[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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