A05_JA for Under SAT 12639526Q0229 DPP VetTB Assay-redacted.pdf

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

Identification Number: 12639526Q0229

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: 1175631

Requesting Activity Agency:

USDA APHIS VS NVSL DBRL

1920 Dayton Avenue Ames IA 50010

Contracting Activity:

USDA APHIS MRPBS AAMD

250 Marquette Ave., Suite 410 Minneapolis, Minnesota 55401

(2) Estimated Value

(3) Brief Description of Supplies or Services

The acquisition involves procuring Dual Path Platform (DPP) Vet Tuberculosis (TB) Assay kits. These are single use immune-chromatographic tests for detection of antibodies to Mycobacterium Bovis in cervid samples and is the official test for the Federal Bovine Tuberculosis Eradication program. The test is used for the diagnosis of tuberculosis in conjunction with other diagnostic methods. quantitative analysis.

(4) Suggested Source

The suggested contractor is:

Chembio Diagnostic Systems, Inc.

3661 Horseblock Road, Medford, NY 11763

UEI: Z4B4JJDLQNK9

(5) 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.

Identification of Statutory Authority. FAR 6.302-1, Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements, 41 U.S.C. 253 (c) (1). Bovine tuberculosis is a contagious and infectious granulomatous disease caused by the bacterium Mycobacterium bovis. Although commonly defined as a chronic debilitating disease, bovine tuberculosis can occasionally assume an acute, rapidly progressive course. While any body tissue can be affected, lesions are most frequently observed in the lymph nodes, lungs, intestines, liver, spleen, pleura, and peritoneum. Although cattle are considered to be the true hosts of M. bovis, the disease has been reported in several other species of livestock, most notably bison and captive cervids. There have also been instances of infection in other domestic and nondomestic animals, as well as in humans.

Through the National Cooperative State/Federal Bovine Tuberculosis Eradication Program, the Animal and Plant Health Inspection Service (APHIS) of the United States Department of Agriculture (USDA) works cooperatively with the Nation's livestock industry and State animal health agencies to eradicate bovine tuberculosis from domestic livestock in the United States and prevent its recurrence.

Federal regulations implementing this program are contained in 9 CFR part 77, “Tuberculosis” (referred to below as the regulations) and in the “Uniform Methods and Rules—Bovine Tuberculosis Eradication,” which is incorporated by reference within the regulations. The regulations restrict the interstate movement of cattle, bison, and captive cervids to prevent the spread of bovine tuberculosis. Subpart C of the regulations (§§ 77.20 to 77.41, referred to below as the captive cervid regulations) addresses captive cervids.

Currently, in the captive cervid regulations, there are several instances in which we require captive cervids to be tested with an official tuberculosis test. For example, in § 77.35, in order for a herd of captive cervids to be recognized as accredited, all cervids in the herd must have tested negative to at least two consecutive official tuberculosis tests, conducted at 9-to-15-month intervals, with certain, limited exceptions.

In § 77.20 of the captive cervid regulations, prior to issuance of this interim rule, the definition of official tuberculosis test listed the following as official tests for bovine tuberculosis in captive cervids:

The single cervical tuberculin (SCT) test, a primary test.

• The comparative cervical tuberculin test (CCT) test, a supplemental test.

• The CervidTB Stat-Pak® test, a primary test. (discontinued)

• The Dual Path Platform (DPP®) test, a primary and supplemental test.

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

Market Research performed by the Contract Specialist and technical group did not identify any other sources currently able to meet the requirements. Previous contract history was analyzed, and internet sources used in making the determination that only one source for DPP cervid tests. A notification of the Agency’s intent to negotiate a sole source contract with Chembio will be publicized on SAM.gov to notify interested parties and encourage private development of other TB cervid tests. The synopsis of the pending action will include information as to how interested parties may submit products and information for review and consideration.

Prior to the approval of DPP test being the official test, the SCT and CCT tests were official tuberculosis tests for all species of captive cervids in a final rule published in the Federal Register on December 31, 1998 (63 FR 72104-72129, Docket No. 92-076-2 The CervidTB DPP® tests were announced as the official tuberculosis tests for captive elk, red deer, white-tailed deer, fallow deer, and reindeer in an interim rule published in the Federal Register on January 9, 2013 (78 FR 1718- 1723, Docket No. APHIS-2012-0087).

Certifications & Approvals

(6) 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.

Date Section Head, Serology

(7) 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.

Date Contracting Officer