[Federal Register Volume 80, Number 73 (Thursday, April 16, 2015)]
[Rules and Regulations]
[Pages 20441-20444]
[FR Doc No: 2015-08666]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 52

[EPA-R04-OAR-2014-0220; FRL-9926-34-Region 4]

Air Quality Implementation Plan; Florida; Attainment Plan for the
Hillsborough Area for the 2008 Lead National Ambient Air Quality
Standards

AGENCY: Environmental Protection Agency.

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is taking final
action to approve revisions to the state implementation plan (SIP),
submitted by the State of Florida through the Florida Department of
Environmental Protection (FL DEP), on June 29, 2012, as amended on June
27, 2013, for the purpose of providing for attainment of the 2008 Lead
(Pb) National Ambient Air Quality Standards (NAAQS) in the Hillsborough
2008 Lead nonattainment area (hereafter referred to as the
``Hillsborough Area'' or ``Area''). The Hillsborough Area is comprised
of a portion of Hillsborough County in Florida surrounding EnviroFocus
Technologies, LLC (hereafter referred to as ``EnviroFocus''). The
attainment plan

includes the base year emissions inventory, an analysis of reasonably
available control technology (RACT) and reasonably available control
measures (RACM), reasonable further progress (RFP) plan, modeling
demonstration of lead attainment, and contingency measures for the
Hillsborough Area. This action is being taken in accordance with the
Clean Air Act (CAA or Act).

DATES: This rule will be effective May 18, 2015.

ADDRESSES: EPA has established a docket for this action under Docket
Identification No. EPA-R04-OAR-2014-0220. All documents in the docket
are listed on the www.regulations.gov Web site. Although listed in the
index, some information is not publicly available, i.e., Confidential
Business Information or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either electronically through www.regulations.gov or in hard
copy at the Air Regulatory Management Section (formerly the Regulatory
Development Section), Air Planning and Implementation Branch, Air
(formerly the Air Planning Branch), Pesticides and Toxics Management
Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth
Street SW., Atlanta, Georgia 30303-8960. EPA requests that if at all
possible, you contact the person listed in the FOR FURTHER INFORMATION
CONTACT section to schedule your inspection. The Regional Office's
official hours of business are Monday through Friday, 8:30 a.m. to 4:30
p.m., excluding Federal holidays.

FOR FURTHER INFORMATION CONTACT: Zuri Farngalo, Air Regulatory
Management Section, Air Planning and Implementation Branch, Air,
Pesticides and Toxics Management Division, U.S. Environmental
Protection Agency, Region 4, 61 Forsyth Street SW., Atlanta, Georgia
30303-8960. Zuri Farngalo may be reached by phone at<PHONE_NUMBER> or
via electronic mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. What is the background for this action?

    On November 12, 2008 (73 FR 66964), EPA revised the Lead NAAQS,
lowering the level from 1.5 micrograms per cubic meter ([micro]g/m\3\)
to 0.15 [micro]g/m\3\ calculated over a three-month rolling average.
EPA established the NAAQS based on significant evidence and numerous
health studies demonstrating that serious health effects are associated
with exposures to lead emissions.
    Following promulgation of a new or revised NAAQS, EPA is required
by the CAA to designate areas throughout the United States as attaining
or not attaining the NAAQS; this designation process is described in
section 107(d)(1) of the CAA. On November 22, 2010 (75 FR 71033), EPA
promulgated initial air quality designations for the 2008 Lead NAAQS,
which became effective on December 31, 2010, based on air quality
monitoring data for calendar years 2007-2009, where there was
sufficient data to support a nonattainment designation. Designations
for all remaining areas were completed on November 22, 2011 (76 FR
72097), which became effective on December 31, 2011, based on air
quality monitoring data for calendar years 2008-2010. Effective
December 31, 2010, the Hillsborough Area was designated as
nonattainment for the 2008 Lead NAAQS. This designation triggered a
requirement for Florida to submit a SIP revision with a plan for how
the Area would attain the 2008 Lead NAAQS, as expeditiously as
practicable, but no later than December 31, 2015.
    FL DEP submitted its 2008 Lead NAAQS attainment SIP for the
Hillsborough Area on June 29, 2012, as amended on June 27, 2013, which
included the base year emissions inventory and the attainment
demonstration. EPA proposed to approve the Hillsborough Area attainment
SIP for the 2008 Lead NAAQS on February 5, 2015. EPA's analysis of the
submitted attainment demonstration included a review of the pollutant
addressed, emissions inventory requirements, modeling, RACT and RACM
requirements, RFP plan, and contingency measures for the Hillsborough
Area. Refer to EPA's February 5, 2015, proposed rulemaking for a
detailed rationale on EPA's analysis of the Hillsborough area
attainment demonstration. See 80 FR 6485.

II. What is the action EPA is taking?

    EPA is taking final action to approve Florida's SIP submittal for
the Hillsborough Area, as submitted through FL DEP to EPA on June 29,
2012, as amended on June 27, 2013, for the purpose of demonstrating
attainment of the 2008 Lead NAAQS. Florida's lead attainment plan for
the Hillsborough Area includes a base year emissions inventory, a
modeling demonstration of lead attainment, an analysis of RACM/RACT, a
RFP plan, and contingency measures.
    EPA has determined that Florida's attainment plan for the 2008 Lead
NAAQS for the Hillsborough Area meets the applicable requirements of
the CAA. Thus, EPA is taking final action to approve Florida's
attainment plan for the Hillsborough Area. EPA's analysis for this
final action is discussed in Section IV of EPA's February 5, 2015,
proposed rulemaking. See 80 FR 6485.

III. Why is EPA taking this action?

    EPA has determined that all the criteria for Florida's lead
attainment plan for the Hillsborough Area have been met. EPA has
determined that Florida's June 29, 2012, SIP submission, as amended on
June 27, 2013, meets the applicable requirements of the CAA.
Specifically, EPA is taking final action to approve Florida's June 29,
2012, SIP submission (as amended on June 27, 2013), which includes the
attainment demonstration, base year emissions inventory, RACM/RACT
analysis, contingency measures and RFP plan.

IV. EPA's Response to Comments

    EPA received one comment on March 9, 2015, from the Center for
Biological Diversity and Center for Environmental Health (hereafter
referred to as the ``Commenter''), in response to EPA's proposed rule
to approve the attainment demonstration for the Hillsborough Area for
the 2008 Lead NAAQS. A summary of the comment and EPA's response is
provided below.
    Comment: The Commenter mentions that FDEP fails to account for the
significant lead air pollution being generated by leaded aviation fuel
(``avgas'') from regional airports. Specifically, the Commenter states
that that the ``SIP must address the significant contributions of lead
air pollution from Hillsborough County's regional aviation airports and
include Reasonably Available Control Technology and Reasonably
Available Control Measures (``RACT/RACM'') to reduce those lead air
pollution threats.''
    Response: EPA does not believe that it is necessary for the
attainment demonstration for the Hillsborough Area for the 2008 lead
NAAQS to regulate the lead emissions resulting from avgas emitted by
aircrafts using regional airports that are located near to the
nonattainment area. First, although this is not determinative, there
are no airports within the 2008 Lead nonattainment boundary for the
Hillsborough Area to which RACT/RACM could be applied. Second, and more
importantly, available information does not indicate that lead
emissions

from nearby airports or from general aviation aircrafts that use them
are impacting receptors in the Hillsborough Area. The nonattainment
area is about a 1.14 mile radius circle encompassing the EnviroFocus
facility, the source that available information indicates is the sole
cause of the lead NAAQS violations in this nonattainment area. Prior to
making the determination concerning the appropriate boundary for the
nonattainment area, EPA reviewed the technical supporting data \1\ and
considered all the potential sources of lead in Hillsborough County.
EPA determined, based on this information that lead emissions from
aircraft combusting avgas and using the regional airports did not cause
or contribute to the monitored violations of the 2008 Lead NAAQS.
Therefore, the designation of the Hillsborough County area excluded
those airports. The closest airport where leaded avgas is used, Tampa
Executive Airport is located approximately 4 miles outside the
designated nonattainment boundary. Monitoring data from other locations
confirm that there is a sharp decrease in lead concentrations as the
distance from a lead source increases. The available technical data for
the Hillsborough Area continues to support the EPA's prior conclusion
that the airport sources of lead are located too distant from the area
to contribute significantly to receptors in the designated
nonattainment area. Consequently, EPA believes that the control
measures described in the proposed rule for the EnviroFocus facility
should be adequate to bring this area into attainment with the 2008
Lead NAAQS.
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    \1\ The analysis of the technical data supporting the boundary
can be found in the 2008 Lead Designation Technical Support Document
(TSD) for Florida. See EPA-HQ-OAR-2009-0443-0316. This document can
also be found in EPA-R04-OAR-2014-0220.
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V. Final Action

    EPA is taking final action to approve Florida's lead attainment
plan for the Hillsborough Area. EPA has determined that the SIP meets
the applicable requirements of the CAA. Specifically, EPA is taking
final action to approve Florida's June 29, 2012, SIP submission (as
amended on June 27, 2013), which includes the attainment demonstration,
base year emissions inventory, RACM/RACT analysis, contingency measures
and RFP plan.

VI. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely approves state law as meeting Federal requirements and
does not impose additional requirements beyond those imposed by state
law. For that reason, this action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where EPA or an Indian tribe has
demonstrated that a tribe has jurisdiction. In those areas of Indian
country, the rule does not have tribal implications and will not impose
substantial direct costs on tribal governments or preempt tribal law as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by June 15, 2015. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and shall not postpone the effectiveness of such rule or
action. This action may not be challenged later in proceedings to
enforce its requirements. See section 307(b)(2).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Lead, Reporting and
recordkeeping requirements.

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

    Dated: April 3, 2015.
V. Anne Heard,
Acting Regional Administrator, Region 4.
    Therefore, 40 CFR part 52 is amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

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

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

Subpart K--Florida

0
2. In Sec.  52.520, the table in paragraph (e) is amended by adding
entries for ``2008 Lead Attainment Demonstration for the Hillsborough
Area'' and ``2008 Lead Attainment Demonstration for Hillsborough Area
Amendment'' at the end of the table to read as follows:

Sec.  52.520  Identification of plan.

* * * * *
    (e) * * *

                                 EPA-Approved Florida Non-Regulatory Provisions
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                                    State effective                        Federal Register
            Provision                     date        EPA approval date         notice            Explanation
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
2008 Lead Attainment                       6/29/2012          4/16/2015  [Insert Federal
 Demonstration for Hillsborough                                           Register citation].
 Area.
2008 Lead Attainment                       6/27/2013          4/16/2015  [Insert Federal
 Demonstration for Hillsborough                                           Register citation].
 Area Amendment.
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[FR Doc. 2015-08666 Filed 4-15-15; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 80, Number 67 (Wednesday, April 8, 2015)]
[Notices]
[Pages 18850-18852]
[FR Doc No: 2015-08017]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0986]

Center for Devices and Radiological Health: Experiential Learning
Program

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA), Center for Devices and
Radiological Health (CDRH or Center) is announcing the 2015
Experiential Learning Program (ELP). This training component is
intended to provide CDRH staff with an opportunity to understand the
policies, laboratory practices, and challenges faced in broader
disciplines that impact the device development life cycle. The purpose
of this document is to invite medical device industry, academia, and
health care facilities to apply to participate in this formal training
program for FDA's medical device review staff, or to contact CDRH for
more information regarding the ELP.

DATES: Submit either an electronic or written request for participation
in the ELP by May 8, 2015. The proposal should include a description of
your facility relative to focus areas described in tables 1or 2).
Please include the Area of Interest (see tables 1or 2) that the site
visit will demonstrate to CDRH staff, a contact person, site visit
location(s), length of site visit, proposed dates, and maximum number
of CDRH staff that can be accommodated during a site visit. Proposals
submitted without this minimum information will not be considered. In
addition, please include an agenda outlining the proposed training for
the site visit. A sample request and agenda are available on the ELP
Web site at http://www.fda.gov/downloads/ScienceResearch/ScienceCareerOpportunities/UCM392988.pdf and http://www.fda.gov/scienceresearch/sciencecareeropportunities/ucm380676.htm.

ADDRESSES: Submit either electronic requests to http://www.regulations.gov or written requests to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852. Identify proposals with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Latonya Powell, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5232, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
FAX:<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    CDRH is responsible for ensuring the safety and effectiveness of
medical devices marketed in the United States. Furthermore, CDRH
assures that patients and providers have timely and continued access to
high-quality, safe, and effective medical devices. In support of this
mission, the Center launched various training and development
initiatives to enhance performance of its staff involved in regulatory
review and in the premarket review process. One of these initiatives,
the ELP Pilot, was launched in 2012 and fully implemented on April 2,
2013 (78 FR 19711). CDRH is committed to advancing regulatory science;
providing industry with predictable, consistent, transparent, and
efficient regulatory pathways; and helping to ensure consumer
confidence in medical devices marketed in the United States and
throughout the world. The ELP is intended to provide CDRH staff with an
opportunity to understand the policies, laboratory practices, and
challenges faced in broader disciplines that impact the device
development life cycle. This is a collaborative effort to enhance
communication and facilitate the premarket review process. Furthermore,
CDRH is committed to understanding current industry practices,
innovative technologies, regulatory impacts, and regulatory needs.
    These formal training visits are not intended for FDA to inspect,
assess, judge, or perform a regulatory function (e.g., compliance
inspection), but rather, they are an opportunity to provide CDRH review
staff a better understanding of the products they review. Through this
notice, CDRH is formally requesting participation from companies,
academia, and clinical facilities, including those that have previously
participated in the ELP or other FDA site visit programs.

II. ELP

A. ELP Training Component

    In this training program, groups of CDRH staff will observe
operations at research, manufacturing, academia, and health care
facilities. The focus areas and specific areas of interest for visits
may include the following:

         Table 1--Areas of Interest--Medical Devices/Technology
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            Focus area                   Specific areas of interest
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Failure analysis of orthopedic      Methods for retrieval and
 devices.                            preservation of failed implants for
                                     analysis; understanding how
                                     retrieved implants may be analyzed;
                                     methods for identifying failure
                                     modes; understanding how analysis
                                     of failed implants influences
                                     device design modifications.
Radiologic analysis of orthopedic   Methods of radiologic analysis and
 devices.                            associated data analyses;
                                     radiologic imaging core
                                     laboratories.
Automated external defibrillators   Manufacturing process; incoming
 (AEDs).                             component inspection; design
                                     verification testing; human factors
                                     testing; returned product testing
                                     (as available).
Diagnostic imaging catheters for    Manufacturing process; design
 cardiovascular diseases.            verification testing; returned
                                     product testing (as available);
                                     ultrasound, optical coherence
                                     tomography (OCT), and near infrared
                                     spectroscopy (NIS) catheters.
Endovascular grafts for treatment   Physician-sponsored clinical
 of aortic aneurysms.                studies; observation of
                                     endovascular grafting surgical
                                     procedure; surgical planning
                                     process; factors that influence
                                     device modifications (e.g., patient
                                     anatomy, patient pathology).
Animal models for evaluation of     Models of traumatic injury and
 hemostatic devices.                 severe hemorrhage; limitations of
                                     the model; understanding the
                                     relevance of the data generated
                                     from these models in evaluating
                                     hemostatic devices.
Hyaluronic acid in dermal tissue    Manufacturing process; source
 fillers.                            materials; performance testing
                                     (e.g., material characterization,
                                     biocompatibility, residence time).
Minimally invasive glaucoma         Observation of a MIGS procedure;
 surgery (MIGS) devices.             surgical planning; surgical
                                     challenges.

Neurointerventional devices.......  Stents, flow-diverters, mesh balls,
                                     coils, and other related devices;
                                     observation of surgical procedures;
                                     understanding of clinical decision
                                     making for relevant patient
                                     populations; manufacturing;
                                     performance testing.
Implantable functional electrical   Observation of implantation
 stimulation devices.                procedure; surgical challenges.
Male condoms......................  Manufacturing process; lot release
                                     testing (e.g., airburst, water
                                     leak, dimensional analysis).
Solid organ preservation devices..  Observation of organ preservation
                                     procedures; pulsatile perfusion
                                     (for either cold storage or
                                     normothermia).
Infusion pumps....................  Manufacturing process; device design
                                     considerations; patch pumps;
                                     insulin pumps; implantable infusion
                                     pumps; implantable ports.
Bone grafting materials for dental  Manufacturing process; sourcing
 applications.                       process; viral inactivation
                                     testing; animal testing.
------------------------------------------------------------------------

Table 2--Areas of Interest--In Vitro Diagnostic and Radiological Devices/
                               Technology
------------------------------------------------------------------------
            Focus area                   Specific areas of interest
------------------------------------------------------------------------
Manufacturing of glucose test       Observation of the manufacturing and
 strips and meters.                  in-process and finished device
                                     testing of glucose monitoring
                                     devices.
Manufacturing of continuous         Observation of the manufacturing and
 glucose monitoring systems and      in-process and finished device
 insulin pumps.                      testing of glucose monitors and
                                     insulin pumps.
Manufacturing of chemistry devices  Observation of the manufacturing and
                                     in-process and finished device
                                     testing of point of care chemistry
                                     cassettes/cartridges/strips for
                                     smaller chemistry analyzers used in
                                     clinical and point of care
                                     settings.
Manufacturing of chemistry          Observation of the manufacturing and
 reagent, controls and calibrators.  in-process and finished device
                                     testing of chemistry reagents,
                                     calibrators, and controls for
                                     common chemistry analytes used in a
                                     clinical laboratory setting.
Manufacturing of urine test strips  Manufacturing and observation of in
 and readers.                        process or finished device testing
                                     for urine test strips and meters in
                                     clinical laboratory and point of
                                     care testing settings.
Manufacturing and development of    Observation of manufacturing, in-
 IHC (immunohistochemistry)          process testing, and/or finished
 devices.                            device testing of IHC devices (used
                                     in the diagnostic evaluation of
                                     cancer, classification of tumors,
                                     or companion diagnostic testing).
Manufacturing and development of    Observation of the manufacturing, in-
 ISH (in situ hybridization)         process testing, or finished device
 devices.                            testing of colorimetric in situ
                                     hybridization (CISH) and/or
                                     fluorescent in situ hybridization
                                     (FISH) assays used in identifying
                                     specific nucleic acid sequences
                                     within tissue sections (for
                                     diagnostic and/or treatment
                                     decisions).
Manufacturing and development of    Observation of NGS sequencing
 NGS (next gen sequencing)           platforms, bioinformatic analysis
 platforms and devices.              of the resulting sequence
                                     information, and types of
                                     interpretative software for
                                     potential clinical purposes.
Manufacturing, development and      Observation of the manufacturing, in-
 observation of CTC (circulating     process testing, or finished device
 tumor cells) devices.               testing of CTC devices that assess
                                     the prognosis of patients with
                                     metastatic breast, colorectal, or
                                     prostate cancer (manufacturing site
                                     or research site or clinical
                                     setting).
Manufacturing, development and/or   Observe the manufacturing,
 observation of clinical mass        development and/or demonstration of
 spectrometers and high              clinical mass spectrometers and
 performance liquid chromatography   HPLC as part of laboratory workflow
 (HPLC) devices.                     including sample preparation,
                                     equipment usage, and data analysis.
Manufacturing, development and      Manufacturing, research, and
 research of flow cytometry          development of in-process testing,
 devices and components.             or finished device testing of
                                     cytometry analyzers and
                                     accompanying components.
Manufacturing of immunoassays for   Manufacturing and development of in-
 autoimmune diseases.                process testing, or finished device
                                     testing, for diagnostic evaluation
                                     and research.
Manufacturing and development of    Manufacturing and development of in-
 coagulation--point of care          process or finished device testing
 devices.                            for point of care devices such as
                                     Prothrombin Time and International
                                     Normalized Ratio (PT/INR) meters.
Manufacturing and product           Manufacturing of global hemostasis
 development of global hemostasis    testing for anti-coagulants and
 testing devices.                    anti-platelet drugs for new
                                     molecular targets to assess the
                                     level of drug-induced inhibition
                                     for qualitative and quantitative
                                     evaluation.
Manufacturing and product           Manufacturing and development of
 development of direct               assays, controls, and calibrators
 anticoagulants assays/controls/     for the detection of direct
 calibrators.                        anticoagulants.
Observation of testing of           Visit a sequencing center where
 sequencing technologies in large    various sequencing methods are used
 sequencing centers.                 for different applications other
                                     than in vitro diagnostic devices
                                     (IVD) manufacturing.
Manufacturing, and product          Visit a manufacturer of IVD designed
 evaluation of IVDs using next       for sequencing of microorganisms
 generation sequencing (NGS)         for identification purposes.
 technology.
Clinical applications-NGS in        Visit a clinical laboratory that
 practice.                           uses NGS as a diagnostic/screening
                                     tool.
Antimicrobial susceptibility        Visit to a manufacturer of
 testing (AST).                      antimicrobial susceptibility test
                                     platforms intended for use in
                                     clinical laboratory settings.

Antimicrobial susceptibility        Visit to a clinical laboratory that
 testing (AST).                      employs various AST methodologies
                                     for identification of antibiotic
                                     resistance.
------------------------------------------------------------------------

B. Site Selection

    CDRH will be responsible for CDRH staff travel expenses associated
with the site visits. CDRH will not provide funds to support the
training provided by the site to this ELP. Selection of potential
facilities will be based on CDRH's priorities for staff training and
resources available to fund this program. In addition to logistical and
other resource factors, all sites must have a successful compliance
record with FDA or another Agency with which FDA has a memorandum of
understanding. If a site visit involves a visit to a separate physical
location of another firm under contract with the site, that firm must
agree to participate in the ELP and must also have a satisfactory
compliance history.

III. Request for Participation

    Submit proposals for participation with the docket number found in
the brackets in the heading of this document. Received requests may be
seen in the Division of Dockets Management (see ADDRESSES) between 9
a.m. and 4 p.m., Monday through Friday.

    Dated: April 2, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-08017 Filed 4-7-15; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 75, Number 220 (Tuesday, November 16, 2010)]
[Notices]
[Pages 70055-70056]
[FR Doc No: 2010-28830]

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SECURITIES AND EXCHANGE COMMISION

[Release No. 34-63293; File No. SR-OCC-2010-16]

 Self-Regulatory Organizations; The Options Clearing Corporation;
Order Approving Proposed Rule Change Relating to Weekly Options And
Monthly Options

November 9, 2010.

I. Introduction

    On September 15, 2010, The Options Clearing Corporation (``OCC'')
filed with the Securities and Exchange Commission proposed rule change
SR-OCC-2010-16 pursuant to Section 19(b)(1) of the Securities Exchange
Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder.\2\ The proposed
rule change will accommodate options that expire on (a) any Friday of a
calendar month other than the third Friday of a calendar month
(``Weekly Options'') or (b) on the last trading day of a calendar month
(``Monthly Options''). The proposed rule change was published for
comment in the Federal Register on September 28, 2010.\3\ No comment
letters were received on the proposal. This order approves the
proposal.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ Securities Exchange Act Release No. 62942 (Sept. 20, 2010),
75 FR 59779.
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II. Description of the Proposal

    The purpose of the proposed rule change is to allow OCC to clear
and to settle the Weekly Options and Monthly Options on broad-based
indexes (``Weekly Index Options'' and ``Monthly Index Options,''
respectively) that were recently approved by the Commission for listing
on a pilot program basis on the Chicago Board Options Exchange,
Incorporated, (``CBOE'').\4\ Series of Weekly Index Options will expire
on a Friday of a calendar month other than the third Friday, and
Monthly Index Options will expire on the last trading day of a calendar
month. If the last trading day of the month is a Friday, CBOE would opt
to list Monthly Index Options over Weekly Index Options. Weekly Index
Options and Monthly Index Options will be European-style, P.M.-settled
contracts. These contracts will be subject to ``automatic exercise
procedures,'' which means that these contracts will automatically be
exercised at expiration if immediately prior to expiration the
contract's settlement amount equals or exceeds a predetermined amount
without the opportunity for the clearing member to submit contrary
exercise instructions.
---------------------------------------------------------------------------

    \4\ Securities Exchange Act Release No. 62911 (Sept. 14, 2010),
75 FR 57539 (Sept. 21, 2010).
---------------------------------------------------------------------------

    Weekly Options and Monthly Options proposed by CBOE can be cleared
and settled by OCC with relatively minor revisions to OCC's current By-
Laws and Rules to provide for options that expire on a monthly or
weekly schedule.\5\ In particular, OCC will amend Article I, Section 1
of its By-Laws to include definitions covering Weekly and Monthly
Options. Rule 801, which relates to the submission of exercise notices,
will be changed to permit a Weekly or Monthly Option to be exercised on
the business day before the expiration date and to include Weekly Index
Options and Monthly Index Options in the listing of options series
subject to automatic exercise. Interpretation and Policy .03 to Rule
805, which relates to expiration date exercise processing, will be
amended to permit OCC to specify time frames for submitting exercise
instructions and furnishing reports with respect to Weekly and Monthly
Options on equity interests that are different than those time frames
in effect for conventional options.\6\ A conforming change to Rule
1804, which supplements Rule 805, also will be made to add Weekly Index
Options and Monthly Index Options to the list of options series subject
to automatic exercise.
---------------------------------------------------------------------------

    \5\ OCC's By-laws and Rules already accommodate equity and index
options that expire on a day other than a Saturday following the
third Friday of the month. For example, they accommodate quarterly
options, which expire on the last business day of a calendar
quarter, and short term options, which expire a week after their
introduction for trading. Quarterly index options and short term
index options are also subject to automatic exercise procedures.
    \6\ Interpretation .03 will also be amended to clarify that it
covers equity options with non-conventional expiration dates as
opposed to index options with nonconventional expiration dates,
which are subject to automatic exercise as described in Rule 1804.
---------------------------------------------------------------------------

III. Discussion

    The Commission finds that the proposed rule change is consistent
with the requirements of the Act and the rules and regulations
thereunder applicable to DTC. In particular, the Commission believes
the proposal is consistent with Section 17A(b)(3)(F) of the Act,\7\
which requires that the rules of a registered clearing agency are
designed to, among other things, remove impediments to the perfection
of the mechanism of a national system for the prompt and accurate
clearance and settlement of securities transactions. By expanding its
clearance and settlement services to Weekly Index Options and Monthly
Index Options while using substantially the same rules and procedures
that it applies to transactions in other options with a nonconventional
expiry date, such as Quarterly Index Options, OCC will enable its
members to avail themselves of OCC's automated and time-proven
clearance and settlement services for such options, which should help
OCC to further remove impediments to and perfect the mechanism of a
national system for the prompt and accurate clearance and settlement of
securities transactions.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78q-1(b)(3)(F).
---------------------------------------------------------------------------

IV. Conclusion

    On the basis of the foregoing, the Commission finds that the
proposed rule change is consistent with the requirements of the Act and
in particular Section 17A of the Act \8\ and the rules and regulations
thereunder.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78q-1.
---------------------------------------------------------------------------

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\9\ that the proposed rule change (File No. SR-

OCC-2010-16) be and hereby is approved.\10\
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78s(b)(2).
    \10\ In approving the proposed rule change, the Commission
considered the proposal's impact on efficiency, competition and
capital formation. 15 U.S.C. 78c(f).

    For the Commission by the Division of Trading and Markets,
pursuant to delegated authority.\11\
---------------------------------------------------------------------------

    \11\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-28830 Filed 11-15-10; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 75, Number 235 (Wednesday, December 8, 2010)]
[Rules and Regulations]
[Page 76279]
[FR Doc No: 2010-30744]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2010-1058]

Drawbridge Operation Regulation; Upper Mississippi River,
Burlington, IA

AGENCY: Coast Guard, DHS.

ACTION: Notice of temporary deviation from regulations.

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

SUMMARY: The Commander, Eighth Coast Guard District, has issued a
temporary deviation from the regulation governing the operation of the
Burlington Railroad Drawbridge across the Upper Mississippi River, mile
403.1, at Burlington, Iowa. The deviation is necessary to allow the
bridge owner time to replace the swing span with a lift span and to
construct the right descending tower. This deviation allows the bridge
to be maintained in the closed-to-navigation position for sixty-two
days.

DATES: This deviation is effective from 6 a.m., December 15, 2010 to 6
a.m. February 15, 2011.

ADDRESSES: Documents mentioned in this preamble as being available in
the docket are part of docket USCG-2010-1058 and are available online
by going to http://www.regulations.gov, inserting USCG-2010-1058 in the
``Keyword'' box and then clicking ``Search''. They are also available
for inspection or copying at the Docket Management Facility (M-30),
U.S. Department of Transportation, West Building Ground Floor, Room
W12-140, 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 rule,
call or e-mail Eric A. Washburn, Bridge Administrator, Western Rivers,
Coast Guard; telephone<PHONE_NUMBER>, e-mail<EMAIL_ADDRESS>If
you have questions on viewing the docket, call Renee V. Wright, Program
Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The BNSF Railway Company requested a
temporary deviation for the Burlington Railroad Drawbridge, across the
Upper Mississippi River, mile 403.1, at Burlington, Iowa to remain in
the closed-to-navigation position for 62 days from 6 a.m., December 15,
2010 to 6 a.m., February 15, 2011 to allow the bridge owner time to
complete the Truman-Hobbs alteration. The new lift span will be set in
place and the right descending tower will be completed. The Burlington
Railroad Drawbridge currently operates in accordance with 33 CFR 117.5,
which states the general requirement that drawbridges shall open
promptly and fully for the passage of vessels when a request to open is
given in accordance with the subpart.
    There are no alternate routes for vessels transiting this section
of the Upper Mississippi River.
    The Burlington Railroad Drawbridge, in the closed-to-navigation
position, will provide a vertical clearance of 19.3 feet above normal
pool. Navigation on the waterway consists primarily of commercial tows
and recreational watercraft. The drawbridge will not be able to open
for emergencies during the construction period. This temporary
deviation has been coordinated with waterway users.
    In accordance with 33 CFR 117.35(e), the drawbridge must return to
its regular operating schedule immediately at the end of the designated
time period. This deviation from the operating regulations is
authorized under 33 CFR 117.35.

    Dated: November 26, 2010.
Eric A. Washburn,
Bridge Administrator.
[FR Doc. 2010-30744 Filed 12-7-10; 8:45 am]
BILLING CODE 9110-04-P


CA_Mobile Contribution.xls   contains the cost summary of extrapolated costs with CA mobile source rules reductions.

Ext Cost Tables.xls contains extrapolated cost calculations for glide path and no glide path sceanrios for alternate levels of the ozone standard (0.065 ppm, 0.070 ppm, and 0.075 ppm) including mobile source rule reductions in CA (these reductions are achieved at zero cost due to post 2020 implementation of these rules).

Counts of CPTON by State 070 Entire Country Totals.xls   contains the distribution of cost per ton for East, West, and CA stratified in increments of 1,000.

Slopes and Data of MC by Region.xls  contains data for regression equations to obtain the slopes of the marginal cost curves.


[Federal Register: September 2, 2009 (Volume 74, Number 169)]
[Rules and Regulations]
[Page 45307-45311]
[DOCID:fr02se09-2]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Parts 1 and 33

[Docket No. 2007-28502; Amendment No. 1-65, 33-30]
RIN 2120-AJ06

Airworthiness Standards; Aircraft Engine Standards Overtorque
Limits

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: This rule will amend the certification standards for aircraft
engines to establish requirements for approval of maximum engine
overtorque. Specifically, this action will add a new engine overtorque
test, amend engine ratings and operating limits, and define maximum
engine overtorque for certain turbopropeller and turboshaft engines.
The rule will

harmonize applicable United States (U.S.) and European standards and
simplify airworthiness approvals for import and export of aircraft
engines.

DATES: This amendment becomes effective November 2, 2009.

FOR FURTHER INFORMATION CONTACT: For technical questions concerning
this final rule contact Tim Mouzakis, Engine and Propeller Directorate,
Standards Staff, ANE-110, Federal Aviation Administration (FAA), New
England Region, 12 New England Executive Park, Burlington,
Massachusetts 01803; telephone<PHONE_NUMBER>; facsimile (781) 238-
7199; electronic mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules on aviation safety is found in
Title 49 of the United States Code. 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.
    This rulemaking is promulgated under the authority described in
subtitle VII, part A, subpart III, section 44701, ``General
requirements.'' Under that section, the FAA is charged 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, including minimum safety
standards for aircraft engines. This regulation is within the scope of
that authority because it updates the existing regulations for aircraft
engine standards overtorque limits.

Background

    Part 33 of Title 14, Code of Federal Regulations (14 CFR part 33)
prescribes airworthiness standards for original and amended type
certificates for aircraft engines. The European Aviation Safety Agency
(EASA) Certification Specification--Engines (CS-E) prescribes
corresponding airworthiness standards to certify aircraft engines in
Europe. While part 33 and the CS-E are similar, they differ in several
respects. These differences result in added costs, delays, and time
required for certification. In addition, U.S. aircraft engine
manufacturers face additional costs when seeking certification of their
engine designs by the EASA for export. CS-E contains specific standards
for approval of maximum overtorque limits.
    Currently, part 33 does not contain explicit standards for a
maximum engine overtorque limit. Engine manufacturers apply for and
obtain FAA approvals of maximum overtorque limits based on the results
of certification engine tests and analysis that do not directly address
considerations for maximum overtorque limits.
    The FAA tasked the Aviation Rulemaking Advisory Committee (ARAC),
through its Engine Harmonization Working Group (EHWG), to provide
advice and recommendations on proposed standards for engine overtorque.
We published that tasking in the Federal Register on October 20, 1998
(63 FR 56059). This final rule is based on ARAC's recommendations.

Summary of the NPRM

    The FAA published a notice of proposed rulemaking (NPRM) on March
26, 2008 (73 FR 15955). The proposal adds a new definition to Sec.
1.1, changes to Sec.  33.7, and introduces Sec.  33.84. These proposed
changes would add a new engine overtorque test, amend engine ratings
and operating limitations, and define maximum engine overtorque for
certain turbopropeller and turboshaft engines. The proposal would
harmonize U.S. and European standards for approving engine overtorque
transients for turbopropeller and turboshaft engines with free power
turbines. The comment period closed June 24, 2008.

Summary of Comments

    The FAA received four comment letters, one from a British engine
manufacturer (Rolls-Royce Corporation), one from a foreign regulatory
authority (Transport Canada), and two from law students at the
University of Central Missouri. All four comment letters support the
general intent of the proposed rule. However, Transport Canada raised
specific concerns that were addressed by clarifying revisions to
proposed Sec. Sec.  33.7 and 33.84. A detailed discussion of changes to
the final rule is presented below.

Discussion of the Final Rule

    The final rule establishes a standard for applicants to use when
applying for and obtaining approval of a maximum engine overtorque
limit. This rule harmonizes FAA and EASA standards and simplifies
airworthiness approvals for the import and export of turbopropeller and
turboshaft engines with free power turbines. The rule also improves
safety by stating clear requirements for maximum engine overtorque
limits.
    Below are specific comments from Transport Canada and our responses
to them.
    1. The approach proposed, to seek an ``approval'' for overtorque,
is inconsistent with the approach used for ``overspeed'' and
``overtemperature''. Transport Canada suggested the approach for
``overtorque'' be similar to ``overspeed'' and ``overtemperature''.
    We do not agree. Overspeed and overtemperature are transients which
are approved when they occur during normal engine operation, e.g., a
short duration transient exceedance of a rating (speed, temperature, or
torque) as the engine stabilizes at a new operating condition following
an acceleration. As proposed in the NPRM, the ``maximum engine
overtorque'' is optional to the applicant. This optional operating
condition is not an approved transient, but an ``over limit'' condition
which may occur due to a failure. The applicant can choose whether to
declare any maximum engine overtorque. However, to ensure the
regulation is clear, we have revised proposed Sec.  33.7 to clarify
that engine ratings and operating limitations include both the existing
transient engine overtorque and the new maximum engine overtorque
``over limit''. We also revised Sec.  33.87(a)(8) to clarify the
requirement applies to all transient functions, including engine
overtorque. This makes clear that transient engine overtorque is
addressed in Sec.  33.87(a)(8) and maximum engine overtorque in Sec.
33.84.
    2. The definition of ``Maximum engine overtorque'' in Sec.  1.1 is
not necessary since part 33 does not have similar definitions for
``overspeed'' or ``overtemperature''.
    The FAA does not agree. Overspeed and overtemperature in part 33
are transient events and part of the normal operation of the engine as
defined in the type design. Maximum engine overtorque is an ``over
limit'' condition that could last up to 20 seconds and is a result of
some failure. A definition in Sec.  1.1 is necessary as maximum engine
overtorque is unique in its application to turbopropeller and
turboshaft engines. Explanation is required to define the context in
which this condition would apply and specific exclusions related to it.
Transient overspeed and overtemperature are general and well understood
terms used widely throughout part 33. No maintenance action is
necessary by the aircraft operator provided the cause of the failure is
corrected, and the engine meets the new maximum engine overtorque limit
requirement.
    3. The proposed Sec.  33.84 overtorque test requirement should be
independent from the Sec.  33.87 endurance test requirement. Transport
Canada also proposed the overtorque test requirement be at least 10%
torque over

the highest torque limit for any rating longer than 2 minutes.
    We agree, in part, that the overtorque and endurance tests may be
performed separately. However, we did not set an overtorque limit
because it is the applicant's responsibility to decide the maximum
engine overtorque for the engine.
    Lastly, we made a clarifying change to wording in the first
sentence of Sec.  33.84(b)(4). This change did not alter our intent or
the meaning of the proposed regulation.

Paperwork Reduction Act

    The Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)) requires
the FAA to consider the impact of paperwork and other information
collection burdens imposed on the public. We have determined that there
are no new information collection requirements associated with this
amendment.

International Compatibility

    In keeping with U.S. obligations under the Convention on
International Civil Aviation, it is FAA policy to comply with
International Civil Aviation Organization (ICAO) Standards and
Recommended Practices to the maximum extent practicable. The FAA has
reviewed the corresponding ICAO Standards and Recommended Practices and
determined there are no differences with these regulations.

Regulatory Evaluation Summary

Regulatory Evaluation, Regulatory Flexibility Determination,
International Trade Assessment, and Unfunded Mandates Assessment

    Changes to Federal regulations must undergo several economic
analyses. First, Executive Order 12866 directs that each Federal agency
shall propose or adopt a regulation only upon a reasoned determination
that the benefits of the intended regulation justify its costs. Second,
the Regulatory Flexibility Act of 1980 (Pub. L. 96-354) requires
agencies to analyze the economic impact of regulatory changes on small
entities. Third, the Trade Agreements Act (Pub. L. 96-39) prohibits
agencies from setting standards that create unnecessary obstacles to
the foreign commerce of the United States. In developing U.S.
standards, this Trade Act requires agencies to consider international
standards and, where appropriate, that they be the basis of U.S.
standards. Fourth, the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4) requires agencies to prepare a written assessment of the costs,
benefits, and other effects of proposed or final rules that include a
Federal mandate likely to result in the expenditure by State, local, or
tribal governments, in the aggregate, or by the private sector, of $100
million or more annually (adjusted for inflation with base year of
1995). This portion of the preamble summarizes the FAA's analysis of
the economic impacts of this final rule.
    Department of Transportation Order DOT 2100.5 prescribes policies
and procedures for simplification, analysis, and review of regulations.
If the expected cost impact is so minimal that a proposed or final rule
does not warrant a full evaluation, this order permits that a statement
to that effect and the basis for it be included in the preamble if a
full regulatory evaluation of the cost and benefits is not prepared.
Such a determination has been made for this final rule. The reasoning
for this determination follows:
    This final rule coordinates FAA engine requirements with existing
EASA engine requirements that manufacturers must currently meet in
order for their engines to be used in European operations.
Consequently, this rule will allow engine manufacturers to meet one
requirement rather than separate requirements for FAA/EASA
certification. There were no public comments on the economic impact of
the NPRM. As a result, the expected outcome will be a minimal impact
with positive net benefits.
    A regulatory evaluation was not prepared. This final rule
incorporates existing certification practices, while maintaining the
existing level of safety. The benefits of this rule justify the costs
and the existing level of safety will be preserved. The Office of
Management and Budget has determined that this final rule is a
``significant regulatory action'' because it harmonizes U.S. aviation
standards with those of other civil aviation authorities.

Regulatory Flexibility Determination

    The Regulatory Flexibility Act of 1980 (Pub. L. 96-354) (RFA)
establishes ``as a principle of regulatory issuance that agencies shall
endeavor, consistent with the objectives of the rule and of applicable
statutes, to fit regulatory and informational requirements to the scale
of the businesses, organizations, and governmental jurisdictions
subject to regulation. To achieve this principle, agencies are required
to solicit and consider flexible regulatory proposals and to explain
the rationale for their actions to assure that such proposals are given
serious consideration.'' The RFA covers a wide-range of small entities,
including small businesses, not-for-profit organizations, and small
governmental jurisdictions.
    Agencies must perform a review to determine whether a rule will
have a significant economic impact on a substantial number of small
entities. If the agency determines that it will, the agency must
prepare a regulatory flexibility analysis as described in the RFA.
However, if an agency determines that a rule is not expected to have a
significant economic impact on a substantial number of small entities,
section 605(b) of the RFA provides that the head of the agency may so
certify and a regulatory flexibility analysis is not required. The
certification must include a statement providing the factual basis for
this determination, and the reasoning should be clear.
    We stated in the initial Regulatory Flexibility Analysis that we
believed the rule would be a cost-relieving rule as it harmonizes with
the EASA aviation regulations. We received no comments to the contrary.
    Therefore, as the FAA Administrator, I certify that this rule will
not have a significant economic impact on a substantial number of small
entities.

International Trade Analysis

    The Trade Agreements Act of 1979 (Pub. L. 96-39), as amended by the
Uruguay Round Agreements Act (Pub. L. 103-465), prohibits Federal
agencies from establishing any standards or engaging in related
activities that create unnecessary obstacles to the foreign commerce of
the United States. Pursuant to these Acts, the establishment of
standards is not considered an unnecessary obstacle to the foreign
commerce of the United States, so long as the standards have a
legitimate domestic objective, such as the protection of safety, and do
not operate in a manner that excludes imports that meet this objective.
The statute also requires consideration of international standards and,
where appropriate, that they be the basis for U.S. standards. This rule
uses international standards as the basis for regulation and thus is
consistent with the Trade Agreements Act.

Unfunded Mandates Assessment

    Title II of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-
4) requires each Federal agency to prepare a written statement
assessing the effects of any Federal mandate in a proposed or final
agency rule that may result in an expenditure of $100 million or more
(in 1995 dollars) in any one year by State, local, and tribal
governments, in the aggregate, or by the private sector; such a mandate
is deemed to be a ``significant

regulatory action.'' The FAA currently uses an inflation-adjusted value
of $136.1 million in lieu of $100 million. This final rule does not
contain such a mandate, therefore, the requirements of Title II of the
Act do not apply.

Executive Order 13132, Federalism

    The FAA has analyzed this proposed rule under the principles and
criteria of Executive Order 13132, Federalism. We determined that this
action will not have a substantial direct effect on the States, on the
relationship between the Federal Government and the States, or on the
distribution of power and responsibilities among the various levels of
government, and, therefore, does not have federalism implications.

Environmental Analysis

    FAA Order 1050.1E identifies FAA actions that are categorically
excluded from preparation of an environmental assessment or
environmental impact statement under the National Environmental Policy
Act in the absence of extraordinary circumstances. The FAA has
determined this rulemaking action qualifies for the categorical
exclusion identified in Chapter 3, paragraph 312d, and involves no
extraordinary circumstances.

Regulations That Significantly Affect Energy Supply, Distribution, or
Use

    The FAA has analyzed this final rule under Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use (May 18, 2001). We have determined that it is not
a ``significant energy action'' under the executive order, and is not
likely to have a significant adverse effect on the supply,
distribution, or use of energy.

Availability of Rulemaking Documents

    You can get an electronic copy of rulemaking documents using the
Internet by--
    1. Searching the Federal eRulemaking Portal (http://
www.regulations.gov);
    2. Visiting the FAA's Regulations and Policies Web page at http://
www.faa.gov/regulations_policies/; or
    3. Accessing the Government Printing Office's Web page at http://
www.gpoaccess.gov/fr/index.html.
    You can also get a copy by sending a request to the Federal
Aviation Administration, Office of Rulemaking, ARM-1, 800 Independence
Avenue, SW., Washington, DC 20591, or by calling<PHONE_NUMBER>. Make
sure to identify the amendment number or docket number of this
rulemaking.
    Anyone is able to search the electronic form of all comments
received into any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). You may review DOT's
complete Privacy Act statement in the Federal Register published on
April 11, 2000 (Volume 65, Number 70; Pages 19477-78) or you may visit
http://DocketsInfo.dot.gov.

Small Business Regulatory Enforcement Fairness Act

    The Small Business Regulatory Enforcement Fairness Act (SBREFA) of
1996 requires FAA to comply with small entity requests for information
or advice about compliance with statutes and regulations within its
jurisdiction. If you are a small entity and you have a question
regarding this document, you may contact your local FAA official, or
the person listed under the FOR FURTHER INFORMATION CONTACT heading at
the beginning of the preamble. You can find out more about SBREFA on
the Internet at http://www.faa.gov/regulationspolicies/rulemaking/
sbre_act/.

List of Subjects

14 CFR Part 1

    Air transportation, Aircraft, Aviation safety, Safety.

14 CFR Part 33

    Air transportation, Aircraft, Aviation safety, Safety.

The Amendment

0
In consideration of the foregoing, the Federal Aviation Administration
amends parts 1 and 33 of Title 14, Code of Federal Regulations (14 CFR
parts 1 and 33) as follows:

PART 1--DEFINITIONS AND ABBREVIATIONS

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

    Authority: 49 U.S.C. 106(g), 40113, 44701-44702, 44704.

0
2. Amend Sec.  1.1 by adding the definition of ``Maximum engine
overtorque'' in alphabetical order, to read as follows:

Sec.  1.1  General definitions.

* * * * *
    Maximum engine overtorque, as it applies to turbopropeller and
turboshaft engines incorporating free power turbines for all ratings
except one engine inoperative (OEI) ratings of two minutes or less,
means the maximum torque of the free power turbine rotor assembly, the
inadvertent occurrence of which, for periods of up to 20 seconds, will
not require rejection of the engine from service, or any maintenance
action other than to correct the cause.
* * * * *

PART 33--AIRWORTHINESS STANDARDS: AIRCRAFT ENGINES

0
3. The authority citation for part 33 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701-44702, 44704.

0
4. Amend Sec.  33.7 by redesignating paragraph (c)(16) as (c)(18) and
adding new paragraphs (c)(16) and (c)(17) to read as follows:

Sec.  33.7  Engine ratings and operating limitations.

* * * * *
    (c) * * *
    (16) Transient engine overtorque, and number of overtorque
occurrences.
    (17) Maximum engine overtorque for turbopropeller and turboshaft
engines incorporating free power turbines.
* * * * *

0
5. Section 33.84 is added to read as follows:

Sec.  33.84.  Engine overtorque test.

    (a) If approval of a maximum engine overtorque is sought for an
engine incorporating a free power turbine, compliance with this section
must be demonstrated by testing.
    (1) The test may be run as part of the endurance test requirement
of Sec.  33.87. Alternatively, tests may be performed on a complete
engine or equivalent testing on individual groups of components.
    (2) Upon conclusion of tests conducted to show compliance with this
section, each engine part or individual groups of components must meet
the requirements of Sec.  33.93(a)(1) and (a)(2).
    (b) The test conditions must be as follows:
    (1) A total of 15 minutes run at the maximum engine overtorque to
be approved. This may be done in separate runs, each being of at least
2\1/2\ minutes duration.
    (2) A power turbine rotational speed equal to the highest speed at
which the maximum overtorque can occur in service. The test speed may
not be more than the limit speed of take-off or OEI ratings longer than
2 minutes.
    (3) For engines incorporating a reduction gearbox, a gearbox oil
temperature equal to the maximum temperature when the maximum engine
overtorque could occur in service; and for all other engines, an oil
temperature within the normal operating range.

    (4) A turbine entry gas temperature equal to the maximum steady
state temperature approved for use during periods longer than 20
seconds when operating at conditions not associated with 30-second or 2
minutes OEI ratings. The requirement to run the test at the maximum
approved steady state temperature may be waived by the FAA if the
applicant can demonstrate that other testing provides substantiation of
the temperature effects when considered in combination with the other
parameters identified in paragraphs (b)(1), (b)(2) and (b)(3) of this
section.

0
6. Amend Sec.  33.87 by revising paragraph (a)(8) to read as follows:

Sec.  33.87  Endurance test.

    (a) * * *
    (8) If the number of occurrences of either transient rotor shaft
overspeed, transient gas overtemperature or transient engine overtorque
is limited, that number of the accelerations required by paragraphs (b)
through (g) of this section must be made at the limiting overspeed,
overtemperature or overtorque. If the number of occurrences is not
limited, half the required accelerations must be made at the limiting
overspeed, overtemperature or overtorque.
* * * * *

    Issued in Washington, DC, on August 21, 2009.
J. Randolph Babbitt,
Administrator.
[FR Doc. E9-20960 Filed 9-1-09; 8:45 am]

BILLING CODE 4910-13-P