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yet to learn. We are committed to giving the American people a substantial return on their generous investments in the NIH.

We will be pleased to respond as best we can to questions that you have.

[The statement follows:)


Mr. Chairman, I am privileged to appear before the Subcommittee to present the President's FY 1992 budget proposal for the National Institutes of Health. I will touch on some significant research advances that have been made during the past year, describe briefly our management plan for funding research grants, and outline the highlights of the FY 1992 budget proposal.

Subsequently, the Directors of the several Institutes, Centers, and Divisions will extend and amplify selected topics from their unique perspectives.


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Enormous progress is being made in molecular genetics, pointing
the way to totally new forms of therapy. Last September a team
of scientists from the National Heart, Lung, and Blood
Institute and the National Cancer Institute initiated the first
clinical trial of human gene therapy by infusing a severely
immunodeficient 4-year-old girl with her own white blood cells
into which a normal adenosine deaminase (ADA) gene had been
inserted. The patient has ADA deficiency disease, an extremely
rare inherited disease that can cause death if untreated.
the latest report the young girl was doing well.


Then, on January 29 this year the same team of NIH scientists
performed the first gene therapy for cancer patients. Two
patients were given transfusions of genetically modified tumor
infiltrating lymphocytes (TIL) removed from their own tumors.
These naturally occurring cancer-killing cells were armed in
the laboratory with a gene capable of producing tumor necrosis
factor (TNF), a potent antitumor toxin. The genetically
altered cancer-killing cells that were returned to the patients
are expected to carry the TNF gene directly to the tumor
site(s), thereby potentially maximizing the gene's benefit and
avoiding the toxicity that could result if TNF were distributed
throughout the body. If INF is active throughout the body for
too long or at too high a concentration, it can cause shock and
body wasting.

These unparalleled advances also provide excellent examples of the unique ability of the NIH intramural environment to foster sustained collaborative efforts by leading scientists across disciplinary and organizational lines.

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Last year brought a major clinical advance in the treatment of spinal cord injury. A clinical trial supported by grants from the National Institute of Neurological Disorders and Stroke demonstrated the first effective treatment for this devastating problem experienced by about 10,000 Americans each year. When patients in the study were given large doses of the drug methylprednisolone within eight hours of their injury, they regained significantly more motor and sensory function than untreated patients or those who received another drug.

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The NIH continued its aggressive support of laboratory and clinical research directly geared toward developing new treatments and potential vaccines for AIDS. In this connec

tion, I note a particular finding by scientists at the New
England and the Delta Regional Primate Centers supported by the
National Center for Research Resources and the National
Institute of Allergy and Infectious Diseases. They demon-
strated that a vaccine against simian immunodeficiency virus
(SIV) could confer protection upon rhesus monkeys. Within a
matter of days program leaders at NIH and elsewhere stopped
saying "If we can develop a vaccine against HIV...." and
instead were saying "When we develop a vaccine... The SIV-
infected monkey gives us an extremely valuable means to unravel
the details of how this retrovirus and its cousins produce
life-threatening dysfunction of the immune system.

None of these scientific advances would have been possible without laboratory animals. They illustrate the indispensability of research with anim s and its extraordinary importance for combatting human disease and disability. The work with SIV and monkeys almost certainly will set the pace of progress for much of the AIDS research effort for the foreseeable future. Similarly, the use of animals was crucial to the progress of the gene therapy studies and the work on spinal cord injury.

These many

The scientific developments that I have highlighted and the others that will be presented in subsequent testimony demonstrate that the biomedical research community is entering the 1990s with unprecedented opportunities for new discoveries that will improve human health. Indeed, we are now supporting more biomedical research scientists today than at any point in history. scientists will be available to pursue an unprecedented number of these opportunities. When discussing scientific opportunities, it should be noted that the very nature of scientific progress means that with every new discovery or advance, more new opportunities are uncovered--and that it becomes obvious that it would be impossible to pursue every one of this ever multiplying number of opportunities. The NIH is pursuing a record level of these opportunities and works to ensure that the Nation's resources are applied to those investigations with the greatest chances of success. It should also be noted that these opportunities arise in the context of substantial increases in the costs of conducting biomedical research and the prospect of tight restraints on domestic spending by the Federal Government.

In response to these realities, the NIH has developed and put into practice the financial management plan called for by the House and Senate Appropriations Committees. The core idea is to impose specific constraints on the year-to-year growth of the costs of grants in the aggregate, but to allow the informed judgement of peer reviewers and staff to obtain on a grant-by-grant basis within these ceilings. The plan takes into account the need for its continuing evaluation and refinement in consultation with Congress and, the biomedical research community. The FY 1992 NIH budget request was formulated in accordance with the principles of the financial management plan.

The President's FY 1992 request for the NIH totals $8,774.9 million, an increase of $498.1 million or 6 percent over the FY 1991 level. Included in this request is $851.2 million for AIDS, an increase of 5.8 percent; $110.5 million for the Human Genome

Program, an increase of 26.4 percent; and $112.6 million for minority programs, an increase of 26.1 percent.

Within the requested total for FY 1992, NIH concentrated heavily on providing substantial increases to the most researchintensive mechanisms, especially those supporting basic research. Thus, research project grants, research centers, cooperative clinical research, R & D contracts, the intramural program, and cancer prevention and control were accorded the largest increases. In the aggregate, an increase of 7.6 percent is requested for these mechanisms. Research project grants would be funded at a level of $4,892.8 million, which is 8.8 percent over the FY 1991 level. That is 3 percent real growth when compared with the Biomedical Research and Development Price Index, which currently is 5.8 percent.

The requested amount would fund 21,818 research project grants, 632 more than in FY 1991, and the highest number ever in one year. This includes support for 5,785 competing research project grants, the same level as the current fiscal year. The funded rate for competing grants, that is, the percent of reviewed applications funded, would be 26 percent.

The NIH believes it is critical that a stable number of research trainees receive support and that adequate stipend levels be provided. Thus, the FY 1992 request of $314.6 million will support a total of 12,318 trainees, an increase of 140 trainees over the FY 1991 level, while providing for a 4 percent increase in stipends.

Manifesting the high priority that the NIH attaches to improving the health status of minorities and to addressing minority underrepresentation in biomedical research, the budget request includes an overall increase of 26.1 percent for NIH programs designed to assist minority biomedical researchers. An important feature of the budget is the provision of $15 million to initiate a new Research Facility Improvement Program for renovation of existing facilities and the construction of new facilities at historically Black colleges and universities and similar institutions; these institutions will be assisted toward making their environments competitive with those of research-intensive majority institutions.

The intramural research program at NIH constitutes the Nation's preeminent institution for biomedical sciences. The excellence of NIH scientists and the exceptional intramural facilities afford many research opportunities that do not exist elsewhere. The request for intramural research of $987.9 million provides an increase of 6.8 percent over the FY 1991 level; included in the request is a onetime amount of $4.2 million to outfit the new Silvio 0. Conte Child Health/Neuroscience Building. Also featured in the budget request is $104 million to continue the multiyear effort to revitalize the infrastructure of NIH research laboratories and supporting systems.

In FY 1992, the NIH proposes to continue the Biomedical/Life Science Education Program it launched in FY 1991 to stimulate interest in biomedical careers in the pre-college years and to promote adult science literacy. This new program is designed to complement the general science and math education initiatives being spearheaded by the National Science Foundation and the Department of Education.

The request includes $2.5 million for the new Office of Minority Programs, which is responsible for establishing NIH-wide goals and policies for activities targeted at research and training related to minorities. Leadership in this program will be provided by the newly-appointed Associate Director for Minority Programs. This program is a part of NIH's effort to address overall minority program direction and improve minority health.

With respect to employment of personnel within the Agency, the NIH has outlined its plans for increasing the number of minorities and women in applicant pools by undertaking special outreach and recruitment efforts. Increased representation of minorities and women in applicant pools will eventually result in more hiring from these groups.

Increased emphasis will be placed on providing quality training and career development opportunities to address underrepresentation and salary disparities among the various groups.

The request also includes $2.5 million for the Office of Women's Health Research. Using these funds, the NIH Associate Director for Research on Women's Health will work with the Institutes to ensure that research pertaining to women's health is identified and addressed through activities conducted and supported by the NIH.

Within the Office of the Director, a total of $20 million is requested for the Director's Discretionary Fund. This fund proved particularly valuable to date during FY 1991 in providing resources to launch preliminary efforts relevant to science education, minority health, and women's health described above. Requested funding for the National Library of Medicine of $100.54 million is a 10 percent increase over the FY 1991 level and includes a $3 million increase for NLM activities related to the multiagency High Performance Computing and Communications Initiative being coordinated by the White House Office of Science and Technology Policy.

The year 1992 promises to be another good one for NIH, as the Agency continues exploring the frontiers of biomedical research in an effort to improve human health. Many, many scientific inquiries will be supported, helping to ensure a healthier future for the citizens of the United States.

I would be pleased to respond to your questions.


Senator HARKIN. Thank you very much, Dr. Raub.
Senator Hatfield.

Senator HATFIELD. Mr. Chairman, you are very gracious. Thank you very much.

Senator HARKIN. I appreciate your being here.

Senator HATFIELD. Dr. Raub, could you give us a little assessment of your math/science initiative that we commended you and encouraged you to expand last year in the Senate report? As you know, since that time, Senator Kennedy and I have succeeded in passing, I guess, the only education legislation enacted last session in establishing regional math/science centers. These centers will address the same duality of developing interest at the elementary school level in math/science and to also renew the interest of teach

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