HUMAN PANCREATIC ISLET CELL RESOURCES ADMINISTRATIVE AND BIOINFORMATICS COORDINATING CENTER Release Date: November 8, 2001 RFA: RFA-RR-02-002 National Center for Research Resources (http://www.ncrr.nih.gov) Letter of Intent Receipt Date: January 7, 2002 Application Receipt Date: February 22, 2002 PURPOSE The National Center for Research Resources (NCRR) invites applications to establish the Administrative and Bioinformatics Coordinating Center (ABCC) to coordinate the activities of the consortium of Islet Cell Resource centers (ICRs). Ten ICRs have recently been established to isolate, purify and characterize human pancreatic islet cells for transplantation into diabetic patients. Applicants will compete under this RFA to coordinate ICRs' activities, organize their meetings, and correlate data that reflect the efficacy of both the methods used to prepare islets and the assays to predict functionality and clinical outcome. The ABCC will also manage the relevant laboratory and clinical data generated through the activities of the ICRs. While the ABCC may be located within the same institution as one of the selected ICRs, the director of the ABCC must remain independent of that ICR and any other ICR to both preserve the integrity of the studies and avoid any perceived or real conflict of interest. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and not-for-profit organizations, public and private organizations, such as universities, colleges, hospitals, laboratories, units of state and local governments, and eligible agencies of the Federal government. Foreign institutions are not eligible to receive awards under this solicitation. Individual members of racial and/or ethnic minority groups, women, and persons with disabilities are encouraged to apply as principal investigators. All current policies and requirements that govern the research grant programs of the National Institutes of Health (NIH) will apply to the grant awarded under this RFA. MECHANISM OF SUPPORT The administrative and funding instrument to be used for this program will be the cooperative agreement (U42), an assistance mechanism rather than an acquisition mechanism, in which substantial NIH scientific and/or programmatic involvement with the awardees is anticipated during performance of the activity. Under a cooperative agreement, the NIH supports and/or stimulates the recipients' activities by working in partnership with the awardee, without assuming the direction of, prime responsibility for, or dominance in the activities. Responsibilities for the project as a whole reside with the awardees, although specific tasks and activities are shared among the awardees and the NIH Institutes and Centers (ICs). Details of the responsibilities, relationships, and governance of studies funded under a cooperative agreement are discussed later in this document under the section entitled "Terms and Conditions of the Award." The anticipated award date is July 2002. The total project period for an application submitted in response to this RFA may not exceed five years. Although this RFA is currently anticipated to be a one-time solicitation, if it is determined that there is a sufficient, continuing need, NCRR will invite competitive new and/or competitive continuation cooperative agreement applications for review in accord with the procedures described in REVIEW CONSIDERATIONS. FUNDS AVAILABLE One award for an ABCC will be made under this RFA. Over its five-year duration, the award would be up to $3.5 million (total direct costs) to support its infrastructure. Although the financial plans of the NCRR provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of applications of appropriate scientific and technical merit. Designated funding levels are subject to change at any time prior to final award, due to unforeseen budgetary, administrative, or scientific developments. It is not known if new or competing renewal applications will be accepted or if this RFA will be reissued. RESEARCH OBJECTIVES Background Diabetes mellitus affects approximately 16 million people in the United States. Individuals with Type I diabetes have lost their ability to manufacture sufficient amounts of insulin due to autoimmune destruction of the insulin-producing beta cells that are grouped with other types of secretory cells within the "islets of Langerhans" of the pancreas. While injection of exogenous insulin has long been the standard treatment for patients with Type I diabetes, transplantation of human islet cells may be an alternative. However, the recovery of functional pancreatic islets is a complex procedure and needs to be optimized. Several aspects of the process may be critical: the clinical status of the donor before removal of the pancreas, surgical procedures involved in its excision, the enzymatic dispersal of the pancreatic components, the transplantation procedure and the recipient's immunosuppression remain to be optimized. Selection of appropriate recipients for islet transplantation requires characterization of the target population with particular attention to their response to insulin therapy. Reports from the Diabetes Control and Complications Trial (DCCT) suggest that intensive treatment regimens that achieve tight control of blood glucose can significantly reduce the onset and progression of resultant complications in individuals with Type I diabetes. However, some diabetic patients practicing tight control experience lability of blood glucose levels in response to changes in health status, diet, exercise, or insulin dose. Because even small changes in their daily regimen may interfere with glucose control, these diabetic patients are said to be "brittle". For this subpopulation, insulin therapy is life saving, but may lead to frequent adverse events such as severe hypoglycemia. Islet cell transplantation could provide significant benefits to brittle diabetics for whom effective regulation by insulin therapy is difficult. Objectives and Scope The objectives of this RFA are to establish a coordinating center that will facilitate the ICR efforts to optimize 1) isolation procedures to obtain high yields of functional islet cells and providing well- characterized islet cells for transplantation into Type I diabetes patients, 2) the distribution of islet cells to investigators for clinical or basic research, and 3) the development of isolation procedures that result in maximal islet cell function upon transplantation. The ABCC will 1) be responsible for the organization and conduct of Steering Committee meetings whose agendas would include review of requests for islets and evaluation of ICR progress; 2) develop databases, collect data, organize and analyze the methods and assays used to produce islet cells and correlate these data with post- transplant islet cell function; 3) correlate clinical trial data such as patient and donor demographics and baseline assessments, and relevant laboratory and clinical data that result from the use of the islets generated. The ABCC will maintain the database into which all ICRs and collaborating institutions will deposit their data for subsequent analysis. Respondents to this RFA should also address issues such as data storage, archiving, retrieval, analysis and data mining, quality control issues, security, and information transfer in the application. Applicants should also include proposals to assist the network of ICRs in: 1) recruiting and evaluating pancreas donors, 2) obtaining human pancreata; 3) distributing islets to both clinical and basic science researchers; 4) ensuring quality control of islet cell isolation and provide a scientific basis for their use in transplantation or basic research; 5) determining the physiologic and genomic components that are correlated with longevity, function and portability of pancreatic islets; 6) facilitating approved transplantation protocols and correlate consequent clinical responses with characteristics of the islets provided. The research plan should follow the instructions in the PHS 398 application form (rev. 5/01, https://grants.nih.gov/grants/forms.htm). Program Structure Applicants should possess expertise and technologies relevant to this RFA, providing a structure that can coordinate activities between basic science investigators and clinicians to translate basic research discoveries into clinical applications. This includes a thorough understanding of current Good Manufacturing Practice (cGMP), Good Laboratory Practice (GLP), clinical trial and cell therapy procedures, and expertise in biostatistics and bioinformatics. The ABCC will serve the administrative functions common to the ICRs, house the bioinformatics core, maintain the consolidated database, provide administrative oversight of the Steering Committee and coordinate ICR activities such as complex assays and unique technologies that would best be housed in a generally accessible, single core. Independence of the ABCC applicant from any ICR must be clearly described in a manner that documents the absence of a conflict of interest. The application for this award should include a plan that describes its proposed function, its resources and how it would facilitate ICR interactions. The Steering Committee will be responsible for scientific oversight and development of collaborative interactions among the ICRs. An ABCC representative will assist the Steering Committee Chairman and participate in Steering Committee meetings as a voting member. NIH-supported investigators from both within and outside of the ICRs must submit requests to the Steering Committee through the ABCC for islets or for any ICR core service. The Steering Committee would then evaluate these requests based on scientific merit. If required, the NCRR may provide a core with additional support for such requests by considering the scientific review, program relevance and availability of funds. Specialized Resource Facilities and Services Applicants should document the availability of unique expertise and equipment that would assist the awardee in achieving the goals outlined within this RFA. The application should, at minimum, address: Experience of key personnel Experience in coordinating multi-center research programs Biostatistical and bioinformatics experience and plans Existing computer facilities Coordination of core resources among ICRs Human Subjects issues Data Safety Monitoring Plan Proposed Steering Committee function Interaction with the ICRs SPECIAL REQUIREMENTS The cooperative agreement (U42) will require collaboration among the NCRR Program Coordinator, the ICR Steering Committee and its Chairman and the ABCC in order to assure efficiency and progress toward the stated goals of this RFA. Plans to develop these synergistic relationships should be addressed in each application. The following terms and conditions will be incorporated into the award statement and provided to both the Principal Investigator and institutional official at the time of award. Terms and Conditions of Award These special Terms and Conditions of Award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS Grant Administration Regulations at 45 CFR Parts 74 and 92, and other HHS, PHS, and NIH Grant Administration policy statements. 1. Awardee Rights and Responsibilities The ABCC Director must agree to participate as a voting member of the ICR Steering Committee. The ABCC Director, in cooperation with the Steering Committee Chairman, ICR Directors, and the other Steering Committee members, will be responsible for developing the details of the ICR operating policies and documents, including the definition of objectives, protocols, implementation, and interaction between the ICRs to establish a clinical islet cell resource program that is responsive, efficient, and ethical. The ABCC Director will have primary responsibility, with concurrence from the Chairman of the ICR Steering Committee and the NCRR Program Coordinator, in organizing Steering Committee meetings. The ABCC will be responsible for administrative matters related to Steering Committee meetings, including preparing agendas, writing and distributing minutes, communicating with outside investigators and the lay public and receiving investigators' applications that request ICR services. In addition, the ABCC will maintain close contact with the ICRs, the NCRR Program Coordinator, and the ICR Steering Committee. It will assist in coordinating the research programs and core resources among the ICRs, provide biostatistical and bioinformatics support to the ICRs, maintain current and relevant databases, arrange appropriate advertising and publicity for the ICRs upon approval by the Steering Committee and prepare a comprehensive annual report for the program in a timely fashion. The ABCC Director must present an update of his/her relevant activities at each meeting that will be held either by telephone conference call or in the metropolitan Washington D.C. area. The ABCC will be responsible for all administrative aspects of the Steering Committee meetings. The ABCC Director will be responsible for submission of the ABCC Annual Progress Report and other reports to NCRR in compliance with NIH and other Federal Guidelines. 2. I/C Staff Responsibilities One Health Scientist Administrator from the NCRR will be designated to serve as the NCRR Program Coordinator of this cooperative agreement. This individual will assist in coordinating the activities of the ICRs and ABCC and in facilitating exchange of information between them and NCRR. NCRR reserves the right to terminate or modify this award in the event of (a) failure to develop, implement or maintain mutually acceptable procedures, (b) substantial shortfall in efficiency, data reporting, quality control, or other such major breach, (c) substantive changes in agreed-upon policies or procedures with which the Funding Entities cannot concur, (d) ethical issues, (e) significant non-compliance with relevant Federal guidelines. 3. Collaborative Responsibilities The ICR Steering Committee membership will include the ICR Directors, the ABCC Director, the NCRR Program Coordinator, one NIDDK Program Officer, one JDRFI Representative, and outside experts recommended by the ICR Directors to balance the composition and size of the Steering Committee to both provide requisite expertise and guarantee that the entire number of NIH representatives does not exceed 40 percent of the total membership. Each member, including the outside experts, will have one vote on matters discussed at the Steering Committee meeting. The ICR Steering Committee Chairperson is appointed by the Director of the Division of Clinical Research, NCRR. The Steering Committee coordinates and facilitates the activities supported by this cooperative agreement. As a member of the Steering Committee, the Director of the ABCC will participate in the establishment of the policies and operating procedures of both itself and the ICRs. The ABCC will assist in the generation of the Policy and Procedure Document. The Document will include descriptions of the requirements for basic and clinical research protocols to use ICR- generated islets including quality control, quality assurance, testing procedures, human subjects protection, conflict of interest, and intellectual property and regulatory issues as they evolve throughout the duration of the studies. The Steering Committee will also make provisions for an arbitration panel as described below. Criteria for accession and discontinuance of use of the ICR facility will also be delineated. The Director of NCRR will review and must approve these ICR guidelines prior to their implementation. The Steering Committee will meet three times during the first year of ICR awards and semi-annually, thereafter. The ABCC will work with the ICR Directors to formulate consistent policies for dealing with recurring situations that require coordinated action at Steering Committee meetings. Data and Safety Monitoring Board All clinical protocols supported by ICR resources must engage a Data and Safety Monitoring Board (DSMB), which will provide overall monitoring of interim data and safety issues. The DSMBs should be assembled by the institutions or funding organizations that sponsor those clinical protocols. Intellectual Property The Bayh-Dole Act is implemented through Department of Commerce regulations 37 CFR 401. These regulations define terms, parties, responsibilities, prescribe the order of disposition of rights, prescribe a chronology of reporting requirements, and delineate the basis for and extent of government actions to retain rights. The patent rights clauses are found at 37 CFR Part 401.14 and are accessible from the Interagency Edison web page, www.iedison.gov . ICR awardees will have primary rights to their data developed under these awards, subject to Government rights of access consistent with current Federal policies. Database Information developed as a result of ICR activities will be held in a central database by the ABCC. Such data will include, for example, laboratory procedures, methods of data analysis and reports. The database will not be distributed to the public until the relevant studies have been completed and only with the concurrence of the Steering Committee. The database must be designed to protect patient identity and ensure the privacy of their medical and genetic data. Publication After approval by the Steering Committee, the awardee will facilitate the publication and public dissemination of results, data and other information developed by this cooperative agreement. Such documents, written by an individual ICR or by a consortium of ICRs, may be published only after approval by the Steering Committee. However, during or within three years beyond the end date of the project support period, unpublished data, unpublished results, data sets not previously released, or other study materials or products are to be made available to any third party only with the approval of the Funding Entities and in accordance with the stipulations within this document. Arbitration Any disagreement that may arise between the award recipient and NCRR on scientific or programmatic matters may be brought to arbitration. A panel of external consultants will be created, and convened as needed, to resolve any irreconcilable differences of opinion related to such matters. The panel will include one member selected by the awardee, one member selected by NCRR, and a third member chosen by the other two members of the arbitration panel. These special arbitration procedures in no way affect an awardee's right to appeal an adverse determination in accordance with PHS regulations at 42 CFR part 50, subpart D and HHS regulations at 45 CFR part 16. Applicants should anticipate probable areas of conflict and put forward an arbitration plan in their applications. LETTERS OF INTENT Prospective applicants are asked to submit a letter of intent that includes a descriptive title of the proposed application, the name, address, and telephone number of the Principal Investigator and his/her institution, the identities of other key personnel, and the number and title of this RFA. Although a letter of intent is neither required nor binding, and does not enter into the review of a subsequent application, its contents allow NCRR staff to estimate the potential review workload and plan the review. The letter of intent is to be faxed, e-mailed, or mailed to Charles H. Hollingsworth, Dr.P.H., at the address listed under INQUIRIES by January 7, 2002. APPLICATION PROCEDURES The PHS 398 research grant application instructions and forms (rev. 5/2001) available at https://grants.nih.gov/grants/funding/phs398/phs398.html must be used in applying for these grants. This version of the PHS 398 is available in an interactive, searchable format. For further assistance contact GrantsInfo, Telephone 301/710-0267, Email: GrantsInfo@nih.gov. Material to Include in the Application An application to establish the ABCC should be submitted by the proposed Director who will be responsible for organizing and maintaining the ABCC program. A clear description of the plans for communication, interaction, collaboration and sharing between ICRs should be included. The proposed Director should also articulate procedures for handling day-to-day issues, both administrative and scientific. The Director should have the responsibility for oversight and coordination of all projects or components involving the ABCC. Support for at least 0.25 FTE will be provided for the position of ABCC Director. Provision will be made for partial support for qualified support staff to assist in the direction of the ABCC and additional support for individuals to perform technical procedures. The application should detail how this would be accomplished In addition, the applicant must describe any collaborating institution that would participate with the ABCC in achieving the goals described in this RFA. Each application must also describe any institutional oversight procedures to be employed and must clearly outline the proposed administrative and organizational structure of their proposed ABCC, including integration, collaborative arrangements, and roles for key participants from all institutions engaged in ABCC activities. The applicant must also state willingness to participate in the Steering Committee and agree to abide by its governance. Description of Proposed Resources Applicants to this RFA should consider the points below as examples of relevant information to include in the application. These are examples only and should not be construed as being required or limiting. Applicants are encouraged to address these and/or other points pertinent to the objectives of the RFA. Each application for the ABCC award must propose the procedures to administer the ICR Program, identify functions common to all ICRs that will be facilitated, describe the procedures that will maintain a current database and manage an intranet web site. Only one ABCC will be selected based upon peer-review of these proposals. Convey an understanding of the scientific, statistical, logistical, and technical issues underlying multi-center studies, including those relating to islet cell isolation and islet cell transplantation. Describe the qualifications of the applicant to take a leadership role in the area of study design, statistics, logistics, data acquisition and management, patient confidentiality, handling of laboratory specimens, quality control, data analysis, cGMP and GLP compliance and network coordination. Describe plans for interaction with the NIDDK-supported Islet Cell Transplant Registry. Since the ICRs must comply with the intent of cGMP for Phase I and II clinical trials, isolation of islet cells must follow a set of current, scientifically sound methods, practices or principles that are implemented and documented during product development and production to ensure the consistent production of islet cells that can be administered safely and with consistent purity and functional capacity. Describe the applicant's experience in and knowledge of elements of cGMP that would be used in the isolation of islet cells, such as: a)adequate documentation/records; b) production and process controls; c) quality control/assurance; and d) submission of relevant information to the FDA in support of an IND application. Address the expertise, training and experience of the proposed ABCC staff, including the administrative abilities, in operating a "coordinating center" of the kind described in this RFA. Provide a plan to acquire, transfer, manage, analyze and monitor basic laboratory information and clinical data generated through the use of ICR resources. Propose a process to coordinate the activities of all of the ICRs and those of the Steering Committee. Include the administrative, supervisory, and collaborative arrangements for achieving the goals of the program, and a willingness to cooperate with the ICRs, the Steering Committee and NCRR Program Coordinator. Describe the facilities, equipment, and organizational structure available to coordinate ICR basic and clinical research activities. Describe how assay and disbursement data will be tracked for each lot of islet cells. Outline the procedure to collate and analyze data from ongoing clinical and basic research studies that use ICR resources. Describe any data management services will be provided to the ICRs. Provide a description of the statistical support for protocol design and analyses of completed protocols. Describe the plan to interact with the DSMBs that are responsible for oversight of the clinical protocols that utilize ICR resources. Propose how timely reports will be made to DSMBs, the Steering Committee, and other relevant oversight and regulatory bodies. Detail how privacy and security of all patient information as well as access by controlled authorization will be ensured. Describe how investigators could be assisted during their preparation of abstracts and manuscripts and how the publications would be tracked. Justify the proposed budget and personnel requested. Since human somatic cell transplantation involves the administration of materials of biological products, it is regulated by the Center for Biologics Evaluation and Research (CBER), FDA. IND applications are filed concerning clinical use of such products. Respondents to this RFA should convey their familiarity with such requirements for clinical, pre-clinical and animal studies. CBER has prepared documents relevant to this RFA that include: Information on Submitting an Investigational New Drug Application, including cGMP and GLP, for a Biological Product available at: http://www.fda.gov/cber/ind/ind.htm PANCREATIC ISLET SPECIFIC DOCUMENTS Dear Colleague Letter to Transplant Centers: Allogeneic Pancreatic Islets for Transplantation (9/2000) available at: http://www.fda.gov/cber/ltr/allpan090800.pdf Transcript of discussion of allogeneic pancreatic islets by FDA Biologic Response Modifier Advisory Committee (3/20-21/2000) available at: http://www.fda.gov/ohrms/dockets/ac/cber00.htm PROPOSED AND FINAL RULES IMPACTING HUMAN ISLETS FEDERAL REGISTER Establishment Registration and Listing for Manufacturers of Human Cellular and Tissue-Based Products; Final Rule (1/2001) available at: http://www.fda.gov/cber/rules/frtisreg011901.pdf FEDERAL REGISTER Current Good Tissue Practice for Manufacturers of Human Cellular and Tissue-Based Products; Inspection and Enforcement; Proposed Rule (1/2001) available at: http://www.fda.gov/cber/rules.htm#gtp CELL/TISSUE BASED DOCUMENTS "Guidance for Industry: Guidance for Human Somatic Cell Therapy and Gene Therapy" (1998)available at: http://www.fda.gov/cber/gdlns/somgene.pdf "Points to Consider in the Characterization of Cell Lines Used to Produce Biologicals" (1993) available at: http://www.fda.gov/cber/gdlns/ptccell.pdf "Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use" (1997) available at: http://www.fda.gov/cber/gdlns/ptc_mab.pdf Application of GMP to Gene Therapy Products Used in Clinical Trials (5/31/2000) http://www.fda.gov/cber/summaries/malarkey053100.ppt Copies of Points to Consider documents are available from: The Division of Congressional and Public Affairs CBER HFM-12 1401 Rockville Pike, Suite 200 N Rockville, MD 20852-1448 Telephone: (301) 594-0830 CBER staff members are also available to respond to questions at (301) 594-0830. BUDGET AND RELATED ISSUES Applicants should complete the budget information as directed in the PHS 398 application form. Allowable costs In order to fully achieve the goal of this initiative, an award of up to $700,000 total direct costs will be awarded annually to the ABCC for support of administrative and bioinformatics activities. Applications should present five budget periods of 12 months each that provide adequate budget justification for all applicable direct and F&A costs. An estimate of personnel costs needs, including the principal investigators, other professional and support staff must be included. A minimum effort of 0.25 FTE is required for the ABCC Director. Estimates of travel costs to Steering Committee and Data Committee meetings as well as a statement that indicates a willingness to participate in these meetings must also be included. APPLICATIONS NOT CONFORMING TO THESE GUIDELINES WILL BE CONSIDERED UNRESPONSIVE TO THIS RFA AND WILL BE RETURNED WITHOUT FURTHER REVIEW The RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. 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. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: https://grants.nih.gov/grants/funding/phs398/label-bk.pdf. Submit a signed, typewritten original of the application, including the Checklist, and three signed photocopies, in one package to: Center for Scientific Review National Institutes of Health Two Rockledge Centre, Room 1040-MSC7710 6701 Rockledge Drive Bethesda, MD 20892-7710 (or Bethesda, MD 20817 if express mail or courier service is used) At the time of submission, two additional copies of the application must be sent to the Director, Office of Review, NCRR, at the address listed under INQUIRIES. Applications must be received by February 22, 2002. If an application is received after this date it will be returned to the applicant without review. The Center for Scientific Review (CSR) 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. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of an application already reviewed, but such applications must include an Introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the Center for Scientific Review and for responsiveness by NCRR. Applications that are incomplete or non-responsive will be returned to the applicant without further consideration. Applications must adhere to the page limitations and Special Application Requirements noted under the section APPLICATION PROCEDURES above to be considered responsive. 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 Office of Review, NCRR in accordance with the review criteria stated below. As part of the initial merit review, all applications will receive a written critique and may undergo a process in which only those applications deemed to have the highest merit, generally the top half of the applications under review, will be discussed, assigned a priority score, and receive a second level review by the National Advisory Research Resources Council. Review Criteria The goals of NIH-supported research are to advance understanding of biological systems, improve the control of disease, and enhance the health of humankind. The scientific and technical merits of the proposed activities and the organizational plans for participating in this cooperative agreement and the extent to which they address the overall goals and objectives of the RFA will be reviewed. ABCC applicants will be evaluated on the basis of: Responsiveness and innovative approaches to major objectives of this RFA; Prior experience in organizing and oversight of multi-centered basic and translational research studies and plans to extend this to the ICRs; Planned organization, oversight and administration of the ICR Program; Knowledge and experience in clinical trial oversight and cGMP and GLP compliance regulations Plans to coordinate ICR activities and to make ICR cores and resources available to other ICRs and NIH-supported investigators; Adequacy of ancillary facilities and equipment; Evidence of institutional support; Adequacy of the biostatistical and data acquisition/storage methods to be used; Integration of ABCC efforts with bioinformatics cores located within ICR institutions. Availability of computer technologies and equipment suitable for ICR oversight; Qualifications of personnel; Letters of planned or existing collaboration; Letters of reference from principal investigators who have participated in multi-center basic research or clinical research trial overseen by the ABCC applicant. ABCC applications will also be evaluated with regard to the likelihood that they will function in a synergistic manner and interact well with the other proposed components. Appropriateness of their proposed budgets will also be considered. In addition to the above criteria, in accordance with NIH policy, all applications will be reviewed with respect to the following: The adequacy of plans to include, recruit and retain both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research. The adequacy of the proposed protection for humans, animals or the environment, to the extent they may be adversely affected by the project proposed in the application. The training course(s) taken by key personnel addressing the protection of human subjects must be included in the application. For this purpose, key personnel are defined as individuals who design or conduct clinical research protocols. A discussion of data safety monitoring must also accompany the application. Schedule Letter of Intent Receipt Date: January 7, 2002 Application Receipt Date: February 22, 2002 Peer Review Date: March-April 2002 Council Review: May 16, 2002 Anticipated Award Date: July 2002 AWARD CRITERIA Factors that will be considered in making awards include: a) the administrative and scientific merit of the proposed program as determined by peer review in addition to the quality of the response to the requirements stated in this RFA; b) relevance to the overall programs and priorities of NCRR, c) compatibility of the features proposed in the plan with the qualifications of the applicant; and d) the availability of funds. The earliest anticipated date of award is July 2002. The award will be subject to administrative review by NCRR staff upon receipt of each annual non-competitive renewal application. INQUIRIES Inquiries concerning this RFA are encouraged. We welcome the opportunity to clarify any issues or respond to questions from potential applicants. Direct inquiries regarding programmatic issues to: Richard A. Knazek, M.D. Medical Officer Division of Clinical Research National Center for Research Resources One Rockledge Centre, Room 6030 6705 Rockledge Drive, MSC 7965 Bethesda, MD 20892-7965 Telephone: (301) 435-0792 FAX: (301) 480-3661 Email: richardk@ncrr.nih.gov Direct inquiries regarding review issues to: Charles H. Hollingsworth, Dr.P.H. Director, Office of Review National Center for Research Resources One Rockledge Centre, Room 6018 6705 Rockledge Drive, MSC 7965 Bethesda, MD 20892-7965 Telephone: (301) 435-0806 FAX: (301) 480-3660 Email: charlesh@ncrr.nih.gov Direct inquiries regarding fiscal matters to: Ms. Mary Niemiec Section Grants Management Officer Office of Grants Management National Center for Research Resources One Rockledge Centre, Room 6086 6705 Rockledge Drive, MSC 7965 Bethesda, MD 20892-7965 Telephone: (301) 435-0844 FAX: (301) 480-3777 Email: maryn@ncrr.nih.gov URLS IN NIH GRANT APPLICATIONS OR APPENDICES All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This RFA is related to all priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople/. 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 are provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the AMENDED "NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," https://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_20 01.htm, announced in the NIH Guide for Grants and Contracts on October 9, 2001: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02- 001.html. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community with this policy. The amended policy provides additional guidance on the analyses and reporting of analyses of sex/gender, racial/ethnic and relevant subpopulation differences in intervention effects for NIH- defined Phase III clinical trials. 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 NIH, unless there are clear and compelling scientific and ethical reasons not to include them. This policy applies to all initial (Type I) 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: https://grants.nih.gov/grants/guide/notice-files/not98-024.html. Investigators also may obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at: https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm Applicants may wish to place data collected under this RFA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.333. Awards are made under authorization of the Public Health Service Act, Titles III and IV, Sections 301, 479, and 480, as amended, Public Laws 78-410 and 99-158, 42 U.S.C. 241, 287, and 287a, as amended, and administered under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CRF Part 74 and 92. 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 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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