S02_Brand_Name_JnA_Q0409_allsigned.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-0795

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

2237 # 760-23-3-050-1219, Leavenworth CMOP, Leavenworth, KS

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

Item

Number

ITEM MASTER

FILE NUMBER Address2 Description

NDCs All BRAND NAME ONLY Quantity

Unit of Measure

Packaging Multiple

0001 6201 VA CMOP Leavenworth - 760 THYROID 120MG TAB 100CT (T0048) 00456-0461-01 432 BT 100 0002 6205 VA CMOP Leavenworth - 760 THYROID 15MG (1/4 GRAIN) TAB 100CT (T0750) 00456-0457-01 576 BT 100 0003 6206 VA CMOP Leavenworth - 760 THYROID 30-32.5MG (1/2 GRAIN) TAB 100CT (T0751 00456-0458-01 576 BT 100

This is an individual brand name justification to support the procurement of the one (3) Brand Name Specific pharmaceutical items in the above table. The proposed procurement action will be a firm-fixed-priced contract.

o Per DailyMeds product indications and usage:

INDICATIONS AND USAGE

1. As replacement or supplemental therapy in patients with hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis.

2. As pituitary TSH suppressants, in the treatment or prevention of various types of euthyroid goiters, including thyroid nodules, subacute or chronic lymphocytic thyroiditis (Hashimoto’s), multinodular goiter, and in the management of thyroid cancer.

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 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.

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 the pharmaceutical supply that has been specifically identified using the National Drug Code (NDC) and name.

A sources sought notice was not posted for this acquisition because pharmaceutical/med/surge buys are routine, and the Contracting Officer is very knowledgeable about the marketplace. It is unlikely that a source’s 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.

The station requested (3) pharmaceuticals; all are brand name specific. The first query was conducted within the VA image library, in order to get photos and confirm manufacturer(s). All three showed the manufacture as Forest Pharmaceutical. However, when an additional search was conducted on DailyMeds – the manufacturer was listed as Allergan. Upon supplementary research it was learned that Forest Pharmaceutical was purchased by Allegan in 2014. Therefore, the manufacture for the three brand name items is Allergan.

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.

o The national drug code(s) (NDC) 00456-0457-01 was used to query the website and resulted in Allergan as a manufacturer of THYROID 15MG (1/4 GRAIN) TAB 100CT. It is unclear where Allergan manufacture its product. The label only shows “distributed by” not “not manufactured in”.

o The national drug code(s) (NDC) 00456-0458-01 was used to query the website and resulted in Allergan as a manufacturer of THYROID 30-32.5MG (1/2 GRAIN) TAB 100CT It is unclear where Allergan manufacture its product. The label only shows “distributed by” not “not manufactured in”.

o The national drug code(s) (NDC) 00456-0461-01 was used to query the website and resulted in Allergan as a manufacturer of THYROID 120MG TAB 100CT (T0048). It is unclear where Allergan manufacture its product. The label only shows “distributed by” not “not manufactured in”.

Reviewed the National Acquisition Center (CCST) o Searched for GSA/FSS/PV Contracts using the three (3) NDCs that the station provided. NDC’s were searched via the Pharmaceutical Catalog Search –

This yielded no results.

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 131 SDVOSB/VOSBs who are registered as doing business under NAICs code:

325412. The manufacture of all three NDCs, Allergan was search individually and this yielded no results within the VetCert database.

Market research was conducted via Dynamic Small Business search which resulted in 27 small businesses who are registered as doing business under NACICs Code: 325412. The manufacture of all three NDCs, Allergan was search individually and this yielded no results within the VetCert database.

An “Entity” search was conducted on SAM.gov, searching the manufacturer Allergan.

Allergan is registered on SAM.gov where it confirmed they’re a large business within the Certs and Reps section.

In accordance with the Non-manufacturer rule as defined in 13 CFR 121.406(b), there are two or more SDVOSB/VOSB authorized distributors who can provide the three (3) requested pharmaceuticals. However, the contracting officer could not identify a small business manufacturer that could provide any of the three (3) pharmaceuticals as domestic end products to set this requirement aside for SDVOSB/VOSB. Furthermore, the non-manufacturer rule does not apply to specific set asides when under the simplified acquisition threshold (SAT). This acquisition is under the SAT and has been determined that a total small business set aside is appropriate for this acquisition. The CO has determined that the non-manufacturer rule is not applicable for this requirement and that there are small business authorized distributors who will compete for the award.

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 three requested pharmaceuticals, Allergan, has been determined to be large businesses.

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 Contract Specialist

J. Braden Smith Contracting Officer

JENNIFER

KNIGHT

Digitally signed by JENNIFER

KNIGHT

Date: 2023.08.23 14:28:03 -05'00'

JUSTIN SMITH Digitally signed by JUSTIN SMITH Date: 2023.08.24 06:58:53 -05'00'