On-Site Records Information Management (RIM) IDIQ

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 ([email protected]), and Amanda Edger ([email protected]) 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.