2024_BIAH ORV Bait FAR 6.302_Justification for Other Than Full Open Competition_1.pdf

United States Department of Agriculture

Justification for Other than Full and Open Competition

Federal Acquisition Regulation (FAR) Part 6.3 (FAR 6.302-1 – Only One Responsible Source and No Other Supplier or Satisfy Agency Requirements)

1. Identification of the agency and the contracting activity.

Requesting Agency:

USDA, Wildlife Services

National Rabies Management Program

USDA, APHIS, Wildlife Services

Milton, FL 32583

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 Boehringer-Ingelheim

Animal Health USA, Inc. (formerly Merial, Inc.), of Athens, Georgia.

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.

Rabies control requires ORV baits fully licensed for use in the United States by USDA. The oral vaccine is a live recombinant that uses attenuated Vaccinia (V) virus to vector the rabies glycoprotein

(RG) gene which produces antibodies against rabies infection in most carnivore species. Currently the licensed products available in the U.S. for wildlife are coated sachet (128370), and fishmeal polymer

(128425). These products are manufactured under the product name RABORAL V-RG® by

Boehringer-Ingelheim Animal Health USA, Inc. (formerly Merial, Inc.), Athens, Georgia.

This IDIQ contract will provide access to ORV baits needed to address critical rabies emergencies in real-time. The period of performance will be 36 months from desired award date of June 1st, 2024, to

May 31st, 2027, with an estimated value of $13,410,250.00. The minimum contract obligation created against this justification will be fully funded with Rabies Appropriated and, if approved, Commodity

Credit Corporation (CCC) funding or INLAR funding.

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

41 U.S.C. 3304(a)(1), as implemented by FAR 6.302-1, titled "Only one responsible source and no other supplies or services will satisfy agency requirements."

5. A statement demonstrating the unique qualifications of the proposed contractor or the nature of the action requiring the use of the authority.

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 (up to 10 million baits annually to meet long-term goals of rabies elimination in wild carnivores) and delivered in different bait formats on the required schedule for rabies control in the United States. The potential harm of not acquiring

BIAH USA Inc.’s product at this time would be catastrophic to >25 years of progress made to date by

USDA and cooperators toward eliminating rabies in wild carnivores in the United States.

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 BIAH 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.

Vaccine baits are readily available and have been purchased for use by local, state, and federal government agencies for 25 years. 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. No other licensed manufacturers of oral rabies vaccine baits were identified other than BIAH (Boehinger-Ingelheim Animal Health USA, Inc.).

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 spread from infected rodents and wild carnivores. The effort cannot be duplicated or replicated with another contractor at this time without undue exposure risk to the public and delay to the government.

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 vaccine-bait undergoing field testing in support of future licensure, but this vaccine-bait is not available for purchase on demand for wide scale operational use in all program states at this time. The potential alternate bait is called Ultralite (ONRAB), manufactured by a Canadian firm named Artemis Technologies Inc., an indirect, wholly owned subsidiary of Ceva Santa Animale, S.A.

If 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 will consider the alternate baits if or when the Ultralite is awarded a license for expanded use in the United States.

Certifications & Approvals

Supporting data that form the basis for and included in this justification are certified accurate and complete. Digitally signed by JORDONA KIRBY

DN: c=US, o=U.S. Government, ou=Department of

Agriculture, cn=JORDONA KIRBY, 0.9.2342.19200300.100.1.1=12001000206857

Date: 2024.04.09 08:35:00 -05'00'

Jordona Kirby

Rabies Field Coordinator

National Rabies Management Program

USDA, APHIS, Wildlife Services

Milton, FL 32583

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.

Charmion Harris 4/10/2024

Charmion Harris Date

Contracting Officer

USDA Animal and Plant Health Inspection Service

Procurement Branch – Minneapolis

250 Marquette Ave, Suite 410

Minneapolis, MN 55401

Howard Price Date

Mission Area Senior Contracting Officer

USDA Marketing and Regulatory Program

4700 River Road

Riverdale, MD 20737

JORDONA KIRBY

Additional Reviews & Approvals

Signatures are required at each threshold up to the total estimated dollar value of the acquisition

Advocate for competition for the procuring activity (if over $750,000, but not exceeding $15 million). 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. If required, my approval constitutes clearance for submission to the Head of the Procuring Activity.

Larry Nelson Date

Contracting Specialist; Activity Advocate for Competition

USDA Animal and Plant Health Inspection Service

Procurement Branch – Minneapolis

250 Marquette Ave, Suite 410

Minneapolis, MN 55401