S02_JnA_Q0214.pdf

VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Brand Name Justification for SAP under the SAT

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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-0465

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

Manufacturer Country of Origin

0001 17307 ERRIN 0.35MG TAB,28

(E0586)

51862-0886-

240 BX 3 Priamal Healthcare (Small

Business)

United Kingdom

0002 3125 ESTRADIOL

(ESTROGEL) 0.06%

TRANSDERM GEL

50GM, (E0622)

17139-0617-

160 TU 50 DPT Laboratories (Large Business)

USA

0003 2502 LOW-OGESTREL TAB

28CT (L0366)

51862-0564-

96 PG 6 Mayne Pharma (Small Business)

Canada

0004 2551 NITROGLYCERIN 2%

OINT 60GM, (N0066)

00281-0326-

396 TU 60 Savage Laboratories

(Large Business)

USA

This is an individual brand name justification to support the procurement of the pharmaceuticals 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 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.

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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 March 8, 2024. Market research was conducted on April 1, 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 133 SD/VOSBs who identified as authorized distributors. Further market research was conducted via Dynamic Small Business search (DSBS) which resulted in 22 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 Market place.

The national drug codes (NDCs) listed in the above chart were used to query the DailyMed website and resulted in multiple manufacturers. The manufacturer and country of origin, as stated on the DailyMed website is listed in the table above for each pharmaceutical within the requirement.

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- 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 other than the ERRIN 0.35MG TAB, which is manufactured by Piramal Healthcare, a small business, however the product is manufactured non-domestically in the United Kingdom. LOW-OGESTREL TAB is also manufactured by small business concern, Mayne Pharma; however, this tablet is also manufactured non-domestically in Canada.

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

Last Updated: 02/01/22 Page 4 of 4 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