Full Text AI-95-005


NIH GUIDE, Volume 24, Number 1, January 13, 1995

RFA:  AI-95-005

P.T. 34

  Biomedical Research, Multidiscipl 

National Institute of Allergy and Infectious Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
Juvenile Diabetes Foundation International

Letter of Intent Receipt Date:  March 15, 1995
Application Receipt Date:  June 15, 1995


The National Institute of Allergy and Infectious Diseases (NIAID) and
the National Institute of Diabetes and Digestive and Kidney Disease
(NIDDK) of the National Institutes of Health (NIH) and the Juvenile
Diabetes Foundation International (JDFI) invite applications for
program project grants to support interdisciplinary programs in
autoimmune disease.  This Request for Applications (RFA) will support
programs combining investigations of basic, molecular, immunologic,
and genetic mechanisms in the pathogenesis of autoimmunity and the
development of innovative therapies for human autoimmune disease.
These programs may incorporate investigation into any autoimmune
disease, including, but not limited to, Insulin Dependent Diabetes
Mellitus (IDDM), or any field of science with relevance to the
mechanisms and treatment of autoimmunity.  Programs utilizing
investigators from different scientific disciplines are particularly
desirable, so as to utilize expertise in several areas

Applications should be submitted to and will be reviewed by the NIH
according to the usual NIH peer review procedures.  Funds for each
Program Project to be awarded under this RFA will be provided by the
NIAID and the JDFI.  One or more program projects will be cofunded by


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,
Interdisciplinary Programs in Autoimmune Disease, is related to the
priority area of diabetes and chronic disabling diseases.  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


Research grant applications may be submitted by domestic for-profit
and non-profit organizations, public and private institutions, such
as universities, colleges, hospitals, laboratories, units of State
and local governments, and eligible agencies of the Federal
government.  Foreign organizations are not eligible to apply.
Racial/ethnic minority individuals, women, and persons with
disabilities are encouraged to apply as Principal Investigators.


The mechanism of support will be the program project (P01) grant.
This mechanism supports broadly based multi-disciplinary research
programs that have a well-defined central research focus, theme, or
objective.  An important feature of the program project is that the
interrelationships of the individual scientifically meritorious
projects will result in a greater contribution to the overall program
goals than if each project were pursued individually.  The program
project grant consists of a minimum of three interrelated individual
research projects that contribute to the program objective.  The
program project grant also can provide support for certain common
resources termed cores.  Such resources should be utilized by two or
more projects within the program project.

Responsibility for the planning, direction, and execution of the
proposed project will be solely that of the applicant.  The total
project period may not exceed five years.  At this time, the NIAID is
administratively limiting the duration of P01 grants to four years.
The earliest anticipated award date is March 1996.


The estimated total funds (direct and indirect costs) available for
the first year of support for this RFA will be $2.75 million:  $1.5
million from NIAID; $1.0 million from JDFI; and $250,000 from NIDDK.
In Fiscal Year 1996, the NIAID and the JDFI anticipate jointly
funding approximately three or four program projects related to this
RFA.  Approximately 60 percent of the total costs of each grant will
be funded by the NIAID and approximately 40 percent by the JDFI.  One
or more of these applications will be cofunded by the NIDDK.  This
level of support is dependent on the receipt of a sufficient number
of applications of high scientific merit.  Applications may not
request budgets in excess of $750,000 total (direct and indirect)
costs in the first year.  The NIH is currently limiting annual
inflationary increases to no more than four percent for future years.
Funding rules and policies, including the determination of allowable
indirect costs, of each funding organization will be applicable.
Post award administration will conform to current policies and
requirements that govern the research grant programs of the NIH and
the JDFI as appropriate.  Although this program is provided for in
the financial plans of the NIAID, the JDFI, and the NIDDK, awards
pursuant to this RFA are contingent upon the availability of funds
for this purpose.  Funding beyond the first and subsequent years of
the grant will be contingent upon satisfactory progress during the
preceding years and availability of funds.  At this time, it has not
been determined whether or how this solicitation will be continued
beyond the period stated in the present RFA.

The National Institute of Arthritis, Musculoskeletal and Skin
Diseases (NIAMS) is interested in research on the immune mechanisms
involved in rheumatic diseases and the development of new therapies
for these diseases based on manipulation of the immune system.
Applications that are of mutual interest are likely to be given dual
secondary assignment to the NIAMS in accordance with NIH Division of
Research Grants (DRG) referral guidelines.



Autoimmune diseases affect five to seven percent of the population,
resulting in significant morbidity and mortality, and cost billions
of dollars annually for health care and loss of productivity.
Insulin Dependent Diabetes Mellitus (IDDM) disproportionately affects
children and young adults.  In addition to IDDM, other diseases
included in this category are rheumatoid arthritis, systemic lupus
erythematosus, multiple sclerosis, and inflammatory bowel disease.
There is no known cure or prevention for these diseases.  However,
recent developments, including new animal models, the ability to
generate transgenic animals, recent new paradigms for the stimulation
of T and B cells, the finding of new co-factors for stimulation, and
the development of new methods for detecting self-antigens, have
revolutionized our thinking about the development of tolerance, both
central and peripheral.  These new developments in basic immunology
may lead to important insights into the pathogenesis and therapy of
autoimmune disease.

Research Objectives and Scope

Application of recent advances in basic immunology to the
understanding of the pathogenesis of autoimmune diseases, including
the development of novel therapies and possible preventive
strategies, is a major goal of this RFA.  The specific objectives of
this program are to: facilitate the application of new advances in
immunology and immunogenetics to the understanding and treatment of
autoimmune diseases, including IDDM; increase the understanding of
the etiology and pathogenic mechanisms involved in development and
progression of autoimmune diseases; enable investigators working on
various different autoimmune diseases to come together to work in a
collaborative and synergistic way; and promote the collaboration
between investigators working in disease-specific models and
investigators focusing on basic studies of self tolerance and the
defects in this process in several experimental systems.  In addition
to investigation of the initiation of the autoimmune process, the
mechanism of the target organ damage in autoimmune disease is
unclear.  The elucidation of the destructive pathways resulting from
the autoimmune process in these diseases could be useful for the
development of therapeutic strategies and is a relevant topic for
this RFA.  The inclusion of clinical investigators may allow earlier
transfer of new information to the clinical setting.


The NIAID, the NIDDK, and the JDFI plan to sponsor an annual meeting
to encourage the exchange of information among investigators
supported under this RFA, foster collaborative efforts, and identify
resources that would enhance the productivity of this research
program.  Applications should include a statement indicating the
willingness of the applicant institution to participate in such
annual meetings.  For this purpose, travel funds for an annual two-
day meeting, to be held in the Washington, DC area, should be
included in the budget request.

Letter of Authorization

This RFA is co-sponsored by the JDFI.  In order for an application to
be considered for funding by the JDFI, applicants must submit a brief
letter of authorization co-signed by the Principal Investigator and
the official signing for the applicant institution, authorizing
release of the application and all related materials to the JDFI.
This letter of authorization may be combined with the letter of
intent or may be submitted directly to Dr. Elaine Collier at the
address listed under INQUIRIES.  The summary statement for such
applications will be shared with the JDFI at the time of their
availability.  Applications without such authorization will not be
considered for funding by the JDFI.


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

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


Prospective applicants are asked to submit, by March 15, 1995, a
letter of intent that includes a descriptive title of the overall
proposed research, the name, address, and telephone number of the
Principal Investigator, a list of the key investigators and their
institution(s), and the number and title of this RFA.  Although the
letter of intent is not required, is not binding, does not commit the
sender to submit an application, and does not enter into the review
of subsequent applications, the information that it contains allows
NIAID staff to estimate the potential review workload and to avoid
conflict of interest in the review.

The letter of intent is to be sent to Dr. Mark Rohrbaugh at the
address listed under INQUIRIES.


Applications are to be submitted on form PHS 398 (rev. 9/91), the
standard application form for research grants.  Application kits 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, Westwood Building,
Room 449, Bethesda, MD 20892, telephone 301/710-0267.  Applicants
must adhere to the format and requirements specified in the PHS 398
application kit.  In addition, applicants for multicomponent grants
are strongly advised to read the information brochure "NIAID Program
Project Grants and Multiproject Cooperative Agreements", available
from Dr. Elaine Collier at the address listed under INQUIRIES.

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 could be included
with the application.

For purposes of identification and processing, mark "YES" in item 2a
on the face page of the application and type in the RFA number,
DISEASE."  The RFA label available in the form PHS 398 must be
affixed to the bottom of the face page of the original 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.

The signed, typewritten original of the application, including the
Checklist, and three exact single-sided copies must be sent to:

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

At the time of submission, two additional copies and all five sets of
appendices must also be sent to Dr. Mark Rohrbaugh at the address
listed under INQUIRIES.  To ensure their review, applications must be
received by both the Division of Research Grants and Dr. Mark
Rohrbaugh by June 15, 1995.  Applications not received by June 15,
1995 will be considered non-responsive and will be returned to the
applicant without review.

Concurrent submission of an R01 and a Component Project of a Multi-
project Application:

Current NIH policy permits a component research project of a multi-
project grant application to be concurrently submitted as a
traditional individual research project (R01) application.  If,
following review, both the multi-project application and the R01
application are found to be in the fundable range, the investigator
must relinquish the R01 and will not have the option to withdraw from
the multi-project grant.  This is an NIH policy intended to preserve
the scientific integrity of a multi-project grant, which may be
seriously compromised if a strong component project(s) is removed
from the program.  Investigators wishing to participate in a multi-
project grant must be aware of this policy before making a commitment
to the Principal Investigator and awarding institution.


Review Procedures

Upon receipt, applications will be reviewed for completeness by the
Division of Research Grants (DRG) and for responsiveness by the
NIAID.  Incomplete and/or non-responsive applications will be
returned to the applicant without further consideration.

Complete and responsive applications will be evaluated for scientific
and technical merit by an appropriate peer review group convened by
the NIAID 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 their scientific merit
relative to other applications received in response to the RFA.
Applications judged to be competitive will be discussed and will be
assigned a priority score.  Applications determined to be non-
competitive will be withdrawn from further consideration and the
Principal Investigator and the official signing for the applicant
organization will be notified.  The second level of review will be
provided by the National Advisory Allergy and Infectious Diseases
Council and the National Institute of Diabetes and Digestive and
Kidney Diseases Advisory Council.

Review Criteria

The review criteria for P01 grant applications are the review
criteria for large, multicomponent, interdisciplinary program
projects as outlined in the NIAID brochure entitled "NIAID Guidelines
for Multiproject Research Awards."  The program project grant
application should include a justification for the appropriateness of
that granting mechanism for the proposed project.  The distinguishing
features of a program project grant include:

o  A well-defined, unifying goal or problem area of research to which
each project relates and contributes, thereby producing a research
environment that allows each research effort to share the creative
strengths of others.

o  A program director who possesses recognized scientific and
administrative competence.  He/she must demonstrate a substantial
commitment to the program in time and effort thereby exercising
leadership in providing overall direction and in upholding rigorous
scientific conduct.

o  Each research project must, as assessed by peer review, stand on
its own independent scientific merit, as well as complement other
projects whenever feasible.

o  The projects require the participation of established
investigators in several disciplines or investigators with special
expertise in several areas of one discipline.  All investigators must
contribute to and share the responsibilities of fulfilling the
program objective.

o  Ability of the proposed research to provide knowledge of basic,
molecular and genetic mechanisms in the pathogenesis of autoimmunity
and the development of innovative therapies for human autoimmune
disease.  The appropriateness of the proposed experimental plan to
validate the utility of the chosen strategy will be considered in
this regard.

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


Funding decisions will be made on the basis of scientific and
technical merit as determined by peer review, program priorities, and
the availability of funds.


Written and telephone inquiries concerning this RFA are encouraged.
The opportunity to clarify any issues or questions from potential
applicants is welcome.

Requests for the brochure "NIAID Application Guidelines for
Multiproject Research Awards," as well as inquiries regarding
programmatic issues may be directed to:

Elaine Collier, M.D.
Division of Allergy, Immunology, and Transplantation
National Institute of Allergy and Infectious Disease
Solar Building, Room 4A20
6003 Executive Boulevard
Bethesda, MD  20892-7640
Telephone:  (301) 496-7104
FAX:  (301) 402-2571
Email:  EC5X@NIH.GOV

Joan Harmon, Ph.D.
Division of Diabetes, Endocrinology, and Metabolic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
Natcher Building, Room 5AN-18G
Bethesda, MD  20892
Telephone:  (301) 594-8808
FAX:  (301) 480-3503
Email:  joanh@dvsgate.niddk.nih.gov

Direct inquiries regarding review issues, mail two copies of the
application and all five sets of appendices, and mail the letter of
intent to:

Mark L. Rohrbaugh, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Solar Building, Room 4C20
6003 Executive Boulevard
Bethesda, MD  20892-7610
Telephone:  (301) 496-8424
FAX:  (301) 402-2638
Email:  MR28K@NIH.GOV

Direct inquiries regarding fiscal matters to:

Ms. Jacqueline Johnson
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Solar Building, Room 4B26
6003 Executive Boulevard
Bethesda, MD  20892-7610
Telephone:  (301) 496-7075
Email:  JJ19E@NIH.GOV


Letter of Intent Receipt Date:  March 15, 1995
Application Receipt Date:       June 15, 1995
Scientific Review Date:         October 1995
Advisory Council Date:          January 1996
Earliest Award Date:            March 1996


This program is described in the Catalog of Federal Domestic
Assistance, No. 93.855 and No. 93.847.  Awards will be made under the
authority 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 (PHS) strongly encourages all grant
recipients to provide a smoke-free work place and promote the nonuse
of all tobacco products.  This is consistent with the PHS mission to
protect and advance the physical and mental health of the American


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