SOURCES SOUGHT
66 -- A computer-controlled radiochemistry loop system, the AutoLoop APS-3100.
- Notice Date
- 9/11/2013
- Notice Type
- Sources Sought
- 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
- SS3027539
- 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
- I. Introduction and Purpose: This is a ‘Notice for Sources Sought' for commercial items prepared in accordance with the format in the Federal Acquisition Regulation (FAR) Part 10-Market Research, and, is supplemented with additional information. This is not a solicitation and request for proposals, proposal abstracts, and quotations. This is not an invitation for bids. This Government Issuing Agency and Contracting Office, on behalf of the Government Requiring Agency, seeks to obtain information regarding the interest and capability of any qualified business source to successfully meet the Government's requirements described in this notice. II. Business Interest and Capability: The purpose of this ‘Sources Sought Notice' is to allow any interested and capable business to identify itself and its capabilities. Thus, the Government is seeking capability statements from capable businesses including, but not limited to, the following types: 8(a), Veteran-Owned Small Business, Services-Disabled Veteran Owned Small Business, Historically Underutilized Business Zone Small Business, Small Disadvantaged Business, Women-Owned Small Business and Large Business. A business shall use its capability statement to demonstrate that: 1. The business possesses the capabilities to successfully meet the Government's requirements described in this notice; and, 2. The business is competitive in terms of quality, delivery, and market prices. Based on the business responses received, or not received, to this notice, the Government's requirements may be solicited as a 100% Full-and-Open Competition or a type of set-aside. III. 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. IV. Scope/Purpose/Objective: 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. 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. V. Government's Requirements and Need Description: The business shall demonstrate detailed knowledge, skill and capabilities regarding the elements and features essential to meet the Government's requirements and need description as follows: - The Government needs 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. - 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. - Technical information about the computer-controlled radiochemistry loop system, the AutoLoop APS-3100: Current PET imaging protocols using radioligands produced in this instrument include studies with [11C]PBR28 (subjects with epilepsy, MS, autism, traumatic brain injury, HIV or Alzheimer's disease), [11C]DPA713 (epilepsy), and [11C]Rolipram (depression). The synthesis of PET radiotracers using radioactive carbon-11 is a highly specialized process. The process used to produce many radioligands involves reacting volatile [11C]methyl iodide with a precursor compound in a very limited volume (<0.1 mL). This is accomplished by use of a stainless steel loop which must be absolutely clean and dry for the synthesis to succeed. There is no alternative method which can efficiently allow for such a concentrated reaction, and the reactions can be extremely sensitive to atmospheric conditions (air, moisture). VI. Period of Performance or/and Delivery Information: Delivery Within: 4 - 6 Weeks After Receipt of Order. VII. Response: 1. Any interested and capable business shall submit its capabilities statement tailored to this ‘Sources Sought Notice'. The capabilities statement shall clearly define the interested business' capabilities using an Adobe PDF or Microsoft Office document which limited to 15 pages total. Any interested and capable business shall ensure that its response is accurate, complete, and sufficiently detailed to allow the Government to assess the business' capabilities. The interested business' capabilities statement shall include the interested business' accurate and complete DUNS Number, Legal Business Name, "Doing Business as Name", Physical Address, Point of Contact Information, applicable North American Industry Classification System Code, Type of Business, and Business Size. Responses shall be submitted ONLY to Mario.Gray@nih.hhs.gov by the closing date of this ‘Sources Sought Notice'. 2. Respondents who believe that they are manufacturers or authorized resellers of the items specified in this announcement must provide as part of their response: 1. product, catalog, model, and/or part number(s); 2. product description(s); 3. all relevant information and documentation that the item(s) offered meet(s) the specification requirements: salient physical, functional, and performance characteristics, as specified in the specification requirements and item description section; 4. quantity; 5. estimated price or cost; 6. shipping, handling, and/or installation charges; and, 7. delivery date after receipt of order. VIII. Legal Considerations: The Government is under no obligation to acknowledge receipt of a response or to provide feedback to a response to this ‘Sources Sought Notice". This notice does not obligate the Government to award a contract or order to a respondent to this notice or pay for the information provided by a respondent to this notice. A respondent whom provides classified, confidential, proprietary, or/and sensitive information, does so entirely at its own risk and without the Government being subject to liability. The Government reserves the right to use information provided by any respondent for any purpose the Government deems appropriate and lawful. The Government reserves the right to use information provided by any respondent for any later announcement, notice, solicitation or/and synopsis.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIDA-01/SS3027539/listing.html)
- Place of Performance
- Address: bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN03183434-W 20130913/130911235437-5c2ede62b152c187aa60e748a322ac70 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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