[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1.231]

[Page 19-20]
 
                        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. 1.231  How and where do you register?

    (a) Electronic registration. (1) To register electronically, you 
must register at http://www.fda.gov/furls, which is available for 
registration 24 hours a day, 7 days a week. This website 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) FDA strongly encourages electronic registration for the benefit 
of both FDA and the registrant.
    (3) Once you complete your electronic registration, FDA will 
automatically provide you with an electronic confirmation of 
registration and a permanent registration number.
    (4) You will be considered registered once FDA electronically 
transmits your confirmation and registration number.
    (b) Registration by mail or fax. If, for example, you do not have 
reasonable access to the Internet through any of the methods described 
in paragraph (a) of this section, you may register by mail or fax.
    (1) You must register 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 fill it out completely and 
legibly and either mail it to the address in paragraph (b)(1) of this 
section or fax it to 301-210-0247.
    (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, 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 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).
    (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 Sec. 1.234.
    (7) 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) Registration 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 paragraph (a) of this section, you may 
register by CD-ROM.
    (1) Registrants submitting their registrations in CD-ROM format must 
use ISO 9660 (CD-R or CD-RW) data format.
    (2) These files must be submitted on a portable document format 
(PDF) rendition of the registration form (Form 3537) and be accompanied 
by one signed copy of the certification statement that appears 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) A CD-ROM may contain registrations for as many facilities as 
needed up to the CD-ROM's capacity.
    (5) The registration on the CD-ROM for each separate facility 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 the U.S. Food and Drug 
Administration (HFS-681), 5600 Fishers Lane, Rockville, MD 20857.

[[Page 20]]

    (7) If FDA receives a CD-ROM that does not comply with these 
specifications, it will return the CD-ROM to the submitter unprocessed.
    (8) FDA will enter CD-ROM submissions that comply with these 
specifications into its registration system, along with the 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 registration(s) as entered, confirmation 
of registration, and each facility's assigned registration number.
    (10) If any information you previously submitted was incorrect at 
the time of submission, you must immediately update your facility's 
registration as specified in Sec. 1.234.
    (11) Your facility is considered registered once FDA enters your 
facility's registration data into the registration system and the system 
generates a registration number.
    (d) Fees. No registration fee is required.
    (e) 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.