S02.JA Q0096.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

Effective Date: 02/01/2022 Page 1 of 4

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C770-24-AP-0136

1. Contracting Activity: Department of Veterans Affairs, Network Contracting Office 15, CMOP Division. 2237# 760-24-1-050-0223, Leavenworth CMOP

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. The proposed procurement action will be a new firm-fixed-price contract.

3. Description of Supplies/Services Required to Meet the Agency’s Needs:

Item Number IMF Description NDC Quantity

Unit of Measure

Packaging Multiple

0001 6201

THYROID 120MG TAB 100CT

(T0048)NAME BRAND ONLY 00456-0461-01 576 BT 100

0002 6202

THYROID 180MG TAB 100CT

(T0050) )NAME BRAND ONLY 00456-0462-01 96 BT 100

0003 6203

THYROID 90MG TAB 100CT (T0053)

)NAME BRAND ONLY 00456-0460-01 1008 BT 100

This will be a one time buy with delivery 10 days ARO.

Effective Date: 02/01/2022 Page 2 of 4

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. “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.

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

Effective Date: 02/01/2022 Page 3 of 4

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 12/12/2023. Market research is being conducted on 12/13/2023 for the upcoming acquisition of three 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 three (3) 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 three (3) NDCs to confirm each manufacturer and product details. The manufacture for all items is Allergan.

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.

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 56 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: n/a

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: n/a

Effective Date: 02/01/2022 Page 4 of 4

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.

Jennifer Norman Deputy Logistics Manager Leavenworth 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.

Kayla Powers Contract Specialist

NCO 15 CMOP

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.

Michael McAlhaney Contracting Officer

NCO 15 CMOP

JENNIFER NORMAN

KAYLA

POWERS

Digitally signed by

KAYLA POWERS

Date: 2023.12.15 09:44:59 -06'00'

MICHAEL

MCALHANEY

Digitally signed by

MICHAEL MCALHANEY

Date: 2023.12.15 10:49:29 -06'00'