FY24 FDA Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science
Closed Pre-Solicitation Posted
Not the latest version. See the latest special notice from .
- Solicitation number
- FDABAA-24-00123
- Agency
-
FDA Office of Acquisition and Grant Services
Food and Drug Administration, Department of Health and Human Services
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 541714 Research and Development in Biotechnology (except Nanobiotechnology)
- PSC
- AJ11 General Science And Technology R&D Services; General Science And Technology; Basic Research
- Place of performance
- Silver Spring, Maryland 20993, United States
Notice details come from SAM.gov. Updated .
About this opportunity
This Broad Agency Announcement from the Food and Drug Administration solicits advanced research and development proposals to support regulatory science across three priority areas: modernizing product development and evaluation; strengthening post-market surveillance and labeling; and enhancing public health preparedness and response. Proposals are requested for over 30 defined research focus areas and must address at least one priority area. A two-stage review process involves an initial concept paper due November 6, 2023 and full proposal due February 19, 2024. Multiple awards are expected based on proposal quality and relevance to FDA's regulatory science mission and objectives.
No set-aside is designated for this opportunity. The primary NAICS code is 541715 and PSC code AJ11. Based on past awards under similar Broad Agency Announcements, major academic institutions and non-profits such as Stanford University, Johns Hopkins University, and Battelle Memorial Institute are likely to compete. Previous solicitations have resulted in over 75 awards totaling more than $26 million over multiple years, indicating the potential value of individual awards under this announcement may range from several hundred thousand dollars for focused studies up to over $4 million for large, long-term research programs.
Notice text
6 versions
Update #6 · Latest ·
In accordance with FAR 6.102(d)(2) and 35.016, the US Food and Drug Administration (FDA) solicits for the acquisition of basic and applied research and development proposals to support regulatory science and innovation through this Broad Agency Announcement (BAA). Research and development activities acquired under this BAA are intended to advance scientific knowledge in specific research areas as well as sub areas of interest defined within the BAA that serve the FDA in accomplishing its mission to protect and promote the health of our nation. Proposals submitted under this announcement are not limited solely to the PSC code "AJ11" specified in this announcement.
FDA funds extramural research through an agency-wide Broad Agency Announcement (BAA) for research and development to support regulatory science and innovation. Join us to learn more about the FY 2024 BAA, and how to apply.
Save the date for the 2023 FDA Broad Agency Announcement (BAA) Day! October 25, 2023. BAA Day for FY23 2024 will be hosted on October 25th, 2023, as a virtual only event and will provide an opportunity to learn more about the application process and FDA’s priorities for regulatory research.
https://www.fda.gov/science-research/2023-fda-broad-agency-announcement-day-10252023
Amendment 01 - Updated to include the list of FY23 BAA Awards
Amendment 02 - FY23 award info updated, Submission due date updated, BAA instructions updated to Version 3, Version 2 deleted. BAA Deadlines document Updated to remove non-functioning Hyperlinks. Inserting Optional Concept Paper clarification Here:
OPTIONAL Early Concept Paper Submission and Review: Applicants may also submit a freestanding Concept Paper by 11:59 PM (Eastern Standard Time) on November 6th, 2023. Any Concept Paper received by this date will undergo a high-level evaluation for program alignment with FDA priorities and mission. Offerors whose freestanding Concept Paper will receive a favorable high-level evaluation will be recommended for Stage One Package submission. Offerors receiving a recommendation to submit a Stage One Package may submit a Checklist (See attachment 3), freestanding Concept Paper (same as Optional Early Concept Paper or revised version) along with a freestanding Full Proposal on or before February 19th, 2024 for FY24 funding consideration. Offerors that do not receive a recommendation for Stage One Package submission may still consider submitting a revised or new freestanding Concept Paper along with a freestanding Full Proposal on or before February 19th, 2024 for FY24 funding consideration. Please note that the submission of Optional Early Concept Paper is OPTIONAL. The offeror can choose to follow or not follow FDA’s recommendation for Stage One Package Submission. Optional Early Concept Paper submission is NOT needed as a qualification step for consideration of a Stage One Package for FY24 BAA Applications.
Inserting link to the BAA recording and materials here:
https://www.fda.gov/science-research/advancing-regulatory-science/2023-fda-broad-agency-announcement-day-10252023 (Copy and paste)
Amendment 03 - Updated the BAA Notice to Version 4.0. Notable changes include:
Added highlight for emphisis to the sentence - Please note that FDA is not obligated to provide feedback for Optional Early Concept paper after high-level review.
Stage 1: Submission of a freestanding Concept Paper and freestanding Full Proposal in accordance with the preparation guidance in Section 2 of Part III – see Table 2 for detailed timelines. Freestanding Concept Papers shall describe the effort in sufficient detail to enable a high-level evaluation of the concept's technical merit and its potential contribution as well as program alignment with FDA priorities and mission. Evaluation of Concept Papers will be conducted by scientific experts leading the various FDA Research Priorities (Table 1). Offerors whose freestanding Concept Paper did not receive a favorable evaluation will be notified by email regarding the outcome of high-level evaluation. Offerors whose freestanding Concept Paper will receive a favorable high-level evaluation will be forwarded on for an evaluation of a Full Proposal. Full Proposal will follow a scientific review process described in Part IV and will be evaluated by a panel of subject matter experts (technical evaluation panel). FEEDBACK COMMENTS will only be provided if the submission goes to SME review and is not selected for award.
Applications. Please note that FDA is not obligated to provide feedback for Optional Early Concept paper after high-level review.
Announcement of the FY24 FDA Broad Agency Announcement Question and Answer Session. this link for the description and to register can be found here: https://www.fda.gov/science-research/advancing-regulatory-science/fy24-fda-broad-agency-announcement-question-and-answer-session-01162024
Amendment 4: Updated BAA document.
Amendment 5: Updated BAA document.
Update #5 ·
In accordance with FAR 6.102(d)(2) and 35.016, the US Food and Drug Administration (FDA) solicits for the acquisition of basic and applied research and development proposals to support regulatory science and innovation through this Broad Agency Announcement (BAA). Research and development activities acquired under this BAA are intended to advance scientific knowledge in specific research areas as well as sub areas of interest defined within the BAA that serve the FDA in accomplishing its mission to protect and promote the health of our nation. Proposals submitted under this announcement are not limited solely to the PSC code "AJ11" specified in this announcement.
FDA funds extramural research through an agency-wide Broad Agency Announcement (BAA) for research and development to support regulatory science and innovation. Join us to learn more about the FY 2024 BAA, and how to apply.
Save the date for the 2023 FDA Broad Agency Announcement (BAA) Day! October 25, 2023. BAA Day for FY23 2024 will be hosted on October 25th, 2023, as a virtual only event and will provide an opportunity to learn more about the application process and FDA’s priorities for regulatory research.
https://www.fda.gov/science-research/2023-fda-broad-agency-announcement-day-10252023
Amendment 01 - Updated to include the list of FY23 BAA Awards
Amendment 02 - FY23 award info updated, Submission due date updated, BAA instructions updated to Version 3, Version 2 deleted. BAA Deadlines document Updated to remove non-functioning Hyperlinks. Inserting Optional Concept Paper clarification Here:
OPTIONAL Early Concept Paper Submission and Review: Applicants may also submit a freestanding Concept Paper by 11:59 PM (Eastern Standard Time) on November 6th, 2023. Any Concept Paper received by this date will undergo a high-level evaluation for program alignment with FDA priorities and mission. Offerors whose freestanding Concept Paper will receive a favorable high-level evaluation will be recommended for Stage One Package submission. Offerors receiving a recommendation to submit a Stage One Package may submit a Checklist (See attachment 3), freestanding Concept Paper (same as Optional Early Concept Paper or revised version) along with a freestanding Full Proposal on or before February 19th, 2024 for FY24 funding consideration. Offerors that do not receive a recommendation for Stage One Package submission may still consider submitting a revised or new freestanding Concept Paper along with a freestanding Full Proposal on or before February 19th, 2024 for FY24 funding consideration. Please note that the submission of Optional Early Concept Paper is OPTIONAL. The offeror can choose to follow or not follow FDA’s recommendation for Stage One Package Submission. Optional Early Concept Paper submission is NOT needed as a qualification step for consideration of a Stage One Package for FY24 BAA Applications.
Inserting link to the BAA recording and materials here:
https://www.fda.gov/science-research/advancing-regulatory-science/2023-fda-broad-agency-announcement-day-10252023 (Copy and paste)
Amendment 03 - Updated the BAA Notice to Version 4.0. Notable changes include:
Added highlight for emphisis to the sentence - Please note that FDA is not obligated to provide feedback for Optional Early Concept paper after high-level review.
Stage 1: Submission of a freestanding Concept Paper and freestanding Full Proposal in accordance with the preparation guidance in Section 2 of Part III – see Table 2 for detailed timelines. Freestanding Concept Papers shall describe the effort in sufficient detail to enable a high-level evaluation of the concept's technical merit and its potential contribution as well as program alignment with FDA priorities and mission. Evaluation of Concept Papers will be conducted by scientific experts leading the various FDA Research Priorities (Table 1). Offerors whose freestanding Concept Paper did not receive a favorable evaluation will be notified by email regarding the outcome of high-level evaluation. Offerors whose freestanding Concept Paper will receive a favorable high-level evaluation will be forwarded on for an evaluation of a Full Proposal. Full Proposal will follow a scientific review process described in Part IV and will be evaluated by a panel of subject matter experts (technical evaluation panel). FEEDBACK COMMENTS will only be provided if the submission goes to SME review and is not selected for award.
Applications. Please note that FDA is not obligated to provide feedback for Optional Early Concept paper after high-level review.
Announcement of the FY24 FDA Broad Agency Announcement Question and Answer Session. this link for the description and to register can be found here: https://www.fda.gov/science-research/advancing-regulatory-science/fy24-fda-broad-agency-announcement-question-and-answer-session-01162024
Amendment 4: Updated BAA document.
Update #4 ·
In accordance with FAR 6.102(d)(2) and 35.016, the US Food and Drug Administration (FDA) solicits for the acquisition of basic and applied research and development proposals to support regulatory science and innovation through this Broad Agency Announcement (BAA). Research and development activities acquired under this BAA are intended to advance scientific knowledge in specific research areas as well as sub areas of interest defined within the BAA that serve the FDA in accomplishing its mission to protect and promote the health of our nation. Proposals submitted under this announcement are not limited solely to the PSC code "AJ11" specified in this announcement.
FDA funds extramural research through an agency-wide Broad Agency Announcement (BAA) for research and development to support regulatory science and innovation. Join us to learn more about the FY 2024 BAA, and how to apply.
Save the date for the 2023 FDA Broad Agency Announcement (BAA) Day! October 25, 2023. BAA Day for FY23 2024 will be hosted on October 25th, 2023, as a virtual only event and will provide an opportunity to learn more about the application process and FDA’s priorities for regulatory research.
https://www.fda.gov/science-research/2023-fda-broad-agency-announcement-day-10252023
Amendment 01 - Updated to include the list of FY23 BAA Awards
Amendment 02 - FY23 award info updated, Submission due date updated, BAA instructions updated to Version 3, Version 2 deleted. BAA Deadlines document Updated to remove non-functioning Hyperlinks. Inserting Optional Concept Paper clarification Here:
OPTIONAL Early Concept Paper Submission and Review: Applicants may also submit a freestanding Concept Paper by 11:59 PM (Eastern Standard Time) on November 6th, 2023. Any Concept Paper received by this date will undergo a high-level evaluation for program alignment with FDA priorities and mission. Offerors whose freestanding Concept Paper will receive a favorable high-level evaluation will be recommended for Stage One Package submission. Offerors receiving a recommendation to submit a Stage One Package may submit a Checklist (See attachment 3), freestanding Concept Paper (same as Optional Early Concept Paper or revised version) along with a freestanding Full Proposal on or before February 19th, 2024 for FY24 funding consideration. Offerors that do not receive a recommendation for Stage One Package submission may still consider submitting a revised or new freestanding Concept Paper along with a freestanding Full Proposal on or before February 19th, 2024 for FY24 funding consideration. Please note that the submission of Optional Early Concept Paper is OPTIONAL. The offeror can choose to follow or not follow FDA’s recommendation for Stage One Package Submission. Optional Early Concept Paper submission is NOT needed as a qualification step for consideration of a Stage One Package for FY24 BAA Applications.
Inserting link to the BAA recording and materials here:
https://www.fda.gov/science-research/advancing-regulatory-science/2023-fda-broad-agency-announcement-day-10252023 (Copy and paste)
Amendment 03 - Updated the BAA Notice to Version 4.0. Notable changes include:
Added highlight for emphisis to the sentence - Please note that FDA is not obligated to provide feedback for Optional Early Concept paper after high-level review.
Stage 1: Submission of a freestanding Concept Paper and freestanding Full Proposal in accordance with the preparation guidance in Section 2 of Part III – see Table 2 for detailed timelines. Freestanding Concept Papers shall describe the effort in sufficient detail to enable a high-level evaluation of the concept's technical merit and its potential contribution as well as program alignment with FDA priorities and mission. Evaluation of Concept Papers will be conducted by scientific experts leading the various FDA Research Priorities (Table 1). Offerors whose freestanding Concept Paper did not receive a favorable evaluation will be notified by email regarding the outcome of high-level evaluation. Offerors whose freestanding Concept Paper will receive a favorable high-level evaluation will be forwarded on for an evaluation of a Full Proposal. Full Proposal will follow a scientific review process described in Part IV and will be evaluated by a panel of subject matter experts (technical evaluation panel). FEEDBACK COMMENTS will only be provided if the submission goes to SME review and is not selected for award.
Applications. Please note that FDA is not obligated to provide feedback for Optional Early Concept paper after high-level review.
Announcement of the FY24 FDA Broad Agency Announcement Question and Answer Session. this link for the description and to register can be found here: https://www.fda.gov/science-research/advancing-regulatory-science/fy24-fda-broad-agency-announcement-question-and-answer-session-01162024
Update #3 ·
In accordance with FAR 6.102(d)(2) and 35.016, the US Food and Drug Administration (FDA) solicits for the acquisition of basic and applied research and development proposals to support regulatory science and innovation through this Broad Agency Announcement (BAA). Research and development activities acquired under this BAA are intended to advance scientific knowledge in specific research areas as well as sub areas of interest defined within the BAA that serve the FDA in accomplishing its mission to protect and promote the health of our nation. Proposals submitted under this announcement are not limited solely to the PSC code "AJ11" specified in this announcement.
FDA funds extramural research through an agency-wide Broad Agency Announcement (BAA) for research and development to support regulatory science and innovation. Join us to learn more about the FY 2024 BAA, and how to apply.
Save the date for the 2023 FDA Broad Agency Announcement (BAA) Day! October 25, 2023. BAA Day for FY23 2024 will be hosted on October 25th, 2023, as a virtual only event and will provide an opportunity to learn more about the application process and FDA’s priorities for regulatory research.
https://www.fda.gov/science-research/2023-fda-broad-agency-announcement-day-10252023
Amendment 01 - Updated to include the list of FY23 BAA Awards
Amendment 02 - FY23 award info updated, Submission due date updated, BAA instructions updated to Version 3, Version 2 deleted. BAA Deadlines document Updated to remove non-functioning Hyperlinks. Inserting Optional Concept Paper clarification Here:
OPTIONAL Early Concept Paper Submission and Review: Applicants may also submit a freestanding Concept Paper by 11:59 PM (Eastern Standard Time) on November 6th, 2023. Any Concept Paper received by this date will undergo a high-level evaluation for program alignment with FDA priorities and mission. Offerors whose freestanding Concept Paper will receive a favorable high-level evaluation will be recommended for Stage One Package submission. Offerors receiving a recommendation to submit a Stage One Package may submit a Checklist (See attachment 3), freestanding Concept Paper (same as Optional Early Concept Paper or revised version) along with a freestanding Full Proposal on or before February 19th, 2024 for FY24 funding consideration. Offerors that do not receive a recommendation for Stage One Package submission may still consider submitting a revised or new freestanding Concept Paper along with a freestanding Full Proposal on or before February 19th, 2024 for FY24 funding consideration. Please note that the submission of Optional Early Concept Paper is OPTIONAL. The offeror can choose to follow or not follow FDA’s recommendation for Stage One Package Submission. Optional Early Concept Paper submission is NOT needed as a qualification step for consideration of a Stage One Package for FY24 BAA Applications.
Inserting link to the BAA recording and materials here:
https://www.fda.gov/science-research/advancing-regulatory-science/2023-fda-broad-agency-announcement-day-10252023 (Copy and paste)
Update #2 ·
In accordance with FAR 6.102(d)(2) and 35.016, the US Food and Drug Administration (FDA) solicits for the acquisition of basic and applied research and development proposals to support regulatory science and innovation through this Broad Agency Announcement (BAA). Research and development activities acquired under this BAA are intended to advance scientific knowledge in specific research areas as well as sub areas of interest defined within the BAA that serve the FDA in accomplishing its mission to protect and promote the health of our nation. Proposals submitted under this announcement are not limited solely to the PSC code "AJ11" specified in this announcement.
FDA funds extramural research through an agency-wide Broad Agency Announcement (BAA) for research and development to support regulatory science and innovation. Join us to learn more about the FY 2024 BAA, and how to apply.
Save the date for the 2023 FDA Broad Agency Announcement (BAA) Day! October 25, 2023. BAA Day for FY23 2024 will be hosted on October 25th, 2023, as a virtual only event and will provide an opportunity to learn more about the application process and FDA’s priorities for regulatory research.
https://www.fda.gov/science-research/2023-fda-broad-agency-announcement-day-10252023
Amendment 01 - Updated to include the list of FY23 BAA Awards
Update #1 ·
In accordance with FAR 6.102(d)(2) and 35.016, the US Food and Drug Administration (FDA) solicits for the acquisition of basic and applied research and development proposals to support regulatory science and innovation through this Broad Agency Announcement (BAA). Research and development activities acquired under this BAA are intended to advance scientific knowledge in specific research areas as well as sub areas of interest defined within the BAA that serve the FDA in accomplishing its mission to protect and promote the health of our nation. Proposals submitted under this announcement are not limited solely to the PSC code "AJ11" specified in this announcement.
FDA funds extramural research through an agency-wide Broad Agency Announcement (BAA) for research and development to support regulatory science and innovation. Join us to learn more about the FY 2024 BAA, and how to apply.
Save the date for the 2023 FDA Broad Agency Announcement (BAA) Day! October 25, 2023. BAA Day for FY23 2024 will be hosted on October 25th, 2023, as a virtual only event and will provide an opportunity to learn more about the application process and FDA’s priorities for regulatory research.
https://www.fda.gov/science-research/2023-fda-broad-agency-announcement-day-10252023
Files
| File | Type | Posted |
|---|---|---|
| Word Format Attachments.docx | DOCX document | |
| FY24 BAA Notice v6.0.pdf | ||
| Timeline Tables.pdf | ||
| Table 1.pdf | ||
| FY24 BAA Notice v5.0.pdf | ||
| FY24 BAA Notice v4.0.pdf | ||
| BAA Deadlines.pdf | ||
| FY24 BAA Notice v3.0.pdf | ||
| BAA_FY2023_Awards.pdf | ||
| BAA_FY2023_Awards_SAM.pdf | ||
| BAA_FY2023_Awards_SAM.pdf | ||
| Cost Appendix 8 Preaward Survey Accounting System.pdf | ||
| BAA Deadlines.pdf | ||
| Cost Appendix 7 Proposal Template.xlsx | XLSX spreadsheet | |
| FY24 BAA Notice v2.0.pdf | ||
| BAA Application Overview.pdf | ||
| Attachment 6 SOW Template.docx | DOCX document |
Show all 17
Notice history
| Notice | Type | Posted |
|---|---|---|
| FY24 FDA Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science Award Notice | Special Notice | |
| This notice | Pre-Solicitation |
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