S02.JnA Q0230.pdf

VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Brand Name Justification for SAP under the SAT

Last Updated: 02/01/22 Page 1 of 2

DEPARTMENT OF VETERANS AFFAIRS

Justification for Brand Name Awards IAW FAR 13.106-1 For

Over Micro-Purchase Threshold but Not Exceeding the SAT ($250K)

Acquisition Plan Action ID: 36C770-23-AP-0504

1. Contracting Activity: Department of Veterans Affairs, Network Contracting Office 15, CMOP Division. 2237 # 760-23-3-050-0824, Leavenworth CMOP, Leavenworth, KS.

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

Item Number

File Number

(IMF)

Description NDC Quantity Unit of Measure

Packaging Multiple

0001 11492 CLOMIPHENE CITRATE

50MG TAB 30CT, C0482

0713- 0885-30

1752 BT 30

This is an individual brand name justification to support the procurement of the pharmaceutical items in the table above. The proposed procurement action will be a firm-fixed-price contract award for the supplies.

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

Product has 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 “dispense as 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 File (NDF) will most always identify “brand specific” products in the 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.

VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Brand Name Justification for SAP under the SAT

Last Updated: 02/01/22 Page 2 of 2

Description of market research conducted and results or statement why it was not conducted: In accordance with FAR Part 10, VAAR 810, market research has been conducted for this acquisition.

The Government is not allowed to do business using wholesale trade or retail trade NAICS codes, searches must be conducted using the manufacturer NAICS code 325412, pharmaceutical preparation manufacturing. A Veterans Small Business Certification (VetCert) search identified 126 potential SDVOSB and VOSB’s as capable vendors. An inquiry of the SBA Dynamic Small Business (DSBS) database produced 4 small businesses. Despite these results there are no known SDVOSB, VOSB, HUBZone, 8(a), or small business organizations that manufacture the required items. These vendors are not manufacturers, but they are distributors for large business wholesalers. Based on this research and policy, the rule of two cannot be met to set the procurement aside for a socioeconomic subcategory of small business; however, in accordance with 13 Code of Federal Regulations (CFR) § 121.406(c) the Nonmanufacturer Rule (NMR) and limitations on subcontracting, CFR § 125.6, do not apply for acquisitions under $250K; therefore, a small business set-aside is feasible. This procurement will be solicited as a small business set-aside; and a pre-solicitation contracting opportunity was posted to SAM.gov.

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.

Kayla Taylor Date Contract Specialist

Justin B. Smith Date Contracting Officer

KAYLA TAYLOR

Digitally signed by KAYLA

TAYLOR

Date: 2023.04.11 11:37:46 -05'00'

JUSTIN SMITH

Digitally signed by JUSTIN

SMITH

Date: 2023.04.12 07:42:19 -05'00'