Request for Information: Enterprise Digitization of FDA Submission Records
Title:  

Request for Information: Enterprise Digitization of FDA Submission Records

Agency:  

U.S. Department Of Health And Human Services

State:  

Maryland

NAICS Code:  

561410

Industry:  

Information Technology and Software Development

Solicitation Type:  

Request for Information

Solicitation ID:  

75F40125RFI00099

Open Date:  

7/23/2025

Close Date:  

8/15/2025

Last Updated:  

8/2/2025

Description:
The U.S. Food and Drug Administration (FDA) is conducting market research to gather input from industry regarding the digitization of FDA submission records. The goals of this Request for Information (RFI) are to understand market capabilities for high-volume, secure digitization, inform acquisition planning and scope estimation for potential future contracts, and assess vendor readiness to manage the diverse and complex digitization needs across FDA components. The information gathered will help FDA plan for a unified approach to digitization that enhances reviewer access to regulatory information, ensures secure handling of sensitive data, and reduces the long-term costs of maintaining paper-based archives. Key aspects of the job include: • Scanning, processing, and secure handling of physical submission records • Managing diverse and complex digitization needs across FDA components • Ensuring secure handling of sensitive data • Reducing the long-term costs of maintaining paper-based archives • Enhancing reviewer access to regulatory information
Attached Files:

Please visit the bid source via the “Link to Bid Source” button below for documentation.

Contact Information:

Noah Wills(Contract Specialist)

Noah.Wills@fda.hhs.gov

Budget Estimate (AI):

$500,000 – $5,000,000

The budget for this opportunity is difficult to estimate, as it is a Request for Information and not a solicitation for a contract. However, based on the scope of the project, which involves the digitization of historical and ongoing physical submission records, the cost could be substantial. Factors that may influence the likely payment range include the volume of records to be digitized, the level of security required, and the complexity of the digitization process. A rough estimate could be in the range of $500,000 to $5 million, depending on the scope and complexity of the project.

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