[Federal Register Volume 81, Number 248 (Tuesday, December 27, 2016)]
[Proposed Rules]
[Pages 95068-95069]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-31193]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1

[Docket No. FDA-2012-D-1002]


Questions and Answers Regarding Food Facility Registration 
(Seventh Edition); Revised Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of availability.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
availability of a revised draft guidance for industry entitled 
``Questions and Answers Regarding Food Facility Registration (Seventh 
Edition): Guidance for Industry.'' The revised draft guidance 
supersedes the version of the food facility registration draft guidance 
that we announced on November 8, 2016. When finalized, this guidance is 
intended to provide updated information relating to the food facility 
registration requirements in the Federal Food, Drug, and Cosmetic Act 
(the FD&C Act).

DATES: 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draft guidance before we begin work on the final version of the 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draft guidance by March 27, 2017.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2012-D-1002 for the revised draft guidance for industry entitled 
``Questions and Answers Regarding Food Facility Registration (Seventh 
Edition).'' Received comments will be placed in the docket and, except 
for those submitted as ``Confidential Submissions,'' publicly viewable 
at http://www.regulations.gov or at the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the draft guidance to 
the Office of Compliance, Division of Field Programs and Guidance, 
Center for Food Safety and Applied Nutrition, Food and Drug 
Administration, 5001 Campus Dr., College Park, MD 20740. Send two self-
addressed adhesive labels to assist that office in processing your 
request. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance.

FOR FURTHER INFORMATION CONTACT: Courtney Buchanan, Center for Food 
Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus 
Dr., College Park, MD 20740, 240-402-2487.

SUPPLEMENTARY INFORMATION: 

I. Background

    We are announcing the availability of a revised draft guidance for 
industry entitled ``Questions and Answers Regarding Food Facility 
Registration (Seventh Edition): Guidance for Industry.'' The revised 
draft guidance supersedes the version of the food facility registration 
draft guidance that we announced on November 8, 2016 (81 FR 78526). We 
are issuing the revised draft guidance consistent with our good 
guidance practices regulation (21 CFR

[[Page 95069]]

10.115). The revised draft guidance, when finalized, will represent the 
current thinking of FDA on this topic. It does not establish any rights 
for any person and is not binding on FDA or the public. You can use an 
alternate approach if it satisfies the requirements of the applicable 
statutes and regulations.
    On October 10, 2003, FDA issued an interim final rule (68 FR 58893) 
to implement amendments to the FD&C Act made by the Public Health 
Security and Bioterrorism Preparedness and Response Act of 2002 (Pub. 
L. 107-188). Section 415 of the FD&C Act (21 U.S.C. 350d) requires 
domestic and foreign facilities that manufacture, process, pack, or 
hold food for human or animal consumption in the United States to 
register with FDA by December 12, 2003. Section 102 of the FDA Food 
Safety Modernization Act (FSMA) (Pub. L. 111-353), enacted on January 
4, 2011, amended section 415 of the FD&C Act to, among other things, 
require facilities engaged in manufacturing, processing, packing, or 
holding food for consumption in the United States to submit additional 
registration information to FDA. Section 102 of FSMA also directed FDA 
to amend the definition of ``retail food establishment'' in 21 CFR 
1.227. On July 14, 2016, FDA issued a final rule (Registration Final 
Rule) to amend and update FDA's registration regulation and implement 
the FSMA revisions (81 FR 45912; July 14, 2016).
    This revised draft guidance was developed to answer frequently 
asked questions relating to the registration requirements of section 
415 of the FD&C Act. The first edition of the guidance was issued as 
Level 2 guidance consistent with our good guidance practices regulation 
(21 CFR 10.115) and was made available on FDA's Web site on December 4, 
2003. The second, third, fourth, and fifth editions of the guidance 
were issued as Level 1 guidance documents under 21 CFR 10.115 and were 
made available on FDA's Web site on January 12, 2004; February 17, 
2004; August 6, 2004; and December 17, 2012, respectively. The sixth 
edition of the guidance was issued as Level 1 guidance and included one 
additional question and answer relating to a proposed amendment to the 
``farm'' definition in 21 CFR 1.227 (see 79 FR 58523; September 29, 
2014). Since publication of the sixth edition of the guidance, we have 
issued the Registration Final Rule. In addition, we have issued the 
Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based 
Preventive Controls for Human Food final rule (80 FR 55908; September 
17, 2015) that, among other things, revised the definition of ``farm'' 
in 21 CFR 1.227. We have also issued the Current Good Manufacturing 
Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food 
for Animals final rule (80 FR 56169; September 17, 2015). We are 
issuing a seventh edition of the guidance to add information relating 
to the Registration Final Rule and the revised ``farm'' definition, as 
well as to address questions received from stakeholders since 
publication of the sixth edition.
    This edition of the guidance also revises information in existing 
questions and answers, removes some questions and answers, and makes 
editorial changes (e.g., we reorganized existing questions and answers) 
to improve clarity. For the revised questions and answers, we are not 
adding a date indicating when the questions and answers were revised. 
As in the previous editions, the following indicators are used to help 
users identify revisions: (1) The guidance is identified as a revision 
of a previously issued document; (2) the revision date appears on the 
cover of the guidance; (3) the edition number of the guidance is 
included in its title; and (4) questions and answers that have been 
added since the sixth edition are identified as such in the body of the 
guidance.
    On November 8, 2016, we announced the availability of a draft 
guidance entitled ``Questions and Answers Regarding Food Facility 
Registration (Seventh Edition): Guidance for Industry.'' The draft 
guidance contained 15 sections of a multi-section guidance intended to 
provide updated information relating to the food facility registration 
requirements of section 415 of the FD&C Act. We reserved two sections 
in the draft guidance and stated that we would issue a revised draft 
guidance at a later date that would include those reserved sections.
    This revised draft guidance supersedes the food facility 
registration draft guidance that we issued in November 2016. In the 
revised draft guidance, we are including the 15 sections that were 
announced in the Federal Register on November 8, 2016, as well as 
including the two sections we reserved, ``Who is Exempt from 
Registration?'' and ``Definitions,'' from the draft guidance. The 
revised draft guidance also includes an additional question and answer 
related to mobile facilities in the section entitled ``What Information 
is Required in the Registration?''
    We are inviting comments on the revised draft guidance as a whole. 
As FDA considers the development of the final guidance, we will review 
comments received on the revised draft guidance, as well as the 
comments received on the food facility registration draft guidance we 
announced on November 8, 2016.

II. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
at either http://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/default.htm or http://www.regulations.gov. Use 
the FDA Web site listed in the previous sentence to find the most 
current version of the guidance.

III. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in 21 CFR 1.230 through 1.235 and 21 CFR 
1.245 have been approved under OMB control number 0910-0502.

    Dated: December 21, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-31193 Filed 12-23-16; 8:45 am]
 BILLING CODE 4164-01-P