[Federal Register Volume 78, Number 224 (Wednesday, November 20, 2013)]
[Proposed Rules]
[Pages 69604-69605]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-27783]


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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 period for the proposed 
rule and for its information collection provisions.

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SUMMARY: The Food and Drug Administration (FDA) is extending the 
comment period for the notice of proposed rulemaking that appeared in 
the Federal Register of January 16, 2013 (78 FR 3646), entitled 
``Current Good Manufacturing Practice and Hazard Analysis and Risk-
Based Preventive Controls for Human Food'' and its information 
collection provisions.

DATES: The FDA is extending the comment period for the proposed rule 
referenced in the Summary. Submit either electronic or written comments 
on the notice of proposed rulemaking by November 22, 2013. Submit 
comments on information collection issues under the Paperwork Reduction 
Act of 1995 (the PRA) by November 22, 2013 (see the ``Paperwork 
Reduction Act of 1995'' section).

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 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).

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. FDA-2011-N-0920, and RIN 0910-AG36 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 ``How to Submit 
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 Piccard Dr., PI50-400T, Rockville, MD 20850, 
domini.bean@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    In the Federal Register of January 16, 2013 (78 FR 3646), FDA 
published a proposed rule entitled ``Current Good Manufacturing 
Practice and Hazard Analysis and Risk-Based Preventive Controls for 
Human Food.'' The original comment period of 120 days was extended 
several times and interested persons were most recently given until 
November 15, 2013 (Federal Register of August 9, 2013, 78 FR 48636), to

[[Page 69605]]

comment on the proposed rule and its information collection provisions.

II. Request for Comments

    FDA is extending the comment period due to the inability of some 
commenters to submit comments through the http://www.regulations.gov 
Web site from November 4, 2013, through November 14, 2013, because of 
technical difficulties at that Web site.

III. Paperwork Reduction Act of 1995

    Interested persons may either submit electronic comments regarding 
the information collection to oira_submission@omb.eop.gov 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.''

IV. How To Submit 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.

    Dated: November 15, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-27783 Filed 11-15-13; 4:15 pm]
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