ResponseFDA1058936.pdf

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Attached to
Laboratory Mice Federal contract opportunity
Solicitation number
FDA1058936
Issued by
Department of Health and Human Services Food and Drug Administration

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FDA response to vendor questions.

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Response to Questions for FDA1058936

Vendor Questions:

1) No term for the project – is this one time or recurring?

2) No need by date – is there a particular date?

3) No ship to location – where do you need the product?

4) Product: 392 mice ( Tg PVR21/IQI ) not sure what this strain is, could you please clarify?

FDA Response:

1) FDA will confirm when the batch shipments of mice should take place with the final delivery by no later than 9/30/2009.

2) FDA shall specify the delivery date.

3) The ship to location is mentioned as Bethesda, MD 20892.

4) TgPVR21/IQI mouse strain is currently well known strain which several companies use now for control of oral live poliovirus vaccine neurovirulence (OPV). These mice were engineered by Japanese scientist Dr. Akio Nomoto in 1991. Basing on multi-years collaborative study these mouse strain was approved by the WHO Expert Committee on Biological Standardization in year 2002 (WHO Tech Rep,, No.904, Geneva, 2002). Vendors should have WHO clearance for these mice.

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