FY26 FDA Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science

SOL #: FDABAA-26-00123Special Notice

Overview

Buyer

Health And Human Services
Food And Drug Administration
FDA Office of Acquisitions and Grants Services
Rockville, MD, 20857, United States

Place of Performance

Silver Spring, MD

NAICS

Research and Development in Biotechnology (except Nanobiotechnology) (541714)

PSC

General Science And Technology R&D Services; General Science And Technology; Basic Research (AJ11)

Set Aside

No set aside specified

Timeline

1
Posted
Nov 21, 2025
2
Last Updated
Jan 16, 2026
3
Action Date
Feb 25, 2026, 4:59 AM

Qualification Details

Fit reasons
  • NAICS alignment with historical contract wins in similar service areas.
  • Scope strongly matches core technical capabilities and delivery model.
Risks
  • Past performance thresholds may require one additional teaming partner.
  • Potential clarification needed on staffing minimums before bid/no-bid.
Next steps

Validate eligibility requirements, assign capture owner, and schedule partner outreach to confirm teaming strategy before submission planning.

In accordance with FAR 6.102(d)(2) and 35.016, the US Food and Drug Administration (FDA) solicits for the acquisition of basic and applied research and development proposals to support regulatory science and innovation through this Broad Agency Announcement (BAA). Research and development activities acquired under this BAA are intended to advance scientific knowledge in specific research areas as well as sub areas of interest defined within the BAA that serve the FDA in accomplishing its mission to protect and promote the health of our nation. Proposals submitted under this announcement are not limited solely to the PSC code "AJ11" specified in this announcement. 

FDA funds extramural research through an agency-wide Broad Agency Announcement (BAA) for research and development to support regulatory science and innovation. 

People

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Versions

Version 4
Special Notice
Posted: Jan 16, 2026
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Version 3
Special Notice
Posted: Jan 6, 2026
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Version 2
Special Notice
Posted: Dec 16, 2025
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Version 1Viewing
Special Notice
Posted: Nov 21, 2025