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FBO DAILY - FEDBIZOPPS ISSUE OF JUNE 29, 2017 FBO #5697
DOCUMENT

65 -- Therasphere-therapeutic glass microspheres - Attachment

Notice Date

6/27/2017
 

Notice Type

Attachment
 

NAICS

325412 — Pharmaceutical Preparation Manufacturing
 

Contracting Office

Department of Veterans Affairs;Columbus;Chalmers P. Wylie Ambulatory Care Center;420 North James Road;Columbus OH 43219-1834
 

ZIP Code

43219-1834
 

Solicitation Number

VA25017N0753
 

Archive Date

8/26/2017
 

Point of Contact

Gina P. Crank
 

E-Mail Address

Contracting Officer
(gina.crank@va.gov)
 

Small Business Set-Aside

N/A
 

Description

Page 1 of 3 VA250-17-N-0753 - NOTICE OF INTENT TO SOLE SOURCE -TheraSphere, Y-90 Glass Microsphere The Department of Veterans Affairs, The Louis Stokes Cleveland Department of Veteran Affairs Medical Center, 10701 East Boulevard, Cleveland, Ohio 44106 intends to solicit and negotiate with only one source under the authority of FAR 6.302-1(a)(2), Only one responsible source and no other supplies or services will satisfy agency requirements. The VA intends to solicit and negotiate with Biocompatibles Inc., 115 Hurley Road, Building 3, Oxford, Connecticut 06478 for TheraSphere, Y-90 Glass Microsphere Therapeutic doses. TheraSphere is a therapeutic agent used to treat unresectable primary Hepatocellular Carcinoma. It consists of microscopic glass spheres that are attached to a radioactive isotope (Y-90) and then injected into the patient. The spheres are trapped in the liver where they can treat liver cancer. The Government believes that only one business can satisfy the agency requirements and intends to negotiate with only one source under the authority of FAR 6.302-1(a)(2), Only one responsible source and no other supplies or services will satisfy agency requirements. Other persons may identify their interest and capability to respond to this requirement by Friday, June 30, 2017 at 4PM EST. Such capabilities information will be used solely for the purpose of determining whether or not to conduct this procurement on a competitive basis.  All information shall be furnished at no cost or obligation to the Government.   A determination by the Government not to open the requirement to competition based upon responses to this notice is solely within the discretion of the Government. No solicitation is available now.   All inquiries must be submitted by email to Gina P. Crank at gina.crank@va.gov Enter RFQ VA250-17-N-0753 TheraSphere, Y-90 glass microsphere in the email subject line. Please see the below Justification for the complete description of the requirement. DEPARTMENT OF VETERANS AFFAIRS Justification and Approval (J&A) For Other Than Full and Open Competition (>$150K) Acquisition Plan Action ID: VA250-17-AP-8383 Contracting Activity: Department of Veterans Affairs, VISN/NCO 10, VA Ambulatory Care Center Columbus, OH will be responsible for this proposed contracting action by using 2237# 541-17-3-778-0191 for the Louis Stokes Cleveland VA Medical Center. Nature and/or Description of the Action Being Processed: This is to purchase, on a Sole Source basis, TheraSphere ®, Y-90 Glass Microsphere doses. TheraSphere ® is a therapeutic agent used to treat unresectable primary Hepatocellular Carcinoma. This will be awarded as a Firm Fixed Price, new Contract. Description of Supplies/Services Required to Meet the Agency s Needs: TheraSphere ®, Y-90 Glass Microsphere doses are for therapy of Hepatocellular Carcinoma. It consists of microscopic glass spheres that are attached to a radioactive isotope (Y-90) and then injected into the patient. The spheres are trapped in the liver where they can treat liver cancer. These doses are distributed by BTG/Biocompatibles, Inc. The request is to purchase twelve (12) doses for a period of one (1) year. The estimated initial delivery date is July 1, 2017. All other doses will be delivered on an as needed basis. Statutory Authority Permitting Other than Full and Open Competition ( x ) (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; Demonstration that the Contractor s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): TheraSphere ®, Y-90 glass microsphere doses are proprietary, patented and are only available from one distributor, BTG /Biocompatibles Inc., the sole distributor of TheraSphere ® within the United States. The Biocompatibles Division holds the exclusive licenses for the distribution of TheraSphere ®, Y-90 glass microsphere doses. Accordingly, BTG/Biocompatibles Inc. is the only firm capable of providing the supplies and services described in Section 3 above without the Veteran s Health Administration experiencing unacceptable delays in fulfilling its requirements. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: BTG/Biocompatibles Inc. was contacted, they provided correspondence stating they are both the sole manufacturer and the sole distributor of TheraSphere ® within the United States. Determination by the Contracting Officer that the Anticipated Cost to the Government will be Fair and Reasonable: The anticipated cost to the Government is in line with the IGCE and previous acquisitions. 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 the Contracting Officer and Nuclear Medicine to identify available sources to meet the requirements. An internet search for Therasphere distribution was completed. The top ten results were six (6) sites that were information about TheraSphere, two (2) sites noted issues with the administration sets, one (1) site was about the clinical trials of TheraSphere and one (1) site discussed the distribution of Therasphere and that BTG is the distributor. Also, a search of the National Acquisition Center s Pharmaceutical Catalog was conducted, no records were found. Based on the results of the market research, the government determined that there is only one contractor that can provide this requirement. As described in Section 6 above, market research, in accordance with FAR Part 10, was conducted by synopsis of the proposed acquisition, advising industry of the pending acquisition and soliciting inquiries from interested parties. Any Other Facts Supporting the Use of Other than Full and Open Competition: n/a Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: BTG/Biocompatibles, Inc., 115 Hurley Road, Bldg. 3, Oxford, Connecticut 06478 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 contracting office along with the medical facility will continue to conduct market research to determine if any new distributors enter the market. 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. _____________________________ ________________________ Marie Dean Date Nuclear Medicine Coordinator Louis Stokes Cleveland VA Medical Center Approvals in accordance with the VHAPM, Volume 6, Chapter VI: OFOC SOP. 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. _____________________________ ________________________ Gina P. Crank Date Contracting Officer Network Contracting Office (NCO) 10 Director of Contracting /Designee (Required over$150K but not exceeding $700K): I certify the justification meets requirements for other than full and open competition. _____________________________ ________________________ Connie A. McKay Date Branch Chief-Supply Team #2 Network Contracting Office (NCO) 10
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/CoVAOPC757/CoVAOPC757/VA25017N0753/listing.html)
 

Document(s)

Attachment
 

File Name: VA250-17-N-0753 VA250-17-N-0753.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=3617811&FileName=VA250-17-N-0753-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=3617811&FileName=VA250-17-N-0753-000.docx

 

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

Record

SN04559027-W 20170629/170627235211-6912167a453a210609bbff7761c465be (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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