A5 Sole source JOFOC.pdf

United States Department of Agriculture Justification for Other than Full and Open Competition

1. Identification of the agency and the contracting activity.

1a. Requesting Activity Agency:

USDA APHIS VS NVS Warehouse 3500 East 149th ST, SUITE 300 Kansas City, MO 64147

1b. Contracting Activity:

USDA, APHIS, MRPBS, AAMD

Minneapolis Procurement Branch 250 Marquette Ave., Suite 200 Minneapolis, MN55401

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

Purchase of Dectomax CA-1 for the treatment and prevention of New World Screwworm in cattle The USDA proposes to enter a brand name, sole source firm fixed price IDIQ contract with Zoetis for Dectomax CA-1 using simplified procedures for certain commercial items under Federal Acquisition Regulation (FAR) Part 6.103-1.

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

As outlined in her 5-pronged plan in June 2025, the Secretary has prioritized U.S. readiness for a potential NWS incursion because of the risk it poses to animal and public health and to the U.S.

economy. Because it is a foreign animal disease, the U.S. has limited safe, effective and approved treatment options to prevent and treat NWS myiasis in animals. Dectomax CA-1 been conditionally approved by the FDA as the only injectable prevention and treatment of NWS larval infestations (myiasis) in cattle. It is “conditionally approved,” meaning it is intended to prevent and treat a serious or life-threatening disease, addresses an unmet animal health need, and demonstrating effectiveness of the drug would require complex or particularly difficult studies that could take months or years to complete.

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

The statutory authority permitting other than full and open competition is 10 U.S.C. 2304(c) (1) as implemented by FAR 6.103-1 Only one responsible source.

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

Because of the deadly animal and public health threat of NWS south of the border, the Secretary of Agriculture has prioritized preparing for a potential NWS outbreak in the U.S., as outlined in her 5-pronged plan in June 2025. It is a foreign animal disease, but the U.S. has limited safe and effective treatment options to prevent and treat NWS in livestock. Dectomax-CA1 is eligible for FDA conditional approval because it is intended to prevent and treat serious or life-threatening NWS myiasis in cattle, addresses an unmet animal health need, and demonstrating effectiveness of the drug would require complex or particularly difficult studies that could take months or years.

Zoetis is the only known manufacturer of Dectomax CA-1, which is the only FDA conditionally approved injectable product for cattle.

Two of the Secretary’s points in the plan were to 1) remove any regulatory hurdles by working with EPA, FDA and others to ensure access to effective wound and treatment products that fall under their jurisdiction, and 2) ensure we (USDA) have sufficient treatments by stockpiling these as a backstop for states as commercial developments accelerate. The HHS Secretary declared NWS a public health emergency, thereby expediting the ability for FDA to offer approval/conditional approval to products by veterinary drug manufacturers in a shortened timeframe. While there are products authorized under the Emergency Use Authorization from FDA, they will require veterinary intervention to administer those off label to an animal. Given the shortage of large animal veterinarians nationwide, this could hamper the prevention and treatment of animals around the country. Because Dectomax CA-1 from Zoetis has received conditional approval from FDA, producers will be able to administer the product without a veterinarian and in compliance with labeling instructions. This will drive up the demand for this product in at risk states, potentially leading to shortages. Additionally, this labelled product (CA-1), is not yet commercially available to the public. Zoetis is in the process of re-labelling the product, but USDA has an opportunity to purchase this product before it is commercially available. This makes this request one of unusual and compelling urgency since there is a bona fide need for the product, precluding full and open competition. Zoetis is the only manufacturer of this product.

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

Zoetis is the only company in the U.S. that offers this product, and it is not commercially available yet to distributors, thus, they are currently the only source of Dectomax CA-1. Additional or similar requirements may be anticipated in the future.

If one searches “Dectomax” in a browser, that will show that it is carried by many vendors. The difference is that for cattle producers to be able to acquire and use this drug without a prescription from a veterinarian, they must use the product labelled with “CA-1,” otherwise it would be under extra label usage. Using this labelled product will increase the number of animals that can be legally treated without a veterinarian, reducing the amount of NWS infested animals.

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

Market research and a review of historical purchases of the commercially available version of Dectomax is comparable to the anticipated Dectomax CA-1 product price. No award will be issued until the price is determined to be fair and reasonable.

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

The NVS has held regular meetings with the Center for Veterinary Medicine in the FDA to stay abreast of the approval status of numerous potential preventions and treatments for NWS myiasis to add to the stockpile. No other injectable macrocytic lactone medication has been conditionally approved for use in cattle by the FDA for this purpose to combat NWS myiasis. It is not yet available to the public for purchase, so there are no other distributors of the drug other than Zoetis in the U.S.

https://www.fda.gov/news-events/press-announcements/fda-conditionally-approves-first-drug-prevention-and-treatment-new-world-screwworm-infestations https://www.avma.org/news/first-drug-screwworm-treatment-prevention-receives-conditional-approval

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

Two of the Secretary’s points in the plan were to 1) remove any regulatory hurdles by working with EPA, FDA and others to ensure access to effective wound and treatment products that fall under their jurisdiction, and 2) ensure we (USDA) have sufficient treatments by stockpiling these as a backstop for states as commercial developments accelerate. The HHS Secretary declared NWS a public health emergency, thereby expediting the ability for FDA to offer approval/conditional approval to products by veterinary drug manufacturers in a shortened timeframe. While there are products authorized under the Emergency Use Authorization from FDA, they will require veterinary intervention to administer those off label to an animal. Given the shortage of large animal veterinarians nationwide, this could hamper the prevention and treatment of animals around the country. Because Dectomax CA-1 from Zoetis has received conditional approval from FDA, producers will be able to administer the product without a veterinarian and in compliance with labeling instructions. This will drive up the demand for this product in at risk states, potentially leading to shortages. Additionally, this labelled product (CA-1), is not yet commercially available to the public. Zoetis is in the process of re-labelling the product, but USDA has an opportunity to purchase this product before it is commercially available. This makes this request one of unusual and compelling urgency since there is a bona fide need for the product, precluding full and open competition. Zoetis is the only manufacturer of this product.

The NWS fly has been detected within 70 miles of the U.S. border with Texas, one of the top cattle producing states, and an established fly population has been detected in within 200 miles of the border. APHIS expects the fly could be detected in the U.S. by early spring. When this happens, international trade and interstate commerce with the affected state(s) will be immediately impacted, causing significant harm to the U.S. economy and the affected state(s). Both animals and humans can become infested with the NWS larvae, and the Department of Health and Human Services has already declared an emergency to allow the use of certain drugs (either conditionally approved as Dectomax CA-1 or extra label usage of other drugs, requiring a veterinary prescription). While it could take months to follow normal procedures and timeframes, more animals and humans could become infested as the economy is negatively impacted. By quickly purchasing and stocking this drug in the stockpile, USDA is helping to mitigate the impact of NWS in the U.S.

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

None.

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

Zoetis could eventually make this product available to distributors. The federal government may then be able to make acquisitions from distributors as small businesses.

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

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.

______________________ ________2/12/2026__________ Name Joanna Davis DVM Date Title

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.

Name Jason Wilking Date Contracting Officer