Timeline Tables.pdf
PDF 92 KB Posted
- Attached to
- FY24 FDA Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science
- Solicitation number
- FDABAA-24-00123
About this file
This document outlines the application process and timeline for the FY2024 FDA Broad Agency Announcement for Advanced Research and Development of Regulatory Science federal contract opportunity. Applicants can optionally submit early-stage concept papers by November 6, 2023 for preliminary FDA feedback, and required full proposals are due February 20, 2024 for FY2024 funding consideration. The FDA will review concept papers and notify applicants if full proposals should be submitted. Full proposals will be reviewed by subject matter experts, with feedback provided to applicants on unfavorable reviews or requests for revised proposals. The FDA will communicate final award decisions. The solicitation seeks research proposals to advance regulatory science and support the FDA's mission through various defined research areas and sub-areas.
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Other files
| File | Type | Posted |
|---|---|---|
| Table 1.pdf | ||
| FY24 BAA Notice v6.0.pdf | ||
| Word Format Attachments.docx | DOCX document | |
| FY24 BAA Notice v5.0.pdf | ||
| FY24 BAA Notice v4.0.pdf | ||
| BAA Deadlines.pdf | ||
| BAA_FY2023_Awards.pdf | ||
| FY24 BAA Notice v3.0.pdf | ||
| BAA_FY2023_Awards_SAM.pdf | ||
| BAA_FY2023_Awards_SAM.pdf | ||
| Attachment 6 SOW Template.docx | DOCX document | |
| BAA Deadlines.pdf | ||
| Cost Appendix 8 Preaward Survey Accounting System.pdf | ||
| Cost Appendix 7 Proposal Template.xlsx | XLSX spreadsheet | |
| FY24 BAA Notice v2.0.pdf | ||
| BAA Application Overview.pdf |
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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
submission)
Optional Early Concept Paper
Submission
Free standing Concept Paper
(attachment 4)
~Email subject line “Charge
Area_FDABAA- 24-00123
Optional Early Concept Paper” in pdf format
FDA
recommendation for interest or lack of interest of Full Proposal submission
2/20/2024 (Required submission)
Stage I Submittal Packages for FY24 funding consideration
Checklist (attachment 3), Freestanding Concept Paper (attachment 4), $Freestanding Full Proposal (Single email with separate attachments)
~Email subject line “Charge
Area_FDABAA- 24-00123
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
*2/20/2024- 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” in pdf format as a single email with separate attachments.
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 Early Concept Paper with FDA recommendation for Stage One Package submission. Make sure to include BAA number provided in the email subject. Optional Early Concept Paper submission is NOT needed as a qualification step to determine submission of a Stage One Package for FY24 BAA Applications. This submission on or before 11/6/2023 is OPTIONAL.
*Open Period: Stage One Submittal Packages received after February 20, 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
Table 3: Overview of BAA Application Process
Step Process Communication Optional Early Concept Paper
Submission
-Applicants submit Freestanding Concept Paper to FDABAA@fda.hhs.gov -Submissions are optional and due by 11:59 PM (EST), November 6th, 2023.
PDF format only accepted.
-Applicant may choose to follow or not follow FDA’s Submit or Do not Submit recommendation for Stage One Package.
-FDA to notify applicants receipt of documents via email -Notify Submit or Do not Submit recommendation for Stage One Package submission -Clarify information with applicant via email
Submission -Applicants submit Freestanding Concept Paper and Freestanding Full Proposal to FDABAA@fda.hhs.gov -All submissions for FY24 funds consideration due by 11:59 PM (EST), February 20th, 2024 for FY24 funding consideration (includes Stage One Package recommended for Optional Early Concept Paper submissions).
PDF format only accepted.
- FDA to notify applicants receipt of documents via email -Clarify information with applicant via email
Stage I -FDA Program Leaders shall conduct a High-Level review to determine potential program relevance of Freestanding Concept Paper.
-If favorable evaluation of Concept Paper, proceed with Full Proposal Review by Subject Matter Experts as a technical panel, following the evaluation criteria of Part IV.
-If unfavorable evaluation of Concept Paper, Full Proposal will NOT be reviewed, and applicant will be notified of the decision
-FDA to notify applicants unfavorable evaluation of Concept Paper -For favorable Concept Paper evaluations, FDA to request applicants to either submit revised Full Proposal based on the feedback provided by FDA or communicate decision (intent to award or reject) via email -Seek clarifications from
Stage II -Applicants requested to submit a revised Full Proposal to FDABAA@fda.hhs.gov within 30 days of receipt date.
-Revised Full Proposal reviewed by Subject Matter Experts as a technical panel
-Communicate decision (intent to award/reject) via email -Seek clarifications from
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