New SOW for regulatory activities for pcca and mmab gene therapy products

Active Awarded Last action

Contract number
75N95025F00001
Awardee
Awarding agency
Obligated
$230,617

Award facts

Opportunity
  • 75N95025R00023 Solicitation number
Contract value 42% obligated
  • $230,616.68 Current, with exercised options
  • $545,690.33 Potential, with all options
Completion date 48% complete
Current and potential, with all options
Funding agency
National Center for Advancing Translational Sciences National Institutes of Health, Department of Health and Human Services
Set-aside
Total Small Business
Competition
Full and Open Competition after exclusion of sources · 3 offers Multiple Award, Fair Opportunity
Pricing
Labor Hours
Place of performance
San Jose, CA 95131, USA
Legislative mandates

Award details come from SAM.gov/FPDS.

Transactions

Action Obligated Date
Exercise an Option P00001 · Exercise option b for regulatory activities for pcca and mmab gene therapy products $44,788
Original award $185,829

About this award

The National Center for Advancing Translational Sciences issued a delivery order to CCS Associates, Inc., a woman-owned small business, on May 21, 2025, with a ceiling value of $545,690.33 under a Total Small Business set-aside for regulatory activities supporting PCCA and MMAB gene therapy products.

Place of performance is San Jose, CA. The order exercises Option B and carries an ultimate completion date of May 20, 2028. Work is priced on a labor-hours basis and includes a new statement of work for regulatory activities in addition to the option exercise. CCS Associates specializes in regulatory affairs and scientific consulting for biomedical and pharmaceutical research, with prior work across NIH institutes and the FDA focused on regulatory document preparation, clinical trial management, and IND application support.

Quick answers

Who was awarded contract 75N95025F00001?

75N95025F00001 was awarded to CCS Associates, Inc. by National Institute on Drug Abuse (National Institutes of Health) on May 21, 2025.

How much is contract 75N95025F00001 worth?

The government has obligated $230,617 on 75N95025F00001. Its potential value, with all options, is $545,690.

Which agency awarded contract 75N95025F00001?

National Institute on Drug Abuse (National Institutes of Health) awarded 75N95025F00001, with funding from National Center for Advancing Translational Sciences (National Institutes of Health).

Is contract 75N95025F00001 an order under another contract?

Yes. 75N95025F00001 is a delivery order under 75N95022D00013, an indefinite delivery contract.

Was contract 75N95025F00001 competed?

The extent of competition for 75N95025F00001 was full and open competition after exclusion of sources. The government received 3 offers. It was set aside: Total Small Business.

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