ASTHMA AND ALLERGIC DISEASES RESEARCH CENTERS Release Date: April 13, 1998 RFA: AI-98-005 P.T. National Institute of Allergy and Infectious Diseases Letter of Intent Receipt Date: August 17, 1998 Application Receipt Date: November 24, 1998 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), National Institutes of Health (NIH), invites applications for Asthma and Allergic Diseases Research Centers (AADRCs). This program is designed to support basic and clinical research on mechanisms of, and 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. Under this RFA, competitive supplements will also be supported, for clinical investigations of new tolerogenic and immunomodulatory approaches to prevent and treat asthma and/or allergic diseases. 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 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 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 20402-9325 (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 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 termed 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 is administratively limiting the duration of P01 grants to four years; this administrative limitation may change in the future. The earliest anticipated award date is September 1, 1999. FUNDS AVAILABLE The estimated total funds (direct and indirect) available for the first year of support for this RFA will be $3,000,000. In fiscal year 1999, the NIAID plans to make approximately four 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 requesting budgets in excess of $750,000 in total (direct and indirect) costs in the first year must obtain approval from the Program Contact listed under INQUIRIES, prior to submission. Limited Competition for Supplements. In addition, there may be an estimated total funds (direct and indirect) of $600,000 available for the first year of support for competitive supplements, to grants funded by this RFA or to grants which are already funded under the existing RFA for Asthma, Allergic and Immunologic Diseases Cooperative Research Centers (RFA AI-96-005). These supplements will be for a maximum of two years of support. In fiscal year 1999, the NIAID plans to make approximately one or two of these supplemental awards. This level of support is dependent on the receipt of a sufficient number of applications of high scientific merit. 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 Program Project Applications. 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 their application to the diagnosis, prevention and treatment of asthma and allergic diseases, including research on the immunologic mechanisms which induce and regulate these diseases. Recent advances in understanding the etiology and pathogenesis of asthma and allergic and immunologic diseases present important opportunities to gain fundamental knowledge and enhance its clinical application. The NIAID's current Asthma, Allergic and Immunologic Diseases Cooperative Research Centers (AAIDCRC) program supports ten extramural centers for research on asthma and allergic diseases and two centers focusing on immunologic 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 which 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. Competing Supplement Applications. Asthma and allergic diseases are excellent models for devising approaches to alter the human immune response because many of the important allergens have been identified, purified, cloned and expressed as biologically active recombinant proteins. Purified allergens and crude allergen extracts can be given safely via mucosal and cutaneous routes in humans. Approaches that combine non-antigen-specific methods (e.g., second signal blockade, cytokine modulation) and antigen-specific tolerance have not been studied and may be uniquely effective in these diseases. With these reagents, timing, dose, route and molecular form of the allergen can be tightly controlled. Although allergen immunotherapy has clinical efficacy, the value of immunotherapy, and its benefits and risks, are controversial because of several recent studies which demonstrate only modest or minimal beneficial effects of immunotherapy in asthma. One possible explanation is that conventional immunotherapy does not induce sufficient alteration in the human immune response to produce optimal clinical benefit. Several strategies to induce immune tolerance now appear promising in vitro and in animal models of allergic disease. For example, "DNA vaccines," comprised of plasmid DNA encoding recombinant allergens, induce long-lasting allergen-specific tolerance in mice. Research Objectives and Scope Program Project Applications. Applications must propose a minimum of three research projects. The goal of this RFA is to support multidisciplinary research programs focused on studies of human asthma and allergic diseases, including investigations of the immunologic and other mechanisms underlying these diseases. Projects that incorporate clinically relevant animal models may be included. At least one of the research projects must focus on human immunologic studies. Research topics of interest include, but are not limited to, the following: o the induction of T cell-mediated immune tolerance for asthma prevention and treatment; o Fc-gamma-RIIB and other receptors that mediate negative signaling in mast cells and other immune and inflammatory cells, thereby down-regulating allergic responses; o the molecular and cellular mechanisms by which viruses and other non- allergic stimuli cause airways inflammation in asthma; o identification and amelioration of the underlying genetic variants which predispose to asthma and allergic diseases; o delineation of the role of cytokines and chemokines, T cell subsets and/or adhesion molecules in human asthmatic and allergic inflammation and IgE responses; o definition of the immune mechanisms for the development of hypersensitivity diseases such as food allergy and drug reactions; and the identification of experimental approaches to block these allergic diseases and, at the same time, avoid the adverse reactions of standard immunotherapy; and o delineation of the role of particulates and other pollutants in stimulating immunologically mediated inflammation, including synergistic interactions with allergens and viruses. Competing Supplement Applications. This RFA will also support supplements, with a maximum of two years of support. Only those centers which have been funded under this RFA or under the existing RFA for Asthma, Allergic and Immunologic Diseases Cooperative Research Centers (RFA AI 96-005) are eligible to apply for these supplements. These supplements are for clinical studies for immunologically based interventions in asthma and/or allergic diseases. For further information, contact the Program Contact listed under INQUIRIES. The objective of the clinical research to be supported is to assess the safety, efficacy, mechanisms of action, and therapeutic effect of multiple approaches to modulate the human immune response and/or induce antigen-specific tolerance in asthma and/or allergic diseases, including, but not limited to, the following: o second signal blockade o cytokine modulation o DNA vaccines Applications for competitive supplements should include the following components: o A proposed protocol for evaluating the safety and efficacy of novel and promising tolerogenic and immunomodulatory interventions, including (1) the rationale for the patient population, (2) the statistical calculations and considerations in determining sample size, (3) the study design and the therapeutic approach(es) selected for study, and (4) an assessment of how the anticipated study results can be expected to contribute to improvements in clinical outcome; and o Proposed adjunct studies of underlying mechanisms of action of the therapeutic approaches proposed for evaluation. Applications may also include proposed studies of immune and/or surrogate markers of disease activity and/or responsiveness to therapy. Applications for clinical components may by submitted by single institutions or consortia of institutions. Applications integrating clinical components with one or more of the basic research components of the Program Project grant (under the present RFA) and/or of the Cooperative Research Centers grant (under RFA AI 96- 005) are encouraged. Provisions for a Data and Safety Monitoring Board should be included if indicated by the scope of the proposed research. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are provided that inclusion is inappropriate with respect to the health of the subjects of 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", which have been 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. NIH POLICY AND GUIDELINES ON THE 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 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 Contact person listed under INQUIRIES who may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by August 17, 1998, 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. The letter of intent should also state whether the applicants intend to apply for a competitive supplement for clinical investigation. APPLICATION PROCEDURES Program Project Applications must be submitted separately from Competing Supplement Applications. Program Project Applications. Applications are to be submitted on the standard research grant application form PHS 398 (rev. 5/95). Application kits are available at most institutional offices of sponsored research and may be obtained 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: asknih@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 "AI 98-005" and the words "ASTHMA AND ALLERGIC DISEASES RESEARCH CENTERS" must be typed in. Applicants for P01 grants must follow special application guidelines in the NIAID Brochure entitled INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT AWARDS (September 1997); this brochure is available from NIAID staff listed in INQUIRIES below and via the WWW at: http://www.niaid.nih.gov/ncn/grants/multibron.htm Applications must be received by November 24, 1998. 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 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. Competing Supplement Applications. Applications are to be submitted on the standard research grant application form PHS 398 (rev. 5/95). Application kits are available at most institutional offices of sponsored research and may be obtained from the Grants Information Office, Office of Extramural Outreach and Information, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301) 710-0267, email: asknih@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 "AI 98-005" and the words "AADRC Competing Supplement" must be typed in. Awardees under RFA AI 96-005 must include the grant number of their parent AAIDCRC grant. Applications must be received by November 24, 1998. 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 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 (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/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. Kevin Callahan 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 Program Project (P01) Applications. Applicants for P01 grants must follow special application guidelines in the NIAID Brochure entitled INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT AWARDS (September 1997); 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. 5/95) application form that should be completed differently than usual. For all other items in the application, follow the usual instructions on pages 5-20 of the PHS 398 booklet. Competing Supplement Applications. Applicants must use the specific instructions in the PHS 398 (rev. 5/95) application. 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 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 Program Project Applications. The general criteria for P01 grant applications are presented in the NIAID brochure entitled INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT AWARDS (September 1997). Competing Supplement Applications. The five criteria to be used in the evaluation of competing supplement applications are listed below. To put those criteria in context, the following information is contained in instructions to the peer reviewers. The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. The reviewers will comment on the following aspects of the application in their written critiques in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered by the reviewers in assigning the overall score weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have a major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. 1. Significance. Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? 2. Approach. Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? 3. Innovation. Does the project employ novel concepts, approaches or method? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? 4. Investigator. Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? 5. Environment. Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? The initial review group will also examine: the appropriateness of proposed project budget and duration; the adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research and plans for the recruitment and retention of subjects; adequacy of plans for including children as appropriate for the scientific goals of the research; the provisions for the protection of human and animal subjects; and the safety of the research environment. 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 issues, may be directed to: Marshall Plaut, M.D. Division of Allergy, Immunology and Transplantation National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, Room 4A25 Bethesda, MD 20892-7640 Telephone: (301) 496-8973 FAX: (301) 402-2571 Email: mp27s@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 6003 Executive Boulevard, Room 4C20 Bethesda, MD 20892-7610 Telephone: (301) 496-8424 FAX: (301) 402-2638 Email: kc92t@nih.gov Direct inquiries regarding fiscal matters to: Ms. Sharie Bernard Division of Extramural Activities National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, Room 4B32 Bethesda, MD 20892-7610 Telephone: (301) 496-7075 FAX: (301) 480-3780 Email: sb34k@nih.gov Schedule Letter of Intent Receipt Date: August 17, 1998 Application Receipt Date: November 24, 1998 Scientific Review Date: March 1999 Advisory Council Date: May 1999 Earliest Date of Award: September 1, 1999 AUTHORITY AND REGULATIONS This program is supported under authorization of the Public Health Service Act, Sec. 301 (c), Public Law 78-410, as amended. The Catalogue of Federal Domestic Assistance Citation is No. 93.855 - Immunology, Allergy, and Transplantation Research. Awards will be administered under PHS grants policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems 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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