Subject: NIH GUIDE - RFA AI-91-09 - V20(23) 06/14/91
From: Dot Baker <[email-masked]>
To: [email-masked]
Date: Thu, 13 Jun 91 11:39 EST

Hi Paul:
The 6-14-91 NIH Guide has arrived with one separate RFA.  Please post
this one as RFAAI-91-09.910614.
     Paul, Dottie will be out for the next six or seven weeks.  I will
be doing this for a while.  If you receive some of the items that are
not in the proper format, please give me a call and let me know what
title was sent.  Also, if you would please double check and post
in the proper format.
                          Mary Broaddus, 6-5625
 ---------------------------- Text of forwarded message -----------------------
 
$$XID RFA AI9109 AI-91-09 P1O1 *****************************************
 
REQUEST FOR APPLICATIONS
 
RFA:  AI-91-09
 
PROGRAM PROJECTS ON AUTOIMMUNITY
 
P.T. 34; K.W. 0715015, 0745027, 0745070, 0710030
 
National Institute of Allergy and Infectious Diseases
 
Letter of Intent Receipt Date:      August 1, 1991
Application Receipt Date:           November 13, 1991
 
BACKGROUND INFORMATION
 
The Autoimmunity Section of the Division of Allergy, Immunology and
Transplantation (DAIT) of the National Institute of Allergy and
Infectious Diseases (NIAID) supports research aimed at elucidating the
causes and mechanisms of tolerance to potential allergans and to
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) is intended to encourage and invite
the development of program project applications by 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 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, D.C. 20402-9325 (telephone 202-783-3238).
 
RESEARCH GOALS AND SCOPE
 
The major goals of these program projects are:  increased understanding
of the 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.
 
NIAID is seeking broad and innovative applications that address all
aspects of the immune responses related to self reactivity and may
include studies concerned with relevant areas of genetics, cell and
molecular biology, biochemistry, physiology, microbiology, pathology,
and pharmacology.  Of special interest to NIAID are program projects
that emphasize new ideas, novel approaches, and state-of-the-art
technology in basic research that elucidate pathogenetic mechanisms and
that show 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, NIAID encourages 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.
 
Protocols 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 recommended.
 
SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH
POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL
RESEARCH STUDY POPULATIONS
 
NIH and ADAMHA policy is that applicants for NIH/ADAMHA clinical
research grants and cooperative agreements will be required to 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 should 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 should 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 Section 2, A-D of the Research Plan AND
summarized in Section 2, E, Human Subjects.
 
Applicants/offerors 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, prevention
(and preventive strategies), diagnosis, or treatment of diseases,
disorders or conditions, including, but not limited to, clinical trials.
 
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, every effort
should be made 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 foreign awards, 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 United States' 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 policies.
 
MECHANISM OF SUPPORT
 
Program project (P01) grants are awarded to an institution on behalf of
a program director for the support of a broadly based,
multidisciplinary, long-term research program that has a specific major
goal or basic theme.  A program project generally involves the organized
efforts of groups of investigators who conduct research projects related
to the overall program goal.  The grant can provide support for the
projects and for certain basic resources shared by individuals in the
program project if sharing facilitates the total research effort.  Each
project supported under a program project grant is expected to
contribute to and be directly related to the common theme of the
program; the projects, under the direction of a Principal Investigator,
should demonstrate an essential element of unity and interdependence.
 
The application must clearly explain how the projected multidisciplinary
integrated program can be expected to accomplish the stated goal more
efficiently and effectively than could a series of independent
individual grant-supported studies.
 
Designation of a program director should be based upon accomplishment
and experience as a scientist, the ability to assume both the leadership
of the research group and the responsibility for scientific,
professional, and administrative functions, and the commitment of a
significant amount of his/her time to the project.  Each project in the
program must have a designated project leader with a demonstrable record
of accomplishment in clinical immunology, or one of the basic science
disciplines or clinical specialties relevant to the particular subject
of investigation.  However, the participation of one junior investigator
whose project is an integral part of the overall program, and whose work
would be closely related to that of the senior scientist leaders of the
other projects, is encouraged by the NIAID.
 
Support for a program project in autoimmune mechanisms in disease will
be limited to a maximum of four years.  Competing renewals may be
submitted in response to an RFA or as an unsolicited application after
consultation with appropriate NIAID staff.  Funding beyond the first and
subsequent years of the grant will be contingent upon satisfactory
progress during the preceding years and availability of funds.  In
Fiscal Year 1992 the NIAID plans to award at least two program project
grants submitted in response to this RFA and, depending on availability
of funds and scientific merit, more than two.  Budgetary requests should
be limited to no more than $500,000 direct costs.  Grant funds may be
utilized to support the research activities of scientific and
professional personnel, administration, consultation services, central
support services, equipment, supplies, travel, and publication costs.
Support for research-related costs of patient involvement and medical
care may be authorized.  Since the program cannot provide funds for new
construction, adequate physical facilities must be available for the
primary needs of the project.  However, moderate alterations or
renovations to enhance clinical or laboratory facilities may be allowed
if they are necessary to meet objectives of the proposed program.
 
ELIGIBILITY
 
ONLY DOMESTIC INSTITUTIONS ARE ELIGIBLE TO APPLY.  Applications may be
submitted by any domestic, public or private, nonprofit or profit-making
organizations.
 
REVIEW PROCEDURES AND CRITERIA
 
These are outlined in the NIAID Information Brochure on Program Project
and Center Grants that contains special instructions and information for
preparing multiproject applications for program project grants, review
procedures and criteria, and other important information.  Before
proceeding, the prospective applicant should first request a copy of
this brochure from:
 
Olivia T. Preble, Ph.D.
Chief, Microbiology & Immunology Review Section
National Institute of Allergy and Infectious Diseases
National Institute of Health
Westwood Building, Room 3A-10
Bethesda, MD  20892
Telephone:  (301) 496-8208
 
Applications will be examined by NIAID staff to determine administrative
and programmatic responsiveness to this RFA; those judged to be
non-responsive will be returned to the applicant without review.
 
Those applications that are complete and responsive may be subjected to
a triage by an NIAID peer review group before or during the scientific
review meeting to determine their scientific merit relative to other
applications received in response to this RFA.  The NIAID will withdraw
from competition those applications judged to be non-competitive for
award and will notify the applicant and institutional business official.
 
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,
during February or March 1992.  The second level of review will be
provided by the National Advisory Allergy and Infectious Disease Council
in May 1992.  July 1, 1992 will be the earliest starting date for
successful applicants.
 
METHOD OF APPLYING
 
The receipt date for applications will be November 13, 1991.
APPLICATIONS NOT RECEIVED AS A SINGLE PACKAGE FROM THE APPLICANT
ORGANIZATION BY NOVEMBER 13, 1991, OR THAT DO NOT CONFORM TO THE
INSTRUCTIONS CONTAINED IN FORM PHS 398 (rev.  10/88) APPLICATION KIT,
WILL BE JUDGED TO BE NON-RESPONSIVE AND WILL BE RETURNED TO THE
APPLICANT.
 
Use the research grant application form PHS 398 (rev.  10/88).  For
purposes of identification and processing, the words "PROGRAM PROJECTS
ON AUTOIMMUNITY" and RFA number AI-91-09 must be typed in item 2 on the
face page of the application.
 
THE RFA LABEL AVAILABLE IN THE 10/88 REVISION OF 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 YOUR APPLICATION SUCH THAT
IT MAY NOT REACH THE REVIEW COMMITTEE IN TIME FOR REVIEW.
 
In addition to following the format instructions contained in the
Information Brochure for the development of a program project grant
application, include the expanded material listed below:
 
  o  A brief overview of the intended program project as well its
     components;
 
  o  A description of available laboratory and clinical facilities
     available for use by the proposed project;
 
  o  Ongoing relevant research studies, identifying existing projects
     and sources of support;
 
  o  Past research by members of the proposed investigative group
     relevant to the proposal;
 
  o  Specific information on the institution's present patient load and
     projections for patient involvement in clinical investigations;
 
  o  The academic positions and major research interests of the program
     director and his/her professional staff who will be involved in the
     work of the program project;
 
  o  Collaborative arrangements with other laboratories and
     investigators and delineation of the role and manner of anticipated
     participation and interaction of the Principal Investigators,
     consultants, and collaborators;
 
  o  Justification for the use of the PO1 mechanism as opposed to
     submission of individual RO1 projects.
 
Application kits may be obtained from the institution's office of
sponsored research and from:
 
Office of Grants Inquires
Division of Research Grants
National Institutes of Health
Westwood Building, Room 449
Bethesda, MD 20892
 
Submit a signed, typewritten original of the application, including the
checklist, and four signed, exact, single-sided photocopies, in one
package to:
 
Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892
 
IN ADDITION mail two exact copies of the application and six copies of
the appendices directly to Dr. Olivia Preble at the address given above.
 
LETTER OF INTENT
 
Prospective applicants are asked to submit by August 1, 1991, a letter
of intent that includes a descriptive title of the overall proposed
research, the name of the Principal Investigator, and a list of the
names of key investigators and their institution(s).  The letter of
intent is requested in order to provide an indication of the number and
scope of applications to be reviewed so as to allow early preparations
for review, as well as to promote early interactions between applicants
and NIAID staff.  The letter of intent is not binding and does not
commit the sender to submit an application, nor is it a requirement for
submission of an application.  The letter of intent is to be directed to
Dr. Preble at the address given above.
 
In addition, it is highly recommended that the Chief of the Autoimmunity
Section be contacted in the early stages of preparation of the
application:
 
Susana A. Serrate-Sztein, M.D.
Chief, Autoimmunity Section
Division of Allergy, Immunology and Transplantation
National Institute of Allergy and Infectious Diseases
National Institutes of Health
Westwood Building, Room 755
Bethesda, MD  20892
Telephone:  (301) 496-7985
Telefax:  (301) 402-0175
 
INQUIRIES
 
Inquiries concerning the programmatic aspects of this RFA may be
addressed to Dr. Serrate-Sztein at the address given above.
 
Inquiries regarding the review of these applications should be addressed
to Dr. Preble at the address given above.
 
Inquiries regarding fiscal matters may be addressed to Mr. Carow:
 
Mr. Jeffrey Carow
Chief, Immunology Grants Management Section
GMB, DEA, NIAID, NIH
Westwood Building, Room 726
Bethesda, MD  20892
Telephone:  (301) 496-7075
 
This program is described in the Catalog of Federal Domestic Assistance
No. 93.855, Immunology, Allergic and Immunologic 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 Regulation 42 CFR
Part 74.  This program is not subject to the intergovernmental review
requirements of Executive Order 12372 or Health Systems Agency review.