Docket Management
Docket: 97D-0318 - Revised Preventive Measures to Reduce Transmission of Creutzfeldt-Jakob Disease (CJD) by Blood
Comment Number: EC -6

Accepted - Volume 1

Comment Record
Commentor Dr. Peter Wojciechowski Date/Time 2001-09-13 10:29:39
Organization Centocor Inc
Category Individual

Comments for FDA General
1. General Comments The draft guideline mentions inactivation of TSE infectivity in 1N NaOH at room temperature (29-31 deg C). The temperature range given is not consistent with normal room temperature range of ~18-22 deg C. Either the term room temperature is incorrectly used or the range given needs to be revised. Sincerely, Peter W. Wojciechowski, Principal Research Scientist Centocor Inc.

EC -6