[Federal Register Volume 88, Number 134 (Friday, July 14, 2023)]
[Proposed Rules]
[Pages 45123-45126]
[FR Doc No: 2023-14945]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2023-0052]
RIN 1625-AA00

Safety Zone; Hurricanes and Tropical Storms in Captain of the
Port Zone North Carolina

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Coast Guard is proposing to establish a safety zone to be
enforced in the event of hurricanes and tropical storms in the Sector
North Carolina Captain of the Port (COTP) Zone. This action is
necessary to ensure the safety of the waters of the Sector North
Carolina COTP Zone. This proposed rulemaking would establish actions to
be completed by industry and vessels in the COTP Zone prior to landfall
of hurricanes and tropical storms threatening the State of North
Carolina.

We invite your comments on this proposed rulemaking.

DATES: Comments and related material must be received by the Coast
Guard August 14, 2023.

ADDRESSES: You may submit comments identified by docket number USCG-
2023-0052 using the Federal Decision-Making Portal at https://www.regulations.gov. See the ``Public Participation and Request for
Comments'' portion of the SUPPLEMENTARY INFORMATION section for further
instructions on submitting comments.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
proposed rulemaking, call or email Petty Officer Ken Farah, Waterways
Management Division, U.S. Coast Guard; telephone<PHONE_NUMBER>, email
[email protected].

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background, Purpose, and Legal Basis

    North Carolina has the potential to be affected by hurricanes and
tropical storms on a yearly basis, especially between the months of
June and November. The Sector North Carolina Captain of the Port (COTP)
proposes establishing a safety zone to provide for the safety of life
and for the protection of port infrastructure and of the environment
during such storms. The Coast Guard is proposing this rulemaking under
authority in 46 U.S.C. 70034.

III. Discussion of Proposed Rule

    The COTP of Sector North Carolina is proposing to establish a
safety zone to be enforced in case of hurricanes and tropical storms in
North Carolina. This action is necessary to ensure the safety of the
waters of the COTP North Carolina and it would establish actions to be
completed by local industry and vessels in the COTP zone prior to
landfall of hurricanes and tropical storms threatening the State of
North Carolina. The proposed safety zone would consist of all navigable
waters of the United States in the North Carolina COTP Zone, as defined
in 33 CFR 3.25-20. Portions of the safety zone may be activated at
different times, as conditions dictate. The proposed regulatory text
appears at the end of this document.

IV. Regulatory Analyses

    We developed this proposed rule after considering numerous statutes
and Executive orders related to rulemaking. Below we summarize our
analyses based on a number of these statutes and Executive orders, and
we discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. This NPRM has not been designated a ``significant
regulatory action,'' under Executive Order 12866. Accordingly, the NPRM
has not been reviewed by the Office of Management and Budget (OMB).
    This regulatory action determination is based on the necessity to
protect life and port infrastructure during hurricanes and tropical
storms. The scope of the regulation is narrow and will only apply when
a hurricane or tropical storm impacts the navigable waters of the
Sector North Carolina Captain of the Port Zone. These events are
infrequent and of short duration. Regulatory restrictions will be
lifted as soon as practicable following the passage of a named storm.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term, ``small
entities,'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this
proposed rule would not have a significant economic impact on a
substantial number of small entities.
    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
IV.A above, this proposed rule would not have a significant economic
impact on any vessel owner or operator.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this 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 rule would economically affect it.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this proposed rule. If the proposed rule
would affect your small business, organization, or governmental
jurisdiction and you have questions concerning its provisions or
options for compliance, please call or email the person listed in the
FOR FURTHER INFORMATION CONTACT section. The Coast Guard will not
retaliate against small entities that question or complain about this
proposed rule or any policy or action of the Coast Guard.

C. Collection of Information

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

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132
(Federalism), if it has a substantial direct effect on the States, on
the relationship between the National Government and the States, or on
the distribution of power and responsibilities among the various levels
of government. We have analyzed this proposed rule under that Order and
have determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this 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. If
you believe this proposed rule has implications for federalism or
Indian tribes, please call or email the person listed in the FOR
FURTHER INFORMATION CONTACT section.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this

proposed rule would not result in such an expenditure, we do discuss
the potential effects of this proposed rule elsewhere in this preamble.

F. Environment

    We have analyzed this proposed rule under Department of Homeland
Security Directive 023-01, Rev. 1, associated implementing
instructions, and Environmental Planning COMDTINST 5090.1 (series),
which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have made
a preliminary determination that this action is one of a category of
actions that do not individually or cumulatively have a significant
effect on the human environment. This proposed rule involves a safety
zone that would prohibit entry in certain waters of the North Carolina
COTP Zone for the duration needed to ensure safe transit of vessels and
industry post-hurricane, post-storm, and post-emergency. Normally such
actions are categorically excluded from further review under paragraph
L60(a) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01,
Rev. 1. A preliminary Record of Environmental Consideration supporting
this determination is available in the docket. For instructions on
locating the docket, see the ADDRESSES section of this preamble. We
seek any comments or information that may lead to the discovery of a
significant environmental impact from this proposed rule.

G. Protest Activities

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

V. Public Participation and Request for Comments

    We view public participation as essential to effective rulemaking
and will consider all comments and material received during the comment
period. Your comment can help shape the outcome of this rulemaking. If
you submit a comment, please include the docket number for this
rulemaking, indicate the specific section of this document to which
each comment applies, and provide a reason for each suggestion or
recommendation.
    Submitting comments. We encourage you to submit comments through
the Federal Decision-Making Portal at https://www.regulations.gov. To
do so, go to https://www.regulations.gov, type USCG-2023-0052 in the
search box and click ``Search.'' Next, look for this document in the
Search Results column, and click on it. Then click on the Comment
option. If you cannot submit your material by using https://www.regulations.gov, call or email the person in the FOR FURTHER
INFORMATION CONTACT section of this proposed rule for alternate
instructions.
    Viewing material in docket. To view documents mentioned in this
proposed rule as being available in the docket, find the docket as
described in the previous paragraph, and then select ``Supporting &
Related Material'' in the Document Type column. Public comments will
also be placed in our online docket and can be viewed by following
instructions on the https://www.regulations.gov Frequently Asked
Questions web page. Also, if you click on the Dockets tab and then the
proposed rule, you should see a ``Subscribe'' option for email alerts.
The option will notify you when comments are posted, or a final rule is
published.
    We review all comments received, but we will only post comments
that address the topic of the proposed rule. We may choose not to post
off-topic, inappropriate, or duplicate comments that we receive.
    Personal information. We accept anonymous comments. Comments we
post to https://www.regulations.gov will include any personal
information you have provided. For more about privacy and submissions
to the docket in response to this document, see DHS's eRulemaking
System of Records notice (85 FR 14226, March 11, 2020).

List of Subjects in 33 CFR Part 165

    Marine safety, Navigation, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard is
proposing to amend 33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

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

    Authority:  46 U.S.C. 70034, 70051, 70124; 33 CFR 1.05-1, 6.04-
1, 6.04-6, and 160.5; Department of Homeland Security Delegation No.
00170.1, Revision No. 01.3.

0
2. Add Sec.  165.562 to read as follows:

Sec.  165.562  Safety Zone; Hurricanes and Tropical Storms in Captain
of the Port Zone North Carolina.

    (a) Regulated Areas. All navigable waters of the United States
within Sector North Carolina COTP Zone as described in 33 CFR 3.25-20,
during specified port conditions. Port conditions and safety zone
activation may vary for different regions of the regulated area at
different times, based on storm conditions and projected track.
    (b) Definitions.
    (1) Captain of the Port means the Commander, Coast Guard Sector
North Carolina.
    (2) Representative means any Coast Guard commissioned, warrant, or
petty officer or civilian employee who has been authorized to act on
the behalf of the Captain of the Port.
    (3) Port Condition WHISKEY means a condition set by the COTP when
National Weather Service (NWS) weather advisories indicate sustained
gale force winds (39-54 mph/34-47 knots) from a tropical or hurricane
force storm are predicted to make landfall at the Port of Wilmington or
Port of Morehead City within 72 hours.
    (4) Port Condition X-RAY means a condition set by the COTP when NWS
weather advisories indicate sustained gale force winds (39-54 mph/34-47
knots) from a tropical or hurricane force storm are predicted to make
landfall at the port within 48 hours.
    (5) Port Condition YANKEE means a condition set by the COTP when
NWS weather advisories indicate that sustained gale force winds (39-54
mph/34-47 knots) from a tropical or hurricane force storm are predicted
to make landfall at the port within 24 hours.
    (6) Port Condition ZULU means a condition set by the COTP when NWS
weather advisories indicate that sustained gale force winds (39-54 mph/
34-47 knots) from a tropical or hurricane force storm are predicted to
make landfall at the port within 12 hours.
    (7) Port Condition RECOVERY means a condition set by the COTP when
NWS weather advisories indicate that sustained gale force winds (39-54
mph/34-47 knots) from a tropical or hurricane force storm are no longer
predicted for the designated area. This port condition remains in
effect until the regulated areas are deemed safe and reopened to normal
operations.
    (c) Regulations.
    (1) Port Condition WHISKEY. All vessels must exercise due diligence
in preparation for potential storm impacts. Ports and waterfront
facilities are encouraged to remove all debris and secure potential
flying hazards. All self-propelled oceangoing vessels over 500 gross
tons (GT), all oceangoing tank barges and their supporting tugs, and
all tank barges over 200 GT wishing to remain in port should seek
approval

from the COTP prior to Port Condition X-Ray.
    (2) Port Condition X-RAY. All vessels and port facilities are
encouraged to ensure potential flying debris and hazardous materials
are removed or secured. All self-propelled oceangoing vessels over 500
gross tons (GT), all oceangoing tank barges and their supporting tugs,
and all tank barges over 200 GT without COTP approval to remain in port
must depart prior to the setting of Port Condition Yankee. Vessels with
COTP permission to remain in port must implement their approved mooring
arrangement.
    (3) Port Condition YANKEE. Affected ports are closed to all inbound
vessel traffic. All self-propelled oceangoing vessels over 500 gross
tons (GT), all oceangoing tank barges and their supporting tugs, and
all tank barges over 200 GT must have departed designated ports within
the Sector North Carolina COTP zone unless they have received COTP
approval to remain in port.
    (4) Port Condition ZULU. Affected ports and waterways are closed to
all vessel traffic unless specifically authorized by the COTP or
representative. Cargo operations are suspended, including bunkering and
lightering. The COTP may grant cargo transfer waivers unless a Cargo of
Particular Hazard or Certain Dangerous Cargo is involved.
    (5) Port Condition RECOVERY. Designated areas are closed to all
commercial traffic and recreational vessels 65-feet in length and
greater. Based on assessments of channel conditions, navigability
concerns, and hazards to navigation, the COTP may permit vessel
movements with restrictions. Restrictions may include, but are not
limited to, preventing or delaying vessel movements, imposing draft,
speed, size, horsepower or daylight restrictions, or directing the use
of specific routes. Vessels permitted to transit the regulated area
shall comply with the lawful orders or directions given by the COTP or
designated representative.
    (6) Safety Zones Notice. Coast Guard Sector North Carolina will
attempt to notify the maritime community of periods during which these
safety zones will be in effect via Broadcast Notice to Mariners, Marine
Safety Information Broadcast, or by on-scene designated
representatives.
    (7) Regulated Area Notice. The Coast Guard will provide notice of
the regulated area via Broadcast Notice to Mariners, Marine Safety
Information Broadcast, or by on-scene designated representatives.
    (8) Exception. This regulation does not apply to authorized law
enforcement agencies operating within the regulated area.

    Dated: June 29, 2023.
Timothy J. List,
Captain, U.S. Coast Guard, Captain of the Port, Sector North Carolina.
[FR Doc. 2023-14945 Filed 7-13-23; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 88, Number 245 (Friday, December 22, 2023)]
[Notices]
[Pages 88627-88629]
[FR Doc No: 2023-28244]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-E-3287]

Determination of Regulatory Review Period for Purposes of Patent
Extension; Copiktra

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for Copiktra and is publishing
this notice of that determination as required by law. FDA has made the
determination because of the submission of an application to the
Director of the U.S. Patent and Trademark Office (USPTO), Department of
Commerce, for the extension of a patent which claims that human drug
product.

DATES: Anyone with knowledge that any of the dates as published (see
SUPPLEMENTARY INFORMATION) are incorrect may submit either electronic
or written comments and ask for a redetermination by February 20, 2024.
Furthermore, any interested person may petition FDA for a determination
regarding whether the applicant for extension acted with due diligence
during the regulatory review period by June 20, 2024. See ``Petitions''
in the SUPPLEMENTARY INFORMATION section for more information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of February 20, 2024. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received on or before that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2019-E-3287 for ``Determination of

Regulatory Review Period for Purposes of Patent Extension; COPIKTRA.''
Received comments, those filed in a timely manner (see ADDRESSES), will
be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with Sec.  10.20 (21 CFR 10.20) and
other applicable disclosure law. For more information about FDA's
posting of comments to public dockets, see 80 FR 56469, September 18,
2015, or access the information at:: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug or biologic product, animal drug product, medical device,
food additive, or color additive) was subject to regulatory review by
FDA before the item was marketed. Under these acts, a product's
regulatory review period forms the basis for determining the amount of
extension an applicant may receive.
    A regulatory review period consists of two periods of time: a
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of USPTO may award
(for example, half the testing phase must be subtracted as well as any
time that may have occurred before the patent was issued), FDA's
determination of the length of a regulatory review period for a human
drug product will include all of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human drug product, Copiktra
(duvelisib), which is indicated for the treatment of adult patients
with:
     Relapsed or refractory chronic lymphocytic leukemia or
small lymphocytic lymphoma after at least two prior therapies.
     Relapsed or refractory follicular lymphoma after at least
two prior systemic therapies.
    This indication is approved under accelerated approval based on
overall response rate. Continued approval for this indication may be
contingent upon verification and description of clinical benefit in
confirmatory trials.
    Subsequent to this approval, the USPTO received a patent term
restoration application for Copiktra (U.S. Patent No. 8,193,182) from
Verastem, Inc., and the USPTO requested FDA's assistance in determining
the patent's eligibility for patent term restoration. In a letter dated
November 29, 2019, FDA advised the USPTO that this human drug product
had undergone a regulatory review period and that the approval of
Copiktra represented the first permitted commercial marketing or use of
the product. Thereafter, the USPTO requested that FDA determine the
product's regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
Copiktra is 2,596 days. Of this time, 2,364 days occurred during the
testing phase of the regulatory review period, while 232 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective:
August 18, 2011. The applicant claims August 21, 2011, as the date the
investigational new drug application (IND) became effective. However,
FDA records indicate that the IND effective date was August 18, 2011,
which was the first date after receipt of the IND that the
investigational studies were allowed to proceed.
    2. The date the application was initially submitted with respect to
the human drug product under section 505 of the FD&C Act: February 5,
2018. FDA has verified the applicant's claim that the new drug
application (NDA) for Copiktra (NDA 211155) was initially submitted on
February 5, 2018.
    3. The date the application was approved: September 24, 2018. FDA
has verified the applicant's claim that NDA 211155 was approved on
September 24, 2018.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its application for patent extension,
this applicant seeks 954 days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec.  60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec.  60.30, including but not limited to:

must be timely (see DATES), must be filed in accordance with Sec.
10.20, must contain sufficient facts to merit an FDA investigation, and
must certify that a true and complete copy of the petition has been
served upon the patent applicant. (See H. Rept. 857, part 1, 98th
Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format
specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: December 18, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-28244 Filed 12-21-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: August 13, 2008 (Volume 73, Number 157)]
[Notices]
[Page 47143]
[DOCID:fr13au08-54]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER08-1294-000]

Crystal Lake Wind II, LLC; Supplemental Notice That Initial
Market-Based Rate Filing Includes Request for Blanket Section 204
Authorization

August 6, 2008.
    This is a supplemental notice in the above-referenced proceeding of
Crystal Lake Wind II, LLC's application for market-based rate
authority, with an accompanying rate schedule, noting that such
application includes a request for blanket authorization, under 18 CFR
part 34, of future issuances of securities and assumptions of
liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426, in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214). Anyone filing a motion to intervene or protest must serve a
copy of that document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is August 26, 2008.
    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-referenced proceeding 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. E8-18667 Filed 8-12-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: November 28, 2007 (Volume 72, Number 228)]
[Notices]
[Page 67336-67337]
[DOCID:fr28no07-80]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Agency Information Collection Activity Seeking OMB Approval

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION:  Notice.

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SUMMARY: The FAA invites public comments about our intention to request
the Office of Management and Budget's (OMB) revision of a current
information collection. The Federal Register Notice with a 60-day
comment period soliciting comments on the following collection of
information was published on August 15, 2007, vol. 72, no. 157, page
45862-45863. Feedback from this survey is used in the prevention of
runway collisions and in the Department of the severity and frequency
of runway incursions.

DATES:  Please submit comments by December 28, 2007.

FOR FURTHER INFORMATION CONTACT:  Carla Mauney at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Federal Aviation Administration (FAA)

    Title: Information for the Prevention of Aircraft Collisions on
Runways at Towered Airports.
    Type of Request: Revision of a currently approved collection.
    OMB Control Number: 2120-0692.
    Forms(s): There are no FAA forms associated with this collection.
    Affected Public: An estimated 10,000 Respondents.
    Frequency: This information is collected on occasion.
    Estimated Average Burden Per Response: Approximately 10 minutes per
response.
    Estimated Annual Burden Hours: An estimated 1,667 hours annually.
    Abstract: Runway incursions are a risk to the public traveling in
aircraft. Feedback from this survey is used in the prevention of runway
collisions and in the Department of the severity and frequency of
runway incursions.

ADDRESSES:  Interested persons are invited to submit written comments
on the proposed information collection to the Office of Information and
Regulatory

Affairs, Office of Management and Budget. Comments should be addressed
to Nathan Lesser, Desk Officer, Department of Transportation/FAA, and
sent via electronic mail to<EMAIL_ADDRESS>or faxed to
(202) 395-6974.
    Comments are invited on: Whether the proposed collection of
information is necessary for the proper performance of the functions of
the Department, including whether the information will have practical
utility; the accuracy of the Department's estimates of the burden of
the proposed information collection; ways to enhance the quality,
utility, and clarity of the information to be collected; and ways to
minimize the burden of the collection of information on respondents,
including the use of automated collection techniques or other forms of
information technology.

    Dated: Issued in Washington, DC, on November 20, 2007.
Carla Mauney,
FAA Information Collection Clearance Officer, IT Enterprises Business
Services Division, AES-200.
[FR Doc. 07-5849 Filed 11-27-07; 8:45 am]

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[Federal Register Volume 86, Number 120 (Friday, June 25, 2021)]
[Rules and Regulations]
[Pages 33501-33503]
[FR Doc No: 2021-13469]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 97

[Docket No. 31373; Amdt. No. 3959]

Standard Instrument Approach Procedures, and Takeoff Minimums and
Obstacle Departure Procedures; Miscellaneous Amendments

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This rule establishes, amends, suspends, or removes Standard
Instrument Approach Procedures (SIAPS) and associated Takeoff Minimums
and Obstacle Departure procedures (ODPs) for operations at certain
airports. These regulatory actions are needed because of the adoption
of new or revised criteria, or

because of changes occurring in the National Airspace System, such as
the commissioning of new navigational facilities, adding new obstacles,
or changing air traffic requirements. These changes are designed to
provide safe and efficient use of the navigable airspace and to promote
safe flight operations under instrument flight rules at the affected
airports.

DATES: This rule is effective June 25, 2021. The compliance date for
each SIAP, associated Takeoff Minimums, and ODP is specified in the
amendatory provisions.
    The incorporation by reference of certain publications listed in
the regulations is approved by the Director of the Federal Register as
of June 25, 2021.

ADDRESSES: Availability of matters incorporated by reference in the
amendment is as follows:

For Examination

    1. U.S. Department of Transportation, Docket Ops-M30. 1200 New
Jersey Avenue SE, West Bldg., Ground Floor, Washington, DC, 20590-0001.
    2. The FAA Air Traffic Organization Service Area in which the
affected airport is located;
    3. The office of Aeronautical Information Services, 6500 South
MacArthur Blvd., Oklahoma City, OK 73169 or,
    4. The National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, email
<EMAIL_ADDRESS>or go to: https://www.archives.gov/federal-register/cfr/ibr-locations.html.

Availability

    All SIAPs and Takeoff Minimums and ODPs are available online free
of charge. Visit the National Flight Data Center at nfdc.faa.gov to
register. Additionally, individual SIAP and Takeoff Minimums and ODP
copies may be obtained from the FAA Air Traffic Organization Service
Area in which the affected airport is located.

FOR FURTHER INFORMATION CONTACT: Thomas J. Nichols, Flight Procedures
and Airspace Group, Flight Technologies and Procedures Division, Flight
Standards Service, Federal Aviation Administration. Mailing Address:
FAA Mike Monroney Aeronautical Center, Flight Procedures and Airspace
Group, 6500 South MacArthur Blvd., Registry Bldg. 29, Room 104,
Oklahoma City, OK 73169. Telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: This rule amends 14 CFR part 97 by
establishing, amending, suspending, or removes SIAPS, Takeoff Minimums
and/or ODPS. The complete regulatory description of each SIAP and its
associated Takeoff Minimums or ODP for an identified airport is listed
on FAA form documents which are incorporated by reference in this
amendment under 5 U.S.C. 552(a), 1 CFR part 51, and 14 CFR part 97.20.
The applicable FAA Forms 8260-3, 8260-4, 8260-5, 8260-15A, 8260-15B,
when required by an entry on 8260-15A, and 8260-15C.
    The large number of SIAPs, Takeoff Minimums and ODPs, their complex
nature, and the need for a special format make publication in the
Federal Register expensive and impractical. Further, airmen do not use
the regulatory text of the SIAPs, Takeoff Minimums or ODPs, but instead
refer to their graphic depiction on charts printed by publishers or
aeronautical materials. Thus, the advantages of incorporation by
reference are realized and publication of the complete description of
each SIAP, Takeoff Minimums and ODP listed on FAA form documents is
unnecessary. This amendment provides the affected CFR sections and
specifies the typed of SIAPS, Takeoff Minimums and ODPs with their
applicable effective dates. This amendment also identifies the airport
and its location, the procedure, and the amendment number.

Availability and Summary of Material Incorporated by Reference

    The material incorporated by reference is publicly available as
listed in the ADDRESSES section.
    The material incorporated by reference describes SIAPS, Takeoff
Minimums and/or ODPs as identified in the amendatory language for part
97 of this final rule.

The Rule

    This amendment to 14 CFR part 97 is effective upon publication of
each separate SIAP, Takeoff Minimums and ODP as amended in the
transmittal. Some SIAP and Takeoff Minimums and textual ODP amendments
may have been issued previously by the FAA in a Flight Data Center
(FDC) Notice to Airmen (NOTAM) as an emergency action of immediate
flights safety relating directly to published aeronautical charts.
    The circumstances that created the need for some SIAP and Takeoff
Minimums and ODP amendments may require making them effective in less
than 30 days. For the remaining SIAPs and Takeoff Minimums and ODPs, an
effective date at least 30 days after publication is provided.
    Further, the SIAPs and Takeoff Minimums and ODPs contained in this
amendment are based on the criteria contained in the U.S. Standard for
Terminal Instrument Procedures (TERPS). In developing these SIAPs and
Takeoff Minimums and ODPs, the TERPS criteria were applied to the
conditions existing or anticipated at the affected airports. Because of
the close and immediate relationship between these SIAPs, Takeoff
Minimums and ODPs, and safety in air commerce, I find that notice and
public procedure under 5 U.S.C. 553(b) are impracticable and contrary
to the public interest and, where applicable, under 5 U.S.C. 553(d),
good cause exists for making some SIAPs effective in less than 30 days.
    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.
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. For the same reason, the FAA
certifies that this amendment will not have a significant economic
impact on a substantial number of small entities under the criteria of
the Regulatory Flexibility Act.

Lists of Subjects in 14 CFR Part 97

    Air Traffic Control, Airports, Incorporation by reference,
Navigation (Air).

    Issued in Washington, DC, on May 28, 2021.
Wade E.K. Terrell,
Aviation Safety, Flight Standards Service, Manager (A), Flight
Technologies and Procedures Division.

Adoption of the Amendment

    Accordingly, pursuant to the authority delegated to me, Title 14,
Code of Federal Regulations, Part 97 (14 CRF part 97) is amended by
establishing, amending, suspending, or removing Standard Instrument
Approach Procedures and/or Takeoff Minimums and Obstacle Departure
Procedures effective at 0901 UTC on the dates specified, as follows:

PART 97--STANDARD INSTRUMENT APPROACH PROCEDURES

0
1. The authority citation for part 97 continues to read as follows:

    Authority:  49 U.S.C. 106(f), 106(g), 40103, 40106, 40113,
40114, 40120, 44502, 44514, 44701, 44719, 44721-44722.

0
2. Part 97 is amended to read as follows:

Effective 15 July 2021

Orlando, FL, KMCO, ILS OR LOC RWY 17L, ILS RWY 17L (SA CAT I), ILS
RWY 17L (CAT II), ILS RWY 17L (CAT III), Amdt 4A
Orlando, FL, KMCO, RNAV (GPS) RWY 17L, Amdt 2A

Effective 12 August 2021

Koyuk, AK, PAKK, RNAV (GPS) RWY 1, Amdt 1A
Pago Pago, AS, Pago Pago Intl, ILS OR LOC RWY 5, Amdt 15
Pago Pago, AS, Pago Pago Intl, NDB-C, Amdt 6C, CANCELLED
Pago Pago, AS, Pago Pago Intl, VOR-D, Amdt 6B, CANCELLED
Pago Pago, AS, Pago Pago Intl, VOR OR TACAN-A, Amdt 4B, CANCELLED
Pago Pago, AS, Pago Pago Intl, VOR OR TACAN-B, Amdt 6B
Mesa, AZ, KFFZ, RNAV (GPS) RWY 4L, Amdt 1D
Mesa, AZ, KFFZ, RNAV (GPS) RWY 4R, Amdt 1F
Mesa, AZ, KFFZ, RNAV (GPS)-B, Amdt 1
Cloverdale, CA, O60, RNAV (GPS) RWY 32. Amdt 1
Napa, CA, KAPC, RNAV (GPS) RWY 6, Amdt 2
Novato, CA, KDVO, RNAV (GPS) RWY 13, Amdt 1
Windsor Locks, CT, KBDL, ILS OR LOC RWY 24, ILS RWY 24 (SA CAT I),
ILS RWY 24 (SA CAT II), Amdt 13A
Windsor Locks, CT, KBDL, ILS OR LOC RWY 33, Amdt 10D
Windsor Locks, CT, KBDL, RNAV (GPS) RWY 15, Amdt 4A
Windsor Locks, CT, KBDL, RNAV (GPS) RWY 33, Amdt 3A
Windsor Locks, CT, KBDL, RNAV (GPS) Y RWY 6, Amdt 3A
Windsor Locks, CT, KBDL, RNAV (GPS) Y RWY 24, Amdt 4B
Windsor Locks, CT, Bradley Intl, Takeoff Minimums and Obstacle DP,
Amdt 5
Fort Lauderdale, FL, KFLL, ILS OR LOC RWY 28R, Amdt 12
Fort Lauderdale, FL, KFLL, RNAV (GPS) Y RWY 28R, Amdt 5
Fort Lauderdale, FL, KFLL, RNAV (RNP) Z RWY 28R, Amdt 2
Orlando, FL, KISM, VOR/DME-A, Amdt 1, CANCELLED
Atlanta, GA, KATL, ILS OR LOC RWY 27R, Amdt 7
Atlanta, GA, KATL, ILS PRM RWY 27R (CLOSE PARALLEL), Amdt 3
Mc Rae, GA, KMQW, NDB RWY 21, Amdt 10A, CANCELLED
Thomaston, GA, Thomaston-Upson County, Takeoff Minimums and Obstacle
DP, Amdt 2A
Dubuque, IA, KDBQ, LOC/DME BC RWY 13, Amdt 5D, CANCELLED
Pocahontas, IA, KPOH, NDB RWY 12, Amdt 5D, CANCELLED
Winterset, IA, 3Y3, RNAV (GPS) RWY 14, Amdt 1A
Winterset, IA, 3Y3, RNAV (GPS) RWY 32, Amdt 1B
Monmouth, IL, C66, RNAV (GPS)-A, Orig
Monmouth, IL, C66, VOR OR GPS-A, Amdt 4, CANCELLED
Savanna, IL, Tri-Township, Takeoff Minimums and Obstacle DP, Orig-A
Huntingburg, IN, KHNB, RNAV (GPS) RWY 9, Amdt 1
Huntingburg, IN, KHNB, RNAV (GPS) RWY 27, Amdt 1
Huntingburg, IN, Huntingburg, Takeoff Minimums and Obstacle DP, Amdt
2
Logansport, IN, Logansport/Cass County, Takeoff Minimums and
Obstacle DP, Amdt 2
Norton, KS, KNRN, RNAV (GPS) RWY 34, Amdt 2
Monroe, LA, Monroe Rgnl, ILS OR LOC RWY 22, Amdt 4C
Monroe, LA, Monroe Rgnl, RNAV (GPS) RWY 22, Amdt 2
Monroe, LA, KMLU, RNAV (GPS) RWY 32, Amdt 1
Monroe, LA, Monroe Rgnl, Takeoff Minimums and Obstacle DP, Amdt 6
Monroe, LA, Monroe Rgnl, VOR RWY 22, Amdt 10
Monroe, LA, KMLU, VOR RWY 32, Amdt 5
Shreveport, LA, KSHV, ILS OR LOC RWY 14, ILS RWY 14 (CAT II), Amdt
26B
Shreveport, LA, KSHV, ILS OR LOC RWY 32, Amdt 6B
Shreveport, LA, KSHV, RNAV (GPS) RWY 14, Amdt 2C
Shreveport, LA, KSHV, RNAV (GPS) RWY 24, Amdt 2C
Shreveport, LA, KSHV, RNAV (GPS) RWY 32, Amdt 2B
Orange, MA, KORE, VOR-A, Amdt 8
Menominee, MI, KMNM, RNAV (GPS) RWY 32, Amdt 1D
Mountain View, MO, KMNF, RNAV (GPS) RWY 28, Orig-D
Rolla/Vichy, MO, KVIH, RNAV (GPS) RWY 4, Orig-B
Washington, MO, KFYG, RNAV (GPS) RWY 33, Amdt 2A
Burlington, NC, KBUY, ILS Z OR LOC Z RWY 6, Amdt 2C
Ogallala, NE, KOGA, VOR RWY 26, Amdt 1E
Ely, NV, KELY, RNAV (GPS) RWY 18, Amdt 1B
Ely, NV, KELY, VOR-C, Amdt 2A
Farmingdale, NY, KFRG, NDB RWY 1, Amdt 14D, CANCELLED
Farmingdale, NY, KFRG, RNAV (GPS) RWY 1, Amdt 3
Farmingdale, NY, KFRG, RNAV (GPS) RWY 19, Amdt 3
Farmingdale, NY, KFRG, RNAV (GPS) RWY 32, Amdt 1
Johnstown, NY, NY0, NDB RWY 10, Amdt 2, CANCELLED
Johnstown, NY, NY0, NDB RWY 28, Amdt 2, CANCELLED
Rome, NY, KRME, ILS OR LOC RWY 33, Amdt 3
Syracuse, NY, KSYR, VOR RWY 15, Amdt 23D
Cleveland, OH, KBKL, RNAV (GPS) RWY 24R, Amdt 1
Wilmington, OH, KILN, RNAV (GPS) RWY 22R, Orig-D
Pauls Valley, OK, Pauls Valley Muni, Takeoff Minimums and Obstacle
DP, Orig-A
Florence, SC, Florence Rgnl, Takeoff Minimums and Obstacle DP, Amdt
5A
Knoxville, TN, KTYS, ILS OR LOC RWY 5L, Amdt 10
Knoxville, TN, KTYS, ILS OR LOC RWY 23R, ILS RWY 23R (SA CAT I), ILS
RWY 23R (CAT II), Amdt 14
Knoxville, TN, KTYS, RADAR-1, Amdt 23
Knoxville, TN, KTYS, RNAV (GPS) RWY 5L, Amdt 3
Knoxville, TN, KTYS, RNAV (GPS) RWY 23R, Amdt 3
Knoxville, TN, Mc Ghee Tyson, Takeoff Minimums and Obstacle DP, Amdt
9
Knoxville, TN, KTYS, VOR RWY 23R, Amdt 8
Austin, TX, KHYI, ILS OR LOC RWY 13, Amdt 6D
Austin, TX, KHYI, NDB RWY 13, Amdt 5C
Austin, TX, KHYI, RNAV (GPS) RWY 13, Amdt 2C
Houston, TX, KIAH, ILS OR LOC RWY 27, ILS RWY 27 (SA CAT I), ILS RWY
27 (CAT II), ILS RWY 27 (CAT III), Amdt 11D
Midland, TX, KMDD, RNAV (GPS) RWY 34, Orig-B
Palestine, TX, KPSN, NDB RWY 36, Amdt 8A, CANCELLED
Rockwall, TX, F46, NDB-A, Orig-C, CANCELLED
Juneau, WI, Dodge County, Takeoff Minimums and Obstacle DP, Orig-A
Land O'Lakes, WI, KLNL, RNAV (GPS) RWY 32, Orig-D

[FR Doc. 2021-13469 Filed 6-24-21; 8:45 am]
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