In-vitro quality metrics approach for bioequivalence demonstration between intramammary infusion products of animals.
Ended Definitive Contract Awarded Last action
- Contract number
- 75F40122C00123
- Awardee
-
Texas A & M University System Health Science Center UEI HFT7XTHB6563
- Awarding agency
-
Food and Drug Administration
Department of Health and Human Services
- Obligated
- $297,072
Award facts
- Opportunity
-
- FY22 FDA Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science Solicitation · FDABAA2200123 · Posted Nov 10, 2021
- Contract value 100% obligated
- $297,071.74 Current and potential, with all options
- Completion date 100% complete
- Current and potential, with all options
- Contracting staff
- NAICS code
- 611310 Colleges, Universities, and Professional Schools
- Set-aside
- No set-aside
- Competition
- Full and Open Competition · 165 offers Negotiated Proposal / Quote
- Pricing
- Firm Fixed Price
- Place of performance
- College Station, TX 77843, USA
- Legislative mandates
-
- Employment Eligibility Verification (E-Verify) FAR subpart 22.18
Award details come from SAM.gov/FPDS.
Transactions
| Action | Obligated | Date |
|---|---|---|
| Close Out | -$3,183 | |
| Original award | $300,255 |
About this award
The Food and Drug Administration (FDA) awarded a $297,071.74 definitive contract with a firm fixed price to Texas A&M University System Health Science Center to conduct research on in-vitro quality metrics approaches for bioequivalence demonstration between intramammary infusion products for animals. The award was issued on September 27, 2022, with an ultimate completion date of September 29, 2024, and work is being performed in College Station, Texas. This contract emerged from an FDA Broad Agency Announcement posted in November 2021 that solicited research and development proposals to advance regulatory science through development of new tools, standards, and approaches supporting safety, efficacy, and quality evaluations of FDA-regulated products. The solicitation anticipated multiple awards based on proposal quality and available funding and did not restrict consideration to current contractors or include set-aside designations.
Texas A&M University System Health Science Center, a prominent research institution with extensive experience conducting biomedical research for federal agencies, is well-positioned to deliver on this regulatory science initiative. The contract deliverables support the FDA's mission to establish robust scientific methodologies for evaluating veterinary pharmaceutical products, specifically focusing on developing quality metrics that can demonstrate bioequivalence without requiring extensive in-vivo testing. This research aligns with the FDA's broader regulatory science program objectives to modernize product evaluation approaches and improve efficiency in the approval process for animal health products.
Quick answers
Who was awarded contract 75F40122C00123?
75F40122C00123 was awarded to Texas A & M University System Health Science Center by Food and Drug Administration (Department of Health and Human Services) on September 27, 2022.
How much is contract 75F40122C00123 worth?
The government has obligated $297,072 on 75F40122C00123.
Was contract 75F40122C00123 competed?
The extent of competition for 75F40122C00123 was full and open competition. The government received 165 offers.
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