Base period and three (3) option periods, labor hour (LH) type task order to procure regulatory support in the research and documentation of data and information to support the review of abbreviated…

Active Awarded Last action

Contract number
75F40125F19005
Awardee
Awarding agency
Obligated
$519,856

Award facts

Contract value 37% obligated
  • $519,856.38 Current, with exercised options
  • $1,423,410.78 Potential, with all options
Completion date 33% complete
  • Current, with exercised options
  • Potential, with all options
Set-aside
Competitive 8(a)
Competition
Full and Open Competition after exclusion of sources Negotiated Proposal / Quote
Pricing
Labor Hours
Place of performance
Ivins, UT, USA
Legislative mandates

Award details come from SAM.gov/FPDS.

Transactions

Action Obligated Date
Supplemental Agreement for work within scope P00002 · Revise OP1, OP2, OP3 and exercise OP1. Base period and three (3) option periods, labor hour (LH) type task order to procure regulatory support in the research… $351,840
Supplemental Agreement for work within scope P00001 · No cost time extension (all periods). Base period and three (3) option periods, labor hour (LH) type task order to procure regulatory support in the research… $0
Original award $168,017

About this award

The Food and Drug Administration (FDA) awarded a labor hour delivery order valued at $1.42M to Kaiva Strategies, LLC, a tribally-owned, minority-owned small business based in Ivins, Utah. This competitive 8(a) set-aside contract is issued under the FDA's $100M Professional, Administrative, and Consulting Services (PACS) Indefinite Delivery Contract (IDC), which provides flexible mechanisms for the agency to procure specialized regulatory and administrative support services. The task order establishes a base period and three option periods, with an ultimate completion date of April 9, 2029, and was awarded on August 4, 2025. Work will be performed in Ivins, Utah.

Under this delivery order, Kaiva Strategies will provide regulatory support through research and documentation of data and information to assist the FDA's Center for Drug Evaluation and Research in reviewing Abbreviated New Drug Applications (ANDAs). The company's expertise in regulatory support, scientific communication, and medical writing aligns with the FDA's critical mission of ensuring drug safety and efficacy. As a certified 8(a) joint venture and small disadvantaged business, Kaiva Strategies brings substantial experience supporting multiple FDA centers and offices through its existing PACS IDC, having previously delivered services ranging from regulatory review support to administrative assistance across various FDA program areas.

Description

Base period and three (3) option periods, labor hour (LH) type task order to procure regulatory support in the research and documentation of data and information to support the review of abbreviated new drug applications for the FDA's center for

Quick answers

Who was awarded contract 75F40125F19005?

75F40125F19005 was awarded to Kaiva Strategies, LLC by Food and Drug Administration (Department of Health and Human Services) on August 4, 2025.

How much is contract 75F40125F19005 worth?

The government has obligated $519,856 on 75F40125F19005. Its potential value, with all options, is $1,423,411.

Is contract 75F40125F19005 an order under another contract?

Yes. 75F40125F19005 is a delivery order under 75F40123D00021, an indefinite delivery contract.

Was contract 75F40125F19005 competed?

The extent of competition for 75F40125F19005 was full and open competition after exclusion of sources. It was set aside: Competitive 8(a).

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