(a) Registration. You must register before your facility begins to manufacture, process, pack, or hold food for consumption in the United States. You may authorize an individual to register the facility on your behalf.

(b) Registration renewal. You must submit a registration renewal containing the information required under § 1.232 every other year, during the period beginning on October 1 and ending on December 31 of each even-numbered year. You may authorize an individual to renew a facility's registration on your behalf. If the individual submitting the registration renewal is not the owner, operator, or agent in charge of the facility, the registration renewal must also include a statement in which the individual certifies that the information submitted is true and accurate, certifies that he/she is authorized to submit the registration renewal, and identifies by name, address, and telephone number, the individual who authorized submission of the registration renewal. In addition, the registration renewal must also identify the individual who authorized submission of the registration renewal by email address, unless FDA has granted a waiver under § 1.245. Each registration renewal must include the name of the individual submitting the registration renewal, and the individual's signature (for the paper option). Each electronic registration renewal must include the name of the individual submitting the renewal.

(c) Abbreviated registration renewal process. If you do not have any changes to the information required under § 1.232 since you submitted the preceding registration, registration renewal, or update for your facility, you may use the abbreviated registration renewal process. If you use the abbreviated registration renewal process, you must confirm that no changes have been made to the information required under § 1.232 since you submitted the preceding registration, registration renewal or update, and you must certify that the information submitted is truthful and accurate. Each abbreviated registration renewal must include the name of the individual submitting the abbreviated renewal, and the individual's signature (for the paper option). Each electronic abbreviated registration renewal must include the name of the individual submitting the abbreviated renewal. For abbreviated registration renewals not submitted by the owner, operator, or agent in charge of the facility, the abbreviated renewal must provide the email address of the individual who authorized submission of the abbreviated renewal, unless FDA has granted a waiver under § 1.245. You must use Form FDA 3537 to submit abbreviated registration renewals to FDA.

(a) Electronic registration and registration renewal. (1) To register or renew a registration electronically, you must go to http://www.fda.gov/furls, which is available for registration 24 hours a day, 7 days a week. This Web site is available from wherever the Internet is accessible, including libraries, copy centers, schools, and Internet cafes. An individual authorized by the owner, operator, or agent in charge of a facility may also register a facility electronically.

(2) Beginning on January 4, 2020, you must submit your registration or registration renewal to FDA electronically, unless FDA has granted you a waiver under § 1.245.

(3) After you submit your electronic registration, FDA will verify the accuracy of your unique facility identifier (UFI) recognized as acceptable by FDA and will also verify that the facility-specific address associated with the UFI is the same address associated with your registration. FDA will not confirm your registration or provide you with a registration number until FDA verifies the accuracy of your facility's UFI and verifies that the facility-specific address associated with the UFI is the same address associated with your registration. With respect to electronic registration renewals, after you submit your electronic registration renewal, FDA will provide you with an electronic confirmation of your registration renewal. When you update your facility's UFI as part of your electronic registration renewal, FDA will verify the accuracy of your facility's UFI and will also verify that the facility-specific address associated with the UFI is the same address associated with your registration. FDA will not provide you with a confirmation of your registration renewal until FDA verifies the accuracy of your UFI and verifies that the facility-specific address associated with the UFI is the same address associated with your registration.

(4) For electronic registrations not submitted by the owner, operator, or agent in charge of the facility, after submission of the registration, FDA will verify that the individual identified as having authorized submission of the registration in fact authorized the submission on behalf of the facility. FDA will not confirm the registration or provide a registration number until that individual confirms that he or she authorized the submission. With respect to electronic registration renewals, after completion of the electronic registration renewal, FDA will provide an electronic confirmation of the registration renewal. For electronic registration renewals not submitted by the owner, operator, or agent in charge of the facility, FDA will verify that the individual identified as having authorized submission of the registration renewal in fact authorized the submission on behalf of the facility. FDA will not provide an electronic confirmation of the registration renewal until that individual confirms that he or she authorized the submission.

(5) For a foreign facility, after you submit your electronic registration, FDA will verify that the person identified as the U.S. agent for your foreign facility has agreed to serve as your U.S. agent. FDA will not confirm your registration or provide you with a registration number until that person confirms that the person agreed to serve as your U.S. agent. With respect to electronic registration renewals, after you complete your electronic registration renewal, FDA will provide you with an electronic confirmation of your registration renewal. When you update information about your U.S. agent as part of your electronic registration renewal, FDA will verify that the person identified as the U.S. agent for your foreign facility has agreed to serve as your U.S. agent. FDA will not provide you with an electronic confirmation of your registration renewal until that person confirms that the person agreed to serve as your U.S. agent.

(6) If any information you previously submitted was incorrect at the time of submission, you must immediately update your facility's registration as specified in § 1.234.

(7) You will be considered registered once FDA electronically sends you your confirmation and registration number.

(b) Registration or registration renewal by mail or fax. Beginning January 4, 2020, you must submit your registration or registration renewal to FDA electronically, unless FDA has granted you a waiver under § 1.245. If FDA has granted you a waiver under § 1.245, you may register or renew a registration by mail or by fax.

(1) You must register or renew a registration (including abbreviated registration renewals) using Form FDA 3537. You may obtain a copy of this form by writing to the U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5001 Campus Dr. (HFS-681), College Park, MD 20740 or by requesting the form by phone at 1-800-216-7331 or 301-575-0156.

(2) When you receive the form, you must fill it out completely and legibly and either mail it to the address in paragraph (b)(1) of this section or fax it to 301-436-2804.

(3) If any required information on the form is incomplete or illegible when FDA receives it, FDA will return the form to you for revision, provided that your mailing address or fax number is legible and valid. When returning a registration form for revision, FDA will use the means by which the form was received by the Agency (i.e., by mail or fax).

(4) FDA will enter complete and legible mailed and faxed registration submissions into its registration system, as soon as practicable, in the order FDA receives them.

(5) After you submit your registration, FDA will verify the accuracy of your facility's UFI and will also verify that the facility-specific address associated with the UFI is the same address associated with your registration. FDA will not confirm your registration or provide you with a registration number until FDA verifies the accuracy of your facility's UFI and verifies that the facility-specific address associated with the UFI is the same address associated with your registration. With respect to registration renewals, after you submit your registration renewal by mail or fax, FDA will provide you with a confirmation of your registration renewal. When you update your facility's UFI as part of your registration renewal, FDA will verify the accuracy of your facility's UFI and will also verify that the facility-specific address associated with the UFI is the same address associated with your registration. FDA will not provide you with a confirmation of your registration renewal until FDA verifies the accuracy of your UFI and verifies that the facility-specific address associated with the UFI is the same address associated with your registration.

(6) For registrations not submitted by the owner, operator, or agent in charge of the facility, after submission of the registration by mail or fax, FDA will verify that the individual identified as having authorized submission of the registration in fact authorized the submission on behalf of the facility. FDA will not confirm the registration or provide a registration number until that individual confirms that he or she authorized the submission. With respect to registration renewals, after completion of the registration renewal by mail or fax, FDA will provide a confirmation of the registration renewal. For registration renewals not submitted by the owner, operator, or agent in charge of the facility, FDA will verify that the individual identified as having authorized submission of the registration renewal in fact authorized the submission on behalf of the facility. FDA will not provide a confirmation of the registration renewal until that individual confirms that he or she authorized the submission.

(7) For a foreign facility, after you submit your registration by mail or fax, FDA will verify that the person identified as the U.S. agent for your foreign facility has agreed to serve as your U.S. agent. FDA will not confirm your registration or provide you with a registration number until that person confirms that the person agreed to serve as your U.S. agent. With respect to registration renewals, after you complete your registration renewal by mail or fax, FDA will provide you with a confirmation of your registration renewal. When you update information about your U.S. agent as part of your registration renewal, FDA will verify that the person identified as the U.S. agent for your foreign facility has agreed to serve as your U.S. agent. FDA will not provide you with a confirmation of your registration renewal until that person confirms that the person agreed to serve as your U.S. agent.

(8) FDA will mail or fax you a copy of the registration as entered, confirmation of registration, and your registration number. When responding to a registration submission, FDA will use the means by which the registration was received by the Agency (i.e., by mail or fax).

(9) If any information you previously submitted was incorrect at the time of submission, you must immediately update your facility's registration as specified in § 1.234.

(10) Your facility is considered registered once FDA enters your facility's registration data into the registration system and the system generates a registration number.

(c) Fees. No registration fee is required.

(d) Language. You must submit all registration information in the English language except an individual's name, the name of a company, the name of a street, and a trade name may be submitted in a foreign language. All information, including these items, must be submitted using the Latin (Roman) alphabet.

(a) For a domestic and foreign facility, the following information is required:

(1) The name, full address, and phone number of the facility;

(2) Beginning October 1, 2020, the facility's UFI recognized as acceptable by FDA;

(3) The preferred mailing address, if different from that of the facility;

(4) The name, full address, and phone number of the parent company, if the facility is a subsidiary of the parent company;

(5) All trade names the facility uses;

(6) The name, full address, and phone number of the owner, operator, or agent in charge of the facility. In addition, the email address of the owner, operator, or agent in charge is required, unless FDA has granted you a waiver under § 1.245;

(7) The applicable food product categories of any food manufactured/processed, packed, or held at the facility as identified on Form FDA 3537;

(8) The type of activity conducted at the facility for each food product category identified. You may select more than one activity type for each food product category identified. The activity type options are as follows:

(i) Ambient human food storage warehouse/holding facility;

(ii) Refrigerated human food warehouse/holding facility;

(iii) Frozen human food warehouse/holding facility;

(iv) Interstate conveyance caterer/catering point;

(v) Contract sterilizer;

(vi) Labeler/relabeler;

(vii) Manufacturer/processor;

(viii) Acidified food processor;

(ix) Low-acid food processor;

(x) Farm mixed-type facility;

(xi) Packer/repacker;

(xii) Salvage operator (reconditioner);

(xiii) Animal food warehouse/holding facility;

(xiv) Other activity.

(9) A statement in which the owner, operator, or agent in charge provides an assurance that FDA will be permitted to inspect the facility at the times and in the manner permitted by the Federal Food, Drug, and Cosmetic Act;

(10) A statement in which the owner, operator, or agent in charge certifies that the information submitted is true and accurate. If the individual submitting the form is not the owner, operator, or agent in charge of the facility, the registration must also include a statement in which the individual certifies that the information submitted is true and accurate, certifies that he/she is authorized to submit the registration, and identifies by name, address, and telephone number, the individual who authorized submission of the registration. In addition, the registration must identify the individual who authorized submission of the registration by email address, unless FDA has granted a waiver under § 1.245. Each registration must include the name of the individual submitting the registration, and the individual's signature (for the paper option).

(b) For a domestic facility, the following additional information is required:

(1) The email address for the contact person of the facility;

(2) An emergency contact phone number and email address if different from the email address for the contact person in paragraph (b)(1) of this section.

(c) For a foreign facility, the following additional information is required:

(1) The name, full address, phone number, and email address of the foreign facility's U.S. agent;

(2) An emergency contact phone number and email address.

Yes. FDA encourages, but does not require, you to submit items that are indicated as optional on the Form FDA 3537 that you submit.

(a) Update requirements. You must update a facility's registration within 60 calendar days of any change to any of the information previously submitted under § 1.232 (e.g., change of operator, agent in charge, or U.S. agent), except a change of the owner. You may authorize an individual to update a facility's registration on your behalf. For updates not submitted by the owner, operator, or agent in charge of the facility, the update must provide the email address of the individual who authorized submission of the update, unless FDA has granted a waiver under § 1.245.

(b) Cancellation due to ownership changes. If the reason for the update is that the facility has a new owner, the former owner must cancel the facility's registration as specified in § 1.235 within 60 calendar days of the change and the new owner must submit a new registration for the facility as specified in § 1.231. The former owner may authorize an individual to cancel a facility's registration.

(c) Electronic update. (1) To update your registration electronically, you must update at http://www.fda.gov/furls.

(2) After you submit your electronic update, FDA will provide you with an electronic confirmation of your update. When updating UFI information, FDA will verify the accuracy of your facility's UFI and will also verify that the facility-specific address associated with the UFI is the same address associated with your registration. FDA will not provide you with an electronic confirmation of your registration update until FDA verifies the accuracy of your facility's UFI and verifies that the facility-specific address associated with the UFI is the same address associated with your registration. For foreign facilities, when updating information about your U.S. agent, FDA will verify that the person identified as the U.S. agent for your foreign facility has agreed to serve as your U.S. agent. FDA will not provide you with an electronic confirmation of your registration update until that person confirms that the person agreed to serve as your U.S. agent.

(3) For electronic updates not submitted by the owner, operator, or agent in charge of the facility, after submission of the electronic update, FDA will verify that the individual identified as having authorized submission of the update in fact authorized the submission on behalf of the facility. FDA will not confirm the update to the registration until that individual confirms that he or she authorized the submission.

(4) Your registration will be considered updated once FDA sends you your update confirmation, unless notified otherwise.

(d) Update by mail or fax. Beginning January 4, 2020, you must submit your update electronically, unless FDA has granted you a waiver under § 1.245. If FDA has granted you a waiver under § 1.245, you may update your facility's registration by mail or by fax.

(1) You must update your registration using Form FDA 3537. You may obtain a copy of this form by writing to the U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5001 Campus Dr. (HFS-681), College Park, MD 20740 or by requesting the form by phone at 1-800-216-7331 or 301-575-0156.

(2) When you receive the form, you must legibly fill out the sections of the form reflecting your updated information and either mail it to the address in paragraph (d)(1) of this section or fax it to 301-436-2804.

(3) If the information on the form is incomplete or illegible when FDA receives it, FDA will return the form to you for revision, provided that your mailing address or fax number is legible and valid. When returning a registration form for revision, FDA will use the means by which the registration was received by the Agency (i.e., by mail or fax).

(4) FDA will enter complete and legible updates into its registration system as soon as practicable, in the order FDA receives them.

(5) FDA will then mail to the address or fax to the fax number on the registration form a copy of the update as entered and confirmation of the update. When responding to an update submission, FDA will use the means by which the form was received by the Agency (i.e., by mail or fax). After you submit your update by mail or fax, FDA will verify the accuracy of your facility's UFI and will also verify that the facility-specific address associated with the UFI is the same address associated with your registration. FDA will not provide a confirmation of your registration update until FDA verifies the accuracy of your facility's UFI and verifies that the facility-specific address associated with the UFI is the same address associated with your registration. For foreign facilities, when updating information about your U.S. agent, FDA will verify that the person identified as the U.S. agent for your foreign facility has agreed to serve as your U.S. agent. FDA will not provide you with a confirmation of your registration update until that person confirms that the person agreed to serve as your U.S. agent.

(6) For registration updates not submitted by the owner, operator, or agent in charge of the facility, after submission of the registration update by mail or fax, FDA will verify that the individual identified as having authorized submission of the update in fact authorized the submission on behalf of the facility. FDA will not confirm the registration update until that individual confirms that he or she authorized the update.

(7) If any update information you previously submitted was incorrect at the time of submission, you must immediately resubmit your update.

(8) Your registration will be considered updated once FDA enters your facility's update data into the registration system and the system generates an update confirmation.

(a) Notification of registration cancellation. You must cancel a registration within 60 calendar days of the reason for cancellation (e.g., your facility ceases operations, ceases providing food for consumption in the United States, or is sold to a new owner).

(b) Cancellation requirements. The cancellation of a facility's registration must include the following information:

(1) The facility's registration number;

(2) Whether the facility is domestic or foreign;

(3) The facility name and address;

(4) The name, address, and email address (if available) of the individual submitting the cancellation;

(5) For registration cancellations not submitted by the owner, operator, or agent in charge of the facility, the email address of the individual who authorized submission of the registration cancellation, unless FDA has granted a waiver under § 1.245; and

(6) A statement certifying that the information submitted is true and accurate, and that the person submitting the cancellation is authorized by the facility to cancel its registration.

(c) Electronic cancellation. (1) To cancel your registration electronically, you must cancel at http://www.fda.gov/furls.

(2) Once you complete your electronic cancellation, FDA will provide you with an electronic confirmation of your cancellation.

(3) For registration cancellations not submitted by the owner, operator, or agent in charge of the facility, after submission of the registration cancellation, FDA will verify that the individual identified as having authorized submission of the cancellation in fact authorized the submission on behalf of the facility. FDA will not confirm the registration cancellation until that individual confirms that he or she authorized the registration cancellation.

(4) Your registration will be considered cancelled once FDA sends you your cancellation confirmation.

(d) Cancellation by mail or fax. Beginning January 4, 2020, you must cancel your registration electronically, unless FDA has granted you a waiver under § 1.245. If FDA has granted a waiver under § 1.245, you may cancel your facility's registration by mail or fax.

(1) You must cancel your registration using Form FDA 3537a. You may obtain a copy of this form by writing to the U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5001 Campus Dr. (HFS-681), College Park, MD 20740 or by requesting the form by phone at 1-800-216-7331 or 301-575-0156.

(2) When you receive the form, you must completely and legibly fill out the form and either mail it to the address in paragraph (d)(1) of this section or fax it to 301-436-2804.

(3) If the information on the form is incomplete or illegible when FDA receives it, FDA will return the form to you for revision, provided that your mailing address or fax number is legible and valid. When returning a cancellation form for revision, FDA will use the means by which the cancellation was received by the Agency (i.e., by mail or fax).

(4) FDA will enter complete and legible mailed and faxed cancellations into its registration system as soon as practicable, in the order FDA receives them.

(5) FDA will mail to the address or fax to the fax number on the cancellation form a copy of the cancellation as entered and confirmation of the cancellation. When responding to a cancellation, FDA will use the means by which the form was received by the Agency (i.e., by mail or fax).

(6) For registration cancellations not submitted by the owner, operator, or agent in charge of the facility, after submission of the registration cancellation by mail or fax, FDA will verify that the individual identified as having authorized submission of the cancellation in fact authorized the submission on behalf of the facility. FDA will not confirm the registration cancellation until that individual confirms that he or she authorized the registration cancellation.

(7) Your registration will be considered cancelled once FDA enters your facility's cancellation data into the registration system. FDA will send you your cancellation confirmation.