No cost modification to change the period of performance end date for clin 2 to september 29, 2026.

Ended Awarded Last action

Contract number
75F40124F19014
Awardee
Awarding agency
Obligated
$365,500

Award facts

Contract value 1% obligated
$25,692,680.00 Current and potential, with all options
Completion date 100% complete
Current and potential, with all options
Contracting staff
Set-aside
No set-aside
Competition
Full and Open Competition Negotiated Proposal / Quote
Pricing
Firm Fixed Price
Place of performance
Wellesley Hills, Wellesley, MA 02481, USA
Legislative mandates

Award details come from SAM.gov/FPDS.

Transactions

Action Obligated Date
Supplemental Agreement for work within scope P00002 · Sentinel system extension of services for 1) aria system, 2) RWE claims-EHR linked data, 3) program/project management, 4) follow on to the pdufa VII assessment… $365,500
Other Administrative Action P00001 $0
Original award Sentinel system extension of services for 1) aria system, 2) RWE claims-EHR linked data, 3) program/project management, 4) follow on to the pdufa VII assessment… $25,327,180

About this award

Harvard Pilgrim Health Care Inc. has been awarded a no-cost modification to a delivery order contract with the Food and Drug Administration (FDA) extending the period of performance for CLIN 2 through September 29, 2026. The contract, valued at $25.7 million on a firm fixed-price basis, supports continuation of the FDA's Sentinel System, a critical post-market medical product safety surveillance program. Services include operations and maintenance of the ARIA System, management of real-world evidence claims and electronic health record linked data, program and project management, follow-on assessments related to the Prescription Drug User Fee Act VII, website operations and maintenance, training, and the annual Sentinel System workshop. The work will be performed in Wellesley Hills, Massachusetts, with no set-aside designation applied to this award.

The modification reflects the FDA's ongoing reliance on Harvard Pilgrim Health Care Inc.'s specialized expertise in pharmacoepidemiology, health informatics, and surveillance data analytics to support the Sentinel System's essential mission. As a non-profit healthcare research organization, Harvard Pilgrim brings substantial capabilities in epidemiological research and public health data management, having established itself as a key federal partner through previous contracts with the FDA and Centers for Disease Control and Prevention. This delivery order extension ensures continuity of critical safety surveillance infrastructure that supports post-market monitoring of drugs, biologics, and medical devices across the United States healthcare system.

Quick answers

Who was awarded contract 75F40124F19014?

75F40124F19014 was awarded to Harvard Pilgrim Health Care, Inc. by Food and Drug Administration (Department of Health and Human Services) on September 20, 2024.

How much is contract 75F40124F19014 worth?

The government has obligated $365,500 on 75F40124F19014. Its current value, with exercised options, is $25,692,680.

Is contract 75F40124F19014 an order under another contract?

Yes. 75F40124F19014 is a delivery order under 75F40119D10037, an indefinite delivery contract.

Was contract 75F40124F19014 competed?

The extent of competition for 75F40124F19014 was full and open competition.

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