D E P A R T M E N T 0 F H E A L T 11, E D U C A T@l 0 N A N D W E L F A R E National Institutes of Health Division of Regional Medical Programs Natibnal Advisory Council on Regional Medical Programs Minutes of Meeting February 19-21, 1967 National Institutes of Health Conference Room 4 Building 31 DEPART14ENf OF HEALTH, EDUCATION, AND WELFARE PUBLIC HEALTH SERVICE- NATIONAL ADVISORY COUNCIL ON REGIONAL MEDICAL PROGRAMS Minutes of Seventh Meeting 2/ February 19-21, 1967 The National Advisory Council on Regional Medical Programs convened for its seventh meeting at 8:00 p.m., Sunday, February 19, 1967, in Confereii-ce Room 4, Building 31, National Institutes of Health, Bethesda, Maryland. Dr. William H. Stewart, Surgeon Ceiieral., Public Health Service, and Chairman, ex officio, presided. The Council members present were: Dr,, Leonidas H. Berry Dr. Edmund D. Pellegrino Dr. Michael E. DeBakey Dr. Alfred M. Popma Dr. Bruce W. Everist Dr. Mack I. Shftuholtz Dr. John R. Hogness Dr. Cornelius H. Traeger Dr. Clark H. Millikan The Council members absent were: Dr, James T. Howell Dr. George E. Moore Public Health Service members Attending some of the sessions included: Mr. Arthur Bissell, Office of the Surgeon General Dr. Wilfred D. David, National Center for Chronic Disease Control, Bureau of Disease Prevention and Environmental Control Dr. Clarence A. Imboden, National Center for Chronic Disease Control, Bureau of Disease Prevention and Environmental Control Dr. Paul Q. Peterson, Bureau of Health Services Dr. Marjorie P. Wilson, National Library of Medicine Proceedings of meetings are restricted unless cleared by the Office of the Surgeon General. The restriction relates to all material submitted for discussion at the meetings, the agenda for the meetings .the supplemental material, and all other official documents. 2/ For the record, it is noted that members absent themselves from the meeting when the Council is discussing applications: (a) from their respective institutions or (b) in which a conflict of interest might occur. This procedure does not, of course, apply to en blod action6--only when the application is under individual discussion. -2- Liaison members attending: Dr. Murray M. Copeland, NCI Council Dr. Edward W. Dempsey, NIGMS Council Dr. John B. Hickam, NHI Council Dr. A. Earl Walker, NINDB Council Others attending: Miss Carolyn Casper, NIH-OD Mr. L. M. Detmer, American Hospital Association Mr. Frank Ehrlich, NIH-OD Dr. Robert L. Ringler, NIH-NHI Miss Machele A. Snyder, General Accounting Office Miss Pauline Stephan, NIH-NCI Dr. Ken Surrey, NIH-DRG Mr. David Wright, NIH-FMB DI*IP Staff: Mr. Stephen J. Ackerman, Chief, Planning and Evaluation Branch Mr. James Beattie, Chief,Grants Management Branca Director for Communications Mr6 Edward Friedlander, Assistant to and Public Information Mr. Charles Hilsenroth, Executive Officer Mr. James D. Lawrence, Financial Management Officer Dr. William D. Mayer, Associate Director for Continuing Education Mr. Maurice E. Odoroff, Assistant to Director for Systems Arid Statistics Mrs. Martha Phillips, Acting Chief, Grants Review Branch Dr. Margaret H. Sloan, Chief, Program Development and Assistance Branch Mr. Storm H. Whaley, Associate Director for Organizational Liaison Mr. Karl D. Yordy, Assistant Director Miss Rhoda Abrams, Planning and Evaluation Branch Mr. Ira Alpert, Program Development and Assistance Branch Mr. Robert C. Anderson, Program Development and Assistance Branch Mr. Nick Cavarocchi, Grants Management Branch Mr. Larry Coffins'Grants Management Branch Miss Cecelia Conrath, Continuing Education Branch Dr. James Dyson, Continuing Education Branch Mrs. Mary Geisbert, Program Development and Assistance Branch Dr. John Hamilton, Program Development and Assistance Branch Dr. John G. Hazen, Program Development and Assistance Branch Dr. Frank Rusted, Continuing Education Branch Dr. Philip A. Klieger, Program Development and Assistance Branch Dk, James A. McA'Nulty, Program Development and Assistance Branch Dr. Robert M. O'Bryan, Program Development and Assistance Branch Dr,.George Retholtz, Grants Review Branch @Irs. Jessie P. Salaz,:-r. ",rants c Mr. Daniel Zwick, Planning and Evaluation Branch -3- I. CALL TO ORDER AND OPENING RFYARKS Dr. William H. Stewart, Surgeon General, PHS, called the meeting to order at 8:10 p.m., and then turned the meeting over to Dr. Marston.- II, ANNOUi@CE@fENTS Dr. Marston made general announcements about the Service Desk and luncheon arrangements. Also, he read the statements on, "Conflict of Interest, " and, "Confidentiality m-f Meetings." The four new Council members, Drs. Hogness, Pellegrino, Popma, and Shanlioltz, were introduced. Also introduced was the new-liaison representative from the National Advisory Council on Neurological Diseases and Blindness, Dr. A. Earl Walker, Professor of Nett-vol.np-ie.-il- Surgery, The Johns Hopkins University, Baltimore, MarylaiLid, Dr. Mary I. Bunting has resigned from the Council due to her heavy commitments. She asked that we express her pleasure in working with this Council in getting the program started, and her continued interest in the program. The sudden passing of Dr. Harry P. Roberts, a member of our staffi was announced. The Council asked Dr. Marston to express its condolences to Mrs. Roberts and the family4 Subsequently, the following letter was sent to Mrs. Roberts: "lirs. Harry F. Roberts and family March 6. 1967 14102 Parkland Drive Rockville, Maryland 20853 Dear Mrs. Roberts: The National Advisory Council on Regional Medical Programs at its February 1967 meeting was informed of the passing of Dr. Roberts. Just prior to adjournment of this meeting individual members-of the Council asked that the minutes show that among the more pleasart and informative activities they had experienced during the past year was the opportunity to work with your husband. both formally and informally. The Council, then, as a whole, instructed me to express its condolences to you and your family. They specified that you be informed of their deep appreciation for Dr. Robertst contributions to the Council and to this new program. Sincerely yours, Associate Directors NIH, and Director, Divigioaof Regional Medical Progrtms" -4- III* CONSIDERATION OF FURURE MEETING DATES Vie had contemplated the need to have a special Executive Meeting of the Council on April 3, 1967, to discuss the report to the President and Congress as required by Section 908 of P.L. 89-239, and to obtain Council input prior to the development of the final draft of the report. The Council agreed that instead of having an'Executive Meeting that the final draft of the report could be handled by mail. In this connection, it was noted that four members of the Council, Drs. DeBakey, Everist, Howell, and Pellegrino, ate members of the ad hoc Committee which is working on the report. The April 3 meeting was, therefore, cancelled. The Council approved the following dates for future meetings: May 21, 1967 (8:00 p.m.) Ma 22-23, 1967 (9:00 a.m.) y August 27, 1967, (8:00 p.m.) August 28-29, 1967 (9:00 a.m.) November 19, 1967 (8:00 p.m.) November 20-21, 1967 (9:00 a.m.) IV. CONSIDERATION OF MINUTES OF NOVEMBER 1966 MEETING The Council unanimously recommended approval of the Minutes of the November 27-29, 1966, meeting as written. V. PROGRESS REPORT ON, "SURGEON GENERAL'S REPORT TO CONGRESS" A progress report was made on the activities concerning the development of this report. The ad hoc Advisory Committee, which is working on the report, has two more meetings scheduled before submitting the final report. The Council members will be consulted prior to the completion of a final draft of the report, after the ad hoc Advisory Committee completes its recommendations, VI. COMMENTS FROM LIAIS014 MEMBERS Dr. Dempsey reported on some of the activities which have been goin.0 on in the National Institute of General Medical Sciences There is an area of biomedical engineering which NIGMS is interested in furthering, particularly at the level of basic research in the development of monitoring systems, in the development of prosthetic activities, and in the areas of computer utilization. Since all of these are areas in which the programs involved in the Regional Medical Programs require some relationship, it is believed that knowledge and collaboration are possible. -5- Recently, NIGMS was part sponsor at a conference of comparative pharmacology in which activity in the field of drug effectiveness, utilization mechanisms of drug action, particularly species differences in drug action, were considered. This has considerable future relevance to some of the things in which the Regional Medical Programs will be involved. Another prooram in NIG14S, in collaboration with the Child Health Institute, which will be of importance to the Regional Medical Programs, as well as to the Heart and Neurology Institutes, is a joint enterprise in the support of a series of studies to determine the developmental stages of a variety of congenital defects. This is in the formative stages at the present time. The NIGMS Council would like to see some attention given to ways in which provisions for research activities can be built into the Regional Medical Programs from the beginning. It is believed that in the original concept of the regional programs they could provide facilities and resources in which research can be done without having to provide the direct funds for accomplishing the research out of funds available through this program. Drs. Copeland, Hickam, and Walker had no comments to make on behalf of their Councils. VII., REPORT ON ALL APPLIC&TIONS WHICH WERE CONSIDERED AT THE NOVEMBER COUNCIL MEETING The following actions have been taken: AWARDED Application Number ion 1S02 RM-00040-01 Col6rado-Wyoming IS02 RiM-00041-01 Western Pennsylvania IS02 RM-00043-01 Indiana 1S02 RYi-00044-01 Maryland 1S02 P&I-00045-01 West Virginia 1S02 RM 00046-01 Georgia IS02 RM-00047-01 Nebraska IS02 RM-00048-01 Ohio Valley 1S02 RM-00049-01 Virginia 1S02 RM-00050-01 Syracuse 3S02 Rlq-00006-OlSl North Carolina 1S02 RM-00021-01R Northlands (Minn6sota) 1S02 RM-00026-OIR Alabama 1S02 RM-00033-01R Louisiana 1S02 P,@LM-00035-OIR "qouth C@,iroll!la -6- RETURNED FOR REVISION Application Number Region I S02 RM 00042-01 New Jersey Ohio 1 S02 RM 00022-01R 1 S02 RM 00024-01R Florida DISAPPROVED 3 S02 RM 00007-OlSl Texas FOTLMI-UP DISCUSSION ON CONTRACTS ake a A proposal from the American College of Surgeons to undert study of the mechanisms for developing a list of centers with outstatiLiing diagnostic treatment and training capabilities in the field of cancer had been discussed at the November 1966 Council meeting. This study would provide assistance in carrying out the purposes of Section 907 which calls for the Surgeon General to develop such lists in the fields of heart disease, cancer, and stroke. At the time of discussion, the Council felt that the application was too brief, that the methods to be followed were not.spelled out adequately, and that the budget was excessive in light of the justification given. This was, therefore, communicated to the American College of Surgeons, and a revision was submitted. The Division of Regional Medical Programs, on the basis of discussion and favorable recommendation by the Council, will pursue more detailed negotiations of the contract. Another proposal which had been discussed at the November Council meeting was a contract for A task force and regional diagnostic and treatment centers in the area of choriocarcinoma. The Council, in November, bad given its general approval to this activity. However@ in further discussion, realizing that one such laboratory was already being supported by the Cancer Control Program, the Division of Regional Medical Programs held discussions with the National Center for Chronic Disease Control. An agreement was reached that this was an appropriate activity for the Cancer Control Program to carry out, and the Cancer Control Program agreed to extend its.support beyond the initial labora- tory already supported. Further, it was agreed that it would be more reasonable to have the National Cancer Institute provide support for all of the clinica tr als activities involved in the choriocarcinoma program, and to have the Canter Control Program provide support for all of the laboratories involved in this program. The Division of Regional Medical Programs, therefore, will not be involved with supporting this activity, exce t in the area of p -7- continuing education of physicians regarding the availability of these services and the need to utilize these services for all patients whqre the possibility of choriocarcinoma is indicated.- IX. CONSIDERATION OF OPERATIOQAL GRANT APPLICATIONS I S03 RM-00002-01, Universitv of Kansas Medical Center A joint site visit was made by representatives of Council, Review Committee, and Staff in November. This provided an opportunity to obtain first-hand a feeling for operational activities proposed and problems related to the region. The Council agreed with the recommendation of the Review Committee that this is an area with considerable experience in cooperative Arrangements, and would be favorable toward the development of a strong regional medical program. There was consensus that a reduction in amounts would not jeopardize the program, and the applicant could easily restructure its priorities within the recommended $1 million (+ or - 10'/.). The Council recommended that the advisory group be broadened to include representation from minority groups. The amounts requested were: $2,521,177, first year; and $2,450,000, second year, plus appropriate indirect costs. Approval was recommended by the Council in the amount of $1 million (-,- or - 10%) for the first yeari Two additional years are recommended for approval, but with the Amounts to be negotiated at the time of renewal at around the figure recommended for the first year. These amounts are in addition to indirect costs. 1 S03 RM-00004-01, Albany Ifedical College of Union Univ New York Prior to the presentation of this application to full membership of Council, a site visit by representatives of Council, Review Committee, and Staff was made to Albany on November 7, 1966. The overall program was judged to be sound and the regionts past experience with the concept of a regional medical prbaram strengthened the recommendation to the reviewing groups that the proposal has much merit and promises The amount recommended by the Council to be awarded for the first year is $750,OOQ (@- or - 10% subject to staff negotiation), plus appropriate indirect costs, and the additional two years are to be negotiated at the time of renewal at around the figure recommended for the first year. The amounts requested were: $1,126,435, first year (includes direct costs for specific pilot projects and other general support) and excludes amount the applicant Dro-oses to transfer from their planning grant; ve,,ar, plus iv-d4rect c6stn. -8- 1 S03 RM-00009- sl. and 3 S03 RM-00009-OIS2) Univer Of q icine A three-year planning grant was awarded to the Missouri Region on June 9, 1966. The,first operational grant application, consisting of three pilot projects, was submitted on October 1, 1966. The two supplemental applications were submitted later. The application was considered at the November Council meeting following a site visit. The Council was encouraging and instructed Staff to proceed with a more detailed analysis of the application. Council recommends that the Advisory Committee needs to broaden its representation to include the Negro community, such as the National Medical Association and the Lincoln University of Missouri., Also, the involvement of the Ellis Fischel Hospital in Columbia needs,to be clarified. Council recommends approval in the amount of $2.5 million (+ or - 107. subject to staff negotiation) for the first year, plus appropriate indirect costs4 Two additional years are recommended for approval, with amounts to be negotiated at the time of renewal at around the amount recommended for the first year. The amounts requested for each year were: $3,249;261, first year; $3,754,614, second year; and $1,787,526, third year, plus appropriate indirect costs. Dr. Mayer absented himself. Dr. Berry abstained from voting. 1 S03 R@1-00015-01, Utah, Intermountain Regional Medical Prograamm A site visit by representatives of Council and DRMP Staff was made in November after the application was evaluated by the Review Committee. Council recommends approval. The affirmative action on #10 is conditional pending satisfactory evidence from a technical committee, made up in consultation with the National Heart Institute, as to the techniques of evaluation of the program, and justification of the cost by experts in the biomedical application of computers and computer techniques. It is anticipated that the grant will be awarded in two stages; first a grant of $820,000. Following additional review and a site visit for the computer based physiological monitoring (requested $929,000), it is anticipated that an appropriate award will be made. The amounts requested were: $1,853,689, first year; $1,221,913, second year; and $809,521 third year. X. CONSIDERATION OF PLANNING GRANT APPLICATIONS I S02 RM-00051-01, University of Tennessee Co The Council recommends approval after staff contact to assure compliance with the following condl.i--ons: 1. Inclusion ol-: i.@-iluority groups on advisory gruup; 2. The core staff seems to be drawn totally from the medical center, but should be broadened to include the periphery; 3. There needs to be involvement and representation of Negro doctors in the participating hospitals; and 4. There is a need for involvement of voluntary agencies in the regional Planning. With the exception of some phases of the application such as the portion requesting funds for renovation and the concerns outlined above, the application was considered to be well thought out and shows much promise for a viable regional medical program. The amounts requested were: $155,056, first year; $148,600, second year; and $73,100, third year, plus appropriate indirect costs. Dr. Berry abstained from voting. 1 S02 r\M-00052-01, Universitv of Arl