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FBO DAILY - FEDBIZOPPS ISSUE OF JULY 10, 2016 FBO #5343
DOCUMENT

65 -- Notice of Intent to award a Sole Source, Firm Fixed Price contract to PETNET Solutions, Inc., subsidiary of Siemens Medical Solutions USA, 810 Innovation Drive, Knoxville, TN on July 18, 2016 for Amyvid (Florbetapir F 18 Injection). - Attachment

Notice Date

7/8/2016
 

Notice Type

Attachment
 

NAICS

325412 — Pharmaceutical Preparation Manufacturing
 

Contracting Office

Contracting Officer (90C);Department of Veterans Affairs;Ralph H. Johnson VA Medical Center;109 Bee Street;Charleston SC 29403-5799
 

ZIP Code

29403-5799
 

Solicitation Number

VA24716N0821
 

Archive Date

10/15/2016
 

Point of Contact

Janica Francis-Hunter
 

E-Mail Address

ment
 

Small Business Set-Aside

N/A
 

Description

The Department of Veterans Affairs, Ralph H Johnson VAMC, Network Contracting Office 7, intends to award a Sole Source, Firm Fixed Price (FFP) contract to PETNET Solutions, Inc., subsidiary of Siemens Medical Solutions USA, 810 Innovation Drive, Knoxville, TN 37932 on July 18, 2016. The Period of Performance includes one base year and four option years extending to December 2020. The value of the contract is expected to be $660,000. The proposed contract action; for which the Government intends to solicit and negotiate with only one source under authority of FAR 6.302, is for the acquisition of Amyvid (Florbetapir F 18 Injection) to perform a variety of nuclear medicine diagnostic procedures vital to patient care. Amyvid belongs to a group of drugs called diagnostic radiopharmaceuticals. It is a radioactive agent that allows images of specific organs in the body to be detected by a PET (Positron Emission Tomography) scan. Amyvid is used together with a PET scan to detect the amount of plaque in the brain. Plaque is a build-up of certain proteins and diseased nerve cells that is often found in the brain of a person who has signs of Alzheimer's disease or other causes of dementia. The following is in support of Sole Source award: 1. Amyvid is the only radioactive diagnostic agent approved by the US Food and Drug Administration (FDA) for PET imaging of the brain to estimate beta-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer's disease and other causes of cognitive decline. Once Amyvid is injected into a vein, it travels through the bloodstream and into the brain, binding to amyloid plaques, one of the necessary pathological features of Alzheimer's disease. Amyvid produces a positron signal, which is detected by a PET scanner and used to create a brain image. A specially trained radiologist interprets the image to evaluate for the presence or absence of significant amyloid plaques (i.e., moderate to frequent levels of neuritic plaques) in the brain. A negative Amyvid scan indicates sparse to no amyloid plaques are currently present, which is inconsistent with a neuropathological diagnosis of Alzheimer's disease and reduces the likelihood that a patient's cognitive impairment is due to Alzheimer's disease. A positive Amyvid scan indicates moderate to frequent amyloid plaques are present; this amount of amyloid plaque is present in patients with Alzheimer's disease. This information is reported back to the referring physician, who then determines the next steps in the evaluation and management of the patient. 2. Amyvid is a proprietary PET biomarker owned by drug maker Eli Lilly. PETNET Solutions Inc. entered into a long-term non-exclusive agreement with Eli Lilly and Company in November 2011 to manufacture and distribute Amyvid throughout the United States. Siemens's PETNET Solutions is the only national commercial manufacturer to submit and gain approval for an ANDA for fludeoxyglucose F18 injection (18F FDG). 3. Amyvid must be distributed directly to imaging centers from the specialized radiopharmacies where it is produced because loses over half of its radioactivity every two hours. PETNET Solutions is the only manufacturer and distributor of FDG within a 150 miles radius of the Ralph H Johnson VAMC. A justification for Other than Full and Open competition has been prepared in support of this acquisition. The government intends to solicit and negotiate with only one source under the authority of Federal Acquisition Regulations (FAR) 6.302.1. Only one responsible source and no other supplies will satisfy agency requirements. This notice is not a Request for Quote (RFQ) or a Request for Proposal (RFP). Information received will be considered solely for the purpose of determining whether conducting a competitive procurement is in the best interest of the government. Interested parties may identify their interest and capability to respond to the requirement, or submit capability statements by responding to this notice no later than 9:00 a.m. (EST) on July 15, 2016 via e-mail to Janica.Francis@gov. All information submitted should support the offerors capability to provide the radioactive drug required, and shall be furnished at no cost or obligation to the government. The primary North American Industry Classification System (NAICS) code is 325412- Pharmaceutical Preparation Manufacturing, with a small business standard of 1,250 employees. Point of Contact: Janica Francis-Hunter Contract Specialist Phone: 843-789-6448 Fax: 843-789-6406 Janica.Francis@va.gov
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/ChaVAMC/VAMCCO80220/VA24716N0821/listing.html)
 

Document(s)

Attachment
 

File Name: VA247-16-N-0821 VA247-16-N-0821.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2861412&FileName=VA247-16-N-0821-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2861412&FileName=VA247-16-N-0821-000.docx

 

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

Record

SN04175744-W 20160710/160708234201-daec658f947640dfbd09b288a2fe70d9 (fbodaily.com)
 

Source

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

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