NIDCD SMALL GRANT PROGRAM Release Date: August 9, 2001 PA NUMBER: PA-01-126 (Superseded by PAR-04-062) National Institute on Deafness and Other Communication Disorders Application Receipt Dates: 2001 April 20, Aug. 24, Dec. 17 2002 April 22, Aug. 20, Dec. 17 2003 April 22, Aug. 20, Dec. 17 2004 April 22, Aug. 20, Dec. 17 THIS RFA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. USE THE MODULAR BUDGET INSTRUCTIONS THAT BEGIN ON PAGE 13 IN THE PHS 398 (REVISION 5/2001) AVAILABLE AT http://grants.nih.gov/grants/funding/phs398/phs398.html. THE INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS MUST BE USED WHEN RESPONDING TO THIS RFA/PA. PURPOSE This Program Announcement (PA) supersedes all previous announcements of the National Institute on Deafness and Other Communication Disorders (NIDCD) Small Grant (R03) Program for support of pilot research that is likely to lead to a subsequent individual research project grant (R01) application. The research must be focused on one or more of the areas within the biomedical and behavioral scientific mission of the NIDCD: hearing, balance, smell, taste, voice, speech, or language. The Small Grant Program is designed to support basic and clinical research of scientists who are in the early stages of establishing an independent research career. The R03 may be used to support individuals transitioning from postdoctoral status to their first independent research position. In addition, the R03 may be used by early-stage clinician-scientists planning to make future application for an NIDCD mentored research career development award (K-award) to demonstrate the feasibility of the research to be proposed in their K-award application. 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, NIDCD Small Grant Program, is related to several priority areas applicable to human communication. 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 and local governments, and eligible agencies of the Federal Government on behalf of eligible investigators. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply. Foreign institutions and United States organizations located in foreign countries are not eligible to apply for this program. The R03 Program supports the research of scientists who are in the early stages of establishing an independent research career in the basic and clinical sciences of human communication, including individuals transitioning from postdoctoral status to their first independent research position. Applicants are not required to have their own independent research space or equipment. It is intended that an R03 grant will enable such individuals to obtain preliminary data that is likely to lead to a subsequent individual research project grant (R01) application. The NIDCD encourages early-stage clinician-scientists planning to make future application for an NIDCD mentored research career development award (K- award), such as the Mentored Clinical Scientist Development Awards (K08) or Mentored Patient-Oriented Research Career Development Awards (K23), to consider applying for one year of support through an NIDCD R03 award, if needed to demonstrate the feasibility of the research to be proposed in their K08 or K23 application. In addition, recipients of NIDCD K08 and K23 awards may hold an R03 award concurrent with the K-award, providing the aggregate number of years of R03 support (prior to and during the K-award) does not exceed three years and that the R03 does not provide the K-awardee with additional salary support. The purpose of such an R03 award is to provide the mentored K-awardee with additional needed resources for the transition to independence. The research specific aims (SAs) of the R03 application should expand upon the SAs of the K08 or K23 award, rather than duplicate the SAs of the K-award. In this case, the concurrent professional effort associated with these awards is considered overlapping rather than additive. Former recipients of Federally-funded National Research Service Award (NRSA) fellowships and traineeships or mentored career development awards are eligible for this Small Grant Program. Individuals who have served as Principal Investigators on any NIH research grant (including subprojects of program project and center grants) or other Federally-funded research grants are not eligible for the NIDCD R03 mechanism. Other questions about eligibility may be directed to one of the program officials listed under INQUIRIES. MECHANISM OF SUPPORT Applications for the Small Grant Program use the R03 funding mechanism and the NIH Modular Grant format (see NIH Guide, Notice of Modular Grant Application and Award, December 15, 1998) in preparing the budget. Small grants may be submitted for up to 2 modules of $25,000 each ($50,000 Direct Costs per year), for up to three years of support. Complete and detailed instructions and information on Modular Grants can be found below under SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS and at http://grants.nih.gov/grants/funding/modular/modular.htm Modular Grant Application Forms can be found at ftp://ftp.grants.nih.gov/forms/398_forms.pdf. 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 protocols involving human subjects, unless a clear and compelling rationale and justification is 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 10.1-43). 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 in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994, available on the web at: http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm Specifically, the investigator must include a section titled Inclusion of Women and Minorities that describes the composition of the proposed study population in terms of gender and racial/ethnic group, and provides a rationale for selection of such subjects. A description of proposed outreach programs for recruiting women and minorities as participants also must be included. Additional specific instructions can be found in the PHS 398 Instructions at URL: http://grants.nih.gov/grants/funding/phs398/phs398.html under RESEARCH PLAN, Human Subjects Research Section. 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. 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: http://grants.nih.gov/grants/guide/notice-files/not98-024.html. Specifically, the investigator must include a section titled "Participation of Children." This section should provide either a description of the plans to include children and a rationale for selecting or excluding a specific age range of child, or an explanation of the reason(s) for excluding children as participants in the research. If children will be excluded from the research, the application must present an acceptable justification for the exclusion. Additional specific instructions and exclusion criteria can be found in the PHS 398 Instructions at URL: http://grants.nih.gov/grants/funding/phs398/phs398.html under RESEARCH PLAN, Human Subjects Research Section. 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 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. APPLICATION PROCEDURES 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 NIH staff. The research grant application form PHS 398 (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html is to be used in applying for these grants, with modular budget instructions beginning on page 13 of the application instructions. Applicants are permitted, however, to use the 4/1998 revision of the PHS 398 for scheduled application receipt dates until January 9, 2002. If you are preparing an application using the 4/1998 version, please refer to the step-by-step instructions for Modular Grants available at http://grants.nih.gov/grants/funding/modular/modular.htm. SPECIFIC R03 APPLICATION PROCEDURES The PHS 398 research grant application instructions and forms (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html are to be used in applying for these grants and will be accepted at the standard application deadlines (http://grants.nih.gov/grants/dates.htm) as indicated in the application kit. This version of the PHS 398 is available in an interactive, searchable PDF format. Although applicants are encouraged to begin using the 5/2001 revision of the PHS 398 as soon as possible, the NIH will continue to accept applications prepared using the 4/1998 revision until January 9, 2002. Beginning January 10, 2002, however, the NIH will return applications that are not submitted on the 5/2001 version. For further assistance contact GrantsInfo, Telephone 301/710-0267, Email: GrantsInfo@nih.gov. The specific R03 guidelines listed below (e.g., page limitations, number of copies, application dates) supersede the PHS 398 instructions. COVER PAGE: Item 2, type "Small Grant Program NIDCD" in "Title" box, and check the "YES" box, indicating the application is in response to a Program Announcement. For revised/amended applications, an introduction (not to exceed one and one- half pages) in addition to the research plan is required. This introduction, which is not included in the eight-page limit, should respond to the comments and concerns of the Initial Review Group delineated in the summary statement. Changes to the application’s Research Plan should be marked in the amended version. The research plan should not exceed eight pages. Information regarding specific aims, background and significance, preliminary studies/progress report, and research design and methods are all included in this eight-page limit. Up to three publications, submitted manuscripts, or abstracts may also be included as Appendix material. (Please refer to PHS 398 application for additional Appendix guidelines.) Letters of reference are not required. Applications that exceed the page limit or requirements for type/font size and margins may be returned to the investigator without review. (Please refer to PHS 398 application for details.) Use the mailing label in the application kit to mail the original (less Appendices) and three copies of the application (less Appendices) to: CENTER FOR SCIENTIFIC REVIEW NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, SUITE 1040 - MSC-7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) To ensure that the application is received in sufficient time for the review, please send an additional two copies 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, EPS Room 400-C, MSC 7180 Bethesda, MD 20892-7180 Rockville, MD 20852 (for express/courier service) The submission, review, and award schedule for the Small Grant Program through December 2004 is: Application Receipt Dates: Dec 17 Apr 22 Aug 20 NIDCD Committee Review: Feb/Mar Jun/Jul Oct/Nov Council Review: May Oct Jan Earliest Funding: Aug Jan May If the receipt date falls on a weekend, it will be extended to the following Monday, if the date falls on a holiday, it will be extended to the following business day. Only one Small Grant application may be submitted by a Principal Investigator per receipt date. Applicants may not submit an R01 application on the same topic concurrently (i.e., to be considered within the same review cycle) with the submission of a Small Grant application. REVIEW CONSIDERATIONS Applications will be reviewed for scientific and technical merit in accordance with the standard NIH procedures by an initial review group (IRG) 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 study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? 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? Does the applicant acknowledge potential problem areas and consider alternative tactics? (3) 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? (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 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? (6) Evaluate 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. (7) Evaluate the reasonableness of the proposed budget and the project’s duration in relation to the proposed research. (8) Evaluate 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. Applications will be subsequently reviewed by the National Deafness and Other Communication Disorders Advisory Council. AWARD CRITERIA Award criteria that will be used to make award decisions include: o scientific merit (as determined by peer review) o availability of funds o programmatic priorities. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Hearing Dr. Thomas Johnson Telephone: (301) 402-3461 Email: Thomas_Johnson@nih.gov Balance Dr. Daniel Sklare Telephone: (301) 496-1804 Email: Daniel_Sklare@nih.gov Smell/Taste Dr. Barry Davis Telephone: (301) 402-3464 Email: Barry_Davis@nih.gov Voice and Speech Dr. Lana Shekim Telephone: (301) 496-5061 Email: Lana_Shekim@nih.gov Language Dr. Judith Cooper Telephone: (301) 496-5061 Email: Judith_Cooper@nih.gov The address and FAX number for the above-named persons are: Scientific Programs Branch Division of Extramural Research National Institute on Deafness and Other Communication Disorders 6120 Executive Boulevard, EPS Room 400C, MSC-7180 Bethesda, MD 20892-7180 FAX: (301) 402-6251 Direct inquiries regarding fiscal matters to: Sara Stone Grants Management Office Division of Extramural Research National Institute on Deafness and Other Communication Disorders 6120 Executive Boulevard, EPS Room 400B, MSC-7180 Bethesda, MD 20892-7180 Telephone: (301) 402-0909 Fax: (301) 402-1758 Email: sara_stone@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 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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