NATIONAL STEM CELL RESOURCE Release Date: December 13, 1999 RFA: RR-00-001 National Center for Research Resources Letter of Intent Receipt Date: January 9,2000 Application Information Meeting: January 20, 2000 Application Receipt Date: February 24, 2000 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, banking, growth and distribution of postnatally- derived stem cells from a variety of species as well as embryonic stem cells from non-human species, and 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" at http://odphp.osophs.dhhs.gov/pubs/hp2000. 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. Foreign institutions are not eligible for P40 grants. 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 September, 2000. 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 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 NCRR intends to commit approximately $800,000 in FY 2000 to fund one new grant in response to this RFA. An applicant may request a project period of up to 5 years. 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 applications of outstanding scientific and technical merit. RESEARCH OBJECTIVES Background Embryonic stem cells and other stem cell precursors for differentiated tissues are critical models for fundamental understanding of normal 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 genetically altered 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 in such widely used and important model systems as the nonhuman primate, zebrafish, medaka and chicken. Furthermore, there have been significant advances in the characterization and isolation of stem cells derived from postnatal tissues and which have the potential to form replacement tissues for the central nervous system, muscle, blood, and other organs. This area of research, with its potential for therapeutic use, will require ready accessibility of stem cells to understand their developmental potential and the control of that potential. Reagents to characterize these precursor cells and that can be used to recognize and sort them from living tissue are becoming known and will be invaluable to research, as well as potentially valuable in tissue replacement efforts. As postnatally-derived and embryonic 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 materials are not lost, but are made available from a centralized resource 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 acquire, bank, grow and distribute postnatally-derived stem cells and nonhuman embryonic stem cells from a variety of species. The National Center for Research Resources currently supports a repository that receives and distributes mouse embryonic stem cells carrying targeted mutations. The National Stem Cell Resource should not duplicate these efforts. Rather, it should provide for sharing of postnatally-derived stem cells from a variety of species and enlarge the number of non-human species for distribution of embryonic stem cells (with and without targeted mutations). In order to more fully support stem cell research, and research into use of stem cells for replacement of diseased or damaged tissues, it is imperative that stem cell-specific reagents are also widely available to the research community. Therefore, the Resource will also 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 Advisory Committee: Plans for the National Stem Cell Resource must incorporate features that will enable the resource to acquire, bank, grow 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 and management of the collection, as well as on general functions of the resource and as described below. The Advisory Committee must be named in the application and be composed of individuals with outstanding scientific expertise and selected for national representation. Biographical sketches and letters from the committee members must be provided to demonstrate that the committee comprises the expertise necessary to perform these functions. Stem Cells from Postnatal Tissues: In the case of postnatally-derived stem cells, the resource must be prepared to do in vitro expansion and appropriate characterization of the cells for distribution. Furthermore, the resource must accommodate needs for optimizing methods for growth and preservation of these cells from varying tissue and species sources. The Advisory Committee will function to ensure that appropriate standards are used to provide the most useful cells to investigators. Non-human Embryonic Stem Cells: Except in the case of mouse, research on embryonic stem cells has generally not advanced to the point where chimerism and in vivo participation in formation of germline cells can be routinely shown for embryonic stem cells from each species. Further, such testing on a routine basis would involve prohibitive costs. Nevertheless, it is useful and important to make these cells and pertinent information for use of the cells available for research. This National Stem Cell Resource will not function to routinely perform in vivo testing for participation in formation of germline cells for embryonic stem cells of all species to be deposited and distributed within the initial grant period. Rather, the Resource must incorporate a plan to work through the Advisory Committee to determine the level of rigor with which deposited cells must be characterized to be of use to the research community. It is envisioned that investigators wishing to use the services of the Resource to distribute germline-capable, totipotent embryonic stem cells, will supply enough cells to meet anticipated demand. If the Resource accepts embryonic stem cells available in limited quantity and must expand the cells to accommodate widespread distribution, there must be a plan to characterize the cells according to reasonable Advisory Committee standards and to provide full documentation of the degree of characterization to investigators receiving the cells. Information Resources: Because the Resource is expected to collect and distribute cells from a variety of 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 must demonstrate that mechanisms will be in place for exchange of information for optimal growth and preservation of the cells from the investigators depositing the cells. 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. Other: The application for this Resource must put forward a clear plan for charges to investigators acquiring materials from the Resource, and clear plans for how program income will be used to enhance the Resource. Inquiries on this aspect of the application are welcomed by Program staff. SPECIAL REQUIREMENTS Under the P40 mechanism, research related to the improvement of the Resource activities 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 examples are not intended to be limiting. The Principal Investigator for the Resource is required to attend the annual meeting of resource directors for the Comparative Medicine area, NCRR, which is held at one of the Resources. The application should include a budget item for this expense, calculated as a two-day meeting. The application should demonstrate institutional support for this resource. The application must include a plan to document users and all Resource- related publications resulting from use of the Resource on a yearly basis, to be submitted with the annual progress report. Users include both investigators depositing materials and investigators ordering the materials. These results must be reported yearly to the Program Director, NCRR, to show activity of the Resource with respect to materials deposited and investigators who have used the materials from the resource, as well as to demonstrate the impact of the Resource on biomedical research. As research on embryonic stem cells grows, it may be that the level of rigor for routinely characterizing these cells in several species may approach that of the mouse, including testing for formation of germline cells in chimeric animals after initial cell populations are expanded in order for the stem cells to be useful for further investigation. It will be incumbent on the Resource to document such needs and incorporate a plan to meet any such needs in any competitive renewal, including collaborations with laboratories capable of performing the in vivo testing methods. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This 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 "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," which was published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18, 1994, available on the web at: http://grants.nih.gov/grants/guide/notice-files/not94-100.html. 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 the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) 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: http://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. LETTER OF INTENT Prospective applicants are asked to submit, by January 9, 2000, 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 One Rockledge Centre, Room 6174 6705 Rockledge Drive Bethesda, MD 20892 Telephone: (301) 435-0744 FAX: (301) 480-3819 e-mail: [email protected] 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 or E-mail [email protected], and from the program administrator listed under INQUIRIES. The RFA label available in the PHS 398 application form must have the RFA number on it and 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 the label and on line 2a of the face page of the application form and the YES box must be marked. The sample RFA label available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to allow for this change. Please note this is in pdf format. Submit a signed, typewritten original of the application, including the Checklist, and three signed, photocopies, in one package to: Center for Scientific Review (CSR) National Institutes of Health Suite 1040 6701 Rockledge Drive MSC 7710 Bethesda, MD 20892-7710 Applicants who wish to use express mail or courier service should change the zip code to 20817. 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 One Rockledge Centre, Room 6174 6705 Rockledge Drive, MSC 7965 Bethesda, MD 20892 (for express mail please use zip code 20817) Applications must be received by February 24, 2000. If an application is received after that date, it will be returned to the applicant without review. The 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 for responsiveness by the NCRR. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, CSR staff may contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next review cycle. Applications that are complete and responsive will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NCRR 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. Review Criteria o Significance. What will be the impact of this resource on biomedical research? Does the application demonstrate the breadth of research that will be impacted? o Approach. Is the resource designed to effectively provide the required service to the research community? Is the approach sufficient to accommodate the varied species and tissue sources of the cells? Will the database support research by providing important information about the Resource materials to the diverse research community? o Innovation. Are the design of the resource and the method of providing service innovative? 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? In addition to the above criteria, in accordance with NIH policy, all applications will be reviewed with respect to the following: o The reasonableness of the proposed budget and duration in relation to the proposed research. o 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. Schedule Letter of Intent Receipt Date: January 9, 2000 Application Receipt Date: February 24, 2000 Peer Review Date: April, 2000 Council Review: May, 2000 Earliest Anticipated Start Date: July 1, 2000 AWARD CRITERIA Award criteria that will be used to make award decisions include: o scientific merit (as determined by peer review) o availability of funds o programmatic priorities INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. An Applicant Information Meeting to assist applicants unfamiliar with the requirements for Animal Model, and Animal and Biological Materials Resource Grant applications and to clarify any issues or questions from potential applicants will be held at 1 P.M. on January 20, 2000 in Bethesda, MD. For additional information regarding the Applicant Information Meeting, call (301) 435-0744. A summary of the presentations and issues discussed will be made available on the NCRR web site (http://www.ncrr.nih.gov) for those unable to attend. Direct inquiries regarding programmatic issues to: Jill L. Carrington, Ph.D. Comparative Medicine National Center for Research Resources One Rockledge Centre, Room 6174 6705 Rockledge Drive Bethesda, MD 20892 Telephone: (301) 435-0744 FAX: (301) 480-3819 e-mail: [email protected] Direct inquiries regarding fiscal matters to: Mr. Paul Karadbil Office of Grants Management National Center for Research Resources 6705 Rockledge Drive, Room 6086 Bethesda, MD 20892-7965 Telephone: (301) 435-0844 Email: [email protected] 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 NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 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 come 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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