[Federal Register Volume 79, Number 22 (Monday, February 3, 2014)]
[Proposed Rules]
[Pages 6111-6112]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-02111]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 16, 225, 500, 507, and 579

[Docket No. FDA-2011-N-0922]
RIN 0910-AG10


Current Good Manufacturing Practice and Hazard Analysis and Risk-
Based Preventive Controls for Food for Animals; Extension of Comment 
Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; extension of comment period.

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SUMMARY: The Food and Drug Administration (FDA or we) is extending the 
comment period for the notice of proposed rulemaking that appeared in 
the Federal Register of October 29, 2013 (78 FR 64736), entitled 
``Current Good Manufacturing Practice and Hazard Analysis and Risk-
Based Preventive Controls for Food for Animals '' and its information 
collection

[[Page 6112]]

provisions. We are taking this action in response to requests for an 
extension to allow interested persons more time to comment given that 
in addition to the proposed preventive control requirements, the 
proposed current good manufacturing practice (CGMP) requirements are 
also new to the animal food industry, unlike the human food industry.
    We also are taking this action to keep the comment period for the 
information collection provisions associated with the rule consistent 
with the comment period for the proposed rule.

DATES: FDA is extending the comment period on the proposed rule and its 
information collection provisions. Submit either electronic or written 
comments on the proposed rule and the information collection by March 
31, 2014.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2011-
N-0922 and/or Regulatory Information Number (RIN) 0910-AG10, by any of 
the following methods, except that comments on information collection 
issues under the PRA must be submitted to the Office of Information and 
Regulatory Affairs, Office of Management and Budget (OMB) (see the 
``Paperwork Reduction Act of 1995'' section of this document).

Electronic Submissions

    Submit electronic comments in the following way:
    Federal eRulemaking Portal: http://www.regulations.gov. Follow the 
instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
    Mail/Hand delivery/Courier (for paper submissions): Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency 
name, Docket No. FDA-2011-N-0922, and RIN 0910-AG10 for this 
rulemaking. All comments received may be posted without change to 
http://www.regulations.gov, including any personal information 
provided. For additional information on submitting comments, see the 
``Request for Comments'' heading of the SUPPLEMENTARY INFORMATION 
section of this document.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.regulations.gov, and insert the 
docket number, found in brackets in the heading of this document, into 
the ``Search'' box and follow the prompts and/or go to the Division of 
Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: With regard to the proposed rule: Kim 
Young, Center for Veterinary Medicine, Food and Drug Administration, 
7519 Standish Pl., Rockville, MD 20855, 240-276-2207.
    With regard to the information collection: Domini Bean, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400T, Rockville, MD 20850, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of October 29, 2013, we published a 
proposed rule entitled ``Current Good Manufacturing Practice and Hazard 
Analysis and Risk-Based Preventive Controls for Food for Animals'' with 
a 120-day comment period on the provisions of the proposed rule and on 
the information collection provisions that are subject to review by OMB 
under the PRA (44 U.S.C. 3501-3520).
    FDA has received requests for an extension of the comment period on 
the proposed rule. The requests conveyed concern that the current 120-
day comment period does not allow time to develop a meaningful response 
to the proposed rule because, unlike the human food industry, in 
addition to the proposed preventive controls, the proposed CGMPs are 
new to the animal food industry. The requests also stated an extended 
comment period would allow interested persons an opportunity to 
consider the interrelationship between this proposed rule and the 
proposed rules entitled ``Foreign Supplier Verification Programs for 
Importers of Food for Humans and Animals'' (78 FR 45729, July 29, 2013) 
and ``Accreditation of Third-Party Auditors/Certification Bodies to 
Conduct Food Safety Audits and to Issue Certifications'' (78 FR 45782, 
July 29, 2013). FDA has considered the requests and is granting an 
extension of the comment period to March 31, 2014, for the ``Current 
Good Manufacturing Practice and Hazard Analysis and Risk-Based 
Preventive Controls for Food for Animals'' proposed rule to allow 
interested persons additional time to submit comments. We also are 
extending the comment period for the information collection provisions 
to March 31, 2014, to make the comment period for the information 
collection provisions the same as the comment period for the provisions 
of the proposed rule. To clarify, FDA is requesting comment on all 
issues raised by the proposed rule.

II. Paperwork Reduction Act of 1995

    Interested persons may either submit electronic comments regarding 
the information collection to [email protected] or fax 
written comments to the Office of Information and Regulatory Affairs, 
OMB, Attn: FDA Desk Officer, FAX: 202-395-7285. All comments should be 
identified with the title ``Current Good Manufacturing Practice and 
Hazard Analysis and Risk-Based Preventive Controls for Food for 
Animals.''

III. Request for Comments

    Interested persons may submit either electronic comments regarding 
the proposed rule 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.

    Dated: January 28, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-02111 Filed 1-31-14; 8:45 am]
BILLING CODE 4160-01-P