Amendment_002-QandA.pdf

FDA-17-SOL-1186710 – Amendment 0002 Page 1 of 1 Precision and Analytical Lab Balance PM and Calibrations

Solicitation Section Questions and Government Responses Part 3, Specific Requirements, #2j

Unsure as to what you are referencing with pan supports and plastic spacers. Do you have part numbers or images?

Response: Example: Oahu’s Ohaus Part#11108115

Part 3, Specific Requirements, #3

The question is how will FDA determine if scale is out of spec? What testing parameters will the FDA use (are you testing the limit of capacity, what is your process for testing)? Is it possible to share part of your SOP that will be used to determine if a scale is out of spec?

Response: FDA will determine if a scale is out of spec if the scale does not meet manufacturer's specifications on calibrations. The labs perform a daily mass accuracy check with a NIST traceable weight. FDA would use this to determine if the balance was out of specification. FDA performs a reference weight check. On a daily basis the user has a calibrated weight that is used to check the balance. It may bracket the area of weights they want to measure or it may be a single weight. It is not possible for FDA to share part of our SOP used to determine if a scale is out of spec.

Part 10 – Instruction to the Offeror

Is winning bid required to service all sites at the agreed upon rate, or can there be site/location specific bids?

Response: The FDA is requesting a firm fixed-price for each balance unit certification and preventative maintenance together without differentiation based upon manufacturer of the balance or geographic location of service.