HIGH IMPACT RESEARCH: FEASIBILITY STUDIES Release Date: March 6, 2000 PA NUMBER: PAR-00-075 National Institute on Deafness and Other Communication Disorders Application Receipt Date: July 21, 2000 THIS PA USES THE "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. IT INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS PA. PURPOSE The National Institute on Deafness and Other Communication Disorders (NIDCD) invites applications for feasibility studies of high impact (HI) research focused on hearing, balance, smell, taste, voice, speech, and language, the scientific mission areas of the NIDCD. This Program Announcement (PA) supersedes a previous NIDCD PA: High Impact Research: Feasibility Studies, PAR-99-092 (NIH Guide, April 29, 1999). HI research involves pilot/feasibility studies in which the technological, methodological, or theoretical approach to a problem lacks a historical precedent or sufficient preliminary/baseline data, but whose successful outcome would have a major impact on a scientific area or field. HI research has been described as "groundbreaking" and "paradigm shifting" (High Risk/Innovative Research Identification in NIH Peer Review Notes, Division of Research Grants, June 1993). 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 focus areas. This PA is related to one or more of the focus areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of state or local governments, and eligible agencies of the Federal government. Applications from minority individuals, women, and individuals with disabilities are encouraged. Foreign organizations or organizations in foreign countries are not eligible; subcontracts to foreign organizations are allowable, with sufficient justification. Submission of an application under this PA precludes concurrent submission of any other application containing substantially the same research proposal. In addition, these R21 awards 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. MECHANISM OF SUPPORT Support for this program will be provided through the National Institutes of Health (NIH) Exploratory/Developmental Grants (R21) mechanism. This mechanism offers support for HI research that lacks a historical precedent or sufficient preliminary data. Areas of science in which there is a sufficient historical basis or sufficient preliminary data to support the submission of a regular research project grant application do not qualify under this Program Announcement. However, the applicant does have the responsibility for developing a demonstrably sound research plan designed to assess the feasibility of the proposed pilot project. It is expected that the preliminary data generated by these grants, if promising, will serve as a basis for a more extensive follow-up investigation, typically pursued through the submission of an R01 grant application. This initiative provides nonrenewable awards for up to two years of support and up to $50,000 in direct costs per year. However, an application whose direct cost budget includes Facilities and Administration (F&A) costs associated with subcontract/consortium activity may exceed the $50,000 ceiling by the amount of one module ($25,000). The grants may be extended in time, but not amount, at the discretion of the applicant organization. Investigators are encouraged to consider carefully whether their research can best be accomplished through this or other grant mechanisms, such as the R01 or the small grant (R03) program of the NIDCD. The R03 program is for scientists who are in the early stages of pursuing an independent research career, but are not yet ready to submit a new-investigator R01 application. Specific application instructions have been modified to reflect "MODULAR GRANT" 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. 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://grants.nih.gov/grants/funding/modular/modular.htm. RESEARCH OBJECTIVES The purpose of this PA is to encourage the submission of feasibility studies for HI research that have the potential for leading to a technological, methodological, or conceptual breakthrough or major contribution in the basic and clinical biomedical and behavioral sciences of human communication. This research may involve: 1) pilot testing of novel scientific experimental hypotheses, 2) the development of new or novel techniques or technologies, and/or 3) the acquisition of a body of data that is potentially high-impact for the scientific enterprise. The research must be focused on one or more areas within the scientific mission of the NIDCD: hearing, balance, smell, taste, voice, speech, and language. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18, 1994. 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 may obtain copies from these sources or from the program staff person listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES The PHS 398 (rev 4/98) is the form to be used to apply for this program. The form may be downloaded from the NIH Home Page at http://grants.nih.gov/grants/forms.htm. It is also available at most institutional offices of sponsored research, or it may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892-7910, telephone: 301/435-0714, email: GrantsInfo@nih.gov. The instructions in the PHS 398 application kit must be adhered to, except where they have been modified by the following Supplemental Instructions. RESEARCH PLAN: Do not exceed a total of 10 pages for the research plan, Sections a-d. This limitation includes the introductory paragraph described below, tables and figures, but not Sections e-i. Do not use the appendix to circumvent the 10- page limit by including tables or figures in the appendix that should appear in the research plan. Amply justify the designation of the application as a feasibility study for HI research in an introductory paragraph at the beginning of the research plan. Justify why the project would not be appropriate for submission as a traditional research grant and how this project, if fruitful, would enable the applicant to craft a research program appropriate for submission as a full-scale research grant application. Label this paragraph, Justification as High Impact Research. Applications that lack the introductory justification or exceed the page limitation will not be reviewed and will be returned to the applicant. Some applications submitted in response to this PA may be design-driven (e.g., development of novel or new technologies) or data-driven rather than problem-driven (e.g., testing of scientific hypotheses). In the first two cases, the Specific Aims should state the technique/technology development needs or the data acquisition needs driving the research rather than the experimental hypotheses to be tested. BUDGET INSTRUCTIONS The total direct costs must be requested in accordance with the program guidelines and the modifications made to the standard PHS 398 application instructions described below: PHS 398 o FACE PAGE: Items 7a and 7b should be completed, indicating Direct Costs (in $25,000 increments up to a maximum of $50,000 or $75,000, the latter in the case of consortia for contractual activity) 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://grants.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 direct cost amount for the application. Under these circumstances, the latter may exceed $50,000 by one module ($25,000). Provide an additional narrative budget justification for any variation in the number of modules or direct cost amount requested across a two-year grant period. 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://grants.nih.gov/grants/funding/modular/modular.htm - Complete the educational block at the top of the form page; - List position(s) and any honors; - Provide information, including overall goals and responsibilities, on research projects ongoing or completed during the last three years. - List selected peer-reviewed publications, with full citations; and 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. o The applicant should provide the name and phone number of the individual to contact concerning fiscal and administrative issues, if additional information is necessary following the initial review. Submission Instructions The title and number of this PA must be typed on line 2 of the face page of the application form and the YES box must be marked. The completed original application and three copies (less appendices) must be submitted 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) Send two additional copies of the application and five sets of appendices 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 The application receipt date is July 21, 2000; applications received after this date will be returned to the applicant. The earliest date of award is May 1, 2001. This PA may be reissued in the future. REVIEW CONSIDERATIONS All applications will be examined for completeness by the Center for Scientific Review and responsiveness to this PA by NIDCD staff. Complete and responsive applications will then be reviewed for scientific and technical merit in accordance with the standard NIH procedures by a review group convened by the NIDCD. As part of the initial review, all applications will receive a written critique. Those applications deemed to have the highest merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level of review by the NIDCD 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 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. 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. (1) Significance: Does this feasibility study have the potential to significantly impact the scientific enterprise, and if so, to what degree? If the aims of the application are achieved, how will scientific knowledge be advanced? Will a successful outcome from this feasibility study lead directly to more extensive follow-up studies that would likely achieve the long-term goals of this application? (2) 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? Does the application contain a demonstrably sound plan designed to assess the feasibility of the pilot project? (3) Innovation: Does the project employ novel concepts, approaches or method? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? Does the project generate a body of data that provides a foundation for important new research directions? (4) 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)? (5) Environment: Does the scientific environment in which the work will be conducted contribute to the probability of success? Is there evidence of institutional support for the research? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: o The adequacy of plans to include children, both genders, and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. o The reasonableness of the proposed budget and the project’s duration in relation to the proposed research. o The adequacy of the measures proposed for protection of humans, animals and/or the environment, to the extent they may be adversely affected by the research proposed in the application. AWARD CRITERIA Applications will compete for available funds with all other favorably recommended applications. Funding decisions will be based on the quality of the proposed project as determined by peer review, program priorities, and availability of funds. INQUIRIES NIDCD staff welcome the opportunity to clarify any issues or questions about this initiative from potential applicants. Direct inquiries regarding programmatic issues, including eligibility and responsiveness, to: Hearing: Dr. Amy Donahue Telephone: (301) 402-3458 Email: amy_donahue@nih.gov Dr. Nancy Freeman Telephone: (301) 402-3458 Email: nancy_freeman@nih.gov Dr. Thomas Johnson Telephone: (301) 402-3461 Email: thomas_johnson@nih.gov Dr. Lynn Luethke Telephone: (301) 402-3461 Email: lynn_luethke@nih.gov Balance: Dr. Daniel Sklare Telephone: (301) 496-1804 Email: daniel_sklare@nih.gov Smell: Dr. Rochelle Small Telephone: (301) 402-3464 Email: rochelle_small@nih.gov Taste: Dr. Barry Davis Telephone: (301) 402-3464 Email: barry_davis@nih.gov Voice/Speech: Dr. Beth Ansel Telephone: (301) 402-3461 Email: beth_ansel@nih.gov Language: Dr. Judith Cooper Telephone: (301) 496-5061 Email: judith_cooper@nih.gov The address and FAX number for all of the above named persons are: Division of Extramural Research National Institute on Deafness and Other Communication Disorders 6120 Executive Boulevard, Room 400-C, MSC-7180 Bethesda, MD 20892-7180 FAX: (301) 402-6251 Direct inquiries regarding fiscal matters to: Castilla McNamara, M.S. Grants Management Branch Division of Extramural Research 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: CM249E@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.173. 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. 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 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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