Full Text DK-96-012
NIH Guide, Volume 25, Number 20, June 21, 1996
RFA: DK-96-012
P.T. 34

  Biomedical Research, Multidiscipl 

National Institute of Diabetes and Digestive and Kidney Diseases
National Institute of Allergy & Infectious Diseases
Juvenile Diabetes Foundation International
Letter of Intent Receipt Date:  September 19, 1996
Application Receipt Date:  October 24, 1996
The National Institute of Diabetes and Digestive and Kidney Diseases
(NIDDK), the National Institute of Allergy and Infectious Diseases
(NIAID), and the Juvenile Diabetes Foundation International (JDFI)
invite investigator-initiated program project grant applications.
These applications should incorporate an interdisciplinary research
approach to:  (1) the development of innovative prevention and
treatment strategies for insulin-dependent diabetes mellitus (IDDM)
and/or its complications, (2) the etiology and pathogenesis of IDDM
and its complications, and/or (3) the genetic susceptibility for IDDM
and the complications of diabetes.  This solicitation is intended to
stimulate the application of advances in basic molecular biology,
genetics, immunology, cell biology, and biophysics to the study of
IDDM and its complications.
Applications will be submitted to and reviewed by the National
Institutes of Health (NIH) according to usual NIH peer review
procedures.  Applications judged meritorious but not funded by the
NIDDK and NIAID may be considered by the JDFI for funding.
Applicants wishing to have their application considered by the JDFI
must authorize the NIH, in writing, to provide a copy of their
application and NIH-prepared summary statement of the initial review
to the JDFI.
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 Interdisciplinary Research Programs, 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).
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.
The mechanism of support will be the NIH program project grant (P01)
award.  Program project grants are used to support broadly-based
multidisciplinary or multifaceted research programs that have a
specific major objective or central theme.  The award may support
research components and core functions.  Collectively, these
components should demonstrate essential elements of unity and
interdependence and result in a greater contribution to program goals
than if each activity were pursued individually.
Responsibility for the planning, direction, and execution of the
proposed project will be solely that of the applicant.  The current
policies and requirements that govern the research grant programs of
the NIH or the JDFI will prevail depending on the funding source.
Applicants should note that grants funded by the JDFI will be subject
to the indirect cost policy of JDFI.
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.
This RFA is a one-time solicitation.  The total requested project
period for an application submitted in response to this RFA may not
exceed five years.  The maximum dollar request is limited to $750,000
in direct costs for the initial budget period.  Any application
exceeding the direct cost amount indicated will be returned to the
applicant.  The maximum dollar request is limited to $3.75 million in
direct costs (approximately $5 million in total costs) for the
five-year budget period.  The earliest possible award date will be
July 1, 1997.
For FY 1997, the NIDDK will commit $1.5 million and the NIAID will
commit $250,000 (total costs) to fund applications submitted in
response to this RFA.  The NIDDK and NIAID anticipate awarding two
Diabetes Interdisciplinary Research Program (DIRP) Awards in Fiscal
Year 1997 on a competitive basis.  The JDFI plans to make two awards.
The receipt of four applications currently supported by NIDDK and
JDFI is anticipated, which will be in competition with other
applications received in response to this RFA.  This funding level is
dependent upon the receipt of a sufficient number of applications of
high scientific merit. Although this program is provided for in the
financial plan of the NIDDK and NIAID, the award of grants pursuant
to this RFA is also contingent upon the availability of funds for
this purpose.
General Background
The National Diabetes Advisory Board in 1987 formulated a National
Long-Range Plan to Combat Diabetes.  A number of significant
recommendations were made by the in this plan.  One of these was to
establish DIRPs to be supported by the NIH.  The DIRPs would promote
the integration of new research methodologies into diabetes research.
As a result of establishing these programs, new as well as
established scientists with diabetes research commitments would be
given the opportunity to immerse themselves in new technologies at
the cutting edge of modern science.
The NIDDK and NIAID are coordinating efforts with the JDFI to
implement DIRPs in areas of research that appear particularly
relevant to the cure, prevention, and improved treatment of IDDM.
Toward this end, the JDFI has embarked on a major long-term capital
fund raising campaign targeted at establishing programs of excellence
in diabetes research.
Scientific Background
It has been established that IDDM is an autoimmune disease with major
genetic influences.  Much has been learned about the nature of the
immunologic process involved but many questions remain.  Informative
animal models of IDDM (i.e., BB/Wor rat and NOD mouse) continue to be
a central focus of research.  Genes in the HLA locus have been
associated with IDDM, but the specific genes associated with this
locus have yet to be identified and the role of these gene products
in the pathogenesis has not been defined.
The Diabetes Control and Complications Trial has established the
crucial importance of metabolic control for preventing or delaying
the onset of diabetic complications.  The present methods for
achieving metabolic control are arduous, expensive, and only
partially effective.  Innovative approaches for maintaining
euglycemia are essential.
There is a great deal of epidemiologic, clinical, and physiologic
information on the long-term microvascular, macrovascular, and
neurologic complications of diabetes. There are also biochemical
theories of causation that have prompted research over the last
decade.  At this time, however, the molecular pathophysiology of
diabetic complications is still unclear.  Despite epidemiologic and
clinical evidence of genetic factors in the development of
complications, very little is known about the identity or function of
specific genes in these processes.
Recent advances in basic biomedical research have revolutionized our
ability to study complex diseases such as diabetes.  Further
application of the new capabilities of molecular biology, genetics,
immunology, cell biology, and biophysics to diabetes research are
essential. Importantly, the increased utilization of these
technologies and approaches promises an improved understanding and
enhanced development of potential preventive and therapeutic
Scope and Objectives
It is the intention of the NIDDK, NIAID and JDFI to further stimulate
the integration of the most current basic biomedical research
approaches into diabetes-related research.  It is expected that this
will be accomplished by bringing to the diabetes arena those who are
skilled in these approaches by the support of meritorious,
synergistic, multidisciplinary research program project applications.
Applications should include the involvement of both basic and applied
scientists in collaborative endeavors.  The JDFI will NOT consider
studies aimed at primary prevention for this particular RFA; however,
such studies would be within the scope of NIH support (see list of
examples below).
Research applications should be in the broad areas of etiology,
pathogenesis, prevention or cure of IDDM or its complications.
Relevant topics listed below are examples and should not be construed
as required or limiting.
o  Development of safe and effective techniques to maintain
euglycemia by biological or mechanical means, including investigation
of the metabolic performance and biocompatibility of the technique
o  Beta cell replacement therapies:  glucose sensors, implantable
pumps, and bio-artificial pancreas
o  Genetic manipulation of beta cells or surrogate cells to replace
physiologic insulin secretion capacity that has been destroyed in
o  Immunoalteration of beta cells/islets or the immune response in an
attempt to prevent autoimmune and graft- versus-host destruction of
beta cells/islets
o  Regulation of beta cell differentiation and its role in diabetes
o  Molecular mechanisms of beta cell destruction in IDDM
o  Identification and characterization of targets for the autoimmune
process in IDDM
o  IDDM prevention strategies to identify high risk individuals and
prevent the clinical onset of disease, perhaps by induction of
o  Identification and functional characterization of genes for IDDM
and IDDM-susceptibility
o  Identification and functional characterization of genes
influencing the development of long-term complications of IDDM
o  Identification of basic molecular or cellular processes leading to
complications and interventions to prevent or halt the progression of
long-term complications of diabetes
Letter of Authorization
Applicants should submit a brief letter to the NIH indicating whether
or not they wish their application to be considered for funding by
the JDFI.  While applicants may request that their applications be
considered only by the NIH and not by the JDFI, it is necessary that
the record indicate the applicant's consideration of this
opportunity.  For those applicants who wish to have the JDFI consider
their application, all materials relating to the application will be
promptly forwarded to that organization and the summary statements
for such applications will be shared with the JDFI when available.
The NIH will provide no information to the JDFI related to
applications from applicants who request that the JDFI not consider
their application.  Letters of authorization should be prepared by
the principal investigator and co-signed by the official signing for
the applicant organization.  This letter may be combined with the
Letter of Intent (see below) or may be submitted as a cover letter
accompanying the application.
In all cases, the NIDDK and NIAID will make their funding decisions
prior to those of the JDFI.
Periodic Meetings
Upon initiation of this program, the NIH and JDFI plan to sponsor
periodic meetings to encourage exchange of information among
investigators, to foster collaborative efforts among program
grantees, and to identify resources that would enhance the
productivity of grantees.  For this purpose, applicants should
request travel funds for a two-day meeting each year, probably to be
held in Bethesda, Maryland. Applicants should also include a
statement in their applications indicating their willingness to
participate in such meetings and to cooperate with other researchers
at other diabetes interdisciplinary research program sites.
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 Minorities in Study Populations) which
have been in effect since 1990.  The new policy contains some
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  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
Prospective applicants are asked to submit, by September 19, 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 subsequent applications, the information
that it contains is helpful in planning for the review of
applications. It allows NIH staff to estimate the potential review
workload and to avoid possible 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) 594-8886
FAX:  (301) 480-3505
The research grant application form PHS 398 (rev. 5/95) is to be used
in applying for these grants.  The form is available from most
institutional offices of sponsored research and from the 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.
Applicants should request a copy of the publication entitled "NIDDK
Program Projects Grants:  Administrative Guidelines."  These
guidelines contain important additional information on the suggested
format of applications and on review criteria.  Prospective
applicants may obtain these guidelines from:
Joan T. Harmon, Ph.D.
Diabetes Research Section
National Institute of Diabetes and Digestive and Kidney Diseases
45 Center Drive, MSC 6600
Bethesda, MD  20892-6600
Telephone:  (301) 594-8808
FAX:  (301) 480-3503
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, "Diabetes Interdisciplinary
Research Programs," and number, DK-96-012, 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, and three signed photocopies, in one package to:
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 October 24, 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.  However, it is
allowable to submit the same project as both an R01 and as a
component project of a program project.  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.
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.  It is not anticipated that site visits or applicant
interviews will be part of the review process; therefore, each
application should be complete in itself.  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 and the National
Advisory Allergy and Infectious Diseases Council.
Review Criteria
o  scientific, technical, or medical significance and originality of
proposed research, specific to the objectives of the RFA;
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  synergy of subprojects to achieve the goals of the program
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
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 anticipated date of the award is July 1, 1997.  Awards will be
based upon the following criteria:
o  scientific merit as determined by peer review
o  availability of funds
o  programmatic priorities of the funding Institute
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:
Joan T. Harmon, Ph.D.
Diabetes Research Section
National Institute of Diabetes and Digestive and Kidney Diseases
45 Center Drive, MSC 6600
Bethesda, MD  20892-6600
Telephone:  (301) 594-8808
FAX:  (301) 480-3503
Elaine Collier, M.D.
Chief, Autoimmunity Section
National Institute of Allergy and Infectious Diseases
6003 Executive Boulevard, MSC 7640
Solar Building, Room 4A20
Bethesda, MD  20892-7640
Telephone:  (301) 496-7104
FAX:  (301) 402-2571
Email:  ec5x@nih.gov
Direct inquiries regarding fiscal and administrative matters to:
Usha Ganti
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
45 Center Drive, MSC 6600
Bethesda, MD  20892-6600
Telephone:  (301) 594-8868
FAX:  (301) 480-3504
Pam Fleming
Division of Extramural Affairs
National Institute of Allergy and Infectious Diseases
6003 Executive Boulevard, MSC 7610
Solar Building, Room 4C25
Bethesda, MD  20892-7610
Telephone:  (301) 402-6580
FAX:  (301) 480-3780
Email:  pf49e@nih.gov
Letter of Intent Receipt Date:  September 19, 1996
Application Receipt Date:       October 24, 1996
Initial Review:                 February/March 1997
Second Level Review:            May 1997
Anticipated Date of Award:      July 1, 1997
This program is described in the Catalog of Federal Domestic
Assistance No. 93.847 and 93.855.  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 routing 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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