Form 3540 Prior Notice Submission

Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002

US FDA Industry Systems 3540 Screenshot.htm

21 CFR 1.282, 1.283(a)(5)- Prior Notice Cancellation Through The PN Systen Interface. Regulation Sets Forth Cancellation Requirements & Information That the Prior Notice ... .

OMB: 0910-0520

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US FDA Industry Systems
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U.S. Department of Health and Human Services
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FDA Industry Systems

 

Food Facility Registration Module

Prior Notice System Interface

Low Acid Canned Foods

Electronic Submission Gateway

Account Management

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
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