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AWARDDEFINITIVE CONTRACTSmall business

Definitive contract 75F40124C00053KAIVA STRATEGIES, LLC

Overview

Award facts

Net obligations
$1.95M
$1,945,474of $1.95M potential value
Outlays (paid to date)
$625.71K
$625.71K paid of $1.95M obligated$625,706
Period of performance
May 6, 2024 to May 12, 2027
Ends in 6 months
Modifications
2
Latest action Mar 25, 2026
Contract type
Definitive contract
PIID 75F40124C00053

Contract value is the most the government could spend; obligations are what it has legally committed; outlays are what it has actually paid.

Description of requirement

TO PROVIDE THE CDRH?S OFFICE OF THE CENTER DIRECTOR (OCD) AND THE CVM WITH THE PROFESSIONAL SUPPORT SERVICES OF A SME IX TO PROVIDE SUPPORT RELATED TO THE MDUFA, ADUFA, AND AGDUFA. THE SME IX SHALL SUPPORT THE EXISTING USER FEE ACTS AND ASSIST FDA LE

Dates and value

Award date
Signed on May 6, 2024
Potential end of performance
May 11, 2027
Current value
$1,945,474Base and exercised options
Potential value (if all options are exercised)
$1,945,474

Obligations by fiscal year of action

  • FY2026: $667,751
  • FY2025: $648,303
  • FY2024: $629,420

Total across 3 fiscal years: $1,945,474

Source: Federal Procurement Data System contract actions as published by SAM.gov and USAspending.gov; latest action recorded Mar 25, 2026. View on USAspending · Recipient on SAM.gov

Recipient

NameKAIVA STRATEGIES, LLC
LocationIVINS, UT
UEIHCWKVFGBPA64
CAGE code99AZ4
Business sizeSmall businessSize at award, per the contracting officer
Parent companyKAIVA STRATEGIES, LLC

Business types and certifications

Minority-ownedSelf-certified small disadvantaged business8(a) joint ventureTribally owned firmFor-profit organizationLimited liability company

Self-reported at the time of the action.

Agency and place

Awarding and funding

Awarded by
  1. Department of Health and Human Services
  2. Food And Drug Administration
  3. FDA OFFICE OF ACQ GRANT SVCS
Funded by
  1. Department of Health and Human Services
  2. Food And Drug Administration
  3. FDA OFFICE OF ACQ GRANT SVCS
Funded from
Devices and radiological health; Fda user fees (non general fund)Program activities075-0600Federal accounts (agency financial reports)

Place of performance

Place of performance
Ivins, Washington County, Utah 84738-6618
Congressional district (place of performance)
UT-02As reported at the time of the action

Classification and competition

Classification

NAICS
541611ADMINISTRATIVE MANAGEMENT AND GENERAL MANAGEMENT CONSULTING SERVICES
Product or service (PSC)
R499SUPPORT- PROFESSIONAL: OTHER (service)

Competition

Extent competed
Not available for competitionB
Reason not competed
Authorized by statute (FAR 6.302-5(A)(2)(I))OTH
Solicitation procedures
Only one sourceSSS
Set-aside
8(a) sole source8AN
Contract pricing
Labor hoursZ
Offers received
1

Contract details

Subcontracting plan
Plan not requiredB
Cost Accounting Standards clause
Not applicable exempt from CASX
Certified cost or pricing data
No
Service Contract Act labor standards
No
Commercial procedures
Commercial products/services procedures not usedD
Government-furnished property
Transaction does not use GFE/GFPN
Bundled requirement
Not bundledH
Consolidated requirement
Not consolidatedD
Undefinitized action (terms not final)
No
Multi-year contract
No
Performance-based service acquisition
Yes - service where PBA is used.Y

Transaction history

Modification history

Base award
May 6, 2024Base obligation at award: $629,420
Latest action
Mar 25, 2026 — Option exercisedModification P00002; obligation change +$667,751
Latest substantive action
Mar 25, 2026 — Option exercisedModification P00002; obligation change +$667,751
Actions by type
  • Base award1
  • Option exercised2
3 actions recorded, May 6, 2024 to Mar 25, 2026; each action counted once.

All contract data

All contract data

Every other field reported for this award, as of its latest reported action

Competition

Evaluation preference
No preference used
Local area set-aside
No
Synopsized publicly (SAM.gov / FedBizOpps)
No
Simplified procedures for commercial items
No

Pricing and financing

Paid by purchase card
No
Latest action: change in base and exercised options
$667,751

Socio-economic and policy

Inherently governmental functions
Other functionsOT
Recovered materials and sustainability
No clauses included and no sustainability includedC
EPA-designated product
Not requiredE
Clinger-Cohen Act planning (IT)
No
Walsh-Healey Act (materials and supplies)
No
Construction wage rates (Davis-Bacon)
No

Place and origin

Domestic or foreign entity
U.S. owned businessA
Country of product or service origin
United statesUSA
Place of manufacture
Not a manufactured end productC

Structure

Award or IDV
Award
Award type
Definitive contractD
Awarding agency code
7500
Awarding sub-tier code
7524
Contracting office code
75F401
Transactions recorded under this award key
3

Funding

Funding agency code
7500
Funding sub-tier code
7524
Funding office code
75F401
Treasury accounts
  • 075-2025/2025-0600-000
  • 075-X-0600-000
Object classes
  • 25.2: Other services from non-Federal sources
Disaster or emergency funding (DEFC)
  • Q: Not Designated Nonemergency/Emergency/Disaster/Wildfire Suppression