EO 14398 BAA identification and performance assessment of medical devices in electronic health record data development of a transparent and repeatable framework to enhance medical device integration…

Active Definitive Contract Awarded Last action

Contract number
75F40126C00065
Awardee
Awarding agency
Obligated
$6,515,098

Award facts

Opportunity
Contract value 19% obligated
  • $6,515,098.00 Current, with exercised options
  • $35,194,704.00 Potential, with all options
Completion date 2% complete
  • Current, with exercised options
  • Potential, with all options
Contracting staff
Set-aside
No set-aside
Competition
Full and Open Competition · 1 offer Basic Research
Pricing
Firm Fixed Price
Place of performance
Piscataway, NJ 08854, USA
Legislative mandates

Award details come from SAM.gov/FPDS.

Transactions

Action Obligated Date
Other Administrative Action P00001 $0
Original award $6,515,098

About this award

The Food and Drug Administration awarded a $35.19 million definitive contract to Rutgers The State University Of New Jersey (doing business as RBHS-School of Nursing) on September 15, 2026, for identification and performance assessment of medical devices in electronic health record data and development of a transparent and repeatable framework to enhance medical device integration in real-world evidence generation under Executive Order 14398.

The contract is firm fixed price with no set-aside applied. Place of performance is Piscataway, NJ. The originating solicitation is the FY26 FDA Broad Agency Announcement for Advanced Research and Development of Regulatory Science, posted November 21, 2025, with proposals due February 24, 2026. The announcement seeks basic and applied research supporting regulatory science across FDA-regulated domains, with priority areas including new approach methodologies, analytical and computational methods, biomarkers, clinical outcome assessments, and emerging technologies.

The contract runs through September 23, 2031. Work falls under NAICS 541714 (Research and Development in Biotechnology) and PSC code AJ11 (General Science and Technology R&D Services).

Description

EO 14398 BAA identification and performance assessment of medical devices in electronic health record data development of a transparent and repeatable framework to enhance medical device integration in real world evidence generation

Quick answers

Who was awarded contract 75F40126C00065?

75F40126C00065 was awarded to Rutgers The State University Of New Jersey by Food and Drug Administration (Department of Health and Human Services) on September 15, 2026.

How much is contract 75F40126C00065 worth?

The government has obligated $6,515,098 on 75F40126C00065. Its potential value, with all options, is $35,194,704.

Was contract 75F40126C00065 competed?

The extent of competition for 75F40126C00065 was full and open competition. The government received 1 offer.

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