GSAR 538 Limiting_Sources_Justification_OVER_SAT.pdf

GSAR 538.7104-3 Sole Source Justifications Page 1 of 3

Acquisition ID#: 36C252-27-AP-0570

LIMITED SOURCES JUSTIFICATION

ORDER >SAT

GSAR 538.7104-3

Acquisition Plan Action ID: 36C252-27-AP-0570

(1) Contracting Activity: Department of Veterans Affairs, Network Contracting Office 12, located at 115

South 84th Street, Suite 101, Milwaukee, WI 53214-1476, in support of VISN 12 VA Health Care

System, Captain James A. Lovell Federal Healthcare Center located at 3001 Green Bay Road, North

Chicago, IL 60064. 2237: 556-27-1-7421-0001

(2) Description of Action: 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). The action being reviewed and approved is for an VA NAC FSS Delivery Order for the Japanese Encephalitis Virus Vaccine (PF) INJ, SUSP (IXIARO

6MCG), NDC: 42515-0002-01.

Order against: FSS Contract Number: 36F79725D0249

Name of Proposed Contractor: Valneva USA, Inc.

Street Address: 4550 Montgomery Ave Ste 460

City, State, Zip: Bethesda, MD 20814-3304

Phone: 833-403-8778

(3) Description of Supplies or Services: The estimated value of the proposed action is $787,392.00.

IXIARO is a vaccine indicated for active immunization for the prevention of disease caused by the

Japanese encephalitis virus (JEV). IXIARO is approved for use in individuals 2 months of age and older.

Japanese encephalitis is a disease caused by the mosquito-borne JEV. IXIARO acts by inducing antibodies that neutralize live JEV.

JEV is the most common vaccine-preventable cause of encephalitis in Asia, occurring throughout most of

Asia and parts of the western Pacific. The area of transmission of JE virus has expanded in recent years, most notably in Australia, with widespread areas of transmission detected during 2021–2022.

Japanese Encephalitis Virus Vaccine (PF) INJ, SUSP (IXIARO 6MCG), NDC: 42515-0002-01 is required for Navy recruits prior to shipping out for training. The Centers for Disease Control (CDC), Advisory Committee on Immunization Practices (ACIP) recommends JE vaccine for people moving to a

JE-endemic country, longer-term (e.g., ≥1 month) travelers to JE-endemic areas, and frequent travelers to

JE-endemic areas. Consider JE vaccine for shorter-term (e.g., <1 month) travelers with an increased risk for JE based on planned travel duration, season, location, activities, and accommodations.

(4) Identify the Authority and Supporting Rationale (see below and if applicable, a demonstration of the proposed contractor’s unique qualifications to provide the required supply or service.

GSAR 538.7104-3 Sole Source Justifications Page 2 of 3

GSAR 538.7104-3(b)(1)(i): An urgent and compelling need exists and following the ordering procedures would result in unacceptable delays:

GSAR 538.7104-3(b)(1)(ii): 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;

GSAR 538.7104-3(b)(1)(iii): In the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original order must not have been previously issued under sole source or limited source procedures.

GSAR 538.7104-4: Items peculiar to one manufacturer:

A patent, copyright or proprietary data limits competition. The proprietary data is:

Japanese Encephalitis Virus Vaccine (PF) INJ, SUSP (IXIARO 6MCG), NDC: 42515-0002-01 is manufactured by Valneva Scotland Ltd. in Livingston, Scotland and distributed by Valneva USA, Inc. located in Bethesda, MD. The vaccine is available via the Pharmaceutical VA NAC FSS contract 36F79725D0249, with Valneva USA, Inc. IXIARO is the only JE vaccine licensed and available for use in the United States.

These are “direct replacements” parts/components for existing equipment.

The material/service must be compatible in all aspects (form, fit and function) with existing systems presently installed/performing.

(5) Describe Why You Believe the Order Represents the Best Value consistent with GSAR 538.7102-

2(b)(4) to aid the contracting officer in making this best value determination:

Per the CDC other JE vaccines are manufactured and used in other countries but are not licensed for use in the United States. The VA NAC has determined the price to be fair and reasonable. The ordering activity has concluded that the order represents the best value and results in the lowest overall cost alternative (considering price, special features, administrative costs, etc.) to meet the Government’s needs. Additional discounts will be sought before placing the order.

(6) Describe the Market Research Conducted among schedule holders and the results or a statement of the reason market research was not conducted.

The Japanese Encephalitis Virus Vaccine (PF) INJ, SUSP (IXIARO 6MCG), NDC: 42515-0002-01 is a commercial product available on an existing governmentwide contract. Therefore, limited market research was conducted.

The U.S. Food & Drug Administration website was reviewed at https://www.cdc.gov/yellow-book/hcp/travel-associated-infections-diseases/japanese-encephalitis.html and the Centers for Disease

Control website was reviewed at https://www.cdc.gov/yellow-book/hcp/travel-associated-infections-diseases/japanese-encephalitis.html.

(7) Any Other Facts Supporting the Justification: None https://www.cdc.gov/yellow-book/hcp/travel-associated-infections-diseases/japanese-encephalitis.html

GSAR 538.7104-3 Sole Source Justifications Page 3 of 3

(8) A 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:

Alternative vaccines will continue to be reviewed prior to future purchases of IXIARO.

(9) Requirements Certification: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge. I understand that processing of this limited sources justification restricts consideration of Federal Supply Schedule contractors to fewer than the number required by GSAR Subpart 538.71. (This signature is the requestor’s supervisor, fund control point official, chief of service or someone with responsibility and accountability.)

Name: Euriel Wagner Title: Deputy Chief Supply Chain Officer Service Line/Section: Facility Support/SCM Facility: 556 Capitan James A Lovell FHCC

(10) Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

a. Contracting Officer’s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Stacy Massey

Contracting Officer

Network Contracting Office 12

b. One Level Above the Contracting Officer (Required over the SAT but not exceeding $900K): I certify the justification meets requirements for other than full and open competition.

Parris Weidenbach

Branch Chief, Supply Team

Network Contracting Office 12 https://dvagov.sharepoint.com/sites/VHAProcurement/VHAPM2/VHAPM_Part_806.3.aspx https://dvagov.sharepoint.com/sites/VHAProcurement/VHAPM2/VHAPM_Part_806.3.aspx