Draft Compliance Policy Guide Sec. 100.250 Food Facility Registration-Human and Animal Food; Availability, 20326-20327 [2013-07809]

Download as PDF 20326 Federal Register / Vol. 78, No. 65 / Thursday, April 4, 2013 / Notices COST OF REGISTRATION Through August 6, 2013 Affiliation Member ............................................................................................................................................................ Nonmember ..................................................................................................................................................... Government/Health Authority Member ............................................................................................................ Government/Health Authority Nonmember * ................................................................................................... Academic Member ........................................................................................................................................... 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Written requests are to be sent to Division of Freedom of Information (ELEM–1029), Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857. The PDA/ FDA Joint Regulatory Conference offers the unique opportunity for participants to join FDA representatives and industry experts in face-to-face dialogues. Each year, FDA speakers provide updates on current efforts affecting the development of global regulatory strategies, while industry professionals from some of today’s leading pharmaceutical companies present case studies on how they wreier-aviles on DSK5TPTVN1PROD with NOTICES SUPPLEMENTARY INFORMATION: VerDate Mar<15>2010 14:48 Apr 03, 2013 Jkt 229001 employ global strategies in their daily processes. Through a series of sessions and meetings, the conference will provide participants with the opportunity to hear directly from FDA experts and representatives of global regulatory authorities on best practices, including: • Regulatory Submission and Meetings. • Quality Risk Management Implementation. • Manufacturing in the Future. • Quality Systems. • Regulatory Considerations During Development. • Cell Therapy Innovations. • Life Cycle Management. • Process Validation. • Validation FDA Guidance. • Challenges of Contract Manufacturing Organizations. • Contract Agreements. • Drug Safety. • Emerging Active Pharmaceutical Ingredients (API) Regulations. • Investigations. • Emerging API Regulations. • User Fees. • Excipient Best Practices. • Good Manufacturing Practices Foreign Inspections Findings. • Regulatory Process to Approval (Inspectional Readiness). • Combination Products and Companion Diagnostics. To help ensure the quality of FDAregulated products, the workshop helps to achieve objectives set forth in section 406 of the FDA Modernization Act of 1997 (21 U.S.C. 393), which includes working closely with stakeholders and maximizing the availability and clarity of information to stakeholders and the public. The workshop also is consistent with the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104–121), as outreach activities by Government Agencies to small businesses. PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 Dated: April 1, 2013. Peter Lurie, Acting Associate Commissioner for Policy and Planning. [FR Doc. 2013–07854 Filed 4–3–13; 8:45 am] BILLING CODE 4160–01–P 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. 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. SUMMARY: 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 selfDATES: E:\FR\FM\04APN1.SGM 04APN1 Federal Register / Vol. 78, No. 65 / Thursday, April 4, 2013 / Notices 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 https://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: wreier-aviles on DSK5TPTVN1PROD with NOTICES 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 VerDate Mar<15>2010 14:48 Apr 03, 2013 Jkt 229001 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 https://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 https:// 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 https:// www.fda.gov/ICECI/ ComplianceManuals/ CompliancePolicyGuidanceManual/ default.htm. Guidance documents are PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 20327 also available at https:// 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0001] Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee; Amendment of Notice AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing an amendment to the notice of the joint meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee. This meeting was announced in the Federal Register of March 14, 2013 (78 FR 16271–16272). The amendment is being made to reflect a change in the Agenda portion of the document. There are no other changes. FOR FURTHER INFORMATION CONTACT: Kalyani Bhatt, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31 rm. 2417, Silver Spring, MD 20993–0002, 301– 796–9001, FAX: 301–847–8533, ACRHD@fda.hhs.gov, or use the FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington DC area), and follow the prompts to the desired center or product area. Please call the Information Line for up-to-date information on this meeting. SUPPLEMENTARY INFORMATION: In the Federal Register of March 14, 2013, FDA announced that a joint meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee would be held on April 18, 2013. On page 16272, in the first column, the Agenda portion of the document is changed to read as follows: Agenda: The committee will discuss the efficacy and safety of new drug application (NDA) 22219, AVEED (testosterone undecanoate) intramuscular injection, submitted by Endo Pharmaceutical Solutions, Inc., for the proposed indication of replacement E:\FR\FM\04APN1.SGM 04APN1

Agencies

[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]


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

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.

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

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 https://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 https://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 https://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 
https://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/default.htm. Guidance documents are also 
available at https://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
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