DATABASE MANAGEMENT OF NIH-SUPPORTED CHIMPANZEES Release Date: May 25, 1999 RFA: RR-99-006 Update: The following update relating to this announcement has been issued: August 3, 2010 - This RFA has been reissued as (RFA-RR-10-008). National Center for Research Resources Letter of Intent Receipt Date: June 18, 1999 Application Receipt Date: July 21, 1999 PURPOSE The Comparative Medicine Area of the National Center for Research Resources is issuing this Request for Applications (RFA) to encourage the submission of applications to create, develop and maintain a chimpanzee database for biomedical research purposes. In 1986, NIH established five chimpanzee breeding colonies in order to have an adequate supply of these animals available for biomedical research purposes. Based on the recommendations in a report from the National Academy of Sciences, NCRR has created a NIH Chimpanzee Management Program (ChiMP). One of the key elements of the NIH ChiMP is the accumulation of individual animal histories into a single, accessible database. The database will contain the genealogy, clinical, and experimental information as well as other relevant statistics on every animal within the NIH-supported facilities. 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, Database Management of NIH- Supported Chimpanzees, is related to several priority areas, including AIDS, other infectious diseases, cancer heart disease and stroke, diabetes and chronic disability conditions, maternal and infant health, and others. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal Government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT The administrative and funding instrument to be used for this program will be a cooperative agreement (U24), an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during 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. The total project period for an application submitted in response to this RFA may not exceed five years. The anticipated award date is March 2000. This RFA is a one-time solicitation. FUNDS AVAILABLE The estimated funds (total costs) available for the first year of support for the entire program is $750,000. It is anticipated that there will be one cooperative agreement awarded. PROGRAM GOALS AND SCOPE The NIH recognizes the need to ensure a continued resource of chimpanzees for use in biomedical and behavioral research. It is important that an adequate supply of chimpanzees be maintained to develop and test preventive and therapeutic strategies for hepatitis, malaria and AIDS, including candidate vaccines and drug treatments, and for other critical health issues. The overall objective of this program is to provide specialized research resources (physical facilities, technology, professional and technical expertise) for investigators who require chimpanzees for research examining human health problems. In conjunction with maintaining a research population, the NIH recognizes the value of developing and maintaining a database for the NIH- supported animals. The database will contain information on every animal"s history and will serve as a resource to the biomedical research community. The major features of this database are as follows: o First and foremost, the database must be accessible to and interactive with prospective investigators proposing to utilize chimpanzees in approved experimental protocols. o The database must be also interactive and contain the records for each NIH- supported chimpanzee at the designated Chimpanzee Biomedical Research Colonies (CBRCs). The database should contain the genealogy of each chimpanzee at the CBRC facilities. o Summaries of general clinical histories should be maintained as part of the animal records. Routine clinical observations (raw data) will be maintained only at the CBRC. o Involvement in experimentation must be documented. Specific experimental protocols will not be part of the database. However, documentation of exposures to infectious diseases, etc., and organ, tissue manipulation (splenectomy, etc.) must be part of the animals" records. o The application should describe who is responsible for the input of the various types of data, and who is responsible for the validity of the data entered. SPECIAL REQUIREMENTS Terms and Conditions 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 Grant Administration policy statements. The administrative and funding instrument used for this program is the Cooperative Agreement (U24), 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 awardee for the project as a whole, although specific tasks and activities in carrying out these activities will be shared between the awardee, the CBRC Directors, and the NIH ChiMP Office Directors. 1. Awardee Rights and Responsibilities Awardee will have primary and lead responsibilities for the project as a whole, including data collection, quality control, final data analysis and interpretation, preparation of reports. The database will contain the genealogy, clinical, and experimental information as well as other relevant statistics on every animal within the NIH-supported facilities. In addition, the database must be accessible to and interactive with prospective investigators proposing to utilize chimpanzees in approved experimental protocols. Collaboration with the Directors of the NCRR-supported Chimpanzee Biomedical Research Colonies, and interactions with the Director, ChiMP Office/NCRR, is required. Applicants will collaborate and share data freely with the chimpanzee colony grantees, and the Director of the NCRR ChiMP Office, as well as to be able and willing to share data and communicate with the NCRR in an internet environment. However, awardees will retain custody of and have primary rights to the data developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH. 2. NIH Chimpanzee Management Program (ChiMP). The Director of the NIH ChiMP Office will serve as the ChiMP Coordinator. The ChiMP 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. The ChiMP Coordinator will be involved in the selection process of appropriate animals for research, ensure that there is collection of pertinent clinical information on the animals in experimental protocols, and monitor the data input into the database. The ChiMP Coordinator will also ensure that all protocols have been reviewed and approved by the Interagency Animal Models Committee prior to experimentation. 3. Advisory Panel Based on the information obtained, a working group of nongovernment experts from the National Advisory Research Resources Council (NARRC) will make recommendations to the ChiMP Coordinator and advise on long-term plans for research use, breeding colony size, demographics, genetics, and genetic management as well as long-term care. 4. Arbitration Any disagreement that may arise on scientific/programmatic matters (within the scope of the award), between award recipient and NCRR may be brought to arbitration. An arbitration panel will be composed of three members -- one selected by the Advisory Panel (with the NCRR member not voting) or by the individual awardee in the event of an individual disagreement, a second member selected by NCRR, and the third member selected by the two prior selected members. This special arbitration procedure in no way affects the awardee"s right 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. LETTER OF INTENT Prospective applicants are asked to submit, by June 18, 1999, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel, collaborators and their activities, and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allow NCRR staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be sent to: John Strandberg, D.V.M., Ph.D. Comparative Medicine National Center for Research Resources 6705 Rockledge Drive, Room 6030 Bethesda, MD 20892 Telephone: (301)435-0744 FAX: (301)480-3819 Email: firstname.lastname@example.org APPLICATION PROCEDURES To promote the development of a collaborative program among the award recipient and the chimpanzee colony grantees, a number of issues need to be addressed in the application. Applicants must include their specific plans for responding to the "Terms and Conditions of Award" section. Applicants should detail the specialized or unique facilities, fundamental infrastructure, and core resources and services that are available to support and manage the database, and should propose any additional equipment, specialized programming, and personnel requirements needed to participate in the cooperative group. If facilities at more than one institution are required, applicants should thoroughly describe them. Applicants should describe the personnel and the computer hardware and software available, and should propose additional needs related to the proposed cooperative group activities. The roles and expertise of all key personnel, collaborators, and consultants who are associated with the application should be well documented. Each applicant should describe his/her plans for interfacing with the NIH ChiMP Office and the Chimpanzee Colony grantees and should propose his/her views on how the NIH ChiMP Office and chimpanzee colony grantees activities should be carried out in the context of the Awardee Rights and Responsibilities described above. Applicants should state their willingness to collaborate and share data freely with the chimpanzee colony grantees, and the Director of the NCRR ChiMP Office, as well as to be able and willing to share data and communicate with the NCRR in an internet environment. Applicants should also describe how they will comply with the decisions of the Advisory Panel to the ChiMP Office, and how they will fulfill the responsibility to work together cooperatively. Applicants should submit budget requests that include travel to required grantee meetings and/or telephone conferences. The awardee will meet with the NIH ChiMP Office Director and the Chimpanzee Colony Directors at least once yearly and should include travel funds in budget requests. The research grant application form PHS 398 (rev. 4/98) is to be used in applying for this award. These forms are available at most institutional offices of sponsored research, from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/453-0714, e-mail: email@example.com, and from the program administrator listed under INQUIRIES. The RFA label available in the PHS 398 (rev. 4/98) application form must be affixed to the bottom of the face page of the application. 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 2a of the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application, including the Checklist and appendices, and three signed, photocopies, in one package to: CENTER FOR SCIENTIFIC REVIEW NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040-MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must be sent to: John Strandberg, D.V.M., Ph.D. Comparative Medicine National Center for Research Resources 6705 Rockledge Drive, Room 6030 Bethesda, MD 20892 Telephone: (301) 435-0744 FAX: (301) 480-3819 Email: firstname.lastname@example.org Applications must be received by July 21, 1999. If an application is received after that 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 applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by CSR and responsiveness by NCRR 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 NCRR in accordance with the review criteria stated below. As part of the initial merit review, a streamlining process may be used in which applications receive a written critique and under a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed, assigned a priority score, and receive a second level by the National Advisory Research Resources Council. REVIEW CRITERIA Applicants are encouraged to submit and describe their own ideas about how best to meet the goals of the cooperative study and are expected to address issues identified under SPECIAL REQUIREMENTS of the RFA. The review group will assess the technical merits of the proposal and other related factors including: o scientific, technical, or medical significance and originality of proposed database facilities, o interactive capability of the proposed database, such as data input from chimpanzee colonies, search capabilities for investigators, and reporting analyses from NIH ChiMP Office, o appropriateness and adequacy of the procedures and methods proposed for inputting, maintaining and accessing the animal records, o qualifications and experience of the Principal Investigator and staff, o availability of the database and protocol procedures for accessibility in order to identify specific information necessary to utilize chimpanzees for research purposes, o database compatibility with year 2000 issues, o provisions for the protection of human and animal subjects data and the safety of the working environment, o demonstrated willingness to work as part of ChiMP and collaborate with the NCRR Director of the NIH ChiMP Office, AWARD CRITERIA Applications recommended by the National Advisory Research Resources Council will be considered for award based upon (a) scientific and technical merit, (b) program balance, and (c) availability of funds. Letter of Intent Receipt Date: June 18, 1999 Application Receipt Date: July 21, 1999 Review by NARRC: January 2000 Anticipated Award Date: March 2000 INQUIRIES 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: John Strandberg, D.V.M., Ph.D. Comparative Medicine National Center for Research Resources 6705 Rockledge Drive, Room 6030 Bethesda, MD 20892-7965 Telephone: (301)435-0744 FAX: (301)480-3819 Email: email@example.com Direct inquiries regarding fiscal matters to: Ms. Joellen Harper Office of Grants Management National Center for Research Resources 6705 Rockledge Drive, Room 6086 Bethesda, MD 20892-7965 Telephone: (301)435-0844 Email: firstname.lastname@example.org AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.306. 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 NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR 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 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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