FY24 FDA Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science

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. Join us to learn more about the FY 2024 BAA, and how to apply. Save the date for the 2023 FDA Broad Agency Announcement (BAA) Day!

October 25, 2023. BAA Day for FY23 2024 will be hosted on October 25th, 2023, as a virtual only event and will provide an opportunity to learn more about the application process and FDA’s priorities for regulatory research. https://www.fda.gov/science-research/2023-fda-broad-agency-announcement-day-10252023 Amendment 01 - Updated to include the list of FY23 BAA Awards Amendment 02 - FY23 award info updated, Submission due date updated, BAA instructions updated to Version 3, Version 2 deleted. BAA Deadlines document Updated to remove non-functioning Hyperlinks. Inserting Optional Concept Paper clarification Here:

OPTIONAL Early Concept Paper Submission and Review: Applicants may also submit a freestanding Concept Paper by 11:59 PM (Eastern Standard Time) on November 6th, 2023. 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 will receive a favorable high-level evaluation will be recommended for Stage One Package submission.

Offerors receiving a recommendation to submit a Stage One Package may submit a Checklist (See attachment 3), freestanding Concept Paper (same as Optional Early Concept Paper or revised version) along with a freestanding Full Proposal on or before February 19th, 2024 for FY24 funding consideration.

Offerors that do not receive a recommendation for Stage One Package submission may still consider submitting a revised or new freestanding Concept Paper along with a freestanding Full Proposal on or before February 19th, 2024 for FY24 funding consideration. Please note that the submission of Optional Early Concept Paper is OPTIONAL. The offeror can choose to follow or not follow FDA’s recommendation for Stage One Package Submission.

Optional Early Concept Paper submission is NOT needed as a qualification step for consideration of a Stage One Package for FY24 BAA Applications. Inserting link to the BAA recording and materials here: https://www.fda.gov/science-research/advancing-regulatory-science/2023-fda-broad-agency-announcement-day-10252023 (Copy and paste)

Amendment 03 - Updated the BAA Notice to Version 4.0. Notable changes include:

Added highlight for emphisis to the sentence - Please note that FDA is not obligated to provide feedback for Optional Early Concept paper after high-level review.

Stage 1: Submission of a freestanding Concept Paper and freestanding Full Proposal in accordance with the preparation guidance in Section 2 of Part III – see Table 2 for detailed timelines. Freestanding Concept Papers shall describe the 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.

Evaluation of Concept Papers will be conducted by scientific experts leading the various FDA Research Priorities (Table 1). Offerors whose freestanding Concept Paper did not receive a favorable evaluation will be notified by email regarding the outcome of high-level evaluation. Offerors whose freestanding Concept Paper will receive a favorable high-level evaluation will be forwarded on for an evaluation of a Full Proposal.

Full Proposal will follow a scientific review process described in Part IV and will be evaluated by a panel of subject matter experts (technical evaluation panel). FEEDBACK COMMENTS will only be provided if the submission goes to SME review and is not selected for award. Applications. Please note that FDA is not obligated to provide feedback for Optional Early Concept paper after high-level review.

Announcement of the FY24 FDA Broad Agency Announcement Question and Answer Session. this link for the description and to register can be found here: https://www.fda.gov/science-research/advancing-regulatory-science/fy24-fda-broad-agency-announcement-question-and-answer-session-01162024 Amendment 4: Updated BAA document.

Amendment 5: Updated BAA document.