FY23 FDA Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science
Closed Solicitation Posted
This opportunity was awarded. See the award notice from .
- Solicitation number
- FDABAA-23-00123
- 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
The Food and Drug Administration seeks advanced research and development proposals through a Broad Agency Announcement to further regulatory science and innovation across three key research areas: modernizing product development and evaluation; strengthening post-market surveillance and labeling; and invigorating public health preparedness and response. Proposals must address at least one research area and sub-area defined in the BAA and will be evaluated through a two-stage submission and review process, with an initial deadline of January 23, 2023 to be considered for fiscal year 2023 awards.
There is no set-aside designated. Past awardees under previous solicitations include Georgia Tech, University of Wisconsin, University of Michigan, and Deloitte Consulting. Multiple awards are anticipated depending on quality and available funding. Budgets may range from $250,000 to $2 million over one to five years. Research areas include evaluation of drugs, devices, biologics, and tobacco products. The place of performance is Silver Spring, Maryland.
Notice text
6 versions
Update #6 · Latest ·
Announcement updated 18 May 2023 to include the following -
All requests for full proposals have been sent out as applicable. If you did not receive one, do not invite letters will be sent out to all other white paper submitters OOA 30 June 2023.
All other terms and conditions remain unchanged.
2022 FDA Broad Agency Announcement Day
FDA funds extramural research through an agency-wide Broad Agency Announcement (BAA) for research and development to support regulatory science and innovation.
A recording of the full event (4 hours, 12 minutes), including closed captioning and an audio transcript, is now available. https://fda.zoomgov.com/rec/share/I3aM_Gjz7lAb3KVJmJI1lYV8Mqo3aGgL9_oI3jx6fFirkVz8Z9xKvxKWV4Pv5AJr.ubCqbg7TUd7XBSS2?startTime=1670338801000
Slides from this event are posted as well, under Event Materials.
https://www.fda.gov/science-research/fda-broad-agency-announcement-day-2022-12062022
Additional Q&A attached.
Announcment amendment 00002 updated to correct language on page 19.
Announcement PDF updated to correct the Missing Information on Page 40, to update the research areas. Additionally, the BAA day question and answers have been added, as well as the list of awards from the 2022 BAA
All other terms and conditions remain unchanged.
Announcement PDF updated to correct the whitepaper due date to January 23rd, 2023.
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 2023 BAA, and how to apply.
Stay tuned. We'll add more information to this page, including how to attend this virtual event, as it becomes available.
Link below:
https://www.fda.gov/science-research/fda-broad-agency-announcement-day-2022-12062022
Update #5 ·
2022 FDA Broad Agency Announcement Day
FDA funds extramural research through an agency-wide Broad Agency Announcement (BAA) for research and development to support regulatory science and innovation.
A recording of the full event (4 hours, 12 minutes), including closed captioning and an audio transcript, is now available. https://fda.zoomgov.com/rec/share/I3aM_Gjz7lAb3KVJmJI1lYV8Mqo3aGgL9_oI3jx6fFirkVz8Z9xKvxKWV4Pv5AJr.ubCqbg7TUd7XBSS2?startTime=1670338801000
Slides from this event are posted as well, under Event Materials.
https://www.fda.gov/science-research/fda-broad-agency-announcement-day-2022-12062022
Additional Q&A attached.
Announcment amendment 00002 updated to correct language on page 19.
Announcement PDF updated to correct the Missing Information on Page 40, to update the research areas. Additionally, the BAA day question and answers have been added, as well as the list of awards from the 2022 BAA
All other terms and conditions remain unchanged.
Announcement PDF updated to correct the whitepaper due date to January 23rd, 2023.
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 2023 BAA, and how to apply.
Stay tuned. We'll add more information to this page, including how to attend this virtual event, as it becomes available.
Link below:
https://www.fda.gov/science-research/fda-broad-agency-announcement-day-2022-12062022
Update #4 ·
Announcment amendment 00002 updated to correct language on page 19.
Announcement PDF updated to correct the Missing Information on Page 40, to update the research areas. Additionally, the BAA day question and answers have been added, as well as the list of awards from the 2022 BAA
All other terms and conditions remain unchanged.
Announcement PDF updated to correct the whitepaper due date to January 23rd, 2023.
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 2023 BAA, and how to apply.
Stay tuned. We'll add more information to this page, including how to attend this virtual event, as it becomes available.
Link below:
https://www.fda.gov/science-research/fda-broad-agency-announcement-day-2022-12062022
Update #3 ·
Announcement PDF updated to correct the Missing Information on Page 40, to update the research areas. Additionally, the BAA day question and answers have been added, as well as the list of awards from the 2022 BAA
All other terms and conditions remain unchanged.
Announcement PDF updated to correct the whitepaper due date to January 23rd, 2023.
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 2023 BAA, and how to apply.
Stay tuned. We'll add more information to this page, including how to attend this virtual event, as it becomes available.
Link below:
https://www.fda.gov/science-research/fda-broad-agency-announcement-day-2022-12062022
Update #2 ·
Announcement PDF updated to correct the whitepaper due date to January 23rd, 2023.
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 2023 BAA, and how to apply.
Stay tuned. We'll add more information to this page, including how to attend this virtual event, as it becomes available.
Link below:
https://www.fda.gov/science-research/fda-broad-agency-announcement-day-2022-12062022
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 2023 BAA, and how to apply.
Stay tuned. We'll add more information to this page, including how to attend this virtual event, as it becomes available.
Link below:
https://www.fda.gov/science-research/fda-broad-agency-announcement-day-2022-12062022
Files
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Notice history
| Notice | Type | Posted |
|---|---|---|
| FY23 FDA Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science | Award Notice | |
| This notice | Solicitation |
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