BAA eetwp #63: a standardized framework to support FDA qualification of complex in vitro models for use in regulatory submissions.
Ended Definitive Contract Awarded Last action
- Contract number
- 75F40122C00196
- Awardee
-
The Critical Path Institute UEI KAEPADMRKHD3
- Awarding agency
-
Food and Drug Administration
Department of Health and Human Services
- Obligated
- $2,384,472
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 54% obligated
-
- $2,384,471.86 Current, with exercised options
- $4,418,256.96 Potential, with all options
- Completion date 100% complete
-
- Current, with exercised options
- Potential, with all options
- Contracting staff
- NAICS code
- 541714 Research and Development in Biotechnology (except Nanobiotechnology)
- Set-aside
- No set-aside
- Competition
- Full and Open Competition · 165 offers Negotiated Proposal / Quote
- Pricing
- Cost No Fee
- Place of performance
- Silver Spring, MD 20993, 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.
Transactions
| Action | Obligated | Date |
|---|---|---|
| Terminate for Convenience | $0 | |
| Exercise an Option | $628,206 | |
| Change Order | $0 | |
| Other Administrative Action | $723,521 | |
| Other Administrative Action | $0 | |
| Exercise an Option | $95,006 | |
| Original award | $937,738 |
About this award
This federal contract award is for $4,418,256.96 to The Critical Path Institute (C-Path), a non-profit organization, by the Food and Drug Administration (FDA). The contract was awarded under the FDA's Broad Agency Announcement (BAA) EETWP #63 to develop "A STANDARDIZED FRAMEWORK TO SUPPORT FDA QUALIFICATION OF COMPLEX IN VITRO MODELS FOR USE IN REGULATORY SUBMISSIONS."
The BAA solicits research and development proposals to advance regulatory science in various areas of interest for FDA-regulated products. This contract will fund C-Path's efforts to create tools, standards, and approaches that enhance decision-making in drug development and regulatory science. C-Path has received prior federal contracts and grants from the FDA to support its work in developing biomarkers, patient-reported outcome measures, and other drug development tools. This contract is not set aside for any specific business type.
Quick answers
Who was awarded contract 75F40122C00196?
75F40122C00196 was awarded to The Critical Path Institute by Food and Drug Administration (Department of Health and Human Services) on September 26, 2022.
How much is contract 75F40122C00196 worth?
The government has obligated $2,384,472 on 75F40122C00196. Its potential value, with all options, is $4,418,257.
Was contract 75F40122C00196 competed?
The extent of competition for 75F40122C00196 was full and open competition. The government received 165 offers.
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