Login
Login
Register
Complete Your Profile
Change Password
Request a Password Reset
Download Documents
Download Documents
Get Help to Participate in This Tender
HEALTH AND HUMAN SERVICES, DEPARTMENT OF | FOOD AND DRUG ADMINISTRATION has floated a tender for Request for Information: Enterprise Digitization of FDA Submission Records. The project location is USA and the tender is closing on 18 Aug 2025. The tender notice number is 75F40125RFI00099, while the TOT Ref Number is 124469257. Bidders can have further information about the Tender and can request the complete Tender document by Registering on the site.
Procurement Summary
Country: USA
Summary: Request for Information: Enterprise Digitization of FDA Submission Records
Deadline: 18 Aug 2025
Other Information
Notice Type: Tender
TOT Ref.No.: 124469257
Document Ref. No.: 75F40125RFI00099
Financier: Self Financed
Purchaser Ownership: Public
Tender Value: Refer Document
Purchaser's Detail
Name: Login to see tender_details
Address: Login to see tender_details
Email: Login to see tender_details
Login to see detailsTender Details
Description
AMENDMENT #3 (8/13/2025): Part V - Rough Order of Magnitude (ROM) Cost Estimate request added. Due date for responses extended until 12:00pm (Eastern) on Monday, August 18, 2025.
AMENDMENT #2 (8/1/2025): Responses to frequently asked questions have been attached. Due date for responses remains 12:00pm (Eastern) on Friday, August 15, 2025.
AMENDMENT #1 (7/23/2025): Response due date amended to 12:00pm (Eastern) on Friday, August 15, 2025.
The U.S. Food and Drug Administration (FDA), Office of the Commissioner (OC), is conducting market research to gather input from industry regarding digitization of FDA submission records. The purpose of this request is to obtain knowledge about available capabilities and approaches that will help the Agency estimate the scope and cost of digitizing historical paper records and ongoing physical submissions across the Agency.
This Request for Information (RFI), being issued in accordance with Federal Acquisition Regulation (FAR) Part 10, Market Research, is for information, planning, and market research purposes only and does not constitute a commitment, implied or otherwise, that the Department of Health and Human Services (HHS), FDA, or OC will issue a solicitation, award a contract, or otherwise take any other procurement action. This opportunity to respond does not constitute a solicitation for proposals, applications, proposal abstracts, or quotations. The submission of any information is purely voluntary. The Government assumes no financial responsibility for any costs incurred in responding.
The FDA is seeking information from qualified vendors to support a future enterprise-level digitization initiative. This initiative would involve the scanning, processing, and secure handling of physical submission records—both historical (legacy) and ongoing—in support of regulatory review activities.
The goals of this RFI are to:
Understand market capabilities for high-volume, secure digit...
Active Contract Opportunity
Notice ID : 75F40125RFI00099
Related Notice
Department/Ind. Agency : HEALTH AND HUMAN SERVICES, DEPARTMENT OF
Sub-tier : FOOD AND DRUG ADMINISTRATION
Office: FDA OFFICE OF ACQ GRANT SVCS
General Information
Contract Opportunity Type: Special Notice (Updated)
Updated Published Date: Aug 13, 2025 11:09 am EDT
Original Published Date: Jul 23, 2025 10:32 am EDT
Updated Response Date: Aug 18, 2025 12:00 pm EDT
Original Response Date: Aug 25, 2025 10:00 am EDT
Inactive Policy: 15 days after response date
Updated Inactive Date: Sep 02, 2025
Original Inactive Date: Sep 09, 2025
Initiative: None
Classification
Original Set Aside:
Product Service Code:
NAICS Code: 561410 - Document Preparation Services
Place of Performance: Silver Spring, MD USA
Documents
Amend-3_RFI_75F40125RFI00099.pdf
Amend-2_RFI_75F40125RFI00099_FAQs.pdf
Procurement Documents for USA
Access a comprehensive library of standard procurement documents specific to USA. Here, you'll find all the essential forms, guidelines, and templates required for tender applications and submissions in USA
Want To Bid in This Tender?
Get Local Agent Support in USA and 60 More Countries.
View Tenders By
Sign in with Google