Regulatory Science Extramural Research and Development Projects

Cutting-Edge Research Funded Through FDA's Advancing Regulatory Science Broad Agency Announcement (BAA)

To spur innovation in the field of regulatory science FDA funds extramural research using various contract mechanisms and grants to address broad Agency challenges within FDA's Regulatory Science Framework.

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). FDA's BAA makes it possible for us to solicit innovative ideas and approaches to developing and evaluating FDA-regulated products by tapping into external knowledge and infrastructure in areas where FDA has limited expertise or capacities. The proposals solicited from industry, academia, and other government agencies enable us to better understand the breath of innovative scientific and technical solutions available to solve difficult regulatory science problems.

BAA Announcement Due Dates for FY24 Funding Consideration

FY24 FDA BAA Solicitation:

FY 2024 BAA solicitation version 6 published January 25th, 2024, includes updated information for Stage I package preparation.
Scope added to Charge I, Topic I for Devices and Charge III, Topic F for Drugs (amendments indicated with #)

FY24 FDA BAA Submission:

Please note that the BAA Stage I package is due on February 20, 2024, for FY 2024 funding considerations.
Stage I package* submission: Submissions in PDF format only and email (separate attachments in same email) to FDABAA@fda.hhs.gov with email subject for New submissions as “Charge Area_FDABAA-24-00123 Concept Paper with Full Proposal” and Recommended Submissions as “BAA Number Concept Paper with Full Proposal”.
- *Stage I package submission MUST include:
  - Checklist
  - Freestanding Concept Paper
  - Freestanding Full Proposal- Volume I: Technical Proposal and Volume II: Cost Proposal ( Volume I and II can be submitted as separate files)
- If FDA recommended a Stage I Package Submission (for Optional Early Concept Paper submissions):
  - A revised concept paper may be submitted and the submitted version should highlight any fields that were revised from the version of the Optional Early Concept Paper
  - Provide primary research area and BAA number in concept paper and email
- See Part III: Proposal Preparation and Submission of the FY 2024 BAA solicitation for additional information on Stage One package preparation.

Previous BAA Contract Awards

Upcoming Events

November 14, 2024: FDA Broad Agency Announcement Day - Learn more about the FY 2024 BAA, and how to apply. Advance registration is needed.

Past Events

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?

October 25, 2023: FDA Broad Agency Announcement Day - FDA funds extramural research through an agency-wide Broad Agency Announcement (BAA) for research and development to support regulatory science and innovation. Learn more about the FY 2024 BAA, and how to apply.

Resources For You

Office of Regulatory Science and Innovation