[Federal Register Volume 79, Number 106 (Tuesday, June 3, 2014)]
[Notices]
[Page 31949]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-12786]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-D-0126]
Compliance Policy Guide Regarding Food Facility Registration--
Human and Animal Food; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the
availability of Compliance Policy Guide Sec. 100.250 Food Facility
Registration--Human and Animal Food (the CPG). The CPG provides
guidance for our staff on enforcement of food facility registration
requirements.
DATES: Submit either electronic or written comments on FDA's CPGs at
any time.
ADDRESSES: Submit written requests for single copies of the CPG to the
Office of Policy and Risk Management, Office of Regulatory Affairs,
Office of Global Regulatory Operations and Policy, Food and Drug
Administration, 12420 Parklawn Dr., Rockville, MD 20857. Send two self-
addressed adhesive labels to assist that office in processing your
request. See the SUPPLEMENTARY INFORMATION section for electronic
access to the CPG.
Submit electronic comments on the CPG to http://www.regulations.gov. Submit written comments on the CPG to the Division
of Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Mischelle B. Ledet, Center for Food
Safety and Applied Nutrition (HFS-615), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740, 240-205-1165; or Kim
R. Young, Center for Veterinary Medicine (HFV-230), Food and Drug
Administration, 7519 Standish Pl., Rockville, MD 20855, 240-276-9207.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of Compliance Policy Guide Sec.
100.250 Food Facility Registration--Human and Animal Food. The CPG is
being issued consistent with FDA's good guidance practices regulation
(21 CFR 10.115). The CPG represents our current thinking on this topic.
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.
The CPG provides guidance for FDA staff regarding enforcement of
the food facility registration provisions of section 415 of the FD&C
Act (21 U.S.C. 350d), including the requirement that certain food
facilities register with FDA, the requirement that registered
facilities biennially renew their registrations with FDA, and FDA's
authority to suspend a food facility's registration. The CPG also
contains information that may be useful for the regulated industry and
to the public.
In the Federal Register of April 4, 2013 (78 FR 20326), we made
available draft CPG Sec. 100.250 Food Facility Registration--Human and
Animal Food and gave interested parties an opportunity to submit
comments by May 6, 2013, for us to consider before beginning work on
the final version of the CPG. We received two comments on the draft
CPG. We are issuing the CPG with no substantive changes, but made
editorial changes for clarity.
The CPG announced in this notice finalizes the draft CPG dated
April 2013. The CPG replaces CPG Sec. 110.300 Registration of Food
Facilities Under the Public Health Security and Bioterrorism
Preparedness and Response Act of 2002.
II. Comments
Interested persons may submit either electronic comments regarding
the CPG to http://www.regulations.gov or written comments regarding the
CPG to the Division of Dockets Management (see ADDRESSES). 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.
III. Electronic Access
Persons with access to the Internet may obtain the CPG at either
http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/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 CPG.
Dated: May 27, 2014.
Melinda K. Plaisier,
Associate Commissioner for Regulatory Affairs, Office of Regulatory
Affairs.
[FR Doc. 2014-12786 Filed 6-2-14; 8:45 am]
BILLING CODE 4160-01-P