SOLICITATION NOTICE
66 -- a computer-controlled radiochemistry loop system, the AutoLoop APS-3100.
- Notice Date
- 9/17/2013
- Notice Type
- Presolicitation
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, 6001 Executive Boulevard, Room 4211 - MSC 9559, Bethesda, Maryland, 20892, United States
- ZIP Code
- 20892
- Solicitation Number
- PS3027539
- Point of Contact
- Mario D. Gray, Phone: 3014352238
- E-Mail Address
-
Mario.Gray@nih.hhs.gov
(Mario.Gray@nih.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- INTRODUCTION: THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A PURCHASE ORDER WITHOUT PROVIDING FOR FULL AND OPEN COMPETITION. The National Institute on Drug Abuse (NIDA), Station Support Contracts and Simplified Acquisitions Branch (SS/SA), on behalf of the National Institute of Mental Health (NIMH), intends to negotiate and award a purchase order, without providing for full and open competition, to Eckert & Ziegler Radiopharma Incorporated (Eckert & Ziegler) for a computer-controlled radiochemistry loop system, the AutoLoop APS-3100. NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE: The intended procurement is classified under NAICS Code 334516 with a Size Standard of 500 Employees. REGULATORY AUTHORITY: The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2005-69 effective September 3, 2013. This acquisition is conducted under the procedures as prescribed in the FAR subpart 13-Simplified Acquisition Procedures at an amount not exceeding the simplified acquisition threshold ($150,000). STATUTORY AUTHORITY: This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13-Simplified Acquisition Procedures, Subpart 13.106-1 (b) (1), Soliciting from a single source and is not expected to exceed the simplified acquisition threshold. Acquisitions using FAR Part 13-Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6-Competition Requirements. Government's Requirements and Need Description: The contractor shall provide a computer-controlled radiochemistry loop system, the AutoLoop APS-3100 which: 1. Meets the FDA standards for production of radiotracers that will be injected into human subjects, the process should be computer-controlled and monitored to ensure reproducibility and accuracy of process data recording; and, 2. Allows reproductability and reliability of the process is essential: the half-life of carbon-11 is only 20 minutes so the timing of receiving the radioactivity, performing the reaction, formulating the radiotracer, and injecting the final product into the waiting subject is critical. Background: The PET Radiochemistry Section of the Molecular Imaging Branch of NIMH produces a wide variety of radiolabeled compounds for PET brain imaging of human subjects in ongoing NIH clinical trials, as well as for the supporting research and animal studies. The AutoLoop system is a widely used, highly efficient system which we are currently using for the radiolabeling of compounds with [11C]methyl iodide and [11C]methyl triflate. This is a critical instrument in our laboratory which has been heavily used for over 10 years. Purpose and Objectives: The computer-controlled radiochemistry loop system, the AutoLoop APS-3100, is a critical instrument in our laboratory which has been heavily used for over 10 years. Obtaining an additional AutoLoop system will allow us to double our research and production capacity for radiotracers using this methodology, and to provide an essential backup system in the event that the current aging system requires repair so that our clinical trials may continue without interruption and allow capacity for an anticipated expansion of our laboratory space and production for human subjects under cGMP (current Good Manufacturing Practice) standards. Period of Performance or/and Delivery Information/Contract Type: Delivery Information: Delivery Within: 4 - 6 Weeks After Receipt of Order. Project Description: The purchased item will be used for production of radioligands for currently ongoing and future clinical PET brain imaging studies within the Molecular Imaging Branch of NIMH. The equipment must be highly reliable and fully supported commercial instrument which will be used daily for radiolabeling organic compounds with [11C]methyl iodide and [11C]methyl triflate. Acquisition includes delivery and installation of the instrument. The purchased instrument will be delivered to the NIMH facility and installed by the manufacturer's certified installation technician at a date to be determined later by NIMH. Installation will include full setup of the instrument and performance testing. Manufacturer will provide NIMH with full documentation of the instrument and of the installation, verification, and IQ/OQ validation. Any difficulties in installation, verification, or validation will be resolved by the NIMH and the installer as soon as possible, and contact information for future repair needs and parts supply will be provided. Other Important Considerations: Not Applicable CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION: The determination by the government to award a purchase order without providing for full and open competition (including brand-name) is based upon market research conducted as prescribed in FAR Part 10-Market Research, specifically the review and evaluation of responses received to the sources sought notice published in the FedBizOpps on September 11, 2013. The results of the market research concluded that there are no other companies with the capability of providing a computer-controlled radiochemistry loop system, the AutoLoop APS-3100 which possesses the elements and features essential to meet the Government's requirements. The Government already owns a computer-controlled radiochemistry loop system, the AutoLoop APS-3100, which is a critical laboratory instrument and which has been heavily used for over 10 years. The Government is expanding its radiosynthesis capabilities into an FDA cGMP-regulated facility to ensure the highest standards of product quality and must have a system which can reproduce the Government's existing methods as explicitly defined in the FDA-approved IND applications. To redevelop the synthesis methods for a different apparatus would result in significant downtime of the synthesis and therefore interruption of the ongoing clinical studies. The Government requires an identical computer-controlled radiochemistry loop system, the AutoLoop APS-3100, to allow for production of radiotracers under FDA-regulated cGMP conditions. Therefore, only Eckert & Ziegler has the capability to provide a computer-controlled radiochemistry loop system, the AutoLoop APS-3100 which possesses the elements and features essential to meet the Government's requirements. CLOSING STATEMENT: This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice. Responses to this notice shall contain sufficient information to establish the interested parties' bona-fide capabilities for fulfilling the requirement and include: unit price, list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov." A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement. All responses must reference the identifier code as follows: PS3027539. All responses must be submitted electronically to the Contract Specialist, Mario Gray, using the e-mail address as follows: Mario.Gray@nih.hhs.gov, and, by the closing date and time of this notice. Fax responses will not be accepted.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIDA-01/PS3027539/listing.html)
- Place of Performance
- Address: Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN03190802-W 20130919/130917235326-faf88889d059c2833634c00f2c33a643 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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