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This acquisition will be processed in accordance with simplified acquisition procedures as stated in FAR Part 13.106-1(b) (1) and is exempt from the requirements of FAR Part 6. The North American Industry Classification System code is 325413 and the business size standard is 500 employees.
Only one award will be made as a result of this solicitation. This will be awarded as a firm fixed price type contract.
First delivery shall be made within thirty (30) days after receipt of award.
It has been determined there are no opportunities to acquire green products or services for this procurement.
This acquisition is for six (6) Ra-224 generators for the onsite production of the daughter radionuclide from the decay process, Pb-212. The Pb-212 is then used to label monoclonal antibodies for radio immunotherapy studies. A Phase 1 clinical trial has been expanded to an additional site at the University of California at San Diego and the purchased Ra-224 generators will allow the ROB to support this clinical trial as well as further develop and refine the use of Pb-212 for the treatment and management of cancer patients. To execute this clinical trial and further studies, ROB requires Ra-224 generators to validate both cGMP production antibodconjugate as well as to continue to validate both ROB's facilities and SOPs, but to also facilitate transferal of that same information and ability to the clinical site at the University of Alabama at Birmingham, in Birmingham, AL.
The most critical characteristics and requirements of these generators is that they are consistent with those previously prepared for and used by the Chemistry Section for their animal model pre-clinical therapy studies. Activity levels of 15-20 mCi is a minimal amount of Ra-224 that has to be on the generators such that adequate amounts of Pb-212 can be provided. The design and plumbing of those generators needs to be as reliable as that previously associated with those generators previously prepared for and used by the Radioimmune & Inorganic Chemistry Section (RICS) for their animal model pre-clinical therapy studies. A generator that is 15-20 mCi in a generator design that matches what has been previously used by the RICS, is absolutely essential.
In addition, a guaranteed production schedule of every two (2) weeks is vital, as it allows for the planning and execution of complex experiments and for the optimization of treatment schedules which will most likely involve more than one treatment with ROB's Pb-212 labeled monoclonal antibodies.
Lastly, local production capabilities of Ra-224, with a relatively short shipping distance, are absolutely crucial, as Ra-224 is a half-life of 3.7 days. Relatively local production means that in addition to less decay of the Ra-224, less damage has occurred to the generator, which compromises its useful life. UT-Battelle Memorial Institute, as the Management & Operations contractor of the Oak Ridge National Laboratory, meets all of the vital qualifications above.
This notice is not a request for competitive quotation. However, if any interested party, especially small businesses, believes it can meet the above requirement, it may submit a capability statement, proposal, or quotation, which shall be considered by the agency. The statement of capabilities and any other information furnished must be in writing and must contain material in sufficient detail to allow NCI to determine if the party can perform the requirement. Responses must be received in the contracting office by 11:00 AM EDST, on August 26, 2014. All responses and questions must be in writing and emailed to Kelly Dempsey, Contracting Officer via electronic mail at [email protected]. A determination by the Government not to compete this proposed 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. In order to receive an award, contractors must be registered and have valid certification in the System for Award Management (www.sam.gov). Reference: N02RC43803-91 on all correspondence.