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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