January 6, 2021
RFA-FD-21-013 - Physiologically-based pharmacokinetic (PBPK) models to aid the development of generic dermatological products (U01) Clinical Trials Optional
U.S. Food and Drug Administration (FDA)
The purpose of this Notice is to update language regarding the data sharing plan requirements in Section I. Funding Opportunity Description
NOTE: The expectation is that the data generated as an outcome of this research award, including but not necessarily limited to any individual replicate/subject-level data (not just summary results), any model constructs/code and data sets that represent an outcome of the award will be shared with the FDA Office of Generic Drugs (OGD) prior to the completion of the award period. The applicant's Data Sharing Plan will specifically be considered during the review process of the submitted proposal.
All other aspects of this FOA remain unchanged.
Grants Management Specialist
Office of Operations, Office of Finance Budget & Acquisitions
Office of Acquisitions and Grant Services, HFA-500
U.S. Food and Drug Administration