Regulatory review support services

Ended Awarded Last action

Contract number
75F40121F19019
Awardee
Awarding agency
Obligated
$5,032,844

Award facts

Contract value 93% obligated
$5,438,456.93 Current and potential, with all options
Completion date 100% complete
Current and potential, with all options
Competition
Full and Open Competition · 2 offers Multiple Award, Fair Opportunity
Pricing
Firm Fixed Price
Place of performance
Silver Spring, MD 20993, USA

Award details come from SAM.gov/FPDS.

Transactions

Action Obligated Date
Close Out P00007 -$0
Exercise an Option P00006 $0
Exercise an Option P00005 · Option period 3 exercise $1,611,226
Exercise an Option P00004 · Option period 2 exercise $1,700,000
Other Administrative Action P00003 · IPP modification $0
Other Administrative Action P00002 $0
Exercise an Option P00001 $574,994
Original award $1,146,624

About this award

The FDA issued a BPA call to IBM under the Regulatory Review Support Services parent BPA on June 28, 2021, with a ceiling value of $5,438,456.93. The Regulatory Review Support Services BPA, awarded to IBM, supports the FDA's regulatory review and analysis functions including clinical services, data management, and submission processing.

Work is performed in Silver Spring, Maryland. The call's ultimate completion date is February 5, 2026. Delivery includes regulatory review support services spanning OCS analysis studio toolbox support, clinical service support, data management and analysis, and tobacco product submission services.

Service Contract Inventory reporting shows the call's actual labor footprint across four fiscal years. FY2024 (the most recent reported year) reflects 4.0 FTEs and 8,351 contractor hours, with one subcontractor performing 27% of the hours. Invoiced amounts grew from $84 thousand in FY2021 to $1.2 million in FY2022, declined to $762 thousand in FY2023, and recovered to $1.1 million in FY2024. Derived government-paid hourly rates trended downward overall, from $210.31/hour in FY2022 to $127.68/hour in FY2024.

Quick answers

Who was awarded contract 75F40121F19019?

75F40121F19019 was awarded to International Business Machines Corporation by Food and Drug Administration (Department of Health and Human Services) on June 28, 2021.

How much is contract 75F40121F19019 worth?

The government has obligated $5,032,844 on 75F40121F19019. Its current value, with exercised options, is $5,438,457.

Is contract 75F40121F19019 an order under another contract?

Yes. 75F40121F19019 is a BPA call under GS35F110DA-75F40119A10019, a blanket purchase agreement, on Regulatory Review Support Services.

Was contract 75F40121F19019 competed?

The extent of competition for 75F40121F19019 was full and open competition. The government received 2 offers.

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