Amendment 0001 120710.doc

Solicitation FDA_RFQ-1105617 Amendment 0001 The following questions have been asked by various Contractors in response to the original solicitation package:

1. The solicitation states that a “minimum frequency” of 900Mhz is required. Is 418Mhz permissible? What is the purpose for the frequency minimum?

Govt Response: The transmission frequency requirement is based on the following: more likely to provide superior communication transmission (distance), makes the system less susceptible to interference (background) from certain pieces of laboratory equipment, and provides for a simplified wireless system setup. Additionally, the physical building structure already provides issues for wireless cell phone transmissions that are generally at the lower frequency, and we feel that requiring the higher frequency will remove this as a possible system performance issue.

2. The solicitation states a “stand-alone” system. Please be more specific with the term. Does this mean the main host/server must be stand alone, or the entire wireless system must be stand alone? Can the system have networked receivers or base stations to transmit data?

Govt Response: In the simplest of terms, stand alone refers to the completeness of the system. From the Government’s standpoint we want to take it out of the box, have it installed and have it work within our laboratory structure. Further we want a system in which there is a proven track record of performance, provided by a company that can provide continued support through the lifetime of the instrumentation. The building is large and the instrumentation is varied and scattered throughout the facility. We need a system that provides high levels of precision, accuracy, is user friendly and flexible with regard to expansion to meet the lab needs. The requirements of any particular monitoring system proposed would have to be specified, so that its functionality could be fairly evaluated with regard to performance in our laboratory facility. Of one thing we are certain, we are not interested in any system that does not provide individual wireless data buffering at the probe level (see #3).

As for your specific question, access to the FDA network is highly restricted, and to consider a system that is network dependent would require pre-approval for universal compatibility prior to awarding of any contract for purchase. If your plan/proposal is to install a network to support the system you would be proposing, it would seem cost prohibitive.

3. The solicitation requires each sensor to buffer data. Is it possible for base-stations/receivers to buffer data rather than each individual sensor?

Govt Response: This requirement is based completely on what we consider to be the most reliable uniform data capture technology currently available that gives us the highest level of data integrity. With data capture at the probe level, if the probe malfunctions then we lose only the data associated with that probe. If there is a problem with transmission of the signal from a single probe the data still exists on the probe and I have the ability to recover it from that probe. However, if the data buffer is funneled through a centralized base station and that unit fails then we lose all data from all probes routed through that station with no possibility of retrieval (i.e. when it stops receiving then all probes routed there are essentially dead). This type of setup constitutes a very large risk for the laboratory data integrity, and maintaining our accreditation standards. While base stations may functionally capture data, we feel that they do not provide sufficient data integrity with regard to regulatory analytical requirements that we work under at this time.

4. Would it be possible to do a walk-through on the 19th of July?

Govt Response: No, see question #5 below.

5. Can the quote deadline be extended by one week to allow more time to prepare offers?

Govt Response: Unfortunately not. The requirement is needed right away and the Government cannot allow an extension to the bid deadline of 12 July, 2012 by 13:00 hours (Central Standard Time in Jefferson, Arkansas).