[Federal Register Volume 78, Number 154 (Friday, August 9, 2013)]
[Proposed Rules]
[Pages 48636-48637]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-19300]


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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 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 to allow interested persons an 
opportunity to consider the interrelationships between this proposal 
and the two proposals announced in July 2013 on the Foreign Supplier 
Verification Program and on Accreditation of Third-Party Auditors/
Certification Bodies. 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 FDA is extending the comment period on the above proposed 
rule. Submit either electronic or written comments on the proposed rule 
by November 15, 2013. Submit comments on information collection issues 
under the Paperwork Reduction Act of 1995 (the PRA) by November 15, 
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 ``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: 
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 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 PRA (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 continued to receive comments 
requesting an extension of the comment period on the proposed rule. 
Each request conveyed concern that the 120-day comment period did not 
allow sufficient time to develop a meaningful or thoughtful response to 
the proposed rule. FDA considered the requests and granted a 120-day 
extension of the comment period for the proposed rule

[[Page 48637]]

and for the information collection provisions--i.e., until September 
16, 2013 (Federal Register of April 26, 2013, 78 FR 24691). In the 
Federal Register of July 29, 2013 (78 FR 45729 and 78 FR 45781) we 
published two proposed rules entitled, ``Foreign Supplier Verification 
Programs for Importers of Food for Humans and Animals'' (Docket No. 
FDA-2011-N-0143) and ``Accreditation of Third-Party Auditors/
Certification Bodies to Conduct Food Safety Audits and to Issue 
Certifications'' (Docket No. FDA-2011-N-0146) with a 120-day comment 
period. These two proposals are related to the proposed rule ``Current 
Good Manufacturing Practice and Hazard Analysis and Risk-Based 
Preventive Controls for Human Food.'' Therefore, FDA is granted a 60-
day final extension of the comment period for the ``Current Good 
Manufacturing Practice and Hazard Analysis and Risk-Based Preventive 
Controls for Human Food'' proposed rule to allow interested person an 
opportunity to consider the interrelationships between the proposals. 
We also are extending the comment period for the information collection 
provisions for 60 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 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: August 5, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-19300 Filed 8-8-13; 8:45 am]
BILLING CODE 4160-01-P