Attachment_III_-Government's_Responses_to_Questions.pdf

NIHES2015063, Government’s Responses to Questions

No. Reference Question Response

1. SOW, Section 4.2 Use of Biobide's automated image analysis system might be removed from the request. Has the specification been removed or does it remain a requirement? I've checked the Biobide website and there's no indication that the unit is currently available for purchase or even if it’s in a production model. I'm waiting to hear back from Biobide to see if we could obtain such a unit. Again related to the Biobide unit, if the objective of the program is to develop a means for rapid screening of products would development of an actual screening unit be included in the program. I've talked with contact at a local firm that specializes in hyperspectral imaging and analysis and they have expertise that would be directly related to this type of work and could develop a unit that would provide means for analysis of cardiotoxicity as described in Section 4.2 of the request.

See Amendment 000001 for changes. Language revised.

2. General Second question is related to the conduct of the assays.

When I've run GLP studies we normally document actual measured concentrations of our test products. For this study will actual measured concentrations of the product in the test solution be required or will "Nominal" concentrations be acceptable. Seeing you are running these studies as part of a preliminary program to assess the viability of the method I feel that nominal concentrations would be acceptable.

For the analysis of the test compounds, the NTP will be supplying the test articles and will perform the chemical analysis of the compounds.