[Federal Register Volume 76, Number 218 (Thursday, November 10, 2011)]
[Notices]
[Pages 70151-70152]
[FR Doc No: 2011-29118]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0790]

Draft Guidance for Industry, Clinical Investigators,
Institutional Review Boards, and Food and Drug Administration Staff;
Food and Drug Administration Decisions for Investigational Device
Exemption Clinical Investigations; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the draft guidance entitled ``FDA Decisions for
Investigational Device Exemption (IDE) Clinical Investigations.'' This
guidance document has been developed to promote the initiation of
clinical investigations to evaluate medical devices under FDA's IDE
regulations. In an effort to promote timely clinical investigations in
a manner that protects study subjects, FDA has developed methods to
allow a clinical investigation to begin under certain circumstances,
even when there are outstanding issues regarding the IDE submission.
These mechanisms, including approval with conditions, staged approval
or staged approval with conditions, and communication of outstanding
issues related to the IDE through future considerations, are described
in this guidance.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by February 8, 2012.

ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``FDA Decisions for Investigational Device
Exemption (IDE) Clinical Investigations'' to the Division of Small
Manufacturers, International and Consumer Assistance, Center for
Devices and Radiological Health, Food

and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 4613,
Silver Spring, MD 20993-0002; or to the Office of Communication,
Outreach and Development (HFM-40), Center for Biologics Evaluation and
Research (CBER), Food and Drug Administration, 1401 Rockville Pike,
Rockville, MD 20852-1448. Send one self-addressed adhesive label to
assist that office in processing your request, or fax your request to
(301) 847-8149. See the SUPPLEMENTARY INFORMATION section for
information on electronic access to the guidance.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Identify comments with the docket number
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:

Owen Faris, Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 1108, Silver
Spring, MD 20993-0002,<PHONE_NUMBER>; or

Stephen Ripley, Center for Biologics Evaluation and Research (HFM-17),
Food and Drug Administration, 1401 Rockville Pike, suite 200N,
Rockville, MD 20852,<PHONE_NUMBER>.

I. Background

    FDA approval of an IDE submission allows the initiation of a
clinical investigation of a significant risk device. This guidance is
intended to provide clarification regarding the regulatory implications
of the decisions that FDA may render based on review of an IDE and to
provide a general explanation of the reasoning and implications of
those decisions. FDA has traditionally referred to IDE approvals that
have conditions as ``Conditional Approvals.'' FDA believes that the
term ``Approval with Conditions'' is more appropriate because the term
conveys that the IDE has been approved and may begin without awaiting
further FDA review. An IDE may be approved with conditions if FDA has
determined, despite outstanding issues, that the information provided
is sufficient to justify human clinical evaluation of the device, and
that the proposed study design is generally acceptable. FDA may now
also include ``future considerations'' in an approval or approval with
conditions letter, which are issues and recommendations that FDA
believes the sponsor should consider in preparation for a marketing
application or a future clinical investigation. Future considerations
are intended to provide helpful advice to sponsors regarding important
elements of the future application that the IDE may not specifically
address.
    In this guidance new mechanisms are introduced, termed ``stage
approval'' and ``staged approval with conditions,'' by which FDA may
grant IDE approval or approval with conditions, while certain
outstanding questions are being answered in parallel with enrollment in
the clinical investigation. Staged approval and staged approval with
conditions permit the clinical investigation to begin in a timely
manner while maintaining appropriate subject protections. Staged
approval or staged approval with conditions is most common for pivotal
studies in which many subjects will be enrolled over an extended period
of time, but may be applicable to other clinical investigations as
well.
    As a result of this draft guidance, FDA, where appropriate, seeks
to offer flexibility in how outstanding issues can be addressed to
allow clinical investigations to commence without unnecessary delay,
while ensuring that human subjects are adequately protected.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the Agency's current thinking on ``FDA
Decisions for Investigational Device Exemption (IDE) Clinical
Investigations.'' It does not create or confer any rights for or on any
person and does not operate to bind FDA or the public. An alternative
approach may be used if such approach satisfies the requirements of the
applicable statute and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do
so by using the Internet. A search capability for all CDRH guidance
documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at http://www.regulations.gov or from the
CBER Internet site at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm. To receive ``FDA
Decisions for Investigational Device Exemption (IDE) Clinical
Investigations'' you may either send an email request to
<EMAIL_ADDRESS>to receive an electronic copy of the document or
send a fax request to<PHONE_NUMBER> to receive a hard copy. Please use
the document number 1783 to identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 812 have been approved under
OMB control number 0910-0078.

V. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES), either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: November 4, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-29118 Filed 11-9-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 86, Number 169 (Friday, September 3, 2021)]
[Rules and Regulations]
[Pages 49482-49484]
[FR Doc No: 2021-19005]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 62

[EPA-R02-OAR-2018-0564, FRL 8921-02-Region 2]

Approval and Promulgation of State Plans for Designated
Facilities; New York

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is approving the
state plan submitted by New York State to implement and enforce
Emission Guidelines (EG) for existing large municipal waste combustor
(MWC) units. The state plan is consistent with the amended EG
promulgated by the EPA on May 10, 2006. New York's plan establishes
emission limits and other requirements for the purpose of reducing
emissions of lead, mercury, cadmium, organics, hydrogen chloride, and
other air pollutants from large MWC units throughout the state. New
York submitted its plan to fulfill the requirements of certain sections
of the Clean Air Act.

DATES: This rule is effective on October 4, 2021. The incorporation by
reference of certain materials listed in the rule is approved by the
Director of the Federal Register as of October 4, 2021.

ADDRESSES: The EPA has established a docket for this action under
Docket ID No. EPA-R02-OAR-2018-0564. All documents in the docket are
listed on the http://www.regulations.gov website. Although listed in
the index, some information is not publicly available, e.g.,
confidential business information or other information whose disclosure
is restricted by statute. Certain other material, such as copyrighted
material, is not placed on the internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available through www.regulations.gov, or please contact the person
identified in the FOR FURTHER INFORMATION CONTACT section for
additional available information.

FOR FURTHER INFORMATION CONTACT: Fausto Taveras, Air Programs Branch,
290 Broadway, 25th Floor, New York, New York 10007-1866, (212) 637-
3378, or by email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The following table of contents describes
the format for the SUPPLEMENTARY INFORMATION section:

I. What action is the EPA taking?
II. What are the details of the EPA's action?
III. What comments were received in response to the EPA's proposed
action?
IV. What is the EPA's conclusion?
V. Incorporation by Reference
VI. Statutory and Executive Order Reviews

I. What action is the EPA taking?

    The EPA is approving New York's revised state plan, submitted on
July 12, 2013, for the control of air emissions from existing large
municipal waste combustor (MWC) units throughout the state, except for
any existing large MWC units located in Indian Nation Land. In
accordance with the Clean Air Act (``CAA'' or the ``Act''), New York
previously submitted a state plan on December 15, 1997, as supplemented
on June 22, 1998, which was approved by the EPA on August 4, 1998. See
63 FR 41427. New York also submitted a revised state plan on October 7,
1998, as supplemented on November 5, 1998, which was approved by the
EPA on February 9, 1999. See 64 FR 6237. New York submitted its July
12, 2013 revised plan to fulfill the requirements of sections 111(d)
and 129 of the CAA. The revised state plan adopts and implements the
Emission Guidelines (EG) amended by the EPA on May 10, 2006 applicable
to existing large MWC units and establishes revised emission limits and
other requirements for units constructed on or before September 20,
1994. See 71 FR 27324 (May 10, 2006); 40 CFR 60.32b(a). New York's
revised state plan regulates all the existing units designated as large
MWCs by the amended EG with a combustion capacity greater than 250 tons
per day of municipal solid waste for which construction commenced on or
before September 20, 1994. This approval, once effective, will render
New York's revised large MWC rules included in the state plan federally
enforceable.

II. What are the details of the EPA's action?

    On July 12, 2013,\1\ the New York State Department of Environmental
Conservation (NYSDEC) submitted to the EPA its sections 111(d) and 129
state plan to implement the EPA's amended EG for existing large MWC
units located in New York state. New York has incorporated by reference
the applicable requirements of the amended EG in Part 200 of Title 6 of
the New York Codes, Rules and Regulations (6 NYCRR), entitled,
``General Provisions.'' The amended regulation became effective on
October 20, 2007. New York will enforce the requirements under Part
201, entitled ``Permits and Registration.'' By incorporating the
requirements of the amended EG into Part 200, NYSDEC has the authority
to include them as applicable requirements in the permits of subject
emission sources. As a result, the Part 200 requirements are
enforceable by New York and become federally enforceable once the state
plan is approved by the EPA.
---------------------------------------------------------------------------

    \1\ In an email dated December 6, 2017, the New York State
Department of Environmental Conservation (NYSDEC) provided a copy of
the New York State Office of Attorney General opinion dated June 9,
1980, finding that New York state administrative agencies are
authorized to incorporate by reference federal statutes and
regulations that are applicable to the state, and that such action
is not prohibited by the New York State Constitution.
---------------------------------------------------------------------------

    New York's revised state plan includes all of the EPA's required
elements as described in the amended EG and 40 CFR subpart B, as
summarized herein:
    (1) A demonstration of the state's legal authority to implement the
CAA sections 111(d) and 129 state plan;

    (2) State rules adopting the amended EG (6 NYCRR Part 200) as the
mechanism for implementing and enforcing the state plan;
    (3) An inventory of seven known large MWC facilities, including
eighteen large MWC units, along with an inventory of their air
pollutant emissions (see section C of New York's state plan);
    (4) Emission limits, emission standards, operator training and
qualification requirements, and operating limits that are at least as
protective as the amended EG;
    (5) Enforceable compliance schedules as indicated in the amended
EG. Compliance with revised emission limits (see 40 CFR 60.39b) was
required as expeditiously as practicable, but not later than April 28,
2009, except as noted in 40 CFR 60.39b(g)(2) for a facility that was
planning an extensive emission control system upgrade that petitioned
the Administrator for a longer compliance schedule. If approved by the
Administrator, the longer compliance schedule may have been extended no
later than May 10, 2011. If no plan for implementing the amended EG was
approved by the EPA, all MWC units that meet the applicability
standards set forth in 40 CFR 60.32b must have been in compliance with
all requirements of the amended EG no later than May 10, 2011 (see 40
CFR 60.39b(h)).
    (6) Testing, monitoring, reporting, and recordkeeping requirements
for the designated facilities;
    (7) Records of the public hearing on the revised state plan; and,
    (8) Provisions for annual state progress reports to the EPA on
implementation of the revised state plan.
    The EPA reviewed New York's revised state plan for approval against
the following criteria: 40 CFR 60.23 through 60.26, ``Subpart B--
Adoption and Submittal of State Plans for Designated Facilities,''
``Subpart Cb--Emissions Guidelines and Compliance Times for Large
Municipal Waste Combustors That are Constructed on or Before September
20, 1994,'' and 40 CFR part 62 subpart A, ``General Provisions'' for
``Approval and Promulgation of State Plans for Designated Facilities
and Pollutants.''
    On September 10, 2018 (see 83 FR 45589), the EPA proposed to
determine that New York's revised state plan for large MWC units
includes all the required state plan elements described in the amended
EG and, therefore, the EPA proposed approval of New York's July 12,
2013 state plan submittal.

III. What comments were received in response to the EPA's proposed
action?

    In response to the EPA's September 10, 2018 (see 83 FR 45589)
proposed rulemaking on New York's state plan submission for existing
large MWCs, the EPA received two comments during the 30-day public
comment period. The first public comment, posted on October 9, 2018,
supports the EPA's proposed rulemaking to approve New York's state
plan. Also, the EPA has determined that the second public comment,
posted on October 17, 2018, is outside the scope of our proposed action
and fails to identify any material issue necessitating a response. The
second public comment does not raise any issues germane to the EPA's
proposed action. For these reasons, the EPA will not provide a specific
response to the second public comment. The specific public comments may
be viewed under Docket ID Number EPA-R02-OAR-2018-0564 on the http://www.regulations.gov website.

IV. What is the EPA's conclusion?

    The EPA has determined that New York's revised state plan meets all
the applicable approval criteria as discussed above and, therefore, the
EPA is approving New York state's CAA sections 111(d) and 129 revised
state plan for existing large municipal waste combustor units.

V. Incorporation by Reference

    In accordance with the requirements of 1 CFR 51.5, the EPA is
finalizing regulatory text that includes the incorporation by reference
of Table 2 of subdivision 200.10(b) at Part 200 of Title 6 NYCRR
(effective October 20, 2007) which is part of the CAA section 129 plan
applicable to existing large MWCs in New York. The regulatory provision
at 6 NYCRR section 200.10(b), entitled, ``Delegated Federal New Source
Performance Standards of 40 CFR 60,'' incorporates by reference the
Emission Guidelines (EG) for existing large MWCs, promulgated by the
EPA at 40 CFR part 60 subpart Cb, and establishes emission standards
and compliance times for the control of lead, mercury, cadmium,
organics, hydrogen chloride, and other air pollutants from certain MWCs
that commenced construction on or before September 20, 1994. The EPA
has made, and will continue to make, Table 2 of subdivision 200.10(b)
at Part 200 of Title 6 NYCRR generally available electronically through
www.regulations.gov, Docket No. EPA-R02-OAR-2018-0564 and in hard copy
at the EPA Region 2 office (please contact the person identified in the
For Further Information Contact section of this preamble for more
information). Therefore, these materials have been approved by EPA for
inclusion in the state plan, have been incorporated by reference by EPA
into that plan, and are fully federally enforceable under the CAA as of
the effective date of the final rulemaking.

VI. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a CAA
section 111(d)/129 plan submission that complies with the provisions of
the Act and applicable federal regulations. See 42 U.S.C. 7411(d); 40
CFR part 60 subparts B and Cb; and 40 CFR part 62 subpart A; and 40 CFR
62.04. Thus, in reviewing CAA section 111(d)/129 plan submissions, the
EPA's role is to approve state choices, provided that they meet the
criteria of the Act and implementing regulations. Accordingly, this
action, as finalized, merely approves state law that meets federal
requirements and does not impose additional requirements beyond those
imposed by state law. For that reason, this action, as finalized:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, Oct. 4, 1993) and Executive Order 13563 (76 FR
3821, Jan. 21, 2011);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, Aug. 10, 1999);
     Is not an ``economically significant'' regulatory action
based on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and

     Does not provide the EPA with the discretionary authority
to address, as appropriate, disproportionate human health or
environmental effects, using practicable and legally permissible
methods, under Executive Order 12898 (59 FR 7629, Feb. 16, 1994).
    In addition, this final rule is not approved to apply on any Indian
reservation land or in any other area where EPA or an Indian tribe has
demonstrated that a tribe has jurisdiction. In those areas of Indian
country, the rule does not have tribal implications and will not impose
substantial direct costs on tribal governments or preempt tribal law as
specified by Executive Order 13175 (65 FR 67249, Nov. 9, 2000).
    The Congressional Review Act, 5 U.S.C. 801 et seq., which was
included as part of the Small Business Regulatory Enforcement Fairness
Act of 1996, generally provides that before a rule may take effect, the
agency promulgating the rule must submit a rule report, which includes
a copy of the rule, to each House of Congress and to the Comptroller
General of the United States. The EPA will submit a report containing
this action and other required information to the U.S. Senate, the U.S.
House of Representatives, and the Comptroller General of the United
States prior to publication of the rule in the Federal Register. A
major rule cannot take effect until 60 days after it is published in
the Federal Register. This action is not a ``major rule'' as defined by
5 U.S.C. 804(2).
    Under section 307(b)(1) of the CAA, 42 U.S.C. 7607(b)(1), petitions
for judicial review of this action must be filed in the United States
Court of Appeals for the Second Circuit by November 2, 2021. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this action for the purposes of
judicial review, nor does it extend the time within which a petition
for judicial review may be filed, and shall not postpone the
effectiveness of such rule or action. This action may not be challenged
later in proceedings to enforce its requirements. (See section
307(b)(2), 42 U.S.C. 7607(b)(2).)

List of Subjects in 40 CFR Part 62

    Environmental protection, Administrative practice and procedure,
Air pollution control, Incorporation by reference, Intergovernmental
relations, Reporting and recordkeeping requirements, Sulfur oxides,
Waste treatment and disposal.

    Dated: August 26, 2021.
Walter Mugdan,
Acting Regional Administrator, Region 2.

    For the reasons stated in the preamble, the Environmental
Protection Agency amends 40 CFR part 62 as set forth below:

PART 62--APPROVAL AND PROMULGATION OF STATE PLANS FOR DESIGNATED
FACILITIES AND POLLUTANTS

0
1. The authority citation for part 62 continues to read as follows:

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

Subpart HH--New York

0
2. Amend Sec.  62.8103, by adding paragraphs (d) through (g) to read as
follows:

Sec.  62.8103  Identification of plan.

* * * * *
    (d) Identification of plan: On July 12, 2013, the New York State
Department of Environmental Conservation (NYSDEC) submitted to the
Environmental Protection Agency (EPA) a Clean Air Act section 111(d)/
129 revised plan, and the associated Table 2 of subdivision 200.10(b)
at Part 200 of Title 6 NYCRR, addressing 40 CFR part 60 subpart Cb,
``Emissions Guidelines and Compliance Times for Large Municipal Waste
Combustors That are Constructed on or Before September 20, 1994,'' as
amended on May 10, 2006. The plan includes the regulatory provisions
cited in paragraph (g) of this section, which the EPA incorporates by
reference.
    (e) Identification of sources: The plan applies to all existing
facilities in New York with a municipal waste combustion capacity
greater than 250 tons per day of municipal solid waste for which
construction commenced on or before September 20, 1994, and which are
subject to 40 CFR part 60 subpart Cb.
    (f) Effective date: The effective date of the plan for October 4,
2021.
    (g) Incorporation by reference:
    (1) The material incorporated by reference in this section was
approved by the Director of the Federal Register Office in accordance
with 5 U.S.C. 552(a)(1) and 1 CFR part 51. The material is available
from the sources identified elsewhere in this paragraph. It may be
inspected or obtained from the EPA Region 2 Office, 290 Broadway, 25th
Floor, New York, New York 10007-1866,<PHONE_NUMBER>. It may be inspected
at the National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, email
<EMAIL_ADDRESS>or go to: www.archives.gov/federal-register/cfr/ibr-locations.html.
    (2) State of New York, Department of State, Albany, New York 12231;
https://dos.ny.gov/state-register.
    (i) 6 NYCRR sec. 200.10(b)-Cb: Official Compilation of (New York)
Codes, Rules and Regulations; Title 6--Environmental Conservation; Part
200--General Provisions; Section 200.10--Federal standards and
requirements; Paragraph (b)--Table 2--Delegated Federal New Source
Performance Standards of 40 CFR 60, entry Cb, Large Municipal Waste
Combustors That are Constructed on or Before September 20, 1994;
effective September 4, 2019 (original effective date: October 20, 2007)
    (ii) [Reserved]

[FR Doc. 2021-19005 Filed 9-2-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 80, Number 168 (Monday, August 31, 2015)]
[Notices]
[Pages 52472-52473]
[FR Doc No: 2015-21485]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9933-28-OA]

Notification of a Public Teleconference of the Chartered Science
Advisory Board

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The EPA Science Advisory Board (SAB) Staff Office announces a
public teleconference of the Chartered SAB to discuss information
provided in the agency's Spring 2015 regulatory agenda and to review
the draft SAB report on the EPA's proposed Fourth Contaminant Candidate
List (CCL 4).

DATES: The public teleconference for the Chartered SAB will be held on
Thursday, September 24, 2015, from 11:00 a.m. to 1:30 p.m. (Eastern
Time).

ADDRESSES: The public teleconference will be conducted by telephone
only.

FOR FURTHER INFORMATION CONTACT: Any member of the public wishing to
obtain information concerning the public teleconference may contact Mr.
Thomas Carpenter, Designated Federal Officer (DFO), EPA Science
Advisory Board Staff Office (1400R), U.S. Environmental Protection
Agency, 1200 Pennsylvania Avenue NW., Washington, DC 20460; by
telephone/voice mail at<PHONE_NUMBER> or at<EMAIL_ADDRESS>
General information about the SAB as well as any updates concerning the
teleconference announced in this notice may be found on the EPA Web
site at http://www.epa.gov/sab.

SUPPLEMENTARY INFORMATION: The SAB was established pursuant to the
Environmental Research, Development, and Demonstration Authorization
Act (ERDDAA), codified at 42 U.S.C. 4365, to provide independent
scientific and technical advice to the Administrator on the technical
basis for Agency positions and regulations. The SAB is a federal
advisory committee chartered under the Federal Advisory Committee Act
(FACA), 5 U.S.C., App. 2. Pursuant to FACA and EPA policy, notice is
hereby given that the Chartered SAB will hold a public teleconference
for two purposes.
    (1) The first purpose is to discuss recommendations regarding the
information provided in the agency's Spring 2015 regulatory agenda,
specifically planned actions and their supporting science. Information
about this advisory activity can be found on the Web at http://yosemite.epa.gov/sab/sabproduct.nsf/fedrgstr_activites/SAB%20Spring%202015%20Reg%20Agenda?OpenDocument.
    (2) The second purpose of this public teleconference is to review a
draft SAB report on the EPA's proposed Fourth Contaminant Candidate
List (CCL 4). Quality review is a key function of the chartered SAB.
Draft reports prepared by SAB committees, panels, or work groups must
be reviewed and approved by the chartered SAB before transmittal to the
EPA Administrator. Consistent with FACA, the chartered SAB makes a
determination in a public meeting about each draft report and
determines whether the report is ready to be transmitted to the EPA
Administrator.
    The Safe Drinking Water Act (SDWA) requires EPA to consult with the

scientific community, including the Science Advisory Board, prior to
publishing a list of currently unregulated contaminants that are known
or anticipated to occur in public water systems and may require
regulation under the SDWA (referred to as the Contaminant Candidate
List, or CCL). This list is subsequently used to identify priority
contaminants for further research needs and to make determinations on
whether or not to regulate at least five contaminants from the CCL with
national primary drinking water regulations. The draft CCL4 includes
100 chemicals or chemical groups and 12 microbial contaminants.
Information about this advisory activity can be found on the Web at
http://yosemite.epa.gov/sab/sabproduct.nsf/fedrgstr_activites/CCL%204?OpenDocument.
    Availability of Meeting Materials: The agenda and materials in
support of this teleconference will be available on the EPA Web site at
http://www.epa.gov/sab in advance of the teleconference.
    Procedures for Providing Public Input: Public comment for
consideration by EPA's federal advisory committees and panels has a
different purpose from public comment provided to EPA program offices.
Therefore, the process for submitting comments to a federal advisory
committee is different from the process used to submit comments to an
EPA program office.
    Federal advisory committees and panels, including scientific
advisory committees, provide independent advice to EPA. Members of the
public can submit comments for a federal advisory committee to consider
as it develops advice for EPA. Input from the public to the SAB will
have the most impact if it provides specific scientific or technical
information or analysis for SAB panels to consider or if it relates to
the clarity or accuracy of the technical information. Members of the
public wishing to provide comment should contact the Designated Federal
Officer as noted above. Oral Statements: In general, individuals or
groups requesting an oral presentation at a teleconference will be
limited to three minutes. Each person making an oral statement should
consider providing written comments as well so that the points
presented orally can be expanded upon in writing. Interested parties
should contact Mr. Carpenter, DFO, in writing (preferably via email) at
the contact information noted above one week before the teleconference
to be placed on the list of public speakers. Written Statements:
Written statements should be supplied to the DFO, preferably via email,
at the contact information noted above one week before each of the
teleconferences so that the information may be made available to the
Board members for their consideration. It is the SAB Staff Office
general policy to post written comments on the Web page for the
advisory meeting or teleconference. Submitters are requested to provide
an unsigned version of each document because the SAB Staff Office does
not publish documents with signatures on its Web sites. Members of the
public should be aware that their personal contact information, if
included in any written comments, may be posted to the SAB Web site.
Copyrighted material will not be posted without explicit permission of
the copyright holder.
    Accessibility: For information on access or services for
individuals with disabilities, please contact Mr. Thomas Carpenter at
(202) 564-4885 or<EMAIL_ADDRESS>To request accommodation of
a disability, please contact Mr. Carpenter preferably at least ten days
prior to the teleconference to give EPA as much time as possible to
process your request.

    Dated: August 24, 2015.
Christopher S. Zarba,
Director, EPA Science Advisory Board Staff Office.
[FR Doc. 2015-21485 Filed 8-28-15; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 82, Number 140 (Monday, July 24, 2017)]
[Rules and Regulations]
[Pages 34261-34263]
[FR Doc No: 2017-15392]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2017-0385]
RIN 1625-AA00

Safety Zone; Canal Fest Water Ski Show; Erie Canal System, Fish
Creek, Sylvan Beach, NY

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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

SUMMARY: The Coast Guard is establishing a temporary safety zone on the
Erie Canal System, Fish Creek, Sylvan Beach, NY. This safety zone is
intended to restrict vessels from portions of the Erie Canal System at
Fish Creek during the Canal Fest Water Ski Show on August 13, 2017.
This temporary safety zone is necessary to protect mariners and vessels
from the navigational hazards associated with high speed craft and
water skiers. Entry of vessels or persons into this zone is prohibited
unless specifically authorized by the Captain of the Port Buffalo.

DATES: This rule is effective from 12:15 p.m. to 2:45 p.m. August 13,
2017.

ADDRESSES: To view documents mentioned in this preamble as being

available in the docket, go to http://www.regulations.gov, type USCG-
2017-0385 in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
rulemaking, call or email LT Michael Collet, Chief of Waterways
Management, U.S. Coast Guard Sector Buffalo; telephone<PHONE_NUMBER>,
email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background Information and Regulatory History

    On April 9, 2017, the Sylvan Verona Beach Resort Association
notified the Coast Guard that from 12:30 p.m. to 2:30 p.m. on August
13, 2017, it will be conducting a water ski show in the Erie Canal
System at Fish Creek in Sylvan Beach, NY. In response, on June 9, 2017,
the Coast Guard published a notice of proposed rulemaking (NPRM) titled
Safety Zone; Canal Fest Water Ski Show; Erie Canal System, Fish Creek,
Sylvan Beach, NY. There we stated why we issued the NPRM, and invited
comments on our proposed regulatory action related to this water ski
show. During the comment period that ended July 10, 2017, we received 0
comments.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this temporary rule effective less than 30 days after
publication in the Federal Register because doing so would be
impracticable and contrary to the public interest. Delaying the
effective date would be contrary to the rule's objectives of ensuring
safety of life on the navigable waters and protection of persons and
vessels near the water ski show.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 33 U.S.C.
1231. The Captain of the Port Buffalo (COTP) has determined that a
water ski show presents significant risks to public safety and
property. Such hazards include high speed craft and multiple water
skiers performing in a relatively small area. This rule is needed to
protect personnel, vessels, and the marine environment in the navigable
waters within the safety zone while the water ski show is taking place.

IV. Discussion of the Rule

    This rule establishes a safety zone on August 13, 2017 12:15 p.m.
to 2:45 p.m. The safety zone will encompass all waters of the Erie
Canal System, Fish Creek, Sylvan Beach, NY contained within the
following points: 43[deg]11'37.79'' N., 075[deg]43'53.27'' W., running
Northeast to position 43[deg]11'43.15'' N., 075[deg]43'44.88'' W., then
Southeast to 43[deg]11'42.82'' N., 075[deg]43'43.42'' W. then Southwest
to 43[deg]11'36.90'' N., 075[deg]43'52.06'' W. then returning to the
point of origin (NAD83).
    Entry into, transiting, or anchoring within the safety zone is
prohibited unless authorized by the Captain of the Port Buffalo or his
designated on-scene representative. The Captain of the Port or his
designated on-scene representative may be contacted via VHF Channel 16.

V. Regulatory Analyses

    We developed this rule after considering numerous statutes and
Executive Orders related to rulemaking. Below we summarize our analyses
based on a number of these statutes and Executive Orders, and we
discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive Order 13563 emphasizes the importance of
quantifying both costs and benefits, of reducing costs, of harmonizing
rules, and of promoting flexibility. Executive Order 13771 (``Reducing
Regulation and Controlling Regulatory Costs''), directs agencies to
reduce regulation and control regulatory costs and provides that ``for
every one new regulation issued, at least two prior regulations be
identified for elimination, and that the cost of planned regulations be
prudently managed and controlled through a budgeting process.''
    This rule has not been designated a ``significant regulatory
action,'' under Executive Order 12866. Accordingly, it has not been
reviewed by the Office of Management and Budget.
    As this rule is not a significant regulatory action, this rule is
exempt from the requirements of Executive Order 13771. See OMB's
Memorandum titled ``Interim Guidance Implementing Section 2 of the
Executive Order of January 30, 2017 titled `Reducing Regulation and
Controlling Regulatory Costs' '' (February 2, 2017).
    We conclude that this rule is not a significant regulatory action
because we anticipate that it will have minimal impact on the economy,
will not interfere with other agencies, will not adversely alter the
budget of any grant or loan recipients, and will not raise any novel
legal or policy issues. The safety zone created by this rule will be
relatively small and enforced for a short duration of time. Also, the
safety zone is designed to minimize its impact on navigable waters.
Thus, restrictions on vessel movement within the particular areas are
expected to be minimal. Under certain conditions, moreover, vessels may
still transit through the safety zone when permitted by the Captain of
the Port.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
will not have a significant economic impact on a substantial number of
small entities.
    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
V.A above, this rule will not have a significant economic impact on any
vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain

about this rule or any policy or action of the Coast Guard.

C. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this rule under that Order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes. If
you believe this rule has implications for federalism or Indian tribes,
please contact the person listed in the FOR FURTHER INFORMATION CONTACT
section above.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such expenditure, we do discuss the effects of this rule elsewhere in
this preamble.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that it
is one of a category of actions that do not individually or
cumulatively have a significant effect on the human environment. This
rule establishes a temporary safety zone. It is categorically excluded
under section 2.B.2, figure 2-1, paragraph 34(g) of the Instruction,
which pertains to establishment of safety zones. A Record of
Environmental Consideration (REC) supporting this determination is
available in the docket where indicated in the ADDRESSES section of
this preamble.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority:  33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-
1, 6.04-6, and 160.5; Department of Homeland Security Delegation No.
0170.1.

0
2. Add Sec.  165.T09-0385 to read as follows:

Sec.  165.T09-0385  Safety Zone; Canal Fest Water Ski Show, Erie Canal
System, Fish Creek, Sylvan Beach, NY.

    (a) Location. The safety zone will encompass all waters of the Erie
Canal System, Fish Creek starting at position 43[deg]11'37.79'' N.,
075[deg]43'53.27'' W., running Northeast to position 43[deg]11'43.15''
N., 075[deg]43'44.88'' W., then Southeast to 43[deg]11'42.82'' N.,
075[deg]43'43.42'' W. then Southwest to 43[deg]11'36.90'' N.,
075[deg]43'52.06'' W. then returning to the point of origin. (NAD 83).
    (b) Enforcement period. This regulation will be enforced on August
13, 2017 from 12:15 p.m. until 2:45 p.m.
    (c) Regulations. (1) In accordance with the general regulations in
Sec.  165.23 of this part, entry into, transiting, or anchoring within
this safety zone is prohibited unless authorized by the Captain of the
Port Buffalo or his designated on-scene representative.
    (2) This safety zone is closed to all vessel traffic, except as may
be permitted by the Captain of the Port Buffalo or his designated on-
scene representative.
    (3) The ``on-scene representative'' of the Captain of the Port
Buffalo is any Coast Guard commissioned, warrant or petty officer who
has been designated by the Captain of the Port Buffalo to act on his
behalf.
    (4) Vessel operators desiring to enter or operate within the safety
zone must contact the Captain of the Port Buffalo or his on-scene
representative to obtain permission to do so. The Captain of the Port
Buffalo or his on-scene representative may be contacted via VHF Channel
16. Vessel operators given permission to enter or operate in the safety
zone must comply with all directions given to them by the Captain of
the Port Buffalo, or his on-scene representative.

    Dated: July 18, 2017.
Joseph S. Dufresne,
Captain, U.S. Coast Guard, Captain of the Port Buffalo.
[FR Doc. 2017-15392 Filed 7-21-17; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 76, Number 124 (Tuesday, June 28, 2011)]
[Notices]
[Page 37805]
[FR Doc No: 2011-16173]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER11-3312-000]

New York Independent System, Operator, Inc.; Notice of Filing

    Take notice that, on June 21, 2011, the New York Independent System
Operator, Inc. filed to amend its filing in the above captioned docket
with information required under the Commission's regulations. Such
filing served to reset the filing date in this proceeding.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date.
Anyone filing a motion to intervene or protest must serve a copy of
that document on the Applicant and all the parties in this proceeding.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on July 12, 2011.

    Dated: June 22, 2011.
Kimberly D. Bose,
Secretary.
[FR Doc. 2011-16173 Filed 6-27-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 228 (Wednesday, November 29, 2017)]
[Notices]
[Page 56598]
[FR Doc No: 2017-25755]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following electric
corporate filings:

    Docket Numbers: EC13-91-001.
    Applicants: Florida Power & Light Company.
    Description: Notice of Non-Material Change in Circumstances of
Florida Power & Light Company.
    Filed Date: 11/21/17.
    Accession Number: 20171121-5173.
    Comments Due: 5 p.m. ET 12/12/17.

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER15-2594-006; ER17-953-002.
    Applicants: South Central MCN LLC.
    Description: Compliance Filing of South Central MCN, LLC.
    Filed Date: 11/20/17.
    Accession Number: 20171120-5186.
    Comments Due: 5 p.m. ET 12/11/17.

    Docket Numbers: ER17-568-001.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Compliance filing: 2017-11-22_Attachment X Compliance
for Quarterly Operating Limits to be effective 2/15/2017.
    Filed Date: 11/22/17.
    Accession Number: 20171122-5032.
    Comments Due: 5 p.m. ET 12/13/17.

    Docket Numbers: ER17-723-001.
    Applicants: NRG Power Marketing LLC.
    Description: Report Filing: Refund Report--Informational Filing
(Docket No. EL17-49-000) to be effective N/A.
    Filed Date: 11/22/17.
    Accession Number: 20171122-5056.
    Comments Due: 5 p.m. ET 12/13/17.

    Docket Numbers: ER18-326-000.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Sec.  205(d) Rate Filing: 2017-11-22_SA 3061
MidAmerican-MidAmerican GIA (J475 J555) to be effective 11/7/2017.
    Filed Date: 11/22/17.
    Accession Number: 20171122-5002.
    Comments Due: 5 p.m. ET 12/13/17.

    Docket Numbers: ER18-327-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Original Service Agreement
No. 4847, Queue Position No. AB2-084 to be effective 10/25/2017.
    Filed Date: 11/22/17.
    Accession Number: 20171122-5064.
    Comments Due: 5 p.m. ET 12/13/17.

    Take notice that the Commission received the following PURPA
210(m)(3) filings:

    Docket Numbers: QM18-3-000.
    Applicants: Nebraska Public Power District, Nebraska Electric
Generation and Transmission Cooperative, Inc.
    Description: Joint Request of Nebraska Public Power District, et
al. for Partial Waiver of PURPA Obligations of Electric Utilities.
    Filed Date: 11/20/17.
    Accession Number: 20171120-5184.
    Comments Due: 5 p.m. ET 12/18/17.

    Docket Numbers: QM18-4-000.
    Applicants: Nebraska Public Power District, Nebraska Electric
Generation and Transmission Cooperative, Inc.
    Description: Joint Request of Nebraska Public Power District, et
al. to Terminate Mandatory Purchase Obligation under PURPA.
    Filed Date: 11/20/17.
    Accession Number: 20171120-5185.
    Comments Due: 5 p.m. ET 12/18/17.

    Take notice that the Commission received the following electric
reliability filings:

    Docket Numbers: RR18-1-000.
    Applicants: North American Electric Reliability Corporation.
    Description: Petition of the North American Electric Reliability
Corporation for Approval of Proposed Revisions to Appendix 3D to the
Rules of Procedure.
    Filed Date: 11/21/17.
    Accession Number: 20171121-5170.
    Comments Due: 5 p.m. ET 12/12/17.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: November 22, 2017.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2017-25755 Filed 11-28-17; 8:45 am]
 BILLING CODE 6717-01-P


"Schwab, Margo"<EMAIL_ADDRESS> 03/10/2008 12:40 PM

To

Neal Fann/RTP/USEPA/US@EPA

cc

Bryan Hubbell/RTP/USEPA/US@EPA, "King, Heidi R." <EMAIL_ADDRESS>Lydia Wegman/RTP/USEPA/US@EPA, Ron Evans/RTP/USEPA/US@EPA, Tricia Crabtree/RTP/USEPA/US@EPA, Nathalie Simon/DC/USEPA/US@EPA

Subject

RE: Ron, can you share this with Bryan Hubbell also

Edits for clarity attached.

-----Original Message-----

From<EMAIL_ADDRESS><EMAIL_ADDRESS> Sent: Monday, March 10, 2008 12:19 PM

To: Schwab, Margo

Cc<EMAIL_ADDRESS>King, Heidi R.;

<EMAIL_ADDRESS><EMAIL_ADDRESS> <EMAIL_ADDRESS><EMAIL_ADDRESS> Subject: RE: Ron, can you share this with Bryan Hubbell also

Margo,

Attached is the revised version of section 7.5.1, as we discussed.

Thanks,

Neal

(See attached file: Ozone RIA Section 7.5.1.doc)

_________________________________

Neal Fann

USEPA

Office of Air Quality Planning & Standards Air Benefit and Cost Group

C439-02

RTP, NC 27711

voice:<PHONE_NUMBER>

fax:<PHONE_NUMBER>

             "Schwab, Margo"

             <Margo_Schwab@om

             b.eop.gov>                                              To

                                      Ron Evans/RTP/USEPA/US@EPA

             03/10/2008 10:59                                        cc

             AM                       Bryan Hubbell/RTP/USEPA/US@EPA,

                                      "King, Heidi R."

<EMAIL_ADDRESS>

                                      Lydia Wegman/RTP/USEPA/US@EPA,

                                      Neal Fann/RTP/USEPA/US@EPA,

                                      Tricia Crabtree/RTP/USEPA/US@EPA

                                                                Subject

                                      RE: Ron, can you share this with

                                      Bryan Hubbell also

Ok. I'm at<PHONE_NUMBER>

-----Original Message-----

From<EMAIL_ADDRESS><EMAIL_ADDRESS> Sent: Monday, March 10, 2008 10:57 AM

To: Schwab, Margo

Cc<EMAIL_ADDRESS>King, Heidi R.;

<EMAIL_ADDRESS><EMAIL_ADDRESS> <EMAIL_ADDRESS> Subject: RE: Ron, can you share this with Bryan Hubbell also

We will try to arrange something in the next 10 minutes.

Ron Evans

Leader, Air Benefit & Cost Group

HEID/OAQPS/OAR/EPA

Mail Drop C-439-02

919-541-5488

919-541-0839 fax

We do one thing: overwhelm people's impossible expectations.

             "Schwab, Margo"

             <Margo_Schwab@om

             b.eop.gov>                                              To

                                      Ron Evans/RTP/USEPA/US@EPA,

             03/10/2008 10:43         "King, Heidi R."

             AM<EMAIL_ADDRESS>                                                                      cc

                                      Neal Fann/RTP/USEPA/US@EPA, Bryan

                                      Hubbell/RTP/USEPA/US@EPA, Lydia

                                      Wegman/RTP/USEPA/US@EPA

                                                                Subject

                                      RE: Ron, can you share this with

                                      Bryan Hubbell also

 Ron: Heidi is busy, but could talk briefly with you and Neal about some

technical questions?  I'm open all morning.  Margo

-----Original Message-----

From<EMAIL_ADDRESS><EMAIL_ADDRESS> Sent: Monday, March 10, 2008 10:02 AM

To: King, Heidi R.

Cc: Schwab, Margo<EMAIL_ADDRESS>Johansson, Robert;

<EMAIL_ADDRESS><EMAIL_ADDRESS> <EMAIL_ADDRESS><EMAIL_ADDRESS> <EMAIL_ADDRESS><EMAIL_ADDRESS> Subject: Re: Ron, can you share this with Bryan Hubbell also

Heidi, we have reviewed Margo's suggested changes to discussion on 8 vs

24 hour metrics.  The blue shows our minor edits, otherwise we are

comfortable with making the changes as requested.  Let me know if you

have any questions.

Both the NMMAPS analysis and the individual time series studies upon

which the meta analyses were based use the 24-hour average or 1-hour

maximum ozone levels as exposure metrics.  The 24-hour average is not

the most relevant ozone exposure metric to characterize population-level

exposure. Given that the majority of the people tend to be outdoors

during the daylight hours and concentrations are highest during the

daylight hours, the 24-hour average metric is not appropriate.

Moreover, the 1-hour maximum metric uses an exposure window different

than that that used for the current ozone NAAQS.  Together, this means

that the most biologically relevant metric, and the one used in the

ozone NAAQS since 1997 is the 8-hour maximum standard.  Thus, although

our analysis at proposal calculated impact functions based on either the

24 hour average or 1-hour maximum ozone levels originally reported in

the epidemiogical studies, for the final rule analysis, we have

converted ozone mortality health impact functions that use a 24-hour

average or 1-hour maximum ozone metric to maximum 8-hour average ozone

concentration using standard conversion functions.

   This practice is consistent both with the available exposure modeling

   and with the form of the current ozone standard. This conversion also

   does not affect the relative magnitude of the health impact function.

   An equivalent change in the 24-hour average, 1-hour maximum and

   8-hour maximum will provide the same overall change in incidence of a

   health effect. The conversion ratios are based on observed

   relationships between the 24-hour average and 8-hour maximum ozone

   values. For example, in the Bell et al., 2004 analysis of

   ozone-related premature mortality, the authors found that the

   relationship between the 24-hour average, the 8-hour maximum, and the

   1-hour maximum was 2:1.5:1, so that the derived health impact effect

   estimate based on the 1-hour maximum should be half that of the

   effect estimate based on the 24-hour values (and the 8-hour maximum

   three-quarters of the 24-hour effect estimate).

   Ron Evans

   Leader, Air Benefit & Cost Group

   HEID/OAQPS/OAR/EPA

   Mail Drop C-439-02

<PHONE_NUMBER>

<PHONE_NUMBER> fax

   We do one thing: overwhelm people's impossible expectations.

             "King, Heidi R."

             <Heidi_R._King@o

             mb.eop.gov>                                             To

                                      Ron Evans/RTP/USEPA/US@EPA, Neal

             03/07/2008 01:59         Fann/RTP/USEPA/US@EPA

             PM                                                      cc

                                      "Schwab, Margo"

<EMAIL_ADDRESS>                                       "Johansson, Robert"

<EMAIL_ADDRESS>                                                                 Subject

                                      Ron, can you share this with

                                      Bryan Hubbell also

Ron, a note from Margo, can you pls fwd to Bryan?

Bryan - per our discussion yesterday, below is language to replace the

entire 'OZONE EXPOSURE METRIC' subsection of the mortality section

(PAGES 7-13 TO 7-14).  The first paragraph is a slightly edited version

of something that I sent over during L and M.  The second paragraph is

the only piece that I suggest you keep from the original write up (the

original write up is copied below).

Both the NMMAPS analysis and the individual time series studies upon

which the meta analyses were based use the 24-hour average ozone level

as an exposure metric.  The 24-hour average is not the most relevant

ozone exposure metric to characterize population-level exposure given

that the majority of the people tend to be outdoors during the daylight

hours.  Furthermore, concentrations are highest during the daylight

hours.  Together, this means that the most biologically relevant metric,

and the one used in the ozone NAAQS since 1997 is the 8-hour maximum

standard.  Thus, although our analysis at proposal calculated impact

functions based on the 24 hour average ozone levels originally reported

in the epidemiogical studies,  for the final rule analysis, we have

converted health impact functions that use a 24-hour average ozone

metric to maximum 8-hour average ozone concentration using standard

conversion functions.

This practice is consistent both with the available exposure modeling

and with the form

of the current ozone standard. This conversion also does not affect the

relative magnitude of the

health impact function. An equivalent change in the 24-hour average and

8-hour maximum will

provide the same overall change in incidence of a health effect. The

conversion ratios are based

on observed relationships between the 24-hour average and 8-hour maximum

ozone values. For

example, in the Bell et al., 2004 analysis of ozone-related premature

mortality, the authors found

that the relationship between the 24-hour average, the 8-hour maximum,

and the 1-hour

maximum was 2:1.5:1, so that the derived health impact effect estimate

based on the 1-hour

maximum should be half that of the effect estimate based on the 24-hour

values (and the 8-hour

maximum three-quarters of the 24-hour effect estimate).

For your reference, here is LANGUAGE THAT IS CURRENTLY ON PAGES 7-13,

14, 15 (and thus being replaced)

Ozone Exposure Metric

Because several of the ozone mortality epidemiology studies report their

base results relating

mortality to 24-hour average ozone, the importance of understanding the

biological relevance of

the 24-hour metric relative to other possible metrics is critical. Our

air quality modeling projects

ozone-related disbenefits to occur in small regions within specific

urban cores such as Chicago

and Detroit. When NOx reductions increase ozone in these regions,

however, it is typically

during nighttime and early morning hours, when NOx titrates ozone.

Because human exposure

to ozone is a function of the temporal and spatial patterns of ambient

concentrations of ozone in

the atmosphere, the ozone-related health impacts analysis is especially

sensitive to which ozone

exposure metric we use in the health impact functions.19

7-14

Prior to the addition of ozone-related premature mortality functions to

the health impacts

analysis, most of our ozone health impact functions have used metrics

which are less sensitive to

ozone disbenefits (e.g., 8-hour daily average). For example, emergency

department visits for

asthma are related to 1- or 8-hour maxima. School absences are based on

8-hour mean and 1-

hour maximum ozone levels. It should be noted that ozone disbenefits

that occur during daylight

hours, when ozone is higher, are accounted for in these averages.

Epidemiology studies are retrospective in nature and focus on

identifying a statistical

relationship between some measure of ozone and a health outcome. The

specific

epidemiological studies that form the basis for the ozone mortality

impact estimates use timeseries

statistical methods that estimate the relationship between daily ozone

levels and mortality

based on day to day variations in ozone and mortality. The focus of

these studies is not as much

on a specific ozone averaging time as on the day to day variation in the

ozone metrics. In fact,

epidemiologists often analyze and report results for multiple ozone

metrics, but may report

results for only one metric in the abstract of an article.

In most cases, the day to day variation in different metrics (24-hour

average vs 8-hour maximum,

for example) is highly correlated. As such, the relationships between

mortality and different

ozone metrics will be highly correlated as well. However, when we apply

the mortality impact

functions derived from these time-series results to evaluate the impacts

of a specific control

measure, we do not focus on the day to day variation in ozone levels so

much as the shift in the

overall distribution of ozone concentrations over an entire season.

Because specific emission

control strategies might result in a different diurnal profile than was

observed in the monitored

ozone data used in the studies, it is important to choose an ozone

metric that is best suited to

capturing changes in ozone that are likely to occur during hours where

populations are likely to

be exposed to the ozone.

To address this issue in the final rule analysis, we have followed a

process outlined in the

Locomotive and Marine Diesel RIA (EPA, 2008) and used standard

conversion functions to

convert ozone-related premature mortality health impact functions that

use a 24-hour average or

1-hour maximum ozone metric to functions that use an 8-hour maximum

ozone concentration

instead. This practice is consistent both with the available exposure

modeling and with the form

of the current ozone standard. This conversion also does not affect the

relative magnitude of the

health impact function. An equivalent change in the 24-hour average and

8-hour maximum will

provide the same overall change in incidence of a health effect. The

conversion ratios are based

on observed relationships between the 24-hour average and 8-hour maximum

ozone values. For

example, in the Bell et al., 2004 analysis of ozone-related premature

mortality, the authors found

that the relationship between the 24-hour average, the 8-hour maximum,

and the 1-hour

maximum was 2:1.5:1, so that the derived health impact effect estimate

based on the 1-hour

maximum should be half that of the effect estimate based on the 24-hour

values (and the 8-hour

maximum three-quarters of the 24-hour effect estimate).

The conversion of ozone metrics does not require adjustment to the air

quality modeling. It

preserves the observed patterns of ozone-related disbenefits, and allows

for disbenefits to occur

in the health impact estimates if those disbenefits occur during hours

when populations are likely

7-15

to be exposed. In future analyses, we will also convert the ozone

exposure metrics in morbidity

studies that do not use an 8-hour exposure metric.


[Federal Register Volume 84, Number 117 (Tuesday, June 18, 2019)]
[Notices]
[Pages 28379-28381]
[FR Doc No: 2019-12788]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-86095; File No. SR-NASDAQ-2019-049]

Self-Regulatory Organizations; The Nasdaq Stock Market LLC;
Notice of Filing of Proposed Rule Change To Amend the Definition of
Family Member in Listing Rule 5605(a)(2) for Purposes of the Definition
of Independent Director

June 12, 2019.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on May 29, 2019, The Nasdaq Stock Market LLC (``Nasdaq'' or
``Exchange'') filed with the Securities and Exchange Commission
(``SEC'' or ``Commission'') the proposed rule change as described in
Items I, II, and III, below, which Items have been prepared by the
Exchange. The Commission is publishing this notice to solicit comments
on the proposed rule change from interested persons.
---------------------------------------------------------------------------

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

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

    The Exchange proposes to modify the definition of a ``Family
Member'' for purposes of Listing Rule 5605(a)(2).
    The text of the proposed rule change is set forth below. Proposed
new language is italicized.

The Nasdaq Stock Market Rules

* * * * *
5605. Board of Directors and Committees
(a) Definitions
    (1) No change.
    (2) ``Independent Director'' means a person other than an Executive
Officer or employee of the Company or any other individual having a
relationship which, in the opinion of the Company's board of directors,
would interfere with the exercise of independent judgment in carrying
out the responsibilities of a director. For purposes of this rule,
``Family Member'' means a person's spouse, parents, children,[ and]
siblings, [whether by blood, marriage or adoption, or anyone residing
in ] mothers and fathers-in-law, sons and daughters-in-law, brothers
and sisters-in-law, and anyone (other than domestic employees) who
shares such person's home. The following persons shall not be
considered independent:
    (A)-(G) No change.
* * * * *
    The text of the proposed rule change is available on the Exchange's
website at http://nasdaq.cchwallstreet.com, at the principal office of
the Exchange, and at the Commission's Public Reference Room.

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

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

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

1. Purpose
    Nasdaq is proposing to modify the definition of a ``Family Member''
for purposes of director independence under Listing Rule 5605(a)(2) to
exclude stepchildren by reverting to the language of the rule before it
was paraphrased. Currently, the rule provides that ``children . . . by
marriage,'' or stepchildren, are considered Family Members. Nasdaq
believes this category was added to the definition of a Family Member
inadvertently and that such an expansion of the definition is
unwarranted.
    Rule 5605(a) provides a list of certain relationships that preclude
a board from finding that a director is independent. These objective
measures provide transparency to investors and companies, facilitate
uniform application of the rules, and ease administration. Nasdaq's
rules preclude a director from being considered independent if the
director has a Family Member who (i) accepted any compensation from the
Company in excess of $120,000 during any period of twelve consecutive
months within the three years preceding the determination of
independence (with certain exceptions); \3\ (ii) is, a partner in, or a
controlling Shareholder or an Executive Officer of, any organization to
which the Company made, or from which the Company received, payments
for property or services in the current or any of the past three fiscal
years that exceed 5% of the recipient's consolidated gross revenues for
that year, or $200,000, whichever is more (with certain exceptions);
\4\ (iii) is, employed as an Executive Officer of another entity where
at any time during the past three years any of the Executive Officers
of the Company served on the compensation committee of such other
entity; \5\ or (iv) is, a current partner of the Company's outside
auditor, or was a partner or employee of the Company's outside auditor
who worked on the Company's audit at any time during any of the past
three years.\6\ Nasdaq's rules also preclude a director from being
considered independent if such director is a Family Member of an
individual who is, or at any time during the past three years was,
employed by the Company as an Executive Officer.\7\
---------------------------------------------------------------------------

    \3\ Listing Rule 5605(a)(2)(B).
    \4\ Listing Rule 5605(a)(2)(D).
    \5\ Listing Rule 5605(a)(2)(E).
    \6\ Listing Rule 5605(a)(2)(F).
    \7\ Listing Rule 5605(a)(2)(C).
---------------------------------------------------------------------------

    Currently, for purposes of Nasdaq Rules, Family Member means a
person's spouse, parents, children and siblings, whether by blood,
marriage or adoption, or anyone residing in such person's home.\8\ This
definition includes stepchildren, as they are ``children by . . .
marriage.''
---------------------------------------------------------------------------

    \8\ Listing Rule 5605(a)(2).
---------------------------------------------------------------------------

    When Nasdaq first adopted this rule in 1999, Family Member was
defined as a person's spouse, parents, children, siblings, mother-in-
law, father-in-law, brother-in-law, sister-in-law, and anyone who
resides in such person's home.\9\ The rule was subsequently amended to
include sons-in-law and daughters-in-law in the definition of a Family
Member.\10\ At that point, the New York Stock Exchange's (``NYSE'')
definition of an ``immediate family

member,'' which is still in effect, and Nasdaq's definition of the
Family Member became nearly identical.\11\
---------------------------------------------------------------------------

    \9\ See Securities Exchange Act Release No. 41982 (October 6,
1999), 64 FR 55510 (October 13, 1999).
    \10\ See Securities Exchange Act Release No. 42231 (December 14,
1999), 64 FR 71523 (December 21, 1999).
    \11\ Section 303A.02 of the NYSE Listed Company Manual states
that ``An ``immediate family member'' includes a person's spouse,
parents, children, siblings, mothers and fathers-in-law, sons and
daughters-in-law, brothers and sisters-in-law, and anyone (other
than domestic employees) who shares such person's home.''
---------------------------------------------------------------------------

    In 2002, Nasdaq undertook a comprehensive review of its corporate
governance rules and adopted a package of corporate governance
reforms.\12\ At about the same time, NYSE implemented similar changes
to its listing standards.\13\ The Commission discussed and approved
both the Nasdaq Independent Director Proposal and the NYSE Corporate
Governance Proposal in one order (the ``Order'').\14\
---------------------------------------------------------------------------

    \12\ On October 9, 2002, the NASD, through its subsidiary, The
Nasdaq Stock Market, Inc., filed with the Commission a proposed rule
change to amend NASD Rules to modify requirements relating to board
independence and independent committees. See Securities Exchange Act
Release No. 47516 (March 17, 2003), 68 FR 14451 (March 25, 2003)
(SR-NASD-2002-141) (``Nasdaq Independent Director Proposal'').
    \13\ See Securities Exchange Act Release No. 47672 (April 11,
2003) 68 FR 19051 (April 17, 2003) (``NYSE Corporate Governance
Proposal'').
    \14\ See Securities Exchange Act Release No. 48745 (November 4,
2003), 68 FR 64154 (November 12, 2003).
---------------------------------------------------------------------------

    As part of the Nasdaq Independent Director Proposal, Nasdaq changed
the definition of Family Member to mean ``a person's spouse, parents,
children and siblings, whether by blood, marriage or adoption, or
anyone residing in such person's home.'' This change was meant to
simplify the existing definition of a Family Member, while not
introducing any substantive changes and Nasdaq did not discuss any
potential substantive change to the definition in its rule filing.
Similarly, NYSE retained unchanged the definition of the immediate
family member in the NYSE Corporate Governance Proposal. In the Order,
the Commission reviewed and analyzed both Nasdaq's new definition of
the Family Member and the NYSE's existing definition and did not note
any potential differences.\15\
---------------------------------------------------------------------------

    \15\ Id.
---------------------------------------------------------------------------

    Over time, Nasdaq has heard from its listed companies and their
legal counsel that the change to the definition of a Family Member did
not simplify the application of the rule. Instead, while preparing
director and officer questionnaires the companies' legal counsel often
need to analyze potential differences in the meaning of Nasdaq's
definition of a Family Member and NYSE's definition of an immediate
family member. In particular, this burdensome analysis occurs when a
company transfers its listing from one national securities exchange to
another. In such case, a director may have already filled out an annual
questionnaire based on the exchange's definition of a family member,
but may need to answer additional questions because the definition of
the exchange the listing is transferred to is phrased differently.
    In particular, Nasdaq has discovered that the revised definition of
a Family Member was broader than the prior version and now
inadvertently includes stepchildren of a director because such
individuals are ``children . . . by marriage'' even though they are not
``sons-in-law'' or ``daughters-in-law'' or any other category from the
old definition. In one situation that Nasdaq observed the director
married a person who had an adult child. Because the director never
acted in any capacity as a parent of this stepchild, and the stepchild
never shared the director's household, the director and stepchild had
an attenuated relationship. Accordingly, Nasdaq believes that such a
relationship should not preclude a director from being considered
independent in all circumstances.
    Nasdaq believes that the analysis of the potential differences in
the definition of family members is an unnecessary and unintentional
burden on listed companies because Nasdaq's current definition of a
Family Member was meant to paraphrase the then-existing definition of a
Family Member, while not introducing any substantive changes. In
addition, as described above, the Commission reviewed and analyzed both
Nasdaq's new definition of a Family Member and the NYSE's existing
definition of an immediate family member, which is nearly identical to
the Nasdaq's old definition of a Family Member, and did not note any
potential differences. Accordingly, Nasdaq is proposing to modify the
definition of a Family Member for purposes of director independence
under Listing Rule 5605(a)(2) to revert to the language of the rule
before it was paraphrased.
    Nasdaq is also proposing to modify the definition of a ``Family
Member'' for purposes of director independence under Listing Rule
5605(a)(2) to exclude domestic employees who share a director's home.
Nasdaq believes that the definition of a Family Member should not
include a domestic employee who shares a director's home because this
definition is intended to capture familial, not commercial,
relationships.
    Notwithstanding these changes, Nasdaq notes that a company's board
must, under the Rule and IM-5605, affirmatively determine that no
relationship exists that would interfere with the exercise of
independent judgment in carrying out the director's responsibilities.
Nasdaq believes that it is appropriate for the board to review a
potential relationship between a director and a domestic employee or a
child of the director's spouse under such facts and circumstances test.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\16\ in general, and furthers the objectives of Section
6(b)(5) of the Act,\17\ in particular, in that it is designed to
promote just and equitable principles of trade, to remove impediments
to and perfect the mechanism of a free and open market and a national
market system, and, in general to protect investors and the public
interest, by removing the impediments to a free in [sic] open market
where a ``bright line'' independence test prohibits some directors from
being deemed independent in circumstances where the relationship with a
Family Member is attenuated, non-existent, or commercial in nature.
Nasdaq also believes that the proposed rule change is designed to
remove impediments to and perfect the mechanism of a free and open
market by aligning Nasdaq's and NYSE's corporate governance
requirements more closely, by contrast to current differently phrased
definitions of a Family Member on Nasdaq and an immediate family member
on NYSE and inclusion of a domestic employee who shares the director's
home in Nasdaq's definition of a Family Member, where such differences
pose an unnecessary burden on listed companies.
---------------------------------------------------------------------------

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

    Specifically, Nasdaq listing rules currently prohibit a director
from being deemed independent in certain circumstances by including
stepchildren of the directors' spouse [sic] in the definition of a
Family Member, as described in more detail above. The rule also
prohibits a domestic employee who shares the director's home from being
deemed independent by including such employee in the definition of a
Family Member.
    Independent directors over time became a linchpin in the American
corporate governance. It is important for investors to have confidence
that individuals serving as independent directors do not have a
relationship with the listed company that would impair their
independence. As the

importance of independent directors for listed companies increased, so
did the directors' workload and the risk of litigation. In this
environment, Nasdaq believes that it is appropriate not to prohibit
directors from being considered independent based on certain commercial
or attenuated familial relationships, but instead allow the board to
review such a relationship and affirmatively determine a relationship
exists that would interfere with the exercise of independent judgment
in carrying out the director's responsibilities.
    Additionally, as proposed, Listing Rule 5605(a)(2) would remain
consistent with the SEC Rule 10A-3 promulgated under the Act.\18\ In
particular, Rule 10A-3(e)(8) provides that a director is no longer
considered independent for audit committee service upon, among other
things, indirect acceptance of compensatory payments to ``spouses,
minor children or stepchildren or children or stepchildren sharing a
home with the member.'' Thus, the SEC's audit committee independence
rule focuses only on payments to ``minor children or stepchildren'' or
``stepchildren sharing a home with the member'' and would not capture
the activities of a stepchild of a director, particularly one who does
not nor has ever shared a household. Similarly, Rule 10A-3 does not
capture the activities of directors' domestic employees.
---------------------------------------------------------------------------

    \18\ 17 CFR 240.10A-3.
---------------------------------------------------------------------------

    Following the proposed rule change, Nasdaq's definition of the
Family Member will be became identical with the NYSE's definition of an
``immediate family member,'' the definition that the Commission has
previously approved.\19\
---------------------------------------------------------------------------

    \19\ See footnote 14, above.
---------------------------------------------------------------------------

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 not necessary or appropriate in
furtherance of the purposes of the Act. The proposed rule change would
eliminate requirements that burden issuers without an offsetting
benefit in protecting shareholders. All listed companies would be
affected in the same manner by these changes. As such, these changes
are neither intended to, nor expected to, impose any burden on
competition.

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

    No written comments were either solicited or received.

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

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the Exchange consents, the Commission shall: (a) By order approve
or disapprove such proposed rule change, or (b) institute proceedings
to determine whether the proposed rule change should be disapproved.

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-NASDAQ-2019-049 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NASDAQ-2019-049. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
    Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549, on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly.
    All submissions should refer to File Number SR-NASDAQ-2019-049 and
should be submitted on or before July 9, 2019.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\20\
---------------------------------------------------------------------------

    \20\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Eduardo A. Aleman,
Deputy Secretary.
[FR Doc. 2019-12788 Filed 6-17-19; 8:45 am]
 BILLING CODE 8011-01-P