HUMAN EMBRYONIC STEM CELL RESEARCH RESOURCE INFRASTRUCTURE ENHANCEMENT AWARD Release Date: November 29, 2001 (see NOT-RR-03-003 and PAR-03-177) PA NUMBER: PAR-02-023 National Center for Research Resources (http://www.ncrr.nih.gov) National Institute of Aging (http://www.nia.nih.gov) National Institute of Child Health and Human Development (http://www.nichd.nih.gov) National Institute of Diabetes and Digestive and Kidney Diseases (http://www.niddk.nih.gov) National Institute of Mental Health (http://www.nimh.nih.gov/) Application receipt dates: January 8, 2002, March 8, 2002, May 8, 2002, July 8, 2002, and September 6, 2002. PURPOSE The purpose of this initiative is to increase the research resource capacity for basic research using human embryonic stem cells (hESC). The research projects proposed under this Program Announcement (PA) will address the expansion, testing, quality assurance, and distribution of existing cell lines that are in compliance with criteria for federal funding of research on existing hESC as described in http://grants.nih.gov/grants/guide/notice- files/NOT-OD-02-005.html. ELIGIBILITY REQUIREMENTS Applicants may apply only if they have hESC listed on the NIH Human Embryonic Stem Cell Registry, http://escr.nih.gov. Applications may be submitted by domestic and foreign, for-profit and not-for-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. For SBIR/STTR support, only institutions or organizations based in the United States or their affiliates with eligible hESC are eligible to apply. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT This PA will use both the National Institutes of Health (NIH) Resource- Related Research Projects (R24) award mechanism and the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) grant mechanisms. The SBIR and STTR applications received in response to this announcement will be considered for both Phase I and Phase II support. This PA must be read in conjunction with the current Omnibus Solicitation of the Public Health Service for Small Business Innovation Research (SBIR) and Small Business Technology Transfer(STTR)Grant Applications (PHS 2001-2, or after, January, PHS 2002-2.) The R24, SBIR and STTR mechanisms may be used to support research projects that will enhance the capability of resources to serve biomedical research. The total project period for an application submitted in response to this PA may not exceed 2 years. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. This PA may be reissued or additional PAs or Requests for Applications may be available in FY 2003 pending the availability of funds. FUNDS AVAILABLE It is anticipated that approximately $3 million total will be available in FY 2002. Award of grants is contingent upon the availability of such funds for this purpose. It is anticipated that up to 10 grants may be awarded under this program in FY 2002. The specific number to be funded will depend on the merit and scope of the applications received. Direct costs of awards made under the R24 mechanism are limited to $400,000 per year for each of the planned two years of support. Grants under the SBIR and STTR mechanisms may reach $750,000/year. Additional solicitations may be available in FY 2003 pending available of funds. Funding for the second year will be contingent on satisfactory progress during year 1. RESEARCH OBJECTIVES Background Embryonic stem cells uniquely proliferate in an undifferentiated state while retaining the capability to develop into the cell types derived from all three germ layers. Research suggests that mammalian embryonic stem cells have a potential for directed development that might allow for the replacement, or restoration, of cell and organ function. The recent development of hESC has been greeted as a first step in a process that holds promise for the restoration of cell or organ function in man. Substantial basic research on the characterization, mechanisms of differentiation, and regulation of cellular processes of hESC is essential before their potential in medicine can be assessed. This basic research requires supplies of cells that meet quality controls and behave reproducibly. The cells will need to be available in sufficient quantity for research and testing in multiple laboratories. hESC that are acceptable for research purposes are listed in the NIH Human Embryonic Stem Cell Registry http://escr.nih.gov. This initiative aims to enhance the availability of hESC for preclinical investigations. The development of quality controls to monitor the laboratory performance of the hESC lines is an integral part of the initiative. Scope of the Activity Costs allowed under this initiative will include: o Rental fees for laboratory space to support the expansion of existing hECS lines in compliance with good laboratory practices (GLPs) (21 CFR part 58). o Personnel costs for laboratory supervision, and maintenance of GLP cell culture procedures. Training of new laboratory technicians is allowed for the purposes of increasing skill levels to culture hECS. o Equipment including those needed for the expansion, quality assurance, storage, and distribution of hECS lines. Examples include: Centrifuges, biocontainment hoods, fume hoods, triple gas incubators, liquid nitrogen freezing and storage, -80oC freezers, water purification systems, balances, steam autoclaves, standard molecular biology instruments such as thermocyclers and gel electrophoresis apparatus, microscopes including those equipped for fluorescent in situ hybridization studies. o Supplies for standard cell culture including media, plates, flasks, growth factors and other nutrients, cell freezing, disposal, storage, and distribution materials. o Travel for the quality control certification of reagent vendors. Applicants are advised to budget for travel to attend an annual 2-day scientific and technical meeting in Bethesda, MD. o Development and support of a website that will make available information concerning the availability and properties of cell lines. Costs not allowed under this initiative: o Renovation, acquisition, or building of facilities. Activities that are encouraged under this initiative include: o Culture of existing cells sufficient to support the distribution of 250 or more aliquots of 20 million cells for each supported line per year for 2 years. o Characterization of hESC cell surface markers, DNA fingerprinting, and transcriptional profiling. o Karyotype, telomere, and fluorescent in-situ hybridization studies of cells at various passages. o Maintenance of frozen primary cell culture and "freeze-backs" from successive passages. o Development of sub-lines at various passages. o Development of cryopreservation techniques. o Xenografts into experimental animals to characterize hESC cell differentiation capabilities. o Application of vitrification techniques. o Quality assurance measures including studies of functionality after multiple freeze/thaw cycles, and sterility testing. o Development of technical support materials for researchers including laboratory instruction manuals and audio-visual resources. o Establishment of web-based instructional materials that describe the biological features of hESC. o Identification of optimal culture materials and conditions to maintain and expand hESC. This could include the development of human feeder cells and/or serum-free or serum substituted culture conditions. o Development of culture supplies to accompany the cells upon distribution to researchers. This may be achieved via sub-contracts with commercial suppliers of such materials. o Training in technical skills for laboratory use of hESC. o Development of a plan for cost recovery for resources supplied. Activities that are beyond the scope of this initiative and prohibited from support from this grant award include: o Derivation of new human embryonic stem cell lines from human blastocysts. o Research and development on stem cells from animals or other human sources. o Research to differentiate hESC. o Basic research on fundamental cellular and molecular mechanisms. o Animal transplantation studies with the exception of those described above. APPLICATION PROCEDURES The PHS 398 research grant application instructions and forms (rev. 5/2001) at http://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 301/435-0714, Email: GrantsInfo@nih.gov. The PA 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 Two Rockledge Center, 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. The Center for Scientific Review (CSR) will not accept any application in response to this PA 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 and responsiveness by NCRR. Applications that are incomplete or non-responsive will be returned to the applicant without further consideration. Applications that are complete and responsive to the PA 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, will be assigned a priority score, and receive an expedited second level review by the National Advisory Research Resources Council or other Boards or Councils as appropriate. Review Criteria The goals of NIH-supported research are to advance 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. The application will be reviewed primarily on the basis of the stated goals of the initiative: that is to expand the access to existing cell lines and provide high quality materials and information to the scientific community. (1) Significance: Does the proposed work enhance research resources for hESC? (2) Approach: Are the plans for research resource enhancement adequately developed, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? (3) Innovation: Will the project provide improved methodologies or knowledge to facilitate researcher use of the cell lines? (4) Investigator: Are the investigator and proposed personnel sufficiently knowledgeable, experienced, and 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 (if any)? (5) Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Is there evidence of institutional support? The reviewers will provide an administrative comment evaluating the adequacy and feasibility of the resource sharing plan. Recommendations regarding such plans are at http://www.ott.nih.gov/policy/rt_guide_final.html. This comment will not affect the priority score of the proposal. NIH staff will consider the adequacy of the plan in determining whether to recommend an application for award. The sharing plan as approved, after negotiation with the applicant as necessary, will become a condition of the grant award. SBIR/STTR Review Criteria: In addition to the above criteria applications for support under the SBIR/STTR programs will be assessed using the following criteria: o Does the proposed project have commercial potential to lead to a marketable product or process? o Are the aims original and innovative? Phase II Applications In addition to the above criteria, to what degree was progress toward the Phase I objectives met and feasibility demonstrated in providing a solid foundation for the proposed Phase II activity? Phase I/Phase II Fast Track Applications For Phase I/Phase II Fast Track applications, the following additional criteria will be applied: o Does the Phase I application specify clear, appropriate measurable goals (milestones) that should be achieved prior to initiating Phase II? o Did the applicant submit a concise Product Development Plan that adequately addresses the four areas described in Section VI, item G of this solicitation? o To what extent was the applicant able to obtain letters of interest, additional funding commitments, and/or resources from the private sector or non-SBIR/STTR funding sources that would enhance the likelihood for commercialization? o Does the project carry a high degree of commercial potential, as described in the Product Development Plan? In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: o The reasonableness of the proposed budget and duration in relation to the proposed activities o The adequacy of the proposed protection for laboratory staff working with the cells, animals or the environment, to the extent they may be adversely affected by the activities proposed in the application. AWARD CRITERIA Applications will compete for available funds with all other recommended applications. Award criteria that will be used to make award decisions include: o scientific merit (as determined by peer review)and, o availability of funds INQUIRIES Inquiries concerning this PA are encouraged. We welcome the opportunity to clarify any issues or respond to questions from potential applicants. Direct inquiries regarding programmatic issues to: Anthony Hayward, M.D., Ph.D. Director, 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) 435-0790 FAX: (301) 480-3661 Email: haywarda@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 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 Program Announcement (PA), Human Embryonic Stem Cell Research Resource Infrastructure Enhancement Award, is related to one or more of the 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 clinical research projects unless a clear and compelling justification is 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 clinical research should read the AMENDMENT "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice- files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at <http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm>. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; 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. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. 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. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. This policy announcement is found in the NIH Guide for Grants and Contracts Announcement dated June 5, 2000, at the following website: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. 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. 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. This amendment pertains to data that are (1) first produced in a project that is supported 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). Accessible under this amendment are research data, not trade secrets, commercial information, intellectual property, research resources, or other physical objects. For more information about this amendment, including the definition of data, please see http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.333 and 93.866. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) 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 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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