OBESITY/NUTRITION RESEARCH CENTERS

Release Date:  July 19, 1999

RFA:  DK-99-016

National Institute of Diabetes and Digestive and Kidney Diseases

Letter of Intent Receipt Date:  October 19, 1999
Application Receipt Date:  November 19, 1999

PURPOSE

The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
invites applications for two Obesity/Nutrition Research Center (Core Centers:
P30) grants to be competitively awarded.  One award will be made in Fiscal
Year 2000 (September 2000) and one award will be made early in Fiscal year
2001.  Two existing Centers are expected to submit competitive renewal
applications.  The Obesity/Nutrition Research Center (ONRC) grants provide a
focus for increasing collaboration and improving the cost-effectiveness of
supported research among groups of successful investigators at institutions
with an established, comprehensive federally supported research base involving
both basic and clinical research related to obesity.

HEALTHY PEOPLE 2000

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" at http://www.crisny.org/health/us/health7.html

ELIGIBILITY REQUIREMENTS

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.

MECHANISM OF SUPPORT

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 applications are anticipated, which will be in competition
together with other applications received in response to this RFA.  The total
requested project period for applications 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 earliest anticipated award date is September 2000.

FUNDS AVAILABLE

Approximately $1,900,000 (total costs) has been set-aside for grants awarded
under this RFA.  NIDDK anticipates awarding one ONRC Grant in Fiscal Year 2000
(September 2000), and one in Fiscal Year 2001 (December 2000), on a
competitive basis; however, this funding level is dependent upon the receipt
of a sufficient number of applications of high scientific merit.  To help meet
the goals of NIDDK for managing the costs of biomedical research, applicants
must limit their requests to not more that $700,000 direct costs for the
initial budget period.  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 purpose.

RESEARCH OBJECTIVES

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), 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 ONRCs 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, or 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 children, 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.

STUDY POPULATIONS

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

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).

All investigators proposing research involving human subjects should read the
"NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical
Research," which was published in the Federal Register of March 28, 1994 (FR
59 14508-14513) and in the NIH Guide For Grants and Contracts, Vol. 23, No.
11, March 18, 1994, available on the web at:
https://grants.nih.gov/grants/guide/1994/94.03.18/notice-nih-guideline008.html

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of NIH that children (i.e., individuals under the age of 21)
must be included in all human subjects research, conducted or supported by the
NIH, unless there is scientific or ethical reasons not to include them.  This
applies to all initial (Type 1) applications submitted for receipt dates after
October 1, 1998.

All investigators proposing research involving human subjects should read the
"NIH Policy and Guidelines on the inclusion of Children as Participants in
Research Involving Human Subjects" that was published in the NIH Guide for
Grants and Contracts, March 6, 1998, and is available at the following URL
address: https://grants.nih.gov/grants/guide/notice-files/not98-024.html

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

LETTER OF INTENT

Prospective applicants are asked to submit, by October 19, 1999, 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 review.

The letter of intent is to be sent to:

Chief, Review Branch
NIDDK, Division of Extramural Activities
Natcher Building, Room 6AS-37F
45 CENTER DR MSC -6600
BETHESDA MD 20892-6600
Telephone:  (301) 594-8886
FAX:  (301) 480-3505

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev. 4/98) is to be used in
applying for these grants.  These forms are available at most institutional
offices of sponsored research and may be obtained from the Division of
Extramural Outreach and Information Resources, National Institutes of Health,
6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone
301-710-0267, email: GrantsInfo@nih.gov.

Administrative Guidelines for Obesity/Nutrition Research Centers may be
requested from the NIDDK program staff listed under INQUIRIES below.

The RFA label available in the PHS 398 (rev. 4/98) 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 your 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.

The RFA label and line 2 of the application should both indicate the RFA
number.  The RFA label must be affixed to the bottom of the face page. 
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.

The sample RFA label available at: 
https://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to
allow for this change.  Please note this is in pdf format.

Submit a signed, typewritten original of the application, including the
Checklist, plus three signed photocopies, in one package to:

CENTER FOR SCIENTIFIC REVIEW
NATIONAL INSTITUTES OF HEALTH
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
Natcher Building, Room 6AS-37F
45 CENTER DR MSC 6600
BETHESDA MD 20892-6600

Applications must be received by November 19, 1999.  If an application is
received after that date, it will be returned to the applicant without review. 
Supplemental documents containing significant revision or additions will not
be accepted, unless applicants are notified by the Scientific Review
Administrator.  The Center for Scientific Review (CSR) 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 CSR 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.

REVIEW CONSIDERATIONS

Upon receipt, applications will be initially reviewed for completeness by CSR
and responsiveness by NIDDK.  Incomplete and/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 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.  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, generally the top half of the applications under review,
will be discussed, assigned a priority score, and receive a second level
review by the National Diabetes and Digestive and Kidney Diseases Advisory
Council.

The initial review group will review each application using the criteria
stated below and in the OBESITY/NUTRITION RESEARCH CENTERS ADMINISTRATIVE
GUIDELINES.  The most important component of an ONRC is an ongoing, strong
base of obesity and nutritional science related research.

Specific review criteria for ONRC Core Centers are:

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  The scientific excellence of the Center's research base (its strengths, its
breadth and depth) as well as the relevance and interrelation of these
separately funded research projects to the central theme(s) or focus of the
Center and the likelihood for meaningful collaborations among Center
investigators.  The existence of a base of established, independently
supported biomedical research of high quality is a prerequisite for the
establishment of a CNRU Core Center and is the most important component of the
review. (The results of previous peer reviews of its content will weigh
heavily in the assessment of the application's overall strength as a potential
recipient of an award.)

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
ONRC Core 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.  Competing continuation 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 by the list of publications arising from the cores.  At least
two users are required to establish a core (Pilot and Feasibility projects do
not count as a user for this purpose.)  However, a greater number of users
will be considered to be more cost effective.

o  For all applications, a description of current or proposed P/F studies
should be submitted for evaluation as part of the review of the P/F program.
In general for new applications, the proposed P/F projects will be examined to
assess the eligibility of the P/F applicant and the adequacy of the selection
process by which the individual studies were selected.  For competitive
renewal applications emphasis is accorded to the program as a whole, including
past track record and management of the program. Applicants should refer to
the Administrative Guidelines for ONRCs for specific details regarding the P/F
program and its review.

o  A Named New Investigator, if requested, will be considered separately.

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 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 Core Center;

(d) Mechanism for reviewing the use of and administering funds for the P/F
program;

(e) Management capabilities that include fiscal administration, procurement,
property and personnel management, planning, budgeting, and other appropriate
capabilities;

o  The institutional commitment to the program, including lines of
accountability regarding 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
institutions;

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

o  The appropriateness of the budgets for the proposed and approved work to be
done in Core facilities, for P/F studies (these are restricted funds) and for
enrichment in relation to the total Center program.

Also, for competing continuation applications, the budget reductions
instituted in accordance with NIDDK administrative policy are taken into
consideration.  Ongoing Center grants have incurred negotiated budget
reductions averaging approximately 10 to 20 percent per year in addition to
the budget reductions recommended by the Initial Review Group as indicated in
the summary statements.  The applicant should address how these cuts affected
their Center.

AWARD CRITERIA

The earliest anticipated date of award is September 2000 for one ONRC and
December 2000 for one ONRC.  Applications recommended by the National Diabetes
and Digestive and Kidney Diseases Advisory Council will be considered for
funding on the basis of overall scientific and technical merit of the research
as determined by peer review, program needs and balance, and availability of
funds.

INQUIRIES

Inquiries concerning this RFA are encouraged. The opportunity to clarify any
issues or questions from potential applicants is welcome.  It is strongly
suggested that the pamphlet "Administrative Guidelines for Clinical Nutrition
Research Unit Core Centers" be obtained before an application is prepared.

Inquiries regarding programmatic issues and requests for the Administrative
Guidelines may be directed to:

Van S. Hubbard, M.D., Ph.D.
Division of Digestive Diseases and Nutrition
National Institute of Diabetes and Digestive and Kidney Diseases
Natcher Building, Room 6AN-18F
45 CENTER DR MSC 6600
BETHESDA, MD  20892-6600
Telephone:  (301) 594-8883
FAX:  (301) 480-8300
Email: hubbardv@extra.niddk.nih.gov

Direct inquiries regarding fiscal matters to:

Mrs. Sharon Bourque
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
Natcher Building, Room 6AN-49H
45 CENTER DR MSC 6600
BETHESDA, MD  20892-6600
Telephone:  (301) 594-8846
FAX:  (301) 480-3504
Email: bourques@extra.niddk.nih.gov

Schedule

Letter of Intent Receipt Date:  October 19, 1999
Application Receipt Date:       November 19, 1999
Initial Review:                 March/April 2000
Second Level Review:            May 2000
Anticipated Date of Award:      September 2000 and December 2000

AUTHORITY AND REGULATIONS

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 review.

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 routing 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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