Forms can be submitted to FDA via FAX or e-mail. In submitting forms via these methods, the transmitted forms must be clear and legible to be accepted. Also, forms submitted via e-mail should be submitted as file attachments along with any additional supporting information. All forms must be signed. Electronic signatures complying with 21 CFR 11 are acceptable. For more information on electronic signatures see: http://www.access.gpo.gov/nara/cfr/waisidx_01/21cfr11_01.html
The firm or its authorized representative should maintain original hard copies, as these may be requested at a later date. FDA suggests that firms keep receipts of faxes or copies of email transmissions with original forms. These transmitted forms will be viewed as official submissions. The FAX number for transmitting forms is (301) 436-2669 (if busy, try (301) 436-2655) and the email address is lacf@cfsan.fda.gov
For those who would prefer to submit of original copies of forms, the use of special courier services should be considered.
Should you have any further questions, please contact the LACF Registration Coordinator at 301 436-2411.
Hypertext updated by dms/ear/cjm 2002-APR-02