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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