Full Text DK-94-019


NIH GUIDE, Volume 23, Number 25, July 1, 1994

RFA:  DK-94-019

P.T. 34

  Biomedical Research, Multidiscipl 

National Institute of Diabetes and Digestive and Kidney Diseases

Letter of Intent Receipt Date:  October 21, 1994
Application Receipt Date:  November 22, 1994


The National Institute of Diabetes and Digestive and Kidney Diseases
(NIDDK) invites applications for funding of two Clinical Nutrition
Research Unit (CNRU) grants to be competitively awarded in Fiscal
Year 1996.


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


Support of this program will be through the National Institutes of
Health (NIH) core center grant (P30).  Responsibility for the
planning, direction, and execution of the proposed project will be
solely that of the applicant.  Awards will be administered under PHS
grants policy as stated in the PHS Grants Policy Statement.  The
receipt of two competing continuation applications is anticipated,
which will be in competition with other applications received in
response to this RFA.  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 $775,000 total costs for the first budget period.


Approximately $1,550,000 (total costs) has been set-aside for grants
awarded under this RFA.  The NIDDK anticipates awarding two CNRU
Grants in Fiscal Year 1996 on a competitive basis.


The NIDDK-supported Clinical Nutrition Research Units (CNRUs) are
part of an integrated program of nutrition and obesity-research
support provided by the 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 NIH research
project grants (R01), FIRST Awards (R29), Program Projects (P01),
Individual Fellowships (F32), and Institutional National Research
Service Awards (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, and allied health personnel (funds to be derived from
other sources*);

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 RFA.

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 may
consult with NIDDK staff concerning plans for the development of the

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 application.



It is the policy of the NIH that women and members of minority groups
and their subpopulations must be included in all NIH supported
biomedical and behavioral research projects involving human subjects,
unless a clear and compelling rationale and justification is provided
that inclusion is inappropriate with respect to the health of the
subjects or the purpose of the research.  This new policy results
from the NIH Revitalization Act of 1993 (Section 492B of Public Law
103-43) and supersedes and strengthens the previous policies
(Concerning the Inclusion of Women in Study Populations, and
Concerning the Inclusion of Minorities in Study Populations), which
have been in effect since 1990. The new policy contains some
provisions that are substantially different from the 1990 policies.

All investigators proposing research involving human subjects should
read the "NIH Guidelines For Inclusion of Women and Minorities as
Subjects in Clinical Research," which have been published in the
Federal Register of March 9, 1994 (FR 59 11146-11151) and reprinted
in the NIH Guide for Grants and Contracts, Volume 23, Number 11,
March 18, 1994.

Investigators also may obtain copies of the policy from the program
staff listed under INQUIRIES.  Program staff may also provide
additional relevant information concerning the policy.


Potential applicants are strongly encouraged to submit a letter of
intent no later than October 21, 1994.  The letter of intent is to
include the names of the Principal Investigator/program director and
principal collaborators, a descriptive title of the potential
application, identification of the organization(s) involved, and
reference to the RFA number "DK-94-019."

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.

The letter of intent is to be sent to:

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


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 Information, 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-94-019."  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 22, 1994, the original and
three copies of the application must be sent or delivered to:

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.  Evaluation of
responsiveness to the program requirements and criteria stated in
this RFA is an NIDDK staff function.  Incomplete or non-responsive
applications will be returned to the applicant without further

Applications that are complete and responsive to the RFA will be
evaluated for scientific and technical merit by an appropriate peer
review group convened by the NIDDK in accordance with the review
criteria stated below and in the CNRU Guidelines.  As part of the
initial merit review, a process (triage) may be used by the initial
review group in which applications will be determined to be
competitive or non-competitive based on their scientific merit
relative to other applications received in response to the RFA.
Applications judged to be competitive will be discussed and be
assigned a priority score.  Applications determined to be non-
competitive will be withdrawn from further consideration and the
Principal Investigator and the official signing for the applicant
organization will be notified.  It is essential that the written
application be in a form to be reviewed on its own merit, since no
site-visit is anticipated.

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
pilot/feasibility (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 program.

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

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

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

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 from:

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. Trude McCain
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
Westwood Building, Room 653
Bethesda, MD  20892
Telephone:  (301) 594-7543


Letter of Intent Receipt Date:  October 21, 1994
Application Receipt Date:       November 22, 1994
Initial Review:                 March-April 1995
Second Level Review:            May-June 1995
Anticipated Date of Award:      December 1, 1995


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

The Public Health Service strongly encourages all grant recipients to
provide a smoke-free workplace and promote the non-use of all tobacco
products.  This is consistent with the PHS mission to protect and
advance the physical and mental health of the American people.


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