SEE.
A

APPENDIX 2

Regulations
Regional Medical Programs

 

Subpart E-Grants and Contracts
for Regional Medical Programs .

. (Added 1/18/67, 32 FR 571.)

Authority: The provisions of the Subpart E issued under sec, 215, 58
Stat. 690, sec. 906, 79 Stat. 930; 42 U.S.C. 216, 299f, Interpret or apply
sees. 900, 901, 902, 903, 904, 905, 909, 910, 79 Stat. 926, 927, 928, 929,
930, 42 U.S.C. 299, 299a. 299b. 299c. 299d. 299e. 299i.

54,401 APPLICABILITY.

The provisions of this subpart apply to grants and contracts for
planning, establishment , and operation of regional medical progrars
as authorized by Title IX of the Public Health Service Act, as amended ~
by Public Law 89-239, and amended and extended by PL 90-574 and PL 91-515.

54.402 DEFINITIONS.

(a) All terms not defined herein shall have the meaning given them
in the Act.

(pb) "Act" means the Public Health Service Act, as amended.

(ec) "Title IX" means Title IX of the Public Health Service Act as
amended.

‘(d) "Related diseases" means those diseases which can reasonably
be considered to bear a direct relationship to heart disease, cancer,
stroke, or Kidney Disease.

(e) "Title 1X diseases" means heart disease, cancer, stroke, kidney
disease and related diseases. ,

(f) "Program" means the regional medical program as defined in section
902 (a) of the Act.

(g) "Practicing physici " means any physician licensed to practice
medicine in accordance with applicable State laws and currently engaged
in the diagnosis or treatment of patients. .

(h) "Construction" means new construction of facilities for demonstrations,
research, and training when necessary to carry out regional medical programs.

(i) "Major repair" includes restoration of an existing building to a
sound state.

(j) "Built-in Equipment" is equipment affixed to the facility and
customarily included in the construction contract.

(k) "Advisory group" means the group designated pursuant to section 903(b)
(4) of the Act.
2

(1) "Geographic area" means any area that the Secretary determines
forms an economic and socially related region, taking into consideration
such factors as present and future population trends and patterns of
growth; location and extent of transportation and communication facilities
and systems; presence and distribution of educational, medical and health
facilities and programs, and other activities which in the opinion of
the Secretary are appropriate for carrying out the purposes of Title IX.

54.403 ELIGIBILITY.

In order to be eligible for a grant, the applicant shall:

(a) Meet the requirements of section 903, 904, or 910 of the Act;

(b) Be located in a State;

(c) Be situated within a geographic area appropriate under the
provisions of this subpart for carrying out the purposes of the Act.

54.404 APPLICATION.

(a) Forms. An application for a grant shall be submitted on such forms
and in such manner as the Secrétary may prescribe.

(b) Execution. The application shall be executed by an individual —
authorized to act for the applicant and to assume on behalf of the applicant
all of the obligations specified in the terms and conditions of the grant
including those contained in these regulations.

(c) Description of program. In addition to any other pertinent
information that the Secretary may require, the applicant shall submit
a description of the program in sufficient detail to clearly identify
the nature, need, purpose, plan, and methods of the program, the nature
and functions of the participating institutions, the geographic area
to be served, the cooperative arrangements in effect, or intended to
be made effective, within the group, the justification supported by a
budget or other data, for the amount of the funds requested, and financial
or other data demonstrating that grant funds will not’ supplant funds
otherwise available for establishment or operation of the regional medical
program..

(d) Advisory group; establishment; evidence. An application for a
grant under section 903 of the Act shall contain or be supported by
documentary evidence of the establishment of an advisory group to provide
advice in formulating and carrying out thé’ establishment and operation
of a program.

(e) Advisory group; membership; description. The application or
supporting material shall describe the selection and membership of the
designated advisory group, showing the extent of inclusion in such group
of practicing physicians, members of other health professions, medical
center officials, hospital administrators ; representatives from appropriate
medical societies, voluntary agencies, representatives of other orgariizations,
institutions and agencies concerned with activities of the kind to
be carried on under the program (including as an es officio member, if
there is located in such region one or more hospitals or other health
facilities of the Veterans' Administration, the individual whom the
Administrator of Veterans’ Affairs shall have designated to _serve on
such advisory facilities of such Administration which are located in such
region) and members of the public familiar with the need for and financing
of the services provided under the program.
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(f) Construction; purpose, plans, and specifications; narrative
description. With respect to an application for funds to be used in
whole or part for construction as defined in Title IX, the applicant
shall furnish in sufficient detail plans and specifications as well
as a narrative description, to indicate the need, nature, and purpose
of the proposed construction.

(g) Advisory group; recommendation. An application for a grant
under section 904 of the Act shall contain or be supported by a copy
of the written recommendation of the Advisory group. 7

(h) Advisory groups; recommendation. An application for a grant
umder section 910 of the Act shall contain or be supported by a copy
of a joint recommendation of all advisory groups within the geographic
area of the application.

 

54.405 TERMS, CONDITIONS, AND ASSURANCES.

In addition to any other terms, conditions, and assurances required
by law or imposed by the Secretary, each grant shall be subject to the
following terms, conditions, and assurances to be furnished by the
grantee. The Secretary may at any time approve exceptions where he
finds that such exceptions are not inconsistent with the Act and the
purposes of the program.

(a) Use of funds. The grantee will use grant funds solely for the
purposes for which the grant was made, as set forth in the approved
application and award statement. In the event any part of the amount
paid a grantee is found by the Secretary to have been expended for purposes
or by any methods contrary to the Act, the regulations of this subpart,
or contrary to any condition to the award, then such grantee, upon being
notified of such finding, and in addition to any other requirement, shall
pay an equal amount to the United States. Changes in grant purposes may
be made only in accordance with procedures established by the Secretary. -

(b) Obligation of funds. No funds may be charged against the grant
for services performed or material or equipment delivered, pursuant
to a contract or agreement entered into by the applicant prior to the
effective date of the grant.

(c)- Inventions or discoveries. Any grant award hereunder in whole or
in part for research is subject to the regulations of the Department of
Health, Education, and Welfare as set forth in Parts 6 and 8 of Title 45,
as amended. Such regulations shall apply to any program activity for which
grant funds are in fact used whether within the scope of the program as
approved or otherwise. Appropriate measures shall be taken by the grantee
and by the’ Secretary to assure that no contracts, assignments, or other
arrangements inconsistent with the grant obligation are continued or entered
into and that all personnel involved in the supported activity are aware
of and comply with such obligation. Laboratory notes, related technical
data, and information pertaining to inventions or discoveries made through
activities supported by grant funds shall be maintained for such periods,
and filed with or otherwise made available to the Secretary or those he
may designate at such times and in such manner as he may determine necessary
to carry out such Department regulations.
.

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(d) Reports. The grantee shall maintain and file with the Secretary
such progress, fiscal, and other reports, including reports of meetings
of the advisory group or groups convened before and after award of a
grant under section 904 of the Act, as the Secretary may prescribe.

(e) Records retention. All construction, f financial, and other
records relating to the use of grant funds shall be retained until

. the grantee has received written notice that the records have been

audited unless a different period is permitted or required in writing
by the Secretary.

(f) Responsible official. The official designated in the application
as responsible for the coordination of the program shall continue to
be responsible for the duration of the period for which grant funds
are made available. The grantee shall notify the Secretary immediately
if-such official becomes unavailable to discharge this responsibility.
The Secretary may terminate the grant whenever such official shall
become thus unavailable unless the grantee replaces such official

with another official found by the Secretary to be qualified.

54.406 AWARD.

Upon recommendation of the National Advisory Council on Regional
Medical Programs, and within the limits of available funds, the
Secretary shall award a grant to those applicants whose approved
programs will in his judgment best promote the purposes of Title IX.

In awarding grants, the Secretary shall take into consideration, among
other relevant factors the following: | .

(a) Generally, the extent to which the proposed program will carry
out, through regional cooperation, the purposes of Title IX, within a
geographic area.

(b) The capacity of the institutions or agencies within the program,
individually and collectively, for research, training, and demouetreltten
activities with respect to Title IX.

(c) The extent to which the applicant or the participants in the program
plan to coordinate or have coordinated the regional medical program with
other activities supported pursuant to the authority contained in the
Publie Heaith Service Act and other Acts of Congress including those
relating to planning and use of facilities, persormel, and equipment,
and training of manpower.

(d) The population to be served by ‘the* regional medical program
and relationships to adjacent or other regional medical programs .

_ (e) The extent to which all the health resources of the region
have been taken into consideration in the plaming and/or establishment
of the program.

- (£) The extent to which the participating institutions will utilize
existing resources and will continue to seek additional nonfederal resources
for carrying out the objectives of the regional medical program.

(g) The geographic distribution of grants throughout the Nation.

 

 
54.407 TERMINATION.

(a) Termination by the Secretary. Any grant award may be revoked
or terminated by the Secretary in whole or in part at any time whenever
he finds that in his judgment the grantee has failed ina material
respect to comply with requirements of Title. IX and the regulations
of this subpart. The grantee shall be promptly notified of such:
finding in writing and given the reasons therefor.

(b) Termination by the grantee. A grantee may at any time terminate
or cancel its conduct of an approved project by notifying the Secretary
in writing setting forth the reasons for such termination.

(c) Accounting. Upon any termination, the grantee shall account
for all expenditures and obligations charged to grant funds: Provided,
That to the extent the termination is due in the judgment of the
Secretary to no fault of the grantee, credit shall be allowed for the
amount required to settle at costs demonstrated by evidence satisfactory
to the Secretary to be minimum settlement costs, any noncancellable
obligations incurred prior to receipt of notice of termination.

54,408 NONDISCRIMINATION.

Section 601 of Title VI of the Civil Rights Act of 1964, 42 U.S.C.
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 receiving Federal financial assistance. Regulations
implementing the statute have been issued as Part 80 of the Title Ko,
Code of Federal Regulations. The regional medical programs provide
Federal financial assistance subject to the Civil Rights Act and the
regulations. Each grant is subject to the condition that the grantee
shall comply with the requirements of Executive Order 11246, 30 F.R.
12319, and the applicable rules, regulations, and procedures prescribed
pursuant thereto.

54.409 EXPENDITURES BY GRANTEE.

(a) Allocation of costs. The grantee shall allocate expenditures
as between direct and indirect costs in accordance with generally
accepted and established accounting practices or as otherwise prescribed
by the Secretary.

(b) Direct costs in general... Funds granted for direct. costs. may
be expended by the grantee for personal services, rental of space,
materials, and supplies, and other items of necessary cost as are
required to carry out the purposes of the grant. The Secretary may
issue rules, instructions interpretations, or limitations supplementing
the regulations of this subpart and prescribing the extent to which
particular types of expenditures may be charged to grant funds.

(c) Direct costs; personal services. The costs of personal services
are payable from grant funds substantially in proportion to the time
or effort the individual devotes to carrying out the purposes of the
grant. In such proportion, such costs may include all direct costs
- ineident to such services, such as salary during vacation and retirement
and workmen's compensation charges, in accordance with the policies and

accounting practices consistently applied by the grantee to all its activities.
~6-

(d) Direct costs; care of patients. The cost of hospital, medical .
or other care of patients is payable from grant funds only to the
extent that such care is incident to the research, training, or
demonstration activities supported by a grant hereunder. Such care
shall be incident to such activities only if reasonably associated
with and required for the effective conduct of such activities, and
no such care ‘shall be charged to such funds unless the referral of
the patient is documented with respect to the name of the practicing
physician making the referral, the name of the patient, the date of
referral, and any other relevant information which may be prescribed
by the Secretary. Grant funds shall not be charged with the cost of-

(1) Care for intercurrent conditions (except of an emergency
nature where the intercurrent conditions result from the care for
which the patient was admitted for treatment) that unduly interrupt,
postpone, or terminate the conduct of such activities.

(2) Inpatient care if other care which would equally effectively
further the purposes of the grant could be provided at a smaller
cost.

(3) Bed and board for inpatients in excess of the cost of semiprivate
accommodations unless required for the effective conduct of such
activities. For the purpose of this paragraph, "semiprivate accommodations
means two-bed; three-bed, and four~—bed acconmodations.

t

54.410 PAYMENTS,

The Secretary shall, from time to time, make payments to a grantee
of. all or a portion of any grant award, either in advance or by way
of reimbursement for expenses to be incurred or incurred to the extent
he determines such payments necessary to carry out the purposes of
the grant.

54.411 DIFFERENT USE OR TRANSFER: GOOD CAUSE FOR OTHER USE.

(a) Compliance by grantees. If, at any time, the Secretary determines
that the eligibility requirements for a program are no longer met’, or
that any facility or equipment the construction or procurement of which
was charged to grant funds is, during.its useful life, no longer being
used for the purposes for which it was constructed or procured either
by the grantee or any transferee, the Government shall have the right
to recover its proportionate share of the value of the facility or
equipment from either the grantee or the transferee or any institution
that is using the facility or equipment. The Government's proportionate
share shall be the amount bearing the same ratio to the then value of
the facility or equipment, as determined by the Secretary as the amount
the Federal participation bore to the cost of construction or procurement.

(b) Different use or transfer; notification. The grantee shall
promptly notify the Secretary in writing if at any time during its
useful life the facility or equipment for construction or procurement
of which grant funds were charged is no longer to be used for the purposes
for which it was constructed or procured or is sold or otherwise

transferred. _
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(c) Forgiveness. The Secretary may for good cause release the grantee
or other owner from the requirement of continued eligibility or from
the obligation of continued use of the facility or equipment for the
grant purposes. In determining whether good cause exists, the Secretary
‘shall take into consideration, among other factors, the extent to ,
“which- . :

.

(1) The facility or equipment will be devoted to research, training,
demonstrations, or other activities related to Title IX diseases.

(2) The circumstances calling for a change in the use of the facility
were not known, or with reasonable diligence could not have been known
to the applicant, at the time of the application, and are circumstances
reasonably beyond the control of the applicant or other owner.

(3) There are reasonable assurances that other facilities not
previously utilized for Title IX purposes will be so utilized and
are substantially the equivalent in nature and extent for such purposes.

54,412 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 represent the views
of the Service.

54.413 COPYRIGHTS.

Where the grant-supported activity results in copyrightable material,
the author is free to copyright, but the Health Services and Mental
Health Administration reserves a royalty-free, nonexclusive, irrevocable
license for use of such material. .

 

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54.414 INTEREST.

Interest or other income earned on payments under this subpart shall
be paid to the United States as such interest is received by the grantee.

$
APPENDIX 3

SUGGESTED AFFILIATION AGREEMENT
FOR COOPERATION IN A REGIONAL
MEDICAL PROGRAM

For the purpose of accepting Regional Medical Program funds and
for the further purpose of voluntarily acknowledging the required
fiscal responsibility,
the Regional Medical Program grantee, and
the affiliating institution (or agency), in full recognition of the
necessity for the affiliate to expend Federal monies received by the
grantee under Title IX of the Public Health Act, as amended, and to
assist the grantee in meeting its responsibilities under the terms
of the grant, do enter into this agreement in support of the provisions
of Sections 903(b), 904(b), or 910 of the Act (copy of Title IX should
be attached to this agreement).

Further, as a basis of assuring appropriate fiscal accountability
in the expenditure of Regional Medical Program grant funds, the above
institutions (or agencies) do hereby execute this Agreement of Affiliation.
And the affiliating institution does hereby give its assurances that
it will administer, expend and be accountable for Regional Medical
Program grant funds in accordance with the Act and in accordance with
the current and future regulations and policies as may be outlined in
the Guidelines of the grantor.

Accordingly, the above is mitually agreed by the parties to this
affiliation agreement as witnessed by the signatures of their responsible
officials.

 

 

 

 

Regional Medical Program Grantee Affiliate °

 

 

Responsible Official Responsible Official

 

 

Title Title

Date 19