FDA BAA Application Process Overview.pdf
PDF 53 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
About this file
This document is an overview of the application process for the FDA Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science in Fiscal Year 2025.
The key details are:
- The FDA is soliciting basic and applied research and development proposals to support regulatory science and innovation through this BAA.
- Applicants can submit an optional early concept paper by November 8, 2024. Full proposals are due by February 24, 2025.
- The FDA will conduct a high-level review of the concept papers to determine program relevance. Favorable concept papers will proceed to a full proposal review by subject matter experts.
- Applicants with favorably reviewed concept papers may be requested to submit a revised full proposal within 14 days.
- The FDA will communicate decisions (intent to award or reject) to applicants via email and seek clarifications as needed.
View the file
Other files for this federal contract opportunity
| File | Type | Posted |
|---|---|---|
| FY25 BAA Notice V6.pdf | ||
| FY25 BAA Notice V5.pdf | ||
| Timelines for FY25 BAA.docx | DOCX document | |
| 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 | |
| FY25 BAA Notice V4.pdf | ||
| Table 1.docx | DOCX document | |
| Attachment 5.docx | DOCX document | |
| 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 | |
| Attachment 3.docx | DOCX document | |
| Attachment 6 SOW Template.docx | DOCX document |
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Text version
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 8th, 2024. 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 FY25 funds consideration due by 11:59 PM (EST), February 24th, 2025 (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 14 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 mailto:FDABAA@fda.hhs.gov mailto:FDABAA@fda.hhs.gov
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