S02_JandA_AP0091_Allsigned.pdf

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

DEPARTMENT OF VETERANS AFFAIRS

BRAND NAME/SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN

COMMERCIAL ITEMS IN ACCORDANCE WITH FAR 13.5

PHARMACEUTICAL

Acquisition Plan Action ID: 36C770-24-AP-0116

1. Contracting Activity: Department of Veterans Affairs, NCO 15 – CMOP Division - Contracting Office. 2237 – 760-24-1-050-0168, Leavenworth CMOP, Leavenworth, KS.

2. Nature and/or Description of the Action Being Processed: This procurement is for six (6) lines of brand name Thyroid medication/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 6.302-2. The proposed procurement action will be a new firm-fixed-price purchase order (PO).

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 six pharmaceuticals listed in the below table. Items are to be delivered 10 days after receipt of order.

One time delivery – needs immediately.

All six NDCs above are prescribed by VA physicians for the treatment of Thyroid related issues, such as hypothyroidism, goiters, and thyroid cancer management.

Labels from DailyMeds

Item Number IMFN CMOP

Description (All items are

BRAND NAME ONLY)

OEM

NAME NDC Quantity Unit of

Measure Packaging Multiple

0001 6201 VA CMOP Leavenworth - 760

T0048 THYROID

120MG TAB Allergan/AbbVie 00456-0461-01 288 BT 100

0002 6202 VA CMOP Leavenworth - 760

T0050 THYROID

180MG TAB Allergan/AbbVie 00456-0462-01 96 BT 100

0003 6203 VA CMOP Leavenworth - 760

T0053 THYROID

90MG TAB Allergan/AbbVie 00456-0460-01 720 BT 100

0004 6204 VA CMOP Leavenworth - 760

T0749 THYROID (ARMOUR)

60-65MG (1GRAIN) TAB Allergan/AbbVie 00456-0459-01 1008 BT 100

0005 6205 VA CMOP Leavenworth - 760

T0750 THYROID 15MG

(1/4 GRAIN) TAB Allergan/AbbVie 00456-0457-01 1008 BT 100

0006 6206 VA CMOP Leavenworth - 760

T0751 THYROID 30-32.5MG

(1/2 GRAIN) TAB Allergan/AbbVie 00456-0458-01 720 BT 100

Last Updated: 02/01/22 o o o

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(s) 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):

Last Updated: 02/01/22

Sole Source/ Brand Name

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.

6. 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.

7. 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 requirement.

8. 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 11/21/2023. Market research is being conducted on 12/8/2023 for the upcoming acquisition of six brand name thyroid pharmaceuticals.

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 six (6) 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 six (6) NDCs to confirm each manufacturer and product details. The manufacture for all items is Allergan/AbbVie.

Based on the product labels and past procurement data, it has been determined that all products are made in the USA and there for comply with BAA regulations set forth in FAR Part 25.

Last Updated: 02/01/22

The Contracting Officer conducted further searches in VetCert utilizing NAICS code: 325412 and yielded a total of 135 SDVOSB/VOSBs. Further market research was conducted via the SBA Dynamic Small Business Search database using the criteria of NAICS code: 325412, which resulted in 85 small businesses who identified as authorized distributors or manufacturers. Based on procurement history of other pharmaceuticals, it is anticipated that at least two or more of the small businesses are authorized distributors capable of fulfilling VA’s requirement at a fair and reasonable price.

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 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 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. 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. 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.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: Market research have shown Qualified businesses 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.

Last Updated: 02/01/22

Jennifer Norman Deputy Logistics Manager Charleston/Ladson CMOP

13. 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.

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

Michael McAlhaney Contracting Officer Network Contracting Office (NCO 15) – CMOP Division

JENNIFER KNIGHT

Digitally signed by JENNIFER

KNIGHT

Date: 2023.12.11 09:34:39 -06'00'

JENNIFER NORMAN

MICHAEL

MCALHANEY

Digitally signed by MICHAEL

MCALHANEY

Date: 2023.12.11 12:51:44 -06'00'