[Federal Register Volume 77, Number 242 (Monday, December 17, 2012)]
[Notices]
[Pages 74671-74672]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-30328]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Guidance for Industry: Questions and Answers Regarding Food 
Facility Registration (Fifth Edition)

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance for industry entitled ``Questions and 
Answers Regarding Food Facility Registration (Fifth Edition).'' The 
guidance provides updated information pertaining to registration of 
human and animal food facilities under the Federal Food, Drug, and 
Cosmetic Act (the FD&C Act), as amended by the FDA Food Safety 
Modernization Act (FSMA) on January 4, 2011.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments on the guidance to the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit written 
requests for single copies of the guidance to the Office of Compliance, 
Division of Field Programs and Guidance, Center for Food Safety and 
Applied Nutrition (HFS-615), Food and Drug Administration, 5100 Paint 
Branch Pkwy., 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 
guidance.

FOR FURTHER INFORMATION CONTACT: Amy Barringer, Center for Food Safety 
and Applied Nutrition (HFS-615), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740, 240-402-1988.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Questions and Answers Regarding Food Facility Registration 
(Fifth Edition),'' which replaces the fourth edition of a guidance 
entitled ``Questions and Answers Regarding Registration of Food 
Facilities (Edition 4)'' issued in August 2004. The guidance provides 
updated information pertaining to the registration of food facilities 
that manufacture, process, pack, or hold food for human or animal 
consumption in the United States.
    On October 10, 2003, FDA issued an interim final rule (68 FR 58894) 
to implement amendments to the FD&C Act made by the Public Health 
Security and Bioterrorism Preparedness and Response Act of 2002 (the 
Bioterrorism Act) (Public Law 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. This guidance 
was developed to answer frequently asked questions relating to the 
registration requirements of section 415.
    Section 102 of FSMA (Pub. L. 111-353), enacted on January 4, 2011, 
amended section 415 of the FD&C Act, in relevant part, to require 
facilities engaged in manufacturing, processing, packing, or holding 
food for consumption in the United States to submit additional 
registration information to FDA. This revised edition of the guidance 
includes new information relating to the FSMA amendments to section 
415.
    The first edition of this document was issued as level 2 guidance 
under Sec.  10.115 (21 CFR 10.115) and was made available on FDA's Web 
site on December 4, 2003. The second, third, and fourth editions of 
this document were issued as level 1 guidance documents under Sec.  
10.115 and were made available on FDA's Web site on January 12, 2004, 
February 17, 2004, and August 2004, respectively. This revision (fifth 
edition) is being issued as a level 1 guidance and includes questions 
and answers relating to the FSMA amendments to section 415 of the FD&C 
Act. In addition, the guidance provides non-substantive revisions to 
clarify, delete, and renumber the questions and answers in edition 4.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation Sec.  10.115 as a level 1 guidance. The Agency 
will accept comments at any time, but it is implementing this guidance 
immediately, in accordance with Sec.  10.115(g)(2) because the Agency 
has determined that prior public participation is not feasible or 
appropriate.

[[Page 74672]]

    The guidance represents the Agency's current thinking on food 
facility registration. It does not create or confer any rights for or 
on any person and does not operate to bind FDA or the public. An 
alternate approach may be used if such approach satisfies the 
requirements of the applicable statutes and regulations.

II. 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 guidance at 
either http://www.fda.gov/FoodGuidances or http://www.regulations.gov. 
Always access an FDA document using the FDA 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. 2012-30328 Filed 12-14-12; 8:45 am]
BILLING CODE 4160-01-P