Sole Source.pdf

JUSTIFICATION AND APPROVAL

TO PROCURE USING OTHER THAN FULL AND OPEN COMPETITION

Upon the basis of the following justification for the United States Department of Agriculture, Animal and Plant Health Inspection Service, I as Competition Advocate for the procuring activity, 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).

1. Agency and Contracting Agency. United States Department of Agriculture, Animal and Plant Health Inspection Service, Procurement Branch, Minneapolis, MN.

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 consist of a one-year base period of performance. Approval is requested to use other than full and open competition for the procurement of Oral Rabies Vaccine baits of various types and formats to support the Wildlife Services National Rabies Management Program in its continued efforts to control and eliminate rabies in wildlife. The proposed contract will be an Indefinite Quantity Indefinite Delivery (IDIQ) Firm fixed priced commercial supply contract. The minimum contract obligation created against this justification will be fully funded with Rabies Appropriated and, if approved, Commodity Credit Corporation (CCC) funding.

3. Description of Supplies/Services. This acquisition is for delivery of baits containing oral rabies vaccine upon demand. Wildlife Services proposes to purchase two types of baits containing oral rabies vaccine: fishmeal polymer, and coated sachet baits.

The only oral rabies vaccine baits fully licensed for use in the United States by USDA or other appropriate federal, state or county agencies are the coated sachet (2315-01), and fishmeal polymer (2316R-01), all of which are manufactured under the product name RABORAL V-RG® by Boehinger-Ingelheim Animal Health USA, Inc. (BIAH;

formerly Merial, Inc.), Athens, Georgia. The oral vaccine contained in all bait types is the same, a live recombinant that uses attenuated Vaccinia (V) virus to vector the rabies glycoprotein (RG) gene. The vaccine cannot cause rabies but produces antibodies against rabies infection in most carnivore species that receive an adequate dose.

Rabies control frequently requires immediate access to additional baits in excess of annual forecasts for control operations to address critical rabies emergencies in real-time.

Access to bait of varying types is required. To accommodate this critical need, baits must be purchased in advance and stored in a controlled environment that ensures bait and vaccine integrity and guarantees that shelf life of product is not exceeded.

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 50,000 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 mongoose in Puerto Rico) and bats that have, for the past 3 decades, 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.

Oral rabies vaccination (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 17 states in 2021. 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 2004, 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 within the next 4 to 5 years. Only 1 case of gray fox rabies in Texas has been reported since 2013.

After this variant is contained ORV may be required to maintain zones to prevent reemergence or respond to reemergence from sources in Mexico. 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.

Consequently, there is an annual need for up to 10 million baits containing effective oral rabies vaccine to sustain this program to meet long-term goals of rabies elimination in wild carnivores. Baits must be available on demand and contain effective vaccine that has met all of the experimental or full vaccine licensing requirements in the United States.

Boehinger-Ingelheim Animal Health USA, Inc. is the only entity in the United States that has a licensed oral rabies vaccine that can be produced in high volume and delivered in different bait formats on the required schedule for rabies control in wild carnivores in the United States. The potential harm of not acquiring BIAH USA Inc.’s product at this time would be catastrophic to progress made to date by USDA and cooperators toward eliminating rabies in wild carnivores in the Untied States.

6. Efforts to Obtain Competition: Market research was performed by the Contract Specialist. 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. No other licensed manufacturers of oral rabies vaccine baits were identified other than BIAH (see Paragraph #7; there is another vaccine-bait undergoing field testing in support of future licensure, but this vaccine-bait is not available for purchase for wide scale operational use at this time).

A notification of the Agency’s intent to negotiate a sole source contract with BIAH will be publicized on FedBizOpps.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. Actions to Increase Competition: There is new rabies vaccine-bait currently being tested through field trials that likely will lead toward licensing in the United States.

The bait is called Ultralite (ONRAB), manufactured by a Canadian firm named Artemis Technologies. If licensed, the baits would be available for purchase on a wider scale.

This contract will be written for a 12-month period of performance to ensure the Government can consider the new baits if or when the Ultralite is awarded a license for expanded use in the United States.

8. Market Research: Market Research performed by the Contract Specialist and technical group did not identify any other sources currently able to meet the requirements. Previous contract history was analyzed, and internet sources used in making the determination that only one Oral Rabies Vaccine bait is fully licensed and currently available for Agency use.

9. Interested Sources: A synopsis of the pending action will be 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 purchased Oral Rabies Vaccine baits in the past from BIAH (company name formerly Merial, Inc. and Merial Limited in previous contracts), under Authority U.S.C 253 ( c ) (1). A 60-month contract was negotiated in 2002 with a base year and four option years. Additionally, a 60-month contract was negotiated in 2007 with a base year and four option years. A 36-month contract was negotiated in 2012 with a base year and two option years. Most recently, a 12-month contract has been negotiated annually since 2015. The current 12-month contract expires March 30, 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. The anticipated period of performance shall be 13 months.

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:

BIAH 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: BIAH produces Oral Rabies

Vaccine baits commercially and the product is readily available in the private marketplace (for use by local, state, and federal government agencies). Adequate pricing information exists to all the Government to negotiate and establish a fair and reasonable price despite the lack of current competition.

11. Listing of Interested Sources. The USDA is currently conducting field trials involving a vaccine-bait manufactured by Artemis Technologies. If licensed, this bait may be more widely available for purchase in 12 months.

12. Statement of Delivery Requirement. The period of performance for the proposed acquisition is from the effective date of contract award through 13 months.

13. Total Estimated Dollar Value of the Acquisition Covered by this J&A. The total estimated value of the proposed acquisition is $9,875,250.00.

14. 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 Kirby December 15, 2020 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 41 U.S.C. 253(c) for the procurement of rabies baits.

Name: Larry Nelson ________________________________________ Title: Competition Advocate (signature) (date) for the procuring Activity

Contract Specialist: Jason Wilking _________________________________02/25/2021_______