# FY25 FDA Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science Canonical: https://abierto.us/opportunities/fdabaa2500123 - Solicitation number: FDABAA-25-00123 - Notice type: Special notice - Status: Awarded to Duke University - Department: Department of Health and Human Services - Agency: Food and Drug Administration - Contracting office: FDA Office of Acquisitions and Grants Services (75FDA1) - NAICS: 541714 Research and Development in Biotechnology (except Nanobiotechnology) - Product or service code: AJ11 General Science And Technology R&D Services; General Science And Technology; Basic Research - Place of performance: Silver Spring, Maryland - County: Montgomery County (FIPS 24031). https://abierto.us/counties/montgomery-county-md-24031 - City: Silver Spring. https://abierto.us/cities/silver-spring-md-2472450 - First posted: October 3, 2024 - Last posted: February 26, 2025 - SAM.gov: https://sam.gov/workspace/contract/opp/cb1140c96dc941cbb2c5f0769d83d9d1/view ## Description 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 ## Award on USAspending - Recipient: Duke University (UEI TP7EK8DZV6N5) - Contract: 75F40125C00053, definitive contract - Obligated: $749,661.00 - Competition: Full and Open Competition, 1 offers received - Link: solicitation number FDABAA2500123 equals the FPDS solicitation identifier; same sub-agency 7524 (high confidence) - Record: https://www.usaspending.gov/award/CONT_AWD_75F40125C00053_7524_-NONE-_-NONE-/ - Recipient: The Johns Hopkins University (UEI FTMTDMBR29C7) - Contract: 75F40125C00054, definitive contract - Obligated: $517,607.00 - Competition: Full and Open Competition, 1 offers received - Link: solicitation number FDABAA2500123 equals the FPDS solicitation identifier; same sub-agency 7524 (high confidence) - Record: https://www.usaspending.gov/award/CONT_AWD_75F40125C00054_7524_-NONE-_-NONE-/ - Recipient: Universitat St. Gallen (UEI LLK6D5M1UAF1) - Contract: 75F40125C00063, definitive contract - Obligated: $515,769.89 - Competition: Full and Open Competition, 1 offers received - Link: solicitation number FDABAA2500123 equals the FPDS solicitation identifier; same sub-agency 7524 (high confidence) - Record: https://www.usaspending.gov/award/CONT_AWD_75F40125C00063_7524_-NONE-_-NONE-/ - Recipient: Genentech Inc. (UEI F7F8GZXL7Q93) - Contract: 75F40125C00069, definitive contract - Obligated: $1,085,530.00 - Competition: Full and Open Competition, 1 offers received - Link: solicitation number FDABAA2500123 equals the FPDS solicitation identifier; same sub-agency 7524 (high confidence) - Record: https://www.usaspending.gov/award/CONT_AWD_75F40125C00069_7524_-NONE-_-NONE-/ - Recipient: Hartford Hospital (UEI UJGNPDP2ETM3) - Contract: 75F40125C00085, definitive contract - Obligated: $324,978.00 - Competition: Full and Open Competition, 1 offers received - Link: solicitation number FDABAA2500123 equals the FPDS solicitation identifier; same sub-agency 7524 (high confidence) - Record: https://www.usaspending.gov/award/CONT_AWD_75F40125C00085_7524_-NONE-_-NONE-/ - Recipient: Rutgers, the State University (UEI M1LVPE5GLSD9) - Contract: 75F40125C00089, definitive contract - Obligated: $999,347.00 - Competition: Full and Open Competition, 1 offers received - Link: solicitation number FDABAA2500123 equals the FPDS solicitation identifier; same sub-agency 7524 (high confidence) - Record: https://www.usaspending.gov/award/CONT_AWD_75F40125C00089_7524_-NONE-_-NONE-/ - Recipient: Dna Hive LLC (UEI ZULRXE8XYEM3) - Contract: 75F40125C00095, definitive contract - Obligated: $3,090,714.59 - Competition: Full and Open Competition, 1 offers received - Link: solicitation number FDABAA2500123 equals the FPDS solicitation identifier; same sub-agency 7524 (high confidence) - Record: https://www.usaspending.gov/award/CONT_AWD_75F40125C00095_7524_-NONE-_-NONE-/ - Recipient: Florida State University (UEI JF2BLNN4PJC3) - Contract: 75F40125C00105, definitive contract - Obligated: $2,277,208.00 - Competition: Competed Under SAP, 1 offers received - Link: solicitation number FDABAA2500123 equals the FPDS solicitation identifier; same sub-agency 7524 (high confidence) - Record: https://www.usaspending.gov/award/CONT_AWD_75F40125C00105_7524_-NONE-_-NONE-/ ## Publications - October 3, 2024: Special notice, due February 24, 2025 at 11:59 PM EST. Notice 1811e00d132349d08cebe07ff77497ed. https://sam.gov/workspace/contract/opp/1811e00d132349d08cebe07ff77497ed/view - October 3, 2024: Special notice, due February 24, 2025 at 11:59 PM EST. Notice c3e35e83134c40e5b96dde9c65f5c23a. https://sam.gov/workspace/contract/opp/c3e35e83134c40e5b96dde9c65f5c23a/view - November 15, 2024: Special notice, due February 24, 2025 at 11:59 PM EST. Notice fa6371f653794519a7f4476f749182a3. https://sam.gov/workspace/contract/opp/fa6371f653794519a7f4476f749182a3/view - November 19, 2024: Special notice, due February 24, 2025 at 11:59 PM EST. Notice 96ecb34be4fa4298a37c02e9730afcae. https://sam.gov/workspace/contract/opp/96ecb34be4fa4298a37c02e9730afcae/view - December 6, 2024: Special notice, due February 24, 2025 at 11:59 PM EST. Notice 4c3b6b34359847d6803c24b12e983834. https://sam.gov/workspace/contract/opp/4c3b6b34359847d6803c24b12e983834/view - February 24, 2025: Special notice, due March 4, 2025 at 11:59 PM EST. Notice 2c6ab106bdf7498ab0159169e82ec5a0. https://sam.gov/workspace/contract/opp/2c6ab106bdf7498ab0159169e82ec5a0/view - February 24, 2025: Special notice, due March 4, 2025 at 11:59 PM EST. Notice 472578a7ab5342e6bbeef2645382c149. https://sam.gov/workspace/contract/opp/472578a7ab5342e6bbeef2645382c149/view - February 26, 2025: Special notice, due March 4, 2025 at 11:59 PM EST. Notice 6f90d6ca429b4c9fb3068a26c37a0946. https://sam.gov/workspace/contract/opp/6f90d6ca429b4c9fb3068a26c37a0946/view - February 26, 2025: Special notice, due March 4, 2025 at 11:59 PM EST. Notice cb1140c96dc941cbb2c5f0769d83d9d1. https://sam.gov/workspace/contract/opp/cb1140c96dc941cbb2c5f0769d83d9d1/view ## Points of contact - Ian Weiss, Ian.Weiss@fda.hhs.gov, 3017965728 --- Source: SAM.gov Contract Opportunities bulk extract and USAspending.gov award data. Confirm deadlines on SAM.gov before responding. Cite https://abierto.us/opportunities/fdabaa2500123.