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  1. Advancing Regulatory Science

Regulatory Science Extramural Research and Development Projects

FDA Broad Agency Announcement (BAA)


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.


BAA Stage 1 Package Due February 20, 2024



We have received 202 complete optional early concept papers that were submitted on time. All recommendations (Submit or Do Not Submit) have been communicated to applicants that have submitted on-time and completed optional early concept papers. Reason for Do Not Submit recommendation was predominantly lack of alignment with FDA's program priorities. Please refer the Charges and Topics in Regulatory Science Framework.

If you have submitted a completed optional early concept paper and not received any follow-up communication from FDA regarding a recommendation, please contact FDABAA@fda.hhs.gov.

Charge/Topic  Received Submit Do Not Submit
Total 202  86 116
Charge I Modernize development and evaluation of FDA-regulated products 145  60 85
A. Alternative Methods 12 3 9
B. Advanced Manufacturing Approaches 59  17 42
C. Analytical and Computational Methods 34 18 16
D. Biomarkers 8 2 6
E. Clinical Outcome Assessment 3 2 1
F. Complex and Novel Clinical Trial Design 9 4 5
G. Predictive Toxicology 1 1 0
H. Methods for Assessing Behavioral, Economic, or Human Factors 4 2 2
I. Approaches to Incorporate Patient and Consumer Input 1 1 0
J. Methods to Assess Real-World Data to serve as Real-World Evidence 12  9 3
K. Methods to Assess Data Source Interoperability 2 1 1
Charge II Strengthen post-market surveillance and labeling of FDA-regulated products 22 11 11
A. Methods to Assess Real-World Data to Support Regulatory Decision-Making 7 6 1
B. Using and Validating Artificial Intelligence Approaches 5 2 3
C. Novel Clinical Trial Design, Statistical and Epidemiologic Methods 1 0 1
D. Automated Reporting Tools for Adverse Events and Active Surveillance 4 0 4
E. Methods to Improve Communication About Risk to Patients and Consumers 1 0 1
F. Approach to Expand Data Capacity, and Increase Data Quality and Usen 2 2 0
G. Efforts to Harmonize Existing and Emerging Data Standards 2 1 1
Charge III Invigorate public health preparedness and response of the FDA, patients, and consumers 35 15 20
A. Reinforce Medical Countermeasures Initiative (MCMi) 13 3 10
B. Antimicrobial Resistance 8 2 6
C. Patient and Consumer Engagement 3 1 2
D. Substance Use and Misuse 7 6 1
E. One Health Approaches 1 1 0
F. Global Product Safety net 3 2 1
G. Emerging Technologies 0 0 0


Previous BAA Contract Awards

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. 

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