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Account: An account is the means of accessing online information on specific submissions to the Food and Drug Administration (FDA). Creating an account gives you an account ID associated with your contact information so you can log onto FDA Industry Systems to manage your submissions online and keep your information secure. See also Subaccount.
Account ID: An alphanumeric string assigned to you by the system when you create an account. An account ID is needed to log in to the system to manage your submissions, e.g. register a food facility, submit prior notice, or change any of your account information. Also known as a User ID.
Agent in Charge: The agent in charge of a facility. The owner, operator, or agent in charge of a facility is responsible for registering a facility.
Cancelled Registration: If a registration is canceled, the facility is no longer registered. If the facility needs to be re-registered, a new registration will need to be created. A facility canceling its registration must do so within 60 calendar days of the reason for cancellation (e.g., facility ceases operations, ceases providing food for consumption in the U.S., or the facility is sold to a new owner). Failure to cancel a registration in accordance with this regulation is a prohibited act under section 301(dd) of the act (21 U.S.C. 331(dd)).
CFSAN: The FDA's Center for Food Safety and Applied Nutrition.
Domestic: Located in any State or Territory of the U.S., the District of Columbia, or the Commonwealth of Puerto Rico.
Emergency Contact Person: A contact person who can be reached 24 hours a day, 7 days a week, in case of an emergency. FDA will contact a foreign facility's U.S. agent when an emergency occurs, unless the registration specifies another emergency contact.
Facility: Facility means any establishment, structure, or structures under one ownership at one general physical location, or, in the case of a mobile facility, traveling to multiple locations, that manufactures/processes, packs, or holds food for consumption in the U.S. Transport vehicles are not facilities if they hold food only in the usual course of business as carriers. A facility may consist of one or more contiguous structures, and a single building may house more than one distinct facility if the facilities are under separate ownership. The private residence of an individual is not a facility. Non-bottled water drinking water collection and distribution establishments and their structures are not facilities.
FDA: The U.S. Food and Drug Administration.
FDA Industry Systems (FIS): An online collection of FDA programs integrated to allow one login to access many FDA systems. (See FDA Industry Systems Home Page.)
FDA Food Facility Registration Module (FFRM): An online program that allows domestic and foreign facilities that manufacture/process, pack, or hold food for human or animal consumption in the United States the ability to register their food-handling facilities with FDA via the Internet.
FDA Unified Registration and Listing System (FURLS): A major subset of FDA Industry Systems. FURLS was created in part due to to the Bioterrorism Act, which, among other requirements, requires that FDA develop a system for registering food facilities by December 12, 2003. FURLS will be expanded to provide central access to all FDA registration and listing systems. (See FDA Industry Systems Home Page.)
FFRM: See Food Facility Registration Module
FIS: See FDA Industry Systems
Food Facility Registration: See Registration of Food Facilities.
Foreign: Located outside a State or Territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico.
FURLS: See FDA Unified Registration and Listing System.
Industry Systems: See FDA Industry Systems.
Operator: The operator of a facility. The owner, operator, or agent in charge of a facility is responsible for registering the facility.
ORA: FDA's Office of Regulatory Affairs
Owner: The owner of a facility. The owner, operator, or agent in charge of a facility is responsible for registering the facility.
PIN: A Personal Identification Number (PIN) is a case sensitive alphanumeric string assigned to you by the system. If this PIN is kept secret it provides a secure way of keeping registration information from being accessed by unauthorized users. The PIN will enable the account holder to allow another authorized account holder to link to an existing food facility registration.
Registration Number: The registration number is the number assigned to a food facility that is required to register with the FDA.
Registration of Food Facilities: A new U.S. regulation (see Fact Sheet) published October 10, 2003, in response to the Bioterrorism Act, which, among other requirements, requires domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States to register with the FDA by December 12, 2003.
Subaccount: The Subaccount is a limited access account that is offered as an option for companies that require additional personnel to manage submissions to FDA. An Account holder may create one or more Subaccounts with varying levels of authority to help manage submissions. See also Account.
U.S. Agent: A U.S. agent is a person physically located in the United States who is designated by a foreign food facility as its agent for purposes of FDA's registration requirements. The U.S. agent acts as a communications link between FDA and the foreign facility for routine communications. FDA will contact the U.S. agent when an emergency occurs unless the registration specifies another Emergency Contact Person.
User ID: See Account ID.
