[Federal Register: October 29, 2010 (Volume 75, Number 209)]
[Notices]
[Page 66769]
[DOCID:fr29oc10-78]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0378]

Draft Compliance Policy Guide Sec. 690.800 Salmonella in Animal
Feed; Availability; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; extension of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is extending to
December 31, 2010, the comment period for a notice of availability of a
draft compliance policy guide (CPG) that appeared in the Federal
Register of August 2, 2010 (75 FR 45130). In the document, FDA
requested comments on its proposal that certain criteria should be
considered in recommending enforcement action against animal feed or
feed ingredients that are adulterated due to the presence of
Salmonella. The Agency is taking this action in response to requests
for an extension to allow interested persons additional time to submit
comments.

DATES: Submit either electronic or written comments by December 31,
2010.

ADDRESSES: Submit electronic comments on the draft CPG to http://
www.regulations.gov. Submit written comments on the draft CPG to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Kim Young, Center for Veterinary
Medicine (HFV-230), Food and Drug Administration, 7519 Standish Pl.,
MPN-4, rm. 106, Rockville, MD 20855,<PHONE_NUMBER>, e-mail:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of August 2, 2010 (75 FR 45130), FDA
published a notice of availability of a draft CPG with a 90-day comment
period to request comments on its proposal that certain criteria should
be considered in recommending enforcement action against animal feed or
feed ingredients that are adulterated due to the presence of
Salmonella. The Agency has received a request for a 60-day extension of
the comment period for the draft CPG. The request conveyed concern that
the current 90-day comment period does not allow sufficient time to
develop a meaningful or thoughtful response to the draft CPG. FDA has
considered the request and is extending the comment period for the
draft CPG for 60 days, until December 31, 2010.

II. Request for Comments

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

    Dated: October 26, 2010.
Dara Corrigan,
Associate Commissioner for Regulatory Affairs.
[FR Doc. 2010-27448 Filed 10-28-10; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register: April 9, 2010 (Volume 75, Number 68)]
[Notices]
[Page 18195-18196]
[DOCID:fr09ap10-69]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

April 2, 2010.
    Take notice that the Commission received the following electric
rate filings:
    Docket Numbers: ER10-374-001.
    Applicants: Medicine Bow Power Partners, LLC.
    Description: Withdrawal of Request for Waiver of Medicine Bow Power
Partners, LLC.
    Filed Date: 03/26/2010.
    Accession Number: 20100326-5082.
    Comment Date: 5 p.m. Eastern Time on Friday, April 16, 2010.

    Docket Numbers: ER10-971-000.
    Applicants: Golden Spread Electric Cooperative, Inc.
    Description: Golden Spread Electric Cooperative, Inc submits
Amendment to First Revised Rate Schedule No. 23 et al.
    Filed Date: 03/31/2010.
    Accession Number: 20100401-0209.
    Comment Date: 5 p.m. Eastern Time on Wednesday, April 21, 2010.

    Docket Numbers: ER10-972-000.

    Applicants: New England Power Pool.
    Description: New England Power Pool submits NEPOOL Member.
Applications and Termination of NEPOOL Memberships.
    Filed Date: 03/31/2010.
    Accession Number: 20100401-0210.
    Comment Date: 5 p.m. Eastern Time on Wednesday, April 21, 2010.

    Docket Numbers: ER10-973-000.
    Applicants: Delmarva Power & Light Company.
    Description: Delmarva Power & Light Co submits an executed
construction agreement.
    Filed Date: 03/31/2010.
    Accession Number: 20100401-0211.
    Comment Date: 5 p.m. Eastern Time on Wednesday, April 21, 2010.

    Docket Numbers: ER10-974-000.
    Applicants: Big Horn II Wind Project LLC.
    Description: Big Horn II Wind Project LLC submits a request for
blanket authorization to make wholesale sales etc.
    Filed Date: 03/31/2010.
    Accession Number: 20100401-0212.
    Comment Date: 5 p.m. Eastern Time on Wednesday, April 21, 2010.

    Docket Numbers: ER10-975-000.
    Applicants: Juniper Canyon Wind Power LLC.
    Description: Juniper Canyon Wind Power LLC submits FERC Electric
Taiff, Original Volume No. 1.
    Filed Date: 03/31/2010.
    Accession Number: 20100401-0213.
    Comment Date: 5 p.m. Eastern Time on Wednesday, April 21, 2010.

    Docket Numbers: ER10-976-000.
    Applicants: Arizona Public Service Company.
    Description: Arizona Public Service Co submits an executed
Engineering & Procurement Agreement.
    Filed Date: 03/31/2010.
    Accession Number: 20100401-0214.
    Comment Date: 5 p.m. Eastern Time on Wednesday, April 21, 2010.

    Take notice that the Commission received the following open access
transmission tariff filings:
    Docket Numbers: OA07-32-010.
    Applicants: Entergy Services, Inc.
    Description: Entergy Services, Inc submits a compliance/refund
report relating to penalty assessments and distributions pursuant to
Order 890.
    Filed Date: 03/31/2010.
    Accession Number: 20100401-0232.
    Comment Date: 5 p.m. Eastern Time on Wednesday, April 21, 2010.

    Any person desiring to intervene or to protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214) on or before 5 p.m. Eastern time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. Protests will be considered by the Commission in
determining the appropriate action to be taken, but will not serve to
make protestants parties to the proceeding. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant. In reference to filings initiating a new proceeding,
interventions or protests submitted on or before the comment deadline
need not be served on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://
www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St. NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed dockets(s). For assistance
with any FERC Online service, please e-mail<EMAIL_ADDRESS>
or call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2010-8088 Filed 4-8-10; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 199 (Friday, October 14, 2016)]
[Notices]
[Pages 71182-71183]
[FR Doc No: 2016-24855]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2016-0041; Notice 1]

Notice of Receipt of Petition for Decision That Nonconforming
Model Year 2008 Chevrolet Silverado Trucks are Eligible for Importation

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation (DOT).

ACTION: Receipt of petition.

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SUMMARY: This document announces receipt by the National Highway
Traffic Safety Administration (NHTSA) of a petition for a decision that
model year (MY) 2008 Chevrolet Silverado trucks that were not
originally manufactured to comply with all applicable Federal motor
vehicle safety standards (FMVSS), are eligible for importation into the
United States because they are substantially similar to vehicles that
were originally manufactured for sale in the United States and that
were certified by their manufacturer as complying with the safety
standards (the U.S.-certified version of the 2008 Chevrolet Silverado
truck) and they are capable of being readily altered to conform to the
standards.

DATES: The closing date for comments on the petition is November 14,
2016.

ADDRESSES: Comments should refer to the docket and notice numbers above
and be submitted by any of the following methods:
     Federal eRulemaking Portal: Go to https://www.regulations.gov. Follow the online instructions for submitting
comments.
     Mail: Docket Management Facility: U.S. Department of
Transportation, 1200 New Jersey Avenue SE., West Building Ground Floor,
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery or Courier: West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue SE., between 9 a.m. and 5 p.m. ET,
Monday through Friday, except Federal holidays.
     Fax:<PHONE_NUMBER>.
    Instructions: Comments must be written in the English language, and
be no greater than 15 pages in length, although there is no limit to
the length of necessary attachments to the comments. If comments are
submitted in hard copy form, please ensure that two copies are
provided. If you wish to receive confirmation that your comments were
received, please enclose a stamped, self-addressed postcard with the
comments. Note that all comments

received will be posted without change to https://www.regulations.gov,
including any personal information provided. Please see the Privacy Act
heading below.
    Privacy Act: Anyone is able to search the electronic form of all
comments received into any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477-78).
    How to Read Comments Submitted to the Docket: You may read the
comments received by Docket Management at the address and times given
above. You may also view the documents from the Internet at https://www.regulations.gov. Follow the online instructions for accessing the
dockets. The docket ID number and title of this notice are shown at the
heading of this document notice. Please note that even after the
comment closing date, we will continue to file relevant information in
the Docket as it becomes available. Further, some people may submit
late comments. Accordingly, we recommend that you periodically search
the Docket for new material.

FOR FURTHER INFORMATION CONTACT: George Stevens, Office of Vehicle
Safety Compliance, NHTSA<PHONE_NUMBER>).

SUPPLEMENTARY INFORMATION:

Background

    Under 49 U.S.C. 30141(a)(1)(A), a motor vehicle that was not
originally manufactured to conform to all applicable FMVSS shall be
refused admission into the United States unless NHTSA has decided that
the motor vehicle is substantially similar to a motor vehicle
originally manufactured for importation into and sale in the United
States, certified under 49 U.S.C. 30115, and of the same model year as
the model of the motor vehicle to be compared, and is capable of being
readily altered to conform to all applicable FMVSS.
    Petitions for eligibility decisions may be submitted by either
manufacturers or importers who have registered with NHTSA pursuant to
49 CFR part 592. As specified in 49 CFR 593.7, NHTSA publishes notice
in the Federal Register of each petition that it receives, and affords
interested persons an opportunity to comment on the petition. At the
close of the comment period, NHTSA decides, on the basis of the
petition and any comments that it has received, whether the vehicle is
eligible for importation. The agency then publishes this decision in
the Federal Register.
    Wallace Environmental Testing Laboratories (WETL), Inc. of Houston,
Texas (Registered Importer R-90-005) has petitioned NHTSA to decide
whether nonconforming 2008 Chevrolet Silverado trucks are eligible for
importation into the United States. The vehicles which WETL believes
are substantially similar are MY 2008 Chevrolet Silverado trucks sold
in the United States and certified by their manufacturer as conforming
to all applicable FMVSS.
    The petitioner claims that it compared non-U.S. certified MY 2008
Chevrolet Silverado trucks to their U.S.-certified counterparts, and
found the vehicles to be substantially similar with respect to
compliance with most FMVSS.
    WETL submitted information with its petition intended to
demonstrate that non-U.S. certified MY 2008 Chevrolet Silverado trucks,
as originally manufactured, conform with many applicable FMVSS in the
same manner as their U.S.-certified counterparts, or are capable of
being readily altered to conform to those standards. Specifically, the
petitioner claims that the non U.S.-certified MY 2008 Chevrolet
Silverado trucks, as originally manufactured, conform to: Standard Nos.
102 Transmission Shift Lever Sequence, Starter Interlock, and
Transmission Braking Effect, 103 Windshield Defrosting and Defogging
Systems, 104 Windshield Wiping and Washing Systems, 106 Brake Hoses,
108 Lamps, reflective devices, and associated equipment, 111 Rear
visibility, 113 Hood Latch System, 114 Theft Protection, 116 Motor
Vehicle Brake Fluids, 118 Power-Operated Window, Partition, and Roof
Panel System, 124 Accelerator Control Systems, 126 Electronic Stability
Control Systems, 135 Light vehicle brake systems, 138 Tire Pressure
Monitoring Systems, 201 Occupant Protection in Interior Impact, 202a
Head Restraints, 203 Impact Protection for the Driver from the Steering
Control System, 204 Steering Control Rearward Displacement, 205 Glazing
Materials, 206 Door Locks and Door Retention Components, 207 Seating
Systems, 208 Occupant Crash Protection, 210 Seat Belt Assembly
Anchorages, 212 Windshield Mounting, 213 Child Restraint Systems, 214
Side Impact Protection, 216 Roof Crush Resistance, 219 Windshield Zone
Intrusion, 225 Child Restraint Anchorage Systems, 301 Fuel System
Integrity, and 302 Flammability of Interior Materials.
    The petitioner also contends that the subject non-U.S certified
vehicles are capable of being readily altered to meet the following
standards, in the manner indicated:
    Standard No. 101 Controls and Displays: Addition of the brake
warning indicator to fully comply with the standard.
    Standard No. 110 Tire Selection and Rims: Installation of the
required tire information placard.
    The petitioner additionally states that a vehicle identification
plate must be affixed to the vehicle near the left windshield pillar to
meet the requirements of 49 CFR part 565.
    All comments received before the close of business on the closing
date indicated above will be considered, and will be available for
examination in the docket at the above addresses both before and after
that date. To the extent possible, comments filed after the closing
date will also be considered. Notice of final action on the petition
will be published in the Federal Register pursuant to the authority
indicated below.

    Authority:  49 U.S.C. 30141(a)(1)(A), (a)(1)(B), and (b)(1); 49
CFR 593.7; delegation of authority at 49 CFR 1.95 and 501.8.

Jeffrey M. Giuseppe,
Director, Office of Vehicle Safety Compliance.
[FR Doc. 2016-24855 Filed 10-13-16; 8:45 am]
 BILLING CODE 4910-59-P


[Federal Register Volume 88, Number 236 (Monday, December 11, 2023)]
[Notices]
[Page 85938]
[FR Doc No: 2023-27144]

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SECURITIES AND EXCHANGE COMMISSION

[SEC File No. 270-457, OMB Control No. 3235-0518]

Submission for OMB Review; Comment Request; Extension: Form CB,
Tender Offer/Rights Offering Notification Form

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 this request for extension of the previously approved
collection of information discussed below.
    Form CB (17 CFR 239.800) is a document filed in connection with a
tender offer for a foreign private issuer. This form is used to report
an issuer tender offer conducted in compliance with Exchange Act Rule
13e-4(h)(8) (17 CFR 240.13e-4(h)(8)), a third-party tender offer
conducted in compliance with Exchange Act Rule 14d-1(c) (17 CFR
240.14d-1(c)) and a going private transaction conducted in accordance
with Rule 13e-3(g)(6) (17 CFR 240.13e-3(g)(6)). Form CB is also used by
a subject company pursuant to Exchange Act Rule 14e-2(d) (17 CFR
240.14e-2(d)). This information is made available to the public.
Information provided on Form CB is mandatory. Form CB takes
approximately 0.5 hours per response to prepare and is filed by
approximately 58 respondents annually. We estimate that 25% of the 0.5
hours per response (0.125 hours) is prepared by the respondent for an
annual reporting burden of 7 hours (0.125 hours per response x 58
responses).
    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.
    The public may view background documentation for this information
collection at the following website: www.reginfo.gov. Find this
particular information collection by selecting ``Currently under 30-day
Review--Open for Public Comments'' or by using the search function.
Written comments and recommendations for the proposed information
collection should be sent within 30 days of publication of this notice
by January 10, 2024 to (i) www.reginfo.gov/public/do/PRAMain and (ii)
David Bottom, Director/Chief Information Officer, Securities and
Exchange Commission, c/o John Pezzullo, 100 F Street NE, Washington, DC
20549, or by sending an email to: [email protected].

    Dated: December 6, 2023.
Sherry R. Haywood,
Assistant Secretary.
[FR Doc. 2023-27144 Filed 12-8-23; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 78, Number 137 (Wednesday, July 17, 2013)]
[Proposed Rules]
[Pages 42733-42736]
[FR Doc No: 2013-17105]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2013-0523]
RIN 1625-AA00

Safety Zone; Cleveland Dragon Boat Festival and Head of the
Cuyahoga, Cuyahoga River, Cleveland, OH

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Coast Guard proposes to establish a temporary safety zone
on the Cuyahoga River, Cleveland, OH. This proposed rule is intended to
restrict vessels from a portion of the Cuyahoga River during the Dragon
Boat Festival and Head of the Cuyahoga boating events. The safety zone
established by this proposed rule is necessary to protect the
surrounding public, spectators, participants, and vessels from the
hazards associated with rowing regattas.

DATES: Comments and related materials must be received by the Coast
Guard on or before August 16, 2013.

ADDRESSES: You may submit comments identified by docket number USCG-
2013-0523 using any one of the following methods:
    (1) Federal eRulemaking Portal: http://www.regulations.gov.
    (2) Fax:<PHONE_NUMBER>.
    (3) Mail: Docket Management Facility (M-30), U.S. Department of
Transportation, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590-0001.
    (4) Delivery: at the same as mail address above, between 9 a.m. and
5 p.m., Monday through Friday, except federal holidays. The telephone
number is<PHONE_NUMBER>.
    To avoid duplication, please use only one of these four methods.
See the ``Public Participation and Request for Comments'' portion of
the SUPPLEMENTARY INFORMATION section below for instructions on
submitting comments.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email LT Christopher Mercurio, Chief of Waterway Management,
U.S. Coast Guard Sector Buffalo; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>If you have questions on viewing or
submitting material to the docket, call Barbara Hairston, Program
Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Table of Acronyms

DHS Department of Homeland Security
FR Federal Register
NPRM Notice of Proposed Rulemaking
TFR Temporary Final Rule

A. Public Participation and Request for Comments

    We encourage you to participate in this rulemaking by submitting
comments and related materials. All comments received will be posted
without change to http://www.regulations.gov and will include any
personal information you have provided.

1. Submitting Comments

    If you submit a comment, please include the docket number for this
rulemaking (USCG-2013-0523), indicate the specific section of this
document to which each comment applies, and provide a reason for each
suggestion or recommendation. You may submit your comments and material
online at http://www.regulations.gov or by fax, mail, or hand delivery,
but please use only one of these means. If you submit a comment online,
it will be considered received by the Coast Guard when the comment is
successfully transmitted. If you fax, hand deliver, or mail your
comment, it will be considered received by the Coast Guard when the
comment is received at the Docket Management Facility. We recommend
that you include your name and a mailing address, an email address, or
a telephone number in the body of your document so that we can contact
you if we have questions regarding your submission.
    To submit your comment online, go to http://www.regulations.gov,
type the docket number [USCG-2013-0523] in the ``SEARCH'' box and click
``SEARCH.'' Click on ``Submit a Comment'' on the line associated with
this rulemaking.
    If you submit your comments by mail or hand delivery, submit them
in an unbound format, no larger than 8\1/2\ by 11 inches, suitable for
copying and electronic filing. If you submit comments by mail and would
like to know that they reached the Facility, please enclose a stamped,
self-addressed postcard or envelope. We will consider all comments and
material received during the comment period and may change the rule
based on your comments.

2. Viewing Comments and Documents

    To view comments, as well as documents mentioned in this preamble
as being available in the docket, go to http://www.regulations.gov,
type the docket number (USCG-2013-0523) in the ``SEARCH'' box and click
``SEARCH.'' Click on Open Docket Folder on the line associated with
this rulemaking. You may also visit the Docket Management Facility in
Room W12-140 on the ground floor of the Department of Transportation
West Building, 1200 New Jersey Avenue SE., Washington, DC 20590,
between 9 a.m.

and 5 p.m., Monday through Friday, except Federal holidays.

3. Privacy Act

    Anyone can search the electronic form of comments received into any
of our dockets by the name of the individual submitting the comment (or
signing the comment, if submitted on behalf of an association,
business, labor union, etc.). You may review a Privacy Act notice
regarding our public dockets in the January 17, 2008, issue of the
Federal Register (73 FR 3316).

4. Public Meeting

    We do not now plan to hold a public meeting. But you may submit a
request for one using one of the methods specified under ADDRESSES.
Please explain why you believe a public meeting would be beneficial. If
we determine that one would aid this rulemaking, we will hold one at a
time and place announced by a later notice in the Federal Register.

B. Regulatory History and Information

    The Head of the Cuyahoga (HOTC) rowing regatta has occurred
annually for over a decade and the Dragon Boat Festival for the last 7
years. In response to past years' events, the Coast Guard has
established a temporary safety zone to protect the boating public. For
example, in 2012, the Captain of the Port Buffalo published a temporary
final rule (77 FR 54813) to ensure the safety of spectators and vessels
during the rowing event. The safety zone proposed in this Notice of
Proposed Rulemaking (NPRM) is identical in size, location, and effect
as that established by the 2012 TFR.

C. Basis and Purpose

    As mentioned in the ``Regulatory History and Information'' section,
the HOTC is an annual rowing regatta that has taken place for over a
decade. The HOTC takes place on the Cuyahoga River along a 4800 meter
course and attracts numerous rowing clubs and programs from across the
U.S. In 2013, the HOTC will occur between 8 a.m. and 4 p.m. on
September 21, 2012.
    In conjunction with the HOTC, the 7th Annual Cleveland Dragon Boat
Festival will take place from Superior/Nautica Bend to just north of
the Detroit Superior Viaduct Bridge. The Dragon Boat festival will
feature three boat head to head races being held over the course of the
day.
    The Captain of the Port Buffalo has determined that the HOTC and
the Cleveland Dragon Boat Festival rowing events present significant
hazards to public spectators and participants.

D. Discussion of Proposed Rule

    With the aforementioned hazards in mind, the Captain of the Port
Buffalo proposes to establish a temporary safety zone that will ensure
the safety of spectators and vessels during the HOTC and during the
Cleveland Dragon Boat Festival. The proposed safety zone will be
effective and enforced from 8 a.m. until 4 p.m. on September 21, 2013.
    The proposed safety zone will encompass all waters of the Cuyahoga
River, Cleveland, OH from a line drawn perpendicular from position
41[deg]28'32'' N, 081[deg]40'16'' W (NAD 83) just south of the
Interstate 490 bridge, north to position 41[deg]29'55'' N,
081[deg]42'23'' W (NAD 83) just past the Detroit-Superior Viaduct
bridge.
    Entry into, transiting, or anchoring within the proposed safety
zone is prohibited unless authorized by the Captain of the Port Buffalo
or his on-scene representative. The Captain of the Port or his on-scene
representative may be contacted via VHF Channel 16.

E. Regulatory Analyses

    We developed this proposed rule after considering numerous statutes
and executive orders related to rulemaking. Below we summarize our
analyses based on these statutes or executive orders.

1. Regulatory Planning and Review

    This proposed rule is not a significant regulatory action under
section 3(f) of Executive Order 12866, Regulatory Planning and Review,
as supplemented by Executive Order 13563, Improving Regulation and
Regulatory Review, and does not require an assessment of potential
costs and benefits under section 6(a)(3) of Executive Order 12866 or
under section 1 of Executive Order 13563. The Office of Management and
Budget has not reviewed it under those Orders. It is not
``significant'' under the regulatory policies and procedures of the
Department of Homeland Security (DHS). We conclude that this proposed
rule is not a significant regulatory action because we anticipate that
it will have minimal impact on the economy, will not interfere with
other agencies, will not adversely alter the budget of any grant or
loan recipients, and will not raise any novel legal or policy issues.
The safety zone created by this proposed rule will be relatively small
and enforced for relatively short time. Also, the proposed safety zone
is designed to minimize its impact on navigable waters. Furthermore,
the proposed safety zone has been designed to allow vessels to transit
around it. Thus, restrictions on vessel movement within that particular
area are expected to be minimal. Under certain conditions, moreover,
vessels may still transit through the proposed safety zone when
permitted by the Captain of the Port.

2. Impact on Small Entities

    The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as
amended, requires federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this
proposed rule will not have a significant economic impact on a
substantial number of small entities. This proposed rule may affect the
following entities, some of which might be small entities: The owners
of operators of vessels intending to transit or anchor in a portion of
the Cuyahoga River near Cleveland, Ohio between 8 a.m. to 4 p.m. on
September 21, 2013.
    This proposed safety zone will not have a significant economic
impact on a substantial number of small entities for the following
reasons: The safety zone will be in effect for only 9 and a half hours.
Although the safety zone would apply to the entire width of the river,
traffic would be allowed to pass through the zone with the permission
of the Captain of the Port. Before the activation of the zone, we would
issue maritime advisories widely available to users of the river.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this proposed rule
would have a significant economic impact on it, please submit a comment
(see ADDRESSES) explaining why you think it qualifies and how and to
what degree this proposed rule would economically affect it.

3. Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this proposed rule. If the rule would affect
your small business, organization, or governmental jurisdiction and you
have questions concerning its provisions or options for compliance,
please contact the person listed in the FOR FURTHER INFORMATION
CONTACT, above. The Coast Guard will not retaliate against small
entities that question or complain about this

proposed rule or any policy or action of the Coast Guard.

4. Collection of Information

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

5. Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this proposed rule under that Order and
determined that this rule does not have implications for federalism.

6. Protest Activities

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

7. Unfunded Mandates Reform Act

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

8. Taking of Private Property

    This proposed rule would not cause a taking of private property or
otherwise have taking implications under Executive Order 12630,
Governmental Actions and Interference with Constitutionally Protected
Property Rights.

9. Civil Justice Reform

    This proposed rule meets applicable standards in sections 3(a) and
3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize
litigation, eliminate ambiguity, and reduce burden.

10. Protection of Children From Environmental Health Risks

    We have analyzed this proposed rule under Executive Order 13045,
Protection of Children from Environmental Health Risks and Safety
Risks. This proposed rule is not an economically significant rule and
would not create an environmental risk to health or risk to safety that
might disproportionately affect children.

11. Indian Tribal Governments

    This proposed rule does not have tribal implications under
Executive Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it would not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.

12. Energy Effects

    This proposed rule is not a ``significant energy action'' under
Executive Order 13211, Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use.

13. Technical Standards

    This proposed rule does not use technical standards. Therefore, we
did not consider the use of voluntary consensus standards.

14. Environment

    We have analyzed this proposed rule under Department of Homeland
Security Management Directive 023-01 and Commandant Instruction
M16475.lD, which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (NEPA)(42 U.S.C. 4321-4370f), and have
made a preliminary determination that this action is one of a category
of actions that do not individually or cumulatively have a significant
effect on the human environment. This proposed rule is categorically
excluded, under figure 2-1, paragraph (34)(g), of the Commandant
Instruction because it involves the establishment of a safety zone.
    A preliminary environmental analysis checklist and a preliminary
categorical exclusion determination are available in the docket where
indicated under ADDRESSES. We seek any comments or information that may
lead to the discovery of a significant environmental impact from this
proposed rule.

List of Subjects in 33 CFR Part 165

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

    For the reasons discussed in the preamble, the Coast Guard proposes
to amend 33 CFR parts 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

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

    Authority: 33 U.S.C. 1231; 46 U.S.C. Chapters 701, 3306, 3703;
50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Pub.
L. 107-295, 116 Stat. 2064; Department of Homeland Security
Delegation No. 0170.1.

0
2. Add Sec.  165.T09-0523 to read as follows:

Sec.  165.T09-0523  Safety Zone; Cleveland Dragon Boat Festival and
Head of the Cuyahoga, Cuyahoga River, Cleveland, OH.

    (a) Location. The proposed safety zone will encompass all waters of
the Cuyahoga River, Cleveland, OH from a line drawn perpendicular from
position 41[deg]28'32'' N, 081[deg]40'16'' W (NAD 83) just south of the
Interstate 490 bridge, north to position 41[deg] 29'55'' N,
081[deg]42'23'' W (NAD 83) just past the Detroit-Superior Viaduct
bridge.
    (b) Effective and Enforcement Period. This regulation is effective
and will be enforced on September 21, 2013 from 8 a.m. until 4 p.m.
    (c) Definitions. The following definitions apply to this section:
    (1) ``On-scene Representative'' means any Coast Guard commissioned,
warrant, or petty officer designated by the Captain of the Port Buffalo
to monitor a safety zone, permit entry into the zone, give legally
enforceable orders to persons or vessels within the zones, and take
other actions authorized by the Captain of the Port.
    (2) ``Public vessel'' means vessels owned, chartered, or operated
by the U.S., or by a State or political subdivision thereof.
    (d) Regulations. (1) In accordance with the general regulations in
section 165.23 of this part, entry into, transiting, or anchoring
within this safety zone is prohibited unless authorized by the Captain
of the Port Buffalo or his designated on-scene representative.
    (2) This safety zone is closed to all vessel traffic, except as may
be permitted by the Captain of the Port Buffalo or his designated on-
scene representative.
    (3) The ``on-scene representative'' of the Captain of the Port
Buffalo is any Coast Guard commissioned, warrant or petty officer who
has been designated

by the Captain of the Port Buffalo to act on his behalf.
    (4) Vessel operators desiring to enter or operate within the safety
zone shall contact the Captain of the Port Buffalo or his on-scene
representative to obtain permission to do so. The Captain of the Port
Buffalo or his on-scene representative may be contacted via VHF Channel
16. Vessel operators given permission to enter or operate in the safety
zone must comply with all directions given to them by the Captain of
the Port Buffalo, or his on-scene representative.
    (e) Exemption. Public vessels, as defined in paragraph (c) of this
section, are exempt from the requirements in this section.
    (f) Waiver. For any vessel, the Captain of the Port Buffalo or his
designated representative may waive any of the requirements of this
section, upon finding that operational conditions or other
circumstances are such that application of this section is unnecessary
or impractical for the purposes of public or environmental safety.
    (g) Notification. The Captain of the Port Buffalo will notify the
public that the safety zones in this section is or will be enforced by
all appropriate means to the affected segments of the public including
publication in the Federal Register as practicable, in accordance with
33 CFR 165.7(a). Such means of notification may also include, but are
not limited to Broadcast Notice to Mariners or Local Notice to
Mariners. The Captain of the Port will issue a Broadcast Notice to
Mariners notifying the public when enforcement of the safety zone is
cancelled.

    Dated: June 27, 2013.
J. S. Imahori,
Commander, U.S. Coast Guard, Acting Captain of the Port Buffalo.
[FR Doc. 2013-17105 Filed 7-16-13; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 79, Number 105 (Monday, June 2, 2014)]
[Notices]
[Pages 31387-31390]
[FR Doc No: 2014-12685]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Notice of Passenger Facility Charge (PFC) Approvals and
Disapprovals

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Monthly Notice of PFC Approvals and Disapprovals. In April
2014, there were seven applications approved. This notice also includes
information on two applications, one approved in March 2012 and the
other approved in January 2014, inadvertently left off the March 2012
and January 2014 notices, respectively. Additionally, five approved
amendments to previously approved applications are listed.

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SUMMARY: The FAA publishes a monthly notice, as appropriate, of PFC
approvals and disapprovals under the provisions of the Aviation Safety
and Capacity Expansion Act of 1990 (Title IX of the Omnibus Budget
Reconciliation Act of 1990) (Public Law 101-508) and Part 158 of the
Federal Aviation Regulations (14 CFR Part 158). This notice is
published pursuant to paragraph d of Sec.  158.29.

PFC Applications Approved

    Public Agency: Peninsula Airport Commission, Newport News,
Virginia.
    Application Number: 12-03-C-00-PHF.
    Application Type: Impose and use a PFC.
    PFC Level: $4.50.
    Total PFC Revenue Approved In This Decision: $12,090,644.

    Earliest Charge Effective Date: March 1, 2017.
    Estimated Charge Expiration Date: March 1, 2022.
    Class of Air Carriers Not Required to Collect PFC'S: Air carriers
operating under Part 135 or Part 298 on an on-demand, non-scheduled
whole plane charter basis and filing FAA Form 1800-31.
    Determination: Approved. Based on information submitted in the
public agency's application, the FAA has determined that the proposed
class accounts for less than 1 percent of the total annual enplanements
at Newport News/Williamsburg International Airport.
    Brief Description of Projects Approved for Collection at And Use:
Taxiway A lighting (design).
    Wetlands mitigation.
    Taxiway A design.
    Outbound baggage handling system replacement.
    Snow removal equipment.
    Baggage claim expansion (design).
    Security checkpoint (planning and design).
    PFC application development.
    PFC application administration.
    Runway 17/35 lighting (design).
    Brief Description of Projects Approved for Collection: Taxiway A
reconstruction--construction.
    Baggage claim expansion (construction).
    Security checkpoint (construction).
    Taxiways A and F (design).
    Taxiways A and F (construction).
    Decision Date: March 21, 2012.

FOR FURTHER INFORMATION CONTACT: Jeffrey Breeden, Washington Airports
District Office,<PHONE_NUMBER>.

    Public Agency: Barkley Regional Airport Authority, Paducah,
Kentucky.
    Application Number: 14-03-C-00-PAH.
    Application Type: Impose and use a PFC.
    PFC Level: $4.50.
    Total PFC Revenue Approved In This Decision: $532,931.
    Earliest Charge Effective Date: January 1, 2017.
    Estimated Charge Expiration Date: October 1, 2025.
    Classes of Air Carriers Not Required to Collect PFC'S: (1) Air
taxi/commercial operators enplaning less than 200 annual passengers at
Barkley Regional Airport (PAH); and (2) large certificated air carriers
filing DOT Form T-100, conducting only nonscheduled operations at
(PAH), and enplaning less than 200 annual passengers at PAH.
    Determination: Approved. Based on information submitted in the
public agency's application, the FAA has determined that each proposed
class accounts for less than 1 percent of the total annual enplanements
at PAH.
    Brief Description of Project Approved for Collection At And Use:
Perimeter road construction.
    Aircraft board stairs.
    Pave access road.
    Rehabilitate 6,300-square-yard apron.
    Construct supplemental lighted wind cones.
    Construct taxilanes site grade and drain.
    Construct terminal building pipe bollards.
    Construct commute-a-walk concrete pads.
    Repave aircraft rescue and firefighting station turn-around.
    New terminal location study.
    Refurbish 1980 snow plow.
    Purchase five 800 MHz security radios.
    Design and construct runway safety area 22 improvement.
    Design and construct apron overlay phase 1.
    Design and construct Watergate east of runway 4.
    Design and construct drive and security fence.
    Design and construct waterline extension and fire hydrant.
    Design and construct apron overlay phase 2.
    Replace security patrol vehicle.
    Rebuild waste water lift/grinder station.
    Purchase end loader/snow blower.
    Renovate 1990 snow plow.
    Tree trimming for runway 32 approach.
    Glycol recapture system design.
    Expand/update airfield equipment building.
    Replace old power vault medium intensity taxiway lighting
regulator.
    Re-grade between taxiway A south and runway 4.
    Terminal footprint study.
    Replace failed rotating beacon.
    Construct Circle Drive.
    Replace three existing security gates.
    New air compressor at fire station.
    Wildlife assessment study.
    Surface painted holding position signs.
    Clean/reseal joints, terminal apron.
    Breathing packs for aircraft rescue and firefighting.
    Survey electrical load and provide vault generator.
    Phase A tiedown apron and taxilane.
    Slope protection of runway 4 runway safety area, phase 1.
    Seal coat runways and taxiways, phase 1.
    Aircraft wheelchair lift.
    Satellite radio mobile communication system.
    Slope protection of runway 4 runway safety area, phase 2.
    Seal coat runways and taxiways, phase 2.
    Phase B tiedown apron and taxilane.
    Slope protection for runway safety area, runway 4.
    Storm drainage research and design.
    Airport layout plan update.
    Design for terminal re-roof.
    Friction measuring equipment.
    Construct restroom in secured gate area.
    Renovation of existing storm sewer, phase A.
    Design and phase A construction of concrete apron.
    Identification badge card printer.
    Aircraft rescue and firefighting vehicle.
    Perimeter fence security upgrade design.
    Renovate terminal for efficient movement.
    Security enhancements (gate controllers).
    Concrete apron phase B.
    New terminal environmental assessment.
    Rehabilitate terminal roof.
    Rehabilitate terminal building re-roof, phase B.
    Perimeter/security fence upgrade.
    Remark runway 14/32 to Global Positioning System Area Navigation
standards.
    Update 800 MHz radio system.
    Replace storm sewer system under apron.
    Replace taxiways A, B, C west, and F north edge lights.
    Replace security inspection vehicle.
    Corrective marking, runway 4/22 to runway 5/23.
    Brief Description of Withdrawn Projects: Fuel truck spill
containment pad.
    Fuel truck water supply hose.
    Fire station repair to National Institute for Occupational Safety
and Health standards.
    Date of Withdrawal: January 15, 2014.
    Decision Date: January 21, 2014.

FOR FURTHER INFORMATION CONTACT: Cynthia Wills, Memphis Airports
District Office,<PHONE_NUMBER>.

    Public Agency: Niagara Frontier Transportation Authority, Buffalo,
New York.
    Application Number: 13-10-C-00-BUF.
    Application Type: Impose and use a PFC.
    PFC Level: $4.50.
    Total PFC Revenue Approved In This Decision: $478,540.

    Earliest Charge Effective Date: August 1, 2014.
    Estimated Charge Expiration Date: September 1, 2014.
    Class of Air Carriers Not Required to Collect PFC'S: Part 135 air
taxi/commercial operators filing FAA Form 1800-31.
    Determination: Approved. Based on information submitted in the
public agency's application, the FAA has determined that the proposed
class accounts for less than 1 percent of the total annual enplanements
at Buffalo Niagara International Airport (BUF).
    Brief Description of Projects Approved for Collection At BUF And
Use At BUF At A $4.50 PFC Level: Runway 14 runway protection zone land
acquisition.
    West side waterline replacement.
    Brief Description of Projects Approved for Collection At BUF And
Use At BUF At A $3.00 PFC Level: Upgrade terminal restrooms.
    Liquid chemical storage facility.
    New aircraft rescue and firefighting station (design only).
    Brief Description of Project Approved For Collection At BUF And Use
At Niagara Falls International Airport At A $4.50 PFC Level: Runway 6/
24 runway safety area improvements, phase 2.
    Brief Description of Disapproved Project: Purchase of security
equipment.
    Determination: Disapproved. The project requested four vehicles;
however airports of a similar size are typically eligible for only one
vehicle. In addition, the public agency failed to provide required
documentation that is necessary in order to establish PFC eligibility
in accordance with Sec.  158.15(b).
    Brief Description of Withdrawn Projects: Salt barn.
    Remain-overnight apron improvements.
    Purchase passenger movement equipment.
    Date of Withdrawal: April 4, 2014.
    Decision Date: April 9, 2014.

FOR FURTHER INFORMATION CONTACT: Jeffrey Breeden, Washington Airports
District Office,<PHONE_NUMBER>.

    Public Agency: City of Atlanta, Georgia.
    Application Number: 14-05-C-00-ATL.
    Application Type: Impose and use a PFC.
    PFC Level: $4.50.
    Total PFC Revenue Approved In This Decision: $23,550,000.
    Earliest Charge Effective Date: December 1, 2023.
    Estimated Charge Expiration Date: February 1, 2024.
    Class of Air Carriers Not Required To Collect PFC'S: Air taxi/
commercial operators when enplaning revenue passengers in limited,
irregular, special service air taxi/commercial operations such as air
ambulance services, student instruction, and non-stop sightseeing
flights that begin and end at Hartsfield-Jackson Atlanta International
Airport (ATL) and are concluded within a 25-mile radius of the airport.
    Determination: Approved. Based on information submitted in the
public agency's application, the FAA has determined that the proposed
class accounts for less than 1 percent of the total annual enplanements
at ATL.
    Brief Description of Project Approved for Collection At And Use At
A $4.50 Pfc Level: Concourse T-north optimization, phase 3.
    Brief Description of Withdrawn Project: Drainage improvements for
land acquisition for airport expansion east.
    Date of Withdrawal: January 8, 2014.
    Decision Date: April 10, 2014.

FOR FURTHER INFORMATION CONTACT: Parks Preston, Atlanta Airports
District Office,<PHONE_NUMBER>.

    Public Agency: City of Hailey and County of Blaine, Hailey, Idaho.
    Application Number: 14-09-C-00-SUN.
    Application Type: Impose and use a PFC.
    PFC Level: $4.50.
    Total PFC Revenue Approved In This Decision: $2,787,259.
    Earliest Charge Effective Date: July 1, 2014.
    Estimated Charge Expiration Date: July 1, 2028.
    Class of Air Carriers Not Required To Collect PFC'S: Air taxi/
commercial operators filing FAA Form 1800-31.
    Determination: Approved. Based on information submitted in the
public agency's application, the FAA has determined that the proposed
class accounts for less than 1 percent of the total annual enplanements
at Friedman Memorial Airport.
    Brief Description of Projects Approved For Collection And Use:
Runway safety area formulation.
    Acquire snow removal equipment.
    Master plan.
    Relocate southwest taxilane bypass.
    Relocate general aviation apron.
    Perimeter fence relocation.
    Runway safety area grading.
    Relocate taxiway A and obliterate taxiway B.
    Relocate power supply to precision approach path indicator.
    Relocate automated weather observing system.
    Relocate snow removal equipment/aircraft rescue and firefighting
building.
    Relocate terminal area apron.
    Relocate cargo apron.
    Relocate hangars.
    Rehabilitate terminal building.
    Relocate north taxilane.
    Relocate central bypass apron.
    Runway rehabilitation.
    PFC administration.
    Decision Date: April 11, 2014.

FOR FURTHER INFORMATION CONTACT: Jason Garwood, Helena Airports
District Office,<PHONE_NUMBER>.

    Public Agency: Port of Pasco, Pasco, Washington.
    Application Number: 14-10-C-00-PSC.
    Application Type: Impose and use a PFC.
    PFC Level: $4.50.
    Total PFC Revenue Approved In This Decision: $40,881,455.
    Earliest Charge Effective Date: August 1, 2023.
    Estimated Charge Expiration Date: August 1, 2045.
    Class Of Air Carriers Not Required To Collect PFC'S: None.
    Brief Description of Project Approved for Collection And Use:
Terminal building reconfiguration and expansion.
    Decision Date: April 11, 2014.

FOR FURTHER INFORMATION CONTACT: Trang Tran, Seattle Airports District
Office,<PHONE_NUMBER>.

    Public Agency: Peninsula Airport Commission, Newport News,
Virginia.
    Application Number: 14-04-U-00-PHF.
    Application Type: Use PFC revenue.
    PFC Level: $4.50.
    Total PFC Revenue Approved For Use In This Decision: $1,452,511.
    Estimated Charge Effective Date: May 1, 2026.
    Estimated Charge Expiration Date: December 1, 2037.
    Class of Air Carriers Not Required To Collect PFC'S: No change from
previous decision.
    Brief Description of Project Approved For Use: Taxiway A
(construction).
    Decision Date: April 16, 2014.

FOR FURTHER INFORMATION CONTACT: Jeffrey Breeden, Washington Airports
District Office,<PHONE_NUMBER>.

    Public Agency: Capital Region Airport Commission, Richmond,
Virginia.
    Application Number: 14-06-C-00-RIC.
    Application Type: Impose and use a PFC.
    PFC Level: $4.50.
    Total PFC Revenue Approved In This Decision: $34,350,000.
    Earliest Charge Effective Date: October 1, 2019.
    Estimated Charge Expiration Date: March 1, 2025.

    Class of Air Carriers Not Required to Collect PFC'S: Part 135 on-
demand air taxi/commercial operators filing FAA Form 1800-31.
    Determination: Approved. Based on information submitted in the
public agency's application, the FAA has determined that the proposed
class accounts for less than 1 percent of the total annual enplanements
at MOB.
    Brief Description of Projects Approved for Collection And Use:
Reconstruction and realignment of taxiway M.
    East side roadway and utilities project.
    Professional services PFC preparation and administration.
    Brief Description of Projects Approved for Collection: Construct
snow removal equipment building.
    Construct cargo apron improvements.
    Construct general aviation apron improvements.
    Reconstruction of taxiway E and portions of taxiway L.
    Decision Date: April 16, 2014.

FOR FURTHER INFORMATION CONTACT: Jeffrey Breeden, Washington Airports
District Office,<PHONE_NUMBER>.

    Public Agency: County of Sonoma, Santa Rosa, California.
    Application Number: 14-06-C-00-STS.
    Application Type: Impose and use a PFC.
    PFC Level: $4.50.
    Total PFC Revenue Approved In This Decision: $8,039,573.
    Earliest Charge Effective Date: June 1, 2014.
    Estimated Charge Expiration Date: April 1, 2026.
    Class of Air Carriers Not Required To Collect Pfc's: None.
    Brief Description of Projects Approved for Collection And Use:
Terminal building renovation and expansion.
    Runway safety area enhancement.
    Decision Date: April 22, 2014.

FOR FURTHER INFORMATION CONTACT: Neil Kumar, San Francisco Airports
District Office,<PHONE_NUMBER>.

                                           Amendments to PFC Approvals
----------------------------------------------------------------------------------------------------------------
                                                                                Original         Amended
                                     Amendment       Original         Amended        estimated       estimated
    Amendment No. city, state      approved date   approved net    approved net     charge exp.     charge exp.
                                                    PFC revenue     PFC revenue        date            date
----------------------------------------------------------------------------------------------------------------
12-04-C-01-DAL Dallas, TX.......        04/03/14     $13,637,816     $13,037,816        10/01/27        10/01/27
10-02-C-02-PHF Newport News, VA.        04/10/14      15,866,709      20,114,239        03/01/17        05/01/26
12-03-C-01-PHF Newport News, VA.        04/10/14      12,090,644      18,017,555        03/01/22        12/01/37
08-09-C-01-BLI Bellingham, WA...        04/10/14       2,548,830       2,250,912        09/01/14        07/01/10
05-06-C-01-ISP Islip, NY........        04/23/14      37,133,218      36,789,972        08/01/15        07/01/15
----------------------------------------------------------------------------------------------------------------

    Issued in Washington, DC, on May 23, 2014.
Joe Hebert,
Manager, Financial Analysis and Passenger Facility Charge Branch.
[FR Doc. 2014-12685 Filed 5-30-14; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 85, Number 193 (Monday, October 5, 2020)]
[Rules and Regulations]
[Pages 62577-62578]
[FR Doc No: 2020-21884]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2020-0626; Airspace Docket No. 20-ANM-23]
RIN 2120-AA66

Amendment of Class E Airspace; Leadville, CO

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action modifies Class E airspace extending upward from
700 feet above the surface at Lake County Airport. This action also
updates the airport's geographic coordinates.

DATES: Effective 0901 UTC, December 31, 2020. The Director of the
Federal Register approves this incorporation by reference action under
Title 1 Code of Federal Regulations part 51, subject to the annual
revision of FAA Order 7400.11 and publication of conforming amendments.

ADDRESSES: FAA Order 7400.11E, Airspace Designations and Reporting
Points, and subsequent amendments can be viewed online at https://www.faa.gov//air_traffic/publications/. For further information, you
can contact the Airspace Policy Group, Federal Aviation Administration,
800 Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783. The Order is also available for inspection at the National
Archives and Records Administration (NARA). For information on the
availability of FAA Order 7400.11E at NARA, email<EMAIL_ADDRESS>or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.

FOR FURTHER INFORMATION CONTACT: Matthew Van Der Wal, Federal Aviation
Administration, Western Service Center, Operations Support Group, 2200
S 216th Street, Des Moines, WA 98198; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. 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. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it modifies Class E airspace at Lake County Airport, Leadville, CO,
to ensure the safety and management of Instrument Flight Rules (IFR)
operations at the airport.

History

    The FAA published a notice of proposed rulemaking in the Federal
Register (85 FR 43511; July 17, 2020) for Docket No. FAA-2020-0626, to
modify Class E airspace at Lake County Airport, Leadville, CO.
Interested parties were invited to participate in this rulemaking
effort by submitting written comments on the proposal to the FAA. No
comments were received.
    Class E5 airspace designations are published in paragraph 6005 of
FAA Order 7400.11E, dated July 21, 2020, and effective September 15,
2020, which is incorporated by reference in 14 CFR 71.1. The Class E
airspace designation listed in this document will be published
subsequently in the Order.

Availability and Summary of Documents for Incorporation by Reference

    This document amends FAA Order 7400.11E, Airspace Designations and
Reporting Points, dated July 21, 2020, and effective September 15,
2020. FAA Order 7400.11E is publicly available as listed in the
ADDRESSES section of this document. FAA Order 7400.11E lists Class A,
B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Rule

    This amendment to Title 14 Code of Federal Regulations part 71
modifies Class E airspace, extending upward from 700 feet above the
surface, at Lake County Airport. This airspace area is described as
follows: That airspace extending upward from 700 feet above the surface
within a 3.5-mile radius of the airport, and within 3 miles each side
of the 164[deg] bearing from the airport, extending from the 3.5-mile
radius to 14.5 miles south of the airport, and within 2.7 miles each
side of the 350[deg] bearing from the airport, extending from the 3.5-
mile radius to 14.7 miles north of Lake County Airport.
    This action also updates the airport's geographic coordinates to
``Lat. 39[deg]13'10'' N, long. 106[deg]18'59'' W.''
    FAA Order 7400.11, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

Regulatory Notices and Analyses

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current, is
non-controversial, and unlikely to result in adverse or negative
comments. It, therefore: (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); and (3) does not warrant preparation of a regulatory evaluation
as the anticipated impact is so minimal. Since this is a routine matter
that will only affect air traffic procedures and air navigation, it is
certified that this rule, when promulgated, would not have a
significant economic impact on a substantial number of small entities
under the criteria of the Regulatory Flexibility Act.

Environmental Review

    The FAA has determined that this action qualifies for categorical
exclusion under the National Environmental Policy Act in accordance
with FAA Order 1050.1F, ``Environmental Impacts: Policies and
Procedures,'' paragraph 5-6.5a. This airspace action is not expected to
cause any potentially significant environmental impacts, and no
extraordinary circumstances exist that warrant preparation of an
environmental assessment.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

    In consideration of the foregoing, the Federal Aviation
Administration amends 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for 14 CFR part 71 continues to read as
follows:

    Authority: 49 U.S.C. 106(f), 106(g), 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.11E,
Airspace Designations and Reporting Points, dated July 21, 2020, and
effective September 15, 2020, is amended as follows:

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth.

* * * * *

ANM CO E5 Leadville, CO [Amended]

Lake County Airport, CO
    (Lat. 39[deg]13'10'' N, long. 106[deg]18'59'' W)

    That airspace extending upward from 700 feet above the surface
within a 3.5-mile radius of the airport, and within 3 miles each
side of the 164[deg] bearing from the airport, extending from the
3.5-mile radius to 14.5 miles south of the airport, and within 2.7
miles each side of the 350[deg] bearing from the airport, extending
from the 3.5-mile radius to 14.7 miles north of Lake County Airport.

    Issued in Seattle, Washington, on September 28, 2020.
B.G. Chew,
Acting Group Manager, Operations Support Group, Western Service Center.
[FR Doc. 2020-21884 Filed 10-2-20; 8:45 am]
BILLING CODE 4910-13-P


October 19, 2006

MEMORANDUM

SUBJECT:	Economic Impact Analysis for Hospital/Medical/Infectious Waste
Incinerators (HMIWI) 5-Year Review

FROM:	Tom Walton

Economist

ABCG (C439-02)

TO:		Mary Johnson

Engineer, ESG  (D243-01)

Section 129 of the Clean Air Act requires EPA to regulate
hospital/medical/infectious waste incinerators (HMIWI), and requires
emission limits for nine pollutants, including hydrogen chloride (HCl),
carbon monoxide (CO), lead (Pb), cadmium (Cd), mercury (Hg), particulate
matter (PM), dioxins, nitrogen oxides (NOX), and sulfur dioxide (SO2).
This document addresses   SEQ CHAPTER \h \r 1 the economic impacts of
the proposed changes resulting from the 5-year review of the HMIWI
standards, which were promulgated in September 1997.

Economic impact analyses focus on changes in market prices and output
levels.  If changes in market prices and output levels in the primary
markets are significant enough, impacts on other markets are also
examined.  This analysis began assessing the magnitude of the cost of
the changes due to the proposed 5-year review by comparing annualized
costs to annual sales for seventy of the seventy-six facilities
estimated to incur additional costs (sales were unavailable for six of
the facilities).

Control Costs

EPA estimates that the national total costs for the 76 currently
operating HMIWI to comply with the proposed changes resulting from the
5-year review would be approximately $488,000 in the first year of
compliance and $308,000 per year for subsequent years.  For purposes of
assessing the economic impacts of the proposed changes, the total
annualized cost of the changes is estimated to be $328,000.  This total
annualized cost was determined by first annualizing at 7 percent over 15
years the difference between the first year costs and subsequent year
costs for each of the 76 HMIWI, and adding to that value the subsequent
year costs for each HMIWI; followed by then combining the annualized
costs for the 76 HMIWI.  As shown in Table 1, the total annualized cost
of $328,000 is distributed among the 76 HMIWI.  The average additional
control costs-to-sales ratio in percentage terms is 0.003 percent.  The
costs-to-sales ratios range from 0.0006 percent to 0.06 percent.
Because of the small size of these regulatory costs, no additional
market analysis is needed.

Conclusions

Neither the modest national costs nor the facility level costs are
anticipated to significantly impact any market.  Because of the trend
towards fewer incinerators (prior to the original proposal there were
about 3,700 HMIWI units; at promulgation there were about 2,400 units;
now there are 76), it is possible that some facility may stop
incineration earlier than it would in the absence of the proposed
revisions to the regulations.  If a facility did stop incineration, it
would likely be a result of the availability of a less expensive
alternative to incineration rather than a result of the quite small
costs associated with the 5-year review as proposed.  Since no facility
is expected to be significantly impacted and, regardless, there are only
four small business facilities currently operating HMIWI units, a
finding of no significant economic impact on a substantial number of
small entities is very clear.

 PAGE

 PAGE   1


[Federal Register Volume 88, Number 127 (Wednesday, July 5, 2023)]
[Notices]
[Pages 42999-43001]
[FR Doc No: 2023-14160]

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

DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket No. FRA-2023-0002-N-12]

Proposed Agency Information Collection Activities; Comment
Request

AGENCY: Federal Railroad Administration (FRA), Department of
Transportation (DOT).

ACTION: Notice of information collection; request for comment.

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

SUMMARY: Under the Paperwork Reduction Act of 1995 (PRA) and its
implementing regulations, this notice announces that FRA is forwarding
the Information Collection Request (ICR) abstracted below to the Office
of Management and Budget (OMB) for review and comment. The ICR
describes the information collection and its expected burden. On April
21, 2023, FRA published a notice providing a 60-day period for public
comment on the ICR.

DATES: Interested persons are invited to submit comments on or before
August 4, 2023.

ADDRESSES: Written comments and recommendations for the proposed ICR
should be sent within 30 days of publication of this notice to
www.reginfo.gov/public/do/PRAMain. Find the particular ICR by selecting
``Currently under Review--Open for Public Comments'' or by using the
search function.

FOR FURTHER INFORMATION CONTACT: Ms. Arlette Mussington, Information
Collection Clearance Officer, at email: [email protected] or
telephone:<PHONE_NUMBER> or Ms. Joanne Swafford, Information
Collection Clearance Officer, at email: [email protected] or
telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The PRA, 44 U.S.C. 3501-3520, and its
implementing regulations, 5 CFR part 1320, require Federal agencies to
issue two notices seeking public comment on information collection
activities before OMB may approve paperwork packages. See 44 U.S.C.
3506, 3507; 5 CFR 1320.8 through 1320.12. On April 21, 2023, FRA
published a 60-day notice in the Federal Register soliciting public
comment on the ICR for which it is now seeking OMB approval. See 88 FR
24657.
    FRA has received one comment related to the proposed collection of
information. The Chief Economist of the Bureau of Economic Analysis
(BEA) sent an electronic letter date May 30, 2023, expressing BEA's
strong support for FRA's continued collection of on the Accident/
Incident Reporting and Recordkeeping forms. The Chief Economist noted
that the data collected on these forms are crucial to key components of
BEA's economic analyses and requested that FRA keep BEA informed of any
modifications to these forms. Before OMB decides whether to approve
this proposed collection of information, it must provide 30-days'
notice for public comment. Federal law requires OMB to approve or
disapprove paperwork packages between 30 and 60 days after the 30-day
notice is published. 44 U.S.C. 3507(b)-(c); 5 CFR 1320.12(d); see also
60 FR 44978, 44983, Aug. 29, 1995. This ICR responds to the information
collection mandate in Section 22421(b) of the Infrastructure Investment
and Jobs Act (IIJA) and also provides routine updates to 49 CFR part
225's overall information collection request renewal.
    OMB believes the 30-day notice informs the regulated community to
file relevant comments and affords the agency adequate time to digest
public comments before it renders a decision. 60 FR 44983, Aug. 29,
1995. Therefore, respondents should submit their respective comments to
OMB within 30 days of publication to best ensure having their full
effect.

    Comments are invited on the following ICR regarding: (1) Whether
the information collection activities are necessary for FRA to properly
execute its functions, including whether the information will have
practical utility; (2) the accuracy of FRA's estimates of the burden of
the information collection activities, including the validity of the
methodology and assumptions used to determine the estimates; (3) ways
for FRA to enhance the quality, utility, and clarity of the information
being collected; and (4) ways to minimize the burden of information
collection activities on the public, including the use of automated
collection techniques or other forms of information technology.
    The summary below describes the ICR that FRA will submit for OMB
clearance as the PRA requires:
    Title: Accident/Incident Reporting and Recordkeeping.
    OMB Control Number: 2130-0500.
    Abstract: The railroad accident/incident reporting regulations in
49 CFR part 225 require railroads to submit reports summarizing
collisions, derailments, and certain other accidents/incidents
involving damages above a periodically revised dollar threshold, as
well as certain injuries to passengers, employees, and other persons on
railroad property. As the reporting requirements and the information
needed regarding each category of accident/incident are unique, a
different form is used for each category.
    In response to the mandate in IIJA Section 22421,\1\ FRA intends to
utilize Form FRA F 6180.54 Special Study Blocks 49a and 49b to collect
the following information for a projected five-year period: (1) the
length of the involved trains, in feet, and (2) the number of crew
members who were aboard a controlling locomotive involved in an
accident at the time of such accident. This modification produces a
minimal additional burden with respect to what is already being
reported, as FRA estimates that the utilization of the Special Study
Blocks will require an additional 2 minutes to complete, for a total
average burden time of approximately 2 hours and 2 minutes per form,
adding an additional 57 hours to the overall collection request.
---------------------------------------------------------------------------

    \1\ Specifically, IIJA Section 22421(b) requires FRA to update
Special Study Block 49 on Form FRA F 6180.54, for a period of five
years, to collect information on: (1) the number of cars and length
of trains involved in an accident/incident; and (2) the number of
crew members who were aboard a controlling locomotive involved in an
accident at the time of such accident. Railroads are already
required to report the number of cars in the consist of a train
involved in an accident on Form FRA F 6180.54, Field 35.
---------------------------------------------------------------------------

    FRA has made multiple adjustments to its estimated paperwork burden
for the entire part 225 collection request, resulting in a reduction of
5,563 hours, from 35,846 hours in the current inventory, to 30,283
hours in the requested inventory. The primary reason for the reduction
in the estimated paperwork burden is the expected decrease in the
number of submissions. Specifically, under Sec.  225.19(d), FRA expects
submissions will decrease significantly from 11,636 hours to 7,040
hours due to a reduction in the number of injuries reported in the last
two years. There is no change in the method of collection; this is a
routine update for this 3-year ICR renewal period.
    Type of Request: Revision of a currently approved collection.
    Affected Public: Businesses
    Form(s): FRA F 6180.54; .55; .55a; .56; .57; .78; .81; .97; .98;
.107; .150.
    Respondent Universe: 784 railroads.
    Frequency of Submission: On occasion.
    Reporting Burden:

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Average                      Total cost
             CFR Section                      Respondent universe               Total annual responses         time per    Total annual    equivalent in
                                                                                response    burden hours     U.S. dollar
                                                                          (A)..............................          (B)     (C = A * B)        (D = C *
                                                                                wage rates)
                                                                                \2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
225.6(a)--Consolidated reporting--    784 railroads.....................  0.33 requests....................  40.00 hours           13.20       $1,028.41
 Request to FRA by parent
 corporation to treat its commonly
 controlled carriers as a single
 railroad carrier for purposes of
 this part.
                                     -------------------------------------------------------------------------------------------------------------------
    --(b) Written agreement by                                  The burden for this requirement is included in Sec.   225.6(a).
     parent corporation with FRA on
     specific subsidiaries included
     in its railroad system.
                                     -------------------------------------------------------------------------------------------------------------------
    --(c) Notification by parent                                The burden for this requirement is included in Sec.   225.6(a).
     corporation regarding any
     change in the subsidiaries
     making up its railroad system
     and amended written agreement
     with FRA.
                                     -------------------------------------------------------------------------------------------------------------------
225.9--Telephonic reports of certain  784 railroads.....................  2,589.00 phone reports...........        15.00          647.25       50,427.25
 accidents/incidents and other                                                                                minutes
 events.
225.11--Reporting of accidents/       784 railroads.....................  1,699.00 forms...................  2 hours + 2        3,454.63      269,150.22
 incidents--Form FRA F 6180.54 (IIJA                                                                             minutes
 created an additional burden of 2
 minutes to what is already being
 reported.).
225.12(a)--Rail equipment accident/   784 railroads.....................  732.00 forms.....................        15.00          183.00       14,257.53
 incident reports alleging human                                                                                minutes
 factor as cause--Form FRA F 6180.81.
    --(b) Part I Form FRA F 6180.78   784 railroads.....................  800 notices + 800 notice copies +   10 minutes          333.83       26,008.70
     (Notices).                                                            3,200 copies + 10 copies.         + 3 minutes
    --(c) Joint operations..........  784 railroads.....................  73.00 reports....................        20.00           24.00        1,869.84
                                                                                minutes
    --(d) Late identification.......  784 railroads.....................  20 attachments + 20 notices......        10.00            6.67          519.66
                                                                                minutes
    --(g) Employee statement          Railroad employees................  60.00 statements.................   1.50 hours           90.00       $7,011.90
     supplementing railroad accident
     report (Part II Form FRA
     6180.78).
    --(g)(3) Employee confidential    Railroad employees................  5.00 letters.....................   2.00 hours           10.00          779.10
     letter.
225.13(A)--Late reports--RR           784 railroads.....................  50.00 late reports...............   2.00 hours          100.00        7,791.00
 discovery of improperly omitted
 report of accident/incident.
--(B) RR late/amended report of       784 railroads.....................  20 amended reports + 30 copies...   1 hour + 3           21.50        1,675.07
 accident/incident based on employee                                                                             minutes
 statement supplementing RR accident
 report.
225.18(a)--RR narrative report of     784 railroads.....................  12.00 reports....................        15.00            3.00          233.73
 possible alcohol/drug involvement                                                                               minutes
 in accident/incident.
--(b) Reports required by Sec.        784 railroads.....................  5.00 reports.....................        30.00            2.50          194.78
 219.209(b) appended to rail                                                                                minutes
 equipment accident/incident report.

225.19(a)--Rail-highway grade         784 railroads.....................  2,161.50 forms...................   2.00 hours        4,323.00      336,804.93
 crossing accident/incident report--
 Form FRA F 6180.57.
    --(d) Death, injury, or           784 railroads.....................  7,040.00 forms...................    1.00 hour        7,040.00      548,486.40
     occupational illness (Form FRA
     F 6180.55a).
225.21--Railroad injury and illness   784 railroads.....................  9,408.00 forms...................        10.00        1,568.00      122,162.88
 summary--Form FRA F 6180.55.                                                                                minutes
225.21--Annual railroad report of     784 railroads.....................  784.00 forms.....................        15.00          196.00       15,270.36
 employee hours and casualties, by                                                                               minutes
 state--Form FRA F 6180.56.
225.21/25--Railroad employee injury   784 railroads.....................  4,000.00 forms...................    1.00 hour        4,000.00      311,640.00
 and/or illness record--Form FRA F
 6180.98.
    --Copies of forms to employees..  784 railroads.....................  3.60 form copies.................         2.00            0.12            9.35
                                                                                minutes
225.21--Initial rail equipment        784 railroads.....................  10,194.00 forms..................        30.00        5,097.00      397,107.27
 accident/incident record--Form FRA                                                                              minutes
 F 6180.97.
                                     -------------------------------------------------------------------------------------------------------------------
    --Completion of Form FRA F        FRA anticipates zero railroad submissions during this 3-year ICR period.
     6180.97 because of rail
     equipment involvement.
                                     -------------------------------------------------------------------------------------------------------------------
    --Alternative record for          784 railroads.....................  150.00 forms.....................        75.00          187.50       14,608.13
     illnesses claimed to be work                                                                                minutes
     related--Form FRA F 6180.107.
    --Highway User Statement--RR      784 railroads.....................  721.00 letters/forms.............        50.00          600.83       46,810.67
     cover letter and Form FRA F                                                                                minutes
     6180.150 sent out to
     potentially injured travelers
     involved in a highway-rail
     grade crossing accident/
     incident.
    --Form FRA F 6180.150 completed   117 injured individuals...........  117.00 forms.....................        45.00           87.75        6,836.60
     by highway user and sent back                                                                               minutes
     to railroad.
225.25(h)--Posting of monthly         784 railroads.....................  9,408.00 lists...................         5.00          784.00       61,081.44
 summary.                                                                                minutes
225.27(a)(1)--Retention of records..  784 railroads.....................  7,500.00 records.................         2.00          250.00       19,477.50
                                                                                minutes
                                     -------------------------------------------------------------------------------------------------------------------
    --Record of Form FRA F 6180.107s      The estimated paperwork burden for this requirement is included in 225.21 (Alternative record for illnesses
                                                                                claimed to be work related).
                                     -------------------------------------------------------------------------------------------------------------------
    --Record of Monthly Lists.......  784 railroads.....................  9,408.00 records.................         2.00          313.60       24,432.58
                                                                                minutes
    (a)(2)--Record of Form FRA F      784 railroads.....................  10,194.00 records................         2.00          339.80       26,473.82
     6180.97.                                                                                minutes
    --Record of employee human        784 railroads.....................  1,464.00 records.................         2.00           48.80        3,802.01
     factor attachments.                                                                                minutes
225.33--Internal Control Plans--      784 railroads.....................  10.00 amendments.................   6.00 hours           60.00        4,674.60
 Amendments.
225.35--Access to records and         784 railroads.....................  784.00 lists.....................        20.00          261.33       20,360.22
 reports.                                                                                minutes
225.37(a)--Optical media transfer of  FRA anticipates zero submissions
 reports, updates, and amendments.     during this 3-year ICR period.
    (c)(2)--Electronic submission of  784 railroads.....................  4,704.00 submissions.............         3.00          235.20       18,324.43
     reports, updates, and                                                                                minutes
     amendments.
        Totals \3\..................  784 railroads.....................  85,570 responses.................          N/A          30,283       2,359,310
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Total Estimated Annual Responses: 85,570.
---------------------------------------------------------------------------

    \2\ The dollar equivalent cost is derived from the 2021 Surface
Transportation Board Full Year Wage A&B data series using the
appropriate employee group hourly wage rage that includes a 75
percent overhead charge.
    \3\ Totals may not add due to rounding.
---------------------------------------------------------------------------

    Total Estimated Annual Burden: 30,283 hours.
    Total Estimated Annual Burden Hour Dollar Cost Equivalent:
$2,359,310.
    FRA informs all interested parties that it may not conduct or
sponsor, and a respondent is not required to respond to, a collection
of information that does not display a currently valid OMB control
number.
    Authority: 44 U.S.C. 3501-3520.

Brett A. Jortland,
Deputy Chief Counsel.
[FR Doc. 2023-14160 Filed 7-3-23; 8:45 am]
BILLING CODE 4910-06-P


[Federal Register Volume 88, Number 101 (Thursday, May 25, 2023)]
[Notices]
[Pages 33888-33889]
[FR Doc No: 2023-11162]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-P-3293]

Determination That Chirocaine (Levobupivacaine) Injection, 2.5
Milligrams (Base)/Milliliter, 10 Milliliter and 30 Milliliter Vials, 5
Milligrams (Base)/Milliliter, 10 Milliliter and 30 Milliliter Vials and
7.5 Milligrams (Base)/Milliliter, 10 Milliliter and 30 Milliliter
Vials, Were Not Withdrawn From Sale for Reasons of Safety or
Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) has
determined that Chirocaine (levobupivacaine) injection, 2.5 milligrams
(mg) (base)/milliliter (mL), 10 mL and 30 mL vials, 5 mg (base)/mL, 10
mL and 30 mL vials and 7.5 mg (base)/mL, 10 mL and 30 mL vials, were
not withdrawn from sale for reasons of safety or effectiveness. This
determination will allow FDA to approve abbreviated new drug
applications (ANDAs) for levobupivacaine injection, 2.5 milligrams (mg)
(base)/milliliter (mL), 10 mL and 30 mL vials, 5 mg (base)/mL, 10 mL
and 30 mL vials and 7.5 mg (base)/mL, 10 mL and 30 mL vials, if all
other legal and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Donna Tran, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 6213, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: Section 505(j) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)) allows the submission of
an ANDA to market a generic version of a previously approved drug
product. To obtain approval, the ANDA applicant must show, among other
things, that the generic drug product: (1) has the same active
ingredient(s), dosage form, route of administration, strength,
conditions of use, and (with certain exceptions) labeling as the listed
drug, which is a

version of the drug that was previously approved and (2) is
bioequivalent to the listed drug. ANDA applicants do not have to repeat
the extensive clinical testing otherwise necessary to gain approval of
a new drug application (NDA).
    Section 505(j)(7) of the FD&C Act requires FDA to publish a list of
all approved drugs. FDA publishes this list as part of the ``Approved
Drug Products With Therapeutic Equivalence Evaluations,'' which is
known generally as the ``Orange Book.'' Under FDA regulations, drugs
are removed from the list if the Agency withdraws or suspends approval
of the drug's NDA or ANDA for reasons of safety or effectiveness or if
FDA determines that the listed drug was withdrawn from sale for reasons
of safety or effectiveness (21 CFR 314.162).
    A person may petition the Agency to determine, or the Agency may
determine on its own initiative, whether a listed drug was withdrawn
from sale for reasons of safety or effectiveness. This determination
may be made at any time after the drug has been withdrawn from sale,
but must be made prior to approving an ANDA that refers to the listed
drug (Sec.  314.161 (21 CFR 314.161)). FDA may not approve an ANDA that
does not refer to a listed drug.
    Chirocaine (levobupivacaine) injection, 2.5 mg (base)/mL, 10 mL and
30 mL vials, 5 mg (base)/mL, 10 mL and 30 mL vials and 7.5 mg (base)/
mL, 10 mL and 30 mL vials, is the subject of NDA 020997, held by Purdue
Pharma L.P., and initially approved on August 5, 1999. Chirocaine is
indicated to produce local or regional anesthesia for surgery and
obstetrics, and for post-operative pain management.
    In a letter dated May 21, 2004, Purdue Pharma L.P. requested
withdrawal of NDA 020997 for Chirocaine (levobupivacaine) injection,
2.5 mg (base)/mL, 10 mL and 30 mL vials, 5 mg (base)/mL, 10 mL and 30
mL vials and 7.5 mg (base)/mL, 10 mL and 30 mL vials. In the Federal
Register of March 4, 2005 (70 FR 10651), FDA announced that it was
withdrawing approval of NDA 020997, effective April 4, 2005. Chirocaine
is currently listed in the ``Discontinued Drug Product List'' section
of the Orange Book.
    Lachman Consultant Services, Inc. submitted a citizen petition
dated December 21, 2022 (Docket No. FDA-2022-P-3293), under 21 CFR
10.30, requesting that the Agency determine whether Chirocaine
(levobupivacaine) injection, 2.5 mg (base)/mL, 10 mL and 30 mL vials, 5
mg (base)/mL, 10 mL and 30 mL vials and 7.5 mg (base)/mL, 10 mL and 30
mL vials, were withdrawn from sale for reasons of safety or efficacy.
    After considering the citizen petition and reviewing Agency records
and based on the information we have at this time, FDA has determined
under Sec.  314.161 that Chirocaine (levobupivacaine) injection, 2.5 mg
(base)/mL, 10 mL and 30 mL vials, 5 mg (base)/mL, 10 mL and 30 mL vials
and 7.5 mg (base)/mL, 10 mL and 30 mL vials, were not withdrawn for
reasons of safety or effectiveness. The petitioner has identified no
data or other information suggesting that Chirocaine (levobupivacaine)
injection, 2.5 mg (base)/mL, 10 mL and 30 mL vials, 5 mg (base)/mL, 10
mL and 30 mL vials and 7.5 mg (base)/mL, 10 mL and 30 mL vials, were
withdrawn for reasons of safety or effectiveness.
    We have carefully reviewed our files for records concerning the
withdrawal of Chirocaine (levobupivacaine) injection, 2.5 mg (base)/mL,
10 mL and 30 mL vials, 5 mg (base)/mL, 10 mL and 30 mL vials and 7.5 mg
(base)/mL, 10 mL and 30 mL vials, from sale. We have also independently
evaluated relevant literature and data for possible postmarketing
adverse events. We have found no information that would indicate that
these drug products were withdrawn from sale for reasons of safety or
effectiveness.
    Accordingly, the Agency will continue to list Chirocaine
(levobupivacaine) injection, 2.5 mg (base)/mL, 10 mL and 30 mL vials, 5
mg (base)/mL, 10 mL and 30 mL vials and 7.5 mg (base)/mL, 10 mL and 30
mL vials, in the ``Discontinued Drug Product List'' section of the
Orange Book. The ``Discontinued Drug Product List'' delineates, among
other items, drug products that have been discontinued from marketing
for reasons other than safety or effectiveness. ANDAs that refer to
Chirocaine (levobupivacaine) injection, 2.5 mg (base)/mL, 10 mL and 30
mL vials, 5 mg (base)/mL, 10 mL and 30 mL vials or 7.5 mg (base)/mL, 10
mL and 30 mL vials, may be approved by the Agency as long as they meet
all other legal and regulatory requirements for the approval of ANDAs.
If FDA determines that labeling for these drug products should be
revised to meet current standards, the Agency will advise ANDA
applicants to submit such labeling.

    Dated: May 22, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-11162 Filed 5-24-23; 8:45 am]
BILLING CODE 4164-01-P