x

a

EE

a

Rarer

RN TES HII

TLL RATER
“i

nanan un.

\\

QE

in the Act. . As used in this Part:

51b. 103 Eligibility.
i és

FIRST DRAFT REGULATIONS

Grants for Regional Medical Programs

"101 Applicability.
f

4 The provision of this Part are applicable’ to the award of grants
der section 903 and 904 of the Public Health Service Act (42 USC
299 c and d) for planning, establishment and operation of Regional

Medical Programs. » ‘

2 .
Yb. . “ 4 CF Soe CF i ae ar are .
“Sb. 102 Definition. “@* ferns C&&S (ogee «ey
All terms not defined herein shall have the meanings given then

(a) "Acti means Title IX of the Public Health Service Act, as
amended (42 USC 299 et req.).

(b) “’Sécretary" means the Secretary of Health, Education, and
Welfare and any other officer or employee of the Department of
Health, Education, and Welfare to whom the authority involved has
been delegated.
“

(c) "Related Diseases" means those diseases which can reasonably
be considered to bear a direct relationship to heart disease,
cancer, stroke, or kidney disease,

ge wd *%
(d) "Title IX diseases'' means heart disease, cancer, stroke,
kidney disease, and related diseases:

(e) "National Advisory Council'' means the National Advisory Council
on Regional Medical Programs, established by section 905 of the Act.

(£) “Regional Advisory Group" means the advisory group designated
pursuant to section 903(b)(4) of the Act, and meeting the require-
ments of 51b. 109, to advise a particular Regional Medical Program.

¢
To be eligible for a grant under this subpart, the applicant must:

(a) Be a public or nonprofit private university, medical school,
research institution, or other public or non-profit private agency

or institution, or a combination thereof; and scssnty mvitemmpeusmesnns
} Shee ae i
7.

(b) Be authorized to represent each of the agencies and institu-
tions. xhich propose to cooperate in planning for and the development
and operation of a Regional Medical Program. t

.

  
   
ee

a
.£

51b

ERT

 
 

Se

o
%

\

coerce

51b.

. 104 Application.
mae (a) An application for grant under this subpart shall be submitted

‘to the Secretary in such form and manner and at such time as the
Secretary may prescribe.

£(b) ‘Such application shall be executed by an individual authorized

aA £ to act for the applicant, and to assume on behalf of the applicant,

the obligation imposed by the terms and conditions of any award,
including the Regulation of this subpart.

(c) In addition to any other pertinent information which 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 agencies and institutions participating in the
program, the geographic area to be served by the program, the co-
operative arrangements in effect, or intended to be made effective,
among the participating agencies and institutions, and the justi-
fication, supported by a budget or other data, for the amount of
funds requested. ot

105 Approval of Applications.

(a) General. An application for a grant under this subpart may
be approved by the Secretary only upon recommendation of the
National Advisory Council, and only if he makes each of the
following determinations: - . +

 

sae

“((1) +~That the application contains or is supported by >
reasonable assurances that Federal funds paid pursuant to
such grant will be used only for the purpose for which paid
and in accordance with the applicable provision of the Act
and the Regulation of this support.

   

(2) That the application contains or is supported by reason-
able assurances that the applicant will provide for fiscal
control and fund accounting procedures in accordance with 51b.
(3) That the application contains or is supported by
yeasonable assurances that the applicant will make reports
and keep records in accordance with Slb.s

(4) That the applicant is situated within geographical area

that forms an economic and socially related region, taking

into consideration such factors as present and future popu- =<
lation trends and patterns of growth; location and extent of 3S
_jransportation facilities and systems; presence and distri- |
bution of educational, medical and health facilities and
programs, and other activities which in the judgment of the :
Secretary are appropriate for carrying out the purposes of : '

the Act. ’ Ye

4
3

 

“x, (b) Planning. In addition to the determination required by
“s, “paragraph (a) of this section, an application for a grant which

% includes planning activities under section 903 of the Act may

* be approved by the Secretary only if he finds that the applicant

f jhas designated a Regional Advisory Group which meets the require-

[ ¢ments of 51b. 108.

e. nad

i

(ASTET NATERERONS ERT

SSS CPT

te,

(c) Establishment and Operation. In addition to the determin-
ation required by paragraph (a) of this section, application for
a grant which includes establishment and operational activities
under section 904 of the Act may be approved by the Secretary
only ‘if “he,makes each of the following determinations:

 

i 4G

(1). That the application contains or is supported by
Yeasonable assurances that Federal funds paid pursuant to
such grant will not be used to support funds that are other-
wise available for establishment and operation of the
Regional Medical Program with respect to which the grant is
‘made.

(2) That the application has been recommended by the

Regional Advisory Group.
(3) That opportunity has been provided, prior to the recom-

© mendation of the Regional Advisory Groups, for consideration
of the application by each public or nonprofit private agency or
organization which has developed a comprehensive regional,
metropolitan area, or other local area plan referred to in
section 314(b) of the Public Health Service Act covering any
area in which the Regional Medical Program for which the
application is made will be located. ( /)

fat

adc A NE Bae

Ar fot ’
ithe Be Cooke tt

Sib. 106 Priority of Regional Medical Programs.

   
 

In determining priority among approved applications for grants
for Regional Medical Programs, the Secretary will take into account
the following: i pers: |

. i we ° r
(a) The relative extent to which the proposed Regional Medical

ge y

.’ (1) Link and strengthen the ability of multiple health
institutions and professions to provide care in the Title IX
diseases; joss so nace eas

/ (2) Provide early increases in the quality and accessibility, )
and. moderation of the cost, of care in the Title IX diseases,

/ (3) More broadly disperse new or improved knowledge and
treatment of Title IX diseases so that larger numbers of
@ persons will receive better care; a)

NOD a ERM,
PI REI a =
4

aN (4) Lead to increased utilization and effectiveness of

% community health facilities and manpower, especially new or
existing kinds of allied health personnel, so as to alleviate
maldistribution of health services in the Title IX diseases;

4/ /(S5) Include health maintenance, disease prevention, and

early detection activities as integral components;

L- (6) Provide for expanded ambulatory care and outpatient
diagnosis and treatment;

/ ie(P=-Strengthen’ and improve the relationship between primary
\and “secondary care so as to produce greater continuity and
laccessibility of care; and
i Kee ae

'(8)~*Be supported by local, State and other non-Federal
funds.’ *, ,
ow BR,

(b) ‘The relative effectiveness of the organizational structure

of the Regional Medical Program, including the extent to which

(1) All health related interests, institutions, and profes-
sions in the geographic area to be served are actively
articipating in the program;

(2) Organizational planning and activity are carried out at
i local level; and. yy
F “ 7 ale ad ¥
Lope comriay, %

(3) ‘There is systematic and ongoing identification and
assessment of needs, problems, -and resources.

(c) In the case of an application for continuation support (in
addition to the criteria listed in paragraphs (a) and (b) of

this section) i

 

(1) Whether the Regional Medical Program has established
its own goals, objectives, and priorities. ~ | |
(2) The extent to which activities previously undertaken
with the aid of funds under the Act have been productive in

terms of the specific ends sought to be achieved; and

(3) The extent to which activities stimulated and previously
supported by funds under the Act have been or will be supported
under other health care financing systems. po

  

Sib. 107 Grant Award. :
(a) Within the limits of funds available for such purpose, the

Secretary may award grants with respect to those applications fg
Ay

i
fs Ee HMR ee i

Sa

ae?

ae
5

@ (“na for the planning, establishment and operation of Regional Medical
“, ”: Programs which will in his judgment, after the application of the
\ priority consideration set forth in 51b. 106, best promote the

purposes of the Act. —

A) The amount of any award shall be determined by the Secretary
ee on the basis of his estimate of the sum necessary to carry out
' the approved activities.

 

 

Ee
{Secor wmeremes
i al Atta gate LARSEN

(c) All grant awards shall be in writing, and shall set forth the
amount of funds granted and the period for which support is
recommended? ~_

d ‘ y %
(d) Neither the approval of any application nor any grant award
shall commi’t,.or obligate the United States in any way to make any
additional, supplemental, continuation or other award with respect
to any approved application or portion thereof. For continuation
support, grantees must make separate application annually at such
times and in such form as the Secretary may direct.

51b. 108 Approval and award of funds for specific operational projects.

(a) Except as provided in subparagraph (b) of this section,
funds for specific operational projects within a grant for

@ establishment and operation of a Regional Medical Program must. be
specifically approved by the Secretary upon the recommendation
of the National Advisory Council, in accordance with the priorities
set forth in 51b. 106 of this subpart. .

pete # 4
(b) The Secretary may authorize any recipient of a grant for
establishment and operation of a Regional Medical Program to approve,
within the limits of available funds awarded to such grantee for
such purpose, specific operational projects where he determines,
upon the recommendation of the National Advisory Council, that such
grantee and such Regional Medical Program have satisfied the
following requirements: i iif h
Pm T
(1) Application. There must be established within the Regional
Medical Program a standardized application form and procedures,
dpproved by the Secretary, for the submission of applications
for funds for operational projects.

(2) Review criteria and priorities. Technical review criteria
and program priorities, approved by the Secretary, must be uw.
established and made available to all prospective applicants
within the geographic area to be served by the Regional - i 4
‘Medical Program. a |

 

 

eat
6

 

a (i) Technical review criteria shall include, but need
% _ not be limited to the following:

- |
/ ‘ (A) The feasibility of the proposed project;

%
4
i
} MY (B) The quality of the personnel and facilities
cman to be devoted to the project;

(C) Financial and other resources available to
support the project; and

oo

} pons) The adequacy of the proposed method of evalu-

i; + ation of the project.

It

f 3
E of

5 p=(ii) Program priorities must reflect the needs of the
; | geographic area served and be consistent with the

rg
| (priorities set forth in 51b. 106 of this subpart.

(3) Technical Review. There must be established within the
Regional Medical Program, in addition to the Regional Advisory
Group, a system for obtaining review of application by
‘echnical review committees or groups acceptable to the

ecretary. 4 %
f 4

t
k

© (i) The composition of such committee or group must
’ | be such that their technical, scientific, and professional
expertise adequately covers the scope of their respective
review functions. = 4

Sastre Ta Symes eet

(ii) The manner in which the members of such committees

\ are chosen and the procedures governing the frequency

\ and conduct of meetings must be in writing and be approved
_ by the Regional Advisory Group. pvsssesenmny

By,

(iii) Written summaries of the findings and recommendations
of the technical review committees must be made available
to the Regional Advisory Group prior to’ the meeting at

which the applications involved will be considered by the

; Regional Advisory Group. why
(4) Review by areawide health planning agencies. Opportunities
must be provided, prior to action by the Regional Advisory Group,
for consideration of each application by each public or non-

profit private.agency or organization which has developed a -#-»-==
comprehensive regional metropolitan area, or other local area ar
plan referred to in section 314(b) of the Public Health Service

Act covering any area which will be served by the proposed
project. Copies of any comments made by such agencies shall: j

be furnished to the Secretary on request. i i

e | dy

  
7

 

ar
8

JUEUAR a Ee

@ C oN (5) Approval of applications. Applications shall be
approved only upon the recommendation of the Regional
‘ BOWASORY Group...

SEY SVE TE? >

§

} (6) Project ranking and funding determination. There

a ‘must be established a priority ranking system, based upon

pat the program priorities established pursuant to subparagraph
-. (2) of this paragraph and approved by the Secretary, to be
applied by the Regional Advisory Group in determining the

order in which approved projects will be funded.

(7) Ap eal procedure. In the case of any review procedure
lin which an application may be disapproved by a group other
\that the Regional Advisory Group, a written procedure,
approved by the Secretary, must be established under which
an applicant whose application is so disapproved may request
appeal of such disapproval by the Regional Advisory Group.
:The levels of review under such procedure must be clearly
described, and copies of such procedure should be made
available to all applicants.

'

~

51b. 109 Regional Advisory Group.

Each rant award under this subpart is subject to the condition

that there has been established in or for the geographic area to be
@ served by'the Regional Medical Program a Regional Advisory Group which
meets the |requirements of this section.

(a) The membership of the ‘Regional “Advisory Group shall be
sufficient in number of insure adequate community orientation,
and shall include practicing physicians and members of other
health ‘professions; medical center officials; hospital adminis-
trators; representatives from appropriate medical societies and
voluntary health agencies; representatives of each agency adminis-
tering or supervising the administration of a State plan approved |
under section 314(a) of the Public Health Service Act for a State
in which the geographic area served by the Regional Medical Program
is located, and of each public or nonprofit private agency or ,
organization which has developed a comprehensive areawide health
plan referred to in section 314(b) of the Public. Health Service

Act for an area in which such geographic area is located; repre-
sentatives of other organizations, institutions, and agencies
concerned with activities of the kind to be carried on under the
program (including as an ex officio member, if there is located
in such geographic area 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 Regional Advisory Group as the representative of
such hospitals or other health care facilities); and members of
: the public familiar with the need for and financing of the

@ services to be provided under the program.

 

BOWeogs no as week gE
PEPE tsp
8

@ Ee AEROS Ria “oe, . ; . .
“games (b) Members of the Regional Advisory Group shall meet as often
i %, “as necessary, but not less often than four times per year, for
the purpose of

x

é

L

_- ra the plan for the establishment and operation of the Regional
” Medical Program; and

pk . . .
/ 7 (1) Advising the grantee in formulating and carrying out:

(2) Reviewing, and making recommendations with respect to,
applications for funds for specific operational projects
within the Regional Medical Program.

A i,

Sib. 110 Payments. :
Poy wf .

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 incurred or to be incurred, to the
extent he determines such payments necessary to promote prompt
initiation and advancement of the approved program. .

51b. 111 Use of grant funds.

(a) Any funds granted pursuant to their subpart, and any non-
Federal funds required as a condition of the grant to be expended

© in the project, shall be expended by the grantee solely for carrying

out the approved program in accordance with the Act, the Regulations

of this subpart, the terms and conditions of the award, and the
cost principles set forth in the Department of Health, Education,
and Welfare Grants Administration Manual (available for purchase at
the Government Printing Office (GPO 894-523 )).

(b) Prior approval by the Secretary of revision of the budget and
program plan is required whenever there is to be a. Significant
change in the scope or nature of program activities. ;

tesit
yf
51b. 112 Nondiscrimination oe |
y germ, |

Attention is called to the requirements of Title VI of the Civil
Rights Act of 1964 (42 USC 2000d; 78 Stat. 252) which 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. A regulation imple-
menting such Title VI, which is applicable to grants made under this ces»
subpart, has been issued by the Secretary of Health, Education, and ™
Welfare with the approval of the President (45 CFR Part 80).

 

 

&
a

5lb. 113 Inventions or discoveries.

|

@ A grant award is subject to the regulations of the Department of.) 4,
Health, Education, and Welfare as set forth in 42 CFR Parts 6 and 8 , «sad
9

 
 

RRC
She.

‘eas amended. Such Regulations shall apply to any activity for which
grant funds are in fact used whether within the scope of the project
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 obligations are

4 ‘\e=wcontinued or entered into and that all personnel involved in the

woe cunorted activity are aware of and comply with such obligations.

' Laboratory notes, related technical data, and information pertaining

to inventions and discoveries 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.

 

qonmerentey
METS RT

armameregonmanere nrg ft

51b. 114' Publications and copyright.

Except as may otherwise be provided under the terms and conditions
of the award, the grantee may copyright without prior approval any
publications, films or similar materials developed or resulting from a
project supported by a grant under this subpart, subject, however, to a
royalty-free, nonexclusive, and irrevocable license or right in the
Government to reproduce, translate, publish, use, disseminate, and
dispose of such materials and to authorize others to do so.

%

® 51b, 115 Records, reports, and inspection.

. (a) records and reports. Each grant awarded pursuant to this.
subpart shall be subject to the condition that the grantee shall
maintain such operational and accounting records, identifiable by
grant number, and file with the Secretary such operational and
fiscal reports relating to the use of grant funds, as the Secretary
may find necessary to carry out the purposes of the Act and the
Regulations. All records shall be retained for 3 years after the
close of the budget period. Such records may be destroyed at the
end of such 3-year period if the applicant has been notified of the
completion of the Federal audit by such time. If the applicant has
not been so notified such records shall be retained (1) for 5 years
after the close of the budget period or (2) until the grantee is ,
notified of the completion of the Federal audit, whichever comes ©
first., In all cases where audit questions have arisen before the
expiration of such 5-year period, records shali-be retained until
resolution of all such questions.

(b) Inspection and audit. Any application for a grant under this
subpart shall constitute the consent of the applicant to inspections ~~~
of the facilities, equipment and other resources of the applicant a
at reasonable times by persons designated by the Secretary and to
interview with principal staff members to the extent that such
resources and personnel are, or will be, part of the project. In ;

. addition, the acceptance of any grant under this subpart shall con-,

@ stitute the consent of the grantee to inspections and fiscal audits...
by such persons of the supported activity and of progress and fiscal

records relating to the use of grant funds.

 
10

“b1b, 116 Additional conditions.
ee

‘ The Secretary may with respect to any grant award impose additional
conditions prior to or at the time of any award when in his judgment
such conditions are necessary to assure or protect advancement of the
«approved project, the interests of public health, or the conservation

“of grant funds.

mice
i
q
cia
4
&
\
L

 

51b. 117 Suspension and early termination.

Whenever.the Secretary finds that a grantee has failed ina
material respect to comply with the Act or with the terms of the
grant, including the Regulations of this subpart, he may, on reason-
able notice to the grantee, withhold further payments, and take such
other action, including the termination of the grant, as he finds
appropriate to carry out the purposes of the Act and the Regulations.
Noncancellable obligations of the grantee properly incurred prior to
the receipt of the notice of termination will be honored. The grantee
shall be promptly notified of such termination in writing and given the
reasons therefore.

 

\
© fR ‘
Pix
“ £ % %
/ Censinendl 4
: %
of &y ¢ ‘sy
froma SDRET TR
PRET  E
qummurum f
te ;
oud ;
Ln : .
Lucas i
pee
‘ed r
a _ . 3

tad

 
c

RMPS SUGGESTED ADDITIONS TO PROPOSED REGULATIONS

 

A. * Grantee-RAG-Geerdinater Relationships

 

“RMP grantee organization, and the Chief Executive Officer

* (program coordinator) and their relationships to one another
shall be in accord with such requirements as the Director of
Regional Medical Programs Service may prescribe. In general,
the RAG will be responsible for formulating the program policies,
objectives, and priorities of an RMP; the grantee organization
will .be..responsible for managing the RMP grant in a manner that
will-implement the program established by the RAG; and the Chief
Executive Officer will be responsible for the day-to-day direction
and management of the RMP in a manner that accords with the
program policy established by the RAG and the administrative and
other procedures of grantee organizations.

¥

f ‘

' ; The respective responsibilities of the Regional Advisory Group,
i

alt
i
b

t

g

¢

#
~ 4
L
E
#
2 ae

 

oe

; 48s,
ce

B. Section 910°.”

1. Funds awarded under Title IX may be used to carry out the
purposes of Section 910.

2. A Regional Medical Program may support activities authorized
by Section 910 subject to the policies promulgated by the
@ ecretary. No special application is required unless other-
wise specified by RMPS. %
e* accnaee!! y
3. Public or nonprofit private agencies, institutions, or com-
binations thereof other than Regional Medical Programs may
request special project grants to support activities authorized
by Section 910.
\
4. Contracts may be awarded by RMPS to Regional Medical Programs
and other organizations pursuant to Section 910 to support
any activity authorized under Title IX. At the option of the :

Secretary, contracts may be negotiated in lieu of grants.

STERIC SO

C. Construction
No funds shall be authorized to be expended for-construction
unless specifically approved in advance by the Secretary.

Construction projects shall be subject to the Regulations of
the Department which are applicable to the type of facility for “=”
the construction of which a grant is made, specifically the | - 3
Regulations relating to Hospitals and Medical Facilities ; 5a.

 

 

Health Research Facilities , and Medical Teaching Facilities  ;
___, and the General Standards of Construction and Equipment i 3
thereunder. oO, , ; i