Form 3540 Prior Notice Submission

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FDA Industry Systems

System Status

Food Facility Registration Module

Login � New Account � More Information � FFRM Help

Form 3537/3537a OMB Approval Number: 0910-0502 OMB Expiration Date: 01/31/2007 See OMB Burden Statement

Prior Notice System Interface

Login � New Account � More Information � PNSI Help

Form 3540 OMB Approval Number: 0910-0520 OMB Expiration Date: 01/31/2007 See OMB Burden Statement

Low Acid Canned Foods

Login � New Account � More Information � LACF Help

Form 2541/2541a/2541c OMB Approval Numbers: 0910-0037 OMB Expiration Dates: 06/30/2008 See OMB Burden Statement

Electronic Submission Gateway

� New Account Gateway Information and Help

Account Management

� Account Management Help

Help Desk

FDA Industry Systems / Technical Help

Electronic Submissions Gateway Approved Production Transaction Partners, Food Facility Registration Module, Prior Notice, Low Acid & Acidified Canned Foods, and Account Management.

Phone: 1-800-216-7331 or 301-575-0156 7:30 a.m.-11:00 p.m. Eastern Time
Fax: 301-210-0247
e-mail questions about the Bioterrorism Act: Use this form

Effective January 14, 2004: The FDA Industry System Help Desk is available for technical assistance with online registration and listing systems, Prior Notice, and regulated electronic submissions on U.S. Government business days (Monday to Friday, excluding U.S. government holidays) from 7:30 a.m. to 11:00 p.m. Eastern Time. (See Federal Holidays and Federal Government Operating Status.)

You may leave a message or send e-mail at other times. These will be addressed on the next business day.

Prior Notice / Policy Help

Phone: 1-866-521-2297

The Prior Notice Center staff can answer questions about Prior Notice policies, procedures, and interpretations 24 hours a day, 7 days a week.

Electronic Submissions Gateway / Pre-Production Help

If you want to become a trading partner, or have a question about becoming
a trading partner, for the Electronic Submissions Gateway, please visit the
FDA Electronic Submissions Gateway web page.

Additional Information FDA Registration, Listing, or Notification Programs Voluntary Cosmetic Registration Program Blood Establishment Registration and Product Listing Human Cell and Tissue Establishment Registration and Product Listing Drug Registration and Listing Medical Device Registration and Listing for Firms Other FDA Industry Information Information for FDA-Regulated Industry Information Materials for the Food and Cosmetics Industries ORA Industry Assistance Small Business Guide to FDA Cosmetics - Information for Industry Food Ingredients and Packaging - Information for Industry Over the Counter Drug Products - Industry Information Medical Devices and Radiation-Emitting Electronic Products Food Labeling and Nutrition - Information for Industry

FDA Industry Systems (FIS) was created to facilitate making submissions to the U.S. Food and Drug Administration (FDA), including registrations, listings, and other notifications. FIS has been available 24 hours a day, seven days a week, since October 16, 2003 6:00 p.m. EDT. FIS was created, in part, in response to the Bioterrorism Act of 2002, which gave high priority to improved information management to help protect the food supply. The Act requires that FDA develop two systems: one to support the registration of facilities that manufacture, process, pack, or hold food products intended for consumption in the United States and one to receive prior notice before food is imported or offered for import into the United States. Under the law, facilities must be registered by December 12, 2003 when Prior Notice went into effect.

Computer System Requirements:

1. Internet Access: Internet access is widely available, including at public libraries and Internet cafes.
2. Web Browser: The following web browsers are supported for these applications on MS Windows XP and 2000. They may or may not work in other versions of Windows.
   • Microsoft Internet Explorer: Versions 5.5, 6.0 (supported in FFRM and PNSI)
   • Netscape Navigator: Version 7.1 (supported in FFRM and PNSI)
   • Opera: Version 7.0 (supported in FFRM only)
   • Mozilla Firefox (supported in PNSI only)
3. Additional hints
   • Clear Browser Cache

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FDA Industry Systems Website Staff
October 24, 2006