EXPLORATORY/DEVELOPMENTAL RESEARCH: FEASIBILITY PILOT STUDIES RELEASE DATE: March 21, 2002 PA NUMBER: PAR-02-088 EXPIRATION DATE: July 15, 2002, unless reissued National Institute on Deafness and Other Communication Disorders (NIDCD) (http://www.nidcd.nih.gov) APPLICATION RECEIPT DATE: July 15, 2002 THIS PROGRAM ANNOUNCEMENT (PA) CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Research Objectives o Mechanism of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Where to Send Inquiries o Submitting an Application o Sending an Application to the NIH o Research Plan o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citation PURPOSE The NIDCD invites applications for innovative, initial feasibility pilot studies focused on hearing, balance, smell, taste, voice, speech, and language, the scientific mission areas of the NIDCD. The proposed research should involve the testing of novel hypotheses or the application of new techniques or methodologies at an early stage of development. These novel ideas may differ substantially from current thinking and practice and may have an uncertain outcome because sufficient experimental data are unavailable. Applications submitted under this mechanism should be innovative with a potential to have a major impact on a field of biomedical research by breaking new ground or by extending previous discoveries toward new directions. It is intended that, if promising, the additional 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). RESEARCH OBJECTIVES The purpose of this program announcement (PA) is to encourage investigators working within and outside the communication sciences to submit feasibility pilot studies within the scientific mission areas of the NIDCD. This PA supersedes an expired NIDCD PA: Exploratory Research: Feasibility Pilot Studies, PAR-01-103. The current PA supports the initial feasibility studies that will test novel ideas or the application of new techniques or methods at an early stage in their development, and may contribute substantially to our understanding of the communication sciences. Such areas of investigation typically lack a historical base of scientific data (e.g., a body of peer- reviewed publications) and, therefore, would require pilot studies to generate the amount of pilot data that is needed for the submission of a regular research grant. The proposed project may be related to an ongoing research program or may involve a new area of research for the laboratory. The NIDCD encourages applications from investigators conducting research outside the communication sciences who possess expertise with methodological approaches that have not been typically applied to but which would greatly promote scientific progress within the communication sciences. The amount of pilot data that typically accompanies an R01 application is not required as a part of the NIDCD EXPLORATORY/DEVELOPMENTAL RESEARCH grant mechanism. Nonetheless, the applicant has the responsibility to provide sufficient pilot data to demonstrate the soundness and feasibility of the research plan. Past experiences have shown that it is difficult to evaluate the scientific merit of applications during initial review if insufficient pilot data are provided. In cases involving a change in research focus or direction for the laboratory, the appropriate expertise of key personnel and collaborators to pursue such novel research must be evident. The NIDCD EXPLORATORY/DEVELOPMENTAL RESEARCH grant mechanism is open to all investigators, whether newly independent or established. However, the NIDCD strongly encourages newly independent individuals who are starting their first independent research program to seek support through the NIDCD Small Grant (R03) funding mechanism. The NIDCD R03 mechanism is designed to support a new research program at an early stage of development during the transition to independence. The newly independent applicant is urged to contact the appropriate program director during the planning stages of an application. It is anticipated that applications submitted by established investigators in response to this PA will seek support to pursue new ideas that require pilot data and that fall outside the scope of existing research projects. MECHANISM OF SUPPORT This PA 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. The current PA offers nonrenewable awards for up to two years of support and up to $100,000 per year in direct costs to support exploratory research where sufficient pilot data to support a regular research grant application are lacking. Areas of the communication sciences with sufficient existing preliminary data to support the submission of a regular research grant application do not qualify under this PA. An individual may submit only one application as the principal investigator. This PA uses just-in-time concepts. It also uses the modular budgeting format. (see https://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each of $250,000 or less, use the modular format. Submission of an application under this PA 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. 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. 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: amy_donahue@nih.gov Dr. Nancy Freeman Telephone: (301) 402-3458 Email: amy_donahue@nih.gov Dr. Thomas Johnson Telephone: (301) 402-3461 Email: thomas_johnson@nih.gov Dr. Lynn Luethke Telephone: (301) 402-3458 Email: lynn_luethke@nih.gov Balance: Dr. Daniel Sklare Telephone: (301) 496-1804 Email: daniel_sklare@nih.gov Taste and Smell: Dr. Barry Davis Telephone: (301) 402-3464 Email: barry_davis@nih.gov Language: Dr. Judith Cooper Telephone: (301) 496-5061 Email: judith_cooper@nih.gov Voice and Speech: Dr. Lana Shekim Telephone: (301) 496-5061 Email: Lana_Shekim@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 Rockville, MD 20892-7180 FAX: (301) 402-6251 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: 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 Rockville, MD 20892-7180 Telephone: (301) 402-0909 FAX: (301) 402-1758 Email: CM249E@nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at https://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. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the checklist, and five signed photocopies in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) The title, EXPLORATORY/DEVELOPMENTAL RESEARCH: FEASIBILITY PILOT STUDIES, and the number of this announcement, PAR-02-XXX, 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) The submission, review, and award schedule is: Application Receipt Date: July 15, 2002 NIDCD Committee Review: October/November, 2002 Council Review: January, 2002 Earliest Funding: April, 2003 APPLICATION PROCESSING: Applications must be received by or mailed before the receipt date listed on the face page of the PA. The Center for Scientific Review (CSR) will not accept any application in response to this PA that is essentially the same as one currently pending initial review unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such an application must include an Introduction addressing the previous critique. RESEARCH PLAN: Do not exceed a total of 10 pages for the Research Plan. This limitation includes the introductory justification paragraph that is described below, as well as tables and figures. Enlarged glossy color photographs, electron micrographs, or photographs of gels may be included in the Appendix. However, tables or figures included in the Appendix must also appear within the page limitations of the Research Plan but may be reduced in size. Justification as Exploratory/Developmental Research Applications that lack an acceptable introductory justification paragraph will be returned to the applicant without undergoing initial peer review. Amply justify the designation of the application as a feasibility pilot study in an introductory paragraph at the beginning of the research plan. Label this paragraph, "Justification as Exploratory/Developmental Research." Do not incorporate the justification within the main text of the research plan. Explain how this project represents a test of novel ideas that require pilot studies, justify why the project would not be appropriate for submission as a regular research grant at this time, and how this project, if fruitful, would enable you to craft a research program appropriate for submission as a full- scale research grant application. If you are a newly independent investigator, justify how this project differs from the main research program currently in development in the laboratory and why this project is not suitable for the NIDCD Small Grant (R03) funding mechanism. NIDCD staff will use the justification paragraph to determine whether the application is responsive to the goals of this PA. Non-responsive applications will be returned to the applicant without undergoing initial peer review. The applications submitted in response to this PA 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 PA 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 (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 applications or applications failing to comply with NIH grant format guidelines (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-037.html) will be returned. Complete and complying 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 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 both genders, 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? 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 PA will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: o Scientific merit of the proposed project as determined by peer review o Availability of funds o Relevance to program priorities REQUIRED FEDERAL CITATIONS: 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 (https://grants.nih.gov/grants/guide/notice- files/NOT-OD-02-001.html), a complete copy of the updated Guidelines are available at https://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.ht m. 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 https://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 https://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 https://grants.nih.gov/grants/stem_cells.htm and at https://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 https://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. https://grants.nih.gov/grants/guide/pa-files/PA-02-015.html.

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