P03 - RPO signed SSJ_Redacted.pdf

PM Part 813.5 SAP for Certain Commercial Items Page 1 of 3 Original Date: 08/30/17 Revision 02 Date: 08/04/2020

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C25220AP4391

1. Contracting Activity: Department of Veterans Affairs, VISN 12, Hines VA Medical Center, along with

Network Contracting Office (NCO) 12, and Great Lakes Acquisition Center (GLAC) 2237: 578-21-1-735-0002

2. Nature and/or Description of the Action Being Processed: A new firm-fixed (5) five year IDIQ contract with PETNET Solutions for PET Prostrate Radiopharmaceuticals, Fluciclovine F-18 Axumin.

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

The total estimated value of the proposed action is $1,092,688.00

This procurement is for the Radiopharmaceutical Drug, Axumin Fluciclovine F-18. Imaging Service, Nuclear Medicine Section at Hines VA Hospital requires the provision of unit dose PET Rediopharmaceutical for diagnostic patient care. PET Pharmaceuticals have a short shelf life (<6 hours), necessitating the requirement for local production and delivery.

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): Blue Earth Diagnostics Ltd of Oxford, UK is the manufacturer of Axumin. Axumin F18 Fluciclovine is a proprietary agent that is not generically available at this time. Axumin was approved by the FDA on May 27, 2016 and is the first FDA approved F-18 PET imaging agent indicated for use in patients with suspected recurrent

PM Part 813.5 SAP for Certain Commercial Items Page 2 of 3

Revision 02 Date: 08/04/2020 prostate cancer. Blue Earth Diagnostics and PETNET solutions have a commercially exclusive agreement to provide Axumin in the United States. As of 2016 commercial production is underway at certain Siemens’ PETNET solutions radiopharmacies.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: At this time there is only one source in the US that can provide Axumin.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: This radiopharmaceutical is covered under a patent which expires on December 30, 2035. There is currently no therapeutically equivalent version of Axumin available in the United States. On our current contract

According to a commercial website the nationwide average cost per dosage is $11,310.00. I have determined the price we anticipate paying to be fair and reasonable.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Based on the market research conducted, no two or more VIP verified and capable SDVOSBs or VOSBs were identified and appeared capable of performing the requirement. In addition, no small business in any of the other targeted socio-economic groups appeared to qualify for a set-aside or sole source procurement. Therefore, it is anticipated that the CO will move forward with a Sole Source based on the information provided above. This market research information is not more than 12 months old.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: None.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: None.

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: The facility will re-evaluate if an alternative agent becomes available.

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.

Nicholas Friedman MD Date Section Chief Nuclear Medicine Hines VAMC

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.

______________ 10/25/2020

PM Part 813.5 SAP for Certain Commercial Items Page 3 of 3

Revision 02 Date: 08/04/2020

Teresa Beers-Wesolowski Date Contracting Officer

GLAC

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $700K): I certify the justification meets requirements for other than full and open competition.

David Picchi Date NCO 12, Branch Chief Supply

GLAC

c. Director of Contrating Review: I certify the justification meets requirements for other than full and open competition.

Paul Lauro Date Director of Contracting

GLAC/NCO 12

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 ($700K to $7 million (or $13.0 million for acquisitions described in FAR 13.500(c)) for other than full and open competition.

Terry L. Spitzmiller Executive Director Date Regional Procurement Office Central (VHA)

25 Nov 2020

Teresa J. Beers-

WESOLOWSKI 324002

Digitally signed by Teresa J.

Beers-WESOLOWSKI 324002 Date: 2020.11.25 12:16:56 -06'00'

David J Picchi 1428405 Digitally signed by David J Picchi 1428405 Date: 2020.11.25 12:35:47 -06'00'

Paul M. Lauro 1463508

Digitally signed by Paul M.

Lauro 1463508 Date: 2020.11.25 16:03:18 -06'00'

12/03/2020

TERRY L.

SPITZMILLER

394683

Digitally signed by TERRY

L. SPITZMILLER 394683

Date: 2020.12.03 12:07:11 -06'00'