[Federal Register Volume 78, Number 120 (Friday, June 21, 2013)]
[Notices]
[Pages 37653-37656]
[FR Doc No: 2013-14896]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

Notice of Fiscal Year (FY) 2014 Safety Grants and Solicitation
for Applications

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice; announcement of grant opportunities and application due
dates.

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SUMMARY: FMCSA announces the availability of FY 2014 safety grant
opportunities and application due dates. Available grants include: the
Motor Carrier Safety Assistance Program (MCSAP) Basic and Incentive
grants; MCSAP New Entrant Safety Audit grants; MCSAP High Priority
grants; Border Enforcement Grants (BEG); Commercial Driver's License
Program Implementation (CDLPI) grants; Commercial Vehicle Information
Systems and Networks (CVISN) grants; Safety Data Improvement Program
(SaDIP) grants; Performance and Registration Information Systems
Management (PRISM) grants; and Commercial Motor Vehicle (CMV) Operator
Safety Training grants. These grant opportunities are authorized by the
Safe, Accountable, Flexible, Efficient Transportation Equity Act: A
Legacy for Users (SAFETEA-LU), as amended by the Moving Ahead for
Progress in the 21st Century Act (MAP-21).

DATES: Application deadlines are as follows: MCSAP Basic and Incentive
grants--August 1, 2013; Border Enforcement grants--August 12, 2013;
MCSAP New Entrant Safety Audit grants--August 26, 2013; MCSAP High
Priority grants--September 9, 2013; CDLPI grants--January 13, 2014;
CVISN grants--January 13, 2014; SaDIP grants--January 21, 2014; PRISM
grants--January 27, 2014; CMV Operator Safety Training grants--February
3, 2014. Final dates will be published on the Federal Web site for
discretionary grants, Grants.gov. If additional funding is available,
the Agency may consider applications and plans submitted after the
final due dates on a case-by-case basis.

FOR FURTHER INFORMATION CONTACT: The FMCSA Grant Management Help Desk
at<EMAIL_ADDRESS>by telephone at<PHONE_NUMBER>, or
by mail at FMCSA, 1200 New Jersey Avenue SE., Washington, DC 20590.
Office hours are from 9 a.m. to 5 p.m., ET, Monday through Friday,
except Federal holidays.

SUPPLEMENTARY INFORMATION:

Background and Purpose

    For each grant program, FMCSA will post a Notice of Funding
Availability (NOFA) at Grants.gov. The NOFA will provide specific
information on: the application process; national program priorities
for FY 2014; evaluation criteria; required documents and
certifications; grantee matching share; maintenance-of-expenditure
requirements, if applicable; and additional information related to the
availability of funds. The Agency also provides information on FMCSA
grants and application procedures on its Web site at http://
www.fmcsa.dot.gov/about/

GRANTS/financial-assistance.aspx. General information about these
grants appears in the section of this notice titled ``Fiscal Year 2014
Safety Grants.''
    To ensure timely review and award of all grants, applications must
be submitted in accordance with the instructions in the NOFA for the
specific grant requested and include all required information and
attachments. FMCSA strongly encourages timely, complete applications,
and may reject applications that are late, incomplete or lacking
required attachments.

Fiscal Year 2014 Safety Grants

MCSAP Basic and Incentive Grants

    Sections 4101(a) and 4106 of SAFETEA-LU, [Pub. L. 109-59, 119 Stat.
1144 (August 10, 2005)], as amended by secs. 32601 and 32603(a) of MAP-
21 [Pub. L. 112-141, 126 Stat. 405, (July 6, 2012)] authorize FMCSA
MCSAP grants. The goal of MCSAP Basic and Incentive grants is to
develop and implement programs to improve CMV safety and reduce the
number and severity of crashes and hazardous materials incidents
involving CMVs through consistent, uniform, and effective CMV safety
programs.
    The FMCSA will reimburse each recipient no more than 80 percent of
eligible costs incurred in carrying out approved projects from the
State's Commercial Vehicle Safety Plan (CVSP); the recipient must
provide 20 percent in matching funds. The FMCSA Administrator waives
the matching funds requirement for the Virgin Islands, American Samoa,
Guam, and the Commonwealth of the Northern Mariana Islands. (See 49 CFR
350.305).
    Under the Basic and Incentive grant programs, a State lead agency
for administering the CVSP, as designated by its Governor, (MCSAP lead
agency) is eligible to apply for MCSAP Basic and Incentive grant
funding by submitting an application in response to the NOFA. See 49
CFR 350.201, 350.205, and 350.213. In accordance with 49 CFR 350.323,
the MCSAP Basic grant funds will be distributed proportionally to each
State's lead MCSAP agency using the following four, equally weighted
(25 percent) factors:
    (1) 1997 road miles (all highways) as defined by the FMCSA;
    (2) All vehicle miles traveled (VMT) as defined by the FMCSA;
    (3) Population--annual census estimates as issued by the U.S.
Census Bureau; and
    (4) Special fuel consumption (net after reciprocity adjustment) as
defined by the FMCSA.
    A State's lead MCSAP agency also may qualify for Incentive Funds if
FMCSA determines that the State's CMV safety program has shown
improvement in any or all of the following five categories:
    (1) Reduction in the number of large truck-involved fatal crashes;
    (2) Reduction in the rate of large truck-involved fatal crashes or
maintenance of a large truck-involved fatal crash rate that is among
the lowest 10 percent of such rates of MCSAP recipients;
    (3) Upload of CMV crash reports in accordance with current FMCSA
policy guidelines;
    (4) Verification of Commercial Driver's Licenses (CDL) during all
roadside inspections; or
    (5) Upload of CMV inspection data in accordance with current FMCSA
policy guidelines.
    The FMCSA calculates the amount of Basic and Incentive funding each
State is to receive. This information is provided to the States and is
made available on the Agency's Web site. The projected FY 2014
distribution is available at http://www.fmcsa.dot.gov/safety-security/safety-initiatives/mcsap/mcsapforms.htm. The amount indicated is based
on FY 2013 estimated awards and includes Incentive funding. State
distributions for FY 2014 may be impacted by the total amount
appropriated in FY 2014 and variations in the factors for both the
Basic and Incentive formulae. The MCSAP Basic and Incentive formula
grants are awarded based on FMCSA's approval of the State's CVSP.
Therefore, the evaluation factors for discretionary grant programs
described in the section of this notice titled ``Evaluation Factors''
are not applicable.

Border Enforcement Grants

    Sections 4101(c)(2) and 4110 of SAFETEA-LU, as amended by secs.
32603(c) and 32603(h) of MAP-21, authorize the Border Enforcement Grant
(BEG) program. The goal of the program is to increase and enhance
inspections of CMVs entering the United States. Additionally, the BEG
program funds are utilized to ensure motor carriers operating CMVs
entering the U.S. from a foreign country are in compliance with
commercial vehicle safety standards and regulations, financial
responsibility regulations and registration requirements of the U.S.
and to ensure drivers of those vehicles are qualified and properly
licensed to operate a CMV.
    The FMCSA will reimburse each recipient 100 percent of eligible
costs incurred in carrying out approved projects. Eligible applicants
include State governments or entities within States that share a land
border with Canada or Mexico that can carry out border CMV safety
programs and related enforcement activities and projects. FMCSA
encourages local government agencies to coordinate their applications
with the State lead CMV inspection agency to prevent redundancy.
Applications must include a Border Enforcement Plan.

New Entrant Safety Audit Grants

    Section 4107(b) of SAFETEA-LU, amended by SAFETEA-LU Technical
Corrections Act of 2008 [Pub. L. 110-244, sec. 301(b), 122 Stat. 1572,
1616 (June 6, 2008)], and as amended by sec. 32603(e) of MAP-21,
authorizes the New Entrant Safety Audit grant program. The goal of the
MCSAP New Entrant Safety Audit grant is to reduce CMV-involved crashes,
fatalities, and injuries by reviewing new interstate motor carriers to
ensure that they have effective safety management programs. Recipients
may use these funds for salaries and related expenses of New Entrant
auditors, including training and equipment, and to perform other
eligible activities that are directly related to conducting safety
audits.
    The FMCSA will reimburse each recipient 100 percent of eligible
costs incurred in carrying out approved projects. State and local
governments are eligible for New Entrant Safety Audit grants.

MCSAP High Priority Grants

    Section 4107(a) of SAFETEA-LU, amended by secs. 4101(a) and 4107 of
the SAFETEA-LU Technical Corrections Act of 2008, as amended by secs.
32603(a) and 32603(d) of MAP-21, authorizes the MCSAP High Priority
grant program. The goals of the MCSAP High Priority grant program are
to implement, promote, and maintain national programs to improve CMV
safety; increase compliance with CMV safety regulations; increase
public awareness about CMV safety; provide education on CMV safety and
related issues; and demonstrate new safety-related technologies.
    The FMCSA will reimburse each recipient 100 percent of eligible
costs incurred in carrying out approved projects related to public
education and outreach activities. FMCSA will reimburse each grantee 80
percent of eligible costs incurred in carrying out approved projects
related to all other activities; the recipient must provide 20 percent
in matching funds for these activities. Eligible applicants are State
agencies, local governments, and organizations representing government
agencies that use and train qualified

officers and employees in coordination with State motor vehicle safety
agencies. Participation of local law enforcement agencies is
encouraged. When the NOFA is posted on Grants.gov, interested local law
enforcement agencies should carefully review it for information about
special considerations and application review processes.
    Examples of High Priority activities include innovative traffic
enforcement projects with particular emphasis on texting and hand-held
cell phone prohibitions, work zone enforcement, rural road safety, and
innovative traffic enforcement initiatives such as high-visibility
traffic enforcement programs to promote safe driving behaviors among
car and truck drivers.

CDLPI Grants

    Sections 4101(c)(1) and 4124 of SAFETEA-LU, as amended by secs.
32603(c) and 32604 of MAP-21, authorize the CDLPI grant program. The
goal of CDLPI grants is to improve highway safety by ensuring that
States comply with the Federal regulations that require drivers of
large trucks and buses to be qualified to obtain and hold the CDL
necessary to operate those vehicles.
    The FMCSA will reimburse each recipient 100 percent of eligible
costs incurred in carrying out approved projects. Eligible applicants
for CDLPI grants include the agency designated by each State as having
the primary driver licensing responsibility, including development,
implementation, and maintenance of the CDL program. State agencies,
local governments, and other entities that can support a State's effort
to improve its CDL program, or conduct projects on a national scale to
improve the national CDL program, may also apply for projects under the
High Priority and Emerging Issues component of this grant. Priority
will be given to proposals that help States comply with 49 CFR parts
383 and 384, with specific emphasis on correcting previously identified
areas of noncompliance.

CVISN Grants

    Sections 4101(c)(4) and 4126 of SAFETEA-LU, as amended by secs.
32603(c) and 32605 of MAP-21, authorize the CVISN grant program. The
goal of CVISN grants is to advance the technological capability of
Intelligent Transportation System applications for CMV operations,
including vehicle, commercial driver, and carrier-specific information
systems and networks.
    The FMCSA will reimburse each recipient 50 percent of eligible
costs incurred in carrying out approved projects; the recipient must
provide 50 percent in matching funds for these activities. The agency
in each State designated as the primary agency responsible for the
development, implementation, and maintenance of the CVISN-related
systems is eligible to apply for grant funding.
    Section 4126 of SAFETEA-LU establishes two types of CVISN projects:
Core and Expanded. To be eligible for funding of Core CVISN deployment
project(s), a State must have its most current Core CVISN Program Plan
and Top-Level Design approved by FMCSA and the proposed project(s)
should be consistent with its approved Core CVISN Program Plan and Top-
Level Design. A State without an FMCSA-approved Core CVISN Program Plan
and Top-Level Design may apply for funds to create one or to update an
existing CVISN Program Plan and Top-Level Design.
    A State may also apply for funds to prepare an Expanded CVISN
Program Plan and Top-Level Design if FMCSA acknowledged the staff as
having completed Core CVISN deployment. In order to be eligible for
funding of any Expanded CVISN deployment project(s), a State must have
its most current Expanded CVISN Program Plan and Top-Level Design
approved by FMCSA and any proposed Expanded CVISN project(s) should be
consistent with its Expanded CVISN Program Plan and Top-Level Design. A
State without an FMCSA-approved Expanded CVISN Program Plan and Top-
Level Design may apply for funds to create one or to update an existing
Expanded CVISN Program Plan and Top-Level Design.
    The maximum core deployment grant funding that FMCSA may award a
State is an aggregate total of $2.5 million in CVISN Core funding
across all fiscal years. The maximum expanded deployment grant that
FMCSA may award a State in any fiscal year is $1 million. After FMCSA
has awarded grants for the Core Deployment of CVISN, FMCSA will then
use the remaining CVISN funds for proposals for the Expanded
Deployment.

SaDIP Grants

    Sections 4101(c)(5) and 4128 of SAFETEA-LU, as amended by sec
32603(c) of MAP-21, authorize Safety Data Improvement Program (SaDIP)
grants. The goal of SaDIP grants is to improve the timeliness,
efficiency, accuracy, and completeness of State processes and systems
used to collect, analyze and report large truck and bus crash and
inspection data.
    The FMCSA will reimburse each recipient 80 percent of eligible
costs incurred in carrying out approved projects; the recipient must
provide 20 percent in matching funds for these activities. Eligible
applicants are State agencies, including the territories of Puerto
Rico, Guam, American Samoa, the Northern Marianas, and the U.S. Virgin
Islands, and the District of Columbia. Applicants must certify that
they have (1) conducted a comprehensive audit of its CMV safety data
system within the preceding two years; (2) developed a plan that
identifies and prioritizes its CMV safety data needs and goals; and (3)
identified performance-based measures to determine progress toward
those goals.

PRISM Grants

    Sections 4101(c)(3) and 4109 of SAFETEA-LU, as amended by secs.
32602 and 32603(c) of MAP-21, authorize the PRISM grant program. The
goal of the PRISM grant is to assist States in identifying motor
carriers responsible for the safety of CMV operations and to monitor
the safety fitness of those carriers by linking the vehicle
registration process to safety performance monitoring and enforcement.
    The FMCSA will reimburse each recipient 100 percent of eligible
costs incurred in carrying out approved projects. Eligible applicants
include States, U.S. Territories and Commonwealths, and the District of
Columbia.

CMV Operator Safety Training Grants

    Section 4134 of SAFETEA-LU, as amended by sec. 32603(g) of MAP-21,
authorizes the CMV Operator Safety Training grant program. The goal of
the CMV Operator Safety Training grant program is to train potential
drivers in the safe operation of CMVs.
    The FMCSA will reimburse each recipient 80 percent of eligible
costs incurred in carrying out approved projects; the recipient must
provide 20 percent in matching funds for these activities. Eligible
applicants include State and local governments and accredited, post-
secondary educational institutions (public or private) such as
colleges, universities, vocational-technical schools and truck driver
training schools. FMCSA will give priority to those schools that
develop a program to assist current or former members of the U.S. Armed
Forces (including Guard members and Reservists) and their spouses to
receive training to transition to the CMV operation industry and
provide job placement assistance after graduation. Secondary to the
first National priority, FMCSA may also consider those

applicants that demonstrate in the application a capacity to recruit
and train individuals and provide job placement assistance after
graduation to persons in documented economically-distressed regions of
the U.S.

Evaluation Factors

    Below are evaluation factors that FMCSA will use to review
applications for all FMCSA discretionary grants. Additional factors may
be included in each NOFA. These factors are:
    (1) Prior Performance (e.g., completion of identified programs and
goals per the project plan submitted under previous grants awarded to
the applicant), if applicable;
    (2) Effective Use of Prior Grants (e.g., timely use of available
funds in previous awards), if applicable;
    (3) Safety and Cost Effectiveness (e.g., expected impact on safety
relative to the investment of grant funds; where appropriate, cost per
unit was calculated and compared with national averages to determine
effectiveness; in other areas, proposed costs are compared with
historical information to confirm reasonableness);
    (4) Applicability to Announced Priorities; grant applications that
specifically address these issues are given priority consideration;
    (5) Ability of the applicant to support the strategies and
activities in the proposal for the entire project period of
performance;
    (6) Use of innovative approaches in executing a project plan to
address identified safety issues;
    (7) Feasibility of overall program coordination and implementation
based upon the project plan; and
    (8) Other objective and performance-based criteria that FMCSA deems
appropriate, such as consistency with national priorities, overall
program balance, and geographic diversity.

Application Due Dates

    For the following grant programs, FMCSA will consider funding
complete applications or plans submitted by the following dates (any
changes to these dates will be indicated in the Grants.Gov NOFA):
    MCSAP Basic and Incentive Grants--August 1, 2013.
    Border Enforcement Grants--August 12, 2013.
    New Entrant Safety Audit Grants--August 26, 2013.
    MCSAP High Priority Grants--September 9, 2013.
    CDLPI Grants--January 13, 2014.
    CVISN Grants--January 13, 2014.
    SaDIP Grants--January 21, 2014.
    PRISM Grants--January 27, 2014.
    CMV Operator Safety Training Grants--February 3, 2014.
    Applications submitted after due dates may be considered on a case-
by-case basis and are subject to availability of funds.

    Issued under the authority delegated in 49 CFR 1.87 on June 14,
2013.
William A. Quade,
Associate Administrator for Enforcement.
[FR Doc. 2013-14896 Filed 6-20-13; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 88, Number 47 (Friday, March 10, 2023)]
[Notices]
[Pages 15116-15118]
[FR Doc No: 2023-04957]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

Notice of Updated Civil Penalty Schedules and Guidelines

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

ACTION: Notice of availability.

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SUMMARY: FRA is issuing this notice to advise all interested
stakeholders that it has issued, and made available on its website,
updated civil penalty schedules and guidelines (Schedules) to account
for inflation. This notice explains FRA's increase to its guideline
rail safety civil penalty amounts. This notice also announces FRA's
intent to adjust the civil penalty amounts line-by-line on an annual
basis for inflation, after this adjustment.

FOR FURTHER INFORMATION CONTACT: Veronica Chittim, Senior Attorney,
Office of the Chief Counsel, telephone:<PHONE_NUMBER>, email:
[email protected].

SUPPLEMENTARY INFORMATION:

Background

    FRA is authorized as the delegate of the Secretary of
Transportation to enforce the Federal railroad safety and hazardous
materials transportation statutes, regulations, and orders, including
the civil penalty provisions codified primarily at 49 U.S.C. chs. 51
and 213.\1\ FRA currently has safety regulations in 36 parts of the
Code of Federal Regulations (CFR) that contain provisions establishing
the agency's authority to impose civil penalties if a person \2\
violates any requirement in the pertinent portion of a statute,
regulation, or order. Out of those 36 CFR parts, 32 contain civil
penalty Schedules constituting a statement of agency policy. These
Schedules were historically issued as an appendix to the relevant part
of the CFR. In 2019, FRA relocated the existing Schedules from the CFR
to FRA's website (https://railroads.dot.gov/legislation-regulations/civil-penalties-schedules-guidelines).\3\ Since 2019, FRA has
incorporated updates to the Schedules to account for regulatory
changes, to reflect updated minimum and maximum statutory civil
monetary penalty (CMP) amounts, and to add Schedules for FRA
regulations (i.e., 49 CFR parts 271 and 299).
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    \1\ 49 U.S.C. 103 and 49 CFR 1.89; 49 U.S.C. chs. 51, 201-213.
    \2\ 49 CFR 209.3.
    \3\ 84 FR 23730 (May 23, 2019).
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    FRA last published comprehensive, line-by-line revisions to the
Schedules of its safety regulations in 1988.\4\ The revisions reflected
the higher maximum penalty amounts the Rail Safety Improvement Act of
1988 (RSIA of 1988) established.\5\ With the exception of the penalties
relating to the hours of service laws (49 U.S.C. ch. 211),\6\ RSIA

of 1988 raised the maximum penalty for an ordinary violation from
$2,500 to $10,000 (ordinary maximum) and to $20,000 for a grossly
negligent violation or pattern of repeated violations that has caused
an imminent hazard or death or injury to individuals, or has caused
death or injury (aggravated maximum). Therefore, FRA published
amendments to the Schedules to ``give effect to the full range of civil
penalties . . . permitted to be assessed for violation of specific
regulations.'' \7\ In these amendments, FRA revised not only the
ordinary and aggravated maximum CMP amounts per violation, but also the
individual, line-item penalties for specific sections or subsections of
the regulations.
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    \4\ 53 FR 52918 (Dec. 29, 1988).
    \5\ Pub. L. 100-342.
    \6\ The Rail Safety Enforcement and Review Act (RSERA) (Pub. L.
102-365, Sept. 3, 1992), increased the maximum penalty for a
violation of the hours of service laws, from $1,000 to $10,000, and
in some cases to $20,000, making these penalty amounts consistent
with those of FRA's other regulatory provisions. RSERA also
increased the minimum penalty from $250 to $500 for all of FRA's
regulatory provisions.
    \7\ 53 FR 52918.
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    Since the publication of the Schedules in 1988, FRA has
periodically adjusted its minimum CMP and its ordinary and aggravated
maximum CMPs to conform to the mandates of the Federal Civil Penalties
Inflation Adjustment Act of 1990 (Inflation Act).\8\ The Inflation Act
required each agency to: (1) adjust by regulation each maximum CMP, or
range of minimum and maximum CMPs, within that agency's jurisdiction;
and (2) adjust those penalty amounts once every four years thereafter,
to reflect inflation.\9\ FRA periodically reviewed its minimum CMP and
ordinary and aggravated maximum CMPs as the Inflation Act required and
adjusted them as appropriate.\10\
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    \8\ Public Law 101-410, 104 Stat. 890, 28 U.S.C. 2461 note, as
amended by Sec. 31001(s)(1) of the Debt Collection Improvement Act
of 1996, Public Law 104-134, 110 Stat. 1321-373, Apr. 26, 1996.
    \9\ Id.
    \10\ See, e.g., 63 FR 11618 (Mar. 10, 1998); 69 FR 30591 (May
28, 2004); 72 FR 51194 (Sept. 6, 2007).
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    The Rail Safety Improvement Act of 2008 (RSIA) increased the
ordinary and aggravated maximum CMPs to $25,000 and $100,000,
respectively.\11\ In 2008, FRA adjusted its minimum CMP from $550 to
$650 under the Inflation Act, and also adopted $25,000 as the ordinary
maximum and $100,000 as the aggravated maximum CMPs required by the
RSIA.\12\ Subsequently, in 2012, FRA adjusted the aggravated maximum
CMP for inflation to $105,000, but kept the minimum and ordinary
maximum CMPs unchanged.\13\
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    \11\ Public Law 110-432, Div. A, Sec. 302.
    \12\ Id.; 74 FR 15387 (Apr. 6, 2009).
    \13\ 77 FR 24415 (Apr. 24, 2012).
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    Under the Federal Civil Penalties Inflation Adjustment Act
Improvements Act of 2015 (2015 Inflation Act), agencies were required
to make a catch-up adjustment for the minimum, ordinary maximum, and
aggravated maximum CMPs, followed by annual inflation adjustments.\14\
FRA has adjusted the statutory minimum, ordinary maximum, and
aggravated maximum CMPs pursuant to the 2015 Inflation Act, with the
most recent adjustment occurring on January 6, 2023.\15\
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    \14\ Public Law 114-74, Sec. 701 (Nov. 2, 2015).
    \15\ See 49 CFR part 209, appendix A. Effective January 6, 2023,
the minimum CMP was raised from $976 to $1,052, the ordinary maximum
CMP was raised from $31,928 to $34,401, and the aggravated maximum
CMP was raised from $127,712 to $137,603. See 88 FR 1114.
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    FRA's practice has been to issue Schedules assigning to each
section or subsection of the regulations specific dollar amounts for
initial penalty assessments. These Schedules (and all line-item penalty
amounts found within them) are statements of agency policy that specify
the penalty that FRA will ordinarily assess for the violation of a
particular section or subsection of a safety regulation, and are
published to inform members of the regulated community of the penalty
FRA will likely assess for a given violation within the range of the
statutory minimum to the aggravated maximum CMP. The Schedules are not
regulations nor are they subject to notice-and-comment requirements.
The Schedules provide guidance on FRA's policy in predictable
situations, but they do not prevent FRA from using the full range of
penalty authority when circumstances warrant. Thus, regardless of the
amounts shown in the Schedules, FRA continues to reserve the right to
assess, within the range established by the rail safety statutes (49
U.S.C. ch. 213) or by regulation under the 2015 Inflation Act, an
amount other than that listed in the Schedules based on the
circumstances of the alleged violation.
    The Schedules included in these statements of agency policy
continue to provide guideline penalty amounts for two categories of
violations: ordinary (non-willful) and willful. Each Schedule lists the
CFR section or subsection in the left-hand column, sometimes with
additional designations to distinguish different types of violations
(penalty codes) of the section or subsection, to facilitate the
assessment of civil penalties.\16\ The corresponding guideline penalty
amount for an ordinary violation and then the guideline penalty amount
for a willful violation are listed. The ordinary penalties apply to
railroads or other respondents, except individuals, while the
``willful'' column applies to willful violations committed by railroads
or other respondents, including individuals.
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    \16\ The only exception is 49 CFR part 231; the left-hand column
of the Schedule lists the FRA defect codes for that part, and not
the corresponding CFR sections. This is because the defect codes are
organized by the type of safety appliance, which makes them easier
to use than the section numbers of part 231, which are organized
primarily by car or locomotive type. Nevertheless, if necessary,
every defect code can be traced to a specific regulatory provision
in part 231 or statutory provision in 49 U.S.C. ch. 203, or both.
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Updated Civil Penalty Schedules

    FRA is updating, line-by-line, FRA's civil penalty Schedules to
account for inflation. Although the 2015 Inflation Act did not require
FRA to adjust individual, line-item penalty amounts, Congress'
recognition in that Act of the negative impact that inflation has on
the deterrent effect of FRA's civil penalties, and the fact FRA has
never adjusted each of its civil penalties to specifically account for
inflation, prompted FRA to update these statements of agency policy.
FRA believes the new inflation-adjusted penalty amounts in these
statements of agency policy will preserve the deterrent effects of the
CMPs, supporting FRA's mission to make the United States' rail system
safer.
    Many of FRA's existing CMP guideline amounts are below the 2023
statutory minimum CMP amount of $1,052.\17\ To address this issue both
specifically for the existing $1,000 guideline CMPs and to combat the
erosion of the deterrent effect of FRA's civil penalties in a
consistent manner, FRA is updating all rail safety CMP guideline
amounts.
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    \17\ See, e.g., a guideline base CMP for a non-willful violation
of 49 CFR 213.241, Inspection records, $1,000.
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    Effective for violations occurring on or after March 8, 2023, FRA
has increased all rail safety penalties by multiplying the base, pre-
adjusted penalty, by two. For example, a base penalty of $2,500 will
increase to $5,000. Beginning in 2024, FRA intends to annually adjust
all of its Schedules by a fixed inflation rate factor (using the
Consumer Price Index), similar to the calculation used to adjust the
statutory minimum and maximum CMPs. FRA will continue to post such
inflation updates to its Schedules on FRA's website (https://railroads.dot.gov/legislation-regulations/civil-penalties-schedules-guidelines).

Conclusion

    To promote railroad safety by enhancing and maintaining the
deterrent effect of the civil penalty program, FRA is doubling its
guideline

penalties to account for inflation. Beginning in 2024, FRA expects to
annually adjust its civil penalty Schedules indexed to the rate of
inflation. All updates to these statements of agency policy can be
found on FRA's website (https://railroads.dot.gov/legislation-regulations/civil-penalties-schedules-guidelines).

    Issued in Washington, DC.
Allison Ishihara Fultz,
Chief Counsel.
[FR Doc. 2023-04957 Filed 3-9-23; 8:45 am]
BILLING CODE 4910-06-P


[Federal Register Volume 88, Number 119 (Thursday, June 22, 2023)]
[Notices]
[Page 40802]
[FR Doc No: 2023-13260]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2107-054]

Pacific Gas and Electric Company; Notice of Application Accepted
for Filing and Soliciting Comments, Motions To Intervene, and Protests

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:
    a. Application Type: Application for Temporary Variance of Flow and
Flow-Related Environmental Monitoring Requirements.
    b. Project No: 2107-054.
    c. Date Filed: April 7, 2023.
    d. Applicant: Pacific Gas and Electric Company (licensee).
    e. Name of Project: Poe Hydroelectric Project.
    f. Location: The project is located on the North Fork Feather
River, upstream of Lake Oroville, near the Town of Pulga, in Butte
County, California.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791a-825r.
    h. Applicant Contact: Mr. Sky Ramirez-Doble, License Coordinator,
Pacific Gas and Electric Company, Mail Code: N11D, P.O. Box 770000, San
Francisco, CA 94177, Phone:<PHONE_NUMBER>.
    i. FERC Contact: Katherine Schmidt,<PHONE_NUMBER>,
[email protected].
    j. Deadline for filing comments, motions to intervene, and
protests: July 17, 2023.
    The Commission strongly encourages electronic filing. Please file
comments, motions to intervene, and protests using the Commission's
eFiling system at https://www.ferc.gov/docs-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 at [email protected],<PHONE_NUMBER> (toll
free), or<PHONE_NUMBER> (TTY). In lieu of electronic filing, you may
submit a paper copy. Submissions sent via the U.S. Postal Service must
be addressed to: Kimberly D. Bose, Secretary, Federal Energy Regulatory
Commission, 888 First Street NE, Room 1A, Washington, DC 20426.
Submissions sent via any other carrier must be addressed to: Kimberly
D. Bose, Secretary, Federal Energy Regulatory Commission, 12225 Wilkins
Avenue, Rockville, Maryland 20852. The first page of any filing should
include the docket number P-2107-054. Comments emailed to Commission
staff are not considered part of the Commission record.
    The Commission's Rules of Practice and Procedure require all
intervenors filing documents with the Commission to serve a copy of
that document on each person whose name appears on the official service
list for the project. Further, if an intervenor files comments or
documents with the Commission relating to the merits of an issue that
may affect the responsibilities of a particular resource agency, they
must also serve a copy of the document on that resource agency.
    k. Description of Request: The licensee requests a temporary
reduction in minimum instream flow below Poe Dam down to 100 cubic feet
per second, as measured at compliance point NF-23 (United States
Geological Survey gage 11404500), from date variance is approved until
November 1, 2023, to facilitate recoating and replacing the seals of
the Poe Bypass radial gate. While work on the radial gate is being
performed, minimum instream flows will be released through an existing
36-inch pipe during the variance period, at its maximum release
capacity. To offset recreational impacts to whitewater opportunities,
the licensee proposes a make-up schedule of November 18 & 19, and
November 25 & 26, 2023, of similar boating flows, if the variance is
approved. In addition, the licensee also requests to postpone 2023
monitoring activities performed under the Poe Bypass Reach Fish and
Benthic Macroinvertebrate Monitoring Plan and the Poe Tributary Access
Monitoring Plan for similar dates in 2024.
    l. Locations of the Application: This filing may be viewed on the
Commission's website at 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. You may also register
online at http://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, call 1-866-208-3676 or email
[email protected], for TTY, call<PHONE_NUMBER>. Agencies may
obtain copies of the application directly from the applicant.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Protests, or Motions to Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214, respectively. In determining the appropriate action to take, the
Commission will consider all protests or other comments filed, but only
those who file a motion to intervene in accordance with the
Commission's Rules may become a party to the proceeding. Any comments,
protests, or motions to intervene must be received on or before the
specified comment date for the particular application.
    o. Filing and Service of Documents: Any filing must (1) bear in all
capital letters the title ``COMMENTS'', ``PROTEST'', or ``MOTION TO
INTERVENE'' as applicable; (2) set forth in the heading the name of the
applicant and the project number of the application to which the filing
responds; (3) furnish the name, address, and telephone number of the
person commenting, protesting or intervening; and (4) otherwise comply
with the requirements of 18 CFR 385.2001 through 385.2005. All
comments, motions to intervene, or protests must set forth their
evidentiary basis. Any filing made by an intervenor must be accompanied
by proof of service on all persons listed in the service list prepared
by the Commission in this proceeding, in accordance with 18 CFR
385.2010.
    p. The Commission's Office of Public Participation (OPP) supports
meaningful public engagement and participation in Commission
proceedings. OPP can help members of the public, including landowners,
environmental justice communities, Tribal members and others, access
publicly available information and navigate Commission processes. For
public inquiries and assistance with making filings such as
interventions, comments, or requests for rehearing, the public is
encouraged to contact OPP at<PHONE_NUMBER> or [email protected].

    Dated: June 15, 2023.
Kimberly D. Bose,
Secretary.
[FR Doc. 2023-13260 Filed 6-21-23; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: March 1, 2007 (Volume 72, Number 40)]
[Notices]
[Page 9328-9330]
[DOCID:fr01mr07-59]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OW-2007-0142; FRL-8282-6]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Information Collection Request for Cooling Water
Intake Structure Phase II Existing Facilities, EPA ICR No. 2060.03, OMB
Control No. 2040-0257

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: In compliance with the Paperwork Reduction Act (PRA) (44
U.S.C. 3501 et seq.), this document announces that EPA is planning to
submit a request to renew an existing approved Information Collection
Request (ICR) to the Office of Management and Budget (OMB). Before
submitting the ICR to OMB for review and approval, EPA is soliciting
comments on specific aspects of the proposed information collection as
described below.

DATES: Comments must be submitted on or before April 30, 2007.

ADDRESSES: Submit your comments, referencing docket ID number EPA-HQ-
OW-2007-0142, by one of the following methods:
      http://www.regulations.gov: Follow the online

instructions for submitting comments.
     E-mail<EMAIL_ADDRESS>(Identify Docket ID number EPA-
HQ-OW-2007-0142, in the subject line)
     Mail: Water Docket, Environmental Protection Agency,
Mailcode: 4203M, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
Please include a total of three copies.
     Hand Delivery: EPA Docket Center, EPA West, Room B102,
1301 Constitution Avenue, NW., Washington, DC. Such deliveries are only
accepted during the Docket's normal hours of operation, and special
arrangements should be made for deliveries of boxed information.
    Instructions: Direct your comments identified by the Docket ID
number EPA-HQ-OW-2007-0142. EPA's policy is that all comments received
will be included in the public docket without change and may be made
available online at http://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 http://www.regulations.gov or e-mail. The http://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 e-mail comment directly to EPA without going through
http://www.regulations.gov, your e-mail 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. For additional information about EPA's public docket, visit
the EPA Docket Center homepage at http:// www.epa.gov/epahome/

dockets.htm.

FOR FURTHER INFORMATION CONTACT: Amelia Letnes, State and Regional
Branch, Water Permits Division, OWM Mail Code: 4203M, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460;
telephone number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION:

How Can I Access the Docket and/or Submit Comments?

    EPA has established a public docket for the ICR identified in this
document (ID number EPA-HQ-OW-2007-0142), which is available for online
viewing at http://www.regulations.gov, or in person viewing at the

Water Docket in the EPA Docket Center (EPA/DC), EPA West, Room B102,
1301 Constitution Ave., NW., Washington, DC. The EPA/DC Public Reading
Room is open from 8 a.m. to 4:30 p.m., Monday through Friday, excluding
legal holidays. The telephone number for the Reading Room is 202-566-
1744, and the telephone number for the Water Docket is<PHONE_NUMBER>.
    Use http://www.regulations.gov to obtain a copy of the draft

collection of information, submit or view public comments, access the
index listing of the contents of the docket, and to access those
documents in the public docket that are available electronically. Once
in the system, select ``search,'' then key in the docket ID number
identified in this document.

What Information Is EPA Particularly Interested In?

    Pursuant to section 3506(c)(2)(A) of the PRA, EPA specifically
solicits comments and information to enable it to:
    (i) Evaluate whether the proposed collection of information is
necessary for the proper performance of the functions of the Agency,
including whether the information will have practical utility;
    (ii) Evaluate the accuracy of the Agency's estimate of the burden
of the proposed collection of information, including the validity of
the methodology and assumptions used;
    (iii) Enhance the quality, utility, and clarity of the information
to be collected; and
    (iv) Minimize the burden of the collection of information on those
who are to respond, including through the use of appropriate automated
electronic, mechanical, or other technological collection techniques or
other forms of information technology, e.g., permitting electronic
submission of responses. In particular, EPA is requesting comments from
very small businesses (those that employ less than 25) on examples of
specific additional efforts that EPA could make to reduce the paperwork
burden for very small businesses affected by this collection.

What Should I Consider When I Prepare My Comments for EPA?

    You may find the following suggestions helpful for preparing your
comments:
    1. Explain your views as clearly as possible and provide specific
examples.
    2. Describe any assumptions that you used.
    3. Provide copies of technical information/data you used that
support your views.
    4. If you estimate potential burden or costs, explain how you
arrived at the estimate that you provide.
    5. Offer alternative ways to improve the collection activity.
    6. Make sure to submit your comments by the deadline identified
under DATES.
    7. To ensure proper receipt by EPA, be sure to identify the docket
ID number assigned to this action in the subject line on the first page
of your response. You may also provide the name, date, and Federal
Register citation.

What Information Collection Activity or ICR Does This Apply to?

    Affected entities: Entities potentially affected by this action
include existing electric power generating facilities meeting the
applicability criteria of the 316(b) Phase II Existing Facility rule at
40 CFR 125.91.
    Title: Information Collection Request for Cooling Water Intake
Structure Phase II Existing Facilities.
    ICR numbers: EPA ICR No. 2060.03, OMB Control No. 2040-0257.
    ICR status: An Agency may not conduct or sponsor, and a person is
not required to respond to, a collection of information, unless it
displays a currently valid OMB control number. The OMB control numbers
for EPA's regulations in title 40 of the CFR, after appearing in the
Federal Register when approved, are listed in 40 CFR Part 9, and
displayed either by publication in the Federal Register or by other
appropriate means, such as on the related collection instrument or
form, if applicable. The display of OMB control numbers in certain EPA
regulations is consolidated in 40 CFR part 9.
    Abstract: The section 316(b) Phase II Existing Facility rule
requires the collection of information from existing point source
facilities that generate and transmit electric power (as a primary
activity) or generate electric power but sell it to another entity for
transmission, use a cooling water intake structure (CWIS) that uses at
least 25 percent of the water it withdraws from waters of the U.S. for
cooling purposes, and have a design intake flow of 50 million gallons
per day (MGD) or more. Section 316(b) of the Clean Water Act (CWA)
requires that any standard established under section 301 or 306 of the
CWA and applicable to a point source must require that the location,
design, construction and capacity of CWISs at that facility reflect the
best technology available (BTA) for minimizing adverse environmental
impact. Such impact occurs as a result of impingement (where fish and
other aquatic life are trapped on technologies at the entrance to CWIS)
and entrainment (where aquatic organisms, eggs, and larvae are taken
into the cooling system, passed through the heat exchanger, and then
pumped back out with the discharge from the facility). The 316(b) Phase
II rule establishes requirements applicable to the location, design,
construction, and capacity of CWISs at Phase II existing facilities.
These requirements establish the BTA for minimizing adverse
environmental impact associated with the use of CWISs.
    On January 25, 2007, the United States Court of Appeals for the
Second Circuit remanded to EPA certain provisions in the 2004 Final
Regulations to Establish Requirements for Cooling Water Intake
Structures at Phase II Existing Facilities (See Riverkeeper, Inc.

v. U.S. EPA, No. 04-6692-ag(L) [2d Cir. Jan. 25, 2007]). EPA is
continuing to review the decision to determine its impact on the Phase
II Rule. Therefore, this ICR does not address the results of the court
decision.
    Burden Statement: The annual average reporting and record keeping
burden for the collection of information by facilities responding to
the Section 316(b) Phase II Existing Facility rule is estimated to be
2,983 hours per facility respondent (i.e., an annual average of
1,157,216 hours of burden divided among an anticipated annual average
of 388 facilities). The state Director reporting and record keeping
burden for the review, oversight, and administration of the rule is
estimated to average 2,034 hours per state respondent (i.e., an annual
average of 83,383 hours of burden divided among an anticipated 41
States on average per year). Burden means the total time, effort, or
financial resources expended by persons to generate, maintain, or
disclose or provide information to or for a Federal agency. This
includes the time needed to review instructions; develop, acquire,
install, and use technology and systems for the purposes of collecting,
validating, and verifying information, processing and maintaining
information, and disclosing and providing information; adjust the
existing ways to comply with any previously applicable instructions and
requirements; train personnel to be able to respond to a collection of
information; search data sources; complete and review the collection of
information; and transmit or otherwise disclose information.
    The ICR provides a detailed explanation of the Agency's estimate,
which is only briefly summarized here:
    Estimated total number of potential respondents: 549 (508
facilities and 41 states).
    Frequency of response: Bi-annually, every five years.
    Estimated total average number of responses for each respondent:
24.
    Estimated total annual burden hours: 1,240,599 hours.
    Estimated total annual costs: $80,556,134. This includes an
estimated burden cost of $65,592,289 and an estimated cost of
$14,963,845 for capital investment or maintenance and operational
costs.
    Changes in the Estimates: The change in burden results mainly from
the shift from the approval period to the renewal period of the 316(b)
Phase II Existing Facilities rule. This ICR covers the last 2 years of
the permit approval period (i.e., years 4 and 5 after implementation)
and the first year of the renewal period (i.e., year 6 after
implementation). Activities for renewing an NPDES permit already issued
under the 316(b) Phase II Existing Facilities rule are less burdensome
than those for issuing a permit for the first time. Additionally, for
the approval period ICR (EPA ICR No. 2060.02), EPA assumed that all
facilities complying with the rule would be in NPDES-authorized States.
EPA has moved away from this assumption, and, for this ICR, all
calculations are based on the estimated number and type of facilities
in authorized and non-authorized States.

    Dated: February 23, 2007.
James A. Hanlon,
Director, Office of Wastewater Management.
[FR Doc. E7-3589 Filed 2-28-07; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 84, Number 206 (Thursday, October 24, 2019)]
[Notices]
[Pages 57028-57029]
[FR Doc No: 2019-23197]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-4467]

Breast Implants--Certain Labeling Recommendations To Improve
Patient Communication; Draft Guidance for Industry and Food and Drug
Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of the draft guidance entitled ``Breast Implants--
Certain Labeling Recommendations to Improve Patient Communication.''
This draft guidance contains recommendations concerning the content and
format for certain labeling information for saline and silicone gel-
filled breast implants. FDA is seeking comments on all aspects of the
draft guidance, including the respective benefits and risks of smooth
and textured breast implants and applicability of the recommendations
to both types. This draft guidance is not final nor is it in effect at
this time.

DATES: Submit either electronic or written comments on the draft
guidance by December 23, 2019 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-2019-D-4467 for ``Breast Implants--Certain Labeling Recommendations
to Improve Patient Communication.'' 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.
     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.gpo.gov/fdsys/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.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the draft guidance document entitled
``Breast Implants--Certain Labeling Recommendations to Improve Patient
Communication'' to the Office of Policy, Guidance and Policy
Development, Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist
that office in processing your request.

FOR FURTHER INFORMATION CONTACT: Cynthia Chang, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4646, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Over the past few years, FDA has received new information
pertaining to risks associated with breast implants, including breast
implant-associated anaplastic large cell lymphoma and systemic symptoms
commonly referred to as breast implant illness that some patients
attribute to their implants. FDA has taken several steps to better
understand and address risks associated with breast implants, including
convening the General and Plastic Surgery Devices Panel of the Medical
Devices Advisory Committee on March

25-26, 2019, to discuss the long-term benefits and risks of breast
implants indicated for breast augmentation and reconstruction. FDA
learned from presentations at the March 2019 panel meeting, and through
comments submitted to the associated public docket, that some patients
may not be receiving or understanding important information regarding
the benefits and risks of breast implants in a format that allows them
to make a well-informed decision about whether or not to have a breast
implantation.
    For these reasons, FDA is now providing recommendations concerning
the content and format of certain labeling information for these
devices. Specifically, FDA is recommending that manufacturers
incorporate a boxed warning and a patient decision checklist into the
labeling for these devices to better ensure certain information is
received and understood by patients. This draft guidance also
recommends updated and additional labeling information, including
updates to the silicone gel-filled breast implant rupture screening
recommendations, inclusion of an easy-to-find description of materials,
and provision of patient device cards that were recommended at the
March 2019 panel meeting.
    This draft guidance is not intended to include a complete listing
of all labeling components for breast implants. When finalized, the
recommendations in this draft guidance will supplement or in some cases
replace recommendations in FDA's guidance entitled ``Saline, Silicone
Gel, and Alternative Breast Implants'' (November 2006) (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/saline-silicone-gel-and-alternative-breast-implants).
    Based on the information presented at the March 2019 panel meeting,
FDA continues to gather available information regarding the benefits
and risks associated with different types of breast implants, and
consider appropriate labeling and regulatory requirements for them. FDA
will continue to analyze all available information regarding the risks
associated with breast implants and take additional actions as
determined necessary or appropriate. FDA invites comments on the
benefits and risks of smooth and textured breast implants,
respectively, as well as the labeling recommendations for these
implants.

II. Significance of Guidance

    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 ``Breast
Implants--Certain Labeling Recommendations to Improve Patient
Communication.'' 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.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do
so by downloading an electronic copy from the internet. A search
capability for all Center for Devices and Radiological Health guidance
documents is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. This
guidance document is also available at https://www.regulations.gov.
Persons unable to download an electronic copy of ``Breast Implants--
Certain Labeling Recommendations to Improve Patient Communication'' may
send an email request to<EMAIL_ADDRESS>to receive an
electronic copy of the document. Please use the document number 19021
to identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information. These collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501-3521). The collections of information in
the following FDA regulations have been approved by OMB as listed in
the following table:

------------------------------------------------------------------------
 21 CFR Part; guidance; or FDA                             OMB  control
              form                        Topic                 No.
------------------------------------------------------------------------
814, subparts A through E......  Premarket approval.....       0910-0231
812............................  Investigational Device        0910-0078
                                  Exemption.
801............................  Medical Device Labeling       0910-0485
                                  Regulations.
50, 56.........................  Protection of Human           0910-0755
                                  Subjects: Informed
                                  Consent; Institutional
                                  Review Boards.
830............................  Unique Device                 0910-0720
                                  Identification System.
820............................  Current Good                  0910-0073
                                  Manufacturing Practice
                                  (CGMP); Quality System
                                  Regulation.
------------------------------------------------------------------------

    Dated: October 18, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-23197 Filed 10-23-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 83, Number 131 (Monday, July 9, 2018)]
[Notices]
[Page 31750]
[FR Doc No: 2018-14566]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2684-010]

Flambeau Hydro, LLC; Notice of Availability of Environmental
Assessment

    In accordance with the National Environmental Policy Act of 1969
and the Federal Energy Regulatory Commission's (Commission)
regulations, 18 CFR part 380, the Office of Energy Projects has
reviewed the application for a subsequent license for the Arpin Dam
Project, located on the Chippewa River in Sawyer County, Wisconsin, and
has prepared an Environmental Assessment (EA) for the project.
    The EA contains staff's analysis of the potential environmental
impacts of the project and concludes that licensing the project, with
appropriate environmental protective measures, would not constitute a
major federal action that would significantly affect the quality of the
human environment.
    A copy of the EA is available for review at the Commission in the
Public Reference Room or may be viewed on the Commission's website at
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. For assistance, contact FERC Online Support at
[email protected],<PHONE_NUMBER> (toll free), or (202) 502-
8659 (TTY).
    You may also register online at http://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.
    The Commission strongly encourages electronic filing. Please file
comments using the Commission's eFiling system at http://www.ferc.gov/docs-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. In lieu of electronic
filing, please send a paper copy to: Secretary, Federal Energy
Regulatory Commission, 888 First Street NE, Washington, DC 20426. The
first page of any filing should include docket number P-2684-010.
    For further information, contact Amy Chang at<PHONE_NUMBER>.

    Dated: June 28, 2018.
Kimberly D. Bose,
Secretary.
[FR Doc. 2018-14566 Filed 7-6-18; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 3 (Monday, January 6, 2014)]
[Rules and Regulations]
[Pages 580-582]
[FR Doc No: 2013-31566]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R07-OAR-2012-0767; FRL-9905-03-Region 7]

Approval and Promulgation of Air Quality Implementation Plans;
Missouri; Reasonably Available Control Technology (RACT) for the 8-Hour
Ozone National Ambient Air Quality Standard (NAAQS)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is taking final
action to approve a State Implementation Plan (SIP) revision submitted
by the State of Missouri to EPA in a letter dated May 4, 2012. The
purpose of the SIP revision is to amend Missouri's regulation for the
control of Volatile Organic Compounds (VOC) and meet the requirement to
adopt reasonably available control technology (RACT) for sources
covered by EPA's Control Technique Guidelines (CTG) for Industrial
Cleaning Solvents. We are taking final action to approve this revision
because it satisfies the applicable requirements of the Clean Air Act
(CAA) with respect to RACT for the Missouri portion of the St. Louis
Metropolitan 1997 8-hour ozone nonattainment area.

DATES: This final rule is effective February 5, 2014.

ADDRESSES: EPA has established a docket for this action under Docket
Identification No. EPA-R07-OAR-2012-0767. All documents in the docket
are listed on the http://www.regulations.gov index. Although listed in
the index, some information is not publicly available, i.e.,
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Certain other material, such as
copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available either electronically in http://www.regulations.gov or in hard copy at the Air Planning and Development
Branch, Air and Waste Management Division, U.S. Environmental
Protection Agency Region 7, 11201 Renner Boulevard, Lenexa, Kansas
66219. EPA requests that if at all possible, you contact the person
listed in the FOR FURTHER INFORMATION CONTACT section to schedule your
inspection. The Regional Office's official hours of business are Monday
through Friday, 8:30 a.m. to 4:30 p.m., excluding Federal holidays. The
interested persons wanting to examine these documents should make an
appointment with the office at least 24 hours in advance.

FOR FURTHER INFORMATION CONTACT: Ms. Lachala Kemp, Air Planning and
Development Branch, U.S. Environmental Protection Agency Region 7,
11201 Renner Boulevard, Lenexa, Kansas 66219; telephone number (913)
551-7214; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us,'' or
``our'' refer to EPA. This section provides additional information by
addressing the following:

I. What action is EPA taking in this final rule?
II. What is the background for the approvals by EPA in this final
rule?
III. EPA's Final Action

I. What action is EPA taking in this final rule?

    EPA is taking final action to approve a SIP revision submitted by
the State of Missouri to EPA on May 4, 2012. The purpose of this
revision is to control the emissions of VOCs, consistent with Control
Techniques Guidelines (CTGs) issued by EPA, and to satisfy the RACT
requirements of the CAA for the Missouri portion of the St. Louis
metropolitan 1997 8-hour ozone nonattainment area. Specifically, the
revision incorporates an amendment to

an existing SIP-approved Missouri regulation 10 Code of State
Regulations 10-5.455 to control emissions from Industrial Solvent
Cleaning Operations in the St. Louis metropolitan area. The revision
includes lowering the allowable emissions threshold for VOCs released
per day from the use, storage and disposal of industrial cleaning
solvents, and adds requirements for facilities that exceed the
applicability threshold. EPA is taking final action to approve this
revision because the adoption by Missouri of this regulation represents
RACT control levels for CTGs issued by EPA after 2006. In addition, EPA
is taking final action to approve this revision because it meets the
requirements of the conditional approval EPA issued on January 10,
2012. See 77 FR 3144 (January 23, 2012).

II. What is the background for the approvals by EPA in this final rule?

    This section briefly summarizes the background for today's final
action. More detailed discussion of the statutory and regulatory
background can be found in the preamble to the proposal for this
rulemaking. See 78 FR at 45112-45114 (July 26, 2013). No comments were
received on the proposed rulemaking.
    The St. Louis metropolitan area--which includes the counties of
Franklin, Jefferson, St. Charles and St. Louis, and the City of St.
Louis in Missouri (as well as four counties in Illinois), is currently
designated as a moderate nonattainment area under the 1997 8-hour ozone
National Ambient Air Quality Standard (NAAQS).\1\ For areas in moderate
nonattainment with the ozone NAAQS, section 182(b)(2) of the CAA
requires states to submit SIP revisions to EPA that require sources of
VOCs in the nonattainment area that are subject to a CTG issued by EPA,
and all other major stationary sources,\2\ to implement RACT.
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    \1\ The St. Louis metropolitan area was also recently designated
as a ``marginal'' nonattainment area for the 2008 ozone NAAQS.
    \2\ For a moderate nonattainment area, a major stationary source
is one which emits, or has the potential to emit, one hundred tons
per year or more of VOCs. See CAA section 302(j).
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    EPA has defined RACT as the lowest emissions limitation that a
particular source is capable of meeting by the application of control
technology that is reasonably available, considering technological and
economic feasibility. 44 FR 53761 (September 17, 1979). EPA provides
states with guidance concerning what types of controls could constitute
RACT for certain source categories through the issuance of CTGs. See 71
FR 58745, 58747 (October 5, 2006).
    Section 183(e) of the CAA provides that EPA may issue a CTG in lieu
of a national regulation for categories of consumer or commercial
products where the Administrator determines that such guidance will be
substantially as effective as regulations in reducing VOC emissions in
ozone nonattainment areas.

III. EPA's Final Action

    In this rulemaking, EPA is taking final action to approve a
revision to Missouri's VOC rule 10 CSR 10-5.455 into Missouri's SIP, as
EPA believes that this rule satisfies RACT for the Missouri portion of
the St. Louis nonattainment area for Industrial Cleaning Solvents. EPA
also believes that this rule satisfies the requirements of the
conditional approval of Missouri's VOC RACT SIP referenced above. This
final action means that the Missouri SIP meets all of the applicable
VOC RACT requirements for St. Louis under section 182(b)(2) of the Act,
as they relate to the 1997 ozone NAAQS.

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. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely approves state law as meeting Federal requirements and
does not impose additional requirements beyond those imposed by state
law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this rule does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian country located in
the State, and EPA notes that it will not impose substantial direct
costs on tribal governments or preempt tribal law.
    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 CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by March 7, 2014. 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, Incorporation by

reference, Intergovernmental relations, Ozone, Reporting and
recordkeeping requirements, Volatile organic compounds.

    Dated: December 12, 2013.
Karl Brooks,
Regional Administrator, Region 7.

    Chapter I, title 40 of the Code of Federal Regulations 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 AA--Missouri

0
2. Amend Sec.  52.1320 by:
0
a. Revising in paragraph (c) the entry for ``10-5.455'';
0
b. Revising paragraph (e)(55).
    The revisions read as follows:

Sec.  52.1320  Identification of plan.

* * * * *
    (c) * * *

                                        EPA-Approved Missouri Regulations
----------------------------------------------------------------------------------------------------------------
                                                            State
        Missouri citation                  Title          effective     EPA approval date        Explanation
                                                             date
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
10-5.455.........................  Control of Emissions   08/30/2011  1/6/2014 [insert      ....................
                                    from Industrial                    Federal Register
                                    Solvent Cleaning                   page number where
                                    Operations.                        the document
                                                                       begins].

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

* * * * *
    (e) * * *

                               EPA-Approved Missouri Nonregulatory SIP Provisions
----------------------------------------------------------------------------------------------------------------
                                        Applicable          State
    Name of non-regulatory SIP         geographic or      submittal     EPA approval date        Explanation
             revision               nonattainment area       date
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
(55) VOC RACT Requirements for     St. Louis...........   1/17/2007,  1/23/2012, 77 FR      ....................
 the 8-hour ozone NAAQS.                                  6/01/2011,   3144 1/6/2014
                                                           8/30/2011   [insert Federal
                                                                       Register page
                                                                       number where the
                                                                       document begins].

                                                  * * * * * * *
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* * * * *
[FR Doc. 2013-31566 Filed 1-3-14; 8:45 am]
BILLING CODE 6560-50-P