CLINICAL NUTRITION RESEARCH UNIT CORE CENTERS

Release Date:  May 1, 1998

RFA:  DK-98-013

P.T.

National Institute of Diabetes and Digestive and Kidney Diseases

Letter of Intent Receipt Date:  September 23, 1998
Application Receipt Date:  November 10, 1998

PURPOSE

The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
invites applications for funding of eight Clinical Nutrition Research Unit (CNRU)
grants to be competitively awarded (three in September 1999 (FY 1999), four in
FY 2000, and one in FY 2001).  Six existing CNRUs are expected to submit
competitive renewal applications.  The Clinical Nutrition Research Units grants
are core centers (P30) that 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 nutritional sciences and obesity-related research base.

HEALTHY PEOPLE 2000

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),
Clinical Nutrition Research Unit Core 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).

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 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 such as research
project grants (R01), program project grants (P01), Mentored Clinical Scientist
Development Awards (K08), cooperative agreements, and contracts, or through other
Federal Agencies or non-federal groups.  It is required that at least fifty
percent of the nutritional sciences and obesity-related research comprising the
research base be supported by Federal Agencies.  Minority individuals and women
are encouraged to submit 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. The receipt of six
competing continuation applications is anticipated.  These applications will be
in competition together 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 $800,000 total costs for the first budget period.  Future
budget period escalations may not exceed a 3 percent increase over the previous
budget period.

FUNDS AVAILABLE

Approximately $6,525,000 (total costs) has been set-aside for grants awarded
under this RFA.  NIDDK anticipates awarding three CNRU Grants in FY 1999, four
in FY 2000 and one in FY 2001, on a competitive basis.  However, this funding
level is dependent upon the receipt of a sufficient number of applications of
high scientific merit.  Applicants must limit their requests to not more than
$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 NIDDK-supported CNRUs are part of an integrated program of nutrition and
obesity-research support provided by NIDDK.  These centers have provided a focus
for increasing collaboration and cost effectiveness among groups of successful
investigators at institutions with established comprehensive federally supported
nutritional sciences and obesity research base.

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 should consult with NIDDK staff
concerning plans for the development of the center.

A CNRU should be comprised the following components and include other sources of
support such as an NIH research project grant (R01), NIH Program Project (P01),
NIH Individual Fellowship (F32), and the NIH Institutional National Research
Service Award (T32) or other Federal and non-federal sources:

Required Components

1.  Research with human subjects and populations;

2.  Basic laboratory investigations;

3.  Research training (funds to be derived from other sources*);

4.  Shared facilities and research services;

Encouraged Components (The presence of these components demonstrate the
institutional commitment and the recognition of the clinical nutritional sciences
and obesity within the Institution(s)).

5.  Education programs emphasizing the nutritional sciences and obesity and
related conditions or disorders 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 sources*).

*  Funds to support these components may not be requested as part of an
application in response to this announcement.

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.  It is appropriate and may be beneficial to have one
or more central themes around which core center research investigations are
focused.  A clinical component or core that deals with patients is often helpful. 
This clinical component can exist as a stand-alone core or as a 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; foster collaboration among
researchers; aid in recruitment of subjects for clinical studies; support
epidemiological studies in areas of nutritional sciences and obesity; or provide
modest funding for tissue, DNA, or serum storage.  In addition, a clinical or
epidemiology core may more effectively address NIH policies concerning the
participation of women, children, and ethnic minority populations 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 and at investigators established in other
research disciplines with expertise that may be applied to nutritional sciences
and obesity 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.  Subsequent individuals for this slot will be
named by the Center Director and approved by the Centerþs 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.

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
"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 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.

NIH POLICY AND GUIDELINES ON THE 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:
http://grants.nih.gov/grants/guide/notice-files/not98-024.html

LETTER OF INTENT

Prospective applicants are asked to submit, by September 23, 1998, 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
this RFA.  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 to
avoid conflicts of interest in the review.

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-37F, MSC 6600
Bethesda, MD  20892-6600
Telephone:  (301) 594-8886
FAX:  (301) 480-3505 

APPLICATION PROCEDURES

The research grant applications form PHS 398 (rev. 5/95) 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, Phone (301) 435-0714, FAX: (301) 480-
0525, Email: asknih@od.nih.gov.  Forms are also available on the NIH Website at
http://grants.nih.gov/grants/forms.htm 

Administrative Guidelines for Clinical Nutrition Research Unit Core Centers may
be requested from the NIDDK program staff listed under INQUIRIES below.

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:

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 also be sent
to:

Chief, Review Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
45 Center Drive, Room 6AS-37F, MSC 6600
Bethesda, MD  20892-6600

Applications must be received by November 10, 1998.  If an application is
received after that date, it will be returned to the applicant without review. 
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 the CSR
and responsiveness by the NIDDK.  Incomplete and/or non-responsive applications
will be returned to the applicant without further consideration.  Applications
that are complete and are 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 Diseases Advisory Council.

The most important component of a CNRU is an ongoing, strong base of nutritional
sciences and obesity-related research.

Specific review criteria for CNRU 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 CNRU
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 CNRUs 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.  

As part of the scientific and technical merit evaluation of the research plan,
reviews will be instructed to address adequacy of plans to include both genders,
minorities and their subgroups, and children as appropriate for the scientific
goals of the research, or justification for exclusion.

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 1999 for three centers,
December 1999 for four centers and December 2000 for one center.

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
45 Center Drive, Room 6AN-18F - 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
45 Center Drive, Room 6AN-49H - 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:       September 23, 1998
Application Receipt Date:            November 10, 1998
Initial Review:                      March/April 1999
Second Level Review:                 May 1999
Anticipated FY 1999 Dates of Award:  September 1999

Award dates for FY 2000 and FY 2001 may be obtained by contacting program staff
listed above.

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
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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