STEM CELL POTENTIAL OF THE MAMMALIAN OLFACTORY EPITHELIUM RELEASE DATE: November 18, 2002 (see NOT-DC-03-003) RFA: DC-03-002 LETTER OF INTENT RECEIPT DATE: February 3, 2003 APPLICATION RECEIPT DATE: March 11, 2003 National Institute on Deafness and Other Communication Disorders (NIDCD) (http://www.nidcd.nih.gov) THIS REQUEST FOR APPLICATIONS (RFA) CONTAINS THE FOLLOWING INFORMATION o Purpose of the RFA o Research Objectives o Mechanism of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Letter of Intent o Submitting an Application o Sending an Application to the NIH o Research Plan o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citation PURPOSE The National Institute on Deafness and Other Communication Disorders (NIDCD) supports clinical and basic biomedical research in the area of human olfaction (smell). The partial or complete loss of smell (anosmia) affects approximately 2.5 million people and poses serious health risks as the presence of rancid food, toxic odors and smoke often go undetected. The loss of smell adversely affects the perceived flavor of foods, which impacts on diet and nutrition, especially in the elderly. The clinical treatment of anosmia will require a better understanding of the mechanisms that regulate differentiation, proliferation and the injury response of precursor, multipotent stem cells in the olfactory epithelium . The NIDCD invites applications for exploratory pilot studies focused on stem cell biology, using the precursor, multipotent stem cells of the mammalian olfactory epithelium as a model system. The proposed research should involve the testing of novel hypotheses or the development of new techniques or methodologies that will mainly benefit future stem cell research in the olfactory system, but has the potential to increase our understanding of stem cell biology elsewhere in the brain. The proposed areas of investigation should lack the pilot data needed for the submission of a regular research grant; however, the soundness and feasibility of the research plan must be demonstrated. It is intended that, if promising, the pilot data generated by these exploratory grants may serve as a basis for a more extensive follow-up investigation (e.g., an investigator-initiated R01 grant application). The NIDCD encourages applications from investigators who are conducting research outside the field of olfaction and possess expertise in stem cell biological research, and who are using methodological approaches that have not been typically applied to but which would greatly promote scientific progress within the field of olfaction. RESEARCH OBJECTIVES Olfactory receptor neurons are exposed to the external environment and are susceptible to toxic airborne chemicals, infectious pathogens and physical damage following frontal head trauma. Olfactory receptor neurons are ordinarily replaced periodically throughout life and also have the capacity to proliferate in response to acute injury. Such replacement and proliferation are possible due to the presence of precursor, multipotent stem cells in the olfactory epithelium. These precursor cells possess the ability to differentiate into either mature olfactory receptor neurons or non- neuronal support cells. An understanding of the injury response of the olfactory epithelium will require the study of the mechanisms that regulate the differentiation and proliferation of these precursor cells. Furthermore, the olfactory epithelium represents a readily accessible source of an abundant sample of multipotent stem cells for studies focused on stem cell biological research or technology development. The regenerative capacity of the olfactory epithelium, its reconstitution after injury and the reinnervation of the olfactory bulb have been studied extensively. Less is known about the genetic and molecular events and local environmental trophic influences that control and up-regulate precursor cell activity. The olfactory system affords the opportunity to investigate the facile nature of one part of the nervous system in the hope to better understand and to improve the regenerative capabilities of other regions. This RFA is soliciting applications focused on the genetic, molecular and cellular mechanisms that regulate the lineage, differentiation and proliferation of the multipotent stem cells in the olfactory epithelium. Research efforts applying the contemporary tools of stem cell biology are of high importance. Areas of special interest include, but are not limited to: o The genetic and molecular control of the lineage pathway of olfactory precursor cells o The use of gene targeting or tissue-specific reporters to identify the various stages of neuronal differentiation o The identification of signaling pathways, growth factors and trophic cues that enhance functional integration within olfactory or other neural tissue o The development of tissue culture, harvesting, and cell sorting technologies to ensure an ample supply of purified precursor cells o The utility of using embryonic, hemopoietic and mesenchymal stem cells in a compromised olfactory system MECHANISM OF SUPPORT This RFA will use the NIH Exploratory/Developmental Grants (R21) mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. Future unsolicited, competing-continuation applications based on this project will compete with all investigator–initiated applications and will be reviewed according to the customary peer review procedures. An individual may submit only one application in response to this RFA as the principal investigator. The anticipated award date is December 1, 2004. This RFA uses just-in-time concepts, including the approved use of laboratory animals (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-064.html). It also uses the modular budgeting format. (see http://grants.nih.gov/grants/funding/modular/modular.htm). FUNDS AVAILABLE The NIDCD intends to commit approximately $1,000,000 in FY04 to fund 6 to 7 new grants in response to this RFA. An applicant may request a project period of up to 2 years and a budget for direct costs of up to $100,000 per year. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the NIDCD provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. At this time, it is not known if this RFA will be reissued. ELIGIBLE INSTITUTIONS You may submit an application if your institution has any of the following characteristics: o For-profit and non-profit organizations o Public and private, such as universities, colleges, hospitals, and laboratories o Units of state or local governments o Eligible agencies of the Federal government. o Domestic Foreign organizations or organizations in foreign countries are not eligible; subcontracts to foreign organizations are allowable, with sufficient justification. 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. SPECIAL REQUIREMENTS The amount of pilot data that typically accompanies an R01 application is not required as a part of this initiative. Nonetheless, the applicant has the responsibility to provide sufficient pilot data to demonstrate the soundness and feasibility of the research plan. Furthermore, the appropriate expertise of key personnel and collaborators to pursue such novel research must be evident. Individuals working outside the area of olfaction with expertise in stem cell research are encouraged to apply. This announcement highly encourages collaboration between stem cell biologists and the olfactory research community. Submission of an application under this RFA precludes submission of any other application to the NIH containing substantially the same research proposal. In addition, awards made in response to this initiative may not be used to supplement research projects currently supported by Federal or non-Federal funds, or to provide interim support of projects under review by the Department of Health and Human Services. Applications in response to this RFA with the intent to use human embryonic stem cells (hESC) must comply with federal guidelines. A cover letter signed by the principal investigator, appropriate institutional official and business office, acknowledging review and approval of the grant application proposing human embryonic stem cell research must be included. Within the Description on page 2 all applications must indicate the official identifier(s) for the appropriate hESC line(s) as found in the NIH Registry (http://escr.nih.gov/). In addition, compliance to all of the federal guidelines must be satisfied. These NIH guidelines are listed at, http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-049.html. Applications not including this information will be returned without further consideration. Answers to frequently asked questions about hESC may be found at: http://grants.nih.gov/grants/stem_cell_faqs.htm WHERE TO SEND INQUIRIES We encourage your inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues: o Direct your questions about scientific/research issues to: Dr. Barry Davis Director Taste and Smell Program National Institute on Deafness and Other Communication Disorders 6120 Executive Boulevard, Room 400-C, MSC-7180 Rockville, MD 20892-7180 Telephone: (301) 402-3464 FAX: (301) 402-6251 Email: barry_davis@nih.gov o Direct your questions about peer review issues to: Dr. Craig Jordan Chief, Scientific Review Branch National Institute on Deafness and Other Communication Disorders 6120 Executive Boulevard, Room 400-C, MSC-7180 Rockville, MD 20892-7180 Telephone: 301-496-8683 FAX: (301) 402-6250 Email: jordanc@nih.gov o Direct your questions about financial or grants management matters to: Sara Stone Chief, Grants Management Branch National Institute on Deafness and Other Communication Disorders 6120 Executive Boulevard, Room 400-B, MSC 7180 Rockville, MD 20892-7180 Telephone: (301) 402-0909 FAX: (301) 402-1758 Email: stones@nih.gov LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o 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 institute staff to estimate the potential review workload and to plan the review. The letter of intent is to be sent by February 3, 2003. The letter of intent should be sent to: Dr. Barry Davis Director Taste and Smell Program National Institute on Deafness and Other Communication Disorders 6120 Executive Boulevard, Room 400-C, MSC-7180 Rockville, MD 20892-7180 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. SENDING AN APPLICATION TO THE NIH 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, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) The title, STEM CELL POTENTIAL OF THE MAMMALIAN OLFACTORY EPITHELIUM, and the number of this announcement, RFA-02-005, must be typed on line 2 of the face page of the application form and the YES box must be marked. Send two additional copies of the application and five sets of appendices (if applicable) to: Chief, Scientific Review Branch Division of Extramural Research National Institute on Deafness and Other Communication Disorders 6120 Executive Boulevard, Room 400-C, MSC 7180 BETHESDA, MD 20892-7180 ROCKVILLE, MD 20852 (for express/courier service) RECEIPT AND REVIEW SCHEDULE Application Receipt Date: March 11, 2003 NIDCD Committee Review: June/July, 2003 Council Review: September, 2003 Earliest Funding: December, 2003 APPLICATION PROCESSING: Applications must be received by or mailed before the receipt date listed on the face page of the RFA. The Center for Scientific 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 a substantial revision of an application already reviewed, but such an application must include an Introduction addressing the previous critique. RESEARCH PLAN The applications submitted in response to this RFA must test specific hypotheses or develop new technologies or methodologies. Data-driven (e.g., database management, mining, or distribution) applications are not eligible. The current RFA provides nonrenewable awards for up to two years of support and up to $100,000 per year in direct costs. The total cost (Direct plus Facilities and Administrative costs (F & A costs) for any consortium/contractual arrangement must be included within the overall requested direct cost amount for the application, which can not exceed $100,000. PEER REVIEW PROCESS All applications will be examined for completeness by the CSR and for responsiveness by NIDCD staff. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Applications failing to comply with NIH grant format guidelines (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-037.html) will be returned. Complete and responsive applications will be reviewed for scientific and technical merit in accordance with standard NIH procedures by a review group convened by the NIDCD Scientific Review Branch. 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 National Deafness and Other Communication Disorders Advisory Council. 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. (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. INCLUSION: The adequacy of plans to include subjects from each gender, all racial and ethnic groups (and subgroups), and children, as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria included in the section on Federal Citations, below) BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. OTHER REVIEW CRITERIA: o Does the proposed research represent a test of novel ideas, techniques or methods that will impact the concepts that drive the field of olfactory stem cell research? o Will the successful outcome of the proposed studies likely generate sufficient data to pursue follow-up studies and lead to a full-scale research grant application? AWARD CRITERIA Applications submitted in response to a RFA 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 INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: 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: The NIH maintains a policy 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 is available at http://grants.nih.gov/grants/funding/children/children.htm. 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. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at http://grants.nih.gov/grants/stem_cells.htm and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov). It is the responsibility of the applicant to provide the official NIH identifier(s)for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review. 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 No. 93.173 and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. 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. 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. http://grants.nih.gov/grants/guide/pa-files/PA-02-015.html.


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