A1 2021_Artemis Sole Source 30JNov2020 signed.pdf

JUSTIFICATION AND APPROVAL

TO PROCURE USING OTHER THAN FULL AND OPEN COMPETITION

IDENTIFICATION OF THE AGENCY AND THE CONTRACTING

ACTIVITY:

Requesting Agency:

USDA, APHIS, Wildlife Services

National Rabies Management Program 59 Chenell Dr., Ste. 2 Concord, NH 03301

Contracting Activity:

USDA, APHIS, MRPBS, ASD

Minneapolis Procurement Branch 250 Marquette Ave Suite 410 Minneapolis, MN 55401

NATURE AND/OR DESCRIPTION OF THE ACTION BEING

APPROVED:

The United States Department of Agriculture (USDA)/Animal Plant Health Inspection Service (APHIS)/Wildlife Services, National Rabies Management Program in Concord, NH intends to award a sole source contract to Artemis Technologies, LLC (DUNS:

179190116 CAGE Code: 4TKA0) for the supply of the oral rabies vaccine ONRAB Ultralite baits. Wildlife Services proposes to purchase up to 7,500,000 units of the Ultralite bait containing the oral rabies vaccine ONRAB. The estimated value is $11,000,000.00

IDENTIFICATION OF THE STATUATORY AUTHORITY PERMITTING

NONCOMPETITIVE ACQUISITIONS:

1. Upon the basis of the following justification, I, as the Contracting Officer, for United States Department of Agriculture, Animal and Plant Health Inspection Service, hereby approve the use of other than full and open competition for the proposed contractual action pursuant to the authority of 41 U.S.C. 253(c).

2. Nature/Description of Action(s). This document is formatted in accordance with the guidelines provided under FAR 6.303-1, Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements, for sole source procurement. The effort will be a one year period of performance for the oral rabies vaccine-bait ONRAB® in an Ultralite bait to expand upon field trials conducted with this product in 2011 (WV) and 2012 (WV, OH, NY, NH, VT) to further evaluate its safety and immunogenicity to control rabies in wildlife. Continued expansion was considered warranted based on the favorable safety and vaccine-induced antibody results of the first field trial with ONRAB in an Ultralite bait conducted in 2011. From 2013-2015, WS expanded field trials in an area in Northern New York (St. Lawrence County) to scientifically replicate field trials that were conducted in VT, NH and NY in 2012-2014.

WS also began to evaluate the ONRAB vaccine-bait at different baiting densities in VT and NH during 2015, which was completed in 2017. During 2017 and 2018, WS initiated contingency response actions in OH using the ONRAB vaccine-bait, which will continue to be evaluated through 2021.

Approval is requested to use other than full and open competition for the procurement of the Ultralite oral rabies vaccine-bait for continued field testing to support the Wildlife Services National Rabies Management Program to enhance its continued efforts to control and eliminate rabies in wildlife. In order to fully scientifically test the immunogenicity of this vaccine under field conditions, each study at each location requires up to three field seasons. As a result (depending on annual results), we will be requesting to purchase baits in 2021 in order to fully complete field evaluations. The minimum contract obligation created under this justification will be fully funded with Rabies Appropriated funding.

3. Description of Supplies/Services. This acquisition is for the purchase of Ultralite baits containing oral rabies vaccine, to be shipped during up to two time periods (August and October 2021) during 2021 and 2022. Wildlife Services proposes to purchase up to 3,750,000 units annually of the Ultralite bait containing the oral rabies vaccine ONRAB.

Each Ultralite bait contains 1.8±0.1 ml of ONRAB vaccine (titer of not <109.5 cell culture infectious dose 50% [CCID50]/ml) in an elongated plastic blister pack that is coated with an attractant-bait matrix. The attractant on the vaccine-baits is composed of partially hydrogenated vegetable shortening (34%), Microbond® wax (International Wax Ltd., Agincourt, Ontario, Canada) (30%), stearine (12.5%), icing-sugar (20%), vegetable oil (1%), artificial marshmallow flavor (1%), artificial sweet flavor (1%), and a fat-soluble food dye (0.5%) (khaki green) to camouflage the baits. The bait matrix also contains 100 mg of tetracycline hydrochloride as a biomarker to evaluate bait ingestion. Each vaccine-bait weighs approximately 4 g. The body of the blister pack is an elongated oval with dimensions of 1.81x 0.55x 0.39in (30x14x10 mm) and a rectangular lip extending to 1.57x 0.79 in (40x20 mm) (Figure 1-1). The blister pack contains an identifying label as to the contents of the bait and a toll-free phone number where people can obtain information about the baits.

4. Identification of Statutory Authority. FAR 6.302-1, Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements, 41 U.S.C.

253 (c) (1)

5. Reason for Authority Cited. The Act of March 2, 1931 (7 U.S.C. 426-426b and 426c), as amended, provides the Secretary of Agriculture authority to conduct and cooperate in rabies control in wildlife. Rabies is one of the oldest recorded mammalian diseases. All mammals, including humans, are susceptible to rabies. Rabies is almost always transmitted by the bite of a rabid animal, usually a carnivore or insectivorous bat.

If humans do not receive timely post-exposure treatment, rabies is fatal. Ready access to treatment, integrated with public health education, and pet vaccination programs, has effectively kept the annual human death rate near zero in the U.S. and other developed countries. Worldwide, however, the human mortality rate from rabies is estimated at 55,000 to 70,000 annually. Post exposure treatment is not available for animals;

consequently, animals infected with rabies typically bite or attempt to bite other animals when the disease becomes clinical, often transmitting the fatal virus before they die.

Before 1960, the majority of positive rabies cases were reported in dogs. The combination of public education and pet vaccination programs, however, has effectively controlled rabies in companion animals. By the early 1960’s wildlife surpassed the dog in reported rabies cases. The principal rabies reservoirs are wild carnivores (raccoon, skunk, fox, coyote; and the mongoose in Puerto Rico) and bats that have, for the past twenty years, accounted for 90% or greater of all positive rabies cases reported in animals in the United States and Puerto Rico. Varying ecological, behavioral and biological attributes of diverse carnivore and bat vectors introduce new challenges to contemporary rabies control programs that underscore the need for interdisciplinary collaboration among wildlife professionals, veterinarians, physicians, public affairs specialists, environmental compliance experts, economists, and others.

ORV targeting rabies in red foxes began in Europe in 1977, with several countries now classified as rabies free from coordinated campaigns, while others continue to conduct ORV with the goal of rabies elimination. ORV was initiated in Ontario, Canada in 1989, where fox rabies and raccoon rabies have nearly been eliminated through strategic use of this technology.

In 1998, USDA, APHIS, Wildlife Services initiated a national cooperative ORV program, which now includes 14 states in 2020 (3 additional states using ORV are non-federally funded). ORV zones are integrated with natural geographic features such as large lakes, rivers and poorer raccoon habitats at high elevations where practical to bolster vaccination barriers and reduce the overall cost of rabies control. ORV was implemented to eliminate canine rabies (spread predominantly by coyotes) from south Texas. This goal was achieved in 2000, but a 65-km wide maintenance vaccination barrier has been created along the Rio Grande to prevent re-infection from Mexico. The containment barrier for gray fox rabies that was created in 1996 in west-central Texas has been collapsed and the last case of gray fox rabies in Texas was reported in 2013. Much of the remaining effort is to contain raccoon rabies that occurs from Maine to southwest Alabama from spreading to new areas, while exploring elimination strategies.

USDA, APHIS, Wildlife Services (WS) and state and federal collaborators conducted field trials during 2011-2018 to evaluate the safety and efficacy of a human adenovirus type 5-rabies glycoprotein recombinant (AdRG1.3) ONRAB rabies vaccine in raccoons and striped skunks. To date, RABORAL V-RG® (a vaccinia-rabies glycoprotein recombinant oral rabies vaccine), the only oral rabies vaccine licensed for use in the United States to control rabies in raccoons and coyotes, has been the only oral rabies vaccine used operationally in rabies control campaigns. This vaccine has allowed WS and cooperators to prevent raccoon rabies from spreading appreciably but achieving elimination of raccoon rabies is expected to require higher levels of rabies antibody seroconversion in raccoon populations targeted for oral vaccination at currently used bait densities. In addition, 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 demonstrated higher levels of rabies antibody seroconversion in raccoons than the oral vaccine currently in use in the United States in two cross border comparison studies. In addition, it has produced favorable control in raccoons and, in some cases, skunks in Canada. Although the recombinant ONRAB vaccine has been used extensively in southern Ontario since 2006 and Quebec since 2007 with good reported success, the 2011-2018 field studies represented the first release of this vaccine into the field in the United States. Additionally, WS initiated two contingency responses in OH (one during 2017 and one during 2018) using the ONRAB vaccine-bait, which will continue to be evaluated through 2021. In order to fully scientifically test the immunogenicity of this vaccine under field conditions, it requires up to three field seasons at each location.

6. Efforts to Obtain Competition: The licensing entity for all animal vaccines used in the United States, The Center for Veterinary Biologics, Ames, Iowa was contacted to identify qualified sources and potential alternate products. Artemis Technologies, Guelph, Ontario, Canada was the only new identified manufacturer of rabies vaccine-bait for use in the U.S. Potential rabies vaccine manufacturers are encouraged to contact The Center for Veterinary Biologics to comply with the regulatory process that would allow for future field trials with other prospective oral rabies vaccines that could lead to licensing for use in rabies management in the U.S. WS has indicated the need and intent to conduct field trials to evaluate prospective oral rabies vaccine at Rabies in the Americas conferences, OIE Rabies conferences, and at other invited and open meetings through presentations and discussions for almost a decade. Artemis Technologies, Guelph, Ontario, Canada is the only manufacturer that has contacted APHIS, CVB with the intent to make available for field testing their vaccine-bait in the continental U.S., which is used extensively in wildlife rabies control in southeastern Canada. We welcome other vendors to contact APHIS, CVB if they have prospective oral rabies vaccines to be considered for field testing in the future. For field testing to occur, a product must be in full compliance with APHIS, CVB’s regulations and deemed suitable for distribution in accordance with the Virus-Serum-Toxin Act Title 9, CFR Sub- Chapter E. At this time, only two products are available for use in the United States.

RABORAL V-RG® (Merial Inc., Athens, Georgia) is currently used extensively in rabies management in the United States and ONRAB, specifically for the completed field trials and ongoing field studies.

7. Actions to Increase Competition: The Agency will remove any barriers to competition in the future by a public announcement via the Federal Business Opportunities website identifying the Government’s intent. The notification included information how interested parties may submit products and proposals for review and consideration and encourage private development of other oral rabies vaccine baits.

8. Market Research: 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, Guelph, Ontario, Canada was the only new identified manufacturer of rabies vaccine-bait for use in the continental U.S.

9. Interested Sources: A synopsis of the pending action was publicized. All future requirements will also be synopsized via the Federal Business Opportunities website to promote competition and industry interest.

10. Other Factors:

a. Procurement History: The USDA has been purchasing Oral Rabies Vaccine baits to conduct field trials to evaluate its safety and immunogenicity to control rabies in wildlife with this product annually since 2011. The testing is continuing through 2021.

b. Efforts to Retrieve Information: Program technical data, usage and application results and other information obtained under this program will be recorded and made available to potential future sources to encourage and assist them in competing for future requirements.

c. Development of Acquisition Data Suitable for Competition: This action is intended to satisfy the Agency’s need for immediate response to rabies exigencies and continued efforts to control and eradicate rabies in wildlife.

d. Harm to the Government in Unusual and Compelling Urgency: APHIS developed and implemented a cooperative rabies control program in which oral rabies vaccine is central to achieving the goals of rabies containment and elimination in wild carnivores. This program has a positive impact on public and animal health in the United States and globally by demonstration.

e. Steps Taken by the Government to Promote Sub-Contract Competition:

Artemis Technologies will be encouraged during the contract negotiation phase to utilize small business subcontractors to the maximum extent possible. The firm will also be offered Agency assistance and training on utilizing Small Business Administration resources and informed of program goals and objectives.

f. Determination of Fair and Reasonable Cost: Artemis Technologies produces Oral Rabies Vaccine baits commercially for use in Canada and the product represents a candidate for ongoing field testing in the United States. Adequate pricing information exists for the Government to negotiate and establish a fair and reasonable price despite the lack of current competition.

11. Listing of Interested Sources. No other qualified interested parties besides Artemis Technologies have been identified.

12. Total Estimated Dollar Value of the Acquisition Covered by this J&A. The total estimated value of the proposed acquisition is $11,000.000.00

13. Technical and Requirements Certification (FAR 6.303-2(b)). I certify that the facts and presentations under my cognizance, which are included in this justification and which form a basis for this justification are complete and accurate.

Name: Jordona D. Kirby

Title: Rabies Field Coordinator (signature) (date)

APPROVAL

Procuring Officer Certification (FAR 6.303-2(a) (12)). I certify that the facts and representations under my cognizance included in the Justification and Approval is/are accurate and complete to the best of my knowledge and belief.

On the basis of the foregoing justification, I hereby approve other than full and open competition basis pursuant to the authority of 10 U.S.C. 253(c) for the procurement of rabies baits.

Name: Jason Wilking

Title: Contract Specialist

Name: Larry Nelson

Title: advocate for competition of the procuring activity (signature) (date)