[Federal Register Volume 80, Number 246 (Wednesday, December 23, 2015)]
[Notices]
[Pages 79885-79886]
[FR Doc No: 2015-32179]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OECA-2012-0529; FRL-9939-73-OEI]

Information Collection Request Submitted to OMB for Review and
Approval; Comment Request; NESHAP for Mercury (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency has submitted an
information collection request (ICR), ``NESHAP for Mercury (40 CFR part
61, subpart E) (Renewal)'' (EPA ICR No. 0113.12, OMB Control No. 2060-
0097), to the Office of Management and Budget (OMB) for review and
approval in accordance with the Paperwork Reduction Act (44 U.S.C. 3501
et seq.). This is a proposed extension of the ICR, which is currently
approved through December 31, 2015. Public comments were previously
requested via the Federal Register (80 FR 32116) on June 5, 2015 during
a 60-day comment period. This notice allows for an additional 30 days
for public comments. A fuller description of the ICR is given below,
including its estimated burden and cost to the public. 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.

DATES: Additional comments may be submitted on or before January 22,
2016.

ADDRESSES: Submit your comments, referencing Docket ID Number EPA-HQ-
OECA-2012-0529, to: (1) EPA online using www.regulations.gov (our
preferred method), or by email to<EMAIL_ADDRESS>or by mail to:
EPA Docket Center, Environmental Protection Agency, Mail Code 28221T,
1200 Pennsylvania Ave. NW., Washington, DC 20460; and (2) OMB via email
to<EMAIL_ADDRESS>Address comments to OMB Desk Officer
for EPA.
    EPA's policy is that all comments received will be included in the
public docket without change including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be Confidential Business Information (CBI), or other
information whose disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: Patrick Yellin, Monitoring,
Assistance, and Media Programs Division, Office of Compliance, Mail
Code 2227A, Environmental Protection Agency, 1200

Pennsylvania Ave. NW., Washington, DC 20460; telephone number: (202)
564-2970; fax number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Supporting documents which explain in detail
the information that the EPA will be collecting are available in the
public docket for this ICR. The docket can be viewed online at
www.regulations.gov or in person at the EPA Docket Center, WJC West,
Room 3334, 1301 Constitution Ave. NW., Washington, DC. The telephone
number for the Docket Center is<PHONE_NUMBER>. For additional
information about EPA's public docket, visit: http://www.epa.gov/dockets.
    Abstract: Owners and operators of affected facilities are required
to comply with both reporting and record-keeping requirements for the
general provisions (40 CFR part 61, subpart A), as well as for the
requirements in 40 CFR part 61, subpart E. This includes submitting
initial notification reports, performance tests and periodic reports
and results, and maintaining records of the occurrence and duration of
any startup, shutdown, or malfunction in the operation of an affected
facility, or any period during which the monitoring system is
inoperative. These reports are used by EPA to determine compliance with
the standards.
    Form Numbers: None.
    Respondents/affected entities: Mercury ore processing facilities,
mercury cell chlor-alkali plants, sludge incineration plants, and
sludge drying plants.
    Respondent's obligation to respond: Mandatory (40 CFR part 61,
subpart E).
    Estimated number of respondents: 107 (total).
    Frequency of response: Initially, occasionally, semiannually and
annually.
    Total estimated burden: 20,600 hours (per year). Burden is defined
at 5 CFR 1320.3(b).
    Total estimated cost: $2,070,000 (per year). There are no
annualized capital/startup and operation & maintenance costs.
    Changes in the Estimates: There is a small increase in the
respondent burden due to an adjustment. In this ICR, we assume all
existing sources will take some time each year to re-familiarize
themselves with the regulatory requirements. This new assumption
results in an increase in the labor hours and cost.

Courtney Kerwin,
Acting Director, Collection Strategies Division.
[FR Doc. 2015-32179 Filed 12-22-15; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 78, Number 59 (Wednesday, March 27, 2013)]
[Rules and Regulations]
[Pages 18478-18479]
[FR Doc No: 2013-07002]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2013-0152]

Drawbridge Operation Regulations; Snohomish River, Everett, WA

AGENCY: Coast Guard, DHS.

ACTION: Notice of deviation from drawbridge regulation.

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SUMMARY: The Coast Guard has issued a temporary deviation from the
operating schedule that governs the SR 529 Bridges across the Snohomish
River, mile 3.6 near Everett, WA. The deviation is necessary to
facilitate heavy maintenance and equipment upgrades on the bridges.
This deviation allows the bridges to remain in the closed position
during maintenance activities.

DATES: This deviation is effective from 12:01 a.m. on May 3, 2013,
until 11:59 p.m. June 21, 2013.

ADDRESSES: The docket for this deviation, [USCG-2013-0152] is available
at http://www.regulations.gov. Type the docket number in the ``SEARCH''
box and click ``SEARCH.'' Click on Open Docket Folder on the line
associated with this deviation. You may also visit the Docket
Management Facility in Room W12-140 on the ground floor of the
Department of Transportation West Building, 1200 New Jersey Avenue SE.,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary deviation, call or email Randall Overton, Coast Guard
Thirteenth District, Bridge Administrator; telephone<PHONE_NUMBER>,
email<EMAIL_ADDRESS>If you have questions on viewing the
docket, call Barbara Hairston, Program Manager, Docket Operations,
telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Washington State Department of
Transportation (WSDOT) has requested that the SR 529 Bridges across the
Snohomish River remain closed to vessel traffic to facilitate heavy
maintenance and equipment upgrades on the bridges. The SR 529 Bridges
cross the Snohomish River at mile 3.6 and provide 38 feet of vertical
clearance above mean high water elevation while in the closed position.
Vessels that do not require a bridge opening may continue to transit
beneath the bridges during this closure period. Under normal conditions
the SR 529 Bridges crossing the Snohomish River operate in accordance
with 33 CFR 117.1059(c) which requires advance notification of one-hour
when a bridge opening is needed. This deviation period is effective
from 12:01 a.m. on May 3, 2013, until 11:59 p.m. June 21, 2013. The
deviation allows the SR 529 Bridges crossing the Snohomish River, to
remain in the closed position and need not open for maritime traffic
from 12:01 a.m. on May 3, 2013, until 11:59 p.m. June 21, 2013. The
bridges shall operate in accordance to 33 CFR 117.1059 at all other
times. Waterway usage on the Snohomish River includes vessels ranging
from commercial tug and barge to small pleasure craft. Mariners will be
notified and kept informed of the

bridges' operational status via the construction contractor performing
the maintenance as well as via the Coast Guard Notice to Mariners
publication and Broadcast Notice to Mariners as appropriate. The
bridges will not be able to open during this maintenance activity
because the lifting mechanisms will be inoperable.
    In accordance with 33 CFR 117.35(e), the drawbridges must return to
their regular operating schedule immediately at the end of the
effective period of this temporary deviation. This deviation from the
operating regulations is authorized under 33 CFR 117.35.

    Dated: March 14, 2013.
Randall D. Overton,
Bridge Administrator, Thirteenth Coast Guard District.
[FR Doc. 2013-07002 Filed 3-26-13; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register: January 24, 2008 (Volume 73, Number 16)]
[Notices]
[Page 4209-4210]
[DOCID:fr24ja08-75]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OA-2007-0706; FRL-8520-1]

Agency Information Collection Activities; Submission to OMB for
Review and Approval; Comment Request; State Small Business Stationary
Source Technical and Environmental Compliance Assistance Programs
(SBTCP) Annual Reporting Form (Renewal); EPA ICR No. 1748.05, OMB
Control No. 2060-0337

AGENCY: Environmental Protection Agency.

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act (PRA) (44
U.S.C. 3501 et seq.), this document announces that an Information
Collection Request (ICR) has been forwarded to the Office of Management
and Budget (OMB) for review and approval. This is a request to renew an
existing approved collection. The ICR, which is abstracted below,
describes the nature of the information collection and its estimated
burden and cost.

DATES: Additional comments may be submitted on or before February 25,
2008.

ADDRESSES: Submit your comments, referencing Docket ID No. EPA-HQ-OA-
2007-0706, to: (1) EPA online using http://www.regulations.gov (our preferred method), by e-mail to<EMAIL_ADDRESS>or by mail to: EPA Docket

Center, Office of Environmental Information Docket (2822T),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460, and (2) OMB by mail to: Office of Information and
Regulatory Affairs, Office of Management and Budget (OMB), Attention:
Desk Officer for EPA, 725 17th Street, NW., Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT: Angela Suber, Office of Small and
Disadvantaged Business Utilization, 1230T, Environmental Protection
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone
number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>Environmental Protection Agency, 1200

Pennsylvania Ave., NW., Washington, DC 20460.

SUPPLEMENTARY INFORMATION: EPA has submitted the following ICR to OMB
for review and approval according to the procedures prescribed in 5 CFR
1320.12. On September 25, 2007, (72 FR 54444), EPA sought comments on
this ICR pursuant to 5 CFR 1320.8(d). EPA received no comments during
the comment period. Any additional comments on this ICR should be
submitted to EPA and OMB within 30 days of this notice.
    EPA has established a public docket for this ICR under Docket ID
No. EPA-HQ-OA-2007-0706, which is available for online viewing at
http://www.regulations.gov, or in person viewing at the Office of

Environmental Information (OEI) Docket in the EPA Docket Center (EPA/
DC), EPA West, Room 3334, 1301 Constitution Ave., NW., Washington, DC.
The EPA/DC 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<PHONE_NUMBER>, and the telephone number for the
OEI Docket is<PHONE_NUMBER>.
    Use EPA's electronic docket and comment system at
http://www.regulations.gov, to submit or view public comments, access the

index listing of the contents of the docket, and to access those
documents in the docket that are available electronically. Once in the
system, select ``docket search,'' then key in the docket ID number
identified above. Please note that EPA's policy is that public
comments, whether submitted electronically or in paper, will be made
available for public viewing at http://www.regulations.gov as EPA receives

them and without change, unless the comment contains copyrighted
material, Confidential Business Information (CBI), or other information
whose public disclosure is restricted by statute. For further
information about the electronic docket, go to http://www.regulations.gov.

    Title: State Small Business Stationary Source Technical and
Environmental Compliance Assistance Programs (SBTCP) Annual Reporting
Form (Renewal).
    ICR numbers: EPA ICR No. 1748.05, OMB Control No. 2060-0337.
    ICR Status: This ICR is scheduled to expire on November 30, 2007.
Under OMB regulations, the Agency may continue to conduct or sponsor
the collection of information while this submission is pending at OMB.
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: As part of the Clean Air Act Amendments of 1990, the U.S.
Congress included, as part of Section 507, the requirement that each
state establish a Small Business Stationary Source Technical and
Environmental Compliance Assistance Program to assist small businesses
in complying with the Act. These programs are generally known as state
Small Business Environmental Assistance Programs (SBEAP). EPA must
provide the Congress with periodic reports from the EPA Small Business
Ombudsman (SBO) on these programs, including their effectiveness,
difficulties encountered, and other relevant information. Each state
assistance program will submit requested information to EPA for
compilation and summarization. This collection of information is
mandatory under Section 507(a), (d), and (e) of the Clean Air Act as
amended in 1990, Public Law 101-549, November 15, 1990. This Act
directs EPA to monitor

the state SBEAPs and to periodically report to Congress on the
effectiveness of these programs. This responsibility has been delegated
to the EPA SBO. Information in the annual Report to Congress is
aggregated and is not of a confidential nature. None of the information
collected by this action results in/or requests sensitive information
of any nature from the states.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average 80
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 which have subsequently changed; 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.
    Respondents/Affected Entities: State Small Business Stationary
Source Technical and Environmental Compliance Assistance Programs
(SBTCP).
    Estimated Number of Respondents: 53.
    Frequency of Response: Annual.
    Estimated Total Annual Hour Burden: 4,240.
    Estimated Total Annual Cost: $144,997, includes $0 annualized
capital or O&M costs.
    Changes in the Estimates: There is an increase of 2,120 hours in
the total estimated burden currently identified in the OMB Inventory of
Approved ICR Burdens. The new total estimate of 80 hours per state to
complete the Annual Survey Form presented in this ICR represents an
increase of 40 hours from what was estimated to complete the previous
form. A workgroup comprising representatives from several state 507
programs reviewed the reporting form and the burden estimates for this
ICR. The group determined that the burden to complete the previous form
was underestimated and the addition of new outcome measures to the
revised form will require additional time to track and report. The new
burden estimate represents an increase to 54 hours to complete the
information requested in the previous form and an additional 26 hours
to complete the new program outcome measures recommended by the state
507 programs.

    Dated: January 17, 2008.
Sara Hisel-McCoy,
Director, Collection Strategies Division.
[FR Doc. E8-1186 Filed 1-23-08; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register: August 30, 2007 (Volume 72, Number 168)]
[Rules and Regulations]
[Page 50059-50063]
[DOCID:fr30au07-7]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R01-OAR-2007-0373; A-1-FRL-8461-5]

Approval and Promulgation of Air Quality Implementation Plans;
Connecticut; Establishment of Interim Progress for the Annual Fine
Particle National Ambient Air Quality Standard

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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SUMMARY: The EPA is approving a State Implementation Plan (SIP)
revision submitted by the State of Connecticut. This revision
establishes early fine particulate (PM2.5) transportation
conformity emission budgets for the Connecticut portion of the New
York-Northern New Jersey-Long Island, NY-NJ-CT PM2.5
nonattainment area. This action is being taken under the Clean Air Act.

DATES: This direct final rule will be effective October 29, 2007,
unless EPA receives adverse comments by October 1, 2007. If adverse
comments are received, EPA will publish a timely withdrawal of the
direct final rule in the Federal Register informing the public that the
rule will not take effect.

ADDRESSES: Submit your comments, identified by Docket ID Number EPA-
R01-OAR-2007-0373 by one of the following methods:
    1. http://www.regulations.gov: Follow the on-line instructions for

submitting comments.
    2. E-mail<EMAIL_ADDRESS>    3. Fax:<PHONE_NUMBER>.
    4. Mail: ``Docket Identification Number EPA-R01-OAR-2007-0373'',
Anne Arnold, U.S. Environmental Protection Agency, EPA New England
Regional Office, One Congress Street, Suite 1100 (mail code CAQ),
Boston, MA 02114-2023.
    5. Hand Delivery or Courier. Deliver your comments to: Anne Arnold,
Manager, Air Quality Planning Unit, Office of Ecosystem Protection,
U.S. Environmental Protection Agency, EPA New England Regional Office,
One Congress Street, 11th floor, (CAQ), Boston, MA 02114-2023. Such
deliveries are only accepted during the Regional Office's normal hours
of operation. The Regional Office's official hours of business are
Monday through Friday, 8:30 a.m. to 4:30 p.m., excluding legal
holidays.
    Instructions: Direct your comments to Docket ID No. EPA-R01-OAR-
2007-0373. 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 through
http://www.regulations.gov, or e-mail, information that you consider to be CBI

or otherwise protected. The http://www.regulations.gov Web site is an

``anonymous access'' systems, 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.
    Docket: All documents in the electronic docket are listed in the
http://www.regulations.gov index. Although listed in the index, some

information is not publicly available, i.e., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available either electronically in http://www.regulations.gov or

in hard copy at Office of Ecosystem Protection, U.S. Environmental
Protection Agency, EPA New England Regional Office, One Congress
Street, Suite 1100, Boston, MA. EPA requests that if at all possible,
you contact the contact listed in the FOR FURTHER INFORMATION CONTACT
section to schedule your inspection. The Regional Office's official
hours of business are Monday through Friday, 8:30 a.m. to 4:30 p.m.,
excluding legal holidays.
    In addition, copies of the state submittal are also available for
public inspection during normal business hours, by appointment at the
State Air Agency, the Bureau of Air Management, Department of
Environmental Protection, State Office Building, 79 Elm Street,
Hartford, CT 06106-1630.

FOR FURTHER INFORMATION CONTACT: Donald O. Cooke, Air Quality Planning
Unit, U.S. Environmental Protection Agency, EPA New England Regional
Office, One Congress Street, Suite 1100 (CAQ), Boston, MA 02114-2023,
telephone number<PHONE_NUMBER>, fax number<PHONE_NUMBER>, e-mail
<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION: Organization of this document. The following
outline is provided to aid in locating information in this preamble.

I. Background and Purpose
II. Comparison of Year 2002 Emissions to Year 2009
III. Adequacy Process and SIP Approval
IV. Transportation Conformity Motor Vehicle Emissions Budgets
V. Basis for Approval
VI. Final Action
VII. Statutory and Executive Order Reviews

I. Background and Purpose

    On December 17, 2004, (69 FR 943; January 5, 2005), EPA designated
the New York-Northern New Jersey-Long Island, NY-NJ-CT area as
nonattainment for the annual National Ambient Air Quality Standards
(NAAQSs) for fine particle pollution or PM2.5. [Airborne
particles less than or equal to 2.5 micrometers in diameter are
considered to be ``fine particles,'' also referred to as
PM2.5.] One year after the April 5, 2005 effective date of
the PM2.5 designations, transportation conformity applies to
this multi-state PM2.5 nonattainment area. Within three
years of final designation, (by April 5, 2008), consistent with section
172(b) of the Clean Air Act, and 40 CFR 51.1002 of the PM2.5
implementation regulations, the States of New Jersey, New York and
Connecticut are required to submit an attainment demonstration and
adopted regulations ensuring that the New York-Northern New Jersey-Long
Island, NY-NJ-CT PM2.5 nonattainment area will attain the
National Ambient Air Quality Standards as expeditiously as practicable.
This PM2.5 attainment demonstration must include motor
vehicle emissions budgets for direct PM2.5 (including re-
entrained road dust and/or highway and transit construction dust if
determined significant contributors), and any PM2.5
precursors determined to be significant (which may include nitrogen
oxides (NOX), volatile organic compounds (VOC), sulfur
dioxide (SO2) and ammonia (NH3)). The SIP must
clearly identify the budgets (motor vehicle emissions budgets) for
transportation conformity purposes.
    In the June 8, 2006 Federal Register (71 FR 33305), EPA announced
that the direct PM2.5 and NOX motor vehicle
emissions budgets identified in New Jersey's PM2.5 early
progress state implementation plan (SIP) for the New Jersey portion of
the NY-NJ-CT PM2.5 nonattainment area were adequate for
transportation conformity purposes. As a result of EPA's adequacy
finding, the two metropolitan planning organizations in northern New
Jersey (the North Jersey Transportation Planning Authority (NJTPA) and
the Delaware Valley Regional Planning Commission (DVRPC)) must use the
new 2009 direct PM2.5 and NOX budgets from the
early progress PM2.5 SIP for future conformity
determinations. In addition, with the establishment of adequate motor
vehicle emissions budgets, New Jersey can independently determine
conformity for the New Jersey portion of the NY-NJ-CT PM2.5
nonattainment area and is no longer tied to New York and Connecticut
for transportation conformity determinations. On July 10, 2006, EPA
approved the PM2.5 motor vehicle emissions budgets for
Northern New Jersey into the New Jersey SIP (71 FR 38770).
    On April 17, 2007, the Connecticut Department of Environmental
Protection (DEP) submitted a revision to its SIP for establishing early
fine particulate (PM2.5) transportation conformity emission
budgets for the Connecticut portion of the New York-Northern New
Jersey-Long Island, NY-NJ-CT PM2.5 nonattainment area. This
SIP revision was developed in accordance with EPA's transportation
conformity rule (69 FR 40028; July 1, 2004), which allows states with
PM2.5 nonattainment areas to adopt early motor vehicle
emission budgets that address the annual PM2.5 NAAQSs in
advance of a complete SIP attainment demonstration. This SIP revision
establishes early budgets to simplify the conformity process for
Connecticut Metropolitan Planning Organizations (MPOs) while increasing
the level of protection for Connecticut's citizens during this interim
period before PM2.5 attainment plans are due in April 2008.
    The PM2.5 motor vehicle emission budgets for calendar
year 2009 included in Connecticut's April 17, 2007 SIP revision apply
to MPOs in the Connecticut counties of Fairfield and New Haven. Before
these budgets were determined adequate (see Section C below), these
Connecticut MPOs were required to determine conformity jointly with the
New York MPOs included in the NY-NJ-CT PM2.5 nonattainment
area based on a calendar year 2002 interim baseline budget test.
Consistent with a supplemental EPA rulemaking on

transportation conformity (70 FR 24280; May 6, 2005), Connecticut's
April 17, 2007 SIP revision establishes early motor vehicle budgets for
direct PM2.5 emissions and for emissions of nitrogen oxides
(NOX) [the only PM2.5 precursor found to be
significant at this time for onroad mobile sources]. Since the budgets
have been determined adequate, Connecticut MPOs must demonstrate that
all transportation plans result in emissions of PM2.5 and
NOX that do not exceed the annual 2009 motor vehicle
emissions budget levels.

II. Comparison of Year 2002 Emissions to Year 2009

    The total inventory of direct PM2.5 emissions for the
Connecticut portion of the NY-NJ-CT PM2.5 nonattainment Area
is 6,663 tons in calendar year 2002, and is projected to be 6,495 tons
in calendar year 2009. This represents an overall inventory reduction
of 2.5% (168 tons of direct PM2.5 emissions). Table 1,
below, compares calculated year 2002 and year 2009 direct
PM2.5 inventories by source type for the Connecticut portion
of the NY-NJ-CT PM2.5 nonattainment area. Although direct
PM2.5 emissions from area and point sources are projected to
increase by two and eight percent, respectively, emissions from nonroad
and onroad sources are projected to decrease by 13 and 31 percent,
respectively.

                                                         Table 1.--Direct Annual PM2.5 Emissions
                                                                         [Tons]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                          Area                 Nonroad                Point                Onroad
                                                                 ---------------------------------------------------------------------------------------
                                                                     2002       2009       2002       2009       2002       2009       2002       2009
--------------------------------------------------------------------------------------------------------------------------------------------------------
Fairfield County................................................      2,349      2,388        526        454        190        202        269        185
New Haven County................................................      2,427      2,476        448        395        202        220        252        175
                                                                 ---------------------------------------------------------------------------------------
Total for CT Portion of NY-NJ-CT PM2.5 Nonattainment Area.......      4,776      4,864        974        849        392        422        521        360
--------------------------------------------------------------------------------------------------------------------------------------------------------

    The total inventory of NOX emissions for the Connecticut
portion of the NY-NJ-CT PM2.5 nonattainment area is 61,199
tons in calendar year 2002, and projected to be 44,433 tons in calendar
year 2009. This represents an overall inventory reduction of 27%
(16,766 tons of NOX emissions). Table 2, below, compares
calculated 2002 and 2009 annual NOX inventories by source
type for the Connecticut portion of the NY-NJ-CT PM2.5
nonattainment area. Although NOX emissions from area and
point sources are projected to increase by four and seven percent,
respectively, emissions from nonroad and onroad sources are projected
to decrease by 12 and 46 percent, respectively.

                                                             Table 2.--Annual NOX Emissions
                                                                         [Tons]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                          Area                 Nonroad                Point                Onroad
                                                                 ---------------------------------------------------------------------------------------
                                                                     2002       2009       2002       2009       2002       2009       2002       2009
--------------------------------------------------------------------------------------------------------------------------------------------------------
Fairfield County................................................      3,134      3,269      7,150      6,104      3,892      4,183     17,411      9,314
New Haven County................................................      2,937      3,061      7,935      7,108      2,305      2,429     16,435      8,965
                                                                 ---------------------------------------------------------------------------------------
Total for CT Portion of NY-NJ-CT PM2.5 Nonattainment Area.......      6,071      6,330     15,085     13,212      6,197      6,612     33,846     18,279
--------------------------------------------------------------------------------------------------------------------------------------------------------

III. Adequacy Process and SIP Approval

    On March 2, 1999, the United States Court of Appeals for the
District of Columbia Circuit issued a decision on EPA's third set of
transportation conformity amendments in response to a case brought by
the Environmental Defense Fund. The decision held that conformity
determinations could no longer be based on submitted SIP emissions
budgets, prior to a positive adequacy determination by EPA.
    A May 14, 1999, EPA memorandum from Gay MacGregor to the Regional
Division Directors provides guidance on how to review budgets for
adequacy and the process for public comment and notification (posting
on the Web). The May 14, 1999 guidance is available on EPA's conformity
Web site at URL address: http://www.epa.gov/otaq/stateresources/transconf/policy/epaguidf.pdf.
 EPA provided additional guidance in its

Final Rulemaking on July 1, 2004 (69 FR 40004-40081) ``Transportation
Conformity Rule Amendments for the New 8-hour Ozone and
PM2.5 National Ambient Air Quality Standards and
Miscellaneous Revisions for Existing Areas; Transportation Conformity
Rule Amendments: Response to Court Decision and Additional Rule
Changes; Final Rule.''
    EPA initiated the adequacy process for Connecticut's motor vehicle
emissions budgets on April 19, 2007, by announcing that Connecticut had
submitted an early progress SIP for PM2.5 on EPA's Web site
``SIP Submissions Currently Under EPA Adequacy Review'' http://www.epa.gov/otaq/stateresources/transconf/currsips.htm.
 The criteria by

which EPA determines whether a SIP's motor vehicle emission budgets are
adequate for conformity purposes are outlined in 40 CFR 93.118(e)(4)(i)
through 93.118(e)(4)(vi) and 93.118(e)(5). On May 24, 2007, EPA
notified the Connecticut Department of Environmental Protection (CT
DEP) that no comments were received during the thirty day public
comment period, and that EPA had determined the 2009 motor vehicle
emissions budgets submitted on April 17, 2007, to be adequate for
transportation conformity purposes. EPA New England published a Notice
of Adequacy Federal Register on Tuesday, June 5, 2007 (72 FR 31069),
announcing our May 24, 2007 adequacy determination and making the motor
vehicle emissions budgets effective on June 20, 2007. A copy of EPA's
May 24, 2007 adequacy determination to CT DEP

and the Federal Register Notice of Adequacy are both posted in the
electronic docket as well as on EPA's Web site ``SIP Submissions that
EPA has Found Adequate or Inadequate,'' at URL address: http://www.epa.gov/otaq/stateresources/transconf/pastsips.htm
.

    This positive adequacy determination simplifies the administrative
process for demonstrating transportation conformity by establishing the
2009 direct PM2.5 and NOX motor vehicle emissions
budgets as conformity criteria for all 2009 and later evaluation years.
Connecticut's early motor vehicle emissions budgets will insure
progress is made towards achieving and maintaining the PM2.5
NAAQS by limiting the transportation sector to a more restrictive year
2009 level of on-road direct PM2.5 and NOX than
currently allowed by transportation conformity's interim emissions
tests which are based on 2002 emissions in the New York and Connecticut
portions of the nonattainment area. Connecticut will also be able to
evaluate conformity independently and will no longer be required to re-
evaluate conformity whenever a MPO in the New York portion of the New
York-Northern New Jersey-Long Island, NY-NJ-CT PM2.5
nonattainment area triggers conformity. EPA's adequacy determination
for New Jersey's PM2.5 motor vehicle emissions budgets (71
FR 33305; June 8, 2006) already allows New Jersey to independently
determine conformity.
    Today's direct final rulemaking approves Connecticut's adequate
2009 direct PM2.5 and NOX motor vehicle emissions
budgets into the Connecticut SIP.

IV. Transportation Conformity Motor Vehicle Emissions Budgets

    The early direct PM2.5 and NOX annual motor
vehicle emissions budgets being established are the on-road portion of
the 2009 projections illustrated in Table 3, below, 360 tons per year
for direct PM2.5 and 18,279 tons per year for
NOX. The State of Connecticut Department of Transportation
and Metropolitan Planning Organizations within the Connecticut portion
of the NY-NJ-CT PM2.5 nonattainment area [Council of
Governments of the Central Naugatuck Valley (portion), Greater
Bridgeport and Valley Regional Planning Organizations, Housatonic
Valley Council of Elected Officials (portion), South Central Regional
Council of Governments, and South Western Regional Planning Agency],
shall use these budgets for future transportation conformity
determinations.

        Table 3.--2009 Transportation Conformity Emission Budgets
------------------------------------------------------------------------
                                           Annual direct
                                               PM2.5        Annual NOX
                                             emissions       emissions
                                              (tons)          (tons)
------------------------------------------------------------------------
Connecticut Portion of the NY-NJ-CT                  360          18,279
 PM2.5 Nonattainment Area...............
------------------------------------------------------------------------

V. Basis for Approval

    EPA's review of Connecticut's SIP revision concludes that this SIP
revision is consistent with EPA's Transportation Conformity Rule.
Approval of Connecticut's SIP revision is directionally sound since it
would approve year 2009 motor vehicle emissions budgets which are more
stringent than the year 2002 baseline emissions now used to evaluate
transportation conformity in the NY-NJ-CT PM2.5
nonattainment area. The projected overall annual inventory reduction in
direct PM2.5 emissions from 2002 to 2009 is approximately
2.5 percent, along with a 27 percent reduction in NOX
emissions. This results from a projected 31 percent reduction in direct
PM2.5 emissions and a 46 percent reduction in NOX
emissions from onroad sources.
    Connecticut's projected reduction in direct PM2.5 and
NOX emissions demonstrates progress towards attainment of
the PM2.5 annual standard. Although, the projected reduction
in direct PM2.5 emissions is below the five to ten percent
reduction that was provided as an example in the July 2004 conformity
rule preamble (69 FR 40019; July 1, 2004), EPA believes that
Connecticut's early progress SIP should be approved since it will
strengthen the existing SIP. Listed below are several factors that make
Connecticut's SIP package directionally sound.
    1. Fairfield County and New Haven County were included in the New
York-Northern New Jersey-Long Island, NY-NJ-CT PM2.5
nonattainment area because of traffic and commuting patterns and other
weighting factors used in EPA's designation process. Connecticut has
never monitored values at or above the annual NAAQSs for
PM2.5.\1\
---------------------------------------------------------------------------

    \1\ This SIP is addressing requirements for the annual
PM2.5 standard. Nonattainment of the revised 24-hour
PM2.5 standard (35 micrograms per cubic meter of air
([mu]g/m3)) has not yet been determined.
---------------------------------------------------------------------------

    2. There were no monitored violations of EPA's annual
PM2.5 standard in Fairfield and New Haven counties in 2002,
and any reduction in the overall inventory for the two county area
below 2002 levels should help ensure that this level of air quality is
maintained or improved in the future.
    3. There is a significant projected tonnage decrease in overall
PM2.5 emissions (168 tons) and NOX emissions
(16,766 tons) by 2009 in comparison to 2002 base year levels.
    4. There is a very large percent reduction projected in both
PM2.5 direct and NOX on-road emissions (31% and
46%, respectively) and traffic and commuting patterns were one of the
areas highlighted in the technical support documentation for EPA's
PM2.5 designation decisions.
    5. The large reduction in Connecticut's NOX emissions
(27% overall reduction from all inventory sources) may be more
beneficial to transport issues by reducing precursors, than immediate
reduction of direct PM2.5 emissions in Connecticut.

VI. Final Action

    EPA is approving the Connecticut SIP revision for establishment of
interim progress for the annual fine particle National Ambient Air
Quality Standard, which was submitted on April 17, 2007. The direct
PM2.5 and annual NOX motor vehicle emissions
budgets being approved are the on-road mobile source 2009 projections
of 360 tons per year of direct PM2.5 and 18,279 tons per
year of NOX. These motor vehicle emissions budgets must be
used to demonstrate that all transportation plans in the Connecticut
portion of the NY-NJ-CT PM2.5 nonattainment area result in
emissions of PM2.5 and NOX that do not exceed the
annual 2009 motor vehicle emissions budget levels.
    The EPA is publishing this rule without prior proposal because the
Agency views this as a noncontroversial amendment and anticipates no
adverse

comments. However, in the proposed rules section of this Federal
Register publication, EPA is publishing a separate document that will
serve as the proposal to approve the SIP revision should adverse
comments be filed. This action will be effective October 29, 2007
without further notice unless the EPA receives adverse comments by
October 1, 2007.
    If the EPA receives such comments, then EPA will publish a document
withdrawing the final rule and informing the public that the rule will
not take effect. All public comments received will then be addressed in
a subsequent final rule based on the proposed rule. The EPA will not
institute a second comment period. Parties interested in commenting
should do so at this time. If no such comments are received, the public
is advised that this rule will be effective on October 29, 2007 and no
further action will be taken on the proposed rule.

VII. Statutory and Executive Order Reviews

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), this
action is not a ``significant regulatory action'' and therefore is not
subject to review by the Office of Management and Budget. For this
reason, this action is also not subject to Executive Order 13211,
``Actions Concerning Regulations That Significantly Affect Energy
Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001). This action
merely approves State law as meeting Federal requirements and imposes
no additional requirements beyond those imposed by State law.
Accordingly, the Administrator certifies that this rule will not have a
significant economic impact on a substantial number of small entities
under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.). Because
this rule approves pre-existing requirements under state law and does
not impose any additional enforceable duty beyond that required by
state law, it does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4).
    This rule also does not have tribal implications because it will
not have a substantial direct effect on one or more Indian tribes, on
the relationship between the Federal Government and Indian tribes, or
on the distribution of power and responsibilities between the Federal
Government and Indian tribes, as specified by Executive Order 13175 (65
FR 67249, November 9, 2000). This action also does not have Federalism
implications because it does not have substantial direct effects on the
States, on the relationship between the national government and the
States, or on the distribution of power and responsibilities among the
various levels of government, as specified in Executive Order 13132 (64
FR 43255, August 10, 1999), because it merely approves a state rule
implementing a federal standard, and does not alter the relationship or
the distribution of power and responsibilities established in the Clean
Air Act. This rule also is not subject to Executive Order 13045
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997), because it approves a state rule
implementing a Federal standard.
    In reviewing SIP submissions, EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act. In
this context, in the absence of a prior existing requirement for the
State to use voluntary consensus standards (VCS), EPA has no authority
to disapprove a SIP submission for failure to use VCS. It would thus be
inconsistent with applicable law for EPA, when it reviews a SIP
submission, to use VCS in place of a SIP submission that otherwise
satisfies the provisions of the Clean Air Act. Thus, the requirements
of section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (15 U.S.C. 272 note) do not apply. This rule does not
impose an information collection burden under the provisions of the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).
    The Congressional Review Act, 5 U.S.C. section 801 et seq., as
added by the Small Business Regulatory Enforcement Fairness Act of
1996, generally provides that before a rule may take effect, the agency
promulgating the rule must submit a rule report, which includes a copy
of the rule, to each House of the Congress and to the Comptroller
General of the United States. EPA will submit a report containing this
rule and other required information to the U.S. Senate, the U.S. House
of Representatives, and the Comptroller General of the United States
prior to publication of the rule in the Federal Register. A major rule
cannot take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by October 29, 2007. Interested
parties should comment in response to the proposed rule rather than
petition for judicial review, unless the objection arises after the
comment period allowed for in the proposal. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this rule for the purposes of judicial review nor does
it extend the time within which a petition for judicial review may be
filed, and shall not postpone the effectiveness of such rule or action.
This action may not be challenged later in proceedings to enforce its
requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Intergovernmental
relations, Particulate matter, Reporting and recordkeeping
requirements, Sulfur oxides, Volatile organic compounds.

    Dated: August 20, 2007.
Robert W. Varney,
Regional Administrator, EPA New England.

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

PART 52--[AMENDED]

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

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

Subpart H--Connecticut

0
2. Section 52.379 is added to read as follows:

Sec.  52.379  Control strategy: PM2.5.

    Approval--Revision to the State Implementation Plan submitted by
the Connecticut Department of Environmental Protection (DEP) on April
17, 2007. the revision is for the purpose of establishing early fine
particulate (PM2.5) transportation conformity emission
budgets for the Connecticut portion of the New York-Northern New
Jersey-Long Island, NY-NJ-CT PM2.5 nonattainment area. The
April 17, 2007 revision establishes PM2.5 motor vehicle
emission budgets for 2009 of 360 tons per year of direct
PM2.5 emissions and 18,279 tons per year of NOX
emissions to be used in transportation conformity in the Connecticut
portion of the New York-Northern New Jersey-Long Island, NY-NJ-CT
PM2.5 nonattainment area.

 [FR Doc. E7-17004 Filed 8-29-07; 8:45 am]

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[Federal Register: March 9, 2007 (Volume 72, Number 46)]
[Proposed Rules]
[Page 10627-10628]
[DOCID:fr09mr07-21]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 52 and 70

[EPA-R07-OAR-2007-0041; FRL-8284-7]

Approval and Promulgation of Implementation Plans and Operating
Permits Program; State of Missouri

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: EPA proposes to approve a revision to the Missouri State
Implementation Plan (SIP) and Operating Permits Program. EPA proposes
to approve a revision to the Missouri rule entitled ``Submission of
Emission Data, Emission Fees, and Process Information.'' This revision
will ensure consistency between the state and the Federally-approved
rules.

DATES: Comments on this proposed action must be received in writing by
April 9, 2007.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R07-
OAR-2007-0041 by one of the following methods:
    1. http://www.regulations.gov: Follow the on-line instructions for

submitting comments.
    2. E-mail<EMAIL_ADDRESS>    3. Mail: Amy Algoe-Eakin, Environmental Protection Agency, Air
Planning and Development Branch, 901 North 5th Street, Kansas City,
Kansas 66101.
    4. Hand Delivery or Courier. Deliver your comments to: Amy Algoe-
Eakin, Environmental Protection Agency, Air Planning and Development
Branch, 901 North 5th Street, Kansas City, Kansas 66101. Such
deliveries are only accepted during the Regional Office's normal hours
of operation. The Regional Office's official hours of business are
Monday through Friday, 8 a.m. to 4:30 p.m., excluding legal holidays.
    Please see the direct final rule which is located in the Rules
section of this Federal Register for detailed instructions on how to
submit comments.

FOR FURTHER INFORMATION CONTACT: Amy Algoe-Eakin at<PHONE_NUMBER>, or
by e-mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In the final rules section of the Federal
Register, EPA is approving the state's SIP revision and Title V
revision as a direct final rule without prior proposal because the
Agency views this as a noncontroversial revision amendment and
anticipates no relevant adverse comments to this action. A detailed
rationale for the approval is set forth in the direct final rule. If no
relevant adverse comments are received in response to this action, no
further activity is contemplated in relation to this action. If EPA
receives relevant adverse comments, the direct final rule will be
withdrawn and all public comments received will be addressed in a
subsequent final rule based on this proposed action. EPA will not
institute a second comment period on this action. Any parties
interested in commenting on this action should do so at this time.
Please note that if EPA receives adverse comment on part of this rule
and if that part can be severed from the remainder of the rule, EPA may
adopt as final those parts of the rule that are not the subject of an
adverse comment. For additional information, see the direct final rule
which is located in the rules section of this Federal Register.

    Dated: February 27, 2007.
John B. Askew,
Regional Administrator, Region 7.
 [FR Doc. E7-4175 Filed 3-8-07; 8:45 am]

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[Federal Register: December 4, 2009 (Volume 74, Number 232)]
[Rules and Regulations]
[Page 63595-63598]
[DOCID:fr04de09-19]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2009-1106; Directorate Identifier 2009-NM-171-AD;
Amendment 39-16122; AD 2008-09-24 R1]
RIN 2120-AA64

Airworthiness Directives; Bombardier Model DHC-8-400, DHC-8-401,
and DHC-8-402 Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule; request for comments.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for the
products listed above that would revise an existing AD. This AD results
from mandatory continuing airworthiness information (MCAI) originated
by an aviation authority of another country to identify and correct an
unsafe condition on an aviation product. The MCAI describes the unsafe
condition as:

    Bombardier Aerospace has completed a system safety review of the
aircraft fuel system against fuel tank safety standards introduced
in Chapter 525 of the Airworthiness Manual through Notice of
Proposed Amendment (NPA) 2002-043. The identified non-compliances
were then assessed using Transport Canada Policy Letter No. 525-001,
to determine if mandatory corrective action is required.
    The assessment showed that it is necessary to introduce Critical
Design Configuration Control Limitations (CDCCL), in order to
preserve critical fuel tank system ignition source prevention
features during configuration changes such as modifications and
repairs, or during maintenance actions. Failure to preserve critical
fuel tank system ignition source prevention features could result in
a fuel tank explosion. * * *

    This AD requires actions that are intended to address the unsafe
condition described in the MCAI.

DATES: This AD becomes effective December 21, 2009.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in the AD as of December 21,
2009.
    On June 6, 2008 (73 FR 24143, May 2, 2008), the Director of the
Federal Register approved the incorporation by reference of certain
other publications listed in the AD.
    We must receive comments on this AD by January 19, 2010.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://
www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey, Avenue, SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-40, 1200 New
Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    For service information identified in this AD, contact Bombardier,
Inc., 400 C[ocirc]te-Vertu Road West, Dorval, Qu[eacute]bec H4S 1Y9,
Canada; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>; e-mail
<EMAIL_ADDRESS>Internet http://www.bombardier.com.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://
www.regulations.gov; or in person at the Docket Operations office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this AD, the regulatory evaluation,
any comments received, and other information. The street address for
the Docket Operations office (telephone<PHONE_NUMBER>) is in the
ADDRESSES section. Comments will be available in the AD docket shortly
after receipt.

FOR FURTHER INFORMATION CONTACT: Richard Fiesel, Aerospace Engineer,
Airframe and Mechanical Systems Branch, ANE-171, FAA, New York Aircraft
Certification Office, 1600 Stewart Avenue, Suite 410, Westbury, New
York 11590; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    On April 24, 2008, we issued AD 2008-09-24, Amendment 39-15505 (73
FR 24143, May 2, 2008). That AD applied to all Bombardier Model DHC-8-
400, DHC-8-401, and DHC-8-402 airplanes. That AD required revising the
Airworthiness Limitations Section (ALS) of the Instructions for
Continued Airworthiness to incorporate the CDCCLs specified in Dash 8
Q400 (Bombardier) Temporary Revisions (TRs) ALI-55, dated April 19,
2006; and ALI-56, dated April 19, 2006; to Part 2, ``Airworthiness
Limitations Items,'' of the Bombardier Dash 8 Q400 Maintenance
Requirements Manual (MRM) PSM 1-84-7.
    Critical design configuration control limitations (CDCCLs) are
limitation requirements to preserve a critical ignition source
prevention feature of the fuel tank system design that is necessary to
prevent the occurrence of an unsafe condition. The purpose of a CDCCL
is to provide instruction to retain the critical ignition source
prevention feature during configuration change that may be caused by
alterations, repairs, or maintenance actions. A CDCCL is not a periodic
inspection.
    Since we issued that AD, we have determined that it is necessary to
clarify the AD's intended effect on spare and on-airplane fuel tank
system components, regarding the use of maintenance manuals and
instructions for continued airworthiness.
    Section 91.403(c) of the Federal Aviation Regulations (14 CFR
91.403(c)) specifies the following:

    No person may operate an aircraft for which a manufacturer's
maintenance manual or instructions for continued airworthiness has
been issued that contains an airworthiness limitation section unless
the mandatory * * * procedures * * * have been complied with.

    Some operators have questioned whether existing components affected
by the new CDCCLs must be reworked. We did not intend for the AD to
retroactively require rework of components that had been maintained
using acceptable methods before the effective date of the AD. Owners
and operators of the affected airplanes therefore are not required to
rework affected components identified as airworthy or installed on the
affected airplanes before the required revisions of the ALS. But once
the CDCCLs are incorporated into the ALS, future maintenance actions on
components must be done in accordance with those CDCCLs.

Relevant Service Information

    AD 2008-09-24 cites Dash 8 Q400 (Bombardier) Temporary Revision
(TR) ALI-55, dated April 19, 2006; and TR ALI-56, dated April 19, 2006;
to Part 2, ``Airworthiness Limitations Items,'' of the Bombardier Dash
8 Q400 Maintenance Requirements Manual PSM 1-84-7. Since we issued that
AD, Bombardier has revised the referenced service information. We have
reviewed Dash 8 Q400 (Bombardier) TR ALI-76, dated January 24, 2008, to
Part 2, ``Airworthiness Limitations Items,'' of the Bombardier Dash 8
Q400 MRM PSM

1-84-7. The revised TR supersedes and cancels TR ALI-56 and updates
applicability information, but adds no new procedures.

FAA's Determination

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. This new
AD retains the requirements of the existing AD, and adds a new note to
clarify the intended effect of the AD on spare and on-airplane fuel
tank system components.

Explanation of Additional Change to AD

    AD 2008-09-24 allowed the use of alternative CDCCLs if they are
part of a later revision of Part 2, Revision 4, dated October 30, 2003,
of the Bombardier Dash 8 Q400 MRM PSM 1-84-7, Revision 4. That
provision has been removed from this AD. Allowing the use of ``a later
revision'' of a specific service document violates Office of the
Federal Register regulations for approving materials that are
incorporated by reference. Affected operators, however, may request
approval to use an alternative CDCCL that is part of a later revision
of the referenced service document as an alternative method of
compliance, under the provisions of paragraph (g)(1) of this AD.

Differences Between the AD and the MCAI or Service Information

    We have reviewed the MCAI and related service information and, in
general, agree with their substance. But we might have found it
necessary to use different words from those in the MCAI to ensure the
AD is clear for U.S. operators and is enforceable. In making these
changes, we do not intend to differ substantively from the information
provided in the MCAI and related service information.
    We might also have required different actions in this AD from those
in the MCAI in order to follow FAA policies. Any such differences are
highlighted in a NOTE within the AD.

Costs of Compliance

    This revision imposes no additional economic burden. The current
costs for this AD are repeated for the convenience of affected
operators, as follows:
    We estimate that this AD will affect about 45 products of U.S.
registry. We also estimate that it will take about 1 work-hour per
product to comply with the basic requirements of this AD. The average
labor rate is $80 per work-hour. Based on these figures, we estimate
the cost of this AD to the U.S. operators to be $3,600, or $80 per
product.

FAA's Justification and Determination of the Effective Date

    This revision merely clarifies the intended effect on spare and on-
airplane fuel tank system components, and makes no substantive change
to the AD's requirements. For this reason, it is found that notice and
opportunity for prior public comment for this action are unnecessary,
and good cause exists for making this amendment effective in less than
30 days.

Comments Invited

    This AD is a final rule that involves requirements affecting flight
safety, and we did not precede it by notice and opportunity for public
comment. We invite you to send any written relevant data, views, or
arguments about this AD. Send your comments to an address listed under
the ADDRESSES section. Include ``Docket No. FAA-2009-1106; Directorate
Identifier 2009-NM-171-AD'' at the beginning of your comments. We
specifically invite comments on the overall regulatory, economic,
environmental, and energy aspects of this AD. We will consider all
comments received by the closing date and may amend this AD because of
those comments.
    We will post all comments we receive, without change, to http://
www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this AD.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this AD will not have federalism implications
under Executive Order 13132. This AD will not have a substantial direct
effect on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.
    For the reasons discussed above, I certify this AD:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979); and
    3. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act. We prepared a regulatory evaluation
of the estimated costs to comply with this AD and placed it in the AD
docket.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

0
Accordingly, under the authority delegated to me by the Administrator,
the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by removing amendment 39-15505 (73 FR
24143, May 2, 2008) and adding the following new AD:

2008-09-24 R1 BOMBARDIER, INC. (Formerly de Havilland, Inc.):
Amendment 39-16122. Docket No. FAA-2009-1106; Directorate Identifier
2009-NM-171-AD.

Effective Date

    (a) This airworthiness directive (AD) becomes effective December
21, 2009.

Affected ADs

    (b) This AD revises AD 2008-09-24, Amendment 39-15505.

Applicability

    (c) This AD applies to all Bombardier Model DHC-8-400, DHC-8-
401, and DHC-8-402 airplanes, certificated in any category, all
serial numbers.

Subject

    (d) Air Transport Association (ATA) of America Code 28: Fuel.

Reason

    (e) The mandatory continuing airworthiness information (MCAI)
states:

    ``Bombardier Aerospace has completed a system safety review of
the aircraft fuel system against fuel tank safety standards
introduced in Chapter 525 of the Airworthiness Manual through Notice
of Proposed Amendment (NPA) 2002-043. The identified non-compliances
were then assessed using Transport Canada Policy Letter No. 525-001,
to determine if mandatory corrective action is required.''
    ``The assessment showed that it is necessary to introduce
Critical Design Configuration Control Limitations (CDCCL), in order
to preserve critical fuel tank system ignition source prevention
features during configuration changes such as modifications and
repairs, or during maintenance actions. Failure to preserve critical
fuel tank system ignition source prevention features could result in
a fuel tank explosion. Revisions have been made to Part 2
``Airworthiness Limitations Items'' of the Maintenance Requirements
Manual of the affected models to introduce the required CDCCL.''

    The corrective action is revising the Airworthiness Limitations
Section (ALS) of the Instructions for Continued Airworthiness to
include the CDCCL data.

Restatement of Requirements of AD 2008-09-24, With Updated Service
Information

Actions and Compliance

    (f) Unless already done, do the following actions.
    (1) For all airplanes: Within 60 days after June 6, 2008 (the
effective date of AD 2008-09-24), revise the ALS of the Instructions
for Continued Airworthiness to incorporate the CDCCLs specified in
Dash 8 Q400 (Bombardier) Temporary Revisions (TRs) ALI-55, dated
April 19, 2006; ALI-56, dated April 19, 2006; and TR ALI-76, dated
January 24, 2008; to Part 2, ``Airworthiness Limitations Items,'' of
the Bombardier Dash 8 Q400 Maintenance Requirements Manual (MRM) PSM
1-84-7.

    Note 1:  The actions required by paragraph (f)(1) of this AD may
be done by inserting a copy of the applicable TRs into the
maintenance requirements manual. When the TRs have been included in
the general revision of the maintenance program, the general
revision may be inserted into the maintenance requirements manual,
provided the relevant information in the general revision is
identical to that in the applicable TRs, and the TRs may be removed.

    (2) After accomplishing the actions specified in paragraph
(f)(1) of this AD, no alternative CDCCLs may be used unless the
CDCCLs are approved as an alternative method of compliance (AMOC) in
accordance with the procedures specified in paragraph (g)(1) of this
AD.

New Information

Explanation of CDCCL Requirements

    Note 2:  Notwithstanding any other maintenance or operational
requirements, components that have been identified as airworthy or
installed on the affected airplanes before the revision of the ALS,
as required by paragraph (f)(1) of this AD, do not need to be
reworked in accordance with the CDCCLs. However, once the ALS has
been revised, future maintenance actions on these components must be
done in accordance with the CDCCLs.

FAA AD Differences

    Note 3: This AD differs from the MCAI and/or service information
as follows: No differences.

Other FAA AD Provisions

    (g) The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager, New
York Aircraft Certification Office, ANE-170, FAA, has the authority
to approve AMOCs for this AD, if requested using the procedures
found in 14 CFR 39.19. Send information to ATTN: Program Manager,
Continuing Operational Safety, FAA, New York ACO, 1600 Stewart
Avenue, Suite 410, Westbury, New York, 11590; telephone 516-228-
7300; fax<PHONE_NUMBER>. Before using any approved AMOC on any
airplane to which the AMOC applies, notify your principal
maintenance inspector (PMI) or principal avionics inspector (PAI),
as appropriate, or lacking a principal inspector, your local Flight
Standards District Office. The AMOC approval letter must
specifically reference this AD.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to ensure the product
is airworthy before it is returned to service.
    (3) Reporting Requirements: For any reporting requirement in
this AD, under the provisions of the Paperwork Reduction Act (44
U.S.C. 3501 et seq.), the Office of Management and Budget (OMB) has
approved the information collection requirements and has assigned
OMB Control Number 2120-0056.

Related Information

    (h) Refer to MCAI Canadian Airworthiness Directive CF-2008-06,
dated January 15, 2008, and the service information specified in
Table 1 of this AD, for related information.

                  Table 1--Related Service Information
------------------------------------------------------------------------
     Dash 8 Q400 (Bombardier) TR--                   Dated--
------------------------------------------------------------------------
ALI-55................................  April 19, 2006.
ALI-56................................  April 19, 2006.
ALI-76................................  January 24, 2008.
------------------------------------------------------------------------

Material Incorporated by Reference

    (i) You must use the service information specified in Table 2 of
this AD, as applicable, to do the actions required by this AD,
unless the AD specifies otherwise.

         Table 2--Service Information Incorporated by Reference
------------------------------------------------------------------------
        Dash 8 Q400 (Bombardier) TR--                   Dated--
------------------------------------------------------------------------
ALI-55 to Part 2, ``Airworthiness             April 19, 2006.
 Limitations Items,'' of the Bombardier Dash
 8 Q400 Maintenance Requirements Manual
 (MRM) PSM 1-84-7.
ALI-56 to Part 2, ``Airworthiness             April 19, 2006.
 Limitations Items,'' of the Bombardier Dash
 8 Q400 Maintenance Requirements Manual
 (MRM) PSM 1-84-7.
ALI-76 to Part 2, ``Airworthiness             January 24, 2008.
 Limitations Items,'' of the Bombardier Dash
 8 Q400 Maintenance Requirements Manual
 (MRM) PSM 1-84-7.
------------------------------------------------------------------------

    (1) The Director of the Federal Register approved the
incorporation by reference of Dash 8 Q400 (Bombardier) TR ALI-76,
dated January 24, 2008, under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) The Director of the Federal Register previously approved the
incorporation by reference of Dash 8 Q400 (Bombardier) TR ALI-55,
dated April 19, 2006; and Dash 8 Q400 (Bombardier) TR ALI-56, dated
April 19, 2006; on June 6, 2008 (73 FR 24143, May 2, 2008).
    (3) For service information identified in this AD, contact
Bombardier, Inc., 400 C[ocirc]te-Vertu Road West, Dorval,
Qu[eacute]bec H4S 1Y9, Canada; telephone<PHONE_NUMBER>; fax 514-855-
7401; e-mail<EMAIL_ADDRESS>Internet http://
www.bombardier.com.
    (4) You may review copies of the service information at the FAA,
Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton,
Washington. For information on the availability of this material at
the FAA, call<PHONE_NUMBER> or<PHONE_NUMBER>.
    (5) You may also review copies of the service information that
is incorporated by reference at the National Archives and Records
Administration (NARA). For information on the availability of this
material at NARA, call<PHONE_NUMBER>, or go to: http://
www.archives.gov/federal_register/

code_of_federal_regulations/ibr_locations.html.

    Issued in Renton, Washington, on November 19, 2009.
Stephen P. Boyd,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. E9-28763 Filed 12-3-09; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register Volume 84, Number 241 (Monday, December 16, 2019)]
[Notices]
[Pages 68460-68462]
[FR Doc No: 2019-26994]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0529]

Qualification Process for Drug Development Tools; Draft Guidance
for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) Center for
Drug Evaluation and Research (CDER) and Center for Biologics Evaluation
and Research (CBER) are announcing the availability of a draft guidance
for industry and FDA staff entitled ``Qualification Process for Drug
Development Tools.'' Under the 21st Century Cures Act (Cures Act),
enacted on December 13, 2016, a new section was added to the Federal
Food, Drug, and Cosmetic Act (FD&C Act), which defined a three-stage
qualification process for drug development tools (DDTs). This guidance
meets the Cures Act's mandate to issue guidance on this qualification
process and related Prescription Drug User Fee Act (PDUFA) VI
commitments. It elaborates on the new qualification process and
transparency requirements and discusses the taxonomy for biomarkers and
other DDTs, and the draft guidance of the same name issued January 7,
2014, is withdrawn.

DATES: Submit either electronic or written comments on the draft
guidance by February 14, 2020 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-2010-D-0529 for ``Qualification Process for Drug Development
Tools.'' 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.'' CDER and CBER will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research (CDER), Food and Drug Administration, 10001 New Hampshire
Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002; or
the Office of Communication, Outreach, and Development, Center for
Biologics Evaluation and Research (CBER), Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-
0002. Send one self-addressed adhesive label to assist that office in
processing your requests. See the SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Chris Leptak, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6461, Silver Spring, MD 20993-0002, 301-
796-0017; or Stephen Ripley, Center for Biologics Evaluation and
Research, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring,
MD 20993-0002;<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    CDER and CBER are announcing the availability of a draft guidance
for industry and FDA staff entitled ``Qualification Process for Drug
Development Tools.'' Passed into law in December 2016, the Cures Act
codified, in new section 507 of the FD&C Act (21 U.S.C. 357), a new
statutory process for DDT qualification and added transparency
provisions for information related to qualification submissions through
which there is enhanced ability to share knowledge and engage with
biomedical research consortia. In addition, Congress directed CDER and
CBER to establish a taxonomy for the classification of biomarkers (and
related scientific concepts) for use in drug (including biological
product) development. CDER and CBER convened a public meeting on
December 11, 2018, both to solicit public input about implementing the
new qualification process under section 507 and about the Biomarkers,
EndpointS, and other Tools (BEST) glossary as the taxonomy for
classifying types of DDTs, including biomarkers. CDER and CBER are
issuing this draft guidance to implement the 507 qualification process,
meeting Cures Act mandates and related PDUFA VI commitments.
    DDTs are methods, materials, or measures that can aid drug
development and regulatory review. Qualification means that a DDT and
its proposed context of use can be relied upon to have a specific
interpretation and application in drug development and regulatory
review. Qualified DDTs can accelerate the integration of innovation,
clinical knowledge, and scientific advances, thereby expediting drug
development and aiding the regulatory review of applications.
    Although the DDT qualification process is voluntary, requestors who
seek qualification under section 507 must follow the three-stage
process described in the Cures Act. This consists of the following
stages: The Letter of Intent, the Qualification Plan, and the Full
Qualification Package. These stages are discussed in detail in section
III of the draft guidance.
    The Cures Act includes transparency provisions that require CDER
and CBER to make information with respect to qualification submissions
publicly available. A description of information that is made public on
the Agency's website is provided in section II of the draft guidance.
    CDER and CBER convened a public meeting on December 11, 2018, made
available a discussion guide on the implementation of the new section
507 qualification process, and identified the taxonomy (the BEST
glossary) for classifying types of DDTs. CDER and CBER have considered
public comments made during the meeting and submitted to the docket in
developing this draft guidance. This guidance meets the Cures Act's
mandate to issue guidance on the section 507 qualification process and
related PDUFA VI commitments. This guidance does not address
evidentiary standards or performance criteria for purposes of DDT
qualification. It also does not address the qualification of medical
device development tools or the programs under the Center for Devices
and

Radiological Health oversight, which are not addressed in section 507.
    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
``Qualification Process for Drug Development Tools.'' It does not
establish any rights for any person and is not binding on FDA or the
public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    This draft guidance contains information collection that is 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 information
collection has been approved under OMB control numbers 0910-0001 and
0910-0014.

III. Electronic Access

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

    Dated: December 11, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-26994 Filed 12-13-19; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 84, Number 173 (Friday, September 6, 2019)]
[Notices]
[Pages 47036-47038]
[FR Doc No: 2019-19264]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2010-0203; FMCSA-2011-0389; FMCSA-2012-0094; FMCSA-
2012-0294; FMCSA-2014-0381; FMCSA-2014-0382; FMCSA-2015-0116; FMCSA-
2015-0117; FMCSA-2016-0008; FMCSA-2017-0178]

Qualification of Drivers; Exemption Applications; Epilepsy and
Seizure Disorders

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

ACTION: Notice of renewal of exemptions; request for comments.

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

SUMMARY: FMCSA announces its decision to renew exemptions for 14
individuals from the requirement in the Federal Motor Carrier Safety
Regulations (FMCSRs) that interstate commercial motor vehicle (CMV)
drivers have ``no established medical history or clinical diagnosis of
epilepsy or any other condition which is likely to cause loss of
consciousness or any loss of ability to control a CMV.'' The exemptions
enable these individuals who have had one or more seizures and are
taking anti-seizure medication to continue to operate CMVs in
interstate commerce.

DATES: Each group of renewed exemptions were applicable on the dates
stated in the discussions below and will expire on the dates stated in
the discussions below. Comments must be received on or before October
7, 2019.

ADDRESSES: You may submit comments identified by the Federal Docket
Management System (FDMS) Docket No. FMCSA-2010-0203; FMCSA-2011-0389;
FMCSA-2012-0094; FMCSA-2012-0294; FMCSA-2014-0381; FMCSA-2014-0382;
FMCSA-2015-0116; FMCSA-2015-0117; FMCSA-2016-0008; FMCSA-2017-0178
using any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the online instructions for submitting
comments.
     Mail: Docket Management Facility; U.S. Department of
Transportation, 1200 New Jersey Avenue SE, West Building Ground Floor,
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery: West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue SE, Washington, DC, between 9 a.m. and 5 p.m.,
ET, Monday through Friday, except Federal Holidays.
     Fax:<PHONE_NUMBER>.
    To avoid duplication, please use only one of these four methods.
See the ``Public Participation'' portion of the SUPPLEMENTARY
INFORMATION section for instructions on submitting comments.

FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, Chief,
Medical Programs Division,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA,
Department of Transportation, 1200 New Jersey Avenue SE, Room W64-224,
Washington, DC 20590-0001. Office hours are from 8:30 a.m. to 5 p.m.,
ET, Monday through Friday, except Federal holidays. If you have
questions regarding viewing or submitting material to the docket,
contact Docket Services,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Public Participation

A. Submitting Comments

    If you submit a comment, please include the docket number for this
notice (Docket No. FMCSA-2010-0203; FMCSA-2011-0389; FMCSA-2012-0094;
FMCSA-2012-0294; FMCSA-

2014-0381; FMCSA-2014-0382; FMCSA-2015-0116; FMCSA-2015-0117; FMCSA-
2016-0008; FMCSA-2017-0178), indicate the specific section of this
document to which each comment applies, and provide a reason for each
suggestion or recommendation. You may submit your comments and material
online or by fax, mail, or hand delivery, but please use only one of
these means. FMCSA recommends that you include your name and a mailing
address, an email address, or a phone number in the body of your
document so that FMCSA can contact you if there are questions regarding
your submission.
    To submit your comment online, go to http://www.regulations.gov,
put the docket number, FMCSA-2010-0203; FMCSA-2011-0389; FMCSA-2012-
0094; FMCSA-2012-0294; FMCSA-2014-0381; FMCSA-2014-0382; FMCSA-2015-
0116; FMCSA-2015-0117; FMCSA-2016-0008; FMCSA-2017-0178, in the keyword
box, and click ``Search.'' When the new screen appears, click on the
``Comment Now!'' button and type your comment into the text box on the
following screen. Choose whether you are submitting your comment as an
individual or on behalf of a third party and then submit.
    If you submit your comments by mail or hand delivery, submit them
in an unbound format, no larger than 8\1/2\ by 11 inches, suitable for
copying and electronic filing. If you submit comments by mail and would
like to know that they reached the facility, please enclose a stamped,
self-addressed postcard or envelope.
    FMCSA will consider all comments and material received during the
comment period.

B. Viewing Documents and Comments

    To view comments, as well as any documents mentioned in this notice
as being available in the docket, go to http://www.regulations.gov.
Insert the docket number, FMCSA-2010-0203; FMCSA-2011-0389; FMCSA-2012-
0094; FMCSA-2012-0294; FMCSA-2014-0381; FMCSA-2014-0382; FMCSA-2015-
0116; FMCSA-2015-0117; FMCSA-2016-0008; FMCSA-2017-0178, in the keyword
box, and click ``Search.'' Next, click the ``Open Docket Folder''
button and choose the document to review. If you do not have access to
the internet, you may view the docket online by visiting the Docket
Management Facility in Room W12-140 on the ground floor of the DOT West
Building, 1200 New Jersey Avenue SE, Washington, DC 20590, between 9
a.m. and 5 p.m., ET, Monday through Friday, except Federal holidays.

C. Privacy Act

    In accordance with 5 U.S.C. 553(c), DOT solicits comments from the
public to better inform its rulemaking process. DOT posts these
comments, without edit, including any personal information the
commenter provides, to www.regulations.gov, as described in the system
of records notice (DOT/ALL-14 FDMS), which can be reviewed at
www.dot.gov/privacy.

II. Background

    Under 49 U.S.C. 31136(e) and 31315(b), FMCSA may grant an exemption
from the FMCSRs for no longer than a 5-year period if it finds such
exemption would likely achieve a level of safety that is equivalent to,
or greater than, the level that would be achieved absent such
exemption. The statute also allows the Agency to renew exemptions at
the end of the 5-year period. FMCSA grants medical exemptions from the
FMCSRs for a 2-year period to align with the maximum duration of a
driver's medical certification.
    The physical qualification standard for drivers regarding epilepsy
found in 49 CFR 391.41(b)(8) states that a person is physically
qualified to drive a CMV if that person has no established medical
history or clinical diagnosis of epilepsy or any other condition which
is likely to cause the loss of consciousness or any loss of ability to
control a CMV.
    In addition to the regulations, FMCSA has published advisory
criteria\1\ to assist medical examiners (MEs) in determining whether
drivers with certain medical conditions are qualified to operate a CMV
in interstate commerce.
---------------------------------------------------------------------------

    \1\ These criteria may be found in APPENDIX A TO PART 391--
MEDICAL ADVISORY CRITERIA, section H. Epilepsy: Sec.  391.41(b)(8),
paragraphs 3, 4, and 5, which is available on the internet at
https://www.gpo.gov/fdsys/pkg/CFR-2015-title49-vol5/pdf/CFR-2015-title49-vol5-part391-appA.pdf.
---------------------------------------------------------------------------

    The 14 individuals listed in this notice have requested renewal of
their exemptions from the epilepsy and seizure disorders prohibition in
Sec.  391.41(b)(8), in accordance with FMCSA procedures. Accordingly,
FMCSA has evaluated these applications for renewal on their merits and
decided to extend each exemption for a renewable 2-year period.

III. Request for Comments

    Interested parties or organizations possessing information that
would otherwise show that any, or all, of these drivers are not
currently achieving the statutory level of safety should immediately
notify FMCSA. The Agency will evaluate any adverse evidence submitted
and, if safety is being compromised or if continuation of the exemption
would not be consistent with the goals and objectives of 49 U.S.C.
31136(e) and 31315(b), FMCSA will take immediate steps to revoke the
exemption of a driver.

IV. Basis for Renewing Exemptions

    In accordance with 49 U.S.C. 31136(e) and 31315(b), each of the 14
applicants has satisfied the renewal conditions for obtaining an
exemption from the epilepsy and seizure disorders prohibition. The 14
drivers in this notice remain in good standing with the Agency, have
maintained their medical monitoring and have not exhibited any medical
issues that would compromise their ability to safely operate a CMV
during the previous 2-year exemption period. In addition, for
Commercial Driver's License (CDL) holders, the Commercial Driver's
License Information System and the Motor Carrier Management Information
System are searched for crash and violation data. For non-CDL holders,
the Agency reviews the driving records from the State Driver's
Licensing Agency. These factors provide an adequate basis for
predicting each driver's ability to continue to safely operate a CMV in
interstate commerce. Therefore, FMCSA concludes that extending the
exemption for each renewal applicant for a period of 2 years is likely
to achieve a level of safety equal to that existing without the
exemption.
    In accordance with 49 U.S.C. 31136(e) and 31315(b), the following
groups of drivers received renewed exemptions in the month of August
and are discussed below.
    As of August 1, 2019, and in accordance with 49 U.S.C. 31136(e) and
31315(b), the following three individuals have satisfied the renewal
conditions for obtaining an exemption from the epilepsy and seizure
disorders prohibition in the FMCSRs for interstate CMV drivers: Donnie
Kuck (MT); Tye Moore (IN); and Rickie Rineer (PA).
    The drivers were included in docket numbers FMCSA-2017-0178 and
FMCSA-2016-0008. Their exemptions are applicable as of August 1, 2019,
and will expire on August 1, 2021.
    As of August 13, 2019, and in accordance with 49 U.S.C. 31136(e)
and 31315(b), the following 11 individuals have satisfied the renewal
conditions for obtaining an exemption from the epilepsy and seizure
disorders prohibition in the FMCSRs for interstate CMV drivers:

Eric Barnwell (MI)
John Boerth (WI)

Don Darbyshire (IA)
Todd Davis (WI)
Daniel Dellaserra (CA)
Charles Gray (OK)
Eric Hilmer (WI)
David Kietzman (WI)
Dennis Klamm (MN)
William Rainer, III (TX)
Brian Wiggins (ID)

    The drivers were included in docket number FMCSA-2010-0203; FMCSA-
2011-0389; FMCSA-2012-0094; FMCSA-2012-0294; FMCSA-2014-0381; FMCSA-
2014-0382; FMCSA-2015-0116; FMCSA-2015-0117. Their exemptions are
applicable as of August 13, 2019, and will expire on August 13, 2021.

V. Conditions and Requirements

    The exemptions are extended subject to the following conditions:
(1) Each driver must remain seizure-free and maintain a stable
treatment during the 2-year exemption period; (2) each driver must
submit annual reports from their treating physicians attesting to the
stability of treatment and that the driver has remained seizure-free;
(3) each driver must undergo an annual medical examination by a
certified ME, as defined by Sec.  390.5; and (4) each driver must
provide a copy of the annual medical certification to the employer for
retention in the driver's qualification file, or keep a copy of his/her
driver's qualification file if he/she is self-employed. The driver must
also have a copy of the exemption when driving, for presentation to a
duly authorized Federal, State, or local enforcement official. The
exemption will be rescinded if: (1) The person fails to comply with the
terms and conditions of the exemption; (2) the exemption has resulted
in a lower level of safety than was maintained before it was granted;
or (3) continuation of the exemption would not be consistent with the
goals and objectives of 49 U.S.C. 31136(e) and 31315(b).

VI. Preemption

    During the period the exemption is in effect, no State shall
enforce any law or regulation that conflicts with this exemption with
respect to a person operating under the exemption.

VII. Conclusion

    Based on its evaluation of the 14 exemption applications, FMCSA
renews the exemptions of the aforementioned drivers from the epilepsy
and seizure disorders prohibition in Sec.  391.41(b)(8). In accordance
with 49 U.S.C. 31136(e) and 31315(b), each exemption will be valid for
2 years unless revoked earlier by FMCSA.

    Issued on: August 29, 2019.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2019-19264 Filed 9-5-19; 8:45 am]
 BILLING CODE 4910-EX-P


P-20-0012 Sanitized Support Documents Index:
 P-20-0012 Sanitized Determination Document (linked)
 P-20-0012 Sanitized CHEM Report (attached)
 P-20-0012 Sanitized ECO Report (attached)
 P-20-0012 Sanitized ENG Report (attached)
 P-20-0012 Sanitized EXP Report (attached)
 P-20-0012 Sanitized Fate Report (attached)
 P-20-0012 Sanitized HLTH Report_POST-FOCUS FINAL (attached)