[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1.235]

[Page 23-24]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 1_GENERAL ENFORCEMENT REGULATIONS--Table of Contents
 
                Subpart H_Registration of Food Facilities
 
Sec.  1.235  How and when do you cancel your facility's registration 

information?

    (a) Notification of registration cancellation. 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 United States, or the facility 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 e-mail address (if available) of the 
individual submitting the cancellation; and
    (5) 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 
automatically provide you with an electronic confirmation of your 
cancellation.
    (3) Your registration will be considered cancelled once FDA 
transmits your cancellation confirmation.
    (d) Cancellation by mail or fax. If, for example, you do not have 
reasonable access to the Internet through any of the methods described 
in Sec.  1.231(a), you may cancel your facility's registration by mail 
or fax.
    (1) You must cancel your registration using Form 3537a. You may 
obtain a copy of this form by writing to the U.S. Food and Drug 
Administration (HFS-681), 5600 Fishers Lane, Rockville, MD 20857, or by 
requesting the form by phone at 1-877-FDA-3882 (1-877-332-3882).
    (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 301-210-0247.

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    (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, along with CD-ROM 
cancellations, 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 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) If any information you previously submitted was incorrect at the 
time of submission, you must immediately resubmit your cancellation.
    (7) Your registration will be considered cancelled once FDA enters 
your facility's cancellation data into the registration system and the 
system generates a confirmation.
    (e) Cancellation by CD-ROM for multiple submissions. If, for 
example, you do not have reasonable access to the Internet through any 
of the methods described in Sec.  1.231(a), you may cancel your 
facilities' registrations using a CD-ROM.
    (1) Registrants submitting their cancellations in CD-ROM format must 
use ISO 9660 (CD-R or CD-RW) data format.
    (2) Cancellation files must be submitted on a PDF rendition of the 
cancellation form (Form 3537a) and be accompanied by one signed copy of 
the certification statement on the cancellation form.
    (3) Each submission on the CD-ROM must contain the same preferred 
mailing address in the appropriate block on Form 3537.
    (4) The CD-ROM may contain cancellations for as many facilities as 
needed up to the CD-ROM's capacity.
    (5) The cancellation for each facility on the CD-ROM must have a 
unique file name up to 32 characters long, the first part of which may 
be used to identify the parent company.
    (6) You must mail the CD-ROM to U.S. Food and Drug Administration 
(HFS-681), 5600 Fishers Lane, Rockville, MD 20857.
    (7) If FDA receives a CD-ROM that does not comply with these 
specifications, it will return the CD-ROM to the registrant unprocessed.
    (8) FDA will enter CD-ROM submissions that meet the specifications 
into its registration system, along with complete and legible mailed and 
faxed submissions, as soon as practicable, in the order FDA receives 
them.
    (9) For each facility on the CD-ROM, FDA will mail to the preferred 
mailing address a copy of the cancellation(s) as entered and 
confirmation of the cancellation.
    (10) If any information you previously submitted was incorrect at 
the time of submission, you must immediately resubmit your cancellation.
    (11) Your registration will be considered cancelled once FDA enters 
your facility's cancellation data into the registration system and the 
system generates a confirmation.

                          Additional Provisions