COMPREHENSIVE ORAL HEALTH RESEARCH CENTERS OF DISCOVERY NIH GUIDE, Volume 26, Number 25, August 1, 1997 RFA: DE-97-002 P.T. 04; K.W. 0715048, 0710030 National Institute of Dental Research Letter of Intent Receipt Date: March 1, 1998 Application Receipt Date: May 8, 1998 THIS REQUEST FOR APPLICATIONS (RFA) IS A REVISION OF THE RFA APPEARING IN THE MAY 30 ISSUE OF THE NIH GUIDE. THIS REVISION CORRECTS THE RESEARCH OBJECTIVES SECTION IN THE FULL TEXT OF THE RFA. PURPOSE The National Institute of Dental Research (NIDR) invites applications for Comprehensive Oral Health Research Centers of Discovery (COHRCD). Each COHRCD will be organized around an unifying scientific theme related to dental, oral and craniofacial diseases and disorders. Individual COHRCDs will encompass a full range of outstanding multidisciplinary research pertinent to these diseases and disorders and will be expected to: include basic, translational and applied research projects with behavioral, health services and clinical research components; accelerate transfer of research findings to application by health professionals and the public as well as to facilitate the development of marketable products and other effective health promoting interventions; support research concerning demonstration and outreach programs; and enhance the training of health professionals and the public concerning health promotion and the prevention, improved diagnosis and treatment of the dental, oral or craniofacial diseases and disorders relating to the chosen theme. 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 Request for Applications (RFA), Comprehensive Oral Health Research Centers of Discovery, 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. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (Telephone: 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by all domestic for-profit and non- profit organizations, public and private, including universities, colleges, hospitals, laboratories, units of State and local governments and eligible agencies of the Federal government. Applicants need not have submitted proposals or been awarded funds for the developmental grants for these centers (RFA: DE-96-004) nor are applicants required to use the same central theme as the one that may have been supported through the developmental grants. 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 dental, oral and craniofacial research settings. MECHANISM OF SUPPORT The mechanism for the support of applications in response to this RFA is the Comprehensive Center (P60). Choice of an appropriate theme and the direction and execution of the proposed activities are solely the responsibility of the applicant. This RFA is a one- time solicitation by NIDR and applicants may apply for and receive up to five years of support. The earliest possible award date will be May, 1999. FUNDS AVAILABLE It is anticipated that the NIDR will allocate approximately $16.5 million to support seven COHRCDs provided that sufficient applications of high scientific merit are received. The direct costs requested for the initial year of these applications may not exceed $1.5 million. The $1.5 million direct cost limit includes any indirect costs associated with subcontracts listed as part of the application. Requested increases in direct costs for subsequent years may not exceed 3 percent. Although support for this program is provided for in the financial plans of the NIDR, the award of grants pursuant to this RFA is contingent upon the availability of appropriated funds. Policies that govern research grant programs of the National Institutes of Health (NIH) will prevail. RESEARCH OBJECTIVES Background The NIDR has very effectively utilized the center concept to advance research in oral biology, periodontology, cariology, craniofacial anomalies, aging and materials science. Specialized research centers were designed to intensify research in these areas and have been and continue to be successful in accomplishing this aim. However, it is becoming increasingly apparent that future meaningful insights concerning the mechanisms involved in the induction and progression as well as in the prevention, diagnosis and treatment of dental, oral and craniofacial diseases and disorders must consider not only basic research but also extensive integration of basic, clinical and behavioral sciences; health services and epidemiologic research as well as demonstration, education and outreach activities. The establishment of the COHRCDs addresses this need to accommodate all aspects of certain dental, oral and craniofacial disease processes by stimulating increased collaborations, partnerships and leveraged funding. It is an opportune time to implement this expansive approach to optimally utilize the current rapid advances being made in biomedical and behavioral sciences. To redirect efforts towards the far-reaching aims described in this RFA, a previous RFA (DE-96- 004, Developmental Grants: Comprehensive Oral Research Centers) announcing support to develop plans for these centers was issued. Goals and Objectives It is the intent of the current RFA to provide support for COHRCDs. These comprehensive centers will broaden the expertise available and approaches taken in addressing major research themes within the mission of the NIDR. Choice of the theme is the responsibility of the applicant. The objectives of the COHRCDs are to: (1) foster integrated biomedical, behavioral, social science and health services research and development at the fundamental, clinical and applied levels and to facilitate transfer of the acquired findings to marketable products and other effective health promoting interventions; (2) initiate and expand research on community education, screening, counseling and related services programs; and (3) promote research related to education of health professionals and the public concerning the etiology, prevention, diagnosis and treatment of dental, oral and craniofacial diseases and disorders. Five organizational components are required for each COHRCD: (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 products and processes from the laboratory to the marketplace; and (5) administrative and research support cores, including biostatistics, appropriate to the focus of the research. While a strong base of biomedical or behavioral research is an essential prerequisite, all components indicated above need not be developed to the same degree, acknowledging the variety of strengths present within a given group of researchers. Details of the various components of the COHRCDs including all collaborating units as well as acquisition of complementary funding to expand the potential scientific yield of each center must be addressed. Shared resources will be used to enhance productivity, stimulate collaborative efforts and increase cost effectiveness. Award of a COHRCD indicates that the applicant group and the research they propose is at a level of excellence unparalleled in a field. A COHRCD might be located within a single institution but, preferably, would 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 needed to accomplish the desired objectives. Each COHRCD must be a clearly defined organizational entity with a Director responsible for management of the center. Evidence of his/her strong and effective scientific leadership must be provided. The Director will be responsible for the organization and operation of the center, for communication within the center and with the NIDR on scientific and administrative matters, for maintaining high quality research efforts and for ensuring effective collaboration and communication among scientists and cooperating institutions. 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. 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 "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, Vol. 23, No. 11, March 18, 1994. LETTER OF INTENT Prospective applicants are asked to submit, by March 1, 1998, a letter of intent that includes the number and title of this RFA and a descriptive title for the COHRCD grant. Potential applicants also are asked to provide the name, mailing address, FAX, email address and telephone number of the Center Director and the identities of other key personnel and 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 estimating the potential review workload and avoiding conflict of interest in the review. The letter of intent is to be sent to Dr. Ann L. Sandberg at the address listed under INQUIRIES. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 5/95) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research and may be obtained from the Division 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@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 (Comprehensive Oral Health Research Centers of Discovery) and number DE-97-002 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 as far as possible. Submit a signed, typewritten original of the application, including a cover letter, 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 May 8, 1998. 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 DRG and responsiveness by the NIDR. If NIDR staff finds that the application is not responsive to the RFA, is incomplete or exceeds the direct cost limit, it will be returned without further consideration. Waivers of the receipt deadline and budget limitation will not be granted. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIDR in accordance with the review criteria stated below. As part of the initial merit review, applications may be subjected to a streamlined review process to determine their scientific merit relative to other applications received in response to the RFA. The NIDR will withdraw those judged to be in the bottom tier of applications. Those determined to be competitive will be evaluated for scientific and technical merit by the review committee. Secondary review of the applications will be conducted by the National Advisory Dental Research Council. Factors to be considered in the evaluation of the applications include: o institutional (preferably multi-institutional) environment and the institution's(s') commitment to the COHRCD; o evidence of an organizational structure that will promote interdisciplinary and multifactorial research that includes all of the required components; o potential impact of proposed activities on future health benefits within the chosen thematic area; o scientific and administrative qualifications, experience and commitment of the COHRCD director as well as his/her ability to provide effective leadership and the arrangements for an assistant director to administer the center in the director's absence and replace the director should it become necessary; o qualifications of the key personnel; o evidence of the establishment of effective collaborations among COHRCD investigators, cores and other groups (public health organizations, other institutions, etc.); o scientific excellence of the proposed COHRCD's basic, clinical, health services and behavioral research base as well as other components which applicants may wish to include (e.g., epidemiologic research); o appropriateness and relevance of the cores, their modes of operation and the suitability of their facilities; o the provision of an environment conducive to training of health professionals; o approach and potential effectiveness of outreach research; o evidence that the COHRCD will be able to establish partnerships with other research organizations and agencies that can provide educational and outreach activities; o feasibility of success of the demonstration research; o evidence of the availability of appropriate study populations and ability of the COHRCD to recruit adequate samples consistent with the NIH guidelines; o evidence of the ability to develop potentially marketable products and other effective interventions; o appropriateness of the budget for the proposed activities; o ability to obtain and effectively utilize leveraged funding; and o a plan for monitoring and evaluating the productivity of each of the components and the entire COHRCD. AWARD CRITERIA The earliest anticipated date of award is May, 1999. 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, email 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 L. 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 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 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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