Revisions to the California State Implementation Plan, Placer County Air Pollution Control District and the Ventura County Air Pollution Control District, 16329-16330 [2015-06857]
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Federal Register / Vol. 80, No. 59 / Friday, March 27, 2015 / Proposed Rules
asabaliauskas on DSK5VPTVN1PROD with PROPOSALS
homeopathic drug market? Are there
alternatives to the current enforcement
policies of the CPG that would inform
FDA’s regulatory oversight of drugs
labeled as homeopathic? If so, please
explain.
• Are there areas of the current CPG
that could benefit from additional
clarity? If so, please explain.
• Is there information regarding the
regulation of homeopathic products in
other countries that could inform FDA’s
thinking in this area?
• A large majority of human drug
products labeled as homeopathic are
marketed as OTC drugs. These products
are available for a wide variety of
indications, and many of these
indications have never been considered
for OTC use under a formal regulatory
process. What would be an appropriate
regulatory process for evaluating such
indications for OTC use?
• Given the wide range of indications
on drug products labeled as
homeopathic and available OTC, what
processes do companies currently use to
evaluate whether such products,
including their indications for use, are
appropriate for marketing as an OTC
drug?
• Do consumers and health care
providers have adequate information to
make informed decisions about drug
products labeled as homeopathic? If not,
what information, including, for
example, information in labeling, would
allow consumers and health care
providers to be better informed about
products labeled as homeopathic?
III. Attendance and/or Participation in
the Public Hearing
The public hearing is free and seating
will be on a first-come, first-served
basis. If you wish to make an oral
presentation during the hearing, you
must register by submitting either an
electronic or a written request by 5 p.m.
on April 13, 2015, to Lesley DeRenzo or
Cynthia Ng (see FOR FURTHER
INFORMATION CONTACT). Submit
electronic requests to
CDERHOMEOPATHICPRODUCT@
fda.hhs.gov. You must provide your
name, title, business affiliation (if
applicable), address, telephone and fax
numbers, email address, and type of
organization you represent (e.g.,
industry, consumer organization, etc.).
You also should submit a brief summary
of the presentation, including the
discussion topic(s) that will be
addressed and the approximate time
requested for your presentation. FDA
encourages individuals and
organizations with common interests to
coordinate and give a joint, consolidated
presentation. Registrants will receive
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17:40 Mar 26, 2015
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confirmation once they have been
accepted to attend the meeting. FDA
may limit both the number of
participants from individual
organizations and the total number of
attendees based on space limitations.
Registered presenters should check in
before the hearing.
Participants should submit a copy of
each presentation to Lesley DeRenzo or
Cynthia Ng (see FOR FURTHER
INFORMATION CONTACT) no later than 5
p.m. on April 13, 2015. We will file the
hearing schedule, indicating the order
and time allotted for each presenter,
with the Division of Dockets
Management (see COMMENTS AND
TRANSCRIPTS). FDA will post an
agenda of the public hearing and other
background material at least 3 days
before the public hearing, along with
additional information, at: https://
www.fda.gov/Drugs/NewsEvents/
ucm132703.htm (select this hearing
from the events list).
We will mail, email, or telephone the
schedule to each participant before the
hearing. In anticipation of the hearing
presentations moving ahead of
schedule, participants are encouraged to
arrive early to ensure their designated
order of presentation. Participants who
are not present when called risk
forfeiting their scheduled time.
If you need special accommodations
due to a disability, contact Lesley
DeRenzo or Cynthia Ng (see FOR
FURTHER INFORMATION CONTACT) at least 7
days in advance of the hearing.
IV. Notice of Hearing Under 21 CFR
Part 15
The Commissioner of Food and Drugs
is announcing that the public hearing
will be held in accordance with part 15
(21 CFR part 15). A presiding officer,
who will be accompanied by FDA
senior management from the Office of
the Commissioner and the relevant
centers, will conduct the hearing.
Under § 15.30(f), the hearing is
informal and the rules of evidence do
not apply. Only the presiding officer
and panel members may question any
person during or at the conclusion of
each presentation (§ 15.30(e)). Public
hearings under part 15 are subject to
FDA’s policy and procedures for
electronic media coverage of FDA’s
public administrative proceedings (21
CFR part 10, subpart C) (§ 10.203(a)).
Under § 10.205, representatives of the
electronic media may be permitted,
subject to certain limitations, to
videotape, film, or otherwise record
FDA’s public administrative
proceedings, including presentations by
participants. The hearing will be
transcribed as stipulated in § 15.30(b).
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16329
To the extent that the conditions for the
hearing as described in this document
conflict with any provisions set out in
part 15, this notice acts as a waiver of
those provisions as specified in
§ 15.30(h).
V. References
The following references have been
placed on display in the Division of
Dockets Management (see ADDRESSES)
and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday, and are available
electronically at https://
www.regulations.gov. (FDA has verified
all the Web site addresses in this
reference section, but we are not
responsible for any subsequent changes
to the Web sites after this document
publishes in the Federal Register.)
1. The Homeopathic Pharmacopoeia of the
United States (HPUS), ‘‘What is the
HPUS?’’, available at https://
www.hpus.com/what-is-the-hpus.php
(last visited Dec. 23, 2014).
2. Nahin, R. L., P. M. Barnes, B. J. Stussman,
and B. Bloom, ‘‘Costs of Complementary
and Alternative Medicine (CAM) and
Frequency of Visits to CAM
Practitioners: United States, 2007.’’
National Health Statistics Reports; no
18. Hyattsville, MD: National Center for
Health Statistics, 2009.
3. James B. Mowry, et al., ‘‘2012 Annual
Report of the American Association of
Poison Control Centers’ National Poison
Data System (NPDS): 30th Annual
Report,’’ 51 Clinical Toxicology, 949,
1188 (2013).
Dated: March 20, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–07018 Filed 3–26–15; 8:45 am]
BILLING CODE 4164–01–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 52
[EPA–R09–OAR–2015–0083; FRL–9924–74–
Region 9]
Revisions to the California State
Implementation Plan, Placer County
Air Pollution Control District and the
Ventura County Air Pollution Control
District
Environmental Protection
Agency (EPA).
ACTION: Proposed rule.
AGENCY:
The Environmental Protection
Agency (EPA) is proposing to approve
revisions to the Placer County Air
Pollution Control District (PCAPCD) and
the Ventura County Air Pollution
Control District (VCAPCD) portion of
SUMMARY:
E:\FR\FM\27MRP1.SGM
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asabaliauskas on DSK5VPTVN1PROD with PROPOSALS
16330
Federal Register / Vol. 80, No. 59 / Friday, March 27, 2015 / Proposed Rules
the California State Implementation
Plan (SIP). These revisions concern
volatile organic compound (VOC)
emissions from the surface coating of
plastic parts and products,
metalworking fluids and direct-contact
lubricants. We are proposing to approve
local rules to regulate these emission
sources under the Clean Air Act (CAA
or the Act).
DATE: Any comments on this proposal
must arrive by April 27, 2015.
ADDRESSES: Submit comments,
identified by docket number: EPA–R09–
OAR–2015–0083 by one of the following
methods:
1. Federal eRulemaking Portal:
www.regulations.gov. Follow the on-line
instructions.
2. Email: steckel.andrew@epa.gov.
3. Mail or deliver: Andrew Steckel
(Air-4), 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
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
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hours with the contact listed in the FOR
section.
FOR FURTHER INFORMATION CONTACT:
Arnold Lazarus, EPA Region IX, (415)
972–3024, lazarus.arnold@epa.gov.
SUPPLEMENTARY INFORMATION: This
proposal addresses the following local
rules: PCAPCD Rule 249 and VCAPCD
Rule 74.31. In the Rules and Regulations
section of this Federal Register, we are
approving these local rules 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 an
amendment, paragraph, or section of
this rule and if that provision may be
severed from the remainder of the rule,
we may adopt as final those provisions
of the rule 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.
FURTHER INFORMATION CONTACT
Dated: February 27, 2015.
Jared Blumenfeld,
Regional Administrator, Region IX.
[FR Doc. 2015–06857 Filed 3–26–15; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 52
[EPA–R03–OAR–2014–0634; FRL–9925–18–
Region 3]
Approval and Promulgation of Air
Quality Implementation Plans;
Pennsylvania; Plan Approval and
Operating Permit Fees
Environmental Protection
Agency (EPA).
ACTION: Proposed rule.
AGENCY:
The Environmental Protection
Agency (EPA) proposes to approve the
State Implementation Plan (SIP)
revision submitted by the Comonwealth
of Pennsylvania pertaining to minor
editorial revisions to Pennsylvania’s
existing plan approval and operating
permit fee rules. In the Final Rules
section of this Federal Register, EPA is
approving the State’s SIP submittal as a
direct final rule without prior proposal
because the Agency views this as a
SUMMARY:
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noncontroversial submittal and
anticipates no adverse comments. A
detailed rationale for the approval is set
forth in the direct final rule. If no
adverse comments are received in
response to this action, no further
activity is contemplated. If EPA receives
adverse comments, the direct final rule
will be withdrawn and all public
comments received will be addressed in
a subsequent final rule based on this
proposed rule. EPA will not institute a
second comment period. Any parties
interested in commenting on this action
should do so at this time.
DATES: Comments must be received in
writing by April 27, 2015.
ADDRESSES: Submit your comments,
identified by Docket ID Number EPA–
R03–OAR–2014–0634, by one of the
following methods:
A. www.regulations.gov. Follow the
on-line instructions for submitting
comments.
B. Email: Campbell.Dave@epa.gov.
C. Mail: EPA–R03–OAR–2014–0634,
Dave Campbell, Associate Director,
Office of Permits and Air Toxics,
Mailcode 3AP10, U.S. Environmental
Protection Agency, Region III, 1650
Arch Street, Philadelphia, Pennsylvania
19103.
D. Hand Delivery: At the previouslylisted EPA Region III address. Such
deliveries are only accepted during the
Docket’s normal hours of operation, and
special arrangements should be made
for deliveries of boxed information.
Instructions: Direct your comments to
Docket ID No. EPA–R03–OAR–2014–
0634. EPA’s policy is that all comments
received 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 information
claimed to be Confidential Business
Information (CBI) or other information
whose disclosure is restricted by statute.
Do not submit information that you
consider to be CBI or otherwise
protected through www.regulations.gov
or email. The www.regulations.gov Web
site is an ‘‘anonymous access’’ system,
which means EPA will not know your
identity or contact information unless
you provide it in the body of your
comment. If you send an email
comment directly to EPA without going
through www.regulations.gov, your
email address will be automatically
captured and included as part of the
comment that is placed in the public
docket and made available on the
Internet. If you submit an electronic
comment, EPA recommends that you
include your name and other contact
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]]>Agencies
[Federal Register Volume 80, Number 59 (Friday, March 27, 2015)]
[Proposed Rules]
[Pages 16329-16330]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-06857]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 52
[EPA-R09-OAR-2015-0083; FRL-9924-74-Region 9]
Revisions to the California State Implementation Plan, Placer
County Air Pollution Control District and the Ventura County Air
Pollution Control District
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve revisions to the Placer County Air Pollution Control District
(PCAPCD) and the Ventura County Air Pollution Control District (VCAPCD)
portion of
[[Page 16330]]
the California State Implementation Plan (SIP). These revisions concern
volatile organic compound (VOC) emissions from the surface coating of
plastic parts and products, metalworking fluids and direct-contact
lubricants. We are proposing to approve local rules to regulate these
emission sources under the Clean Air Act (CAA or the Act).
DATE: Any comments on this proposal must arrive by April 27, 2015.
ADDRESSES: Submit comments, identified by docket number: EPA-R09-OAR-
2015-0083 by one of the following methods:
1. Federal eRulemaking Portal: www.regulations.gov. Follow the on-
line instructions.
2. Email: steckel.andrew@epa.gov.
3. Mail or deliver: Andrew Steckel (Air-4), 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 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: Arnold Lazarus, EPA Region IX, (415)
972-3024, lazarus.arnold@epa.gov.
SUPPLEMENTARY INFORMATION: This proposal addresses the following local
rules: PCAPCD Rule 249 and VCAPCD Rule 74.31. In the Rules and
Regulations section of this Federal Register, we are approving these
local rules 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 an amendment, paragraph, or section of this rule and if that
provision may be severed from the remainder of the rule, we may adopt
as final those provisions of the rule 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: February 27, 2015.
Jared Blumenfeld,
Regional Administrator, Region IX.
[FR Doc. 2015-06857 Filed 3-26-15; 8:45 am]
BILLING CODE 6560-50-P
