Full Text AI-96-005
 
ASTHMA, ALLERGIC AND IMMUNOLOGIC DISEASES COOPERATIVE RESEARCH
CENTERS
 
NIH GUIDE, Volume 25, Number 18, June 7, 1996
 
RFA:  AI-96-005
 
P.T. 04

Keywords: 
  Asthma 
  Hypersensitivity 
  Immunology 

 
National Institute of Allergy and Infectious Diseases
 
Letter of Intent Receipt Date:  September 15, 1996
Application Receipt Date:  January 15, 1997
 
APPLICATIONS IN RESPONSE TO THIS REQUEST FOR APPLICATIONS (RFA) MUST
BE PREPARED USING A MODIFIED (ABBREVIATED) GRANT APPLICATION FORMAT;
SPECIFIC INSTRUCTIONS FOR COMPLETING THE APPLICATION ARE IN AN NIAID
BROCHURE ENTITLED "INSTRUCTIONS FOR ABBREVIATED APPLICATIONS FOR
MULTI-PROJECT AWARDS" (February 1996).
 
PURPOSE
 
The Division of Allergy, Immunology and Transplantation of the
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 in defined populations.
 
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 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 Summary Report:  Stock No.
017-001-00473-1) through the Superintendent of Documents, Government
Printing Office, Washington, DC 20402-0325 (telephone 202-512-1800).
 
ELIGIBILITY REQUIREMENTS
 
Research grant applications may be submitted by domestic for-profit
and non-profit organizations, public and private institutions, such
as universities, colleges, hospitals, laboratories, units of State
and local governments, and eligible agencies of the Federal
government.  Foreign organizations are not eligible to apply.
Racial/ethnic minority individuals, women, and persons with
disabilities are encouraged to apply as Principal Investigators.
 
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.
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 under the section "Terms and Conditions of Award."
 
The total project period for an application submitted in response to
this RFA may not exceed five years.  At present, the NIAID is
administratively limiting the duration of U19s to four years; this
administrative limitation may change in the future.  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) available for the
first year of support for this RFA will be $3,750,000.  In fiscal
year 1997, the NIAID plans to make approximately five awards related
to this RFA.  This level of support is dependent on the receipt of a
sufficient number of applications of high scientific merit.
Applications may not request budgets in excess of $750,000 in total
(direct and indirect) costs in the first year.  NIH is currently
limiting annual inflationary increases to no more than four percent
for future years.  The usual PHS policies governing grants
administration and management will apply.  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.
 
At this time, the NIAID has not determined whether or how this
solicitation will be continued beyond the present RFA.
 
RESEARCH OBJECTIVES
 
Background
 
The Asthma, Allergy and Inflammation 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 its
clinical application.
 
The NIAID's current AAIDCRC program supports ten 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.
 
Scope of the Biomedical Research Component
 
Eligible topics for study include, but are not limited to the
following:
 
o  basic pathophysiologic mechanisms of human asthma and other
allergic diseases, including the role of cytokines, T cell subsets
and/or adhesion molecules in asthmatic and allergic inflammation and
IgE responses;
 
o  pathophysiology of other hypersensitivity reactions (including
allergic bronchopulmonary aspergillosis, hypersensitivity
pneumonitis, food allergy, and drug reactions);
 
o  identification, isolation, and characterization of etiologic
agents of allergic and hypersensitivity reactions (e.g., airborne
allergens, drugs, industrial chemicals, latex, 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, preventing asthma, allergic,
and/or other immunologic diseases, including development of novel
immunotherapeutic approaches;
 
o  mechanisms of immunodermatologic diseases, including blistering
autoimmune diseases, contact dermatitis, atopic dermatitis and
urticaria;
 
o  genetic, cellular and molecular mechanisms of immune system
disorders including autoimmune diseases and immunodeficiency
diseases;
 
o  characterization of mechanisms of acute and chronic inflammation;
 
o  studies of the genetic and immunologic basis of normal and
impaired host defenses.
 
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 propose a D&E research project to evaluate the
effectiveness of interventions to ameliorate/prevent disease and/or
promote health in underserved populations.  D&E research projects
must be designed to test the effectiveness of interventions for
asthma in defined populations.  These studies should test the
effectiveness of components of an intervention protocol developed by
the NIAID-funded National Cooperative Inner-City Asthma Study
(1991-1995).
 
This intervention relies on the skills and resources of a trained
asthma counselor who conducts group and individual sessions with
members of the target population and their families.  These sessions
provide education and guidance intended to improve interactions
between patients and health care providers, improve compliance with
medical regimens, and eliminate or diminish exposure to allergens.
This intervention was recently shown to markedly reduce symptoms of
asthma, asthma-related hospitalizations, and health care costs
related to asthma in the target population of inner-city children.  A
detailed written description of this intervention protocol will be
sent to applicants upon request.
 
A key aim of this RFA is to determine to what extent the
accomplishments of the National Cooperative Inner-City Asthma Study
can be achieved with the more limited resources available through D&E
projects.  Thus, it is critical that D&E proposals test one or more
of the components of the National Cooperative Inner-City Asthma
Study, and that the D&E interventions of all successful AAIDCRC grant
applications, to be coordinated by the Steering Committee, provide
quantifiable and complementary information.
 
Under exceptional circumstances, applicants may wish to test an
intervention beyond the scope of that evaluated in the National
Cooperative Inner-City Asthma Study, or may wish to target study
populations other than underserved children living in urban areas.
Applications which propose alternative interventions (i.e.,
interventions not encompassed by the protocol used in the National
Cooperative Inner-City Asthma Study) must have written approval by
senior NIAID officials, via the program officer, before the
application can be accepted and processed.  To ensure compliance with
the above, all applicants are strongly encouraged to discuss their
D&E proposals with the program contact listed under INQUIRIES.
 
Applications should not request first year budgets in excess of
$75,000 in total direct costs for proposed D&E research projects or
more than four percent inflationary increases for future years.
 
Types of Interventions
 
Proposed D&E research projects should build upon the experience of
the National Cooperative Inner-City Asthma Study.  NIAID recognizes
that within individual communitites there may be differing
requirements; however, the overall goal is to test the effectiveness
of interventions based upon this experience. Although applicants may
test any of the interventions evaluated in the National Cooperative
Inner-City Asthma Study, it is recommended that proposed D&E research
projects test the effectiveness of the asthma counselor in a variety
of settings. Possible variables and outcomes to be studied include,
but are not limited to, the following:  (1) the frequency and
duration of intervention; (2) the persistence of specific measurable
outcomes after termination of counseling sessions; and (3)
effectiveness of interventions targeted to different patient
populations (e.g., children recruited from schools vs. clinics).
 
Defined Populations
 
The intervention should occur among populations that have been
studied successfully in the National Cooperative Inner-City Asthma
Study (predominantly urban, medically underserved children with
asthma).
 
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.  Since this RFA
requires that all AAIDCRCs participate in closely related D&E
research projects, 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 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 retention 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.  It is essential
that applicants document fully their ability to recruit and retain
the proposed study populations.
 
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, usually 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 assure 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.  Applications from currently supported AAIDCRCs should include a
concise report of progress under the current grant and the
relationship of the proposed projects to those previously funded.
 
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 HAS,
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;
facilitating and monitoring the projects selected; reviewing progress
and results on an annual basis; and 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
from each of these AAIDCRCs 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 and retention of eligible study
participants, timely collection and maintenance 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
 
Timely 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 Chief of the Asthma,
Allergy and Inflammation Branch, NIAID Division of Allergy,
Immunology and Transplantation, or his/her designee, who will serve
as the NIAID Scientific Coordinator.  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, study populations, and 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 research projects.
 
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 government and administrative 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 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 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.  The Chairperson will be selected by the Steering Committee
from among the non-Federal members.  The Steering Committee 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.
 
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 and will review any scientific or
programmatic issue that is significantly impeding progress.  One
member will be 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 will be selected by the
NIAID, and a third member with expertise in the relevant area will be
selected by the two prior members. 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
HAS 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 HAS, PHS,
and NIH grant regulations, policies and procedures, with particular
emphasis on PHS regulations at 42 CFR Part 52 and HAS 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.
 
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 sub-populations must be included in all NIH supported
biomedical and behavioral research projects involving human subjects,
unless a clear and compelling rationale and justification is provided
that inclusion is inappropriate with respect to the health of the
subjects or the purpose of the research.  This new policy results
from the NIH Revitalization Act of 1993 (Section 492B of Public Law
103-43) and supersedes and strengthens the previous policies
(Concerning the Inclusion of Women in Study Populations, and
Concerning the Inclusion of Minorities in Study Populations) which
have been in effect since 1990.  The new policy contains some 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 Dr.
Rotrosen (listed in INQUIRIES below) who may also provide additional
relevant information concerning the policy.
 
LETTER OF INTENT
 
Prospective applicants are asked to submit, by September 15, 1996, a
letter of intent that includes a descriptive title of the overall
proposed research, the name, address and telephone number of the
Principal Investigator, and the number and title of this RFA.
Although the letter of intent is not required, is not binding, does
not commit the sender to submit an application, and does not enter
into the review of subsequent applications, the information that it
contains allows NIAID staff to estimate the potential review workload
and to avoid conflict of interest in the review.  The letter of
intent is to be sent to Dr. Kevin Callahan at the address listed
under INQUIRIES.
 
APPLICATION PROCEDURES
 
NOTE:  SEE BROCHURE FOR SPECIAL INSTRUCTIONS FOR COMPLETION OF GRANT
APPLICATIONS IN RESPONSE TO THIS RFA.
 
Applications are to be submitted on the standard research grant
application form PHS 398 (rev. 5/95).  Applications kits are
available at most institutional offices of sponsored research and may
be obtained from the Office of Extramural Outreach and Information
Resources, National Institutes of Health, 6701 Rockledge Drive, MSC
7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email:
ASKNIH@odrockm1.od.nih.gov.  For purposes of identification and
processing, item 2 on the face page of the application must be marked
"YES" and the RFA number "(RFA AI 96-005)" and the words "Asthma,
Allergic, & Immunologic Diseases Cooperative Centers" must be typed
in.
 
Applications must be received by January 15, 1997.  Applications that
are not received as a single package on the receipt date or that do
not conform to the instructions contained in PHS 398 (rev. 5/95)
application kit (as modified in, and superseded by, the NIAID
BROCHURE ENTITLED "INSTRUCTIONS FOR ABBREVIATED APPLICATIONS FOR
MULTI-PROJECT AWARDS"), will be judged non-responsive and will be
returned to the applicant.  The RFA label available in the
application form PHS 398 must be affixed to the bottom of the face
page.  Failure to use this label could result in delayed processing
of the application such that it may not reach the review committee in
time for review.
 
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.
 
It is highly recommended that the appropriate NIAID program contact
be consulted before submitting the letter of intent and during the
early stages of preparation of the application.  (See program contact
under INQUIRIES).
 
Submit a signed, typewritten original of the application, including
the checklist, and three signed, exact, single-sided photocopies, in
one package to:
 
DIVISION OF RESEARCH GRANTS
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710
BETHESDA, MD  20892-7710
BETHESDA, MD  20817 (for express mail or courier service)
 
At the time of submission, two additional exact copies of the grant
application and all five sets of any appendix material must be sent
to Dr. Kevin Callahan at the address listed under INQUIRIES.
 
Concurrent submission of an research project grant (R01) and a
Component Project of a Multi-project Application:  Current NIH policy
permits a component research project of a multi-project grant
application to be concurrently submitted as an individual research
project grant (R01) application.  If, following review, both the
multi-project application and the R01 application are found to be in
the fundable range, the investigator must relinquish the R01 and will
not have the option to withdraw from the multi-project grant.  This
is an NIH policy intended to preserve the scientific integrity of a
multi-project grant, which may be seriously compromised if a strong
component project(s) is removed from the program.  Investigators
wishing to participate in a multi-project grant must be aware of this
policy before making a commitment to the Principal Investigator and
awarding institution.
 
Special Instructions For Completion of Applications in Response to
This RFA
 
A status report on NIH reinvention activities was presented in the
NIH Guide, Vol. 24, No. 40, November 24, 1995.  Two of these
activities are:  (1) the use of "Just-in-Time" grant applications;
and (2) modular budget requests and funding.  "Just-in-Time" and
"Modular Budgeting" along with special page limits on the research
plan are used for applications in response to this RFA.
 
JUST-IN-TIME GRANT APPLICATIONS.  The basic principle of just-in-time
is to simplify and reduce the administrative and paperwork burdens of
preparing an NIH grant application without compromising the initial
review group determination of scientific merit or reasonableness of
the proposed budget.  To that end, both less and less detailed
information is required in just-in-time applications.  Applications
in response to this RFA are to use the just-in-time" format.
 
MODULAR GRANTS.  Applications are submitted and/or awards made with
direct costs in modules (multiples) of a given amount ($25,000 for
this RFA), with work proposed within these incremental categories.
The model involves using pre-established funding levels for awards
and acknowledging that grantees can and do rebudget post-award.  This
process eliminates the need for many budget details, thereby
relieving administrative burdens on both NIH staff and grantee
organizations and simplifying cost management by NIH program staff.
 
RESEARCH PLAN PAGE LIMIT.   Sections A - D of the research plan are
limited to 20 pages each for:  (1) the overview of the proposed
program; (2) each research project; and (3) each core.
 
The NIAID brochure, "INSTRUCTIONS FOR ABBREVIATED APPLICATIONS FOR
MULTI-PROJECT AWARDS," contains specific instructions for sections of
the PHS 398 (rev. 5/95) application form that must be completed
differently than usual.  Some sections in the application are
modified and others should not be completed for submission of the
application, but will be requested if the application receives a
score in the fundable range.  For all other items in the application,
follow the usual instructions on pages 5-20 of the PHS 398 booklet.
 
REVIEW CONSIDERATIONS
 
Review Procedures
 
Upon receipt, applications will be reviewed for completeness by the
NIH Division of Research Grants (DRG) and for responsiveness by NIAID
staff.  Incomplete and/or non-responsive applications will be
returned to the applicant without further consideration.
 
Applications that are complete and responsive to the RFA will be
evaluated for scientific and technical merit by an appropriate peer
review group convened by the NIAID in accordance with the review
criteria stated below.  As part of the initial merit review, all
applications will receive a written critique and undergo a process in
which only those applications deemed to have the highest scientific
merit, generally the top half of applications under review, will be
discussed, assigned a priority score, and receive a second level
review by the appropriate National Advisory Allergy and Infectious
Diseases Council.
 
Review Criteria
 
The general criteria for U19 multiproject cooperative agreement
applications are presented in the NIAID BROCHURE.  Additional review
criteria specific to this RFA are:
 
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 in defined patient populations.
 
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 balance, and
the availability of funds.
 
Schedule
 
Letter of Intent Receipt Date:     September 15, 1996
Application Receipt Date:          January 15, 1997
Scientific Review Date:            June 1997
Advisory Council Date:             September 1997
Earliest Date of Award:            September 1997
 
INQUIRIES
 
Written and telephone inquiries concerning this RFA are encouraged.
The opportunity to clarify any issues or questions from potential
applicants is welcome.
 
Requests for the NIAID brochure "INSTRUCTIONS FOR ABBREVIATED
APPLICATIONS FOR MULTI-PROJECT AWARDS" as well as inquiries regarding
programmatic issues, may be directed to:
 
Daniel Rotrosen, M.D.
Division of Allergy, Immunology and Transplantation
National Institute of Allergy and Infectious Diseases
Solar Building, Room 4A24
6003 Executive Boulevard
Bethesda, MD  20892-7640
Telephone:  (301) 496-8974
FAX:  (301) 402-2571
Email:  dr17g@nih.gov
 
Howard B. Dickler, M.D.
Division of Allergy, Immunology and Transplantation
National Institute of Allergy and Infectious Diseases
Solar Building, Room 4A24
6003 Executive Boulevard
Bethesda, MD  20892-7640
Telephone:  (301) 496-7104
FAX:  (301) 402-2571
Email:  hd7e@nih.gov
 
Direct inquiries regarding preparation of the application and review
issues, and address the letter of intent to, and mail two copies of
the application and all five sets of appendices to:
 
Kevin Callahan, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Solar Building, Room 4C20
6003 Executive Boulevard
Bethesda, MD  20892-7640
Telephone:  (301)496-8424
FAX:  (301) 402-2638
Email:  kc92t@nih.gov
 
Direct inquiries regarding fiscal matters to:
 
Pamela Fleming
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Solar Building, Room 4B30
6003 Executive Boulevard
Bethesda, MD  20892-7610
Telephone:  (301) 496-7075
FAX: (301) 480-3780
Email:  pf49e@nih.gov
 
AUTHORITY AND REGULATIONS
 
This program is described in the Catalogue of Federal Domestic
Assistance Nos.
93.856 and 93.855.  Awards are made under authorization of the Public
Health Service Act, Title IV, Part A (Public Law 78-410, as amended
by Public Law 99-158, 42 USC 241 and 285) and administered under PHS
grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74.
This Program is not subject to the intergovernmental review
requirements of Executive Order 12372 or Health Systems Agency
review.
 
The PHS strongly encourages all grant and contract recipients to
provide a smoke-free workplace and promote the non-use of all tobacco
products.  In addition, Public Law 103-227, the Pro-Children Act of
1994, prohibits smoking in certain facilities (or in some cases, any
portion of a facility) in which regular or routine education,
library, day care, health care or early childhood development
services are provided to children.  This is consistent with the PHS
mission to protect and advance the physical and mental health of the
American people.
 
.

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