SOLICITATION NOTICE
X -- GMP Storage of Monoclonal Antibodies under GMP Conditions for Clinical Trials
- Notice Date
- 10/6/2006
- Notice Type
- Solicitation Notice
- NAICS
- 493120
— Refrigerated Warehousing and Storage
- 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, MD, 20852
- ZIP Code
- 20852
- Solicitation Number
- Reference-Number-NCI-70003-NV
- Response Due
- 10/16/2006
- Archive Date
- 10/30/2006
- Description
- The National Cancer Institute (NCI), Center for Cancer Research (CCR), Metabolism Branch (MB) plans to enter into a sole source procurement for GMP Storage and Delivery of Clinical Grade GMP Reagents with Fisher BioServices Inc., 14665 Rothgeb Drive, Rockville, MD 20850, for a one year base period with two one-year option periods. The North American Industry Classification System Code is 493120 and the business size standard is $23.5M. This acquisition will be processed under FAR Part 12 - Acquisition for Commercial Items and will be made pursuant to the authority in FAR 13.5 to use simplified procedures for commercial acquisitions. In its effort to bring new drugs successfully into the clinic, drugs developed in the MB are contracted to be made under Good Manufacturing Practices (GMP) to meet FDA standards for use in clinical trials involving human patients. These drugs must be stored at -70 degrees under FDA GMP regulations at a GMP approved facility that is within five hour drive of the NIH Clinical Center Hospital. The facility must be within five hours should a need arise on an emergency basis in order to treat a patient on protocol. Any deviation from this specification could ruin countless hours of Government effort spent in drug development, manufacturing costs and testing and could invalidate critical clinical trials and or patient health. Fisher BioServices is the only vendor known to the NCI researcher that is within a five hour trip of the NCI Clinical Center that has a GMP approved facility and can store clinical materials at -70 degrees under FDA GMP regulations. This is not a request for competitive quotation. However, if any interested party believes it can perform the above requirement, it may submit a statement of capabilities. The statement of capabilities and any other furnished information must be in writing and must contain material in sufficient detail to allow the NCI researcher to determine if the party can perform this requirement. An original and one copy of the capability statement must be received in the contracting office by 1:00 pm EDT, on October 16, 2006. Faxed and emailed capability statements are NOT authorized. All questions must be in writing and may be emailed to Debbie Moore at dm170b@nih.gov or faxed (301) 402-4513. It is the vendor?s responsibility to call (301) 402-4509 and verify that questions were received. 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 order to register. In addition, contractors must be registered in the Central Contractor Registration (CCR) www.ccr.gov. No collect calls will be accepted.
- Record
- SN01162576-W 20061008/061006220207 (fbodaily.com)
- Source
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