Request for Information: Enterprise Digitization of FDA Submission Records
Closed Special Notice Posted
- Solicitation number
- 75F40125RFI00099
- Agency
-
FDA Office of Acquisition and Grant Services
Food and Drug Administration, Department of Health and Human Services
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 561410 Document Preparation Services
- Place of performance
- Silver Spring, Maryland, United States
- Points of contact
Notice details come from SAM.gov. Updated .
About this opportunity
The U.S. Food and Drug Administration (FDA), Office of the Commissioner, has issued a Request for Information (RFI) to conduct market research regarding the enterprise digitization of FDA submission records. This Special Notice, designated as RFI 75F40125RFI00099, has undergone four amendments with the most recent extending the response deadline to August 20, 2025, at 12:00 PM Eastern. The FDA is seeking input from qualified vendors to support a future large-scale digitization initiative involving approximately 440 million pages of historical paper records and ongoing physical submissions across the agency's 200+ centers, offices, and laboratories. The initiative would encompass scanning, processing, and secure handling of regulatory submission records, including documents dating back to the 1930s and approximately 6.3 million pages on microfiche. This RFI is purely for market research and planning purposes under Federal Acquisition Regulation Part 10 and does not constitute a commitment to award any future contracts.
The primary objectives of this 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 diverse digitization needs across FDA components. Vendors must submit responses via email to the Contract Specialist Noah Wills, with submissions limited to 10 pages plus a separate 2-page Rough Order of Magnitude cost estimate that was added in Amendment 3. Key requirements include high-resolution scanning capabilities (minimum 300 dpi), 99.9% OCR accuracy, metadata tagging, secure document handling of confidential information, and integration with existing FDA document management platforms. The RFI targets vendors classified under NAICS Code 561410 (Document Preparation Services) and encourages participation from various small business categories, including small disadvantaged, 8(a), HUBZone, veteran-owned, and women-owned businesses. Responses are voluntary, and the government assumes no financial responsibility for costs incurred in preparing submissions.
Notice text
4 versions
Update #4 · Latest ·
AMENDMENT #4 (8/15/2025): Due date for responses extended until 12:00pm (Eastern) on Wednesday, August 20, 2025. Additional responses to frequently asked questions have been attached.
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 digitization.
- Inform acquisition planning and scope estimation for potential future contracts.
- 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.
Responses shall be submitted via email with the subject line “75F40125RFI00099 – Enterprise Digitization of FDA Submission Records” to the Contract Specialist, Noah Wills (Noah.Wills@fda.hhs.gov), no later than 10:00am (Eastern) on Monday, August 25, 2025.
Exact place of performnace is to be determined.
See attached RFI document for full details.
Update #3 ·
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 digitization.
- Inform acquisition planning and scope estimation for potential future contracts.
- 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.
Responses shall be submitted via email with the subject line “75F40125RFI00099 – Enterprise Digitization of FDA Submission Records” to the Contract Specialist, Noah Wills (Noah.Wills@fda.hhs.gov), no later than 10:00am (Eastern) on Monday, August 25, 2025.
Exact place of performnace is to be determined.
See attached RFI document for full details.
Update #2 ·
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 digitization.
- Inform acquisition planning and scope estimation for potential future contracts.
- 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.
Responses shall be submitted via email with the subject line “75F40125RFI00099 – Enterprise Digitization of FDA Submission Records” to the Contract Specialist, Noah Wills (Noah.Wills@fda.hhs.gov), no later than 10:00am (Eastern) on Monday, August 25, 2025.
Exact place of performnace is to be determined.
See attached RFI document for full details.
Update #1 ·
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 digitization.
- Inform acquisition planning and scope estimation for potential future contracts.
- 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.
Responses shall be submitted via email with the subject line “75F40125RFI00099 – Enterprise Digitization of FDA Submission Records” to the Contract Specialist, Noah Wills (Noah.Wills@fda.hhs.gov), no later than 10:00am (Eastern) on Monday, August 25, 2025.
Exact place of performnace is to be determined.
See attached RFI document for full details.
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