[Federal Register Volume 86, Number 124 (Thursday, July 1, 2021)]
[Rules and Regulations]
[Pages 34961-34963]
[FR Doc No: 2021-14130]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2021-0438]
RIN 1625-AA00

Safety Zone; Ohio River, New Richmond

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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

SUMMARY: The Coast Guard is The Coast Guard is establishing a temporary
safety zone for all navigable waters of the Ohio River, extending the
entire width of the river, at mile marker (MM) 450.0. This safety zone
is necessary to provide for the safety of life on these navigable
waters near New Richmond, Ohio during the New Richmond Fireworks. Entry
of vessels or persons into this zone is prohibited unless specifically
authorized by the Captain of the Port Ohio Valley.

DATES: This rule is effective on July 4, 2021 from 10 p.m. through
10:30 p.m.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to https://www.regulations.gov, type USCG-
2021-0438 in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT:  If you have questions on this rule,
call or email Petty Officer Matthew Roberts, Marine Safety Detachment
Cincinnati, U.S. Coast Guard; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>
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 Information and Regulatory History

    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because it is impracticable. We must
establish this regulation by July 4, 2021 and lack sufficient time to
provide a reasonable comment period and then consider those comments
before issuing this rule.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Delaying the effective date of
this rule would be impracticable and contrary to the public interest
because immediate action is necessary to protect persons and property
from the dangers associated with the event.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 33 U.S.C.
1233. The Captain of the Port Sector Ohio Valley (COTP) has determined
that potential hazards associated with the New Richmond Fireworks,
occurring on July 4, 2021 from 10 p.m. through 10:30 p.m., will be a
safety concern for all navigable waters on the Ohio River, extending
the entire width of the river, at mile marker (MM) 450.0. The purpose
of this rule is to ensure the safety of life and vessels on these
navigable waters before, during, and after the scheduled event.

IV. Discussion of the Rule

    This rule establishes a safety zone on July 4, 2021 from 10 p.m.
through 10:30 p.m. on all navigable waters of the Ohio River, extending
the entire width of the river, at MM 450.0. Transit into and through
this area is prohibited during periods of enforcement on these dates
and times. The periods of enforcement will be prior to, during, and 30
minutes after any vessel movement and during the fireworks display. The
Coast Guard was informed that the operations will take place from 10
p.m. through 10:30 p.m. Enforcement of the regulated area will occur
during the fireworks display. The duration of the safety zone is
intended to ensure the safety of life and vessels on these navigable
waters before, during, and after the scheduled event. No vessel or
person will be permitted to enter the safety zone without obtaining
permission from the COTP or a designated representative. A designated
representative is a commissioned, warrant, or petty officer of the U.S.
Coast Guard assigned to units under the operational control of Sector
Ohio Valley. They may be contacted on VHF-FM Channel 16 or by telephone
at 1-800-253-7465. Persons and vessels permitted to enter this
regulated area must transit at their slowest safe speed and comply with
all lawful directions issued by the COTP or the designated
representative.

V. Regulatory Analyses

    We developed this 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 rule has not been designated a ``significant
regulatory action,'' under

Executive Order 12866. Accordingly, this rule has not been reviewed by
the Office of Management and Budget (OMB).
    This regulatory action determination is based on the size,
location, duration, and time-of-day of the safety zone. This safety
zone will be in place at Mile Marker 450 Ohio River on July 4, 2021
from 10 p.m. through 10:30 p.m. The Coast Guard will issue written
Local Notice to Mariners and Broadcast Notice to Mariners via VHF-FM
marine channel 16 about the temporary safety zone, and this rule also
allows vessels to seek permission from the COTP or a designated
representative to enter the area.

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 rule
will 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 V.
A. above, this rule will not have a significant economic impact on any
vessel owner or operator.
    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 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
call or email the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

    This rule will 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 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 rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does 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.

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

F. Environment

    We have analyzed this 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 determined 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 rule involves the
establishment of a safety zone lasting thirty minutes that prohibits
entry on all navigable waters of the Ohio River at MM 450. It is
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
Record of Environmental Consideration supporting this determination is
available in the docket where indicated under ADDRESSES.

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.

List of Subjects in 33 CFR Part 165

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

    For the reasons discussed in the preamble, the Coast Guard amends
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; 33 CFR 1.05-1, 6.04-1, 6.04-
6, and 160.5; Department of Homeland Security Delegation No. 0170.1.

0
2. Add Sec.  165.T08-0438 to read as follows:

Sec.  165.T08-0438  Safety zone; Ohio River, New Richmond, OH.

    (a) Location. All navigable waters of the Ohio River at MM 450 New
Richmind, Ohio.
    (b) Period of enforcement. This temporary safety zone will be
enforced on July 4, 2021 from 10 p.m. until 10:30 p.m.
    (c) Regulations. (1) In accordance with the general regulations in
Sec.  165.23 of this part, entry into this zone is prohibited unless
specifically authorized by the Captain of the Port Sector Ohio Valley
(COTP) or a designated representative. Persons or vessels desiring to
enter into or pass through the zone must request permission from the
COTP or a designated representative. They may be contacted on VHF-FM
radio channel 16 or phone at 1-800-253-7465.
    (2) Persons and vessels permitted to deviate from this safety zone
regulation and enter the restricted area must transit at the slowest
safe speed and comply

with all lawful directions issued by the COTP or a designated
representative.
    (d) Informational broadcasts. The COTP or a designated
representative will inform the public through broadcast notices to
mariners of the enforcement period for the temporary safety zone as
well as any changes in the planned schedule.

    Dated: June 27, 2021.
A.M. Beach,
Captain, U.S. Coast Guard, Captain of the Port Sector Ohio Valley.
[FR Doc. 2021-14130 Filed 6-30-21; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 88, Number 235 (Friday, December 8, 2023)]
[Notices]
[Pages 85633-85635]
[FR Doc No: 2023-26982]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-E-0248]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for ZYNLONTA 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
biological product.

DATES: Anyone with knowledge that any of the dates as published (see
SUPPLEMENTARY INFORMATION) are incorrect must submit either electronic
or written comments and ask for a redetermination by February 6, 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 5, 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 6, 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-2022-E-0248 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; ZYNLONTA.'' 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, 240-
402-7500.
     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 biological 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 biological products, the
testing phase begins when the exemption to permit the clinical
investigations of the biological product becomes effective and runs
until the approval phase begins. The approval phase starts with the
initial submission of an application to market the human biological
product and continues until FDA grants permission to market the
biological 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 biological 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 biologic product ZYNLONTA
(loncastuximab tesirine-lpyl). ZYNLONTA is indicated for the treatment
of adult patients with relapsed or refractory large B-cell lymphoma
after two or more lines of systemic therapy, including diffuse large B-
cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from low
grade lymphoma, and high-grade B-cell lymphoma. Subsequent to this
approval, the USPTO received a patent term restoration application for
ZYNLONTA (U.S. Patent No. 9,931,414) from ADC Therapeutics S.A., and
the USPTO requested FDA's assistance in determining this patent's
eligibility for patent term restoration. In a letter dated September 8,
2022, FDA advised the USPTO that this human biological product had
undergone a regulatory review period and that the approval of ZYNLONTA
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
ZYNLONTA is 1,969 days. Of this time, 1,754 days occurred during the
testing phase of the regulatory review period, while 215 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 (21 U.S.C. 355(i)) became effective: December 4, 2015.
FDA has verified the applicant's claim that the date the
investigational new drug application became effective was on December
4, 2015.
    2. The date the application was initially submitted with respect to
the human biological product under section 351 of the Public Health
Service Act (42 U.S.C. 262): September 21, 2020. FDA has verified the
applicant's claim that the biologics license application (BLA) for
ZYNLONTA (BLA 761196) was initially submitted on September 21, 2020.
    3. The date the application was approved: April 23, 2021. FDA has
verified the applicant's claim that BLA 761196 was approved on April
23, 2021.
    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 559 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 5, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-26982 Filed 12-7-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: July 29, 2008 (Volume 73, Number 146)]
[Notices]
[Page 43924-43926]
[DOCID:fr29jy08-36]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. PF07-13-000]

Palomar Gas Transmission, LLC; Supplemental Notice of Intent To
Prepare an Environmental Impact Statement for the Proposed Palomar Gas
Transmission Project and Request for Comments on Environmental Issues
Related to an Alternative Pipeline Route Under Consideration

July 18, 2008.
    The staff of the Federal Energy Regulatory Commission (FERC or
Commission) is preparing an environmental impact statement (EIS) that
will discuss the environmental impacts of the Palomar Gas Transmission
Project that could result from the construction and operation of a new
underground natural gas pipeline proposed by the Palomar Gas
Transmission, LLC (PGT). This notice explains the scoping process that
will be used to gather input from the public and interested agencies on
the project. Your input will help determine which issues need to be
evaluated in the EIS. Please note that the scoping period for the
project will close on August 18, 2008. This is not your only
opportunity to provide comments. Please refer to the Pre-filing
Environmental Review Process flow chart in Appendix 1 for future public
input opportunities.
    An initial Notice of Intent (NOI) for this Project was issued by
the FERC on October 29, 2007. Since that time, PGT has been requested
by the City of Molalla to consider an alternative route south of the
City's study area for potential future expansion of the urban growth
boundary. This route would also facilitate a horizontal directional
drilling (HDD) crossing of the Molalla River. With this NOI, we \1\ are
specifically requesting comments on this alternative, referred to as
the Herman Road Alternative.
---------------------------------------------------------------------------

    \1\ ``We,'' ``us,'' and ``our'' refer to the environmental staff
of the FERC's Office of Energy Projects.
---------------------------------------------------------------------------

    Comments may be submitted in written form or verbally. In lieu of,
or in addition to, sending written comments, you are invited to attend
a public scoping meeting that has been scheduled in the project area.
This meeting is scheduled to be held at 7 p.m. on August 5, 2008, at
the Molalla High School Commons in Molalla, Oregon. Further
instructions on how to submit comments and additional details of the
public scoping meetings are provided in the public participation
section of this notice.
    The FERC is the lead federal agency in the preparation of the EIS,
and is preparing the EIS to satisfy the requirements of the National
Environmental Policy Act (NEPA). The Commission will use the EIS in its
decision-making processes to determine whether or not to authorize the
Project.
    This NOI is being sent to landowners affected by the current
proposed route; landowners affected by the Herman Road Alternative;
federal, state, and local government agencies; elected officials;
environmental and public interest groups; Native American tribes; other
interested parties; and local libraries and newspapers. We encourage
government representatives to notify their constituents of this planned
Project and encourage them to comment on their areas of concern.
    If you are a landowner receiving this notice, you may be contacted
by a PGT representative about the acquisition of an easement to
construct, operate, and maintain the proposed Project facilities.
Depending on the alternative selected as the certificated route, PGT
would seek to negotiate a mutually acceptable agreement. However, if
the Project is approved by the FERC, that approval conveys with it the
right of eminent domain. Therefore, if easement negotiations fail to
produce an agreement, the pipeline company could initiate condemnation
proceedings in accordance with state law.
    A number of fact sheets prepared by the FERC, including ``An
Interstate Natural Gas Facility On My Land? What Do I Need To Know?''
and ``Guide to Electronic Information at FERC,'' are available for
viewing on the FERC Internet Web site (www.ferc.gov), using the ``For
Citizens'' link. These fact sheets address a number of typically asked
questions including how to participate in the Commission's proceedings
and how to access information on FERC-regulated projects in your area.

Involvement of Other Agencies

    The U.S. Department of Agriculture, Forest Service, the Bureau of
Land Management, and the U.S. Army Corps of Engineers have agreed to
participate as cooperating agencies in the preparation of the EIS to
satisfy their respective NEPA responsibilities.

Summary of the Proposed Project

    PGT has announced its proposal to construct and operate a new
natural gas pipeline and associated structures with a bi-directional
flow capacity of 1.4 billion cubic feet per day. The project would be
located in northwest Oregon and consist of a 211-mile-long, 36-inch-
diameter pipeline running from near Shaniko, Wasco County, Oregon, to
the Bradwood sendout pipeline in Clatsop County, Oregon. The pipeline
would travel across Wasco, Clackamas, Marion, Yamhill, Washington,
Columbia, and Clatsop Counties in Oregon. The pipeline would connect
the existing Gas Transmission Northwest Corporation (GTN) mainline
pipeline system in central Oregon to the Northwest Natural Gas Company
(NW Natural) distribution system near Molalla in Clackamas County. The
pipeline is also proposed to extend to other potential interconnections
with NW Natural's system and to an interconnection with NorthernStar
Energy, LLC's proposed Bradwood Landing pipeline in Clatsop County,
Oregon. The proposed project would also include a 3.8-mile-long, 36-
inch-diameter lateral pipeline \2\ near Molalla, Clackamas County,
Oregon, to connect the PGT Project mainline to an existing NW Natural
city gate. Certain associated aboveground facilities are also proposed,
i.e., mainline valves spaced at intervals along the pipeline as defined
by U.S. Department of Transportation regulations per the Code of
Federal Regulations (CFR) 49 Part 192, at least three meter stations,
and pig launcher and receiver facilities. At this time, PGT does not
anticipate that compression will be required for this project.
---------------------------------------------------------------------------

    \2\ A lateral pipeline typically takes gas from the main system
to deliver it to a customer, local distribution system, or another
interstate transmission system.
---------------------------------------------------------------------------

    More specifically, PGT proposes the following primary project
components:
     A 211-mile-long, 36-inch diameter underground natural gas
mainline consisting of two segments:
     The Cascades Segment: A 108.5-mile of mainline from
TransCanada's GTN pipeline system northwest of Madras in Wasco County
to a location southwest of Molalla in Clackamas County; and a 3.8-mile,
36-inch diameter accessory lateral pipeline, the Molalla Lateral, which
will connect the main pipeline to NW Natural's distribution system;
     The Willamette Segment: A 102.5-mile segment commencing at
the Molalla Lateral interconnect and terminating at the proposed
connection to the Bradwood Landing sendout pipeline in Clatsop County;
there is potential for additional interconnections with NW Natural
along this route;
     Two meter stations, eight mainline valves, and two pig
launchers/receivers on Segment I; one pig launcher/receiver

on the Molalla Lateral; and one meter station, seven mainline valves,
and one pig launcher/receiver on Section II;
     Temporary pipe storage and contractor yards at various
locations along the pipeline for office trailers, parking, and pipe and
equipment storage during construction; and
     Temporary construction roadways and short permanent roads
from existing roads to meter station sites and other aboveground
facilities.
    In addition, PGT is evaluating an alternative pipeline route south
of the City of Molalla's study area for potential future expansion of
the urban growth boundary, referred to as the Herman Road Alternative.
The Herman Road Alternative is approximately 5.1 miles long, or 0.2
mile longer than the corresponding current route segment and is located
adjacent to an existing right-of-way (Herman Road) for about 0.9 mile.
No addition valves, meter stations, or pig launchers/receivers would be
required if this alternative is selected.
    A map depicting PGT's proposed facilities is attached to this NOI
as Appendix 2. A map depicting the Herman Road Alternative and the
corresponding current route segment is attached to this NOI as Appendix
3.\3\
---------------------------------------------------------------------------

    \3\ The appendices referenced in this notice are not being
printed in the Federal Register. Copies can be obtained from the
Commission's Web site (excluding maps) at the ``eLibrary'' link,
from the Commission's Public Reference Room, or by calling (202)
502-8371. For instructions on connecting to eLibrary, refer to the
end of this notice. Copies of the appendices were sent to all those
receiving this notice in the mail.
---------------------------------------------------------------------------

The EIS Process

    Although no formal application has been filed with the FERC, we
have initiated our NEPA review under the FERC's Pre-Filing Process. The
purpose of the Pre-Filing Process is to encourage the early involvement
of interested stakeholders and to identify and resolve issues before an
application is filed with the FERC.
    NEPA requires the Commission to take into account the environmental
impacts that could result from an action when it considers whether or
not a natural gas pipeline should be approved. FERC will use the EIS to
consider the environmental impacts that could result if it issues
project authorizations to PGT under Sections 3 and 7 of the Natural Gas
Act. NEPA also requires us to discover and address concerns the public
may have about proposals. This process is referred to as ``scoping.''
The main goal of scoping is to focus the analysis in the EIS on the
important environmental issues. With this NOI, the Commission staff is
requesting public comments on the scope of the issues to be addressed
in the EIS. All comments received will be considered during preparation
of the EIS.
    In the EIS we will discuss impacts that could occur as a result of
the construction, operation, and maintenance of the proposed project
under these general headings:
     Geology and soils.
     Water resources.
     Aquatic resources.
     Vegetation and wildlife.
     Threatened and endangered species.
     Land use, recreation, and visual resources.
     Cultural resources.
     Socioeconomics.
     Air quality and noise.
     Reliability and safety.
     Cumulative impacts.
    In the EIS, we will also evaluate possible alternatives to the
proposed project or portions of the project (including the Herman Road
Alternative), and make recommendations on how to lessen or avoid
impacts on affected resources.
    Our independent analysis of the issues will be included in a draft
EIS. The draft EIS will be mailed to federal, state, and local
government agencies; elected officials; affected landowners;
environmental and public interest groups; Indian tribes and regional
Native American organizations; commentors; other interested parties;
local libraries and newspapers; and FERC's official service list for
this proceeding. There will be, at a minimum, a 45-day comment period
allotted for review of the draft EIS. We will consider all comments on
the draft EIS and revise the document, if necessary, before issuing a
final EIS. We will consider all comments on the final EIS before we
make our recommendations to the Commission. To ensure that your
comments are considered, please follow the instructions in the Public
Participation section of this NOI.

Public Participation

    You can make a difference by providing us with your specific
comments or concerns about the Herman Road Alternative. Your comments
should focus on the potential environmental effects, reasonable
alternatives, and measures to avoid or lessen the environmental impact
of the Herman Road Alternative. The more specific your comments, the
more useful they will be. To ensure that your comments are timely and
properly recorded, please send in you comments so that they will be
received in Washington, DC, on or before August 15, 2008.
    For your convenience, there are three methods in which you can use
to submit your comments to the Commission. In all instances please
reference the project docket number Docket No. PF07-13-000 with your
submission. The docket number can be found on the front of this notice.
The Commission encourages electronic filing of comments and has
dedicated eFiling expert staff available to assist you at<PHONE_NUMBER>
or<EMAIL_ADDRESS>    1. You may file your comments electronically by using the Quick
Comment feature, which is located on the Commission's internet Web site
at http://www.ferc.gov under the link to Documents and Filings. A Quick
Comment is an easy method for interested persons to submit text-only
comments on a project;
    2. You may file your comments electronically by using the eFiling
feature, which is located on the Commission's internet Web site at
http://www.ferc.gov under the link to Documents and Filings. eFiling
involves preparing your submission in the same manner as you would if
filing on paper, and then saving the file on your computer's hard
drive. You will attach that file as your submission. New eFiling users
must first create an account by clicking on ``Sign up'' or
``eRegister.'' You will be asked to select the type of filing you are
making. A comment on a particular project is considered a ``Comment on
a Filing;'' or
    3. You may file your comments via mail to the Commission by sending
an original and two copies of your letter to: Kimberly D. Bose,
Secretary, Federal Energy Regulatory Commission, 888 First St., NE.,
Room 1A, Washington, DC 20426;
     Label one copy of your comments for the attention of OEP/
DG2E/Gas Branch, PJ-11.2.
     Reference Docket No. PF07-13-000 on the original and both
copies.
    The scoping meeting is scheduled to be held at 7 p.m. on August 5,
2008 at: Molalla High School Commons, 357 Frances Street, Molalla, OR
97083.

Environmental Mailing List

    Everyone who provides comments on this Supplemental NOI will be
retained on the mailing list. If you do not want to send comments at
this time but still want to stay informed and receive copies of the
draft and final EISs, you must return the Mailing List Retention Form
(Appendix 4). Also, indicate on the form your preference for receiving
a

paper version of the EIS in lieu of an electronic version of the EIS on
CD-ROM. If you have previously submitted comments or returned a Mailing
List Retention Form you are already on our mailing list and do not need
to resubmit comments or a Mailing List Retention Form.

Additional Information

    Once PGT formally files its application with the Commission, you
may want to become an ``intervenor,'' which is an official party to the
proceeding. Intervenors play a more formal role in the process and are
able to file briefs, appear at hearings, and be heard by the courts if
they choose to appeal the Commission's final ruling. An intervenor
formally participates in a Commission proceeding by filing a request to
intervene. Instructions for becoming an intervenor are included in the
User's Guide under the ``e-filing'' link on the Commission's Web site.
Please note that you may not request intervenor status at this time.
You must wait until a formal application is filed with the Commission.
    Additional information about the Project is available from the
Commission's Office of External Affairs at 1-866-208 FERC (3372) or on
the FERC Internet Web site (http://www.ferc.gov) using the ``eLibrary''
link. Click on the eLibrary link, click on ``General Search,'' and
enter the docket number excluding the last three digits in the Docket
Number field (i.e., PF07-15). Be sure you have selected an appropriate
date range. For assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>or toll free at 1-866-208-3676, or for TTY,
contact<PHONE_NUMBER>. The eLibrary link on the FERC Internet Web site
also provides access to the texts of formal documents issued by the
Commission, such as Orders, notices, and rulemakings.
    In addition, the FERC now offers a free service called
eSubscription that allows you to keep track of all formal issuances and
submittals in specific dockets. This can reduce the amount of time you
spend researching proceedings by automatically providing you with
notification of these filings, document summaries, and direct links to
the documents. To register for this service, go to http://www.ferc.gov/
esubscribenow.htm.
    Public meetings or site visits will be posted on the Commission's
calendar located at http://www.ferc.gov/EventCalendar/EventsList.aspx
along with other related information.
    Finally, PGT has established a Web site for this project at http://
www.palomargas.com/project.html. The Web site includes a project
overview, timeline, safety and environmental information, and answers
to frequently asked questions. You can also request additional
information by e-mailing PGT directly at<EMAIL_ADDRESS>or writing
to: Palomar Gas Transmission, 1400 SW. Fifth Avenue, Suite 900,
Portland, Oregon 97225.

Kimberly D. Bose,
Secretary.
[FR Doc. E8-17302 Filed 7-28-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 85, Number 189 (Tuesday, September 29, 2020)]
[Notices]
[Page 60995]
[FR Doc No: 2020-21528]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2016-0654; FRL-10014-49-OMS]

Information Collection Request Submitted to OMB for Review and
Approval; Comment Request; Procedures for Requesting a Chemical Risk
Evaluation Under TSCA

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The Environmental Protection Agency (EPA) has submitted an
information collection request (ICR), Procedures for Requesting a
Chemical Risk Evaluation under TSCA (EPA ICR Number 2559.03, OMB
Control Number 2070-0202) to the Office of Management and Budget (OMB)
for review and approval in accordance with the Paperwork Reduction Act.
This is a proposed extension of the ICR, which is currently approved
through September 30, 2020. Public comments were previously requested
via the Federal Register on January 28, 2020 during a 60-day comment
period. This notice allows for an additional 30 days for public
comments. A fuller description of the ICR is given below, including its
estimated burden and cost to the public. An agency may not conduct or
sponsor and a person is not required to respond to a collection of
information unless it displays a currently valid OMB control number.

DATES: Additional comments may be submitted on or before October 29,
2020.

ADDRESSES: Submit your comments to EPA, referencing Docket ID No. EPA-
HQ-OPPT-2016-0654, online using www.regulations.gov (our preferred
method), or by mail to: EPA Docket Center, Environmental Protection
Agency, Mail Code 28221T, 1200 Pennsylvania Ave. NW, Washington, DC
20460. EPA's policy is that all comments received will be included in
the public docket without change including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be Confidential Business Information (CBI), or other
information whose disclosure is restricted by statute.
    Submit written comments and recommendations to OMB for the proposed
information collection within 30 days of publication of this notice to
www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under 30-day Review--Open for
Public Comments'' or by using the search function.

FOR FURTHER INFORMATION CONTACT: Susanna Blair, Office of Pollution
Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460; telephone number: (202)
564-4371; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Supporting documents, which explain in
detail the information that the EPA will be collecting, are available
in the public docket for this ICR. The docket can be viewed online at
www.regulations.gov or in person at the EPA Docket Center, WJC West,
Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone
number for the Docket Center is<PHONE_NUMBER>. For additional
information about EPA's public docket, visit http://www.epa.gov/dockets.
    Abstract: The information collection activities covered by this ICR
renewal are those carried out by a chemical manufacturer in requesting
a specific chemical risk evaluation under the Toxic Substance Control
Act (TSCA) be conducted by EPA. EPA established the process for
conducting risk evaluations under TSCA. Chemicals that will undergo
this evaluation include chemicals the Agency has prioritized, as well
as chemicals for which EPA has granted requests made by manufacturers
to have the chemicals evaluated under EPA's risk evaluation process.
EPA has established criteria and information chemical manufacturers
must provide for EPA to consider a chemical substance for risk
evaluation. This information is necessary in order for EPA to review
information covered by chemical manufacturers and determine if the
chemical substance is suitable for risk evaluation.
    Form Numbers: None.
    Respondents/affected entities: Persons that manufacture chemical
substances and request a chemical be considered for risk evaluation by
EPA.
    Respondent's obligation to respond: Voluntary (15 U.S.C.
2605(b)(4)).
    Estimated number of respondents: 5.
    Frequency of response: On occasion.
    Total estimated burden: 419 hours (per year). Burden is defined at
5 CFR 1320.03(b).
    Total estimated cost: $283,570 (per year), which includes $0
annualized capital or operation & maintenance costs.
    Changes in the estimates: There is no change in hour or cost burden
as compared with what is currently approved by OMB. There is an
increase of $709 in the total estimated labor costs, which reflects the
increase in wage rates since the initial ICR.

Courtney Kerwin,
Director, Regulatory Support Division.
[FR Doc. 2020-21528 Filed 9-28-20; 8:45 am]
BILLING CODE 6560-50-P