SOLICITATION NOTICE
66 -- IGG100 Gallium-68 Generator
- Notice Date
- 8/1/2008
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 334510
— Electromedical and Electrotherapeutic Apparatus Manufacturing
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 6120 Executive Blvd., EPS Suite 600, Rockville, Maryland, 20852
- ZIP Code
- 20852
- Solicitation Number
- NCI-80158-NG
- Archive Date
- 9/2/2008
- Point of Contact
- Malinda L Holdcraft,, Phone: (301) 402-4509, Caren N Rasmussen,, Phone: (301) 402-4509
- E-Mail Address
-
holdcram@exchange.nih.gov, cr214i@nih.gov
- Small Business Set-Aside
- N/A
- Description
- The National Cancer Institute (NCI), Center for Cancer Research (CCR), Molecular Imaging Section of Radiation Oncology Branch (MISROB), Mammary Biology and Tumorigenesis Laboratory (MBTL) plans to procure on a sole source basis the IGG100 Gallium-68 Generator with Eckert & Zeigler Eurotope; Robert-Rossle-Str 10; Berlin 13125 DEU. 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 334510 the business size standard is 500 employees. The Molecular Imaging Section of Radiation Oncology Branch, CCR, improves the efficiency of radiotherapy by combining gradiation with optimized targeted therapy and adjustment of the treatment to individual patients using non-invasive methods of tumor characterization. The goal of the NCI is to utilize multidisciplinary approach engaging systems biology, molecular imaging, and nanotechnology to develop individualized approach to treatment of breast cancer involving assessment of target presence and distribution in an individual patient followed by optimized, target-specific drug delivery. The Eckert & Zeigler IGG100 Gallium-68 Generator is designed to minimize both Gb68 breakthrough and metal impurities. The IGG100 Gallium-68 Generator is shipped in a ready-to-use condition with both the inlet and outlet lines using Luer female connections with attached caps that facilitate easy installation to the Mammary Biology and Tumorigenesis Laboratory (MBTL). Eckert & Ziegler Eurotope GmbH has developed a validated 68 Ga peptide synthesis process. The following salient characteristics apply to the IGG100 Gallium-68 Generator : The metallic cation 68 Ga(III) readily forms stable complexes with DOTA (1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraacetic acid) modified Affibody molecules and positron emitter, Allows peptides and other small molecules to be radiolabled at high specific activities, 68 Ga has a positron yield as high as 89% of all disintegrations, Half-life of 68 minutes is compatible with the pharmacokinetics of peptides of interest in diagnostic imaging and therapy, 271 day half-life of the parent, 68 Ge isotope allows the use of the 68 Ge/ 68 Ga generator for up to one year without access to a cyclotron, and IGG100 Gallium-68 Generator offers low breakthrough and light weight. PART II: Facts and Reasons to Justify Other than Full and Open Competition Statute: This justification has been prepared under the authority of 41 U.S.C. 253 (c)(1) as set forth in 13.106-1 (b)(1). (b) Soliciting from a single source (1) For purchases not exceeding the simplified acquisition threshold, contracting officers may solicit from one source if the contracting officer determines that the circumstances of the contract action deem only one source reasonably available (e.g., urgency, exclusive licensing agreements, or industrial mobilization). No other requirement and/or type for supply or service will satisfy agency need. Eckert & Zeigler is the only known company that manufactures a 68 Ga generator for the U.S. market. The major advantage of the IGG100 model is a significantly lower Ge-68 breakthrough, at about a factor of 10. This is important because Ge-68 has a long half-life, about 270 days, so it would persist in the organism being studied which is necessary for the clinical studies being performed by the Mammary Biology and Tumorigenesis Laboratory (MBTL) in the Molecular Imaging Section of Radiation Oncology Branch (MISROB). There is no other source known to the NCI that can complete this requirement. This is not a solicitation for competitive quotations. However, if any interested party believes it can perform the requirement as detailed they may submit a statement of capabilities. All information furnished shall 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 contracting office by 11:00 am EDT, on August 18, 2008. All questions must be in writing and must be emailed to Malinda Holdcraft at holdcram@mail.nih.gov faxed to (301) 402-4513. 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 from the NCI contractors must be registered in the Online Representations and Certifications Applications (ORCA). Please refer to http://orca.bpn.gov In addition; contractors must be registered in the Central Contractor Registration (CCR) www.ccr.gov. No collect calls will be accepted. Please reference NCI-80158-NG on all correspondence.
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- Record
- SN01629337-W 20080803/080801222928-1b7a85f4a893afeb15647fa4973480c6 (fbodaily.com)
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