[Federal Register Volume 78, Number 33 (Tuesday, February 19, 2013)]
[Proposed Rules]
[Page 11611]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-03732]


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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 Period 
for Information Collection Provisions

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; extension of comment period for information 
collection provisions.

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SUMMARY: The Food and Drug Administration (FDA or ``we'') is extending 
the comment period for the information collection related to the 
proposed rule on ``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. In the preamble 
to the proposed rule, FDA requested comments on the information 
collection provisions that are subject to review by the Office of 
Management and Budget (OMB) under the Paperwork Reduction Act of 1995. 
We are taking this action in response to requests for an extension to 
allow interested persons additional time to submit comments on the 
information collection provisions associated with the rule.

DATES: The comment period for the proposed rule published January 16, 
2013 (78 FR 3646), is extended. Submit either electronic or written 
comments by May 16, 2013.

ADDRESSES: To ensure that comments on information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the title ``Current Good 
Manufacturing Practice and Hazard Analysis and Risk-Based Preventive 
Controls for Human Food.''

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Information 
Management, Food and Drug Administration, 1350 Picard 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'' 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). Comments on the provisions 
of the rule and on the information collection provisions will inform 
FDA's rulemaking to modernize the regulation for ``Current Good 
Manufacturing Practice In Manufacturing, Packing, or Holding Human 
Food'' and to add requirements for domestic and foreign facilities that 
are required to register under the Federal Food, Drug, and Cosmetic Act 
to establish and implement hazard analysis and risk-based preventive 
controls for human food.
    OMB and FDA have received two requests for a 90-day extension of 
the comment period for the information collection provisions of the 
proposed rule. The requests conveyed concern that the current 30-day 
comment period does not allow sufficient time to develop a meaningful 
or thoughtful response to the information collection provisions 
submitted to OMB under the Paperwork Reduction Act of 1995.
    We have considered the requests and are extending the comment 
period for the information collection for 90 days, until May 16, 2013. 
We believe that a 90-day extension allows adequate time for interested 
persons to submit comments without significantly delaying rulemaking on 
these important issues. A 90-day extension also will make the comment 
period for the information collection provisions the same as the 
comment period for the provisions of the proposed rule.

II. Request for Comments

    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.''

    Dated: February 13, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-03732 Filed 2-15-13; 8:45 am]
BILLING CODE 4160-01-P