[Federal Register Volume 76, Number 175 (Friday, September 9, 2011)]
[Notices]
[Pages 55893-55894]
[FR Doc No: 2011-23017]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 13583-001]

Crane & Company; Notice of Application Accepted for Filing With
the Commission, Intent To Waive Scoping, Soliciting Motions To
Intervene and Protests, Ready for Environmental Analysis, Soliciting
Comments, Terms and Conditions, Recommendations, and Prescriptions, and
Establishing an Expedited Schedule for Processing

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection.

    a. Type of Application: Exemption from Licensing.
    b. Project No.: 13583-001.
    c. Date filed: March 9, 2011.
    d. Applicant: Crane & Company.
    e. Name of Project: Byron Weston Hydroelectric Project.
    f. Location: On the East Branch of the Housatonic River, in the
Town of Dalton, Berkshire County, Massachusetts. The project would not
occupy lands of the United States.
    g. Filed Pursuant to: Public Utility Regulatory Policies Act of
1978, 16 U.S.C. 2705, 2708.
    h. Applicant Contact: Chad Cox, GZA GeoEnvironmental, Inc., One
Edgewater Drive, Norwood, MA 02062,<PHONE_NUMBER>.
    i. FERC Contact: Brandon Cherry,<PHONE_NUMBER>.
    j. Deadline for filing motions to intervene and protests, comments,
terms and conditions, recommendations, and prescriptions: Due to the
small size and particular location of this project and the close
coordination with state and federal agencies during the preparation of
the application, the 60-day timeframe in 18 CFR 4.34(b) for filing
motions to intervene and protests, comments, terms and conditions,
recommendations, and prescriptions is shortened. Instead, motions to
intervene and protests, comments, terms and conditions,
recommendations, and prescriptions will be due 30 days from the
issuance date of this notice. All reply comments must be filed with the
Commission within 45 days from the date of this notice.
    All documents may be filed electronically via the Internet. See 18
CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web
site http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit
brief comments up to 6,000 characters, without prior registration,
using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact information at the
end of your comments. For assistance, please contact FERC Online
Support at<EMAIL_ADDRESS>or toll free at 1-866-208-3676,
or for TTY,<PHONE_NUMBER>. Although the Commission strongly encourages
electronic filing, documents may also be paper-filed. To paper-file,
mail an original and seven copies to: Kimberly D. Bose, Secretary,
Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426.
    The Commission's Rules of Practice require all intervenors filing
documents with the Commission to serve a copy of that document on each
person on the official service list for the project. Further, if an
intervenor files comments or documents with the Commission relating to
the merits of an issue that may affect the responsibilities of a

particular resource agency, they must also serve a copy of the document
on that resource agency.
    k. This application has been accepted for filing and is now ready
for environmental analysis.
    l. Project Description: The Byron Weston Hydroelectric Project
would consist of: (1) The existing 90-foot-long, 30-foot-high Byron
Weston Dam No. 2; (2) an existing 0.94-acre impoundment with a normal
water surface elevation of 1,116.7 feet NAVD (1988); (3) an existing
intake structure, trashrack, and headgate; (4) an existing 6.5-foot-
long, 6-foot-diameter penstock that conveys flow to an existing 50-
foot-long, 9.5-foot-wide headrace canal connected to a new 15-foot-
long, 4.4-foot-diameter penstock; (5) an existing powerhouse containing
one new 250-kilowatt turbine generating unit; (6) a new steel draft
tube placed within the existing tailrace; and (7) a new 100-foot-long,
600-volt transmission line connected to the Crane & Company mill
complex. The proposed project is estimated to generate an average of
938,000 kilowatt-hours annually.
    m. Due to the project works already existing and the limited scope
of proposed rehabilitation of the project site described above, the
applicant's close coordination with federal and state agencies during
the preparation of the application, completed studies during pre-filing
consultation, and agency-recommended preliminary terms and conditions,
we intend to waive scoping, shorten the notice filing period, and
expedite the exemption process. Based on a review of the application,
resource agency consultation letters including the preliminary 30(c)
terms and conditions, and comments filed to date, Commission staff
intends to prepare a single environmental assessment (EA). Commission
staff determined that the issues that need to be addressed in its EA
have been adequately identified during the pre-filing period, which
included a public meeting and site visit, and no new issues are likely
to be identified through additional scoping. The EA will consider
assessing the potential effects of project construction and operation
on geology and soils, aquatic, threatened and endangered species, land
use, aesthetic, and cultural and historic resources.
    n. A copy of the application is available for review at the
Commission in the Public Reference Room or may be viewed on the
Commission's Web site at http://www.ferc.gov using the ``eLibrary''
link. Enter the docket number excluding the last three digits in the
docket number field to access the document. For assistance, contact
FERC Online Support.
    Register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filings and issuances
related to this or other pending projects. For assistance, contact FERC
Online Support.
    o. Anyone may submit comments, a protest, or a motion to intervene
in accordance with the requirements of Rules of Practice and Procedure,
18 CFR 385.210, .211, and .214. In determining the appropriate action
to take, the Commission will consider all protests or other comments
filed, but only those who file a motion to intervene in accordance with
the Commission's Rules may become a party to the proceeding. Any
comments, protests, or motions to intervene must be received on or
before the specified comment date for the particular application.
    All filings must (1) Bear in all capital letters the title
``Protest'', ``Motion to Intervene'', ``Comments,'' ``Reply Comments,''
``Recommendations,'' ``Terms and Conditions,'' or ``Prescriptions;''
(2) set forth in the heading the name of the applicant and the project
number of the application to which the filing responds; (3) furnish the
name, address, and telephone number of the person protesting or
intervening; and (4) otherwise comply with the requirements of 18 CFR
385.2001 through 385.2005. All comments, recommendations, terms and
conditions or prescriptions must set forth their evidentiary basis and
otherwise comply with the requirements of 18 CFR 4.34(b). Agencies may
obtain copies of the application directly from the applicant. A copy of
any protest or motion to intervene must be served upon each
representative of the applicant specified in the particular
application. A copy of all other filings in reference to this
application must be accompanied by proof of service on all persons
listed in the service list prepared by the Commission in this
proceeding, in accordance with 18 CFR 4.34(b) and 385.2010.
    p. Procedural schedule: The application will be processed according
to the following procedural schedule. Revisions to the schedule may be
made as appropriate.

------------------------------------------------------------------------
                 Milestone                           Target Date
------------------------------------------------------------------------
Notice of the availability of the EA......  February 2012.
------------------------------------------------------------------------

    Dated: September 1, 2011.
Kimberly D. Bose,
 Secretary.
[FR Doc. 2011-23017 Filed 9-8-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 125 (Monday, June 30, 2014)]
[Notices]
[Pages 36860-36861]
[FR Doc No: 2014-15174]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket No. FRA 2014-0011-N-13]

Proposed Agency Information Collection Activities; Comment
Request

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

ACTION: Notice.

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SUMMARY: In accordance with the Paperwork Reduction Act of 1995 and its
implementing regulations, the Federal Railroad Administration (FRA)
hereby announces that it is seeking an extension of the following
currently approved information collection activities. On May 7, 2014,
the Secretary of Transportation issued Emergency Order Docket No. DOT-
OST-2014-0067 (EO), requiring affected railroad carriers to provide
certain information to the State Emergency Response Commissions (SERCs)
for each State in which their trains carrying 1 million gallons or more
of Bakken crude oil travel. The information collection activities
associated with the Secretary's Emergency Order received a six-month
emergency approval from OMB on May 10, 2014. FRA seeks a regular
clearance (extension of the current approval for three years) while it
is determining the proper course of action to take after a recent
series of train accidents involving the transportation petroleum crude
oil, a hazardous material the transportation of which is regulated by
the Department of Transportation. Before submitting these information
collection requirements for clearance by the Office of Management and
Budget (OMB), FRA is soliciting public comment on specific aspects of
the activities identified below.

DATES: Comments must be received no later than August 29, 2014.

ADDRESSES: Submit written comments on any or all of the following
proposed activities by mail to either: Mr. Robert Brogan, Office of
Safety, Planning and Evaluation Division, RRS-21, Federal Railroad
Administration, 1200 New Jersey Ave. SE., Mail Stop 17, Washington, DC
20590, or Ms. Kimberly Toone, Office of Information Technology, RAD-20,
Federal Railroad Administration, 1200 New Jersey Ave. SE., Mail Stop
35, Washington, DC 20590. Commenters requesting FRA to acknowledge
receipt of their respective comments must include a self-addressed
stamped postcard stating, ``Comments on OMB control number 2130-0604.''
Alternatively, comments may be transmitted via facsimile to (202) 493-
6216 or<PHONE_NUMBER>, or via email to Mr. Brogan at
<EMAIL_ADDRESS>or to Ms. Toone at<EMAIL_ADDRESS>Please
refer to the assigned OMB control number in any correspondence
submitted. FRA will summarize comments received in response to this
notice in a subsequent notice and include them in its information
collection submission to OMB for approval.

FOR FURTHER INFORMATION CONTACT: Mr. Robert Brogan, Office of Planning
and Evaluation Division, RRS-21, Federal Railroad Administration, 1200
New Jersey Ave. SE., Mail Stop 17, Washington, DC 20590 (telephone:
(202) 493-6292) or Ms. Kimberly Toone, Office of Information
Technology, RAD-20, Federal Railroad Administration, 1200 New Jersey
Ave. SE., Mail Stop 35, Washington, DC 20590 (telephone: (202) 493-
6132). (These telephone numbers are not toll-free.)

SUPPLEMENTARY INFORMATION: The Paperwork Reduction Act of 1995 (PRA),
Public Law 104-13, sec. 2, 109 Stat. 163 (1995) (codified as revised at
44 U.S.C. 3501-3520), and its implementing regulations, 5 CFR part
1320, require Federal agencies to provide 60-days notice to the public
for comment on information collection activities before seeking
approval for reinstatement or renewal by OMB. 44 U.S.C. 3506(c)(2)(A);
5 CFR 1320.8(d)(1), 1320.10(e)(1), 1320.12(a). Specifically, FRA
invites interested respondents to comment on the following summary of
proposed information collection activities regarding (i) whether the
information collection activities are necessary for FRA to properly
execute its functions, including whether the activities will have
practical utility; (ii) the accuracy of FRA's estimates of the burden
of the information collection activities, including the validity of the
methodology and assumptions used to determine the estimates; (iii) ways
for FRA to enhance the quality, utility, and clarity of the information
being collected; and (iv) ways for FRA to minimize the burden of
information collection activities on the public by automated,
electronic, mechanical, or other technological collection techniques or
other forms of information technology (e.g., permitting electronic
submission of responses). See 44 U.S.C. 3506(c)(2)(A)(I)-(iv); 5 CFR
1320.8(d)(1)(I)-(iv). FRA believes that soliciting public comment will
promote its efforts to reduce the administrative and paperwork burdens
associated with the collection of information mandated

by Federal regulations. In summary, FRA reasons that comments received
will advance three objectives: (i) Reduce reporting burdens; (ii)
ensure that it organizes information collection requirements in a
``user friendly'' format to improve the use of such information; and
(iii) accurately assess the resources expended to retrieve and produce
information requested. See 44 U.S.C. 3501.
    Below are brief summaries of three currently approved information
collection activities that FRA will submit for clearance by OMB as
required under the PRA:
    Title: Secretary of Transportation Emergency Order Docket No. DOT-
OST-2014-0067.
    OMB Control Number: 2130-0604.
    Abstract: As noted in the summary above, on May 7, 2014, the
Secretary of Transportation issued Emergency Order Docket No. DOT-OST-
2014-0067 (EO), requiring affected railroad carriers to provide certain
information to the State Emergency Response Commissions (SERCs) for
each State in which their trains carrying 1 million gallons or more of
Bakken crude oil travel. This EO is available through the Department's
public docket system at www.regulations.gov, under Docket No. DOT-OST-
2014-0067. The EO took effect immediately upon issuance, although
affected railroads were permitted 30 days to provide the required
information to the SERCs. The EO is the Department's direct and
proactive response to a recent series of train accidents involving the
transportation of petroleum crude oil, a hazardous material the
transportation of which is regulated by the Department. The most recent
accident occurred on April 30, 2014, when a train transporting
petroleum crude oil derailed in Lynchburg, Virginia and released
approximately 30,000 gallons of its contents into the James River.
Further, the EO explains that, with the rising demand for rail
transportation of petroleum crude oil throughout the United States, the
risk of rail incidents has increased commensurate with the increase in
the volume of the material shipped and that there have been several
significant derailments in both the U.S. and Canada over the last
several months causing deaths and property and environmental damage
that involved petroleum crude oil. DOT emergency orders are rare and
the EO itself describes the most recent accidents and circumstances
leading the agency to issue the EO. The collection of information
included under this EO is aimed at ensuring that railroads that
transport in a single train a large quantity of petroleum crude oil (1
million gallons or more), particularly crude oil from the Bakken shale
formation in the Williston Basin, provide certain information to the
relevant SERCs in each State in which the railroad operates such
trains. Ensuring that railroads provide this information to SERCs is
critical to ensuring that local and State emergency responders are
aware of the large quantities of crude oil that are being transported
through their jurisdictions and are prepared to respond to accidents
involving such trains should they occur.
    Form Number(s): N/A.
    Affected Public: Businesses.
    Frequency of Submission: One-time; on occasion.
    Respondent Universe: 47 Railroad Carriers; 50 State Emergency
Response Commissions (SERCs).
    Reporting Burden:

----------------------------------------------------------------------------------------------------------------
                                     Respondent
     Emergency order item No.         universe         Total annual         Average time per       Total annual
                                     (railroads)        responses               response           burden hours
----------------------------------------------------------------------------------------------------------------
(1) RR Notification to SERCs.....              47  120 written          30 hours................          3,600.
                                                    notifications.
(2) Updated RR Notification to                 47  25 updated written   4 hours.................            100.
 SERCs.                                             notifications.
(3) Notification Copies to FRA...              47  10 notification      60 minutes..............             10.
                                                    copies.
(4) Requests to RRs by SERCs for               47  30 informational     30 minutes..............             60.
 Information from Local Emergency                   assistance
 Response Agencies Regarding the                    requests + 30
 Volume and Frequency of Train                      informational
 Traffic Implicated by this                         responses.
 Emergency Order within that
 Agency's Jurisdiction and RR
 Responses.
(5) Petitions to the Secretary/                47  4 relief petitions.  2 hours.................              8.
 FRA Administrator for Relief
 from This Emergency Order.
----------------------------------------------------------------------------------------------------------------

    Total Estimated Responses: 219.
    Total Estimated Annual Burden: 3,778 hours.
    Status: Regular Review.
    Pursuant to 44 U.S.C. 3507(a) and 5 CFR 1320.5(b),
1320.8(b)(3)(vi), FRA informs all interested parties that it may not
conduct or sponsor, and a respondent is not required to respond to, a
collection of information unless it displays a currently valid OMB
control number.

    Authority:  44 U.S.C. 3501-3520.

    Issued in Washington, DC, on June 24, 2014.
Erin McCartney,
Acting Chief Financial Officer.
[FR Doc. 2014-15174 Filed 6-27-14; 8:45 am]
BILLING CODE 4910-06-P


[Federal Register Volume 88, Number 228 (Wednesday, November 29, 2023)]
[Notices]
[Pages 83407-83409]
[FR Doc No: 2023-26261]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2022-E-2023, FDA-2022-E-2024, and FDA-2022-E-2025]

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

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 PYLARIFY and is publishing
this notice of that determination as required by law. FDA has made the
determination because of the submission of applications to the Director
of the U.S. Patent and Trademark Office (USPTO), Department of
Commerce, for the extension of patents which claim that human drug
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 January 29, 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 May 28, 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
January 29, 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 Nos.
FDA-2022-E-2023, FDA-2022-E-2024, and FDA-2022-E-2025 for
``Determination of Regulatory Review Period for Purposes of Patent
Extension; PYLARIFY.'' 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, PYLARIFY
(piflufolastat F18). PYLARIFY is indicated for positron emission
tomography of prostate-specific membrane antigen positive lesions in
men with prostate cancer:
     with suspected metastasis who are candidates for initial
definitive therapy.
     with suspected recurrence based on elevated serum
prostate-specific antigen level.
    Subsequent to this approval, the USPTO received patent term
restoration applications for PYLARIFY (U.S. Patent Nos. 8,487,129;
8,778,305; and 9,861,713) from Progenics Pharmaceuticals, Inc., and the
USPTO requested FDA's assistance in determining the patents'
eligibility for patent term restoration. In a letter dated September
13, 2022, FDA advised the USPTO that this human drug product had
undergone a regulatory review period and that the approval of PYLARIFY
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
PYLARIFY is 2,681 days. Of this time,

2,441 days occurred during the testing phase of the regulatory review
period, while 240 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:
January 24, 2014. The applicant claims January 18, 2014, as the date
the investigational new drug application (IND) became effective.
However, FDA records indicate that the IND effective date was January
24, 2014, 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: September 29,
2020. FDA has verified the applicant's claim that the new drug
application (NDA) for PYLARIFY (NDA 214793) was initially submitted on
September 29, 2020.
    3. The date the application was approved: May 26, 2021. FDA has
verified the applicant's claim that NDA 214793 was approved on May 26,
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 applications for patent extension,
this applicant seeks 736 days, 1,373 days or 1,463 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: November 24, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-26261 Filed 11-28-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 86, Number 35 (Wednesday, February 24, 2021)]
[Proposed Rules]
[Pages 11173-11175]
[FR Doc No: 2021-03580]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2021-0031; Project Identifier MCAI-2020-01420-T]
RIN 2120-AA64

Airworthiness Directives; Airbus Canada Limited Partnership (Type
Certificate Previously Held by C Series Aircraft Limited Partnership
(CSALP); Bombardier, Inc.) Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: The FAA proposes to adopt a new airworthiness directive (AD)
for certain Airbus Canada Limited Partnership Model BD-500-1A10 and BD-
500-1A11 airplanes. This proposed AD was prompted by reports of
corrosion on the waste box, waste access doubler, and waste service
door of the rear fuselage due to contamination from waste valve
leakage. This proposed AD would require an inspection for corrosion of
the waste box, waste access doubler, and waste service door, and
corrective actions if necessary, as specified in a Transport Canada
Civil Aviation (TCCA) AD, which is proposed for incorporation by
reference. The FAA is proposing this AD to address the unsafe condition
on these products.

DATES: The FAA must receive comments on this proposed AD by April 12,
2021.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to https://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For material that will be incorporated by reference (IBR) in this
AD, contact TCCA, Transport Canada National Aircraft Certification, 159
Cleopatra Drive, Nepean, Ontario, K1A 0N5, CANADA; telephone 888-663-
3639; email<EMAIL_ADDRESS>internet https://tc.canada.ca/en/aviation.
You may view this IBR material at the FAA, Airworthiness Products
Section, Operational Safety Branch, 2200 South 216th St., Des Moines,
WA. For information on the availability of this material at the FAA,
call<PHONE_NUMBER>. It is also available in the AD docket on the
internet at https://www.regulations.gov by searching for and locating
Docket No. FAA-2021-0031.

Examining the AD Docket

    You may examine the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2021-
0031; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this NPRM, any comments received, and other information. The street
address for Docket Operations is listed above.

FOR FURTHER INFORMATION CONTACT: Siddeeq Bacchus, Aerospace Engineer,
Mechanical Systems and Administrative Services Section, FAA, New York
ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590;
telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under ADDRESSES. Include ``Docket No. FAA-2021-0031; Project Identifier
MCAI-2020-01420-T'' at the beginning of your comments. The most helpful
comments reference a specific portion of the proposal, explain the
reason for any recommended change, and include supporting data. The FAA
will consider all comments received by the closing date and may amend
the proposal because of those comments.
    Except for Confidential Business Information (CBI) as described in
the following paragraph, and other information as described in 14 CFR
11.35, the FAA will post all comments received, without change, to
https://www.regulations.gov, including any personal information you
provide. The agency will also post a report summarizing each
substantive verbal contact received about this proposed AD.

Confidential Business Information

    CBI is commercial or financial information that is both customarily
and actually treated as private by its owner. Under the Freedom of
Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public
disclosure. If your comments responsive to this NPRM contain commercial
or financial information that is customarily treated as private, that
you actually treat as private, and that is relevant or responsive to
this NPRM, it is important that you clearly designate the submitted
comments as CBI. Please mark each page of your submission containing
CBI as ``PROPIN.'' The FAA will treat such marked submissions as
confidential under the FOIA, and they will not be placed in the public
docket of this NPRM. Submissions containing CBI should be sent to
Siddeeq Bacchus, Aerospace Engineer, Mechanical Systems and
Administrative Services Section, FAA, New York ACO Branch, 1600 Stewart
Avenue, Suite 410, Westbury, NY 11590; telephone<PHONE_NUMBER>; fax 516-
794-5531; email<EMAIL_ADDRESS>Any commentary that the FAA
receives which is not specifically designated as CBI will be placed in
the public docket for this rulemaking.

Background

    Transport Canada Civil Aviation (TCCA), which is the aviation
authority for Canada, has issued TCCA AD CF-2020-42, issued October 16,
2020 (TCCA AD CF-2020-42) (also referred to as the Mandatory Continuing
Airworthiness Information, or the MCAI), to correct an unsafe condition
for certain Airbus Canada Limited Partnership Model BD-500-1A10 and BD-
500-1A11 airplanes.
    This proposed AD was prompted by reports of corrosion on the waste
box, waste access doubler, and waste service door 146BR of the rear
fuselage due to contamination from waste valve leakage. Some corrosion
damage has been severe enough to need structural repairs or replacement
of affected parts. The FAA is proposing this AD to address this
corrosion, which could lead to cracking or holes in the waste box or
airplane skin, and consequent cabin pressure leakage and catastrophic
structural damage of the airplane. See the MCAI for additional
background information.

Related Service Information Under 1 CFR Part 51

    TCCA AD CF-2020-42 describes procedures for a general visual
inspection for corrosion of the waste box, waste access doubler, and
waste service door 146BR of the rear fuselage; application of
protective coating in the waste box area; and corrective actions. The
corrective actions include repair of any corrosion found. This material
is reasonably available because the interested parties have access to
it through their normal course of business or by the means identified
in the ADDRESSES section.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to the FAA's bilateral agreement with the State of Design Authority,
the FAA has been notified of the unsafe condition described in the MCAI
referenced above. The FAA is proposing this AD because the FAA
evaluated all the relevant information and determined the unsafe
condition described previously is likely to exist or develop in other
products of the same type design.

Proposed AD Requirements

    This proposed AD would require accomplishing the actions specified
in TCCA AD CF-2020-42, described previously, as incorporated by
reference, except for any differences identified as exceptions in the
regulatory text of this proposed AD.

Explanation of Required Compliance Information

    In the FAA's ongoing efforts to improve the efficiency of the AD
process, the FAA initially worked with Airbus and EASA to develop a
process to use certain EASA ADs as the primary source of information
for compliance with requirements for corresponding FAA ADs. The FAA has
since coordinated with other manufacturers and civil aviation
authorities (CAAs) to use this process. As a result, TCCA AD CF-2020-42
will be incorporated by reference in the FAA final rule. This proposed
AD would, therefore, require compliance with TCCA AD CF-2020-42 in its
entirety, through that incorporation, except for any differences
identified as exceptions in the regulatory text of this proposed AD.
Service information specified in TCCA AD CF-2020-42 that is required
for compliance with TCCA AD CF-2020-42 will be available on the
internet at https://www.regulations.gov by searching for and locating
Docket No. FAA-2021-0031 after the FAA final rule is published.

Costs of Compliance

    The FAA estimates that this proposed AD affects 28 airplanes of
U.S. registry. The FAA estimates the following costs to comply with
this proposed AD:

                                      Estimated Costs for Required Actions
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per       Cost on U.S.
                          Labor cost                              Parts cost        product         operators
----------------------------------------------------------------------------------------------------------------
8 work-hours x $85 per hour = $680...........................              $0             $680          $19,040
----------------------------------------------------------------------------------------------------------------

    The FAA has received no definitive data on which to base the cost
estimates for the on-condition actions specified in this proposed AD.

Authority for This Rulemaking

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

Regulatory Findings

    The FAA determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the

States, on the relationship between the national Government and the
States, or on the distribution of power and responsibilities among the
various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Would not affect intrastate aviation in Alaska, and
    (3) Would not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

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

Airbus Canada Limited Partnership (Type Certificate Previously Held
by C Series Aircraft Limited Partnership (CSALP); Bombardier, Inc.):
Docket No. FAA-2021-0031; Project Identifier MCAI-2020-01420-T.

(a) Comments Due Date

    The FAA must receive comments on this airworthiness directive
(AD) action by April 12, 2021.

(b) Affected Airworthiness Directives (ADs)

    None.

(c) Applicability

    This AD applies to Airbus Canada Limited Partnership (type
certificate previously held by C Series Aircraft Limited Partnership
(CSALP); Bombardier, Inc.) Model BD-500-1A10 and BD-500-1A11
airplanes, certificated in any category, as identified in Transport
Canada Civil Aviation (TCCA) AD CF-2020-42, issued October 16, 2020
(TCCA AD CF-2020-42).

(d) Subject

    Air Transport Association (ATA) of America Code 53, Fuselage.

(e) Reason

    This AD was prompted by reports of corrosion on the waste box,
waste access doubler, and waste service door of the rear fuselage
due to contamination from waste valve leakage. The FAA is issuing
this AD to address this corrosion, which could lead to cracking or
holes in the waste box or airplane skin, and consequent cabin
pressure leakage and catastrophic structural damage of the airplane.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Requirements

    Except as specified in paragraph (h) of this AD: Comply with all
required actions and compliance times specified in, and in
accordance with, TCCA AD CF-2020-42.

(h) Exception to TCCA AD CF-2020-42

    Where TCCA AD CF-2020-42 specifies a compliance time of ``Within
14,200 flight cycles or 56 months from the aeroplane date of
manufacture, as identified on the identification plate of the
aeroplane'' or ``Within 9,900 flight cycles or 56 months from the
aeroplane date of manufacture, as identified on the identification
plate of the aeroplane,'' depending on airplane configuration, to
accomplish corrective actions, this AD requires that corrective
actions be done before further flight after detection of corrosion,
as detected in applicable service information identified in TCCA AD
CF-2020-42.

(i) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager, New
York ACO Branch, FAA, has the authority to approve AMOCs for this
AD, if requested using the procedures found in 14 CFR 39.19. In
accordance with 14 CFR 39.19, send your request to your principal
inspector or local Flight Standards District Office, as appropriate.
If sending information directly to the manager of the certification
office, send it to ATTN: Program Manager, Continuing Operational
Safety, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410,
Westbury, NY 11590; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>. Before
using any approved AMOC, notify your appropriate principal
inspector, or lacking a principal inspector, the manager of the
local flight standards district office/certificate holding district
office.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain instructions from a manufacturer, the instructions must be
accomplished using a method approved by the Manager, New York ACO
Branch, FAA; or Transport Canada Civil Aviation (TCCA); or Airbus
Canada's TCCA Design Approval Organization (DAO). If approved by the
DAO, the approval must include the DAO-authorized signature.

(j) Related Information

    (1) For TCCA AD CF-2020-42, contact TCCA, Transport Canada
National Aircraft Certification, 159 Cleopatra Drive, Nepean,
Ontario, K1A 0N5, CANADA; telephone<PHONE_NUMBER>; email<EMAIL_ADDRESS>internet https://tc.canada.ca/en/aviation. You may view
this material at the FAA, Airworthiness Products Section,
Operational Safety Branch, 2200 South 216th St., Des Moines, WA. For
information on the availability of this material at the FAA, call
206-231-3195. This material may be found in the AD docket on the
internet at https://www.regulations.gov by searching for and
locating Docket No. FAA-2021-0031.
    (2) For more information about this AD, contact Siddeeq Bacchus,
Aerospace Engineer, Mechanical Systems and Administrative Services
Section, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410,
Westbury, NY 11590; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>; email
<EMAIL_ADDRESS>
    Issued on February 4, 2021.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2021-03580 Filed 2-23-21; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 87, Number 191 (Tuesday, October 4, 2022)]
[Notices]
[Pages 60152-60154]
[FR Doc No: 2022-21476]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP22-513-000]

Ohio River System LLC; Notice of Application and Establishing
Intervention Deadline

    Take notice that on August 26, 2022, Ohio River System LLC (ORS),
8111 Westchester Drive, Suite 600, Dallas, Texas 75225, filed a
Notification Regarding Limited Term Certificate in Docket No. CP17-482-
000. The Commission is treating this notification as an application for
ORS to abandon that certificate (Certificate) pursuant to section 7(b)
of the Natural Gas Act (NGA) and part 157 of the Commission's
regulations, and hereby gives notice of this proposed abandonment. ORS'
Certificate granted it authority to provide certain jurisdictional
transportation service in Ohio for a term of four years, which expired
on August 27, 2022. ORS states that its Certificate is no longer
needed, and it does not intend to seek an extension of the Certificate
beyond the initial term. ORS asserts that the sole remaining customer
utilizing the jurisdictional transportation service on the ORS System
has ceased service. No other potential customers have sought such
jurisdictional service and ORS does not anticipate any such customers
in the future. There is no ongoing jurisdictional transportation
service and no customers or shippers will be affected by the
abandonment of the certificate, all as more fully set forth in the
request which is on file with the Commission and open to public
inspection.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://ferc.gov) using the
``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. At this time,
the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance, contact the Federal Energy
Regulatory Commission at [email protected] or call toll-free,
(886) 208-3676 or TYY,<PHONE_NUMBER>.
    Any questions regarding this application should be directed to
Daniel P. Archuleta, Troutman Pepper Hamilton Sanders, LLP, 401 9th
Street NW, Suite 1000, Washington, DC 20004, by telephone at (202) 274-
2926 or by email at [email protected].
    Pursuant to section 157.9 of the Commission's Rules of Practice and
Procedure,\1\ within 90 days of this Notice the Commission staff will
either: complete its environmental review and place it into the
Commission's public record (eLibrary) for this proceeding; or issue a
Notice of Schedule for Environmental Review. If a Notice of Schedule
for Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission staff's issuance of
the final environmental impact statement (FEIS) or environmental
assessment (EA) for this proposal. The filing of an EA in the
Commission's public record for this proceeding or the issuance of a
Notice of Schedule for Environmental Review will serve to notify
federal and state agencies of the timing for the completion of all
necessary reviews, and the subsequent need to complete all federal
authorizations within 90 days of the date of issuance of the Commission
staff's FEIS or EA.
---------------------------------------------------------------------------

    \1\ 18 CFR (Code of Federal Regulations) 157.9.
---------------------------------------------------------------------------

Public Participation

    There are two ways to become involved in the Commission's review of
this project: you can file comments on the project, and you can file a
motion to intervene in the proceeding. There is no fee or cost for
filing comments or

intervening. The deadline for filing a motion to intervene is 5 p.m.
eastern time on October 19, 2022.

Comments

    Any person wishing to comment on the project may do so. Comments
may include statements of support or objections to the project as a
whole or specific aspects of the project. The more specific your
comments, the more useful they will be. To ensure that your comments
are timely and properly recorded, please submit your comments on or
before October 19, 2022.
    There are three methods you can use to submit your comments to the
Commission. In all instances, please reference the Project docket
number CP22-513-000 in your submission.
    (1) You may file your comments electronically by using the eComment
feature, which is located on the Commission's website at www.ferc.gov
under the link to Documents and Filings. Using eComment is an easy
method for interested persons to submit brief, 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 website (www.ferc.gov)
under the link to Documents and Filings. With eFiling, you can provide
comments in a variety of formats by attaching them as a file with your
submission. New eFiling users must first create an account by clicking
on ``eRegister.'' You will be asked to select the type of filing you
are making; first select ``General'' and then select ``Comment on a
Filing''; or
    (3) You may file a paper copy of your comments by mailing them to
the following address below.\2\ Your written comments must reference
the Project docket number (CP22-513-000).
---------------------------------------------------------------------------

    \2\ Hand delivered submissions in docketed proceedings should be
delivered to Health and Human Services, 12225 Wilkins Avenue,
Rockville, Maryland 20852.
---------------------------------------------------------------------------

    Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission,
888 First Street NE, Washington, DC 20426.
    The Commission encourages electronic filing of comments (options 1
and 2 above) and has eFiling staff available to assist you at (202)
502-8258 or [email protected]
    Persons who comment on the environmental review of this project
will be placed on the Commission's environmental mailing list and will
receive notification when the environmental documents (EA or EIS) are
issued for this project and will be notified of meetings associated
with the Commission's environmental review process.
    The Commission considers all comments received about the project in
determining the appropriate action to be taken. However, the filing of
a comment alone will not serve to make the filer a party to the
proceeding. To become a party, you must intervene in the proceeding.
For instructions on how to intervene, see below.

Interventions

    Any person, which includes individuals, organizations, businesses,
municipalities, and other entities,\3\ has the option to file a motion
to intervene in this proceeding. Only intervenors have the right to
request rehearing of Commission orders issued in this proceeding and to
subsequently challenge the Commission's orders in the U.S. Circuit
Courts of Appeal.
---------------------------------------------------------------------------

    \3\ 18 CFR 385.102(d).
---------------------------------------------------------------------------

    To intervene, you must submit a motion to intervene to the
Commission in accordance with Rule 214 of the Commission's Rules of
Practice and Procedure \4\ and the regulations under the NGA \5\ by the
intervention deadline for the project, which is October 19, 2022. As
described further in Rule 214, your motion to intervene must state, to
the extent known, your position regarding the proceeding, as well as
your interest in the proceeding. For an individual, this could include
your status as a landowner, ratepayer, resident of an impacted
community, or recreationist. You do not need to have property directly
impacted by the project in order to intervene. For more information
about motions to intervene, refer to the FERC website at https://www.ferc.gov/resources/guides/how-to/intervene.asp.
---------------------------------------------------------------------------

    \4\ 18 CFR 385.214.
    \5\ 18 CFR 157.10.
---------------------------------------------------------------------------

    There are two ways to submit your motion to intervene. In both
instances, please reference the Project docket number CP22-513-000 in
your submission.
    (1) You may file your motion to intervene by using the Commission's
eFiling feature, which is located on the Commission's website
(www.ferc.gov) under the link to Documents and Filings. New eFiling
users must first create an account by clicking on ``eRegister.'' You
will be asked to select the type of filing you are making; first select
``General'' and then select ``Intervention.'' The eFiling feature
includes a document-less intervention option; for more information,
visit https://www.ferc.gov/docs-filing/efiling/document-less-intervention.pdf.; or
    (2) You can file a paper copy of your motion to intervene, along
with three copies, by mailing the documents to the address below.\6\
Your motion to intervene must reference the Project docket number CP22-
513-000.
---------------------------------------------------------------------------

    \6\ Hand delivered submissions in docketed proceedings should be
delivered to Health and Human Services, 12225 Wilkins Avenue,
Rockville, Maryland 20852.
---------------------------------------------------------------------------

    Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission,
888 First Street NE, Washington, DC 20426.
    The Commission encourages electronic filing of motions to intervene
(option 1 above) and has eFiling staff available to assist you at (202)
502-8258 or [email protected]
    Protests and motions to intervene must be served on the applicant
either by mail or email at: Daniel P. Archuleta, Troutman Pepper
Hamilton Sanders, LLP, 401 9th Street NW, Suite 1000, Washington, DC
20004, by telephone at<PHONE_NUMBER> or by email at
[email protected]. Any subsequent submissions by an
intervenor must be served on the applicant and all other parties to the
proceeding. Contact information for parties can be downloaded from the
service list at the eService link on FERC Online. Service can be via
email with a link to the document.
    All timely, unopposed \7\ motions to intervene are automatically
granted by operation of Rule 214(c)(1).\8\ Motions to intervene that
are filed after the intervention deadline are untimely, and may be
denied. Any late-filed motion to intervene must show good cause for
being late and must explain why the time limitation should be waived
and provide justification by reference to factors set forth in Rule
214(d) of the Commission's Rules and Regulations.\9\ A person obtaining
party status will be placed on the service list maintained by the
Secretary of the Commission and will receive copies (paper or
electronic) of all documents filed by the applicant and by all other
parties.
---------------------------------------------------------------------------

    \7\ The applicant has 15 days from the submittal of a motion to
intervene to file a written objection to the intervention.
    \8\ 18 CFR 385.214(c)(1).
    \9\ 18 CFR 385.214(b)(3) and (d).
---------------------------------------------------------------------------

Tracking the Proceeding

    Throughout the proceeding, additional information about the
projects will be available from the Commission's Office of External
Affairs, at (866) 208-FERC, or on the FERC website at www.ferc.gov
using the ``eLibrary'' link as described above. The eLibrary link also
provides access to the texts of all formal documents issued by the
Commission, such as orders, notices, and rulemakings.

    In addition, the Commission offers a free service called
eSubscription which 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. For more information and to register, go to
www.ferc.gov/docs-filing/esubscription.asp.
    Intervention Deadline: 5 p.m. eastern time on October 19, 2022.

    Dated: September 28, 2022.
Kimberly D. Bose,
Secretary.
[FR Doc. 2022-21476 Filed 10-3-22; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 78, Number 2 (Thursday, January 3, 2013)]
[Notices]
[Pages 330-332]
[FR Doc No: 2012-31568]

=======================================================================
-----------------------------------------------------------------------

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-68540; File No. SR-ICEEU-2012-18]

 Self-Regulatory Organizations; ICE Clear Europe Limited; Notice
of Filing and Immediate Effectiveness of Proposed Rule Change To Amend
SPAN Margin Parameters for ICE OTC Natural Gas Liquids Contracts

December 27, 2012.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on December 19, 2012, ICE Clear Europe Limited (``ICE Clear Europe'')
filed with the Securities and Exchange Commission (``Commission'') the
proposed rule change as described in Items I, II and III below, which
Items have been prepared

primarily by ICE Clear Europe. ICE Clear Europe filed the proposal
pursuant to Section 19(b)(3)(A)(iii) of the Act,\3\ and Rule 19b-
4(f)(4)(ii) thereunder,\4\ so that the proposal was effective upon
filing with the Commission. The Commission is publishing this notice to
solicit comments on the proposed change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \4\ 17 CFR 240.19b-4(f)(4)(ii).
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The purpose of the change is to amend SPAN Margin Parameters for
ICE OTC Natural Gas Liquids (NGL) Contracts. All capitalized terms not
defined herein are defined in the ICE Clear Europe Rules.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, ICE Clear Europe included
statements concerning the purpose of and basis for the proposed rule
change and discussed any comments it received on the proposed rule
change. The text of these statements may be examined at the places
specified in Item IV below. ICE Clear Europe has prepared summaries,
set forth in sections A, B, and C below, of the most significant
aspects of these statements.\5\
---------------------------------------------------------------------------

    \5\ The Commission has modified the text of the summaries
prepared by ICE Clear Europe.
---------------------------------------------------------------------------

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In addition to providing clearing services for credit default
swaps, ICE Clear Europe also provides clearing services for non-
securities contracts in energy and emissions markets (``Energy Futures
Products''). SPAN[supreg] \6\ is a risk evaluation and margin framework
algorithm employed to calculate Original Margin for certain Energy
Futures Products. As of September 20, 2011, ICE Clear Europe changed
the SPAN margin parameters for ICE OTC NGL Contracts. All updated
SPAN[supreg] margin parameters can be found at: https://www.theice.com/clear_europe_span_parameters.jhtml.
---------------------------------------------------------------------------

    \6\ SPAN is a registered trademark of Chicago Mercantile
Exchange Inc., used herein under license. Chicago Mercantile
Exchange Inc. assumes no responsibility in connection with the use
of SPAN by any person or entity.
---------------------------------------------------------------------------

    Section 17A(b)(3)(F) of the Act \7\ requires, among other things,
that the rules of a clearing agency be designed to promote the prompt
and accurate clearance and settlement of securities transactions and,
to the extent applicable, derivative agreements, contracts, and
transactions. ICE Clear Europe believes that the proposed change with
respect to Energy Futures Products is consistent with the requirements
of the Act and the rules and regulations thereunder applicable to ICE
Clear Europe, in particular, with Section 17A(b)(3)(F),\8\ because
improved margining of NGL contracts protects investors and the public
interest.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78q-1(b)(3)(F).
    \8\ 15 U.S.C. 78q-1(b)(3)(F).
---------------------------------------------------------------------------

B. Self-Regulatory Organization's Statement on Burden on Competition

    ICE Clear Europe does not believe the proposed change would have
any impact, or impose any burden, on competition.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants or Others

    Written comments relating to the proposed change have not been
solicited or received. ICE Clear Europe will notify the Commission of
any written comments received by ICE Clear Europe.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    The foregoing rule change has become effective upon filing pursuant
to Section 19(b)(3)(A)(iii) of the Act \9\ and Rule 19b-4(f)(4)(ii)
\10\ thereunder because it primarily affects the futures clearing
operations of the clearing agency with respect to futures that are not
security futures, and does not significantly affect any securities
clearing operations of the clearing agency or any related rights or
obligations of the clearing agency or persons using such service. At
any time within 60 days of the filing of the proposed rule change, the
Commission summarily may temporarily suspend such rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors, or otherwise
in furtherance of the purposes of the Act.\11\
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \10\ 17 CFR 240.19b-4(f)(4)(ii).
    \11\ 15 U.S.C. 78s(b)(3)(C).
---------------------------------------------------------------------------

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml) or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-ICEEU-2012-18 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-ICEEU-2012-18. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of such filings will also be available
for inspection and copying at the principal office of ICE Clear Europe
and on ICE Clear Europe's Web site at https://www.theice.com/publicdocs/regulatory_filings/ICEU_SEC_121912_2012-18.pdf.
    All comments received will be posted without change; the Commission
does not edit personal identifying information from submissions. You
should submit only information that you wish to make available
publicly. All submissions should refer to File Number SR-ICEEU-2012-18
and should be submitted on or before January 24, 2013.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\12\
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    \12\ 17 CFR 200.30-3(a)(12).
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Elizabeth M. Murphy,
Secretary.
[FR Doc. 2012-31568 Filed 1-2-13; 8:45 am]
BILLING CODE 8011-01-P