OBESITY/NUTRITION RESEARCH CENTERS

Release Date:  October 2, 2001

RFA:  RFA-DK-02-007

National Institute of Diabetes and Digestive and Kidney Diseases
 (http://www.niddk.nih.gov)

Letter of Intent Receipt Date:  June 17, 2002
Application Receipt Date:       July 17, 2002

PURPOSE

The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 
invites applications for Obesity/Nutrition Research Centers (Core Centers: P30) 
grants. The Obesity/Nutrition Research Centers (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 2010

The Public Health Service (PHS) is committed to achieving the health 
promotion and disease prevention objectives of "Healthy People 2010," a PHS-
led national activity for setting priority areas.  This Request for 
Applications (RFA), Obesity/Nutrition Research Centers, is related to one or 
more of the priority areas.  Potential applicants may obtain a copy of 
"Healthy People 2010" at http://www.health.gov/healthypeople/.

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 
mechanism.  Responsibility for the planning, direction, and execution of the 
proposed center will be solely that of the applicant.  Except as otherwise 
stated in this announcement, awards will be administered under the NIH Grants 
Policy Statement.

Applicants from institutions which 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.  In 
such a case, 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 announcement.  
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 $750,000 in direct costs per year and $1,000,000 total costs per 
year.  Future budget period escalations may not exceed a three percent 
increase over the previous budget period.  The earliest anticipated award 
date is April 2003.

FUNDS AVAILABLE

For FY 2003, approximately $1,900,000 (total costs) has been set-aside for 
grants awarded under this RFA.  NIDDK anticipates awarding two ONRC Grants in 
Fiscal Year 2003 on a competitive basis.  However, this funding level is 
dependent upon the receipt of a sufficient number of applications of high 
scientific merit. Two existing Centers are expected to submit competing 
renewal applications.  To help meet the goals of NIDDK for managing the costs 
of biomedical research, first-time applicants must limit their requests to 
not more than $750,000 direct costs for the initial budget period. Competing 
applicants must limit their requests to not more than a 10% increase over 
their last year’s awarded budget, or $750,000, whichever is less.  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.  
A Core Center must be an identifiable unit within a single university medical 
center or a consortium of cooperating institutions, including an affiliated 
university.  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 this is 
already funded at the time of submission of a Center grant application.  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.  Four 
to 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 biostatistics, imaging, biotechnology, and 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.

SPECIAL REQUIREMENTS

At least 50 percent of the already funded research base in a new application 
must be supported by the NIDDK.  In competing continuation applications the 
percent may be less than 50 percent due to, for example, a growing research 
base of investigators entering digestive diseases from other fields.  The 
initial review group will determine the significance of the research base.

Center Principal Investigators are required, and their administrators 
encouraged, to attend a once a year meeting to be held at a location to be 
determined by the NIDDK.  Funds for travel to this meeting should be included 
in the budget for the Administrative Core of the Center.

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 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 
UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in 
Clinical Research," published in the NIH Guide for Grants and Contract on 
August 2, 2000 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html); 
a complete copy of the updated Guidelines is available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm.  The 
revisions relate tot NIH defined Phase III clinical trials and require: a) 
all applications or proposals and/or protocols to provide a description of 
plans to conduct analyses, as appropriate, to address differences by 
sex/gender and /or racial/ethnic groups, including subgroups if applicable; 
and b) all investigators to report accrual, and to conduct and report 
analyses, as appropriate, by sex/gender and/or racial/ethnic group 
differences.

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 are scientific and 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:  http://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.

REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS

All investigators proposing research involving human subjects should read the 
policy that was published in the NIH Guide for Grants an Contracts, June 5, 
2000 (Revised August 25, 2000), and is available at the following URL address 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

URLS in NIH GRANT APPLICATIONS OR APPENDICES

All applications and proposals for NIH funding must be self-contained within 
specified page limitations.  Unless otherwise specified in an NIH 
solicitation, Internet addresses (URLs) should not be used to provide 
information necessary to the review because reviewers are under no obligation 
to view the Internet sites.  Reviewers are cautioned that their anonymity may 
be compromised when they directly access an Internet site.

PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT

The Office of Management and Budget (OMB) Circular A-110 has been revised to 
provide public access to research data through the Freedom of Information Act 
(FOIA) under some circumstances.  Data that are (1) first produced in a 
project that is supported in whole or in part with Federal funds and (2) 
cited publicly and officially by a Federal agency in support of an action 
that has the force and effect of law (i.e., a regulation) may be accessed 
through FOIA.  It is important for applicants to understand the basic scope 
of this amendment.  NIH has provided guidance at:
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.

Applicants may wish to place data collected under this RFA in a public 
archive, which can provide protections for the data and manage the 
distribution for an indefinite period of time.  If so, the application should 
include a description of the archiving plan in the study design and include 
information about this in the budget justification section of the 
application. In addition, applicants should think about how to structure 
informed consent statements and other human subjects procedures given the 
potential for wider use of data collected under this award.

LETTER OF INTENT

Prospective applicants are asked to submit, by June 17, 2002, 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 
plan the review.

The letter of intent is to be sent to:

Francisco O. Calvo, Ph.D.
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Blvd., Room 752, MSC 5452
Bethesda MD  20892-5452 (Courier use Zip 20817)
Telephone:  (301) 594-8897
FAX:  (301) 480-3505
Email:  fc15y@nih.gov

APPLICATION PROCEDURES

The PHS 398 research grant application instructions and forms (rev. 5/2001) 
at http://grants.nih.gov/grants/funding/phs398/phs398.html are to be used in 
applying for these grants. This version of the PHS 398 is available in an 
interactive, searchable PDF format.  For further assistance contact 
GrantsInfo, Telephone 301/435-0714, Email: GrantsInfo@nih.gov.

It is strongly recommended that applicants contact the NIDDK program staff 
listed under INQUIRIES below to obtain a copy of the current Administrative 
Guidelines for Obesity/Nutrition Research Centers.
 
The RFA label available in the PHS 398 (rev. 5/2001) application form must be 
affixed to the bottom of the face page of the application.  Type the RFA 
number on the label.  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. The RFA label is also available at: 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.

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
6707 Democracy Blvd.,  Room 752, MSC 5452
Bethesda MD  20892-5452 (Courier use Zip 20817)

Applications must be received by July 17, 2002.  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 applications or non-responsive 
applications will be returned to the applicant without further consideration.  

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.

REVIEW CRITERIA

The initial review group will review each application using the criteria 
stated below and 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, 
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.

Schedule

Letter of Intent Receipt Date:    June 17, 2002
Application Receipt Date:         July 17, 2002
Peer Review Date:                 September/October 2002
Council Review:                   January 2003
Earliest Anticipated Start Date:  April 2003

AWARD CRITERIA

The earliest anticipated date of award is April 2003.  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, availability of funds, and geographic 
distribution.

INQUIRIES

Inquiries concerning this RFA are encouraged. The opportunity to clarify any 
issues or questions from potential applicants is welcomed.  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.
Chief, Nutritional Sciences Branch
Division of Digestive Diseases and Nutrition
National Institutes of Diabetes and Digestive and Kidney Diseases
National Institutes of Health
6707 Democracy Boulevard, Room 679, MSC 5450
Bethesda, MD  20892-5450
Phone:  (301) 594-8883
Fax:  (301) 480-8300
E-mail:  vh16h@nih.gov

Direct inquires regarding review issues to:

Francisco O. Calvo, Ph.D.
Chief, Review Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 752, MSC 5452
Bethesda MD  20892-5452 (Courier use Zip 20817)
Telephone:  (301) 594-8897
FAX:  (301) 480-3505
Email:  fc15y@nih.gov

Direct inquiries regarding fiscal matters to:

Ms. Sharon T. Bourque
Grants Management Specialist
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases, NIDDK
6707 Democracy Boulevard, Room 719, MSC 5456
Bethesda, MD  20892-5456
Phone:  (301) 594-8846
Fax:  (301) 480-3504
E-mail:  sb114m@nih.gov

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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