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  1. Advancing Regulatory Science

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.

FDA Broad Agency Announcement (BAA)

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:

  1. Modernize development and evaluation of FDA-regulated products
  2. Strengthen post-market surveillance and labeling of FDA-regulated products
  3. 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. 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) 2025 funding under the BAA, applicants must submit a freestanding Concept Paper and freestanding Full Proposal in accordance with preparation guidance by February 24, 2025.

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).

Applicants may also submit an optional freestanding early Concept Paper by 11:59 p.m. (EST) on November 8, 2024. Any Concept Paper received by this date will undergo a high-level evaluation for program alignment with FDA priorities and mission. Offerors whose freestanding Concept Paper receive a favorable high-level evaluation will be recommended for Stage One Package submission.

Learn more information on how to apply for funding under the FY25 BAA see SAM.gov.

Upcoming Events

January 16, 2025: FY25 FDA Broad Agency Announcement Question and Answer Session - Learn more about the FY 2025 BAA, and how to apply. Advance registration is needed.

Deadline for submission# Description What to submit? How to Submit? What to expect?
11/8/2024 (OPTIONAL submission) Optional Early Concept Paper Submission Free standing Concept Paper ~Email subject line “Charge Area_FDABAA-25-00123 Optional Early Concept Paper” in pdf format FDA recommendation for interest or lack of interest of Full Proposal submission
2/24/2025 (Required submission) Stage I Submittal Packages for FY25 funding consideration Checklist, Freestanding Concept Paper ($Freestanding Full Proposal (Single email with separate attachments) ~Email subject line “Charge Area_FDABAA-25-00123 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
*2/25/2025-9/20/2025 *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
# All submission deadlines indicate 11:59 PM (Eastern Standard Time)
~FDABAA@fda.hhs.gov
$Refer to FY25 BAA announcement for details
%Optional Early Concept Paper submission is NOT needed as a qualification step to determine submission of a Stage One Package for FY25 BAA Applications. This submission on or before 11/8/2024 is OPTIONAL.
*Open Period: Stage One Submittal Packages received after February 24, 2025 will still be accepted, but due to a lack of lead time and funding availability may not be considered for award in FY25. These submissions may be considered for award in FY26.
^Unless designated otherwise by the Contracting Officer

BAA Contract Awards

Past Events

Resources For You

Contact us: FDABAA@fda.hhs.gov

 

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