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This document provides submission deadlines and requirements for a Broad Agency Announcement from the Food and Drug Administration for Fiscal Year 2024. Concept papers and full proposals are due on February 19, 2024 and may be submitted for an open period thereafter through September 30, 2024. Optional early concept papers may be submitted by November 6, 2023 for preliminary FDA feedback. Stage I submittals will be evaluated and favorable full proposals advanced for review. Within 30 days of FDA request, finalists must submit a revised full proposal with a response summary and revised proposal. Submissions should be emailed to FDABAA@fda.hhs.gov with the appropriate subject line referencing the charge area, BAA number, concept paper or revised proposal status. The solicitation seeks advanced research and development of regulatory science to support the FDA's public health mission.

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Table 2: Submission deadlines for FY24 BAA

Deadline for submission#

Description What to submit?

How to Submit? What to expect?

11/6/2023 Optional Early Concept Paper

Submission

Free standing Concept Paper

~Email subject line “Charge

Area_ FDABAA- 24-00123

Optional Concept Paper”

FDA

recommendation for interest or lack of interest of Full Proposal submission 2/19/2024 Stage I

Submittal Packages for FY24 funding consideration

Checklist Freestanding Concept Paper Freestanding Full Proposal

~Email subject line “Charge Area_ FDABAA- 24-00123 Concept Paper with Full Proposal”

Evaluate Concept Paper and forward Full Proposal of favorable Concept Papers for review

%~Email subject line “BAA Number_ Concept Paper with Full Proposal”

Review Full Proposal

*2/20/2024- 9/30/2024

*Stage I Submittal Packages for open period

*Same as above

*Same as above *Same as above

Within 30 calendar days of FDA request^

Stage II: Revised Full Proposal Submittal Package

Cover Page, Response summary to feedback, Revised Full Proposal

~Email subject line “BAA Number_Revised Full Proposal”

Review of responses and revised Full Proposal

# All submission deadlines indicate 11:59 PM (Eastern Standard Time) ~FDABAA@fda.hhs.gov $Freestanding Full Proposal: Volume I Technical Proposal with appendix (attachment

5) and Volume II Cost Proposal with appendix %Optional Concept Paper with Full Proposal submission FDA recommendation *Open Period: Stage One Submittal Packages received after February 19, 2024 will still be accepted, but due to a lack of lead time and funding availability may not be considered for award in FY24. These submissions may be considered for award in

FY25.

^Unless designated otherwise by the Contracting Officer mailto:FDABAA@fda.hhs.gov

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