[Federal Register Volume 76, Number 228 (Monday, November 28, 2011)]
[Rules and Regulations]
[Pages 72850-72852]
[FR Doc No: 2011-30540]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

49 CFR Part 225

[FRA-2008-0136, Notice No. 4]
RIN 2130-ZA05

Adjustment of Monetary Threshold for Reporting Rail Equipment
Accidents/Incidents for Calendar Year 2012

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

ACTION: Final rule.

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SUMMARY: This rule increases the rail equipment accident/incident
reporting threshold from $9,400 to $9,500 for certain railroad
accidents/incidents involving property damage that occur during
calendar year 2012. This action is needed to ensure that FRA's
reporting requirements reflect cost increases that have occurred since
the reporting threshold was last published in December of 2010.

DATES: This regulation is effective January 1, 2012.

FOR FURTHER INFORMATION CONTACT: Kebo Chen, Staff Director, U.S.
Department of Transportation, Federal Railroad Administration, Office
of Safety Analysis, RRS-22, Mail Stop 25, West Building 3rd Floor, Room
W33-314, 1200 New Jersey Ave. SE., Washington, DC 20590 (telephone
(202) 493-6079); or Gahan Christenson, Trial Attorney, U.S. Department
of Transportation, Federal Railroad Administration, Office of Chief
Counsel, RCC-10, Mail Stop 10, West Building 3rd Floor, Room W31-204,
1200 New Jersey Ave. SE., Washington, DC 20590 (telephone (202) 493-
1381).

SUPPLEMENTARY INFORMATION:

Background

    A ``rail equipment accident/incident'' is a collision, derailment,
fire, explosion, act of God, or other event involving the operation of
railroad on-track equipment (standing or moving) that results in
damages to railroad on-track equipment, signals, tracks, track
structures, or roadbed, including labor costs and the costs for
acquiring new equipment and material, greater than the reporting
threshold for the year in which the event occurs. 49 CFR 225.19(c).
Each rail equipment accident/incident must be reported to FRA using the
Rail Equipment Accident/Incident Report (Form FRA F 6180.54). 49 CFR
225.19(b) and (c). As revised, effective in 1997, paragraphs (c) and
(e) of 49 CFR 225.19 provide that the dollar figure that constitutes
the reporting threshold for rail equipment accidents/incidents will be
adjusted, if necessary, every year in accordance with the procedures
outlined in appendix B to part 225 to reflect any cost increases or
decreases.

New Reporting Threshold

    Approximately one year has passed since the rail equipment
accident/incident reporting threshold was revised. 75 FR 75911
(December 7, 2010). Consequently, FRA has recalculated the threshold,
as required by Sec.  225.19(c), based on increased costs for labor and
increased costs for equipment. FRA has determined that the current
reporting threshold of $9,400, which applies to rail equipment
accidents/incidents that occur during calendar year 2011, should
increase by $100 to $9,500 for equipment accidents/incidents occurring
during calendar year 2012, effective January 1, 2012. The specific
inputs to the equation set forth in appendix B (i.e., Tnew = Tprior *
[1 + 0.4(Wnew-Wprior)/Wprior + 0.6(Enew-Eprior)/100]) to part 225 are:

----------------------------------------------------------------------------------------------------------------
        Tprior                  Wnew                  Wprior                  Enew                 Eprior
----------------------------------------------------------------------------------------------------------------
             $9,400              $24.92646              $24.73606              186.36666             184.56666
----------------------------------------------------------------------------------------------------------------

    Where: Tnew = New threshold; Tprior = Prior threshold (with
reference to the threshold, ``prior'' refers to the previous threshold
rounded to the nearest $100, as reported in the Federal Register); Wnew
= New average hourly wage rate, in dollars; Wprior = Prior average
hourly wage rate, in dollars; Enew = New equipment average Producer
Price Index (PPI) value; Eprior = Prior equipment average PPI value.
Using the above figures, the calculated new threshold, (Tnew) is
$9,530.47, which is rounded to the nearest $100 for a final new
reporting threshold of $9,500.

Notice and Comment Procedures

    In this rule, FRA has recalculated the monetary reporting threshold
based on the formula discussed in detail and adopted, after notice and
comment, in the final rule published December 20, 2005, 70 FR 75414.
FRA has found that both the current cost data inserted into this pre-
existing formula and the original cost data that they replace were
obtained from reliable Federal government sources. FRA has found that
this rule imposes no additional burden on any person, but rather
provides a benefit by permitting the valid comparison of accident data
over time. Accordingly, finding that notice and comment procedures are
either impracticable, unnecessary, or contrary to the public interest,
FRA is proceeding directly to the final rule.

Regulatory Impact

Executive Orders 12866 and 13563 and DOT Regulatory Policies and
Procedures

    This rule has been evaluated in accordance with existing policies
and procedures, and determined to be non-significant under both
Executive Order 12866 and 13563 in addition to DOT policies and
procedures (44 FR 11034 (Feb. 26, 1979)).

Regulatory Flexibility Act

    The Regulatory Flexibility Act of 1980 (5 U.S.C. 601-612) requires
a review of proposed and final rules to assess their impact on small
entities, unless the Secretary certifies that the rule will not have a
significant economic impact on a substantial number of small entities.
Pursuant to Section 312 of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), FRA has issued a final policy
that formally establishes ``small entities'' as including railroads
that meet the line-haulage revenue requirements of a Class III
railroad. 49 CFR part 209, app. C. For other entities, the same dollar
limit in revenues governs whether a railroad, contractor, or other
respondent is a small entity. Id.
    About 721 of the approximately 754 railroads in the United States
are considered small entities by FRA. FRA certifies that this final
rule will have no significant economic impact on a substantial number
of small entities. To the extent that this rule has any impact on small
entities, the impact will be neutral or insignificant. The frequency of
rail equipment accidents/incidents, and therefore also the frequency of
required reporting, is generally proportional to the size of the
railroad. A railroad that employs thousands of employees and operates
trains millions of miles is exposed to greater risks than one whose
operation is substantially smaller. Small railroads may go for months
at a time without having a reportable occurrence of any type, and even
longer without having a rail equipment accident/incident. For example,
current FRA data indicate that 3,000 rail equipment accidents/incidents
were reported in 2006, with small railroads reporting 379 of them. Data
for 2007 show that 2,694 rail equipment accidents/incidents were
reported, with small railroads reporting 368 of them. Data for 2008
show that 2,478 rail equipment accidents/incidents were reported, with
small railroads reporting 296 of them. In 2009, 1,905 rail equipment
accidents/incidents were reported, and small railroads reported 272 of
them. In 2010, 1,888 rail equipment accidents/incidents were reported,
with small railroads reporting 258 of them. On average for those five
calendar years, small railroads reported about 13% (ranging from 12% to
14%) of the total number of rail equipment accidents/incidents. FRA
notes that these data are accurate as of the date of issuance of this
final rule, and are subject to minor changes due to additional
reporting. Absent this rulemaking (i.e., any increase in the monetary
reporting threshold), the number of reportable accidents/incidents
would increase, as keeping the 2011 threshold in place would not allow
it to keep pace with the increasing dollar amounts of wages and rail
equipment repair costs. Therefore, this rule will be neutral in effect.
Increasing the reporting threshold will slightly decrease the
recordkeeping burden for railroads over time. Any recordkeeping burden
will not be significant and will affect the large railroads more than
the small entities, due to the higher proportion of reportable rail
equipment accidents/incidents experienced by large entities.

Paperwork Reduction Act

    There are no new information collection requirements associated
with this final rule. Therefore, no estimate of a public reporting
burden is required.

Federalism Implications

    Executive Order 13132, entitled, ``Federalism,'' signed on August
4, 1999, requires that each agency ``in a separately identified portion
of the preamble to the regulation as it is to be issued in the Federal
Register, provide[] to the Director of the Office of Management and
Budget a federalism summary impact statement, which consists of a
description of the extent of the agency's prior consultation with State
and local officials, a summary of the nature of their concerns and the
agency's position supporting the need to issue the regulation, and a
statement of the extent to which the concerns of the State and local
officials have been met * * *.'' This rulemaking action has been
analyzed in accordance with the principles and criteria contained in
Executive Order 13132. This rule will not have a substantial direct
effect on States, on the relationship between the National Government
and the States, or on the distribution of power and the
responsibilities among the various levels of government, as specified
in the Executive Order 13132. Accordingly, FRA has determined that this
rule will not have sufficient federalism implications to warrant
consultation with State and local officials or the preparation of a
federalism assessment. Accordingly, a federalism assessment has not
been prepared.

Environmental Impact

    FRA has evaluated this regulation in accordance with its
``Procedures for Considering Environmental Impacts'' (FRA's Procedures)
(64 FR 28545 (May 26, 1999)) as required by the National Environmental
Policy Act (42 U.S.C. 4321 et seq.), other environmental statutes,
Executive Orders, and related regulatory requirements. FRA has
determined that this regulation is not a major FRA action (requiring
the preparation of an environmental impact statement or environmental
assessment) because it is categorically excluded from detailed
environmental review pursuant to section 4(c)(20) of FRA's Procedures.
64 FR 28545, 28547 (May 26, 1999). In accordance with section 4(c) and
(e) of FRA's Procedures, the agency has further concluded that no
extraordinary circumstances exist with respect to this regulation that
might trigger the need for a more detailed environmental review. As a
result, FRA finds that this

regulation is not a major Federal action significantly affecting the
quality of the human environment.

Unfunded Mandates Reform Act of 1995

    Pursuant to Section 201 of the Unfunded Mandates Reform Act of 1995
(Pub. L. 104-4, 2 U.S.C. 1531), each Federal agency ``shall, unless
otherwise prohibited by law, assess the effects of Federal regulatory
actions on State, local, and Tribal governments, and the private sector
(other than to the extent that such regulations incorporate
requirements specifically set forth in law).'' Section 202 of the Act
(2 U.S.C. 1532) further requires that ``before promulgating any general
notice of proposed rulemaking that is likely to result in the
promulgation of any rule that includes any Federal mandate that may
result in expenditure by State, local, and Tribal governments, in the
aggregate, or by the private sector, of [$140,800,000 or more (as
adjusted for inflation)] in any one year, and before promulgating any
final rule for which a general notice of proposed rulemaking was
published, the agency shall prepare a written statement'' detailing the
effect on State, local, and Tribal governments and the private sector.
The final rule will not result in the expenditure, in the aggregate, of
$140,800,000 or more in any one year, and thus preparation of such a
statement is not required.

Energy Impact

    Executive Order 13211 requires Federal agencies to prepare a
Statement of Energy Effects for any ``significant energy action.'' 66
FR 28355 (May 22, 2001). Under the Executive Order, a ``significant
energy action'' is defined as any action by an agency (normally
published in the Federal Register) that promulgates or is expected to
lead to the promulgation of a final rule or regulation, including
notices of inquiry, advance notices of proposed rulemaking, and notices
of proposed rulemaking: That (1)(i) is a significant regulatory action
under Executive Order 12866 or any successor order, and (ii) is likely
to have a significant adverse effect on the supply, distribution, or
use of energy; or (2) that is designated by the Administrator of the
Office of Information and Regulatory Affairs as a significant energy
action. FRA has evaluated this final rule in accordance with Executive
Order 13211. FRA has determined that this final rule is not likely to
have a significant adverse effect on the supply, distribution, or use
of energy. Consequently, FRA has determined that this regulatory action
is not a ``significant energy action'' within the meaning of Executive
Order 13211.

Privacy Act

    Anyone is able to search the electronic form of all our comments
received into any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (Volume 65, Number 70; Pages 19477-78) or you may visit
http://www.regulations.gov.

List of Subjects in 49 CFR Part 225

    Investigations, Penalties, Railroad safety, Reporting and
recordkeeping requirements.

The Rule

    In consideration of the foregoing, FRA amends part 225 of chapter
II, subtitle B of title 49, Code of Federal Regulations, as follows:

PART 225--[AMENDED]

0
1. The authority citation for part 225 continues to read as follows:

    Authority: 49 U.S.C. 103, 322(a), 20103, 20107, 20901-02, 21301,
21302, 21311; 28 U.S.C. 2461, note; and 49 CFR 1.49.

0
2. Amend Sec.  225.19 by revising the first sentence of paragraph (c)
and revising paragraph (e) to read as follows:

Sec.  225.19  Primary groups of accidents/incidents.

* * * * *
    (c) Group II--Rail equipment. Rail equipment accidents/incidents
are collisions, derailments, fires, explosions, acts of God, and other
events involving the operation of on-track equipment (standing or
moving) that result in damages higher than the current reporting
threshold (i.e., $6,700 for calendar years 2002 through 2005, $7,700
for calendar year 2006, $8,200 for calendar year 2007, $8,500 for
calendar year 2008, $8,900 for calendar year 2009, $9,200 for calendar
year 2010, $9,400 for calendar year 2011 and $9,500 for calendar year
2012) to railroad on-track equipment, signals, tracks, track
structures, or roadbed, including labor costs and the costs for
acquiring new equipment and material. * * *
* * * * *
    (e) The reporting threshold is $6,700 for calendar years 2002
through 2005, $7,700 for calendar year 2006, $8,200 for calendar year
2007, $8,500 for calendar year 2008, $8,900 for calendar year 2009,
$9,200 for calendar year 2010, $9,400 for calendar year 2011 and $9,500
for calendar year 2012. The procedure for determining the reporting
threshold for calendar years 2006 and beyond appears as paragraphs 1-8
of appendix B to part 225.
* * * * *

    Issued in Washington, DC, on November 21, 2011.
Joseph C. Szabo,
Administrator.
[FR Doc. 2011-30540 Filed 11-25-11; 8:45 am]
BILLING CODE 4910-06-P


[Federal Register: September 15, 2008 (Volume 73, Number 179)]
[Rules and Regulations]
[Page 53128]
[DOCID:fr15se08-8]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 105

[Docket Nos. TSA-2006-24191; USCG-2006-24196]

Transportation Worker Identification Credential (TWIC)
Implementation in the Maritime Sector, Hazardous Materials Endorsement
for a Commercial Driver's License

Correction

    Document E8-10244 was inadvertently published in the Notices
section of Wednesday, May 7, 2008, beginning on page 25757. It should
have appeared in the Rules and Regulations section.

[FR Doc. Z8-10244 Filed 9-12-08; 8:45 am]

BILLING CODE 1505-01-D


[Federal Register Volume 76, Number 134 (Wednesday, July 13, 2011)]
[Notices]
[Pages 41243-41245]
[FR Doc No: 2011-17613]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OW-2003-0026 FRL-9435-5]

Agency Information Collection Activities: Proposed Collection;
Comment Request; National Water Quality Inventory Reports (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act (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). This ICR is
scheduled to expire on December 31, 2011. 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 September 12, 2011.

ADDRESSES: Submit your comments, identified by Docket ID number EPA-HQ-
OW-2003-0026 by one of the following methods:
     http://www.regulations.gov (our preferred method): Follow
the on-line instructions for submitting comments.
     E-mail<EMAIL_ADDRESS>     Mail: EPA Water Docket, Environmental Protection Agency,
Mailcode (28221-T), 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-OW-2003-
0026 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 http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Alice Mayio, Assessment and Watershed
Protection Division, Office of Water, Mail Code: 4503T, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460;
telephone number:<PHONE_NUMBER>; fax 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 this ICR under Docket ID
number EPA-HQ-OW-2003-0026 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 3334, 1301 Constitution
Ave., NW., Washington, DC. The EPA Docket Center Public Reading Room is
open from 8:30 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 public 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.

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 any technical information and/or data you used
to 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 of 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 are
States, Territories and Tribes with Clean Water Act (CWA)
responsibilities.
    Title: National Water Quality Inventory Reports (Clean Water Act
Sections 305(b), 303(d), 314(a), and 106(e)) (Renewal).
    ICR numbers: EPA ICR Number 1560.10, OMB Control Number 2040-0071.
    ICR status: This ICR is currently scheduled to expire on December
31, 2011. 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, are 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 305(b) reports contain information on the
water quality standards attainment status of assessed waters, and, when
waters are impaired, the pollutants and sources affecting water
quality. This information helps track State progress in controlling
water pollution. Section 303(d) of the Clean Water Act requires States
to identify and rank waters which cannot meet water quality standards
(WQS) following the implementation of technology-based controls. Under
Section 303(d), States are also required to establish total maximum
daily loads (TMDLs) for listed waters not meeting standards as a result
of pollutant discharges. In developing the Section 303(d) lists, States
are required to consider various sources of water quality related data
and information, including the Section 305(b) State water quality
reports. Section 106(e) requires that states annually update monitoring
data and include it in their Section 305(b) report. Section 314(a)
requires states to report on the condition of their publicly-owned
lakes within the Section 305(b) report.
    EPA's Assessment and Watershed Protection Division (AWPD) works
with its Regional counterparts to review and approve or disapprove
State Section 303(d) lists and TMDLs from 56 respondents (the 50
States, the District of Columbia, and the five Territories). Section
303(d) specifically requires States to develop lists and TMDLs ``from
time to time,'' and EPA to review and approve or disapprove the lists
and the TMDLs. EPA also collects State 305(b) reports from 59
respondents (the 50 States, the District of Columbia, five Territories,
and 3 River Basin commissions).
    Tribes are not required to submit 305(b) reports. However, to meet
the needs of Tribes at all levels of development, EPA has prepared
guidance that presents the basic steps a Tribe should take to collect
the water

quality information it needs to make effective decisions about its
program, its goals, and its future directions. Tribal water quality
monitoring and reporting activities are covered under the Section 106
Tribal Grants Program and not included in the burden estimates for this
ICR.
    This announcement includes the re-approval of current, ongoing
activities related to 305(b) and 303(d) reporting and TMDL development
for the period of January 1, 2012 through December 31, 2014. During the
period covered by this ICR renewal, respondents will: complete their
2012 305(b) reports and 2012 303(d) lists; complete their 2014 305(b)
reports and 2014 303(d) lists; transmit annual electronic updates of
ambient monitoring data via the Water Quality Exchange; and continue to
develop TMDLs according to their established schedules. EPA will
prepare biennial Reports to Congress for the 2012 reporting cycle and
for the 2014 cycle, and EPA will review TMDL submissions from
respondents.
    The burdens of specific activities that States undertake as part of
their 305(b) and 303(d) programs are derived from a project among EPA,
States and other interested stakeholders to develop a tool for
estimating the States' resource needs for State water quality
management programs. This project has developed the State Water Quality
Management Workload Model (SWQMWM), which estimates and sums the
workload involved in more than one hundred activities or tasks
comprising a State water quality management program. Over twenty States
contributed information about their activities that became the basis
for the model. According to the SWQMWM, to meet 305(b) and 303(d)
reporting requirements the States will conduct: watershed monitoring
and characterization; modeling and analysis; development of a TMDL
document for public review; public outreach; formal public
participation; tracking; planning; legal support; etc. In general,
respondents have conducted each of these reporting and record keeping
activities for past 305(b) and 303(d) reporting cycles and thus have
staff and procedures in place to continue their 305(b) and 303(d)
reporting programs. The burden associated with these tasks is estimated
in this ICR to include the total number of TMDLs that may be submitted
during the period covered by this ICR.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is expected to average 66,590
hours per response. Burden means the total time, effort, or financial
resources expended by persons to generate, maintain, retain, or
disclose or provide information to or for a Federal agency. This
includes the time needed to review instructions; develop, acquire,
install, and utilize 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 the
information.
    The current ICR provides a detailed explanation of the Agency's
estimate, which is only briefly summarized here:
    Estimated total number of potential respondents: 59.
    Frequency of response: Biannually.
    Estimated total average number of responses for each respondent: 1.
    Estimated total annual burden hours: 3,740,017.
    Estimated total annual costs: $177,837,808. These costs are
entirely attributed to labor, with $0 attributable to capital
investment or maintenance and operational costs.

Are there changes in the estimates from the last approval?

    There is no change expected in the estimates for the total
respondent burden hours identified in the ICR currently approved by
OMB. EPA may revise these burden estimates before submitting this ICR
to OMB based on comments received from the public and updated labor
costs.

What is the next step in the process for this ICR?

    EPA will consider the comments received and amend the ICR as
appropriate. The final ICR package will then be submitted to OMB for
review and approval pursuant to 5 CFR 1320.12. At that time, EPA will
issue another Federal Register notice pursuant to 5 CFR
1320.5(a)(1)(iv) to announce the submission of the ICR to OMB and the
opportunity to submit additional comments to OMB. If you have any
questions about this ICR or the approval process, please contact the
technical person listed under FOR FURTHER INFORMATION CONTACT.

    Dated: June 30, 2011.
Benita Best-Wong,
Acting Director, Office of Wetlands, Oceans, and Watersheds.
[FR Doc. 2011-17613 Filed 7-12-11; 8:45 am]
BILLING CODE 6560-50-P


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<TITLE></TITLE>

Time and Extent Application (TEA)
Review for Ecamsule (Mexoryl SX)
®
Office of Nonprescription Products
Center for Drug Evaluation and Research
•
Food and Drug Administration
Silver Spring
•
MD 20993
CONDITION
Ecamsule (Mexoryl
®
SX), 10%
PHARMACOLOGICAL CLASS
Sunscreen
MONOGRAPH
OTC Sunscreen Drug Products (21 CFR part
352)
APPLICANT
L’Oreal USA Products, Inc.
30 Terminal Avenue
Clark, NJ  07066
SUBMISSION DATE
September 18, 2007
REVIEW DATE
September 25, 2007
REVIEWER
Michael Chasey
TEAM LEADER
Matthew R. Holman, Ph.D.

TEA
Ecamsule (Mexoryl
®
SX)
2
BACKGROUND
The applicant requests addition of ecamsule (Mexoryl
®
SX) in combination with any other active
ingredients listed in 21 CFR 352.10 to the sunscreen monograph (21 CFR part 352).  The
applicant requests that the maximal concentration of this ingredient be 10 percent.  The applicant
does not request any other changes (e.g., labeling or testing) to the sunscreen monograph other
than addition of ecamsule.
REVIEWER’S COMMENTS
The applicant provides basic information about ecamsule, including a detailed chemical
description as required in 21 CFR 330.14(c)(1)(i), as well as a detailed description of the method
of synthesis and purification.  Ecamsule is not included in the U.S. Pharmacopeia-National
Formulary (USP-NF), but the applicant indicates that, a submission was made to the USP on
February 23, 2006, and that the draft is currently undergoing review.
The applicant indicates that ecamsule is or has been marketed in 55 countries.  Of these
countries, ecamsule has been marketed for at least five continuous years in 48 of them.  The
applicant has designated Canada, United Kingdom (including Ireland), France, Italy, and Spain
as “selected countries,” in accordance with 21 CFR 330.14(c)(4).  Ecamsule has been marketed
for over 12 years in each of the “selected countries.”
As indicated in 21 CFR 330.14(b)(2), extent of marketing is determined by the extent to which
sales meets the requirements outlined in 21 CFR 330.14(c)(2)(ii), (c)(2)(iii), and (c)(2)(iv).
These paragraphs collectively address the adequacy of the markets and marketing to reveal
“infrequent but serious ADEs” (adverse drug events) that may occur in the U.S. population if
FDA finds the condition generally recognized as safe and effective (67 FR 3060 at 3065).
As specified in 21 CFR 330.14(c)(2)(ii), the applicant provides the “cumulative total number of
dosage units . . . sold for each dosage form of the condition.”  In this case, the applicant reports
that almost 472 million units of sunscreen products containing ecamsule in combination with
other European Community approved UV filters have been sold in Europe and globally.  The

TEA
Ecamsule (Mexoryl
®
SX)
3
applicant estimates that France, Italy, Spain, United Kingdom (including Ireland), and Germany
market approximately 75 percent of all ecamsule-containing products.  Four of those countries
are included in the applicant’s five “selected countries.”
Table 1.  Estimated sales of ecamsule in sunscreen drug products in “selected countries” (1993-
2006)
Continent
Dosage Units Sold
(in Millions)
North America (2 countries)
20.1
Central/South America (9
countries)
Sales data not
submitted
Europe (26 countries)
451.9
Asia (11 countries)
Sales data not
submitted
Africa (5 countries)
Sales data not
submitted
Australia (1 country)
Sales data not
submitted
Total 472.0
The applicant submitted information on hundreds of labels of sunscreen products containing
ecamsule in combination with other sunscreen active ingredients.  The products include
combinations with eight currently monograph sunscreen active ingredients in addition to three
active ingredients being considered under separate TEAs.  No labeling was submitted in which
ecamsule was the sole active ingredient.
The applicant reports that there have been 24,676 spontaneous adverse event reports from the
approximately 472 million units of ecamsule-containing product formulations sold.  This is an
incidence rate of 0.0052 percent.  They report that this incidence rate is on the order of that
reported for avobenzone, which has reported incidence rate of 0.0067 percent (61 FR 48645 at
48650).  The applicant did not supply any specific information on the types of adverse events
associated with ecamsule-containing products, specifically serious adverse events.  However,
there is information on serious adverse events in new drug applications (NDAs) for ecamsule-
containing products.  There is no data available in the NDAs that would prevent a GRAS

TEA
Ecamsule (Mexoryl
®
SX)
4
determination for ecamsule-containing products. All five of the applicant’s “selected countries”
are listed in Section 802(b)(1)(A) of the Federal Food, Drug, and Cosmetic Act (the Act).
Inclusion in this section of the Act has been interpreted to indicate that the regulatory systems in
these countries are of comparable sophistication to that in the United States (64 FR 71062 at
71068).
The applicant provides specific demographic information about the population in each of the 5
selected countries in tab 5 of the TEA.  This information complies with 21 CFR 330.14(c)(2)(iii),
which requires a description of population demographics “to ensure that the condition’s use(s)
can be reasonably extrapolated to the U.S. population.”  The demographics of the 5 selected
countries represent a diverse population of persons that seems to reflect the diversity of the U.S.
population.
The applicant provides an explanation of the “use pattern,” as required by
21 CFR 330.14(c)(2)(iv).  Use pattern is defined as how often the product is used (according to
the label) and for how long.  The applicant notes that the route of administration is
topical/dermal in a sunscreen formulation for OTC use.  Dosage forms of the final sunscreen
formulation containing ecamsule will be the typical dosage forms for sunscreen products,
including, but not limited to, lotions, creams, sticks, sprays, etc.  The applicant explains that the
directions for use will depend upon the final formulation and will comply with standard
monograph language (21 CFR 352.60).  Additionally, the applicant would like to include under
the “Uses” statement in Drug Facts:
•
“helps provide protection from UVA rays (short and long wavelengths)”
The applicant argues that this statement is currently approved for use in the United States on
ecamsule-containing sunscreen product labeling in NDAs 21-501, 21-502, and 21-471.
RECOMMENDATION
I recommend that ecamsule (Mexoryl
®
SX), 10 percent or less, be considered eligible for review
as an active ingredient, both alone and in combination with GRASE sunscreen active ingredients,

TEA
Ecamsule (Mexoryl
®
SX)
5
in the OTC sunscreen drug product monograph (21 CFR part 352).  To be considered eligible for
review under the TEA process, a product must meet the criteria of marketing for a material time
and to a material extent as set forth in 21 CFR 330.14(b)(2).  Ecamsule meets the requirement for
the material time criteria because ecamsule-containing sunscreen products have been marketed
directly to consumers for over five continuous years in 48 countries.  In addition, ecamsule meets
the criteria for marketing to a material extent because it has been marketed in 55 countries with
an estimated 472 million dosage units of sunscreen products containing ecamsule sold.
In addition to the labeling prescribed by the sunscreen monograph, the applicant would like the
additional claim “helps provide protection from UVA rays (short and long wavelengths).”  This
claim is currently approved in NDAs containing ecamsule.  On August 27, 2007, we published a
proposed rulemaking (PR) that addresses, amongst other things, UVA labeling for sunscreen
products (72 FR 49070).  The labeling proposed by the applicant is similar in nature to the
labeling proposed in the 2007 PR.  Therefore, the applicants claim may be appropriate for OTC
sunscreen products containing ecamsule.  A final determination will be made during review of
submitted safety and efficacy data.


Attachment 17  -  Description of models used to choose attribute levels

Forecasting the attribute levels under different baseline and policy scenarios requires combining the results of different hydrological, biochemical and ecosystem models and represents a significant multi-agency effort.  In summary, plans for land use and management practices are used in a hydrological model to forecast nutrient and sediment loadings to watershed streams, rivers and the Bay.  Forecasts for the water clarity attribute can be taken directly from the hydrological model. Nutrient loadings from the hydrological model are used in a fisheries ecosystem model to forecast the striped bass, blue crab and oyster population attributes.  Nutrient loadings from the hydrological model are also used in a hydrological-biochemical model to forecast levels for the watershed lakes attribute.  The data, models, and resulting output used to forecast future conditions and choose the attribute levels in the choice questions are described in more detail below.

Watershed Implementation Plans (WIPs)
Each of the seven Chesapeake Bay Watershed jurisdictions created WIPs that document how the jurisdiction will meet the water quality standards of the Chesapeake Bay TMDLs.  The WIPs include management practices for agricultural, urban, and forested land and infrastructure improvements affecting storm water and wastewater management.   The WIPs can be viewed at http://www.chesapeakebay.net/about/programs/watershed.

Chesapeake Bay Water Quality Model
The Chesapeake Bay Program Office and other stakeholders use a suite of computer models that project pollution loads and flow. The component models that work together to form the Chesapeake Bay Water Quality Model are described below.  More on the Water Quality Model can be found at http://www.chesapeakebay.net/about/programs/modeling.

Watershed Model
The Watershed Model incorporates information about land use, fertilizer applications, wastewater plant discharges, septic systems, air deposition, farm animal populations, weather and other variables to estimate the amount of nutrients and sediment reaching the Chesapeake Bay and where these pollutants originate.

Estuary Model
The Estuary Model examines the effects that pollution loads generated by the Watershed Model have on water quality. In the Estuary Model, the Chesapeake Bay is represented by more than 57,000 computational cells and is built on two sub-models:
   * The hydrodynamic sub-model simulates the mixing of waters in the Bay and its tidal tributaries.
   * The water quality sub-model calculates the Bay's biological, chemical and physical dynamics.

Scenario Builder
Scenario Builder can generate simulations of the past, present or future state of the Chesapeake Bay watershed to explore potential impacts of management actions and evaluate alternatives.

Scenario Builder produces inputs for the Watershed Model based on factors from a wide range of land uses and management actions. For example, information such as acres of different crops, numbers of animals and extent of conservation practices is used to generate Watershed Model inputs for agricultural land use types.

Airshed Model
The Airshed Model uses information about nitrogen emissions from power plants, vehicles and other sources to estimate the amount of and location where these pollutants are deposited on the Chesapeake Bay and its watershed. That information is fed into the Watershed Model.

Land Change Model
The Land Change Model analyzes and forecasts the effects of urban land use and population on sewer and septic systems in the Chesapeake Bay watershed.

Northeast Lakes Model
The Northeast Lakes model was designed specifically to model changes in the eutrophication of freshwater lakes as the result of management practices aimed at improving the water quality of coastal estuaries.  Combining data from the National Lakes Assessment and results from the Spatially Referenced Regressions On Watershed Attributes (SPARROW) nutrient models, the Northeast Lakes model uses nutrient loads to watershed streams and rivers to forecast eutrophication of lakes in the watershed.  The Northeast Lakes Model places every lake in the Chesapeake Bay watershed into one of four eutrophication categories.  The "low algae growth" lakes on the survey refer to the lower three categories.    The Northeast lakes model is described in more detail in the following peer reviewed publications:

Moore, R. B., C. M. Johnston, R. A. Smith and B. Milstead (2011). "Source and Delivery of Nutrients to Receiving Waters in the Northeastern and Mid-Atlantic Regions of the United States." JAWRA Journal of the American Water Resources Association 47(5): 965-990.http://dx.doi.org/10.1111/j.1752-1688.2011.00582.x

Booth, N. L., E. J. Everman, I. L. Kuo, L. Murphy and L. Sprague (2011). "A Web-Based Decision Support System for Assessing Regional Water-Quality Conditions and Management Actions." J. Am. Water Resour. Assoc. Journal of the American Water Resources Association 47(5): 1136-1150

Chesapeake Bay Ecosystem Fisheries Model (CBFEM)
The CBFEM is a fisheries-oriented trophic network model for the Bay using a widely applied software package, Ecopath with Ecosim, or EwE.  Ecopath is a static, mass-balanced snapshot of the system and Ecosim is a time dynamic simulation module for policy exploration.   The major species for the CBFEM application of EwE include the  multi-stanza (or life-stage) representations of commercially important species (striped bass, bluefish, weakfish, white perch, Atlantic menhaden, blue crab, and oyster) as well as single biomass pool groups of other commercially important species including American eel, Atlantic croaker, summer flounder, spot, alewife, American shad, black drum, catfish, and bivalves.  CBFEM forecasts changes in relative biomass that can be used with current populations to forecast populations in the future.  Documentation for the CBFEM can be found at http://chesapeakebay.noaa.gov/ecosystem-modeling/chesapeake-bay-fisheries-ecosystem-model.


	EPA ICR No. 1759.05                                      OMB Control
No. 2070-0148

Attachment E

Display Related to OMB Control #2070-0148

Listings of Related Regulations in 40 CFR 9.1

As of May 10, 1993, the OMB approval numbers for EPA regulations in
Chapter I of Title 40 of the Code of Federal Regulations (CFR) appear in
a listing in 40 CFR 9.1 (58 FR 27472).  This listing fulfills the
display requirements in section 3507(f) of the Paperwork Reduction Act
(PRA) for EPA regulations.  The listing at 40 CFR 9.1 displays this OMB
Control number for the following regulations:

Program Title 	40 CFR citation

Worker Protection Standards for Agricultural Pesticides	170

____________________________


[Federal Register Volume 84, Number 204 (Tuesday, October 22, 2019)]
[Notices]
[Page 56455]
[FR Doc No: 2019-22970]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER20-122-000]

Crowned Ridge Interconnection, LLC; Supplemental Notice That
Initial Market-Based Rate Filing Includes Request for Blanket Section
204 Authorization

    This is a supplemental notice in the above-referenced proceeding of
Crowned Ridge Interconnection, LLC's application for market-based rate
authority, with an accompanying rate tariff, noting that such
application includes a request for blanket authorization, under 18 CFR
part 34, of future issuances of securities and assumptions of
liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE, Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is November 5, 2019.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
5 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE, Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for electronic review in the
Commission's Public Reference Room in Washington, DC. There is an
eSubscription link on the website that enables subscribers to receive
email notification when a document is added to a subscribed docket(s).
For assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.

    Dated: October 16, 2019.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2019-22970 Filed 10-21-19; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 67 (Monday, April 10, 2017)]
[Proposed Rules]
[Page 17175]
[FR Doc No: 2017-07033]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R04-OAR-2015-0292; FRL-9960-58-Region 4]

Air Plan Approval; Georgia; Inspection and Maintenance Program
Updates

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve the State Implementation Plan (SIP) revision submitted by the
State of Georgia, through the Georgia Environmental Protection Division
on August 6, 2014, pertaining to rule changes for the Georgia
Inspection and Maintenance program. EPA is approving this SIP revision
as modified by GA EPD through a December 1, 2016, partial withdrawal
letter. EPA is proposing this action because the State has demonstrated
that these portions of the SIP revision are consistent with the Clean
Air Act.

DATES: Written comments must be received on or before May 10, 2017.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R04-
OAR-2015-0292 at https://www.regulations.gov. Follow the online
instructions for submitting comments. Once submitted, comments cannot
be edited or removed from Regulations.gov. EPA may publish any comment
received to its public docket. Do not submit electronically any
information you consider to be Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute.
Multimedia submissions (audio, video, etc.) must be accompanied by a
written comment. The written comment is considered the official comment
and should include discussion of all points you wish to make. EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e., on the web, cloud, or other file sharing
system). For additional submission methods, the full EPA public comment
policy, information about CBI or multimedia submissions, and general
guidance on making effective comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Richard Wong, Air Regulatory
Management Section, Air Planning and Implementation Branch, Air,
Pesticides and Toxics Management Division, U.S. Environmental
Protection Agency, Region 4, 61 Forsyth Street SW., Atlanta, Georgia
30303-8960. Mr. Wong can be reached via telephone at<PHONE_NUMBER> or
via electronic mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In the Final Rules Section of this Federal
Register, EPA is approving the State's August 6, 2014 SIP revision as a
direct final rule without prior proposal because the Agency views this
as a noncontroversial submittal and anticipates no adverse comments. As
discussed in the direct final rule, GA EPD submitted a partial
withdrawal letter to EPA on December 1, 2016, withdrawing the proposed
revision to Georgia Rule 391-3-20-.06, ``On Road Testing,'' from the
SIP revision. Therefore, that rule is no longer part of the SIP
revision that EPA is proposing to approve. A detailed rationale for the
approval is set forth in the direct final rule and incorporated herein
by reference. If no adverse comments are received in response to this
rule, no further activity is contemplated. If EPA receives adverse
comments, the direct final rule will be withdrawn and all adverse
comments received will be addressed in a subsequent final rule based on
this proposed rule. EPA will not institute a second comment period on
this document. Any parties interested in commenting on this document
should do so at this time.

    Dated: March 15, 2017.
V. Anne Heard,
Acting Regional Administrator, Region 4.
[FR Doc. 2017-07033 Filed 4-7-17; 8:45 am]
BILLING CODE 6560-50-P