
[Federal Register Volume 78, Number 65 (Thursday, April 4, 2013)]
[Notices]
[Pages 20326-20327]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-07809]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-0126]


Draft Compliance Policy Guide Sec. 100.250 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) is announcing the 
availability of draft Compliance Policy Guide Sec. 100.250 Food 
Facility Registration--Human and Animal Food (the draft CPG). The draft 
CPG, when finalized, will provide guidance for FDA staff on issues 
related to food facility registration under a section of the Federal 
Food, Drug, and Cosmetic Act (FD&C Act), 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.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comments on 
this draft CPG before it begins work on the final version of the CPG, 
submit either electronic or written comments on the draft CPG by May 6, 
2013.

ADDRESSES: Submit written requests for single copies of the draft CPG 
to the Division of Compliance Policy (HFC-230), Office of Enforcement, 
Food and Drug Administration, 12420 Parklawn Dr., Rockville, MD 20857. 
Send two self-

[[Page 20327]]

addressed adhesive labels to assist that office in processing your 
request, or fax your request to 240-632-6861. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the draft CPG.
    Submit electronic comments on the draft CPG to http://www.regulations.gov. Submit written comments 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, 240-276-9200.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft CPG entitled 
``Compliance Policy Guide Sec. 100.250 Food Facility Registration--
Human and Animal Food.'' The draft CPG is being issued consistent with 
FDA's good guidance practices regulation (21 CFR 10.115). The draft 
CPG, when finalized, will replace ``Compliance Policy Guide Sec. 
110.300 Registration of Food Facilities Under the Public Health 
Security and Bioterrorism Preparedness and Response Act of 2002.''
    Section 415 of the FD&C Act (21 U.S.C. 350d) requires owners, 
operators, or agents in charge of domestic and foreign facilities that 
manufacture, process, pack, or hold food for human or animal 
consumption in the United States to register their facilities with FDA, 
unless an exception applies (see 21 CFR 1.226 and 1.227). The FDA Food 
Safety Modernization Act (FSMA) (Pub. L. 111-353), enacted on January 
4, 2011, amended section 415 of the FD&C Act in relevant part to 
require registrants for food facilities to submit additional 
registration information to FDA, and to require facilities required to 
register with FDA to renew such registrations biennially. FSMA also 
amended section 415 of the FD&C Act to provide FDA with authority to 
suspend the registration of a food facility in certain circumstances. 
Specifically, if FDA determines that food manufactured, processed, 
packed, received, or held by a registered facility has a reasonable 
probability of causing serious adverse health consequences or death to 
humans or animals, FDA may by order suspend the registration of a 
facility that: (1) Created, caused, or was otherwise responsible for 
such reasonable probability; or (2) knew of, or had reason to know of, 
such reasonable probability; and packed, received, or held such food.
    The draft CPG is intended to provide guidance for FDA staff 
regarding enforcement of the food facility registration provisions of 
section 415 of the FD&C Act, 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 draft CPG also 
contains information that may be useful for the regulated industry and 
to the public.
    The draft CPG, when finalized, will represent the Agency's current 
thinking on food facility registration requirements of section 415 of 
the FD&C Act. 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 draft 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 21 CFR 1.230 
through 1.235 and section 415 of the FD&C Act have been approved under 
OMB Control No. 0910-0502.

III. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments 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.

IV. Electronic Access

    Persons with access to the Internet may obtain the draft CPG from 
FDA's Office of Regulatory Affairs history page. It may be accessed at 
http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/default.htm. Guidance documents are also 
available at http://www.regulations.gov.

    Dated: March 22, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-07809 Filed 4-3-13; 8:45 am]
BILLING CODE 4160-01-P


