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shown that the provision of a dietary supplement in the form of keto acids,
building blocks which the body can use to make needed protein, decreases the
work required of the kidney. These substances can serve as building blocks
for protein and under these conditions there is a marked reduction in the
quantity of waste products from the diet requiring excretion by the kidney.

Use of the treatment program in chronic uremic patients significantly prolong-
ed the ability of their markedly diseased kidneys to get rid of the daily waste
products, thereby prolonging the time before they require treatment by hemo-
dialysis.

Since this treatment markedly reduces the rate of waste material accumulation
from dietary intake, it offers the potential for reducing the frequency of
dialysis in patients who are already on dialysis. If this treatment regimen
can be shown to be practically applicable to large numbers of patients on hemo-
dialysis, it will thus permit existing dialysis facilities to treat a greater
number of patients and will also improve the quality of life for the patient
on dialysis since he will be required to spend less time on the hemodialysis
machine.

Premature Infants

The seriously ill premature and neonate are in a very critical situation due
to rapid and profound changes in basic physiological and biochemical parameters
as they attempt to adapt to extrauterine life. Because of this, they must be
closely monitored and repeated blood tests are frequently necessary. Despite
the fact that only small quantities of blood are necessary for various tests,
the infant requires frequent replenishment of its rapidly dwindling blood vol-
ume. In the past, each time an infant required a small transfusion (10-30 ml),
a complete 500 ml unit of whole blood was utilized, thereby contaminating the
remaining 450+ ml and rendering it unsuitable for further use. Therefore,
various methods of blood transfusions have been developed throughout the coun-
try to make a more efficient use of donated blood.



100



One of the techniques utilized in the nurseries is to establish a walking do-
nor blood program wherein hospital-based donors are used to donate small quan-
tities of blood to needy infants. A "stable" of donors is screened periodi-
cally to check blood type and antibody formation, to detect whether or not
the donor has developed antigen for hepatitis virus, and antibodies to various
viral illnesses and syphilis. These donors are then assigned on a randomized
basis to neonates who need repeated transfusions. A GCRC was one of the first
in the United States to develop such a program, and the only unit to evaluate
the efficiency and potential dangers and complications of such a program.

V. Future Objectives and Trends

The President's Budget request for FY 1976 proposed $41.6 million for the GCRC
Program. This compares with $42.2 million appropriated in FY 1972 and an ap-
propriation level of $42.3 million for 1975. The history of appropriations,
service patient credits, Council recommendations, and expenditures can be seen
in Figure 1 (see page 90 ) .

During the early 1970s, several factors combined to cushion the impact of the
rapidly escalating cost on the GCRC Program budget. These included the phas-
ing out of support to ten Centers in 1969. Also, in 1970, a policy of charg-
ing "hospital sick" patients on the GCRCs was instituted, which was successful
in reducing Program-wide costs by nearly 10%. Additional measures included a
research out-patient policy implemented in 1970 which decreased hospitaliza-
tion expenditures and has reduced the bed requirements and hospitalization
costs in many Centers; and a discrete unit costing method by which the Pro-
gram essentially rent3 hospital space for research. The latter has helped
hold down facility costs and has resulted in a better management of ancillary
services purchased by the unit.

Between 1970 and 1973, the Program was able to accumulate a substantial poten-
tial balance in various grant accounts. This is shown in Figure 1, where a-
vailable funds appropriated plus service patient credits exceeded expenditures.
It should be noted that these potential balances do not materialize until the
grant account is closed, a process which is totally dependent on the availa-
bility of finalized hospitalization rates. Moreover, these balances are cur- po
rently being rapidly consumed by an expenditure level which exceeds available
funds, a situation not unlike that occuring in 1969. It is projected that an
estimated $3.5 million remaining in these accounts will become available during
FY 1976, thus exhausting the savings accumulated between 1970 and 1973.

Further substantial savings have been achieved by a 25% decrease in the number
of personnel supported, from 2,297 positions in 1969 to a current level of
1,722 positions. The number of supported beds has been similarly decreased
from 1,051 in 1968 to 827 in 1975. During this same period, the cost per po-
sition and cost per patient day have nearly doubled (see Table VI on page 89)



CO



It is now apparent that with the continuing cost escalation, without concomi-
tant budget increases, further substantial reduction in GCRC resources must
now be undertaken and further reductions in number of extramural dedicated
research beds will occur. Efforts to recover third party payments for both
research and nonresearch patients will be intensified. However, after all
possible steps to conserve Program funds have been taken, it is estimated that
support for 8 to 12 Centers will have to be phased out during FY 1976 and FY
1977 to establish a balance between expenditures and available funds.



102






Fiscal Year 1975

Annual Report

General Research Support Branch

Division of Research Resources



The General Research Support Branch in FY 1975 administered the General
Research Support Grant, the Biomedical Sciences Support Grant, the Health
Sciences Advancement Award, and the Minority Biomedical Support programs.

GENERAL RESEARCH SUPPORT GRANT
AND
BIOMEDICAL SCIENCES SUPPORT GRANT
PROGRAMS

T 6 Sf J esearch Support Grant (GRSG) program was authorized by Public
Law 86-798 which was approved September 15, 1960, and the first awards were
made in FY 1962. Recipients of GRSGs are medical and other health profes-
sional schools, hospitals, and other non-academic research institutions.
In 1966, the companion Biomedical Sciences Support Grant (BSSG) program was
initiated. This program is conceptually identical to the GRSG program, but
provides funds to academic institutions other than health professional
schools.

The general program objective is to strengthen, to balance, and to stabilize
Public Health Service supported biomedical and behavioral research programs
by providing flexible institutional funds on a formula basis to non-Federal
public and non-profit private health professional schools, universities,
hospitals, research organizations and other institutions actively engaged in
biomedical and behavioral research. These funds are to complement and to
enhance the effectiveness and efficiency of biomedical and behavioral research
in those institutions. The most distinguishing feature of the program is the
opportunity provided for grantee institutions to exercise on-site judgment
regarding emphasis, specific direction and content of activities supported,
thus enabling the institution to respond quickly and effectively to emerging
opportunities and unpredictable requirements, to enhance creativity, to
encourage innovation, to provide for pilot studies and to improve research
resources, both physical and human.

This program thus recognizes the need to share resources and to respond to
opportunities that develop during the course of active, diverse biomedical
and behavioral research programs and to contribute to the stability of the
national research effort.

Grants from this program are intended to support primarily those biomedical

and behavioral research activities not readily or normally supported by

PHS categorical research grant programs. Examples of areas of emphasis are:

• Pilot projects

• Initial investigations in new fields and in fields new to the
investigator

103



• Unanticpated opportunities and requirements

• New and more effective patterns of use of resources within and without
the grantee institution

» Central shared resources

Enhancement of investigator's biomedical research skills

• Expansion of research capabilities through improved research
opportunities for minorities and women

• Animal welfare improvement

Fiscal and Administrative Considerations

Tables I and II show how GRSG and BSSG funds were used in FY 1973.



TABLE I
FY 1973 Expenditure of General Research Support Grant Funds by Activity

Number Dollars (in thousands ) % of Total Dollars
RESEARCH PROJECTS 5,706



New Pilot Proj . 1,118

Cont. Pilot Proj. 1,244

New Reg. Res. Proj. 824

Cont. Reg. Res. Proj. 2,520



$ 2,887

3,005

3,438

10,050



10.4
10.9
12.4
36.3



CENTRAL RESOURCES

Animal Facilities
Computer Facility
General Use Equip .
Instrument Shop
Central Lab. Facility
Photog. and Med. Arts
Other



1,461
680
990
398

1,265
206

1,260



5.3
2.5
3.6
1.4
4.6
0.7
4.6



RESEARCH TRAINING



1,165



4.2



OTHER ACTIVITIES
Total



852



$27,657



3.1



100.0



104



TABLE II

FY 1973 Expenditure of Biomedical Sciences Support Grant Funds by Activity

Number Dollars (in thousands ) % of Total Dollars

RESEARCH PROJECTS 1,846

New Pilot Proj. 425

Cont. Pilot Proj. 404

New Reg. Res. Proj. 393

Cont. Reg. Res. Proj. 624



$ 601


13.5


542


.12.5


779


17.6


1,102


24.9



CENTRAL RESOURCES

Animal Facilities
Computer Facility
General Use Equip .
Instrument Shop
Central Lab. Facility
Photog. and Med. Arts
Other



126
38

364
11

385

6

98



2.9
0.8
8.2
0.2
8.7
0.1
2.2



RESEARCH TRAINING



217



4.9



OTHER ACTIVITIES
Total



154



$4,423



3.5



100.0



Tables III and IV show for the GRSG and BSSG programs respectively, (1) the
trend in allowable research grants awarded by PHS to eligible GRSG or BSSG
institutions (entitlement) since the initiation of the programs, (2) the
trend in award funds, and (3) the relation between entitlement and awards.

It can be seen from these data that there has been a steady upward trend in
entitlement for the GRSG/BSSG programs. The GRSG entitlement base has
increased seven fold since the start of the program in FY 1962, while the
amount of money made available for the program in FY 1975 is less than twice
the amount awarded in FY 1962. In FY 1962 GRSG grantees received 18.48c for
each dollar of entitlement. This figure dropped to a new low of 4.91c in
FY 1975. The same trends are reflected in the BSSG program data. In FY 1975
a new low of 2.86c was paid for each dollar of BSSG entitlement.



r*



105



TAB I.I''. I I I

CKNKRA1, RESEARCH SUPPORT ( I RANT I'ROCRAM

Trends in I'HS Research (Irani Awards

(Entit lements) 1/ and in Ceneral Research Support (Irani Funds, FY 1962-1975



Fiscal Year



I'HS Awards
(Kilt i t lement)



1962


$108


2 34


000


1963


192


408


000


1964


24 1


426


000


1965


286


832


935


1966


320


415


167


1967


354


893


188


1968


39 3


366


592


1969


44 1


064


040


1970


448


080


707


1971


430


721


426


1972


495


806


,184


1973


577


966


,843


1974


667


165


273


1975


756


,111


,529



ORSC Funds


Ratio (%)


Awarded


CRSC/F.nt i Llement


$20,000,000


18.487.


30,000,000


15.59


35,000,000


1 4 . 50


4 3,985,365


15.33


39,200,000


12.23


41 ,700,000


1 1.75


48,174,445


12.25


48,200,000


10.93


45,802,000


10.22


43,423,000


10.08


44,298,000


8.93


46,277,000


8.00


38,242,000


5.73


37,116,205


4.91



1/ Previous fiscal year research grant awards received from the PUS by
dRSd awardees.



TABLE IV



I', IOMF.DICAI. SCIENCES SUPPORT CRANT PKOCKAM
Trends in PUS Research Crant Awards
(Entitlements) and in BSSC Funds, FY 1966-1975



1/



Fiscal Year



PUS Awards
(F.nt i t lement)



1966


$ 80,233,656


1967


87,564,767


1968


108,925,527


1969


1 19,007,903


1970


12 3,150,660


1971


122,385,049


1972


138, 129, 124


1973


160,949,957


1974


174,303,033


1975


199,865,5 57



SSC Funds


Ratio (7)


Awarded


BSSC/ En t i t lement


5,000,000


6.237.


6,000,000


6.85


7,500,000


6 . 8')


1 ,500,000


6.30


7,125,000


5.79


6,7 7 7,000


r . 54


6,914 ,000


j.01


7,223,000


4.49


6,007,000


3.45


5,7 14,795


2.86



1/ Previous fiscal year research grant awards received from the 1*1 IS by
BSSC awardees.



106



P.L. 86-798 states that up to 15 percent of the amount provided for research
grants for any fiscal year to the National Institutes of Health may be used
for the General Research Support program. Reports of appropriation hearings
in both Houses of Congress have repeatedly affirmed the congressional intent
that ultimately the 15 percent level be made available, but this goal has
never been reached. As shown in Table V, a high of 8.3 percent was reached
in FY 1969. Since then the level has declined to 3.7 percent in FY 1975.



TABLE V



GENERAL RESEARCH SUPPORT PROGRAM
(Dollars in Thousands)









If


15% were made


Amount made




Percent of


Funds


Available for


available for


available for


available GRS


NIH Research


Grants ±'


GR£


> Program


GRS Program 1/


funds to total


1966


$


604,377




$ 90,657


$45,200




7.5


1967




681,197




102,180


51,700




7.6


1968




727,366




109,105


59,700




8.2


1969




729,230




109,385


60,700




8.3


1970




744,061




111,609


57,677




7.8


1971




765,510




114,827


54,200




7.1


1972




901,119




135,168


55,212




6.1


1973




820,913 1/




123,137


60,700


2/


7.3


1974


1


,091,795




163,769


45,149


3/


4.1


1975


1


,142,782




171,417


42,957




3.7



1/ Thru 1972 includes NIMH

2/ Includes 33.5 million impounded funds

3/ Excludes Minority Biomedical Support program funds






Tables VI, VII, and VIII summarize the distribution of GRSG and BSSG awards
by categories of institution,' size of award, range and average size of
award, and amounts of funds awarded each year for Fiscal Years 1968 through
1975. The average size of awards has declined steadily over this period
in parallel with a decline in the total amounts of funds awarded, and modest
increase in number of grantees.






107



TABLE VI
GENERAL RESEARCH SUPPORT GRANT PROGRAM



Number of Grantees by Type for the General Research
Support Grant Program FY 1968 - 1975



Type of














Revised




Grantee


I'Y


FY


FY


FY


FY


FY


FY


FY


Inst.


1968
95


1969


1970


1971


1972


1973


1974


1975


Medicine


99


100


100


101


104


104


107


Dentistry


49


49


49


33


34


34


33


34


Osteopathy


5


5


5














1


Pub. Health


12


12


12


12


12


12


12


12


Pharmacy


10


12


15


15


16


14


12


17


Ve t . Med .


15


17


17


17


16


15


14


15


Nursing











2


4


3


4


5


Allied Health

















1


1


1


Hospitals


71


75


79


76


79


71


66


71


Health Dept.


3


3


3


2


2


2


2


2


Res. Inst.


51


58


64


69


75


71


70


75



TOTAL



311



330



344



326



339



327



318



340



108



TABLE VII



GENERAL RESEARCH SUPPORT GRANT PROGRAM

Distribution of General Research Support Grants by Size of Awards
and Funds Awarded for Fiscal Years 1968 Through 1975

Number of Institutions

Size of Grant FY FY FY FY FY FY FY '. FY
(in thousands ) 1968 1969 1970 1971 1972 1973 1974 1975

Under - $ 30.0 27 30 49 34 46 17 29 54

$ 30 - 49.9 54 46 47 51 54 67 63 57

50 - 99.9 74 80 85 77 78 69 71 73

100 - 149.9 41 49 41 50 36 41 47 54

150 - 199.9 40 36 34 36 45 .41. 48 45

200 - 249.9 21 21 26 25 26 36 22 20

250 - 299.9 19. 29 31 25 21 19 38 37

300 - 349.9 13 12 8 8 10 12

350 - 399.9 13 9 23 20 23 25

400 - 449.9 9 18

450 - 499.9

500 - 599.9



TOTAL



311



330



344



326



339



327



318



340



Amounts (In Thousands)



Grant Range
(All Inst.)


FY
1968


FY
1969


FY
1970


FY
1971


FY
1972


FY
1973


FY
1974


FY
1975


Low

High

Average


13
424
155


12
429
146


5
396
133


11
383
133


12
367
130


11
359
141


16
280
120


15
255
109



Total General Research Support Grant Funds Awarded (In Millions)



FY
1968



FY
1969



FY
1970



FY
1971



FY
1972



FY
1973



FY
1974



FY
1975



Total Funds

Awarded $48.2 $48.2 $45.8 $43.4 $44.3 $46.2 $38.2 $37.2



109



TABLE VIII

BIOMEDICAL SCIENCES SUPPORT GRANT PROGRAM

Distribution of Biomedical Sciences Support Grants by Size of Awards
and Funds Awarded for Fiscal Years 1968 Through 1975



Number of Institutions



A



Grant Range
(All Inst.)

Low

High

Average



Amounts (In Thousands)



FY
1968



FY
1969



$36 $ 29

219 220

74 68



FY
1970

$ 15

199

63



FY
1971

$ 12

210

61



FY
1972

$ 15

212

59



FY
1973

$ 27

221

63



FY
1974

$ 23

187

56



Size of Grants


FY


FY


FY


FY


FY


FY


FY


FY


(In thousands)


1968


1969


1970


1971


1972


1973


1974


1975


Under - $ 30.0





1


8


8


14


7


16


27


$ 30 — 49.9


27


36


35


36


36


38


42


55


50 - 99.9


60


59


59


57


59


53


45


34


100 - 149.9


11


11


9


9


5


11


1


2


150 - 199.9


3


2


2


1


2


2


4


3


200 - 249.9


1


1





1


1


2








Total No. of


















Grants


102


110


113


112


117


113


108


121



FY
1975

$ 19

165

47



Total Biomedical Sciences Support Grant Funds Awarded (In Millions)



FY
1968



FY
1969



FY
1970



FY
1971



FY
1972



FY
1973



FY
1974



FY
1975



Total Funds
Awarded



$7.5 $7.5 $7.1 $6.7 $6.9 $7.2 $6.0 $5.7



110



Program Funding

The FY 1973 appropriation for the GRSG/BSSG programs was $53.5 million. Of
this amount, $33,576 million was impounded, and then released in FY 1974.
The President's budget for FY 1974 called for $9,500,000, but the final
allocation was $44,232,000. The President's budget for FY 1975 requested
no funds for the GRSG/BSSG program. However, $43,000,000 was appropriated
for the programs in FY 1975.

The FY 1975 DHEW Appropriation Bill allocated $43,000,000 to the GRSG/BSSG
program. The administration proposed a deferral/rescission action for the
entire $43,000,000, but the proposed rescission was not accepted by the
Congress. FY 1975 GRSG awards were not made until March, three months later
than usual, because it was necessary to know the outcome of the rescission
request. The President's budget for FY 1976 again shows no funding for the
GRSG/BSSG program. Grantee institutions have been unable to plan their
research programs effectively in the face of these uncertainties. Expendi-
tures of grant funds have been delayed and reduced because of reduced and
delayed funding, and uncertainty of future funding.

Program Plans

The Subcommittee on Appropriations for Labor, and Health, Education and
Welfare, of the House of Representatives, stated during the Fiscal Year 1975
appropriations hearings, H. R. Report No. 93-1140, pages 45-46, that changed
circumstances and the passage of time, while not diminishing the need for
General Research Support, may have modified the program function and need,
and therefore directed that NIH reconsider the General Research Support
formulas and guidelines with a view to revising eligibility, and allocation
and usage of the grants. The Senate Appropriations Subcommittee endorsed
the request and asked that consideration be given also to support of small
institutions (Senate Report No. 93-1146, page 67).



In response to these congressional directives, extensive study was made of
General Research Support program needs and desired changes by program staff
and program advisory groups, and public comment was received on proposed
changes. These actions culminated in recommendations for program modifica-
tion that were forwarded through the echelons of DHEW to each congressional
appropriations committee. The major changes that were recommended are:

1. Merge the General Research Support Grant (GRSG) and Biomedical
Sciences Support Grant (BSSG) programs into a single program,
a Biomedical Research Support (BRS) Grant program.

2. Establish a level of $200,000 in PHS research grants as the
criterion of eligibility for each institution. Current
regulations require $200,000 in NIH and NIMH research grants
for BSSG awards and $100,000 for GRSG awards.

3. Establish a new formula for the merged program with a maximum
award of $300,000.



Ill



73
CO



4. Limit to $500,000 the credit permitted for any one allowable
PHS grant to which the formula is applied.

5. Support of research salaries of tenured faculty would be permitted
only on a short-term basis provided it can be justified.

6. Supplementation of ongoing PHS research project grants would be
permitted only for unexpected or emergency needs.

7. Alterations and renovations of research facilities could be charged
to the grant not to exceed 20 percent of the BRSG award for the
current year, or $40,000, whichever amount is smaller.

8. Require each grantee to establish mechanisms acceptable to the
NIH to assure: broadly-based review for advice on the use of the
grant funds; wide dissemination within the grantee institution of
information about the availability of grant funds and accomplishments
of the grant; and policies and procedures for strong programmatic
and fiscal accountability.

9. Conduct periodic on-site evaluations to assess program performance,
and to re-evaluate program goals.

A Biomedical Research Development Grant (BRDG) program was also proposed as
a companion program to the Biomedical Research Support Grant (BRSG) program
to assist eligible institutions to establish specific capabilities for the
conduct of biomedical and behavioral research.

The purpose of the Biomedical Research Development Grant program would be
to enhance the achievement of the Federal commitment to discovery of new
knowledge necessary for better health through research contributions from a
broader array of institutions. The program is intended for those institu-
tions that currently have limited involvement in biomedical and behavioral
research, but possess the necessary potential and can justify such research
advancement in terms of the national interest and the NIH mission.

Eligible institutions would be those which receive less than $200,000 of
direct and indirect costs annually in PHS biomedical and behavioral research
grant support as required for the proposed BRSG program.

Biomedical Research Development Grants would be awarded on the basis of
detailed applications that describe institutional objectives for development
of biomedical and behavioral research capability, existing strengths and
weaknesses, and plans to achieve the objectives.

Up to 10 percent of the funds appropriated and apportioned each year for the
Biomedical Research Support Grant program (formerly the General Research
Support Grant and Biomedical Sciences Support Grant programs) , would be
designated for support of the Biomedical Research Development Grant program.

Although the Administration's FY 1976 budget message requested no funds for
GRSG/BSSG, because other biomedical research programs were judged to have a



112



higher priority, it is prudent to continue work on issues that confront the
GRSG/BSSG program because the details of the 1976 appropriation that
ultimately will be enacted cannot be foreseen. If funding is forthcoming for
FY 1976, it is planned to make program modifications as stated above.

HEALTH SCIENCES ADVANCEMENT AWARD PROGRAM

During FY 1975 the following grantees completed their Health Sciences
Advancement Award program:

University of Kansas
Duke University
Washington University

The Health Sciences Advancement Award program is now terminated. A total of



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