SAMDaily.us | SNOTE | 68 | FDA Notice of Intent to Award Sole Source: 3D Imaging Drug and Development, LLC; 17 deliveries of a time-sensitive radiotracer [18F] dansylhydrazone of p-fluorobenzaldehyde (DFNSH)

SAMDAILY.US - ISSUE OF MAY 12, 2022 SAM #7468
SPECIAL NOTICE

68 -- FDA Notice of Intent to Award Sole Source: 3D Imaging Drug and Development, LLC; 17 deliveries of a time-sensitive radiotracer [18F] dansylhydrazone of p-fluorobenzaldehyde (DFNSH)

Notice Date: 5/10/2022 1:51:42 PM
Notice Type: Special Notice
Contracting Office: FOOD AND DRUG ADMINISTRATION Rockville MD 20841 US
ZIP Code: 20841
Solicitation Number: FDA_NOI_SS_1253185
Response Due: 5/25/2022 12:00:00 PM
Point of Contact: Tim Walbert, Phone: 8705437267
E-Mail Address: timothy.walbert@fda.hhs.gov
(timothy.walbert@fda.hhs.gov)
Small Business Set-Aside: SBA Total Small Business Set-Aside (FAR 19.5)
Description: The U.S. Food and Drug Administration (FDA) intends to award a firm fixed price purchase order to 3D Imaging Drug and Development LLC, 9015 CARTI Way, Little Rock, Arkansas, under the authority of FAR 13.106-1(b)(1). NCTR Division of Neurotoxicology requires 16 deliveries of a time-sensitive radiotracer [18F] dansylhydrazone of p-fluorobenzaldehyde (DFNSH), plus one initial test synthesis, for a total of 17 radiotracers. These radioactive-labeled tracer syntheses shall be utilized to accomplish in vivo, non-invasive scanning to characterize transient and permanent neural responses via different types of intervention including chemical and biological compounds in rats. �Neuro-imaging experiments, with the use of a Siemens Inveon microPET/CT Scanner, will be directed toward neuro-imaging of live subjects and will contribute to ongoing studies in characterizing immediate neuronal expression and compound effects within the brain structures of rats. The critical specification of this requirement is the availability of a local facility capable of delivering the required DFNSH radiotracers within less than two hours of synthesis.� The availability of a radioactive labeled tracer contract synthesized locally and delivered quickly (the tracer has an approximate half-life of two hours) is required for immediate use under current NCTR scientific protocols employing the aforementioned Siemens Inveon MicroPET/CT and its application to in vivo monitoring of neuronal apoptosis.� This notice is being published in accordance with Federal Acquisition Regulation (FAR) Part 5.101(a)(2) requiring the dissemination of information on proposed contract actions. This is a notice of intent to award a sole source contract and is not a request for competitive proposals. The statutory authority for this sole-source procurement is FAR 13.106-1(b)(1). This notice of intent is not a request for competitive proposals. Responsible sources who believe they may submit a capability statement to Tim Walbert at timothy.walbert@fda.hhs.gov on or before May 25, 2022 at 2:00 pm Central Time (CT). A determination not to compete this requirement, based upon responses to this notice, is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. No phone calls will be accepted.
Web Link: SAM.gov Permalink
(https://sam.gov/opp/180fa8745ed746edb2f474f042f573ff/view)
Place of Performance: Address: USA; Country: USA
Record: SN06322179-F 20220512/220510230051 (samdaily.us)
Source: SAM.gov Link to This Notice
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68 -- FDA Notice of Intent to Award Sole Source: 3D Imaging Drug and Development, LLC; 17 deliveries of a time-sensitive radiotracer [18F] dansylhydrazone of p-fluorobenzaldehyde (DFNSH)