[Federal Register Volume 82, Number 105 (Friday, June 2, 2017)]
[Proposed Rules]
[Pages 25552-25554]
[FR Doc No: 2017-11003]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2017-0514; Directorate Identifier 2016-NM-206-AD]
RIN 2120-AA64

Airworthiness Directives; Airbus Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to adopt a new airworthiness directive (AD) for all
Airbus Model A300 B4-600, B4-600R, and F4-600R series airplanes, and
Model A300 C4-605R Variant F airplanes (collectively called Model A300-
600 series airplanes). This proposed AD was prompted by a revision of
certain airworthiness limitation item (ALI) documents, which require
more restrictive maintenance requirements and airworthiness
limitations. This proposed AD would require revising the maintenance or
inspection program, as applicable, to incorporate new maintenance
requirements and airworthiness limitations. We are proposing this AD to
address the unsafe condition on these products.

DATES: We must receive comments on this proposed AD by July 17, 2017.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For service information identified in this NPRM, contact Airbus
SAS, Airworthiness Office--EAW, 1 Rond Point Maurice Bellonte, 31707
Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 44
51; email<EMAIL_ADDRESS>Internet http://www.airbus.com. You may view this referenced service information at the
FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA.
For information on the availability of this material at the FAA, call
425-227-1221.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-
0514; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this proposed AD, the regulatory 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 FURTHER INFORMATION CONTACT: Dan Rodina, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue SW., Renton, WA 98057-3356; telephone<PHONE_NUMBER>;
fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2017-0514;
Directorate Identifier 2016-NM-206-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD based on those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Union, has issued EASA AD
2016-0218, dated November 2, 2016 (referred to after this as the
Mandatory Continuing Airworthiness Information, or ``the MCAI''), to
correct an unsafe condition for all Airbus Model A300 B4-600, B4-600R,
and F4-600R series airplanes, and Model A300 C4-605R Variant F
airplanes (collectively called Model A300-600 series airplanes). The
MCAI states:

    The airworthiness limitations for Airbus A300-600 aeroplanes,
which are approved by EASA, are currently defined and published in
the Airbus A300-600 Airworthiness Limitations Section (ALS)
document(s). These instructions have been identified as mandatory
actions for continued airworthiness.
    Failure to accomplish these instructions could result in an
unsafe condition.
    EASA previously issued [EASA] AD 2014-0124 (later revised)[which
includes actions for Airbus A300-600 airplanes; those actions are
included in FAA AD 2013-13-13, Amendment 39-17501 (79 FR 48957,
August 19, 2014) (``AD 2013-13-13'')], requiring the actions
described in Airbus A300-600 Airworthiness Limitation Item (ALI)
Document at issue 13 and Temporary Revision (TR) 13.1.
    Since EASA AD 2014-0124R1 was issued, Airbus replaced A300-600
ALI Document issue 13, with A300-600 ALS Part 2 Revision 01 and then
published the A300-600 ALS Part 2 Variation 1.1 and Variation 1.2,
to introduce more restrictive maintenance requirements and/or
airworthiness limitations.
    A300-600 ALS Part 2 Variation 1.1 also includes ALI 571067 and
ALI 571068, superseding Service Bulletin A300-53-6154, which is
referenced in EASA AD 2006-0257

[which corresponds to FAA AD 2007-22-05, Amendment 39-15241 (72 FR
60236, October 24, 2007) (``AD 2007-22-05'')].
    For the reasons described above, this [EASA] AD retains part of
the requirements of EASA AD 2014-0124R1, which will be superseded,
and requires accomplishment of the actions specified in Airbus A300-
600 ALS Part 2 Revision 01, and ALS Part 2 Variation 1.1 and ALS
Part 2 Variation 1.2 (hereafter collectively referred to as `the
ALS' in this [EASA] AD), and supersedes EASA AD 2006-0257. The
remaining requirements of EASA AD 2014-0124R1 are retained in AD
2016-0217, applicable to A310 aeroplanes, published at the same time
as this [EASA] AD.

    You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-
0514.

Related Service Information Under 1 CFR Part 51

    We reviewed the following service information:
     Airbus A300-600 Airworthiness Limitations Section (ALS),
Part 2, ``Damage Tolerant Airworthiness Limitation Items (DT-ALI),''
Revision 01, dated August 7, 2015.
     Airbus A300-600 Airworthiness Limitations Section (ALS),
Part 2, ``Damage Tolerant Airworthiness Limitation Items (DT-ALI),''
Variation 1.1, dated January 25, 2016.
     Airbus A300-600 Airworthiness Limitations Section (ALS),
Part 2, ``Damage Tolerant Airworthiness Limitation Items (DT-ALI),''
Variation 1.2, dated July 22, 2016.
    The service information describes airworthiness limitations
applicable to the DT ALIs. These documents are distinct because they
contain unique tasks. This service information is reasonably available
because the interested parties have access to it through their normal
course of business or by the means identified in the ADDRESSES section.

FAA's Determination 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 our bilateral agreement with the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI and service
information referenced above. We are proposing this AD because we
evaluated all pertinent information and determined an unsafe condition
exists and is likely to exist or develop on other products of the same
type design.
    This NPRM would not supersede AD 2007-22-05 and AD 2013-13-13.
Rather, we have determined that a stand-alone AD would be more
appropriate to address the changes in the MCAI. This NPRM would require
revising the maintenance or inspection program to incorporate the new
maintenance requirements and airworthiness limitations. Accomplishment
of the proposed actions would then terminate all the requirements of AD
2007-22-05 and AD 2013-13-13.
    This AD requires revisions to certain operator maintenance
documents to include new actions (e.g., inspections). Compliance with
these actions is required by 14 CFR 91.403(c). For airplanes that have
been previously modified, altered, or repaired in the areas addressed
by this proposed AD, the operator may not be able to accomplish the
actions described in the revisions. In this situation, to comply with
14 CFR 91.403(c), the operator must request approval for an alternative
method of compliance according to paragraph (j)(1) of this proposed AD.
The request should include a description of changes to the required
actions that will ensure the continued damage tolerance of the affected
structure.

Costs of Compliance

    We estimate that this proposed AD affects 128 airplanes of U.S.
registry.
    We estimate the following costs to comply with this proposed AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
              Action                      Labor cost             Parts cost           product        operators
----------------------------------------------------------------------------------------------------------------
Maintenance program revision......  1 work-hour x $85 per  None.................             $85         $10,880
                                     hour = $85.
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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 above, I certify this proposed
regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979);
    3. Will not affect intrastate aviation in Alaska; and
    4. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13   [Amended]

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

Airbus: Docket No. FAA-2017-0514; Directorate Identifier 2016-NM-
206-AD.

(a) Comments Due Date

    We must receive comments by July 17, 2017.

(b) Affected ADs

    This AD affects AD 2007-22-05, Amendment 39-15241 (72 FR 60236,
October 24, 2007) (``AD 2007-22-05'') and AD 2013-13-13, Amendment
39-17501 (79 FR 48957, August 19, 2014) (``AD 2013-13-13'').

(c) Applicability

    This AD applies to all Airbus Model A300 B4-601, B4-603, B4-620,
B4-622, B4-605R, B4-622R, F4-605R, F4-622R, and C4-605R Variant F
airplanes, certificated in any category, all manufacturer serial
numbers.

(d) Subject

    Air Transport Association (ATA) of America Code 05, Time limits/
maintenance checks.

(e) Reason

    This AD was prompted by a revision of certain airworthiness
limitation item (ALI) documents, which require more restrictive
maintenance requirements and airworthiness limitations. We are
issuing this AD to prevent fatigue cracking, damage, or corrosion in
principal structural elements, which could result in reduced
structural integrity of the airplane.

(f) Compliance

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

(g) Revision of Maintenance or Inspection Program

    Within 3 months after the effective date of this AD, revise the
maintenance or inspection program, as applicable, to incorporate the
information specified in paragraphs (g)(1), (g)(2), and (g)(3) of
this AD. The initial compliance times for doing the tasks are at the
time specified in the service information identified in paragraphs
(g)(1), (g)(2), and (g)(3) of this AD, or within 3 months after the
effective date of this AD, whichever occurs later.
    (1) Airbus A300-600 Airworthiness Limitations Section (ALS),
Part 2, ``Damage Tolerant Airworthiness Limitation Items (DT-ALI),''
Revision 01, dated August 7, 2015.
    (2) Airbus A300-600 Airworthiness Limitations Section (ALS),
Part 2, ``Damage Tolerant Airworthiness Limitation Items (DT-ALI),''
Variation 1.1, dated January 25, 2016.
    (3) Airbus A300-600 Airworthiness Limitations Section (ALS),
Part 2, ``Damage Tolerant Airworthiness Limitation Items (DT-ALI),''
Variation 1.2, dated July 22, 2016.

(h) No Alternative Actions or Intervals

    After the maintenance or inspection program has been revised as
required by paragraph (g) of this AD, no alternative actions (e.g.,
inspections), or intervals, may be used unless the actions, or
intervals, are approved as an alternative method of compliance
(AMOC) in accordance with the procedures specified in paragraph
(j)(1) of this AD.

(i) Terminating Actions

    Accomplishing the actions required by this AD terminates all of
the requirements of AD 2007-22-05 and AD 2013-13-13 for that
airplane only.

(j) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, Transport Airplane Directorate, 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 International Branch, send it to the
attention of the person identified in paragraph (k)(2) of this AD.
Before using any approved AMOC, notify your appropriate principal
inspector, or lacking a principal inspector, the manager of the
local flight standards district office/certificate holding district
office.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain corrective actions from a manufacturer, the action must be
accomplished using a method approved by the Manager, International
Branch, ANM-116, Transport Airplane Directorate, FAA; or the
European Aviation Safety Agency (EASA); or Airbus's EASA Design
Organization Approval (DOA). If approved by the DOA, the approval
must include the DOA-authorized signature.

(k) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) EASA Airworthiness Directive 2016-0218, dated November 2,
2016, for related information. This MCAI may be found in the AD
docket on the Internet at http://www.regulations.gov by searching
for and locating Docket No. FAA-2017-0514.
    (2) For more information about this AD, contact Dan Rodina,
Aerospace Engineer, International Branch, ANM-116, Transport
Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-
3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>. Information may be
emailed to<EMAIL_ADDRESS>    (3) For service information identified in this AD, contact
Airbus SAS, Airworthiness Office--EAW, 1 Rond Point Maurice
Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96;
fax +33 5 61 93 44 51; email<EMAIL_ADDRESS>
Internet http://www.airbus.com. You may view this service
information at the FAA, Transport Airplane Directorate, 1601 Lind
Avenue SW., Renton, WA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.

    Issued in Renton, Washington, on May 18, 2017.
Michael Kaszycki,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2017-11003 Filed 6-1-17; 8:45 am]
BILLING CODE 4910-13-P


BEFORE THE

DEPARTMENT OF TRANSPORTATION

WASHINGTON, D.C.

								_

Joint Applications of		 )

		 )

DELTA AIR LINES, INC.,		 )

ATLANTIC SOUTHEAST AIRLINES, INC. and	 )

COMAIR, INC.		 )

		 )

and		 )	Docket OST-2000-8207

		 )

CZECH AIRLINES		 )

for statements of authorization		 )

pursuant to 14 C.F.R. Part 212		 )

(United States-Czech Republic blanket codesharing )

30-DAY NOTICE

Communications with respect to this document should be sent to:

Allan I. Mendelsohn			D. Scott Yohe

Constance O’Keefe			Senior Vice President - Government Affairs

MENDELSOHN & O’KEEFE		DELTA AIR LINES, INC.

1201 Connecticut Avenue, N.W.		1275 K Street, N.W.

Suite 850					Washington, D.C. 20005

Washington, D.C. 20036<PHONE_NUMBER>
<PHONE_NUMBER>

Counsel for					John Varley, Assistant General Counsel

CZECH AIRLINES			James Coblin, Attorney

						DELTA AIR LINES, INC.

						Law Department #981

						1030 Delta Boulevard

						Atlanta, GA 30320

<PHONE_NUMBER>

						Robert E. Cohn

						Alexander Van der Bellen

						SHAW PITTMAN LLP

						2300 N Street, N.W.

						Washington, D.C. 20037-1128

<PHONE_NUMBER>

						Counsel for

						DELTA AIR LINES, INC.

				ATLANTIC SOUTHEAST AIRLINES, INC.

April 12, 2002				COMAIR, INC.

BEFORE THE

DEPARTMENT OF TRANSPORTATION

WASHINGTON, D.C.

								_

Joint Applications of		 )

		 )

DELTA AIR LINES, INC.,		 )

ATLANTIC SOUTHEAST AIRLINES, INC. and	 )

COMAIR, INC.		 )

		 )

and		 )	Docket OST-2000-8207

		 )

CZECH AIRLINES		 )

for statements of authorization		 )

pursuant to 14 C.F.R. Part 212		 )

(United States-Czech Republic blanket codesharing )

30-DAY NOTICE

The Department has established this consolidated docket for the
administration of the blanket codeshare statements of authorization held
by Delta Air Lines, Inc. (“Delta”), Czech Airlines (“CSA”) and
Delta’s connection carrier affiliates, Atlantic Southeast Airlines,
Inc. (“ASA”) and Comair, Inc. (“Comair”).  Pursuant to the
blanket statements of authorization granted to Delta and CSA (February
27, 2001), CSA and Comair (March 16, 2001), and CSA and ASA (March 16,
2001), Delta, CSA, ASA and Comair submit this 30-day notice of
additional codesharing as set forth below.

1.	Effective June 15, 2002, CSA plans to display its “OK” designator
code on flights operated by Comair between New York (JFK) and
Philadelphia (PHL).

2.	In addition, Delta hereby notifies the Department that notice given
for a service point by Delta or either of its connection carrier
affiliates, ASA and Comair, should be deemed notice given for all three
carriers.  This will assist Delta in maintaining the most efficient
allocation of flying between mainline and connection carriers, without
undue administrative burdens.  The Department has previously granted
Delta and other carriers similar flexibility.  See, e.g., Department
Action on Delta/SAA/Comair Application in Docket OST-99-6556 (August 27,
2001).

3.	Similarly, Delta and CSA notify the Department that notice given for
any domestic U.S. or beyond service point should be deemed notice for
service via any or all of Delta’s and CSA’s authorized U.S.
transatlantic gateways.  The Department has allowed similar flexibility
to blanket statement of authorization holders from other open skies
countries.  See, e.g., Delta/ASA/Comair/Alitalia, Docket OST-2001-10417.

4.	This 30-day notice and integration of previously-issued blanket
codeshare authorities will simplify and reduce the burden on Delta, CSA
and the Department in maintaining the above-referenced codeshare
statements of authorization.

Respectfully submitted,

	/s/						/s/

Allan I. Mendelsohn	Robert E. Cohn

Constance O’Keefe 	Alexander Van der Bellen

MENDELSOHN & O’KEEFE	SHAW PITTMAN LLP

1201 Connecticut Avenue, N.W.	2300 N Street, N.W.

Suite 850	Washington, D.C. 20037-1128

Washington, D.C. 20036<PHONE_NUMBER>

(202) 775-0680

	Counsel for

Counsel for	DELTA AIR LINES, INC.

CZECH AIRLINES	ATLANTIC SOUTHEAST AIRLINES, INC.

	COMAIR, INC.

Footnote continued from previous page

Footnote continued on next page

30-Day Notice

Page   PAGE  3


[Federal Register Volume 88, Number 34 (Tuesday, February 21, 2023)]
[Notices]
[Pages 10522-10523]
[FR Doc No: 2023-03516]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-P-1939]

Determination That TOPAMAX (Topiramate) Sprinkle Capsules, 50
Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or
Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) has
determined that TOPAMAX (topiramate) sprinkle capsules, 50 milligrams
(mg), was not withdrawn from sale for reasons of safety or
effectiveness. This determination will allow FDA to approve abbreviated
new drug applications (ANDAs) for topiramate, sprinkle capsules, 50 mg,
if all other legal and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Alexandria Fujisaki, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6222,

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
known generally as the ``Orange Book.'' Under FDA regulations, drugs
are 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 (Sec.  314.162 (21 CFR 314.162)).
    A person may petition the Agency to determine, or the Agency may
determine on its own initiative, whether a listed drug was withdrawn
from sale for reasons of safety or effectiveness. This determination
may be made at any time after the drug has been withdrawn from sale,
but must be made prior to approving an ANDA that refers to the listed
drug (Sec.  314.161 (21 CFR 314.161)). FDA may not approve an ANDA that
does not refer to a listed drug.
    TOPAMAX (topiramate) sprinkle capsules, 50 mg, is the subject of
NDA 020844, held by Janssen Pharmaceuticals, Inc., and initially
approved on October 26, 1998. TOPAMAX is indicated for epilepsy
(initial monotherapy for the treatment of partial-onset or primary
generalized tonic-clonic seizures in patients 2 years of age and older;
adjunctive therapy for the treatment of partial-onset seizures, primary
generalized tonic-clonic seizures, or seizures associated with Lennox-
Gastaut syndrome in patients 2 years of age and older) and preventive
treatment of migraine in patients 12 years of age and older.
    Janssen Pharmaceuticals, Inc., has never marketed TOPAMAX
(topiramate) sprinkle capsules, 50 mg. In previous instances (see,
e.g., 72 FR 9763, March 5, 2007; 61 FR 25497, May 21, 1996), the Agency
has determined that, for purposes of Sec. Sec.  314.161 and 314.162,
never marketing an approved drug product is equivalent to withdrawing
the drug from sale.
    Hyman, Phelps & McNamara, P.C. submitted a citizen petition dated
August 17, 2022 (Docket No. FDA-2022-P-1939), under 21 CFR 10.30,
requesting that the Agency determine whether TOPAMAX (topiramate)
sprinkle capsules, 50 mg, was withdrawn from sale for reasons of safety
or effectiveness.
    After considering the citizen petition and reviewing Agency records
and based on the information we have at this time, FDA has determined
under Sec.  314.161 that TOPAMAX (topiramate) sprinkle capsules, 50 mg,
was not withdrawn for reasons of safety or effectiveness. The
petitioner has identified no data or other information suggesting that
TOPAMAX (topiramate) sprinkle capsules, 50 mg, was withdrawn for
reasons of safety or effectiveness. We have carefully reviewed our
files for records concerning the withdrawal of TOPAMAX (topiramate)
sprinkle capsules, 50 mg, from sale. We have also independently
evaluated relevant literature and data for possible postmarketing
adverse events. We have found no information that would indicate that
this drug product was withdrawn from sale for reasons of safety or
effectiveness.
    Accordingly, the Agency will continue to list TOPAMAX (topiramate)
sprinkle capsules, 50 mg, in the ``Discontinued Drug Product List''
section of the Orange Book. The ``Discontinued Drug Product List''
delineates, among other items, drug products that have been
discontinued from marketing for reasons other than safety or
effectiveness. ANDAs that refer to TOPAMAX (topiramate) sprinkle
capsules, 50 mg, may be approved by the Agency as long as they meet all
other legal and regulatory requirements for the approval of ANDAs. If
FDA determines that labeling for this drug product should be revised to
meet current standards, the Agency will advise ANDA applicants to
submit such labeling.

    Dated: February 15, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-03516 Filed 2-17-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 80, Number 68 (Thursday, April 9, 2015)]
[Notices]
[Pages 19084-19085]
[FR Doc No: 2015-08211]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2015-0021; FRL-9924-20]

Pesticide Product Registration; Receipt of Applications for New
Active Ingredients

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: EPA has received applications to register pesticide products
containing active ingredients not included in any currently registered
pesticide products. Pursuant to the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA), EPA is hereby providing notice of receipt and
opportunity to comment on these applications.

DATES: Comments must be received on or before May 11, 2015.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number and the File Symbol of interest as shown in the body of
this document, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at  http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Jennifer Mclain, Antimicrobials
Division (AD) (7510P), main telephone number:<PHONE_NUMBER>; email
address<EMAIL_ADDRESS>Susan Lewis, Registration Division (RD)
(7505P), main telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>The mailing address for each contact person is:
Office of Pesticide Programs, Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001. As part of the
mailing address, include the contact person's name, division, and mail
code. The division to contact is listed at the end of each application
summary.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.

II. Registration Applications

    EPA has received applications to register pesticide products
containing active ingredients not included in any currently registered
pesticide products. Pursuant to the provisions of FIFRA section 3(c)(4)
(7 U.S.C. 136a(c)(4)), EPA is hereby providing notice of receipt and
opportunity to comment on these applications. Notice of receipt of
these applications does not imply a decision by the Agency on these
applications.
    1. File Symbol: 707-GEL. Docket ID Number: EPA-HQ-OPP-2010-1037.
Applicant: Rohm and Hass Company, 100 Independence Mall West,
Philadelphia, PA 19106. Product name: Bioban 557 Antimicrobial. Active
ingredient: 2-Methyl-1, 2-benzisothiazol-3 (2H)-one at 9%. Proposed
classification/Use: ATD emulsion products, paints, building materials,
adhesives and sealants, ink, textiles, paper coating, functional
chemicals, household and I&I, oil process water and recovery system,
metalworking fluids. Contact: AD.
    2. File Symbol: 4091-RL. Docket ID number: EPA-HQ-OPP-2014-0921.
Applicant: W.M. Barr & Company, Inc., 6750 Lenox Center Court, Suite
200, Memphis, TN 38115. Product name: FG0. Active ingredient:
Antimicrobial, calcium chloride at 78%. Proposed classification/Use:
Manufacturing use product. Contact: AD.
    3. File Symbol: 4091-RA. Docket ID number: EPA-HQ-OPP-2014-0921.
Applicant: W.M. Barr & Company, Inc., 6750 Lenox Center Court, Suite
200, Memphis, TN 38115. Product name: FG1. Active ingredient:
Antimicrobial, calcium chloride at 77%. Proposed classification/Use:
End-use product for use as a moisture absorber in enclosed spaces to
retard growth mold, mildew, and bacteria. Contact: AD.
    4. File Symbol: 4091-RT. Docket ID number: EPA-HQ-OPP-2014-0921.
Applicant: W.M. Barr & Company, Inc., 6750 Lenox Center Court, Suite
200, Memphis, TN 38115. Product name: FG2. Active ingredient:
Antimicrobial, calcium chloride at 73%. Proposed classification/Use:
End-use product for use as a moisture absorber in enclosed spaces to
retard growth mold, mildew, and bacteria. Contact: AD.
    5. File Symbol: 4091-RI. Docket ID number: EPA-HQ-OPP-2014-0921.
Applicant: W.M. Barr & Company, Inc., 6750 Lenox Center Court, Suite
200, Memphis, TN 38115. Product name: FG3. Active ingredient:
Antimicrobial, calcium chloride at 58%. Proposed classification/Use:
End-use product for use as a moisture absorber in enclosed spaces to
retard growth mold, mildew, and bacteria. Contact: AD.
    6. File Symbol: 71512-ET. Docket ID number: EPA-HQ-OPP-2014-0679.
Applicant: ISK Biosciences Corporation, 7470 Auburn Road, Suite A,
Concord, OH 44077. Product name: Technical Cyclaniliprole Insecticide.
Active ingredient: Insecticide Cyclaniliprole at 96.4%. Proposed
classification/Use: Pome fruit (Crop Group 11-11), tree nuts (Crop
Group 14-12), stone fruit (Crop Group 12-12), fruiting vegetables (Crop
Group 8-10), cucurbit vegetables

(Crop Group 9), small fruit vine climbing Crop Subgroup including
grapes (Crop Subgroup 13-07F), proposed Crop Subgroup 4-14A; leafy
green subgroup, proposed Crop Subgroup 4-14B; brassica leafy greens
subgroup, proposed Crop Subgroup 22B; leaf petiole vegetable subgroup,
proposed Crop Group 5-14; brassica head and stem vegetables, and import
tolerance for tea. Contact: RD.
    7. File Symbol: 71512-EA. Docket ID number: EPA-HQ-OPP-2014-0679.
Applicant: ISK Biosciences Corporation, 7470 Auburn Road, Suite A,
Concord, OH 44077. Product names: Cyclaniliprole 50 SL Insecticide.
Active ingredient: Insecticide Cyclaniliprole at 4.55%. Proposed
classification/Use: Pome fruit (Crop Group 11-11), tree nuts (Crop
Group 14-12), stone fruit (Crop Group 12-12), fruiting vegetables (Crop
Group 8-10), cucurbit vegetables (Crop Group 9), small fruit vine
climbing Crop Subgroup including grapes (Crop Subgroup 13-07F),
proposed Crop Subgroup 4-14A; leafy green subgroup, proposed Crop
Subgroup 4-14B; brassica leafy greens subgroup, proposed Crop Subgroup
22B; leaf petiole vegetable subgroup, proposed Crop Group 5-14;
brassica head and stem vegetables, and import tolerance for tea.
Contact: RD.

    Authority:  7 U.S.C. 136 et seq.

    Dated: April 1, 2015.
Susan Lewis,
Director, Registration Division, Office of Pesticide Programs.
[FR Doc. 2015-08211 Filed 4-8-15; 8:45 am]
 BILLING CODE 6560-50-P


Comment Info: =================

General Comment:Dear Mr. Zeller:

I am writing as an individual consumer to request an extension of the comment period for the Food and Drug Administration's ("FDA") Proposed Rule Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking and Prevention and Tobacco Control Act (the "Proposed Rule") published at 79 Fed. Reg. 23,142 and Federal Register No. 2014-09491. On behalf of myself, I am requesting that the comment period for the Proposed Rule be extended by the FDA from its current 75-day period, to 180 days.

The Proposed Rule raises a number of significant issues and questions that are important and relevant to me, as a consumer of products that are proposed for regulation under the Proposed Rule. The Proposed Rule asks for feedback for many different issues. I want to provide my thoughts and comments on many of these issues, but my time to devote to researching and providing comments on these important questions is limited. I have already spent many hours researching and dissecting these issues, but they take time. I know that the FDA took many years to even come up with the Proposed Rule, so I do not think it is at all unreasonable to allow the public a mere six months to comment on it. This is our only opportunity, as consumers, to provide our feedback.

I feel very strongly about e-cigarettes as an alternative to combustible cigarettes. I truly believe that they have improved my health since switching from combustible cigarettes. I wish to provide you with my personal story, as well as science- and evidence-based responses to your questions so that you can take my comment into account. I realize that the FDA has the authority under 21 CFR 10.40 to extend this time frame and that the FDA has exercised this authority on numerous occasions in the past. I would therefore ask that you do so here, so that all stakeholders have the opportunity to provide their comments on this proposed regulation.

I appreciate your consideration of my request and am happy to discuss this issue with you further.