Request for Information: Enterprise Digitization of FDA Submission Records 75F40125RFI00099

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.

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.

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.

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.