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VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Single Source Justification for SAP under the SAT Last Updated: 02/01/22 Page 1 of 2 DEPARTMENT OF V... VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Single Source Justification for SAP under the SAT Last Updated: 02/01/22 Page 1 of 2 DEPARTMENT OF VETERANS AFFAIRS Justification for Single Source Awards IAW FAR 13.106-1 For Over Micro-Purchase Threshold but Not Exceeding the SAT ($250K) Acquisition Plan Action ID: 36C770-23-AP-0062 Contracting Activity: Department of Veterans Affairs, VISN 15, Consolidated Mail Outpatient Acquisitions (CMOP) 2237: 765-23-715-0009 Brief Description of Supplies/ Services required and the intended use/Estimated Amount: This procurement is for pharmaceutical supplies in accordance with FAR 13.5 Simplified Procedures for Certain Commercial Items and specifically FAR 13.501 Special Documentation Requirements, where acquisitions conducted under Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6, but still require a justification using the format of FAR 6.303-2. The proposed procurement action will be for a new firm-fixed price contract for pharmaceuticals. This is an individual brand-name justification to support the procurement of the pharmaceutical item is listed below. The value for the required pharmaceutical is $120,537.20. Items are to be delivered 5 days ARO. NDC 00173-0681-22 RELENZA 5MG DISKHALER Lot #SE5H Last Lot Expiration Date April, 2026 Country of Origin: UK, Ireland, Singapore Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: Only one responsible source, GlaxoSmithKline (GSK) LLC, and no other, will satisfy agency requirements. GSK manufacturers two NDC s for the brand-name Relenza: NDC 00173-0681-01 - Commercial Relenza on FSS at $ per unit. NDC 00173-0681-22 - Strategic National Stockpile, not on FSS, and sold strictly for stockpile purposes, at a reduced priced, and for government entities. The price is $ per unit, non refundable, and purchased directly from GSK. This is the NDC that will be procured. Additionally, products have been prescribed for patients by VA Physicians. Pharmacy employees do not have the training and/or the authority to countermand physician orders. Brand Specific products are the same thing as dispense and written on a physician s prescription. No National Drug Code (NDC) substitutions are permitted. In the VA, Pharmacy Benefits Management (PBM) has determined that CMOP IDs in the National Drug Fine (NDF) will most always identify brand specific products int eh VA PRINT NAME. This is not always inclusive where a particular NDC has been determined to be formulation specific by clinical evaluation performed by the PBM or in the case where only one product in the marketplace has been identified to contain the specific ingredients to match the product code. Description of market research conducted and results or statement why it was not conducted: Market research, in accordance with FAR Part 10, was conducted of the proposed acquisition; however, nonmanufacturer requirements apply and the VIP database search concluded there are no known SDVOSB or VOSB manufacturers of the above referenced pharmaceutical items for NAICS code 325412. Therefore, the Rule of Two cannot be met and no set-aside solicitation is feasible. As previously stated, only one responsible source, GlaxoSmithKline (GSK) LLC, and no other, will satisfy agency requirements. Contracting Officer's Certification: Purchase is approved in accordance with FAR13.106-1(b). I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief. CHRISTY PENDLAY Digitally signed by CHRISTY PENDLAY Date: 2022_.12.20 13:16:28 -06'00' CHRISTY PENDLAY Date CONTRACTING OFFICER NCO 15 CONTRACTING, CMOP DIVISION