Full Text DE-96-004 DEVELOPMENTAL GRANTS: COMPREHENSIVE ORAL RESEARCH CENTERS NIH GUIDE, Volume 25, Number 13, April 26, 1996 RFA: DE-96-004 P.T. 04 Keywords: Oral Diseases Dentistry Biomedical Research, Multidiscipl National Institute of Dental Research Letter of Intent Receipt Date: August 15, 1996 Application Receipt Date: November 14, 1996 PURPOSE The National Institute of Dental Research (NIDR) invites applications for Developmental Grants to support the planning of multidisciplinary Comprehensive Oral Health Research Centers of Discovery (COHRCDs). The aim of the COHRCD program is to support the full range of outstanding multidisciplinary research on oral, dental and craniofacial diseases and disorders. Each COHRCD will be organized around an unifying scientific theme pertinent to these diseases and disorders and will be expected to: include projects encompassing basic research as well as translational and applied research including behavioral, health services, and clinical research; accelerate transfer of research findings to application by health professionals and the public and facilitate the development of marketable products; support demonstration research and outreach programs; and enhance the training of health professionals and the public concerning health promotion and the prevention, improved diagnosis and treatment of specific oral, dental, and craniofacial diseases and disorders. The one year planning grant is expected to lead to the development of an organizational infrastructure necessary for the establishment of a COHRCD and the eventual submission of an application to support its activities. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Developmental Grants: Comprehensive Oral Research Centers, is related to the priority area of oral health. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-00100473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). 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. Foreign organizations are not eligible to apply. However, domestic applications may include international components. The NIDR encourages applications that include investigators who are racial/ethnic minority individuals, women and persons with disabilities. Although an application must be submitted from a single institution, collaborative arrangements with other institutions are strongly encouraged. Also, applications are not restricted to traditional oral, dental, and craniofacial research settings. MECHANISM OF SUPPORT This RFA will use the Developmental Grant (P20) mechanism. Choice of an appropriate theme and the planning, direction, and execution of the proposed project are solely the responsibility of the applicant. This RFA is a one-time solicitation with an anticipated award date of July 1997. FUNDS AVAILABLE It is expected that the NIDR will allocate approximately $2.0 million to support developmental grants with a budget limit of $100,000 direct costs each during FY 97, provided that the applications received are of high scientific merit. The $100,000 direct costs cap includes any indirect costs that are part of subcontract costs. Although this program is provided for in the financial plans of the NIDR, the award of grants pursuant to this RFA is also contingent upon the availability of funds for this purpose. Policies that govern research grant programs of the National Institutes of Health (NIH) will prevail. RESEARCH OBJECTIVES Background Over the past four decades, the NIDR has championed the creation of centers to foster basic science research in dental school environments, to intensify a focus on several important infectious oral diseases, and more recently to broaden the scope of dental research. These efforts have increasingly advanced the mission of the NIDR and continue to evolve. Now, as we approach the 21st Century, new science opportunities are readily apparent in a climate of major national changes in health care management, especially with respect to university health science centers. It is further evident that most important human diseases require a paradigm that includes integration among behavioral, environmental, and biological sciences [e.g., inherited craniofacial-oral-dental diseases and disorders, acquired craniofacial-oral-dental diseases and disorders (i.e., emerging and re-emerging infectious diseases, neoplastic diseases, and chronic disabling diseases and disorders such as osteoporosis and related bone disorders, temporomandibular joint disorders, neuropathies and neurodegenerative diseases)]. It is also evident that increased collaborations, partnerships and leveraging funding are essential to maximize exemplary science and patient-oriented opportunities. Regarding the latter, the NIDR has previously provided only limited support for demonstration research, a necessary component for testing the effectiveness and efficacy of many types of interventions, and an area recommended by an advisory panel that reviewed NIDR's Centers Grant Program in 1985. Goals It is the intent of this RFA to offer support for collaborative planning and development of the organizational infrastructure necessary for a COHRCD. Scientific areas covering a wide spectrum of coordinated research efforts, from laboratory studies to outreach and demonstration research programs, should be identified as should key personnel and resources. Organizational plans and agreements should be established. In these planning efforts, applicants are strongly encouraged to identify and, where possible, secure commitments for complementary resources that would expand the potential scientific yield of COHRCD activities. Objectives It is anticipated that the COHRCD program will focus on the need to broaden the expertise and approaches taken in addressing major research themes within the mission of the NIDR. Specifically, the NIDR is interested in supporting thematic research conducted by groups of outstanding scientists who have distinguished themselves in their own areas of investigation. These activities would span the entire range of research approaches possible under the umbrella of a comprehensive center supported through the P60 mechanism at an initial funding level of no more than $1.5 million in direct costs per center. The objectives of these centers should typically include: (1) fostering integrated biomedical, behavioral, social science, and health services research and development at the fundamental, clinical and applied levels; (2) initiating and expanding research on community education, screening, counseling and related services programs; and (3) promoting research related to education of health professionals and the public concerning the etiology, prevention, diagnosis and treatment of oral, dental and craniofacial diseases. Award of a COHRCD is typically indicative of the fact that the applicant group and the research they propose is at a level of excellence unparalleled in a field. A COHRCD can be located within a single institution or, preferably, may involve consortia with other institutions such as universities, research institutes, hospitals, computer facilities, regional centers, health departments, industry and primate centers. These comprehensive centers may include free-standing specialized centers, program projects, and investigator-initiated research projects as integral components and could typically include research cores, newly proposed research projects, support for feasibility studies and support for demonstration and outreach research. Support will not be provided for routine patient care costs or training expenses. The strength of the COHRCDs lies in the fact that, as thematically-based organizations, they will be capable of incorporating the full range of expertise from basic to clinical research studies, clinical trials and demonstration research. Each COHRCD must be a clearly defined organizational entity with a director responsible for management of the center. Strong and effective scientific leadership must be provided. The director will be responsible for the organization and operation of the center and for communication within the center and with the NIDR on scientific and administrative matters. Directors will be responsible for maintaining high quality research efforts and for ensuring effective collaboration among scientists and cooperating institutions. The COHRCDs will be organized around a central theme, the choice of which is the responsibility of the applicant but which must be within the mission of the NIDR. Five organizational components are required: (1) a biomedical, behavioral, social science and health services research base; (2) a demonstration research component that will, among other things, provide a means for developing effective and efficient outreach and community liaison functions; (3) a component that facilitates and manages research concerning education of health professionals and future scientists as well as the immediate and extended communities within which the center resides; (4) a technology transfer component that would support developmental activities to move fundamental and clinical research findings from the laboratory to the marketplace; and (5) administrative and research support cores, including biostatistics, appropriate to the focus of the research. 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 is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. The policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies concerning the inclusion of minorities in study populations which have been in effect since 1990. The policy contains some provisions that are substantially different from the 1990 policies. 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 reprinted in the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18, 1994. Investigators may obtain copies from these sources or from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by August 15, 1996, a letter of intent that includes a descriptive title for the COHRCD Developmental Grant; the name, address, FAX, email address, and telephone number of the Center director; and the identities of other key personnel and potential participating institutions and departments. 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 is helpful in planning for the timely review of the applications. It allows NIDR staff to estimate the potential review workload and to avoid possible conflicts of interest in the review. The letter of intent is to be addressed to Dr. Ann Sandberg at the address listed under INQUIRIES. APPLICATION PROCEDURES Prospective applicants are encouraged to communicate with program and grants management staff of the NIDR's Division of Extramural Research as early as possible in the planning phase of application preparation. Advice and suggestions by staff may materially assist applicants to ensure that the COHRCD Developmental Grant's objectives, structure and budget format are acceptable. Applications are to be prepared on the grant application form PHS 398 (rev.5/95). Applications kits are available at most institutional offices of sponsored research and may be obtained from the Grants Information Office, Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267, email: ASKNIH@odrockm1.od.nih.gov. The RFA label available in the PHS 398 application form kit must be affixed to the bottom of the face page of the original and the original must be placed on top of the entire package. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, in order to identify the application as a response to this RFA, the RFA title (Developmental Grants: Comprehensive Oral Research Centers) and number DE-96-004 must be typed in item 2 of the face page of the application form and the YES box must be checked. The instructions accompanying form PHS 398 must be followed. Submit a signed, typewritten original of the application, including a cover letter (if appropriate), the checklist, and three signed photocopies, in one package to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must also be sent to: Dr. H. George Hausch Division of Extramural Research National Institute of Dental Research Natcher Building, Room 4AN-38D 45 Center Drive MSC 6402 Bethesda, MD 20892-6402 Applications must be received by November 14, 1996. If an application is received after that date, it will be returned to the applicant without review. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the Division of Research Grants (DRG) and responsiveness by the NIDR. Incomplete applications or those that exceed the budget limit of $100,000 direct costs will be returned to the applicant without further consideration. Waivers of the receipt deadline and budget limitation will not be granted. If NIDR staff find that the application is not responsive to the RFA, it will be returned without further consideration. Applications that are complete and responsive to the program announcement will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the National Advisory Dental Research Council. Factors to be considered in the evaluation of the applications are: o the plan for developing the organizational infrastructure to support and operate the COHRCD; o the institutional or multi-institutional environment, the institution's (s') commitment to the COHRCD, and evidence of an organizational structure that will promote multidisciplinary and collaborative basic, translational and applied research; o the scientific and administrative qualifications, experience and commitment of the COHRCD director and his/her ability to provide effective leadership; o the qualifications of the key personnel; o evidence that the COHRCD will pursue commitments for complementary resources; o evidence that the COHRCD will be able to establish partnerships with organizations that can provide educational and outreach activities; o evidence that collaborations among basic, translational and applied research areas will facilitate and accelerate the transfer of laboratory findings to innovative and productive studies involving patients and populations either within the COHRCD or through outside collaborations with other institutions and/or industry; o evidence of the availability of appropriate study populations and ability of the COHRCD to recruit adequate samples consistent with the NIH guidelines; and o the plan for evaluating and monitoring the organizational infrastructure and productivity for each of the components and the entire COHRCD. AWARD CRITERIA The earliest anticipated date of award is July 1997. Applicants should be aware that, in addition to scientific merit, program priorities and program balance, the total cost of the proposed project and the availability of funds will be considered by the NIDR staff and the National Advisory Dental Research Council in making funding recommendations. In addition, the NIDR values complementary funding from other public and private sources including foundations and industrial concerns. In circumstances in which applications have similar scientific merit, but vary in cost-competitiveness, the NIDR is likely to select the more cost-competitive application for funding. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Dr. Ann Sandberg Division of Extramural Research National Institute of Dental Research Natcher Building, Room 4AN-24A 45 Center Drive MSC 6402 Bethesda, MD 20892-6402 Telephone: (301) 594-2419 FAX: (301) 480-8318 Email: Ann.Sandberg@nih.gov Direct inquiries regarding grants management issues to: Mr. Martin R. Rubinstein Division of Extramural Research National Institute of Dental Research Natcher Building, Room 4AN-44A 45 Center Drive, MSC 6402 Bethesda, MD 20892-6402 Telephone: (301) 594-4800 Email: Martin.Rubinstein@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.121. 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 amd 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 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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