
[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


