ASTHMA AND ALLERGIC DISEASES RESEARCH CENTERS
Release Date: April 3, 2000
RFA: AI-00-012
National Institute of Allergy and Infectious Diseases
National Institute of Environmental Health Sciences
Letter of Intent Receipt Date: November 8, 2000
Application Receipt Date: January 8, 2001
APPLICATIONS IN RESPONSE TO THIS REQUEST FOR APPLICATIONS (RFA) MUST BE
PREPARED USING A MULTI-PROJECT GRANT APPLICATION FORMAT; SPECIFIC
INSTRUCTIONS FOR COMPLETING THE APPLICATION ARE IN AN NIAID BROCHURE
ENTITLED "INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT AWARDS.
PURPOSE
The National Institute of Allergy and Infectious Diseases (NIAID), and
the National Institute of Environmental Health Sciences (NIEHS), the
National Institutes of Health (NIH), invite applications for Asthma and
Allergic Diseases Research Centers (AADRCs). This program is designed to
support basic and clinical research on mechanisms of, and diagnosis,
treatment and prevention of, asthma and allergic diseases. Applications
are to be designed around a central scientific theme demonstrating
relevance to one or more of these diseases. A minimum of three
biomedical research projects must be proposed.
HEALTHY PEOPLE 2010
The Public Health Service (PHS) is committed to achieving the health
promotion and disease prevention objectives of "Healthy People 2010," a
PHS-led national activity for setting priority areas. This RFA, Asthma
and Allergic Diseases Research Centers (AADRC), is related to the
priority areas of environmental health, food and drug safety, diabetes
and chronic disabling diseases, and immunization and infectious
diseases. Potential applicants may obtain a copy of "Healthy People
2010" at http://www.health.gov/healthypeople.
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 mechanism of support will be the program project(P01) grant. This
type of award supports broadly based multidisciplinary research programs
that have a well-defined central research focus or objective. The
program project grant consists of a minimum of three interrelated
individual research projects that contribute to the program objective.
An important feature is that the interrelationships among the individual
scientifically meritorious projects will result in a greater
contribution to the overall program goals than if each project were
pursued individually. The award also can provide support for certain
common resources (cores). Such resources should be utilized by two or
more projects within the award.
Responsibility for the planning, direction, and execution of the
proposed projects will be solely that of the applicant. The total
project period may not exceed five years. At this time, the NIAID and
the NIEHS are administratively limiting the duration of P01 grants to
four years; this limitation may change in the future. The earliest
anticipated award date is September 1, 2001.
FUNDS AVAILABLE
The estimated total funds (direct and Facility and
Administrative)available for the first year of support for this RFA will
be $6,750,000. In fiscal year 2001, NIAID and NIEHS plan to make
approximately six to eight awards related to this RFA. This level of
support is dependent on the receipt of a sufficient number of
applications of high scientific merit. Funding in excess of $900,000 in
total (direct and F&A) costs may be provided for highly meritorious
clinical research, of the type described below under Research
Objectives and Scope. Applicants requesting budgets in excess of
$900,000 in total costs in the first year must obtain approval from the
Program Contact listed in "INQUIRIES" prior to submission.
The usual NIH policies governing grants administration and management
will apply. Although this program is provided for in the financial
plans of the NIAID and the NIEHS, 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 and the NIEHS have not determined
whether or how this solicitation will be continued beyond the present
RFA.
RESEARCH OBJECTIVES
Background
The Asthma, Allergic and Immunologic Diseases Cooperative Research
Centers (AAIDCRC), jointly funded by NIAID and NIEHS, and NIAID Asthma
and Allergic Diseases Research Centers (AADRC) programs support basic
and clinical research on mechanisms of hypersensitivity and inflammation
and their application to asthma and allergic diseases, including
research on the immunologic mechanisms that induce and regulate these
diseases and the role of environmental agents in the etiology and
exacerbation of these diseases. Recent advances in understanding the
etiology and pathogenesis of asthma and allergic diseases present
important opportunities to gain fundamental knowledge and enhance its
clinical application. The most promising opportunities are in clinical
studies of patients with asthma and/or allergic diseases.
The AAIDCRC and AADRC programs currently support twelve extramural
centers for research on asthma and allergic diseases. The AADRC program
to be supported by this RFA is intended to replace the AAIDCRC program
by focusing on asthma and allergic diseases and immune and inflammatory
mechanisms related to these diseases. Autoimmunity, immune deficiency,
and Demonstration and Education Research Projects are not within the
scope of this RFA.
The purpose of the AADRC program is to accelerate the development and
application of fundamental knowledge of the immune system to
investigations of asthma and allergic diseases. The AADRCs provide an
infrastructure and a collaborative environment that make it possible to
investigate complex clinical problems. The major goals of the program
are to: 1) advance understanding of the etiology and pathogenic
mechanisms of asthma and allergic diseases, and 2) apply an expanded
knowledge base to the development of improved methods of diagnosis,
treatment, and prevention of asthma and allergic diseases.
Research Objectives and Scope
The goal of this RFA is to support multidisciplinary research programs
focused on studies of immunologic and other mechanisms underlying human
asthma and allergic diseases. NIEHS support will be provided for
research centers and/or subprojects focused on basic, pre-clinical and
clinical research on the role of environmental factors in disease onset,
progression and severity. Applications must propose a minimum of three
research projects organized around a central scientific theme. The
application should include an appropriate balance of basic and clinical
research, but with a major emphasis on human studies.
o Applications must include at least two research projects focused on
immunologic aspects of asthma and allergic diseases in man.
o At least one of these projects must involve clinical studies of
patients with asthma and allergic diseases. In vitro investigations of
blood, fluid and/or tissue samples will not be considered responsive to
this solicitation unless they are related to the patients clinical
status.
o Studies of relevant animal models may be included in the other
research projects.
o Applicants are strongly encouraged to include one or more
investigators who are not currently involved in studies of asthma and
allergic diseases.
o Applications may include investigators from more than one
institution, if that enhances the scientific strength of the
application.
o Provisions for a Data and Safety Monitoring Board should be included
if indicated by the scope of the proposed research.
The scientific scope of this program encompasses immunologically
mediated inflammation and the role of innate and adaptive immunity as
they pertain to asthma and allergic diseases. Preference for funding
will be given to research in the following scientific areas:
o Developmental Immunobiology of Asthma and Allergic Diseases -
evaluating events in the perinatal period, infancy and childhood,
including exposure to indoor allergens and other environmental agents
that modulate IgE and other immune responses relevant to these diseases;
o Defining Asthma Phenotypes - characterizing the expression of asthma
in relation to underlying mechanisms which distinguish distinct subsets
of asthmatic patients;
o Translational Research - from animal models to humans, particularly
focused on new immune therapies for asthma and allergic diseases,
including studies which are proof of concept in man.
On February 24, 2000, NIAID announced its expanded policies on
MONITORING OF CLINICAL TRIALS AND STUDIES in the NIH Guide at:
http://grants.nih.gov/grants/guide/notice-files/NOT-AI-00-003.html.
Applications and awards with component clinical trials and studies must
adhere to these policies including the terms and conditions of award;
see http://www.niaid.nih.gov/ncn/pdf/clinterm.pdf
Special Requirements
The NIAID and NIEHS will sponsor Asthma Research Centers meetings to
encourage exchange of information among investigators. The budget of the
application should include travel funds for a two-day meeting every
other year, most likely to be held in Bethesda, Maryland. Applicants
should also include a statement in their applications indicating their
willingness to participate in these meetings.
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, compelling rationale, and justification are provided
that inclusion is inappropriate with respect to the health of the
subjects or the purpose of the research. This policy results from the
NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43).
All investigators proposing research involving human subjects should
read the "NIH Guidelines for Inclusion of Women and Minorities as
Subjects in Clinical Research", published in the Federal Register of
March 28, 1994 (FR 59 14508-14513) and the NIH Guide for Grants and
Contracts, Vol. 23, No. 11, March 18, 1994 which is available on the web
at: http://grants.nih.gov/grants/guide/notice-files/not94-100.html.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN
SUBJECTS:
It is the policy of NIH that children (i.e., individuals under the age
of 21) must be included in all human subjects research, conducted or
supported by the NIH, unless there are scientific and ethical reasons
not to include them. This policy applies to all initial (Type 1)
applications submitted for receipt dates after October 1, 1998.
All investigators proposing research involving human subjects should
read the "NIH Policy and Guidelines on the Inclusion of Children as
Participants in Research Involving Human Subjects" that was published in
the NIH Guide for Grants and Contracts, March 6, 1998, and which is
available at the following URL address:
http://grants.nih.gov/grants/guide/notice-files/not98-024.html.
Investigators may obtain copies from these sources or from the Program
Officer listed in INQUIRIES below who may also provide additional
relevant information concerning the policy.
URLS IN NIH GRANT APPLICATIONS OR APPENDICES
All applications and proposals for NIH funding must be self-contained
within specified page limitations. Unless otherwise specified in an NIH
solicitation, internet addresses (URLs) should not be used to provide
information necessary to the review because reviewers are under no
obligation to view the Internet sites. Reviewers are cautioned that
their anonymity may be compromised when they directly access an Internet
site.
LETTER OF INTENT
Prospective applicants are asked to submit 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 and NIEHS
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.
Madelon Halula at the address listed under INQUIRIES by the date stated
on the face page of this RFA.
APPLICATION PROCEDURES
Applicants for P01 grants must follow special application guidelines in
the NIAID Brochure entitled INSTRUCTIONS FOR APPLICATIONS FOR MULTI-
PROJECT AWARDS (April 1999); this brochure is available via the WWW at:
http://www.niaid.nih.gov/ncn/grants/multibron.htm
Research grant application form PHS 398 (rev. 4/98) is to be used in
applying for these grants. Application kits are available at most
institutional offices of sponsored research and from the Division of
Extramural Outreach and Information Resources, National Institutes of
Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910,
telephone (301) 710-0267, email: GrantsInfo@nih.gov. Applications are
also available on the World Wide Web at
http://grants.nih.gov/grants/forms.htm.
For purposes of identification and processing, item 2a on the face page
of the application must be marked "YES" and the RFA number "AI-00-012"
and the words " ASTHMA AND ALLERGIC DISEASES RESEARCH CENTERS " must be
typed in.
The RFA label and line 2 of the application should both indicate the RFA
number and title. The RFA label 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.
The sample RFA label available at:
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf
has been modified to allow for this change. Please note this is in pdf
format.
Applications must be received by the receipt date listed on the face
page of this RFA. 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. 4/98) Application Kit (as modified in, and
superseded by, the NIAID BROCHURE ENTITLED "INSTRUCTIONS FOR
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.
General Clinical Research Center (GCRC)
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 or NIEHS 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 (P01 or
Competing Supplement), including the checklist, and three signed, exact,
single-sided photocopies, in one package to:
Center for Scientific Review
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 P01 grant
application and/or competing supplement application and all five sets of
any appendix material must be sent to Dr. Madelon Halula at the address
listed under "INQUIRIES."
Concurrent submission of an 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 a traditional individual research project (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
Applicants for P01 grants must follow special application guidelines in
the NIAID Brochure entitled INSTRUCTIONS FOR APPLICATIONS FOR MULTI-
PROJECT AWARDS (April 1999); this brochure is available via the WWW at:
http://www.niaid.nih.gov/ncn/grants/multibron.htm
The brochure presents specific instructions for sections of the PHS 398
(rev. 4/98) application form that should be completed differently than
usual. For all other items in the application, follow the usual
instructions in the PHS 398.
REVIEW CONSIDERATIONS
Review Procedures
Upon receipt, applications will be reviewed for completeness by the NIH
Center for Scientific Review 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, a process
(triage) may be used by the initial review group in which applications
will be determined to be competitive or non-competitive based on their
scientific merit relative to other applications received in response to
the RFA.
Applications judged to be competitive will be discussed and be assigned
a priority score. Applications determined to be non-competitive will be
withdrawn from further consideration and the Principal Investigator and
the official signing for the applicant organization will be notified.
The second level of review will be provided by the National Advisory
Allergy and Infectious Diseases Council.
Review Criteria
The general criteria for P01 grant applications are presented in the
NIAID brochure entitled INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT
AWARDS (April 1999).
Schedule
Letter of Intent Receipt Date: November 8, 2000
Application Receipt Date: January 8,2001
Scientific Review Date: April, 2001
Advisory Council Date: June, 2001
Earliest Date of Award: September 1, 2001
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.
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 APPLICATIONS FOR
MULTI-PROJECT AWARDS" as well as inquiries regarding programmatic
(eligibility and research scope) issues, may be directed to:
NIAID
Kenneth Adams, Ph.D.
Chief, Asthma and Inflammation Section
Asthma, Allergy and Inflammation Branch
Division of Allergy, Immunology and Transplantation
National Institute of Allergy and Infectious Diseases
6700-B Rockledge, Room 5147
Bethesda, MD 20892-7640
Telephone: (301) 496-8973
FAX: (301) 402-0175
Email: kadams@niaid.nih.gov
NIEHS
George S. Malindzak, Jr. Ph.D.
Program Administrator
Organ and Systems Toxicology Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233
Research Triangle Park, NC 27709
Phone# (919) 541-3289
Fax# (919) 541-5064
Email: malindzak@niehs.nih.gov
Direct inquiries regarding preparation of the application and review
issues to:
Dr. Madelon Halula
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 2150, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892-7616
Telephone: (301)(496-2636)
FAX: (301)(402-2638)
Email: mh30x@nih.gov
Direct inquiries regarding fiscal matters to:
NIAID
Ms. Sharie Bernard
Grants Management Specialist
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room (insert), MSC-7614
6700-B Rockledge Drive
Bethesda, MD 20892-7614
Telephone: (301) 496-7075
FAX: (301) 480-3780
E-mail: sb34k@nih.gov
NIEHS
Jacqueline M. Russell
Grants Management Specialist
Grants Management Branch
National Institute of Environmental Health Sciences
P.O. Box 12233, EC-22
Research Triangle Park, NC 27709
(919)541 0751 Fax:(919) 541-2860
russell@niehs.nih.gov
AUTHORITY AND REGULATIONS
This program is described in the Catalogue of Federal Domestic
Assistance No. 93.855. Awards are made under authorization of Sections
301 and 405 of the Public Health Service Act, as amended (42 USC 241 and
284) and administered under NIH grants policies and Federal Regulations
42 CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to
the intergovernmental review requirements of Executive Order 12372 or
Health Systems Agency review.
The Public Health Service 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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