Pennsylvania Regulatory Program, 11617-11618 [2013-03567]
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Federal Register / Vol. 78, No. 33 / Tuesday, February 19, 2013 / Proposed Rules
§ 814.39
PMA supplements.
*
*
*
*
(c) * * *
(2) The supplement must include the
following information:
(i) Information concerning pediatric
uses as required under § 814.20(b)(13).
(ii) If information concerning the
device that is the subject of the
supplement was previously submitted
under § 814.20(b)(13) or under this
section in a previous supplement, the
applicant is not required to resubmit the
information, but may include the
information by referring to the previous
application or submission that contains
the information. However, if additional
information required under
§ 814.20(b)(13) has become readily
available to the applicant since the
previous submission, the applicant must
submit that information as part of the
supplement.
*
*
*
*
*
■ 7. In § 814.44, redesignate paragraphs
(e)(1)(ii) through (iv) as paragraphs
(e)(1)(iii) through (v), respectively, and
add new paragraph (e)(1)(ii) to read as
follows:
§ 814.44
Procedures for review of a PMA.
*
*
*
*
*
(e) * * *
(1) * * *
(ii) The submission of additional
information concerning pediatric uses
required by § 814.20(b)(13);
*
*
*
*
*
■ 8. Amend § 814.100 as follows:
■ a. Redesignate paragraphs (b) through
(e) as paragraphs (d) through (g),
respectively.
■ b. Redesignate paragraph (a) as
paragraph (b), and remove the first
sentence of newly redesignated
paragraph (b); and
■ c. Add new paragraphs (a) and (c) to
read as follows:
srobinson on DSK4SPTVN1PROD with PROPOSALS
§ 814.100
b. Revise the last sentence of
paragraph (b)(5); and
■ c. Add paragraph (b)(6).
The revisions and addition read as
follows:
■
*
§ 814.104
Original applications.
*
*
*
*
*
(b) * * *
(4) * * *
(ii) * * * The effectiveness of this
device for this use has not been
demonstrated;
(5) * * * If the amount charged is
$250 or less, the requirement for a
report by an independent certified
public accountant or an attestation by a
responsible individual of the
organization is waived; and
(6) Information concerning pediatric
uses of the device, as required by
§ 814.20(b)(13).
*
*
*
*
*
■ 10. In 814.116, redesignate paragraphs
(c)(2) through (4) as paragraphs (c)(3)
through (5), respectively, and add new
paragraph (c)(2) to read as follows:
§ 814.116
HDE.
Procedures for review of an
*
*
*
*
*
(c) * * *
(2) The submission of additional
information concerning pediatric uses of
the device, as required by
§ 814.20(b)(13);
*
*
*
*
*
Dated: February 12, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–03647 Filed 2–15–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF THE INTERIOR
Office of Surface Mining Reclamation
and Enforcement
Purpose and scope.
(a) This subpart H implements
sections 515A and 520(m) of the act.
*
*
*
*
*
(c) Section 515A of the act is intended
to ensure the submission of readily
available information concerning:
(1) Any pediatric subpopulations
(neonates, infants, children,
adolescents) that suffer from the disease
or condition that the device is intended
to treat, diagnose, or cure; and
(2) The number of affected pediatric
patients who are 21 years of age or
younger.
*
*
*
*
*
■ 9. Amend § 814.104 as follows:
■ a. Revise the last sentence of
paragraph (b)(4)(ii);
VerDate Mar<15>2010
16:48 Feb 15, 2013
Jkt 229001
30 CFR Part 938
[SATS No. PA–159–FOR; Docket ID: OSM
2010–0017]
Pennsylvania Regulatory Program
Office of Surface Mining
Reclamation and Enforcement (OSM),
Interior.
ACTION: Proposed rule; reopening of
comment period.
AGENCY:
We are reopening the public
comment period on the proposed
amendment to the Pennsylvania
regulatory program (the ‘‘Pennsylvania
program’’) under the Surface Mining
Control and Reclamation Act of 1977
(SMCRA or the Act) published on
SUMMARY:
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Fmt 4702
Sfmt 4702
11617
February 7, 2011. In response to a
required program amendment codified
in the Federal regulations, Pennsylvania
submitted information that it believes
demonstrates that sufficient funds exist
to guarantee coverage of the full cost of
land reclamation at all sites originally
permitted and bonded under its nowdefunct alternative bonding system.
Pennsylvania requested that the
program amendment be removed based
on the information provided. The
comment period is being reopened to
incorporate subsequent information that
we received from Pennsylvania
regarding one permit involving land
reclamation obligations. This document
gives the times and locations that the
Pennsylvania program and this
submittal are available for your
inspection, the comment period during
which you may submit written
comments, and the procedures that we
will follow for the public hearing, if one
is requested.
DATES: The comment period for the
proposed rule published February 7,
2011 (76 FR 6587), and extended on
June 13, 2011 (76 FR 64048), is
reopened. We will accept written
comments until 4 p.m., local time
March 6, 2013.
ADDRESSES: You may submit comments,
identified by ‘‘PA–159–FOR; Docket ID:
OSM–2010–0017’’ by either of the
following two methods:
Federal eRulemaking Portal:
www.regulations.gov. The proposed rule
has been assigned Docket ID: OSM–
2010–0017. If you would like to submit
comments through the Federal
eRulemaking Portal, go to
www.regulations.gov and follow the
instructions.
Mail/Hand Delivery/Courier:
Mr. Ben Owens, Chief, Pittsburgh Field
Division, Office of Surface Mining
Reclamation and Enforcement,
Harrisburg Transportation Center, 415
Market St., Suite 304, Harrisburg,
Pennsylvania 17101, Telephone: (717)
782–4036, Email: bowens@osmre.gov.
Thomas Callaghan, P.G., Director,
Bureau of Mining and Reclamation,
Pennsylvania Department of
Environmental Protection, Rachel
Carson State Office Building, P.O. Box
8461, Harrisburg, Pennsylvania
17105–8461, Telephone: (717) 787–
5015, Email: tcallaghan@state.pa.us
mailto:
Instructions: For detailed instructions
on submitting comments and additional
information on the rulemaking process,
see the ‘‘Public Comment Procedures’’
heading of the SUPPLEMENTARY
INFORMATION section.
E:\FR\FM\19FEP1.SGM
19FEP1
11618
Federal Register / Vol. 78, No. 33 / Tuesday, February 19, 2013 / Proposed Rules
Ben
Owens, Telephone: (717) 782–4036.
Email: bowens@osmre.gov
SUPPLEMENTARY INFORMATION: On
February 7, 2011, (76 FR 6587), we
published a proposed rule that was in
response to a required program
amendment codified in the Federal
regulations. The submission included
budgetary information that
Pennsylvania had submitted to
demonstrate that sufficient funds exist
to guarantee coverage of the full cost of
land reclamation at all sites originally
permitted and bonded under the nowdefunct alternative bonding system.
Pennsylvania requested that the
program amendment be removed based
on the information provided.
On June 13, 2011, (76 FR 64048), we
published a proposed rule to extend the
public comment period and incorporate
additional information from
Pennsylvania regarding developments
involving one permit that was
transferred to another company,
resulting in the posting of full-cost bond
in an amount to cover the land
reclamation obligation.
On November 6, 2012,
(Administrative Record Number PA
802.85), we received additional
information from Pennsylvania
regarding recent developments
involving another permit and its
bonding status. Pennsylvania requested
that the required amendment be
removed based on the information
provided.
We are reopening the comment period
to incorporate the above-referenced
subsequent information that we
received from Pennsylvania on
November 6, 2012.
FOR FURTHER INFORMATION CONTACT:
srobinson on DSK4SPTVN1PROD with PROPOSALS
Public Comment Procedures
Under the provisions of 30 CFR
732.17(h), we are seeking your
comments on whether the submission
satisfies the applicable program
approval criteria of 30 CFR 732.15. If we
approve the amendment, it will become
part of the Pennsylvania program.
Public Availability of Comments
Before including your address, phone
number, email address, or other
personal identifying information in your
comment, you should be aware that
your entire comment—including your
personal identifying information—may
be made publicly available at any time.
While you may ask us in your comment
to withhold your personal identifying
information from public review, we
cannot guarantee that we will be able to
do so. We cannot ensure that comments
received after the close of the comment
period (see DATES) or sent to an address
VerDate Mar<15>2010
16:48 Feb 15, 2013
Jkt 229001
other than those listed above (see
ADDRESSES) will be included in the
docket for this rulemaking and
considered.
Electronic or Written Comments
If you submit written comments, they
should be specific, confined to issues
pertinent to the proposed regulations,
and explain the reason for any
recommended change(s). We would
appreciate all comments relating to this
specific issue, but those most useful and
likely to influence decisions on the final
rule will be those that either involve
personal experience or include citations
to and analysis of the Surface Mining
Control and Reclamation Act of 1977, its
legislative history, its implementing
regulations, case law, other State or
Federal laws and regulations, data,
technical literature, or other relevant
publications.
List of Subjects in 30 CFR Part 938
Intergovernmental relations, Surface
mining, Underground mining.
Dated: January 25, 2013.
Thomas D. Shope,
Regional Director, Appalachian Region.
[FR Doc. 2013–03567 Filed 2–15–13; 8:45 am]
BILLING CODE 4310–05–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 52
[EPA–R04–OAR–2012–0888; FRL–9780–7]
Approval and Promulgation of
Implementation Plans Tennessee:
Revisions to Volatile Organic
Compound Definition
Environmental Protection
Agency (EPA).
ACTION: Proposed rule.
AGENCY:
EPA is proposing to approve
changes to the Tennessee State
Implementation Plan (SIP), submitted
by the State of Tennessee, through the
Tennessee Department of Environment
and Conservation on September 3, 1999.
Tennessee’s September 3, 1999, SIP
revision adds 17 compounds to the list
of compounds excluded from the
definition of ‘‘Volatile Organic
Compound’’. EPA is approving this SIP
revision because the State has
demonstrated that it is consistent with
the Clean Air Act.
In the Final Rules Section of this
Federal Register, EPA is approving the
State’s implementation plan revision as
a direct final rule without prior proposal
because the Agency views this as a
SUMMARY:
PO 00000
Frm 00015
Fmt 4702
Sfmt 4702
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 rule, 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 on this
document. Any parties interested in
commenting on this document should
do so at this time.
DATES: Written comments must be
received on or before March 21, 2013.
ADDRESSES: Submit your comments,
identified by Docket ID No. EPA–R04–
OAR–2012–0888, by one of the
following methods:
1. www.regulations.gov: Follow the
on-line instructions for submitting
comments.
2. Email: R4-RDS@epa.gov.
3. Fax: (404) 562–9019.
4. Mail: ‘‘EPA–R04–OAR–2012–
0888,’’ Regulatory Development Section,
Air Planning Branch, Air, Pesticides and
Toxics Management Division, U.S.
Environmental Protection Agency,
Region 4, 61 Forsyth Street SW.,
Atlanta, Georgia 30303–8960.
5. Hand Delivery or Courier: Lynorae
Benjamin, Chief, Regulatory
Development Section, Air Planning
Branch, Air, Pesticides and Toxics
Management Division, U.S.
Environmental Protection Agency,
Region 4, 61 Forsyth Street SW.,
Atlanta, Georgia 30303–8960. Such
deliveries are only accepted during the
Regional Office’s normal hours of
operation. The Regional Office’s official
hours of business are Monday through
Friday, 8:30 to 4:30, excluding federal
holidays.
Please see the direct final rule which
is located in the Rules section of this
Federal Register for detailed
instructions on how to submit
comments.
FOR FURTHER INFORMATION CONTACT:
Sean Lakeman, Regulatory Development
Section, Air Planning Branch, Air,
Pesticides and Toxics Management
Division, U.S. Environmental Protection
Agency, Region 4, 61 Forsyth Street
SW., Atlanta, Georgia 30303–8960. The
telephone number is (404) 562–9043.
Mr. Lakeman can be reached via
electronic mail at
lakeman.sean@epa.gov.
For
additional information see the direct
final rule which is published in the
SUPPLEMENTARY INFORMATION:
E:\FR\FM\19FEP1.SGM
19FEP1
]]>Agencies
[Federal Register Volume 78, Number 33 (Tuesday, February 19, 2013)]
[Proposed Rules]
[Pages 11617-11618]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-03567]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF THE INTERIOR
Office of Surface Mining Reclamation and Enforcement
30 CFR Part 938
[SATS No. PA-159-FOR; Docket ID: OSM 2010-0017]
Pennsylvania Regulatory Program
AGENCY: Office of Surface Mining Reclamation and Enforcement (OSM),
Interior.
ACTION: Proposed rule; reopening of comment period.
-----------------------------------------------------------------------
SUMMARY: We are reopening the public comment period on the proposed
amendment to the Pennsylvania regulatory program (the ``Pennsylvania
program'') under the Surface Mining Control and Reclamation Act of 1977
(SMCRA or the Act) published on February 7, 2011. In response to a
required program amendment codified in the Federal regulations,
Pennsylvania submitted information that it believes demonstrates that
sufficient funds exist to guarantee coverage of the full cost of land
reclamation at all sites originally permitted and bonded under its now-
defunct alternative bonding system. Pennsylvania requested that the
program amendment be removed based on the information provided. The
comment period is being reopened to incorporate subsequent information
that we received from Pennsylvania regarding one permit involving land
reclamation obligations. This document gives the times and locations
that the Pennsylvania program and this submittal are available for your
inspection, the comment period during which you may submit written
comments, and the procedures that we will follow for the public
hearing, if one is requested.
DATES: The comment period for the proposed rule published February 7,
2011 (76 FR 6587), and extended on June 13, 2011 (76 FR 64048), is
reopened. We will accept written comments until 4 p.m., local time
March 6, 2013.
ADDRESSES: You may submit comments, identified by ``PA-159-FOR; Docket
ID: OSM-2010-0017'' by either of the following two methods:
Federal eRulemaking Portal: www.regulations.gov. The proposed rule
has been assigned Docket ID: OSM-2010-0017. If you would like to submit
comments through the Federal eRulemaking Portal, go to
www.regulations.gov and follow the instructions.
Mail/Hand Delivery/Courier:
Mr. Ben Owens, Chief, Pittsburgh Field Division, Office of Surface
Mining Reclamation and Enforcement, Harrisburg Transportation Center,
415 Market St., Suite 304, Harrisburg, Pennsylvania 17101, Telephone:
(717) 782-4036, Email: bowens@osmre.gov.
Thomas Callaghan, P.G., Director, Bureau of Mining and Reclamation,
Pennsylvania Department of Environmental Protection, Rachel Carson
State Office Building, P.O. Box 8461, Harrisburg, Pennsylvania 17105-
8461, Telephone: (717) 787-5015, Email: tcallaghan@state.pa.us mailto:
Instructions: For detailed instructions on submitting comments and
additional information on the rulemaking process, see the ``Public
Comment Procedures'' heading of the SUPPLEMENTARY INFORMATION section.
[[Page 11618]]
FOR FURTHER INFORMATION CONTACT: Ben Owens, Telephone: (717) 782-4036.
Email: bowens@osmre.gov
SUPPLEMENTARY INFORMATION: On February 7, 2011, (76 FR 6587), we
published a proposed rule that was in response to a required program
amendment codified in the Federal regulations. The submission included
budgetary information that Pennsylvania had submitted to demonstrate
that sufficient funds exist to guarantee coverage of the full cost of
land reclamation at all sites originally permitted and bonded under the
now-defunct alternative bonding system. Pennsylvania requested that the
program amendment be removed based on the information provided.
On June 13, 2011, (76 FR 64048), we published a proposed rule to
extend the public comment period and incorporate additional information
from Pennsylvania regarding developments involving one permit that was
transferred to another company, resulting in the posting of full-cost
bond in an amount to cover the land reclamation obligation.
On November 6, 2012, (Administrative Record Number PA 802.85), we
received additional information from Pennsylvania regarding recent
developments involving another permit and its bonding status.
Pennsylvania requested that the required amendment be removed based on
the information provided.
We are reopening the comment period to incorporate the above-
referenced subsequent information that we received from Pennsylvania on
November 6, 2012.
Public Comment Procedures
Under the provisions of 30 CFR 732.17(h), we are seeking your
comments on whether the submission satisfies the applicable program
approval criteria of 30 CFR 732.15. If we approve the amendment, it
will become part of the Pennsylvania program.
Public Availability of Comments
Before including your address, phone number, email address, or
other personal identifying information in your comment, you should be
aware that your entire comment--including your personal identifying
information--may be made publicly available at any time. While you may
ask us in your comment to withhold your personal identifying
information from public review, we cannot guarantee that we will be
able to do so. We cannot ensure that comments received after the close
of the comment period (see DATES) or sent to an address other than
those listed above (see ADDRESSES) will be included in the docket for
this rulemaking and considered.
Electronic or Written Comments
If you submit written comments, they should be specific, confined
to issues pertinent to the proposed regulations, and explain the reason
for any recommended change(s). We would appreciate all comments
relating to this specific issue, but those most useful and likely to
influence decisions on the final rule will be those that either involve
personal experience or include citations to and analysis of the Surface
Mining Control and Reclamation Act of 1977, its legislative history,
its implementing regulations, case law, other State or Federal laws and
regulations, data, technical literature, or other relevant
publications.
List of Subjects in 30 CFR Part 938
Intergovernmental relations, Surface mining, Underground mining.
Dated: January 25, 2013.
Thomas D. Shope,
Regional Director, Appalachian Region.
[FR Doc. 2013-03567 Filed 2-15-13; 8:45 am]
BILLING CODE 4310-05-P
