Improvements in pharmaceutical quality chemistry manufacturing and control (PQ CMC) data standards for regulatory submissions and analysis

Ended Awarded Last action

Contract number
75F40121F19024
Awardee
Awarding agency
Obligated
$6,078,383

Award facts

Contract value 75% obligated
  • $6,078,382.98 Current, with exercised options
  • $8,106,307.14 Potential, with all options
Completion date 100% complete
Current and potential, with all options
Set-aside
No set-aside
Competition
Full and Open Competition · 1 offer Multiple Award, Fair Opportunity
Pricing
Firm Fixed Price
Place of performance
Silver Spring, MD 20993, USA
Legislative mandates

Award details come from SAM.gov/FPDS.

Transactions

Action Obligated Date
Other Administrative Action P00008 · To correct P00006 period of performance and total obligated amount. $0
Other Administrative Action P00007 $0
Exercise an Option P00006 · The purposes of this modification are to exercise option period 2 and add supplemental work within scope to the SOW. $2,627,924
Other Administrative Action P00005 $0
Other Administrative Action P00004 $0
Other Administrative Action P00003 $0
Other Administrative Action P00002 $1,499,889
Other Administrative Action P00001 $0
Original award $1,950,569

About this award

This is a firm fixed price contract awarded by the Food and Drug Administration (FDA) to International Business Machines Corporation (IBM) for "Improvements in Pharmaceutical Quality Chemistry Manufacturing and Control (PQ CMC) Data Standards for Regulatory Submissions and Analysis". The award, valued at $8,106,307.14, is a Blanket Purchase Agreement (BPA) call under the Regulatory Review Support Services master BPA.

The contract does not have a set-aside designation. IBM has subcontracted portions of the work to small, minority-owned businesses such as Eclaro International Inc., Samvit Solutions LLC, Callideo, Inc., and Vector Consulting, Inc. to provide computer programming and IT services in support of the FDA's pharmaceutical data standards initiative. This aligns with the FDA's mission to ensure the safety, effectiveness, and quality of drugs and pharmaceutical products.

Subawards

Subcontractor Amount Awarded
Samvit Solutions LLC TO CORRECT P00006 PERIOD OF PERFORMANCE AND TOTAL OBLIGATED AMOUNT. Computer Programmers $689,588

Quick answers

Who was awarded contract 75F40121F19024?

75F40121F19024 was awarded to International Business Machines Corporation by Food and Drug Administration (Department of Health and Human Services) on September 16, 2021.

How much is contract 75F40121F19024 worth?

The government has obligated $6,078,383 on 75F40121F19024. Its potential value, with all options, is $8,106,307.

Is contract 75F40121F19024 an order under another contract?

Yes. 75F40121F19024 is a BPA call under GS35F110DA-75F40119A10019, a blanket purchase agreement, on Regulatory Review Support Services.

Was contract 75F40121F19024 competed?

The extent of competition for 75F40121F19024 was full and open competition. The government received 1 offer.

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