Special notice
FY25 FDA Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science
FDABAA-25-00123
Food and Drug Administration, FDA Office of Acquisitions and Grants Services. Research and Development in Biotechnology (except Nanobiotechnology).
Awarded
$749,661.00 obligated so far on USAspending
Description
As published on SAM.gov.
Amendment 05 - The BAA Notice has been updated to version 6 with various changes throughout.
Amendment 04 - The BAA Notice has been updated to version 5 with various changes throughout. Table 1 and attachment 5 have also been updated and included seperately. The response date has been changed to March 04th at 1159 PM EST.
Amendment 03 - The BAA Notice has been updated to version 4 with various changes throughout, Table 1 and attachments 4 and 5 have also been updated and included seperately.
Amendment 02 - The BAA Notice has been updated to version 3 with various changes throughout.
Amendment 01 - The BAA Notice has been updated to version 2 with various changes throughout, and table 1 has been updated and included seperately. 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 2025 BAA, and how to apply. Save the date for the 2024 FDA Broad Agency Announcement (BAA) Day!
November 14th, 2024. BAA Day for FY25 2024 will be hosted on November 14th, 2024, 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/advancing-regulatory-science/2024-fda-broad-agency-announcement-day-11142024
The contract, on USAspending
Federal procurement data the awarding office reported to FPDS, matched to this solicitation by its number.
- Recipient
- Duke University
- UEI
- TP7EK8DZV6N5
- CAGE
- 4B478
- Vendor location
- Durham, NC
- Contract
- 75F40125C00053, definitive contract
- Obligated
- $749,661.00
- Actions
- 1 between September 8, 2025 and September 8, 2025
- Competition
- Full and Open Competition, 1 offer received
- Set-aside reported
- No Set Aside Used.
- Described as
- The Food and Drug Administration (Fda) Is Responsible for Protecting the Public Health by Assuring the Safety, Efficacy, and Security of Human and Veterinary Drugs, Biological Products, Medical Devices, Our Nation?s Food Supply, Cosmetics, and Produc
- Match
- solicitation number FDABAA2500123 equals the FPDS solicitation identifier; same sub-agency 7524 (high confidence)
- Record
- USAspending award page
- Recipient
- The Johns Hopkins University
- UEI
- FTMTDMBR29C7
- CAGE
- 5L406
- Vendor location
- Baltimore, MD
- Contract
- 75F40125C00054, definitive contract
- Obligated
- $517,607.00
- Actions
- 2 between September 10, 2025 and August 14, 2026
- Competition
- Full and Open Competition, 1 offer received
- Set-aside reported
- No Set Aside Used.
- Described as
- The Food and Drug Administration?s Center for Biologics Evaluation and Research (Cber) Biologics Effectiveness and Safety Innovative Methods (Best Im) Program Enhances the Safety of Vaccines, Blood Products, and Biologics Through High-Quality Analy
- Match
- solicitation number FDABAA2500123 equals the FPDS solicitation identifier; same sub-agency 7524 (high confidence)
- Record
- USAspending award page
- Recipient
- Universitat St. Gallen
- UEI
- LLK6D5M1UAF1
- CAGE
- SZA17
- Vendor location
- St. Gallen
- Contract
- 75F40125C00063, definitive contract
- Obligated
- $515,769.89
- Actions
- 1 between September 8, 2025 and September 8, 2025
- Competition
- Full and Open Competition, 1 offer received
- Set-aside reported
- No Set Aside Used.
- Described as
- The Purpose of This Contract Is to Conduct Research and Develop Tools to Strengthen Post-Market Surveillance of Fda-Regulated Products. the Objective Is to Apply Advanced Analytics and Hybrid Artificial Intelligence to Improve Risk Identification Usi
- Match
- solicitation number FDABAA2500123 equals the FPDS solicitation identifier; same sub-agency 7524 (high confidence)
- Record
- USAspending award page
- Recipient
- Genentech Inc.
- UEI
- F7F8GZXL7Q93
- CAGE
- 1HZ12
- Vendor location
- South San Francisco, CA
- Contract
- 75F40125C00069, definitive contract
- Obligated
- $1,085,530.00
- Actions
- 3 between September 11, 2025 and June 11, 2026
- Competition
- Full and Open Competition, 1 offer received
- Set-aside reported
- No Set Aside Used.
- Described as
- This Project Focuses on Addressing Critical Challenges in the Design and Analysis of Hybrid Randomized Controlled Trials (Rcts) in Longitudinal Settings. the First Goal Is to Develop Causal Methodologies for Managing Diverse Missing Data Patterns in
- Match
- solicitation number FDABAA2500123 equals the FPDS solicitation identifier; same sub-agency 7524 (high confidence)
- Record
- USAspending award page
- Recipient
- Hartford Hospital
- UEI
- UJGNPDP2ETM3
- CAGE
- 39AW3
- Vendor location
- Hartford, CT
- Contract
- 75F40125C00085, definitive contract
- Obligated
- $324,978.00
- Actions
- 2 between September 22, 2025 and April 21, 2026
- Competition
- Full and Open Competition, 1 offer received
- Set-aside reported
- No Set Aside Used.
- Described as
- Baa-Fy25c3bp2 - Pharmacodynamics of Daptomycin Against Enterococcus Faeciumand Enterococcus Faecalis in the Murine Thigh Infection Model.
- Match
- solicitation number FDABAA2500123 equals the FPDS solicitation identifier; same sub-agency 7524 (high confidence)
- Record
- USAspending award page
- Recipient
- Rutgers, the State University
- UEI
- M1LVPE5GLSD9
- CAGE
- 4B883
- Vendor location
- New Brunswick, NJ
- Contract
- 75F40125C00089, definitive contract
- Obligated
- $999,347.00
- Actions
- 1 between September 24, 2025 and September 24, 2025
- Competition
- Full and Open Competition, 1 offer received
- Set-aside reported
- No Set Aside Used.
- Described as
- Baa# Fy25c1bp27 - Development and Implementation of Ai/Ml Toolbox for Digitalization of Advanced Modular Continuous Api Manufacturing Process
- Match
- solicitation number FDABAA2500123 equals the FPDS solicitation identifier; same sub-agency 7524 (high confidence)
- Record
- USAspending award page
- Recipient
- Dna Hive LLC
- UEI
- ZULRXE8XYEM3
- CAGE
- 8B9Q6
- Vendor location
- Rockville, MD
- Contract
- 75F40125C00095, definitive contract
- Obligated
- $3,090,714.59
- Actions
- 1 between September 23, 2025 and September 23, 2025
- Competition
- Full and Open Competition, 1 offer received
- Set-aside reported
- No Set Aside Used.
- Described as
- Baa# Fy25c3ap3 - (H20) a Next Generation Medical Countermeasures Scientific Platform for Regulatory Evaluation and Preparedness
- Match
- solicitation number FDABAA2500123 equals the FPDS solicitation identifier; same sub-agency 7524 (high confidence)
- Record
- USAspending award page
- Recipient
- Florida State University
- UEI
- JF2BLNN4PJC3
- CAGE
- 3S772
- Vendor location
- Tallahassee, FL
- Contract
- 75F40125C00105, definitive contract
- Obligated
- $2,277,208.00
- Actions
- 1 between September 30, 2025 and September 30, 2025
- Competition
- Competed Under SAP, 1 offer received
- Set-aside reported
- No Set Aside Used.
- Described as
- Baa_fy25c3cp4_modernizing and Decentralizing Clinical Trials with Ai, Digital Health, and Community-Driven Innovation to Deliver Better Health for All American.
- Match
- solicitation number FDABAA2500123 equals the FPDS solicitation identifier; same sub-agency 7524 (high confidence)
- Record
- USAspending award page
Publications
Every notice SAM.gov issued under this solicitation number, oldest first. Each is a separate record on SAM.
October 3, 2024
Special notice
Due February 24, 2025 at 11:59 PM EST. SAM.gov, notice 1811e00d132349d08cebe07ff77497ed
October 3, 2024
Special notice
Due February 24, 2025 at 11:59 PM EST. SAM.gov, notice c3e35e83134c40e5b96dde9c65f5c23a
November 15, 2024
Special notice
Due February 24, 2025 at 11:59 PM EST. SAM.gov, notice fa6371f653794519a7f4476f749182a3
November 19, 2024
Special notice
Due February 24, 2025 at 11:59 PM EST. SAM.gov, notice 96ecb34be4fa4298a37c02e9730afcae
December 6, 2024
Special notice
Due February 24, 2025 at 11:59 PM EST. SAM.gov, notice 4c3b6b34359847d6803c24b12e983834
February 24, 2025
Special notice
Due March 4, 2025 at 11:59 PM EST. SAM.gov, notice 2c6ab106bdf7498ab0159169e82ec5a0
February 24, 2025
Special notice
Due March 4, 2025 at 11:59 PM EST. SAM.gov, notice 472578a7ab5342e6bbeef2645382c149
February 26, 2025
Special notice
Due March 4, 2025 at 11:59 PM EST. SAM.gov, notice 6f90d6ca429b4c9fb3068a26c37a0946
February 26, 2025
Special notice
Due March 4, 2025 at 11:59 PM EST. SAM.gov, notice cb1140c96dc941cbb2c5f0769d83d9d1
Points of contact
- Ian WeissIan.Weiss@fda.hhs.gov3017965728