Draft Guidance for Industry: Questions and Answers Regarding the Final Rule, Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation (Layers With Outdoor Access); Availability, 44483-44484 [2013-17750]
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Federal Register / Vol. 78, No. 142 / Wednesday, July 24, 2013 / Proposed Rules
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ehiers on DSK2VPTVN1PROD with PROPOSALS-1
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[FR Doc. 2013–17730 Filed 7–23–13; 8:45 am]
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Food and Drug Administration
that office in processing your request.
See the SUPPLEMENTARY INFORMATION
section for electronic access to the draft
guidance.
21 CFR Part 118
FOR FURTHER INFORMATION CONTACT:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2000–N–0190 (formerly
Docket No. 2000N–0504)]
Draft Guidance for Industry: Questions
and Answers Regarding the Final Rule,
Prevention of Salmonella Enteritidis in
Shell Eggs During Production,
Storage, and Transportation (Layers
With Outdoor Access); Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or we) is
announcing the availability of a draft
guidance entitled ‘‘Guidance for
Industry: Questions and Answers
Regarding the Final Rule, Prevention of
Salmonella Enteritidis in Shell Eggs
During Production, Storage, and
Transportation (Layers with Outdoor
Access)’’ (the draft guidance). The
document provides guidance to egg
producers on certain provisions
contained in FDA’s final rule entitled,
‘‘Prevention of Salmonella Enteritidis in
Shell Eggs During Production, Storage,
and Transportation’’ concerning the
management of production systems that
provide laying hens with access to the
outdoors. Laying hens are provided
outdoor access in some production
systems, including certified organic
production systems governed by the
U.S. Department of Agriculture’s
National Organic Program regulations.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comments on the draft
guidance before it begins work on the
final version of the guidance, submit
electronic or written comments on the
draft guidance by September 23, 2013.
ADDRESSES: Submit electronic
comments on the draft guidance to
https://www.regulations.gov. Submit
written comments on the draft guidance
to the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. Submit
written requests for single copies of the
draft guidance to the Division of Plant
and Dairy Food Safety/Office of Food
Safety, Center for Food Safety and
Applied Nutrition (HFS–315), Food and
Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740, or fax
your request to 301–436–2632. Send one
self-addressed adhesive label to assist
SUMMARY:
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Nancy Bufano, Center for Food Safety
and Applied Nutrition (HFS–316), Food
and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740,
240–402–1493.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of July 9, 2009
(74 FR 33030), FDA issued a final rule
requiring shell egg producers to
implement measures to prevent
Salmonella Enteritidis (SE) from
contaminating eggs on the farm and
from further growth during storage and
transportation, and requiring these
producers to maintain records
concerning their compliance with the
final rule and to register with FDA. The
final rule became effective September 8,
2009, with a compliance date of July 9,
2010, for producers with 50,000 or more
laying hens. For producers with fewer
than 50,000, but at least 3,000 laying
hens, the compliance date was July 9,
2012. The compliance date for persons
who must comply with only the
refrigeration requirements was July 9,
2010. The final rule is codified at 21
CFR part 118.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent our current thinking on how
to interpret the requirements in the final
rule with regard to production systems
that provide laying hens with access to
the outdoors, including questions and
answers on coverage; definitions; SE
prevention measures; and
environmental sampling for SE. It does
not create or confer any rights for or on
any person and does not operate to bind
FDA or the public. An alternate
approach may be used if such approach
satisfies the requirements of the
applicable statutes and regulations.
II. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in §§ 118.5, 118.6,
118.10, and 118.11 have been approved
under OMB control number 0910–0660.
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Federal Register / Vol. 78, No. 142 / Wednesday, July 24, 2013 / Proposed Rules
III. 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.
IV. Electronic Access
Persons with access to the Internet
may obtain the draft guidance at https://
www.fda.gov/RegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov. Use the FDA Web
site listed in the previous sentence to
find the most current version of the
guidance.
Dated: July 8, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–17750 Filed 7–23–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 1140
[Docket No. FDA–2013–N–0521]
Menthol in Cigarettes, Tobacco
Products; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Advance notice of proposed
rulemaking.
ACTION:
The Food and Drug
Administration (FDA) is issuing this
advance notice of proposed rulemaking
(ANPRM) to obtain information related
to the potential regulation of menthol in
cigarettes. FDA is also making available
its preliminary scientific evaluation of
public health issues related to the use of
menthol in cigarettes. The preliminary
scientific evaluation indicates there is
likely a public health impact of menthol
in cigarettes. This ANPRM is seeking
comments, including comments on
FDA’s preliminary evaluation, and data,
research, or other information that may
inform regulatory actions FDA might
take with respect to menthol in
cigarettes.
ehiers on DSK2VPTVN1PROD with PROPOSALS-1
SUMMARY:
VerDate Mar<15>2010
15:33 Jul 23, 2013
Submit either electronic or
written comments by September 23,
2013.
DATES:
Jkt 229001
You may submit comments,
identified by Docket No. FDA–2013–N–
0521, by any of the following methods:
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–2013–N–0521 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:
Annette L. Marthaler, Center for
Tobacco Products, Food and Drug
Administration, 9200 Corporate Blvd.,
Rockville, MD 20850–3229, 877–287–
1373, CTPRegulations@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
The Family Smoking Prevention and
Tobacco Control Act, enacted on June
22, 2009, amends the Federal Food,
Drug, and Cosmetic Act (the FD&C Act)
and provides FDA with the authority to
regulate tobacco products (Pub. L. 111–
31, 123 Stat. 1776). Among other things,
section 907(e) of the FD&C Act (21
U.S.C 387g(e)) requires FDA’s Tobacco
Products Scientific Advisory Committee
(TPSAC) to submit a report and
recommendations to the Secretary of
Health and Human Services (the
Secretary of HHS) on the impact of the
use of menthol in cigarettes on the
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public health, including use among
children, African Americans, Hispanics,
and other racial/ethnic minorities.
TPSAC has submitted the report to
HHS, available at https://www.fda.gov/
downloads/AdvisoryCommittees/
CommitteesMeetingMaterials/Tobacco
ProductsScientificAdvisoryCommittee/
UCM269697.pdf. In addition, the
nonvoting industry representatives of
TPSAC submitted a separate document
reflecting the industry perspective,
available at https://www.fda.gov/
downloads/AdvisoryCommittees/
CommitteesMeetingMaterials/Tobacco
ProductsScientificAdvisoryCommittee/
UCM249320.pdf. Two cigarette
manufacturers have challenged FDA’s
ability to rely on TPSAC’s menthol
report, and that case is currently
pending (Lorillard, Inc. v. FDA, No. 11–
440 (D.D.C.)).
Experts within FDA’s Center for
Tobacco Products (CTP) also initiated
an independent evaluation of the
available science related to the impact
of the use of menthol in cigarettes on
public health including peer-reviewed
literature, secondary data analyses, and
independent CTP analyses of relevant
large data sets. This preliminary
independent evaluation is entitled
‘‘Preliminary Scientific Evaluation of
the Possible Public Health Effects of
Menthol Versus Nonmenthol Cigarettes’’
(the evaluation) (Ref. 1). The evaluation
has been peer reviewed, and the peer
review report is available on FDA’s Web
site at https://www.fda.gov/Science
Research/SpecialTopics/PeerReviewof
ScientificInformationandAssessments/
ucm079120.htm. FDA is also making
available an addendum with articles
published since the evaluation was
submitted for peer review in 2011
(Ref. 2).
As discussed previously, the FD&C
Act provides FDA with authority to
regulate tobacco products. This includes
authority to adopt a tobacco product
standard under section 907 of the FD&C
Act if the Secretary of HHS finds that a
tobacco product standard is appropriate
for the protection of public health and
includes authority to amend an existing
product standard. In making such a
finding, the Secretary of HHS must
consider scientific evidence concerning:
(1) The risks and benefits to the
population as a whole, including users
and nonusers of tobacco products, of the
product standard; (2) the increased or
decreased likelihood that existing users
of tobacco products will stop using such
products; and (3) the increased or
decreased likelihood that those who do
not use tobacco products will start using
such products. The FD&C Act also
provides FDA with authority to, by
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]]>Agencies
[Federal Register Volume 78, Number 142 (Wednesday, July 24, 2013)]
[Proposed Rules]
[Pages 44483-44484]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-17750]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 118
[Docket No. FDA-2000-N-0190 (formerly Docket No. 2000N-0504)]
Draft Guidance for Industry: Questions and Answers Regarding the
Final Rule, Prevention of Salmonella Enteritidis in Shell Eggs During
Production, Storage, and Transportation (Layers With Outdoor Access);
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is announcing the
availability of a draft guidance entitled ``Guidance for Industry:
Questions and Answers Regarding the Final Rule, Prevention of
Salmonella Enteritidis in Shell Eggs During Production, Storage, and
Transportation (Layers with Outdoor Access)'' (the draft guidance). The
document provides guidance to egg producers on certain provisions
contained in FDA's final rule entitled, ``Prevention of Salmonella
Enteritidis in Shell Eggs During Production, Storage, and
Transportation'' concerning the management of production systems that
provide laying hens with access to the outdoors. Laying hens are
provided outdoor access in some production systems, including certified
organic production systems governed by the U.S. Department of
Agriculture's National Organic Program regulations.
DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comments on the
draft guidance before it begins work on the final version of the
guidance, submit electronic or written comments on the draft guidance
by September 23, 2013.
ADDRESSES: Submit electronic comments on the draft guidance to https://www.regulations.gov. Submit written comments on the draft guidance to
the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Submit written requests for single copies of the draft guidance to the
Division of Plant and Dairy Food Safety/Office of Food Safety, Center
for Food Safety and Applied Nutrition (HFS-315), Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or fax
your request to 301-436-2632. Send one self-addressed adhesive label to
assist that office in processing your request. See the SUPPLEMENTARY
INFORMATION section for electronic access to the draft guidance.
FOR FURTHER INFORMATION CONTACT: Nancy Bufano, Center for Food Safety
and Applied Nutrition (HFS-316), Food and Drug Administration, 5100
Paint Branch Pkwy., College Park, MD 20740, 240-402-1493.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of July 9, 2009 (74 FR 33030), FDA issued a
final rule requiring shell egg producers to implement measures to
prevent Salmonella Enteritidis (SE) from contaminating eggs on the farm
and from further growth during storage and transportation, and
requiring these producers to maintain records concerning their
compliance with the final rule and to register with FDA. The final rule
became effective September 8, 2009, with a compliance date of July 9,
2010, for producers with 50,000 or more laying hens. For producers with
fewer than 50,000, but at least 3,000 laying hens, the compliance date
was July 9, 2012. The compliance date for persons who must comply with
only the refrigeration requirements was July 9, 2010. The final rule is
codified at 21 CFR part 118.
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent our current thinking on how to interpret the
requirements in the final rule with regard to production systems that
provide laying hens with access to the outdoors, including questions
and answers on coverage; definitions; SE prevention measures; and
environmental sampling for SE. It does not create or confer any rights
for or on any person and does not operate to bind FDA or the public. An
alternate approach may be used if such approach satisfies the
requirements of the applicable statutes and regulations.
II. Paperwork Reduction Act of 1995
This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in Sec. Sec. 118.5, 118.6, 118.10, and
118.11 have been approved under OMB control number 0910-0660.
[[Page 44484]]
III. 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.
IV. Electronic Access
Persons with access to the Internet may obtain the draft guidance
at https://www.fda.gov/RegulatoryInformation/Guidances/default.htm or
https://www.regulations.gov. Use the FDA Web site listed in the previous
sentence to find the most current version of the guidance.
Dated: July 8, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-17750 Filed 7-23-13; 8:45 am]
BILLING CODE 4160-01-P
