[Federal Register Volume 86, Number 46 (Thursday, March 11, 2021)]
[Rules and Regulations]
[Pages 13807-13809]
[FR Doc No: 2021-05046]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2020-1118; Project Identifier MCAI-2020-00516-E;
Amendment 39-21451; AD 2021-05-08]
RIN 2120-AA64

Airworthiness Directives; Safran Helicopter Engines, S.A. (Type
Certificate Previously Held by Turbomeca, S.A.) Turboshaft Engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: The FAA is adopting a new airworthiness directive (AD) for all
Safran Helicopter Engines, S.A. Arriel 2C, 2C1, 2S1, and 2S2 model
turboshaft engines. This AD was prompted by investigations by the
manufacturer following level 1 failures in flight (minor anomalies) and
level 2 failures on the ground (minor failures), where cracks were
found on the soldered joints of torque conformation boxes. This AD
requires performing initial and repetitive inspections of the
resistance values of the torque conformation box and, depending on the
results of the inspections, replacement of the torque conformation box.
The FAA is issuing this AD to address the unsafe condition on these
products.

DATES: This AD is effective April 15, 2021.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of April 15,
2021.

ADDRESSES: For service information identified in this final rule,
contact Safran Helicopter Engines, S.A., Avenue du 1er Mai, Tarnos,
France; phone: +33 (0) 5 59 74 45 11. You may view this service
information at the FAA, Airworthiness Products Section, Operational
Safety Branch, 1200 District Avenue, Burlington, MA 01803. For
information on the availability of this material at the FAA, call (781)
238-7759. It is also available at https://www.regulations.gov by
searching for and locating Docket No. FAA-2020-1118.

Examining the AD Docket

    You may examine the AD docket at https://www.regulations.gov by
searching for and locating Docket No. FAA-2020-1118; or in person at
Docket Operations between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The AD docket contains this final rule, the
mandatory continuing airworthiness information (MCAI), any comments
received, and other information. The address for Docket Operations is
U.S. Department of Transportation, Docket Operations, M-30, West
Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE,
Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Wego Wang, Aviation Safety Engineer,
ECO Branch, FAA, 1200 District Avenue, Burlington, MA 01803; phone:
(781) 238-7134; fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Background

    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 by adding an AD that would apply to all Safran Helicopter
Engines, S.A. Arriel 2C, 2C1, 2S1, and 2S2 model turboshaft engines.
The NPRM published in the Federal Register on

December 10, 2020 (85 FR 79438). The NPRM was prompted by
investigations by the manufacturer following level 1 failures in flight
(minor anomalies) and level 2 failures on the ground (minor failures),
where cracks were found on the soldered joints of torque conformation
boxes. In the NPRM, the FAA proposed to require performing initial and
repetitive inspections of the resistance values of the torque
conformation box and, depending on the results of the inspections,
replacement of the torque conformation box. The FAA is issuing this AD
to address the unsafe condition on these products.
    The European Union Aviation Safety Agency (EASA), which is the
Technical Agent for the Member States of the European Community, has
issued EASA AD 2019-0110, dated May 21, 2019 (referred to after this as
``the MCAI''), to address the unsafe condition on these products. The
MCAI states:

    It was reported that, during investigations following level 1
failures in flight (minor anomalies) and level 2 failures on the
ground (minor failures), cracks were found on the soldered joints of
certain torque conformation boxes. Although no events in operation
were reported of One Engine Inoperative (OEI) ratings maximum power
unavailability, the failure mode analysis for these boxes
demonstrated that such event could not be excluded. This condition,
if not detected and corrected, could lead to engine in-flight shut-
down, possibly resulting in reduced control of the helicopter.
    To address this potential unsafe condition, SAFRAN Helicopter
Engines issued the SB [Service Bulletin], to provide instructions
for repetitive checks of the box resistance values. For the reasons
described above, this [EASA] AD requires repetitive checks of the
affected part and, depending on findings, replacement of the
affected part with a serviceable part.

    You may obtain further information by examining the MCAI in the AD
docket at https://www.regulations.gov by searching for and locating
Docket No. FAA-2020-1118.

Discussion of Final Airworthiness Directive Comments

    The FAA received no comments on the NPRM or on the determination of
the costs.

Conclusion

    The FAA reviewed the relevant data and determined that air safety
requires adopting this AD as proposed. Accordingly, the FAA is issuing
this AD to address the unsafe condition on these products. This AD is
adopted as proposed in the NPRM.

Related Service Information Under 1 CFR Part 51

    The FAA reviewed Safran Helicopter Engines Mandatory Service
Bulletin (MSB) No. 292 72 2868, Version A, dated December 2018. This
service information specifies procedures for performing an inspection
of the resistance values of the torque conformation box. This service
information is reasonably available because the interested parties have
access to it through their normal course of business or by the means
identified in ADDRESSES.

Costs of Compliance

    The FAA estimates that this AD affects 257 engines installed on
helicopters of U.S. registry.
    The FAA estimates the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
                Action                         Labor cost           Parts cost        product        operators
----------------------------------------------------------------------------------------------------------------
Inspect resistance values of the        1 work-hour x $85 per                 $0             $85         $21,845
 torque conformation box.                hour = $85.
----------------------------------------------------------------------------------------------------------------

    The FAA estimates the following costs to do any necessary
replacement that would be required based on the results of the
inspections. The agency has no way of determining the number of
aircraft that might need this replacement:

                                               On-Condition Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per
                    Action                                 Labor cost               Parts cost        product
----------------------------------------------------------------------------------------------------------------
Replace the torque conformation box...........  1 work-hour x $85 per hour = $85          $1,841          $1,926
----------------------------------------------------------------------------------------------------------------

    The FAA has included all known costs in its cost estimate.
According to the manufacturer, however, some of the costs of this AD
may be covered under warranty, thereby reducing the cost impact on
affected individuals.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. 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.
    The FAA is issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: General requirements.
Under that section, Congress charges the FAA with promoting safe flight
of civil aircraft in air commerce by prescribing regulations for
practices, methods, and procedures the Administrator finds necessary
for safety in air commerce. This regulation is within the scope of that
authority because it addresses an unsafe condition that is likely to
exist or develop on products identified in this rulemaking action.

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government.
    For the reasons discussed above, I certify this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Will not affect intrastate aviation in Alaska, and

    (3) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive:

2021-05-08 Safran Helicopter Engines, S.A. (Type Certificate
previously held by Turbomeca, S.A.): Amendment 39-21451; Docket No.
FAA-2020-1118; Project Identifier MCAI-2020-00516-E.

(a) Effective Date

    This airworthiness directive (AD) is effective April 15, 2021.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to all Safran Helicopter Engines, S.A. (Type
Certificate previously held by Turbomeca, S.A.) Arriel 2C, 2C1, 2S1,
and 2S2 model turboshaft engines.

(d) Subject

    Joint Aircraft System Component (JASC) Code 7712, Engine BMEP/
Torque Indicating.

(e) Unsafe Condition

    This AD was prompted by investigations by the manufacturer
following level 1 failures in flight (minor anomalies) and level 2
failures on the ground (minor failures), where cracks were found on
the soldered joints of torque conformation boxes. The FAA is issuing
this AD to prevent failure of the torque conformation box. The
unsafe condition, if not addressed, could result in failure of the
engine, in-flight shutdown, and loss of the helicopter.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Required Actions

    (1) For engines with the torque conformation box in pre-
modification TU 34 configuration, installed on Arriel 2C and 2C1
model turboshaft engines; pre-modification TU 34 or post-
modification TU 188 configuration, installed on Arriel 2S1 model
turboshaft engines; or post-modification TU 188 configuration,
installed on Arriel 2S2 model turboshaft engines:
    (i) Within 600 engine hours (EHs) or 180 days after the
effective date of this AD, whichever occurs first, perform an
initial inspection of the resistance values of the torque
conformation box.

    Note 1 to paragraph (g)(1)(i):  You may delay the initial
inspection by up to 60 EHs to align with other scheduled maintenance
tasks.

    (ii) Thereafter, perform repetitive inspections of the
resistance values of the torque conformation box before exceeding
600 EHs since the last inspection of the resistance values of the
torque conformation box.
    (2) Use the Accomplishment Instructions, paragraph 2.3.2 or
4.3.2, of Safran Helicopter Engines Mandatory Service Bulletin No.
292 72 2868, Version A, dated December 2018, to perform the
inspections of the resistance values of the torque conformation box
required by paragraph (g)(1) of this AD.
    (3) If, during any inspection required by paragraph (g)(1) of
this AD, a non-conforming resistance value is found, before further
flight, remove the torque conformation box from service and replace
it with a part eligible for installation.

(h) Definition

    For the purpose of this AD, a ``part eligible for installation''
is a zero hour torque conformation box or a torque conformation box
that has been inspected as required by paragraph (g)(1) of this AD.

(i) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, ECO Branch, FAA, has the authority to approve
AMOCs for this AD, if requested using the procedures found in 14 CFR
39.19. In accordance with 14 CFR 39.19, send your request to your
principal inspector or local Flight Standards District Office, as
appropriate. If sending information directly to the manager of the
certification office, send it to the attention of the person
identified in Related Information. You may email your request to:
<EMAIL_ADDRESS>    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.

(j) Related Information

    (1) For more information about this AD, contact Wego Wang,
Aviation Safety Engineer, ECO Branch, FAA, 1200 District Avenue,
Burlington, MA 01803; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>;
email<EMAIL_ADDRESS>    (2) Refer to European Union Aviation Safety Agency (EASA) AD
2019-0110, dated May 21, 2019, for more information. You may examine
the EASA AD in the AD docket at https://www.regulations.gov by
searching for and locating Docket No. FAA-2020-1118.

(k) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Safran Helicopter Engines Mandatory Service Bulletin No. 292
72 2868, Version A, dated December 2018.
    (ii) [Reserved]
    (3) For Safran Helicopter Engines service information identified
in this AD, contact Safran Helicopter Engines, S.A., Avenue du 1er
Mai, Tarnos, France; phone: +33 (0) 5 59 74 45 11.
    (4) You may view this service information at FAA, Airworthiness
Products Section, Operational Safety Branch, 1200 District Avenue,
Burlington, MA 01803. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, email<EMAIL_ADDRESS>or go to: https://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on February 19, 2021.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2021-05046 Filed 3-10-21; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 83, Number 169 (Thursday, August 30, 2018)]
[Proposed Rules]
[Pages 44249-44250]
[FR Doc No: 2018-18768]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2018-0683; Airspace Docket No. 18-AGL-17]
RIN 2120-AA66

Proposed Amendment of Class E Airspace; Lapeer, MI

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: This action proposes to amend Class E airspace extending
upward from 700 feet above the surface at Dupont-Lapeer Airport,
Lapeer, MI. The FAA is proposing this action as the result of an
airspace review caused by the decommissioning of the Pontiac VHF
omnidirectional range (VOR) navigation aid, which provided navigation
information for the instrument procedures at this airport, as part of
the VOR Minimum Operational Network (MON) Program. Airspace redesign
would enhance the safety and management of instrument flight rules
(IFR) operations at this airport.

DATES: Comments must be received on or before October 15, 2018.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590; telephone
(202) 366-9826, or<PHONE_NUMBER>. You must identify FAA Docket No.
FAA-2018-0683; Airspace Docket No. 18-AGL-17, at the beginning of your
comments. You may also submit comments through the internet at http://www.regulations.gov. You may review the public docket containing the
proposal, any comments received, and any final disposition in person in
the Dockets Office between 9:00 a.m. and 5:00 p.m., Monday through
Friday, except Federal holidays.
    FAA Order 7400.11B, Airspace Designations and Reporting Points, and
subsequent amendments can be viewed online at http://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 7400.11B at NARA, call<PHONE_NUMBER>, or go
to http://www.archives.gov/federal-register/cfr/ibr-locations.html.
    FAA Order 7400.11, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

FOR FURTHER INFORMATION CONTACT: Jeffrey Claypool, Federal Aviation
Administration, Operations Support Group, Central Service Center, 10101
Hillwood Parkway, Fort Worth, TX 76177; 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 amend Class E airspace extending upward from 700 feet above
the surface at Dupont-Lapeer Airport, Lapeer, MI, to

support instrument flight rules operations at this airport.

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-2018-0683;
Airspace Docket No. 18-AGL-17.'' 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://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's web page at http://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 Federal Aviation Administration, Air Traffic
Organization, Central Service Center, Operations Support Group, 10101
Hillwood Parkway, Fort Worth, TX 76177.

Availability and Summary of Documents for Incorporation by Reference

    This document proposes to amend FAA Order 7400.11B, Airspace
Designations and Reporting Points, dated August 3, 2017, and effective
September 15, 2017. FAA Order 7400.11B is publicly available as listed
in the ADDRESSES section of this document. FAA Order 7400.11B 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 Title 14 Code of Federal
Regulations (14 CFR) part 71 by amending the Class E airspace extending
upward from 700 feet above the surface to within a 6.4-mile radius
(decreased from a 6.5-mile radius) at Dupont-Lapeer Airport, Lapeer,
MI; and amending the extension to the north to extend from the 6.4-mile
radius (decreased from the 6.5-mile radius) to 11.0 miles (increased
from 10.9 miles) north of the airport.
    This action is necessary due to an airspace review caused by the
decommissioning of the Pontiac VOR, which provided navigation
information to the instrument procedures at this airport, as part of
the VOR MON Program.
    Class E airspace designations are published in paragraph 6005 of
FAA Order 7400.11B, dated August 3, 2017, and effective September 15,
2017, which is incorporated by reference in 14 CFR 71.1. The Class E
airspace designation listed in this document will be published
subsequently in the Order.

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 7400.11B,
Airspace Designations and Reporting Points, dated August 3, 2017, and
effective September 15, 2017, is amended as follows:

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

* * * * *

AGL MI E5 Lapeer, MI [Amended]

Dupont-Lapeer Airport, MI
    (Lat. 43[deg]03'59'' N, long. 83[deg]16'18'' W)

    That airspace extending upward from 700 feet above the surface
within a 6.4-mile radius of Dupont-Lapeer Airport, and within 2.0
miles each side of the 357[deg] bearing from the airport extending
from the 6.4-mile radius to 11.0 miles north of the airport.

    Issued in Fort Worth, Texas, on August 23, 2018.
Walter Tweedy,
Acting Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2018-18768 Filed 8-29-18; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 78, Number 218 (Tuesday, November 12, 2013)]
[Notices]
[Page 67381]
[FR Doc No: 2013-26986]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4152-DR; Docket ID FEMA-2013-0001]

New Mexico; 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 State of New Mexico (FEMA-4152-DR), dated October 29,
2013, and related determinations.

DATES: Effective Date: October 29, 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 October 29, 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 in certain areas of the State
of New Mexico resulting from severe storms, flooding, and mudslides
during the period of September 9-22, 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 in the State of New Mexico.
    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 Public Assistance in the
designated areas and Hazard Mitigation throughout the State.
Consistent with the requirement that Federal assistance be
supplemental, any Federal funds provided under the Stafford Act for
Hazard Mitigation will be limited to 75 percent of the total
eligible costs. Federal funds provided under the Stafford Act for
Public Assistance also will be limited to 75 percent of the total
eligible costs, with the exception of projects that meet the
eligibility criteria for a higher Federal cost-sharing percentage
under the Public Assistance Alternative Procedures Pilot Program for
Debris Removal implemented pursuant to section 428 of the Stafford
Act.
    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, Nancy M. Casper, of FEMA is
appointed to act as the Federal Coordinating Officer for this major
disaster.
    The following areas of the State of New Mexico have been designated
as adversely affected by this major disaster:

    Catron, Chaves, Cibola, Colfax, Eddy, Guadalupe, Los Alamos,
McKinley, Mora, Sandoval, San Miguel, Santa Fe, Sierra, Socorro, and
Torrance Counties for Public Assistance.
    All counties within the State of New Mexico are 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. 2013-26986 Filed 11-8-13; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 81, Number 237 (Friday, December 9, 2016)]
[Notices]
[Pages 89183-89184]
[FR Doc No: 2016-29500]

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DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

[Docket No. PHMSA-2016-0137)

Pipeline Safety: Safeguarding and Securing Pipelines From
Unauthorized Access

AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA);
DOT.

ACTION: Notice; issuance of Advisory Bulletin.

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SUMMARY: PHMSA is issuing this Advisory Bulletin in coordination with
the Department of Homeland Security's (DHS), Transportation Security
Administration (TSA), to remind all pipeline owners and operators of
the importance of safeguarding and securing their pipeline facilities
and monitoring their Supervisory Control and Data Acquisition (SCADA)
systems for abnormal operations and/or indications of unauthorized
access or interference with safe pipeline operations. Additionally,
this Advisory Bulletin is to remind the public of the dangers
associated with tampering with pipeline system facilities.
    This Advisory Bulletin follows recent incidents in the United
States that highlight threats to oil and gas infrastructure. On October
11, 2016, several unauthorized persons accessed and interfered with
pipeline operations in four states, creating the potential for serious
infrastructure damage and significant economic and environmental harm,
as well as endangering public safety. While the incidents did not
result in any damage or injuries, the potential impacts emphasize the
need for increased awareness and vigilance.

FOR FURTHER INFORMATION CONTACT: Operators of pipelines subject to
regulation by DOT, PHMSA, should contact Nathan A. Schoenkin by phone
at<PHONE_NUMBER> or by email at<EMAIL_ADDRESS>Information
about PHMSA may be found at http://phmsa.dot.gov. Pipeline operators
with questions on TSA's Pipeline Security Guidelines should contact
Steven Froehlich by phone at<PHONE_NUMBER> or by email at
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

Incident Details

    On Tuesday October 11, 2016, individuals contacted four pipeline
operators informing them they would shut down the pipelines used to
transport crude oil from Canada to the United States. The operators
(Enbridge, Kinder Morgan, Spectra Energy, and TransCanada) took steps
to prevent damage to the pipelines and contacted local and federal law
enforcement. The individuals cut the chains and padlocks at valve sites
near Leonard, Minnesota; Burlington, Washington; Eagle Butte, Montana;
and Wahalla, North Dakota. The individuals then closed valves on
Enbridge's Lines 4 and 67, Spectra Energy's Express Pipeline, and
TransCanada's Keystone Pipeline. The Kinder Morgan Trans Mountain's
Puget Sound Pipeline was not operating at the time. Several individuals
were arrested by local law enforcement.
    Had the pipeline operators not shut down their lines in response to
the threats, a pipeline rupture could have occurred. A pipeline rupture
due to tampering with valves can have significant consequences such as
death, injury, and economic and environmental harm.

Pipeline Safety and Security

    PHMSA and TSA have a mutual interest in ensuring coordinated,
consistent, and effective activities that improve interagency
cooperation on transportation security and safety matters. PHMSA
focuses on the safety of the Nation's pipelines and administers the
pipeline safety regulatory program (49 CFR part 190-199). TSA focuses
on the security of the Nation's pipelines and has authored Pipeline
Security Guidelines for operators available online at https://www.tsa.gov/sites/default/files/tsapipelinesecurityguidelines-2011.pdf.

II. Advisory Bulletin (ADB-2016-06)

    To: Owners and Operators of Hazardous Liquid, Carbon Dioxide and
Gas Pipelines
    Subject: Safeguarding and Securing Pipelines from Unauthorized
Access
    Advisory: PHMSA is issuing this Advisory Bulletin in coordination
with TSA to remind all pipeline owners and operators of the importance
of safeguarding and securing their pipeline facilities and monitoring
their SCADA systems for abnormal operations and/or indications of
unauthorized access or interference with safe pipeline operations.
Additionally, this Advisory Bulletin is to remind the public of the
dangers associated with tampering with pipeline system facilities.

If You See Something, Say SomethingTM

    Tampering with pipeline facilities can have deleterious effects on
the safety of the Nation's pipeline system. Tampering or acts of
sabotage can also lead to the loss of life, injury, and significant
harm to the economy and environment. At 49 CFR 190.291, any person that
willingly and knowingly injures or destroys, or attempts to injure or
destroy a pipeline facility is subject to a fine in Title 18 of the
United States Code and imprisonment for a term not to exceed 20 years
for each offense. Individuals are reminded that ``If you See Something,
Say Something''TM applies to the safety and security of our
national pipeline infrastructure. Individuals that see something
suspicious should reach out to their local law enforcement. Informed,
alert communities play a vital role in keeping our Nation's energy
infrastructure safe. Emphasizing that ``Homeland Security Starts with
Hometown Security,'' DHS encourages businesses to ``Connect, Plan for,
Train, and Report''. Tools and resources to help businesses plan,
prepare, and protect themselves from suspicious activities or attacks
are located online at https://www.dhs.gov/hometown-security.

Relationships With Local Law Enforcement

    PHMSA reminds pipeline operators that a strong relationship with
local law enforcement is extremely beneficial for safe pipeline
operations. Two-way communications between operators and law
enforcement can help to stop threats before they occur. Relationships
should be cultivated well in advance of an incident to facilitate
mutually dependable communication during an incident.

Increased Security Patrols

    Pipeline operators should consider increasing the frequency of
security patrols along their right of ways. Operators may want to
consider the use of new technologies to aid in pipeline security
patrols, such as unmanned aerial systems if authorized in the areas of
operation. Frequent patrols may help inform pipeline companies of
individuals who regularly congregate near a pipeline, or of potentially
unsafe conditions at a valve or pump station. Information regarding
suspicious individuals should be promptly forwarded to federal, state,
and local law enforcement.

Protection of Facilities

    PHMSA's Office of Pipeline Safety requires pipeline operators to
provide protection for valves on hazardous liquid pipelines at 49 CFR
195.420(c). Additionally, at 49 CFR 195.436, hazardous liquid pipeline
operators are required to provide protection for each pumping station,
breakout tank area, and other exposed facility from vandalism and
unauthorized entry. Furthermore, at 49 CFR 192.179(b)(1), natural and
other gas pipeline operators must ensure that the valve and operating
device to open or close the valve must be protected from tampering and
damage. PHMSA recommends that pipeline operators review their valve and
facility protection measures and consider taking additional steps to
secure them.
    Operators should evaluate what type of locks and security fences
are being used at valve stations and if they are capable of preventing
unauthorized personnel from gaining access to pipeline valve
facilities. Pipeline operators may choose to make mechanical operation
of valves more difficult without proper equipment.
    The use of deterrent text and signage at pipeline facilities may be
beneficial to decrease acts of sabotage against a pipeline facility.
The text should include the potential consequences if a valve is closed
improperly and a rupture was to occur. Additionally the deterrent text
should include reference to the PHMSA regulation found at 49 CFR
190.291 discussing the criminal penalties for tampering with pipeline
facilities. Remote facilities should consider equipping the facilities
with motion sensing cameras and/or motion detectors to alert control
centers of tampering.

SCADA System Monitoring

    Due to the criticality of SCADA systems in the safe operations of a
pipeline, operators should have strong protocols in place to ensure the
systems will not be tampered with. SCADA systems can be tampered with
or disabled by a physical or cyber vector. PHMSA is aware of prior
intrusion attempts on pipeline infrastructure. An operator should
harden physical and software borders around SCADA systems to limit the
risk to the safe operation of pipelines. The following methods can be
used to harden the software and physical borders around the SCADA
system: (1) Segregating the control system network from the corporate
network; (2) Limiting remote connection ports to the control system,
and if necessary requiring token-based authentication to gain access;
(3) Adding physical protection around remote sites with SCADA network
access; (4) Enhancing user access control on SCADA system networks and
devices and limiting access to critical system to individuals with a
safety/business need; and [5] Employing application whitelisting and
strict policies on peripheral devices (to include removable media,
printers, scanners, etc.) connected to the SCADA network.
    Furthermore, DHS's Industrial Control System Cyber Emergency
Response Team (ICS-CERT) developed a guidance document titled:
``Recommended Practice: Improving Industrial Control System
Cybersecurity with Defense-in-Depth Strategies.'' The document provides
guidance for developing mitigation strategies for specific cyber
threats and direction on how to create a Defense-in-Depth security
program for control system environments, and is available online at
https://ics-cert.us-cert.gov/sites/default/files/recommended_practices/NCCIC_ICS-CERT_Defense_in_Depth_2016_S508C.pdf.

Incident and Accident Reporting

    Operators are reminded that incidents and accidents must be
promptly reported to the appropriate federal, state, and local agency.
Requirements for immediate notification of certain incident and
accident reporting requirements are found at 49 CFR 191.5 and 195.52.
Furthermore, since tampering with a pipeline can lead to a release,
PHMSA recommends that operators should contact the National Response
Center by telephone to<PHONE_NUMBER> (in Washington, DC,<PHONE_NUMBER>)
following any physical security event that may interfere with the safe
operation of a pipeline. Please note only ``unclassified'' incident
details should be reported by phone to the National Response Center.
    TSA recommends in its Pipeline Security Guidelines that pipeline
operators notify the Transportation Security Operations Center via
phone at<PHONE_NUMBER> or email at<EMAIL_ADDRESS>as soon as possible
to report security concerns or suspicious activity. Furthermore it is
recommended that pipeline operators notify DHS's ICS-CERT if the
operator has an Industrial Control System concern with a cyber security
nexus. Operators can report to ICS-CERT by emailing<EMAIL_ADDRESS>or by calling<PHONE_NUMBER>.
    PHMSA has coordinated with several components within DHS and the
Department of Energy on this Advisory Bulletin.

    Issued in Washington, DC, on December 5, 2016, under authority
delegated in 49 CFR 1.97.
Alan K. Mayberry,
Acting Associate Administrator for Pipeline Safety.
[FR Doc. 2016-29500 Filed 12-8-16; 8:45 am]
 BILLING CODE 4910-60-P


[Federal Register: June 9, 2010 (Volume 75, Number 110)]
[Notices]
[Page 32791-32792]
[DOCID:fr09jn10-70]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0277]

Draft Guidance for Industry: Compliance With Regulations
Restricting the Sale and Distribution of Cigarettes and Smokeless
Tobacco to Protect Children and Adolescents; Availability

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Draft Guidance
for Industry: Compliance with Regulations Restricting the Sale and
Distribution of Cigarettes and Smokeless Tobacco To Protect Children
and Adolescents.'' The draft guidance is intended to help small
entities comply with the final regulations restricting the sale and
distribution of cigarettes and smokeless tobacco in order to protect
children and adolescents.

DATES:  Although you can comment on any guidance at any time (see 21
CFR 10.115(g)(5)), to ensure that the agency considers your comment on
this draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by July 31, 2010.

ADDRESSES:  The draft guidance for industry entitled ``Draft Guidance
for Industry: Compliance with Regulations Restricting the Sale and
Distribution of Cigarettes and Smokeless Tobacco To Protect Children
and Adolescents'' is available on the Internet at http://www.fda.gov/
TobaccoProducts/GuidanceComplianceRegulatoryInformation/default.htm, or
a paper copy may be ordered free of charge by calling 1-877-287-1373.
    Submit electronic comments to http://www.regulations.gov. Submit
written comments to the Division of Dockets Management (HFA-305), Food
and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD
20852. Identify comments with the docket number found in brackets in
the heading of this document.

FOR FURTHER INFORMATION CONTACT:  Kathleen K. Quinn, Center for Tobacco
Products, Food and Drug Administration, 9200 Corporate Blvd.,
Rockville, MD 20850-3229,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    The Family Smoking Prevention and Tobacco Control Act (Tobacco
Control Act) (Public Law 111-31; 123 Stat. 1776) was enacted on June
22, 2009, amending the Federal Food, Drug, and Cosmetic Act (FFDCA) and
providing FDA with the authority to regulate tobacco products. Section
102 of the Tobacco Control Act requires FDA to publish final
regulations regarding cigarettes and smokeless tobacco which are
identical in their provisions to the regulations promulgated by FDA in
1996 (1996 final regulations) on August 28, 1996 (61 FR 44396), with
certain specified exceptions. In the Federal Register of March 19, 2010
(75 FR 13225), FDA published its final regulations entitled
``Regulations Restricting the Sale and Distribution of Cigarettes and
Smokeless Tobacco To

Protect Children and Adolescents,'' at 21 CFR part 1140. The final
regulations apply to manufacturers, distributors, and retailers who
make, distribute, or sell cigarettes or smokeless tobacco products.
    Beginning on June 22, 2010, these Federal regulations will prohibit
retailers from selling cigarettes, cigarette tobacco, or smokeless
tobacco to persons under the age of 18, and will require retailers to
verify the age of all customers under the age of 27 by checking a
photographic identification that includes the bearer's date of birth.
    FDA is announcing the availability of a draft guidance document,
which is intended to help small businesses comply with the requirements
of the new regulations. FDA is soliciting comments on the draft
guidance document and may amend the guidance document periodically as a
result of comments received.

II. Significance of Guidance

    FDA is issuing this draft guidance document consistent with FDA's
good guidance practices regulation (21 CFR 10.115). The draft guidance,
when finalized, will represent the agency's current thinking on
``Compliance with Regulations Restricting the Sale and Distribution of
Cigarettes and Smokeless Tobacco To Protect Children and Adolescents.''
It does not create or confer any rights for or on any person and does
not operate to bind FDA or the public. An alternative approach may be
used if such approach satisfies the requirements of the applicable
statute and regulations.

III. Comments

    The draft guidance is being distributed for comment purposes only
and is not intended for implementation at this time. 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.

IV. Electronic Access

    An electronic version of the guidance document is available on the
Internet at http://www.regulations.gov and http://www.fda.gov/
TobaccoProducts/GuidanceComplianceRegulatoryInformation/default.htm.

    Dated: June 7, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-13922 Filed 6-7-10; 11:15 am]
BILLING CODE 4160-01-S


[Federal Register Volume 86, Number 170 (Tuesday, September 7, 2021)]
[Notices]
[Pages 50114-50115]
[FR Doc No: 2021-19188]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2021-0346; FRL-8720-01-OCSPP]

Agency Information Collection Activities; Proposed Renewal of an
Existing Collection and Request for Comment; Labeling Requirements for
Certain Minimum Risk Pesticides Under FIFRA Section 25(b)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act (PRA), this
document announces the availability of and solicits public comment on
an Information Collection Request (ICR) that EPA is planning to submit
to the Office of Management and Budget (OMB). The ICR, entitled:
``Labeling Requirements for Certain Minimum Risk Pesticides under FIFRA
Section 25(b)'' and identified by EPA ICR No. 2475.04 and OMB Control
No. 2070-0187, represents the renewal of an existing ICR that is
currently approved through April 30, 2022. Before submitting the ICR to
OMB for review and approval under the PRA, EPA is soliciting comments
on specific aspects of the proposed information collection that is
summarized in this document. The ICR and accompanying material are
available in the docket for public review and comment.

DATES: Comments must be received on or before November 8, 2021.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2021-0346, through http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. Additional instructions on commenting or visiting the
docket, along with more information about dockets generally, is
available at http://www.epa.gov/dockets.
    Due to the public health concerns related to COVID-19, the EPA
Docket Center (EPA/DC) and Reading Room is closed to visitors with
limited exceptions. The staff continues to provide remote customer
service via email, phone, and webform. For the latest status
information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Nora Stoner, Mission Support Division
(7101M), Office of Program Support, Office of Chemical Safety and
Pollution Prevention, Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: 202-
564-0355; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. What information is EPA particularly interested in?

    Pursuant to PRA section 3506(c)(2)(A) (44 U.S.C. 3506(c)(2)(A)),
EPA specifically solicits comments and information to enable it to:
    1. Evaluate whether the proposed collection of information is
necessary for the proper performance of the

functions of the Agency, including whether the information will have
practical utility.
    2. Evaluate the accuracy of the Agency's estimates of the burden of
the proposed collection of information, including the validity of the
methodology and assumptions used.
    3. Enhance the quality, utility, and clarity of the information to
be collected.
    4. Minimize the burden of the collection of information on those
who are to respond, including through the use of appropriate automated
electronic, mechanical, or other technological collection techniques or
other forms of information technology, e.g., permitting electronic
submission of responses. In particular, EPA is requesting comments from
very small businesses (those that employ less than 25) on examples of
specific additional efforts that EPA could make to reduce the paperwork
burden for very small businesses affected by this collection.

II. What information collection activity or ICR does this action apply
to?

    Title: Labeling Requirements for Certain Minimum Risk Pesticides
under FIFRA Section 25(b).
    ICR number: EPA ICR No. 2475.04.
    OMB control number: OMB Control No. 2070-0187.
    ICR status: This ICR is currently scheduled to expire on April 30,
2022. 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. The OMB control numbers for EPA's
regulations in title 40 of the Code of Federal Regulations (CFR), after
appearing in the Federal Register when approved, are listed in 40 CFR
part 9, are displayed either by publication in the Federal Register or
by other appropriate means, such as on the related collection
instrument or form, if applicable. The display of OMB control numbers
for certain EPA regulations is consolidated in 40 CFR part 9.
    Abstract: Minimum risk pesticide products are not registered by
EPA, therefore the product information associated with the pesticide
registration process under section 3 of FIFRA are never submitted to
EPA. Labeling requirements are the key component of the minimum risk
exemption since this is the only information that enforcement
authorities have to assess whether or not the product meets the
exemption requirements. While EPA does not review these products, and
therefore a Federal label review is not conducted, to maintain
exemption status, an exempt product's label must meet certain criteria.
The Agency will reach out as required under 5 CFR 1320.8(d)(1), to
representatives from producers of minimum risk pesticide products that
would be subjected to the labeling requirements under 40 CFR 152.25(f).
    Burden statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average 5.5
hours per response. Burden is defined in 5 CFR 1320.3(b).
    The ICR, which is available in the docket along with other related
materials, provides a detailed explanation of the collection activities
and the burden estimate that is only briefly summarized here:
    Respondents/Affected Entities: Entities potentially affected by
this ICR are individuals or entities engaged in activities related to
the registration of pesticide products including manufacturers,
distributers, retailers, and users of minimum risk pesticides.
    Respondent's obligation to respond: Voluntary.
    Estimated total number of potential respondents: 7.
    Frequency of response: One time.
    Estimated total average number of responses for each respondent:
87.
    Estimated total annual burden hours: 478.5 hours.
    Estimated total annual costs: $61,018.45. This includes an
estimated burden cost of $50,576.67 and an estimated cost of $9,963.28
for capital investment or maintenance and operational costs.

III. Are there changes in the estimates from the last approval?

    There is an increase of $26,448.82 labor costs in the total
estimated respondent burden compared with that identified in the ICR
currently approved by OMB. This increase reflects the updated wage
rates, the total labor costs increased from $156,606.53 to $183,055.35.
    In addition, OMB has requested that EPA move towards using the 18-
question format for ICR Supporting Statements used by other federal
agencies and departments and that is based on the submission
instructions established by OMB in 1995, replacing the alternate format
developed by EPA and OMB prior to 1995. The Agency does not expect this
change in format to result in substantive changes to the information
collection activities or related estimated burden and costs.

IV. What is the next step in the process for this ICR?

    EPA will consider the comments received and amend the ICR as
appropriate. The final ICR package will then be submitted to OMB for
review and approval pursuant to 5 CFR 1320.12. EPA will issue another
Federal Register document pursuant to 5 CFR 1320.5(a)(1)(iv) to
announce the submission of the ICR to OMB and the opportunity to submit
additional comments to OMB. If you have any questions about this ICR or
the approval process, please contact the person listed under FOR
FURTHER INFORMATION CONTACT.
    Authority: 44 U.S.C. 3501 et seq.

    Dated: August 27, 2021.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2021-19188 Filed 9-3-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 79, Number 77 (Tuesday, April 22, 2014)]
[Notices]
[Page 22483]
[FR Doc No: 2014-09113]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Numbers: RP14-736-000.
    Applicants: Northwest Pipeline LLC.
    Description: Plymouth Blu Water--Missed In-service Date to be
effective 4/1/2014.
    Filed Date: 4/14/14.
    Accession Number: 20140414-5195.
    Comments Due: 5 p.m. ET 4/28/14.

    Docket Numbers: RP14-737-000.
    Applicants: National Fuel Gas Supply Corporation.
    Description: Volume 2 TOC Update to be effective 5/15/2014.
    Filed Date: 4/15/14.
    Accession Number: 20140415-5023.
    Comments Due: 5 p.m. ET 4/28/14.

    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 5:00
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: April 15, 2014.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2014-09113 Filed 4-21-14; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 202 (Friday, October 22, 2021)]
[Notices]
[Pages 58670-58672]
[FR Doc No: 2021-23074]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-E-1910]

Determination of Regulatory Review Period for Purposes of Patent
Extension; NUBEQA

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for NUBEQA and is publishing
this notice of that determination as required by law. FDA has made the
determination because of the submission of an application to the
Director of the U.S. Patent and Trademark Office (USPTO), Department of
Commerce, for the extension of a patent which claims that human drug
product.

DATES: Anyone with knowledge that any of the dates as published (see
SUPPLEMENTARY INFORMATION) are incorrect may submit either electronic
or written comments and ask for a redetermination by December 21, 2021.
Furthermore, any interested person may petition FDA for a determination
regarding whether the applicant for extension acted with due diligence
during the regulatory review period by

April 20, 2022. See ``Petitions'' in the SUPPLEMENTARY INFORMATION
section for more information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before December 21, 2021. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of December 21, 2021. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

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-2020-E-1910 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; NUBEQA.'' Received comments, those filed
in a timely manner (see ADDRESSES), 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 Sec.  10.20 (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>.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug or biologic product, animal drug product, medical device,
food additive, or color additive) was subject to regulatory review by
FDA before the item was marketed. Under these acts, a product's
regulatory review period forms the basis for determining the amount of
extension an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of USPTO may award
(for example, half the testing phase must be subtracted as well as any
time that may have occurred before the patent was issued), FDA's
determination of the length of a regulatory review period for a human
drug product will include all of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human drug product, NUBEQA
(darolutamide), indicated for the treatment of patients with non-
metastatic castration-resistant prostate cancer. Subsequent to this
approval, the USPTO received a patent term restoration application for
NUBEQA (U.S. Patent No. 8,975,254) from Orion Corporation, and the
USPTO requested FDA's assistance in determining the patent's
eligibility for patent term restoration. In a letter dated May 24,
2021, FDA advised the USPTO that this human drug product had undergone
a regulatory review period and that the approval of NUBEQA represented
the first permitted commercial marketing or use of the product.
Thereafter, the USPTO requested that FDA determine the product's
regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for

NUBEQA is 2,576 days. Of this time, 2,420 days occurred during the
testing phase of the regulatory review period, while 156 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective:
July 13, 2012. FDA has verified the applicant's claim that the date the
investigational new drug application became effective was on July 13,
2012.
    2. The date the application was initially submitted with respect to
the human drug product under section 505 of the FD&C Act: February 26,
2019. FDA has verified the applicant's claim that the new drug
application (NDA) for NUBEQA (NDA 212099) was initially submitted on
February 26, 2019.
    3. The date the application was approved: July 30, 2019. FDA has
verified the applicant's claim that NDA 212099 was approved on July 30,
2019.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its application for patent extension,
this applicant seeks 879 days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec.  60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec.  60.30, including but not limited to: must be timely (see
DATES), must be filed in accordance with Sec.  10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42,
1984.) Petitions should be in the format specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: October 15, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-23074 Filed 10-21-21; 8:45 am]
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[Federal Register: August 16, 2010 (Volume 75, Number 157)]
[Notices]
[Page 49917]
[DOCID:fr16au10-56]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP10-473-000]

PetroLogistics Natural Gas Storage, LLC; Notice of Application

August 3, 2010.
    Take notice that on July 21, 2010, PetroLogistics Natural Gas
Storage, LLC (PetroLogistics), 4470 Bluebonnet Blvd., Baton Rouge,
Louisiana 70809, filed in Docket No. CP10-473-000, an application
pursuant to section 7(c) of the Natural Gas Act (NGA) and Part 157 of
the Commission's regulations, requesting a certificate of public
convenience and necessity to construct the Cavern 24 Expansion Project
in Iberville Parish, Louisiana. Specifically, the Cavern 24 Expansion
Project consists of placing into Commission-jurisdictional service an
existing natural gas salt dome storage cavern; constructing associated
piping, measuring, and appurtenant facilities in order to connect the
cavern to PetroLogistics' existing pipeline; and increasing the maximum
daily deliverability of the storage facility, all as more fully set
forth in the application which is on file with the Commission and open
to public inspection. This filing may also be viewed on the
Commission's Web site at http://www.ferc.gov using the ``eLibrary''
link. Enter the docket number, excluding the last three digits, in the
docket number field to access the document. For assistance, call (866)
208-3676 or TTY,<PHONE_NUMBER>.
    Any questions regarding this application should be directed to
Allen Kirkley, PetroLogistics Natural Gas Storage, LLC, 4470 Bluebonnet
Blvd., Baton Rouge, Louisiana 70809, or by calling<PHONE_NUMBER>
(telephone) or<PHONE_NUMBER> (fax).
    Pursuant to section 157.9 of the Commission's rules, 18 CFR 157.9,
within 90 days of this Notice the Commission staff will either:
complete its environmental assessment (EA) and place it into the
Commission's public record (eLibrary) for this proceeding, or issue a
Notice of Schedule for Environmental Review. If a Notice of Schedule
for Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission staff's issuance of
the final environmental impact statement (FEIS) or EA for this
proposal. The filing of the EA in the Commission's public record for
this proceeding or the issuance of a Notice of Schedule for
Environmental Review will serve to notify Federal and State agencies of
the timing for the completion of all necessary reviews, and the
subsequent need to complete all Federal authorizations within 90 days
of the date of issuance of the Commission staff's FEIS or EA.
    There are two ways to become involved in the Commission's review of
this project. First, any person wishing to obtain legal status by
becoming a party to the proceedings for this project should, on or
before the comment date stated below, file with the Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426, a
motion to intervene in accordance with the requirements of the
Commission's Rules of Practice and Procedure (18 CFR 385.214 or
385.211) and the Regulations under the NGA (18 CFR 157.10). A person
obtaining party status will be placed on the service list maintained by
the Secretary of the Commission and will receive copies of all
documents filed by the applicant and by all other parties. A party must
submit 14 copies of filings made with the Commission and must mail a
copy to the applicant and to every other party in the proceeding. Only
parties to the proceeding can ask for court review of Commission orders
in the proceeding.
    However, a person does not have to intervene in order to have
comments considered. The second way to participate is by filing with
the Secretary of the Commission, as soon as possible, an original and
two copies of comments in support of or in opposition to this project.
The Commission will consider these comments in determining the
appropriate action to be taken, but the filing of a comment alone will
not serve to make the filer a party to the proceeding. The Commission's
rules require that persons filing comments in opposition to the project
provide copies of their protests only to the party or parties directly
involved in the protest.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commenters will be
placed on the Commission's environmental mailing list, will receive
copies of the environmental documents, and will be notified of meetings
associated with the Commission's environmental review process.
Environmental commenters will not be required to serve copies of filed
documents on all other parties. However, the non-party commenters will
not receive copies of all documents filed by other parties or issued by
the Commission (except for the mailing of environmental documents
issued by the Commission) and will not have the right to seek court
review of the Commission's final order.
    Motions to intervene, protests and comments may be filed
electronically via the Internet in lieu of paper; see, 18 CFR
385.2001(a) (1) (iii) and the instructions on the Commission's Web site
under the ``e-Filing'' link. The Commission strongly encourages
electronic filings.
    Comment Date: August 24, 2010.

Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2010-20137 Filed 8-13-10; 8:45 am]
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