[Federal Register Volume 78, Number 133 (Thursday, July 11, 2013)]
[Proposed Rules]
[Pages 41731-41735]
[FR Doc No: 2013-16078]

=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 49

[EPA-R09-OAR-2013-0489; FRL-9830-5]

Source Specific Federal Implementation Plan for Implementing Best
Available Retrofit Technology for Four Corners Power Plant; Navajo
Nation; Extension of Notification Deadline

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: On August 24, 2012, EPA took final action to promulgate a
Federal Implementation Plan (FIP) to implement the Best Available
Retrofit Technology (BART) requirement of the Regional Haze Rule for
the Four Corners Power Plant (FCPP), located on the Navajo Nation.
EPA's final action required the owners of FCPP to choose between two
strategies for compliance: compliance with the emission limits in EPA's
final BART determination; or compliance with an alternative to BART,
originally put forth by the owners of FCPP, that included closure of
Units 1, 2, and 3 at FCPP and installation of new air pollution
controls to meet BART limits on Units 4 and 5. EPA's final action
required the owners of FCPP to provide notification to EPA by July 1,
2013, of its selection of which BART compliance strategy it would
implement at FCPP. On June 19, 2013, Arizona Public Service (APS), the
operator and a co-owner of FCPP, requested that EPA extend the
notification date from July 1 to December 31, 2013, due to new
uncertainties that complicate its decision related to BART compliance.
These uncertainties result from a recent decision by the Arizona
Corporation Commission to explore retail competition of the electricity
market in Arizona. Because the basis provided by APS for an extended
notification date is reasonable and justified given the uncertainties
in the electrical market in Arizona, EPA is proposing to extend the
date by which APS must notify EPA of its BART compliance strategy, from
July 1, 2013 to December 31, 2013. EPA is not proposing to amend any
other requirements in the FIP for FCPP.

DATES: Comments must be postmarked no later than August 12, 2013.

ADDRESSES: Submit comments, identified by docket number EPA-R09-OAR-
2013-0489, by one of the following methods:
    (1) Federal eRulemaking Portal: www.regulations.gov. Follow the on-
line instructions.
    (2) Email<EMAIL_ADDRESS>    (3) Mail or deliver: Anita Lee (Air-2), U.S. Environmental
Protection Agency Region 9, 75 Hawthorne Street, San Francisco, CA
94105-3901.
    Instructions: All comments will be included in the public docket
without change and may be made available online at www.regulations.gov,
including any personal information provided, unless the comment
includes Confidential Business Information (CBI) or other information
whose disclosure is restricted by statute. Information that you
consider CBI or otherwise protected should be clearly identified as
such and should not be submitted through www.regulations.gov or email.
www.regulations.gov is an ``anonymous access'' system, and EPA will not
know your identity or contact information unless you provide it in the
body of your comment. If you send an email directly to EPA, your email
address will be automatically captured and included as part of the
public comment. If EPA cannot read your comment due to technical
difficulties and cannot contact you for clarification, EPA may not be
able to consider your comment.
    Docket: The index to the docket for this action is available
electronically at www.regulations.gov and in hard copy at EPA Region 9,
75 Hawthorne Street, San Francisco, California. While documents in the
docket are listed in the index, some information may be publicly
available only at EPA Region 9 (e.g., maps, voluminous reports,
copyrighted material), and some may not be publicly available in either

location (e.g., CBI). To inspect the hard copy materials, please
schedule an appointment during normal business hours with the contact
person listed in the FOR FURTHER INFORMATION CONTACT section.

FOR FURTHER INFORMATION CONTACT: Anita Lee, EPA Region 9, (415) 972-
3958<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, ``we'', ``us'',
and ``our'' refer to EPA.

Table of Contents

I. Background
II. Today's Action
III. Administrative Requirements

I. Background

    FCPP is a privately owned and operated coal-fired power plant
located on the Navajo Nation Indian Reservation near Farmington, New
Mexico. Based on lease agreements signed in 1960, FCPP was constructed
and has been operating on real property held in trust by the Federal
government for the Navajo Nation. The facility consists of five coal-
fired electric utility steam generating units with a total capacity of
2060 megawatts (MW). Units 1, 2, and 3 at FCPP are owned entirely by
Arizona Public Service (APS) which serves as the facility operator, and
are rated to 170 MW (Units 1 and 2) and 220 MW (Unit 3). Units 4 and 5
are each rated to a capacity of 750 MW, and are co-owned by six
entities: Southern California Edison (48 percent), APS (15 percent),
Public Service Company of New Mexico (13 percent), Salt River Project
(10 percent), El Paso Electric Company (7 percent), and Tucson Electric
Power (7 percent).
    On August 24, 2012, EPA promulgated a final rule that established
limits for oxides of nitrogen (NOX) emissions from FCPP
under the BART provision of the Regional Haze Rule (77 FR 51620). The
final rule required the owners of FCPP to choose between two strategies
for BART compliance: (1) compliance with a plant-wide BART emission
limit of 0.11 pounds of NOX per million British Thermal
Units of heat input (lb/MMBtu) by October 23, 2017, or (2) retirement
of Units 1, 2, and 3 by January 1, 2014 and compliance with a BART
emission limit of 0.098 lb/MMBtu on Units 4 and 5 by July 31, 2018. The
second BART compliance strategy, involving retirement of Units 1, 2,
and 3, was based on a plan originally put forth by APS. This compliance
strategy was proposed and finalized as an alternative emission control
strategy that achieved greater reasonable progress than BART. For
additional information regarding EPA's analyses regarding BART and the
alternative emission control strategy, see EPA's BART proposal (75 FR
64221, October 29, 2010), supplemental proposal (76 FR 10530, February
25, 2011) and final rule (77 FR 51620, August 24, 2012).
    As discussed in our supplemental proposal published on February 25,
2011, the choice to retire Units 1, 2, and 3, and comply with BART
emission limits on Units 4 and 5 is contingent upon the resolution of
several issues, including a renewed site lease with the Navajo Nation,
a renewed coal contract, and regulatory approvals from the Arizona
Corporation Commission (ACC), California Public Utilities Commission
(CPUC), and Federal Energy Regulatory Commission (FERC). The ACC, CPUC,
and FERC regulatory approvals were necessary because APS would purchase
the 48 percent interest of Units 4 and 5 currently owned by Southern
California Edison (SCE). Because the regulatory approvals, renewed site
lease, and renewed coal contract were expected to require significant
time and effort by APS, other owners, and the Navajo Nation, EPA's
final rule included requirements for the owner or operator of FCPP to
(1) update EPA by January 1, 2013, on the status of lease negotiations
and regulatory approvals, and (2) notify EPA, by July 1, 2013, of the
BART strategy it elects to implement, including a plan and schedule for
compliance with its chosen strategy.\1\
---------------------------------------------------------------------------

    \1\ See 40 CFR 49.5512(i)(4).
---------------------------------------------------------------------------

    On December 31, 2012, APS provided an update to EPA regarding the
status of the approvals required for implementing the alternative
emission control strategy.\2\ APS stated that on March 7, 2011, APS and
the Navajo Nation executed an agreement to extend the lease for FCPP to
July 6, 2041. The lease renewal must be reviewed and approved by the
U.S. Bureau of Indian Affairs, which triggers review under the National
Environmental Policy Act (NEPA), and other related reviews, including
under Section 7 of the Endangered Species Act. NEPA review is underway
and expected to conclude in time to allow for a Record of Decision by
January 2015. EPA is a cooperating agency in the NEPA process. In its
December 31, 2012 update letter, APS also stated that it is in on-going
negotiation for a new coal supply agreement with its coal supplier.
Finally, APS confirmed that it had obtained regulatory approvals to
purchase SCE's 48 percent interest of Units 4 and 5.\3\
---------------------------------------------------------------------------

    \2\ See Letter from Susan Kidd, Director Environmental Policies
and Programs, Arizona Public Service, to Jared Blumenfeld, Regional
Administrator, EPA Region 9, dated December 31, 2012.
    \3\ APS received approval from the ACC on April 24, 2012; from
FERC on November 27, 2012; and from the Department of Justice/
Federal Trade Commission on July 2, 2012. As discussed in our final
rulemaking dated August 24, 2012, EPA already understood that the
CPUC approved the sale of SCE's shares of Units 4 and 5 at FCPP to
APS on March 22, 2012.
---------------------------------------------------------------------------

    However, in a letter dated June 19, 2013, APS requested that EPA
extend the date by which APS must provide notification of its BART
implementation strategy for FCPP.\4\ APS explained that it had
previously expected to meet the July 1, 2013 notification date because
it had completed the processes to obtain regulatory approvals to
purchase SCE's shares of Units 4 and 5, and renewal of the lease and
coal contract were underway. Then, unexpectedly, in May 2013, the ACC
voted to re-examine deregulation of the retail electric market in
Arizona.\5\ In its June 19, 2013 letter, APS explains that, depending
on its structure and reach, a deregulated retail electric market could
significantly change the BART compliance strategy for FCPP. Thus, APS
is no longer able to make an informed decision by July 1, 2013. APS
states that its decision requires more certainty regarding the
likelihood of deregulation in Arizona. APS also filed a Form 8-K with
the United States Securities and Exchange Commission disclosing the
uncertainty caused by the ACC decision to examine deregulation.\6\
---------------------------------------------------------------------------

    \4\ See letter from Ann Becker, Vice President, Environmental
and Chief Sustainability Officer, Arizona Public Service, to Jared
Blumenfeld, Regional Administrator, EPA Region 9, dated June 19,
2013.
    \5\ http://www.azcc.gov/Divisions/Administration/About/Letters/5-23-13%20Retail%20Competition%2013-0135.pdf.
    \6\ Form 8-K was appended to the June 19, 2013 letter from Ann
Becker to Jared Blumenfeld.
---------------------------------------------------------------------------

    APS has requested that EPA extend the notification date for its
selection of the BART compliance strategy to December 31, 2013. APS
noted that the potential for deregulation of the retail electric market
in Arizona was not foreseen at the time of our final rulemaking in
2012. APS also noted that extending the notification date by six months
will not affect public health or the environment because the BART
compliance dates, in 2017 or 2018, depending on the compliance strategy
selected, are not linked to the notification date and remain unchanged.

II. EPA's Proposed Action

    EPA is proposing to extend the date by which the owner or operator
of FCPP must notify EPA of its selected BART compliance strategy from
July 1, 2013 to

December 31, 2013. This action proposes to revise one provision in the
existing source-specific federal implementation plan for FCPP, codified
at 40 CFR 49.5512(i).

A. Justification for Proposing to Extend Notification Date

    EPA's final rule required the owner or operator of FCPP to notify
EPA by July 1, 2013, regarding whether it would elect to comply with
BART or the alternative emission control strategy. Specifically, 40 CFR
49.5512(i)(4) requires the owner and operator of FCPP to provide EPA
with updates and additional information regarding the status of various
approvals and processes that must be resolved in order for the owner
and operator to determine which BART strategy it will implement to
comply with the FIP. The notification date is not a substantive
requirement of our BART determination, nor is it a requirement related
to the emission limit constituting BART or the timeframe for BART
compliance, as defined in the CAA or the Regional Haze Rule. EPA notes
that the FIP continues to require FCPP to meet the emission limits
required under BART or the alternative emission control strategy by the
compliance dates specified in our final rulemaking, codified at 40 CFR
49.5512(i)(2) and (3), regardless of the extension of the notification
date in (i)(4).
    EPA recognizes that the potential re-examination of a competitive
retail electric market in Arizona represents new uncertainties for APS
and the other owners of FCPP regarding decisions related to the closure
of Units 1, 2, and 3, and capital investments to install new air
pollution controls to meet BART limits for Units 4 and 5. EPA
understands that the ACC has opened a docket to accept comments on
deregulation until August 16, 2013, and plans to convene an Open
Meeting, after it has reviewed written comments, to discuss issues and
information filed to the docket. EPA recognizes that uncertainty may
still exist after the Open Meeting, depending on the direction the ACC
takes regarding further examination of deregulation. Therefore, EPA is
proposing to find that a December 31, 2013 notification date is
necessary to provide APS with the needed flexibility in determining
whether to implement BART or the alternative emission control strategy
to reduce FCPP's NOX emissions by 80-87 percent.

B. Notification Date Extension Does Not Interfere with Attainment or
Reasonable Further Progress

    The CAA requires that any revision to an implementation plan shall
not be approved by the Administrator ``if the revision would interfere
with any applicable requirement concerning attainment and reasonable
further progress . . . or any other applicable requirement of [the
CAA].'' \7\
---------------------------------------------------------------------------

    \7\ See section 110(l) of the CAA.
---------------------------------------------------------------------------

    EPA has promulgated health-based standards, known as the national
ambient air quality standards (NAAQS), for seven pollutants, including
NO2, a component of NOX, and pollutants such as
ozone and particulate matter with a diameter less than or equal to 2.5
micrometers (PM2.5), that are formed in the atmosphere from
reactions between NOX and other pollutants.\8\ Using a
process that considers air quality data and other factors, EPA
designates areas as ``nonattainment'' if those areas cause or
contribute to violations of a NAAQS. Reasonable further progress, as
defined in section 171 of the CAA, is related to attainment and means
``such annual incremental reductions in emissions of the relevant air
pollutant . . . for the purpose of ensuring attainment of the
applicable [NAAQS].''
---------------------------------------------------------------------------

    \8\ The other pollutants are sulfur dioxide, carbon monoxide,
lead, and PM10.
---------------------------------------------------------------------------

    FCPP is located on the Navajo Nation, in the northeastern corner of
New Mexico. This area is not designated nonattainment with any NAAQS.
Regardless of the decision to implement BART or the alternative
emission control strategy, emissions of NOX from FCPP will
be reduced as a result of EPA's FIP implementing the BART provisions of
the Regional Haze Rule. EPA's proposed extension of the notification
date does not affect the compliance dates associated with BART or the
alternative emission control strategy. Therefore, a six-month extension
of the notification date will not interfere with attainment or
reasonable further progress for any air quality standard.

C. Notification Date Extension Does Not Interfere With Any Other
Applicable Requirement of the CAA

    The other requirement of the CAA that is applicable to FCPP is the
BART provision under the visibility protection requirements for class I
Federal areas under section 169A(b)(2)(A). In our final rulemaking in
August 24, 2012, EPA promulgated a finding, under the Tribal Authority
Rule (TAR), that it was necessary or appropriate to promulgate a
source-specific FIP for FCPP to achieve emission reductions required by
the BART provision of the CAA.\9\ As stated previously, the
notification requirements included in our final FIP do not affect or
change the compliance dates for BART or the alternative emission
control strategy. Therefore, the six-month extension of the
notification date that we are proposing will not interfere with the
BART requirement of the CAA.
---------------------------------------------------------------------------

    \9\ See CAA section 169A(b)(2)(A) and our final rulemaking dated
August 24, 2012 (77 FR 51620) for additional information related to
the TAR. In our FCPP rulemaking, EPA did not propose or finalize a
finding that it was necessary or appropriate under the TAR to
promulgate a FIP to implement a long-term strategy for making
reasonable progress toward the national visibility goal under
section 169A(b)(2)(B) of the CAA.
---------------------------------------------------------------------------

III. Administrative Requirements

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

    This action proposes to extend the date for a single source to
notify EPA regarding its decision to implement BART or an alternative
emission control strategy. This type of action for a single source is
exempt from review under Executive Orders (EO) 12866 (58 FR 51735,
October 4, 1993) and EO 13563 (76 FR 3821, January 21, 2011).

B. Paperwork Reduction Act

    This action does not impose an information collection burden under
the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq.
Burden is defined at 5 CFR 1320.3(b). Because the proposed action
merely extends a compliance date, it does not impose an information
collection burden and the Paperwork Reduction Act does not apply.

C. Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA) generally requires an agency
to prepare a regulatory flexibility analysis of any rule subject to
notice and comment rulemaking requirements under the Administrative
Procedure Act or any other statute unless the agency certifies that the
rule will not have a significant economic impact on a substantial
number of small entities. Small entities include small businesses,
small organizations, and small governmental jurisdictions.
    For purposes of assessing the impacts of today's proposed rule on
small entities, small entity is defined as: (1) a small business as
defined by the Small Business Administration's (SBA) regulations at 13
CFR 121.201; (2) a small governmental jurisdiction that is a

government of a city, county, town, school district or special district
with a population of less than 50,000; and (3) a small organization
that is any not-for-profit enterprise which is independently owned and
operated and is not dominant in its field.
    After considering the economic impacts of this proposed action on
small entities, I certify that this proposed action will not have a
significant economic impact on a substantial number of small entities.
The owners of FCPP are not a small entities. See Mid-Tex Electric
Cooperative, Inc. v. FERC, 773 F.2d 327 (D.C. Cir. 1985). Additionally,
the extended notification date being proposed today was requested by
the operator and co-owner of FCPP. We continue to be interested in the
potential impacts of the proposed rule on small entities and welcome
comments on issues related to such impacts.

D. Unfunded Mandates Reform Act (UMRA)

    Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), 2
U.S.C. 1531-1538, requires Federal agencies, unless otherwise
prohibited by law, to assess the effects of their regulatory actions on
State, local, and tribal governments and the private sector. Federal
agencies must also develop a plan to provide notice to small
governments that might be significantly or uniquely affected by any
regulatory requirements. The plan must enable officials of affected
small governments to have meaningful and timely input in the
development of EPA regulatory proposals with significant Federal
intergovernmental mandates and must inform, educate, and advise small
governments on compliance with the regulatory requirements.
    This proposed rule does not contain a Federal mandate that may
result in expenditures of $100 million or more for state, local, and
tribal governments, in the aggregate, or the private sector in any one
year. This rule merely proposes a six-month extension of a notification
date in an existing federal implementation plan for FCPP. Thus, this
rule is not subject to the requirements of sections 202 or 205 of UMRA.
    This proposed rule is also not subject to the requirements of
section 203 of UMRA because it contains no regulatory requirements that
might significantly or uniquely affect small governments. This proposed
rule does not impose regulatory requirements on any government entity.

E. 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 in the distribution of power
and responsibilities among the various levels of government, as
specified in Executive Order 13132. This action proposes a six-month
extension of a notification date. Thus, Executive Order 13132 does not
apply to this action.
    In the spirit of Executive Order 13132, and consistent with EPA
policy to promote communications between EPA and State and local
governments, EPA specifically solicits comment on this proposed action
from State and local officials.

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

    Under Executive Order 13175 (65 FR 67249, November 9, 2000), EPA
may not issue a regulation that has tribal implications, that imposes
substantial direct compliance costs, and that is not required by
statute, unless the federal government provides the funds necessary to
pay the direct compliance costs incurred by tribal governments, or EPA
consults with tribal officials early in the process of developing the
proposed regulation and develops a tribal summary impact statement.
    EPA has concluded that this proposed rule may have tribal
implications because the Four Corners Power Plant is located on
reservation lands of the Navajo Nation. However, it will neither impose
substantial direct compliance costs on tribal governments, nor preempt
tribal law.
    EPA consulted with tribal officials early in the process of
developing BART regulations for the Four Corners Power Plant to permit
them to have meaningful and timely input into its development. During
the comment period for prior EPA actions related to the EPA's BART FIP
for FCPP, the Navajo Nation raised concerns to EPA about the potential
economic impacts of our BART determination on the Navajo Nation. EPA
consulted the Navajo Nation regarding these concerns. Additional
details of our consultation with the Navajo Nation are provided in
sections III.H and IV.F of our final rulemaking published on August 24,
2012 (77 FR 51620). For this proposed action to extend the notification
date by six months, we will consult with the Navajo Nation if requested
as we proceed with this action. EPA notified the Navajo Nation
Environmental Protection Agency regarding the request from APS to
extend the notification date on June 25, 2013.
    EPA specifically solicits additional comment on this proposed
action from tribal officials.

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

    EPA interprets EO 13045 (62 FR 19885, April 23, 1997) as applying
only to those regulatory actions that concern health or safety risks,
such that the analysis required under section 5-501 of the EO has the
potential to influence the regulation. This action is not subject to EO
13045 because it does not establish an environmental standard intended
to mitigate health or safety risks. This proposed action addresses
regional haze and visibility protection.

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

    This action is not subject to Executive Order 13211 (66 FR 28355
(May 22, 2001)), because it is exempt under Executive Order 12866.

I. National Technology Transfer and Advancement Act

    Section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, 12 (10) (15 U.S.C. 272 note)
directs EPA to use voluntary consensus standards (VCS) in its
regulatory activities unless to do so would be inconsistent with
applicable law or otherwise impractical. VCS are technical standards
(e.g., materials specifications, test methods, sampling procedures and
business practices) that are developed or adopted by the VCS bodies.
The NTTAA directs EPA to provide Congress, through annual reports to
OMB, with explanations when the Agency decides not to use available and
applicable VCS.
    This proposed rulemaking does not involve technical standards.
Therefore, EPA is not considering the use of any VCS.

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

    Executive Order 12898 (59 FR 7629, February 16, 1994), establishes
federal executive policy on environmental justice. Its main provision
directs federal agencies, to the greatest extent practicable and
permitted by law, to make environmental justice part of their mission
by identifying and addressing,

as appropriate, disproportionately high and adverse human health or
environmental effects of their programs, policies, and activities on
minority populations and low-income populations in the United States.
    EPA has determined that this proposed rule, if finalized, will not
have disproportionately high and adverse human health or environmental
effects on minority or low-income populations because it does not
affect the level of protection provided to human health or the
environment. This proposed rule does not change any applicable emission
limit for FCPP. This proposed rule merely extends a notification date
by six months.

List of Subjects in 40 CFR Part 49

    Environmental protection, Air pollution control, Indians,
Intergovernmental relations, Nitrogen Dioxide.

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

    Dated: June 25, 2013.
Alexis Strauss,
Acting Regional Administrator, Region 9.
    For the reasons stated in the preamble, Title 40, chapter I of the
Code of Federal Regulations is proposed to be amended as follows:

PART 49--[AMENDED]

0
1. The authority citation for part 49 continues to read as follows:

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

0
2. In Sec.  49.5512, revise paragraph (i)(4) to read as follows:

Sec.  49.5512  Federal Implementation Plan Provisions for Four Corners
Power Plant, Navajo Nation.

* * * * *
    (i) * * *
    (4) By January 1, 2013, the owner or operator shall submit a letter
to the Regional Administrator updating EPA of the status of lease
negotiations and regulatory approvals required to comply with paragraph
(i)(3) of this section. By December 31, 2013, the owner or operator
shall notify the Regional Administrator by letter whether it will
comply with paragraph (i)(2) of this section or whether it will comply
with paragraph (i)(3) of this section and shall submit a plan and time
table for compliance with either paragraph (i)(2) or (3) of this
section. The owner or operator shall amend and submit this amended plan
to the Regional Administrator as changes occur.
* * * * *
[FR Doc. 2013-16078 Filed 7-10-13; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 86, Number 203 (Monday, October 25, 2021)]
[Notices]
[Pages 58964-58965]
[FR Doc No: 2021-23152]

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

SECURITIES AND EXCHANGE COMMISSION

[SEC File No. 270-518, OMB Control No. 3235-0576]

Submission for OMB Review; Comment Request

Upon Written Request Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE, Washington, DC
20549-2736

Extension:
    Regulation G

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') has submitted to the Office of Management
and Budget this request for extension of the previously approved
collection of information discussed below.
    Regulation G (17 CFR 244.100-244.102) under the Securities Exchange
Act of 1934 (the ``Exchange Act'') (15 U.S.C. 78a et seq.) requires
publicly reporting companies that disclose or releases financial
information in a manner that is calculated or presented other than in
accordance with generally accepted accounting principles (``GAAP'') to
provide a reconciliation of

the non-GAAP financial information to the most directly comparable GAAP
financial measure. Regulation G implemented the requirements of Section
401 of the Sarbanes-Oxley Act of 2002 (15 U.S.C. 7261). We estimate
that approximately 14,000 public companies must comply with Regulation
G approximately six times a year for a total of 84,000 responses
annually. We estimated that it takes approximately 0.5 hours per
response (0.5 hours per response x 84,000 responses) for a total
reporting burden of 42,000 hours annually.
    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 control number.
    The public may view background documentation for this information
collection at the following website: www.reginfo.gov. Find this
particular information collection by selecting ``Currently under 30-day
Review--Open for Public Comments'' or by using the search function.
Written comments and recommendations for the proposed information
collection should be sent within 30 days of publication of this notice
to (i) www.reginfo.gov/public/do/PRAMain and (ii) David Bottom,
Director/Chief Information Officer, Securities and Exchange Commission,
c/o Cynthia Roscoe, 100 F Street NE, Washington, DC 20549, or by
sending an email to: [email protected].

    Dated: October 19, 2021.
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2021-23152 Filed 10-22-21; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 86, Number 139 (Friday, July 23, 2021)]
[Notices]
[Pages 39040-39044]
[FR Doc No: 2021-15680]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1584]

Authorization of Emergency Use of Certain Medical Devices During
COVID-19; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
issuance of Emergency Use Authorizations (EUAs) (the Authorizations)
for certain medical devices related to the Coronavirus Disease 2019
(COVID-19) public health emergency. FDA has issued the Authorizations
listed in this document under the Federal Food, Drug, and Cosmetic Act
(FD&C Act). These Authorizations contain, among other things,
conditions on the emergency use of the authorized products. The
Authorizations follow the February 4, 2020, determination by the
Secretary of Health and Human Services (HHS) that there is a public
health emergency that has a significant potential to affect national
security or the health and security of U.S. citizens living abroad, and
that involves the virus that causes COVID-19, and the subsequent
declarations on February 4, 2020, March 2, 2020, and March 24, 2020,
that circumstances exist justifying the authorization of emergency use
of in vitro diagnostics for detection and/or

diagnosis of the virus that causes COVID-19, personal respiratory
protective devices, and medical devices, including alternative products
used as medical devices, respectively, subject to the terms of any
authorization issued under the FD&C Act. These Authorizations, which
include an explanation of the reasons for issuance, are listed in this
document, and can be accessed on FDA's website from the links
indicated.

DATES: These Authorizations are effective on their date of issuance.

ADDRESSES: Submit written requests for single copies of an EUA to the
Office of Counterterrorism and Emerging Threats, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4338, Silver
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist
that office in processing your request or include a fax number to which
the Authorization may be sent. See the SUPPLEMENTARY INFORMATION
section for electronic access to the Authorization.

FOR FURTHER INFORMATION CONTACT: Jennifer J. Ross, Office of
Counterterrorism and Emerging Threats, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 1, Rm. 4332, Silver Spring, MD 20993-
0002,<PHONE_NUMBER> (this is not a toll free number).

SUPPLEMENTARY INFORMATION:

I. Background

    Section 564 of the FD&C Act (21 U.S.C. 360bbb-3) allows FDA to
strengthen the public health protections against biological, chemical,
radiological, or nuclear agent or agents. Among other things, section
564 of the FD&C Act allows FDA to authorize the use of an unapproved
medical product or an unapproved use of an approved medical product in
certain situations. With this EUA authority, FDA can help ensure that
medical countermeasures may be used in emergencies to diagnose, treat,
or prevent serious or life-threatening diseases or conditions caused by
a biological, chemical, radiological, or nuclear agent or agents when
there are no adequate, approved, and available alternatives.
    Section 564(b)(1) of the FD&C Act provides that, before an EUA may
be issued, the Secretary of HHS must declare that circumstances exist
justifying the authorization based on one of the following grounds: (1)
A determination by the Secretary of Homeland Security that there is a
domestic emergency, or a significant potential for a domestic
emergency, involving a heightened risk of attack with a biological,
chemical, radiological, or nuclear agent or agents; (2) a determination
by the Secretary of Defense that there is a military emergency, or a
significant potential for a military emergency, involving a heightened
risk to U.S. military forces, including personnel operating under the
authority of title 10 or title 50 of the U.S. Code, of attack with (A)
a biological, chemical, radiological, or nuclear agent or agents; or
(B) an agent or agents that may cause, or are otherwise associated
with, an imminently life-threatening and specific risk to U.S. military
forces; \1\ (3) a determination by the Secretary of HHS that there is a
public health emergency, or a significant potential for a public health
emergency, that affects, or has a significant potential to affect,
national security or the health and security of U.S. citizens living
abroad, and that involves a biological, chemical, radiological, or
nuclear agent or agents, or a disease or condition that may be
attributable to such agent or agents; or (4) the identification of a
material threat by the Secretary of Homeland Security pursuant to
section 319F-2 of the Public Health Service (PHS) Act (42 U.S.C. 247d-
6b) sufficient to affect national security or the health and security
of U.S. citizens living abroad.
---------------------------------------------------------------------------

    \1\ In the case of a determination by the Secretary of Defense,
the Secretary of HHS shall determine within 45 calendar days of such
determination, whether to make a declaration under section 564(b)(1)
of the FD&C Act, and, if appropriate, shall promptly make such a
declaration.
---------------------------------------------------------------------------

    Once the Secretary of HHS has declared that circumstances exist
justifying an authorization under section 564 of the FD&C Act, FDA may
authorize the emergency use of a drug, device, or biological product if
the Agency concludes that the statutory criteria are satisfied. Under
section 564(h)(1) of the FD&C Act, FDA is required to publish in the
Federal Register a notice of each authorization, and each termination
or revocation of an authorization, and an explanation of the reasons
for the action. Under section 564(h)(1) of the FD&C Act, revisions to
an authorization shall be made available on the internet website of the
FDA. Section 564 of the FD&C Act permits FDA to authorize the
introduction into interstate commerce of a drug, device, or biological
product intended for use when the Secretary of HHS has declared that
circumstances exist justifying the authorization of emergency use.
Products appropriate for emergency use may include products and uses
that are not approved, cleared, or licensed under section 505, 510(k),
512, or 515 of the FD&C Act (21 U.S.C. 355, 360(k), 360b, or 360e) or
section 351 of the PHS Act (42 U.S.C. 262), or conditionally approved
under section 571 of the FD&C Act (21 U.S.C. 360ccc). FDA may issue an
EUA only if, after consultation with the HHS Assistant Secretary for
Preparedness and Response, the Director of the National Institutes of
Health, and the Director of the Centers for Disease Control and
Prevention (CDC) (to the extent feasible and appropriate given the
applicable circumstances), FDA \2\ concludes: (1) That an agent
referred to in a declaration of emergency or threat can cause a serious
or life-threatening disease or condition; (2) that, based on the
totality of scientific evidence available to FDA, including data from
adequate and well-controlled clinical trials, if available, it is
reasonable to believe that (A) the product may be effective in
diagnosing, treating, or preventing (i) such disease or condition; or
(ii) a serious or life-threatening disease or condition caused by a
product authorized under section 564, approved or cleared under the
FD&C Act, or licensed under section 351 of the PHS Act, for diagnosing,
treating, or preventing such a disease or condition caused by such an
agent; and (B) the known and potential benefits of the product, when
used to diagnose, prevent, or treat such disease or condition, outweigh
the known and potential risks of the product, taking into consideration
the material threat posed by the agent or agents identified in a
declaration under section 564(b)(1)(D) of the FD&C Act, if applicable;
(3) that there is no adequate, approved, and available alternative to
the product for diagnosing, preventing, or treating such disease or
condition; (4) in the case of a determination described in section
564(b)(1)(B)(ii), that the request for emergency use is made by the
Secretary of Defense; and (5) that such other criteria as may be
prescribed by regulation are satisfied. No other criteria for issuance
have been prescribed by regulation under section 564(c)(4) of the FD&C
Act.
---------------------------------------------------------------------------

    \2\ The Secretary of HHS has delegated the authority to issue an
EUA under section 564 of the FD&C Act to the Commissioner of Food
and Drugs.
---------------------------------------------------------------------------

II. Electronic Access

    An electronic version of this document and the full text of the
Authorizations are aavailable on the internet and can be accessed from
https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization.

III. The Authorizations

    Having concluded that the criteria for the issuance of the
following Authorizations under section 564(c) of the FD&C Act are met,
FDA has authorized the emergency use of the following products for
diagnosing, treating, or preventing COVID-19 subject to the terms of
each Authorization. The Authorizations in their entirety, including any
authorized fact sheets and other written materials, can be accessed
from the FDA web page entitled ``Emergency Use Authorization,''
available at https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization.
The lists that follow include Authorizations issued from February 16,
2021, through May 31, 2021, and we have included explanations of the
reasons for their issuance, as required by section 564(h)(1) of the
FD&C Act. In addition, the EUAs that have been reissued can be accessed
from FDA's web page: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization.
    FDA is hereby announcing the following Authorizations for molecular
diagnostic and antigen tests for COVID-19, excluding multianalyte
tests: \3\
---------------------------------------------------------------------------

    \3\ As set forth in the EUAs for these products, FDA has
concluded that: (1) SARS-CoV-2, the virus that causes COVID-19, can
cause a serious or life-threatening disease or condition, including
severe respiratory illness, to humans infected by this virus; (2)
based on the totality of scientific evidence available to FDA, it is
reasonable to believe that the products may be effective in
diagnosing COVID-19, and that the known and potential benefits of
the products, when used for diagnosing COVID-19, outweigh the known
and potential risks of such products; and (3) there is no adequate,
approved, and available alternative to the emergency use of the
products.
---------------------------------------------------------------------------

     University of Illinois Office of the Vice President for
Economic Development and Innovation's covidSHIELD, issued February 24,
2021;
     Viracor Eurofins Clinical Diagnostics's Viracor SARS-CoV-2
Assay DTC, issued February 26, 2021;
     Quidel Corporation's QuickVue At-Home COVID-19 Test,
issued March 1, 2021;
     Clinical Research Sequencing Platform (CRSP), LLC at the
Broad Institute of the Massachusetts Institute of Technology and
Harvard's CRSP SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR
Diagnostic Assay (Version 3), issued March 5, 2021;
     Cue Health Inc.'s Cue COVID-19 Test for Home and Over The
Counter (OTC) Use, issued March 5, 2021;
     Color Health, Inc.'s Color SARS-CoV-2 RT-LAMP Diagnostic
Assay DTC, issued March 19, 2021;
     Twist Bioscience Corporation's SARS-CoV-2 NGS Assay,
issued March 23, 2021;
     STS Lab Holdco's (a subsidiary of Amazon.com Services
LLC), Amazon Real-Time RT-PCR Test for Detecting SARS-CoV-2, issued
March 25, 2021;
     DiaSorin, Inc.'s LIAISON SARS-CoV-2 Ag, issued March 26,
2021;
     Abbott Diagnostics Scarborough, Inc.'s BinaxNOW COVID-19
Ag 2 Card, issued March 31, 2021;
     Quidel Corporation's QuickVue At-Home OTC COVID-19 Test,
issued March 31, 2021;
     Abbott Diagnostics Scarborough, Inc.'s BinaxNOW COVID-19
Antigen Self Test, issued March 31, 2021;
     Abbott Diagnostics Scarborough, Inc.'s BinaxNOW COVID-19
Ag Card 2 Home Test, issued March 31, 2021;
     Thermo Fisher Scientific's Amplitude Solution with the
TaqPath COVID-19 High-Throughput Combo Kit, issued April 9, 2021;
     Lucira Health, Inc.'s Lucira CHECK[radic]IT COVID-19 Test
Kit, issued April 9, 2021;
     PerkinElmer Genomics's PerkinElmer SARS-CoV-2 RT-qPCR
Reagent Kit, issued April 12, 2021;
     Qorvo Biotechnologies, LLC.'s Omnia SARS-CoV-2 Antigen
Test, issued April 13, 2021;
     Clinical Enterprise, Inc.'s Clinical Enterprise SARS-CoV-2
RT-PCR Assay DTC, issued April 13, 2021;
     Clinical Enterprise, Inc.'s Clinical Enterprise SARS-CoV-2
RT-PCR Assay, issued April 13, 2021;
     LGC, Biosearch Technologies' Biosearch Technologies SARS-
CoV-2 Real-Time and End-Point RT-PCR Test, issued April 15, 2021;
     Synergy Diagnostic Laboratory, Inc.'s (DBA SynergyDx),
SynergyDx SARS-CoV-2 RNA Test, issued April 16, 2021;
     Synergy Diagnostic Laboratory, Inc.'s (DBA SynergyDx),
SynergyDx SARS-CoV-2 RNA Test DTC, issued April 16, 2021;
     Celltrion USA, Inc.'s Celltrion DiaTrust COVID-19 Ag Rapid
Test, issued April 16, 2021;
     Southern California Permanente Medical Group's Kaiser
Permanente High Throughput SARS-CoV-2 Assay, issued April 19, 2021;
     PathogenDx, Inc.'s DetectX-Rv, issued April 20, 2021;
     InBios International, Inc.'s SCoV-2 Ag Detect Rapid Test,
issued May 6, 2021;
     Phosphorus Diagnostics LLC's Phosphorous COVID19 RT-qPCR
Test DTC, issued May 17, 2021;
     Salofa Oy's Sienna-Clarity COVID-19 Antigen Rapid Test
Cassette, issued May 20, 2021;
     Harvard University Clinical Laboratory's Quaeris SARS-CoV-
2 Assay, issued May 21, 2021;
     Thermo Fisher Scientific Inc.'s TaqPath COVID-19 Pooling
Kit, issued May 25, 2021.
    FDA is hereby announcing the following Authorizations for serology
tests: \4\
---------------------------------------------------------------------------

    \4\ As set forth in the EUAs for these products, FDA has
concluded that: (1) SARS-CoV-2 can cause a serious or life-
threatening disease or condition, including severe respiratory
illness, to humans infected by this virus; (2) based on the totality
of scientific evidence available to FDA, it is reasonable to believe
that the products may be effective in diagnosing recent or prior
infection with SARS-CoV-2 by identifying individuals with an
adaptive immune response to the virus that causes COVID-19, and that
the known and potential benefits of the products when used for such
use, outweigh the known and potential risks of the products; and (3)
there is no adequate, approved, and available alternative to the
emergency use of the products.
---------------------------------------------------------------------------

     Abbott Laboratories Inc.'s AdviseDx SARS-CoV-2 IgG II,
issued March 1, 2021;
     Beckman Coulter, Inc.'s Access SARS-CoV-2 IgG II, issued
March 22, 2021;
     Siemens Healthcare Diagnostics Inc.'s Atellica IM SARS-
CoV-2 IgG (sCOVG), issued March 23, 2021;
     Symbiotica, Inc.'s COVID-19 Self-Collected Antibody Test
System, issued April 5, 2021;
     Inova Diagnostics, Inc.'s QUANTA Flash SARS-CoV-2 IgG,
issued April 19, 2021;
     QIAGEN, GmbH's QIAreach Anti-SARS-CoV-2 Total Test, issued
May 11, 2021;
     ZEUS Scientific, Inc.'s ZEUS ELISA SARS-CoV-2 Total
Antibody Test System, issued May 11, 2021;
     DiaSorin, Inc.'s LIAISON SARS-CoV-2 TrimericS IgG, issued
May 19, 2021;
     NOWDiagnostics, Inc.'s ADEXUSDx COVID-19 Test, issued May
24, 2021.
    FDA is hereby announcing the following Authorization for a T-cell
immune response test:
     Adaptive Biotechnologies Corporation's T-Detect COVID
Test, issued March 5, 2021.\5\
---------------------------------------------------------------------------

    \5\ As set forth in the EUA, FDA has concluded that: (1) SARS-
CoV-2 can cause a serious or life-threatening disease or condition,
including severe respiratory illness, to humans infected by this
virus; (2) based on the totality of scientific evidence available to
FDA, it is reasonable to believe that the T-Detect COVID Test may be
effective in diagnosing recent or prior infection with SARS-CoV-2 by
identifying individuals with a T-cell immune response to the virus
that causes COVID-19, and that the known and potential benefits of
your product when used for such use, outweigh the known and
potential risks of the T-Detect COVID Test; and (3) there is no
adequate, approved, and available alternative to the emergency use
of the T-Detect COVID Test.

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

    FDA is hereby announcing the following Authorizations for
multianalyte in vitro diagnostics: \6\
---------------------------------------------------------------------------

    \6\ There are FDA-approved/cleared tests for Influenza A virus
(with subtype differentiation), and other organisms, such as
Influenza B virus, Respiratory Syncytial virus (RSV) A and RSV B,
Coronaviruses 229E, OC43, NL63 and HKU1, Human Metapneumovirus,
Rhinovirus/Enterovirus, Adenovirus, Parainfluenza virus Types 1, 2,
3, and 4, Human Bocavirus, Chlamydophila pneumoniae, and Mycoplasma
pneumoniae but there are no FDA approved/cleared multiplexed tests
for simultaneous qualitative detection and differentiation of SARS-
CoV-2, and these additional pathogens targeted by the products (see
individual EUAs for specific other pathogens). Respiratory
infections caused by the aforementioned pathogens and SARS-CoV-2 can
have similar clinical presentation and diagnostic considerations.
Thus, to differentially detect SARS-CoV-2, information from a test
that detects and differentiates the virus that causes COVID-19 and
other respiratory pathogens is needed. For example, the common
influenza viruses that cause seasonal epidemics of flu, influenza A
and B, is needed during the flu season that coincides with the
COVID-19 pandemic.
---------------------------------------------------------------------------

     Luminex Molecular Diagnostics, Inc.'s NxTAG Respiratory
Pathogen Panel + SARS-CoV-2, issued March 3, 2021; \7\
---------------------------------------------------------------------------

    \7\ As set forth in the EUA, FDA has concluded that: (1) SARS-
CoV-2 can cause a serious or life-threatening disease or condition,
including severe respiratory illness, to humans infected by this
virus; (2) based on the totality of scientific evidence available to
FDA, it is reasonable to believe that the product may be effective
in diagnosing COVID-19, through the simultaneous detection and
differentiation of nucleic acids from SARS-CoV-2 and other
respiratory viral and bacterial organisms and that the known and
potential benefits of the product when used for diagnosing COVID-19,
outweigh the known and potential risks of the product; and (3) there
is no adequate, approved, and available alternative to the emergency
use of the product. The NxTAG Respiratory Pathogen Panel + SARS-CoV-
2 is intended for the simultaneous detection and differentiation of
nucleic acid from SARS- CoV-2 and the following organism types and
subtypes: Influenza A, Influenza A H1, Influenza A H3, Influenza B,
Respiratory Syncytial Virus A, Respiratory Syncytial Virus B,
Coronavirus 229E, Coronavirus OC43, Coronavirus NL63, Coronavirus
HKU1, Human Metapneumovirus, Rhinovirus/Enterovirus, Adenovirus,
Parainfluenza virus 1, Parainfluenza virus 2, Parainfluenza virus 3,
Parainfluenza virus 4, Human Bocavirus, Chlamydophila pneumoniae,
and/or Mycoplasma pneumoniae.
---------------------------------------------------------------------------

     Abbott Molecular Inc.'s Alinity m Resp-4-Plex, issued
March 4, 2021; \8\
---------------------------------------------------------------------------

    \8\ As set forth in the EUA, FDA has concluded that: (1) SARS-
CoV-2 can cause a serious or life-threatening disease or condition,
including severe respiratory illness, to humans infected by this
virus; (2) based on the totality of scientific evidence available to
FDA, it is reasonable to believe that the product may be effective
in diagnosing COVID-19 through the simultaneous detection and
differentiation of SARS-CoV-2, influenza A virus, influenza B virus
and/or RSV nucleic acids and that the known and potential benefits
of the product when used for diagnosing COVID-19, outweigh the known
and potential risks of the product; and (3) there is no adequate,
approved, and available alternative to the emergency use of the
product.
---------------------------------------------------------------------------

     Becton, Dickinson and Company's (BD's) BD Veritor System
for Rapid Detection of SARS-CoV-2 & Flu A+B, issued March 24, 2021; \9\
---------------------------------------------------------------------------

    \9\ As set forth in the EUA, FDA has concluded that: (1) SARS-
CoV-2 can cause a serious or life-threatening disease or condition,
including severe respiratory illness, to humans infected by this
virus; (2) based on the totality of scientific evidence available to
FDA, it is reasonable to believe that the product may be effective
in diagnosing COVID-19 through the simultaneous detection and
differentiation of SARS-CoV-2, and/or influenza A virus and
influenza B virus protein antigens and that the known and potential
benefits of the product when used for such a use, outweigh the known
and potential risks of the product; and (3) there is no adequate,
approved, and available alternative to the emergency use of the
product.
---------------------------------------------------------------------------

     NeuMoDx Molecular, Inc.'s NeuMoDx Flu A-B/RSV/SARS-CoV-2
Vantage Assay, issued March 25, 2021.\10\
---------------------------------------------------------------------------

    \10\ As set forth in the EUA, FDA has concluded that: (1) SARS-
CoV-2 can cause a serious or life-threatening disease or condition,
including severe respiratory illness, to humans infected by this
virus; (2) based on the totality of scientific evidence available to
FDA, it is reasonable to believe that the product may be effective
in diagnosing COVID-19 and that the known and potential benefits of
the product when used for diagnosing COVID-19, outweigh the known
and potential risks of the product; and (3) there is no adequate,
approved, and available alternative to the emergency use of the
product.
---------------------------------------------------------------------------

    FDA is hereby announcing the following Authorizations for other
medical devices:
     GetMyDNA's GetMyDNA COVID-19 Test Home Collection Kit,
issued March 9, 2021; \11\
---------------------------------------------------------------------------

    \11\ As set forth in the EUA, FDA has concluded that: (1) SARS-
CoV-2, the virus that causes COVID-19, can cause a serious or life-
threatening disease or condition, including severe respiratory
illness, to humans infected by this virus; (2) based on the totality
of scientific evidence available to FDA, it is reasonable to believe
that the GetMyDNA COVID-19 Test Home Collection Kit may be effective
in diagnosing COVID-19, by serving as an appropriate means to
collect and transport human specimens so that an authorized
laboratory can detect SARS-CoV-2 RNA from the home-collected human
specimen, and that the known and potential benefits of the GetMyDNA
COVID-19 Test Home Collection Kit when used for diagnosing COVID-19,
outweigh the known and potential risks of the GetMyDNA COVID-19 Test
Home Collection Kit; and (3) there is no adequate, approved, and
available alternative to the emergency use of the GetMyDNA COVID-19
Test Home Collection Kit.
---------------------------------------------------------------------------

     Color Health, Inc.'s Color COVID-19 Self-Swab Collection
Kit DTC, issued March 19, 2021; \12\
---------------------------------------------------------------------------

    \12\ As set forth in the EUA, FDA has concluded that: (1) SARS-
CoV-2, the virus that causes COVID-19, can cause a serious or life-
threatening disease or condition, including severe respiratory
illness, to humans infected by this virus; (2) based on the totality
of scientific evidence available to FDA, it is reasonable to believe
that the Color COVID-19 Self-Swab Collection Kit DTC may be
effective in diagnosing COVID-19, by serving as an appropriate means
to collect and transport human specimens so that an authorized
laboratory can detect SARS-CoV-2 RNA from the home-collected human
specimen, and that the known and potential benefits of the Color
COVID-19 Self-Swab Collection Kit DTC when used for diagnosing
COVID-19, outweigh the known and potential risks of the Color COVID-
19 Self-Swab Collection Kit DTC; and (3) there is no adequate,
approved, and available alternative to the emergency use of the
Color COVID-19 Self-Swab Collection Kit DTC.
---------------------------------------------------------------------------

     Tiger Tech Solutions, Inc.'s Tiger Tech COVID Plus
Monitor, issued March 19, 2021.\13\
---------------------------------------------------------------------------

    \13\ As set forth in the EUA, FDA has concluded that: (1) SARS-
CoV-2, the virus that causes COVID-19, can cause a serious or life-
threatening disease or condition, including severe respiratory
illness, to humans infected by this virus; (2) based on the totality
of scientific evidence available to FDA, it is reasonable to believe
that the Tiger Tech COVID Plus Monitor, when used by trained
personnel, may be effective at preventing exposure to and spread of
SARS-CoV-2 by identifying certain biomarkers in asymptomatic
individuals over the age of 5, when performed following a
temperature reading that does not meet the criteria for fever in
settings where temperature check is being conducted in accordance
with CDC and local institutional infection prevention and control
guidelines, and that the known and potential benefits of such
product, when used as described in the Scope of Authorization of the
authorization letter, outweigh the known and potential risks; and
(3) there are no adequate, approved, and available alternatives to
the emergency use of the Tiger Tech COVID Plus Monitor.
---------------------------------------------------------------------------

     Inspire Rx, LLC's Inspire Rx, LLC Portable Negative
Pressure Isolation & Procedural Tent System, (referred to as the
``AerosolVE Device''), issued March 29, 2021; \14\
---------------------------------------------------------------------------

    \14\ As set forth in the EUA, FDA has concluded that: (1) SARS-
CoV-2 can cause a serious or life-threatening disease or condition,
including severe respiratory illness, to humans infected by this
virus; (2) based on the totality of scientific evidence available to
FDA, it is reasonable to believe that the AerosolVE Device may be
effective in preventing healthcare provider exposure to pathogenic
biological airborne particulates by providing an extra layer of
barrier protection in addition to personal protective equipment, at
the time of definitive airway management, or when performing airway-
related medical procedures, or during certain transport (when end-
tidal CO2 monitoring is not available) for a maximum
duration of use of 30 minutes, of patients with suspected or
confirmed diagnosis of COVID-19 and that the known and potential
benefits of the AerosolVE Device for such use outweigh its known and
potential risks; and (3) there is no adequate, approved, and
available alternative to the emergency use of the AerosolVE Device.
During the public health emergency, it would not be feasible to
require healthcare providers to limit use of the AerosolVE Device to
patients with suspected or confirmed COVID-19; therefore, the
authorization does not restrict use to such patients.
---------------------------------------------------------------------------

     J. Peter Rubin, MD, MBA, FACS at the University of
Pittsburgh's Individual Biocontainment Unit (``IBU''), issued April 1,
2021; \15\
---------------------------------------------------------------------------

    \15\ As set forth in the EUA, FDA has concluded that: (1) SARS-
CoV-2 can cause a serious or life-threatening disease or condition,
including severe respiratory illness, to humans infected by this
virus; (2) based on the totality of scientific evidence available to
FDA, it is reasonable to believe that the IBU may be effective in
preventing healthcare provider exposure to pathogenic biological
airborne particulates by providing an extra layer of barrier
protection in addition to personal protective equipment, at the time
of definitive airway management, or when performing medical
procedures, or during transport of patients with suspected or
confirmed diagnosis of COVID-19 and that the known and potential
benefits of the IBU for such use outweigh its known and potential
risks; and (3) there are no adequate, approved, and available
alternatives to the emergency use of the IBU. During the public
health emergency, it would not be feasible to require healthcare
providers to limit the IBU use for patients with suspected or
confirmed COVID-19; therefore, the authorization does not restrict
use to such patients.

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

     Yale School of Public Health, Department of Epidemiology
of Microbial Diseases' SalivaDirect At-Home Collection Kit, issued
April 9, 2021; \16\
---------------------------------------------------------------------------

    \16\ As set forth in the EUA, FDA has concluded that: (1) SARS-
CoV-2, the virus that causes COVID-19, can cause a serious or life-
threatening disease or condition, including severe respiratory
illness, to humans infected by this virus; (2) based on the totality
of scientific evidence available to FDA, it is reasonable to believe
that the SalivaDirect At-Home Collection Kit may be effective in
diagnosing COVID-19, by serving as an appropriate means to collect
and transport human specimens so that an authorized laboratory can
detect SARS-CoV-2 RNA from the self-collected human specimen, and
that the known and potential benefits of the SalivaDirect At-Home
Collection Kit when used for diagnosing COVID-19, outweigh the known
and potential risks of the SalivaDirect At-Home Collection Kit; and
(3) there is no adequate, approved, and available alternative to the
emergency use of the SalivaDirect At-Home Collection Kit.
---------------------------------------------------------------------------

     Color Health, Inc.'s Color COVID-19 Self-Swab Collection
Kit with Saline, issued April 14, 2021; \17\
---------------------------------------------------------------------------

    \17\ As set forth in the EUA, FDA has concluded that: (1) SARS-
CoV-2, the virus that causes COVID-19, can cause a serious or life-
threatening disease or condition, including severe respiratory
illness, to humans infected by this virus; (2) based on the totality
of scientific evidence available to FDA, it is reasonable to believe
that the Color COVID-19 Self-Swab Collection Kit with Saline may be
effective in diagnosing COVID-19, by serving as an appropriate means
to collect and transport human specimens so that an authorized
laboratory can detect SARS-CoV-2 RNA from the self-collected human
specimen, and that the known and potential benefits of the Color
COVID-19 Self-Swab Collection Kit with Saline when used for
diagnosing COVID-19, outweigh the known and potential risks of the
Color COVID-19 Self-Swab Collection Kit with Saline; and (3) there
is no adequate, approved, and available alternative to the emergency
use of the Color COVID-19 Self-Swab Collection Kit with Saline.
---------------------------------------------------------------------------

     Prep Tech, LLC's ISOCUBE SS and ISOCUBE ONE (``ISOCUBE''),
issued May 4, 2021; \18\
---------------------------------------------------------------------------

    \18\ As set forth in the EUA, FDA has concluded: (1) SARS-CoV-2
can cause a serious or life-threatening disease or condition,
including severe respiratory illness, to humans infected by this
virus; (2) based on the totality of scientific evidence available to
FDA, it is reasonable to believe that ISOCUBE may be effective in
preventing healthcare provider exposure to pathogenic biological
airborne particulates by providing an extra layer of barrier
protection in addition to personal protective equipment, at the time
of definitive airway management, or when performing airway-related
medical procedures, or during certain transport of patients with
suspected or confirmed diagnosis of COVID-19 and that the known and
potential benefits of ISOCUBE for such use outweigh its known and
potential risks; and (3) there are no adequate, approved, and
available alternatives to the emergency use of the ISOCUBE. During
the public health emergency, it would not be feasible to require
healthcare providers to limit the ISOCUBE use for patients with
suspected or confirmed COVID-19; therefore, the authorization does
not restrict use to such patients.
---------------------------------------------------------------------------

     Breegi Scientific, Inc.'s Negative Pressure SteriDome
(NPS), issued May 6, 2021; \19\
---------------------------------------------------------------------------

    \19\ As set forth in the EUA, FDA has concluded: (1) SARS-CoV-2
can cause a serious or life-threatening disease or condition,
including severe respiratory illness, to humans infected by this
virus; (2) based on the totality of scientific evidence available to
FDA, it is reasonable to believe that the NPS may be effective in
preventing healthcare provider exposure to pathogenic biological
airborne particulates by providing an extra layer of barrier
protection in addition to personal protective equipment, at the time
of definitive airway management, when performing airway-related
medical procedures, or during certain transport for a maximum
duration of use of 1 hour, of patients with suspected or confirmed
diagnosis of COVID-19 and that the known and potential benefits of
the NPS for such use outweigh its known and potential risks; and (3)
there are no adequate, approved, and available alternatives to the
emergency use of the NPS. During the public health emergency, it
would not be feasible to require healthcare providers to limit use
of the NPS to patients with suspected or confirmed COVID-19;
therefore, the authorization does not restrict use to such patients.
---------------------------------------------------------------------------

     Phosphorus Diagnostics LLC's Pinpoint by Phosphorus COVID-
19 Test Home Collection Kit DTC, issued May 17, 2021.\20\
---------------------------------------------------------------------------

    \20\ As set forth in the EUA, FDA has concluded that: (1) SARS-
CoV-2, the virus that causes COVID-19, can cause a serious or life-
threatening disease or condition, including severe respiratory
illness, to humans infected by this virus; (2) based on the totality
of scientific evidence available to FDA, it is reasonable to believe
that the Pinpoint by Phosphorus COVID-19 Test Home Collection Kit
DTC may be effective in diagnosing COVID-19, by serving as an
appropriate means to collect and transport human specimens so that
an authorized laboratory can detect SARS-CoV-2 RNA from the self-
collected human specimen, and that the known and potential benefits
of the Pinpoint by Phosphorus COVID-19 Test Home Collection Kit DTC
when used for diagnosing COVID-19, outweigh the known and potential
risks of the Pinpoint by Phosphorus COVID-19 Test Home Collection
Kit DTC; and (3) there is no adequate, approved, and available
alternative to the emergency use of the Pinpoint by Phosphorus
COVID-19 Test Home Collection Kit DTC.
---------------------------------------------------------------------------

    Finally, FDA is hereby announcing an amendment to certain EUAs to
allow certain authorized molecular diagnostic SARS-CoV-2 tests to be
distributed and used to pool anterior nasal respiratory specimens from
asymptomatic individuals as part of a serial testing program after
developers submit a complete notification, including meeting required
validation data, as set forth in the amendment letter. The amendment
``Amending Certain EUAs for RT-PCR Molecular-Based Diagnostic Tests to
Authorize the Detection of Nucleic Acid from SARS-CoV-2 from Pooled
Anterior Nasal Respiratory Specimens for Screening When Used as Part of
a Serial Testing Program,'' was issued to ``Developers of Molecular-
Based Diagnostic Tests Authorized for Emergency Use for Coronavirus
Disease 2019 (COVID-19) as of Today's Date'' on April 20, 2021.\21\
---------------------------------------------------------------------------

    \21\ As set forth in the amendment, FDA has concluded (1) SARS-
CoV-2 can cause a serious or life-threatening disease or condition,
including severe respiratory illness, to humans infected by this
virus, (2) based on the totality of scientific evidence available to
FDA, it is reasonable to believe that the authorized tests may be
effective in diagnosing COVID-19 for the indications set forth in
the appendices of the amendment letter, and that the known and
potential benefits of the authorized tests when used for such use,
outweigh the known and potential risks of the authorized tests
included in the amendment; and (3) there are no adequate, approved,
and available alternatives to the emergency use of the authorized
tests included in the amendment.

    Dated: July 16, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-15680 Filed 7-22-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 76, Number 196 (Tuesday, October 11, 2011)]
[Notices]
[Pages 62879-62881]
[FR Doc No: 2011-26138]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-65482; File No. SR-C2-2011-028]

Self-Regulatory Organizations; C2 Options Exchange, Incorporated:
Notice of Filing and Immediate Effectiveness of Proposed Rule
ChangeRelating to PULSe Fees

October 4, 2011.
    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 October 3, 2011, C2 Options Exchange, Incorporated
(``Exchange'' or ``C2'') 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 Exchange has designated this proposal as one establishing
or changing a due, fee, or other charge imposed by the Exchange under
Section 19(b)(3)(A)(ii) of the Act \3\ and Rule 19b-4(f)(2)
thereunder.\4\ 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.
    \3\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \4\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

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

    The Exchange is proposing to amend its Fees Schedule as it relates
to the PULSe workstation. The text of the proposed rule change is
available on the Exchange's Web site (http://www.c2exchange.com), at
the Exchange's Office of the Secretary and at the Commission.

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 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, Proposed Rule Change

1. Purpose
    The purpose of this proposed rule change is to adopt a PULSe
routing fee for executions of orders on C2 that originate from non-
Trading Permit Holder (``TPH'') PULSe workstations. The Exchange is
also proposing some non-substantive changes to the fees schedule text
to clarify the existing operation of the Routing Intermediary fee.
These changes, which are described in more detail below, will be
effective October 3, 2011.\5\
---------------------------------------------------------------------------

    \5\ See e-mail from Jennifer M. Lamie, Assistant Secretary, C2,
to Steve L. Kuan, Attorney, Division of Trading and Markets,
Commission, on October 3, 2011.
---------------------------------------------------------------------------

    By way of background, the PULSe workstation is a front-end order
entry system designed for use with respect to orders that may be sent
to the trading systems of C2. In addition, the PULSe workstation
provides a user with the capability to send options orders to other
U.S. options exchanges and stock orders to other U.S. stock exchanges
and trading centers (``away market routing'').\6\ To use the away-
market routing functionality, a C2 TPH must either be a PULSe Routing
Intermediary or establish a relationship with a third party PULSe
Routing Intermediary. A ``PULSe Routing Intermediary'' is a C2 TPH that
has connectivity to, and is a member of, other options and/or stock
exchanges and trading centers. If a TPH sends an order from the PULSe
workstation, the PULSe Routing Intermediary will route that order to
the designated market on behalf of the entering TPH.\7\
---------------------------------------------------------------------------

    \6\ For a more detailed description of the PULSe workstation and
its other functionalities, see, e.g., Securities Exchange Act
Release Nos. 63246 (November 4, 2010), 75 FR 69478 (November 12,
2010) (SR-C2-2010-007) and 65279 (September 7, 2011), 76 FR 56824
(September 14, 2011) (SR-C2-2011-020).
    \7\ The PULSe workstation offers the ability to route orders to
any market including, among others, C2 affiliates Chicago Board
Options Exchange, Incorporated (``CBOE'') and CBOE Stock Exchange,
LLC (``CBSX,'' CBOE's stock execution facility). To the extent a C2
TPH that is also a CBOE/CBSX TPH obtains a PULSe workstation through
CBOE, it is not necessary for that TPH to obtain a separate PULSe
workstation through CBOE or CBSX to route orders to CBOE or CBSX, as
applicable. See, e.g., SR-C2-2010-007, note 5, supra. It is also not
necessary for that TPH to utilize the services of a Routing
Intermediary to route orders to CBOE or CBSX, as applicable. As
such, to the extent a C2 TPH is also a CBOE TPH or a CBSX TPH, the
``Away-Market Routing'' and ``Routing Intermediary'' fees detailed
in the Exchange Fees Schedule are not be applicable because the fees
are only applicable for away-market routing. The TPH would not be
away-market routing, but instead would be submitting orders directly
to C2 as a C2 TPH, CBOE as a CBOE TPH or CBSX as a CBSX TPH, as
applicable, where the TPH's activity would be subject to the
transaction fee schedule of C2, CBOE or CBSX, respectively. To the
extent a C2 TPH is not a CBOE TPH or a CBSX TPH, the Away-Market
Routing and Routing Intermediary fees would apply for the TPH's
executions on CBOE or CBSX, as applicable.
---------------------------------------------------------------------------

    The first purpose of this proposed rule change is to adopt a C2
Routing fee. This fee would be payable by a TPH that makes the PULSe
workstation available to non-TPHs and would only be applicable for
routing to C2 from such non-TPH PULSe workstations. The fee would be
$0.02 per contract or share equivalent for the first 1 million
contracts or share equivalent executed in a month on C2 that originate
from non-TPH PULSe workstations made available by the TPH, and $0.03
per contract or share equivalent for each additional contract or share
equivalent executed on C2 in the same month from the non-TPH PULSe
workstations made available by the TPH.\8\
---------------------------------------------------------------------------

    \8\ The Exchange notes that CBOE is submitting a similar rule
change to introduce a ``CBOE/CBSX Routing'' fee that will be
applicable to CBOE TPHs and CBSX TPHs. See SR-CBOE-2011-092. To the
extent that a C2 TPH making the non-TPH PULSe workstations available
is not also a CBOE TPH or a CBSX TPH, routing from the non-TPH
workstations to CBOE or CBSX would not be considered ``CBOE/CBSX
Routing'' and, therefore, would not be subject to that fee (it would
instead be considered ``away-market routing'' and subject to the
Away-Market Routing and Routing Intermediary fees described above).
To the extent that a C2 TPH making the non-TPH PULSe workstations
available is also a CBOE TPH or CBSX TPH, routing from the non-TPH
workstations to CBOE or CBSX would be considered ``CBOE/CBSX
Routing'' and therefore would be subject to that fee.
    Example 1: Assume a C2 TPH that is not a CBOE TPH makes a PULSe
workstation available to Non-TPH User A. To the extent that orders
originating from Non-TPH User A's PULSe workstation are routed to
C2, any resulting executions would be subject to the C2 Routing fee.
To the extent that orders originating from Non-TPH User A's PULSe
workstation are routed to CBOE, any resulting executions would be
considered away-market routing and subject to the Away-Market
Routing and Routing Intermediary fees (and not subject to the CBOE/
CBSX Routing fee).
    Example 2: Assume a C2 TPH that is also a CBOE TPH makes a PULSe
workstation available to Non-TPH User A. To the extent that orders
originating from Non-TPH User A's PULSe workstation are routed to
C2, any resulting executions would be subject to the C2 Routing fee.
To the extent that orders originating from Non-TPH User A's PULSe
workstation are routed to CBOE, any resulting executions would be
subject to the CBOE/CBSX Routing fee. (Given the C2 TPH's status as
a CBOE TPH, such orders are not considered away-market routing and
therefore are not subject to the Away-Market Routing and Routing
Intermediary fees.)

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

    The C2 Routing fee will allow for the recoupment of the costs of
developing, maintaining, and supporting the PULSe workstation and for
income from the value-added services being provided through use of the
PULSe workstation. The Exchange believes the fee structure represents
an equitable allocation of reasonable fees in that the same fees will
be applicable to all TPHs that make PULSe workstations available to
non-TPHs. The Exchange also believes that the establishment of the fee,
which is payable by TPHs only for transactions originating from non-TPH
workstations, is equitable and not unfairly discriminatory because non-
TPHs are able to obtain the benefits of utilizing the PULSe
workstation--including the ability to route orders to the Exchange--
without becoming a TPH (and incurring the associated costs of TPH
membership). In addition, the Exchange believes that the $0.02/$0.03 C2
Routing fee is reasonable and appropriate in light of the facts that it
is small in relation to the total costs typically incurred in routing
and executing orders and that the amount is comparable to the
Exchange's existing Routing Intermediary fee for away-market routing.
The Exchange notes that the lower $0.02 rate for the first 1 million
contracts or share equivalent (as compared to the $0.03 rate for each
additional contract or share equivalent) is reasonable in that it is
designed to help attract and encourage use of the PULSe workstation.
The Exchange also notes that use of the PULSe workstation, and the
routing technology available through the PULSe workstation, are not
compulsory. The service is offered as a convenience and is not the
exclusive means available to send or route orders to C2 (or another
market).
    The second purpose of this proposed rule change is to revise and
expand on the description in the Fees Schedule text of the ``Routing
Intermediary'' fee.\9\ In particular, the Exchange is renaming the fee
from ``Routing Intermediary'' fee to ``Away-Market Routing
Intermediary'' fee. Because this fee is only applicable when a Routing
Intermediary is routing to away markets, the Exchange believes this
change in title will be more descriptive and helpful to persons reading
the Fees Schedule. Likewise, the Exchange is expanding on the
description in the text to make clear that the ``Away-Market Routing
Intermediary'' fee is payable by a Routing Intermediary and is only
applicable for away-market routing from any PULSe workstation. The
expanded description also makes clear that the fee rates are determined
based on the aggregate level of transactions across all away-markets
and across all PULSe workstations for which firm serves as the Routing
Intermediary. This level of detail on the meaning and application of
the fee was previously included in the discussion section of prior rule
filings and is consistent with the Exchange's original intent and
understanding the fee structure.\10\ The Exchange is simply proposing
to include the clarifying information within the text of the Fees
Schedule.
---------------------------------------------------------------------------

    \9\ This fee is currently $0.02 per contract or share equivalent
for the first 1 million contracts or share equivalent executed in a
month and $0.03 per contract or share equivalent for each additional
contract or share equivalent executed in the same month.
    \10\ See, e.g., SR-C2-2011-020, note 5, supra.
---------------------------------------------------------------------------

2 Statutory Basis
    The proposed rule change is consistent with Section 6(b) of the
Act,\11\ in general, and furthers the objectives of Section 6(b)(4) of
the Act,\12\ in particular, in that it is designed to provide for the
equitable allocation of reasonable dues, fees, and other charges among
TPHs in that the same fees are applicable to all TPHs that utilize the
PULSe workstation or make it available to non-TPHs.
---------------------------------------------------------------------------

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

    With respect to the C2 Routing fee in particular, the Exchange
believes that the establishment of the C2 Routing fee, which is payable
by TPHs only for transactions originating from non-TPH workstations, is
equitable and not unfairly discriminatory because, from the TPH
perspective, as indicated above, the same fees are applicable to all
TPHs that make the PULSe workstation available to non-TPHs. In
addition, because non-TPHs are able to obtain the benefits of utilizing
the PULSe workstation--including the ability to route orders to the
Exchange--without becoming a TPH (and incurring the associated costs of
TPH membership), the Exchange believes it is equitable and not unfairly
discriminatory for the Exchange to assess the C2 Routing fee to TPHs
for executions of orders originating from non-TPH PULSe workstations.
The Exchange believes that the $0.02/$0.03 C2 Routing fee rate itself--
which will allow for the recoupment of the costs of developing,
maintaining, and supporting the PULSe workstation and for income from
the value-added services being provided through use of the PULSe
workstation--is reasonable and appropriate in light of the facts that
it is small in relation to the total costs typically incurred in
routing and executing orders and that the amount is comparable to the
Exchange's existing Routing Intermediary fee for away-market routing.
The Exchange also believes that the lower $0.02 rate for the first 1
million contracts or share equivalent (as compared to the $0.03 rate
for each additional contract or share equivalent) is reasonable in that
it is designed to help attract and encourage use of the PULSe
workstation. Finally, in our consideration that the fee is equitable
and not unfairly discriminatory, the Exchange note that use of the
PULSe workstation, and the routing technology available through the
PULSe workstation, are not compulsory. The service is offered as a
convenience and is not the exclusive means available to send or route
orders to C2 (or another market).

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

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

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

    No written comments were solicited or received with respect to the
proposed rule change.

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

    The proposed rule change is designated by the Exchange as
establishing or changing a due, fee, or other charge, thereby
qualifying for

effectiveness on filing pursuant to Section 19(b)(3)(A)(ii) of the Act
\13\ and subparagraph (f)(2) of Rule 19b-4\14\ thereunder.
---------------------------------------------------------------------------

    \13\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \14\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

    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.

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 e-mail to<EMAIL_ADDRESS>Please include
File Number SR-C2-2011-028 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-C2-2011-028. 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, 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 such 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-C2-2011-028 and should be
submitted on or before November 1, 2011.
---------------------------------------------------------------------------

    \15\ 17 CFR 200.30-3(a)(12).

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

Elizabeth M. Murphy,
Secretary.
[FR Doc. 2011-26138 Filed 10-7-11; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 77, Number 14 (Monday, January 23, 2012)]
[Notices]
[Pages 3308-3310]
[FR Doc No: 2012-1238]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-66172; File No. SR-ISE-2012-03]

Self-Regulatory Organizations; International Securities Exchange,
LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule
Change Relating to Fees and Rebates for Adding and Removing Liquidity

January 18, 2012.
    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 January 5, 2012, the International Securities Exchange, LLC
(the ``Exchange'' or the ``ISE'') filed with the Securities and
Exchange Commission (the ``Commission'') the proposed rule change as
described in Items I and II 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 ISE is proposing to amend its transaction fees and rebates for
adding and removing liquidity. The text of the proposed rule change is
available on the Exchange's Web site (http://www.ise.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 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 IV 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
    The Exchange currently assesses per contract transaction fees and
rebates to market participants that add or remove liquidity from the
Exchange (``maker/taker fees'') in a number of options classes (the
``Select Symbols'').\3\ The purpose of this proposed rule change is to
amend the list of Select Symbols on the Exchange's Schedule of Fees,
titled ``Rebates and Fees for Adding and Removing Liquidity in Select
Symbols and Complex Order Maker/Taker fees for symbols that are in the
Penny Pilot Program'' in order to attract additional order flow to the
Exchange. The Exchange is proposing to delete AMR Corporation (``AMR'')
from the list of Select Symbols. With this proposed rule change, AMR
will no longer be subject to the Exchange's maker/taker fees.
---------------------------------------------------------------------------

    \3\ Options classes subject to maker/taker fees are identified
by their ticker symbol on the Exchange's Schedule of Fees.
---------------------------------------------------------------------------

    The Exchange also proposes to make a non-substantive, clarifying
change to page 21 of the Schedule of Fees, titled ``Rebates and Fees
for Adding and Removing Liquidity for complex orders in NDX and RUT.''
The Exchange recently adopted fees and rebates for complex orders in
NDX and RUT \4\ and now proposes to clarify that the $0.50 per contract
rebate payable to Priority Customer complex orders when these orders
trade with non-customer orders in the Complex Order Book is applicable
only to complex orders in NDX and RUT by deleting the words ``in the
Select Symbols'' from footnote 2 on page 21 of the Schedule of Fees.
---------------------------------------------------------------------------

    \4\ See Securities Exchange Act Release No. 66084 (January 3,
2012) (SR-ISE-2011-84).
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that its proposal to amend its Schedule of
Fees is consistent with Section 6(b) of the Act \5\ in general, and
furthers the objectives of Section 6(b)(4) of the Act \6\ in
particular, in that it is an equitable allocation of reasonable fees
and other charges among Exchange members and other persons using its
facilities.
---------------------------------------------------------------------------

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

    The Exchange believes that it is reasonable to remove AMR from its
list of Select Symbols to attract additional order flow to the
Exchange. The Exchange believes that applying non-maker/taker fees to
AMR, including the opportunity to receive payment for order flow, will
attract order flow in AMR to the Exchange.
    The Exchange believes that it is equitable and not unfairly
discriminatory to amend its list of Select Symbols to remove AMR
because the list of Select Symbols would apply uniformly to all
categories of participants in the same manner. All market participants
who trade the Select Symbols would be subject to the maker/taker fees
and rebates, which would not include AMR. Also, all market participants
would be uniformly subject to the non-maker/taker fees, which would
include AMR.
    Finally, the Exchange believes that clarifying that the rebate
payable to Priority Customer complex orders when these orders trade
with non-customer orders in the Complex Order Book is applicable only
to complex orders in NDX and RUT is equitable and reasonable because it
clarifies the applicability of the rebate.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Act.\7\ At any time within 60 days of the filing
of such proposed rule change, the Commission summarily may temporarily
suspend such rule change if it appears to the Commission that such
action is necessary or appropriate in the public interest, for the
protection of investors, or otherwise in furtherance of the purposes of
the Act. If the Commission takes such action, the Commission shall
institute proceedings to determine whether the proposed rule should be
approved or disapproved.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78s(b)(3)(A)(ii).
---------------------------------------------------------------------------

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-ISE-2012-03 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-2012-03. 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
a.m. and 3 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-ISE-2012-03 and should be
submitted on or before February 13, 2012.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\8\
---------------------------------------------------------------------------

    \8\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-1238 Filed 1-20-12; 8:45 am]
BILLING CODE 8011-01-P