FDA_RFQ_1207869_Amendment_0001.doc

FDA-RFQ-1207869 Amendment 0001 Histology Services and Pathology Analysis to Support Studies on

Drug-Induced Neurotoxicity in the Brain

Part 1 – Description

The purpose of this amendment is to provide questions and answers for the RFQ.

Part 2 – Questions and Answers

1. Question: Based on the description of services I was wondering if this work needs to be performed under a GLP condition? It does not appear to be listed as such in the solicitation document so am assuming it is non-GLP.

Answer: The work does not have a GLP requirement. It is non-GLP.

2. Question: A typical block holds 16. Should we assume that one shipment will need a minimum of two blocks? The price for each block is static so the more blocks (even if not filled with 16 brains, the cost will be based on a per block basis. Can you verify the number of blocks they expect needing per year?

Answer: A single shipment could be anywhere from 1 – 3 blocks depending on how many brains need to be analyzed and how rapidly we need the results. We expect that 3 blocks will be needed per year.

3. Questions: On the document, line item called "pathology report", I am assuming this should also include the price for review of the slides. Is that correct?

Answer: That is correct. The pathology review and report are included in the price.

Part 3 – Response Date

Response Date remains unchanged

RFQ Due Date: All quotes shall be submitted via email to Christine Russman at Christine.Russman@fda.hhs.gov before 2:00 PM Eastern Time on 7 December 2018.

All other terms and conditions remain unchanged.

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