JA Dectomax 12639520Q0278.pdf

Brand Name Justification and Approval Page 1

BRAND NAME JUSTIFICATION AND APPROVAL

Limited Sources Justification and Approval United States Department of Agriculture (USDA) Animal Plant Health Inspection Services (APHIS)

Veterinary Services (VS)

1. Organization/Line Office:

USDA APHIS 7209 E. Saunders St. Laredo TX 78041

2. Description of Action being approved:

Purchase order for 1,142 bottles of 500ml injectable solution. Dectomax (Doramectin) is a ready-to-use, colorless to pale yellow, sterile solution containing 1% w/v doramectin (10 mg/mL), manufactured by Zoetis.

3. An identification of the statutory authority permitting other than full and open competition.

FAR 11.105 Items Peculiar to One Manufacturer.

4. Identification of the Justification Rationale:

The Cattle Fever Tick Eradication Program (CFTEP) has maintained a Quarantine zone along 600 miles of the Texas-Mexico border since 1938. This quarantine zone has been the key component in the success of the Cattle Fever Tick Eradication Program. Whenever fever ticks are detected on the U.S. side of the border, USDA employees immediately begin to treat all livestock on and around the infested premises. Currently, there are three classes of drugs which are used to treat livestock. Coumaphos, doramectin, and ivermectin. Each of these products has a different mode of action. Which product is utilized on premises is determined by CFTEP Epidemiologists when the Herd Plan is developed.

Doramectin offers a number of advantages, including an extended time interval between treatments, and reduces toxic chemical exposure to USDA staff administering the product. At this time Doramectin is only manufactured by one company in the United States and is sold under the trade name of Dectomax.

This is a brand name request and the contractor must provide the brand name product. In accordance with Texas Administrative Code Part 2, Chapter 41, Section 41.8, Dectomax (Doramectin) is the only authorized applicant to spray, dip or inject livestock for Cattle Fever Tick operations in Texas per Texas Administrative Code Part 2, Chapter 41, Section 41.8.

5. Best Value Determination:

Orders issued under this class limited sources justification represent the best value available as the agreed to prices will be based upon competitive quotes received from authorized retailers of the product in a competitive environment. Therefore, the price paid will represent the best value and result in the lowest overall cost alternative to meet the needs of USDA.

6. Market Research Conducted:

Currently there are three classes of drugs which are used to treat livestock. Coumaphos, doramectin, and ivermectin. Each of these products has a different mode of action. Which product is utilized on premises is determined by CFTEP Epidemiologists, in accordance with Texas Administrative Code Part 2, Chapter 41, Section 41.8, when the Herd Plan is developed.

Brand Name Justification and Approval Page 2

7. Statement of Actions, if any, to remove barriers to competition in the future:

At this time, due to the state legal limitation placed on VS by Texas Administrative Code Part 2, Chapter 41, Section 41.8 to use this specific product, we are unable to identify any potential removal of competition barriers. However, if another manufacturer of doramectin is found that produces the compound in accordance with Texas Law, an application to the state can be submitted to request inclusion of the manufacture’s product to the authorized state treatment listing

8. Any other facts supporting justification:

In accordance with Texas Administrative Code Part 2, Chapter 41, Section 41.8, Dormectin is the only authorized applicant to spray, dip or inject livestock for Cattle Fever Tick operations in Texas.

Texas Administrative Code Part 2, Chapter 41, Section 41.8 is attached.

The full Texas Administrative Code can be accessed at:

http://texreg.sos.state.tx.us/public/readtac$ext.ViewTAC?tac_view=3&ti=4&pt=2

As the technical or requirement personnel, I certify that the evidence of the supporting data that forms the basis of this justification is complete and accurate.

Miguel A. Benavides 7/16/20 Technical/Requirements Personnel Printed Name Date

Contracting Officer Date

MIGUEL

BENAVIDES

0.9.2342.19200300.100.1.1=12001003376962 Date: 2020.07.16 15:18:23 -05'00' http://texreg.sos.state.tx.us/public/readtac%24ext.ViewTAC?tac_view=3&ti=4&pt=2