NOT-FD-21-002: Notice to Update Data Sharing Plan in Section I - Development of Methods to Evaluate the Impact of Design Differences to the User Interface of Generic Drug-Device Combination Products in Comparison to their Reference Listed Drugs

Notice to Update Data Sharing Plan in Section I - Development of Methods to Evaluate the Impact of Design Differences to the User Interface of Generic Drug-Device Combination Products in Comparison to their Reference Listed Drugs

Notice Number:

NOT-FD-21-002

Key Dates

Release Date:

January 6, 2021

Related Announcements

RFA-FD-21-014 - Development of Methods to Evaluate the Impact of Design Differences to the User Interface of Generic Drug-Device Combination Products in Comparison to their Reference Listed Drugs (U01) Clinical Trials Optional

Issued by

U.S. Food and Drug Administration (FDA)

Purpose

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.

Inquiries

Please direct all inquiries to:

Shashi Malhotra

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

Tel: 301-402-7592

[email protected]