Full Text DK-97-005
NIH GUIDE, Volume 25, Number 39, November 15, 1996
RFA:  DK-97-005
P.T. 04, 44


National Institute of Diabetes and Digestive and Kidney Diseases
Letter of Intent Receipt Date:  February 12, 1997
Application Receipt Date:  March 12, 1997
The National Institute of Diabetes and 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 provide 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 five DRTC grants to be competitively
awarded in Fiscal Year 1998.
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 Summary Report:  Stock No.
017-001-00473-1) through the Superintendent of Documents, Government
Printing Office, Washington, DC 20402-9325 (telephone (202)
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.  Any institution with an existing,
outstanding 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.
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
The NIDDK anticipates awarding five DRTC grants in Fiscal Year 1998
on a competitive basis.  The receipt of five competing continuation
applications, which will be in competition together with the other
applications received in response to this RFA, is anticipated.  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.  Of this request at least
30 percent must be for the Demonstration and Education
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.  Any application exceeding the direct cost
amounts indicated will be returned to the applicant without review.
The NIDDK has allocated $8,779,000 in total costs to support this RFA
in Fiscal Year 1998 with an anticipated award date of December 1,
The NIDDK-supported Diabetes Centers program is comprised of DERCs
(P30) and DRTCs (P60).  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.  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 Division.  The D&E Division, which must be supported by at
least 30% of the DRTC budget, is composed of cores and projects: (1)
engaged in research in the translation of the outcomes of biomedical
and behavioral science research into clinical care; and (2)
development, testing, and evaluation of innovative methods and
programs for translation activities.  The D&E Division must include a
Model Demonstration Unit (MDU), which is a required component of a
DRTC.  The MDU should serve as a core facility for the conduct of
translation research and include as a central mission the
development, testing, and demonstration of model diabetes care.
Although located in the D&E Division it can span all Center
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; and (2) train
health professionals about diabetes and its management.  In addition,
the D&E Division of the DRTC: (3) must develop a model demonstration
facility to contribute to the above endeavors that ideally spans all
of the Center's activities, including basic and clinical research,
research training, development of model diabetes care and provision
of a core facility for translation research; and (4) translate
advances in the field of diabetes into improved care, such as the
translation of the intensive management shown to be effective by the
Diabetes Control and Complications Trial (DCCT).  The latter element
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, acknowledging the variety of
strengths present at diverse institutions.
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 the
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.
D&E projects for existing DRTCs submitting competing renewal
applications in response to this RFA must include an in-depth
progress report for projects that have ended, with a brief summary
progress report for projects that will be continued.  Indicate that
for the latter a complete report is presented under the related
project description section.
The D&E project descriptions should not include a project budget.
Instead, each proposed D&E project should indicate the percentage use
of the appropriate D&E Cores. The Budgets for conducting the proposed
work should be included with the associated cores.
These features are described briefly in this RFA and in detail in the
DRTC Guidelines (which can be obtained from the program official
listed under INQUIRIES below).  Each project or core description
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, 1997
(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 D&E Division.  In
addition, information (limited to five pages) should be included
describing how this D&E supplement 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 standard five year DRTC proposal for its
competing renewal.  (2) If the DERC will have less than one year of
support remaining after December 1, 1997, it must submit a full DRTC
application.  If funded the DRTC would have a five-year award period.
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.
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) 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 in the
NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18,
Investigators also may obtain copies of the policy from program staff
listed under INQUIRIES.  Program staff may also provide additional
relevant information concerning the policy.
Prospective applicants are asked to submit, by February 12, 1997, 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.
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
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
Applications are to be submitted on the grant application form PHS
398 (rev. 5/95).  Application kits are available at most
institutional offices of sponsored research, or may be obtained from
the Grants Information Office, Office of Extramural Outreach and
Information Resources, National Institutes of Health, 6701 Rockledge
Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301-710-0267,
email: asknih@odrockm1.od.nih.gov.
The RFA label available in the PHS 398 (rev. 9/95) 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, exact photocopies, in one package
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 under separate cover to:
Chief, Review Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney
Room 6AS-37F
45 Center Drive MSC 6600
Bethesda, MD  20892-6600
Applications must be received by March 12, 1997.  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.
Applications that are complete 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 may 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 advisory council.
The initial review group will review each application using the
criteria stated below and detailed in the DRTC Guidelines for new and
competing DRTC applications.
1.  Biomedical Research
There must be scientific excellence of the Center's research base as
indicated by peer reviewed extramural funding and this research base
must have a broad and central focus in diabetes which may extend to
related research in metabolism and endocrinology.  Also, 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.
The potential of the cores to contribute to ongoing research, the
appropriateness and relevance of the cores, their modes of operation,
and the suitability of facilities will be assessed.  Renewal
applications must include the use, utility, quality control, cost
effectiveness, and demonstrated progress of any developmental
research in the shared resources.
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.
The adequacy of plans to include both genders and minorities in
meeting the scientific goals of the research must be shown. Plans for
the recruitment and retention of subjects will also be evaluated.
2.  Research Training
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
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:
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.  Evaluation activities assessing the success of these
programs should be reported.
Organization and use of the Model Demonstration Unit which is a
required component of the DRTC.
For existing Centers, future plans for continuing ongoing activities
and initiating new activities and their evaluation.
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 should be indicated.
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.) should be indicated.
Consideration should be given to the potential impact of proposed
activities on the national diabetes effort.
4.  Supplemental Demonstration and Education Unit Applications (only
for DERCs proposing conversion to DRTCs:
The supplement will be evaluated on the basis of the D&E criteria
presented above.
The D&E supplement should carefully present the rationale for
extending the currently funded DERC to include this new element.
How interfacing the additional D&E element to the existing DERC will
impact on the overall activities of the Center.
The overall rating of the DERC plus the 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
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
will be assessed.
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
will be evaluated.
Efficiency and effectiveness of use and/or planned use of enrichment
funds should be clear.
There should be significant institutional commitment to the program,
including lines of accountability regarding management of the DRTC
The anticipated date of the award is December 1, 1997. Applications
will compete for available funds with all other applications
submitted in response to this RFA and as 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
o  Program priorities
Inquiries concerning this RFA are encouraged.  The opportunity to
clarify any issues or questions from potential applicants is welcome.
Direct inquiries regarding programmatic issues 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 24-B, MSC-6600
BETHESDA MD 20892-6600
Telephone: (301) 594-8803
FAX: (301) 480-3503
E-mail: GarfieldS@ep.niddk.nih.gov
Direct inquiries regarding fiscal and administrative matters to:
Linda Stecklein
Grants Management Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
BETHESDA, MD 20892-6600
Telephone:  (301) 594-8847
E-mail: SteckleinL@ep.niddk.nih.gov
Letter of Intent Receipt Date:  February 12, 1997
Application Receipt Date:       March 12, 1997
Initial Review Dates:           June-July 1997
Second Level Review Dates:      September-October 1997
Anticipated Award Date:         December 1, 1997
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
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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