Revisions to the California State Implementation Plan; Imperial County; Ozone Precursor Emissions Inventories, 63349-63350 [2014-24752]
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Federal Register / Vol. 79, No. 205 / Thursday, October 23, 2014 / Proposed Rules
professionals and discusses one of the
exceptions for establishments from
certain regulatory requirements.
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considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by December 22,
2014
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Office of Communication, Outreach, and
Development, Center for Biologics
Evaluation and Research (CBER), Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist the office in processing your
requests. The draft guidance may also be
obtained by mail by calling CBER at 1–
800–835–4709 or 240–402–7800. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the draft
guidance document.
Submit electronic comments on the
draft guidance to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Lori
J. Churchyard, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993–0002, 240–
402–7911.
SUPPLEMENTARY INFORMATION:
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I. Background
FDA is announcing the availability of
a draft document entitled ‘‘Same
Surgical Procedure Exception under 21
CFR 1271.15(b): Questions and Answers
Regarding the Scope of the Exception’’
dated October 2014. The draft guidance
document is intended for use by tissue
establishments and healthcare
professionals. When finalized, the
guidance document will provide our
current thinking with respect to the
exception set forth in Title 21 of the
Code of Federal Regulations 1271.15(b)
(21 CFR 1271.15(b)). The draft guidance
is presented in question and answer
format and includes examples based on
inquiries received by the Agency since
the final rule, ‘‘Human Cells, Tissues,
and Cellular and Tissue Based Products;
Establishment Registration and Listing’’
published in the Federal Register of
January 19, 2001 (66 FR 5447).
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The draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent FDA’s current thinking on this
topic. It does not create or confer any
rights for or on any person and does not
operate to bind FDA or the public. An
alternative approach may be used if
such approach satisfies the requirement
of the applicable statutes and
regulations.
II. Paperwork Reduction Act of 1995
The 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 21 CFR part 1271 have
been approved under OMB control
number 0910–0543.
III. Comments
The draft guidance is being
distributed for comment purposes only
and is not intended for implementation
at this time. 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 either
https://www.fda.gov/BiologicsBlood
Vaccines/GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm or https://
www.regulations.gov.
Dated: October 17, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–25217 Filed 10–22–14; 8:45 am]
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63349
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 52
[EPA–R09–OAR–2012–0542; FRL–9917–76–
Region 9]
Revisions to the California State
Implementation Plan; Imperial County;
Ozone Precursor Emissions
Inventories
Environmental Protection
Agency.
ACTION: Proposed rule.
AGENCY:
The Environmental Protection
Agency (EPA) is proposing to approve a
revision to the Imperial County portion
of the California State Implementation
Plan (SIP). This revision concerns Clean
Air Act (CAA) requirements for volatile
organic compounds and oxides of
nitrogen emissions inventories in areas
designated nonattainment for the 1997
8-hour ozone National Ambient Air
Quality Standard (NAAQS). We are
proposing to approve the 2002 volatile
organic compound and oxides of
nitrogen emissions inventories as
submitted by Imperial County and
California.
SUMMARY:
Any comments on this proposal
must arrive by November 24, 2014.
ADDRESSES: Submit comments,
identified by docket number EPA–R09–
OAR–2012–0542, by one of the
following methods:
1. Federal eRulemaking Portal:
www.regulations.gov. Follow the on-line
instructions.
2. Email: wamsley.jerry@epa.gov.
3. Mail or deliver: Jerry Wamsley (Air2), U.S. Environmental Protection
Agency Region IX, 75 Hawthorne Street,
San Francisco, CA 94105–3901.
Instructions: All comments will be
included in the public docket without
change and may be made available
online at www.regulations.gov,
including any personal information
provided, unless the comment includes
Confidential Business Information (CBI)
or other information whose disclosure is
restricted by statute. Information that
you consider CBI or otherwise protected
should be clearly identified as such and
should not be submitted through
www.regulations.gov or email.
www.regulations.gov is an ‘‘anonymous
access’’ system, and EPA will not know
your identity or contact information
unless you provide it in the body of
your comment. If you send email
directly to EPA, your email address will
be automatically captured and included
as part of the public comment. If EPA
cannot read your comment due to
DATES:
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23OCP1
63350
Federal Register / Vol. 79, No. 205 / Thursday, October 23, 2014 / Proposed Rules
technical difficulties and cannot contact
you for clarification, EPA may not be
able to consider your comment.
Electronic files should avoid the use of
special characters, any form of
encryption, and be free of any defects or
viruses.
Docket: Generally, documents in the
docket for this action are available
electronically at www.regulations.gov
and in hard copy at EPA Region IX, 75
Hawthorne Street, San Francisco,
California 94105–3901. While all
documents in the docket are listed at
www.regulations.gov, some information
may be publicly available only at the
hard copy location (e.g., copyrighted
material, large maps), and some may not
be publicly available in either location
(e.g., CBI). To inspect the hard copy
materials, please schedule an
appointment during normal business
hours with the contact listed in the FOR
FURTHER INFORMATION CONTACT section.
Jerry
Wamsley, EPA Region IX, (415) 947–
4111, wamsley.jerry@epa.gov.
FOR FURTHER INFORMATION CONTACT:
This
proposal concerns the volatile organic
compound (VOC) and oxides of nitrogen
(NOX) 2002 emissions inventories
submitted by California on December
21, 2010 in the document ‘‘Final 2009
1997 8-hour Ozone Modified Air
Quality Management Plan’’ for Imperial
County. California submitted these
emissions inventories to meet CAA
requirements under the 1997 8-hour
ozone NAAQS. In the Rules and
Regulations section of this Federal
Register, we are approving these VOC
and NOX emissions inventories
provided by California in a direct final
action without prior proposal because
we believe these SIP revisions are not
controversial. If we receive adverse
comments, however, we will publish a
timely withdrawal of the direct final
rule and address the comments in
subsequent action based on this
proposed rule. Please note that if we
receive adverse comment on a portion of
the state’s submittal and if that
provision may be severed from the
remainder of the submittal, we may
adopt as final those provisions of the
submittal that are not the subject of an
adverse comment.
We do not plan to open a second
comment period, so anyone interested
in commenting should do so at this
time. If we do not receive adverse
comments, no further activity is
planned. For further information, please
see the direct final action.
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SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
16:37 Oct 22, 2014
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Dated: September 24, 2014.
Jared Blumenfeld,
Regional Administrator, Region IX.
[FR Doc. 2014–24752 Filed 10–22–14; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 52
[EPA–R09–OAR–2014–0547; FRL–9918–39–
Region 9]
Partial Approval and Partial
Disapproval of Air Quality State
Implementation Plans; California;
Infrastructure Requirements for Ozone,
Fine Particulate Matter (PM2.5), Lead
(Pb), Nitrogen Dioxide (NO2), and
Sulfur Dioxide (SO2)
Environmental Protection
Agency (EPA).
ACTION: Proposed rule.
AGENCY:
The Environmental Protection
Agency (EPA) is proposing to partially
approve and partially disapprove
several State Implementation Plan (SIP)
revisions submitted by the State of
California pursuant to the requirements
of the Clean Air Act (CAA or the Act)
for the implementation, maintenance,
and enforcement of national ambient air
quality standards (NAAQS) for ozone,
fine particulate patter (PM2.5), lead (Pb),
nitrogen dioxide (NO2), and sulfur
dioxide (SO2). We refer to such SIP
revisions as ‘‘infrastructure’’ SIPs
because they are intended to address
basic structural SIP requirements for
new or revised NAAQS including, but
not limited to, legal authority,
regulatory structure, resources, permit
programs, and monitoring necessary to
assure attainment and maintenance of
the standards. In addition, we are
proposing to reclassify certain regions of
the state for emergency episode
planning purposes with respect to
ozone, NO2, SO2, and particulate matter
(PM). Finally, we are proposing to
approve into the SIP several state
provisions addressing CAA conflict of
interest requirements into the California
SIP and an emergency episode planning
rule for Great Basin Unified Air
Pollution Control District (APCD) for
PM. We are taking comments on this
proposal and, after considering any
comments submitted, plan to take final
action.
DATES: Written comments must be
received on or before November 24,
2014.
SUMMARY:
Submit your comments,
identified by Docket ID Number EPA–
ADDRESSES:
PO 00000
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R09–OAR–2014–0547, by one of the
following methods:
1. https://www.regulations.gov: Follow
the on-line instructions for submitting
comments.
2. Email: mays.rory@epa.gov.
3. Mail or deliver: Rory Mays (AIR–2),
U.S. Environmental Protection Agency,
Region IX, 75 Hawthorne Street, San
Francisco, CA 94105–3901. Deliveries
are only accepted during the Regional
Office’s normal hours of operation.
Instructions: All comments will be
included in the public docket without
change and may be made available
online at https://www.regulations.gov,
including any personal information
provided, unless the comment includes
Confidential Business Information (CBI)
or other information whose disclosure is
restricted by statute. Information that
you consider CBI or otherwise protected
should be clearly identified as such and
should not be submitted through
https://www.regulations.gov or email.
https://www.regulations.gov is an
anonymous access system, and EPA will
not know your identity or contact
information unless you provide it in the
body of your comment. If you send
email directly to EPA, your email
address will be automatically captured
and included as part of the public
comment. If EPA cannot read your
comment due to technical difficulties
and cannot contact you for clarification,
EPA may not be able to consider your
comment.
Docket: Generally, documents in the
docket for this action are available
electronically at www.regulations.gov
and in hard copy at EPA Region IX, 75
Hawthorne Street, San Francisco,
California. While all documents in the
docket are listed at
www.regulations.gov, some information
may be publicly available only at the
hard copy location (e.g., copyrighted
material, large maps), and some may not
be publicly available in either location
(e.g., CBI). To inspect the hard copy
materials, please schedule an
appointment during normal business
hours with the contact listed in the FOR
FURTHER INFORMATION CONTACT section.
FOR FURTHER INFORMATION CONTACT: Rory
Mays, Air Planning Office (AIR–2), U.S.
Environmental Protection Agency,
Region IX, (415) 972–3227, mays.rory@
epa.gov.
SUPPLEMENTARY INFORMATION:
Throughout this document, the terms
‘‘we,’’ ‘‘us,’’ and ‘‘our’’ refer to EPA.
Table of Contents
I. EPA’s Approach to the Review of
Infrastructure SIP Submittals
II. Background
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Agencies
[Federal Register Volume 79, Number 205 (Thursday, October 23, 2014)]
[Proposed Rules]
[Pages 63349-63350]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-24752]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 52
[EPA-R09-OAR-2012-0542; FRL-9917-76-Region 9]
Revisions to the California State Implementation Plan; Imperial
County; Ozone Precursor Emissions Inventories
AGENCY: Environmental Protection Agency.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve a revision to the Imperial County portion of the California
State Implementation Plan (SIP). This revision concerns Clean Air Act
(CAA) requirements for volatile organic compounds and oxides of
nitrogen emissions inventories in areas designated nonattainment for
the 1997 8-hour ozone National Ambient Air Quality Standard (NAAQS). We
are proposing to approve the 2002 volatile organic compound and oxides
of nitrogen emissions inventories as submitted by Imperial County and
California.
DATES: Any comments on this proposal must arrive by November 24, 2014.
ADDRESSES: Submit comments, identified by docket number EPA-R09-OAR-
2012-0542, by one of the following methods:
1. Federal eRulemaking Portal: www.regulations.gov. Follow the on-
line instructions.
2. Email: wamsley.jerry@epa.gov.
3. Mail or deliver: Jerry Wamsley (Air-2), U.S. Environmental
Protection Agency Region IX, 75 Hawthorne Street, San Francisco, CA
94105-3901.
Instructions: All comments will be included in the public docket
without change and may be made available online at www.regulations.gov,
including any personal information provided, unless the comment
includes Confidential Business Information (CBI) or other information
whose disclosure is restricted by statute. Information that you
consider CBI or otherwise protected should be clearly identified as
such and should not be submitted through www.regulations.gov or email.
www.regulations.gov is an ``anonymous access'' system, and EPA will not
know your identity or contact information unless you provide it in the
body of your comment. If you send email directly to EPA, your email
address will be automatically captured and included as part of the
public comment. If EPA cannot read your comment due to
[[Page 63350]]
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses.
Docket: Generally, documents in the docket for this action are
available electronically at www.regulations.gov and in hard copy at EPA
Region IX, 75 Hawthorne Street, San Francisco, California 94105-3901.
While all documents in the docket are listed at www.regulations.gov,
some information may be publicly available only at the hard copy
location (e.g., copyrighted material, large maps), and some may not be
publicly available in either location (e.g., CBI). To inspect the hard
copy materials, please schedule an appointment during normal business
hours with the contact listed in the FOR FURTHER INFORMATION CONTACT
section.
FOR FURTHER INFORMATION CONTACT: Jerry Wamsley, EPA Region IX, (415)
947-4111, wamsley.jerry@epa.gov.
SUPPLEMENTARY INFORMATION: This proposal concerns the volatile organic
compound (VOC) and oxides of nitrogen (NOX) 2002 emissions
inventories submitted by California on December 21, 2010 in the
document ``Final 2009 1997 8-hour Ozone Modified Air Quality Management
Plan'' for Imperial County. California submitted these emissions
inventories to meet CAA requirements under the 1997 8-hour ozone NAAQS.
In the Rules and Regulations section of this Federal Register, we are
approving these VOC and NOX emissions inventories provided
by California in a direct final action without prior proposal because
we believe these SIP revisions are not controversial. If we receive
adverse comments, however, we will publish a timely withdrawal of the
direct final rule and address the comments in subsequent action based
on this proposed rule. Please note that if we receive adverse comment
on a portion of the state's submittal and if that provision may be
severed from the remainder of the submittal, we may adopt as final
those provisions of the submittal that are not the subject of an
adverse comment.
We do not plan to open a second comment period, so anyone
interested in commenting should do so at this time. If we do not
receive adverse comments, no further activity is planned. For further
information, please see the direct final action.
Dated: September 24, 2014.
Jared Blumenfeld,
Regional Administrator, Region IX.
[FR Doc. 2014-24752 Filed 10-22-14; 8:45 am]
BILLING CODE 6560-50-P