[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