S02_JA_Q0071_CS_CO__Redacted.pdf

Revision: 02 Page 1 of 3 Effective Date: 12/30/2025 Acquisition ID# 36C770-26-AP-0238

DEPARTMENT OF VETERANS AFFAIRS

Justification for “Brand Name” Single Source Awards IAW FAR 12.102 For

Over Micro-Purchase Threshold but Not Exceeding the SAT

Acquisition Plan Action ID: 36C770-26-AP-0191

1. Contracting Activity: Department of Veterans Affairs, NCO 15, National Contracting Office, Leavenworth CMOP, Leavenworth, KS. 2237 #760-26-1-050-

2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount:

This is an individual brand name justification to support the procurement of two (2) Brand Name Specific Med/Surg items (Lifescan, ONE TOUCH ULTRA (GLUCOSE) TEST STRIPS in 100CT & 50CT) in the above table. The proposed procurement action will be a firm-fixed-price contract awarded for the supplies with an estimated cost of

Per the OEM, products – “Only Works with OneTouch Ultra 2 Meter: These blood glucose test strips are compatible with the OneTouch Ultra 2 meters. With a large, backlit display screen and readings in just five seconds, this blood glucose monitoring system is designed to help you manage blood glucose.

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Acquisition ID# 36C770-26-AP-0238

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used:

Products have been prescribed for patients by VA Physicians. Pharmacy employees do not have the training and/or authority to countermand physician orders. Brand Specific products are the same thing as dispensing as written on a physician’s prescription. No National Drug Code (NDC)/ or specific Manufacture Part Number (MPN) substitutions are permitted. In the VA, Pharmacy Benefits Management (PBM) has determined that CMOP National Drug File (NDF) will most always identify brand specific products in the VA PRINT NAME. This is not always inclusive where a particular NDC and or MPN 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 specific ingredients to match the product code.

4. Description of market research conducted and results or statement why it was not conducted:

Market Research Methods/Techniques/Sources: In accordance with FAR Part 10 and VAAR 810, market research has been conducted for this acquisition.

A Request for Information (RFI) was posted on December 16, 2025, seeking input from domestic manufacturers, both large and small, regarding their capability to supply the required med/surg items. No viable responses were received. Based on this outcome, it has been concluded that no domestic manufacturer currently exists that are capable of supplying the requested med/surg items.

Market research confirmed that the med/surg products are not available from typical contract vehicles or supply chains. All avenues have been exhausted by CMOP via searches on Prime Vendor, NAC, and FSS; an open market procurement is the only option that remains for purchasing the med/surg products. This requirement is not for lack of planning, but due to inventory not being available.

A query was conducted via the National Institutes of Health (NIH) U.S. National Library of Medicine DailyMed website. The purpose of this search is to determine if there are any domestic sources available (both large and small business concerns in the marketplace). The items were searched, and no results were found. Generally, Medical/Surgical items do not generate on the DailyMeds site.

The CMOP Medication Image Library along with the manufacturer’s website were searched and it was determined that Lifescan, Inc, a large business, is the manufacturer of the requested - ONE TOUCH ULTRA (GLUCOSE) TEST STRIPS in

100CT & 50CT).

The IMFNs were then used within the VISTA database to review past procurements.

After reviewing the last procurement in VISTA and getting contract numbers; FPDS

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Acquisition ID# 36C770-26-AP-0238 was reviewed and determined that per the last procurements that the products are manufactured in the United Kingdom.

The Contracting Specialist conducted searches in SBA Dynamic Vet search to determine if there are service-disabled, veteran-owned small business (SDVOSB) or a veteran-owned, small business (VOSB) who identify as manufacturers utilizing NAICS code: 325413. This yielded a total of 2 SD/VOSBs who identified as manufacturers; however, these SD/VOSBs are distributors for large businesses.

Furthermore, a search was conducted via SBA Dynamic Small Businesses (SB) who identify as manufacturers utilizing NAICS code 325413 and yielded a total of 12 SBs who identified as manufacturers. However, these SBs are distributors for large businesses. There are no SBs manufacturers for the required med/surg item. The manufacture Lifescan, Inc. was specifically searched within the SBA Dynamic Small Businesses database, this yielded no results.

A search was conducted via SAM.gov – which resulted in Lifescan, Inc. registered as a large business.

The Contracting Officer reviewed the Non-Manufacturer Rule (NMR). In accordance with the NMR as defined in 13 CFR § 121.406, the requirement that a non-manufacturer supplies the product of a small business concern is referred to as the NMR. In order to qualify as a small business concern for a small business set-aside, an offeror must either manufacture the item in accordance with the Limitations on Subcontracting (see FAR section 52.219-14, 52.219-27 and 13 C.F.R. § 125.6) or supply the product of a small business made in the United States. There is an existing NMR Class Waiver for NAICS 325413 that covers the diabetic test strips in this requirement. The Class waiver was posted to the Federal Register in 85 Fed.

Reg. 43634 on July 17, 2020. The current list of NMR Class Waivers is maintained by the SBA and can be found at non-manufacturer rule class waiver list | U.S. Small Business Administration (sba.gov). Based on the market research conducted, the CO determined there is a reasonable expectation that quotes would be received from two (2) or more SDVOSBs that can comply with the NMR.

5. Contracting Officer's Certification: Purchase is approved in accordance with FAR

PART 12. I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Sarah Fry Jennifer Knight Contract Specialist Contract Officer

SARAH FRY

Digitally signed by

SARAH FRY

Date: 2026.01.08 11:36:39 -06'00'

Jennifer Knight

Digitally signed by Jennifer Knight Date: 2026.01.14 10:26:57 -06'00'