[Federal Register Volume 80, Number 120 (Tuesday, June 23, 2015)]
[Rules and Regulations]
[Pages 35841-35842]
[FR Doc No: 2015-15388]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

[Docket No. FDA-2010-N-0155]
RIN 0910-AG95

Veterinary Feed Directive; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; correction.

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SUMMARY: The Food and Drug Administration (FDA) is correcting a final
rule entitled ``Veterinary Feed Directive'' that appeared in the
Federal Register of June 3, 2015 (80 FR 31708). The rule amended FDA's
animal drug regulations regarding veterinary feed directive (VFD)
drugs. The document published with typographical and formatting errors.
This document corrects those errors.

DATES: Effective: October 1, 2015.

FOR FURTHER INFORMATION CONTACT: Sharon Benz, Center for Veterinary
Medicine (HFV-220), Food and Drug Administration, 7519 Standish Pl.,
Rockville, MD 20855,<PHONE_NUMBER>, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In FR Doc. 2015-13393, appearing on page
31708 in the Federal Register of Wednesday, June 3, 2015, the following
corrections are made:

Sec.  558.6  [Corrected]

0
1. On page 31734, in the second column, in Sec.  558.6 Veterinary feed
directive drugs, in paragraph (b)(5), remove ``(b)(2)(vi),'' and add in
its place ``(b)(3)(vi),''.
0
2. On page 31734, in the third column, in Sec.  558.6 Veterinary feed
directive drugs, the introductory text of paragraph (c)
``Responsibilities of any person who distributes an animal feed
containing a VFD drug or a combination VFD drug:'' is corrected as a
paragraph heading to read ``Responsibilities of any person who
distributes an animal feed containing a VFD drug or a combination VFD
drug.''

    Dated: June 18, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-15388 Filed 6-22-15; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 85, Number 122 (Wednesday, June 24, 2020)]
[Proposed Rules]
[Pages 37808-37809]
[FR Doc No: 2020-13301]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 300

[EPA-HQ-SFUND-1983-0002; FRL-10010-66-Region 5]

National Oil and Hazardous Substances Pollution Contingency Plan;
National Priorities List: Partial Deletion of the Allied Chemical &
Ironton Coke Superfund Site

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule; notification of intent.

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SUMMARY: The Environmental Protection Agency (EPA) Region 5 is issuing
a Notice of Intent to Delete soil (land), lagoon, and sediment portions
of the Allied Chemical & Ironton Coke Superfund Site (Site) in Ironton,
Ohio, from the National Priorities List (NPL) and requests public
comments on this proposed action. The NPL, promulgated pursuant to
Section 105 of the Comprehensive Environmental Response, Compensation,
and Liability Act (CERCLA) of 1980, as amended, is an appendix of the
National Oil and Hazardous Substances Pollution Contingency Plan (NCP).
The EPA and the State of Ohio, through the Ohio Environmental
Protection Agency (OEPA), have determined that all appropriate response
actions identified for these Site media, other than operation and
maintenance, monitoring, and five-year reviews, have been completed.
However, this deletion does not preclude future actions under
Superfund.

DATES: Comments must be received by July 24, 2020.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
SFUND-1983-0002, by one of the following methods:
    https://www.regulations.gov. Follow the on-line instructions for
submitting comments. Once submitted, comments cannot be edited or
removed from Regulations.gov. EPA may publish any comment received to
its public docket. Do not submit electronically any information you
consider to be Confidential Business Information (CBI) or other
information whose disclosure is

restricted by statute. Multimedia submissions (audio, video, etc.) must
be accompanied by a written comment. The written comment is considered
the official comment and should include discussion of all points you
wish to make. EPA will generally not consider comments or comment
contents located outside of the primary submission (i.e., on the web,
cloud, or other file sharing system). For additional submission
methods, the full EPA public comment policy, information about CBI or
multimedia submissions, and general guidance on making effective
comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets.
    Email<EMAIL_ADDRESS>    Written comments submitted by mail are temporarily suspended and no
hand deliveries will be accepted. We encourage the public to submit
comments via email or at https://www.regulations.gov.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-SFUND-
1983-0002. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
https://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through https://www.regulations.gov or email. The https://www.regulations.gov website
is an ``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an email comment directly to EPA without
going through https://www.regulations.gov, your email address will be
automatically captured and included as part of the comment that is
placed in the public docket and made available on the internet. If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. 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: All documents in the docket are listed in the https://www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available electronically at
https://www.regulations.gov and at https://www.epa.gov/superfund/allied-chemical-ironton or you may contact the person identified in the
FOR FURTHER INFORMATION CONTACT section for additional availability
information.
    The EPA is temporarily suspending its Docket Center and Regional
Records Centers for public visitors to reduce the risk of transmitting
COVID-19. In addition, many site information repositories are closed
and information in these repositories, including the deletion docket,
has not been updated with hardcopy or electronic media. For further
information and updates on EPA Docket Center services, please visit us
online at https://www.epa.gov/dockets.
    The EPA continues to carefully and continuously monitor information
from the Centers for Disease Control and Prevention (CDC), local area
health departments, and our Federal partners so that we can respond
rapidly as conditions change regarding COVID-19.

FOR FURTHER INFORMATION CONTACT: Karen Cibulskis, NPL Deletions
Coordinator, U.S. Environmental Protection Agency Region 5, at (312)
886-1843 or via email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: This partial deletion pertains to the soil
(land) portion of the Goldcamp Disposal Area (Operable Unit 1, or OU1);
the soil (land) and lagoon portion of the Coke Plant/Lagoon Area (OU2),
except for the OU2 ROD Soils Area 2 located within the bermed area of
the East Tank Farm (see Figure 3 in the Docket); and all of the Tar
Plant area (OU3), which addresses contaminated soil and sediment at the
Tar Plant and in the adjacent Ohio River.
    The OU2 ROD Soils Area 2 located within the bermed area of the East
Tank Farm contains components of the groundwater treatment system and
will not be remediated until after the groundwater cleanup is complete.
    Therefore, the OU2 ROD Soils Area 2 is not being considered for
deletion as part of this action. The contaminated groundwater at the
Site, which is present below all three OUs but is being addressed as
part of the OU1 and OU2 cleanup remedies, is undergoing a long-term
cleanup and is also not being considered for deletion as part of this
action. The OU2 ROD Soils Area 2 and the groundwater portions of the
Allied Chemical Site (i.e., the groundwater portion of OU1 and OU2,
which includes the contaminated groundwater below OU3) will remain on
the NPL.
    In the ``Rules and Regulations'' section of today's Federal
Register, we are publishing a direct final Notice of Partial Deletion
of the Allied Chemical & Ironton Coke Superfund Site without prior
Notice of Intent for Partial Deletion because EPA views this as a
noncontroversial revision and anticipates no adverse comment. We have
explained our reasons for this deletion in the preamble to the direct
final Notice of Partial Deletion, and those reasons are incorporated
herein. If we receive no adverse comment(s) on this partial deletion
action, we will not take further action on this Notice of Intent for
Partial Deletion. If we receive adverse comment(s), we will withdraw
the direct final Notice of Partial Deletion, and it will not take
effect. We will, as appropriate, address all public comments in a
subsequent final Notice of Partial Deletion based on this Notice of
Intent for Partial Deletion. We will not institute a second comment
period on this Notice of Intent for Partial Deletion. Any parties
interested in commenting must do so at this time.
    For additional information, see the direct final Notice of Partial
Deletion which is located in the ``Rules and Regulations'' section of
this Federal Register.

List of Subjects in 40 CFR Part 300

    Environmental protection, Air pollution control, Chemicals,
Hazardous substances, Hazardous waste, Intergovernmental relations,
Penalties, Reporting and recordkeeping requirements, Superfund, Water
pollution control, Water supply.

    Authority: 33 U.S.C. 1251 et seq.; 42 U.S.C. 9601-9657; E.O.
13626, 77 FR 56749, 3 CFR, 2013 Comp., p. 306; E.O. 12777, 56 FR
54757, 3 CFR, 1991 Comp., p. 351; E.O. 12580, 52 FR 2923, 3 CFR,
1987 Comp., p. 193.

    Dated: June 11, 2020.
Kurt Thiede,
Regional Administrator, Region 5.
[FR Doc. 2020-13301 Filed 6-23-20; 8:45 am]
BILLING CODE 6560-50-P


                             JON M. HUNTSMAN, JR.
Governor

                                 GARY HERBERT
Lieutenant Governor
                             JON M. HUNTSMAN, JR.
Governor

                                 GARY HERBERT
Lieutenant Governor
                                State of Utah

                      Department of Environmental Quality

                           Dianne R. Nielson, Ph.D.
Executive Director

                            DIVISION OF AIR QUALITY
                               Richard W. Sprott
Director

                                State of Utah

                      Department of Environmental Quality

                           Dianne R. Nielson, Ph.D.
Executive Director

                            DIVISION OF AIR QUALITY
                               Richard W. Sprott
Director

150 North 1950 West  ::  PO Box 144820  ::  Salt Lake City, UT 84114-4820 :: phone<PHONE_NUMBER> :: fax<PHONE_NUMBER>
T.D.D.<PHONE_NUMBER> ::  www.deq.utah.gov

                                                                    DAQE-040-05

July 5, 2017

Summit Vineyard, LLC
C/O PEC, Suite 109
6682 W. Greenfield Ave
West Allis, WI 53214

Re: Emission Credit Order

This Order removes the amount of emission credits listed below from Geneva Steel, and confirms their transfer to Summit Vineyard, LLC.  This transaction will be noted in the Emissions Credit Registry.

                                   Pollutant
                               Previous Credits
                                  (tons/year)
                       Credits transferred by this Order
                                  (tons/year)
                            Total Emission Credits
                                  (tons/year)
                                 PM10 Actuals
                                      0.0
                                     162.0
                                     162.0
                                  SO2 Actuals
                                      0.0
                                     37.0
                                     37.0
                                  NOx Actuals
                                      0.0
                                     188.0
                                     188.0

A summary of the updated Emissions Credit Registry for Utah County is enclosed. Please feel free to call John D. Jenks at<PHONE_NUMBER> if you have any questions.

Sincerely,

Richard W. Sprott, Executive Secretary
Utah Air Quality Board

RWS:JJ:jc

Enclosure


[Federal Register Volume 79, Number 164 (Monday, August 25, 2014)]
[Notices]
[Pages 50735-50736]
[FR Doc No: 2014-20037]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2014-0076; Notice 1]

Chrysler Group, LLC, Receipt of Petition for Decision of
Inconsequential Noncompliance

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation (DOT).

ACTION: Receipt of Petition.

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SUMMARY: Chrysler Group, LLC (Chrysler), a wholly owned subsidiary of
Fiat S.p.A., has determined that certain model year (MY) 2014 RAM 2500
trucks do not fully comply with paragraph S4.3 of Federal Motor Vehicle
Safety Standard (FMVSS) No. 110, Tire Selection and Rims and Motor
Home/Recreation Vehicle Trailer Load Carrying Capacity Information for
Motor Vehicles with a GVWR of 4,536 kilograms (10,000 pounds) or less,
and certain MY 2014 RAM 3500 trucks do not fully comply with paragraph
S5.3 of FMVSS No. 120, Tire Selection and Rims and Motor Home/
Recreation Vehicle Trailer Load Carrying Capacity Information for Motor
Vehicles with a GVWR of more than 4,536 kilograms (10,000 pounds).
Chrysler filed an appropriate report dated May 6, 2014, pursuant to 49
CFR part 573, Defect and Noncompliance Responsibility and Reports and
amended that report on June 10, 2014.

DATES: The closing date for comments on the petition is September 24,
2014.

ADDRESSES: Interested persons are invited to submit written data,
views, and arguments on this petition. Comments must refer to the
docket and notice number cited at the beginning of this notice and must
be submitted by any of the following methods:
     Mail: Send comments by mail addressed to: U.S. Department
of Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590.
     Hand Deliver: Deliver comments by hand to: U.S. Department
of Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590. The
Docket Section is open on weekdays from 10 a.m. to 5 p.m. except
Federal Holidays.
     Electronically: Submit comments electronically by: logging
onto the Federal Docket Management System (FDMS) Web site at http://www.regulations.gov/. Follow the online instructions for submitting
comments. Comments may also be faxed to<PHONE_NUMBER>.
    Comments must be written in the English language, and be no greater
than 15 pages in length, although there is no limit to the length of
necessary attachments to the comments. If comments are submitted in
hard copy form, please ensure that two copies are provided. If you wish
to receive confirmation that your comments were received, please
enclose a stamped, self-addressed postcard with the comments. Note that
all comments received will be posted without change to http://www.regulations.gov, including any personal information provided.
    Documents submitted to a docket may be viewed by anyone at the
address and times given above. The documents may also be viewed on the
Internet at http://www.regulations.gov by following the online
instructions for accessing the dockets. DOT's complete Privacy Act
Statement is available for review in the Federal Register published on
April 11, 2000, (65 FR 19477-78).
    The petition, supporting materials, and all comments received
before the close of business on the closing date indicated below will
be filed and will be considered. All comments and supporting materials
received after the closing date will also be filed and will be
considered to the extent possible. When the petition is granted or
denied, notice of the decision will be published in the Federal
Register pursuant to the authority indicated below.

SUPPLEMENTARY INFORMATION:
    I. Chrysler's Petition: Pursuant to 49 U.S.C. 30118(d) and 30120(h)
(see implementing rule at 49 CFR part 556), Chrysler submitted a
petition for an exemption from the notification and remedy requirements
of 49 U.S.C. Chapter 301 on the basis that this noncompliance is
inconsequential to motor vehicle safety.
    This notice of receipt of Chrysler's petition is published under 49
U.S.C. 30118 and 30120 and does not represent any agency decision or
other exercise of judgment concerning the merits of the petition.
    II. Vehicles Involved: The affected vehicles include approximately
198 MY 2014 RAM 2500 trucks and 87 MY 2014

RAM 3500 trucks that were produced from March 4, 2014 through March 6,
2014.
    III. Noncompliance: Chrysler explains that due to the absence of
the designated rim size and type on the 49 CFR part 567 certification
labels, the subject vehicles do not fully comply with paragraph S4.3 of
FMVSS No. 110 (RAM 2500 trucks) and paragraph S5.3 of FMVSS No. 120
(RAM 3500 trucks).
    IV. Rule Text: Paragraph S4.3 of FMVSS No. 110 requires in
pertinent part:

* * * S4.3.3 Additional labeling information for vehicles other than
passenger cars. Each vehicle shall show the size designation and, if
applicable, the type designation of rims (not necessarily those on
the vehicle) appropriate for the tire appropriate for use on that
vehicle, including the tire installed as original equipment on the
vehicle by the vehicle manufacturer, after each GAWR listed on the
certification label required by Sec.  567.4 or Sec.  567.5 of this
chapter. This information shall be in the English language, lettered
in block capitals and numerals not less than 2.4 millimeters high
and in the following format: * * *

    Paragraph S5.3 of FMVSS No. 120 requires in pertinent part:

* * * S5.3.1 Tires. The size designation (not necessarily for the
tires on the vehicle) and the recommended cold inflation pressure
for those tires such that the sum of the load ratings of the tires
on each axle (when the tires' load carrying capacity at the
specified pressure is reduced by diving by 1.10, in the case of a
tire subject to FMVSS No. 109) is appropriate for the GAWR as
calculated in accordance with S5.1.2.

S5.3.2 Rim. The size designation and, if applicable, the type
designation of Rims (not necessarily those on the vehicle)
appropriate for those tires. * * *

    V. Summary of Chrysler's Analyses: Chrysler stated its belief that
the subject noncompliance is inconsequential to motor vehicle safety
for the following reasons:
    1. Tire size and pressure information is located on the Tire
Inflation Pressure label which is located in the same door opening as
the certification label.
    a. Certification label is located on the driver door.
    b. Tire placard is located on the forward edge of the driver's B-
pillar.
    2. Tire size and inflation pressure can be found on each tire.
    3. Tire and rim information can be found in the vehicle owner's
manual.
    4. Rim/wheel size can be derived using the tire information printed
on the Tire Inflation Pressure label or the tire sidewall information.
    5. Chrysler is not aware of any warranty claims, field reports,
customer complaints, legal claims or any incidents or injuries related
to the subject condition.
    6. Chrysler also stated its belief that NHTSA has previously
granted petition similar in nature.
    Chrysler has additionally informed NHTSA that it has corrected the
noncompliance so that all future production of these vehicles will
fully comply with FMVSS Nos. 110 and 120.
    In summation, Chrysler believes that the described noncompliance of
the subject vehicles is inconsequential to motor vehicle safety, and
that its petition, to exempt from providing recall notification of
noncompliance as required by 49 U.S.C. 30118 and remedying the recall
noncompliance as required by 49 U.S.C. 30120 should be granted.
    NHTSA notes that the statutory provisions (49 U.S.C. 30118(d) and
30120(h)) that permit manufacturers to file petitions for a
determination of inconsequentiality allow NHTSA to exempt manufacturers
only from the duties found in sections 30118 and 30120, respectively,
to notify owners, purchasers, and dealers of a defect or noncompliance
and to remedy the defect or noncompliance. Therefore, any decision on
this petition only applies to the subject noncompliant vehicles that
Chrysler no longer controlled at the time it determined that the
noncompliance existed. However, any decision on this petition does not
relieve vehicle distributors and dealers of the prohibitions on the
sale, offer for sale, or introduction or delivery for introduction into
interstate commerce of the noncompliant vehicles under their control
after Chrysler notified them that the subject noncompliance existed.

    Authority:  (49 U.S.C. 30118, 30120: delegations of authority at
49 CFR 1.95 and 501.8)

Jeffrey Giuseppe,
Acting Director, Office of Vehicle Safety Compliance.
[FR Doc. 2014-20037 Filed 8-22-14; 8:45 am]
BILLING CODE 4910-59-P


[Federal Register Volume 81, Number 251 (Friday, December 30, 2016)]
[Proposed Rules]
[Pages 96404-96405]
[FR Doc No: 2016-31734]

=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. FDA-2016-D-2335]

Use of the Term ``Healthy'' in the Labeling of Human Food
Products; Request for Information and Comments; Extension of Comment
Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification; extension of comment period.

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SUMMARY: The Food and Drug Administration (FDA or we) is extending the
comment period for a docket to receive information and comments on the
use of the term ``healthy'' in the labeling of human food products. We
established the docket through a notice that appeared in the Federal
Register of September 28, 2016. In the notice, we requested comments on
the term ``healthy'', generally, and as a nutrient content claim in the
context of food labeling; we also requested comments on specific
questions contained in the notice. We are taking this action in
response to requests for an extension to allow interested persons
additional time to submit comments.

DATES: FDA is extending the comment period on the notice that published
in the Federal Register of September 28, 2016 (81 FR 66562). Submit
either electronic or written comments by April 26, 2017.

ADDRESSES: 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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, 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-2335 for ``Use of the Term 'Healthy' in the Labeling of
Human Food Products; Request for Information and Comments.'' 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 Division of Dockets Management 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.'' We will review
this copy, including the claimed confidential information, in our
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 Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Vincent de Jesus, Center for Food
Safety and Applied Nutrition (HFS-830), Food and Drug Administration,
5001 Campus Dr., College Park, MD 20740,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In the Federal Register of September 28,
2016, we published a notice announcing the establishment of a docket to
receive information and comments on the use of the term ``healthy'' in
the labeling of human food products. The notice discussed FDA's
position regarding the use of the term ``healthy'', the events that
prompted us to establish a docket to request information and comments
on this issue, and specific issues for consideration. We provided a
120-day comment period that was scheduled to end on January 26, 2017.
    We have received requests to extend the comment period. The
requests conveyed concern that the current 120-day comment period does
not allow sufficient time to develop meaningful or thoughtful comments
to the questions and issues we presented in the notice.
    We have considered the requests and are extending the comment
period for 90 days, until April 26, 2017. We believe that a 90-day
extension allows adequate time for interested persons to submit
comments.

    Dated: December 27, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-31734 Filed 12-29-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 80, Number 59 (Friday, March 27, 2015)]
[Rules and Regulations]
[Pages 16280-16281]
[FR Doc No: 2015-06949]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2015-0046]

Drawbridge Operation Regulations; Snake Creek, Islamorada, FL

AGENCY:  Coast Guard, DHS.

ACTION: Notice of temporary deviation from regulations; request for
comments.

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SUMMARY: The Coast Guard has issued a temporary deviation from the
operating schedule that governs the Snake Creek Bridge across Snake
Creek, at Islamorada, FL. This deviation will test a change to the
drawbridge operation schedule to determine whether a permanent change
to the schedule is needed. This deviation will allow Snake Creek Bridge
to open once an hour between 8 a.m. and 6 p.m. Local officials are
requesting this action to assist in reducing traffic caused by bridge
openings.

DATES: This deviation is effective without actual notice from March 27,
2015 to 6 p.m. on July 14, 2015. For the purposes of enforcement,
actual notice will be used from 8 a.m. on March 16, 2015, until March
27, 2015.
    Comments and related material must be received by the Coast Guard
on or before September 14, 2015. Requests for public meetings must be
received by the Coast Guard on or before July 14, 2015.

ADDRESSES: You may submit comments identified by docket number USCG-
2015-0046 using any one of the following methods:
    (1) Federal eRulemaking Portal: http://www.regulations.gov.
    (2) Fax:<PHONE_NUMBER>.
    (3) Mail or Delivery: Docket Management Facility (M-30), U.S.
Department of Transportation, West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue SE., Washington, DC 20590-0001. Deliveries
accepted between 9 a.m. and 5 p.m., Monday through Friday, except
federal holidays. The telephone number is<PHONE_NUMBER>.
    See the ``Public Participation and Request for Comments'' portion
of the SUPPLEMENTARY INFORMATION section below for instructions on
submitting comments. To avoid duplication, please use only one of these
three methods.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary deviation, call or email Coast Guard Sector Key West
Waterways Management Division; telephone<PHONE_NUMBER>, email<EMAIL_ADDRESS>If you have questions on viewing or
submitting material to the docket, call Cheryl Collins, Program
Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

A. Public Participation and Request for Comments

    We encourage you to participate in this rulemaking by submitting
comments and related materials. All comments received will be posted,
without change, to http://www.regulations.gov and will include any
personal information you have provided.

1. Submitting Comments

    If you submit a comment, please include the docket number for this
rulemaking (USCG-2015-0046), indicate the specific section of this
document to which each comment applies, and provide a reason for each
suggestion or recommendation. You may submit your comments and material
online (http://www.regulations.gov), or by fax, mail or hand delivery,
but please use only one of these means. If you submit a comment online
via http://www.regulations.gov, it will be considered received by the
Coast Guard when you successfully transmit the comment. If you fax,
hand deliver, or mail your comment, it will be considered as having
been received by

the Coast Guard when it is received at the Docket Management Facility.
We recommend that you include your name and a mailing address, an email
address, or a phone number in the body of your document so that we can
contact you if we have questions regarding your submission.
    To submit your comment online, type the docket number [USCG-2015-
0046] in the ``SEARCH'' box and click ``SEARCH.'' Click on ``Submit a
Comment'' on the line associated with this rulemaking. If you submit
your comments by mail or hand delivery, submit them in an unbound
format, no larger than 8\1/2\ by 11 inches, suitable for copying and
electronic filing. If you submit them by mail and would like to know
that they reached the Facility, please enclose a stamped, self-
addressed postcard or envelope. We will consider all comments and
material received during the comment period and may change the rule
based on your comments.

2. Viewing Comments and Documents

    To view comments, as well as documents mentioned in this preamble
as being available in the docket, go to http://www.regulations.gov,
type the docket number (USCG-2015-0046) in the ``SEARCH'' box and click
``SEARCH.'' Click on Open Docket Folder on the line associated with
this rulemaking. You may also visit the Docket Management Facility in
Room W12-140 on the ground floor of the Department of Transportation
West Building, 1200 New Jersey Avenue SE., Washington, DC 20590,
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays.

3. Privacy Act

    Anyone can search the electronic form of comments received into any
of our dockets by the name of the individual submitting the comment (or
signing the comment, if submitted on behalf of an association,
business, labor union, etc.). You may review a Privacy Act notice
regarding our public dockets in the January 17, 2008, issue of the
Federal Register (73 FR 3316).

4. Public Meeting

    As of now, we do not plan to hold a public meeting. You may submit
a request for one using one of the three methods specified under
ADDRESSES. Please explain why one would be beneficial. If we determine
that one would aid this rulemaking, we will hold one at a time and
place announced by a later notice in the Federal Register.

B. Basis and Purpose

    The Snake Creek Bridge in Islamorada, Florida, owned by the Florida
Department of Transportation, has a vertical clearance of 27 feet in
the closed position. The normal operating schedule as published in 33
CFR 117.331 is--``The draw of the Snake Creek bridge, at Islamorada,
Florida, shall open on signal, except that from 8 a.m. to 4 p.m., the
draw need open only on the hour and half-hour.'' This schedule has been
in effect since 2001.
    For the following reasons the Coast Guard is testing a new schedule
for the Snake Creek Bridge:
    1. As reported by village and city councils, vessel traffic has
negatively impacted Islamorada and surrounding communities. This
temporary deviation is intended to test a new bridge operation schedule
to reduce vehicular traffic caused by bridge openings during peak
travel times.
    2. On January 8-10, 2013, the Florida Department of Transportation
conducted a traffic monitoring study 1400 feet south of the Snake Creek
Bridge on US-1. The study found peak traffic volumes occurring at 08:45
a.m. and between 12:15 p.m. and 15:15 p.m.
    The types of vessels navigating Snake Creek include sport fishing
vessels and catamaran sailboats.
    This deviation is effective from 8 a.m. on March 16, 2015 until 6
p.m. on July 14, 2015. This deviation will allow the Snake Creek Bridge
in Islamorada, Florida to open on the top of the hour from 8 a.m. to 6
p.m.
    During the test deviation, vessels may signal the bridge to open on
the top of the hour from 8 a.m. to 6 p.m.
    Any vessel that can safely transit under the Snake Creek Bridge
while closed may continue to navigate under the bridge during this
deviation.
    As an alternate route, vessel operators may consider the use of
Channel Five, a navigable channel above Long Key, Florida 5.7 nautical
miles southwest of Snake Creek Bridge. The fixed US-1 bridge has a
vertical clearance of 65 feet.
    In accordance with 33 CFR 117.35(e), the drawbridge must return to
its regular operating schedule immediately at the end of this temporary
deviation's effective period. This deviation from the operating
regulations is authorized under 33 CFR 117.35.

    Dated: March 6, 2015.
Barry Dragon,
U.S. Coast Guard, Bridge Administrator, Seventh Coast Guard District.
[FR Doc. 2015-06949 Filed 3-26-15; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 85, Number 184 (Tuesday, September 22, 2020)]
[Rules and Regulations]
[Pages 59406-59409]
[FR Doc No: 2020-20826]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2020-0328; Product Identifier 2020-NM-030-AD; Amendment
39-21244; AD 2020-19-03]
RIN 2120-AA64

Airworthiness Directives; Airbus SAS Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The FAA is adopting a new airworthiness directive (AD) for
certain Airbus SAS Model A318 series airplanes; Model A319-111, -112, -
113,

-114, -115, -131, -132, and -133 airplanes; Model A320-211, -212, -214,
-216, -231, -232, and -233 airplanes; and Model A321-111, -112, -131, -
211, -212, -213, -231, and -232 airplanes. This AD was prompted by
reports of crack findings in and around the fastener holes of the
central and lateral window frame upper junction; those cracks were
found on fastener holes outside of the inspection area specified in a
certain airworthiness limitation item (ALI) task. This AD requires
repetitive inspections of the upper junction fastener holes at the
lateral window frame for cracking; and for certain airplanes,
repetitive inspections of the spotface around the fastener holes for
cracking; and corrective actions if necessary; as specified in a
European Union Aviation Safety Agency (EASA) AD, which is incorporated
by reference. The FAA is issuing this AD to address the unsafe
condition on these products.

DATES: This AD is effective October 27, 2020.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of October 27,
2020.

ADDRESSES: For the material incorporated by reference (IBR) in this AD,
contact the EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany;
telephone +49 221 8999 000; email<EMAIL_ADDRESS>internet
www.easa.europa.eu. You may find this IBR material on the EASA website
at https://ad.easa.europa.eu. You may view this IBR material at the
FAA, Airworthiness Products Section, Operational Safety Branch, 2200
South 216th St., Des Moines, WA. For information on the availability of
this material at the FAA, call<PHONE_NUMBER>. It is also available in
the AD docket on the internet at https://www.regulations.gov by
searching for and locating Docket No. FAA-2020-0328.

Examining the AD Docket

    You may examine the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2020-
0328; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this final rule, any comments received, and other information. The
address for Docket Operations is U.S. Department of Transportation,
Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200
New Jersey Avenue SE, Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Sanjay Ralhan, Aerospace Engineer,
Large Aircraft Section, International Validation Branch, FAA, 2200
South 216th St., Des Moines, WA 98198; telephone and fax<PHONE_NUMBER>;
email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    The EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD 2020-0019, dated February 5, 2020
(``EASA AD 2020-0019'') (also referred to as the Mandatory Continuing
Airworthiness Information, or ``the MCAI''), to correct an unsafe
condition for certain Airbus SAS Model A318-111, -112, -121, and -122
airplanes; Model A319-111, -112, -113, -114, -115, -131, -132, and -133
airplanes; Model A320-211, -212, -214, -215, -216, -231, -232, and -233
airplanes; and Model A321-111, -112, -131, -211, -212, -213, -231, and
-232 airplanes. Model A320-215 airplanes are not certificated by the
FAA and are not included on the U.S. type certificate data sheet;
therefore, this AD does not include those airplanes in the
applicability.
    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 by adding an AD that would apply to certain Airbus SAS
Model A318-111, -112, -121, and -122 airplanes; Model A319-111, -112, -
113, -114, -115, -131, -132, and -133 airplanes; Model A320-211, -212,
-214, -215, -216, -231, -232, and -233 airplanes; and Model A321-111, -
112, -131, -211, -212, -213, -231, and -232 airplanes. The NPRM
published in the Federal Register on April 10, 2020 (85 FR 20213). The
NPRM was prompted by reports of crack findings in and around the
fastener holes of the central and lateral window frame upper junction;
those cracks were found on fastener holes outside of the inspection
area specified in a certain ALI task. The NPRM proposed to require
repetitive inspections of the upper junction fastener holes at the
lateral window frame for cracking; and for certain airplanes,
repetitive inspections of the spotface around the fastener holes for
cracking; and corrective actions if necessary; as specified in an EASA
AD. The FAA is issuing this AD to address such cracking, which could
result in reduced structural integrity of the airplane. See the MCAI
for additional background information.

Comments

    The FAA gave the public the opportunity to participate in
developing this final rule. The following presents the comment received
on the NPRM and the FAA's response to each comment.

Request To Clarify Impact on Operator's Maintenance Program

    Delta Air Lines, Inc. (DAL) asked that the FAA include a statement
that the proposed AD affects and is related to AD 2019-23-01, Amendment
39-19794 (84 FR 66579, December 5, 2019) (``AD 2019-23-01''), and could
impact an operator's maintenance program. DAL stated that the
procedures specified in Airbus Service Bulletins A320-53-1448 and A320-
53-1449, both dated August 5, 2019 (referred to in EASA AD 2020-0019),
cancel and replace Airworthiness Limitation Item (ALI) Task 531125,
dated October 11, 2019, which is required in Airworthiness Limitations
Section (ALS) part 2, revision 7. DAL added that FAA Global Alternative
Method of Compliance (AMOC) AIR-676-20-138, dated April 4, 2020,
approved ALS part 2, revision 8, which removes ALI Task 531125. DAL
noted that, for operators that have incorporated revision 8 prior to
issuance of the proposed AD, there would be a potential gap in
tracking, and that adding the requested statement would bring awareness
to the relationship between the specified service information, MCAI,
affected ADs and ALI task.
    The FAA acknowledges the commenter's concern, and provides the
following clarification: AD 2019-23-01 does not mandate incorporation
of ALS part 2, revision 08, in the operator's maintenance or inspection
program. In addition, ALI Task 531125 was removed from ALS part 2,
revision 8, for specific model airplanes with specific configurations.
The FAA has no way to ascertain the impact on an individual operator's
maintenance program and customize the AD requirements in accordance
with DAL's maintenance or inspection program. However, under the
provisions of paragraph (i) of this AD, the FAA will consider requests
for approval of an AMOC if an operator's maintenance program is
adversely affected by the requirements of this AD, if sufficient data
are submitted to substantiate that fact and that show the method used
adequately addresses the unsafe condition identified in this AD. The
FAA has not changed this AD regarding this issue.

Conclusion

    The FAA reviewed the relevant data, considered the comment
received, and determined that air safety and the public interest
require adopting this final rule as proposed, except for minor

editorial changes. The FAA has determined that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM for addressing the unsafe condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM.

Related IBR Material Under 1 CFR Part 51

    EASA AD 2020-0019 describes procedures for repetitive inspections
of the upper junction fastener holes at the lateral window frame for
cracking, repetitive inspections of the spotface around the fastener
holes for cracking, and corrective actions. Corrective actions include
repair. This material is reasonably available because the interested
parties have access to it through their normal course of business or by
the means identified in the ADDRESSES section.

Costs of Compliance

    The FAA estimates that this AD affects 938 airplanes of U.S.
registry. The FAA estimates the following costs to comply with this AD:

                                      Estimated Costs for Required Actions
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per       Cost on U.S.
                          Labor cost                              Parts cost        product         operators
----------------------------------------------------------------------------------------------------------------
4 work-hours x $85 per hour = $340...........................              $0             $340         $318,920
----------------------------------------------------------------------------------------------------------------

    The FAA has received no definitive data that will enable the FAA to
provide cost estimates for the on-condition actions specified in this
AD.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. 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.
    The FAA is issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: General requirements.
Under that section, Congress charges the FAA with promoting safe flight
of civil aircraft in air commerce by prescribing regulations for
practices, methods, and procedures the Administrator finds necessary
for safety in air commerce. This regulation is within the scope of that
authority because it addresses an unsafe condition that is likely to
exist or develop on products identified in this rulemaking action.

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Will not affect intrastate aviation in Alaska, and
    (3) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

2020-19-03 Airbus SAS: Amendment 39-21244; Docket No. FAA-2020-0328;
Product Identifier 2020-NM-030-AD.

(a) Effective Date

    This AD is effective October 27, 2020.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to the Airbus SAS airplanes specified in
paragraphs (c)(1) through (4) of this AD, certificated in any
category, as identified in European Union Aviation Safety Agency
(EASA) AD 2020-0019, dated February 5, 2020 (``EASA AD 2020-0019'').
    (1) Model A318-111, -112, -121, and -122 airplanes.
    (2) Model A319-111, -112, -113, -114, -115, -131, -132, and -133
airplanes.
    (3) Model A320-211, -212, -214, -216, -231, -232, and -233
airplanes.
    (4) Model A321-111, -112, -131, -211, -212, -213, -231, and -232
airplanes.

(d) Subject

    Air Transport Association (ATA) of America Code 53, Fuselage.

(e) Reason

    This AD was prompted by reports of crack findings in and around
the fastener holes of the central and lateral window frame upper
junction; those cracks were found on fastener holes outside of the
inspection area specified in a certain airworthiness limitation item
(ALI) task. The FAA is issuing this AD to address such cracking,
which could result in reduced structural integrity of the airplane.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Requirements

    Except as specified in paragraph (h) of this AD: Comply with all
required actions and compliance times specified in, and in
accordance with, EASA AD 2020-0019.

(h) Exceptions to EASA AD 2020-0019

    (1) Where EASA AD 2020-0019 refers to its effective date, this
AD requires using the effective date of this AD.
    (2) The ``Remarks'' section of EASA AD 2020-0019 does not apply
to this AD.

(i) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
Large Aircraft Section, International Validation Branch, FAA, has
the authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the Large Aircraft Section, International Validation
Branch, send it to the attention of the person identified in
paragraph (j) of this AD. Information may be emailed to<EMAIL_ADDRESS>Before using any approved AMOC, notify your
appropriate principal inspector, or lacking a principal inspector,
the manager of the local flight

standards district office/certificate holding district office.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain instructions from a manufacturer, the instructions must be
accomplished using a method approved by the Manager, Large Aircraft
Section, International Validation Branch, FAA; or EASA; or Airbus
SAS's EASA Design Organization Approval (DOA). If approved by the
DOA, the approval must include the DOA-authorized signature.
    (3) Required for Compliance (RC): For any service information
referenced in EASA AD 2020-0019 that contains RC procedures and
tests: Except as required by paragraph (i)(2) of this AD, RC
procedures and tests must be done to comply with this AD; any
procedures or tests that are not identified as RC are recommended.
Those procedures and tests that are not identified as RC may be
deviated from using accepted methods in accordance with the
operator's maintenance or inspection program without obtaining
approval of an AMOC, provided the procedures and tests identified as
RC can be done and the airplane can be put back in an airworthy
condition. Any substitutions or changes to procedures or tests
identified as RC require approval of an AMOC.

(j) Related Information

    For more information about this AD, contact Sanjay Ralhan,
Aerospace Engineer, Large Aircraft Section, International Validation
Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone
and fax<PHONE_NUMBER>; email<EMAIL_ADDRESS>
(k) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (i) European Union Aviation Safety Agency (EASA) AD 2020-0019,
dated February 5, 2020.
    (ii) [Reserved]
    (3) For information about EASA AD 2020-0019, contact the EASA,
Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone +49 221
8999 000; email<EMAIL_ADDRESS>internet www.easa.europa.eu. You
may find this EASA AD on the EASA website at https://ad.easa.europa.eu.
    (4) You may view this material at the FAA, Airworthiness
Products Section, Operational Safety Branch, 2200 South 216th St.,
Des Moines, WA. For information on the availability of this material
at the FAA, call<PHONE_NUMBER>. This material may be found in the AD
docket on the internet at https://www.regulations.gov by searching
for and locating Docket No. FAA-2020-0328.
    (5) You may view this material that is incorporated by reference
at the National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, email
<EMAIL_ADDRESS>or go to: https://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on September 1, 2020.
Gaetano A. Sciortino,
Deputy Director for Strategic Initiatives, Compliance & Airworthiness
Division, Aircraft Certification Service.
[FR Doc. 2020-20826 Filed 9-21-20; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 83, Number 55 (Wednesday, March 21, 2018)]
[Notices]
[Pages 12371-12376]
[FR Doc No: 2018-05670]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RM18-12-000]

Inquiry Regarding the Effect of the Tax Cuts and Jobs Act on
Commission-Jurisdictional Rates

AGENCY: Federal Energy Regulatory Commission, Department of Energy.

ACTION: Notice of inquiry.

-----------------------------------------------------------------------

SUMMARY: The Federal Energy Regulatory Commission (Commission) is
seeking comment on the effect of the Tax Cuts and Jobs Act of 2017 on
Commission-jurisdictional rates. Of particular interest is whether, and
if so how, the Commission should address changes relating to
accumulated deferred income taxes and bonus depreciation.

DATES: Comments are due May 21, 2018.

ADDRESSES: Comments, identified by docket number, may be filed
electronically at http://www.ferc.gov in acceptable native applications
and print-to-PDF, but not in scanned or picture format. For those
unable to file electronically, comments may be filed by mail or hand-
delivery to: Federal Energy Regulatory Commission, Secretary of the
Commission, 888 First Street NE, Washington, DC 20426. The Comment
Procedures section of this document contains more detailed filing
procedures.

FOR FURTHER INFORMATION CONTACT:
Natalie Tingle-Stewart (Technical Information), Office of Energy Market
Regulation, 888 First Street NE, Washington, DC 20426,<PHONE_NUMBER>,
[email protected]
Kristen Fleet (Technical Information (Electric)), Office of Energy
Market Regulation, 888 First Street NE, Washington, DC 20426, (202)
502-8063, [email protected]
Monil Patel (Technical Information (Oil)), Office of Energy Market
Regulation, 888 First Street NE, Washington, DC 20426,<PHONE_NUMBER>,
[email protected]
James Sarikas (Technical Information (Natural Gas)), Office of Energy
Market Regulation, 888 First Street NE, Washington, DC 20426, (202)
502-6831, [email protected]
Steven Hunt (Accounting Information), Office of Enforcement, 888 First
Street NE, Washington, DC 20426,<PHONE_NUMBER>, [email protected]
Jonathan Taylor (Legal Information), Office of the General Counsel, 888
First Street NE, Washington, DC 20426,<PHONE_NUMBER>,
[email protected]

SUPPLEMENTARY INFORMATION:
    1. In this Notice of Inquiry (NOI), the Commission seeks comment on
the effect of the Tax Cuts and Jobs Act of 2017 (Tax Cuts and Jobs Act)
on Commission-jurisdictional rates. Of particular interest is whether,
and if so how, the Commission should address changes relating to
accumulated deferred income taxes (ADIT) and bonus depreciation.

I. Background

A. Tax Cuts and Jobs Act

    2. On December 22, 2017, the President signed into law the Tax Cuts
and Jobs Act,\1\ which provides a number of changes to the federal tax
system.\2\ One of the significant changes with widespread effects on
Commission-jurisdictional rates is the reduction of the federal
corporate income tax rate from a maximum 35 percent to a flat 21
percent rate, effective January 1, 2018.\3\ Because of the reduced
federal corporate income tax rate, the current balance of ADIT, that
is, the dollar amounts of taxes that public utilities, interstate
natural gas pipelines, and oil pipelines collected from customers in
anticipation of paying the Internal Revenue Service (IRS), does not
accurately reflect the current income tax liability. Additionally, the
Tax Cuts and Jobs Act prohibits the use of bonus depreciation for
assets acquired in the trade or business of the furnishing or sale of
electrical energy or transportation of natural gas by pipeline.
---------------------------------------------------------------------------

    \1\ Tax Cuts and Jobs Act, Public Law 115-97, 131 Stat. 2054
(2017).
    \2\ The Commission has previously addressed a major change in
the tax law when Congress passed the Tax Reform Act of 1986. See
Rate Changes Related to the Federal Corporate Income Tax Rate for
Public Utilities, Order No. 475, FERC Stats. & Regs. ] 30,752, order
on reh'g, 41 FERC ] 61,029 (1987).
    \3\ Section 13001 of the Tax Cuts and Jobs Act.
---------------------------------------------------------------------------

B. Requests for Commission Action

    3. In light of the Tax Cuts and Jobs Act, the Commission received
letters from several entities requesting that the Commission act to
ensure that the economic benefits related to the reduction in the
federal corporate income tax rate are passed through to customers.\4\
These entities request, among other things, that the Commission
investigate the continued justness and reasonableness of applicable
Commission-jurisdictional rates and explore ways to adjust the
transmission or transportation revenue requirements of Commission-
jurisdictional entities to prevent customers from overpaying for
service.
---------------------------------------------------------------------------

    \4\ These entities include State Advocates (States, state
agencies, and state consumer advocates), Organization of PJM States,
Inc., Organization of MISO States, American Public Gas Association,
Process Gas Consumers Group, Natural Gas Supply Association, Natural
Gas Indicated Shippers, Liquids Shippers Group, Oklahoma Attorney
General, Gordon Gooch (pro se consumer), Advanced Energy Buyers
Group, National Association of State Energy Officials, The R-Street
Institute, Office of the Ohio Consumers' Counsel, and the Governor
of Delaware. The Interstate Natural Gas Association of America,
Edison Electric Institute and the Industrial Energy Consumers of
America also sent letters to the Commission in reference to the
effects of the Tax Cuts and Jobs Act.
---------------------------------------------------------------------------

C. Commission's Actions

    4. Because the Tax Cuts and Jobs Act, among other things, reduces
the federal corporate income tax rate from a maximum 35 percent to a
flat 21 percent rate, beginning January 1, 2018, all public utilities,
interstate natural gas pipelines, and oil pipelines subject to the
federal corporate income tax will compute income taxes owed to the IRS
based on a 21 percent tax rate. Most Commission-jurisdictional electric
transmission and some non-transmission rates, most interstate natural
gas transportation rates, and some oil pipeline rates (and Form No. 6,
page 700) \5\ are based on cost of service, which comprises all
expenses incurred, including income taxes, plus a reasonable return on
capital.\6\ When the tax expense decreases, so does the cost of
service. The Commission must ensure that the rates, terms, and
conditions of jurisdictional services under the Federal Power Act
(FPA),\7\ the Natural Gas Act (NGA),\8\ and the Interstate Commerce Act
\9\ are just, reasonable, and not unduly discriminatory or
preferential.
---------------------------------------------------------------------------

    \5\ Most oil pipeline rates are indexed. However, these indexed
rates can be challenged on a cost-of-service basis and oil pipelines
can also file to set their rates on a cost-of-service basis. When
this document refers to cost-of-service ratemaking for oil
pipelines, it also refers to the reporting practices oil pipelines
use in the cost-of-service summary on Form No. 6, page 700.
    \6\ Pub. Sys. v. FERC, 709 F.2d 73, 75 (DC Cir. 1983).
    \7\ 16 U.S.C. 824d-e.
    \8\ 15 U.S.C. 717-717w (2012).
    \9\ 49 app. U.S.C. 1 et seq (1988).
---------------------------------------------------------------------------

    5. Because the federal corporate income tax rate has been reduced
to 21 percent, the electric transmission rates of entities with stated
rates or formula rates with fixed line items for the income tax rate
will not accurately reflect their cost of service. Similarly, the
transportation rates of interstate natural gas pipelines will not
accurately reflect their cost of service.
    6. As such, in order to provide more immediate relief to customers
of public utilities, pursuant to section 206 of the FPA,\10\ the
Commission is concurrently issuing orders to show cause directing
certain entities to propose revisions to the transmission rates in
their open access transmission tariffs or transmission owner tariffs to
reflect the change in the federal corporate income tax rate, or show
cause why they should not be required to do so.\11\
---------------------------------------------------------------------------

    \10\ 16 U.S.C. 824e.
    \11\ AEP Appalachian Transmission Company, Inc., 162 FERC ]
61,225 (2018); Alcoa Power Generating Inc.--Long Sault Division, 162
FERC ] 61,224 (2018).

---------------------------------------------------------------------------

    7. The Commission also is concurrently issuing a Notice of Proposed
Rulemaking (NOPR) \12\ regarding natural gas pipelines. In the NOPR,
the Commission proposes to require interstate natural gas pipelines to
make an informational filing with the Commission regarding the effect
on their revenue requirements of the (a) Tax Cuts and Jobs Act and (b)
the Revised Policy Statement on Treatment of Income Taxes.\13\ The
Revised Policy Statement establishes a policy that master limited
partnerships (MLP) are not permitted to recover an income tax allowance
in their cost of service. The NOPR proposes to collect financial
information to evaluate the impact of the Tax Cuts and Jobs Act and the
Revised Policy Statement on interstate natural gas pipelines' revenue
requirement, and to permit such pipelines to voluntarily file rate
reductions to reflect the decrease in the federal corporate income tax
pursuant to the Tax Cuts and Jobs Act or the elimination of the MLP tax
allowance, explain why no action is needed, or take no action other
than filing the informational filing.
---------------------------------------------------------------------------

    \12\ Interstate and Intrastate Natural Gas Pipelines; Rate
Changes Relating to Federal Income Tax Rate, 162 FERC ] 61,226
(2018).
    \13\ Inquiry Regarding the Commission's Policy for Recovery of
Income Tax Costs, 162 FERC ] 61,227 (2018) (Revised Policy
Statement).
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    8. Unlike public utilities and interstate natural gas pipelines,
the majority of oil pipelines set their rates using indexing, not cost-
of-service ratemaking using an oil pipeline's particular costs. Under
indexing, oil pipelines may adjust their rates annually, so long as
those rates remain at or below the applicable ceiling levels. The
ceiling levels change every July 1 based on an index that tracks
industry-wide cost changes.\14\ Under currently effective requirements
governing the schedule for indexing changes, the index will be re-
assessed in 2020 based upon industry-wide oil pipeline cost changes
between 2014 and 2019.\15\ While the Commission is not taking similar
industry-wide action regarding oil pipeline rates, when oil pipelines
file Form No. 6, page 700, they must report an income tax allowance and
cost of service consistent with the Revised Policy Statement \16\ and
the Tax Cuts and Jobs Act.
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    \14\ 18 CFR 342.3 (2017). Currently, the index level is based
upon the Producer's Price Index for Finished Goods plus 1.23.
    \15\ See, e.g., Five-Year Review of the Oil Pipeline Index, 153
FERC ] 61,312 (2015), aff'd, Assoc. of Oil Pipe Lines v. FERC, 876
F.3d 336 (DC Cir. 2017).
    \16\ See Revised Policy Statement, 162 FERC ] 61,227.
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II. Request for Comments

A. Accumulated Deferred Income Taxes

    9. ADIT balances are accumulated on the regulated books and records
of public utilities, interstate natural gas pipelines, and oil
pipelines based on the requirements of the Uniform System of Accounts.
ADIT arises from differences between the method of computing taxable
income for reporting to the IRS and the method of computing income for
regulatory accounting and ratemaking purposes.
    10. There are numerous items that are treated differently for IRS
purposes and regulatory accounting and ratemaking purposes, the most
familiar of which is depreciation expense. The following example uses
depreciation expense to illustrate the accumulation of ADIT balances.
    11. Under Commission ratemaking policies, income taxes included in
rates are determined based on the return on net rate base, with the
accumulated depreciation offset to rate base calculated using straight-
line depreciation.\17\ However, in calculating the amount of income
taxes due to the IRS, public utilities, interstate natural gas
pipelines, and oil pipelines generally are able to take advantage of
accelerated depreciation. Accelerated depreciation usually lowers
income taxes payable during the early years of an asset's life followed
by corresponding increases in income taxes payable during the later
years of an asset's life. This means that a public utility's,
interstate natural gas pipeline's, and oil pipeline's income taxes
payable to the IRS during any period differ from its income tax
allowance for ratemaking purposes during the same period. The
difference between the income taxes based on straight-line depreciation
and the actual income taxes paid by a public utility and interstate
natural gas pipeline generally are reflected in the Uniform System of
Accounts, Account 282 (Accumulated Deferred Income Taxes--Other
Property) \18\ and for oil pipelines in the Uniform System of Accounts,
Account 64 (Accumulated Deferred Income Tax Liabilities).\19\
---------------------------------------------------------------------------

    \17\ See, e.g., Pub. Serv. Co. of Colo., 155 FERC ] 61,028, at P
2 (2016); PJM Interconnection, L.L.C., 147 FERC ] 61,254 (2014),
order on compliance, 154 FERC ] 61,126, at P 2 (2016).
    \18\ See 18 CFR parts 101 and 201.
    \19\ See id. part 352.
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    12. Generally, ADIT liabilities are reductions to rate base, while
ADIT assets may be additions to rate base, depending on the nature of
the items that gave rise to the ADIT asset. In the example above,
because the resulting ADIT effectively provides the public utility,
interstate natural gas pipeline, and oil pipeline with cost-free
capital, the Commission subtracts the ADIT from the rate base of the
public utility, interstate natural gas pipeline, and oil pipeline,
thereby reducing customer charges. This method of passing the benefits
from accelerated depreciation on to customers throughout the asset's
life is referred to as tax normalization.\20\
---------------------------------------------------------------------------

    \20\ See Midcontinent Indep. Sys. Operator, Inc., 157 FERC ]
61,250, at P 2 (2016).
---------------------------------------------------------------------------

    13. As a result of the Tax Cuts and Jobs Act reducing the federal
corporate income tax rate from 35 percent to 21 percent, a portion of
an ADIT liability that was collected from customers will no longer be
due from public utilities, interstate natural gas pipelines, and oil
pipelines to the IRS and is considered excess ADIT, which must be
returned to customers in a cost-of-service ratemaking context. The
Commission expects that a similar effect would be reflected in the
cost-of-service summary in oil pipeline Form No. 6, page 700. For
public utilities, interstate natural gas pipelines, and oil pipelines
that have an ADIT asset, the Tax Cuts and Jobs Act will result in a
reduction to the ADIT asset, and public utilities, interstate natural
gas pipelines, and oil pipelines may seek to reflect in rates a portion
of such reductions. Public utilities, interstate natural gas pipelines,
and oil pipelines are required to adjust their ADIT assets and ADIT
liabilities for the effect of the change in tax rates in the period
that the change is enacted.\21\ That is, public utilities and
interstate natural gas pipelines are required to re-measure their ADIT
balances at the 21 percent rate and record a regulatory asset (Account
182.3) associated with deficient ADIT that is probable of future rate
recovery and/or a regulatory liability (Account 254) associated with
excess ADIT that is probable of future refund to customers.\22\ For oil
pipelines, the relevant accounts are Account 44 (Other Deferred
Charges) and Account 63 (Other Noncurrent Liabilities), respectively.
---------------------------------------------------------------------------

    \21\ See 18 CFR 35.24 and 154.305; see also Tax Normalization
for Certain Items Reflecting Timing Differences in the Recognition
of Expenses or Revenues for Ratemaking and Income Tax Purposes,
Order No. 144, FERC Stats. & Regs. ] 30,254 (1981), order on reh'g,
Order No. 144-A, FERC Stats. & Regs. ] 30,340 (1982).
    \22\ See Accounting for Income Taxes, Docket No. AI93-5-000, at
8 (1993).
---------------------------------------------------------------------------

1. Effect on Rate Base
    14. As a result of the federal corporate income tax rate change,
public utilities, interstate natural gas pipelines, and oil pipelines
will re-measure their ADIT

liabilities and assets, and establish regulatory liabilities and
assets, as appropriate. Public utilities' stated and formula rates and
interstate natural gas pipelines' stated rates may not include
comparable provisions allowing rate base to be reduced for regulatory
liabilities and increased for regulatory assets. Similar issues may
affect individual oil pipeline cost-of-service rate proceedings or the
summary cost of service filed by oil pipelines on Form No. 6, page 700.
Therefore, the Commission seeks comment on how to ensure that rate base
continues to be treated in a manner similar to that prior to the Tax
Cuts and Jobs Act (i.e., how to preserve rate base neutrality), until
excess and deficient ADIT have been fully settled in a just and
reasonable manner.
    15. The Commission seeks comment on whether, and if so how, public
utilities, interstate natural gas pipelines, and oil pipelines should
make adjustments so that rate base may be appropriately adjusted by
excess ADIT and deficient ADIT. Commenters should address whether
public utilities with formula rates could add a line item to their
adjustments to rate base such that rate base would be decreased by any
excess ADIT placed in Account 254 and increased by any deficient ADIT
placed in Account 182.3. With regard to stated rates, commenters should
address whether, and if so how, public utilities and interstate natural
gas pipelines could make adjustments to ensure that regulatory
liabilities and regulatory assets are treated comparably to the ADIT
liability and asset accounts. Oil pipelines should discuss how these
issues pertain to Form No. 6, page 700 reporting practices and, as
relevant, to cost-of-service ratemaking.
    16. Given that the Tax Cuts and Jobs Act took effect on January 1,
2018, there may be a lag in implementing any adjustments to rate base
to reflect excess and deficient ADIT. The Commission believes that it
may be appropriate for public utilities and interstate natural gas
pipelines to include interest on excess and deficient ADIT, for the
time period from January 1, 2018 until any adjustments to rate base are
implemented, and seeks comment on this topic.
2. Flow-Back or Recovery of Plant-Based ADIT
    17. Under the Tax Cuts and Jobs Act, public utilities and
interstate natural gas pipelines may flow back the excess ADIT
associated with utility plant assets (excess plant-based ADIT) no more
rapidly than over the life of the underlying assets.\23\ Specifically,
public utilities and interstate natural gas pipelines are generally not
permitted, in computing costs of service for ratemaking purposes and
reflecting operating results in their regulated books of account, to
flow-back excess plant-based ADIT more rapidly or greater than the
reductions permitted by the Average Rate Assumption Method, which
requires amortization of the excess tax reserve over the remaining
regulatory lives of the property that gave rise to the ADIT.
Alternatively, if the books and records of public utilities and
interstate pipelines do not contain the vintage data necessary to apply
the Average Rate Assumption Method, they are required to use an
alternative method, e.g., the Reverse South Georgia Method,\24\ to flow
back excess plant-based ADIT over the remaining regulatory life of the
property.\25\ The Commission seeks comment on how the Average Rate
Assumption Method, and alternatively, the Reverse South Georgia Method
or South Georgia Method, as appropriate, will be implemented and used
to adjust the tax allowance or expense included in cost-of-service
rates to reflect the amortization of excess and deficient plant-based
ADIT.
---------------------------------------------------------------------------

    \23\ Section 1561(d) of the Tax Cuts and Jobs Act.
    \24\ Under the South Georgia method, a calculation is taken of
the difference between the amount actually in the deferred account
and the amount that would have been in the account had normalization
continuously been followed. Any deficiency is collected from
ratepayers (i.e., South Georgia Method), and any excess is returned
to ratepayers (i.e., Reverse South Georgia Method), over the
remaining depreciable life of the plant that caused the difference.
Memphis Light, Gas and Water Div. v. FERC, 707 F.2d 565, 569 (DC
Cir. 1983).
    \25\ Section 1561(d) of the Tax Cuts and Jobs Act.
---------------------------------------------------------------------------

    18. While the Commission's understanding is that the Internal
Revenue Code does not apply the same standard to oil pipelines,\26\ the
amortization of excess plant-based ADIT also may affect oil pipeline
cost-of-service ratemaking. Accordingly, the Commission also seeks
comment on this issue as to oil pipelines.
---------------------------------------------------------------------------

    \26\ See id.; 26 U.S.C. 168(i)(9) & (10) (not including oil
pipelines among the list of public utilities subject to the
normalization requirement and the prohibition against flowing
through to ratepayers accelerated depreciation in cost-of-service
rates).
---------------------------------------------------------------------------

3. Flow-Back or Recovery of Non-Plant Based ADIT
    19. Because the normalization requirement under the Tax Cuts and
Jobs Act applies only to plant-based ADIT, the Commission seeks comment
on how quickly excess or deficient non-plant based ADIT should be
flowed back to or recovered from customers. Specifically, commenters
should address whether a regulatory asset or regulatory liability
recorded by a public utility or interstate natural gas pipeline
associated with non-plant based excess or deficient ADIT should be
amortized over a shorter (e.g., five-year) period. Oil pipeline
commenters should also address how quickly any excess non-plant based
ADIT should be flowed back in the data reported on Form No. 6, page 700
and in any cost-of-service proceeding as the issue arises.
4. Assets Sold or Retired After December 31, 2017
    20. Under the Commission's accounting requirements, when assets are
sold or retired, the original cost and accumulated depreciation of
those assets are removed from the books of a public utility, interstate
natural gas pipeline, or oil pipeline. Additionally, any associated
ADIT is concurrently removed from a public utility's, interstate
natural gas pipeline's, or oil pipeline's books because any previously
deferred tax effects related to the assets are now triggered as part of
the computation of gains or losses associated with the sale or
retirement (i.e., the deferred taxes are now payable to the IRS). The
excess ADIT resulting from the tax rate change of the Tax Cuts and Jobs
Act is also removed from the books. The Commission seeks comment on
whether, and if so how, it should address excess ADIT that is removed
from the books of public utilities, oil pipelines and interstate
natural gas pipelines after December 31, 2017, as a result of assets
being sold or retired.
5. Amortization of Excess and Deficient ADIT
    21. Commenters should address how public utilities with stated or
formula rates and interstate natural gas pipelines with stated rates
should adjust their income tax allowance such that the allowance would
be decreased or increased by the amortization of excess and deficient
ADIT. Likewise, commenters should address for oil pipelines how these
issues should be applied in cost-of-service ratemaking and in the cost-
of-service summary on Form No. 6, page 700.
    22. The Commission also seeks comment on whether a public utility
or interstate natural gas pipeline should record the amortization by
recording a reduction to the regulatory asset or regulatory liability
account and recording an offsetting entry to Account 407.3 (Regulatory
Debits) or Account 407.4 (Regulatory Credits). For oil pipelines, the
Commission seeks comment whether this information should be recorded in
Account 665

(Unusual or Infrequent Items (Debit)) or Account 645 (Unusual or
Infrequent Items (Credit)).
6. Supporting Worksheets
    23. The Commission seeks comment on whether it should require
public utilities, interstate natural gas pipelines, and oil pipelines
to provide to the Commission, on a one-time basis, additional
information, such as supporting worksheets, to show the computation of
excess or deficient ADIT and the corresponding flow-back of excess ADIT
to customers or recovery of deficient ADIT from customers. Commenters
should address what types of information public utilities, interstate
natural gas pipelines, and oil pipelines already record for ADIT-
related accounting and whether balances and amortization of regulatory
liability and asset accounts, computation of excess and deficient ADIT,
delineation between plant assets and non-plant assets, and a
description of the allocation method used to determine the
transmission-related portion of excess or deficient ADIT would be
appropriate to include in a supporting worksheet.
7. Treatment of ADIT for Partnerships
    24. In the Revised Policy Statement, the Commission determined that
MLPs will no longer be permitted to recover an income tax allowance.
Following the United Airlines decision,\27\ the Commission concluded
that MLP investors' tax costs were already reflected in the return on
equity, and thus, permitting an income tax allowance for MLPs would
lead to a double recovery of such tax costs. The Commission also stated
that other pass-through entities would need to address the double
recovery concern.
---------------------------------------------------------------------------

    \27\ United Airlines, Inc. v. FERC, 827 F.3d 122 (2016).
---------------------------------------------------------------------------

    25. The Commission seeks comment on the effect of the elimination
of the income tax allowance for MLPs on ADIT. Likewise, the Commission
seeks comment regarding the treatment of ADIT to the extent the income
tax allowance is eliminated for other non-MLP pass-through entities.
For such MLPs and pass-through entities, commenters should address
whether previously accumulated sums in ADIT should be eliminated
altogether from cost of service or whether those previously accumulated
sums should be placed in a regulatory liability account and returned to
ratepayers. Commenters should address specifically how their approach
would be applied in the MLP's or other pass-through entity's cost of
service.

B. Bonus Depreciation

    26. Generally, bonus depreciation is a tax incentive given to
companies to encourage certain types of investment. Bonus depreciation
allows companies to deduct a percentage of the cost of a qualified
property in the year the property is placed into service, in addition
to other depreciation deductions. That is, a company that purchases a
qualified business property and places it into service within a taxable
year can take a first year deduction in addition to any depreciation
deduction available.
    27. The Tax Cuts and Jobs Act increases the 50 percent bonus
depreciation allowance to 100 percent for qualified property placed in
service after September 1, 2017, and before January 1, 2023. Full bonus
depreciation is phased down by 20 percent each year for property placed
in service after December 31, 2022, and before January 1, 2027. Bonus
depreciation applies to new and used property, and must be acquired in
an arm's length transaction. It is not available for assets acquired in
the trade or business of the furnishing or sale of electrical energy,
water, or sewage disposal services; gas or steam through a local
distribution system; or transportation of gas or steam by pipeline.\28\
---------------------------------------------------------------------------

    \28\ Section 13301 of the Tax Cuts and Jobs Act.
---------------------------------------------------------------------------

    28. The Commission seeks comment on the effect of the bonus
depreciation change under the Tax Cuts and Jobs Act. The Commission
also seeks comment on whether, and if so how, the Commission should
take action to address bonus depreciation-related issues. Commenters
should address the practical application of their proposals, including,
among other things, what type of action the Commission should take and
whom the Commission should target with its action.

C. Additional Inquiries

    29. In addition, the Commission seeks comment on whether, and if so
how, it should take further action to address the change in the federal
corporate income tax rate. With respect to public utilities, the
Commission seeks comment on whether, in addition to the transmission
rates addressed in the orders to show cause being issued concurrently,
other jurisdictional transmission rates or non-transmission rates
should be revised to address the change in the federal income tax rate,
and identify the types of these other rates to the extent possible. The
Commission also seeks comment on effects of the Tax Cuts and Jobs Act
on Commission-jurisdictional rates of non-public utilities. Finally,
the Commission seeks comment on any other effects of the Tax Cuts and
Jobs Act, and whether, and if so how, the Commission should address
them.

III. Comment Procedures

    30. The Commission invites interested persons to submit comments on
the matters and issues proposed in this NOI, including any related
matters or alternative proposals that commenters may wish to discuss.
Comments are due May 21, 2018. Comments must refer to Docket No. RM18-
12-000, and must include the commenter's name, the organization they
represent, if applicable, and their address in their comments. To
facilitate the Commission's review of the comments, commenters are
requested to provide an executive summary of their position. Additional
issues the commenters wish to raise should be identified separately.
The commenters should double space their comments.
    31. The Commission encourages comments to be filed electronically
via the eFiling link on the Commission's website at http://www.ferc.gov. The Commission accepts most standard word processing
formats. Documents created electronically using word processing
software should be filed in native applications or print-to-PDF format
and not in a scanned format. Commenters filing electronically do not
need to make a paper filing.
    32. Commenters that are not able to file comments electronically
must send an original of their comments to: Federal Energy Regulatory
Commission, Secretary of the Commission, 888 First Street NE,
Washington, DC 20426.
    33. All comments will be placed in the Commission's public files
and may be viewed, printed, or downloaded remotely as described in the
Document Availability section below. Commenters on this proposal are
not required to serve copies of their comments on other commenters.

IV. Document Availability

    34. In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://www.ferc.gov) and
in the Commission's Public Reference Room during normal business hours
(8:30 a.m. to 5:00 p.m. Eastern time) at 888 First Street NE, Room 2A,
Washington, DC 20426.
    35. From the Commission's Home Page on the internet, this
information is available on eLibrary. The full text of

this document is available on eLibrary in PDF and Microsoft Word format
for viewing, printing, and/or downloading. To access this document in
eLibrary, type the docket number excluding the last three digits of
this document in the docket number field.
    36. User assistance is available for eLibrary and the Commission's
website during normal business hours from the Commission's Online
Support at<PHONE_NUMBER> (toll free at 1-866-208-3676) or email at
[email protected], or the Public Reference Room at (202) 502-
8371, TTY<PHONE_NUMBER>. Email the Public Reference Room at
[email protected].

    By direction of the Commission.

    Issued: March 15, 2018.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2018-05670 Filed 3-20-18; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 216 (Wednesday, November 9, 2022)]
[Notices]
[Pages 67701-67702]
[FR Doc No: 2022-24432]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-D-0697]

Sameness Evaluations in an Abbreviated New Drug Application--
Active Ingredients; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Sameness
Evaluations in an ANDA--Active Ingredients.'' This guidance is intended
to assist applicants preparing an abbreviated new drug application
(ANDA) by providing recommendations on demonstrating sameness between
the active ingredient in a proposed generic drug product and its
reference listed drug (RLD).

DATES: Submit either electronic or written comments on the draft
guidance by January 9, 2023 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-0697 for ``Sameness Evaluations in an ANDA--Active
Ingredients.'' 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: Susan Levine, Office of Generic Drugs,
Center for Drug Evaluation and Research, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 75, Rm. 1674, Silver Spring, MD 20993-
0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Sameness Evaluations in an ANDA--Active Ingredients.'' This
guidance is intended to assist applicants preparing an ANDA by
providing recommendations on demonstrating sameness between the active
ingredient in a proposed generic drug product and its RLD as required
under section 505(j)(2)(ii) of the Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 355(j)(2)(ii)) and FDA's regulations at 21 CFR
314.94(a)(3)(i).
    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) (Hatch-Waxman Amendments) created an approval pathway
for generic drug products under which applicants can submit an ANDA
under section 505(j) of the FD&C Act. An ANDA relies on the Agency's
previous finding of safety and effectiveness for an RLD and, as a
result, may be approved without submission of the same type and extent
of information that is required for approval of a new drug application
to establish the safety and effectiveness of the proposed product.
Among other things, an ANDA must contain information to show that the
active ingredient of the proposed generic drug product is the ``same
as'' that of the RLD (21 U.S.C. 355(j)(2)(A)(ii); 21 CFR 314.94(a)(5)).
FDA may not approve an ANDA unless the ANDA contains sufficient
information to show that, among other things, the active ingredient is
the same as that of the reference listed drug (21 CFR 314.127(a)(3)).
Accordingly, the ANDA applicant is responsible for providing sufficient
information to demonstrate that the proposed generic drug product is
the ``same as'' the RLD with respect to the active ingredient. To
assist prospective applicants in evaluating and demonstrating sameness,
this guidance provides information on active ingredient sameness
considerations.
    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 ``Sameness
Evaluations in an ANDA--Active Ingredients.'' 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 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 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: November 3, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-24432 Filed 11-8-22; 8:45 am]
BILLING CODE 4164-01-P