The National Cancer Institute (NCI) plans to procure on a sole source basis for two Miltenyi Biotec autoMACS Pro Starting Kits which include: autoMACS Pro Separator, a minisampler with lid, 1-5, 15, and 50mL tube racks, buffer combi pack, autoMACS columns, and user manual, setup & installation, training, and a one year warranty with Miltenyi Biotec, Inc., 12740 Earhart Ave., Auburn CA 95602.

This acquisition will be processed in accordance with simplified acquisition procedures as stated in FAR 13.106-(b)(1) The North American Industry Classification System Code is 334516 and the business size standard is 500 employees.

We are proposing to purchase a Miltenyi Biotec autoMACS Pro separator which is an automated magnetic separation system. The separator isolates specific sub-populations of cells or viruses from larger heterogeneous populations. This is important to our research for developing new cytokine and antibody mediated therapies against infections diseases. This system is required so that we may isolate and collect cells expressing specific antigens to test the efficacy of our therapeutic strategies without compromising their functionality or viability. It is also important that the device protects the operators from being exposed to potentially infectious microbes.

The following salient characteristics apply to the autoMACS Pro Separator:
• Enable users to isolate or enrich cells expressing specific antigens that can be used for subsequent biological tests;
• Automated cell isolation with pre-programmed isolation protocols;
• Integrated computer with touch screen;
• Capable of automatically processing up to six (6) samples sequentially each with its own protocol;
• Uses biodegradable 50nm super-paramagnetic Microbeads (Iron) coated with a polysaccharide and present in a colloidal suspension to prevent clumping and clogging;
• Microbeads are directly conjugated to monoclonal antibodies directed against various antigens, fluorochromes, or avidin-biotin molecules;
• Allow users to collect specific cells depending on surface antigen expression from mice, tissue, or cell lines for assays without exposing the operators to potentially infectious microbes;
• Ability to enrich tumor cells expressing certain antigen, and used for antibody-targeting therapies;
• Patented columns: dual super-paramagnetic, bio-Teflon coated matrix columns - reusable over a 2-week period or up to 100 separations, whichever comes first.

PART II. Facts and Reasons To Justify Other than Full And Open Competition

1. Statute: 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).

2. Sole Source Justification

The Miltenyi Biotec autoMACS Pro separator is the only known system that can meet the needs of the NCI. The autoMACS Pro separator is already widely used throughout the NIH and NCI. It has been cited in numerous scientific papers demonstrating its acceptance by the research community. The autoMACS apparatus is only distributed by Miltenyi Biotec Inc. The instrumentation and reagent content related to the autoMACS is proprietary and protected under patent rights and is thereby unavailable from any other sources.

This is not a solicitation for competitive quotations. However, if any interested party believes they can meet the above requirement, 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 NCI contracting office by 1:00 PM ET on July 31, 2008. All questions must be in writing and can be faxed (301) 402-4513 or emailed to Melissa Marino, Contract Specialist at marinome@mail.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) www.ccr.gov and the Online Representations and Certifications Applications (ORCA), http://orca.bpn.gov. No collect calls will be accepted. Please reference NCI-80119-MM on all correspondence.