
[Federal Register Volume 79, Number 106 (Tuesday, June 3, 2014)]
[Notices]
[Page 31949]
From the Federal Register Online via the Government Printing 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


