Sentinel pdufa VII commitment for pregnancy safety demonstration projects and negative control tool development
Active Awarded Last action
- Contract number
- 75F40124F19012
- Awardee
-
Harvard Pilgrim Health Care, Inc. UEI NZVVQ8GNVX65
- Awarding agency
-
Food and Drug Administration
Department of Health and Human Services
- Obligated
- $9,714,571
Award facts
- Contract value 100% obligated
- $9,714,570.87 Current and potential, with all options
- Completion date 74% complete
- Current and potential, with all options
- Contracting staff
- NAICS code
- 518210 Computing Infrastructure Providers, Data Processing, Web Hosting, and Related Services
- Set-aside
- No set-aside
- Competition
- Full and Open Competition Negotiated Proposal / Quote
- Pricing
- Time and Materials
- Place of performance
- Wellesley Hills, Wellesley, MA 02481, 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 |
|---|---|---|
| Supplemental Agreement for work within scope | $1,000,000 | |
| Exercise an Option | $1,000,000 | |
| Supplemental Agreement for work within scope | $0 | |
| Other Administrative Action | $0 | |
| Original award | $7,714,571 |
About this award
The Food and Drug Administration (FDA) awarded a $9.7 million delivery order contract modification to Harvard Pilgrim Health Care Inc. on March 29, 2024, to support the Sentinel System's PDUFA VII commitment for pregnancy safety demonstration projects and negative control tool development. This modification (MOD P00004) adds $1 million to Line 12 of the contract to maintain mother and infant record linkages across a subset of Sentinel Data Distributed (SDD) partners, including conducting associated analytics and quality assurance procedures. The contract is performance-based on a time-and-materials pricing structure with no set-aside designation and is scheduled for completion by September 29, 2027. Performance will be executed at Harvard Pilgrim's Wellesley Hills, Massachusetts location.
Harvard Pilgrim Health Care Inc., a non-profit healthcare research organization and long-standing FDA partner, specializes in post-market medical product safety surveillance and epidemiological research. The organization's Office of Sponsored Programs Division brings extensive expertise in pharmacoepidemiology and health informatics to support the Sentinel System, which is a critical national infrastructure for monitoring the safety of FDA-regulated medical products. This work directly supports the FDA's mission to ensure public health protection through sophisticated data analysis and medical product surveillance mechanisms.
Quick answers
Who was awarded contract 75F40124F19012?
75F40124F19012 was awarded to Harvard Pilgrim Health Care, Inc. by Food and Drug Administration (Department of Health and Human Services) on March 29, 2024.
How much is contract 75F40124F19012 worth?
The government has obligated $9,714,571 on 75F40124F19012.
Is contract 75F40124F19012 an order under another contract?
Yes. 75F40124F19012 is a delivery order under 75F40119D10037, an indefinite delivery contract.
Was contract 75F40124F19012 competed?
The extent of competition for 75F40124F19012 was full and open competition.
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