[Federal Register Volume 78, Number 154 (Friday, August 9, 2013)]
[Proposed Rules]
[Pages 48637-48638]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-19302]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 16 and 112
[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.
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, ``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 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-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).
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-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 ``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:
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 Piccard Drive, PI50-400T, Rockville, MD 20850,
[email protected].
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
[[Page 48638]]
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 and for the
information collection provisions--i.e., until September 16, 2013
(Federal Register of April 26, 2013, 78 FR 24692). 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 ``Standards for the Growing, Harvesting,
Packing, and Holding of Produce for Human Consumption.'' Therefore, FDA
is granting a 60-day final extension of the comment period for the
``Standards for the Growing, Harvesting, Packing, and Holding of
Produce for Human Consumption'' proposed rule to allow interested
persons 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 ``Standards for the Growing, Harvesting,
Packing, and Holding of Produce for Human Consumption.''
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. 2013-19302 Filed 8-8-13; 8:45 am]
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