P03.JA final.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-0095

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

2237 # 760-23-3-050-1076, Leavenworth CMOP, Leavenworth, KS.

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

Item Number Description NDC Quantity

Unit of Measure

Packaging Multiple

0001 CASTOR OIL 60ML (C0109) 00395-0515-92 216 BT 60

CALCIUM

119MG/MAGNESIUM 71.5MG

EC TAB 60CT (C1517) 67618-0107-60 504 BT 60

DIMETHICONE 3% LOTION

120ML (D0538) 53229-0775-04 144 BT 120

FEXOFENADINE 60/PSEUDO

120MG SA TAB 20CT,F0173 41167-4310-04 192 CT 20

0005 PSYLLIUM SF ORAL PWD PKT 370000-0024-04 216 BX 30

PETROLATUM (WHITE) OINT

30GM, P0700 53329-0068-01 144 TU 30

SODIUM CHLORIDE NASAL GEL

15ML, S0942 00225-0525-47 1152 EA 15

STRIPS, NASAL, BREATHE

RIGHT,LG,30'S,XT103

10071-0800-07

NAME BRAND ONLY 648 BX 30

ZINC OXIDE 40% TOP PASTE

(Z0109) 74300-0000-71 1440 TU 120

This is an individual brand name justification to support the procurement for 1 of 9 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

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

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.

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.

Product was searched for in the National Acquisition Center (NAC) database for existing Federal Supply Schedule (FSS) or Prime Vendor (PV) contracts. This search yielded no results. A Request For Information (RFI) was considered; however, it was determined not appropriate for this requirement as the length of time required to process and handle prescriptions has a very short lead time and delays in awarding contracts cause undue hardships for prescription fulfillment. 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 Small Business Administration Veteran 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 35 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. Because the Non-Manufacturer Rule (NMR) and the Limitations on Subcontracting (LOS) clause apply to all SD/VOSB set asides (and sole sources) regardless of the dollar value, a SD/VOSB set-aside is not feasible. A SD/VOSB set-aside is not feasible as the Non-Manufacturer Rule (NMR) and the Limitations on Subcontracting (LOS) require the contractor to supply the product of a small business or an offeror must either manufacture the item in accordance with the Limitations on Subcontracting or supply the product of a small business made in the United States. An SDVOSB concern would need to prove they are a manufacturer or are providing the products of a small business manufacturer to be eligible for award of a contract or the CO would have to obtain an approved individual waiver to the NMR through the Small Business Administration (SBA). As stated above, no small business manufactures this item and the SBA has not granted a Non-Manufacturer class waiver for the requested med/surg item and due to the urgency and risk to patient safety we do not have time to request and receive approval for and NMR waiver to set-aside for SDVOB’s. This does not preclude a SD/VOSB from quoting and/or receiving and award as a small business. 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

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

Kayla Powers Contract Specialist

Justin B. Smith Contracting Officer

KAYLA

POWERS

Digitally signed by KAYLA

POWERS

Date: 2023.06.07 16:37:38 -05'00'

JUSTIN SMITH Digitally signed by JUSTIN SMITH Date: 2023.06.14 13:44:52 -05'00'