U.S. Food and Drug Administration Regulatory Support Services BPA

Open Pre-Solicitation Posted

Solicitation number
CTP-2027-136871
Agency
Responses due
Set-aside
No set-aside

Opportunity facts

Place of performance
Silver Spring, Maryland, United States

Notice details come from SAM.gov. Updated .

About this opportunity

The Food and Drug Administration's Office of Acquisition and Grant Services (OAGS) is conducting market research ahead of a planned stand-alone Regulatory Support Services blanket purchase agreement (BPA), with responses due November 24, 2026. No set-aside is used. This Sources Sought Notice is for information and planning only and does not commit the Government to issue a solicitation or award a contract. The notice requests a Vendor Feedback Form (Attachment B), a capability statement, and tracked-change comments on the draft Statement of Work in MS Word format. The form asks respondents to confirm capability to provide all services under a small business joint venture or an existing GSA schedule contract, and it asks for GSA schedule coverage for the anticipated five-year period of performance. The anticipated award is in FY 2027, with a base year and four option years, plus a potential six-month extension under FAR 52.217-8. Work is performed primarily at the contractor's facility or telework location, with occasional on-site work at FDA's White Oak campus in Silver Spring, Maryland. The scope covers regulatory document development, quality, format, and accessibility review, Paperwork Reduction Act support, and public comment analysis. Respondents must show experience under the Family Smoking Prevention and Tobacco Control Act and related statutes, and comment analysis experience handling 1-2 sentence to 100-200 page submissions, multiple write-in campaigns, and comments totaling 500,000 or more. Security requirements include FISMA, NIST standards, encryption protocols, incident response procedures, and organizational conflict of interest mitigation. All deliverables must meet Section 508 requirements, and the Government owns all deliverables and products developed under the contract. A kickoff meeting must occur within 14 calendar days of award. The notice lists NAICS 541611 and PSC R499. No incumbent or award value is stated.

Notice text

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:

  1. Completed Vendor Feedback Form – See attached Vendor Feedback Form
  2. If applicable, tracked changes/comments on draft SOW in MS Word format – See attached Draft SOW
  3. 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

  1. Vendor Feedback Form
  2. Draft Statement of Work

Files

File Type Posted
Attachment B - Vendor Feedback Form.docx DOCX document
Attachment A - SOW Regulatory Support Services BPA.docx DOCX document

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