[Federal Register Volume 83, Number 214 (Monday, November 5, 2018)]
[Proposed Rules]
[Pages 55299-55303]
[FR Doc No: 2018-23689]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2018-0903; Product Identifier 2018-NM-113-AD]
RIN 2120-AA64

Airworthiness Directives; Airbus SAS Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to supersede Airworthiness Directive (AD) 2016-19-
14, which applies to certain Airbus SAS Model A318 and A319 series
airplanes; Model A320-211, -212, -214, -231, -232, and -233 airplanes;
and Model A321-111, -112, -131, -211, -212, -213, -231, and -232
airplanes. AD 2016-19-14 requires repetitive inspections for cracking
of the 10VU rack fitting lugs, and repair of any cracking. Since we
issued AD 2016-19-14, we have determined that the unsafe condition may
exist on additional airplanes. This proposed AD continues to require
repetitive inspections for cracking of the 10VU rack fitting lugs, and
repair of any cracking. This proposed AD would also add airplanes to
the applicability. We are proposing this AD to address the unsafe
condition on these products.

DATES: We must receive comments on this proposed AD by December 20,
2018.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For service information identified in this NPRM, contact Airbus
SAS, Airworthiness Office--EIAS, Rond-Point Emile Dewoitine No: 2,
31700 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61
93 44 51; email [email protected]; internet http://www.airbus.com. You may view this referenced service

information at the FAA, Transport Standards Branch, 2200 South 216th
St., Des Moines, WA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-
0903; 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 NPRM, the regulatory evaluation, any comments received, and other
information. The street address for Docket Operations (phone 800-647-
5527) is in the ADDRESSES section. Comments will be available in the AD
docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Sanjay Ralhan, Aerospace Engineer,
International Section, Transport Standards Branch, FAA, 2200 South
216th St., Des Moines, WA 98198; telephone and fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under the ADDRESSES section. Include ``Docket No. FAA-2018-0903;
Product Identifier 2018-NM-113-AD'' at the beginning of your comments.
We specifically invite comments on the overall regulatory, economic,
environmental, and energy aspects of this proposed AD. We will consider
all comments received by the closing date and may amend this proposed
AD based on those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    We issued AD 2016-19-14, Amendment 39-18663 (81 FR 71602, October
18, 2016) (``AD 2016-19-14''), for certain Airbus SAS Model A318 and
A319 series airplanes; Model A320-211, -212, -214, -231, -232, and -233
airplanes; and Model A321-111, -112, -131, -211, -212, -213, -231, and
-232 airplanes. AD 2016-19-14 requires repetitive inspections for
cracking of the 10VU rack fitting lugs, and repair of any cracking. AD
2016-19-14 resulted from a report of cracks found during maintenance
inspections on certain 10VU rack fitting lugs. We issued AD 2016-19-14
to address reading difficulties of flight-critical information
displayed to the flightcrew during a critical phase of flight, such as
an approach or takeoff, which could result in loss of airplane control
at an altitude insufficient for recovery.

Actions Since AD 2016-19-14 Was Issued

    AD 2016-19-14 applies to the identified airplane models on which
Airbus Modification 35869 has not been embodied in production. Since we
issued AD 2016-19-14, we have determined that the unsafe condition may
also exist on airplanes in a post-Airbus Modification 35869
configuration.
    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Union, has issued EASA AD
2018-0131, dated June 19, 2018 (referred to after this as the Mandatory
Continuing Airworthiness Information, or ``the MCAI''), to correct an
unsafe condition for all Airbus SAS Model A318 and A319 series
airplanes; A320-211, -212, -214, -216, -231, -232, and -233 airplanes;
and A321-111, -112, -131, -211, -212, -213, -231, and -232 airplanes.
The MCAI states:

    During an unscheduled maintenance operation on an A330
aeroplane, the 10VU rack was removed for access and cracks were
discovered on 10VU rack side fittings on lugs 1, 3 and 4. As a
similar design is installed on A320 family aeroplanes, a sampling
review was done to determine the possible fleet impact. The result
showed that several aeroplanes had cracked or broken 10VU rack side
fittings.
    This condition, if not detected and corrected, could lead to a
high vibration level on the primary flight and navigation displays
during critical flight phases (take-off and landing), possibly
creating reading difficulties for the crew.
    Prompted by these findings, Airbus developed mod 35869 to
reinforce the affected rack fitting lugs. For in-service aeroplanes,
Airbus published SB [service bulletin] A320-92-1087 to provide
detailed inspection (DET) and repair instructions. Consequently,
EASA AD 2015-0170 [which corresponds to FAA AD 2016-19-14] was
issued to require, for all pre mod 35869 aeroplanes, repetitive DET
of the affected 10VU rack fitting lugs and, depending on findings,
accomplishment of a repair.
    Since that [EASA] AD was issued, analysis confirmed the need to
extend the inspection to post mod 35869 aeroplanes. Airbus issued SB
A320-92-1119 providing instructions for DET and repair of those
aeroplanes accordingly. Airbus developed mod 157335 to further
reinforce and adjust the affected rack fitting lugs. Analysis is
still ongoing to confirm mod 157335 as terminating action for the
requirements of this [EASA] AD, and further AD action may follow.
    For the reason described above, this [EASA] AD retains the
requirements of EASA AD 2015-0170, which is superseded, expanding
the Applicability to include post mod 35869 aeroplanes, and
requiring, for all aeroplanes, repetitive DET of the affected 10VU
rack fitting lugs and, depending on findings, accomplishment of a
repair [and reporting positive and negative findings to Airbus].

    You may examine the MCAI in the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-
0903.

Model A320-216 Airplanes

    The Airbus SAS Model A320-216 was type certificated on December 19,
2016. Before that date, any EASA ADs that affected Model A320-216
airplanes were included on the Required Airworthiness Actions List
(RAAL). One or more Model A320-216 airplanes have subsequently been
placed on the U.S. Register, and will now be included in FAA AD
actions. For Model A320-216 airplanes, the requirements that correspond
to AD 2014-20-04 were mandated by the MCAI via the RAAL. Although that
RAAL requirement is still in effect, for continuity and clarity we have
identified Model A320-216 airplanes in paragraph (c) of this AD; the
requirements of paragraphs (g) through (i) in this proposed AD would
therefore apply to those airplanes.

Related Service Information Under 1 CFR Part 51

    Airbus has issued Service Bulletins A320-92-1087, Revision 03,
dated July 31, 2017; and A320-92-1119, dated July 28, 2017. This
service information describes procedures for repetitive inspections for
cracking of the 10VU rack fitting lugs, and repair of any cracking.
These documents are distinct since they apply to airplanes in different
configurations. 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 the ADDRESSES section.

FAA's Determination

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI and service
information referenced above. We are proposing this AD because we
evaluated all the relevant information and determined the unsafe
condition described previously is likely to exist or develop

on other products of the same type design.

Proposed Requirements of This NPRM

    This proposed AD would retain all of the requirements of AD 2016-
19-14 and expand the applicability to include additional airplanes.
This proposed AD would require accomplishing the actions specified in
the service information described previously except as discussed under
``Differences Between this Proposed AD and the MCAI or Service
Information.'' This proposed AD also would require sending the
inspection results to Airbus SAS.

Differences Between This Proposed AD and the MCAI or Service
Information

    This proposed AD would not permit further flight if cracks are
detected in any 10VU rack fitting lug, but the MCAI permits flight for
a limited time if cracking is detected in a single 10VU rack fitting
lug. We have determined that, because of the safety implications and
consequences associated with that cracking, any cracked 10VU rack
fitting lug must be repaired before further flight. This difference has
been coordinated with the EASA.

Costs of Compliance

    We estimate that this proposed AD affects 461 airplanes of U.S.
registry. We estimate the following costs to comply with this proposed
AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per       Cost on U.S.
                          Labor cost                              Parts cost        product         operators
----------------------------------------------------------------------------------------------------------------
2 work-hours x $85 per hour = $170...........................              $0             $170          $78,370
----------------------------------------------------------------------------------------------------------------

    We estimate that it would take about 1 work-hour per product to
comply with the reporting requirement in this proposed AD. The average
labor rate is $85 per hour. Based on these figures, we estimate the
cost of reporting the inspection results on U.S. operators to be $85
per product.
    We estimate the following costs to do any necessary repairs that
would be required based on the results of the proposed inspection. We
have no way of determining the number of aircraft that might need these
repairs:

                 Estimated Costs of On-Condition Actions
------------------------------------------------------------------------
                                                             Cost per
              Labor cost                   Parts cost        product
------------------------------------------------------------------------
83 work-hours x $85 per hour = $7,055.          $9,140          $16,195
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Paperwork Reduction Act

    A federal agency may not conduct or sponsor, and a person is not
required to respond to, nor shall a person be subject to penalty for
failure to comply with a collection of information subject to the
requirements of the Paperwork Reduction Act unless that collection of
information displays a current valid OMB control number. The control
number for the collection of information required by this AD is 2120-
0056. The paperwork cost associated with this AD has been detailed in
the Costs of Compliance section of this document and includes time for
reviewing instructions, as well as completing and reviewing the
collection of information. Therefore, all reporting associated with
this AD is mandatory. Comments concerning the accuracy of this burden
and suggestions for reducing the burden should be directed to the FAA
at 800 Independence Ave. SW, Washington, DC 20591, ATTN: Information
Collection Clearance Officer, AES-200.

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.
    We are 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.
    This proposed AD is issued in accordance with authority delegated
by the Executive Director, Aircraft Certification Service, as
authorized by FAA Order 8000.51C. In accordance with that order,
issuance of ADs is normally a function of the Compliance and
Airworthiness Division, but during this transition period, the
Executive Director has delegated the authority to issue ADs applicable
to transport category airplanes and associated appliances to the
Director of the System Oversight Division.

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would 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 proposed
regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866,
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979),
    3. Will not affect intrastate aviation in Alaska, and
    4. 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 Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator,

the FAA proposes to amend 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 removing Airworthiness Directive (AD)
2016-19-14, Amendment 39-18663 (81 FR 71602, October 18, 2016), and
adding the following new AD:

Airbus SAS: Docket No. FAA-2018-0903; Product Identifier 2018-NM-
113-AD.

(a) Comments Due Date

    We must receive comments by December 20, 2018.

(b) Affected ADs

    This AD replaces AD 2016-19-14, Amendment 39-18663 (81 FR 71602,
October 18, 2016) (``AD 2016-19-14'').

(c) Applicability

    This AD applies to the Airbus SAS airplanes identified in
paragraphs (c)(1) through (c)(4) of this AD, certificated in any
category, all manufacturer serial numbers.
    (1) Model A318-111, -112, -121, and -122 airplanes.
    (2) Model A319-111, -112, -113, -114, -115, -131, -132, and -133
airplanes.
    (3) Model A320-211, -212, -214, -216, -231, -232, and -233
airplanes.
    (4) Model A321-111, -112, -131, -211, -212, -213, -231, and -232
airplanes.

(d) Subject

    Air Transport Association (ATA) of America Code 92, Electric and
Electronic Common Installation.

(e) Reason

    This AD was prompted by a report of cracks found during
maintenance inspections on certain 10VU rack fitting lugs. We are
issuing this AD to address reading difficulties of flight-critical
information displayed to the flightcrew during a critical phase of
flight, such as an approach or takeoff, which could result in loss
of airplane control at an altitude insufficient for recovery.

(f) Compliance

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

(g) Definitions

    For the purpose of this AD, Group 1 airplanes are in a pre-
Airbus Modification 35869 configuration, and Group 2 airplanes are
in a post-Airbus Modification 35869 configuration.

(h) Repetitive Inspections

    (1) For Group 1 airplanes: At the later of the times specified
in table 1 to paragraph (h)(1) of this AD, and thereafter at
intervals not to exceed 20,000 flight cycles or 40,000 flight hours,
whichever occurs first, do a detailed inspection for cracking of the
10VU rack fitting lugs, in accordance with the Accomplishment
Instructions of Airbus Service Bulletin A320-92-1087, Revision 03,
dated July 31, 2017.

  Table 1 to Paragraph (h)(1) of This AD--Initial Inspection Compliance
                       Time for Group 1 Airplanes
------------------------------------------------------------------------

------------------------------------------------------------------------
            Compliance time (whichever occurs later, A or B)
------------------------------------------------------------------------
A.................................  Prior to exceeding 30,000 total
                                     flight cycles or 60,000 total
                                     flight hours.
B.................................  Within 24 months after November 22,
                                     2016 (the effective date of AD
                                     2016[dash]19[dash]14).
------------------------------------------------------------------------

    (2) For Group 2 airplanes: At the later of the times specified
in paragraphs (h)(2)(i) and (h)(2)(ii) of this AD, and thereafter at
intervals not to exceed 20,000 flight cycles or 40,000 flight hours,
whichever occurs first, do a detailed inspection for cracking of the
10VU rack fitting lugs, in accordance with the Accomplishment
Instructions of Airbus Service Bulletin A320-92-1119, dated July 28,
2017.
    (i) Prior to exceeding 30,000 total flight cycles or 60,000
total flight hours, whichever occurs first.
    (ii) Within 30 days after the effective date of this AD.

(i) Repair

    If any crack is found during any inspection required by
paragraph (h)(1) or (h)(2) of this AD: Before further flight, do a
repair in accordance with the Accomplishment Instructions of Airbus
Service Bulletin A320-92-1087, Revision 03, dated July 31, 2017 (for
Group 1 airplanes); or Service Bulletin A320-92-1119, dated July 28,
2017 (for Group 2 airplanes); as applicable. Repair of a 10VU rack
fitting lug does not terminate the repetitive inspections required
by paragraphs (h)(1) and (h)(2) of this AD.

(j) Reporting

    At the applicable time specified in paragraph (j)(1) or (j)(2)
of this AD: Submit a report of findings (positive and negative) of
each inspection required by paragraph (h) of this AD to Airbus
Service Bulletin Reporting Online Application on Airbus World
(https://w3.airbus.com/), or submit the results to Airbus in
accordance with the instructions of Airbus Service Bulletin A320-92-
1087, Revision 03, dated July 31, 2017 (for Group 1 airplanes); or
Service Bulletin A320-92-1119, dated July 28, 2017 (for Group 2
airplanes); as applicable. Where Figure A-FAAAA, Sheet 02, of
Appendix 01, ``Inspection Report,'' of Airbus Service Bulletin A320-
92-1087, Revision 03, dated July 31, 2017; and Figure A-FAAAA, Sheet
02, of Appendix 01, ``Inspection Report,'' of Service Bulletin A320-
92-1119, dated July 28, 2017; specifies sending removed lugs to
Airbus for investigation, this AD does not include that requirement.
    (1) If the inspection was done on or after the effective date of
this AD: Submit the report within 90 days after the inspection.
    (2) If the inspection was done before the effective date of this
AD: Submit the report within 90 days after the effective date of
this AD.

(k) Credit for Previous Actions

    This paragraph provides credit for actions required by
paragraphs (h)(1) and (i) of this AD if those actions were performed
before the effective date of this AD using Airbus Service Bulletin
A320-92-1087, Revision 02, dated November 25, 2014.

(l) Paperwork Reduction Act Burden Statement

    A federal agency may not conduct or sponsor, and a person is not
required to respond to, nor shall a person be subject to a penalty
for failure to comply with a collection of information subject to
the requirements of the Paperwork Reduction Act unless that
collection of information displays a current valid OMB Control
Number. The OMB Control Number for this information collection is
2120-0056. Public reporting for this collection of information is
estimated to be approximately 1 hour per response, including the
time for reviewing instructions, completing and reviewing the
collection of information. All responses to this collection of
information are mandatory. Comments concerning the accuracy of this
burden and suggestions for reducing the burden should be directed to
the FAA at: 800 Independence Ave. SW, Washington, DC 20591, Attn:
Information Collection Clearance Officer, AES-200.

(m) Other FAA AD Provisions

    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Section, Transport Standards 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 International Section, send it to the attention of
the person identified in paragraph (n)(2) of this AD. Information
may be emailed to: [email protected]. 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.

    (2) Contacting the Manufacturer: As of the effective date of
this AD, for any requirement in this AD to obtain corrective actions
from a manufacturer, the action must be accomplished using a method
approved by the Manager, International Section, Transport Standards
Branch, FAA; or the European Aviation Safety Agency (EASA); or
Airbus SAS's EASA Design Organization Approval (DOA). If approved by
the DOA, the approval must include the DOA-authorized signature.
    (3) Required for Compliance (RC): If any service information
contains procedures or tests that are identified as RC, those
procedures and tests must be done to comply with this AD; any
procedures or tests that are not identified as RC are recommended.
Those procedures and tests that are not identified as RC may be
deviated from using accepted methods in accordance with the
operator's maintenance or inspection program without obtaining
approval of an AMOC, provided the procedures and tests identified as
RC can be done and the airplane can be put back in an airworthy
condition. Any substitutions or changes to procedures or tests
identified as RC require approval of an AMOC.

(n) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) EASA Airworthiness Directive 2018-0131, dated June 19, 2018,
for related information. This MCAI may be found in the AD docket on
the internet at http://www.regulations.gov by searching for and
locating Docket No. FAA-2018-0903.
    (2) For more information about this AD, contact Sanjay Ralhan,
Aerospace Engineer, International Section, Transport Standards
Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone
and fax<PHONE_NUMBER>.
    (3) For service information identified in this AD, contact
Airbus SAS, Airworthiness Office--EIAS, Rond-Point Emile Dewoitine
No: 2, 31700 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax
+33 5 61 93 44 51; email [email protected]; internet
http://www.airbus.com. You may view this service information at the
FAA, Transport Standards Branch, 2200 South 216th St., Des Moines,
WA. For information on the availability of this material at the FAA,
call<PHONE_NUMBER>.

    Issued in Des Moines, Washington, on October 22, 2018.
Michael Kaszycki,
Acting Director, System Oversight Division, Aircraft Certification
Service.
[FR Doc. 2018-23689 Filed 11-2-18; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 79, Number 60 (Friday, March 28, 2014)]
[Notices]
[Pages 17538-17539]
[FR Doc No: 2014-06958]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9908-90-OA]

Notification of a Public Teleconference of the Chartered Clean
Air Scientific Advisory Committee (CASAC) and the CASAC Oxides of
Nitrogen Primary NAAQS Review Panel

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency (EPA) Science Advisory
Board (SAB) Staff Office announces a public teleconference of the
Chartered Clean Air Scientific Advisory Committee (CASAC) and the CASAC
Oxides of Nitrogen Primary National Ambient Air Quality Standards
(NAAQS) Review Panel to discuss its draft reviews of EPA's Integrated
Review Plan for the Primary National Ambient Air Quality Standards for
Nitrogen Dioxide (External Review Draft) and Integrated Science
Assessment (ISA) for Oxides of Nitrogen--Health Criteria (External
Review Draft--November 2013).

DATES: The teleconference will be held on Wednesday, May 7, 2014 from
9:00 a.m. to 1:00 p.m. (Eastern Time).
    Location: The public teleconference will be held by telephone only.

FOR FURTHER INFORMATION CONTACT: Any member of the public wishing to
obtain information concerning the public

teleconference may contact Mr. Aaron Yeow, Designated Federal Officer
(DFO), via telephone at<PHONE_NUMBER> or at<EMAIL_ADDRESS>
General information about the CASAC, as well as any updates concerning
the meeting announced in this notice, may be found on the EPA Web site
at http://www.epa.gov/casac.

SUPPLEMENTARY INFORMATION: The CASAC was established pursuant to the
Clean Air Act (CAA) Amendments of 1977, codified at 42 U.S.C.
7409(d)(2), to review air quality criteria and NAAQS and recommend any
new NAAQS and revisions of existing criteria and NAAQS as may be
appropriate. The CASAC shall also provide advice, information, and
recommendations to the Administrator on the scientific and technical
aspects of issues related to the criteria for air quality standards,
research related to air quality, sources of air pollution, and of
adverse effects which may result from various strategies to attain and
maintain air quality standards. The CASAC is a Federal Advisory
Committee chartered under the Federal Advisory Committee Act (FACA), 5
U.S.C., App. 2. Section 109(d)(1) of the CAA requires that the Agency
periodically review and revise, as appropriate, the air quality
criteria and the NAAQS for the six ``criteria'' air pollutants,
including oxides of nitrogen. EPA is currently reviewing the primary
(health-based) NAAQS for nitrogen dioxide (NO2), as an
indicator for health effects caused by the presence of oxides of
nitrogen in the ambient air.
    For purposes of the review of the oxides of nitrogen air quality
criteria for health and the primary NAAQS for nitrogen dioxide, the
CASAC Oxides of Nitrogen Primary National Ambient Air Quality Standards
Review Panel was formed following a request for public nominations of
experts (77 FR 63827-63828) and met on March 12-13, 2014 (as noticed in
79 FR 8701-8703) to peer review EPA's Integrated Science Assessment for
Oxides of Nitrogen--Health Criteria (External Review Draft--November
2013) and Integrated Review Plan for the Primary National Ambient Air
Quality Standards for Nitrogen Dioxide (External Review Draft).
Information about these review activities may be found on the CASAC Web
site at http://www.epa.gov/casac. Pursuant to FACA and EPA policy,
notice is hereby given that the Chartered CASAC and the CASAC Oxides of
Nitrogen Primary NAAQS Review Panel will hold a public teleconference
to discuss its draft reviews of these two EPA documents. The CASAC
Oxides of Nitrogen Primary NAAQS Review Panel and the CASAC will comply
with the provisions of FACA and all appropriate SAB Staff Office
procedural policies.
    Technical Contacts: Any technical questions concerning the
Integrated Science Assessment for Oxides of Nitrogen--Health Criteria
(External Review Draft--November 2013) should be directed to Dr. Molini
Patel<EMAIL_ADDRESS>and technical questions concerning the
Integrated Review Plan for the Primary National Ambient Air Quality
Standards for Nitrogen Dioxide (External Review Draft) should be
directed to Ms. Beth Hassett-Sipple (hassett-sipple.beth@epa.gov).
    Availability of Meeting Materials: Prior to the meeting, the review
documents, agenda and other materials will be accessible through the
calendar link on the blue navigation bar at http://www.epa.gov/casac/.
    Procedures for Providing Public Input: Public comment for
consideration by EPA's federal advisory committees and panels has a
different purpose from public comment provided to EPA program offices.
Therefore, the process for submitting comments to a federal advisory
committee is different from the process used to submit comments to an
EPA program office.
    Federal advisory committees and panels, including scientific
advisory committees, provide independent advice to EPA. Members of the
public can submit comments for a federal advisory committee to consider
as it develops advice for EPA. Interested members of the public may
submit relevant written or oral information on the topic of this
advisory activity, and/or the group conducting the activity, for the
CASAC to consider during the advisory process. Input from the public to
the CASAC will have the most impact if it provides specific scientific
or technical information or analysis for CASAC panels to consider or if
it relates to the clarity or accuracy of the technical information.
Members of the public wishing to provide comment should contact the DFO
directly. Oral Statements: In general, individuals or groups requesting
an oral presentation on a public teleconference will be limited to
three minutes. Each person making an oral statement should consider
providing written comments as well as their oral statement so that the
points presented orally can be expanded upon in writing. Interested
parties should contact Mr. Aaron Yeow, DFO, in writing (preferably via
email) at the contact information noted above by April 30, 2014 to be
placed on the list of public speakers. Written Statements: Written
statements should be supplied to the DFO via email at the contact
information noted above by April 30, 2014 so that the information may
be made available to the Panel members for their consideration. Written
statements should be supplied in one of the following electronic
formats: Adobe Acrobat PDF, MS Word, MS PowerPoint, or Rich Text files
in IBM-PC/Windows 98/2000/XP format. It is the SAB Staff Office general
policy to post written comments on the Web page for the advisory
meeting or teleconference. Submitters are requested to provide an
unsigned version of each document because the SAB Staff Office does not
publish documents with signatures on its Web sites. Members of the
public should be aware that their personal contact information, if
included in any written comments, may be posted to the CASAC Web site.
Copyrighted material will not be posted without explicit permission of
the copyright holder.
    Accessibility: For information on access or services for
individuals with disabilities, please contact Mr. Aaron Yeow at (202)
564-2050 or<EMAIL_ADDRESS>To request accommodation of a
disability, please contact Mr. Yeow preferably at least ten days prior
to each meeting to give EPA as much time as possible to process your
request.

    Dated: March 20, 2014.
Thomas H. Brennan,
 Deputy Director, EPA Science Advisory Staff Office.
[FR Doc. 2014-06958 Filed 3-27-14; 8:45 am]
BILLING CODE 6560-50-P


			  UNITED STATES OF AMERICA

		        DEPARTMENT OF TRANSPORTATION

			  OFFICE OF THE SECRETARY

			          WASHINGTON, D.C.

Issued by the Department of Transportation on September 5, 2003

NOTICE OF ACTION TAKEN -- DOCKET OST 2003-16077

________________________________________________________________________
________________________________________________________

This serves as notice to the public of the action described below, taken
by the Department official indicated (no additional confirming order
will be issued in this matter).

Applicant:  VOLGA-DNEPR J.S. CARGO AIRLINE

Date Filed:  September 2, 2003, as supplemented September 4, 2003

Relief requested:  Exemption from 49 U.S.C. section 40109(g) to permit
the applicant to operate one, one-way cargo charter flight from
Philadelphia, Pennsylvania, to Moffet Field, Sunnyvale, California, on
or about September 15-16, 2003, using its AN-124-100 aircraft, to carry
one Lockheed Martin Commercial Space Systems AMC-SES communications
satellite, on behalf of Lockheed Martin.  The applicant stated that
Lockheed Martin needs prompt shipment of this cargo to Moffet Field to
complete aggressive development and launch schedules, that the cargo is
too large for transportation on U.S.-carrier aircraft; and that surface
transportation is not feasible because of the delicate nature and high
value of the cargo, and conditions unsuitable to maintaining system
integrity compliance.

Applicant representative:  Glenn P. Wicks,<PHONE_NUMBER>         DOT
analyst:  Allen F. Brown,<PHONE_NUMBER>

Responsive pleadings:  Volga-Dnepr served its application on those U.S.
carriers operating large all-cargo aircraft.  Each carrier indicated
that it did not have aircraft available to conduct the proposed
operations and that it had no comment or did not oppose grant of the
requested authority.

Statutory Standards:  Under 49 U.S.C. section 40109(g), we may authorize
a foreign air carrier to carry commercial traffic between U.S. points
(i.e., cabotage traffic) under limited circumstances.  Specifically, we
must find that the authority is required in the public interest; that
because of an emergency created by unusual circumstances not arising in
the normal course of business the traffic cannot be accommodated by U.S.
carriers holding certificates under 49 U.S.C. section 41102; that all
possible efforts have been made to place the traffic on U.S. carriers;
and that the transportation is necessary to avoid unreasonable hardship
to the traffic involved (an additional required finding, concerning
emergency transportation during labor disputes, was not relevant here).

        DISPOSITION

Action: Approved
                                             Action date:  September 5,
2003

Effective dates of authority granted:  September 5, 2003, through
September 18, 2003

Basis for approval:  We are granting Volga-Dnepr’s request to operate
its proposed one-way flight from Philadelphia to Moffet Field, through
September 18, 2003.  We found that its request met all the relevant
criteria of 49 U.S.C. section 40109(g) for the grant of an exemption of
this type and that the grant was required in the public interest.
Specifically, we were persuaded that the need to move the cargo promptly
in order to meet the urgent development and launch schedules, the fact
that the cargo could not be transported by surface transportation
because of its delicate nature and high value, the potential negative
impact of delivery delay; and the unique, outsized nature of the cargo,
constituted an emergency not arising in the normal course of business.
Moreover, based on the representations of the U.S. carriers, we
concluded that no U.S. carrier had aircraft available that could be used
to conduct the operations at issue here.  We also found that grant of
this authority would prevent unreasonable hardship to Lockheed Martin
Space Systems.  Finally, we found that the applicant was qualified to
perform its proposed operation.

Except to the extent exempted/waived, this authority is subject to our
standard exemption conditions and to the condition that the applicant
must comply with an FAA-approved flight routing for the authorized
operation.

Action taken by:      Michael W. Reynolds

                                  Acting Assistant Secretary for

                                     Aviation and International Affairs

An electronic version of this document is available on the World Wide
Web at:

http://dms.dot.gov//reports/reports_aviation.asp


[Federal Register Volume 85, Number 217 (Monday, November 9, 2020)]
[Notices]
[Page 71383]
[FR Doc No: 2020-24841]

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SECURITIES AND EXCHANGE COMMISSION

[SEC File No. 270-422, OMB Control No. 3235-0471]

Proposed Collection; Comment Request

Upon Written Request, Copies Available From: U.S. Securities and
Exchange Commission, Office of FOIA Services, 100 F Street NE,
Washington, DC 20549-2736

Extension:
    Rule 15c1-5

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (``PRA'') (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') is soliciting comments on the existing
collection of information provided for in Rule 15c1-5 (17 CFR 240.15c1-
5) under the Securities Exchange Act of 1934 (15 U.S.C. 78a et seq.).
The Commission plans to submit this existing collection of information
to the Office of Management and Budget (``OMB'') for extension and
approval.
    Rule 15c1-5 states that any broker-dealer controlled by,
controlling, or under common control with the issuer of a security that
the broker-dealer is trying to sell to or buy from a customer must give
the customer written notification disclosing the control relationship
at or before completion of the transaction. The Commission estimates
that 181 respondents provide notifications annually under Rule 15c1-5
and that each respondent would spend approximately 10 hours per year
complying with the requirements of the rule for a total burden of
approximately 1,810 hours per year. There is no retention period
requirement under Rule 15c1-5. This Rule does not involve the
collection of confidential information.
    Written comments are invited on: (a) Whether the proposed
collection of information is necessary for the proper performance of
the functions of the Commission, including whether the information
shall have practical utility; (b) the accuracy of the Commission's
estimates of the burden of the proposed collection of information; (c)
ways to enhance the quality, utility, and clarity of the information to
be collected; and (d) ways to minimize the burden of the collection of
information on respondents, including through the use of automated
collection techniques or other forms of information technology.
Consideration will be given to comments and suggestions submitted in
writing within 60 days of this publication.
    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.
    Please direct your written comments to: David Bottom, Director/
Chief Information Officer, Securities and Exchange Commission, c/o
Cynthia Roscoe, 100 F Street NE, Washington, DC 20549, or send an email
to<EMAIL_ADDRESS>
    Dated: November 4, 2020.
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2020-24841 Filed 11-6-20; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 88, Number 235 (Friday, December 8, 2023)]
[Notices]
[Pages 85625-85627]
[FR Doc No: 2023-26992]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2022-E-2194, FDA-2022-E-2195, and FDA-2022-E-2196]

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

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 Tivdak and is publishing
this notice of that determination as required by law. FDA has made the
determination because of the submission of applications to the Director
of the U.S. Patent and Trademark Office (USPTO), Department of
Commerce, for the extension of patents which claim that human
biological product.

DATES: Anyone with knowledge that any of the dates as published (see
SUPPLEMENTARY INFORMATION) are incorrect must submit either electronic
or written comments and ask for a redetermination by February 6, 2024.
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 June 5, 2024. 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. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of February 6, 2024. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received 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 Nos.
FDA-2022-E-2194, FDA-2022-E-2195, and FDA-2022-E-2196 for
``Determination of Regulatory Review Period for Purposes of Patent
Extension; TIVDAK.'' 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 biological 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 biological products, the
testing phase begins when the exemption to permit the clinical
investigations of the biological product becomes effective and runs
until the approval phase begins. The approval phase starts with the
initial submission of an application to market the human biological
product and continues until FDA grants permission to market the
biological 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 biological 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 biologic product Tivdak
(tisotumab vedotin). Tivdak is indicated for the treatment of adult
patients with recurrent or metastatic cervical cancer with disease
progression on or after chemotherapy. Subsequent to this approval, the
USPTO received patent term restoration applications for Tivdak (U.S.
Patent Nos. 9,150,658; 9,168,314; and 9,492,565) from Genmab A/S, and
the USPTO requested FDA's assistance in determining the patents'
eligibility for patent term restoration. In a letter dated September
21, 2022, FDA advised the USPTO that this human biological product had
undergone a regulatory review period and that the approval of Tivdak
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
Tivdak is 2,959 days. Of this time, 2,736 days occurred during the
testing phase of the regulatory review period, while 223 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 (21 U.S.C. 355(i)) became effective: August 16,
2013. The applicant claims August 17, 2013, as the date the
investigational new drug application (IND) became effective. However,
FDA records indicate that the IND effective date was August 16, 2013,
which was the first date after receipt of the IND that the
investigational studies were allowed to proceed.
    2. The date the application was initially submitted with respect to
the human biological product under section 351 of the Public Health
Service Act (42 U.S.C. 262): February 10, 2021. FDA has verified the
applicant's claim that the biologics license application (BLA) for
Tivdak (BLA B761208) was initially submitted on February 10, 2021.
    3. The date the application was approved: September 20, 2021. FDA
has verified the applicant's claim that BLA B761208 was approved on
September 20, 2021.
    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 applications for patent extension,
this applicant seeks 997 days, 1,077 days, or 1,190 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: December 5, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-26992 Filed 12-7-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: November 17, 2009 (Volume 74, Number 220)]
[Notices]
[Page 59158]
[DOCID:fr17no09-46]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER10-149-000]

Elk City Wind, LLC; Supplemental Notice that Initial Market-Based
Rate Filing Includes Request for Blanket Section 204 Authorization

November 10, 2009.
    This is a supplemental notice in the above-referenced proceeding of
Elk City Wind, LLC's application for market-based rate authority, with
an accompanying rate tariff, noting that such application includes a
request for blanket authorization, under 18 CFR part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC, 20426, in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214). Anyone filing a motion to intervene or protest must serve a
copy of that document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is November 30, 2009.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://
www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St., NE., Washington, DC, 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for 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 dockets(s). For assistance
with any FERC Online service, please e-mail<EMAIL_ADDRESS>
or call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

Kimberly D. Bose,
Secretary.
[FR Doc. E9-27563 Filed 11-16-09; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 5 (Monday, January 9, 2012)]
[Rules and Regulations]
[Pages 1025-1027]
[FR Doc No: 2012-109]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2011-0101]
RIN 1625-AA87

Security Zones; Cruise Ships, San Pedro Bay, CA

AGENCY: Coast Guard, DHS.

ACTION: Final rule.

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

SUMMARY: The Coast Guard is amending a security zone regulation for
cruise ships visiting San Pedro Bay, California by providing a common
description of all security zones to encompass only navigable waters
within a 100-yard radius around any cruise ship that is located within
the San Pedro Bay port area landward of the sea buoys bounding the Port
of Los Angeles or Port of Long Beach or at designated anchorages within
3 nautical miles of the Federal breakwater. This rule is necessary to
provide for the safety of the cruise ship, vessels, and users of the
waterway. Entry into these security zones will be prohibited unless
specifically authorized by the Captain of the Port (COTP) Los Angeles--
Long Beach, or his designated representative.

DATES: This rule is effective February 8, 2012.

ADDRESSES: The contents of the online docket for this rulemaking, USCG-
2011-0101, may be viewed by going to http://www.regulations.gov,
inserting USCG-2011-0101 in the ``Keyword box, and then clicking
``Search.'' This material is also available for inspection or copying
at the Docket Management facility (M-30), U.S. Department of
Transportation, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Ensign Stephen M. Sanders, Assistant Chief, Waterways
Management, Coast Guard Sector Los Angeles--Long Beach, Coast Guard;
telephone<PHONE_NUMBER>, email<EMAIL_ADDRESS>If you have
any questions on viewing the docket, call Renee V. Wright, Program
Manager, Docket Operations, telephone<PHONE_NUMBER>.

Regulatory Information

    On August 16, 2011, we published a noticed of proposed rulemaking
(NPRM) entitled Security Zones; Cruise Ships, San Pedro Bay, CA in the
Federal Register (76 FR 50710). We received no comments on the proposed
rule, either through the electronic docket office, or directly to Coast
Guard Sector Los Angeles--Long Beach. A public meeting was not
requested, and none were held.

Basis and Purpose

    Based on experience with actual security zone enforcement
operations, the COTP Los Angeles--Long Beach has concluded that a
security zone is needed encompassing all navigable waters, extending
from the surface to the sea floor, within a 100 yard radius around any
cruise ship that is within the San Pedro Bay port area inside the sea
buoys bounding the Port of Los Angeles or Port of Long Beach or at
designated anchorages within 3 nautical miles of the Federal
breakwater. This

will provide for the safety of the cruise ship, vessels, and users of
the waterway.

Background

    The Coast Guard is amending an existing security zone regulation.
The security zones created by this rule will encompass only navigable
waters within a 100-yard radius around any cruise ship that is located
within the San Pedro Bay port area landward of the sea buoys bounding
the Port of Los Angeles or Port of Long Beach or at designated
anchorages within 3 nautical miles of the Federal breakwater. These
security zones are necessary to provide for the safety of the cruise
ship, vessels, and users of the waterway. Entry into these security
zones is prohibited unless specifically authorized by the Captain of
the Port (COTP) Los Angeles--Long Beach, or his designated
representative.
    Paragraph (b)(1) and (b)(2) of the existing 33 CFR 165.1154
includes reference to the shore area and cruise ships anchored at
designated anchorages either inside or outside at designated anchorages
within 3 nautical miles of the Federal breakwaters. The COTP has
determined that security zones for moored cruise ships in Los Angeles--
Long Beach Harbors need not include any shore area, as passenger
terminals used for cruise ship operations are regulated under
regulations in 33 CFR part 105 issued under authority of the Maritime
Transportation Security Act of 2002 (Pub. L. 107-295). In addition to
clarifying the area covered by security zones created by Sec.
165.1154(b), this rule simplifies the regulation by not distinguishing
between anchored cruise ships, moored cruise ships, and cruise ships
underway. Also, Sec.  165.1154 paragraph (c) is amended to make it
clear that persons and vessels may not enter these security zones
without first obtaining permission of the Captain of the Port.

Discussion of Comments and Changes

    There were no comments submitted to the electronic docket or to the
Coast Guard Sector Los Angeles--Long Beach. No changes were made from
the proposed regulation.

Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking. Below we summarize our analyses
based on 14 of these statutes or executive orders.

Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, and does not
require an assessment of potential costs and benefits under section
6(a)(3) of that Order or under Executive Order 13563, Improving
Regulation and Regulatory Review. The Office of Management and Budget
has not reviewed it under that Order. It is not ``significant'' under
the regulatory policies and procedures of the Department of Homeland
Security (DHS). We expect the economic impact of this rule to be so
minimal that full Regulatory Evaluation is unnecessary. Most of the
entities likely to be affected are pleasure craft engaged in
recreational activities and sightseeing. In addition, due to National
Security interests, the implementation of this security zone regulation
is necessary for the protection of the United States and its people.
The size of the zones is the minimum necessary to provide adequate
protection for cruise ships.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this rule would have a significant economic impact
on a substantial number of small entities. The term ``small entities''
comprises small businesses, not-for-profit organizations that are
independently owned and operated and are not dominant in their fields,
and governmental jurisdictions with populations of less than 50,000.
    The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will
not have a significant economic impact on a substantial number of small
entities.
    This rule will affect the following entities, some of which may be
small entities: the owners or operators of vessels intending to transit
or anchor in Los Angeles--Long Beach ports within a 100-yard radius of
cruise ships covered by this rule.
    This security zone regulation will not have a significant economic
impact on a substantial number of small entities because vessel traffic
can pass safely around the zones.

Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we offer to assist small
entities in understanding the rule so that they can better evaluate its
effects on them and participate in the rulemaking process.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-(888) 734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

Collection of Information

    This rule calls for no new collection of information under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on State or local
governments and would either preempt State law or impose a substantial
direct cost of compliance on them. We have analyzed this rule under
that Order and have determined that it does not have implications for
federalism.

Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such expenditure, we do discuss the effects of this rule elsewhere in
this preamble.

Taking of Private Property

    This rule will not cause a taking of private property or otherwise
have taking implications under Executive Order 12630, Governmental
Actions and Interference with Constitutionally Protected Property
Rights.

Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

Protection of Children

    We have analyzed this rule under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and does not create an
environmental risk to

health or risk to safety that might disproportionately affect children.

Indian Tribal Governments

    This rule does not have tribal implications under Executive Order
13175, Consultation and Coordination with Indian Tribal Governments,
because it does not have a substantial direct effect on one or more
Indian tribes, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes.

Energy Effects

    We have analyzed this rule under Executive Order 13211, Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use. We have determined that it is not a ``significant
energy action'' under that order because it is not a ``significant
regulatory action'' under Executive Order 12866 and is not likely to
have a significant adverse effect on the supply, distribution, or use
of energy. The Administrator of the Office of Information and
Regulatory Affairs has not designated it as a significant energy
action. Therefore, it does not require a Statement of Energy Effects
under Executive Order 13211.

Technical Standards

    The National Technology Transfer and Advancement Act (NTTAA) (15
U.S.C. 272 note) directs agencies to use voluntary consensus standards
in their regulatory activities unless the agency provides Congress,
through the Office of Management and Budget, with an explanation of why
using these standards would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g. specifications of materials, performance, design, or
operation; test methods; sampling procedures; and related management
systems practices) that are developed or adopted by voluntary consensus
standards bodies.
    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have made a
determination that this action is one of a category of actions that do
not individually or cumulatively have a significant effect on the human
environment. This rule is categorically excluded, under figure 2-1,
paragraph (34) (g), of the Instruction. This rule involves amending a
security zone regulation by removing the reference to shore area in
security zones for moored cruise ships. An environmental analysis
checklist and a categorical exclusion determination are available in
the docket were indicated under ADDRESSES.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority:  33 U.S.C. 1231; 46 U.S.C. Chapter 701, 3306, 3703;
50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Pub.
L. 107-295, 116 Stat. 2064; Department of Homeland Security
Delegation No. 0170.1.

0
2. In Sec.  165.1154, revise paragraphs (b) and (c) to read as follows:

Sec.  165.1154  Security Zones; Moored Cruise Ships, San Pedro Bay,
California.

* * * * *
    (b) Location. The following areas are security zones: All navigable
waters, extending from the surface to the sea floor, within a 100-yard
radius around any cruise ship that is located within the San Pedro Bay
area landward of the sea buoys bounding the port of Los Angeles or Port
of Long Beach or designated anchorages within 3 nautical miles seaward
of the Federal Breakwaters.
    (c) Regulations. Under regulations in 33 CFR part 165, subpart D, a
person or vessel may not entry into or remain in the security zones
created by this section unless authorized by the Coast Guard Captain of
the Port, Los Angeles--Long Beach (COTP) or a COTP designated
representative.
    (1) Persons desiring to transit these security zones may contact
the COTP at telephone number<PHONE_NUMBER> or on VHF-FM channel 16
(156.8 MHz) to seek permission to transit the area. If permission is
granted, all persons and vessels must comply with the instructions of
the Captain of the Port or his or her designated representative.
    (2) When a cruise ship approaches within 100 yards of a vessel that
is moored, or anchored, the stationary vessel must stay moored or
anchored while it remains within the cruise ship's security zone unless
it is either ordered by, or given permission from, the COTP Los
Angeles-Long Beach to do otherwise.
* * * * *

    Dated: December 23, 2011.
R.R. Laferriere,
Captain, U.S. Coast Guard, Captain of the Port Los Angeles--Long Beach.
[FR Doc. 2012-109 Filed 1-6-12; 8:45 am]
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[Federal Register Volume 88, Number 142 (Wednesday, July 26, 2023)]
[Notices]
[Page 48283]
[FR Doc No: 2023-15845]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2022-0209]

Women of Trucking Advisory Board (WOTAB); Notice of Public
Meeting

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), Department
of Transportation (DOT).

ACTION: Notice of public meeting.

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SUMMARY: This notice announces a meeting of the WOTAB.

DATES: The meeting will be held on Monday, August 14, 2023, from 10
a.m. to 4:30 p.m. ET. Requests for accommodations for a disability must
be received by Friday, August 4. Requests to submit written materials
for consideration during the meeting must be received no later than
Friday, August 4.

ADDRESSES: The meeting will be held virtually for its entirety. Please
register in advance of the meeting at www.fmcsa.dot.gov/wotab. Copies
of WOTAB task statements and an agenda for the entire meeting will be
made available at www.fmcsa.dot.gov/wotab at least 1 week in advance of
the meeting. Once approved, copies of the meeting minutes will be
available at the website following the meeting. You may visit the WOTAB
website at www.fmcsa.dot.gov/wotab for further information on the
committee and its activities.

FOR FURTHER INFORMATION CONTACT: Ms. Shannon L. Watson, Designated
Federal Officer, WOTAB, FMCSA, 1200 New Jersey Avenue SE, Washington,
DC 20590,<PHONE_NUMBER>, [email protected]. Any committee-related request
should be sent to the person listed in this section.

SUPPLEMENTARY INFORMATION:

I. Background

    WOTAB was created under the Federal Advisory Committee Act (FACA)
in accordance with section 23007(d)(1) of the Bipartisan Infrastructure
Law (BIL) (Pub. L. 117-58), which requires the Federal Motor Carrier
Safety Administration (FMCSA) to establish WOTAB. WOTAB will review and
report on policies that provide education, training, mentorship, and
outreach to women in the trucking industry and identify barriers and
industry trends that directly or indirectly discourage women from
pursuing and retaining careers in trucking.
    WOTAB operates in accordance with FACA under the terms of the WOTAB
charter, filed February 11, 2022.

II. Agenda

    WOTAB will begin consideration of Task 23-3, Opportunities to
Enhance Trucking Training, Mentorship, Education, and Advancement and
Outreach Programs That Would Increase the Number of Women in the CMV
Industry. For this and all topics considered by the committee, FMCSA
will include presentations by Agency experts and those in the field
under discussion.

III. Public Participation

    The meeting will be open to the public via virtual platform.
Advance registration via the website is required.
    DOT is committed to providing equal access to this meeting for all
participants. If you need alternative formats or services due to a
disability, such as sign language interpretation or other ancillary
aids, please contact the person listed in the FOR FURTHER INFORMATION
CONTACT section by Friday, August 4.
    Oral comments from the public will be heard during designated
comment periods at the discretion of the WOTAB chair and Designated
Federal Officer. To accommodate as many speakers as possible, the time
for each commenter may be limited. Speakers are requested to submit a
written copy of their remarks for inclusion in the meeting records and
for circulation to WOTAB members. All prepared remarks submitted on
time will be accepted and considered as part of the record. Any member
of the public may present a written statement to the committee at any
time.

Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2023-15845 Filed 7-25-23; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 77, Number 49 (Tuesday, March 13, 2012)]
[Rules and Regulations]
[Page 14697]
[FR Doc No: 2012-5880]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R03-OAR-2011-0714; FRL-9645-6]

Approval and Promulgation of Air Quality Implementation Plans;
Delaware, New Jersey, and Pennsylvania; Determinations of Attainment of
the 1997 Annual Fine Particulate Standard for the Philadelphia-
Wilmington Nonattainment Area; Withdrawal of Direct Final Rule

AGENCY: Environmental Protection Agency (EPA).

ACTION: Withdrawal of direct final rule.

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SUMMARY: Due to an adverse comment, EPA is withdrawing the direct final
rule, published on January 23, 2012 (77 FR 3147), that made two
determinations regarding the Philadelphia-Wilmington fine particulate
(PM2.5) nonattainment area (the Philadelphia Area), which is
comprised of the New Castle County in Delaware; Burlington, Camden, and
Gloucester Counties in New Jersey; and Bucks, Chester, Delaware,
Montgomery, and Philadelphia Counties in Pennsylvania. First, EPA made
a determination that the Philadelphia Area attained the 1997 annual
PM2.5 national ambient air quality standard (NAAQS) by its
attainment date of April 5, 2010. Second, EPA made a clean data
determination, finding that the Philadelphia Area has attained the 1997
PM2.5 NAAQS, based on quality assured and certified ambient
air monitoring data for the 2007-2009 and 2008-2010 monitoring periods.
In the direct final rule, EPA stated that if we received adverse
comment by February 22, 2012, the rule would be withdrawn and not take
effect. EPA subsequently received adverse comments. EPA will address
the comments received in a subsequent final action based upon the
proposed action also published on January 23, 2012 (77 FR 3223). EPA
will not institute a second comment period on this action.

DATES: The direct final rule published on January 23, 2012 (77 FR 3147)
is withdrawn as of March 13, 2012.

ADDRESSES: EPA has established docket number EPA-R03-OAR-2011-0714 for
this action. The index to this action is available electronically at
http://www.regulations.gov and in hard copy at Air Protection Division,
U.S. Environmental Protection Agency, Region III, 1650 Arch Street,
Philadelphia, Pennsylvania 19103.

FOR FURTHER INFORMATION CONTACT: If you have questions concerning EPA's
action related to Delaware or Pennsylvania, please contact Maria A.
Pino,<PHONE_NUMBER>, or by email at<EMAIL_ADDRESS>If you have
questions concerning EPA's action related to New Jersey, please contact
Henry Feingersh,<PHONE_NUMBER>, or by email at
<EMAIL_ADDRESS>
List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Particulate matter, Reporting
and recordkeeping requirements.

    Dated: February 6, 2012.
W.C. Early,
Acting Regional Administrator, Region III.

    Accordingly, the addition of 40 CFR 52.425, 52.427, 52.1576,
52.1602(d), 52.2056(f), and 52.2059(e), published on January 23, 2012
(77 FR 3147), is withdrawn as of March 13, 2012.

    Dated: February 22, 2012.
Judith A. Enck,
Regional Administrator, Region II.
[FR Doc. 2012-5880 Filed 3-12-12; 8:45 am]
BILLING CODE 6560-50-P