Full Text DK-96-011
NIH GUIDE, Volume 25, Number 18, June 7, 1996
RFA:  DK-96-011
P.T. 04

  Biomedical Research, Multidiscipl 

National Institute of Diabetes and Digestive and Kidney Diseases
Letter of Intent Receipt Date:  September 26, 1996
Application Receipt Date:  October 29, 1996
The National Institute of Diabetes and Digestive and Kidney Diseases
(NIDDK) invites applications for Obesity/Nutrition Research Centers
(Core Centers P30) for conducting basic and clinical research on
obesity and the related fields of energy metabolism, body
composition, satiety, adipocyte metabolism, eating disorders, and
weight management.  The centers will be awarded in Fiscal Year 1997.
The award of at least two Obesity/Nutrition Research Centers by NIDDK
is anticipated.  Two existing Centers are expected to submit
competitive renewal applications.
The Public Health Service (PHS) is committed to achieving the health
promotion and disease prevention goals of "Healthy People 2000," a
PHS-led 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 202-512-1800).
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
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
and predominantly from the NIH or other Federal agencies.
Racial/ethnic minority individuals, women, and persons with
disabilities are encouraged to apply as Principal Investigators.
Foreign institutions are not eligible to apply.
Support of this program will be through the NIH core center grant
(P30) award.  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.
Applicants from institutions that have a General Clinical Research
Center (GCRC) funded by the 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.
This RFA is a one-time solicitation.  The receipt of two competing
continuation application is anticipated, which will be in competition
with other applications received in response to this RFA.  The total
requested project for an application submitted in response to this
RFA may not exceed five years.  Requests for support must be limited
to no more than $700,000 in direct costs per year and $1,000,000
total costs per year.  The anticipated award date is September 30,
For FY 1997, up to $1,434,000 total costs will be committed to fund
applications submitted in response to this RFA.  It is anticipated
that two awards will be made; however, this funding level is
dependent upon the receipt of a sufficient number of applications of
high scientific merit.  Although this program is provided for in the
financial plans of the NIDDK, the award of grants pursuant to this
RFA is also contingent upon the availability of funds for this
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.  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 and
the organization of the application.
The Obesity/Nutrition Research Centers are based on the core concept.
Five or six cores are usually included in a Center.  Cores are
defined as shared resources that enhance productivity or in other
ways benefit a group of investigators working in obesity and
nutritional sciences research to accomplish the stated goals of the
Center. Examples of such resources include cell culture and
radioimmunoassay instrumentation facilities.
Centers are encouraged to include a clinical component or core that
deals with patients.  This clinical component can exist as a
stand-alone core or part of another core such as the administrative
core.  Besides leading to a better understanding of disease etiology
and natural history of disease, such cores might provide
biostatistics support, enhance clinical study design, enhance
collaboration among researchers and recruitment of subjects for
clinical studies, provide for epidemiological studies, or provide
modest funding for tissue, DNA, or serum storage.  In addition, a
clinical or epidemiology core may more effectively address NIH
policies concerning issues of women and ethnic minority participation
in clinical studies.
Two other types of activities may also be supported with Center
funding:  a pilot and feasibility (P/F) program and an enrichment
program.  The P/F program provides modest support for new initiatives
or feasibility research studies.  This program is directed at new
investigators, at investigators established in other research
disciplines with expertise that may be applied to obesity and
nutritional sciences research, and, occasionally, at investigators
who wish to make a substantial change in the direction of their
research. In addition, temporary salary support for one Named New
Investigator in a specified area of research with a defined P/F study
may be requested for up to 24 months, with subsequent individuals to
be named by the Center Director and approved by the Center's External
Advisory Board and the NIDDK.  The Core Center grant may include
limited funds for program enrichment such as seminars, visiting
scientists, consultants, and workshops.
It is the policy of the NIH that women and members of minority groups
and their sub-populations 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 28, 1994 (FR 59 14508-14513), and reprinted
in the NIH GUIDE FOR GRANTS AND CONTRACTS Volume 23, Number 11, March
18, 1994.
Investigators may also obtain copies from these sources or from the
program staff or contact person listed under INQUIRIES.  Program
staff may also provide additional relevant information concerning the
Prospective applicants are asked to submit, by September 26, 1996, a
letter of intent that includes a descriptive title of the proposed
research, the name, address, and telephone number of the Principal
Investigator, the identities of other key personnel and participating
institutions, 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 a subsequent application, the
information that it contains allows NIDDK staff to estimate the
potential review workload and avoid conflict of interest in the
The letter of intent is to be sent to:
Chief, Review Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
45 Center Drive, Room 6AS 37-E - MSC -6600
Bethesda, MD  20892-6600
Telephone:  (301) 594-8885
FAX:  (301) 480-3505
The research grant application form PHS 398 (5/95) is to be used in
applying for these grants.  Applications kits are available at most
institutional offices of sponsored research and may be obtained from
the Grants Information Office, Office of Extramural Outreach and
Information Resources, National Institutes of Health, 6701 Rockledge
Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267,
email:  ASKNIH@odrockm1.od.nih.gov.
Additional information about Obesity/Nutrition Research Centers and
suggestions that could be helpful to the applicant are given in
"Administrative Guidelines for Obesity/Nutrition Research Centers"
which may be requested from the NIDDK program staff listed under
The RFA label available in the PHS 398 (rev. 5/95) application form
must be affixed to the bottom of the face page of the application.
Failure to use this label could result in delayed processing of the
application such that it may not reach the review committee in time
for review.  In addition, the RFA title and number must be typed on
line 2 of the face page of the application form and the YES box must
be marked.
Submit a signed, typewritten original of the application, including
the Checklist, plus three signed photocopies, in one package to:
6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710
BETHESDA, MD 20892-7710
BETHESDA, MD 20817 (for express/courier service)
At time of submission, two additional copies of the application must
be sent  to:
Chief, Review Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
45 Center Drive, Room 6AS 37-E - MSC 6600
Bethesda, MD  20892-6600
Applications must be received by October 29, 1996.  If an application
is received after that date, it will be returned to the applicant
without review.  The Division of Research Grants (DRG) will not
accept any application in response to this RFA that is essentially
the same as one currently pending initial review, unless the
applicant withdraws the pending application.  The DRG will not accept
any application that is essentially the same as one already reviewed.
This does not preclude the submission of substantial revisions of
applications previously reviewed, but such applications must include
an introduction addressing the previous critique.
Upon receipt, applications will be initially reviewed for
completeness and responsiveness.  Incomplete applications or
non-responsive applications will be returned to the applicant without
further consideration.  Evaluation for responsiveness to the program
requirements and criteria stated in the RFA is an NIDDK staff
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 NIH peer review
procedures.  Applications are unlikely to be reviewed by a site visit
team; therefore, the written application must be complete to
facilitate review without a site visit.  As part of the initial merit
review, all applications will receive a written critique and undergo
a process in which only those applications deemed to have the highest
scientific merit will be discussed, assigned a priority score, and
receive a second level review by the National Diabetes and Digestive
and Kidney Advisory Council.
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 (such as how usage will be prioritized),
facilities, and potential for contribution to ongoing research.
Renewal applications must document the use, utility, quality control
and cost effectiveness of each Core requested to continue as part of
the Center.  Progress will be judged in part on the list of
publications arising from the cores.  At least two users are required
to establish a core.  However, a greater number of users generally
can be evaluated as more cost effective.
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 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.
The anticipated date of award is September 30, 1997. Applications
will compete for available funds with all other applications
submitted in response to this RFA and recommended for further
consideration 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 Obesity/Nutrition Research Centers program.
Letter of Intent Receipt Date:  September 26, 1996
Application Receipt Date:       October 29, 1996
Initial Review:                 March-April 1997
Second Level Review:            May-June 1997
Anticipated Date of Award:      September 1997
Prospective applicants should request the pamphlet "Administrative
Guidelines for Obesity/Nutrition Research Centers" from the program
office listed below.  Inquiries concerning this RFA are encouraged.
The opportunity to clarify any issues or questions from potential
applicants is welcome.
Direct requests for the Administrative Guidelines and inquiries
regarding programmatic issues to:
Van S. Hubbard, M.D., Ph.D.
Division of Digestive Diseases and Nutrition
National Institute of Diabetes and Digestive and Kidney Diseases
45 Center Drive, MSC 6600
Bethesda, MD  20892-6600
Telephone:  (301) 594-8883
FAX: (301) 480-8300
Email:  hubbardv@ep.niddk.nih.gov
Direct inquiries regarding fiscal and administrative matters to:
Mrs. Sharon Bourque
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
45 Center Drive, Room 6AS-49H - MSC 6600
Bethesda, MD  20892-6600
Telephone:  (301) 594-8846
FAX:  (301) 480-3504
Email:  bourques@ep.niddk.nih.gov
This program is described in the Catalog of Federal Domestic
Assistance No. 93.848.  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 PHS strongly encourages all grant and contract recipients to
provide a smoke-free workplace and promote the non-use of all tobacco
products.  In addition, Public Law 103-227, the Pro-Children Act of
1994, prohibits smoking in certain facilities (or in some cases, any
portion of a facility) in which regular or routine education,
library, day care, health care or early childhood development
services are provided to children. This is consistent with the PHS
mission to protect and advance the physical and mental health of the
American people.

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