DIABETES ENDOCRINOLOGY RESEARCH CENTER

Release Date:  July 29, 1998

RFA:  DK-98-021

P.T.

National Institute of Diabetes and Digestive and Kidney Diseases

Letter of Intent Receipt Date:  January 25, 1999
Application Receipt Date:  February 25, 1999

PURPOSE

The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
invites applications for a Core Center Grant to support research on diabetes
mellitus and its complications.  The NIDDK anticipates the award of one
competitive Diabetes Endocrinology Research Center in 1999.

Core Centers will provide shared resources to enhance the efficiency of research
and foster collaborations within and among institutions with established,
comprehensive bases of research relevant to diabetes mellitus.  Centers also
support a Pilot and Feasibility Program and an Enrichment Program.

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 RFA, Diabetes Endocrinology Research
Center, is related to the priority area of 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.  Racial/ethnic minority individuals, women, and persons with
disabilities are encouraged to apply as Principal Investigators.

Applicant institutions must have a strong existing base of high quality basic
and/or clinical research relevant to diabetes mellitus, including substantial
diabetes research support awarded through peer reviewed competition.

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.

This RFA is a one-time solicitation.  The NIDDK accepts P30 applications only
when submitted in response to an RFA.  The receipt of one competing continuation
application is anticipated.  This application will compete for one anticipated
award along 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.  The maximum dollar request is limited to $750,000 in
direct costs in any budget period.  Any indirect costs associated with
subcontracts are not included in the $750,000 direct cost limit.  Included in
this $750,000 may be a maximum of $150,000 for a pilot and feasibility program. 
Future budget period escalations may not exceed a 3 percent increase over the
previous budget period.  The earliest possible award date will be December 1,
1999.

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 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.

FUNDS AVAILABLE

For FY 1999, $930,000 will be committed to fund an application submitted in
response to this RFA.  It is anticipated that one award will be made.  The
receipt of one competing continuation application is anticipated, which will be
in competition together with the other applications received in response to this
RFA.  Funding is dependent upon the receipt of at least one application of high
scientific merit.  Although this program is provided for in the financial plans
of the NIDDK, the award of a grant pursuant to this RFA is also contingent upon
the availability of funds for this purpose.  Applicants must limit their requests
to not more than $750,000 direct costs for the initial budget period.  Any
indirect costs associated with subcontracts are not included in the $750,000
direct cost limit.  Future budget period escalations may not exceed a 3 percent
increase over the previous budget period.

RESEARCH OBJECTIVES

The Diabetes Endocrinology Research Centers (DERCs) are part of an integrated
program of support provided by the NIDDK for research in diabetes and related
areas of endocrinology and metabolism.  These centers have provided a focus for
increasing collaboration and cost effectiveness among groups of successful
investigators at institutions with an established, comprehensive, federally
supported diabetes research base.  DERCs are intended to improve the quality and
multidisciplinary nature of diabetes research by providing shared access to
specialized technical resources and expertise.  The overall goal of the DERC is
to bring together clinical and basic science investigators from relevant
disciplines in a manner which 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 institution such
as a university medical center or a consortium of cooperating institutions,
including an affiliated university.  An existing program of excellence in
biomedical research in the area of diabetes and related areas of metabolism and
endocrinology 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 essential to the success of a DERC.  Accordingly, the applicant
must clearly state the considerations for center membership.  It is also
appropriate and beneficial to define one or more central themes around which core
center research investigators are focused.

Diabetes research involves many specialized technologies and other resources,
which need to be integrated into a cohesive research program.  The objectives of
the DERC are to make these technologies and resources available to many
investigators and to promote a multifaceted approach to diabetes research by
providing shared resources to investigators with a wide variety of expertise. 
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.

Examples of possible biomedical core resources that would be considered
responsive to this Request for Applications include: molecular biology, islet
isolation, cell and tissue, cytohistochemistry, animal physiology, genetics,
vector, transgenic, immunology, protein chemistry and macromolecular structure,
analytical biochemistry, metabolism, mass spectrometry, immunoassay, morphology
and image analysis, monoclonal antibody/hybridoma, computer resource,
biostatistics, and clinical research. These possible cores are not listed in any
particular order nor do they represent a comprehensive list of cores that could
be supported under this Request for Applications.  Applicants are encouraged to
propose other cores that address the program objectives as stated above.

In addition to biomedical cores, an administrative core must be described which
will be responsible for allocation of resources within the Center and
distribution of resources to Center participants.  The Administrative core will
also be responsible for planning an enrichment program and convening a committee
to oversee the solicitation, review and selection of the pilot projects.

The DERCs 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 studies.  This program is directed at new
investigators or established investigators in other research disciplines whose
expertise may be applied to diabetes research.  The Center grant may also include
limited funds for an enrichment program to facilitate the exchange of information
between investigators who have research interests in the areas of diabetes,
endocrinology and metabolism.  The enrichment program can support activities such
as seminars, guest speakers, visiting scientists, consultants, workshops, etc. 
Although funds are not provided directly for training purposes, applicants may
wish to describe how the core laboratories and program enrichment activities will
provide training opportunities for center members.

Applicants are encouraged to consult with NIDDK staff concerning plans for the
development of a center and to request the NIDDK Administrative Guidelines for
preparing a core center application (See Application Procedures.)

Special Requirements

An existing program of excellence of biomedical research in the area of diabetes
and related endocrinology and metabolism research is required.  A substantial
research base, consisting of NIH and other peer-reviewed funded research
projects, is required to justify the requested Core support.  Suggestions for
describing and presenting this research base in the application are included in
the Administrative Guidelines (See Application Procedures).

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
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).

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 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 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 are scientific and ethical reasons not to include them.  This
policy 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

LETTER OF INTENT

Prospective applicants are asked to submit, by January 25, 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
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) 594-8885
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 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:
[email protected].

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.

Applicants should request a copy of Administrative Guidelines for NIDDK Core
Centers.  These guidelines contain important additional suggestions and
information on the format, content, and review of applications and review
criteria.  Prospective applicants may obtain guidelines from Dr. Judith Fradkin
at the address listed under INQUIRIES.

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 and all copies
of appendix material 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-37F, MSC 6600
Bethesda, MD  20892-6600

Applications must be received by February 25, 1999.  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

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 National Diabetes and Digestive and Kidney Diseases Advisory
Council.

The most important component of a DERC is the quality (strengths, breadth and
depth) of its established, independently supported, ongoing base of diabetes
research.  Specific review criteria are:

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, including their
appropriateness, impact, relevance, uniqueness, modes of operation, and
suitability of facilities.  Renewal applications must document the use, impact,
quality control, and cost effectiveness of each core, and demonstrate progress
of any developmental research in the cores.  Progress will be judged in part by
the publications supported by the cores.  While a minimum of two users (exclusive
of Pilot and Feasibility projects) are required to establish a core, a greater
number of users will be considered to be more cost effective.

o  Scientific and administrative abilities of the Center Director and Associate
Director and their commitment and ability to devote adequate time to the
effective management of the Core Center.

o  The qualifications, experience, accomplishments, and commitment of the Center
investigators and their inter-relatedness and collaborations.

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.

o   The Administrative organization proposed, including: coordination of ongoing
research; establishment and maintenance of internal communication and cooperation
among Center investigators; mechanisms for prioritizing usage of shares
resources; mechanisms of selecting and replacing essential personnel within the
Core Center; mechanisms for reviewing the use of and administering funds for the
P/F program; and management capabilities.

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

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

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.  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 will also be considered.

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

AWARD CRITERIA

The earliest anticipated date of award is December 1, 1999.  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: quality of the proposed Center as determined by peer
review; availability of funds; and program needs and balance.

INQUIRIES

Inquiries concerning this RFA are encouraged.  The opportunity to clarify any
issues or questions from potential applicants is welcome.  Applicants are also
encouraged to request the NIDDK Administrative Guidelines for preparing a core
center application

Direct inquiries regarding programmatic issues to:

Judith Fradkin, M.D.
Division of Diabetes, Endocrinology and Metabolic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
45 Center Drive, MSC 6600
Bethesda, MD  20892-6600
Telephone:  (301) 594-8814
FAX:  (301) 480-3503
Email:  [email protected]

Direct inquiries regarding fiscal and administrative matters to:

Kim Law
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
45 Center Drive, MSC 6600
Bethesda, MD  20892-6600
Telephone:  (301) 594-8869
FAX:  (301) 480-3504
Email:  [email protected]

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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