[Federal Register Volume 78, Number 81 (Friday, April 26, 2013)]
[Proposed Rules]
[Pages 24691-24692]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-09763]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 1, 16, 106, 110, 114, 117, 120, 123, 129, 179, and 211

[Docket No. FDA-2011-N-0920]
RIN 0910-AG36


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; extension of comment periods.

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SUMMARY: The Food and Drug Administration (FDA or we) is extending the 
comment period for the proposed rule, and for the information 
collection related to the proposed rule, ``Current Good Manufacturing 
Practice and Hazard Analysis and Risk-Based Preventive Controls for 
Human Food'' that appeared in the Federal Register of January 16, 2013. 
We are taking this action in response to requests for an extension to 
allow interested persons additional time to submit comments on the 
proposed rule. 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: The comment period for the proposed rule published January 16, 
2013, at 78 FR 3646, is extended. In addition, the comment period for 
the information collection issues in the proposed rule, extended 
February 19, 2013, at 78 FR 11611, is further extended. Submit either 
electronic or written comments on the proposed rule by September 16, 
2013. Submit comments on information collection issues under the 
Paperwork Reduction Act of 1995 by September 16, 2013 (see the 
``Paperwork Reduction Act of 1995'' section of this document).

ADDRESSES: You may submit comments, identified by Docket No. FDA-2011-
N-0920 and/or Regulatory Information Number (RIN) 0910-AG36, by any of 
the following methods, except that comments on information collection 
issues under the Paperwork Reduction Act of 1995 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 or CD-ROM 
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 
and Docket No. 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 ``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: Jenny Scott, Center for Food 
Safety and Applied Nutrition (HFS-300), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-2166.
    With regard to the information collection: Domini Bean, Office of 
Information Management, Food and Drug Administration, 1350 Picard 
Drive, PI50-400T, Rockville, MD 20850, [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    In the Federal Register of January 16, 2013 (78 FR 3646), we 
published a proposed rule entitled ``Current Good Manufacturing 
Practice and Hazard Analysis and Risk-Based Preventive Controls for 
Human Food'' with a 120-day comment period on the provisions of the 
proposed rule and a 30-day comment period on the information collection 
provisions that are subject to review by OMB under the Paperwork 
Reduction Act of 1995 (44 U.S.C. 3501-3520).
    OMB and FDA previously received requests for a 90-day extension of 
the comment period for the information collection provisions of the 
proposed rule. We considered the requests and extended the comment 
period for the information collection for 90 days to make the comment 
period for the information collection provisions the same as that for 
the proposed rule--i.e., until May 16, 2013 (Federal Register of 
February 19, 2013, 78 FR 11611). FDA has now received comments 
requesting an extension of the comment period on the proposed rule. 
Each request conveyed concern that the current 120-day comment period 
does not allow sufficient time to develop a meaningful or thoughtful 
response to the proposed rule. FDA has considered the requests and is 
granting a 120-day extension of the comment period for the proposed 
rule. FDA believes that a 120-day extension allows adequate time for 
interested persons to submit comments without significantly delaying 
rulemaking on these important issues. We also are extending the comment 
period for the information collection provisions for 120 days to 
continue 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

[[Page 24692]]

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 Human Food.''

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: April 22, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-09763 Filed 4-24-13; 11:15 am]
BILLING CODE 4160-01-P