Compliance Policy Guide Regarding Food Facility Registration-Human and Animal Food; Availability, 31949 [2014-12786]

Download as PDF Federal Register / Vol. 79, No. 106 / Tuesday, June 3, 2014 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Food and Drug Administration [Docket No. FDA–2013–D–0126] [Docket No. FDA–2013–N–0973] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Pet Event Tracking Network—State, Federal Cooperation To Prevent Spread of Pet Food Related Diseases AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Pet Event Tracking Network (PETNet)—State, Federal Cooperation to Prevent Spread of Pet Food Related Diseases’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. SUMMARY: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE–14526, Silver Spring, MD 20993–0002, PRAStaff@ fda.hhs.gov. FOR FURTHER INFORMATION CONTACT: On March 3, 2014, the Agency submitted a proposed collection of information entitled ‘‘Pet Event Tracking Network (PETNet)—State, Federal Cooperation to Prevent Spread of Pet Food Related Diseases’’ to OMB for review and clearance under 44 U.S.C. 3507. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910–0680. The approval expires on May 31, 2017. A copy of the supporting statement for this information collection is available on the Internet at https://www.reginfo.gov/ public/do/PRAMain. sroberts on DSK4SPTVN1PROD with NOTICES SUPPLEMENTARY INFORMATION: Dated: May 27, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–12813 Filed 6–2–14; 8:45 am] BILLING CODE 4160–01–P VerDate Mar<15>2010 17:35 Jun 02, 2014 Jkt 232001 Compliance Policy Guide Regarding Food Facility Registration—Human and Animal Food; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. 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 https://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: SUMMARY: 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. PO 00000 Frm 00034 Fmt 4703 Sfmt 9990 31949 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 https://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 https:// www.regulations.gov. III. Electronic Access Persons with access to the Internet may obtain the CPG at either https:// www.fda.gov/ICECI/Compliance Manuals/CompliancePolicyGuidance Manual/default.htm or https://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 E:\FR\FM\03JNN1.SGM 03JNN1

Agencies

[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.

-----------------------------------------------------------------------

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 https://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 https://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 https://www.regulations.gov.

III. Electronic Access

Persons with access to the Internet may obtain the CPG at either
https://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/default.htm or https://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

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