Clinical and laboratory applied regulatory science
Ended Indefinite Delivery Contract Awarded Last action
- Contract number
- 75F40119D10032
- Awardee
-
Spaulding Clinical Research, LLC UEI HERBKHMPKQN5
- Awarding agency
-
Food and Drug Administration
Department of Health and Human Services
- Task orders
- 5 $19,660,419 obligated
Award facts
- Opportunity
-
- Clinical and Laboratory Applied Regulatory Science Solicitation · FDARFP191208111 · Posted Jun 17, 2019
- Combined order value
- $19,660,419 Current and potential, with all options
- Last date to order 100% complete
- IDV ceiling 66% used
- $30,000,000.00
- Award type
- Single award
- Who can order
- Only the awarding agency
- 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 · 4 offers Negotiated Proposal / Quote
- Pricing
- Labor Hours
Award details come from SAM.gov/FPDS.
About this IDV
The U.S. Food and Drug Administration (FDA), a civilian agency within the Department of Health and Human Services, awarded a $30 million single-award Indefinite Delivery Indefinite Quantity (IDIQ) contract to Spaulding Clinical Research, LLC, a self-certified small disadvantaged business, for-profit organization, and limited liability company. The IDIQ contract, awarded in 2019 with a last ordering date of September 2024, enables the FDA to issue task orders to Spaulding for clinical and laboratory applied regulatory science services. These services support the FDA's regulatory science programs and assist in regulatory decision-making across product lifecycles. Specific tasks include conducting clinical pharmacology studies, QT prolongation and electrocardiogram studies to evaluate cardiac safety, and providing regulatory process expertise. The work is performed at Spaulding's facilities in West Bend, Wisconsin and Silver Spring, Maryland, and the contract does not utilize any set-aside designations.
To date, the FDA has issued several firm fixed-price delivery orders under this IDIQ contract, ranging from $215,502 to $6.6 million in value, with periods of performance typically spanning 3-5 years. These delivery orders provide the FDA with a range of clinical and laboratory applied regulatory science services to support its mission of ensuring the safety and effectiveness of drugs, vaccines, biologics, and medical devices throughout their product lifecycles.
Task orders
Transactions
| Action | Obligated | Date |
|---|---|---|
| Other Administrative Action | $0 | |
| Other Administrative Action | $0 | |
| Original award | $0 |
Quick answers
Who was awarded contract 75F40119D10032?
75F40119D10032 was awarded to Spaulding Clinical Research, LLC by Food and Drug Administration (Department of Health and Human Services) on August 19, 2019.
How much is contract 75F40119D10032 worth?
Orders under 75F40119D10032 have obligated $19,660,419. 75F40119D10032's own ceiling is $30,000,000.
How many orders have been placed under contract 75F40119D10032?
5 orders have been placed under 75F40119D10032, the latest on September 28, 2023.
Who can order from contract 75F40119D10032?
75F40119D10032 is a single award indefinite delivery contract. Only the awarding agency can place orders on it.
Was contract 75F40119D10032 competed?
The extent of competition for 75F40119D10032 was full and open competition. The government received 4 offers.
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