P03_Justification and Approvals_under 250K_770-24-3-801-0545_Redacted.pdf

VHAPM Part 813.106 Simplified Acquisi on Procedures: Solici ng from a Single Source A achment 1: Brand Name Jus fica on for SAP under the SAT

Last Updated: 02/01/22

The product is being requested to fill prescrip ons where the Physician specifically requested this brand for the veteran. Within the Veterans Health Administra on brand name drugs and medical surgical (MedSurg) products may be prescribed by physicians when in their clinical judgment the brand name drug/MedSurg will provide a be er therapeu c outcome for pa ents. 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 an cipated requirements. Prescrip ons are entered as DAW or Dispense as Wri en meaning the pharmacy is not allowed to subs tute any other brand for the prescrip on but can only fill prescrip on with the brand that was ordered by the Physician. The site is not reques ng purchase from any certain vendor. Mul ple vendors offer these items.

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

In accordance with FAR Part 10 and VAAR 810, market research has been conducted for this acquisi on. The procurement package was received by the Contrac ng Office on 05-23-24. Market research is being conducted on 05-23-24 for the upcoming acquisi on for MOUTHWASH,ORAL,MINT,BIOTENE.

A sources-sought no ce was not posted for this acquisi on because pharmaceu cal buys are rou ne, and the Contrac ng Officer is very knowledgeable about the pharmaceu cal marketplace. It is unlikely that a sources-sought no ce would produce significantly new informa on about the market. Therefore, a compe ve solicita on will be posted to the Government point of entry at SAM.gov to provide public knowledge of VA’s requirement.

A query was conducted via the Na onal Ins tutes of Health (NIH) U.S. Na onal Library of Medicine DailyMed website. The purpose of this search is to determine the country of origin (COO), and if there are any domes c sources available (both large and small business concerns in the marketplace).

The na onal drug code(s) (NDCs) 48582-0001-55 were used to query the website and resulted in 1 manufacturers who currently manufacture MOUTHWASH,ORAL,MINT,BIOTENE.

Manufacture(s):

48582-0001-55, GSK CONSUMER HEALTHCARE(U.K.), Large, COO: USA

The Contrac ng Officer conducted further searches in VetCert u lizing NAICS code 325412 and yielded a total of 130 SDVOSB/VOSBs.

Further market research was conducted via the SBA Dynamic Small Business Search database using the criteria of NAICS code 325412, business type includes Manufacturing, and firms with no more than 500 employee(s), which resulted in 33 small businesses who iden fied as authorized distributors or manufacturers. Based on procurement history of other pharmaceu cals, it is an cipated that at least two or more of the small businesses are authorized distributors capable of fulfilling VA’s requirement at a fair and reasonable price.

The Contrac ng Officer reviewed the NMR and its applicability to the procurement ac on. The nonmanufacturer rule applies to socioeconomic specific small business categories for contracts valued above the micro-purchase threshold (MPT) but does not apply to total (non-socioeconomic specific) small business set-asides below the simplified acquisi on threshold (SAT). In accordance with the Non-Manufacturer Rule as defined in 13 CFR 121.406(b), there are two or more small business concerns who iden fy themselves as

VHAPM Part 813.106 Simplified Acquisi on Procedures: Solici ng from a Single Source A achment 1: Brand Name Jus fica on for SAP under the SAT

Last Updated: 02/01/22 authorized distributors.

These small business concerns have 500 or less employees, engage in the retail wholesale trade and normally sell pharmaceu cals, take ownership or possession of the pharmaceu cal via its facili es or via its personnel.

However, market research concludes that there are presently no domes c small business concern manufacturers that exist in the commercial marketplace for the items required for this procurement.

The CO has confirmed there is no class waiver associated for pharmaceu cals under NAICS Code 325412. The Contrac ng Officer considered the use of an individual waiver, however, is not feasible due to the expedient nature of this acquisi on.

Given this informa on, a socioeconomic specific set-aside may not be feasible as vendors would not be able to comply with the NMR without a waiver of the fourth prong (13 CFR 121.406(b)(iv)).

Alterna vely, a total small business set-aside is feasible as the NMR does not apply to total small business set-asides below the SAT in accordance with 13 CFR 121.406(c).

5. Contrac ng Officer's Cer fica on: Purchase is approved in accordance with FAR13.106-1(b). I cer fy that the foregoing jus fica on is accurate and complete to the best of my knowledge and belief.

Prepared by:

McAlhaney, Michael W.

Contrac ng Officer

MICHAEL MCALHANEY Digitally signed by MICHAEL MCALHANEY Date: 2024.05.23 13:33:59 -05'00'