S02_JnA_Q0393_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-0843

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

2237 # 760-23-4-050-1279, Leavenworth CMOP, Leavenworth, KS

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

Item Number

ITEM MASTER

FILE NUMBER CMOP Description

NATIONAL

STOCK

NUMBER Quantity Unit of

Measure Packaging Multiple

0001 17307 VA CMOP Leavenworth - 760 ERRIN 0.35MG TAB,28 (E0586) BRAND NAME 51862-0886-03 144 BX 3

0002 5119 VA CMOP Leavenworth - 760 FENOFIBRATE 200MG CAP, 100'S, F0227 27241-0120-04 144 BT 100

0003 5120 VA CMOP Leavenworth - 760 FENOFIBRATE 134MG CAP, 100'S, F0238 27241-0119-04 288 BT 100

0004 10997 VA CMOP Leavenworth - 760 FLUNISOLIDE 0.025% 200D NASAL INH SPRAY 25ML (F0404) 24208-0344-25 360 BT 1

0005 19394 VA CMOP Leavenworth - 760 FESOTERODINE FUMARATE 4MG SA TAB 30 COUNT (F0423) 67877-0064-30 864 BT 30

0006 2952 VA CMOP Leavenworth - 760 GALANTAMINE HYDROBROMIDE 8MG SA CAP 30CT, G0257 65862-0744-30 384 BT 30

0007 13110 VA CMOP Leavenworth - 760 HCTZ 12.5/OLMESARTAN 40MG TAB 90CT, H0428 13668-0252-90 288 BT 90

0008 19585 VA CMOP Leavenworth - 760 ISOSORBIDE MONONITRATE 20MG ORAL TAB 100CT (I0084) 00228-2620-11 96 BT 100

0009 19872 VA CMOP Leavenworth - 760 LITHIUM CARBONATE 300MG TAB 1000CT (L0048) 0054-4527-25 24 BT 1000

0010 4921 VA CMOP Leavenworth - 760 LIDOCAINE 2.5/PRILOCAINE 2.5% CREAM 30GM TUBE (L0091) 00574-2042-30 1200 TU 30

This is an individual brand name justification to support the procurement of the one (1) Brand Name Specific pharmaceutical item (ERRIN 0.35MG TAB,28 (E0586) in the above table (line item:1 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:

INDICATIONS AND USAGE

Indications

Progestin-only oral contraceptives are indicated for the prevention of pregnancy.

2. Efficacy If used perfectly, the first-year failure rate for progestin-only oral contraceptives is 0.3%. However, the typical failure rate is estimated to be closer to 9%, due to late or omitted pills. Table 1 lists the pregnancy rates for users of all major methods of contraception.

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.

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.

o The station provided the sole, brand name NDC for ERRIN 0.35MG TAB,28 (E0586). (51862-0886-03) The first query was conducted within the VA image library, in order to get photos and confirm manufacturer name.

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: 51862-0886-03) was used to query the website and resulted in Mayne Pharma Inc. as a manufacturer of ERRIN 0.35MG TAB,28. The manufacturer Mayne Pharma manufactures its product non-domestically in the UK. Progestin-only oral contraceptives are indicated for the prevention of pregnancy.

o Reviewed the National Acquisition Center (CCST) Searched for GSA/FSS/PV Contracts using the station approved/ requested Brand Name NDC’s (51862-0886-03) NDC was searched via the Pharmaceutical Catalog Search – This search 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 (130) SDVOSB/VOSBs who are registered as doing business under NAICs code:

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

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

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

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

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 ten (10) requested pharmaceuticals. However, the contracting officer could not identify a small business manufacturer that could provide any of the ten (10) 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 requested pharmaceutical(s) has been determined to be a Large Business.

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: 2023.08.16 11:35:45 -05'00'

JUSTIN SMITH Digitally signed by JUSTIN SMITH Date: 2023.08.16 14:20:20 -05'00'