Full Text AI-95-008 COOPERATIVE CLINICAL TRIAL IN ADULT TRANSPLANTATION NIH GUIDE, Volume 24, Number 6, February 17, 1995 RFA: AI-95-008 P.T. 34 Keywords: Transplantation of Organs Clinical Trial Transplantation Immunology Immune System National Institute of Allergy and Infectious Diseases Letter of Intent Receipt Date: June 15, 1995 Application Receipt Date: October 12, 1995 PURPOSE The Division of Allergy, Immunology and Transplantation of the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), invites applications from single institutions or consortia of institutions wishing to participate in a multi-center, cooperative clinical trial to improve the outcome of kidney transplants in adult populations. The goal of this study is to evaluate new and innovative therapeutic approaches, including modifications in existing therapeutic approaches, for enhancing graft acceptance and patient/graft survival among kidney transplant recipients. Because of the importance of the immune system in graft acceptance/survival, this study also seeks to enhance basic knowledge about the immune system and foster the application of such knowledge in the clinical setting. 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 Request for Applications (RFA), Cooperative Clinical Trial in Adult Transplantation, is related to the priority area of diabetes and chronic disabling 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 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State or local government, and eligible agencies of the Federal government. Foreign organizations are not eligible to apply. Domestic applications may not include international components. Racial/ethnic minority individuals, women, and persons with disability 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 Cooperative Agreement (U01), 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. Details of the responsibilities, relationships and governance of a study funded under cooperative agreement(s) are discussed later in this document under the section "Terms and Conditions of Award." The total project period for applications submitted in response to this RFA may not exceed five years. At present, the NIAID is administratively limiting the duration of U01 cooperative agreements to four years; this administrative limitation may change in the future. At this time, the NIAID has not determined whether and how this solicitation will be continued beyond the present RFA. FUNDS AVAILABLE The estimated total funds (direct and indirect costs) available for the first year of support for awards under this RFA will be $1,800,000. In Fiscal Year 1996, the NIAID plans to fund at least 4 new and/or recompeting Adult Transplantation Units (ATUs) either as individual projects or as a consortium. It is anticipated that the size of awards will vary depending on the number of participating institutions and the number of potential study participants. The NIH is currently limiting annual inflationary increases to no more than four percent for future years of awards. The usual PHS policies governing grants administration and management will apply. This level of support is dependent on the receipt of a sufficient number of applications of high scientific merit. 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. RESEARCH OBJECTIVES Background Although kidney transplantation is the most effective therapeutic regimen for the treatment of end-stage renal disease, several factors continue to limit the success of this preferred therapy. The major remaining obstacles, other than the shortage of donor organs, relate to rejection of the transplanted organ and to limitations of the immunosuppressive therapies currently employed to prevent or control rejection. Although currently employed immunosuppressive therapies have greatly improved the success rate of kidney transplants, their side effects and the relatively poor long-term survival rate indicate the need for new and more efficacious treatment approaches and regimens. In September 1991, the NIAID established the Cooperative Clinical Trial in Transplantation (CCTT) to expedite the evaluation of new treatment modalities to prevent kidney graft rejection. The eight centers participating in this cooperative research program have explored multiple protocols focused on inducing tolerance in kidney graft recipients and on new agents to reverse kidney graft rejection. The CCTT has completed an evaluation of murine OKT4A induction, the results of which have been presented and will be published shortly. In addition, the following three protocols are currently open to enrollment: (1) a living, donor specific blood transfusion protocol; (2) a protocol using bone marrow infusion just after kidney transplantation as a means of inducing donor specific unresponsiveness; and (3) an evaluation of Rapamycin for acute rejection. Copies of all completed and ongoing protocols used by the CCTT will be made available to applicants upon request to the program contact listed under INQUIRES. Research Objectives and Scope The purpose of this RFA is to continue NIAID support for prospective, multi- center, cooperative clinical trials in adult kidney transplant recipients to evaluate many additional agents and therapeutic modalities as they become available. These include new drugs and unique combinations of different drugs or antibodies, as well as approaches for pretreating both the transplant recipient and the donor organ. In addition, efficacy and safety data being generated from the current cooperative research program will be instrumental in designing new protocols. The primary objectives of this RFA include, but are not limited to, the following: o design and implement common protocols, in a controlled setting, evaluate therapeutic approaches for enhancing kidney graft survival in adult transplant recipients; o evaluate new and innovative therapeutic approaches, including modifications in existing therapeutic approaches, as a means of improving outcome. Specifically, approaches should be aimed at inducing transplant tolerance; and o conduct appropriate laboratory studies in support of the common protocols to elucidate the basic mechanisms involved. Although it is recognized that many factors may play a role in enhancing outcome, such as compliance, socioeconomic factors, and other systems (e.g., the endocrine system), the limited funds available for this RFA may preclude study of each and every such factor. Emphasis will be focused on the immune system. Study Design In order to accumulate sufficient sample size for the study, a collaborative effort will be required by at least four ATUs, funded as either individual projects or as a consortium. In this collaborative effort, the ATUs will follow uniform study protocols with standardized data collection procedures. The protocol will focus on adult kidney transplant recipients and will involve a controlled design to evaluate new and innovative therapeutic approaches, including modifications in existing therapeutic approaches, to enhance graft survival. A key feature of the strategy will be inducing tolerance to the donor kidney. NOTE: Although the actual protocols to be conducted will be designed by the Steering Committee, applications must include a proposed protocol that meets the objectives and scope of this RFA. SPECIAL REQUIREMENTS A. Study Organization 1. Steering Committee A Steering Committee will be established to serve as the main governing body of the study. At a minimum, the Steering Committee will be composed of the NIAID Adult Transplantation Research Coordinator (ATRC) and one representative from each participating institution as follows: the Principal Investigator of each ATU whether a single institution or a consortium of institutions, and a Senior Investigator from each additional institution participating in a consortium arrangement. The Senior Investigator is the person responsible for on-site scientific direction and implementation of the consensus protocol at institutions participating in a consortium arrangement. Senior Investigators must be physicians with substantial experience in (1) kidney transplantation; (2) immunosuppression; and (3) the design, implementation and evaluation of clinical trials. All major scientific decisions will be determined by the Steering Committee, with each Principal Investigator, Senior Investigator, and the NIAID ATRC having one vote. 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 ATRC. The Committee will meet at least three times during the first 12 months of the study and at least semi-annually thereafter. This Committee will have primary responsibility for developing the common protocols, facilitating the conduct and monitoring of the study, analyzing and interpreting study data, and reporting study results. The study will proceed into the implementation stage only with the concurrence of both the awardees and the NIAID ATRC. Topics for the protocols will be proposed and prioritized by the Steering Committee. Each Principal Investigator and Senior Investigator (or his/her designee) will be expected to participate in all other Steering Committee activities, e.g., conference calls, special subcommittees as may be necessary, etc. Subcommittees of the Steering Committee may be established as necessary. At a minimum, the Steering Committee will establish an Immunology Research Advisory Subcommittee to provide advice to the Steering Committee with respect to research on the immune system. The Immunology Research Advisory Subcommittee will be composed of one representative selected by each member of the Steering Committee, as well as the NIAID ATRC. This Subcommittee will meet annually in conjunction with one of the Steering Committee meetings. 2. Data and Safety Monitoring Board An independent Data and Safety Monitoring Board, to be appointed by the NIAID, will review progress at least annually and report to the NIAID ATRC. Protocols will be subject to review by the Data and Safety Monitoring Board in an advisory capacity. 3. Data Coordination and Management The NIAID will be responsible for ensuring the provision of centralized data management and coordination assistance through the establishment of a Clinical Coordinating Center, to be funded separately from this Cooperative Agreement. The Clinical Coordinating Center will have primary responsibility for quality control and uniformity of data collection, as well as for managing the collective data base. Under the direction of the Steering Committee, ATUs will submit data to the Clinical Coordinating Center; specific data analyses to be carried out will be determined by the Steering Committee and the results of those analyses will be delivered to the Steering Committee as the group responsible for determining which further analyses should be done, how the results are interpreted, whether the results should influence ongoing data collection, and how the findings should be disseminated. Although the ATUs will be closely involved with these centralized data collection and management services, applicants should not include in their budget requests support for any of these functions. However, the budget should include appropriate support for personnel required for data acquisition and entry (commonly referred to as a Data Coordinator). This function may be performed by the Study Coordinator at the discretion of the applicant. B. 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 HHS, PHS, and NIH Grants Administration policy statements. The administrative and funding instrument used for this program is the cooperative agreement (U01), 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 study will be shared among the awardees and the NIAID PTRC. 1. Awardee Rights and Responsibilities Awardees will have primary responsibility for defining the details for the project within the guidelines of the RFA and for performing the scientific activity, and agree to accept close coordination, cooperation, and participation of NIAID staff in those aspects of scientific/programmatic management of the projectas stated below under "NIAID staff responsibilities." Steering Committee Membership and Meeting Attendance Each Principal Investigator and Senior Investigator will serve as a voting member of the Steering Committee and will participate in all scientific decisions. Each Principal Investigator and Senior Investigator (or his/her designee) will be responsible for attending all Steering Committee meetings, including not less than three meetings during the first twelve months of the study and two per year thereafter. The Steering Committee shall be responsible for determining the frequency of meetings and scheduling the time and location. Each Principal Investigator and Senior Investigator (or his/her designee) will be expected to participate in all other Steering Committee activities, e.g., conference calls, special subcommittees as may be necessary, etc. Subcommittees of the Steering Committee may be established as necessary. At a minimum, the Steering Committee will establish an Immunology Research Advisory Subcommittee to provide advice to the Steering Committee with respect to research on the immune system. The Immunology Research Advisory Subcommittee will be composed of one representative selected by each member of the Steering Committee, as well as the NIAID Adult Transplantation Research Coordinator (ATRC). This Subcommittee will meet annually in conjunction with one of the Steering Committee meetings. Protocol Development and Conduct The Steering Committee will define protocol objectives and approaches and design the consensus protocols. Each awardee will follow the procedures required by the consensus protocols generated by the Steering Committee regarding study conduct and monitoring, patient management, data collection and quality control. Data Coordination and Management Each awardee will be responsible for providing to the Clinical Coordinating Center all primary study data for management, quality control and analysis, using procedures and standards determined by the Steering Committee. All data will be available to all awardees. Specific analyses to be performed by the Clinical Coordinating Center will be directed 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. Publication and Presentation of Study Findings Early publication of major findings is encouraged. Publications and oral presentations of work performed under this agreement will require appropriate acknowledgement of both the ATUs and NIAID support. Analyses to be performed using the collective data from all ATUs will be determined and directed by the Steering Committee. ATUs wishing to perform analyses of local data 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 prior to publication or presentation according to criteria that will be developed by the Committee. Monitoring Study Progress The Steering Committee will establish mechanisms for assessing performance of the ATUs, including institutions participating in consortia arrangements, with particular attention to accrual of adequate numbers of eligible patients, timely submission and quality of required data and conscientious observance of protocol requirements. Federally Mandated Regulatory Requirements Each ATU, and each institution participating in a consortium arrangement, is required to meet the DHHS/PHS regulations for the protection of human subjects and FDA requirements for the conduct of research using investigational agents. At a minimum, these include: o methods for assuring that each institution at which ATU investigators are conducting clinical studies has a current, approved assurance on file with the Office of Protection from Research Risks (OPRR); that study protocols are reviewed and approved by the responsible Institutional Review Board (IRB) prior to patient entry; that active protocols are reviewed at least annually by the IRB; and that amendments are approved by the IRB. o methods for assuring or documenting that each patient, or patient's parent/legal guardian, gives fully informed consent to participation in a research protocol prior to the initiation of the experimental intervention. 2. NIAID Staff Responsibilities The NIAID ATRC 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 ATRC will serve as a voting member of the Steering Committee, will attend all Steering Committee meetings, and will participate in other Committee activities, e.g., conference calls, special subcommittees. The NIAID ATRC will also serve on the Immunology Research Advisory Subcommittee. Protocol Development As a member of the Steering Committee, the NIAID ATRC will serve as a resource with respect to the design of the protocol and will assist the Steering Committee in protocol development. Study Materials The NIAID will be responsible for the acquisition and distribution of those study materials involved in the protocol developed by the consensus of the Steering Committee. The NIAID will also arrange for the appropriate approvals (when necessary) from the Food and Drug Administration (FDA) and the Bureau of Biologics (BOB) with respect to the use investigational drugs. Monitoring Study Performance The NIAID ATRC will provide assistance to the Steering Committee in the development of mechanisms and procedures for monitoring study performance. This includes participation in periodic on-site monitoring with respect to compliance with protocol specifications, quality control and accuracy of data recording, and accrual. Data Coordination and Management The NIAID will establish a Clinical Coordinating Center, independent of and supported separately from the ATUs, to provide technical assistance and data management services to the ATUs with respect to quality control, uniformity of data collection, management of the collective data base, and data analysis. The Government, via the NIAID ATRC, will have access to data generated under this 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 internal 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 ATRC may contribute, through review, comment, analysis, and/or co-authorship, to reporting results of the study to the investigator community and other interested scientific and lay organizations. Co-authorship by the NIAID ATRC 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 ATRC. These changes include the addition/deletion of a physician, scientific investigator, affiliate, component, or research base that is associated with this study. A change in the Principal Investigator, or 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 ATRC. Program Review The NIAID ATRC will review the progress of each ATU through consideration of the annual reports, site visits, patient logs, etc. This review may include, but is not limited to, compliance with the study protocol, meeting patient enrollment targets, adherence to uniform data collection procedures, and the timeliness and quality of data reporting. The NIAID reserves the right to terminate or curtail the study (or any individual award) in the event of (a) substantial shortfall in participant recruitment, follow-up, data reporting, quality control, or other major breech of the protocol, (b) substantive changes in the agreed-upon protocol to which the NIAID does not agree, (c) reaching a major study endpoint substantially before schedule with persuasive statistical significance, or (d) human subject ethical issues that may dictate a premature termination. 3. Collaborative Responsibilities A Steering Committee, composed of the Principal Investigators, Senior Investigators of institutions participating in a consortium, and the NIAID ATRC, will be the main governing body of the study and will have primary responsibility for all scientific decisions, including: defining protocol objectives and approaches; designing and implementing protocols; developing procedures for data collection, management and quality control; establishing procedures for assessing performance with respect to accrual, timely submission and quality of data, and conscientious observance of protocol requirements; analyzing and interpreting study data; and publishing/presenting study findings. Each member of the Steering Committee will have one vote. The chairperson will be selected by the Steering Committee from among the non-Federal members. Subcommittees will be established by the Steering Committee, as it deems appropriate. At a minimum, the Steering Committee will establish an Immunology Research Advisory Subcommittee to provide advice with respect to research on the immune system. The Immunology Research Advisory Subcommittee will be composed of one representative selected by each member of the Steering Committee, as well as the NIAID ATRC. This Subcommittee will meet annually in conjunction with one of the Steering Committee meetings. An independent Data and Safety Monitoring Board, to be appointed by the NIAID, will review progress at least annually and report to the NIAID ATRC. The protocol will be subject to review by this Board in an advisory capacity. Awardees will be required to accept and implement the common protocols and procedures approved by the Steering Committee. The study will proceed into the implementation stage only with the concurrence of the awardees and the NIAID ATRC. 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 -- one 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 selected by the NIAID, and the third member selected by the two prior members. This special arbitration procedure in no way affects the awardee's rights to appeal an adverse action that is otherwise appealable in accordance with the PHS regulations at 42 CFR part 50, subpart D and HHS regulation at 45 CFR part 16. 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 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 has 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 the program staff or contact person listed below. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by June 15, 1995, a letter of intent that includes a descriptive title of the overall proposed research, the name, address, and telephone number of the Principal Investigator, the number and title of this RFA, and a list of the key investigators and their institution(s). 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. Strickland at the address listed under INQUIRIES. APPLICATION PROCEDURES Applications are to be submitted on the standard research grant application form PHS 398 (rev. 09/91). These application forms may be obtained from the institution's office of sponsored research or its equivalent, and from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone (301) 710-0267. For purposes of identification and processing, item 2a on the face page of the application must be marked "YES" and the RFA number and the words "COOPERATIVE CLINICAL TRIAL IN ADULT TRANSPLANTATION" must be typed in. The RFA label in the PHS 398 application form 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. Applications from multi-component consortia must contain a single face page, an overall budget page, and separate budget pages for each institution involved. Each consortium institution is allowed 25 pages for the research plan if different plans are proposed by the different member institutions. Applications must address the requirements below: 1. Applications should include a proposed protocol that meets the objectives and scope of this RFA, as well as a discussion of the rationale for the patient population, the study design and the therapeutic approach selected for study, and an assessment of how anticipated study results can be expected to contribute to improvements in graft survival. 2. The applicant institution and each participating institution associated with an applicant consortium must document their experience and capacity to recruit and retain study participants, provide a description of the population currently available for the proposed protocol, and describe proposed mechanisms for monitoring accrual performance and criteria for continued participation. 3. Applications must name a single Principal Investigator (PI) who will have scientific responsibility for the application as a whole including all ATU-related research activities included under it. The PI must be a physician with substantial experience in (1) kidney transplantation; (2) immunosuppression; and (3) the design, implementation and evaluation of clinical trials. In addition, applications from consortia of institutions must name a single Senior Investigator for each participating institution (other than the applicant institution) who will be responsible for on-site scientific direction and implementation of the consensus protocol. Senior Investigators must also be physicians with substantial experience in (1) kidney transplantation; (2) immunosuppression; and (3) the design, implementation and evaluation of clinical trials. 4. The application must name a Project Coordinator who is an individual with substantial technical/administrative experience in managing patient enrollment, patient follow-up, and multi-source data collection for clinical studies. Each participating institution associated with an applicant consortium much also name such a Project Coordinator. 5. The application must provide: a clear, concise plan in narrative and diagrammatic form that depicts the interrelationships among the members of the ATU, their relevant experience/expertise, and the contribution of each to fulfillment of the objectives of this RFA; an organizational chart of the ATU showing the name, organization, and scientific discipline of the PI and of all key scientific, technical and administrative personnel; and a mechanism for selecting and replacing key professional or technical personnel. 6. The application must provide a plan to ensure the maintenance of close cooperation and effective communication among members of the ATU, whether a single institution or a consortium of institutions, including letters of commitment to this plan from all participating institutions. 7. The application should discuss the capability of the applicant organization and each institution in an applicant consortium to participate and interact effectively in cooperative, multi-center clinical trials. 8. The application 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." The application must also include a written commitment to the cooperative organization and willingness to serve on the Steering Committee and adhere to the decisions reached by that Committee, including following the consensus protocol. 9. All costs required for the proposed protocol must be included in the application and must be fully justified. These include the additional costs of clinical research associated with the proposed protocol, costs for patient recruitment and follow-up, laboratory studies, data collection, and participation in on-site quality assurance audits. Requested budgets should also include: (1) travel to the Washington, DC area for three two-day Steering Committee meetings during the first 12 months of the study and semi-annual Steering Committee meetings thereafter for the Principal Investigator and Senior Investigator(s) of each institution participating in an applicant consortium, and (2) travel to the Washington, DC area for annual one-day meetings of the Immunology Research Advisory Subcommittee for one representative from each ATU and each institution participating in a consortium arrangement. It is highly recommended that the Chief of the Genetics and Transplantation Branch, NIAID Division of Allergy, Immunology and Transplantation, be contacted in the early stages of preparation of the application. (See program contact in INQUIRIES below.) Applications must be received by October 12, 1995. Applications received after the receipt date will be returned without review. Applications that do not conform to the instructions contained in PHS 398 (rev. 9/91) application kit, will be judged non-responsive and will be returned to the applicant. The Division of Research Grants (DRG) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. This does not exclude the submission of substantial revisions of an application already reviewed. These applications must, however, include an introduction addressing the previous critique. Submit a signed, typewritten original of the application, including the checklist, and three signed, exact, single-spaced photocopies, in one package to; Division of Research Grants National Institutes of Health 6701 Rockledge Drive, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (express mail) At the time of submission, two additional exact copies of the grant application and all five sets of appendix material must also be sent to Dr. Strickland at the address listed under inquiries. 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. 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 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 promptly notified. The second level of review will be provided by the NIAID Advisory Councils. Review, Council and award dates are listed under Schedule. Review Criteria Applicants are expected to address the requirements identified under APPLICATION PROCEDURES. The review criteria for applications in response to this RFA are: o scientific, technical, or medical significance and originality of proposed research; o appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research; o qualifications and research experience of the Principal Investigator and staff, particularly, but not exclusively, in the area of the proposed research; o availability of the resources necessary to perform the research; o appropriateness of the proposed budget and duration in relation to the proposed research; o adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. The initial review group will also examine 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 needs and 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. Direct inquiries regarding programmatic issues to: Stephen M. Rose, Ph.D. Division of Allergy, Immunology and Transplantation National Institute of Allergy and Infectious Diseases Solar Building, Room 4A14 6003 Executive Boulevard Bethesda, MD 20892-7640 Telephone: (301) 496-5598 FAX: (301) 402-2571 Email: sr8j@nih.gov Direct inquiries regarding review issues, address the letter of intent to, and mail two copies of the application and all five sets of appendices to: Paula S. Strickland, Ph.D. Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4C02 6003 Executive Boulevard Bethesda, MD 20892-7610 Telephone: (301) 402-0643 FAX: (301) 402-2638 Email: ps30f@nih.gov Direct inquiries regarding fiscal matters to: Ms. Carol Alderson Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4C26 6003 Executive Boulevard Bethesda, MD 20892-7610 Telephone: (301) 496-7075 FAX: (301) 480-3780 Email: ca10h@nih.gov Schedule Letter of Intent Receipt Date: June 15, 1995 Application Receipt Date: October 12, 1995 Scientific Review Date: March 1996 Advisory Council Date: May 1996 Earliest Award Date: July 1996 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, No. 93.855 - Immunology, Allergy and Transplantation Research. Awards will be made under the authority of the Public Health Service Act, Title III, Section 301 (Public Law 78-410, as amended; 42 USC 241) and administered under PHS grants policies and Federal Regulations 42 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 recipients to provide a smoke- free work place and promote the nonuse 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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