On-Site Records Information Management (RIM) IDIQ

This is not a solicitation announcement. This is a Sources Sought Notice (SSN) only. This SSN is issued solely for market research and planning purposes it does not constitute a Request for Proposal (RFP) or a promise to issue an RFP in the future. Further, the SSN does not commit the Government to contract for any supply or service whatsoever. The FDA is not seeking proposals and will not accept any unsolicited proposals. Responders are advised that the U.S. Government will not pay for any information or administrative costs incurred in response to this SSN; all costs associated with responding to this SSN will be solely at the expense of the interested respondents. Not responding to this SSN does not preclude participation in any future RFP, if issued. The purpose of this sources sought synopsis is to gain knowledge of potential qualified vendors to include potential 8(a) vendors 8(a) relative to the North American Industry Classification System (NAICS) code and capable of providing On-Site Information Records Management.

Responses to this Sources Sought Notice will be used by the Government to make appropriate determinations about potential sources.

Project Title: Records Information Management (RIM) IDIQ

Background/Overview: Over the last quarter century, major shifts in records storage, multimedia management, disclosure requirements, electronic product submission, scientific computing and federally mandated records keeping requirements make it necessary for FDA to move from a paper centric agency to a media neutral information-based organization. This indefinite delivery-indefinite quantity (IDIQ) contract will provide direct support to FDA's move to a broader information-based organization by supporting core functions related to the processing records material that support scientific advancement, public health issues, and the regulatory review process. All FDA Offices and Centers are stakeholders under this IDIQ Vehicle.

The regulatory mission supports many laws and Federal regulations that give FDA its mandate. This includes, but is not limited to, Federal Food, Drug and Cosmetic Act, Food and Drug Administration Safety and Innovation Act (FDASIA), and the following supplementary statutes: Prescription Drug User Fee Act (PDUFA), Generic Drug User Fee Act (GDUFA), Medical Device User Fee Act (MDUFA), Biosimilar User Fee Act (BsUFA), Animal Drug User Fee Act (ADUFA), Animal Generic Drug User Fee Act (AGDUFA), Mammography Quality Standards Act (MQSA), Export Reform and Enhancement Act (EREA), Freedom of Information Act (FOIA), Family Smoking Prevention and Tobacco Control Act (FSPTCA), and Food Safety Modernization Act (FSMA).

Purpose: The FDA is seeking information from experienced sources in On-Site Information Records Management as it is contemplating the establishment of a Indefinite Delivery Indefinite Quantity (IDIQ) to such services. The FDA's primary objective for this effect is to obtain Contractor services related to several records-related activities throughout FDA. Initiatives include on-site records support activities, on-site facility management, and on- site scanning.

Instructions for Responses:

Your responses to the questions provided below will assist the Government in selecting the appropriate acquisition method. Page limit: Maximum 15 pages (font size Times New Roman 11 or larger). A copy of the company capability statement will also be accepted (but not in place of the responses to the below questions). The anticipated period of performance is a 5-year ordering period. After review of the responses received, a pre-solicitation synopsis and formal solicitation may be published on SAM.gov.

Responses to this notice must include company name, address, point of contact, size of business pursuant to the NAICS code, and must respond to the following questions:

1. Is your business a small business under the NAICS code?
2. Is your firm certified under Section 8(a) of the Small Business Act?

Included is a draft Statement of Work that is inclusive of the anticipated Task Areas (Attachment A).

1. All interested parties can provide written opinions on the draft Statement of Work.
2. All opinions expressed should focus on strengthening the draft Statement of Work Tasks to ensure industry understands and comprehends the government's requirements.

Responses to this notice shall be submitted via e-mail to Nicholas Bisher, Contracting Officer (nicholas.bisher@fda.hhs.gov), and Amanda Edger (amanda.edger@fda.hhs.gov) by March 2, 2026 at 2:00 pm. After a review of the received responses, a pre-solicitation synopsis and formal solicitation may be published on SAM.gov.

No solicitation is currently available. This is not a request for proposals and in no way obligates the Government to award any contract. Responses to this Sources Sought Notice will not be considered adequate responses to the solicitation, a request to be added to a prospective offerors list, or a request to receive a copy of the solicitation. Ref. No. FDA-RFI-75F40126Q00061/ALP No. CDER-2026-132281.