From: Meyer, Mary
Sent: Tuesday, July 13, 2004 2:10 PM
To: Butler, Jennie C
Subject: FW: FDA Docket 2004N-0133, Comments by America's Blood Centers

FDA Docket 2004N-0133, Comments by America's Blood Centers


Tks, Mary

-----Original Message-----
From: Amendt, Linda 
Sent: Tuesday, July 13, 2004 10:58 AM
To: Meyer, Mary; Swisher, Kathleen (CBER)
Subject: FW: FDA Docket 2004N-0133, Comments by America's Blood Centers


Does a copy of this go to you both?
Linda Amendt 
Special Assistant to the Director, OBRR 
FDA, Center for Biologics Eval. & Research 
301-827-3518/ Fax 301-827-3533 
email amendt@cber.fda.gov 

-----Original Message-----
From: Jane Starkey [mailto:jstarkey@americasblood.org]
Sent: Sunday, July 11, 2004 5:45 PM
To: epsteinj@cber.fda.gov
Subject: FW: FDA Docket 2004N-0133, Comments by America's Blood Centers


Dear Dr. Epstein,



For your information, here is a copy of the comments ABC filed last week on FDA Part 11 (Electronic Signatures; Electronic Records).



One of our main goals in our comments on Part 11 has been to emphasize that because each blood component distributed by blood centers comprises a “lot,” requirements for electronic signatures for lot release (and some other applications of Part 11) that may be quite appropriate for drug manufacturers would be exceedingly burdensome for the regulated blood industry.



Jane  



Jane Starkey

Director, Information Services

America's Blood Centers

Direct Telephone:  (202) 654-2904

ABC:  (202) 393-5725, ext. 2904

Fax:   (202) 393-5527

E-mail: jstarkey@americasblood.org



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-----Original Message-----
From: Jane Starkey 
Sent: Friday, July 09, 2004 3:50 PM
To: 'fdadockets@oc.fda.gov'
Subject: FDA Docket 2004N-0133, Comments by America's Blood Centers



Attached are comments by America’s Blood centers on the above docket.



We understand and agree that these comments may be posted for public access.



Jane Starkey

Director, Information Services

America's Blood Centers

725 15th Street, NW, Suite 700

Washington, DC 20005

Direct Tel:  (202) 654-2904

Fax:  (202) 393-5527