S02_JnA_Q0429.pdf

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

Last Updated: 02/01/22 Page 1 of 3

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: 36C770-23-AP-0787

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

0001 5566 SALSALATE 750MG

TAB, 1000CT (S0004)

10135-0493-

48 BT 1000

0002 18664 SULFAMETHOXAZOLE

400/TRIMETH 80MG

TAB 500CT (S0051)

57237-0232-

48 BT 500

0003 2935 TORSEMIDE 10MG

TAB 100CT (T0235)

31722-0530-

2880 BT 100

0004 16575 TEMOZOLOMIDE

5MG CAP 5CT, T0473

16729-0048-

30 BT 5

0005 16593 TEMOZOLOMIDE

20MG CAP 5CT

(T0474)

16729-0049-

60 BT 5

0006 16594 TEMOZOLOMIDE

20MG CAP 14CT

(T0474)

16729-0049-

24 BT 14

0007 16596 TEMOZOLOMIDE

180MG CAP 5CT,

T0642

16729-0130-

90 BT 5

0008 6205 THYROID 15MG (1/4

GRAIN) TAB 100CT

(T0750)

00456-0457- 01 – Name Brand Only

1008 BT 100

0009 6206 THYROID 30-32.5MG

(1/2 GRAIN) TAB

100CT (T0751

00456-0458- 01 – Name Brand Only

1008 BT 100

0010 14770 VERAPAMIL HCL

120MG SA TAB

100CT (V0054)

68462-0292-

960 BT 100

This is an individual brand name justification to support the procurement of two (2) pharmaceuticals listed in the table above. The proposed procurement action will be a firm-fixed-price contract award for the supplies. Line item 0008 and 0009, Thyroid medication, are the only two name brand items within the requirement.

Last Updated: 02/01/22 Page 2 of 3

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.

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 June 21, 2023, and then sent to contract specialist desktop; however, CS was unable to complete. Procurement packet was then sent to another contracting officer’s desktop on September 7, 2023. Market research was conducted on September 8, 2023, 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 this these thyroid products 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 thyroid medications. 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 and yielded a total of 132 SD/VOSBs who identified as authorized distributors. Further market research was conducted via Dynamic Small Business search (DSBS) which resulted in 57 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

Last Updated: 02/01/22 Page 3 of 3 available (both large and small business concerns) in the marketplace. Allergan, Inc., the manufacturer of the thyroid medication is a large business concern. The product is manufactured domestically in the USA.

The Contracting Officer reviewed the Non-Manufacturer Rule (NMR). In accordance with the NMR as defined in 13 CFR 121.406(b), there are two or more SD/VOSB authorized distributors who can provide the pharmaceuticals. However, the contracting officer could not identify a small business manufacturer that can provide the product as a domestic end product to set this requirement aside for SD/VOSB concerns. Furthermore, the NMR 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 NMR is not applicable for this requirement and that there are small business authorized distributors who will compete for the award.

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