Single Source Colorado Serum Company-DS.pdf

United States Department of Agriculture Limited Source/Brand Name Justification

FAR 13.106-1(b)(1) – Simplified Acquisitions Control No. (if applicable) ______________________

1. Identification of the agency and the contracting activity.

Agency:

National Veterinary Services Laboratories Brucella and Mycobacterium Reagents Team c/o Teresa M. Sigafoose 1920 Dayton Road Ames, Iowa 50010

Contracting:

Procurement Branch Acquisition and Asset Management Division

USDA, APHIS, MRPBS

250 Marquette Ave, Suite 410 Minneapolis, MN 55401

2. Description of supply or service required to meet the agency’s needs.

Mycobacterium bovis Bulk Purified Protein Derivative (PPD) Tuberculin. Product used to make the Comparative Cervical PPD Tuberculin and the Single Cervical PPD Tuberculin used by Veterinarians in the United States (US) to test for Bovine Tuberculosis according to the Bovine TB Eradication Uniform Methods and Rules https://www.aphis.usda.gov/animal_health/animal_diseases/tuberculosis/downloads/tb-umr.pdf

The National Tuberculosis Eradication Program The National Tuberculosis Eradication Program, which is administered by the U.S. Department of Agriculture's (USDA) Animal and Plant Health Inspection Service (APHIS), State animal health agencies, and U.S. livestock producers, has nearly eradicated bovine TB from the Nation's livestock population since the program's inception in 1917. The presence of bovine TB in humans has also been reduced as a result of several factors, including the eradication program and pasteurization of milk.

Many consider this one of the great animal and public health achievements in the United States;

however animal health officials continue to detect TB sporadically in livestock herds.

https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/animal-disease-information/cattle-disease-information/national-tuberculosis-eradication-program

3. The rationale or circumstances for limiting competition.

The PPD Tuberculin specified herein is required by the U.S. Department of Agriculture (USDA), Animal and Plant Health Inspection Service (APHIS), National Veterinary Services Laboratories (NVSL), Ames, Iowa, for use in determining whether animals are infected with bovine tuberculosis.

The Mycobacterium bovis Purified Protein Derivative Tuberculin (Tuberculin, PPD, BOVIS, hereinafter referred to as PPD Tuberculin), must be of current production. In order to meet program requirements, the delivery requirements specified must be met. It is highly important that the PPD Tuberculin possess https://www.aphis.usda.gov/animal_health/animal_diseases/tuberculosis/downloads/tb-umr.pdf https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/animal-disease-information/cattle-disease-information/national-tuberculosis-eradication-program https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/animal-disease-information/cattle-disease-information/national-tuberculosis-eradication-program the maximum uniformity possible from the standpoint of specificity and potency. Therefore, exacting compliance with uniform methods and materials in preparing, storing, diluting, testing, bottling, and shipping is essential. Only facilities that are licensed and/or inspected and approved by the USDA for production of PPD Tuberculin shall be used. Colorado Serum Company is the only licensed manufacturer in the US.

4. A description of the market research conducted and the results or a statement of the reason market research was not conducted.

As listed in “Veterinary Biological Products, Licensees and Permittees. Prepared February 2, 2023”,Colorado Serum Company is the only vendor Tuberculin to be acquired for the purpose of this research. This catalog can be accessed via the website below and is also maintained in the contract file.

This serum from Colorado Serum Company is necessary to the mission critical nature of the research that is being conducted. Under USDA Veterinary Services mission critical parameters Colorado Serum Company is the only licensed (#188) vendor for Mycobacterium bovis. The use of any other vendors Tuberculin without proper vetting and licensure could lead to mission failure.

Licensed Veterinary Biological Product Information

5. Estimated price, including all options, if applicable.

Mycobacterium bovis pricing is based on mg/ml. The cost is $1.10 mg/ml. The bulk Mycobacterium bovis PPD has a protein concentration of 11.6 mg/ml. A total of 2000 mls is requested. Cost is $25,520.00.

6. Recommended source(s).

Colorado Serum Company https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/veterinary-biologics/ct_vb_licensed_products

Certifications

Supporting data that is the responsibility of technical or requirements personnel and which form the basis for this justification are accurate and complete to the best of my knowledge.

Teresa M. Sigafoose Section Head, Microbiologist

National Veterinary Services Laboratories

The information contained in this justification is accurate and complete to the best of my knowledge and belief and in accordance with Federal Acquisition Regulation 13.106-1(b)(1), I hereby determine the circumstances described above deem only one source, or limited sources, reasonably available and competition is precluded for the reasons indicated in this document.

Mario Garcia Contracting Officer