[Federal Register Volume 87, Number 39 (Monday, February 28, 2022)]
[Proposed Rules]
[Pages 10998-11001]
[FR Doc No: 2022-04112]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R04-OAR-2021-0395; FRL-9563-01-R4]

Air Plan Approval; Kentucky; Emissions Statement Requirements for
the 2015 8-Hour Ozone Standard Nonattainment Areas

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve a State Implementation Plan (SIP) revision submitted to EPA by
the Commonwealth of Kentucky through the Kentucky Division for Air
Quality (KDAQ) on October 15, 2020. The proposed changes were submitted
by KDAQ to address the emissions statement requirements for the 2015 8-
hour ozone national ambient air quality standards (NAAQS) for Kentucky
counties in the Cincinnati, Ohio-Kentucky 2015 8-hour ozone NAAQS
nonattainment area (Cincinnati, OH-KY Area), and for some of the
Kentucky counties in the Louisville, Kentucky-Indiana 2015 8-hour ozone
NAAQS nonattainment area (Louisville, KY-IN Area). Specifically, EPA is
proposing to approve the emissions statement requirements for portions
of Boone, Campbell, and Kenton Counties in the Cincinnati, OH-KY Area,
and Bullitt and Oldham Counties in the Louisville, KY-IN Area. EPA will
consider and take action, or has considered and taken action, on
submissions addressing the emissions statement requirements for the
remaining counties in these two nonattainment areas, including the
Jefferson County, Kentucky portion of the Louisville, KY-IN Area, in
separate rulemakings. EPA is proposing approval pursuant to the Clean
Air Act (CAA or Act).

DATES: Comments must be received on or before March 30, 2022.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R04-
OAR-2021-0395 at www.regulations.gov. Follow the online instructions
for submitting comments. Once submitted, comments cannot be edited or
removed from Regulations.gov. EPA may publish any comment received to
its public docket. Do not submit electronically any information you
consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Multimedia
submissions (audio, video, etc.) must be accompanied by a written

comment. The written comment is considered the official comment and
should include discussion of all points you wish to make. EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e., on the web, cloud, or other file sharing
system). For additional submission methods, the full EPA public comment
policy, information about CBI or multimedia submissions, and general
guidance on making effective comments, please visit www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Tiereny Bell, Air Regulatory
Management Section, Air Planning and Implementation Branch, Air and
Radiation Division, U.S. Environmental Protection Agency, Region 4, 61
Forsyth Street SW, Atlanta, Georgia 30303-8960. The telephone number is
(404) 562-9088. Ms. Bell can also be reached via electronic mail at
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    On October 1, 2015, EPA promulgated a revised 8-hour primary and
secondary ozone NAAQS, strengthening both from 0.075 parts per million
(ppm) to 0.070 ppm (the 2015 8-hour Ozone NAAQS). See 80 FR 65292. The
2015 8-hour ozone NAAQS is set at 0.070 ppm based on an annual fourth-
highest daily maximum 8-hour average concentration averaged over three
years. Under EPA's regulations at 40 CFR part 50, the 2015 8-hour ozone
NAAQS is attained when the 3-year average of the annual fourth-highest
daily maximum 8-hour average ambient air quality ozone concentration is
less than or equal to 0.070 ppm. See 40 CFR 50.19. Ambient air quality
monitoring data for the 3-year period must meet a data completeness
requirement. The ambient air quality monitoring data completeness
requirement is met when the average percentage of days with valid
ambient monitoring data is greater than 90 percent, and no single year
has less than 75 percent data completeness as determined using Appendix
U of part 50.
    Upon promulgation of a new or revised ozone NAAQS, the CAA requires
EPA to designate as nonattainment any area that is violating the NAAQS
based on the three most recent years of ambient air quality data at the
conclusion of the designation process. On June 4, 2018 (effective
August 3, 2018), EPA designated the 7-county Cincinnati, OH-KY Area as
a Marginal ozone nonattainment area for the 2015 8-hour ozone NAAQS.\1\
Also on June 4, 2018 (effective August 3, 2018), EPA designated the 5-
county Louisville, KY-IN Area as a Marginal ozone nonattainment area
for the 2015 8-hour ozone NAAQS.\2\ The Cincinnati, OH-KY Area and the
Louisville, KY-IN Area were designated nonattainment for the 2015 8-
hour Ozone NAAQS using 2014-2016 ambient air quality data. See 83 FR
25776.
---------------------------------------------------------------------------

    \1\ The Cincinnati, OH-KY Area consists of the following
counties: Boone (Partial), Campbell (Partial), Kenton (Partial), in
Kentucky and the entire counties of Butler, Clermont, Hamilton, and
Warren in Ohio. EPA has taken action on the 2015 8-hour ozone NAAQS
nonattainment area emissions statement requirements for the entire
counties of Butler, Clermont, Hamilton, and Warren in Ohio in a
separate action. See 86 FR 12270 (March 3, 2021).
    \2\ The Louisville, KY-IN Area consists of Bullitt, Jefferson,
and Oldham Counties in Kentucky and Clark and Floyd Counties in
Indiana. EPA has proposed action on the 2015 8-hour ozone NAAQS
emissions statement requirements for the Jefferson County, Kentucky
portion of the Louisville, KY-IN area in a separate proposed
rulemaking, see 87 FR 2101 (January 13, 2022), and will take action
on the emissions statement requirements for Clark and Floyd Counties
in Indiana in a separate rulemaking.
---------------------------------------------------------------------------

    On December 6, 2018, EPA finalized a rule entitled ``Implementation
of the 2015 National Ambient Air Quality Standards for Ozone:
Nonattainment Area State Implementation Plan Requirements'' (SIP
Requirements Rule) that establishes the requirements that state,
tribal, and local air quality management agencies must meet as they
develop implementation plans for areas where air quality exceeds the
2015 8-hour ozone NAAQS.\3\ See 83 FR 62998. This rule establishes
nonattainment area attainment dates based on Table 1 of section 181(a)
of the CAA, including an attainment date three years after the August
3, 2018, designation effective date, for areas classified as Marginal
for the 2015 8-hour ozone NAAQS.
---------------------------------------------------------------------------

    \3\ The SIP Requirements Rule addresses a range of nonattainment
area SIP requirements for the 2015 ozone NAAQS, including
requirements pertaining to attainment demonstrations, reasonable
further progress, reasonably available control technology,
reasonably available control measures, major new source review,
emission inventories, and the timing of SIP submissions and
compliance with emission control measures in the SIP.
---------------------------------------------------------------------------

    Ground level ozone is not emitted directly into the air but is
created by chemical reactions between oxides of nitrogen
(NOX) and volatile organic compounds (VOC) in the presence
of sunlight. Emissions from industrial facilities and electric
utilities, motor vehicle exhaust, gasoline vapors, and chemical
solvents are some of the major sources of NOX and VOC.
Section 182(a)(3)(B) of the CAA requires states with ozone
nonattainment areas to submit a SIP revision requiring annual emissions
statements to be submitted to the state by the owner or operator of
each NOX and VOC stationary source. However, a state may
waive the emissions statement requirement for any class or category of
stationary sources which emit less than 25 tons per year (tpy) of VOC
or NOX if the state provides an inventory of emissions as
required by CAA section 182 that accounts for emissions from those
sources. See CAA section 182(a)(3)(B)(ii). The first statement is due
three years from the area's nonattainment designation, and subsequent
statements are due at least annually thereafter.
    Based on the nonattainment designation, Kentucky was required to
develop a SIP revision satisfying, among other things, CAA section
182(a)(3)(B). On October 15, 2020,\4\ Kentucky submitted a SIP revision
addressing the emissions statement requirements related to the 2015 8-
hour ozone NAAQS for the Kentucky portion of the Cincinnati, OH-KY Area
and for Bullitt and Oldham Counties in the Kentucky portion of the
Louisville, KY-IN Area. EPA is proposing to approve the October 15,
2020, SIP submittal as meeting the requirements of section 182(a)(3)(B)
of the CAA and associated federal regulations. EPA's analysis of the
SIP revision and how it addresses the emissions statement requirements
is discussed in the next section of this notice.
---------------------------------------------------------------------------

    \4\ KDAQ's transmittal letter for the October 15, 2020, SIP
revision was dated October 15, 2020, and submitted to EPA on October
16, 2020.
---------------------------------------------------------------------------

II. Analysis of the Commonwealth's Submittal

    As discussed above, section 182(a)(3)(B) of the CAA requires states
to submit a SIP revision requiring the owner or operator of each
NOX and VOC stationary source located in an ozone
nonattainment area to submit to the state annual emissions statements.
The first statement is due three years from the area's nonattainment
designation, and subsequent statements are due at least annually
thereafter.
    Due to previous nonattainment ozone designations, Kentucky has an
existing emissions statement program. The October 15, 2020, SIP
revision includes Kentucky's certification that the following SIP-
approved regulations contain provisions that meet the emissions
statement requirements of CAA section 182(a)(3)(B) for the 2015 8-hour
ozone NAAQS and that the Commonwealth continues to operate under these
approved provisions: 401 Kentucky Administrative Regulations (KAR)
52:020, Sections 22 and 23; 401

KAR 52:030, Sections 3 and 22; 401 KAR 52:040 Section 3; and 401 KAR
52:070 Section 3.\5\ On January 28, 2016, EPA approved Kentucky's
emissions statement program, which applies to sources located in ozone
nonattainment areas.\6\ See 81 FR 4896. The regulatory sections
identified in the October 15, 2020 submittal require sources that emit
25 tons per year or more of VOC or NOX within the Kentucky
portion of the Cincinnati, OH-KY Area and the Kentucky portion of the
Louisville, KY-IN Area, not including Jefferson County, to submit
annual certified statements showing actual VOC and NOX
emissions. EPA has preliminarily determined that the specific
regulatory sections identified in the October 15, 2020, submittal,
collectively, coupled with the waiver for stationary sources emitting
less than 25 tpy of NOX or VOC discussed in the two
paragraphs below, meet the emissions statement requirements of section
182(a)(3)(B).
---------------------------------------------------------------------------

    \5\ EPA notes that, in addition to the provisions identified in
Kentucky's October 15, 2020, SIP revision, the following are also
SIP-approved and apply to ozone nonattainment areas: the entirety of
401 KAR 52:030; and relevant provisions of 401 KAR 52:040, Sections
20 and 21. See 81 FR 4896 (January 28, 2016).
    \6\ EPA's 2016 approval of Kentucky's emissions statement
program pertained to the Kentucky portion of the 2008 Cincinnati,
OH-KY Area, but the Kentucky regulations approved in that 2016
action apply to all ozone nonattainment areas in Kentucky's
jurisdiction, which include the counties and partial counties in the
2015 Cincinnati, OH-KY and Louisville, KY-IN Areas that are within
Kentucky's jurisdiction.
---------------------------------------------------------------------------

    As allowed by CAA section 182(a)(3)(B)(ii), Kentucky waived the
emissions statement requirements for stationary sources emitting less
than 25 tpy of NOX or VOC. CAA section 182(a)(3)(B)(ii)
allows a state to waive the application of emissions statements
requirements to any class or category of stationary sources which emit
less than 25 tons per year of VOC or NOX if the state, in
its submissions under section 182(a)(1) or 182(a)(3)(A), provides an
inventory of emissions from such class or category of sources, based on
the use of the emission factors established by the Administrator or
other methods acceptable to the Administrator.
    Pursuant to CAA section 182(a)(3)(A), Kentucky is required to
submit a revised inventory meeting the requirements of section
182(a)(1) at the end of each 3-year period after submission of the
inventory under section 182(a)(1) until the Cincinnati, OH-KY Area and
the Louisville, KY-IN Area are redesignated to attainment. CAA section
182(a)(1) requires the submission of a comprehensive, accurate, current
inventory of actual emissions from all sources, as described in CAA
section 172(c)(3), in accordance with guidance provided by EPA.\7\ To
comply with CAA section 182(a)(3)(A)'s requirement to submit periodic
emissions inventories, Kentucky submits NOX and VOC
emissions data to EPA's National Emissions Inventory (NEI) \8\
consistent with 83 FR 62998, ``Implementation of the 2015 National
Ambient Air Quality Standards for Ozone: Nonattainment Area State
Implementation Plan Requirements,'' and 40 CFR 51.1315. That emissions
data includes small stationary sources (namely, those emitting less
than 25 tpy of NOX or VOC) in accordance with CAA section
182(a)(3)(B)(ii).
---------------------------------------------------------------------------

    \7\ CAA section 172(c)(3) states, ``Such plan provisions shall
include a comprehensive, accurate, current inventory of actual
emissions from all sources of the relevant pollutant or pollutants
in such area including such periodic revisions as the Administrator
may determine necessary to assure that the requirements of this part
are met.''
    \8\ To access EPA's NEI, please visit: U.S. EPA, National
Emissions Inventory (NEI), https://www.epa.gov/air-emissions-inventories/national-emissions-inventory-nei.
---------------------------------------------------------------------------

    For the reasons discussed above, EPA has preliminarily determined
that Kentucky's emissions statement regulations meet the requirements
under CAA section 182(a)(3)(B) and the SIP Requirements Rule for the
2015 8-hour ozone NAAQS for the entire Kentucky portion of the
Cincinnati, OH-KY Area and the Bullitt County, Kentucky and Oldham
County, Kentucky portion of the Louisville, KY-IN Area.

III. Proposed Action

    EPA is proposing to approve Kentucky's October 15, 2020, SIP
revision addressing the emissions statement requirements for the 2015
8-hour ozone NAAQS for portions of Boone, Campbell, and Kenton Counties
in the Cincinnati, OH-KY 2015 8-hour ozone nonattainment area, and
Bullitt and Oldham Counties in the Louisville, KY-IN 2015 8-hour ozone
nonattainment area. EPA is proposing to find that the Commonwealth's
submission meets the requirements of sections 110 and 182 of the CAA.

IV. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations. See 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided they meet the criteria of the CAA. This action merely proposes
to approve state law as meeting Federal requirements and does not
impose additional requirements beyond those imposed by state law. For
that reason, this proposed action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    The SIP is not approved to apply on any Indian reservation land or
in any other area where EPA or an Indian tribe has demonstrated that a
tribe has jurisdiction. In those areas of Indian country, the rule does
not have tribal implications as specified by Executive Order 13175 (65
FR 67249, November 9, 2000), nor will it impose substantial direct
costs on tribal governments or preempt tribal law.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Nitrogen dioxide, Ozone,
Reporting and recordkeeping requirements, Volatile organic compounds.

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

    Dated: February 17, 2022.
Daniel Blackman,
Regional Administrator, Region 4.
[FR Doc. 2022-04112 Filed 2-25-22; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 83, Number 75 (Wednesday, April 18, 2018)]
[Rules and Regulations]
[Pages 17078-17081]
[FR Doc No: 2018-08110]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2018-0322]
RIN 1625-AA00

Safety Zone, Delaware River; Diving and Survey Operations; Marcus
Hook, PA

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule; request for comments.

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

SUMMARY: The Coast Guard is establishing a safety zone encompassing all
navigable waters within a 250-yard radius of the Commerce Construction
vessels and associated equipment conducting survey and diving
operations in the Delaware River, and in the vicinity of Anchorage 7,
near Marcus Hook, PA. The safety zone is needed to protect personnel,
vessels, associated equipment, and the marine environment from
potential hazards created by survey and diving operations. Entry of
persons or vessels into this safety zone will be prohibited unless
specifically authorized by the Captain of the Port Delaware Bay. We
invite your comments on this rule.

DATES: This rule is effective from April 30, 2018 through June 30,
2018. Comments and related material must be received by the Coast Guard
on or before May 18, 2018.

ADDRESSES: You may submit comments identified by docket number USCG-
2018-0322 using the Federal eRulemaking Portal at http://www.regulations.gov. See the ``Public Participation and Request for
Comments'' portion of the SUPPLEMENTARY INFORMATION section for further
instructions on submitting comments.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
rulemaking, call or email Petty Officer Edmund Ofalt, Waterways
Management Branch, U.S. Coast Guard Sector Delaware Bay; telephone
(215) 271-4814, email [email protected].

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

APA Administrative Procedure Act
CFR Code of Federal Regulations
COTP Captain of the Port
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

    The Coast Guard is issuing this temporary rule without prior notice
and pursuant to authority under section 4(a) of the Administrative
Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an
agency to issue a rule without prior notice when the agency for good
cause finds that those procedures are ``impracticable, unnecessary, or
contrary to the public interest.'' Under 5 U.S.C. 553(b)(B), the Coast
Guard finds that good cause exists for not publishing a notice of
proposed rulemaking (NPRM) with respect to this rule due to the short
time period between when Sector Delaware Bay received complete details
of this operation, March 28, 2018, and the date when this safety zone
needs to go into effect by. It is impracticable and contrary to the
public interest to publish an NPRM before issuing this rule because we
must establish the safety zone by April 30, 2018, to ensure the safety
of personnel, vessels, associated equipment, and the marine environment
from potential hazards created by survey and diving operations the
Coast Guard is providing an opportunity to comment prior to the rule
becoming effective and while the rule is in effect and may amend the
rule after it is effective if necessary.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Delaying the effective date of
this rule would be impracticable and contrary to the public interest
because immediate action is needed to mitigate hazards presented by
survey and diving operations.

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 Delaware Bay (COTP) has determined that a
safety zone is necessary to mitigate the hazards involving survey and
diving operations. The safety zone covers all navigable waters within
250-yards of vessels and associated equipment being used by personnel
to conduct survey and diving operations.

IV. Discussion of the Rule

    This rule establishes a safety zone from April 30, 2018, through
June 30, 2018. The safety zone will cover all navigable waters within
250-yards of survey and diving operation vessels, as well as any
associated equipment, operating in Marcus Hook Anchorage No. 7 near
Marcus Hook, PA, and within the Marcus Hook Range on the Delaware
River. Diving and survey operations conducted within the anchorage will
be in the southernmost portion of the anchorage on the eastern side
adjacent to the New Jersey shoreline. The affiliated safety zone will
restrict available anchorage grounds in the lower portion of Anchorage
No. 7. During diving and survey operations conducted within navigable
channel of the Marcus Hook Range, vessels will not be permitted to
anchor within the southern portion of the anchorage as this section
will be utilized to allow traffic to safely pass around the safety
zone. Information on procedures for requesting permission to anchor, as
well as any changes to traffic patterns, will be distributed to the
maritime community via the methods stated below.
    Notification regarding the specific location of the zone and any
changes to traffic patterns will be sent to the maritime community via
Broadcast Notice to Mariners and Marine Safety information Bulletins.
Marine Safety Information Bulletins may be obtained from https://homeport.uscg.mil/port-directory/delaware-bay or by calling the Coast
Guard Delaware Bay Command Center at<PHONE_NUMBER>.

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 13771 directs agencies to control
regulatory costs through a budgeting process. This rule has not been
designated a ``significant regulatory action,'' under Executive Order
12866. Accordingly, the rule has not been reviewed by the Office of
Management and Budget (OMB), and pursuant to OMB guidance it is exempt
from the requirements of Executive Order 13771.
    This regulatory action determination is based on size, location and
duration of the safety zone. The safety zone will impact a small
designated area of Marcus Hook Anchorage No. 7 and the Marcus Hook
Range on the Delaware River. During enforcement periods of the safety
zone these impacts include restrictions to the location, type and size
of vessels that may anchor in the Marcus Hook Anchorage. However, other
anchorages in the Delaware River will remain fully operational as
alternatives for vessel traffic. Vessel traffic will be able to safely
transit around the safety zone. Moreover, the Coast Guard will issue a
Broadcast Notice to Mariners via VHF-FM marine channel 16, Local Notice
to Mariners, and Marine Safety Information Bulletin about the zone.

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
would 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 would not have a significant economic impact on
any vessel owner or operator.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this rule would have
a significant economic impact on it, please submit a comment (see
ADDRESSES) explaining why you think it qualifies and how and to what
degree this rule would economically affect it.
    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. 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 would 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 would 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.

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 would not result
in such an 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
Directive 023-01 and Commandant Instruction M16475.1D, which guide the
Coast Guard in complying with the National Environmental Policy Act of
1969 (42 U.S.C. 4321-4370f), and have made a preliminary determination
that this action is one of a category of actions that do not
individually or cumulatively have a significant effect on the human
environment. This rule involves a safety zone that will prohibit entry
within 250-yards of survey and diving operation vessels, as well as any
associated equipment, operating in Marcus Hook Anchorage No. 7 and
Marcus Hook Range, on the Delaware River. Normally such actions are
categorically excluded from further review under paragraph L60(a) of
Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 01. A
preliminary Record of Environmental Consideration supporting this
determination is available in the docket where indicated under
ADDRESSES. We seek any comments or information that may lead to the
discovery of a significant environmental impact from this rule.

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.

VI. Public Participation and Request for Comments

    We view public participation as essential to effective rulemaking,
and will consider all comments and material received during the comment
period. The Coast Guard may amend this temporary final rule if we
receive comments from the public that indicate that a change is
warranted. If you submit a comment, please include the docket number
for this rulemaking, indicate the specific section of this document to
which each comment applies, and provide a reason for each suggestion or
recommendation.
    We encourage you to submit comments through the Federal eRulemaking
Portal at http://www.regulations.gov. If your material cannot be
submitted using http://www.regulations.gov, contact the person in the
FOR FURTHER INFORMATION CONTACT section of this document for alternate
instructions.
    We accept anonymous comments. All comments received will be posted
without change to http://www.regulations.gov and will include any
personal information you have provided. For more about privacy and the
docket, visit http://www.regulations.gov/privacyNotice.
    Documents mentioned in this temporary final rule as being available
in the docket, and all public comments, will be in our online docket at
http://www.regulations.gov and can be viewed by following that
website's instructions. Additionally, if you go to the online docket
and sign up for email alerts, you will be notified when comments are
posted.

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.T05-0322 to read as follows:

Sec.  165.T05-0322   Safety Zone, Delaware River; Diving and Survey
Operations; Marcus Hook, PA.

    (a) Location. The following areas are safety zones: All navigable
waters within 250-yards of Commerce Construction crane barge KELLY and
the towing vessel JOKER, as well as any associated equipment, operating
in Marcus Hook Anchorage No. 7 or Marcus Hook Range, on the Delaware
River.
    (b) Definitions. (1) Captain of the Port means the Commander,
Sector Delaware Bay or any Coast Guard commissioned, warrant, or petty
officer who has been authorized by the Captain of the Port to act on
his behalf.
    (2) Designated representative means any Coast Guard commissioned,
warrant or petty officer who has been authorized by the Captain of the
Port, Delaware Bay, to assist with the enforcement of safety zones
described in paragraph (a) of this section.
    (c) Regulations. The general safety zone regulations found in
subpart C of this part apply to the safety zones created by this
section.
    (1) Entry into or transiting within the zones is prohibited unless
vessels obtain permission from the Captain of the Port via VHF-FM
channel 16 or make satisfactory passing arrangements via VHF-FM
channels 13 or 16 with the crane barge KELLY or towing vessel JOKER.
    (2) Any vessel wishing to anchor within Marcus Hook Anchorage No. 7
is required to verify compliance with current temporary restrictions
and requirements noted within the most current Sector Delaware Bay
Marine Safety Information Bulletin. The most current Marine Safety
Information Bulletin may be obtained at https://homeport.uscg.mil/port-directory/delaware-bay or by calling the Coast Guard Delaware Bay
Command Center at<PHONE_NUMBER>.

    (3) All vessels authorized to enter or transit the zones must
operate at the minimum safe speed necessary to maintain steerage and
reduce wake.
    (4) This section applies to all vessels except those engaged in law
enforcement, aids to navigation servicing, and emergency response
operations.
    (d) Enforcement periods. This section will be enforced from April
30, 2018, through June 30, 2018.

    Dated: April 12, 2018.
Scott E. Anderson,
Captain, U.S. Coast Guard, Captain of the Port Delaware Bay.
[FR Doc. 2018-08110 Filed 4-17-18; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register: July 19, 2007 (Volume 72, Number 138)]
[Notices]
[Page 39613]
[DOCID:fr19jy07-34]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. TS04-286-002]

Exelon Corporation; Notice of Filing

July 12, 2007.
    Take notice that on June 29, 2007, Exelon Corporation, on behalf of
its subsidiaries PECO Energy Company and Commonwealth Energy Company,
filed a request for clarification of waiver with respect to the
application of existing waivers issued to the two companies under the
Commission's Standards of Conduct with respect to renewable energy
credits.
    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 20, 2007.

Kimberly D. Bose,
Secretary.
[FR Doc. E7-13969 Filed 7-18-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 110 (Monday, June 9, 2014)]
[Notices]
[Page 32964]
[FR Doc No: 2014-13291]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0194]

Agency Information Collection Activities; Announcement of Office
of Management and Budget Approval; Safety Assurance Case

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a
collection of information entitled ``Safety Assurance Case'' has been
approved by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On April 10, 2014, the Agency submitted a
proposed collection of information entitled ``Safety Assurance Case''
to OMB for review and clearance under 44 U.S.C. 3507. An Agency may not
conduct or sponsor, and a person is not required to respond to, a
collection of information unless it displays a currently valid OMB
control number. OMB has now approved the information collection and has
assigned OMB control number 0910-0766. The approval expires on May 31,
2017. A copy of the supporting statement for this information
collection is available on the Internet at http://www.reginfo.gov/public/do/PRAMain.

    Dated: June 3, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-13291 Filed 6-6-14; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 82, Number 35 (Thursday, February 23, 2017)]
[Notices]
[Page 11450]
[FR Doc No: 2017-03483]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OECA-2007-0468; FRL--9959-49-OEI]

Information Collection Request Submitted to OMB for Review and
Approval; Comment Request; Environmental Impact Assessment of
Nongovernmental Activities in Antarctica (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The Environmental Protection Agency has submitted an
information collection request (ICR), ``Environmental Impact Assessment
of Nongovernmental Activities in Antarctica (Renewal)'' (EPA ICR No.
1808.08, OMB Control No. 2020-0007) to the Office of Management and
Budget (OMB) for review and approval in accordance with the Paperwork
Reduction Act (44 U.S.C. 3501 et seq.). This is a proposed extension of
the ICR, which is currently approved through March 31, 2017. Public
comments were previously requested via the Federal Register (81 FR
68412) on October 4, 2016 during a 60-day comment period. This notice
allows for an additional 30 days for public comments. A fuller
description of the ICR is given below, including its estimated burden
and cost to the public. An Agency may not conduct or sponsor and a
person is not required to respond to a collection of information unless
it displays a currently valid OMB control number.

DATES: Comments must be submitted on or before March 27, 2017.

ADDRESSES: Submit your comments, referencing Docket ID Number EPA-HQ-
OECA-2007-0468, to (1) EPA online using www.regulations.gov (our
preferred method), by email to<EMAIL_ADDRESS>or by mail to: EPA
Docket Center, Environmental Protection Agency, Mail Code 28221T, 1200
Pennsylvania Ave. NW., Washington, DC 20460, and (2) OMB via email to
<EMAIL_ADDRESS>Address comments to OMB Desk Officer for
EPA.
    EPA's policy is that all comments received will be included in the
public docket without change including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: Julie Roemele, Office of Federal
Activities, Mail Code 2252A, Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460; telephone number: (202)
564-5632; fax number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Supporting documents which explain in detail
the information that the EPA will be collecting are available in the
public docket for this ICR. The docket can be viewed online at
www.regulations.gov or in person at the EPA Docket Center, WJC West,
Room 3334, 1301 Constitution Ave. NW., Washington, DC. The telephone
number for the Docket Center is<PHONE_NUMBER>. For additional
information about EPA's public docket, visit http://www.epa.gov/dockets.
    Abstract: The Environmental Protection Agency's (EPA's) regulations
at 40 CFR part 8, Environmental Impact Assessment of Nongovernmental
Activities in Antarctica (Rule), were promulgated pursuant to the
Antarctic Science, Tourism, and Conservation Act of 1996 (Act), 16
U.S.C. 2401 et seq., as amended, 16 U.S.C. 2403a, which implements the
Protocol on Environmental Protection (Protocol) to the Antarctic Treaty
of 1959 (Treaty). The Rule provides for assessment of the environmental
impacts of nongovernmental activities in Antarctica, including tourism,
for which the United States is required to give advance notice under
Paragraph 5 of Article VII of the Treaty, and for coordination of the
review of information regarding environmental impact assessments
received from other Parties under the Protocol. The requirements of the
Rule apply to operators of nongovernmental expeditions organized or
proceeding from the territory of the United States to Antarctica and
include commercial and non-commercial expeditions. The rule provides
nongovernmental operators with the specific requirements they need to
meet in order to comply with the requirements of Article 8 and Annex I
to the Protocol. The provisions of the Rule are intended to ensure that
potential environmental effects of nongovernmental activities
undertaken in Antarctica are appropriately identified and considered by
the operator during the planning process and that to the extent
practicable appropriate environmental safeguards which would mitigate
or prevent adverse impacts on the Antarctic environment are identified
by the operator.
    Form Numbers: None.
    Respondents/Affected Entities: Nongovernmental operators with
activities in Antarctica.
    Respondent's Obligation to Respond: Mandatory (40 CFR part 8).
    Estimated Number of Respondents: 19 (total).
    Frequency of Response: Annual.
    Total Estimated Burden: 1,217 hours (per year). Burden is defined
at 5 CFR 1320.03(b).
    Total Estimated Cost: $93,444 (per year), includes $0 annualized
capital or operation & maintenance costs.
    Changes in Estimates: There is a decrease of 37 hours in the total
estimated respondent burden compared with the ICR currently approved by
OMB. This decrease is the result of a change to the level of
environmental documentation EPA anticipates the operators will submit.

Courtney Kerwin,
Director, Regulatory Support Division.
[FR Doc. 2017-03483 Filed 2-22-17; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register: December 12, 2005 (Volume 70, Number 237)]
[Notices]
[Page 73490-73491]
[DOCID:fr12de05-96]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-52895; File No. SR-BSE-2005-48]

Self-Regulatory Organizations; Boston Stock Exchange, Inc.;
Notice of Filing of Proposed Rule Change and Amendment No. 1 Thereto
Requiring Its Member To Provide Electronic Mail Addresses to the
Exchange

December 5, 2005.
    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 October 28, 2005, the Boston Stock Exchange, Inc. (``BSE'' or
``Exchange'') 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. On
November 23, 2005, the BSE filed Amendment No. 1 to the proposed rule
change.\3\ The Commission is publishing this notice to solicit comments
on the proposed rule change, as amended, from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ In Amendment No. 1, BSE made clarifying changes to its
statement of purpose for the proposed rule change.
---------------------------------------------------------------------------

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

    The BSE proposes to amend its rules to require members and member
organizations to provide e-mail addresses to the Exchange for use in
transmitting notices and other communications. Below is the text of the
proposed rule change. Proposed new language is in italics.

Rules of the Boston Stock Exchange

Chapter XXV--Registration of Member-Corporations

    SEC. 1. A member of the Exchange may register a corporation as a
member-corporation of the Exchange, upon application by the member and
the corporation, subject to the following terms and conditions:
    (a)--(n) No change.

Designation of Electronic Mail Addresses

    (o) Every member and member organization shall designate one or
more electronic mail addresses for the purpose of receiving Exchange
notices and communications and shall promptly update those electronic
mail addresses when those addresses change

or are no longer valid. An authorized representative of the Exchange
may elect to transmit notices or other communications to members and
member organizations electronically; provided, however, that nothing in
this rule shall be construed to supersede or modify either the method
for service of process or other materials in any disciplinary
proceeding or any other provisions of Exchange rules setting out a
specific method for the receipt of information from the Exchange.
* * * * *

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

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

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

1. Purpose
    The Exchange proposes to modify its rules to require each member
and member organization to provide the Exchange with an electronic mail
address that the Exchange may use to distribute notices and
communications. In addition, each member and member organization would
be required to promptly update those electronic mail addresses when
those addresses change or are no longer valid. The Exchange represents
that the proposal is designed to allow the Exchange to take advantage
of technology to communicate with members in a more efficient and cost-
effective manner, for routine communications as well as in appropriate
emergency situations. Among other things, the Exchange anticipates that
it would be able to provide members with electronic copies of the
Regulatory Circulars, which today are circulated to Exchange Members in
hard copies.
    Importantly, the Exchange's proposed rule change specifically notes
that it does not supersede or modify any rule that sets out a different
method of service required as part of a disciplinary proceeding,\4\ or
any other provisions of the Exchange rules setting out a specific
method for the receipt of information from the Exchange. The Exchange
represents that those materials would continue to be provided by the
more conventional means set out in the rules.
---------------------------------------------------------------------------

    \4\ See Chapter XXX of BSE rules (``Disciplining of Members-
Denial of Membership'').
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes the proposal, as amended, is consistent with
Section 6(b) of the Act \5\, in general, and furthers the objectives of
Section 6(b)(5) of the Act,\6\ in particular, because it would promote
just and equitable principles of trade, serve to remove impediments to
and perfect the mechanism of a free and open market and a national
market system, and to protect investors and the public interest by
allowing the Exchange to take advantage of available technology to
communicate with its members in a more efficient and cost-effective
manner.
---------------------------------------------------------------------------

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

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

    The Exchange does not believe that the proposed rule change, as
amended, will 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 solicited or received by the Exchange on
this proposal.

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

    Within 35 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 will:
    (A) By order approve the proposed rule change, as amended, or
    (B) Institute proceedings to determine whether the proposed rule
change, as amended, 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, as amended, 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-BSE-2005-48 on the subject line.

Paper Comments

     Send paper comments in triplicate to Jonathan G. Katz,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-9303.
    All submissions should refer to File Number SR-BSE-2005-48. 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 inspection
and copying in the Commission's Public Reference Room. 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-BSE-2005-48 and should be submitted on or before January
3, 2006.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\7\
---------------------------------------------------------------------------

    \7\ 17 CFR 200.30-3(a)(12).

Jonathan G. Katz,
Secretary.
 [FR Doc. E5-7188 Filed 12-9-05; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 88, Number 5 (Monday, January 9, 2023)]
[Notices]
[Pages 1308-1312]
[FR Doc No: 2023-00118]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-96598; File No. SR-GEMX-2022-14]

Self-Regulatory Organizations; Nasdaq GEMX, LLC; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Reduce GEMX's
Options Regulatory Fee

January 3, 2023.
    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 December 22, 2022, Nasdaq GEMX, LLC (``GEMX'' or ``Exchange'') filed
with the Securities and Exchange Commission (``SEC'' or ``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 Exchange proposes to amend GEMX's Pricing Schedule at Options
7, Section 5 to reduce the GEMX Options Regulatory Fee or ``ORF''.
    While the changes proposed herein are effective upon filing, the
Exchange has designated the amendments become operative on February 1,
2023.
    The text of the proposed rule change is available on the Exchange's
website at https://listingcenter.nasdaq.com/rulebook/gemx/rules, 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
    GEMX proposes to lower its ORF from $0.0014 to $0.0013 per contract
side on February 1, 2023. Previously, GEMX has filed to lower or waive
its ORF in 2019, 2021 and 2022.\3\ After a review of its regulatory
revenues and regulatory costs, the Exchange proposes to reduce the ORF
to ensure that revenue collected from the ORF, in combination with
other regulatory fees and fines, does not exceed the Exchange's total
regulatory costs.
---------------------------------------------------------------------------

    \3\ See Securities Exchange Act Release No. 85140 (February 14,
2019), 84 FR 5511 (February 21, 2019) (SR-GEMX-2019-01) (Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change To
Amend the Options Regulatory Fee); 92698 (August 18, 2021), 86 FR
47355 (August 24, 2021) (SR-GEMX-2021-08) (Notice of Filing and
Immediate Effectiveness of Proposed Rule Change to Amend GEMX's
Options Regulatory Fee); and 94069 (January 26, 2022), 87 FR 5545
(February 1, 2022) (SR-GEMX-2022-03) (Notice of Filing and Immediate
Effectiveness of Proposed Rule Change To Reduce GEMX's Options
Regulatory Fee).
---------------------------------------------------------------------------

    Volumes in the options industry went over 900,000,000 total
contracts as of August 2022 and remained over that threshold through
November 2022. GEMX has taken measures in prior years to lower and
waive its ORF to ensure that revenue collected from the ORF, in
combination with other regulatory fees and fines, does not exceed the
Exchange's total regulatory costs. Despite those prior measures, GEMX
will need to reduce its ORF again to account for trading volumes in
2022. At this time, GEMX believes that the options volume it
experienced in the second half of 2022 is likely to persist in 2023.
The anticipated options volume would continue to impact GEMX's ORF
collection which, in turn, has caused GEMX to propose reducing the ORF
to ensure that revenue collected from the ORF, in combination with
other regulatory fees and fines, would not exceed the Exchange's total
regulatory costs.
Collection of ORF
    GEMX will continue to assess its ORF for each customer option
transaction that is either: (1) executed by a Member on GEMX; or (2)
cleared by an GEMX Member at The Options Clearing Corporation (``OCC'')
in the customer range,\4\ even if the transaction was executed by a
non-Member of GEMX, regardless of the exchange on which the transaction
occurs.\5\ If the OCC clearing member is a GEMX Member, ORF is assessed
and collected on all cleared customer contracts (after adjustment for
CMTA \6\); and (2) if the OCC clearing member is not a GEMX Member, ORF
is collected only on the cleared customer contracts executed at GEMX,
taking into
---------------------------------------------------------------------------

    \4\ Participants must record the appropriate account origin code
on all orders at the time of entry of the order. The Exchange
represents that it has surveillances in place to verify that members
mark orders with the correct account origin code.
    \5\ The Exchange uses reports from OCC when assessing and
collecting the ORF.
    \6\ CMTA or Clearing Member Trade Assignment is a form of
``give-up'' whereby the position will be assigned to a specific
clearing firm at OCC.

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

account any CMTA instructions which may result in collecting the ORF
from a non-Member.\7\
---------------------------------------------------------------------------

    \7\ By way of example, if Broker A, a GEMX Member, routes a
customer order to CBOE and the transaction executes on CBOE and
clears in Broker A's OCC Clearing account, ORF will be collected by
GEMX from Broker A's clearing account at OCC via direct debit. While
this transaction was executed on a market other than GEMX, it was
cleared by a GEMX Member in the member's OCC clearing account in the
customer range, therefore there is a regulatory nexus between GEMX
and the transaction. If Broker A was not a GEMX Member, then no ORF
should be assessed and collected because there is no nexus; the
transaction did not execute on GEMX nor was it cleared by a GEMX
Member.
---------------------------------------------------------------------------

    In the case where a Member both executes a transaction and clears
the transaction, the ORF will be assessed to and collected from that
Member. In the case where a Member executes a transaction and a
different Member clears the transaction, the ORF will be assessed to
and collected from the Member who clears the transaction and not the
Member who executes the transaction. In the case where a non-Member
executes a transaction at an away market and a Member clears the
transaction, the ORF will be assessed to and collected from the Member
who clears the transaction. In the case where a Member executes a
transaction on GEMX and a non-Member clears the transaction, the ORF
will be assessed to the Member that executed the transaction on GEMX
and collected from the non-Member who cleared the transaction. In the
case where a Member executes a transaction at an away market and a non-
Member clears the transaction, the ORF will not be assessed to the
Member who executed the transaction or collected from the non-Member
who cleared the transaction because the Exchange does not have access
to the data to make absolutely certain that ORF should apply. Further,
the data does not allow the Exchange to identify the Member executing
the trade at an away market.
ORF Revenue and Monitoring of ORF
    The Exchange monitors the amount of revenue collected from the ORF
to ensure that it, in combination with other regulatory fees and fines,
does not exceed regulatory costs. In determining whether an expense is
considered a regulatory cost, the Exchange reviews all costs and makes
determinations if there is a nexus between the expense and a regulatory
function. The Exchange notes that fines collected by the Exchange in
connection with a disciplinary matter offset ORF.
    Revenue generated from ORF, when combined with all of the
Exchange's other regulatory fees and fines, is designed to recover a
material portion of the regulatory costs to the Exchange of the
supervision and regulation of member customer options business
including performing routine surveillances, investigations,
examinations, financial monitoring, and policy, rulemaking,
interpretive, and enforcement activities. Regulatory costs include
direct regulatory expenses and certain indirect expenses in support of
the regulatory function. The direct expenses include in-house and
third-party service provider costs to support the day-to-day regulatory
work such as surveillances, investigations and examinations. The
indirect expenses include support from such areas as Office of the
General Counsel, technology, and internal audit. Indirect expenses were
approximately 39% of the total regulatory costs for 2022. Thus, direct
expenses were approximately 61% of total regulatory costs for 2022.\8\
---------------------------------------------------------------------------

    \8\ The Exchange will finalize its 2023 Regulatory Budget in the
first quarter of 2023.
---------------------------------------------------------------------------

    The ORF is designed to recover a material portion of the costs to
the Exchange of the supervision and regulation of its Members,
including performing routine surveillances, investigations,
examinations, financial monitoring, and policy, rulemaking,
interpretive, and enforcement activities.
Proposal
    Based on the Exchange's most recent review, the Exchange is
proposing to reduce the amount of ORF that will be collected by the
Exchange from $0.0014 per contract side to $0.0013 per contract side.
The Exchange issued an Options Trader Alert on December 20, 2022
indicating the proposed rate change for February 1, 2023.\9\
---------------------------------------------------------------------------

    \9\ See Options Trader Alert 2022-44.
---------------------------------------------------------------------------

    The proposed reduction is based on current levels of options
volume. The below table displays monthly volume from 2021.\10\
---------------------------------------------------------------------------

    \10\ The OCC data from December 2021 numbers reflect only 13
trading days as this information is through December 17, 2021.
Volume data in the table represents numbers of contracts; each
contract has two sides.
---------------------------------------------------------------------------

BILLING CODE 8011-01-P
[GRAPHIC] [TIFF OMITTED] TN09JA23.000

    The Exchange compared the options volume in 2022 to the options
volume in 2021. The below table displays monthly volume for 2022 to
date.\11\
---------------------------------------------------------------------------

    \11\ The OCC data reflects data from January through November
2022. Volume data in the table represents numbers of contracts; each
contract has two sides.
[GRAPHIC] [TIFF OMITTED] TN09JA23.001

BILLING CODE 8011-01-C
    Comparing 2021 to 2022, the options volumes in 2022 remained higher
in a majority of the months in 2022.\12\ November volume for 2022,
while lower than November volume for 2021, remains higher than most
months in 2021. With respect to customer options volume across the
industry, total customer options contract average daily volume, to
date, in 2022 is 36,509,256 as compared to total customer options
contract average daily volume in 2021 which was 36,308,323.\13\
---------------------------------------------------------------------------

    \12\ February, June, July and November 2022 volumes are lower as
compared to 2021 volumes in those same months.
    \13\ See data from OCC at: https://www.theocc.com/Market-Data/Market-Data-Reports/Volume-and-Open-Interest/Volume-by-Account-Type.
---------------------------------------------------------------------------

    There can be no assurance that the Exchange's costs for 2023 will
not differ materially from these expectations and prior practice, nor
can the Exchange predict with certainty whether options volume will
remain at the current level going forward. The Exchange notes however,
that when combined with regulatory fees and fines, the revenue that may
be generated utilizing an ORF rate of $0.0014 per contract side may
result in revenue which exceeds the Exchange's estimated regulatory
costs for 2023 if options volumes remain the same. The options volume
for 2022 remains high when compared to 2021 volumes. GEMX lowered ORF
in the beginning of 2022 to account for the options volume in 2021. The
Exchange therefore proposes to reduce its ORF to $0.0013 per contract
side to ensure that revenue does not exceed the Exchange's estimated
regulatory costs in 2023. Particularly, the Exchange believes that
reducing the ORF when combined with all of the Exchange's other
regulatory fees and fines, would allow the Exchange to continue
covering a material portion of its regulatory costs, while lessening
the potential for generating excess revenue that may otherwise occur
using the rate of $0.0014 per contract side.\14\
---------------------------------------------------------------------------

    \14\ The Exchange notes that its regulatory responsibilities
with respect to Member compliance with options sales practice rules
have largely been allocated to FINRA under a 17d-2 agreement. The
ORF is not designed to cover the cost of that options sales practice
regulation.
---------------------------------------------------------------------------

    The Exchange will continue to monitor the amount of revenue
collected from the ORF to ensure that it, in combination with its other
regulatory fees and fines, does not exceed regulatory costs. If the
Exchange determines regulatory revenues may exceed or are projected to
exceed regulatory costs, the Exchange will adjust the ORF by submitting
a fee change filing to the Commission and notifying \15\ its Members
via an Options Trader Alert.\16\
---------------------------------------------------------------------------

    \15\ The Exchange will provide Members with such notice at least
30 calendar days prior to the effective date of the change.
    \16\ The Exchange notes that in connection with this proposal,
it provided the Commission confidential details regarding the
Exchange's projected regulatory revenue, including projected revenue
from ORF, along with a projected regulatory expenses.
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
the Securities Exchange Act of 1934 (the ``Act'') and the rules and
regulations thereunder applicable to the Exchange and, in particular,
the requirements of Section 6(b) of the Act.\17\ Specifically, the
Exchange believes the proposed rule change is consistent with Section
6(b)(4) of the Act,\18\ which provides that Exchange rules may provide
for the equitable allocation of reasonable dues, fees, and other
charges among its members, and other persons using its facilities.
Additionally, the Exchange believes the proposed rule change is
consistent with the Section 6(b)(5) \19\ requirement that the rules of
an exchange not be designed to permit unfair discrimination between
customers, issuers, brokers, or dealers.
---------------------------------------------------------------------------

    \17\ 15 U.S.C. 78f(b).
    \18\ 15 U.S.C. 78f(b)(4).
    \19\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The Exchange believes the proposed fee change is reasonable because
customer transactions will be subject to a lower ORF fee than the rate
that would otherwise be in effect on February 1, 2023. Moreover, the
proposed reduction is necessary for the Exchange to avoid collecting
revenue, in combination with other regulatory fees and fines, that
would be in excess of its anticipated regulatory costs which is
consistent with the Exchange's practices.
    The Exchange designed the ORF to generate revenues that would be
less than the amount of the Exchange's regulatory costs to ensure that
it, in combination with its other regulatory fees and fines, does not
exceed regulatory costs, which is consistent with the view of the
Commission that regulatory fees be used for regulatory purposes and not
to support the Exchange's business operations. As discussed above,
however, after review of its regulatory costs and regulatory revenues,
which includes revenues from ORF and other regulatory fees and fines,
the Exchange determined that absent a reduction in ORF, it may collect
revenue which would exceed its regulatory costs. Indeed, the Exchange
notes that when taking into account the potential that recent options
volume persists, it estimates the ORF may

generate revenues that would cover more than the approximated
Exchange's projected regulatory costs. As such, the Exchange believes
it's reasonable and appropriate to reduce the ORF amount from $0.0014
to $0.0013 per contract side.
    The Exchange also believes the proposed fee change is equitable and
not unfairly discriminatory in that it is charged to all Members on all
their transactions that clear in the customer range at OCC.\20\ The
Exchange believes the ORF ensures fairness by assessing higher fees to
those Members that require more Exchange regulatory services based on
the amount of customer options business they conduct. Regulating
customer trading activity is much more labor intensive and requires
greater expenditure of human and technical resources than regulating
non-customer trading activity, which tends to be more automated and
less labor-intensive. For example, there are costs associated with main
office and branch office examinations (e.g., staff expenses), as well
as investigations into customer complaints and the terminations of
registered persons. As a result, the costs associated with
administering the customer component of the Exchange's overall
regulatory program are materially higher than the costs associated with
administering the non-customer component (e.g., Member proprietary
transactions) of its regulatory program. Moreover, the Exchange notes
that it has broad regulatory responsibilities with respect to
activities of its Members, irrespective of where their transactions
take place. Many of the Exchange's surveillance programs for customer
trading activity may require the Exchange to look at activity across
all markets, such as reviews related to position limit violations and
manipulation. Indeed, the Exchange cannot effectively review for such
conduct without looking at and evaluating activity regardless of where
it transpires. In addition to its own surveillance programs, the
Exchange also works with other SROs and exchanges on intermarket
surveillance related issues. Through its participation in the
Intermarket Surveillance Group (``ISG'') \21\ the Exchange shares
information and coordinates inquiries and investigations with other
exchanges designed to address potential intermarket manipulation and
trading abuses. Accordingly, there is a strong nexus between the ORF
and the Exchange's regulatory activities with respect to customer
trading activity of its Members.
---------------------------------------------------------------------------

    \20\ If the OCC clearing member is a GEMX member, ORF is
assessed and collected on all cleared customer contracts (after
adjustment for CMTA); and (2) if the OCC clearing member is not a
GEMX member, ORF is collected only on the cleared customer contracts
executed at GEMX, taking into account any CMTA instructions which
may result in collecting the ORF from a non-member.
    \21\ ISG is an industry organization formed in 1983 to
coordinate intermarket surveillance among the SROs by cooperatively
sharing regulatory information pursuant to a written agreement
between the parties. The goal of the ISG's information sharing is to
coordinate regulatory efforts to address potential intermarket
trading abuses and manipulations.
---------------------------------------------------------------------------

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. This proposal does not create
an unnecessary or inappropriate intra-market burden on competition
because the ORF applies to all customer activity, thereby raising
regulatory revenue to offset regulatory expenses. It also supplements
the regulatory revenue derived from non-customer activity. The Exchange
notes, however, the proposed change is not designed to address any
competitive issues. Indeed, this proposal does not create an
unnecessary or inappropriate inter-market burden on competition because
it is a regulatory fee that supports regulation in furtherance of the
purposes of the Act. The Exchange is obligated to ensure that the
amount of regulatory revenue collected from the ORF, in combination
with its other regulatory fees and fines, does not exceed regulatory
costs.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A) of the Act \22\ and paragraph (f) of Rule 19b-4 \23\
thereunder. At any time within 60 days of the filing of the proposed
rule change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission will institute proceedings to
determine whether the proposed rule change should be approved or
disapproved.
---------------------------------------------------------------------------

    \22\ 15 U.S.C. 78s(b)(3)(A).
    \23\ 17 CFR 240.19b-4(f).
---------------------------------------------------------------------------

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
File No. SR-GEMX-2022-14 on the subject line.

Paper Comments

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

All submissions should refer to File No. SR-GEMX-2022-14. 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 No. SR-GEMX-2022-14, and should be submitted on or
before January 30, 2023.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\24\
---------------------------------------------------------------------------

    \24\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Sherry R. Haywood,
Assistant Secretary.
[FR Doc. 2023-00118 Filed 1-6-23; 8:45 am]
BILLING CODE 8011-01-P


<!DOCTYPE HTML PUBLIC "-//-//W3C//DTD HTML 3.2//EN">

<META name="generator" content="WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI - Ethical Principles for Medical Research Involving Human Subjects">
<META name="creation-date" content="29/12/2009 10:18:57 ">
<TITLE>WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI - Ethical Principles for Medical Research Involving Human Subjects</TITLE>

WORLD MEDICAL ASSOCIATION DECLARATION
OF HELSINKI - Ethical Principles for Medical
Research Involving Human Subjects
Adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964, and
amended by the:
29th WMA General Assembly, Tokyo, Japan, October 1975
35th WMA General Assembly, Venice, Italy, October 1983
41st WMA General Assembly, Hong Kong, September 1989
48th WMA General Assembly, Somerset West, Republic of South Africa, October
1996
52nd WMA General Assembly, Edinburgh, Scotland, October 2000
53rd WMA General Assembly, Washington 2002 (Note of Clarification on
paragraph 29 added)
55th WMA General Assembly, Tokyo 2004 (Note of Clarification on Paragraph 30
added)
59th WMA General Assembly, Seoul, October 2008
A.
INTRODUCTION
1.
The World Medical Association (WMA) has developed the
Declaration of Helsinki as a statement of ethical principles for
medical research involving human subjects, including research on
identifiable human material and data.
The Declaration is intended to be read as a whole and each of its
constituent paragraphs should not be applied without consideration
of all other relevant paragraphs.
2.
Although the Declaration is addressed primarily to physicians, the
WMA encourages other participants in medical research involving
human subjects to adopt these principles.
3.
It is the duty of the physician to promote and safeguard the health
of patients, including those who are involved in medical research.
The physician's knowledge and conscience are dedicated to the
fulfilment of this duty.
4.
The Declaration of Geneva of the WMA binds the physician with the
words, "The health of my patient will be my first consideration," and
the International Code of Medical Ethics declares that, "A physician
shall act in the patient's best interest when providing medical care."
5.
Medical progress is based on research that ultimately must include
studies involving human subjects. Populations that are
underrepresented in medical research should be provided
appropriate access to participation in research.
6.
In medical research involving human subjects, the well-being of the
individual research subject must take precedence over all other
interests.

7.
The primary purpose of medical research involving human subjects
is to understand the causes, development and effects of diseases
and improve preventive, diagnostic and therapeutic interventions
(methods, procedures and treatments). Even the best current
interventions must be evaluated continually through research for
their safety, effectiveness, efficiency, accessibility and quality.
8.
In medical practice and in medical research, most interventions
involve risks and burdens.
9.
Medical research is subject to ethical standards that promote
respect for all human subjects and protect their health and rights.
Some research populations are particularly vulnerable and need
special protection. These include those who cannot give or refuse
consent for themselves and those who may be vulnerable to
coercion or undue influence.
10.Physicians should consider the ethical, legal and regulatory norms
and standards for research involving human subjects in their own
countries as well as applicable international norms and standards.
No national or international ethical, legal or regulatory requirement
should reduce or eliminate any of the protections for research
subjects set forth in this Declaration.
B.
BASIC PRINCIPLES FOR ALL MEDICAL RESEARCH
11. It is the duty of physicians who participate in medical research to
earch involving human subjects must conform to
gh
al
ercised in the conduct of medical
rch study involving
l.
inciples in
e
y.
protect the life, health, dignity, integrity, right to self-determination,
privacy, and confidentiality of personal information of research
subjects.
12. Medical res
generally accepted scientific principles, be based on a thorou
knowledge of the scientific literature, other relevant sources of
information, and adequate laboratory and, as appropriate, anim
experimentation. The welfare of animals used for research must be
respected.
13. Appropriate caution must be ex
research that may harm the environment.
14. The design and performance of each resea
human subjects must be clearly described in a research protoco
The protocol should contain a statement of the ethical
considerations involved and should indicate how the pr
this Declaration have been addressed. The protocol should includ
information regarding funding, sponsors, institutional affiliations,
other potential conflicts of interest, incentives for subjects and
provisions for treating and/or compensating subjects who are
harmed as a consequence of participation in the research stud
The protocol should describe arrangements for post-study access
by study subjects to interventions identified as beneficial in the
study or access to other appropriate care or benefits.

15.The research protocol must be submitted for consideration,
comment, guidance and approval to a research ethics committee
before the study begins. This committee must be independent of
the researcher, the sponsor and any other undue influence. It must
take into consideration the laws and regulations of the country or
countries in which the research is to be performed as well as
applicable international norms and standards but these must not be
allowed to reduce or eliminate any of the protections for research
subjects set forth in this Declaration. The committee must have the
right to monitor ongoing studies. The researcher must provide
monitoring information to the committee, especially information
about any serious adverse events. No change to the protocol may
be made without consideration and approval by the committee.
16.Medical research involving human subjects must be conducted only
by individuals with the appropriate scientific training and
qualifications. Research on patients or healthy volunteers requires
the supervision of a competent and appropriately qualified
physician or other health care professional. The responsibility for
the protection of research subjects must always rest with the
physician or other health care professional and never the research
subjects, even though they have given consent.
17.Medical research involving a disadvantaged or vulnerable
population or community is only justified if the research is
responsive to the health needs and priorities of this population or
community and if there is a reasonable likelihood that this
population or community stands to benefit from the results of the
research.
18.Every medical research study involving human subjects must be
preceded by careful assessment of predictable risks and burdens to
the individuals and communities involved in the research in
comparison with foreseeable benefits to them and to other
individuals or communities affected by the condition under
investigation.
19.Every clinical trial must be registered in a publicly accessible
database before recruitment of the first subject.
20.Physicians may not participate in a research study involving human
subjects unless they are confident that the risks involved have been
adequately assessed and can be satisfactorily managed.
Physicians must immediately stop a study when the risks are found
to outweigh the potential benefits or when there is conclusive proof
of positive and beneficial results.
21.Medical research involving human subjects may only be conducted
if the importance of the objective outweighs the inherent risks and
burdens to the research subjects.
22.Participation by competent individuals as subjects in medical
research must be voluntary. Although it may be appropriate to

consult family members or community leaders, no competent
individual may be enrolled in a research study unless he or she
freely agrees.
23.Every precaution must be taken to protect the privacy of research
subjects and the confidentiality of their personal information and to
minimize the impact of the study on their physical, mental and
social integrity.
24.In medical research involving competent human subjects, each
potential subject must be adequately informed of the aims,
methods, sources of funding, any possible conflicts of interest,
institutional affiliations of the researcher, the anticipated benefits
and potential risks of the study and the discomfort it may entail, and
any other relevant aspects of the study. The potential subject must
be informed of the right to refuse to participate in the study or to
withdraw consent to participate at any time without reprisal. Special
attention should be given to the specific information needs of
individual potential subjects as well as to the methods used to
deliver the information. After ensuring that the potential subject has
understood the information, the physician or another appropriately
qualified individual must then seek the potential subject's freely-
given informed consent, preferably in writing. If the consent cannot
be expressed in writing, the non-written consent must be formally
documented and witnessed.
25.For medical research using identifiable human material or data,
physicians must normally seek consent for the collection, analysis,
storage and/or reuse. There may be situations where consent
would be impossible or impractical to obtain for such research or
would pose a threat to the validity of the research. In such
situations the research may be done only after consideration and
approval of a research ethics committee.
26.When seeking informed consent for participation in a research
study the physician should be particularly cautious if the potential
subject is in a dependent relationship with the physician or may
consent under duress. In such situations the informed consent
should be sought by an appropriately qualified individual who is
completely independent of this relationship.
27.For a potential research subject who is incompetent, the physician
must seek informed consent from the legally authorized
representative. These individuals must not be included in a
research study that has no likelihood of benefit for them unless it is
intended to promote the health of the population represented by the
potential subject, the research cannot instead be performed with
competent persons, and the research entails only minimal risk and
minimal burden.
28.When a potential research subject who is deemed incompetent is
able to give assent to decisions about participation in research, the

physician must seek that assent in addition to the consent of the
legally authorized representative. The potential subject's dissent
should be respected.
29.Research involving subjects who are physically or mentally
incapable of giving consent, for example, unconscious patients,
may be done only if the physical or mental condition that prevents
giving informed consent is a necessary characteristic of the
research population. In such circumstances the physician should
seek informed consent from the legally authorized representative. If
no such representative is available and if the research cannot be
delayed, the study may proceed without informed consent provided
that the specific reasons for involving subjects with a condition that
renders them unable to give informed consent have been stated in
the research protocol and the study has been approved by a
research ethics committee. Consent to remain in the research
should be obtained as soon as possible from the subject or a
legally authorized representative.
30.Authors, editors and publishers all have ethical obligations with
regard to the publication of the results of research. Authors have a
duty to make publicly available the results of their research on
human subjects and are accountable for the completeness and
accuracy of their reports. They should adhere to accepted
guidelines for ethical reporting. Negative and inconclusive as well
as positive results should be published or otherwise made publicly
available. Sources of funding, institutional affiliations and conflicts
of interest should be declared in the publication. Reports of
research not in accordance with the principles of this Declaration
should not be accepted for publication.
C.
ADDITIONAL PRINCIPLES FOR MEDICAL RESEARCH COMBINED
WITH MEDICAL CARE
31. The physician may combine medical research with medical care
has
urdens and effectiveness of a new intervention
able in studies
ecessary to
only to the extent that the research is justified by its potential
preventive, diagnostic or therapeutic value and if the physician
good reason to believe that participation in the research study will
not adversely affect the health of the patients who serve as
research subjects.
32. The benefits, risks, b
must be tested against those of the best current proven
intervention, except in the following circumstances:
ƒ
The use of placebo, or no treatment, is accept
where no current proven intervention exists; or
ƒ
Where for compelling and scientifically sound
methodological reasons the use of placebo is n
determine the efficacy or safety of an intervention and the
patients who receive placebo or no treatment will not be

subject to any risk of serious or irreversible harm. Extreme
care must be taken to avoid abuse of this option.
33. At the conclusion of the study, patients entered into the study are
e
ian must fully inform the patient which aspects of the
m the
t
n if in
, this
22.10.2008
entitled to be informed about the outcome of the study and to shar
any benefits that result from it, for example, access to interventions
identified as beneficial in the study or to other appropriate care or
benefits.
34. The physic
care are related to the research. The refusal of a patient to
participate in a study or the patient's decision to withdraw fro
study must never interfere with the patient-physician relationship.
35. In the treatment of a patient, where proven interventions do not
exist or have been ineffective, the physician, after seeking exper
advice, with informed consent from the patient or a legally
authorized representative, may use an unproven interventio
the physician's judgement it offers hope of saving life, re-
establishing health or alleviating suffering. Where possible
intervention should be made the object of research, designed to
evaluate its safety and efficacy. In all cases, new information
should be recorded and, where appropriate, made publicly
available.