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FDA CDER OMSIRA (Over-the-Counter Monograph Safety, Innovation and Reform Act)

Investment ID: 009-000454060

Overview

Program Title
FDA CDER OMSIRA (Over-the-Counter Monograph Safety, Innovation and Reform Act)
Agency
Food and Drug Administration (FDA) [HHS]
Description
To achieve CDERs mission, an integrated approach across the various CDER offices impacted by OMUFA is required to develop new technology capabilities to support user fee management, electronic submissions, industry requests/communications, performance tracking, reporting, and safety. All the technologies that support the CDER Informatics Platform capabilities will need to be leveraged to provide a technology platform to support over-the-counter monograph reviews.
Type of Program
Major IT Investments
Multi-Agency Category
Other

IT Program Budget

Projects

Technology projects under the FDA CDER OMSIRA (Over-the-Counter Monograph Safety, Innovation and Reform Act) program

Supporting IDVs

Example IDV awards for FDA CDER OMSIRA (Over-the-Counter Monograph Safety, Innovation and Reform Act)

Supporting Contracts

Example prime contract awards for FDA CDER OMSIRA (Over-the-Counter Monograph Safety, Innovation and Reform Act)