Docket Management
Docket: 97D-0318 - Revised Preventive Measures to Reduce Transmission of Creutzfeldt-Jakob Disease (CJD) by Blood
Comment Number: EC -7

Accepted - Volume 3

Comment Record
Commentor Dr. Celso Bianco Date/Time 2001-09-19 15:04:14
Organization America's Blood Centers
Category Association

Comments for FDA General
1. General Comments Dear Docket Officer: On behalf of America's Blood Centers (ABC), I am requesting an extension until October 12 of the September 28 deadline for comments on the Food and Drug Administration's draft guidance on additional measures to reduce the possible transmission of Creutzfeldt-Jakob disease and variant Creutzfeldt-Jakob disease (Docket 97D-0318). Due to the extraordinary events of the last week and the continued stress on the nation's blood collection system as a result of the terrorist attacks on New York City and Washington, DC, ABC regulatory affairs staff as well as our Scientific, Medical and Technical Committee have been unable to focus our attention on providing comments on this important new donor deferral policy. Since this new donor deferral policy will have a major impact on blood center operations and on the blood supply as a whole, we believe that it is essential that we provide careful and detailed comments to the Center for Biologics Evaluation and Research. We request a two-week extension of the comment period (until October 12) to provide us with the time to prepare and submit our comments. Yours truly, Celso Bianco, MD Executive Vice President America's Blood Centers

EC -7