19AQMM25F1490_Limited Sources Justification.pdf

LIMITED SOURCES JUSTIFICATION

SECTION 1: IDENTIFICATION OF THE AGENCY AND THE CONTRACTING ACTIVITY

Department of State Contracting Activity Global Acquisition, Acquisition Management Directorate (GA/AM)

Requiring Activity Office of Logistics Management-Supply Chain Management (A/GO/OPS/SCM)

SECTION 2: NATURE AND/OR DESCRIPTION OF THE ACTION BEING APPROVED

Approval is requested to limit the number of sources for soliciting and awarding an order under a Federal Supply Schedule contract for the supplies and/or services described in Section 3 on behalf of the Requiring Activity.

Annual delivery order issued on a sole-source basis from the Department of Veteran’s Affairs GlaxoSmithKline (GSK) federal supply schedule 522193-02 for pharmaceuticals and vaccines. The specific contract number is 36F79722D0178. The delivery order will be for proprietary Fluarix and FluLaval Influenza vaccines. This is a direct procurement from the VA federal supply schedule available to government agencies and is not an inter-agency agreement. The intent is to issue a Firm-Fixed-Price (FFP) delivery order with GlaxoSmithKline for 2025-2026 Flu vaccines. The specific contract number is 36F79722D0178. The estimated order value is $635,325.00.

SECTION 3: DESCRIPTION OF SUPPLIES OR SERVICES REQUIRED TO MEET THE AGENCY’S

NEEDS

Fluarix and FluLaval Trivalent Influenza vaccines for the 2025-2026 flu season. The vaccine is required to immunize embassy personnel and family members at over 180 embassies and consulates as disease prevention against Influenza viruses caused by A subtype viruses and Type B viruses. The requirement is to provide Fluarix and FluLaval Influenza vaccines to be delivered to Dulles, VA 20166. These supplies require that cold chain storage is always maintained, which provides as an approved government receiving point. After initial delivery, the Office of Logistics Management will coordinate the timely distribution of the vaccines to embassies and consulates to ensure final delivery ahead of start of the 2025-2026 flu season.

Specific GSK products:

Flulaval Flu vaccine 0.5mL prefilled syringes, box of 10 prefilled syringes ($147.75 per pack, 300 packs requested) Fluarix Flu vaccine 0.5mL prefilled syringes, box of 10 prefilled syringes ($147.75 per pack, 4,000 packs requested)

The estimated value for the entire period of performance is $635,325.00.

SECTION 4: AUTHORITY AND SUPPORTING RATIONALE

This acquisition is conducted under the authority of the Multiple-Award Schedule Program (41 U.S.C. 152(3) and 40 U.S.C. 501), as implemented in FAR 8.405.6 by the following:

☒ FAR 8.405-6(a)(1)(i)(B) - Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized.

Fluarix FluLaval Influenza Vaccines for the 2025-2026 Flu season are proprietary annual Flu vaccines developed and manufactured by GlaxoSmithKline (GSK). GSK is the only manufacturer of Fluarix and Flulaval Influenza vaccines for ages 6 months and older.

SECTION 5: DETERMINATION BY THE ORDERING ACTIVITY CONTRACTING OFFICER THAT THE

CONTRACT ACTION REPRESENTS THE BEST VALUE CONSISTENT WITH FAR 8.404(D)

The Contracting Officer has determined the anticipated contract action will represent the best value based on the Contracting Officer’s plan to follow the procedures in FAR 8.405. Although approval is requested to contract with one source, the Contracting Officer will not award the planned contract action unless the Contracting Officer evaluates and determines that the resultant price is reasonable.

SECTION 6: DESCRIPTION OF THE MARKET RESEARCH CONDUCTED AMONG SCHEDULE

HOLDERS AND THE RESULTS OR A STATEMENT OF THE REASON MARKET RESEARCH WAS

NOT CONDUCTED

A/GO/OPS conducts regular pharmaceutical market research, and GlaxoSmithKline is the only manufacturer that makes the Fluarix and FluLaval Influenza vaccines. These vaccines prevent against four major Influenza viruses. These specific vaccines are the first Quadrivalent vaccines approved by the FDA for use and distribution.

SECTION 7: STATEMENT OF THE ACTIONS, IF ANY, THE AGENCY MAY TAKE TO REMOVE OR

OVERCOME ANY BARRIERS THAT LED TO THE RESTRICTED CONSIDERATION BEFORE ANY

SUBSEQUENT ACQUISITION FOR THE SUPPLIES OR SERVICES IS MADE

Federal agencies order annual influenza vaccines through the VA federal supply contract vehicle. Specific vaccines are issued by manufacturer/vendors on an annual basis. A/GO/OPS/RLC/SCM will continue to monitor market conditions, products, and new federal supply schedule related products.

SECTION 8: CERTIFICATIONS

TECHNICAL AND REQUIREMENTS CERTIFICATION (FAR 6.303-2(b)) I certify that the facts and representations under my cognizance which are included in this Justification and its supporting acquisition planning documents, except as noted herein, are complete and accurate to the best of my knowledge and belief.

Technical and Requirements Cognizance:

Title: HELP Program Manager Requiring Office: A/GO/OPS/SCM

CONTRACTING OFFICER CERTIFICATION (FAR 6.303-2(a)(12)) I certify that this submission is accurate to the best of my knowledge, and that it contains complete information necessary to enable other officials to make an informed recommendation for approval or disapproval.

Contracting Officer Office: GA/AM/TSS/T&L

SECTION 9: APPROVALS

Division Director Office: GA/AM/TSS/T&L