/00
CENTERS FOR DISEASE CONTROL AND PREVENTION
FISCAL
YEAR 2000 DHHS LEGISLATIVE PROPOSAL
Preventing Sexual Assault Against Women
Reauthorize appropriations for grants to states to carry out rape prevention and education efforts.
Current Law: Section 40151 of Public Law 103-322 (42 U.S.C. 300w-10) authorizes grants to states for rape prevention education programs (the Assistance to Victims of Sexual Assault program). This section is included as footnote to Section 1910A(a)(c) of the Public Health Service Act due to a reference error in P.L.103-322.
Proposal: Reauthorize expiring authorizations of appropriations to carry out this program.
Rationale: The Violent Crime Control and Law Enforcement Act of 1994 (P.L 103-322), which originally authorized this program, provided for appropriations in the amount of $35 million for fiscal years 1996 and 1997 and $45 million for fiscal years 1998-2000. Funding is granted to States to conduct rape prevention education.
These grants have increased the ability of states to prevent and respond to sexual assault in a number of ways. They have provided State health departments the opportunity to add needed staff to oversee the development and implementation of statewide sexual assault prevention activities. They have enabled greater collaboration between sexual assault coalitions and health departments by bringing together expertise from each. For example, several state sexual assault coalitions and health departments are developing and implementing innovative methodology to evaluate their sexual assault prevention activities.
This funding has also provided for development and expansion of hotlines. It has provided for opportunities to collect data that will increase knowledge in these areas and enhance prevention programs and services. Further, states have used the rape prevention and education funds to reach more students and to improve the quality of educational materials. For the first time, many sexual assault coalitions have been able to mount statewide public awareness campaigns to educate the public about sexual assault and services available to victims of sexual assault. Without this funding, these accomplishments will be difficult, if not impossible, to maintain.
Authorization level: For FY 2001, $45 million; for FY 2002-5, such sums as necessary.
Personnel Requirements: Currently 7 FTEs; no growth expected.
FDA-2000/01
FOOD AND DRUG ADMINISTRATION
FISCAL YEAR 2001 DHHS
LEGISLATIVE PROPOSAL
Repeal Imported Milk Act
Repeal the Import Milk Act and Achieve Consistency with the World Trade Organization Agreement
Current Law: The Import Milk Act (IMA) (P.L. 69-625) was enacted in 1927 for the stated purpose “To regulate the importation of milk and cream into the United States for the purpose of promoting the dairy industry of the United States and protecting the public health.” The most significant requirement is the need for importers to have a valid permit issued by the Secretary in order to ship milk or cream into the United States. Among other things, the law considers milk unfit if the producing cows are not healthy and if they have not been examined within the past year, and if the farm has not passed a sanitary inspection within the past year.
Proposal: Repeal the Import Milk Act, Public Law 69-625.
Rationale: There is no need for the IMA as the Federal Food, Drug and Cosmetic Act and the Public Health Service Act provide adequate control measures for dairy products. The health protection of the IMA have been superseded by the National Conference of Interstate Milk Shipments, which is overseen by the FDA under provisions of the PHS Act.
The IMA is inconsistent with the World Trade Organization Agreement and under the agreement needs to be repealed by 1999. Failure to repeal puts the United States at risk for a complaint to the WTO. Enforcement of the IMA also would contradict the subsidies and market access provisions of the North American Free Trade Agreement.
Repeal of the IMA has been recommended by the United States Trade Representative’s office.
Cost: Repeal of the IMA is budget neutral.
BHPr-2000/02
9/15/98
HEALTH RESOURCES AND SERVICES ADMINISTRATION
FISCAL
YEAR 2001 DHHS LEGISLATIVE PROPOSAL
National Vaccine Injury Compensation Program:
Allow
the Payment of Family Counseling Expenses
Allow for the inclusion of family counseling expenses in awards under the National Vaccine Injury Compensation Program (VICP)
Current Law: Section 2115(a) of the Public Health Service Act sets out the compensation which may be awarded under the Program to a petitioner for a vaccine-related injury or death. Awards may include payments for unreimbursable expenses for rehabilitation, developmental evaluation, special counseling, emotional or behavioral therapy, residential and custodial care and service expenses, special equipment, related travel expenses, and facilities. Compensation may not be for anything not included in this list unless it is specifically for the health, education, or welfare of the person who suffered the vaccine-related injury.
Proposal: Add payment of costs associated with family counseling to subsection (a) under (1)(A)(iii)(II) making compensation for such costs allowable.
Rationale: In its current form, the statute does not specifically allow for amounts to be awarded for purposes other than the immediate needs of the injured party. The Act does allow for counseling for the injured party as part of that person’s overall rehabilitation and development. The proposed change recognizes the importance of the family to the overall well-being of the injured party and allows for the award of expenses needed to help all family members cope with the aftermath of such a devastating event. Emotional conflicts among parents and siblings can irreparably damage relationships which are necessary to support and nurture the injured party. In such cases, expenses for counseling, which will ensure the best possible family environment for the injured party, are absolutely appropriate as they are expenses specifically related to the vaccine injury and are for the specific benefit of the injured party. Existing language in Section 2115 providing that expenses must be related to the vaccine injury and incurred on behalf of the injured person will still require that petitioners demonstrate that family counseling is reasonably necessary for the care of the vaccine-injured person, keeping with the intent of the statute. This amendment will make it easier to demonstrate the reasonableness of, and necessity for an award of compensation for family counseling expenses.
The Advisory Commission on Childhood Vaccines (ACCV) is mandated to advise and make recommendations to the Secretary of Health and Human Services on issues relating to the operation of the VICP. The ACCV voted unanimously to recommend that the Secretary propose legislation which would allow compensation awards to include amounts for family counseling.
Effect on Beneficiaries: This change will improve the family relationships of vaccine-injured persons (mostly children) in family situations where counseling is needed.
Cost: The provision of counseling for other members of the injured party’s family is necessary in about 75 percent of the injury cases awarded each year. The annual number of awards is approximately 50 per year. The estimated average amount required for family counseling is $6,000 resulting in an annual estimate of $198,000.
(Dollars in Millions)
FY 2001-2005
$0.2
Other Data: Add the phrase “(including family counseling)” to Section 2115(a)(1)(A)(iii)(II) so that it will then read;
“(iii)(II) have been or will be for rehabilitation, developmental evaluation, special education, vocational training and placement, case management services, counseling (including family counseling), emotional or behavioral therapy, residential and custodial care and service expenses, special equipment, related travel expenses, and facilities determined to be reasonably necessary.”
BHPr-2000/03
9/15/98
HEALTH RESOURCES AND SERVICES ADMINISTRATION
FISCAL
YEAR 2001 DHHS LEGISLATIVE PROPOSAL
National Vaccine Injury Compensation Program:
Clarify
the Scope of “Factors Unrelated”
Clarify the Scope of the term “Factors Unrelated” as it applies to determining eligibility and compensation.
Current Law: Section 2113(a) of the Public Health Service Act (the Act) sets out the eligibility and compensation requirements of the National Vaccine Injury Compensation Program (VICP). Subsection(a)(1) specifies that compensation shall be awarded if the Special Master or the Court finds on the record as a whole that the illness, disability, injury, condition, or death described in the petition is not due to factors unrelated to the administration of the vaccine described in the petition. Subsection (a)(2) defines the term “factors unrelated to the administration of the vaccine”. This term does not include any idiopathic, unexplained, unknown, hypothetical or undocumentable cause, factor, injury, illness, or condition, and may include infection, toxins, trauma (including birth trauma and related anoxia), or metabolic disturbances which have no known relation to the vaccine involved, but which in the particular case are shown to have been the agent or agents principally responsible for causing the petitioner’s illness, disability, injury, condition, or death.
Proposal: Add genetic disorders and structural lesions to the list of factors identified in Subsection (2)(B) as potential “factors unrelated,” and state that these as well as the currently listed elements may be factors unrelated without regard to whether their cause is known.
Rationale: In order to award compensation, the Act provides that the Court must find by a preponderance of the evidence that the injury in question was not due to “factors unrelated” to the vaccine. Under existing statutory language, infection, toxins, trauma or metabolic disturbances which have no known relation to the vaccine but which are considered the principal cause of the claimed injury may be considered a “factor unrelated” to the immunization and serve as a basis to deny compensation. However, a factor unrelated cannot be an “idiopathic, unexplained, unknown, hypothetical or undocumentable cause, factor , injury, illness, or condition.” In several cases, the court has broadly interpreted this provision in holding that if the cause of the claimed injury is “idiopathic,” or unknown, it cannot be a “factor unrelated” even if it is a well-defined condition and known to be unrelated to immunization.
A statutory amendment is necessary to effectuate Congressional intent that compensation should not be afforded if the claimed injury is due to an alternative cause and not the vaccine. Such an amendment would reflect accurate medical science concerning what constitutes “factors unrelated” or alternative cause. Certain well-defined medical conditions, such as genetic disorders or structural lesions (malformations of the brain secondary to developmental abnormalities during fetal brain development), that are unrelated to immunization and are the known cause of a claimant’s condition should qualify as “factors unrelated” even if the cause of the alternative cause is unknown. Such a defined alternative cause is not “idiopathic” and should not be disregarded simply because the “cause of the cause” is unknown. In other words, when the vaccine has no known relation to the alternative cause, the alternative cause constitutes a factor unrelated, even if the precise cause of the alternative cause is unknown. With the current state of the decisional law, conditions which are clearly not vaccine related have been compensated, placing the medical integrity of the Program in question.
Additionally, the injury “encephalopathy” was redefined in the February 1995 regulations to clarify that an encephalopathy caused by infection, toxin, trauma, metabolic disturbance, structural lesion or genetic disorder, shall not be considered a Table condition without regard to whether the cause of such condition is known. 42 C.F.R.§100.3(b)(2)(iii). For consistency, a similar clarification of what constitutes a compensable injury should be made applicable to all listed Table injuries. By redefining the term “factor unrelated” consistent with the clarification in the new regulations for encephalopathy, no longer will compensation be paid for injuries that are clearly not vaccine related. When an alternative cause is the known reason for an individual’s condition, vaccine compensation should not be paid, even though the cause of the alternative cause is unknown.
The Advisory Commission on Childhood Vaccines (ACCV) is mandated to advise and make recommendations to the Secretary of Health and Human Services on issues relating to the operation of the VICP. By a vote of 5 to 2 the ACCV voted to recommend that the Secretary propose legislation which would add genetic disorders and structural lesions to the list of things which are clearly not related to the administration of vaccines.
Effect on Beneficiaries: This change will make it more likely that awards will be granted only to individuals with true vaccine injuries.
Cost: This change will result in the award of about 2 cases less each year. Average award amounts total approximately $1 million for each case. Savings from this change will amount to around $2 million per year.
(Dollars in Millions)
| FY 1998 | FY 1999 | FY 2000 |
| ($2.0) | ($2.0) | ($2.0) |
Other Data: Section 2113(a)(2)(B) would appear as follows:
“(B) may, as documented by the petitioner’s evidence or other
material in the record, include infection, toxins, trauma (including birth
trauma and related anoxia), structural lesions, genetic disorders, or
metabolic disturbances, without regard to whether the cause of the
infection, toxin, trauma, structural lesion, genetic disorder or metabolic
disturbance is known, but which have no known relation to the vaccine
involved, but and which in the particular case are shown to have
been the agent or agents principally responsible for causing the
petitioner’s illness, disability, injury, condition, or death.”
BHPr-2000/04
9/15/98
HEALTH RESOURCES AND SERVICES ADMINISTRATION
FISCAL
YEAR 2001 DHHS LEGISLATIVE PROPOSAL
National Vaccine Injury Compensation Program:
Allow
Interim Payment of Costs
Authorize interim payment of costs incurred in adjudicating a post-1988 claim under the Program after a finding of entitlement is established.
Current Law: Section 2115 of the Public Health Service Act sets out the compensation which may be awarded at the conclusion of a vaccine-related injury or death case. Subsection (e) allows for compensation of “reasonable attorneys’ fees” and “other costs”. Because the payment of attorneys’ fees and other costs is included in the compensation awarded at the conclusion of the proceeding, petitioners and their attorneys must pay all costs of filing and presenting their cases out of pocket. As it is currently constructed, the Act does not allow for compensation to attorneys or petitioners for those expenditures required to gather, present, and support their case, prior to the final decision by the Special Master even though attorneys fees and costs ultimately may be paid regardless of the final decision as to whether entitlement is established.
Proposal: Add language to Section 2115 of the Public Health Service Act which would make available to petitioner, even though attorneys fees and costs may be paid regardless of the final decision as to whether entitlement is established, subsequent to a finding of entitlement in any case involving a vaccine administered on or after October 1, 1988, payment of actual costs involved in filing and adjudicating the claim up to the time that such a finding is made. The language would also include a requirement that the payment be based on submission of documentation verifying the expenditure of the amount requested, and that the payment may only be used for those costs allowed under 2115(e)(1)(B) “Other Costs”.
Rationale: In the process of filing a petition for compensation based on a suspected vaccine- related injury, the petitioner is often required to personally pay costs related to filing, such as expert witness costs and duplication of medical record costs. In those cases where a petitioner lacks the resources to pay such costs, the case might not be brought unless the petitioner is able to find an attorney who is willing to front those costs for the petitioner, and then carry that debt until the case is concluded. There is evidence that, on occasion, this may inhibit petitioner’s ability to obtain legal representation and medical expert witness testimony under the Program. Often, petitioners must provide payment for the up-front costs incurred in filing a claim under the Program, straining already tenuous financial situations. To reduce the hardship on petitioners under the Program and to expand the opportunity for all eligible parties to participate in the Program, this amendment would allow for the payment of actual costs (excluding attorneys’ fees) incurred in developing and documenting a vaccine-injury compensation case, much earlier in the process, i.e., at the time the initial determination of entitlement is made.
The Advisory Commission on Childhood Vaccines (ACCV) is mandated to advise and make recommendations to the Secretary of Health and Human Services on issues relating to the operation of the VICP. The ACCV voted unanimously to recommend that the Secretary propose legislation which would allow for the interim payment of costs.
Effect on Beneficiaries: This change will ease financial burdens currently borne by all petitioners and will be especially beneficial to financially disadvantaged petitioners.
Cost: There is no change in costs associated with this amendment.
Other Data: Add a new subsection to Section 2115(e) as follows:
“(4) Subsequent to a finding of entitlement in any case involving a vaccine administered on or after October 1, 1988, an award of compensation may be made to petitioner limited to actual costs incurred in proceeding on the petition (as defined under paragraph (1)(B), “other costs”), so long as petitioner provides documentation verifying the expenditure of the amount requested.”
BHPr-2000/05
9/15/98
HEALTH RESOURCES AND SERVICES ADMINISTRATION
FISCAL
YEAR 2001 DHHS LEGISLATIVE PROPOSAL
National Vaccine Injury Compensation Program:
Allow
the Payment of Guardianship Expenses
Allow for the payment of fees and costs associated with the establishment of guardianships.
Current Law: Section 2115(e) of the Public Health Service Act (the Act) sets out the compensation which may be awarded to pay for “reasonable attorneys’ fees” and “other costs”. Subsection 2115(e)(1)(B) allows for payment of other costs, but does not provide specific guidance on what may be included in these costs.
Proposal: Add a phrase which would specifically allow for the inclusion of reasonable fees and costs associated with the establishment of a guardianship or conservatorship in the definition of “other costs.”
Rationale: In its current form, the Act does not specifically allow for costs to be reimbursed for the establishment of a guardianship to oversee the use of funds awarded for the treatment and care of injured individuals. In fact, prevailing case law has reinforced that the statute does not allow compensation for such expenses. See Siegfried v. Secretary, HHS, 19 Cl.Ct. 323, 325 (1990); and Hulsey v. Secretary, HHS, 19 Cl. Ct. 331, 334 (1990). However, there have been cases which supported the opinion that such expenses should be compensable and have in fact awarded guardianship costs as in Thomas v. Secretary, HHS, No. 92-46V, 1997 WL 74664, at 3 (Fed. Cl. Spec. Mstr. Feb. 3, 1997).
Provisions for guardianships/conservatorships are routinely included in settlement stipulations because they are usually required by life insurance companies, and because it protects the integrity of the Program by protecting the award granted to the vaccine-injured individual (who is often legally incompetent). As with other attorneys’ fees and costs payable under the Program, permissible guardianship expenses will be limited to those that have already been incurred and documented as part of petitioners’ application of attorneys’ fees and costs. Fees associated with the future maintenance of a guardianship account would not be included.
The Advisory Commission on Childhood Vaccines (ACCV) is mandated to advise and make recommendations to the Secretary of Health and Human Services on issues relating to the operation of the VICP. The ACCV voted unanimously to recommend that the Secretary propose legislation which would add the payment of costs associated with the establishment of guardianships to the list of “other costs” which may be paid under Section 2115(e)(1)(B) of the Act.
Effect on Beneficiaries: This change will enhance the protection of awards granted to injured individuals.
Cost: The average cost of establishing a guardianship is approximately $2,000 and guardianships are established in about 50 cases each year.
(Dollars in Millions)
| FY 1998 | FY 1999 | FY 2000 |
| $0.1 | $0.1 | $0.1 |
Other Data: Change Section 2115(e)(1)(B) to read as follows:
“ (B) other costs, incurred in any proceeding on such petition, including reasonable fees and costs associated with the establishment of a guardianship or conservatorship. If the judgement of a Special Master...”
BHPr-2000/07
9/15/98
HEALTH RESOURCES AND SERVICES ADMINISTRATION
FISCAL
YEAR 2001 DHHS LEGISLATIVE PROPOSAL
National Vaccine Injury Compensation Program:
Clarify
the Calculation of Lost Earnings
Identifies a specific basis for calculating projected lost earnings resulting from a vaccine-related injury.
Current Law: Section 2115(a) of the Public Health Service Act sets out the compensation which may be awarded under the Program to a petitioner for a vaccine-related injury or death. Subsection (3)(B) specifies that if a person has sustained a vaccine-related injury before reaching the age of 18 and has an impaired earning capacity because of that injury which is likely to continue beyond age 18, compensation after attaining the age of 18 for loss of earnings will be determined on the basis of the average gross weekly earnings of workers in the private non-farm sector less appropriate taxes and the average cost of a health insurance policy, as determined by the Secretary of Health and Human Services (HHS).
Proposal: Specify in Section 2115(a)(3)(B) of the statute the use of the figure tabulated by the Bureau of Labor Statistics (BLS) from the Current Population Survey (CPS) based on specifications designed by the Department of Justice (DOJ) in consultation with a team of economic experts to best reflect the statutory criteria. This figure would be calculated annually at the request of the Secretary of HHS for use in the calculation of lost earnings under the VICP.
Rationale: The proposed amendment would codify the method of calculation that is currently in use by the government in vaccine cases. The current statutory language does not specify how average gross weekly earnings of workers in the private, non-farm sector are to be calculated in cases where an individual sustains a vaccine injury prior to age 18 which impairs his or her earning capacity. Until recently, projected lost earnings in such cases were determined based on a Bureau of Labor Statistics (BLS) figure published in the Current Employment Statistics (CES), which computes “the average weekly earnings of production or nonsupervisory workers on private non-farm payrolls”. This figure does not include statistics for supervisory workers, a fact which became the subject of legal challenges recently in several cases. As a result, DOJ requested that BLS prepare a special tabulation from data contained in another wage series known as the Current Population Survey (CPS). After consulting with a group of labor economists, the Department requested that this tabulation reflect the average gross weekly earnings of all workers in the private, non-farm sector, including supervisory and nonsupervisory workers, as well as part-year and part-time workers and full-year, full-time workers, and exclude the self-employed. This new calculation more accurately reflects the average weekly earnings of the group identified in the statute (the private, non-farm sector) than the CES figure, and is now being used by the government in pending vaccine cases to determine average gross weekly wages. Annual earnings data is calculated from the CPS in the first quarter of every year and BLS has agreed to provide an update of the special tabulation to the Secretary annually.
In keeping with the purpose of the Program, as stated in House Report No. 99-908, to provide compensation with certainty and generosity, it is appropriate to apply the special tabulation when calculating potential lost earnings. Codifying the use of this specific calculation would add certainty to the process of compensating injured persons while providing a more generous payment for lost earnings. In the past, the calculation did not include the salaries of supervisory personnel, and was therefore skewed to a lower level. This lower level of compensation has been challenged on the grounds that it unfairly assumes that none of these injured persons would attain a level of supervisory responsibility and the commensurate higher salary.
The Advisory Commission on Childhood Vaccines (ACCV) is mandated to advise and make recommendations to the Secretary of Health and Human Services on issues relating to the operation of the VICP. The ACCV voted unanimously to recommend that the Secretary propose legislation which would establish a specific basis for the calculation of projected lost earnings from a vaccine-related injury.
Effect on Beneficiaries: Codifying the use of this calculation will not affect beneficiaries.
Cost: Enactment of this amendment will not increase Program costs because the method to be codified is the method currently in use. By standardizing the calculation, costs associated with litigation based on the lost earnings calculation method will be reduced. Each year about ten challenges are filed to the method used in calculating lost earnings. These cost about $2,000 each including attorney and financial expert costs. Costs to the VICP total approximately $20,000 per year which would be saved by standardizing the calculation method.
Other Data: Amend Section 2115(a)(3)(B) to include a specific description of the calculation used in arriving at an average weekly gross earnings figure so that it will then read:
“...for loss of earnings determined on the basis of the annual estimate of the average (mean) gross weekly earnings of wage and salary workers age 18 and over (excluding the incorporated self employed) in the private non-farm sector (which includes all industries other than agricultural production of crops and livestock), as calculated annually by the Bureau of Labor Statistics from the quarter sample data of the Current Population Survey, less appropriate taxes and the average cost of a health insurance policy, as determined by the Secretary.”
BHPr-2000/08
9/15/98
HEALTH RESOURCES AND SERVICES ADMINISTRATION
FISCAL
YEAR 2001 DHHS LEGISLATIVE PROPOSAL
National Vaccine Injury Compensation Program:
Change
Advisory Commission Meeting Schedule Requirement
Eliminate the requirement that the Advisory Commission on Childhood Vaccines (ACCV) meet at least four times each year.
Current Law: Section 2119© of the Public Health Service Act specifies that the ACCV must meet “not less often than four times per year.”
Proposal: Delete from Section 2119© of the Public Health Service Act, the requirement that the ACCV meet at least four times per year.
Rationale: In its current form, the law limits the flexibility of the Commission to coordinate its meeting schedule with the schedules of related advisory committees which meet three times per year. This would bring the provisions governing the operation of the ACCV more in line with laws and regulations governing other advisory committees reporting to the Secretary of Health and Human Services, which do not have stated requirements for the number of annual meetings. For those years in which the Commission feels it can accomplish its business in less than four meetings, significant savings will be realized in reduced salary, travel, and meeting-related costs.
The Advisory Commission on Childhood Vaccines (ACCV) is mandated to advise and make recommendations to the Secretary of Health and Human Services on issues relating to the operation of the VICP. The ACCV voted unanimously to recommend that the Secretary propose legislation which would eliminate the requirement that the ACCV meet at least four times per year.
Effect on Beneficiaries: This change will have no effect on beneficiaries.
Cost: Each meeting of the ACCV costs approximately $25,000. Should the frequency decline, there would be savings of $25,000 per meeting.
Other Data: Section 2119© would be changed to eliminate the phrase “not less often than four times per year” and would read as follows:
“(c) MEETINGS.--The Commission shall meet within 60 days after all
members of the Commission are appointed, and thereafter shall meet not less
often than four times per year and at the call of the chair. A
quorum...”
BHPr-2000/09
9/15/98
HEALTH RESOURCES AND SERVICES ADMINISTRATION
FISCAL
YEAR 2001 DHHS LEGISLATIVE PROPOSAL
National Vaccine Injury Compensation Program:
Change
Advisory Commission Membership Criteria
Specify that the two seats on the Advisory Commission on Childhood Vaccines (ACCV) which are set aside for representatives of children injured by vaccines may also be filled by representatives of vaccine-injured adults or individuals who have suffered vaccine-related injuries.
Current Law: Section 2119(a)(1)(B) of the Public Health Service Act specifies that three members of the ACCV must be members of the general public and that of those three at least two must be legal representatives of children who have suffered a vaccine-related injury or death.
Proposal: Expand the criteria for potential appointment to the two reserved general public seats on the ACCV under Section 2119(a)(1)(B) of the Public Health Service Act to include individuals who have suffered a vaccine-related injury either as children or as adults and to include legal representatives of adults injured by vaccines either as children or as adults.
Rationale: Current law specifies criteria for membership on the ACCV. The ACCV is made up of experts who either possess specific training, medical or legal, or who have personal experience gained as the legal representatives of vaccine-injured children. While this brings together a diverse group of very knowledgeable individuals, it ignores a pool of potential members who would provide the ACCV with a unique, and desired, viewpoint, i.e., that of an individual who has actually suffered an injury related to a vaccine. While the number of adults injured by vaccines is currently small, this pool of potential members will continue to expand as injured children mature to adulthood. In its current form, the law does not provide an opportunity for adult individuals who have suffered vaccine-related injuries to participate as members of the ACCV, or for the representatives of injured adults to participate. The opportunity to participate on the ACCV should be made available to these individuals in order to obtain their unique viewpoint on ACCV issues.
Effect on Beneficiaries: This change will broaden the scope of potential membership on the ACCV to make the membership more representative of the pool of injured individuals.
Cost: There will be no increase in costs as a result of this change.
Other Data: Section 2119(a)(1)(B) would be changed to include vaccine injured adults and the legal representatives of adults who have suffered a vaccine-related injury in the pool of potential ACCV members to be chosen from the general public as follows:
“(B) Three members from the general public of whom at least two shall be either legal representatives of individuals who have suffered a vaccine-related injury or death, or individuals who have themselves suffered a vaccine-related injury.”
BHPr-2000/10
9/15/98
HEALTH RESOURCES AND SERVICES ADMINISTRATION
FISCAL
YEAR 2001 DHHS LEGISLATIVE PROPOSAL
National Vaccine Injury Compensation Program:
Changes
to the Rulemaking Process for the Vaccine Injury Table
Change the rulemaking process for amending the Vaccine Injury Table (the Table) by reducing the period for public comment from 180 days to 60 days, and eliminating the requirement for a public hearing.
Current Law: Section 2114(c)(1) of the Public Health Service Act stipulates that in promulgating regulations to modify the Vaccine Injury Table, the Secretary (DHHS) shall provide for notice and opportunity for a public hearing and at least 180 days of public comment.
Proposal: Delete from Section 2114(c)(1) of the Public Health Service Act the phrase which stipulates that 180 days be allowed for comments on proposed changes to the Vaccine Injury Table (the Table) as well as that a public hearing be held. The period allowed for public comment will be changed to 60 days.
Rationale: In its current form, the law causes unnecessary delays and an unnecessarily onerous process for making changes to the Table. The shortened timeframe for comment will make it possible to reflect new scientific information relating to adverse events associated with the administration of childhood vaccines on the Table much sooner, and thus provide for a simplified claims adjudication process. Eliminating the requirement for a separate public hearing on proposed changes to the Table will not limit the opportunity of the public to comment and eliminates a requirement that in practice has had limited, if any added value . For example, at the last public hearing, held on September 11, 1997, no one appeared to provide testimony. Changes must still be discussed and acted on by the Advisory Commission on Childhood Vaccines (ACCV) at its meetings, which are open to the public. The public is provided with ample notice of the discussion of such items through publication of ACCV agendas in the Federal Register.
The Advisory Commission on Childhood Vaccines (ACCV) is mandated to advise and make recommendations to the Secretary of Health and Human Services on issues relating to the operation of the VICP. The ACCV voted unanimously to recommend that the Secretary propose legislation which would streamline the rulemaking process for amending the Vaccine Injury Table.
Effect on Beneficiaries: This change will enhance the Program’s ability to provide appropriate compensation to beneficiaries by providing a simplified and streamlined process consistent with the general rulemaking process for the DHHS.
Cost: There will be no increase in costs associated with this proposal.
Other Data: Section 2114(c)(1) would be modified to change the requirement for a 180 day comment period to a 60 day comment period, and would delete the requirement to hold a public hearing when changes are proposed to the Vaccine Injury Table. The section would read:
“(c) ADMINISTRATIVE REVISION OF THE TABLE.--
(1) The Secretary may promulgate regulations to modify in accordance
with paragraph (3) the Vaccine Injury Table. In promulgating such regulations,
the Secretary shall provide for notice and opportunity for a public
hearing and at least 180 60 days of public comment.”
BHPr-2000/11
9/15/98
HEALTH RESOURCES AND SERVICES ADMINISTRATION
FISCAL
YEAR 2001 DHHS LEGISLATIVE PROPOSAL
National Vaccine Injury Compensation Program:
Extension of Current Statute of Limitations
Extend the current statute of limitations from 3 years for injury claims and 2 years for death claims, to 6 years for those claiming injury or death resulting from a covered vaccine.
Current Law: Section 2116(a) of the Public Health Service Act establishes timeframes governing the filing of petitions for compensation under the program. Subsection (a)(2) requires that a petition for compensation based on a claim of vaccine-related injury be filed no later than 36 months following the date of the occurrence of the first symptom or manifestation of onset or of the significant aggravation of such injury. Subsection (a)(3) requires that a petition for compensation based on a claim of vaccine-related death be filed no later than 24 months from the date of the death.
Proposal: Revise the references to filing limits in Section 2116(a)(2) and (a)(3) of the Public Health Service Act by replacing them with one standard limit of six years.
Rationale: For vaccines included in the original Vaccine Injury Table (the Table), petitions must be filed within 24 months for deaths and 36 months for injuries. For vaccines and injuries subsequently added to the Table, petitions may be filed for injuries or deaths resulting from vaccines administered up to eight years prior to the effective date of the change which adds the vaccine or injury to the Table. The proposal to increase the timeframe during which petitions for both injuries and deaths related to vaccines currently on the Table to 6 years takes into consideration the significant difference between the time allowed for filing related to vaccines covered in the current Table and filing related to vaccines and conditions added to the table. Setting the revised standard at six years brings it into conformance with the basic standard established by 28 U.S.C.A. § 2501 for claims unrelated to vaccines filed with the U.S. Court of Federal Claims (the Court). In addition to making the standard consistent with the Court’s existing standard, lengthening the period in which petitions may be filed will allow for the more accurate determination of life care needs of the injured party prior to filing. The current situation provides an incentive for petitioners’ attorneys to delay litigation proceedings in order to allow for more time to adequately assess the future medical needs of an injured child.
The Advisory Commission on Childhood Vaccines (ACCV) is mandated to advise and make recommendations to the Secretary of Health and Human Services on issues relating to the operation of the VICP. The ACCV voted unanimously to recommend that the Secretary propose legislation which would extend the statute of limitations governing when a petition alleging injury or death related to administration of a covered vaccine may be filed with the Court.
Effect on Beneficiaries: The proposed change will allow petitioners sufficient time to evaluate the long-term effects of the alleged injury from covered childhood vaccines and develop a better estimate of the life-long needs of the petitioner prior to filing a claim. This will allow cases to move more rapidly through the entire process rather than having to remain on hold while such cost estimates are developed subsequent to the filing of the petition. This change will also reduce the chances that anyone entitled to participate will be excluded due to failure to file within established timeframes.
Cost: Approximately $500,000 per year. The change proposed might result in the receipt of a few petitions which would otherwise be barred. At most, two additional cases might be filed each year by individuals who did not become aware of the VICP until after the original timeframe had expired. Since only about one out of three cases is compensated, this would result in one award every other year.
Other Data: Change Section 2116(a)(2) and (3) to remove references to 36, 24, and 48 month periods and replace them with a standard 6 year period.
“(2) ...no petition may be filed for compensation under the Program
for such injury after the expiration of 36 months 6 years after
the date of the occurrence of the first symptom or manifestation of onset or of
the significant aggravation of such injury, and
(3) a vaccine set forth in the Vaccine Injury Table which is
administered after the effective date of this part, if a death occurred as a
result of the administration of such vaccine, no petition may be filed for
compensation under the Program for such death after the expiration of 24
months from the date of the death and no such petition may be filed more than
48 months more than 6 years after the date of the death, or more than 6
years after the date of the occurrence of the first symptom or
manifestation of onset or of the significant aggravation of the injury from
which the death resulted.”
BHPr-2000/13
12/14/98
HEALTH RESOURCES AND SERVICES ADMINISTRATION
FISCAL
YEAR 2001 DHHS LEGISLATIVE PROPOSAL
National Vaccine Injury Compensation Program:
Exceptional Circumstances for Payment of Attorneys’ Fees and Costs
Allow the U. S. Court of Federal Claims (the Court) the discretion to provide for a check for attorneys’ fees and costs awarded under section 2115(e) to be made payable solely to the attorney for the petitioner.
Current Law: Section 2115 of the Public Health Service Act sets out the compensation which may be awarded to a petitioner under Section 2111. Existing statutory language requires that all compensation be paid to petitioner.
Proposal: Add language to Section 2115(e) of the Public Health Service Act which would allow the Court, in exceptional circumstances and with good cause shown, to provide for a check for the fees and costs incurred by an attorney in a claim filed under the National Vaccine Injury Compensation Program to be made payable solely to the attorney for the petitioner.
Rationale: In its current form the statute requires that all compensation awarded under the program, including attorneys’ fees and costs, be made to the petitioner. This does not provide an avenue for the petitioner’s attorney to be compensated in the exceptional event that a petitioner, whose name is on the check issued for payment of attorneys’ fees and costs, cannot be located or refuses to sign the check making payment to the attorney. The legislative history contained in Committee Report 99-908 indicates that Congress clearly intended that petitioners’ ability to obtain qualified assistance should not be limited. To ensure the greatest interest possible on the part of attorneys in representing vaccine cases before the Court, Congress’ direction was that “the court make adequate provision for attorneys’ time and that the court exercise its discretion to award fees in non-prevailing, good-faith claims.” This intent is contravened if attorneys who have faithfully executed their duties and fully represented petitioners before the Court, can be denied the compensation which Congress intended them to receive. Instances have been documented in which attorneys went unpaid for their time because petitioners whose names are on all checks by law, could not be located or refused to endorse payments which their legal representatives had earned.
This change would make it possible for attorneys to receive payment even when the petitioner refuses to sign the check without getting HHS involved. By allowing the Court to review exceptional cases and make a determination regarding issuance of a new check directly to an attorney, this change would ensure that implementation of the Program is in accordance with the original intent regarding payment of attorney fees and costs.
The Advisory Commission on Childhood Vaccines (ACCV) is mandated to advise and make recommendations to the Secretary of Health and Human Services on issues relating to the operation of the VICP. The ACCV voted unanimously to recommend that the Secretary propose legislation which would allow the Court, under exceptional circumstances and with good cause shown, to provide for issuance of a check for attorneys’ fees and costs directly to the attorney for the petitioner.
Effect on Beneficiaries: This change will not have a direct effect on beneficiaries.
Cost: There is no cost associated with this change.
Other Data: Suggested legislative language attached.
(BHPr-2000/13)
Appendix
Add a new subsection to Section 2115(e) as follows:
“(4)(A) With a petitioner’s express consent, the special master or court may order that attorneys’ fees and costs awarded under paragraph (1) be made payable solely to the attorney for a petitioner.
(B) In the absence of a petitioner’s express consent, the special master or court may order that attorneys’ fees and costs awarded under paragraph (1) be made payable solely to the attorney for a petitioner only in exceptional circumstances for good cause shown.
(C) In determining whether to order that attorneys’ fees and costs be made payable solely to the attorney for a petitioner in accordance with subparagraph (B), the special master shall afford all interested persons, including the petitioner, the Secretary, and the attorney for petitioner, an opportunity to submit relevant information. If the petitioner cannot be located, or refuses to respond to the special master’s request for information, the special master may order that attorneys’ fees and costs be made payable solely to the petitioner’s attorney if the special master determines that there is no practical alternative means to ensure that petitioner’s attorney will be promptly reimbursed for fees and costs incurred in proceeding upon the petition.”
OPHS-2001/01
4/13/00
OFFICE OF PUBLIC HEALTH AND SCIENCE
FISCAL YEAR 2001
DHHS LEGISLATIVE PROPOSAL
National Vaccine Program
Reauthorize the National Vaccine Program.
Current Law: Section 2106 of the Public Health Service Act provides appropriation authority for the conduct of a broad range of activities for the National Vaccine Program, as defined in sections 2101-2105 and 2125-2128 of the Act; and in sections 312-316 of P.L. 99-660, as amended, the National Childhood Vaccine Injury Act of 1986. The existing authority has expired.
Proposal: Reauthorize National Vaccine Program activities for five years.
Rationale: The National Vaccine Program’s legislative mandate of “optimal prevention of human infectious diseases through immunization and optimal prevention against adverse reactions to vaccines” is achieved through coordination and direction of vaccine research and development, vaccine safety assurance, and immunization activities that are brought together in the National Vaccine Plan. The Plan describes the principal policy directions and objectives for programs carried out in the Centers for Disease Control and Prevention (CDC), Department of Defense (DoD), Food and Drug Administration (FDA), Health Care Financing Administration (HCFA), Health Resources and Services Administration (HRSA), National Institutes of Health (NIH), and U.S. Agency for International Development (USAID).
In P.L. 99-660, Congress created the National Vaccine Program–a cross departmental, multi- agency collaboration led by the National Vaccine Program Office (NVPO)–as a vehicle for coordination and intervention to meet public health needs in the prevention of infectious diseases. While each agency has its own separate focus and goals, the National Vaccine Program has successfully created the framework and opportunity, through the Inter-Agency Vaccine Group (IAG), to make collective public health decisions and policy recommendations regarding vaccines and immunizations. This process not only facilitates agency focus and cooperation, but increases the effectiveness of the Federal role in the implementation of a coordinated vaccine policy as the national public health policy leader. The NVPO convenes the IAG composed of major agencies concerned with both vaccine development and use; and an Inter-Agency Vaccine Communications Group (IAVCG) composed of communication and technical experts from the IAG agencies. The IAG membership consists of senior policy and program officials from CDC, DoD, FDA, HCFA, HRSA, NIH, USAID, and NVPO. The IAVCG focuses on enhancing immunization communication efforts across Federal agencies to effectively inform the public about vaccines, encourage appropriate and optimal use of vaccines, and ensure public trust in immunization programs.
The National Vaccine Program and the IAG, in consultation with the National Vaccine Advisory Committee (NVAC), continue to establish new priorities and assess existing ones as emergent issues unfold. It identifies gaps in national efforts in disease prevention, particularly those that can only be addressed by cross-agency collaboration, e.g., development and use of safe and effective vaccines.
Authorization: Such sums as necessary.
BHPr-2001/01
9/21/99
HEALTH RESOURCES AND SERVICES ADMINISTRATION
FISCAL
YEAR 2001 DHHS LEGISLATIVE PROPOSAL
National Advisory Council Term of Student Members
Reduce the current student member term from four years to two years.
Current Law: Section 845 of the Public Health Service Act, as amended by Public Law 105-392, establishes membership terms for the National Advisory Council on Nurse Education and Practice (NACNEP). Subsection (b)(2) defines the appointment by the Secretary of the members of the Advisory Council with each member to serve for 4 years. Subsection (b)(1) requires that 2 of the members be selected from full-time students enrolled in schools of nursing.
Proposal: Revise Section 845(b)(2) of the Public Health Service Act by including specific reference to a 2 year length of term for students appointed to the NACNEP.
Rationale: The current amended Public Health Service Act delineates the membership and terms of its members to the NACNEP for a four year term. This is a change from the previous legislation which specifically defined the student term to be one year with a renewal option. The proposal to decrease the term for the student members from four (4) years to two (2) years takes into consideration the length of nursing education in various nursing programs and the trends in enrollment. Under the current legislation, a student may complete course work, graduate and join the work force after having served only one or two years of the four year term, negating their original student status on the Council.
The proposed change would enable a student to serve a 2 year term while completing the education requirements for the program in which he or she is enrolled.
Effect on Beneficiaries: None.
Cost: None.
BHPr-1998/22
12/7/98
HEALTH RESOURCES AND SERVICES ADMINISTRATION
FISCAL
YEAR 2001 DHHS LEGISLATIVE PROPOSAL
Collecting Unpaid Loans
Allow a School, Lender, Holder, or the Secretary to Garnish an Individual's Disposable Pay to Collect Amounts Owed Under Student Loan Programs.
Current Law: Section 488A of the Higher Education Act allows a guaranty agency, or the Secretary of Education, in the case of loans made, insured, or guaranteed under Title IV of the Act that are held by the Secretary, to garnish up to 10 percent of the disposable pay of an individual to collect amounts owed by the individual. No comparable authority exists for garnishment of an individual's disposable pay to collect amounts owed under loan programs authorized by Titles VII or VIII of the PHS Act, including the Health Education Assistance Loan (HEAL) program, the Health Professions Student Loan (HPSL) program, the Primary Care Loan (PCL) program, the Loans for Disadvantaged Students (LDS) program, and the Nursing Student Loan (NSL) program.
Proposal: Allow a school, lender, holder, or the Secretary to garnish up to 15 percent of an individual's disposable pay to collect amounts owed under Title VII or VIII student loan programs.
Rationale: In states where institutions have the authority to garnish the pay of state employees or other individuals to collect on defaulted student loans, this device has proved effective as a collection tool.
Use of wage garnishment to collect Federally funded and insured Title VII and VIII health professions and nursing student loans has been hampered by varying state laws governing wage garnishment. For example, four states prohibit wage garnishment. Numerous other states place enough restrictions on garnishment to make the process virtually useless as a collection tool.
Since Title VII and VIII borrowers often live in states other than the state where they attended school, relevant schools, lenders, and holders may be further impeded in the use of wage garnishment by the need to learn the legal intricacies and variations of each state's garnishment laws before employing this means of requiring individuals to repay loans.
Section 488A of the Higher Education Act already enables a guaranty agency or the Secretary of Education to garnish up to 10 percent of the disposable pay of an individual to collect amounts owed for a student loan guaranteed by the Department of Education--although representatives of the lending community have advised that a 15 percent limit would be more cost effective. This level is also consistent with Federal garnishment rates.
The proposed amendment to allow a school, lender, holder, or the Secretary to garnish up to 15 percent of the disposable pay of an individual to collect amounts due under Title VII or VIII student loan programs would eliminate problems associated with differing state laws and assure that collectors of Federal and federally-insured loans have the ability to use garnishment consistently and effectively as a collection tool.
Allowing garnishment of an individual's pay for purposes of loan repayment would expedite repayment of education loans. In the case of the school-based HPSL, PCL, LDS, and NSL loan programs, which operate largely on a revolving fund basis, amounts repaid by previously delinquent borrowers would be available for additional loans to new borrowers.
While the proposed amendment would provide for a uniform garnishment procedure in place of varied State provisions, it is not anticipated that this would have significant implications for the roles, rights, or responsibilities of the states.
Cost: None.
Effective Date: Upon enactment; would apply to new and existing borrowers.
HHS-2000/06
3/22/99
DEPARTMENT OF HEALTH AND HUMAN SERVICES
FISCAL YEAR
2001 DHHS LEGISLATIVE PROPOSAL
Expand Fellowship Authority to Include Research Managers
Expand the Current PHS Fellowship Authority to Permit the Appointment of Scientists to Manage and Oversee Research Investigations and Studies
Current Law: Section 207(g) of the Public Health Service Act states: “In accordance with regulations, individual scientists, other than commissioned officers of the Service, may be designated by the Surgeon General to receive fellowships, appointed for duty without regard to the civil-service laws and compensated without regard to the Classification Act of 1923, as amended, and may be assigned for studies or investigations either in this country or abroad during the terms of their fellowships.”
Proposal: Revise the cited fellowship authority to clarify that HHS scientists appointed under these authorities may engage in the management and oversight of research programs.
Rationale: For over 50 years, Section 207(g), and its predecessor sections, have been a primary means of bringing scientists to HHS to carry out research studies and investigations. They are very flexible authorities, allowing HHS to place scientists, from developing post-doctoral scientists to established researchers, by matching them with assignments that best fit their scientific training and interests and the needs of the Department. This enables HHS to quickly address changes in research priorities and program needs without committing long-term resources. However, the statute does not currently permit scientists to be assigned to the highest positions directly related to the management and oversight of research studies and investigations for which advanced scientific and research training and experience of the individuals are a prerequisite. An HHS priority is the need to recruit and appoint strong, widely known and respected high level scientific leaders to engage in the management and oversight of research investigations and studies for time-limited but renewable terms. Existing authorities, such as the Senior Executive Service, are not flexible enough to permit the Department to recruit some of the leading scientists in the world. Amendment to Sections 207(g) is needed to clarify that scientists appointed under these authorities may engage in research studies and investigations as well as the management and oversight of research studies, investigations and programs. This amendment would permit the appointment of distinguished research leaders to high level positions responsible for the management and oversight of internal and extramural research studies, investigations and programs.
This proposal will have no impact on the roles, rights and responsibilities of states, local governments, or tribal governments.
Cost: The authority if approved would be used sparingly. The Department estimates that the additional cost will not exceed $500,000 per year.
Effective Date: Upon enactment.
Recommended Language: “In accordance with regulations, individual scientists, other than commissioned officers of the Service, may be appointed for duty in the Service by the Secretary without regard to the civil service laws and compensated without regard to the Classification Act of 1923, as amended, may hold their appointments under conditions prescribed therein, and may be assigned for the conduct or oversight and management of internal and extramural studies, investigations, and programs either in this country or abroad during the terms of their appointments.
OMH-2000/01
4/12/99
OFFICE OF MINORITY HEALTH
FISCAL YEAR 2001 DHHS
LEGISLATIVE PROPOSAL
Revising Reporting Deadline
Current Law: Title II of Public Law 105-392, the “Health Professions Education Partnerships Act of 1998", amends Title XVII of the Public Health Service (PHS) Act to revise and extend the statutory authority for the Office of Minority Health (OMH). The changes include a new report to Congress describing the minority health activities carried out by OMH during the preceding 2 fiscal years and evaluating the extent to which such activities have been effective in improving the health of racial and ethnic minority groups. The report is also required to include the biennial reports prepared by other PHS agencies summarizing their respective minority health activities. The statute requires that the OMH report be forwarded to the Congress on February 1; the same date the biennial report of PHS agencies are to be forwarded to OMH.
Proposal: Amend Section 1707 (f)(2) of the PHS Act by striking “February 1, 1999" and substituting October 15, 2000. This change will allow OMH sufficient time to review and incorporate the biennial reports of PHS agencies before forwarding a consolidated report to the Congress.
Rationale: Under current law, both Section 201(f)(1) (OMH Report to Congress) and Section 201(f)(2) (PHS agency reports to OMH) have the same deadline – i.e., not later than February 1, 1999 and biennially thereafter. Since the OMH Reports to Congress are to reflect consideration of information provided by the agencies, the deadlines need to be made sequential. For the 1999 Report, OMH requested, via letter of the House and Senate authorizing committees, and was granted, an extension of its statutory deadline to submit the consolidated report. However, this is not an appropriate process for handling future reports.
This request would change the deadline by which PHS agencies must submit their information so that it would precede by 3½ months the deadline for OMH’s Report to Congress for 2001 and subsequent years. This technical amendment would remedy the current anomaly and allow appropriate sequencing for development and incorporation of agency reports into the OMH Report to Congress on Minority Health.
Costs: None
Personnel Requirements: None
Effective Date: Upon enactment
OPA-2000/02
12/14/98
OFFICE OF PUBLIC HEALTH AND SCIENCE
FISCAL YEAR 2001
DHHS LEGISLATIVE PROPOSAL
Adolescent Family Life
Reauthorize Title XX Adolescent Family Life Research and Demonstration Program for Five Years.
Current Law: Title XX of the Public Health Service Act was established in 1981 by P.L. 98-35. Although the authorizing legislation expired in 1985, the program has been operating under authority provided in the annual appropriations process. The AFL program funds three types of activities:
(1) Adolescent pregnancy prevention (abstinence education services) demonstration projects;
(2) Care (health, education, and social services delivery) demonstration projects for pregnant and parenting adolescents; and
(3) Research projects.
Funding for prevention projects is limited to one-third of the total demonstration grant funding available. Both prevention and care projects are required to charge fees for services based on ability to pay.
Proposal: Reauthorize Title XX of the Public Health Service Act for five years
Rationale: Numerous Federal and private programs already exist which provide care services to pregnant and parenting adolescents. There is a great deal of consensus that providing medical, educational and social services results in improved outcomes for both adolescent mothers and their infants -- and evaluations of these programs bear this out. Strategies to prevent adolescent pregnancy, however, are far from agreed upon. There is an urgent need to further implement and evaluate those strategies that have shown the most promise.
There are still gaps in our knowledge about providing care services to pregnant and parenting adolescents. For example, there are unanswered questions about what combinations of services work best for specific population groups, as well as the most effective ways of delivering these services. It is reasonable to continue support for these programs. There are, however, more unanswered questions and more work to be done in the area of prevention. The suggested new language will provide the program with the ability to fund a larger number of prevention projects in a given funding cycle than is now possible.
Authorization Level: Such Sums As Necessary
Effective Date: Upon enactment.
Additional Information
Recent Program History:
In FY 1995, the Department's budget proposed shifting AFL program funds to support a new Office of Adolescent Health, previously authorized by Congress but never funded. However, report language in the 1995 appropriations bill directed the Department to continue funding for AFL. The FY 1997 Omnibus Appropriation provided $6.6 million in increased funding over the previous year for a total of $14.2 million for AFL. It also requires that $9.01 million of these funds be used for new prevention grants utilizing the abstinence education definition contained in section 912 of the P.L. 104-193, Personal Responsibility and Work Opportunity Act of the 1996 (this provision created a new $50 million abstinence-only education program through the Maternal and Child Health Block Grant Program which is to start in FY 1998).
OSG-2000/02
3/25/99
DEPARTMENT OF HEALTH AND HUMAN SERVICES
OFFICE OF THE
SURGEON GENERAL
FISCAL YEAR 2001 DHHS LEGISLATIVE PROPOSAL
Prohibition Against Discharge in Bankruptcy
Prohibit a Debt Incurred for Failure to Complete an Active Duty Obligation to be Discharged through Bankruptcy Proceedings.
Current Law: Pursuant to 42 U.S.C. 218a(b), Public Health Service officers incur a substantial monetary penalty if they fail to complete an active duty obligation incurred for participation in PHS-supported training. A number of individuals have sought to discharge their monetary debt through bankruptcy proceedings because the current law does not bar discharge of the debt is this manner.
Proposal: Bar discharge of a training-incurred debt for a period five years after the debt is incurred and then only if the bankruptcy court finds that non-discharge of the obligation would be unconscionable.
Rationale: This proposal mirrors a provision in the National Health Service Corps law [42 U.S.C. 254o(d)(3)(A)] which bars discharge in bankruptcy of debts incurred for failure to complete a service obligation incurred pursuant to participation in the National Health Service Corps scholarship program. The proposal would increase the incentive for officers to complete their obligated service and would make it less difficult for PHS to collect money owed because of unfulfilled service obligations.
Federalism Impact: None
Cost: None
Personnel Requirements: None
Effective Date: Upon enactment
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