BAA Application Overview.pdf
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- 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 provides an overview of the application process for the FY24 FDA Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science solicitation. The BAA solicits concept papers and full proposals for funding consideration, with submission deadlines of November 6th, 2023 for optional concept papers and February 19th, 2024 for full proposals. A two-stage review process is outlined. In Stage I, concept papers will receive a high-level review and feedback to determine relevance before full proposals are reviewed. In Stage II, applicants may submit revised full proposals within 30 days of feedback receipt for further review. The Food and Drug Administration will notify applicants of funding decisions and seek clarifications as needed via email. The solicitation seeks to advance regulatory science research within the FDA's areas of responsibility.
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Other files
| File | Type | Posted |
|---|---|---|
| Table 1.pdf | ||
| FY24 BAA Notice v6.0.pdf | ||
| Word Format Attachments.docx | DOCX document | |
| Timeline Tables.pdf | ||
| 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 |
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Text version
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 -All submissions due by 11:59 PM (EST), November 6th, 2023
-FDA to notify applicants receipt of documents via email -Notify recommendation for interest or lack of interest for Full Proposal 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 19th, 2024 for FY24 funding consideration (includes Full Proposal recommended for optional, early Concept Paper submissions)
- 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 following the evaluation criteria -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 provides 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
-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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