Amend 4_RFI_75F40125RFI00099_FAQs.pdf

75F40125RFI00099/Amendment 4 – Enterprise Digitization of FDA Submission Records

Frequently Asked Questions

# Frequently Asked Question Response 1 Could you please identify the vendor/contract # that is providing the current service? This is a new requirement with no contractual history.

2 Could you provide a list of Centers and Offices under consideration for this digitization initiative?

Please assume that all FDA centers and offices are under consideration for this digitization initiative.

3 State of the documents. ie: brittle, staples, post-its, paper clips, bound in binders, etc. All the things that would increase or decrease the prep time required for digitization.

The state of the documents includes all types and conditions listed here, including bound materials in binders, stored in cardboard boxes, documents with staples/paper clips/Post-it notes, and mixed media requiring various levels of preparation work. Additionally, the collection includes historical records dating back to 1930’s that are extremely fragile and must be handled with specialized conservation-level care during digitization.

4 Post digitization, what is required for the metadata, doc typing, indexing, number of fields to be indexed, etc. Do you have a list of the FDA/HHS required fields to capture?

The FDA does not maintain a standardized list of required metadata fields, document types, or indexing specifications for post-digitization processes because agency documents encompass various record types with differing requirements, necessitating tailored approaches based on the specific nature and regulatory context of each document category.

5 Does the Program Office have a preference for;

1. complete on-site solutions for the 200+ offices, centers, and laboratories

2. FDA ships direct to one or multiple scan facilities with secure Chain of Custody

3. Utilize local scan centers within a certain radius from the 200+ offices, centers, and laboratories

The FDA does not have a predetermined preference among the three proposed scanning solution approaches (on-site, direct shipping to scan facilities, or local scan centers). The Agency is actively seeking market input and recommendations to inform the decision-making process.

We encourage vendors to provide comprehensive recommendations based on their experience with similar large-scale federal projects, including detailed analysis of advantages, challenges, cost implications, and best practices that address security, chain of custody, operational efficiency, and compliance requirements. The market research responses will be instrumental in helping the Agency determine the optimal approach for this initiative.

6 Are the FDA locations all based in the US (CONUS)? Or can they be offshore as well? For the purpose of the RFI, assume the locations will be based in the United States.

7 Will Part V, Rough Order of Magnitude Cost Estimate, as added in Amendment 3 be excluded from the overall 10 page count limit specified in the RFI? If Part V is included in the main file submission, can the page count be extended to 12 pages?

Yes, the ROM Cost Estimate is excluded from the 10-page limitation, but should be approximately two (2) pages or less.

8 Does the Government expect Part V, Rough Order of Magnitude Cost Estimate, to be included as part of the main work file submission, or should it be submitted in a separate file?

No preference.

9 If a separate file is required for Part V, please confirm the preferred format (e.g., PDF, Word, or Excel)?

No preference.

10 When developing our ROM, what period of performance should Offerors propose to digitize the 440 Million pages? Does FDA expect the project to be 1-year, 5-years, etc.?

No final decisions have been made; therefore, the Respondent may provide information on how long it anticipates the scope of the potential requirement to take.