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Full Text AI-93-018


NIH GUIDE, Volume 22, Number 21, June 11, 1993

RFA:  AI-93-018

P.T. 34

  Risk Factors/Analysis 
  Disease Prevention+ 

National Institute of Allergy and Infectious Diseases
National Institute of Arthritis and Musculoskeletal and Skin Diseases

Letter of Intent Receipt Date:  August 15, 1993
Application Receipt Date:  November 16, 1993


The Division of Allergy, Immunology and Transplantation of the
National Institute of Allergy and Infectious Diseases (NIAID) and the
Rheumatic Diseases Branch of the National Institute of Arthritis and
Musculoskeletal and Skin Diseases (NIAMS) invite studies aimed at
elucidating the causes and mechanisms of tolerance and autoimmune
diseases and at the application of this basic biomedical knowledge to
the development and implementation of new preventive and treatment
modalities for these diseases. This Request for Applications (RFA)
invites applications from collaborating basic science and clinical
research investigators who are interested in developing novel
integrated studies on autoimmune diseases.


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,
Program Projects on Autoimmunity, is related to the priority areas of
diabetes and chronic disabling diseases, and immunization and
infectious 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 202-782-3238).


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.
Applications from minority individuals and women are encouraged.


The mechanism of support will be the Program Project (P01) grant.
Multidisciplinary approaches that involve collaborative efforts among
investigators in the fields of basic immunology, molecular biology,
cell biology, biochemistry, genetics, and relevant medical
specialties are strongly encouraged.

The total project period for applications submitted in response to
this RFA may not exceed five years.  At this time, the NIAID is
administratively limiting the duration of P01 grants to four years;
this administrative limitation may change in the future. If, by the
beginning of the last year of support, the NIAID and NIAMS have not
announced intentions to readvertise the RFA, incumbents who wish to
recompete may consider reapplying using the investigator-initiated
Interactive Research Project Grant (IRPG) mechanism.  Applicants
should be alert to a program announcement concerning IRPGs published
in the NIH Guide for Grants and Contracts, Volume 22, Number 16,
April 23, 1993.  In such instances, incumbents are strongly
encouraged to contact NIAID Program Staff prior to submitting an


The estimated total funds (direct and indirect costs) available for
the first year of support for awards under this RFA will be
$2,300,000.  In Fiscal Year 1994, the NIAID and the NIAMS plan to
fund approximately three program projects.  Applications may not
request budgets in excess of $500,000 total direct costs in the first
year or more than 4 percent annual inflationary increases for future
years.  An application with a first year requested amount in excess
of $500,000 total direct cost will require written approval by senior
NIAID or NIAMS officials via the program officer for acceptance of
the application for processing.  The usual PHS policies governing
grants administration and management will apply.  This level of
support is dependent on the receipt of a sufficient number of
applications of high scientific merit.  Although this program is
provided for in the financial plans of the NIAID and the NIAMS,
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.


The major goals of these program projects are:  increased
understanding of etiology and pathogenetic mechanisms involved in
autoimmune diseases; generation of new information and the expansion
of the current knowledge base; and the application of this knowledge
to the development of new or improved measures of risk assessment,
prevention, early diagnosis and treatment of a wide variety of
autoimmune diseases and disorders in which the autoimmune response is
a major contributor to pathogenesis.

The NIAID and NIAMS are seeking innovative applications that address
various aspects of the immune responses related to self reactivity,
which may include studies concerned with relevant areas of genetics,
cell and molecular biology, biochemistry, physiology, microbiology,
pathology and pharmacology.  Of special interest are program projects
that emphasize new ideas, novel approaches, and state-of-the-art
technology in basic research that elucidates pathogenic mechanisms
and shows promise for clinical application in the prevention,
diagnosis, and treatment of autoimmune diseases.

There is overwhelming evidence to implicate immune mechanisms in the
pathogenesis of diseases of the skin, nervous system, endocrine
system, and gastrointestinal tract.  Thus, in addition to studies of
well-recognized autoimmune disorders such as systemic lupus
erythematosus, rheumatoid arthritis, antibody-mediated
thrombocytopenia and autoimmune hemolytic anemia, the NIAID and NIAMS
encourage investigators to design and develop studies aimed at
establishing the role of the immune system in the pathogenesis of
endocrine, dermatologic, neurologic and gastrointestinal diseases and
the development of new preventive and treatment modalities specific
for these disorders through the manipulation of the immune response.

Projects focused on the study of mechanisms of autoimmune diseases
should be designed based on integrated and coordinated
intra-institutional clinical investigations or experimental studies
with demonstrated relevance to human autoimmune disease.  Inclusion
of basic research components utilizing samples from human source
materials in in vitro procedures are encouraged, as are preclinical
studies using appropriate animal models of human autoimmune disease.
Inclusion of clinical investigative components drawing upon
immunologically relevant areas in medicine, pediatrics, surgery,
dermatology, neurology, pathology and their subspecialties is highly

Preparation of the Application

In preparing the application, the applicant should bear in mind the
research objectives of this RFA.  P01 applications should be prepared
using the guidance and instructions provided in the NIAID Information
Brochure for Program Project and Center Grants, which may be
requested from Dr. Rohrbaugh at the address listed under INQUIRIES.
Failure to follow these instructions may result in delays in the
review or in an incomplete application.



NIH policy requires that applicants for NIH clinical research grants
and cooperative agreements include minorities and women in study
populations so that research findings can be of benefit to all
persons at risk of the disease, disorder or condition under study;
special emphasis must be placed on the need for inclusion of
minorities and women in studies of diseases, disorders and conditions
which disproportionately affect them.  This policy is intended to
apply to males and females of all ages.  If women or minorities are
excluded or inadequately represented in clinical research,
particularly in proposed population-based studies, a clear compelling
rationale MUST be provided.

The composition of the proposed study population must be described in
terms of gender and racial/ethnic group, together with a rationale
for its choice.  In addition, gender and racial/ethnic issues should
be addressed in developing a research design and sample size
appropriate for the scientific objectives of the study.  This
information should be included in the form PHS 398 in items 1-4 of
the Research Plan AND summarized in item 5, Human Subjects.

Applicants are urged to assess carefully the feasibility of including
the broadest possible representation of minority groups.  However,
NIH recognizes that it may not be feasible or appropriate in all
research projects to include representation of the full array of
United States racial/ethnic minority populations [i.e., Native
Americans (including American Indians or Alaskan Natives),
Asian/Pacific Islanders, Blacks, Hispanics].  The rationale for
studies on single minority population groups should be provided.

For the purpose of this policy, clinical research includes human
biomedical and behavioral studies of etiology, epidemiology, (and
preventive strategies), diagnosis, or treatment of diseases,
disorders or conditions, including but not limited to, clinical

The usual NIH policies concerning research on human subjects also
apply.  Basic research or clinical studies in which human tissues
cannot be identified or linked to individuals are excluded. However,
clinical samples which may be coded for use by the applicant but
could be identified by another source are not excluded.  Every effort
should be made and documented to include human tissues from women and
racial/ethnic minorities when it is important to apply the results of
the study broadly, and this should be addressed by applicants.

For studies in foreign populations, the policy on inclusion of women
applies fully; since the definition of minority differs in other
countries, the applicant must discuss the relevance of research
involving foreign population groups to the U.S. populations,
including minorities.

If the required information is not contained within the application,
the application will be returned.

Peer reviewers will address specifically whether the research plan in
the application conforms to these policies.  If the representation of
women or minorities in a study design is inadequate to answer the
scientific question(s) addressed AND the justification for the
selected study population is inadequate, it will be considered a
scientific weakness or deficiency in the study design and will be
reflected in assigning the priority score to the application.

All applications for clinical research submitted to NIH are required
to address these policies.  NIH funding components will not award
grants or cooperative agreements that do not comply with these


Prospective applicants are asked to submit, by August 15, 1993, a
letter of intent that includes a descriptive title of the overall
proposed research, the name, address and telephone number of the
Program Director, the number and title of this RFA, and a list of the
key investigators and their institution(s).  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 and NIAMS 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


Applications are to be submitted on the standard research grant
application form PHS 398 (rev. 9/91).  For purposes of identification
and processing, item 2a on the face page of the application must be
marked "YES" and the RFA number and the words "PROGRAM PROJECTS ON
AUTOIMMUNITY" must be typed in.

These application forms may be obtained from the institution's office
for sponsored research or its equivalent, and from the Office of
Grants Inquiries, Division of Research Grants, National Institutes of
Health, 5333 Westbard Avenue, Room 449, Bethesda, Maryland 20892,
telephone (301) 710-0267.

It is highly recommended that the Chief of the Clinical Immunology
Branch, NIAID Division of Allergy, Immunology and Transplantation, or
the Chief of the NIAMS Rheumatic Diseases Branch be contacted in the
early stages of preparation of the application.  (See program
contacts in INQUIRIES, below.)

Applications must be received by November 16, 1993.

Applications that are not received by November 16, 1993, or that do
not conform to the instructions contained in PHS 398 (rev. 9/91)
application kit, will be judged non-responsive and will be returned
to the applicant.

The RFA label available in the application form PHS 398 must be
affixed to the bottom of the face page.  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.

Submit a signed, typewritten original of the application, including
the checklist, and three signed, exact, single-sided photocopies, in
one package to:

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

At the time of submission, two additional exact copies of the grant
application and all five sets of appendix material must also be sent
to Dr. Mark Rohrbaugh 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.


Upon receipt, applications will be reviewed for completeness by the
NIH Division of Research Grants (DRG) and for responsiveness by NIAID
and NIAMS staff; those judged to be incomplete or non-responsive will
be returned without review.

Those applications that are complete and responsive may be subjected
to a triage by a peer review group to determine their scientific
merit relative to other applications received in response to this
RFA.  The NIAID and the NIAMS will withdraw from competition those
applications judged to be non-competitive for award and will notify
the applicant and institutional business officials.

Those applications judged by the reviewers to be competitive for
award will be further reviewed for scientific and technical merit by
a review committee convened by the Division of Extramural Activities,
NIAID.  The second level of review will be provided by the National
Advisory Allergy and Infectious Diseases Council and/or the National
Arthritis and Musculoskeletal and Skin Diseases Council.

The factors to be considered in the evaluation of scientific merit of
each application will be those used in the review of traditional
research project grant applications, including:  the novelty,
originality, and feasibility of the approach; the training,
experience, and research competence of the investigator(s); the
adequacy of the experimental design; and the adequacy and suitability
of the facilities.  Additional review criteria used for program
project applications are outlined in the NIAID Information Brochure
on Program Project and Center Grants.  While the following review
factors do not usually influence the priority score, they are
nonetheless carefully considered by the initial review group:  the
appropriateness of the requested budget to the work proposed; the
adequacy of protection of human subjects and/or animals in research;
and the adherence, whenever appropriate, to NIH guidelines concerning
adequate representation of women and minorities in clinical research.
Any documented concerns expressed by the initial review group about
any of these factors on a given application may influence the
recommendation of the Advisory Council concerning funding of that


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

Direct inquiries regarding programmatic issues to:

Howard B. Dickler, M.D.
Division of Allergy, Immunology, and Transplantation
National Institute of Allergy and Infectious Diseases
Solar Building, Room 4A19
Bethesda, MD  20892
Telephone:  (301) 496-7104
FAX:  (301) 402-2571

Susana A. Serrate-Sztein, M.D.
Rheumatic Diseases Branch
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Westwood Building, Room 405
Bethesda, MD  20892
Telephone:  (301) 594-9953
FAX:  (301) 594-9673

Direct inquiries regarding review issues (including the
preparation of a program project application), address the letter of
intent to, and mail two copies of the application and all five
sets of appendices to:

Mark Rohrbaugh, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Solar Building, Room 4C22
6003 Executive Boulevard
Bethesda, MD  20892
Telephone:  (301) 496-8424
FAX:  (301) 402-2638

Direct inquiries regarding fiscal matters to:

Mr. Jeffrey Carow
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Solar Building, Room 4B29
6003 Executive Boulevard
Bethesda, MD  20892
Telephone:  (301) 496-7075


Letter of Intent Receipt Date:  August 15, 1993
Application Receipt Date:       November 16, 1993
Scientific Review Date:         February 1994
Advisory Council Date:          June 1994
Earliest Award Date:            August 1994


This program is described in the Catalog of Federal Domestic
Assistance, No. 93.855 - Immunology, Allergy and Transplantation
Research and No. 93.846 - Arthritis and Musculoskeletal and Skin
Diseases Research.  Awards will be made under the authority of the
Public Health Service Act, Title III, Section 301 (Public Law 78-410,
as amended; 42 USC 241) and administered under PHS grants policies
and Federal Regulations 42 CFR Part 74.  This program is not subject
to the intergovernmental review requirements of Executive Order 12372
or Health Systems Agency review.


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