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) 435-0714, 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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