Full Text AI-94-021

ASTHMA, ALLERGIC AND IMMUNOLOGIC DISEASES COOPERATIVE CENTERS

NIH GUIDE, Volume 23, Number 16, April 29, 1994

RFA:  AI-94-021

P.T. 34

Keywords: 
  Asthma 
  Hypersensitivity 
  Immune System Disorders 


National Institute of Allergy and Infectious Diseases

Letter of Intent Receipt Date:  August 15, 1994
Application Receipt Date:  November 15, 1994

PURPOSE

The Division of Allergy, Immunology and Transplantation (DAIT),
National Institute of Allergy and Infectious Diseases (NIAID),
invites applications for Asthma, Allergic and Immunologic Diseases
Cooperative Research Centers (AAIDCRCs).  This program is designed to
support basic and clinical research on mechanisms of, intervention
in, and prevention of asthma, allergic, and immunologic diseases.
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
interventions for asthma, allergic, and/or immunologic diseases in
defined populations.

HEALTHY PEOPLE 2000

The Public Health Service 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, 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

The administrative and funding mechanism to be used to undertake this
program will be the Multiproject Cooperative Agreement (U19), an
"assistance" mechanism, rather than an "acquisition" mechanism, in
which substantial NIH scientific and/or programmatic involvement with
the awardee is anticipated during the performance of the activity.
Under the cooperative agreement, the NIH purpose is to support and/or
stimulate the recipient's activity by involvement in and otherwise
working jointly with the award recipient in a partner role, but it is
not to assume direction, prime responsibility, or a dominant role in
the activity.  Essential elements of the multiproject cooperative
agreement mechanism also include:  (1) a minimum of three
interrelated individual research projects organized around a central
theme; (2) collaborative efforts and interaction among independent
projects and their investigators to achieve a common goal; (3) a
single Principal Investigator who will be scientifically and
administratively responsible for the group effort; (4) a single
applicant institution that will be legally and financially
responsible for the use and disposition of funds awarded; and (5)
support provided, as necessary, for "Core" resources or facilities,
each of which is expected to be utilized by at least two research
projects in order to facilitate the research effort.  Details of the
responsibilities, relationships and governance of a study funded
under a cooperative agreement are discussed later in this document
under the section "Terms and Conditions of Award."

The total project period for applications submitted in response to
this RFA may not exceed four years.  Reissuance of this initiative in
future years is anticipated, but not certain. If by the beginning of
the last year of support, the NIAID has not announced intentions to
readvertise the RFA, incumbents who wish to recompete are strongly
encouraged to contact NIAID Program Staff concerning selection of an
appropriate research grant mechanism before reapplying.

FUNDS AVAILABLE

The estimated total funds (direct and indirect costs) available for
the first year of support for awards made under this RFA will be
$3,000,000.  In Fiscal Year 1995, the NIAID plans to fund
approximately four U19s.  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.  The
usual PHS policies governing grants administration and management
will apply.  Applications may not request budgets in excess of
$750,000 total direct and indirect costs in the first year or more
than four percent annual inflationary increases for future years.  An
application with a first year requested amount in excess of $750,000
total costs will require written approval by senior NIAID officials
via the program officer for acceptance of the application for
processing.

RESEARCH OBJECTIVES

Background

The Asthma and Allergy Branch of the NIAID Division of Allergy,
Immunology and Transplantation supports basic and clinical
research on mechanisms of hypersensitivity and inflammation and
its application to asthma and allergic diseases.  The Division's
Clinical Immunology Branch supports basic and clinical research on
humoral, cellular and molecular mechanisms of immune system
functions in health and disease and the application of this basic
biomedical knowledge to the diagnosis, treatment, and prevention of
immunologic disorders.  Recent advances in understanding the
etiology and pathogenesis of asthma, allergic, and immunologic
diseases present important opportunities to gain fundamental
knowledge and enhance the clinical application of that knowledge.

The NIAID's current AAIDCRC program supports eleven extramural
centers for research on asthma and allergic diseases and five
centers focusing on immunologic diseases.  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.
The major goals of the Program are to:  (1) advance understanding
of the etiology and pathogenic mechanisms of allergic and
immunologic diseases, and (2) apply 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.

Applicants must propose both a biomedical research component, with
a minimum of three projects, and a Demonstration and Education (D&E)
research component.  A review of proposed D&E research
components will be carried out only for those applications of which
the
biomedical research component is judged of significant scientific
merit.

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  basic pathophysiologic mechanisms of human asthma and/or allergic
diseases, such as the role of cytokines, T cell subsets and/or
adhesion molecules in asthmatic and allergic inflammation and IgE
responses;

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

o  strategies for, and mechanisms of, prevention of asthma, allergic
or immunologic diseases;

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

o  mechanisms of immunodermatologic diseases (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 the D&E Research Component

Applications must include a proposed D&E research project to design
and evaluate the effectiveness of interventions to ameliorate/prevent
disease and/or promote health in defined populations.  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.
Applications may not request budgets in excess of $75,000 in total
direct costs for proposed D&E research projects in the first year or
more than four percent inflationary increases for future years.

Examples of diseases, populations, and types of interventions of
interest include, but are not limited to, the following:

Diseases:

o  Asthma including both host and environmental factors;

o  Allergic Diseases:  allergic rhinitis, atopic dermatitis, contact
dermatitis, urticaria, food and drug allergies; and

o  Immunologic diseases:  autoimmune diseases, including systemic
lupus erythematosus, diabetes, and rheumatoid arthritis,
immunodeficiency diseases and chronic inflammatory disorders.

Defined Populations:

Although asthma, allergic and immunologic diseases afflict many
populations, particular interest is focused on populations that are
disproportionately affected by these disorders, including children;
the elderly; women; minorities; as well as urban and rural
populations.

Types of Interventions:  A broad range of interventions may be
proposed for testing, including medical, behavioral, environmental,
and educational.  A variety of settings may be considered, including
school-based, clinic-based, and community-based.  Interventions may
be targeted to patients, their families, health care providers,
health care institutions, and/or the community.

NOTE:  EFFICACY STUDIES OF SPECIFIC DRUGS/TREATMENTS ARE NOT
ENCOMPASSED UNDER THE D&E COMPONENT OF THIS RFA.

SPECIAL REQUIREMENTS

A.  Study Organization

1.  Steering Committee

A Steering Committee will be established to serve as the main
governing body of the D&E research projects.  At a minimum, the
Steering Committee will be composed of the AAIDCRC Directors, the D&E
Research Project Leaders, and the NIAID Scientific Coordinator.  The
Committee will meet annually and the Chairperson will be selected by
the Steering Committee from among the non-Federal members during the
first meeting of the Committee, to be convened by the NIAID
Scientific Coordinator.  The Committee has primary responsibility for
selecting the D&E research projects to be implemented, facilitating
the conduct and monitoring of the D&E research projects, reviewing
progress and results on an annual basis, and providing technical
guidance on appropriate modifications in study design to enhance
validity and reliability.  D&E research projects will be selected
from among those judged to be scientifically meritorious by the
Initial Review Group.  In addition, analyses to be performed using
the collective data from multiple site D&E research projects will be
determined and directed by the Steering Committee.  Each AAIDCRC
Director and D&E Research Project Leader will be expected to
participate in other Steering Committee activities, e.g., conference
calls, reviewing and commenting on various written materials, etc.

2.  Data Collection, Management and Coordination

Each awardee will be responsible for the collection, management and
quality assurance of study data in accordance with the requirements
and specifications of the D&E research project.  In those instances
involving more than one AAIDCRC participating in the same D&E
research project, AAIDCRC Directors and D&E Project Leaders will work
collaboratively to ensure uniformity and adherence to study design,
as well as in the analysis of the collective data from all
participating AAIDCRCs.  The NIAID Scientific Coordinator will
provide assistance in coordinating such necessary collaborative
activities and in facilitating the sharing of data and other types of
information for multiple site projects.

B.  Minimum AAIDCRC Requirements

To promote the development of a multiproject collaborative program
among the award recipients, the following requirements are to be
addressed by each applicant.

1.  The applicant must include a description of:  (a) the central
scientific theme of the biomedical research component and the extent
to which the theme serves as a unifying, well-defined goal or problem
area of research; (b) a minimum of three proposed research projects,
representing several scientific disciplines, for basic and clinical
investigations of asthma, allergic and/or immunologic diseases; (c)
how and the extent to which each proposed research project
contributes to the central scientific theme and results in a greater
contribution to the overall goals than if each project were pursued
independently; and (d) the capacity of each proposed project to stand
on its own independent scientific merit, as well as complement the
other projects.

2.  The applicant must include a proposed D&E research project to
evaluate the effectiveness of interventions for asthma, allergic
and/or immunologic diseases in defined populations, including
descriptions of:  (a) the scientific basis of the proposed research
and the hypotheses to be tested; (b) the research design, sample size
needed, and procedures for sample selection, including a detailed
description of the study population chosen in terms of age, gender,
race, socioeconomic status, education, location, and risk factors and
documentation of the availability of this group; (c) plans for, and
documented experience in, recruitment and maintenance of study
populations; (d) proposed interventions in sufficient detail for
replication and methods of monitoring the quality, consistency and
impact of interventions; (e) proposed measurement instruments and
their reliability and validity; (f) proposed data management and
analysis methods; and (g) the significance of the proposed research
for amelioration/prevention of disease, as well as health promotion,
and the implications of study results for linkages to the health care
delivery system, health personnel, clinical practice and health care
costs.

Award of the U19 does not imply that the proposed D&E research
project will be implemented.  The actual D&E research projects to be
undertaken by the AAIDCRCs will be selected by the Steering Committee
from among those judged to be scientifically meritorious by the
Initial Review Group; therefore, the final studies may not reflect
the D&E projects proposed by each awardee in response to this RFA.
All costs required for the proposed D&E research project must be
included in the application and must be fully justified.  These
include costs for patient recruitment and follow-up, laboratory
studies where appropriate, data collection, analysis and quality
assurance.  Requested budgets should also include travel to annual
meetings of the Steering Committee for the AAIDCRC Director and the
D&E Project Leader, to be held in the Bethesda, Maryland area.

3.  The applicant must name a single Principal Investigator who will
serve as AAIDCRC Director and who will have scientific responsibility
for the application as a whole, including all AAIDCRC-related
research activities.  The applicant must also provide documentation
that the proposed AAIDCRC Director is an established scientist in the
fields of 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.

4.  The applicant must name a Project Leader for each proposed
biomedical research project, as well as the D&E research project, who
will have overall responsibility for the design, implementation, and
day-to-day scientific management of these projects.  The applicant
must provide documentation that each proposed Project Leader is an
established investigator with the scientific expertise and experience
necessary to direct the proposed biomedical and D&E research
projects.

5.  The applicant must provide:  (a) a clear, concise plan in
narrative and diagrammatic form that depicts the interrelationships
among the members of the AAIDCRC, their relevant
expertise/experience, and the contribution of each to the fulfillment
of the objectives of this RFA; (b) an organizational chart of the
AAIDCRC showing the name, organization, and scientific discipline of
the AAIDCRC Director, Project Leaders and all key scientific,
technical and administrative personnel; (c) a mechanism for selecting
and replacing key professional or technical personnel; and (d) a plan
to ensure the maintenance of close cooperation and effective
communication among AAIDCRC members.

6.  The applicant must provide documentation of the sponsoring
institution's commitment to the AAIDCRC program, including agreement
that the AAIDCRC Director and D&E Project Leader will serve on the
Steering Committee and willingness to abide by the decisions of the
Steering Committee on specific D&E research projects selected for
implementation.  The applicant must also provide documentation of the
availability of personnel and facilities capable of performing and
supporting the administrative functions of the AAIDCRC and should
discuss the capability of the applicant organization to participate
and interact effectively in cooperative research projects.

7.  The applicant must provide evidence of institutional expertise
in, and collaboration/cooperation among, basic research and clinical
specialties associated with this application.

8.  The applicant must document of the willingness of AAIDCRC
Director and D&E Project Leader to participate in annual meetings and
should request funding for attendance at these meetings, which will
usually be held in Bethesda, Maryland.

9.  The applicant must include a written commitment to accept the
participation and assistance of NIAID staff in accordance with the
guidelines outlined under "Terms and Conditions of Award:  NIAID
Staff Responsibilities."

10.  Applicants from currently NIAID-supported cooperative research
centers in asthma, allergic and immunologic diseases should include a
concise report of progress under the current grant and the
relationship of the proposed projects to those previously funded.

C.  Terms and Conditions of Award

The following terms and conditions will be incorporated into the
award statement and provided to the Principal Investigator as well as
the institutional official at the time of award.

These special Terms of Award are in addition to, and not in lieu of,
otherwise applicable OMB administrative guidelines, HHS Grant
Administration Regulations at 45 CFR part 74 and 92, and other HHS,
PHS, and NIH Grant Administration policy statements.

The administrative and funding instrument used for this program is
the multiproject cooperative agreement (U19), an "assistance"
mechanism (rather than an "acquisition" mechanism), in which
substantial NIH scientific and/or programmatic involvement with the
awardee is anticipated during the performance of the activity.  Under
the cooperative agreement, the NIH purpose is to support and/or
stimulate the recipient's activity by involvement in and otherwise
working jointly with the award recipient in a partner role, but it is
not to assume direction, prime responsibility, or a dominant role in
the activity. Consistent with this concept, the dominant role and
prime responsibility for the activity resides with the awardees for
the project as a whole, although specific tasks and activities in
carrying out the research will be shared among the awardees and the
NIAID Scientific Coordinator.

1.  Awardee Rights and Responsibilities

Awardees will have primary responsibility for defining the research
objectives, approaches and details of the projects within the
guidelines of the RFA and for performing the scientific activity.
Awardees agree to accept close coordination, cooperation, and
participation of NIAID staff in all aspects of the scientific and
technical management of the D&E research projects.  Specifically,
awardees have primary responsibility as described below.

Steering Committee Membership and Meeting Participation

Each AAIDCRC Director and each D&E Research Project Leader will serve
as a member of the Steering Committee and will participate in all
scientific decisions.  Each AAIDCRC Director and D&E Research Project
Leader will be responsible for attending all Steering Committee
meetings, including not less than one meeting per year, and will be
expected to participate in all other Steering Committee activities,
e.g., conference calls, reviewing and commenting on various written
materials, etc.

D&E Research Project Selection and Conduct

The Steering Committee will be responsible for selecting the specific
D&E research projects to be carried out by the AAIDCRCs, for
facilitating and monitoring the projects selected, for reviewing
progress and results on an annual basis, and for providing technical
guidance on appropriate modifications to study design to enhance
validity and reliability.  The D&E research projects will be selected
from among those judged to be scientifically meritorious by the
Initial Review Group.  Each awardee will be expected to adhere to the
determinations of the Steering Committee with respect to the D&E
research projects to be carried out, the AAIDCRC sites to participate
in selected studies, as well as the technical guidance provided by
the Committee with respect to study design.  Awardees agree to accept
the coordination, cooperation and participation of the NIAID
Scientific Coordinator as a member of the Steering Committee and the
responsibilities and determinations of that Committee regarding the
scientific and technical management of the D&E research projects.

Data Collection, Management and Coordination

Each awardee will be responsible for the collection, management and
quality assurance of study data in accordance with the requirements
and specifications of the D&E research project.  In those instances
involving more than one AAIDCRC participating in the same D&E
research project, AAIDCRC Directors and D&E Research Project Leaders
will work collaboratively to ensure uniformity and adherence to study
design, as well as in the analysis of the collective data from all
participating AAIDCRCs.  All data will be available to all awardees
and specific analyses to be performed using the collective data from
multiple site D&E research projects will be determined by the
Steering Committee.  The awardees will retain custody of and have
primary rights to all data developed under these awards, subject to
Government rights of access consistent with HHS, PHS, and NIH
policies.

Monitoring D&E Study Progress

Each awardee will have primary responsibility for monitoring D&E
study progress, including enrollment of eligible study participants,
timely collection and quality of required data, and conscientious
observance of study requirements.  Awardees participating in multiple
site D&E research projects will work collaboratively to ensure
uniformity and adherence to study design, as well as in the analysis
of the collective data from all participating AAIDCRCs.  In addition,
the Steering Committee will establish mechanisms for assessing
performance of multiple site D&E research projects.

Publication and Presentation of Study Findings

Early publication of major findings is encouraged.  Publications and
oral presentations of work performed under this agreement will
require acknowledgement of both the AAIDCRCs and NIAID support.
Analyses to be performed using the collective data from multiple site
D&E research projects will be determined by the Steering Committee.
AAIDCRCs wishing to perform analyses of local data from multiple site
studies will inform the Steering Committee of any such analyses prior
to initiation in order to avoid duplication.  Review and approval by
the Steering Committee will be required for all analyses of
collective data prior to publication or presentation according to the
criteria that will be developed by the Committee.

2.  NIAID Staff Responsibilities

NIAID staff assistance will be provided by the NIAID Scientific
Coordinator.  The Chief of the Asthma and Allergy Branch, NIAID
Division of Allergy, Immunology and Transplantation, or his/her
designee, will serve as the NIAID Scientific Coordinator and as such
represent the NIAID in all activities involving NIAID staff
participation.  The NIAID Scientific Coordinator will have
substantial scientific/programmatic involvement during the conduct of
this activity through technical assistance, advice and coordination
above and beyond normal program stewardship for grants, as described
below.

Steering Committee Membership and Meeting Attendance

The NIAID Scientific Coordinator will serve as a member of the
Steering Committee, will attend all Steering Committee meetings, and
will participate in other Committee activities, e.g., conference
calls, reviewing and commenting on various written materials, etc.
The NIAID Scientific Coordinator will provide to the Steering
Committee information on relevant completed and ongoing
NIAID-sponsored projects to facilitate the Committee's review and
selection of D&E research projects, including information on study
design, intervention tools, and study populations, mechanisms for
assessing performance, monitoring progress and determining meaningful
analyses of collective data bases.

As a member of the Steering Committee, the NIAID Scientific
Coordinator will also participate in all scientific deliberations of
the Committee and will serve as a resource with respect to selection,
monitoring and evaluation of D&E

Assistance will also be provided by the NIAID Scientific Coordinator
with respect to organizing and documenting the results of Steering
Committee meetings and other Committee activities and disseminating
the results of all such activities, as well as the appropriate
exchange of research materials, among Committee members.

Monitoring D&E Study Progress

The NIAID Scientific Coordinator will provide assistance to the
Steering Committee in the development of mechanisms and procedures
for monitoring D&E study performance.  This includes the provision of
relevant information and materials from completed and ongoing
NIAID-support projects, as well as participation in periodic site
visits to review progress and compliance with study requirements.

Data Coordination and Management

As a member of the Steering Committee, the NIAID Scientific
Coordinator will participate in Committee deliberations regarding the
data collection, management, quality assurance and analysis,
facilitating these deliberations through the dissemination of
relevant tools, techniques, and other materials from completed and
ongoing NIAID-supported studies.

The Government, via the NIAID Scientific Coordinator, will have
access to data generated under this Multiproject Cooperative
Agreement and may periodically review the data and progress reports.
Information obtained from the data may be used by NIAID Staff for the
preparation of internal reports on the activities of the study.
However, awardees will retain custody of and have primary rights to
all data developed under these awards.

Publication and Presentation of Study Findings

The NIAID Scientific Coordinator may contribute, through review,
comment, analysis, and/or co-authorship, to reporting results of the
D&E research projects to the investigator community and other
interested scientific and lay organizations.  Co-authorship by the
NIAID Scientific Coordinator will be subject to approval in
accordance with NIH policies regarding staff authorship of
publications resulting from extramural awards.

Organizational Changes

Certain organizational changes require the prior written approval of
the NIAID Scientific Coordinator.  These include changes in AAIDCRC
Director and the Project Leaders for both the biomedical and the D&E
research projects.  A change in any key personnel identified on the
Notice of Grant Award must have the prior written approval of the
NIAID Grants Management Specialist in consultation with the NIAID
Scientific Coordinator.

Program Review

The NIAID Scientific Coordinator will review the progress of each
AAIDCRC through consideration of the annual reports, site visits, and
other written materials provided to the Steering Committee.  This
review may include, but is not limited to, compliance with study
protocol, meeting patient enrollment targets, adherence to uniform
data collection procedures, and the timeliness and quality of data
reporting.

3.  Collaborative Responsibilities

A Steering Committee, composed of the AAIDCRC Directors, the D&E
Research Project Leaders, and the NIAID Scientific Coordinator, will
be the main governing body for the D&E research components of this
program and will have primary responsibility for all scientific
decisions, including:  selecting D&E projects to be carried out;
determining appropriate AAIDCRCs for participation in selected D&E
research projects; monitoring study progress on an annual basis;
providing technical guidance on appropriate modifications to enhance
study reliability and validity; establishing procedures for assessing
performance of multiple site projects with respect to accrual, timely
submission and quality of data, and conscientious observance of study
requirements; determining analyses to be performed on the collective
data bases from multiple site projects; and publishing/presenting
study findings.  D&E research projects will be selected from among
those judged to be scientifically meritorious by the Initial Review
Group.  The Chairperson will be selected by the Steering Committee
from among the non-Federal members.

Awardees will be required to accept and implement the D&E research
projects selected by the Steering Committee and the procedures
approved by the Steering Committee.  D&E research projects will
proceed into the implementation stage only with the concurrence of
the awardees and the NIAID Scientific Coordinator.

4.  Arbitration

Any disagreement that may arise on scientific/programmatic matters
(within the scope of the award) between award recipients and the
NIAID may be brought to arbitration.  An arbitration panel will be
composed of three members -- one selected by the Steering Committee
(with the NIAID member not voting) or by the individual awardee in
the event of an individual disagreement, a second member selected by
the NIAID, and the third member with expertise in the relevant area
and selected by the two prior members 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

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN
SUBJECTS

It is the policy of the NIH that women and members of minority groups
and their subpopulations 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 new
provisions that are substantially different from the 1990 policies.

All investigators proposing research involving human subjects should
read the "NIH Guidelines For Inclusion of Women and Minorities as
Subjects in Clinical Research", which have been published in the
Federal Register of March 28, 1994 (FR 59 14508-14513), and reprinted
in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume
23, Number 11.

Investigators may obtain copies from these sources or from the
program staff or contact person listed below.  Program staff may also
provide additional relevant information concerning the policy.

LETTER OF INTENT

Prospective applicants are asked to submit, by August 15, 1994, a
letter of intent that includes a descriptive title of the overall
proposed research, the name, address and telephone number of the
AAIDCRC Director, the number and title of this RFA, a list of the
names of key investigators and their institution(s), and a
descriptive title of each proposed research project.  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.

APPLICATION PROCEDURES

In preparing the application, the applicant should bear in mind the
research objectives of this RFA.  Applications must be prepared using
the guidance and instructions provided in NIAID PROGRAM PROJECT
GRANTS AND MULTIPROJECT COOPERATIVE AGREEMENTS (rev. February 1994),
which may be requested from Program Staff listed under INQUIRIES.
Failure to follow these instructions may results in delays in review
or in an incomplete application.

Applications are to be submitted on the research grant application
form PHS 398 (rev. 9/91).  These application forms may be obtained
from most institutional offices of sponsored research and from the
Office of Grants Information, Division of Research Grants, National
Institutes of Health, Westwood Building, Room 449, Bethesda, MD
20892, telephone (301) 435-0714.  Applications must adhere to the
format and requirements specified in the PHS 398 application kit.
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, Allergic and Immunologic Diseases Cooperative
Research Centers" must be typed in.

Applications must address the requirements outlined in the section
"SPECIAL REQUIREMENTS:  Minimum AAIDCRC Requirements."

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

Applications must be received by November 15, 1994.

Applications that are not received by the receipt date 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 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-spaced photocopies, in
one package to;

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 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.

REVIEW CONSIDERATIONS

General Considerations

General review considerations are outlined in the NIAID
Information Brochure on Program Project Grants and Multiproject
Cooperative Agreements, which contains special instructions for
preparing multiproject applications for cooperative agreements.
It includes Review Procedures and Review Criteria for
multicomponent interdisciplinary projects and other important
information.  This Brochure and the RFA are available by
contacting NIAID staff listed in INQUIRIES below.

Review Method

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

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 will withdraw from competition those applications
judged to be non-competitive for award and will notify the Principal
Investigator and institutional business official.  Those application
that are non-competitive will receive an abbreviated Summary
Statement.  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.  Review, Council and award dates can be found in "Schedule"
below.

Review Criteria

The general criteria are those review criteria for multiproject,
interdisciplinary cooperative agreements as outlined in the NIAID
Information Brochure.  In addition, applicants are expected to
address the issues identified under SPECIAL REQUIREMENTS as well as
criteria specific to the objectives of this RFA.  These criteria
include:

1.  The scientific and technical merit and significance of the
application as a whole, as well as each proposed biomedical research
project, in terms of enhancing fundamental knowledge on mechanisms
of, intervention in, and prevention of asthma, allergic and/or
immunologic diseases and contributing to the clinical application of
such knowledge.

2.  The cohesiveness, multi-disciplinary and multifaceted scope of
the application and the coordination and interdependence of the
individual projects to the common theme; the capacity of each
proposed biomedical research project to contribute to the central
scientific theme and to result in a greater contribution to the
overall goals than if each project were pursued independently; and
the capacity of each proposed project to stand on its own independent
scientific merit, as well as complement the other projects.

3.  The scientific and technical merit of the proposed D&E research
project and its significance in terms of the potential for improving
and/or preventing asthma, allergic and/or immunologic diseases.

4.  The leadership abilities, scientific expertise and experience,
and administrative competence of the proposed AAIDCRC Director,
including experience in directing and coordinating multi-disciplinary
research programs in asthma, allergic and/or immunologic diseases and
commitment to devote sufficient time and effort to the program.

5.  The scientific expertise and experience of the proposed Project
Leaders and key technical personnel relevant to the objectives of the
RFA, including related completed and ongoing research, experience in
multi-disciplinary interrelated research projects, and commitment to
devote sufficient time and effort to the program.

6.  The availability of adequate patient populations for the proposed
D&E research project and for any proposed clinical studies, as well
as the capability and experience of the key personnel and the
sponsoring institution in enrollment and maintenance of study
populations relevant to the application.

7.  The sponsoring institution's commitment to the multiproject
cooperative program, including:  institutional expertise in, and
collaboration/cooperation among, basic and clinical specialties
required to carry out the proposed projects; support for membership
of the proposed AAIDCRC Director and D&E Project Leader on the
Steering Committee and willingness to abide by the scientific
decisions of that Committee with respect to D&E research projects to
be implemented; and willingness to accept the participation and
assistance of NIAID staff.

8.  Merit of the proposed plan for coordination, cooperation, and
communication among AAIDCRC members within the applicant institution.

9.  Adequacy of available laboratory and clinical facilities,
including the institution's present patient load and access to and
projections for patient involvement in clinical investigations.

AWARD CRITERIA

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, requests for the RFA,
and requests for the NIAID Information Brochure on Program Projects
and Multiproject Cooperative Agreements, to:

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

Howard B. Dickler, M.D.
Division of Allergy, Immunology, and Transplantation
National Institute of Allergy and Infectious Diseases
Solar Building, Room 4A19
6003 Executive Boulevard
Bethesda, MD  20892
Telephone:  (301) 496-7104
FAX:  (301) 402-2571

Direct inquiries regarding review issues, address the letter of
intent to, and mail two copies of the application and 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:

Ms. Louise Kreh
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Solar Building, Room 4B26
6003 Executive Boulevard
Bethesda, MD  20892
Telephone:  (301) 496-7075

Schedule

Letter of Intent Receipt Date:  August 15, 1994
Application Receipt Date:       November 15, 1994
Scientific Review Date:         February 1995
Advisory Council Date:          June 1995
Earliest Award Date:            August 1995

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic
Assistance, No. 93.855 - Immunology, Allergy and Transplantation
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.

The Public Health Service (PHS) strongly encourages all grant
recipients to provide a smoke-free workplace and promote the non-use
of all tobacco products.  This is consistent with the PHS mission to
protect and advance the physical and mental health of the american
people.

.

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