JOFOC_AG-6395-C-16-0094.pdf

JUSTIFICATION FOR OTHER THAN FULL AND OPEN COMPETITION

In accordance with the authority granted under FAR Part 13.5, this request for a noncompetitive acquisition is hereby submitted for consideration for acquisition approval.

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, AAMD

Minneapolis Procurement Branch Butler Square, Fifth Floor 100 North 6th Street Minneapolis, MN 55403

NATURE AND/OR DESCRIPTION OF THE ACTION BEING

APPROVED:

The United States Department of Agriculture (USDA)/Animal Plant Health Inspection Service (APHIS)/Wildlife Services (WS), National Rabies Management Program in Concord, NH, intends to award a sole-source, 1-year contract to Artemis Technologies, LLC for the supply of the oral rabies vaccine ONRAB® Ultralite baits. WS proposes to purchase up to 2,300,000 (approximately 639 boxes) units of the Ultralite bait containing the oral rabies vaccine ONRAB® during 2016.

A DESCRIPTION OF THE SUPPLIES, EQUIPMENT, OR SERVICES

REQUIRED TO MEET AGENCY NEEDS (INCLUDING THE ESTIMATED

VALUE OF THE ACQUISITION INCLUSIVE OF OPTIONS):

This acquisition is for a one-time delivery of Ultralite baits containing oral rabies vaccine during 2016 - unless an emergency rabies management situation warrants a second delivery for a contingency baiting response.

IDENTIFICATION OF THE STATUATORY AUTHORITY PERMITTING

NONCOMPETITIVE ACQUISITIONS:

41 U.S.C. 253(c)(1) FAR Part 6.302-1

The property or services needed by the executive agency are available from only one responsible source and no other type of property or services will satisfy the needs of the executive agency

These baits are not yet licensed for use in the United States and are being field tested.

The licensing entity for all animal vaccines used in the United States, The Center for Veterinary Biologics (CVB), 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 field testing to occur, a product must be in full compliance with 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 Ltd., Athens, Georgia) is currently used extensively in rabies management in the United States and ONRAB®, specifically for the proposed field trials.

A DEMONSTRATION THAT THE PROPOSED CONTRACTOR’S UNIQUE

QUALIFICATIONS OR THE NATURE OF THE ACQUISITION REQUIRES

USE OF THE AUTHORITY CITED:

WS and state and federal collaborators conducted field trials during 2011-2015 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, these field trials represented the first release of this vaccine into the field in the United States.

A DESCRIPTION OF EFFORTS MADE TO ENSURE THAT OFFERS ARE

SOLICITED FROM AS MANY POTENTIAL SOURCES AS IS

PRACTICABLE, INCLUDING WHETHER A NOTICE WAS, OR WILL BE,

PUBLICIZED AS REQUIRED BY FEDERAL ACQUISITION REGULATION

(FAR) SUBPART 5.2, AND IF NOT, WHICH EXCEPTION UNDER FAR 5.202

APPLIES:

- Previous 04/08/2015-FedBizopps Sources Sought Notice APHIS-WS-15-739942

- Previous 4/10/2015-FedBizopps Special Notice PR-15-739942

- Current 01/20/2016 Fedbizopps Special Notice (PR-16-781690)/cls 02/04/2016

No vendors have replied with capability statements

A DETERMINATION BY THE CONTRACTING OFFICER THAT THE

ANTICIPATED COST TO THE GOVERNMENT WILL BE FAIR AND

REASONABLE, AND THE BASIS FORTHAT DETERMINATION:

The oral rabies vaccine baits that will be purchased have been previously purchased for field testing by the USDA/WS under contract # AG-6395-C-15-0094. Since the product is a non-developmental commercial product, adequate pricing information exists and the Government intends to negotiate and establish a fair and reasonable price despite the lack of current competitions.

A DESCRIPTION OF THE MARKET RESEARCH CONDUCTED (FAR

PART 10) AND THE RESULTS, OR AN EXPLANATION OF THE REASON

MARKET RESEARCH WAS NOT PERFORMED:

01/20/2016 Fedbizopps Special Notice (PR-16-781690) closes on 02/04/2016.

Vendors are encouraged to send USDA their capability statements on or before closing date of notice.

ANY OTHER FACTS SUPPORTING THE USE OF OTHER THAN FULL

AND OPEN COMPETITION - FAR 6.303-2(a)(9):

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. 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 decade, 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, WS initiated a national cooperative ORV program, which expanded to include 17 states by 2007 and now includes 14 states in 2016. ORV zones were 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 with the goal of elimination over the next 4-5 years. Much of the remaining effort is to contain raccoon rabies that occurs from southwest Alabama to Maine from spreading to new areas, while exploring elimination strategies.

A LISTING OF SOURCES, IF ANY, THAT EXPRESSED, IN WRITING, AN

INTEREST IN THE ACQUISITON:

None

A STATEMENT OF THE ACTIONS, IF ANY. THE AGENCY MAY TAKE

TO REMOVE OR OVERCOME ANY BARRIERS TO COMPETITION

BEFORE ANY SUBSEQUENT ACQUISITION FOR THE SUPPLIES,

EQUIPMENT, OR SERVICES REQUIRED:

Will continue to publicize new requirements on Fedbizopps in search of new vendors and possible CVB licensing candidates.