CLARIFICATION TO REQUEST FOR APPLICATIONS RFA-DE-05-006 RELEASE DATE: February 12, 2004 NOTICE: NOT-DE-04-003 National Institute of Dental and Craniofacial Research (NIDCR) (http://www.nidcr.nih.gov) The following provides clarification to RFA-DE-05-006 (http://grants.nih.gov/grants/guide/rfa-files/RFA-DE-05-006.html) and additional information to prospective applicants related to capitation costs and informatics that should be considered in preparing the budget for the Network Chair application and the Coordinating Center application, respectively: Capitation costs: The Network Chair’s application should present a schedule of 16-22 short-term clinical trials and clinical studies beginning in the second year of support. Funds for each study should be based on a per capita basis for each study and be reported in the Other Expenses category in the budget. These costs should be excluded from the Facilities and Administrative (F&A) cost base. The Checklist Page should include language that indicates that the Study costs are excluded from the F&A base pending specific protocol development and approval. After these factors are known, the NIDCR will make a determination about the reimbursement of F&A costs. Informatics: A critical component associated with the capacity to extend and join clinical research networks is the information technology used to support the General Dental Practice-Based Research Network. Applicants for the Coordinating Center should describe the informatics system underlying their network. Specifically, they should describe the system architecture, software components, and hardware platforms that will comprise the information system. The proposal should include a description of the design methodologies employed to develop the platform and the management strategies associated with maintaining and extending the informatics infrastructure. The proposal should include the system’s use of or inter-operability with the Department of Health and Human Services information standards (see http://www.aspe.hhs.gov/sp/nhii/Standards.html). A strategic goal of the re-engineering of the clinical research enterprise is assessment of the feasibility of joining disparate networks. A discussion of the strategy for opening the information system so that it might interoperate with others should be included in the Coordinating Center application and should include how the system might exploit computer interfaces and/or how the group would codify and communicate information exchange specifications for its system. INQUIRIES We encourage inquiries concerning this Notice and the Request for Applications and welcome the opportunity to answer questions from potential applicants. Please direct inquiries to: Dr. Bruce L. Pihlstrom, Acting Director Division of Population and Health Promotion Sciences NIDCR/National Institutes of Health 45 Center Drive, MSC 6401, Room 4AS43H Bethesda, MD 20892-6401 Tel: 301-594-4830 Fax: 301-480-8322 e-mail: bruce.Pihlstrom@nih.gov


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