JA - Axumin - HCA Signed - Copy_Redacted.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 09 Page 1 of 5 Original Date: 03/22/11 Revision 09 Date: 04/17/2020

DEPARTMENT OF VETERANS AFFAIRS 316-685-2221 x54575

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C255-20-AP-2534

1. Contracting Activity:

Network Contracting Office (NCO) 15, 3450 S 4th Street Trafficway, Leavenworth, KS. 66048

Department of Veterans Affairs, Robert J. Dole VA Medical Center, 5500 E. Kellogg Avenue Wichita, KS. 67218-1607

2. Nature and/or Description of the Action Being Processed:

Brand Name requirement to acquire Axumin (fluciclovine F 18) through an IDIQ Contract with Base Year and Four (4) One Year Options. Base year anticipated start date is September 1, 2020.

This procurement is 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.

This will be a single award IDIQ Contract

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

Axumin (fluciclovine F 18) is a novel molecular imaging agent indicated for use in positron emission tomography (PET) imaging to identify suspected sites of prostate cancer recurrence in men who have elevated blood levels of prostate specific antigen (PSA) following prior treatment.

Period of Performance: Anticipated Base Year start date is September 1, 2020.

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

( X ) (1) 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 due to the brand-name requirement peculiar to

OFOC SOP Revision 09 Page 2 of 5 Original Date: 03/22/11 Revision 09 Date: 04/17/2020 one manufacturer (only one responsible source and no other supplies will satisfy Agency requirements).

( ) (2) Unusual and Compelling Urgency per 41 USC §3304(a)(2) as implemented by FAR 6.302-2;

( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per 41 USC §3304(a)(3) as implemented by FAR 6.302-3;

( ) (4) International Agreement per 41 USC §3304(a)(4) as implemented by FAR 6.302-4 ( ) (5) Authorized or Required by Statute per 41 USC §3304(a)(5) as implemented by FAR 6.302-5;

( ) (6) National Security per 41 USC §3304(a)(6) as implemented by FAR 6.302-6;

( ) (7) Public Interest per 41 USC §3304(a)(7) as implemented by FAR 6.302-7;

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 available through , manufacturer and exclusive commercial distributor in the United States. is an authorized distributor of this product, which is supported by an Authorized Distributor Letter issued by , a large business manufacturer.

The Radiologists determined that the radiopharmaceutical being requested is the most appropriate to serve the specific needs of the patients. Substituting with other brands other than that specially prescribed is beyond the role, competency, and professional functions of the Contracting Officer.

Due to the unique radioactive components, the radiopharmaceutical product begin to decay immediately. There are storage requirements for these products. For these reasons, a stock cannot be maintained. The product must be delivered on as needed basis, completely dependent on workload.

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

This requirement will be solicited on the Open Market as Unrestricted.

Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable:

The Contracting Officer will determine the price to be fair and reasonable prior to award in accordance with FAR 13.106-3(a).

Pric will be determine , pricing on similar contract, the IGCE.

OFOC SOP Revision 09 Page 3 of 5 Original Date: 03/22/11 Revision 09 Date: 04/17/2020

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

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

Communication with shows Axumin as the only FDA Approved product featuring fluciclovene F18.

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

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:

Axumin is not offered as a generic drug at this time. It is used to diagnose recurrent disease in patients previously treated with prostate cancer who now develop increased PSA consistent with recurrence. There is no other modality as effective.

This requirement will be solicited on the Open Market as Unrestricted.

OFOC SOP Revision 09 Page of Original Date: 03/22/11 Revision 09 Date: 04/17/2020

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.

(This signature is the requestor’s supervisor, fund control point official, chief of service, someone with responsibility and accountability)

Name Date Title Facility

13. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP: This part if filled out by Contracting Staff as part of the Justification

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.

Date

b. I certify the justification meets requirements for other than full and open competition.

Date

Name

c. I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and recommend approval for other than full and open competition.

Date

VALERIE S

MOLINA 104056

Digitally signed by VALERIE

S MOLINA 104056

Date: 2020.07.20 16:38:08 -05'00'

Emilio Ballentos 632259

Digitally signed by Emilio Ballentos 632259 Date: 2020.07.29 11:15:00 -05'00'

Jessica A. Edwards 368963 Digitally signed by Jessica A. Edwards 368963 Date: 2020.07.30 10:14:46 -05'00'

Name Title Facility

SCOTT R FISCUS 381888 Digitally signed by SCOTT R FISCUS 381888 Date: 2020.08.06 14:31:30 -05'00'

OFOC SOP Revision 09 Page of Original Date: 03/22/11 Revision 09 Date: 04/17/2020

I have reviewed the accurate to the best of my knowledge and belief and ther than full and open competition.

Date

_____________________________ 08/07/2020

TERRY L.

SPITZMILLER

394683

Digitally signed by TERRY

L. SPITZMILLER 394683

Date: 2020.08.07 12:58:46 -05'00'