[Federal Register Volume 82, Number 66 (Friday, April 7, 2017)]
[Proposed Rules]
[Pages 16960-16962]
[FR Doc No: 2017-06750]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2016-9593; Airspace Docket No. 16-ACE-12]

Proposed Amendment of Class E Airspace; Falls City, NE

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: This action proposes to modify Class E airspace extending
upward from 700 feet above the surface at Brenner Field Airport, Falls
City, NE, due to the decommissioning of the Brenner non-directional
radio beacon (NDB) and cancellation of NDB approach. This action is
necessary to enhance the safety and management of standard instrument
approach procedures for instrument flight rules (IFR) operations at the
airport.

DATES: Comments must be received on or before May 22, 2017.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590; telephone
(202) 366-9826, or 1-800-647-5527. You must identify FAA Docket No.
FAA-2016-9593; Airspace Docket No. 16-ACE-12, at the beginning of your
comments. You may also submit comments through the Internet at http://www.regulations.gov. You may review the public docket containing the
proposal, any comments received, and any final disposition in person in
the Dockets Office between 9:00 a.m. and 5:00 p.m., Monday through
Friday, except Federal holidays.
    FAA Order 7400.11A, Airspace Designations and Reporting Points, and
subsequent amendments can be viewed online at http://www.faa.gov/air_traffic/publications/. For further information, you can contact the
Airspace Policy Group, Federal Aviation Administration, 800
Independence Avenue SW., Washington, DC 20591; telephone:<PHONE_NUMBER>.
The Order is also available for inspection at the National Archives and
Records Administration (NARA). For information on the availability of
FAA Order 7400.11A at NARA, call<PHONE_NUMBER>, or go to http://www.archives.gov/federal_register/code_of_federal-regulations/ibr_locations.html.
    FAA Order 7400.11A, Airspace Designations and Reporting Points, is

published yearly and effective on September 15.

FOR FURTHER INFORMATION CONTACT: Ruben Licon, Federal Aviation
Administration, Contract Support, Operations Support Group, Central
Service Center, 10101 Hillwood Parkway, Fort Worth, TX 76177; telephone
(817) 222-5941.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it would amend controlled airspace at Brenner Field Airport, Falls
City, NE, due to the decommissioning of the Brenner NDB and
cancellation of NDB approach.

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments, as
they may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
Communications should identify both docket numbers and be submitted in
triplicate to the address listed above. Commenters wishing the FAA to
acknowledge receipt of their comments on this notice must submit with
those comments a self-addressed, stamped postcard on which the
following statement is made: ``Comments to Docket No. FAA-2016-9593/
Airspace Docket No. 16-ACE-12.'' The postcard will be date/time stamped
and returned to the commenter.
    All communications received before the specified closing date for
comments will be considered before taking action on the proposed rule.
The proposal contained in this notice may be changed in light of the
comments received. A report summarizing each substantive public contact
with FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability of NPRMs

    An electronic copy of this document may be downloaded through the
Internet at http://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's Web page at http://www.faa.gov/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received, and any final disposition in person in the Dockets
Office (see the ADDRESSES section for the address and phone number)
between 9:00 a.m. and 5:00 p.m., Monday through Friday, except federal
holidays. An informal docket may also be examined during normal
business hours at the Federal Aviation Administration, Air Traffic
Organization, Central Service Center, Operations Support Group, 10101
Hillwood Parkway, Fort Worth, TX 76177.

Availability and Summary of Documents Proposed for Incorporation by
Reference

    This document proposes to amend FAA Order 7400.11A, Airspace
Designations and Reporting Points, dated August 3, 2016, and effective
September 15, 2016. FAA Order 7400.11A is publicly available as listed
in the ADDRESSES section of this document. FAA Order 7400.11A lists
Class A, B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Proposal

    The FAA is proposing an amendment to Title 14 Code of Federal
Regulations (14 CFR) part 71 by modifying Class E airspace extending
upward from 700 feet or more above the surface at Brenner Field
Airport, Falls City, NE. The action proposes to modify the airspace
extending upward from 700 feet above the surface within a 6.5-mile
radius (increased from 6.4 miles and remove the airspace associated
with the decommissioned Brenner NDB.
    Airspace reconfiguration is necessary due to the decommissioning of
the NDB, and cancellation of NDB approaches, and would enhance the
safety and management of the standard instrument approach procedures
for IFR operations at the airport.
    Class E airspace designations are published in paragraph 6005 of
FAA Order 7400.11A, dated August 3, 2016, and effective September 15,
2016, which is incorporated by reference in 14 CFR 71.1. The Class E
airspace designations listed in this document will be published
subsequently in the Order.

Regulatory Notices and Analyses

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current, is
non-controversial and unlikely to result in adverse or negative
comments. It, therefore: (1) Is not a ``significant regulatory action''
under Executive Order 12866; (2) is not a ``significant rule'' under
DOT Regulatory Policies and Procedures (44 FR 11034; February 26,
1979); and (3) does not warrant preparation of a regulatory evaluation
as the anticipated impact is so minimal. Since this is a routine matter
that will only affect air traffic procedures and air navigation, it is
certified that this rule, when promulgated, would not have a
significant economic impact on a substantial number of small entities
under the criteria of the Regulatory Flexibility Act.

Environmental Review

    This proposal will be subject to an environmental analysis in
accordance with FAA Order 1050.1F, ``Environmental Impacts: Policies
and Procedures'' prior to any FAA final regulatory action.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    Accordingly, pursuant to the authority delegated to me, the Federal
Aviation Administration proposes to amend 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for 14 CFR Part 71 continues to read as
follows:

    Authority: 49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.11A,
Airspace Designations and Reporting Points, dated August 3, 2016, and
effective September 15, 2016, is amended as follows:

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth.

* * * * *

ACE NE E5 Falls City, NE [Amended]

Falls City, Brenner Field, NE
    (Lat. 40[deg]04'44'' N., long. 95[deg]35'31'' W.)

    That airspace extending upward from 700 feet above the surface
within a 6.5-mile radius of Brenner Field.

    Issued in Fort Worth, TX, on March 28, 2017.
Walter Tweedy,
 Acting Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2017-06750 Filed 4-6-17; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 81, Number 229 (Tuesday, November 29, 2016)]
[Rules and Regulations]
[Page 85873]
[FR Doc No: 2016-28607]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

[Docket No. FDA-2016-N-1896]

New Animal Drugs for Use in Animal Feed; Category Definitions;
Confirmation of Effective Date

AGENCY: Food and Drug Administration, HHS.

ACTION: Direct final rule; confirmation of effective date.

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SUMMARY: The Food and Drug Administration (FDA) is confirming the
effective date of December 1, 2016, for the final rule that appeared in
the Federal Register of August 24, 2016. The direct final rule amends
the animal drug regulations by revising the definitions of the two
categories of new animal drugs used in medicated feeds to base category
assignment only on approved uses in major animal species. This document
confirms the effective date of the direct final rule.

DATES: Effective date of final rule published in the Federal Register
of August 24, 2016 (81 FR 57796) confirmed: December 1, 2016.

FOR FURTHER INFORMATION CONTACT: David Edwards, Center for Veterinary
Medicine (HFV-220), Food and Drug Administration, 7519 Standish Pl.,
Rockville, MD 20855,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In the Federal Register of August 24, 2016
(81 FR 57796), FDA solicited comments concerning the direct final rule
for a 75-day period ending November 7, 2016. FDA stated that the
effective date of the direct final rule would be on December 1, 2016,
unless any significant adverse comment was submitted to FDA during the
comment period. FDA did not receive any significant adverse comments.

    Authority:  Therefore, under the animal drug provisions of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 354, 360b, 360ccc,
360ccc-1, and 371), and under authority delegated to the
Commissioner of Food and Drugs, 21 CFR part 558 is amended.
Accordingly, the amendments issued thereby are effective.

    Dated: November 22, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-28607 Filed 11-28-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 80, Number 148 (Monday, August 3, 2015)]
[Notices]
[Pages 45969-45970]
[FR Doc No: 2015-18964]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #2

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

    Docket Numbers: ER15-623-006.
    Applicants: PJM Interconnection, L.L.C.
    Description: Compliance filing: Second Compliance Filing per July
22, 2015 Order in Docket No. ER15-623 to be effective 7/22/2015.
    Filed Date: 7/28/15.
    Accession Number: 20150728-5167.
    Comments Due: 5 p.m. ET 8/18/15.

    Docket Numbers: ER15-2282-001.
    Applicants: Sierra Pacific Power Company.

    Description: Tariff Amendment: Volume No. 7 Market Based Rate
Tariff Amendment to be effective 9/26/2015.
    Filed Date: 7/28/15.
    Accession Number: 20150728-5116.
    Comments Due: 5 p.m. ET 8/18/15.

    Docket Numbers: ER15-2288-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Original WMPA Service
Agreement No. 4233; Queue No. AB1-005 to be effective 7/22/2015.
    Filed Date: 7/28/15.
    Accession Number: 20150728-5133.
    Comments Due: 5 p.m. ET 8/18/15.

    Docket Numbers: ER15-2289-000.
    Applicants: ISO New England Inc., Green Mountain Power Corporation.
    Description: Sec.  205(d) Rate Filing: ISO-NE and Green Mountain
Power Corp. Small Gen. Interconnection Agreement to be effective 6/22/
2015.
    Filed Date: 7/28/15.
    Accession Number: 20150728-5135.
    Comments Due: 5 p.m. ET 8/18/15.

    Docket Numbers: ER15-2290-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: 2nd Quarter 2015 Update to
OA/RAA Membership Lists to be effective 6/30/2015.
    Filed Date: 7/28/15.
    Accession Number: 20150728-5141.
    Comments Due: 5 p.m. ET 8/18/15.

    Docket Numbers: ER15-2291-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Sec.  205(d) Rate Filing: Harlan Municipal Utilities
Formula Rate to be effective 10/1/2015.
    Filed Date: 7/28/15.
    Accession Number: 20150728-5147.
    Comments Due: 5 p.m. ET 8/18/15.

    Docket Numbers: ER15-2292-000.
    Applicants: Idaho Power Company.
    Description: Application regarding transmission formula rate of
Idaho Power Company.
    Filed Date: 7/28/15.
    Accession Number: 20150728-5152.
    Comments Due: 5 p.m. ET 8/18/15.

    Docket Numbers: ER15-2293-000.
    Applicants: Fair Wind Power Partners, L.L.C.
    Description: Baseline eTariff Filing: Fair Wind Power Partners LLC
MBR Tariff Filing to be effective 9/27/2015.
    Filed Date: 7/28/15.
    Accession Number: 20150728-5179.
    Comments Due: 5 p.m. ET 8/18/15.

    Take notice that the Commission received the following land
acquisition reports:

    Docket Numbers: LA15-2-000.
    Applicants: AV Solar Ranch 1, LLC, Baltimore Gas and Electric
Company, Beebe 1B Renewable Energy, LLC, Beebe Renewable Energy, LLC,
Calvert Cliffs Nuclear Power Plant, LLC, Cassia Gulch Wind Park LLC,
CER Generation, LLC, Commonwealth Edison Company, Constellation Energy
Commodities Group Maine, LLC, Constellation Energy Services of New
York, Inc., Constellation Energy Services, Inc., Constellation Mystic
Power, LLC, Constellation NewEnergy, Inc., Constellation Power Source
Generation, LLC, Cow Branch Wind Power, L.L.C, Criterion Power
Parnters, LLC, Exelon Framingham, LLC, Exelon Generation Company, LLC,
Exelon New Boston, LLC, Exelon West Medway, LLC, Exelon Wind 4, LLC,
Exelon Wyman, LLC, Fourmile Wind Energy, LLC, Handsome Lake Energy,
LLC, Harvest WindFarm, LLC, Harvest II Windfarm, LLC, High Mesa Energy,
LLC, Michigan Wind 1, LLC, Michigan Wind 2, LLC, Nine Mile Point
Nuclear Station, LLC, PECO Energy Company, R.E. Ginna Nuclear Power
Plant, LLC, Shooting Star Wind Project, LLC, Tuana Springs Energy, LLC,
Wind Capital Holdings, LLC, Wildcat Wind, LLC, 2014 ESA Project
Company, LLC
    Description: Quarterly Land Acquisition Report of the Exelon MBR
Entities, 2014 ESA Project Company, LLC, and 2015 ESA Project Company,
LLC.
    Filed Date: 7/28/15.
    Accession Number: 20150728-5076.
    Comments Due: 5 p.m. ET 8/18/15.

    Docket Numbers: LA15-2-000.
    Applicants: Astoria Generating Company, L.P., Big Sandy Peaker
Plant, LLC, California Electric Marketing, LLC, Crete Energy Venture,
LLC, CSOLAR IV South, LLC, CSOLAR IV West, LLC, High Desert Power
Project LLC, Kiowa Power Partners, LLC, Lincoln Generating Facility,
LLC, New Covert Generating Company, LLC, New Mexico Electric Marketing,
LLC, Rolling Hills Generating, L.L.C., Tenaska Alabama Partners, L.P.,
Tenaska Alabama II Partners, L.P., Tenaska Frontier Partners, Ltd.,
Tenaska Gateway Partners, Ltd., Tenaska Georgia Partners, L.P., Tenaska
Power Management, LLC, Tenaska Power Services Co., Tenaska Virginia
Partners, L.P., Texas Electric Marketing, LLC, TPF Generation Holdings,
LLC, Wolf Hills Energy, LLC, Alabama Electric Marketing, LLC
    Description: Quarterly Land Acquisition Report of Alabama Electric
Marketing, LLC, L.P., et al.
    Filed Date: 7/28/15.
    Accession Number: 20150728-5150.
    Comments Due: 5 p.m. ET 8/18/15.

    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: July 28, 2015.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2015-18964 Filed 7-31-15; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 234 (Thursday, December 7, 2017)]
[Notices]
[Page 57767]
[FR Doc No: 2017-26327]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4344-DR; Docket ID FEMA-2017-0001]

California; Amendment No. 7 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the State of California (FEMA-4344-DR), dated October 10, 2017, and
related determinations.

DATES: This amendment was issued November 28, 2017.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the State of California is hereby amended to include permanent work
under the Public Assistance program for those areas determined to have
been adversely affected by the event declared a major disaster by the
President in his declaration of October 10, 2017.

    Butte, Lake, Mendocino, Napa, Orange, Sonoma, and Yuba Counties
(already designated for Individual Assistance and assistance for
debris removal and emergency protective measures [Categories A and
B], including direct federal assistance, under the Public Assistance
program).

The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households In
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050 Presidentially Declared Disaster
Assistance to Individuals and Households--Other Needs; 97.036,
Disaster Grants--Public Assistance (Presidentially Declared
Disasters); 97.039, Hazard Mitigation Grant.

Brock Long,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2017-26327 Filed 12-6-17; 8:45 am]
 BILLING CODE 9111-23-P


[Federal Register Volume 79, Number 2 (Friday, January 3, 2014)]
[Proposed Rules]
[Pages 378-379]
[FR Doc No: 2013-30872]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2013-0668; FRL-9902-73-Region 9]

Revisions to the California State Implementation Plan, Antelope
Valley Air Quality Management District, Mojave Desert Air Quality
Management District, Monterey Bay Unified Air Pollution Control
District, and South Coast Air Quality Management District

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection EPA is proposing to approve
revisions to the Antelope Valley Air Quality Management District,
Mojave Desert AQMD, Monterey Bay Unified Air Pollution Control
District, and South Coast AQMD portion of the California State
Implementation Plan (SIP). These revisions concern volatile organic
compound (VOC) emissions from architectural coatings, liquefied
petroleum gas transfer, and ignition of barbecue charcoal. We are
approving three local rules and rescinding one local rule that regulate
these emission sources under the Clean Air Act (CAA or the Act).

DATES: Any comments on this proposal must arrive by February 3, 2014.

ADDRESSES: Submit comments, identified by docket number EPA-R09-OAR-
2013-0668, by one of the following methods:
    1. Federal eRulemaking Portal: www.regulations.gov. Follow the on-
line instructions.
    2. Email<EMAIL_ADDRESS>    3. Mail or deliver: Andrew Steckel (Air-4), U.S. Environmental
Protection Agency Region IX, 75 Hawthorne Street, San Francisco, CA
94105-3901.
    Instructions: All comments will be included in the public docket
without change and may be made available online at www.regulations.gov,
including any personal information provided, unless the comment
includes Confidential Business Information (CBI) or other information
whose disclosure is restricted by statute. Information that you
consider CBI or otherwise protected should be clearly identified as
such and should not be submitted through www.regulations.gov or email.
www.regulations.gov is an ``anonymous access'' system, and EPA will not
know your identity or contact information unless you provide it in the
body of your comment. If you send email directly to EPA, your email
address will be automatically captured and included as part of the
public comment. If EPA cannot read your comment due to technical
difficulties and cannot contact you for clarification, EPA may not be
able to consider your comment. Electronic files should avoid the use of
special characters, any form of encryption, and be free of any defects
or viruses.
    Docket: Generally, documents in the docket for this action are
available electronically at www.regulations.gov and in hard copy at EPA
Region IX, 75 Hawthorne Street, San Francisco, California 94105-3901.
While all documents in the docket are listed at www.regulations.gov,
some information may be publicly available only at the hard copy
location (e.g., copyrighted material, large maps), and some may not be
publicly available in either location (e.g., CBI). To inspect the hard
copy materials, please schedule an appointment during normal business
hours with the contact listed in the FOR FURTHER INFORMATION CONTACT
section.

FOR FURTHER INFORMATION CONTACT: Nicole Law, EPA Region IX, (415) 947-
4126<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: This proposal addresses the following local

rules: Mojave Desert AQMD Rule 1113 Architectural Coatings, Monterey
Bay Unified APCD Rule 426 Architectural Coatings, Antelope Valley AQMD
Rule 1174 Control of Volatile Organic Compound Emissions from the
Ignition of Barbecue Charcoal, and South Coast AQMD Rule 1177 Liquefied
Petroleum Gas Transfer and Dispensing. In the Rules and Regulations
section of this Federal Register, we are approving three of these local
rules and rescinding one local rule in a direct final action without
prior proposal because we believe these SIP revisions are not
controversial. If we receive adverse comments, however, we will publish
a timely withdrawal of the direct final rule and address the comments
in subsequent action based on this proposed rule. Please note that if
we receive adverse comment on an amendment, paragraph, or section of
this rule and if that provision may be severed from the remainder of
the rule, we may adopt as final those provisions of the rule that are
not the subject of an adverse comment.
    We do not plan to open a second comment period, so anyone
interested in commenting should do so at this time. If we do not
receive adverse comments, no further activity is planned. For further
information, please see the direct final action.

    Dated: September 25, 2013.
Jared Blumenfeld,
Regional Administrator, Region IX.
[FR Doc. 2013-30872 Filed 1-2-14; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 87, Number 87 (Thursday, May 5, 2022)]
[Notices]
[Pages 26763-26764]
[FR Doc No: 2022-09608]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-D-0113]

Clinical Pharmacology Considerations for Human Radiolabeled Mass
Balance Studies; Draft 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 draft guidance for industry entitled ``Clinical
Pharmacology Considerations for Human Radiolabeled Mass Balance
Studies.'' This draft guidance describes the FDA's recommendations
regarding clinical pharmacology considerations for conducting human
radiolabeled mass balance studies, including deciding whether and when
to conduct the study, designing the study, and reporting results.

DATES: Submit either electronic or written comments on the draft
guidance by August 3, 2022 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-2022-D-0113 for ``Clinical Pharmacology Considerations for Human
Radiolabeled Mass Balance Studies.'' 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. 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: Anuradha Ramamoorthy, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20903,
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Clinical Pharmacology Considerations for Human Radiolabeled
Mass Balance Studies.'' A human radiolabeled mass balance study is the
single most direct method to obtain quantitative and comprehensive
information on the absorption, distribution, metabolism, and excretion
(ADME) of an investigational drug in the human body. The mass balance
study can provide information to determine the overall pathways of
metabolism and excretion of an investigational drug, identify
circulating metabolites, and determine the abundance of metabolites
relative to the parent or total drug-related exposure. This guidance
provides FDA's recommendations for clinical pharmacology considerations
in conducting human radiolabeled mass balance studies, including: (1)
Deciding whether and when to conduct the study, (2) designing the
study, and (3) reporting results.
    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 ``Clinical
Pharmacology Considerations for Human Radiolabeled Mass Balance
Studies.'' 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. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information for submission of investigational new drug applications
in 21 CFR part 312 have been approved under OMB control number 0910-
0014, and the collections of information for submission of new drug
applications in 21 CFR part 314 have been approved under OMB control
number 0910-0001.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: April 29, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-09608 Filed 5-4-22; 8:45 am]
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[Federal Register Volume 82, Number 214 (Tuesday, November 7, 2017)]
[Notices]
[Pages 51623-51624]
[FR Doc No: 2017-24151]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL18-26-000]

EDF Renewable Energy, Inc. v. Midcontinent Independent System
Operator, Inc.; Southwest Power Pool, Inc.; PJM Interconnection,
L.L.C.; Notice of Complaint

    Take notice that on October 30, 2017, pursuant to sections 206 and
306 of the Federal Power Act, 16 U.S.C. 824e and 825e and Rule 206 of
the Federal Energy Regulatory Commission's (Commission) Rules of
Practice and Procedure, 18 CFR 385.206 (2017), EDF Renewable Energy,
Inc. (Complainant) filed a formal complaint against Midcontinent
Independent System Operator, Inc., Southwest Power Pool, Inc., and PJM
Interconnection, L.L.C. (Respondents) alleging that Respondents'
current Affected System coordination procedures and practices are
unjust, unreasonable and unduly discriminatory, all as more fully
explained in the complaint.
    Complainant certifies that a copy of the Complaint was served on
the contacts for Respondents as listed on the Commission's list of
Corporate Officials.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. The Respondent's
answer and all interventions, or protests must be filed on or before
the comment date. The Respondent's answer, motions to intervene, and
protests must be served on the Complainants.
    The Commission encourages electronic submission of protests and

interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 5 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for electronic review in the
Commission's Public Reference Room in Washington, DC. There is an
``eSubscription'' link on the Web site that enables subscribers to
receive email notification when a document is added to a subscribed
docket(s). For assistance with any FERC Online service, please email
[email protected], or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern Time on November 20, 2017.

    Dated: November 1, 2017.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2017-24151 Filed 11-6-17; 8:45 am]
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[Federal Register Volume 82, Number 197 (Friday, October 13, 2017)]
[Notices]
[Pages 47752-47753]
[FR Doc No: 2017-22174]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-5953]

Orthopaedic and Rehabilitation Devices Panel of the Medical
Devices Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming
public advisory committee meeting of the Orthopaedic and Rehabilitation
Devices Panel of the Medical Devices Advisory Committee. The general
function of the committee is to provide advice and recommendations to
the Agency on FDA's regulatory issues. The meeting will be open to the
public.

DATES: The meeting will be held on December 12, 2017, from 8 a.m. to 6
p.m.

ADDRESSES: Hilton Washington DC North/Gaithersburg, salons A, B, C, and
D, 620 Perry Pkwy., Gaithersburg, MD 20877. The hotel's telephone
number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Sara J. Anderson, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. G616, Silver Spring, MD 20993-0002, 301-
796-7047<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 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: On December 12, 2017, the committee will discuss, make
recommendations, and vote on information regarding the premarket
approval application (PMA) for the Barricaid Anular Closure Device by
Intrinsic Therapeutics. The proposed Indication for Use, as stated in
the PMA, is as follows: The Barricaid is intended to be implanted
following a limited discectomy, to prevent reherniation and the
recurrence of pain or dysfunction. The Barricaid is indicated for
patients with radiculopathy (with or without back pain), a posterior or
posterolateral herniation, characterized by radiographic confirmation
of neural compression using magnetic resonance imaging, and a large
anular defect (e.g., between 4-6 mm tall and between 6-12 mm wide) post
discectomy, at one level between L4 and S1.
    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 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.
Written submissions may be made to the contact person on or before
December 1, 2017. 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 November 3, 2017. 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 9, 2017.
    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
disabilities. If you require accommodations due to a disability, please
contact AnnMarie Williams at<EMAIL_ADDRESS>or 301-796-
5966 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 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: October 6, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-22174 Filed 10-12-17; 8:45 am]
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[Federal Register Volume 84, Number 205 (Wednesday, October 23, 2019)]
[Notices]
[Page 56870]
[FR Doc No: 2019-23191]

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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meeting; Cancellation

FEDERAL REGISTER CITATION OF PREVIOUS ANNOUNCEMENT:  To Be Published.

PREVIOUSLY ANNOUNCED TIME AND DATE OF THE MEETING:  Wednesday, October
23, 2019 at 10:00 a.m.

CHANGES IN THE MEETING: The Open Meeting scheduled under the Government
in the Sunshine Act for Wednesday, October 23, 2019 at 10:00 a.m., has
been cancelled and is expected to be rescheduled for a date in November
2019.

CONTACT PERSON FOR MORE INFORMATION:  For further information; please
contact Vanessa A. Countryman from the Office of the Secretary at (202)
551-5400.

    Dated: October 18, 2019.
Eduardo A. Aleman,
Deputy Secretary.
[FR Doc. 2019-23191 Filed 10-21-19; 11:15 am]
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