RESEARCH CORE CENTERS (P30) FOR THE NIDCD Release Date: November 2, 2000 PA NUMBER: PA-01-011 National Institute on Deafness and Other Communication Disorders (http://www.nidcd.nih.gov/) Application Receipt Dates: February 1, June 1, and October 1, 2001, 2002, 2003 Letter of Intent Receipt Dates: December 1, 2000, April 1, August 1, and December 1, 2001, 2002, and 2003 Application procedures are outlined in the NIDCD Guidelines for Research Core Centers (P30) which can be obtained on the NIDCD Home Page at http://www.nidcd.nih.gov/funding/types/p30_2003.pdf. PURPOSE The National Institute on Deafness and Other Communication Disorders (NIDCD) invites grant applications from basic and clinical investigators for Research Core Centers (P30). The Research Core Center (P30) is an institutional award, made in the name of a principal investigator, to support centralized resources and facilities shared by investigators with existing research projects. The overall goal of a Core Center is to promote a cooperative interaction among basic science and/or clinical investigators in a manner that will enrich the effectiveness of ongoing research and promote new research directions. This announcement supercedes Research Core Centers (P30) for the NIDCD, PAR-99-129 released July 13, 1999 and Errata: Research Core Centers (P30) for the NIDCD, Notice DC-00-001 released October 21, 1999. 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 "Research Core Centers (P30) for the NIDCD" 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/. HP2010 includes a new chapter on vision and hearing [#28]. A copy of this chapter may be obtained at: http://www.health.gov/healthypeople/Document/HTML/Volume2/28Vision.htm. 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 not allowed. Any institution or consortium with an active program of basic and/or clinical biomedical research in the mission areas of the NIDCD may qualify for support through a Core Center. Institutions applying for a Core Center grant must hold, on the date of grant application submission, a minimum of four research project grants each with at least one year of support remaining. Research projects associated with a Core Center include individual research grants (R01), FIRST awards (R29), or similar peer-reviewed project funding from other Federal agencies. A current program project/center grant (P01 or P50) subproject may count toward the minimum of four if that subproject will be an extensive user of one of the proposed research cores. At least 75% of the research project base must be supported by the NIDCD and focus on NIDCD mission areas. Training grants (F32/T32), career development awards (e.g., K08/K23), small grants (R03) and feasibility awards (R21) do not count as part of the requisite research base, but can be users of the Core Center. One or more meritorious research core(s) must be proposed. Each research core must have extensive usage by a minimum of three investigators with peer reviewed projects that are independently funded. A Core Center must be an identifiable organizational unit either within a single grantee institution or representing a consortium of cooperating institutions (e.g., geographic or web-based). Joint applications may be submitted by investigators at neighboring, independent, or multi-campus institutions. MECHANISM OF SUPPORT Support for this program will be provided through the National Institutes of Health (NIH) Research Core Center (P30) mechanism. This initiative provides awards for up to five years of support. RESEARCH OBJECTIVES The mission of the National Institute on Deafness and Other Communication Disorders (NIDCD) is to support research and research training on normal processes as well as diseases and disorders of hearing, balance, smell, taste, voice, speech and language. To achieve this mission, NIDCD employs a number of support mechanisms. NIDCD recognizes the value of core services in promoting interactive and collaborative research. The Research Core Center (P30) is an institutional award, made in the name of a principal investigator, to support centralized resources and facilities shared by investigators with existing research projects. Its aim is to stimulate multidisciplinary approaches to joint research efforts. It should be an intellectual hub around which cooperative and interactive research will be supported and stimulated. The overall goal of a Core Center is to promote a cooperative interaction among basic and/or clinical investigators in a manner that will enrich the effectiveness of ongoing research and promote new research directions. The use of shared resources can increase the efficiency of research by eliminating unnecessary duplication, promoting the development of new research directions, and promoting research interactions and collaborations. Research cores should be designed to furnish a group of investigators some service, technique, assay, or instrumentation in a manner that will enhance the research in progress. Although no funds are provided for direct support of research projects, a Core Center helps to integrate and promote research in existing projects. This support is intended to enhance the productivity of traditional research grants at the institution and thereby improve the research capability of the community and health of the nation. 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 sub-populations 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 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 research involving human subjects should read the UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html), a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm: The revisions relate to NIH defined Phase III clinical trials and require: a) all applications or proposals and/or protocols to 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) all investigators to report accrual, and to conduct and report analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. 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. 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 for 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. LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes a descriptive title of the proposed research, the name, address and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the PA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NIDCD staff to estimate the potential review workload and plan the review. The letter of intent is to be sent to Dr. Amy M. Donahue at the address listed in INQUIRIES by the letter of intent receipt date listed. APPLICATION PROCEDURES Application procedures are outlined in the NIDCD Guidelines for Research Core Centers (P30) which can be obtained on the NIDCD Home Page at http://www.nidcd.nih.gov/funding/types/p30_2003.pdf or from program staff listed in INQUIRIES. The PHS 398 (revised 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: 301/710-0267, email: GrantsInfo@nih.gov. The instructions in the PHS 398 application kit must be adhered to, except where they have been modified by the NIDCD Guidelines for Research Core Centers (P30). Core Center grants are not one of the mechanisms included in NIH’s Modular Grants initiative. A detailed budget must be provided. The completed original application and three copies must be submitted 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) Send two additional copies of the application, and five sets of any appendices (see the NIDCD’s Guidelines for Research Core Centers for further information on appendix submission) to: Chief, Scientific Review Branch National Institute on Deafness and Other Communication Disorders 6120 Executive Boulevard, Room 400-C, MSC 7180 Bethesda, MD 20892-7180 SUBMISSION OF APPLICATIONS Applications will be accepted under these guidelines beginning with the February 1, 2001 application receipt date through the October 1, 2003 date. The receipt dates are the same for all new (Type 1), renewal (Type 2), and supplemental (Type 3) P30 applications. Letter of Intent: December 1 April 1 August 1 Application Receipt Dates: February 1 June 1 October 1 NIDCD Committee Review: June October February Council Review: September January May Earliest Funding: January 1 April 1 August 1 REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NIDCD. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive 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 review, all applications will be discussed and receive a written critique. Those applications deemed to have the highest merit, generally the top half of applications under review, will receive a second level of review by the NDCD Advisory Council. As part of the initial scientific review, reviewers will rate the Core Center and each individual research core, the scores will appear in the summary statement. Since the NIDCD is interested in funding only the best research, individual cores of lesser quality (for example, those falling below the score of fundable Core Center applications) may not be funded, even if recommended under the umbrella of the Core Center grant application. Each individual core must fit in and contribute to the overall Core Center and each application should be complete in itself. Site visits are not anticipated. Review Criteria for Individual Research Cores Individual research cores are evaluated on the facilities/services provided, their utility, and their ability to fulfill the goals of the Core Center program. Important factors include: Significance of the core support to the research base (must be used by at least three independently funded investigators). The quality of services provided, the discussion of quality control procedures, evidence that the core offers cost effective services, and the discussion of cost reimbursement plans. The potential for the core to promote collaborative research, and the plans to offer unique and/or cutting edge services. Training and suitability of the core director and personnel, the commitment of the investigators, and the ability to devote the required time and effort to the core. Adequacy of the facilities, equipment and institutional commitment to the core. In addition to these criteria, in accordance with NIH policy, all applications will be reviewed with respect to the following: The adequacy of plans to include children, both genders, 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. The reasonableness of the proposed budget and duration in relation to the proposed research. 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. Overall Core Center Evaluation An overall priority score will be assigned to the application. This score will reflect not only the quality of the individual cores, but also plans for leadership and administration, the quality of the research base and how the proposed Core Center will enhance the research base. The following elements will be evaluated: Leadership and Administration: The plans for coordination of ongoing research between the separately funded projects and the Core Center including mechanisms for internal monitoring. The management proposed for fiscal administration, procurement, property and personnel management, planning, budgeting, etc. The plan for the establishment and maintenance of internal communication and cooperation among the Core Center investigators. Appropriate scientific and administrative leadership, and time commitment of the Core Center Director and Associate Director for the effective management of the Core Center program. The overall environment for a Core Center. This includes the institutional commitment to the program, management accountability, and the institution’s partnership with the Core Center. This also includes the academic environment and resources supporting the activities to be conducted, such as space, equipment, facilities, and the potential for interaction with scientists from other departments and schools. Research Base and Enhancement by the Core Center The aggregate quality of the Core Center’s research base as well as the relevance and interrelation of these separately funded research projects to the central themes of the Core Center. The likelihood for meaningful collaboration among Core Center investigators. This includes demonstrated interactions and interrelationships of the research efforts as well as plans to further develop productive interdisciplinary collaborations among Core Center investigators. Ability of the Core Center to significantly enhance (further extend, stimulate and provide added dimension to) the established research base of the host institution. 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, relevance to the mission of the NIDCD, program priorities, and availability of funds. INQUIRIES Individuals from institutions with potential interest in applying for a Core Center grant are strongly advised to discuss the potential application with the NIDCD staff members identified below and make program staff contact as early as possible in the application preparation process. Direct inquiries regarding programmatic issues, including eligibility and responsiveness, to: Amy M. Donahue, Ph.D. Division of Extramural Research National Institute on Deafness and Other Communication Disorders 6120 Executive Boulevard, Room 400-C, MSC-7180 Bethesda, MD 20892-7180 Telephone: (301) 402-3458 Fax: (301) 402-6251 Email: amy_donahue@nih.gov Direct inquiries regarding fiscal matters to: Ms. Sherry Dabney 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: sherry_dabney@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 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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