Clinical and laboratory applied regulatory science
Ended Awarded Last action
- Contract number
- 75F40120F19003
- Awardee
-
Spaulding Clinical Research, LLC UEI HERBKHMPKQN5
- Awarding agency
-
Food and Drug Administration
Department of Health and Human Services
- Obligated
- $5,454,072
Award facts
- Contract value 100% obligated
- $5,454,071.53 Current and potential, with all options
- Completion date 100% complete
- Current and potential, with all options
- Contracting staff
- NAICS code
- 541714 Research and Development in Biotechnology (except Nanobiotechnology)
- PSC
- 6640 Laboratory Equipment And Supplies
- Set-aside
- No set-aside
- Competition
- Full and Open Competition Negotiated Proposal / Quote
- 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 | |
| Other Administrative Action | $0 | |
| Supplemental Agreement for work within scope | $2,985,000 | |
| Other Administrative Action | $451,063 | |
| Other Administrative Action | $0 | |
| Original award | $2,018,009 |
About this award
This is a firm fixed price delivery order contract awarded by the U.S. Food and Drug Administration (FDA) to Spaulding Clinical Research, LLC, a self-certified small disadvantaged business. The $5,454,071.53 contract is for the provision of clinical and laboratory applied regulatory science services to support the FDA's regulatory science programs and assist with regulatory decision-making across product lifecycles. The services include conducting clinical pharmacology studies, QT prolongation and electrocardiogram studies to evaluate cardiac safety, and providing regulatory process expertise. Spaulding Clinical Research performs this work at its facilities in West Bend, Wisconsin and Silver Spring, Maryland. This delivery order is part of a larger $30 million single award Indefinite Delivery Indefinite Quantity (IDIQ) contract the company holds with the FDA for clinical and laboratory applied regulatory science services, which was awarded in 2019 with a last ordering date of September 2024.
Quick answers
Who was awarded contract 75F40120F19003?
75F40120F19003 was awarded to Spaulding Clinical Research, LLC by Food and Drug Administration (Department of Health and Human Services) on September 29, 2020.
How much is contract 75F40120F19003 worth?
The government has obligated $5,454,072 on 75F40120F19003.
Is contract 75F40120F19003 an order under another contract?
Yes. 75F40120F19003 is a delivery order under 75F40119D10032, an indefinite delivery contract.
Was contract 75F40120F19003 competed?
The extent of competition for 75F40120F19003 was full and open competition.
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