[Federal Register Volume 81, Number 32 (Thursday, February 18, 2016)]
[Notices]
[Page 8189]
[FR Doc No: 2016-03329]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Notice of Commission Staff Attendance

    The Federal Energy Regulatory Commission (Commission) hereby gives
notice that members of the Commission's staff will attend the following
meeting related to the Midcontinent Independent System Operator, Inc.
(MISO)--PJM Interconnection, L.L.C. (PJM) Joint and Common Market
Initiative (Docket No. AD14-3-000):

MISO/PJM Joint Stakeholder Meeting--February 18, 2016

    The above-referenced meeting will be held at: PJM Conference &
Training Center, 2750 Monroe Boulevard, Audubon, PA 19403.
    The above-referenced meeting is open to the public.
    Further information may be found at www.pjm.com.
    The discussions at the meeting described above may address matters
at issue in the following proceedings:

Docket Nos. ER16-533, ER16-534, Midcontinent Independent System
Operator, Inc.
Docket Nos. ER16-535, ER16-536, PJM Interconnection, L.L.C.
Docket No. ER16-488, PJM Interconnection, L.L.C.
Docket No. ER16-490, Midcontinent Independent System Operator, Inc.
Docket No. EL13-88, Northern Indiana Public Service Company v.
Midcontinent Independent System Operator, Inc. and PJM Interconnection,
L.L.C.
Docket No. EL11-34, Midcontinent Independent System Operator, Inc.
Docket No. EL14-21, Southwest Power Pool, Inc. v. Midcontinent
Independent System Operator, Inc.
Docket No. EL14-30, Midcontinent Independent System Operator, Inc. v.
Southwest Power Pool, Inc.
Docket No. ER11-1844, Midwest Independent Transmission System Operator,
Inc.
Docket No. ER10-1791, Midwest Independent Transmission System Operator,
Inc.
Docket Nos. ER13-1923, ER13-1938, ER13-1943, ER13-1945, Midcontinent
Independent System Operator, Inc.
Docket Nos. ER13-1924, ER13-1926, ER13-1936, ER13-1944, ER13-1947,
ER15-2200, PJM Interconnection, L.L.C.
Docket Nos. ER13-1937, ER13-1939, Southwest Power Pool, Inc.
Docket No. ER14-1174, Southwest Power Pool, Inc.
Docket No. ER14-1736, Midcontinent Independent System Operator, Inc.
Docket No. ER14-2022, Midcontinent Independent System Operator, Inc.
Docket No. ER14-2445, Midcontinent Independent System Operator, Inc.
Docket No. ER16-56, Midcontinent Independent System Operator, Inc.
Docket No. ER15-2613, PJM Interconnection, L.L.C.
Docket No. ER15-2616, Midcontinent Independent System Operator, Inc.
Docket No. EL15-99, Internal MISO Generation v. Midcontinent
Independent System Operator, Inc.

    For more information, contact John Taber, Office of Energy Policy
and Innovation, Federal Energy Regulatory Commission at<PHONE_NUMBER>
or<EMAIL_ADDRESS>
    Dated: February 10, 2016.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2016-03329 Filed 2-17-16; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 120 (Tuesday, June 23, 2015)]
[Notices]
[Pages 36042-36044]
[FR Doc No: 2015-15401]

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

DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

[Docket No. PHMSA-2015-0140]

Pipeline Safety: Potential for Damage to Pipeline Facilities
Caused by the Passage of Hurricanes

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

ACTION: Notice; Issuance of Advisory Bulletin.

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

SUMMARY: PHMSA is issuing this advisory bulletin to remind owners and
operators of gas and hazardous liquid pipelines of the potential for
damage to pipeline facilities caused by the passage of hurricanes.

ADDRESSES: This document can be viewed on the Office of Pipeline Safety
(OPS) home page at: http://ops.dot.gov.

FOR FURTHER INFORMATION CONTACT: Pipeline operators regulated by PHMSA
should contact the appropriate PHMSA Regional Office. PHMSA's Regional

Offices and their contact information are as follows:
     Eastern Region: Connecticut, Delaware, District of
Columbia, Maine, Maryland, Massachusetts, New Hampshire, New Jersey,
New York, Ohio, Pennsylvania, Rhode Island, Vermont, Virginia, and West
Virginia, call<PHONE_NUMBER>.
     Southern Region: Alabama, Florida, Georgia, Kentucky,
Mississippi, North Carolina, Puerto Rico, South Carolina, and
Tennessee, call<PHONE_NUMBER>.
     Central Region: Illinois, Indiana, Iowa, Kansas, Michigan,
Minnesota, Missouri, Nebraska, North Dakota, South Dakota, and
Wisconsin, call<PHONE_NUMBER>.
     Southwest Region: Arkansas, Louisiana, New Mexico,
Oklahoma, and Texas, call<PHONE_NUMBER>.
     Western Region: Alaska, Arizona, California, Colorado,
Hawaii, Idaho, Montana, Nevada, Oregon, Utah, Washington, and Wyoming,
call<PHONE_NUMBER>.
    Intrastate pipeline operators should contact the appropriate State
pipeline safety authority. A list of State pipeline safety authorities
is provided at: http://www.napsr.org/managers/napsr_state_program_managers2.htm.
    For general information about this notice, contact David Lehman,
Director for Emergency Support and Security,<PHONE_NUMBER> or by email
at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    The purpose of this advisory bulletin is to remind owners and
operators of gas and hazardous liquid pipelines, particularly those
with facilities located in offshore and inland areas, about the serious
safety-related issues that can result from the passage of hurricanes.
Potential damage can occur to offshore platforms and pipelines, onshore
pumping stations, compressor stations, and terminals.
    Operators have a general obligation to identify any conditions that
can adversely affect the operation of their pipelines and to take
appropriate corrective measures upon discovering such conditions.
Specifically, Sec.  192.613 of the gas pipeline safety regulations
states that ``[e]ach operator shall have a procedure for continuing
surveillance of its facilities to determine and take appropriate action
concerning . . . unusual operating and maintenance conditions,'' and
``[i]f a segment of pipeline is determined to be in unsatisfactory
condition but no immediate hazard exists, the operator shall initiate a
program to recondition or phase out the segment involved, or, if the
segment cannot be reconditioned or phased out, reduce the maximum
allowable operating pressure in accordance with Sec.  192.619(a) and
(b).'' Section 195.401(b)(1) of the hazardous liquid pipeline safety
regulations states that ``[w]henever an operator discovers any
condition that could adversely affect the safe operation of its
pipeline system, it must correct the condition within a reasonable
time. However, if the condition is of such a nature that it presents an
immediate hazard to persons or property, the operator may not operate
the affected part of the system until it has corrected the unsafe
condition.'' Section 195.401(b)(2) further states that ``[w]hen an
operator discovers a condition on a pipeline covered under [the
integrity management requirements in] Sec.  195.452, the operator must
correct the condition as prescribed in Sec.  195.452(h).''
    Operators of shallow-water gas and hazardous liquid pipelines in
the Gulf of Mexico and its inlets have a specific obligation to
``prepare and follow a procedure to identify [their] pipelines . . .
that are at risk of being an exposed underwater pipeline or a hazard to
navigation . . . [and to] conduct appropriate underwater inspections .
. . [of those pipelines] based on the identified risk[;]'' and upon
discovering that ``its pipeline is an exposed underwater pipeline or
poses a hazard to navigation,'' to promptly report the location of that
pipeline to the National Response Center, to mark its location, and to
ensure its reburial within a specified time. 49 CFR 192.612, 195.413.
    Hurricanes can adversely affect the operation of a pipeline and
require corrective action under Sec. Sec.  192.613 and 195.401.
Hurricanes also increase the risk of underwater pipelines in the Gulf
of Mexico and its inlets becoming exposed or constituting a hazard to
navigation under Sec. Sec.  192.612 and 195.413. The concentration of
U.S. oil and gas production, processing, and transportation facilities
in the Gulf of Mexico and onshore Gulf Coast means that a significant
percentage of domestic oil and gas production and processing is prone
to disruption by hurricanes.
    In 2005, Hurricanes Katrina and Rita caused significant damage to
the oil and gas production structures. The onshore damage caused a
significant impact in the ability of the oil and gas industry to
respond due to the lack of resources, personnel, and infrastructure, as
well as significant damage to onshore processing facilities and power
supplies. There were significant competing resource needs with the
impacts caused by the devastation of New Orleans and western Louisiana/
eastern Texas shore communities that normally provide the services and
supplies for the industry.

II. Advisory Bulletin (ADB-2015-02)

    To: Owners and operators of gas and hazardous liquid pipeline
systems.
    Subject: Potential for damage to pipeline facilities caused by
hurricanes.
    Advisory: All owners and operators of gas and hazardous liquid
pipelines are reminded that pipeline safety problems can occur from the
passage of hurricanes. Pipeline operators are urged to take the
following actions to ensure pipeline safety:
    1. Identify persons who normally engage in shallow-water commercial
fishing, shrimping, and other marine vessel operations and caution them
that underwater offshore pipelines may be exposed or constitute a
hazard to navigation. Marine vessels operating in water depths
comparable to a vessel's draft or when operating bottom dragging
equipment can be damaged and their crews endangered by an encounter
with an underwater pipeline.
    2. Identify and caution marine vessel operators in offshore
shipping lanes and other offshore areas that deploying fishing nets or
anchors and conducting dredging operations may damage underwater
pipelines, their vessels, and endanger their crews.
    3. After a disruption, operators need to bring offshore and inland
transmission facilities back online, check for structural damage to
piping, valves, emergency shutdown systems, risers and supporting
systems. Aerial inspections of pipeline routes should be conducted to
check for leaks in the transmission systems. In areas where floating
and jack-up rigs have moved and their path could have been over the
pipelines, review possible routes and check for sub-sea pipeline damage
where required.
    4. Operators should take action to minimize and mitigate damages
caused by flooding to gas distribution systems, including the
prevention of overpressure of low pressure and high pressure
distribution systems.
    PHMSA would appreciate receiving information about any damage to
pipeline facilities caused by hurricanes. The Federal pipeline safety
regulations require that operators report certain incidents and
accidents to PHMSA by specific methods. Damage not reported by these
methods may be reported to David Lehman, Director for Emergency Support
and Security,<PHONE_NUMBER> or by email at<EMAIL_ADDRESS>    Chapter 601; 49 CFR 1.97.

    Issued in Washington, DC, on June 18, 2015.
Jeffrey D. Wiese,
Associate Administrator for Pipeline Safety.
[FR Doc. 2015-15401 Filed 6-22-15; 08:45 am]
 BILLING CODE 4910-60-P


[Federal Register Volume 86, Number 33 (Monday, February 22, 2021)]
[Rules and Regulations]
[Pages 10449-10451]
[FR Doc No: 2021-01848]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2020-1037; Project Identifier 2019-SW-077-AD; Amendment
39-21407; AD 2021-03-04]
RIN 2120-AA64

Airworthiness Directives; Airbus Helicopters Deutschland GmbH
Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: The FAA is adopting a new airworthiness directive (AD) for
certain Airbus Helicopters Deutschland GmbH Model EC135P1, EC135P2,
EC135P2+, EC135P3, EC135T1, EC135T2, EC135T2+, and EC135T3 helicopters.
This AD requires removing certain Titanium (Ti) bolts from service and
prohibits installing these Ti-bolts in a critical area. This AD was
prompted by a report of a broken Ti-bolt. The actions of this AD are
intended to address an unsafe condition on these products.

DATES: This AD is effective March 29, 2021.

ADDRESSES: For service information identified in this final rule,
contact Airbus Helicopters, 2701 N Forum Drive, Grand Prairie, TX
75052; telephone<PHONE_NUMBER> or<PHONE_NUMBER>; fax<PHONE_NUMBER>; or at
https://www.airbus.com/helicopters/services/technical-support.html. You
may view the referenced service information at the FAA, Office of the
Regional Counsel, Southwest Region, 10101 Hillwood Pkwy., Room 6N-321,
Fort Worth, TX 76177.

Examining the AD Docket

    You may examine the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2020-
1037; 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 AD, the European Union Aviation Safety Agency (EASA) AD, any
comments received, and other information. The street 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: Katherine Venegas, Aviation Safety
Engineer, Los Angeles ACO, FAA, 3960 Paramount Blvd., Lakewood, CA
90712; telephone<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 by adding an AD that would apply to Airbus Helicopters
Deutschland GmbH Model EC135P1, EC135P2, EC135P2+, EC135P3, EC135T1,
EC135T2, EC135T2+, and EC135T3 helicopters with a Ti-bolt part number
(P/N) L535M2001203 marked with manufacturer monogram ``D'' or with an
illegible manufacturer monogram installed on the forward tail rotor (T/
R) drive shaft. The NPRM published in the Federal Register on November
30, 2020 (85 FR 76490). The NPRM proposed to require removing any
affected Ti-bolt installed on the forward T/R drive shaft from service
and prohibit installing an affected Ti-bolt on the forward T/R drive
shaft of any helicopter. The proposed requirements were intended to
prevent failure of an affected Ti-bolt installed in a critical
location, possibly resulting in reduced control of the helicopter.
    The NPRM was prompted by EASA AD No. 2019-0199, dated August 16,
2019, issued by EASA, which is the Technical Agent for the Member
States of the European Union, to correct an unsafe condition for Airbus
Helicopters Deutschland GmbH (AHD), formerly Eurocopter Deutschland
GmbH, Eurocopter Espa[ntilde]a S.A., Model EC135 P1, EC135 P2, EC135
P2+, EC135 P3, EC135 T1, EC135 T2, EC135 T2+, EC135 T3, EC635 P2+,
EC635 P3, EC635 T1, EC635 T2+, and EC635 T3 helicopters. EASA advises
of a report of a broken Ti-bolt. Subsequent investigation revealed that
an improper heat treatment process was accomplished on a batch of Ti-
bolts, which can lead to hydrogen embrittlement. The investigation also
identified the critical location where these Ti-bolts are installed on
helicopters. According to EASA, this condition, if not detected and
corrected, could lead to failure of an affected Ti-bolt installed in a
critical location, possibly resulting in reduced control of the
helicopter. Accordingly, the EASA AD requires a one-time inspection of
Ti-bolt P/N L535M2001203 marked with

manufacturer monogram ``D'' or with an illegible manufacturer monogram
installed on the forward T/R drive shaft and, depending on the
inspection results, replacing the Ti-bolt. The EASA AD also prohibits
the (re)installation of these Ti-bolts.

Comments

    The FAA gave the public the opportunity to participate in
developing this final rule, but the FAA did not receive any comments on
the NPRM or on the determination of the cost to the public.

FAA's Determination

    These helicopters have been approved by EASA and are approved for
operation in the United States. Pursuant to the FAA's bilateral
agreement with the European Union, EASA has notified the FAA of the
unsafe condition described in its AD. The FAA is issuing this AD after
evaluating all of the information provided by EASA and determining the
unsafe condition exists and is likely to exist or develop on other
helicopters of these same type designs and that air safety and the
public interest require adopting the AD requirements as proposed.

Differences Between This AD and the EASA AD

    The EASA AD applies to Model EC135 P1, EC135 P2, EC135 P2+, EC135
P3, EC135 T1, EC135 T2, EC135 T2+, EC135 T3, EC635 P2+, EC635 P3, EC635
T1, EC635 T2+, and EC635 T3 helicopters and requires inspecting Ti-bolt
P/N L535M2001203 marked with manufacturer monogram ``D'' or with an
illegible manufacturer monogram installed on the forward T/R drive
shaft. This AD applies to Model EC135P1, EC135P2, EC135P2+, EC135P3,
EC135T1, EC135T2, EC135T2+, and EC135T3 helicopters with a Ti-bolt P/N
L535M2001203 marked with manufacturer monogram ``D'' or with an
illegible manufacturer monogram installed on the forward T/R drive
shaft instead. This AD does not apply to Model EC635 P2+, EC635 P3,
EC635 T1, EC635 T2+, or EC635 T3 helicopters because these models are
not FAA type-certificated. The EASA AD requires discarding the affected
Ti-bolts, whereas this AD requires removing the affected Ti-bolts from
service instead.

 Related Service Information

    The FAA reviewed Airbus Helicopters Alert Service Bulletin (ASB)
No. EC135-00A-001, Revision 1, dated September 2, 2019, for Airbus
Helicopters Deutschland GmbH Model EC135 T1, T2, T2+, T3, P1, P2, P2+,
P3, 635 T1, 635 T2+, 635 T3, 635 P2+, and 635 P3 helicopters, and
Airbus Helicopters ASB No. EC135H-00A-001, Revision 1, dated September
2, 2019, for Airbus Helicopters Deutschland GmbH Model EC135, T3H, P3H,
635 T3H, and 635 P3H helicopters. This service information specifies
inspecting the forward T/R drive shaft, distance plate of the 5B-0.50-
2.50P-XN-1 antenna, main rotor controls, FWD connection of ball bearing
control, and AFT connection of ball bearing control and yaw actuator
for the installation of Ti-bolt P/N L535M2001203, EN3308-040020F,
L221M1040201, EN3740-060020F, and EN3308-060020F, marked with
manufacturer monogram ``D'' or an illegible manufacturer monogram. If a
specified Ti-bolt is installed, the service information specifies
replacing the Ti-bolt and discarding the removed Ti-bolt.

Costs of Compliance

    The FAA estimates that this AD affects 326 helicopters of U.S.
Registry. Labor rates are estimated at $85 per work-hour. Based on
these numbers, the FAA estimates that operators may incur the following
costs in order to comply with this AD.
    Replacing a Ti-bolt takes about four work-hours and parts cost
about $82 for an estimated cost of $422 per Ti-bolt.

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 helicopters 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 that 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.

Adoption of 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:

2021-03-04 Airbus Helicopters Deutschland GmbH: Amendment 39-21407;
Docket No. FAA-2020-1037; Project Identifier 2019-SW-077-AD.

(a) Applicability

    This airworthiness directive (AD) applies to Airbus Helicopters
Deutschland GmbH Model EC135P1, EC135P2, EC135P2+, EC135P3, EC135T1,
EC135T2, EC135T2+, and EC135T3 helicopters, certificated in any
category, with a Titanium (Ti) bolt part number L535M2001203 marked
with manufacturer monogram ``D'' or with an illegible manufacturer
monogram installed on the forward tail rotor drive shaft.
    Note 1 to paragraph (a): Helicopters with an EC135P3H
designation are Model EC135P3 helicopters. Helicopters with an
EC135T3H designation are Model EC135T3 helicopters.

(b) Unsafe Condition

    This AD defines the unsafe condition as failure of an affected
Ti-bolt installed in a critical location, possibly resulting in
reduced control of the helicopter.

(c) Effective Date

    This AD becomes effective March 29, 2021.

(d) Compliance

    You are responsible for performing each action required by this
AD within the specified compliance time unless it has already been
accomplished prior to that time.

(e) Required Actions

    (1) Within 50 hours time-in-service or 3 months, whichever
occurs first, remove any Ti-bolt identified in paragraph (a) of this
AD, located on the forward tail rotor drive shaft, from service.
    (2) As of the effective date of this AD, do not install a Ti-
bolt identified in paragraph (a) of this AD on the forward tail
rotor drive shaft of any helicopter.

(f) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Strategic Policy Rotorcraft Section, FAA, may
approve AMOCs for this AD. Send your proposal to: Manager, Strategic
Policy Rotorcraft Section, FAA, 10101 Hillwood Pkwy., Fort Worth, TX
76177; telephone<PHONE_NUMBER>; email<EMAIL_ADDRESS>    (2) For operations conducted under a 14 CFR part 119 operating
certificate or under 14 CFR part 91, subpart K, the FAA suggests
that you notify your principal inspector, or lacking a principal
inspector, the manager of the local flight standards district office
or certificate holding district office, before operating any
aircraft complying with this AD through an AMOC.

(g) Additional Information

    (1) Airbus Helicopters Alert Service Bulletin (ASB) No. EC135-
00A-001 and ASB No. EC135H-00A-001, each Revision 1 and dated
September 2, 2019, which are not incorporated by reference, contain
additional information about the subject of this AD. For service
information identified in this AD, contact Airbus Helicopters, 2701
N. Forum Drive, Grand Prairie, TX 75052; telephone<PHONE_NUMBER> or
800-232-0323; fax<PHONE_NUMBER>; or at https://www.airbus.com/helicopters/services/technical-support.html. You may view a copy of
the service information at the FAA, Office of the Regional Counsel,
Southwest Region, 10101 Hillwood Pkwy, Room 6N-321, Fort Worth, TX
76177.
    (2) The subject of this AD is addressed in European Union
Aviation Safety Agency (EASA) AD No. 2019-0199, dated August 16,
2019. You may view the EASA AD on the internet at https://www.regulations.gov in Docket No. FAA-2020-1037.

(h) Subject

    Joint Aircraft Service Component (JASC) Code: 1430, Fasteners;
and 6510, Tail Rotor Drive Shaft.

    Issued on January 22, 2021.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2021-01848 Filed 2-19-21; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 84, Number 26 (Thursday, February 7, 2019)]
[Notices]
[Pages 2661-2662]
[FR Doc No: 2019-01337]

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

DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket No. FRA-2018-0008-N-13]

Proposed Agency Information Collection Activities; Comment
Request

AGENCY: Federal Railroad Administration (FRA), Department of
Transportation (DOT).

ACTION: Notice of information collection; request for comment.

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

SUMMARY: Under the Paperwork Reduction Act of 1995 (PRA), this notice
announces that FRA is forwarding the Information Collection Request
(ICR) abstracted below to the Office of Management and Budget (OMB) for
review and comment. The ICR describes the information collection and
its expected burden. On September 17, 2018, FRA published a notice
providing a 60-day period for public comment on the ICR.

DATES: Interested persons are invited to submit comments on or before
March 11, 2019.

ADDRESSES: Submit written comments on the ICR to the Office of
Information and Regulatory Affairs, Office of Management and Budget,
725 17th Street NW, Washington, DC 20503, Attention: FRA Desk Officer.
Comments may also be sent via email to OMB at the following address:
<EMAIL_ADDRESS>
FOR FURTHER INFORMATION CONTACT: Mr. Robert Brogan, Information
Collection Clearance Officer, Office of Railroad Safety, Regulatory
Analysis Division, RRS-21, Federal Railroad Administration, 1200 New
Jersey Avenue SE, Room W33-497, Washington, DC 20590 (telephone: (202)
493-6292); or Ms. Kim Toone, Information Collection Clearance Officer,
Office of Administration, Office of Information Technology, RAD-20,
Federal Railroad Administration, 1200 New Jersey Avenue SE, Room W34-
212, Washington, DC 20590 (telephone:<PHONE_NUMBER>).

SUPPLEMENTARY INFORMATION: The PRA, 44 U.S.C. 3501-3520, and its
implementing regulations, 5 CFR part 1320, require Federal agencies to
issue two notices seeking public comment on information collection
activities before OMB may approve paperwork packages. See 44 U.S.C.
3506, 3507; 5 CFR 1320.8 through 1320.12. On September 17, 2018, FRA
published a 60-day notice in the Federal Register soliciting comment on
the ICR for which it is now seeking OMB approval. See 83 FR 47000. FRA
received no comments in response to this notice.
    Before OMB decides whether to approve this proposed collection of
information, it must provide 30 days for public comment. Federal law
requires OMB to approve or disapprove paperwork packages between 30 and
60 days after the 30-day notice is published. 44 U.S.C. 3507(b)-(c); 5
CFR 1320.10(b); see also 60 FR 44978, 44983, Aug. 29, 1995. OMB
believes the 30-day notice informs the regulated community to file
relevant comments and affords the agency adequate time to digest public
comments before it renders a decision. 60 FR 44983, Aug. 29, 1995.
Therefore, respondents should submit their respective comments to OMB
within 30 days of publication to best ensure having their full effect.
    Comments are invited on the following ICR regarding: (1) Whether
the information collection activities are necessary for FRA to properly
execute its functions, including whether the information will have
practical utility; (2) the accuracy of FRA's estimates of the burden of
the information collection activities, including the validity of the
methodology and assumptions used to determine the estimates; (3) ways
for FRA to enhance the quality, utility, and clarity of the information
being collected; and (4) ways to minimize the burden of information
collection activities on the public, including the use of automated
collection techniques or other forms of information technology.
    The summary below describes the ICR that FRA will submit for OMB
clearance as the PRA requires:
    Title: Driver Awareness of Emergency Notification System (ENS)
Signage at Highway-Rail Grade Crossings.
    OMB Control Number: 2130-NEW.
    Abstract: FRA is interested in knowing more about drivers'
awareness and understanding of the ENS signs posted at highway-rail
grade crossings. ENS signs are placed at crossings so that if a driver
encounters a malfunctioning crossing or an unsafe condition at a
crossing the driver can call the number on the sign and use the posted
crossing identification number to report the issue. If a driver were to
become stuck on the tracks, the driver can also call the phone number
displayed on the ENS sign to notify the railroad. This would help the
railroad slow or stop any oncoming train and dispatch individuals who
could help safely remove the stuck vehicle. Drivers may also choose to
call the ENS number if they believe the crossing signage is damaged or
obstructed. The study will help shed light on how drivers react when
crossing infrastructure appears to be malfunctioning or when they
become stuck on or near the crossing. This study will pay particular
attention to whether drivers look for or attempt to make use of the
information on the ENS sign.
    The proposed study will use the FRA Driving Simulator, housed at
the Volpe National Transportation Systems Center, to study driver
behavior, including drivers' potential interaction with the ENS
signage, at a variety of gate types and ENS sign orientations.
    Participants will be asked to drive through a variety of scenarios
to understand their behaviors under certain circumstances. The data
collected in this portion will include information on the vehicle
driver's:
    a. Behavior to determine what a driver does and where the driver
looks when at a crossing equipped with a functioning warning system;
    b. behavior to determine how a driver responds to a malfunctioning
crossing gate (e.g., violated safety signals, turned around and found
another route);
    c. eye fixation locations to determine whether the driver notices
an ENS sign or if the driver's eye fixates long enough to read it, when
crossing warning systems are functioning properly or malfunctioning;
    d. response to an ENS sign to determine whether the driver would
use the information on the sign to address the issue; and
    e. response to an ENS sign to determine whether the driver would
use the information on the sign if the driver becomes stuck on the
tracks.
    This study will evaluate each participant's awareness of the ENS
sign and the purpose it serves as well as the participant's response to
various functioning and malfunctioning highway-rail grade crossing
warning systems.
    Type of Request: Approval of a new collection of information.
    Affected Public: Individuals.
    Form(s): N/A.
    Respondent Universe: 100 individual volunteer drivers.
    Frequency of Submission: One-time.
    Total Estimated Annual Responses: 100.
    Total Estimated Annual Burden: 100 hours.
    Under 44 U.S.C. 3507(a) and 5 CFR 1320.5(b) and 1320.8(b)(3)(vi),
FRA informs all interested parties that it may not conduct or sponsor,
and a respondent is not required to respond to a collection of
information unless it displays a currently valid OMB control number.

    Authority: 44 U.S.C. 3501-3520.

Brett A. Jortland,
Acting Chief Counsel.
[FR Doc. 2019-01337 Filed 2-6-19; 8:45 am]
 BILLING CODE 4910-06-P


[Federal Register: August 11, 2009 (Volume 74, Number 153)]
[Notices]
[Page 40285]
[DOCID:fr11au09-150]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Summary Notice No. PE-2009-34]

Petitions for Exemption; Summary of Petitions Received

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of petitions for exemption received.

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

SUMMARY: This notice contains a summary of certain petitions seeking
relief from specified requirements of 14 CFR. The purpose of this
notice is to improve the public's awareness of, and participation in,
this aspect of FAA's regulatory activities. Neither publication of this
notice nor the inclusion or omission of information in the summary is
intended to affect the legal status of any petition or its final
disposition.

DATES: Comments on petitions received must identify the petition docket
number involved and must be received on or before August 31, 2009.

ADDRESSES: You may send comments identified by Docket Number FAA-2009-
0702 using any of the following methods:
     Government-wide rulemaking Web site: Go to http://
www.regulations.gov and follow the instructions for sending your
comments electronically.
     Mail: Send comments to the Docket Management Facility;
U.S. Department of Transportation, 1200 New Jersey Avenue, SE., West
Building Ground Floor, Room W12-140, Washington, DC 20590.
     Fax: Fax comments to the Docket Management Facility at
202-493-2251.
     Hand Delivery: Bring comments to the Docket Management
Facility 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.
     Docket: To read background documents or comments received,
go to http://www.regulations.gov at any time or to the Docket
Management Facility 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.

SUPPLEMENTARY INFORMATION: We will post all comments we receive,
without change, to http://www.regulations.gov, including any personal
information you provide. Using the search function of our docket Web
site, anyone can find and read the comments received into any of our
dockets, including the name of the individual sending the comment (or
signing the comment for an association, business, labor union, etc.).
You may review DOT's complete Privacy Act Statement in the Federal
Register published on April 11, 2000 (65 FR 19477-78).

FOR FURTHER INFORMATION CONTACT: Tyneka Thomas<PHONE_NUMBER> or Ralen
Gao<PHONE_NUMBER>, Office of Rulemaking, Federal Aviation
Administration, 800 Independence Avenue, SW., Washington, DC 20591.
    This notice is published pursuant to 14 CFR 11.85.

    Issued in Washington, DC, on August 5, 2009.
Pamela Hamilton-Powell,
Director, Office of Rulemaking.

Petitions for Exemption

    Docket No.: FAA-2009-0702.
    Petitioner: Mercy Medical Airlift, Angel Flight Mid-Atlantic and
Airlift Hope of America.
    Section of 14 CFR Affected: 14 CFR 61.113(c).
    Description of Relief Sought: Mercy Medical Airlift, Angel Flight
Mid-Atlantic and Airlift Hope of America seek relief from Sec.
61.113(c) to allow for reimbursement of volunteer pilots for fuel costs
incurred in conducting charitable flights.

[FR Doc. E9-19112 Filed 8-10-09; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register: August 11, 2010 (Volume 75, Number 154)]
[Rules and Regulations]
[Page 48582-48585]
[DOCID:fr11au10-12]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 52 and 70

[EPA-R07-OAR-2009-0913; FRL-9186-5]

Approval and Promulgation of Implementation Plans and Operating
Permits Program; State of Nebraska

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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

SUMMARY: EPA is taking direct final action to approve revisions to the
State Implementation Plan (SIP) and Operating Permits Program to revise
the state definition of volatile organic compounds; clarify language
and incorporate rules related to construction permits to incorporate
application fees and include a mechanism to use construction permits to
accomplish other permitting needs; and clarify language related to open
fires and explicitly include an exemption for fires used for religious
activities. Approval of these revisions will ensure consistency between
the state and Federally-approved rules.

DATES: This direct final rule will be effective October 12, 2010,
without further notice, unless EPA receives adverse comment by
September 10, 2010. If adverse comment is received, EPA will publish a
timely withdrawal of the direct final rule in the Federal Register
informing the public that the rule will not take effect.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R07-
OAR-2009-0913, by one of the following methods:
    1. www.regulations.gov. Follow the on-line instructions for
submitting comments.
    2. E-mail<EMAIL_ADDRESS>    3. Mail or Hand Delivery: Chrissy Wolfersberger, Environmental
Protection Agency, Air Planning and Development Branch, 901 North 5th
Street, Kansas City, Kansas 66101.
    Instructions: Direct your comments to Docket ID No. EPA-R07-OAR-
2009-0913. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit through www.regulations.gov or e-
mail information that you consider to be CBI or otherwise protected.
The

www.regulations.gov Web site is an ``anonymous access'' system, which
means EPA will not know your identity or contact information unless you
provide it in the body of your comment. If you send an e-mail comment
directly to EPA without going through www.regulations.gov, your e-mail
address will be automatically captured and included as part of the
comment that is placed in the public docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, i.e., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available either electronically in www.regulations.gov or
in hard copy at the Environmental Protection Agency, Air Planning and
Development Branch, 901 North 5th Street, Kansas City, Kansas 66101.
The Regional Office's official hours of business are Monday through
Friday, 8 to 4:30 excluding Federal holidays. The interested persons
wanting to examine these documents should make an appointment with the
office at least 24 hours in advance.

FOR FURTHER INFORMATION CONTACT: Chrissy Wolfersberger at (913) 551-
7864, or by e-mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document ``we,'' ``us,'' or
``our'' refer to EPA. This section provides additional information by
addressing the following questions:

What is being addressed in this document?
What action is EPA taking?
What does Federal approval of a state regulation mean to me?

What is being addressed in this document?

    EPA is approving revisions to the Nebraska SIP and Operating
Permits Program which revise the state definition of volatile organic
compounds; incorporate rules related to construction permit application
fees and include a mechanism to use construction permits to accomplish
other permitting needs; and clarify language related to open fires.
    Changes to Chapter 1 revise the definition of volatile organic
compounds (VOCs) to adopt changes that EPA made on November 29, 2004.
In the first action (69 FR 69298), EPA added four chemicals to the list
of excluded compounds at 40 CFR 51.100(s)(1), on the basis that these
compounds make a negligible contribution to tropospheric ozone
formation. These are: 1,1,1,2,2,3,3-heptafluoro-3-methoxy-propane;3-
ethoxy-1,1,1,2,3,4,4,5,5,6,6,6-dodecafluoro-2-(trifluoromethyl) hexane;
1,1,1,2,3,3,3-heptafluoropropane; and Methyl formate.
    In the second action (69 FR 69304), EPA modified the definition of
VOC at 40 CFR 51.100(s)(5) to exclude t-butyl acetate as a VOC for
purposes of VOC emission limitations or VOC content requirements. While
EPA determined that t-butyl acetate has a negligible contribution to
tropospheric ozone formation, and need not be considered in determining
source compliance with restrictions on VOC emissions, it also concluded
that the compound should still be subject to all recordkeeping,
emissions reporting, modeling, and inventory VOC requirements. The EPA
final rule was effective December 29, 2004. The Nebraska regulation
does not retain the recordkeeping, emissions reporting, modeling, and
inventory VOC requirements.
    EPA has communicated with the state regarding this issue, and
expects that Nebraska will revise its rule to retain the recordkeeping,
emissions reporting, modeling, and inventory VOC requirements specified
in the federal rule for sources using t-butyl acetate. Pending the
state's revision of the rule, EPA is not approving the current
submittal as it relates to t-butyl acetate. EPA is, however, approving
the revision as it relates to the other compounds discussed above.
    Changes to Chapter 17, construction permits, clarify various terms
in the regulation, add cross-references, and delete redundant language.
Additionally, Chapter 17, 003.01 adopts into Title 129 the construction
permit application fee structure adopted by the Nebraska Legislature in
2004 at Neb. Rev. Stat. Sec.  81-1505.06. EPA had determined that these
primarily administrative changes are consistent with Federal
requirements.
    Changes to Chapter 17, 015 delineates the construction permit
process to be used as a vehicle to accomplish other permitting needs
when a construction permit is not actually required, including to
establish enforceable limits to avoid otherwise applicable regulatory
provisions, or to modify existing construction permits to incorporate
modifications that cannot be processed otherwise. While EPA is
approving this regulatory change as part of this SIP submission as
consistent with EPA requirements, it should be noted that if this
provision is used to establish requirements relating to another
regulatory program required to be included in the SIP, such as a best
available retrofit technology requirement to address Regional Haze,
Nebraska would need to submit such requirements to EPA for SIP
approval, in order to meet the requirements of the particular
regulatory program. Therefore, EPA approval of this regulation does not
imply approval of permit requirements which may be issued under the
regulation.
    Changes to Chapter 30 clarify language related to open fires,
exemptions, and permits. Additionally, Chapter 30, 002.01 expands
allowable exceptions to the Nebraska Department of Environmental
Quality open fire ban to include fires set solely for religious
activities. According to the state's documentation, this change was
intended to end confusion about the allowability of fires used in
Native American sweat lodge ceremonies in those areas where the state
has jurisdiction. EPA believes that fires set solely for religious
purposes are similar in terms of size, frequency, and emissions to
fires set for recreational purposes, which are already exempted from
the open fire ban. Therefore, this change is considered a
clarification, and it is not expected to result in additional emissions
increases or a SIP relaxation.
    Changes to Chapter 30, 002.08 alter the wording to state that
burning materials not authorized under a burn permit may result in
withdrawal of the permit. The existing wording stating that burning
unauthorized materials ``will result in immediate withdrawal of the
permit'' is inconsistent with normal state enforcement procedures,
which allow for case-by-case discretion. EPA notes that, in any event,
burning of material not authorized under the permit would not be exempt
from the open burning ban in the rule, and would, therefore, be a
violation of the rule. Therefore, the change regarding withdrawal of
permits does not affect the enforceability of the rule. EPA is

approving the rule revision on this basis.

What action is EPA taking?

    With the exception of the exemption of t-butyl acetate as discussed
above, we are taking final action to approve revisions to the Nebraska
SIP and Operating Permits Program. Approval of this revision will
ensure consistency between the state and the Federally-approved rules.
EPA has determined that these changes will not relax the SIP or
adversely impact air emissions and will not substantively change the
operating permits program.
    We are processing this action as a direct final action because the
revisions make noncontroversial changes to the existing rules.
Therefore, we do not anticipate any adverse comments. Please note that
if EPA receives adverse comment on part of this rule and if that part
can be severed from the remainder of the rule, EPA may adopt as final
those parts of the rule that are not the subject of an adverse comment.

What does Federal approval of a state regulation mean to me?

    Enforcement of the state regulation before and after it is
incorporated into the Federally-approved SIP is primarily a state
responsibility. However, after the regulation is Federally approved, we
are authorized to take enforcement action against violators. Citizens
are also offered legal recourse to address violations as described in
section 304 of the CAA.

Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely approves state law as meeting Federal requirements and
does not impose additional requirements beyond those imposed by state
law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this rule does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian country located in
the state, and EPA notes that it will not impose substantial direct
costs on tribal governments or preempt tribal law.
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by October 12, 2010. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and shall not postpone the effectiveness of such rule or
action. Parties with objections to this direct final rule are
encouraged to file a comment in response to the parallel notice of
proposed rulemaking for this action published in the proposed rules
section of today's Federal Register, rather than file an immediate
petition for judicial review of this direct final rule, so that EPA can
withdraw this direct final rule and address the comment in the proposed
rulemaking. This action may not be challenged later in proceedings to
enforce its requirements. (See section 307(b)(2).)

List of Subjects

40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide,
Incorporation by reference, Intergovernmental relations, Nitrogen
dioxide, Ozone, Particulate matter, Reporting and recordkeeping
requirements, Volatile organic compounds.

40 CFR Part 70

    Administrative practice and procedure, Air pollution control,
Intergovernmental relations, Operating permits, Reporting and
recordkeeping requirements.

    Dated: July 21, 2010.
William Rice,
Acting Regional Administrator, Region 7.

0
Chapter I, Title 40 of the Code of Federal Regulations is amended as
follows:

PART 52--[AMENDED]

0
1. The authority citation for Part 52 continues to read as follows:

    Authority:  42 U.S.C. 7401 et seq.

Subpart CC--Nebraska

0
2. In Sec.  52.1420(c) the table is amended by revising the entries for
129-1, 129-17, and 129-30 to read as follows:

Sec.  52.1420  Identification of plan.

* * * * *
    (c) * * *

                                        EPA-Approved Nebraska Regulations
----------------------------------------------------------------------------------------------------------------
                                                          State
       Nebraska  citation                Title          effective      EPA approval date         Explanation
                                                          date
----------------------------------------------------------------------------------------------------------------
                                                STATE OF NEBRASKA
                                       Department of Environmental Quality
                                   Title 129--Nebraska Air Quality Regulations
----------------------------------------------------------------------------------------------------------------
129-1...........................  Definitions........     9/25/05  8/11/10 [insert FR page   Requirements for t-
                                                                    number where the          butyl acetate are
                                                                    document begins].         still in effect.

                                                  * * * * * * *
129-17..........................  Construction            9/25/05  8/11/10 [insert FR page   ...................
                                   Permits--When                    number where the
                                   Required.                        document begins].

                                                  * * * * * * *
129-30..........................  Open Fires,             9/25/05  8/11/10 [insert FR page   ...................
                                   Prohibited;                      number where the
                                   Exceptions.                      document begins].

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *

PART 70--[AMENDED]

0
3. The authority citation for Part 70 continues to read as follows:

    Authority:  42 U.S.C. 7401 et seq.

Appendix A--[Amended]

0
4. Appendix A to Part 70 is amended by adding paragraph (j) under the
heading ``Nebraska; City of Omaha; Lincoln-Lancaster County Health
Department'' to read as follows:

Appendix A to Part 70--Approval Status of State and Local Operating
Permits Programs

* * * * *

Nebraska; City of Omaha; Lincoln-Lancaster County Health Department

* * * * *
    (j) The Nebraska Department of Environmental Quality approved a
revision to NDEQ Title 129, Chapter 1 on June 2, 2005, which became
effective September 25, 2005. This revision was submitted on May 27,
2009. We are approving this program revision effective October 12,
2010.
* * * * *
[FR Doc. 2010-19566 Filed 8-10-10; 8:45 am]
BILLING CODE 6560-50-P


A - 18

APPENDIX 3
Alternative Analysis of Weight and Length in the Case of Late Stage Development
Exceeding 20% of Tadpoles in One Or More Concentration(s)
If an increased number of tadpoles show development beyond stage 60 (≥20%) in one
or more nominal concentration(s), then a two-factor ANOVA with a nested variance
structure should be undertaken on all tadpoles to assess growth effects due to chemical
treatments while taking into account the effect of late stage development on growth.
The proposal is to use all data but take into account the effect of late stage
development. This can be done with a two-factor ANOVA with a nested variance
structure.  Define LateStage=’Yes’ for an animal if its developmental stage is 61 or
greater.  Otherwise, define LateStage=’No’. Then a two-factor ANOVA with
concentration and LateStage and their interaction can be done, with Rep(Conc) a
random factor and Tadpole(Rep) another random effect.  This still treats the rep as the
unit of analysis and gives essentially the same results as a weighted analysis of
rep*latestage means, weighted by the number of animals per mean.  If the data violate
the normality or variance homogeneity requirements of ANOVA, then a normalized
rank-order transform can be done to remove that objection.
In addition to the standard ANOVA F-tests for the effects of CONC, LateStage, and their
interactions, the interaction F-test can be “sliced” into two additional ANOVA F-tests,
one on the mean responses across concentrations for LateStage=’No’ and another on
the mean responses across concentrations for LateStage=’Yes.’  Further comparisons
of treatment means against controls are done within each level of LateStage.  A trend-
type analysis can be done using appropriate contrasts or simple pairwise comparisons
can be done if there is evidence of non-monotone dose-response within a level of the
LateStage variable.  A Bonferroni-Holm adjustment to the p-values is made only if the
corresponding F-slice is not significant.  This can be done in SAS and, presumably,
other statistical software packages.  Complications can arise when there are no late
stage animals in some concentrations, but these situations can be handled in a straight-
forward fashion.
A - 19


[Federal Register Volume 87, Number 44 (Monday, March 7, 2022)]
[Proposed Rules]
[Pages 12630-12631]
[FR Doc No: 2022-04721]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2022-0162; Airspace Docket No. 22-AAL-12]
RIN 2120-AA66

Proposed Revocation of Colored Federal Airway Green 15 (G-15);
St. Mary's, AK

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: This action proposes to revoke Colored Federal airway Green 15
(G-15) due to the decommissioning of St. Mary's, AK, (SMA) and Takotna
River, AK, (VTR) Non-directional Beacons (NDB).

DATES: Comments must be received on or April 21, 2022.

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:
(800) 647-5527, or<PHONE_NUMBER>. You must identify FAA Docket No.
FAA-2022-0162; Airspace Docket No. 22-AAL-12 at the beginning of your
comments. You may also submit comments through the internet at https://www.regulations.gov.
    FAA Order JO 7400.11F, 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
Rules and Regulations Group, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783. FAA Order JO 7400.11F is also available for inspection at the
National Archives and Records Administration (NARA). For information on
the availability of FAA Order JO 7400.11F at NARA, email:
[email protected] or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.

FOR FURTHER INFORMATION CONTACT: Christopher McMullin, Rules and
Regulations Group, Office of Policy, Federal Aviation Administration,
800 Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783.

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
the 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 modify the route structure as necessary to
preserve the safe and efficient flow of air traffic within the National
Airspace System (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 (FAA Docket No.
FAA-2022-0162; Airspace Docket No. 22-AAL-12) and be submitted in
triplicate to the Docket Management Facility (see ADDRESSES section for
address and phone number). You may also submit comments through the
internet at https://www.regulations.gov.
    Commenters wishing the FAA to acknowledge receipt of their comments
on this action must submit with those comments a self-addressed,
stamped postcard on which the following statement is made: ``Comments
to FAA Docket No. FAA-2022-0162; Airspace Docket No. 22-AAL-12.'' The
postcard will be date/time stamped and returned to the commenter.
    All communications received on or before the specified comment
closing date will be considered before taking action on the proposed
rule. The proposal contained in this action may be changed in light of
comments received. All comments submitted will be available for
examination in the public docket both before and after the comment
closing date. A report summarizing each substantive public contact with
FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability of NPRM

    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 ADDRESSES section for 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 office of the Operations Support Group, Western
Service Center, Federal Aviation Administration, 2200 South 216th St.,
Des Moines, WA 98198.

Availability and Summary of Documents for Incorporation by Reference

    This document proposes to amend FAA Order JO 7400.11F, Airspace
Designations and Reporting Points,

dated August 10, 2021, and effective September 15, 2021. FAA Order JO
7400.11F is publicly available as listed in the ADDRESSES section of
this document. FAA Order JO 7400.11F lists Class A, B, C, D, and E
airspace areas, air traffic service routes, and reporting points.

Background

    The aviation industry/users have indicated a desire for the FAA to
transition the Alaskan en route navigation structure away from the
dependency on NDBs. The advances in technology have allowed for
alternate navigation methods to support decommissioning of high cost
ground navigation equipment. The FAA has included SMA and VTR on their
schedule to be decommissioned effective February 23, 2023. A non-
rulemaking study was conducted in 2021 in accordance with FAA Order JO
7400.2, Procedures for Handling Airspace Matters. As a result, the FAA
received no objections to its removal.
    Colored Federal airway G-15 is dependent upon SMA and VTR and will
result in the airway being unusable once the decommissioning occurs.
The FAA is proposing to revoke G-15 as a result. To mitigate the loss
of G-15, the FAA has a planned United States Navigation (RNAV) route,
T-286, and VHF Omnidirectional Radar (VOR) Federal airway V-510 which
overlays the segment of the route between the Anvik Airport and the
McGrath Airport in Alaska.

The Proposal

    The FAA is proposing an amendment to 14 CFR part 71 to revoke
Colored Federal airway G-15 due to the decommissioning of SMA and VTR.
    Colored Federal airway G-15 currently navigates between the St.
Mary's, AK, NDB and the Takotna River, AK, NDB. The FAA proposes to
revoke G-15 in its entirety.
    Colored Federal airways are published in paragraph 6009(a) of FAA
Order JO 7400.11F dated August 10, 2021 and effective September 15,
2021, which is incorporated by reference in 14 CFR 71.1. The Colored
Federal airway listed in this document would be published subsequently
in FAA Order JO 7400.11.
    FAA Order JO 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 proposed regulation only involves
an established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore: (1) Is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under
Department of Transportation (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 proposed rule,
when promulgated, will not have a significant economic impact on a
substantial number of small entities under the criteria of the
Regulatory Flexibility Act.

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

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

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

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 JO
7400.11F, Airspace Designations and Reporting Points, dated August 10,
2021, and effective September 15, 2021, is amended as follows:

Paragraph 6009(a) Colored Federal Airways.

* * * * *

G-15 [Remove]

* * * * *

    Issued in Washington, DC, on March 2, 2022.
Michael R. Beckles,
Manager, Rules and Regulations Group.
[FR Doc. 2022-04721 Filed 3-4-22; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: March 7, 2007 (Volume 72, Number 44)]
[Notices]
[Page 10194]
[DOCID:fr07mr07-70]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP07-307-000]

Columbia Gas Transmission Corporation; Notice of Tariff Filing
and Non-Conforming Service Agreements

February 28, 2007.
    Take notice that on February 23, 2007 Columbia Gas Transmission
Corporation (Columbia) tendered for filing as part of its FERC Gas
Tariff, Second Revised Volume No. 1, Fifteenth Revised Sheet No. 500B,
with a proposed effective date of March 5, 2007.
    Columbia also tendered for filing the following Service Agreements
for consideration and approval:

FTS Service Agreement No. 91904, between Columbia Gas Transmission
Corporation and Hess Corporation, dated February 20, 2007.
FTS Service Agreement No. 91903, between Columbia Gas Transmission
Corporation and Hess Corporation, dated February 20, 2007.

    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed in accordance with the provisions of
Section 154.210 of the Commission's regulations (18 CFR 154.210).
Anyone filing an intervention or protest must serve a copy of that
document on the Applicant. Anyone filing an intervention or protest on
or before the intervention or protest date need not serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible 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. E7-3981 Filed 3-6-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 229 (Thursday, December 2, 2021)]
[Rules and Regulations]
[Pages 68398-68399]
[FR Doc No: 2021-26200]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 876

[Docket No. FDA-2021-N-0285]

Medical Devices; Gastroenterology-Urology Devices; Classification
of the Esophageal Tissue Characterization System

AGENCY: Food and Drug Administration, Department of Health and Human
Services (HHS).

ACTION: Final amendment; final order.

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

SUMMARY: The Food and Drug Administration (FDA or we) is classifying
the esophageal tissue characterization system into class II (special
controls). The special controls that apply to the device type are
identified in this order and will be part of the codified language for
the esophageal tissue characterization system's classification. We are
taking this action because we have determined that classifying the
device into class II (special controls) will provide a reasonable
assurance of safety and effectiveness of the device. We believe this
action will also enhance patients' access to beneficial innovative
devices.

DATES: This order is effective December 2, 2021. The classification was
applicable on December 23, 2019.

FOR FURTHER INFORMATION CONTACT: Pramodh Kariyawasam, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm. 2536, Silver Spring, MD 20993-0002,
301-348-1911, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the esophageal tissue
characterization system as class II (special controls), which we have
determined will provide a reasonable assurance of safety and
effectiveness. In addition, we believe this action will enhance
patients' access to beneficial innovation, by placing the device into a
lower device class than the automatic class III assignment.
    The automatic assignment of class III occurs by operation of law
and without any action by FDA, regardless of the level of risk posed by
the new device. Any device that was not in commercial distribution
before May 28, 1976, is automatically classified as, and remains
within, class III and requires premarket approval unless and until FDA
takes an action to classify or reclassify the device (see 21 U.S.C.
360c(f)(1)). We refer to these devices as ``postamendments devices''
because they were not in commercial distribution prior to the date of
enactment of the Medical Device Amendments of 1976, which amended the
Federal Food, Drug, and Cosmetic Act (FD&C Act).
    FDA may take a variety of actions in appropriate circumstances to
classify or reclassify a device into class I or II. We may issue an
order finding a new device to be substantially equivalent under section
513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a predicate device that
does not require premarket approval. We determine whether a new device
is substantially equivalent to a predicate device by means of the
procedures for premarket notification under section 510(k) of the FD&C
Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807).
    FDA may also classify a device through ``De Novo'' classification,
a common name for the process authorized under section 513(f)(2) of the
FD&C Act. Section 207 of the Food and Drug Administration Modernization
Act of 1997 established the first procedure for De Novo classification
(Pub. L. 105-115). Section 607 of the Food and Drug Administration
Safety and Innovation Act modified the De Novo application process by
adding a second procedure (Pub. L. 112-144). A device sponsor may
utilize either procedure for De Novo classification.
    Under the first procedure, the person submits a 510(k) for a device
that has not previously been classified. After receiving an order from
FDA classifying the device into class III under section 513(f)(1) of
the FD&C Act, the person then requests a classification under section
513(f)(2). Under the second procedure, rather than first submitting a
510(k) and then a request for classification, if the person determines
that there is no legally marketed device upon which to base a
determination of substantial equivalence, that person requests a
classification under section 513(f)(2) of the FD&C Act. Under either
procedure for De Novo classification, FDA is required to classify the
device by written order within 120 days. The classification will be
according to the criteria under section 513(a)(1) of the FD&C Act.
Although the device was automatically placed within class III, the De
Novo classification is considered to be the initial classification of
the device.
    When FDA classifies a device into class I or II via the De Novo
process, the device can serve as a predicate for future devices of that
type, including for 510(k)s (see 21 U.S.C. 360c(f)(2)(B)(i)). As a
result, other device sponsors do not have to submit a De Novo request
or premarket approval application to market a substantially equivalent
device (see 21 U.S.C. 360c(i), defining ``substantial equivalence'').
Instead, sponsors can use the less-burdensome 510(k) process, when
necessary, to market their device.

II. De Novo Classification

    On December 17, 2018, Diversatek Healthcare Inc. submitted a
request for De Novo classification of the Mucosal Integrity
Conductivity Test System. FDA reviewed the request in order to classify
the device under the criteria for classification set forth in section
513(a)(1) of the FD&C Act.
    We classify devices into class II if general controls by themselves
are insufficient to provide reasonable assurance of safety and
effectiveness, but there is sufficient information to establish special
controls that, in combination with the general controls, provide
reasonable assurance of the safety and effectiveness of the device for
its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the
information submitted in the request, we determined that the device can
be classified into class II with the establishment of special controls.
FDA has determined that these special controls, in addition to the
general controls, will provide reasonable assurance of the safety and
effectiveness of the device.
    Therefore, on December 23, 2019, FDA issued an order to the
requester classifying the device into class II. In this final order,\1\
FDA is codifying the classification of the device by adding 21 CFR
876.1450. We have named the generic type of device esophageal tissue
characterization system, and it is identified as a device intended for
obtaining measurements of electrical properties within esophageal
tissue.
---------------------------------------------------------------------------

    \1\ FDA notes that the ``ACTION'' caption for this final order
is styled as ``Final amendment; final order,'' rather than ``Final
order.'' Beginning in December 2019, this editorial change was made
to indicate that the document ``amends'' the Code of Federal
Regulations. The change was made in accordance with the Office of
Federal Register's (OFR) interpretations of the Federal Register Act
(44 U.S.C. chapter 15), its implementing regulations (1 CFR 5.9 and
parts 21 and 22), and the Document Drafting Handbook.
---------------------------------------------------------------------------

    FDA has identified the following risks to health associated
specifically with this type of device and the measures required to
mitigate these risks in table 1.

 Table 1--Esophageal Tissue Characterization System Risks and Mitigation
                                Measures
------------------------------------------------------------------------
            Identified risks                   Mitigation measures
------------------------------------------------------------------------
Device malfunction related to:           Nonclinical performance
 Breaking                         testing; Shelf life testing;
 Fractures                        Software verification,
 Unintentional separation of      validation, and hazard
 components                               analysis; and Labeling.
 Inaccurate reading
 Failure to sense
 Endoscope incompatibility
Adverse tissue reaction................  Biocompatibility evaluation.
Electrical shock and electrical          Electrical safety testing,
 interference from other devices.         Electromagnetic compatibility
                                          (EMC) testing, and Labeling.
Procedural risks (which may include      Labeling.
 procedures of endoscopy with sedation).
Infection/cross-contamination..........  Reprocessing validation,
                                          Labeling.
------------------------------------------------------------------------

    FDA has determined that special controls, in combination with the
general controls, address these risks to health and provide reasonable
assurance of safety and effectiveness. For a device to fall within this
classification, and thus avoid automatic classification in class III,
it would have to comply with the special controls named in this final
order. The necessary special controls appear in the regulation codified
by this order. This device is subject to premarket notification
requirements under section 510(k) of the FD&C Act.

III. Analysis of Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

IV. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to
previously approved collections of information found in other FDA
regulations and guidance. These collections of information are subject
to review by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections
of information in the guidance document ``De Novo Classification
Process (Evaluation of Automatic Class III Designation)'' have been
approved under OMB control number 0910-0844; the collections of
information in 21 CFR part 814, subparts A through E, regarding
premarket approval, have been approved under OMB control number 0910-
0231; the collections of information in part 807, subpart E, regarding
premarket notification submissions, have been approved under OMB
control number 0910-0120; the collections of information in 21 CFR part
820, regarding quality system regulation, have been approved under OMB
control number 0910-0073; and the collections of information in 21 CFR
part 801, regarding labeling, have been approved under OMB control
number 0910-0485.

List of Subjects in 21 CFR Part 876

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
876 is amended as follows:

PART 876--GASTROENTEROLOGY-UROLOGY DEVICES

0
1. The authority citation for part 876 continues to read as follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
2.Add Sec.  876.1450 to subpart B to read as follows:

Sec.  876.1450  Esophageal tissue characterization system.

    (a) Identification. An esophageal tissue characterization system is
a device intended for obtaining measurements of electrical properties
within esophageal tissue.
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) All patient contacting components of the device must be
demonstrated to be biocompatible.
    (2) Performance testing must demonstrate the device can accurately
measure the designated electrical characteristics.
    (3) Mechanical safety testing must demonstrate that the device will
withstand forces encountered during use.
    (4) Software verification, validation, and hazard analysis must be
performed.
    (5) Electromagnetic compatibility and electrical safety, mechanical
safety, and thermal safety of the device must be performed.
    (6) Performance data must validate the reprocessing instructions
for any reusable components of the device.
    (7) Labeling must include:
    (i) Specific instructions regarding the proper placement and use of
the device;
    (ii) Instructions for reprocessing of any reusable components; and
    (iii) An expiration date for single use components.

    Dated: November 26, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-26200 Filed 12-1-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 80, Number 44 (Friday, March 6, 2015)]
[Rules and Regulations]
[Page 12081]
[FR Doc No: 2015-05184]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520

Oral Dosage Form New Animal Drugs

CFR Correction

    In Title 21 of the Code of Federal Regulations, Parts 500 to 599,
revised as of April 1, 2014, on page 167, in Sec.  520.1193, in
paragraph (b)(2), revise ``051311 and 059130'' to read ``000859 and
051311''.

[FR Doc. 2015-05184 Filed 3-5-15; 8:45 am]
 BILLING CODE 1505-01-D