NIDCD SMALL GRANT (R03) PROGRAM RELEASE DATE: February 13, 2004 PA NUMBER: PAR-04-062 March 2, 2006 (NOT-OD-06-046) Effective with the June 1, 2006 submission date, all R03, R21, R33 and R34 applications must be submitted through Grants.gov using the electronic SF424 (R&R) application. Accordingly, the portion of this funding opportunity relating to these mechanisms expires on the date indicated below. A Replacement R03 (PAR-06-263) funding opportunity announcement has been issued for the submission date of June 1, 2006 and submission dates thereafter. Other Related Notices: NOT-DC-06-002 and NOT-DC-05-003 EXPIRATION DATE: March 16, 2006 Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) (http://www.nih.gov) COMPONENT OF PARTICIPATING ORGANIZATION: National Institute on Deafness and Other Communication Disorders (NIDCD) (http://www.nidcd.nih.gov) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.173 APPLICATION RECEIPT DATES: 2004 April 22 July 15 Nov. 15 2005 March 15 July 15 Nov. 15 2006 March 15 July 14 Nov. 15 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 Special Requirements 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 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 NIDCD Small Grant (R03) Program is designed to support basic and clinical research of scientists who are in the early stages of establishing an independent research career. The Small Grant (R03) Program may be used to support individuals transitioning from postdoctoral status to their first independent research position. In addition, the Program 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. RESEARCH OBJECTIVES The Small Grant (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 typically within ten years of obtaining a terminal professional degree (e.g., M.A., Ph.D. or M.D.), excluding years spent in clinical training. Allowances are made for the years spent in clinical service delivery and heavy teaching responsibilities. 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 the amount of 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 a NIDCD mentored K-award may hold an R03 concurrently if additional research development support is needed to transition to independence. During the last two years of a mentored K-award, awardees may adjust their effort on the K-award in order to obtain salary support, as Principal Investigator, from a NIH research project grant, including an R03 grant, as per a recently adopted NIH policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-007.html). Additional details on these provisions and the availability of other types of research support to the K-awardee can be obtained from the NIDCD web site (http://www.nidcd.nih.gov/funding/types/careerdevt.asp). MECHANISM OF SUPPORT This PA will use the NIH R03 award mechanism. 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 budgeting format. (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 budget format. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm. Applications 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. 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 cannot exceed $50,000. 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 institutions/organizations o Faith-based or community-based institutions o Foreign institutions are not eligible to apply 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. Former recipients of Federally-funded National Research Service Award (NRSA) fellowships and traineeships or mentored career development awards are eligible for this R03 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 (e.g., NSF) are not eligible for the NIDCD Small Grant (R03) Program. Other questions about eligibility may be directed to one of the program officials listed under INQUIRIES. SPECIAL REQUIREMENTS The specific R03 guidelines listed below (e.g., page limitations, number of copies, application dates) supersede the PHS 398 instructions. New and amended applications submitted in response to this PA have the same receipt date. If a prior submission in response to the previous NIDCD R03 Small Grant PA, PA-01-126, was not funded and the investigator wishes to resubmit an application on the same topic in response to this PA, it is to be submitted as an amended (-A1) application using the current guidelines. An NIDCD R03 Small Grant is not renewable. 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. The research plan should not exceed ten pages. Information regarding specific aims, background and significance, preliminary studies/progress report, and research design and methods are all included in this ten-page limit. For revised/amended applications, an Introduction (not to exceed one page) in addition to the Research Plan is required. This Introduction, which is not included in the ten- page limit, must include responses to the criticisms and issues raised in the summary statement. The changes in the Research Plan must be clearly marked by appropriate bracketing, indenting or changing of typography, unless the changes include most of the text. Changes should be highlighted in the Introduction. Up to five 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 indicated above or requirements for type/font size and margins (refer to PHS 398 for details) may be returned to the investigator without review. 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 three areas: scientific/research, peer review, and financial or grants management issues: o Direct your questions about scientific/research issues to: Hearing: Dr. Amy Donahue Telephone: (301) 402-3458 Email: Donahuea@nidcd.nih.gov Dr. Nancy Freeman Telephone: (301) 402-3458 Email: Freemann@nidcd.nih.gov Dr. Lynn Luethke Telephone: (301) 402-3458 Email: Luethkel@nidcd.nih.gov Dr. Bracie Watson Telephone: (301) 402-3458 Email: Watsonb@nidcd.nih.gov Vestibular/Balance: Dr. Christopher Platt Telephone: (301) 402-3458 Email: Plattc@nidcd.nih.gov Taste/Smell: Dr. Barry Davis Telephone: (301) 402-3464 Email: Davisb1@nidcd.nih.gov Voice and Speech: Dr. Lana Shekim Telephone: (301) 496-5061 Email: Shekiml@nidcd.nih.gov Language: Dr. Judith Cooper Telephone: (301) 496-5061 Email: Cooperj@nidcd.nih.gov Research Training: Dr. Daniel Sklare Telephone: (301) 496-1804 Email: Sklared@nidcd.nih.gov The address and FAX number for the above-named persons are: Division of Scientific Programs National Institute on Deafness and Other Communication Disorders 6120 Executive Boulevard, EPS Room 400C, MSC-7180 Bethesda, MD 20892-7180 FAX: (301) 402-6251 o Direct your questions about peer review issues to: Melissa J. Stick, Ph.D., MPH Chief, Scientific Review Branch Division of Extramural Activities National Institute on Deafness and Other Communication Disorders 6120 Executive Blvd., Rm 400C Bethesda, Maryland, 20892-7180 Telephone: (301) 496-8683 FAX: (301) 402-6250 Email: Stickm@nidcd.nih.gov o Direct your questions about financial or grants management matters to: Sara Stone Chief, 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) 4021758 Email: stones@nidcd.nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). Applications must have a Dun and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The DUNS number can be obtained by calling (866) 705-5711 or through the web site at http://www.dunandbradstreet.com/. The DUNS number should be entered on line 11 of the face page of the PHS 398 form. 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) 710-0267, Email: GrantsInfo@nih.gov. The title and number of this program announcement must be typed on line 2 of the face page of the application and the YES box must be checked. SPECIFIC INSTRUCTIONS FOR MODULAR BUDGET GRANT APPLICATIONS: Applications requesting up to $250,000 per year in direct costs must be submitted in a modular budget grant format. The modular budget 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. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application (less the Appendix), 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) 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) APPLICATION PROCESSING: Applications must be received by the date listed on the first page. 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 unfunded version of an application already reviewed, but such application must include an Introduction addressing the previous critique. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NIDCD. Incomplete applications will not be reviewed. Applications that are complete and responsive to the PA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIDCD in accordance with the review criteria stated below. As part of the initial merit review, all applications will: 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 written critique o Receive a second level review by the NDCD 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 evaluate application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. The scientific review group will address and consider each of the following criteria in assigning the application’s overall score, weighting them as appropriate for each application. o Significance o Approach o Innovation o Investigator o Environment 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. 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? 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? 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? 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)? 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? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score: PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. (See criteria included in the section on Federal Citations, below). http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria in the sections on Federal Citations, below). CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to be used in the project, the five items described under Section f of the PHS 398 research grant application instructions (rev. 5/2001) will be assessed. ADDITIONAL REVIEW CONSIDERATIONS 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 The submission, review, and award schedule for the Small Grant Program through 2006 is: APPLICATION RECEIPT DATES: April 22, 2004 July 15, 2004 Nov 15, 2004 March 15, 2005 July 15, 2005 Nov 15, 2005 March 15, 2006 July 14, 2006 Nov 15, 2006 NIDCD Initial Review Panel: June/July Oct/Nov Feb/March Council Review: Sept Jan May Earliest Start Date: December April July REQUIRED FEDERAL CITATIONS HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm 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 "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://stemcells.nih.gov/index.asp 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, in the project description and elsewhere in the application as appropriate, 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. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health and Human Services (DHHS) issued final modification to the Standards for Privacy of Individually Identifiable Health Information , the Privacy Rule, on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR). Those who must comply with the Privacy Rule (classified under the Rule as covered entities ) must do so by April 14, 2003 (with the exception of small health plans which have an extra year to comply). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on Am I a covered entity? Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.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. 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.healthypeople.gov/. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm. 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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