Brand Name Justification - Dectomax 500mL Injectable Solution.pdf

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

Identification Number: 1174070

Pursuant to the requirements of the Competition in Contracting Act as implemented by Revolutionary Federal Acquisition Regulation (FAR) Overhaul (RFO) FAR Part 6 and in accordance with the requirements of RFO FAR 6.104-1, the justification for the use of the statutory authority cited herein is supported by the following facts and rationale:

(1) Mission Area and Contracting Activity.

The United States Department of Agriculture, Animal Plant Health Inspection Service (APHIS), Marketing Regulatory Programs Business Services, Acquisition and Asset Management Division, Acquisition Branch, proposes to enter into a contract on a basis other than full and open competition (Brand Name), on behalf of Animal Plant Health Inspection Service, Veterinary Services, Cattle Fever Tick Eradication Program (CFTEP).

(2) Nature and/or description of the action being approved:

This J&A authorizes and approves the solicitation and award of a firm-fixed price one-time commercial purchase of a veterinary pharmaceutical product on a brand-name only basis. T under the Revolutionary FAR Overhaul (RFO) Part 12 streamlined procedures for commercial products.

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

APHIS intends to award a firm‑fixed‑price, brand‑name‑only purchase order for Dectomax® 1% doramectin injectable, 500 mL using commercial item simplified procedures under 41 U.S.C. 1901 (RFO FAR Part 12). Estimated value: $400,800.

(4) Identify 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 FAR 6.103-1 (d), Brand Name

(5) Demonstrate that the proposed contractor's unique qualifications or the nature of the acquisition requires using the authority cited.

APHIS has determined that Dectomax® 1% Injectable Solution (doramectin) possesses unique capabilities that are essential to our requirements, and no other product meets these needs. The critical distinguishing requirement is the route of administration and formulation: the product must be an injectable formulation of doramectin (or an equally effective systemic endectocide). This requirement arises from the specific needs of APHIS’s cattle fever tick and screwworm programs:

(a) Cattle Fever Tick Eradication Program (CFTEP) treatment protocols that rely on residual systemic activity to interrupt tick life cycles; and

(b) New World Screwworm (NWS) preparedness and response, where a single‑dose injectable provides effective treatment and short‑term prevention during outbreaks, including in operational settings where repeated topical application is impractical.

Rev. 10/29/25

Doramectin’s withdrawal period in cattle is 35 days, and the new Emergency Use Authorization (May 19, 2026) for Dectomax Injectable extends its NWS indications to multiple species including dairy cattle (under specific conditions), horses, sheep, swine, and deer.

Injectable route of administration is essential. Topical (pour‑on) products do not provide equivalent systemic exposure, duration, or operational reliability for CFTEP and NWS response.

Dectomax® 1% Injectable is the only commercially available product that meets these minimum needs. No generic or alternate manufacturer offers an equivalent injectable doramectin. Products such as DectoGard™ are topical formulations and do not meet the minimum requirement for injectable, systemic delivery. Other parasiticides differ in active ingredient, labeling/authorization, efficacy for these missions, or operational suitability.

Accordingly, the requirement is peculiar to one manufacturer, and no other supplies will satisfy agency requirements.

(6) Provide a description of efforts made to ensure that offers are solicited from as many potential sources as possible, including whether a notice was or will be publicized as required by Part 5 and, if not, which exception under Part 5 applies.

The proposed contract will be synopsized on SAM.gov in accordance with applicable RFO Part 5 requirements for acquisitions exceeding $25,000, using a brand-name only solicitation title and including this justification as an attachment. Although the requirement is restricted to Dectomax (a sole-manufacturer product), the solicitation will be issued to, and advertised for, all qualified vendors who are authorized distributors of Zoetis’s Dectomax. Multiple distributors (including small business distributors) are expected to compete on price. This strategy will ensure we obtain competitive pricing for the brand-name item to the maximum extent practicable, even though competition is not available at the product level. Any vendor that can provide the exact required product (Dectomax 500 mL injectable) and meet the delivery requirements will be considered.

Quotes offering alternate products will be deemed non-responsive to the solicitation because only the specified brand-name injectable meets the agency’s essential requirements.

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

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

The Contracting Officer has determined the anticipated cost to the Government of the supplies/services covered by this J&A will be fair and reasonable based on a thorough comparison of historical pricing data from the prior contract and the development of an Independent Government Cost Estimate (IGCE) using current market rates.

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

Market research (FDA/CVM listings, manufacturer and distributor inquiries, and program technical review) confirmed no alternative injectable doramectin is available. Evaluated alternatives were either topical, lacked appropriate authorization/use, or failed to meet program efficacy and operational requirements.

(9) Any other facts supporting the use of other than full and open competition, such as:

Failure to obtain the required injectable doramectin would materially impair APHIS’s ability to control cattle fever ticks and rapidly respond to NWS, posing significant animal health and economic risk.

(10) A listing of the sources, if any, that expressed an interest in the acquisition in writing.

No sources identified that can provide an injectable doramectin equivalent. Authorized Dectomax® distributors are expected to compete, including sources competing for a Fiscal Year 2025 requirement for the same product.

(11) A statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition of the supplies or services required.

APHIS is committed to enhancing competition for its procurements whenever possible. The brand-name restriction in this case is driven by current market conditions and urgent program needs.

Moving forward, APHIS will continue to support and monitor efforts to develop alternative treatments for cattle fever ticks and NWS. Notably, FDA’s recent actions (conditional approvals, EUAs) indicate that new products are being explored (e.g., fluralaner pour-on for NWS/ticks, ivermectin EUA for NWS, etc.). APHIS will remain engaged with FDA, industry, and research partners (such as USDA’s Agricultural Research Service) to encourage the development of additional approved treatment options – for example, novel antiparasitic formulations or vaccines – that could provide more choices in the future. If and when a comparable or superior product becomes available (e.g., a fully approved alternative injectable or a more versatile treatment), APHIS will reassess its requirements to determine whether a less restrictive competitive procurement is possible. In the interim, this acquisition is limited to Dectomax out of necessity. By documenting the rationale in this justification, we ensure that this exceptional use of a brand-name-only specification is transparent and will be revisited as soon as conditions allow broader competition.

(12) Certifications & Approvals

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.

Troy Trevino Management and Program Analyst

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.

Samuel Lopez Contracting Officer