[Federal Register Volume 80, Number 154 (Tuesday, August 11, 2015)]
[Notices]
[Page 48098]
[FR Doc No: 2015-19689]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER15-2376-000]

Energy Power Investment Company, LLC; Supplemental Notice That
Initial Market-Based Rate Filing Includes Request for Blanket Section
204 Authorization

    This is a supplemental notice in the above-referenced proceeding of
Energy Power Investment Company, LLC's application for market-based
rate authority, with an accompanying rate tariff, noting that such
application includes a request for blanket authorization, under 18 CFR
part 34, of future issuances of securities and assumptions of
liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is August 25, 2015.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
5 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for electronic review in the
Commission's Public Reference Room in Washington, DC. There is an
eSubscription link on the Web site that enables subscribers to receive
email notification when a document is added to a subscribed docket(s).
For assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.

    Dated: August 5, 2015.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2015-19689 Filed 8-10-15; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 183 (Wednesday, September 21, 2011)]
[Notices]
[Pages 58490-58491]
[FR Doc No: 2011-24184]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER10-2283-001.
    Applicants: Midwest Independent Transmission System Operator, Inc.
    Description: Midwest Independent Transmission System Operator, Inc.
submits tariff filing per 35: 09-13-11 SECA to be effective 7/28/2010.
    Filed Date: 09/13/2011.
    Accession Number: 20110913-5113.
    Comment Date: 5 p.m. Eastern Time on Tuesday, October 04, 2011.

    Docket Numbers: ER11-4186-001.
    Applicants: Wolverine Power Supply Cooperative, Inc., Midwest
Independent Transmission System Operator, Inc.
    Description: Wolverine Power Supply Cooperative, Inc. submits
tariff filing per 35.17(b): Wolverine-Monterey Amendment to be
effective 1/14/2011.
    Filed Date: 09/13/2011.
    Accession Number: 20110913-5108.
    Comment Date: 5 p.m. Eastern Time on Tuesday, October 04, 2011.

    Docket Numbers: ER11-4510-000.
    Applicants: Pacific Power (Previously Pacificorp, PA)
    Description: PacifiCorp submits their Average System Cost filing
for sale of electric power to the Bonneville Power Administration for
Fiscal Year 2012-2013.
    Filed Date: 09/12/2011.
    Accession Number: 20110913-0201.
    Comment Date: 5 p.m. Eastern Time on Monday, October 03, 2011.

    Docket Numbers: ER11-4511-000.
    Applicants: Avista Corporation.
    Description: Avista Corp submits the Average System Cost filing for
sales of

electric power to the Bonneville Power Administration.
    Filed Date: 09/13/2011.
    Accession Number: 20110913-0202.
    Comment Date: 5 p.m. Eastern Time on Tuesday, October 04, 2011.

    Docket Numbers: ER11-4512-000.
    Applicants: California Independent System Operator Corporation.
    Description: California Independent System Operator Corporation
submits tariff filing per 35.13(a)(2)(iii: 2011-09-13 LGIA with CAISO,
SCE and NextEra to be effective 8/25/2011.
    Filed Date: 09/13/2011.
    Accession Number: 20110913-5091.
    Comment Date: 5 p.m. Eastern Time on Tuesday, October 04, 2011.

    Docket Numbers: ER11-4513-000.
    Applicants: PowerSmith Cogeneration Project, Limited Partnership.
    Description: PowerSmith Cogeneration Project, Limited Partnership
submits tariff filing per 35.1: PowerSmith Cogen Baseline MBR Tariff to
be effective 9/13/2011.
    Filed Date: 09/13/2011.
    Accession Number: 20110913-5109.
    Comment Date: 5 p.m. Eastern Time on Tuesday, October 04, 2011.

    Docket Numbers: ER11-4514-000.
    Applicants: Midwest Independent Transmission System Operator, Inc.
    Description: Midwest Independent Transmission System Operator, Inc.
submits tariff filing per 35.13(a)(2)(iii: 09-13-11 ATC Blackstart to
be effective 12/1/2011.
    Filed Date: 09/13/2011.
    Accession Number: 20110913-5110.
    Comment Date: 5 p.m. Eastern Time on Tuesday, October 04, 2011.

    Docket Numbers: ER11-4515-000.
    Applicants: Puget Sound Energy, Inc.
    Description: Puget Sound Energy, Inc. submits tariff filing per
35.12: Ferndale Pump Substation Interconnection Agreement to be
effective 10/1/2011.
    Filed Date: 09/13/2011.
    Accession Number: 20110913-5114.
    Comment Date: 5 p.m. Eastern Time on Tuesday, October 04, 2011.

    Take notice that the Commission received the following electric
securities filings:

    Docket Numbers: ES11-43-000.
    Applicants: El Paso Electric Company.
    Description: Application of El Paso Electric Company for
Authorization under section 204 of the Federal Power Act.
    Filed Date: 09/13/2011.
    Accession Number: 20110913-5148.
    Comment Date: 5 p.m. Eastern Time on Tuesday, October 04, 2011.

    Docket Numbers: ES11-44-000.
    Applicants: Georgia Power Company.
    Description: Application of Georgia Power Company.
    Filed Date: 09/13/2011.
    Accession Number: 20110913-5150.
    Comment Date: 5 p.m. Eastern Time on Tuesday, October 04, 2011.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: September 14, 2011.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2011-24184 Filed 9-20-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: September 6, 2007 (Volume 72, Number 172)]
[Proposed Rules]
[Page 51203-51204]
[DOCID:fr06se07-25]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2007-28601; Airspace Docket 07-AEA-02]

Proposed Establishment of Class D and E Airspace, Proposed
Revision of Class E Airspace; Easton, MD

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking.

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SUMMARY: This action proposes to establish Class D, E2 and E4 airspace
and revise E5 airspace at Easton, MD. A federal contract tower with a
weather reporting system is being constructed at Easton Airport/Newnam
Field. Therefore, the airport will meet criteria for Class D, E2, and
E4 surface area airspace. Class D surface area airspace and Class E4
airspace designed as an extension to Class D airspace is required when
the control tower is open to contain Standard Instrument Approach
Procedures (SIAPs) and other Instrument Flight Rules (IFR) operations
at the airport. Class E2 surface area airspace is required when the
control tower is closed to contain SIAPs and other IFR operations at
the airport. This action would establish Class D and E2 airspace
extending upward from the surface to and including 2,600 feet MSL
within a 4-mile radius of the airport and Class E4 airspace extension
that is 5.4 miles wide and extends 7.4 miles northeast of the Easton
Non Directional Beacon (NDB). Additionally, a technical revision to
Class E5 airspace is required as a result of a name change from the
Easton Municipal Airport to Easton Airport/Newnam Field, which was
effective May 25, 1993.

DATES: Comments must be received on or before October 22, 2007.

ADDRESSES: Send comments on this proposal to the Docket Management
System, U.S. Department of Transportation, Docket Operations, M-30,
1200 New Jersey Avenue, SE., West Building, Ground Floor, Room W12-140,
Washington, DC 20590; Telephone: 1-800-647-5527. You must identify the
docket number FAA-2007-28601; Airspace Docket No. 07-AEA-02, at the
beginning of your comments. You may also submit comments on the
Internet at http://dms.dot.gov. You may review the public docket

containing the proposal, any comments received, and any final
disposition in person in the Dockets Office (see ADDRESSES section for
address and phone number) between 9 a.m. and 5 p.m., Monday through
Friday, except Federal holidays.
    An informal docket may also be examined during normal business
hours at the office of the Eastern Service Center, Federal Aviation
Administration, Room C210, 1701 Columbia Avenue, College Park, Georgia
30337.

FOR FURTHER INFORMATION CONTACT: Mark D. Ward, Manager, System Support
Group, Eastern Service Center, Federal Aviation Administration. P.O.
Box 20636, Atlanta, Georgia 30320; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views or arguments as they
may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
Communications should identify both docket numbers and be submitted in
triplicate to the address listed above. Commenters wishing the FAA to
acknowledge receipt of their comments on this notice must submit with
those comments a self-addressed, stamped postcard on which the
following statement is made: ``Comments to Docket No. FAA-2007-28601;
Airspace Docket No. 07-AEA-02.'' The postcard will be date/time stamped
and returned to the commenter. All communications received before the
specified closing date for comments will be considered before taking
action on the proposed rule. The proposal contained in this notice may
be changed in light of the comments received. A report summarizing each
substantive public contact with FAA personnel concerned with this
rulemaking will be filed in the docket.

Availability of NPRMs

    An electronic copy of this document may be downloaded through the
Internet at http://dms.dot.gov Recently published rulemaking documents can also be accessed through the FAA's Web page at http://www.faa.gov.

or the Federal Register Web page at http://www.gpoaccess.gov/fr/index.html.
 Persons interested in being placed on mailing list for

future NPRM's should contact the FAA's Office of Rulemaking, (202) 267-
9677, to request a copy of

Advisory Circular No. 11-2A, Notice of Proposed Rulemaking Distribution
System, which describes the application procedure.

The Proposal

    The FAA is considering an amendment to Title 14 Code of Federal
Regulations, part 71 to establish Class D, E2, and E4 airspace and
revise Class E5 airspace at Easton, MD. Class D and E2 Airspace
Designations for Airspace Areas extending upward from the surface of
the Earth, Class E4 Airspace Areas Designated as an Extension to a
Class D Surface Area and Class E5 Airspace Areas extending upward from
700 feet ore more above the surface of the Earth are published in
Paragraphs 5000, 6002, 6004 and 6005 respectively of FAA Order 7400.9P,
dated September 1, 2006, and effective September 15, 2006, which is
incorporated by reference in 14 CFR 71.1 The Class D, E2, E4 and E5
airspace designations listed in this document would be published
subsequently in the Order.
    The FAA has determined that this proposed regulation only involves
an established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore, (1) is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a Regulatory Evaluation as the
anticipated impact is so minimal. Since this is a routine matter that
will only affect air traffic procedures and air navigation, it is
certified that this rule, when promulgated, will not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    In consideration of the foregoing, the Federal Aviation
Administration proposes to amend 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

    1. The authority citation for part 71 continues to read as follows:

    Authority: 49 U.S.C. 106(g); 40103, 40113, 40120; E.O. 10854, 24
FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

    2. The incorporation by reference in 14 CFR 71.1 of Federal
Aviation Administration Order 7400.9P, Airspace Designations and
Reporting Points, dated September 1, 2006, and effective September 15,
2006, is amended as follows:

Paragraph 5000 Class D Airspace.

* * * * *

AEA MD D Easton, MD [NEW]

Easton Airport/Newnam Field, MD
    (Lat. 38[deg]48'15'' N., long. 76[deg]04'08'' W.)

    That airspace extending upward from the surface to and including
2,600 feet MSL within a 4-mile radius of the Easton Airport/Newnam
Field. This Class D airspace area is effective during the specific
days and times established in advance by a Notice to Airmen. The
effective days and times will thereafter be continuously published
in the Airport/Facility Directory.
* * * * *

Paragraph 6002 Class E Airspace Designated as Surface Areas.

* * * * *

AEA MD E2 Easton, MD [NEW]

Easton Airport/Newman Field, MD
    (Lat. 38[deg]48'15'' N., long. 76[deg]04'08'' W.)
Easton NDB
    (Lat. 38[deg]48'17'' N., long. 76[deg]04'10'' W.)

    That airspace extending upward from the surface to and including
2,600 feet MSL within a 4-mile radius of the Easton Airport/Newman
Field and that airspace within 2.7 miles each side of the 038[deg]
bearing from the Easton NDB extending from the 4-mile radius of the
Easton Airport/Newman Field to 7.4 miles northeast of the NDB. This
Class E airspace area is effective during the specific days and
times established in advance by a Notice to Airmen. The effective
days and times will thereafter be continuously published in the
Airport/Facility Directory.
* * * * *

Paragraph 604 Class E Airspace Areas Designated as an Extension to
a Class D Surface Area.

* * * * *

AEA MD E4 Easton, MD [NEW]

Easton Airport/Newman Field, MD
    (Lat. 38[deg]48'15'' N., long. 76[deg]04'08'' W.)
Easton NDB
    (Lat. 38[deg]48'17'' N., long. 76[deg]04'10'' W.)

    That airspace extending upward from the surface within 2.7 miles
each side of the 038[deg] bearing from the Easton NDB extending from
the 4-mile radius of the Easton Airport/Newman Field to 7.4 miles
northeast of the NDB.
* * * * *

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
feet or More Above the Surface of the Earth.

* * * * *

AEA MD E5 Easton, MD [REVISED]

Easton Airport/Newman Field, MD
    (Lat. 38[deg]48'15'' N., long. 76[deg]04'08'' W.)
Easton NDB
    (Lat. 38[deg]48'17'' N., long. 76[deg]04'10'' W.)

    That airspace extending upward from 700 feet above the surface
within a 6.7-mile radius of the Easton Airport/Newman Field and
within 2.7 miles each side of the 038[deg] bearing from the Easton
NDB extending from the 6.7-mile radius to 7.4 miles northeast of the
NDB.

    Issued in College Park, Georgia, on August 8, 2007.
Kathy Kutch,
Acting Manager, System Support Group Eastern Service Center.

[FR Doc. 07-4330 Filed 9-5-07; 8:45 am]

BILLING CODE 4910-13-M


[Federal Register: May 16, 2006 (Volume 71, Number 94)]
[Notices]
[Page 28313]
[DOCID:fr16my06-60]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP96-200-152]

CenterPoint Energy Gas Transmission Company; Notice of Negotiated
Rate Filing

May 9, 2006.
    Take notice that on May 4, 2006, CenterPoint Energy Gas
Transmission Company (CEGT) tendered for filing as part of its FERC Gas
Tariff, Sixth Revised Volume No. 1, First Revised Sheet No. 820, to be
effective April 1, 2006.
    CEGT states that the purpose of this filing is to remove a
reference to a negotiated rate transaction which has been permanently
released.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed in accordance with the provisions of
Section 154.210 of the Commission's regulations (18 CFR 154.210).
Anyone filing an intervention or protest must serve a copy of that
document on the Applicant. Anyone filing an intervention or protest on
or before the intervention or protest date need not serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible online at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
[FR Doc. E6-7371 Filed 5-15-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 181 (Monday, September 19, 2011)]
[Notices]
[Page 58026]
[FR Doc No: 2011-23991]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-3329-EM; Docket ID FEMA-2011-0001]

Virginia; Amendment No. 2 to Notice of an Emergency Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: This notice amends the notice of an emergency declaration for
the Commonwealth of Virginia (FEMA-3329-EM), dated August 26, 2011, and
related determinations.

DATES: Effective Date: September 4, 2011.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street, SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that the incident
period for this emergency is closed effective September 4, 2011.

(The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households In
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050, Presidentially Declared Disaster
Assistance to Individuals and Households--Other Needs; 97.036,
Disaster Grants--Public Assistance (Presidentially Declared
Disasters); 97.039, Hazard Mitigation Grant.)

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2011-23991 Filed 9-16-11; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 81, Number 120 (Wednesday, June 22, 2016)]
[Notices]
[Pages 40690-40691]
[FR Doc No: 2016-14769]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER16-1924-000]

 Bison Solar LLC; Supplemental Notice That Initial Market-Based
Rate Filing Includes Request for Blanket Section 204 Authorization

    This is a supplemental notice in the above-referenced proceeding of
Bison Solar LLC`s application for market-based rate authority, with an
accompanying rate tariff, noting that such application includes a
request for blanket authorization, under 18 CFR part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard

to the applicant's request for blanket authorization, under 18 CFR part
34, of future issuances of securities and assumptions of liability, is
July 6, 2016.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
5 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for electronic review in the
Commission's Public Reference Room in Washington, DC. There is an
eSubscription link on the Web site that enables subscribers to receive
email notification when a document is added to a subscribed docket(s).
For assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For TTY,
call<PHONE_NUMBER>.

    Dated: June 16, 2016.
Kimberly D. Bose,
Secretary.
[FR Doc. 2016-14769 Filed 6-21-16; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register: May 25, 2011 (Volume 76, Number 101)]
[Notices]
[Page 30369]
[DOCID:fr25my11-87]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0622]

Agency Information Collection Activities; Announcement of Office
of Management and Budget Approval; Color Additive Certification
Requests and Recordkeeping

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing that a
collection of information entitled ``Color Additive Certification
Requests and Recordkeeping'' has been approved by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B,
Rockville, MD 20850,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In the Federal Register of February 24, 2011
(76 FR 10371), the Agency announced that the proposed information
collection had been submitted to OMB for review and clearance under 44
U.S.C. 3507. An Agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information unless it displays
a currently valid OMB control number. OMB has now approved the
information collection and has assigned OMB control number 0910-0216.
The approval expires on April 30, 2014. A copy of the supporting
statement for this information collection is available on the Internet
at http://www.reginfo.gov/public/do/PRAMain.

    Dated: May 19, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-12845 Filed 5-24-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 76, Number 81 (Wednesday, April 27, 2011)]
[Proposed Rules]
[Pages 23520-23522]
[FR Doc No: 2011-10131]

=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Chapter I

[Docket No. FDA-2011-N-0259]

Periodic Review of Existing Regulations; Retrospective Review
Under E.O. 13563

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification for request for comment.

-----------------------------------------------------------------------

SUMMARY: In accordance with Executive Order 13563, ``Improving
Regulation and Regulatory Review,'' the Food and Drug Administration
(FDA) is conducting a review of its existing regulations to determine,
in part, whether they can be made more effective in light of current
public health needs and to take advantage of and support advances in
innovation. The goal of this review of existing regulations, as with
our other reviews, is to help ensure that FDA's regulatory program is
more effective and less burdensome in achieving its regulatory
objectives. FDA is requesting comment and supporting data on which, if
any, of its existing rules are outmoded, ineffective, insufficient, or
excessively burdensome and thus may be good candidates to be modified,
streamlined, expanded, or repealed. As part of this review, FDA also
invites comment to help us review our framework for periodically
analyzing existing rules.

DATES: Submit either electronic or written comments by June 27, 2011.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2011-
N-0259, by any of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     Fax:<PHONE_NUMBER>.
     Mail/Hand delivery/Courier (for paper, disk, 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-2011-N-0259 for this rulemaking. All comments
received may

be posted without change to http://www.regulations.gov, including any
personal information provided. For additional information on submitting
comments, see the ``Request for 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 http://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: Lisa Helmanis, Office of Policy, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 3216,
Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: On February 2, 2011, President Barack Obama
issued Executive Order (E.O.) 13563, ``Improving Regulation and
Regulatory Review.'' One of the provisions in the new Executive order
is the affirmation of retrospective reviews of existing significant
regulations. FDA already has several processes in place to ensure
periodic review of its existing regulations, including those that are
significant, and will continue to enhance these efforts. Under E.O.
13563, FDA is reviewing this framework for retrospective review of
regulations and, through this notice, is soliciting comments on ways to
make this program more effective.

I. Background

    FDA is responsible for protecting the public health by: (1)
Ensuring the safety and efficacy of human and veterinary drugs,
biological products, and medical devices; (2) ensuring the safety and
security of our nation's food supply, products that emit radiation,
cosmetics; and (3) regulating the manufacture, marketing, and
distribution of tobacco products. FDA also promotes the public health
by striving to foster innovative approaches and solutions for some of
our nation's most compelling health and medical challenges.
    Currently, FDA has three main mechanisms that trigger a
retrospective review of an existing regulation. First, a retrospective
review may occur when there is a significant change in circumstances,
such as advances in technology, new data or other information, or
legislative change. Second, whenever FDA is revising an existing
regulation, it reviews that regulation to determine if the underlying
science and policy are still valid and whether the regulations should
be updated based on current science, policy, data, or technology. The
third mechanism is FDA's Citizen Petition process. Under 21 CFR 10.30,
FDA provides a mechanism for the public to request the Commissioner of
Food and Drugs to issue, amend, or revoke a regulation by submitting a
Citizen Petition.
    Other ongoing mechanisms that FDA uses to target specific audiences
are biannual letters to State and Local government officials and small
business entities, which are also posted on FDA's Web site. These
letters highlight upcoming regulations that FDA believes may have an
impact on these two groups. In addition, FDA uses the Federal
Government's biannual Unified Agenda of Federal Regulations (Unified
Agenda) to announce reviews conducted under section 610(c) of the
Regulatory Flexibility Act (RFA). In section 610(c), Federal Agencies
are required within 10 years of the effective date of regulations that
have a significant economic impact on a substantial number of small
entities to review the regulation and seek public input on the
continued need for the regulation or on possible changes to the
regulation.
    Since the 1980s, FDA has participated in a variety of reviews to
streamline and improve its regulatory processes. For example, as
previously mentioned, section 610(c) of the RFA requires Agencies to
review their regulations to determine whether the rules should be
continued without change, amended, or rescinded to minimize any
significant economic impact on a substantial number of small entities.
These reviews are announced in the Unified Agenda.
    In the 1990s, FDA participated in the ``Reinventing Government''
initiative and met 95 percent of its goal for eliminating outdated or
unnecessary regulations, and 89 percent of its goal for revising
regulations. Following that initiative, FDA has undertaken other
reviews of its regulations and regulatory processes including
implementing new efficiencies such as withdrawing outdated proposed
rules that were never finalized. The most recent withdrawal was in 2008
(73 FR 75625, December 12, 2008). We currently conduct this review of
pending proposed rules about every 5 years.
    Over the past 15 years, there have also been major legislative
changes that have significantly reformed major program areas within FDA
and added to the Agency's responsibilities. When FDA develops
implementing regulations for these legislative mandates, FDA also takes
the opportunity to modify or revoke related regulations as appropriate,
and streamline various regulatory processes.
    The Food and Drug Administration Modernization Act of 1997 and, 10
years later, the Food and Drug Administration Amendments Act of 2007
(FDAAA) both modernized certain FDA programs and created new ones,
mandating numerous regulations to implement those programs. FDAAA also
expanded FDA's user fee authority and charged FDA with encouraging more
research and development for treatments specifically for children. In
2009, FDA saw a significant increase in its authorities with enactment
of the Family Smoking Prevention and Tobacco Control Act of 2009.
Finally, earlier this year, the FDA Food Safety Modernization Act was
signed into law by President Obama and, when fully implemented, will
enable FDA to better protect public health by helping to ensure the
safety and security of the food supply.

II. Request for Comments

    FDA is first seeking comment on how the Agency could revise its
existing review framework to meet the objectives of E.O. 13563
regarding the development of a plan with a defined method and schedule
for identifying certain significant rules that may be obsolete,
unnecessary, unjustified, excessively burdensome, or counterproductive.
Comments should address how best to evaluate and analyze regulations to
expand on those that work and to modify, improve, or rescind those that
do not. To be useful, comments should address how FDA can best obtain
and consider accurate, objective information and data about the costs,
burdens, and benefits of existing regulations and whether there are
existing sources of data that FDA can use to evaluate the post-
promulgation effects of regulations over time. FDA is particularly
interested in how well its current processes for reviewing regulations
function and how those processes might be expanded or otherwise adapted
to meet the objectives of E.O. 13563. FDA is further interested in
comments about factors that it should consider in selecting rules for
review and prioritizing review.
    Due to limited resources, FDA generally focuses its retrospective
review efforts on: (1) Regulations that have a significant public
health impact, (2) regulations that impose a significant burden on the
Agency and/or industry, and (3) regulations that impose no significant
burden on the Agency and/or industry. FDA welcomes comments

on other criteria it should be using when prioritizing its reviews of
existing significant regulations.
    In addition, FDA is seeking public comment on which, if any,
regulations should be reviewed at this time. Please identify any
regulation that should be modified, expanded, streamlined, or repealed
to make our regulatory program more effective and less burdensome.
Please be as specific as possible in your comments. To support its
efforts to support innovation, FDA is particularly interested in
comments that identify regulations that may be impediments to
innovation and suggestions for how they can be improved.
    Comments should focus on regulations that have demonstrated
deficiencies. Comments that reiterate previously submitted arguments
relating to recently issued rules will be less useful. Furthermore, the
public should focus on rule changes that will achieve a broad public
impact, rather than an individual personal or corporate benefit.
Comments should reference a specific regulation by the Code of Federal
Regulations (CFR) cite, and provide specific information on what needs
fixing and why. Lastly, FDA stresses that this review is for published
final rules; the public should not use this process to submit comments
on proposed rules.
    The most useful comments will include which specific regulations
need to be changed, strengthened or clarified, or revoked. It will be
most helpful to include the specific reasons explaining why the change
or revocation is necessary or desired, and to provide specific ways to
improve the regulation, particularly any specific language
modifications.
    The Agency will be able to more efficiently review and consider
comments that are submitted in the format shown in table 1 of this
document:

                 Table 1--Format for Submitting Comments
------------------------------------------------------------------------
           Name of regulation
------------------------------------------------------------------------
Type of Product or FDA Center            ...............................
 Regulating the Product.
Statute or Code of Federal Regulations   ...............................
 cite (if known).
Brief Description of Problem...........  (For example, is it outmoded,
                                          ineffective, insufficient, or
                                          excessively burdensome? Why?)
Available Data on Cost or Economic       (Quantified benefits and cost
 Impact.                                  if possible. Qualitative
                                          description, if needed.)
Proposed Solution......................  (Include the fix and procedure
                                          to solve it. For example, what
                                          would be the best way to
                                          modify, streamline, expand, or
                                          repeal the regulation?)
------------------------------------------------------------------------

    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.

    Dated: April 20, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-10131 Filed 4-26-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 77, Number 12 (Thursday, January 19, 2012)]
[Rules and Regulations]
[Pages 2646-2650]
[FR Doc No: 2012-929]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

44 CFR Part 64

[Docket ID FEMA-2011-0002; Internal Agency Docket No. FEMA-8213]

Suspension of Community Eligibility

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This rule identifies communities where the sale of flood
insurance has been authorized under the National Flood Insurance
Program (NFIP) that are scheduled for suspension on the effective dates
listed within this rule because of noncompliance with the floodplain
management requirements of the program. If the Federal Emergency
Management Agency (FEMA) receives documentation that the community has
adopted the required floodplain management measures prior to the
effective suspension date given in this rule, the suspension will not
occur and a notice of this will be provided by publication in the
Federal Register on a subsequent date.

DATES: Effective Dates: The effective date of each community's
scheduled suspension is the third date (``Susp.'') listed in the third
column of the following tables.

FOR FURTHER INFORMATION CONTACT: If you want to determine whether a
particular community was suspended on the suspension date or for
further information, contact David Stearrett, Mitigation Directorate,
Federal Emergency Management Agency, 500 C Street SW., Washington, DC
20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The NFIP enables property owners to purchase
Federal flood insurance that is not otherwise generally available from
private insurers. In return, communities agree to adopt and administer
local floodplain management aimed at protecting lives and new
construction from future flooding. Section 1315 of the National Flood
Insurance Act of 1968, as amended, 42 U.S.C. 4022, prohibits the sale
of NFIP flood insurance unless an appropriate public body adopts
adequate floodplain management measures with effective enforcement
measures. The communities listed in this document no longer meet that
statutory requirement for compliance with program regulations, 44 CFR
part 59. Accordingly, the communities will be suspended on the
effective date in the third column. As of that date, flood insurance
will no longer be available in the community. We recognize that some of
these communities may adopt and submit the required documentation of
legally enforceable floodplain management measures after this rule is
published but prior to the actual suspension date. These communities
will not be suspended and will continue their eligibility for the sale
of insurance. A notice withdrawing the suspension of the communities
will be published in the Federal Register.
    In addition, FEMA publishes a Flood Insurance Rate Map (FIRM) that
identifies the Special Flood Hazard Areas (SFHAs) in these communities.
The date of the FIRM, if one has been published, is indicated in the
fourth column of the table. No direct Federal financial assistance
(except assistance pursuant to the Robert T. Stafford Disaster Relief
and Emergency Assistance Act not in connection with a flood) may be
provided for construction or acquisition of buildings in identified
SFHAs for communities not participating in the NFIP and identified for
more than a year on FEMA's initial FIRM for the community as having
flood-prone areas (section 202(a) of the Flood Disaster Protection Act
of 1973, 42 U.S.C. 4106(a), as amended). This prohibition against
certain types of Federal assistance becomes effective for the
communities listed on the date shown in the last column. The
Administrator finds that notice and public comment under 5 U.S.C.
553(b) are impracticable and unnecessary because communities listed in
this final rule have been adequately notified.
    Each community receives 6-month, 90-day, and 30-day notification
letters addressed to the Chief Executive Officer stating that the
community will be suspended unless the required floodplain management
measures are met prior to the effective suspension date. Since these
notifications were made, this final rule may take effect within less
than 30 days.
    National Environmental Policy Act. This rule is categorically
excluded from the requirements of 44 CFR part 10, Environmental
Considerations. No environmental impact assessment has been prepared.
    Regulatory Flexibility Act. The Administrator has determined that
this rule is exempt from the requirements of the Regulatory Flexibility
Act because the National Flood Insurance Act of 1968, as amended, 42
U.S.C. 4022, prohibits flood insurance coverage unless an appropriate
public body adopts adequate floodplain management measures with
effective enforcement measures. The communities listed no longer comply
with the statutory requirements, and after the effective date, flood
insurance will no longer be available in the communities unless
remedial action takes place.
    Regulatory Classification. This final rule is not a significant
regulatory action under the criteria of section 3(f) of Executive Order
12866 of September 30, 1993, Regulatory Planning and Review, 58 FR
51735.
    Executive Order 13132, Federalism. This rule involves no policies
that have federalism implications under Executive Order 13132.
    Executive Order 12988, Civil Justice Reform. This rule meets the
applicable standards of Executive Order 12988.

    Paperwork Reduction Act. This rule does not involve any collection
of information for purposes of the Paperwork Reduction Act, 44 U.S.C.
3501 et seq.

List of Subjects in 44 CFR Part 64

    Flood insurance, Floodplains.

    Accordingly, 44 CFR part 64 is amended as follows:

PART 64--[AMENDED]

0
1. The authority citation for part 64 continues to read as follows:

    Authority:  42 U.S.C. 4001 et seq.; Reorganization Plan No. 3 of
1978, 3 CFR, 1978 Comp.; p. 329; E.O. 12127, 44 FR 19367, 3 CFR,
1979 Comp.; p. 376.

Sec.  64.6  [Amended]

0
2. The tables published under the authority of Sec.  64.6 are amended
as follows:

----------------------------------------------------------------------------------------------------------------
                                                Effective date
                                                authorization/
                                  Community     cancellation of    Current effective map   Date certain Federal
      State and location             No.         sale of flood             date            assistance no longer
                                                 insurance in                               available in SFHAs
                                                   community
----------------------------------------------------------------------------------------------------------------
          Region III

Pennsylvania:
    Antrim, Township of,              421233  March 26, 1974,     Jan. 18, 2012.........  Jan. 18, 2012.
     Franklin County.                          Emerg; April 24,
                                               1981, Reg;
                                               January 18, 2012,
                                               Susp.
    Benezette, Township of,           422612  August 8, 1979,     ......do..............   Do.
     Elk County.                               Emerg; June 1,
                                               1987, Reg;
                                               January 18, 2012,
                                               Susp.
    Bessemer, Borough of,             422627  August 1, 1975,     ......do..............   Do.
     Lawrence County.                          Emerg; July 9,
                                               1982, Reg;
                                               January 18, 2012,
                                               Susp.
    Chambersburg, Borough of,         420469  February 2, 1973,   ......do..............   Do.
     Franklin County.                          Emerg; July 17,
                                               1978, Reg;
                                               January 18, 2012,
                                               Susp.
    Ellport, Borough of,              422462  March 9, 1976,      ......do..............   Do.
     Lawrence County.                          Emerg; November
                                               17, 1978, Reg;
                                               January 18, 2012,
                                               Susp.
    Ellwood City, Borough of,         420567  October 3, 1974,    ......do..............   Do.
     Lawrence County.                          Emerg; June 1,
                                               1982, Reg;
                                               January 18, 2012,
                                               Susp.
    Enon Valley, Borough of,          422463  August 11, 1975,    ......do..............   Do.
     Lawrence County.                          Emerg; August 3,
                                               1984, Reg;
                                               January 18, 2012,
                                               Susp.
    Fannett, Township of,             422424  February 13, 1976,  ......do..............   Do.
     Franklin County.                          Emerg; October
                                               29, 1982, Reg;
                                               January 18, 2012,
                                               Susp.
    Fox, Township of, Elk             421608  December 19, 1975,  ......do*.............   Do.
     County.                                   Emerg; November
                                               2, 1990, Reg;
                                               January 18, 2012,
                                               Susp.
    Greencastle, Borough of,          420470  April 24, 1975,     ......do..............   Do.
     Franklin County.                          Emerg; September
                                               30, 1976, Reg;
                                               January 18, 2012,
                                               Susp.
    Greene, Township of,              421649  June 18, 1974,      ......do..............   Do.
     Franklin County.                          Emerg; November
                                               2, 1990, Reg;
                                               January 18, 2012,
                                               Susp.
    Guilford, Township of,            421650  January 20, 1976,   ......do..............   Do.
     Franklin County.                          Emerg; June 18,
                                               1990, Reg;
                                               January 18, 2012,
                                               Susp.
    Hamilton, Township of,            421651  September 17,       ......do..............   Do.
     Franklin County.                          1974, Emerg; June
                                               18, 1990, Reg;
                                               January 18, 2012,
                                               Susp.
    Hickory, Township of,             421792  April 7, 1975,      ......do..............   Do.
     Lawrence County.                          Emerg; August 2,
                                               1982, Reg;
                                               January 18, 2012,
                                               Susp.
    Highland, Township of, Elk        421609  January 29, 1976,   ......do..............   Do.
     County.                                   Emerg; December
                                               1, 1986, Reg;
                                               January 18, 2012,
                                               Susp.
    Horton, Township of, Elk          421610  June 12, 1980,      ......do..............   Do.
     County.                                   Emerg; December
                                               1, 1986, Reg;
                                               January 18, 2012,
                                               Susp.
    Jay, Township of, Elk             421611  January 13, 1976,   ......do..............   Do.
     County.                                   Emerg; December
                                               1, 1986, Reg;
                                               January 18, 2012,
                                               Susp.
    Johnsonburg, Borough of,          420443  February 2, 1973,   ......do..............   Do.
     Elk County.                               Emerg; September
                                               29, 1978, Reg;
                                               January 18, 2012,
                                               Susp.
    Jones, Township of, Elk           421612  January 27, 1976,   ......do..............   Do.
     County.                                   Emerg; December
                                               1, 1986, Reg;
                                               January 18, 2012,
                                               Susp.
    Letterkenny, Township of,         422425  April 30, 1979,     ......do..............   Do.
     Franklin County.                          Emerg; September
                                               17, 1982, Reg;
                                               January 18, 2012,
                                               Susp.
    Little Beaver, Township           422464  December 22, 1975,  ......do..............   Do.
     of, Lawrence County.                      Emerg; May 1,
                                               1986, Reg;
                                               January 18, 2012,
                                               Susp.
    Lurgan, Township of,              421652  October 28, 1975,   ......do..............   Do.
     Franklin County.                          Emerg; September
                                               1, 1978, Reg;
                                               January 18, 2012,
                                               Susp.
    Mahoning, Township of,            421793  April 29, 1975,     ......do..............   Do.
     Lawrence County.                          Emerg; February
                                               18, 1983, Reg;
                                               January 18, 2012,
                                               Susp.
    Mercersburg, Borough of,          420471  August 6, 1975,     ......do..............   Do.
     Franklin County.                          Emerg; March 1,
                                               1986, Reg;
                                               January 18, 2012,
                                               Susp.
    Metal, Township of,               421653  January 16, 1976,   ......do..............   Do.
     Franklin County.                          Emerg; September
                                               1, 1986, Reg;
                                               January 18, 2012,
                                               Susp.
    Millstone, Township of,           421613  March 8, 1977,      ......do..............   Do.
     Elk County.                               Emerg; December
                                               1, 1986, Reg;
                                               January 18, 2012,
                                               Susp.
    Mont Alto, Borough of,            420472  July 9, 1975,       ......do..............   Do.
     Franklin County.                          Emerg; July 16,
                                               1990, Reg;
                                               January 18, 2012,
                                               Susp.
    Montgomery, Township of,          422426  August 1, 1979,     ......do..............   Do.
     Franklin County.                          Emerg; August 1,
                                               1986, Reg;
                                               January 18, 2012,
                                               Susp.

    Neshannock, Township of,          421794  November 22, 1974,  ......do..............   Do.
     Lawrence County.                          Emerg; May 17,
                                               1982, Reg;
                                               January 18, 2012,
                                               Susp.
    New Castle, City of,              420568  August 31, 1973,    ......do..............   Do.
     Lawrence County.                          Emerg; August 15,
                                               1978, Reg;
                                               January 18, 2012,
                                               Susp.
    New Wilmington, Borough           420569  November 8, 1974,   ......do..............   Do.
     of, Lawrence County.                      Emerg; August 3,
                                               1984, Reg;
                                               January 18, 2012,
                                               Susp.
    North Beaver, Township of,        421795  March 2, 1977,      ......do..............   Do.
     Lawrence County.                          Emerg; August 19,
                                               1987, Reg;
                                               January 18, 2012,
                                               Susp.
    Peters, Township of,              421654  August 14, 1975,    ......do..............   Do.
     Franklin County.                          Emerg; September
                                               1, 1986, Reg;
                                               January 18, 2012,
                                               Susp.
    Plain Grove, Township of,         421797  August 1, 1979,     ......do..............   Do.
     Lawrence County.                          Emerg; August 3,
                                               1984, Reg;
                                               January 18, 2012,
                                               Susp.
    Pulaski, Township of,             421798  October 21, 1974,   ......do..............   Do.
     Lawrence County.                          Emerg; December
                                               31, 1982, Reg;
                                               January 18, 2012,
                                               Susp.
    Quincy, Township of,              421655  September 27,       ......do..............   Do.
     Franklin County.                          1982, Emerg; July
                                               16, 1990, Reg;
                                               January 18, 2012,
                                               Susp.
    Ridgway, Borough of, Elk          420444  September 1, 1972,  ......do..............   Do.
     County.                                   Emerg; February
                                               15, 1980, Reg;
                                               January 18, 2012,
                                               Susp.
    Ridgway, Township of, Elk         420445  May 15, 1973,       ......do..............   Do.
     County.                                   Emerg; September
                                               29, 1978, Reg;
                                               January 18, 2012,
                                               Susp.
    Scott, Township of,               421799  July 23, 1974,      ......do..............   Do.
     Lawrence County.                          Emerg; November
                                               1, 1986, Reg;
                                               January 18, 2012,
                                               Susp.
    Shenango, Township of,            421029  January 28, 1974,   ......do..............   Do.
     Lawrence County.                          Emerg; April 3,
                                               1978, Reg;
                                               January 18, 2012,
                                               Susp.
    Slippery Rock, Township           422466  March 1, 1977,      ......do..............   Do.
     of, Lawrence County.                      Emerg; November
                                               1, 1986, Reg;
                                               January 18, 2012,
                                               Susp.
    South New Castle, Borough         422467  February 18, 1976,  ......do..............   Do.
     of, Lawrence County.                      Emerg; July 31,
                                               1978, Reg;
                                               January 18, 2012,
                                               Susp.
    Southampton, Township of,         421657  June 17, 1975,      ......do..............   Do.
     Franklin County.                          Emerg; May 15,
                                               1986, Reg;
                                               January 18, 2012,
                                               Susp.
    Spring Creek, Township of,        421614  March 8, 1977,      ......do..............   Do.
     Elk County.                               Emerg; December
                                               1, 1986, Reg;
                                               January 18, 2012,
                                               Susp.
    St. Marys, City of, Elk           420446  October 25, 1973,   ......do..............   Do.
     County.                                   Emerg; August 15,
                                               1980, Reg;
                                               January 18, 2012,
                                               Susp.
    St. Thomas, Township of,          421656  August 15, 1975,    ......do..............   Do.
     Franklin County.                          Emerg; July 16,
                                               1990, Reg;
                                               January 18, 2012,
                                               Susp.
    Taylor, Township of,              421800  July 30, 1975,      ......do..............   Do.
     Lawrence County.                          Emerg; August 3,
                                               1984, Reg;
                                               January 18, 2012,
                                               Susp.
    Union, Township of,               421801  April 21, 1975,     ......do..............   Do.
     Lawrence County.                          Emerg; November
                                               5, 1982, Reg;
                                               January 18, 2012,
                                               Susp.
    Volant, Borough of,               421790  July 23, 1975,      ......do..............   Do.
     Lawrence County.                          Emerg; September
                                               28, 1979, Reg;
                                               January 18, 2012,
                                               Susp.
    Wampum, Borough of,               421791  December 26, 1974,  ......do..............   Do.
     Lawrence County.                          Emerg; August 3,
                                               1984, Reg;
                                               January 18, 2012,
                                               Susp.
    Warren, Township of,              422427  February 17, 1976,  ......do..............   Do.
     Franklin County.                          Emerg; September
                                               1, 1986, Reg;
                                               January 18, 2012,
                                               Susp.
    Washington, Township of,          421658  July 1, 1975,       ......do..............   Do.
     Franklin County.                          Emerg; June 3,
                                               1986, Reg;
                                               January 18, 2012,
                                               Susp.
    Washington, Township of,          422468  April 3, 1979,      ......do..............   Do.
     Lawrence County.                          Emerg; September
                                               24, 1984, Reg;
                                               January 18, 2012,
                                               Susp.
    Wayne, Township of,               422469  June 27, 1975,      ......do..............   Do.
     Lawrence County.                          Emerg; May 3,
                                               1982, Reg;
                                               January 18, 2012,
                                               Susp.
    Waynesboro, Borough of,           420473  May 4, 1973,        ......do..............   Do.
     Franklin County.                          Emerg; November
                                               1, 1985, Reg;
                                               January 18, 2012,
                                               Susp.
    Wilmington, Township of,          421802  August 12, 1974,    ......do..............   Do.
     Lawrence County.                          Emerg; June 1,
                                               1986, Reg;
                                               January 18, 2012,
                                               Susp.

           Region IV

Mississippi:
    Doddsville, Town of,              280162  April 15, 1975,     ......do..............   Do.
     Sunflower County.                         Emerg; July 17,
                                               1986, Reg;
                                               January 18, 2012,
                                               Susp.
    Drew, City of, Sunflower          280163  June 5, 1973,       ......do..............   Do.
     County.                                   Emerg; May 1,
                                               1978, Reg;
                                               January 18, 2012,
                                               Susp.
    Durant, City of, Holmes           280074  April 1, 1974,      ......do..............   Do.
     County.                                   Emerg; August 19,
                                               1986, Reg;
                                               January 18, 2012,
                                               Susp.
    Holmes County,                    280211  April 11, 1974,     ......do..............   Do.
     Unincorporated Areas.                     Emerg; September
                                               15, 1989, Reg;
                                               January 18, 2012,
                                               Susp.
    Moorhead, City of,                280166  May 24, 1973,       ......do..............   Do.
     Sunflower County.                         Emerg; April 17,
                                               1978, Reg;
                                               January 18, 2012,
                                               Susp.
    Ruleville, Town of,               280167  May 14, 1973,       ......do..............   Do.
     Sunflower County.                         Emerg; May 1,
                                               1978, Reg;
                                               January 18, 2012,
                                               Susp.

    Sunflower, Town of,               280168  May 14, 1973,       ......do..............   Do.
     Sunflower County.                         Emerg; July 17,
                                               1978, Reg;
                                               January 18, 2012,
                                               Susp.
    Sunflower County,                 280195  May 4, 1973,        ......do..............   Do.
     Unincorporated Areas.                     Emerg; September
                                               28, 1979, Reg;
                                               January 18, 2012,
                                               Susp.

           Region V

Indiana:
    Boone County,                     180011  November 26, 1975,  ......do..............   Do.
     Unincorporated Areas.                     Emerg; September
                                               16, 1982, Reg;
                                               January 18, 2012,
                                               Susp.
    Cedar Lake, Town of, Lake         180127  July 25, 1975,      ......do..............   Do.
     County.                                   Emerg; March 15,
                                               1982, Reg;
                                               January 18, 2012,
                                               Susp.
    Crown Point, City of, Lake        180128  January 31, 1975,   ......do..............   Do.
     County.                                   Emerg; March 18,
                                               1980, Reg;
                                               January 18, 2012,
                                               Susp.
    Dyer, Town of, Lake County        180129  October 10, 1974,   ......do..............   Do.
                                               Emerg; May 15,
                                               1984, Reg;
                                               January 18, 2012,
                                               Susp.
    East Chicago, City of,            180130  February 26, 1975,  ......do..............   Do.
     Lake County.                              Emerg; June 4,
                                               1980, Reg;
                                               January 18, 2012,
                                               Susp.
    Gary, City of, Lake County        180132  March 17, 1975,     ......do..............   Do.
                                               Emerg; March 16,
                                               1981, Reg;
                                               January 18, 2012,
                                               Susp.
    Griffith, Town of, Lake           185175  February 26, 1971,  ......do..............   Do.
     County.                                   Emerg; April 14,
                                               1972, Reg;
                                               January 18, 2012,
                                               Susp.
    Hammond, City of, Lake            180134  December 10, 1974,  ......do..............   Do.
     County.                                   Emerg; March 16,
                                               1981, Reg;
                                               January 18, 2012,
                                               Susp.
    Highland, Town of, Lake           185176  May 21, 1971,       ......do..............   Do.
     County.                                   Emerg; May 19,
                                               1972, Reg;
                                               January 18, 2012,
                                               Susp.
    Hobart, City of, Lake             180136  February 14, 1975,  ......do..............   Do.
     County.                                   Emerg; December
                                               4, 1979, Reg;
                                               January 18, 2012,
                                               Susp.
    Lake County,                      180126  July 25, 1973,      ......do..............   Do.
     Unincorporated Areas.                     Emerg; September
                                               2, 1981, Reg;
                                               January 18, 2012,
                                               Susp.
    Lake Station, City of,            180131  March 27, 1975,     ......do..............   Do.
     Lake County.                              Emerg; September
                                               5, 1979, Reg;
                                               January 18, 2012,
                                               Susp.
    Lebanon, City of, Boone           180013  June 25, 1975,      ......do..............   Do.
     County.                                   Emerg; May 3,
                                               1982, Reg;
                                               January 18, 2012,
                                               Susp.
    Lowell, Town of, Lake             180137  January 31, 1975,   ......do..............   Do.
     County.                                   Emerg; December
                                               4, 1979, Reg;
                                               January 18, 2012,
                                               Susp.
    Merrillville, Town of,            180138  February 16, 1973,  ......do..............   Do.
     Lake County.                              Emerg; October
                                               15, 1981, Reg;
                                               January 18, 2012,
                                               Susp.
    Munster, Town of, Lake            180139  November 11, 1974,  ......do..............   Do.
     County.                                   Emerg; May 16,
                                               1983, Reg;
                                               January 18, 2012,
                                               Susp.
    New Chicago, Town of, Lake        180140  March 13, 1975,     ......do..............   Do.
     County.                                   Emerg; January 2,
                                               1980, Reg;
                                               January 18, 2012,
                                               Susp.
    Schererville, Town of,            180142  March 17, 1975,     ......do..............   Do.
     Lake County.                              Emerg; May 1,
                                               1980, Reg;
                                               January 18, 2012,
                                               Susp.
    Schneider, Town of, Lake          180143  March 3, 1976,      ......do..............   Do.
     County.                                   Emerg; August 1,
                                               1980, Reg;
                                               January 18, 2012,
                                               Susp.
    St. John, Town of, Lake           180141  January 20, 1975,   ......do..............   Do.
     County.                                   Emerg; November
                                               1, 1979, Reg;
                                               January 18, 2012,
                                               Susp.
    Thorntown, Town of, Boone         180014  April 29, 1975,     ......do..............   Do.
     County.                                   Emerg; July 21,
                                               1978, Reg;
                                               January 18, 2012,
                                               Susp.
    Whitestown, Town of, Boone        180015  August 5, 1975,     ......do..............   Do.
     County.                                   Emerg; April 5,
                                               1988, Reg;
                                               January 18, 2012,
                                               Susp.
    Whiting, City of, Lake            180313  March 9, 1977,      ......do..............   Do.
     County.                                   Emerg; March 6,
                                               1981, Reg;
                                               January 18, 2012,
                                               Susp.
    Winfield, Town of, Lake           180515  N/A, Emerg;         ......do..............   Do.
     County.                                   November 14,
                                               1997, Reg;
                                               January 18, 2012,
                                               Susp.
    Zionsville, Town of, Boone        180016  May 2, 1975,        ......do..............   Do.
     County.                                   Emerg; December
                                               15, 1981, Reg;
                                               January 18, 2012,
                                               Susp.
    Michigan: Higgins,                261011  December 22, 1997,  ......do..............   Do.
     Township of, Roscommon                    Emerg; N/A, Reg;
     County.                                   January 18, 2012,
                                               Susp.

           Region VI

Oklahoma:
    Mooreland, Town of,               400230  August 16, 1974,    ......do..............   Do.
     Woodward County.                          Emerg; June 19,
                                               1985, Reg;
                                               January 18, 2012,
                                               Susp.
    Woodward, City of,                400232  April 30, 1974,     ......do..............   Do.
     Woodward County.                          Emerg; December
                                               16, 1980, Reg;
                                               January 18, 2012,
                                               Susp.
    Woodward County,                  400500  June 29, 1990,      ......do..............   Do.
     Unincorporated Areas.                     Emerg; January
                                               17, 1997, Reg;
                                               January 18, 2012,
                                               Susp.
----------------------------------------------------------------------------------------------------------------
*do = Ditto.
Code for reading third column: Emerg.--Emergency; Reg.--Regular; Susp.--Suspension.

    Dated: January 12, 2012.
David L. Miller,
Associate Administrator, Federal Insurance and Mitigation
Administration, Department of Homeland Security, Federal Emergency
Management Agency.
[FR Doc. 2012-929 Filed 1-18-12; 8:45 am]
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[Federal Register Volume 88, Number 109 (Wednesday, June 7, 2023)]
[Notices]
[Pages 37257-37259]
[FR Doc No: 2023-12099]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-D-1955]

E6(R3) Guideline for Good Clinical Practice; International
Council for Harmonisation; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``E6(R3)
Guideline for Good Clinical Practice.'' The draft guidance was prepared
under the auspices of the International Council for Harmonisation of
Technical Requirements for Pharmaceuticals for Human Use (ICH). The
draft guidance outlines modernized Good Clinical Practice
considerations to guide thoughtful design and responsible conduct of
clinical trials in a manner that ensures participant safety and the
reliability of trial results. This draft guidance encourages
innovation, focuses on quality, and establishes proportionate and risk-
based approaches for conducting clinical trials, while minimizing
unnecessary complexities. The draft guidance is intended to provide
flexible, modern, and clear Good Clinical Practice for conducting
clinical trials.

DATES: Submit either electronic or written comments on the draft
guidance by September 5, 2023 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2023-D-1955 for ``E6(R3) Guideline for Good Clinical Practice.''
Received comments will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper 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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002, or the
Office of Communication, Outreach and Development, Center for Biologics
Evaluation and Research, 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 that office in processing
your requests. The guidance may also be obtained by mail by calling
Center for Biologics Evaluation and Research at<PHONE_NUMBER> or 240-
402-8010. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT:
    Regarding the guidance: Amy Chi, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6334, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
[email protected]; or Diane Maloney, Center for Biologics Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
[email protected].
    Regarding the ICH: Jill Adleberg, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6364, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``E6(R3) Guideline for Good Clinical Practice.'' The draft
guidance was prepared under the auspices of ICH. ICH seeks to achieve
greater regulatory harmonization worldwide to ensure that safe,
effective, high-quality medicines are developed, registered, and
maintained in the most resource-efficient manner.
    By harmonizing the regulatory requirements in regions around the
world, ICH guidelines enhance global drug development, improve
manufacturing standards, and increase the availability of medications.
For example, ICH guidelines have substantially reduced duplicative
clinical studies, prevented unnecessary animal studies, standardized
the reporting of important safety information, and standardized
marketing application submissions.
    The six Founding Members of the ICH are FDA; the Pharmaceutical
Research and Manufacturers of America; the European Commission; the
European Federation of Pharmaceutical Industries Associations; the
Japanese Ministry of Health, Labour, and Welfare; and the Japanese
Pharmaceutical Manufacturers Association. The Standing Members of the
ICH Association include Health Canada and Swissmedic. ICH membership
continues to expand to include other regulatory authorities and
industry associations from around the world (refer to https://www.ich.org/).
    ICH works by engaging global regulatory and industry experts in a
detailed, science-based, and consensus-driven process that results in
the development of ICH guidelines. The regulators around the world are
committed to consistently adopting these consensus-based guidelines,
realizing the benefits for patients and for industry.
    As a Founding Regulatory Member of ICH, FDA plays a major role in
the development of each of the ICH guidelines, which FDA then adopts
and issues as guidance for industry. FDA's guidance documents do not
establish legally enforceable responsibilities. Instead, they describe
the Agency's current thinking on a topic and should be viewed only as
recommendations, unless specific regulatory or statutory requirements
are cited.
    In May 2023, the ICH Assembly endorsed the draft guideline entitled
``E6(R3) Guideline for Good Clinical Practice'' and agreed that the
guideline should be made available for public comment. The draft
guideline is the product of the Efficacy Expert Working Group of the
ICH. Comments about this draft will be considered by FDA and the
Efficacy Expert Working Group.
    The draft guidance on Good Clinical Practice is intended to support
the responsible conduct of clinical trials in a manner that safeguards
participant safety and the reliability of trial results. This guidance
facilitates the use of innovations and encourages a focus on the
important aspects in trial, while minimizing unnecessary complexities.
    This draft guidance has been left in the original ICH format. The
final guidance will be reformatted and edited to conform with FDA's
good guidance practices regulation (21 CFR 10.115) and style before
publication. The draft guidance, when finalized, will represent the
current thinking of FDA on ``E6(R3) Guideline for Good Clinical
Practice.'' It does not establish any rights for any person and is not
binding on FDA or the public. You can use an alternative approach if it
satisfies the requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information found in 21 CFR part 312 for investigational new drug
applications have been approved under OMB control number 0910-0014. The
collections of information under 21 CFR part 312.145 pertaining to good
clinical practice have been approved under OMB control number 0910-
0843. The collections of information found in 21 CFR parts 50 and 56
pertaining to protection of human subjects, institutional review boards
and informed consent have been approved under OMB control number 0910-
0130. The collections of information found in 21 CFR part 314 relating
to the review of new drug applications have been approved under OMB
control number 0910-0001. The collections of information found in 21
CFR part 601 relating to the review of biologic licensing applications
have been approved under OMB control number 0910-0338. The collections
of information found in 21 CFR part 11 pertaining to electronic records
and electronic signatures have been approved under OMB control number
0910-0303. The collections of information found in 21 CFR parts 210 and
211 pertaining to current good manufacturing practice have been
approved under OMB control number 0910-0139.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at https://www.regulations.gov, https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, or https://www.fda.gov/regulatory-information/search-fda-guidance-documents.

    Dated: June 1, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-12099 Filed 6-6-23; 8:45 am]
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