[Federal Register Volume 86, Number 79 (Tuesday, April 27, 2021)]
[Notices]
[Pages 22213-22214]
[FR Doc No: 2021-08675]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-D-0320]

Nonclinical Testing of Individualized Antisense Oligonucleotide
Drug Products for Severely Debilitating or Life-Threatening Diseases;
Draft Guidance for Sponsor-Investigators; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled
``Nonclinical Testing of Individualized Antisense Oligonucleotide Drug
Products for Severely Debilitating or Life-Threatening Diseases.'' FDA
is publishing this draft guidance to help sponsor-investigators
(hereafter referred to as sponsors) with developing the nonclinical
information that FDA recommends to support an investigational new drug
application (IND) for certain individualized antisense oligonucleotide
(ASO) drug products. ASO drug products that are the focus of this draft
guidance are those being developed to treat rapidly progressing,
severely debilitating or life-threatening (SDLT) disease attributable
to a unique genetic variant or variants that may be amenable to RNA-
directed treatment.

DATES: Submit either electronic or written comments on the draft
guidance by June 28, 2021 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2021-D-0320 for ``Nonclinical Testing of Individualized Antisense
Oligonucleotide Drug Products for Severely Debilitating or Life-
Threatening Diseases.'' 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, 240-
402-7500.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Ronald Wange, Center for Drug
Evaluation and Research (HFD-510), Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 22, Rm. 3342, Silver Spring, MD 20903, 301-
796-1304.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Nonclinical Testing of Individualized Antisense
Oligonucleotide Drug Products for Severely Debilitating or Life-
Threatening Diseases.'' FDA is publishing this draft guidance, that,
when finalized, will help sponsors with developing the nonclinical
information that FDA recommends to support an IND for certain
individualized ASO drug products. ASO drug products that are the focus
of this draft guidance are those being developed to treat a rapidly
progressing, SDLT disease attributable

to a unique genetic variant or variants that may be amenable to RNA-
directed treatment.
    The draft guidance addresses the nonclinical information that FDA
recommends to support an IND for the development of an antisense
oligonucleotide from a well-characterized chemical class, for which
there is substantial nonclinical information and clinical experience
that is publicly available or to which the sponsor has a right of
reference. The draft guidance discusses the importance of sponsors
providing convincing in vitro and/or in vivo proof of concept data as
part of any such IND submission. The draft guidance describes
recommended nonclinical safety studies that should be submitted with
such IND submissions, the duration and timing of general toxicity
studies, first-in-human dose selection, and dose escalation, each
within the context stipulated above. Finally, the draft guidance
describes certain factors, present in the context of an IND for an
individualized investigational antisense oligonucleotide developed to
treat a rapidly progressing SDLT disease, that support differences in
the nonclinical safety package recommended in this context from that
generally recommended for non-SDLT diseases, for modalities other than
antisense oligonucleotides, and for use in larger patient populations.
    The draft guidance is intended to help sponsors of such development
programs, who may be relatively unfamiliar with FDA regulations,
processes, and practices, seek feedback from FDA on their development
programs and make regulatory submissions related to these development
programs. The draft guidance is expected to facilitate the preparation
of adequate pre-IND and IND submissions for review by the Agency that
will enable prompt initiation of the clinical trial.
    This draft guidance represents the second in a series of guidances
FDA intends to publish to advise and help sponsors developing
individualized ASO drug products for individuals who have SDLT diseases
or conditions and no approved products available to them to treat their
disease.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Nonclinical
Testing of Individualized Antisense Oligonucleotide Drug Products for
Severely Debilitating or Life-Threatening Diseases.'' 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

    FDA tentatively concludes that this draft 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 draft guidance refers to previously approved FDA
collections of information. These collections of information are
subject to review by OMB under the PRA.
     The following collections of information in 21 CFR part
312 (IND regulations) have been approved under OMB control number 0910-
0014: (1) Submissions of IND applications, amendments, safety reports,
and investigator brochures and (2) requests for pre-IND meetings.
     The collections of information in 21 CFR parts 50 and 56
for obtaining informed consent for prospective patients have been
approved under OMB control number 0910-0130.
     The collections of information for paper submissions of
Form FDA 3500A (Mandatory Reporting) have been approved under OMB
control number 0910-0291.
     The collections of information in the final guidance
entitled ``Formal Meetings Between the FDA and Sponsors or Applicants''
have been approved under OMB control number 0910-0429.
     The collections of information relating to electronic
submissions of Form FDA 3500 used for voluntary reporting (not mandated
by law or regulation) by healthcare professionals, including safety
reporting submissions relating to bioavailability and bioequivalence
studies under 21 CFR 320.31(d)(3), have been approved under OMB control
number 0910-0645.

III. Electronic Access

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

    Dated: April 20, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-08675 Filed 4-26-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 29 (Friday, February 11, 2022)]
[Notices]
[Pages 8082-8083]
[FR Doc No: 2022-02937]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket No. FRA-2022-0002-N-3]

Proposed Agency Information Collection Activities; Comment
Request

AGENCY: Federal Railroad Administration (FRA), U.S. Department of
Transportation (DOT).

ACTION: Notice of information collection; request for comment.

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SUMMARY: Under the Paperwork Reduction Act of 1995 (PRA) and its
implementing regulations, FRA seeks approval of the Information
Collection Request (ICR) abstracted below. Before submitting this ICR
to the Office of Management and Budget (OMB) for approval, FRA is
soliciting public comment on specific aspects of the activities
identified in the ICR.

DATES: Interested persons are invited to submit comments on or before
April 12, 2022.

ADDRESSES: Written comments and recommendations for the proposed ICR
should be submitted on regulations.gov to the docket, Docket No. FRA-
2022-0002. All comments received will be posted without change to the
docket, including any personal information provided. Please refer to
the assigned OMB control number in any correspondence submitted. FRA
will summarize comments received in response to this notice in a
subsequent notice and include them in its information collection
submission to OMB for approval.

FOR FURTHER INFORMATION CONTACT: Ms. Hodan Wells, Information
Collection Clearance Officer, at email: [email protected] or
telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The PRA, 44 U.S.C. 3501-3520, and its
implementing regulations, 5 CFR part 1320, require Federal agencies to
provide 60-days' notice to the public to allow comment on information
collection activities before seeking OMB approval of the activities.
See 44 U.S.C. 3506, 3507; 5 CFR 1320.8 through 1320.12. Specifically,
FRA invites interested parties to comment on the following ICR
regarding: (1) Whether the information collection activities are
necessary for FRA to properly execute its functions, including whether
the activities will have practical utility; (2) the accuracy of FRA's
estimates of the burden of the information collection activities,
including the validity of the methodology and assumptions used to
determine the estimates; (3) ways for FRA to enhance the quality,
utility, and clarity of the information being collected; and (4) ways
for FRA to minimize the burden of information collection activities on
the public, including the use of automated collection techniques or
other forms of information technology. See 44 U.S.C. 3506(c)(2)(A); 5
CFR 1320.8(d)(1).
    FRA believes that soliciting public comment may reduce the
administrative and paperwork burdens associated with the collection of
information that Federal regulations mandate. In summary, FRA reasons
that comments received will advance three objectives: (1) Reduce
reporting burdens; (2) organize information collection requirements in
a ``user-friendly'' format to improve the use of such information; and
(3) accurately assess the resources

expended to retrieve and produce information requested. See 44 U.S.C.
3501.
    The summary below describes the ICR that FRA will submit for OMB
clearance as the PRA requires:
    Title: State Safety Participation Regulations and Reporting of
Remedial Actions.
    OMB Control Number: 2130-0509.
    Abstract: The collection of information is set forth under 49 CFR
part 212, and requires qualified State inspectors to provide various
reports to FRA for monitoring and enforcement purposes concerning State
investigative, inspection, and surveillance activities regarding
railroad compliance with Federal railroad safety laws and regulations.
Additionally, under 49 CFR part 209, subpart E, railroads are required
to report to FRA actions taken to remedy certain alleged violations of
law.
    Type of Request: Extension without change (with changes in
estimates) of a currently approved collection.
    Affected Public: Businesses.
    Form(s): FRA F 6180.33/61/67/96/96A/109/110/111/112/144.
    Respondent Universe: States and railroads.
    Frequency of Submission: On occasion.
    Reporting Burden:

----------------------------------------------------------------------------------------------------------------
                                                                                Total
                                    Respondent        Total annual    Average time per     annual     Total cost
          Section \1\                universe          responses          response         burden     equivalent
                                                                                hours
                                                   (A)..............  (B).............  (C) = A * B    (D) = C *
                                                                                wage \2\
----------------------------------------------------------------------------------------------------------------
49 U.S.C. 20105--Railroad       32 States........  32 updates.......  1 hour..........           32       $2,615
 Safety State Participation
 Agreement--Annual updates or
 amendments including
 workplans, training plans and
 schedules to existing
 agreements.
    --Inspector travel          32 States........  600 vouchers.....  1.5 hours.......          900       73,539
     planning and
     reimbursement.
                               ---------------------------------------------------------------------------------
212.107--Certification--State   FRA anticipates zero submissions.
 to file annual certification
 in the event that FRA and the
 State agency do not agree on
 terms for the participation
 under Sec.   212.105.
                               ---------------------------------------------------------------------------------
212.109--Joint planning of      The burden associated with this requirement is covered above under 49 U.S.C.
 inspections--Annual work plan   20105.
 for the conduct of
 investigative and
 surveillance activities by
 the State agency.
                               ---------------------------------------------------------------------------------
212.113--Program termination--  FRA anticipates zero submissions.
 30-day notice provided by
 State agency of its intent to
 terminate its participation.
                               ---------------------------------------------------------------------------------
    --Inspection Report (Form   32 States........  19,400 forms.....  15 minutes......        4,850      396,294
     FRA F 6180.96)--All
     disciplines submitted by
     State inspectors.
    --Violation Report--        19 States........  360 reports......  4 hours.........        1,440      117,662
     Motive, Power, and
     Equipment Regulations
     (Form FRA F 6180.109).
    --Violation Report--        19 States........  180 reports......  4 hours.........          720       58,831
     Operating Practices
     Regulations (Form FRA F
     6180.67).
    --Violation Report--        17 States........  420 reports......  4 hours.........        1,680      137,273
     Hazardous Materials
     Regulations (Form FRA F
     6180.110).
    --Violation Report--Hours   19 States........  2 reports........  4 hours.........            8          654
     of Service Law (F
     6180.33).
    --Violation Report--        19 States........  2 reports........  4 hours.........            8          654
     Accident/Incident
     Reporting Rules (Form FRA
     F 6180.61).
    --Violation Report--Track   26 States........  110 reports......  4 hours.........          440       35,952
     Safety Regulations (Form
     FRA F 6180.111).
    --Violation Report--Signal  14 States........  80 reports.......  4 hours.........          320       26,147
     and Train Control
     Regulations (Form FRA F
     6180.112).
209.405(a)--Reporting of        754 railroads....  2,400 reports....  30 minutes......  1,200 hours       92,928
 remedial actions--Completion
 of Form FRA F 6180.96
 including selection of
 railroad remedial action code.
    --(b) Violation report      754 railroads....  240 challenges...  45 minutes......          180       13,939
     challenge by the
     railroads--Remedial
     action reports.
209.407--Delayed reports......  754 railroads....  240 reports......  45 minutes......          180       13,939
                               ---------------------------------------------------------------------------------
        Total.................  32 States and 754  24,066 responses.  N/A.............       11,958      970,427
                                 railroads.
----------------------------------------------------------------------------------------------------------------
\1\ The current inventory exhibits a total burden of 9,346 hours while the total burden of this notice is 11,958
  hours.
\2\ For State respondents, the dollar equivalent cost is derived from the Bureau of Labor Statistics data for
  management occupations, NAICS 99920--State Government, excluding schools and hospitals, for State government
  employees. To calculate the mean hourly wage of $46.69 for this category of workers, FRA included a 75-percent
  charge for overhead costs. The calculation is $46.69 per hour * 1.75 = $81.71. The Web address for this data
  is: https://www.bls.gov/oes/current/naics4_999200.htm#11-0000. Additionally, for railroad respondents, the
  dollar equivalent cost is derived from the Surface Transportation Board's 2020 Full Year Wage A&B data series
  for railroad workers. The wage rate of $77.44 per hour includes a 75-percent overhead charge.

    Total Estimated Annual Responses: 24,066.
    Total Estimated Annual Burden: 11,958 hours.
    Total Estimated Annual Burden Hour Dollar Cost Equivalent:
$970,427.
    Under 44 U.S.C. 3507(a) and 5 CFR 1320.5(b) and 1320.8(b)(3)(vi),
FRA informs all interested parties that a respondent is not required to
respond to, conduct, or sponsor a collection of information that does
not display a currently valid OMB control number.
    Authority: 44 U.S.C. 3501-3520.

Brett A. Jortland,
Deputy Chief Counsel.
[FR Doc. 2022-02937 Filed 2-10-22; 8:45 am]
BILLING CODE 4910-06-P


[Federal Register Volume 79, Number 162 (Thursday, August 21, 2014)]
[Proposed Rules]
[Pages 49473-49474]
[FR Doc No: 2014-19517]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-RO1-OAR-2012-0848; A-1-FRL-9912-99-Region 1]

Approval and Promulgation of Air Quality Implementation Plans;
New Hampshire; Reasonably Available Control Technology for Nitrogen
Oxides and Volatile Organic Compounds

AGENCY: Environmental Protection Agency.

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve State Implementation Plan (SIP) revisions submitted by the
State of New Hampshire. These revisions contain an updated New
Hampshire regulation establishing reasonably available control
technology (RACT) for sources of nitrogen oxides (NOX), RACT
orders for four facilities, and a request to withdraw a previously
approved NOX RACT order from the SIP. The intended effect of
this action is to propose approval of this updated regulation and four
RACT orders into the New Hampshire SIP, and to propose to withdraw from
the SIP a previously approved NOX RACT order. This action is
being taken in accordance with the Clean Air Act.

DATES: Written comments must be received on or before September 22,
2014.

ADDRESSES: Submit your comments, identified by Docket ID No. RO1-OAR-
2012-0848 by one of the following methods:
    1. www.regulations.gov: Follow the on-line instructions for
submitting comments.
    2. E-Mail<EMAIL_ADDRESS>    3. Fax:<PHONE_NUMBER>.
    4. Mail: ``EPA-RO1-OAR-2012-0848,'' Anne Arnold, U.S. Environmental
Protection Agency, EPA New England Regional Office, 5 Post Office
Square--Suite 100, (Mail code OEP05-2), Boston, MA 02109-3912.
    5. Hand Delivery or Courier. Deliver your comments to: Anne Arnold,
Manager, Air Quality Planning Unit, Office of Ecosystem Protection,
U.S. Environmental Protection Agency, EPA New England Regional Office,
5 Post Office Square--Suite 100, (Mail code OEP05-2), Boston, MA 02109-
3912. Such deliveries are only accepted during the Regional Office's
normal hours of operation. The Regional Office's official hours of
business are Monday through Friday, 8:30 a.m. to 4:30 p.m., excluding
legal holidays.
    Please see the direct final rule which is located in the Rules
Section of this Federal Register for detailed instructions on how to
submit comments.

FOR FURTHER INFORMATION CONTACT: Bob McConnell, Air Quality Planning
Unit, U.S. Environmental Protection Agency, EPA New England Regional
Office, 5 Post Office Square, Suite 100 (mail code: OEP05-2), Boston,
MA 02109-3912, telephone number<PHONE_NUMBER>, fax number (617) 918-
0046, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In the Final Rules Section of this Federal
Register, EPA is approving the State's SIP submittal as a direct final
rule without prior proposal because the Agency views this as a
noncontroversial submittal and anticipates no adverse comments. A
detailed rationale for the approval is set forth in the direct final
rule. If no adverse comments are received in response to this action
rule, no further activity is contemplated. If EPA receives adverse
comments, the direct final rule will be withdrawn and all public
comments received will be addressed in a subsequent final rule based on
this proposed rule. EPA will not institute a second comment period. Any
parties interested in commenting on this action should 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.
    For additional information, see the direct final rule which is
located in the Rules Section of this Federal Register.

    Dated: July 29, 2014.
H. Curtis Spalding,
Regional Administrator, EPA New England.
[FR Doc. 2014-19517 Filed 8-20-14; 8:45 am]
BILLING CODE 6560-50-P


noncompliance was manufactured by a different manufacturer from the
reporting manufacturer, the reporting manufacturer shall identify the
component and, if known, the component's country of origin (i.e. final
place of manufacture or assembly), the manufacturer and/or assembler of
the component by name, business address, and business telephone number.
If the reporting manufacturer does not know the identity of the
manufacturer of the component, it shall identify the entity from which
it was obtained. If at the time of submission of the initial report,
the reporting manufacturer does not know the country of origin of the
component, the manufacturer shall ascertain the country of origin and
submit a supplemental report with that information once it becomes
available.
* * * * *

PART 579--REPORTING OF INFORMATION AND COMMUNICATIONS ABOUT
POTENTIAL DEFECTS

0
3. The authority citation for part 579 continues to read as follows:

    Authority: 49 U.S.C. 30102-103, 30112, 30117-121, 30166-167;
delegation of authority at 49 CFR 1.50 and 49 CFR 501.8.

Subpart A--General

0
4. Amend Sec.  579.4 by revising the definition of ``Other safety
campaign'' in paragraph (c) to read as follows:

Sec.  579.4  Terminology.

* * * * *
    (c) * * *
* * * * *
    Other safety campaign means an action in which a manufacturer
communicates with owners and/or dealers in a foreign country with
respect to conditions under which motor vehicles or equipment should be
operated, repaired, or replaced that relate to safety (excluding
promotional and marketing materials, customer satisfaction surveys, and
operating instructions or owner's manuals that accompany the vehicle or
child restraint system at the time of first sale); or advice or
direction to a dealer or distributor to cease the delivery or sale of
specified models of vehicles or equipment.
* * * * *

Subpart C--Reporting of Early Warning Information

0
5. Amend Sec.  579.21 by revising the section heading and by revising
the first sentence of the introductory text to read as follows:

Sec.  579.21  Reporting requirements for manufacturers of 5,000 or more
light vehicles annually.

    For each reporting period, a manufacturer whose aggregate number of
light vehicles manufactured for sale, sold, offered for sale,
introduced or delivered for introduction in interstate commerce, or
imported into the United States, during the calendar year of the
reporting period or during each of the prior two calendar years is
5,000 or more shall submit the information described in this section. *
* *
* * * * *

0
6. Amend Sec.  579.22 by
0
a. Revising the section heading;
0
b. Revising the introductory text; and
0
c. Revising the introductory text to paragraph (b) to read as follows:

Sec.  579.22  Reporting requirements for manufacturers of 100 or more
buses, manufacturers of 500 or more emergency vehicles and
manufacturers of 5,000 or more medium-heavy vehicles (other than buses
and emergency vehicles) annually.

    For each reporting period, a manufacturer whose aggregate number of
buses manufactured for sale, sold, offered for sale, introduced or
delivered for introduction in interstate commerce,

or imported into the United States, during the calendar year of the
reporting period or during either of the prior two calendar years is
100 or more shall submit the information described in this section. For
each reporting period, a manufacturer whose aggregate number of
emergency vehicles (ambulances and fire trucks) manufactured for sale,
sold, offered for sale, introduced or delivered for introduction in
interstate commerce, or imported into the United States, during the
calendar year of the reporting period or during either of the prior two
calendar years is 500 or more shall submit the information described in
this section. For each reporting period, a manufacturer whose aggregate
number of medium-heavy vehicles (a sum that does not include buses or
emergency vehicles) manufactured for sale, sold, offered for sale,
introduced or delivered for introduction in interstate commerce, or
imported into the United States, during the calendar year of the
reporting period or during either of the prior two calendar years is
5,000 or more shall submit the information described in this section.
For paragraphs (a) and (c) of this section, the manufacturer shall
submit information separately with respect to each make, model, and
model year of bus, emergency vehicle and/or medium-heavy vehicle
manufactured during the reporting period and the nine model years prior
to the earliest model year in the reporting period, including models no
longer in production.
* * * * *
    (b) Information on incidents involving death or injury. For all
buses, emergency vehicles and medium heavy vehicles manufactured during
a model year covered by the reporting period and the nine model years
prior to the earliest model year in the reporting period:
* * * * *

0
7. Amend Sec.  579.23 by revising the section heading and by revising
the first sentence of the introductory text to read as follows:

Sec.  579.23  Reporting requirements for manufacturers of 5,000 or more
motorcycles annually.

    For each reporting period, a manufacturer whose aggregate number of
motorcycles manufactured for sale, sold, offered for sale, introduced
or delivered for introduction in interstate commerce, or imported into
the United States, during the calendar year of the reporting period or
during either of the prior two calendar years is 5,000 or more shall
submit the information described in this section. * * *
* * * * *

0
8. Amend Sec.  579.24 by revising the section heading and by revising
the first sentence of the introductory text to read as follows:

Sec.  579.24  Reporting requirements for manufacturers of 5,000 or more
trailers annually.

    For each reporting period, a manufacturer whose aggregate number of
trailers manufactured for sale, sold, offered for sale, introduced or
delivered for introduction in interstate commerce, or imported into the
United States, during the calendar year of the reporting period or
during either of the prior two calendar years is 5,000 or more shall
submit the information described in this section. * * *
* * * * *

0
9. Amend Sec.  579.27 by revising the section heading to read as
follows:

Sec.  579.27  Reporting requirements for manufacturers of fewer than
100 buses annually, for manufacturers of fewer than 500 emergency
vehicles annually, for manufacturers of fewer than 5,000 light
vehicles, medium-heavy vehicles (other than buses and emergency
vehicles), motorcycles or trailers annually, for manufacturers of
original equipment, and for manufacturers of replacement equipment
other than child restraint systems and tires.

* * * * *

0
10. Amend Sec.  579.29 by adding paragraph (a)(3) to read as follows:

Sec.  579.29  Manner of reporting.

    (a) * * *
    (3) For each report required under paragraphs (a) through (c) of
Sec. Sec.  579.21 through 579.26 of this part and submitted in the
manner provided in paragraph (a)(1) of this section, a manufacturer
must state the make, model and model year of each motor vehicle or item
of motor vehicle equipment in terms that are identical to the statement
of the make, model, model year of each motor vehicle or item of motor
vehicle equipment provided in the manufacturer's previous report.
* * * * *

    Issued on: September 11, 2009.
Ronald L. Medford,
Acting Deputy Administrator.
[FR Doc. E9-22365 Filed 9-16-09; 8:45 am]

BILLING CODE 4910-59-P


[Federal Register Volume 78, Number 204 (Tuesday, October 22, 2013)]
[Notices]
[Pages 62613-62614]
[FR Doc No: 2013-24615]

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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: RP14-36-000.
    Applicants: Texas Eastern Transmission, LP.
    Description: PSEG ERT 11-01-2013 Negotiated Rate (TIME II) to be
effective 11/1/2013.
    Filed Date: 10/15/13.
    Accession Number: 20131015-5216.
    Comments Due: 5 p.m. ET 10/28/13.

    Docket Numbers: RP14-37-000.
    Applicants: Iroquois Gas Transmission System, L.P.
    Description: 10/15/13 Negotiated Rates--Barclays (RTS) 7055-33, 34,
36, 37, 39, 40, 41 & 42 to be effective 11/1/2013.
    Filed Date: 10/15/13.
    Accession Number: 20131015-5237.
    Comments Due: 5 p.m. ET 10/28/13.

    Docket Numbers: RP14-38-000.
    Applicants: Iroquois Gas Transmission System, L.P.
    Description: 10/15/13 Negotiated Rates--Cargill Incorporated (RTS)
3085-15 & 16 to be effective 11/1/2013.
    Filed Date: 10/15/13.
    Accession Number: 20131015-5238.
    Comments Due: 5 p.m. ET 10/28/13.

    Docket Numbers: RP14-39-000.
    Applicants: Iroquois Gas Transmission System, L.P.
    Description: 10/15/13 Negotiated Rates--Emera Energy Services, Inc.
(RTS) 2715-03 & 04 to be effective 11/1/2013.

    Filed Date: 10/15/13.
    Accession Number: 20131015-5239.
    Comments Due: 5 p.m. ET 10/28/13.

    Docket Numbers: RP14-40-000.
    Applicants: Iroquois Gas Transmission System, L.P.
    Description: 10/15/13 Negotiated Rates--JP Morgan Ventures Energy
Corp (RTS)--6025-26 to be effective 11/1/2013.
    Filed Date: 10/15/13.
    Accession Number: 20131015-5240.
    Comments Due: 5 p.m. ET 10/28/13.

    Docket Numbers: RP14-41-000.
    Applicants: Iroquois Gas Transmission System, L.P.
    Description: 10/15/13 Negotiated Rates--JP Morgan Ventures Energy
Corp (RTS)--6025-38 to be effective 11/1/2013.
    Filed Date: 10/15/13.
    Accession Number: 20131015-5277.
    Comments Due: 5 p.m. ET 10/28/13.

    Docket Numbers: RP14-42-000.
    Applicants: Iroquois Gas Transmission System, L.P.
    Description: Iroquois Gas Transmission System, L.P. submits tariff
filing per 154.204: 10/15/13 Negotiated Rates--Emera Energy Services,
Inc. (RTS) 2715-11 & 12 to be effective 11/1/2013.
    Filed Date: 10/15/13.
    Accession Number: 20131015-5397.
    Comments Due: 5 p.m. ET 10/28/13.

    Docket Numbers: RP14-43-000.
    Applicants: Tennessee Gas Pipeline Company, L.L.C.
    Description: Tennessee Gas Pipeline Company, L.L.C. submits tariff
filing per 154.204: Rate Schedule PAL Flexibility to be effective 11/
15/2013.
    Filed Date: 10/15/13.
    Accession Number: 20131015-5429.
    Comments Due: 5 p.m. ET 10/28/13.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR Sec.  385.211 and Sec.  385.214) on or
before 5:00 p.m. Eastern time on the specified comment date. Protests
may be considered, but intervention is necessary to become a party to
the proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: October 16, 2013.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2013-24615 Filed 10-21-13; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 78, Number 53 (Tuesday, March 19, 2013)]
[Notices]
[Page 16849]
[FR Doc No: 2013-06202]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[ Project No. 12778-004]

Fall Creek Hydro, LLC, Oregon; Notice of Availability of Draft
Environmental Assessment

    In accordance with the National Environmental Policy Act of 1969
and the Federal Energy Regulatory Commission's (Commission or FERC's)
regulations, 18 Code of Federal Regulations (CFR) Part 380 (Order No.
486, 52 FR 47,897), the Office of Energy Projects has reviewed the
application for an original license to construct the Fall Creek Dam
Hydroelectric Project and has prepared a draft environmental assessment
(EA). The proposed 10-megawatt project would be located on Fall Creek
in Lane County, Oregon, near the towns of Springfield and Eugene, at an
existing dam operated by the U.S. Army Corps of Engineers. The proposed
project, if licensed, would occupy a total of 6.53 acres of federal
land.
    The draft EA includes the staff's analysis of the potential
environmental effects of licensing the project and concludes that
licensing the project, with appropriate protective measures, would not
constitute a major federal action significantly affecting the quality
of the human environment.
    A copy of the draft EA is available for review at the Commission in
the Public Reference Room or may be viewed on the Commission's Web site
at 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. For assistance, contact FERC Online Support at
<EMAIL_ADDRESS>or toll-free number at 1-866-208-3676, or
for TTY,<PHONE_NUMBER>.
    You may also register online at www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filings and issuances
related to this or other pending projects. For assistance, contact FERC
Online Support.
    Any comments should be filed within 30 days from the date of this
notice. Comments may be filed electronically via the Internet. See 18
CFR 385.2001(a)(1)(iii) and the instructions on the Commission's web
site http://www.ferc.gov/doc-filing/efiling.asp. Commenters can submit
brief comments up to 6,000 characters, without prior registration,
using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact information at the
end of your comments. For assistance, please contact FERC Online
Support. Although the Commission strongly encourages electronic filing,
documents may also be paper-filed. To paper-file, mail an original and
seven copies to: Kimberly D. Bose, Secretary, Federal Energy Regulatory
Commission, 888 First Street NE., Washington, DC 20426. Please affix
``Fall Creek Dam Hydroelectric Project, Project No. 12778-004'' to all
comments.
    Please contact Lee Emery by telephone at<PHONE_NUMBER> or by email
at<EMAIL_ADDRESS>if you have any questions.

    Dated: March 12, 2013.
Kimberly D. Bose,
Secretary.
[FR Doc. 2013-06202 Filed 3-18-13; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 116 (Thursday, June 16, 2022)]
[Notices]
[Pages 36351-36353]
[FR Doc No: 2022-12939]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-95084; File No. SR-CBOE-2022-025]

Self-Regulatory Organizations; Cboe Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change To Amend
Its Fees Schedule

June 10, 2022.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on June 1, 2022, Cboe Exchange, Inc. (the ``Exchange'' or ``Cboe
Options'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by the Exchange. 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.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    Cboe Exchange, Inc. (the ``Exchange'' or ``Cboe Options'') proposes
to amend its Fees Schedule. The text of the proposed rule change is
provided in Exhibit 5.
    The text of the proposed rule change is also available on the
Exchange's website (http://www.cboe.com/AboutCBOE/CBOELegalRegulatoryHome.aspx), at the Exchange's Office of the
Secretary, 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, the Exchange 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. The Exchange 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
    The Exchange proposes to amend its Fees Schedule, effective June 1,
2022. Particularly, the Exchange proposes to amend fees relating to
Customer orders in OEX, OEX Weekly, XEO and XEO Weekly. Currently,
Customer orders in OEX and XEO yield fee code CO and are assessed a fee
of $0.40 per contract. Customer orders in OEX Weekly and XEO Weekly
yield fee code CP and are assessed a fee of $0.30 per contract. The
Exchange proposes now to apply a single rate for both monthly and
weekly OEX and XEO Customer orders. Specifically, the Exchange proposes
to assess $0.35 per contract for all OEX and XEO Customers orders,
which will each yield Fee Code CO going forward.\3\
---------------------------------------------------------------------------

    \3\ In light of the proposed change, the Exchange proposes to
eliminate the reference to Fee Code CP in the Rate Table--Underlying
Symbol List A table in the Fee Schedule. Fee Code CP will continue
to apply to Sector Indexes, which will continue to be reflected in
the Rate Table--All Products Excluding Underlying Symbol List A.
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
the Securities Exchange Act of 1934 (the ``Act'') and the rules and
regulations thereunder applicable to the Exchange and, in particular,
the requirements of Section 6(b) of the Act.\4\ Specifically, the
Exchange believes the proposed rule change is consistent with the
Section 6(b)(5) \5\ requirements that the rules of an exchange be
designed to prevent fraudulent and manipulative acts and practices, to
promote just and equitable principles of trade, to foster cooperation
and coordination with persons engaged in regulating, clearing,
settling, processing information with respect to,

and facilitating transactions in securities, to remove impediments to
and perfect the mechanism of a free and open market and a national
market system, and, in general, to protect investors and the public
interest. Additionally, the Exchange believes the proposed rule change
is consistent with Section 6(b)(4) of the Act,\6\ which requires that
Exchange rules provide for the equitable allocation of reasonable dues,
fees, and other charges among its Trading Permit Holders and other
persons using its facilities.
---------------------------------------------------------------------------

    \4\ 15 U.S.C. 78f(b).
    \5\ 15 U.S.C. 78f(b)(5).
    \6\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

    The Exchange believes that the proposed change is reasonable as the
proposed rate does not significantly deviate from the current rates
applicable to Customer orders in OEX, XEO, OEX Weekly or XEO Weekly.
The Exchange believes the proposed change is reasonable, equitable and
not unfairly discriminatory because the proposed rate will apply to all
Trading Permit Holders uniformly. Additionally, the proposed rate will
apply equally to all customer orders in OEX and XEO, regardless of
whether the orders are for monthly (OEX and XEO) or weekly (OEX Weekly
and XEO Weekly) expirations, which the Exchange believes will simplify
and streamline transaction fees for the underlying product. The
Exchange notes it assesses a single rate for both monthly and weekly
OEX and XEO orders for all other order capacities.\7\
---------------------------------------------------------------------------

    \7\ See Cboe Options Fees Schedule, Rate Table--Underlying
Symbol List A.
---------------------------------------------------------------------------

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

    The Exchange does not believe that the proposed rule change will
impose any burden on intramarket or intermarket competition that is not
necessary or appropriate in furtherance of the purposes of the Act. The
Exchange does not believe that the proposed rule change will impose any
burden on intramarket competition because the proposed change applies
uniformly to all Trading Permit Holders. The Exchange does not believe
that the proposed rule changes will impose any burden on intermarket
competition that is not necessary or appropriate in furtherance of the
purposes of the Act because the proposed changes apply only to products
traded exclusively on Cboe Options. Additionally, the Exchange notes
that it operates in a highly competitive market. TPHs have numerous
alternative venues that they may participate on and direct their order
flow, including 15 other options exchanges, as well as off-exchange
venues, where competitive products are available for trading. Based on
publicly available information, no single options exchange has more
than 16% of the market share.\8\ Therefore, no exchange possesses
significant pricing power in the execution of option order flow.
Indeed, participants can readily choose to send their orders to other
exchange, and, additionally off-exchange venues, if they deem fee
levels at those other venues to be more favorable. Moreover, the
Commission has repeatedly expressed its preference for competition over
regulatory intervention in determining prices, products, and services
in the securities markets. Specifically, in Regulation NMS, the
Commission highlighted the importance of market forces in determining
prices and SRO revenues and, also, recognized that current regulation
of the market system ``has been remarkably successful in promoting
market competition in its broader forms that are most important to
investors and listed companies.'' \9\ The fact that this market is
competitive has also long been recognized by the courts. In
NetCoalition v. Securities and Exchange Commission, the D.C. Circuit
stated as follows: ``[n]o one disputes that competition for order flow
is `fierce.' . . . As the SEC explained, `[i]n the U.S. national market
system, buyers and sellers of securities, and the broker-dealers that
act as their order-routing agents, have a wide range of choices of
where to route orders for execution'; [and] `no exchange can afford to
take its market share percentages for granted' because `no exchange
possesses a monopoly, regulatory or otherwise, in the execution of
order flow from broker dealers'. . . .''.\10\ Accordingly, the Exchange
does not believe its proposed fee change imposes any burden on
competition that is not necessary or appropriate in furtherance of the
purposes of the Act.
---------------------------------------------------------------------------

    \8\ See Cboe Global Markets U.S. Options Market Volume Summary,
Month-to-Date (May 31, 2022), available at https://www.cboe.com/us/options/market_statistics/.
    \9\ See Securities Exchange Act Release No. 51808 (June 9,
2005), 70 FR 37496, 37499 (June 29, 2005).
    \10\ NetCoalition v. SEC, 615 F.3d 525, 539 (DC Cir. 2010)
(quoting Securities Exchange Act Release No. 59039 (December 2,
2008), 73 FR 74770, 74782-83 (December 9, 2008) (SR-NYSEArca-2006-
21)).
---------------------------------------------------------------------------

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

    The Exchange neither solicited nor received comments on the
proposed rule change.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A) of the Act \11\ and paragraph (f) of Rule 19b-4 \12\
thereunder. At any time within 60 days of the filing of the proposed
rule change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission will institute proceedings to
determine whether the proposed rule change should be approved or
disapproved.
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78s(b)(3)(A).
    \12\ 17 CFR 240.19b-4(f).
---------------------------------------------------------------------------

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 email to [email protected]. Please include
File Number SR-CBOE-2022-025 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-CBOE-2022-025. This file
number should be included on the subject line if email 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 website (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 website 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 10:00 a.m. and 3:00 p.m. Copies of
the filing also will be available for inspection and copying at the
principal office of the Exchange. All comments received will be posted
without change.
    Persons submitting comments are cautioned that we do not redact or
edit personal identifying information from comment submissions. You
should submit only information that you wish to make available
publicly. All submissions should refer to File Number SR-CBOE-2022-025
and should be submitted on or before July 7, 2022.
---------------------------------------------------------------------------

    \13\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\13\
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2022-12939 Filed 6-15-22; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: April 11, 2006 (Volume 71, Number 69)]
[Notices]
[Page 18316]
[DOCID:fr11ap06-86]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. ER06-804-000, et al.]

Great Lakes Hydro America, LLC et al.; Electric Rate and
Corporate Filings

April 5, 2005.
    The following filings have been made with the Commission. The
filings are listed in ascending order within each docket
classification.

1. Great Lakes Hydro America, LLC

[Docket No. ER06-804-000]

    Take notice that on March 28, 2006, Great Lakes America, LLC filed
revisions to its Market-Base Rate Tariff, FERC Electric Tariff Second
Revised Volume No. 1, to completely update and modernize its Tariff.
    Comment Date: 5 p.m. Eastern Time on April 7, 2006.

2. Brookfield Energy Marketing Inc.

[Docket No. ER06-805-000]

    Take notice that on March 28, 2006, Brookfield Energy Marketing
Inc. filed revisions to its Market-Based Rate Tariff, FERC Electric
Tariff Original Volume No. 1, to completely update and modernize its
Tariff.
    Comment Date: 5 p.m. Eastern Time on April 7, 2006.

Standard Paragraph

    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date. On or
before the comment date, it is not necessary to serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible online at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
 [FR Doc. E6-5321 Filed 4-10-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 84, Number 125 (Friday, June 28, 2019)]
[Rules and Regulations]
[Pages 30918-30920]
[FR Doc No: 2019-13738]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R06-OAR-2016-0619; FRL-9995-36-Region 6]

Air Plan Approval; Oklahoma; Regional Haze Five-Year Progress
Report

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: Pursuant to the Federal Clean Air Act (CAA or the Act), the
Environmental Protection Agency (EPA) is approving a revision to a
State Implementation Plan (SIP) submitted by the Governor of Oklahoma
through the Oklahoma Department of Environmental Quality (ODEQ) on
September 28, 2016. The SIP revision addresses requirements of federal
regulations that direct the State to submit a periodic report
describing progress toward reasonable progress goals (RPGs) established
for regional haze and a determination of the adequacy of the existing
implementation plan.

DATES: This rule is effective July 29, 2019.

ADDRESSES: The EPA has established a docket for this action under
Docket ID No. EPA-R06-OAR-2016-0619. All documents listed in the docket
are listed on the https://www.regulations.gov website. Although listed
in the index, some information may not be publicly available, i.e.,
Confidential Business Information 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 www.regulations.gov or in hard
copy at the EPA Region 6 Office, 1201 Elm Street, Dallas, TX 75270.

FOR FURTHER INFORMATION CONTACT: Clovis Steib, EPA Region 6 Office,
Regional Haze & SO2 Section, 1201 Elm Street, Suite 500,
Dallas, TX 75270,<PHONE_NUMBER><EMAIL_ADDRESS>To inspect the
hard copy materials, please schedule an appointment with Mr. Bill Deese
at<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Throughout this document ``we,'' ``us,'' or
``our'' means the EPA.

I. Background

    In a notice of proposed rulemaking (NPRM) published on March 28,
2019 (84 FR 11711), EPA proposed to approve Oklahoma's (the State's)
Regional Haze Five Year Progress Report.\1\ On September 28, 2016,
Oklahoma submitted its progress report in the form of a SIP revision
under 40 CFR 51.308, which, among other things, detailed the progress
made in the first planning period toward implementation of the long-
term strategy (LTS) outlined in the State's regional haze plan. The
progress report also included a summary of the visibility improvement
measured at the Wichita Mountains Wilderness Area (WMWA), the only
Class I area within Oklahoma, an assessment of whether Class I areas
outside of the State are potentially impacted by emissions from
Oklahoma, and a determination of the adequacy of the existing
implementation plan. The details of Oklahoma's submittal and the
rationale for EPA's action are further explained in the NPRM. EPA did
not receive any relevant adverse comments on the proposed action. We
received one comment letter from the Texas Commission on Environmental
Quality (TCEQ) that discussed issues outside the scope of this
particular rule making.\2\
---------------------------------------------------------------------------

    \1\ Oklahoma's submitted report can be found at
www.regulations.gov; Docket EPA-R06-OAR-2016-0619-0002.
    \2\ The TCEQ submitted a letter commenting on the remanded 2016
Federal Implementation Plan (FIP) for Texas regarding regional haze
reasonable progress, urging EPA to repeal the FIP in its entirety;
as well as act on and approve the State's own 2014 Regional Haze
Five-Year Progress Report and finalize any action resulting from the
additional comment period on the 2017 FIP for the State regarding
regional haze Best Available Retrofit Technology (BART). This letter
can be found at www.regulations.gov; Docket EPA-R06-OAR-2016-0619-
0004. EPA is addressing regional haze requirements for Texas in
another action; see Dockets EPA-R06-OAR-2014-0754 and EPA-R06-OAR-
2016-0611.
---------------------------------------------------------------------------

II. Final Action

    EPA is approving Oklahoma's regional haze five-year progress report
SIP revision, finding it meets the applicable regional haze
requirements under the CAA and set forth in 40 CFR 51.308(g), (h) and
(i). Because the SIP

and Federal Implementation Plan (FIP) \3\ will ensure the control of
SO2 and NOX emissions reductions relied upon by
Oklahoma and other states in setting their reasonable progress goals,
EPA concurs with the State's finding that there is no need for revision
of the existing implementation plan to achieve the reasonable progress
goals for the Class I areas in Oklahoma and in nearby states impacted
by Oklahoma sources.
---------------------------------------------------------------------------

    \3\ As discussed in the NPRM, EPA issued a FIP, promulgating
revised SO2 Best Available Retrofit Technology (BART)
emission limits on six-coal-fired EGUs located at three facilities.
(See 76 FR 81728 (December 28, 2011), codified at 40 CFR 52.1923)
The FIP affects two units at each of two facilities owned and
operated by Oklahoma Gas and Electric Company (OG&E): Muskogee
Generating Station in Muskogee County, and Sooner Generating Station
in Noble County. The FIP also initially applied to two units at
American Electric Power/Public Service Company of Oklahoma's (AEP/
PSO's) Northeastern Power Station in Rogers County, but those
requirements have since been removed from the FIP after EPA approval
of a SIP revision addressing these two units.
---------------------------------------------------------------------------

III. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
federal regulations. See 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 approves a State's determination that their current regional
haze plan is 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 Orders
12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21,
2011);
     Is not an Executive Order 13771 regulatory action because
SIP approvals are exempted under Executive Order 12866;
     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, the SIP is not approved to apply on any Indian
reservation land or in any other area where EPA or an Indian tribe has
demonstrated that a tribe has jurisdiction. In those areas of Indian
country, the proposed rule does not have tribal implications and will
not impose substantial direct costs on tribal governments or preempt
tribal law as specified by Executive Order 13175 (65 FR 67249, November
9, 2000).
    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).
    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 August 27, 2019. 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, Best Available
Retrofit Technology, Incorporation by reference, Intergovernmental
relations, Nitrogen dioxide, Ozone, Particulate matter, Reporting and
recordkeeping requirements, Regional haze, Sulfur dioxide, Visibility,
Volatile organic compounds.

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

    Dated: June 24, 2019.
David Gray,
Acting 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 LL--Oklahoma

0
2. In Sec.  52.1920, under paragraph (e), the first table titled ``EPA-
Approved Nonregulatory Provisions and Quasi-Regulatory Measures in the
Oklahoma SIP'' is amended by adding an entry at the end to read as
follows:

Sec.  52.1920  Identification of plan.

* * * * *
    (e) * * *

                                 EPA Approved Nonregulatory Provisions and Quasi-Regulatory Measures in the Oklahoma SIP
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                        Applicable
      Name of SIP provision            geographic or       State submittal              EPA approval date                        Explanation
                                    nonattainment area           date
--------------------------------------------------------------------------------------------------------------------------------------------------------

                                                                      * * * * * * *
Oklahoma Regional Haze 5-Year      Statewide...........  Submitted 9/28/16..  6/28/19, [Insert Federal Register
 Progress Report.                                                              citation].
--------------------------------------------------------------------------------------------------------------------------------------------------------

[FR Doc. 2019-13738 Filed 6-27-19; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register: July 13, 2010 (Volume 75, Number 133)]
[Notices]
[Page 40021-40023]
[DOCID:fr13jy10-135]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket No. FRA 2010-0005-N-17]

Agency Information Collection Activities; Comment Request

AGENCY: Federal Railroad Administration, DOT.

ACTION: Notice.

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

SUMMARY: In accordance with the Paperwork Reduction Act of 1995 and its
implementing regulations, the Federal Railroad Administration (FRA)
hereby announces that it is seeking renewal of the following
information collection activities that were previously approved by OMB.
Before submitting these information collection requirements for
clearance by the Office of Management and Budget (OMB), FRA is
soliciting public comment on specific aspects of the activities
identified below.

DATES: Comments must be received no later than September 13, 2010.

ADDRESSES: Submit written comments on any or all of the following
proposed activities by mail to either: Mr. Robert Brogan, Office of
Safety, RRS-21, Federal Railroad Administration, 1200 New Jersey Ave.,
SE., Mail Stop 17, Washington, DC 20590, or Ms. Kimberly Toone, Office
of Information Technology, RAD-20, Federal Railroad Administration,
1200 New Jersey Ave., SE., Mail Stop 35, Washington, DC 20590.
Commenters requesting FRA to acknowledge receipt of their respective
comments must include a self-addressed stamped postcard stating,
``Comments on OMB control number 2130---------.'' Alternatively,
comments may be transmitted via facsimile to<PHONE_NUMBER> or (202)
493-6497, or via e-mail to Mr. Brogan at<EMAIL_ADDRESS>or to
Ms. Toone at<EMAIL_ADDRESS>Please refer to the assigned OMB
control number and the title of the information collection in any
correspondence submitted. FRA will summarize comments received in
response to this notice in a subsequent notice and include them in its
information collection submission to OMB for approval.

FOR FURTHER INFORMATION CONTACT: Mr. Robert Brogan, Office of Safety,
RRS-21, Federal Railroad Administration, 1200 New Jersey Ave., SE.,
Mail Stop 17, Washington, DC 20590 (telephone:<PHONE_NUMBER>) or Ms.
Kimberly Toone, Office of Information Technology, RAD-20, Federal
Railroad Administration, 1200 New Jersey Ave., SE., Mail Stop 35,
Washington, DC 20590 (telephone:<PHONE_NUMBER>). (These telephone
numbers are not toll-free.)

SUPPLEMENTARY INFORMATION: The Paperwork Reduction Act of 1995 (PRA),
Public Law 104-13, section 2, 109 Stat. 163 (1995) (codified as revised
at 44 U.S.C. 3501-3520), and its implementing regulations, 5 CFR Part
1320, require Federal agencies to provide 60-days notice to the public
for comment on information collection activities before seeking
approval of such activities by OMB. 44 U.S.C. 3506(c)(2)(A); 5 CFR
1320.8(d)(1), 1320.10(e)(1), 1320.12(a). Specifically, FRA invites
interested respondents to comment on the following summary of proposed
information collection activities regarding (i) whether the information
collection activities are necessary for FRA to properly execute its
functions, including whether the activities will have practical
utility; (ii) the accuracy of FRA's estimates of the burden of the
information collection activities, including the validity of the
methodology and assumptions used to determine the estimates; (iii) ways
for FRA to enhance the quality, utility, and clarity of the information
being collected; and (iv) ways for FRA to minimize the burden of
information collection activities on the public by automated,
electronic, mechanical, or other technological collection techniques or
other forms of information technology (e.g., permitting electronic
submission of responses). See 44 U.S.C. 3506(c)(2)(A)(I)-(iv); 5 CFR
1320.8(d)(1)(I)-(iv). FRA believes that soliciting public comment will
promote its efforts to reduce the administrative and paperwork burdens
associated with the collection of information mandated by Federal
regulations. In summary, FRA reasons that comments received will
advance three objectives: (i) Reduce reporting burdens; (ii) ensure
that it organizes information collection requirements in a ``user
friendly'' format to improve the use of such information; and (iii)
accurately assess the resources expended to retrieve and produce
information requested. See 44 U.S.C. 3501.
    Below is a brief summary of the information collection activities
that FRA will submit for renewed clearance by OMB as required under the
PRA:
    Title: Causal Analysis and Countermeasures to Reduce Rail-related
Suicides.
    OMB Control Number: 2130-0572.
    Abstract: Pedestrian trespassing on railroad property resulting in
serious injury or death is one of the two most serious safety problems
(the second being grade crossing collisions) facing the railroad
industry and its regulators not only in the United States but also in
other countries. It is widely believed in this country that the
reported prevalence and incidence of railway suicide vastly under-
represents the nature and extent of the problem. There is no central
reporting system within the railroad industry or the suicide prevention
field that provides verifiable information about how many trespass
deaths are accidental vs. intentional. Therefore, there are no
verifiable measures of the extent of rail-related suicides in the
United States.
    While railroad companies must report trespass incidents resulting
in serious injury or death to the U.S. Federal Railroad Administration
(FRA), injuries or deaths that are ruled by a medical examiner or
coroner to be intentional are not reported. Preliminary figures from
2006 indicate there were approximately 500 deaths and 360 injuries
reported to the FRA--an increase of 100 incidents over the previous
year--but suicides are not represented in these numbers. Unverifiable
estimates from a number of sources range from 150 to more than 300
suicides per year on the U.S. railways.
    Like any other incident on the rail system, a suicide on the tracks
results in equipment and facility damage, delays to train schedules,
and trauma to railroad personnel involved in the incidents. As a
result, FRA last year awarded a grant for the first phase of a 5-year
project to reduce suicides on the rail system to the Railroad Research
Foundation (part of the Association of American Railroads) and its
subcontractor, the American Association of Suicidology (AAS).
    In the course of five years, the research project's goals include:
     A prevalence assessment to determine verifiable numbers of
suicides on the rail system,
     Development of a standardized reporting tool for industry
use,
     A causal analysis and root cause analysis of suicide
incidents that occur during the grant cycle, and

     Design and implementation of suicide prevention measures
for the nation's rail system to reduce suicide injuries and deaths.
    This request to the Office of Management and Budget is for re-
approval in order to complete Phase II of the project, the causal
analysis. In order to understand as much as possible about people who
intend to die by placing themselves in the path of a train, and
therefore to design prevention strategies, AAS has been conducting 60
psychological autopsies over the course of two years on people who die
by rail-related suicide.
    Psychological autopsy is a recognized and accepted method for
obtaining information about physical, emotional and circumstantial
contributors to a person's death. The 60 psychological autopsies for
the FRA project involve interviews with informants to these incidents
including family members and friends, employers and co-workers, and
rail personnel involved in the incidents.
    After conducting a root cause analysis of this data, AAS will then
work with the industry to design, pilot test and implement effective
countermeasures with the goal of reducing deaths, injuries and
psychological trauma.
    Form Number(s): FRA F 6180.125A; FRA F 6180.125B.
    Affected Public: Individuals.
    Respondent Universe: 280 Railroad Personnel/Members of the Public/
Affected Families and Friends.
    Frequency of Submission: On occasion.
    Reporting Burden:

----------------------------------------------------------------------------------------------------------------
                                                        Total annual      Average time per   Total annual burden
     Collection instrument       Respondent universe      responses           response              hours
----------------------------------------------------------------------------------------------------------------
Form FRA F 6180.125A..........  280 Individuals.....  5,600 responses/  5 minutes..........  467 hours.
                                                      forms...........
Form FRA F 6180.125B..........  280 Individuals.....  35 forms........  2 hours............  70 hours.
----------------------------------------------------------------------------------------------------------------

    Total Responses: 5,670.
    Estimated Total Annual Burden: 537 hours.
    Status: Re-Approval under Regular Clearance Procedures.
    Title: Confidential Close Call Reporting System Evaluation-Related
Interview Data Collection.
    OMB Control Number: 2130-0574.
    Abstract: In the U.S. railroad industry, injury rates have been
declining over the last 25 years. Indeed, the industry incident rate
fell from a high of 12.1 incidents per 100 workers per year in 1978 to
3.66 in 1996. As the number of incidents has decreased, the mix of
causes has also changed toward a higher proportion of incidents that
can be attributed to human and organizational factors. This combination
of trends--decrease in overall rates but increasing proportion of human
factors-related incidents--has left safety managers with a need to
shift tactics in reducing injuries to even lower rates than they are
now.
    In recognition of the need for new approaches to improving safety,
FRA has instituted the Confidential Close Call Reporting System
(C\3\RS). The operating assumption behind C\3\RS is that by assuring
confidentiality, employees will report events which, if dealt with,
will decrease the likelihood of accidents. C\3\RS, therefore, has both
a confidential reporting component, and a problem analysis/solution
component. C\3\RS is expected to affect safety in two ways. First, it
will lead to problem solving concerning specific safety conditions.
Second, it will engender an organizational culture and climate that
supports greater awareness of safety and a greater cooperative
willingness to improve safety.
    If C\3\RS works as intended, it could have an important impact on
improving safety and safety culture in the railroad industry. While
C\3\RS has been developed and implemented with the participation of
FRA, railroad labor, and railroad management, there are legitimate
questions about whether it is being implemented in the most beneficial
way, and whether it will have its intended effect. Further, even if
C\3\RS is successful, it will be necessary to know if it is successful
enough to implement on a wide scale. To address these important
questions, FRA is implementing a formative evaluation to guide program
development, a summative evaluation to assess impact, and a
sustainability evaluation to determine how C\3\RS can continue after
the test period is over. The evaluation is needed to provide FRA with
guidance as to how it can improve the program, and how it might be
scaled up throughout the railroad industry.
    Program evaluation is an inherently data driven activity. Its basic
tenet is that as change is implemented, data can be collected to track
the course and consequences of the change. Because of the setting in
which C\3\RS is being implemented, that data must come from the
railroad employees (labor and management) who may be affected. Critical
data include beliefs about safety and issues related to safety, and
opinions/observations about the operation of C\3\RS.
    The current study is a five-year demonstration project to improve
rail safety, and is designed to identify safety issues and propose
corrective action based on voluntary reports of close calls submitted
to the Bureau of Transportation Statistics. Because of the innovative
nature of this program, FRA is implementing an evaluation to determine
whether the program is succeeding, how it can be improved and, if
successful, what is needed to spread the program throughout the
railroad industry. Interviews to evaluate the close call reporting
system are being conducted with two groups: (1) Key stakeholders to the
process (e.g., FRA officials, industry labor, and carrier management
within participating railroads); and (2) Employees in participating
railroads who are eligible to submit close call reports to the
Confidential Close Call Reporting System. Different questions are
addressed to each of these two groups. Interviews are semi-structured,
with follow-up questions asked as appropriate depending on the
respondent's initial answer.
    The confidentiality of the interview data is protected by the
Privacy Act of 1974. FRA fully complies with all laws pertaining to
confidentiality, including the Privacy Act. Thus, information obtained
by or acquired by FRA's contractor, the Volpe Center, from key
stakeholders and railroad employees will be used strictly for
evaluation purposes. None of the information that might be identifying
will be disseminated or disclosed in any way. In addition, the
participating railroad sites involved will require Volpe to establish a
non-disclosure agreement that prohibits disclosure of company
confidential information without the carrier's authorization. Also, the
data is protected under the Department of Transportation regulation
Title 49 CFR Part 9, which is in part concerned with the Department
involvement in proceedings between private litigants. According to this
statute, if information is subpoenaed, Volpe and Volpe

contractors cannot ``provide testimony or produce any material
contained in the files of the Department, or disclose any information
or produce any material acquired as part of the performance of that
employee's official duties or because of that employee's official duty
status'' unless authorized by agency counsel after determining that, in
legal proceedings between private litigants, such testimony would be in
the best interests of the Department or that of the United States
Government if disclosed. Finally, the name of those interviewed will
not be requested.
    Form Number(s): FRA F 6180.126A; FRA F 6180.126B.
    Affected Public: Railroad Employees and Key Non-railroad
Stakeholders.
    Respondent Universe: 300 Select Railroad Employees/Non-railroad
Stakeholders.
    Frequency of Submission: On occasion.

----------------------------------------------------------------------------------------------------------------
                                                        Total annual       Average time per      Total annual
    Collection instrument      Respondent universe       responses             response          burden hours
----------------------------------------------------------------------------------------------------------------
Form FRA F 6180.126A.........  300 Individuals....  133.5 forms........  60 minutes.........  133.5 hours.
Form FRA F 6180.126B.........  300 Individuals....  133.5 forms........  60 minutes.........  133.5 hours.
----------------------------------------------------------------------------------------------------------------

    Total Responses: 267.
    Estimated Annual Burden: 267 hours.
    Status: Re-Approval under Regular Clearance Procedures.
    Pursuant to 44 U.S.C. 3507(a) and 5 CFR 1320.5(b),
1320.8(b)(3)(vi), FRA informs all interested parties that it may not
conduct or sponsor, and a respondent is not required to respond to, a
collection of information unless it displays a currently valid OMB
control number.

    Authority:  44 U.S.C. 3501-3520.

    Issued in Washington, DC, on July 7, 2010.
Kimberly Coronel,
Director, Office of Financial Management, Federal Railroad
Administration.
[FR Doc. 2010-17017 Filed 7-12-10; 8:45 am]
BILLING CODE 4910-06-P