Full Text DK-94-020


NIH GUIDE, Volume 23, Number 19, May 20, 1994

RFA:  DK-94-020

P.T. 04

  Biomedical Research, Multidiscipl 
  Biology, Cellular 

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 Obesity/Nutrition Research Centers
(ONRC) to conduct basic and clinical research on obesity and the
related fields of energy metabolism, body composition, satiety,
adipocyte metabolism, eating disorders, and weight management.  This
center will be awarded as a core center in Fiscal Year 1996.  The
award of at least one ONRC by NIDDK is anticipated.


The Public Health Service (PHS) is committed to achieving the health
promotion and disease prevention goals of "Healthy People 2000," a
PHS-lead national activity for setting priorities.  This Request for
Applications (RFA), Obesity/Nutrition Research Centers, 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 Summary Report:
Stock No 017-001-00473-1) through the Superintendent of Documents,
Government Printing Office, Washington, DC 20402-9325 (telephone


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
nutritional sciences, obesity, eating disorders, energy regulation
and the nutritional sciences.  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.  Awards
will be administered under PHS grants policy as stated in the PHS
Grants Policy Statement.  The receipt of one competing continuation
application is anticipated, which will be in competition with other
applications received in response to this RFA.  The anticipated award
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
the award will average approximately $1,000,000 total costs for the
first budget period.


Approximately $1,000,000 (total costs) has been set-aside for one
grant awarded under this RFA.  The NIDDK anticipates awarding this
ONRC in FY 1996.


The objectives of the Core Center are to encourage a
multidisciplinary approach to research in the nutritional sciences
and to bring together, on a cooperative basis, clinical and basic
science investigators in a manner that will enhance and extend the
effectiveness of nutritional research being conducted in the field of
obesity, eating disorders, and energy regulation.  To accomplish the
overall goal of these centers, there must be in existence at the
applicant's institution an ongoing program of excellence in
biomedical research related to the study of obesity.  This research
should be in the form of NIH-funded research projects (R01), FIRST
Awards (R29), program projects (P01) or other peer-reviewed research
from Federal and non-federal sources.  The research base in the
nutritional sciences need not be exclusively in obesity and can
include a focus on eating disorders, energy metabolism, cell biology,
or nutrient metabolism.  It would be highly desirable that the
Principal Investigator, as well as the applicant institution, have a
commitment to the treatment and prevention of obesity.  The
availability of a clinic population with adequate representation of
women and minorities that can be readily utilized by investigators
will play a major role in attracting investigators to the field of
obesity research and to serve as a resource in the design of pilot
and feasibility projects.

The Core Center grant mechanism builds upon an established research
base that emphasizes common themes or areas of interest.  The Core
Center grant may provide funds for: (1) research cores such as units
for body composition analyses, energy expenditure, cell culture, cell
and molecular biology, clinical studies or nutrient analyses.  These
cores must be utilized by already funded projects of two or more
center participants; (2) pilot/feasibility projects that encourage
new investigators or established investigators from other fields to
pursue new innovative ideas to a point where they can compete for
independent support; (3) temporary salary support to one new named
investigator, usually for 24 months, in specified areas of research
complementary to ongoing activities of the group and with an approved
pilot/feasibility project; (4) program enrichment funds to provide
for small conferences or symposia, advisory committee expenses and
special consultants.

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 must 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, by October
21, 1994, a letter of intent that includes 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 the number and title of the RFA in
response to which the application may be submitted.

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
Obesity/Nutrition Research Units, RFA number DK-94-020."  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 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.  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.

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 Obesity/Nutrition Research Centers
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 Obesity/Nutrition Research Centers program.


Applicants should request a copy of "Guidelines for Obesity/Nutrition
Research Centers".  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. 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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