Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food; Extension of Comment Periods, 24691-24692 [2013-09763]

Download as PDF Federal Register / Vol. 78, No. 81 / Friday, April 26, 2013 / Proposed Rules (h) Related Information Refer to Federal Office of Civil Aviation (FOCA) AD HB–2013–003, dated March 19, 2013; PILATUS PC–7 Maintenance Manual, Time Limited Inspection Requirements, 50– 10–20, pages 1 through 6, dated November 30, 2012; and PILATUS PC–7 Maintenance Manual, Emergency Fuel Control System— Adjustment/Test, 76–20–00, pages 501 and 502, dated November 30, 2010, for related information. For service information related to this AD, contact PILATUS AIRCRAFT LTD., Customer Technical Support (MCC), P.O. Box 992, CH–6371 STANS, Switzerland; telephone: +41 (0)41 619 67 74; fax: +41 (0)41 619 67 73; Internet: http://www.pilatusaircraft.com or email: Techsupport@pilatusaircraft.com. You may review copies of the referenced service information at the FAA, Small Airplane Directorate, 901 Locust, Kansas City, Missouri 64106. For information on the availability of this material at the FAA, call (816) 329–4148. Issued in Kansas City, Missouri, on April 19, 2013. Earl Lawrence, Manager, Small Airplane Directorate, Aircraft Certification Service. [FR Doc. 2013–09888 Filed 4–25–13; 8:45 am] BILLING CODE 4910–13–P DEPARTMENT OF HEALTH AND HUMAN SERVICES the comment period for the proposed rule. The comment period for the proposed rule published January 16, 2013, at 78 FR 3646, is extended. In addition, the comment period for the information collection issues in the proposed rule, extended February 19, 2013, at 78 FR 11611, is further extended. Submit either electronic or written comments on the proposed rule by September 16, 2013. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by September 16, 2013 (see the ‘‘Paperwork Reduction Act of 1995’’ section of this document). 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 Paperwork Reduction Act of 1995 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 of this document). DATES: Electronic Submissions 21 CFR Parts 1, 16, 106, 110, 114, 117, 120, 123, 129, 179, and 211 Submit electronic comments in the following way • Federal eRulemaking Portal: http:// www.regulations.gov. Follow the instructions for submitting comments. [Docket No. FDA–2011–N–0920] Written Submissions Food and Drug Administration 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. Proposed rule; extension of comment periods. ACTION: 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 in response to requests for an extension to allow interested persons additional time to submit comments on the proposed rule. We also are taking this action to keep the comment period for the information collection provisions associated with the rule consistent with erowe on DSK2VPTVN1PROD with PROPOSALS-1 SUMMARY: VerDate Mar<15>2010 17:19 Apr 25, 2013 Jkt 229001 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. 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 ‘‘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. PO 00000 Frm 00003 Fmt 4702 Sfmt 4702 24691 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 Picard Drive, 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), we published a proposed rule entitled ‘‘Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food’’ with a 120day 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). 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 has now received comments requesting an extension of the comment period on the proposed rule. Each request conveyed concern that the current 120day comment period does not allow sufficient time to develop a meaningful or thoughtful response to the proposed rule. FDA has considered the requests and is granting a 120-day extension of the comment period for the proposed rule. FDA believes that a 120-day extension allows adequate time for interested persons to submit comments without significantly delaying rulemaking on these important issues. We also are extending the comment period for the information collection provisions for 120 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 E:\FR\FM\26APP1.SGM 26APP1 24692 Federal Register / Vol. 78, No. 81 / Friday, April 26, 2013 / Proposed Rules 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.’’ 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: April 22, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–09763 Filed 4–24–13; 11:15 am] BILLING CODE 4160–01–P information collection provisions associated with the rule consistent with the comment period for the proposed rule. The comment period for the proposed rule published January 16, 2013, at 78 FR 3504, is extended. In addition, the comment period for the information collection issues in the proposed rule, extended February 19, 2013, at 78 FR 11611, is further extended. Submit either electronic or written comments on the proposed rule by September 16, 2013. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by September 16, 2013 (see the ‘‘Paperwork Reduction Act of 1995’’ section of this document). ADDRESSES: You may submit comments, identified by Docket No. FDA–2011–N– 0921 and/or Regulatory Information Number (RIN) 0910–AG35, by any of the following methods, except that comments on information collection issues under the Paperwork Reduction Act of 1995 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 of this document). DATES: Electronic Submissions DEPARTMENT OF HEALTH AND HUMAN SERVICES Submit electronic comments in the following way: • Federal eRulemaking Portal: http:// www.regulations.gov. Follow the instructions for submitting comments. Food and Drug Administration 21 CFR Parts 16 and 112 Written Submissions [Docket No. FDA–2011–N–0921] RIN 0910–AG35 Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption; Extension of Comment Periods AGENCY: Food and Drug Administration, HHS. Proposed rule; extension of comment periods. ACTION: 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, ‘‘Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption’’ that appeared in the Federal Register of January 16, 2013. We are taking this action in response to requests for an extension to allow interested persons additional time to submit comments on the proposed rule. We also are taking this action to keep the comment period for the erowe on DSK2VPTVN1PROD with PROPOSALS-1 SUMMARY: VerDate Mar<15>2010 14:46 Apr 25, 2013 Jkt 229001 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–0921, and RIN 0910–AG35 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 ‘‘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 PO 00000 Frm 00004 Fmt 4702 Sfmt 4702 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: Samir Assar, Center for Food Safety and Applied Nutrition (HFS–317), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240– 402–1636. With regard to the information collection: Domini Bean, Office of Information Management, Food and Drug Administration, 1350 Picard Drive, PI50–400T, Rockville, MD 20850, Domini.Bean@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of January 16, 2013 (78 FR 3504), we published a proposed rule entitled ‘‘Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption’’ 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). 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 has now received comments requesting an extension of the comment period on the proposed rule. Each request conveyed concern that the current 120day comment period does not allow sufficient time to develop a meaningful or thoughtful response to the proposed rule. FDA has considered the requests and is granting a 120-day extension of the comment period for the proposed rule. FDA believes that a 120-day extension allows adequate time for interested persons to submit comments without significantly delaying rulemaking on these important issues. We also are extending the comment period for the information collection provisions for 120 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. E:\FR\FM\26APP1.SGM 26APP1

Agencies

[Federal Register Volume 78, Number 81 (Friday, April 26, 2013)]
[Proposed Rules]
[Pages 24691-24692]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-09763]


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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 periods.

-----------------------------------------------------------------------

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 in response to requests for an extension to 
allow interested persons additional time to submit comments on the 
proposed rule. 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 comment period for the proposed rule published January 16, 
2013, at 78 FR 3646, is extended. In addition, the comment period for 
the information collection issues in the proposed rule, extended 
February 19, 2013, at 78 FR 11611, is further extended. Submit either 
electronic or written comments on the proposed rule by September 16, 
2013. Submit comments on information collection issues under the 
Paperwork Reduction Act of 1995 by September 16, 2013 (see the 
``Paperwork Reduction Act of 1995'' section of this document).

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 Paperwork Reduction Act of 1995 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 
of this document).

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. 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 ``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 Picard 
Drive, 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), 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 Paperwork 
Reduction Act of 1995 (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 has now received comments 
requesting an extension of the comment period on the proposed rule. 
Each request conveyed concern that the current 120-day comment period 
does not allow sufficient time to develop a meaningful or thoughtful 
response to the proposed rule. FDA has considered the requests and is 
granting a 120-day extension of the comment period for the proposed 
rule. FDA believes that a 120-day extension allows adequate time for 
interested persons to submit comments without significantly delaying 
rulemaking on these important issues. We also are extending the comment 
period for the information collection provisions for 120 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

[[Page 24692]]

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.''

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: April 22, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-09763 Filed 4-24-13; 11:15 am]
BILLING CODE 4160-01-P