Full Text RR-95-001 NATIONAL RESOURCE FOR TRANSGENIC ANIMALS NIH GUIDE, Volume 23, Number 38, October 28, 1994 RFA: RR-95-001 P.T. 34 Keywords: Animal Breed. & Facil., Scientific Preservation of Organs/Tissue National Center for Research Resources Letter of Intent Receipt Date: December 1, 1994 Application Receipt Date: January 25, 1995 PURPOSE The National Center for Research Resources (NCRR) invites applications to establish a "National Resource for Transgenic Animals," to be awarded competitively in Fiscal Year 1995. The primary objectives of this initiative are to (1) create a repository of embryos and embryonic stem (ES) cells of transgenic rats and mice, and (2) conduct research to perfect cryopreservation methods for these important animal species. This award will establish a resource center where embryos and ES cells are preserved, maintained (banked), and distributed; where transgenic rats and mice are produced on request from the maintained embryos and ES cells; and where research is conducted to improve cryopreservation techniques. 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), National Resource for Transgenic Animals, is related to the priority areas of immunology, reproductive biology, atherosclerosis, carcinogenesis, and infectious diseases. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (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, laboratories, hospitals, or medical centers. Applications from foreign institutions are ineligible for the center program mechanism. Applicant institutions must demonstrate an established research and resource base in areas related to the RFA. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators/Program Directors. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) Animal (Mammalian and Nonmammalian) Model, and Animal and Biological Materials Resource grant (P40). Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for an application submitted in response to the RFA may not exceed five years. The anticipated award date is September 30, 1995. Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the size of an award will vary also. However, applicants must limit their requests to no more than $350,000 (direct costs) for the initial budget period. Future budget period escalations should not exceed a four percent increase over the previous budget period. This RFA is a one-time solicitation. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. FUNDS AVAILABLE The estimated funds (total costs) available for the first year of support for this activity are approximately $500,000. It is anticipated that one new award for approximately $500,000 (total costs) will be made in FY 1995. RESEARCH OBJECTIVES Background An NCRR-sponsored conference on "Development of Transgenic Animal Model Resources" was held in November 1990. This conference recommended the development of transgenic technology and cryopreservation of transgenic embryos and sperm. Improved preservation of animal genetic resources through cryopreservation was also recommended in the 1990 Report of the Committee on Preservation of Laboratory Animal Resources, Institutes of Laboratory Animal Resources, Commission of Life Sciences, National Research Council. The NCRR announced RFA RR-93-002, "National Resource for Transgenic Animals" in FY 1993. As a result of that RFA, one award was made for a resource grant concerning transgenic and targeted mouse mutant preservation. Since the time of the above referenced reports, rapid progress has been made in developing the technology necessary for production of other transgenic animals and transgenic tissue. Many of the studies have involved mice, primarily because of the extremely high level of genetic characterization of this species. Comparatively, the genetic characterization level of rats is considerably lower. Despite this factor, and considering the developed technology, unique advantages may accrue with further development of rat transgenic models; thus, a goal of this RFA is to extend the NCRR initiative for resources for transgenic animals to include transgenic rats. Basically, the four major reasons for such a development are: 1. The expression of a gene in one species may not give phenotypic expression in another. For example, the genes controlling osteoarthritis show no phenotypic expression in the mouse, but do in the rat. 2. Some disease states are better defined in rats than in mice. For example, the steroid hormone induction of mammary cancer is well known in the rat, but not in the mouse. Similarly, behavioral paradigms have been established in rats, but are difficult to study in mice. 3. There is often better control of reproductive events in rats. Recovery of sperm, oocytes and embryos is comparatively easy. Rats require unique methods of gonadotropin administration, but are larger than mice and more convenient for some studies. 4. Finally, the larger body size of rats may provide unique advantages for animal model development. Objectives The objective of this RFA is to initiate a long-term, stable, program for safeguarding national animal research resources of importance to biomedical research. This initiative will: 1. Provide support to a center with capabilities to serve as a multi-categorical research and service resource for the preservation and supply of both transgenic rats and mice. The center is to serve biomedical research users throughout the United States. 2. Encourage applied research on the development of improved techniques for cryopreservation of eggs, sperm, and embryos of rats and mice and utilization of ES cells. 3. Incorporate the resources/equipment for the freezing and maintenance of embryos, ES cells, sperm, and eggs of transgenic rats and mice, and provide live animals on a full-cost recovery basis. A plan must be presented that describes the cost recovery procedures to be implemented. 4. Provide a means for extensive, long-term support to maintain the embryos and ES cells of those rat and mouse species and models considered to be of national importance, and which cannot be preserved through alternate methods. 5. Establish a national advisory committee to review, plan, and prioritize national needs for preservation of important laboratory animal resources. This committee will also act as a central point for the review and evaluation of stocks to be accepted into the repository. It is suggested that the committee be composed of no fewer than five members, with the principal investigator serving as the chairperson of the committee. A minimum of two members from outside the grantee institution should be appointed. The committee should meet formally at least twice a year during the first year, and at least once a year thereafter. Committee conference telephone calls should be held on an as-needed basis to coordinate and plan the activities of the center. 6. Establish effective cooperation with other institutions and organizations with similar interests to minimize costs and avoid duplication. 7. Establish a modern database for: classification of all rat and mouse embryos and ES cells maintained by the resource; maintenance of nomenclature for transgenic embryos and ES cells being held; and tracking distribution of all embryos, ES cells, or animals provided to users of the resource. 8. Encourage users who have developed transgenic animals with research funds provided through the extramural programs of the National Institutes of Health (NIH) to store constructs in the center. 9. Encourage complete budgetary self-sufficiency of the center by the end of its project period. A detailed plan should be presented which describes how such self-sufficiency will be achieved. For purposes of this RFA, users of the center are defined as those individuals who have active peer-reviewed research projects involving transgenic animals, with highest priority given to those funded by the extramural programs of the National Institutes of Health, followed by those funded by other agencies of the U.S. Public Health Service, then by those funded by other sources of peer-reviewed research support. LETTER OF INTENT Prospective applicants are asked to submit, by December 1, 1994, 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 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 is helpful in planning for the review of applications. It allows 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: Director, Laboratory Animal Sciences Program National Center for Research Resources Westwood Building, Room 857 Bethesda, MD 20892 Telephone: (301) 594-7933 FAX: (301) 594-9149 APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research; 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; and from the program administrator listed under INQUIRIES. Budgetary Considerations - Allowable Costs Unless otherwise indicated, allowable costs and policies governing the research grant programs of the NIH will prevail. It is expected that most equipment necessary to carry out this work will already be available. However, requests for major equipment under this RFA will be considered. This would include, but not be limited to, equipment for producing and maintaining (freezing) transgenic rat and mouse embryos, ES cells, ova, and sperm. While costs of animal maintenance (i.e., per diem charges) for research animals are allowable, it is expected that the costs of production of live animals from transgenic embryos or ES cells will be recovered from the users through a cost recovery system. Applicants should separately identify all costs related to the maintenance of research animals and to animal production. Applicants should budget for the consultant fees and travel expenses of the national advisory committee members who will meet throughout this period of grant support to advise on center activities. The RFA label available in the PHS 398 (rev. 9/91) 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 and the YES box must be marked. Submit a signed, typewritten original of the application, including the Checklist, and three signed photocopies in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two additional copies of the application must be sent to: Comparative Medicine Review Committee Office of Review National Center for Research Resources Westwood Building, Room 10A16 Bethesda, MD 20892 Applications must be received by close of business January 25, 1995. If an application is received after that date, it will be returned to the applicant without review. 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. The DRG 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 the DRG and responsiveness by the NCRR. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Only those applications that propose an integrated resource including both mice and rats will be considered responsive. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit in accordance with the review criteria stated below, by an appropriate peer review group convened by the NCRR. 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 noncompetitive 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 noncompetitive will be withdrawn from further consideration and the principal investigator/ program director and the official signing for the applicant organization will be notified. Review Criteria The initial review of the grant applications will focus on scientific merit and be based on the following criteria: 1. Overall Program o The potential of the center to meet the objectives stated in this RFA. An application must describe how all objectives outlined in this RFA will be met. o The scientific merit of the program as a whole, including the significance of the overall program goals and the development of a well-defined central focus. o The potential of the identified participants to develop research programs of high scientific merit as evidenced by previous accomplishments. 2. Administration and Planning o The scientific and administrative leadership ability and experience of the Principal Investigator and his/her commitment and ability to devote adequate time to the effective management of the center. o The composition of the advisory committee, and how the national needs for preservation of the laboratory animal resources will be reviewed, planned, and prioritized. o Maintenance of internal communication and cooperation among the investigators involved in the center, and adequacy of plans for such collaboration. o Appropriateness of the budget for the various components of the grant. o Appropriateness of the plan that details full-cost recovery for production of live rats and mice from embryos or ES cells. o Appropriateness of the plan that describes how the resource will achieve budgetary self-sufficiency by the end of the project period. o Quality of the plan to develop a database that will classify all rat and mouse embryos and ES cells maintained by the resource; maintain nomenclature for the transgenic embryos and ES cells being held; and track distribution of all embryos, ES cells, or animals sent to users of the resource. 3. Scientific Expertise of Key Personnel o Quality and appropriateness of expertise available for research on the development of improved cryopreservation techniques, maintenance of animals, and development of the database. o Nature and degree of interdisciplinary approach for promoting collaboration among scientists with expertise in transgenic animal methodology. o Qualifications, experience, and evidence of the commitment of the investigators within the applicant institution, and their willingness to interrelate with other elements proposed for the center. 4. Institutional Commitment o The institutional commitment to the program, including lines of responsibility for the proposed center and the institution's contribution to the management capabilities of the center. o The degree of institutional contributions for administrative and planning activities. o The research environment and the availability of expertise, resources, equipment, and space for the freezing and maintenance of rat and mouse embryos, ES cells, sperm, and ova of transgenic animals. o The availability of expertise and resources required to provide users with live animals from embryos or ES cells, at their request. o The potential for interaction with scientists from other departments and institutions to minimize costs and avoid duplication. o The institutional commitment to any newly-recruited individuals responsible for conducting essential grant functions and activities. In compliance with NIH policy and usual practice, the initial review group will also examine the provisions for the protection of animal subjects and the safety of the research environment. Following the initial scientific merit review, competitive applications will receive a second-level review by the National Advisory Research Resources Council. AWARD CRITERIA Applications will compete for available funds with all other applications submitted in response to this RFA and recommended by peer review. The following factors will be considered in making funding decisions: o Quality of the application as determined by peer review o Availability of funds o Overall program balance represented by the applications recommended by peer review Schedule Letter of Intent Receipt Date: December 1, 1994 Application Receipt Date: January 25, 1995 Initial Review: June 1995 Second Level Review: September 1995 Anticipated Date of Award: September 30, 1995 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: Director, Laboratory Animal Sciences Program Comparative Medicine Program National Center for Research Resources Westwood Building, Room 857 Bethesda, MD 20892 Telephone: (301) 594-7933 FAX: (301) 594-9149 Email: LeoW@EP.NCRR.NIH.GOV Direct inquiries regarding fiscal matters to: Mr. Paul Karadbil Grants Management Office National Center for Research Resources Westwood Building, Room 853 Bethesda, MD 20892 Telephone: (301) 594-7955 FAX: (301) 594-7910 Email: PaulK@EP.NCRR.NIH.GOV AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.306, Laboratory Animal Sciences and Primate Research. Awards are made under authorization 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 52 and 45 CFR Parts 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The Public Health Service (PHS) strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco produces. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. .
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