Full Text AI-92-07

ASTHMA AND ALLERGIC AND IMMUNOLOGIC DISEASES COOPERATIVE RESEARCH
CENTERS

NIH GUIDE, Volume 21, Number 26, July 17, 1992

RFA:  AI-92-07

P.T. 04

Keywords: 
  Asthma 
  Immunology 
  Biomedical Research, Multidiscipl 


National Institute of Allergy and Infectious Diseases

Letter of Intent Receipt Date:  August 28, 1992
Application Receipt Date:  November 10, 1992

PURPOSE

The purpose of the Asthma and Allergic and Immunologic Diseases
Cooperative Research Centers (AAIDCRC) program is to support basic and
clinical research on mechanisms of, intervention in, and prevention of
asthma, allergic and immunologic diseases.  The applications are to be
designed around a central scientific theme demonstrating relevance to
one or more diseases in these areas.  A minimum of three biomedical
research projects must be proposed, plus a Demonstration and Education
(D&E) research component to study asthma and allergic or immunologic
diseases in defined populations.  The National Institute of Allergy and
Infectious Diseases (NIAID) plans to continue its support of the
AAIDCRC program.  Reissuance of this initiative in future years is
anticipated but not certain.

HEALTHY PEOPLE 2000

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), Asthma and Allergic and Immunologic Diseases
Cooperative Research Centers, is related to the priority areas of
education and community-based programs, environmental health, diabetes
and chronic disabling conditions, 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 202-783-3238).

ELIGIBILITY REQUIREMENTS

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.  Foreign organizations are
not eligible to apply.  Applications from minority individuals and
women are encouraged.

MECHANISM OF SUPPORT

Awards will be made as cooperative agreements (U01s).  This is an
assistance relationship with substantial involvement of NIAID staff.
An AAIDCRC cooperative agreement is awarded to an institution on behalf
of a program director for support of a broadly based,
multi-disciplinary research program designed around a unifying theme.
The agreement supports individual projects and certain shared resources
that contribute to the total research effort.

NIAID staff involvement will comprise assistance to the awardees in
this cooperative research program.  An Executive Committee composed of
Principal Investigators of AAIDCRCs awarded as a result of this
announcement and principal investigators of asthma and allergic and
immunologic diseases centers awarded under earlier announcements will
be formed.  With the assistance of the NIAID Scientific Coordinator,
the Executive Committee will (1) identify those NIAID-supported D&E
research projects whose successful conduct would be enhanced by the
participation of AAIDCRCs as intervention test and evaluation sites;
(2) identify those peer-reviewed NIAID-supported multi-center clinical
studies whose successful implementation would be enhanced by the
AAIDCRCs as clinical sites; and (3) coordinate necessary exchange of
information and research materials through annual meetings of the
Executive Committee and Principal Investigators of D&E research
projects and other forms of exchange.

Cooperative agreement funds may provide support for scientific and
professional personnel, administration, consultation services, central
support services, equipment, supplies, travel, and other expenses
(e.g., purchased services, publication costs) in accordance with
applicable Federal and awardee institution policy requirements.
Cooperative agreement funds may also be authorized for patient care
costs that are consistent with the provisions described in the PHS
Grants Policy Statement (Revised October 1, 1990).  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 necessary to meet objectives of the
proposed program.

Duration of support of an AAIDCRC will be limited to a maximum of five
years.  At this time, the NIAID is administratively limiting the
duration of such grants to four years; this administrative limitation
may change in the future. Funding beyond the first and subsequent years
of the cooperative agreement will be contingent upon satisfactory
progress during the preceding years and availability of funds.  July 1,
1993 will be the earliest start date for successful applicants.  It is
the intent of the NIAID to continue this initiative as a cooperative
agreement after the four- or five-year term, subject to programmatic
need and the availability of funds.

Except as otherwise stated in this RFA, awards will be administered
under PHS grants policy as stated in the Public Health Service Grants
Policy Statement, DHHS Publication No. (OASH) 90-50,000, revised
October 1, 1990.

FUNDS AVAILABLE

The estimated total funds available for the first year of this program
will be $6,000,000.  Budget requests should be limited to total direct
costs of no more than $500,000 per annum.  In Fiscal Year 1993, the
NIAID plans to fund approximately eight AAIDCRCs.

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, 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.

RESEARCH OBJECTIVES

Background

The Asthma and Allergy Branch of the NIAID Division of Allergy,
Immunology and Transplantation (DAIT) of the National Institute of
Allergy and Infectious Diseases (NIAID) sponsors basic and clinical
research grants and contracts on mechanisms of hypersensitivity and
inflammation and its application to asthma and allergic diseases.  The
Clinical Immunology Branch of DAIT, NIAID supports basic and clinical
research grants and contracts on humoral, cellular and molecular
mechanisms of immune system functions in health and disease and the
application of this basic biomedical knowledge to immunologic disease.
Recent advances in understanding the etiology and pathogenesis of
asthma, allergic and immunologic diseases present important
opportunities to further fundamental knowledge and enhance its clinical
application to these diseases.

The NIAID currently supports nine extramural centers for research on
asthma and allergic diseases and six centers focusing on immunologic
diseases.  Through this RFA, NIAID is initiating the consolidation of
these two research center programs into a single, coordinated program
composed solely of cooperative agreements.  Institutions with NIAID
support for research centers in asthma and allergic diseases or
immunologic diseases expiring in FY 1993 or FY 1994 are eligible to
apply under this RFA for support commencing upon expiration of their
current award provided that:  (1) the new application contains all the
required elements of an AAIDCRC, and (2) the requested period of
support does not extend beyond June 30, 1998.  Thus, prospective
applicants whose current period of support extends to fiscal year 1994
may request only four years of support.

The purpose of the AAIDCRC program is to accelerate the development and
application of fundamental knowledge of the immune system through
support of investigations concerned with immune system mediated
disorders, i.e., allergic, immunologic, and related inflammatory
disorders.  Specific goals of the Program are:  1) advancing the
understanding of the etiology and pathogenetic mechanisms of allergic
and immunologic diseases, and 2) applying an expanded knowledge base to
the development of improved methods of diagnosis, treatment, and
prevention of a wide variety of allergic and immune system disorders.
It is important that applicants have a broad base of expertise in
asthma, allergic or other immunologic diseases.

Applicants must propose both a biomedical research component, with a
minimum of three projects, and a D&E research component.  A review of
proposed D&E components will be carried out only for those applications
whose biomedical research component is judged of significant and
substantial scientific merit.  Although applications must contain both
a biomedical research component and a D&E research component, NIAID may
choose to award only the biomedical research components if the proposed
D&E research component is judged insufficiently meritorious.

Scope of the Biomedical Research Component

Eligible topics for study relevant to asthma, allergic and immunologic
diseases may include, but are not limited to:

o  the basic pathophysiologic mechanisms of human allergy, such as the
role of cytokines and/or adhesion molecules in allergic inflammation
and IgE responses;

o  the identification, isolation and characterization of etiologic
agents of allergic and hypersensitivity reactions (e.g., airborne
allergens, drugs, industrial chemicals, foods and contact sensitizing
agents);

o  the pathophysiology, epidemiology, and genetics of allergic diseases
(including allergic rhinitis, asthma, and atopic dermatitis);

o  the pathophysiology of other hypersensitivity reactions (including
allergic bronchopulmonary aspergillosis, hypersensitivity pneumonitis,
food allergy and drug reactions);

o  immunodermatologic studies (many hypersensitivity and
immune-mediated inflammatory mechanisms are relevant to disorders of
the skin such as contact dermatitis, atopic dermatitis and urticaria);

o  genetic, cellular and molecular mechanisms of immune system
disorders including autoimmune diseases and immunodeficiency diseases,
but excluding AIDS;

o  application of immunotherapeutics to immune system disorders;

o  characterization of mechanisms of acute and chronic inflammation;

o  immunopathologic aspects of host defense and phagocytosis; and

o  normal and abnormal leukocyte and complement system functions.

NOTE:  STUDIES OF THE HUMAN IMMUNODEFICIENCY VIRUS (HIV), AIDS, AND
ASSOCIATED OPPORTUNISTIC INFECTIONS AND MALIGNANCIES ARE NOT
ENCOMPASSED UNDER THIS RFA.

Scope of D&E Research Component

Demonstration and education research involves testing the effectiveness
of interventions to promote health or prevent disease in defined
populations.  Each AAIDCRC is required to propose a D&E research
component.  Applicants may choose:

Option 1 - INDEPENDENT D&E RESEARCH PROJECT:  Propose conducting an
independent D&E research project on a topic of the applicants' choice
for a total annual direct cost not to exceed $75,000; or

Option 2 - PARTICIPATION AS INTERVENTION TEST SITES IN NIAID-SUPPORTED
D&E RESEARCH PROJECTS:  Demonstrate capability to participate in
NIAID-supported D&E research projects for a total annual direct cost
not to exceed $75,000.

Option 1:  INDEPENDENT D&E RESEARCH PROJECT

Independent D&E research projects should be designed to test the
effectiveness of interventions for asthma, allergic and/or immunologic
diseases in defined populations (particularly underserved populations).

An application for a D&E research project should address the following:

1.  Describe the significance of the proposed research for health
promotion and disease prevention.  Include implications of study
results for linkages to the health and health care delivery system,
health personnel, clinical management practice, and health care costs.

2.  Describe the scientific basis of the proposed research.  It is
expected that the appropriate theories and techniques from the
biomedical, social, and behavioral sciences will be applied to the
study.

3.  Define the hypotheses to be tested in the research study and the
dependent variable(s).

4.  Describe the research design, the sample size needed, and the
procedures for sample selection.  Graphs of the research design may be
helpful.  Provide a detailed description of the study population chosen
for the research including age, race, socioeconomic status, education,
location, and risk factors; document the availability of this group.
Include plans for, and document experience in, recruitment and
maintenance of the study population, any anticipated changes in the
composition of the study population, and plans for measuring the impact
of these changes on the study.

5.  Describe the intervention(s) to be used in sufficient detail for
replication and describe the methods for monitoring the quality and
consistency of the intervention(s).

6.  Identify the measurement instruments to be used in the study.  For
example, standardized instruments have been developed and tested in
educational and psychological assessments to measure knowledge,
attitudes, behavior patterns, coping skills, and behavioral change.
The reliability and validity of the instruments to be used in a study
need to be discussed. Clinical, laboratory, and physiological measures
and protocols that are to be used need to be described in detail.

7.  Describe the approaches for data management and methods for data
analysis.  Provide evidence of the adequacy of the statistical power of
the analyses proposed for detecting differences in the variables
measured.

As noted above, the total annual direct costs of an independent D&E
research project should not exceed $75,000.

Option 2 - PARTICIPATION AS INTERVENTION TEST SITES IN NIAID-SUPPORTED
D&E RESEARCH PROJECTS

The attainment both of the objectives of D&E research projects and of
improved methods for promoting health and preventing disease may be
facilitated and expedited by the participation of AAIDCRCs in D&E
research projects as intervention test and evaluation sites.
Determination of the efficacy of promising behavioral and
behavioral/medical interventions can be delayed or, on occasion,
precluded by inadequate study populations. AAIDCRC applicants who
choose not to propose independent D&E research studies may have the
professional expertise and patient populations who can contribute to
successful determinations of the utility of interventions.

AAIDCRC applicants who choose this option must demonstrate the capacity
to effectively participate in the implementation of NIAID D&E research
projects, as documented by the following:  (1) access to, and ability
to retain, potential study populations with asthma, allergic and/or
immunologic diseases, with special attention to minority populations
wherever possible; (2) appropriate medical, behavioral, and educational
expertise to conduct intervention projects; (3) an understanding of the
nature and magnitude of the problems addressed by D&E research
projects, including those medical, social, economic, environmental and
behavioral factors likely to be associated with increased mortality and
morbidity; and (4) commitment from the applicant institution to
participate in a cooperative D&E research project.

Ongoing NIAID D&E research projects include:

1.  The NIAID National Cooperative Inner-City Asthma study, launched in
1991, is being conducted at eight sites in seven cities nationwide.  It
is designed to determine those factors contributing to the rise in
asthma mortality and morbidity among inner-city children, and to design
and evaluate a comprehensive intervention strategy aimed at those
factors identified as critical.

2.  Other ongoing NIAID D&E (R18) research projects focus on assessing
the effectiveness of educational and health care delivery interventions
aimed at asthmatics of all ages, with emphasis on underserved
populations.  These include evaluations of:  (1) computerized learning
tools for educating children with asthma; (2) traditional patient
education techniques in conjunction with peak flow monitoring; (3)
interventions aimed at ameliorating the effects of environmental
irritants; and (4) methods to enhance the efficiency and effectiveness
of, as well as access to, health care services among underserved
populations.

Future NIAID D&E research projects could include projects supported
under this RFA (Option 1) and independent D&E research projects
stemming from advances in knowledge concerning appropriate medical,
behavioral, educational and health care delivery interventions.

For those applicants whose capabilities are found to be acceptable, the
AAIDCRC Executive Committee composed of Center Directors, with the
assistance of the NIAID Scientific Director, will review and select D&E
research project(s) for collaborative participation by AAIDCRCs and
will determine the specific scope of their participation.

Other

In addition to the requirements stated in the application PHS Form 398
(rev. 9/91) and the NIAID Information Brochure on Program Projects and
Center Grants, the application should included the following:

1.  Documentation that the proposed AAIDCRC Director is an established
scientist in asthma, allergic and/or immunologic diseases with the
ability to assume both leadership of the investigative group and
responsibility for scientific, professional, and administrative
functions.

2.  Documentation of the sponsoring institution's commitment to the
program.  This will include agreement that the AAIDCRC Director will
serve on the AAIDCRC Executive Committee and willingness to abide by
the decisions of the Executive Committee on specific cooperative
clinical and D&E research projects it has selected for cooperative
endeavors.

3.  Description of the scientific theme of the application and the
contribution of or direct relationship of each proposed project to the
common theme.

4.  Evidence of institutional expertise in, and
collaboration/cooperation among, basic research and clinical
specialties associated with this application.

5.  Willingness of AAIDCRC Directors and project leaders for
cooperative clinical and D&E research projects to participate in an
annual two-day meeting of the AAIDCRC Executive Committee of AAIDCRC
Directors, Directors of existing NIAID research centers in asthma,
allergic and immunologic diseases, and the NIAID Scientific
Coordinator.  Applicants should request funding for attendance at these
meetings, which will usually be held in Bethesda, Maryland.

SPECIAL REQUIREMENTS

Successful applicant(s) funded under this RFA will be supported through
cooperative agreements.  This type of funding mechanism is used when it
is desired to encourage investigator-initiated research projects in
areas of special importance to the NIAID and where programmatic
assistance and involvement by NIAID staff would be beneficial to attain
the desired research goals.

Under the cooperative agreement, a partnership relationship exists
between the awardee and the NIAID in which the applicant is responsive
to the requirements and conditions set forth in the RFA.  Assistance
via a cooperative agreement differs from the traditional research grant
in that, in addition to the usual programmatic and administrative
stewardship responsibilities, the awarding component anticipates
significant programmatic involvement in providing assistance and
coordination during performance of the project.

NIAID staff assistance will be provided by the NIAID Scientific
Coordinator and will include:

1.  Provision of information on ongoing relevant NIAID-sponsored
programs and technical support to the AAIDCRC Executive Committee.
These would facilitate the Committee's review of program plans and
progress and enhance its ability to identify and select clinical and/or
D&E research projects for collaborative efforts.

2.  Participation in the design, implementation and evaluation of the
D&E research projects.

3.  Participation in the design and evaluation of multi-center clinical
studies.

4.  Coordination and facilitation of exchange of research materials and
of information through meetings of the Executive Committee and other
forms of exchange.  Specifically, NIAID staff will organize,
participate in and document and disseminate the results of these
meetings to the participants.

In the cooperative agreement mechanism, the applicant defines the
research objectives and approaches in accord with his/her own interests
and perceptions of novel and exploitable approaches to the prevention
of allergic immunologic diseases and develops the details of the
research design following the guidance given in this RFA.  The
applicant is to plan and conduct the research stipulated in the
application and to ensure that the results obtained are analyzed and
published in a timely manner.  The data obtained will be the property
of the awardee.  However, the awardee must agree to accept
coordination, cooperation, and participation of the NIAID Scientific
Coordinator in accordance with the terms formally negotiated and
mutually agreed upon prior to the award.

The Chief of the Asthma and Allergy Branch, DAIT, or his/her designee,
will be the NIAID Scientific Coordinator (NSC), and as such will
represent the NIAID in all activities involving NIAID staff
participation.  The NSC will assist the investigators in research
planning, particularly to prevent duplication of effort with other
extramural projects, provide or facilitate the exchange of research
materials, and networking as appropriate.  The role of NIAID NSC will
be to facilitate and not to direct the activities.

The NIAID will establish an arbitration process to resolve any
difference of opinion between the awardee and the NIAID with regard to
programmatic decisions on scientific-technical matters.  An arbitration
panel, composed of one AAIDCRC designee, one NIAID designee, and a
third designee with expertise in the relevant area and chosen by the
other two, will be formed to review any scientific or programmatic
issue that is significantly restricting progress. While the decisions
of the Arbitration Panel are binding, these special arbitration
procedures will in no way affect the awardee's right to appeal an
adverse action in accordance with PHS regulations at 42 CFR Part 50,
subpart D, and HHS regulations at 45 CFR Part 16.

Cooperative agreements are subject to the administrative requirements
outlined in OMB circulars A-102 and A-110.  All pertinent HHS, PHS, and
NIH grant regulations, policies and procedures, with particular
emphasis on PHS regulations at 42 CFR Part 52 and HHS regulations at 45
CFR Part 74, are applicable.  These special terms and conditions
pertaining to the scope and nature of the interaction between the NIAID
and the investigators will be incorporated in the Notice of Grant
Award.  However, these terms will be in addition to, not in lieu of,
the customary programmatic and financial negotiations that occur in the
administration of cooperative agreements.

STUDY POPULATIONS

SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH
POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL
RESEARCH POPULATIONS

NIH and ADAMHA policy requires that applicants for NIH/ADAMHA 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 by
gender, race and ethnicity.  In addition, gender and racial/ethnic
issues must be addressed in developing a research design and sample
size appropriate for the scientific objectives of the study.  This
information must be included in the form PHS 398 in Sections 1-4 of the
Research Plan AND summarized in Section 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 the U.S. racial/ethnic
minority population (i.e., Native Americans, including American Indians
or Alaskan Natives; Asian/Pacific Islanders; Blacks; and Hispanics).
The rationale for studies on selected minority populations should be
provided.

For the purpose of this policy, clinical research is defined as 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. 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 the applicants.

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 reflected in the
priority score.

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.

LETTER OF INTENT

Prospective applicants are asked to submit by August 28, 1992, a letter
of intent that includes a descriptive title of the overall proposed
research, the name of the AAIDCRC Director and a list of the names of
key investigators and their institution(s), and a descriptive title of
each proposed research project.  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.  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 sent to:

Mark L. Rohrbaugh, Ph.D.
Scientific Review Administrator
Microbiology and Immunology Review Section
Scientific Review Branch
National Institute of Allergy and Infectious Diseases
Solar Building, Room 4C22
Bethesda, MD  20892
Telephone:  (301) 496-8424

APPLICATION PROCEDURES

Applications are to be submitted on the 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 "Asthma and Allergic and Immunologic
Diseases Cooperative Research Centers" must be typed in.

These forms may be obtained from most institutional sponsored research
offices and from the Office of Grants Inquiries, Division of Research
Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449,
Bethesda, MD  20892, telephone (301) 496-7441.

The receipt date for applications will be November 10, 1992.
APPLICATIONS WHICH ARE NOT RECEIVED AS A SINGLE PACKAGE FROM THE
APPLICANT ORGANIZATION BY November 10, 1992, OR WHICH DO NOT CONFORM TO
THE INSTRUCTIONS CONTAINED IN PHS 398 (rev. 9/91) APPLICATION KIT, WILL
BE JUDGED TO BE NON-RESPONSIVE AND WILL BE RETURNED TO THE APPLICANT.

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**

In addition, mail two exact copies of the application and six copies of
the appendices directly to Dr. Mark Rohrbaugh at the address given
above.

THE RFA LABEL AVAILABLE IN THE APPLICATION FORM 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.

In addition, it is highly recommended that the Chief of the Asthma and
Allergy Branch, DAIT, be contacted in the early stages of preparation
of the application:

Marshall Plaut, M.D.
Chief, Asthma and Allergy Branch
Division of Allergy, Immunology and Transplantation
National Institute of Allergy and Infectious Diseases
6003 Executive Boulevard, Room 4A23
Bethesda, MD  20892
Telephone:  (301) 496-8973
FAX:  (301) 402-2571

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 proposed
clinical research.  In such a case, a letter of agreement from either
the GCRC program director or Principal Investigator must be included
with the application.

REVIEW CONSIDERATIONS

General review considerations are outlined in the NIAID Information
Brochure on Program Projects, Centers and Cooperative Agreements, which
contains special instructions for preparing multiproject applications
for  ooperative agreements.  It includes Review Procedures and Review
Criteria for multicomponent interdisciplinary projects and other
important information.  This Brochure and the RFA is available by
contacting Dr. Plaut at the address above.

Applications will be reviewed by NIAID staff to determine
administrative and programmatic responsiveness to this RFA; those
judged to be non-responsive or incomplete 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 the 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 applicants 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, in
March 1993.  The second level of review will be provided by the
National Advisory Allergy and Infectious Diseases Council in June 1993.

The general criteria are those review criteria for large,
multicomponent, interdisciplinary programs as outlined in the Brochure.
On addition to the scientific/technical merit criteria, the following
criteria specific to the objectives of this RFA are:

o  The proposed AAIDCRC director is an established scientist in the
field(s) of asthma and allergic and/or immunologic diseases with the
necessary experience to assume both leadership of the investigative
group and responsibility for scientific and administrative functions.
Each proposed project has a designated project leader with a
demonstrated record of scientific accomplishment in the basic science
disciplines or clinical specialties relevant to the proposed project.

o  The sponsoring institution's commitment to the program including
support of membership of the proposed Center Director on the AAIDCRC
Executive Committee and willingness to abide by the selections made by
the AAIDCRC Executive Committee on specific clinical and/or D&E
research projects for cooperative efforts.

o  Adequate laboratory and clinical facilities, including the
institution's present patient load and access to and projections for
patient involvement in clinical investigations.

o  Ongoing relevant research studies, including existing projects and
sources of support, and past research by members of the proposed
investigative group relevant to the application.

o  Institutional expertise in, and collaboration/cooperation among,
basic research and clinical specialties required to carry out the
proposed projects.

o  A clear, concise plan that describes the interrelationships among
the members of the AAIDCRC and the contribution of each to fulfillment
of AAIDCRC objectives.  This should include an organizational chart
showing the name, organization, and scientific discipline of the key
personnel.

o  The availability of adequate patient populations with asthma and
allergic and/or immunologic diseases for participation in clinical or
D&E research projects, and the availability of women and minorities
whenever possible.

AWARD CRITERIA

The earliest possible date of award is July 1993.

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.

INQUIRIES

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 Dr. Marshall Plaut at
the addresses given above.

Direct inquiries regarding review issues to Dr. Mark Rohrbaugh at the
address given above.

Direct inquiries regarding fiscal matters to:

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

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic
Assistance, No. 93.855 - Immunology, Allergic and Immunologic Diseases
Research.  Grants are awarded under the authority of the Public Health
Service Act, Section 301 (42 USC 241) and administered under PHS grants
policies and Federal Regulations, most specifically at 42 CFR Part 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.

.

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	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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