[Federal Register Volume 77, Number 242 (Monday, December 17, 2012)]
[Rules and Regulations]
[Pages 74582-74583]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-30327]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 1
[Docket No FDA-2012-D-1003]
Small Entity Compliance Guide: What You Need To Know About
Registration of Food Facilities; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of an updated guidance for industry entitled ``What You
Need To Know About Registration of Food Facilities--Small Entity
Compliance Guide.'' FDA has prepared this guidance to restate the legal
requirements pertaining to registration of food facilities in the
Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the
FDA Food Safety Modernization Act (FSMA). Previously, this guidance
restated the legal requirements of FDA's food facility registration
regulation. This document also served as FDA's Small Entity Compliance
Guide for FDA's food facility registration regulation in accordance
with the Small Business Regulatory Enforcement Fairness Act. FDA is
revising this document to provide guidance intended to help any entity
comply with the requirements pertaining to registration of food
[[Page 74583]]
facilities in the FD&C Act, including the amendments made by FSMA. This
document continues to serve as FDA's Small Entity Compliance Guide for
FDA's food facility registration regulation. Further, this guidance is
intended to set forth in plain language the requirements for
registration of food facilities and help small businesses understand
the requirements.
DATES: December 17, 2012. Submit either electronic or written comments
on Agency guidances at any time.
ADDRESSES: Submit written requests for single copies of this guidance
to the Office of Compliance, Division of Field Programs and Guidance
(HFS-615), Center for Food Safety and Applied Nutrition, Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. Send
one self-addressed adhesive label to assist that office in processing
your request. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance.
Submit electronic comments on this guidance to http://www.regulations.gov. Submit written comments on this guidance to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Amy Barringer, Office of Compliance,
Center for Food Safety and Applied Nutrition, Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-
402-1988.
SUPPLEMENTARY INFORMATION:
I. Background
The FDA Food Safety Modernization Act (FSMA), enacted on January 4,
2011, amended section 415 of the FD&C Act, in relevant part, to require
that facilities engaged in manufacturing, processing, packing, or
holding food for consumption in the United States submit additional
registration information to FDA, including an assurance that FDA will
be permitted to inspect the facility at the times and in the manner
permitted by the FD&C Act. Section 415 of the FD&C Act, as amended by
FSMA, also requires food facilities required to register with FDA to
renew such registrations every other year and provides FDA with
authority to suspend the registration of a food facility in certain
circumstances.
FDA has prepared this guidance to restate the legal requirements in
section 415 of the FD&C Act. Previously, this guidance restated the
legal requirements of FDA's food facility registration regulation at 21
CFR part 1, Subpart H (Sec. Sec. 1.225 through 1.243), implementing
section 415 of the FD&C Act, as added by the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002. This guidance also
served as FDA's Small Entity Compliance Guide for 21 CFR part 1,
Subpart H in accordance with section 212 of the Small Business
Regulatory Enforcement Fairness Act (Pub. L. 104-121). Because section
415 of the FD&C Act was amended by section 102 of FSMA in 2011, FDA is
revising this document to provide guidance on section 415 of the FD&C
Act, as amended by FSMA. This updated guidance is intended to help any
entity comply with the requirements of section 415 of the FD&C Act,
including the amendments made by section 102 of FSMA. This document
continues to serve as FDA's Small Entity Compliance Guide for 21 CFR
Part 1, Subpart H.
FDA is issuing this guidance consistent with FDA's good guidance
practices regulation (21 CFR 10.115) as level 1 guidance. Consistent
with FDA's good guidance practices regulation, the Agency will accept
comments, but it is implementing this guidance document immediately, in
accordance with 21 CFR 10.115(g)(2), because the Agency has determined
that prior public participation is not feasible or appropriate because
the updated guidance document is merely specifying the new requirements
of section 102 of FSMA, many of which are already in effect. This
guidance represents the Agency's current thinking on the registration
of food facilities. It does not create or confer any rights for or on
any person and does not operate to bind FDA or the public. An
alternative approach may be used if such approach satisfies the
requirements of the applicable statutes and regulations.
II. The Paperwork Reduction Act of 1995
This guidance refers to previously approved collections of
information found in FDA regulations and section 415 of the FD&C Act.
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 Sec. Sec.
1.230 through 1.235 and section 415 of the FD&C Act have been approved
under OMB control number 0910-0502.
III. Comments
Interested persons may submit either written comments regarding
this document to the Division of Dockets Management (see ADDRESSES) or
electronic comments to http://www.regulations.gov. It is only necessary
to send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.
IV. Electronic Access
Persons with access to the Internet may obtain the document at
either http://www.fda.gov/RegulatoryInformation/Guidances/default.htm
or http://www.regulations.gov. Always access an FDA guidance document
by using FDA's Web site listed previously to find the most current
version of the guidance.
Dated: December 12, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-30327 Filed 12-14-12; 8:45 am]
BILLING CODE 4160-01-P