[Federal Register Volume 86, Number 145 (Monday, August 2, 2021)]
[Rules and Regulations]
[Pages 41406-41407]
[FR Doc No: 2021-16218]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R07-OAR-2021-0334; FRL-8706-02-R7]

Air Plan Approval; Missouri; Restriction of Emissions From
Lithographic and Letterpress Printing Operations

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is taking final
action to approve a State Implementation Plan (SIP) revision submitted
by the State of Missouri on November 10, 2020. This final action will
amend the SIP to revise a Missouri regulation which restricts volatile
organic compound emissions from lithographic and letterpress printing
operations in the St. Louis Metropolitan Area. Specifically, the State
has revised this rule in order to clarify rule applicability, update
incorporation by reference information, update test method references,
clarify definitions, and remove unnecessary words to improve clarity.
Approval of these revisions will ensure consistency between State and
federally-approved rules.

DATES: This final rule is effective on September 1, 2021.

ADDRESSES: The EPA has established a docket for this action under
Docket ID No. EPA-R07-OAR-2021-0334. All documents in the docket are
listed on the https://www.regulations.gov website. Although listed in
the index, some information is not publicly available, i.e.,
confidential business information (CBI) or other information whose
disclosure is restricted by statute. Certain other material, such as
copyrighted material, is not placed on the internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available through https://www.regulations.gov or please
contact the person identified in the FOR FURTHER INFORMATION CONTACT
section for additional information.

FOR FURTHER INFORMATION CONTACT: Larry Gonzalez, Environmental
Protection Agency, Region 7 Office, Air Quality Planning Branch, 11201
Renner Boulevard, Lenexa, Kansas 66219; telephone number: (913) 551-
7041; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document ``we,'' ``us,'' and
``our'' refer to EPA.

Table of Contents

I. What is being addressed in this document?
II. Have the requirements for approval of a SIP revision been met?
III. What action is the EPA taking?
IV. Incorporation by Reference
V. Statutory and Executive Order Reviews

I. What is being addressed in this document?

    The EPA is approving revisions to the Missouri SIP received on
November 10, 2020. The revisions are to Title 10, Division 10 of the
Code of State Regulations, 10 CSR 10-5.442 ``Control of Emissions From
Lithographic and Letterpress Printing Operations'', which establishes
emission limits for volatile organic compounds (VOCs) from lithographic
and letterpress printing operations in St. Louis City and Jefferson,
Franklin St. Louis, and St. Charles Counties (hereinafter referred to
in this document as the ``St. Louis Area''). The provision at 10 CSR
10-5.442 is SIP approved in the Code of Federal Regulations at 40 CFR
52.1320(c).
    These revisions, as discussed in section IV of the EPA's proposed
rule, and the technical support document (TSD) in the docket for the
proposed rule, are largely administrative in nature and do not have a
negative impact on air quality (86 FR 27543, May 21, 2021).
    The public comment period on the EPA's proposed rule opened May 21,
2021, the date of its publication in the Federal Register and closed on
June 21, 2021. During this period, the EPA received no comments. The
EPA is finalizing approval the revisions to this rule because it meets
the requirements of the Clean Air Act and will not have a negative
impact on air quality.

II. Have the requirements for approval of a SIP revision been met?

    The State's submission has met the public notice requirements for
SIP submissions in accordance with 40 CFR 51.102. The submission also
satisfied the completeness criteria of 40 CFR part 51, appendix V. The
State provided public notice of the revisions from May 1, 2019, to
August 1, 2019, and held a public hearing on July 25, 2019. The State
received and addressed five comments (four being from the EPA). As
explained in more detail in the TSD which is part of this docket, the
SIP revision submission meets the substantive requirements of the Clean
Air Act (CAA), including section 110 and implementing regulations.

III. What action is the EPA taking?

    The EPA is taking final action to amend the Missouri SIP by
approving the State's request to revise 10 CSR 10-5.442, ``Control of
Emissions From Lithographic and Letterpress Printing Operations.''
Approval of these revisions will ensure consistency between State and
federally-approved rules. The EPA has determined that these changes
meet the requirements of the Clean Air Act and will not have a negative
impact to air quality.

IV. Incorporation by Reference

    In this document, the EPA is finalizing regulatory text that
includes incorporation by reference. In accordance with the
requirements of 1 CFR 51.5, the EPA is finalizing the incorporation by
reference of the Missouri Regulations described in the amendments to 40
CFR part 52 set forth below. The EPA has made, and will continue to
make, these materials generally available through www.regulations.gov
and at the EPA Region 7 Office (please contact the person identified in
the FOR FURTHER INFORMATION CONTACT section of this preamble for more
information).
    Therefore, these materials have been approved by the EPA for
inclusion in the State Implementation Plan, have been incorporated by
reference by EPA into that plan, are fully federally enforceable under
sections 110 and 113 of the CAA as of the effective date of the final
rulemaking of the EPA's approval, and will be incorporated by reference
in the next update to the SIP compilation.\1\
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    \1\ 62 FR 27968, May 22, 1997.
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V. Statutory and Executive Order Reviews

    Under the Clean Air Act (CAA), the Administrator is required to
approve a SIP submission that complies with the provisions of the Act
and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, EPA's role is to approve state
choices, provided that they meet the criteria of the CAA. Accordingly,
this action merely approves state law as meeting Federal requirements
and does not impose additional requirements

beyond those imposed by state law. For that reason, this action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of the National Technology
Transfer and Advancement Act (NTTA) because this rulemaking does not
involve technical standards; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where the EPA or an Indian tribe
has demonstrated that a tribe has jurisdiction. In those areas of
Indian country, the rule does not have tribal implications and will not
impose substantial direct costs on tribal governments or preempt tribal
law as specified by Executive Order 13175 (65 FR 67249, November 9,
2000).
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by October 1, 2021. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and shall not postpone the effectiveness of such rule or
action. This action may not be challenged later in proceedings to
enforce its requirements (see section 307(b)(2)).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Volatile organic compounds.

    Dated: July 22, 2021.
Edward H. Chu,
Acting Regional Administrator, Region 7.

    For the reasons stated in the preamble, EPA amends 40 CFR part 52
as set forth below:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

    Authority:  42 U.S.C. 7401 et seq.

Subpart AA--Missouri

0
2. In Sec.  52.1320, the table in paragraph (c) is amended by revising
entry ``10-5.442'' to read as follows:

Sec.  52.1320  Identification of plan.

* * * * *
    (c) * * *

                                        EPA-Approved Missouri Regulations
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                                                        State
     Missouri citation                Title           effective      EPA approval date          Explanation
                                                         date
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                                    Missouri Department of Natural Resources
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                                                  * * * * * * *
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   Chapter 5--Air Quality Standards and Air Pollution Control Regulations for the St. Louis Metropolitan Area
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                                                  * * * * * * *
10-5.442...................  Control of Emissions     01/30/2020  8/2/2021, [insert       ......................
                              from Lithographic and                Federal Register
                              Letterpress Printing                 citation].
                              Operations.

                                                  * * * * * * *
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* * * * *
[FR Doc. 2021-16218 Filed 7-30-21; 8:45 am]
BILLING CODE 6560-50-P


Did not mail Pb designation letter to IA Governor.  IA submitted their
designation recommendations before EPA sent the letters to the
Governors.  We discussed with IDNR, and resolved to not send the letter
to IA’s governor, but instead emailed Jim McGraw of IDNR the Harnett
memo and timeline attachment, on 9/25/09.

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

Hello,

As discussed on the Sept 22 call, EPA received Iowa's Pb NAAQS
designation recommendation on Sept 17, 2009.  Since we have already
received your recommendation, we will not be sending a Pb NAAQS
designations process letter to the Governor.  Instead, as agreed to on
the call, we are emailing you the guidance memo from Bill Harnett.  It
contains additional information regarding future Pb NAAQS actions and
timelines.


[Federal Register Volume 81, Number 8 (Wednesday, January 13, 2016)]
[Rules and Regulations]
[Pages 1502-1504]
[FR Doc No: 2015-33170]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2015-4213; Directorate Identifier 2015-CE-022-AD;
Amendment 39-18359; AD 2016-01-01]
RIN 2120-AA64

Airworthiness Directives; Piper Aircraft, Inc. Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: We are adopting a new airworthiness directive (AD) for certain
Piper Aircraft, Inc. Model PA-46-500TP airplanes. This AD was prompted
by a report of the wing upper skin joints being manufactured without
sealant, which allows water to enter and stay in sealed, bonded
stringers. This AD requires inspecting the upper wing surface for
sealant; inspecting the wing stringers for water intrusion; inspecting
for deformation and corrosion if evidence of water intrusion exists;
and taking corrective actions as necessary. We are issuing this AD to
correct the unsafe condition on these products.

DATES: This AD is effective February 17, 2016.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of February 17,
2016.

ADDRESSES: For service information identified in this AD, contact Piper
Aircraft, Inc., Customer Service, 2926 Piper Drive, Vero Beach, Florida
32960; telephone:<PHONE_NUMBER>; fax: none; email:
<EMAIL_ADDRESS>Internet: www.piper.com. You may view this
referenced service information at the FAA, Small Airplane Directorate,
901 Locust, Kansas City, Missouri 64106. For information on the
availability of this material at the FAA, call<PHONE_NUMBER>. It is
also available on the Internet at http://www.regulations.gov by
searching for locating Docket No. FAA-2015-4213.

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-2015-
4213; 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 AD, the regulatory evaluation, any comments received, and
other information. The address for the Docket Office (telephone: 800-
647-5527) is Document Management Facility, U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Gregory ``Keith'' Noles, Aerospace
Engineer, FAA, Atlanta Aircraft Certification Office, 1701 Columbia
Avenue, College Park, Georgia 30337; telephone:<PHONE_NUMBER>; fax:
(404) 474-5606; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 by adding an AD that would apply to certain Piper Aircraft,
Inc. Model PA-46-500TP airplanes. The NPRM published in the Federal
Register on October 19, 2015 (80 FR 63151). The NPRM was prompted by a
report of wing upper skin joints on Piper Aircraft, Inc. Model PA-46-
500TP airplanes being manufactured without sealant, which allows water
to enter and stay in sealed, bonded stringers. The NPRM proposed to
require inspecting the upper wing surface for sealant; inspecting the
wing stringers for water intrusion; inspecting for deformation and
corrosion if evidence of water intrusion exists; and taking corrective
actions as necessary. We are issuing this AD to correct the unsafe
condition on these products.

Related Service Information Under 1 CFR Part 51

    We reviewed Piper Aircraft, Inc. Service Bulletin No. 1262B, dated
April 23, 2015. The service bulletin provides instructions for
inspecting the upper wing surface for sealant and sealing or resealing
(if necessary). This service bulletin also provides instructions for
inspecting the wing stringers for water intrusion, and, if water
intrusion was found as a result of the inspection, inspecting for
corrosion or deformation. 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 of this final rule.

Comments

    We gave the public the opportunity to participate in developing
this AD. We received no comments on the NPRM (80 FR 63151, October 19,
2015) or on the determination of the cost to the public.

Conclusion

    We reviewed the relevant data and determined that air safety and
the public interest require adopting this AD as proposed except for
minor editorial changes. We have determined that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM (80 FR 63151, October 19, 2015) for correcting the unsafe
condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM (80 FR 63151, October 19, 2015).

Costs of Compliance

    We estimate that this AD affects 440 airplanes of U.S. registry.
    We estimate the following costs to comply with this AD:

                                                 Estimated Costs
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                                                                                Cost per        Cost on U.S.
              Action                    Labor cost           Parts cost          product           operators
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Inspection for sealant...........  2 work-hours x $85   Not Applicable.....            $170             $74,800
                                    per hour = $170.
----------------------------------------------------------------------------------------------------------------

    We estimate the following costs to do any additional necessary
inspections, rework of the stringers, and installation of sealant that
will be required based on the results of the initial inspection. We
have no way of determining the number of airplanes that might need this
rework of the stringers and installation of sealant:

                                               On-Condition Costs
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                   Action                              Labor cost               Parts cost     Cost per product
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Rework stringers and seal skin joints......  12 work-hours x $85 per hour =            $200              $1,220
                                              $1,020.
----------------------------------------------------------------------------------------------------------------

    According to the manufacturer, some of the costs of this AD may be
covered under warranty, thereby reducing the cost impact on affected
individuals. We do not control warranty coverage for affected
individuals. As a result, we have included all costs in our cost
estimate.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    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

    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,
    (2) Is not a ``significant rule'' under 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.

Adoption of 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 (AD):

2016-01-01 Piper Aircraft, Inc.: Amendment 39-18359; Docket No. FAA-
2015-4213; Directorate Identifier 2015-CE-022-AD.

(a) Effective Date

    This AD is effective February 17, 2016.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Piper Aircraft, Inc. Model PA-46-500TP
airplanes, serial numbers 4697001 through 4697528, certificated in
any category.

(d) Subject

    Joint Aircraft System Component (JASC)/Air Transport Association
(ATA) of America Code 5700, Wings.

(e) Unsafe Condition

    This AD was prompted by a report of wing upper skin joints being
manufactured without sealant, which allows water to enter and stay
in sealed, bonded stringers. We are issuing this AD to prevent water
from entering the stringers common to the upper wing skin. Left
uncorrected, corrosion could develop, and freeze/thaw cycles of
water at this location could cause deformation of the skin with
follow-on disbonding between the stringer flanges and the inner
surface of the wing skin. Consequently, the corrosion or disbonding
could reduce the structural integrity of the wing.

(f) Compliance

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

(g) Inspect the Upper Skin Joints for Adequate Sealant

    Within the next 100 hours time-in-service (TIS) after February
17, 2016 (the effective date of this AD) or 12 months after February
17, 2016 (the effective date of this AD), whichever occurs first,
inspect the upper skin joints for adequate sealant following Part I
of Piper Aircraft, Inc. Service Bulletin No. 1262B, dated April 23,
2015. No further action per this AD is required if adequate sealant
is already applied.

(h) Inspect for Evidence of Water Intrusion/Moisture

    If you find missing or inadequate sealant during the inspection
required by paragraph (g) of this AD, before further flight, inspect
for evidence of water intrusion/moisture following Part II of Piper
Aircraft, Inc. Service Bulletin No. 1262B, dated April 23, 2015.
    (1) If no evidence of water intrusion/moisture is found during
the inspection required in paragraph (h) of this AD, before further
flight, rework the stringers and apply sealant as required in
paragraph (k) of this AD.
    (2) If evidence of water intrusion/moisture is found during the
inspection required in paragraph (h) of this AD, before further
flight, do the actions required in paragraphs (i) and (j) of this
AD.

(i) Inspect for Corrosion

    If you find, as a result of the inspection required by paragraph
(h) of this AD, evidence of water intrusion/moisture, before further
flight, inspect for corrosion following Part II of Piper Aircraft,
Inc. Service Bulletin No. 1262B, dated April 23, 2015.
    (1) If no evidence of corrosion is found during the inspection
required in paragraph (i) of this AD, before further flight, rework
the stringers and apply sealant as required in paragraph (k) of this
AD.
    (2) If evidence of corrosion is found during the inspection
required in paragraph (i) of this AD, before further flight, obtain
and implement an FAA-approved corrective action approved
specifically for this AD. At the operator's discretion, assistance
may be provided by contacting Piper Aircraft, Inc. at the address
identified in paragraph (p)(3) of this AD. After obtaining and
implementing an FAA-approved corrective action, approved
specifically for this AD, before further flight, rework the
stringers and apply sealant as required in paragraph (k) of this AD.

(j) Inspect for Deformation

    If you find, as a result of the inspection required by paragraph
(h) of this AD, evidence of water intrusion/moisture, before further
flight, do a visual inspection for skin or stringer deformation.
    (1) If no evidence of deformation is found during the inspection
required in paragraph (j) of this AD, before further flight, rework
the stringers and apply sealant as required in paragraph (k) of this
AD.
    (2) If any visible deformation is found during the inspection
required in paragraph (j) of this AD, before further flight, obtain
and implement an FAA-approved corrective action, approved
specifically for this AD. At the operator's discretion, assistance
may be provided by contacting Piper Aircraft, Inc. at the address
identified in paragraph (p)(3) of this AD. After obtaining and
implementing an FAA-approved corrective action, approved
specifically for this AD, before further flight, rework the
stringers and apply sealant as required in paragraph (k) of this AD.

(k) Rework Stringers and Seal Skin Joints

    If any inspection required by paragraphs (g) through (j) of this
AD reveals discrepancies (no sealant/inadequate sealant, evidence of
water intrusion/moisture, corrosion, or deformation), before further
flight, after completing any necessary corrective actions, rework
wing stringers and seal skin joints following Part II of Piper
Aircraft, Inc. Service Bulletin No. 1262B, dated April 23, 2015.

(l) Credit for Actions Done in Accordance With Previous Service
Information

    Actions done before February 17, 2016 (the effective date of
this AD) following Part I and Part II of Piper Aircraft, Inc.
Service Bulletin No. 1262, dated October 16, 2013, or Part I and
Part II of Piper Aircraft, Inc. Service Bulletin No. 1262A, dated
November 14, 2013, as applicable, are considered acceptable for
compliance with the corresponding actions specified in paragraphs
(g), (h), (i), and (k) (including subparagraphs) of this AD.
Additional inspections beyond Service Bulletin No. 1262 are required
to fully comply with paragraph (j) of this AD.

(m) Special Flight Permit

    (1) In accordance with 14 CFR 39.23, a single flight is allowed
to a location to do the actions in paragraph (g) of this AD.
    (2) In accordance with 14 CFR 39.23, a single flight is allowed
to a location to do the inspections, rework and installation of
sealant required in paragraphs (h) through (k) of this AD. Prior to
the flight to perform the inspections, rework, and installation of
sealant, the following inspection must be performed: If the
inspection required by paragraph (g) of this AD reveals no sealant,
inspect for evidence of wing damage (skin or stringer deformation,
e.g. buckling). Any wing damage that is found must be repaired
before further flight and before any special flight permit is
authorized.

(n) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Atlanta Aircraft Certification Office (ACO),
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 ACO, send it to the
attention of the person identified in paragraph (l)(1) of this AD.
    (2) 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

(o) Related Information

    For more information about this AD, contact Gregory ``Keith''
Noles, Aerospace Engineer, FAA, Atlanta ACO, 1701 Columbia Avenue,
College Park, Georgia 30337; telephone:<PHONE_NUMBER>; fax: (404)
474-5606; email<EMAIL_ADDRESS>
(p) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Piper Aircraft, Inc. Service Bulletin No. 1262B, dated April
23, 2015.
    (ii) Reserved.
    (3) For Piper Aircraft, Inc. service information identified in
this AD, contact Piper Aircraft, Inc., Customer Service, 2926 Piper
Drive, Vero Beach, Florida 32960; telephone:<PHONE_NUMBER>; fax:
None; email<EMAIL_ADDRESS>Internet: www.piper.com.
    (4) You may view this service information at FAA, Small Airplane
Directorate, 901 Locust, Kansas City, Missouri 64106. For
information on the availability of this material at the FAA, call
(816) 329-4148. It is also available on the Internet at http://www.regulations.gov by searching for locating Docket No. FAA-2015-
4213.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Kansas City, Missouri, on December 24, 2015.
Pat Mullen,
Acting Manager, Small Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2015-33170 Filed 1-12-16; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 80, Number 127 (Thursday, July 2, 2015)]
[Notices]
[Pages 38212-38216]
[FR Doc No: 2015-16360]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-2008]

Unapproved and Misbranded Otic Prescription Drug Products;
Enforcement Action Dates

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
its intention to take enforcement action against unapproved and
misbranded otic drug products labeled for prescription use and
containing benzocaine; benzocaine and antipyrine; benzocaine,
antipyrine, and zinc acetate; benzocaine, chloroxylenol, and
hydrocortisone; chloroxylenol and pramoxine; or chloroxylenol,
pramoxine, and hydrocortisone; and against persons who manufacture or
cause the manufacture or distribution of such products in interstate
commerce. These unapproved and misbranded prescription drug products
are marketed without evidence of safety and effectiveness; may present
safety concerns; and pose a direct challenge to the new drug approval
system and, in some cases, the over-the-counter (OTC) drug monograph
system.

DATES: This notice is effective July 2, 2015. For information about
enforcement dates, see SUPPLEMENTARY INFORMATION, section IV.

ADDRESSES: For all communications in response to this notice, identify
with Docket No. FDA-2015-N-2008 and direct to the appropriate office
listed in this ADDRESSES section as follows:
    Applications under section 505(b) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C. 355(b)): Division of Anesthesia,
Analgesia, and Addiction Products (for drug products with analgesic and
anti-inflammatory indications), or Division of Anti-Infective Drug
Products (for drug products with anti-infective indications), Office of
New Drugs, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 22, Silver Spring, MD
20993-0002.
    Applications under section 505(j) of the FD&C Act: Office of
Generic Drugs, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 75, Silver Spring, MD
20993-0002.
    All other communications about this action should be directed to:
Kathleen Joyce, Division of Prescription Drugs, Office of Unapproved
Drugs and Labeling Compliance, Center for Drug Evaluation and Research,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm.
5236, Silver Spring, MD 20993-0002;<PHONE_NUMBER> or email:
<EMAIL_ADDRESS>
FOR FURTHER INFORMATION CONTACT: Kathleen Joyce, Division of
Prescription Drugs, Office of Unapproved Drugs and Labeling Compliance,
Center for Drug Evaluation and Research, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 51, rm. 5236, Silver Spring, MD 20993-
0002;<PHONE_NUMBER> or email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing its intention to take enforcement action against
certain unapproved and misbranded otic drug products labeled for
prescription use. These marketed unapproved and misbranded otic drug
products are labeled for, among other things, the temporary relief of
pain associated with ear infections or inflammation, including acute
otitis media (middle ear infection), otitis media with effusion (fluid
in the ear, but without infection), and acute otitis externa (infection
in the outer ear or ``swimmer's ear''). Other indications for these
unapproved drug products include anti-infective and anti-inflammatory
claims, as well as claims for the removal of cerumen (earwax).
    This notice covers the following marketed unapproved prescription
otic drug products: (1) Single-ingredient otic drug products containing
benzocaine; (2) fixed-dose combination otic drug products containing
benzocaine and antipyrine; (3) fixed-dose combination otic drug
products containing benzocaine, antipyrine, and zinc

acetate; (4) fixed-dose combination otic drug products containing
benzocaine, chloroxylenol, and hydrocortisone; (5) fixed-dose
combination otic drug products containing chloroxylenol and pramoxine;
and (6) fixed-dose combination otic drug products containing
chloroxylenol, pramoxine, and hydrocortisone. These drug products are
marketed without evidence of safety and effectiveness, present safety
concerns, and pose a direct challenge to the new drug approval system
and, in some cases, the OTC drug monograph system.
    For example, FDA is aware of many unapproved and misbranded
prescription fixed-dose combination drug products containing benzocaine
and antipyrine that are labeled for use for the prompt relief of pain
and reduction of inflammation in the congestive and serous stages of
acute otitis media and for adjuvant therapy during systemic antibiotic
administration for resolution of acute otitis media. These products
have also been labeled to facilitate the removal of excessive or
impacted cerumen. FDA has received at least five adverse event reports
of allergic reactions to these drug products, including angioedema of
the ear, eye, face, neck, and/or mouth. We are also aware of at least
one case of methemoglobinemia associated with the administration of an
otic product containing benzocaine in an infant, which resulted in
death (Ref. 1). Methemoglobinemia is a serious blood disorder in which
an abnormal amount of methemoglobin (a form of hemoglobin) is produced
(Ref. 2). Other less serious adverse reactions associated with these
products include contact hypersensitivity, pruritus, stinging, burning,
and irritation.
    FDA is also aware of at least one unapproved and misbranded
prescription single-ingredient otic drug product containing benzocaine
that is labeled for use as a topical anesthetic in the external
auditory canal to relieve ear pain, and for the treatment of acute
otitis media, acute swimmer's ear, and other forms of otitis externa.
Potential adverse reactions include methemoglobinemia, local burning,
stinging, tenderness or edema, and hypersensitivity reactions.
    FDA is aware of an unapproved and misbranded prescription fixed-
dose combination drug product containing benzocaine, antipyrine, and
zinc acetate that is labeled with an indication to relieve pain,
congestion, and swelling caused by middle ear inflammation (acute
otitis media), and to help remove earwax. Potential adverse reactions
include methemoglobinemia and contact hypersensitivity, pruritus,
stinging, burning, and irritation.
    FDA is also aware of an unapproved and misbranded prescription
fixed-dose combination drug product containing benzocaine,
chloroxylenol, and hydrocortisone that is labeled for the treatment of
superficial infections of the external auditory canal complicated by
inflammation caused by organisms susceptible to the action of the
antimicrobial, and to control itching in the auditory canal. Unapproved
and misbranded prescription fixed-dose combination products containing
chloroxylenol and pramoxine are also on the market and labeled for
treating superficial external ear infections and the associated
itching. Potential adverse reactions for these fixed-dose combination
products include contact hypersensitivity, pruritus, stinging, burning,
and irritation.
    In addition, FDA is aware of various unapproved and misbranded
prescription fixed-dose combination drug products containing
chloroxylenol, pramoxine, and hydrocortisone that are labeled with
analgesic, anti-inflammatory and anti-infective indications. The
chloroxylenol, pramoxine, and hydrocortisone drug products are labeled
for the treatment of superficial infections of the outer ear,
inflammation, and itching. Potential adverse reactions include
pruritus, stinging, burning, and irritation.
    In addition to the safety concerns listed previously, these drugs
present direct challenges to the FDA drug approval system and, in some
cases, the OTC monograph system. These drugs directly challenge the new
drug approval system by competing with approved otic drug products
appropriately labeled for anti-inflammatory uses and the treatment of
otitis externa. The unapproved and misbranded drug products covered by
this notice also pose a direct challenge to the OTC drug monograph
system because they compete with legally marketed OTC products labeled
for cerumen removal and ear drying aid indications under an OTC drug
monograph (part 344 (21 CFR part 344)).
    For the reasons described in sections II and III, among others,
FDA's drug approval process is critical to protecting the public
health. Drugs are evaluated by FDA before being marketed to ensure that
they are safe and effective for their intended uses and are only
approved for marketing after a careful risk-benefit analysis. The drug
approval process is designed to avoid the risks associated with
potentially unsafe, ineffective, and fraudulent drugs.\1\
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    \1\ See ``Marketed Unapproved Drugs--Compliance Policy Guide''
(Marketed Unapproved Drugs CPG) at 5, available at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070290.pdf.
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II. Safety and Effectiveness Concerns With Unapproved New Drugs

    The new drug approval process affords FDA the opportunity to review
and evaluate a drug before it is marketed to ensure safety, efficacy,
and quality. This includes reviewing the processes used to manufacture
the active pharmaceutical ingredient(s) and the finished drug product,
and the labeling of the drug product. Because marketed unapproved new
drug products have not undergone FDA's rigorous premarket review and
approval process, they may present safety risks. This is particularly
true because FDA has not reviewed and approved the label for unapproved
new drugs, so some unapproved drug labeling omits or modifies safety
warnings or other information that is important to ensure safe use,
such as drug interactions or potential adverse experiences.
    With respect to the otic drug products subject to this notice, FDA
is particularly concerned about pediatric labeling because these drug
products are often prescribed for young children, a population most
susceptible to ear infections (Ref 3). FDA has not assessed the
scientific support, if any, for the use of these drug products in
pediatric populations. In other words, none of these products have been
shown to be safe for use in any population, including children or
infants. In fact, as described in section I, FDA has received at least
five adverse events reports associated with unapproved prescription
otic products. There is also the potential for rare, but serious
adverse events to occur, including methemoglobinemia, a dangerous blood
disorder. Not all of these adverse events are included in the labeling
for these unapproved drug products.
    FDA also has concerns regarding the manufacturing processes for
unapproved new drugs. When new drugs are marketed without FDA approval,
FDA does not have an opportunity, prior to product marketing, to
determine whether the manufacturing processes for the drugs are
adequate to ensure that they are of suitable quality.
    For example, the Agency scrutinizes the chemistry, manufacturing,
and controls involved in producing the active pharmaceutical ingredient
(API or drug substance) and finished dosage

form or drug product.\2\ With respect to the drug substance, FDA's
examination includes the following: (1) Physical and chemical
characteristics and stability of the drug substance; (2) the process
controls used in manufacturing and packaging; and (3) specifications
necessary to ensure the identity, strength, quality, and purity of the
drug substance. For the drug product, FDA's review includes the
following: (1) The specifications for the components used in the
manufacture of the drug product; (2) manufacturing and packaging
procedures and process controls; and (3) the specifications necessary
to ensure the identity, strength, quality, and purity of the drug
product. Unapproved drug products do not undergo this review process,
and therefore the quality of the finished drug product is uncertain.
---------------------------------------------------------------------------

    \2\ See, generally, Sec.  314.50(d) (21 CFR 314.50(d)). See also
section 505(d)(3) of the FD&C Act requiring FDA to determine whether
the methods used in, and the facilities and controls used for, the
manufacture, processing, and packing of such a drug are adequate to
preserve its identity, strength, quality, and purity.
---------------------------------------------------------------------------

    Because unapproved new drugs have not been subject to FDA's
premarket review and approval process, FDA cannot be sure that
unapproved drugs are effective. Section 505(d) of the FD&C Act requires
``substantial evidence'' of safety and effectiveness. ``Substantial
evidence'' is evidence consisting of adequate and well-controlled
investigations, including clinical investigations, by experts qualified
by scientific training and experience to evaluate the effectiveness of
the drug involved, on the basis of which it could fairly and
responsibly be concluded by such experts that the drug will have the
effect it purports or is represented to have under the conditions of
use prescribed, recommended, or suggested in the labeling or proposed
labeling thereof (section 505(d)(7) of the FD&C Act).
    Among other characteristics, an adequate and well-controlled study
must use a design that permits a valid comparison with a control to
provide a quantitative assessment of the pertinent drug effects (Sec.
314.126(b)(2)) (21 CFR 314.126(b)(2)). The method of selection of
subjects must assure that those subjects have the disease or condition
being studied (Sec.  314.126(b)(3)) .
    A review of the current literature suggests that the efficacy of
unapproved prescription otic drugs in managing pain associated with ear
infections is uncertain (Ref. 4). Use of unapproved products of
uncertain efficacy may delay treatment with products that have been
proven to be effective, leading to undue prolonged pain and discomfort.
    In conclusion, these drug products are marketed without evidence of
safety and effectiveness; present actual and potential safety concerns;
and pose a direct challenge to the new drug approval system. In some
cases, they may directly challenge the OTC drug monograph system.

III. Legal Status of Products Identified in This Notice

    FDA has reviewed the publicly available scientific literature for
the following unapproved prescription drug products: (1) Single-
ingredient otic drug products containing benzocaine; (2) fixed-dose
combination otic drug products containing benzocaine and antipyrine;
(3) fixed-dose combination otic drug products containing benzocaine,
antipyrine, and zinc acetate; (4) fixed-dose combination otic drug
products containing benzocaine, chloroxylenol, and hydrocortisone; (5)
fixed-dose combination otic drug products containing chloroxylenol and
pramoxine; and (6) fixed-dose combination otic drug products containing
chloroxylenol, pramoxine, and hydrocortisone. In no case did FDA find
literature sufficient to support a determination that any of these
prescription products are generally recognized as safe and effective.
Therefore, these prescription drug products are ``new drugs'' within
the meaning of section 201(p) of the FD&C Act (21 U.S.C. 321(p)), and
they require approved new drug applications (NDAs) or abbreviated new
drug applications (ANDAs) to be legally marketed.
    The unapproved drug products covered by this notice are labeled for
prescription use. Prescription drugs are defined under section
503(b)(1)(A) of the FD&C Act (21 U.S.C. 353(b)(1)(A)) as drugs that,
because of toxicity or other potentially harmful effect, are not safe
to use except under the supervision of a practitioner licensed by law
to administer such drugs. If an unapproved drug product covered by this
notice meets the definition of ``prescription drug'' in section
503(b)(1)(A) of the FD&C Act, adequate directions cannot be written for
it so that a layman can use the product safely for its intended uses
(21 CFR 201.5). Consequently, it is misbranded under section 502(f)(1)
of the FD&C Act (21 U.S.C. 352(f)(1)) in that it fails to bear adequate
directions for use. A prescription drug is exempt from the requirement
in section 502(f)(1) of the FD&C Act that it bear adequate directions
for use if, among other things, it bears the FDA-approved labeling (21
CFR 201.100(c)(2) and 201.115). Because the prescription drug products
subject to this notice do not have approved applications with approved
labeling, they fail to qualify for the exemptions to the requirement
that they bear ``adequate directions for use,'' and are misbranded
under section 502(f)(1) of the FD&C Act.
    If a drug covered by this notice is labeled as a prescription drug
but does not meet the definition of ``prescription drug'' under section
503(b)(1)(A) of the FD&C Act, the drug is misbranded under section
503(b)(4)(B).
    The final OTC drug monograph in part 344, ``Topical Otic Drug
Products for Over-the Counter Human Use'' (Topical Otic Drug
monograph), permits the use of carbamide peroxide 6.5 percent
formulated in an anhydrous glycerin vehicle as an active ingredient for
earwax removal, in the amounts and under the conditions specified in
the final Topical Otic Drug monograph (see Sec.  344.10). The final OTC
drug monograph also permits the use of isopropyl alcohol 95 percent in
an anhydrous glycerin 5 percent base as an ear drying aid in the
amounts and under the conditions specified in the final Topical Otic
Drug monograph (see Sec.  344.12).
    The final Topical Otic Drug monograph is the only monograph that
specifies the requirements for marketing an OTC drug for cerumen
removal. Unless a product included in this notice was reformulated and
labeled to meet all the requirements of the final Topical Otic Drug
monograph, the product would require an approved NDA or ANDA to be
legally marketed.\3\
---------------------------------------------------------------------------

    \3\ In addition to any other applicable requirements, firms that
manufacture OTC drugs must comply with the labeling requirements in
21 CFR 201.66.
---------------------------------------------------------------------------

IV. Notice of Intent To Take Enforcement Action

    Although not required to do so by the Administrative Procedure Act,
by the FD&C Act (or any rules issued under its authority), or for any
other legal reason, FDA is providing this notice to persons \4\ who are
marketing the following unapproved and misbranded drugs labeled for
prescription use: (1) Single-ingredient otic drug products containing
benzocaine; (2) fixed-dose combination otic drug products containing
benzocaine and antipyrine; (3) fixed-dose combination otic drug
products containing benzocaine, antipyrine, and zinc acetate; (4)
fixed-dose combination otic drug products containing benzocaine,
chloroxylenol, and

hydrocortisone; (5) fixed-dose combination otic drug products
containing chloroxylenol and pramoxine; and (6) fixed-dose combination
otic drug products containing chloroxylenol, pramoxine, and
hydrocortisone. The Agency intends to take enforcement action against
such products and those who manufacture them or cause them to be
manufactured or shipped in interstate commerce.
---------------------------------------------------------------------------

    \4\ The term ``person'' includes individuals, partnerships,
corporations, and associations (21 U.S.C. 321(e)).
---------------------------------------------------------------------------

    Manufacturing or shipping the drug products covered by this notice
can result in enforcement action, including seizure, injunction, or
other judicial or administrative proceeding.\5\ Consistent with
policies described in the Agency's Marketed Unapproved Drugs CPG
(available at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070290.pdf), the
Agency does not expect to issue a warning letter or any other further
warning to firms marketing drug products covered by this notice before
taking enforcement action. The Agency also reminds firms that, as
stated in the Marketed Unapproved Drugs CPG, any unapproved drug
marketed without a required approved application is subject to Agency
enforcement action at any time. The issuance of this notice does not in
any way obligate the Agency to issue similar notices (or any notice) in
the future regarding marketed unapproved drugs (see Marketed Unapproved
Drugs CPG at 5).
---------------------------------------------------------------------------

    \5\ In fact, U.S. Marshals seized $16.5 million of Auralgan Otic
Solution (which contains antipyrine and benzocaine) after Deston
continued to market the unapproved new drug following an FDA warning
letter. See http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm243638.htm.
---------------------------------------------------------------------------

    As described in the Marketed Unapproved Drugs CPG, the Agency may,
at its discretion, identify a period of time (i.e., a grace period)
during which the Agency does not intend to initiate an enforcement
action against a currently marketed unapproved drug solely on the
grounds that the drug lacks an approved application under section 505
of the FD&C Act. In deciding whether to allow such a grace period, the
Agency considers several factors, which are described in the Marketed
Unapproved Drugs CPG. With respect to drug products covered by this
notice, the Agency intends to exercise its enforcement discretion for
only a limited period of time, because there are readily available
legally marketed alternatives. Therefore, the Agency intends to
implement this notice as follows.
    For the effective date of this notice, see the DATES section of
this document. Any drug product covered by this notice that a company
(including a manufacturer or distributor) began marketing after
September 19, 2011, is subject to immediate enforcement action. For
products covered by this notice that a company (including a
manufacturer or distributor) began marketing on or before September 19,
2011, FDA intends to take enforcement action against any such product
that is not listed with the Agency in full compliance with section 510
of the FD&C Act (21 U.S.C. 360) before July 1, 2015, and is
manufactured, shipped, or otherwise introduced or delivered for
introduction into interstate commerce by any person on or after July 1,
2015. FDA also intends to take enforcement action against any drug
product covered by this notice that is listed with FDA in full
compliance with section 510 of the FD&C Act but is not being
commercially used or sold \6\ in the United States before July 1, 2015,
and that is manufactured, shipped, or otherwise introduced or delivered
for introduction into interstate commerce by any person on or after
July 2, 2015.
---------------------------------------------------------------------------

    \6\ For the purpose of this notice, the phrase ``commercially
used or sold'' means that the product has been used in a business or
activity involving retail or wholesale marketing and/or sale.
---------------------------------------------------------------------------

    However, for drug products covered by this notice that a company
(including a manufacturer or distributor): (1) Began marketing in the
United States on or before September 19, 2011; (2) are listed with FDA
in full compliance with section 510 of the FD&C Act before July 1, 2015
(``currently marketed and listed''); and (3) are manufactured, shipped,
or otherwise introduced or delivered for introduction into interstate
commerce by any person on or after July 2, 2015, the Agency intends to
exercise its enforcement discretion as follows: FDA intends to initiate
enforcement action regarding any such currently marketed and listed
product that is manufactured on or after August 17, 2015, or that is
shipped on or after September 30, 2015. Furthermore, FDA intends to
take enforcement action against any person who manufactures or ships
such products after these dates. The purpose of these enforcement
timeframes is to allow manufacturers and distributors to deplete their
current inventory and ensure a smooth transition for consumers. Any
person who has submitted or submits an application for a drug product
covered by this notice but has not received approval must comply with
this notice.
    The Agency, however, does not intend to exercise its enforcement
discretion as outlined previously if either of the following applies:
(1) A manufacturer or distributor of drug products covered by this
notice is violating other provisions of the FD&C Act, including, but
not limited to, violations related to FDA's current good manufacturing
practices, adverse drug event reporting, labeling, or misbranding
requirements other than those identified in this notice or (2) it
appears that a firm, in response to this notice, increases its
manufacture or interstate shipment of drug products covered by this
notice above its usual volume during these periods.\7\
---------------------------------------------------------------------------

    \7\ If FDA decides to take enforcement action against a product
covered by this notice, the Agency may simultaneously take action
relating to defendant's other violations of the FD&C Act. See, e.g.,
United States v. Sage Pharmaceuticals, 210 F. 3d 475, 479-480 (5th
Cir. 2000) (permitting the Agency to combine all violations of the
FD&C Act in one proceeding, rather than taking action against
multiple violations of the FD&C Act in ``piecemeal fashion'').
---------------------------------------------------------------------------

    Nothing in this notice, including FDA's intent to exercise its
enforcement discretion, alters any person's liability or obligations in
any other enforcement action, or precludes the Agency from initiating
or proceeding with enforcement action in connection with any other
alleged violation of the FD&C Act, whether or not related to a drug
product covered by this notice. Similarly, a person who is or becomes
enjoined from marketing unapproved or misbranded drugs may not resume
marketing of such products based on FDA's exercise of enforcement
discretion as described in this notice.
    Drug manufacturers and distributors should be aware that the Agency
is exercising its enforcement discretion as described previously only
in regard to drug products covered by this notice that are marketed
under a National Drug Code (NDC) number listed with the Agency in full
compliance with section 510 of the FD&C Act before July 1, 2015. As
previously stated, drug products covered by this notice that are
currently marketed but not listed with the Agency on the date of this
notice must, as of the effective date of this notice, have approved
applications before their shipment in interstate commerce. Moreover,
any person or firm that has submitted or submits an application but has
yet to receive approval for such products is still responsible for full
compliance with this notice.

V. Discontinued Products

    Some firms may have previously discontinued manufacturing or
distributing products covered by this notice without discontinuing the
listing as required under section 510(j) of the FD&C Act. Other firms
may discontinue

manufacturing or distributing listed products in response to this
notice. All firms are required to electronically update the listing of
their products under section 510(j) of the FD&C Act to reflect
discontinuation of unapproved products covered by this notice (21 CFR
207.21(b)). Questions on electronic drug listing updates should be sent
to<EMAIL_ADDRESS>In addition to the required update, firms can
also notify the Agency of product discontinuation by sending a letter,
signed by the firm's chief executive officer and fully identifying the
discontinued product(s), including the product NDC number(s), and
stating that the manufacturing and/or distribution of the product(s)
have been discontinued. The letter should be sent electronically to
Kathleen Joyce (see ADDRESSES). FDA plans to rely on its existing
records, including its drug listing records, the results of any
subsequent inspections, or other available information when considering
enforcement action.

VI. Reformulated Products

    FDA cautions firms against reformulating their products into
unapproved new drugs without benzocaine; benzocaine and antipyrine;
benzocaine, antipyrine, and zinc acetate; benzocaine, chloroxylenol,
and hydrocortisone; chloroxylenol and pramoxine; or chloroxylenol,
pramoxine, and hydrocortisone and marketing them under the same name or
substantially the same name (including a new name that contains the old
name) in anticipation of an enforcement action based on this notice. As
stated in the Marketed Unapproved Drugs CPG, FDA intends to give higher
priority to enforcement actions involving unapproved drugs that are
reformulated to evade an anticipated FDA enforcement action but have
not been brought into compliance with the law. In addition,
reformulated products marketed under a name previously identified with
a different active ingredient have the potential to confuse healthcare
practitioners and harm patients.

VIII. References

    The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday,
and are available electronically at http://www.regulations.gov.

1. Logan, B. K. and A.M. Gordon, ``Case Report: Death of an Infant
Involving Benzocaine,'' Journal of Forensic Sciences, vol. 50, pp.
1486-1488, 2005.
2. Cortazzo, J. A. and A. D. Lichtman, ``Methemoglobinemia: A Review
and Recommendations for Management.'' Journal of Cardiothoracic and
Vascular Anesthesia, vol. 28(4), pp. 1055-1059. 2014.
3. Lieberthal, A. S., A. E. Carroll, T. Chonmaitree, et al., ``The
Diagnosis and Management of Acute Otitis Media,'' Pediatrics, vol.
131, pp. e964-e999, 2013.
4. Wood, D. N., N. Naas, and C. W. Gregory, ``Clinical Trials
Assessing Ototopical Agents in the Treatment of Pain Associated with
Acute Otitis Media in Children,'' International Journal of
Otorhinolaryngology, vol. 76, pp. 1229-1335, 2012.

    Dated: June 26, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-16360 Filed 7-1-15; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 80, Number 55 (Monday, March 23, 2015)]
[Notices]
[Pages 15262-15264]
[FR Doc No: 2015-06515]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-74521; File No. SR-ISE-2014-43]

Self-Regulatory Organizations; International Securities Exchange,
LLC; Order Approving Proposed Rule Change, as Modified by Amendment No.
1, Amending its Information Barrier Rules

March 17, 2015.

I. Introduction

    On September 15, 2014, International Securities Exchange, LLC
(``Exchange'' or ``ISE'') filed with the Securities and Exchange
Commission (``Commission''), pursuant to Section 19(b)(1) of the
Securities Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4
thereunder,\2\ a proposed rule change amending its information barrier
rules. The proposed rule change was published for comment in the
Federal Register on October 6, 2014.\3\ The Commission received one
comment letter regarding the proposed rule change \4\ and one response
letter from ISE.\5\ On November 17, 2014, the Commission extended the
time period in which to either approve the proposed rule change,
disapprove the proposed rule change, or institute proceedings to
determine whether to approve or disapprove the proposed rule change to
January 2, 2015.\6\ On December 31, 2014, the Commission instituted
proceedings to determine whether to approve or disapprove the proposed
rule change.\7\ On March 9, 2015, the Exchange filed Amendment No. 1 to
the proposed rule change.\8\ This order approves the proposed rule
change, as modified by Amendment No. 1.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 73261 (September 30,
2014), 79 FR 60226 (``Notice'').
    \4\ See Letter from John Kinahan, Chief Executive Officer, Group
One Trading, L.P., dated October 27, 2014 (``Group One Letter'').
    \5\ See Letter from Michael J. Simon, Secretary and General
Counsel, International Securities Exchange, LLC, dated November 14,
2014 (``ISE Response Letter'').
    \6\ See Securities Exchange Act Release No. 73614 (November 17,
2014), 79 FR 69547 (November 21, 2014).
    \7\ See Securities Exchange Act Release No. 73973 (December 31,
2014), 80 FR 583 (January 6, 2015).
    \8\ In Amendment No. 1 the Exchange clarifies that an Electronic
Access Member (``EAM'') would only have access to the publicly
available orders and quotes of its affiliated market maker. In
addition, the Exchange clarifies that the proposed rule change would
not permit a member's EAM unit to access any non-public order or
quote information of its affiliated market maker, including any
hidden or undisplayed size or price information. The Exchange also
clarifies that market makers are not allowed to post hidden or
undisplayed orders and quotes on the Exchange. Finally, the Exchange
clarifies that its members would not expect to receive any
additional order or quote information as a result of this proposed
rule change. Amendment No. 1 is not subject to notice and comment
because it is a technical amendment that does not materially alter
the substance of the proposed rule change or raise any novel
regulatory issues.
    Amendment No. 1 has been placed in the public comment file for
SR-ISE-2014-43 at http://www.sec.gov/comments/sr-ise-2014-43/ise201443.shtml (see letter from Michael J. Simon, Secretary and
General Counsel, International Securities Exchange, LLC, to
Secretary, Commission, dated March 9, 2015) and also is available at
the Exchange's Web site at www.ise.com.
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II. Description of the Proposal

    The Exchange proposes to amend ISE Rules 810 (Limitations on
Dealings) and 717 (Limitations on Orders) governing information
barriers. Specifically, the Exchange proposes to amend Rule 810 to
permit information to flow to a member's EAM unit, which handles the
customer/agency side of the business, from its affiliated Primary
Market Maker (``PMM'') and/or Competitive Market Maker (``CMM'')
(jointly, ``market makers'') unit. As amended, ISE Rule 810 will allow
EAMs to know where, and at what price, their affiliated market makers
are either quoting or have orders on the order book \9\ and to use that
information to influence routing decisions. The Exchange represents
that it currently provides guidance to its members that ISE Rule 810 is
to be interpreted as a two-way information barrier between the EAM unit
and its affiliated market maker unit.\10\
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    \9\ According to ISE Rule 805(b)(1)(ii), market makers may only
have orders on the order book in option classes to which they are
not appointed.
    \10\ See Notice, supra note 3, 79 FR 60226, 60226.
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    The Exchange also proposes to amend ISE Rule 717, Supplementary
Material .06 to specify that the orders of a EAM

unit and its affiliated PMM and/or CMM unit may interact within one
second without violating the ISE Rule 717(d) and (e) order exposure
requirements when the firm can demonstrate that: (1) The customer order
was marketable when routed; (2) the EAM was not handling the affiliated
market maker quote/order; and (3) the affiliated market maker quote/
order was in existence at the time the customer order(s) were entered
into the ISE system. In combination, the proposed amendments to ISE
Rules 810 and 717 will make it possible for an EAM to route a customer
order to the ISE to immediately interact with the quote or an order of
an affiliated market maker, but only subject to the conditions stated
above.

III. Comment Letter and ISE's Response

    As noted above, the Commission received one comment letter \11\
opposing the proposed rule change.\12\ The commenter asserts that the
proposed one-way information barrier would introduce a conflict of
interest which could result in EAMs routing orders based on self-
interest as opposed to the customer's interest.\13\ The commenter
disagrees with the Exchange's premise that the proposed rule change
would not compromise market integrity or cause customer harm.\14\ The
commenter also indicates that although other exchanges may interpret
their rules to permit the sharing of information between the various
units of a firm, such sharing only weakens a customer's chance of best
execution.
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    \11\ See Group One Letter, supra note 5.
    \12\ See ISE Response Letter, supra note 6.
    \13\ See Group One Letter at 1, supra note 4.
    \14\ Id.
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    The commenter believes there are two specific scenarios where a
costumer may be harmed under this proposed rule change. First, the
commenter states that EAMs could route customer orders to an affiliated
market maker's quote at an exchange's best bid or offer rather than to
an exchange with a better fill rate or price improvement mechanism.\15\
Second, the commenter argues that an EAM holding a large customer order
that could influence the price in the underlying could opt to route
away from the quote of its affiliated market maker to avoid the
potential risk of the trade and deprive the customer of a fill they
were otherwise entitled to.\16\
---------------------------------------------------------------------------

    \15\ Id.
    \16\ Id. at 2.
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    The commenter indicates that these routing scenarios are not ``mere
conjecture'' as broker-dealers ``openly admit'' that numerous factors
are built into routing decisions that are primarily beneficial to
broker-dealers.\17\ The commenter also notes that there are litigation
and academic studies that suggest that routing decisions are negatively
impacted by conflicts of interest. The commenter believes that the
erosion of information barriers would increase the likelihood that
customer orders are routed based on the firm's best interest as opposed
to duty of best execution owed to the customer.\18\ The commenter
concludes that two-way information barriers are the ``only way to truly
guard customer interests and protect against the misuse of material
non-public information,'' and a shift to a one-way information barrier
would not provide any benefits EAM customers.\19\ The commenter also
believes that exchange rules should be written and interpreted in a way
that prevents conflicts of interest from ever arising, and a two-way
information barrier takes the potential conflict of interest out of the
equation.\20\
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    \17\ Id.
    \18\ Id.
    \19\ Id.
    \20\ Id.
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    The ISE responds that the commenter did not raise any new issues
and its concerns were addressed in the Notice.\21\ The ISE states that
nothing in the proposed rule change would relieve members of their best
execution obligation to obtain the most favorable terms reasonably
available for customer orders.\22\ The Exchange notes that, as a
national securities exchange, it has a comprehensive surveillance
program to monitor member compliance with applicable securities and
regulations, including best execution.\23\ ISE also represents that it
would continue to monitor for abnormalities in interaction rates
between members, and investigate and take appropriate regulatory action
against members that fail to comply with their best execution
obligations.\24\ ISE believes that its surveillance tools will allow it
to fulfill its regulatory responsibilities.\25\ ISE also suggests that
the filing is a competitive imperative as other options exchanges
currently interpret their information barrier rules to be one way
barriers that permit members to make routing decisions based on the
quotes and orders of affiliated business units.\26\
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    \21\ See ISE Response Letter at 1, supra note 6.
    \22\ Id.
    \23\ Id.
    \24\ Id.
    \25\ Id.
    \26\ Id. at 2.
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IV. Discussion and Commission Findings

    After careful consideration, the Commission finds that the proposed
rule change, as modified by Amendment No. 1, is consistent with the
requirements of the Act and the rules and regulations thereunder
applicable to a national securities exchange.\27\ The Commission
believes that the proposed rule change, as modified by Amendment No. 1,
is consistent with Section 6(b)(5) \28\ in particular, in that it is
designed to prevent fraudulent and manipulative acts and practices, to
promote just and equitable principles of trade, to foster cooperation
and coordination with persons engaged in facilitating transactions in
securities, to remove impediments to and perfect the mechanism of a
free and open market and a national market system, and, in general, to
protect investors and the public interest.
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    \27\ In approving this rule change, the Commission notes that it
has considered the proposed rule's impact on efficiency,
competition, and capital formation. See 15 U.S.C. 78c(f).
    \28\ 15 U.S.C. 78f(b)(5).
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    Amended ISE Rule 810 permits a less restrictive, one-way
information barrier between market makers and other business units, as
opposed to the prior rule that required a prescriptive, two-way
information barrier. Nonetheless, the Commission notes that Exchange
members are still required to have policies and procedures that are
reasonably designed to prevent the misuse of material, non-public
information consistent with Section 15(g) of the Act \29\ and ISE Rule
408.\30\ The Commission notes that the EAM unit of a member would not,
pursuant to the proposed rule change, have access to any non-public
quote or order information, including hidden or undisplayed price or
size information, of an affiliated market maker.\31\ The Commission
also notes that the Exchange has represented that its ongoing
surveillance for manipulative conduct and the Financial Industry
Regulatory Authority's exam program that reviews for member compliance
with such policies and procedures should provide a regulatory framework

that guards customer interests and protects against the misuse of
material non-public information.\32\
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    \29\ See 15 U.S.C. 78o(g). Section 15(g) of the Act requires
every broker or dealer to ``establish, maintain, and enforce written
policies and procedures reasonably designed, taking into
consideration the nature of such broker's or dealer's business, to
prevent the misuse. . .of material, nonpublic information by such
broker or dealer or any person associated with such broker or
dealer.''
    \30\ Further, Exchange members will continue to be subject to
ISE Rules 400 (Just and Equitable Principles of Trade), 401
(Adherence to Law), and 405 (Manipulation).
    \31\ See Amendment No. 1, supra note 8.
    \32\ See Notice, supra note 3, 79 FR 60226, 60227.
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    Finally, as noted above, the commenter expressed concern that this
proposed rule change would introduce a conflict of interest that would
erode the duty of best execution and harm customers. The Exchange
believes, and the Commission agrees, that this proposed rule change, as
modified by Amendment No. 1, does not alter a broker-dealer's duty of
best execution.\33\ Although the proposed rule change, as modified by
Amendment No. 1, will permit EAMs to know and consider the quotes of
its affiliated market makers when making routing decisions, the
Commission continues to expect that routing decisions related to the
duty of best execution will be premised solely on customer
considerations such as the likelihood of execution, the opportunity to
obtain price improvement, availability of best price and minimization
of market impact.\34\ The Commission emphasizes that a broker-dealer's
duty of best execution exists whether an EAM determines to route
customer order flow toward its affiliated market maker or away from its
affiliated market maker. Further, the Commission notes that in response
to the commenter's concern that the proposed rule change would
negatively impact best execution considerations, ISE stated that it
would ``continue to monitor for abnormalities in interaction rates
between members, and will investigate and take appropriate regulatory
action against members that fail to comply with their best execution
obligations . . . [and that] these surveillance tools will allow ISE to
comply with its regulatory responsibilities, consistent with treatment
across competitor options exchanges.'' \35\ Among other things, the
Commission's oversight of the ISE program is designed to evaluate the
ISE's performance in regard to that representation.
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    \33\ See Notice, supra note 3, 79 FR 60226, 60227; ISE Response
Letter at 1, supra note 6.
    \34\ See e.g., FINRA Rule 5310 (Best Execution and
Interpositioning); see also Securities Exchange Act Release No. 34-
51808, 70 FR 37496, 37537-8 (Jun. 29, 2005) (File No. S7-10-04)
(Regulation NMS Final Rules); Securities Exchange Act Release No.
37619A, 61 FR 48290, 48322-3 (Sep. 12, 1996) (File No. S7-30-95)
(Order Execution Obligations Final Rules).
    \35\ See ISE Response Letter at 1, supra note 6.
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V. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the Act
\36\ that the proposed rule change (SR-ISE-2014-43), as modified by
Amendment No. 1, be, and it hereby is, approved.
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    \36\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\37\
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    \37\ 17 CFR 200.30-3(a)(12).
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Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2015-06515 Filed 3-20-15; 8:45 am]
 BILLING CODE 8011-01-P