[Federal Register: June 17, 2008 (Volume 73, Number 117)]
[Notices]
[Page 34291]
[DOCID:fr17jn08-47]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. AD08-9-000]

Review of Wholesale Electricity Markets; Second Notice of
Conference and Agenda

June 10, 2008.
    On May 12, 2008, the Federal Energy Regulatory Commission
(Commission) issued a notice announcing a conference in this
proceeding, to be held on July 1, 2008. As mentioned in that notice,
the Commission has invited senior management and market monitors from
the jurisdictional regional transmission organizations (RTOs) and
independent system operators (ISOs) to provide a review of the current
and future state of regional wholesale electricity markets. Members of
the Commission's staff will provide an overview of the wholesale
electricity markets outside of RTOs and ISOs. Attached is the agenda
for the conference.
    The conference will be held at the Federal Energy Regulatory
Commission, 888 First Street, NE., Washington, DC 20426 in the
Commission Meeting Room (2-C) from 9:30 a.m. until 4 p.m. (EDT). All
interested persons are invited, and there is no registration required.
    This conference will be transcribed. Transcripts of the conference
will be immediately available from Ace Reporting Company<PHONE_NUMBER>
or 1-800-336-6646) for a fee. It will also be web-cast. Capitol
Connection offers the opportunity for remote listening and viewing of
the conference. It is available for a fee, live over the Internet, by
phone, or via satellite. Persons interested in receiving the broadcast,
or who need information on making arrangements should contact David
Reininger or Julia Morelli at the Capitol Connection<PHONE_NUMBER>) as
soon as possible or visit the Capitol Connection Web site at http://
www.capitolconnection.gmu.edu and click on ``FERC''.
    Commission conferences are accessible under section 508 of the
Rehabilitation Act of 1973. For accessibility accommodations please
send an e-mail to<EMAIL_ADDRESS>or call toll free 1-866-208-
3372 (voice) or<PHONE_NUMBER> (TTY), or send a FAX to<PHONE_NUMBER> with
the required accommodations.
    Questions about the conference should be directed to Saida Shaalan
by e-mail at<EMAIL_ADDRESS>or by phone at<PHONE_NUMBER>.

Kimberly D. Bose,
Secretary.

Agenda

9:30
Opening Remarks.
9:45
ISO New England, Inc., Gordon Van Welie, President and Chief Executive
Officer, Hung-po Chao, Director, Market Monitoring.
New York Independent System Operator, Karen Antion, Interim Chief
Executive Officer, David Patton, President, Potomac Economics.
PJM Independent System Operator, Inc., W. Terry Boston, President and
Chief Executive Officer, Joseph Bowring, Manager, Market Monitoring
Unit.
12
Break.
1
 California Independent System Operator, Yakout Mansour, President and
Chief Executive Officer, Keith Casey, Director, Department of Market
Monitoring, Frank Wolak, Chairman, Market Surveillance Committee.
1:45
Midwest Independent Transmission System Operator, T. Graham Edwards,
President and Chief Executive Officer, David Patton, President, Potomac
Economics.
Southwest Power Pool, Inc., Nick Brown, President and Chief Executive
Officer, Richard Dillon, Director, Market Development and Analysis.
3:15
South and West Regions, Charles Whitmore, Senior Market Advisor,
Division of Energy Market Oversight, Office of Enforcement.
4
Adjourn.
 [FR Doc. E8-13539 Filed 6-16-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 76 (Wednesday, April 20, 2011)]
[Notices]
[Pages 22162-22163]
[FR Doc No: 2011-9489]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Sixteenth Meeting: EUROCAE WG-72: RTCA Special Committee 216:
Aeronautical Systems Security (Joint Meeting)

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of EUROCAE WG-72: RTCA Special Committee 216:
Aeronautical Systems Security (Joint Meeting).

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SUMMARY: The FAA is issuing this notice to advise the public of a
meeting of EUROCAE WG-72: RTCA Special Committee 216: Aeronautical
Systems Security (Joint Meeting).

DATES: The meeting will be held May 10-13, 2011 starting at 9 a.m. to 5
p.m.

ADDRESSES: The meeting will be held at Airbus, Technical University,
Airbus Technology Center, Building 70, Nesspriel 5, 21129, Hamburg
(Finkenwerder) Germany. Email<EMAIL_ADDRESS>and
<EMAIL_ADDRESS>of your intention to attend the meeting.

FOR FURTHER INFORMATION CONTACT: RTCA Secretariat, 1828 L Street, NW.,
Suite 805, Washington, DC 20036; telephone<PHONE_NUMBER>; fax (202)
833-9434; Web site http://www.rtca.org.

SUPPLEMENTARY INFORMATION: Pursuant to section 10(a)(2) of the Federal
Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., Appendix 2), notice
is hereby given for a EUROCAE WG-72: RTCA Special Committee 216:
Aeronautical Systems Security (Joint Meeting) meeting.

Agenda

 Day 1, 9 a.m.
     Welcome/Introductions/Administrative Remarks.
     Agenda Overview and Approval.
     Split Plenary.
     SC216--Approval of the Summary of the 15th meeting held
January 18-21, 2011.
     Report on the PMC/ICC Action on TOR.
     RTCA Specific Publication Progress and Update.
     Subgroup and Action Item Reports.
     WG-72 Day 2 (9 a.m.-5 p.m.).
     Introduction/Review of the

previous MoM/Report about publications/Approval of the meeting agenda/
Election of new WG-72 secretary/Working Document Discussion/WG-72
specific concerns.
 Day 2 (9 a.m.-11 a.m.) Joint Plenary, Status of Discussions,
Layout of Publications, Issues, Concerns, and Topics to be resolved,
Priorities of work, Time Line, Mutual work items, i.e.; ED203, ED204,
and Publication Schedule planning for working documents.
 Day 2 (11 a.m.-5 p.m.) Subgroup Meetings/Break-outs.
 Day 3 -Subgroup Meetings/Break-outs.
 Day 4--(9 a.m.-12 p.m.) Subgroup Meetings/Break-outs.
 Day 4--(1:15 p.m.-4 p.m.) Joint Plenary.
     Reports on Break-outs.
     Action Item Review and Coordination.
     Establish Dates, Location and Agenda for Next Meeting(s).
     Any Other Business.
 Adjourn.
    Attendance is open to the interested public but limited to space
availability. With the approval of the chairmen, members of the public
may present oral statements at the meeting. Persons wishing to present
statements or obtain information should contact the person listed in
the FOR FURTHER INFORMATION CONTACT section. Members of the public may
present a written statement to the committee at any time.

    Issued in Washington, DC, on April 14, 2011.
Robert L. Bostiga,
RTCA Advisory Committee.
[FR Doc. 2011-9489 Filed 4-19-11; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 87, Number 104 (Tuesday, May 31, 2022)]
[Notices]
[Pages 32420-32421]
[FR Doc No: 2022-11669]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-0904]

Vaccines and Related Biological Products Advisory Committee;
Notice of Meeting; Establishment of a Public Docket; Request for
Comments

AGENCY: Food and Drug Administration, Health and Human Services (HHS).

ACTION: Notice; establishment of a public docket; request for comments.

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SUMMARY: The Food and Drug Administration (FDA or Agency) announces a
forthcoming public advisory committee meeting of the Vaccines and
Related Biological Products Advisory Committee. The general function of
the committee is to provide advice and recommendations to the Agency on
FDA's regulatory issues. Members will participate via teleconference.
This 2-day virtual meeting will be held to discuss recent requests to
amend the Emergency Use Authorization (EUA) of the Moderna COVID-19
mRNA vaccine to include the administration of a primary series to
infants, children, and adolescents 6 months through 17 years of age and
to amend the EUA of the Pfizer-BioNTech COVID-19 mRNA vaccine to
include the administration of a primary series to infants and children
6 months through 4 years of age. The meeting will be open to the public
on both days. FDA is establishing a docket for public comment on this
document.

DATES: The meeting will be held June 14 and June 15, 2022, from 8:30
a.m. to 5 p.m. Eastern Time (ET). Comments received on or before June
7, 2022, will be provided to the committee. Comments received after
June 7, 2022, and by June 13, 2022, be taken into consideration by FDA.

ADDRESSES: Please note that due to the impact of this COVID-19
pandemic, all meeting participants will be joining this advisory
committee meeting via an online teleconferencing platform. The online
web conference meeting will be available at the following separate
links on the respective days of the meeting:

Day 1: https://youtu.be/GbNpaZeDPiA
Day 2: https://youtu.be/Ixm4UmldTGQ

    FDA is establishing a docket for public comment on this meeting.
The docket number is FDA-2022-N-0904. The docket will close on June 13,
2022. Submit either electronic or written comments on this public
meeting by June 13, 2022. Please note that late, untimely filed
comments will not be considered. Electronic comments must be submitted
on or before June 13, 2022. The https://www.regulations.gov electronic
filing system will accept comments until 11:59 p.m. ET at the end of
June 13, 2022. Comments received by mail/hand delivery/courier (for
written/paper submissions) will be considered timely if they are
received on or before that date.
    Comments received on or before June 7, 2022, will be provided to
the committee. Comments received after June 7, 2022, and by June 13,
2022, will be taken into consideration by FDA. If the meeting is
canceled, FDA will continue to evaluate any relevant applications,
submissions, or information and consider any comments submitted to the
docket, as appropriate.
    You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2022-N-0904 for ``Vaccines and Related Biological Products; Notice
of Meeting; Establishment of a Public Docket; Request for Comments.''
Received comments, those filed in a timely manner (see ADDRESSES), will
be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two

copies total. One copy will include the information you claim to be
confidential with a heading or cover note that states ``THIS DOCUMENT
CONTAINS CONFIDENTIAL INFORMATION.'' FDA will review this copy,
including the claimed confidential information, in its consideration of
comments. The second copy, which will have the claimed confidential
information redacted/blacked out, will be available for public viewing
and posted on https://www.regulations.gov. Submit both copies to the
Dockets Management Staff. If you do not wish your name and contact
information be made publicly available, you can provide this
information on the cover sheet and not in the body of your comments and
you must identify the information as ``confidential.'' Any information
marked as ``confidential'' will not be disclosed except in accordance
with 21 CFR 10.20 and other applicable disclosure law. For more
information about FDA's posting of comments to public dockets, see 80
FR 56469, September 18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Prabhakara Atreya or Sussan Paydar,
Center for Biologics Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 6306, Silver
Spring, MD 20993-0002,<PHONE_NUMBER>, via email at
[email protected]; or FDA Advisory Committee Information Line, 1-
800-741-8138<PHONE_NUMBER> in the Washington, DC area). A notice in the
Federal Register about last-minute modifications that impact a
previously announced advisory committee meeting cannot always be
published quickly enough to provide timely notice. Therefore, you
should always check the Agency's website at https://www.fda.gov/advisory-committees and scroll down to the appropriate advisory
committee meeting link or call the advisory committee information line
to learn about possible modifications before joining the meeting.

SUPPLEMENTARY INFORMATION: Consistent with FDA's regulations, this
notice is being published with less than 15 days prior to the date of
the meeting based on a determination that convening a meeting of the
Vaccines and Related Biological Products Advisory Committee as soon as
possible is warranted. This Federal Register notice could not be
published 15 days prior to the date of the meeting due to recent
requests to amend the EUA of the Moderna COVID-19 mRNA vaccine to
include the administration of a primary series to infants, children,
and adolescents 6 months through 17 years of age and to amend the EUA
of the Pfizer-BioNTech COVID-19 mRNA vaccine to include the
administration of a primary series to infants and children 6 months
through 4 years of age, and the need for prompt discussion of such
requests given the COVID-19 pandemic.
    Agenda: The meeting presentations will be heard, viewed, captioned,
and recorded through an online teleconferencing platform. On June 14,
2022, under Topic 1, the committee will meet in open session to discuss
amending the EUA of the Moderna COVID-19 mRNA vaccine to include the
administration of the primary series to children and adolescents 6
years through 17 years of age. On June 15, 2022, under Topic II, the
committee will meet in open session to discuss amending the EUA of the
Moderna COVID-19 mRNA vaccine to include the administration of the
primary series to infants and children 6 months through 5 years of age
and to discuss amending the EUA of the Pfizer-BioNTech COVID-19 mRNA
vaccine to include the administration of the primary series to infants
and children 6 months through 4 years of age.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its website prior to the meeting, background
material will be made publicly available on FDA's website at the time
of the advisory committee meeting. Background material and the link to
the online teleconference meeting room will be available at https://www.fda.gov/advisory-committees/advisory-committee-calendar. Scroll
down to the appropriate advisory committee meeting link. The meeting
will include slide presentations with audio components to allow the
presentation of materials in a manner that most closely resembles an
in-person advisory committee meeting.
    Procedure: On June 14 and June 15, 2022, from 8:30 a.m. to 5 p.m.
ET, the meeting is open to the public. Interested persons may present
data, information, or views, orally or in writing, on issues pending
before the committee. All electronic and written submissions submitted
to the Docket (see ADDRESSES) on or before June 7, 2022, will be
provided to the committee. Comments received after June 7, 2022, and by
June 13, 2022, will be taken into consideration by FDA. Oral
presentations from the public will be scheduled approximately between 1
p.m. and 2 p.m. ET on June 14, 2022, and approximately between 1 p.m.
and 2 p.m. ET on June 15, 2022. Those individuals interested in making
formal oral presentations should notify the contact person and submit a
brief statement of the general nature of the evidence or arguments they
wish to present, the names and addresses of proposed participants, and
an indication of the approximate date and time requested to make their
presentation on or before 6 p.m. ET on June 8, 2022. Time allotted for
each presentation may be limited. If the number of registrants
requesting to speak is greater than can be reasonably accommodated
during the scheduled open public hearing session, FDA may conduct a
lottery to determine the speakers for the scheduled open public hearing
session. The contact person will notify interested persons regarding
their request to speak by June 10, 2022.
    For press inquiries, please contact the Office of Media Affairs at
[email protected] or<PHONE_NUMBER>.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
disabilities. If you require accommodations due to a disability, please
contact Prabhakara Atreya or Sussan Paydar ([email protected]) at
least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our website at: https://www.fda.gov/advisory-committees/about-advisory-committees/public-conduct-during-fda-advisory-committee-meetings for procedures on public conduct during
advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: May 25, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-11669 Filed 5-26-22; 11:15 am]
BILLING CODE 4164-01-P


[Federal Register Volume 85, Number 162 (Thursday, August 20, 2020)]
[Rules and Regulations]
[Pages 51335-51337]
[FR Doc No: 2020-17908]

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DEPARTMENT OF COMMERCE

Bureau of Industry and Security

15 CFR Part 744

[Docket No.<PHONE_NUMBER>]
RIN 0694-AI19

Clarification of Entity List Requirements for Listed Entities
When Acting as a Party to the Transaction Under the Export
Administration Regulations (EAR)

AGENCY: Bureau of Industry and Security, Commerce.

ACTION: Final rule.

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SUMMARY: In this final rule, the Bureau of Industry and Security (BIS)
is clarifying the supplemental license requirements for parties listed
on the Entity List pursuant to the Export Control Reform Act of 2018
(ECRA). Specifically, this final rule clarifies the Entity List's
supplemental licensing requirements to state that these end-user
controls apply to any listed entity when that entity is acting as a
purchaser, intermediate or ultimate consignee, or end-user as defined
in the Export Administration Regulations (EAR).

DATES: This rule is effective August 17, 2020.

FOR FURTHER INFORMATION CONTACT: Chair, End-User Review Committee,
Office of the Assistant Secretary for Export Administration, Bureau of
Industry and Security, Department of Commerce, Phone:<PHONE_NUMBER>,
Fax:<PHONE_NUMBER>, Email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Background

    The Entity List (Supplement No. 4 to part 744 of the Export
Administration Regulations (EAR)) identifies entities for which there
is reasonable cause to believe, based on specific and articulable
facts, that the entities have been involved, are involved, or pose a
significant risk of being or becoming involved in activities contrary
to the national security or foreign policy interests of the United
States. The EAR (15 CFR parts 730-774) impose additional license
requirements on, and limit the availability of most license exceptions
for, exports, reexports, and transfers (in-country) to listed entities.
The license review policy for each listed entity is identified in the
``License review policy'' column on the Entity List and the impact on
the availability of license exceptions is described in the relevant
Federal Register notice adding entities to the Entity List. BIS places
entities on the Entity List pursuant to part 744 (Control Policy: End-
User and End-Use Based) and part 746 (Embargoes and Other Special
Controls) of the EAR.
    The End-User Review Committee (ERC), composed of representatives of
the Departments of Commerce (Chair), State, Defense, Energy and, where
appropriate, the Treasury, makes all decisions regarding additions to,
removals from, or other modifications to the Entity List. The ERC makes
all decisions to add an entry to the Entity List by majority vote and
all decisions to remove or modify an entry by unanimous vote. The ERC
approved the clarifications of the Entity List requirements in this
rule, which will apply to all current entities on the Entity List and
subsequent additions and modifications to the Entity List.

Clarification of Entity List Requirements

    As referenced above, Sec.  744.11(a) of the EAR sets forth
supplemental license requirements applicable to exports, reexports, and
transfers (in-country) to entities listed on the Entity List, which
have been involved, are involved, or pose a significant risk of being
or becoming involved, in activities contrary to the national security
or foreign policy interests of the United States. In contrast to other
provisions of the EAR (i.e., Sec. Sec.  740.2(a)(17), 744.15(b), and
758.1(b)(8)) that set forth restrictions applicable to exports,
reexports, and transfers (in-country) to which a person listed on the
Unverified List (See: Supplement No. 6 to part 744 of the EAR) is a
party to the transaction, Sec.  744.11(a) imposes supplemental license
requirements on exports, reexports, and transfers (in-country) to
entities listed on the Entity List. Prior to publication of this final
rule, Sec.  744.11 did not explicitly address circumstances in which a
listed entity may be playing a role other than consignee or end-user in
the transaction, e.g., a purchaser or intermediate consignee.
    However, since the first set of additions pursuant to Sec.  744.11
on September 22, 2008 (73 FR 54503), Entity List rules published
through 2019 typically included a sentence in the Background section of
the rules that described the Entity List license requirements and
limitations on the use of license exceptions. The purpose of this
sentence was to alert exporters, reexporters, and transferors that BIS
intended these requirements to apply to those listed entities when
acting as any party to the transaction. The sentence specified that,

    The license requirements apply to any transaction in which items
are to be exported, reexported, or transferred (in-country) to any
of the persons or in which such persons act as purchaser,
intermediate consignee, ultimate consignee, or end-user.

    Since 2019, BIS has evaluated how to revise the EAR to better
clarify that Entity List license requirements, as specified on the
Entity List, are intended to apply to listed entities regardless of
their role as a party to a transaction.
    This final rule amends the regulatory text to clarify that Entity
List license requirements apply to entities on the Entity List, not
only when they are party to a transaction as either an ultimate
consignee or end-user, but also when they are party as a purchaser or
intermediate consignee.
    Consistent with the authority granted under Sec.  4812(c) of ECRA,
BIS is amending Sec. Sec.  744.11 and 744.16 of the EAR and the
introductory text of the Entity List in Supplement No. 4 to part 744 to
specify that the Entity List

requirements apply to all entities involved in a transaction subject to
the EAR as described in Sec.  748.5(c)-(f) of the EAR. These changes
will make clear for exporters, reexporters, and transferors the scope
of the Entity List's licensing requirements to effect the purpose of
the Entity List.
    As BIS has noted in the answers to frequently asked questions on
its website, freight forwarders and other ``intermediate consignees''
may have access to items subject to the EAR, which creates a risk of
diversion when such entities are listed on the Entity List. Similarly,
a ``purchaser'' may coordinate all aspects of the purchase of items
subject to the EAR from specifying the exporter, reexporter, or
transferor, including designating the ultimate consignee who will
receive the goods, to specifying the logistical arrangements made to
effect delivery of the items to the ultimate consignee. Accordingly,
when a person is listed on the Entity List, that person's participation
as a purchaser or intermediate consignee in an export, reexport, or
transfer (in-country) of items subject to the EAR presents a risk that
the person's involvement in a transaction may circumvent the basis for
their inclusion on the Entity List.
    These clarifications to the Entity List requirements align with
other end-user controls under the EAR. Specifically, as noted above,
this language revision is consistent with EAR controls pursuant to
Sec.  744.15(b), which set forth restrictions applicable to exports,
reexports, and transfers (in-country) involving persons listed on the
Unverified List. BIS has determined that aligning the language of the
Entity List and Unverified List requirements should ease the compliance
burden on exporters, reexporters, and transferors because it will
eliminate any confusion in interpretation of these two end-user control
lists.

Changes Made to the EAR

    In this final rule, BIS is revising Sec.  744.11(a) of the EAR to
specify that supplemental license requirements for entities included on
the Entity List apply regardless of the role that the listed entity has
in the transaction (i.e., purchaser, intermediate consignee, ultimate
consignee or end-user). The definitions of ``purchaser,''
``intermediate consignee,'' ``ultimate consignee,'' and ``end-user''
are defined in Sec.  748.5(c)-(f) and part 772 of the EAR.
    Also in Sec.  744.11(a), BIS is removing text indicating that the
scope of the license requirements apply only to an entity listed on the
Entity List ``in an entry that contains a reference to this section.''
BIS is removing this text because it is not consistent with the current
practice of including references in Entity List entries to other parts
of the EAR that set forth the scope of the supplemental license
requirements and license review policies applicable to those entities.
This final rule also makes conforming changes to the remainder of Sec.
744.11.
    BIS is also revising Sec.  744.16(a) of the EAR, which similarly
clarifies that the supplemental license requirements applicable to
exports, reexports, and transfers (in-country) to entities listed on
the Entity List, including on the basis of other sections of parts 744
(e.g., Sec. Sec.  744.2, 744.3, and 744.4) and 746. In keeping with the
revision to Sec.  744.11(a) described above, BIS is also clarifying
that the license requirement described in Sec.  744.16(a) applies
whenever an entity listed on the Entity List is a party to the
transaction as defined in Sec.  748.5(c)-(f) of the EAR.
    Finally, BIS is replacing the reference to ``items listed in an
entry on the Entity List'' in Sec.  744.16(a) of the EAR with a
reference to the License Requirement column on the Entity List. BIS is
making this change because the License Requirement column describes
which items subject to the EAR require a license when an entity
involved in a transaction is listed on the Entity List.

Export Control Reform Act of 2018

    On August 13, 2018, the President signed into law the John S.
McCain National Defense Authorization Act for Fiscal Year 2019, which
included the Export Control Reform Act of 2018 (ECRA), 50 U.S.C. 4801-
4852. ECRA provides the legal basis for BIS's principal authorities and
serves as the authority under which BIS issues this rule.

Rulemaking Requirements

    1. Executive Orders 13563 and 12866 direct agencies to assess all
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, distributive impacts, and equity). Executive
Order 13563 emphasizes the importance of quantifying both costs and
benefits, of reducing costs, of harmonizing rules, and of promoting
flexibility. This rule has been determined to be not significant for
purposes of Executive Order 12866. This rule is not an Executive Order
13771 regulatory action because this rule is not significant under
Executive Order 12866.
    2. Notwithstanding any other provision of law, no person is
required to respond to nor be subject to a penalty for failure to
comply with a collection of information, subject to the requirements of
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.), unless
that collection of information displays a currently valid Office of
Management and Budget (OMB) Control Number. This regulation involves
collections previously approved by OMB under control number 0694-0088,
Simplified Network Application Processing System, which includes, among
other things, license applications and carries a burden estimate of
42.5 minutes for a manual or electronic submission. BIS expects this
rule will slightly increase the number of license applications required
to be submitted to BIS each year by clarifying that the existing Entity
List requirements apply to exports, reexports, and transfers (in-
country) in which an entity listed on the Entity List acts as any party
to the transaction, which will now include when the listed entity is a
purchaser or intermediate consignee. BIS estimates the total number of
additional license applications will not exceed 25 per year, for a
total increase in public burden under OMB control number 0694-0088 of
no more than 17 hours and 40 minutes per year. Any comments regarding
the collection of information associated with this rule, including
suggestions for reducing the burden, may be sent to Jasmeet K. Seehra,
Office of Management and Budget (OMB), by email to
<EMAIL_ADDRESS>or online at https://www.reginfo.gov/public/do/PRAMain.
    3. This rule does not contain policies with Federalism implications
as that term is defined in Executive Order 13132.
    4. Pursuant to Sec.  1762 of the Export Control Reform Act of 2018
(50 U.S.C. 4801-4852), which was included in the John S. McCain
National Defense Authorization Act for Fiscal Year 2019, this action is
exempt from the Administrative Procedure Act (5 U.S.C. 553)
requirements for notice of proposed rulemaking, opportunity for public
participation, and delay in effective date.
    5. Because a notice of proposed rulemaking and an opportunity for
public comment are not required to be given for this rule by 5 U.S.C.
553, or by any other law, the analytical requirements of the Regulatory
Flexibility Act, 5 U.S.C. 601, et seq., are not applicable.
Accordingly, no

regulatory flexibility analysis is required and none has been prepared.

List of Subjects in 15 CFR Part 744

    Exports, Reporting and recordkeeping requirements, Terrorism.

    Accordingly, part 744 of the Export Administration Regulations (15
CFR parts 730-774) is amended as follows:

PART 744--CONTROL POLICY: END-USE AND END-USER BASED

0
1. The authority citation for part 744 is revised to read as follows:

    Authority:  50 U.S.C. 4801-4852; 50 U.S.C. 4601 et seq.; 50
U.S.C. 1701 et seq.; 22 U.S.C. 3201 et seq.; 42 U.S.C. 2139a; 22
U.S.C. 7201 et seq.; 22 U.S.C. 7210; E.O. 12058, 43 FR 20947, 3 CFR,
1978 Comp., p. 179; E.O. 12851, 58 FR 33181, 3 CFR, 1993 Comp., p.
608; E.O. 12938, 59 FR 59099, 3 CFR, 1994 Comp., p. 950; E.O. 13026,
61 FR 58767, 3 CFR, 1996 Comp., p. 228; E.O. 13099, 63 FR 45167, 3
CFR, 1998 Comp., p. 208; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp.,
p. 783; E.O. 13224, 66 FR 49079, 3 CFR, 2001 Comp., p. 786; Notice
of September 19, 2019, 84 FR 49633 (September 20, 2019); Notice of
November 12, 2019, 84 FR 61817 (November 13, 2019).

0
2. Section 744.11 is amended by revising paragraph (a) to read as
follows:

Sec.  744.11  License requirements that apply to entities acting
contrary to the national security or foreign policy interests of the
United States.

* * * * *
    (a) License requirement, availability of license exceptions, and
license application review policy. A license is required, to the extent
specified on the Entity List, to export, reexport, or transfer (in-
country) any item subject to the EAR when an entity that is listed on
the Entity List is a party to the transaction as described in Sec.
748.5(c) through (f). License exceptions may not be used unless
authorized in the Entity List entry for the entity that is party to the
transaction. Applications for licenses required by this section will be
evaluated as stated in the Entity List entry for the entity that is
party to the transaction, in addition to any other applicable review
policy stated elsewhere in the EAR.
* * * * *

0
3. Section 744.16 is amended by revising paragraph (a) to read as
follows:

Sec.  744.16   Entity List.

* * * * *
    (a) License requirements. In addition to the license requirements
for items specified on the Commerce Control List (CCL), you may not,
without a license from BIS, export, reexport, or transfer (in-country)
any items included in the License Requirement column of an entity's
entry on the Entity List (supplement No. 4 to this part) when that
entity is a party to a transaction as described in Sec.  748.5(c)
through (f) of the EAR. The specific license requirement for each
listed entity is identified in the license requirement column on the
Entity List in Supplement No. 4 to this part.
* * * * *

0
4. Supplement No. 4 to part 744 is amended by revising the introductory
text of the supplement to read as follows:

Supplement No. 4 to Part 744--Entity List

    This Supplement lists certain entities subject to license
requirements for specified items under this part 744 and part 746 of
the EAR. License requirements for these entities include exports,
reexports, and transfers (in-country) unless otherwise stated. A
license is required, to the extent specified on the Entity List, to
export, reexport, or transfer (in-country) any item subject to the
EAR when an entity that is listed on the Entity List is a party to
the transaction as described in Sec.  748.5(c) through (f). This
list of entities is revised and updated on a periodic basis in this
Supplement by adding new or amended notifications and deleting
notifications no longer in effect.
* * * * *

Matthew S. Borman,
Deputy Assistant Secretary for Export Administration.
[FR Doc. 2020-17908 Filed 8-17-20; 2:30 pm]
BILLING CODE 3510-33-P


[Federal Register Volume 77, Number 118 (Tuesday, June 19, 2012)]
[Notices]
[Pages 36587-36589]
[FR Doc No: 2012-14908]

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SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of Investor Education and Advocacy, Washington, DC
20549-0213.

Extension:
    Rule 12b-1; SEC File No. 270-188; OMB Control No. 3235-0212.

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (the ``Commission'') is soliciting comments on the
collection of information summarized below. The Commission plans to
submit this existing collection of information to the Office of
Management and Budget for extension and approval.

    Rule 12b-1 under the Investment Company Act of 1940 (17 CFR
270.12b-1) permits a registered open-end investment company (``fund''
or ``mutual fund'') to bear expenses associated with the distribution
of its shares, provided that the mutual fund complies with certain
requirements, including, among other things, that it adopt a written
plan (``rule 12b-1 plan'') and that it has in writing any agreements
relating to the rule 12b-1 plan. The rule in part requires that (i) the
adoption or material amendment of a rule 12b-1 plan be approved by the
mutual fund's directors, including its independent directors, and, in
certain circumstances, its shareholders; (ii) the board review
quarterly reports of amounts spent under the rule 12b-1 plan; and (iii)
the board, including the independent directors, consider continuation
of the rule 12b-1 plan and any related agreements at least annually.
Rule 12b-1 also requires mutual funds relying on the rule to preserve
for six years, the first two years in an easily accessible place,
copies of the rule 12b-1 plan and any related agreements and reports,
as well as minutes of board meetings that describe the factors
considered and the basis for adopting or continuing a rule 12b-1 plan.
    Rule 12b-1 also prohibits funds from paying for distribution of
fund shares with brokerage commissions on their portfolio transactions.
The rule requires funds that use broker-dealers that sell their shares
to also execute their portfolio securities transactions, to implement
policies and procedures reasonably designed to prevent: (i) The persons
responsible for selecting broker-dealers to effect transactions in fund
portfolio securities from taking into account broker-dealers'
promotional or sales efforts when making those decisions; and (ii) a
fund, its adviser or principal underwriter, from entering into any
agreement under which the fund directs brokerage transactions or
revenue generated by those transactions to a broker-dealer to pay for
distribution of the fund's (or any other fund's) shares.
    The board and shareholder approval requirements of rule 12b-1 are
designed to ensure that fund shareholders and directors receive
adequate information to evaluate and approve a rule 12b-1 plan and,
thus, are necessary for investor protection. The requirement of
quarterly reporting to the board is designed to ensure that the rule
12b-1 plan continues to benefit the fund and its shareholders. The
recordkeeping requirements of the rule are necessary to enable
Commission staff to oversee compliance with the rule. The requirement
that funds or their advisers implement, and fund boards approve,
policies and procedures in order to prevent persons charged with
allocating fund brokerage from taking distribution efforts into account
is designed to ensure that funds' selection of brokers to effect
portfolio securities transactions is not influenced by considerations
about the sale of fund shares.
    Based on information filed with the Commission by funds, Commission
staff estimates that there are approximately 6,771 mutual fund
portfolios that have at least one share class subject to a rule 12b-1
plan.\1\ However, many of these portfolios are part of an affiliated
group of funds, or mutual fund family, that is overseen by a common
board of directors. Although the board must review and approve the rule
12b-1 plan for each fund separately, we have allocated the costs and
hourly burden related to rule 12b-1 based on the number of fund
families that have at least one fund that charges rule 12b-1 fees,
rather than on the total number of mutual fund portfolios that
individually have a rule 12b-1 plan.\2\ Based on information filed with
the Commission, the staff estimates that there are approximately 375
fund families with common boards of directors that have at least one
fund with a rule 12b-1 plan.
---------------------------------------------------------------------------

    \1\ This estimate is based on information from the Commission's
NSAR database.
    \2\ This allocation is based on previous conversations with fund
representatives on how fund boards comply with the requirements of
rule 12b-1. Despite this allocation of hourly burdens and costs, the
number of annual responses each year will continue to depend on the
number of fund portfolios with rule 12b-1 plans rather than the
number of fund families with rule 12b-1 plans. The staff estimates
that the number of annual responses per fund portfolio will be four
per year (quarterly, with the annual reviews taking place at one of
the quarterly intervals). Thus, we estimate that funds will make
27,084 responses (6,771 fund portfolios x 4 responses per fund
portfolio = 27,084 responses) each year.
---------------------------------------------------------------------------

    Based on previous conversations with fund representatives,
Commission staff estimates that for each of the 375 mutual fund
families with a portfolio that has a rule 12b-1 plan, the average
annual burden of complying with the rule is 425 hours. This estimate
takes into account the time needed to prepare quarterly reports to the
board of directors, the board's consideration of those reports, and the
board's initial or annual consideration of whether to continue the
plan.\3\ We therefore estimate that the total hourly burden per year
for all funds to comply with current information collection
requirements under rule 12b-1, is 159,375 hours (375 fund families x
425 hours per fund family = 159,375 hours).
---------------------------------------------------------------------------

    \3\ We do not estimate any costs or time burden related to the
recordkeeping requirements in rule 12b-1, as funds are either
required to maintain these records pursuant to other rules or would
keep these records in any case as a matter of business practice.
---------------------------------------------------------------------------

    If a currently operating fund seeks to (i) adopt a new rule 12b-1
plan or (ii) materially increase the amount it spends for distribution
under its rule 12b-1 plan, rule 12b-1 requires that the fund obtain
shareholder approval. As a consequence, the fund will incur the cost of
a proxy.\4\ Based on previous conversations with fund representatives,
Commission staff estimates that approximately three funds per year
prepare a proxy in connection with the adoption or material amendment
of a rule 12b-1 plan. Funds typically hire outside legal counsel and
proxy solicitation firms to prepare, print, and mail such proxies. The
staff further estimates that the cost of each fund's proxy is $32,174.
Thus the total annual cost burden of rule 12b-1 to the fund industry is
$96,522 (3 funds requiring a proxy x $32,174 per proxy).
---------------------------------------------------------------------------

    \4\ In general, a fund adopts a rule 12b-1 plan before it begins
operations. Therefore, the fund is not required to obtain the
approval of its public shareholders because the fund's shares have
not yet been offered to the public.
---------------------------------------------------------------------------

    The estimate of average burden hours is made solely for the
purposes of the Paperwork Reduction Act, and is not derived from a
comprehensive or even a representative survey or study of the costs of
Commission rules and forms.
    The collections of information required by Rule 12b-1 are necessary
to obtain the benefits of the rule. Notices to the Commission will not
be kept confidential. An agency may not conduct or sponsor, and a
person is not required to respond to a collection of information unless
it displays a currently valid control number.
    Written comments are invited on: (a) Whether the proposed
collection of information is necessary for the proper performance of
the functions of the Commission, including whether the information will
have practical utility; (b) the accuracy of the Commission's estimate
of the burden of the collection of information; (c) ways to enhance the
quality, utility, and clarity of the information collected; and (d)
ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques or other forms of information technology. Consideration will
be given to comments and suggestions submitted in writing within 60
days of this publication.
    Please direct your written comments to Thomas Bayer, Director/Chief
Information Officer, Securities and Exchange Commission, c/o Remi
Pavlik-

Simon, 6432 General Green Way, Alexandria, VA 22312; or send an email
to<EMAIL_ADDRESS>
    Dated: June 14, 2012.
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-14908 Filed 6-18-12; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 86, Number 27 (Thursday, February 11, 2021)]
[Proposed Rules]
[Pages 9041-9043]
[FR Doc No: 2021-02759]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R06-OAR-2020-0166; FRL-10017-19-Region 6]

Air Plan Approval; Texas; Clean Air Act Requirements for
Nonattainment New Source Review and Emission Statements for the 2015
Ozone National Ambient Air Quality Standards

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: Pursuant to the Federal Clean Air Act (CAA or the Act), the
Environmental Protection Agency (EPA) is proposing to approve the
portions of a State Implementation Plan (SIP) revision submitted by the
State of Texas that describes how CAA requirements for Nonattainment
New Source Review (NNSR) and emission statements are met in the Dallas-
Fort Worth (DFW), Houston-Galveston-Brazoria (HGB), and Bexar County
ozone nonattainment areas for the 2015 ozone National Ambient Air
Quality Standards (NAAQS).

DATES: Written comments must be received on or before March 15, 2021.

ADDRESSES: Submit your comments, identified by Docket No. EPA-R06-OAR-
2020-0166, at https://www.regulations.gov or via email to
<EMAIL_ADDRESS>Follow the online instructions for submitting
comments. Once submitted, comments cannot be edited or removed from
Regulations.gov. The 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. 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). For
additional submission methods, please contact Carl Young,<PHONE_NUMBER>,
<EMAIL_ADDRESS>For 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.
    Docket: The index to the docket for this action is available
electronically at www.regulations.gov. While all documents in the
docket are listed in the index, some information may not be publicly
available due to docket file size restrictions or content (e.g., CBI).

FOR FURTHER INFORMATION CONTACT: Carl Young, EPA Region 6 Office,
Infrastructure and Ozone Section,<PHONE_NUMBER><EMAIL_ADDRESS>Out
of an abundance of caution for members of the public and our staff, the
EPA Region 6 office will be closed to the public to reduce the risk of
transmitting COVID-19. We encourage the public to submit comments via
https://www.regulations.gov, as there will be a delay in processing
mail and no courier or hand deliveries will be accepted. Please call or
email the contact listed above if you need alternative access to
material indexed but not provided in the docket.

SUPPLEMENTARY INFORMATION: Throughout this document wherever ``we,''
``us,'' or ``our'' is used, we mean the EPA.

I. Background

    Ground-level ozone is a gas that is formed by the reaction of
Volatile Organic Compounds (VOC) and Oxides of Nitrogen
(NOX) in the atmosphere in the presence of sunlight. These
precursors (VOC and NOX) are emitted by many types of
pollution sources, including point sources such as power plants and
industrial emissions sources; on-road and off-road mobile sources
(motor vehicles and engines); and smaller residential and commercial
sources, such as dry cleaners, auto body shops, and household paints,
collectively referred to as area sources. Ozone is predominately a
summertime air pollutant (83 FR 25777, June 4, 2018).
    On October 1, 2015, we revised the ozone NAAQS to a level of 0.070
parts per million (ppm) (annual fourth-highest daily maximum 8-hour
average concentration, averaged over 3 years). See 80 FR 65296, October
26, 2015; and 40 CFR 50, appendix U for more information on the revised
2015 ozone NAAQS, including a detailed explanation of the calculation
of the 3-year 8-hour average. The revised 2015 ozone NAAQS provide
greater protection of public health and the environment than the
previous ozone NAAQS of 0.075 ppm, set in 2008. Although the 2015 ozone
NAAQS retain the same general form and averaging time as the NAAQS set
in 2008, the lower level is more protective.
    The DFW and HGB areas were classified as Marginal ozone
nonattainment areas for the 2015 ozone NAAQS with an attainment
deadline of August 3, 2021 (83 FR 25776, June 4, 2018). Bexar County
(which includes the City of San Antonio) was also classified as a
Marginal ozone nonattainment area with an attainment deadline of
September 24, 2021 (83 FR 35136, July 25, 2018). The DFW area consists
of Collin, Dallas, Denton, Ellis, Johnson, Kaufman, Parker, Tarrant,
and Wise Counties. The HGB area consists of Brazoria, Chambers, Fort
Bend, Galveston, Harris, and Montgomery Counties.
    On June 24, 2020, Texas submitted a SIP revision for the DFW, HGB
and Bexar County areas. The SIP revision included a description of how
provisions previously approved by EPA meet the 2015 ozone NAAQS
Marginal area CAA requirements for (1) NNSR

and (2) Emission Statements from stationary point sources. A copy of
the SIP revision is available online at www.regulations.gov, Docket
number EPA-R06-OAR-2020-0166. In the SIP revision submittal, Texas
determined that the NNSR SIP requirements of CAA section 182(a)(2)(C)
are met for the 2015 NAAQS as the Texas SIP already includes 30 TAC
Section 116.12 (Nonattainment and Prevention of Significant
Deterioration Review Definitions) and 30 TAC Section 116.150 (New Major
Source or Major Modification in Ozone Nonattainment Area). Texas also
determined that 30 TAC Section 101.10 (Emissions Inventory
Requirements) of the Texas SIP, which requires that stationary sources
report NOX and VOC emissions, continues to address the
emissions statements requirement of CAA section 182(a)(3)(B) for the
2015 ozone NAAQS.

II. The EPA's Evaluation

A. CAA Requirements for NNSR

    A NNSR permitting program for ozone nonattainment areas is required
by the CAA section 182(a)(2)(C). The NNSR requirements are further
defined in 40 CFR 51 Subpart I (Review of New Sources and
Modifications). NNSR permits for ozone authorize construction of new
major sources or major modifications of existing sources of
NOX or VOC in an area that is designated nonattainment for
the ozone NAAQS. Emissions thresholds and pollutant offset requirements
under the NNSR program are based on the nonattainment area's
classification. Under these requirements new major sources or major
modifications at existing sources in an ozone nonattainment area must
comply with the lowest achievable emission rate and obtain sufficient
emission offsets for emissions of NOX or VOC. For Marginal
ozone nonattainment areas, major sources are any stationary source or
group of sources located within a contiguous area and under common
control that emits, or has the potential to emit, at least 100 tons per
year of NOX or VOC (CAA sections 182(c) and 182(f)). The
NNSR offset ratio for Marginal ozone nonattainment areas must be at
least 1.1 to 1 (CAA section 182(a)(4)). As noted by the State, the
Texas SIP already includes 30 TAC Section 116.12 (Nonattainment and
Prevention of Significant Deterioration Review Definitions) and 30 TAC
Section 116.150 (New Major Source or Major Modification in Ozone
Nonattainment Area). For the Bexar County area these provisions require
new major sources or major modifications at existing sources, that emit
or has the potential to emit, at least 100 tons per year of
NOX or VOC, to comply with the lowest achievable emission
rate (LAER) and obtain emission offsets at the Marginal classification
ratio of 1.1 to 1.
    More stringent NNSR requirements apply to the counties in the DFW
and HGB areas as they are also classified as Serious nonattainment for
the 2008 ozone standard of 0.075 ppm (40 CFR 81.344). For the DFW and
HGB areas, these provisions require new major sources or major
modifications at existing sources, that emit or has the potential to
emit, at least 50 tons per year of NOX or VOC, to comply
with the LAER and obtain emission offsets at the Serious classification
ratio of 1.2 to 1. In 1995, we approved Texas' NNSR program for ozone,
which includes Marginal and Serious classification requirements under
CAA section 182 (60 FR 49781, September 27, 1995). Most recently, we
approved revisions to the Texas SIP to address NNSR requirements in
2012 (77 FR 65119, October 25, 2012) and 2014 (79 FR 66626, November
10, 2014). Therefore, since the Texas SIP includes approved provisions
addressing the CAA NNSR requirements for ozone nonattainment areas
classified as Marginal, we are proposing to approve this portion of the
SIP revision.

B. CAA Requirements for Emissions Statements

    CAA section 182(a)(3)(B) calls for SIPs for all ozone nonattainment
areas to require that the owner or operator of each stationary source
of NOX or VOC provide the State with an annual statement of
emissions along with a certification that the information is accurate
to the best knowledge of the individual certifying the statement. As
noted by the State, the Texas SIP includes 30 TAC Section 101.10
(Emissions Inventory Requirements). The certification for emission
statements is found at 30 TAC Section 101.10(d) (Certifying statement).
We initially approved this certification as meeting the CAA emission
statement requirement in 1994 (59 FR 44036, August 26, 1994). Most
recently we approved revisions to 30 TAC Section 101.10 in 2017 (82 FR
26598, June 8, 2017). The most recently EPA-approved Texas regulation
continues to include appropriate provisions so that the owner or
operator of each stationary source must provide the State with a
statement with each emissions inventory attesting that the information
contained in the inventory is true and accurate to the best knowledge
of the certifying official (30 TAC Section 101.10(d)(1)). Therefore,
since the Texas SIP includes approved provisions addressing the CAA
emission statement requirement, we are proposing to approve this
portion of the SIP revision.

III. Proposed Action

    We are proposing to approve portions of a SIP revision submitted by
the State of Texas on June 24, 2020, that describes how CAA
requirements for NNSR and emission statements are met in the DFW, HGB,
and Bexar County ozone nonattainment areas for the 2015 ozone NAAQS.

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. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, the EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, 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 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).
    In addition, 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 proposed rule does not have tribal implications and will
not impose substantial direct costs on tribal governments or preempt
tribal law as specified by Executive Order 13175 (65 FR 67249, November
9, 2000).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Nitrogen dioxide, Ozone, Reporting and record keeping
requirements, Volatile organic compounds.

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

    Dated: February 5, 2021.
David Gray,
Acting Regional Administrator, Region 6.
[FR Doc. 2021-02759 Filed 2-10-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 76, Number 186 (Monday, September 26, 2011)]
[Notices]
[Pages 59404-59405]
[FR Doc No: 2011-24602]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0002]

Gastrointestinal Drugs Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
    Name of Committee: Gastrointestinal Drugs Advisory Committee.
    General Function of the Committee: To provide advice and
recommendations to the Agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on November 16, 2011, from
8 a.m. to 5 p.m.
    Location: Holiday Inn Washington-College Park, The Ballroom, 10000
Baltimore Ave., College Park, MD. The hotel telephone number is 301-
345-6700.
    Contact Person: Kristine T. Khuc, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
31, rm. 2417, Silver Spring, MD 20993-0002,<PHONE_NUMBER>, fax: 301-847-
8533, e-mail<EMAIL_ADDRESS>or FDA Advisory Committee Information
Line, 1-800-741-8138<PHONE_NUMBER> in the Washington, DC area), and
follow the prompts to the desired center or product area. Please call
the Information Line for up-to-date information on this meeting. A
notice in the Federal Register about last minute modifications that
impact a previously announced advisory committee meeting cannot always
be published quickly enough to provide timely notice. Therefore, you
should

always check the Agency's Web site and call the appropriate advisory
committee hot line/phone line to learn about possible modifications
before coming to the meeting.
    Agenda: On November 16, 2011, the committee will discuss the design
of clinical trials to evaluate the safety, efficacy, and durability of
response with repeat treatment cycles of XIFAXAN (rifaximin), by Salix
Pharmaceuticals, Inc., for irritable bowel syndrome with diarrhea.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
November 1, 2011. Oral presentations from the public will be scheduled
between approximately 1 p.m. and 2 p.m. Those individuals interested in
making formal oral presentations should notify the contact person and
submit a brief statement of the general nature of the evidence or
arguments they wish to present, the names and addresses of proposed
participants, and an indication of the approximate time requested to
make their presentation on or before October 24, 2011. Time allotted
for each presentation may be limited. If the number of registrants
requesting to speak is greater than can be reasonably accommodated
during the scheduled open public hearing session, FDA may conduct a
lottery to determine the speakers for the scheduled open public hearing
session. The contact person will notify interested persons regarding
their request to speak by October 25, 2011.
    Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Kristine T. Khuc at
least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: September 20, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2011-24602 Filed 9-23-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 82, Number 73 (Tuesday, April 18, 2017)]
[Notices]
[Page 18292]
[FR Doc No: 2017-07813]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL 9961-47-OARM]

Good Neighbor Environmental Board

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of Federal Advisory Committee Teleconference Meeting.

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SUMMARY: Pursuant to the Federal Advisory Committee Act, Public Law 92-
463, notice is hereby given that the Good Neighbor Environmental Board
will hold a public teleconference meeting on Thursday, May 11, 2017.
The meeting is open to the public.

DATES: The Good Neighbor Environmental Board will hold an open
teleconference meeting on Thursday, May 11, 2017 from 12 p.m. to 4:00
p.m. EDT.
    Purpose of Meeting: The purpose of this meeting is to discuss the
Board's next report, which is examining environmental protection and
security issues in the U.S.--Mexico border region.
    General Information: The agenda for the teleconference will be
available at http://www2.epa.gov/faca/gneb. General information about
the Board can be found on its Web site at http://www2.epa.gov/faca/gneb. If you wish to make oral comments or submit written comments to
the Board, please contact Mark Joyce at least five days prior to the
meeting. Written comments should be submitted to Mark Joyce at
<EMAIL_ADDRESS>    Meeting Access: For information on access or services for
individuals with disabilities, please contact Mark Joyce at (202) 564-
2130 or email at<EMAIL_ADDRESS>To request accommodation of a
disability, please contact Mark Joyce at least 10 days prior to the
meeting to give EPA as much time as possible to process your request.

    Dated: April 3, 2017.
Mark Joyce,
Acting Designated Federal Officer.
[FR Doc. 2017-07813 Filed 4-17-17; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 80, Number 134 (Tuesday, July 14, 2015)]
[Rules and Regulations]
[Pages 40905-40909]
[FR Doc No: 2015-17057]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2015-0297; FRL-9930-28-Region 9

Partial Approval and Partial Disapproval of Air Quality State
Implementation Plans; Arizona; Infrastructure Requirements for Lead and
Ozone

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is partially
approving and partially disapproving State Implementation Plan (SIP)
revisions submitted by the State of Arizona to address the requirements
of section 110(a)(1) and (2) of the Clean Air Act (CAA) for the 2008
Lead (Pb) and 2008 ozone national ambient air quality standards
(NAAQS). Section 110(a) of the CAA requires that each State adopt and
submit a SIP for the implementation, maintenance, and enforcement of
each NAAQS promulgated by EPA. We refer to such SIP revisions as
``infrastructure'' SIPs because they are intended to address basic
structural SIP requirements for new or revised NAAQS including, but not
limited to, legal authority, regulatory structure, resources, permit
programs, monitoring, and modeling necessary to assure attainment and
maintenance of the standards.

DATES: This final rule is effective on August 13, 2015.

ADDRESSES: EPA has established a docket for this action, identified by
Docket ID Number EPA-R09-OAR-2015-0297. The index to the docket for
this action is available electronically at http://www.regulations.gov
and in hard copy at EPA Region IX, 75 Hawthorne, San Francisco,
California. While all documents in the docket are listed in the index,
some information may be publically available only at the hard copy
location (e.g., copyrighted material) and some may not be publically
available in either location (e.g., confidential business information
(CBI)). To inspect the hard copy materials, please schedule an
appointment during normal business hours with the contact listed
directly below.

FOR FURTHER INFORMATION CONTACT: Jeffrey Buss, Office of Air Planning,
U.S. Environmental Protection Agency, Region 9,<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, the terms ``we,''
``us,'' and ``our'' refer to EPA.

Table of Contents

I. Background
II. Proposed Action
III. Public Comments and EPA Responses
IV. Final Action
V. Statutory and Executive Order Reviews

I. Background

    CAA section 110(a)(1) requires each state to submit to EPA, within
three years after the promulgation of a primary or secondary NAAQS or
any revision thereof, an infrastructure SIP revision that provides for
the implementation, maintenance, and enforcement of such NAAQS. Section
110(a)(2) sets the content requirements of such a plan, which generally
relate to the information and authorities, compliance assurances,
procedural requirements, and control measures that constitute the
``infrastructure'' of a state's air quality management program. These
infrastructure SIP elements required by section 110(a)(2) are as
follows:
     Section 110(a)(2)(A): Emission limits and other control
measures.
     Section 110(a)(2)(B): Ambient air quality monitoring/data
system.
     Section 110(a)(2)(C): Program for enforcement of control
measures and regulation of new and modified stationary sources.
     Section 110(a)(2)(D)(i): Interstate pollution transport.
     Section 110(a)(2)(D)(ii): Interstate and international
pollution abatement.
     Section 110(a)(2)(E): Adequate resources and authority,
conflict of interest, and oversight of local and regional government
agencies.
     Section 110(a)(2)(F): Stationary source monitoring and
reporting.
     Section 110(a)(2)(G): Emergency episodes.
     Section 110(a)(2)(H): SIP revisions.
     Section 110(a)(2)(J): Consultation with government
officials, public notification, prevention of significant deterioration
(PSD), and visibility protection.
     Section 110(a)(2)(K): Air quality modeling and submittal
of modeling data.
     Section 110(a)(2)(L): Permitting fees.
     Section 110(a)(2)(M): Consultation/participation by
affected local entities.
    Two elements identified in section 110(a)(2) are not governed by
the three-year submittal deadline of section 110(a)(1) and are
therefore not addressed in this action. These two elements are: (i)
Section 110(a)(2)(C) to the extent it refers to permit programs
required under part D (nonattainment new source review (NSR)), and (ii)
section 110(a)(2)(I), pertaining to the nonattainment planning
requirements of part D. As a result, this action does not address
infrastructure for the nonattainment NSR portion of section
110(a)(2)(C) or the whole of section 110(a)(2)(I).
    On November 12, 2008, the EPA issued a revised NAAQS for Pb.\1\
This action triggered a requirement for states to submit an
infrastructure SIP to address the applicable requirements of section
110(a)(2) within three years of issuance of the revised NAAQS. On
October 14, 2011, EPA issued ``Guidance on Section 110 Infrastructure
SIPs for the 2008 Pb NAAQS'', referred to herein as EPA's 2011 Pb
Guidance.\2\ Depending on the timing of a given submittal, some states
relied on the earlier draft version of this guidance, referred to
herein as EPA's 2011 Draft Pb Guidance.\3\ EPA issued additional
guidance on infrastructure SIPs on September 13, 2013.\4\
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    \1\ 73 FR 66964 (November 12, 2008). The 1978 Pb standard (1.5
[micro]g/m\3\ as a quarterly average) was modified to a rolling 3
month average not to be exceeded of 0.15 [micro]g/m\3\. EPA also
revised the secondary NAAQS to 0.15 [micro]g/m\3\ and made it
identical to the revised primary standard. Id.
    \2\ See Memorandum from Stephen D. Page, Director, Office of Air
Quality Planning and Standards, to Regional Air Division Directors,
Regions 1-10 (October 14, 2011).
    \3\ ``DRAFT Guidance on SIP Elements Required Under Sections
110(a)(1) and (2) for the 2008 Lead (Pb) National Ambient Air
Quality Standards (NAAQS),'' June 17, 2011 version.
    \4\ See Memorandum dated September 13, 2013 from Stephen D.
Page, Director, EPA Office of Air Quality Planning and Standards, to
Regional Air Directors, EPA Regions 1-10, ``Guidance on
Infrastructure State Implementation Plan (SIP) Elements under Clean
Air Act Sections 110(a)(1) and 110(a)(2)'' (referred to herein as
``2013 Infrastructure SIP Guidance'').
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    On March 27, 2008, EPA issued a revised NAAQS for 8-hour Ozone.\5\
This action triggered a requirement for states to submit an
infrastructure SIP to address the applicable requirements of section
110(a)(2) within three years of issuance of the revised NAAQS. EPA did
not, however, prepare guidance at this time for states in submitting I-
SIP revisions for the 2008 Ozone NAAQS.\6\ On September 13, 2013, EPA
issued ``Guidance of Infrastructure State Implementation Plan (SIP)
Elements under Clean Air Act Sections 110(a)(1) and 110(a)(2),'' which
provides advice on the development of infrastructure SIPs for the 2008
ozone NAAQS (among other pollutants) as well as infrastructure SIPs for
new or revised NAAQS promulgated in the future.\7\
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    \5\ 73 FR 16436 (March 27, 2008).
    \6\ Preparation of guidance for the 2008 Ozone NAAQS was
postponed given EPA's reconsideration of the standard. See 78 FR
34183 (June 6, 2013).
    \7\ See Memorandum dated September 13, 2013 from Stephen D.
Page, Director, EPA Office of Air Quality Planning and Standards, to
Regional Air Directors, EPA Regions 1-10, ``Guidance on
Infrastructure State Implementation Plan (SIP) Elements under Clean
Air Act Sections 110(a)(1) and 110(a)(2)'' (referred to herein as
``2013 Infrastructure SIP Guidance'').
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    The Arizona Department of Environmental Quality (ADEQ) has
submitted infrastructure SIP revisions pursuant to EPA's promulgation
of the NAAQS addressed by this rule, including the following:

     October 14, 2011--``Arizona State Implementation Plan
Revision under Clean Air Act Section 110(a)(1) and (2); 2008 Lead
NAAQS,'' to address all of the CAA section 110(a)(2) requirements,
except for section 110(a)(2)(G),\8\ for the 2008 Pb NAAQS (2011 Pb I-
SIP Submittal).
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    \8\ In a separate rulemaking, EPA fully approved Arizona's SIP
to address the requirements regarding air pollution emergency
episodes in CAA section 110(a)(2)(G) for the 1997 8-hour ozone
NAAQS. 77 FR 62452 (October 15, 2012). Although ADEQ did not submit
an analysis of Section 110(a)(2)(G) requirements, we discuss them in
our technical support document (TSD), which is in the docket for
this rulemaking.
---------------------------------------------------------------------------

     December 27, 2012--``Arizona State Implementation Plan
Revision under Clean Air Act Section 110(a)(1) and (2); 2008 8-hour
Ozone NAAQS,'' to address all of the CAA section 110(a)(2) requirements
for the 2008 8-hour Ozone NAAQS (2012 Ozone I-SIP Submittal).
    On February 19, 2015 EPA approved elements of the above submittals
with respect to the 2008 Pb and 2008 8-hour ozone NAAQS infrastructure
requirements in CAA sections 110(a)(2)(A), (B), (E), (F), (G), (H), (L)
and (M).\9\ That action also explained that we would separately act on
the permitting infrastructure SIP elements in CAA sections
110(a)(2)(C), (D), (J), and (K) in a subsequent rulemaking. These
permit related elements are the subject of today's final rule.
---------------------------------------------------------------------------

    \9\ ``Approval and Promulgation of State Implementation Plans;
Arizona; Infrastructure requirements for the 2008 Lead (Pb) and the
2008 8-Hour Ozone National Ambient Air Quality Standards (NAAQS)''
was signed on February 19, 2015 but, as of June 29, 2015, has not
yet published in the Federal Register. This action was proposed in
the Federal Register on November 24, 2014 (79 FR 69796).
---------------------------------------------------------------------------

    In addition to the above 2011 and 2012 infrastructure SIP
submittals, ADEQ submitted ``New Source Review State Implementation
Plan Submission'' on October 29, 2012, and ``Supplemental Information
to 2012 New Source Review State Implementation Plan Submission'' on
July 2, 2014 (NSR Submittals). In addition to addressing revisions to
Arizona's NSR program, these submissions also relate to our analysis of
infrastructure SIP elements in CAA sections 110(a)(2)(C), (D), (J), and
(K).

II. Proposed Action

    On May 12, 2015 (80 FR 27127), EPA proposed to partially approve
and partially disapprove Arizona's 2011 Pb I-SIP Submittal and 2012
Ozone I-SIP Submittal with respect to the permitting infrastructure SIP
elements in CAA sections 110(a)(2)(C), (D), (J), and (K). Our proposed
action and associated technical support document (TSD) provide detailed
discussion of Arizona's demonstration for each element. Generally, we
proposed a partial approval because the submittals show that Arizona
largely fulfills the relevant infrastructure requirements. But we
proposed a simultaneous partial disapproval because of these
deficiencies:
     With respect to Sec.  110(a)(2)(C), EPA proposed to: (1)
Disapprove the 2011 Pb and 2012 Ozone Infrastructure SIPs for ADEQ and
Pinal County because the SIP-approved PSD programs lack certain
``structural'' PSD program elements as identified in our TSD; and (2)
disapprove both Infrastructure SIPs for Maricopa and Pima counties,
which do not have SIP approved PSD programs.
     With respect to the third prong of Sec.  110(a)(D)(i), EPA
proposed to disapprove both Infrastructure SIPs regarding
``structural'' PSD requirements under Sec.  110(a)(2)(C).
     With respect to Sec.  110(a)(2)(D)(ii), EPA proposed to
disapprove both Infrastructure SIPs with respect to Maricopa County and
Pima County, which do not have SIP approved PSD programs.
     With respect to Sec.  110(a)(2)(J), we proposed to
disapprove both Arizona Infrastructure SIPs for failure to fully
satisfy the requirements of part C relating to PSD.
     With respect to Sec.  110(a)(2)(K), we proposed to
disapprove both Infrastructure SIPs because ADEQ, Pinal, Pima, and
Maricopa counties have not submitted adequate provisions or a narrative
that explain how existing state and county law satisfy the requirements
of 110(a)(2)(K).

III. Public Comments and EPA Responses

    The public comment period on EPA's proposed rule opened on May 12,
2015, the date of its publication in the Federal Register at 80 FR
27127, and closed on June 11, 2015. During this period, EPA did not
receive any comments. Therefore, EPA is finalizing our action as
proposed.

IV. Final Action

    Under CAA section 110(k)(3) and based on the evaluation and
rationale presented in the proposed rule, the TSD and this final rule,
EPA is partially approving the 2011 Pb I-SIP Submittal and the 2012
Ozone I-SIP Submittal with respect to the following infrastructure SIP
requirements:
     Section 110(a)(2)(C) (in part): Program of enforcement of
control measures and regulation of new and modified stationary sources.
     Section 110(a)(2)(D)(i) (in part): Interstate pollution
transport.
     Section 110(a)(2)(D)(ii) (in part): Interstate pollution
abatement and international air pollution.
     Section 110(a)(2)(J) (in part): Consultation with
government officials, public notification, PSD, and visibility
protection.
     Section 110(a)(2)(K): Air quality modeling and submission
of modeling data.
    EPA is simultaneously partially disapproving the submittals because
of deficiencies described in our proposed rule and TSD and summarized
in the proposed rule section above. For all I-SIP elements that do not
meet the CAA Sec.  110(a)(2) requirements there are existing FIPs in
place, with the exception of the modeling requirements under CAA Sec.
110(a)(2)(K) for Pinal County and ADEQ. To the extent our proposed
approval or proposed disapproval of an I-SIP element relied on our
March 18, 2015 proposed action on ADEQ's NSR SIP submittal, our final
action on the I-SIP elements identified in this notice relies on our
final action on ADEQ's NSR SIP submittal, signed contemporaneously
primarily in the form of a limited approval/limited disapproval.\10\
Furthermore, the partial disapprovals in this action do not result in
sanctions under section 179 of the Act because infrastructure SIPs are
not required under Title I, Part D of the Act.
---------------------------------------------------------------------------

    \10\ EPA's action on ADEQ's NSR SIP submittal was largely
finalized as proposed, with the exception of certain changes in
response to public comments. These changes resulted in our finding
fewer bases for disapproval as compared with our proposed action on
ADEQ's NSR SIP submittal and do not affect today's final action on
Arizona's I-SIP submittals.
---------------------------------------------------------------------------

V. Statutory and Executive Order Reviews

A. Executive Order 12866, Regulatory Planning and Review

    The Office of Management and Budget (OMB) has exempted this
regulatory action from Executive Order 12866, entitled ``Regulatory
Planning and Review.''

B. Paperwork Reduction Act

    This action does not impose an information collection burden under
the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq.
Burden is defined at 5 CFR 1320.3(b).

C. Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA) generally requires an agency
to conduct a regulatory flexibility analysis of any rule subject to
notice and comment rulemaking requirements 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 not-for-profit enterprises, and small
governmental jurisdictions.
    This rule will not have a significant impact on a substantial
number of small entities because SIP partial approvals/partial
disapprovals under section 110 and subchapter I, part D of the Clean
Air Act do not create any new requirements but simply approve
requirements that the State is already imposing. Therefore, because
EPA's approval does not create any new requirements, I certify that
this action will not have a significant economic impact on a
substantial number of small entities.
    Moreover, due to the nature of the Federal-State relationship under
the Clean Air Act, preparation of flexibility analysis would constitute
Federal inquiry into the economic reasonableness of State action. The
Clean Air Act forbids EPA to base its actions concerning SIPs on such
grounds. Union Electric Co., v. U.S. EPA, 427 U.S. 246, 255-66 (1976);
42 U.S.C. 7410(a)(2).

D. Unfunded Mandates Reform Act

    Under sections 202 of the Unfunded Mandates Reform Act of 1995
(``Unfunded Mandates Act''), signed into law on March 22, 1995, EPA
must prepare a budgetary impact statement to accompany any proposed or
final rule that includes a Federal mandate that may result in estimated
costs to State, local, or tribal governments in the aggregate; or to
the private sector, of $100 million or more. Under section 205, EPA
must select the most cost-effective and least burdensome alternative
that achieves the objectives of the rule and is consistent with
statutory requirements. Section 203 requires EPA to establish a plan
for informing and advising any small governments that may be
significantly or uniquely impacted by the rule.
    EPA has determined that the partial approval/partial disapproval
action promulgated does not include a Federal mandate that may result
in estimated costs of $100 million or more to either State, local, or
tribal governments in the aggregate, or to the private sector. This
Federal action approves pre-existing requirements under State or local
law, and imposes no new requirements. Accordingly, no additional costs
to State, local, or tribal governments, or to the private sector,
result from this action.

E. Executive Order 13132, Federalism

    Federalism (64 FR 43255, August 10, 1999) revokes and replaces
Executive Orders 12612 (Federalism) and 12875 (Enhancing the
Intergovernmental Partnership). Executive Order 13132 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.'' Under Executive Order 13132, EPA may not issue a
regulation that has federalism implications, that imposes substantial
direct compliance costs, and that is not required by statute, unless
the Federal government provides the funds necessary to pay the direct
compliance costs incurred by State and local governments, or EPA
consults with State and local officials early in the process of
developing the proposed regulation. EPA also may not issue a regulation
that has federalism implications and that preempts State law unless the
Agency consults with State and local officials early in the process of
developing the proposed regulation.
    This rule 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, because it
merely approves a State rule implementing a Federal standard, and does
not alter the relationship or the distribution of power and
responsibilities established in the Clean Air Act. Thus, the
requirements of section 6 of the Executive Order do not apply to this
rule.

F. Executive Order 13175, Coordination With Indian Tribal Governments

    Executive Order 13175, entitled ``Consultation and Coordination
with Indian Tribal Governments'' (65 FR 67249, November 9, 2000),
requires the 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 final rule
does not have tribal implications, as specified in Executive Order
13175. It will not have substantial direct effects on tribal
governments, 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. In addition, 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 and will not impose substantial direct costs on
tribal governments or preempt tribal law. Thus, Executive Order 13175
does not apply to this rule.

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

    EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997)
as applying only to those regulatory actions that concern health or
safety risks, such that the analysis required under section 5-501 of
the Executive Order has the potential to influence the regulation. This
rule is not subject to Executive Order 13045, because it approves a
State rule implementing a Federal standard.

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

    This 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 and Advancement Act

    Section 12 of the National Technology Transfer and Advancement Act
(NTTAA) of 1995 requires Federal agencies to evaluate existing
technical standards when developing a new regulation. To comply with
NTTAA, EPA must consider and use ``voluntary consensus standards''
(VCS) if available and applicable when developing programs and policies
unless doing so would be inconsistent with applicable law or otherwise
impractical.
    The EPA believes that VCS are inapplicable to this action. Today's
action does not require the public to perform activities conducive to
the use of VCS.

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

    Executive Order (E.O.) 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 lacks the discretionary authority to address environmental
justice in this rulemaking.

K. Congressional Review 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 this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2). This rule will be effective August 13, 2015.

L. Petitions for Judicial Review

    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by September 14, 2015. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this rule for the purposes of judicial
review nor does it extend the time within which a petition for judicial
review may be filed, and shall not postpone the effectiveness of such
rule or action. This action may not be challenged later in proceedings
to enforce its requirements (see section 307(b)(2)).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Ozone, Lead, Reporting and
recordkeeping requirements.

    Dated: June 29, 2015.
Jared Blumenfeld,
Regional Administrator, Region IX.

    Part 52, Chapter I, Title 40 of the Code of Federal Regulations is
amended 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 D--Arizona

0
2. Section 52.123 is amended by adding paragraphs (o) and (p) to read
as follows:

Sec.  52.123  Approval status.

* * * * *
    (o) 2008 8-hour ozone NAAQS: The SIPs submitted on October 14, 2011
and December 27, 2012 are fully or partially disapproved for Clean Air
Act (CAA) elements 110(a)(2)(C), (D)(ii), (J) and (K) for all portions
of the Arizona SIP.
    (p) 2008 Lead (Pb) NAAQS: The SIPs submitted on October 14, 2011
and December 27, 2012 are fully or partially disapproved for Clean Air
Act (CAA) elements 110(a)(2)(C), (D)(ii), (J) and (K) for all portions
of the Arizona SIP.

[FR Doc. 2015-17057 Filed 7-13-15; 8:45 am]
 BILLING CODE 6560-50-P