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UIDELINES
REGIONAL MEDICAL PROGRAMS

HEART DISEASE, CANCER, STROKE,
AND RELATED DISEASES

 

 
DISCRIMINATION PROHIBITED

Section 601 of Title VI of the Civil Rights Act of
1964, 42 USC 2000d, provides that no person in the
United States shall, on the ground of race, color,
or national origin, be excluded from participation
in, be denied the benefits of, or be subjected to
discrimination under any program or activity receiv-
ing Federal financial assistance, Regulations
implementing the statute have been issued as Part
80 of Title 45, Code of Federal Regulations. The
regional medical programs provide Federal financial

assistance subject to the Civil Rights Act and the

regulations.

Each grant for construction is subject to’ the as
condition that the grantee shall comply with the
- requirements of the Executive Order 11246, 30 F, R.
12319 and the applicable rules, regulations, and

procedures as prescribed by the Secretary of Labor.

 

 

 

 

 
GUIDELINES

REGIONAL

MEDICAL PROGRAMS

Division of Regional Medical Programs
National Institutes of Health
Bethesda, Maryland 20014
U.S. DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE
Public Health Service

July 1966
 

GUIDELINES

TABLE OF CONTENTS

CONTENTS AND USE OF THIS GUIDE

PAGE
I. HISTORY AND PURPOSES OF REGIONAL MEDICAL PROGRAMS 3
p II. COMPOSITION OF A REGIONAL MEDICAL PROGRAM 13
III. POLICIES AND DEFINITIONS ° 23
IV. GENERAL GRANT INFORMATION 35
V. PREPARATION AND REVIEW OF APPLICATION 49

EXHIBIT

 
Lii

 

CONTENTS AND USE OF THIS GUIDE

 

 
 

CONTENTS AND USE OF THIS GUIDE

This Guide is for use in applying for support under Title IX of
the Public Health Service Act (Public Law 89-239), which authorizes
grants to assist in planning, establishing, and operating Regional
Medical Programs to combat Heart Disease, Cancer, Stroke, and related
diseases. It is therefore intended to be used for both planning and
operational grant applications.

The contents of this Guide include the history and purposes,
composition, policies and definitions and general information regarding

the preparation and review of applications for a Regional Medical Program.

 
 

The provisions of this Guide are intended to carry out the purposes
“and objectives of the authorizing legislation, consistent with overall
policies of the Department of Health, Education, and Welfare and sound
fiscal procedures. These provisions must be interpreted in light of

the basic objectives of the program, and the clear intent of the Congress
to stimulate initiative and innovation at the regional level in planning
and implementing regional programs that are fitted to the needs and
resources of the region.

Yf the applicant believes there is a conflict between the pro-
visions of the Guide and the effective implementation of the proposed
program in his region, he is encouraged to consult with the staff of
the Division of Regional Medical Programs. This is a new program in an

exploratory phase. It is expected that policies and procedures will

>

 
 
vi
evolve with time as both the applicant and the Division learn from 6
actual planning and operational experience. As with all statements of
policy and procedure, the Guide attempts to strike a balance among
desirable and necessary procedures. The Division encourages diversity
and innovation in the development of the Regional Medical Program. But
this flexibility of approach must take place within the boundaries of

the legislative authority, applicable general policies, and the necessary

accountability for public funds.

ae

{4

 

 
 

I. HISTORY AND PURPOSES OF REGIONAL MEDICAL PROGRAMS

 

 
 

I. HISTORY AND PURPOSES OF REGIONAL MEDICAL PROGRAMS

The impetus for the Regional Medical Programs was contained in the
President's 1964 Special Health Message to Congress when he proposed to
establish a Commission on Heart Disease, Cancer, and Stroke "to recommend
steps to reduce the incidence of these diseases through new knowledge
and more complete utilization of the medical knowledge we already have."
In March 1964, 4 Commission of distinguished physicians, scientists,
and informed citizens was appointed to accomplish this task. The
Commission collected information from agencies, groups; and institutions
concerned with these diseases through letters, staff visits, gurveys,
etc., held hearings at which expert witnesses from the widest possible

ange of interests, both public and private, presented their views, and

  
 

Bpmitted a report which included the following points:

"our Nation's resources for health aré relatively untapped. The
rising tide of biomedical research has already doubled our store of
knowledge about heart disease, cancer and stroke...-"

"yet for every preakthrough, there must be follow-through. Many
of our scientific triumphs have been hollow victories for most. of the
people who could benefit from them."

The Commission presented 35 recommendations aimed at reducing the
toll of these diseases through the development of more effective means
of making the latest medical advances available to 4 greater portion of the

population and through the provision of additional opportunities for

research. The major recommendations of the Commission are the basis for

 
-4.

the proposed regional medical programs authorized by Public Law 89-239
(hereafter referred to in this text as "The Act", See Exhibit).

The Act is intended to assist our medical institutions and professions
in capitalizing on the rapid advances of scientific medicine in the pre-
vention, diagnosis, treatment, and rehabilitation of patients afflicted
with heart disease, cancer, stroke or related diseases. To paraphrase
the statement of purposes in the Act, these grants are to encourage and
apsist in the establishment of regional cooperative arrangements among
medical schools, research institutes, hospitals and other medical insti-
tutions and agencies for the purpose of affording the medical profession
and the medical institutions the opportunity of making available to their
patients the latest advances in the diagnosis and treatment of these
diseases, Grant funds will support through these cooperative arrange- €
ments research, training (ineluding continuing medical education) and
related demonstrations of the highest standard of patient care. Through
these means the program is also intended to improve generally the health
manpower and facilities of the Nation, The Act states that these purposes
should be accomplished without interfering with the patterns of professional
practice or hospital administration.

The intent of the Act is built upon the following basic premises and

assumptions:
1. The program will utilize and build upon existing institutions and

manpower yesources,.

2. The active participation of practicing physicians is essential

to the success of a regional medical program,

 

 
   

-5-

 

3. The purposes can best be achieved through initiative, planning,
and implementation at the regional level under conditions which encourage
innovative approaches and programs specifically designed to deal with the

diversity of needs, resources and existing patterns of education and

service,

kh, Cooperation among all essential elements of the health resources
in a region is an essential means of coping with the complexities,
specialization, high cost, manpower needs, and educational and training
needs which are the by-products of the dynamic advances of medical science.
The objectives of the Act will not be achieved by a program which serves
the interests of a single category, institution, or organization. A

basic aim of the program is to overcome fragmentation and insularity.

  

5. In order to insure an effective linkage between research
advances and improved patient care, it is desirable to establish a
continuing relationship among the research and teaching environment of
the medical center, the patient care activities involving the commnity
hospital, and practicing physicians, The impact of research advances on
the development of high quality patient care has typically been most
direct in the university medical centers or other medical centers which
combine extensive research teaching and patient care activities. The
primary benefits of this interrelationship, however, have often been
confined to the medical center itself and affiliated hospitals, A basic
premise of the Act is the desirability of extending this productive
interrelationship to additional hospitals and to practicing physicians

_ through the establishment of regional cooperative arrangements.
=

 
-6-

6. The financing of patient care is not the objective of the regional
medical programs. The payment of patient care costs is limited to those
costs incident to research, training and demonstration activities supported
by these grants.

7. It is assumed that the development of the full capabilities of
a regional medical program will take a number of years. The purpose of
the first three years of legislative authorization is to. encourage and
assist in the planning and implementation of the first steps toward the
establishment of a regional medical program. It is assumed that the
development of a plan and the implementation of the initial elements there-
of will constitute a learning experience which can be utilized in taking
additional steps in the cooperative effort against heart disease, cancer
end stroke. <q

The background against which these assumptions and premises are
set includes a nimber of trends and influences which have been affecting
the nature of medical service, education, and research for some er
The opportunities created by the impact of science on modern medicine
have already been mentioned, Along with the creation of opportunities,
however, the increasing impact of science has changed the nature and
shape of modern medicine, raising a number of situations which are very
aifficult to manage y including increased. specialization, increasing
complexities and costs of diagnosis and treatment, and the difficulties
in transmitting a rapidly expanding body of knowledge. The tremendous
growth of knowledge through large seale research efforts is a charac.
teristic of our times, not just in medicine but in most aspects of our

ane atu Wharnatvan +h4o nhanemoanan dae anne fe aed Mew AE Be it @

 
g

of new means of coping with steady and dynamic change if the benefits
of the knowledge are to be realized.

The forces of change can be viewed as part of a continuum existing
over many years, rather than a revolutionary or radical alteration of current
patterns. This trend calls for the development of Regional Medical Programs
whith create an effective environment for continuing adaptation, innovation,
and modification. The development of a great medical research effort
is the product of a deliberate national policy to stimulate and support
the development of new medical knowledge af a rapid rate. The passage
of the legislation authorizing Regional Medical Programs represents a
corresponding commitment to assist the development of necessary measures
to bring the benefits of this new knowledge to the patient in the field

3. heart disease, cancer, stroke, and related diseases.

The process of medical education in all its aspects has also been
undergoing a change under the impact of the growth of knowledge. The
development of great medical centers built around education, research,
and high-quality patient care has taken place throughout the Nation.

The consequence of rapid expansion in the body of medical knowledge is
increased specialization, resulting in the prolongation of the educational
process. A continuing process of education throughout the career of a
physician is therefore of great importance.

The continued evolution of medical education and the growth of
the medical centers carries with it increased problems in maintaining
an effective linkage between the medical center and the practicing

eo" Recent reports have emphasized the need for those concerned

 
- 8 - r
with medical education to assume responsibilities in meeting
national needs for improved health care. It has become clearly apparent
that the medical center represents an indispensable resource for improving
health in its area of influence. In the environment of medical education,
new attention is being given to the need to cope effectively with the
problems brought about by the developments in modern scientific medicine.

| Many medical leaders are stressing that those involved in health
care must maintain a continuous relationship to the educational process and
that medical schools and hospitals should have an increasing involvement
in the process of continued learning. The very forces that have tended
to separate thk centers of medical knowledge from the practicing physician
are creating an ever greater need to bring physicians into continuing
contact with the environment of teaching and research. <q

Another trend is usually described as the regionalization of medical

services. There have been numerous regionalization proposals during
the past 35 years and efforts have been made to implement various approaches

to regionalization. The concept of Regional Medical Programs includes

 

the regional approach to the provision of highly specialized services
involved in the diagnosis and treatment of heart disease, cancer, stroke,
and related diseases. The legislation provides a very flexible framework
for the implementation of a regional approach which is appropriate to the
voluntary nature of our medical institutions.

The Regional Medical Programs present the medical interests within
a region with an instrument of synthesis that can capitalize on and

reinforce the various trends and resources seeking to make more widely 4
® ~
diseases, It is the interaction of these trends at this time, rather
than an abstract conceptualization which not only justifies but requires
a synthesizing force such as the Regional Medical Programs. The Regional
Medical Programs represent a general concept, rather than a specific
blueprint. The opportunity is presented to go beyond concept into spe-
cific planning and implementation of programs which represent pragmatic
steps toward the achievement of the overall goals of the legislation.
It is an opportunity to mix creative ideas and specific actions in

developing improved means for advancing the health standards of the

American people,
II.

- ll -

COMPOSITION OF A REGIONAL MEDICAL PROGRAM

Definition of a Regional Medical Program

The National Advisory Council on Regional Medical
Programs

Categorical Emphasis —
The Region

Cooperative Arrangements Among Resources Within The
Region

Interregional Cooperation
The Regional Advisory Group

Relation of Regional Medical Programs to Programs of
Other Health Agencies

Page

13

13
14

15

15
16

17

18

 
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II. COMPOSITION OF A REGIONAL MEDICAL PROGRAM
A. Definition of a Regional Medical Program

The Act defines a regional medical program as a cooperative
arrangement among a group of public or private nonprofit institutions
or agencies engaged in research, training, diagnosis, and treatment
relating to heart disease, cancer, or stroke, and at the option of

the applicant, related disease or diseases; but only if such group

 

1. is situated within a geographic area, composed of any
part or parts of any one or more states which the |
Surgeon General determines, in accordance with regulations,
@ to be appropriate for carrying out the purposes of the Act;
2. consists of one or more medical centers, one or more
clinical research centers, and one or more hospitals; and
3. has in effect cooperative arrangements among its component
units which the Surgeon General finds will be adequate

for carrying out effectively the purposes of this program.

B. The National Advisory Council on Regional Medical Programs
The National Advisory Council on Regional Medical Programs
consists of the Surgeon General, who is the chairman, and 12 members,
not otherwise in the regular fulltime employ of the United States,

who are leaders in the fields of the fundamental sciences, the medical

sciences, or public affairs, In particular, one of the twelve council
~ e

members must be outstanding in the field of heart disease, one in
cancer, and another in stroke, and two must be practicing physicians,
The role of the Council is to advise and assist the Surgeon General

in the formulation of policy and regulations regarding the regional
medical programs, and to make recommendations to him concerning approval
of applications and amounts of grant awards. No grant may be awarded

unless it has been recommended for approval by the Council.

C. Categorical Emphasis

The focus of the Regional Medical Programs under the authorizing
legislation is on problems of heart disease, cancer, stroke, and related
diseases. This rather broad categorical approach must be a consideration
in the development of specific program elements under a Regional easel
Program. Heart disease, cancer, and stroke are appropriate targets .
because of their prevalence as killing and disabling diseases. These
diseases present a complex challenge to the research investigatoy and
the advances which are being made require diagnostic and treatment
techniques of great sophistication. Because of the broad scope of heart
disease, cancer, and stroke it would be difficult and perhaps detrimental
to some types of medical services and educational activities if a rigidly
categorical approach were adopted for all relevant program elements.
However, the emphasis of the program does require that the program

elements be shown to have significance for combating heart disease, cancer,

stroke and related diseases.

e

 
~15-

D. The Region

A region is a geographic area composed of part or parts of
one or more states which the Surgeon General determines to be appropriate -
for the purposes of the program. It should be an economically and
socially cohesive area taking into consideration such factors as present
and future population trends and patterns of growth; location and
extent of transportation and commmication facilities and systems; and
presence and distribution of educational and health facilities and
programs. The region should be functionally coherent; it should follow
appropriate existing relationships among institutions and existing
patterns of patient referral and continuing education; it should

_,encompass a sufficient population base for effective planning and

Wise of expensive and complex diagnostic and treatment techniques.

E. Cooperative Arrangements Among Resources Within the Region
It is recognized that the full development of a Regional

Medical Program, which involves potentially all medical institutions,
organizations, and personnel within the region, could take a number of
years in many areas. The program emphasizes the development of
cooperative arrangements which are effective in making the latest
scientific advances in these diseases more widely available. Consid~
erable flexibility is provided for the development of cooperative
arrangements that are appropriate to the needs, resources, and patteris
of the region. The cooperative arrangements should: 1. Encourage a

cooperative attitude and stimulate participation and initiative among
-~ 16 -

e

the program elements; 2. Provide for the necessary decision-making
framework for the activities conducted under the Regional Medical

Program grant; 3. Include administrative and fiscal arrangements,

which provide for adequate program coordination and fiscal accountability;
4. Provide for effective administration of central program elements
which serve the entire region; 5. Include mechanisms for the evaluation
of the effectiveness of the Regional Medical Program, including the
acquisition of uniform data for the use in evaluating effectiveness and
the means to evaluate specific program elements of the Regional Medical
Program; 6. Provide for continual planning and implementation of the

further development of the Regional Medical Program.

F. Interregional Cooperation @

The definition of a particular region necessarily requires con-
sideration of relationships to adjoining regions. Interregional cooper-
ation is to encouraged, especially in program elements where a uniform

_approach is desirable. Some examples where interregional cooperation

 

might be beneficial include: 1. Development of standardized criteria

for data gathering and analysis; 2. Continuing education programs

drawing on the educational resources of more than one region; 3. Referral

of patients for highly specialized diagnosis and treatment not available

in every region; 4. Program planning and coordination between regions.
Regional boundaries should not cut off existing relationships

and patterns and should not operate to the detriment of the objectives

of the legislation.
-17-

G. The Regional Advisory Group

The Act specifies that an applicant for a planning grant must
designate a Regional Advisory Group. The Act also specifies that the
Advisory Group must approve an application for an operational grant under
Section 904. The Advisory Group must include practicing physicians,
medical center officials, hospital administrators, representatives from
appropriate medical societies, other health professions, voluntary
health agencies, and representatives of other organizations, institutions,
and agencies and members of the public familiar with the need for the
services provided under the program. It should be broadly representative
of the geographic areas and of the social groups who will be served by

4g the Regional Medical Program.

@ The Regional Advisory Group should provide overall advice and
guidance to the grantee in the planning and operational program from the
initial steps onward. It should be actively involved in the review and
guidance and in the coordinated evaluation of the ongoing planning and
operating functions. It should be constituted to encourage cooperation
among the institutions, organizations, health personnel, state and local
health agencies, and with the state Hill-Burton agencies. It should be
concerned with continuing review of the degree of relevance of the
planning and operational activities to the objectives of the Regional
Medical Program and particularly with the effectiveness of these
activities in attaining the objective of improved patient care. There-
fore, Advisory Group members should be chosen who will provide a

oe background of knowledge, attitudes and experience.

 
- @

The grantee institution named on the face page of the application
is legally and administratively responsible for the conduct of the
Regional Medical Program. The Advisory Group does not have direct
administrative responsibility for the program, but the clear intent of
the Congress was that the Advisory Group would insure that the Regional
Medical Program is planned and developed with the continuing advice
and assistance of a group which is broadly representative of the health
interests of the region. The Advisory Group, therefore, is an inherent
element of a Regional Medical Program that helps to accomplish the basic
objective of broadly based regional cooperation.

In order to serve these purposes the Advisory Group should
operate under established procedures which insure continuity and @
appropriate independence of function and advice. The Advisory Group
is expected to prepare an annual statement giving its evaluation of

effectiveness of the regional cooperative arrangements established under

the Regional Medical Program,

H. Relation.of Regional Medical Programs to Programs of Other
Health Agencies
An essential function of Regional Medical Programs is to plan
and to provide an environment for coordinating the health resources of
the Nation in order to assure the availability of the best of medical
care to all persons. It is not the intent of a Regional Medical Program

grant to supplant other sources of support for the various program

 

 
- 19 -

Da reser: that are related to achieving its purpose. The Regional Medical
Program provides an opportunity to introduce program activities which
draw upon and effectively link activities already supported, or support-
able in the future, through other sources. Current examples of other
Federal programs that provide essential inputs into the health resources
of the region are: 1. The Bureau of State Services; 2. The Bureau
of Medical Services; 3. The National Institutes of Health, particularly
the National Heart Institute, National Cancer Institute and National
Institute of Neurological Diseases and Blindness; 4. Other constituants
of the Department of Health, Education and Welfare, particularly the
Social Security Administration, the Office of Education, the Vocational
Rehabilitation Administration and the Welfare Administration; and
5. Other government agencies, particularly the Office of Economic
Opportunity and the Veterans Administration. The Regional Medical Program
grants should concentrate on catalyzing and synthesizing efforts in
achieving more effective communication among all of the health related
elements in the region.

New sources of possible support for activities related to the
Regional Medical Programs should also be considered during both the
planning and operational phases. For example, the reimbursement
principles for hospitals and other providers’ of Medicare services should

make available to these institutions additional amounts of capital

funds, which may contribute to accomplishing the objectives of the

 
- 20 -

¢

Regional Medical Programs through a cooperative approach to the use

of medical resources in the region.

In order to assure coordination within the Federal Government,
the Division of Regional Medical Programs is developing an active
exchange of information with these agencies to assure that all pertinent

activities are effectively interrelated.

 
@

III.

- 21 -

POLICIES AND DEFINITIONS

A.

B.

Policies
1. General Responsibilities
2. General Assurances
3. Surveys and Questionnaires
4, Systems Analysis
5. Publications
6, Patents and Inventions
7. Other Public Health Service Grant Policies
a. Clinical Research and Investigation Involving
Human Beings
b. Protection of Individual Privacy in Research
and Investigation -
(1) Administration of Personality Tests,
Inventories or Questionnaires
(2) Investigation of Persons Below the
College Age Level
c. Animal Care
Definitions
1. Approved Program
2. Budget Period
3. Clinical Research Center
4, Construction
5. Grant
6. Grantee
7. Hospital

Page
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28

28

28

28
29
30
30
30
30
30
31
31

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B. Definitions (Continued)

8.

9.

10.

ll.

12.

Medical Center
Non-Profit
Practicing Physician
Program Period

Related Diseases

Page
31

31
31
32

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- 23 -

) .

III. POLICIES AND DEFINITIONS

A. Policies

1. General Responsibilities - The named grantee is obligated, both
for itself and cooperating institutions, to administer the grant in accordance
with regulations and policies of the Division of Regional Medical Programs.
Where a policy is not stated or where the institutional policy is more
restrictive than the Regional Medical Program policy, institutional policy
prevails.

2. General Assurances - Specific attention is directed to the
requirement to honor the assurances provided in the Act.

® The recipient of a planning grant must comply with the assurances

in Section 903 (b), namely:

a. reasonable assurances that Federal funds awarded to any
grantee will be used only for the purposes for which awarded and in

accordance with the applicable provisions of the Act and the regulations

thereunder,

b. veasonable assurances that the grantee will provide for
such fiscal control and fund accounting procedures as are required by the

Surgeon General to assure proper disbursement in the accounting for such

federal funds,

c. reasonable assurances that the grantee will make such
reports in such form and containing such information as the Surgeon General

may from time to time reasonably require, and will keep such records and afford

» such access thereto as the Surgeon General may find necessary to assure the

 
- 24 -

correctness and verification of such reports, and

d. a satisfactory showing that the grantee has designated an
advisory group to advise it (and the institutions and agencies participating
in the resulting regional medical program) in formulating and carrying out
the plan for the establishment and operation of such regional medical program.
The advisory group includes practicing physicians, medical center officials,
hospital administrators, representatives from appropriate medical societies,
voluntary health agencies, and representatives from other organizations,
institutions and agencies concerned with activities of the kind to be
carried on under the program and members of the public familiar with the needs
for the services provided under the program.

The recipient of an operational grant must comply with the assurances

under Section 904 (b), namely: @

a. Federal funds awarded to any grantee (1) will be used in
accordance with applicable provisions of the Act and the regulations there-
under and (2) will not supplant funds that are otherwise available for
establishment or operation of the Regional Medical Program with respect to
which this grant is made.

b. The grantee will provide for such fiscal control as fund
accounting procedures as are required by the Suregeon General to assure
proper disbursement of an accounting for such federal funds.

c. The grantee will make such reports in such form and containing
such information as the Surgeon General may from time to time reasonably require

and will keep such records and afford such access thereto as the Surgeon General

t

 
fz

- 25 -

may find necessary to assure the correctness and verification of such reports,
and

d. Any laborer or mechanic employed by any contractor or
subcontractor in the performance of work on any construction aided by
payments pursuant to any grant under this section will be paid wages at rates
not less than those prevailing on similar construction in the locality as
determined by the Secretary of Labor in accordance with the Davis-Bacon Act,
as amended (40 USC 276a--276a-5); and the Secretary of Labor shall have
with respect to the labor standards specified in this paragraph, the
authority and functions set forth in Reorganization Plan Numbered 14 of 1950

(15FR 3176; 5 USC 133z-15) and section 2 of the Act of June 13, 1934, as

r

amended (40 USC 276c).

6 3. Surveys or Questionnaires - Surveys or questionnaires arising

from and supported by a grant should include a positive statement clearly
setting forth that the contents are in no way the responsibility of the
Public Health Service. |

4. Systems Analysis - This policy statement is to be used by those
applicants who desire to incorporate systems analysis methodologies into
their applications.

The use of systems analysis methodologies in regional medical programs
is encouraged, but only to such an extent as it is considered applicable as
an essential integral component of the individual program proposed by the
applicant. The applicant should emphasize the development of innovative,
adequately formulated studies of realistically restricted problems involving

the application of "systems" methodologies rather than submit an application

 
- 26 - 6

dominated by general proposals for the utilization of large scale "systems"
approaches for the design of a regional medical program.

The Division of Regional Medical Programs will explore through
contracts and selective studies the applicability of systems analysis to
the planning and implementation of a regional medical program. One approach
to the use of systems analysis in current grant applications, within the
framework of this policy, is the incorporation of limited numbers of
personnel with such analytic skills into the planning process. These
personnel may come from university departments or schools of industrial
engineering, schools of public health, commercial systems firms, those
with experience in program planning and budgeting, and a variety of other
sources. It is expected that from such a beginning areas worthy of more -
detailed activity may well become apparent and qualify for subsequent ¢
additional grant support. Applicants are encouraged to direct any
questions they may have relative to the use of systems analysis to the
Division of Regional Medical Programs.

5. Publications - Grantees may publish materials relating to their
regional medical program without prior review provided that such publications
carry a footnote acknowledging assistance from the Public Health Service, and
“indicating that findings and conclusions do not necessarily represent the

views of the Service.

6. Patents and Inventions - The Department of Health, Education and

 

Welfare regulations (945 F.R., Part 6 and 8) provide as a condition that all

inventions arising out of the activities assisted by Public Health Service

 
- 27 -

Devan: must be promptly and fully reported in the Public Health Service. Any
process, art or method, machine manufacture or improvement thereof, may
constitute an invention if it is new and useful and would not have been
obvious to a person having skill in the art to which it relates.

In order-for the Public Health Service to carry out its responsibility
under these patent regulations, it is essential that the Service be advised
before awarding Government funds of any commitments or obligations made by
the institutions or by the professional personnel to be associated with the
activities carried on under the grant which would be in conflict with the
inventions agreement. When submitting an application for Regional Medical
Programs, the grantee must provide in letter form either:

a. a statement indicating no previous commitments or obligations

e* been made, or
~ b. a detailed explanation of such commitments or obligations
where they do exist.

One such letter will suffice for the named grantee and all cooperating
institutions receiving support under the grant. It is the responsibility of
the institution named as the grantee on the application to ascertain the facts
relating to patents and to report these on behalf of all entities participating
in the Regional Medical Program. .

In subsequent years an annual invention statement Form PHS-3945 must
be filed whether or not an invention has occurred. Where there are no
inventions to report, a single form PHS-3945 is all that is required for the
institution named on the application as the grantee and for all cooperating
institutions. Where there are inventions to report, a separate annual

ons statement must be filed for each one. Here again, it is the .
a“ 6

responsibility of the grantee to report on behalf of itself and all other
entities participating in the Regional Medical Program. The Regional
Medical Program grant for the following year will not be issued until the
invention statement form PHS 3945 has been teceived by the Division of
Regional Medical Programs.

7. Other Public Health Service Grant Policies - The following
Public Health Service grant policies are also applicable to any such

activities supported through a regional medical program grant:

a. Clinical Research and Investigation Involving Human Beings -
This policy statement is currently being revised by Public Health Service.
b. Protection of Individual Privacy in Research and Investigation -
(I) Administration of personality tests, inventories or _
questionnaires. No grant or award of the Public Health Service Extramural @
Programs in support of research or investigation involving the administration
of personality tests, inventories or questionnaires shall be awarded by the
Public Health Service unless the application includes a description of the
manner in which the rights and welfare of the subjects are assured, that is,
how their informed consent is obtained or why this consent is deemed
unnecessary or undesirable in the particular instance,
(2) Inyestigations of persons below the college age level.
No grant or award of Public Health Service Extramural Programs in support of
research or investigation involving administration of investigational procedures
to persons below the college age level shall be awarded by the Public |
Health Service unless the application includes a description of the manner

in which the rights and responsibilities are respected, that is, how the “=
}

 
- 29 -

tz

consent of the parents or guardians is obtained, or why this consent is
deemed unnecessary or undesirable in this particular instance.

The professional judgment of the grantee will determine what
constitutes respect for the rights and responsibilities of parents or guardians,
what constitutes informed consent, and what constitutes a validation for
deeming this consent to be unnecessary or undesirable in a particular instance.

c. Animal Care - Each person assigned or appointed to a project
receiving any Public Health Service support is required to exercise
every precaution to assure proper care and humane treatment of research animals.
The booklet, Guide for Laboratory Animals, Facilities and Care (PHS Publication
#1024) should be obtained from the Division of Research Grants, Information
@u« National Institutes of Health, Bethesda, Maryland, 20014.
7 The Public Health Service endorses the following guiding
principles in the care and use of animals:

(1) Animals should be acquired, retained, and used in
compliance with applicable state and local law.

(2) Animals should receive every consideration for their
bodily comfort, be kindly treated and properly fed, be kept in sanitary
facilities, and be provided with suitable medical care. ,

(3) With any operation likely to cause greater discomfort
than that attending anesthetization, the animal should first be rendered
incapable of perceiving pain and should be maintained in that condition until
the operation is ended. Exceptions should be made only when anesthesia would

defeat the objective of the experiment. Im such cases, the anesthesia should

®@
so ‘

be discontinued only so long as it is absolutely essential for the necessary
observations.

(4) I£ the nature of the study requires survival of the
animal, aseptic precautions should be observed during the operation, and
care should be taken to minimize discomfort during convalescence comparable
to precautions taken in a hospital for human beings. If the animal is
severely incapacited and survival is not a requirement of the experiment,
the animal should be sacrificed in a humane manner immediately following

final observation.

B. Definitions
1. Approved Program - An approved program is an identified activity |.

approved by the Division of Regional Medical Programs for support for a

specific period of time. °

2. Budget Period - The budget is the period of time within a
program covered by a specific budget, usually 12 months.

3. Clinical Research Center - A Clinical Research Center is an
institution (or part of an institution), the primary function of which is
research, training of specialists, and demonstrations and which, in connect ion
therewith, provides specialized, high-quality diagnostic and treatment
services for inpatients and outpatients. The clinical research center may
be a part of the medical center or it may be a separate institution.

4. Construction - Construction means alteration, major repair (to

the extent permitted by regulations), remodeling and renovation of existing

 
-31-

@ buildings with prior approval (including initial equipment thereof), and

@

replacement of obsolete, built-in (as determined in accordance with
regulations) equipment of existing buildings.

5. Grant - A grant is the total amount of direct and indirect
costs which is awarded to a grantee for support of an approved peograni
for a specific period of time. -

6. Grantee - The grantee is the applicant institution who is named
on the face page of the application and who assumes responsibility for the grant.

7. Hospital - The term "hospital" includes general, tuberculosis,
and other types of hospitals, and related facilities, such as laboratories,
out-patient departments (nurses’ home facilities), central service facilities
operated in connection with hospitals, and other health facilities in which
local capability for diagnosis and treatment is supported and augmented
by the program established under this Act. It does not include institutions
furnishing primarily domiciliary care. Proprietary hospitals may participate
in the Regional Medical Program but may not be funded under the Act.

8. Medical Center - Medical Center is a medical school or other
medical institution involved in postgraduate medical training and one or
more hospitals affiliated therewith for teaching, research, and demonstration
purposes.

9, Non-Profit - Non-profit as applied to any institution or agency
means an institution or agency which is owned and operated by one or more
non-profit corporations or associations no part of the net earnings of which
inures, or may lawfully inure, to the benefit of any private shareholder

or individual.

10. Practicing Physician - A practicing physician is any physician

 
~ ¢

11, Program Period ~ The program period is the time for which new

licensed to practice medicine in accordance with applicable state laws.

or continuing support has been recommended. The initial grants may be for

any period up to June 30, 1969,

12. Related Diseases ~ Related diseases are those diseases which

can reasonably be considered to bear a direct relationship to heart disease,

cancer or stroke.

 
- 33 -

e

IV. GENERAL GRANT INFORMATION Page
A. Types of Grants | | 35
1. Planning 35
2. Operational 35
3, Supplemental 35
B. Relationship of Planning Grant to Operational Grant 36
C, Eligible Activities , 37
1, Under a Planning Grant .
(including Feasibility Studies) 39
2. Under an Operational Grant | 40
a. Continuing Education and Training 40
b. Research . 42
@ c. Demonstration of Patient Care 42
d. Support of Administrative Core 42
e. Alteration and Renovation 43
£. Communication Systems 43
g. Communications and Public Information » 43
h. Computers 44
i. Diagnostic and Treatment Equipment 44
j. Support of Staff in Cooperating Institutions a4
k. Consultant Services «AAA
l. Transportation of Patients 44A
D. Relationship to Other Sources of Support 44A
E. Single Grant Approach 44B

 
- 35 -

Z
If:
AS

IV. GENERAL GRANT INFORMATION
A. Types of Grants
~ 1. Planning - Section 903 of the Act authorizes the Surgeon
General, upon the recommendation of the National Advisory Council on
Regional Medical Programs, to make grants to assist in the planning and

development of Regional Medical Programs.

2. Operational - Section 904 authorizes the Surgeon General,

also upon recommendation of the National Advisory Council on Regional
Qu Programs, to make grants to assist in the establishment and

operation of the Regional Medical Programs. The initial authorization

of this program through fiscal year 1968 indicates that operational

grants under Section 904 will be considered pilot projects for the

establishment and operation of Regional Medical Programs. The designa-

tion of operational programs as pilot projects emphasizes the exploratory

nature of the first period of authorization.

3. Supplemental - The exploratory and developmental aspects
of a Regional Medical Program, both in the planning and operational phases,

lead to the expectation that the grantee will wish to add additional

 
- 36 -

program elements or to expand existing program elements subsequent to
the award of the initial grant. The practice of submitting requests

for supplemental funds is encouraged insofar as the submission of a
supplemental request is preferable to the inclusion in the initial
application of program elements which represent only very preliminary
ideas or for which it is difficult to justify particular budget requests.
Supplemental grant requests will be submitted on the same form as the
initial application and will go through a similar review and award

process.

B. Relationship of Planning Grant to Operational Grant ¢

The Act does not provide a specific sequential relationship
between planning grants under Section 903 and operational grants under
Section 904. The operation of a Regional Medical Program obviously
should be based upon sound planning. For example, one purpose of
planning for a region is to help establish the geographic boundaries
that are necessary for effective and efficient operation of the region.
Planning also provides an opportunity for the advisory group to participate
in the initial stages of the program. In some areas of the country, much
relevant planning may have taken place before passage of this legislation.
In such instances the grantee may request an operational grant without

having first applied for a planning grant under Regional Medical Programs.

 
- 37 -

@ A grantee who has received a planning grant need not wait for the

completion of that planning grant before applying for an operational

grant under Section 904. The grantee may wish to request funds under
Section 904 to finance operational activities which represent the

first elements of a complete Regional Medical Program. Such grants for

the partial implementation of a Regional Medical Program will be awarded,
however, on the condition that the planning for implementation of additional
phases of the Regional Medical Program will proceed, Grants for partial
implementation will be awarded for limited time periods and the continuation
of such a grant will be conditioned upon the submission, review, and
approval of additional elements of the complete Regional Medical Program

by the end of the initial period of award. The purpose of these conditions

o to allow initial steps in the implementation of a Regional Medical Program,

IF while at the same time, insuring progress toward the full development of

he

the Regional Medical Program.

Planning should continue after the initiation of an operational
program under Section 904. This continued planning may be financed either
by continuing the planning grant under Section 903, or by the inclusion
of the support of planning activities under the operational grant.
Conversely, however, operational activities may not be supported from

planning grant funds.

C. Eligible Activities
This section gives examples of types of activities which would be

eligible for support under a Regional Medical Program grant. The intent

of the program is to encourage innovations and creativity in the

Qe through cooperative efforts of program elements to be included

 
- 38 -
in the Regional Medical Program. The listing therefore is intended to be ¢
helpful in the understanding of the scope of a regional medical program,
rather than to be definitive.

Many different types of activities can be supported under a Regional
Medical Program grant. Special attention must be given to the functional
interrelationships among the various program elements, and how they relate
to the goals of the Regional Medical Program.

Certain program elements deserve special discussion. Applications
for a Regional Medical Program grant, both planning and operational, must
include specific reference to program plans for education and training
of health personnel. Continuing education should receive particular
emphasis as an integral part of the total Regional Medical Program.
However, meritorious programs of continuing education presented in the
absence of, or unrelated to, plans for the fuller development of a Regional
Medical Program cannot be supported through grants under this program.
Therefore, the relationship of continuing education to other aspects of
the proposed planning or operational activity must be indicated.

Both the planning and operational phase of a Regional Medical Program
should stress the development of more effective relationships between
ongoing research activities in the fields of heart disease, cancer,
stroke, or related diseases and the other proposed activities of an
educational or service nature under the Regional Medical Program, The
Regional Medical Program should seek to maintain an effective interaction
between ongoing research activities and other aspects of the Regional
Medical Program, so as to assure that the activities specifically directed

toward the goal of improved diagnosis and treatment may receive the benesite@),

 
- 39 -

of future research advances.

.1. Under Planning Grant (including Feasibility Studies) The scope
of planning activities which are related to accomplishing the objectives of
the Regional Medical Programs can be quite broad. However, planning and
conceptualization concerned with general health matters but not related to
development of a Regional Medical Program should not be included.

In general, planning should include studies of resources, distribution
of services, patient flow, and program elements that are needed, design of —
specific program elements that includes a mechanism for program evaluation,
planning for cooperation among institutions, and planning toward the more
effective distribution and utilization of all types of medical resources.

The development and operation of regional medical programs, individually

@-. collectively, can be aided by well conceived, properly implemented, and
continuous commnication and public information techniques and activities
which are designed to provide a maximum of understanding, participation and
support among cooperating organizations and individuals, as well as among
lay publics for whom the programs will be established.

To plan and implement such activities, provision for including profes-
sional staffing and budgetary support for a communication and public information
component may be included in grant applications.

The emphasis on continuing education in the Act deserves particular
mention. Creative approaches in the development and management of
cooperative arrangements to achieve high quality education programs as well

as new ways of applying educational research findings are vital. Indeed the

 
- 40 -

¢

history of the legislation itself stimulates this aspect of regional medical
programe.

Examples of activities for consideration in planning in the area of
continuing education and training are: identification of existing
educational and training programs within the region; evaluation of additional
educational and training needs in the region; projections of methods of
meeting those needs including specification of appropriate curriculum
content, etc,; preliminary thoughts relative to the mechanism of evaluating the
effectiveness of future programs in meeting the needs; the relationship of
continuing education and training programs. to the overall objectives of the
Regional Medical Program including their anticipated effectiveness in bring-

ing about cooperative arrangements between the various health institutions and

personnel within the region, q

2. Under an Operational Grant - Pilot projects for the establishment
and operation of a Regional Medical Program can cover a great variety of
activities,

ae Continuing Education and Training - It is assumed that before

applying for an operational grant in this area, certain activities will
have been undertaken during the planning process (see above). Operational
grant funds can support costs of programs including teaching staff,
equipment, educational materials, transportation, rental or renovation
of space and related demonstrations of patient care. However, the grant
may not supplant previous support for ongoing activities in this area.
Documentation of the additive nature of the proposed program should be

N
made, Stipends for trainees and participants in the program will be <é
-~ 41 -
@
considered only when it is fully documented that such funds are not available
from other sources and their expenditure is absolutely necessary for the
implementation of the program.

In instances where major expenditures for equipment and supplies are
requested special emphasis should be given to measurement of effectiveness of the
program including measurements in change in performance of participants, numbers of
participants, and degree information produced might be applicable to other
regional medical programs. There should also be acknowledgement of related
efforts already accomplished by others with indications of how proposed
project will extend those efforts. It is anticipated that such major invest-
ments for equipment and supplies will more appropriately be in pilot projects

_or operational grants rather than in feasibility studies or planning grants.

Considerations under the Regional Medical Programs will be given to
continuing education and training programs for medical, allied health
personnel and associated professions. However, it should be emphasized
that the primary intent of the legislation in this area is the support of
those activities that are beyond those normally accepted as basic preparation
for work in the health field. Thus, support of basic programs in medical
education, residency training, and basic education and training in allied
health areas is not normally anticipated. If, however, the applicant
can demonstrate that funds are not available from other sources and the
particular basic educational program is essential to the success of the
Regional Medical Program then consideration will be given to such a request.

Applicants are encouraged to explore innovative training approaches

d the development of new types of health personnel to meet the man-

an
@.. needs of the region as identified in the planning process.
-42-
¢

b. Research - Research into better means of accomplishing the
purposes and objectives of the Regional Medical Program is supportable
under an operational grant. Since other Public Health Service grant
mechanisms provide excellent means for the support of biomedical research,
the grantee under a Regional Medical Program is required to look to
these and other sources of support as well. The support of research
activities through other Public Health Service research support mechanisms
does not lessen the importance of planning and implementing a Regional
Medical Program in a manner which insures a close and continuous linkage
between all of the activities of the regional program and the environment
of research and teaching. |

However, if special justification exists for the support of research
which is essential to the effective accomplishment of the objectives of ¢
the Regional Medical Program, and if it can be demonstrated that the
other sources of support are not appropriate, a limited amount of research
activity could be supported under the Regional Medical Program grant.

c. Demonstrations of Patient Care - Demonstrations of patient care
may be supported when related to the research, training, and continuing
education activities of the program. The Act provides that the costs of
patient care may be supported only when such care is incident to research,
training, or demonstration activities encompassed by the purposes of the
program and only if the patient has been referred by a practicing physician.
Grant funds could be used to pay the other costs incident to the demonstration

activity, including staff and equipment.

d. Support of Administrative Core - The grant may be used to pay ~
the costs for the central administration of the total Regional Medical e

 
- 43 -

 

Program. This could include the salaries of a program coordinator and
other administrative staff as well as the other costs incident to the
central coordination of the Regional Medical Program.

e. Alteration and Renovation - Ninety percent of the costs of
alteration and renovation may be charged to operational grants. No such
charges are permitted to planning grants.

f. Communication Systems - A grant may support the purchase or
rental of communication systems to be used for educational, diagnostic
or other purposes. However, if such requests represent major funding
investments, they should include (as mentioned under Continuing Education
and Training above) documentation of: the measurements of effectiveness

__ of the program; the numbers of people affected by the system; the degree
Wio which the information produced might be generalized to other Regional
Medical Programs; and knowledge of related efforts already accomplished
by others with indications of the manner by which the proposed project

will extend those efforts.

g. Communications and Public Information - A communication and public
information component as an integral part of the proposed regional medical
program might include:

Utilization of a qualified communication and public information
specialist, and necessary supporting staff, in both planning and
operational activities.

Development of studies to evaluate professional and public
attitudes toward the programs.

@ Development and maintenance of a flow of professional and

general information to all special and general interest groups

 
- 44 -

‘

and publics, among other existing regional medical programs, and

between them and the Division of Regional Medical Programs.
Preparation and distribution of printed, visual and

other information material for professional and lay publics.
Participation of this component in planning and conducting

programs, seminars, conferences and other means of exchanging

professional general information.

Plans that do not specifically further understanding, participation and
support as previously defined, or which would appear to provide only for
publicity for the program and aggrandisement of its officials, should not
be included.

Questions related to these aspects of a proposed program may be
directed to the Division of Regional Medical Programs for answers or special
consultation. :

h. Computers ~ Grant funds may be used to purchase computer time,
or if the needs of the program are sufficient, the rental of a computer.
As with all other activities, the costs of acquiring computer capability
must be measured against the benefits to be derived for the program.

i. Diagnostic and Treatment Equipment - Funds may be used to
purchase diagnostic and treatment equipment which is identified, through
the planning process, as being a specific need of the region in carrying
out the purposes of the program. The location of such equipment should be
planned with its efficient and effective use in mind.

j. Support of Staff in Cooperating Institutions - The grant can be

used to pay the salary of staff involved in the conduct of the Regional C
- 44A -

@
Ww

Medical Program, not only in the grantee institution but also in the
other institutions cooperating in the program. The level of salary
support must be consistent with the salary policies cf the institution
concerned. The staff might be engaged in supervising and coordinating
the activities of the Regional Medical Program in the institution or be
involved in specific program elements, such as those discussed above,
ky ‘Consultant Services - The grant could pay for consultant
services related to any program element of the Regional Medical Program
and justified as the most effective means of accomplishing a particular
purpose to be served.
l. Transportation of Patients - When justified as the most efficient
means of carrying out the purpose of the program, grant funds may be used to
@.. the costs of transportation of patients referred for diagnosis and

treatment in other institutions as part of a research, training or demon-

 

stration program. The use of grant funds to pay transportation costs should
be carefully weighed against the use of funds for other activities within
the Regional Medical Program.
D. Relationship to Other Sources of Support

It is expected that no institutional funds formerly devoted to
these activities will be displaced by the use of the Regional Medical
Program grant. Not only should the grantee avoid substituting these
grant funds for other sources of Support, but he should also continue to

seek additional resources for carrying out the objectives of the Regional

Medical Program.
- 44B -

E. Single Grant Approach
Planning as well as operational grants will each be single
instruments of support for activities under the Regional Medical Programs.

The single grant approach is intended to insure an appropriate degree of

cohesiveness in the cooperative approach,

 
~- 45 -

PREPARATION AND REVIEW OF APPLICATION

Eligible Applicants

Method of Obtaining Application

Method of Preparing Application

Review of Application

Notification of Applicant

1.

. Financial Management

General Requirements

The Amount Awarded

Direct Costs

a. Personnel

b. Consultant Costs

c. Hospitalization Costs

d, Travel

e. Rent

f. Communication

g. Printing and Reproductions
h. Equipment

4. Alteration and Renovation ("Construction")
j. Costs not Permitted
Indirect Costs

Rebudgeting of Funds

Refunds

a. Interest or Other Income

b. Royalties and Profits

Page
49

49
49
50
50
51
51
51
51
51
52
52
52
52
53
53
53
53
54
54
59
59
59

60
F,

G.

- 46 -

Financial Management (Continued)
7. Unexpended Balance
8. Obligations or Expenditures
9. Accounting, Records and Audit
a. Accounting
b. Records
c. Audit
10. Equipment (Title and Accountability)
Additional Funds
1. For Continued Support
2. Supplemental Funds
3. Support Beyond the Program Period
Program Evaluation
Changes in Approved Program
Change of the Grantee
Change of Program Coordinator
Change in the Program Period
Early Termination of the Grant
1. By the Grantee
2. By the Public Health Service
Reports |
1. Progress
2. Regional Advisory Group
3. Expenditures

4. Time or Effort

5. Invention

Page
60

60
61
61
62
63
63
64
64
64
64
65
65
66
66
67
67
67
67
67
67
68
68
69

69

 
e
2
a.

0.

Miscellaneous
1. Safety Precautions
2. Federal Income Tax

3. Military Service

- 47 -

Page
69

69

69

 
V. PREPARATION AND REVIEW OF APPLICATIONS’

A. Eligible Applicants

The following are eligible applicants for both planning and

operational grants: public, or private non-profit universities, medical
schools, research institutions, and other public, or non-profit private
agencies and institutions located in any state, the District of Columbia,
Puerto Rico, or the Virgin Islands. The applicant must be authorized to
represent the participating institutions who propose to be involved in
the planning and operation of the Regional Medical Program. The applicant
must be able to exercise program coordination and fiscal responsibility in

assuring the effective use of the grant funds. The applicant is legally

O .cocsinie for expenditure of funds both by itself and cooperating

institutions.
B. Method of Obtaining Application
Application form NIH-925, which is used both for planning and
operational grants, whether they are new, continuation, or supplemental,
may be obtained by writing the Division of Regional Medical Programs,
National Institutes of Health, Bethesda, Maryland, 20014.
C. Method of Preparing Application
Applications should be prepared in accordance with information

contained in these guidelines and with the specific instructions included

with the application.

6

 
Applications will be reviewed by the staff, by consultants to

D. Review of Application

the Division of Regional Medical Programs, and as required by statute,

by the National Advisory Council on Regional Medical Programs. Under

terms of the law, a grant may not be awarded unless it has been recommended
for approval by the National Advisory Council.

The rigorous review process requires that sufficient information
be provided in the application to enable the reviewers to reach considered
and informed judgments concerning the nature, feasibility and soundness of
the proposal and to weigh the use of grant funds for the particular
proposal against benefits to be gained from the use of grant funds
elsewhere.

A complete, informative application will facilitate and expedite 6
the review of an application. When necessary in the judgment of the staff
or consultants, additional information or justification may be required
either by supplemental documents or by conferences and visits.

E. Notification of Applicant
Copies of a Notice of Grant Awarded are sent to the grantee, This

notice indicates the program period, the amount being awarded (including

the budget period covered), and any special conditions under which the

grant is awarded.

¢

 
- 51 -

®@ F. Financial Management

1. General Requirements - Funds granted may be used only for

 

services, materials and other items required to carry out the approved
program. Circular A-21 of the Bureau of the Budget should be used to
the extent practicable in determining allowable costs related to the
grants for Regional Medical Programs. Where the Division of Regional
Medical Programs requires prior approval for items not listed in the
approved budget, a written request must be made by the grantee to the
Division of Regional Medical Programs in advance of the performance of
the act which requires the obligating or expenditure of funds.

2. The Amount Awarded - There is no fixed limitation on the
amount of funds that may be awarded, The-budget must have a direct

ee“ to the activities proposed. The size of the various program
~ é@lements included in the budget should be carefully considered in terms

of the relative effectiveness in accomplishing the purposes of the Regional
Medical Program. The budget should also have a direct relationship to the
reasonable expectations for the rate of implementation of the proposed
programs,

3. Direct Costs - The tollowing are examples of direct costs
that may be charged to a Regional Medical Program grant:

a. Personnel - Salaries, wages, and fringe benefits of

personnel in proportion to the time or effort expended on the program
and in accordance with institutional policy, may be charged to this
category. Adequate time and effort records must be maintained in order

to substantiate these costs.

 
- 52 -
~
b. Consultant Costs - Grant funds may be used to pay ¢

consultant fees for services related to any program element of the
Regional Medical Program providing that these services are the most
effective means of accomplishing a particular purpose, and that the
consultant is not on the staff of the grantee or cooperating institution.
If consultation is obtained from a staff member of the grantee or
cooperating institution, a proportionate amount of his regular salary
may be paid by the grant. In either case, consultant costs must be
supported by a clear statement of services performed and if appropriate,
the number of man days of service.

c. Hospitalization Costs - The method of determining
hospitalization costs is still under consideration by the Division of
Regional Medical Programs. It will be distributed at a later date.

d. Travel - Per diem reimbursements to travelers, personal é
transportation charges, and reimbursements for authorized use of
personally owned automobiles are chargeable under this category.

Less than first class travel accommodations shall be used
except in extenuating circumstances. Automobile mileage and any foreign
travel must be in accordance with institution policy. Any foreign travel
must receive prior approval from the Division of Regional Medical Programs.

e. Rent - The expenses for rental of facilities not owned
by the grantee or participating institution may be charged in proportion
to the space actually utilized for the program, Rental costs may not

be in excess of comparable rentals in the particular locality, and must

be in accordance with institution policy.

 
- 53 -

© f£. Communication - That portion of communication charges

necessary to the planning or implementation of the program or project
may be charged to this category. In no case may institutional local
and regular monthly telephone costs and normal postage charges not
related to the Regional Medical Progranis be charged to the grant.

ge Printing and Reproduction - Printing of pamphlets,
brochures, and other materials necessary for this program may be charged
to this category.

h. Equipment - Rental and purchase of equipment for the
planning or implementation of a program may be charged to this category.
When acquiring equipment, consideration of the relative advantages of

lease versus purchase should be considered.

 

@ i. Alteration and Renovation ("Construction") - Under the
“Act "construction" means alteration, restoration to a sound state,
remodeling and renovation of existing buildings (including initial
equipment thereof), and replacement of obsolete built-in equipment of
existing buildings. Built-in equipment is equipment affixed to the
facility and customarily included in a building contract. The applicant
is required to furnish in sufficient detail plans and specifications, as
well as a narrative description, to indicate the need, nature and purpose
of the proposed "construction."

Operational grant funds may not support more than 90% of the

cost of such "construction" or equipment.

¢
New facilities may not be constructed under this program.

- 54 -

¢

Where construction of new facilities is considered necessary for

furthering the program, the applicant may seek construction funds

under other applicable Federal programs, such as the Hill-Burton,

Health Research Facilities, and the Health Professions Educational

Assistance programs.

j. Direct Costs not Permitted - The following direct costs

or charges are not allowable:

(1)
(2)

(3)
(4)
(5)

Honoraria as distinguished from consultant fees
Entertainment (cost of amusement, social activities,
entertainment and incidental costs thereto, such as
meals, lodging, rentals, transportation and gratuities).
Payment to Federal employees q
Petty cash funds .
Subgranting (a subgrant is any allocation of grant

funds by the grantee to other individuals or

organizations for purposes over which the grantee

 

institution named on the application does not maintain
scientific and financial responsibility. A grantee

may contract for services, but may not subgrant.)

‘4, Indirect Costs - Institutional indirect cost rates will be

based on the percentage relationship that total institutional indirect

cost is to the total direct salaries and wages paid by the institution

(not just the research indirect cost pool).
- 55 -

D Data taken directly from the grantee or cooperating
institutions most recent annual financial report and immediately
available supporting information will be utilized as a basis for
determining the indirect cost rate applicable to a Regional Medical
Program grant at the institution.

Total expenditures as taken from the most recent annual
financial report will be adjusted by eliminating from further consideration
the following items or categories of expenditure:

a. The costs of equipment, buildings, and repairs which
materially increase the value or useful life of buildings or equipment.

However, depreciation and use charges may be included in
determining total expenditure. .

b. Advertising other than for recruitment of personnel,
procurement of scarce items or the disposal of scrap or surplus material.

c. Bad debts

d. Contingency reserves

e. Commencement. and convocation costs

f. Entertainment costs

g. Fines and penalties

h. Interest, fund raising and investment management costs

i. Losses on other agreements or contracts

j. Profits and losses on disposition of plant, equipment,

or other capital costs.

 
- 56 -

¢

m. Special services costs incurred for general public relations

k. Public information services costs

1. Scholarships and student aid costs

n. Student activity costs

o. Student dormitory costs

p. Student services costs

q- Costs used in arriving at a hospitalization rate or
interdepartmental charge

r. Unrelated hospital costs

s. Other inappropriate costs

Where any types of expense ordinarily treated as general administration
and general expenses or departmental administration expenses are charged to
a Division of Regional Medical Programs grant as direct costs, the similar @
type of expenses applicable to other activities of the institution must, ~
through separate cost groupings, be excluded from the indirect costs
allowable to a Division of Regional Medical Programs grant.

The indirect cost rate will then be computed by dividing the total
direct salaries and wages paid by the institution into the total adjusted
indirect cost incurred by the institution.

When, under an operational grant, the cooperating institutions
are preparing their budgets for submission to the grantee, the
institutions’ indirect cost rates, based on salaries and wages, should

be stated in the budget. To substantiate this rate, the cooperating
-57 -

Dcvcccson should supply the grantee with adequate substantiating
data, such as documents certifying that the overall institutional
indirect cost rate has been audited and approved by the PHS, another
Government agency, or an independent accounting firm. In addition,
the total institutional indirect cost, and direct salaries and wages
should be stated as separate amounts. The institution should indicate
whether fringe benefits are included in the salary and wage base or not.
A detailed indirect cost proposal should accompany each new or continuing
grant application. When an applicant is submitting a planning grant 5
application to the Division of Regional Medical Programs, the above
procedures also apply.

Indirect costs are those which, because of their incurrence usually
@« common or joint objectives, are not readily identified with individual
projects, All costs representing charges associated with the activities
of the grantee or cooperating institutions which are supportive of the
conduct of the Regional Medical Program, except those which are specifically
approved by the Division of Regional Medical Programs as direct costs, are.

classified as indirect costs. The general types of indirect costs are:
a. General administration and expenses which are incurred
for the executive and administrative offices of an institution
receiving grants, and other expenses of a general character
which do not relate solely to any specific unit in the

institution, or to any specific project in the institution;

 
~ 58 -

 

b. Program administration expenses which apply to

program activities administered in whole or in part by

a separate organization or an identifiable administrative

unit. Examples of work relating to grant programs which

is sometimes performed under such organizational arrangement

are: grant administration, purchasing, personnel, accounting,
etc.;

c. Operation and maintenance expenses incurred for operating
and maintaining an institution's physical plant, including
expenses normally incurred for administration or supervision

of the physical plant; janitorial service} utilities, including
telephone installation and maintenance costs; and other expenses
customarily associated with the operation, maintenance, preserva- @
tion, and protection of thé institution's physical facilities;

d. Reimbursements and other receipts from the Federal

Government which are used by the institution to support directly,
in whole or in part, any of the administrative or service (indirect)
activities received pursuant to an institution's base grant or
any similar contractual arrangement with the Federal Government
shall be treated as a credit to the total indirect cost pool.
Such set-off shall be made prior to the determination of the
indirect cost rate submitted to the Division of Regional Medical

Programs. These credits include indirect cost reimbursements

 
@

- 59 -

contained in payments for hospitalization, interdepartmental

charges and centralized facilities operated by the institution.

5. Rebudgeting of Funds - The grantee or cooperat ing

institutions may depart from the approved budget and use the funds for

other items required for the project, except for the following restrictions:

a.

Grant funds may not be used for any purpose

contrary to the regulations and policies of

the Division of Regional Medical Programs or

the grantee or the cooperating institutions.
Grant funds may be transferred between budget
categories to the extent that no category is
increased or decreased by more than 20% of the
approved budget. Increases or decreases in a
budget category in excess of 20% must be approved

by the Division of Regional Medical Programs.

6. Refunds - During the program period, refunds and rebates

should be credited to the account. Credits received after the termination

of the program period shall be returned to the Public Health Service.

Checks should be made payable to National Institutes of Health, PHS,

DHEW, Bethesda, Maryland, 20014.

a.

Interest and other income - Interest or other income

earned on grant funds must be returned to the Public

Health Service.

 
-~ 60 -
b. Royalties and Profits - When the costs of publishing q
material are provided from Public Health Service grants,
any royalties or profits up to the amount charged to the
grant for publishing the material shall be refunded to
the Public Health Service.

7. Unexpended Balance - Continued use of any unobligated or
unexpended funds remaining in the grant account at the. end of the budget
period should be justified by the grantee when the Expenditures Report
is submitted to the Division of Regional Medical Programs. If adequate
justification is received, the Division of Regional Medical Programs
will advise the grantee that such funds may be used during the subsequent
budget period. If inadequate justification, or no justification is pre-
sented, unexpended funds will be used toward payment of the total amount
requested for the subsequent budget period. The unexpended balance as
shown in the final Expenditures Report must be returned to the National

Institutes of Health, PHS, DHEW, Bethesda, Maryland, 20014.

 

8. Obligations or Expenditures - Obligations, commitments,
encumbrances, or expenditures will normally be made within the period
indicated on the notice of grant award. Grant funds may not be used to
reimburse any such obligations, commitments or expenditures made prior
to the beginning date of the initial grant for a new or renewal project.

In exceptional instances the grantee may, at its own risk, prior to the

 
- 61 -

t
> vvcrine date of a continuation award, incur expenditures which exceed

existing Division of Regional Medical Programs authorization but which

are considered essential to the conduct of the project. The Division

of Regional Medical Programs may allow reimbursement of such expenditures

from the continuation grant.

9.

Accounting Records and Audit -_
a. Accounting - Accounting for grant funds will be in
accordance with the grantee and/or cooperating institution
accounting practices consistently applied regardless of the
source of funds. Itemization of all supporting expenditures
must be recorded in sufficient detail to show the exact nature
of expenditures. Each recipient of grant funds shall keep such
records as the Surgeon General may prescribe, including records
which fully disclose the amount and disposition by such reci-
pient of the proceeds of such grant, the total cost of the
program or undertaking in connection with which such grant is
made or used, and the amount of that portion of the cost of the
program or undertaking supplied by other sources, and to make
such records available as will facilitate an effective audit
by authorized personnel. Such a system must meet the following
criteria:

(1) A special grant account must be established for

each Regional Medical Program grant and be maintained

at the grantee institution designated on the application.
Responsibility for expenditure of funds by
participating institutions must be assumed by
the named grantee institution.

(2) The accounting records at the grantee institution
shall provide the information needed to identify
the receipt and expenditure of all program funds
separately for each grant. Expenditures shall be
recorded by the component program and budget cost
categories shown in the approved budget.

(3) Each entry in the accounting records at the
grantee or cooperating institution shall refer
to the documentation which supports the entry
and the documentation shall be filed in such a @
way that it can be readily located.

(4) The accounting records shall provide accurate
and current financial reporting information.

(5) The accounting system shall possess an adequate
means of internal control to safeguard the assets,
check the accuracy and reliability of the accounting
data, promote operational efficiency, and encourage
adherence to prescribed management policies.

b. Records - The financial records, including all documents
to support entries on the accounting records, must be kept

readily available for examination by authorized personnel.

¢
- 63 -

No such records shall be destroyed or otherwise disposed

of within three years after the termination of the program.

Unless written approval is obtained from the Public Health

Service to dispose of the records, they must be retained
_until the audit has been completed and all questions about

the expenditures are resolved.

ce. Audit - The Division of Regional Medical Programs follows

generally accepted auditing practices in determining that

there is a proper accounting in use of grant funds. Failure

of a grantee to appeal a proposed audit disallowance within

thirty days after receipt of a written notification will make

 

the action of the Division of Regional Medical Programs

@ conclusive.

10. Equipment (Title and Accountability)

 

Title to equipment purchased with grant funds resides in the grantee
institution and accountability may be waived at the termination of the
grant by the Division of Regional Medical Programs as long as the equipment
is used to further the objectives of the Public Health Service. The
Division of Regional Medical Programs, however, reserves the right under
unusual circumstances to transfer title of equipment to the Division of
Regional Medical Programs or to another grantee.

Excess materials and supplies retained by the grantee upon

termination of the program may be accounted for under the same terms

as equipment.
- 64 -

To obtain additional funds for support of a program, the procedures

G. Additional Funds

vary according to the need as follows:

1. For continued support ~- An application form requesting
support for the next budget period of the program period (continuation
grant) will be mailed to the grantee institution about 4 months before
the beginning date of the next budget period. It is the responsibility
of the grantee to request this application form if it is not received.

The application should be submitted in accordance with the instructions
accompanying the form.

2. For supplemental funds - If additional funds to conduct
the program are required within any portion of the program period over
those budgeted and approved, and such funds are not available within @
the institution receiving support for the program, a supplemental
application may be submitted. A face sheet, budget page, and justifica-
tion are required for a supplemental award. A supplemental grant forms
a part of the initial award and only one report of expenditures is required.

Supplemental applications are processed in the same
manner as new applications and must compete for available funds, except
those applications to meet increased administrative costs, such as
fringe benefits or salary increases, may be administratively approved.

3. Support beyond the Program Period - If additional support
beyond the program period is required, a new application must be submitted,
This application will go through the normal review process and will
compete with other applications for available funds. If approved, an

@

initial grant for a new program period will be awarded.

 
- 65 -

i H

all aspects of the planning and operational activities appropriate

. Program Evaluation

The grantee should make a special effort to incorporate into

mechanisms for evaluating the effectiveness of all aspects of the Regional
Medical Program. The concern with the evaluation should begin in the
planning process so that the planning process may include planning for
evaluation mechanisms. The exploratory nature of the Regional Medical
Programs makes the need for the realistic evaluation mechanisms especially
important. Particular attention to the evaluation process will provide
the means for the grantee to assess his progress and accomplishments and
will also provide the basis for the preparation of progress reports which
can be used by the Division of Regional Medical Programs in evaluating the
Qo isimenes of the total national program.

I. Changes in Approved Program

The Division of Regional Medical Programs does not intend to
interfere with administrative or program flexibility which serves the
objectives of the Regional Medical Programs. If, however, a change is
determined by the grantee to be desirable, and if that change would
constitute a substantial change in the nature of the program originally

approved, the grantee should consult with the Division of Regional

Medical Programs staff.

 
- 66 -

J. Change of Grantee

If the grantee expects to relinquish active direction of the
program, the Division of Regional Medical Programs must be notified
immediately. The grantee may request that the grant be terminated, in
which case a terminal progress report, an expenditures report, and
invention statement (PHS-3945) mist be submitted. The grantee may
request that the program be continued under the direction of another
institution.

If the grantee terminates its responsibility for the program,
the new institution may submit a new grant application for the remainder
of the program period. The application should include the reasons for
transferring the program and the probable effect of the move on the
program. Administrative approval may be given by the Division of Regional @
Medical Programs to continue the program at the new institution.
Applications, however, that reflect major changes will be referred to
the National Advisory Council on Regional Medical Programs for recom-
mendation.

K. Change of Program Coordinator

The program coordinator named in the application shall be
responsible for coordination of the program during the period for which
- the grant was awarded,

A change of program coordinator or other key official directing the
program requires approval by the Division of Regional Medical Programs. The

grantee is required to notify the Division of Regional Medical Programs

if such a change is necessary. ®

 
- 67 -

beyond June 30, 1969) without additional funds, if requested by the

L. Change in Program Period

The program period may be extended up to 12 months (but not

grantee before the end of the program period.
M. Early Termination of Grant

1. By the Grantee - A grant may be terminated or cancelled
at any time by the grantee upon written notification to the Division
of Regional Medical Programs stating the reacons for termination.

2. By the Public Health Service - A grant may be revoked or
terminated by the Surgeon General, in whole or in part, in any time
within the program period whenever it is determined that the grantee
has failed in a material respect to comply with the terms and conditions

@ the grant, The grantee will be promptly advised of the reasons for

termination of the grant in writing.

N. Reports
All reports required to be submitted to the Public Health

Service should be sent to the Division of Regional Medical Programs,
Public Health Service, Bethesda, Maryland, 20014.

1. Progress Reports - The grantee is required to submit an
annual progress report. This report should contain sufficient detail
to inform the reader of the accomplishments with particular respect

to the objectives originally set forth. These progress reports must

 
- 68 -
be submitted with the application for a continued support. In addition, ©
grantees may be required to supply other information needed for guidance
and development of the national program and are encouraged to report
significant developments promptly at any time. A terminal progress
report must be submitted to the Division of Regional Medical Programs
within three months of the termination of the program period.

-2. Regional Advisory Group - The Regional Advisory Group is

expected to prepare an annual statement on the effectiveness of the
regional cooperative arrangements established under the Regional Medical
Program. The report should be submitted to the Division of Regional
Medical Programs by the grantee along with the annual progress report.
Periodic reviews of grants by the staff of the Division and the Advisory
Council will include consideration of the effectiveness of the Advisory  )
Group in serving its essential purpose. ,

3. Expenditures Report (Form NIH-925-3) - A single expenditures
report and a single narrative progress report is required to be submitted
by the named grantee on behalf of all cooperating institutions to the
Division of Regional Medical Programs for each budget period of the program
period. If the grantee fails to submit an expenditures report within 120
days after the end of each budget period, future awards for that project
may be withheld.

A supplemental grant forms a part of the existing grant and only

one expenditure report need be submitted on the combined grants.

 
- 69 -

4, Time or Effort Report - Charges for salaries and wages of

 

individuals other than members of the professional staff will be supported
by time and attendance and payroll distribution records. For members of
the professional staff, quarterly estimates of the percentage distri-
bution of their total effort must be used as support in the absence of
actual time records. Time and effort reports are not to be sent to the
Division of Regional Medical Programs but must be retained by the grantee
and must be made available for inspection by the Public Health Service
staff.

5. Invention Report - Immediate and full reporting of all
inventions to the Public Health Service is required.

O. Miscellaneous

6 1, Safety Precautions - The Public Health Service assumes no

responsibility with respect to accident, claims or illness arising out
of any work undertaken with the assistance of a Public Health Service
grant, The grantee institution is expected to take necessary steps to
insure or protect itself and its personnel,

2. Federal Income Tax - Determination of a tax status of an
individual receiving compensation in any form from the Public Health
Service grant is the responsibility of the Internal Revenue Service.

3. Military Service - The Public Health Service will not

intercede on behalf of an individual in relation to military status.

 
-71-

- Public Law 89-239
89th Congress, S. 596
October 6, 1965

An Act

To amend the Public Health Service Act to assist in combating heart disease,
cancer, stroke, and related diseases.

 

Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled, That this Act may
be cited as the “Heart Disease, Cancer, and Stroke Amendments of
1965”.

Sec. 2. The Public Health Service Act (2 US.C., ch. 6A) is
amended by adding at the end thereof the following new title:

“TITLE IX—EDUCATION, RESEARCH, TRAINING, AND
DEMONSTRATIONS IN THE FIELDS OF HEART DIS-
EASE, CANCER, STROKE, AND RELATED DISEASES

“PURPOSES

“Sec. 900. The purposes of this title are—

“(a) Through grants, to encourage and assist in the establishment
of regional cooperative arrangements among medical schools, research
institutions, and hospitals for research and training (including con-
tinuing education) and for related demonstrations of patient care in
the fields of heart disease, cancer, stroke, and related diseases;

“(b) To afford to the medical profession and the medical institu-
tions of the Nation, through such cooperative arrangements, the oppor-
tunity of making available to their patients the latest advances in the
diagnosis and treatment of these diseases; and

“(c) By these means, to improve generally the health manpower
and facilities available to the Nation, and to accomplish these ends
without interfering with the patterns, or the methods of financing, of
patient care or professional practice, or with the administration of

ospitals, and in cooperation with practicing physicians, medical cen-
ter officials, hospital administrators, and representatives from appro-
priate voluntary health agencies.

“AUTHORIZATION OF APPROPRIATIONS

“Sec. 901. (a) There are authorized to be appropriated $50,000,000
for the fiscal year ending June 30, 1966, $90,000,000 for the fiscal year
ending June 30, 1967, and $200,000,000 for the fiscal year ending June
30, 1968, for grants to assist public or nonprofit private universities,
medical schools, research institutions, and other public or nonprofit
private institutions and agencies in planning, in conducting feasibility
studies, and in operating pilot projects for the establishment, of re-
gional medical prograins of research, training, and demonstration
activities for carrying out the purposes of this title. Sums appro-
priated under this section for any fiscal year shal] remain available
for making such grants until the end of the fiscal year following the
fiscal year for which the appropriation is made.

“(b) A grant under this title shall be for part or all of the cost of
the planning or other activities with respect to which the application
is made, except that any such grant with respect to construction of,
or provision of built-in (as determined in accordance with regula-
tions) equipment for, any facility may not exceed 90 per centum of
the cost of such construction or equipment. |

“(c) Funds appropriated pursuant to this title shall not be avail-
able to pay the cost of hospital, medical, or other care of patients

EXHIBIT

79 STAT, 926

Heart Disease,
Cancer, and
Stroke Amend=
ments of 1965.
58 Stat, 682.

42 USC 201 note.

 
79 STAT. 927

-~72-

Pub. Law 89-239 October 6, 1965

except to the extent it is, as determined in accordance with regula-
tions, incident to those research, training, or demonstration activities
which are encompassed by the purposes of this title. No patient shall
be furnished hospital, medical, or other care at any facility incident
to research, training, or demonstration activities carried out with
funds appropriated pursuant to this title, unless he has been referred
to such facility by a practicing physician.

“DEFINITIONS

“Sec. 902. For the purposes of this title—

“(a) The term ‘regional medical program’ means a cooperative
arrangement among a group of public or nonprofit private institu-
tions or agencies engaged in research, training, diagnosis, and treat-
ment relating to heart disease, cancer, or stroke, and, at the option
of the applicant, related disease or diseases; but only if such group—

“(1) is situated within a geographic area, composed of any
part or parts of any one or more States, which the Surgeon Gen-
eral determines, in accordance with regulations, to be appropri-
ate for carrying out the purposes of this title;

“(2) consists of one or more medical centers, one or more clin-
ical research centers, and one or more hospitals; and

“(3) has in effect cooperative arrangements among its com-
ponent units which the Surgeon General finds will be adequate
for effectively carrying out the purposes of this title.

“(b) The term ‘medical center’ means a medical school or other
medical institution involved in postgraduate medical training and
one or more hospitals affiliated therewith for teaching, research, and
demonstration purposes.

“(c) The term ‘clinical research center’ means an institution (or
part of an institution) the primary function of which is research,
training of specialists, and demonstrations and which, in connection
therewith, provides specialized, high-quality diagnostic and treat-
ment services for inpatients and outpatients.

“(d) The term ‘hospital’ means a hospital as defined in section
625(c) or other health facility in which local capability for diagnosis
and treatment is supported and augmented by the program established
under this title.

“(e) The term ‘nonprofit’ as applied to any institution or agency
means an institution or agency which is owned and operated by one
ot more nonprofit corporations or associations no part of the net earn- ~
ings of which inures, or may lawfully inure, to the benefit of any
private shareholder or individual. .

“(f) The term ‘construction’ includes alteration, major repair (to
the extent permitted by regulations), remodeling and renovation of
existing buildings (including initial equipment thereof), and replace-
jnent of obsolete, built-in (as determined in accordance with regula-
tions) equipment of existing buildings.

“GRANTS FOR PLANNING

“Sec, 903. (a2) The Surgeon General, upon the recommendation of
the National Advisory Council on Regional Medical Programs estab-
lished by section 905 (hereafter in this title referred to as the
‘Council’), is authorized to make grants to public or nonprofit private
universities, medical schools, research institutions, and other public or
nonprofit private agencies and institutions to assist them in planning
the development of region] medical programs.
- 73-

October 6, 1965 Pub. Law 89-239

“(b) Grants under this section may be niade only upon application
therefor approved by the Surgeon General. Any such application
may be approved only if it contains or is supported by—

“(1) reasonable assurances that Federal funds paid pursuant
to any such grant will be used only for the purposes for which
paid and in accordance with the applicable provisions of this
title and the regulations thereunder;

“(2) reasonable assurances that the applicant will provide for
such fiscal control and fund accounting procedures as are required
by the Surgeon General to assure proper disbursement of and
accounting for such Federal funds;

“(3) reasonable assurances that the applicant will make such
reports, in such form and containing such information as the
Surgeon General may from time to time reasonably require, and
will keep such records and afford such access thereto as the Sur-
geon General may find necessary to assure the correctness and
verification of such reports; and

“(4) a satisfactory showing that the applicant has designated
an advisory group, to advise the applicant (and the institutions
and agencies participating in the resulting regional medical
program) in formulating and carrying out the plan for the estab-
lishment and operation of such regional medical program, which
advisory group includes practicing physicians, medical center
officials, hospital administrators, representatives from appropri-
ate medical societies, voluntary heaJth agencies, and representa-
tives of other organizations, institutions, and agencies concerned
with activities of the kind to be carried on under the program
and members of the public familiar with the need for the services
provided under the program.

“GRANTS FOR ESTABLISHMENT AND OPERATION OF REGIONAL MEDICAL
PROGRAMS

“Sec. 904. (a2) The Surgeon General, upon the recommendation
of the Council, is authorized to make grants to public or nonprofit
private universities, medical schools, research institutions, and other
public or nonprofit private agencies and institutions to assist in
establishment and operation of regional medical programs, including
construction and equipment of facilities in connection therewith.

“(b) Grants under this section may be made only upon application
therefor approved by the Surgeon General. Any such application
may be approved only if it is recommended by the advisory group
described in section 903(b) (4) and contains or is supported by reason-
able assurances that—

“(1) Federal funds paid pursuant to any such grant (A) will
be used only for the purposes for which paid and in accordance
with the applicable provisions of this title and the regulations
thereunder, and (B) will not supplant funds that are otherwise
available for establishment or operation of the regional medical
program with respect to which the grant is made;

(2) the applicant will provide for such fiscal control and fund
accounting procedures as are required by the Surgeon General to
—_ proper disbursement of and accounting for such Federal

unds;

“(3) the applicant will make such reports, in such form and
containing such information as the Surgeon General may from
time to time reasonably require, and will keep such records and

79 STAT, 928

Recordse

 
79 STAT, 929

~ 74 -

Pub, Law 89-239 October 6, 1965

 

49 Stat. 10113
78 Stat. 238,

' 64 Stat. 1267.
63 Stat. 108,

Appointment of
members,

Term of office.

Compensation.

60 Stat. 808;

75 Stat. 339,340.
Applisations for
grants, recom=
mendations.

afford such access thereto as the Surgeon General may find neces-
sary to assure the correctness and verification of such reports; and

“(4) any laborer or mechanic employed by any contractor or
subcontractor in the performance of work on any construction
aided by payments pursuant to any grant under this section will
be paid wages at rates not less than those prevailing on similar
construction in the locality as determined by the Secretary of
Labor in accordance with the Davis-Bacon Act, as amended (40
U.S.C. 276a—276a-5) ; and the Secretary of Labor shall have,
with respect to the labor standards specified in this paragraph,
the authority and functions set forth in Reorganization Plan
Numbered 14 of 1950 (15 F.R. 3176; 5 U.S.C, 1332~15) and sec-
tion 2 of the Act of June 13, 1934, as amended (40 U.S.C. 276c).

“NATIONAL ADVISORY COUNCIL ON REGIONAL MEDICAL PROGRAMS

. “Sec. 905. (a) The Surgeon General, with the approval of the
Secretary, may appoint, without regard to the civil service laws, a
National Advisory Council on Regional Medical Programs. The
Council shall consist of the Surgeon General, who shall be the chair-
man, and twelve members, not otherwise in the regular full-time
employ of the United States, who are leaders in the fields of the
fundamental sciences, the medical sciences, or public affairs. At least.
two of the appointed members shall be practicing physicians, one
shall be outstanding in the study, diagnosis, or treatment of heart
disease, one shall be outstanding in the study, diagnosis, or treatment
of cancer, and one shall be oustanding in the study, diagnosis, or
treatment. of stroke.

“(b) Each appointed member of the Council shall hold office for
a term of four years,-except that any member appointed to fill a
vacancy prior to the expiration of the term for which his predecessor
was appointed shall be appointed for the remainder of such term, and
except that the terms of office of the members first taking office shall
expire, as designated by the Surgeon General at the time of appoint-
ment, four at the end of the first year, four at the end of the second
year, and four at the end of the third year after the date of appoint-
ment. An appointed member shall not be eligible to serve continu-
ously for more than two terms.

eo) Appointed members of the Council, while attending meet-
ings or conferences thereof or otherwise serving on business of the
Council, shall be entitled to receive compensation at rates fixed by
the Secretary, but not exceeding $100 per day, including traveltime,

and while so serving away from their homes or regular places of |

business they may be allowed travel expenses, including per diem in
lieu of subsistence, as authorized by section 5 of the Administrative
Expenses Act of 1946 (5 U.S.C. 73b-2) for persons in the Govern-
ment service employed intermittently.

“(d) The Council shall advise and assist the Surgeon General in the
preparation of regulations for, and as to policy matters arising with
respect to, the administration of this title. The Council shall consider
all applications for grants under this title and shall make recommen-
dations to the Surgeon General with respect to approval of applica-
tions for and the amounts of grants under this title.
-75 -

October 6, 1965 Pub. Law 89-239
49 STAT. 930

“REGULATIONS

“Sec, 906. The Surgeon General, after consultation with the Coun-
cil, shall prescribe general regulations covering the terms and con-
ditions for approving applications for grants under this title and the
coordination of programs assisted under this title with programs for
training, research, and demonstrations relating to the same diseases
assisted or authorized under other titles of this Act or other Acts of
Congress.

SONFORMATION ON SPECIAL TREATMENT AND TRAINING CENTERS

“Src, 907. The Surgeon General shall establish, and maintain on a
current basis, a list or lists of facilities in the United States equipped
and staffed to provide the most advanced methods and techniques
in the diagnosis and treatment of heart disease, cancer, or stroke,
together with such related information, including the availability of
advanced specialty training in such facilities, as he deems useful,
and shall make such list or lists and related information readily avail-
able to licensed practitioners and other persons requiring such infor-
mation. To the end of making such list or lists and other informa-
tion most useful, the Surgeon General shall from time to time consult.
with interested national professional organizations.

“REPORT

“Src. 908. On or before June 30, 1967, the Surgeon General, after Report to
consultation with the Council, shall submit to the Secretary for trans- President and
mission to the President and then to the Congress, a report of the Consress.
activities under this title together with (1),a statement of the relation-
ship between Federal financing and financing from other sources of
the activities undertaken pursuant to this title, (2) an appraisal of
the activities assisted under this title in the light of their effectiveness
in carrying out the purposes of this title, and (3) recommendations
with respect to extension or modification of this title in the light

thereof.
“RECORDS AND AUDIT

“Sec. 909. (a) Each recipient of a grant under this title shall keep
such records as the Surgeon General may prescribe, including records
which fully disclose the amount and disposition by such recipient of
the proceeds of such grant, the total cost of the project. or under-
taking in connection with which such grant is made or used, and
the amount of that portion of the cost of the project or undertaking
supplied by other sources, and such records as will facilitate an effec-
tive audit.
“(b) The Secretary of Health, Education, and Welfare and the
Comptroller General of the United States, or any of their duly author-
ized representatives, shall have access for the purpose of audit and
examination to any books, documents, papers, and records of the
recipient of any grant under this title which are pertinent to any
such grant.”
Sec. 3. (a) Section 1 of the Public Health Service Act is amended 58 Stat. 682.
to read as follows:
“Section 1. Titles I to 1X, inclusive, of this Act may be cited as 42 USC 201-
the ‘Public Health Service Act’.” 298De

 
- ©

Pub. Law 89-239 October 6, 1965
79 STAT, 931

 

(b) The Act of July 1, 1944 (58 Stat. 682), as amended, is further
amended by renumbering title IX (as in effect prior to the enactment
of this Act) as title X, and by renumbering sections 901 through 914
(as in effect prior to the enactment of this Act), and references thereto,
as sections 1001 through 1014, respectively.

Approved October 6, 1965, 10:15 a.m,

42 USC 201
notes

 

LEGISLATIVE HISTORY:

HOUSE REPORT No, 963 accompanying H. R. 3140 (Comm, on Interstate & q@
Foreign Commerce).
SENATE REPORT No, 368 (Comm, on Labor & Public Welfare).
CONGRESSIONAL RECORD, Vol, 111 (1965):
June 25: Considered in Senate.
June 282. Considered and passed Senate,
Sept. 23: H. R. 3140 considered in House.
Sept. 24: Considered and passed House, amended, in lieu of
H. R, 3140,
Sept. 29% Senate concurred in House amendments,

©

%U.S, GOVERNMENT PRINTING OFFICE: 1966 O - 225-892