Notice Regarding The Submission Of FCE
Forms To The FDA

This news report appeared in the IFT Weekly Newsletter,
published by the Institute of Food Technologists at http://www.ift.org/extra/newsletter/index.html

Wednesday, October 24, 2001

As a result of recent disruptions in the United States Postal system, effectively immediately, alternative options in submitting Food Canning Establishment (FCE) Registration Forms (FDA 2541) and Process filing forms (FDA 2541a and FDA 2541c) are now available.

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 (202)205-4121

and the e-mail 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 202/ 205-5282.