[Federal Register Volume 84, Number 250 (Tuesday, December 31, 2019)]
[Notices]
[Pages 72349-72350]
[FR Doc No: 2019-28253]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER10-2124-021.
    Applicants: Spring Canyon Energy LLC.
    Description: Triennial Report of Spring Canyon Energy LLC.
    Filed Date: 12/20/19.
    Accession Number: 20191220-5364.
    Comments Due: 5 p.m. ET 2/18/20.

    Docket Numbers: ER10-2125-022.
    Applicants: Judith Gap Energy LLC.
    Description: Triennial Report of Judith Gap Energy LLC.
    Filed Date: 12/20/19.
    Accession Number: 20191220-5372.
    Comments Due: 5 p.m. ET 2/18/20.

    Docket Numbers: ER10-2128-021.
    Applicants: Wolverine Creek Energy LLC.
    Description: Triennial Report of Wolverine Creek Energy LLC.
    Filed Date: 12/20/19.
    Accession Number: 20191220-5358.
    Comments Due: 5 p.m. ET 2/18/20.

    Docket Numbers: ER10-2132-021.
    Applicants: Willow Creek Energy LLC.
    Description: Triennial Report of Willow Creek Energy LLC.
    Filed Date: 12/20/19.
    Accession Number: 20191220-5359.
    Comments Due: 5 p.m. ET 2/18/20.

    Docket Numbers: ER10-2764-021.
    Applicants: Vantage Wind Energy LLC.
    Description: Triennial Report of Vantage Wind Energy LLC.
    Filed Date: 12/20/19.
    Accession Number: 20191220-5363.
    Comments Due: 5 p.m. ET 2/18/20.

    Docket Numbers: ER10-2861-007; ER13-1504-008; ER10-2866-007.
    Applicants: Fountain Valley Power, L.L.C., SWG Arapahoe, LLC, SWG
Colorado, LLC.
    Description: Updated Market Power Analysis for the Northwest Region
of Fountain Valley Power, L.L.C., et al.
    Filed Date: 12/20/19.
    Accession Number: 20191220-5380.
    Comments Due: 5 p.m. ET 2/18/20.

    Docket Numbers: ER16-1720-010.
    Applicants: Invenergy Energy Management LLC.
    Description: Triennial Report of Invenergy Energy Management LLC.
    Filed Date: 12/20/19.
    Accession Number: 20191220-5374.
    Comments Due: 5 p.m. ET 2/18/20.

    Docket Numbers: ER20-442-000.
    Applicants: Wildcat I Energy Storage, LLC.
    Description: Supplement to November 22, 2019 Wildcat I Energy
Storage, LLC tariff filing.
    Filed Date: 12/20/19.
    Accession Number: 20191220-5371.
    Comments Due: 5 p.m. ET 1/10/20.

    Docket Numbers: ER20-443-000.
    Applicants: Acorn I Energy Storage, LLC.
    Description: Supplement to November 22, 2019 Acorn I Energy
Storage, LLC tariff filing.
    Filed Date: 12/20/19.
    Accession Number: 20191220-5370.
    Comments Due: 5 p.m. ET 1/10/20.

    Docket Numbers: ER20-650-001.
    Applicants: El Paso Electric Company.
    Description: Tariff Amendment: Service Agreement No. 325, Large
Generator Interconnection Agreement with EDF to be effective 12/9/2019.
    Filed Date: 12/23/19.
    Accession Number: 20191223-5002.
    Comments Due: 5 p.m. ET 1/13/20.

    Docket Numbers: ER20-670-000.
    Applicants: Consolidated Edison Company of New York, Inc.
    Description: Sec.  205(d) Rate Filing: DCFC Filing 12-2019 to be
effective 12/23/2019.
    Filed Date: 12/23/19.
    Accession Number: 20191223-5003.
    Comments Due: 5 p.m. ET 1/13/20.

    Docket Numbers: ER20-671-000.
    Applicants: Niagara Mohawk Power Corporation, New York Independent
System Operator, Inc.
    Description: Sec.  205(d) Rate Filing: 205 filing re: LGIA (SA
2500) between Niagara Mohawk and Covanta Niagara I to be effective 11/
26/2019.
    Filed Date: 12/23/19.
    Accession Number: 20191223-5005.
    Comments Due: 5 p.m. ET 1/13/20.

    Take notice that the Commission received the following electric
reliability filings:

    Docket Numbers: RR20-2-000.
    Applicants: North American Electric Reliability Corporation, SERC
Reliability Corporation.
    Description: Joint Petition of the North American Electric
Reliability Corporation and SERC Reliability Corporation for Approval
of Amendments to SERC Reliability Corporation's Bylaws.
    Filed Date: 12/20/19.
    Accession Number: 20191220-5351.
    Comments Due: 5 p.m. ET 1/10/20.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing

requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: December 23, 2019.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2019-28253 Filed 12-30-19; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 141 (Thursday, July 23, 2015)]
[Rules and Regulations]
[Page 43625]
[FR Doc No: 2015-18074]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2015-0502]
RIN 1625-AA00

Safety Zones; Annual Events in the Captain of the Port Buffalo
Zone

AGENCY: Coast Guard, DHS.

ACTION: Notice of enforcement of regulation.

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SUMMARY: At various times throughout the month of August, the Coast
Guard will enforce certain safety zones located in the Captain of the
Port Buffalo Zone. This action is necessary and intended for the safety
of life and property on navigable waters during this event. During each
enforcement period, no person or vessel may enter the respective safety
zone without the permission of the Captain of the Port Buffalo.

DATES: The regulations in 33 CFR 165.939(a)(30) will be enforced on
August 15 and 16, 2015 from 9 a.m. to 5 p.m.

FOR FURTHER INFORMATION CONTACT: If you have questions on this notice
of enforcement, call or email Petty Officer Willie Diaz, Waterways
Management Division, Coast Guard Sector Buffalo, 1 Fuhrmann Blvd.,
Buffalo, NY 14203; Coast Guard telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Coast Guard will enforce the Safety
Zones; Annual Events in the Captain of the Port Buffalo Zone listed in
33 CFR 165.939(a)(30) for the following events:
    (1) Thunder on the Niagara Hydroplane Boat Races, North Tonawanda,
NY; The safety zone listed in 33 CFR 165.939(a)(30) will be enforced
from 9 a.m. to 5 p.m. on August 15, 2015 and August 16, 2015.
    Pursuant to 33 CFR 165.23, entry into, transiting, or anchoring
within these safety zones during an enforcement period is prohibited
unless authorized by the Captain of the Port Buffalo or his designated
representative. Those seeking permission to enter one of these safety
zones may request permission from the Captain of Port Buffalo via
channel 16, VHF-FM. Vessels and persons granted permission to enter one
of these safety zones shall obey the directions of the Captain of the
Port Buffalo or his designated representative. While within a safety
zone, all vessels shall operate at the minimum speed necessary to
maintain a safe course.
    This notice of enforcement is issued under authority of 33 CFR
165.939 and 5 U.S.C. 552(a). In addition to this notice in the Federal
Register, the Coast Guard will provide the maritime community with
advance notification of these enforcement periods via Broadcast Notice
to Mariners or Local Notice to Mariners. If the Captain of the Port
Buffalo determines that one of these safety zones need not be enforced
for the full duration stated in this notice of enforcement he or she
may use a Broadcast Notice to Mariners to grant general permission to
enter the respective safety zone.

    Dated: June 15, 2015.
B.W. Roche,
Captain, U.S. Coast Guard, Captain of the Port Buffalo.
[FR Doc. 2015-18074 Filed 7-22-15; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 82, Number 221 (Friday, November 17, 2017)]
[Notices]
[Pages 54357-54359]
[FR Doc No: 2017-24926]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0313]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Guidance for Industry, Researchers, Patient Groups,
and Food and Drug Administration Staff on Meetings With the Office of
Orphan Products Development

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on the Guidance for Industry, Researchers,
Patient Groups, and FDA Staff on Meetings with the Office of Orphan
Products Development.

DATES: Submit either electronic or written comments on the collection
of information by January 16, 2018.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before January 16, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of January 16, 2018. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is 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-2014-D-0313 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Guidance for Industry,
Researchers, Patient Groups, and Food and Drug Administration Staff on
Meetings with the Office of Orphan Products Development.'' 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.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information

redacted/blacked out, will be available for public viewing and posted
on https://www.regulations.gov. Submit both copies to the Dockets
Management Staff. If you do not wish your name and contact information
to be made publicly available, you can provide this information on the
cover sheet and not in the body of your comments and you must identify
this information as ``confidential.'' Any information marked as
``confidential'' will not be disclosed except in accordance with 21 CFR
10.20 and other applicable disclosure law. For more information about
FDA's posting of comments to public dockets, see 80 FR 56469, September
18, 2015, or access the information at: https://www.gpo.gov/fdsys/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.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Guidance for Industry, Researchers, Patient Groups, and Food and Drug
Administration Staff on Meetings With the Office of Orphan Products
Development

OMB Control Number 0910-0787--Extension

    This information collection supports Agency guidance regarding
staff meetings with the Office of Orphan Products Development. Each
year, the Office of Orphan Products Development (OOPD) staff
participates in meetings with stakeholders who seek guidance or
clarification relating to orphan drug or humanitarian use device (HUD)
designation requests, OOPD grant programs, or other rare disease
issues. These meetings can be ``informal'' or ``formal'' and help build
a common understanding on FDA's thoughts on orphan products, which may
include drugs, biological products, devices, or medical foods for a
rare disease or condition. These meetings may represent critical points
in the orphan product development process and may even have an impact
on the eventual availability of products for patients with rare
diseases and conditions. It is important that these meetings be
scheduled within a reasonable time, conducted effectively, and
documented where appropriate.
    Topics addressed in this guidance include: (1) Clarification of
what constitutes an ``informal'' or ``formal'' meeting, (2) program
areas within OOPD that may be affected by this draft guidance, (3)
procedures for requesting and scheduling meetings with OOPD, (4)
description of what constitutes a meeting package, and (5) procedures
for the conduct and documentation of meetings with OOPD. This guidance
provides consistent procedures to promote well-managed meetings between
OOPD and stakeholders.
    Burden estimate. Table 1 of this document provides an estimate of
the annual reporting burden associated with the recommendation found in
the guidance.
    Request for a meeting. Based upon information collected from OOPD
program areas, approximately 2,332 informal and 51 formal meetings were
requested with OOPD in fiscal year (FY) 2016 regarding orphan drug
designation requests, HUD designation requests, rare pediatric disease
designation requests, funding opportunities through the Orphan Products
Grants Program and the Pediatric Device Consortia Grants Program, and
orphan product patient-related issues. FDA anticipates that the number
of meeting requests and stakeholders will remain the same or will only
slightly increase and therefore estimates the total number of meeting
requests will be 2,383 annually (2332 informal and 51 formal meetings).
The hours per response, which is the estimated number of hours that a
stakeholder would spend preparing the information to be submitted with
a meeting request in accordance with the guidance, is estimated to be
approximately 3 hours for informal meetings and approximately 10 hours
for formal meetings. Based on FDA's experience, the Agency expects that
it will take stakeholders this amount of time to gather and copy brief
statements about the product and a description of the purpose and
details of the meeting. Therefore, the Agency estimates that
stakeholders will spend 7,506 hours per year (6,996 hours for informal
meetings and 510 hours for formal meetings) preparing meeting requests
to OOPD regarding orphan drug designation requests, HUD designation
requests, rare pediatric disease designation requests, funding
opportunities through the Orphan Products Grants Program and the
Pediatric Device Consortia Grants Program, and orphan product patient-
related issues.
    Meeting packages. Based upon information collected from OOPD
program areas, OOPD held approximately 51 formal meetings in FY 2016
regarding orphan drug designation requests, HUD designation requests,
rare pediatric disease designation requests, funding opportunities
through the Orphan Products Grants Program and the Pediatric Device
Consortia Grants Program, and orphan product patient-related issues.
FDA anticipates that the number of formal meetings, and therefore
meeting packages, may increase only slightly as a result of this
guidance; thus, the Agency estimates that the total responses will be
51 annually. As stated previously, it is current practice for
stakeholders to submit meeting packages to the Agency in advance of any
such formal meeting. The hours per response, which is the

estimated number of hours that a stakeholder would spend preparing the
meeting package in accordance with this guidance, is estimated to be
approximately 18 hours. Based on FDA's experience, the Agency expects
it will take stakeholders this amount of time to gather and copy brief
statements about the product, a description of details for the
anticipated meeting, and data and information that generally would
already have been compiled for submission to the Agency. Therefore, the
Agency estimates that stakeholders will spend 918 hours per year
submitting meeting packages to the Agency prior to a formal meeting
regarding orphan drug designation requests, HUD designation requests,
rare pediatric disease designation requests, funding opportunities
through the Orphan Products Grants Program and the Pediatric Device
Consortia Grants Program, and orphan product patient-related issues.
    Draft meeting minutes. Based upon information collected from OOPD
program areas, OOPD received approximately 51 draft meeting minutes for
formal meetings and 23 draft meeting minutes for informal meetings in
FY 2016 regarding orphan drug designation requests, HUD designation
requests, rare pediatric disease designation requests, funding
opportunities through the Orphan Products Grants Program and the
Pediatric Device Consortia Grants Program, and orphan product patient-
related issues. FDA anticipates that the number of stakeholders
submitting draft meeting minutes may remain the same or increase only
slightly; thus, the Agency estimates that the total number of
respondents will be 74 annually. As stated previously, it is current
practice for stakeholders to submit draft meeting minutes to the Agency
after all formal meetings and certain informal meetings. The hours per
response, which is the estimated number of hours that a stakeholder
would spend preparing draft meeting minutes in accordance with this
guidance, is estimated to be approximately 8 hours. Based on FDA's
experience, the Agency expects it will take stakeholders this amount of
time to summarize the meeting discussion points, agreements,
disagreements, and action items. Therefore, the Agency estimates that
stakeholders will spend 592 hours per year submitting draft meeting
minutes to the Agency documenting the meeting outcomes, agreements,
disagreements, and action items as followup to all formal and certain
informal meetings.
    FDA therefore estimates the burden of this collection of
information as follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
 Meeting requests, packages and      Number of     responses per   Total annual     burden per      Total hours
             minutes                respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
Meeting requests (informal).....           2,332               1           2,332               3           6,996
Meeting requests (formal).......              51               1              51              10             510
Meeting packages................              51               1              51              18             918
Meeting minutes.................              74               1              74               8             592
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           9,016
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Since the last OMB approval, we have increased our estimate by 832
hours and 229 respondents in parallel to an increase in overall orphan
drug designation submissions and to correspond meeting requests to the
Office of Orphan Products Development.

    Dated: November 9, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-24926 Filed 11-16-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: November 24, 2009 (Volume 74, Number 225)]
[Notices]
[Page 61341-61342]
[DOCID:fr24no09-42]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings No. 2

November 16, 2009.
    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

    Docket Numbers: RP10-40-001.
    Applicants: Southern Natural Gas Company.
    Description: Southern Natural Gas Company submits Fourth Revised
Sheet 231 to its FERC Gas Tariff, Seventh Revised Volume 1 under RP10-
40.
    Filed Date: 11/10/2009.
    Accession Number: 20091113-0142.
    Comment Date: 5 p.m. Eastern Time on Monday, November 23, 2009.

    Docket Numbers: RP10-111-001.
    Applicants: Equitrans, L.P.
    Description: Equitrans, LP submits Substitute Seventh Revised
Tariff Sheet 317 et al. to FERC Gas Tariff, Original Volume 1.
    Filed Date: 11/12/2009.
    Accession Number: 20091113-0103.
    Comment Date: 5 p.m. Eastern Time on Tuesday, November 24, 2009.

    Docket Numbers: RP10-96-001.
    Applicants: Equitrans, L.P.
    Description: Equitrans, LP submits Substitute Sixth Revised Tariff
Sheet 317 et al. to FERC Gas Tariff, Original Volume 1, to be effective
11/1/09.
    Filed Date: 11/12/2009.
    Accession Number: 20091113-0104.
    Comment Date: 5 p.m. Eastern Time on Tuesday, November 24, 2009.

    Any person desiring to protest this filing must file in accordance
with Rule 211 of the Commission's Rules of Practice and Procedure (18
CFR 385.211). Protests to this filing will be considered by the
Commission in determining the appropriate action to be taken, but will
not serve to make protestants parties to the proceeding. Such protests
must be filed in accordance with the provisions of Section 154.210 of
the Commission's regulations (18 CFR 154.210). Anyone filing a protest
must serve a copy of that document on all the parties to the
proceeding.
    The Commission encourages electronic submission of protests in lieu
of paper using the ``eFiling'' link at http://www.ferc.gov. Persons
unable to file electronically should submit an original and 14 copies
of the protest to the Federal Energy Regulatory Commission, 888 First
Street, NE., Washington, DC 20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.

Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. E9-28107 Filed 11-23-09; 8:45 am]

BILLING CODE 6717-01-P