[Federal Register Volume 83, Number 98 (Monday, May 21, 2018)]
[Rules and Regulations]
[Pages 23371-23372]
[FR Doc No: 2018-10822]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2018-0335]

Safety Zone; Chicago Harbor, Navy Pier Southeast, Chicago, IL

AGENCY: Coast Guard, DHS.

ACTION: Notice of enforcement of regulation.

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SUMMARY: The Coast Guard will enforce the Navy Pier Southeast Safety
Zone within the Chicago Harbor during specified times from May 26, 2018
through January 1, 2019. This action is necessary and intended to
ensure the safety of life and property on navigable waters prior to,
during, and immediately after firework displays. During the enforcement
periods listed below, entry into, transiting, or anchoring within the
safety zone is prohibited unless authorized by the Captain of the Port
Lake Michigan or a designated representative.

DATES: The regulation in 33 CFR 165.931 will be enforced at the times
specified below in SUPPLEMENTARY INFORMATION between May 26, 2018
through January 1, 2019.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
notice of enforcement, call or email LT John Ramos, Waterways
Management Division, Marine Safety Unit Chicago, U.S. Coast Guard;
telephone<PHONE_NUMBER>, email [email protected].

SUPPLEMENTARY INFORMATION: The Coast Guard will enforce Safety Zone;
Chicago Harbor, Navy Pier Southeast, Chicago, IL listed in 33 CFR
165.931, on May 26, 2018 from 10:15 p.m. until 10:30 p.m.; Weekly
events will occur each Saturday starting May 26, 2018 through September
1, 2018 from 10 p.m. until 10:30 p.m.; and each Wednesday starting May
30, 2018 through August 29, 2018 from 9:30 p.m. until 9:45 p.m.
Additionally, this safety zone will also be enforced on July 4, 2018
from 9:30 p.m. until 10 p.m., on September 2, 2018 from 9:30 p.m. until
9:45 p.m., on December 1, 2018 from 9:30 p.m. until 9:45 p.m., and on
December 31, 2018 from 11:45 p.m. until 12:30 a.m. on January 1, 2019.
This safety zone encompasses all waters of Lake Michigan within Chicago
Harbor bounded by coordinates beginning at 41[deg]53'26.5'' N,
087[deg]35'26.5'' W; then south to 41[deg]53'7.6'' N, 087[deg]35'26.3''
W; then west to 41[deg]53'7.6'' N, 087[deg]36'23.2'' W; then north to
41[deg]53'26.5'' N, 087[deg]36'24.6'' W; then east back to the point of
origin (NAD 83). Entry into, transiting, or anchoring within the safety
zone is prohibited unless authorized by the Captain of the Port Lake
Michigan or a designated on-scene representative.
    This notice of enforcement is issued under authority of 33 CFR
165.931 and 5 U.S.C. 552(a). In addition to this notice in the Federal
Register, the Coast Guard will provide the maritime community with
advance notification of the above-specified enforcement periods

of this safety zone via Broadcast Notice to Mariners and Local Notice
to Mariners. The Captain of the Port Lake Michigan or a designated on-
scene representative may be contacted via Channel 16, VHF-FM or at
(414) 747- 7182.

    Dated: May 3, 2018
Thomas J. Stuhlreyer,
Captain, U.S. Coast Guard, Captain of the Port Lake Michigan.
[FR Doc. 2018-10822 Filed 5-18-18; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 87, Number 81 (Wednesday, April 27, 2022)]
[Notices]
[Pages 25028-25029]
[FR Doc No: 2022-08940]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-0412]

Determination That FOLVITE (Folic Acid), Oral Tablets, 1
Milligram, and Other Drug Products, Were Not Withdrawn From Sale for
Reasons of Safety or Effectiveness

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

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) has
determined that the drug products listed in this document were not
withdrawn from sale for reasons of safety or effectiveness. This
determination means that FDA will not begin procedures to withdraw
approval of abbreviated new drug applications (ANDAs) that refer to
these drug products, and it will allow FDA to continue to approve ANDAs
that refer to the products as long as they meet relevant legal and
regulatory requirements.

FOR FURTHER INFORMATION CONTACT: Stacy Kane, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 6236, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: Section 505(j) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)) allows the submission of
an ANDA to market a generic version of a previously approved drug
product. To obtain approval, the ANDA applicant must show, among other
things, that the generic drug product: (1) Has the same active
ingredient(s), dosage form, route of administration, strength,
conditions of use, and (with certain exceptions) labeling as the listed
drug, which is a version of the drug that was previously approved, and
(2) is bioequivalent to the listed drug. ANDA applicants do not have to
repeat the extensive clinical testing otherwise necessary to gain
approval of a new drug application (NDA).
    Section 505(j)(7) of the FD&C Act requires FDA to publish a list of
all approved drugs. FDA publishes this list as part of the ``Approved
Drug Products With Therapeutic Equivalence Evaluations,'' which is
generally known as the ``Orange Book.'' Under FDA regulations, a drug
is removed from the list if the Agency withdraws or suspends approval
of the drug's NDA or ANDA for reasons of safety or effectiveness, or if
FDA determines that the listed drug was withdrawn from sale for reasons
of safety or effectiveness (21 CFR 314.162).
    Under Sec.  314.161(a) (21 CFR 314.161(a)), the Agency must
determine whether a listed drug was withdrawn from sale for reasons of
safety or effectiveness: (1) Before an ANDA that refers to that listed
drug may be approved, (2) whenever a listed drug is voluntarily
withdrawn from sale and ANDAs that refer to the listed drug have been
approved, and (3) when a person petitions for such a determination
under 21 CFR 10.25(a) and 10.30. Section 314.161(d) provides that if
FDA determines that a listed drug was withdrawn from sale for safety or
effectiveness reasons, the Agency will initiate proceedings that could
result in the withdrawal of approval of the ANDAs that refer to the
listed drug.
    FDA has become aware that the drug products listed in the table are
no longer being marketed.

--------------------------------------------------------------------------------------------------------------------------------------------------------
      Application No.             Drug name         Active ingredient(s)       Strength(s)         Dosage form/route                Applicant
--------------------------------------------------------------------------------------------------------------------------------------------------------
NDA 005897................  FOLVITE..............  Folic Acid...........  1 Milligram (mg).....  Tablet; Oral.........  Wyeth Ayerst Pharms.
NDA 005897................  FOLVITE..............  Folic Acid...........  5 mg/Milliliter (mL).  Injectable; Injection  Wyeth Ayerst Pharms.
NDA 014691................  ALKERAN..............  Melphalan............  2 mg.................  Tablet; Oral.........  Apotex Inc.
NDA 015923................  HALDOL...............  Haloperidol Lactate..  Equivalent to (EQ) 5   Injectable; Injection  Janssen Pharms.
                                                                           mg Base/mL.
NDA 016042................  DYAZIDE..............  Hydrochlorothiazide;   25 mg; 50 mg, 25 mg;   Capsule; Oral........  GlaxoSmithKline.
                                                    Triamterene.           37.5 mg.
NDA 017959................  ADRUCIL..............  Fluorouracil.........  50 mg/mL.............  Injectable; Injection  Pharmacia & Upjohn Co.
NDA 017993................  HYDERGINE............  Ergoloid Mesylates...  0.5 mg, 1 mg.........  Tablet; Oral.........  Novartis AG.
NDA 018082................  DEPAKENE.............  Valproic Acid........  250 mg/5 mL..........  Syrup; Oral..........  AbbVie Inc.
NDA 018116................  CYCLOCORT............  Amcinonide...........  0.025%, 0.1%.........  Cream; Topical.......  Astellas.
NDA 018498................  CYCLOCORT............  Amcinonide...........  0.1%.................  Ointment; Topical....  Astellas.
NDA 018985................  ORTHO-NOVUM 7/7/7....  Ethinyl Estradiol;     0.035 mg; 0.5 mg,      Tablet; Oral.........  Janssen Pharms.
                                                    Norethindrone.         0.035 mg; 0.75 mg,
                                                                           0.035 mg; 1 mg.
NDA 019297................  NOVANTRONE...........  Mitoxantrone           EQ 20 mg Base/10 mL,   Injectable; Injection  EMD Serono Inc.
                                                    Hydrochloride.         EQ 2 mg Base/mL.
NDA 019927................  NIZORAL..............  Ketoconazole.........  2%...................  Shampoo; Topical.....  Janssen Pharms.
NDA 020207................  ALKERAN..............  Melphalan              EQ 50 mg Base/Vial...  Injectable; Injection  Apotex Inc.
                                                    Hydrochloride.
NDA 020262................  TAXOL................  Paclitaxel...........  6 mg/mL..............  Injectable; Injection  HQ Specialty Pharma.
NDA 020281................  ULTRAM...............  Tramadol               100 mg...............  Tablet; Oral.........  Janssen Pharms.
                                                    Hydrochloride.
NDA 021692................  ULTRAM ER............  Tramadol               100 mg, 200 mg, 300    Tablet, Extended       Valeant Pharms.
                                                    Hydrochloride.         mg.                    Release; Oral.
NDA 021844................  DESONATE.............  Desonide.............  0.05%................  Gel; Topical.........  Leo Pharma.
NDA 022008................  REQUIP XL............  Ropinirole             EQ 2 mg Base, EQ 4 mg  Tablet, Extended       GlaxoSmithKline LLC.
                                                    Hydrochloride.         Base, EQ 6 mg Base,    Release; Oral.
                                                                           EQ 8 mg Base, EQ 12
                                                                           mg Base.
NDA 050639................  CLEOCIN PHOSPHATE IN   Clindamycin Phosphate  EQ 6 mg Base/mL, EQ    Injectable; Injection  Pfizer.
                             DEXTROSE 5% IN                                12 mg Base/mL, EQ 18
                             PLASTIC CONTAINER.                            mg Base/mL.
NDA 050684................  ZOSYN................  Piperacillin Sodium;   EQ 2 g Base/Vial; EQ   Injectable; Injection  Wyeth Ayerst Pharms.
                                                    Tazobactam Sodium.     250 mg Base/Vial, EQ
                                                                           3 g Base/Vial; EQ
                                                                           375 mg Base/Vial, EQ
                                                                           4 g Base/Vial; EQ
                                                                           500 mg Base/Vial, EQ
                                                                           36 g Base/Vial; EQ
                                                                           4.5 g Base/Vial.
ANDA 062336...............  MUTAMYCIN............  Mitomycin............  40 mg/Vial...........  Injectable; Injection  Bristol-Myers Squibb.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    FDA has reviewed its records and, under Sec.  314.161, has
determined that the drug products listed were not withdrawn from sale
for reasons of safety or effectiveness. Accordingly, the Agency will
continue to list the drug products in the ``Discontinued Drug Product
List'' section of the Orange Book. The ``Discontinued Drug Product
List'' identifies, among other items, drug products that have been
discontinued from marketing for reasons other than safety or
effectiveness.
    Approved ANDAs that refer to the drug products listed are
unaffected by the discontinued marketing of the products subject to
these applications. Additional ANDAs that refer to these products may
also be approved by the Agency if they comply with relevant legal and
regulatory requirements. If FDA determines that labeling for these drug
products should be revised to meet current standards, the Agency will
advise ANDA applicants to submit such labeling.

    Dated: April 21, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-08940 Filed 4-26-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 88, Number 158 (Thursday, August 17, 2023)]
[Notices]
[Page 56014]
[FR Doc No: 2023-17691]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. NJ23-13-000]

Orlando Utilities Commission; Notice of Petition for Declaratory
Order

    Take notice that on July 31, 2023, pursuant to the Federal Energy
Regulatory Commission's (Commission) Rules of Practice and Procedure,
18 CFR 35.28, Orlando Utilities Commission (OUC), submitted a Petition
for Declaratory Order and revisions to its non-jurisdictional Open
Access Transmission Tariff to be effective October 1, 2023.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date. On or
before the comment date, it is not necessary to serve motions to
intervene or protests on persons other than the Petitioner.
    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the ``eFiling'' link
at http://www.ferc.gov. Persons unable to file electronically may mail
similar pleadings to the Federal Energy Regulatory Commission, 888
First Street NE, Washington, DC 20426. Hand delivered submissions in
docketed proceedings should be delivered to Health and Human Services,
12225 Wilkins Avenue, Rockville, Maryland 20852.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://www.ferc.gov) using
the ``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. At this time,
the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance, contact the Federal Energy
Regulatory Commission at [email protected] or call toll-free,
(886) 208-3676 or TYY,<PHONE_NUMBER>.
    The Commission's Office of Public Participation (OPP) supports
meaningful public engagement and participation in Commission
proceedings. OPP can help members of the public, including landowners,
environmental justice communities, Tribal members and others, access
publicly available information and navigate Commission processes. For
public inquiries and assistance with making filings such as
interventions, comments, or requests for rehearing, the public is
encouraged to contact OPP at<PHONE_NUMBER> or [email protected].
    Comment Date: 5:00 p.m. Eastern Time on August 21, 2023.

    Dated: August 11, 2023.
Kimberly D. Bose,
Secretary.
[FR Doc. 2023-17691 Filed 8-16-23; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 222 (Monday, November 22, 2021)]
[Rules and Regulations]
[Pages 66155-66158]
[FR Doc No: 2021-25494]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2021-1008; Project Identifier MCAI-2021-01210-T;
Amendment 39-21828; AD 2021-24-07]
RIN 2120-AA64

Airworthiness Directives; ATR--GIE Avions de Transport
R[eacute]gional Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; request for comments.

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SUMMARY: The FAA is adopting a new airworthiness directive (AD) for
certain ATR--GIE Avions de Transport R[eacute]gional Model ATR42
airplanes and Model ATR72 airplanes. This AD was prompted by a report
of a certain procedure in the aircraft maintenance

manual (AMM) that incorrectly described a visual inspection of the fire
handle. This AD requires a general visual inspection of both engine
fire handles and applicable corrective actions, as specified in a
European Union Aviation Safety Agency (EASA) AD, which is incorporated
by reference. The FAA is issuing this AD to address the unsafe
condition on these products.

DATES: This AD becomes effective November 22, 2021.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of November 22,
2021.
    The FAA must receive comments on this AD by January 6, 2022.

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 EASA material incorporated by reference (IBR) in this AD,
contact EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone
+49 221 8999 000; email [email protected]; 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 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>.

Examining the AD Docket

    You may examine the AD docket at https://www.regulations.gov by
searching for and locating Docket No. FAA-2021-1008; or in person at
Docket Operations between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The AD docket contains this AD, the mandatory
continuing airworthiness information (MCAI), any comments received, and
other information. The street address for Docket Operations is listed
above.

FOR FURTHER INFORMATION CONTACT: Shahram Daneshmandi, Aerospace
Engineer, Large Aircraft Section, FAA, International Validation Branch,
2200 South 216th St., Des Moines, WA 98198; telephone and fax 206-231-
3220; email [email protected].

SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to send any written data, views, or arguments
about this final rule. Send your comments to an address listed under
ADDRESSES. Include ``Docket No. FAA-2021-1008; Project Identifier MCAI-
2021-01210-T'' at the beginning of your comments. The most helpful
comments reference a specific portion of the final rule, 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
this final rule 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 final rule.

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 AD 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 AD, 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 AD. Submissions containing CBI should be sent to Shahram
Daneshmandi, Aerospace Engineer, Large Aircraft Section, FAA,
International Validation Branch, 2200 South 216th St., Des Moines, WA
98198; telephone and fax<PHONE_NUMBER>; email
[email protected]. Any commentary that the FAA receives which
is not specifically designated as CBI will be placed in the public
docket for this rulemaking.

Background

    EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA Emergency AD 2021-0237-E, dated
November 4, 2021 (EASA AD 2021-0237-E) (also referred to as the MCAI),
to correct an unsafe condition for certain ATR--GIE Avions de Transport
R[eacute]gional Model ATR42-200, -300, -320, -400, and -500 airplanes
and Model ATR72-101, -102, -201, -202, -211, -212, and -212A airplanes.
ATR--GIE Avions de Transport R[eacute]gional Model ATR42-400 airplanes
are not certificated by the FAA and are not included on the U.S. type
certificate data sheet; this AD therefore does not include those
airplanes in the applicability.
    This AD was prompted by a report that the AMM maintenance procedure
ATR-A-26-12-60-00ZZZ-281Z-A ``Scheduled Inspection of the Engine Fire
Detection Loops'' incorrectly described a visual inspection of the fire
handle. The maintenance procedure specified to verify that the snap
wire material attaching the fire handle locking hold-plate was a
stainless steel lockwire where it should have specified either an
aluminum snap wire or a copper snap wire. If the engine fire handle
fails, the flightcrew might not be able to extinguish an engine fire
using the engine fire extinguisher system, which is the primary method
for extinguishing engine fires. The FAA is issuing this AD to address
this condition, which, if not detected and corrected, and combined with
an engine fire, could lead to a failure of the engine fire handle to
operate, possibly resulting in an uncontrolled engine fire and reduced
control of the airplane. See the MCAI for additional background
information.

Related Service Information Under 1 CFR Part 51

    EASA AD 2021-0237-E specifies procedures for a general visual
inspection of both engine's fire handles for an incorrect snap wire,
and applicable corrective actions. Corrective actions include removing
the incorrect snap wire, installing the correct snap wire, and
installing the safety seal. 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

    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 described above. The FAA is issuing this AD after determining
that the unsafe condition

described previously is likely to exist or develop on other products of
these same type designs.

Requirements of This AD

    This AD requires accomplishing the actions specified in EASA AD
2021-0237-E described previously, 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 developed a process to use some civil aviation
authority (CAA) ADs as the primary source of information for compliance
with requirements for corresponding FAA ADs. The FAA has been
coordinating this process with manufacturers and CAAs. As a result,
EASA AD 2021-0237-E is incorporated by reference in this AD. This AD
requires compliance with EASA AD 2021-0237-E in its entirety through
that incorporation, except for any differences identified as exceptions
in the regulatory text of this AD. Using common terms that are the same
as the heading of a particular section in EASA AD 2021-0237-E 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
EASA AD 2021-0237-E. Service information required by EASA AD 2021-0237-
E for compliance will be available at https://www.regulations.gov by
searching for and locating Docket No. FAA-2021-1008 after this AD is
published.

FAA's Justification and Determination of the Effective Date

    Section 553(b)(3)(B) of the Administrative Procedure Act (APA) (5
U.S.C. 551 et seq.) authorizes agencies to dispense with notice and
comment procedures for rules when the agency, for ``good cause,'' finds
that those procedures are ``impracticable, unnecessary, or contrary to
the public interest.'' Under this section, an agency, upon finding good
cause, may issue a final rule without providing notice and seeking
comment prior to issuance. Further, section 553(d) of the APA
authorizes agencies to make rules effective in less than thirty days,
upon a finding of good cause.
    An unsafe condition exists that requires the immediate adoption of
this AD without providing an opportunity for public comments prior to
adoption. The FAA has found that the risk to the flying public
justifies foregoing notice and comment prior to adoption of this rule
because if the installation of the incorrect snap wire material on the
engine's fire handles is not detected and corrected, this condition,
combined with an engine fire, could lead to a failure of the engine
fire handle to operate, possibly resulting in an uncontrolled engine
fire and reduced control of the airplane. In addition, the compliance
time for the required action is shorter than the time necessary for the
public to comment and for publication of the final rule. Accordingly,
notice and opportunity for prior public comment are impracticable and
contrary to the public interest pursuant to 5 U.S.C. 553(b)(3)(B).
    In addition, the FAA finds that good cause exists pursuant to 5
U.S.C. 553(d) for making this amendment effective in less than 30 days,
for the same reasons the FAA found good cause to forego notice and
comment.

Regulatory Flexibility Act (RFA)

    The requirements of the RFA do not apply when an agency finds good
cause pursuant to 5 U.S.C. 553 to adopt a rule without prior notice and
comment. Because the FAA has determined that it has good cause to adopt
this rule without notice and comment, RFA analysis is not required.

Costs of Compliance

    The FAA estimates that this AD affects 71 airplanes of U.S.
registry. The FAA estimates the following costs to comply with this AD:

                                      Estimated Costs For Required Actions
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per       Cost on U.S.
                          Labor cost                              Parts cost        product         operators
----------------------------------------------------------------------------------------------------------------
1 work-hour x $85 per hour = $85.............................              $0              $85           $6,035
----------------------------------------------------------------------------------------------------------------

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

                 Estimated Costs of On-Condition Actions
------------------------------------------------------------------------
                                                             Cost per
            Labor cost                  Parts cost           product
------------------------------------------------------------------------
1 work-hour x $85 per hour = $85.  Negligible..........             $85
------------------------------------------------------------------------

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 that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866, and
    (2) Will not affect intrastate aviation in Alaska.

List of Subjects in 14 CFR Part 39

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

The Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13   [Amended]

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

2021-24-07 ATR--GIE Avions de Transport R[eacute]gional: Amendment
39-21828; Docket No. FAA-2021-1008; Project Identifier MCAI-2021-
01210-T.

(a) Effective Date

    This airworthiness directive (AD) is effective November 22,
2021.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to the ATR--GIE Avions de Transport
R[eacute]gional airplanes specified in paragraphs (c)(1) and (2) of
this AD, certificated in any category, as identified in European
Union Aviation Safety Agency (EASA) Emergency AD 2021-0237-E, dated
November 4, 2021 (EASA AD 2021-0237-E).
    (1) Model ATR42-200, -300, -320, and -500 airplanes.
    (2) Model ATR72-101, -102, -201, -202, -211, -212, and -212A
airplanes.

(d) Subject

    Air Transport Association (ATA) of America Code 26, Fire
protection.

(e) Unsafe Condition

    This AD was prompted by a report of a certain procedure in the
aircraft maintenance manual (AMM) that incorrectly described a
visual inspection of the fire handle. The FAA is issuing this AD to
address snap wires made of incorrect material, which, if not
detected and corrected, and combined with an engine fire, could lead
to a failure of the engine fire handle to operate, possibly
resulting in an uncontrolled engine fire and reduced control 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, EASA AD 2021-0237-E.

(h) Exceptions to EASA AD 2021-0237-E

    (1) Where EASA AD 2021-0237-E refers to its effective date, this
AD requires using the effective date of this AD.
    (2) The ``Remarks'' section of EASA AD 2021-0237-E does not
apply to this AD.
    (3) For this AD, the safety seal installation only may be
deferred up to 750 flight hours or 6 months, whichever occurs first,
after the effective date of this AD, if the safety seal is not
available at the time of the snap wire installation.

(i) No Reporting Requirement

    Although the service information referenced in EASA AD 2021-
0237-E specifies to submit certain information to the manufacturer,
this AD does not include that requirement.

(j) Additional 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) 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
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 ATR--GIE
Avions de Transport R[eacute]gional's EASA Design Organization
Approval (DOA). If approved by the DOA, the approval must include
the DOA-authorized signature.

(k) Related Information

    For more information about this AD, contact Shahram Daneshmandi,
Aerospace Engineer, Large Aircraft Section, FAA, International
Validation Branch, 2200 South 216th St., Des Moines, WA 98198;
telephone and fax<PHONE_NUMBER>; email [email protected].

(l) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference 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 this AD specifies otherwise.
    (i) European Union Aviation Safety Agency (EASA) Emergency AD
2021-0237-E, dated November 4, 2021.
    (ii) [Reserved]
    (3) For EASA AD 2021-0237-E, contact EASA, Konrad-Adenauer-Ufer
3, 50668 Cologne, Germany; telephone +49 221 8999 000; email
[email protected]; internet www.easa.europa.eu. You may find this
EASA AD on the EASA website at https://ad.easa.europa.eu.
    (4) 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>.
    (5) You may view this material 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 November 12, 2021.
Gaetano A. Sciortino,
Deputy Director for Strategic Initiatives, Compliance & Airworthiness
Division, Aircraft Certification Service.
[FR Doc. 2021-25494 Filed 11-18-21; 11:15 am]
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