RESPONSE_TO_CONTRACTOR_QUESTIONS.pdf

FDA’s Response to Questions from Contractors

1. On p3 of the SOW, under item one of the Scope section, the phrase “<1% (w/w)” asbestos is used. How does the FDA intend for “(w/w)” to be interpreted?

RESPONSE: The 1% (w/w) value represents the weight of asbestos found per unit weight of the sample prior to sample preparation. The 1% was cited to indicate we are looking at amounts that are less than those typically being looked for the analysis of asbestos containing bulk materials (ACMs).

2. On p4 of the SOW, under bullet points for Task 1-Kick Off Meeting, one of the bullet points says “the criteria for categorizing countable fibers into “asbestiform” and “non-asbestiform” fiber populations.” Does the FDA have specific criteria that they would like for the successful bidder to use?

RESPONSE: FDA is asking the bidder to propose criteria for differential counting of structures recognizing that current definitions in published methods might not necessarily be applicable to the fibers that might be found in milled talc powders.

3. On page five of the SOW, under analysis of demonstration samples, the FDA says it will provided demonstration and reference samples representing asbestiform and non-asbestiform. What is the criteria used to classify the asbestos into either category?

RESPONSE: The demonstration samples will have been tested by another lab which provided its opinion as to the asbestiform nature of fibers. The reference materials represent amphibole populations that were obtained from Research Triangle Institute with the understanding that classification as either asbestiform or non-asbestiform was primarily on the basis of particle length and width. Data for length and width will be provided with the reference standards.

4. There are very few instructions as how the FDA would like responses formatted. Should the price & experience proposals be submitted as separate files from the price proposal? Is there a minimum or maximum length of response?

RESPONSE: Please Provide two volumes. Volume I shall consist of the technical portion and Volume II shall include the Price portion. Proposals should be limited to 25 pages maximum.

5. We don’t see the amendment posted on FBO.

RESPONSE: The amendment posted on 8/30/18 was to extend the proposal response date until 11:30am EST 9/11/2018