[Federal Register Volume 86, Number 127 (Wednesday, July 7, 2021)]
[Notices]
[Pages 35785-35786]
[FR Doc No: 2021-14469]

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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: ER10-1186-012; ER10-1329-012; ER11-2731-005; ER11-
3097-013.
    Applicants: DTE Energy Supply, Inc., DTE Electric Company, DTE
Energy Trading, Inc., DTE Garden Wind Farm, LLC, DTE Stoney Corners
Wind Farm, LLC, St. Paul Cogeneration, LLC.
    Description: Triennial Market Power Analysis for Central Region of
DTE Energy Supply, Inc., et al.
    Filed Date: 6/29/21.
    Accession Number: 20210629-5267.
    Comments Due: 5 p.m. ET 8/30/21.

    Docket Numbers: ER10-1520-006; ER10-1521-006; ER10-1522-005; ER20-
2493-001.
    Applicants: Occidental Power Services, Inc., Occidental Power
Marketing, L.P., Occidental Chemical Corporation, OTCF, LLC.
    Description: Triennial Market Power Analysis for Central Region of
Occidental Power Services, Inc., et al.
    Filed Date: 6/29/21.
    Accession Number: 20210629-5214.
    Comments Due: 5 p.m. ET 8/30/21.

    Docket Numbers: ER10-1581-025; ER10-2265-019; ER11-1846-010; ER11-
1847-010; ER11-1850-010; ER11-2062-027; ER11-2175-005; ER11-2176-004;
ER11-2598-013; ER11-3188-005; ER11-3418-007; ER11-4307-028; ER11-4308-
028; ER12-224-006; ER12-225-006; ER12-2301-005; ER12-261-027; ER13-
1192-007; ER17-764-005; ER17-765-005; ER17-767-005; ER18-1160-003.
    Applicants: NRG Power Marketing LLC, Direct Energy Business, LLC,
Direct Energy Business Marketing, LLC, Direct Energy Marketing Inc.,
Direct Energy Services, LLC, Energy Plus Holdings LLC, Gateway Energy
Services Corporation, Green Mountain Energy Company, Independence
Energy Group LLC, Long Beach Peakers LLC, NRG Cottonwood Tenant LLC,
Reliant Energy Northeast LLC, SGE Energy Sourcing, LLC, Stream Energy
Columbia, LLC, Stream Energy Delaware, LLC, Stream Energy Illinois,
LLC, Stream Energy Maryland, LLC, Stream Energy New Jersey, LLC, Stream
Energy New York, LLC, Stream Energy Pennsylvania, LLC, Stream Ohio Gas
& Electric, LLC, XOOM Energy, LLC.
    Description: Triennial Market Power Analysis for Central Region of
Long Beach Peakers LLC, et al.
    Filed Date: 6/29/21.
    Accession Number: 20210629-5266.
    Comments Due: 5 p.m. ET 8/30/21.

    Docket Numbers: ER10-1874-013; ER19-9-007.
    Applicants: Mankato Energy Center, LLC, Mankato Energy Center II,
LLC.
    Description: Triennial Market Power Analysis for Central Region of
Mankato Energy Center, LLC, et al.
    Filed Date: 6/29/21.
    Accession Number: 20210629-5264.
    Comments Due: 5 p.m. ET 8/30/21.

    Docket Numbers: ER10-2742-016; ER14-153-010; ER14-154-010; ER16-
517-005.
    Applicants: Tilton Energy LLC, Gibson City Energy Center, LLC,
Grand Tower Energy Center, LLC, Shelby County Energy Center, LLC,
Southern Illinois Generation Company, LLC.

    Description: Triennial Market Power Analysis for Central Region of
Tilton Energy, LLC, et al.
    Filed Date: 6/29/21.
    Accession Number: 20210629-5265.
    Comments Due: 5 p.m. ET 8/30/21.

    Docket Numbers: ER17-1442-003.
    Applicants: Axiall, LLC.
    Description: Triennial Market Power Analysis for Central Region of
Axiall, LLC.
    Filed Date: 6/29/21.
    Accession Number: 20210629-5215.
    Comments Due: 5 p.m. ET 8/30/21.

    Docket Numbers: ER21-1264-002.
    Applicants: Duke Energy Indiana, LLC.
    Description: Tariff Amendment: Amendment to Annual Reconciliation
Filing to be effective 7/1/2020.
    Filed Date: 6/29/21.
    Accession Number: 20210629-5167.
    Comments Due: 5 p.m. ET 7/20/21.

    Docket Numbers: ER21-1848-000.
    Applicants: Isabella Wind, LLC.
    Description: Report Filing: Isabella Wind Supplemental MBR
Cancellation Filing to be effective N/A.
    Filed Date: 6/30/21.
    Accession Number: 20210630-5000.
    Comments Due: 5 p.m. ET 7/21/21.

    Docket Numbers: ER21-2264-000.
    Applicants: Terra-Gen Energy Services, LLC.
    Description: Tariff Cancellation: Notice of Cancellation to be
effective 6/30/2021.
    Filed Date: 6/29/21.
    Accession Number: 20210629-5213.
    Comments Due: 5 p.m. ET 7/20/21.

    Docket Numbers: ER21-2265-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Sec.  205(d) Rate Filing: 1885R11 Evergy Kansas
Central, Inc. NITSA NOA to be effective 9/1/2021.
    Filed Date: 6/29/21.
    Accession Number: 20210629-5222.
    Comments Due: 5 p.m. ET 7/20/21.

    Docket Numbers: ER21-2266-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Sec.  205(d) Rate Filing: 1893R11 Evergy Kansas
Central, Inc. NITSA NOA to be effective 9/1/2021.
    Filed Date: 6/29/21.
    Accession Number: 20210629-5240.
    Comments Due: 5 p.m. ET 7/20/21.

    Docket Numbers: ER21-2267-000.
    Applicants: New England Power Pool Participants Committee.
    Description: Sec.  205(d) Rate Filing: June 2021 Membership Filing
to be effective 6/1/2021.
    Filed Date: 6/30/21.
    Accession Number: 20210630-5001.
    Comments Due: 5 p.m. ET 7/21/21.

    Docket Numbers: ER21-2268-000.
    Applicants: City of Independence, Missouri.
    Description: Request For Waiver of Tariff Provisions, et al. of
City of Independence Missouri.
    Filed Date: 6/29/21.
    Accession Number: 20210629-5259.
    Comments Due: 5 p.m. ET 7/20/21.

    Docket Numbers: ER21-2269-000.
    Applicants: Orangeville Energy Storage LLC.
    Description: Sec.  205(d) Rate Filing: Revised Market-Based Rate
Tariff Filing to be effective 8/30/2021.
    Filed Date: 6/30/21.
    Accession Number: 20210630-5012.
    Comments Due: 5 p.m. ET 7/21/21.

    Docket Numbers: ER21-2270-000.
    Applicants: Jayhawk Wind, LLC.
    Description: Baseline eTariff Filing: Filing of Market-Based Rate
Application to be effective 8/30/2021.
    Filed Date: 6/30/21.
    Accession Number: 20210630-5018.
    Comments Due: 5 p.m. ET 7/21/21.

    Docket Numbers: ER21-2271-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Original WMPA, Service
Agreement No. 6105; Queue No. AG1-336 to be effective 6/21/2021.
    Filed Date: 6/30/21.
    Accession Number: 20210630-5032.
    Comments Due: 5 p.m. ET 7/21/21.

    Docket Numbers: ER21-2272-000.
    Applicants: Golden Hills Wind Farm, LLC.
    Description: Baseline eTariff Filing: Application for Market-Based
Rate Authorization, Request for Related Waivers to be effective 8/30/
2021.
    Filed Date: 6/30/21.
    Accession Number: 20210630-5044.
    Comments Due: 5 p.m. ET 7/21/21.

    The filings are accessible in the Commission's eLibrary system
(https://elibrary.ferc.gov/idmws/search/fercgensearch.asp) by 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: June 30, 2021.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2021-14469 Filed 7-6-21; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 49 (Tuesday, March 16, 2021)]
[Notices]
[Pages 14454-14455]
[FR Doc No: 2021-05323]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-D-0770]

Best Practices in Developing Proprietary Names for Human
Nonprescription Drug Products; Draft Guidance for Industry;
Availability; Reopening of the Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability; reopening of the comment period.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is reopening
the comment period for the notice entitled ``Best Practices in
Developing Proprietary Names for Human Nonprescription Drug Products;
Draft Guidance for Industry; Availability'' that appeared in the
Federal Register of December 9, 2020. The Agency is taking this action
to allow interested persons additional time to submit comments.

DATES: FDA is reopening the comment period for the notice published on
December 9, 2020 (85 FR 79187). Submit either electronic or written
comments on the draft guidance by June 14, 2021 to ensure that the
Agency considers your comment on this draft guidance before it begins
work on the final version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

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-2020-D-0770 for ``Best Practices in Developing Proprietary Names
for Human Nonprescription Drug Products.'' Received comments 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 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>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building,

4th Floor, Silver Spring, MD 20993-0002, or to the Office of
Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Danielle Harris, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 4461, Silver Spring, MD 20993-0002, 301-
796-4590; or Stephen Ripley, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm. 7301, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of December 9, 2020 (85 FR 79187), FDA
published a notice with a 60-day comment period to request comments on
the draft guidance for industry entitled ``Best Practices in Developing
Proprietary Names for Human Nonprescription Drug Products.''
    The Agency has received a request for an extension of the comment
period for the draft guidance to ensure that the Agency considers
additional comments on the draft guidance before it begins work on the
final version of the guidance. FDA has considered the request and is
reopening the comment period until June 14, 2021. The Agency believes
that an additional 90 days will allow adequate time for interested
persons to submit comments.

II. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, or https://www.regulations.gov.

    Dated: March 10, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-05323 Filed 3-15-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 78, Number 210 (Wednesday, October 30, 2013)]
[Notices]
[Pages 64956-64957]
[FR Doc No: 2013-25588]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0001]

Endocrinologic and Metabolic Drugs Advisory Committee; Notice of
Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
    Name of Committee: Endocrinologic and Metabolic Drugs Advisory
Committee.
    General Function of the Committee: To provide advice and
recommendations to the Agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on December 11, 2013, from
8 a.m. to 5 p.m.
    Location: FDA White Oak Campus, Building 31, the Great Room, White
Oak Conference Center (rm. 1503), 10903 New Hampshire Ave., Silver
Spring, MD 20993-0002. Information regarding special accommodations due
to a disability, visitor parking, and transportation may be accessed
at: http://www.fda.gov/AdvisoryCommittees/default.htm; under the
heading ``Resources for You,'' click on ``Public Meetings at the FDA
White Oak Campus.'' Please note that visitors to the White Oak Campus
must enter through Building 1.
    Contact Person: Karen Abraham-Burrell, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 31, rm. 2417, Silver Spring, MD 20993-0002,<PHONE_NUMBER>, FAX:
301-847-8533, email<EMAIL_ADDRESS>or FDA Advisory Committee
Information Line, 1-800-741-8138<PHONE_NUMBER> in the Washington, DC
area). A notice in the Federal Register about last minute modifications
that impact a previously announced advisory committee meeting cannot
always be published quickly enough to provide timely notice. Therefore,
you should always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate
advisory committee meeting link, or call the advisory committee
information line to learn about possible modifications before coming to
the meeting.
    Agenda: The committee will discuss the safety and efficacy of
biologic license application (BLA) 125390, metreleptin for injection,
sponsored by Amylin Pharmaceuticals, LLC, a wholly owned subsidiary of
Bristol-Myers Squibb. The proposed indication for metreleptin is the
treatment of metabolic disorders associated with lipodystrophy,
including diabetes mellitus and/or hypertriglyceridemia (elevated
triglyceride levels in the blood) in pediatric and adult patients with
inherited or acquired lipodystrophy. (Lipodystrophies are rare medical
conditions of abnormal loss of the body's fatty tissues.)
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
November 26, 2013. Oral presentations from the public will be scheduled
between approximately 1:30 p.m. and 2:30 p.m. Those individuals
interested in making formal oral presentations should notify the
contact person and submit a brief statement of the general nature of
the evidence or arguments they wish to present, the names and addresses
of proposed participants, and an indication of the approximate time
requested to make their presentation on or before November 18, 2013.
Time allotted for each presentation may be limited. If the number of
registrants requesting to speak is greater than can be reasonably
accommodated during the scheduled open public hearing session, FDA may
conduct a lottery to determine the speakers for the scheduled open
public hearing session. The contact person will notify interested
persons regarding their request to speak by November 19, 2013.
    Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee

meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Karen Abraham-
Burrell at least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: October 21, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2013-25588 Filed 10-29-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 88, Number 12 (Thursday, January 19, 2023)]
[Notices]
[Pages 3448-3449]
[FR Doc No: 2023-00893]

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SECURITIES AND EXCHANGE COMMISSION

[Investment Company Act Release No. 34804; 812-15402]

RBB Fund Trust and Element ETFs, LLC

AGENCY: Securities and Exchange Commission (``Commission'' or ``SEC'').

ACTION: Notice.

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    Notice of an application under section 6(c) of the Investment
Company Act of 1940 (``Act'') for an exemption from section 15(a) of
the Act and Rule 18f-2 thereunder, as well as from certain disclosure
requirements in rule 20a-1 under the Act, Item 19(a)(3) of Form N-1A,
Items 22(c)(1)(ii), 22(c)(1)(iii), 22(c)(8) and 22(c)(9) of Schedule
14A under the Securities Exchange Act of 1934, and sections 6-07(2)(a),
(b), and (c) of Regulation S-X (``Disclosure Requirements'').

Summary of Application:  The requested exemption would permit
Applicants to enter into and materially amend subadvisory agreements
with subadvisers without shareholder approval and would grant relief
from the Disclosure Requirements as they relate to fees paid to the
subadvisers.

Applicants:  RBB Fund Trust, and Element ETFs, LLC.

Filing Dates:  The application was filed on November 2, 2022, and
amended on December 16, 2022.

Hearing or Notification of Hearing:  An order granting the requested
relief

will be issued unless the Commission orders a hearing. Interested
persons may request a hearing on any application by emailing the SEC's
Secretary at [email protected] and serving the Applicants with
a copy of the request by email, if an email address is listed for the
relevant Applicant below, or personally or by mail, if a physical
address is listed for the relevant Applicant below. Hearing requests
should be received by the Commission by 5:30 p.m. on February 6, 2023,
and should be accompanied by proof of service on the Applicants, in the
form of an affidavit, or, for lawyers, a certificate of service.
Pursuant to rule 0-5 under the Act, hearing requests should state the
nature of the writer's interest, any facts bearing upon the
desirability of a hearing on the matter, the reason for the request,
and the issues contested. Persons who wish to be notified of a hearing
may request notification by emailing the Commission's Secretary.

ADDRESSES: The Commission: [email protected]. Applicants:
Steven Plump, [email protected]; and Aisha Hunt,
[email protected].

FOR FURTHER INFORMATION CONTACT: Lisa Ragen, Branch Chief, at (202)
551-6825 (Division of Investment Management, Chief Counsel's Office).

SUPPLEMENTARY INFORMATION: For Applicants' representations, legal
analysis, and conditions, please refer to Applicants' amended
application, dated December 16, 2022, which may be obtained via the
Commission's website by searching for the file number at the top of
this document, or for an Applicant using the Company name search field
on the SEC's EDGAR system. The SEC's EDGAR system may be searched at
https://www.sec.gov/edgar/searchedgar/legacy/companysearch.html. You
may also call the SEC's Public Reference Room at<PHONE_NUMBER>.

    For the Commission, by the Division of Investment Management,
under delegated authority.

    Dated: January 12, 2023.
Sherry R. Haywood,
Assistant Secretary.
[FR Doc. 2023-00893 Filed 1-18-23; 8:45 am]
BILLING CODE 8011-01-P