21 CFR 1.235 - How and when do you cancel your facility's registration information?

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§ 1.235 How and when do you cancel your facility's registration information?

(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.

[ 81 FR 45952, July 14, 2016]

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

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United States Code

Title 21 published on 2015-12-03

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 1 after this date.

  • 2016-12-27; vol. 81 # 248 - Tuesday, December 27, 2016
    1. 81 FR 95068 - Questions and Answers Regarding Food Facility Registration (Seventh Edition); Revised Draft Guidance for Industry; Availability
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Notification of availability.
      Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that we consider your comment on the revised draft guidance before we begin work on the final version of the guidance, submit either electronic or written comments on the revised draft guidance by March 27, 2017.
      21 CFR Part 1
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