JOFOC--CSF DIVA -- 11-29-21--FBO.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) Vaccine that is capable of differentiating infected from vaccinated animals (DIVA), and has been issued a Permit for Distribution and Sale by the USDA Center for Veterinary Biologics (CVB). Vaccine price must include storage (and labelling if needed) 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 CSF vaccine to replenish the NVS. Zoetis will perform all tasks required of a Permittee in order to maintain USDA Product Permits for Distribution and Sale of CSFV Vaccine (DIVA), 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, completing quarterly reports, and serving as the liaison for all submissions and correspondence related to Permittee and/or the inspected foreign manufacturing facility.

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, Zoetis is the sole supplier of CSFV Vaccine (DIVA) 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 Zoetis can supply pure, safe, potent and effective CSFV Vaccine (DIVA), which might be needed if and when an outbreak of classical swine fever (CSF) occurs in the United States. Zoetis has the permit that allows the importation of CSFV Vaccine from its inspected foreign manufacturing facility in Belgium to its USDA inspected facility located in Lincoln, NE.

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

For this particular effort a Request for Information (RFI) was posted on April 20, 2021 with a response date of July 20, 2021 in an attempt to find other interested parties. APHIS received no responses to the RFI so we were unable to find any competitors who were capable of delivering a CSFV Vaccine (DIVA) suitable for purchase by the NVS. No other domestic or foreign manufacturing facilities are currently capable of manufacturing CSFV Vaccine (DIVA).

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 RFI for 90 days to determine interest/capability to provide the vaccine.

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

Zoetis has the capabilities for refrigerated storage of CSFV Vaccine (DIVA) at its facilities in Lincoln, NE. Domestic storage of NVS-owned vaccine allows quick deployment of vaccine within the U.S., thus meeting one of the goals of HSPD-9: to “deploy within 24 hours sufficient amounts of animal vaccine, antiviral, or therapeutic products to appropriately respond to the most damaging animal diseases affecting human health and the economy…”

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 Vaccine (DIVA).

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 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