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FBO DAILY - FEDBIZOPPS ISSUE OF OCTOBER 31, 2018 FBO #6186
DOCUMENT

65 -- XOFIGO Ra-223 Injections 663-C95092 POP: 11/1/2018 - 10/31/2019 - Justification and Approval (J&A)

Notice Date

10/29/2018
 

Notice Type

Justification and Approval (J&A)
 

NAICS

325412 — Pharmaceutical Preparation Manufacturing
 

Contracting Office

Department of Veterans Affairs;Network Contracting Office 20;5115 NE 82nd Ave, Suite 102;Vancouver WA 98662
 

ZIP Code

98662
 

Archive Date

12/1/2018
 

Point of Contact

Michael Gamby
 

Small Business Set-Aside

N/A
 

Award Number

V797P-2202D 36C26019F0033
 

Award Date

11/1/2018
 

Description

VHAPM Part 808.405-6 Limiting Sources Attachment 2: Request for Limited Sources Justification Format >SAT VHAPM Part 808.405-6 Limiting Sources Original Date: 08/30/2017 Revision 01 Eff Date: 04/23/2018 Page of 4 LIMITED SOURCES JUSTIFICATION ORDER >SAT FAR PART 8.405-6 Acquisition Plan Action ID: VA260-18-AP-2298 Contracting Activity: Department of Veterans Affairs, VISN 20, Puget Sound Medical Center 2237: 663-19-1-062-0001 Description of Action: This acquisition is conducted under the authority of the Multiple- Award Schedule Program (41 U.S.C. 251 and 40 U.S.C. 501). This is a new requirement for a Base +3 Option Years for Reagents and Consumables for the Ortho Vision instrument and Workstation platforms at the Portland VAMC Laboratory. Order against: FSS Contract Number: V797P-2202D Name of Proposed Contractor: Bayer Healthcare Pharmaceuticals (c/o Cardinal Health) 100 Bayer Boulevard Whippany, NJ 07981 862-404-5922 Street Address: City, State, Zip: Phone: Description of Supplies or Services: The estimated value of the proposed action is $ 356,085.00 This request is to supply unit doses of Radium-223 Dichloride for the treatment of bone pain due to metastases from castrate-resistant prostate cancer. Each patient will receive the dose every four weeks for a total of six doses. The doses are based on patient weight and the amount to be requested will accommodate 5-6 patients in the one-year period of the contract, 11/1/2018 to 10/31/2019. Pricing unit is microcurie(uCi). Current pricing at the time of contract request is $79.19 per uCi. A total of 4500 uCi is requested for the period of performance of the contract. Total value of the contract is 4500 X $79.19 = $365,355. Individual doses are weight based. Dose schedule is 1.49uCi per kilogram. For example, a 100 kg patient will require 149 uCI (uinits). The ordering of each unit dose will be made by the Nuclear Medicine technologist to the XOFIGO Access hotline. The brand name of the radiopharmaceutical is XOFIGO. The generic name is Radium- 223 dichloride. It is a Bayer HealthCare Pharmaceuticals product. The product is solely distributed through Cardinal Healthcare. IDENTIFY THE AUTHORITY AND SUPPORTING RATIONALE (see 8.405-6(a)(1)(i)(A), (B), and (C) or 8.405-6(b)), AND IF APPLICABLE, A DEMONSTRATION OF THE PROPOSED CONTRACTOR S UNIQUE QUALIFICATIONS TO PROVIDE THE REQUIRED SUPPLY OR SERVICE. An urgent and compelling need exists, and following the ordering procedures would result in unacceptable delays. Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized; Currently, Bayer is the only vendor supplying Ra-223 dichloride, which is solely distributed through Cardinal Healthcare, under FSS V797P-2202D. In the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original order must not have been previously issued under sole source or limited source procedures. Items peculiar to one manufacturer: A patent, copyright or proprietary data limits competition. The proprietary data is: (If FAR 8.405-6(a)(2)iii before posting. Do not include specific proprietary data. Only mention the type of equipment, procedure, etc. to show that proprietary supplies or services are being procured.) These are direct replacements parts/components for existing equipment. The material/service must be compatible in all aspects (form, fit and function) with existing systems presently installed/performing. Describe the equipment/function you have now and how the new item/service must coordinate, connect, or interface with the existing system. DESCRIBE WHY YOU BELIEVE THE ORDER REPRESENTS THE BEST VALUE CONSISTENT WITH FAR 8.404(d) TO AID THE CONTRACTING OFFICER IN MAKING THIS BEST VALUE DETERMINATION: Currently, Bayer is the only vendor supplying Ra-223 dichloride, which is solely distributed through Cardinal Healthcare, under FSS V797P-2202D. In accordance with FAR 8.404(d) the prices delineated under schedule contract have already been determined fair and reasonable. DESCRIBE THE MARKET RESEARCH CONDUCTED AMONG SCHEDULE HOLDERS AND THE RESULTS OR A STATEMENT OF THE REASON MARKET RESEARCH WAS NOT CONDUCTED: Bayer is the only vendor supplying Ra-223 dichloride, which is solely distributed through Cardinal Healthcare, under FSS V797P-2202D. The Sole source documentation is located in the briefcase. ANY OTHER FACTS SUPPORTING THE JUSTIFICATION: This radioactive therapeutic pharmaceutical is used for palliation of bone pain caused by metastatic disease from castrate resistant prostate cancer. While there are other radioactive pharmaceutical agents that treats bone pain from metastases, it is the only product that has been shown to also extend life. The product name of the radiopharmaceutical is XOFIGO. The generic name is Radium-223 dichloride. It is a Bayer HealthCare Pharmaceuticals product and has market exclusivity for the drug. The product is solely distributed through Cardinal Healthcare. This use of this product is by the request of Oncology Service. While relatively expensive, Xofigo is used in lieu of chemotherapy, which has comparable cost. A STATEMENT OF THE ACTIONS, IF ANY, THE AGENCY MAY TAKE TO REMOVE OR OVERCOME ANY BARRIERS THAT LED TO THE RESTRICTED CONSIDERATION BEFORE ANY SUBSEQUENT ACQUISITION FOR THE SUPPLIES OR SERVICES IS MADE: N/A 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. I understand that processing of this limited sources justification restricts consideration of Federal Supply Schedule contractors to fewer than the number required by FAR Subpart 8.4. Randal S. Miura 463644 Digitally signed by Randal S. Miura 463644 Date: 2018.10.16 09:08:38 -07'00' SIGNATURE NAME: Randal Miura TITLE: Lead Technologist SERVICE LINE/SECTION: Nuclear Medicine FACILITY: Seattle VAMC APPROVALS IN ACCORDANCE WITH THE VHAPM Part 806.3 OFOC SOP: CONTRACTING OFFICER S CERTIFICATION (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief. Jodi R. Stevenson Digitally signed by Jodi R. 462949 Stevenson 462949 Date: 2018.10.19 13:19:20 -07'00' CONTRACTING OFFICER Jodi Stevenson - Contracting Officer NAME AND TITLE One Level Above the Contracting Officer (Required over the SAT but not exceeding $700K): I certify the justification meets requirements for other than full and open competition. Jonathan D. Jewel 198381 SIGNATURE Digitally signed by Jonathan D. Jewel 198381 Date: 2018.10.19 11:06:08 -07'00' Jonathan Jewel NCO 20, Supply 2 Branch Chief
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/notices/888c662cba241d6a9a0fb7d8b355551f)
 

Document(s)

Justification and Approval (J&A)
 

File Name: V797P-2202D 36C26019F0033 V797P-2202D 36C26019F0033_1.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=4658741&FileName=V797P-2202D-020.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=4658741&FileName=V797P-2202D-020.docx

 

Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
 

Record

SN05136908-W 20181031/181029230518-888c662cba241d6a9a0fb7d8b355551f (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
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