Sole Source Justification - BM86 Immunomodulator Vials.pdf

United States Department of Agriculture Decision to Restrict Competition under the Simplified Acquisition Threshold

Identification Number:

Rev. 10/29/25

In accordance with the Revolutionary Federal Acquisition Regulation (FAR) Overhaul (RFO) FAR

12.102 (a), the following documents the decision to restrict competition for this acquisition.

(1) Mission Area and Contracting Activity.

Requisition Number: 1164965

Requesting Activity Agency:

United States Department of Agriculture (USDA) Animal Plant Health Inspection Service (APHIS) Veterinary Services (VS) Troy Trevino Management and Program Analyst

Contracting Activity:

USDA APHIS

Animal and Plant Inspection Service 250 Marquette Ave., Suite 410 Minneapolis, Minnesota 55401

(2) Brief Description of Supplies or Services

CFTEP uses the BM86 vaccine immunomodulator as a critical piece of integrated pest management for eradicating Cattle Fever Tick in fever tick infested areas of South Texas. Cattle are vaccinated with this product wherever USDA CFTEP veterinary epidemiologists determine there is an elevated risk for incursion of Cattle Fever Tick infestations. CFTEP requires 14,000 doses of the BM86 vaccine to meet its annual cattle vaccination requirements. Due to the vendor’s minimum 6-month production lead time to assemble the product ingredients, produce and blend the vaccine, and perform quality control checks, the earliest anticipated delivery date would be 01 September 2026.

(3) Suggested Source

Zoetis, Inc.

333 Portage Street Kalamazoo, MI 49007

UEI: 1104242461

(4) Justification for Restricting Competition and the Basis for that Decision.

A. Explain the unique qualifications/characteristics of the proposed contractor or product and why no other contractor or product/service can meet the Government's need.

United States Department of Agriculture Decision to Restrict Competition under the Simplified Acquisition Threshold

Identification Number:

Rev. 10/29/25

BM86 Immunomodulator is an experimental veterinary biological product developed by USDA ARS, manufactured by Zoetis, Inc., and approved for use in the United States by the applicable regulatory body (USDA APHIS CVB). The vendor, Zoetis, Inc., has exclusive property rights to this product and no alternatives are available to meet USDA requirements.

B. Describe market research conducted and the results or the reason why no market research was conducted.

BM86 Immunomodulator is an experimental product. No other approved vaccines are available within the United States. The product is made soley by Zoetis, Inc., for use within USDA APHIS VS for fever tick eradication. USDA has already had successful experience demonstrating the safety and efficacy with previous lots of this vaccine.

Certifications & Approvals

(5) Technical / Requirements Personnel Certification I certify this requirement meets the Government’s minimum need and that the supporting data, which forms a basis for this justification, is complete and accurate.

Troy Trevino Date Management/Program Analyst

(6) Contracting Officer’s Certification I certify that the data supporting the recommended use of other than full and open competition accurate and complete to the best of my knowledge and belief. I hereby approve this justification.

Name Date Contracting Officer

TROY TREVINO Digitally signed by TROY TREVINO Date: 2026.02.11 15:54:20 -06'00'