Regulatory Review Schedule; Cancellation of Consultation Meetings, 47089-47090 [2011-19808]
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47089
Federal Register / Vol. 76, No. 150 / Thursday, August 4, 2011 / Proposed Rules
TABLE 1—SUMMARY OF ELECTRONIC REGISTRATION AND LISTING INFORMATION
Device name
Product code
510(k) or
PMA?
Last listed
Last marketed
Replaced
by approved
technology?
Pacemaker Programmer ......................................................
KRG
510(k)
2011
1990s
Yes
Based on our review of electronic
product registration and listing and
other data, FDA concludes that there is
currently little or no interest in
marketing the affected devices and that
the proposed rule would not have a
significant economic impact. We
specifically request detailed comment
regarding the appropriateness of our
assumptions regarding the potential
economic impact of this proposed rule.
X. Federalism
FDA has analyzed this proposed rule
in accordance with the principles set
forth in Executive Order 13132. FDA
has determined that the proposed rule,
if finalized, would not contain policies
that would have substantial direct
effects on the States, on the relationship
between the National Government and
the States, or on the distribution of
power and responsibilities among the
various levels of government.
Accordingly, the agency tentatively
concludes that the proposed rule does
not contain policies that have
federalism implications as defined in
the Executive order and, consequently,
a federalism summary impact statement
is not required.
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XI. Paperwork Reduction Act of 1995
This proposed rule 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 812 have
been approved under OMB Control No.
0910–0078; the collections of
information in 21 CFR part 807 subpart
E have been approved under OMB
Control No. 0910–0120; the collections
of information in 21 CFR 814 subpart B
have been approved under OMB Control
No. 0910–0231; and the collections of
information under 21 CFR 801 have
been approved under OMB Control No.
0910–0485.
XII. Proposed Effective Date
FDA is proposing that any final rule
based on this proposal become effective
on the date of its publication in the
Federal Register or at a later date if
stated in the final rule.
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XIII. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding this document. It is
only necessary to send one set of
comments. It is no longer necessary to
send two copies of mailed 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.
List of Subjects in 21 CFR Part 870
Medical devices.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs, it is proposed that
21 CFR part 870 be amended as follows:
PART 870—CARDIOVASCULAR
DEVICES
1. The authority citation for 21 CFR
part 870 continues to read as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e,
360j, 371.
2. Section 870.3700 is amended by
revising paragraphs (a) and (c) to read as
follows:
§ 870.3700
Pacemaker programmers.
(a) Identification. A pacemaker
programmer is a device used to
noninvasively change one or more of the
electrical operating characteristics of a
pacemaker.
(b) * * *
(c) Date PMA or notice of completion
of PDP is required. A PMA or notice of
completion of a PDP is required to be
filed with the Food and Drug
Administration on or before November
2, 2011, for any pacemaker programmer
that was in commercial distribution
before May 28, 1976, or that has, on or
before November 2, 2011, been found to
be substantially equivalent to any
pacemaker programmer that was in
commercial distribution before May 28,
1976. Any other pacemaker programmer
shall have an approved PMA or
declared completed PDP in effect before
being placed in commercial
distribution.
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Dated: July 29, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices
and Radiological Health.
[FR Doc. 2011–19733 Filed 8–3–11; 8:45 am]
BILLING CODE P
DEPARTMENT OF THE INTERIOR
National Indian Gaming Commission
25 CFR Chapter III
Regulatory Review Schedule;
Cancellation of Consultation Meetings
National Indian Gaming
Commission.
ACTION: Notice.
AGENCY:
On November 18, 2010, the
National Indian Gaming Commission
(NIGC) issued a Notice of Inquiry and
Notice of Consultation advising the
public that the NIGC was conducting a
comprehensive review of its regulations
and requesting public comment on the
process for conducting the regulatory
review. On April 4, 2011, after holding
eight consultations and reviewing all
comments, NIGC published a Notice of
Regulatory Review Schedule setting out
a consultation schedule and process for
review. The purpose of this document is
to cancel four scheduled tribal
consultations.
SUMMARY:
DATES: See SUPPLEMENTARY INFORMATION
below for dates and locations of
cancelled consultations.
FOR FURTHER INFORMATION CONTACT: Lael
Echo-Hawk, National Indian Gaming
Commission, 1441 L Street NW., Suite
9100 Washington, DC 20005.
Telephone: 202–632–7003; e-mail:
reg.review@nigc.gov.
On
November 18, 2010, the National Indian
Gaming Commission (NIGC) issued a
Notice of Inquiry and Notice of
Consultation advising the public that it
was conducting a review of its
regulations promulgated to implement
25 U.S.C. 2701–2721 of the Indian
Gaming Regulatory Act (IGRA) and
requesting public comment on the
process for conducting the regulatory
review. On April 4, 2011, after holding
eight consultations and reviewing all
SUPPLEMENTARY INFORMATION:
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47090
Federal Register / Vol. 76, No. 150 / Thursday, August 4, 2011 / Proposed Rules
comments, NIGC published a Notice of
Regulatory Review Schedule in the
Federal Register setting out
consultation schedules and review
processes. (76 FR 18457, April 4, 2011).
The Commission’s regulatory review
process establishes a tribal consultation
schedule with a description of the
regulation groups to be covered at each
consultation. This document advises the
public that the following tribal
consultations have been cancelled.
Consultation date
Event
Location
August 25–26, 2011 ...............................
NIGC Consultation—Southwest .............
September 19–20, 2011 .........................
September 27–28, 2011 .........................
November 7–12, 2011 ............................
NIGC Regional Training .........................
NIGC Consultation—Northeast ..............
USET Annual Meeting ...........................
Wild Horse Resort Casino, Scottsdale,
AZ.
Sky Ute Casino Resort Ignacio, CO ......
Turning Stone Casino, NY .....................
Mississippi Choctaw, MS .......................
For additional information on
consultation locations and times, please
refer to the Web site of the National
Indian Gaming Commission, https://
www.nigc.gov.
Dated: August 1, 2011, Washington, DC.
Tracie L. Stevens,
Chairwoman.
Steffani A. Cochran,
Vice-Chairwoman.
Daniel J. Little,
Associate Commissioner.
[FR Doc. 2011–19808 Filed 8–3–11; 8:45 am]
BILLING CODE P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 52
[EPA–R03–OAR–2011–0623; FRL–9448–1]
Approval and Promulgation of Air
Quality Implementation Plans;
Maryland; Preconstruction Permitting
Requirements for Electric Generating
Stations in Maryland
Environmental Protection
Agency (EPA).
ACTION: Proposed rule.
AGENCY:
EPA is proposing to approve
a State Implementation Plan (SIP)
revision submitted by the Maryland
Department of the Environment (MDE)
on May 13, 2011 and July 15, 2011. This
SIP revision revises and supplements
the preconstruction permitting
requirements for electric generating
stations that are required to receive a
Certificate of Public Convenience and
Necessity (CPCN) from the Maryland
Public Service Commission (PSC) before
commencing construction. The SIP
revision also requires electric generating
stations to obtain a preconstruction
permit from the MDE when a CPCN is
not required under the PSC regulations
and statutes. This action is being taken
under the Clean Air Act (CAA).
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SUMMARY:
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Written comments must be
received on or before September 6,
2011.
ADDRESSES: Submit your comments,
identified by Docket ID Number EPA–
R03–OAR–2011–0623 by one of the
following methods:
1. https://www.regulations.gov. Follow
the on-line instructions for submitting
comments.
2. E-mail: cox.kathleen@epa.gov.
3. Mail: EPA–R03–OAR–2011–0623,
Ms. Kathleen Cox, Associate Director,
Office of Permits and Air Toxics,
3AP10, U.S. Environmental Protection
Agency, Region III, 1650 Arch Street,
Philadelphia, Pennsylvania 19103.
4. 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–2011–
0623. EPA’s policy is that all comments
received 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 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 https://
www.regulations.gov or e-mail. The
https://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 e-mail comment directly
to EPA without going through https://
www.regulations.gov, your e-mail
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
DATES:
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Regulation
group(s)
1, 2, 3, 4, 5
3, 4, 5
3, 5
3, 4, 5
name and other contact information in
the body of your comment and with any
disk or CD–ROM you submit. 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: All documents in the
electronic docket are listed in the
https://www.regulations.gov index.
Although listed in the index, some
information is not publicly available,
i.e., CBI or other information whose
disclosure is restricted by statute.
Certain other material, such as
copyrighted material, is not placed on
the Internet and will be publicly
available only in hard copy form.
Publicly available docket materials are
available either electronically in https://
www.regulations.gov or in hard copy
during normal business hours at the Air
Protection Division, U.S. Environmental
Protection Agency, Region III, 1650
Arch Street, Philadelphia, Pennsylvania
19103. Copies of the State submittal are
available at the Maryland Department of
the Environment, 1800 Washington
Boulevard, Suite 705, Baltimore,
Maryland 21230.
FOR FURTHER INFORMATION CONTACT:
David Talley at 215–814–2117, or by
e-mail at talley.david@epa.gov.
SUPPLEMENTARY INFORMATION:
Throughout this document, whenever
‘‘we,’’ ‘‘us,’’ or ‘‘our’’ is used, we mean
EPA. EPA is proposing approval of this
SIP revision because it corrects the
deficiencies in the Maryland SIP and
eliminates inconsistencies between
State statutory and regulatory
requirements for preconstruction
permitting for electric generating
stations in Maryland. It will also ensure
that the SIP is adequate to prevent
significant deterioration of air quality in
areas designated as attainment or
unclassifiable as required by Sections
110(a) and 161 of the CAA and 40 CFR
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[Federal Register Volume 76, Number 150 (Thursday, August 4, 2011)]
[Proposed Rules]
[Pages 47089-47090]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-19808]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF THE INTERIOR
National Indian Gaming Commission
25 CFR Chapter III
Regulatory Review Schedule; Cancellation of Consultation Meetings
AGENCY: National Indian Gaming Commission.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: On November 18, 2010, the National Indian Gaming Commission
(NIGC) issued a Notice of Inquiry and Notice of Consultation advising
the public that the NIGC was conducting a comprehensive review of its
regulations and requesting public comment on the process for conducting
the regulatory review. On April 4, 2011, after holding eight
consultations and reviewing all comments, NIGC published a Notice of
Regulatory Review Schedule setting out a consultation schedule and
process for review. The purpose of this document is to cancel four
scheduled tribal consultations.
DATES: See SUPPLEMENTARY INFORMATION below for dates and locations of
cancelled consultations.
FOR FURTHER INFORMATION CONTACT: Lael Echo-Hawk, National Indian Gaming
Commission, 1441 L Street NW., Suite 9100 Washington, DC 20005.
Telephone: 202-632-7003; e-mail: reg.review@nigc.gov.
SUPPLEMENTARY INFORMATION: On November 18, 2010, the National Indian
Gaming Commission (NIGC) issued a Notice of Inquiry and Notice of
Consultation advising the public that it was conducting a review of its
regulations promulgated to implement 25 U.S.C. 2701-2721 of the Indian
Gaming Regulatory Act (IGRA) and requesting public comment on the
process for conducting the regulatory review. On April 4, 2011, after
holding eight consultations and reviewing all
[[Page 47090]]
comments, NIGC published a Notice of Regulatory Review Schedule in the
Federal Register setting out consultation schedules and review
processes. (76 FR 18457, April 4, 2011).
The Commission's regulatory review process establishes a tribal
consultation schedule with a description of the regulation groups to be
covered at each consultation. This document advises the public that the
following tribal consultations have been cancelled.
----------------------------------------------------------------------------------------------------------------
Regulation
Consultation date Event Location group(s)
----------------------------------------------------------------------------------------------------------------
August 25-26, 2011.................. NIGC Consultation-- Wild Horse Resort Casino, 1, 2, 3, 4, 5
Southwest. Scottsdale, AZ.
September 19-20, 2011............... NIGC Regional Training..... Sky Ute Casino Resort 3, 4, 5
Ignacio, CO.
September 27-28, 2011............... NIGC Consultation-- Turning Stone Casino, NY... 3, 5
Northeast.
November 7-12, 2011................. USET Annual Meeting........ Mississippi Choctaw, MS.... 3, 4, 5
----------------------------------------------------------------------------------------------------------------
For additional information on consultation locations and times,
please refer to the Web site of the National Indian Gaming Commission,
https://www.nigc.gov.
Dated: August 1, 2011, Washington, DC.
Tracie L. Stevens,
Chairwoman.
Steffani A. Cochran,
Vice-Chairwoman.
Daniel J. Little,
Associate Commissioner.
[FR Doc. 2011-19808 Filed 8-3-11; 8:45 am]
BILLING CODE P
