P03 JA Over SAT EPS BC Signed_cp_p.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 3

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 22 AP 0959

Contracting Activity: Department of Veterans Affairs, NCO 15 Contracting, CMOP Division Hines CMOP, Nature and/or Description of the Action Being Processed:

The pharmaceutical requested in this requirement supplies the Hines CMOP Emergency Pharmacy Service (EPS). The EPS is under the VHA Directive 1047 (4/21/2020) establishing policy for national and local emergency pharmacy caches comprised of life saving pharmaceuticals and medical supplies for use in response to catastrophic public health emergencies. The Hines CMOP is required to maintain sufficient inventory at all times in case of these emergencies.

There are no alternate NDCs that can be used for this product. This is the only product in the market, and it does not have any generic equivalents. This was verified using the FDA Orange Book by Rachel Joseph, Facility Program Manager, EPS.

2237: 765 23 1 715 0001 Estimated Cost: $516,600.00

Description of Supplies Required to Meet the Agency’s needs:

Brand Specific

Atropine and Pralidoxime Chloride Injection (DUODOTE)

NDC: 11704 620 01

Items per Box: 30 Quantity: 246 Boxes With the longest expiration date as possible (2025 or beyond) With the least amount of lot numbers as possible Manufactured by Meridian medical Technologies LLC, St. Louis, MO, USA

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:

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

Effective Date: 02/01/2022 Page 2 of 3

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority):

The pharmaceutical Atropine and Pralidoxime Chloride Injection (DUODOTE) is only manufactured by Meridian Medical Technologies LLC (Meridian). Per the FDA Orange book, there are no alternates available.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable:

This will be posted on Contract Opportunities (sam.gov) as unrestricted so any vendor who can provide this item is welcome to quote.

The manufacturer, Meridian Medical Technologies LLC, was contacted for authorized distributors, resulting in two Small Businesses and four large businesses.

A Sources Sought was posted on SAM.gov from 10/6/22 to 10/13/22, resulting in two responses, one from a Small Disadvantaged Business, Regimed Medical and one from a Woman Owed Small Business, Purpose & Steadfast Solution. It is this survey of the marketplace, along with the listed authorized distributors, that confirms assumptions regarding the capability of industry to meet the needs of this requirement.

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 and/or the IGCE.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted:

Since the procurement is over SAT then the Non manufacture rule (NMR) applies. Due to the SBA NMR, as defined in FAR Part 19 and 13 Code of Federal Regulations (CFR) 121.406, an SDVOSB/VOSB/SB set aside of any kind is not feasible as there is no waiver of the Non Manufacturer Rule from SBA over the SAT or the associated NAICS code 325413. Based on this research and policy, the rule of two cannot be met to set the procurement aside for a socioeconomic subcategory of small business. This will be posted unrestricted.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: N/A

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition:

Sources Sought Notice identified the following interested vendors:

a. Regimed Medical, SDB

b. Purpose & Steadfast Solution, WOSB

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 3 of 3

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.

Justin Simon Date Inventory Management Specialist Hines 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.

Larry Zaritz Date Contracting Officer NCO15 – CMOP Division, Team 1

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.

Christy Pendlay Date Supervisory Contract Specialist NCO15 – CMOP Division, Team 1

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 $7.5 million (or $15.0 million for acquisitions described in FAR 13.500(c)) for other than full and open competition.

Name Date VHA Head of Contracting Activity (HCA)

Justin M Simon 422058

Digitally signed by Justin M Simon 422058 Date: 2022.10.25 08:34:28 -05'00'

LARRY ZARITZ

Digitally signed by LARRY

ZARITZ

Date: 2022.10.27 09:08:29 -05'00'

CHRISTY PENDLAY Digitally signed by CHRISTY PENDLAY Date: 2022.10.27 12:56:13 -05'00'