Full Text AI-96-005 ASTHMA, ALLERGIC AND IMMUNOLOGIC DISEASES COOPERATIVE RESEARCH CENTERS NIH GUIDE, Volume 25, Number 18, June 7, 1996 RFA: AI-96-005 P.T. 04 Keywords: Asthma Hypersensitivity Immunology National Institute of Allergy and Infectious Diseases Letter of Intent Receipt Date: September 15, 1996 Application Receipt Date: January 15, 1997 APPLICATIONS IN RESPONSE TO THIS REQUEST FOR APPLICATIONS (RFA) MUST BE PREPARED USING A MODIFIED (ABBREVIATED) GRANT APPLICATION FORMAT; SPECIFIC INSTRUCTIONS FOR COMPLETING THE APPLICATION ARE IN AN NIAID BROCHURE ENTITLED "INSTRUCTIONS FOR ABBREVIATED APPLICATIONS FOR MULTI-PROJECT AWARDS" (February 1996). PURPOSE The Division of Allergy, Immunology and Transplantation of the National Institute of Allergy and Infectious Diseases (NIAID), invites applications for Asthma, Allergic and Immunologic Diseases Cooperative Research Centers (AAIDCRCs). This program is designed to support basic and clinical research on mechanisms of, intervention in, and prevention of asthma, allergic and immunologic diseases. Applications are to be designed around a central scientific theme demonstrating relevance to one or more diseases in these areas. A minimum of three biomedical research projects must be proposed, plus a Demonstration and Education (D&E) research component to study interventions for asthma in defined populations. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Asthma, Allergic and Immunologic Diseases Cooperative Research Centers, is related to the priority areas of education and community-based programs, environmental health, diabetes and chronic disabling conditions, and immunization and infectious diseases. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-0325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Research grant applications may be submitted by domestic for-profit and non-profit organizations, public and private institutions, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Foreign organizations are not eligible to apply. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT The administrative and funding mechanism to be used to undertake this program will be the Multiproject Cooperative Agreement (U19), an "assistance" mechanism, rather than an "acquisition" mechanism. Under the cooperative agreement, the NIH purpose is to support and/or stimulate the recipient's activity by involvement in and otherwise working jointly with the award recipient in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Essential elements of the multiproject cooperative agreement mechanism also include: (1) a minimum of three interrelated individual research projects organized around a central theme; (2) collaborative efforts and interaction among independent projects and their investigators to achieve a common goal; (3) a single Principal Investigator who will be scientifically and administratively responsible for the group effort; (4) a single applicant institution that will be legally and financially responsible for the use and disposition of funds awarded; and (5) support provided, as necessary, for "core" resources or facilities, each of which is expected to be utilized by at least two research projects in order to facilitate the research effort. Details of the responsibilities, relationships and governance of a study funded under a cooperative agreement are discussed under the section "Terms and Conditions of Award." The total project period for an application submitted in response to this RFA may not exceed five years. At present, the NIAID is administratively limiting the duration of U19s to four years; this administrative limitation may change in the future. Reissuance of this initiative in future years is anticipated but not certain. If by the beginning of the last year of support, the NIAID has not announced intentions to readvertise the RFA, incumbents who wish to recompete are strongly encouraged to contact NIAID Program Staff concerning selection of an appropriate research grant mechanism before reapplying. FUNDS AVAILABLE The estimated total funds (direct and indirect) available for the first year of support for this RFA will be $3,750,000. In fiscal year 1997, the NIAID plans to make approximately five awards related to this RFA. This level of support is dependent on the receipt of a sufficient number of applications of high scientific merit. Applications may not request budgets in excess of $750,000 in total (direct and indirect) costs in the first year. NIH is currently limiting annual inflationary increases to no more than four percent for future years. The usual PHS policies governing grants administration and management will apply. Although this program is provided for in the financial plans of the NIAID, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. Funding beyond the first and subsequent years of the grant will be contingent upon satisfactory progress during the preceding years and availability of funds. At this time, the NIAID has not determined whether or how this solicitation will be continued beyond the present RFA. RESEARCH OBJECTIVES Background The Asthma, Allergy and Inflammation Branch of the NIAID Division of Allergy, Immunology and Transplantation supports basic and clinical research on mechanisms of hypersensitivity and inflammation and its application to asthma and allergic diseases. The Division's Clinical Immunology Branch supports basic and clinical research on humoral, cellular and molecular mechanisms of immune system functions in health and disease and the application of this basic biomedical knowledge to the diagnosis, treatment and prevention of immunologic disorders. Recent advances in understanding the etiology and pathogenesis of asthma, allergic and immunologic diseases present important opportunities to gain fundamental knowledge and enhance its clinical application. The NIAID's current AAIDCRC program supports ten extramural centers for research on asthma and allergic diseases and five centers focusing on immunologic diseases. The purpose of the AAIDCRC program is to accelerate the development and application of fundamental knowledge of the immune system through support of investigations concerned with immune system mediated disorders, i.e., allergic, immunologic, and related inflammatory disorders. The major goals of the program are to: 1) advance understanding of the etiology and pathogenic mechanisms of allergic and immunologic diseases, and 2) apply an expanded knowledge base to the development of improved methods of diagnosis, treatment, and prevention of a wide variety of allergic and immune system disorders. Applicants must propose both a biomedical research component, with a minimum of three projects, and a Demonstration and Education (D&E) research component. Scope of the Biomedical Research Component Eligible topics for study include, but are not limited to the following: o basic pathophysiologic mechanisms of human asthma and other allergic diseases, including the role of cytokines, T cell subsets and/or adhesion molecules in asthmatic and allergic inflammation and IgE responses; o pathophysiology of other hypersensitivity reactions (including allergic bronchopulmonary aspergillosis, hypersensitivity pneumonitis, food allergy, and drug reactions); o identification, isolation, and characterization of etiologic agents of allergic and hypersensitivity reactions (e.g., airborne allergens, drugs, industrial chemicals, latex, foods, and contact sensitizing agents); o epidemiology and genetics of allergic diseases (including allergic rhinitis, asthma, and atopic dermatitis); o strategies for, and mechanisms of, preventing asthma, allergic, and/or other immunologic diseases, including development of novel immunotherapeutic approaches; o mechanisms of immunodermatologic diseases, including blistering autoimmune diseases, contact dermatitis, atopic dermatitis and urticaria; o genetic, cellular and molecular mechanisms of immune system disorders including autoimmune diseases and immunodeficiency diseases; o characterization of mechanisms of acute and chronic inflammation; o studies of the genetic and immunologic basis of normal and impaired host defenses. NOTE: STUDIES OF THE HUMAN IMMUNODEFICIENCY VIRUS (HIV), AIDS, AND ASSOCIATED OPPORTUNISTIC INFECTIONS AND MALIGNANCIES ARE NOT ENCOMPASSED UNDER THIS RFA. Scope of the D&E Research Component Applications must propose a D&E research project to evaluate the effectiveness of interventions to ameliorate/prevent disease and/or promote health in underserved populations. D&E research projects must be designed to test the effectiveness of interventions for asthma in defined populations. These studies should test the effectiveness of components of an intervention protocol developed by the NIAID-funded National Cooperative Inner-City Asthma Study (1991-1995). This intervention relies on the skills and resources of a trained asthma counselor who conducts group and individual sessions with members of the target population and their families. These sessions provide education and guidance intended to improve interactions between patients and health care providers, improve compliance with medical regimens, and eliminate or diminish exposure to allergens. This intervention was recently shown to markedly reduce symptoms of asthma, asthma-related hospitalizations, and health care costs related to asthma in the target population of inner-city children. A detailed written description of this intervention protocol will be sent to applicants upon request. A key aim of this RFA is to determine to what extent the accomplishments of the National Cooperative Inner-City Asthma Study can be achieved with the more limited resources available through D&E projects. Thus, it is critical that D&E proposals test one or more of the components of the National Cooperative Inner-City Asthma Study, and that the D&E interventions of all successful AAIDCRC grant applications, to be coordinated by the Steering Committee, provide quantifiable and complementary information. Under exceptional circumstances, applicants may wish to test an intervention beyond the scope of that evaluated in the National Cooperative Inner-City Asthma Study, or may wish to target study populations other than underserved children living in urban areas. Applications which propose alternative interventions (i.e., interventions not encompassed by the protocol used in the National Cooperative Inner-City Asthma Study) must have written approval by senior NIAID officials, via the program officer, before the application can be accepted and processed. To ensure compliance with the above, all applicants are strongly encouraged to discuss their D&E proposals with the program contact listed under INQUIRIES. Applications should not request first year budgets in excess of $75,000 in total direct costs for proposed D&E research projects or more than four percent inflationary increases for future years. Types of Interventions Proposed D&E research projects should build upon the experience of the National Cooperative Inner-City Asthma Study. NIAID recognizes that within individual communitites there may be differing requirements; however, the overall goal is to test the effectiveness of interventions based upon this experience. Although applicants may test any of the interventions evaluated in the National Cooperative Inner-City Asthma Study, it is recommended that proposed D&E research projects test the effectiveness of the asthma counselor in a variety of settings. Possible variables and outcomes to be studied include, but are not limited to, the following: (1) the frequency and duration of intervention; (2) the persistence of specific measurable outcomes after termination of counseling sessions; and (3) effectiveness of interventions targeted to different patient populations (e.g., children recruited from schools vs. clinics). Defined Populations The intervention should occur among populations that have been studied successfully in the National Cooperative Inner-City Asthma Study (predominantly urban, medically underserved children with asthma). SPECIAL REQUIREMENTS A. Study Organization 1. Steering Committee A Steering Committee will be established to serve as the main governing body of the D&E research projects. At a minimum, the Steering Committee will be composed of the AAIDCRC Directors, the D&E Research Project Leaders, and the NIAID Scientific Coordinator. The Committee will meet annually and the Chairperson will be selected by the Steering Committee from among the non-Federal members during the first meeting of the Committee, to be convened by the NIAID Scientific Coordinator. The Committee has primary responsibility for selecting the D&E research projects to be implemented, facilitating the conduct and monitoring of the D&E research projects, reviewing progress and results on an annual basis, and providing technical guidance on appropriate modifications in study design to enhance validity and reliability. D&E research projects will be selected from among those judged to be scientifically meritorious by the Initial Review Group. In addition, analyses to be performed using the collective data from multiple site D&E research projects will be determined and directed by the Steering Committee. Each AAIDCRC Director and D&E Research Project Leader will be expected to participate in other Steering Committee activities, e.g., conference calls, reviewing and commenting on various written materials, etc. 2. Data Collection, Management and Coordination Each awardee will be responsible for the collection, management and quality assurance of study data in accordance with the requirements and specifications of the D&E research project. Since this RFA requires that all AAIDCRCs participate in closely related D&E research projects, AAIDCRC Directors and D&E Project Leaders will work collaboratively to ensure uniformity and adherence to study design, as well as in the analysis of the collective data from all participating AAIDCRCs. The NIAID Scientific Coordinator will provide assistance in coordinating such necessary collaborative activities and in facilitating the sharing of data and other types of information for multiple site projects. B. Minimum AAIDCRC Requirements To promote the development of a multiproject collaborative program among the award recipients, the following requirements are to be addressed by each applicant. 1. The applicant must include a description of: (a) the central scientific theme of the biomedical research component and the extent to which the theme serves as a unifying, well-defined goal or problem area of research; (b) a minimum of three proposed research projects, representing several scientific disciplines, for basic and clinical investigations of asthma, allergic and/or immunologic diseases; (c) how and the extent to which each proposed research project contributes to the central scientific theme and results in a greater contribution to the overall goals than if each project were pursued independently; and (d) the capacity of each proposed project to stand on its own independent scientific merit, as well as complement the other projects. 2. The applicant must include a proposed D&E research project to evaluate the effectiveness of interventions for asthma in defined populations, including descriptions of: (a) the scientific basis of the proposed research and the hypotheses to be tested; (b) the research design, sample size needed, and procedures for sample selection, including a detailed description of the study population chosen in terms of age, gender, race, socioeconomic status, education, location, and risk factors and documentation of the availability of this group; (c) plans for, and documented experience in, recruitment and retention of study populations; (d) proposed interventions in sufficient detail for replication and methods of monitoring the quality, consistency and impact of interventions; (e) proposed measurement instruments and their reliability and validity; (f) proposed data management and analysis methods; and (g) the significance of the proposed research for amelioration/prevention of disease, as well as health promotion, and the implications of study results for linkages to the health care delivery system, health personnel, clinical practice and health care costs. It is essential that applicants document fully their ability to recruit and retain the proposed study populations. Award of the U19 does not imply that the proposed D&E research project will be implemented. The actual D&E research projects to be undertaken by the AAIDCRCs will be selected by the Steering Committee from among those judged to be scientifically meritorious by the Initial Review Group; therefore, the final studies may not reflect the D&E projects proposed by each awardee in response to this RFA. All costs required for the proposed D&E research project must be included in the application and must be fully justified. These include costs for patient recruitment and follow-up, laboratory studies where appropriate, data collection, analysis and quality assurance. Requested budgets should also include travel to annual meetings of the Steering Committee for the AAIDCRC Director and the D&E Project Leader, usually to be held in the Bethesda, Maryland area. 3. The applicant must name a single Principal Investigator who will serve as AAIDCRC Director and who will have scientific responsibility for the application as a whole, including all AAIDCRC-related research activities. The applicant must also provide documentation that the proposed AAIDCRC Director is an established scientist in the fields of asthma, allergic and/or immunologic diseases with the ability to assume both leadership of the investigative group and responsibility for scientific, professional, and administrative functions. 4. The applicant must name a Project Leader for each proposed biomedical research project, as well as the D&E research project, who will have overall responsibility for the design, implementation, and day-to-day scientific management of these projects. The applicant must provide documentation that each proposed Project Leader is an established investigator with the scientific expertise and experience necessary to direct the proposed biomedical and D&E research projects. 5. The applicant must provide: (a) a clear, concise plan in narrative and diagrammatic form that depicts the interrelationships among the members of the AAIDCRC, their relevant expertise/experience, and the contribution of each to the fulfillment of the objectives of this RFA; (b) an organizational chart of the AAIDCRC showing the name, organization, and scientific discipline of the AAIDCRC Director, Project Leaders and all key scientific, technical and administrative personnel; (c) a mechanism for selecting and replacing key professional or technical personnel; and (d) a plan to assure the maintenance of close cooperation and effective communication among AAIDCRC members. 6. The applicant must provide documentation of the sponsoring institution's commitment to the AAIDCRC program, including agreement that the AAIDCRC Director and D&E Project Leader will serve on the Steering Committee and willingness to abide by the decisions of the Steering Committee on specific D&E research projects selected for implementation. The applicant must also provide documentation of the availability of personnel and facilities capable of performing and supporting the administrative functions of the AAIDCRC and should discuss the capability of the applicant organization to participate and interact effectively in cooperative research projects. 7. The applicant must provide evidence of institutional expertise in, and collaboration/cooperation among, basic research and clinical specialties associated with this application. 8. The applicant must document of the willingness of AAIDCRC Director and D&E Project Leader to participate in annual meetings and should request funding for attendance at these meetings, which will usually be held in Bethesda, Maryland. 9. The applicant must include a written commitment to accept the participation and assistance of NIAID staff in accordance with the guidelines outlined under "Terms and Conditions of Award: NIAID Staff Responsibilities." 10. Applications from currently supported AAIDCRCs should include a concise report of progress under the current grant and the relationship of the proposed projects to those previously funded. Terms and Conditions of Award The following terms and conditions will be incorporated into the award statement and provided to the Principal Investigator as well as the institutional official at the time of award. These special Terms of Award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS Grant Administration Regulations at 45 CFR part 74 and 92, and other HAS, PHS, and NIH Grant Administration policy statements. The administrative and funding instrument used for this program is the] multiproject cooperative agreement (U19), [an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during the performance of the activity. Under the cooperative agreement, the NIH purpose is to support and/or stimulate the recipient's activity by involvement in and otherwise working jointly with the award recipient in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Consistent with this concept, the dominant role and prime responsibility for the activity resides with the awardees for the project as a whole, although specific tasks and activities in carrying out the research will be shared among the awardees and the NIAID Scientific Coordinator. 1. Awardee Rights and Responsibilities Awardees will have primary responsibility for defining the research objectives, approaches and details of the projects within the guidelines of the RFA and for performing the scientific activity. Awardees agree to accept close coordination, cooperation, and participation of NIAID staff in all aspects of the scientific and technical management of the D&E research projects. Specifically, awardees have primary responsibility as described below. Steering Committee Membership and Meeting Participation Each AAIDCRC Director and each D&E Research Project Leader will serve as a member of the Steering Committee and will participate in all scientific decisions. Each AAIDCRC Director and D&E Research Project Leader will be responsible for attending all Steering Committee meetings, including not less than one meeting per year, and will be expected to participate in all other Steering Committee activities, e.g., conference calls, reviewing and commenting on various written materials, etc. D&E Research Project Selection and Conduct The Steering Committee will be responsible for: selecting the specific D&E research projects to be carried out by the AAIDCRCs; facilitating and monitoring the projects selected; reviewing progress and results on an annual basis; and providing technical guidance on appropriate modifications to study design to enhance validity and reliability. The D&E research projects will be selected from among those judged to be scientifically meritorious by the Initial Review Group. Each awardee will be expected to adhere to the determinations of the Steering Committee with respect to the D&E research projects to be carried out, the AAIDCRC sites to participate in selected studies, as well as the technical guidance provided by the Committee with respect to study design. Awardees agree to accept the coordination, cooperation and participation of the NIAID Scientific Coordinator as a member of the Steering Committee and the responsibilities and determinations of that Committee regarding the scientific and technical management of the D&E research projects. Data Collection, Management and Coordination Each awardee will be responsible for the collection, management and quality assurance of study data in accordance with the requirements and specifications of the D&E research project. In those instances involving more than one AAIDCRC participating in the same D&E research project, AAIDCRC Directors and D&E Research Project Leaders from each of these AAIDCRCs will work collaboratively to ensure uniformity and adherence to study design, as well as in the analysis of the collective data from all participating AAIDCRCs. All data will be available to all awardees and specific analyses to be performed using the collective data from multiple site D&E research projects will be determined by the Steering Committee. The awardees will retain custody of and have primary rights to all data developed under these awards, subject to Government rights of access consistent with HHS, PHS, and NIH policies. Monitoring D&E Study Progress Each awardee will have primary responsibility for monitoring D&E study progress, including enrollment and retention of eligible study participants, timely collection and maintenance of required data, and conscientious observance of study requirements. Awardees participating in multiple site D&E research projects will work collaboratively to ensure uniformity and adherence to study design, as well as in the analysis of the collective data from all participating AAIDCRCs. In addition, the Steering Committee will establish mechanisms for assessing performance of multiple site D&E research projects. Publication and Presentation of Study Findings Timely publication of major findings is encouraged. Publications and oral presentations of work performed under this agreement will require acknowledgement of both the AAIDCRCs and NIAID support. Analyses to be performed using the collective data from multiple site D&E research projects will be determined by the Steering Committee. AAIDCRCs wishing to perform analyses of local data from multiple site studies will inform the Steering Committee of any such analyses prior to initiation in order to avoid duplication. Review and approval by the Steering Committee will be required for all analyses of collective data prior to publication or presentation according to the criteria that will be developed by the Committee. 2. NIAID Staff Responsibilities NIAID staff assistance will be provided by the Chief of the Asthma, Allergy and Inflammation Branch, NIAID Division of Allergy, Immunology and Transplantation, or his/her designee, who will serve as the NIAID Scientific Coordinator. The NIAID Scientific Coordinator will have substantial scientific/programmatic involvement during the conduct of this activity through technical assistance, advice and coordination above and beyond normal program stewardship for grants, as described below. Steering Committee Membership and Meeting Attendance The NIAID Scientific Coordinator will serve as a member of the Steering Committee, will attend all Steering Committee meetings, and will participate in other Committee activities, e.g., conference calls, reviewing and commenting on various written materials, etc. The NIAID Scientific Coordinator will provide to the Steering Committee information on relevant completed and ongoing NIAID-sponsored projects to facilitate the Committee's review and selection of D&E research projects, including information on study design, intervention tools, study populations, and mechanisms for assessing performance, monitoring progress and determining meaningful analyses of collective data bases. As a member of the Steering Committee, the NIAID Scientific Coordinator will also participate in all scientific deliberations of the Committee and will serve as a resource with respect to selection, monitoring and evaluation of D&E research projects. Assistance will also be provided by the NIAID Scientific Coordinator with respect to organizing and documenting the results of Steering Committee meetings and other Committee activities and disseminating the results of all such activities, as well as the appropriate exchange of research materials among Committee members. Monitoring D&E Study Progress The NIAID Scientific Coordinator will provide assistance to the Steering Committee in the development of mechanisms and procedures for monitoring D&E study performance. This includes the provision of relevant information and materials from completed and ongoing NIAID-support projects, as well as participation in periodic site visits to review progress and compliance with study requirements. Data Coordination and Management As a member of the Steering Committee, the NIAID Scientific Coordinator will participate in Committee deliberations regarding the data collection, management, quality assurance and analysis, facilitating these deliberations through the dissemination of relevant tools, techniques, and other materials from completed and ongoing NIAID-supported studies. The Government, via the NIAID Scientific Coordinator, will have access to data generated under this Multiproject Cooperative Agreement and may periodically review the data and progress reports. Information obtained from the data may be used by NIAID Staff for the preparation of government and administrative reports on the activities of the study. However, awardees will retain custody of and have primary rights to all data developed under these awards. Publication and Presentation of Study Findings The NIAID Scientific Coordinator may contribute, through review, comment, analysis, and/or co-authorship, to reporting results of the D&E research projects to the investigator community and other interested scientific and lay organizations. Co-authorship by the NIAID Scientific Coordinator will be subject to approval in accordance with NIH policies regarding staff authorship of publications resulting from extramural awards. Organizational Changes Certain organizational changes require the prior written approval of the NIAID Scientific Coordinator. These include changes in AAIDCRC Director and the Project Leaders for both the biomedical and the D&E research projects. A change in any key personnel identified on the Notice of Award must have the prior written approval of the NIAID Grants Management Specialist in consultation with the NIAID Scientific Coordinator. Program Review The NIAID Scientific Coordinator will review the progress of each AAIDCRC through annual reports, site visits, and other written materials provided to the Steering Committee. This review may include, but is not limited to, compliance with study protocol, meeting patient enrollment targets, adherence to uniform data collection procedures, and the timeliness and quality of data reporting. 3. Collaborative Responsibilities A Steering Committee, composed of the AAIDCRC Directors, the D&E Research Project Leaders, and the NIAID Scientific Coordinator, will be the main governing body for the D&E research components of this program. The Chairperson will be selected by the Steering Committee from among the non-Federal members. The Steering Committee will have primary responsibility for all scientific decisions, including: selecting D&E projects to be carried out; determining appropriate AAIDCRCs for participation in selected D&E research projects; monitoring study progress on an annual basis; providing technical guidance on appropriate modifications to enhance study reliability and validity; establishing procedures for assessing performance of multiple site projects with respect to accrual, timely submission and quality of data, and conscientious observance of study requirements; determining analyses to be performed on the collective data bases from multiple site projects; and publishing/presenting study findings. Awardees will be required to accept and implement the D&E research projects selected by the Steering Committee and the procedures approved by the Steering Committee. D&E research projects will proceed into the implementation stage only with the concurrence of the awardees and the NIAID Scientific Coordinator. 4. Arbitration Any disagreement that may arise on scientific/programmatic matters (within the scope of the award) between award recipients and the NIAID may be brought to arbitration. An arbitration panel will be composed of three members and will review any scientific or programmatic issue that is significantly impeding progress. One member will be selected by the Steering Committee (with the NIAID member not voting) or by the individual awardee in the event of an individual disagreement, a second member will be selected by the NIAID, and a third member with expertise in the relevant area will be selected by the two prior members. While the decisions of the Arbitration Panel are binding, these special arbitration procedures will in no way affect the awardee's right to appeal an adverse action in accordance with PHS regulations at 42 CFR Part 50, subpart D, and HAS regulations at 45 CFR Part 16. Cooperative agreements are subject to the administrative requirements outlined in OMB circulars A-102 and A-110. All pertinent HAS, PHS, and NIH grant regulations, policies and procedures, with particular emphasis on PHS regulations at 42 CFR Part 52 and HAS regulations at 45 CFR Part 74, are applicable. These special terms and conditions pertaining to the scope and nature of the interaction between the NIAID and the investigators will be incorporated in the Notice of Grant Award. However, these terms will be in addition to, not in lieu of, the customary programmatic and financial negotiations that occur in the administration of cooperative agreements. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations) which have been in effect since 1990. The new policy contains some new provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research", which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513), and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11. Investigators may obtain copies from these sources or from Dr. Rotrosen (listed in INQUIRIES below) who may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by September 15, 1996, a letter of intent that includes a descriptive title of the overall proposed research, the name, address and telephone number of the Principal Investigator, and the number and title of this RFA. Although the letter of intent is not required, is not binding, does not commit the sender to submit an application, and does not enter into the review of subsequent applications, the information that it contains allows NIAID staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to Dr. Kevin Callahan at the address listed under INQUIRIES. APPLICATION PROCEDURES NOTE: SEE BROCHURE FOR SPECIAL INSTRUCTIONS FOR COMPLETION OF GRANT APPLICATIONS IN RESPONSE TO THIS RFA. Applications are to be submitted on the standard research grant application form PHS 398 (rev. 5/95). Applications kits are available at most institutional offices of sponsored research and may be obtained from the Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267, email: ASKNIH@odrockm1.od.nih.gov. For purposes of identification and processing, item 2 on the face page of the application must be marked "YES" and the RFA number "(RFA AI 96-005)" and the words "Asthma, Allergic, & Immunologic Diseases Cooperative Centers" must be typed in. Applications must be received by January 15, 1997. Applications that are not received as a single package on the receipt date or that do not conform to the instructions contained in PHS 398 (rev. 5/95) application kit (as modified in, and superseded by, the NIAID BROCHURE ENTITLED "INSTRUCTIONS FOR ABBREVIATED APPLICATIONS FOR MULTI-PROJECT AWARDS"), will be judged non-responsive and will be returned to the applicant. The RFA label available in the application form PHS 398 must be affixed to the bottom of the face page. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. If so, a letter of agreement from either the GCRC program director or principal investigator could be included with the application. It is highly recommended that the appropriate NIAID program contact be consulted before submitting the letter of intent and during the early stages of preparation of the application. (See program contact under INQUIRIES). Submit a signed, typewritten original of the application, including the checklist, and three signed, exact, single-sided photocopies, in one package to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express mail or courier service) At the time of submission, two additional exact copies of the grant application and all five sets of any appendix material must be sent to Dr. Kevin Callahan at the address listed under INQUIRIES. Concurrent submission of an research project grant (R01) and a Component Project of a Multi-project Application: Current NIH policy permits a component research project of a multi-project grant application to be concurrently submitted as an individual research project grant (R01) application. If, following review, both the multi-project application and the R01 application are found to be in the fundable range, the investigator must relinquish the R01 and will not have the option to withdraw from the multi-project grant. This is an NIH policy intended to preserve the scientific integrity of a multi-project grant, which may be seriously compromised if a strong component project(s) is removed from the program. Investigators wishing to participate in a multi-project grant must be aware of this policy before making a commitment to the Principal Investigator and awarding institution. Special Instructions For Completion of Applications in Response to This RFA A status report on NIH reinvention activities was presented in the NIH Guide, Vol. 24, No. 40, November 24, 1995. Two of these activities are: (1) the use of "Just-in-Time" grant applications; and (2) modular budget requests and funding. "Just-in-Time" and "Modular Budgeting" along with special page limits on the research plan are used for applications in response to this RFA. JUST-IN-TIME GRANT APPLICATIONS. The basic principle of just-in-time is to simplify and reduce the administrative and paperwork burdens of preparing an NIH grant application without compromising the initial review group determination of scientific merit or reasonableness of the proposed budget. To that end, both less and less detailed information is required in just-in-time applications. Applications in response to this RFA are to use the just-in-time" format. MODULAR GRANTS. Applications are submitted and/or awards made with direct costs in modules (multiples) of a given amount ($25,000 for this RFA), with work proposed within these incremental categories. The model involves using pre-established funding levels for awards and acknowledging that grantees can and do rebudget post-award. This process eliminates the need for many budget details, thereby relieving administrative burdens on both NIH staff and grantee organizations and simplifying cost management by NIH program staff. RESEARCH PLAN PAGE LIMIT. Sections A - D of the research plan are limited to 20 pages each for: (1) the overview of the proposed program; (2) each research project; and (3) each core. The NIAID brochure, "INSTRUCTIONS FOR ABBREVIATED APPLICATIONS FOR MULTI-PROJECT AWARDS," contains specific instructions for sections of the PHS 398 (rev. 5/95) application form that must be completed differently than usual. Some sections in the application are modified and others should not be completed for submission of the application, but will be requested if the application receives a score in the fundable range. For all other items in the application, follow the usual instructions on pages 5-20 of the PHS 398 booklet. REVIEW CONSIDERATIONS Review Procedures Upon receipt, applications will be reviewed for completeness by the NIH Division of Research Grants (DRG) and for responsiveness by NIAID staff. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIAID in accordance with the review criteria stated below. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate National Advisory Allergy and Infectious Diseases Council. Review Criteria The general criteria for U19 multiproject cooperative agreement applications are presented in the NIAID BROCHURE. Additional review criteria specific to this RFA are: 1. The scientific and technical merit and significance of the application as a whole, as well as each proposed biomedical research project, in terms of enhancing fundamental knowledge on mechanisms of, intervention in, and prevention of asthma, allergic and/or immunologic diseases and contributing to the clinical application of such knowledge. 2. The cohesiveness, multi-disciplinary and multifaceted scope of the application and the coordination and interdependence of the individual projects to the common theme; the capacity of each proposed biomedical research project to contribute to the central scientific theme and to result in a greater contribution to the overall goals than if each project were pursued independently; and the capacity of each proposed project to stand on its own independent scientific merit, as well as complement the other projects. 3. The scientific and technical merit of the proposed D&E research project and its significance in terms of the potential for improving and/or preventing asthma in defined patient populations. 4. The leadership abilities, scientific expertise and experience, and administrative competence of the proposed AAIDCRC Director, including experience in directing and coordinating multi-disciplinary research programs in asthma, allergic and/or immunologic diseases and commitment to devote sufficient time and effort to the program. 5. The scientific expertise and experience of the proposed Project Leaders and key technical personnel relevant to the objectives of the RFA, including related completed and ongoing research, experience in multi-disciplinary interrelated research projects, and commitment to devote sufficient time and effort to the program. 6. The availability of adequate patient populations for the proposed D&E research project and for any proposed clinical studies, as well as the capability and experience of the key personnel and the sponsoring institution in enrollment and maintenance of study populations relevant to the application. 7. The sponsoring institution's commitment to the multiproject cooperative program, including: institutional expertise in, and collaboration/cooperation among, basic and clinical specialties required to carry out the proposed projects; support for membership of the proposed AAIDCRC Director and D&E Project Leader on the Steering Committee and willingness to abide by the scientific decisions of that Committee with respect to D&E research projects to be implemented; and willingness to accept the participation and assistance of NIAID staff. 8. Merit of the proposed plan for coordination, cooperation, and communication among AAIDCRC members within the applicant institution. 9. Adequacy of available laboratory and clinical facilities, including the institution's present patient load and access to and projections for patient involvement in clinical investigations. AWARD CRITERIA Funding decisions will be made on the basis of scientific and technical merit as determined by peer review, program balance, and the availability of funds. Schedule Letter of Intent Receipt Date: September 15, 1996 Application Receipt Date: January 15, 1997 Scientific Review Date: June 1997 Advisory Council Date: September 1997 Earliest Date of Award: September 1997 INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Requests for the NIAID brochure "INSTRUCTIONS FOR ABBREVIATED APPLICATIONS FOR MULTI-PROJECT AWARDS" as well as inquiries regarding programmatic issues, may be directed to: Daniel Rotrosen, M.D. Division of Allergy, Immunology and Transplantation National Institute of Allergy and Infectious Diseases Solar Building, Room 4A24 6003 Executive Boulevard Bethesda, MD 20892-7640 Telephone: (301) 496-8974 FAX: (301) 402-2571 Email: dr17g@nih.gov Howard B. Dickler, M.D. Division of Allergy, Immunology and Transplantation National Institute of Allergy and Infectious Diseases Solar Building, Room 4A24 6003 Executive Boulevard Bethesda, MD 20892-7640 Telephone: (301) 496-7104 FAX: (301) 402-2571 Email: hd7e@nih.gov Direct inquiries regarding preparation of the application and review issues, and address the letter of intent to, and mail two copies of the application and all five sets of appendices to: Kevin Callahan, Ph.D. Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4C20 6003 Executive Boulevard Bethesda, MD 20892-7640 Telephone: (301)496-8424 FAX: (301) 402-2638 Email: kc92t@nih.gov Direct inquiries regarding fiscal matters to: Pamela Fleming Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4B30 6003 Executive Boulevard Bethesda, MD 20892-7610 Telephone: (301) 496-7075 FAX: (301) 480-3780 Email: pf49e@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalogue of Federal Domestic Assistance Nos. 93.856 and 93.855. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This Program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. .
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