Radium 224 Isotope Generator

Contracting Office Address Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive RM 1E142, Rockville, MD 20892. Description The National Cancer Institute (NCI), Center for Cancer Research (CCR), Radiation Oncology Branch (ROB) plans to procure on a sole source basis with AREVA Med, LLC, One Bethesda Center, 4800 Hampden Lane Suite 1100, Bethesda, MD 20814 for three Radium-224 generators. This acquisition will be processed in accordance with simplified acquisition procedures as stated in FAR Part 13.106-1(b)(1). 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. Delivery Date: Delivery shall be for ninety (90) days after date of award. It has been determined there are no opportunities to acquire green products or services for this procurement. The Radiation Oncology Branch (ROB) of the National Cancer Institute (NCI) focuses on the biologic and therapeutic effect of radiation therapy. The research clinical trials that the ROB develops and conducts involve novel technology and imaging based approaches to radiation therapy treatment. Currently, Ra-224 generators are required for on-site production of the daughter radionuclide from the decay process, Pb-212, that the NCI has been using to perform extensive pre-clinical studies on disseminated colorectal disease animal model system. These experiments have defined not only Maximum Tolerated Doses (MTD) in this model but also produced significant extension of survival, and defined the impact of combination therapy with gemcitabine. Most recently the NCI has demonstrated not only the beneficial effects of combination therapy with paclitaxel, but also that administration order is a critical variable that had to be arrived at empirically. This same variable was radionuclide dependent as opposed to being a direct biological factor. To this end, the NCI has now actively translated the results into a Phase 1 clinical trial in collaboration with the University of Alabama, Birmingham with our CRADA partner, AREVAMed with an IND approved by the FDA in Feb. 2011. From that same IND approval, the NCI now possesses requirements for further studies as well as periodic stability measurements required by the FDA as well as transchelation studies and protein stability studies requisite to maintain and continue that same Phase 1 trial. To execute those studies there is a significant need of generators to validate both the cGMP production antibody conjugate as well as to continue to validate both facilities and SOPs. AREVA Med, LLC, has the same design and plumbing of the RA-224 generators in use for the phase one clinical trial at the University of Alabama at Birmingham; with the required quality and purity levels-clinical quality versus non-clinical quality. To maintain the performance characteristics in the collaborative efforts, the NCI will need to purchase from the same contractor to continue the integrity of the clinical trials. This is not a solicitation for competitive quotations. However, if any interested party, especially small businesses, believes they can meet the above requirement, they may submit a statement of capabilities. All information furnished must be in writing and must contain sufficient detail to allow the NCI to determine if it can meet the above unique specifications described herein. An original and one copy of the capability statement must be received in the NCI Office of Acquisitions on or before 11:00 AM EST on May 30, 2013. No electronic capability statements will be accepted (i.e. email or fax), an original and one copy must be sent to the NCI Office of Acquisitions to the address stated above. All questions must be in writing and can be faxed (240)276-5401 or emailed to Afua Serwah- Asibey, Contract Specialist at afua.serwah-asibey@nih.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. 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 have valid registration and certification in the Central Contractor Registration (CCR) and the Online Representations and Certifications Applications (ORCA), through sam.gov. No collect calls will be accepted. Please reference solicitation number N02RC32509-59 on all correspondence.