[Federal Register Volume 80, Number 161 (Thursday, August 20, 2015)]
[Notices]
[Pages 50619-50620]
[FR Doc No: 2015-20575]

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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
corporate filings:
    Docket Numbers: EC15-189-000.
    Applicants: Prairie Breeze Wind Energy LLC, Prairie Breeze Wind
Energy II LLC, Prairie Breeze Wind Energy III LLC.
    Description: Application for Authorization Under Section 203 of the
Federal Power Act and Request for Waivers and Expedited Action of
Prairie Breeze Wind Energy LLC, et al.
    Filed Date: 8/14/15.
    Accession Number: 20150814-5147.
    Comments Due: 5 p.m. ET 9/4/15.

    Take notice that the Commission received the following exempt
wholesale generator filings:
    Docket Numbers: EG15-115-000.
    Applicants: Pavant Solar, LLC.
    Description: Notice of Self-certification of Exempt Wholesale
Generator Status of Pavant Solar, LLC.
    Filed Date: 8/14/15.
    Accession Number: 20150814-5081.
    Comments Due: 5 p.m. ET 9/4/15.

    Docket Numbers: EG15-116-000.
    Applicants: Latigo Wind Park, LLC.
    Description: Notice of Self-Certification of Exempt Wholesale
Generator Status of Latigo Wind Park, LLC under EG15-116.
    Filed Date: 8/14/15.
    Accession Number: 20150814-5173.
    Comments Due: 5 p.m. ET 9/4/15.

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

    Docket Numbers: ER10-2137-013; ER14-2798-005; ER14-2799-005; ER12-
161-012; ER12-164-012; ER15-1873-002; ER12-645-014; ER10-2130-013;
ER10-2131-013; ER10-2138-013; ER10-2139-013; ER10-2140-013; ER10-2141-
013; ER14-2187-007; ER11-4044-014; ER11-4046-013; ER10-2129-010; ER10-
2134-010; ER10-2136-011; ER15-103-004; ER10-2127-012; ER10-2125-013;
ER14-25-009; ER15-1041-002; ER10-2133-013; ER10-2135-010; ER10-2124-
012; ER11-3872-014; ER10-2132-012; ER10-2128-012; ER10-2764-012.
    Applicants: Beech Ridge Energy LLC, Beech Ridge Energy II LLC,
Beech Ridge Energy Storage LLC, Bishop Hill Energy LLC, Bishop Hill
Energy III LLC, Buckeye Wind Energy LLC, California Ridge Wind Energy
LLC, Forward Energy LLC, Grand Ridge Energy LLC, Grand Ridge Energy II
LLC, Grand Ridge Energy III LLC, Grand Ridge Energy IV LLC, Grand Ridge
Energy V LLC, Grand Ridge Energy Storage LLC, Gratiot County Wind LLC,
Gratiot County Wind II LLC, Grays Harbor Energy LLC, Hardee Power
Partners Limited, Invenergy Cannon Falls LLC, Invenergy Nelson LLC,
Invenergy TN LLC, Judith Gap Energy LLC, Prairie Breeze Wind Energy
LLC, Prairie Breeze Wind Energy II LLC, Sheldon Energy LLC, Spindle
Hill Energy LLC, Spring Canyon Energy LLC, Stony Creek Energy LLC,
Willow Creek Energy LLC, Wolverine Creek Energy LLC, Vantage Wind
Energy LLC.
    Description: Notification of Change in Facts of Beech Ridge Energy
LLC, et al.
    Filed Date: 8/14/15.
    Accession Number: 20150814-5186.
    Comments Due: 5 p.m. ET 9/4/15.

    Docket Numbers: ER15-517-003.
    Applicants: ISO New England Inc., Cross-Sound Cable Company, LLC.
    Description: Compliance filing: Standards for Bus Prac & Comm
Protocols Cross Sound Cable Errata Filing to be effective 5/15/2015.
    Filed Date: 8/14/15.
    Accession Number: 20150814-5130.
    Comments Due: 5 p.m. ET 8/24/15.

    Docket Numbers: ER15-2441-000.
    Applicants: California Independent System Operator Corporation.
    Description: Section 205(d) Rate Filing: 2015-8-13_Implement
Reliability Coordinator Charges Settlement Process to be effective 10/
15/2015.
    Filed Date: 8/13/15.
    Accession Number: 20150813-5219.
    Comments Due: 5 p.m. ET 9/3/15.

    Docket Numbers: ER15-2442-000.
    Applicants: ITC Midwest LLC.
    Description: Section 205(d) Rate Filing: Filing of CIAC Agreement
with Maquoketa Valley to be effective 10/12/2015.
    Filed Date: 8/13/15.
    Accession Number: 20150813-5223.
    Comments Due: 5 p.m. ET 9/3/15.

    Docket Numbers: ER15-2443-000.
    Applicants: ISO New England Inc.
    Description: ISO New England Inc. submits Second Quarter 2015
Capital Budget Report.
    Filed Date: 8/13/15.
    Accession Number: 20150813-5248.
    Comments Due: 5 p.m. ET 9/3/15.

    Docket Numbers: ER15-2444-000.
    Applicants: Idaho Power Company.
    Description: Idaho Power Company submits Average System Cost Filing
for Sales of Electric Power to the Bonneville Power Administration, FY
2016-2017.
    Filed Date: 8/13/15.
    Accession Number: 20150813-5249.
    Comments Due: 5 p.m. ET 9/3/15.

    Docket Numbers: ER15-2445-000.
    Applicants: Puget Sound Energy, Inc.
    Description: Puget Sound Energy, Inc. submits Average System Cost
Filing for Sales of Electric Power to the Bonneville Power
Administration, FY 2016-2017.
    Filed Date: 8/13/15.
    Accession Number: 20150813-5250.
    Comments Due: 5 p.m. ET 9/3/15.

    Docket Numbers: ER15-2446-000.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Section 205(d) Rate Filing: 2015-08-14_SA 2828
MidAmerican Energy-Farmers City Wind GIA (R26) to be effective 8/15/
2015.
    Filed Date: 8/14/15.
    Accession Number: 20150814-5067.
    Comments Due: 5 p.m. ET 9/4/15.

    Docket Numbers: ER15-2447-000.
    Applicants: Midcontinent Independent System Operator, Inc., Union
Electric Company.
    Description: Compliance filing: 2015-08-14_Union Electric
Depreciation Rate Compliance Filing to be effective 6/1/2015.
    Filed Date: 8/14/15.
    Accession Number: 20150814-5082.
    Comments Due: 5 p.m. ET 9/4/15.

    Docket Numbers: ER15-2448-000.
    Applicants: Prairie Breeze Wind Energy II LLC.
    Description: Section 205(d) Rate Filing: Filing of Assignment, Co-
Tenancy, and Shared Facilities Agreement to be effective 8/15/2015.
    Filed Date: 8/14/15.
    Accession Number: 20150814-5125.
    Comments Due: 5 p.m. ET 9/4/15.

    Docket Numbers: ER15-2449-000.
    Applicants: Prairie Breeze Wind Energy III LLC.
    Description: Section 205(d) Rate Filing: Filing of Assignment, Co-
Tenancy, and Shared Facilities Agreement to be effective 8/15/2015.
    Filed Date: 8/14/15.
    Accession Number: 20150814-5126.
    Comments Due: 5 p.m. ET 9/4/15.

    Docket Numbers: ER15-2450-000.
    Applicants: Prairie Breeze Wind Energy LLC.
    Description: Section 205(d) Rate Filing: Filing of Assignment, Co-
Tenancy, and Shared Facilities Agreement to be effective 8/15/2015.
    Filed Date: 8/14/15.
    Accession Number: 20150814-5128.
    Comments Due: 5 p.m. ET 9/4/15.

    Docket Numbers: ER15-2451-000.
    Applicants: Maine Electric Power Company, Inc.

    Description: Section 205(d) Rate Filing: Construction Agreement
between MEPCO and Number Nine Wind Farm LLC to be effective 8/13/2015.
    Filed Date: 8/14/15.
    Accession Number: 20150814-5129.
    Comments Due: 5 p.m. ET 9/4/15.

    Docket Numbers: ER15-2452-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Section 205(d) Rate Filing: Revisions to Attachment AE
Section 3.9 Net Benefit Test Clean-up to be effective 3/1/2015.
    Filed Date: 8/14/15.
    Accession Number: 20150814-5179.
    Comments Due: 5 p.m. ET 9/4/15.

    Docket Numbers: ER15-2453-000.
    Applicants: Passadumkeag Windpark, LLC.
    Description: Baseline eTariff Filing: Application for Market Based
Rate Authority and Request for Waivers to be effective 9/18/2015.
    Filed Date: 8/14/15.
    Accession Number: 20150814-5182.
    Comments Due: 5 p.m. ET 9/4/15.

    Docket Numbers: ER15-2454-000.
    Applicants: Otter Tail Power Company.
    Description: Section 205(d) Rate Filing: Filing of Certificate of
Concurrence--TCRA to be effective 9/1/2015.
    Filed Date: 8/14/15.
    Accession Number: 20150814-5218.
    Comments Due: 5 p.m. ET 9/4/15.

    Docket Numbers: ER15-2455-000.
    Applicants: Koch Energy Services, LLC.
    Description: Baseline eTariff Filing: Application for Market-Based
Rate Authorization to be effective 10/1/2015.
    Filed Date: 8/14/15.
    Accession Number: 20150814-5221.
    Comments Due: 5 p.m. ET 9/4/15.

    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: August 14, 2015.
Kimberly D. Bose,
Secretary.
[FR Doc. 2015-20575 Filed 8-19-15; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 90 (Wednesday, May 12, 2021)]
[Notices]
[Pages 26047-26048]
[FR Doc No: 2021-10066]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-6113]

E9(R1) Statistical Principles for Clinical Trials: Addendum:
Estimands and Sensitivity Analysis in Clinical Trials; International
Council for Harmonisation; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry entitled ``E9(R1)
Statistical Principles for Clinical Trials: Addendum: Estimands and
Sensitivity Analysis in Clinical Trials.'' The guidance was prepared
under the auspices of the International Council for Harmonisation
(ICH), formerly the International Conference on Harmonisation. The
guidance clarifies, updates, and extends the guidance for industry ``E9
Statistical Principles for Clinical Trials'' issued in September 1998
in two main areas. Concerning estimands, it provides a framework for
discussion of how the aims of a trial relate to the proposed
statistical analysis. Concerning sensitivity analysis, it discusses how
to use additional analyses to address concerns about the validity of
assumptions underlying the main analysis. The guidance is intended to
better align the choice of statistical methods with questions of
regulatory importance and so to improve the reliability of decisions
about and representations of the effects of medical products. The
guidance replaces the draft guidance issued on October 31, 2017.

DATES: The announcement of the guidance is published in the Federal
Register on May 12, 2021.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances 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-2017-D-6113 for ``E9(R1) Statistical Principles for Clinical
Trials: Addendum: Estimands and Sensitivity Analysis in Clinical
Trials.'' 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 this 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 the Office of
Communication, Outreach and Development, Center for Biologics
Evaluation and Research (CBER), 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. The guidance
may also be obtained by mail by calling CBER at 1-800-835-4709 or 240-
402-8010. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.

FOR FURTHER INFORMATION CONTACT:
    Regarding the guidance: Scott Goldie, Center for Drug Evaluation
and Research, Food and Drug Administration, Bldg. 21, Rm. 3557, Silver
Spring, MD 20993-0002,<PHONE_NUMBER><EMAIL_ADDRESS>or
Stephen Ripley, Center for Biologics Evaluation and Research, Food and
Drug Administration, Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002,
240-402-7911.
    Regarding the ICH: Jill Adleberg, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6364, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``E9(R1) Statistical Principles for Clinical Trials: Addendum:
Estimands and Sensitivity Analysis in Clinical Trials.'' The guidance
was prepared under the auspices of ICH. ICH has the mission of
achieving greater regulatory harmonization worldwide to ensure that
safe, effective, high-quality medicines are developed, registered, and
maintained in the most resource-efficient manner.
    By harmonizing the regulatory requirements in regions around the
world, ICH guidelines have substantially reduced duplicative clinical
studies, prevented unnecessary animal studies, standardized the
reporting of important safety information, standardized marketing
application submissions, and made many other improvements in the
quality of global drug development and manufacturing and the products
available to patients.
    The six Founding Members of the ICH are FDA; the Pharmaceutical
Research and Manufacturers of America; the European Commission; the
European Federation of Pharmaceutical Industries Associations; the
Japanese Ministry of Health, Labour, and Welfare; and the Japanese
Pharmaceutical Manufacturers Association. The Standing Members of the
ICH Association include Health Canada and Swissmedic. Additionally, the
Membership of ICH has expanded to include other regulatory authorities
and industry associations from around the world (refer to https://www.ich.org/).
    ICH works by involving technical experts from both regulators and
industry parties in detailed technical harmonization work and the
application of a science-based approach to harmonization through a
consensus-driven process that results in the development of ICH
guidelines. The regulators around the world are committed to
consistently adopting these consensus-based guidelines, realizing the
benefits for patients and for industry.
    As a Founding Regulatory Member of ICH, FDA plays a major role in
the development of each of the ICH guidelines, which FDA then adopts
and issues as guidance for industry. FDA's guidance documents do not
establish legally enforceable responsibilities. Instead, they describe
the Agency's current thinking on a topic and should be viewed only as
recommendations, unless specific regulatory or statutory requirements
are cited.
    In the Federal Register of October 31, 2017 (82 FR 50433), FDA
published a notice announcing the availability of a draft guidance
entitled ``E9(R1) Statistical Principles for Clinical Trials: Addendum:
Estimands and Sensitivity Analysis in Clinical Trials.'' The notice
gave interested persons an opportunity to submit comments by April 30,
2018.
    After consideration of the comments received and revisions to the
guideline, a final draft of the guideline was submitted to the ICH
Assembly and endorsed by the regulatory agencies in November 2019.
    This guidance finalizes the draft guidance issued on October 31,
2017. The guidance provides clarification on statistical principles for
clinical trials and an update on the choice of estimand to describe a
framework for planning, conducting, and interpreting sensitivity
analyses of clinical trial data. The focus of the guidance is on
statistical principles related to estimands and sensitivity analysis
for confirmatory clinical trials. The guidance provides recommendations
for aligning the choice of statistical methods with the goals of a
clinical trial; on communicating the rationale for such choices to FDA;
and on using sensitivity analysis to characterize the robustness of the
conclusions to plausible deviations from the assumptions of the main
analysis. Revisions made following the public comment period are
intended to clarify content within the guidance; however, no new
concepts are presented in the revised version.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``E9(R1) Statistical Principles for Clinical
Trials: Addendum: Estimands and Sensitivity Analysis in Clinical
Trials.'' It does not establish any rights for any person and is not
binding on FDA or the public. You can use an alternative approach if it
satisfies the requirements of the applicable statutes and regulations.

II. Electronic Access

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

    Dated: May 7, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-10066 Filed 5-11-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 81, Number 181 (Monday, September 19, 2016)]
[Notices]
[Page 64226]
[FR Doc No: 2016-22659]

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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meeting

    Notice is hereby given, pursuant to the provisions of the
Government in the Sunshine Act, Public Law 94-409, that the Securities
and Exchange Commission will hold a closed meeting on Thursday,
September 22, 2016 at 2 p.m.
    Commissioners, Counsel to the Commissioners, the Secretary to the
Commission, and recording secretaries will attend the closed meeting.
Certain staff members who have an interest in the matters also may be
present.
    The General Counsel of the Commission, or her designee, has
certified that, in her opinion, one or more of the exemptions set forth
in 5 U.S.C. 552b(c)(3), (5), (7), 9(B) and (10) and 17 CFR
200.402(a)(3), (a)(5), (a)(7), (a)(9)(ii) and (a)(10), permit
consideration of the scheduled matter at the closed meeting.
    Commissioner Piwowar, as duty officer, voted to consider the items
listed for the closed meeting in closed session.
    The subject matter of the closed meeting will be:
    Institution and settlement of injunctive actions;
    Institution and settlement of administrative proceedings; and
    Other matters relating to enforcement proceedings.
    At times, changes in Commission priorities require alterations in
the scheduling of meeting items.
    For further information and to ascertain what, if any, matters have
been added, deleted or postponed, please contact Brent J. Fields from
the Office of the Secretary at<PHONE_NUMBER>.

    Dated: September 15, 2016.
Brent J. Fields,
Secretary.
[FR Doc. 2016-22659 Filed 9-15-16; 4:15 pm]
 BILLING CODE 8011-01-P