N92IO14AL ADVISORY COUT,,ICIL ON REGIONAL TQMICAL PROGRAMS Subco,@ttee to Consider Implementation of Sect!-on 910 - Grants for ivlultipro es The Subcommittee met at 8:30 a.m. on July 12, 1969, in the Board Room of the Clinical CeiiL,eil at the National Institutes of Health. All appointed members were present,: Dr. John R. Hogness, Chairman Dr. Clark. H. Milli-kan Mrs. Florence R. Wyckoff Dr William D. Mayer, Member, Regional- Medical Programs Review Committee Dr. William Stoneman III, Coordinator., Bi-State RMP Dr. Theodore Cooper, Director, National Ileart Institute IDTS Staff members presents: Dr. Donald R. Chadvjick, Deputy Director Mrs. Martha L. Phillips, Associate Director for Grant and Contract Policy Dr. Richard F. Manegold, Associate Director for n@IP Operations anct Development Dr. Samuel Fox, JIT . Chief, Heart Disease and Stroke Control @gic-mi As a result of,its deliberations, the Subcorm@ittee presents to the National Advisory Council the following recoi-mc-iidations: I. Project Grants for imultiprogram Services, under the authority of Section 910 of Title IX of the Public Health Service Act, must be made exclusively for activities which are supportive of the goals and objectives of Regional Medical Programs. It is riot only appropriate but desirable that this mechanism be used for support of activities of interest and service to all of the Regional Medical Programs in the Nation, as well as activities of interest to any two or more geographically related Regional Medical Programs. Under the circ=-ta-Tices of the present legislative authority and the current budgetary 1241ra'tati-on, support of activities in the 55 Regional Medical Programs must be given the first priority. To the extent that MLLItiprogram Services can be funded it is irtiriortant- to recognize and consider them in two major categories, defending on the source of the initiative Page 2 Section 910 Meeting for their development and submission: 1. Projects arising from the initiative of, and designed to serve,- two or more Regional Medical- Programs must be - Clearly and sharply directed toward producing imovations in cooperative arrangements in and among the Regions involved; - Of high priority to the Regions involved, and approved as such by each Regional Advisory Group. ('Ihis mechanism may not be used to circumvent the review procedures of individual Regions); and - Show that the programs of the Regions involved are better served by a Multiprogram Service than they would be by a single Regional approach to the project. Projects will not be considered for funding under this mechanism if they-have been rejected previously, on the basis of scientific merit, as a part of a single Regional Medical Program application. 2. Among projects arising from-the initiative of a single agency and planned to serve the interest of Regional Medical Programs nationally, primary emphasis, at least for the present,, should be placed on projects in two general categories; - Tbp priority being given to support of institutions and organizations which provide training in disciplines of special importance in the development of RMP professional staff competence; and - Second priority to the support of services and resources to be provided in one or more central locations which will further the general goals of Regional Medical Programs nationally; each application providing a clear identification and documentation of the need for the service by the several Regional Medical Programs. Review of applications for Yiul-'Iiprogram Services grants should follow essentially the same process as currently employed for Regional applications. Applicants should be advised to be in coranunications with staff of Regional Medical Programs Service during the preparation and development of the project. Applications should be screened by staff for the need for collateral review by subject matter exi-)erts includino- in soin(,- instances, the staff and consultant represertati.ves of the appropriate Iq@@L-ional Institute of Ile-alth (see discussion of Section 910 MeetinfT Clinical Field @ials) and then forwarded to the RMP Review Co@ttee with their assessment. The application is then to M4 be sub -Ltted to the 14ational Advisory Council on Regional Medical Ppogr,%-ns with the recom--ndation of the Review Co@ttee and, where appropriate, a statement froi-n the National Advisory Council of the reviewing Institute. II. Clinical field trials are, under specific circumstances, appropriate activities for Regional Medical Programs and may be funded as part of an operational grant under Section 904 or as a Multiprogram Service under Section 910. In either case the trial must: Involve the applicability of a scientifically proven method of intervention in a disease process and utilize methods the scientific merit of which is established and Be directed to the establishment of a system of cooperative arrangements which will contribute to the improvement of the health care ol@ the study subjects. Grants under Section 910 for clinical field trials which meet the 4 above criteria are to be limited to the funding of a central service essential for the study in two or more Regions, when such service is requested, and the methods of its provision approved by the Re-ional Medical Programs to be involved in the trials. III. In response to the request for recomendations for the preliminary disposition of the two proposals for the study of the -Clofibrate (#910-5, California ReFibnal Medical Pr-op;ram and #910--5A., of Southern California), the subcormdttee agreed that neither is appropriate for support under Regional Medical Programs since they do not fulfill either of the criteria recomended above. . Trie biological investigation of the mechanism to be studied is not yet satisfactorily completed and sufficient informtion is available to indicate that additional pr y work needs to be done on the possible toxic side effects of -the druo, itself. C> . Neither is directed toward the trial of a system of cooperative arrangements to improve the care of the patient involved. August 12, 2.969