NOVEL APPROACHES TO ENHANCE ANIMAL STEM CELL RESEARCH RELEASE DATE: August 9, 2002 PA NUMBER: PA-02-147 (superseded by PA-04-125) EXPIRATION DATE: May 31, 2004 unless reissued. National Center for Research Resources (NCRR) (http://www.ncrr.nih.gov/) National Cancer Institute (NCI) (http://www.nci.nih.gov/) National Eye Institute (NEI) (http://www.nei.nih.gov/) National Heart, Lung and Blood Institute (NHLBI) (http://www.nhlbi.nih.gov/) National Institute of Biomedical Imaging and Bioengineering (NIBIB) (http://www.nibib.nih.gov/) National Institute of Child Health and Human Development (NICHD) (http://www.nichd.nih.gov/) National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (http://www.niddk.nih.gov/) National Institute of Mental Health (NIMH) (http://www.nimh.nih.gov/) National Institute of Neurological Disorders and Stroke (NINDS) (http://www.ninds.nih.gov/) National Institute on Aging (NIA) (http://www.nia.nih.gov/) National Institute on Deafness and Other Communication Disorders (NIDCD) (http://www.nidcd.nih.gov/) National Institute on Drug Abuse (NIDA) (http://www.nida.nih.gov/) THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Research Objectives o Mechanism(s) of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Where to Send Inquiries o Submitting an Application o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE OF THIS PA The purpose of this program announcement (PA) is to encourage the submission of applications for research to enhance animal stem cells as model biological systems. 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. Studies involving human subjects are not allowed under this PA. This PA supersedes PA-01-076 issued earlier by the NCRR. RESEARCH OBJECTIVES 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 promise as model systems for development of therapeutics and for development of replacement tissues through understanding of control of cellular differentiation. Thus far, embryonic stem cells have been isolated from some 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) mechanisms. Not all of the NIH Institutes and Centers support R24 applications. Applicants should contact the relevant Program Official before submitting an R24 application. For further information about the NCRR R24 program please see (http://www.ncrr.nih.gov/compmed/cmguidfl.pdf) or (http://www.ncrr.nih.gov/compmed/cm_rpg.asp). MECHANISMS OF SUPPORT This PA will use the NIH research project (R01) and exploratory/developmental grant (R21) award mechanisms. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. This PA uses just-in-time concepts. It also uses the modular as well as the non-modular budgeting formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular format. Otherwise follow the instructions for non- modular research grant applications. Support for R21 grants is limited to two years with a maximum of $100,000 direct costs requested per year. ELIGIBLE INSTITUTIONS You may submit (an) application(s) if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Domestic or foreign INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. WHERE TO SEND INQUIRIES We encourage your inquiries concerning this PA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into two areas: scientific/research, and financial or grants management issues: o Direct your questions about scientific/research issues to: John D. Harding, Ph.D. Division of Comparative Medicine National Center for Research Resources 6705 Rockledge Drive, Suite 6050, MSC 7965 Bethesda, MD 20892-7965 Telephone: (301) 435-0744 FAX: (301) 480-3819 Email: hardingj@ncrr.nih.gov Colette Freeman, Ph.D. Cancer Cell Biology Branch Division of Cancer Biology National Cancer Institute 6130 Executive Boulevard, Room 5030 Bethesda, MD 20892-7396 Telephone: (301) 496-7028 FAX: (301) 402-1037 Email: cf33a@nih.gov Richard S. Fisher, Ph.D. Division of Extramural Research National Eye Institute 6120 Executive Boulevard, Suite 350, MSC 7164 Bethesda, MD 20892-7164 Telephone: (301) 451-2020 FAX: (301) 402-0528 Email: cornea@nih.gov John W. Thomas, Ph.D. Division of Blood Diseases and Resources National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Room 10154 Bethesda, MD 20892-7950 Telephone: (301) 435-0050 FAX: (301) 451-5453 Email: thomasj@nhlbi.nih.gov Christine A. Kelley, Ph.D. Division of Bioengineering National Institute of Biomedical Imaging and Bioengineering 6707 Democracy Boulevard, Room 957 Bethesda Md 20814-9692 Telephone: (301) 451-4778 FAX: (301) 480-4974 Email: kelleyc@mail.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) 435-6973 FAX: (301) 496-0962 Email: rt34g@nih.gov David G. Badman, Ph.D. Hematology Program National Institute of Diabetes and Digestive and Kidney Diseases 2 Democracy Plaza, Room 621, MSC 5458 6707 Democracy Blvd. Bethesda, MD 20892-5458 Telephone: (301) 594-7717 FAX: (301) 480-3510 Email: db70f@nih.gov Beth-Anne Sieber, Ph.D. Developmental Neurobiology Program National Institute of Mental Health 6001 Executive Boulevard, Room 7186, MSC 9641 Bethesda, MD 20892-9641 Telephone: (301) 443-5288 FAX: (301) 402-4720 Email: sieberb@helix.nih.gov Arlene Y. Chiu, Ph.D. Repair and Plasticity Program National Institute of Neurological Disorders and Stroke Neuroscience Center, Room 2206 6001 Executive Boulevard Bethesda, MD 20892 Telephone: (301) 496-1447 FAX: (301) 480-1080 Email: chiua@ninds.nih.gov Jill L. Carrington, Ph.D. Biology of Aging Program National Institute on Aging 7201 Wisconsin Avenue, Suite 2C231 Bethesda, MD 20892-9205 Telephone: (301) 496-6402 FAX: (301) 402-0010 Email: carringtonj@nia.nih.gov Nancy L. Freeman, Ph.D. Hearing and Balance/Vestibular Branch National Institute on Deafness and Other Communication Disorders Executive Plaza South-400C 6120 Executive Boulevard, MSC 7180 Rockville, MD 20852 Telephone: (301) 402-3458 FAX: (301) 402-6251 Email: Nancy_Freeman@nih.gov Jonathan D. Pollock, Ph.D. Genetics and Molecular Neurobiology Research Branch National Institute on Drug Abuse 6001 Executive Boulevard, Room 4274 Bethesda, MD 20892 Telephone: (301) 435-1309 FAX: (301) 594-6043 Email: jp183r@nih.gov o Direct your questions about financial or grants management matters to: Ms. Irene Grissom 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: grissomi@ncrr.nih.gov Ms. Crystal Wolfrey Grants Administration Branch National Cancer Institute 6120 Executive Boulevard, Room 243 Bethesda, MD 20892 Telephone: (301) 496-8634 FAX: (301) 496-8601 Email: WolfreyC@gab.nci.nih.gov Mr. William W. Darby Division of Extramural Research National Eye Institute 6120 Executive Boulevard, Suite 350, MSC 7164 Bethesda, MD 20892-7164 Telephone: (301) 451-2020 FAX: (301) 496-9997 Email: wwd@nei.nih.gov Mr. Robert Vinson 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: vinsonr@nhlbi.nih.gov Ms. Nancy Curling Grants Management Office National Institute of Biomedical Imaging and Bioengineering 6707 Democracy Blvd, Room 975 Bethesda, MD 20814-9692 Telephone: (301) 451-4782 FAX: (301) 480-4974 Email: curlingn@mail.nih.gov Ms. Kathy Hancock Grants Management Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8A17M Bethesda, MD 20892-7510 Telephone: (301) 496-5482 FAX: (301) 402-0915 Email: kathy.hancock@nih.gov Ms. Aretina Perry-Jones Grants Management Branch National Institute of Diabetes and Digestive and Kidney Diseases 2 Democracy Plaza, Room 632, MSC 5456 6707 Democracy Blvd. Bethesda, MD 20892-5456 Telephone: (301) 594-8862 FAX: (301) 480-3504 Email: perrya@extra.niddk.nih.gov Ms. Carol Robinson Grants Management Branch National Institute of Mental Health 6001 Executive Boulevard, Room 6118, MSC 9605 Bethesda, MD 20892-9605 Telephone: (301) 443-3858 FAX: (301) 443-6885 Email: cr2092@nih.gov Mr. Jeffrey Domanski Grants Management Branch, DER National Institute of Neurological Disorders and Stroke Neuroscience Center, Room 3290, MSC 9537 6001 Executive Boulevard Bethesda, MD 20892 Telephone: (301) 496-9231 FAX: (301) 402-0219 Email: jd356w@nih.gov Ms. Linda Whipp Grants and Contracts Management Office National Institute on Aging 7201 Wisconsin Avenue, Suite 2N212 Bethesda, MD 20892-9205 Telephone: (301) 496-1472 FAX: (301) 402-3672 Email: whippl@nih.gov Ms. Sara Stone Grants Management Office National Institute on Deafness and Other Communication Disorders 6120 Executive Boulevard, Room 400-B, MSC 7180 Bethesda, MD 20892-7180 Telephone: (301) 402-0909 FAX: (301) 402-1758 Email: stones@nidcd.nih.gov Gary Fleming, J.D., M.A. Grants Management Branch Office of Planning and Resource Management National Institute on Drug Abuse 6001 Executive Boulevard, Room 3131, MSC 9541 Bethesda, MD 20892-9541 Telephone: (301) 443-6710 FAX: (301) 594-6847 Email: gf6s@nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov. APPLICATION RECEIPT DATES: Applications submitted in response to this program announcement will be accepted at the standard application deadlines, which are available at http://grants.nih.gov/grants/dates.htm. Application deadlines are also indicated in the PHS 398 application kit. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications requesting up to $250,000 per year in direct costs must be submitted in a modular grant format. The modular grant format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular grants. Additional information on modular grants is available at http://grants.nih.gov/grants/funding/modular/modular.htm. SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR: Applications requesting $500,000 or more in direct costs for any year must include a cover letter identifying the NIH staff member within one of NIH institutes or centers who has agreed to accept assignment of the application. Applicants requesting more than $500,000 must carry out the following steps: 1) Contact the IC program staff at least 6 weeks before submitting the application, i.e., as you are developing plans for the study; 2) Obtain agreement from the IC staff that the IC will accept your application for consideration for award; and, 3) Identify, in a cover letter sent with the application, the staff member and IC who agreed to accept assignment of the application. This policy applies to all investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended or revised version of these grant application types. Additional information on this policy is available in the NIH Guide for Grants and Contracts, October 19, 2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the checklist, and five signed photocopies in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) APPLICATION PROCESSING: Applications must be received by or mailed on or before the receipt dates described at http://grants.nih.gov/grants/funding/submissionschedule.htm. The 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 a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique. PEER REVIEW PROCESS Applications submitted for this PA will be assigned on the basis of established PHS referral guidelines. An appropriate scientific review group convened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit. As part of the initial merit review, all applications will: o Receive a written critique o Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score o 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 your application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals: o Significance o Approach o Innovation o Investigator o Environment The scientific review group will address and consider each of these criteria in assigning your application's overall score, weighting them as appropriate for each application. Your 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, you may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. (1) SIGNIFICANCE: Does your study address an important problem? If the aims of your application are achieved, how do they advance scientific knowledge? What will be the effect of these studies on the concepts or methods that drive this field? (2) APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Do you acknowledge potential problem areas and consider alternative tactics? (3) INNOVATION: Does your project employ novel concepts, approaches or methods? Are the aims original and innovative? Does your project challenge existing paradigms or develop new methodologies or technologies? (4) INVESTIGATOR: Are you appropriately trained and well suited to carry out this work? Is the work proposed appropriate to your experience level as the principal investigator and to that of other researchers (if any)? (5) ENVIRONMENT: Does the scientific environment in which your 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? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: PROTECTIONS: 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. BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. AWARD CRITERIA Applications submitted in response to a PA will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: o Scientific merit of the proposed project as determined by peer review o Availability of funds o Relevance to program priorities REQUIRED FEDERAL CITATIONS 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. Data that are (1) first produced in a project that is supported in whole or in part 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) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. 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. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. 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 PA 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. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance Nos. 93.306, 93.396, 93.867, 93.839, 93.287, 93.864, 93.849, 93.242, 93.853, 93.866, 93.173, 93.279 and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. 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 described at http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the 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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