P03.JA.Q0368_signed.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 3

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-0844

1. Contracting Activity: Department of Veterans Affairs, Network Contracting Office 15, CMOP Division.

2237 # 760-23-4-050-1280 , Leavenworth CMOP, Leavenworth, KS.

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

Item Number IMF Description NDC QTY

Unit of Measure

Packaging Multiple

0001 19282

LITHIUM CARBONATE

600MG CAP 100CT (L0099) 68462-0222-01 336 BT 100

0002 3103

LACTULOSE 20GM/PK

PWDR--L0243 66220-0729-30 84 BX 30

0003 4524

MINOCYCLINE HCL 100MG

CAP 500CT, M0102 63304-0696-05 96 BT 500

0004 13880

MIRTAZAPINE 30MG

DISINTEGRATING TAB 30CT,

M0547 57237-0012-06 250 BT 30

0005 10382

MICROGESTIN 1/20 TAB, 21

M0678 NAME BRAND ONLY 51862-0868-06 120 CT 6

0006 5861

PILOCARPINE HCL 1% OPH

SOLN 15ML, P0060 70069-0181-01 144 EA 15

0007 5860

PILOCARPINE HCL 2% OPH

SOLN 15ML (P0062) 70069-0191-01 36 EA 15

0008 2400

POTASSIUM ACID

PHOSPHATE 500MG TAB--

P0656 00486-1111-01 168 BT 100

This is an individual brand name justification to support the procurement of line item 5 MICROGESTIN 1/20 TAB, 21 M0678 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

Last Updated: 02/01/22 Page 2 of 3

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.

4. 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 129 potential SDVOSB and VOSB’s as capable vendors. An inquiry of the SBA Dynamic Small Business (DSBS) database produced 36 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.

5. 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.

Last Updated: 02/01/22 Page 3 of 3

Kayla Powers Contract Specialist

Justin B. Smith Contracting Officer

KAYLA

POWERS

Digitally signed by KAYLA

POWERS

Date: 2023.07.19 09:33:19 -05'00'

JUSTIN SMITH

Digitally signed by JUSTIN

SMITH

Date: 2023.07.19 11:45:27 -05'00'