Appendix D

Summer 2009 Model-to-Monitor Results

This page intentionally left blank.

Figure D-1.  East tarmac – July 26, 2009 lead concentrations (ng/m3).

Figure D-2.  East tarmac – July 27, 2009 lead concentrations (ng/m3).

Figure D-3.  East tarmac – July 28, 2009 concentrations by source (ng/m3).

Figure D-4.  Residence 1 – July 26, 2009 lead concentrations (ng/m3).

Figure D-5.  Residence 1 – July 27, 2009 lead concentrations by source (ng/m3).

Figure D-6.  Residence 1 – July 28, 2009 lead concentrations (ng/m3).

Figure D-7.  Residence 2 – July 26, 2009 lead concentrations (ng/m3).

Figure D-8.  Residence 2 – July 27, 2009 lead concentrations (ng/m3).

Figure D-9.  Residence 2 – July 28, 2009 lead concentrations (ng/m3).

Figure D-10.  All sources – July 26–July 27, 2009.

Figure D-11.  All sources – July 27–July 28, 2009.

Figure D-12.  All sources – July 28–July 29, 2009.

  PAGE  ii

D-  PAGE  12


[Federal Register Volume 77, Number 96 (Thursday, May 17, 2012)]
[Notices]
[Page 29398]
[FR Doc No: 2012-12093]

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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meeting

    Notice is hereby given, pursuant to the provisions of the
Government in the Sunshine Act, Public Law 94-409, that the Securities
and Exchange Commission will hold a Closed Meeting on Tuesday, May 15,
2012 at 2:00 p.m.
    The General Counsel of the Commission, or his designee, has
certified that, in his opinion, one or more of the exemptions as set
forth in 5 U.S.C. 552b(c)(4) and (8) and 17 CFR 200.402(a)(4) and (8),
permit consideration of the scheduled matter at the Closed Meeting.
Certain staff members who have an interest in the matter also may be
present.
    Commissioner Gallagher, as duty officer, voted to consider the item
listed for the Closed Meeting in closed session, and determined that no
earlier notice thereof was possible.
    The subject matter of the May 15, 2012 Closed Meeting will be an
examination of a financial institution.
    At times, changes in Commission priorities require alterations in
the scheduling of meeting items. For further information and to
ascertain what, if any, matters have been added, deleted or postponed,
please contact the Office of the Secretary at<PHONE_NUMBER>.

    Dated: May 15, 2012.
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-12093 Filed 5-15-12; 4:15 pm]
BILLING CODE 8011-01-P


[Federal Register Volume 78, Number 112 (Tuesday, June 11, 2013)]
[Proposed Rules]
[Pages 34966-34969]
[FR Doc No: 2013-13828]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R05-OAR-2012-0891; FRL-9823-2]

Approval and Promulgation of Air Quality Implementation Plans;
Wisconsin; Removal of Gasoline Vapor Recovery From Southeast Wisconsin

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: EPA is proposing to approve a State Implementation Plan (SIP)
revision submitted by the Wisconsin Department of Natural Resources
(WDNR) on November 12, 2012, concerning the state's Stage II vapor
recovery (Stage II) program in southeast Wisconsin. The revision
removes Stage II requirements as a component of the Wisconsin ozone
SIP. The submittal also includes a demonstration under section 110(l)
of the Clean Air Act (CAA) that addresses emissions impacts associated
with the removal of the program.

DATES: Comments must be received on or before July 11, 2013.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R05-
OAR-2012-0891, by one of the following methods:
    1. www.regulations.gov: Follow the on-line instructions for
submitting comments.
    2. Email<EMAIL_ADDRESS>    3. Fax:<PHONE_NUMBER>.
    4. Mail: Pamela Blakley, Chief, Control Strategies Section, Air
Programs Branch (AR-18J), U.S. Environmental Protection Agency, 77 West
Jackson Boulevard, Chicago, Illinois 60604.
    5. Hand Delivery: Pamela Blakley, Chief, Control Strategies
Section, Air Programs Branch (AR-18J), U.S. Environmental Protection
Agency, 77 West Jackson Boulevard, Chicago, Illinois 60604. Such
deliveries are only accepted during the Regional Office normal hours of
operation, and special arrangements should be made for deliveries of
boxed information. The Regional Office official hours of business are
Monday through Friday, 8:30 a.m. to 4:30 p.m., excluding Federal
holidays.
    Instructions: Direct your comments to Docket ID No. EPA-R05-OAR-
2012-0891. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through www.regulations.gov or email. The
www.regulations.gov Web site is an ``anonymous access'' system, which
means EPA will not know your identity or contact information unless you
provide it in the body of your comment. If you send an email comment
directly to EPA without going through www.regulations.gov your email
address will be automatically captured and included as part of the
comment that is placed in the public docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses. For additional
instructions on submitting comments, go to section I of the
SUPPLEMENTARY INFORMATION section of this document.
    Docket: All documents in the docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in www.regulations.gov or in hard copy at the Environmental Protection
Agency, Region 5, Air and Radiation Division, 77 West Jackson
Boulevard, Chicago, Illinois 60604. This facility is open from 8:30
a.m. to 4:30 p.m., Monday through Friday, excluding Federal holidays.
We recommend that you telephone Francisco J. Acevedo, Environmental
Protection Specialist, at<PHONE_NUMBER> before visiting the Region 5
office.

FOR FURTHER INFORMATION CONTACT: Francisco J. Acevedo, Environmental
Protection Specialist, Control Strategies Section, Air Programs Branch
(AR-18J), Environmental Protection Agency, Region 5, 77 West Jackson
Boulevard, Chicago, Illinois 60604,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we,''
``us,'' or ``our'' is used, we mean

EPA. This supplementary information section is arranged as follows:

I. What should I consider as I prepare my comments for EPA?
II. Background
III. What changes have been made to the Wisconsin Stage II Vapor
Recovery Program?
IV. What is EPA's analysis of the state's submittal?
V. What action is EPA proposing to take?
VI. Statutory and Executive Order Reviews

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

    When submitting comments, remember to:
    1. Identify the rulemaking by docket number and other identifying
information (subject heading, Federal Register date, and page number).
    2. Follow directions--EPA may ask you to respond to specific
questions or organize comments by referencing a Code of Federal
Regulations (CFR) part or section number.
    3. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    4. Describe any assumptions and provide any technical information
and/or data that you used.
    5. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    6. Provide specific examples to illustrate your concerns, and
suggest alternatives.
    7. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    8. Make sure to submit your comments by the close of the comment
period.

II. Background

    Stage II programs were adopted by some states beginning in the
1980s to meet the ozone National Ambient Air Quality Standards (NAAQS).
Stage II and onboard refueling vapor recovery systems (ORVR) are two
types of emission control systems that capture fuel vapors from vehicle
gas tanks during refueling. Stage II systems are specifically installed
at gasoline dispensing facilities (GDF) and capture the refueling fuel
vapors at the gasoline pump nozzle. The system carries the vapors back
to the underground storage tank at the GDF to prevent the vapors from
escaping to the atmosphere. ORVR systems are carbon canisters installed
directly on automobiles to capture the fuel vapors evacuated from the
gasoline tank before they reach the nozzle. The fuel vapors captured in
the carbon canisters are then combusted in the engine when the
automobile is in operation.
    Stage II and vehicle ORVR were initially both required by the 1990
Amendments to the CAA under sections 182(b)(3) and 202(a)(6),
respectively. In some areas Stage II has been in place for over 25
years, but was not widely implemented by the states until the early to
mid-1990s as a result of the CAA requirements for moderate, serious,
severe, and extreme ozone nonattainment areas and for states in the
Northeast Ozone Transport Region (OTR) under CAA section 184(b)(2). CAA
section 202(a)(6) required EPA to promulgate regulations for ORVR for
light-duty vehicles (passenger cars). The EPA adopted these
requirements in 1994, at which point moderate ozone nonattainment areas
were no longer subject to the section 182(b)(3) Stage II requirement.
However, some moderate areas retained Stage II requirements to provide
a control method to comply with rate-of-progress emission reduction
targets. ORVR equipment has been phased in for new passenger vehicles
beginning with model year 1998, and starting in 2001 for light-duty
trucks and most heavy-duty gasoline-powered vehicles. ORVR equipment
has been installed on nearly all new gasoline-powered light-duty
vehicles, light-duty trucks and heavy-duty vehicles since 2006.
    During the phase-in of ORVR controls, Stage II has provided
volatile organic compound (VOC) reductions in ozone nonattainment areas
and certain attainment areas of the OTR. Congress recognized that ORVR
and Stage II would eventually become largely redundant technologies,
and provided authority to the EPA to allow states to remove Stage II
from their SIPs after EPA finds that ORVR is in widespread use.
Effective May 16, 2012, the date the final rule was published in the
Federal Register (77 FR 28772), EPA determined that ORVR is in
widespread nationwide use for control of gasoline emissions during
refueling of vehicles at GDFs. Currently, more than 75 percent of
gasoline refueling nationwide occurs with ORVR-equipped vehicles, so
Stage II programs have become largely redundant control systems and
Stage II systems achieve an ever declining emissions benefit as more
ORVR-equipped vehicles continue to enter the on-road motor vehicle
fleet.\1\ EPA also exercised its authority under CAA section 202(a)(6)
to waive certain Federal statutory requirements for Stage II gasoline
vapor recovery at GDFs. This decision exempts all new ozone
nonattainment areas classified serious or above from the requirement to
adopt Stage II control programs. Similarly, any state currently
implementing Stage II programs may submit SIP revisions that, once
approved by EPA, would allow for the phase out of Stage II control
systems.
---------------------------------------------------------------------------

    \1\ In areas where certain types of vacuum-assist Stage II
systems are used, the differences in operational design
characteristics between ORVR and some configurations of these Stage
II systems result in the reduction of overall control system
efficiency compared to what could have been achieved relative to the
individual control efficiencies of either ORVR or Stage II emissions
from the vehicle fuel tank.
---------------------------------------------------------------------------

III. What changes have been made to the Wisconsin Stage II Vapor
Recovery Program?

    Wisconsin originally submitted a SIP revision to EPA on November
18, 1992, to satisfy the requirement of section 182(b)(3) of the CAA.
The revision applied to the counties of Kenosha, Kewanee, Manitowoc,
Milwaukee, Ozaukee, Racine, Sheboygan, Washington and Waukesha and was
incorporated within the WDNR's 1993-94 ozone 15% Control Plan. EPA
fully approved Wisconsin's Stage II program on August 13, 1993 (53 FR
43080), including the program's legal authority and administrative
requirements found in Section 285.31 of the Wisconsin Statutes and
Chapter NR 420.045 of the Wisconsin Administrative Code.
    On November 12, 2012, WDNR submitted a SIP revision requesting the
removal of Stage II requirements under NR 420.045 of the Wisconsin
Administrative Code from the Wisconsin ozone SIP. To support the
removal of the Stage II requirements, the revision included copies of
2011 Wisconsin Act 196 enacted on April 2, 2012 authorizing the
termination of Stage II requirements in Wisconsin; a summary of
MOVES2010b modeling results and Wisconsin specific calculations based
on EPA guidance used to calculate program benefits and demonstrate
widespread use of ORVR in southeast Wisconsin; and a section 110(l)
demonstration that includes offset emission credits. WDNR held a public
hearing on the Wisconsin Stage II SIP revision on October 8, 2012, in
Waukesha, Wisconsin and allowed for written public comments until
October 12, 2012.

IV. What is EPA's analysis of the state's submittal?

    Revisions to SIP-approved control measures must meet the
requirements of CAA section 110(l) to be approved by EPA. Section
110(l) states: ``The Administrator shall not approve a revision of a
plan if the revision would interfere with any applicable requirement
concerning attainment and reasonable further progress (as defined in
section 171), or any other applicable requirement of this Act.''
    EPA interprets section 110(l) to apply to all requirements of the
CAA and to all areas of the country, whether attainment, nonattainment,
unclassifiable, or maintenance for one or more of the six criteria
pollutants. EPA also interprets section 110(l) to require a
demonstration addressing all criteria pollutants whose emissions and/or
ambient concentrations may change as a result of the SIP revision. In
the absence of an attainment demonstration, to demonstrate no
interference with any applicable NAAQS or requirement of the CAA under
section 110(l), EPA believes it is appropriate to allow states to
substitute equivalent emissions reductions to compensate for any change
to a SIP-approved program, as long as actual emissions in the air are
not increased. ``Equivalent'' emissions reductions mean reductions
which are equal to or greater than those reductions achieved by the
control measure approved in the SIP. To show that compensating
emissions reductions are equivalent, modeling or adequate justification
must be provided. The compensating, equivalent reductions must
represent actual, new emissions reductions achieved in a
contemporaneous time frame to the change of the existing SIP control
measure, in order to preserve the status quo level of emission in the
air. In addition to being contemporaneous, the equivalent emissions
reductions must also be permanent, enforceable, quantifiable, and
surplus to be approved into the SIP.
    The Wisconsin Stage II SIP revision includes a 110(l) demonstration
that uses equivalent emissions reductions to compensate for emission
reduction losses resulting from the removal of Stage II program
requirements before ORVR is in widespread use in southeast Wisconsin.
WDNR has calculated that by 2016, ORVR will be in widespread use in
southeast Wisconsin and the absence of the Wisconsin Stage II program
after 2016 would not result in a net VOC emissions increase compared to
the continued utilization of this emissions control technology. The
emission reduction losses resulting from removing Stage II before 2016
are transitional and relatively small since ORVR-equipped vehicles will
continue to phase into the fleet over the coming years.
    WDNR's calculation indicates a maximum potential loss of 0.02 to
0.70 tons per summer day (tpsd) from 2012 through 2015, were the
decommissioning of existing Stage II systems to occur completely during
a specified year. However, decommissioning is scheduled to occur over a
four-year period from 2012 through 2015. This extended period was taken
into consideration to account for the costs and timing associated with
replacement equipment and the decommissioning cost process. Table 1
below summarizes WDNR's emissions calculations of the yearly emission
reduction losses during the Stage II decommissioning period between
2012 and 2015 in tpsd and tons per year (tpy) and highlights the
emissions difference that needs to be addressed as part of the 110(l)
demonstration.

     Table 1--(VOC Emissions Offsets Needed in Southeast Wisconsin)
------------------------------------------------------------------------
                                         2012        2013        2015
------------------------------------------------------------------------
Maximum Potential Loss of VOC        0.67-0.70    0.40-0.42   0.021-0.02
 Emission Credits (tpsd).                                      2
Percent Stage II Throughput          20%          50%         90%
 Decommissioned.
Tons per Summer Day Lost VOC Credit  0.134-0.140  0.200-0.21  0.019-0.02
 (tpsd).                                           0           0
Tons per Year Lost VOC Credit (tpy)  42.9-44.8    64.0-67.2   6.1-6.4
------------------------------------------------------------------------

    The implementation of the Stage II program in southeast Wisconsin
has resulted in reductions of VOC emissions. VOC contributes to the
formation of ground-level ozone. Thus the potential increase in VOC
needs to be offset with equivalent (or greater) emissions reductions
from another control measure in order to demonstrate non-interference
with the 8-hour ozone NAAQS.
    On June 6, 2012, the WDNR submitted a SIP revision related to the
state's vehicle inspection and maintenance (I/M) program. As part of
that submittal, WDNR provided VOC and oxides of nitrogen
(NOX) emission credits to offset changes to the SIP approved
I/M program. These emission credits were from previously permitted
emissions sources located in southeast Wisconsin that have permanently
shutdown, and whose permits have been revoked. The expiration and
revocation of these sources' permits allows the state to use the
emission credits associated with them for other purposes under the SIP
and makes such credits permanent and enforceable. Table 2 outlines the
remaining equivalent VOC emissions credits that are available between
2012 and 2015 that can be used for Stage II.
---------------------------------------------------------------------------

    \2\ 2011 Wisconsin Act 196 enacted on April 2, 2012 authorized
the termination of Stage II requirements beginning May 16, 2012, the
date when EPA finalized a rule determining that ORVR was in
widespread use nationwide. Stage II decommissioning in southeast
Wisconsin is set to occur within a four year period between 2012 and
2015.
    \3\ Based on 4:1 NOX to VOC Ratio (i.e. 4 tons of
NOX = 1 ton of VOC)
    \4\ The VOC emissions shortfall was interpolated between 2013
and 2015 since the MOVES modeling was not done specifically for this
year.

            Table 2--Available VOC and NOX Emission Credits for the Stage II Vapor Recovery Program.
----------------------------------------------------------------------------------------------------------------
                                                                                Equivalent VOC
                            Year \2\                                VOC (tons)      NOX (tons)      (tons) \3\
----------------------------------------------------------------------------------------------------------------
2012............................................................           42.02           46.42           53.63
2013............................................................           86.07           97.17          110.36
2014 \4\........................................................          130.12          147.92          167.10
2015............................................................          174.18          198.66          223.85
----------------------------------------------------------------------------------------------------------------

    Table 3 below summarizes WDNR's Stage II emissions make-up
demonstration. The table specifically highlights the annual emissions
shortfall that will take place during the phase out of the Wisconsin
Stage II program between 2012 and 2015. In addition, the table outlines
the amount of equivalent VOC emission credits that are being used to
offset the shortfall using the VOC to NOX conversion
approach outlined in EPA's proposed approval of Wisconsin's June 6,
2012 SIP revision (see 78 FR 24373). Based on the use of permanent,
enforceable, contemporaneous, surplus emissions reductions achieved
through the shutdown of permitted emissions sources, EPA believes that
the removal of the Wisconsin Stage II program does not interfere with
southeast Wisconsin's ability to demonstrate compliance with the 8-hour
ozone NAAQS.

 Table 3--Make-Up of Stage II Vapor Recovery Program Emissions Shortfall
------------------------------------------------------------------------
                                  VOC
                               emissions   Available VOC    Difference
             Year              shortfall     emissions      (shortfall-
                                 (tons)    credit (tons)  credit) (tons)
------------------------------------------------------------------------
2012.........................  42.9-44.8           53.63           -8.83
2013.........................  64.0-67.2          110.36          -43.16
2014.........................  47.0-49.6          167.10         -117.50
2015.........................  6.1-6.4            223.85         -217.45
------------------------------------------------------------------------

    EPA also examined whether the removal of Stage II program
requirements in southeast Wisconsin will interfere with attainment of
other air quality standards. Southeast Wisconsin is designated
attainment for all standards other than ozone and particulate matter,
including sulfur dioxide and nitrogen dioxide. EPA has no reason to
believe that the removal of the Stage II program in southeast Wisconsin
will cause the area to become nonattainment for any of these
pollutants. In addition, EPA believes that removing the Stage II
program requirements in southeast Wisconsin will not interfere with the
area's ability to meet any other CAA requirement.
    Based on the above discussion and the state's section 110(l)
demonstration, EPA believes that removal of the Stage II program would
not interfere with attainment or maintenance of any of the NAAQS in
both the Milwaukee-Racine and Sheboygan County nonattainment areas and
would not interfere with any other applicable requirement of the CAA,
and thus, are approvable under CAA section 110(l).

V. What action is EPA proposing to take?

    EPA is proposing to approve the revision to the Wisconsin ozone SIP
submitted by WDNR on November 12, 2012, because we find that the
revision meets all applicable requirements and it would not interfere
with reasonable further progress or attainment of any of the national
ambient air quality standards.

VI. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the CAA 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 Order
12866 (58 FR 51735, October 4, 1993);
     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 Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; 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, this rule does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian country located in
the state, and EPA notes that it will not impose substantial direct
costs on tribal governments or preempt tribal law.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Intergovernmental
relations, Nitrogen oxides, Ozone, Volatile organic compounds.

    Dated: June 3, 2013.
Susan Hedman,
Regional Administrator, Region 5.
[FR Doc. 2013-13828 Filed 6-10-13; 8:45 am]
BILLING CODE 6560-50-P


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432-800	ESBIOL 90% CONCENTRATE	BAYER ENVIRONMENTAL SCIENCE	90
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432-841	DS 215 PROFESSEIONAL INSECTICIDE	BAYER ENVIRONMENTAL SCIENCE	.15
S-Bioallethrin

432-841	DS 215 PROFESSEIONAL INSECTICIDE	BAYER ENVIRONMENTAL SCIENCE	.02
Deltamethrin

432-848	DS 210 PROFESSIONAL INSECTICIDE	BAYER ENVIRONMENTAL SCIENCE	.02
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432-848	DS 210 PROFESSIONAL INSECTICIDE	BAYER ENVIRONMENTAL SCIENCE	.1
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498-192	CHAMPION SPRAYON FLYING & CRAWLING INSECT KILLER FORUMLA II
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2724-680	SPI DELTAMETHRIN AEROSOL INSECTICIDE	WELLMARK INTERNATIONAL	.05
S-Bioallethrin

6218-43	SUMMIT MISTOCIDE-B	SUMMIT CHEMICAL CO	.35	S-Bioallethrin

6218-43	SUMMIT MISTOCIDE-B	SUMMIT CHEMICAL CO	.7	Piperonyl butoxide

6218-43	SUMMIT MISTOCIDE-B	SUMMIT CHEMICAL CO	1.168	MGK 264

8848-72	BLACK JACK DS 205 INSECT KILLER	SAFEGUARD CHEMICAL CORP	.05
S-Bioallethrin

8848-72	BLACK JACK DS 205 INSECT KILLER	SAFEGUARD CHEMICAL CORP	.02
Deltamethrin

9688-255	CHEMSICO WASP & HORNET KILLER DS	CHEMSICO	.05	S-Bioallethrin

9688-255	CHEMSICO WASP & HORNET KILLER DS	CHEMSICO	.01	Deltamethrin

9688-256	CHEMSICO AEROSOL INSECTICIDE DS	CHEMSICO	.05	S-Bioallethrin

9688-256	CHEMSICO AEROSOL INSECTICIDE DS	CHEMSICO	.02	Deltamethrin

13283-29	MULTI-BUG II	RAINBOW TECHNOLOGY CORP	.02	Deltamethrin

13283-29	MULTI-BUG II	RAINBOW TECHNOLOGY CORP	.05	S-Bioallethrin

28293-332	UNICORN FLYING & CRAWLING INSECT KILLER IV	PHAETON CORPORATION
.15	S-Bioallethrin

28293-332	UNICORN FLYING & CRAWLING INSECT KILLER IV	PHAETON CORPORATION
.02	Deltamethrin

28293-334	UNICORN FLYING & CRAWLING INSECT KILLER V	PHAETON CORPORATION
.02	Deltamethrin

28293-334	UNICORN FLYING & CRAWLING INSECT KILLER V	PHAETON CORPORATION
.1	S-Bioallethrin

28293-336	UNICORN FLYING & CRAWLING INSECT KILLER III	PHAETON
CORPORATION	.05	S-Bioallethrin

28293-336	UNICORN FLYING & CRAWLING INSECT KILLER III	PHAETON
CORPORATION	.02	Deltamethrin

73049-92	YOUR BRAND SBP-1382/BIOALLETHRIN(.20%+.125%) AQUEOUS PRESS.
VALENT BIOSCIENCES CORPORATION	.125	S-Bioallethrin

73049-92	YOUR BRAND SBP-1382/BIOALLETHRIN(.20%+.125%) AQUEOUS PRESS.
VALENT BIOSCIENCES CORPORATION	.2	Resmethrin

73049-95	SBP-1382/BIOALLETHRIN INSECTICIDE CONCENTRATE 10%-6.25% FORM
VALENT BIOSCIENCES CORPORATION	10	Resmethrin

73049-95	SBP-1382/BIOALLETHRIN INSECTICIDE CONCENTRATE 10%-6.25% FORM
VALENT BIOSCIENCES CORPORATION	6.25	S-Bioallethrin

73049-103	SBP-1382/BIOALLETHRIN INSECTICIDE CONCENTRATE 8%-16% FORMULA
VALENT BIOSCIENCES CORPORATION	16	S-Bioallethrin

73049-103	SBP-1382/BIOALLETHRIN INSECTICIDE CONCENTRATE 8%-16% FORMULA
VALENT BIOSCIENCES CORPORATION	8	Resmethrin

73049-155	ESBIOL TECHNICAL	VALENT BIOSCIENCES CORPORATION	96.2
S-Bioallethrin

73049-177	DS 205 INSECTICIDE	VALENT BIOSCIENCES CORPORATION	.02
Deltamethrin

73049-177	DS 205 INSECTICIDE	VALENT BIOSCIENCES CORPORATION	.05
S-Bioallethrin

73049-178	ULTRATEC DS 215 INSECTICIDE	VALENT BIOSCIENCES CORPORATION	.15
S-Bioallethrin

73049-178	ULTRATEC DS 215 INSECTICIDE	VALENT BIOSCIENCES CORPORATION	.02
Deltamethrin

73049-180	DS 530 INSECTICIDE	VALENT BIOSCIENCES CORPORATION	.3
S-Bioallethrin

73049-180	DS 530 INSECTICIDE	VALENT BIOSCIENCES CORPORATION	.05
Deltamethrin

73049-183	ULTRATECH DS 210 INSECTICIDE	VALENT BIOSCIENCES CORPORATION
.02	Deltamethrin

73049-183	ULTRATECH DS 210 INSECTICIDE	VALENT BIOSCIENCES CORPORATION	.1
S-Bioallethrin

73049-184	ULTRATEC KD AC	VALENT BIOSCIENCES CORPORATION	2.86
S-Bioallethrin

73049-184	ULTRATEC KD AC	VALENT BIOSCIENCES CORPORATION	1.16
Deltamethrin

73049-210	DSP 0.25 - 2.5 - 25 AC	VALENT BIOSCIENCES CORPORATION	2.5
S-Bioallethrin

73049-210	DSP 0.25 - 2.5 - 25 AC	VALENT BIOSCIENCES CORPORATION	25
Piperonyl butoxide

73049-210	DSP 0.25 - 2.5 - 25 AC	VALENT BIOSCIENCES CORPORATION	.25
Deltamethrin

73049-354	ULTRATEC DS OB AC	VALENT BIOSCIENCES CORPORATION	.572
Deltamethrin

73049-354	ULTRATEC DS OB AC	VALENT BIOSCIENCES CORPORATION	2.86
S-Bioallethrin

73049-389	DSP 515 INSECTICIDE	VALENT BIOSCIENCES CORPORATION	.005
Deltamethrin

73049-389	DSP 515 INSECTICIDE	VALENT BIOSCIENCES CORPORATION	.5
Piperonyl butoxide

73049-389	DSP 515 INSECTICIDE	VALENT BIOSCIENCES CORPORATION	.1
S-Bioallethrin

73049-390	ULTRATEC DS 105 OB INSECTICIDE	VALENT BIOSCIENCES CORPORATION
.05	S-Bioallethrin

73049-390	ULTRATEC DS 105 OB INSECTICIDE	VALENT BIOSCIENCES CORPORATION
.01	Deltamethrin

73049-395	ESBIOL CONCENTRATE 90%	VALENT BIOSCIENCES CORPORATION	90
S-Bioallethrin

73049-459	ULTRA TEC DS YARD AND PATIO SPRAY	VALENT BIOSCIENCES
CORPORATION	.02	S-Bioallethrin

73049-459	ULTRA TEC DS YARD AND PATIO SPRAY	VALENT BIOSCIENCES
CORPORATION	.05	Deltamethrin

 PAGE

 PAGE   1


[Federal Register Volume 88, Number 104 (Wednesday, May 31, 2023)]
[Notices]
[Page 34881]
[FR Doc No: 2023-11525]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4697-DR; Docket ID FEMA-2023-0001]

Mississippi; Amendment No. 3 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Mississippi (FEMA-4697-DR), dated March 26, 2023, and
related determinations.

DATES: This amendment was issued April 19, 2023.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the State of Mississippi is hereby amended to include the following
area among those areas determined to have been adversely affected by
the event declared a major disaster by the President in his declaration
of March 26, 2023.
    Washington County for Public Assistance.

    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050 Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

Deanne Criswell,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2023-11525 Filed 5-30-23; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 87, Number 123 (Tuesday, June 28, 2022)]
[Rules and Regulations]
[Pages 38284-38286]
[FR Doc No: 2022-13539]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R01-OAR-2022-0113; FRL-9656-02-R1]

Air Plan Approval; State Implementation Plan Revisions Required
by the 2008 and 2015 Ozone Standards

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is approving State
Implementation Plan (SIP) revisions submitted by the State of
Connecticut for purposes of implementing the 2008 and 2015 ozone
National Ambient Air Quality Standards (NAAQS). The SIP revisions
consist of a demonstration that Connecticut meets the requirements of
reasonably available control technology (RACT) for the two precursors
for ground-level ozone, oxides of nitrogen (NOX) and
volatile organic compounds (VOCs), set forth by the Clean Air Act (CAA,
or the Act) with respect to the 2008 and 2015 ozone standards. We are
also approving a Consent Order that establishes NOX RACT
requirements for four facilities in the state. Additionally, we are
approving Connecticut's certification that it meets the nonattainment
new source review (NNSR) requirements of the CAA for purposes of the
2008 and 2015 ozone standards. This action is being taken in accordance
with the Clean Air Act.

DATES: This rule is effective on July 28, 2022.

ADDRESSES: EPA has established a docket for this action under Docket
Identification No. EPA-R01-OAR-2022-0113. 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., 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 at https://www.regulations.gov or at the U.S. Environmental Protection Agency, EPA
Region 1 Regional Office, Air and Radiation Division, 5 Post Office
Square--Suite 100, Boston, MA. EPA requests that if at all possible,
you contact the contact listed in the FOR FURTHER INFORMATION CONTACT
section to schedule your inspection. The Regional Office's official
hours of business are Monday through Friday, 8:30 a.m. to 4:30 p.m.,
excluding legal holidays and facility closures due to COVID-19.

FOR FURTHER INFORMATION CONTACT: Bob McConnell, Air Quality Branch,
U.S. Environmental Protection Agency, EPA New England Regional Office,
5 Post Office Square, Suite 100 (mail code 05-2), Boston, MA 02109-
3912, telephone number<PHONE_NUMBER>, email [email protected].

SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we,''
``us,'' or ``our'' is used, we mean EPA.

Table of Contents

I. Background and Purpose
II. Final Action
III. Incorporation by Reference
IV. Statutory and Executive Order Reviews

I. Background and Purpose

    On March 25, 2022, (87 FR 17052), EPA published a Notice of
Proposed Rulemaking (NPRM) for the State of Connecticut. The NPRM
proposed approval of a demonstration that Connecticut meets the
requirements of RACT for NOX and VOCs set forth by the CAA
with respect to the 2008 and 2015 ozone standards, and Consent Order
#8377 that establishes NOX RACT requirements for Middletown
Power LLC, Montville Power LLC, Connecticut Jet Power LLC, and Devon
Power LLC. We note that our March 25, 2022, proposal indicated that
these four facilities were owned and operated by NRG Connecticut.
However, the Connecticut Department of Energy and Environmental
Protection (CT DEEP) provided us with an administrative update to this
order to reflect that a new owner, Generation Bridge Acquisition LLC,
purchased the assets that are the subject of the order effective as of
November 1, 2021. Therefore, on May 5, 2022, CT DEEP submitted an
updated order, Consent Order #8377, Modification 1, and we are
approving that updated order into the state's SIP. Our March 25, 2022
proposal also proposed to approve negative declarations for a number of
source categories for which EPA has established Control Technique
Guidelines (CTGs). We note that Connecticut's December 21, 2020,
submittal included a negative declaration for EPA's 2016 Oil and Gas
CTG, which we approved separately on March 30, 2022 (see 87 FR 18274).
Additionally, our NPRM proposed approval of a certification that
Connecticut meets the NNSR requirements of the Act for purposes of the
2008 and 2015 ozone standards. The formal SIP revisions were submitted
by Connecticut on December 21, 2020. The specific requirements of these
SIP revisions and the rationale for EPA's proposed action are explained
in the NPRM and will not be restated here. No public comments were
received on the NPRM.

II. Final Action

    EPA is approving Connecticut's certification that it meets the
requirements of RACT for NOX and VOCs set forth by the CAA
with respect to the 2008 and 2015 ozone standards, Consent Order #8377,
Modification 1, that establishes NOX RACT requirements for
Middleton Power LLC, Montville Power LLC, Connecticut Jet Power LLC,
and Devon Power LLC, and a certification that Connecticut meets the
NNSR requirements of the Act for purposes of the 2008 and 2015 ozone
standards, as revisions to the Connecticut SIP.

III. Incorporation by Reference

    In this rule, the EPA is finalizing regulatory text that includes
incorporation by reference. In accordance with requirements of 1 CFR
51.5, the EPA is finalizing the incorporation by reference of State of
Connecticut, Department of Energy and Environmental Protection, Consent
Order #8377, Modification 1, issued to Middletown Power LLC, Montville
Power LLC, Connecticut Jet Power LLC, and Devon Power LLC, May 3, 2022.
The order establishes NOX RACT requirements for these
facilities for purposes of complying with Phase 2 of the Regulations of
Connecticut State

Agencies 22a-174-22e, Control of nitrogen oxide emissions from fuel
burning equipment at major stationary sources of nitrogen oxides. The
EPA has made, and will continue to make, these documents generally
available through https://www.regulations.gov and at the EPA Region 1
Office (please contact the person identified in the FOR FURTHER
INFORMATION CONTACT section of this preamble for more information).

IV. Statutory and Executive Order Reviews

    Under the Clean Air Act, 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 Clean Air Act.
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 Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; 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 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 Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by August 29, 2022. 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, Nitrogen dioxide, Ozone, Reporting and recordkeeping
requirements, Volatile organic compounds.

    Dated: June 18, 2022.
David Cash,
Regional Administrator, EPA Region 1.

    Part 52 of chapter I, title 40 of the Code of Federal Regulations
is amended as follows:

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 H--Connecticut

0
2. Section 52.370 is amended by adding paragraph (c)(128) to read as
follows:

Sec.  52.370  Identification of plan.

* * * * *
    (c) * * *
    (128) Revisions to the State Implementation Plan submitted by the
Connecticut Department of Environmental Protection on December 20, 2021
and amended on May 3, 2022.
    (i) Incorporation by reference. (A) State of Connecticut,
Department of Energy and Environmental Protection, Consent Order #
8377, Modification 1, issued to Middletown Power LLC, Montville Power
LLC, Connecticut Jet Power LLC, and Devon Power LLC, May 3, 2022.
    (B) [Reserved]
    (ii) [Reserved]

0
3. Section 52.375 is amended by adding paragraph (i) to read as
follows:

Sec.  52.375  Certification of no sources.

* * * * *
    (i) In its December 21, 2020, submittal to EPA pertaining to
reasonably available control technology requirements as a serious area
for the 2008 ozone standard and for the 2015 ozone standard as a state
containing a moderate nonattainment area and a marginal nonattainment
area that is part of the Ozone Transport Region, the State of
Connecticut certified to the satisfaction of EPA that no sources
located in the State are covered by the following Control Technique
Guidelines:
    (1) Automobile and Light-Duty Truck Assembly Coatings.
    (2) Control of VOC Emissions from Large Petroleum Dry Cleaners.
    (3) Fiberglass Boat Manufacturing Materials.
    (4) Control of VOC Equipment Leaks from Natural Gas/Gasoline
Processing Plants.
    (5) Control of Refinery Vacuum Producing Systems, Wastewater
Separators, and Process Unit Turnarounds.
    (6) Control of Volatile Organic Compound Leaks from Petroleum
Refinery Equipment.
    (7) Flatwood Paneling Coatings.
    (8) The Oil and Natural Gas Industry.

0
4. Section 52.377 is amended by adding paragraphs (u) and (v) to read
as follows:

Sec.  52.377  Control strategy: Ozone.

* * * * *
    (u) Approval--Revisions to the Connecticut State Implementation
Plan (SIP) submitted on December 21, 2020. The SIP revisions satisfy
the requirement to implement reasonably available control technology
(RACT) for sources of volatile organic compounds (VOC) and oxides of
nitrogen (NOX) as a serious nonattainment area for purposes
of the 2008 ozone standard, and also approves RACT for Connecticut for
the 2015 ozone standard as a state containing a moderate nonattainment
area and a marginal area that is located within the Ozone Transport
Region.
    (v) Approval--Submittal from the Connecticut Department of Energy
and Environmental Protection dated December 21, 2020, to address the
nonattainment new source review (NNSR) requirements as a serious
nonattainment area for the 2008 8-hour ozone standard for the Greater
Connecticut and the New York-N. New Jersey-Long Island, NY-NJ-CT ozone
nonattainment areas, and also approves NNSR for Connecticut for the
2015 ozone standard as a state containing a moderate and a marginal
nonattainment area and being located within the Ozone Transport Region
as it meets the requirements for both the state's marginal and moderate
classifications.

[FR Doc. 2022-13539 Filed 6-27-22; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 87, Number 108 (Monday, June 6, 2022)]
[Notices]
[Pages 34321-34325]
[FR Doc No: 2022-12013]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-95005; File No. SR-EMERALD-2022-21]

Self-Regulatory Organizations; MIAX Emerald, LLC; Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change To Amend
Its Fee Schedule

May 31, 2022.
    Pursuant to the provisions of Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice
is hereby given that on May 18, 2022, MIAX Emerald, LLC (``MIAX
Emerald'' or ``Exchange''), filed with the Securities and Exchange
Commission (``Commission'') a proposed rule change as described in
Items I, II, and III below, which Items have been prepared by the
Exchange. The Commission is publishing this notice to solicit comments
on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange is filing a proposal to amend the MIAX Emerald Fee
Schedule (the ``Fee Schedule'').
    The text of the proposed rule change is available on the Exchange's
website at http://www.miaxoptions.com/rule-filings/emerald, at MIAX's
principal office, and at the Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant aspects of such
statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange proposes to amend Section 1)a)i) of the Fee Schedule
to amend the Simple Maker (defined

below) rebates in all Tiers (defined below) for options transactions in
Penny Classes (defined below) for executed Priority Customer \3\ Origin
orders. The Exchange originally filed this proposal on April 28, 2022
(SR-EMERALD-2022-17). On May 10, 2022, the Exchange withdrew SR-
EMERALD-2022-17 and resubmitted this proposal (SR-EMERALD-2022-20). On
May 18, 2022, the Exchange withdrew SR-EMERALD-2022-20 and resubmitted
this proposal.
---------------------------------------------------------------------------

    \3\ ``Priority Customer'' means a person or entity that (i) is
not a broker or dealer in securities, and (ii) does not place more
than 390 orders in listed options per day on average during a
calendar month for its own beneficial account(s). See Exchange Rule
100, including Interpretation and Policy .01.
---------------------------------------------------------------------------

Background
    The Exchange currently assesses transaction rebates and fees to all
market participants, which are based upon a threshold tier structure
(``Tier''). Tiers are determined on a monthly basis and are based on
three alternative calculation methods, as defined in Section 1)a)ii) of
the Fee Schedule. The calculation method that results in the highest
Tier achieved by the Member \4\ shall apply to all Origin types by the
Member, except the Priority Customer Origin type. For the Priority
Customer Origin calculation, the Tier applied for a Member and its
Affiliates' \5\ is solely determined by calculation Method 3, as
defined in Section 1)a)ii) of the Fee Schedule, titled ``Total Priority
Customer, Maker sides volume, based on % of CTCV (`Method 3').'' The
monthly volume thresholds for each of the methods, associated with each
Tier, are calculated as the total monthly volume executed by the Member
in all options classes on MIAX Emerald in the relevant Origins and/or
applicable liquidity, not including Excluded Contracts,\6\ (as the
numerator) expressed as a percentage of (divided by) Customer Total
Consolidated Volume (``CTCV'') (as the denominator). CTCV is calculated
as the total national volume cleared at The Options Clearing
Corporation (``OCC'') in the Customer range in those classes listed on
MIAX Emerald for the month for which fees apply, excluding volume
cleared at the OCC in the Customer range executed during the period of
time in which the Exchange experiences an ``Exchange System
Disruption'' \7\ (solely in the option classes of the affected Matching
Engine).\8\ In addition, the per contract transaction rebates and fees
shall be applied retroactively to all eligible volume once the Tier has
been reached by the Member. Members that place resting liquidity, i.e.,
orders on the MIAX Emerald System, will be assessed the specified
``maker'' rebate or fee (each a ``Maker'') and Members that execute
against resting liquidity will be assessed the specified ``taker'' fee
or rebate (each a ``Taker'').\9\ Members are also assessed lower
transaction fees and smaller rebates for order executions in standard
option classes in the Penny Interval Program \10\ (``Penny Classes'')
than for order executions in standard option classes which are not in
the Penny Program (``non-Penny Classes''), for which Members will be
assessed a higher transaction fees and larger rebates.
---------------------------------------------------------------------------

    \4\ ``Member'' means an individual or organization approved to
exercise the trading rights associated with a Trading Permit.
Members are deemed ``members'' under the Exchange Act. See the
Definitions Section of the Fee Schedule and Exchange Rule 100.
    \5\ ``Affiliate'' means (i) an affiliate of a Member of at least
75% common ownership between the firms as reflected on each firm's
Form BD, Schedule A, or (ii) the Appointed Market Maker of an
Appointed EEM (or, conversely, the Appointed EEM of an Appointed
Market Maker). An ``Appointed Market Maker'' is a MIAX Emerald
Market Maker (who does not otherwise have a corporate affiliation
based upon common ownership with an EEM) that has been appointed by
an EEM and an ``Appointed EEM'' is an EEM (who does not otherwise
have a corporate affiliation based upon common ownership with a MIAX
Emerald Market Maker) that has been appointed by a MIAX Emerald
Market Maker, pursuant to the following process. A MIAX Emerald
Market Maker appoints an EEM and an EEM appoints a MIAX Emerald
Market Maker, for the purposes of the Fee Schedule, by each
completing and sending an executed Volume Aggregation Request Form
by email to [email protected] no later than 2 business days
prior to the first business day of the month in which the
designation is to become effective. Transmittal of a validly
completed and executed form to the Exchange along with the
Exchange's acknowledgement of the effective designation to each of
the Market Maker and EEM will be viewed as acceptance of the
appointment. The Exchange will only recognize one designation per
Member. A Member may make a designation not more than once every 12
months (from the date of its most recent designation), which
designation shall remain in effect unless or until the Exchange
receives written notice submitted 2 business days prior to the first
business day of the month from either Member indicating that the
appointment has been terminated. Designations will become operative
on the first business day of the effective month and may not be
terminated prior to the end of the month. Execution data and reports
will be provided to both parties. See the Definitions Section of the
Fee Schedule.
    \6\ The term ``Excluded Contracts'' means any contracts routed
to an away market for execution. See the Definitions Section of the
Fee Schedule.
    \7\ The term ``Exchange System Disruption'' means an outage of a
Matching Engine or collective Matching Engines for a period of two
consecutive hour or more, during trading hours. See the Definitions
Section of the Fee Schedule.
    \8\ A ``Matching Engine'' is a part of the MIAX Emerald
electronic system that processes options orders and trades on a
symbol-by-symbol basis. See the Definitions Section of the Fee
Schedule.
    \9\ For a Priority Customer complex order taking liquidity in
both a Penny Class and non-Penny Class against Origins other than
Priority Customer, the Priority Customer order will receive a rebate
based on the Tier achieved.
    \10\ See Securities Exchange Act Release No. 88993 (June 2,
2020), 85 FR 35145 (June 8, 2020) (SR-EMERALD-2020-05) (Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change To
Amend Exchange Rule 510, Minimum Price Variations and Minimum
Trading Increments, To Conform the Rule to Section 3.1 of the Plan
for the Purpose of Developing and Implementing Procedures Designed
To Facilitate the Listing and Trading of Standardized Options) (the
``Penny Program'').
---------------------------------------------------------------------------

Proposal
    First, the Exchange proposes to amend Section 1)a)i) of the Fee
Schedule to amend the Simple Maker rebates in Tiers 1, 2 and 3 for
options transactions in Penny Classes for executed Priority Customer
Origin orders. Currently, the Exchange provides a Simple Maker rebate
of ($0.43) per contract for options transactions in most Penny Classes
(excluding SPY, QQQ, and IWM) for executed Priority Customer Origin
orders in Tiers 1, 2 and 3 per the rate table. The Exchange also
provides a higher Simple Maker rebate of ($0.45) per contract for
options transactions in Penny Classes for SPY, QQQ and IWM, which is
noted by the symbol ``[dtri]'' following the tables of rebates and fees
in Section 1)a)i) of the Fee Schedule.
    The Exchange now proposes to amend symbol ``[dtri]'' to modify the
Simple Maker rebate for all options in Penny Classes for executed
Priority Customer Origin orders in Tiers 1, 2 and 3 depending on
whether the contra is an Affiliated Market Maker.\11\ In particular,
the Exchange proposes to provide a lower Simple Maker rebate of ($0.37)
per contract for options in all Penny Classes for executed Priority
Customer Origin orders in Tiers 1, 2 and 3 when the contra is an
Affiliated Market Maker. To show the difference in rebates depending on
whether the contra is an Affiliated Market Maker, the Exchange proposes
to amend the text in symbol ``[dtri]'' to now read as follows: ``The
Simple Maker rebate in SPY, QQQ and IWM is ($0.45) for Priority
Customer Origin in Tiers 1, 2 and 3 when the contra is not an
Affiliated Market Maker. The Simple Maker rebate in all Penny Classes
is ($0.37) for Priority Customer Origin in Tiers 1, 2 and 3 when the
contra is an Affiliated Market Maker.'' In summary, with the proposed
changes, Priority Customer Origin orders in Tiers 1, 2 and 3 will
receive (a) the current ($0.43) per contract rebate for most Penny
Classes (excluding SPY, QQQ, and IWM classes)

when the contra is not an Affiliated Market Maker; (b) will continue to
receive the current ($0.45) per contract rebate for SPY, QQQ, and IWM
classes when the contra is not an affiliated Market Maker; and (c) will
receive the ($0.37) per contract rebate in all Penny Classes when the
contra is an affiliated Market Maker.
---------------------------------------------------------------------------

    \11\ The term ``Market Maker'' refers to ``Lead Market Maker''
(``LMM''), ``Primary Lead Market Maker'' (``PLMM'') and ``Registered
Market Maker'' (``RMM''), collectively. See the Definitions Section
of the Fee Schedule and Exchange Rule 100.
---------------------------------------------------------------------------

    Next, the Exchange proposes to amend Section 1)a)i) of the Fee
Schedule to amend the Simple Maker rebate in Tier 4 for options
transactions in Penny Classes for executed Priority Customer Origin
orders. Currently, the Exchange provides a Simple Maker rebate of
($0.53) for executed Priority Customer Origin orders in Tier 4 in
options in Penny Classes if the contra is not an Affiliated Market
Maker. If the contra is an Affiliated Market Maker, the Exchange
provides a lower Simple Maker rebate of ($0.43) for executed Priority
Customer Origin orders in Tier 4 in options in Penny Classes.\12\ Both
the lower Simple Maker rebate of ($0.43) and the rate table rebate of
($0.53) depending on whether the contra is or is not an Affiliated
Market Maker for executed Priority Customer Origin orders in Tier 4 in
Penny Classes is denoted by the symbol ``[squ]'' following the table of
fees and rebates in Section 1)a)i) of the Fee Schedule.
---------------------------------------------------------------------------

    \12\ See Fee Schedule, Section 1)a)i), note ``[squ]''. See
Securities Exchange Act Release Nos. 94406 (March 14, 2022), 87 FR
15460 (March 18, 2022) (SR-EMERALD-2022-10) (lowering Simple Maker
rebate in Tier 4 for options transactions in Penny Classes for
executed Priority Customer orders when the contra is an Affiliated
Market Maker from ($0.49) to ($0.43) and 89927 (September 21, 2020),
85 FR 60498 (September 25, 2020) (SR-EMERALD-2020-07) (establishing
lower Priority Customer Tier 4 Simple Maker rebates in Penny Classes
when the contra is an Affiliated Market Maker).
---------------------------------------------------------------------------

    The Exchange now proposes to lower the Simple Maker rebate in Tier
4 for options transactions in Penny Classes for executed Priority
Customer orders when the contra is an Affiliated Market Maker.
Specifically, the Exchange proposes to lower the Simple Maker rebate
for executed Priority Customer orders in options in Penny Classes in
Tier 4 from ($0.43) to ($0.37) when the contra is an Affiliated Market
Maker. To be clear, executed Priority Customer Origin order in options
in Penny Classes in Tier 4 will continue to receive the current ($0.53)
per contract rebate when the contra is not an Affiliated Market Maker.
The proposed change would be reflected in current footnote ``[squ]''
for Penny Classes. Accordingly, the Exchange proposes to update
footnote ``[squ]'' to now read: ``This Maker rebate is for executed
Priority Customer Simple Orders when the contra is not an Affiliated
Market Maker. When the contra is an Affiliated Market Maker, this Maker
rebate for executed Priority Customer Simple Orders will be ($0.37).''
    The purpose of adjusting the specified Simple Maker rebate is for
business and competitive reasons. In order to attract order flow, the
Exchange initially set its Maker rebates and Taker fees so that they
were meaningfully higher/lower than other options exchanges that
operate comparable maker/taker pricing models.\13\ The Exchange now
believes that it is appropriate to further adjust these specified Maker
rebates so that they are more in line with other exchanges, but will
still remain highly competitive such that they should enable the
Exchange to continue to attract order flow and maintain market
share.\14\
---------------------------------------------------------------------------

    \13\ See Securities Exchange Act Release No. 85393 (March 21,
2019), 84 FR 11599 (March 27, 2019) (SR-EMERALD-2019-15).
    \14\ See Cboe BZX Options Exchange Fee Schedule, under
``Transaction Fees'' (providing Customer rebates for Penny Program
Securities ranging from $0.25 to $0.53); see also Nasdaq Stock
Market, Options 7, Pricing Schedule, Section 2 Nasdaq Options
Market--Fees and Rebates, note 2 (providing lower rates when the
Participant is both the buyer and seller).
---------------------------------------------------------------------------

Implementation
    The proposed changes are immediately effective.
2. Statutory Basis
    The Exchange believes that its proposal to amend its Fee Schedule
is consistent with Section 6(b) of the Act \15\ in general, and
furthers the objectives of Section 6(b)(4) of the Act,\16\ in that it
is an equitable allocation of reasonable dues, fees and other charges
among Exchange members and issuers and other persons using its
facilities, and 6(b)(5) of the Act,\17\ in that it is designed to
prevent fraudulent and manipulative acts and practices, promote just
and equitable principles of trade, foster cooperation and coordination
with persons engaged in facilitating transactions in securities, remove
impediments to and perfect the mechanisms of a free and open market and
a national market system and, in general, protect investors and the
public interest.
---------------------------------------------------------------------------

    \15\ 15 U.S.C. 78f(b).
    \16\ 15 U.S.C. 78f(b)(4).
    \17\ 15 U.S.C. 78f(b)(1) and (b)(5).
---------------------------------------------------------------------------

    The Commission has repeatedly expressed its preference for
competition over regulatory intervention in determining prices,
products, and services in the securities markets. In Regulation NMS,
the Commission highlighted the importance of market forces in
determining prices and SRO revenues and, also, recognized that current
regulation of the market system ``has been remarkably successful in
promoting market competition in its broader forms that are most
important to investors and listed companies.'' \18\
---------------------------------------------------------------------------

    \18\ See Securities Exchange Act Release No. 51808 (June 9,
2005), 70 FR 37496 (June 29, 2005).
---------------------------------------------------------------------------

    There are currently 16 registered options exchanges competing for
order flow. Based on publicly-available information, and excluding
index-based options, no single exchange has a market share of more than
approximately 13-14% of the equity options market.\19\ Therefore, no
exchange possesses significant pricing power. More specifically, as of
May 17, 2022, the Exchange had a market share of approximately 3.68% of
executed volume of multiply-listed equity options for the month of May
2022.\20\
---------------------------------------------------------------------------

    \19\ See ``The Market at a Glance,'' (last visited May 17,
2022), available at https://www.miaxoptions.com/.
    \20\ See id.
---------------------------------------------------------------------------

    The Exchange believes that the ever-shifting market share among the
exchanges from month to month demonstrates that market participants can
discontinue or reduce use of certain categories of products and
services, terminate an existing membership or determine to not become a
new member, and/or shift order flow, in response to transaction fee
changes. For example, on February 28, 2019, the Exchange's affiliate,
MIAX PEARL, LLC (``MIAX Pearl''), filed with the Commission a proposal
to increase Taker fees in certain Tiers for options transactions in
certain Penny classes for Priority Customers and decrease Maker rebates
in certain Tiers for options transactions in Penny classes for Priority
Customers (which fee was to be effective March 1, 2019).\21\ MIAX Pearl
experienced a decrease in total market share for the month of March
2019, after the proposal went into effect. Accordingly, the Exchange
believes that the MIAX Pearl March 1, 2019 fee change, to increase
certain transaction fees and decrease certain transaction rebates, may
have contributed to the decrease in MIAX Pearl's market share and, as
such, the Exchange believes competitive forces constrain the
Exchange's, and other options exchanges, ability to set transaction
fees and market participants can shift order flow based on fee changes
instituted by the exchanges.
---------------------------------------------------------------------------

    \21\ See Securities Exchange Act Release No. 85304 (March 13,
2019), 84 FR 10144 (March 19, 2019) (SR-PEARL-2019-07).
---------------------------------------------------------------------------

    The Exchange believes its proposal to amend the Simple Maker
rebates for options transactions in Penny Classes for Priority
Customers is reasonable,

equitable and not unfairly discriminatory because all similarly
situated market participants in the same Origin type are subject to the
same tiered Maker rebates and Taker fees. The Exchange believes it is
equitable and not unfairly discriminatory to reduce the Simple Maker
rebates for Priority Customer orders in Penny Classes when the contra
is an Affiliated Market Maker for business and competitive reasons
because the Exchange initially set its Simple Maker rebates for such
orders higher than certain other options exchanges that operate
comparable maker/taker pricing models.\22\ The Exchange now believes
that it is appropriate to further decrease the specified Simple Maker
rebates so that they are more in line with other exchanges, but will
remain highly competitive such that they should enable the Exchange to
continue to attract order flow and maintain market share.\23\
---------------------------------------------------------------------------

    \22\ See supra note 13.
    \23\ See supra note 14.
---------------------------------------------------------------------------

    The Exchange believes that it is equitable and not unfairly
discriminatory to continue to provide higher rebates for Priority
Customer orders (even with the proposed changes) than to orders from
origin types that are not Priority Customer. A Priority Customer is by
definition not a broker or dealer in securities, and does not place
more than 390 orders in listed options per day on average during a
calendar month for its own beneficial account(s).\24\ This limitation
does not apply to participants on the Exchange whose behavior is
substantially similar to that of market professionals, including orders
from Non-MIAX Emerald Market Makers, Firm Proprietary/Broker-Dealer
Origins, and Non-Priority Customers, who will generally submit a higher
number of orders (many of which do not result in executions) than
Priority Customers. Furthermore, the Exchange believes that even with
the proposed changes, the rebates for Priority Customers will continue
to encourage Members to send Priority Customer orders to the Exchange,
which benefits all Exchange participants by providing more trading
opportunities and tighter spreads.
---------------------------------------------------------------------------

    \24\ See supra note 3.
---------------------------------------------------------------------------

    The Exchange believes it is reasonable and equitable to reduce the
Simple Maker rebates for Priority Customer orders in Penny Classes when
the contra is an Affiliated Market Maker (versus when the contra is not
an Affiliated Market Maker) because the Exchange already offers certain
potential fee benefits to Members and their Affiliates from their
aggregated volume. For example, pursuant to Section 1)a)ii) of the Fee
Schedule, the Tier applied for a Member and its Affiliates' Priority
Customer Origin is solely determined by Method 3 (Priority Customer
Maker volume). However, the Market Maker Origin receives the highest
Tier based on any of the three application methods, including based on
Tier achieved by their Affiliated Priority Customer Maker order flow.
Thus, for example, if a Market Maker and its Affiliates naturally
achieved Tier 1 from Market Maker Volume, the Exchange will also look
at their Priority Customer order flow and if that Priority Customer
order flow achieved higher Tiers (i.e., Tier 4), the Market Maker and
its Affiliates will receive the benefit of the Tier 4 rates based on
their Priority Customer order flow. The Exchange also believes it is
equitable and not unfairly discriminatory to continue to provide
different rebates depending on whether the contra is or is not an
Affiliated Market Maker for executed Priority Customer Origin orders
because competing exchanges also provide different rates depending on
whether the executing buyer and seller are affiliated.\25\ Further, the
Exchange's affiliate, Miami International Securities Exchange, LLC
(``MIAX''), provides a similar pricing structure for certain complex
order transactions for MIAX Members and their Affiliates that aggregate
their order flow.\26\ Accordingly, the Exchange believes it is
reasonable, equitable, and not unfairly discriminatory to provide a
lower rebate for certain Priority Customer Origin orders when the
executing buyer and seller are the same Member or Affiliates.
---------------------------------------------------------------------------

    \25\ See, e.g., Nasdaq Stock Market, Options 7, Pricing
Schedule, Section 2 Nasdaq Options Market--Fees and Rebates, note 2
(providing lower rates when the Participant is both the buyer and
seller).
    \26\ See MIAX Fee Schedule, Section 1)a)iii), notes ``K'' and
``[ssquf]''.
---------------------------------------------------------------------------

    Furthermore, the proposed decrease to the Simple Maker rebates for
Priority Customers when the contra is an Affiliated Market Maker
promotes just and equitable principles of trade, fosters cooperation
and coordination with persons engaged in facilitating transactions in
securities, and protects investors and the public interest, because
even with the decrease, the Exchange's proposed Simple Maker rebates
for such orders still remain highly competitive with certain other
options exchanges offering comparable pricing models, and should enable
the Exchange to continue to attract order flow and maintain market
share.\27\ The Exchange believes that the amount of such rebates, with
the proposed decrease, will continue to encourage those market
participants to send Priority Customer orders to the Exchange.
---------------------------------------------------------------------------

    \27\ See supra note 14.
---------------------------------------------------------------------------

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule changes will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act.
Intra-Market Competition
    The Exchange believes that the proposed changes to the specified
Simple Maker rebates for the applicable market participants should
continue to encourage the provision of liquidity that enhances the
quality of the Exchange's market and increases the number of trading
opportunities on the Exchange for all participants who will be able to
compete for such opportunities. The proposed rule change should enable
the Exchange to continue to attract and compete for Priority Customer
order flow with other exchanges. The Exchange believes that even with
the proposed changes, the rebates for Priority Customers will continue
to encourage Members to send Priority Customer orders to the Exchange,
which benefits all Exchange participants by providing more trading
opportunities and tighter spreads. However, this competition does not
create an undue burden on competition but rather offers all market
participants the opportunity to receive the benefit of competitive
pricing.
    The Exchange believes that the pricing structure to provide
different rebates depending on whether the contra is or is not an
Affiliated Market Maker for executed Priority Customer Origin orders
will not impose any undue burden on intra-market competition because
the different rates apply equally to all Members that aggregate their
order flow on the Exchange. Further, this pricing structure is not new
or novel and has been in place at the Exchange, its affiliate, MIAX,
and competing exchanges for years.\28\
---------------------------------------------------------------------------

    \28\ See supra notes 12, 25 and 26.
---------------------------------------------------------------------------

Inter-Market Competition
    The Exchange operates in a highly competitive market in which
market participants can readily favor competing venues if they deem fee
levels at a particular venue to be excessive. There are currently 16
registered options exchanges competing for order flow.

Based on publicly-available information, and excluding index-based
options, no single exchange has a market share of more than
approximately 13-14% of the equity options market.\29\ Therefore, no
exchange possesses significant pricing power. More specifically, as of
May 17, 2022, the Exchange had a market share of approximately 3.68% of
executed volume of multiply-listed equity options for the month of May
2022.\30\ Therefore, no exchange possesses significant pricing power in
the execution of multiply-listed equity options order flow. In such an
environment, the Exchange must continually adjust its transaction and
non-transaction fees to remain competitive with other exchanges and to
attract order flow. The Exchange believes that the proposed rule
changes reflect this competitive environment because it modifies the
Exchange's rebates in a manner that will allow the Exchange to remain
competitive.
---------------------------------------------------------------------------

    \29\ See supra note 19.
    \30\ See id.
---------------------------------------------------------------------------

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    Written comments were neither solicited nor received.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Act,\31\ and Rule 19b-4(f)(2) \32\ thereunder.
At any time within 60 days of the filing of the proposed rule change,
the Commission summarily may temporarily suspend such rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors, or otherwise
in furtherance of the purposes of the Act. If the Commission takes such
action, the Commission shall institute proceedings to determine whether
the proposed rule should be approved or disapproved.
---------------------------------------------------------------------------

    \31\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \32\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
File Number SR-EMERALD-2022-21 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.

All submissions should refer to File Number SR-EMERALD-2022-21. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549 on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-EMERALD-2022-21, and should be submitted
on or before June 27, 2022.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\33\
---------------------------------------------------------------------------

    \33\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2022-12013 Filed 6-3-22; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 79, Number 237 (Wednesday, December 10, 2014)]
[Notices]
[Pages 73322-73323]
[FR Doc No: 2014-28888]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-1067]

Patient Counseling Information Section of Labeling for Human
Prescription Drug and Biological Products--Content and Format; Guidance
for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing the availability of a guidance for industry entitled
``Patient Counseling Information Section of Labeling for Human
Prescription Drug and Biological Products--Content and Format.'' The
recommendations in this guidance are intended to assist applicants in
developing the ``Patient Counseling Information'' section of labeling
and to help ensure that this section of labeling is clear, useful,
informative, and to the extent possible, consistent in content and
format. This guidance finalizes the draft guidance issued on September
18, 2013.

DATES: Submit either electronic or written comments on Agency guidances
at any time.

ADDRESSES: Submit written requests for single copies of this guidance
to the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993, or the Office
of Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Jonas Santiago, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6348, Silver Spring, MD 20993-0002, 301-
796-5346; or Stephen Ripley, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm. 7301, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Patient Counseling Information Section of Labeling for Human
Prescription Drug and Biological Products--Content and Format.'' This
guidance is intended to assist applicants in developing the Patient
Counseling Information section of labeling required under 21 CFR
201.57(c)(18). Recommendations include the following: (1) How to decide
what topics to include in the section, (2) how to present information
within the section, and (3) how to format and organize section
contents.
    This guidance is one of a series of guidances FDA is developing, or
has developed, to assist applicants with the content and format of
labeling for human prescription drug and biological products. In the
Federal Register of January 24, 2006 (71 FR 3922), FDA published a
final rule on labeling for human prescription drug and biological
products. The final rule and additional guidances can be accessed at
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/LawsActsandRules/ucm084159.htm. The labeling requirements and these
guidances are intended to make information in prescription drug
labeling easier for health care practitioners to access, read, and use.
    This guidance finalizes the draft guidance issued on September 18,
2013 (78 FR 57394). FDA reviewed all received comments carefully during
the finalization of the guidance. Other than clarifying edits, no
changes of significance were made to the final version of the guidance.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
Agency's

current thinking on the content and format of the Patient Counseling
Information section of labeling for human prescription drug and
biological products. It does not create or confer any rights for or on
any person and does not operate to bind FDA or the public. An
alternative approach may be used if such approach satisfies the
requirements of the applicable statutes and regulations.

II. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

III. The Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR 201.56 and 201.57 have been
approved under OMB control number 0910-0572.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or
http://www.regulations.gov.

    Dated: December 4, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-28888 Filed 12-9-14; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 77, Number 16 (Wednesday, January 25, 2012)]
[Notices]
[Pages 3765-3766]
[FR Doc No: 2012-1478]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Notice of FERC Staff Attendance at the Entergy Regional State
Committee Work Group and Stakeholder Meeting

    The Federal Energy Regulatory Commission hereby gives notice that
members of its staff may attend the meeting noted below. Their
attendance is part of the Commission's ongoing outreach efforts.

Entergy Regional State Committee Working Group and Stakeholders Meeting

    January 26, 2012 (9 a.m.-3 p.m.).
    This meeting will be held at the Pan American Life Center, 601
Poydras Street, New Orleans, LA 70130.
    The discussions may address matters at issue in the following
proceedings:

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

------------------------------------------------------------------------
Docket No. OA07-32.....................  Entergy Services, Inc.
Docket No. EL00-66.....................  Louisiana Public Service
                                          Commission v. Entergy
                                          Services, Inc.
Docket No. EL01-88.....................  Louisiana Public Service
                                          Commission v. Entergy
                                          Services, Inc.
Docket No. EL07-52.....................  Louisiana Public Service
                                          Commission v. Entergy
                                          Services, Inc.
Docket No. EL08-51.....................  Louisiana Public Service
                                          Commission v. Entergy
                                          Services, Inc.

Docket No. EL08-60.....................  Ameren Services Co. v. Entergy
                                          Services, Inc.
Docket No. EL09-43.....................  Arkansas Public Service
                                          Commission v. Entergy
                                          Services, Inc.
Docket No. EL09-50.....................  Louisiana Public Service
                                          Commission v. Entergy
                                          Services, Inc.
Docket No. EL09-61.....................  Louisiana Public Service
                                          Commission v. Entergy
                                          Services, Inc.
Docket No. EL10-55.....................  Louisiana Public Service
                                          Commission v. Entergy
                                          Services, Inc.
Docket No. EL10-65.....................  Louisiana Public Service
                                          Commission v. Entergy
                                          Services, Inc.
Docket No. EL11-34.....................  Midwest Independent System
                                          Transmission Operator, Inc.
Docket No. ER05-1065...................  Entergy Services, Inc.
Docket No. ER07-682....................  Entergy Services, Inc.
Docket No. ER07-956....................  Entergy Services, Inc.
Docket No. ER08-1056...................  Entergy Services, Inc.
Docket No. ER09-833....................  Entergy Services, Inc.
Docket No. ER09-1224...................  Entergy Services, Inc.
Docket No. ER10-794....................  Entergy Services, Inc.
Docket No. ER10-1350...................  Entergy Services, Inc.
Docket No. ER10-1676...................  Entergy Services, Inc.
Docket No. ER10-2001...................  Entergy Arkansas, Inc.
Docket No. ER10-3357...................  Entergy Arkansas, Inc.
Docket No. ER11-2131...................  Entergy Arkansas, Inc.
Docket No. ER11-2132...................  Entergy Gulf States, Louisiana,
                                          LLC
Docket No. ER11-2133...................  Entergy Gulf States, Louisiana,
                                          LLC
Docket No. ER11-2134...................  Entergy Mississippi, Inc.
Docket No. ER11-2135...................  Entergy New Orleans, Inc.
Docket No. ER11-2136...................  Entergy Texas, Inc.
Docket No. ER11-3156...................  Entergy Arkansas, Inc.
Docket No. ER11-3657...................  Entergy Arkansas, Inc.
Docket No. ER12-480....................  Midwest Independent
                                          Transmission System Operator,
                                          Inc.
------------------------------------------------------------------------

    These meetings are open to the public.
    For more information, contact Patrick Clarey, Office of Energy
Market Regulation, Federal Energy Regulatory Commission at (317) 249-
5937 or<EMAIL_ADDRESS>
    Dated: January 18, 2012.
Kimberly D. Bose,
Secretary.
[FR Doc. 2012-1478 Filed 1-24-12; 8:45 a.m.]
BILLING CODE 6717-01-P