[Federal Register Volume 88, Number 51 (Thursday, March 16, 2023)]
[Notices]
[Pages 16271-16272]
[FR Doc No: 2023-05360]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-0722]

Fresenius Kabi USA, LLC, et al.; Withdrawal of Approval of Six
Abbreviated New Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is
withdrawing approval of six abbreviated new drug applications (ANDAs)
from multiple applicants. The applicants notified the Agency in writing
that the drug products were no longer marketed and requested that the
approval of the applications be withdrawn.

DATES: Approval is withdrawn as of April 17, 2023.

FOR FURTHER INFORMATION CONTACT: Martha Nguyen, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1676, Silver Spring, MD 20993-0002, 240-
402-6980, [email protected].

SUPPLEMENTARY INFORMATION: The applicants listed in the table have
informed FDA that these drug products are no longer marketed and have
requested that FDA withdraw approval of the applications under the
process described in Sec.  314.150(c) (21 CFR 314.150(c)). The
applicants have also, by their requests, waived their opportunity for a
hearing. Withdrawal of approval of an application or abbreviated
application under Sec.  314.150(c) is without prejudice to refiling.

------------------------------------------------------------------------
        Application No.                Drug              Applicant
------------------------------------------------------------------------
ANDA 065111...................  Kanamycin Sulfate  Fresenius Kabi USA,
                                 Injection,         LLC, Three Corporate
                                 Equivalent to      Dr., Lake Zurich, IL
                                 (EQ) 500           60047.
                                 milligrams (mg)
                                 base/2
                                 milliliters (mL)
                                 and EQ 1 gram
                                 (g) base/3 mL.
ANDA 079107...................  Levetiracetam      Tolmar, Inc., 701
                                 Solution, 100 mg/  Centre Ave., Fort
                                 mL.                Collins, CO 80526.
ANDA 201832...................  Nimodipine         Sofgen
                                 Capsules, 30 mg.   Pharmaceuticals,
                                                    LCC, 21500 Biscayne
                                                    Blvd., Suite 600,
                                                    Aventura, FL 33180.
ANDA 202418...................  Lamivudine and     Aurobindo Pharma USA,
                                 Zidovudine         Inc., U.S. Agent for
                                 Tablets, 150 mg;   Aurobindo Pharma
                                 300 mg.            Ltd., 279 Princeton-
                                                    Hightstown Rd., East
                                                    Windsor, NJ 08520.
ANDA 202743...................  Azelastine         Padagis US LLC., U.S.
                                 Hydrochloride      Agent for Padagis
                                 (HCl), Metered     Israel
                                 Spray, 0.2055 mg/  Pharmaceuticals Ltd.
                                 spray.             (formerly known as
                                                    Perrigo Israel
                                                    Pharmaceuticals
                                                    Ltd.), 3940 Quebec
                                                    Avenue North,
                                                    Minneapolis, MN
                                                    55427.
ANDA 203937...................  Fludeoxyglucose    Hot Shots NM, LLC,
                                 F18 Injection, 4-  DBA Midwest Positron
                                 500 millicurie     Technology, LC, 2017
                                 (mCi)/mL.          E Kimberly Rd.,
                                                    Suite C, Davenport
                                                    IA 52807.
------------------------------------------------------------------------

    Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of April
17, 2023. Approval of each entire application is withdrawn, including
any strengths and dosage forms inadvertently missing from the table.
Introduction or delivery for introduction into interstate commerce of
products without approved new drug applications violates section 301(a)
and (d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(a)
and (d)). Drug products that are listed in the table that are in
inventory on April 17, 2023 may continue to be dispensed until the
inventories have been depleted or the drug products have reached their
expiration dates or otherwise become violative, whichever occurs first.

    Dated: March 13, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-05360 Filed 3-15-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 78, Number 116 (Monday, June 17, 2013)]
[Proposed Rules]
[Pages 36129-36131]
[FR Doc No: 2013-14279]

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Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.

========================================================================

Federal Register / Vol. 78, No. 116 / Monday, June 17, 2013 /
Proposed Rules

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2013-0477; Directorate Identifier 2011-SW-015-AD]
RIN 2120-AA64

Airworthiness Directives; Eurocopter France (Eurocopter) Model
Helicopters

AGENCY: Federal Aviation Administration, DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to supersede an existing airworthiness directive
(AD) for Eurocopter Model AS350B, BA, B1, B2, C, D, and D1 helicopters
and Model AS355E, F, F1, F2, and N helicopters with certain part-
numbered tail gearbox (TGB) control levers installed. The existing AD
currently requires repetitive visual inspections of the TGB control
lever for a crack and replacing a cracked TGB control lever with an
airworthy TGB control lever. Since we issued that AD, we have received
reports of cracking on the opposite area of the TGB control lever. This
proposed AD would retain the current requirements and would also
require inspecting other areas of the TGB control lever not previously
inspected and at additional inspection intervals. The proposed actions
are intended to prevent failure of the TGB control lever, loss of tail
rotor control, and subsequent loss of control of the helicopter.

DATES: We must receive comments on this proposed AD by August 16, 2013.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Docket: Go to http://www.regulations.gov. Follow the online instructions for sending your
comments electronically.
     Fax:<PHONE_NUMBER>.
     Mail: Send comments to the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590-0001.
     Hand Delivery: Deliver to the ``Mail'' address between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov or in person at the Docket Operations Office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this proposed AD, the economic
evaluation, any comments received and other information. The street
address for the Docket Operations Office (telephone<PHONE_NUMBER>) is in
the ADDRESSES section. Comments will be available in the AD docket
shortly after receipt.
    For service information identified in this proposed AD, contact
American Eurocopter Corporation, 2701 N. Forum Drive, Grand Prairie, TX
75052; telephone<PHONE_NUMBER> or<PHONE_NUMBER>; fax<PHONE_NUMBER>;
or at http://www.eurocopter.com/techpub.
    You may review service information at the FAA, Office of the
Regional Counsel, Southwest Region, 2601 Meacham Blvd., Room 663, Fort
Worth, Texas 76137.

FOR FURTHER INFORMATION CONTACT: Robert Grant, Aviation Safety
Engineer, Rotorcraft Directorate, Safety Management Group, 2601 Meacham
Blvd., Fort Worth, TX 76137, telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to participate in this rulemaking by submitting
written comments, data, or views. We also invite comments relating to
the economic, environmental, energy, or federalism impacts that might
result from adopting the proposals in this document. The most helpful
comments reference a specific portion of the proposal, explain the
reason for any recommended change, and include supporting data. To
ensure the docket does not contain duplicate comments, commenters
should send only one copy of written comments, or if comments are filed
electronically, commenters should submit only one time.
    We will file in the docket all comments that we receive, as well as
a report summarizing each substantive public contact with FAA personnel
concerning this proposed rulemaking. Before acting on this proposal, we
will consider all comments we receive on or before the closing date for
comments. We will consider comments filed after the comment period has
closed if it is possible to do so without incurring expense or delay.
We may change this proposal in light of the comments we receive.

Discussion

    On August 2, 2010, we issued AD 2010-11-51, Amendment 39-16396 (75
FR 50874, August 18, 2010) for Eurocopter Model AS350B, BA, B1, B2, C,
D, and D1 helicopters and Model AS355E, F, F1, F2, and N helicopters
with certain part-numbered TGB control levers installed. AD 2010-11-51
requires repetitive visual inspections of the TGB control lever for a
crack and replacing a cracked TGB control lever with an airworthy TGB
control lever. AD 2010-11-51 also contains optional terminating actions
for the inspection requirements by either replacing a TBG control lever
with an airworthy TGB control lever that is marked with an ``X'' near
the part number, or stripping and dye-penetrant inspecting the rework
area for a crack and either requires reworking and marking the TGB
control lever if there is no crack or removing and replacing the
cracked TGB control lever if there is a crack. AD 2010-11-51 was
prompted by Emergency AD No. 2010-0082-E, dated April 27, 2010, and
corrected April 28, 2010 (AD No. 2010-0082-E), issued by the European
Aviation Safety Agency (EASA), which is the Technical Agent for Member
States of the European Union. The actions in AD 2010-11-51 are intended
to prevent failure of the TGB control lever, loss of tail rotor
control, and subsequent loss of control of the helicopter.

Actions Since Existing AD Was Issued

    Since we issued AD 2010-11-51 (75 FR 50874, August 18, 2010), we
have received reports of cracking in a TGB control lever on the area
opposite the area required to be inspected. EASA has issued EASA
Emergency AD No. 2011-0038-E, dated March 4, 2011 (AD No. 2011-0038-E),
and superseding EASA

Emergency AD No. 2010-0082-E, to correct an unsafe condition for the
specified Eurocopter model. EASA advises that since issuing EASA
Emergency AD No. 2010-0082-E, Eurocopter found cracks on the area
opposite the area required to be inspected on the affected control
levers. EASA Emergency AD No. 2011-0038-E retains the requirements of
EASA Emergency AD No. 2010-082-E and adds repetitive inspections for
the area opposite the control levers.

FAA's Determination

    These helicopters have been approved by the aviation authority of
France and are approved for operation in the United States. Pursuant to
our bilateral agreement with France, EASA, its technical
representative, has notified us of the unsafe condition described in
its AD. We are proposing this AD because we evaluated all known
relevant information and determined that an unsafe condition is likely
to exist or develop on other helicopters of these same type designs.

Related Service Information

    Eurocopter has issued one Eurocopter Emergency Alert Service
Bulletin (EASB), Revision 2, dated February 28, 2011, with four
different numbers. EASB No. 05.00.62 is for Model AS350 helicopters;
EASB No. 05.00.57 is for Model AS355 helicopters; EASB No. 05.00.38 is
for military Model AS550 helicopters; and EASB No. 05.00.35 is for
military Model AS555 helicopters. The military models are not type-
certificated in the United States. The EASB specifies visually
inspecting the TGB control lever for a crack at the last flight of each
day, without exceeding 10 flying hours between inspections. The EASB
also describes a rework procedure for affected TGB control levers,
which must be done within 660 flying hours and no later than June 30,
2011. Completion of the rework procedure is indicated by marking the
control lever with a letter ``X.'' EASA classified this EASB as
mandatory and issued AD No. 2011-0038-E to ensure the continued
airworthiness of these helicopters.

Proposed AD Requirements

    This proposed AD would retain the requirements in AD 2010-11-51 (75
FR 50874, August 18, 2010) to perform repetitive visual inspections in
a certain area on each TGB control lever not marked with an ``X'' and
would require replacing a cracked part with a part not listed in the
applicability paragraph of the AD. This proposed AD would also require
inspecting another area of each TGB control lever at additional
inspection intervals. Also, this proposed AD would require, within a
specified time, replacing each TGB control lever with a reworked TGB
control lever marked with an ``X'' near the P/N or with a TGB control
lever with a P/N not listed in the applicability of the AD.

Differences Between This Proposed AD and the EASA AD

    This AD differs from EASA Emergency AD No. 2011-0038-E as follows:
     We include the Eurocopter Model AS350C and AS350D1
helicopters that may contain the affected TGB control lever. We do not
include the Eurocopter Model AS350BB helicopter because it is not type-
certificated in the United States.
     We do not require an ``after last flight''of the day
inspection.
     We do not allow a pilot to inspect for a crack.
     We do not require reworking noninstalled control levers.
     We do not include a calendar compliance time for reworking
the TGB control lever if there is not a crack.
     We do not require you to contact Eurocopter if a crack is
found during any inspection.

Costs of Compliance

    We estimate that this proposed AD would affect 791 helicopters of
U.S. registry. We estimate that operators may incur the following costs
in order to comply with this proposed AD: The initial and repetitive
inspections for a crack in the TGB control lever would take a minimal
amount of time. If necessary, replacing a control lever would take
about 3 work hours at an average labor rate of $85 per work hour. The
required parts would cost about $2,103 per helicopter. Based on these
figures, we estimate the total cost of the proposed AD on U.S.
operators would be $2,358 per helicopter to replace the control lever.

Authority for This Rulemaking

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

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed, I certify this proposed regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979);
    3. Will not affect intrastate aviation in Alaska to the extent that
it justifies making a regulatory distinction; and
    4. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared an economic evaluation of the estimated costs to comply
with this proposed AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by removing airworthiness directive (AD)
2010-11-51, Amendment 39-16396 (75 FR 50874, August 18, 2010), and
adding the following new AD:

Eurocopter France: Docket No. FAA-2013-0477; Directorate Identifier
2011-SW-015-AD.

(a) Applicability

    This AD applies to Model AS350B, BA, B1, B2, C, D, and D1
helicopters and Model

AS355E, F, F1, F2, and N helicopters, with a tail gearbox (TGB)
control lever, part number (P/N) 350A33-1058-00, P/N 350A33-1058-01,
P/N 350A33-1058-02, or P/N 350A33-1058-03, both with and without an
``X'' marked near the P/N, installed, certificated in any category.

(b) Unsafe Condition

    This AD defines the unsafe condition as a crack in the TGB
control lever. This condition could result in failure of the TGB
control lever, loss of tail rotor control, and subsequent loss of
control of the helicopter.

(c) Affected ADs

    This AD supersedes AD 2010-11-51, Amendment 39-16396 (75 FR
50874, August 18, 2010).

 (d) Comments Due Date

    We must receive comments by August 16, 2013.

(e) Compliance

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

(f) Required Actions

    (1) For helicopters with a lever not marked with an ``X'' near
the P/N, within 10 hours time-in-service (TIS), and thereafter at
intervals not to exceed 10 hours TIS, using a mirror and appropriate
light source, visually inspect the TGB control lever for a crack as
shown in area ``A'' of Figure 2 of Eurocopter Emergency Alert
Service Bulletin (EASB), Revision 2, dated February 28, 2011, No.
05.00.62 for Model AS350 helicopters and No. 05.00.57 for Model
AS355 helicopters (EASB). If there is a crack, before further
flight, replace each cracked TGB control lever with a TGB control
lever with a P/N not listed in paragraph (a) of this AD.
    (2) For Model AS355N helicopters, within 110 hours TIS, or if
the helicopter has reached 100 or more hours TIS, within the next 10
hours TIS, and thereafter at intervals not to exceed 110 hours TIS,
using a mirror and appropriate light source, inspect each TGB
control lever for a crack as shown in area ``C'' of Figure 8 of the
EASB.
    (3) Within 660 hours TIS, replace each TGB control lever with a
reworked TGB control lever marked with an ``X'' near the P/N or with
a TGB control lever with a P/N not listed in paragraph (a) of this
AD.
    (4) For all model helicopters except Model AS355N, within 660
hours TIS, or if the helicopter has reached 605 or more hours TIS
within the next 55 hours TIS, and thereafter at intervals not to
exceed 660 hours TIS, using a mirror and appropriate light source,
inspect each TGB control lever for a crack as shown in area ``C'' of
figure 8 of the EASB.
    (5) If there is a crack, before further flight, replace each
cracked TGB control lever with a TGB control lever with a P/N not
listed in paragraph (a) of this AD.

(g) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Safety Management Group, FAA, may approve AMOCs
for this AD. Send your proposal to: Robert Grant, Aviation Safety
Engineer, FAA, Rotorcraft Directorate, Safety Management Group, 2601
Meacham Blvd., Fort Worth, TX 76137, telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>    (2) For operations conducted under a 14 CFR part 119 operating
certificate or under 14 CFR part 91, subpart K, we suggest that you
notify your principal inspector, or lacking a principal inspector,
the manager of the local flight standards district office or
certificate holding district office before operating any aircraft
complying with this AD through an AMOC.

(h) Additional Information

    (1) Eurocopter Alert Service Bulletin No. 05.00.62 and No.
05.00.57, Revision 2, dated February 28, 2011, are co-published as
one document along with EASB No. 05.00.38 and EASB No. 05.00.35,
which are not incorporated by reference in this AD.
    (2) For service information identified in this AD, contact
American Eurocopter Corporation, 2701 N. Forum Drive, Grand Prairie,
TX 75052; telephone<PHONE_NUMBER> or<PHONE_NUMBER>; fax (972) 641-
3775; or at http://www.eurocopter.com/techpub. You may review a copy
of the service information at the FAA, Office of the Regional
Counsel, Southwest Region, 2601 Meacham Blvd., Room 663, Fort Worth,
Texas 76137.
    (3) The subject of this AD is addressed in European Aviation
Safety Agency Emergency AD No. 2011-0038-E, dated March 4, 2011.

(i) Subject

    Joint Aircraft Service Component (JASC) Code: 6720 Tail Rotor
Control System.

    Issued in Fort Worth, Texas, on May 28, 2013.
Kim Smith,
Directorate Manager, Rotorcraft Directorate, Aircraft Certification
Service.
[FR Doc. 2013-14279 Filed 6-14-13; 8:45 am]
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[Federal Register: August 27, 2009 (Volume 74, Number 165)]
[Notices]
[Page 43696]
[DOCID:fr27au09-70]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP09-809-000]

Maritimes & Northeast Pipeline, L.L.C.; Notice of Technical
Conference

August 20, 2009.
    Take notice that Commission Staff will convene a technical
conference in the above-referenced proceeding on Friday, September 11,
2009, at 10 a.m. (EST), in a room to be designated at the offices of
the Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426.
    On July 1, 2009, Maritimes & Northeast Pipeline, L.L.C. (Maritimes)
filed revised tariff sheets to, among other things, reflect out-of-
cycle changes in Maritimes' Fuel Retainage Quantity. On July 30, 2009,
the Commission accepted and suspended Maritimes proposed tariff sheets
revising Maritimes' fuel rate methodology and increasing its fuel
charges, to become effective January 1, 2010, subject to refund and the
outcome of a technical conference. During the technical conference,
Commission Staff and interested persons will have the opportunity to
discuss all of the issues raised by Maritimes' out-of-cycle fuel
filing.
    FERC conferences are accessible under section 508 of the
Rehabilitation Act of 1973. For accessibility accommodations please
send an e-mail to<EMAIL_ADDRESS>or call toll free (866) 208-
3372 (voice) or<PHONE_NUMBER> (TTY), or send a fax to<PHONE_NUMBER>
with the required accommodations.
    All interested persons are permitted to attend. For further
information please contact Anna Fernandez at<PHONE_NUMBER> or e-mail
<EMAIL_ADDRESS>
Kimberly D. Bose,
Secretary.
[FR Doc. E9-20642 Filed 8-26-09; 8:45 am]

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