FAR 13.pdf

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. Supporting rationale demonstrating the unique qualifications of the proposed contractor or the nature of the action requiring the use of the authority.

The USDA APHIS VS CFTEP was developed to eliminate the spread of the cattle fever tick throughout the United States. CFTEP maintains the Permanent Quarantine Zone (PQZ) along the southern Texas border from Del Rio to Brownsville, approximately 500 miles. One of the tools utilized by CFTEP to eliminate fever ticks is ivermectin-medicated molasses tubs. Cattle consume the tubs, which then provides for prevention and eradication of fever ticks within the herd.

A Minimum Use-Major Species Permit was obtained from the FDA for use of this product (I- 011938) following a nine-month field study. On December 18, 2024, the FDA granted Positive Feed, Ltd.’s request for a sponsor fee waiver under the minor use/minor species provision of the Animal Drug User Fee Act (ADUFA) of 2003, as codified as section 740(1)(D) of the Federal Food, Drug and Cosmetic Act Administration (FD&C Act), for FY2025. The tubs are for use only by the CFTEP under the authority of an Investigational New Animal Drug Permit extended to Positive Feeds, Ltd under the FDA Sponsor Fee Waiver# SR3180. Positive Feeds is currently the only company holding an FDA permit to manufacture this product.

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

Positive Feed, Inc. is the only company holding an FDA permit to manufacture Ivermectin-medicated molasses tubs (Reference Waiver # SR3180).

7. A determination by the Contracting Officer that the anticipated cost to the Government will be fair and reasonable.

Fair and reasonable price will be determined by using historical pricing data (pricing information at which the same or similar items have been sold previously) to accurately evaluate the reasonableness of the proposed pricing.

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

Market research will be performed in accordance with FAR part 10. A Sources Sought Notice, #1146850SS, was posted to SAM.gov from February 24th, 2025-March 4th, 2025 and did not result in the identification of other companies capable of performing the requested work.

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

Refer to paragraph 5.

10. A listing of the sources, if any, that expressed a written interest in the acquisition.

Positive Feed, Ltd.

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

The USDA APHIS will continue to perform market research to identify manufacturers with an FDA Sponsor Fee permit for this supply.

Certifications & Approvals

Supporting data which form the basis for and included in this justification are certified accurate and complete.

Troy Trevino Management and Program Analyst

The information contained in this Justification for Other Than Full and Open Competition is certified accurate and complete to the best of my knowledge and belief.

Lisa Draves Contracting Officer

TROY TREVINO Digitally signed by TROY TREVINO Date: 2025.03.18 13:17:20 -05'00'

LISA DRAVES Digitally signed by LISA DRAVES Date: 2025.03.25 11:43:52 -05'00'

Additional Reviews & Approvals

Advocate for competition for the procuring activity (if over $750,000). I have reviewed this justification and find it to be accurate and complete to the best of my knowledge and belief.

Therefore, unless additional approvals are required as prescribed below, as advocate for competition for the procuring activity/MASCO, I hereby approve this justification.

Larry Nelson Procuring Activity Advocate for Competition

LARRY NELSON

Digitally signed by LARRY

NELSON

Date: 2025.03.25 12:38:40 -05'00'