[Federal Register Volume 83, Number 107 (Monday, June 4, 2018)]
[Notices]
[Page 25676]
[FR Doc No: 2018-11874]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4364-DR; Docket ID FEMA-2018-0001]

North Carolina; Amendment No. 1 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 North Carolina (FEMA-4364-DR), dated May 8, 2018, and
related determinations.

DATE: The amendment was issued on May 17, 2018.

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 Federal Emergency Management Agency
(FEMA) hereby gives notice that pursuant to the authority vested in the
Administrator, under Executive Order 12148, as amended, Glen
Sachtleben, of FEMA is appointed to act as the Federal Coordinating
Officer for this disaster.
    This action terminates the appointment of Elizabeth Turner as
Federal Coordinating Officer for this disaster.

    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.

Brock Long,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2018-11874 Filed 6-1-18; 8:45 am]
 BILLING CODE 9111-23-P


[Federal Register Volume 85, Number 136 (Wednesday, July 15, 2020)]
[Proposed Rules]
[Pages 42807-42808]
[FR Doc No: 2020-14577]

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 ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 62

[EPA-R03-OAR-2019-0527; FRL-10011-14-Region 3]

Approval and Promulgation of State Air Quality Plans for
Designated Facilities and Pollutants; State of Maryland; Control of
Emissions From Existing Sewage Sludge Incineration Units

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve the negative declaration submitted by the State of Maryland for
Sewage Sludge Incineration (SSI) units. This negative declaration
submitted by the Maryland Department of the Environment (MDE) certifies
that SSI units subject to sections 111(d) and 129 of the Clean Air Act
(CAA) do not exist within the jurisdiction of the State of Maryland.
This action is being taken under the CAA.

DATES: Written comments must be received on or before August 14, 2020.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R03-
OAR-2019-0527 at https://www.regulations.gov, or via email to
<EMAIL_ADDRESS>For comments submitted at Regulations.gov,
follow the online instructions for submitting comments. Once submitted,
comments cannot be edited or removed from Regulations.gov. For either
manner of submission, EPA may publish any comment received to its
public docket. Do not submit electronically any information you
consider to be confidential business information (CBI) or other
information whose disclosure is restricted by statute. Multimedia
submissions (audio, video, etc.) must be accompanied by a written
comment. The written comment is considered the official comment and
should include discussion of all points you wish to make. EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e., on the web, cloud, or other file sharing
system). For additional submission methods, please contact the person
identified in the FOR FURTHER INFORMATION CONTACT section. For the full
EPA public comment policy, information about CBI or multimedia
submissions, and general guidance on making effective comments, please
visit https://www.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Matthew Willson, Permits Branch
(3AD10), Air & Radiation Division, U.S. Environmental Protection
Agency, Region III, 1650 Arch Street, Philadelphia, Pennsylvania 19103.
The telephone number is<PHONE_NUMBER>. Mr. Willson can also be reached
via electronic mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    The CAA requires that state regulatory agencies implement emission
guidelines and associated compliance times using a state plan developed
under sections 111(d) and 129 of the CAA. The general provisions for
the submittal and approval of state plans are codified in 40 Code of
Federal Regulations (CFR) part 60, subpart B and 40 CFR part 62,
subpart A. Section 111(d) establishes general requirements and
procedures on state plan submittals for the control of designated
pollutants. Section 129 requires emission guidelines to be promulgated
for all categories of solid waste incineration units, including SSI
units. SSI units are defined at 40 CFR 60.5250 as ``an incineration
unit combusting sewage sludge for the purpose of reducing the volume of
the sewage sludge by removing combustible matter. Sewage sludge
incineration unit designs include fluidized bed and multiple hearth. A
SSI unit also includes, but is not limited to, the sewage sludge feed
system, auxiliary fuel feed system, grate system, flue gas system,
waste heat recovery equipment, if any, and bottom ash system. The SSI
unit includes all ash handling systems connected to the bottom ash
handling system. The combustion unit bottom ash system ends at the
truck loading station or similar equipment that transfers the ash to
final disposal. The SSI unit does not include air pollution control
equipment or the stack.''
    Section 129 mandates that all plan requirements be at least as
protective as the promulgated emission guidelines. This includes fixed
final compliance dates, fixed compliance schedules, and title V
permitting requirements for all affected sources. Section 129 also
requires that state plans be submitted to EPA within one year after
EPA's promulgation of the emission guidelines and compliance times.
    States have options other than submitting a state plan in order to
fulfill their obligations under CAA sections 111(d) and 129. If a state
does not have any existing SSI units for the relevant emission
guidelines, a letter can be submitted certifying that no such units
exist within the state (i.e., negative declaration) in lieu of a state
plan, in accordance with 40 CFR 60.5010. The negative declaration
exempts the state from the requirements of subpart B that would
otherwise require the submittal of a CAA section 111(d)/129 plan.
    On March 21, 2011 (76 FR 15372), EPA finalized emission guidelines
for SSI units at 40 CFR part 60, subpart MMMM. Following the 2011 final
rule, MDE determined that there was one SSI facility in Maryland that
met the applicability criteria for the Federal plan. On January 20,
2017, MDE submitted a letter to EPA requesting full delegation of
authority to implement the SSI Federal plan. However, that facility has
now permanently shut down and has relinquished its title V Permit to
operate. Accordingly, MDE sent a negative declaration for SSI units on
April 3, 2020.
    For additional background information on MDE's negative
declaration, see the documents that are available online at https://www.regulations.gov, Docket No. EPA-R03-OAR-2019-0527. EPA is proposing
to approve MDE's negative declaration submission made on April 3, 2020.
This action applies to the state's regulatory requirements for existing
facilities and not new sources.

II. Proposed Action

    In this proposed action, EPA proposes to amend 40 CFR part 62 to
reflect receipt of the negative declaration letter from MDE certifying
that there are no existing SSI units subject to 40 CFR part 60, subpart
MMMM, in accordance with section 111(d) of the CAA. EPA is soliciting
public comments on the issues discussed in this document. These
comments will be considered before taking final action.

III. Statutory and Executive Order Reviews

    EPA's role with regard to negative declarations for designated
facilities received by EPA from states is to notify the public of the
receipt of such negative declarations and revise 40 CFR part 62
accordingly. This action merely proposes to approve the state's
negative declaration as meeting Federal requirements and does not
impose additional requirements beyond those imposed by state law. For
that reason, this proposed 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);
     Is not an Executive Order 13771 (82 FR 9339, February 2,
2017) regulatory action because SIP approvals are exempted under
Executive Order 12866.
     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 proposed rule, regarding the negative declaration
of SSI units in Maryland, does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because this action 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 62

    Environmental protection, Air pollution control, Administrative
practice and procedure, Sewage sludge incineration units.

    Dated: June 25, 2020.
Cosmo Servidio,
Regional Administrator, Region III.
[FR Doc. 2020-14577 Filed 7-14-20; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 83, Number 137 (Tuesday, July 17, 2018)]
[Proposed Rules]
[Pages 33168-33171]
[FR Doc No: 2018-15147]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R04-OAR-2018-0116; FRL-9980-80--Region 4]

Air Plan Approval; Georgia; Revisions to VOC Definitions and
Ambient Air Quality Standards

AGENCY: Environmental Protection Agency.

ACTION: Proposed rule.

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SUMMARY: On November 13, 2017, the State of Georgia through the Georgia
Environmental Protection Division (EPD), submitted revisions to the
Georgia State Implementation Plan (SIP). The Environmental Protection
Agency (EPA) is proposing to approve SIP revisions, which modify the
State's air quality regulations as incorporated into the SIP.
Specifically, the revisions pertain to definition changes, including
the modification of the definition of ``volatile organic compounds,''
(VOC) and changes to the State's air quality standards for sulfur
dioxide (SO2), particulate matter (both PM2.5 and
PM10), carbon monoxide (CO), ozone (O3), lead
(Pb) and nitrogen dioxide (NO2) to be consistent with the
National Ambient Air Quality Standards (NAAQS). EPA is proposing to
approve these provisions of the SIP revisions because the State has
demonstrated that these changes are consistent with the Clean Air Act
(CAA or Act).

DATES: Comments must be received on or before August 16, 2018.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R04-
OAR-2018-0116 at http://www.regulations.gov. Follow the online
instructions for submitting comments. Once submitted, comments cannot
be edited or removed from Regulations.gov. EPA may publish any comment
received to its public docket. Do not submit electronically any
information you consider to be Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute.
Multimedia submissions (audio, video, etc.) must be accompanied by a
written comment. The written comment is considered the official comment
and should include discussion of all points you wish to make. EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e., on the web, cloud, or other file sharing
system). For additional submission methods, the full EPA public comment
policy, information about CBI or multimedia submissions, and general
guidance on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Tiereny Bell, Air Regulatory
Management Section, Air Planning and Implementation Branch, Air,
Pesticides and Toxics Management Division, U.S. Environmental
Protection Agency, Region 4, 61 Forsyth Street SW, Atlanta, Georgia
30303-8960. The telephone number is<PHONE_NUMBER>. Ms. Bell can also
be reached via electronic mail at [email protected].

I. Background

    In this rulemaking, EPA is proposing to approve changes into the
Georgia SIP, submitted by the State on November 13, 2017. The
submission revises Rule 391-3-1-.01, ``Definitions'' by adding t-Butyl
acetate (also known as tertiary butyl acetate or TBAC) and 1,1,2,2-
Tetrafluoro-1-(2,2,2-trifluoroethoxy) ethane to the list of organic
compounds having negligible photochemical reactivity. The definition of
VOC is also being updated by removing the recordkeeping requirements
for t-Butyl acetate. Finally, the definition of VOC is being revised to
include chemical names to clarify previous exemptions. EPA is also
proposing to approve changes into the Georgia SIP to amend Rule 391-3-
1-.02(4), ``Ambient Air Standards,'' by updating Georgia's air quality
standard to be consistent with the NAAQS. The submittal by the State
can be found in the docket for this rulemaking at www.regulations.gov
and is further summarized below. Also on November 29, 2017, EPD
submitted a separate SIP revision to make changes to Rule 391-3-
1-.03(6), ``Exemption'' under Permits and Rule 391-3-1-.02(7)(a)(1),
``General Requirements'' under Prevention of Significant Deterioration
(PSD). EPA will address these changes in a separate notice.
Additionally, EPD withdrew from EPA's consideration, Rule 391-3-
1-.02(7)(a)2(ix), ``Regulated NSR pollutant'' under PSD, and Rule 391-
3-1-.03(8)(c)(16), ``Additional Provisions for PM2.5 Non-
Attainment Areas'' under Permits.\1\
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    \1\ The State withdrew Rule 391-3-1-.02(7)(a)2(ix), ``Regulated
NSR pollutant'' and Rule 391-3-1-.03(8)(c)(16), ``Additional
Provisions for PM2.5 Non-Attainment Areas'' on December
1, 2016, and July 26, 2017, respectively. The State also
acknowledges this in the response to comment of the pre-hearing in
the November 13, 2017, submittal. The information is in the Docket.

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II. EPA's Analysis of Georgia's SIP Revisions

a. Revisions to Definitions

    Tropospheric ozone, commonly known as smog, occurs when VOC and
nitrogen oxides (NOX) react in the atmosphere in the
presence of sunlight. Because of the harmful health effects of ozone,
EPA and state governments implement rules to limit the amount of
certain VOC and NOX that can be released into the
atmosphere. VOC have different levels of reactivity; they do not react
at the same speed or do not form ozone to the same extent. Section
302(s) of the CAA specifies that EPA has the authority to define the
meaning of ``VOC,'' and hence what compounds shall be treated as VOC
for regulatory purposes.
    EPA determines whether a given carbon compound has ``negligible''
reactivity by comparing the compound's reactivity to the reactivity of
ethane. It has been EPA's policy that compounds of carbon with
negligible reactivity need not be regulated to reduce ozone and should
be excluded from the regulatory definition of VOC. See 42 FR 35314
(July 8, 1977), 70 FR 54046 (September 13, 2005). EPA lists these
compounds in its regulations at 40 CFR 51.100(s) and excludes them from
the definition of VOC. The chemicals on this list are often called
``negligibly reactive.'' EPA may periodically revise the list of
negligibly reactive compounds to add or delete compounds.
    On November 29, 2004,\2\ and August 1, 2016,\3\ EPA issued final
rules revising the definition of VOC by adding new compounds, t-Butyl
acetate and 1,1,2,2-Tetrafluoro-1-(2,2,2-trifluoroethoxy) ethane, to
the list of those considered to be negligibly reactive compounds, and
on February 25, 2016 (81 FR 9339), EPA issued a final rule removing
recordkeeping, emissions reporting, photochemical dispersion modeling,
and inventory requirements for t-Butyl acetate.\4\ The State's November
13, 2017, SIP revision adds t-Butyl acetate and 1,1,2,2-Tetrafluoro-1-
(2,2,2-trifluoroethoxy) ethane to the list of negligibly reactive
compounds to be consistent with federal and other similar SIP-approved
regulations. They are excluded from the VOC definition on the basis
that they make a negligible contribution to tropospheric ozone
formation. The revision also removes the recordkeeping requirements for
t-Butyl acetate and includes the addition of certain chemical names to
clarify previous exemptions: Dichloromethane; HFE-7100; HFE-7200;
HCOOCH3; and HFE-7300. EPA is proposing to approve this revision
because it is consistent with the definition of VOC at 40 CFR
51.100(s).
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    \2\ In EPA's November 29, 2004, final rulemaking, the Agency
adds t-Butyl acetate to the list of excluded compounds from the
definition of VOCs. See 69 FR 69298.
    \3\ In EPA's August 1, 2016, final rulemaking, the Agency adds
1,1,2,2-Tetrafluoro-1-(2,2,2-trifluoroethoxy) ethane to the list of
excluded compounds from the definition of VOCs. See 81 FR 50330.
    \4\ EPA removed these requirements in part because there was no
evidence that TBAC was being used at levels that cause concern for
ozone formation and because the data that had been collected under
these requirements had proven to be of limited utility in judging
the cumulative impacts of exempted compounds. See 81 FR 9339.
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    Pursuant to CAA section 110(l), 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, or any other applicable requirement of the Act. The State's
addition of certain chemical names is approvable under section 110(l)
because the revision merely clarifies previous exemptions. The State's
addition of exemptions from the definition of VOCs, and the removal of
recordkeeping, emissions reporting, photochemical dispersion modeling,
and inventory requirements for t-Butyl acetate \5\ are approvable under
section 110(l) because they reflect changes to Federal regulations
based on findings that the exempted compounds are negligibly reactive,
and additionally for t-Butyl acetate, that there was no evidence it was
being used at levels that cause concern for ozone formation, and the
data that had been collected under the recordkeeping, emissions
reporting, photochemical dispersion modeling, and inventory
requirements had proven to be of limited utility in judging it's
cumulative impact.
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    \5\ This current proposed rulemaking does not, and is not
intended to, reopen any prior final EPA rulemaking or findings made
therein, including EPA's 2004 final rule (69 FR 69298) and EPA's
2016 final rule (81 FR 9339).
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b. Updated NAAQS

    The November 13, 2017, SIP submission revises the State's ambient
air quality standards to reflect the historical and current NAAQS for
SO2, PM10, PM2.5, CO, O3,
Pb, and NO2. Specifically, the revisions add provisions
related to the 2015 ozone NAAQS to the State's regulations, and modify
language in the regulations to provide clarity and consistency with the
NAAQS.
    Sections 108 and 109 of the CAA govern the establishment, review,
and revision, as appropriate, of the NAAQS to protect public health and
welfare. The CAA requires periodic review of the air quality criteria--
the science upon which the standards are based--and the standards
themselves. EPA's regulatory provisions that govern the NAAQS are found
at 40 CFR 50--National Primary and Secondary Ambient Air Quality
Standards. In this rule, EPA is proposing to approve the portions of
the revisions to the State of Georgia air quality regulations
addressing Rule 391-3-1-.02(4), Ambient Air Standards, in the Georgia
SIP, submitted by Georgia on November 13, 2017. Rule 391-3-1-.02(4) is
amended by updating air quality standards to reflect the most recent
NAAQS. The SIP submission amending the State of Georgia regulations to
incorporate the most recent SO2, particulate matter (both
PM2.5 and PM10), CO, O3, Pb and
NO2 NAAQS can be found in the docket for this rulemaking at
www.regulations.gov and is summarized below.
i. SO2
    On June 22, 2010, EPA promulgated a revised primary SO2
NAAQS to an hourly standard of 75 parts per billion (ppb), based on a
3-year average of the annual 99th percentile of 1-hour daily maximum
concentrations, and revoked the 24-hour SO2 NAAQS. See 75 FR
35520. Accordingly, in the November 13, 2017, SIP submission, Georgia
revised Rule 391-3-1-.02(4)(b) to update its primary air quality
standards for SO2 to be consistent with the NAAQS
promulgated by EPA in 2010, with the exception of Rule 391-3-
1-.02(4)(b)2 and 391-3-1-.02(4)(b)3.\6\ EPA is proposing to approve
this change because it is consistent with the SO2 NAAQS as
defined by EPA.
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    \6\ The former primary SO2 NAAQS set forth in 40 CFR
50.4 will continue to apply to an area until one year after the
effective date of the designation of that area, pursuant to section
107 of the CAA, for the 2010 SO2 NAAQS set forth in Sec.
50.17. Therefore, Georgia is asking that EPA not act on the
SO2 NAAQS in Rule 391-3-1-.02(4)(b)2. and Rule 391-3-
1-.02(4)(b)3 until final designations are complete for all areas in
Georgia for the 2010 SO2 NAAQS.
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ii. PM
    On July 18, 1997, EPA promulgated a new 24-hour primary and
secondary NAAQS for PM2.5 at a level of 65 micrograms per
cubic meter ([micro]g/m\3\), based on the 98th percentile of 24-hour
PM2.5 concentrations averaged over three years. EPA also
promulgated a new annual primary and secondary NAAQS for
PM2.5 at a level of 15.0 [micro]g/m\3\, based on the annual
arithmetic

mean averaged over three years. See 62 FR 38652. On October 17, 2006,
EPA revised the 24-hour primary and secondary PM2.5 NAAQS to
35 [micro]g/m\3\, based on the 98th percentile of 24-hour
PM2.5 concentrations averaged over three years. At that same
time, EPA revoked the annual PM10 NAAQS. See 71 FR 61144. On
December 14, 2012, EPA revised the primary annual NAAQS for
PM2.5 at a level of 12 [micro]g/m\3\, based on the annual
arithmetic mean averaged over three years. See 78 FR 3085; January 15,
2013. Accordingly, in the November 13, 2017, SIP submission, Georgia
revised Rule 391-3-1-.02(4) to update its air quality standards for
PM10 and PM2.5 to be consistent with the NAAQS
promulgated by EPA in 1997, 2006, and 2012. EPA is proposing to approve
this change because it is consistent with the PM10 and
PM2.5 NAAQS as defined by EPA.
iii. CO
    EPA initially established the NAAQS for CO on April 30, 1971. The
standards were set at 9 parts per million (ppm), as an 8-hour average,
and 35 ppm, as a 1-hour average, neither to be exceeded more than once
per year. See 36 FR 8186. In 1985, EPA concluded its first periodic
review of the criteria and standards for CO. EPA decided not to revise
the existing primary standards and to revoke the secondary standard for
CO. See 50 FR 37484 (September 13, 1985). On August 1, 1994, EPA
concluded its second periodic review of the criteria and standards for
CO by deciding that revisions to the CO NAAQS were not warranted at
that time. Thus, the primary standards were retained at 9 ppm with an
8-hour averaging time, and 35 ppm with a 1-hour averaging time, neither
to be exceeded more than once per year. See 59 FR 38906.\7\ On August
31, 2011, EPA issued a final rulemaking concluding that the CO NAAQS
was still requisite to protect public health with an adequate margin of
safety and thus retained the CO NAAQS. See 76 FR 542494. Accordingly,
in the November 13, 2017, SIP submission, Georgia revised Rule 391-3-
1-.02(4) to update its air quality standards for CO to be consistent
with the current CO NAAQS. EPA is proposing to approve this change
because it is consistent with the CO NAAQS as defined by EPA.
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    \7\ EPA initiated the next period review in 1997 but did not
conduct rulemaking to complete the review.
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iv. O3
    On March 27, 2008, EPA promulgated a new 8-hour primary and
secondary NAAQS for ozone at a level of 0.075 ppm (the 2008 8-hour
Ozone NAAQS), based on an annual fourth-highest maximum 8-hour
concentration averaged over three years. See 73 FR 16436. On October
26, 2015, EPA promulgated a new primary and secondary NAAQS for ozone
at a level of 0.070 ppm (the 2015 8-hour Ozone NAAQS), based on an
annual fourth-highest maximum 8-hour concentration averaged over three
years. See 80 FR 65292. Accordingly, in the November 13, 2017, SIP
submission, Georgia revised Rule 391-3-1-.02(4) to add the 2015 8-hour
Ozone NAAQS promulgated by EPA in 2015. EPA is proposing to approve
this change because it is consistent with the ozone NAAQS as defined by
EPA.
v. Pb
    On November 12, 2008, EPA promulgated a new 1-hour primary and
secondary NAAQS for Pb at a level of 0.15 [mu]g/m\3\, based on a
rolling 3-month average. See 73 FR 66964. Accordingly, in the November
13, 2017, SIP submission, Georgia revised Rule 391-3-1-.02(4) to update
its air quality standards for Pb to be consistent with the NAAQS
promulgated by EPA in 2008. EPA is proposing to approve this change
because it is consistent with the Pb NAAQS as defined by EPA.
vi. NO2
    On February 9, 2010, EPA promulgated a new 1-hour primary NAAQS for
NO2 at a level of 100 parts per billion (ppb), based on a 3-
year average of the 98th percentile of the yearly distribution of 1-
hour daily maximum concentrations. See 75 FR 6474. Accordingly, in the
November 13, 2017, SIP submission, Georgia revised Rule 391-3-1-.02(4)
to update its air quality standards for NO2 to be consistent
with the NAAQS promulgated by EPA in 2010. EPA is proposing to approve
this change because it is consistent with the NO2 NAAQS as
defined by EPA.
    EPA has reviewed the revisions to Rule 391-3-1-.02(4) in the
November 13, 2017, SIP submission, including the NAAQS updates for
SO2, PM10, PM2.5, CO, O3,
Pb, and NO2, and has made the preliminary determination that
these changes are consistent with the CAA. As mentioned above, EPA is
proposing to approve these changes to the NAAQS into the Georgia SIP.

III. Incorporation by Reference

    In this document, EPA is proposing to include in a final EPA rule
regulatory text that includes incorporation by reference. In accordance
with requirements of 1 CFR 51.5, EPA is proposing to incorporate by
reference Georgia Rule 391-3-1-.01, ``Definitions,'' effective July 20,
2017, which revises the definition of VOC; and Rule 391-3-1-.02(4),
``Ambient Air Standards,'' effective July 20, 2017, which revises the
State's ambient air quality standards to be consistent with the NAAQS.
EPA has made, and will continue to make, these materials generally
available through www.regulations.gov and at the EPA Region 4 Office
(please contact the person identified in the For Further Information
Contact section of this preamble for more information).

IV. Proposed Action

    EPA is proposing to approve the State of Georgia's November 13,
2017, SIP revisions identified in section II above. These changes are
consistent with the CAA.

V. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations. See 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. This action merely
proposes to approve state law as meeting Federal requirements and does
not impose additional requirements beyond those imposed by state law.
For that reason, this proposed 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);
     Is not an Executive Order 13771 (82 FR 9339, February 2,
2017) regulatory action because SIP approvals are exempted under
Executive Order 12866.
     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).
    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 as specified by Executive Order 13175 (65
FR 67249, November 9, 2000), nor will it impose substantial direct
costs on tribal governments or preempt tribal law.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide,
Incorporation by reference, Intergovernmental relations, Lead, Nitrogen
dioxide, Ozone, Particulate matter, Reporting and recordkeeping
requirements, Sulfur oxides, Volatile organic compounds.

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

    Dated: July 2, 2018.
Onis ``Trey'' Glenn, III,
Regional Administrator, Region 4.
[FR Doc. 2018-15147 Filed 7-16-18; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register: March 2, 2007 (Volume 72, Number 41)]
[Rules and Regulations]
[Page 9441-9445]
[DOCID:fr02mr07-5]

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

40 CFR Part 52

[EPA-R03-OAR-2006-0921; FRL-8282-9]

Approval and Promulgation of Air Quality Implementation Plans;
Virginia; Amendments to VOC and NOX Emission Control Areas and VOC
Control Regulations

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: EPA is approving State Implementation Plan (SIP) revisions
submitted by the Commonwealth of Virginia. These revisions amend
existing volatile organic compound (VOC) and nitrogen oxide
(NOX) emissions control areas, and amend certain VOC and
NOX regulations in order to manage the extension of
applicability of these provisions to the amended VOC and NOX
emission control areas. EPA is approving these revisions in accordance
with the requirements of the Clean Air Act (CAA).

EFFECTIVE DATE: This final rule is effective on April 2, 2007.

ADDRESSES: EPA has established a docket for this action under Docket ID
Number EPA-R03-OAR-2006-0921. All documents in the docket are listed in
the http://www.regulations.gov Web site. Although listed in the

electronic docket, some information is not publicly available, i.e.,
confidential business information (CBI) or other information whose
disclosure is restricted by statute. Certain other material, such as
copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available either electronically through http://www.regulations.gov
 or in hard copy for public inspection during normal

business hours at the Air Protection Division, U.S. Environmental
Protection Agency, Region III, 1650 Arch Street, Philadelphia,
Pennsylvania 19103. Copies of the State submittal are available at the
Virginia Department of Environmental Quality, 629 East Main Street,
Richmond, Virginia 23219.

FOR FURTHER INFORMATION CONTACT: Ellen Wentworth,<PHONE_NUMBER>, or by
e-mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    On December 26, 2006 (71 FR 77353), EPA published a notice of
proposed rulemaking (NPR) for the Commonwealth of Virginia. The NPR
proposed approval of amendments to 9 VAC 5 Chapter 20, Volatile Organic
Compound and Nitrogen Oxides Emissions Control Areas, (9 VAC 5-20-206),
and also proposed approval of amendments to 9 VAC 5 Chapter 40,
Articles 4, Emission Standards for General Process Operations; Article
36, Emission Standards for Flexographic, Packaging Rotogravure, and
Publication Rotogravure Printing Lines; Article 37, Emission Standards
for Petroleum Liquid Storage and Transfer Operations; and Article 53,
Emission Standards for Lithographic Printing Processes. The formal SIP
revisions were submitted by the Commonwealth of Virginia on September
12, 2006, and October 2, 2006.

II. Summary of SIP Revisions

    The September 12, 2006 formal SIP revision consists of amendments
to 9 VAC 5-20-206 of Chapter 20, Volatile Organic Compound and Nitrogen
Oxides Emission Control Areas. Specifically, this revision creates a
new VOC and NOX emissions control area (the Fredericksburg
Area), consisting of Spotsylvania County and Fredericksburg City, and
expands the existing Richmond VOC and NOX Emissions Control
Areas to include Prince George County and Petersburg City. In addition
this revision expands the existing Hampton Roads VOC and NOX
Emissions Control Areas to include Gloucester and Isle of Wight
Counties. These amendments are necessary to implement VOC control and
contingency measures within the 8-hour ozone nonattainment areas and 1-
hour ozone maintenance areas.
    The October 2, 2006 formal SIP revision consists of amendments to 9
VAC 5 Chapter 40 that implement non-CTG and CTG VOC RACT control
requirements within those areas that are designated as VOC emissions
control areas. While most of the Chapter 40 rules apply to sources of
VOCs in VOC emissions control areas designated in Chapter 20, 9 VAC 5-
206, certain Chapter 40 rules (specifically Articles 4, 36, 37, and 53)
have provisions mandating that these regulations apply only to certain
VOC and NOX emission control areas. Article 4, Emission
Standards for General Process Operations is being amended to ensure
that VOC RACT is not required from large VOC sources in the new areas
within the expanded Richmond VOC Emissions Control Areas; Article 36,
Packaging and Publishing Rotogravure Printing, and Flexographic
Printing, is being amended to add appropriate exemptions for small
facilities in those VOC emissions control areas that currently have no
such exemptions; and Article 37, Storage or Transfer of Petroleum
Liquids, is also being amended to ensure that Stage II Vapor Recovery
is not required at gasoline dispensing stations in the new areas within
the expanded Richmond VOC Emissions Control Area. Lastly, Article 53,
Lithographic Printing, is being amended to apply in all VOC emissions
control areas instead of just in the Northern Virginia and Richmond VOC
Emissions Control Areas, and is also being amended to provide
appropriate exemptions for small facilities in the newly applicable VOC
emissions control areas. In this rulemaking, EPA is also recodifying
the lithographic printing rule (9 VAC 5-40-7800-7940, inclusive) as
Article 53 and Rule 4-53. Other specific requirements and the rationale
for EPA's proposed action are explained in the NPR and will not be
restated here. No public comments were received on the NPR.

III. General Information Pertaining to SIP Submittals From the
Commonwealth of Virginia

    In 1995, Virginia adopted legislation that provides, subject to
certain conditions, for an environmental assessment (audit)
``privilege'' for voluntary compliance evaluations performed by a
regulated entity. The legislation further addresses the relative burden
of proof for parties either asserting the privilege or seeking
disclosure of documents for which the privilege is claimed. Virginia's
legislation also provides, subject to certain conditions, for a penalty
waiver for violations of environmental laws when a regulated entity
discovers such violations pursuant to a voluntary compliance evaluation
and voluntarily discloses such violations to the Commonwealth and takes
prompt and appropriate measures to remedy the violations. Virginia's
Voluntary Environmental Assessment Privilege Law, Va. Code Sec. 10.1-
1198, provides a privilege that protects from disclosure documents and
information about the content of those documents that are the product
of a voluntary environmental assessment. The Privilege Law does not
extend to documents or information (1) that are generated or developed
before the commencement of a voluntary environmental assessment; (2)
that are prepared independently of the assessment process; (3) that
demonstrate a clear, imminent and substantial danger to the public
health or environment; or (4) that are required by law.
    On January 12, 1998, the Commonwealth of Virginia Office of the
Attorney General provided a legal opinion that states that the
Privilege law,Va. Code Sec. 10.1-1198, precludes granting a privilege
to documents and information ``required by law,'' including documents
and information ``required by Federal law to maintain program
delegation, authorization or approval,'' since Virginia must ``enforce
Federally authorized environmental programs in a manner that is no less
stringent than their Federal counterparts * * * .'' The opinion
concludes that ``[r]egarding Sec.  10.1-1198, therefore, documents or
other information needed for civil or criminal enforcement under one of
these programs could not be privileged because such documents and
information are essential to pursuing enforcement in a manner required
by Federal law to maintain program delegation, authorization or
approval.''
    Virginia's Immunity law, Va. Code Sec. 10.1-1199, provides that
``[t]o the extent consistent with requirements imposed by Federal
law,'' any person making a voluntary disclosure of information to a
state agency regarding a violation of an environmental statute,
regulation, permit, or administrative order is granted immunity from
administrative or civil penalty. The Attorney General's January 12,
1998 opinion states that the quoted language renders this statute
inapplicable to enforcement of any Federally authorized programs, since
``no immunity could be afforded from administrative, civil, or criminal
penalties because granting such immunity would not be consistent with
Federal law, which is one of the criteria for immunity.''
    Therefore, EPA has determined that Virginia's Privilege and
Immunity statutes will not preclude the Commonwealth from enforcing its
program consistent with the Federal requirements. In any event, because
EPA has also determined that a state audit privilege and immunity law
can affect only state enforcement and cannot have any impact on Federal
enforcement authorities, EPA may at any time invoke its authority under
the Clean Air Act, including, for example, sections 113, 167, 205, 211
or 213, to enforce the requirements or prohibitions of the state plan,
independently of any state enforcement effort. In addition, citizen
enforcement under section 304 of the Clean Air Act is likewise
unaffected by this, or any, state audit privilege or immunity law.

IV. Final Action

    EPA is approving Virginia SIP revisions submitted on September 12,
and October 2, 2006, amending the VOC and NOX emission
control areas found in Chapter 20, and amending certain provisions
found in Chapter 40 which implement non-CTG and CTG VOC RACT control
requirements within certain areas designated as VOC emissions control
areas.

V. Statutory and Executive Order Reviews

A. General Requirements

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), this
action is not a ``significant regulatory action'' and therefore is not
subject to review by the Office of Management and Budget. For this
reason, this action is also not subject to Executive Order 13211,
``Actions Concerning Regulations That

Significantly Affect Energy Supply, Distribution, or Use'' (66 FR
28355, May 22, 2001). This action merely approves state law as meeting
Federal requirements and imposes no additional requirements beyond
those imposed by state law. Accordingly, the Administrator certifies
that this rule will not have a significant economic impact on a
substantial number of small entities under the Regulatory Flexibility
Act (5 U.S.C. 601 et seq.). Because this rule approves pre-existing
requirements under state law and does not impose any additional
enforceable duty beyond that required by state law, it 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). This rule also does not have tribal implications
because it will not have a substantial direct effect on one or more
Indian tribes, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes, as specified by
Executive Order 13175 (65 FR 67249, November 9, 2000). This action also
does not have Federalism implications because it does not have
substantial direct effects on the States, on the relationship between
the national government and the States, or on the distribution of power
and responsibilities among the various levels of government, as
specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This
action merely approves a state rule implementing a Federal requirement,
and does not alter the relationship or the distribution of power and
responsibilities established in the Clean Air Act. This rule also is
not subject to Executive Order 13045 (62 FR 19885, April 23, 1997),
because it approves a state rule implementing a Federal standard.
    In reviewing SIP submissions, EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act. In
this context, in the absence of a prior existing requirement for the
State to use voluntary consensus standards (VCS), EPA has no authority
to disapprove a SIP submission for failure to use VCS. It would thus be
inconsistent with applicable law for EPA, when it reviews a SIP
submission, to use VCS in place of a SIP submission that otherwise
satisfies the provisions of the Clean Air Act. Thus, the requirements
of section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (15 U.S.C. 272 note) do not apply. This rule does not
impose an information collection burden under the provisions of the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).

B. Submission to Congress and the Comptroller General

    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 rule 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. This rule is not a
``major rule'' as defined by 5 U.S.C. 804(2).

C. Petitions for Judicial Review

    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 May 1, 2007. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this rule 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, pertaining to amendments to Chapter 20 and
Chapter 40 of Virginia's regulations, 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, Nitrogen dioxide,
Ozone, Reporting and recordkeeping requirements, Volatile organic
compounds.

    Dated: February 21, 2007.
Donald S. Welsh,
Regional Administrator, Region III.

0
40 CFR Part 52 is amended as follows:

PART 52--[AMENDED]

0
1. The authority citation for 40 CFR part 52 continues to read as
follows:

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

Subpart VV--Virginia

0
2. In Sec.  52.2420, the table in paragraph (c) is amended by:
0
a. Revising the entries for 5-20-206, 5-40-300, 5-40-5060, and 5-40-
5200.
0
b. For Chapter 40, Part II, removing the entry for Article 45 and
replacing it with an entry for Article 53.

Sec.  52.2420  Identification of plan.

* * * * *
    (c) * * *

                                 EPA-Approved Virginia Regulations and Statutes
----------------------------------------------------------------------------------------------------------------
                                                            State                            Explanation [former
   State citation  (9 VAC 5)         Title/subject     effective date   EPA approval  date      SIP citation]
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                                         Chapter 20--General Provisions
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                                          Part II--Air Quality Programs
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
5-20-206.......................  Volatile organic            10/04/06  3/2/07 [Insert page   Addition of new
                                  compound and                          number where the      Fredericksburg
                                  nitrogen oxides                       document begins].     area and expansion
                                  emissions control                                           of Richmond and
                                  areas.                                                      Hampton Roads
                                                                                emission control
                                                                                areas

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                                     Chapter 40--Existing Stationary Sources
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                                           Part II--Emission Standards
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                     Article 4--Emission Standards for General Process Operations (Rule 4-4)
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
5-40-300.......................  Standard for                10/04/06  3/2/07 [Insert page
                                  volatile organic                      number where the
                                  compounds.                            document begins.

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
     Article 36--Flexographic, Packaging Rotogravure, and Publication Rotogravure Printing Lines (Rule 4-36)
----------------------------------------------------------------------------------------------------------------
5-40-5060......................  Applicability and           04/01/96  3/2/07 [Insert page
                                  designation of             10/04/06   number where the
                                  affected facility.                    document begins.

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
         Article 37--Emission Standards for Petroleum Liquid Storage and Transfer Operations (Rule 4-37)
----------------------------------------------------------------------------------------------------------------
5-40-5200......................  Applicability and           04/01/96  3/2/07 [Insert page
                                  designation of             10/04/06   number where the
                                  affected facility.                    document begins.

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
      Article 53--Emission Standards for Lithographic Printing Processes (Rule 4-53) [Formerly Article 45]
----------------------------------------------------------------------------------------------------------------
5-40-7800......................  Applicability and           10/04/06  3/2/07 [Insert page   Revised to include
                                  designation of                        number where the      and exempt certain
                                  affected facility.                    document begins.      emission control
                                                                                areas.
5-40-7810......................  Definitions of              04/01/96  3/2/07 Insert page
                                  ``alcohol,''               10/04/06   number where the
                                  ``Cleaning                            document begins.
                                  solution,''
                                  ``fountain
                                  solution,''
                                  ``lithographic
                                  printing,''
                                  ``printing
                                  process''.
5-40-7820......................  Standard for                04/01/96  3/2/07 Insert page
                                  Volatile Organic           10/04/06   number where the
                                  Compounds.                            document begins.
5-40-7840......................  Standard for Visible        04/01/96  3/2/07 [Insert page
                                  Emissions.                 10/04/06   number where the
                                                                        document begins.
5-40-7850......................  Standard for                04/01/96  3/2/07 [Insert page
                                  Fugitive Dust              10/04/06   number where the
                                  Emissions.                            document begins.
5-40-7880......................  Compliance..........        10/04/06  3/2/07 [Insert page   Revisions to
                                                                        number where the      compliance dates.
                                                                        document begins.
5-40-7890......................  Test Methods and            04/01/96  3/2/07 [Insert page
                                  Procedures.                10/04/06   number where the
                                                                        document begins.
5-40-7900......................  Monitoring..........        04/01/96  3/2/07 [Insert page
                                                             10/04/06   number where the
                                                                        document begins.
5-40-7910......................  Notification,               04/01/96  3/2/07 [Insert page
                                  Records and                10/04/06   number where the
                                  Reporting.                            document begins.
5-40-7920......................  Registration........        04/01/96  3/2/07 [Insert page
                                                             10/04/06   number where the
                                                                        document begins.
5-40-7930......................  Facility and Control        04/01/96  3/2/07 [Insert page
                                  Equipment                  10/04/06   number where the
                                  Maintenance and                       document begins.
                                  Malfunction.
5-40-7940......................  Permits.............        04/01/96  3/2/07 [Insert page
                                                             10/04/06   number where the
                                                                        document begins.

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *
 [FR Doc. E7-3586 Filed 3-1-07; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 85, Number 182 (Friday, September 18, 2020)]
[Notices]
[Pages 58366-58370]
[FR Doc No: 2020-20614]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1644]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Medical Conference Attendees' Observations about
Prescription Drug Promotion

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information and to
allow 60 days for public comment in response to the notice. This notice
solicits comments on a proposed study entitled ``Medical Conference
Attendees' Observations about Prescription Drug Promotion.''

DATES: Submit either electronic or written comments on the collection
of information by November 17, 2020.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before November 17, 2020. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of November 17, 2020. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2020-N-1644 for ``Medical Conference Attendees' Observations about
Prescription Drug Promotion.'' Received comments, those filed in a
timely manner (see ADDRESSES), will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at https://www.regulations.gov or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>    For copies of the questionnaire contact: Office of Prescription
Drug Promotion (OPDP) Research Team<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information before
submitting the collection to OMB for approval. To comply with this
requirement, FDA is publishing notice of the proposed collection of
information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Medical Conference Attendees' Observations About Prescription Drug
Promotion

OMB Control Number 0910--NEW

    Section 1701(a)(4) of the Public Health Service Act (42 U.S.C.
300u(a)(4)) authorizes the FDA to conduct research relating to health
information. Section 1003(d)(2)(C) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C. 393(d)(2)(C)) authorizes FDA to
conduct research relating to drugs and other FDA regulated products in
carrying out the provisions of the FD&C Act.
    The Office of Prescription Drug Promotion's (OPDP) mission is to
protect the public health by helping to ensure that prescription drug
promotion is truthful, balanced, and accurately communicated. OPDP's
research program provides scientific evidence to help ensure that our
policies related to prescription drug promotion will have the greatest
benefit to public health. Toward that end, we have consistently
conducted research to evaluate the

aspects of prescription drug promotion that are most central to our
mission. Our research focuses in particular on three main topic areas:
(1) Advertising features, including content and format; (2) target
populations; and (3) research quality. Through the evaluation of
advertising features we assess how elements such as graphics, format,
and disease and product characteristics impact the communication and
understanding of prescription drug risks and benefits. Focusing on
target populations allows us to evaluate how understanding of
prescription drug risks and benefits may vary as a function of
audience. Our focus on research quality aims at maximizing the quality
of our research data through analytical methodology development and
investigation of sampling and response issues. This study will inform
the first and second topic areas: Advertising features and target
populations.
    Because we recognize the strength of data and the confidence in the
robust nature of the findings is improved through the results of
multiple converging studies, we continue to develop evidence to inform
our thinking. We evaluate the results from our studies within the
broader context of research and findings from other sources, and this
larger body of knowledge collectively informs our policies as well as
our research program. Our research is documented on our homepage, which
can be found at: https://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cder/ucm090276.htm. The website
includes links to the latest Federal Register notices and peer-reviewed
publications produced by our office. The website maintains information
on studies we have conducted, dating back to a survey of direct-to-
consumer (DTC) advertising conducted in 1999.
    The current study focuses on understanding the landscape of
healthcare provider (HCP)-directed promotion of prescription drugs at
medical conferences in general and, more specifically, how elements of
pharmaceutical booths in medical conference exhibit halls impact HCP
attendees' perceptions of the drugs that are promoted at those booths.
We will first ask attendees, who are prescribers within different
disciplines (primary care physicians, specialists, nurse practitioners,
and physician assistants), general questions about their attendance at
medical conferences, including: (1) Questions about their motivations
for attending, (2) activities they participate in (e.g., symposia,
poster sessions, social events, exhibit halls), and (3) their opinions
about the prescription drug treatments promoted at medical conferences.
These questions will allow us to capture the viewpoint of prescribers
who attend medical conferences where prescription treatments are
discussed and promoted.
    The second part of our study will allow us to get more detailed
information about interactions in medical conference exhibit halls. A
2006 study found that at least 80 percent of physicians attended at
least 1 medical conference each year and spent an average of 7 hours on
the exhibit hall floor at each event (Ref. 1). The length of time spent
at each booth--between 12 and 21 minutes (Ref. 1)--was comparatively
longer than detailing visits in HCP offices, which range from 5 to 10
minutes on average (Refs. 2 and 3). Thus, medical conference exhibit
booths provide opportunities for pharmaceutical companies to market to
large numbers of HCPs and potentially engage in more lengthy
interactions.
    Promotional booths for prescription drugs and the promotional
materials disseminated at those booths fall within the regulatory
purview of OPDP. As with other promotional materials for prescription
drugs, pharmaceutical companies may voluntarily submit draft versions
of their exhibit panels and exhibit materials for FDA review (Ref. 4).
This study is designed to provide insights to inform the advisory
comments that OPDP provides to pharmaceutical companies that
voluntarily seek FDA review. OPDP also monitors prescription drug
promotional booths and materials as part of its surveillance program.
Recent compliance letters issued by OPDP described booth or panel
displays that communicated misleading information regarding drug
efficacy and safety, provided insufficient information on drug risks,
and omitted ''material facts'' about the promoted drug (Ref. 5). A
primary reason that physicians and other medical professionals report
visiting specific exhibitors at conferences is to obtain product
information (Ref. 1), and it is important that the information provided
by exhibitors to HCPs regarding the risks and efficacy of prescription
medications not be misleading. Thus, investigating the impact of
pharmaceutical booth promotions among medical conference attendees has
valuable practical implications for the public health.
    As part of our specific exhibit booth research, we will simulate
interactions that HCPs may have at medical conference booths promoting
prescription drugs, so that FDA can examine the effects of the booth
representative's background (scientist/medical professional versus
business professional) and disclosure of data limitations (present
versus absent). In a recent survey, HCP conference attendees reported
that interacting with company representatives was the most important
element of their booth visits, followed by the availability and quality
of clinical information (Ref. 4). Thus, the perceived credibility of
the booth representative and the availability of information on data
limitations could ultimately inform HCPs' perceptions of the risks and
benefits of drugs presented at exhibit booths and their decisions to
prescribe drugs to patients.
    Indeed, literature suggests that credibility and disclosures are
relevant elements to study in the context of prescription drug
conference booths. Credibility is linked to extrinsic (physical
attractiveness, power) and intrinsic (delivery factors, linguistic
cues) factors. For example, one extrinsic feature of source credibility
is similarity between the source and recipient. Research on the effects
of source similarity has been mixed, but a classic field experiment by
Brock in 1965 found that customers buying paint were more likely to
follow recommendations of a salesperson they perceived as having
painting experiences similar to their own (Ref. 6). More recent studies
have examined the effects of endorsers with professional expertise
versus those with product experience on attitudes toward the brand and
promotion (Refs. 7 and 8). These past studies are relevant to our
manipulations of booth representative background in this study given
that representatives with a medical/science background may reflect
professional expertise, whereas representatives with a business
background may reflect product experience.
    There is little empirical evidence on the impact of disclosing data
limitations during promotional detailing or other sales promotion. On
one hand, providing important information (e.g., key limitations) about
the data/drug should help increase comprehension and decrease
inaccurate or unjustified interpretations of the data. On the other
hand, seeing the disclosure of data limitations--essentially tempering
the study findings and providing a sort of two-sided information that
is not necessarily in favor of the drug's effects--may improve the
material's credibility and appeal by signifying more transparency on
the sponsor's part (Ref. 9), and therefore lead to greater interest in
the drug (regardless of accurate comprehension). Conversely, not seeing
any qualifying or clarifying information could raise red flags among

providers, resulting in the lowest levels of perceived credibility.
Whether the booth representative has a medical/science background or
business background may shape perceptions of credibility even further,
thereby influencing HCPs' perceptions of the drug. Thus, while
disclosure of data limitations and credibility of the booth
representative may have independent effects on HCPs' comprehension and
perceptions, these variables could also interact in their effects.

I. Research Questions

    With this background in mind, we plan to address the issue of how
firms communicate about prescription drugs from the perspective of
medical conference/exhibit hall attendees. Specifically, we will ask
for attendees' general observations of:
    1. Disclosures or disclaimers accompanying exhibit hall
presentations and/or symposia (about data limitations, contrary data,
FDA approval status, financial/affiliation sponsorship, etc.);
    2. publications or references accompanying the presentation of
information (PI for approved indications, contrary data references,
etc.);
    3. what type of studies are being reported (real world evidence,
pharmacokinetic/pharmacodynamic studies, meta-analyses, etc.).
    4. who makes the presentations (field of study, training); and
    5. where the presentations are made (poster session, scientific
floor, exhibit hall).
    We will also address exhibit hall pharmaceutical booth
interactions, specifically:
    1. How does the presence or absence of information about the
limitations of data influence perceptions of the promoted product?
    2. How does the background of the booth representative influence
perceptions of the promoted product?
    3. Do these two variables interact?

II. Method

    To complete this research, we will recruit attendees of large
medical conferences in the United States over the course of 1 year.
These conferences will represent a variety of specialties to reflect
medical areas that have prescription treatments that may be promoted to
HCPs. Specifically, we will enroll HCPs who attended one of 12 selected
medical conferences into an online survey within 7 days of conference
attendance. Exhibit 1 summarizes our approach to: (1) Determining the
conference sampling frame; (2) determining the attendee sampling frame;
and (3) recruiting and enrolling the target sample in the online
survey.
[GRAPHIC] [TIFF OMITTED] TN18SE20.299

    In the first step, we will select conferences that focused on
therapeutic areas that have the following attributes:
     High number of currently promoted branded medications;
     high volume of prescriptions written;
     large patient population; and
     high amount of new drug development and promotional
spending.
    Table 1 shows the final criterion for conference inclusion.
Conferences that meet these criteria will be selected based on an
environmental scan.

                Table 1--Conference Eligibility Criteria
------------------------------------------------------------------------
               Criterion                            Parameters
------------------------------------------------------------------------
Therapeutic area.......................  Associated with one of the
                                          prioritized therapeutic areas.
Conference attendance..................  Estimated attendance of 5,000
                                          or more individuals.
Target audience........................  Focused on prescribers and
                                          clinicians (e.g., not
                                          insurers).
Event date.............................  Scheduled during August 2021--
                                          August 2022.
Event location.........................  Domestic (within United
                                          States).
------------------------------------------------------------------------

    Following conference selection, medical conference attendees at
each conference will be randomly selected, invited to participate, and
screened to ensure they are HCPs with prescribing authority who
responded to the survey invitation within 7 days of attending the
target conference. HCPs will be limited to physicians, nurse
practitioners, and physician assistants who spend 20 percent or more
time in direct patient care, are able to read and speak English, are
not currently employed by the Federal government or a pharmaceutical
company (not including occasional consulting), and have not
participated in another wave of the project.

    The online survey will be broken into two main parts: (1) A cross-
sectional survey designed to capture HCP observations from the medical
conference and (2) an experimental study designed to assess how data
disclosures and exhibit booth representative background influence HCP
perceptions of promoted prescription drugs. The cross-sectional part of
the survey will contain a series of close- and open-ended questions.
The experimental study part of the survey will ask participants to view
a brief video simulating a conference exhibit hall interaction between
an HCP attendee and a booth employee and then answer questions about a
fictitious prescription drug featured in the video. Table 2 shows our
proposed study design and sample size across 12 conferences.

              Table 2--Study Design and Target Sample Sizes
------------------------------------------------------------------------
                                              Booth employee
                                                background
                Disclosure                ----------------------  Total
                                            Business   Medical
------------------------------------------------------------------------
Present..................................     n = 92     n = 92      184
Absent...................................     n = 92     n = 92      184
    Total................................        184        184      368
------------------------------------------------------------------------

    FDA estimates the burden of this collection of information as
follows:

                                 Table 3--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                   Number of
           Activity                Number of     responses per   Total annual    Average burden     Total hours
                                  respondents     respondent       responses      per response
----------------------------------------------------------------------------------------------------------------
\Screener\....................           \933\             \1\           \933\  \.08\ \(5                \74.64\
                                                                                minutes)\.
\Pretest\.....................            \25\             \1\            \25\  \0.33\ \(20               \8.25\
                                                                                minutes)\.
\Main test\...................           \368\             \1\           \368\  \0.33\ \(20             \121.44\
                                                                                minutes)\.
                               ---------------------------------------------------------------------------------
    \Total\...................  ..............  ..............  ..............  ................        \204.33\
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

III. References

    The following references marked with an asterisk (*) are on display
at the Dockets Management Staff (see ADDRESSES) and are available for
viewing by interested persons between 9 a.m. and 4 p.m., Monday through
Friday; they also are available electronically at https://www.regulations.gov. References without asterisks are not on public
display at https://www.regulations.gov because they have copyright
restriction. Some may be available at the website address, if listed.
References without asterisks are available for viewing only at the
Dockets Management Staff. FDA has verified the website addresses, as of
the date this document publishes in the Federal Register, but websites
are subject to change over time.

1. Mack, J. (March 2006). ``Effective Physician Marketing at Medical
Meeting Exhibits.'' Pharma Marketing News, 5(3).
2. *Industry Standard Report (2014). ``Pharmaceutical Detailing: In-
Person vs. Electronic vs. Phone.'' Retrieved from https://www.isrreports.com/wp-content/uploads/2014/08/ISR-Pharmaceutical-Detailing-In-Person-vs.-Electronic-vs.-Phone-Preview-Aug2014.pdf.
3. Steinman, M. A., G. M. Harper, M. M. Chren, et al (April 2007).
``Characteristics and Impact of Drug Detailing for Gabapentin.''
PLoS Med, 4(4), e134. http://dx.doi.org/10.1371/journal.pmed.0040134.
4. Adler, D., A. Sherman, and M. Walz (2017). ``Medical Conference
Presence: Is it Worth it for Your Brand?'' Retrieved from https://www.pharmavoice.com/article/2017-9-medical-conferences/.
5. *FDA. Warning letters and notice of violation letters to
pharmaceutical companies. Retrieved from https://www.fda.gov/drugs/enforcement-activities-fda/warning-letters-and-notice-violation-letters-pharmaceutical-companies.
6. Brock, T. C. (June 1965). ``Communicator-Recipient Similarity and
Decision Change.'' Journal of Personality & Social Psychology, 1,
650-654.
7. Braunsberger, K. and J. M. Munch (1998). ``Source Expertise
Versus Experience Effects in Hospital Advertising.'' Journal of
Services Marketing, 12(1), 23-38.
8. Siemens, J. C., S. Smith, D. Fisher, and T. D. Jensen, (2008).
``Product Expertise Versus Professional Expertise: Congruency
Between an Endorser's Chosen Profession and the Endorsed Product.''
Journal of Targeting, Measurement and Analysis for Marketing, 16(3),
159-168.
9. Pechmann, C. (1992). ``Predicting When Two-Sided Ads Will be More
Effective Than One-Sided Ads: The Role of Correlational and
Correspondent Inferences.'' Journal of Marketing Research, 29(4),
441-453.

    Dated: September 14, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-20614 Filed 9-17-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 82, Number 138 (Thursday, July 20, 2017)]
[Notices]
[Pages 33525-33526]
[FR Doc No: 2017-15197]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-81152; File No. SR-BatsBZX-2017-45]

Self-Regulatory Organizations; Bats BZX Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change to BZX
Rule 14.13, Company Listing Fees, To Amend the Fees Applicable to
Securities Listed on the Exchange

July 14, 2017.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on July 3, 2017, Bats BZX Exchange, Inc. (the ``Exchange'' or
``BZX'') filed with the Securities and Exchange Commission
(``Commission'') the 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 filed a proposed rule change to amend the fees
applicable to securities listed on the Exchange, which are set forth in
Exchange Rule 14.13. Changes to the Exchange's fees pursuant to this
proposal are effective upon filing.
    The text of the proposed rule change is available at the Exchange's
Web site at www.bats.com, at the principal office of the Exchange, 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 parts of such
statements.

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

1. Purpose
    On August 30, 2011, the Exchange received approval of rules
applicable to the qualification, listing, and delisting of companies on
the Exchange,\3\ which it modified on February 8, 2012 in order to
adopt pricing for the listing of exchange traded products (``ETPs'')
\4\ on the Exchange,\5\ which it subsequently modified again on June 4,
2014.\6\ On October 16, 2014, the Exchange modified Rule 14.13,
``Company Listing Fees,'' to eliminate the annual fees for ETPs not
participating in the Exchange's Competitive Liquidity Provider Program
pursuant to Rule 11.8, Interpretations and Policies .02 (the ``CLP
Program'').\7\ On May 22, 2015, the Exchange further modified Rule
14.13 to eliminate the application fee for ETPs, effectively
eliminating any compulsory fees for both new ETP issues and transfer
listings onto the Exchange.\8\ On September 30, 2015, the Exchange
began offering an incentive payment to ETPs that are listed on the
Exchange based on the consolidated average daily volume (the ``CADV'')
of the ETP (the ``Issuer Incentive Program'').\9\ The Exchange
subsequently made an administrative change to the Issuer Incentive
Program that required an issuer to enroll in order to receive
payment.\10\
---------------------------------------------------------------------------

    \3\ See Securities Exchange Act Release No. 65225 (August 30,
2011), 76 FR 55148 (September 6, 2011) (SR-BATS-2011-018).
    \4\ As defined in Exchange Rule 11.8(e)(1)(A), the term ``ETP''
means any security listed pursuant to Exchange Rule 14.11.
    \5\ See Securities Exchange Act Release No. 66422 (February 17,
2012), 77 FR 11179 (February 24, 2012) (SR-BATS-2012-010).
    \6\ See Securities Exchange Act Release No. 72377 (June 12,
2014), 79 FR 34822 (June 18, 2014) (SR-BATS-2014-024).
    \7\ See Securities Exchange Act Release No. 73414 (October 23,
2014), 79 FR 64434 (October 29, 2014) (SR-BATS-2014-050).
    \8\ See Securities Exchange Act Release No. 75085 (June 1,
2015), 80 FR 32190 (June 5, 2015) (SR-BATS-2015-39).
    \9\ See Securities Exchange Act Release No. 76113 (October 8,
2015), 80 FR 62142 (October 15, 2015) (SR-BATS-2015-80).
    \10\ See Securities Exchange Act Release No. 77960 (June 1,
2016), 81 FR 36632 (June 7, 2016) (SR-BatsBZX-2016-20).
---------------------------------------------------------------------------

    The Exchange submits this proposal to decommission the Issuer
Incentive Program. Currently, under Exchange Rule 14.13(b)(2)(C), the
issuer of each class of securities that is a domestic or foreign issue
listed on the Exchange as an ETP is eligible to receive payments from
the Exchange on a quarterly basis based on the CADV of the ETP for each
trading day of the preceding calendar

quarter that the ETP was listed on the Exchange. The annualized
payments range from the lowest bracket of $3,000 for CADV between 1-3
million shares to the highest bracket of $400,000 for CADV greater than
35 million shares. The Exchange is proposing to eliminate such
payments.
Implementation Date
    The Exchange proposes to implement the amendments to Rule
14.13(b)(2)(C) effective July 3, 2017.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the requirements of the Act and the rules and regulations
thereunder that are applicable to a national securities exchange, and,
in particular, with the requirements of Section 6 of the Act.\11\
Specifically, the Exchange believes that the proposed rule change is
consistent with Section 6(b)(4) and 6(b)(5) of the Act,\12\ in that it
provides for the equitable allocation of reasonable dues, fees and
other charges among issuers and is designed to promote just and
equitable principles of trade, to foster cooperation and coordination
with persons engaged in facilitating transactions in securities, to
remove impediments to and perfect the mechanism of a free and open
market and a national market system, and, in general, to protect
investors and the public interest, and are not designed to permit
unfair discrimination between customers, issuers, brokers, or dealers.
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78f.
    \12\ 15 U.S.C. 78f(b)(4) and (5).
---------------------------------------------------------------------------

    The Exchange is proposing to decommission the Issuer Incentive
Program, which established payments from the Exchange to ETP issuers
that list on the Exchange and achieve a particular CADV threshold. The
Exchange believes that the proposal is equitable, reasonable, and non-
discriminatory because decommissioning the Issuer Incentive Program
will affect all ETP issuers listing on the Exchange equally. The
Exchange also believes that the proposal to eliminate the Issuer
Incentive Program is reasonable, fair and equitable, and not an
unfairly discriminatory allocation of fees and other charges because it
would apply equally to all Issuers and eliminating the payment will
allow the Exchange to better allocate its resources in order to make it
a more attractive listing venue for ETPs. Additionally, the payments
under the Issuer Incentive Program have not had the impact that the
Exchange sought when it was implemented.
    Based on the foregoing, the Exchange believes that the proposed
amendment to Rule 14.13(b)(2)(C) to eliminate the Issuer Incentive
Program is a reasonable, equitable, and non-discriminatory allocation
of fees and other charges to issuers.

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

    The Exchange believes that the proposal would not impose any burden
on competition that is not necessary or appropriate in furtherance of
the purposes of the Act. The Exchange acknowledges that it operates in
a highly competitive environment, and that ETP issuers may opt to
disfavor listing on the Exchange if they believe that alternatives
offer them better value. Accordingly, the Exchange does not believe
that the proposed changes will impair the ability of ETP issuers or
competing venues to maintain their competitive standing in the
financial markets. The Exchange does not believe that the proposed
changes to the Exchange's standard fees, rebates and tiered pricing
structure burdens competition, but instead, enhances competition as it
is intended to increase the competitiveness of the Exchange.

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

    The Exchange has not solicited, and does not intend to solicit,
comments on this proposed rule change. The Exchange has not received
any written comments from members or other interested parties.

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) of the Act \13\ and paragraph (f) of Rule 19b-4
thereunder.\14\ 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.
---------------------------------------------------------------------------

    \13\ 15 U.S.C. 78s(b)(3)(A).
    \14\ 17 CFR 240.19b-4(f).
---------------------------------------------------------------------------

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views and
arguments concerning the foregoing, including whether the proposal 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_ADDRESS>Please include
File No. SR-BatsBZX-2017-45 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 No. SR-BatsBZX-2017-45. 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 Web site (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 Web site 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 will also be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File No. SR-BatsBZX-2017-45 and should be
submitted on or before August 10, 2017.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\15\
---------------------------------------------------------------------------

    \15\ 17 CFR 200.30-3(a)(12).
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Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2017-15197 Filed 7-19-17; 8:45 am]
 BILLING CODE 8011-01-P