SAM #CTP-2027-136871

FDA Regulatory Support Services BPA Market Research

The U.S. Food and Drug Administration is conducting market research for a potential Regulatory Support Services BPA focused on regulatory development, document review, and public-comment operations. - Government buyer: U.S. Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS); the Center for Tobacco Products (CTP) is identified as overseeing implementation of the Family Smoking Prevention and Tobacco Control Act. - Opportunity status: Sources Sought and market research only; no specific products, quantities, OEMs, or vendors are identified. - Services requested: Regulatory-action development and implementation; regulatory document quality, format, and accessibility reviews; Paperwork Reduction Act support; public-comment analysis, database management, and submission processing; project management; and transition-in/transition-out support. - Public-comment work may involve submissions ranging from brief comments to lengthy documents, large write-in campaigns, 500,000 or more comments in a docket, or multiple concurrent dockets. - Submission handling includes electronic and paper comments, FDMS metadata, confidential-information screening, scanning and quality control when needed, and posting as directed. - Notable requirements: Accessible documents meeting Section 508/WCAG requirements; protection of sensitive information; organizational conflict-of-interest management; searchable public-comment data and government read-only access; and support for applicable regulatory processes and laws. - Response requested: Vendor Feedback Form, capability statement, and optional comments on the draft Statement of Work. - Period: One-year base period plus four one-year option periods, with a potential six-month extension. Task-order schedules are to be specified at the order level.

Description

FOOD AND DRUG ADMINISTRATION (FDA)

Regulatory Support Services BPA

SOURCES SOUGHT NOTICE (SSN)

Description

The U.S. Food and Drug Administration's (FDA), Office of Acquisitions and Grants Services (OAGS), is conducting market research for obtaining Regulatory Support Services.

THIS IS A SOURCES SOUGHT NOTICE (SSN) ONLY. This SSN is being issued in accordance with Federal Acquisition Regulation (FAR) Part 10, Market Research. It is for information, planning and market research purposes only and is not to be construed as a commitment by the Government to issue a solicitation or ultimately award a contract. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. The Government reserves the right to contact any of the respondents after the submission deadline if additional information is required.

The purpose of this SSN is to identify and gain knowledge of potential business sources and small business sources that are capable of providing the full range of services described in this SSN and the attached Draft Statement of Work (SOW). Responses to this SSN will be utilized for a potential solicitation for an anticipated stand-alone BPA for Regulatory Support Services Program. The anticipated period of performance for this contract is a Fiscal Year 2027 award with a base year, plus four (4) option years), with a potential 6-month extension of services pursuant to FAR 52.217-8.

Requested Information

Interested parties are highly encouraged to respond to this SSN by providing the following information in their response:

Completed Vendor Feedback Form – See attached Vendor Feedback Form If applicable, tracked changes/comments on draft SOW in MS Word format – See attached Draft SOW Capability Statement

Responses shall be submitted via email with the subject line "Sources Sought Notice - FDA SSN: CTP-2027-136871” to the Contracting Officer, Nicholas Bisher (Nicholas.Bisher@fda.hhs.gov), no later than 5:00pm (Eastern) on November 24, 2026.

Attachments

Vendor Feedback Form Draft Statement of Work

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