S02_JnA_Q0079_allsigned.pdf

36C77025Q0079 | 5-line Pharmaceutical

Last Updated: 02/01/22

VHAPG Part 813.5 Simplified Acquisition Procedures for Certain Commercial Items Attachment 1: Request for Sole Source Justification Template >SAT $7.5M under FAR13.5

DEPARTMENT OF VETERANS AFFAIRS

BRAND NAME JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR

CERTAIN COMMERCIAL ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C770-25-AP-0124

Contracting Activity: The Department of Veterans Affairs, NCO 15 – CMOP Division - Contracting Office will be procuring this acquisition for five (5) brand specific pharmaceuticals. Contracting office will utilize 2237: 760-25-1-050-0154 – for the replenishment of low stock levels at the Leavenworth CMOP.

Nature and/or Description of the Action Being Processed: This procurement is for five line items – brand name pharmaceuticals ee chart below n 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. The proposed procurement action will be a new firm-fixed-price contract.

Description of Supplies/Services Required to Meet the Agency’s Needs: This is an individual brand name justification to support the procurement of five (5) brand name pharmaceuticals listed in the below table. Delivery Schedule will be 10 days ARO.

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

ITEM

NUMBER

ITEM

MASTER FILE

NUMBER ADDRESS2 DESCRIPTION NDCs QTY

UNIT OF

MEASURE

PACKAGING

MULTIPLE

OEM

NAME

0001 6202 VA CMOP Leavenworth 760 ARMOUR THYROID 180MG TAB 100CT 00456 0462 01 192 BT 100 Abbvie 0002 6201 VA CMOP Leavenworth 760 ARMOUR THYROID 120MG TAB 100CT 00456 0461 01 720 BT 100 Abbvie 0003 6203 VA CMOP Leavenworth 760 ARMOUR THYROID 90MG TAB 100CT 00456 0460 01 1008 BT 100 Abbvie 0004 6204 VA CMOP Leavenworth 760 ARMOUR THYROID 60 65MG (1 GRAIN) TAB 100CT 00456 0459 01 1728 BT 100 Abbvie 0005 6206 VA CMOP Leavenworth 760 ARMOUR THYROID 30 32.5MG (1/2 GRAIN) TAB 100CT 00456 0458 01 1728 BT 100 Abbvie

VHAPG Part 813.5 Simplified Acquisition Procedures for Certain Commercial Items Attachment 1: Request for Sole Source Justification Template >SAT $7.5M under FAR13.5

Last Updated: 02/01/22

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’s 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 mist 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 Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: A synopsis of this requirement will be posted to SAM.gov and the RFQ will be posted as Other than Full and Open Competition. Only qualified vendors will be able to submit quotes due Drug Supply Chain Security Act (DSCSA) requirements. Vendors must hold an unexpired wholesale state distributor license.

Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: Contracting Officer anticipates cost of award will be fair and reasonable based on competition, the Independent Cost Government Estimate (IGCE), and previous acquisition cost history for the same requirements.

Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: In accordance with FAR Part 10 and VAAR 810 market research was conducted. The procurement package was received by the Contracting Office on 11/05/2024 Market research is being conducted on 11/26/2024 for the upcoming acquisition for Various- Armour Thyroid.

A sources sought notice was not posted for this acquisition because pharmaceutical buys are routine, and the Contracting Officer is very knowledgeable about the pharmaceutical 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.

All five (5) line-items are brand name only. A search was conducted on the National Institute of Health (NIH) U.S. National Library of Medicine DailyMeds using all five (5) NDCs to confirm each manufacturer & product details.

Once the OEMs were confirmed, searches continue in VetCert database. First using the NAICS Code: 325413 and then more specifically, searching all the manufacturer/ OEMs.

Attachment 1: Request for Sole Source Justification Template >SAT $7.5M under FAR13.5

Last Updated: 02/01/22

VetCert, https://veterans.certify.sba.gov/#home - generated 133 SD/VOSB businesses using NAICS code: 325412

The database was checked for the OEM, Abbvie - and yielded no results. Confirming that the OEMs not registered with VetCert.

The businesses that did generate are distributors of large wholesalers.

b. The following databases/websites were queried to identify manufacturers/packagers and domestic availability of the required pharmaceuticals.

SAM.gov – o OEM was searched on https://sam.gov/content/home o OEM - Abbvie is registered and all confirmed to be a large businesses.

Federal Procurement Data System (FPDS) https://www.fpds.gov/fpdsng_cms/index o Past procurements were reviewed – Looked for last listed country of origin information as reported.

SBA – DSBS

o https://dsbs.sba.gov/search/dsp_dsbs.cfm o 32 Vendors generated as doing business with NACIS Code:

325412, with Keyword: Manufacturing.

o The Vendor Specific OEM, Abbvie was searched and did not generate on the SBA/DSBS website. Confirming that the OEM is not registered with SBA.

NAC – National Acquisition Center (CCST) o https://www.vendorportal.ecms.va.gov/NAC/Search o Searched all five (5) requested NDCs on the pharmaceutical

Catalog.

This yielded no results.

c. The Nonmanufacturer Rule The Contracting Officer reviewed the Non-Manufacturer Rule.

In accordance with the Non-Manufacturer Rule as defined in 13 CFR 121.406(b), there are two or more small business concerns who identify themselves as authorized distributors.

These small businesses have 500 or less employees, engage in

Attachment 1: Request for Sole Source Justification Template >SAT $7.5M under FAR13.5

Last Updated: 02/01/22 the retail wholesale trade and normally sell pharmaceuticals, take ownership or possession of the pharmaceutical via its facilities or via its personnel. However, market research concludes that there are presently no small business manufacturers that exist in the commercial marketplace. The CO has confirmed there is no class waiver associated for Medical Surgical Supplies under NAICS Code 325413. The Contracting Officer considered the use of an individual waiver, however, is not feasible due to the expedient nature of this acquisition. A small business set-aside is not feasible as a small business would not be able to comply with the NMR since there are presently no small business manufacturers.

9. Discuss consideration to BAATAA/Exception to BAA (See FAR Part 25) These items are Brand Name/ Dispense as written only. Per FAR 25.01(a)(5) the use of the sole source justification for brand name only - is an exception to the use of trade agreements.

Therefore, BAA applies. However, market research and past procurement history indicates all items are made in the USA. Therefore, comply with BAA regulations.

10. Any Other Facts Supporting the Use of Other than Full and Open Competition:

Previous acquisition history with this VA contracting office has shown a mix of large and small businesses have met and fulfilled this product in the recent past.

11. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: Market research shows previous acquisition history with this VA contracting office has shown a mix of large and small businesses have met and fulfilled this product in the recent past.

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:

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.

Attachment 1: Request for Sole Source Justification Template >SAT $7.5M under FAR13.5

Last Updated: 02/01/22

Signature:

Jennifer Knight Contract Specialist Network Contracting Office (NCO 15) – CMOP Division

Signature:

Tristian Ferguson Inventory Management Specialist Leavenworth CMOP

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

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.

Signature:

Kelley Cunningham Contracting Officer Network Contracting Office 15 – CMOP Division

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $750K): I certify the justification meets requirements for other than full and open competition.

Signature:

J. Braden Smith Branch/Division Chief Network Contracting Office 15 – CMOP Division

Jennifer Knight Digitally signed by Jennifer Knight Date: 2024.11.27 14:19:29 -06'00'

TRISTAN

FERGUSON

Digitally signed by TRISTAN

FERGUSON

Date: 2024.12.02 08:15:11 -06'00'

KELLEY

CUNNINGHAM

Digitally signed by KELLEY

CUNNINGHAM

Date: 2024.12.02 11:29:56 -06'00'

JUSTIN SMITH Digitally signed by JUSTIN SMITH Date: 2024.12.03 06:47:27 -06'00'

Attachment 1: Request for Sole Source Justification Template >SAT $7.5M under FAR13.5

Last Updated: 02/01/22

Signature:

Andrew J. Raiber Director of Contracting Network Contracting Office 15

c. VHA RPO HCA Review and Approval: I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and approve ($750K to $7.5million (or $15.0 million for acquisitions described in FAR 13.500(c)) for other than full and open competition.

Signature:

Daryl A. Berg Executive Director, RPO Central Head of Contracting Activity

ANDREW

RAIBER

Digitally signed by ANDREW

RAIBER

Date: 2024.12.03 14:59:13 -06'00'

DARYL BERG

Digitally signed by DARYL BERG Date: 2024.12.06 10:08:49 -06'00'