[Federal Register: August 16, 2006 (Volume 71, Number 158)]
[Notices]
[Page 47195-47196]
[DOCID:fr16au06-64]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP06-414-001]

Northern Natural Gas Company; Notice of Compliance Filing

August 9, 2006.
    Take notice that on August 4, 2006, Northern Natural Gas Company
(Northern), tendered for filing as part of its FERC Gas Tariff, Fifth
Revised Volume No. 1, Substitute Tenth Revised Sheet No. 252, with an
effective date of August 1, 2006.
    Northern states that the filing is being made in compliance with
the Commission's July 31, 2006 order in this proceeding.
    Any person desiring to protest this filing must file in accordance
with Rule 211 of the Commission's Rules of Practice and Procedure (18
CFR 385.211). Protests to this filing 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. Such protests
must be filed in accordance with the provisions of Section 154.210 of
the Commission's regulations (18 CFR 154.210). Anyone filing a protest
must serve a copy of that document on all the parties to the
proceeding.
    The Commission encourages electronic submission of protests 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 to the Federal Energy Regulatory Commission, 888 First
Street, NE., Washington, DC 20426.
    This filing is accessible on-line 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. E6-13373 Filed 8-15-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 88, Number 151 (Tuesday, August 8, 2023)]
[Notices]
[Pages 53578-53579]
[FR Doc No: 2023-16942]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Docket No. FAA-2023-1532; Summary Notice No. 2023-30]

Petition for Exemption; Summary of Petition Received; The Boeing
Company

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of petition for exemption received.

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SUMMARY: This notice contains a summary of a petition seeking relief

from specified requirements of Federal Aviation Regulations. The
purpose of this notice is to improve the public's awareness of, and
participation in, the FAA's exemption process. Neither publication of
this notice nor the inclusion or omission of information in the summary
is intended to affect the legal status of the petition or its final
disposition.

DATES: Comments on this petition must identify the petition docket
number and must be received on or before August 28, 2023.

ADDRESSES: Send comments identified by docket number FAA-2023-1532
using any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov and follow the online instructions for sending your
comments electronically.
     Mail: Send comments to Docket Operations, M-30; U.S.
Department of Transportation (DOT), 1200 New Jersey Avenue SE, Room
W12-140, West Building Ground Floor, Washington, DC 20590-0001.
     Hand Delivery or Courier: Take comments to Docket
Operations in Room W12-140 of the West Building Ground Floor at 1200
New Jersey Avenue SE, Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
     Fax: Fax comments to Docket Operations at<PHONE_NUMBER>.
    Privacy: In accordance with 5 U.S.C. 553(c), DOT solicits comments
from the public to better inform its rulemaking process. DOT posts
these comments, without edit, including any personal information the
commenter provides, to http://www.regulations.gov, as described in the
system of records notice (DOT/ALL-14 FDMS), which can be reviewed at
http://www.dot.gov/privacy.
    Docket: Background documents or comments received may be read at
http://www.regulations.gov at any time. Follow the online instructions
for accessing the docket or go to the Docket Operations in Room W12-140
of the West Building Ground Floor at 1200 New Jersey Avenue SE,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Deana Stedman, AIR-646, Federal
Aviation Administration, phone<PHONE_NUMBER>, email
[email protected].
    This notice is published pursuant to 14 CFR 11.85.

    Issued in Los Angeles, California on August 3, 2023.
Thuan Nguyen,
Acting Manager, Technical Writing Section.

Petition for Exemption

    Docket No.: FAA-2023-1532.
    Petitioner: The Boeing Company.
    Section(s) of 14 CFR Affected: Sec. Sec.  25.1316(a) and
25.1317(a).
    Description of Relief Sought: The Boeing Company is petitioning for
a temporary exemption from the affected sections of 14 CFR until March
1, 2027 to allow it time to incorporate necessary design changes for
the Stall Management Yaw Damper on the Model 737-7 airplane.
[FR Doc. 2023-16942 Filed 8-7-23; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: March 13, 2009 (Volume 74, Number 48)]
[Notices]
[Page 10908-10909]
[DOCID:fr13mr09-48]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Notice of Filing

March 6, 2009.

BC Landfill Energy, LLC..................  ER09-503-000
AC Landfill Energy, LLC..................  ER09-504-000
WC Landfill Energy, LLC..................  ER09-505-000

    Take notice that, on March 5, 2009, BC Landfill Energy, LLC, AC
Landfill Energy, LLC, and WC Landfill Energy, LLC filed an amendment to
their January 7, 2009 applications for market-based rate authority in
the above-captioned dockets, pursuant to the Commissions' request. Such
filing serves to reset the filing dates in these proceedings.
    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, 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 on or before the comment date.
Anyone filing a motion to intervene or protest must serve a copy of
that document on the Applicant and all the parties in this proceeding.
    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 on-line 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>.

    Comment Date: 5 p.m. Eastern Time on March 16, 2009.

Kimberly D. Bose,
Secretary.
 [FR Doc. E9-5430 Filed 3-12-09; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 77 (Friday, April 23, 2021)]
[Proposed Rules]
[Pages 21673-21675]
[FR Doc No: 2021-08445]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2021-0211; Airspace Docket No. 21-ANM-7]
RIN 2120-AA66

Proposed Establishment of Class E airspace; Mountain Home, ID

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: This action proposes to establish Class E domestic en route
airspace extending upward from 1,200 feet above the surface at Mountain
Home, ID. This airspace would facilitate vectoring of Instrument Flight
Rules (IFR) aircraft and it would properly contain IFR aircraft
operating on direct routes under the control of Salt Lake City Air
Route Traffic Control Center (ARTCC). The FAA is proposing this

action to enhance the safety and management of IFR operations within
the National Airspace System (NAS).

DATES: Comments must be received on or before June 7, 2021.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, 1200 New Jersey Avenue SE, West
Building Ground Floor, Room W12-140, Washington, DC 20590; telephone:
1-800-647-5527, or<PHONE_NUMBER>. You must identify FAA Docket No.
FAA-2021-0211; Airspace Docket No. 21-ANM-7, at the beginning of your
comments. You may also submit comments through the internet at https://www.regulations.gov.
    FAA Order 7400.11E, Airspace Designations and Reporting Points, and
subsequent amendments can be viewed online at https://www.faa.gov/air_traffic/publications/. For further information, you can contact the
Airspace Policy Group, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783. The Order is also available for inspection at the National
Archives and Records Administration (NARA). For information on the
availability of FAA Order 7400.11E at NARA, email<EMAIL_ADDRESS>or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.

FOR FURTHER INFORMATION CONTACT: Matthew Van Der Wal, Federal Aviation
Administration, Western Service Center, Operations Support Group, 2200
S 216th Street, Des Moines, WA 98198; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority,
as it would establish Class E airspace at Mountain Home, ID, to support
IFR operations within the NAS.

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. Persons 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-2021-0211;
Airspace Docket No. 21-ANM-7''. 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 https://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's web page at https://www.faa.gov/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received, and any final disposition in person in the Dockets
Office (see the ADDRESSES section for the address and phone number)
between 9:00 a.m. and 5:00 p.m., Monday through Friday, except federal
holidays. An informal docket may also be examined during normal
business hours at the Northwest Mountain Regional Office of the Federal
Aviation Administration, Air Traffic Organization, Western Service
Center, Operations Support Group, 2200 S 216th Street, Des Moines, WA
98198.

Availability and Summary of Documents for Incorporation by Reference

    This document proposes to amend FAA Order 7400.11E, Airspace
Designations and Reporting Points, dated July 21, 2020, and effective
September 15, 2020. FAA Order 7400.11E is publicly available as listed
in the ADDRESSES section of this document. FAA Order 7400.11E lists
Class A, B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Proposal

    The FAA is proposing an amendment to 14 CFR part 71 by establishing
Class E en route domestic airspace extending upward from 1,200 feet
above the surface at Mountain Home, ID. This action would provide
controlled airspace to facilitate vectoring of IFR aircraft under the
control of Salt Lake City ARTCC. The airspace would also ensure proper
containment of IFR aircraft operating on direct routes where the
current en route structure is insufficient. This action would enhance
the safety and management of IFR operations within the NAS.
    Class E6 airspace designations are published in paragraph 6006 of
FAA Order 7400.11E, dated July 21, 2020, and effective September 15,
2020, which is incorporated by reference in 14 CFR 71.1. The Class E
airspace designations listed in this document will be published
subsequently in the Order.
    FAA Order 7400.11, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

Regulatory Notices and Analyses

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current, is
non-controversial, and unlikely to result in adverse or negative
comments. 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, would not have a
significant economic impact on a substantial number of small entities
under the criteria of the Regulatory Flexibility Act.

Environmental Review

    This proposal will be subject to an environmental analysis in
accordance with FAA Order 1050.1F,

``Environmental Impacts: Policies and Procedures'' prior to any FAA
final regulatory action.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    Accordingly, pursuant to the authority delegated to me, 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

0
1. The authority citation for 14 CFR part 71 continues to read as
follows:

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

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.11E,
Airspace Designations and Reporting Points, dated July 21, 2020, and
effective September 15, 2020, is amended as follows:

Paragraph 6006 En Route Domestic Airspace Areas.

* * * * *

ANM ID E6 Mountain Home, ID

    That airspace extending upward from 1,200 feet above the surface
within an area beginning at Lat. 43[deg]05'36'' N, long.
114[deg]51'26'' W; to Lat. 42[deg]26'27'' N, long. 114[deg]57'44''
W; to Lat. 42[deg]25'53'' N, long. 116[deg]03'43'' W; to Lat.
43[deg]07'42'' N, long. 116[deg]44'08'' W; to Lat. 44[deg]03'18'' N,
long. 117[deg]05'05'' W; to Lat. 44[deg]15'42'' N, long.
116[deg]19'34'' W; to Lat. 44[deg]03'41'' N, long. 116[deg]12'15''
W; to Lat. 43[deg]58'04'' N, long. 115[deg]51'09'' W; to Lat.
43[deg]47'52'' N, long. 115[deg]41'21'' W; to Lat. 43[deg]30'14'' N,
long. 115[deg]36'38'' W; to Lat. 43[deg]17'24'' N, long.
115[deg]41'05'' W; to Lat. 43[deg]03'38'' N, long. 115[deg]19'32''
W; then to the point of beginning.

    Issued in Des Moines, Washington, on April 19, 2021.
B.G. Chew,
Acting Group Manager, Operations Support Group, Western Service Center.
[FR Doc. 2021-08445 Filed 4-22-21; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 78, Number 55 (Thursday, March 21, 2013)]
[Notices]
[Pages 17422-17423]
[FR Doc No: 2013-06485]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4104-DR; Docket ID FEMA-2013-0001]

Navajo Nation; Major Disaster and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This is a notice of the Presidential declaration of a major
disaster for the Navajo Nation (FEMA-4104-DR), dated March 5, 2013, and
related determinations.

DATES: Effective Date: March 5, 2013.

FOR FURTHER INFORMATION CONTACT: Dean Webster, 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, in a letter
dated March 5, 2013, the President issued a major disaster declaration
under the authority of the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the ``Stafford
Act''), as follows:

    I have determined that the damage to the lands associated with
the Navajo Nation resulting from a severe freeze during the period
of December 15, 2012 to January 21, 2013, is of sufficient severity
and magnitude to warrant a major disaster declaration under the
Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42
U.S.C. 5121 et seq. (the ``Stafford Act''). Therefore, I declare
that such a major disaster exists for the Navajo Nation and
associated lands.
    In order to provide Federal assistance, you are hereby
authorized to allocate from funds available for these purposes such
amounts as you find necessary for Federal disaster assistance and
administrative expenses.
    You are authorized to provide assistance for emergency
protective measures and utilities (Categories B and F) under the
Public Assistance program and Hazard Mitigation for the Navajo
Nation and associated lands. Consistent with the requirement that
Federal assistance is supplemental, any Federal

funds provided under the Stafford Act for Public Assistance and
Hazard Mitigation will be limited to 75 percent of the total
eligible costs.
    Further, you are authorized to make changes to this declaration
for the approved assistance to the extent allowable under the
Stafford Act.

    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Administrator, under
Executive Order 12148, as amended, Mark A. Neveau, of FEMA is appointed
to act as the Federal Coordinating Officer for this major disaster.
    The following areas have been designated as adversely affected by
this major disaster:

    The Navajo Nation and associated lands for emergency protective
measures and utilities (Categories B and F) under the Public
Assistance program.
    The Navajo Nation is eligible to apply for assistance under the
Hazard Mitigation Grant Program.
    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. 2013-06485 Filed 3-20-13; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register: May 4, 2010 (Volume 75, Number 85)]
[Rules and Regulations]
[Page 23592-23593]
[DOCID:fr04my10-18]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2010-0256]
RIN 1625-AA00

Safety Zone; Neuse River, New Bern, NC; Correction

ACTION: Temporary final rule; correction.

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SUMMARY: In the Federal Register published on April 23, 2010, the Coast
Guard established a temporary safety zone on the waters of the Neuse
River in support of the New Bern, North Carolina Tercentennial
Celebration. The City of New Bern, North Carolina is sponsoring a civil
war naval bombardment reenactment on the waters of the Neuse River, New
Bern, North Carolina on May 8, 2010. The safety zone published with an
error in the temporary safety zone coordinates. The safety zone
coordinates should have read ``35[deg]06'12'' N; 077[deg]02'12'' W
thence to 35[deg]05'52'' N; 077[deg]02'15'' W thence to 35[deg]05'49''
N; 077[deg]01'49'' W thence to 35[deg]06'17'' N; 077[deg]01'48'' W
thence to 35[deg]06'21'' N; 077[deg]02'06'' W''.

DATES: This correction is effective May 4, 2010.

FOR FURTHER INFORMATION CONTACT: For information about this correction,
contact Jennifer Mehaffey, Office of Regulations and Administrative
Law,

(202) 372-3859<EMAIL_ADDRESS>For information about the
original regulation, contact CWO4 Stephen Lyons, Waterways Management
Division Chief, Coast Guard Sector North Carolina; telephone (252) 247-
4525, e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In FR doc 2010-9497 appearing on page 21164
in the issue of Friday, April 23, 2010, the following corrections are
made:
    1. In the Discussion of the Rule section on page 21165, in the
second column, revise the temporary safety zone coordinates to read
``35[deg]06'12'' N; 077[deg]02'12'' W thence to 35[deg]05'52'' N;
077[deg]02'15'' W thence to 35[deg]05'49'' N; 077[deg]01'49'' W thence
to 35[deg]06'17'' N; 077[deg]01'48'' W thence to 35[deg]06'21'' N;
077[deg]02'06'' W''.

Sec.  165.T05-0256  [Corrected]

0
2. In the regulatory text on page 21166, third column, revise paragraph
(b) safety zone coordinates to read ``35[deg]06'12'' N; 077[deg]02'12''
W thence to 35[deg]05'52'' N; 077[deg]02'15'' W thence to
35[deg]05'49'' N; 077[deg]01'49'' W thence to 35[deg]06'17'' N;
077[deg]01'48'' W thence to 35[deg]06'21'' N; 077[deg]02'06'' W''.

    Dated: April 29, 2010.
S. Venckus,
Office of Regulations and Administrative Law (CG-0943), U.S. Coast
Guard.
[FR Doc. 2010-10496 Filed 4-30-10; 11:15 am]
BILLING CODE 9110-04-P


[Federal Register Volume 82, Number 89 (Wednesday, May 10, 2017)]
[Notices]
[Pages 21818-21819]
[FR Doc No: 2017-09442]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-2497]

Draft Revisions to the Food and Drug Administration Blueprint for
Prescriber Education for Extended-Release and Long-Acting Opioids;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of draft revisions to the ``FDA Blueprint for
Prescriber Education for Extended-Release and Long-Acting Opioid
Analgesics'' (Blueprint). The Blueprint is part of the FDA-approved
risk evaluation and mitigation strategy (REMS) for extended release
(ER) and long-acting (LA) opioid analgesic medications (ER/LA Opioid
Analgesics REMS).
    FDA is seeking comment on the draft revisions to the Blueprint and
has added sections of draft revised Blueprint to the background
materials for the public workshop scheduled for May 9-10, 2017.
Although the draft revisions to the Blueprint will not be a discussion
topic at the workshop, FDA expects the draft revisions to provide
important context for discussions during the workshop.

DATES: To ensure that FDA considers your comments on the draft
revisions to the Blueprint, submit either electronic or written
comments by July 10, 2017.

ADDRESSES: You may submit comments 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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, 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-2017-D-2497 for ``Draft Revisions to FDA Blueprint for Prescriber
Education for Extended-Release and Long-Acting Opioids; Request for
Comments.'' 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 Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.
     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 Division of Dockets Management. 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.gpo.gov/fdsys/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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the draft revised
Blueprint 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. Send one self-addressed adhesive label to assist that
office in processing your requests. See the SUPPLEMENTARY INFORMATION
section for electronic access to the draft revised Blueprint.

FOR FURTHER INFORMATION CONTACT: Janelle Derbis, Center for Drug
Evaluation and Research (HFD-1), Food and Drug Administration 20 North
Michigan Ave., Suite 510, Chicago, IL 60602,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: FDA is announcing the availability of draft
revisions to the ``FDA Blueprint for Prescriber Education for Extended-
Release and Long-Acting Opioid Analgesics'' (draft revisions to the
Blueprint). In addition to seeking comment on the draft revisions to
the Blueprint, FDA expects the draft revisions to create important
context for discussions at a public workshop on issues and challenges
associated with Federal efforts to support training on pain management
and the safe prescribing, dispensing, and patient use of opioids (safe
use of opioids) for health care providers. That workshop, which is
scheduled for May 9-10, 2017, was previously announced in the Federal
Register on April 18, 2017 (82 FR 18300).

I. Background

    On July 12, 2012, FDA approved an ER/LA Opioid Analgesics REMS,
including an FDA-created ``Blueprint for Prescriber Education for
Extended-Release and Long-Acting (ER/LA) Opioid Analgesics.'' The goal
of the REMS is to reduce serious adverse outcomes resulting from
inappropriate prescribing, misuse, and abuse of ER/LA opioid analgesics
while maintaining patient access to pain medications.
    The ER/LA Opioid Analgesics REMS requires that training in the form
of accredited continuing education be made available to health care
providers who prescribe ER/LA opioid analgesics. The accredited
continuing education must include all elements of the FDA Blueprint,
which includes a basic outline and the core messages related to ER/LA
opioid analgesics. FDA developed the Blueprint following extensive
input from stakeholders and sought input on a draft version on November
7, 2011 (76 FR 68766), before approving it in 2012 as part of the ER/LA
Opioid Analgesics REMS.
    On May 3-4, 2016, FDA convened a joint meeting of the Drug Safety
and Risk Management Advisory Committee and the Anesthetic and Analgesic
Drug Products Advisory Committee to discuss whether this REMS assures
safe use of these products; whether or not it is unduly burdensome to
patient access to the drugs; and whether it (to the extent practicable)
minimizes the burden to the health care delivery system (March 14,
2016, 81 FR 13372). FDA also sought input on possible modifications to
the ER/LA Opioid Analgesic REMS, including expansion of the scope and
content of prescriber training and expansion of the REMS program to
include immediate release (IR) opioid analgesics. Advisory Committee
members were in favor of modifying the REMS program to include the IR
opioid analgesics as well as broadening the training program to include
pain management. The majority of the members were in favor of a
requirement for all prescribers to complete training. Many of the
members recommended that the required training program be implemented
through mechanisms outside the FDA REMS authority. The majority of
members also stated that other health care providers involved in the
management of pain should be included as a target audience for
education, though they did not specify that the training should be
mandatory for non-prescribing health care providers.

II. Potential Modifications to the FDA Blueprint

    FDA is considering modifications to the existing Blueprint in light
of recommendations from the May 2016 Advisory Committee meeting. The
draft revisions to the Blueprint being made available pursuant to this
notice would broaden the Blueprint to include information on pain
management, including the principles of acute and chronic pain
management; non-pharmacologic treatments for pain; and pharmacologic
treatments for pain (both non-opioid analgesic and opioid analgesic).
FDA intends to consider public input as it considers modifications to
the ER/LA Opioid Analgesics REMS.

III. May 2017 Public Workshop

    On April 18, 2017, FDA published a notice announcing a public
workshop scheduled for May 9-10, 2017, to seek input on issues and
challenges associated with Federal efforts to support training on pain
management and the safe prescribing, dispensing, and patient use of
opioids (safe use of opioids) for health care providers. Through the
public workshop, FDA hopes to obtain additional insight from a variety
of stakeholders on how best to ensure that health care providers
receive training in pain management and the safe use of opioids. The
draft revisions to the Blueprint being made available at https://www.fda.gov/Drugs/NewsEvents/ucm553931.htm are intended to provide
important context for the public workshop's discussion. However, the
Blueprint itself will not be a discussion topic at the workshop. FDA
intends to consider any comments submitted to this docket as it
considers possible modifications to the ER/LA Opioid Analgesics REMS.

    Dated: May 4, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-09442 Filed 5-9-17; 8:45 am]
 BILLING CODE 4164-01-P