P03_Justification and Approvals_under 250K_770-24-1-801-0010_Redacted.pdf

VHAPM 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 provide a better therapeutic outcome for patients. Brand name drugs and MedSurg are requested when there is a clinical requirement for the drug/product or there is history of clinical requirements for the drug/product and inventory must be maintained to meet anticipated requirements. Prescriptions are entered as DAW or Dispense as Written meaning the pharmacy is not allowed to substitute any other brand for the prescription but can only fill prescription with the brand that was ordered by the Physician. The site is not requesting purchase from any certain vendor. Multiple vendors offer these items.

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

The Consolidated Mail Outpatient Pharmacy (CMOP) has identified that this pharmaceutical is not available from mandatory sources (e.g., prime vendor) and, therefore, has submitted the acquisition to Network Contracting Office (NCO 15) which provides acquisition support to CMOP.

This acquisition is for medication/pharmaceuticals that have been specifically identified using National Drug Codes (NDCs) which is a unique, 3-segment numeric identifier assigned to each medication listed under Section 510 of the U.S. Federal Food, Drug and Cosmetic Act. NDCs are universal product identifiers that incorporate the manufacturer/packager of the medication/pharmaceutical

Acceptable National Drug Codes (NDCs): 48582-0001-55

In accordance with FAR Part 10 and VAAR 810 market research was conducted. The procurement package was received on 07-25-23.

Market research is being conducted on 08-16-23 for the upcoming acquisition for MTHWASH, ORAL

MOIST,1.5 BIOTENE.

A sources sought notice was not posted for this acquisition because pharmaceutical buys are routine, and the Contracting Officer is very knowledgeable about the pharmaceutical marketplace. It is unlikely that a sources-sought notice would produce significantly new information about the market. Therefore, a competitive solicitation will be posted to the Government point of entry at SAM.gov to provide public knowledge of VA’s requirement.

This is for pharmaceuticals that have been specifically identified using National Drug Codes (NDCs), or Stock Keeping Units (SKUs) which are unique product identifiers.

Using the acceptable NDC/SKUs, the National Institutes of Health (NIH) U.S. National Library of Medicine DailyMed website and CMOP Medication Image Library (MIL) Data and Images website were queried to determine the manufacturers of the acceptable items to assist in establishing the size, socioeconomic status, and domestic availability for each item.

The national drug code(s) (NDCs) 48582-0001-55 were used to query the website and resulted in 1 manufacturers who currently manufacture MTHWASH,ORAL MOIST,1.5 BIOTENE.

Cross-referencing the NIH and MIL information with databases Duns & Bradstreet, SAM.gov, the Small Business Administration’s VetCert, DSBS and/or other search engines (e.g., Google, U.S. Securities and

VHAPM 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

Exchange Commission’s EDGAR), the manufacturers of the requested pharmaceutical(s) have been determined large business concerns or could not be confirmed as Small Businesses on the SBA website.

Manufacture(s):

48582-0001-55, GSK CONSUMER HEALTHCARE(U.K.), Large, COO: USA Product may be domestically available

Because the Government is not allowed to do business using Wholesale Trade or Retail Trade NAICS codes, searches must be conducted using manufacturer NAICS codes.

Market research was conducted through VetCert under NAICS 325412(Pharmaceutical Preparation Manufacturing).

This search resulted in 2 or more SDVOSB companies doing business using this NAICS code. Despite these results, there are no known SDVOSB, VOSB, HUBZone, 8(a), or small business organizations that manufacture the items required for this procurement.

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 these items and SBA has not granted a non-manufacturer class waiver for pharmaceuticals. These requirements apply to all SD/VOSB set asides regardless of dollar value. Due to the urgency and risk to patient safety we do not have time to request and receive approval for an NMR waiver to set-aside for SDVOSB’s.

Based on this research and policy, the VA Rule of Two cannot be met to set the procurement aside for SD/VOSB contractors. Although we cannot set-aside to SDVOSB due to the NMR and LOS, this does not preclude a SD/VOSB from quoting and/or receiving an award as a small business

Based on the exception to the NMR for acquisitions under $250K, a small business set-aside is feasible.

Contracting Officer requesting a(n) SMALL BUSINESS/Small Business procurement, to a(n) Open Market Vendor.

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.

Prepared by:

McAlhaney, Michael W.

Contracting Officer

MICHAEL MCALHANEY Digitally signed by MICHAEL MCALHANEY Date: 2023.08.16 14:09 09 -05'00'