[Federal Register Volume 86, Number 90 (Wednesday, May 12, 2021)]
[Notices]
[Pages 26048-26050]
[FR Doc No: 2021-10017]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-5138]

S5(R3) Detection of Reproductive and Developmental Toxicity for
Human Pharmaceuticals; International Council for Harmonisation;
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry entitled ``S5(R3)
Detection of Reproductive and Developmental Toxicity for Human
Pharmaceuticals.'' The guidance was prepared under the auspices of the
International Council for Harmonisation of Technical Requirements for
Pharmaceuticals for Human Use (ICH), formerly the International
Conference on Harmonisation of Technical Requirements for Registration
of Pharmaceuticals for Human Use. The guidance provides key
considerations for developing a testing strategy to identify hazard and
characterize reproductive risk for human pharmaceuticals. The guidance
is intended to align with other ICH guidances, elaborate on concepts to

consider when designing studies, and identify potential circumstances
in which a risk assessment can be made based on preliminary studies. It
also clarifies the qualification and potential use of alternative
assays. This guidance finalizes the draft guidance issued on November
13, 2017.

DATES: The announcement of the guidance is published in the Federal
Register on May 12, 2021.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2017-D-5138 for ``S5(R3) Detection of Reproductive and
Developmental Toxicity for Human Pharmaceuticals.'' Received comments
will be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002, or the Office of
Communication, Outreach and Development, Center for Biologics
Evaluation and Research (CBER), Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. The guidance may also be obtained by mail by calling
CBER at 1-800-835-4709 or<PHONE_NUMBER>. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Regarding the guidance: Ronald Wange,
Center for Drug Evaluation and Research, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 22, Rm. 3342, Silver Spring, MD 20993-
0002,<PHONE_NUMBER>; or Stephen Ripley, Center for Biologics Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.
    Regarding the ICH: Jill Adleberg, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6364, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``S5(R3) Detection of Reproductive and Developmental Toxicity
for Human Pharmaceuticals.'' The guidance was prepared under the
auspices of ICH. ICH has the mission of achieving greater regulatory
harmonization worldwide to ensure that safe, effective, high-quality
medicines are developed, registered, and maintained in the most
resource-efficient manner.
    By harmonizing the regulatory requirements in regions around the
world, ICH guidelines have substantially reduced duplicative clinical
studies, prevented unnecessary animal studies, standardized the
reporting of important safety information, standardized marketing
application submissions, and made many other improvements in the
quality of global drug development and manufacturing and the products
available to patients.
    The six Founding Members of the ICH are FDA; the Pharmaceutical
Research and Manufacturers of America; the European Commission; the
European Federation of Pharmaceutical Industries Associations; the
Japanese Ministry of Health, Labour, and Welfare; and the Japanese
Pharmaceutical Manufacturers Association. The Standing Members of the
ICH Association include Health

Canada and Swissmedic. Additionally, the Membership of ICH has expanded
to include other regulatory authorities and industry associations from
around the world (refer to https://www.ich.org/).
    ICH works by involving technical experts from both regulators and
industry parties in detailed technical harmonization work and the
application of a science-based approach to harmonization through a
consensus-driven process that results in the development of ICH
guidelines. The regulators around the world are committed to
consistently adopting these consensus-based guidelines, realizing the
benefits for patients and for industry.
    As a Founding Regulatory Member of ICH, FDA plays a major role in
the development of each of the ICH guidelines, which FDA then adopts
and issues as guidance for industry. FDA's guidance documents do not
establish legally enforceable responsibilities. Instead, they describe
the Agency's current thinking on a topic and should be viewed only as
recommendations, unless specific regulatory or statutory requirements
are cited.
    In the Federal Register of November 13, 2017 (82 FR 52306), FDA
published a notice announcing the availability of a draft guidance
entitled ``S5(R3) Detection of Toxicity to Reproduction for Human
Pharmaceuticals.'' The notice gave interested persons an opportunity to
submit comments by February 12, 2018.
    After consideration of the comments received and revisions to the
guideline, a final draft of the guideline was submitted to the ICH
Assembly and endorsed by the regulatory agency members in January 2020.
    The guidance finalizes the guidance issued on November 13, 2017.
The guidance has undergone revisions to align with other ICH guidances,
elaborate on concepts to consider when designing studies, and identify
potential circumstances in which a risk assessment can be made based on
preliminary studies. It also clarifies the qualification and potential
use of alternative assays.
    The purpose of this guidance is to provide key considerations for
developing a testing strategy to identify hazard and characterize
reproductive risk for human pharmaceuticals. The guidance informs on
the use of existing data and identifies potential study designs to
supplement available data to identify, assess, and convey risk. General
concepts and recommendations are provided that should be considered
when interpreting study data and assessing reproductive risk in support
of clinical development and marketing approval.
    This guidance applies to pharmaceuticals, including biotechnology-
derived pharmaceuticals; vaccines (and their novel constitutive
ingredients) for infectious diseases; and novel excipients that are
part of the final pharmaceutical product. It does not apply to cellular
therapies, gene therapies, and tissue-engineered products. The
methodological principles (e.g., study design, dose selection, and
species selection) outlined in this guidance can also apply to all
compounds for which the conduct of reproductive and/or developmental
toxicity studies is appropriate, including vaccines for other
indications (e.g., cancer). (see ICH guidance for industry ``S9
Nonclinical Evaluation for Anticancer Pharmaceuticals'' (March 2010),
available at https://www.fda.gov/media/73161/download).
    The guidance reflects revisions made in response to comments
received on the draft guidance. These include reorganization of the
guidance to improve readability and clarity, to introduce discussion of
conventional assessment strategies earlier in the document, and to
clarify which elements of the guidance are more appropriate for
biotechnology-derived therapies. To accommodate the rapidly evolving
nature of alternative assay development, the discussion of alternative
assays was placed in an Annex, subject to a maintenance procedure, to
allow for more frequent updating of this material.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``S5(R3) Detection of Reproductive and
Developmental Toxicity for Human Pharmaceuticals.'' It does not
establish any rights for any person and is not binding on FDA or the
public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    This guidance contains no collection of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required.
    However, this guidance refers to previously approved FDA
collections of information. These collections of information are
subject to review by OMB under the PRA. The collections of information
in 21 CFR part 58 have been approved under OMB control number 0910-
0119; the collections of information in 21 CFR part 314 have been
approved under OMB control number 0910-0001; the collections of
information in 21 CFR part 312 have been approved under OMB control
number 0910-0014; and the content and format requirements for pregnancy
and lactation labeling of human prescription drug and biological
products have been approved under OMB control number 0910-0624.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at
https://www.regulations.gov, https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, or https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances.

    Dated: May 6, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-10017 Filed 5-11-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: December 3, 2009 (Volume 74, Number 231)]
[Rules and Regulations]
[Page 63309-63310]
[DOCID:fr03de09-6]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2009-0188; FRL-9086-7]

Approval and Promulgation of Air Quality Implementation Plans;
California; Determination of Attainment of the 1997 8-Hour Ozone
Standard

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The EPA is determining that the Imperial County, California
moderate 8-hour ozone nonattainment area has attained the 1997 8-hour
National Ambient Air Quality Standard (NAAQS) for ozone. This
determination is based upon certified ambient air monitoring data that
show the area has monitored attainment of the 8-hour ozone NAAQS since
the 2006-2008 monitoring period. In addition, quality controlled and
quality assured ozone data for 2008 that are available in the EPA Air
Quality System database, but not yet certified, show that this area
continues to attain the 1997 8-hour ozone NAAQS. This determination
suspends the requirements for California to submit an attainment
demonstration, a reasonable further progress plan, contingency
measures, and other planning State Implementation Plans for this area
related to attainment of the 8-hour ozone NAAQS. These requirements
shall remain suspended for so long as the area continues to attain the
ozone NAAQS.

DATES: Effective Date: This rule is effective on January 4, 2010.

ADDRESSES: EPA has established a docket for this action under Docket
Identification No. EPA-R09-OAR-2009-0188. All documents in the docket
are listed on the http://www.regulations.gov Web site. 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
through http://www.regulations.gov or in hard copy at the Air Planning
Office, U.S. Environmental Protection Agency, 75 Hawthorne Street, San
Francisco, CA 94105-3901. EPA requests that if at all possible, you
contact the contact listed in the FOR FURTHER INFORMATION CONTACT
section to schedule your inspection. The Regional Office's official
hours of business are Monday through Friday, 8 to 4:55, excluding
Federal holidays.

FOR FURTHER INFORMATION CONTACT: Wienke Tax, Air Planning Office, U.S.
Environmental Protection Agency Region 9, 75 Hawthorne Street, San
Francisco, CA 94105-3901, telephone number<PHONE_NUMBER>, fax number
(415) 947-3579, electronic mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we,''
``us,'' or ``our'' is used, we mean EPA.

Table of Contents

I. What Action Is EPA Taking?
II. What Is the Effect of This Action?
III. Final Action
IV. Statutory and Executive Order Reviews

I. What Action Is EPA Taking?

    EPA is determining that the Imperial County, California moderate 8-
hour ozone nonattainment area has attained the 1997 8-hour National
Ambient Air Quality Standard (NAAQS) for ozone. This determination is
based upon certified ambient air monitoring data that show the area has
monitored attainment of the 1997 ozone NAAQS since the 2006-2008
monitoring period. In addition, quality controlled and quality assured
ozone data for 2009 that are available in the EPA Air Quality System
(AQS) database, but not yet certified, show that this area continues to
attain the ozone NAAQS.
    Other specific requirements of the determination and the rationale
for EPA's proposed action are explained in the Notice of Proposed
Rulemaking (NPR) published on September 23, 2009 (74 FR 48495) and will
not be restated here. EPA received no public comments on the NPR.

II. What Is the Effect of This Action?

    Under the provisions of EPA's ozone implementation rule (see 40 CFR
51.918), this determination suspends the requirements for the Imperial
County, California moderate ozone nonattainment area to submit an
attainment demonstration, a reasonable further progress plan, section
172(c)(9) contingency measures, and any other planning State
Implementation Plans (SIPs) related to attainment of the 1997 8-hour
ozone NAAQS for so long as the area continues to attain the 1997 ozone
NAAQS.
    This action does not constitute a redesignation to attainment under
CAA section 107(d)(3), because the area does not have an approved
maintenance plan as required under section 175A of the CAA, nor a
determination that the area has met the other requirements for
redesignation. The classification and designation status of the area
remains moderate nonattainment for the 1997 8-hour ozone NAAQS until
such time as EPA determines that it meets the CAA requirements for
redesignation to attainment.
    If EPA subsequently determines, after notice-and-comment rulemaking
in the Federal Register, that the area has violated the 1997 8-hour
ozone standard, the basis for the suspension of these requirements
would no longer exist, and the area would thereafter have to address
the pertinent requirements.

III. Final Action

    EPA is determining that the Imperial County, California 8-hour
ozone nonattainment area has attained the 1997 8-hour ozone standard
and continues to attain the standard based on data through the 2009
ozone season. As provided in 40 CFR 51.918, this determination suspends
the requirements for California to submit an attainment demonstration,
a reasonable further progress plan, and contingency measures under
section 172(c)(9), and any other planning SIP related to attainment of
the 1997 8-hour ozone NAAQS for this area, for so long as the area
continues to attain the standard.

V. Statutory and Executive Order Reviews

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), this
action is not a ``significant regulatory action'' and therefore is not
subject to review by the Office of Management and Budget. For this
reason, this action is also not subject to Executive Order 13211,
``Actions Concerning Regulations That Significantly Affect Energy
Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001). This action
makes a determination based on air quality data, and results in the
suspension of certain Federal requirements. Accordingly, the
Administrator certifies that this rule will not have a significant
economic impact on a substantial number of small entities under the
Regulatory Flexibility Act (5 U.S.C. 601 et seq.). Because this rule
makes a determination based on air quality data, and results in the
suspension of certain Federal requirements, it 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).
    This rule also does not have tribal implications because it will
not have a substantial direct effect on one or more

Indian tribes, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes, as specified by
Executive Order 13175 (59 FR 22951, November 9, 2000). This action also
does not have Federalism implications because it does not 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, as
specified in Executive Order 13132 (64 FR 43255, August 10, 1999),
because it merely makes a determination based on air quality data and
results in the suspension of certain Federal requirements, and does not
alter the relationship or the distribution of power and
responsibilities established in the Clean Air Act. This rule also is
not subject to Executive Order 13045 ``Protection of Children from
Environmental Health Risks and Safety Risks'' (62 FR 19885, April 23,
1997), because it determines that air quality in the affected area is
meeting Federal standards.
    The requirements of section 12(d) of the National Technology
Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply
because it would be inconsistent with applicable law for EPA, when
determining the attainment status of an area, to use voluntary
consensus standards in place of promulgated air quality standards and
monitoring procedures that otherwise satisfy the provisions of the
Clean Air Act.
    This rule does not impose an information collection burden under
the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
et seq.)
    Under Executive Order 12898, EPA finds that this rule involves a
determination of attainment based on air quality data and will not have
disproportionately high and adverse human health or environmental
effects on any communities in the area, including minority and low-
income communities.
    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 rule 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).
    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by May 19, 2008. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this rule 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. This action 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, Intergovernmental relations, Nitrogen dioxide, Ozone,
Reporting and recordkeeping requirements, Volatile organic compounds.

    Dated: November 13, 2009.
Laura Yoshii,
Acting Regional Administrator,
    Region IX.

0
Part 52 of chapter I, title 40 of the Code of Federal Regulations is
amended as follows:

PART 52--[AMENDED]

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

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

Subpart F--California

0
2. Section 52.282 is amended by adding paragraph (c) to read as
follows:

Sec.  52.282  Control strategy and regulations: Ozone.

* * * * *
    (c) Determination of attainment. Effective January 4, 2010, EPA is
determining that the Imperial County, California 8-hour ozone
nonattainment area has attained the 1997 8-hour ozone standard. Under
the provisions of EPA's ozone implementation rule (see 40 CFR 51.918),
this determination suspends the reasonable further progress and
attainment demonstration requirements of section 182(b)(1) and related
requirements of section 172(c)(9) of the Clean Air Act for as long as
the area does not monitor any violations of the 8-hour ozone standard.
If a violation of the 1997 ozone NAAQS is monitored in the Imperial
County, California 8-hour ozone nonattainment area, this determination
shall no longer apply.

[FR Doc. E9-28536 Filed 12-2-09; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 86, Number 70 (Wednesday, April 14, 2021)]
[Notices]
[Pages 19689-19690]
[FR Doc No: 2021-07653]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket Number FRA-2021-0030]

Petition for Waiver of Compliance

    Under part 211 of title 49 Code of Federal Regulations (CFR), this
document provides the public notice that on February 25, 2021, Iowa
Interstate Railroad (IAIS) 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
230, Steam Locomotive Inspection and Maintenance Standards. FRA
assigned the petition Docket Number FRA-2021-0030.
    Specifically, IAIS requests relief for its steam locomotive IAIS
6988, from 49 CFR 230.17(a), One thousand four hundred seventy-two
(1472) service day inspection, to extend the 1472 service day
inspection (SDI) 106 calendar days from September 5, 2021, to December
20, 2021, if coronavirus disease 2019 (COVID-19) restrictions are
reduced to permit servicing and operation. If COVID-19 restrictions are
not lifted, and operation is limited or not permitted in 2021, IAIS
requests an extension of the 1472 SDI until December 20, 2022, a total
of 471 calendar days.
    IAIS states that the COVID-19 public health emergency has caused
IAIS to halt excursion service, which resulted in IAIS 6988 only
accumulating one service day since its 2020 annual inspection. IAIS
anticipates operating IAIS 6988 for about 40 service days in 2021.
Further, IAIS states that during the extension period, all regularly
scheduled maintenance and inspections required will be performed, and
the IAIS 6988 will be stored indoors, serviceable, and drained.
    A copy of the petition, as well as any written communications
concerning the petition, is available for review online at
www.regulations.gov.
    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 parties desire an opportunity for
oral comment and a public hearing, 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:
     Website: http://www.regulations.gov. Follow the online
instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: Docket Operations Facility, U.S. Department of
Transportation (DOT), 1200 New Jersey Ave. SE, W12-140, Washington, DC
20590.
     Hand Delivery: 1200 New Jersey Ave. SE, Room W12-140,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal Holidays.
    Communications received by June 1, 2021 will be considered by FRA
before final action is taken. Comments received after that date will be
considered if practicable.
    Anyone can 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.).
Under 5 U.S.C. 553(c), DOT solicits comments from the public to better
inform its processes. DOT posts these comments, without edit, including
any personal information the commenter provides, to
www.regulations.gov, as described in the system of records notice (DOT/
ALL-14 FDMS), which can be reviewed at https://www.transportation.gov/privacy. See also https://www.regulations.gov/privacy-notice for the
privacy notice of regulations.gov.

    Issued in Washington, DC.
John Karl Alexy,
Associate Administrator for Railroad Safety Chief Safety Officer.
[FR Doc. 2021-07653 Filed 4-13-21; 8:45 am]
BILLING CODE 4910-06-P


CLEAN AIR INTERSTATE RULE DOCKETING FORM NAME OF GROUP: STAPPA/ ALAPCO Emissions and Modeling Committee MEETING_____ SPEECH_____ PHONE CALL_ X__

DATE: July 6, 2004 LOCATION OF MEETING/ SPEECH/ PHONE CALL:

Teleconference from offices in Research Triangle Park, NC to various state and local air agencies.

PURPOSE OF MEETING/ SPEECH/ PHONE CALL:

The purpose of the teleconference was to summarize the emission reporting requirements of CAIR and to answer questions.

ATTENDEES:

EPA/ OAQPS: Phil Lorang, Ron Ryan and Bill Kuykendal STAPPA/ ALAPCO: Mary Stewart Douglass and Roger Westman chaired the call.

COMMENTS:

Topics reviewed and discussed were: ° Addition of 5 states ( AR, IO, LA, MS, WI) to the NO X SIP Call reporting requirements for the 5 month ozone season ° Revision of the definition of " point source" to that of Title V of the CAAA ° Harmonize reporting dates for the NO X SIP Call and CERR to 17 months after the end of the year  comments taken on changing the requirement to 12 months ° Elemination of the NO X SIP Call special 2007 emission inventory ° Elemination of the CERR requirement for reporting biogenic emissions ° Allowing optional reporting of emission model inputs in lieu of emissions calculated by thes models ATTACHMENTS ( HANDOUTS): None


[Federal Register: February 25, 2010 (Volume 75, Number 37)]
[Notices]
[Page 8770-8771]
[DOCID:fr25fe10-141]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-61543; File No. SR-FINRA-2010-005]

Self-Regulatory Organizations; Financial Industry Regulatory
Authority, Inc.; Notice of Filing of Proposed Rule Change To Repeal
Incorporated NYSE Rule 405(4) (Common Sales Accounts)

February 18, 2010.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'')\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on January 21, 2010, Financial Industry Regulatory Authority, Inc.
(``FINRA'') filed with the Securities and Exchange Commission (``SEC''
or ``Commission'') the proposed rule change as described in Items I,
II, and III below, which Items have been prepared by FINRA. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    FINRA is proposing to repeal Incorporated NYSE Rule 405(4) (Common
Sales Accounts) as part of the process to develop the consolidated
FINRA rulebook.
    The text of the proposed rule change is available on FINRA's Web
site at http://www.finra.org, at the principal office of FINRA and at
the Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, FINRA included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. FINRA has prepared summaries, set forth in sections A,
B, and C below, of the most significant aspects of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    As part of the process of developing a new consolidated rulebook
(``Consolidated FINRA Rulebook''),\3\ FINRA is proposing to repeal NYSE
Rule 405(4) (Common Sales Accounts).\4\
---------------------------------------------------------------------------

    \3\ The current FINRA rulebook consists of (1) FINRA Rules; (2)
NASD Rules; and (3) rules incorporated from the New York Stock
Exchange (``Incorporated NYSE Rules'') (together, the NASD Rules and
Incorporated NYSE Rules are referred to as the ``Transitional
Rulebook''). While the NASD Rules generally apply to all FINRA
members, the Incorporated NYSE Rules apply only to those members of
FINRA that are also members of the NYSE (``Dual Members''). The
FINRA Rules apply to all FINRA members, unless such rules have a
more limited application by their terms. For more information about
the rulebook consolidation process, see Information Notice, March
12, 2008 (Rulebook Consolidation Process).
    \4\ For convenience, the Incorporated NYSE Rules are referred to
as the ``NYSE Rules.''
---------------------------------------------------------------------------

    NYSE Rule 405(4) (Common Sales Accounts) requires proper
supervision of registered representatives handling common sales
accounts. The rule provides that a member may facilitate the isolated
liquidation of securities valued at $1,000 or less registered in the
name of an individual who does not have an account, and which are not
part of any distribution, through a common sales account set up for the
specific purpose of handling such sales. The rule further provides that
such sales may be effected on behalf of the customer without requiring
the member to send a periodic customer account statement to the
individual as otherwise generally required, provided the following
conditions are satisfied: (1) The customer is identified as the
individual in whose name the securities are registered; (2) the
securities are received by the member, at or prior to the time of the
entry of the order, in the exact amount to be sold in good delivery
form; (3) a confirmation is sent to the customer; (4) all proceeds of
such sales are paid out on or immediately following settlement date;
and (5) a record is made in the common sales account that includes
certain customer-specific information.
    FINRA believes that the rule as written may raise potential
investor protection concerns. The term ``isolated'' is not defined.\5\
Further, NYSE Rule 405(4) permits a member to effect sales of
securities for customers without expressly requiring prior customer
consent and without the need to send periodic account statements to the
customer. For these reasons, FINRA proposes to eliminate NYSE Rule
405(4) and not adopt its content into the Consolidated FINRA
Rulebook.\6\
---------------------------------------------------------------------------

    \5\ NYSE Rule 405(4) was adopted by the NYSE in the late 1960's.
In 1977, the NYSE proposed amendments to Rule 405(4) to define the
term ``isolated'' to mean ``not exceeding five $2,000 transactions
during any twelve-month period unless otherwise approved by the
NYSE,'' and to allow unsolicited purchases as well as sales of
securities. In late 1977, the SEC instituted proceedings to
determine whether to disapprove the proposed rule change and
identified the potential grounds for disapproval. See Securities
Exchange Act Release No. 14143 (November 7, 1977) (Order Instituting
Proceedings to Determine Whether Proposed Changes to Rule 405 Should
be Disapproved; File No. SR-NYSE-76-34). The SEC expressed concern
that ``execution of such transactions, and in particular of
purchases [as proposed], in the common purchase and sale account may
permit opportunities for fraudulent and manipulative acts or
practices[.]'' In February 1978, the NYSE withdrew the filing. See
Securities Exchange Act Release No. 14630 (April 3, 1978) (Order
Approving Withdrawal of NYSE's Proposed Changes to Rule 405; File
No. SR-NYSE-76-34).
    \6\ FINRA notes that in the event a member may seek permission
not to send customer account statements under certain limited
circumstances, proposed FINRA Rule 2231 which relates to customer
account statements, would authorize FINRA to exempt members from the
provisions of such rule, including the requirement to deliver
periodic account statements, pursuant to the Rule 9600 Series. See
Securities Exchange Act Release No. 59921 (May 14, 2009), 74 FR
23912 (May 21, 2009) (Notice of Filing; File No. SR-FINRA-2009-028).
---------------------------------------------------------------------------

    FINRA will announce the implementation date of the proposed rule
change in a Regulatory Notice to be published no later than 90 days
following Commission approval. The implementation date will be no later
than 180 days following Commission approval.
2. Statutory Basis
    FINRA believes that the proposed rule change is consistent with the
provisions

of Section 15A(b)(6) of the Act,\7\ which requires, among other things,
that FINRA rules must be designed to prevent fraudulent and
manipulative acts and practices, to promote just and equitable
principles of trade, and, in general, to protect investors and the
public interest. FINRA believes that the proposed rule change will
streamline and improve FINRA's rulebook by eliminating a rule that
contains terms that are not clearly defined and may raise potential
investor protection concerns.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78o-3(b)(6).
---------------------------------------------------------------------------

B. Self-Regulatory Organization's Statement on Burden on Competition

    FINRA does not believe that the proposed rule change will result in
any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    Written comments were neither solicited nor received.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Within 35 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:
    (A) By order approve such proposed rule change, or
    (B) Institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-FINRA-2010-005 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-FINRA-2010-005. This
file number should be included on the subject line if e-mail is used.
To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/
rules/sro.shtml). Copies of the submission, all subsequent amendments,
all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for Web site
viewing and printing in the Commission's Public Reference Room, 100 F
Street, NE., Washington, DC 20549, on official business days between
the hours of 10 a.m. and 3 p.m. Copies of such filing also will be
available for inspection and copying at the principal office of FINRA.
All comments received will be posted without change; the Commission
does not edit personal identifying information from submissions. You
should submit only information that you wish to make available
publicly. All submissions should refer to File Number SR-FINRA-2010-005
and should be submitted on or before March 18, 2010.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\8\
---------------------------------------------------------------------------

    \8\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-3780 Filed 2-24-10; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 87, Number 187 (Wednesday, September 28, 2022)]
[Notices]
[Pages 58788-58789]
[FR Doc No: 2022-21006]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER22-2898-000]

Huck Finn Solar, LLC; Supplemental Notice That Initial Market-
Based Rate Filing Includes Request for Blanket Section 204
Authorization

    This is a supplemental notice in the above-referenced proceeding of
Huck Finn Solar, LLC's application for market-based rate authority,
with an accompanying rate tariff, noting that

such application includes a request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE, Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is October 12, 2022.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically may mail similar pleadings to
the Federal Energy Regulatory Commission, 888 First Street NE,
Washington, DC 20426. Hand delivered submissions in docketed
proceedings should be delivered to Health and Human Services, 12225
Wilkins Avenue, Rockville, Maryland 20852.
    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 the Federal Energy
Regulatory Commission at [email protected] or call toll-free,
(886) 208-3676 or TYY,<PHONE_NUMBER>.

    Dated: September 22, 2022.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2022-21006 Filed 9-27-22; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 78, Number 87 (Monday, May 6, 2013)]
[Rules and Regulations]
[Pages 26255-26258]
[FR Doc No: 2013-10546]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R06-OAR-2012-0766; FRL-9808-4]

Approval and Promulgation of Air Quality Implementation Plans;
Texas; Approval of Texas Low Emission Diesel Fuel Rule Revisions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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

SUMMARY: EPA is granting direct final approval of a revision to the
Texas State Implementation Plan (SIP) concerning the Texas Low Emission
Diesel fuel rules. The revisions clarify existing definitions and
provisions, revise the approval procedures for alternative diesel fuel
formulations, add new registration requirements, and update the rule to
reflect the current program status because the rule is now fully
implemented. This SIP revision meets statutory requirements.

DATES: This rule is effective on July 5, 2013 without further notice,
unless EPA receives relevant adverse comment by June 5, 2013. If EPA
receives such comment, EPA will publish a timely withdrawal in the
Federal Register informing the public that this rule will not take
effect.

ADDRESSES: Submit your comments, identified by Docket No. EPA-R06-OAR-
2012-0766, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     EPA Region 6 ``Contact Us'' Web site: http://epa.gov/region6/r6coment.htm. Please click on ``6PD'' (Multimedia) and select
``Air'' before submitting comments.
     Email: Mr. Guy Donaldson at<EMAIL_ADDRESS>Please
also send a copy by email to the person listed in the FOR FURTHER
INFORMATION CONTACT section below.
     Fax: Mr. Guy Donaldson, Chief, Air Planning Section (6PD-
L), at fax number<PHONE_NUMBER>.
     Mail: Mr. Guy Donaldson, Chief, Air Planning Section (6PD-
L), Environmental Protection Agency, 1445 Ross Avenue, Suite 1200,
Dallas, Texas 75202-2733.
     Hand or Courier Delivery: Mr. Guy Donaldson, Chief, Air
Planning Section (6PD-L), Environmental Protection Agency, 1445 Ross
Avenue, Suite 1200, Dallas, Texas 75202-2733. Such deliveries are
accepted only between the hours of 8:00 a.m. and 4:00 p.m. weekdays
except for legal holidays. Special arrangements should be made for
deliveries of boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-R06-OAR-
2012-0766. 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 email. 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 docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in www.regulations.gov or in hard copy at the Air Planning Section
(6PD-L), Environmental Protection Agency, 1445 Ross Avenue, Suite 700,
Dallas, Texas 75202-2733. The file will be made available by
appointment for public inspection in the Region 6 FOIA Review Room
between the hours of 8:30 a.m.

and 4:30 p.m. weekdays except for legal holidays. Contact the person
listed in the FOR FURTHER INFORMATION CONTACT paragraph below or Mr.
Bill Deese at<PHONE_NUMBER> to make an appointment. If possible, please
make the appointment at least two working days in advance of your
visit. There will be a 15 cent per page fee for making photocopies of
documents. On the day of the visit, please check in at the EPA Region 6
reception area at 1445 Ross Avenue, Suite 700, Dallas, Texas.
    The State submittal is also available for public inspection at the
State Air Agency listed below during official business hours by
appointment:
    Texas Commission on Environmental Quality, 12100 Park 35 Circle,
Building E, Austin, Texas 78753, and at the commission's Web site at
http://www/tceq.texas.gov/nav/rules/propose_adopt.html.

FOR FURTHER INFORMATION CONTACT: Ms. Sandra Rennie, Air Planning
Section (6PD-L), Environmental Protection Agency, Region 6, 1445 Ross
Avenue, Suite 700, Dallas, Texas 75202-2733, telephone<PHONE_NUMBER>;
fax number<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, whenever ``we''
``us'' or ``our'' is used, we mean the EPA.

Outline

I. Background
II. Analysis of the State's Submittal
III. Final Action
IV. Statutory and Executive Order Reviews

I. Background

    The Texas Low Emission Diesel (TxLED) fuel program was initially
approved by EPA on November 14, 2001 (66 FR 57196). It was revised on
April 6, 2005 (70 FR 17321), October 6, 2005 (70 FR 58325), and October
24, 2008 (73 FR 63378). The TxLED fuel is similar to CARB (California
Air Resources Board) diesel and is required for use by on-highway
vehicles and non-road equipment (including marine vessels) in 110
counties in eastern and central Texas. Use of this boutique diesel fuel
reduces NOX emissions.
    Texas submitted a revision to the TxLED rules on September 19,
2012. The rulemaking revises definitions; establishes new designated
alternative limits for TxLED fuel properties; removes expired
registration requirements and establishes new registration requirements
for identifying production and import facilities; revises approval
procedures for alternative diesel fuel formulations; specifies that the
approvals of all additive-based alternative diesel fuel formulations
will be subject to revocation if the composition of the additive is
found to be altered; allows all alternative diesel formulations
approved by the TCEQ prior to April 1, 2012, to remain in effect;
revises reporting requirements to include production and import
facility data; requires alternative emission reduction plans using the
Unified Model to determine compliance each calendar quarter; removes
expired early gasoline sulfur reduction credits provisions; and makes
other clarifying changes as needed for accuracy and consistency.

II. Analysis of the State's Submittal

    We compared the rule revisions for stringency against the rule
language in the approved SIP. Revisions are made to the following
sections: Sec.  114.6, Definitions; Sec.  114.312, Low Emission Diesel
Standards; Sec.  114.313, Designated Alternative Limits; Sec.  114.314,
Registration of Diesel Producers and Importers; Sec.  114.315, Approved
Test Methods; Sec.  114.316, Monitoring, Recordkeeping, and Reporting
Requirements; Sec.  114.317 Exemptions to Low Emission Diesel
Requirements; Sec.  114.318, Alternative Emission Reduction Plan; Sec.
114.319, Affected Counties and Compliance Dates.
    We found that the revisions to the rule did not compromise the
integrity of the approved SIP. In some cases, the revisions made the
rule more stringent than the approved SIP. See the Technical Support
Document that accompanies this action for a detailed analysis of the
revisions.

III. Final Action

    Pursuant to section 110 of the Act, EPA is approving revisions to
the TxLED rule that were submitted on September 19, 2012. We evaluated
the State's submittal and determined that it meets the applicable
requirements of the Clean Air Act (CAA) section 110. Approval of this
submittal will not result in any increase in ozone concentration
levels. In accordance with CAA section 110(l), these revisions will not
interfere with attainment of the National Ambient Air Quality Standards
(NAAQS), Rate of Progress, reasonable further progress, or any other
applicable requirement of the CAA.
    EPA is publishing this rule without prior proposal because we view
this as a non-controversial amendment and anticipate no adverse
comments. However, in the proposed rules section of this Federal
Register publication, we are publishing a separate document that will
serve as the proposal to approve the SIP revision if relevant adverse
comments are received. This rule will be effective on July 5, 2013
without further notice unless we receive adverse comment by June 5,
2013. If we receive adverse comments, we will publish a timely
withdrawal in the Federal Register informing the public that the rule
will not take effect. We will address all public comments in a
subsequent final rule based on the proposed rule. We will not institute
a second comment period on this action. Any parties interested in
commenting must do so now. Please note that if we receive adverse
comment on an amendment, paragraph, or section of this rule and if that
provision may be severed from the remainder of the rule, we may adopt
as final those provisions of the rule that are not the subject of an
adverse comment.

IV. 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 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 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 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.
    The Congressional Review Act, 5 U.S.C. section 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).
    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by July 5, 2013. 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. This action 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, Carbon monoxide,
Incorporation by reference, Intergovernmental relations, Lead, Nitrogen
dioxide, Ozone, Particulate matter, Reporting and recordkeeping
requirements, Sulfur oxides, Volatile organic compounds.

    Dated: April 5, 2013.
Ron Curry,
Regional Administrator, Region 6.

    40 CFR part 52 is amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

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

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

Subpart SS--Texas

0
2. The table in Sec.  52.2270(c) entitled ``EPA Approved Regulations in
the Texas SIP'' is amended under ``Chapter 114 (Reg 4)--Control of Air
Pollution from Motor Vehicles'' by revising the entries for Section
114.6 and for Sections 114.312 through 114.319 to read as follows:

Sec.  52.2270  Identification of plan.

* * * * *
    (c) * * *

                                    EPA-Approved Regulations in the Texas SIP
----------------------------------------------------------------------------------------------------------------
                                                        State approval/
          State citation              Title/subject        submittal     EPA approval date       Explanation
                                                             date
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                        Chapter 114 (Reg 4)--Control of Air Pollution from Motor Vehicles
                                            Subchapter A--Definitions
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
Section 114.6....................  Low Emission Fuel           8/22/12  5/6/13,
                                    Definitions.                        [Insert FR page
                                                                         number where
                                                                         document begins].

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                                        Subchapter H--Low Emission Fuels
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                                         Division 2: Low Emission Diesel
----------------------------------------------------------------------------------------------------------------
Section 114.312..................  Low Emission Diesel         8/22/12  5/6/13 [Insert FR
                                    Standards.                           page number where
                                                                         document begins].
Section 114.313..................  Designated                  8/22/12  5/6/13 [Insert FR
                                    Alternative Limits.                  page number where
                                                                         document begins].
Section 114.314..................  Registration of             8/22/12  5/6/13 [Insert FR
                                    Diesel Producers                     page number where
                                    and Importers.                       document begins].

Section 114.315..................  Approved Test               8/22/12  5/6/13 [Insert FR
                                    Methods.                             page number where
                                                                         document begins].
Section 114.316..................  Monitoring,                 8/22/12  5/6/13 [Insert FR
                                    Recordkeeping, and                   page number where
                                    Reporting                            document begins].
                                    Requirements.
Section 114.317..................  Exemptions to Low           8/22/12  5/6/13 [Insert FR
                                    Emission Diesel                      page number where
                                    Requirements.                        document begins].
Section 114.318..................  Alternative                 8/22/12  5/6/13 [Insert FR
                                    Emission Reduction                   page number where
                                    Plan.                                document begins].
Section 114.319..................  Affected Counties           8/22/12  5/6/13 [Insert FR
                                    and Compliance                       page number where
                                    Dates.                               document begins].

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

* * * * *
[FR Doc. 2013-10546 Filed 5-3-13; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 82, Number 187 (Thursday, September 28, 2017)]
[Rules and Regulations]
[Pages 45175-45177]
[FR Doc No: 2017-20702]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2017-0753; Product Identifier 2017-NE-25-AD; Amendment
39-19046; AD 2017-2017-19-16]
RIN 2120-AA64

Airworthiness Directives; Rolls-Royce plc Turbofan Engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; request for comments.

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SUMMARY: We are adopting a new airworthiness directive (AD) for certain
Rolls-Royce plc (RR) RB211 Trent 553-61, Trent 553A2-61, Trent 556-61,
Trent 556A2-61, Trent 556B-61, Trent 556B2-61, Trent 560-61, and Trent
560A2-61 turbofan engines. This AD requires replacement of the low-
pressure compressor (LPC) case A-frame hollow locating pins. This AD
was prompted by LPC case A-frame hollow locating pins that may have
reduced integrity due to incorrect heat treatment. We are issuing this
AD to correct the unsafe condition on these products.

DATES: This AD becomes effective October 13, 2017.
    The Director of the Federal Register approved the incorporation by
reference of a certain publications listed in this AD as of October 13,
2017.
    We must receive comments on this AD by November 13, 2017.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Mail: U.S. Department of Transportation, 1200 New Jersey
Avenue SE., West Building Ground Floor, Room W12-140, Washington, DC
20590-0001.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
     Fax:<PHONE_NUMBER>.
    For service information identified in this AD, contact Rolls-Royce
plc, Corporate Communications, P.O. Box 31, Derby, England, DE24 8BJ;
phone: 011-44-1332-242424; fax: 011-44-1332-249936; email: http://www.rolls-royce.com/contact/civil_team.jsp; Internet: https://customers.rolls-royce.com/public/rollsroycecare. You may view this
service information at the FAA, Engine and Propeller Standards Branch,
Policy and Innovation Division,

1200 District Avenue, Burlington, MA 01803. For information on the
availability of this material at the FAA, call<PHONE_NUMBER>. It is also
available on the Internet at http://www.regulations.gov by searching
for and locating Docket No. FAA-2017-0753.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-
0753; or in person at the Docket Operations office between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. The AD docket
contains this AD, the mandatory continuing airworthiness information
(MCAI), regulatory evaluation, any comments received, and other
information. The address for the Docket Office (phone:<PHONE_NUMBER>) is
in the ADDRESSES section. Comments will be available in the AD docket
shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Robert Green, Aerospace Engineer, FAA,
ECO Branch, Compliance and Airworthiness Division, 1200 District
Avenue, Burlington, MA 01803; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>;
email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    This AD is a final rule that involves requirements affecting flight
safety, and we did not precede it by notice and opportunity for public
comment. We invite you to send any written relevant data, views, or
arguments about this AD. Send your comments to an address listed under
the ADDRESSES section. Include ``Docket No. FAA-2017-0753; Product
Identifier 2017-NE-25-AD'' at the beginning of your comments. We
specifically invite comments on the overall regulatory, economic,
environmental, and energy aspects of this AD. We will consider all
comments received by the closing date and may amend this AD because of
those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact
with FAA personnel concerning this AD.

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Community, has issued EASA
AD 2017-0012, dated January 25, 2017 (referred to hereinafter as ``the
MCAI''), to correct an unsafe condition for the specified products. The
MCAI states:

    All low pressure compressor (LPC) case A-frame hollow locating
pins, Part Number (P/N) FK32009, manufactured since 2012 have
potentially been subjected to incorrect heat treatment. This may
have reduced the integrity of the pin such that in a Fan Blade Off
(FBO) event it is unable to withstand the applied loads. This
condition, if not corrected, could lead to loss of location of the
A-frame following an FBO event, possibly resulting in engine
separation, loss of thrust reverser unit, release of high-energy
debris, or an uncontrolled fire. To address this potential unsafe
condition, RR identified the affected engines that have these A-
frame hollow locating pins installed and published Alert NMSB
RB.211-72-AJ451, providing instructions for replacement of these
pins. For the reason described above, this AD requires a one-time
replacement of the A-frame hollow locating pins P/N FK32009 on the
affected engines.

    You may obtain further information by examining the MCAI in the AD
docket on the Internet at http://www.regulations.gov by searching for
and locating Docket No. FAA-2017-0753.

Related Service Information Under 1 CFR Part 51

    RR has issued Alert Non Modification Service Bulletin (NMSB) No.
RB.211-72-AJ451, Revision 1, dated March 10, 2017. The SB describes
procedures for replacement of all non-conforming A-frame locating pins.
This service information 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.

FAA's Determination and Requirements of This AD

    This product has been approved by the aviation authority of the
United Kingdom, and is approved for operation in the United States.
Pursuant to our bilateral agreement with the European Community, EASA
has notified us of the unsafe condition described in the MCAI and
service information referenced above. We are issuing this AD because we
evaluated all information provided by EASA and determined the unsafe
condition exists and is likely to exist or develop on other products of
the same type design. This AD requires replacement of all non-
conforming A-frame locating pins.

FAA's Determination of the Effective Date

    No domestic operators use this product. Therefore, we find that
notice and opportunity for prior public comment are unnecessary and
that good cause exists for making this amendment effective in less than
30 days.

Costs of Compliance

    We estimate that this AD affects no engines installed on airplanes
of U.S. registry.
    We estimate the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
               Action                         Labor cost            Parts cost        product        operators
----------------------------------------------------------------------------------------------------------------
A-frame pin replacement............  4 work-hours x $85 per hour         $450.00         $790.00              $0
                                      = $340.00.
----------------------------------------------------------------------------------------------------------------

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.
    We are 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.
    This AD is issued in accordance with authority delegated by the
Executive Director, Aircraft Certification Service, as authorized by
FAA Order 8000.51C. In accordance with that order, issuance

of ADs is normally a function of the Compliance and Airworthiness
Division, but during this transition period, the Executive Director has
delegated the authority to issue ADs applicable to engines, propellers,
and associated appliances to the Manager, Engine and Propeller
Standards Branch, Policy and Innovation Division.

Regulatory Findings

    We determined that 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 this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska to the extent
that it justifies making a regulatory distinction, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

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

2017-19-16 Rolls-Royce plc: Amendment 39-19046; Docket No. FAA-2017-
0753; Product Identifier 2017-NE-25-AD.

(a) Effective Date

    This AD is effective October 13, 2017.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Rolls-Royce plc (RR) RB211 Trent 553-61,
Trent 553A2-61, Trent 556-61, Trent 556A2-61, Trent 556B-61, Trent
556B2-61, Trent 560-61, and Trent 560A2-61 turbofan engines with an
engine serial number (ESN) listed in Section 1.A., Effectivity, of
RR Alert Non Modification Service Bulletin (NMSB) RB.211-72-AJ451,
Revision 1, dated March 10, 2017.

(d) Subject

    Joint Aircraft System Component (JASC) Code 7230, Turbine Engine
Compressor Section.

(e) Reason

    This AD was prompted by low-pressure compressor (LPC) case A-
frame hollow locating pins that may have reduced integrity due to
incorrect heat treatment. We are issuing this AD to prevent failure
of the locating pins, engine separation, and loss of the airplane.

(f) Compliance

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

(g) Required Actions

    At the next scheduled maintenance inspection after the effective
date of this AD, but no later than January 1, 2018, replace each
affected LPC case A-frame hollow locating pin with a part eligible
for installation using Section 3, Accomplishment Instructions, of RR
Alert NMSB RB.211-72-AJ451, Revision 1, dated March 10, 2017.

(h) Installation Prohibition

    After the effective date of this AD, do not install any engine
with an affected LPC case A-frame hollow locating pin.

(i) Definitions

    For the purposes of this AD:
    (1) An affected LPC case A-frame hollow locating pin is part
number (P/N) FK32009, except those with an original RR authorized
release certificate dated July 5, 2016, or later.
    (2) A part eligible for installation is an LPC case A-frame
hollow locating pin with an original RR authorized release
certificate dated July 5, 2016, or later.

(j) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, FAA, ECO Branch, Compliance and Airworthiness
Division, has the authority to approve AMOCs for this AD, if
requested using the procedures found in 14 CFR 39.19. In accordance
with 14 CFR 39.19, send your request to your principal inspector or
local Flight Standards District Office, as appropriate. If sending
information directly to the manager of the ECO Branch, send it to
the attention of the person identified in paragraph (k)(1) of this
AD. You may email your request to<EMAIL_ADDRESS>    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.

(k) Related Information

    (1) For more information about this AD, contact Robert Green,
Aerospace Engineer, FAA, ECO Branch, Compliance and Airworthiness
Division, 1200 District Avenue, Burlington, MA 01803; phone: 781-
238-7754; fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>    (2) Refer to MCAI European Aviation Safety Agency AD 2017-0012,
dated January 25, 2017, for more information. You may examine the
MCAI in the AD docket on the Internet at http://www.regulations.gov
by searching for and locating it in Docket No. FAA-2017-0753.

(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 the AD specifies otherwise.
    (i) Rolls-Royce plc (RR) Alert Non Modification Service Bulletin
RB.211-72-AJ451, Revision 1, dated March 10, 2017.
    (ii) Reserved.
    (3) For RR service information identified in this AD, contact
Rolls-Royce plc, Corporate Communications, P.O. Box 31, Derby,
England, DE24 8BJ; phone: 011-44-1332-242424; fax: 011-44-1332-
249936; email: http://www.rolls-royce.com/contact/civil_team.jsp;
Internet: https://customers.rolls-royce.com/public/rollsroycecare.
    (4) You may view this service information at FAA, Engine and
Propeller Standards Branch, Policy and Innovation Division, 1200
District Avenue, Burlington, MA 01803. For information on the
availability of this material at the FAA, call<PHONE_NUMBER>.
    (5) You may view this service information at the National
Archives and Records Administration (NARA). For information on the
availability of this material at NARA, call<PHONE_NUMBER>, or go to:
http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Burlington, Massachusetts, on September 13, 2017.
Robert J. Ganley,
Manager, Engine and Propeller Standards Branch, Aircraft Certification
Service.
[FR Doc. 2017-20702 Filed 9-27-17; 8:45 am]
 BILLING CODE 4910-13-P