Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption; Extension of Comment Period for Information Collection Provisions, 11611-11612 [2013-03778]
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Federal Register / Vol. 78, No. 33 / Tuesday, February 19, 2013 / Proposed Rules
must also be determined. Loads must be
determined for critical fuel and payload
distributions and centers of gravity.
Nose gear loads, as well as airframe
loads, must be determined. The airplane
must support these loads as described in
§ 25.305.
Issued in Renton, Washington, on February
12, 2013.
Ali Bahrami,
Manager, Transport Airplane Directorate,
Aircraft Certification Service.
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 RiskBased Preventive Controls for Human
Food.’’
FOR FURTHER INFORMATION CONTACT:
BILLING CODE 4910–13–P
Domini Bean, Office of Information
Management, Food and Drug
Administration, 1350 Picard Dr., PI50–
400T, Rockville, MD 20850,
Domini.Bean@fda.hhs.gov.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
SUPPLEMENTARY INFORMATION:
[FR Doc. 2013–03679 Filed 2–15–13; 8:45 am]
I. Background
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.
Proposed rule; extension of
comment period for information
collection provisions.
ACTION:
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
srobinson on DSK4SPTVN1PROD with PROPOSALS
SUMMARY:
VerDate Mar<15>2010
16:48 Feb 15, 2013
Jkt 229001
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 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). 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 riskbased 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
PO 00000
Frm 00008
Fmt 4702
Sfmt 4702
11611
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
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 Period for Information
Collection Provisions
AGENCY:
Food and Drug Administration,
HHS.
Proposed rule; extension of
comment period for information
collection provisions.
ACTION:
The Food and Drug
Administration (FDA or ‘‘we’’) is
extending the comment period for the
information collection provisions of the
proposed rule on ‘‘Standards for the
Growing, Harvesting, Packing, and
Holding of Produce for Human
Consumption’’ 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 3504), is extended. Submit
SUMMARY:
E:\FR\FM\19FEP1.SGM
19FEP1
11612
Federal Register / Vol. 78, No. 33 / Tuesday, February 19, 2013 / Proposed Rules
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 ‘‘Standards for the Growing,
Harvesting, Packing, and Holding of
Produce for Human Consumption.’’
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.
srobinson on DSK4SPTVN1PROD with PROPOSALS
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’’ 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 establish science-based
minimum standards for the safe
growing, harvesting, packing, and
holding of produce for human
consumption to minimize the risk of
serious adverse health consequences or
death from consumption of
contaminated produce.
We have received a request for a 90day extension of the comment period for
the information collection provisions of
the proposed rule. The request
conveyed concern that the current 30day comment period does not allow
sufficient time to provide meaningful
input on the information collection
provisions submitted to OMB under the
Paperwork Reduction Act of 1995.
We have considered the request 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
16:48 Feb 15, 2013
Jkt 229001
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 ‘‘Standards for
the Growing, Harvesting, Packing, and
Holding of Produce for Human
Consumption.’’
Dated: February 13, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–03778 Filed 2–15–13; 8:45 am]
BILLING CODE 4160–01–P
SUPPLEMENTARY INFORMATION:
VerDate Mar<15>2010
same as the comment period for the
provisions of the proposed rule.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 814
[Docket No. FDA–2009–N–0458]
RIN 0910–AG29
Medical Devices; Pediatric Uses of
Devices; Requirement for Submission
of Information on Pediatric
Subpopulations That Suffer From a
Disease or Condition That a Device Is
Intended To Treat, Diagnose, or Cure
AGENCY:
Food and Drug Administration,
HHS.
Supplemental notice of
proposed rulemaking.
ACTION:
The Food and Drug
Administration (FDA) published a
proposed rule in the Federal Register of
April 1, 2010, along with a companion
direct final rule. The proposed rule
proposed to amend the regulations on
premarket approval of medical devices
to include requirements relating to the
submission of information on pediatric
subpopulations that suffer from the
disease or condition that a device is
intended to treat, diagnose, or cure. The
Agency received significant adverse
comment and withdrew the direct final
rule. The Agency is issuing this
supplemental notice of proposed
rulemaking re-proposing the
amendments reflecting comments
received.
DATES: Submit either electronic or
written comments on the proposed rule
by April 22, 2013. Submit comments on
information collection issues under the
Paperwork Reduction Act of 1995 by
SUMMARY:
PO 00000
Frm 00009
Fmt 4702
Sfmt 4702
March 21, 2013, (see the ‘‘Paperwork
Reduction Act of 1995’’ section of this
document).
You may submit comments,
identified by Docket No. FDA–2009–N–
0458 and/or RIN number 0910–AG29,
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).
ADDRESSES:
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–2009–N–0458 and
Regulatory Information Number (RIN)
0910–AG29 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 ‘‘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:
Sheila Brown, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Avenue, Bldg. 66, Rm. 1651, Silver
Spring, MD 20993, 301–796–6563.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\19FEP1.SGM
19FEP1
]]>Agencies
[Federal Register Volume 78, Number 33 (Tuesday, February 19, 2013)]
[Proposed Rules]
[Pages 11611-11612]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-03778]
-----------------------------------------------------------------------
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 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 provisions of the
proposed rule on ``Standards for the Growing, Harvesting, Packing, and
Holding of Produce for Human Consumption'' 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 3504), is extended. Submit
[[Page 11612]]
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 ``Standards for the
Growing, Harvesting, Packing, and Holding of Produce for Human
Consumption.''
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 3504), FDA
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). Comments on the provisions of the rule and
on the information collection provisions will inform FDA's rulemaking
to establish science-based minimum standards for the safe growing,
harvesting, packing, and holding of produce for human consumption to
minimize the risk of serious adverse health consequences or death from
consumption of contaminated produce.
We have received a request for a 90-day extension of the comment
period for the information collection provisions of the proposed rule.
The request conveyed concern that the current 30-day comment period
does not allow sufficient time to provide meaningful input on the
information collection provisions submitted to OMB under the Paperwork
Reduction Act of 1995.
We have considered the request 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 ``Standards for the Growing, Harvesting,
Packing, and Holding of Produce for Human Consumption.''
Dated: February 13, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-03778 Filed 2-15-13; 8:45 am]
BILLING CODE 4160-01-P
