[Federal Register Volume 80, Number 34 (Friday, February 20, 2015)]
[Rules and Regulations]
[Pages 9217-9218]
[FR Doc No: 2015-03500]

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DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

49 CFR Parts 171, 172, 173, and 175

[Docket No. PHMSA-2009-0095 (HM-224F)]
RIN 2137-AE44

Hazardous Materials: Transportation of Lithium Batteries

AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA),
DOT.

ACTION: Final rule; extension of compliance date.

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

SUMMARY: PHMSA is extending for modes of transportation other than air
the mandatory compliance date of a final rule published on August 6,
2014, under Docket No. HM-224F from February 6, 2015, until August 7,
2015. This extension is made in response to formal comments received
from multiple stakeholders outlining challenges faced by the regulated
community in fully implementing the provisions of the final rule by the
February 6, 2015 mandatory compliance date.

DATES: The compliance date for the final rule published August 6, 2014,
at 79 FR 46012, is extended until August 7, 2015.

FOR FURTHER INFORMATION CONTACT: Vincent Babich or Steven Webb
Standards and Rulemaking Division, Pipeline and Hazardous Materials
Safety Administration, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: On August 6, 2014 [79 FR 46012], PHMSA in
consultation with the Federal Aviation Administration (FAA) published a
final rule under Docket No. PHMSA-2009-0095 (HM-224F) modifying
requirements governing the transportation of lithium cells and
batteries. The final rule revised hazard communication and packaging
provisions for lithium batteries to harmonize the Hazardous Materials
Regulations (HMR; CFR parts 171-180) with applicable provisions of the
United Nations (UN) Model Regulations, the International Civil Aviation
Organization's Technical Instructions for the Safe Transport of
Dangerous Goods by Air (ICAO Technical Instructions) and the
International Maritime Dangerous Goods (IMDG) Code. In the August 6,
2014 final rule, PHMSA authorized a mandatory compliance date of
February 6, 2015 (six months after publication in the Federal Register)
for shippers to incorporate the new requirements into standard
operating procedures and complete training of affected personnel.
    The Retail Industry Leaders Association, the Food Marketing
Institute, the National Retail Federation, and the Rechargeable Battery
Association submitted a joint request for an extension of six months to
the current mandatory compliance date. These groups contend that the
six month transitional period adopted in the final rule did not provide
sufficient time to comply with the new requirements and has proven
extremely challenging for the retail industry to implement in
particular for surface transportation. The request notes that
``generally, the new regulations require that domestic ground shipments
of products with lithium batteries adhere to shipping standards
previously only required for international air and sea
transportation''. The groups further note that the detailed information
necessary for compliance, such as the specific

number of lithium cells or batteries contained in a package and whether
a package contains lithium ion or lithium metal cells or batteries, as
required by Sec.  173.185(c)(3), does not currently exist in any format
that the retail sector can access and utilize. In addition the
requestors state that tens of thousands of consumer products may be
impacted by the rule, and estimate that to date, the necessary
information has been obtained from retail suppliers for less than 25%
of the affected products. Furthermore, they relate that since August
2014, retail businesses and their suppliers have been working
diligently to develop information technology (IT) systems and business
processes to identify consumer products impacted by the regulation.
Systematic solutions are being developed but will take additional time
to implement. They estimate that a minimum of six additional months is
necessary to identify all affected products and build the IT
infrastructure necessary to effectively implement the regulations.
Finally, the commenters point out that the new provisions require the
developing, tracking, and implementing of training programs for
hundreds of thousands of employees to enable them to execute the
nuanced marking and labeling requirements of the final rule.
    PHMSA appreciates the additional information submitted and has
reviewed the information in conjunction with the information considered
during the rulemaking process. Based on this review, PHMSA believes the
additional arguments and justification provided by the commenters have
merit and that an extension of the mandatory compliance date for modes
of transportation other than aircraft is warranted. PHMSA recognizes
that the primary focus of the HM-224F final rulemaking as outlined in
published notices preceding the final rule was to align the
requirements of the HMR for air transportation of lithium batteries
with those of the ICAO Technical Instructions. PHMSA believes that
maintaining the February 6, 2015 compliance date for air transport is
appropriate and important for aviation safety and is therefore
maintaining the February 6, 2015 effective date for offering,
acceptance, and transportation by aircraft. Therefore, in consultation
with the FAA and consistent with the information set forth in the joint
request, this extension does not apply to transportation by aircraft.
In the event an air carrier becomes aware of a non-compliant shipment
offered to it, the air carrier should report the incident to the FAA in
addition to taking specific actions required by the regulations as to
that shipment. For questions regarding reporting of such incidents,
carriers may contact the nearest FAA Regional or Field Security Office
by telephone or electronically.
    In summary, in response to commenters' requests PHMSA is extending
the mandatory compliance date for the final rule published under Docket
No. HM-224F on August 6, 2014, until August 7, 2015 for all modes other
than transportation by aircraft to allow additional time to implement
the requirements of the rule. The mandatory compliance date of February
6, 2015 remains in effect with respect to offering, acceptance and
transportation by aircraft.

    Issued in Washington, DC, on February 13, 2015 under authority
delegated in 49 CFR 1.97.
Timothy P. Butters,
Acting Administrator.
[FR Doc. 2015-03500 Filed 2-19-15; 8:45 am]
BILLING CODE 4910-60-P


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

	OFFICE OF PREVENTION, PESTICIDE

	AND TOXIC SUBSTANCES

  SEQ CHAPTER \h \r 1 MEMORANDUM

Date:  April 2, 2008

SUBJECT:	Ingredient:  Pyridalyl         Title:  Addendum to PP#s 2F6459
& 3E6592.  Pyridalyl in/on Cotton, Fruiting Vegetables, Leafy
Vegetables, Head & Stem Brassica Vegetables, Brassica Leafy Greens, and
Turnip Greens, Shrubs, Ornamentals and Non-bearing Trees.  Health
Effects Division (HED) Risk Assessment.

PC Code:  295149	DP Barcode: D351059

MRID No.:  None	Registration No.: None

Petition No.: None	Regulatory Action: None

Assessment Type: None	Reregistration Case No.: None

TXR No.: 0054837	CAS No.: None

FROM:	Lisa Austin, Ph.D., Toxicologist  SEQ CHAPTER \h \r 1

		Registration Action Branch 1

		Health Effects Division (7509P)

THROUGH:	Dana Vogel, Branch Chief

		Registration Action Branch 1

		Health Effects Division (7509P)

		Pv Shah, Ph.D., Acting Branch Chief

		Inerts

		Registration Branch (7510P)

TO:		Olga Odiott  SEQ CHAPTER \h \r 1   SEQ CHAPTER \h \r 1

		Insecticide Branch

		Registration Division (7505P)

I.	 CONCLUSIONS

This memo serves as an update to the previous risk assessment of
pyridalyl (Memo, M. Clock-Rust, 8/26/04, D301446).  The previous risk
assessment conditionally required a 28-day inhalation toxicity study.
HED has reconsidered this requirement and is now granting a waiver for a
28 day inhalation toxicity study for the proposed uses because pyridalyl
is in toxicity category IV via the inhalation route, has a low vapor
pressure (not likely to be volatilized significantly) and the calculated
inhalation MOEs range from 782-82,000.

Page   PAGE  1  of   NUMPAGES  2


[Federal Register Volume 76, Number 215 (Monday, November 7, 2011)]
[Rules and Regulations]
[Pages 68638-68641]
[FR Doc No: 2011-28640]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R03-OAR-2011-0773; FRL-9487-6]

Approval and Promulgation of Air Quality Implementation Plans;
Virginia; Revision to Nitrogen Oxides Budget Trading Program

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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SUMMARY: EPA is taking direct final action to approve a revision to the
Virginia State Implementation Plan (SIP). The revision pertains to
regulatory language in its nitrogen oxides (NOX) Budget
Trading Program that inadvertently ended its NOX budget at
the end of the 2008 ozone season. EPA is approving this revision in
accordance with the requirements of the Clean Air Act (CAA).

DATES: This rule is effective on January 6, 2012 without further
notice, unless EPA receives adverse written comment by December 7,
2011. If EPA receives such comments, it will publish a timely
withdrawal of the direct final rule in the Federal Register and inform
the public that the rule will not take effect.

ADDRESSES: Submit your comments, identified by Docket ID Number EPA-
R03-OAR-2011-0773 by one of the following methods:
    A. www.regulations.gov. Follow the on-line instructions for
submitting comments.
    B. Email<EMAIL_ADDRESS>    C. Mail: EPA-R03-OAR-2011-0773, Cristina Fernandez, Associate
Director, Office of Air Program Planning, Mailcode 3AP30, U.S.
Environmental Protection Agency, Region III, 1650 Arch Street,
Philadelphia, Pennsylvania 19103.
    D. Hand Delivery: At the previously-listed EPA Region III address.
Such deliveries are only accepted during the Docket's normal hours of
operation, and special arrangements should be made for deliveries of
boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-R03-OAR-
2011-0773. EPA's policy is that all comments received will be included
in the public docket without change, and may be made available online
at www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you

consider to be CBI or otherwise protected through www.regulations.gov
or e-mail. The www.regulations.gov Web site is an ``anonymous access''
system, which means EPA will not know your identity or contact
information unless you provide it in the body of your comment. If you
send an email comment directly to EPA without going through
www.regulations.gov, your email address will be automatically captured
and included as part of the comment that is placed in the public docket
and made available on the Internet. If you submit an electronic
comment, EPA recommends that you include your name and other contact
information in the body of your comment and with any disk or CD-ROM you
submit. If EPA cannot read your comment due to technical difficulties
and cannot contact you for clarification, EPA may not be able to
consider your comment. Electronic files should avoid the use of special
characters, any form of encryption, and be free of any defects or
viruses.
    Docket: All documents in the electronic docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, i.e., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available either electronically in www.regulations.gov or
in hard copy during normal business hours at the Air Protection
Division, U.S. Environmental Protection Agency, Region III, 1650 Arch
Street, Philadelphia, Pennsylvania 19103. Copies of the State submittal
are available at the Virginia Department of Environmental Quality, 629
East Main Street, Richmond, Virginia 23219.

FOR FURTHER INFORMATION CONTACT: Marilyn Powers,<PHONE_NUMBER>, or by
email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    Throughout this document, whenever ``we,'' ``us,'' or ``our'' is
used, we mean EPA. On September 27, 2010, the Commonwealth of Virginia
Department of Environmental Quality (VADEQ) submitted a formal revision
to its State Implementation Plan (SIP).
    The SIP revision pertains to the NOX budget established
in Virginia regulation 9VAC5 Chapter 140 Part I (NOX Budget
Trading Program), which was adopted by the Commonwealth and approved
into its SIP to meet the requirements of the NOX SIP Call.
Virginia determined that regulatory language inadvertently ended the
State budget at the end of the 2008 ozone season. Because the
NOX SIP Call requirements continue to apply to the affected
states, revision of the applicable end date in regulation 9VAC5 Chapter
140, Part I is required in order for the budget to apply to ozone
season 2009 and beyond. It should be noted that Virginia has continued
to comply with the requirements of the NOX SIP Call through
its approved Clean Air Interstate Rule (CAIR) NOX Ozone
Season Trading Program at 9VAC5 Chapter 140, Part III. As explained in
the preamble for CAIR (70 FR 25162, May 12, 2005), states could meet
the requirements of the NOX SIP Call by achieving all of the
emissions reductions required under CAIR from electric generating units
(EGUs) by participating in the CAIR Ozone Season NOX Trading
Program, and by bringing its non-EGUs that were participating in the
NOX SIP Call Budget Trading Program into the CAIR Ozone
Season NOX Trading Program using the same non-EGU budget and
applicability requirements that were in their NOX SIP Call
Budget Trading Program. Virginia chose to implement its CAIR ozone
season NOX obligations by participating in the CAIR Ozone
Season NOX Trading Program and brought their non-EGUs into
this program, which was approved into the Virginia SIP on December 28,
2007 (72 FR 73602).

II. Summary of SIP Revision

    On September 27, 2010, VADEQ submitted a SIP revision that extends
the NOX SIP Call budget beyond the 2008 ozone season. The
SIP revision consists of amendments to sections 5-140-900, 5-140-920,
and 5-140-930 that extend the EGU NOX budget of 17,091 tons
and the non-EGU budget of 4,104 tons to the 2009 ozone season and each
ozone season thereafter.

III. General Information Pertaining to SIP Submittals From the
Commonwealth of Virginia

    In 1995, Virginia adopted legislation that provides, subject to
certain conditions, for an environmental assessment (audit)
``privilege'' for voluntary compliance evaluations performed by a
regulated entity. The legislation further addresses the relative burden
of proof for parties either asserting the privilege or seeking
disclosure of documents for which the privilege is claimed. Virginia's
legislation also provides, subject to certain conditions, for a penalty
waiver for violations of environmental laws when a regulated entity
discovers such violations pursuant to a voluntary compliance evaluation
and voluntarily discloses such violations to the Commonwealth and takes
prompt and appropriate measures to remedy the violations. Virginia's
Voluntary Environmental Assessment Privilege Law, Va. Code Sec. 10.1-
1198, provides a privilege that protects from disclosure documents and
information about the content of those documents that are the product
of a voluntary environmental assessment. The Privilege Law does not
extend to documents or information (1) that are generated or developed
before the commencement of a voluntary environmental assessment; (2)
that are prepared independently of the assessment process; (3) that
demonstrate a clear, imminent and substantial danger to the public
health or environment; or (4) that are required by law.
    On January 12, 1998, the Commonwealth of Virginia Office of the
Attorney General provided a legal opinion that states that the
Privilege Law, Va. Code Sec. 10.1-1198, precludes granting a privilege
to documents and information ``required by law,'' including documents
and information ``required by Federal law to maintain program
delegation, authorization or approval,'' since Virginia must ``enforce
Federally authorized environmental programs in a manner that is no less
stringent than their Federal counterparts. * * *'' The opinion
concludes that ``[r]egarding Sec.  10.1-1198, therefore, documents or
other information needed for civil or criminal enforcement under one of
these programs could not be privileged because such documents and
information are essential to pursuing enforcement in a manner required
by Federal law to maintain program delegation, authorization or
approval.'' Virginia's Immunity law, Va. Code Sec. 10.1-1199, provides
that ``[t]o the extent consistent with requirements imposed by Federal
law,'' any person making a voluntary disclosure of information to a
state agency regarding a violation of an environmental statute,
regulation, permit, or administrative order is granted immunity from
administrative or civil penalty. The Attorney General's January 12,
1998 opinion states that the quoted language renders this statute
inapplicable to enforcement of any Federally authorized programs, since
``no immunity could be afforded from administrative, civil, or criminal
penalties because granting such immunity would not be consistent with

Federal law, which is one of the criteria for immunity.''
    Therefore, EPA has determined that Virginia's Privilege and
Immunity statutes will not preclude the Commonwealth from enforcing its
program consistent with the Federal requirements. In any event, because
EPA has also determined that a state audit privilege and immunity law
can affect only state enforcement and cannot have any impact on Federal
enforcement authorities, EPA may at any time invoke its authority under
the CAA, including, for example, sections 113, 167, 205, 211 or 213, to
enforce the requirements or prohibitions of the state plan,
independently of any state enforcement effort. In addition, citizen
enforcement under section 304 of the CAA is likewise unaffected by
this, or any, state audit privilege or immunity law.

IV. Final Action

    EPA is approving the SIP revision submitted by VADEQ on September
27, 2009 that extends the NOX SIP Call budget beyond the
2008 ozone season. EPA is publishing this rule without prior proposal
because the Agency views this as a noncontroversial amendment and
anticipates no adverse comment. However, in the ``Proposed Rules''
section of today's Federal Register, EPA is publishing a separate
document that will serve as the proposal to approve the SIP revision if
adverse comments are filed. This rule will be effective on January 6,
2012 without further notice unless EPA receives adverse comment by
December 7, 2011. If EPA receives adverse comment, EPA will publish a
timely withdrawal in the Federal Register informing the public that the
rule will not take effect. EPA will address all public comments in a
subsequent final rule based on the proposed rule. EPA will not
institute a second comment period on this action. Any parties
interested in commenting must do so at this time. Please note that if
EPA receives adverse comment on an amendment, paragraph, or section of
this rule and if that provision may be severed from the remainder of
the rule, EPA may adopt as final those provisions of the rule that are
not the subject of an adverse comment.

V. Statutory and Executive Order Reviews

A. General Requirements

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the CAA and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely approves state law as meeting Federal requirements and
does not impose additional requirements beyond those imposed by state
law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this rule does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian country located in
the state, and EPA notes that it will not impose substantial direct
costs on tribal governments or preempt tribal law.

B. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).

C. Petitions for Judicial Review

    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by January 6, 2012. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and shall not postpone the effectiveness of such rule or
action. Parties with objections to this direct final rule are
encouraged to file a comment in response to the parallel notice of
proposed rulemaking for this action published in the proposed rules
section of today's Federal Register, rather than file an immediate
petition for judicial review of this direct final rule, so that EPA can
withdraw this direct final rule and address the comment in the proposed
rulemaking. This action to extend Virginia's budget under the
NOX SIP Call may not be challenged later in proceedings to
enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Nitrogen dioxide, Ozone, Sulfur oxides.

    Dated: October 25, 2011.
W.C. Early,
Acting Regional Administrator, Region III.
    40 CFR Part 52 is amended as follows:

PART 52--[AMENDED]

0
1. The authority citation for 40 CFR part 52 continues to read as
follows:

    Authority: 42 U.S.C. 7401 et seq.

Subpart VV--Virginia

0
2. In Sec.  52.2420, the table in paragraph (c) is amended by revising
the entries for Sections 5-140-900, 5-140-920, and 5-140-930 to read as
follows:

Sec.  52.2420  Identification of plan.

* * * * *
    (c) * * *

                                                     EPA-Approved Virginia Regulations and Statutes
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                        State  effective                                       Explanation [former SIP
          State citation                      Title/subject                   date                 EPA approval date                  citation]
--------------------------------------------------------------------------------------------------------------------------------------------------------

                                                                      * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
9 VAC 5,                                                                        State trading program budget
Chapter 140
--------------------------------------------------------------------------------------------------------------------------------------------------------
Part I                                                                           NOX Budget Trading Program
--------------------------------------------------------------------------------------------------------------------------------------------------------

                                                                      * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
Article 10                                                       State Trading Program Budget and Compliance Supplement Pool
--------------------------------------------------------------------------------------------------------------------------------------------------------
5-140-900.........................  State trading program budget.....  12/31/08..........  11/7/11 [Insert page number       Revise applicable year to
                                                                                where the document begins].       2004 and each year
                                                                                thereafter.

                                                                      * * * * * * *
5-140-920.........................  Total electric generating unit     12/31/08..........  11/7/11 [Insert page number       Add subsection B, which
                                     allocations.                                           where the document begins].       extends the NOX budget
                                                                                beyond 2008.
5-140-930.........................  Total non-electric generating      12/31/08..........  11/7/11 [Insert page number       Add subsection B, which
                                     unit allocations.                                      where the document begins].       extends the NOX budget
                                                                                beyond 2008.

                                                                      * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------

* * * * *
[FR Doc. 2011-28640 Filed 11-4-11; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 87, Number 203 (Friday, October 21, 2022)]
[Notices]
[Pages 64028-64029]
[FR Doc No: 2022-22918]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Numbers: RP22-472-000.
    Applicants: Interstate Gas Supply, Inc. Dominion Energy Solutions,
Inc.
    Description: Interstate Gas Supply, Inc. and Dominion Energy
Solutions, Inc. al. submits Fourth and Final Status Report.
    Filed Date: 10/14/22.
    Accession Number: 20221014-5195.
    Comment Date: 5 p.m. ET 10/26/22.

    Docket Numbers: RP23-24-000.
    Applicants: Tennessee Gas Pipeline Company, L.L.C.
    Description: Sec.  4(d) Rate Filing: PAL NRA Wells Fargo
Commodities, LLC SP380777 & SP380778 to be effective 11/1/2022.
    Filed Date: 10/14/22.
    Accession Number: 20221014-5032.
    Comment Date: 5 p.m.ET 10/26/22.

    Docket Numbers: RP23-25-000.
    Applicants: Texas Eastern Transmission, LP.
    Description: Compliance filing: TETLP October 2022 Penalty
Disbursement Report to be effective N/A.
    Filed Date: 10/14/22.
    Accession Number: 20221014-5141.
    Comment Date: 5 p.m. ET 10/26/22.

    Docket Numbers: RP23-26-000.
    Applicants: Rockies Express Pipeline LLC.
    Description: Sec.  4(d) Rate Filing: REX 2022-10-14 Negotiated Rate
Agreements Amendments to be effective 10/15/2022.
    Filed Date: 10/14/22.
    Accession Number: 20221014-5206.
    Comment Date: 5 p.m. ET 10/26/22.

    Docket Numbers: RP23-27-000.
    Applicants: Iroquois Gas Transmission System, L.P.
    Description: Sec.  4(d) Rate Filing: 10.17.22 Negotiated Rates--Ag
Energy Co-operative Ltd. R-8075-02 to be effective 11/1/2022.
    Filed Date: 10/17/22.
    Accession Number: 20221017-5026.
    Comment Date: 5 p.m. ET 10/31/22.

    Docket Numbers: RP23-28-000.
    Applicants: Iroquois Gas Transmission System, L.P.
    Description: Sec.  4(d) Rate Filing: 10.17.22 Negotiated Rates--
Macquarie Energy LLC R-4090-26 to be effective 11/1/2022.
    Filed Date: 10/17/22.
    Accession Number: 20221017-5027.
    Comment Date: 5 p.m. ET 10/31/22.

    Docket Numbers: RP23-29-000.
    Applicants: Iroquois Gas Transmission System, L.P.
    Description: Sec.  4(d) Rate Filing: 10.17.22 Negotiated Rates--
Freepoint Commodities LLC R-7250-44 to be effective 11/1/2022.
    Filed Date: 10/17/22.
    Accession Number: 20221017-5029.
    Comment Date: 5 p.m. ET 10/31/22.

    Docket Numbers: RP23-30-000.
    Applicants: Iroquois Gas Transmission System, L.P.
    Description: Sec.  4(d) Rate Filing: 10.17.22 Negotiated Rates--
Freepoint Commodities LLC R-7250-45 to be effective 11/1/2022.
    Filed Date: 10/17/22.
    Accession Number: 20221017-5035.
    Comment Date: 5 p.m. ET 10/31/22.

    Docket Numbers: RP23-31-000.
    Applicants: Iroquois Gas Transmission System, L.P.
    Description: Sec.  4(d) Rate Filing: 10.17.22 Negotiated Rates--
Uniper Global Commodities North America R-7650-05 to be effective 11/1/
2022.
    Filed Date: 10/17/22.
    Accession Number: 20221017-5038.

    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.

Filings in Existing Proceedings

    Docket Numbers: RP22-1056-001.
    Applicants: Enable Mississippi River Transmission, LLC.
    Description: Compliance filing: FERC Record ID Correction Filing to
be effective 8/19/2022.
    Filed Date: 10/17/22.
    Accession Number: 20221017-5059.
    Comment Date: 5 p.m. ET 10/31/22.

    Any person desiring to protest in any the above proceedings must
file in accordance with Rule 211 of the Commission's Regulations (18
CFR 385.211) on or before 5:00 p.m. Eastern time on the specified
comment date.
    The filings are accessible in the Commission's eLibrary system
(https://elibrary.ferc.gov/idmws/search/fercgensearch.asp) by querying
the docket number. eFiling is encouraged. More detailed information
relating to filing requirements, interventions, protests, service, and
qualifying facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call (866)
208-3676 (toll free). For TTY, call<PHONE_NUMBER>.

    Dated: October 17, 2022.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2022-22918 Filed 10-20-22; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 140 (Tuesday, July 22, 2014)]
[Notices]
[Page 42630]
[FR Doc No: 2014-17174]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket Number FRA-2014-0034]

Petition for Waiver of Compliance

    In accordance with Part 211 of Title 49 Code of Federal Regulations
(CFR), this document provides the public notice that by a letter dated
March 25, 2014, Norfolk Southern Railway (NS), petitioned the Federal
Railroad Administration (FRA) for a waiver of compliance from certain
provisions of the Federal railroad safety regulations contained at 49
CFR Part 232, Brake System Safety Standards for Freight and Other Non-
Passenger Trains and Equipment; End-of-Train Devices. FRA assigned the
petition Docket Number FRA-2014-0034.
    Specifically, NS seeks a waiver of compliance from 49 CFR 232.215,
Transfer train brake tests. This section states a transfer train, as
defined in 49 CFR 232.5, Definitions, shall receive a specified brake
test performed by a qualified person before proceeding. NS seeks
approval to perform a Class 3 brake test pursuant to 49 CFR 232.211(b)
on freight cars that are in switch service between the NS Decatur Yard
and Archer Daniels Midland's East Plant, West Plant, and New Yard
(collectively ``ADM'') facilities, in Decatur, IL, instead of the
specified transfer train brake test. The switch moves that are the
subject of this waiver request range from 0.2 miles to a maximum of 0.9
miles.
    NS states that performing the Class 3 brake test provides an
opportunity to verify the safe functioning of the brakes and also to
supplement the safety appliance inspection made upon arrival at the
yard inbound or during assembly of the move to ADM. An equivalent level
of safety is achieved through the performance of this test, as the rear
car's set and release confirms the functioning of the brake system. In
addition, the moves to ADM are 0.9 miles plus the length of the cut
making up the move. Of additional benefit is the elimination of
potentially burdensome delays due to blocked crossings and undue
congestion to the community at road crossings that could occur while
train crews perform a full transfer train brake test.
    A copy of the petition, as well as any written communications
concerning the petition, is available for review online at
www.regulations.gov and in person at the U.S. Department of
Transportation's Docket Operations Facility, 1200 New Jersey Avenue
SE., W12-140, Washington, DC 20590. The Docket Operations Facility is
open from 9 a.m. to 5 p.m., Monday through Friday, except Federal
Holidays.
    Interested parties are invited to participate in these proceedings
by submitting written views, data, or comments. FRA does not anticipate
scheduling a public hearing in connection with these proceedings since
the facts do not appear to warrant a hearing. If any interested party
desires an opportunity for oral comment, they should notify FRA, in
writing, before the end of the comment period and specify the basis for
their request.
    All communications concerning these proceedings should identify the
appropriate docket number and may be submitted by any of the following
methods:
     Web site: http://www.regulations.gov. Follow the online
instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: Docket Operations Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue SE., W12-140, Washington, DC
20590.
     Hand Delivery: 1200 New Jersey Avenue SE., Room W12-140,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal Holidays.
    Communications received by August 21, 2014 will be considered by
FRA before final action is taken. Comments received after that date
will be considered as far as practicable.
    Anyone is able to search the electronic form of any written
communications and comments received into any of our dockets by the
name of the individual submitting the comment (or signing the document,
if submitted on behalf of an association, business, labor union, etc.).
See http://www.regulations.gov/#!privacyNotice for the privacy notice
of regulations.gov or interested parties may review DOT's complete
Privacy Act Statement in the Federal Register published on April 11,
2000 (65 FR 19477).

    Issued in Washington, DC, on July 8, 2014.
Ron Hynes,
Director, Office of Safety Assurance and Compliance.
[FR Doc. 2014-17174 Filed 7-21-14; 8:45 am]
BILLING CODE 4910-06-P


[Federal Register Volume 87, Number 200 (Tuesday, October 18, 2022)]
[Notices]
[Page 63076]
[FR Doc No: 2022-22613]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-0736]

Gregory Settino: Final Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is issuing an order
under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently
debarring Gregory Settino from providing services in any capacity to a
person that has an approved or pending drug product application. FDA
bases this order on a finding that Mr. Settino was convicted of a
felony under Federal law for conduct that relates to the regulation of
any drug product under the FD&C Act. Mr. Settino was given notice of
the proposed permanent debarment and was given an opportunity to
request a hearing to show why he should not be debarred. As of August
15, 2022 (30 days after receipt of the notice), Mr. Settino had not
responded. Mr. Settino's failure to respond and request a hearing
within the prescribed timeframe constitutes a waiver of his right to a
hearing concerning this action.

DATES: This order is applicable October 18, 2022.

ADDRESSES: Submit applications for special termination of debarment to
the Dockets Management Staff, Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>, or at
https://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Jaime Espinosa, Division of
Enforcement (ELEM-4144), Office of Strategic Planning and Operational
Policy, Office of Regulatory Affairs, Food and Drug Administration,
12420 Parklawn Dr., Rockville, MD 20857,<PHONE_NUMBER>, or at
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Section 306(a)(2)(B) of the FD&C Act (21 U.S.C. 335a(a)(2)(B))
requires debarment of an individual from providing services in any
capacity to a person that has an approved or pending drug product
application if FDA finds that the individual has been convicted of a
felony under Federal law for conduct relating to the regulation of any
drug product under the FD&C Act. On April 20, 2022, Mr. Settino was
convicted, as defined in section 306(l)(1) of the FD&C Act, in the U.S.
District Court for the Eastern District of New York, when the court
accepted his plea of guilty and entered judgment against him for the
felony offense of theft of medical products in violation of 18 U.S.C.
670.
    As described in the indictment in his case, filed on September 20,
2020, from approximately 2012 to January 2020, Mr. Settino was the
production supervisor of manufacturing for Luitpold Pharmaceuticals,
Inc. (Luitpold), which was renamed American Regent, Inc. (American
Regent) in January 2019. Luitpold and American Regent manufactured an
injectable equine drug called ADEQUAN, which is administered to horses
with degenerative joint disease. In his capacity as a production
supervisor, Mr. Settino supervised the manufacture of pre-retail
medical products including ADEQUAN. From approximately 2012 to January
2020, Mr. Settino stole thousands of bottles of ADEQUAN from Luitpold
and American Regent and then sold the stolen ADEQUAN for a total of
more than $600,000. As contained in the sentencing memoranda from his
case, filed on March 31, 2022, and April 19, 2022, Mr. Settino resold
the stolen drugs, many of which were expired, to horse trainers and
veterinarians at New York area racetracks.
    Based on this conviction, FDA sent Mr. Settino by certified mail on
July 11, 2022, a notice proposing to permanently debar him from
providing services in any capacity to a person that has an approved or
pending drug product application. The proposal was based on a finding,
under section 306(a)(2)(B) of the FD&C Act, that Mr. Settino was
convicted, as set forth in section 306(l)(1) of the FD&C Act, of a
felony under Federal law for conduct relating to the regulation of any
drug product under the FD&C Act. The proposal also offered Mr. Settino
an opportunity to request a hearing, providing him 30 days from the
date of receipt of the letter in which to file the request, and advised
him that failure to request a hearing constituted an election not to
use the opportunity for a hearing and a waiver of any contentions
concerning this action. Mr. Settino received the proposal on July 15,
2022. He did not request a hearing within the timeframe prescribed by
regulation and has, therefore, waived his opportunity for a hearing and
any contentions concerning his debarment (21 CFR part 12).

II. Findings and Order

    Therefore, the Assistant Commissioner, Office of Human and Animal
Food Operations, under section 306(a)(2)(B) of the FD&C Act, under
authority delegated to the Assistant Commissioner, finds that Mr.
Settino has been convicted of a felony under Federal law for conduct
relating to the regulation of any drug product under the FD&C Act.
    As a result of the foregoing finding, Mr. Settino is permanently
debarred from providing services in any capacity to a person with an
approved or pending drug product application, applicable (see DATES)
(see section 306(a)(2)(B) and 306(c)(2)(A)(ii) of the FD&C Act). Any
person with an approved or pending drug product application who
knowingly employs or retains as a consultant or contractor, or
otherwise uses in any capacity the services of Mr. Settino during his
debarment, will be subject to civil money penalties (section 307(a)(6)
of the FD&C Act (21 U.S.C. 335b(a)(6))). If Mr. Settino provides
services in any capacity to a person with an approved or pending drug
product application during his period of debarment, he will be subject
to civil money penalties (section 307(a)(7) of the FD&C Act). In
addition, FDA will not accept or review any abbreviated new drug
application from Mr. Settino during his period of debarment, other than
in connection with an audit under section 306 of the FD&C Act (section
306(c)(1)(B) of the FD&C Act). Note that, for purposes of sections 306
and 307 of the FD&C Act, a ``drug product'' is defined as a ``drug
subject to regulation under section 505, 512, or 802 of this Act (21
U.S.C. 355, 360b, 382) or under section 351 of the Public Health
Service Act (42 U.S.C. 262)'' (section 201(dd) of the FD&C Act (21
U.S.C. 321(dd))).
    Any application by Mr. Settino for special termination of debarment
under section 306(d)(4) of the FD&C Act should be identified with
Docket No. FDA-2022-N-0736 and sent to the Dockets Management Staff
(see ADDRESSES). The public availability of information in these
submissions is governed by 21 CFR 10.20.
    Publicly available submissions will be placed in the docket and
will be viewable at https://www.regulations.gov or at the Dockets
Management Staff (see ADDRESSES) between 9 a.m. and 4 p.m., Monday
through Friday,<PHONE_NUMBER>.

    Dated: October 13, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-22613 Filed 10-17-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 80, Number 228 (Friday, November 27, 2015)]
[Notices]
[Page 74212]
[FR Doc No: 2015-29956]

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DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

Hazardous Materials: Notice of Application for Special Permits

AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA),
DOT.

ACTION: List of applications for special permits

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

SUMMARY: In accordance with the procedures governing the application
for, and the processing of, special permits from the Department of
Transportation's Hazardous Material Regulations (49 CFR part 107,
subpart B), notice is hereby given that the Office of Hazardous
Materials Safety has received the application described herein. Each
mode of transportation for which a particular special permit is
requested is indicated by a number in the ``Nature of Application''
portion of the table below as follows: 1--Motor vehicle, 2--Rail
freight, 3--Cargo vessel, 4--Cargo aircraft only, 5--Passenger-carrying
aircraft.

DATES: Comments must be received on or before December 28, 2015.

ADDRESSES: Send comments to Record Center, Pipeline and Hazardous
Materials Safety Administration, U.S. Department of Transportation,
Washington, DC 20590.
    Comments should refer to the application number and be submitted in
triplicate. If confirmation of receipt of comments is desired, include
a self-addressed stamped postcard showing the special permit number.

FOR FURTHER INFORMATION CONTACT: Ryan Paquet, Director, Office of
Hazardous Materials Approvals and Permits Division, Pipeline and
Hazardous Materials Safety Administration, U.S. Department of
Transportation, East Building, PHH-30, 1200 New Jersey Avenue
Southeast, Washington, DC 20590-0001,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Copies of the applications are available for
inspection in the Records Center, East Building, PHH-30, 1200 New
Jersey Avenue Southeast, Washington, DC or at http://regulations.gov.
    This notice of receipt of applications for special permit is
published in accordance with part 107 of the Federal hazardous
materials transportation law (49 U.S.C. 5117(b); 49 CFR 1.53(b)).

    Issued in Washington, DC, on November 4, 2015.
Donald Burger,
Chief, General Approvals and Permits.

----------------------------------------------------------------------------------------------------------------
                                                                     Regulation(s)
    Application No.        Docket No.           Applicant              affected         Nature of permit thereof
----------------------------------------------------------------------------------------------------------------
                                               NEW SPECIAL PERMITS
----------------------------------------------------------------------------------------------------------------
16591-N...............  ................  Department of          49 CFR 171.3(a),      To authorize the
                                           Defense, Scott AFB,    173.302a, ICAO TI     transportation in
                                           IL.                    Packing Instruction   commerce of compressed
                                                                  200, IMDG Code        argon in non-DOT
                                                                  Packing Instruction   specification cylinders.
                                                                  P200.                 (modes 1, 3, 4).
16592-N...............  ................  Stericycle Specialty   49 CFR Subparts A     To authorize the
                                           Waste Solutions,       through E of Part     transportation in
                                           Inc., Minneapolis,     173.                  commerce of certain Drug
                                           MN.                                          Enforcement
                                                                                Administration (DEA)
                                                                                controlled substances
                                                                                transported for the
                                                                                purpose of disposal.
                                                                                (mode 1).
16596-N...............  ................  Great Slave            49 CFR 172.101        To authorize
                                           Helicopters, Ltd.,     Hazardous Materials   transportation in
                                           Yellowknife, Canada,   Table Column (9B),    commerce in the U.S.
                                           NT.                    Subpart C of Part     only of certain
                                                                  172, 172.301(c),      hazardous materials by
                                                                  175.30, Part 173.     Rotorcraft External Load
                                                                                Operations transporting
                                                                                hazardous materials
                                                                                attached to or suspended
                                                                                from an aircraft without
                                                                                being subject to certain
                                                                                hazard communication
                                                                                requirements, quantity
                                                                                limitations, packaging
                                                                                and loading and storage
                                                                                requirements. (mode 4).
16598-N...............  ................  Spaceflights, Inc.,    49 CFR 173.24(b)(1),  To authorize the
                                           Tukwila, WA.           173.304a,             transportation in
                                                                  173.185(a)(1).        commerce of the SHERPA
                                                                                spacecraft containing
                                                                                non-DOT specification
                                                                                cylinders filled with a
                                                                                Division 2.1 gas and
                                                                                three lithium ion
                                                                                batteries contained in
                                                                                equipment that are not
                                                                                of a type proven to meet
                                                                                the criteria in Part
                                                                                III, sub-section 38.3 of
                                                                                the UN Manual of Tests
                                                                                and Criteria. (mode 1).
16601-N...............  ................  SAFC Hitech, Inc.,     49 CFR 173.181(b),    To authorize the
                                           Haverhill, MA.         IMDG Code Packing     manufacture, mark, sale
                                                                  Instruction P400,     and use of specially-
                                                                  paragraph (2).        designed combination
                                                                                packagings for the
                                                                                transportation in
                                                                                commerce of certain
                                                                                pyrophoric hazardous
                                                                                materials. (modes 1, 3).
16602-N...............  ................  Hydrite Chemical Co.,  49 CFR 173.158(b),    To authorize the
                                           Brookfield, WI.        173.158(e),           transportation in
                                                                  173.158(f).           commerce of nitric acid
                                                                                with a concentration up
                                                                                to 50% in UN 3H1
                                                                                jerricans and UN 1H1
                                                                                plastic drums. (mode 1).
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2015-29956 Filed 11-25-15; 8:45 am]
 BILLING CODE 4909-60-M


ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2008-0705; FRL-____-_    ]

 Approval and Promulgation of Implementation Plans; Nevada; Vehicle
Inspection and Maintenance Program

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

SUMMARY: Under the Clean Air Act, EPA is proposing to approve certain
revisions, and to disapprove certain other revisions, of the Nevada
State Implementation Plan submitted by the Nevada Division of
Environmental Protection. These revisions relate to the application of
the State’s vehicle inspection and maintenance program to vehicles
operated on Federal installations. EPA is also proposing to correct
certain plan revisions related to this subject that EPA previously
approved in error. The intended effect is to ensure that vehicles
operated on Federal installations are subject only to those requirements
of the State’s vehicle inspection and maintenance program that apply
in the same manner and to the same extent to nongovernmental entities.

DATE: Any comments must arrive by [Insert date 30 days from the date of
publication in the Federal Register].

ADDRESSES: Submit comments, identified by docket number
EPA-R09-OAR-2008-0705, by one of the following methods:

Federal eRulemaking Portal:   HYPERLINK "http://www.regulations.gov"
www.regulations.gov .  Follow the on-line instructions.

E-mail<EMAIL_ADDRESS>GOTOBUTTON BM_3_  .

Mail or deliver: Eleanor Kaplan (AIR-2), U.S. Environmental Protection
Agency Region IX, 75 Hawthorne Street, San Francisco, CA 94105.

Instructions: All comments will be included in the public docket without
change and may be made available online at   HYPERLINK
"http://www.regulations.gov"  www.regulations.gov , including any
personal information provided, unless the comment includes Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Information that you consider CBI or otherwise
protected should be clearly identified as such and should not be
submitted through   HYPERLINK "http://www.regulations.gov"
www.regulations.gov  or e-mail.   HYPERLINK "http://www.regulations.gov"
 www.regulations.gov  is an “anonymous access” system, and EPA will
not know your identity or contact information unless you provide it in
the body of your comment. If you send e-mail directly to EPA, your
e-mail address will be automatically captured and included as part of
the public comment. If EPA cannot read your comment due to technical
difficulties and cannot contact you for clarification, EPA may not be
able to consider your comment.

Docket: The index to the docket for this action is available
electronically at   HYPERLINK "http://www.regulations.gov"
www.regulations.gov  and in hard copy at EPA Region IX, 75 Hawthorne
Street, San Francisco, California. While all documents in the docket are
listed in the index, some information may be publicly available only at
the hard copy location (e.g., copyrighted material), and some may not be
publicly available in either location (e.g., CBI). To inspect the hard
copy materials, please schedule an appointment during normal business
hours with the contact listed in the FOR FURTHER INFORMATION CONTACT
section below.

FOR FURTHER INFORMATION CONTACT:  Eleanor Kaplan, Air Planning Office
(AIR-2), U.S. Environmental Protection Agency, Region IX, (415)
947-4147,   HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>.

SUPPLEMENTARY INFORMATION: Throughout this document, “we,” “us”
and “our” refer to EPA.

Table of Contents

I. Background

II. The State’s SIP Revision Submittal

A. What revisions did the State submit?

B. What is our evaluation of the revisions?

III. Correction of Previously-Approved Provisions

A. What provisions did we previously approve?

B. What is our evaluation of the approved provisions?

IV. Public Comment and Final Action

V. Statutory and Executive Order Reviews

I. Background

On January 7, 2008 (73 FR 1175), EPA proposed, under the Clean Air Act
(CAA or “Act”), to approve certain submittals by the Nevada Division
of Environmental Protection (NDEP) of revisions to the Nevada state
implementation plan (SIP). The submittals that were the subject of our
January 7, 2008 proposed rule primarily relate to attainment and
maintenance of the carbon monoxide (CO) national ambient air quality
standard (NAAQS) in the Truckee Meadows nonattainment area. In our
January 7, 2008 proposed rule, we also proposed to approve the State’s
submittal of an update to the regulatory element of the State’s mobile
source SIP, including statutory provisions and rules related to the
State’s vehicle inspection and maintenance (I/M) programs administered
in Truckee Meadows (located within Washoe County) and Las Vegas Valley
and Boulder City (located within Clark County).

As part of our January 7, 2008 proposed rule, we proposed to approve all
of the State’s vehicle I/M rules with the exception of a particular
subsection (subsection (2)) of a single rule, Nevada Administrative Code
(NAC) section 445B.595 (“Inspections of vehicles owned by State or
political subdivisions or operated on federal installations”) (“NAC
445B.595(2)”), for which we proposed neither approval nor disapproval.
We explained our “no action” proposal for NAC 445B.595(2) as
follows:

“The Federal I/M rule requires that vehicles operated on Federal
installations located within an I/M program area be tested regardless of
whether the vehicles are registered in the state or local I/M area. See
40 CFR 51.356(a)(4). However, we are not requiring states to implement
40 CFR 51.356(a)(4) at this time. The Department of Justice has
recommended to EPA that this Federal regulation be revised since it
appears to grant states authority to regulate Federal installations in
circumstances where the Federal government has not waived sovereign
immunity. It would not be appropriate to require compliance with this
regulation if it is not constitutionally authorized. EPA will be
revising this provision in the future and will review state I/M SIPs
with respect to this issue when this new rule is final. Therefore, for
these reasons, EPA is neither approving nor disapproving the specific
requirements which apply to Federal facilities at this time.
Specifically, we are taking no action on submitted rule NAC 445B.595(2),
which extends the State’s I/M requirements to motor vehicles operated
on Federal installations located within I/M areas.”

See 73 FR 1175, at 1182. See also 73 FR 1175, at 1176 and 1194 for
summaries of our proposed action in this regard. The recommendation by
the Department of Justice (DOJ) referred to in the above excerpt was
made in a letter from Lois J. Schiffer, Assistant Attorney General, DOJ
Environment and Natural Resources Division, to Scott Fulton, Acting
General Counsel, EPA, dated July 29, 1998.

In our January 7, 2008 proposed rule, we also proposed, under CAA
section 110(k)(6), to rescind our previous approval of an earlier
codification of NAC 445B.595(2), once again, based on sovereign immunity
concerns. We had approved the earlier codification of NAC 445B.595(2) in
connection with our approval of the State’s vehicle I/M program as
administered in Las Vegas Valley and Boulder City. See 69 FR 56351, at
56354 (September 21, 2004).

Our January 7, 2008 proposed rule provided for a 30-day public comment
period, and we received comments related to our proposal from NDEP
concerned about our proposed error correction related to NAC
445B.595(2). On July 3, 2008, we took final action on all aspects of the
January 7, 2008 proposed rule with the exception of our proposed action
on NAC 445B.595(2) for which we agreed to reconsider action in a future
proposed rule. See 73 FR 38124 (July 3, 2008). We have now reconsidered
the issue of sovereign immunity in relation to the State’s vehicle I/M
program and propose, in today’s action, to approve paragraphs (a), (b)
and (c) of NAC 445B.595(2) (“NAC 445B.595(2)(a), (b), and (c)”), to
disapprove paragraph (d) of NAC 445B.595(2) (“NAC 445B.595(2)(d)”),
to rescind our previous approval of NAC 445B.595(2)(d) and our previous
approvals of another State vehicle I/M requirement, NAC 445B.461(3)(d).

II. The State’s SIP Revision Submittal

A. What revisions did the State submit?

On May 11, 2007, NDEP submitted, among other provisions, rules
implementing the State’s vehicle I/M program in Truckee Meadows and
Las Vegas Valley/Boulder City. Among the rules are NAC 445B.461
(“Compliance by Federal Government, state agencies and political
subdivisions”) and NAC 445B.595 (“Inspections of vehicles owned by
State or political subdivisions or operated on federal
installations”). NAC 445B.461 provides in relevant part:

“1. A license may be issued to the Federal Government ... to inspect
motor vehicles ... for the purpose of compliance with NAC 445B.400 to
445B.735, inclusive.

2. ... .

3. The holder of a license issued pursuant to subsection 1 is exempt
from the requirements set forth in the following sections for the
limited purposes indicated: (a) Bond, NAC 445B.465; (b) Evidence of
compliance, NAC 445B.583 to 445B.586, inclusive; (c) Sign, NAC 445B.469;
and (d) Use of waiver, NAC 445B.590.”

NAC 445B.595 provides in relevant part:

“1. ... .

2. Motor vehicles operated on federal installations located within an
area requiring a program for the inspection of exhaust emissions must be
inspected and certified annually. The provisions of this subsection:

(a) 	Apply to all motor vehicles which are owned, leased or operated by
an employee of, or military personnel stationed at, a federal
installation;

(b) 	Apply to all motor vehicles which are owned, leased or operated by
any agency of the Federal Government on a federal installation;

(c) 	Do not apply to tactical military vehicles operated on a federal
installation; and

(d) 	Do not apply to motor vehicles which are owned, leased or operated
on a federal installation by visiting federal employees or military
personnel when the visit does not exceed 60 days within any 1 calendar
year. A federal installation shall annually submit to the Department
evidence showing that it has complied with the provisions of this
paragraph, in a form prescribed by the Department.”

We approved NAC 445B.461 in 2004 in connection with our approval of the
State’s I/M program in Las Vegas Valley and Boulder City (see 69 FR
56351, at 56354 (September 21, 2004)), and again on July 3, 2008 in
connection with our final approval of the State’s update (submitted on
May 11, 2007) to the regulatory element of the State’s mobile source
SIP, including the rules for the State’s vehicle I/M program in
Truckee Meadows and Las Vegas Valley/Boulder City. We also approved NAC
445B.595 in connection with our approval of the State’s I/M program in
Las Vegas Valley and Boulder City but, as noted above, proposed to
rescind our previous approval of NAC 445B.595(2) in our January 7, 2008
proposed rule, and have as yet taken no action on NAC 445B.595(2) as
submitted to us on May 11, 2007. The versions of NAC 445B.461 and NAC
445B.595 approved by us in 2004 and those submitted to us on May 11,
2007 are identical.

B. What is our evaluation of the revisions?

CAA section 118(a) requires that each agency and employee of the Federal
government comply with all Federal, State, interstate, and local
requirements, administrative authority, and process and sanctions
respecting the control and abatement of air pollution in the same
manner, and to the same extent as any nongovernmental entity. In our
evaluation of the State’s I/M program as it relates to Federal
installations, we also rely upon EPA’s guidance document, “Interim
Guidance for Federal Facility Compliance with Clean Air Act Sections
118(c) and 118(d) and Applicable Provisions of State Vehicle Inspection
and Maintenance Programs,” Draft, December 1999.

Generally, the State of Nevada has made the State’s mobile source
rules, including many such rules related to the vehicle I/M program,
applicable to Federal installations by including the Federal Government
in the State’s rule defining “person” for the purposes of the
State’s mobile source regulations. See NAC 445B.443. With respect to
specific testing, standards, and certification requirements, the State
has made the vehicle I/M program applicable to the Federal Government
through adoption of NAC 445B.595(2)(including paragraphs (a) through
(d)), which is set forth above. Through NAC 445B.595(2), the same types
of emission tests and the same emissions standards apply to the motor
vehicles owned by the Federal Government as apply to motor vehicles
owned by nongovernmental entities. Thus, with the exception of the two
specific provisions discussed below, we find that the State’s I/M
program complies with CAA section 118(a) and must be complied with by
Federal installations and employees. We therefore propose to approve NAC
4454B.595(2)(a), (b), and (c), as submitted by NDEP on May 11, 2007.

Under the State’s vehicle I/M program, there are only two significant
requirements that apply to Federal installations and employees that do
not also apply in the same manner, and to the same extent to
nongovernmental entities. These requirements are found in NAC
445B.595(2)(d) and NAC 445B.461(3)(d). NAC 445B.595(2)(d) requires I/M
testing and certification for non-resident Federal employees whose
visits to Federal installations in I/M areas exceed 60 days. No such
requirement under the State’s vehicle I/M program applies to
nonresident visitors who are not Federal employees. Likewise, NAC
445B.461(3)(d) disqualifies the Federal Government from eligibility for
a waiver that nongovernmental entities, under the same circumstances,
are eligible. Waivers are generally allowed under the I/M program for
vehicles that cannot pass the emissions test but for which qualifying
repairs costing over certain thresholds have been made. Both provisions
discriminate against Federal installations or employees relative to the
requirements for nongovernmental entities and thus are inconsistent with
the limits on the waiver of sovereign immunity established in CAA
section 118(a).

Therefore, we propose to approve NDEP’s submittal on May 11, 2007 of
NAC 445B.595(2)(a), (b), and (c) but to disapprove paragraph (d) of the
same subsection. We recently approved NDEP’s submittal on May 11, 2007
of NAC 445B.461 and address NAC 445B.461(3)(d) in the following section
of this document.

III. Correction of Previously-Approved Provisions

A. What provisions did we previously approve?

We approved NAC 445B.461, including NAC 445B.461(3)(d), and NAC
445B.595, including NAC 445B.595(2)(d), in connection with our 2004
approval of the State’s vehicle I/M program in Las Vegas Valley and
Boulder City. Moreover, we approved NAC 445B.461 again in our July 3,
2008 final rule.

B. What is our evaluation of the approved provisions?

Section 110(k)(6) of the Clean Air Act, as amended in 1990, provides,
“Whenever the Administrator determines that the Administrator’s
action approving, disapproving, or promulgating any plan or plan
revision (or part thereof), area designation, redesignation,
classification or reclassification was in error, the Administrator may
in the same manner as the approval, disapproval, or promulgation revise
such action as appropriate without requiring any further submission from
the State. Such determination and the basis thereof shall be provided to
the State and the public.”

We interpret this provision to authorize the Agency to make corrections
to a promulgated regulation when it is shown to our satisfaction that
(1) we clearly erred in failing to consider or in inappropriately
considering information made available to EPA at the time of the
promulgation, or the information made available at the time of
promulgation is subsequently demonstrated to have been clearly
inadequate, and (2) other information persuasively supports a change in
the regulation. See 57 FR 56762, at 56763 (November 30, 1992).

In this instance, we have found clear error in our 2004 approval of NAC
445B.461(3)(d) and NAC 445B.595(2)(d), and our subsequent 2008 approval
of NAC 445B.461(3)(d), as a part of the Nevada SIP because at the time
of our 2004 and 2008 actions such discriminatory provisions were not
authorized under CAA section 118(a). Moreover, since such provisions
remain unauthorized under CAA section 118(a), we believe that an error
correction action under CAA section 110(k)(6) under these circumstances
is appropriate. Therefore, we propose to rescind our previous approvals
of NAC 445B.461(3)(d) and NAC 445B.595(2)(d) since they would otherwise
set forth additional requirements under the I/M program for Federal
installations and employees that do not apply to nongovernmental
entities and thus would be inconsistent with the limits of sovereign
immunity established in CAA section 118(a).

IV. Public Comment and Final Action

Under section 110(k)(3) of the Clean Air Act, we propose to approve
NDEP’s submittal on May 11, 2007 of NAC 445B.595(2)(a), (b), and (c)
as consistent with all applicable CAA requirements but to disapprove NAC
445B.595(2)(d) as inconsistent with the limits on sovereign immunity
established in CAA section 118(a). In addition, under CAA section
110(k)(6), we propose to rescind our previous approvals of NAC
445B.461(3)(d) and 445B.595(2)(d) since they would otherwise set forth
additional requirements under the I/M program for Federal installations
and employees that do not apply to nongovernmental entities and thus
would be inconsistent with CAA section 118(a).

EPA is soliciting public comments on the issues discussed in this
document and will accept comments for the next 30 days. These comments
will be considered before taking final action.

V. Statutory and Executive Order Reviews

Under the Clean Air Act, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA’s role is to approve state choices,
provided that they meet the criteria of the Clean Air Act. Accordingly,
this action merely proposes to approve state law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by state law. For that reason, this proposed action:

•	is not a "significant regulatory action" subject to review by the
Office of Management and Budget under Executive Order 12866 (58 FR
51735, October 4, 1993);

•	does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);

•	is certified as not having a significant economic impact on a
substantial number of small entities under the Regulatory Flexibility
Act (5 U.S.C. 601 et seq.);

•	does not contain any unfunded mandate or significantly or uniquely
affect small governments, as described in the Unfunded Mandates Reform
Act of 1995 (Public Law 104-4);

•	does not have Federalism implications as specified in Executive
Order 13132 (64 FR 43255, August 10, 1999);

•	is not an economically significant regulatory action based on health
or safety risks subject to Executive Order 13045 (62 FR 19885, April 23,
1997);

•	is not a significant regulatory action subject to Executive Order
13211 (66 FR 28355, May 22, 2001);

•	is not subject to requirements of Section 12(d) of the National
Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note)
because application of those requirements would be inconsistent with the
Clean Air Act; and

•	does not provide EPA with the discretionary authority to address, as
appropriate, disproportionate human health or environmental effects,
using practicable and legally permissible methods, under Executive Order
12898 (59 FR 7629, February 16, 1994).

In addition, this proposed rule does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian country located in
the state, and EPA notes that it will not impose substantial direct
costs on tribal governments or preempt tribal law.

List of Subjects in 40 CFR Part 52

	Environmental protection, Air pollution control, Intergovernmental
relations, Reporting and recordkeeping requirements.

_September 15, 2008	     	________________________

Dated:					Laura Yoshii

Acting Regional Administrator,

Region IX.

  Under NAC 445B.443, “Person” includes the Federal Government, the
State of Nevada, or any of its political subdivisions and any other
administrative agency, public or quasi-public corporation, or other
legal entity. NDEP and the Nevada Department of Motor Vehicles (DMV)
interpret NAC 445B.443 in light of the “basic” definition of the
term “person” as codified at NRS 0.039: “Except as otherwise
expressly provided in a particular statute or required by the context,
“person” means a natural person, any form of business or social
organization and any other nongovernmental legal entity including, but
not limited to, a corporation, partnership, association, trust or
unincorporated organization. The term does not include a government,
governmental agency or political subdivision of a government.” EPA
approved NRS 0.039 into the Nevada SIP in 2006. See 71 FR 51766 (August
31, 2006). To clarify that NAC 445B.443 builds upon the “basic”
definition of person, we understand that NDEP and Nevada DMV intend to
amend NAC 445B.443 to include a specific reference to NRS 0.039.

  We have discussed this issue with NDEP and Nevada DMV, and on April
30, 2008, NDEP submitted a letter to EPA expressing its agreement that
the subject provisions are not consistent with CAA section 118(a) and
its support for EPA’s proposal to remove the provisions from the
Nevada SIP. See letter from Michael Elges, Chief, NDEP Bureau of Air
Quality Planning, to Jeff Wehling, Office of Regional Counsel, EPA
Region IX, dated April 30, 2008.

 PAGE

 PAGE   15


[Federal Register Volume 86, Number 110 (Thursday, June 10, 2021)]
[Notices]
[Page 30960]
[FR Doc No: 2021-12198]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-0315]

Electronic Study Data Submission; Data Standards; Support and
Requirement Begin for Study Data Tabulation Model Version 1.8 With
Standard for Exchange of Nonclinical Data Implementation Guide--Animal
Rule Version 1.0; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; correction.

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SUMMARY: The Food and Drug Administration (FDA) is correcting a
document that appeared in the Federal Register on March 11, 2020. The
document announced that FDA will begin supporting the Clinical Data
Interchange Standards Consortium (CDISC) for Study Data Tabulation
Model version 1.8 (SDTM v1.8), and CDISC Standard for Exchange of
Nonclinical Data Implementation Guide--Animal Rule version 1.0 (SENDIG-
AR v1.0) on March 15, 2020, and that these new standards will be
required in submissions to FDA effective March 15, 2022. The document
omitted the 36-month implementation period for certain investigational
new drugs applications (INDs) as required by the guidance for industry
entitled ``Providing Regulatory Submissions in Electronic Format--
Standardized Study Data'' which is referenced in that document. This
document corrects that error.

FOR FURTHER INFORMATION CONTACT: Chenoa Conley, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1117, Silver Spring, MD 20993-0002, 301-
796-0035, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Correction

    In the Federal Register of March 11, 2020 (85 FR 14205), in FR Doc.
2020-04898, the following corrections are made:
    1. On page 14205, in the second column, the first sentence of the
SUMMARY is corrected to read: ``The Food and Drug Administration (FDA
or Agency) Center for Drug Evaluation and Research (CDER) is announcing
that FDA will begin supporting the Clinical Data Interchange Standards
Consortium (CDISC) for Study Data Tabulation Model version 1.8 (SDTM
v1.8), and CDISC Standard for Exchange of Nonclinical Data
Implementation Guide--Animal Rule version 1.0 (SENDIG-AR v1.0) on March
15, 2020, and that these new standards will be required in submissions
for studies that start after March 15, 2022 (for new drug applications
(NDAs), abbreviated new drug applications (ANDAs), and biologics
license applications (BLAs)), and in submissions for studies that start
after March 15, 2023 (for certain investigational new drug applications
(INDs)), that are submitted to CDER.''
    2. On page 14206, in the first column, the last sentence of the
document is corrected to read as follows: ``FDA will begin supporting
SDTM v1.8 and SENDIG-AR v1.0 on March 15, 2020, and the use of these
new standards will be required in Animal Rule \1\ submissions for
studies that start after March 15, 2022 (for NDAs, ANDAs, and BLAs),
and in Animal Rule submissions for studies that start after March 15,
2023 (for certain INDs), that are submitted to CDER.''
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    \1\ The Animal Rule refers to FDA's regulations for the approval
of new drugs and biological products when human efficacy studies are
not ethical or feasible (see 21 CFR 314.600-650 for drugs and 21 CFR
601.90-95 for biologics).

    Dated: June 4, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-12198 Filed 6-9-21; 8:45 am]
BILLING CODE 4164-01-P