Page 1 of 5 DRAFT February 22, 2005 FIFRA SCIENTIFIC ADVISORY PANEL ( SAP) OPEN MEETING MARCH 1 2, 2005 FIFRA SAP WEB SITE http:// www. epa. gov/ scipoly/ sap/ OPP Docket Telephone: ( 703) 305 5805 Docket Number: OPP 2004 0395 SCIENTIFIC ISSUES ASSOCIATED WITH THE HUMAN HEALTH ASSESSMENT OF THE CRY 34Ab1 PROTEIN TUESDAY, MARCH 1, 2005 Holiday Inn  National Airport 2650 Jefferson Davis Highway Arlington, VA 22202 Telephone: ( 703) 684 7200

8: 30 AM Introduction and Identification of Panel Members   Stephen Roberts, PhD. ( FIFRA SAP Session Chair)

8: 45 AM Administrative Procedures by Designated Federal Official   Paul Lewis, PhD.

8: 50 AM Welcome   Clifford Gabriel, PhD. ( Director, Office of Science Coordination and Policy, EPA)

8: 55 AM Opening Remarks   Janet Andersen, PhD. ( Director, Biopesticides and Pollution Prevention Division, Office of Pesticide Programs, EPA)

9: 00 AM Scientific Issues Associated with the Human Health Assessment of the Cry34Ab1 Protein   Rebecca Edelstein, PhD. ( Office of Pesticide Programs, EPA)

10: 15 AM BREAK

10: 30 AM Public Comments

12: 30 PM LUNCH

1: 30 PM Panel Discussion Protocols for Digestibility Assays 1) Dow has stated that enzyme kinetic theory predicts first order kinetics for pepsin hydrolysis under conditions of high enzyme and low substrate concentrations and has demonstrated that the rate of substrate disappearance under these conditions follows firstorder kinetics for a number of proteins. However, for several proteins, initial time points were omitted to achieve a good fit to the model. Dow states that the data were not Page 2 of 5 included " based on theoretical considerations, which include: potential zero order or mixed order kinetics due to high substrate concentration, possible presence of denatured and highly digestible protein contaminating the native protein preparation, or the possibility of an initial burst phase or transient phase preceding the first order phase of digestion ( Schnell and Maini, 2000; Milgrom et al., 1998)."

The Panel is requested to comment on whether the explanation justifies omitting early time points or whether the poor fit of early time points indicates a problem with the model.

2) Dow has asserted that first order decay is predicted based on enzyme theory as long as the pepsin concentration is high and the substrate concentration is low (<< Km) and that the first order rate constant determined under these conditions is equal to Vmax/ Km. Dow has also stated that as long as first order conditions are met, first order rate constants and half lives are unaffected by changes in substrate protein concentration and that first order rate constants can be used to predict relative digestion efficiencies for proteins even if the protein concentration is varied among experiments. In addition, Dow has stated that at the USP concentration for pepsin of 0.32%, the enzyme concentration is saturating and can also be varied between experiments without affecting the first order rate constant.

The Panel is asked to comment on these statements. How much can the pepsin or protein substrate concentrations vary without affecting the kinetics of pepsin digestion and firstorder rate constants?

3: 00 PM BREAK

3: 15 PM Panel Discussion ( continued)

3) Typically, for comparing the in vitro digestibility of different proteins, researchers have used fixed concentrations of pepsin and substrate protein on a weight basis ( mg/ mL) rather than adjusting for molecular weight of the substrate protein, presumably because larger proteins likely have more potential pepsin cleavage sites. However, Dow states that " while multiple pepsin labile sites may occur within a protein, a single site is often responsible for limiting digestion rates, and thus the number of molecules, rather than total weight, is most often more influential in determining the kinetics that describe decay."

The Panel is asked to comment on Dow's statement. To compare the rate of pepsin digestion of different proteins, is it more appropriate for the concentration of test protein to be constant on a weight basis ( mg/ mL) or a mole basis ( mol/ L)?

4) Typically, researchers have looked at the effect of pepsin to substrate ratio rather than concentrations on digestion ( Karamac, et al., 2002). How do varying the ratios and/ or concentrations affect the rate of hydrolysis?

4: 30 PM ADJOURNMENT Page 3 of 5 FIFRA SCIENTIFIC ADVISORY PANEL ( SAP) OPEN MEETING MARCH 1 2, 2005 FIFRA SAP WEB SITE http:// www. epa. gov/ scipoly/ sap/ OPP Docket Telephone: ( 703) 305 5805 Docket Number: OPP 2004 0395 SCIENTIFIC ISSUES ASSOCIATED WITH THE HUMAN HEALTH ASSESSMENT OF THE CRY 34Ab1 PROTEIN WEDNESDAY, MARCH 2, 2005 Holiday Inn  National Airport 2650 Jefferson Davis Highway Arlington, VA 22202 Telephone: ( 703) 684 7200

8: 30 AM Introduction and Identification of Panel Members   Stephen Roberts, Ph. D. ( FIFRA SAP Session Chair)

8: 35 AM Administrative procedures by Designated Federal Official   Paul Lewis, PhD.

8: 40 AM Follow up from Previous Day's Discussion   Rebecca Edelstein, PhD. ( Office of Pesticide Programs, EPA)

9: 00 AM Panel Discussion ( continued)

5) Different assays exist for determining pepsin activity. A pepsin activity assay based on measuring the trichloracetic acid soluble products of pepsin hydrolysis of hemoglobin is provided in USP, 2004 under the entry for pepsin. However, the entry in USP, 2004 for " gastric fluid, simulated" references the Food Chemicals Codex for pepsin activity, which provides an assay that measures pepsin digestion of egg albumen.

The Panel is asked to comment on the appropriateness of using a fixed concentration of pepsin versus using a fixed specific activity of pepsin in digestibility protocols. How would the use of different pepsin activity assays affect the measured pepsin activity units?

6) Typically, scientists have used SDS PAGE with staining or western blot analysis for monitoring digestion reactions. HPLC is also sometimes used.

The Panel is asked to comment on the pros and cons of the different methods that could be used for monitoring digestion reactions.

10: 30 AM BREAK

12: 00 PM LUNCH

1: 00 PM Panel Discussion ( continued) Page 4 of 5 7) Some researchers have used one digestion reaction and removed aliquots at various times for monitoring, while others have set up separate reactions for each of the time points.

What are the pros and cons of these approaches?

8) Under the current protocol, Dow's kinetic approach is only applicable to moderately digestible proteins ( i. e., using Dow's protocol, many proteins digest too quickly and some too slowly to obtain an adequate number of data points for quantitative kinetic analysis).

Please comment on the usefulness of the kinetic approach for proteins that are not rapidly degraded.

3: 00 AM BREAK

3: 15 PM Panel Discussion ( continued)

Allergenicity Assessment 9) The 2001 FAO/ WHO report and 2003 Codex guidelines both recommend using in vitro digestibility in assessing the allergenicity potential of a protein. The FAO/ WHO report provides a " decision tree" approach, while the Codex guidelines suggest a weight of evidence approach. Codex guidelines state " resistance of a protein to degradation in the presence of pepsin under appropriate conditions indicates that further analysis should be conducted to determine the likelihood of the newly expressed protein being allergenic," and " it should be taken into account that a lack of resistance to pepsin does not exclude that the newly expressed protein can be a relevant allergen." The Codex guidelines, however, don't specify how a protein should be further evaluated if it is " resistant" to degradation, and " resistant" is not defined.

a) What weight should in vitro digestibility studies be given in the overall assessment compared with other criteria such as sequence homology?

b) The Panel is asked to comment on the appropriateness of setting acceptable/ unacceptable limits for digestibility in assessing the safety of a protein.

10) Stable digestion fragments are often formed during pepsin digestion of proteins, and Dow has used the kinetic approach to estimate the half lives of several digestion fragments.

Please comment on the significance of the rate of digestion of protein fragments for allergenicity assessments.

Cry34Ab1 and Cry35Ab1 Assessment 11) Cry34Ab1 appears to be moderately digested in SGF, rather than rapidly digested. Considering all of the available information   Cry34Ab1 originates from a non allergenic Page 5 of 5 source, has no sequence similarity with known allergens, is not glycoslyated, is inactivated by heat, is moderately digested in SGF, and will only be present at low levels in food   EPA has concluded that Cry34Ab1 is unlikely to be a food allergen.

Please comment on the Agency's conclusions regarding the allergenicity of Cry34Ab1.

5: 00 PM ADJOURNMENT Please be advised that agenda times are approximate. For further information, please contact the Designated Federal Official for this meeting, Paul Lewis via telephone: ( 202) 564 8450; fax: ( 202) 564 8382; or email: lewis. paul@ epa. gov


[Federal Register Volume 88, Number 114 (Wednesday, June 14, 2023)]
[Notices]
[Pages 38862-38864]
[FR Doc No: 2023-12684]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OLEM-2023-0228, FRL-10820-02-OLEM]

Draft National Strategy To Prevent Plastic Pollution: Extension
of Comment Period

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of availability; extension of comment period.

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SUMMARY: The Environmental Protection Agency (EPA) is extending the
comment period for the Draft National Strategy to Prevent Plastic
Pollution, which can be found at https://www.epa.gov/circulareconomy/draft-national-strategy-prevent-plastic-pollution. The EPA published
the Notice of Availability in the Federal Register on May 2, 2023, and
the public comment period was scheduled to end on June 16, 2023.
However, the EPA has received several requests for additional time to
develop and submit comments. In response to the request for additional
time, the EPA is extending the comment period for an additional 45 days
through July 31, 2023.

DATES: The comment period for the Draft National Strategy to Prevent
Plastic Pollution published on May 2, 2023 at 88 FR 27502, is extended.
Comments must be received on or before July 31, 2023.

ADDRESSES: To review the Draft National Strategy to Prevent Plastic
Pollution, please visit https://www.epa.gov/circulareconomy/draft-national-strategy-prevent-plastic-pollution. Submit your comments,
referencing Docket ID No. EPA-HQ-OLEM-2023-0228. Comments submitted in
response to this notice may be submitted through the following:
     Federal eRulemaking Portal: Go to https://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. 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: https://www.epa.gov/dockets/commenting-epa-dockets.
    Instructions: All submissions received must include the Docket ID
No. OLEM-2023-0228 for this notice. Comments received may be posted
without change to https://www.regulations.gov/, including any personal
information provided. For detailed instructions on sending comments and
additional information on the Request for Information process, see the
``Public Participation'' heading of the SUPPLEMENTARY INFORMATION
section of this document.

FOR FURTHER INFORMATION CONTACT: For questions concerning this
document, contact Tameka Taylor at<PHONE_NUMBER>, Resource Conservation
and Sustainability Division, Office of Resource Conservation and
Recovery, Office of Land and Emergency Management, Mail Code 5306T,
Environmental Protection Agency, 1200 Pennsylvania Avenue NW,
Washington, DC 20004; Email: [email protected]. For more
information on this strategy and others developed as part of EPA's
Series on Building a Circular Economy for All, please visit https://www.epa.gov/circular-economy.

SUPPLEMENTARY INFORMATION:

I. Public Participation

    Response to this request for public comment is voluntary. Submit
your comments, identified by Docket ID No. EPA-HQ-OLEM-2023-0228, at
https://www.regulations.gov/ (our preferred method), or the other
methods identified in the ADDRESSES section. Once submitted, comments
cannot be edited or removed from the docket. The EPA may publish any
comment received to its public docket. Responses to this request for
public comment may be submitted by a single party or a team. Responses
will only be accepted using Microsoft Word (.docx) or Adobe PDF (.pdf)
file formats. The response document should contain the following:
     Two clearly delineated sections: (1) Cover page with
company name and contact information; and (2) responses by topic and/or
that address specific EPA questions.
     1-inch margins (top, bottom, and sides).
     Times New Roman and 12-point font.

    Comments containing references, studies, research, and other
empirical data that are not widely published should include copies or
electronic links to the referenced materials. Do not submit to EPA's
docket at https://www.regulations.gov/ any information you consider to
be Confidential Business Information (CBI), Proprietary Business
Information (PBI), 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. The 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). Please visit: https://www.epa.gov/dockets/commenting-epa-dockets for additional submission
methods; the full EPA public comment policy; information about CBI,
PBI, or multimedia submissions; and general guidance on making
effective comments. No confidential and/or business proprietary
information, copyrighted information, or personally identifiable
information should be submitted in response to this notice.
    Privacy Note: All comments received from members of the public will
be available for public viewing on Regulations.gov. In accordance with
FAR 15.202(3), responses to this notice are not offers and cannot be
accepted by the Federal Government to form a binding contract.
Additionally, those submitting responses are solely responsible for all
expenses associated with response preparation.

II. General Information

A. What is the purpose of this request for public comment?

    Section 301 of the Save our Seas 2.0 Act charges EPA, in
consultation with stakeholders, with developing a strategy to improve
post-consumer materials management and infrastructure to reduce plastic
waste and other post-consumer materials in waterways and oceans. The
Draft National Strategy to Prevent Plastic Pollution, satisfies
Congress' direction to EPA in section 301 of the Save Our Seas 2.0 Act
to develop a strategy to improve post-consumer materials management and
infrastructure for the purpose of reducing plastic waste and other
post-consumer materials in waterways and oceans. EPA's National
Recycling Strategy was published in November 2021 and primarily focuses
on enhancing and advancing the national municipal solid waste recycling
system, including plastic products in municipal solid waste. This
strategy, the Draft National Strategy to Prevent Plastic Pollution,
builds upon the National Recycling Strategy by focusing on actions to
reduce, reuse, collect, and capture plastic waste.
    The Draft National Strategy to Prevent Plastic Pollution, provides
voluntary actions that can be implemented in the United States aimed at
eliminating the release of plastic waste from land-based sources into
the environment by 2040. This is a domestic strategy that identifies
strategic objectives and voluntary actions where EPA can work
collaboratively with U.S. stakeholders to prevent plastic pollution and
reduce, reuse, collect, and capture plastic and other waste from land-
based sources. The proposed actions under each objective create
opportunities to shift from a linear approach in plastic materials
management to a more circular system that is restorative or
regenerative by design, enables resources to maintain their highest
value for as long as possible, and aims for the elimination of waste.
Sea-based sources are not in the scope of this strategy.
    With input from stakeholders, EPA has identified three draft
objectives for the strategy: (A) Reduce Pollution During Plastic
Production; (B) Improve post-use materials management; and (C) Prevent
trash and microplastics from entering waterways and remove escaped
trash from the environment. The proposed actions under each objective
support the United States' shift to a circular approach that is
restorative or regenerative by design, enables resources to maintain
their highest value for as long as possible, and aims to eliminate
waste in the management of plastic products. EPA is seeking information
about the objectives and voluntary actions identified in this draft
strategy. Public comments will inform the Agency's efforts to finalize
the strategy and further work with stakeholders to implement actions to
reduce plastic waste and other post-consumer materials in waterways and
oceans. This Notice follows in sequence, a previous public comment
period for the EPA's National Recycling Strategy, which collectively
satisfies the charge given to EPA by Congress under the SOS 2.0 Act.

III. Request for Information

    In November 2021, EPA held multiple stakeholder feedback sessions
with Federal agencies, states, territories, tribes, industry, and non-
profit organizations to inform the development of this strategy.
Between November 2021 and July 2022, EPA hosted virtual meetings across
the country with interested stakeholders to inform the development of
new grant programs established by the Infrastructure Investment and
Jobs Act, which further informed the development of this strategy. This
Notice and any future notices aim to supplement stakeholder engagement
sessions and, provide all interested individuals and organizations with
the opportunity to offer valuable input on the voluntary actions
identified in this strategy. In addition to receiving general feedback
on the draft strategy, EPA is interested in receiving feedback on the
following:
     Which actions are the most important and would have the
greatest positive impact at the local, regional, national, and global
level?
    [cir] Which actions can best protect human health and environmental
quality?
    [cir] Which actions are most important to address environmental
justice and climate change?
    [cir] What are the key steps and milestones necessary to
successfully implement the actions in the draft strategy?
     What are the most important roles and/or actions for
Federal agencies to lead?
     Is your organization willing to lead an action or
collaborate with others to implement actions?
    [cir] What factors would your organization consider when
determining whether to lead an action?
     What are potential unintended consequences of the proposed
actions that could impact communities considered overburdened or
vulnerable, such as shifts in production or management methods?
     What are the key metrics and indicators that EPA should
use to measure progress in reducing plastic and other waste in
waterways and oceans?
     What criteria should processes other than mechanical
recycling meet to be considered ``recycling activities'' (e.g.,
``plastics-to-plastics outputs are `recycling' if the output is a
product that could again be recycled into another product or to extent
that it can achieve viable feedstock for new plastic materials'')? How
should health and environmental impacts be considered in these
criteria?
     Are there other actions that should be included in this
strategy?

    [cir] Should EPA expand the scope of the strategy to include sea-
based sources?
    [cir] Should specific types of plastic products be targeted for
reduction or reuse in this strategy?
     Do you have any additional information or recommendations
for EPA regarding these or other proposed actions in this draft
strategy?

IV. Disclaimer and Important Note

    This request for public comment is issued solely for information,
research and planning purposes and does not constitute a Request for
Proposals (RFP) or a Request for Applications (RFA). Responding to this
notice will not give any advantage to or preclude any organization or
individual in any subsequently issued solicitation, RFP, or RFA. Any
future development activities related to this activity will be
announced separately. This notice does not represent any award
commitment on the part of the U.S. Government, nor does it obligate the
Government to pay for costs incurred in the preparation and submission
of any responses.

    Dated: June 8, 2023.
Carolyn Hoskinson,
Director, Office of Resource Conservation and Recovery.
[FR Doc. 2023-12684 Filed 6-13-23; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: October 6, 2008 (Volume 73, Number 194)]
[Proposed Rules]
[Page 58084]
[DOCID:fr06oc08-19]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R04-OAR-2005-0534; FRL-8725-3]

Approval and Promulgation of Implementation Plans North Carolina:
Prevention of Significant Deterioration and Nonattainment New Source
Review Rules; Extension of Comment Period

AGENCY: Environmental Protection Agency (EPA).

ACTION: Extension of public comment period.

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SUMMARY: EPA is extending the comment period for a proposed rule
published September 9, 2008 (73 FR 52226). On September 9, 2008, EPA
proposed to approve revisions to the North Carolina State
Implementation Plan (SIP) submitted by the State of North Carolina in
three submittals dated November 30, 2005, March 16, 2007, and June 20,
2008. The proposed revisions modify North Carolina's Prevention of
Significant Deterioration and Nonattainment New Source Review
permitting regulations in the SIP to address changes to the federal New
Source Review (NSR) regulations, which were promulgated by EPA on
December 31, 2002, and reconsidered with minor changes on November 7,
2003 (collectively, these two final actions are referred to as the
``2002 NSR Reform Rules''). In addition, the proposed revisions address
an update to the NSR regulations promulgated by EPA on November 29,
2005 (``Ozone Implementation NSR update'') relating to the
implementation of the 1997 8-hour ozone National Ambient Air Quality
Standards (NAAQS). At the request of several commentors, EPA is
extending the comment period through November 10, 2008.

DATES: Written comments must be received on or before November 10,
2008.

ADDRESSES: Comments should be submitted to: Ms. Yolanda Adams, Air
Permits Section, Air Planning Branch, Air, Pesticides and Toxics
Management Division, U.S. Environmental Protection Agency, Region 4, 61
Forsyth Street, SW., Atlanta, Georgia 30303-8960. Telephone number:
(404) 562-9214; e-mail address<EMAIL_ADDRESS>Additional
instructions to comment can be found in the notice of proposed
rulemaking published September 9, 2008 (73 FR 52226).

FOR FURTHER INFORMATION CONTACT: For information regarding the North
Carolina State Implementation Plan, contact Ms. Nacosta Ward,
Regulatory Development Section, Air Planning Branch, Air, Pesticides
and Toxics Management Division, U.S. Environmental Protection Agency,
Region 4, 61 Forsyth Street, SW., Atlanta, Georgia 30303-8960.
Telephone number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
For information regarding New Source Review, contact Ms. Yolanda Adams,
Air Permits Section, at the same address above. Telephone number: (404)
562-9214; e-mail address<EMAIL_ADDRESS>
    Dated: September 26, 2008.
J. I. Palmer, Jr.,
Regional Administrator, Region 4.
 [FR Doc. E8-23553 Filed 10-3-08; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 87, Number 197 (Thursday, October 13, 2022)]
[Rules and Regulations]
[Pages 62034-62037]
[FR Doc No: 2022-21972]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R4-OAR-2022-0226; FRL-10161-02-R4]

Air Plan Approval; South Carolina; Revisions to Startup,
Shutdown, and Malfunction Rules

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is approving a State
Implementation Plan (SIP) revision submitted by the State of South
Carolina, through the South Carolina Department of Health and
Environmental Control (SC DHEC), on November 4, 2016. This revision was
submitted by South Carolina in response to a finding of substantial
inadequacy and SIP call published by EPA on June 12, 2015, of
provisions in the South Carolina SIP related to excess emissions during
startup, shutdown, and malfunction (SSM) events. EPA is approving the
SIP revision and finds that the revision corrects the deficiencies
identified in the June 12, 2015, SIP call. EPA is also approving
portions of multiple SIP revisions previously submitted by SC DHEC on
October 1, 2007, July 18, 2011, August 8, 2014, and August 12, 2015, as
they relate to the provisions identified in the June 12, 2015, SIP
call.

DATES: This rule is effective November 14, 2022.

ADDRESSES: EPA has established a docket for these actions under Docket
Identification No. EPA-R4-OAR-2022-0226. All documents in the docket
are listed on the www.regulations.gov website. Although listed in the
index, some information may not be publicly available, i.e.,
Confidential Business Information or other information whose disclosure
is restricted by statute. Certain other material, such as copyrighted
material, is not placed on the internet and will be publicly

available only in hard copy form. Publicly available docket materials
are available either electronically through www.regulations.gov or in
hard copy at the 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. EPA requests that if at all possible, you contact the
person listed in the FOR FURTHER INFORMATION CONTACT section to
schedule your inspection. The Regional Office's official hours of
business are Monday through Friday 8:30 a.m. to 4:30 p.m., excluding
Federal holidays.

FOR FURTHER INFORMATION CONTACT: Estelle Bae, Air Permits 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. Ms. Bae can be reached by telephone at
(404) 562-9143 or via electronic mail at [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    On August 23, 2022, EPA proposed to approve portions of multiple
SIP revisions submitted by SC DHEC on October 1, 2007, July 18, 2011,
August 8, 2014, August 12, 2015, and November 17, 2016. See 87 FR
51631. In that notice of proposed rulemaking (NPRM), EPA also proposed
to determine that the SIP revision corrects the deficiencies with
respect to the South Carolina SIP that the Agency identified in the
June 12, 2015, action entitled ``State Implementation Plans: Response
to Petition for Rulemaking; Restatement and Update of EPA's SSM Policy
Applicable to SIPs; Findings of Substantial Inadequacy; and SIP Calls
to Amend Provisions Applying to Excess Emissions During Periods of
Startup, Shutdown, and Malfunction'' (``2015 SSM SIP Action''). See 80
FR 33839 (June 12, 2015). The reasons for the proposed approval and
determination are stated in the August 23, 2022, NPRM (see 87 FR 51631)
and will not be restated here. The public comment period for EPA's
proposed approval and determination ended on September 22, 2022. EPA
received one set of comments in a joint letter submitted by the Sierra
Club and the Environmental Integrity Project (hereinafter collectively
referred to as the commenter) on September 20, 2022. These comments are
available in the docket for these actions.

II. Response to Comments

    The commenter provided comments both in support of and adverse to
EPA's proposed actions. EPA will not address the comments that express
support for the proposed actions. Instead, this section of the final
rulemaking notice will focus on the portion of the September 20, 2022,
letter that did not support the proposed actions.
    Comment: The commenter states that EPA should disapprove or
conditionally approve the revision to South Carolina's visible
emissions rule at Regulation 61-62.5, Standard No. 1, Section I.C \1\
that adds an exemption for ``natural gas and propane fired units'' from
the requirement that the owner or operator maintain a startup and
shutdown log. The commenter alleges that burning these two fuels has
the potential to emit elevated levels of particulate matter (PM),
sulfur oxides (SOX), nitrogen oxides (NOX), and
other pollutants that may contribute to opacity during SSM events and
that adequate recordkeeping requirements during startup and shutdown
periods are essential for determining compliance with the Clean Air Act
(CAA or Act). According to the commenter, excluding these fuel-burning
sources from the recordkeeping requirement undermines the applicable
emission limits in the South Carolina SIP and ``frustrates'' federal
CAA enforcement.
---------------------------------------------------------------------------

    \1\ Section I.C. regulates visible emissions from fuel burning
operations, setting opacity limits from twenty to sixty percent,
depending on the age of the source and whether emissions are caused
by soot blowing.
---------------------------------------------------------------------------

    Response: EPA disagrees that the Agency should disapprove or
conditionally approve the addition of an exemption from the requirement
to keep logs of startups and shutdowns for fuel burning units that fire
only natural gas and propane in Regulation 61-62.5, Standard No. 1,
Section I.C. The existing SIP-approved text of Section I.C states:

    The opacity standards set forth above do not apply during
startup or shutdown. Owners and operators shall, to the extent
practicable, maintain and operate any source including associated
air pollution control equipment in a manner consistent with good air
pollution control practices for minimizing emissions. In addition,
the owner or operator shall maintain a log of the time, magnitude,
duration and any other pertinent information to determine periods of
startup and shutdown and make available to the Department upon
request.

    In the NPRM, EPA proposed to approve two revisions to this text.
The first revision, state-effective in 2016, directly addresses the
2015 SSM SIP Action by removing the first sentence of the paragraph,
which provides an exemption from opacity standards during startup or
shutdown. This change satisfies EPA's June 12, 2015, SIP call for South
Carolina regarding Section I.
    The second revision, state-effective in 2011 and 2015,\2\ inserts
the phrase ``of fuel burning sources except natural gas and propane
fired units'' following the word ``operator'' into the third sentence
of the text. The effect of this change was to specify that the
requirement to maintain a startup and shutdown log applies to fuel
burning sources but does not apply to units that fire natural gas or
propane.\3\
---------------------------------------------------------------------------

    \2\ The July 18, 2011, submittal revised subparagraph C of
Section I, ``Visible Emissions,'' by excluding natural gas fired
units from the requirement to maintain a log to determine periods of
startup and shutdown. The August 12, 2015, submittal further revised
the subparagraph adding propane fired units to the log keeping
exception.
    \3\ As noted in the NPRM, EPA included this revision in an
August 16, 2017, direct final rulemaking notice. However, due to the
receipt of an adverse comment, EPA withdrew the direct final rule,
and thus, the revision remained pending. See 82 FR 47640 (October
13, 2017).
---------------------------------------------------------------------------

    The purpose of the startup and shutdown recordkeeping requirement
in Section I.C was to identify those periods when fuel burning sources
were exempt from opacity standards by requiring sources to log when
startup and shutdown events took place. However, because EPA is
removing that exemption from the SIP through this final rulemaking, the
opacity limits of Regulation 61-62.5, Standard No. 1 now apply at all
times. Consequently, the rule does not differentiate periods of startup
and shutdown from other modes of operation as related to compliance
with the opacity limits, and therefore a requirement to keep startup
and shutdown logs is no longer needed for determining compliance for
any sources, including those that burn fuels other than natural gas or
propane. Nevertheless, the State has not removed the requirement for
operations that burn fuels other than natural gas or propane to
maintain startup and shutdown logs.
    Additionally, the revision to Regulation 61-62.5, Standard No. 1,
Section I.C. being approved does not affect any excess emission
recordkeeping or reporting requirements under the SIP. For example,
facilities are generally required to obtain operating permits pursuant
to South Carolina's Regulation 61-62.1, ``Definitions and General
Requirements,'' at Section II, ``Permit Requirements.'' Section II.C.3
of this regulation requires sources that are not required to have
continuous emission monitoring systems (CEMS) to report to the State,
emissions due to equipment

failures that are greater than those described for normal operation in
the permit application and that last for one hour or more. The initial
report must be made within 24 hours of the beginning of the occurrence
of such emissions and a follow up written report must be made within 30
days. The written report covers, among other things, the magnitude of
the excess emissions, the time and duration of the excess emissions,
and the nature and cause of the excess emissions. For sources that are
required to operate CEMS, Section II.C.4 requires regular ``reports as
specified in applicable parts of'' the State's regulations. Also,
Regulation 61-62.5, Standard No. 1, Section IV, ``Opacity Monitoring
Requirements,'' requires semiannual compliance reporting for sources
required to install and operate continuous opacity monitoring systems
(COMS).\4\ This report would require the disclosure of all instances in
which the opacity provisions of Section I of Standard No. 1 have been
exceeded and include an account of the nature and cause of the excess
visible emissions.
---------------------------------------------------------------------------

    \4\ Sources that fire only gaseous fuel would be exempt from the
COMS requirements and instead would be subject to the excess
emissions reporting established via permitting at Regulation 61-
62.1, Section II.C.
---------------------------------------------------------------------------

    The Agency acknowledges the commenter's concern that burning
natural gas and propane emits pollutants that have the potential to
contribute to visible emissions. However, visible emissions concerns
from the burning of natural gas and propane are minor relative to other
available fuels. Firing these two fuels is typically associated with
few monitoring requirements, if any. See, e.g., 40 CFR part 63, subpart
DDDDD, 40 CFR part 60, subpart Da, and 40 CFR part 75. Notwithstanding
this fact, excess emissions are required to be reported in the manner
just described. For the reasons stated above and in the NPRM, EPA is
finalizing its approval of this change to 61-62.5, Standard No. 1,
Section I.C.

III. Incorporation by Reference

    In this document, EPA is finalizing regulatory text that includes
incorporation by reference. In accordance with the requirements of 1
CFR 51.5, and as discussed in Section I of this preamble, EPA is
finalizing the incorporation by reference into the South Carolina SIP
of Regulation 61-62.1, Section II.L, ``Emergency Provisions,'' which
regulates permit requirements to document emergencies, State effective
on September 23, 2016; \5\ Regulation 61-62.5, Standard No. 1, Section
I, ``Visible Emissions,'' which regulates visible emissions from fuel
burning operations, State effective on September 23, 2016; and
Regulation 61-62.5, Standard No. 4, Section XI, ``Total Reduced Sulfur
(TRS) Emissions of Kraft Pulp Mills,'' which regulates emissions of
total reduced sulfur at Kraft pulp mills, State effective on September
23, 2016. EPA has made, and will continue to make, these materials
generally available through https://www.regulations.gov and at the EPA
Region 4 Office (please contact the person identified in the For
Further Information Contact section of this preamble for more
information). Therefore, these materials have been approved by EPA for
inclusion in the SIP, have been incorporated by reference by EPA into
that plan, are fully federally enforceable under sections 110 and 113
of the CAA as of the effective date of the final rulemaking of EPA's
approval, and will be incorporated by reference in the next update to
the SIP compilation.\6\
---------------------------------------------------------------------------

    \5\ The remaining portions of Regulation 61-62.1, Section II,
retain the June 24, 2005, State effective date, as currently
approved in the South Carolina SIP under 40 CFR 52.2120(c).
Additionally, although Section II.G of Regulation 61-62.1 retains
the June 24, 2005, State effective date, paragraph G.6 specifically
is being removed from the South Carolina SIP because it is being
recodified as Section II.L of Regulation 61-62.1. These changes are
explained in more detail in Section II.A of the August 23, 2022,
NPRM.
    \6\ See 62 FR 27968 (May 22, 1997).
---------------------------------------------------------------------------

III. Final Actions

    EPA is approving South Carolina's November 4, 2016, SIP submission
with respect to Regulation 61-62.1, Section II.L; Regulation 61-62.5,
Standard No. 1, Section I.C; and Regulation 61-62.5, Standard No. 4,
Section XI.D.4. EPA is also approving portions of the October 1, 2007,
July 18, 2011, August 8, 2014, and August 12, 2015, South Carolina SIP
submissions that seek revisions to these provisions, as specified in
Section II of the July 26, 2022, NPRM. EPA has also determined that
these SIP revisions correct the deficiencies identified in the 2015 SSM
SIP Action and fully satisfy South Carolina's obligations with respect
to the SIP call included in the 2015 SSM SIP Action.

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 CAA 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. Accordingly, these actions
merely approve removal of State law not meeting Federal requirements
and do not impose additional requirements beyond those already imposed
by State law. For that reason, these actions:
     Are not significant regulatory actions 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);
     Do not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Are 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.);
     Do 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);
     Do not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Are not economically significant regulatory actions based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Are not significant regulatory actions subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Are 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
     Do 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).
    Because these final actions merely approve state law as meeting
Federal requirements and do not impose additional requirements beyond
those imposed by state law, these final actions for the State of South
Carolina do not have Tribal implications as specified by Executive
Order 13175 (65 FR 67249, November 9, 2000). Therefore, these actions
will not impose substantial direct costs on Tribal governments or
preempt Tribal law. The Catawba Indian Nation (CIN) Reservation is
located within the boundary of York County, South Carolina. Pursuant to
the Catawba Indian Claims Settlement Act, S.C. Code Ann. 27-16-120
(Settlement Act), ``all state and local environmental laws and

regulations apply to the Catawba Indian Nation and Reservation and are
fully enforceable by all relevant state and local agencies and
authorities.'' The CIN also retains authority to impose regulations
applying higher environmental standards to the Reservation than those
imposed by state law or local governing bodies, in accordance with the
Settlement Act.
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing these actions and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. These actions are not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the CAA, petitions for judicial review
of these actions must be filed in the United States Court of Appeals
for the appropriate circuit by December 12, 2022. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of these actions for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed and shall not postpone the effectiveness of such rule or
action(s). These actions may not be challenged later in proceedings to
enforce its requirements. See section 307(b)(2) of the CAA.

List of Subjects in 40 CFR Part 52

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

Daniel Blackman,
Regional Administrator, Region 4.

    For the reasons stated in the preamble, the EPA amends 40 CFR part
52 as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

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

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

Subpart PP--South Carolina

0
2. In Sec.  52.2120(c), amend the table by:
0
a. Under the undesignated heading ``Regulation No. 62.1,'' revise the
entry for ``Section II''; and
0
b. Under the undesignated heading ``Regulation No. 62.5'':
0
i. Under ``Standard No. 1,'' revise the entry for ``Section I''; and
0
ii. Under ``Standard No. 4,'' revise the entry for ``Section XI''.
    The revisions read as follows:

Sec.  52.2120   Identification of plan.

* * * * *
    (c) * * *

                                     EPA-Approved South Carolina Regulations
----------------------------------------------------------------------------------------------------------------
                                                           State
        State citation              Title/subject        effective      EPA approval date        Explanation
                                                           date
----------------------------------------------------------------------------------------------------------------
Regulation No. 62.1...........  Definitions and
                                 General
                                 Requirements.

                                                  * * * * * * *
Section II....................  Permit Requirements.       6/24/2005  6/2/2008, 73 FR       Except for Section
                                                                       31369.                II.L, approved on
                                                                                October 13, 2022
                                                                                with a state
                                                                                effective date of
                                                                                September 23, 2016.

                                                  * * * * * * *
Regulation No. 62.5...........  Air Pollution
                                 Control Standards.
Standard No. 1................  Emission from Fuel
                                 Burning Operations.
Section I.....................  Visible Emissions...       9/23/2016  10/13/2022, [Insert
                                                                       citation of
                                                                       publication].

                                                  * * * * * * *
Standard No. 4................  Emissions from
                                 Process Industries.

                                                  * * * * * * *
Section XI....................  Total Reduced Sulfur       9/23/2016  10/13/2022, [Insert
                                 Emissions of Kraft                    citation of
                                 Pulp Mills.                           publication].

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

* * * * *
[FR Doc. 2022-21972 Filed 10-12-22; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: January 9, 2008 (Volume 73, Number 6)]
[Proposed Rules]
[Page 1568-1570]
[DOCID:fr09ja08-18]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 50

[EPA-HQ-OAR-2001-0017; FRL-8502-4]
RIN 2060-AO59

Interpretation of the National Ambient Air Quality Standards for
PM2.5--Correcting and Simplifying Amendment

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: The EPA recently finalized changes to the data handling
conventions and computations necessary for determining when the annual
and 24-hour national ambient air quality standards (NAAQS) for fine
particles (generally referring to particles less than or equal to 2.5
micrometers ([mu]m) in diameter, PM2.5) are met. These
changes were made in support of revisions to the NAAQS for particulate
matter (PM) that were finalized in the same rulemaking. Following the
publication of this rule, an omission was discovered in the rule text
explaining the procedures for calculating the key statistic (98th
percentile) involved with determining compliance with the 24-hour
PM2.5 standard in locations where extra samples of
PM2.5 in ambient air were taken above the intended sampling
frequency. If the error in the regulatory text is left unchanged, the
resulting statistic for calculating compliance with the 24-hour
PM2.5 standard would be biased low at some samplers, leading
to potentially incorrect determinations that an area was attaining the
NAAQS. The EPA is proposing to correct this error. The proposed
correction involves the replacement of the currently used statistical
formula and instructions with a simpler look-up table approach which is
easier for readers to understand and which retains the originally
intended numerical consistency with EPA's historical practice.

DATES: Written comments must be received by February 8, 2008.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OAR-2001-0017, by mail to: Review of the National Ambient Air Quality
Standards (NAAQS) for Particulate Matter (PM), Environmental Protection
Agency, Mailcode: 2822T, 1200 Pennsylvania Avenue, NW., Washington, DC
20460. Please include a total of two copies. Comments may also be
submitted electronically or through hand delivery/courier by following
the detailed instructions in the ADDRESSES section of the direct final
rule located in the ``Rules and Regulations'' section of this Federal
Register.

FOR FURTHER INFORMATION CONTACT: For general questions, please contact
Mr. Lewis Weinstock, U.S. Environmental Protection Agency, Office of
Air Quality Planning and Standards, Air Quality Assessment Division,
Ambient Air Monitoring Group (C304-06), Research Triangle Park, North
Carolina 27711; telephone number:<PHONE_NUMBER>; fax number: (919)
541-1903; e-mail address<EMAIL_ADDRESS>For technical
questions, please contact Mr. Mark Schmidt, U.S. Environmental
Protection Agency, Office of Air Quality Planning and Standards, Air
Quality Assessment Division, Air Quality Analysis Group (C304-04),
Research Triangle Park, North Carolina 27711; telephone number: (919)
541-2416; fax number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION:

I. Why Is EPA Issuing This Proposed Rule?

    This document proposes to take corrective action on 40 CFR part 50,
Appendix N, Interpretation of the National Ambient Air Quality
Standards for PM2.5. We have published a direct final rule
identical to this proposal in the ``Rules and Regulations'' section of
this Federal Register. This direct final rule will correct and simplify
parts of a recent final rule published on October 17, 2006 that
finalized changes to the data handling conventions and computations
necessary for determining when the annual and 24-hour national ambient
air quality standards (NAAQS) for fine particles (generally referring
to particles less than or equal to 2.5 micrometers ([mu]m) in diameter,
PM2.5), are met. We view this as a non-controversial action
and anticipate no adverse comment. We have explained our reasons for
this action in the preamble to the direct final rule.
    If we receive no adverse comment, we will not take further action
on this proposed rule. If EPA receives relevant adverse comment on the
amendments included in this proposal, we will publish a timely
withdrawal in the Federal Register. We will address these public
comments in a subsequent final rule based on this proposal. We will not
institute a second comment period on this action. Any persons
interested in commenting must do so at this time.
    The regulatory text for the proposal is identical to that for the
direct final rule published in the ``Rules and Regulations'' section of
this Federal Register. For further supplementary information, the
detailed rationale for the proposal and the regulatory revisions, see
the direct final rule published in a separate part of this Federal
Register.

II. Does This Action Apply to Me?

    Categories and entities potentially regulated by this action
include:

------------------------------------------------------------------------
                                        NAICS     Examples of regulated
              Category                 code \1\          entities
------------------------------------------------------------------------
Federal government..................     924110  Federal agencies that
                                                  conduct ambient air
                                                  monitoring similar to
                                                  that conducted by
                                                  States under 40 CFR
                                                  part 58 and that wish
                                                  EPA to use their
                                                  monitoring data in the
                                                  same manner as State
                                                  data.
State/territorial/local/tribal           924110  State, territorial, and
 government.                                      local, air quality
                                                  management programs
                                                  that are responsible
                                                  for ambient air
                                                  monitoring under 40
                                                  CFR part 58. The
                                                  proposal also may
                                                  affect Tribes that
                                                  conduct ambient air
                                                  monitoring similar to
                                                  that conducted by
                                                  States and that wish
                                                  EPA to use their
                                                  monitoring data in the
                                                  same manner as State
                                                  monitoring data.
------------------------------------------------------------------------
\1\ North American Industry Classification System.

    This table is not intended to be exhaustive, but rather provides a
guide for readers regarding entities likely to be regulated by this
action. This table lists the types of entities that EPA is now aware of
that could potentially be regulated by this action. Other types of
entities not listed in the table could also be regulated. If you have
questions regarding the applicability of this action to a particular
entity, consult one of the persons listed in the preceding FOR FURTHER
INFORMATION CONTACT section.

III. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review

    This action is not a ``significant regulatory action'' under the
terms of Executive Order 12866 (58 FR 51735, October 4, 1993) and is
therefore not subject to review under the Executive Order.

B. Paperwork Reduction Act

    This action does not impose an information collection burden under
the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq.
There is no information collection requirement directly associated with
revisions to a NAAQS or supporting appendices under section 109 of the
CAA.
    Burden means the total time, effort, or financial resources
expended by persons to generate, maintain, retain, or disclose or
provide information to or for a Federal agency. This includes the time
needed to review instructions; develop, acquire, install, and utilize
technology and systems for the purposes of collecting, validating, and
verifying information, processing and maintaining information, and
disclosing and providing information; adjust the existing ways to
comply with any previously applicable instructions and requirements;
train personnel to be able to respond to a collection of information;
search data sources; complete and review the collection of information;
and transmit or otherwise disclose the information.
    An agency may not conduct or sponsor, and a person is not required
to respond to a collection of information unless it displays a
currently valid OMB control number. The OMB control numbers for EPA's
regulations in 40 CFR are listed in 40 CFR part 9.

C. Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA) generally requires an agency
to prepare a regulatory flexibility analysis of any rule subject to
notice and comment rulemaking requirements under the Administrative
Procedure Act or any other statute unless the agency certifies that the
rule will not have a significant economic impact on a substantial
number of small entities. Small entities include small businesses,
small organizations, and small governmental jurisdictions.
    For purposes of assessing the impacts of today's rule on small
entities, small entity is defined as: (1) A small business whose parent
company has fewer than 100 or 1,000 employees, or fewer than 4 billion
kilowatt-hr per year of electricity usage, depending on the size
definition for the affected North American Industry Classification
System code; (2) a small governmental jurisdiction that is a government
of a city, county, town, school district or special district with a
population of less than 50,000; and (3) a small organization that is
any not-for-profit enterprise which is independently owned and operated
and is not dominant in its field.
    After considering the economic impacts of this proposed rule on
small entities, I certify that this action will not have a significant
economic impact on a substantial number of small entities. This
proposed rule will not impose any requirements on small entities
because it does not impose any additional regulatory requirements. We
continue to be interested in the potential impacts of the proposed rule
on small entities and welcome comments on issues related to such
impacts.

D. Unfunded Mandates Reform Act

    Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public
Law 104-4, establishes requirements for Federal agencies to assess the
effects of their regulatory actions on State, local, and Tribal
governments and the private sector. Under section 202 of the UMRA, EPA
generally must prepare a written statement, including a cost-benefit
analysis, for proposed and final rules with ``Federal mandates'' that
may result in expenditures to State, local, and Tribal governments, in
the aggregate, or to the private sector, of $100 million or more in any
one year. Before promulgating an EPA rule for which a written statement
is needed, section 205 of the UMRA generally requires EPA to identify
and consider a reasonable number of regulatory alternatives and adopt
the least costly, most cost-effective or least burdensome alternative
that achieves the objectives of the rule. The provisions of section 205
do not apply when they are inconsistent with applicable law. Moreover,
section 205 allows EPA to adopt an alternative other than the least
costly, most cost-effective or least burdensome alternative if the
Administrator publishes with the final rule an explanation why that
alternative was not adopted. Before EPA establishes any regulatory
requirements that may significantly or uniquely affect small
governments, including Tribal governments, it must have developed under
section 203 of the UMRA a small government agency plan. The plan must
provide for notifying potentially affected small governments, enabling
officials of affected small governments to have meaningful and timely
input in the development of EPA regulatory proposals with significant
Federal intergovernmental mandates, and informing, educating, and
advising small governments on compliance with the regulatory
requirements.
    This rule contains no Federal mandates (under the regulatory
provisions of Title II of the UMRA) for State, local, or tribal
governments or the private sector. The rule imposes no enforceable duty
on any State, local or tribal governments or the private sector. The
proposed correcting and simplifying change does not create additional
regulatory requirements on affected entities compared to those that
were promulgated in the final rule that was published in the Federal
Register on October 17, 2006. The proposed rule change only corrects
and simplifies one error in Appendix N of part 50 (Interpretation of
the National Ambient Air Quality Standards for PM2.5). Thus,
this proposed rule is not subject to the requirements of section 202
and 205 of the UMRA.
    EPA has determined that this rule contains no regulatory
requirements that might significantly of uniquely affect small
governments. The proposed rule change only corrects and simplifies one
error in Appendix N of part 50.

E. Executive Order 13132: Federalism

    Executive Order 13132 (64 FR 43255, August 10, 1999), requires EPA
to develop an accountable process to ensure ``meaningful and timely
input by State and local officials in the development of regulatory
policies that have federalism implications.'' ``Policies that have
federalism implications'' is defined in the Executive Order to include
regulations that have ``substantial direct effects on the States, on
the relationship between the national government and the States, or on
the distribution of power and responsibilities among the various levels
of government.''
    This proposed rule does not have federalism implications. It will
not have substantial direct effects on the States,

on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government, as specified in Executive Order 13132. The
proposed change only corrects and simplifies one error in Appendix N of
part 50 (Interpretation of the National Ambient Air Quality Standards
for PM2.5); thus, Executive Order 13132 does not apply to
this proposed rule. In the spirit of Executive Order 13132, and
consistent with EPA policy to promote communications between EPA and
State and local governments, EPA specifically solicits comment on this
proposed rule from State and local officials.

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

    Executive Order 13175, entitled ``Consultation and Coordination
with Indian Tribal Governments'' (65 FR 67249, November 9, 2000),
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by tribal officials in the development of regulatory
policies that have tribal implications.'' This proposed rule does not
have tribal implications, as specified in Executive Order 13175. The
proposed change only corrects and simplifies one error in Appendix N of
part 50 (Interpretation of the National Ambient Air Quality Standards
for PM2.5). Thus, Executive Order 13175 does not apply to
this proposed rule.
    EPA specifically solicits additional comment on this proposed rule
from tribal officials.

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

    Executive Order 13045: ``Protection of Children from Environmental
Health Risks and Safety Risks'' (62 FR 19885, April 23,1997) applies to
any rule that: (1) Is determined to be ``economically significant'' as
defined under Executive Order 12866, and (2) concerns an environmental
health or safety risk that EPA has reason to believe may have a
disproportionate effect on children. If the regulatory action meets
both criteria, the Agency must evaluate the environmental health or
safety effects of the planned rule on children, and explain why the
planned regulation is preferable to other potentially effective and
reasonably feasible alternatives considered by the Agency.
    EPA interprets Executive Order 13045 as applying only to those
regulatory actions that are based on health or safety risks, such that
the analysis required under section 5-501 of the Order has the
potential to influence the regulation. This proposed rule is not
subject to Executive Order 13045 because, while it is based on the need
for monitoring data to characterize risk, this proposed rule itself
does not establish an environmental standard intended to mitigate
health or safety risks.

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

    This proposed rule is not subject to Executive Order 13211,
``Actions Concerning Regulations That Significantly Affect Energy
Supply, Distribution, or Use'' (66 FR 28355 (May 22, 2001)) because it
is not a significant regulatory action under Executive Order 12866.

I. National Technology Transfer Advancement Act

    Section 12(d) of the National Technology Transfer Advancement Act
of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note)
directs EPA to use voluntary consensus standards in its regulatory
activities unless to do so would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., materials specifications, test methods, sampling
procedures, and business practices) that are developed or adopted by
voluntary consensus standards bodies. The NTTAA directs EPA to provide
Congress, through OMB, explanations when the Agency decides not to use
available and applicable voluntary consensus standards.
    This proposed rulemaking does not involve any new technical
standards for environmental monitoring and measurement. Ambient air
concentrations of PM 2.5 are currently measured by the
Federal reference method in 40 CFR part 50, Appendix L (Reference
Method for the Determination of Fine Particulate as PM 2.5
in the Atmosphere) or by Federal Reference Method or Federal Equivalent
Method that meet the requirements in 40 CFR part 53.
    EPA welcomes comments on this aspect of the proposed rulemaking
and, specifically, invites the public to identify potentially-
applicable voluntary standards and to explain why such standards should
be used in this regulation.

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

    Executive Order 12898 (59 FR 7629 (Feb. 16, 1994)) establishes
federal executive policy on environmental justice. Its main provision
directs federal agencies, to the greatest extent practicable and
permitted by law, to make environmental justice part of their mission
by identifying and addressing, as appropriate, disproportionately high
and adverse human health or environmental effects of their programs,
policies, and activities on minority populations and low-income
populations in the United States.
    EPA has determined that this proposed rule will not have
disproportionately high and adverse human health or environmental
effects on minority or low-income populations because it does not
affect the level of protection provided to human health or the
environment. The proposed rule merely amends the October 17, 2006,
final PM NAAQS rule (71 FR 61144) by correcting and simplifying
existing PM 2.5 data handling conventions and computations.

List of Subjects in 40 CFR Part 50

    Environmental protection, Administrative practice and procedure,
Air pollution control, Intergovernmental relations, Reporting and
recordkeeping requirements.

    Dated: November 29, 2007.
Stephen L. Johnson,
Administrator.
[FR Doc. 07-5953 Filed 1-8-08; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 86, Number 220 (Thursday, November 18, 2021)]
[Notices]
[Pages 64465-64467]
[FR Doc No: 2021-25174]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

November 12, 2021.
    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER14-2498-012; ER14-2500-012; ER16-2462-012; ER17-
2364-006; ER19-106-005; ER21-445-002; ER16-2643-004.
    Applicants: Potomac Energy Center, LLC, Hill Top Energy Center LLC,
Birdsboro Power LLC, St. Joseph Energy Center, LLC, Oregon Clean
Energy, LLC, Newark Energy Center, LLC, EIF Newark, LLC.
    Description: Notice of Non-Material Change in Status of EIF Newark,
LLC, et al.
    Filed Date: 11/12/21.
    Accession Number: 20211112-5237.
    Comment Date: 5 p.m. ET 12/3/21.

    Docket Numbers: ER21-2652-000.
    Applicants: Caddo Wind, LLC.
    Description: Report Filing: Third Supplement to Application for
Market-Based Rate Authority to be effective N/A.
    Filed Date: 11/12/21.
    Accession Number: 20211112-5222.
    Comment Date: 5 p.m. ET 11/19/21.

    Docket Numbers: ER22-384-000.
    Applicants: ITC Midwest LLC.
    Description: Sec.  205(d) Rate Filing: Filing of a Construction
Agreement and Joint Use Agreement to be effective 1/10/2022.
    Filed Date: 11/10/21.
    Accession Number: 20211110-5195.
    Comment Date: 5 p.m. ET 12/1/21.

    Docket Numbers: ER22-385-000.
    Applicants: Innovative Owner 43, LLC.
    Description: Baseline eTariff Filing: Innovative Owner 43, LLC--
Application for Market-Based Rate Authority to be effective 11/11/2021.
    Filed Date: 11/10/21.
    Accession Number: 20211110-5241.
    Comment Date: 5 p.m. ET 12/1/21.

    Docket Numbers: ER22-386-000.
    Applicants: Portland General Electric Company.
    Description: Tariff Amendment: Portland General Electric Company
submits tariff filing per 35.15: NorthernGrid Funding Agreement
Termination to be effective 12/31/2021.
    Filed Date: 11/12/21.
    Accession Number: 20211112-5001.
    Comment Date: 5 p.m. ET 12/3/21.

    Docket Numbers: ER22-387-000.
    Applicants: Crescent Ridge LLC.
    Description: Baseline eTariff Filing: Reactive Power Compensation
Filing to be effective 12/13/2021.
    Filed Date: 11/12/21.
    Accession Number: 20211112-5013.
    Comment Date: 5 p.m. ET 12/3/21.

    Docket Numbers: ER22-388-000.
    Applicants: Public Service Company of Colorado.
    Description: Sec.  205(d) Rate Filing: 2021-11-11 PSCoES-
Provisional LGIA-657-0.0.0 to be effective 11/12/2021.
    Filed Date: 11/12/21.
    Accession Number: 20211112-5019.
    Comment Date: 5 p.m. ET 12/3/21.

    Docket Numbers: ER22-389-000.
    Applicants: Public Service Company of Colorado.
    Description: Sec.  205(d) Rate Filing: 2011-11-11 PSCoES-
Provisional LGIA-658-0.0.0 to be effective 11/12/2021.
    Filed Date: 11/12/21.
    Accession Number: 20211112-5024.
    Comment Date: 5 p.m. ET 12/3/21.

    Docket Numbers: ER22-390-000.
    Applicants: Duke Energy Carolinas, LLC.
    Description: Sec.  205(d) Rate Filing: DEC-BREMC--Revised NITSA SA
No. 367 to be effective 1/1/2022.
    Filed Date: 11/12/21.
    Accession Number: 20211112-5031.
    Comment Date: 5 p.m. ET 12/3/21.

    Docket Numbers: ER22-391-000.
    Applicants: ISO New England Inc.
    Description: ISO New England Inc submits its informational filing
for qualification in the Forward Capacity Market under 2025-2026
Capacity Commitment Period.
    Filed Date: 11/9/21.
    Accession Number: 20211109-5228.
    Comment Date: 5 p.m. ET 11/24/21.

    Docket Numbers: ER22-392-000.
    Applicants: El Paso Electric Company.
    Description: Compliance filing: EPE Order No. 864 Compliance Filing
to be effective N/A.
    Filed Date: 11/12/21.
    Accession Number: 20211112-5115.
    Comment Date: 5 p.m. ET 12/3/21.

    Docket Numbers: ER22-393-000.
    Applicants: Hardin Solar Holdings LLC.
    Description: Tariff Amendment: Notice of Cancellation of Market-
Based Rate Tariff to be effective 1/12/2022.
    Filed Date: 11/12/21.
    Accession Number: 20211112-5155.
    Comment Date: 5 p.m. ET 12/3/21.

    Docket Numbers: ER22-394-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Sec.  205(d) Rate Filing: 2888R5 Arkansas Electric
Cooperative Corp NITSA NOA to be effective 11/1/2021.
    Filed Date: 11/12/21.
    Accession Number: 20211112-5156.
    Comment Date: 5 p.m. ET 12/3/21.

    Docket Numbers: ER22-395-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Original WMPA, Service
Agreement No. 6229; Queue No. AG1-213 to be effective 11/1/2021.
    Filed Date: 11/12/21.
    Accession Number: 20211112-5158.
    Comment Date: 5 p.m. ET 12/3/21.

    Docket Numbers: ER22-396-000.
    Applicants: Equilon Enterprises LLC.
    Description: Tariff Amendment: Notice of Cancellation to be
effective 11/13/2021.
    Filed Date: 11/12/21.
    Accession Number: 20211112-5215.
    Comment Date: 5 p.m. ET 12/3/21.

    Docket Numbers: ER22-397-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: WMPA Second Amendment to
Service Agreement No. 5589; Queue No. AE2-115 to be effective 1/8/2020.
    Filed Date: 11/12/21.
    Accession Number: 20211112-5238.
    Comment Date: 5 p.m. ET 12/3/21.

    Docket Numbers: ER22-398-000.
    Applicants: Mesa Wind Power LLC.
    Description: Compliance filing: Notice of Succession and Revised
Market-Based Rate Tariff to be effective 11/13/2021.
    Filed Date: 11/12/21.
    Accession Number: 20211112-5240.
    Comment Date: 5 p.m. ET 12/3/21.

    Docket Numbers: ER22-399-000.
    Applicants: Meadow Lake Solar Park LLC.
    Description: Baseline eTariff Filing: Market-Based Rate Application
to be effective 1/12/2022.
    Filed Date: 11/12/21.
    Accession Number: 20211112-5249.
    Comment Date: 5 p.m. ET 12/3/21.

    Docket Numbers: ER22-400-000.
    Applicants: ISO New England Inc., New England Power Pool
Participants Committee.
    Description: Sec.  205(d) Rate Filing: ISO New England Inc. submits
tariff filing per 35.13(a)(2)(iii: ISO-NE and NEPOOL; Attachment K
Resource Assumption Changes to be effective 1/11/2022.
    Filed Date: 11/12/21.
    Accession Number: 20211112-5251.
    Comment Date: 5 p.m. ET 12/3/21.

    Docket Numbers: ER22-401-000.
    Applicants: Florey Knob Energy LLC.
    Description: Tariff Amendment: Florey Knob Energy LLC Cancellation
of MBR Tariff to be effective 11/13/2021.
    Filed Date: 11/12/21.
    Accession Number: 20211112-5277.
    Comment Date: 5 p.m. ET 12/3/21.

    Docket Numbers: ER22-402-000.
    Applicants: Idaho Power Company.
    Description: Sec.  205(d) Rate Filing: Section 4--Sliding Yearly
Option to be effective 12/15/2021.
    Filed Date: 11/12/21.
    Accession Number: 20211112-5296.
    Comment Date: 5 p.m. ET 12/3/21.

    Docket Numbers: ER22-403-000.

    Applicants: Public Service Company of New Mexico.
    Description: Sec.  205(d) Rate Filing: First Revised Incremental
Transmission Service Agreements to be effective 12/1/2021.
    Filed Date: 11/12/21.
    Accession Number: 20211112-5297.
    Comment Date: 5 p.m. ET 12/3/21.

    Take notice that the Commission received the following qualifying
facility filings:

    Docket Numbers: QF22-121-000.
    Applicants: Sonata Green Owner, LLC.
    Description: Form 556 of Sonata Green Owner, LLC.
    Filed Date: 11/12/21.
    Accession Number: 20211112-5212.
    Comment Date: 5 p.m. ET 12/3/21.

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

Kimberly D. Bose,
Secretary.
[FR Doc. 2021-25174 Filed 11-17-21; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 75, Number 218 (Friday, November 12, 2010)]
[Notices]
[Page 69491]
[FR Doc No: 2010-28542]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-63266; File No. SR-NYSE-2010-67]

Self-Regulatory Organizations; Order Approving Proposed Rule
Change by New York Stock Exchange LLC Changing the NYBX Order Execution
Sequence

November 5, 2010.

I. Introduction

    On September 9, 2010, the New York Stock Exchange LLC (``Exchange''
or ``NYSE'') filed with the Securities and Exchange Commission
(``Commission'') a proposed rule change, pursuant to Section 19(b)(1)
of the Securities Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4
thereunder,\2\ to change the execution of algorithm of the New York
Block Exchange (``NYBX'' or the ``Facility''), an electronic trading
facility of the NYSE. The proposed rule change was published for
comment in the Federal Register on September 24, 2010.\3\ The
Commission received no comments on the proposal. This order approves
the proposed rule change.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 62955 (September 20,
2010), 75 FR 58456 (``Notice'').
---------------------------------------------------------------------------

II. Description of the Proposal

    The NYBX is an electronic facility of the Exchange for the trading
of undisplayed orders in NYSE-listed securities.\4\ NYSE Rule 1600
governs the operation of the NYBX.
---------------------------------------------------------------------------

    \4\ See Securities Exchange Act Release No. 59282 (January 22,
2009), 74 FR 5009 (January 28, 2009) (NYSE-2008-119).
---------------------------------------------------------------------------

    When an order enters the Facility, the Facility scans its own book,
the NYSE's Display Book (``DBK'') (both displayed and undisplayed
orders), and the protected quotations of automated trading centers to
identify marketable contraside interest.\5\ Following this review, if
marketable contraside interest exists and the applicable minimum
triggering volume threshold of the incoming order is met, the Facility
will commence a sequential process for executing the incoming order. As
part of this process, the full remaining size of the incoming order
will be routed back and forth between the Facility and the DBK at each
price point, even though only a small portion of the order might be
filled at a particular price point. This ``oversizing'' allows any CCS
interest in the DBK, which the Facility is not aware of, to be
triggered at each price point. During the sequential routing process,
portions of the incoming order will be routed away to hit protected
quotations of automated trading centers as necessary to avoid trade
throughs.
---------------------------------------------------------------------------

    \5\ See NYSE Rule 1600(d)(1)(B).
---------------------------------------------------------------------------

    The NYSE proposes to change the order execution method from the
current sequential, ``oversizing'' process to a simultaneous process.
When a market evaluation indicates that sufficient marketable liquidity
exists to meet the incoming order's minimum trading volume threshold,
the Facility will divide the incoming order into separate orders that
will be routed simultaneously to execute against marketable contraside
liquidity in the DBK and/or other automated trading centers up to the
price of the incoming order. The orders routed to the DBK will no
longer be oversized. The remainder of the original order will execute,
to the extent possible, against contraside interest in the Facility at
the same or better prices. Using this approach, any orders sent by the
Facility to the DBK would not trigger any CCS interest. In addition,
the Exchange is proposing to amend the Facility's order-routing
algorithm to route away to hit the protected quotations of automated
trading centers even in some cases where it would not be necessary to
do so to avoid a trade through.\6\
---------------------------------------------------------------------------

    \6\ See proposed NYSE Rule 1600(d)(1)(C)(iii).
---------------------------------------------------------------------------

    The Exchange states that the proposal is designed to allow a NYBX
order to better capture the available contra side liquidity revealed
during the Facility's initial market evaluation. According to the NYSE,
some NYBX orders currently are not able to execute against available
contra side liquidity, because of ``the disappearance or the adjustment
of a substantial portion of the available contra side liquidity that
shows up on the initial market evaluation, before the NYBX order is
able to execute against that liquidity.'' \7\
---------------------------------------------------------------------------

    \7\ See Notice, supra note 3.
---------------------------------------------------------------------------

III. Discussion

    After careful review, the Commission finds that the proposed rule
change is consistent with the requirements of the Act and the rules and
regulations thereunder are applicable to a national securities
exchange.\8\ In particular, the Commission believes that the proposed
rule change is consistent with Section 6(b)(5) of the Act,\9\ which
requires, among other things, that an exchange have rules designed to
promote just and equitable principles of trade; to foster cooperation
and coordination with persons engaged in regulating, clearing,
settling, processing information with respect to, and facilitating
transactions in securities; to remove impediments to and perfect the
mechanism of a free and open market and a national market system; and,
in general, to protect investors and the public interest.
---------------------------------------------------------------------------

    \8\ In approving the proposed rule change, the Commission has
considered its impact on efficiency, competition, and capital
formation. See 15 U.S.C. 78c(f).
    \9\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The Commission believes that the proposal is reasonably designed to
increase the fill rates of NYBX orders in a manner consistent with
Regulation NMS, by capturing a higher percentage of the marketable
contra side liquidity that may be available for execution, as revealed
by the Facility's initial market evaluation. The proposal should also
benefit market participants whose orders are displayed at automated
trading centers, by increasing their fill rates against NYBX orders.
Accordingly, the Commission finds that the proposal is reasonably
designed to remove impediments to and perfect the mechanism of a free
and open market and a national market system, and is also consistent
with the protection of investors and the public interest.

IV. Conclusion

    It is therefore ordered, that pursuant to Section 19(b)(2) of the
Act,\10\ that the proposed rule change (SR-NYSE-2010-67) be, and it
hereby is, approved.
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78s(b)(2).
    \11\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\11\
Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-28542 Filed 11-10-10; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: November 14, 2005 (Volume 70, Number 218)]
[Notices]
[Page 69180-69181]
[DOCID:fr14no05-78]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-52746; File No. SR-NASD-2005-106]

Self-Regulatory Organizations; National Association of Securities
Dealers, Inc.; Order Approving Proposed Rule Change Regarding Fees for
Closed-End Funds Listing on the Nasdaq Capital Market

November 7, 2005.
    On August 31, 2005, the National Association of Securities Dealers,
Inc. (``NASD''), through its subsidiary, the Nasdaq Stock Market, Inc.
(``Nasdaq''), filed with the Securities and Exchange Commission
(``Commission''), pursuant to section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change regarding fees for closed-end funds listing on the
Nasdaq Capital Market.\3\ Nasdaq has proposed to amend NASD Rules 4510
and 4520 to: (i) Decrease the entry fee for listing a closed-end fund
on the Nasdaq Capital Market to $5,000 (of which $1,000 is a non-
refundable application fee) per fund; and (ii) adopt a new annual fee
schedule for closed-end funds on the Nasdaq Capital Market, which is
identical to that of funds listed on the Nasdaq National Market.\4\ The
proposed rule change was published for comment in the Federal Register
on October 3,

2005.\5\ The Commission received no comments on the proposal.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ Subsequent to the Nasdaq filing of this proposed rule,
Nasdaq filed, and the Commission approved, another proposed rule
change which renamed ``The Nasdaq SmallCap Market'' as ``The Nasdaq
Capital Market.'' See Securities Exchange Act Release No. 52489
(September 21, 2005) 70 FR 56948 (September 27, 2005).
    \4\ Nasdaq recently adopted new listing fees for Closed-End
Funds listing on the Nasdaq National Market. See Securities Exchange
Act Release No. 52277 (August 17, 2005), 70 FR 49347 (August 23,
2005) (SR-NASD-2005-096).
    \5\ See Securities Exchange Act Release No. 52515 (September 27,
2005), 70 FR 57638 (October 3, 2005).
---------------------------------------------------------------------------

    After careful review, the Commission finds that the proposed rule
change is consistent with the requirements of the Act and the rules and
regulations thereunder applicable to a self-regulatory organization.\6\
In particular, the Commission believes that the proposed rule change is
consistent with section 15A(b)(6) of the Act \7\ in that it is designed
to prevent fraudulent and manipulative acts and practices, to promote
just and equitable principles of trade, to remove impediments to and
perfect the mechanism of a free and open market and a national market
system, and, in general, to protect investors and the public interest.
---------------------------------------------------------------------------

    \6\ The Commission has considered the proposed rule's impact on
efficiency, competition and capital formation. 15 U.S.C. 78c(f).
    \7\ 15 U.S.C. 78o-3(b)(6).
---------------------------------------------------------------------------

    It is therefore ordered, pursuant to section 19(b)(2) of the
Act,\8\ that the proposed rule change (File No. SR-NASD-2005-106) be,
and hereby is, approved.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\9\
---------------------------------------------------------------------------

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

Jonathan G. Katz,
Secretary.
 [FR Doc. E5-6246 Filed 11-10-05; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 80, Number 209 (Thursday, October 29, 2015)]
[Notices]
[Page 66545]
[FR Doc No: 2015-27557]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-2138]

Agency Information Collection Activities; Announcement of Office
of Management and Budget Approval; Guidance for Industry on Adverse
Event Reporting for Outsourcing Facilities

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a
collection of information entitled ``Guidance for Industry on Adverse
Event Reporting for Outsourcing Facilities Under Section 503B of the
Federal Food, Drug and Cosmetic Act'' 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 August 4, 2015, the Agency submitted a
proposed collection of information entitled ``Guidance for Industry on
Adverse Event Reporting for Outsourcing Facilities Under Section 503B
of the Federal Food, Drug, and Cosmetic Act'' 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
0910-0800. The approval expires on September 30, 2018. A copy of the
supporting statement for this information collection is available on
the Internet at http://www.reginfo.gov/public/do/PRAMain.

    Dated: October 23, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-27557 Filed 10-28-15; 8:45 am]
BILLING CODE 4164-01-P