JOFOC_interim_BI_DRAFT.DOC

USDA, APHIS, MARKETING AND REGULATORY SERVICES

JUSTIFICATION FOR OTHER THAN FULL AND OPEN COMPETITION (JOFOC)

JUSTIFICATION FOR OTHER THAN FULL AND OPEN COMPETITION

(SOLE OR SINGLE SOURCE)

In accordance with FAR Subpart 6.3, this request for a noncompetitive acquisition is hereby submitted for consideration for acquisition approval.

1. IDENTIFICATION OF THE AGENCY AND THE CONTRACTING

ACTIVITY:

Requesting Agency:

USDA, APHIS, MRPS, Veterinary Services

4700 River Road

Riverdale, MD 20737

Contracting Activity:

USDA, APHIS, MRPBS, ASD

Minneapolis Procurement Branch

250 Marquette Ave

Ste 410C

Minneapolis, MN 55401

2. NATURE AND/OR DESCRIPTION OF THE ACTION BEING

APPROVED:

USDA APHIS VS, acting as the agent of the North American Foot and Mouth Disease Vaccine Bank, seeks the award of a fiscal year (FY) 2019 sole source contract for Foot and Mouth Disease (FMD) Vaccine Antigen Concentrate (VAC) purchase, storage for the guaranteed shelf-life of the VAC, and conversion of VAC to finished vaccine upon request by the NAFMDVB. Boehringer Ingelheim is the only currently active manufacturer that satisfies the USDA APHIS Center for Veterinary Biologics (CVB) criteria for importation of vaccine derived from select FMD strains of Asian, Middle-Eastern, or African origin.

In compliance with the Animal Health Act, 7 U.S.C. 8303A, the Secretary shall have the authority to stockpile veterinary vaccines and other veterinary countermeasures (e.g. diagnostics) in preparation for select catastrophic animal diseases such as foot and mouth (FMD) disease. Commensurate with this authority, USDA seeks to stockpile FMD vaccines acting as the agent for the North American Foot and Mouth Disease Vaccine Bank (Bank), whose members consist of officers from the respective agricultural agencies of the United States, Mexico, and Canada. The goal is to stockpile sufficient FMD vaccine precursor or access to finished vaccine to supply an emergency vaccination campaign in each member country or countries until these Bank reserves are exhausted. All vaccines included in the Bank must be capable of Differentiating Infected from Vaccinated Animals (DIVA).

USDA is seeking to acquire high-potency DIVA-compatible FMD vaccines from Boehringer-Ingelheim (BI) Inc., formerly Merial Inc., of Lyon, France, that will be stored in the form of Vaccine Antigen Concentrate (VAC) and only finished into usable vaccine if there is an active outbreak of sufficient magnitude to require vaccine. The period of performance of the contract will be 5 years from delivery of VAC to the NAFMDVB. The VAC is available for conversion into finished vaccine at any time during the 5-year guaranteed shelf-life of that VAC.

3. A DESCRIPTION OF THE SUPPLIES, EQUIPMENT, OR SERVICES

REQUIRED TO MEET AGENCY NEEDS (INCLUDING THE ESTIMATED

VALUE OF THE ACQUISITION INCLUSIVE OF OPTIONS):

The supplies required are FMD vaccines in the form of VAC (long-term storage form) or finished vaccines (products ready for use). Finished vaccine may include but is not limited to antigen in suspension or lyophilized vaccine.

We are seeking a 2.5 million dose equivalent of VAC to meet immediate FY19 need. The estimated cost for the purchase of the VAC is $1,675,000.00. Should conversion to finished vaccine be needed during the life of the VAC (5 years), the conversion cost for 2.5 million doses is estimated to be $1,000,000.00.

The total estimated amount of VAC purchase and conversion to vaccine (if needed) is $2,675,000.00. This contract is meant for two purposes, to allow for the purchase of VAC for FY19 need and as a contingency to provide for the conversion of this VAC into finished in the event of an outbreak.

Ongoing VAC requirements are anticipated to be fulfilled using subsequent contracts to be awarded in FY20. This contract will not be used to purchase additional quantities of VAC.

4. IDENTIFICATION OF THE STATUTORY AUTHORITY PERMITTING

NONCOMPETITIVE ACQUISITIONS:

6.302-1 -- Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements.

5. A DEMONSTRATION THAT THE PROPOSED CONTRACTOR’S UNIQUE

QUALIFICATIONS OR THE NATURE OF THE ACQUISITION REQUIRES

USE OF THE AUTHORITY CITED:

All domestic and foreign-manufactured veterinary biologics intended for use in the United States must be pre-approved for such use by the USDA APHIS Center for Veterinary Biologics (CVB); and as previously stated, there is currently no manufacturing of commercial FMD vaccines in the United States. This limits acquisition of such products to high-quality foreign manufacturers approved by the CVB. For FMD vaccines intended for use against FMD strains of Asian, African, and Middle-Eastern origin (and in the future, South American origin), there is currently only one CVB-approved manufacturer, Boehringer-Ingelheim (BI) Inc., formerly Merial Inc., of Lyon, France. BI is the largest global exporter of high-quality and high-potency FMD vaccines and has more than a 100-year history of manufacturing this biologic. Many countries rely on BI-FMD vaccines including countries who incorporate such vaccines into their respective vaccine banks.

6. 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:

Officers of the Technical Working Group of the Bank are intimately familiar with the currently available commercial FMD vaccines and what products are in the research pipeline but are not yet commercially available.

Requirements for future FMD VAC and Vaccine will be publicized in accordance with FAR Part 6. A sources sought notice for these future contracts will be posted to ensure no new entrants to the market have become available. A previous sources sought notice posted in March of 2016 yielded additional interested vendors but none of those vendors met the CVB approval requirement and/or did not have a marketable VAC that met our requirement. Only BI currently produces the FMD VAC strain that meets our requirements for purchase under this contract.

7. A DETERMINATION BY THE CONTRACTING OFFICER THAT THE

ANTICIPATED COST TO THE GOVERNMENT WILL BE FAIR AND

REASONABLE, AND THE BASIS FOR THAT DETERMINATION:

The contracting officer has historical pricing data for this VAC and similar items across multiple manufacturers. Pricing for those historical purchases will be compared to the proposed contractor pricing. This information, combined with the Contracting Officer’s knowledge and experience will be used to determine the pricing to be fair and reasonable. Should the Contracting Officer be unable to determine fair and reasonable pricing, no award will be made.

8. A DESCRIPTION OF THE MARKET RESEARCH CONDUCTED (FAR

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

MARKET RESEARCH WAS NOT PERFORMED:

A formal effort to determine the number of eligible FMD vaccine manufacturers globally was undertaken in March 2016 when USDA issued an FMD vaccine “Sources Sought Notice” (SSN), Solicitation Number: AG-6395-S-16-0086, to canvass FMD vaccine manufacturers to determine the availability of currently manufactured commercial products. A team of impartial and disinterested Veterinary Services subject matter experts reviewed the responses to the SSN. Responses were received from six manufacturers of which 4 had currently available products for purchase (i.e., were not in the research/developmental stage); and of those four, 3 had previously received approval by CVB and only 2 manufacturers of those 3 companies had historically marketed products of Asian, African, and Middle-Eastern topotypes. Of these two remaining companies, only one company, Boehringer Ingelheim, offered FMD vaccines derived from strains originating in Asia, Africa, and the Middle-East.

This is an interim purchase for immediate need of a specific FMD VAC. To ensure any new potential manufacturers are identified prior to award of long term IDIQ contracts, a new sources sought notice will be posted. This sources sought notice is anticipated to be posted sometime prior to the end of FY19.

9. ANY OTHER FACTS SUPPORTING THE USE OF OTHER THAN FULL

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

N/A

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

INTEREST IN THE ACQUISITON:

No additional sources have expressed interest in this acquisition. Should any sources be identified during the 30 day notice of intent to sole source, they will be identified here.

11. 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:

The Technical Working Group of the Bank will continue to monitor the availability of new products including novel vaccines as they become commercially available. There is also an internal USDA APHIS Veterinary Services Countermeasures Working Group that is being formed to perform exactly this kind of market research. A Sources Sought Notice (SSN) is anticipated to be posted prior to the award of any further contracts for future FMD VAC needs. All reasonable efforts to make multiple awards for future FMD VAC needs will be made.

12. I HEREBY CERTIFY THAT THE INFORMATION PROVIDED IN THIS

JOFOC IS ACCURATE AND COMPLETETOTHE BEST OF MY

KNOWLEDGE AND BELIEF.

(Certification requires the signature of the contracting officer and program manager, and shall include the date)

Robert J. Zeglin Date Kim Dodd Date

Contracting Officer Director Minneapolis Procurement Branch Foreign Animal Disease Diagnostic

Laboratory

Plum Island, NY

7/10/2019