This document is scheduled to be published in the
Federal Register on 11/20/2013 and available online at 
http://federalregister.gov/a/2013-27783
, 
and on 
FDsys.gov
 
4160-01-P 
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 An alysis and Risk-Based Preventive Controls 
for Human Food; Extensi on of Comment Periods 
AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule; extension of commen t period for the proposed rule and for its 
information collection provisions. 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 Pr actice and Hazard Analysis and Risk-Based 
Preventive Controls for Human Food" a nd its information collection provisions. 
DATES:  The FDA is extending the comment peri od for the proposed rule referenced in the 
Summary.  Submit either electronic or writte n comments on the notice of proposed rulemaking 
by November 22, 2013. Submit comments on informa tion 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, iden tified by Docket No. FDA-2011-N-0920 and/or 
Regulatory Information Number (RIN) 0910-AG 36, by any of the following methods, except 
that comments on information collection issues under the PRA must be submitted to the Office  2
of Information and Regulatory Affairs, Offi ce 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 Admi nistration, 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 ru lemaking. 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 backgr ound 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 fo llow the prompts and/or go to the Division of 
Dockets Management, 5630 Fishers La ne, rm. 1061, Rockville, MD 20852. 
FOR FURTHER INFORMATION CONTACT: With regard to the proposed rule : Jenny Scott, 
Center for Food Safety and Applied Nutrit ion (HFS-300), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740, 240- 402-2166. With regard to the information  3
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 H azard Analysis and Risk-Based 
Preventive Controls for Human Food."  The original comment period of 120 days was extended 
several times and interested persons were mo st recently given until November 15, 2013 (Federal 
Register  of August 9, 2013, 78 FR 48636), to comment on the proposed rule and its information 
collection provisions. 
II. Request for Comments 
FDA is extending the comment period due to th e inability of some commenters to submit 
comments through the http://www.regulations.go v 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 elec tronic 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 "C urrent Good Manufacturi ng Practice and Hazard 
Analysis and Risk-Based Preventi ve Controls for Human Food." 
IV. How to Submit Comments 
Interested persons may submit either electr onic comments regarding this document to 
http://www.regulations.gov  or written comments to the Division of Dockets Management (see  4
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 Manageme nt between 9 a.m. and 4 p.m., Monday through 
Friday, and will be posted to the docket at http://www.regulations.gov .  5
 
Dated:  November 15, 2013 . 
Leslie Kux, Assistant Commissioner for Policy.    [FR Doc. 2013-27783 Filed 11/15/2013 at 4:15 pm; Publication Date: 11/20/2013]