[Federal Register Volume 81, Number 247 (Friday, December 23, 2016)]
[Notices]
[Pages 94358-94359]
[FR Doc No: 2016-30974]

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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: EC17-48-000.
    Applicants: Nine Mile Point Nuclear Station, LLC.
    Description: Application of Nine Mile Point Nuclear Station, LLC
for Authorization under Section 203 of the Federal Power Act and
Request for Expedited Action.
    Filed Date: 12/16/16.
    Accession Number: 20161216-5196.
    Comments Due: 5 p.m. ET 1/6/17.

    Docket Numbers: EC17-49-000.
    Applicants: GridLiance West Transco LLC.
    Description: Application for Authorization to Acquire Transmission
Facilities Pursuant to Section 203 of GridLiance West Transco LLC.

    Filed Date: 12/16/16.
    Accession Number: 20161219-5103.
    Comments Due: 5 p.m. ET 1/6/17.

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

    Docket Numbers: ER16-2411-002.
    Applicants: Luning Energy Holdings LLC.
    Description: Triennial Report for Northwest region of Luning Energy
Holdings LLC.
    Filed Date: 12/16/16.
    Accession Number: 20161216-5186.
    Comments Due: 5 p.m. ET 2/14/17.

    Docket Numbers: ER16-2412-002.
    Applicants: Luning Energy LLC.
    Description: Triennial Report for Northwest region of Luning Energy
LLC.
    Filed Date: 12/16/16.
    Accession Number: 20161216-5185.
    Comments Due: 5 p.m. ET 2/14/17.

    Docket Numbers: ER16-2514-001.
    Applicants: Public Service Company of Colorado.
    Description: Compliance filing: OATT Schedules 4 & 9 Compliance to
be effective 1/1/2017.
    Filed Date: 12/15/16.
    Accession Number: 20161215-5098.
    Comments Due: 5 p.m. ET 1/5/17.

    Docket Numbers: ER17-173-000.
    Applicants: Wabash Valley Power Association, Inc.
    Description: Supplement to October 24, 2016 Request for Revised and
Additional Depreciation Rates of Wabash Valley Power Association, Inc.
    Filed Date: 12/16/16.
    Accession Number: 20161216-5188.
    Comments Due: 5 p.m. ET 12/23/16.

    Docket Numbers: ER17-468-001.
    Applicants: Ohio Valley Electric Corporation.
    Description: Compliance filing: Errata to Amendment J, K and P to
be effective 10/14/2016.
    Filed Date: 12/16/16.
    Accession Number: 20161216-5182.
    Comments Due: 5 p.m. ET 1/6/17.

    Docket Numbers: ER17-567-000.
    Applicants: Duke Energy Progress, LLC.
    Description: Sec.  205(d) Rate Filing: Southampton Solar Affected
System Operating Agreement to be effective 1/19/2017.
    Filed Date: 12/16/16.
    Accession Number: 20161216-5145.
    Comments Due: 5 p.m. ET 1/6/17.

    Docket Numbers: ER17-568-000.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Sec.  205(d) Rate Filing: 2016-12-16_Attachment X-
Quarterly Operating Limits to be effective 2/15/2017.
    Filed Date: 12/16/16.
    Accession Number: 20161216-5155.
    Comments Due: 5 p.m. ET 1/6/17.

    Docket Numbers: ER17-569-000.
    Applicants: National Choice Energy LLC.
    Description: Baseline eTariff Filing: Baseline New to be effective
12/30/2016.
    Filed Date: 12/16/16.
    Accession Number: 20161216-5158.
    Comments Due: 5 p.m. ET 1/6/17.

    Docket Numbers: ER17-570-000.
    Applicants: Pacific Gas and Electric Company.
    Description: Tariff Cancellation: Notices of Termination of
Tranquillity 8 and Mustang 2 E&P Agreements to be effective 11/2/2016.
    Filed Date: 12/19/16.
    Accession Number: 20161219-5000.
    Comments Due: 5 p.m. ET 1/9/17.

    Docket Numbers: ER17-571-000.
    Applicants: Entergy Mississippi, Inc.
    Description: Notice of Termination of Lease Agreement of Entergy
Mississippi, Inc.
    Filed Date: 12/15/16.
    Accession Number: 20161215-5314.
    Comments Due: 5 p.m. ET 1/5/17.

    Docket Numbers: ER17-572-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Tariff Cancellation: Notice of Cancellation of WMPA SA
No. 2939, Queue No. W1-114 to be effective 12/19/2016.
    Filed Date: 12/19/16.
    Accession Number: 20161219-5093.
    Comments Due: 5 p.m. ET 1/9/17.

    Docket Numbers: ER17-573-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Tariff Cancellation: Notice of Cancellation of WMPA SA
No. 2938, Queue No. W1-115 to be effective 12/19/2016.
    Filed Date: 12/19/16.
    Accession Number: 20161219-5116.
    Comments Due: 5 p.m. ET 1/9/17.

    Docket Numbers: ER17-574-000.
    Applicants: Duke Energy Progress, LLC, Duke Energy Carolinas, LLC.
    Description: Compliance filing: Compliance Filing EL16-29 and EL16-
30 to be effective 1/1/2016.
    Filed Date: 12/19/16.
    Accession Number: 20161219-5127.
    Comments Due: 5 p.m. ET 1/9/17.

    Docket Numbers: ER17-575-000.
    Applicants: Tucson Electric Power Company.
    Description: Sec.  205(d) Rate Filing: Cancellation of Service
Schedule B under Rate Schedule No. 125 to be effective 11/21/2016.
    Filed Date: 12/19/16.
    Accession Number: 20161219-5160.
    Comments Due: 5 p.m. ET 1/9/17.

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

    Docket Numbers: ES17-8-000.
    Applicants: MidAmerican Energy Company.
    Description: Application under Section 204 of the Federal Power Act
for Authorization to issue and sell debt securities of MidAmerican
Energy Company.
    Filed Date: 12/16/16.
    Accession Number: 20161216-5199.
    Comments Due: 5 p.m. ET 1/6/17.

    Docket Numbers: ES17-9-000.
    Applicants: GridLiance West Transco LLC.
    Description: Application Under Section 204 of the Federal Power Act
for Authorization to Issue Securities of GridLiance West Transco LLC.
    Filed Date: 12/16/16.
    Accession Number: 20161219-5110.
    Comments Due: 5 p.m. ET 1/6/17.

    Take notice that the Commission received the following public
utility holding company filings:

    Docket Numbers: PH17-5-000.
    Applicants: Enbridge Inc.
    Description: Enbridge Inc. submits FERC 65-A Waiver Notification
and Notice of Material Change in Facts.
    Filed Date: 12/16/16.
    Accession Number: 20161216-5191.
    Comments Due: 5 p.m. ET 1/6/17.

    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 19, 2016.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2016-30974 Filed 12-22-16; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 84, Number 57 (Monday, March 25, 2019)]
[Notices]
[Pages 11103-11105]
[FR Doc No: 2019-05658]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-0983]

Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting;
Establishment of a Public Docket; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of a public docket; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming
public advisory committee meeting of the Pulmonary-Allergy Drugs
Advisory Committee. The general function of the committee is to provide
advice and recommendations to FDA on regulatory issues. The meeting
will be open to the public. FDA is establishing a docket for public
comment on this document.

DATES: The meeting will be held on May 8, 2019, from 8 a.m. to 5 p.m.

ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-
0002. Answers to commonly asked questions including information
regarding special accommodations due to a disability, visitor parking,
and transportation may be accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
    FDA is establishing a docket for public comment on this meeting.
The docket number is FDA-2019-N-0983. The docket will close on May 7,
2019. Submit either electronic or written comments on this public
meeting by May 7, 2019. 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 May 7, 2019. 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.
    Comments received on or before April 24, 2019, will be provided to
the committee. Comments received after that date will be taken into
consideration by FDA.
    You may submit comments 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-2019-N-0983 for ``Pulmonary-Allergy Drugs Advisory Committee;
Notice of Meeting; Establishment of a Public Docket; Request for
Comments.'' 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.'' FDA 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 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 the 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: Cindy Chee, 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 FDA's website at https://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.

SUPPLEMENTARY INFORMATION:
    Agenda: The committee will discuss new drug application (NDA)
202049, for mannitol inhalation powder, for oral inhalation submitted
by Chiesi USA, Inc., for the proposed indication of management of
cystic fibrosis to improve pulmonary function in patients 18 years of
age and older in conjunction with standard therapies.
    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 website 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 website after the meeting. Background material is
available at https://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.
All electronic and written submissions submitted to the Docket (see the
ADDRESSES section) on or before April 24, 2019, will be provided to the
committee. Oral presentations from the public will be scheduled between
approximately 1 p.m. and 2 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 April 16, 2019. 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 April 17, 2019.
    Persons attending FDA's advisory committee meetings are advised
that FDA is not responsible for providing access to electrical outlets.
    For press inquiries, please contact the Office of Media Affairs at
<EMAIL_ADDRESS>or<PHONE_NUMBER>.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
disabilities. If you require accommodations due to a disability, please
contact Cindy Chee at least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our website at https://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: March 20, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-05658 Filed 3-22-19; 8:45 am]
 BILLING CODE 4164-01-P