NOVEL APPROACHES TO ENHANCE STEM CELL RESEARCH Release Date: April 13, 1999 PA NUMBER: PA-99-086 P.T. National Center for Research Resources National Heart, Lung and Blood Institute National Institute of Child Health and Human Development National Institute of Diabetes and Digestive and Kidney Diseases National Institute of Mental Health Application Receipt Dates: June 1, 1999; October 1, 1999; February 1, 2000 SOME APPLICATIONS UNDER THIS PA USE THE MODULAR GRANT AND JUST-IN-TIME CONCEPTS. THE PA INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS PA. PURPOSE The purpose of this program announcement (PA) is to encourage the submission of applications for research to enhance stem cells as a model biological system. Research to isolate, characterize and identify totipotent and multipotent stem cells from nonhuman biomedical research animal models, as well as to generate reagents and techniques to characterize and separate those stem cells from other cell types is encouraged. Innovative approaches to the problems of making multipotent stem cells available from a variety of nonhuman sources, and to creating reagents that will identify those stem cells across species and allow for separation of multipotent stem cells from differentiated cell types, will be stressed. Accordingly, the Exploratory/Developmental Grants (R21) and Research Project (R01) grant mechanisms will be used. 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 PA, Novel Approaches to Enhance Stem Cell Research, is related to the priority areas of 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 "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by foreign and 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 Exploratory/Developmental Grants (R21) mechanism and the Research Project (R01) grant mechanism will be used to support projects under this Program Announcement (PA). Under these mechanisms, the applicant will plan, direct and carry out the research program. The proposed project period during which the research will be conducted should adequately reflect the time required to accomplish the stated goals and be consistent with the policy for grant support. However, because the purpose of R21 grants is to help applicants acquire preliminary data for use in preparing traditional Research Project grant (R01) or Resource-Related Research Project grant (R24) applications, support for the R21 grants is limited to two years with a maximum of $100,000 direct costs requested per year. For R01 grant applications, applicants planning to submit an investigator- initiated new (type 1), competing continuation (type 2), competing supplement, or any amended/revised version requesting $500,000 or more in direct costs for any year are advised that they must contact the Institute or Center (IC) program staff before submitting the application, i.e., as plans for the study are being developed. Furthermore, the applicant must obtain agreement from the IC staff that the IC will accept the application for consideration for award. Finally, the applicant must identify, in a cover letter sent with the application, the staff member and Institute or Center who agreed to accept assignment of the application. This policy requires an applicant to obtain agreement for acceptance of both any such application and any such subsequent amendment. Refer to the NIH Guide for Grants and Contracts, March 20, 1998 at http://www.nih.gov/grants/guide/notice-files/not98-030.html Either R21 applications or R01 applications requesting $250,000 or less in direct costs should conform to modular grant application procedures as outlined below and in the section of this announcement entitled Application Procedures. For applications requesting $250,000 or less in direct costs, specific application instructions have been modified to reflect "MODULAR GRANT" and "JUST- IN-TIME" streamlining efforts being examined by the NIH. The modular grant concept establishes specific modules in which direct costs may be requested as well as a maximum level for requested budgets. Only limited budgetary information is required under this approach. The just-in-time concept allows applicants to submit certain information only when there is a possibility for an award. It is anticipated that these changes will reduce the administrative burden for the applicants, reviewers and Institute staff. Complete and detailed instructions and information on Modular Grants can be found at http://www.nih.gov/grants/funding/modular/modular.htm. The following information in this section refers only to applications using the modular grant procedures. o Applications requesting $250,000 or less in direct costs, must request direct costs in $25,000 modules, up to a total direct cost request of $250,000 per year. A typical modular grant application will request the same number of modules in each year. o Application budgets will be simplified. Detailed categorical budget information will not be submitted with the application; budget form pages of the application kits will not be used. Instead, total direct costs requested for each year will be presented. Information, in narrative form, will be provided only for Personnel and, when applicable, for Consortium/Contractual Costs. See the section on application instructions below. o Additional narrative budget justification will be required in the application only if there is a variation in the number of modules requested. o There will be no routine escalation for future years. In determining the total for each budget year, applicants should first consider the direct cost of the entire project period. Well-justified modular increments or decrements in the total direct costs for any year of the project that reflect substantial changes in expected future activities may be requested. For example, purchase of major equipment in the first year may justify a higher overall budget in the first, but not in succeeding years. o Other Support pages of the PHS 398 will not be submitted with the application. o Information on research projects ongoing or completed during the last three years of the principal investigator and key personnel will be provided as part of the "Biographical Sketch." This information will include the specific aims, overall goals and responsibilities and should include Federal and non-Federal support. This information will be used by reviewers in the assessment of each individual's qualifications for a specific role in the proposed project. o Following peer review, information about Other Research Support will be requested by NIH from the applicant for applications being considered for award. o Additional budget information will be requested only under special circumstances. RESEARCH OBJECTIVES Summary Embryonic stem cells, and other stem cells are valuable biomedical research models for the study of biological and disease processes, and for creation of disease models. In addition, these cells hold tremendous promise as model systems for development of therapeutics and for development of replacement tissues through understanding of control of their differentiation. Thus far, embryonic stem cells have been isolated from several biomedically important nonhuman research models. In addition, stem cells with a more restricted potential have been characterized from post-embryonic tissue types. However, research is needed to provide for a full array of totipotent and multipotent stem cells from nonhuman biomedical research animal models, as well as to provide the research tools to identify, characterize, and purify those cells. This initiative will support the isolation and characterization of embryonic and other multipotent stem cells in a variety of nonhuman animal species. Examples of research areas appropriate to this announcement include, but are not limited to: o Projects to expand the number of nonhuman animal model systems in which embryonic stem cells are available o Projects to identify, isolate, culture and characterize multipotent stem cell populations derived from nonhuman embryonic stem cells o Projects to identify, isolate, culture and characterize multipotent stem cells from post-fetal tissue types o Projects to generate and use panels of markers for stem cell attributes common across species for use in characterization and isolation of stem cells in a range of animal species or tissues o Projects to create universal methods of culture to maintain the undifferentiated state of embryonic or other characterized, multipotential stem cells across nonhuman animal species. Projects supported by the National Center for Research Resources under this PA are intended to generate research tools, reagents or multipotential stem cells of utility to research on a broad range of tissue or cell types and of interest to more than one categorical or disease-oriented Institute or Center of the National Institutes of Health. Projects that will focus on research on tissues or disease processes specific to the mission of an Institute or Center should be directed to the respective Institute or Center. The research supported under this PA should clearly expand the usefulness of nonhuman animal model systems by generating multipotential stem cells appropriate to those systems and tools that will allow for further research on those stem cells. The results of R21 projects are expected to include preliminary data appropriate for applications for further support through the Research Project grant (R01) or Resource-Related Research Projects grant (R24) mechanism. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 4/98) and will be accepted at the standard application deadlines as indicated in the application kit. Application kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301-710-0267, email: grantsinfo@nih.gov. Forms are online at http://www.nih.gov/grants/funding/phs398/forms_toc.html. The title and number of the announcement must be typed in Section 2a on the face page of all applications. Applications requesting $250,000 or less in direct costs per year should conform to modular grant application procedures as announced in the NIH Guide, December 15, 1998. Instructions for the PHS 398 form should be followed except, for applications under modular grant procedures, the following special instructions apply: o FACE PAGE: Items 7a and 7b should be completed, indicating Direct Costs (in $25,000 increments up to a maximum of $250,000) and Total Costs [Modular Total Direct plus Facilities and Administrative (F&A) costs] for the initial budget period. Items 8a and 8b should be completed indicating the Direct and Total Costs for the entire proposed period of support. o DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form Page 4 of the PHS 398. It is not required and will not be accepted with the application. o BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete the categorical budget table on Form Page 5 of the PHS 398. It is not required and will not be accepted with the application. o NARRATIVE BUDGET JUSTIFICATION - Use a Modular Grant Budget Narrative page. (See http://www.nih.gov/grants/funding/modular/modular.htm for sample pages.) At the top of the page, enter the total direct costs requested for each year. o Under Personnel, List key project personnel, including their names, percent of effort, and roles on the project. No individual salary information should be provided. o For Consortium/Contractual costs, provide an estimate of total costs (direct plus facilities and administrative) for each year, each rounded to the nearest $1,000. List the individuals/organizations with whom consortium or contractual arrangements have been made, the percent effort of key personnel, and the role on the project. Indicate whether the collaborating institution is foreign or domestic. The total cost for a consortium/ contractual arrangement is included in the overall requested modular direct cost amount. o Provide an additional narrative budget justification for any variation in the number of modules requested. o BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by reviewers in the assessment of each individual's qualifications for a specific role in the proposed project, as well as to evaluate the overall qualifications of the research team. A biographical sketch is required for all key personnel, following the instructions below. No more than three pages may be used for each person. A sample biographical sketch may be viewed at: http://www.nih.gov/grants/funding/modular/modular.htm -Complete the educational block at the top of the form page; -List current position(s) and then previous positions; -List selected peer-reviewed publications, with full citations; -Provide information, including overall goals and responsibilities, on research projects ongoing or completed during the last three years. o CHECKLIST - This page should be completed and submitted with the application. If the F&A rate agreement has been established, indicate the type of agreement and the date. It is important to identify all exclusions that were used in the calculation of the F&A costs for the initial budget period and all future budget years. For all applications, the completed original application and five legible copies must be sent or delivered to: CENTER FOR SCIENTIFIC REVIEW (formerly Division of Research Grants) NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040-MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) REVIEW CONSIDERATIONS Applications will be assigned on the basis of established Public Health Service referral guidelines. Applications will be reviewed for scientific and technical merit by study sections of the Center for Scientific Review, NIH (or by the review group of the relevant Institute, Center, or Division), in accordance with the standard 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 appropriate national advisory council or board. 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: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge by advanced? What will be the effect of these studies on the concepts or methods that drive this field? o Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? o Innovation: Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? 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 (if any)? o Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? Innovation and potential significance of the proposed research are major considerations in the evaluation of applications for R21 grants. In addition to the above criteria, in accordance with NIH policy, all applications will be reviewed with respect to the following: o Appropriateness 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. AWARD CRITERIA Applications will compete for available funds with all other approved applications assigned to that Institute or Center. The following will be considered in making funding decisions: o Quality of the proposed project as determined by peer review o Availability of funds o Program priority. INQUIRIES Inquiries 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) 480-3659 Email: jillc@ncrr.nih.gov Carol H. Letendre, Ph.D. Division of Blood Diseases and Resources National Heart, Lung, and Blood Institute 6701 Rockledge Drive, MSC 7950 Bethesda, MD 20892-7950 Telephone: (301) 435-0080 FAX: (301) 480-0867 Email: letendrc@gwgate.nhlbi.nih.gov Richard J. Tasca, Ph.D. Center for Population Research National Institute of Child Health and Human Development 6100 Executive Boulevard, Room B01-MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-6515 FAX: (301) 496-0962 Email: rt34g@nih.gov David G. Badman, Ph.D. Division of Kidney, Urologic and Hematologic Diseases National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, Room 6AS-13C, MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-7717 FAX: (301) 480-3510 Email: David_Badman@nih.gov Hemin R. Chin, Ph.D. Division of Basic and Clinical Neuroscience Research National Institute of Mental Health 6001 Executive Boulevard, Room 7190, MSC 9643 Bethesda, MD 20892-9643 Telephone: (301) 443-1706 FAX: (301) 443-9890 Email: hemin@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 Telephone: (301) 435-0844 FAX: (301) 480-3777 Email: jh41m@nih.gov Ms. Jane R. Davis Division of Extramural Affairs National Heart, Lung, and Blood Institute 6701 Rockledge Drive, MSC 7926 Bethesda, MD 20892-7926 Telephone: (301) 435-0166 FAX: (301) 480-3310 Email: jane_davis@nih.gov Ms. Melinda Nelson Grants Management Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8B17-MSC7510 Bethesda, MD 20892-7510 Telephone: (301) 496-5481 FAX: (301) 402-0915 Email: mn23z@nih.gov Ms. Aretina Perry Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, Room 6AN-38B, MSC 6600 Bethesda, MD 20892 Telephone: (301) 594-8862 FAX: (301) 480-3504 Email: perrya@extra.niddk.nih.gov Ms. Diana S. Trunnell Grants Management Branch National Institute of Mental Health 6001 Executive Boulevard, Room 6115, MSC 9605 Bethesda, MD 20892-9605 Telephone: (301) 443-2805 FAX: (301) 443-6885 Email: dtrunell@mail.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Nos. 93.849, 93.839, 93.864, 93.848, 93.242. 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 or 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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