Amend 1_RFI_75F40125RFI00099.pdf

75F40125RFI00099

Enterprise Digitization of FDA Submission Records

Request for Information (RFI)

Special Notice Type: Request for Information (RFI)

Title: Enterprise Digitization of FDA Submission Records

Notice ID: 75F40125RFI00099

Federal Organization: U.S. Food and Drug Administration (FDA) / Office of Acquisitions and Grants Services (OAGS)

North American Industry Classification System (NAICS) Code: 561410 (Document Preparation Services)

Product Service Code (PSC): R617 (Support – Administrative: Electronic Records Management Services)

PURPOSE

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.

BACKGROUND

FDA Centers and Offices maintain significant volumes of paper‐based submission records—some of which date back several decades—and continue to receive physical submissions outside of automated digital systems. This RFI aims to assess market readiness, capability, and interest in supporting a comprehensive digitization effort that meets the Agency’s security, technical, and operational requirements.

FDA Centers and Offices currently maintain large volumes of legacy records, as well as receive new paper submissions and non‐Gateway electronic files. These materials are essential for regulatory review but pose challenges for storage, retrieval, and efficient access.

To inform next steps, FDA distributed a standardized data collection template to its Centers and Offices.

Responses provided detailed inventories of paper holdings, operational workflows, reviewer interactions, scanning requirements, and system integration needs. While some components have digitization programs in place, others lack dedicated support and infrastructure.

This RFI reflects consolidated input from across the Agency and is intended to present a unified set of digitization requirements to industry.

SCOPE

Estimated Page Volumes by Center

Across the FDA, the estimated total volume of legacy submission records—including historical paper documents and microfiche materials—exceeds 440 million pages. These records are stored in various formats and physical locations across multiple FDA components and include regulatory submissions, promotional materials, facility diagrams, and other supporting documentation critical to the agency’s regulatory mission.

While the majority of these materials are paper based, it is important to note that approximately 6.3 million pages are stored on microfiche, which may require specialized equipment and processes for digitization.

This estimate reflects the combined holdings of FDA Centers and Offices and is provided to help industry assess the general scale and complexity of a potential agency‐wide digitization effort.

Common Digitization Needs Across FDA

Although digitization workflows vary across the agency, FDA has identified common themes and functional needs, including:

Security and Handling Requirements

Chain‐of‐custody tracking and handling of Confidential Unclassified Information (CUI), Personally Identifiable Information (PII), and Proprietary or trade secret data

Support for onsite digitization where required (e.g., due to document fragility or sensitivity) Secure transport and storage of physical and digital records

Compliance with FDA policies, HHS, and NARA regulations

Document Characteristics

Records include memos, reports, forms, lab notebooks, bound materials, 3D objects, CDs/DVDs, and microfiche Document condition varies; many require flatbed scanning, manual prep, and special handling Most files require searchable PDF (OCR) output with metadata tagging

Digitization Scope

Vendors should demonstrate the ability to:

Remove fasteners and prep fragile materials Perform high‐resolution scanning (minimum 300 dpi) Provide OCR with 99.9% image and metadata accuracy Tag metadata at page, document, or folder level, as applicable Deliver structured outputs (e.g., bookmarked PDFs, searchable archives) Perform quality control (QC) checks and provide reports Return or dispose of physical materials per FDA direction

Volume Management

Ability to scale to support millions of pages annually Support for scan‐on‐demand models Support for ongoing paper and non‐Gateway e‐submissions Fast retrieval and turnaround (e.g., same‐day or within 24 hours)

Integration and Delivery

Capability to integrate with FDA platforms such as Documentum, CBER Connect, eMDR, FDMS, and OCS Connect Adherence to submission file naming conventions and import formatting Secure file transfer and metadata matching

Key Challenges

Handling of fragile, torn, bound, and oversized records (e.g., maps, floor plans) Scanning microfiche with manual intervention Managing non‐paper formats (e.g., audiovisual media, external drives) Supporting Centers with no active digitization support or past reductions in scanning capacity

REQUESTED INFORMATION

Organizations are invited to respond to this RFI by submitting the following information. Responses should be limited to ten (10) pages, excluding cover pages, cover letters, and/or tables of contents.

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 10:00am12:00pm (Eastern) on MondayFriday, August 2515, 2025. Please note: the Contract Specialist will be out of the office without access to email from July 31, 2025 through August 7, 2025 and will respond to emails upon return. The Government reserves the right whether to consider responses submitted after the deadline.

Part I – Respondent Information

1. Organization Name and Address

2. Organization SAM UEI and SAM Registration Expiration Date

3. Organization Primary Point of Contact Name, Title, Email, and Phone Number

4. Organization Primary NAICS Code(s)

5. Organization Socioeconomic Status(es) Under NAICS Code 561410

a. Small Business

b. SBA Certified Small Disadvantaged Business

c. SBA Certified 8(a) Program Participant

d. SBA Certified Alaska Native Corporation (ANC), Indian Tribe, Native Hawaiian

Organization, or Community Development Corporation

e. SBA Certified Historically Underutilized Business Zone (HUBZone) Small Business

f. SBA Certified Service‐Disabled Veteran‐Owned Small Business (SDVOSB)

g. SBA Certified Veteran‐Owned Small Business (VOSB)

h. SBA Certified Economically Disadvantaged Women Owned Small Business (EDWOSB)

i. SBA Certified Women Owned Small Business (WOSB)

j. Other Than Small Business

k. Other

Part II ‐ Capabilities, Methodologies, and Innovative Approaches

The Respondent should describe their organization’s capabilities, methodologies, and innovative approaches to support the digitization of FDA submission records. Responses should reflect an understanding of the background and scope outlined above and address how their organization would approach a large‐scale, secure, and efficient digitization effort across multiple FDA Centers and Offices.

The Respondent should include insights on digitization strategies, operational models (e.g., scan‐on‐ demand, bulk scanning), technology platforms, security protocols, quality assurance measures, and any other relevant solutions that demonstrate their organization’s ability to support this Agency‐wide effort.

Part III – Discovery Phase

As part of this effort, FDA anticipates the need for a Discovery Phase to validate assumptions, refine scope, and inform planning for enterprise‐wide digitization of submission records. Respondents should describe how they would approach this phase to validate scope, assess record types and conditions, and inform pricing and implementation planning. Recommendations are welcomed regarding scanning resolution, handling of fragile or historical documents, and best practices for secure offsite digitization. The goals also include Scope and Pricing Validation (refine per‐page pricing based on material type, condition, and scanning method).

Part IV – Questions & Responses

Please respond to each of the questions below broadly; specificity is not required at this stage. Your responses will help FDA assess industry capabilities and inform planning for a potential future solicitation:

A. Does your organization have proven experience with large‐scale digitization efforts, particularly involving regulatory records, legacy paper files, or other high‐sensitivity documents?

B. What digitization models (e.g., bulk digitization, scan‐on‐demand, onsite vs. offsite) does your organization recommend for an enterprise‐scale, phased approach across varied record types and conditions?

C. How does your organization handle document prep, fragile media, 3D or bound items, and odd‐ sized records (e.g., photographs, charts, engineering plans)?

D. What technologies, platforms, or tools does your organization use to ensure quality, accuracy, OCR, metadata tagging, and secure delivery of digital assets?

E. How does your organization ensure chain‐of‐custody, information security, and compliance with federal records management and privacy standards (e.g., CUI, PII, trade secrets)?

F. What indexing and integration capabilities does your organization offer to ensure records are searchable and accessible to reviewers through government systems?

G. Can your organization accommodate on‐demand digitization requests while simultaneously managing high‐volume backlog digitization projects?

H. Does your organization have experience supporting agencies with existing document room operations or transitioning to fully digital workflows?

I. What recommendations does your organization have to ensure scalability, cost‐effectiveness, and sustainability of a digitization program across multiple FDA Centers and Offices?

DISCLAIMERS AND CONFIDENTIALITY

The Government reserves the right to use information provided by Respondents for any purpose deemed necessary and legally appropriate, including developing future procurement strategies. However, submission of a response does not guarantee inclusion in any resulting solicitation, nor does it obligate the Government to provide feedback or acknowledge receipt. The Government reserves the right to contact any of the Respondents after the submission deadline if additional information is required.

Respondents are encouraged to clearly identify any proprietary or confidential information within their submissions. Such information will be handled in accordance with applicable federal laws and regulations.

The Government reserves the right to use any non‐proprietary information submitted in response to this RFI in the development of future acquisition strategies and related documents.

POINTS OF CONTACT

Contract Specialist:

Noah Wills Noah.Wills@fda.hhs.gov

(240) 402‐5220

Contracting Officer:

James Jenrette James.JenretteIII@fda.hhs.gov

(301) 837‐7549

PROVISIONS

FAR 52.215‐3 Request for Information or Solicitation for Planning Purposes (OCT 1997)

(a) The Government does not intend to award a contract on the basis of this solicitation or to otherwise pay for the information solicited except as an allowable cost under other contracts as provided in subsection 31.205‐18, Bid and proposal costs, of the Federal Acquisition Regulation.

(b) Although "proposal" and "offeror" are used in this Request for Information, your response will be treated as information only. It shall not be used as a proposal.

(c) This solicitation is issued for the purposes identified above.

(End of provision)