S02_JnA_Q0332.pdf

Pharmaceutical Item 36C77024Q0332 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: 36C770-24-AP-0599/0604

1. Contracting Activity: The Department of Veterans Affairs, Network Contracting Office (NCO) 15 – Consolidated Mail Outpatient Pharmacy (CMOP) Division on behalf of the Leavenworth CMOP.

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

0014 10382 MICROGESTIN 1/20

TAB, 21 - 6CT

(M0678)

51862-0868-

180 CT 6

0015 12467 MICROGESTIN 1.5/30

TAB,21 -6CT,

(M0874)

51862-0872-

84 BX 6

This individual brand name justification is to support the procurement of the Microgestin tablets listed below in the above table. The proposed procurement action will be a firm-fixed price contract award for the pharmaceuticals. Line items 14 and 15, Microgestin tablets, are the only product in this requirement that have a brand name requirement. Items are to be delivered 10 days after receipt of order.

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.

Attachment 1: Brand Name Justification for SAP under the SAT

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

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 procurement packet was received on April 24, 2024. Market research was conducted beginning July 11, 2024, for the upcoming acquisition.

A sources sought notice was not posted for this acquisition because pharmaceutical buys are routine, and the Contracting Officer is very knowledgeable about the 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.

Market research confirmed that these pharmaceuticals are not available from typical contract vehicles or supply chains. All avenues have been exhausted by CMOP via searches on Prime Vendor, NAC and FSS; an open market procurement is the only option that remains for purchasing these pharmaceuticals. This requirement is not for lack of planning, but due to inventory not being available via normal supply chains.

The Contracting Officer conducted further searches in VetCert utilizing NAICS code 325412, Pharmaceutical Preparation Manufacturing, and yielded a total of 128 SD/VOSBs who identified as authorized distributors. Further market research was conducted via Dynamic Small Business search (DSBS) which resulted in 24 small businesses who identified as authorized distributors.

A query was conducted via the National Institutes of Health (NIH) U.S. National Library of Medicine DailyMed website. The purpose of this search is to determine if there are any domestic sources available (both large and small business concerns) in the marketplace.

The national drug codes (NDCs) listed in the above chart in Section 2 were used to query the DailyMed website and resulted in Mayne Pharma, a large business concern, as the manufacturer for the Microgestin tablets. The items are both manufactured in China.

The Contracting Officer reviewed the Non-Manufacturer Rule and its applicability to the procurement action. The nonmanufacturer rule applies to socioeconomic specific small business categories for contracts valued above the micro-purchase threshold, but does not apply to total (non-socioeconomic specific) small business set-asides below the SAT. In accordance with the Non-

Attachment 1: Brand Name Justification for SAP under the SAT

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

Manufacturer Rule as defined in 13 CFR 121.406(b), there are two or more small business concerns who identify themselves as authorized distributors. These small business concerns have 500 or less employees, engage in the retail wholesale trade and normally sell pharmaceuticals, take ownership or possession of the pharmaceutical via its facilities or via its personnel. However, market research concludes that there are presently no domestic small business concern manufacturers that exist in the commercial marketplace for the pharmaceuticals. The CO has confirmed there is no class waiver associated for pharmaceuticals under NAICS Code 325412. The Contracting Officer considered the use of an individual waiver, however, is not feasible due to the expedient nature of this acquisition.

Given this information, 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. Alternatively, a total small business set-aside is feasible as the NMR does not apply to total small business set-asides below the SAT. This does not preclude a SD/VOSB from quoting and/or receiving an award as a small business.

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.

Kelley Cunningham Date Contracting Officer Network Contracting Office 15, CMOP Division