Regulatory Science Extramural Research and Development Projects
Extramural Regulatory Science - BAA
ORES manages FDA-wide programs that provide funding to support extramural regulatory science and innovation to address scientific and public health priorities.
Cutting-Edge Research Funded Through FDA's Advancing Regulatory Science Broad Agency Announcement (BAA)
To spur development and innovation in the field of regulatory science FDA funds extramural research using various contract mechanisms and grants to address high-priority needs within FDA's Regulatory Science Framework:
- Modernize development and evaluation of FDA-regulated products
- Strengthen post-market surveillance and labeling of FDA-regulated products
- Invigorate public health preparedness and response of the FDA, patients, and consumers
Since 2012, FDA has been soliciting proposals to advance the state of the art within these areas through a specialized contract mechanism known as FDA's Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science (Please note that SAM.gov webpage appears with a version log. Please ensure the version in the upper-right corner for the webpage is set to the most recent date). FDA's BAA makes it possible for us to better understand the breath of innovative scientific and technical solutions available in industry, academia, and other government agencies. Proposals selected for award enable FDA to tap into external knowledge, capabilities, and infrastructure to solve complex regulatory science challenges.
Apply for Funding
To apply for Fiscal Year (FY) 2026 funding under the BAA, applicants must submit a freestanding Concept Paper and freestanding Full Proposal in accordance with preparation guidance by February 24, 2026. Early applications are highly encouraged.
Please be informed that Optional Early Concept Paper phase has been removed from the FY26 FDA BAA Announcement posted on SAM.gov (Please note that SAM.gov webpage appears with a version log. Please ensure the version in the upper-right corner for the webpage is set to the most recent date).
Freestanding Concept Papers must describe the proposed research effort in sufficient detail to enable a high-level evaluation of the concept's technical merit and its potential contribution as well as program alignment with FDA priorities and mission. Offerors whose freestanding Concept Paper receives a favorable high-level evaluation will have their Full Proposal evaluated by a panel of subject matter experts (technical evaluation panel).
Learn more information on how to apply for funding under the FY26 BAA see SAM.gov.
| Deadline for submission# | Description | What to submit? | How to Submit? | What to expect? |
|---|---|---|---|---|
| 2/24/2026 (Required submission) | Stage I Submittal Packages for FY26 funding consideration | Checklist, Freestanding Concept Paper ($Freestanding Full Proposal (Single email with separate attachments) | ~Email subject line “Charge Area_FDABAA-26-00123 Concept Paper with Full Proposal” in pdf format. | Evaluate Concept Paper and forward Full Proposal of favorable Concept Papers for review |
| %~Email subject line “BAA Number Concept Paper with Full Proposal” in pdf format (highlight any revised fields of the Concept Paper) | Review Full Proposal | |||
| *2/25/2026 – 9/21/2026 | *Stage I Submittal Packages for open period | *Same as above | *Same as above | *Same as above |
| Within 14 calendar days of FDA request^ | Stage II: Revised Full Proposal Submittal Package | Cover Page, Response summary to feedback, Revised Full Proposal (Single email with separate attachments) | ~Email subject line “BAA Number Revised Full Proposal” in pdf format. Highlight revisions | Review of responses and revised Full Proposal |
Freestanding Full Proposal: Volume I Technical Proposal with appendix (attachment 5) and Volume II Cost Proposal with appendix *Open Period: Stage One Submittal Packages received after February 24, 2026 will still be accepted, but due to a lack of lead time and funding availability may not be considered for award in FY26. These submissions may be considered for award in FY27. ^Unless designated otherwise by the Contracting Officer | ||||
BAA Contract Awards
- FY25 BAA Contracts Awards
- FY24 BAA Contracts Awards
- FY23 BAA Contracts Awards
- FY22 BAA Contracts Awards
- FY21 BAA Contracts Awards
- FY20 BAA Contracts Awards
- FY19 BAA Contracts Awards
- FY18 BAA Contracts Awards
| Fiscal Year | BAA applications Received | No. of Awarded | Total Funds |
|---|---|---|---|
| 2025 | 308 | 15 | $16,737,952.78 |
| 2024 | 278 | 24 | $24,597,676.28 |
| 2023 | 264 | 39 | $26,606,696.92 |
| 2022 | 181 | 45 | $142,495,425.15 |
| 2021 | 192 | 45 | $46,112,948.13 |
| 2020 | 196 | 48 | $55,289,690.12 |
| 2019 | 165 | 53 | $55,266,341.17 |
| 2018 | 159 | 39 | $28,230,765.55 |
| 2017 | 160 | 26 | $29,315,334.25 |
| 2016 | 86 | 29 | $25,272,636.27 |
| 2015 | 92 | 34 | $24,055,857.16 |
| 2014 | 87 | 28 | $20,651,356.81 |
Upcoming Events
- January 20, 2026: FDA Broad Agency Announcement Day - Learn more about the FY 2026 BAA, and how to apply.
Past Events
- November 14, 2024: FDA Broad Agency Announcement Day - Learn more about the FY 2025 BAA, and how to apply.
- January 16, 2024: FY24 FDA Broad Agency Announcement Question and Answer Session will provide an opportunity to the applicants to learn more about the application process and next steps post submission. Join us to learn more about the FY 2024 BAA and clarify any questions on how to apply and/or what to expect after submission?
Resources For You
Contact us: FDABAA@fda.hhs.gov