[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1.234]

[Page 22-23]
 
                        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.  1.234  How and when do you update your facility's registration information?

    (a) Update requirements. The owner, operator, or agent in charge 
must submit an update to a facility's registration within 60 calendar 
days of any change to any of the information previously submitted under 
Sec.  1.232 (e.g., change of operator, agent in charge, or U.S. agent), 
except a change of the owner. The owner, operator, or agent in charge 
may authorize an individual to update a facility's registration.
    (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 Sec.  1.235 within 60 
calendar days of the change and the new owner must re-register the 
facility as specified in Sec.  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) Once you complete your electronic update, FDA will automatically 
provide you with an electronic confirmation of your update.
    (3) Your registration will be considered updated once FDA transmits 
your update confirmation, unless notified otherwise.
    (d) Update 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 update your facility's registration by mail 
or by fax:
    (1) You must update your registration using Form 3537. 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 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 or

1-800-573-0846.
    (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, along with CD-ROM submissions, 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).
    (6) If any update information you previously submitted was incorrect 
at the time of submission, you must immediately resubmit your update.
    (7) 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.

[[Page 23]]

    (e) Update by CD-ROM for multiple submissions. If, for example, you 
do not have reasonable access to the Internet through any of the methods 
provided under Sec.  1.231(a), you may update your facilities' 
registrations by CD-ROM.
    (1) Registrants submitting their updates in CD-ROM format must use 
ISO 9660 (CD-R or CD-RW) data format.
    (2) Update files must be submitted on a PDF rendition of FDA's 
registration form (Form 3537) and be accompanied by one signed copy of 
the certification statement on the registration form (Form 3537).
    (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 updates for as many facilities as needed 
up to the CD-ROM's capacity.
    (5) The update 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 an update 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 update submissions into its registration 
system, along with the complete and legible mailed and faxed update 
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 update(s) as entered and confirmation of 
the update.
    (10) If any update information you previously submitted was 
incorrect at the time of submission, you must immediately resubmit your 
update.
    (11) 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.

[68 FR 58960, Oct. 10, 2003 as amended at 73 FR 15883, Mar. 26, 2008]