Firm fixed award center for devices and radiological health (cdrh)- premarket/postmarket tracking services FDA three-way-matching invoice clause-COR

Ended Awarded Last action

Contract number
75F40120F19001
Awardee
Awarding agency
Obligated
$13,740,190

Award facts

Contract value 100% obligated
  • $13,740,190.01 Current, with exercised options
  • $13,743,348.51 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 after exclusion of sources Negotiated Proposal / Quote
Pricing
Firm Fixed Price
Place of performance
Rockville, MD 20857, USA

Award details come from SAM.gov/FPDS.

Transactions

Action Obligated Date
Other Administrative Action P00015 $0
Other Administrative Action P00014 · COR change $0
Other Administrative Action P00013 $0
Other Administrative Action P00012 $19,603
Exercise an Option P00011 $3,018,620
Other Administrative Action P00010 $579,894
Exercise an Option P00009 $2,352,453
Other Administrative Action P00008 $0
Other Administrative Action P00007 $92,141
Other Administrative Action P00006 $0
Exercise an Option P00005 $2,715,147
Other Administrative Action P00004 $0
Exercise an Option P00003 $2,683,655
Other Administrative Action P00002 $8,602
Other Administrative Action P00001 $0
Original award $2,270,077
Show all 16

About this award

This delivery order, awarded on September 18, 2020, is part of a larger $103 million Indefinite Delivery Contract between the Food and Drug Administration (FDA) and Pn-Heitech, LLC, a minority-owned small business based in Baltimore, Maryland. The contract has a ceiling value of approximately $13.7 million and supports the Center for Devices and Radiological Health (CDRH) premarket and postmarket tracking services. The work will be performed in Rockville, Maryland, with an ultimate completion date of September 29, 2025. This is a firm fixed-price delivery order with no set-aside designation, and the contract was awarded in accordance with the contractor's proposal and procurement regulations.

Pn-Heitech specializes in providing comprehensive information technology, regulatory support, and administrative services to federal agencies. Under this delivery order, the company will deliver premarket and postmarket device tracking services for the FDA's CDRH, supporting the agency's oversight of medical devices and radiological health products. Pn-Heitech's broader portfolio of services to the FDA includes help desk support, Freedom of Information Act program assistance, medical device registration and listing, adverse event data management, and records management. The contract was overseen by multiple FDA representatives, including the Contracting Officer's Representative David McClintock and Lisa M. King, with James G. Whitt serving as the Contracting Officer.

Quick answers

Who was awarded contract 75F40120F19001?

75F40120F19001 was awarded to Pn-Heitech, LLC by Food and Drug Administration (Department of Health and Human Services) on September 18, 2020.

How much is contract 75F40120F19001 worth?

The government has obligated $13,740,190 on 75F40120F19001. Its potential value, with all options, is $13,743,349.

Is contract 75F40120F19001 an order under another contract?

Yes. 75F40120F19001 is a delivery order under 75F40120D00020, an indefinite delivery contract.

Was contract 75F40120F19001 competed?

The extent of competition for 75F40120F19001 was full and open competition after exclusion of sources.

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