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…
Active Definitive Contract Awarded Last action
- Contract number
- 75F40125C00069
- Awardee
-
Genentech Inc. UEI F7F8GZXL7Q93
- Awarding agency
-
Food and Drug Administration
Department of Health and Human Services
- Obligated
- $1,085,530
Award facts
- Opportunity
-
- FY25 FDA Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science Special Notice · FDABAA2500123 · Posted Oct 3, 2024
- Contract value 100% obligated
- $1,085,530.00 Current and potential, with all options
- Completion date 24% 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
- Silver Spring, MD 20993, USA
Award details come from SAM.gov/FPDS.
Transactions
| Action | Obligated | Date |
|---|---|---|
| Other Administrative Action | $0 | |
| Other Administrative Action | $0 | |
| Original award | $1,085,530 |
About this award
The Food and Drug Administration awarded a $1,085,530 definitive contract to Genentech Inc. on September 11, 2025, for advanced research and development in regulatory science addressing hybrid randomized controlled trials in longitudinal settings, with emphasis on causal methodologies for managing diverse missing data patterns.
The contract was issued under a Fiscal Year 2025 Broad Agency Announcement for Advanced Research and Development of Regulatory Science, which solicited proposals across multiple research domains supporting the FDA's regulatory mission. The originating BAA, posted October 3, 2024, with a full-proposal deadline of February 24, 2025, encompasses three primary research charges: modernizing development and evaluation of FDA-regulated products, strengthening post-market surveillance and labeling, and enhancing public health preparedness and response. Place of performance is Silver Spring, MD. The contract carries a firm fixed-price structure with an ultimate completion date of March 29, 2030.
Description
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
Quick answers
Who was awarded contract 75F40125C00069?
75F40125C00069 was awarded to Genentech Inc. by Food and Drug Administration (Department of Health and Human Services) on September 11, 2025.
How much is contract 75F40125C00069 worth?
The government has obligated $1,085,530 on 75F40125C00069.
Was contract 75F40125C00069 competed?
The extent of competition for 75F40125C00069 was full and open competition. The government received 1 offer.
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