A5_Limited Source_Part 13.ds.pdf

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United States Department of Agriculture Sole Source (ONRAB Ultralite) Justification under

Simplified Procedures for Certain Commercial Items (FAR 13.5) Control No. (if applicable) ______________________

1. Identification of the agency and the contracting activity.

1a. Requesting Activity Agency:

USDA, APHIS, Wildlife Services National Rabies Management Program Concord, NH 03301-8548

1b. Contracting Activity:

USDA, APHIS, MRPBS, 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 proposes to enter into a contract on a basis other than full and open competition, and negotiate a sole source, firm fixed-price IDIQ commercial supply contract with Artemis Technologies Inc., an indirect, wholly-owned subsidiary of Ceva Santé Animale, S.A., Guelph, Ontario, Canada (DUNS: 179190116 CAGE Code: 4TKA0).

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

Oral Rabies Vaccine (ORV) baits of various types and formats support the Wildlife Services National Rabies Management Program in its continued efforts to control and eliminate rabies in wildlife. Several formal field trials and supplementary research studies to evaluate the safety, immunogenicity and effectiveness of an experimental ORV bait, human adenovirus type 5-rabies glycoprotein recombinant vaccine (AdRG 1.3), have been conducted by Wildlife Services since 2011. New applications of ONRAB planned for 2025-2026 include evaluating its use with greater frequency (i.e., two times per year application instead of one) in areas identified to have a higher risk of rabies spread.

Effective wildlife rabies control and eventual elimination requires full evaluation of new oral vaccines in the United States by USDA. The experimental oral vaccine is a human adenovirus type 5-rabies glycoprotein recombinant vaccine (AdRG1.3), which produces antibodies against rabies infection in most carnivore species. This experimental product available in the U.S. for wildlife is a single format and is manufactured under the product name ONRAB by Ceva Santé Animale, S.A., Guelph, Ontario, Canada. ONRAB is licensed for use in Canada.

This IDIQ contract will provide access to experimental ORV baits needed for continued field testing to support the National Rabies Management Program’s strategic wildlife rabies management goals. The period of performance will be 12 months from desired award date of April 1, 2025, to March 31, 2026, with an estimated value of $7,448,900.00 (assuming product pricing is comparable to previous contracts).

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The minimum contract obligation created against this justification will be fully funded with Rabies Appropriated and Commodity Credit Corporation (CCC) funding that was approved in July 2024.

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

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.

Artemis Technologies Inc., an indirect, wholly-owned subsidiary of Ceva Santé Animale, S.A., currently is the only oral rabies vaccine bait manufacturer that produces an experimental oral rabies vaccine bait, ONRAB, available for ongoing field evaluation in the U.S. The potential harm of not acquiring Artemis Technologies Inc.’s product at this time would be detrimental to more than 10 years of extensive research conducted by USDA and cooperators evaluating the safety, immunogenicity and effectiveness of this oral rabies vaccine in targeted wildlife to control rabies in the U.S.

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

A notification of the Agency’s intent to negotiate a sole source contract with Artemis Technologies Inc., an indirect, wholly-owned subsidiary of Ceva Santé Animale, S.A., will be publicized on SAM.gov to notify interested parties and encourage private development of other oral rabies vaccine baits. The synopsis of the pending action will include information as to how interested parties may submit products and proposals for review and consideration.

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

USDA has been purchasing ONRAB oral rabies vaccine baits to conduct field trials and supplementary research studies since 2011. Adequate current and historical pricing information exists to negotiate and establish a fair and reasonable price despite the lack of current competition.

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

Resources available via the internet were investigated along with in-house historic data on previous Oral Rabies Vaccine baits. In addition, the licensing entity for all animal vaccine use in the United States, The Center for Veterinary Biologics, Ames, Iowa was contacted to identify qualified sources and potential alternate products. Artemis Technologies Inc., an indirect, wholly-owned subsidiary of Ceva Santé Animale, S.A, was the only identified manufacturer of an experimental oral rabies vaccine bait available for field evaluation in the U.S.

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

USDA is preparing the required authorizations, justifications, and determinations needed to effectuate this sole-source requirement for the ORV baits. This sole source contract will sustain the ongoing effort to mitigate the risk of avoidable human deaths caused by rabies that can be

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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.

There is another oral rabies vaccine bait, RABORAL V-RG®, that is fully licensed for wildlife and has been used at a wide scale operationally in the U.S. in 15 states to prevent raccoon rabies from spreading appreciably. However, achieving elimination of raccoon rabies requires higher levels of rabies antibody seroconversion in raccoon populations targeted for oral vaccination at currently used bait densities. There is a need to also orally vaccinate skunks, as raccoon rabies often spills over into the skunk population, a potential source of re-infection in raccoons. ONRAB was identified as a candidate for testing, in part, because this oral vaccine has produced favorable control in raccoons and, in some cases, skunks in Canada. Use of the experimental product is limited to specific states; thus, both products are necessary to complete the mission. If ONRAB becomes licensed, the baits would be available for purchase on a wider scale. This contract is executed for less than the 5-year period typically found with IDIQs to ensure the Government can equally consider both bait types if or when ONRAB is awarded a license for expanded use in the U.S.

Certifications & Approvals

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

Jordona Kirby Rabies Field Coordinator National Rabies Management Program USDA, APHIS, Wildlife Services

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.

Amanda Barbosa Major Program Contracting Officer, Wildlife Services USDA MRP AAMD Acquisition

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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.

Insert Name of the Procuring Activity Competition Advocate/MASCO Title:

Procuring Activity Advocate for Competition