Full Text DK-95-001

DIABETES RESEARCH AND TRAINING CENTER

NIH GUIDE, Volume 23, Number 35, October 7, 1994

RFA:  DK-95-001

P.T. 04

Keywords: 
  Diabetes 
  Biomedical Research Training 
  Biomedical Research, Multidiscipl 


National Institute of Diabetes and Digestive and Kidney Diseases

Letter of Intent Receipt Date:  February 16, 1995
Application Receipt Date:  March 16, 1995

PURPOSE

The National Institute of Diabetes, Digestive and Kidney Diseases
(NIDDK) supports six Diabetes Research and Training Centers (DRTCs).
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
one DRTC grant to be competitively awarded in Fiscal Year 1996.

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 Research and Training 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 "Healthy People 2000" (Summary Report:
Stock No. 017-001-00473-1) through the Superintendent of Documents,
Government Printing Office, Washington, DC 20402-9325 (telephone (202)
783-3238).

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.  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 DRTC.  In addition,
existing Diabetes Endocrinology Research Centers (DERCs) may submit
competing applications for conversion to DRTCs.  Foreign institutions
are not eligible to apply.

MECHANISM OF SUPPORT

This RFA is a one time solicitation.  Support of this program will be
through the National Institutes of Health (NIH) comprehensive center
(P60) award.  Responsibility for the planning, direction, and execution
of the proposed project will be solely that of the applicant.  In
addition to the requirements stated in this RFA, awards will be
administered under PHS grants policy as stated in the PHS Grants Policy
Statement.

FUNDS AVAILABLE

The NIDDK anticipates awarding one DRTC Grant in Fiscal Year 1996 on a
competitive basis.  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.  The
anticipated award will be contingent upon the availability of
appropriated funds.  Requests for support must be limited to no more
than $1,250,000 in direct costs per year.  Requests for support for
Demonstration and Education (D&E) supplements to convert an existing
DERC to a DRTC must be limited to $300,000 in direct costs.  If
awarded, the D&E supplement funding would be added to the level of the
existing DERC budget.  The $1,250,000 direct cost application limit
would then apply to future DRTC competing renewals.  The NIDDK has
allocated $1,657,000 in total costs to support this RFA.  Any
application exceeding the direct cost amounts indicated will be
returned to the applicant without review.

RESEARCH OBJECTIVES

The NIDDK-supported Diabetes Centers program is comprised of DERCs and
DRTCs.  The objective of the Diabetes Research Center is to bring
together investigators from relevant disciplines in a manner which will
enhance and extend the effectiveness of research and training being
conducted in the field of diabetes and its complications.  These
Centers have provided a focus for increasing collaboration and cost
effectiveness among groups of successful investigators at institutions
with established comprehensive diabetes research bases.

Both types of centers 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
initiatives or feasibility research studies for new investigators or
for established investigators in other research disciplines when their
expertise may be applied to diabetes research.  These include
biomedical, epidemiologic, behavioral, and health care research as it
pertains to the Center's mandate for the training of primarily health
care professionals.  The Center grant may also include limited funds
for program enrichment such as seminars, visiting scientists,
consultants, workshops, etc.

While the above components are common to DERCs and DRTCs, DRTCs also
include a substantial additional component, the Demonstration and
Education (D&E) Division.  The D&E Division:  (1) carries out training
programs for health care professionals, (2) is engaged in research in
the translation of the outcomes of biomedical and behavioral science
research into clinical care, and (3) develops, tests, and evaluates
innovative methods and programs for translation activities.  These
features are described briefly in this RFA and in detail in the DRTC
Guidelines.  Each project or core within the D&E Division may not
exceed 25 pages.

A DERC is eligible to apply for conversion to the DRTC program.  An
existing DERC that elects to apply for such conversion in response to
this RFA must follow the following procedures:  (1) if the DERC will
have at least one year of support remaining as of December 1, 1995 (the
earliest funding date for applications submitted in response to this
RFA), a competing supplement to the existing DERC may be submitted
which includes only the components of a Demonstration and Education
Division.  In addition, information (limited to five pages) should be
included describing how this D&E addition will interact with the
existing DERC elements and enhance the comprehensive nature of the
Center.  A successful competition would result in the DERC being
converted to a DRTC for the duration of that Center's current award.
It would then be eligible to submit a DRTC proposal for its competing
renewal.  (2) If the DERC will have less than one year of support
remaining after December 1, 1995, it must submit a full DRTC
application.  If funded the DRTC would have a five year award period.

A DRTC 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 DRTC is to bring
together on a cooperative basis, clinical and basic science
investigators and those involved in diabetes education and translation.
As indicated above, the DRTCs are expected to encompass the following:
(1) facilitate and strengthen basic and clinical research related to
diabetes and its complications; (2) train health professionals about
diabetes and its management.  In addition, within the D&E Division of
the DRTC:  (3) develop a model demonstration facility to contribute to
the above endeavors; and, (4) translate advances in the field of
diabetes into improved care, especially, the translation of the
intensive management shown to be effective by the Diabetes Control and
Complications Trial (DCCT).  The latter should focus on research to
identify and overcome barriers to intensive diabetes management and
treatment.  All of these areas need not be developed to the same
degree.

A strong base of biomedical research is an essential prerequisite of a
Center.  Accordingly, a program of excellence in biomedical research in
the area of diabetes and related metabolic and endocrine disorders in
the form of NIH-funded research projects, program projects, or other
peer-reviewed research must be in existence at the time of submission
of a Center application.  Close cooperation, communication, and
collaboration among all involved personnel of all professional
disciplines to enhance research progress are ultimate objectives.
Applicants should request a copy of the DRTC guidelines and consult
with NIDDK staff concerning plans for the development of the Center.

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.

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)
ad 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 in the NIH
Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994.

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

LETTER OF INTENT

Prospective applicants are asked to submit, by February 16, 1995, 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 subsequent applications, the information
that it contains is helpful in planning for the review of applications.
It allows NIDDK staff to estimate the potential review workload and to
avoid possible conflict of interests in the review.

Prospective applicants may submit letters of intent to:

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

APPLICATION PROCEDURES

Applicants are strongly encouraged to request a copy of "Guidelines for
Diabetes Research and Training 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 the program official listed under INQUIRIES.

Applications are to be submitted on the form PHS 398 (rev. 9/91)
available at most institutional offices of sponsored research and from
the Office of Grants Information, Division of Research Grants, National
Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD
20892, telephone (301) 435-0714.

The RFA label available in the PHS 398 (rev. 9/91) 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 2a
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, exact photocopies, in one package to:

Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892**

At time of submission, two additional copies of the application must
also be sent under separate cover to:

Chief, Review Branch
Division of Extramural Activities
National Institute of Diabetes and Disgestive and Kidney Diseases
45 Center Drive MSC 6600
Bethesda, MD  20892-6600

Applications must be received by March 16, 1995.  If an application is
received after that date, it will be returned to the applicant.  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. Such applications must
not only include an introduction addressing the previous critique but
also be responsive to this RFA.

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 the review
criteria stated below.  As part of the initial merit review, a process
(triage) may be used by the initial review group in which applications
will be determined to be competitive or non-competitive based on the
scientific merit relative to other applications received in response to
the RFA.  Applications judged to be competitive will be discussed and
be assigned a priority score.  Applications determined to be
non-competitive will be withdrawn from further consideration and the
principal investigator/program director and the official signing for
the applicant organization will be promptly notified.  It is essential
that the written application be in a form to be reviewed on its own
merit, since no site-visit is anticipated.  Following this review, the
applications will be given 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 detailed in the DRTC
Guidelines:

New and Competing DRTC Applications:

1.  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 DRTC 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.

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

2.  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.

3.  Demonstration and Education

o  The applicant's existing or planned activities to overcome barriers
to translating research knowledge into improved diabetes health care
will be evaluated on the basis of:

(a) The novelty, feasibility, and quality of programs, materials, and
publications that address overcoming barriers to translation of
scientific advances into clinical practice.  This should include
program and/or curriculum development in the education of health care
professionals (including students) both within and outside the DRTC.
Completed programs and materials should be translatable to other
settings and should have undergone some form of evaluation.

(b) Organization and use of the Model Demonstration Unit which is a
required component of the DRTC.  The MDU should include as a central
mission the development, testing, and demonstration of model diabetes
care. Ideally it should span all the Center activities, including basic
and clinical research, research training and training of health
professionals.

(c) For existing Centers, future plans for continuing ongoing
activities and initiating new activities and their evaluation.

(d) The approach, results, and general utility of any outreach
projects, including:  transferability to other settings, demonstrated
effectiveness, and plans for take over by local groups and/or funding
from other sources.

(e) Overall coordination and cooperation within the D&E component among
the cores of the DRTC and with other groups (voluntary health
organizations, Federal agencies, and other diabetes-related efforts,
etc.).

(f) Consideration of the potential impact of the activity on the
national diabetes effort.

4.  Supplemental Demonstration and Education Unit Applications:

o  The supplement will be evaluated on the basis of the D&E criteria
presented above.

o  The D&E supplement should carefully present the rationale for
extending the currently funded DERC to include this new element.

o  The interfacing of the additional D&E element to the existing DERC.
How does this extension impact on the overall activities of the Center?

o  The overall rating of the DERC plus D&E supplement for conversion to
a DRTC will be based on the above stated D&E criteria in addition to
the existing DERC framework. The latter will take into consideration
the previous DERC Summary Statement.  The DERC elements will not be
re-reviewed.

5.  Administration

o  The scientific and administrative leadership abilities of the DRTC
Director and Associate Director and their commitment and ability to
devote adequate time to the effective management of the DRTC 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 anticipated date of the award is December 1, 1995.  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

INQUIRIES

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

Dr. Sanford A. Garfield
Division of Diabetes, Endocrinology, and Metabolic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
Westwood Building, Room 626
45 Center Drive MSC 6600
Bethesda, MD  20892-6600
Telephone:  (301) 594-7535
FAX:  (301) 594-9011
Email:  sandyg@dvsgate.niddk.nih.gov

Direct inquiries regarding fiscal matters to:

Ms. Linda Stecklein
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
Westwood Building, Room 653
45 Center Drive MSC 6600
Bethesda, MD  20892-6600
Telephone:  (301) 594-7543

Schedule

Letter of Intent Receipt Date:  February 16, 1995
Application Receipt Date:       March 16, 1995
Initial Review Dates:           June-July 1995
Second Level Review Dates:      Sep-Oct 1995
Anticipated Award Date:         December 1, 1995

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 Public Health Service strongly encourages all grant recipients to
provide a smoke-free workplace and promote the non-use of all tobacco
products.  This is consistent with the PHS mission to protect and
advance the physical and mental health of the American people.

.

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