[Federal Register Volume 86, Number 53 (Monday, March 22, 2021)]
[Proposed Rules]
[Pages 15151-15154]
[FR Doc No: 2021-05395]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2021-0184; Project Identifier MCAI-2020-01599-T]
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: The FAA proposes to adopt a new airworthiness directive (AD)
for all Airbus SAS Model A330-200, A330-200 Freighter, A330-300, A340-
200, and A340-300 series airplanes. This proposed AD was prompted by a
report that the auxiliary power unit (APU) aft fuel pump printed
circuit board (PCB) varnish had deteriorated; the varnish is one of the
layers of protection against development of an ignition source. This
proposed AD would require replacing each affected APU aft fuel pump, as
specified in a European Union Aviation Safety Agency (EASA) AD, which
is proposed for incorporation by reference. The FAA is proposing this
AD to address the unsafe condition on these products.

DATES: The FAA must receive comments on this proposed AD by May 6,
2021.

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 https://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 material that will be incorporated by reference (IBR) in this
AD, contact EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany;
telephone +49 221 8999 000; email<EMAIL_ADDRESS>internet
www.easa.europa.eu. You may find this IBR material on the EASA website
at https://ad.easa.europa.eu. You may view this IBR material at the
FAA, Airworthiness Products Section, Operational Safety Branch, 2200
South 216th St., Des Moines, WA. For information on the availability of
this

material at the FAA, call<PHONE_NUMBER>. It is also available in the AD
docket on the internet at https://www.regulations.gov by searching for
and locating Docket No. FAA-2021-0184.

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-2021-
0184; 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, any comments received, and other information. The street
address for Docket Operations is listed above.

FOR FURTHER INFORMATION CONTACT: Vladimir Ulyanov, Aerospace Engineer,
Large Aircraft Section, International Validation Branch, FAA, 2200
South 216th St., Des Moines, WA 98198; telephone and fax<PHONE_NUMBER>;
email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under ADDRESSES. Include ``Docket No. FAA-2021-0184; Project Identifier
MCAI-2020-01599-T'' at the beginning of your comments. The most helpful
comments reference a specific portion of the proposal, explain the
reason for any recommended change, and include supporting data. The FAA
will consider all comments received by the closing date and may amend
the proposal because of those comments.
    Except for Confidential Business Information (CBI) as described in
the following paragraph, and other information as described in 14 CFR
11.35, the FAA will post all comments received, without change, to
https://www.regulations.gov, including any personal information you
provide. The agency will also post a report summarizing each
substantive verbal contact received about this proposed AD.

Confidential Business Information

    CBI is commercial or financial information that is both customarily
and actually treated as private by its owner. Under the Freedom of
Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public
disclosure. If your comments responsive to this NPRM contain commercial
or financial information that is customarily treated as private, that
you actually treat as private, and that is relevant or responsive to
this NPRM, it is important that you clearly designate the submitted
comments as CBI. Please mark each page of your submission containing
CBI as ``PROPIN.'' The FAA will treat such marked submissions as
confidential under the FOIA, and they will not be placed in the public
docket of this NPRM. Submissions containing CBI should be sent to
Vladimir Ulyanov, Aerospace Engineer, Large Aircraft Section,
International Validation Branch, FAA, 2200 South 216th St., Des Moines,
WA 98198; telephone and fax<PHONE_NUMBER>; email
<EMAIL_ADDRESS>Any commentary that the FAA receives which is
not specifically designated as CBI will be placed in the public docket
for this rulemaking.

Discussion

    The EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD 2020-0265, dated December 2, 2020
(EASA AD 2020-0265) (also referred to as the Mandatory Continuing
Airworthiness Information, or the MCAI), to correct an unsafe condition
for all Airbus SAS Model A330-201, A330-202, A330-203, A330-223, A330-
243, A330-223F, A330-243F, A330-301, A330-302, A330-303, A330-321,
A330-322, A330-323, A330-341, A330-342, A330-343, A340-211, A340-212,
A340-213, A340-311, A340-312, and A340-313 airplanes.
    This proposed AD was prompted by a report that the APU aft fuel
pump PCB varnish had deteriorated. The varnish is one of the layers of
protection against development of an ignition source. The root cause
for the varnish deterioration is unknown, but suspected to be linked to
aging. The FAA is proposing this AD to address PCB varnish
deterioration. This condition, if not addressed, could, in case of a
spark or flame in the area of the pump PCB, result in a fire or
explosion and consequent loss of the airplane. See the MCAI for
additional background information.

Related Service Information Under 1 CFR Part 51

    EASA AD 2020-0265 describes procedures for replacing each affected
APU aft fuel pump. This material 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 and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to the FAA's bilateral agreement with the State of Design Authority,
the FAA has been notified of the unsafe condition described in the MCAI
referenced above. The FAA is proposing this AD because the FAA
evaluated all the relevant information and determined the unsafe
condition described previously is likely to exist or develop in other
products of the same type design.

Proposed AD Requirements

    This proposed AD would require accomplishing the actions specified
in EASA AD 2020-0265 described previously, as incorporated by
reference, except for any differences identified as exceptions in the
regulatory text of this AD.

Explanation of Required Compliance Information

    In the FAA's ongoing efforts to improve the efficiency of the AD
process, the FAA initially worked with Airbus and EASA to develop a
process to use certain EASA ADs as the primary source of information
for compliance with requirements for corresponding FAA ADs. The FAA has
since coordinated with other manufacturers and civil aviation
authorities (CAAs) to use this process. As a result, EASA AD 2020-0265
will be incorporated by reference in the FAA final rule. This proposed
AD would, therefore, require compliance with EASA AD 2020-0265 in its
entirety, through that incorporation, except for any differences
identified as exceptions in the regulatory text of this proposed AD.
Using common terms that are the same as the heading of a particular
section in the EASA AD does not mean that operators need comply only
with that section. For example, where the AD requirement refers to
``all required actions and compliance times,'' compliance with this AD
requirement is not limited to the section titled ``Required Action(s)
and Compliance Time(s)'' in the EASA AD. Service information specified
in EASA AD 2020-0265 that is required for compliance with EASA AD 2020-
0265 will be available on the internet at https://www.regulations.gov
by searching for and locating Docket No. FAA-2021-0184 after the FAA
final rule is published.

Costs of Compliance

    The FAA estimates that this proposed AD affects 112 airplanes of
U.S. registry. The FAA estimates the following costs to comply with
this proposed AD:

                                      Estimated Costs for Required Actions
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per       Cost on U.S.
                          Labor cost                              Parts cost        product         operators
----------------------------------------------------------------------------------------------------------------
4 work-hours x $85 per hour = $340...........................          $7,000           $7,340         $822,080
----------------------------------------------------------------------------------------------------------------

    According to the manufacturer, some or all of the costs of this
proposed AD may be covered under warranty, thereby reducing the cost
impact on affected operators. The FAA does not control warranty
coverage for affected operators. As a result, the FAA has included all
known costs in the cost estimate.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    The FAA is issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: General requirements.
Under that section, Congress charges the FAA with promoting safe flight
of civil aircraft in air commerce by prescribing regulations for
practices, methods, and procedures the Administrator finds necessary
for safety in air commerce. This regulation is within the scope of that
authority because it addresses an unsafe condition that is likely to
exist or develop on products identified in this rulemaking action.

Regulatory Findings

    The FAA 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) Would not affect intrastate aviation in Alaska, and
    (3) Would 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 adding the following new airworthiness
directive:

Airbus SAS: Docket No. FAA-2021-0184; Project Identifier MCAI-2020-
01599-T.

(a) Comments Due Date

    The FAA must receive comments on this airworthiness directive
(AD) action by May 6, 2021.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to all Airbus SAS airplanes, certificated in any
category, specified in paragraphs (c)(1) through (5) of this AD.
    (1) Model A330-201, -202, -203, -223, and -243 airplanes.
    (2) Model A330-223F and -243F airplanes.
    (3) Model A330-301, -302, -303, -321, -322, -323, -341, -342,
and -343 airplanes.
    (4) Model A340-211, -212, and -213 airplanes.
    (5) Model A340-311, -312, and -313 airplanes.

(d) Subject

    Air Transport Association (ATA) of America Code 28, Fuel system.

(e) Reason

    This AD was prompted by a report that the auxiliary power unit
(APU) aft fuel pump printed circuit board (PCB) varnish had
deteriorated; the varnish is one of the layers of protection against
development of an ignition source. The FAA is issuing this AD to
address PCB varnish deterioration. This condition, if not addressed,
could, in case of a spark or flame in the area of the pump PCB,
result in a fire or explosion and consequent loss of the airplane.

(f) Compliance

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

(g) Requirements

    Except as specified in paragraph (h) of this AD: Comply with all
required actions and compliance times specified in, and in
accordance with, European Union Aviation Safety Agency (EASA) AD
2020-0265, dated December 2, 2020 (EASA AD 2020-0265).

(h) Exceptions to EASA AD 2020-0265

    (1) Where EASA AD 2020-0265 refers to its effective date, this
AD requires using the effective date of this AD.
    (2) The ``Remarks'' section of EASA AD 2020-0265 does not apply
to this AD.

(i) No Reporting Requirement

    Although the service information referenced in EASA AD 2020-0265
specifies to submit certain information to the manufacturer, this AD
does not include that requirement.

(j) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
Large Aircraft Section, International Validation 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 responsible Flight
Standards Office, as appropriate. If sending information directly to
the Large Aircraft Section, International Validation Branch, send it
to the attention of the person identified in paragraph (k)(2) of
this AD. Information may be emailed to<EMAIL_ADDRESS>
Before using any approved AMOC, notify your appropriate principal
inspector, or lacking a principal inspector, the manager of the
responsible Flight Standards Office.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain instructions from a manufacturer, the instructions must be
accomplished using a method approved by the Manager, Large Aircraft
Section, International Validation Branch, FAA; or 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): Except as required by
paragraph (j)(2) of this AD, 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.

(k) Related Information

    (1) For information about EASA AD 2020-0265, contact the EASA,
Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone +49 221
8999 000; email<EMAIL_ADDRESS>Internet www.easa.europa.eu. You
may find this EASA AD on the EASA website at https://ad.easa.europa.eu. You may view this material at the FAA,
Airworthiness Products Section, Operational Safety Branch, 2200
South 216th St., Des Moines, WA. For information on the availability
of this material at the FAA, call<PHONE_NUMBER>. This material may be
found in the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-
2021-0184.
    (2) For more information about this AD, contact Vladimir
Ulyanov, Aerospace Engineer, Large Aircraft Section, International
Validation Branch, FAA, 2200 South 216th St., Des Moines, WA 98198;
telephone and fax<PHONE_NUMBER>; email<EMAIL_ADDRESS>
    Issued on March 10, 2021.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2021-05395 Filed 3-19-21; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 87, Number 129 (Thursday, July 7, 2022)]
[Rules and Regulations]
[Pages 40435-40438]
[FR Doc No: 2022-14335]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2022-0450; Project Identifier MCAI-2021-00854-A;
Amendment 39-22092; AD 2022-13-06]
RIN 2120-AA64

Airworthiness Directives; Diamond Aircraft Industries Inc.
Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: The FAA is adopting a new airworthiness directive (AD) for all
Diamond Aircraft Industries Inc. Model DA 40, DA 40 F, and DA 40 NG
airplanes. This AD was prompted by mandatory continuing airworthiness

information (MCAI) originated by an aviation authority of another
country to identify and correct an unsafe condition on an aviation
product. The MCAI describes the unsafe condition as baggage nets
installed with defective buckles, which may result in failure of the
baggage net to restrain the baggage or cargo, which could lead to
injury to the occupants in the case of an emergency landing. This AD
requires identifying and replacing the affected part. The FAA is
issuing this AD to address the unsafe condition on these products.

DATES: This AD is effective August 11, 2022.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in this AD as of August 11,
2022.

ADDRESSES: For service information identified in this final rule,
contact Diamond Aircraft Industries Inc., Att: Thit Tun, 1560 Crumlin
Road, London, N5V 1S2, Canada; phone:<PHONE_NUMBER>; email:
[email protected]. You may view this referenced service
information at the FAA, Airworthiness Products Section, Operational
Safety Branch, 901 Locust, Kansas City, MO 64106. For information on
the availability of this material at the FAA, call<PHONE_NUMBER>.
Service information that is incorporated by reference is also available
at https://www.regulations.gov by searching for and locating Docket No.
FAA-2022-0450.

Examining the AD Docket

    You may examine the AD docket at https://www.regulations.gov by
searching for and locating Docket No. FAA-2022-0450; or in person at
Docket Operations between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The AD docket contains this final rule, the
MCAI, any comments received, and other information. The address for
Docket Operations is U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Chirayu Gupta, Aviation Safety
Engineer, New York ACO Branch, FAA, 1600 Stewart Avenue, Suite 410,
Westbury, NY 11590; phone:<PHONE_NUMBER>; email:
[email protected].

SUPPLEMENTARY INFORMATION:

Background

    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 by adding an AD that would apply to all Diamond Aircraft
Industries Inc. Model DA 40, DA 40 F, and DA 40 NG airplanes. The NPRM
published in the Federal Register on April 8, 2022 (87 FR 20781). The
NPRM was prompted by MCAI originated by Transport Canada, which is the
aviation authority for Canada. Transport Canada issued AD CF-2021-24,
dated July 21, 2021 (referred to after this as ``the MCAI''), to
address an unsafe condition on all Diamond Aircraft Industries Inc.
Model DA 40, DA 40 D, DA 40 F, DA 40 NG, and DA 62 airplanes. The MCAI
states:

    Diamond Aircraft Industries Inc. (DAI) has received reports of
defective buckles installed as part of the baggage nets on DA 40 NG
and DA 62 aeroplanes. An investigation revealed a quality escape in
the manufacturing of the Quick Fix Baggage Net Assembly, part number
(P/N) D44-2550-90-00 and P/N D67-2550-90-00_02, by the supplier. P/N
D44-2550-90-00 baggage nets can also be installed on DA 40, DA 40 D
and DA 40 F aeroplanes. The baggage nets installed with defective
buckles may not maintain sufficient holding force to restrain the
baggage or cargo that is carried in the same compartment as
passengers, and consequently, may not provide adequate means to
protect the passengers from injury.
    This condition, if not corrected, could result in the failure of
the baggage net to restrain the baggage or cargo, which could lead
to injury to the occupants in the case of an emergency landing.
    DAI undertook a voluntary campaign to replace all defective
Quick Fix Baggage Net Assemblies. However, DAI was unable to
complete the campaign in its entirety, and therefore, a number of
aeroplanes with defective baggage nets that have not yet been
replaced, remain in operation.
    As a result, DAI issued Mandatory Service Bulletin (MSB) 40-093,
MSB D4-110, MSB F4-039, MSB 40NG-065 and MSB 62-028, providing
accomplishment instructions to replace the defective Quick Fix
Baggage Net Assemblies.
    This [Transport Canada] AD mandates the removal and replacement
of the affected baggage nets. This [Transport Canada] AD also
renders any affected baggage nets not eligible for installation as a
replacement part on DA 40, DA 40 D, DA 40 F, DA 40 NG and DA 62
aeroplanes.

    You may examine the MCAI in the AD docket at https://www.regulations.gov by searching for and locating Docket No. FAA-2022-
0450.
    In the NPRM, the FAA proposed to require identifying and replacing
affected baggage nets. The FAA is issuing this AD to prevent failure of
the baggage net to restrain the baggage or cargo. This unsafe
condition, if not corrected, could result in injury to occupants in the
case of an emergency landing.

Discussion of Final Airworthiness Directive

Comments

    The FAA received one comment on the NPRM from an individual. The
commenter supported the NPRM without change.

Conclusion

    These products have been approved by the aviation authority of
another country and are approved for operation in the United States.
Pursuant to the FAA's bilateral agreement with this State of Design
Authority, it has notified the FAA of the unsafe condition described in
the MCAI referenced above. The FAA reviewed the relevant data,
considered the comment received, and determined that air safety
requires adopting this AD as proposed. Accordingly, the FAA is issuing
this AD to address the unsafe condition on these products. This AD is
adopted as proposed in the NPRM.

Related Service Information Under 1 CFR Part 51

    The FAA reviewed the following service information issued by
Diamond Aircraft Industries Inc., which specify procedures for
identifying, removing, and replacing the affected baggage nets.
     Mandatory Service Bulletin No. MSB 40-093, Rev. 0, dated
July 6, 2021.
     Mandatory Service Bulletin No. MSB F4-039, Rev. 0, dated
July 6, 2021.
     Mandatory Service Bulletin No. MSB 40NG-065, Rev. 1, dated
July 6, 2021.
    These documents are distinct since they apply to different airplane
models.
    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.

Differences Between This AD and the MCAI or Service Information

    The MCAI applies to Diamond Aircraft Industries Inc. Model DA 40,
DA 40 D, DA 40 F, DA 40 NG, and DA 62 airplanes. This AD does not apply
to Model DA 62 airplanes. The FAA plans to address Model DA 62
airplanes in future rulemaking.
    In addition, the MCAI applies to the Model DA 40 D airplanes and
this AD does not because it does not have an FAA type certificate.

Costs of Compliance

    The FAA estimates that this AD affects 800 airplanes of U.S.
registry.
    The FAA estimates the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
                Action                         Labor cost           Parts cost       airplane        operators
----------------------------------------------------------------------------------------------------------------
Replace Model DA 40, DA 40 F, and DA    0.25 work-hour x $85 per            $382         $403.25        $322,600
 40 NG baggage net.                      hour = $21.25.
----------------------------------------------------------------------------------------------------------------

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    The FAA is issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: General requirements.
Under that section, Congress charges the FAA with promoting safe flight
of civil aircraft in air commerce by prescribing regulations for
practices, methods, and procedures the Administrator finds necessary
for safety in air commerce. This regulation is within the scope of that
authority because it addresses an unsafe condition that is likely to
exist or develop on products identified in this rulemaking action.

Regulatory Findings

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

List of Subjects in 14 CFR Part 39

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

The Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13   [Amended]

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

2022-13-06 Diamond Aircraft Industries Inc.: Amendment 39-22092;
Docket No. FAA-2022-0450; Project Identifier MCAI-2021-00854-A.

(a) Effective Date

    This airworthiness directive (AD) is effective August 11, 2022.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Diamond Aircraft Industries Inc. Model DA 40,
DA 40 F, and DA 40 NG airplanes (including Model DA 40 D airplanes
that have been converted to Model DA 40 NG airplanes), all serial
numbers, certificated in any category.

(d) Subject

    Joint Aircraft System Component (JASC) Code 2550, Cargo
Compartments.

(e) Unsafe Condition

    This AD was prompted by mandatory continuing airworthiness
information (MCAI) originated by an aviation authority of another
country to identify and correct an unsafe condition on an aviation
product. The MCAI describes the unsafe condition as baggage nets
installed with defective buckles. The FAA is issuing this AD to
prevent failure of the baggage net to restrain the baggage or cargo.
This unsafe condition, if not corrected, could result in injury to
occupants in the case of an emergency landing.

(f) Compliance

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

(g) Definitions

    The following are ``affected baggage nets'' for purposes of this
AD:
    (1) Quick fix baggage net assembly part number (P/N) D44-2550-
90-00 with a date of manufacture of December 2015, November 2016, or
March 2017; and
    (2) Quick fix baggage net assembly P/N D67-2550-90-00_02 with a
date of manufacture of June 2016.

(h) Required Actions

    (1) Within 12 months after the effective date of this AD or
within 50 hours time-in-service (TIS) after the effective date of
this AD, whichever occurs first, inspect each baggage net to
determine whether an affected baggage net is installed on your
airplane.
    Note to paragraph (h)(1): The date of manufacture is located on
the label with the abbreviation ``DMF.''
    (i) If an affected baggage net is installed, before further
flight, remove the baggage net from service.
    (ii) Before the next flight carrying baggage or cargo in the
baggage compartment, install a baggage net that is not an affected
baggage net in accordance with Figure 1 of the Accomplishment
Instructions in the applicable service information in paragraph (i)
of this AD.
    (2) As of the effective date of this AD, do not install an
affected baggage net on any airplane.

(i) Service Information

    (1) Diamond Aircraft Industries Mandatory Service Bulletin No.
MSB 40-093, Rev. 0, dated July 6, 2021, for Model DA 40 airplanes.
    (2) Diamond Aircraft Industries Mandatory Service Bulletin No.
MSB F4-039, Rev. 0, dated July 6, 2021, for Model DA 40 F airplanes.
    (3) Diamond Aircraft Industries Mandatory Service Bulletin No.
MSB 40NG-065, Rev. 1, dated July 6, 2021, for Model DA 40 NG
airplanes.

(j) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, New York ACO Branch, FAA, has the authority to
approve AMOCs for this AD, if requested using the procedures found
in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request
to your principal inspector or local Flight Standards District
Office, as appropriate. If sending information directly to the
manager of the certification office, send it to the attention of the
person identified in paragraph (k)(1) of this AD.
    (2) For any requirement in this AD to obtain corrective actions
from a manufacturer, the action must instead be accomplished using a
method approved by the Manager, New York ACO Branch, FAA; or
Transport Canada Civil Aviation (TCCA); or Diamond Aircraft
Industries Inc.'s Design Organization Approval (DAO). If approved by
the DAO, the approval must include the DAO-authorized signature.

(k) Related Information

    (1) For more information about this AD, contact Chirayu Gupta,
Aviation Safety Engineer, New York ACO Branch, FAA, 1600 Stewart
Avenue, Suite 410, Westbury, NY

11590; phone:<PHONE_NUMBER>; email: [email protected]
    (2) Refer to Transport Canada AD CF-2021-24, dated July 21,
2021, for more information. You may view the Transport Canada AD at
https://www.regulations.gov in Docket No. FAA-2022-0450.

(l) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Diamond Aircraft Industries Mandatory Service Bulletin No.
MSB 40-093, Rev. 0, dated July 6, 2021.
    (ii) Diamond Aircraft Industries Mandatory Service Bulletin No.
MSB 40NG-065, Rev. 1, dated July 6, 2021.
    (iii) Diamond Aircraft Industries Mandatory Service Bulletin No.
MSB F4-039, Rev. 0, dated July 6, 2021.
    (3) For service information identified in this AD, contact
Diamond Aircraft Industries Inc., Att: Thit Tun, 1560 Crumlin Road,
London, N5V 1S2, Canada; phone:<PHONE_NUMBER>; email:
[email protected].
    (4) You may view this service information at the FAA,
Airworthiness Products Section, Operational Safety Branch, 901
Locust, Kansas City, MO 64106. For information on the availability
of this material at the FAA, call<PHONE_NUMBER>.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, email: [email protected], or go to: https://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on June 13, 2022.
Christina Underwood,
Acting Director, Compliance & Airworthiness Division, Aircraft
Certification Service.
[FR Doc. 2022-14335 Filed 7-6-22; 8:45 am]
BILLING CODE 4910-13-P


Lydia Wegman/RTP/USEPA/US

03/04/2008 11:55 AM

To

<EMAIL_ADDRESS><EMAIL_ADDRESS> cc

Subject

Meeting at 4 PM today

I wanted to let you know what we'll be in a position to do at our 4 PM meeting.  We have not completed our review of the comments that you faxed to us yesterday.    Based on my conversation with Art yesterday, I understand that Margo has comments that she would prefer to discuss with us, rather than faxing pages to us.   Our expectation is that we will have that discussion today so that we can understand Margo's concerns on uncertainty and whatever other issues she has.  We will be prepared to give you our reactions to the 50-page fax at our 3 PM call tomorrow.


[Federal Register Volume 86, Number 151 (Tuesday, August 10, 2021)]
[Notices]
[Pages 43665-43666]
[FR Doc No: 2021-17045]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2010-N-0190; FDA-2012-N-0197; FDA-2014-N-1414; and
FDA-2014-N-0913]

Agency Information Collection Activities; Announcement of Office
of Management and Budget Approvals

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is publishing a list of
information collections that have been approved by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD

20852,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The following is a list of FDA information
collections recently approved by OMB under section 3507 of the
Paperwork Reduction Act of 1995 (44 U.S.C. 3507). The OMB control
number and expiration date of OMB approval for each information
collection are shown in table 1. Copies of the supporting statements
for the information collections are available on the internet at
https://www.reginfo.gov/public/do/PRAMain. 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.

        Table 1--List of Information Collections Approved by OMB
------------------------------------------------------------------------
                                            OMB control    Date approval
           Title of collection                number          expires
------------------------------------------------------------------------
Infant Formula Requirements.............       0910-0256       5/31/2024
Shortages Data Collection...............       0910-0491       6/30/2024
Guidance on Labeling for Natural Rubber        0910-0633       6/30/2024
 Latex Condoms..........................
Section 513(g) Requests for Information.       0910-0705       6/30/2024
------------------------------------------------------------------------

    Dated: August 5, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-17045 Filed 8-9-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 84, Number 133 (Thursday, July 11, 2019)]
[Notices]
[Pages 33073-33075]
[FR Doc No: 2019-14781]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-1768]

Harmonizing Compendial Standards With Drug Application Approval
Using the United States Pharmacopeial Convention Pending Monograph
Process; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled
``Harmonizing Compendial Standards with Drug Application Approval Using
the USP Pending Monograph Process.'' This guidance assists applicants
(or drug substance master file (MF) holders referenced in an
application) in the

initiation of either revisions to an existing monograph(s) or
development of a new monograph(s) under the United States Pharmacopeial
Convention Pending Monograph Process (USP-PMP) during FDA's evaluation
of a drug substance master file or drug product application. This
guidance describes the process that allows for the revision of
compendial standards that are harmonized with the approved quality and
labeling requirements for a drug product application.

DATES: Submit either electronic or written comments on the draft
guidance by September 9, 2019 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

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

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2019-D-1768 for ``Harmonizing Compendial Standards With Drug
Application Approval Using the USP Pending Monograph Process.''
Received comments will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002; or Policy
and Regulations Staff, HFV-6, Center for Veterinary Medicine, Food and
Drug Administration, 7500 Standish Pl., Rockville, MD 20855. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Lana Bruney, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 4157, Silver Spring, MD 20993-0002, 240-
402-3462; or Mai Huynh, Center for Veterinary Medicine, Food and Drug
Administration, 7500 Standish Pl., Rm. E337, Rockville, MD 20855, 240-
402-0669.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Harmonizing Compendial Standards With Drug Application
Approval Using the USP Pending Monograph Process.'' As part of the
reauthorization of the Generic Drug User Fee Amendments (GDUFA II), FDA
recommitted to promoting the efficiency and effectiveness of the
application review process. Part of the application approval process
includes compliance with the official compendium, the USP-NF (National
Formulary), if applicable. This guidance assists applicants in the
initiation of either revisions to an existing monograph(s) or
development of a new monograph(s) under the USP-PMP during FDA's
evaluation of a drug substance MF or drug product application.
    A drug with a name recognized in the USP-NF must comply with
compendial identity standards or the drug will be deemed adulterated,
misbranded, or both (see section 501(b) and 502(e)(3)(b) and (g) of the
Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 351(b) and
352(e)(3)(b) and (g)); and Sec.  299.5(a) and (b) (21 CFR 299.5(a) and
(b))). Such drugs must also comply with compendial standards for
strength, quality, and purity, unless labeled to show all respects in
which the drug differs, or they will be deemed adulterated (see section
501(b) of the FD&C Act and Sec.  299.5(c)). Before USP-PMP launched, if
during the review of a new drug application (NDA), an abbreviated new
drug application (ANDA), a new animal drug application (NADA), or an
abbreviated new animal drug application (ANADA), it was clear that the
proposed specifications would not comply with the current

monograph, approval of the application and patient access to the drug
were delayed because the USP-NF standards development processes did not
accept proposals from applicants requesting changes to compendial
standards for products that were not currently approved by FDA. If a
monograph needed to be revised to include the applicant's proposed
specifications, there were no mechanisms to do this until after the
application was approved. For approval, the product would have to be
shown to meet the current monograph, at least for identity, and the
product label would have to indicate differences from the monograph
regarding strength, quality, or purity. Typically, the revised
monograph would not become official for 6 months or more. The USP-PMP
was created to address these issues.
    Under the USP-PMP, applicants that have successfully filed an NDA,
ANDA, NADA, or ANADA with FDA and are awaiting review and approval can
propose revisions to an existing monograph or can propose the
publication of a new monograph for an article that is not currently
part of the official compendia. MF holders referenced in a successfully
filed NDA, ANDA, NADA, or ANADA may also propose revisions to an
existing monograph or propose publication of a new monograph for their
drug substance. Immediately following FDA approval of a specific NDA,
ANDA, NADA, or ANADA, USP will make available a revised monograph (or
new monograph, as applicable) harmonized with the application's
approved quality specifications. This process results in the creation
of compendial standards that are harmonized with the quality
specifications in an approved application. (Note: Initiation of the
USP-PMP does not confer Agency acceptability of the compendial
standards proposed for the product, nor preclude full application
evaluation by the Agency; all applications will be subject to complete
evaluation using current established review practices.)
    This guidance details the Agency's expectations for applicants (and
MF holders referenced by applications awaiting approval) who choose to
use the USP-PMP. The document explains how applicants (and MF holders)
should initiate the process, provides Agency recommendations, and
addresses some common situations that may arise during use of the USP-
PMP.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Harmonizing
Compendial Standards With Drug Application Approval Using the USP
Pending Monograph Process.'' It does not establish any rights for any
person and is not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations. This guidance is not subject to Executive
Order 12866.

II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information that are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collections of information relating to NDAs and ANDAs in 21
CFR part 314, including 21 CFR 314.50, 314.94, and 314.420, have been
approved under OMB control number 0910-0001. The collections of
information relating to NADAs in 21 CFR part 514, including 21 CFR
514.1, 514.4, 514.5, 514.6, 514.8, 514.11, and 558.5 have been approved
under OMB control number 0910-0032. The collections of information
relating to ANADAs in sections 512(b)(2) and (n)(1) of the FD&C Act (21
U.S.C. 360b(b)(2) and (n)(1)) have been approved under OMB control
number 0910-0669.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm, or
https://www.regulations.gov.

    Dated: July 8, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-14781 Filed 7-10-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 83, Number 128 (Tuesday, July 3, 2018)]
[Rules and Regulations]
[Pages 31055-31057]
[FR Doc No: 2018-14245]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2018-0606]
RIN 1625-AA00

Safety Zone; Lower Mississippi River, New Orleans, LA

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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

SUMMARY: The Coast Guard is establishing a temporary safety zone for
navigable waters of the Lower Mississippi River between mile markers
(MM) 95.7 and MM 96.7 above Head of Passes in New Orleans, LA. The
safety zone is necessary to protect persons, vessels, and the marine
environment from potential hazards created by a fireworks display.
Entry of vessels or persons into this zone is prohibited unless
specifically authorized by the Captain of the Port Sector New Orleans
or a designated representative.

DATES: This rule is effective from 8:45 p.m. through 9:45 p.m. on July
12, 2018.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to http://www.regulations.gov, type USCG-
2018-0606 in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Lieutenant Commander Howard Vacco, Sector New Orleans,
U.S. Coast Guard; telephone<PHONE_NUMBER>, email
[email protected].

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
COTP Captain of the Port Sector New Orleans
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background Information and Regulatory History

    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(3)(B), the Coast Guard finds that
good cause exists for not publishing a notice of proposed rulemaking
(NPRM) with respect to this rule because it is impracticable It is
impracticable to publish an NPRM because we must establish this safety
zone by July 12, 2018 and lack sufficient time to provide a reasonable
comment period and then consider those comments before issuing the
rule.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Delaying the effective date of
this rule would be contrary to the public interest because immediate
action is necessary to respond to potential hazards associated with the
fireworks display.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 33 U.S.C.
1231. The Captain of the Port Sector New Orleans (COTP) has determined
that potential hazards associated with a fireworks display on July 12,
2018, will be a safety concern for anyone within a one-mile stretch of
the Lower Mississippi River. This rule is necessary to protect persons,
vessels, and the marine environment in the navigable waterway before,
during, and after the fireworks display.

IV. Discussion of the Rule

    This rule establishes a temporary safety zone from 8:45 p.m.
through 9:45 p.m. on July 12, 2018. The safety zone will cover all
navigable waters of the Lower Mississippi River between mile marker
(MM) 95.7 and MM 96.7, above Head of Passes. The duration of the zone
is intended to protect persons, vessels, and the marine environment in
these navigable waters while the fireworks

display is being set up and launched. No vessel or person will be
permitted to enter the safety zone without obtaining permission from
the COTP or a designated representative. A designated representative is
a commissioned, warrant, or petty officer of the U.S. Coast Guard
assigned to units under the operational control of USCG Sector New
Orleans.
    Vessels requiring entry into this safety zone must request
permission from the COTP or a designated representative. They may be
contacted on VHF-FM Channel 16 or 67 or by telephone at<PHONE_NUMBER>.
Persons and vessels permitted to enter this safety zone must transit at
their slowest safe speed and comply with all lawful directions issued
by the COTP or the designated representative. The COTP or a designated
representative will inform the public of the enforcement times and date
for this safety zone through Broadcast Notices to Mariners (BNMs),
Local Notices to Mariners (LNMs), and/or Marine Safety Information
Bulletins (MSIBs) as appropriate.

V. Regulatory Analyses

    We developed this rule after considering numerous statutes and
Executive orders related to rulemaking. Below we summarize our analyses
based on a number of these statutes and Executive orders, and we
discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive Order 13771 directs agencies to control
regulatory costs through a budgeting process. This rule has not been
designated a ``significant regulatory action,'' under Executive Order
12866. Accordingly, this rule has not been reviewed by the Office of
Management and Budget (OMB), and pursuant to OMB guidance it is exempt
from the requirements of Executive Order 13771.
    This regulatory action determination is based on the size,
location, duration, and time-of-day of the safety zone. This safety
zone will restrict traffic on a one-mile portion of the Lower
Mississippi River for one hour on one evening. Moreover, the Coast
Guard will issue a Broadcast Notice to Mariners via VHF-FM marine
channel 16 about the zone, and the rule allows vessels to seek
permission to enter the zone.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. 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.
    While some owners or operators of vessels intending to transit the
temporary safety zone may be small entities, for the reasons stated in
section V.A above, this rule will not have a significant economic
impact on any vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    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.

C. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has 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. We have analyzed this rule under that Order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, 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. If
you believe this rule has implications for federalism or Indian tribes,
please contact the person listed in the FOR FURTHER INFORMATION CONTACT
section above.

E. 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 an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Directive 023-01 and Commandant Instruction M16475.1D, which guide the
Coast Guard in complying with the National Environmental Policy Act of
1969 (42 U.S.C. 4321-4370f), and have determined 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 involves
a safety zone lasting only one hour that will prohibit entry between
mile marker (MM) 95.7 and MM 96.7 on the Lower Mississippi River, above
Head of Passes, before, during and after a fireworks display. It is
categorically excluded from further review under paragraph L(60)a of
Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 01. A
Record of Environmental Consideration supporting this determination is
available in the docket where indicated under ADDRESSES.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.

Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

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; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1,
6.04-6, and 160.5; Department of Homeland Security Delegation No.
0170.1.

0
2. Add Sec.  165.T08-0606 to read as follows:

Sec.  165.T08-0606   Safety Zone; Lower Mississippi River, New Orleans,
LA.

    (a) Location. The following area is a safety zone: All navigable
waters of Lower Mississippi River between mile marker (MM) 95.7 and MM
96.7, near New Orleans, LA.
    (b) Effective period. This section is effective from 8:45 p.m.
through 9:45 p.m. on July 12, 2018.
    (c) Regulations. (1) In accordance with the general regulations in
Sec.  165.23, entry into this zone is prohibited unless authorized by
the Captain of the Port Sector New Orleans (COTP) or designated
representative. A designated representative is a commissioned, warrant,
or petty officer of the U.S. Coast Guard assigned to units under the
operational control of USCG Sector New Orleans.
    (2) Vessels requiring entry into this safety zone must request
permission from the COTP or a designated representative. They may be
contacted on VHF-FM Channel 16 or 67 or by telephone at<PHONE_NUMBER>.
    (3) Persons and vessels permitted to enter this safety zone must
transit at their slowest safe speed and comply with all lawful
directions issued by the COTP or the designated representative.
    (d) Information broadcasts. The COTP or a designated representative
will inform the public of the enforcement times and date for this
safety zone through Broadcast Notices to Mariners (BNMs), Local Notices
to Mariners (LNMs), and/or Marine Safety Information Bulletins (MSIBs)
as appropriate.

    Dated: June 25, 2018.
Kristi M. Luttrell,
Captain, U.S. Coast Guard, Captain of the Port Sector New Orleans.
[FR Doc. 2018-14245 Filed 7-2-18; 8:45 am]
 BILLING CODE 9110-04-P