Attachment 3: Class Justification and Approval

United States Department of Agriculture
Class Justification to Restrict Competition
Identification Number: 1164220
In accordance with the Revolutionary Federal Acquisition Regulation (FAR) 12.102(b), the following justification documents the decision to restrict competition for this acquisition. (1) Mission Area and Contracting Activity.
The contracting activity, USDA, APHIS, Marketing and Regulatory Programs Business Services (MRPBS), Acquisition and Asset Management Division (AAMD), proposes to enter into contracts on the basis of other than full and open competition.
(2) Nature and/or description of the action being approved. This is a Class Justification and Approval (J&A) for the acquisition of specialized diagnostic testing services using other than full and open competition. The Government intends to limit competition to laboratories possessing the unique qualifications, certifications, validated interoperability, and technical capabilities necessary to satisfy the agency’s minimum requirements. These diagnostic testing services are commercial in nature and will be procured in accordance with the procedures prescribed in FAR Part 12.
To ensure effective animal disease diagnosis and surveillance, ongoing access to eligible laboratories is essential. These services enhance U.S. animal agriculture by strengthening national veterinary diagnostic networks for early detection, rapid response, and recovery from high-impact diseases. Demand for these services is driven by unpredictable outbreaks, and APHIS expects continued or increased need compared to past efforts.
Authority to act under this class justification expires on 31 May 2036. (3) A description of the supplies or services required to meet the agency’s needs (including the estimated value).
The laboratories will provide diagnostic testing services for endemic animal diseases of high consequence and foreign animal diseases. The services include conducting a range of approved diagnostic assays for both routine and emergency testing, including during potential bioterrorism events, to ensure the rapid detection, reporting, and confirmation of animal disease occurrences. All samples that test presumptive positive or inconclusive will be submitted to the National Veterinary Services Laboratories (NVSL) for confirmatory testing.
In addition, the laboratories will provide accurate and timely diagnostic data to meet epidemiological and reporting requirements, support responses to foreign animal disease outbreaks and other adverse