Attachment 1 FAR 13.5 Brand Name Justification - 36C77022Q0335_Redacted.pdf

Last Updated: 02/01/22

DEPARTMENT OF VETERANS AFFAIRS

BRAND NAME JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C770-22-AP-0557

1. Contracting Activity: Department of Veterans Affairs, VISN 15, Leavenworth CMOP using 2237

#760-22-3-050-0869 by the Leavenworth CMOP Contracting Office, Leavenworth, KS.

2. Nature and/or Description of the Action Being Processed: This procurement is for pharmaceuticals in accordance with FAR 13.5 Simplified Procedures for certain commercial items and specifically FAR

13.501 Special Documentation Requirements, where acquisitions conducted under simplified acquisition procedures are exempt from the requirements of FAR Part 6, but still require a justification using the format of FAR 6.303-2.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: This is an individual brand name justification to support the procurement of the ERRIN 0.35MG TAB (NDC: 51862-0886-03) which is a pharmaceutical item listed below. The estimated value of the required pharmaceutical supply is . Items are to be delivered 10 days after receipt of order.

ERRIN 0.35MG Tab:

• NDC/Part# - 51862-0886-03

• Quantity of request: 192 Boxes (BX)

4. Statutory Authority Permitting Restricted Competition:

FAR 13.5 Simplified Procedures for Certain Commercial Items. The statutory authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. § 1901 and is implemented by FAR 13.106-1(b)(2) for restricting competition on this procurement. Competition is restricted on this procurement for the reason below:

( X ) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements

( ) Unusual and Compelling Urgency ( ) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert

Services ( ) International Agreement ( ) Authorized or Required by Statute ( ) National Security ( ) Public Interest

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): Products have been prescribed for patients by VA Physicians. Pharmacy employees do not have the training and/or authority to countermand physician orders. “Name Brand Only/Gray Market Requirements” products are the samething as “dispense as written” on a physician prescription. Absolutely no Generic Errin 0.35mg Tab quotes will be accepted – Name Brand Only. 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 (DNF) will most always identify “Name Brand Only/Gray Market Requirements” products in the VA PRINT NAME. Vendors must provide proof of supply from an authorized MFG distributor. 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.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: A synopsis of this requirement and the RFQ will be posted to SAM.gov as a Brand Name procurement for line item 14. Line item 1 – 13 are not brand specific items. Only qualified vendors will be able to submit quotes due to Gray Market/Name Brand only requirements for line item 14.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: The anticipated cost will be fair and reasonable based off competition or the IGCE.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons

Market Research Was Not Conducted: As described in Section 6 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 MedSurg item 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.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: This will be an other than full and open RFQ due to Gray Market / Brand Name only requirements.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: Qualified business vendors tend to vary from procurement to procurement.

11. A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to

Competition before Making subsequent acquisitions for the supplies or services required: No action is being taken at this time due to the fact that no NDC substitutions are permitted based on physician’s specific orders.

12. Requirements Certification: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

Wise, Julie Date Inventory Management Specialist Leavenworth CMOP

13. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

Julie G. Wise 406323

Digitally signed by Julie G. Wise 406323 Date: 2022.05.16 15:04:24 -05'00'

a. Contracting Officer or Designee’s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Prepared and Approved by:

Hogue, James Date Contracting Officer Leavenworth CMOP

JAMES

HOGUE

Digitally signed by

JAMES HOGUE

Date: 2022.05.16 15:31:46 -05'00'