This Government Contract opportunity from Department Of Health And Human Services was posted on August 15, 2025. The submission period has ended. Browse the details below for market research, or find similar active opportunities.

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Request for Information: Enterprise Digitization of FDA Submission Records

Closed

75F40125RFI00099Federal

Submission Closed08/20/2025, 04:00:00 PM UTC

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

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NAICS: 561410

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Solicitation # FA486127R0001

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POSTED

16 days ago

DEADLINE

in 6 days

General Info

Agency

Department Of Health And Human Services → FDA Office Of Acq Grant Svcs

NAICS

561410 - Document Preparation Services

Place of Performance

Silver Spring, MD, USA

Set-Aside

NONE

Documents

Enterprise Digitization of FDA Submission Records RFI

6 pages · rfi

High

FDA Enterprise Digitization of Submission Records RFI (75F40125RFI00099)

6 pages · rfi

High

75F40125RFI00099 Amendment 4 - Enterprise Digitization of FDA Submission Records FAQs

1 page · q-and-a

Low

75F40125RFI00099 Enterprise Digitization of FDA Submission Records FAQs

q-and-a

Low

Enterprise Digitization of FDA Submission Records RFI

6 pages · rfi

Low

Enterprise Digitization of FDA Submission Records RFI (75F40125RFI00099)

6 pages · rfi

Low

AI Contract Breakdown

Uniform Contract Format

Contract not broken down yet

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Timeline

4 updates

PhaseClosed

PostedJul 23

special-notice

Notice updatedJul 23

Response deadline changed from Aug 25, 2025 to Aug 15, 2025. The notice description changed.

Notice updatedAug 1

The notice description changed.

Notice updatedAug 13

Response deadline changed from Aug 15, 2025 to Aug 18, 2025. The notice description changed.

Notice updatedAug 15

Response deadline changed from Aug 18, 2025 to Aug 20, 2025. The notice description changed.

Response DeadlineAug 20

Deadline has passed

Submission Closed

08/20/2025, 04:00:00 PM UTC

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Organization & Contact Information

AgencyDepartment Of Health And Human Services → FDA Office Of Acq Grant Svcs

Contacts1 person available

OfficeBeltsville, MD, 20705, USA

Organization / AgencyDepartment Of Health And Human Services → FDA Office Of Acq Grant Svcs

Office AddressBeltsville, MD, 20705, USA

Contacts

Noah Wills

contact@example.gov

Full Description

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.