S02_JA_Q0322_CS_CO.pdf

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

DEPARTMENT OF VETERANS AFFAIRS

Justification for “Brand Name” Single Source Awards IAW FAR 13.106-1

For Over Micro-Purchase Threshold but Not Exceeding the SAT ($250K)

Acquisition Plan Action ID: 36C770-24-AP-0695 & 36C770-24-AP-0684

1. Contracting Activity: Department of Veterans Affairs, NCO 15, National Contracting Office. 2237 # 762-24-3-040-2359 & 762-24-3-040-2280, Tucson, CMOP – Tucson, AZ.

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

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

(1) Brand Name Specific, Pharmaceutical item (D1217: DROSPIRENONE 4MG TAB,28) listed in the above table. The proposed procurement action will be a firm-fixed-priced contract.

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)/ or specific Manufacture Part Number (MPN) 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 or MPN but 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 or perform specific function to match the product code.

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 item 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 a pharmaceutical that has been specifically identified using the National Drug Code (NDC) and name. Since the (NDC) identifies the pharmaceuitcal item prescribed for the individual patient, market research must utilize the brand specific (NDC) as the primary search criteria to ensure the correct product (i.e., ) is purchased.

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 product details and 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 was used to query the DailyMed website.

Per DailyMeds - “SLYND is a progestin indicated for use by females of reproductive potential to prevent pregnancy.”

Item is manufactured by Laboratories Leon Farma, S.A., a large business in Spain. (Photo above showing manufacter and COO information.

A search was conducted within the VetCert database to determine if there are service-disabled, veteran-owned business (SDVOSB) or a veteran-owned, small business (VOSB) who identify as manufacturers of utilizing NAICS code 325412 and yielded a total of 129 SDVOSB/VOSBs who identified as manufacturers;

however, these SDVOSB/VOSBs are distributors for large businesses. The requested NDCs manufacture was specifically searched within the database and yielded no results. There are no known SD/VOSB manufacturers for the required pharmaceutical.

Research was conducted via Dynamic Small Business search which resulted in 24 small businesses who identified as authorized distributors. The requested NDCs manufactures was specifically searched within the database and yielded no results.

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 only a few domestic small business manufacturers that exist in the commercial marketplace for some of the requested pharmaceuticals. Line items 1, and 3, which are part of the entire procurement are manufactured domestically by small businesses; however, line item 2, which is in consideration for this JnA waiver - is manufactured by a non-domestic, large businesses. The CO has confirmed there is no class waiver associated for the requested 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; furthermore, since the majority, 54% of the procurement total IGCE is manufactured by a large businesses and there are not multiple small business manufacturers to promote competition. This requirement will be solicited as a total small business set-aside. 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.

Jennifer Knight Kelley Cunningham Contract Specialist Contracting Officer

Jennifer Knight Digitally signed by Jennifer Knight Date: 2024.08.01 13:23:49 -05'00'

KELLEY

CUNNINGHAM

Digitally signed by

KELLEY CUNNINGHAM

Date: 2024.08.01 13:55:48 -05'00'