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NATIONAL ADVISORY COUNCIL
. ON
REGIONAL MEDICAL PROGRAMS

Subcommittee to Consider Implementation
of Section 910 - Grants for Multiprogram Services

The Subcommittee met at 8:30 a.m. on July 12, 1969, in the Board Room
of the Clinical Center at the National Institutes of Health. All appointed

members were present:

Dr. John R. Hogness, Chairman
Dr. Clark H. Millikan

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 Heart Institute

RMPS Staff members present:

Dr. Donald R. Chadwick, Deputy Director
Mrs. Martha L. Phillips, Associate Director for Grant and Contract Policy

Dr. Richard F. Manegold, Associate Director for RMP Operations and Development
Dr. Samuel Fox, III, Chief, Heart Disease and Stroke Control Program

As a result of its deliberations, the Subcommittee presents to the National
Advisory Council the following recommendations:

Project Grants for Multiprogram 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 not 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 circumstances of the present legislative authority
and the current budgetary limitation, support of activities
in the 55 Regional Medical Programs must be given the first
priority. To the extent that Multiprogram Services can be
funded it is important to recognize and consider them in two
major categories, depending on the source of the initiative
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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
innovations 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.
(This 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 veen rejected previously, on
the basis of scientific merit, as a part of a single
Regional Medical Program application.

Among projects arising fromthe 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;

Top 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 Multiprogram Services grants should follow
essentially the same process 4s currently employed for Regional
applications. Applicants should be advised to be in communications
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 experts
including, in some instances, the staff and consultant representatives
of the appropriate National Institute of Health (see discussion of
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Section 910 Meeting

Clinical Field Trials) and then forwarded to the RMP Review
Committee with their assessment. The application is then to

be submitted to the National Advisory Council on Regional
Medical Programs with the recommendation of the Review
Committee and, where appropriate, a statement from 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 of the study subjects.

Grants under Section 910 for clinical field trials which meet the
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 Regional
Medical Programs to be involved in the trials.

III. In response to the request for recommendations for the preliminary
disposition of the two proposals for the study of the Clofibrate
(#910-5, California Regional Medical Program and #910-5A, University
of Southern California), the subcommittee agreed that neither is
appropriate for support under Regional Medical Programs since they
do not fulfill either of the criteria recommended above.

The biological investigation of the mechanism to be
studied is not yet satisfactorily completed and sufficient
information is available to indicate that additional
primary work needs to be done on the possible toxic

side effects of the drug itself.

Neither is directed toward the trial of a system of cooperative
arrangements to improve the care of the patient involved.

August 12, 1969