Full Text DK-96-008

DIABETES ENDOCRINOLOGY RESEARCH CENTERS

NIH GUIDE, Volume 24, Number 39, November 3, 1995

RFA:  DK-96-008

P.T. 04

Keywords: 
  Diabetes 
  Endocrinology 


National Institute of Diabetes and Digestive and Kidney Diseases

Letter of Intent Receipt Date:  January 25, 1996
Application Receipt Date:  March 14, 1996

PURPOSE

The National Institute of Diabetes and Digestive and Kidney Diseases
(NIDDK) supports six Diabetes Endocrinology Research Centers (DERCs).
These Centers are part of an integrated program of diabetes-related
research support within the NIDDK.  Centers have provided a focus for
increasing the efficiency and collaborative effort among groups of
successful investigators at institutions with established
comprehensive diabetes research bases.  The NIDDK invites
applications for funding of two DERC grants to be competitively
awarded in Fiscal Year 1997.

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), Diabetes Endocrinology Research Centers, is
related to the priority area of diabetes mellitus.  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.  Racial/ethnic minority
individuals and women are encouraged to submit as Principal
Investigators.  Any institution with an outstanding, existing program
of biomedical research in the area of diabetes may apply for a DERC.
Foreign institutions are not eligible to apply.

MECHANISM OF SUPPORT

Support of this program will be through the National Institutes of
Health (NIH) center core grant (P30) award.  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 NIH National Center for Research
Resources may wish to identify the GCRC as a resource for reaching
the goals and objectives of the DERC.  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.  Responsibility for the
planning, direction, and execution of the proposed project will be
solely that of the applicant.  The total requested project period for
an application submitted in response to the RFA may not exceed five
years.  The maximum dollar request is limited to $750,000 in direct
costs for the initial budget period.  Budget escalations of four
percent may be requested for future years up to the $750,000 limit.
The earliest anticipated award date is December 1, 1996.

FUNDS AVAILABLE

The NIDDK anticipates awarding two DERC Grants in Fiscal Year 1997 on
a competitive basis.  The receipt of two competing continuation
applications is anticipated, which will be in competition with other
applications received in response to this RFA.  The anticipated award
will be contingent upon the availability of appropriated funds.
Requests for support must be limited to no more than $750,000 in
direct costs per year.  Any application exceeding the direct cost
amount indicated will be returned to the applicant.  The NIDDK has
allocated $2,156,000 in total costs to support this RFA.

RESEARCH OBJECTIVES

The objectives of the DERCs are to bring together investigators from
relevant disciplines in a manner that will enhance and extend the
effectiveness of research related to diabetes and its complications.
A diabetes center 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 DERC is to bring together on a cooperative basis, clinical and
basic science investigators in a manner that will enrich the
effectiveness of diabetes research.  For this purpose the applicant
must clearly state the considerations for center membership.

An existing program of excellence in biomedical research in the area
of diabetes and related metabolic and endocrine disorders in
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 a center.

The DERCs are based on the core concept.  Cores are defined as shared
resources that enhance productivity or in other ways benefit a group
of investigators working in diabetes or diabetes-related areas to
accomplish the stated goals of the Center.  These centers also
support a pilot and feasibility program and an enrichment program.

The pilot and feasibility program provides modest support for new
diabetes initiatives or feasibility research studies. This program is
directed at new investigators or established investigators in other
research disciplines when their expertise may be applied to diabetes
research. The Center grant may also include limited funds for program
enrichment such as seminars, visiting scientists, consultants,
workshops, etc.

Although funds are not provided directly for training purposes, the
core laboratories and program enrichment activities should provide
training opportunities for center members.

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 are
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 Minority in Study Populations) which have
been in effect since 1990.  The new policy contains some new
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 of March 18, 1994, Volume
23, Number 11.

Investigators may obtain copies from these sources or from the
program staff or contact person listed below. Program staff may also
provide additional relevant information concerning the policy.

LETTER OF INTENT

Prospective applicants are asked to submit, by January 25, 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
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 37-E,  MSC 6600
Bethesda, MD  20892-6600
Telephone:  (301) 594-8885
FAX:  (301) 480-3505

APPLICATION PROCEDURES

The research grant application 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 Office of Grants Information, Division of Research Grants,
National Institutes of Health, 6701 Rockledge Drive, Room 3034,
MSC-7762, Bethesda, MD 20892-7762, telephone 301/435-0714, email:
girg@drgpo.drg.nih.gov.

Applicants are strongly encouraged to request a copy of "Guidelines
for Diabetes Endocrinology Research Centers."  These guidelines
contain important suggestions and information on the format, content,
and review of applications and review criteria.  Prospective
applicants may obtain guidelines from and may address inquiries to
Dr. Sanford A. Garfield at the address listed under INQUIRIES.

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:

DIVISION OF RESEARCH GRANTS
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
45 Center Drive, Room 6AS 37E, MSC 6600
Bethesda, MD  20892-6600

Applications must be received by March 14, 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.

REVIEW CONSIDERATIONS

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.  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 appropriate national advisory council or board.

Review Criteria

o  scientific/technical merit criteria specific to the objectives of
the RFA;

o  scientific, technical, or medical significance and originality of
proposed research;

o  appropriateness and adequacy of the experimental approach and
methodology proposed to carry out the research;

o  qualifications and research experience of the Principal
Investigator and staff, particularly, but not exclusively in the area
of the proposed research;

o  availability of resources necessary to perform the research;

o  appropriateness of the proposed budget and duration in relation to
the proposed research; and

o  adequacy of plans to include both genders and minorities and their
subgroups as appropriate for the scientific goals of the research.
Plans for the recruitment and retention of subjects will also be
evaluated.

The initial review group will also examine the provisions for the
protection of human and animal subjects and the safety of the
research environment.

The initial review group will also review each application using the
criteria stated below and detailed in the DERC Guidelines:

New and Competing DERC Applications:

Biomedical Research

o  Scientific excellence of the Center's research base that must have
a broad and central focus in diabetes and may extend to related
research in metabolism and endocrinology.  The relevance of the
separately funded research to the DERC objectives (see above) and the
likelihood for meaningful collaboration among Center investigators
must be demonstrated.

o  Potential of the cores for contribution to ongoing research, their
appropriateness and relevance, their modes of operation and,
suitability of facilities. Renewal applications must include the use,
utility, quality control, cost effectiveness, and demonstrated
progress of any developmental research in the shared resources.

o  For new applications, the pilot and feasibility program is judged
on the basis of:  (1) scientific merit of the studies as submitted
and (2) the merit of the administrative process for selecting
subsequent studies. In competitive renewal applications, emphasis is
placed on the program as a whole, including past track record and
management of the program.

Research Training

o  Although the Center does not specifically support research
training, demonstration of accomplishments and future plans related
to the training of investigators necessary to conduct research in
diabetes and related metabolic and endocrine disorders will be
considered in assessing the potential to meet Center objectives.  The
integration of these efforts into the overall Center, including core
facilities is of particular importance.

Administration

o  The scientific and administrative leadership abilities of the DERC
Director and Associate Director and their commitment and ability to
devote adequate time to the effective management of the DERC program.

o  The appropriateness of the DERC budgets for the proposed and
approved work to be done in core facilities, for pilot and
feasibility studies, and for enrichment in relation to the total
Center program.

o  Efficiency and effectiveness of use and/or planned use of
enrichment funds.

o  Institutional commitment to the program, including lines of
accountability regarding management of the DERC grant and a
commitment to establish new positions as necessary.

AWARD CRITERIA

The earliest anticipated date of the award is December 1, 1996.
Applications will compete for available funds with all other
applications submitted in response to this RFA and recommended by
peer review.  The following will be considered in making funding
decisions:

o  Quality of the proposed Center as determined by peer review
o  Availability of funds

Schedule

Letter of Intent Receipt Date:    January 25, 1996
Application Receipt Date:         March 14, 1996
Initial Review Dates:             Jun/Jul 1996
Second Level Review Dates:        Sep/Oct 1996
Earliest Anticipated Award Date:  December 1, 1996

INQUIRIES

Inquiries concerning this RFA are encouraged.  The opportunity to
clarify any issues or questions from potential applicants is welcome.

Direct inquiries regarding programmatic issues and requests for the
DERC guidelines to:

Dr. Sanford A. Garfield
Division of Diabetes, Endocrinology, and Metabolic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
45 Center Drive, Room 5AN 24B, MSC-6600
Bethesda, MD  20892-6600
Telephone:  (301) 594-8803
FAX:  (301) 480-3503
Email:  GarfieldS@ep.niddk.nih.gov

Direct inquiries regarding fiscal and administrative matters to:

Linda Stechlein
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
45 Center Drive MSC 6600
Bethesda, MD  20892-6600
Telephone:  (301) 594-8847
Email:  StechleinL@ep.niddk.nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic
Assistance No. 93.847.  Awards are made under authorization of the
Public Health Service Act, Title IV, Part A (Public Law 78-410, as
amended by Public Law 99-158, 42 USC 241 and 285) and administered
under PHS grants policies and Federal Regulations 42 CFR 52 and 45
CFR Part 74.  This program is not subject to the intergovernmental
review requirements of Executive Order 12372 or Health Systems Agency
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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