Question: X-ray technology is moving forward with astonishing speed and complexity. How do these advances relate to one another, and can you realistically expect such devices to pay for themselves in terms of medical as well as societal benefits?

CAT

The

Answer: X-ray technology as a method of medical diagnostic and research imaging has progressed rapidly in recent years. scanners have become an essential tool for patient diagnosis. computer techniques developed for CAT imaging are now being modified for use with ultrasonic imaging techniques. PETT scanners can be used to monitor metabolic processes and NMR imaging (zeugmatography) detects proton densities. Industry has very active programs for development of NMR imaging systems and feels that this technique has great potential as a research and diagnosis tool. These techniques each measure different parameters and from a research point of view are different but complementary.

The DRR is not involved in support of direct patient care and thus cannot realistically project the costs or benefits of these various imaging techniques to patients or physicians. From a research point of view, each of these technologies will provide independent information on human systems and diseases, hopefully leading to better treatment with minimum radiation risk.

EQUIPMENT

Question: What role does the Division play in the

development or procurement of computer hardware and software for either the NIH Institutes or outside requests for such equipment?

Answer: The Biotechnology Research Program of the DRR supports regional and national resources developing complex methods, specialized expertise and state-of-the-art hardware for applications in biomedical research. The Program has had a long history of supporting innovative solutions for biomedical problems. The following task dedicated systems were developed within the Biotechnology Resources Program:

We expect to continue the marriage of state-of-the-art computer capabilities to the needs of researchers supported by the NIH. The experts in our Biotechnology Resources are uniquely equipped to arrange this marriage by defining the unmet not yet clearly seen. needs and then prepare solutions from ever-changing hardware and software. Our grantees are now examining needs for task dedicated systems which are expert in determining the structure of biologically active compounds, in consulting for glaucoma, rheumatology and internal medicine and in methods of medical decision analysis. Opportunities for commercial diffusion will be greatly enhanced by the cost reductions afforded by the very large scale integrated (VLSI) circuit technology. Two of our experts are working on a new set of design principles that can reduce the design problem to five man months from the fifty man months presently needed to produce a successful VLSI device. This new expertise will greatly increase the program's potential to serve the scientists working on health problems.

Question:

What, if anything, does DRR have to do with the PETT (Positron Emission Transverse Tomography) program now under development at the National Institute of Neurological and Communicative Disorders and Stroke?

Answer: The only activity supported by the DRR involving PETT, Positron Emission Transverse Tomography, is at our resource at Washington University in St. Louis. One role of this resource is to continue to explore new research capabilities in collaboration with NINCDS grant for PETT work at this institution. The latest work is to develop and design a PETT time-of-flight capability. This new capability will actually determine where on a line containing the positron emission the point of emission Occurs. The ability to do this will allow reconstruction of dynamic images, much higher image resolution of positron processes in regions of interest, decrease radiation doses to patients, and provide shorter scan durations.

DETERIORATION OF EQUIPMENT AND FACILITIES

Question: What success have you had in determining the seriousness of the deterioration of equipment and facilities at colleges and universities?

Answer: This is a very difficult and complex question which has resulted in several major studies in the past several years. These studies and surveys continue to identify equipment that has worn out and not been replaced, newly developed equipment that is not being provided to investigators, and new technology in engineering, physical sciences, and mathematics that need to be adapted and applied to biomedical research. These are the three ways in which deterioration of research equipment has become serious in institutions that conduct biomedical research.

We have no way of determining just how serious the deterioration problem is, but from grant applications, scientific papers, discussions with principal investigators, observations at project site visits, and the many requests we receive from colleges and universities for facilities and equipment support, it is apparent that the problem is substantial, and growing as more and more large shared equipment items continue to wear out or become obsolete due to new technology.

INCREASED COSTS OF MEDICAL EQUIPMENT AND DEVICES

Question: Has the cost of medical equipment and devices increased at a disproportionate rate compared to other elements in your budget?

Answer: Compared to other elements of our budget, equipment costs have not increased disproportionately. In fact, personnel costs are taking a larger part of the budget then used to be true, probably the result of differential growth rates in research personnel costs generally as compared to the DRR budget. The cost of medical equipment for research (capital costs, operating, and maintenance costs) has increased partly because of inflation, but largely because of advances in its complexity and sophistication. This increased cost is more than offset by the dramatic increases in the capability of the equipment. Advances in capability result in reduced costs because of savings in time required to complete a research task, and in greater productivity and quality of results because of increased precision and achievements that otherwise would not be possible.

OBJECTIVES OF THE BRSG PROGRAM

Question: The Biomedical Research Support Grants Program, we are told, has operated for 19 years and received an estimated $800 million in appropriations over that period. Yet we are advised that your program objectives are so general you cannot measure the extent to which they are being met. What is your comment on this?

Answer: We are concerned that recent opinions written on the subject seem to imply that because the Biomedical Research Support Grant (BRSG) Program has broad objectives which do not lend themselves easily to precise measurement, NIH should make adjustments to assure the objectives be changed or redefined to make them measurable and quantifiable. Specific measurable and time bound objectives are not present in the BRSG Program in keeping with the basic intent in order to help institutional programs be adaptable, flexible and able to respond to a wide variety of requirements and demands in the biomedical research community which occur with the passage of time.

Question:

Program.

Please state the official objectives of the

Answer: The objectives of the Program are to provide funds on a continuing basis to eligible institutions heavily engaged in health-related research to strengthen their programs by allowing flexibility available to the institutions to meet emerging opportunities in research, to explore new and unorthodox ideas, and to use these research funds in ways and purposes which they (the institutions), in their judgement, feel would contribute effectively to the furtherance of their research program.

EVALUATION OF THE BRSG PROGRAM

Question: Have you established a firm date for making an objective assessment of the program? If not, why not?

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Answer: As yet, we have not established a firm date for making an objective assessment of the program. However, we intend to continue our efforts to restate the objectives of the Biomedical Research Support Grant Program as more measurable objectives by June 30, 1981. Included in this time frame are meetings of the General Research Support Review Committee and the National Advisory Research Resources Council, both of which will consider this problem and provide staff with advice on restating these objectives. However, advisors and staff may conclude that the objectives for this program are best left alone; that the program's effectiveness would be constrained by more measurable goals. Then, by September 30, 1981, we will have either arrived at a strategy by which to conduct the evaluation against the newly stated objectives, or with the assistance of our advisers and NIH evaluation staff, arrived at the conclusion that existing evaluation methodologies cannot be used to evaluate this program at this time.

Question: How long will it take to complete a program evaluation effort whose results can be used to guide future program funding levels?

Answer: As noted above, we intend to have completed an evaluation of the program and restated the objectives of the Biomedical Research Support Grant Program in as measurable terms as possible by June 30 of this year; however, it is important to note that, during the 19 years of the program's existence, specific measurable and time-bound objectives have not been present. In keeping with the basic intent to help institutional programs to be adaptable, flexible, and able to have the ability of responding to a wide variety of requirements and demands in the biomedical research community which occur with the passage of time, studies by the National Research Council of the National Academy of Sciences in 1965, by two nonfederal consultants in 1969, and by the Research Resources Evaluation Panel in 1976 have all concluded that this program is exceptionally important to research institutions in this country, specifically because of its flexible nature and broad objectives. In summary, there is significant disagreement among knowledgeable staff and advisors about whether the development of specific and measurable program objectives can enhance or might seriously damage the Biomedical Research Support Program.

[CLERK'S NOTE.-The following is the administration's response to those questions in the record that were under review by the Secretary at the time the Department submitted earlier responses.]

REORGANIZATION OF DRR

Senator Specter: Since another study on possible

reorganization of the Division is under active consideration, what are the circumstances that warrant still another effort in that direction?

Answer: There is always a need to be sure that Federal programs are managed in the most effective and cost efficient manner possible. In the case of the Division of Research Resources' programs, we have an organization which is the focus for noncategorical programs in support of NIH's extramural research effort. Since most of NIH's extramural programs are categorical in nature, it is appropriate for the NIH Director to

consider again whether such a noncategorical focus is the best way to organize these programs within the NIH.

Senator Specter: In the event of a reorganization, can there be assurance regarding continued support for General Clinical Research Centers, Biotechnology Resources, and Biomedical Research Support Programs?

Answer: I am confident that the primary concern of the Director, NIH, in consideration of any options with respect to reorganization of DRR programs would be that these national research resource programs continue to be available to the biomedical research community in support of the NIH research effort.

Senator Specter: In view of the Division's demonstrable success in administering these large and complex resource programs, what provision could be made to preserve that expertise?

Answer: If another organizational focus is decided upon for the DRR programs, I am certain that the Director would wish to have the staff expertise continue to remain associated with those programs.

Senator Specter: If the Division's activities were redistributed to other NIH organizations, is there any assurance that the Minority Biomedical Support Program would be continued?

Answer: The Minority Biomedical Support Program is NIH's major extramural activity concerned with improving the biomedical research capability of minority institutions and encouraging more minority students and faculty members to be involved in healthrelated research. The Program will continue to receive high

priority.

MAINTAINING NEW AND COMPETING GRANTS

Question: How much funding will you need in fiscal years 1981 and 1982 to maintain your share of the NIH goal of 5,000 new and competing research grants?

Answer: The revised budget request, proposed by President Reagan provides for the funding of approximately 4,900 new and competing research project grants for $571,621,000. The Division of Research Resources does not plan to fund any research project grants in 1981 or 1982. All of DRR's extramural grant support goes into the research centers and the other research mechanisms.

Question: How is inflation impacting--or how will it impact--on this goal? What inflator are you using?

Answer: The Division of Research Resources does not support any research project grants, and thus, has no impact on the goal of stabilization.

Question: To what "Payline" will you fund new and competing grants in fiscal 1981--and if you can estimate it--in FY 1982?