[Federal Register Volume 83, Number 179 (Friday, September 14, 2018)]
[Notices]
[Pages 46742-46745]
[FR Doc No: 2018-19992]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-2565]

510(k) Third-Party Review Program; Draft Guidance for Industry,
Food and Drug Administration Staff, and Third-Party Review
Organizations; 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the availability of the draft guidance entitled ``510(k) Third-Party
Review Program; Draft Guidance for Industry, Food and Drug
Administration Staff, and Third-Party Review Organizations.'' This
draft guidance provides a comprehensive look into FDA's current
thinking regarding the 510(k) Third-Party (3P) Review Program
authorized under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Under the FDA Reauthorization Act of 2017 (FDARA), FDA was directed to
issue draft guidance on the factors that will be used in determining
whether a class I or class II device type, or subset of such device
types, is eligible for review by an accredited person. The 3P Review
Program is intended to allow review of devices by 3P Review
Organizations to provide manufacturers of these devices an alternative
review process that allows FDA to best utilize our resources on higher
risk devices. This draft guidance is not final nor is it in effect at
this time.

DATES: Submit either electronic or written comments on the draft
guidance by December 13, 2018 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance. Submit either electronic or written comments
on the collection of information by November 13, 2018.

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-2016-D-2565 for ``510(k) Third-Party Review Program.'' 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.
     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.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the draft guidance document entitled
``510(k) Third-Party Review Program'' to the Office of the Center
Director, Guidance and Policy Development, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your
request.

FOR FURTHER INFORMATION CONTACT: Gregory Pishko, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5659, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA's implementation of section 523 of the FD&C Act (21 U.S.C.
360m) establishes a process for recognition of qualified third parties
to conduct the initial review of premarket notification (510(k))
submissions for certain low-to-moderate risk devices eligible under the
3P Review Program. Under FDARA (Pub. L. 115-52), the criteria used to
establish device eligibility in the 3P Review Program changed and FDA
was directed to issue draft guidance on the factors that will be used
in determining whether a class I or class II device type, or subset of
such device types, is eligible for review by an accredited person. The
objectives of this draft guidance are: (1) To describe the factors FDA
will use in determining device type eligibility for review by 3P Review
Organizations; (2) to outline FDA's process for the recognition, re-
recognition, suspension, and withdrawal of recognition for 3P Review
Organizations; and (3) to ensure consistent quality of work among 3P
Review Organizations through Medical Device User Fee Amendments IV
commitments authorized under FDARA. This draft guidance also outlines
FDA's current thinking on leveraging the International Medical Device
Regulators Forum's requirements for the Medical Device Single Audit
Program.
    Upon issuance, this draft guidance will replace the draft guidance
entitled ``510(k) Third-Party Review Program--Draft Guidance for
Industry, Food and Drug Administration Staff, and Third-Party Review
Organizations'' (81 FR 62744) issued on September 12, 2016.
    This draft guidance, when finalized, will supersede
``Implementation of Third-Party Programs Under the FDA Modernization
Act of 1997; Final Guidance for Staff, Industry, and Third Parties''
issued on February 2, 2001, and ``Guidance for Third Parties and FDA
Staff; Third-Party Review of Premarket Notifications'' issued on
September 28, 2004.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on the ``510(k)
Third-Party Review Program.'' 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. This guidance is not subject to Executive
Order 12866.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do
so by downloading an electronic copy from the internet. A search
capability for all Center for Devices and Radiological Health guidance
documents is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. This
guidance document is also available at https://www.regulations.gov.
Persons unable to download an electronic copy of ``510(k) Third-Party
Review Program'' may send an email request to [email protected]
to receive an electronic copy of the document. Please use the document
number 17-028 to identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    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 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.

510(k) Third-Party Review Program (Formerly Medical Devices; Third-
Party Review Under the Food and Drug Administration Modernization Act)

OMB Control Number 0910-0375--Revision

    Information collections (ICs) associated with the 510(k) Third-
Party Review Program have been approved under OMB control number 0910-
0375, ``Medical Devices; Third-Party Review Under the Food and Drug
Administration Modernization Act.'' When finalized, the draft guidance
entitled ``510(k) Third-Party Review Program; Draft Guidance for
Industry, Food and Drug Administration Staff, and Third-Party Review
Organizations'' will necessitate revisions to the burden estimates in
OMB control number 0910-0375.
    Section 210 of the Food and Drug Administration Modernization Act
(FDAMA) established section 523 of the FD&C Act (21 U.S.C. 360m),
directing FDA to accredit persons in the private sector to review
certain premarket notifications (510(k)s). Participation in this third-
party review program by accredited persons is entirely voluntary. A
third party wishing to participate will submit a request for
accreditation to FDA. Accredited third-party reviewers have the ability
to review a manufacturer's 510(k) submission for selected devices.
After reviewing a submission, the reviewer will forward a copy of the
510(k) submission, along with the reviewer's documented review and
recommendation, to FDA. Third-party reviewers should maintain records
of their 510(k) reviews and a copy of the 510(k) for a reasonable
period of time, usually a period of 3 years.
    Respondents to this information collection are businesses or other
for-profit organizations.
    FDA estimates the burden of this IC as follows:

Estimated Annual Reporting Burden

    Requests for accreditation (initial): On average, the Agency has
received one application for accreditation for 3P review per year.
There is no change to this IC from the currently approved burden
estimate.
    Requests for accreditation (re-recognition): We have added an IC
for re-recognition requests to be consistent with the guidance which
states that requests for re-recognition will be handled in the same
manner as initial recognition requests. Based on the estimated number
of 3P Review Organizations (7) and the frequency of re-recognition (3
years), we expect to receive approximately 2 re-recognition requests
per year. We expect the average burden per response to be the same as
an initial request (24 hours).
    510(k) reviews conducted by accredited third parties: Based on
FDA's recent experience with this program, we estimate the number of
510(k)s submitted for third-party review to be 147 annually;
approximately 21 annual reviews for each of the 7 3P Review
Organizations. This IC has been adjusted based on current trends,
however, there is no program change to this IC.
    Complaints: The guidance recommends that the 3P Review Organization
should forward to FDA information on any complaint (e.g.,
whistleblowing) it receives about a 510(k) submitter that could
indicate an issue related to the safety or effectiveness of a medical
device or a public health risk. Therefore, we have added an IC for
complaints to the reporting burden. We expect to receive one forwarded
complaint per year. Based on similar information collections, we
estimate the average burden per complaint to be 0.25 hours (15
minutes).

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
            Activity                 Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
Requests for accreditation                     1               1               1              24              24
 (initial) \3\..................
Requests for accreditation (re-                2               1               2              24              48
 recognition) \5\...............
510(k) reviews conducted by                    7              21             147              40           5,880
 accredited third parties \4\...
Complaints \5\..................               1               1               1            0.25               1
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           5,952
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this IC.
(15 minutes)

Estimated Annual Recordkeeping Burden

    510(k) Reviews: 3P Review Organizations should retain copies of all
510(k) reviews and associated correspondence. Based on FDA's recent
experience with this program, we estimate the number of 510(k)s
submitted for 3P review to be 147 annually; approximately 21 annual
reviews for each of the 7 3P Review Organizations. We estimate the
average burden per recordkeeping to be 10 hours. The estimated number
of records and recordkeepers have been adjusted based on current
trends, however, there is no program change to this IC.
    Records regarding qualifications to receive FDA recognition as a 3P
Review Organization: Under section 704(f) of the FD&C Act (21 U.S.C.
374(f)), a 3P Review Organization must maintain records that support
their initial and continuing qualifications to receive FDA recognition,
including documentation of the training and qualifications of the 3P
Review Organization and its personnel; the procedures used by the 3P
Review Organization for handling confidential information; the
compensation arrangements made by the 3P Review Organization; and the
procedures used by the 3P Review Organization to identify and avoid
conflicts of interest. Additionally, the draft guidance states that 3P
Review Organizations should retain information on the identity and
qualifications of all personnel who contributed to the technical review
of each 510(k) submission and other relevant records. Therefore, we
have added an IC for ``Records regarding qualification to receive FDA
recognition as a 3P Review Organization.'' Because most of the burden
of compiling the records is expressed in the reporting burden for
requests for accreditation, we estimate the maintenance of such records
to be 1 hour per recordkeeping annually.
    Recordkeeping system regarding complaints: Section 523(b)(3)(E)(iv)
of the FD&C Act requires 3P Review Organizations to agree in writing
that they will promptly respond and attempt to resolve complaints
regarding their activities. The draft guidance

recommends that 3P Review Organizations establish a recordkeeping
system for tracking the submission of those complaints and how those
complaints were resolved, or attempted to be resolved. Therefore, we
have added an IC for ``Recordkeeping system regarding complaints.''
Based on our experience with the program and the recommendations in the
guidance, we estimate the average burden per recordkeeping to be 2
hours.

                               Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                    Average burden
            Activity                 Number of      records per    Total annual         per         Total hours
                                   recordkeepers   recordkeeper       records      recordkeeping
----------------------------------------------------------------------------------------------------------------
510(k) reviews \3\..............               7              21             147              10           1,470
Records regarding qualifications               7               1               7               1               7
 to receive FDA recognition as a
 3P Review Organization \4\.....
Recordkeeping system regarding                 7               1               7               2              14
 complaints \4\.................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           1,491
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this IC.

    We revised our estimates for OMB control number 0910-0375 by adding
new ICs, changing the title of the ICR, and adjusting the existing ICs
based on current trends. Despite the addition of new ICs, the estimated
burden reflects an overall decrease of 5,581 hours. We attribute this
adjustment to a decrease in the number of submissions we received over
the last few years.
    The draft guidance also refers to previously approved ICs found in
FDA regulations. The ICs in 21 CFR part 807, subpart E have been
approved under OMB control number 0910-0120; the ICs regarding 3P
Review of medical devices under FDAMA have been approved under OMB
control number 0910-0375; the ICs for the device appeals processes have
been approved under OMB control number 0910-0738; the ICs in the
guidance document ``Requests for Feedback on Medical Device
Submissions: The Pre-Submission Program and Meetings with Food and Drug
Administration Staff'' have been approved under OMB control number
0910-0756.

    Dated: September 10, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-19992 Filed 9-13-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 83, Number 30 (Tuesday, February 13, 2018)]
[Notices]
[Pages 6172-6174]
[FR Doc No: 2018-03013]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Sunshine Act Meeting Notice

    The following notice of meeting is published pursuant to section
3(a) of the government in the Sunshine Act (Pub. L. 94-409), 5 U.S.C.
552b:

AGENCY HOLDING MEETING: Federal Energy Regulatory Commission.

DATE AND TIME: February 15, 2018, 10:00 a.m.

PLACE: Room 2C, 888 First Street NE, Washington, DC 20426.

STATUS: Open.

MATTERS TO BE CONSIDERED: Agenda.
    * NOTE--Items listed on the agenda may be deleted without further
notice.

CONTACT PERSON FOR MORE INFORMATION: Kimberly D. Bose, Secretary,
Telephone<PHONE_NUMBER>.
    For a recorded message listing items struck from or added to the
meeting, call<PHONE_NUMBER>.
    This is a list of matters to be considered by the Commission. It
does not include a listing of all documents relevant to the items on
the agenda. All public documents, however, may be viewed on line at the
Commission's website at http://ferc.capitolconnection.org/ sing the
eLibrary link, or may be examined in the Commission's Public Reference
Room.

                                                 1040th--Meeting
----------------------------------------------------------------------------------------------------------------
        Item No.                     Docket No.                                    Company
----------------------------------------------------------------------------------------------------------------
                                                 Administrative
----------------------------------------------------------------------------------------------------------------
A-1.....................  AD18-1-000......................  Agency Administrative Matters.
A-2.....................  AD18-2-000......................  Customer Matters, Reliability, Security and Market
                                                             Operations.
----------------------------------------------------------------------------------------------------------------
                                                    Electric
----------------------------------------------------------------------------------------------------------------
E-1.....................  RM16-23-000, AD16-20-000........  Electric Storage Participation in Markets Operated
                                                             by Regional Transmission Organizations and
                                                             Independent System Operators. Electric Storage
                                                             Participation in Regions with Organized Wholesale
                                                             Electric Markets.
E-2.....................  RM16-6-000......................  Essential Reliability Services and the Evolving Bulk-
                                                             Power System-Primary Frequency Response.
E-3.....................  ER17-2536-000, ER17-2536-001....  Pacific Gas and Electric Company.
E-4.....................  EL16-71-000, ER17-179-000.......  Monongahela Power Company; Potomac Edison Company;
                                                             West Penn Power Company; AEP Indiana Michigan
                                                             Transmission Company, Inc.; AEP Kentucky
                                                             Transmission Company, Inc.; AEP Ohio Transmission
                                                             Company, Inc.; AEP West Virginia Transmission
                                                             Company, Inc.; Appalachian Power Company; Indiana
                                                             Michigan Power Company; Kentucky Power Company;
                                                             Kingsport Power Company; Ohio Power Company;
                                                             Wheeling Power Company; Commonwealth Edison
                                                             Company; Commonwealth Edison Company of Indiana,
                                                             Inc.; Dayton Power and Light Company; Virginia
                                                             Electric and Power Company; Public Service Electric
                                                             and Gas Company; PECO Energy Company; PPL Electric
                                                             Utilities Corporation; Baltimore Gas and Electric
                                                             Company; Jersey Central Power & Light Company;
                                                             Metropolitan Edison Company; Pennsylvania Electric
                                                             Company; Potomac Electric Power Company; Atlantic
                                                             City Electric Company; Delmarva Power & Light
                                                             Company; UGI Utilities Inc.; Allegheny Electric
                                                             Cooperative, Inc.; CED Rock Springs, LLC; Old
                                                             Dominion Electric Cooperative; Rockland Electric
                                                             Company; Duquesne Light Company; Neptune Regional
                                                             Transmission System, LLC; Trans-Allegheny
                                                             Interstate Line Company; Linden VFT, LLC; American
                                                             Transmission Systems, Incorporated; City of
                                                             Cleveland, Department of Public Utilities, Division
                                                             of Cleveland Public Power; Duke Energy Ohio, Inc.;
                                                             Duke Energy Kentucky, Inc.; City of Hamilton, Ohio;
                                                             Hudson Transmission Partners, LLC; East Kentucky
                                                             Power Cooperative, Inc.; City of Rochelle; ITC
                                                             Interconnection LLC; PJM Interconnection, L.L.C.
E-5.....................  ER17-706-001....................  GridLiance West Transco LLC.
E-6.....................  ER16-262-001....................  Uniper Global Commodities North America LLC.
E-7.....................  ER16-2186-000...................  Deseret Generation & Transmission Co-operative, Inc.
E-8.....................  ER18-465-000....................  Public Service Company of New Hampshire.
E-9.....................  ER18-164-000....................  Public Service Company of Colorado.
E-10....................  ER17-156-002....................  Midcontinent Independent System Operator, Inc.
E-11....................  ER13-102-009, ER13-102-010, ER13- New York Independent System Operator, Inc.
                           102-011.
E-12....................  ER15-2059-002, ER13-102-008,      New York Independent System Operator, Inc.
                           (Not Consolidated).
E-13....................  EC18-21-000.....................  Michigan Electric Transmission Company, LLC.
E-14....................  EL17-83-000.....................  Piedmont Municipal Power Agency v. Duke Energy
                                                             Carolinas, LLC.
E-15....................  EL18-50-000, QF17-581-001, QF17-  Franklin Energy Storage One, LLC; Franklin Energy
                           582-001, QF17-583-002, QF17-584-  Storage Two, LLC; Franklin Energy Storage Three,
                           001.                              LLC; Franklin Energy Storage Four, LLC.
----------------------------------------------------------------------------------------------------------------
                                                  Miscellaneous
----------------------------------------------------------------------------------------------------------------
M-1.....................  RM18-7-000......................  Withdrawal of Pleadings.
----------------------------------------------------------------------------------------------------------------
                                                       Gas
----------------------------------------------------------------------------------------------------------------
G-1.....................  OR18-2-000......................  Permian Express Terminal LLC and Permian Express
                                                             Partners LLC.
G-2.....................  RP18-354-000....................  Chesapeake Energy Marketing, L.L.C. and Territory
                                                             Resources LLC.
G-3.....................  RP15-1022-010, RP16-581-004,      Alliance Pipeline L.P.
                           (Consolidated),.
                          RP16-292-004, RP16-240-003, RP16-
                           986-001, RP16-1045-001, (Not
                           Consolidated).
----------------------------------------------------------------------------------------------------------------
                                                      Hydro
----------------------------------------------------------------------------------------------------------------
H-1.....................  P-5-103.........................  Confederated Salish and Kootenai Tribes Energy
                                                             Keepers, Incorporated.
H-2.....................  P-10808-058.....................  Boyce Hydro Power, LLC.
H-3.....................  P-10808-056.....................  Boyce Hydro Power, LLC.
H-4.....................  CD18-1-001......................  Carson Tahoe Energy, LLC.
----------------------------------------------------------------------------------------------------------------

                                                  Certificates
----------------------------------------------------------------------------------------------------------------
C-1.....................  CP08-454-000....................  LA Storage, LLC.
C-2.....................  CP17-257-000....................  WBI Energy Transmission, Inc.
C-3.....................  CP17-468-000....................  Texas Eastern Transmission, LP.
C-4.....................  CP17-46-000.....................  Southern Natural Gas Company, L.L.C.
C-5.....................  CP15-499-000, CP15-499-001, CP17- Texas Eastern Transmission, LP; Pomelo Connector,
                           26-000.                           LLC.
----------------------------------------------------------------------------------------------------------------

     Dated: February 8, 2018.
Kimberly D. Bose,
Secretary.
    A free webcast of this event is available through http://ferc.capitolconnection.org/. Anyone with internet access who desires to
view this event can do so by navigating to www.ferc.gov's Calendar of
Events and locating this event in the Calendar. The event will contain
a link to its webcast. The Capitol Connection provides technical
support for the free webcasts. It also offers access to this event via
television in the DC area and via phone bridge for a fee. If you have
any questions, visit http://ferc.capitolconnection.org/ or contact
Danelle Springer or David Reininger at<PHONE_NUMBER>.
    Immediately following the conclusion of the Commission Meeting, a
press briefing will be held in the Commission Meeting Room. Members of
the public may view this briefing in the designated overflow room. This
statement is intended to notify the public that the press briefings
that follow Commission meetings may now be viewed remotely at
Commission headquarters, but will not be telecast through the Capitol
Connection service.

[FR Doc. 2018-03013 Filed 2-9-18; 11:15 am]
BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 45 (Tuesday, March 8, 2016)]
[Notices]
[Pages 12096-12097]
[FR Doc No: 2016-05092]

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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: EC16-58-000.
    Applicants: ReEnergy Sterling CT Limited Partnership.
    Description: Response to Commission Staff's request for
supplemental information of ReEnergy Sterling CT Limited Partnership.
    Filed Date: 2/25/16.
    Accession Number: 20160225-5100.
    Comments Due: 5 p.m. ET 3/07/16.

    Docket Numbers: EC16-84-000.
    Applicants: Kingbird Solar A, LLC, Kingbird Solar B, LLC.
    Description: Application for Authorization Under Section 203 of the
Federal Power Act and Request for Expedited Action, Confidential
Treatment, and Waivers of Kingbird Solar A, LLC, et al.
    Filed Date: 3/1/16.
    Accession Number: 20160301-5443.
    Comments Due: 5 p.m. ET 3/22/16.

    Docket Numbers: EC16-85-000.
    Applicants: Comanche Solar PV, LLC.
    Description: Application for Authorization Under Section 203 of the
Federal Power Act and Request for Waivers, Expedited Action, Shortened
Comment Period, and Confidential Treatment of Comanche Solar PV, LLC.
    Filed Date: 3/1/16.
    Accession Number: 20160301-5514.
    Comments Due: 5 p.m. ET 3/22/16.

    Take notice that the Commission received the following electric
rate filings:
    Docket Numbers: ER13-1937-003.
    Applicants: Southwest Power Pool, Inc.
    Description: Compliance filing: Order No. 1000 Interregional SPP-
MISO JOA Third Compliance Filing to be effective 3/30/2014.
    Filed Date: 3/1/16.
    Accession Number: 20160301-5222.
    Comments Due: 5 p.m. ET 3/22/16.

    Docket Numbers: ER13-1938-002.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Compliance filing: 2016-03-01_MISO-SPP Order 1000
Compliance (2/2/2016 Order) to be effective 3/30/2014.
    Filed Date: 3/1/16.
    Accession Number: 20160301-5336.
    Comments Due: 5 p.m. ET 3/22/16.

    Docket Numbers: ER14-154-004; ER14-153-004; ER10-3143-016; ER10-
2742-007.
    Applicants: Gibson City Energy Center, LLC, Grand Tower Energy
Center, LLC, Lakeswind Power Partners, LLC, Sabine Cogen, LP, Tilton
Energy LLC.
    Description: Second Amendment to June 26, 2015 Triennial Market-
Based Rate Update Filing for the Central Region of the Rockland
Sellers.
    Filed Date: 3/1/16.
    Accession Number: 20160301-5185.
    Comments Due: 5 p.m. ET 3/22/16.

    Docket Numbers: ER14-199-001.
    Applicants: Lakewood Cogeneration, L.P.
    Description: Compliance filing: Informational Filing of the
Essential Power Companies to be effective N/A.
    Filed Date: 3/1/16.
    Accession Number: 20160301-5401.
    Comments Due: 5 p.m. ET 3/22/16.

    Docket Numbers: ER14-714-001.
    Applicants: Essential Power Rock Springs, LLC.
    Description: Compliance filing: Information Filing of the Essential
Power Companies to be effective N/A.
    Filed Date: 3/1/16.
    Accession Number: 20160301-5403.
    Comments Due: 5 p.m. ET 3/22/16.

    Docket Numbers: ER14-715-001.
    Applicants: Essential Power OPP, LLC.
    Description: Compliance filing: Information Filing of the Essential
Power Companies to be effective N/A.
    Filed Date: 3/1/16.
    Accession Number: 20160301-5400.
    Comments Due: 5 p.m. ET 3/22/16.

    Docket Numbers: ER16-1051-000.
    Applicants: Graphic Packaging International, Inc.
    Description: Baseline eTariff Filing: Application for Initial
Market-Based Rate Tariff and Granting Certain Waivers to be effective
3/1/2016.
    Filed Date: 3/1/16.
    Accession Number: 20160301-5387.
    Comments Due: 5 p.m. ET 3/22/16.

    Docket Numbers: ER16-1052-000.
    Applicants: HollyFrontier El Dorado Refining LLC.
    Description: Tariff Cancellation: Notice of Cancellation of Market-
Based Rate Tariff to be effective 3/1/2016.
    Filed Date: 3/1/16.
    Accession Number: 20160301-5394.
    Comments Due: 5 p.m. ET 3/22/16.

    Docket Numbers: ER16-1053-000.
    Applicants: HollyFrontier El Dorado Refining LLC.
    Description: Compliance filing: Refiling of Baseline Market-Based
Rate Tariff to be effective 3/1/2016.
    Filed Date: 3/1/16.
    Accession Number: 20160301-5397.
    Comments Due: 5 p.m. ET 3/22/16.

    Docket Numbers: ER16-1054-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Sec.  205(d) Rate Filing: East Texas Cooperatives
Stated Rate to be effective 5/1/2016.
    Filed Date: 3/1/16.
    Accession Number: 20160301-5410.
    Comments Due: 5 p.m. ET 3/22/16.

    Docket Numbers: ER16-1055-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Original WMPA SA No. 4418,
Queue No. AA2-123 to be effective 2/17/2016.
    Filed Date: 3/2/16.
    Accession Number: 20160302-5053.
    Comments Due: 5 p.m. ET 3/23/16.

    Docket Numbers: ER16-1056-000.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Sec.  205(d) Rate Filing: 2016-03-02_SA 2899 ITC
Midwest-Northern States Power FCA (J278) to be effective 3/3/2016.
    Filed Date: 3/2/16.
    Accession Number: 20160302-5093.
    Comments Due: 5 p.m. ET 3/23/16.

    Docket Numbers: ER16-1057-000.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Compliance filing: 2016-03-02_SA 6507_White Pine 1 SSR
Settlement to be effective 6/1/2015.
    Filed Date: 3/2/16.
    Accession Number: 20160302-5099.
    Comments Due: 5 p.m. ET 3/23/16.

    Docket Numbers: ER16-1058-000.
    Applicants: Consumers Energy Company.
    Description: Sec.  205(d) Rate Filing: Amendment to Rate Schedule
No. 116 to be effective 5/1/2016.
    Filed Date: 3/2/16.
    Accession Number: 20160302-5149.
    Comments Due: 5 p.m. ET 3/23/16.

    Docket Numbers: ER16-1059-000.
    Applicants: Cleco Power LLC.
    Description: Sec.  205(d) Rate Filing: amendments to Cleco Power
Rate Schedule FERC No. 35 to be effective 3/3/2016.
    Filed Date: 3/2/16.
    Accession Number: 20160302-5152.
    Comments Due: 5 p.m. ET 3/23/16.

    Docket Numbers: ER16-1060-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Original Service Agreement
No. 4412; NQ-134 (ISA) to be effective 2/1/2016.
    Filed Date: 3/2/16.
    Accession Number: 20160302-5153.
    Comments Due: 5 p.m. ET 3/23/16.

    Docket Numbers: ER16-1061-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Sec.  205(d) Rate Filing: 1534R5 Kansas Municipal
Energy Agency NITSA NOA to be effective 2/1/2016.
    Filed Date: 3/2/16.
    Accession Number: 20160302-5155.
    Comments Due: 5 p.m. ET 3/23/16.

    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: March 2, 2016.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2016-05092 Filed 3-7-16; 8:45 am]
 BILLING CODE 6717-01-P