S02_JnA_Q0431.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: 36C770-23-AP-0936

Contracting Activity: Department of Veterans Affairs, NCO 15, National Contracting Office.

2237 # 760-23-4-050-1468, Leavenworth CMOP, Leavenworth, KS

Brief Description of Supplies/ Services required Item

Number IMFN Description NATIONAL STOCK NUMBER Quantity Unit of

Measure Packaging Multiple

0001 13366 ROPINIROLE HCL 12MG SA TAB 30CT (R0257) 55111-0728-30 1500 BT 30

0002 13913 RISPERIDONE 0.5MG TAB 500CT (R0112) 27241-0003-50 240 BT 500

0003 9147 SULFACETAMIDE NA 10%/SULFUR 5% TOP FOAM 60GM, S0530 42192-0143-60 144 BT 60

0004 6202 THYROID 180MG TAB 100CT (T0050) (BRAND NAME) 00456-0462-01 96 BT 100

0005 16486 TEMOZOLOMIDE 100MG CAP 5CT, T0475 16729-0050-53 420 BT 5

This is an individual brand name justification to support the procurement of the one (1) Brand Name Specific pharmaceutical item (THYROID 180MG TAB 100CT) in the above table (line item: 4 is the only Brand Name item being requested). The proposed procurement action will be a firm-fixed-priced contract.

Per DailyMeds product indications and usage:

Per DailyMeds - Armour® Thyroid tablets are indicated: As replacement or supplemental therapy in patients with hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis.

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 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: Single Source Justification for SAP under the SAT

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

o 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 the pharmaceutical supply that has been specifically identified using the National Drug Code (NDC) and name. The station requested the brand name NDC for THYROID 180MG TAB 100CT (00456-0462-01).

o A query was conducted, via the National Institutes of Health (NIH) U.S. National Library of Medicine/ DailyMeds 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 code(s) (NDC) 00456-0462-01 was used to query the website and resulted in Allergan as the manufacturer who currently manufacture THYROID 180MG TAB 100CT. The manufacturer Allergan manufactures its product domestically in the USA.

The Contracting Officer conducted searches in VETCERT to determine if there are service-disabled, veteran-owned business (SDVOSB) or a veteran-owned, small business (VOSB) who identify as manufacturers utilizing NAICs code: 325412 and this yielded a total of (132) SDVOSB/VOSBs who are registered as doing business under NAICs code:

325412. The brand specific manufacturer was searched and this yielded no results.

Attachment 1: Single Source Justification for SAP under the SAT

Market research was conducted via Dynamic Small Business search which resulted in

(70) small businesses who are registered as doing business under NACICs Code: 325412.

The brand specific manufacturer was searched and this 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 no domestic small business concern manufacturers that exist in the commercial marketplace for the pharmaceutical. 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.

The Contracting Officer 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.

Cross-referencing the DailyMeds information with databases SAM.gov, the Small Business Administration’s VetCert, and/or other search engines (e.g., Google, U.S.

Securities and Exchange Commission’s EDGAR), the manufacturer of the requested pharmaceutical (Allergan) has been determined to be a Large Business Concern.

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 Contract Specialist

J. Braden Smith Contracting Officer

JENNIFER

KNIGHT

Digitally signed by JENNIFER

KNIGHT

Date: 2023.09.13 15:42:02 -05'00'

JUSTIN

SMITH

Digitally signed by

JUSTIN SMITH

Date: 2023.09.14 08:08:47 -05'00'