EO14398 - broad agency announcement (BAA) FY26C1IP3 - advanced research and development of regulatory science - core clinical outcome assessment grant program
Active Definitive Contract Awarded Last action
- Contract number
- 75F40126C00112
- Awardee
-
Duke University UEI TP7EK8DZV6N5
- Awarding agency
-
Food and Drug Administration
Department of Health and Human Services
- Obligated
- $1,456,427
Award facts
- Opportunity
-
- FY26 FDA Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science Special Notice · FDABAA2600123 · Posted Nov 21, 2025
- Contract value 100% obligated
- $1,456,427.00 Current and potential, with all options
- Completion date 2% complete
- Current and potential, with all options
- Contracting staff
- 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
- Set-aside
- No set-aside
- Competition
- Full and Open Competition · 1 offer Basic Research
- Pricing
- Firm Fixed Price
- Place of performance
- Durham, NC 27701, USA
- Legislative mandates
-
- Employment Eligibility Verification (E-Verify) FAR subpart 22.18
- Service Contract Inventory FAR subpart 4.17
Award details come from SAM.gov/FPDS.
About this award
The Food and Drug Administration awarded a $1,456,427 definitive contract to Duke University for advanced research and development in regulatory science under the Core Clinical Outcome Assessment Grant Program on September 30, 2026.
The originating BAA (FY26C1IP3), posted November 21, 2025, seeks basic and applied research to advance scientific knowledge in regulatory science domains aligned with FDA mission priorities, including modernizing development and evaluation of FDA-regulated products, strengthening post-market surveillance and labeling, and invigorating public health preparedness and response. The solicitation encompasses research priority areas including new approach methodologies, advanced manufacturing, analytical and computational methods, biomarkers, and clinical outcome assessments. Proposals were evaluated under a two-stage submission process with Stage One Submittal due February 24, 2026.
Work is performed in Durham, North Carolina. The contract runs through September 29, 2028, with firm fixed-price terms. The award carries no set-aside designation and was issued under FAR 6.102(d)(2) and 35.016 authority. NAICS code 541714 (Research and Development in Biotechnology) and PSC code AJ11 (General Science and Technology R&D Services) align with the solicitation scope.
Quick answers
Who was awarded contract 75F40126C00112?
75F40126C00112 was awarded to Duke University by Food and Drug Administration (Department of Health and Human Services) on September 30, 2026.
How much is contract 75F40126C00112 worth?
The government has obligated $1,456,427 on 75F40126C00112.
Was contract 75F40126C00112 competed?
The extent of competition for 75F40126C00112 was full and open competition. The government received 1 offer.
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