81 FR 95068 - Questions and Answers Regarding Food Facility Registration (Seventh Edition); Revised Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 248 (December 27, 2016)

Page Range		95068-95069
FR Document		2016-31193

The Food and Drug Administration (FDA or we) is announcing the availability of a revised draft guidance for industry entitled ``Questions and Answers Regarding Food Facility Registration (Seventh Edition): Guidance for Industry.'' The revised draft guidance supersedes the version of the food facility registration draft guidance that we announced on November 8, 2016.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).

Federal Register, Volume 81 Issue 248 (Tuesday, December 27, 2016)

[Federal Register Volume 81, Number 248 (Tuesday, December 27, 2016)]
[Proposed Rules]
[Pages 95068-95069]
From the Federal Register Online [www.thefederalregister.org]
[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(Seventh Edition); Revised Draft Guidance for Industry; Availability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availability of a revised draft guidance for industry entitled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 The revised draft guidance
supersedes the version of the food facility registration draft guidance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draft guidance before we begin work on the final version of the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draft guidance by March 27, 2017.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

Federal Register / Vol. 81, No. 248 / Tuesday, December 27, 2016 / Proposed Rules 95069

10.115). The revised draft guidance, FR 55908; September 17, 2015) that, FDA considers the development of the
when finalized, will represent the among other things, revised the final guidance, we will review
current thinking of FDA on this topic. definition of ‘‘farm’’ in 21 CFR 1.227. comments received on the revised draft
It does not establish any rights for any We have also issued the Current Good guidance, as well as the comments
person and is not binding on FDA or the Manufacturing Practice, Hazard received on the food facility registration
public. You can use an alternate Analysis, and Risk-Based Preventive draft guidance we announced on
approach if it satisfies the requirements Controls for Food for Animals final rule November 8, 2016.
of the applicable statutes and (80 FR 56169; September 17, 2015). We
regulations. are issuing a seventh edition of the II. Electronic Access
On October 10, 2003, FDA issued an guidance to add information relating to Persons with access to the Internet
interim final rule (68 FR 58893) to the Registration Final Rule and the may obtain the draft guidance at either
implement amendments to the FD&C revised ‘‘farm’’ definition, as well as to http://www.fda.gov/Food/
Act made by the Public Health Security address questions received from GuidanceRegulation/
and Bioterrorism Preparedness and stakeholders since publication of the FoodFacilityRegistration/default.htm or
Response Act of 2002 (Pub. L. 107–188). sixth edition. http://www.regulations.gov. Use the
Section 415 of the FD&C Act (21 U.S.C. This edition of the guidance also FDA Web site listed in the previous
350d) requires domestic and foreign revises information in existing questions sentence to find the most current
facilities that manufacture, process, and answers, removes some questions version of the guidance.
pack, or hold food for human or animal and answers, and makes editorial
consumption in the United States to changes (e.g., we reorganized existing III. Paperwork Reduction Act of 1995
register with FDA by December 12, questions and answers) to improve This draft guidance refers to
2003. Section 102 of the FDA Food clarity. For the revised questions and previously approved collections of
Safety Modernization Act (FSMA) (Pub. answers, we are not adding a date information found in FDA regulations.
L. 111–353), enacted on January 4, 2011, indicating when the questions and These collections of information are
amended section 415 of the FD&C Act answers were revised. As in the subject to review by the Office of
to, among other things, require facilities previous editions, the following Management and Budget (OMB) under
engaged in manufacturing, processing, indicators are used to help users the Paperwork Reduction Act of 1995
packing, or holding food for identify revisions: (1) The guidance is (44 U.S.C. 3501–3520). The collections
consumption in the United States to identified as a revision of a previously of information in 21 CFR 1.230 through
submit additional registration issued document; (2) the revision date 1.235 and 21 CFR 1.245 have been
information to FDA. Section 102 of appears on the cover of the guidance; (3) approved under OMB control number
FSMA also directed FDA to amend the the edition number of the guidance is 0910–0502.
definition of ‘‘retail food establishment’’ included in its title; and (4) questions Dated: December 21, 2016.
in 21 CFR 1.227. On July 14, 2016, FDA and answers that have been added since
Leslie Kux,
issued a final rule (Registration Final the sixth edition are identified as such
Rule) to amend and update FDA’s in the body of the guidance. Associate Commissioner for Policy.
registration regulation and implement On November 8, 2016, we announced [FR Doc. 2016–31193 Filed 12–23–16; 8:45 am]
the FSMA revisions (81 FR 45912; July the availability of a draft guidance BILLING CODE 4164–01–P
14, 2016). entitled ‘‘Questions and Answers
This revised draft guidance was Regarding Food Facility Registration
developed to answer frequently asked (Seventh Edition): Guidance for POSTAL REGULATORY COMMISSION
questions relating to the registration Industry.’’ The draft guidance contained
requirements of section 415 of the FD&C 15 sections of a multi-section guidance 39 CFR Part 3004
Act. The first edition of the guidance intended to provide updated [Docket No. RM2017–2; Order No. 3671]
was issued as Level 2 guidance information relating to the food facility
consistent with our good guidance registration requirements of section 415 Changes to Procedures for the
practices regulation (21 CFR 10.115) and of the FD&C Act. We reserved two Freedom of Information Act
was made available on FDA’s Web site sections in the draft guidance and stated
on December 4, 2003. The second, third, that we would issue a revised draft AGENCY: Postal Regulatory Commission.
fourth, and fifth editions of the guidance guidance at a later date that would ACTION: Notice of proposed rulemaking.
were issued as Level 1 guidance include those reserved sections.
documents under 21 CFR 10.115 and This revised draft guidance SUMMARY: The Commission is initiating
were made available on FDA’s Web site supersedes the food facility registration a proceeding to revise its rules
on January 12, 2004; February 17, 2004; draft guidance that we issued in governing requests for agency records
August 6, 2004; and December 17, 2012, November 2016. In the revised draft made under the Freedom of Information
respectively. The sixth edition of the guidance, we are including the 15 Act (FOIA), in accordance in with the
guidance was issued as Level 1 sections that were announced in the FOIA Improvement Act of 2016, Public
guidance and included one additional Federal Register on November 8, 2016, Law 114–185, 130 Stat. 538. This notice
question and answer relating to a as well as including the two sections we informs the public of the filing, invites
proposed amendment to the ‘‘farm’’ reserved, ‘‘Who is Exempt from public comment, and takes other
definition in 21 CFR 1.227 (see 79 FR Registration?’’ and ‘‘Definitions,’’ from administrative steps.
mstockstill on DSK3G9T082PROD with PROPOSALS

58523; September 29, 2014). Since the draft guidance. The revised draft DATES: Comments are due on or before
publication of the sixth edition of the guidance also includes an additional January 26, 2017.
guidance, we have issued the question and answer related to mobile ADDRESSES: Submit comments
Registration Final Rule. In addition, we facilities in the section entitled ‘‘What electronically via the Commission’s
have issued the Current Good Information is Required in the Filing Online system at http://
Manufacturing Practice, Hazard Registration?’’ www.prc.gov. Those who cannot submit
Analysis, and Risk-Based Preventive We are inviting comments on the comments electronically should contact
Controls for Human Food final rule (80 revised draft guidance as a whole. As the person identified in the FOR FURTHER

VerDate Sep<11>2014 20:09 Dec 23, 2016 Jkt 241001 PO 00000 Frm 00004 Fmt 4702 Sfmt 4702 E:\FR\FM\27DEP1.SGM 27DEP1

Document Created: 2018-02-14 09:14:07
Document Modified: 2018-02-14 09:14:07

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Proposed Rules
Action		Notification of availability.
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.
Contact		Courtney Buchanan, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2487.
FR Citation		81 FR 95068

81 FR 95068 - Questions and Answers Regarding Food Facility Registration (Seventh Edition); Revised Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 248 (December 27, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration