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FDA is allowing registrants to submit their registrations on paper by mail or FAX or by CD-ROM. FDA will enter these submissions into its registration system as soon as practicable, in the order received.
FDA strongly encourages electronic registration via the Internet, which will be quicker and more convenient than registration by paper or CD-ROM for both facilities and FDA.
Regardless of the mode of submission, each registration must include the name and contact information for the facility and its parent company (if applicable); all trade names the facility uses; applicable food product categories as identified in 21 CFR 170.3; name and contact information for the owner, operator, or agent in charge, a statement certifying that the information submitted is true and accurate and that the person submitting the registration is authorized by the facility to register on its behalf; and if a foreign facility, the name of and contact information for the facility's U.S. agent, including emergency contact information, unless the facility designates another emergency contact. A domestic facility must provide emergency contact information.
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.
If, for example, you do not have reasonable access to the Internet, you may submit a paper registration by mail or FAX.
You must register using Form 3537. Forms are available for download below. This PDF version of the form must be used for submission. Help for using PDF files and information on downloading free PDF readers is available at http://www.cfsan.fda.gov/~frf/help2.html.
You may also 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 800-216-7331 or 301-575-0156.
When you receive the form, you must fill it out completely and legibly and either mail it to U.S. Food and Drug Administration, HFS-681, 5600 Fishers Lane, Rockville, MD 20857, or FAX it to (301) 436-2804.
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. If you choose to register by paper, we recommend that you fill out the PDF using a computer and print it to minimize possible delays from illegibility. If you have the full version of Adobe Acrobat 6.0, you can save multiple filled-out copies to your computer for printing or submission on CD-ROM (see Registration by CD-ROM below). Forms are available for download below.
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.).
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.
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 the 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.).
If any information you previously submitted was incorrect at the time of submission, you must immediately update your facility's registration as specified in the Final Rule, §1.234.
Your facility is considered registered once FDA enters your facility's registration data into the registration system and the system generates a registration number.
FDA notes that CD-ROM submissions are similar to submissions sent by mail or FAX in terms of how they are processed. FDA will process these CD-ROM submissions along with the mailed and faxed submissions, in the order received. Therefore, registrants wanting to ensure that they receive their registration numbers quickly may wish to register electronically via the Internet. The principal advantage CD-ROMs offer over paper submissions is for firms that own many facilities and do not have reasonable access to the Internet. Using a CD-ROM to submit PDF typed registrations should increase legibility and save on mailing expenses. FDA reiterates, however, that submission by CD-ROM will be slower than submitting registrations electronically via the Internet.
Registrants submitting their registrations in CD-ROM format must use ISO 9660 (CD-R or CD-RW) data format.
You may also 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 800-216-7331 or 301-575-0156.
Each submission on the CD-ROM must use the same preferred mailing address in the appropriate block on Form 3537.
A CD-ROM may contain registrations for as many facilities as needed up to the CD-ROM's capacity.
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.
You must mail the CD-ROM to the U.S. Food and Drug Administration, HFS-681, 5600 Fishers Lane, Rockville, MD 20857.
If FDA receives a CD-ROM that does not comply with these specifications, it will return the CD-ROM to the submitter unprocessed.
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.
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.
If any information you previously submitted was incorrect at the time of submission, you must immediately update your facility's registration as specified in the Final Rule, §1.234.
Your facility is considered registered once FDA enters your facility's registration data into the registration system and the system generates a registration number.
Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, CFSAN is providing the following electronic forms for notifiers to submit their registrations. The PDF form may be filled out online and then printed, or printed and filled out by hand. The forms may also be downloaded to the user's computer for data entry. Note: You must have the full version of Adobe Acrobat 6.0 to save a filled-out form to your computer. The completed PDF form may be printed and mailed to the U.S. Food and Drug Administration, HFS-681, 5600 Fishers Lane, Rockville, MD 20857, or faxed to (301) 436-2804.
Instructions For Filling Out Paper Forms 3537 and 3537a (also available in PDF and Polish).
Food Facility Registration Form
DHHS/FDA Form No. 3537: (available in fill-in PDF for printing or CD-ROM).
Cancellation of Food Facility Registration Form
DHHS/FDA Form No. 3537a: (available in fill-in PDF for printing or CD-ROM).
Forms for Older Versions of Adobe Acrobat Reader (Version 3.0 and Higher)
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