lead, which was evaluated differently), the maximum Tier 1 SV was less
than or equal to 1 for all PB-HAP.
    For lead, we did not estimate any exceedances of the secondary lead
NAAQS. For HCl, the average modeled concentration around each facility
(i.e., the average concentration of all off-site data points in the
modeling domain) did not exceed any ecological benchmark. In addition,
for the one facility that reported HCl emissions, each individual
modeled concentration of HCl (i.e., each off-site data point in the
modeling domain) was below the ecological benchmarks for HCl.
    Based on the results of the environmental risk screening analysis,
we do not expect an adverse environmental effect as a result of HAP
emissions from this source category.
5. Facility-Wide Risk Results
    The EPA estimated inhalation risk based on facility-wide emissions.
The estimated maximum individual excess lifetime cancer risk based on
facility-wide emissions was 200-in-1 million, with 0.04 excess cancer
cases per year, or one case every 25 years. This cancer risk is driven
by emissions sources that are not in the Cyanide Chemicals
Manufacturing source category; specifically, emissions of ethylene
oxide and coke oven emissions from non-category sources account for 95
percent of the cancer incidence. Approximately 150 people are exposed
to an excess cancer risk greater than or equal to 100-in-1 million,
with 266,532 people exposed to an excess cancer risk above 1-in-1
million (see Table 1 of this preamble). The estimated maximum chronic
noncancer TOSHI values for the facility-wide assessment was the same as
estimated based on actual and allowable emissions from the source
category--a TOSHI equal to 1 for neurological effects driven by
hydrogen cyanide emissions from process vents, wastewater, and
equipment leaks.
    Regarding the facility-wide risks due to ethylene oxide, which are
emitted by sources that are not part of the Cyanide Chemicals
Manufacturing source category, we intend to continue to evaluate those
facility-wide estimated emissions and risks further and may address
these in separate actions, as appropriate. In particular, the EPA is
addressing ethylene oxide in response to the results of the latest NATA
released in August 2018, which identified the chemical as a potential
concern in several areas across the country (NATA is the Agency's
nationwide air toxics screening tool, designed to help the EPA and
state, local, and tribal air agencies identify areas, pollutants, or
types of sources for

further examination). The latest NATA estimates that ethylene oxide
significantly contributes to potential elevated cancer risks in some
census tracts across the U.S. (less than 1 percent of the total number
of tracts). These elevated risks are largely driven by an EPA risk
value that was updated in late 2016. The EPA will work with industry
and state, local, and tribal air agencies as the EPA takes a two-
pronged approach to address ethylene oxide emissions by: (1) Reviewing
and, as appropriate, revising CAA regulations for facilities that emit
ethylene oxide--starting with air toxics emissions standards for
miscellaneous organic chemical manufacturing facilities (85 FR 49084,
August 12, 2020) and commercial sterilizers; and (2) conducting site-
specific risk assessments and, as necessary, implementing emission
control strategies for targeted high-risk facilities. The EPA will post
updates on its work to address ethylene oxide on its website at:
https://www.epa.gov/ethylene-oxide.
6. What demographic groups might benefit from this regulation?
    To examine the potential for any environmental justice issues that
might be associated with the source category, we performed a
demographic analysis, which is an assessment of risk to individual
demographic groups of the populations living within 5 km and within 50
km of the facilities. In the analysis, we evaluated the distribution of
HAP-related cancer and noncancer risk from the Cyanide Chemicals
Manufacturing source category across different demographic groups
within the populations living near facilities.\24\
---------------------------------------------------------------------------

    \24\ Demographic groups included in the analysis are: White,
African American, Native American, other races and multiracial,
Hispanic or Latino, children 17 years of age and under, adults 18 to
64 years of age, adults 65 years of age and over, adults without a
high school diploma, people living below the poverty level, people
living two times the poverty level, and linguistically isolated
people.
---------------------------------------------------------------------------

    The results of the demographic analysis are summarized in Table 2
below. These results, for various demographic groups, are based on the
estimated risk from actual emissions levels for the population living
within 50 km of the facilities.

                   TABLE 2--Cyanide Chemicals Manufacturing Demographic Risk Analysis Results
----------------------------------------------------------------------------------------------------------------
                                                                                Population
                                                                                with cancer     Population
                                                                                risk at or     with chronic
                                                                                above 1-in-1   HI above 1 due
                                                                    Nationwide    million due to    to cyanide
                                                                                cyanide        chemicals
                                                                                chemicals     manufacturing
                                                                                manufacturing
----------------------------------------------------------------------------------------------------------------
Total Population................................................     317,746,049          61,653               0
----------------------------------------------------------------------------------------------------------------
                                                 Race by Percent
----------------------------------------------------------------------------------------------------------------
White...........................................................              62              73  ..............
All Other Races.................................................              38              27  ..............
----------------------------------------------------------------------------------------------------------------
                                                 Race by Percent
----------------------------------------------------------------------------------------------------------------
White...........................................................              62              73  ..............
African American................................................              12              19  ..............
Native American.................................................             0.8             0.4  ..............
Other and Multiracial...........................................               7               4  ..............
----------------------------------------------------------------------------------------------------------------
                                              Ethnicity by Percent
----------------------------------------------------------------------------------------------------------------
Hispanic........................................................              18               3  ..............
Non-Hispanic....................................................              82              97  ..............
----------------------------------------------------------------------------------------------------------------
                                                Income by Percent
----------------------------------------------------------------------------------------------------------------
Below Poverty Level.............................................              14              16  ..............
Above Poverty Level.............................................              86              84  ..............
----------------------------------------------------------------------------------------------------------------
                                              Education by Percent
----------------------------------------------------------------------------------------------------------------
Over 25 and without High School Diploma.........................              14              16  ..............
Over 25 and with a High School Diploma..........................              86              84  ..............
----------------------------------------------------------------------------------------------------------------

    The results of the Cyanide Chemicals Manufacturing source category
demographic analysis indicate that emissions from the source category
expose approximately 61,653 people to a cancer risk at or above 1-in-1
million and nobody to a chronic noncancer TOSHI greater than 1. The
percentages of the at-risk population in the White, African American,
Below Poverty, and Over 25 without High School Diploma demographic
groups are greater than their respective nationwide percentages.
    The methodology and the results of the demographic analysis are
presented in a technical report, Risk and Technology Review--Analysis
of Demographic Factors for Populations Living Near Cyanide Chemicals
Manufacturing, available in the docket for this action.

C. What are our proposed decisions regarding risk acceptability, ample
margin of safety, and adverse environmental effect?

1. Risk Acceptability
    As explained in section II.A of this preamble, the EPA sets
standards under

CAA section 112(f)(2) using ``a two-step standard-setting approach,
with an analytical first step to determine an 'acceptable risk' that
considers all health information, including risk estimation
uncertainty, and includes a presumptive limit on maximum individual
risk (MIR) of approximately 1-in-10 thousand.'' (54 FR 38045, September
14, 1989). The EPA weighed all health risk measures and information,
including science policy assumptions and estimation uncertainties, in
determining whether risk posed by emissions from the source category is
acceptable.
    The estimated maximum cancer risk for inhalation exposure to actual
and allowable emissions from the Cyanide Chemicals Manufacturing source
category was 5-in-1 million, 20 times below 100-in-1 million, which is
the presumptive upper limit of acceptable risk. The EPA estimates
emissions from the category would result in a cancer incidence of 0.004
excess cancer cases per year, or one case every 250 years. Inhalation
exposures to HAP associated with chronic noncancer health effects
result in a TOSHI of 1 based on actual and allowable emissions, an
exposure level that the EPA has determined is without appreciable risk
of adverse health effects. Exposures to HAP associated with acute
noncancer health effects also are below levels of health concern with
no HAP exposures resulting in an HQ greater than 1 based upon the 1-
hour REL.
    Maximum cancer risk due to ingestion exposures, estimated using
health-protective risk screening assumptions, is below 1-in-1 million
for the Tier 2 farmer exposure scenario. Tier 2 screening analyses of
mercury exposure due to fish ingestion determined that the maximum HQ
for mercury would be less than 1 as explained in section III.C.4 of
this preamble.
    Considering all of the health risk information and factors
discussed above, as well as the uncertainties discussed in section III
of this preamble, we propose that the risks posed by emissions from the
Cyanide Chemicals Manufacturing source category are acceptable.
2. Ample Margin of Safety Analysis
    As directed by CAA section 112(f)(2), we conducted an analysis to
determine whether the current emissions standards provide an ample
margin of safety to protect public health. Under the ample margin of
safety analysis, we evaluated the cost and feasibility of available
control technologies and other measures (including the controls,
measures, and costs reviewed under the technology review) that could be
applied to this source category to further reduce the risks (or
potential risks) due to emissions of HAP from the source category. In
light of the low cancer and noncancer risk posed to individuals exposed
to HAP emitted from this source category and lack of additional control
technologies, we are proposing to conclude that the existing standards
under the NESHAP provide an ample margin of safety to protect public
health.
3. Adverse Environmental Effect
    Based on the results of our environmental risk screening analysis,
we do not anticipate an adverse environmental effect as a result of HAP
emissions from this source category. Therefore, the EPA is proposing
that it is not necessary to set a more stringent standard to prevent,
taking into consideration costs, energy, safety, and other relevant
factors, an adverse environmental effect.

D. What are the results and proposed decisions based on our technology
review?

    As part of the technology review, we identified a previously
unregulated process, and are proposing a MACT standard for the process
under CAA section 112(d)(2) and (3), as described in Section IV.A of
this preamble, above. We did not identify any developments in
processes, practices, or control technologies for cyanide chemicals
manufacturing facilities during our analysis for this proposal.
Facilities subject to this NESHAP use flares to control emissions from
point sources and LDAR programs to address emissions from equipment
leaks. As discussed in the memorandum titled Technical Support Document
for the Cyanide Chemicals Manufacturing NESHAP Residual Risk and
Technology Review Proposal, we did not identify any developments in
these technologies during our technology review.

E. What other actions are we proposing?

    In addition to the proposed actions described above, we are
proposing additional revisions to the NESHAP. We are proposing
revisions to the SSM provisions of the MACT rule in order to ensure
that they are consistent with the decision in Sierra Club v. EPA, 551
F. 3d 1019 (DC Cir. 2008), in which the court vacated two provisions
that exempted sources from the requirement to comply with otherwise
applicable CAA section 112(d) emission standards during periods of SSM.
We note that for the Cyanide Chemicals Manufacturing source category,
the NESHAP currently does not include an exemption for SSM events, and
already includes standards that apply at all times, including periods
of SSM. Therefore, we have determined that the NESHAP is already
consistent with the court decision mentioned above. However, we are
making revisions to the MACT rule at 40 CFR 63.1108 through 40 CFR
63.1112 to ensure this is clearly and consistently communicated
throughout and no confusion results from referenced subparts associated
with the GMACT that may contain SSM exemptions for other source
categories. We also are proposing other changes to add electronic
reporting. Our analyses and proposed changes related to these issues
are discussed below.
    Electronic Reporting. The EPA is proposing that owners and
operators of cyanide chemicals manufacturing facilities submit
electronic copies of required notifications of compliance, performance
test reports, and periodic reports through the EPA's Central Data
Exchange (CDX) using the Compliance and Emissions Data Reporting
Interface (CEDRI). A description of the electronic data submission
process is provided in the memorandum, Electronic Reporting
Requirements for New Source Performance Standards (NSPS) and National
Emission Standards for Hazardous Air Pollutants (NESHAP) Rules,
available in the docket for this action. The proposed rule requires
that performance test results collected using test methods that are
supported by the EPA's Electronic Reporting Tool (ERT) as listed on the
ERT website \25\ at the time of the test be submitted in the format
generated through the use of the ERT or an electronic file consistent
with the xml schema on the ERT website, and other performance test
results be submitted in portable document format (PDF) using the
attachment module of the ERT. The proposed rule requires that
Notification of Compliance Status (NOCS) be submitted as a PDF upload
in CEDRI.
---------------------------------------------------------------------------

    \25\ https://www.epa.gov/electronic-reporting-air-emissions/electronic-reporting-tool-ert.
---------------------------------------------------------------------------

    For periodic reports, the proposed rule requires that owners and
operators use the appropriate spreadsheet template to submit
information to CEDRI. A draft version of the proposed template for
these reports is included in the docket for this action.\26\ The EPA
specifically requests comment on the content, layout, and overall
design of the template.
---------------------------------------------------------------------------

    \26\ See Draft Form_5900-
485_Subpart_YY_Cyanide_Draft_Periodic_Report_Template_Proposal.xlsm,
available at Docket ID No. EPA-HQ-OAR-2020-0532.
---------------------------------------------------------------------------

    Additionally, the EPA has identified two broad circumstances in
which

electronic reporting extensions may be provided. These circumstances
are (1) outages of the EPA's CDX or CEDRI which preclude an owner or
operator from accessing the system and submitting required reports and
(2) force majeure events, which are defined as events that will be or
have been caused by circumstances beyond the control of the affected
facility, its contractors, or any entity controlled by the affected
facility that prevent an owner or operator from complying with the
requirement to submit a report electronically. Examples of force
majeure events are acts of nature, acts of war or terrorism, or
equipment failure or safety hazards beyond the control of the facility.
The EPA is providing these potential extensions to protect owners and
operators from noncompliance in cases where they cannot successfully
submit a report by the reporting deadline for reasons outside of their
control. In both circumstances, the decision to accept the claim of
needing additional time to report is within the discretion of the
Administrator, and reporting should occur as soon as possible.
    The electronic submittal of the reports addressed in this proposed
rulemaking will increase the usefulness of the data contained in those
reports, is in keeping with current trends in data availability and
transparency, will further assist in the protection of public health
and the environment, will improve compliance by facilitating the
ability of regulated facilities to demonstrate compliance with
requirements and by facilitating the ability of delegated state, local,
tribal, and territorial air agencies and the EPA to assess and
determine compliance, and will ultimately reduce burden on regulated
facilities, delegated air agencies, and the EPA. Electronic reporting
also eliminates paper-based, manual processes, thereby saving time and
resources, simplifying data entry, eliminating redundancies, minimizing
data reporting errors, and providing data quickly and accurately to the
affected facilities, air agencies, the EPA, and the public. Moreover,
electronic reporting is consistent with the EPA's plan \27\ to
implement Executive Order 13563 and is in keeping with the EPA's
Agency-wide policy \28\ developed in response to the White House's
Digital Government Strategy.\29\ For more information on the benefits
of electronic reporting, see the memorandum, Electronic Reporting
Requirements for New Source Performance Standards (NSPS) and National
Emission Standards for Hazardous Air Pollutants (NESHAP) Rules,
referenced earlier in this section.
---------------------------------------------------------------------------

    \27\ EPA's Final Plan for Periodic Retrospective Reviews, August
2011. Available at: https://www.regulations.gov/document?D=EPA-HQ-OA-2011-0156-0154.
    \28\ E-Reporting Policy Statement for EPA Regulations, September
2013. Available at: https://www.epa.gov/sites/production/files/2016-03/documents/epa-ereporting-policy-statement-2013-09-30.pdf.
    \29\ Digital Government: Building a 21st Century Platform to
Better Serve the American People, May 2012. Available at: https://obamawhitehouse.archives.gov/sites/default/files/omb/egov/digital-government/digital-government.html.
---------------------------------------------------------------------------

F. What compliance dates are we proposing?

    The EPA is proposing that existing affected sources and affected
sources that commenced construction or reconstruction on or before
January 15, 2021, must comply with the proposed process wastewater
standards no later than 365 days after the effective date of the final
rule and all of the other amendments no later than 180 days after the
effective date of the final rule. The final action is not expected to
be a ``major rule'' as defined by 5 U.S.C. 804(2), so the effective
date of the final rule will be the promulgation date as specified in
CAA section 112(d)(10). For existing sources, we are proposing a change
that would impact ongoing compliance requirements for 40 CFR part 63,
subpart YY. As discussed elsewhere in this preamble, we are proposing
to change the requirements for SSM by removing references to exemptions
in other subparts. Our experience with similar industries shows that
this sort of regulated facility generally requires a time period of 180
days to read and understand the amended rule requirements; to evaluate
their operations to ensure that they can meet the standards during
periods of startup and shutdown as defined in the rule and make any
necessary adjustments; and to update their operations to reflect the
revised requirements.
    From our assessment of the timeframe needed for compliance with the
revised requirements, the EPA considers a period of 180 days to be the
most expeditious compliance period practicable, and, thus, is proposing
that existing affected sources be in compliance with this regulation's
revised requirements within 180 days of the regulation's effective
date. We solicit comment on this proposed compliance period, and we
specifically request submission of information from sources in this
source category regarding specific actions that would need to be
undertaken to comply with the proposed amended requirements, including
the proposed amendments related to recordkeeping and reporting and the
time needed to make the adjustments for compliance with them. We note
that information provided may result in changes to the proposed
compliance date; however, we expect the proposed compliance time to be
sufficient given that cyanide chemicals manufacturing facilities are
already subject to standards during these periods. We are proposing
that facilities will have 1 year to comply with the proposed process
wastewater standards for existing sources. We note that we do not
expect the proposed wastewater standards for existing sources to
require installation of any additional controls. We believe that all
affected sources are already complying with the proposed wastewater
requirements or requirements that are substantively identical. We are
proposing that facilities must comply within 365 days in order to
provide time to evaluate wastewater operations, perform compliance
calculations, and adjust plans and reports as necessary. We are seeking
comment on the assumption that facilities will not need to install
additional add-on controls and whether facilities would require more or
less time to comply with the proposed process wastewater requirements.
Affected sources that commence construction or reconstruction after
January 15, 2021, must comply with all requirements of the subpart,
including the amendments being proposed, no later than the effective
date of the final rule or upon startup, whichever is later. All
affected facilities would have to continue to meet the current
requirements of 40 CFR part 63, subpart YY, until the applicable
compliance date of the amended rule.

V. Summary of Cost, Environmental, and Economic Impacts

A. What are the affected sources?

    There are 13 cyanide chemicals manufacturing facilities currently
operating as major sources of HAP subject to the proposed amendments. A
list of facilities that are currently subject to the MACT standards is
available in the memorandum titled Technical Support Document for the
Cyanide Chemicals Manufacturing NESHAP Residual Risk and Technology
Review Proposal, available in Docket ID No. EPA-HQ-OAR-2020-0532.

B. What are the air quality impacts?

    We do not anticipate that the proposed amendments to this subpart
will impact air quality. We are not proposing changes to the standard
that

will result in additional emission reductions beyond the levels already
achieved by the NESHAP.

C. What are the cost impacts?

    The proposed amendments will have a limited cost impact on affected
facilities. Total estimated costs are $47,527 based on a $3,656 per
facility cost for all 13 facilities. The costs result from reading and
understanding rule requirements and adjusting compliance plans based on
the rule proposal. All costs are one-time expenses expected to occur in
the first year after the rule is finalized. Costs are based on Agency
knowledge and experience with the NESHAP program, related ICRs, and
Bureau of Labor Statistics data.

D. What are the economic impacts?

    Economic impact analyses focus on changes in market prices and
output levels. If changes in market prices and output levels in the
primary markets are significant enough, impacts on other markets may
also be examined. Both the magnitude of costs associated with the
proposed requirements and the distribution of these costs among
affected facilities can have a role in determining how the market will
change in response to a proposed rule.
    Economic costs to owners of cyanide chemicals manufacturing
facilities were measured in present value (PV) total costs and
equivalent annual value (EAV) costs. All cyanide chemicals
manufacturing facilities were estimated to have similar costs. All
costs are presented in 2019 dollars. See section V.C of this preamble
for additional information on costs.
    PV total costs and EAV costs were measured at the 3 percent and 7
percent discount rates. The duration of analysis was 8 years. Per
facility PV total cost estimate is $3,656 at the 3 percent and 7
percent discount rates. The similarity in both discount rates is due to
the costs all occuring in the first year after the rule is finalized.
EAV costs per facility are measured to be $521 and $612 at the 3
percent and 7 percent discount rates, respectively. Combined total PV
cost of the proposed requirements for all facilities is measured to be
$47,527 at the 3 percent and 7 percent discount rates. The similarity
in both discount rates is due to the costs all coming in the first year
that the rule will be finalized. Combined EAV costs of the proposed
requirements for all facilities are measured to be $6,771 and $7,959 at
the 3 percent and 7 percent discount rates, respectively.
    As required by the Regulatory Flexibility Act (RFA), we performed
an analysis to determine if any small entities would be unduly burdened
by the proposed amendments. We determined that all facilities subject
to the NESHAP are owned by large parent entities based on Small
Business Administration standards. No significant economic impacts from
the proposed amendments are anticipated because the PV and EAV costs
associated with the proposed revisions are minimal.

E. What are the benefits?

    As discussed in section V.B of this preamble, we do not anticipate
the proposed amendments to this subpart to impact air quality. The
electronic submittal of the reports addressed in this proposed
rulemaking will increase the usefulness of the data contained in those
reports, is in keeping with current trends in data availability and
transparency, will further assist in the protection of public health
and the environment, will improve compliance by facilitating the
ability of regulated facilities to demonstrate compliance with
requirements, and by facilitating the ability of delegated state,
local, tribal, and territorial air agencies and the EPA to assess and
determine compliance, and will ultimately reduce burden on regulated
facilities, delegated air agencies, and the EPA. Electronic reporting
also eliminates paper-based, manual processes, thereby saving time and
resources, simplifying data entry, eliminating redundancies, minimizing
data reporting errors, and providing data quickly and accurately to the
affected facilities, air agencies, the EPA, and the public.

VI. Request for Comments

    We solicit comments on this proposed action. In addition to general
comments on this proposed action, we are also interested in additional
data that may improve the risk assessments and other analyses. We are
specifically interested in receiving any improvements to the data used
in the site-specific emissions profiles used for risk modeling. Such
data should include supporting documentation in sufficient detail to
allow characterization of the quality and representativeness of the
data or information. Section VII of this preamble provides more
information on submitting data.

VII. Submitting Data Corrections

    The site-specific emissions profiles used in the source category
risk and demographic analyses and instructions are available for
download on the RTR website at https://www.epa.gov/stationary-sources-air-pollution/acetal-resins-acrylic-modacrylic-fibers-carbon-black-hydrogen. The data files include detailed information for each HAP
emissions release point for the facilities in the source category.
    If you believe that the data are not representative or are
inaccurate, please identify the data in question, provide your reason
for concern, and provide any ``improved'' data that you have, if
available. When you submit data, we request that you provide
documentation of the basis for the revised values to support your
suggested changes. To submit comments on the data downloaded from the
RTR website, complete the following steps:
    1. Within this downloaded file, enter suggested revisions to the
data fields appropriate for that information.
    2. Fill in the commenter information fields for each suggested
revision (i.e., commenter name, commenter organization, commenter email
address, commenter phone number, and revision comments).
    3. Gather documentation for any suggested emissions revisions
(e.g., performance test reports, material balance calculations).
    4. Send the entire downloaded file with suggested revisions in
Microsoft[supreg] Access format and all accompanying documentation to
Docket ID No. EPA-HQ-OAR-2020-0532 (through the method described in the
ADDRESSES section of this preamble).
    5. If you are providing comments on a single facility or multiple
facilities, you need only submit one file for all facilities. The file
should contain all suggested changes for all sources at that facility
(or facilities). We request that all data revision comments be
submitted in the form of updated Microsoft[supreg] Excel files that are
generated by the Microsoft[supreg] Access file. These files are
provided on the project website at https://www.epa.gov/stationary-sources-air-pollution/acetal-resins-acrylic-modacrylic-fibers-carbon-black-hydrogen.

VIII. Statutory and Executive Order Reviews

    Additional information about these statutes and Executive Orders
can be found at https://www.epa.gov/laws-regulations/laws-and-executive-orders.

A. Executive Orders 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulation and Regulatory Review

    This action is not a significant regulatory action and was,
therefore, not submitted to OMB for review.

B. Executive Order 13771: Reducing Regulations and Controlling
Regulatory Costs

    This action is not expected to be an Executive Order 13771
regulatory action because this action is not significant under
Executive Order 12866.

C. Paperwork Reduction Act (PRA)

    The information collection activities in this proposed rule have
been submitted to the OMB under the PRA. The Information Collection
Request (ICR) document that the EPA prepared has been assigned EPA ICR
number 2678.01. You can find a copy of the ICR in the docket for this
rule, and it is briefly summarized here.
    The EPA is proposing amendments that revise provisions pertaining
to emissions during periods of SSM, add requirements for electronic
reporting of NOCS, periodic reports, and performance test results, and
make other minor clarifications and corrections. This information will
be collected to assure compliance with the Cyanide Chemicals
Manufacturing NESHAP.
    Respondents/affected entities: Owners or operators of cyanide
chemicals manufacturing facilities.
    Respondent's obligation to respond: Mandatory (40 CFR part 63,
subpart YY).
    Estimated number of respondents: 13 (assumes no new respondents
over the next 3 years).
    Frequency of response: Initially, occasionally, and annually.
    Total estimated burden: 160 hours (per year) to comply with all of
the requirements in the NESHAP. Burden is defined at 5 CFR 1320.3(b).
    Total estimated cost: $15,800 (per year), including no annualized
capital or operation and maintenance costs, to comply with all of the
requirements in the NESHAP.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid OMB control number. The OMB control numbers for the
EPA's regulations in 40 CFR are listed in 40 CFR part 9.
    Submit your comments on the Agency's need for this information, the
accuracy of the provided burden estimates, and any suggested methods
for minimizing respondent burden to the EPA using the docket identified
at the beginning of this rule. You may also send your ICR-related
comments to OMB's Office of Information and Regulatory Affairs via
email to<EMAIL_ADDRESS>Attention: Desk Officer for the
EPA. Since OMB is required to make a decision concerning the ICR
between 30 and 60 days after receipt, OMB must receive comments no
later than February 16, 2021. The EPA will respond to any ICR-related
comments in the final rule.

D. Regulatory Flexibility Act (RFA)

    I certify that this action will not have a significant economic
impact on a substantial number of small entities under the RFA. This
action will not impose any requirements on small entities. There are no
small entities among the eight ultimate parent companies impacted by
this proposed action given the Small Business Administration small
business size definition for this industry (1,000 employees or greater
for NAICS 325180--Other Basic Inorganic Chemical Manufacturing), and no
significant economic impact on any of these entities.

E. Unfunded Mandates Reform Act (UMRA)

    This action does not contain an unfunded mandate of $100 million or
more as described in UMRA, 2 U.S.C. 1531-1538, and does not
significantly or uniquely affect small governments. The action imposes
no enforceable duty on any state, local, or tribal governments or the
private sector.

F. Executive Order 13132: Federalism

    This action does not have federalism implications. It will 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.

G. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    This action does not have tribal implications as specified in
Executive Order 13175. None of the cyanide chemicals manufacturing
production facilities that have been identified as being affected by
this proposed action are owned or operated by tribal governments or
located within tribal lands. Thus, Executive Order 13175 does not apply
to this action.

H. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks

    This action is not subject to Executive Order 13045 because the EPA
does not believe the environmental health risks or safety risks
addressed by this action present a disproportionate risk to children.
This action's health and risk assessments are contained in section IV.B
of this preamble and the document, Residual Risk Assessment for the
Cyanide Chemicals Manufacturing Source Category in Support of the Risk
and Technology Review 2020 Proposed Rule, which is available in the
docket for this rulemaking.

I. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use

    This action is not subject to Executive Order 13211, because it is
not a significant regulatory action under Executive Order 12866.

J. National Technology Transfer and Advancement Act (NTTAA)

    This action involves technical standards. Therefore, the EPA
conducted a search to identify potentially applicable voluntary
consensus standards. However, the Agency identified no such standards.
A thorough summary of the search and results are included in the
memorandum titled Voluntary Consensus Standard Results for Cyanide
Chemicals Manufacturing Residual Risk and Technology Review, which is
available in the docket for this action.

K. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations

    The EPA believes that this action does not have disproportionately
high and adverse human health or environmental effects on minority
populations, low-income populations, and/or indigenous peoples, as
specified in Executive Order 12898 (59 FR 7629, February 16, 1994).
    The documentation for this decision is contained in section IV.B of
this preamble and in the technical report, Risk and Technology Review--
Analysis of Demographic Factors for Populations Living Near Cyanide
Chemicals Manufacturing Facilities, available in the docket for this
action.

List of Subjects in 40 CFR Part 63

    Environmental protection, Air pollution control, Hazardous
substances, Reporting and recordkeeping requirements.

Andrew Wheeler,
Administrator.
[FR Doc. 2021-00374 Filed 1-14-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 75, Number 92 (Thursday, May 13, 2010)]
[Notices]
[Pages 27034-27036]
[FR Doc No: 2010-11398]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-62051; File No. SR-ISE-2010-38]

Self-Regulatory Organizations; International Securities Exchange,
LLC; Notice of Filing and Order Granting Accelerated Approval to a
Proposed Rule Change Relating to the Amounts That Direct Edge ECN, in
Its Capacity as an Introducing Broker for Non-ISE Members, Passes
Through to Such Non-ISE Members

May 6, 2010.
    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 April 30, 2010, the International Securities Exchange, LLC (the
``Exchange'' or the ``ISE'') filed with the Securities and Exchange
Commission (``Commission'') the proposed rule change as described in
Items I and II below, which Items have been prepared by the self-
regulatory organization. The Commission is publishing this notice to
solicit comments on the proposed rule change from interested persons,
and is approving the proposal on an accelerated basis.
---------------------------------------------------------------------------

    \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 proposes to modify the amounts that Direct Edge ECN
(``DECN''), in its capacity as an introducing broker for non-ISE
Members, passes through to such non-ISE Members.
    The text of the proposed rule change is available on the Exchange's
Internet website at http://www.ise.com.

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 self-regulatory organization
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 III below. The self-regulatory
organization has prepared summaries, set forth in sections A, B and C
below, of the most significant aspects of such statements.

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

1. Purpose
    DECN, a facility of ISE, operates two trading platforms, EDGX and
EDGA.\3\ The changes made pursuant to SR-ISE-2010-37 became operative
on May 1, 2010. On April 30, 2010, the ISE filed for immediate
effectiveness a proposed rule change to amend Direct Edge ECN's
(``DECN'') fee schedule for ISE Members \4\ to: (i) Change the rates
for

routing in securities priced less than $1.00 to certain away market
centers; \5\ (ii) reintroduce the rebate on securities priced less than
$1.00 that add liquidity to EDGX; \6\ (iii) increase the rebate for
Members meeting the Ultra Tier; \7\ and (iv) pass through rebates/fees
from other market centers.\8\ The changes made pursuant to SR-ISE-2010-
37 became operative on May 1, 2010.
---------------------------------------------------------------------------

    \3\ This fee filing relates to the trading facility operated by
ISE and not EDGA Exchange, Inc. and EDGX Exchange, Inc. Direct Edge
ECN LLC (EDGA and EDGX) will cease to operate in its capacity as an
electronic communications network following the commencement of
operations of EDGA Exchange, Inc. and EDGX Exchange, Inc. as
national securities exchanges.
    \4\ References to ISE Members in this filing refer to DECN
Subscribers who are ISE Members.
    \5\ In SR-ISE-2010-37, the Exchange amended the routing rates to
certain away market centers associated with the removal of liquidity
from EDGA and EDGX in securities priced less than $1.00. For orders
in securities priced less than $1.00 that are routed to Nasdaq BX in
Tapes A & C securities and that remove liquidity, orders were
charged the Exchange's standard routing charge for securities less
than $1.00 (0.30% of the total dollar value of the transaction, both
on EDGA and EDGX). As a result of a decrease in fees by Nasdaq OMX
when removing liquidity in securities priced less than $1.00, the
Exchange amended its fee schedule in order to charge 0.10% of the
total dollar value of the transaction (instead of 0.30%) when orders
were routed to Nasdaq BX in Tapes A & C securities and removed
liquidity. This has been indicated by footnote number 3 on the
existing ``C'' flag. A conforming amendment has also been made to
the fee schedule to append footnote number 3 to indicate an
exception to the standard rate (0.30% of dollar value) for routing
liquidity in securities priced less than $1.00. See Nasdaq OMX
Equity Trader Alert, 2010-27 (April 19, 2010) (``Firms will
be charged 0.10% (i.e., 10 basis points) of the total dollar value
of the transaction when removing liquidity in stocks with prices
below $1.00'').
     Additionally, in SR-ISE-2010-37, the Exchange amended its fee
schedule to charge 0.20% of the total dollar value of the
transaction when orders are routed to Nasdaq and remove liquidity in
securities on all Tapes, or orders are routed to Nasdaq using the
INET order type and remove liquidity in securities on all Tapes.
(The INET order type sweeps the EDGA or EDGX book and removes
liquidity from Nasdaq, if the order is marketable, or posts on
Nasdaq, if the order is non-marketable.) This has been indicated by
footnote number 3 being appended to the existing ``J,'' ``L,'' and
``2'' flags. A conforming amendment has also been made to the fee
schedule to append footnote number 3 to indicate an exception to the
standard rate (0.30% of dollar value) for routing liquidity in
securities priced less than $1.00.
     The Exchange believes that this rate change will seek to
incentivize the removal of liquidity from EDGA and EDGX in
securities priced less than $1.00 that are routed to certain away
market centers.
    \6\ There was no rebate for adding liquidity on EDGX in
securities priced less than $1.00. In SR-ISE-2010-37, the Exchange
re-introduced a rebate of $0.00003 per share for orders that add
liquidity to EDGX in securities priced less than $1.00. The Exchange
believes that this rebate was appropriate as it represented 30% of
the minimum price increment for securities priced less than $1.00
($0.0001) and effectively aligned the rebate with access fee caps
under Regulation NMS. The Access Rule of Regulation NMS limits the
fees any trading center can charge, or allow to be charged, for
accessing its protected quotations, both displayed and reserve size,
to no more than $0.003 per share. See Rule 610(c) of Regulation NMS,
Securities and Exchange Act Release No. 51808 (June 9, 2005), 70 FR
37496 (June 29, 2005).
    \7\ The Exchange's fee schedule provided Members can qualify for
a rebate of $0.0031 per share for all liquidity posted on EDGX if
they add or route at least 5,000,000 shares of average daily volume
prior to 9:30 a.m. or after 4 p.m. (includes all flags except 6) and
add a minimum of 50,000,000 shares of average daily volume on EDGX
in total, including during both market hours and pre and post-
trading hours. In SR-ISE-2010-37, effective May 1, 2010, the
Exchange increased this rebate to $0.0032 per share to further
incentivize posting liquidity to EDGX. In addition, the higher
rebate also resulted, in part, from lower administrative costs
associated with higher volume.
    \8\ The NYSE recently announced changes, effective May 2010,
that it will increase the fee for removing liquidity in Tape A
securities to $0.0021 per share (from 0.0018 per share) and increase
the rebate for trading in Tape A securities to $0.0013 per share
(from $0.0010 per share). In SR-ISE-2010-37, Flag D, which indicates
orders that are routed or re-routed to NYSE, and remove liquidity,
was amended to reflect the charge of $0.0021 per share. A conforming
amendment was also made to Flag F (routed to NYSE, adds liquidity)
to increase the rebate to $0.0013 per share. Footnote 3 was amended
to reflect NYSE's fee change for trading in securities with a per
share price below $1.00 (from $0.0018 per share to $0.0021 per
share). In addition, the ``Q'' flag, which denotes an order type
(ROUC) that routes to the NYSE, was increased from $0.0015 per share
to $0.0018 per share on EDGA and EDGX to reflect the increase.
---------------------------------------------------------------------------

    In its capacity as a member of ISE, DECN currently serves as an
introducing broker for the non-ISE Member subscribers of DECN to access
EDGX and EDGA. DECN, as an ISE Member and introducing broker, receives
rebates and is assessed charges from DECN for transactions it executes
on EDGX or EDGA in its capacity as introducing broker for non-ISE
Members. Since the amounts of such rebates and charges were changed
pursuant to SR-ISE-2010-37, DECN wishes to make corresponding changes
to the amounts it passes through to non-ISE Member subscribers of DECN
for which it acts as introducing broker. As a result, the per share
amounts that non-ISE Member subscribers receive and are charged will be
the same as the amounts that ISE Members receive and are charged.
    ISE is seeking accelerated approval of this proposed rule change,
as well as an effective date of May 1, 2010. ISE represents that this
proposal will ensure that both ISE Members and non-ISE Members (by
virtue of the pass-through described above) will in effect receive and
be charged equivalent amounts and that the imposition of such amounts
will begin on the same May 1, 2010 start date.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the objectives of Section 6 of the Act,\9\ in general, and
furthers the objectives of Section 6(b)(4),\10\ in particular, in that
it is designed to provide for the equitable allocation of reasonable
dues, fees and other charges among its members and other persons using
its facilities. In particular, this proposal will ensure that dues,
fees and other charges imposed on ISE Members are equitably allocated
to both ISE Members and non-ISE Members (by virtue of the pass-through
described above).
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78f.
    \10\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

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

    The proposed rule change does not impose any burden on competition
that is not necessary or appropriate in furtherance of the purposes of
the Act.

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 unsolicited written comments from members or other interested
parties.

III. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-ISE-2010-38 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-ISE-2010-38. This file
number should be included on the subject line if e-mail 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,\11\ 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 a.m. and 3 p.m. Copies of the
filing also will be available for inspection and copying at the
principal office of the ISE. 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 Number SR-ISE-2010-38 and should be submitted on or before June 3,
2010.
---------------------------------------------------------------------------

    \11\ The text of the proposed rule change is available on ISE's
Web site at http://www.ise.com, on the Commission's Web site at
http://www.sec.gov, at ISE, and at the Commission's Public Reference
Room.
---------------------------------------------------------------------------

IV. Commission's Findings and Order Granting Accelerated Approval of
Proposed Rule Change

    The Commission finds that the proposed rule change is consistent
with the requirements of the Act and the rules and regulations
thereunder applicable to a national securities exchange.\12\
Specifically, the Commission finds that the proposed rule change is
consistent with Section 6(b)(4) \13\ of the Act, which requires that
the rules of a national securities exchange provide for the equitable
allocation of reasonable dues, fees, and other charges among members
and issuers and other persons using its facilities.
---------------------------------------------------------------------------

    \12\ In approving this proposal, the Commission has considered
its impact on efficiency, competition, and capital formation. 15
U.S.C 78c(f).
    \13\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

    As described more fully above, ISE recently amended DECN's fee
schedule for ISE Members pursuant to SR-ISE-2010-37 (the ``Member Fee
Filing''). The fee changes made pursuant to the Member Fee Filing
became operative on May 1, 2010. DECN receives rebates and is charged
fees for transactions it executes on EGDX or EDGA in its capacity as an
introducing broker for its non-ISE member subscribers. The current
proposal, which will apply retroactively to May 1, 2010, will allow
DECN to pass through the revised rebates and fees to the non-ISE member
subscribers for which it acts an introducing broker. The Commission
finds that the proposal is consistent with the Act because it will
provide rebates and charge fees to non-ISE member subscribers that are
equivalent to those established for ISE member subscribers in the
Member Fee Filing.\14\
---------------------------------------------------------------------------

    \14\ Id.
---------------------------------------------------------------------------

    ISE has requested that the Commission find good cause for approving
the proposed rule change prior to the thirtieth day after publication
of notice of filing thereof in the Federal Register. As discussed
above, the proposal will allow DECN to pass through to non-ISE member
subscribers the revised rebate and fees established for ISE member
subscribers in the Member Fee Filing, resulting in equivalent rebates
and fees for ISE member and non-member subscribers. In addition,
because the proposal will apply the revised rebates and fees
retroactively to May 1, 2010, the revised rebates and fees will have
the same effective date, thereby promoting consistency in the DECN's
fee schedule. Accordingly, the Commission finds good cause, pursuant to
Section 19(b)(2) of the Act, for approving the proposed rule change
prior to the thirtieth day after the date of publication of notice of
filing thereof in the Federal Register.

V. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\15\ that the proposed rule change (SR-ISE-2010-38) be, and hereby
is, approved on an accelerated basis.
---------------------------------------------------------------------------

    \15\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\16\
---------------------------------------------------------------------------

    \16\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-11398 Filed 5-12-10; 8:45 am]
BILLING CODE 8010-01-P


[Federal Register Volume 80, Number 70 (Monday, April 13, 2015)]
[Notices]
[Pages 19721-19722]
[FR Doc No: 2015-08340]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-74669; File No. SR-CBOE-2015-038]

Self-Regulatory Organizations; Chicago Board Options Exchange,
Incorporated; Notice of Filing and Immediate Effectiveness of a
Proposed Rule Change To Amend the Fees Schedule

April 7, 2015.
    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 April 1, 2015, Chicago Board Options Exchange, Incorporated
(the ``Exchange'' or ``CBOE'') filed with the Securities and Exchange
Commission (the ``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 proposes to amend its Fees Schedule. The text of the
proposed rule change is available on the Exchange's Web site (http://www.cboe.com/AboutCBOE/CBOELegalRegulatoryHome.aspx), at the Exchange's
Office of the Secretary, and at the Commission's Public Reference Room.

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

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

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

1. Purpose
    The Exchange proposes to amend its Fees Schedule, effective April
1, 2015. Specifically, the Exchange proposes to amend the Complex Order
Book (``COB'') Taker Surcharge. By way of background, the COB Taker
Surcharge is a $0.05 per contract per side surcharge for non-customer
complex order executions that take liquidity from the COB in all
underlying classes except OEX, XEO, SPX (including SPXW), SPXpm, SRO,
VIX, VXST, Volatility Indexes and binary options (``Underlying Symbol
List A \3\'') and mini-options. Additionally, the COB Taker Surcharge
is not assessed on non-customer complex order executions in the Complex
Order Auction (``COA''), the Automated Aim Mechanism (``AIM''), orders
originating from a Floor Broker PAR, or electronic executions against
single leg markets. The Exchange proposes to exclude from the COB Taker
Surcharge, stock-option order executions. Eliminating the surcharge for
stock-option orders will allow Trading Permit Holders (``TPHs'') who
engage in stock-option order executions the opportunity to pay lower
fees for such transactions and provide greater incentives for such
trading.
---------------------------------------------------------------------------

    \3\ As of April 1, 2015, Underlying Symbol List A will also
include the Russell 2000 Index (``RUT'').
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
the Securities Exchange Act of 1934 (the ``Act'') and the rules and
regulations thereunder applicable to the Exchange and, in particular,
the requirements of Section 6(b) of the Act.\4\ Specifically, the
Exchange believes the proposed rule change is consistent with the
Section 6(b)(5) \5\ requirements that the rules of an exchange be
designed to prevent fraudulent and manipulative acts and practices, to
promote just and equitable principles of trade, to foster cooperation
and coordination with persons engaged in regulating, clearing,
settling, processing information with respect to, and facilitation
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. Additionally,
the Exchange believes the proposed rule change is consistent with
Section 6(b)(4) of the Act,\6\ which requires that Exchange rules
provide for the equitable allocation of reasonable dues, fees, and
other charges among its Trading Permit Holders and other persons using
its facilities.
---------------------------------------------------------------------------

    \4\ 15 U.S.C. 78f(b).
    \5\ 15 U.S.C. 78f(b)(5).
    \6\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

    The Exchange believes that the proposal to exclude from the COB
Taker Surcharge stock-option orders is reasonable because it will allow
TPHs who engage in stock-option order trading the opportunity to pay
lower fees for such transactions. It is equitable and not unfairly
discriminatory because it is applied to all TPHs equally. Additionally,
the Exchange believes the proposed change is designed to attract
greater stock-option order flow to the Exchange. This would bring
greater liquidity to the market, which benefits all market
participants.

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

    The Exchange does not believe that the proposed rule changes will
impose any burden on competition that are not necessary or appropriate
in furtherance of the purposes of the Act. The Exchange does not
believe that the proposed rule change will impose any burden on
intramarket competition that is not necessary or appropriate in
furtherance of the purposes of the Act because the proposed change
applies to all TPHs. The Exchange does not believe

that the proposed rule change will impose any burden on intermarket
competition that is not necessary or appropriate in furtherance of the
purposes of the Act because the proposed change is intended to promote
competition and better improve the Exchange's competitive position and
make CBOE a more attractive marketplace in order to encourage market
participants to bring increased volume to the Exchange. To the extent
that the proposed changes make CBOE a more attractive marketplace for
market participants at other exchanges, such market participants are
welcome to become CBOE market participants.

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

    The Exchange neither solicited nor received comments on the
proposed rule change.

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 \7\ and paragraph (f) of Rule 19b-4 \8\
thereunder. At any time within 60 days of the filing of the proposed
rule change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission will institute proceedings to
determine whether the proposed rule change should be approved or
disapproved.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78s(b)(3)(A).
    \8\ 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 proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-CBOE-2015-038 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-CBOE-2015-038. 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 also will 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 Number SR-CBOE-2015-038 and should be
submitted on or before May 4, 2015.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\9\
---------------------------------------------------------------------------

    \9\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Brent J. Fields,
Secretary.
[FR Doc. 2015-08340 Filed 4-10-15; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 87, Number 85 (Tuesday, May 3, 2022)]
[Notices]
[Pages 26207-26208]
[FR Doc No: 2022-09459]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-D-0084]

Use of Circulating Tumor Deoxyribonucleic Acid for Early-Stage
Solid Tumor Drug Development; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Use of
Circulating Tumor DNA for Early-Stage Solid Tumor Drug Development.''
This draft guidance is intended to help sponsors planning to use
circulating cell-free plasma derived tumor deoxyribonucleic acid
(ctDNA) as a biomarker in cancer clinical trials conducted under an
investigational new drug application (IND) and/or to support marketing
approval of drugs and biological products for treating solid tumor
malignancies in the early-stage setting.

DATES: Submit either electronic or written comments on the draft
guidance by July 5, 2022 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

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-2022-D-0084 for ``Use of Circulating Tumor DNA for Early-Stage
Solid Tumor Drug Development.'' Received comments 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, 240-
402-7500.
     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>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002 or Office
of Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002 or
Office of the Center Director, Guidance and Policy Development, Center
for Devices and Radiological Health, 10903 New Hampshire Ave., Bldg.
66, Rm. 5431, Silver Spring, MD 20993-0002. Send one self-addressed
adhesive label to assist that office in processing your requests. See
the SUPPLEMENTARY INFORMATION section for electronic access to the
draft guidance document.

FOR FURTHER INFORMATION CONTACT: Julia Beaver, Center for Drug
Evaluation and Research, Food and Drug Administration, 10993 New
Hampshire Ave., Silver Spring, MD 20993-0002,<PHONE_NUMBER>; or Stephen
Ripley, Center of Biologics Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver
Spring, MD 20993,<PHONE_NUMBER>; or Soma Ghosh, Center for Devices and
Radiological Health, 10903 New Hampshire Ave., Bldg. 66, Rm. 3320,
Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Use of Circulating Tumor DNA for Early-Stage Solid Tumor
Drug Development.'' This draft guidance is intended to help sponsors
planning to use circulating cell-free plasma derived tumor ctDNA as a
biomarker in cancer clinical trials conducted under an IND and/or to
support marketing approval of drugs and biological products for
treating solid tumor malignancies in the early-stage setting.

    Certain patients with early-stage solid tumors can be cured with
local therapy alone (e.g., surgery, radiation, or chemoradiation),
other patients require (neo)adjuvant systemic therapy in order to be
cured, and others may progress to metastatic disease despite surgery
and/or systemic therapy. ctDNA is tumor-derived fragmented DNA shed
into a patient's bloodstream that is not associated with cells. ctDNA
quantity can vary among individuals and depends on the type of tumor,
location, stage, tumor burden, and response to therapy. ctDNA as a
biomarker has a number of potential regulatory and clinical uses in the
early-stage setting that may assist and expedite drug development. In
the early-stage cancer setting, ctDNA may be used to detect a certain
targetable alteration, to enrich a high- or low-risk population for
study in a trial, to reflect a patient's response to treatment, or,
potentially, as an early marker of efficacy.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Use of
Circulating Tumor DNA for Early-Stage Solid Tumor Drug Development.''
It does not establish any rights for any person and is not binding on
FDA or the public. You can use an alternative approach if it satisfies
the requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR parts 50 and 56 have been approved under OMB
control number 0910-0130; the collections of information in 21 CFR part
314 have been approved under OMB control number 0910-0001; the
collections of information in 21 CFR part 312 have been approved under
OMB control number 0910-0014; the collections of information in 21 CFR
part 601 have been approved under OMB control number 0910-0338; the
collections of information in 21 CFR part 800 have been approved under
OMB control number 0910-0625 and the collections of information
pertaining to submission of a biologics license application under
section 351(k) of the Public Health Service Act (42 U.S.C. 262(k)) have
been approved under OMB control number 0910-0719.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: April 26, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-09459 Filed 5-2-22; 8:45 am]
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