Full Text DK-93-020


NIH Guide, Volume 22, Number 14, April 9, 1993

RFA:  DK-93-020

P.T. 34

  Biomedical Research, Multidiscipl 

National Institute of Diabetes and Digestive and Kidney Diseases

Letter of Intent Receipt Date:  October 8, 1993
Application Receipt Date:  November 18, 1993


The National Institute of Diabetes and Digestive and Kidney Diseases
(NIDDK) invites applications for funding of three Clinical Nutrition
Research Unit (CNRU) grants to be competitively awarded in Fiscal Year


The Public Health Service (PHS) is committed to achieving the health
promotion and disease prevention objectives of "Healthy People 2000,"
a PHS-led national activity for setting priority areas.  This Request
for Applications (RFA),  Core Grants for Clinical Nutrition Research
Units, is related to the priority areas of nutrition, physical activity
and fitness, heart disease and stroke, cancer, diabetes and chronic
disabling conditions.  Potential applicants may obtain a copy of
"Healthy People 2000" (Full Report:  Stock No. 017-001-00474-0) or
"Healthy People 2000" (Summary Report:  Stock No. 017-001-00473-1)
through the Superintendent of Documents, Government Printing Office,
Washington, DC 20402-9325 (telephone 202-783-3238).


Applications may be submitted by domestic for-profit and non-profit
organizations, public and private, such as universities, colleges,
hospitals, laboratories, units of State and local governments, and
eligible agencies of the Federal government.  There must be in
existence at the applicant's institution an ongoing program of
excellence in biomedical basic and clinical research related to the
nutritional sciences, obesity, eating disorders and energy regulation.
The quality of the programs must be evident from the fact that they
have been awarded support through peer review competition.  Minority
individuals and women are encouraged to submit as principal
investigators.  Foreign institutions are not eligible to apply.


Support of this program will be through the NIH core center grant
(P30).  Responsibility for the planning, direction, and execution of
the proposed project will be solely that of the applicant.  Except as
otherwise stated in this announcement, awards will be administered
under PHS grants policy as stated in the PHS Grants Policy Statement.
The receipt of three competing continuation applications is
anticipated, which will be in competition together with other
applications received in response to this announcement.  The
anticipated awards will be for five years and will be contingent upon
the availability of appropriated funds.  Requests for support must be
limited to no more than $700,000 in direct costs per year.  It is
anticipated that awards will average approximately $750,000 total costs
for the first budget period.


Approximately $2,250,000 has been set-aside for grants awarded under
this RFA.  NIDDK anticipates awarding three CNRU Grants in Fiscal Year
1995 on a competitive basis.


The NIDDK-supported CNRUs are part of an integrated program of
nutrition and obesity-research support provided by NIDDK.  These
centers have provided a focus for increasing collaboration and cost
effectiveness among groups of successful investigators at institutions
with established comprehensive nutritional sciences and obesity
research bases.

A CNRU, at a minimum, must comprise the following seven components and
also include other sources of support such as an NIH research project
grant (R01), NIH FIRST Award (R29), NIH Program Project (P01), NIH
Individual Fellowship (F32), and the NIH Institutional National
Research Service Award (T32) or other Federal and non-federal sources:

1.  Research with human subjects and populations;

2.  Laboratory investigations;

3.  Research training (funds to be derived from other sources*);

4.  Shared facilities and research services;

5.  Education programs for medical students, house staff, practicing
physicians, amd allied health personnel (funds to be derived from other

6.  Research components of nutritional support services; and

7.  Public information activities (funds to be derived from other

*  Funds to support these components may not be requested as part of an
application in response to this announcement.

The objectives of the CNRUs are to bring together investigators from
relevant disciplines in a manner that will enhance and extend the
effectiveness of research related to nutritional sciences, obesity and
related disorders.  A CNRU must be an identifiable unit within a single
university medical center or a consortium of cooperating institutions,
including an affiliated university.  The overall goal of the CNRU is to
bring together on a cooperative basis, clinical and basic science
investigators in a manner that will enrich the effectiveness of
nutrition and obesity research.  An existing program of excellence in
biomedical research in the area of nutritional sciences, obesity, and
related disorders is required.  This research should be in the form of
NIH-funded research projects, program projects, or other peer-reviewed
research that is in existence at the time of submission of a center
application.  Close cooperation, communication, and collaboration among
all involved personnel of all professional disciplines are ultimate
objectives.  Applicants should consult with NIDDK staff concerning
plans for the development of the center.

The CNRUs are based on the core center concept.  Cores are defined as
shared resources that enhance productivity or in other ways benefit a
group of investigators working in nutrition and obesity related areas
to accomplish the stated goals of the center.  Two other types of
activities may also be supported with center funding--a pilot and
feasibility program and an enrichment program. The pilot and
feasibility program provides modest support for new initiatives or
feasibility research studies.  This program is directed at new
investigators or established investigators in other research
disciplines where their expertise may be applied to nutrition and
obesity research.  The center grant may also include limited funds for
program enrichment such as seminars, visiting scientists, consultants,
workshops, etc.

Applicants from institutions that have a General Clinical Research
Center (GCRC) funded by the NIH National Center for Research Resources
may wish to identify the GCRC as a resource for conducting the proposed
research.  If so, a letter of agreement from either the GCRC program
director or Principal Investigator should be included with the



NIH policy is that applicants for NIH clinical research grants and
cooperative agreements are required to include minorities and women in
study populations so that research findings can be of benefit to all
persons at risk of the disease, disorder or condition under study;
special emphasis must be placed on the need for inclusion of minorities
and women in studies of diseases, disorders and conditions which
disproportionately affect them.  This policy is intended to apply to
males and females of all ages.  If women or minorities are excluded or
inadequately represented in clinical research, particularly in proposed
population-based studies, a clear compelling rationale must be
provided. This policy is applicable for every individual study or
project proposed in the application.

The composition of the proposed study population must be described in
terms of gender and racial/ethnic group.  In addition, gender and
racial/ethnic issues must be addressed in developing a research design
and sample size appropriate for the scientific objectives of the study.
This information must be included in the form PHS 398 (Rev. 09/91) in
Item 4 (Research Design and Methods) of the Research Plan AND
summarized in Item 5, Human Subjects.  Applicants are urged to assess
carefully the feasibility of including the broadest possible
representation of minority groups.  However, NIH recognizes that it may
not be feasible or appropriate in all research projects to include
representation of the full array of United States racial/ethnic
minority populations; i.e., Native Americans (including American
Indians or Alaskan Natives), Asian/Pacific Islanders, Blacks,

The rationale for studies on single minority population groups should
be provided.

For the purpose of this policy, clinical research is defined as human
biomedical and behavioral studies of etiology, epidemiology, prevention
[and preventive strategies], diagnosis, or treatment of diseases,
disorders or conditions, including but not limited to clinical trials.

The usual NIH policies concerning research on human subjects also
apply.  Basic research or clinical studies in which human tissues
cannot be identified or linked to individuals are excluded.  However,
every effort should be made to include human tissues from women and
racial/ethnic minorities when it is important to apply the results of
the study broadly, and this should be addressed by applicants.

If the required information is not contained within the application,
the application will be returned without review.


Potential applicants are strongly encouraged to submit a letter of
intent no later than October 8, 1993.  The letter of intent is to
include:  (1) names of the Principal Investigator/program director and
principal collaborators, (2) descriptive title of the potential
application, (3) identification of the organization(s) involved, and
(4) reference to the RFA number "DK-93-020."  The letter of intent is
to be sent to the Chief, Review Branch, NIDDK at the address listed

Although a letter of intent is not required, is not binding, and does
not enter into the review of subsequent applications, the information
that it contains is helpful in planning the review of applications.  It
allows NIDDK staff to estimate the potential review workload and to
avoid conflict of interest in the review.


Applications are to be submitted on the form PHS 398 (rev. 09/91)
available at most institutional offices of sponsored research and from
the Office of Grants Inquiries, Division of Research Grants, National
Institutes of Health, Westwood Building, Room 449, Bethesda, MD,
telephone (301) 710-0267.  On item 2a of the face page of the
application, applicants must enter: "RFA:  Core Grants for Clinical
Nutrition Research Units, RFA number DK-93-020."  The RFA label
available in the application form PHS 398 must be affixed to the bottom
of the face page.  Failure to use this label could result in delayed
processing of the application to the extent that it may not reach the
review committee in time for review.

Applications must be received by November 18, 1993, the original and
three copies of the application must be sent or delivered to:

Application Receipt Office
Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892**

Two additional copies of the application under separate cover must be
sent to:

Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases
Westwood Building, Room 603
Bethesda, MD  20892


Upon receipt, applications will be initially reviewed by the Division
of Research Grants (DRG) for completeness. Incomplete applications will
be returned to the applicant without further consideration.  Evaluation
of responsiveness to the program requirements and criteria stated in
this RFA is an NIDDK staff function.

Those applications that are complete and responsive will be evaluated
in national competition in accordance with the criteria stated below
and in the CNRU Guidelines for Scientific/technical merit by an
appropriate peer review group convened by the NIDDK.  It is essential
that the written application be in a form to be reviewed on its own
merit, since no site-visit is anticipated.

Applications may be subjected to triage by an NIDDK peer review group
to determine scientific merit relative to other applications received
in response to this RFA.  If the number of applications submitted is
large compared to the number of awards to be made, a preliminary
scientific peer review may be conducted and applications withdrawn from
further competition if not competitive for the award.

The initial review group will review each application using the
criteria stated below:

A.  Biomedical Research

o  The scientific excellence of the Center's research base (its
strengths, breadth, and depth) as well as the relevance and
interrelation of these separately funded projects to the central themes
of the Center and the likelihood for meaningful collaboration among
Center investigators.  The existence of a base of established,
independently sponsored biomedical research of high quality is a
prerequisite for the establishment of a Center and is the most
important component of the review.

o  The qualifications, experience, and commitment of the Center
investigators responsible for the individual research projects and
their willingness to interrelate with each other and contribute to the
overall objectives of the Center.

o  The appropriateness and relevance of the proposed cores and their
modes of operation, facilities, and potential for contribution to
ongoing research.  Renewal applications must include the use, utility,
quality control, cost effectiveness, and demonstrated progress of any
developmental research in the shared resources.

o  For new applications, the proposed management of the P/F program and
the scientific and technical merit of the P/F projects for which funds
are requested from the Center grant.  In competitive renewal
applications, emphasis is accorded to the program as a whole, including
past track record and management of the program.

B.  Enrichment

o  Efficient and effective use and/or planned use of these limited
funds, including the contribution of these activities to enhancing the
objectives of the Center.

C.  Administration

o  The scientific and administrative leadership abilities of the
proposed Center director and associate director and their commitment
and ability to devote adequate time to the effective management of the

o  The administrative organization proposed for the following:

a.  Coordination of ongoing research between the separately funded
projects and the Center, including mechanisms for internal monitoring.

b.  Establishment and maintenance of internal communication and
cooperation among the Center investigators.

c.  Mechanism for selecting and replacing professional or technical
personnel within the Center.

d.  Mechanism for reviewing and administering funds for the P/F

e.  Management capabilities, including fiscal administration,
procurement, property and personnel management, planning, and

C.  Budget

o  The appropriateness of the budgets for the proposed work to be done
in core facilities, for P/F studies, and for enrichment in relation to
the total Center program.

D.  Institutional Commitment

o  The institutional commitment to the program, including lines of
accountability for management of the Center grant and the institution's
contribution to the management capabilities of the Center.

o  The academic environment and resources in which the activities will
be conducted, including the availability of space, equipment,
facilities, and the potential for interaction with scientists from
other departments and schools within the institution.

o  The institutional commitment to new individuals responsible for
conducting essential Center functions.

o  The institutional commitment to establishing new positions
specifically to enhance the operation of the Center.

Applications determined in the initial review process to have
sufficient merit for further consideration will be given a second level
review by the National Diabetes and Digestive and Kidney Diseases
Advisory Council.


Applications will compete for available funds with all other
applications submitted in response to this RFA and recommended by peer
review.  The following will be considered in making funding decisions:

o  Quality of the proposed center as determined by peer review.
o  Availability of funds.
o  Overall balance in the CNRU program.


Applicants should request a copy of "Guidelines for Clinical Nutrition
Research Units".  These guidelines contain important additional
information of the format, content and review criteria.  These
documents and information about programmatic issues may be obtained

Van S. Hubbard, M.D., Ph.D.
Division of Digestive Diseases and Nutrition
National Institute of Diabetes and Digestive and Kidney Diseases
Westwood Building, Room 3A18B
Bethesda, MD  20892
Telephone:  (301) 594-7573
FAX:  (301) 594-7504

Inquiries regarding fiscal matters may be directed to:

Ms. Nancy Dixon
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
Westwood Building, Room 637A
Bethesda, MD  20892
Telephone:  (301) 594-7543


Letter of Intent Receipt Date:  October 8, 1993
Application Receipt Date:       November 18, 1993
Initial Review:                 March-April 1994
Second Level Review:            May-June 1994
Anticipated Date of Award:      December 1, 1994


This program is described in the Catalog of Federal Domestic Assistance
No. 93.847.  Awards are made under authorization of the Public Health
Service Act, Title IV, Part A (Public Law 78-410, as amended by Public
Law 99-158, 42 USC 241 and 285) and administered under PHS grants
policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74.  This
program is not subject to the intergovernmental review requirements of
Executive Order 12372 or Health Systems Agency review.


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