Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food; Extension of Comment Periods, 69604-69605 [2013-27783]

Download as PDF 69604 Federal Register / Vol. 78, No. 224 / Wednesday, November 20, 2013 / Proposed Rules Drug Administration, 1350 Piccard Dr., PI50–400T, Rockville, MD 20850, Domini.Bean@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of July 29, 2013 (78 FR 45782), we published a proposed rule entitled ‘‘Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications’’ with a 120day comment period on the provisions of the proposed rule and on the information collection provisions that are subject to review by OMB under the PRA (44 U.S.C. 3501–3520). FDA has received requests for an extension of the comment period on the proposed rule to allow interested persons an opportunity to consider the interrelationship between this proposed rule and the proposed rule entitled ‘‘Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals’’ (78 FR 64736, October 29, 2013). FDA has considered the requests and is granting a 60-day extension of the comment period for the ‘‘Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications’’ proposed rule to allow interested persons an opportunity to consider the interrelationships between the proposed rules. We also are extending the comment period for the information collection provisions for 60 days 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. pmangrum on DSK3VPTVN1PROD with PROPOSALS-1 II. Paperwork Reduction Act of 1995 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 ‘‘Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications.’’ III. Request for Comments Interested persons may submit either electronic comments regarding the proposed rule to https:// 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 VerDate Mar<15>2010 13:59 Nov 19, 2013 Jkt 232001 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 https:// www.regulations.gov. Dated: November 13, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–27644 Filed 11–19–13; 8:45 am] BILLING CODE 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 Analysis and Risk-Based Preventive Controls for Human Food; Extension of Comment Periods AGENCY: Food and Drug Administration, HHS. Proposed rule; extension of comment period for the proposed rule and for its information collection provisions. ACTION: 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 Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food’’ and its information collection provisions. DATES: The FDA is extending the comment period for the proposed rule referenced in the Summary. Submit either electronic or written comments on the notice of proposed rulemaking by November 22, 2013. Submit comments on information 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, 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 SUMMARY: PO 00000 Frm 00011 Fmt 4702 Sfmt 4702 ‘‘Paperwork Reduction Act of 1995’’ section). Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https:// 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 https:// 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 background documents or comments received, go to https:// 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 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.’’ The original comment period of 120 days was extended several times and interested persons were most recently given until November 15, 2013 (Federal Register of August 9, 2013, 78 FR 48636), to E:\FR\FM\20NOP1.SGM 20NOP1 Federal Register / Vol. 78, No. 224 / Wednesday, November 20, 2013 / Proposed Rules comment on the proposed rule and its information collection provisions. II. Request for Comments FDA is extending the comment period due to the inability of some commenters to submit comments through the https:// www.regulations.gov 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 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 RiskBased Preventive Controls for Human Food.’’ IV. How To Submit Comments Interested persons may submit either electronic comments regarding this document to https://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 https:// www.regulations.gov. Dated: November 15, 2013. Leslie Kux, Assistant Commissioner for Policy. BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 16 and 112 [Docket No. FDA–2011–N–0921] pmangrum on DSK3VPTVN1PROD with PROPOSALS-1 RIN 0910–AG35 Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption; Extension of Comment Periods Food and Drug Administration, HHS. Proposed rule; extension of comment period for the proposed rule and for its information collection provisions. ACTION: VerDate Mar<15>2010 13:59 Nov 19, 2013 Jkt 232001 Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the instructions for submitting comments. Written Submissions [FR Doc. 2013–27783 Filed 11–15–13; 4:15 pm] AGENCY: 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 3504), entitled ‘‘Standards for the Growing, Harvesting, Packing and Holding of Produce for Human Consumption’’ and for its information collection provisions. DATES: The FDA is extending the comment period for the proposed rule referenced in the Summary. Submit either electronic or written comments on the notice of proposed rulemaking by November 22, 2013. Submit comments on information 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, 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 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). SUMMARY: 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 https:// 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 background documents or comments received, go to https:// www.regulations.gov and insert the docket number, found in brackets in the PO 00000 Frm 00012 Fmt 4702 Sfmt 4702 69605 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: Samir Assar, Center for Food Safety and Applied Nutrition (HFS–300), 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 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 3504), FDA published a proposed rule entitled ‘‘Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption.’’ The original comment period of 120 days was extended several times and interested persons were most recently given until November 15, 2013 (Federal Register of August 9, 2013, 78 FR 48637), to comment on the proposed rule and its information collection provisions. II. Request for Comments FDA is extending the comment period due to the inability of some commenters to submit comments through the https://www.regulations.gov 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 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 ‘‘Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption.’’ IV. How To Submit Comments Interested persons may submit either electronic comments regarding the proposed rule to https:// 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. E:\FR\FM\20NOP1.SGM 20NOP1

Agencies

[Federal Register Volume 78, Number 224 (Wednesday, November 20, 2013)]
[Proposed Rules]
[Pages 69604-69605]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-27783]


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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.

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

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 Practice and Hazard Analysis and Risk-
Based Preventive Controls for Human Food'' and its information 
collection provisions.

DATES: The FDA is extending the comment period for the proposed rule 
referenced in the Summary. Submit either electronic or written comments 
on the notice of proposed rulemaking by November 22, 2013. Submit 
comments on information 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, 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: https://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 https://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 background documents or 
comments received, go to https://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 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.'' The original comment period of 120 days was extended 
several times and interested persons were most recently given until 
November 15, 2013 (Federal Register of August 9, 2013, 78 FR 48636), to

[[Page 69605]]

comment on the proposed rule and its information collection provisions.

II. Request for Comments

    FDA is extending the comment period due to the inability of some 
commenters to submit comments through the https://www.regulations.gov 
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 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.''

IV. How To Submit Comments

    Interested persons may submit either electronic comments regarding 
this document to https://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 https://www.regulations.gov.

    Dated: November 15, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-27783 Filed 11-15-13; 4:15 pm]
BILLING CODE 4160-01-P
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