[Federal Register: August 6, 2010 (Volume 75, Number 151)]
[Notices]
[Page 47592-47594]
[DOCID:fr06au10-70]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2009-0255; FRL-8412-4]

Final Test Guideline; Product Performance of Skin-applied Insect
Repellents of Insect and Other Arthropods (OPPTS Test Guideline No.
810.3700); Notice of Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: EPA is announcing the availability of the final test guideline
for Product Performance of Skin-applied Insect Repellents of Insect and
Other Arthropods Test Guidelines (OPPTS Test Guideline No. 810.3700).

FOR FURTHER INFORMATION CONTACT: For general information contact:
Melissa Chun, Regulatory Coordination Staff (7101M), Office of Chemical
Safety and Pollution Prevention, Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(202) 564-1605; e-mail address<EMAIL_ADDRESS>    For technical information contact: Clara Fuentes, Biopesticides and
Pollution Prevention Division (7511P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; e-mail
address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Introduction

    This test guideline is part of a series of test guidelines
(referred to hereinafter as the harmonized test guidelines) established
by the Office of Chemical Safety and Pollution Prevention (OCSPP)
(formerly the Office of

Prevention, Pesticides and Toxic Substances (OPPTS) prior to April 22,
2010) for use in testing pesticides and chemical substances to develop
data for submission to the Agency under the Toxic Substances Control
Act (TSCA) (15 U.S.C. 2601 et seq.), the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA) (7 U.S.C. 136 et seq.), and
section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA) (21
U.S.C. 346a).
    The harmonized test guidelines serve as a compendium of accepted
scientific methodologies and protocols that are intended to provide
data to inform regulatory decisions under TSCA, FIFRA, and/or FFDCA.
The harmonized test guidelines provide guidance for conducting the
test, and are also used by EPA, the public, and the companies that are
subject to data submission requirements under TSCA, FIFRA, and/or the
FFDCA.
    As guidance documents, the harmonized test guidelines are not
binding on either EPA or any outside parties, and EPA may depart from
the harmonized test guidelines where circumstances warrant and without
prior notice. The procedures contained in the harmonized test
guidelines are recommended for generating the data that are the subject
of the harmonized test guidelines, but EPA recognizes that departures
may be appropriate in specific situations. You may propose alternatives
to the recommendations described in the harmonized test guidelines, and
the Agency will assess them for appropriateness on a case-by-case
basis.

II. General Information

A. Does this Action Apply to Me?

    This action is directed to the public in general. Although this
action may be of particular interest to those persons who are or may be
required to conduct testing of pesticides and chemical substances for
submission to EPA under TSCA, FIFRA, and/or FFDCA, the Agency has not
attempted to describe all the specific entities that may be affected by
this action. If you have any questions regarding the applicability of
this action to a particular entity, consult the technical person listed
under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Copies of this Document and Other Related Information?

    1. Docket for this document. EPA has established a docket for this
action under docket identification (ID) number EPA-HQ-OPP-2009-0255.
Publicly available docket materials are available either in the
electronic docket at http://www.regulations.gov, or, if only available
in hard copy, at the Office of Pesticide Programs (OPP) Regulatory
Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S.
Crystal Dr., Arlington, VA. The hours of operation of this Docket
Facility are from 8:30 a.m. to 4 p.m., Monday through Friday, excluding
legal holidays. The Docket Facility telephone number is<PHONE_NUMBER>.
    2. Electronic access to the harmonized test guidelines. To access
the harmonized test guidelines electronically, please go to http://
www.epa.gov/ocspp and select ``Test Methods and Guidelines.'' You may
also access the harmonized test guidelines in http://
www.regulations.gov grouped by series under docket ID numbers: EPA-HQ-
OPPT-2009-0150 through EPA-HQ-OPPT-2009-0159, and EPA-HQ-OPPT-2009-
0576.

III. Overview

A. What Action is EPA Taking?

    EPA is announcing the availability of a final harmonized test
guideline under OPPTS Series 810, entitled ``Product Performance of
Skin-applied Insect Repellents of Insects and Other Arthropods'' (OPPTS
Test Guideline No. 810.3700). The updated harmonized test guideline
recommends methods for conducting product performance testing of
topically applied repellents of insects and other arthropods. As a
guideline, it does not impose mandatory requirements. It does, however,
reflect the Agency's consideration of recommendations for steps
necessary to develop reliable data on performance of skin-applied
arthropod repellent products, and recommends procedures to follow when
human subjects are involved. The section of the existing 1999 draft
OPPTS Test Guideline No. 810.3700 applying to repellents for use in
outdoor premises will remain in effect.
    EPA will continue to consider refinements and new test methods as
they become available. In addition, the Agency will add recommended
test methods for other types of arthropod repellents such as those
impregnated into clothing or other fabrics or for repelling insect
pests in outdoor spaces. These additional guidelines will be published
for public comment at a later time.
    Studies conducted according to these harmonized test guidelines may
be used to address data requirements for pesticide registrations
defined at 40 CFR 158.400, 158.2070, and 158.2160. These harmonized
test guidelines may also be useful for satisfying FIFRA data
requirements for data call-ins issued under the authority of FIFRA
section 3(c)(2)(B).

B. How Were These Harmonized Test Guidelines Developed?

    The Agency has been working to revise this Product Performance Test
Guideline since it was published as a ``public draft'' in December
1999. EPA held a meeting of the FIFRA Scientific Advisory Panel (SAP)
on the revised draft guideline in April 2000. Revised drafts addressing
only repellents for topical application to human skin were presented to
the Human Studies Review Board (HRSB) in June 2006 and in October 2008.
The HSRB has reviewed and commented on numerous protocols for insect
repellent efficacy studies and reports of completed studies. Over the
course of these reviews the HSRB has made suggestions for further
strengthening the scientific and ethical conduct of this kind of
research; these have been incorporated into the updated harmonized test
guideline. A response-to-comments document has been placed in the
docket showing how the recommendations of the advisory committees have
been reflected in the harmonized test guideline.
    The Agency also convened a public meeting, that was announced in
the Federal Register of June 13, 2007 (72 FR 32647) (FRL-8135-9), of
national experts in which the revisions made in June 2006, were
discussed. The public meeting, ``Workshop for Sharing Technical
Information on Updated Methods for Testing Efficacy of Skin-Applied
Insect Repellents,'' involved leading scientists from the public and
private sectors who conduct this type of research.
    As a result of these various consultations and public comment
opportunities, EPA has revised its topical insect repellent efficacy
test guideline in response to the helpful suggestions from the various
scientific and ethics experts and comments received from the public.
    This updated harmonized test guideline contains new sections
addressing ethical considerations affecting the design and conduct of
repellent studies when human subjects are involved. Any research
conducted under this harmonized test guideline is covered by the
requirements of EPA's regulations for the protection of human subjects
of research set out at 40 CFR part 26, subparts K, L, and M. Persons
conducting and submitting topical repellent efficacy studies should
ensure compliance with all applicable requirements of that rule.

    EPA has also expanded and revised the sections dealing with
scientific aspects of this kind of study. This harmonized test
guideline provides specific recommendations for the design and
execution of studies to evaluate the performance of pesticide products
intended to repel insects and other arthropods in connection with the
products' registration under FIFRA. This harmonized test guideline
applies to products in any formulation--such as lotion, liquid, or
spray--intended to be applied directly to human skin. It does not apply
to products applied to or impregnated in clothing or fabric, or used to
repel insects from indoor or outdoor spaces. This harmonized test
guideline recommends appropriate study designs and methods for
selecting subjects, statistical analysis, and reporting.
    EPA recognizes that the World Health Organization (WHO) has also
published guidelines for testing efficacy of skin-applied mosquito
repellents. The purpose of the WHO guidelines is to provide procedures
and criteria for efficacy testing of mosquito repellents applied to
human skin. EPA's harmonized test guidelines coincide with the WHO
guidelines in providing guidance for laboratory and field tests. Both
guidelines recommend field testing, monitoring test sites, and
establishing criteria for acceptable landing pressure. EPA considered
the WHO guidelines during the development of its own guidelines.

List of Subjects

    Environmental protection, Chemical testing, Harmonized test
guidelines, Pesticides and pests.

    Dated: July 28, 2010.
Stephen A. Owens,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.

[FR Doc. 2010-19427 Filed 8-5-10; 8:45 am]
BILLING CODE 6560-50-S


[Federal Register: April 14, 2009 (Volume 74, Number 70)]
[Notices]
[Page 17270-17271]
[DOCID:fr14ap09-126]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-59716; File No. SR-NYSEArca-2009-11]

Self-Regulatory Organizations; NYSE Arca, Inc.; Order Approving a
Proposed Rule Change To Amend Rule 6.69--Reporting Duties

April 6, 2009.

I. Introduction

    On February 13, 2009, NYSE Arca, Inc. (``NYSE Arca'' or the
``Exchange''), filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change to amend Rule 6.69 to revise the procedures for
reporting open outcry trades that occur on the options trading floor.
The proposed rule change was published for comment in the Federal
Register on March 3, 2009.\3\ The Commission received no comment
letters on the proposal. This order approves the proposed rule change.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 59440 (February 24,
2009), 74 FR 9325 (``Notice'').
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II. Description

    NYSE Arca's proposal revises the procedures for reporting open
outcry trades that occur on the options trading floor. Under existing
NYSE Arca rules, all option transactions that occur on the options
trading floor must immediately be reported to the Exchange, in a form
and manner prescribed by the Exchange, for dissemination to the Options
Price Reporting Authority (``OPRA'').\4\ This requirement applies to
all OTP Holders who are required to report trades either directly to
OPRA or to another party who is responsible for reporting trades to
OPRA. Currently, pursuant to existing Rule 6.69(b), the responsible
party for reporting a transaction is the party that participates on the
transaction as the seller.
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    \4\ For transactions executed on the Exchange's electronic
trading platform, NYSE Arca will report the trade directly to OPRA.
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    The proposed rule change makes several clarifying changes to these
reporting obligations. First, the revised rule provides that whenever a
Floor Broker is participating on one side of a transaction, the Floor
Broker becomes the responsible party for reporting the trade,
regardless of whether the Floor Broker is the buyer or seller. Second,
in the event that there is a Floor Broker participating on both sides
of a transaction, the Floor Broker participating as the seller must
report the transaction to the Exchange. Third, for transactions
occurring on the Exchange between two Market Makers, the Market Maker
participating as the seller must report the transaction to the
Exchange.
    Finally, in order to further clarify the rules regarding reporting
duties, the Exchange proposes a new provision regarding Complex Orders.
Since each party to a Complex Order transaction (which involves the
simultaneous purchase and/or sale of two or more option series in the
same underlying security) could be both buying and selling different
series that make up an order, there may be no clearly defined seller,
as is required by the existing rule. Consequently, pursuant to the
proposed rule change, for Complex Order transactions between two Floor
Brokers or two Market Makers, the party responsible for reporting the
transaction will be the OTP Holder that first initiated the
transaction. This provision does not affect the obligation that a Floor
Broker has to report transactions pursuant to proposed Rule 6.69(b)(i),
but will have bearing when a Complex Order is executed between two
Floor Brokers or between two Market Makers.\5\
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    \5\ The proposal also eliminates Rule 6.69 Commentary .04, which
relates to an obsolete and outdated practice. ``Hard cards,'' which
refer to the cardboard backing of a paper trade ticket, are no
longer in use on the trading floor.
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    Presently, almost all orders on the Exchange are required to be in
electronic format prior to representation on the trading floor.\6\ The
Exchange represents that, typically, Floor Brokers enter the terms of
orders they receive into the Electronic Order Capture System (``EOC'')
\7\, and upon consummating a trade, the Floor Broker is able to
electronically report the transaction to the Exchange for processing
and dissemination to OPRA. In contrast, the Exchange notes that Market
Makers trading for their own proprietary account are not required to
electronically systematize their orders prior to responding to a call
from a Floor Broker. Consequently, a Market Maker acting as a
``seller'' (who would be the responsible reporting party under the
current rules) would be required to re-enter all the order information
already contained in the Floor Broker's EOC system and then send the
information to the Exchange for processing. The Exchange believes that
it will be more efficient for the Floor Broker to be the responsible
party for reporting a transaction. The Exchange further does not
believe that requiring a Floor Broker to report every transaction to
which they are a party will create any undue hardship or unnecessary
burden on the Floor Broker, given the existing requirement that orders
be put in electronic format prior to representation on the floor.
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    \6\ See Rule 6.67(c).
    \7\ The EOC system is the Exchange's electronic audit trail and
order tracking system that provides an accurate time-sequenced
record of all orders and transactions on the Exchange.
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III. Discussion and Commission's Findings

    After careful review, the Commission finds that the proposed rule
change is consistent with the requirements of the Act and the rules and
regulations thereunder applicable to a national securities exchange.\8\
In particular, the Commission finds that the proposed rule change is
consistent with Section 6(b)(5) of the Act,\9\ which requires, among
other things, that that the rules of a national securities exchange be
designed to promote just and equitable principles of trade, to remove

impediments to and perfect the mechanism of a free and open market and
a national market system and, in general, to protect investors and the
public interest, and not be designed to permit unfair discrimination
between customers, issuers, brokers, or dealers. The Commission
believes that the proposed rule change will increase efficiency in
trade reporting and remove potential confusion about which party to a
transaction is responsible for reporting such information.
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    \8\ In approving this proposal, the Commission has considered
the proposed rule's impact on efficiency, competition, and capital
formation. See 15 U.S.C. 78c(f).
    \9\ 15 U.S.C. 78f(b)(5).
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V. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\10\ that the proposed rule change (SR-NYSEArca-2009-11) be, and
hereby is, approved.
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    \10\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\11\
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    \11\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
[FR Doc. E9-8419 Filed 4-13-09; 8:45 am]

BILLING CODE 8010-01-P


Annex

Explanatory notes to the form for submission of information specified in
Annex E for use by the POPs Review Committee

In filling in the form please provide, where possible and relevant,
information of sufficient detail to inform scientific considerations of
the Committee in preparing the risk profile, emphasizing information on
study methods, tissue concentrations for comparative purposes, and
citations, including, if possible, original copies of papers not readily
available in the public literature. If the information is not
peer-reviewed, it may still be useful for the Committee.

Sources

Provide units for the data.

Historical data and trend data regarding production and uses.

Information regarding imports and exports.

Hazard assessment for the endpoints of concern

Only information regarding the most important endpoints of concern need
to be provided.

Data on human toxicity and ecotoxicity would be particularly helpful.

Environmental fate

Other information, including long-range environmental transport
modelling data.

Monitoring data

If possible, provide additional monitoring data with indication of the
data quality or the level of confidence.

Trend data.

Additional data related to the criteria in Annex D, especially where
relevant to persistence, bio-accumulation and long-range environmental
transport, as well as exposure. Please compare with the Annex D
evaluation by the Committee (http://www.pops.int/poprc/)

Environmental monitoring data and exposure data.

Exposure in local areas

Data regarding areas remote from sources of the chemical.

Data related to human health as well as wildlife.

Experimental or modelling data indicating possible long-range transport.

Occupational exposure data.

National and international risk evaluations etc.

Rationale (assessment information) for regulation on toxic chemicals.

National and international risk evaluations prepared by Governments,
inter-governmental organizations, regional economic integration
organizations and non-governmental organizations

Status of the chemical under international conventions

Only information regarding instruments other than the most well-known
ones should be submitted (see document UNEP/POPS/POPRC.1/INF/10).

Additional information may also be submitted that is relevant for the
evaluation of the chemical by the Committee but which does not fall
within the above categories.

__________________________

Secretariat of the Stockholm Convention on Persistent Organic Pollutants
page   PAGE  2

Secretariat of the Stockholm Convention on Persistent Organic Pollutants

Secretariat of the Stockholm Convention on Persistent Organic Pollutants


[Federal Register Volume 88, Number 4 (Friday, January 6, 2023)]
[Notices]
[Pages 1067-1069]
[FR Doc No: 2023-00058]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP23-35-000]

WBI Energy Transmission, Inc.; Notice of Request Under Blanket
Authorization and Establishing Intervention and Protest Deadline

    Take notice that on December 22, 2022, WBI Energy Transmission,
Inc. (WBI Energy), 1250 West Century Avenue, Bismarck, North Dakota
58503, filed in the above referenced docket, a prior notice request
pursuant to sections 157.205 and 157.208 of the Federal Energy
Regulatory Commission's (Commission) regulations under the Natural Gas
Act (NGA), and WBI Energy's blanket certificate issued in Docket No.
CP82-487-000, for authorization to construct and operate 15.3 miles of
natural gas lateral pipeline, a new receipt station and other
associated facilities in Dunn County, North Dakota, and to construct a
new interconnect \1\ with Big Horn Gas Gathering, LLC (Big Horn Gas)
and other associated facilities in Campbell and Sheridan Counties,
Wyoming in support of its Grassland South Expansion Project (Project).
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    \1\ WBI Energy acknowledges via a supplemental information
filing to their prior notice request that its new proposed
interconnect with Big Horn Gas in Sheridan County is referenced in
an Abbreviated Joint Application for a Certificate of Public
Conveniences and Necessity and Related Authorizations filed with the
Commission by Wyoming Interstate Company, LLC, Fort Union Gas
Gathering, LLC and Big Horn Gas, LLC on September 8, 2022 in Docket
No. CP22-508-000.
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    More specifically, the Project will provide 94,000 equivalent
dekatherms per day (Dth/day) of firm natural gas transmission capacity
from ONEOK Rockies Midstream, LLC's (ONEOK) Bear Creek natural gas
processing facility (Bear Creek Plant) in Dunn County, North Dakota to
a new interconnect with Big Horn Gas in Sheridan County, Wyoming. The
Project will include constructing approximately 15.3 miles of 12-inch-
diameter natural gas lateral pipeline from the Bear Creek Plant to WBI
Energy's existing Manning Compressor Station with one valve setting
midway between the two locations. WBI Energy will also construct a new
receipt station at the Bear Creek Plant, a new interconnect with Big
Horn Gas, and make other existing facility modifications, all as more
fully set forth in the request which is on file with the Commission and
open to public inspection.
    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) using
the ``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. At this time,
the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance, contact FERC at
[email protected] or call toll-free,<PHONE_NUMBER> or TTY,
(202) 502-8659.
    Any questions regarding this prior notice request should be
directed to Lori Myerchin, Director, Regulatory Affairs and
Transportation Services, WBI Energy Transmission, Inc., P.O. Box 5601,
Bismarck, North Dakota 58506, at<PHONE_NUMBER>3, or by email to
[email protected].
    Pursuant to section 157.9 of the Commission's Rules of Practice and

Procedure,\2\ within 90 days of this Notice the Commission staff will
either: complete its environmental review and place it into the
Commission's public record (eLibrary) for this proceeding; or issue a
Notice of Schedule for Environmental Review. If a Notice of Schedule
for Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission staff's issuance of
the final environmental impact statement (FEIS) or environmental
assessment (EA) for this proposal. The filing of an EA in the
Commission's public record for this proceeding or the issuance of a
Notice of Schedule for Environmental Review will serve to notify
Federal and State agencies of the timing for the completion of all
necessary reviews, and the subsequent need to complete all Federal
authorizations within 90 days of the date of issuance of the Commission
staff's FEIS or EA.
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    \2\ 18 CFR (Code of Federal Regulations) 157.9.
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Public Participation

    There are three ways to become involved in the Commission's review
of this project: you can file a protest to the project, you can file a
motion to intervene in the proceeding, and you can file comments on the
project. There is no fee or cost for filing protests, motions to
intervene, or comments. The deadline for filing protests, motions to
intervene, and comments is 5:00 p.m. Eastern Time on February 28, 2023.
How to file protests, motions to intervene, and comments is explained
below.

Protests

    Pursuant to section 157.205 of the Commission's regulations under
the NGA,\3\ any person \4\ or the Commission's staff may file a protest
to the request. If no protest is filed within the time allowed or if a
protest is filed and then withdrawn within 30 days after the allowed
time for filing a protest, the proposed activity shall be deemed to be
authorized effective the day after the time allowed for protest. If a
protest is filed and not withdrawn within 30 days after the time
allowed for filing a protest, the instant request for authorization
will be considered by the Commission.
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    \3\ 18 CFR 157.205.
    \4\ Persons include individuals, organizations, businesses,
municipalities, and other entities. 18 CFR 385.102(d).
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    Protests must comply with the requirements specified in section
157.205(e) of the Commission's regulations,\5\ and must be submitted by
the protest deadline, which is February 28, 2023. A protest may also
serve as a motion to intervene so long as the protestor states it also
seeks to be an intervenor.
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    \5\ 18 CFR 157.205(e).
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Interventions

    Any person has the option to file a motion to intervene in this
proceeding. Only intervenors have the right to request rehearing of
Commission orders issued in this proceeding and to subsequently
challenge the Commission's orders in the U.S. Circuit Courts of Appeal.
    To intervene, you must submit a motion to intervene to the
Commission in accordance with Rule 214 of the Commission's Rules of
Practice and Procedure \6\ and the regulations under the NGA \7\ by the
intervention deadline for the project, which is February 28, 2023. As
described further in Rule 214, your motion to intervene must state, to
the extent known, your position regarding the proceeding, as well as
your interest in the proceeding. For an individual, this could include
your status as a landowner, ratepayer, resident of an impacted
community, or recreationist. You do not need to have property directly
impacted by the project in order to intervene. For more information
about motions to intervene, refer to the FERC website at https://www.ferc.gov/resources/guides/how-to/intervene.asp.
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    \6\ 18 CFR 385.214.
    \7\ 18 CFR 157.10.
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    All timely, unopposed motions to intervene are automatically
granted by operation of Rule 214(c)(1). Motions to intervene that are
filed after the intervention deadline are untimely and may be denied.
Any late-filed motion to intervene must show good cause for being late
and must explain why the time limitation should be waived and provide
justification by reference to factors set forth in Rule 214(d) of the
Commission's Rules and Regulations. A person obtaining party status
will be placed on the service list maintained by the Secretary of the
Commission and will receive copies (paper or electronic) of all
documents filed by the applicant and by all other parties.

Comments

    Any person wishing to comment on the project may do so. The
Commission considers all comments received about the project in
determining the appropriate action to be taken. To ensure that your
comments are timely and properly recorded, please submit your comments
on or before February 28, 2023. The filing of a comment alone will not
serve to make the filer a party to the proceeding. To become a party,
you must intervene in the proceeding.

How To File Protests, Interventions, and Comments

    There are two ways to submit protests, motions to intervene, and
comments. In both instances, please reference the Project docket number
CP23-35-000 in your submission:
    (1) You may file your protest, motion to intervene, and comments by
using the Commission's eFiling feature, which is located on the
Commission's website (www.ferc.gov) under the link to Documents and
Filings. New eFiling users must first create an account by clicking on
``eRegister.'' You will be asked to select the type of filing you are
making; first select ``General'' and then select ``Protest'',
``Intervention'', or ``Comment on a Filing''; or \8\
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    \8\ Additionally, you may file your comments electronically by
using the eComment feature, which is located on the Commission's
website at www.ferc.gov under the link to Documents and Filings.
Using eComment is an easy method for interested persons to submit
brief, text-only comments on a project.
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    (2) You can file a paper copy of your submission by mailing it to
the address below. Your submission must reference the Project docket
number CP23-35-000.
    To mail via USPS, use the following address: Kimberly D. Bose,
Secretary, Federal Energy Regulatory Commission, 888 First Street NE,
Washington, DC 20426.
    To mail via any other courier, use the following address: Kimberly
D. Bose, Secretary, Federal Energy Regulatory Commission, 12225 Wilkins
Avenue, Rockville, Maryland 20852.
    The Commission encourages electronic filing of submissions (option
1 above) and has eFiling staff available to assist you at (202) 502-
8258 or [email protected]
    Protests and motions to intervene must be served on the applicant
either by mail at: Lori Myerchin, Director, Regulatory Affairs and
Transportation Services, WBI Energy Transmission, Inc., P.O. Box 5601,
Bismarck, North Dakota 58506, or email (with a link to the document)
at: [email protected]. Any subsequent submissions by an
intervenor must be served on the applicant and all other parties to the
proceeding. Contact information for parties can be downloaded from the
service list at the eService link on FERC Online.

Tracking the Proceeding

    Throughout the proceeding, additional information about the project
will be available from the Commission's

Office of External Affairs, at (866) 208-FERC, or on the FERC website
at www.ferc.gov using the ``eLibrary'' link as described above. The
eLibrary link also provides access to the texts of all formal documents
issued by the Commission, such as orders, notices, and rulemakings.
    In addition, the Commission offers a free service called
eSubscription which allows you to keep track of all formal issuances
and submittals in specific dockets. This can reduce the amount of time
you spend researching proceedings by automatically providing you with
notification of these filings, document summaries, and direct links to
the documents. For more information and to register, go to
www.ferc.gov/docs-filing/esubscription.asp.

    Dated: December 30, 2022.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2023-00058 Filed 1-5-23; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 88 (Monday, May 10, 2021)]
[Notices]
[Pages 24856-24857]
[FR Doc No: 2021-09828]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. CP15-554-009 and CP15-555-007]

Atlantic Coast Pipeline, LLC; Eastern Gas Transmission and
Storage, Inc. Notice of Intent To Prepare a Supplemental Environmental
Impact Statement and Notice of Schedule for Environmental Review for
the Proposed Atlantic Coast Pipeline Disposition and Restoration Plan
And Supply Header Project Restoration Plan

    The staff of the Federal Energy Regulatory Commission (FERC or
Commission) will prepare a supplemental environmental impact statement
(supplemental EIS) that will discuss the environmental impacts
resulting from Atlantic Coast Pipeline, LLC's (Atlantic) Atlantic Coast
Pipeline Disposition and Restoration Plan and Eastern Gas Transmission
and Storage, Inc.'s (EGTS) \1\ Supply Header Project Restoration
Plan.\2\ The Commission will use this supplemental EIS in its decision-
making process to determine whether Atlantic's and EGTS' proposals are
in the public interest.
---------------------------------------------------------------------------

    \1\ On November 1, 2020, Dominion Energy sold certain companies,
including Dominion Energy Transmission, Inc. (the Supply Header
Project developer), to Berkshire Hathaway Energy Company; and
Dominion Energy Transmission, Inc. changed its name to Eastern Gas
Transmission and Storage, Inc.
    \2\ The Atlantic Coast Pipeline Disposition and Restoration Plan
and the Supply Header Project Restoration Plan were submitted in
response to Commission staff's October 27, 2020 Data Request and can
be found on FERC's eLibrary at accession numbers 20210104-5278 and
20201120-5243.
---------------------------------------------------------------------------

    The National Environmental Policy Act (NEPA) requires the
Commission to take into account the environmental impacts that could
result from its action whenever it considers whether or not to
authorize a project or proposal. NEPA also requires the Commission to
discover concerns the public may have about proposed actions. This
process is referred to as ``scoping.'' The main goal of the scoping
process is to focus the analysis in the supplemental EIS on the
important environmental issues.
    On March 2, 2021, the Commission issued a Notice of Amendment of
Certificates and Opening of Scoping Period regarding the proposed
restoration activities associated with the Atlantic Coast Pipeline
(ACP) and Supply Header Project (SHP). That notice opened a public
scoping period of 45 days to gather input from the public and
interested agencies regarding both projects.

Summary of the Proposed Project Actions

    Atlantic requests authorization to implement its strategy for the
restoration of ACP project workspaces in compliance with associated
permits, authorizations, and legal agreements. For the pipeline,
Atlantic proposes to abandon in place all installed pipe (approximately
31.4 miles of the pipeline right-of-way) and restore lands that were
cleared and graded (approximately 82.7 miles of the pipeline right-of-
way), and seeks exemptions to the restoration of certain lands, to
include leaving felled trees in place in areas where trees have not yet
been cleared (approximately 25 miles of the pipeline right-of-way). For
ACP aboveground facilities, Atlantic proposes to restore the sites, and
manage the disposition of the materials and land through an investment
recovery process.
    EGTS requests authorization to implement its strategy for the
restoration of SHP workspaces in compliance with associated permits,
authorizations, and legal agreements. EGTS plans to leave in place all
previously installed pipe (approximately 11.7 miles) and complete final
restoration of approximately 9 miles of the pipeline right-of-way that
EGTS has previously cleared and/or graded. EGTS owns the properties on
which SHP aboveground facilities are located and proposes to stabilize
all facility sites and prepare assets for long term preservation.

The Supplemental EIS Process and Identified Issues

    The supplemental EIS will discuss impacts that could occur as a
result of the proposed activities related to the disposition of the
projects and restoration of the project workspaces. To date, we have
identified potential environmental concerns related to Atlantic's and
EGTS' proposals to leave felled trees in place and abandon installed
pipe, and potential impacts on wetlands and waterbodies from
restoration activities. As a result, the supplemental EIS will include
a reevaluation of mitigation associated with the restoration activities
previously analyzed for the construction of the ACP and SHP.\3\ The
supplemental EIS will also consider revisions to land use, air
emissions, and noise levels. Commission staff will also evaluate
reasonable alternatives to the proposed project amendments or portions
of the proposals and make recommendations on how to lessen or avoid
impacts on the various resource areas.
---------------------------------------------------------------------------

    \3\ Atlantic Coast Pipeline and Supply Header Project Final
Environmental Impact Statement, issued on July 21, 2017; accessible
on the FERC website at: https://cms.ferc.gov/final-environmental-impact-statement-atlantic-coast-pipeline-and-supply-header-project.
---------------------------------------------------------------------------

    The supplemental EIS will present Commission staff's independent
analysis of the issues. The draft supplemental EIS will be available in
electronic format in the public record through eLibrary \4\ and the
Commission's natural gas environmental documents web page (https://www.ferc.gov/industries-data/natural-gas/environment/environmental-documents). If

eSubscribed, you will receive instant email notification when the draft
supplemental EIS is issued. The draft supplemental EIS will be issued
for an allotted public comment period. After the comment period on the
draft supplemental EIS, Commission staff will consider all timely
comments and revise the document, as necessary, before issuing a final
supplemental EIS.
---------------------------------------------------------------------------

    \4\ For instructions on connecting to eLibrary, refer to the
last page of this notice.
---------------------------------------------------------------------------

    With this notice, the Commission is asking agencies with
jurisdiction by law and/or special expertise with respect to the
environmental issues of these projects to formally cooperate in the
preparation of the supplemental EIS.\5\ Agencies that would like to
request cooperating agency status should follow the instructions for
filing comments provided under the Public Participation section of this
notice. The U.S. Forest Service has already agreed to participate as a
cooperating agency in the preparation of the supplemental EIS.
---------------------------------------------------------------------------

    \5\ The Council on Environmental Quality regulations addressing
cooperating agency responsibilities are at Title 40, Code of Federal
Regulations, Part 1501.6.
---------------------------------------------------------------------------

Environmental Mailing List

    The environmental mailing list includes federal, state, and local
government representatives and agencies; elected officials;
environmental and public interest groups; Native American Tribes; other
interested parties; and local libraries and newspapers. This list also
includes all affected landowners (as defined in the Commission's
regulations) for the original ACP and SHP and anyone who submits
comments on the project amendments. Commission staff will update the
environmental mailing list as the analysis proceeds to ensure that
Commission notices related to this environmental review are sent to all
individuals, organizations, and government entities interested in and/
or potentially affected by the proposed project amendments.
    A Notice of Availability of the draft supplemental EIS will be sent
to the environmental mailing list and will provide instructions to
access the electronic document on the FERC's website (www.ferc.gov). If
you need to make changes to your name/address, or if you would like to
remove your name from the mailing list, please complete one of the
following steps:
    (1) Send an email to<EMAIL_ADDRESS>stating your
request. You must include the docket number CP15-554-009 and/or CP15-
555-007 in your request. If you are requesting a change to your
address, please be sure to include your name and the correct address.
If you are requesting to delete your address from the mailing list,
please include your name and address as it appeared on this notice.
This email address is unable to accept comments.
    OR
    (2) Return the attached ``Mailing List Update Form'' (appendix
1).\6\
---------------------------------------------------------------------------

    \6\ The appendices referenced in this notice will not appear in
the Federal Register. Copies of appendices were sent to all those
receiving this notice in the mail and are available at www.ferc.gov
using the link called ``eLibrary'' or from the Commission's Public
Reference Room, 888 First Street NE, Washington, DC 20426, or call
(202) 502-8371. For instructions on connecting to eLibrary, refer to
the last page of this notice.
---------------------------------------------------------------------------

Schedule for Environmental Review

    The Commission's March 2, 2021 Notice of Amendment for the ACP and
SHP alerted other agencies issuing federal authorizations of the
requirement to complete all necessary reviews and to reach a final
decision on the request for a federal authorization within 90 days of
the date of issuance of the Commission staff's final supplemental EIS
for the ACP and SHP. This instant notice identifies the FERC staff's
planned schedule for completion of the final supplemental EIS for the
ACP and SHP, which is based on an issuance of the draft supplemental
EIS in July 2021. The forecasted schedule for both the draft and final
supplemental EIS is based upon Atlantic and EGTS providing complete and
timely responses to any future data requests. In addition, the schedule
assumes that the cooperating agencies will provide input on their areas
of responsibility on a timely basis.

Issuance of Notice of Availability of the final supplemental EIS--
November 19, 2021
90-day Federal Authorization Decision Deadline--February 17, 2022

    If a schedule change becomes necessary for the final EIS, an
additional notice will be provided so that the relevant agencies are
kept informed of the Project's progress.

Additional Information

    In order to receive notification of the issuance of the EIS and to
keep track of all formal issuances and submittals in specific dockets,
the Commission offers a free service called eSubscription. This can
reduce the amount of time you spend researching proceedings by
automatically providing you with notification of these filings,
document summaries, and direct links to the documents. Go to https://www.ferc.gov/ferc-online/overview to register for eSubscription.
    Additional information about the project amendment is available
from the Commission's Office of External Affairs, at (866) 208-FERC, or
on the FERC website at www.ferc.gov using the eLibrary link. Click on
the eLibrary link, click on ``General Search'' and enter the docket
number in the ``Docket Number'' field. Be sure you have selected an
appropriate date range. For assistance, please contact FERC Online
Support at<EMAIL_ADDRESS>or<PHONE_NUMBER>, or for TTY,
contact<PHONE_NUMBER>. The eLibrary link also provides access to the
texts of all formal documents issued by the Commission, such as orders,
notices, and rulemakings.
    Public sessions or site visits will be posted on the Commission's
calendar located at www.ferc.gov/EventCalendar/EventsList.aspx along
with other related information.

    Dated: May 4, 2021.
Kimberly D. Bose,
Secretary.
[FR Doc. 2021-09828 Filed 5-7-21; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 22 (Monday, February 3, 2014)]
[Rules and Regulations]
[Pages 6088-6092]
[FR Doc No: 2014-02150]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 17

[Docket No. FDA-2014-N-0113]

Maximum Civil Money Penalty Amounts; Civil Money Penalty
Complaints

AGENCY: Food and Drug Administration, HHS.

ACTION: Direct final rule.

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

SUMMARY: The Food and Drug Administration (FDA) is issuing a new
regulation to adjust for inflation the maximum civil money penalty
(CMP) amounts for the various CMP authorities within our jurisdiction
and to amend the process for initiating certain CMP

administrative actions. We are taking these actions to comply with the
Federal Civil Penalties Inflation Adjustment Act of 1990 (FCPIAA), as
amended, and to streamline our internal processes. The last CMP
adjustment was published in the Federal Register of November 12, 2008,
and the FCPIAA requires Federal Agencies to adjust their CMPs at least
once every 4 years. We are using direct final rulemaking for these
actions because the Agency expects that there will be no significant
adverse comment on the rule. We are concurrently proposing and
soliciting comments on this rule. If significant adverse comments are
received, we will withdraw this final rule and address the comments in
a subsequent final rule. FDA will not provide additional opportunity
for comment.

DATES: This rule is effective June 18, 2014, without further notice,
unless FDA receives significant adverse comment by April 21, 2014. If
we receive no timely significant adverse comments, we will publish a
document in the Federal Register before May 19, 2014, confirming the
effective date of the direct final rule. If we receive any timely
significant adverse comments, we will publish a document in the Federal
Register withdrawing this direct final rule before June 18, 2014.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2014-
N-0113, by any of the following methods.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     Mail/Hand delivery/Courier (for paper submissions):
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency name
and Docket No. FDA-2014-N-0113 for this rulemaking. All comments
received may be posted without change to http://www.regulations.gov,
including any personal information provided. For additional information
on submitting comments, see the ``Comments'' heading of the
SUPPLEMENTARY INFORMATION section of this document.
    Docket: For access to the docket to read background documents or
comments received, go to http://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: Jarilyn Dupont, Office of Policy, Food
and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD
20903,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The last CMP adjustment was published in the
Federal Register of November 12, 2008 (73 FR 66750).

I. Background

A. CMP Amounts

    FDA is amending Sec.  17.2 (21 CFR 17.2) to update the maximum CMP
amounts. In general, FCPIAA requires Federal Agencies to issue
regulations to adjust for inflation each CMP penalty provided by law
within their jurisdiction. (28 U.S.C. 2461 note, as amended by the Debt
Collection Improvement Act of 1996 (31 U.S.C. 3701)). FCPIAA directs
Agencies to adjust the CMP provided by law by October 23, 1996, and to
make additional adjustments at least once every 4 years thereafter. The
adjustments are based on changes in the cost of living, and the FCPIAA
defines the cost of living adjustment as the percentage (if any) for
each civil monetary penalty by which the Consumer Price Index for the
month of June of the calendar year preceding the adjustment, exceeds
the Consumer Price Index for the month of June of the calendar year in
which the amount of such civil monetary penalty was last set or
adjusted pursuant to law (28 U.S.C. 2461 note, section 5(b)).
    FCPIAA also prescribes a rounding method based on the size of the
penalty after the calculated increase, but states that the adjustment
of a CMP may not exceed 10 percent of the penalty. FCPIAA defines a CMP
as any penalty, fine, or other sanction that is for a specific monetary
amount as provided by Federal law; or has a maximum amount provided for
by Federal law; and is assessed or enforced by an agency pursuant to
Federal law; and is assessed or enforced pursuant to an administrative
proceeding or a civil action in the Federal Courts (28 U.S.C. 2461
note, section 3(2)).

B. CMP Complaints

    Currently, under Sec.  17.5(a) (21 CFR 17.5(a)), CMP complaints
against retailers of tobacco products may only be signed by attorneys
in FDA's Office of the Chief Counsel (OCC). Given the routine nature of
many of these CMPs, FDA is amending this regulation to permit the Chief
Counsel to designate other FDA staff, such as those in FDA's Center for
Tobacco Products, to sign a tobacco retailer CMP complaint.
    Based on FDA's experience, the large majority of the tobacco
retailer complaints to date have involved alleged violations of the
requirement to not sell cigarettes and smokeless tobacco to any person
younger than 18 years of age or to verify age in accordance with 21 CFR
1140.14(b). These complaints have almost always been straightforward,
they involve simple fact patterns, and they do not require a complex
legal analysis. Over time, such CMP complaints have increased in
volume, and we anticipate that the volume will continue to be
relatively high.
    We have determined that, with certain limitations and controls,
non-attorney staff outside OCC can carry out the function of reviewing
the evidence and signing the tobacco retailer CMP complaints in
appropriate circumstances. The proposed amendment to Sec.  17.5(a)
would give this decisionmaking authority to the Chief Counsel, who
could ensure the authority to sign complaints is only given to
appropriate staff and under appropriate circumstances. Under the
proposal, the Chief Counsel would have the authority to set and revise
limitations and controls, and to broaden, limit, or rescind any
authorizations to sign tobacco retailer CMP complaints.
    The limitations could include, for example, limiting the delegation
to situations where the CMP amount is below a certain dollar value; the
CMP involves specified tobacco retailer charges that OCC has determined
are routine and predictable and do not require a complex legal
analysis; and involve charges for which FDA has developed OCC-approved
templates, parameters, and procedures. The controls could include, for
example, an audit or other quality review.
    FDA is publishing this rule as a direct final rule without prior
proposal and comment because we view these as noncontroversial
amendments and anticipate no significant adverse comment. This rule
incorporates requirements specifically set forth in the FCPIAA
requiring FDA to issue a regulation implementing inflation adjustments
for all its CMP provisions. These technical changes, required by law,
do not substantively alter the existing regulatory framework, nor do
they in any way affect the terms under which CMPs are assessed by FDA.
The formula for the amount of the penalty

adjustment is prescribed by Congress in the FCPIAA, and these changes
are not subject to the exercise of discretion by FDA. The amendment to
Sec.  17.5(a) changes an internal process.
    This direct final rule:
     Revises the table in Sec.  17.2 to adjust the maximum CMP
amounts for inflation as prescribed by FCPIAA.
     Revises Sec.  17.5(a) to provide authority for the Chief
Counsel to delegate the responsibility for initiating a CMP
administrative action against a tobacco retailer.

II. Environmental Impact

    The Agency has determined under 21 CFR 25.33 that this action is of
a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

III. Paperwork Reduction Act

    This final rule contains no collection of information. Therefore,
clearance by the Office of Management and Budget under the Paperwork
Reduction Act of 1995 is not required.

IV. Federalism

    FDA has analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. FDA has determined that the rule
does not contain policies that have substantial direct effects 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. Accordingly, the Agency has concluded
that the rule does not contain policies that have federalism
implications as defined in the Executive order and, consequently, a
federalism summary impact statement is not required.

V. Analysis of Impacts

    FDA has examined the impacts of the final rule under Executive
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4). Executive Orders 12866 and 13563 direct Agencies to assess all
costs and benefits of available regulatory alternatives and, when
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety, and other advantages; distributive impacts; and
equity). The Agency believes that this final rule is not a significant
regulatory action under Executive Order 12866.
    The Regulatory Flexibility Act requires Agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because the final rule simply adjusts the maximum
amount of CMPs administered by FDA as required by the FCPIAA, and
because the proposed rule makes a change to FDA's internal processes,
the Agency certifies that the final rule will not have a significant
economic impact on a substantial number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that Agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $141 million, using the most current (2012) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
final rule to result in any 1-year expenditure that would meet or
exceed this amount.

VI. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

List of Subjects in 21 CFR Part 17

    Administrative practice and procedure, Penalties.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and the
Public Health Service Act, and under authority delegated to the
Commissioner of Food and Drugs, 21 CFR part 17 is amended as follows:

PART 17--CIVIL MONEY PENALTIES HEARINGS

0
1. The authority citation for 21 CFR part 17 continues to read as
follows:

    Authority:  21 U.S.C. 331, 333, 337, 351, 352, 355, 360, 360c,
360f, 360i, 360j, 371; 42 U.S.C. 262, 263b, 300aa-28; 5 U.S.C. 554,
555, 556, 557.

0
2. Section 17.2 is revised to read as follows:

Sec.  17.2  Maximum penalty amounts.

    The following table shows maximum civil monetary penalties
associated with the statutory provisions authorizing civil monetary
penalties under the Federal Food, Drug, and Cosmetic Act or the Public
Health Service Act.

          Civil Monetary Penalties Authorities Administered by FDA and Adjusted Maximum Penalty Amounts
----------------------------------------------------------------------------------------------------------------
                                       Former
                                       maximum                                Date of last     Adjusted maximum
          U.S.C. Section               penalty         Assessment method     penalty figure   penalty amount (in
                                     amount (in                               or adjustment        dollars)
                                      dollars)
----------------------------------------------------------------------------------------------------------------
                                                    21 U.S.C.
----------------------------------------------------------------------------------------------------------------
333(b)(2)(A).....................          60,000  For each of the first               2013  65,000.
                                                    two violations in any
                                                    10-year period.
333(b)(2)(B).....................       1,200,000  For each violation after            2013  1,275,000.
                                                    the second conviction
                                                    in any 10-year period.
333(b)(3)........................         120,000  Per violation...........            2013  130,000.
333(f)(1)(A).....................          16,500  Per violation...........            2008  16,500 (not
                                                                                adjusted).
333(f)(1)(A).....................       1,200,000  For the aggregate of                2013  1,275,000.
                                                    violations.
333(f)(2)(A).....................          55,000  Per individual..........            2013  60,000.
333(f)(2)(A).....................         300,000  Per ``any other person''            2013  325,000.
333(f)(2)(A).....................         600,000  For all violations                  2013  650,000.
                                                    adjudicated in a single
                                                    proceeding.

333(f)(3)(A).....................          10,000  For all violations                  2013  11,000.
                                                    adjudicated in a single
                                                    proceeding.
333(f)(3)(B).....................          10,000  For each day the                    2013  11,000.
                                                    violation is not
                                                    corrected after a 30-
                                                    day period following
                                                    notification until the
                                                    violation is corrected.
333(f)(4)(A)(i)..................         250,000  Per violation...........            2013  275,000.
333(f)(4)(A)(i)..................       1,000,000  For all violations                  2013  1,075,000.
                                                    adjudicated in a single
                                                    proceeding.
333(f)(4)(A)(ii).................         250,000  For the first 30-day                2013  275,000.
                                                    period (or any portion
                                                    thereof) of continued
                                                    violation following
                                                    notification.
333(f)(4)(A)(ii).................       1,000,000  For any 30-day period,              2013  1,075,000.
                                                    where the amount
                                                    doubles for every 30-
                                                    day period of continued
                                                    violation after the
                                                    first 30-day violation.
333(f)(4)(A)(ii).................      10,000,000  For all violations                  2013  10,850,000.
                                                    adjudicated in a single
                                                    proceeding.
333(f)(9)(A).....................          15,000  Per violation...........            2009  15,000 (not
                                                                                adjusted).
333(f)(9)(A).....................       1,000,000  For all violations                  2013  1,050,000.
                                                    adjudicated in a single
                                                    proceeding.
333(f)(9)(B)(i)(I)...............         250,000  Per violation...........            2013  275,000.
333(f)(9)(B)(i)(I)...............       1,000,000  For all violations                  2013  1,050,000.
                                                    adjudicated in a single
                                                    proceeding.
333(f)(9)(B)(i)(II)..............         250,000  For the first 30-day                2013  275,000.
                                                    period (or any portion
                                                    thereof) of continued
                                                    violation following
                                                    notification.
333(f)(9)(B)(i)(II)..............       1,000,000  For any 30-day period,              2013  1,050,000.
                                                    where the amount
                                                    doubles for every 30-
                                                    day period of continued
                                                    violation after the
                                                    first 30-day violation.
333(f)(9)(B)(i)(II)..............      10,000,000  For all violations                  2013  10,525,000.
                                                    adjudicated in a single
                                                    proceeding.
333(f)(9)(B)(ii)(I)..............         250,000  Per violation...........            2013  275,000.
333(f)(9)(B)(ii)(I)..............       1,000,000  For all violations                  2013  1,050,000.
                                                    adjudicated in a single
                                                    proceeding.
333(f)(9)(B)(ii)(II).............         250,000  For the first 30-day                2013  275,000.
                                                    period (or any portion
                                                    thereof) of continued
                                                    violation following
                                                    notification.
333(f)(9)(B)(ii)(II).............       1,000,000  For any 30-day period,              2013  1,050,000.
                                                    where the amount
                                                    doubles for every 30-
                                                    day period of continued
                                                    violation after the
                                                    first 30-day violation.
333(f)(9)(B)(ii)(II).............      10,000,000  For all violations                  2013  10,525,000.
                                                    adjudicated in a single
                                                    proceeding.
333(g)(1)........................         250,000  For the first violation             2013  275,000.
                                                    in any 3-year period.
333(g)(1)........................         500,000  For each subsequent                 2013  550,000.
                                                    violation in any 3-year
                                                    period.
333 note.........................             250  For the second violation            2009  250 (not adjusted).
                                                    (following a first
                                                    violation with a
                                                    warning) within a 12-
                                                    month period by a
                                                    retailer with an
                                                    approved training
                                                    program.
333 note.........................             500  For the third violation             2009  500 (not adjusted).
                                                    within a 24-month
                                                    period by a retailer
                                                    with an approved
                                                    training program.
333 note.........................           2,000  For the fourth violation            2009  2,000 (not
                                                    within a 24-month                         adjusted).
                                                    period by a retailer
                                                    with an approved
                                                    training program.
333 note.........................           5,000  For the fifth violation             2009  5,000 (not
                                                    within a 36-month                         adjusted).
                                                    period by a retailer
                                                    with an approved
                                                    training program.
333 note.........................          10,000  For the sixth or                    2013  11,000.
                                                    subsequent violation
                                                    within a 48-month
                                                    period by a retailer
                                                    with an approved
                                                    training program.
333 note.........................             250  For the first violation             2009  250 (not adjusted).
                                                    by a retailer without
                                                    an approved training
                                                    program.
333 note.........................             500  For the second violation            2009  500 (not adjusted).
                                                    within a 12-month
                                                    period by a retailer
                                                    without an approved
                                                    training program.
333 note.........................           1,000  For the third violation             2013  1,100.
                                                    within a 24-month
                                                    period by a retailer
                                                    without an approved
                                                    training program.
333 note.........................           2,000  For the fourth violation            2009  2,000 (not
                                                    within a 24-month                         adjusted).
                                                    period by a retailer
                                                    without an approved
                                                    training program.
333 note.........................           5,000  For the fifth violation             2009  5,000 (not
                                                    within a 36-month                         adjusted).
                                                    period by a retailer
                                                    without an approved
                                                    training program.
333 note.........................          10,000  For the sixth or                    2013  11,000.
                                                    subsequent violation
                                                    within a 48-month
                                                    period by a retailer
                                                    without an approved
                                                    training program.
335b(a)..........................         300,000  Per violation for an                2013  325,000.
                                                    individual.
335b(a)..........................       1,200,000  Per violation for ``any             2013  1,275,000.
                                                    other person''.
360pp(b)(1)......................           1,100  Per violation per person            2008  1,100 (not
                                                                                adjusted).
360pp(b)(1)......................         355,000  For any related series              2013  375,000.
                                                    of violations.
----------------------------------------------------------------------------------------------------------------
                                                    42 U.S.C.
----------------------------------------------------------------------------------------------------------------
263b(h)(3).......................          11,000  Per violation...........            2008  11,000 (not
                                                                                adjusted).
300aa-28(b)(1)...................         120,000  Per occurrence..........            2013  130,000.
----------------------------------------------------------------------------------------------------------------

0
3. In Sec.  17.5, revise paragraph (a) to read as follows:

Sec.  17.5  Complaint.

    (a) The Center with principal jurisdiction over the matter involved
shall begin all administrative civil money penalty actions by serving
on the respondent(s) a complaint signed by the Office of the Chief
Counsel attorney for the Center and by filing a copy of the complaint
with the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For a
civil money penalty action against retailers of tobacco products, the
complaint may be signed by any Agency employee designated by the Chief
Counsel.
* * * * *

    Dated: January 28, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-02150 Filed 1-31-14; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 88, Number 137 (Wednesday, July 19, 2023)]
[Rules and Regulations]
[Pages 46068-46071]
[FR Doc No: 2023-15178]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2023-0011; Project Identifier MCAI-2022-00211-T;
Amendment 39-22478; AD 2023-12-19]
RIN 2120-AA64

Airworthiness Directives; Airbus SAS Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: The FAA is superseding Airworthiness Directive (AD) 2013-07-
03, which applied to all Airbus SAS Model A330-200, A330-200 Freighter,
A330-300, A340-200, and A340-300 series airplanes; and Model A340-541
and A340-642 airplanes. AD 2013-07-03 required repetitive inspections
for degradation of the bogie pivot pins and for any cracks and damage
of the pivot pin bushes of the main and central landing gear; an
inspection of the affected bogie pivot pins for corrosion and base
metal cracks; and repairing or replacing bogie pivot pins and pivot pin
bushes, if necessary. This AD was prompted by development of a
modification that address the unsafe condition and a determination that
a parts installation prohibition is necessary. This AD continues to
require certain actions in AD 2013-07-03, add an optional modification
that would terminate the repetitive inspections, and add a parts
installation prohibition, as specified in a European Union Aviation
Safety Agency (EASA), which is incorporated by reference. The FAA is
issuing this AD to address the unsafe condition on these products.

DATES: This AD is effective August 23, 2023.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of August 23,
2023.

ADDRESSES:
    AD Docket: You may examine the AD docket at regulations.gov under
Docket No. FAA-2023-0011; 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, the mandatory continuing airworthiness
information (MCAI), 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.
    Material Incorporated by Reference:
     For material incorporated by reference in this AD, contact
EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone +49 221
8999 000; email [email protected]; website easa.europa.eu. You may
find this material on the EASA website at ad.easa.europa.eu.
     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>. It is also available in the AD docket at
regulations.gov under Docket No. FAA-2023-0011.

FOR FURTHER INFORMATION CONTACT: Vladimir Ulyanov, Aviation Safety
Engineer, FAA, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590;
telephone<PHONE_NUMBER>; email [email protected].

SUPPLEMENTARY INFORMATION:

Background

    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 to supersede AD 2013-07-03, Amendment 39-17407 (78 FR
21227, April 10, 2013) (AD 2013-07-03). AD 2013-07-03 applied to all
Airbus SAS Model A330-200, A330-200 Freighter, A330-300, A340-200, and
A340-300 series airplanes; and Model A340-541 and A340-642 airplanes.
AD 2013-07-03 required repetitive inspections for degradation of the
bogie pivot pins and for any cracks and damage of the pivot pin bushes
of the main and central landing gear; an inspection of the affected
bogie pivot pins for corrosion and base metal cracks; and repairing or
replacing bogie pivot pins and pivot pin bushes, if necessary. The FAA
issued AD 2013-07-03 to detect and correct cracks and damage to the
main and central landing gear, which could result in the collapse of
the landing gear and adversely affect the airplane's continued safe
flight and landing.
    The NPRM published in the Federal Register on January 13, 2023 (88
FR 2283). The NPRM was prompted by AD 2022-0025R2, dated August 9,
2022, issued by EASA (EASA AD 2022-0025R2) (also referred to as the
MCAI). The MCAI states that since EASA issued AD 2012-0053, dated March
30, 2012, Airbus developed mod 207165 and mod 207649, introducing a new
bogie pivot pin for certain main landing gear. The MCAI includes the
modification as an optional terminating action for the repetitive
inspections. The MCAI also determined that a parts installation
prohibition is necessary. The MCAI also states that main and central
landing gear overhauls contains actions that are equivalent to those
required by EASA AD 2012-0053, dated March 30, 2012, and therefore,
credit is provided for those actions.
    You may examine the MCAI in the AD docket at regulations.gov under
Docket No. FAA-2023-0011.
    In the NPRM, the FAA proposed to continue to require certain
actions in AD 2013-07-03, add an optional modification that would
terminate the repetitive inspections, and add a parts installation
prohibition, as specified in EASA AD 2022-0025R2. The FAA is issuing
this AD to address cracks and damage to the main and central landing
gear. The unsafe condition, if not addressed, could result in the
collapse of the landing gear and consequent damage to the airplane and
injury to occupants.

Discussion of Final Airworthiness Directive

Comments

    The FAA received comments from Air Line Pilots Association,
International (ALPA), who supported the NPRM without change.
    The FAA received additional comments from Delta Air Lines (Delta).
The following presents the comments received on the NPRM and the FAA's
response to each comment.

Request for Additional Exception to the MCAI

    Delta requested an exception to provide a terminating action as a
means of compliance with the proposed optional terminating action of
paragraph (g) of the proposed AD. Delta stated that service information
specified in EASA 2022-0025R2 for modifying the main landing gear (MLG)
while on the airplane wing references other information that seems to
allow for modification of the MLG while it is off the wing. Delta
received confirmation from Airbus that it is acceptable to replace
unmodified MLG with MLG that has been previously modified off the wing.
Delta also pointed out that the service information specified in EASA
2022-0025R2 specified an AMM task that is intended for use while the
MLG is on the wing and an exception would need to accommodate a
reference to an AMM task that is intended for use while the MLG is off
the wing.
    The FAA agrees to add an exception to paragraph (h) of this AD that
allows for installing a MLG that was modified off the wing. Installing
a previously modified MLG that was modified off the wing is acceptable
for the optional terminating action that terminates the repetitive
inspections required by this AD.

Conclusion

    This product has been approved by the aviation authority of another
country and is approved for operation in the United States. Pursuant to
the FAA's bilateral agreement with this State of Design Authority, it
has notified the FAA of the unsafe condition described in the MCAI
referenced above. The FAA reviewed the relevant data, considered the
comments received, and determined that air safety requires adopting
this AD as proposed. Accordingly, the FAA is issuing this AD to address
the unsafe condition on this product. Except for minor editorial
changes, and any other changes described previously, this AD is adopted
as proposed in the NPRM. None of the changes will increase the economic
burden on any operator.

Related Service Information Under 1 CFR Part 51

    EASA AD 2022-0025R2 specifies procedures for repetitive detailed
inspections for degradation of the bogie pivot pins and for any cracks
and damage of the pivot pin bushes of the main and central landing
gear; an non-destructive test (NDT) inspection (i.e., magnetic particle
inspection) of the affected bogie pivot pins for corrosion and base
metal cracks; and corrective actions if necessary (i.e., repairing or
replacing bogie pivot pins and pivot pin bushes). EASA AD 2022-0025R2
also provides an optional modification, which terminates the repetitive
inspections. EASA AD 2022-0025R2 also includes a parts installation
prohibition for the affected parts. 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 115 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.
               Action                        Labor cost           Parts cost        product         operators
----------------------------------------------------------------------------------------------------------------
Retained actions from AD 2013-07-03.  22 work-hours x $85 per              $0           $1,870         $215,050
                                       hour = $1,870.
----------------------------------------------------------------------------------------------------------------

                 Estimated Costs for New Optional Action
------------------------------------------------------------------------
           Labor cost                 Parts cost       Cost per product
------------------------------------------------------------------------
24 work-hours x $85 per hour =    Up to $30,150.....  Up to $32,190.
 $2,040.
------------------------------------------------------------------------

                 Estimated Costs of On-Condition Actions
------------------------------------------------------------------------
           Labor cost                 Parts cost       Cost per product
------------------------------------------------------------------------
Up to 8 work-hours x $85 per      Up to $2,122......  Up to $2,802.
 hour = $680.
------------------------------------------------------------------------

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.

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:
0
a. Removing Airworthiness Directive (AD) 2013-07-03, Amendment 39-17407
(78 FR 21227, April 10, 2013); and
0
b. Adding the following new AD:

2023-12-19 Airbus SAS: Amendment 39-22478; Docket No. FAA-2023-0011;
Project Identifier MCAI-2022-00211-T.

(a) Effective Date

    This airworthiness directive (AD) is effective August 23, 2023.

(b) Affected ADs

    This AD replaces AD 2013-07-03, Amendment 39-17407 (78 FR 21227,
April 10, 2013) (AD 2013-07-03).

(c) Applicability

    This AD applies to all Airbus SAS airplanes identified in
paragraphs (c)(1) through (5) of this AD; certificated in any
category.
    (1) Model A330-201, -202, -203, -223, -223F, -243 and -243F
airplanes.
    (2) Model A330-301, -302, -303, -321, -322, -323, -341, -342,
and -343 airplanes.
    (3) Model A340-211, -212, and -213 airplanes.
    (4) Model A340-311, -312, and -313 airplanes.
    (5) Model A340-541 and -642 airplanes.

(d) Subject

    Air Transport Association (ATA) of America Code 32, Landing
gear.

(e) Unsafe Condition

    This AD was prompted by reports of cracks in the bogie pivot pin
of the main and central landing gear bogie beams. Investigation
indicated these findings were the result of material heating due to
friction between the bogie pivot pin and bush, leading to chrome
detachment and chrome dragging on the bogie pivot pin. Since
issuance of AD 2013-07-03, an optional terminating modification was
developed and it was also determined that a parts installation
prohibition is necessary. The FAA is issuing this AD to address
cracks and damage to the main and central landing gear. The unsafe
condition, if not addressed, could result in the collapse of the
landing gear and consequent damage to the airplane and injury to
occupants.

(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, European Union Aviation Safety Agency (EASA) AD
2022-0025R2, dated August 9, 2022 (EASA AD 2022-0025R2).

(h) Exceptions to EASA AD 2022-0025R2

    (1) Where EASA AD 2022-0025R2 refers to March 1, 2022 (the
effective date of EASA AD 2022-0025, dated February 15, 2022), this
AD requires using the effective date of this AD.
    (2) Where EASA AD 2022-0025R2 refers to April 13, 2012 (the
effective date of EASA AD 2012-0053, dated March 30, 2012), this AD
requires using May 15, 2013 (the effective date of AD 2013-07-03).
    (3) Where paragraph (4) of EASA AD 2022-0025R2 specifies
corrective actions for the non-destructive test (NDT) inspection,
replace the text ``the base metal of the affected part is found
corroded'' with ``the bogie pivot pin is found corroded or the base
metal is found cracked.''
    (4) This AD does not adopt the ``Remarks'' section of EASA AD
2022-0025R2.
    (5) For the terminating modification specified in paragraph (7)
of EASA AD 2022-0025R2, replacement of the unmodified main landing
gear (MLG) with MLG that has been previously modified off the
airplane is acceptable for compliance, provided the modification was
done as specified in the applicable Safran Landing Systems Service
Bulletin A33/34-32-315, dated November 28, 2017; A33/34-32-319,
dated September 13, 2018; or A33/34-32-320, dated September 13,
2018; and the test after the modification was done as specified in
AMM task 32-11-11-400-801-A.

(i) No Reporting Requirement

    Although the service information referenced in EASA AD 2022-
0025R2 specifies to submit certain information to the

manufacturer, this AD does not include that requirement.

(j) Additional AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
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 responsible Flight Standards Office, as
appropriate. If sending information directly to the International
Validation Branch, send it to the attention of the person identified
in paragraph (k) of this AD. Information may be emailed to: [email protected].
    (i) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the responsible Flight Standards Office.
    (ii) AMOCs approved previously for AD 2013-07-03 are approved as
AMOCs for the corresponding provisions of EASA AD 2022-0025R2 that
are required by paragraph (g) of this AD.
    (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, 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): Except as required by
paragraph (j)(2) of this AD, if any service information contains
procedures or tests that are identified as RC, those 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.

(k) Additional Information

    For more information about this AD, contact Vladimir Ulyanov,
Aviation Safety Engineer, FAA, 1600 Stewart Avenue, Suite 410,
Westbury, NY; telephone<PHONE_NUMBER>; email
[email protected].

(l) 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 2022-0025R2,
dated August 9, 2022.
    (ii) [Reserved]
    (3) For EASA AD 2022-0025R2, contact EASA, Konrad-Adenauer-Ufer
3, 50668 Cologne, Germany; telephone +49 221 8999 000; email
[email protected]; website easa.europa.eu. You may find this EASA
AD on the EASA website at 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>.
    (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 protected], or go to: www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on June 21, 2023.
Michael Linegang,
Acting Director, Compliance & Airworthiness Division, Aircraft
Certification Service.
[FR Doc. 2023-15178 Filed 7-18-23; 8:45 am]
BILLING CODE 4910-13-P