Timelines for FY25 BAA.docx
DOCX document 23 KB Posted
- Attached to
- FY25 FDA Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science Federal contract opportunity
- Solicitation number
- FDABAA-25-00123
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Other files for this federal contract opportunity
| File | Type | Posted |
|---|---|---|
| FY25 BAA Notice V6.pdf | ||
| FY25 BAA Notice V5.pdf | ||
| Table 1.docx | DOCX document | |
| FY25 BAA Notice V5.pdf | ||
| Attachment 5.docx | DOCX document | |
| Cost Appendix 8 Preaward Survey Accounting System.pdf | ||
| Attachment 4.docx | DOCX document | |
| Table 1.docx | DOCX document | |
| Attachment 5.docx | DOCX document | |
| FY25 BAA Notice V4.pdf | ||
| FY25 BAA Notice V3.pdf | ||
| Table 1.docx | DOCX document | |
| FY25 BAA Notice V2.pdf | ||
| Attachment 5.docx | DOCX document | |
| FY25 BAA Notice V1.pdf | ||
| Attachment 4.docx | DOCX document | |
| Cost Appendix 7 Proposal Template.xlsx | XLSX spreadsheet | |
| FDA BAA Application Process Overview.pdf | ||
| Attachment 6 SOW Template.docx | DOCX document | |
| Attachment 3.docx | DOCX document |
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Text version
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 |
(See attachment 4)
| ~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 |
3/4/2025 (Required submission)
| Stage I Submittal Packages for FY25 funding consideration |
| Checklist (attachment 3), Freestanding Concept Paper (See attachment 4), $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 |
| *3/5/2025-9/20/2025 |
| *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 $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 FY25 BAA Applications. This submission on or before 11/8/2024 is OPTIONAL.
*Open Period: Stage One Submittal Packages received after March 4,2025 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
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