JOFOC--CSF Cstrain--8-22-24.pdf

JUSTIFICATION FOR

OTHER THAN FULL AND OPEN COMPETITION

1. Identification of the agency and the contracting activity:

Requesting Agency:

USDA, APHIS, Veterinary Services National Veterinary Stockpile 4700 River Road Riverdale, MD 20737

Contracting Activity:

USDA, APHIS, Marketing and Regulatory Programs Business Services Acquisition and Asset Management Division Procurement Branch 250 Marquette Ave, Suite 410C Minneapolis, MN 55401

2. Nature and/or Description of the action being approved:

The proposed action is for the production, testing, labelling, shipment, and storage of one million doses of Classical Swine Fever Virus (CSFV) C-strain Modified Live Virus (MLV) Vaccine that has been issued a Permit for Distribution and Sale by the USDA Center for Veterinary Biologics (CVB). Vaccine price must include storage throughout vaccine dating. The vaccine will become part of the National Veterinary Stockpile (NVS) to be available for any animal emergencies.

3. Description of Supplies or Services required to meet the agency’s needs (including the estimated value):

This justification is for a one-time purchase of one million doses of CSFV C-strain MLV vaccine to replenish the NVS.

Ceva will perform all tasks required of a Permittee to maintain USDA Product Permits for Distribution and Sale of CSFV C-strain MLV Vaccine, and an approved inspected foreign manufacturing facility. Tasks include but are not limited to maintaining current facility documents, Outlines of Production, updated APHIS Forms 2007 (personnel qualifications), arranging and paying for biennial USDA CVB on-site facility inspections and serving as the liaison for all submissions and correspondence related to Permittee and/or the inspected foreign manufacturing facility.

Ceva is the only manufacturer with a USDA Veterinary Biological Products License or Product Permit for Distribution and Sale of CSFV C-strain MLV Vaccine. No other firm has submitted a request to the USDA Center for Veterinary Biologics to start the process to obtain a Veterinary Biological Product License or Permit for Sale and Distribution. Once the process has begun it normally takes at least 2 years before a license or permit can be issued. The USDA has inspected and approved Ceva’s foreign manufacturing site in Germany and its cold storage facility in France.

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

41 U.S.C. 253 (c)(1) Only one responsible source and no other supplies or services will satisfy agency requirements and 41 U.S.C. 1901 – Simplified Acquisition Procedures up to $7.5 million as authorized by FAR 13.501(a)

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

Currently, Ceva is the sole supplier of CSFV C-strain MLV Vaccine for which the USDA has issued an import Permit for Distribution and Sale. The 9 CFR 104.2 defines a Permittee as a person who resides in the United States or operates a business establishment in the United States to whom a permit to import biological products has been issued.

The USDA has determined that Ceva can supply pure, safe, potent and effective CSFV C-strain MLV Vaccine, which might be needed if and when an outbreak of classical swine fever (CSF) occurs in the United States. Ceva has the permit that allows the importation of CSFV Vaccine from its inspected foreign manufacturing facility in Reims, Germany, and USDA inspected cold storage facility in Libourne, France.

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

For this particular effort a Sources Sought notice was posted on March 22, 2024 with a response date of April 22, 2024 in an attempt to find other interested parties. APHIS received no responses to the Sources Sought so we were unable to find any competitors who were capable of delivering a CSFV C-strain MLV Vaccine suitable for purchase by the NVS.

7. A determination by the Contracting Officer that the anticipated cost to the Government will be Fair and Reasonable:

The USDA, APHIS, VS has purchased this product for many years so the agency has historical pricing which can be used in determining price reasonableness. No contract will be issued until the contractor price has been determined to be fair and reasonable.

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

The government is fully aware of the market conditions and availability of this product from previous purchases.

Market research was conducted for this current requirement which included the posting of the Sources Sought notice for 30 days to determine interest/capability to provide the vaccine.

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

Previously, Ceva was awarded a contract to supply the NVS with CSFV C-strain MLV vaccine. It has demonstrated that it can successfully manufacture and test CSFV C-strain MLV vaccine at it manufacturing site in Germany, and store vaccine at its cold storage facility in France.

10. A listing of sources, if any, that expressed a written interest in the acquisition:

At this time no other entity has obtained a USDA issued Veterinary Biological Product License or a Product Permit for Distribution and Sale for CSFV C-strain MLV Vaccine.

11. A statement of actions, if any, the agency may take to remove or overcome any barriers to competition if subsequent acquisition are anticipated:

The USDA Center for Veterinary Biologics has provided the USDA Minneapolis Business Services office with lists of domestic and foreign manufacturers prior to announcements of solicitations to procure foreign animal disease vaccines.

Certifications & Approvals

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

Dr. Bruce Carter Global Vaccine Manager Center for Veterinary Biologics

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.

Larry Nelson Contracting Officer

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, I hereby approve this justification.

Larry Nelson Procuring Activity Advocate for Competition