FAR 13.5 Brand Name Justification-S.pdf

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United States Department of Agriculture

Sole Source/Brand Name Justification

Exceeding the Simplified Acquisition Threshold

FAR 13.5

Control No. (if applicable) ______________________

1. Identification of the agency and the contracting activity.

Mission Area:

United States Department of Agriculture (USDA)

Animal Plant Health Inspection Service (APHIS)

Veterinary Services (VS)

Cattle Fever Tick

Eradication Program

(CFTEP)

Contracting Activity:

USDA, APHIS, Marketing Regulatory Programs Business Services

Acquisition and Asset Management Division

Procurement Branch

250 Marquette Ave, Suite 410

Minneapolis, MN 55401

2. The nature and/or description of the action being approved.

The USDA intends to issue a competitive solicitation and issue a firm fixed price purchase order for the limited source brand-name product Dectomax (Doramectin).This acquisition will be conducted using the simplified procedures for certain commercial items under Federal Acquisition Regulation

(FAR) Part 13.5.

3. Description of the supplies or services required to meet the agency’s needs (including the estimated value).

The objective of this procurement is to obtain 785 bottles of Doramectin (500ml injectable solution) for the treatment of cattle fever ticks under the auspices of the USDA Cattle Fever Tick Eradication

Program (CFTEP) in Texas.

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. However, there are multiple vendors or distributors of Dectomax.

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The product to be provided under this contract is Dectomax (Doramectin) 500ml injectable solution, 1,500 bottles. Dectomax (Doramectin) is a ready-to-use, colorless to pale yellow, sterile solution containing 1% w/v doramectin (10 mg/mL), manufactured by Zoetis United States.

The estimated effective date of the purchase order is March 15, 2023.

The estimated dollar value of the contract is $150,000.00.

4. The statutory authority permitting other than full and open competition.

The following circumstance justifies the exception to brand name under FAR 13.5:

41 U.S.C § 1901 - Simplified Acquisition Procedures up to $7.5 million, as authorized by FAR

13.500(a) and implemented by FAR 13.501(a).

5. Statement demonstrating the unique qualifications of the proposed contractor or the nature of the action requiring the use of the authority.

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.

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.7

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

6. Description of efforts made to ensure offers are solicited from as many potential sources as is practicable.

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. As noted above, although this is a brand name product, there are multiple vendors that supply this product.

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 brand 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.

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

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In accordance with FAR 5.201, this brand name justification and approval will be posted with the solicitation on the Contract Opportunities website.

7. Description of the market research conducted and the results or a statement of the reason

Market Research was not conducted.

The USDA, APHIS, VS has purchased this product for many years so the agency has historical pricing which can be used in determining price reasonableness. No contract will be issued until the contractor price has been determined to be fair and reasonable.

Market research was conducted to obtain information on potential sources for providing this product.

8. Any other facts supporting the use of other than full and open competition.

No additional supporting facts.

9. Listing of the sources, if any, that expressed a written interest in the acquisition.

No sources have an expressed an interest in the acquisition.

10. Statement of actions, if any, the agency may take to remove or overcome any barriers to competition if subsequent acquisitions are anticipated.

Until other vendors become available that are willing to manufacture this product, the USDA will be required to continue purchasing this brand name product. However, through posting of a competitive solicitation it will perhaps lead to interest from several vendors that supply this product.

11. Determination by the Contracting Officer that the anticipated cost to the Government will be fair and reasonable.

No award will be issued until the price is determined to be fair and reasonable folloiwng a competitive acquisition process.

Certifications & Approvals

☒ The information provided for this justification has been reviewed and certified accurate and complete by Ralph Chavez, Program/Technical Personnel.

Contracting Officer (not exceeding $750,000). I have reviewed this justification and certify it to be accurate and complete to the best of my knowledge and belief.

☒ Approved.

☐ Reviewed and forwarding to the Procuring Activity Advocate (MASCO or Delegate).

Contracting Officer

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Additional Reviews & Approvals

Signatures are required at each threshold up to the total estimated dollar value of the acquisition

Advocate for competition for the procuring activity (MASCO or Delegate approved by HCA for USDA) (if over $750,000, but not exceeding $15 million). I have reviewed this justification and certify it to be accurate and complete to the best of my knowledge and belief.

☐ Approved.

☐ Reviewed and forwarding to the Head of the Procuring Activity/HCA.

Mission Area Advocate for Competition