P03 - J_and_A Brand Name Under SAT_Redacted.pdf

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

Last Updated: 02/01/22 Page 1 of 2

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)

Thyroid Grain - Pharmaceutical – Leavenworth CMOP

Acquisition Plan Action ID: 36C770-22-AP-0749

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

2237 # 760-22-4-050-1200, Leavenworth CMOP.

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 pharmaceutical medication listed below in the following table. Thyroid Grain with thyroid hormone activity, alone or together with other therapeutic agents, have been used for the treatment of obesity. The estimated value of the required pharmaceutical medication is . Items are to be delivered 10 days after receipt of order.

Thyroid Grain 15MG (1/4 Grain) Tab 100CT:

NDC/Part#: 00456-0457-01 Quantity of request: 100 Per Bottle (BT) This is an individual brand name justification to support the procurement of Thyroid Grain

15MG (1/4 Grain) Tab 100CT. The Leavenworth CMOP Facility requires 1008 bottles to be procured with the support of the instant justification and approval for small business set-aside competition. The propose procurement action will be a firm fixed- price contract award for the supplies.

Thyroid Grain 30-32.5MG (1/2 Grain) Tab 100CT:

NDC/Part#: 00456-0458-01 Quantity of request: 100 Per Bottle (BT) This is an individual brand name justification to support the procurement of Thyroid Grain

30-32.5MG (1/2 Grain) Tab 100CT. The Leavenworth CMOP Facility requires 1008 bottles to be procured with the support of the instant justification and approval for small business set-aside competition. The propose procurement action will be a firm fixed- price contract award for the supplies.

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: Products have been prescribed for veteran patients by VA Physicians. VA Pharmacy employees do not have the training and/or authority to countermand VA physician orders. “Brand Specific” products are the same thing as “dispense as written” on a VA 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

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

Last Updated: 02/01/22 Page 2 of 2 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: As described in Section 3 above, market research, in accordance with FAR Part 10, I will be posting a synopsis of the proposed acquisition, advising industry of the pending acquisition and soliciting inquiries from interested parties; however, non-manufacturer requirements apply and the VIP database search concluded there are no known SDVOSB or VOSB manufacturers of the above referenced pharmaceutical medication for NAICS code 325412. Therefore, the “Rule of Two” cannot be met and a SDVOSB set-aside is not feasible. Although, the Nonmanufacturer Rule (NMR) applies, due to the time constraints of this acquisition, there is not sufficient time to request an individual waiver the NMR.

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.

Note: COs are required to make a determination of price reasonableness IAW FAR 13.106-3. See the S19 Open Market (FAR13) Award Documentation Form with Abstract to document price reasonableness.

James Hogue Date Contracting Officer National CMOP Contracting Office (NCO 15)

JAMES

HOGUE

Digitally signed by

JAMES HOGUE

Date: 2022.07.21 10:02:58 -05'00'