36C25919Q0294-002.pdf

VHAPM Part 806.3 Other Than Full and Open Competition (OFOC) SOP Attachment 2: Request for Sole Source Justification Format >SAT

OFOC SOP Revision 08 Page 1 of 4 Original Date: 03/22/11 Revision 08 Date: 04/18/2018

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Brand Name Justification (>SAT)

Acquisition Plan Action ID: 36C259-19-AP-2671

1. Contracting Activity: Department of Veterans Affairs, Veterans Health Administration (VHA)

Regional Procurement Office West, Network Contracting Office 19, 6162 South Willow Drive, Suite 300, Greenwood Village, CO 80111

Organizational Activity: Oklahoma City Veterans Affairs Health Care System (OKCVAHCS), 921 NE 13th Street, Oklahoma City, OK 73104

2237:

2. Nature and/or Description of the Action Being Processed: The action being reviewed and approved is a Brand Name Justification for Axumin. It is anticipated that a Firm-Fixed-Price Purchase Order with a base year and four one-year option periods will be awarded to the responsible offeror that is capable of providing the brand name supplies for the OKCVAHCS.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: Axumin injection is indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment.

4. Statutory Authority Permitting Other than Full and Open Competition:

( ) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements per FAR 6.302-1;

( ) (2) Unusual and Compelling Urgency per FAR 6.302-2;

( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per FAR 6.302-3;

( ) (4) International Agreement per FAR 6.302-4 ( ) (5) Authorized or Required by Statute FAR 6.302-5;

( ) (6) National Security per FAR 6.302-6;

( ) (7) Public Interest per FAR 6.302-7;

(X) FAR 13.5 Simplified Procedures for Certain Commercial Items: The authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. 1901 and is implemented by for restricting competition on this procurement via FAR 13.106-1(b)(2).

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Revision 08 Date: 04/18/2018

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): Axumin is an FDA approved, proprietary PET biomarker owned by Blue Earth Diagnostics Ltd. Blue earth Diagnostics Ltd. has entered into agreement with PETNET. PETNET is the exclusive manufacturer and distributor throughout the United States. Axumin is unique to one manufacturer since it is indicated for PET imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen levels following prior treatment. Axumin is currently the only FDA approved PET biomarker that is indicated for this particular PET imaging scan.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: A Request for Quote will be posted to www.fbo.gov in accordance with FAR

12.603 to ensure that offerors capable of meeting the brand name requirements will have an opportunity to provide a quote.

7. Description of the Market Research Conducted and the Results, or a Statement of the Reasons

Market Research Was Not Conducted: Market Research was conducted by searching the Vendor Information Pages (VIP) database and the Federal Procurement Data System (FPDS). A query of the VIP database produced 68 SDVOSB concerns under NAICS Code 325412. However, a query of FDPS indicates that this requirement is only available from one SDVOSB concern and one large business concern. Further Market Research was conducted by contacting the manufacturer of Axium. Axium is a proprietary PET biomarker owned by Blue Earth Diagnostics Ltd. Blue Earth Diagnostics Ltd. has entered into an agreement with PETNET. PETNET is the exclusive manufacturer and distributor of the drug throughout the United States. Axium may also be purchased through TrillaMed, PETNET’s authorized reseller for Federal Government requirements.

8. Any Other Facts Supporting the Use of Other than Full and Open Competition: There are no other facts supporting the use of other than full and open competition.

9. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: A Request for Quote will be posted to www.fbo.gov for this requirement. Market Research indicates that there are at least two sources capable of meeting this requirement.

10. 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: It is anticipated that competition will be received for this requirement.

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Revision 08 Date: 04/18/2018

11. 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.

30 APR 2019

07:23:38 -06'00'

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Revision 08 Date: 04/18/2018 c.