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Review of a Protocol for a Study of Reproductive Health Outcomes Among
The Menopause, Hormone Therapy, and Women's Health
Identifying and Controlling Pulmonary Toxicants
CDC's Case Definition of AIDS: Implications of Proposed Revisions
Do Medicaid and Medicare Patients Sue More Often Than Other Patients?
Difficult-to-Reuse Needles for the Prevention of HIV Infection Among
In addition, the Division testified 8 times.
Listed below are several examples of direct legislative use of the Division's work:
The reports, Genetic Witness: Forensic Uses of DNA Tests, Genetic Monitoring and Screening in the Workplace, Medical Monitoring and Screening in the Workplace--Results of a Survey, and Cystic Fibrosis and DNA Tests: Implications of Carrier Screening, all contributed to report language related to NIH appropriations that suggests establishment of a genetic information and privacy commission.
On October 24, 1992, the President signed Public Law 102-493, the Fertility Clinic Success Rate and Certification Act of 1992, which had been introduced by Congressman Ron Wyden as H.R. 4773. The law calls for each clinic to report its success rates to the Department of Health and Human Services in two ways. One is the statistic proposed by the director of the OTA project that resulted in the May 1988 report Infertility: Medical and Social Choices; the other a more optimistic (but less realistic) statistic endorsed by the practitioners of the art.
3. Additional copies of OTA's Neural Grafting report were requested by the Senate subcommittee on Aging of the Senate Committee on Labor and Human Resources, for use in action on fetal tissue transplantation.
4. The Report The Biology of Mental Disorders was released at a hearing of the Senate Labor and Human Resources Committee. Following that hearing, the report was cited during the floor debate on the HHS appropriations bill in the Senate.
Food and Renewable Resources
The Report, Agricultural Research and Technology Transfer Policies for the 1990s, led to the creation of the Agriculture Science and Technology Review Board, an expansion of the Users Advisory Board, and the determination of research priorities in Title XVI of the Food, Agriculture, Conservation and Trade Act of 1990.
The 1991 report, Agricultural Commodities as Industrial Raw Materials, was instrumental in changing the thinking of Senate and House Appropriations Committees about the advisability of allocating large-scale funds to commercialization activities of traditional and new crops for industrial use by developing a number of commercialization centers.
The OTA report on U.S. Dairy Industry at a Crossroads: Biotechnology and Policy Choices was the basis of hearings conducted by the Senate Committee on Agriculture, Nutrition, and Forestry and the House Committee on Agriculture. The report was subsequently used in drafting and amending legislation to change the dairy price support program and supply management programs for the dairy industry.
The Report, Forest Service Planning: Accommodating Uses, Producing Outputs, and Sustaining Ecosystems, spurred development of a provision to the Interior Appropriations Act requiring the U.S. Forest Service to have and retain an administrative appeals process.
An updated release, Combined Summaries--Technologies to Sustain Tropical Forest Resources and Biological Diversity, was used as briefing material for the Congressional Delegation to the UN Conference on Environment and Development (the "Earth Summit") held June 1992 in Rio de Janeiro, Brazil.
6. The program's most recent publication, A New Technological Era For American Agriculture, is expected to influence legislation related to: food safety, plant and animal protection, biotechnology regulations, and amendments to the Federal Insecticide, and Rodenticide Act.
1. Programs to address several of the research, training, and education needs identified in our 1990 report, Confused Minds, Burdened Families: Finding Help for People With Alzheimer's and Other Dementias, have been mandated by P.L. 102-507, including research on the role of physicians in connecting people with dementia to appropriate services, training for information and referral and case management personnel, and educational grants to inform health care providers and families about the availability of services and funding for services for people with dementia.
2. The project director for OTA's Prevention series and other OTA staff (including OTA's Assistant Director, Health and Life Sciences) provided various committees of the House and Senate with briefings, materials, and advice regarding aspects of prevention. Numerous bills have been introduced that mandate OTA doing various things related to prevention (such as developing a process on how the decision process/standards of evidence/etc. for covering additional prevention technologies should be done). OTA also advised committees and individual Members on issues surrounding Medicare (and general) coverage of colorectal cancer, cervical cancer, etc. This advice and briefings grew out of work on our Prevention Series (screening for colorectal cancer, cholesterol, cervical cancer, glaucoma, and also policy and evaluation issues re: prevention).
3. OTA staff provided information, based on our Pharmaceutical R&D study and on specific spreadsheet analyses, to staff of Senators Kassebaum and Metzenbaum, regarding the implications of whether a $200 million or a $100 million limit should be placed on the amount of revenues an orphan drug can receive without losing its market exclusivity. OTA's analyses indicated the benefits of the higher limit.
OTA staff provided advice to staff of Congressman Mike Kopetski regarding potential financial and organizational impact of the Oregon Medicaid demonstration waiver on Federally Qualified Health Centers (FQHCs) and Federally certified rural health clinics (RHCs).
5. OTA's 3-volume report on Adolescent Health was used by Congress in drafting legislation relating to various aspects of adolescent health. Five bills with the potential to have a substantial impact on adolescent health passed (Preventive Health Amendments of 1992; ADAMHA Reorganization Act, 1992; Indian Health Care Amendments, 1992; Job Training Reform Amendments, 1992; Juvenile Justice and Delinquency Prevention Act,
The Juvenile Justice and Delinquency Prevention Act of 1992 made substantial amendments to a similarly-named act first passed in 1974, including amendments that would improve coordination among Federal, State, and local agencies and emphasize community-based programs and services, including family counseling and coordination of family services. The project director of the OTA Aolescent Health project provided advice to the staff person for the newly re-established Senate Judiciary Subcommittee on Juvenile Justice and Delinquency, on the development of this legislation.
OTA's Adolescent Health report was cited in hearings related to prevention (the House Select Committee on Children, Youth, and Families (May 1991); healthcare reform (the House Select Committee on Children, Youth, and Families (1992); and comprehensive school-based health services (Senate Committee on Labor and Human Resources;( July 1992). The OTA project director met with health staff of Senate Committee on Labor And Human Resources to discuss the revision and reintroduction of Sen. Kennedy's bill on comprehensive school-based health services.
OTA's report was cited in a report on Teens and AIDS published by the House Select Committee on Children, Youth, and Families in May 1992. OTA was asked to review the draft of this report prior to publication.
11.5 Changes in Prior Plans for FY 1992 for the Health and Life Sciences Division
During Fiscal Year 1992, the Health and Life Sciences Division essentially accomplished its goals, with approved modification and additions to meet the changing needs of Congress. These changes reflect the inherent uncertainty of research and the attendant need to be able to make adjustments.
(Please see the chart on page 12 for the breakdown of the differences in estimated and actual Division spending for FY 1992)
11.6 FY 1993 and FY 1994 Priorities for the Health and Life Sciences Division
A Division's work is determined by the expressed needs of Congressional Committees, so we cannot safely predict an agenda, but an illustrative list of subjects that are representative of the kinds of new assessments that we may be asked to undertake can be prepared. Such an exercise, using a wide variety of information sources, helps sharpen the discussions between OTA staff and Congressional Committees. It also reflects one of the charges Congress assigned to OTA: foresight about emerging technology. Of course cach Division can undertake only a few new assessments each year, so this list should be viewed only as representative of potential subjects for the assessments that the Health and Life Sciences Division may be asked to undertake in Fiscal Years 1993 and 1994. Because OTA works hard to be responsive to changing Congressional needs, new work is often significantly different from OTA's prospective list, but it usually does contain some of the identified issues.
Our country's decision to map the human genome has opened wider the window of concern about what information about a person's biology deserves privacy. In a related area, the increased knowledge of the biological bases of mental illness will also raise questions about what kind of information about a person's biochemistry deserves privacy and what kind of information should be released to insurance carriers, law enforcement agencies, and other organizations that will argue that increased efficiency and safety will follow from their having that information. This assessment would delineate what information is now held private and which released, derive whatever lessons those decisions provide for dealing with the new privacy questions, and analyze the methods now being used to make privacy decisions related to new biological technologies. The introduction of bills about genetic privacy in the current Congress illuminates current interest in this area.
ORGAN TRANSPLANTATION: NEW TECHNOLOGIES, NEW ISSUES
Organ transplants are increasingly common surgical procedures; indeed, the limiting factor for some procedures is the availability of donor organs. This assessment would describe the improvements in
transplantation, plot the success rates, analyze the characteristics of the donor and recipient populations, and discuss the possibility of a market in donated organs. It would describe current Federal practices, obtain experts' views about needed changes, and describe the possible outcomes of those changes.
PERFORMANCE ENHANCING DRUGS
Athletes' use of various drugs to enhance physical performance has come to the public's attention because of dangerous side effects. The use of drugs and chemicals to enhance mental performance is a more recent development, but it too has been featured in national news magazines and newspapers. This assessment would investigate what is known about the desirable and non-desirable effects of performance enhancing drugs and explore the possible consequences of new or additional Federal programs directed at prohibition or controlled
During the last decade or so, the Federal Government has invested little in research directed at enhancing fertility or at contraception. Furthermore, U.S. drug firms have done little research in these fields in the same time. With the new administration, which is expected to look with more favor on these activities, it is expected that questions will arise about the government's role in a renewed research program. Some questions come immediately to mind: What has been accomplished by research carried out in other countries? What are the possible markets? What safeguards are necessary? What benefits can be expected from the research?
TECHNOLOGIES FOR ESTIMATING BENEFITS OF OSHA REGULATIONS
With the completion of an on-going assessment that looks at the costs of OSHA regulations and their impacts on productivity, OTA expects a request to look at how OSHA estimates the benefits of its proposed regulations. This project would also draw upon the "health risk assessment research project," also on-going, which is examining methods for estimating human health risks. All of these projects examine some of the technologies in place and needed for the assessment of risks and benefits of new and old technologies and chemicals.
VIOLENCE: ASSAULT ON THE PUBLIC HEALTH
Violence--homicides, accidents, and suicides--is a major cause of death in the U.S. population that is under 50 years of age, and the physical and mental suffering that stems from assaults and accidents fills the hospitals. This assessment would examine violence as a public health problem: What is the extent of the problem? What are its causes? What strategies, especially behavioral ones in the family, school, and community have been used to combat it? How have they worked? What new strategies are promising? What can organizations, including the Congress, do to implement strategies that work? This assessment would probably include a number of background papers; two that come immediately to mind would be: 1) technologies to assess and to intervene, especially by education in child abuse, and 2) investigation of connection between violence and the mentally ill.
Food and Renewable Resources
IMPACTS OF INCREASED AGRICULTURE TRADE ON THE ENVIRONMENT
This study would examine potential impacts on the United States of increased globalization of markets. Using economic and ecological analyses, the study would address probable impacts of crop specialization, agricultural export orientations, pressures on renewable and non-renewable resources, transportation issues, and pest and disease concerns. The focus might include food, fisheries and aqua culture markets, horticulture markets, timber markets, the opening of new trade areas such as the former USSR and South Africa, free trade agreements, harmonization of product and pest risk standards, and GATT. The study could identify technological and institutional improvements likely to be needed within a 10-year time period to respond to identified problems.
TECHNOLOGIES TO USE AND REUSE AGRICULTURAL WATER EFFICIENTLY
Availability of water resources, particularly for agriculture, is a major concern in the United States and globally. If climate change projections are accurate, we can expect the importance of water-use efficiency to increase profoundly in the next 15 to 20 years. Competition between agriculture and other uses over water resources also would be likely to increase, further underscoring needs for increased efficiency and multiple-use systems. An OTA study could identify and assess the: 1) range of technologies employed in agriculture water-use management, 2) new and emerging technologies to enhance water-use efficiency in agriculture, 3) renewable resource-based technologies to reclaim contaminated water, 4) potential effects of widespread implementation of improved technologies on water use in the United States, 5) areas where additional research is needed, and 6) provide options for the Congress to promote enhanced water-use efficiency in agriculture.
PEST CONTROL IN AMERICA: TO 2000 AND BEYOND
Experts predict the nation's arsenal of chemical pesticides will decline significantly during the next decade due to increased reporting requirements under FIFRA. In addition, concerns continue over potential health and environmental effects of chemical pesticides. These factors have stimulated considerable interest in the development of alternative pest control methods. Applications of biological control and "biorational" chemicals (e.g., pheromones and natural toxins) are likely to increase in the near future.
Several important questions arise related to changing pest control strategies: Is national investment in R&D adequate to replace traditional control technologies within the period of expected decline? How realistic are expectations that these alternative technologies actually can eventually replace a significant segment of chemical control? Will the industry infrastructure be sufficient to meet anticipated needs? Existing Federal regulations may not adequately cover biological control, specifically the testing and commercial sale of certain macro organisms. Is new Federal legislation needed? Current U.S. markets for biological control are supplied in part by foreign producers; is there a potential Federal role for enhancing international competitiveness in this area?
IMPLICATIONS OF ENDANGERED SPECIES PROTECTION FOR MANAGEMENT OF RENEWABLE RESOURCES IN THE UNITED STATES
Species deemed to be endangered in the United States currently are required to be protected from further harm by public or private entities. The U.S. Fish and Wildlife Service or National Marine Fisheries Service are required to make efforts to promote population recovery. Although the intent and procedures of the Endangered Species Act (ESA) are clear, a number of scientific and technological issues make its implementation difficult and controversial. For example, under the ESA "species" are defined to include genetically divergent populations of the same traditionally-defined species. Advances in biotechnology allow ever more refined identification of genetic differences, and genetic engineering can generate multitudinous new hybrids. OTA could examine the implications of such technologies for protection of endangered species, and assess resource management technologies to protect categories of endangered species: 1) small populations of endemic species (e.g., Snail Darter), 2) wider-ranging species (e.g., spotted owl), 3) highly migratory species (e.g., certain birds, whales, and fishes), and 4) intermittent species (i.e., those that appear only during certain ecological conditions, such as plants whose seeds remain dormant in the soil until specific moisture regimes occur).
TECHNOLOGIES FOR ECOLOGICAL RESTORATION
The number of Federal laws mandating ecological restoration of degraded habitats (e.g., mining sites, abandoned agricultural fields, and landfills) continues to grow. Yet few criteria exist for methods and endpoints of restoration efforts. Consequently, key aspects of restored systems sometimes are flawed, such as species composition or habitat structure and stability. Under such conditions, restoration efforts can fail to achieve desired goals, for example in providing habitat for endangered species. Where restoration of one site is "traded"