NATIONAL STEM CELL RESOURCE Release Date: December 23, 1998 RFA: RR-99-002 P.T. National Center for Research Resources Letter of Intent Receipt Date: February 11,1999 Application Receipt Date: March 11, 1999 PURPOSE The purpose of this Request for Applications (RFA) is to solicit applications to establish a National Stem Cell Resource. The resource will be for deposit, maintenance, preservation and distribution of nonhuman-derived embryonic and other stem cells from a variety of species, as well as for deposit and distribution of related reagents and information in order to make these critical research tools available for biomedical research. 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, National Stem Cell Resource, is related to several priority areas, including 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 This RFA will use the National Institutes of Health (NIH) animal model and animal and biological material resource grant (P40) mechanism. 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 this RFA may not exceed 5 years. The anticipated award date is December 1, 1999. 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. This RFA is 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 Approximately $700,000 (including direct and indirect costs) will be available for this initiative in Fiscal Year 2000 and for each subsequent year. It is anticipated that one award will be made. Proposed funding levels are subject to change due to budgetary, administrative and/or scientific considerations, and are dependent upon the receipt of a sufficient number of applications of high scientific merit. The award of grants pursuant to this RFA is contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES Background Embryonic stem cells and other stem cell precursors for differentiated tissues are critical models for fundamental understanding of biological and disease processes. Embryonic stem cell research is important to provide the tools for studies of basic mechanisms of development and function, in functional genomics, and in production of transgenic animals. The ability to control differentiation and sort differentiated cells from undifferentiated, and possibly tumorigenic precursor stem cells, holds great potential for therapeutics, particularly involving tissue replacement. Many laboratories are now engaged in research using mouse embryonic stem cells and lineage-specific precursors derived from embryonic stem cells. In addition, embryonic stem cells are being isolated and developed in such widely used and important model systems as nonhuman primate, zebrafish and chicken. As stem cells are isolated from different species, and stem cell precursors for differentiated cell types are characterized and isolated, it will be critical that these resources are not lost, but are made available from a centralized source for use in studies of biology, disease, and therapies. To ensure that invaluable stem cells are available to the research community, a National Stem Cell Resource will collect, maintain, preserve and distribute nonhuman embryonic, transgenic and lineage-specific stem cells from a variety of species. In addition, the Resource will be a focal point for exchange of reagents directly related to the characterization of the stem cells on deposit (specific antibodies or nucleic acid probes, for example). Other Features of the Resource Plans for the National Stem Cell Resource must incorporate features that will enable the resource to acquire, preserve, maintain, and distribute stem cells and directly related reagents for the biomedical research community. An Advisory Committee must be established to advise on policy for acquisition, distribution, de-accessioning and general functions of the resource. Plans must include a database component to collect and distribute information about the Resource to the research community; this information component must be available through the World Wide Web and allow researchers to determine what resources are available and how to obtain them. Furthermore, this component should be designed as a critical focal point for information exchange for research using the cells and reagents in the Resource. Because the Resource is expected to collect and distribute cells from a variety of nonhuman animal models, plans to accommodate the specific needs for growth, preservation, expansion, and distribution of stocks from these various sources will be an important part of the project. The application for this Resource must also put forward a clear plan for cost recovery from investigators acquiring materials from the Resource, and clear plans for how that program income will be used. Furthermore, the application should demonstrate institutional support for this resource, including, at a minimum, a letter from the institutional official with authority for the space and time of the Principal Investigator. SPECIAL REQUIREMENTS A requirement under the P40 mechanism is that research related to improvement of the Resource must be proposed. Examples of such research would be investigations into optimal methods for cryopreservation of cell stocks, or investigations into reagents to characterize and identify stem cells of various types. These are examples, only, and are not intended to be limiting. The Principal Investigator for the Resource is expected to attend the annual meeting of resource directors for Comparative Medicine area, NCRR, resources, to be held at one of the resources. The application should include a budget item for this expense, calculated on a two-day meeting. The application must include a plan to track users and the general types of projects the Resource materials are used in on a calendar-year basis. Users include both investigators depositing materials and investigators ordering the materials. These results must be reported to the Program Director, NCRR, on a yearly basis to show activity of the Resource with respect to materials deposited and who has used the materials from the resource. LETTER OF INTENT Prospective applicants are asked to submit, by February 11, 1999, a letter of intent that includes a descriptive title of the proposed project, 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 this RFA. 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 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: Jill L. Carrington, Ph.D. Comparative Medicine National Center for Research Resources 6705 Rockledge Drive, Room 6164 Bethesda, MD 20892 Telephone: (301) 435-0744 FAX: (301) 480-3819 Email: jillc@ncrr.nih.gov APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 4/98) is to be used in applying for this grant. These forms are available at most institutional offices of sponsored research; from the Division of Extramural Outreach and Information Resources, NIH, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301) 710-0267, Email grantsinfo@nih.gov; and from the program administrator listed under INQUIRIES. The RFA label available in the PHS 398 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 2 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 three signed, photocopies, in one package to: CENTER FOR SCIENTIFIC REVIEW NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, SUITE 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: Jill L. Carrington, Ph.D. Comparative Medicine National Center for Research Resources 6705 Rockledge Drive, Room 6164, MSC 7965 Bethesda, MD 20892 Bethesda, MD 20817 (for express/courier service) Applications must be received by March 11, 1999. If an application is received after that date, it will be returned to the applicant without 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 the NCRR. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with NIH peer review procedures. 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 scientific merit, generally the top one half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the National Advisory Research Resources Council, NCRR. Review Criteria The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. o Significance. What will be the impact of this resource on biomedical research? o Approach. Is the resource designed to effectively provide a service to the research community? Will the database support research by providing important information about the Resource materials to the research community? o Innovation. Are the design of the resource and the method of providing service innovative? o Need. Is there a demonstrated need for the resource in the biomedical research community? o Investigator. Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? o Research Component. Is the research to be performed of value to the resource? Is the research innovative and significant? o Environment. Does the environment contribute to the probability of success of the resource? Is there evidence of institutional support for the resource? The initial review group will also examine the provisions for the protection of human and animal subjects and the safety of the research environment, as well as the appropriateness of the budget. AWARD CRITERIA Applications will compete for available funds with all other applications submitted in response to this RFA. The following will be considered when making funding decisions: o Quality of the proposed project as determined by peer review o Availability of funds o Program balance among research areas 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: Jill L. Carrington, Ph.D. Comparative Medicine National Center for Research Resources 6705 Rockledge Drive, Room 6164 Bethesda, MD 20892 Telephone: (301) 435-0744 FAX: (301) 480-3819 Email: jillc@ncrr.nih.gov 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: jh41m@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.849. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke- free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.
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