[Federal Register Volume 76, Number 136 (Friday, July 15, 2011)]
[Rules and Regulations]
[Page 41693]
[FR Doc No: 2011-17798]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[USCG-2010-0577]
RIN 1625-AA00

Safety Zone; Annual Events Requiring Safety Zones in Milwaukee
Harbor, Milwaukee, WI

AGENCY: Coast Guard, DHS.

ACTION: Notice of enforcement of regulation.

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SUMMARY: The Coast Guard will enforce this safety zone for annual
fireworks events in the Captain of the Port Sector Lake Michigan zone
at various times from 10 p.m. on July 21, 2011 through 11 p.m. on July
30, 2011 and then again from 10:15 p.m. through 11 p.m. on August 21,
2011. This action is necessary and intended to ensure safety of life on
the navigable waters immediately prior to, during, and immediately
after fireworks events. During the aforementioned periods, the Coast
Guard will enforce restrictions upon, and control movement of, vessels
in a specified. During the enforcement period, no person or vessel may
enter these safety zones without permission of the Captain of the Port,
Sector Lake Michigan.

DATES: The regulations in 33 CFR 165.935 will be enforced at various
times between 10 p.m. on July 21, 2011 and 11 p.m. on July 30, 2011 and
then again between 10:15 p.m. and 11 p.m. on August 21, 2011.

FOR FURTHER INFORMATION CONTACT: If you have questions on this notice,
call or e-mail BM1 Adam Kraft, Prevention Department, Coast Guard
Sector Lake Michigan, Milwaukee, WI at<PHONE_NUMBER>, e-mail
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATON: The Coast Guard will enforce the safety zone
listed in 33 CFR 165.935, Safety Zones, Milwaukee Harbor, Milwaukee,
WI, for the following events:
    (1) Festa Italiana fireworks display on July 21, 2011 from 10 p.m.
through 10:45 p.m.; on July 22, 2011 from 10 p.m. through 10:45 p.m.;
on July 23, 2011 from 10 p.m. through 10:45 p.m.; on July 24, 2010 from
10 p.m. through 10:45 p.m.
    (2) German Festival fireworks display on July 29, 2011 from 9:45
p.m. through 10:30 p.m.; on July 30, 2011 from 10:15 p.m. through 11
p.m.
    (3) Irish Festival fireworks display on August 21, 2011 from 10:15
p.m. through 11 p.m.
    All vessels must obtain permission from the Captain of the Port,
Sector Lake Michigan, or his or her on-scene representative to enter,
move within, or exit a safety zone. Vessels and persons granted
permission to enter the safety zone shall obey all lawful orders or
directions of the Captain of the Port, Sector Lake Michigan, or a
designated representative. While within a safety zone, all vessels
shall operate at the minimum speed necessary to maintain a safe course.
    This notice is issued under authority of 33 CFR 165.935 Safety
Zone, Milwaukee Harbor, Milwaukee, WI and 5 U.S.C. 552(a). In addition
to this notice in the Federal Register, the Coast Guard will provide
the maritime community with advance notification of these enforcement
periods via Broadcast Notice to Mariners or Local Notice to Mariners.
The Captain of the Port, Sector Lake Michigan will issue a Broadcast
Notice to Mariners notifying the public when enforcement of the safety
zone established by this section is suspended. If the Captain of the
Port, Sector Lake Michigan, determines that the safety zone need not be
enforced for the full duration stated in this notice, he or she may use
a Broadcast Notice to Mariners to grant general permission to enter the
safety zone. The Captain of the Port, Sector Lake Michigan, or his or
her on-scene representative may be contacted via VHF Channel 16.

    Dated: June 29, 2011.
M.W. Sibley,
Captain, U.S. Coast Guard, Captain of the Port, Sector Lake Michigan.
[FR Doc. 2011-17798 Filed 7-14-11; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 78, Number 211 (Thursday, October 31, 2013)]
[Notices]
[Pages 65419-65420]
[FR Doc No: 2013-25826]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Approval of Noise Compatibility Program for Tucson International
Airport, Tucson, Arizona

AGENCY: Federal Aviation Administration, DOT.

ACTION: Notice.

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SUMMARY: The Federal Aviation Administration (FAA) announces its
findings on the noise compatibility program submitted by the Tucson
Airport Authority (TAA) under the provisions of 49 U.S.C. 47501 et seq.
(formerly the Aviation Safety and Noise Abatement Act, hereinafter
referred to as ``the Act'') and 14 Code of Federal Regulations (CFR)
Part 150 (hereinafter referred to as ``Part 150''). On March 20, 2013,
the FAA determined that the noise exposure maps submitted by the TAA
under Part 150 were in compliance with applicable requirements. On
September 9, 2013, the FAA approved the Tucson International Airport
noise compatibility program. Most of the recommendations of the program
were approved. No program elements relating to new or revised flight
procedures for noise abatement were proposed.

DATED: Effective Date: This notice is effective October 31, 2013 and
applicable September 9, 2013.

FOR FURTHER INFORMATION CONTACT: Jared Raymond, Airport Planner, FAA
Phoenix Airports Field Office, 2800 North 44th Street, Phoenix, Arizona
85008, telephone number<PHONE_NUMBER>. Documents reflecting this FAA
action may be reviewed at this same location.

SUPPLEMENTARY INFORMATION: This notice announces that the FAA has given
its overall approval to the Noise Compatibility Program for Tucson
International Airport, effective September 9, 2013. Under section
104(a) of the Aviation Safety and Noise Abatement Act of 1979, as
amended (herein after referred to as the ``Act'') [recodified as 49
U.S.C. 47504], an airport operator who has previously submitted a Noise
Exposure Map may submit to the FAA a Noise Compatibility Program which
sets forth the measures taken or proposed by the airport operator for
the reduction of existing non-compatible land uses and prevention of
additional non-compatible land uses within the area covered by the
Noise Exposure Maps. The Act requires such programs to be developed in
consultation with interested and affected parties including local
communities, government agencies, airport users, and FAA personnel.
    Each airport noise compatibility program developed in accordance
with Federal Aviation Regulations (FAR) Part 150 is a local program,
not a Federal program. The FAA does not substitute its judgment for
that of the airport proprietor with respect to which measures should be
recommended for action. The FAA's approval or disapproval of FAR Part
150 program recommendations is measured according to the standards
expressed in Part 150 and the Act, and is limited to the following
determinations:
    a. The Noise Compatibility Program was developed in accordance with
the provisions and procedures of FAR Part 150;
    b. Program measures are reasonably consistent with achieving the
goals of reducing existing non-compatible land uses around the airport
and preventing the introduction of additional non-compatible land uses;
    c. Program measures would not create an undue burden on interstate
or foreign commerce, unjustly discriminate against types or classes of
aeronautical uses, violate the terms of airport grant agreements, or
intrude into areas preempted by the Federal Government; and
    d. Program measures relating to the use of flight procedures can be
implemented within the period covered by the program without derogating
safety, adversely affecting the efficient use and management of the
navigable airspace and air traffic control systems, or adversely
affecting other powers and responsibilities of the Administrator
prescribed by law.
    Specific limitations with respect to FAA's approval of an airport
noise compatibility program are delineated in FAR Part 150, section
150.5. Approval is not a determination concerning the acceptability of
land uses under Federal, state, or local law. Approval does not by
itself constitute an FAA implementing action. A request for Federal
action or approval to implement specific noise compatibility measures
may be required, and an FAA decision on the request may require an
environmental assessment of the proposed action. Approval does not
constitute a commitment by the FAA to financially assist in the
implementation of the program nor a determination that all measures
covered by the program are eligible for grant-in-aid funding from the
FAA under the Airport and Airway Improvement Act of 1982, as amended.
Where federal funding is sought, requests for project grants must be
submitted to the FAA Airports Field Office in Phoenix, Arizona.
    The TAA submitted to the FAA on November 26, 2013, the Noise
Exposure Maps for evaluation. The FAA determined that the Noise
Exposure Maps for Tucson International Airport were in compliance with
applicable requirements on March 20, 2013. Notice of this determination
was published in the Federal Register on March 29, 2013 (Volume 78/No.
61/pages 19355-19356).
    The Tucson International Airport study contains a proposed noise
compatibility program comprised of actions designed for phased
implementation by airport management and adjacent jurisdictions. It was
requested that the FAA evaluate and approve this material as a Noise
Compatibility Program as described in 49 U.S.C. 47504 (formerly Section
104(b) of the Act). The FAA began its review of the program on March
20,

2013, and was required by a provision of the Act to approve or
disapprove the program within 180 days (other than the use of new or
modified flight procedures for noise control). Failure to approve or
disapprove such program within the 180-day period shall be deemed to be
an approval of such program.
    The Noise Compatibility Program recommended three Noise Abatement
Elements, five Land Use Planning Elements and two Program Management
Elements. The FAA completed its review and determined that the
procedural and substantive requirements of the Act and FAR Part 150
have been satisfied. The overall program was approved, by the Manager
of the Airports Division, Western-Pacific Region, effective September
9, 2013.
    Approval was granted for four Land Use Planning Elements and one
Program Management Element. The approved measures include: Working with
the City of Tucson to review and if necessary modify the boundaries of
the Airport Environs Zone (AEZ) Overlay; work with the City of Tucson
to review and if necessary modify the land use regulations within the
AEZ Overlay as defined in Section 2.8.5 of the City of Tucson Land Use
Code; Work with Pima County to review and if necessary modify the
boundaries of the Airport Environs and facilities Overlay Zone (AEFZ);
work with Pima County to review and if necessary modify the land use
regulations within the AEFZ Overlay as defined in Pima County Code; and
periodically review and if necessary, update the Noise Exposure Maps
(NEM'S) and the Noise Compatibility Program (NCP). Approval as a
voluntary measure was given for two Noise Abatement Elements and one
Program Management Element. These measures include: Formalizing an
agreement with the Arizona Air National Guard (AANG) to limit
nighttime/early morning and weekend operations; work with the AANG to
develop restrictions on ground operations, including optimal
orientation of aircraft during final checks prior to departure to
reduce noise impacts, and formalize and expand current public outreach
programs. One Noise Abatement Element and one Land Use Planning Element
was disapproved for purposes of Part 150, since they did not reduce
incompatible land uses or lacked a demonstrated noise benefit to
noncompatible land uses exposed to noise levels in the yearly day/night
average sound level (DNL) 65 noise contours. These measures included:
Study implementing an Optimized Profile Descent (OPD) procedure for one
or more runway ends and to investigate opportunities to design Airport
development in a manner that both reduces interior noise levels of the
development and that acts as a barrier to shield neighboring
communities from aircraft noise.
    The FAA determinations are set forth in detail in the Record of
Approval signed by the Manager of the Airports Division, Western-
Pacific Region, on September 9, 2013. The Record of Approval, as well
as other evaluation materials and the documents comprising the
submittal, are available for review at the FAA office listed above and
at the administrative offices of the Tucson International Airport. The
Record of Approval also will be available on-line at: http://www.faa.gov/airports/environmental/airport_noise/part_150/states/.

    Issued in Hawthorne, California, on October 23, 2013.
Brian Q. Armstrong,
Acting Manager, Airports Division, Western-Pacific Region, AWP-600.
[FR Doc. 2013-25826 Filed 10-30-13; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 76, Number 91 (Wednesday, May 11, 2011)]
[Rules and Regulations]
[Pages 27244-27246]
[FR Doc No: 2011-10692]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2010-0706; Directorate Identifier 2010-NM-064-AD;
Amendment 39-16683; AD 2011-10-02]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Model 747-400, 747-
400D, and 747-400F Series Airplanes Equipped With General Electric CF6-
80C2 or Pratt & Whitney PW4000 Series Engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: We are adopting a new airworthiness directive (AD) for the
products listed above. This AD requires modifying certain thrust
reverser control system wiring to the flap control unit (FCU). This AD
was prompted by a report of automatic retraction of the leading edge
flaps due to indications transmitted to the FCU from the thrust
reverser control system during takeoff. We are issuing this AD to
prevent automatic retraction of the leading edge flaps during takeoff,
which could result in reduced climb performance and consequent
collision with terrain and obstacles or forced landing of the airplane.

DATES: This AD is effective June 15, 2011.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in the AD as of June 15, 2011.

ADDRESSES: For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
P.O. Box 3707, MC 2H-65, Seattle, Washington 98124-2207; telephone 206-
544-5000, extension 1; fax<PHONE_NUMBER>; e-mail<EMAIL_ADDRESS>
Internet https:[sol][sol]www.myboeingfleet.com. You may review copies
of the referenced service information at the FAA, Transport Airplane
Directorate, 1601 Lind Avenue, SW., Renton, Washington. For information
on the availability of this material at the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at
http:[sol][sol]www.regulations.gov; or in person at the Docket
Management Facility between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The AD docket contains this AD, the regulatory
evaluation, any comments received, and other information. The address
for the Docket Office (phone:<PHONE_NUMBER>) is Document Management
Facility, U.S. Department of Transportation, Docket Operations, M-30,
West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE.,
Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Tung Tran, Aerospace Engineer,
Propulsion Branch, ANM-140S, FAA, Seattle Aircraft Certification
Office, 1601 Lind Avenue, SW., Renton, Washington 98057-3356; phone:
425-917-6505; fax<PHONE_NUMBER>; e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to include an airworthiness directive (AD) that would apply to
the

specified products. That NPRM published in the Federal Register on
August 5, 2010 (75 FR 47245). That NPRM proposed to require modifying
certain thrust reverser control system wiring to the flap control unit
(FCU).

Comments

    We gave the public the opportunity to participate in developing
this AD. The following presents the comments received on the proposal
and the FAA's response to each comment.

Support for the NPRM

    Boeing, Airline Pilots Association, International (ALPA), and Japan
Airlines International (JAL) support the intent of the NPRM.

Requests To Use Latest Service Information

    JAL and All Nippon Airways (ANA) requested that we update the NPRM
to reference Boeing Special Attention Service Bulletin 747-78-2183,
Revision 1, dated December 23, 2010. The commenters stated that Boeing
has issued Boeing Service Bulletin Information Notice 747-78-2183 IN
01, dated May 6, 2010, to correct the operational test procedure. The
NPRM referred to Boeing Special Attention Service Bulletin 747-78-2183,
dated January 12, 2010.
    We agree to reference the latest service information and have
changed paragraph (h) of this AD to reference Boeing Special Attention
Service Bulletin 747-78-2183, Revision 1, dated December 23, 2010. We
have also changed paragraph (g) of this AD to reference Boeing Alert
Service Bulletin 747-78A2184, Revision 1, dated December 23, 2010,
which was also revised (the NPRM referred to Boeing Alert Service
Bulletin 747-78A2184, dated January 12, 2010). Changes to these service
bulletins include changes to the functional test tasks to better
describe the use of pneumatic and electrical power, and to provide a
better sequence of test tasks.
    We have also added paragraph (i) to this AD to give credit to
operators for accomplishing the actions specified in Boeing Special
Attention Service Bulletin 747-78-2183 and Boeing Alert Service
Bulletin 747-78A2184, both dated January 12, 2010. We have re-
identified subsequent paragraphs accordingly.

Conclusion

    We reviewed the relevant data, considered the comments received,
and determined that air safety and the public interest require adopting
the AD with the changes described previously--and minor editorial
changes. We have determined that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM for correcting the unsafe condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM.
    We also determined that these changes will not increase the
economic burden on any operator or increase the scope of the AD.

Costs of Compliance

    We estimate that this AD affects 98 airplanes of U.S. registry. We
estimate that it will take 1 work-hour per product to comply with this
AD. The average labor rate is $85 per work-hour. Required parts would
cost $0 per product. Based on these figures, we estimate the cost of
this AD to the U.S. operators to be $8,330, or $85 per product.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    We are issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

2011-10-02 The Boeing Company: Amendment 39-16683; Docket No. FAA-
2010-0706; Directorate Identifier 2010-NM-064-AD.

Effective Date

    (a) This AD is effective June 15, 2011.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to The Boeing Company Model 747-400, 747-
400D, and 747-400F series airplanes; certificated in any category;
equipped with General Electric CF6-80C2 series engines or Pratt &
Whitney PW4000 series engines, as applicable.

Subject

    (d) Air Transport Association (ATA) of America Code 78: Engine
exhaust.

Unsafe Condition

    (e) This AD was prompted by a report of automatic retraction of
the leading edge flaps due to indications transmitted to the flap
control unit (FCU) from the thrust reverser control system during
takeoff. The Federal Aviation Administration is issuing this AD to
prevent automatic retraction of the leading edge flaps during
takeoff, which could result in reduced climb performance and
consequent collision with terrain and obstacles or forced landing of
the airplane.

Compliance

    (f) You are responsible for having the actions required by this
AD performed within the compliance times specified, unless the
actions have already been done.

Modification

    (g) For Model 747-400 and -400F airplanes equipped with Pratt &
Whitney Model PW4000 series engines: Within 36 months

after the effective date of this AD, modify the thrust reverser
control system wiring to the FCU in the P252 and P253 thrust
reverser relay panels, in accordance with the Accomplishment
Instructions of Boeing Alert Service Bulletin 747-78A2184, Revision
1, dated December 23, 2010.
    (h) For Model 747-400, -400D, and -400F airplanes equipped with
General Electric Model CF6-80C2 series engines: Within 36 months
after the effective date of this AD, modify the thrust reverser
control system wiring to the FCU in the P414 and P415 power
distribution panels, in accordance with Boeing Special Attention
Service Bulletin 747-78-2183, Revision 1, dated December 23, 2010.

Credit for Actions Accomplished in Accordance With Previous Service
Information

    (i) Modifying the thrust reverser control system wiring before
the effective date of this AD, in accordance with Boeing Special
Attention Service Bulletin 747-78-2183 or Boeing Alert Service
Bulletin 747-78A2184, both dated January 12, 2010, as applicable, is
acceptable for compliance with the corresponding modification
required by paragraph (g) or (h) of this AD.

Alternative Methods of Compliance (AMOCs)

    (j)(1) The Manager, Seattle Aircraft Certification Office (ACO),
FAA, has the authority to approve AMOCs for this AD, if requested
using the procedures found in 14 CFR 39.19. In accordance with 14
CFR 39.19, send your request to your principal inspector or local
Flight Standards District Office, as appropriate. If sending
information directly to the manager of the ACO, send it to the
attention of the person identified in the Related Information
section of this AD. Information may be e-mailed to<EMAIL_ADDRESS>    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.

Related Information

    (k) For more information about this AD, contact Tung Tran,
Aerospace Engineer, Propulsion Branch, ANM-140S, FAA, Seattle
Aircraft Certification Office, 1601 Lind Avenue, SW., Renton,
Washington 98057-3356; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; e-
mail<EMAIL_ADDRESS>    (l) For information about AMOCs, contact Tung Tran, Aerospace
Engineer, Propulsion Branch, ANM-140S, FAA, Seattle Aircraft
Certification Office, 1601 Lind Avenue, SW., Renton, Washington
98057-3356; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; e-mail:
<EMAIL_ADDRESS>
Material Incorporated by Reference

    (m) You must use Boeing Special Attention Service Bulletin 747-
78-2183, Revision 1, dated December 23, 2010; or Boeing Alert
Service Bulletin 747-78A2184, Revision 1, dated December 23, 2010;
as applicable; to do the actions required by this AD, unless the AD
specifies otherwise.
    (1) The Director of the Federal Register approved the
incorporation by reference of the service information under 5 U.S.C.
552(a) and 1 CFR part 51.
    (2) For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
P.O. Box 3707, MC 2H-65, Seattle, Washington 98124-2207; telephone
206-544-5000, extension 1; fax<PHONE_NUMBER>; e-mail
<EMAIL_ADDRESS>Internet https://www.myboeingfleet.com.
    (3) You may review copies of the service information at the FAA,
Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton,
Washington. For information on the availability of this material at
the FAA, call<PHONE_NUMBER>.
    (4) You may also review copies of the service information that
is incorporated by reference at the National Archives and Records
Administration (NARA). For information on the availability of this
material at an NARA facility, call<PHONE_NUMBER>, or go to http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

    Issued in Renton, Washington, on April 20, 2011.
Kalene C. Yanamura,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2011-10692 Filed 5-10-11; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 87, Number 242 (Monday, December 19, 2022)]
[Notices]
[Pages 77619-77620]
[FR Doc No: 2022-27415]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-1998-D-0038]

Evaluating the Safety of Antimicrobial New Animal Drugs With
Regard to Their Microbiological Effects on Bacteria of Human Health
Concern; Revised Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry #152 entitled
``Evaluating the Safety of Antimicrobial New Animal Drugs with Regard
to Their Microbiological Effects on Bacteria of Human Health Concern.''
This draft guidance informs stakeholders about FDA's current method for
evaluating potential microbiological effects of antimicrobial new
animal drugs on bacteria of human health concern as part of the new
animal drug application process.

DATES: Submit either electronic or written comments on the draft
guidance by March 20, 2023 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time 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-1998-D-0038 for ``Evaluating the Safety of Antimicrobial New Animal
Drugs with Regard to Their Microbiological Effects on Bacteria of Human
Health Concern.'' Received comments 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.'' The Agency 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 to 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 this 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>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the guidance to the
Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine,
Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855.
Send one self-addressed adhesive label to assist that office in
processing your requests. See the SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Ruby Singh, Center for Veterinary
Medicine (HFV-150), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855,<PHONE_NUMBER>, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
#152 entitled ``Evaluating the Safety of Antimicrobial New Animal Drugs
with Regard to their Microbiological Effects on Bacteria of Human
Health Concern.'' Antimicrobial drugs have been used since the mid-20th
century to control and cure infectious diseases in humans. Since their
discovery, these drugs have prevented millions of human deaths
worldwide, they have helped to promote animal health, and they have
helped to provide an abundant and affordable supply of meat, milk, and
eggs. Soon after antimicrobial drugs became widely available,
scientists noted that their use could contribute to the emergence and
selection of antimicrobial resistance in bacteria, thereby reducing the
effectiveness of the

antimicrobial drugs. To address the human health risks surrounding the
use of antimicrobial new animal drugs, in 2003, FDA issued Guidance for
Industry (GFI) #152, entitled ``Evaluating the Safety of Antimicrobial
New Animal Drugs with Regard to their Microbiological Effects on
Bacteria of Human Health Concern.''
    GFI #152 outlines a qualitative risk assessment methodology as a
process for evaluating foodborne antimicrobial resistance concerns
related to the use of antimicrobial drugs in food-producing animals.
GFI #152 also contains an appendix, commonly referred to as ``Appendix
A,'' in which FDA ranks antimicrobial drugs according to their relative
importance to human medicine: ``critically important,'' ``highly
important,'' or ``important.''
    The current list of medically important antimicrobial drugs in
Appendix A reflects FDA's thinking at the time of publication, in 2003.
It was envisioned at the time of publication of GFI #152 that the
Agency would reassess the rankings provided in Appendix A periodically
to confirm that the rankings are consistent with contemporary practices
and needs. As noted in GFI #152, the development of new antimicrobial
drugs for human therapy, the emergence or re-emergence of diseases in
humans, and changes in prescribing practices, are some factors that may
cause the human medical importance rankings to change over time.
    Given the considerable advances in science that have taken place
since 2003, new relevant information has become available. In light of
those advances and the new information now available, FDA published a
notice in the Federal Register of October 13, 2020 (85 FR 64481),
announcing a public meeting and requesting comments on a concept paper
entitled ``Potential Approach for Ranking of Antimicrobial Drugs
According to Their Importance in Human Medicine: A Risk Management Tool
for Antimicrobial New Animal Drugs.''
    FDA received more than 60 comment submissions from pharmaceutical
companies, academia, organizations, and private citizens on this
concept paper. FDA has considered all comments and is issuing this
draft guidance document, which contains revised sections in the risk
assessment framework, including updated tables and figures, and a
revised Appendix A based on new ranking criteria of antimicrobials
according to their importance in human medicine.
    This level 1 draft guidance is being issued consistent with FDA's
good guidance practices regulation (21 CFR 10.115). The draft guidance,
when finalized, will represent the current thinking of FDA on
``Evaluating the Safety of Antimicrobial New Animal Drugs with Regard
to their Microbiological Effects on Bacteria of Human Health Concern.''
It does not establish any rights for any person and is not binding on
FDA or the public. You can use an alternative approach if it satisfies
the requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR part 514 have been approved under OMB control
number 0910-0032.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at https://www.fda.gov/animal-veterinary/guidance-regulations/guidance-industry, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: December 13, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-27415 Filed 12-16-22; 8:45 am]
BILLING CODE 4164-01-P


Utah--2015 8-Hour Ozone NAAQS
                                             [Primary and Secondary]
----------------------------------------------------------------------------------------------------------------
                                                 Designation                           Classification
       Designated area \1\        ------------------------------------------------------------------------------
                                     Date \2\              Type              Date \2\             Type
----------------------------------------------------------------------------------------------------------------
Northern Wasatch Front, UT.......  ...........  Nonattainment............  ...........  Marginal.
    Weber County (part):
        All portions of Weber
         County west of and
         including Townships 5,
         6, and that portion of 7
         North Range 1 West that
         are west of the
         ridgeline that traces
         the Wasatch Mountains
         from the southeast
         corner of the township
         to the easternmost
         extension of the county
         boundary within the
         township.
    Tooele County (part):
        In Tooele County, the
         following Townships or
         portions thereof as
         noted (including Tooele
         City):
        Township 1 South Range 3
         West.
        Township 2 South Range 3
         West.
        Township 3 South Range 3
         West.
        Township 3 South Range 4
         West.
        Township 2 South Range 4
         West.
        Township 2 South Range 5
         West.
        Township 3 South Range 5
         West.
        Township 3 South Range 6
         West.
        Township 2 South Range 6
         West.
        Township 1 South Range 6
         West.
        Township 1 South Range 5
         West.
        Township 1 South Range 4
         West.
        Township 1 South Range 7
         West.
        Township 2 South Range 7
         West.
        Township 3 South Range 7
         West.
        All Sections within
         Township 4 South Range 7
         West except for Sections
         29, 30, 31 and 32.
        Township 4 South Range 6
         West.
        Township 4 South Range 5
         West.
        Township 4 South Range 4
         West.
        Township 4 South Range 3
         West.
    Salt Lake County.
    Davis County.
Southern Wasatch Front, UT.......  ...........  Nonattainment............  ...........  Marginal.
    Utah County (part):
        All portions of Utah
         County west of and
         including any portion of
         the following townships
         located within Utah
         County:
        Township 3 South Range 1
         East.
        Township 4 South Range 2
         East.
        Township 5 South Range 3
         East.
        Township 6 South Range 3
         East.
        Township 7 South Range 3
         East.
        Township 8 South Range 3
         East.
        Township 9 South Range 3
         East.
        Township 10 South Range 2
         East.
Uinta Basin, UT\3\...............  ...........  Nonattainment............  ...........  Marginal.
    Duchesne County (part):
        All land in Duchesne
         County below a
         contiguous external
         perimeter of 6,250 ft.
         in elevation. All areas
         within that contiguous
         external perimeter are
         included in the
         nonattainment area--
         including mesas and
         buttes which may have an
         elevation greater than
         6,250 ft., but which are
         surrounded on all sides
         by land lower than 6,250
         ft. Additionally, areas
         that fall outside the
         6,250 ft. contiguous
         external perimeter that
         have elevations less
         than 6,250 ft. are
         excluded from the
         nonattainment area. The
         boundary is defined by
         the 6,250 ft. contour
         line created from the
         2013 USGS 10-meter
         seamless Digital
         Elevation Model (USGS
         NED n41w110 \1/3\ arc-
         second 2013 1 x 1 degree
         IMG).
Uintah County (part):
        All land in Uintah County
         below a contiguous
         external perimeter of
         6,250 ft. in elevation.
         All areas within that
         contiguous external
         perimeter are included
         in the nonattainment
         area--including mesas
         and buttes which may
         have an elevation
         greater than 6,250 ft.,
         but which are surrounded
         on all sides by land
         lower than 6,250 ft.
         Additionally, areas that
         fall outside the 6,250
         ft. contiguous external
         perimeter that have
         elevations less than
         6,250 ft. are excluded
         from the nonattainment
         area. The boundary is
         defined by the 6,250 ft.
         contour line created
         from the 2013 USGS 10-
         meter seamless Digital
         Elevation Model (USGS
         NED n41w110 \1/3\ arc-
         second 2013 1 x 1 degree
         IMG).
Beaver County....................      1/16/18  Attainment/Unclassifiable
Box Elder........................  ...........  Attainment/Unclassifiable
Cache County.....................  ...........  Attainment/Unclassifiable
Carbon County....................  ...........  Attainment/Unclassifiable
Daggett County...................  ...........  Attainment/Unclassifiable
Duchesne County (part) remainder.  ...........  Attainment/Unclassifiable
Emery County.....................      1/16/18  Attainment/Unclassifiable

Garfield County..................      1/16/18  Attainment/Unclassifiable
Grand County.....................  ...........  Attainment/Unclassifiable
Iron County......................      1/16/18  Attainment/Unclassifiable
Juab County......................  ...........  Attainment/Unclassifiable
Kane County......................      1/16/18  Attainment/Unclassifiable
Millard County...................      1/16/18  Attainment/Unclassifiable
Morgan County....................  ...........  Attainment/Unclassifiable
Piute County.....................      1/16/18  Attainment/Unclassifiable
Rich County......................  ...........  Attainment/Unclassifiable
San Juan County..................      1/16/18  Attainment/Unclassifiable
Sanpete County...................  ...........  Attainment/Unclassifiable
Sevier County....................      1/16/18  Attainment/Unclassifiable
Summit County....................  ...........  Attainment/Unclassifiable
Tooele County (part) remainder...  ...........  Attainment/Unclassifiable
Uintah County (part) remainder...  ...........  Attainment/Unclassifiable
Utah County (part) remainder.....  ...........  Attainment/Unclassifiable
Wasatch County...................  ...........  Attainment/Unclassifiable
Washington County................      1/16/18  Attainment/Unclassifiable
Wayne County.....................      1/16/18  Attainment/Unclassifiable
Weber County (part) remainder....  ...........  Attainment/Unclassifiable
----------------------------------------------------------------------------------------------------------------
\1\ Includes any Indian country in each county or area, unless otherwise specified. EPA is not determining the
  boundaries of any area of Indian country in this table, including any area of Indian country located in the
  larger designation area. The inclusion of any Indian country in the designation area is not a determination
  that the state has regulatory authority under the Clean Air Act for such Indian country.
\2\ This date is August 3, 2018, unless otherwise noted.
\3\ The EPA is designating portions of the Uinta Basin as ``nonattainment,'' including both Tribal and State
  lands. The Ute Tribe has air quality planning jurisdiction in the areas of Indian country included in the
  Uinta Basin nonattainment area, while the State of Utah has air quality planning jurisdiction in the areas of
  State land included in the Uinta Basin nonattainment area.

* * * * *

0
30. Section 81.347 is amended by revising the table titled ``Virginia--
2015 8-Hour Ozone NAAQS (Primary and Secondary)'' to read as follows:

Sec.  81.347  Virginia.

* * * * *

                                        Virginia--2015 8-Hour Ozone NAAQS
                                             [Primary and Secondary]
----------------------------------------------------------------------------------------------------------------
                                                 Designation                           Classification
       Designated area \1\        ------------------------------------------------------------------------------
                                     Date \2\              Type              Date \2\             Type
----------------------------------------------------------------------------------------------------------------
Washington, DC-MD-VA.............  ...........  Nonattainment............  ...........  Marginal.
    Arlington County.
    Fairfax County.
    Loudoun County.
    Prince William County.
    Alexandria City.
    Fairfax City.
    Falls Church City.
    Manassas City.
    Manassas Park City.
Accomack County..................      1/16/18  Attainment/Unclassifiable
Albemarle County.................      1/16/18  Attainment/Unclassifiable
Alleghany County.................      1/16/18  Attainment/Unclassifiable

Amelia County....................      1/16/18  Attainment/Unclassifiable
Amherst County...................      1/16/18  Attainment/Unclassifiable
Appomattox County................      1/16/18  Attainment/Unclassifiable
Augusta County...................      1/16/18  Attainment/Unclassifiable
Bath County......................      1/16/18  Attainment/Unclassifiable
Bedford County...................      1/16/18  Attainment/Unclassifiable
Bland County.....................      1/16/18  Attainment/Unclassifiable
Botetourt County.................      1/16/18  Attainment/Unclassifiable
Brunswick County.................      1/16/18  Attainment/Unclassifiable
Buchanan County..................      1/16/18  Attainment/Unclassifiable
Buckingham County................      1/16/18  Attainment/Unclassifiable
Campbell County..................      1/16/18  Attainment/Unclassifiable
Caroline County..................      1/16/18  Attainment/Unclassifiable
Carroll County...................      1/16/18  Attainment/Unclassifiable
Charles City County..............      1/16/18  Attainment/Unclassifiable
Charlotte County.................      1/16/18  Attainment/Unclassifiable
Chesterfield County..............      1/16/18  Attainment/Unclassifiable
Clarke County....................  ...........  Attainment/Unclassifiable
Craig County.....................      1/16/18  Attainment/Unclassifiable
Culpeper County..................  ...........  Attainment/Unclassifiable
Cumberland County................      1/16/18  Attainment/Unclassifiable
Dickenson County.................      1/16/18  Attainment/Unclassifiable
Dinwiddie County.................      1/16/18  Attainment/Unclassifiable
Essex County.....................      1/16/18  Attainment/Unclassifiable
Fauquier County..................  ...........  Attainment/Unclassifiable
Floyd County.....................      1/16/18  Attainment/Unclassifiable
Fluvanna County..................      1/16/18  Attainment/Unclassifiable
Franklin County..................      1/16/18  Attainment/Unclassifiable
Frederick County.................  ...........  Attainment/Unclassifiable
Fredericksburg City..............  ...........  Attainment/Unclassifiable
Giles County.....................      1/16/18  Attainment/Unclassifiable
Gloucester County................      1/16/18  Attainment/Unclassifiable
Goochland County.................      1/16/18  Attainment/Unclassifiable
Grayson County...................      1/16/18  Attainment/Unclassifiable
Greene County....................      1/16/18  Attainment/Unclassifiable
Greensville County...............      1/16/18  Attainment/Unclassifiable
Halifax County...................      1/16/18  Attainment/Unclassifiable
Hanover County...................      1/16/18  Attainment/Unclassifiable
Henrico County...................      1/16/18  Attainment/Unclassifiable

Henry County.....................      1/16/18  Attainment/Unclassifiable
Highland County..................      1/16/18  Attainment/Unclassifiable
Isle of Wight County.............      1/16/18  Attainment/Unclassifiable
James City County................      1/16/18  Attainment/Unclassifiable
King and Queen County............      1/16/18  Attainment/Unclassifiable
King George County...............      1/16/18  Attainment/Unclassifiable
King William County..............      1/16/18  Attainment/Unclassifiable
Lancaster County.................      1/16/18  Attainment/Unclassifiable
Lee County.......................      1/16/18  Attainment/Unclassifiable
Louisa County....................      1/16/18  Attainment/Unclassifiable
Lunenburg County.................      1/16/18  Attainment/Unclassifiable
Madison County...................      1/16/18  Attainment/Unclassifiable
Mathews County...................      1/16/18  Attainment/Unclassifiable
Mecklenburg County...............      1/16/18  Attainment/Unclassifiable
Middlesex County.................      1/16/18  Attainment/Unclassifiable
Montgomery County................      1/16/18  Attainment/Unclassifiable
Nelson County....................      1/16/18  Attainment/Unclassifiable
New Kent County..................      1/16/18  Attainment/Unclassifiable
Northampton County...............      1/16/18  Attainment/Unclassifiable
Northumberland County............      1/16/18  Attainment/Unclassifiable
Nottoway County..................      1/16/18  Attainment/Unclassifiable
Orange County....................      1/16/18  Attainment/Unclassifiable
Page County......................      1/16/18  Attainment/Unclassifiable
Patrick County...................      1/16/18  Attainment/Unclassifiable
Pittsylvania County..............      1/16/18  Attainment/Unclassifiable
Powhatan County..................      1/16/18  Attainment/Unclassifiable
Prince Edward County.............      1/16/18  Attainment/Unclassifiable
Prince George County.............      1/16/18  Attainment/Unclassifiable
Pulaski County...................      1/16/18  Attainment/Unclassifiable
Rappahannock County..............  ...........  Attainment/Unclassifiable
Richmond County..................      1/16/18  Attainment/Unclassifiable
Roanoke County...................      1/16/18  Attainment/Unclassifiable
Rockbridge County................      1/16/18  Attainment/Unclassifiable
Rockingham County................      1/16/18  Attainment/Unclassifiable
Russell County...................      1/16/18  Attainment/Unclassifiable
Scott County.....................      1/16/18  Attainment/Unclassifiable
Shenandoah County................      1/16/18  Attainment/Unclassifiable
Smyth County.....................      1/16/18  Attainment/Unclassifiable
Southampton County...............      1/16/18  Attainment/Unclassifiable

Spotsylvania County..............  ...........  Attainment/Unclassifiable
Stafford County..................  ...........  Attainment/Unclassifiable
Surry County.....................      1/16/18  Attainment/Unclassifiable
Sussex County....................      1/16/18  Attainment/Unclassifiable
Tazewell County..................      1/16/18  Attainment/Unclassifiable
Warren County....................  ...........  Attainment/Unclassifiable
Washington County................      1/16/18  Attainment/Unclassifiable
Westmoreland County..............      1/16/18  Attainment/Unclassifiable
Winchester City..................  ...........  Attainment/Unclassifiable
Wise County......................      1/16/18  Attainment/Unclassifiable
Wythe County.....................      1/16/18  Attainment/Unclassifiable
York County......................      1/16/18  Attainment/Unclassifiable
Bristol City.....................      1/16/18  Attainment/Unclassifiable
Buena Vista City.................      1/16/18  Attainment/Unclassifiable
Charlottesville City.............      1/16/18  Attainment/Unclassifiable
Chesapeake City..................      1/16/18  Attainment/Unclassifiable
Colonial Heights City............      1/16/18  Attainment/Unclassifiable
Covington City...................      1/16/18  Attainment/Unclassifiable
Danville City....................      1/16/18  Attainment/Unclassifiable
Emporia City.....................      1/16/18  Attainment/Unclassifiable
Franklin City....................      1/16/18  Attainment/Unclassifiable
Galax City.......................      1/16/18  Attainment/Unclassifiable
Hampton City.....................      1/16/18  Attainment/Unclassifiable
Harrisonburg City................      1/16/18  Attainment/Unclassifiable
Hopewell City....................      1/16/18  Attainment/Unclassifiable
Lexington City...................      1/16/18  Attainment/Unclassifiable
Lynchburg City...................      1/16/18  Attainment/Unclassifiable
Martinsville City................      1/16/18  Attainment/Unclassifiable
Newport News City................      1/16/18  Attainment/Unclassifiable
Norfolk City.....................      1/16/18  Attainment/Unclassifiable
Norton City......................      1/16/18  Attainment/Unclassifiable
Petersburg City..................      1/16/18  Attainment/Unclassifiable
Poquoson City....................      1/16/18  Attainment/Unclassifiable
Portsmouth City..................      1/16/18  Attainment/Unclassifiable
Radford City.....................      1/16/18  Attainment/Unclassifiable
Richmond City....................      1/16/18  Attainment/Unclassifiable
Roanoke City.....................      1/16/18  Attainment/Unclassifiable
Salem City.......................      1/16/18  Attainment/Unclassifiable
Staunton City....................      1/16/18  Attainment/Unclassifiable

Suffolk City.....................      1/16/18  Attainment/Unclassifiable
Virginia Beach City..............      1/16/18  Attainment/Unclassifiable
Waynesboro City..................      1/16/18  Attainment/Unclassifiable
Williamsburg City................      1/16/18  Attainment/Unclassifiable
----------------------------------------------------------------------------------------------------------------
\1\ Includes any Indian country in each county or area, unless otherwise specified. EPA is not determining the
  boundaries of any area of Indian country in this table, including any area of Indian country located in the
  larger designation area. The inclusion of any Indian country in the designation area is not a determination
  that the state has regulatory authority under the Clean Air Act for such Indian country.
\2\ This date is August 3, 2018, unless otherwise noted.

* * * * *

0
31. Section 81.348 is amended by revising the table titled
``Washington--2015 8-Hour Ozone NAAQS (Primary and Secondary)'' to read
as follows:

Sec.  81.348  Washington.

* * * * *

                                       Washington--2015 8-Hour Ozone NAAQS
                                             [Primary and Secondary]
----------------------------------------------------------------------------------------------------------------
                                                 Designation                           Classification
       Designated area \1\        ------------------------------------------------------------------------------
                                     Date \2\              Type              Date \2\             Type
----------------------------------------------------------------------------------------------------------------
Tri-Cities Area, WA..............      1/16/18  Unclassifiable...........
    Benton County.
    Franklin County.
    Walla Walla County.
Adams County.....................      1/16/18  Attainment/Unclassifiable
Asotin County....................      1/16/18  Attainment/Unclassifiable
Chelan County....................      1/16/18  Attainment/Unclassifiable
Clallam County...................      1/16/18  Attainment/Unclassifiable
Clark County.....................  ...........  Attainment/Unclassifiable
Columbia County..................      1/16/18  Attainment/Unclassifiable
Cowlitz County...................  ...........  Attainment/Unclassifiable
Douglas County...................      1/16/18  Attainment/Unclassifiable
Ferry County.....................      1/16/18  Attainment/Unclassifiable
Garfield County..................      1/16/18  Attainment/Unclassifiable
Grant County.....................      1/16/18  Attainment/Unclassifiable
Grays Harbor County..............      1/16/18  Attainment/Unclassifiable
Island County....................      1/16/18  Attainment/Unclassifiable
Jefferson County.................      1/16/18  Attainment/Unclassifiable
King County......................      1/16/18  Attainment/Unclassifiable
Kitsap County....................      1/16/18  Attainment/Unclassifiable
Kittitas County..................      1/16/18  Attainment/Unclassifiable
Klickitat County.................      1/16/18  Attainment/Unclassifiable
Lewis County.....................      1/16/18  Attainment/Unclassifiable
Lincoln County...................      1/16/18  Attainment/Unclassifiable
Mason County.....................      1/16/18  Attainment/Unclassifiable
Okanogan County..................      1/16/18  Attainment/Unclassifiable
Pacific County...................      1/16/18  Attainment/Unclassifiable

Pend Oreille County..............      1/16/18  Attainment/Unclassifiable
Pierce County....................      1/16/18  Attainment/Unclassifiable
San Juan County..................      1/16/18  Attainment/Unclassifiable
Skagit County....................      1/16/18  Attainment/Unclassifiable
Skamania County..................  ...........  Attainment/Unclassifiable
Snohomish County.................      1/16/18  Attainment/Unclassifiable
Spokane County...................      1/16/18  Attainment/Unclassifiable
Stevens County...................      1/16/18  Attainment/Unclassifiable
Thurston County..................      1/16/18  Attainment/Unclassifiable
Wahkiakum County.................      1/16/18  Attainment/Unclassifiable
Whatcom County...................      1/16/18  Attainment/Unclassifiable
Whitman County...................      1/16/18  Attainment/Unclassifiable
Yakima County....................      1/16/18  Attainment/Unclassifiable
----------------------------------------------------------------------------------------------------------------
\1\ Includes any Indian country in each county or area, unless otherwise specified. EPA is not determining the
  boundaries of any area of Indian country in this table, including any area of Indian country located in the
  larger designation area. The inclusion of any Indian country in the designation area is not a determination
  that the state has regulatory authority under the Clean Air Act for such Indian country.
\2\ This date is August 3, 2018, unless otherwise noted.

* * * * *

0
32. Section 81.349 is amended by revising the table titled ``West
Virginia--2015 8-Hour Ozone NAAQS (Primary and Secondary)'' to read as
follows:

Sec.  81.349  West Virginia.

* * * * *

                                     West Virginia--2015 8-Hour Ozone NAAQS
                                             [Primary and Secondary]
----------------------------------------------------------------------------------------------------------------
                                                 Designation                           Classification
       Designated area \1\        ------------------------------------------------------------------------------
                                     Date \2\              Type              Date \2\             Type
----------------------------------------------------------------------------------------------------------------
Barbour County...................      1/16/18  Attainment/Unclassifiable
Berkeley County..................  ...........  Attainment/Unclassifiable
Boone County.....................      1/16/18  Attainment/Unclassifiable
Braxton County...................      1/16/18  Attainment/Unclassifiable
Brooke County....................      1/16/18  Attainment/Unclassifiable
Cabell County....................      1/16/18  Attainment/Unclassifiable
Calhoun County...................      1/16/18  Attainment/Unclassifiable
Clay County......................      1/16/18  Attainment/Unclassifiable
Doddridge County.................      1/16/18  Attainment/Unclassifiable
Fayette County...................      1/16/18  Attainment/Unclassifiable
Gilmer County....................      1/16/18  Attainment/Unclassifiable
Grant County.....................      1/16/18  Attainment/Unclassifiable
Greenbrier County................      1/16/18  Attainment/Unclassifiable
Hampshire County.................  ...........  Attainment/Unclassifiable
Hancock County...................      1/16/18  Attainment/Unclassifiable
Hardy County.....................      1/16/18  Attainment/Unclassifiable

Harrison County..................      1/16/18  Attainment/Unclassifiable
Jackson County...................      1/16/18  Attainment/Unclassifiable
Jefferson County.................  ...........  Attainment/Unclassifiable
Kanawha County...................      1/16/18  Attainment/Unclassifiable
Lewis County.....................      1/16/18  Attainment/Unclassifiable
Lincoln County...................      1/16/18  Attainment/Unclassifiable
Logan County.....................      1/16/18  Attainment/Unclassifiable
McDowell County..................      1/16/18  Attainment/Unclassifiable
Marion County....................      1/16/18  Attainment/Unclassifiable
Marshall County..................      1/16/18  Attainment/Unclassifiable
Mason County.....................      1/16/18  Attainment/Unclassifiable
Mercer County....................      1/16/18  Attainment/Unclassifiable
Mineral County...................      1/16/18  Attainment/Unclassifiable
Mingo County.....................      1/16/18  Attainment/Unclassifiable
Monongalia County................      1/16/18  Attainment/Unclassifiable
Monroe County....................      1/16/18  Attainment/Unclassifiable
Morgan County....................      1/16/18  Attainment/Unclassifiable
Nicholas County..................      1/16/18  Attainment/Unclassifiable
Ohio County......................      1/16/18  Attainment/Unclassifiable
Pendleton County.................      1/16/18  Attainment/Unclassifiable
Pleasants County.................      1/16/18  Attainment/Unclassifiable
Pocahontas County................      1/16/18  Attainment/Unclassifiable
Preston County...................      1/16/18  Attainment/Unclassifiable
Putnam County....................      1/16/18  Attainment/Unclassifiable
Raleigh County...................      1/16/18  Attainment/Unclassifiable
Randolph County..................      1/16/18  Attainment/Unclassifiable
Ritchie County...................      1/16/18  Attainment/Unclassifiable
Roane County.....................      1/16/18  Attainment/Unclassifiable
Summers County...................      1/16/18  Attainment/Unclassifiable
Taylor County....................      1/16/18  Attainment/Unclassifiable
Tucker County....................      1/16/18  Attainment/Unclassifiable
Tyler County.....................      1/16/18  Attainment/Unclassifiable
Upshur County....................      1/16/18  Attainment/Unclassifiable
Wayne County.....................      1/16/18  Attainment/Unclassifiable
Webster County...................      1/16/18  Attainment/Unclassifiable
Wetzel County....................      1/16/18  Attainment/Unclassifiable
Wirt County......................      1/16/18  Attainment/Unclassifiable
Wood County......................      1/16/18  Attainment/Unclassifiable

Wyoming County...................      1/16/18  Attainment/Unclassifiable
----------------------------------------------------------------------------------------------------------------
\1\ Includes any Indian country in each county or area, unless otherwise specified. EPA is not determining the
  boundaries of any area of Indian country in this table, including any area of Indian country located in the
  larger designation area. The inclusion of any Indian country in the designation area is not a determination
  that the state has regulatory authority under the Clean Air Act for such Indian country.
\2\ This date is August 3, 2018, unless otherwise noted.

* * * * *

0
33. Section 81.350 is amended revising the table titled ``Wisconsin--
2015 8-Hour Ozone NAAQS (Primary and Secondary)'' to read as follows:

Sec.  81.350  Wisconsin.

* * * * *

                                       Wisconsin--2015 8-Hour Ozone NAAQS
                                             [Primary and Secondary]
----------------------------------------------------------------------------------------------------------------
                                                 Designation                           Classification
       Designated area \1\        ------------------------------------------------------------------------------
                                     Date \2\              Type              Date \2\             Type
----------------------------------------------------------------------------------------------------------------
Chicago, IL-IN-WI................  ...........  Nonattainment............  ...........  Marginal.
    Kenosha County (part):
        Inclusive and east of
         88th Avenue.
Door County, WI..................  ...........  Nonattainment............  ...........  Marginal (Rural
                                                                                Transport).
    Door County (part):
        Newport State Park
         Boundary.
Manitowoc County, WI.............  ...........  Nonattainment............  ...........  Marginal.
    Manitowoc County (part):
        Inclusive and east of the
         following roadways going
         from the northern county
         boundary to the southern
         county boundary:
         Saxonburg Road, Zander
         Road, Saxonburg Road,
         Tapawingo Road, Tannery
         Road, E County Road V,
         Tannery Road, E
         Hillcrest Road, Sunset
         Drive, County Road VV,
         Manitou Drive, County
         Road B, Goodwin Road, N
         Rapids Road, S Rapids
         Road, Calumet Avenue,
         Hecker Road, Silver
         Creek Road, Gass Lake
         Road, Clover Road,
         Center Road, County Road
         F, Westview Road, County
         Road X, S Union Road.
Northern Milwaukee/Ozaukee         ...........  Nonattainment............  ...........  Marginal.
 Shoreline, WI.
    Milwaukee County (part):
        Northeastern corner of
         Milwaukee County bounded
         by and inclusive of the
         following roadways going
         from the northern county
         border to Lake Michigan:
         Highway 57/N. Sherman
         Blvd/N. 43rd Street to
         W. Mill Road to Highway
         57/N. Green Bay Ave to
         W. Bender Road/Devon
         Street to N. Santa
         Monica Blvd to E. Belle
         Ave to southern boundary
         of Klode Park.
Ozaukee County (part):
    Inclusive and east of County.
        Road KW, Cedar Beach
         Road, 6 Mile Road,
         County Road A, Lovers
         Lane Road, Woodland
         Road, County Road KK,
         Willow Road, Highway 57,
         County Road W, N.
         Riverside Drive, E.
         Green Bay Avenue, S.
         Main Street, N. Green
         Bay Road, 12th Avenue,
         Wisconsin Avenue, Green
         Bay Road, S. Main
         Street, N. Cedarburg
         Road/Highway 57.
Sheboygan County, WI.............  ...........  Nonattainment............  ...........  Marginal.
    Sheboygan County (part):
        Inclusive and east of the
         following roadways going
         from the northern county
         boundary to the southern
         county boundary: Highway
         43, Wilson Lima Road,
         Minderhaud Road, County
         Road KK/Town Line Road,
         N 10th Street, County
         Road A S/Center Avenue,
         Gibbons Road, Hoftiezer
         Road, Highway 32, Palmer
         Road/Smies Road/Palmer
         Road, Amsterdam Road/
         County Road RR, Termaat
         Road.
Adams County.....................      1/16/18  Attainment/Unclassifiable
Ashland County...................      1/16/18  Attainment/Unclassifiable
Barron County....................      1/16/18  Attainment/Unclassifiable
Bayfield County..................      1/16/18  Attainment/Unclassifiable
Brown County.....................  ...........  Attainment/Unclassifiable
Buffalo County...................      1/16/18  Attainment/Unclassifiable
Burnett County...................      1/16/18  Attainment/Unclassifiable
Calumet County...................  ...........  Attainment/Unclassifiable
Chippewa County..................      1/16/18  Attainment/Unclassifiable

Clark County.....................      1/16/18  Attainment/Unclassifiable
Columbia County..................      1/16/18  Attainment/Unclassifiable
Crawford County..................      1/16/18  Attainment/Unclassifiable
Dane County......................      1/16/18  Attainment/Unclassifiable
Dodge County.....................  ...........  Attainment/Unclassifiable
Door County (part) remainder.....  ...........  Attainment/Unclassifiable
Douglas County...................      1/16/18  Attainment/Unclassifiable
Dunn County......................      1/16/18  Attainment/Unclassifiable
Eau Claire County................      1/16/18  Attainment/Unclassifiable
Florence County..................      1/16/18  Attainment/Unclassifiable
Fond du Lac County...............  ...........  Attainment/Unclassifiable
Forest County....................      1/16/18  Attainment/Unclassifiable
Grant County.....................      1/16/18  Attainment/Unclassifiable
Green County.....................      1/16/18  Attainment/Unclassifiable
Green Lake County................      1/16/18  Attainment/Unclassifiable
Iowa County......................      1/16/18  Attainment/Unclassifiable
Iron County......................      1/16/18  Attainment/Unclassifiable
Jackson County...................      1/16/18  Attainment/Unclassifiable
Jefferson County.................  ...........  Attainment/Unclassifiable
Juneau County....................      1/16/18  Attainment/Unclassifiable
Kenosha County (part) remainder..  ...........  Attainment/Unclassifiable
Kewaunee County..................  ...........  Attainment/Unclassifiable
La Crosse County.................      1/16/18  Attainment/Unclassifiable
Lafayette County.................      1/16/18  Attainment/Unclassifiable
Langlade County..................      1/16/18  Attainment/Unclassifiable
Lincoln County...................      1/16/18  Attainment/Unclassifiable
Manitowoc County (part) remainder  ...........  Attainment/Unclassifiable
Marathon County..................      1/16/18  Attainment/Unclassifiable
Marinette County.................      1/16/18  Attainment/Unclassifiable
Marquette County.................      1/16/18  Attainment/Unclassifiable
Menominee County.................      1/16/18  Attainment/Unclassifiable
Milwaukee County (part) remainder  ...........  Attainment/Unclassifiable
Monroe County....................      1/16/18  Attainment/Unclassifiable
Oconto County....................      1/16/18  Attainment/Unclassifiable
Oneida County....................      1/16/18  Attainment/Unclassifiable
Outagamie County.................      1/16/18  Attainment/Unclassifiable
Ozaukee County (part) remainder..  ...........  Attainment/Unclassifiable
Pepin County.....................      1/16/18  Attainment/Unclassifiable
Pierce County....................      1/16/18  Attainment/Unclassifiable

Polk County......................      1/16/18  Attainment/Unclassifiable
Portage County...................      1/16/18  Attainment/Unclassifiable
Price County.....................      1/16/18  Attainment/Unclassifiable
Racine County....................  ...........  Attainment/Unclassifiable
Richland County..................      1/16/18  Attainment/Unclassifiable
Rock County......................      1/16/18  Attainment/Unclassifiable
Rusk County......................      1/16/18  Attainment/Unclassifiable
St. Croix County.................      1/16/18  Attainment/Unclassifiable
Sauk County......................      1/16/18  Attainment/Unclassifiable
Sawyer County....................      1/16/18  Attainment/Unclassifiable
Shawano County...................      1/16/18  Attainment/Unclassifiable
Sheboygan County (part) remainder  ...........  Attainment/Unclassifiable
Taylor County....................      1/16/18  Attainment/Unclassifiable
Trempealeau County...............      1/16/18  Attainment/Unclassifiable
Vernon County....................      1/16/18  Attainment/Unclassifiable
Vilas County.....................      1/16/18  Attainment/Unclassifiable
Walworth County..................  ...........  Attainment/Unclassifiable
Washburn County..................      1/16/18  Attainment/Unclassifiable
Washington County................  ...........  Attainment/Unclassifiable
Waukesha County..................  ...........  Attainment/Unclassifiable
Waupaca County...................      1/16/18  Attainment/Unclassifiable
Waushara County..................      1/16/18  Attainment/Unclassifiable
Winnebago County.................      1/16/18  Attainment/Unclassifiable
Wood County......................      1/16/18  Attainment/Unclassifiable
Forest County Potawatomi               1/16/18  Attainment/Unclassifiable
 Community Indian Tribe \3\.
----------------------------------------------------------------------------------------------------------------
\1\ Includes any Indian country in each county or area, unless otherwise specified. EPA is not determining the
  boundaries of any area of Indian country in this table, including any area of Indian country located in the
  larger designation area. The inclusion of any Indian country in the designation area is not a determination
  that the state has regulatory authority under the Clean Air Act for such Indian country.
\2\ This date is August 3, 2018, unless otherwise noted.
\3\ Includes Indian country of the tribe listed in this table located in Forest County, Wisconsin. Information
  pertaining to areas of Indian country in this table is intended for Clean Air Act planning purposes only and
  is not an EPA determination of Indian country status or any Indian country boundary. EPA lacks the authority
  to establish Indian country land status, and is making no determination of Indian country boundaries, in this
  table.

* * * * *

0
34. Section 81.351 is amended by revising the table titled ``Wyoming--
2015 8-Hour Ozone NAAQS (Primary and Secondary)'' to read as follows:

Sec.  81.351  Wyoming.

* * * * *

                                        Wyoming--2015 8-Hour Ozone NAAQS
                                             [Primary and Secondary]
----------------------------------------------------------------------------------------------------------------
                                                 Designation                           Classification
       Designated area \1\        ------------------------------------------------------------------------------
                                     Date \2\              Type              Date \2\             Type
----------------------------------------------------------------------------------------------------------------
Albany County....................  ...........  Attainment/Unclassifiable
Big Horn County..................      1/16/18  Attainment/Unclassifiable
Campbell County..................      1/16/18  Attainment/Unclassifiable

Carbon County....................      1/16/18  Attainment/Unclassifiable
Converse County..................      1/16/18  Attainment/Unclassifiable
Crook County.....................      1/16/18  Attainment/Unclassifiable
Fremont County...................      1/16/18  Attainment/Unclassifiable
Goshen County....................      1/16/18  Attainment/Unclassifiable
Hot Springs County...............      1/16/18  Attainment/Unclassifiable
Johnson County...................      1/16/18  Attainment/Unclassifiable
Laramie County...................  ...........  Attainment/Unclassifiable
Lincoln County...................      1/16/18  Attainment/Unclassifiable
Natrona County...................      1/16/18  Attainment/Unclassifiable
Niobrara County..................      1/16/18  Attainment/Unclassifiable
Park County......................      1/16/18  Attainment/Unclassifiable
Platte County....................      1/16/18  Attainment/Unclassifiable
Sheridan County..................      1/16/18  Attainment/Unclassifiable
Sublette County..................      1/16/18  Attainment/Unclassifiable
Sweetwater County................      1/16/18  Attainment/Unclassifiable
Teton County.....................      1/16/18  Attainment/Unclassifiable
Uinta County.....................      1/16/18  Attainment/Unclassifiable
Washakie County..................      1/16/18  Attainment/Unclassifiable
Weston County....................      1/16/18  Attainment/Unclassifiable
----------------------------------------------------------------------------------------------------------------
\1\ Includes any Indian country in each county or area, unless otherwise specified. EPA is not determining the
  boundaries of any area of Indian country in this table, including any area of Indian country located in the
  larger designation area. The inclusion of any Indian country in the designation area is not a determination
  that the state has regulatory authority under the Clean Air Act for such Indian country.
\2\ This date is August 3, 2018, unless otherwise noted.

* * * * *

[FR Doc. 2018-11838 Filed 6-1-18; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 88, Number 142 (Wednesday, July 26, 2023)]
[Notices]
[Pages 48276-48277]
[FR Doc No: 2023-15827]

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

SECURITIES AND EXCHANGE COMMISSION

[SEC File No. 270-636, OMB Control No. 3235-0679]

Proposed Collection; Comment Request; Extension: Form PF and Rule
and Rule 204(b)-1

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

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') has submitted to the Office of Management
and Budget a request for extension of the previously approved
collection of information discussed below.
    Rule 204(b)-1 (17 CFR 275.204(b)-1) under the Investment Advisers
Act of 1940 (15 U.S.C. 80b-1 et seq.) implements sections 404 and 406
of the Dodd-Frank Wall Street Reform and Consumer Protection Act (the
``Dodd-Frank Act'') by requiring private fund advisers that have at
least $150 million in private fund assets under management to report
certain information regarding the private funds they advise on Form PF.
These advisers are the respondents to the collection of information.
Form PF is designed to facilitate the Financial Stability Oversight
Council's (``FSOC'') monitoring of systemic risk in the private fund
industry and to assist FSOC in determining whether and how to deploy
its regulatory tools with respect to nonbank financial companies. The
Commission and the Commodity Futures Trading Commission may also use
information collected on Form PF in their regulatory programs,
including examinations, investigations and investor protection efforts
relating to private fund advisers.
    Form PF divides respondents into two broad groups, Large Private
Fund Advisers and smaller private fund advisers. ``Large Private Fund
Advisers'' are advisers with at least $1.5 billion in assets under
management attributable to hedge funds (``large hedge fund advisers''),
advisers that manage ``liquidity funds'' and have at least $1 billion
in combined assets under management attributable to liquidity funds and
registered money market funds (``large liquidity fund advisers''), and
advisers with at least $2 billion in assets under management
attributable to private equity funds (``large private equity fund
advisers''). All other respondents are considered smaller private fund
advisers. The Commission estimates that most filers of Form PF have
already made their first filing, and so the burden hours applicable to
those filers will reflect only ongoing burdens, and not start-up
burdens. Accordingly, the Commission estimates the total annual
reporting and recordkeeping burden of the collection of information for
each respondent is as follows: (a) For smaller private fund advisers
making their first Form PF filing, an estimated amortized average
annual burden of 13 hours for each of the first three years; (b) for
smaller private fund advisers that already make Form PF filings, an
estimated amortized average annual burden of 15 hours for each of the
next three years; (c) for smaller private funds, an estimated average
annual burden of 5 hours for event reporting for smaller private equity
fund advisers for each of the next three years; (d) for large hedge
fund advisers making their first Form PF filing, an estimated amortized
average annual burden of 108 hours for each of the first three years;
(e) for large hedge fund advisers that already make Form PF filings, an
estimated amortized average annual burden of 600 hours for each of the
next three years; (f) for large hedge fund advisers, an estimated
average annual burden of 10 hours for current reporting for each of the
next three years; (g) for large liquidity fund advisers making their
first Form PF filing, an estimated amortized average annual burden of
67 hours for each of the first three years; (h) for large liquidity
fund advisers that already make Form PF filings, an estimated amortized
average annual burden of 280 hours for each of the next three years;
(i) for large private equity fund advisers making their first Form PF
filing, an estimated amortized average annual burden of 84 hours for
each of the first three years; (j) for large private equity fund
advisers that already make Form PF filings, an estimated amortized
average annual burden of 128 hours for each of the next three years;
and (k) for large private equity fund advisers, an estimated average
annual burden of 5 hours for event reporting for each of the next three
years.
    With respect to annual internal costs, the Commission estimates the
collection of information will result in 122.86 burden hours per year
on average for each respondent. With respect to external cost burdens,
the Commission estimates a range from $0 to $50,000 per adviser.
    Estimates of average burden hours and costs are made solely for the
purposes of the Paperwork Reduction Act and are not derived from a
comprehensive or even representative survey or study of the costs of
Commission rules and forms. The changes in burden hours are due to the
staff's estimates of the time costs and external costs that result from
the adopted amendments, the use of updated data, and the use of
different methodologies to calculate certain estimates. Compliance with
the collection of information requirements of Form PF is mandatory for
advisers that satisfy the criteria described in Instruction 1 to the
Form. Responses to the collection of information will be kept
confidential to the extent permitted by law. The Commission does not
intend to make public information reported on Form PF that is
identifiable to any particular adviser or private fund, although the
Commission may use Form PF information in an enforcement action. An
agency may not conduct or sponsor, and a person is not required to
respond to, a collection of information

unless it displays a currently valid OMB control number.
    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
shall 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 by September 25, 2023.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information under the PRA unless it
displays a currently valid OMB control number.
    Please direct your written comments to: David Bottom, Director/
Chief Information Officer, Securities and Exchange Commission, c/o John
Pezzullo, 100 F Street NE, Washington, DC 20549 or send an email to:
[email protected].

    Dated: July 21, 2023.
Sherry R. Haywood,
Assistant Secretary.
[FR Doc. 2023-15827 Filed 7-25-23; 8:45 am]
BILLING CODE 8011-01-P