(j) PM2.5 NAAQS means the particulate matter national ambient air
quality standards (annual and 24-hour) codified at 40 CFR Part 50.7.

(k) PM2.5 design value for a nonattainment area is the highest of the
three-year average concentrations calculated for the monitors in the
area, in accordance with 40 CFR part 50, appendix N.

(l) PM2.5 nonattainment plan precursor means SO2 and those other PM2.5
precursors emitted by sources in the State which the State must evaluate
for emission reduction measures to be included in its PM2.5
nonattainment area or maintenance area plan.

(m) PM2.5 precursor means those air pollutants other than PM2.5 direct
emissions that contribute to the formation of PM2.5.  PM2.5 precursors
include SO2, NOx, volatile organic compounds, and ammonia.

(n) Reasonable further progress (RFP) means the incremental emissions
reductions toward attainment required under section 172(c)(2) and
section 171(1).

(o) Subpart 1 means the general nonattainment plan requirements found in
subpart 1 of part D of title I of the Act.

(51.1001	Applicability of Part 51.

The provisions in subparts A- through X of this part 51 apply to areas
for purposes of the PM2.5 NAAQS to the extent they are not inconsistent
with the provisions of this subpart.

(51.1002	Submittal of State Implementation Plan.

(a) For any area designated by EPA as nonattainment for the PM2.5
NAAQS, the State must submit a State implementation plan satisfying the
requirements of section 172 of the Act and this subpart Y of 40 CFR part
51 to EPA by the date prescribed by EPA which will be no later than 3
years from the effective date of designation.

(b) The State must submit a plan consistent with the requirements of
section 110(a)(2) of the Act unless the State already has fulfilled this
obligation for the purposes of implementing the PM2.5 NAAQS.

(c) Pollutants contributing to fine particle concentrations.  The State
implementation plan must identify and evaluate sources of PM2.5 direct
emissions and PM2.5 nonattainment plan precursors in accordance with
((51.1009 and 51.1010 of this subpart.  After January 1, 2011, for
purposes of establishing emissions limits under 51.1009 and 51.1010,
States must establish such limits taking into consideration the
condensable fraction of direct PM2.5 emissions.  Prior to this date,
States are not prohibited from establishing source emission limits that
include the condensable fraction of direct PM2.5.

(1) The State must address sulfur dioxide as a PM2.5 nonattainment plan
precursor and evaluate sources of SO2 emissions in the State for control
measures.

(2) The State must address NOx as a PM2.5 nonattainment plan precursor
and evaluate sources of NOx emissions from sources in the State for
control measures, unless the State and EPA provide an appropriate
technical demonstration for a specific area showing that NOx emissions
from sources in the State do not significantly contribute to the PM2.5
nonattainment problem in the nonattainment area.

(3)  The State is not required to address VOC as a PM2.5 nonattainment
plan precursor and evaluate sources of VOC emissions from sources in the
State for control measures, unless:

(i) the State provides an appropriate technical demonstration for a
specific area showing that VOC emissions from sources in the State
significantly contribute to the PM2.5 nonattainment problem in the
nonattainment area and such demonstration is approved by EPA,; or

(ii) EPA provides such a technical demonstration.

(4)  The State is not required to address ammonia as a PM2.5
nonattainment plan precursor and evaluate sources of ammonia emissions
from sources in the State for control measures, unless:

(i) the State provides an appropriate technical demonstration for a
specific area showing that ammonia emissions in the State significantly
contribute to the PM2.5 nonattainment problem in the nonattainment area
and such demonstration is approved by EPA,; or

(ii) EPA provides such a technical demonstration.

(5) The State must submit a demonstration to reverse any presumption in
this rule for a PM2.5 precursor with respect to a particular
nonattainment area, if the administrative record related to development
of its SIP shows that the presumption is not technically justified for
that area.

(51.1003. [Reserved]

(51.1004	Attainment dates.

(a) Consistent with section 172(a)(2)(A) of the Act, the attainment date
for an area designated nonattainment for the PM2.5 NAAQS will be the
date by which attainment can be achieved as expeditiously as
practicable, but no more than five years from the date of designation.
The Administrator may extend the attainment date to the extent the
Administrator determines appropriate, for a period no greater than 10
years from the date of designation, considering the severity of
nonattainment and the availability and feasibility of pollution control
measures.

(b) In the SIP submittal for each of its nonattainment areas, the State
must submit an attainment demonstration justifying its proposed
attainment date.  For each nonattainment area, the Administrator will
approve an attainment date at the same time the Administrator approves
the attainment demonstration for the area, consistent with the
attainment date timing provision of section 172(a)(2)(A) and paragraph
(a) of this section.

(c) Upon a determination by EPA that an area designated nonattainment
for the PM2.5 NAAQS has attained the standard, the requirements for such
area to submit attainment demonstrations and associated reasonably
available control measures, reasonable further progress plans,
contingency measures, and other planning SIPs related to attainment of
the PM2.5 NAAQS shall be suspended until such time as:  the area is
redesignated to attainment, at which time the requirements no longer
apply; or EPA determines that the area has violated the PM2.5 NAAQS, at
which time the area is again required to submit such plans.

(51.1005	One-year extensions of the attainment date.

(a) Pursuant to section 172(a)(2)(C)(ii) of the Act, a State with an
area that fails to attain the PM2.5 NAAQS by its attainment date may
apply for an initial 1-year attainment date extension if the State has
complied with all requirements and commitments pertaining to the area in
the applicable implementation plan, and:

(1) For an area that violates the annual PM2.5 NAAQS as of its
attainment date, the annual average concentration for the most recent
year at each monitor is 15.0 μg/m3 or less (calculated according to the
data analysis requirements in 40 CFR part 50, appendix N).

(2) For an area that violates the 24-hour PM2.5 NAAQS as of its
attainment date, the 98th percentile concentration for the most recent
year at each monitor is 65 μg/m3 or less (calculated according to the
data analysis requirements in 40 CFR part 50, appendix N).

(b) An area that fails to attain the PM2.5 NAAQS after receiving a
1-year attainment date extension may apply for a second 1-year
attainment date extension pursuant to section 172(a)(2)(C)(ii) if the
State has complied with all requirements and commitments pertaining to
the area in the applicable implementation plan, and:

(1) For an area that violates the annual PM2.5 NAAQS as of its
attainment date, the two-year average of annual average concentrations
at each monitor, based on the first extension year and the previous
year, is 15.0 μg/m3 or less (calculated according to the data analysis
requirements in 40 CFR part 50, appendix N).

(2) For an area that violates the 24-hour PM2.5 NAAQS as of its
attainment date, the two-year average of annual 98th percentile
concentrations at each monitor, based on the first extension year and
the previous year, is 65 μg/m3 or less (calculated according to the
data analysis requirements in 40 CFR part 50, appendix N).

(51.1006	Redesignation to nonattainment following initial designations
for the PM2.5 NAAQS.

Any area that is initially designated (attainment/unclassifiable( for
the PM2.5 NAAQS may be subsequently redesignated to nonattainment if
ambient air quality data in future years indicate that such a
redesignation is appropriate.  For any such area that is redesignated to
nonattainment for the PM2.5 NAAQS, any absolute, fixed date that is
applicable in connection with the requirements of this part is extended
by a period of time equal to the length of time between the effective
date of the initial designation for the PM2.5 NAAQS and the effective
date of redesignation, except as otherwise provided in this subpart.

(51.1007	Attainment demonstration and modeling requirements.

(a) For any area designated as nonattainment for the PM2.5 NAAQS, the
State must submit an attainment demonstration showing that the area will
attain the annual and 24-hour standards as expeditiously as practicable.
 The demonstration must meet the requirements of (51.112 and Part 51,
Appendix W and must include inventory data, modeling results, and
emission reduction analyses on which the State has based its projected
attainment date.  The attainment date justified by the demonstration
must be consistent with the requirements of 40 CFR 51.1004(a).  The
modeled strategies must be consistent with requirements in (51.1009 for
RFP and in (51.1010 for RACT and RACM.  The attainment demonstration and
supporting air quality modeling should be consistent with EPA’s PM2.5
modeling guidance.

(b) Required time frame for obtaining emissions reductions.  For each
nonattainment area, the State implementation plan must provide for
implementation of all control measures needed for attainment as
expeditiously as practicable, but no later than the beginning of the
year prior to the attainment date.  Consistent with section 172(c)(1) of
the Act, the plan must provide for implementation of all RACM and RACT
as expeditiously as practicable.  The plan also must include RFP
milestones in accordance with (51.1009, and control measures needed to
meet these milestones, as necessary.

(51.1008	Emission inventory requirements for the PM2.5 NAAQS.

(a) For purposes of meeting the emission inventory requirements of
section 172(c)(3) of the Act for nonattainment areas, the State shall,
no later than three years after designation:

(1) Submit to EPA Statewide emission inventories for PM2.5 and PM2.5
precursors as required under the Consolidated Emissions Reporting Rule
(CERR) (40 CFR part 51, subpart A), or as required under any subsequent
national emission inventory reporting regulation that supersedes the
CERR.  For purposes of defining the data elements for these inventories,
the PM2.5 and PM2.5 precursor-relevant data element requirements under
40 CFR part 51 subpart A shall apply.

(2) Submit any additional emission inventory information needed to
support an attainment demonstration and RFP plan ensuring expeditious
attainment of the annual and 24-hour PM2.5 standards.

(b) AFor inventories required for submission under paragraph (a) of this
section, a baseline emission inventory is required for the attainment
demonstration required under (51.1007 and for meeting RFP requirements
under (51.1009.  As determined on the effective date of an area(s
nonattainment designation, the base year for this inventory shall be the
most recent calendar year for which a complete inventory was required to
be submitted to EPA pursuant to the Consolidated Emissions Reporting
Rule in40 CFR part 51 subpart A of this part.  The baseline emission
inventory for calendar year 2002 or other suitable year shall be used
for attainment planning and RFP plans for areas initially designated
nonattainment for the PM2.5 NAAQS in 2004-2005.

(51.1009	Reasonable further progress (RFP) requirements.

(a) Consistent with section 172(c)(2) of the Act, State implementation
plans for areas designated nonattainment for the PM2.5 NAAQS must
demonstrate reasonable further progress as provided in sections
51.1009(b) through (h).

(b) If the State submits to EPA an attainment demonstration and State
implementation plan for an area which demonstrates that it will attain
the PM NAAQS within five years of the date of designation, the State is
not required to submit a separate RFP plan.  Compliance with the
emission reduction measures in the attainment demonstration and State
implementation plan will meet the requirements for achieving reasonable
further progress for the area.

(c) For any area for which the State submits to EPA an approvable
attainment demonstration and State implementation plan that demonstrates
the area needs an attainment date of more than five years from the date
of designation, the State also must submit an RFP plan.  The RFP plan
must describe the control measures that provide for meeting the
reasonable further progress milestones for the area, the timing of
implementation of those measures, and the expected reductions in
emissions of direct PM2.5 and PM2.5 nonattainment plan precursors.  The
RFP plan is due to EPA within three years of the date of designation.

(1) For any State that submits to EPA an approvable attainment
demonstration and State implementation plan justifying an attainment
date of more than five and less than nine years from the date of
designation, the RFP plan must include 2009 emissions milestones for
direct PM2.5 and PM2.5 nonattainment plan precursors demonstrating that
reasonable further progress will be achieved for the 2009 emissions
year.

(2) For any area that submits to EPA an approvable attainment
demonstration and State implementation plan justifying an attainment
date of nine or ten years from the date of designation, the RFP plan
must include 2009 and 2012 emissions milestones for direct PM2.5 and
PM2.5 nonattainment plan precursors demonstrating that reasonable
further progress will be achieved for the 2009 and 2012 emissions years.

(d) The RFP plan must demonstrate that in each applicable milestone
year, emissions will be at a level consistent with generally linear
progress in reducing emissions between the base year and the attainment
year.

(e) For a multi-State nonattainment area, the RFP plans for each State
represented in the nonattainment area must demonstrate RFP on the basis
of common multi-State inventories. The States within which the area is
located must provide a coordinated RFP plan.  Each State in a
multi-State nonattainment area must ensure that the sources within its
boundaries comply with enforceable emission levels and other
requirements that in combination with the reductions planned in other
state(s) will provide for attainment as expeditiously as practicable and
demonstrate reasonable further progress

(f) In the benchmark RFP plan, the State must identify the pollutants
regulated under the PM2.5 nonattainment plan and specify target emission
reduction levels to be achieved during the milestone years.  In
developing the benchmark RFP plan, the State must develop emission
inventory information for the geographic area included in the plan and
conduct the following calculations:

(1) For each pollutant addressed in the attainment strategy, the full
implementation reduction is calculated by subtracting the full
implementation inventory from the baseline year inventory.

(2) The "milestone date fraction" is the ratio of the number of years
from the baseline year to the milestone inventory year divided by the
number of years from the baseline year to the full implementation year.

(3) For each pollutant addressed in the attainment strategy, a benchmark
emission reduction is calculated by multiplying the full implementation
reduction by the milestone date fraction

(4) The benchmark emission level in the milestone year is calculated for
each pollutant by subtracting the benchmark emission reduction from the
baseline year emission level.  The benchmark RFP plan is defined as a
plan that achieves benchmark emission levels for each pollutant
addressed in the attainment strategy for the area.

(5) In comparing inventories between baseline and future years for a
pollutant, the inventories must be derived from the same geographic
area. The plan must include emissions estimates for all types of
emitting sources and activities in the geographic area from which the
emission inventories for each pollutant addressed in the plan are
derived.

(6) For purposes of establishing the transportation conformity budgets
for a PM2.5 nonattainment area, the State shall include in its RFP
submittal an inventory of on-road mobile source emissions in the
nonattainment area.

(g) The RFP plan due three years after designation must demonstrate that
emissions for the milestone year are either:

(1) At levels that are roughly equivalent to the benchmark emission
levels for all applicable pollutants to be addressed in the plan; or

(2) At levels included in an alternative scenario that is projected to
result in a generally equivalent improvement in air quality by the
milestone year as would be achieved under the benchmark RFP plan.

(h) The equivalence of an alternative scenario to the corresponding
benchmark plan must be determined by comparing the expected air quality
changes of the two scenarios at the design value monitor location.  This
comparison must use the information developed for the attainment plan to
assess the relationship between emissions reductions of the pollutants
addressed in the attainment strategy and the ambient air quality
improvement for the associated ambient species.

(51.1010	Requirements for reasonably available control technology (RACT)
and reasonably available control measures (RACM).

(a) For each PM2.5 nonattainment area, the State shall submit with the
attainment demonstration a SIP revision demonstrating that it has
adopted all reasonably available control measures (including RACT for
stationary sources) necessary to demonstrate attainment as expeditiously
as practicable and to meet any RFP requirements.  The SIP revision shall
contain the list of the potential measures considered by the State, and
information and analysis sufficient to support the State’s judgment
that it has adopted all RACM, including RACT.

(b) In determining whether a particular emission reduction measure or
set of measures must be adopted as RACM under section 172(c)(1) of the
Act, the State must consider the cumulative impact of implementing the
available measures.  Potential measures that are reasonably available
considering technical and economic feasibility must be adopted as RACM
if, considered collectively, they would advance the attainment date by
one year or more.

(51.1011	Requirements for mid-course review.

(a) Any State that submits to EPA an approvable attainment plan for a
PM2.5 nonattainment area justifying an attainment date of nine or ten
years from the date of designation also must submit to EPA a mid-course
review six years from the date of designation.

(b) The mid-course review for an area must include:

(1) a review of emissions reductions and progress made in implementing
control measures addressing pollutants contributing to PM2.5
concentrations in the area

(2) an analysis of changes in ambient air quality data for the area

(3) revised air quality modeling analysis to demonstrate attainment

(4) any new or revised control measures adopted by the State, as
necessary to ensure attainment by the attainment date in the approved
SIP of the nonattainment area.

(51.1012	Requirement for contingency measures

(a) Consistent with section 172(c)(9) of the Act, the State must submit
in each nonattainment area plan specific contingency measures to be
undertaken if the area fails to make reasonable further progress, or
fails to attain the PM2.5 NAAQS by its attainment date.  The contingency
measures must take effect without significant further action by the
State or EPA.

 In the 1997 PM NAAQS revision, EPA also revised the standard for
particles with a nominal aerodynamic diameter of 10 micrometers or less
(also known as PM10).  The original PM10 standard was established in
1987.  The revised PM10 standard was later vacated by the court, and
thus the 1987 PM10 standard remains in effect.  Today(s proposed
implementation rule and guidance does not address PM10.

 Environmental Protection Agency. (1996)  Air Quality Criteria for
Particulate Matter.  Research Triangle Park, NC: National Center for
Environmental Assessment-RTP Office; report no. EPA/600/P-95/001aF-cF.
3v.

 See www.epa.gov/cair.

 See 64 FR 35714, July 1, 1999.

 See Tier II emission standards at 65 FR 6698, February 10, 2000.

 See heavy-duty diesel engine regulations at 66 FR 5002, January 18,
2001.

 For more information on the proposed nonroad diesel engine standards,
see EPA(s website:  http://www.epa.gov/nonroad/.

 NARSTO (2004) Particulate Matter Assessment for Policy Makers: A NARSTO
Assessment. P. McMurry, M. Shepherd, and J. Vickery, eds. Cambridge
University Press, Cambridge, England. ISBN 0 52 184287 5.

 The policy is the same as proposed, with the clarification regarding
downwind areas discussed above (Section A.2.b).

 The policy is the same as proposed, with the clarification regarding
downwind areas discussed above (Section A.2.b).

 The policy is the same as proposed, with the clarification regarding
downwind areas discussed above (Section A.2.b).

 The policy is the same as proposed, with the clarification regarding
downwind areas discussed above (Section A.2.b).

 More information on the Clean Air Interstate Rule is available at:
www.epa.gov/cair.

 See section 51.1005 of the proposed regulation.

 Memorandum of December 14, 2004, from Steve Page, Director, EPA Office
of Air Quality Planning and Standards to EPA Air Division Directors,
(Clean Data Policy for the Fine Particle National Ambient Air Quality
Standards.(  This document is available at:
http://www.epa.gov/pmdesignations/guidance.htm

 The recommendations contained in the modeled attainment demonstration
guidance are separate from the Agency’s future hot-spot modeling
guidance for transportation conformity purposes.

 In the March 10, 2006, final transportation conformity rule (71 FR
12468), EPA committed to develop PM2.5 and PM10 quantitative hot-spot
modeling guidance for transportation conformity determinations for
highway and transit projects of local air quality concern.

 Application of the unmonitored area analysis is limited to locations
which are appropriate to allow the comparison of predicted PM2.5
concentrations to the NAAQS, based on PM2.5 monitor siting requirements
and recommendations.

 Under the Tribal Air Rule (TAR), requirements for RACT and RACM may be
considered to be severable elements of implementation plan requirements
for Tribes. ADVANCE \d 12

 See, 44 FR 53782, September 17, 1979, and 1976 memorandum from Roger
Strelow, Assistant Administrator for Air and Waste Management to
Regional Administrators, “Guidance for Determining Acceptability of
SIP Regulations in Non-attainment Areas” (Dec. 9, 1976)

 See e.g. Workshop on Requirements for Non-atttainment Area
Plans-Compilation of Presentations (OAQPS No. 1.2-103, revised edition
April 1978)

 Under the Tribal Air Rule (TAR), requirements for RACT and RACM may be
considered to be severable elements of implementation plan requirements
for Tribes. ADVANCE \d 12

 In Sierra Club v. EPA, 294 F.3d 155 (D.C. Cir. 2002), the court stated
in upholding EPA’s statutory interpretation of RACM that the Act does
not compel a state to consider a measure without regard to whether it
would expedite attainment.

 In this notice, where we use the shorthand phrase “advance the
attainment date,” it means “advance the attainment date by one year
or more.”

 In the context of the PM10 NAAQS, EPA has concluded that “advancement
of the attainment date” should mean an advancement of at least 1
calendar year.  See State Implementation Plans; General Preamble for the
Implementation of Title I of the CAA Amendments of 1990, 57 FR 12498
(April 16, 1992).  See also Sierra Club v. EPA, 294 F.3d 155 (D.C. Cir.
2002).

 In the context of the PM10 NAAQS, EPA has concluded that “advancement
of the attainment date” should mean an advancement of at least 1one
calendar year.  See State Implementation Plans; General Preamble for the
Implementation of Title I of the CAA Amendments of 1990, 57 FR 12498
(April 16, 1992).  See also Sierra Club v. EPA, 294 F.3d 155 (D.C. Cir.
2002). ADVANCE \d 12

 The EPA believes that it is not necessary to identify every possible
variation of every type of control measure, or all possible combinations
of technologies and measures that would apply to a given source or
activity if the State has properly characterized the potentially
available emissions reductions and their costs.   For example, EPA
believes that the State can conduct a thorough analysis of VMT reduction
measures without including every possible level or stringency of
implementation of certain possible measures or combinations of measures
for reducing VMT, so long as those measures would not affect the overall
assessment of VMT reduction capabilities and the associated costs.

 For example, see past EPA guidance on PM2.5 control technologies:
Stationary Source Control Techniques Document for Fine Particulate
Matter (EPA-452/R-97-001), EPA Office of Air Quality Planning and
Standards, October 1998.

 Stationary Source Control Techniques Document for Fine Particulate
Matter (EPA-452/R-97-001), EPA Office of Air Quality Planning and
Standards, October 1998. See also:  Controlling SO2 Emissions: A Review
of Technologies (EPA/600/R-00/093), EPA Office of Research and
Development, November 2000.

 See EPA’s website for more information:
http://www.epa.gov/ttn/emc/monitor.html.

 EPA Air Pollution Control Cost Manual - Sixth Edition (EPA
452/B-02-001), EPA Office of Air Quality Planning and Standards,
Research Triangle Park, NC, Jan 2002. ADVANCE \d 12

10 U.S. EPA, 2003 Technical Support Package for Clear Skies; U.S. EPA,
2003. See also:  Draft Regulatory Impact Analysis: Control of Emissions
from Nonroad Diesel Engines. United States Environmental Protection
Agency Office of Air and Radiation EPA420-R-03-008, April 2003. ADVANCE
\d 12

  There are a number of sources of information on technologies for
reducing emissions of PMPM2.5 and its precursors, including:  Stationary
Source Control Techniques Document for Fine Particulate Matter
(EPA-452/R-97-001), EPA Office of Air Quality Planning and Standards;
STAPPA and ALAPCO Controlling Fine Particulate Matter Under the Clean
Air Act:  A Menu of Options; Control Measures “White Papers” from
the Lake Michigan Air Directors Consortium (  HYPERLINK
"http://www.ladco.org"  www.ladco.org );  New Jersey “Reducing Air
Pollution Together” workgroups (  HYPERLINK
"http://www.nj.gov/dep/airworkgroups/"
http://www.nj.gov/dep/airworkgroups/ ); California SB 656 Program to
identify available PM measures (  HYPERLINK
"http://www.arb.ca.gov/pm/pmmeasures/pmmeasures.htm"
http://www.arb.ca.gov/pm/pmmeasures/pmmeasures.htm ).  .  Links are
provided to a number of national, state and local air quality agency
sites from EPA’s PM2.5 website: http://www.epa.gov/pm/measures.html

11 12See Clean School Bus USA program at
http://www.epa.gov/cleanschoolbus/.  See also:  AWhat You Should Know
About Diesel Exhaust and School Bus Idling", (June 2003,
EPA420-F-03-021) at
http://www.epa.gov/otaq/retrofit/documents/f03021.pdf. ADVANCE \d 12

12 See EPA’s voluntary diesel retrofit program web site at
http://www.epa.gov/otaq/retrofit/overfleetowner.htm. ADVANCE \d 12

13 See EPA’s voluntary diesel retrofit program web site at
http://www.epa.gov/otaq/retrofit/idling.htm. ADVANCE \d 12

14 See EPA’s website on transportation control measures at
http://www.epa.gov/otaq/transp/traqtcms.htm. ADVANCE \d 12

15 See EPA’s web site on nonroad engines, equipment, and vehicles at
http://www.epa.gov/otaq/nonroad.htm. ADVANCE \d 12

 Under the ozone program, EPA has identified presumptive levels of
control for RACT for various source categories through control
techniques guidelines.   When RACT is a specified level of control, RACT
(unlike RACM) is unrelated to pollution levels and attainment needs of
individual areas.

 Because CAIR is designed to achieve highly cost effective emission
reductions to abate interstate pollution transport and to provide
flexibility on the location of reductions, the projected impact of CAIR
in reducing nonattainment area EGU emissions varies significantly by
area.

 See the regulatory impact analysis chapter on air quality for the 2006
PM NAAQS review at
http://www.epa.gov/ttn/ecas/regdata/RIAs/Chapter%204--Air%20Quality.pdf.

 EPA’s CAIR-RACT presumption also would not apply if a State required
sources other than EGUs to achieve a portion of the reductions required
by CAIR (e.g., the State’s CAIR SIP achieved some reductions from EGUs
but took credit for non-EGU reductions achieved under new, more
stringent requirements implemented to meet NOx SIP call caps).  Under
the CAIR rule such a State would not be eligible to participate in the
EPA-administered CAIR trading system.

16 There are some MACT categories for which it may not be possible to
determine the degree of VOC reductions from the MACT standard without
additional analysis; for example, the miscellaneous metal parts and
products (40 CFR part 60, subpart MMMM) due to the uncertainty of the
compliance method that will be selected. ADVANCE \d 12

 There are some MACT categories for which it may not be possible to
determine the degree of VOC reductions from the MACT standard without
additional analysis; for example, the miscellaneous metal parts and
products (40 CFR part 60, subpart MMMM) due to the uncertainty of the
compliance method that will be selected.

17 The consolidated emissions reporting rule was published in the
Federal Register on June 10, 2002, pages 39602-39616. ADVANCE \d 12

 The consolidated emissions reporting rule was published in the Federal
Register on June 10, 2002, pages 39602-39616. ADVANCE \d 12

 The RFP test uses inventories for the full year, e.g. the year of 2009
or the year of 2012.  EPA does not specifically require that the
relevant measures be implemented by the beginning of the year, but RFP
inventories must reflect the fact that measures that are implemented
later in the year have correspondingly less impact on the year’s
annual total emissions.

111 Emissions Inventory Guidance for Implementation of Ozone and
Particulate Matter National Ambient Air Quality Standards (NAAQS) and
Regional Haze Regulations,(  EPA-454/R-05-001, August 2005.

 Emissions Inventory Guidance for Implementation of Ozone and
Particulate Matter National Ambient Air Quality Standards (NAAQS) and
Regional Haze Regulations,(  EPA-454/R-05-001, November 2005.

  “Optimized Method 202 Sampling Train to Minimize the Biases
Associated with Method 202 Measurement of Condensable Particulate Matter
Emissions,” John Richards, Tom Holder, and David Goshaw, Air Control
Techniques, P.C.; Air & Waste Management Association, Hazardous Waste
Combustion Specialty Conference AWM, November 2-3, 2005, St. Louis, MO.

 U.S. Environmental Protection Agency. PM-10 SIP Development Guideline.
Office of Air Quality Planning and Standards, Research Triangle Park,
NC. EPA Publication No. EPA-450/2-86-001. June 1987.

  The General Preamble is available online at   HYPERLINK
"http://www.epa.gov/ttn/oarpg/t1pfpr.html"
http://www.epa.gov/ttn/oarpg/t1pfpr.html .

 Clean Air Act Advisory Committee, Recommendations to the Clean Air Act
Advisory Committee - Phase I and Next Steps, Air Quality Management Work
Group, Environmental Protection Agency,   HYPERLINK
"http://www.epa.gov/air/caaac/pdfs/report1-17-05.pdf"
http://www.epa.gov/air/caaac/pdfs/report1-17-05.pdf , January 2005.

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 Option Paper 4 - Providing Guidance Regarding The Use Of Emissions
Factors For Purposes Other Than Emissions Inventories, September 2005,
http://www.epa.gov/ttn/chief/efpac/projects.html

119 See 40 CFR (( 70.5(c)(3)(i), 70.5(b), and 70.7(a)(1)(i); 40 CFR ((
71.5(c)(3)(i), 71.5(b), and 71.7(a)(1)(i).

 White Paper Number 2 for Improved Implementation of The Part 70
Operating Permits Program, Lydia N. Wegman, Deputy Director, Office of
Air Quality Planning and Standards, March 5, 1996 (  HYPERLINK
"http://www.epa.gov/ttn/oarpg/t5wp.html"
http://www.epa.gov/ttn/oarpg/t5wp.html

 See 40 CFR 70.5(c)(3)(i), 70.5(b), and 70.7(a)(1)(i); 40 CFR
71.5(c)(3)(i), 71.5(b), and 71.7(a)(1)(i).

 For background information on issues surrounding implementation of the
PM2.5 NAAQS, see the EPA memo entitled “Implementation of New Source
Review Requirements in PM-2.5 Nonattainment Areas,” from Stephen D.
Page, Director, Office of Air Quality Planning and Standards, to
Regional Air Directors, Regions I-X, dated April 5, 2005.

 For background information on regulated air pollutants, see the EPA
memo entitled “Definition of Regulated Air Pollutant for Purposes of
Title V,” from Lydia N. Wegman, Deputy Director, Office of Air Quality
Planning and Standards, to Air Division Directors, Regions I-X, dated
April 26, 1993.

120 The PM2.5 monitoring regulations are located at 40 CFR Part 58.

 The PM2.5 monitoring regulations are located at 40 CFR Part 58.

 See 62 FR 38652-38760, National Ambient Air Quality Standards for
Particulate Matter, Final Rule; also 40 CFR Part 50.

Compilation of sections sent to OMB as of 9/15/06

 PAGE

 PAGE  3

Compilation of sections sent to OMB as of 9/15/06

 PAGE

 PAGE   354

Compilation of sections sentDraft 11/27/06
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[Federal Register Volume 76, Number 187 (Tuesday, September 27, 2011)]
[Notices]
[Pages 59759-59761]
[FR Doc No: 2011-24734]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-65376; File No. SR-FINRA-2011-046]

Self-Regulatory Organizations; Financial Industry Regulatory
Authority, Inc.; Notice of Filing and Immediate Effectiveness of
Proposed Rule Change To Revise the Series 17 Examination Program

September 21, 2011.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on September 7, 2011, Financial Industry Regulatory Authority, Inc.
(``FINRA'') (f/k/a National Association of Securities Dealers, Inc.
(``NASD'')) filed with the Securities and Exchange Commission (``SEC''
or ``Commission'') the proposed rule change as described in Items I and
II below, which Items have been prepared by FINRA. FINRA has designated
the proposed rule change as ``constituting a stated policy, practice,
or interpretation with respect to the meaning, administration, or
enforcement of an existing rule'' under Section 19(b)(3)(A)(i) of the
Act \3\ and Rule 19b-4(f)(1) thereunder,\4\ which renders the proposal
effective upon receipt of this filing by the Commission. The Commission
is publishing this notice to solicit comments on the proposed rule
change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(i).
    \4\ 17 CFR 240.19b-4(f)(1).
---------------------------------------------------------------------------

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

    FINRA is filing revisions to the content outline and selection
specifications for the United Kingdom Securities Representative (Series
17) examination program.\5\ The proposed revisions update the material
to reflect changes to the laws, rules and regulations covered by the
examination and to better reflect the functions and associated tasks
performed by a United Kingdom Securities Representative and the
relationships between the different components of the outline. FINRA is
not proposing any textual changes to the By-Laws, Schedules to the By-
Laws, or Rules of FINRA.
---------------------------------------------------------------------------

    \5\ FINRA also is proposing corresponding revisions to the
Series 17 question bank, but based upon instruction from the
Commission staff, FINRA is submitting SR-FINRA-2011-046 for
immediate effectiveness pursuant to Section 19(b)(3)(A) of the Act
and Rule 19b-4(f)(1) thereunder, and is not filing the question bank
for Commission review. See Letter to Alden S. Adkins, Senior Vice
President and General Counsel, NASD Regulation, from Belinda Blaine,
Associate Director, Division of Market Regulation, SEC, dated July
24, 2000. The question bank is available for Commission review.
---------------------------------------------------------------------------

    The revised content outline is attached.\6\ The Series 17 selection
specifications have been submitted to the Commission under separate
cover with a request for confidential treatment pursuant to SEA Rule
24b-2.\7\
---------------------------------------------------------------------------

    \6\ The Commission notes that the content outline is attached to
the filing, not to this Notice.
    \7\ 17 CFR 240.24b-2.
---------------------------------------------------------------------------

    The text of the proposed rule change is available on FINRA's Web
site at http://www.finra.org, at the principal office of FINRA and at
the Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, FINRA included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. FINRA has prepared summaries, set forth in sections A,
B, and C below, of the most significant aspects of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, Proposed Rule Change

1. Purpose
    Section 15A(g)(3) of the Act \8\ authorizes FINRA to prescribe
standards of training, experience, and competence for persons
associated with FINRA members. In accordance with that provision, FINRA
has developed examinations that are designed to establish that persons
associated with FINRA members have attained specified levels of
competence and knowledge, consistent with applicable registration
requirements under FINRA Rules. FINRA periodically reviews the content
of the examinations to determine whether revisions are necessary or
appropriate in view of changes pertaining to the subject matter covered
by the examinations.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78o-3(g)(3).
---------------------------------------------------------------------------

    NASD Rules and the rules incorporated from NYSE \9\ require that a

``representative,'' as defined in the respective rules,\10\ register
and qualify as a General Securities Representative,\11\ subject to
certain exceptions. For those representatives who are not engaged in
municipal securities activities, the NASD and NYSE Rules provide that
registration and qualification as a United Kingdom Securities
Representative is equivalent to registration and qualification as a
General Securities Representative.\12\
---------------------------------------------------------------------------

    \9\ The current FINRA rulebook consists of (1) FINRA Rules; (2)
NASD Rules; and (3) rules incorporated from NYSE (``Incorporated
NYSE Rules'') (together, the NASD Rules and Incorporated NYSE Rules
are referred to as the ``Transitional Rulebook''). While the NASD
Rules generally apply to all FINRA members, the Incorporated NYSE
Rules apply only to those members of FINRA that are also members of
the NYSE (``Dual Members''). The FINRA Rules apply to all FINRA
members, unless such rules have a more limited application by their
terms. For more information about the rulebook consolidation
process, see Information Notice, March 12, 2008 (Rulebook
Consolidation Process). For convenience, the Incorporated NYSE Rules
are referred to as the NYSE Rules.
    \10\ See NASD Rule 1031(b) and NYSE Rule 10.
    \11\ See NASD Rules 1031(a) and 1032(a); NYSE Rules 345.10 and
345.15(2); and NYSE Rule Interpretation 345.15/02.
    \12\ See NASD Rule 1032(a)(2)(B) and NYSE Information Memorandum
91-09 (March 1991). FINRA is filing proposed revisions to the Series
7 examination program in conjunction with this filing. See SR-FINRA-
2011-045.
---------------------------------------------------------------------------

    The Series 17 examination is the FINRA examination that qualifies
an individual to function as a United Kingdom Securities
Representative.\13\
---------------------------------------------------------------------------

    \13\ Candidates must also satisfy certain prerequisite training
and competence requirements of the United Kingdom's Financial
Services Authority (``FSA'') and be registered and in good standing
with the FSA. More information regarding the prerequisite
requirements is available on FINRA's Web site at: http://www.finra.org/Industry/Compliance/Registration/QualificationsExams/RegisteredReps/Qualifications/P121264.
---------------------------------------------------------------------------

    A committee of industry representatives, together with FINRA staff,
recently undertook a review of the Series 17 examination program. As a
result of this review, FINRA is proposing to make revisions to the
content outline to reflect changes to the laws, rules and regulations
covered by the examination and to better reflect the functions and
associated tasks performed by a United Kingdom Securities
Representative and the relationship between the different components of
the content outline.
Current Outline
    The current Series 17 content outline is divided into five critical
functions performed by a United Kingdom Securities Representative. The
following are the number of questions associated with each of the five
functions, denoted 1 through 5:

1: 8 questions.
2: 28 questions.
3: 24 questions.
4: 33 questions.
5: 7 questions.

    Each function also includes the tasks associated with performing
that function. Further, the outline includes a section listing the
applicable laws, rules and regulations with cross-references to the
related functions and associated tasks.
Proposed Revisions
    FINRA is proposing to divide the Series 17 content outline into
five major job functions performed by a United Kingdom Securities
Representative. The following are the five major job functions, denoted
F1 through F5, and the number of questions associated with each of the
five functions:

    F1: Seeks Business for the Broker-Dealer through Customers and
Potential Customers, 20 questions;
    F2: Evaluates Customers' Other Security Holdings, Financial
Situation and Needs, Financial Status, Tax Status, and Investment
Objectives, 15 questions;
    F3: Opens Accounts, Transfers Assets, and Maintains Appropriate
Account Records, 25 questions;
    F4: Provides Customers with Information on Investments and Makes
Suitable Recommendations, 20 questions; and
    F5: Obtains and Verifies Customer's Purchase and Sales
Instructions, Enters Orders, and Follows Up, 20 questions.
    Additionally, each job function includes certain tasks describing
activities associated with performing that function. FINRA is proposing
to revise the outline to better reflect the functions and associated
tasks performed by a United Kingdom Securities Representative.
    The revised content outline also includes a knowledge section
describing the underlying knowledge required to perform the major job
functions and associated tasks and a rule section listing the laws,
rules and regulations related to the job functions, associated tasks
and knowledge statements. There are cross-references within each
section to the other applicable sections.
    As noted above, FINRA also is proposing to revise the content
outline to reflect changes to the laws, rules and regulations covered
by the examination. Among other revisions, FINRA is proposing to revise
the content outline to reflect the adoption of rules in the
consolidated FINRA rulebook (e.g., FINRA Rule 3240 (Borrowing From or
Lending to Customers)).
    FINRA is proposing similar changes to the Series 17 selection
specifications and question bank. The number of questions on the Series
17 examination will remain at 100 multiple-choice questions. However,
candidates will have 150 minutes (2\1/2\ hours) to complete the
examination, whereas today they have two hours to complete the
examination.
    Currently, a score of 70 percent is required to pass the
examination. A score of 72 percent will be required to pass the revised
examination.
Availability of Content Outlines
    The revised Series 17 content outline will be available on FINRA's
Web site, at http://www.finra.org/brokerqualifications/exams.
    FINRA is filing the proposed rule change for immediate
effectiveness. FINRA proposes to implement the revised Series 17
examination program on November 7, 2011. FINRA will announce the
proposed rule change and the implementation date in a Regulatory
Notice.
2. Statutory Basis
    FINRA believes that the proposed revisions to the Series 17
examination program are consistent with the provisions of Section
15A(b)(6) of the Act,\14\ which requires, among other things, that
FINRA rules must be designed to prevent fraudulent and manipulative
acts and practices, to promote just and equitable principles of trade,
and, in general, to protect investors and the public interest, and
Section 15A(g)(3) of the Act,\15\ which authorizes FINRA to prescribe
standards of training, experience, and competence for persons
associated with FINRA members. FINRA believes that the proposed
revisions will further these purposes by updating the examination
program to reflect changes to the laws, rules and regulations covered
by the examination and to better reflect the functions and associated
tasks performed by a United Kingdom Securities Representative.
---------------------------------------------------------------------------

    \14\ 15 U.S.C. 78o-3(b)(6).
    \15\ 15 U.S.C. 78o-3(g)(3).
---------------------------------------------------------------------------

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

    FINRA does not believe that the proposed rule change will result in
any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act.

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

    Written comments were neither solicited nor received.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A) of the Act \16\ and paragraph (f)(1) of Rule 19b-4
thereunder.\17\ FINRA proposes to implement the revised Series 17
examination program on November 7, 2011. FINRA will announce the
implementation date in a Regulatory Notice.
---------------------------------------------------------------------------

    \16\ 15 U.S.C. 78s(b)(3)(A).
    \17\ 17 CFR 240.19b-4(f)(1).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule should be approved or disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-FINRA-2011-046 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-FINRA-2011-046. This
file number should be included on the subject line if e-mail is used.
To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments,
all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for Web site
viewing and printing in the Commission's Public Reference Room, 100 F
Street, NE., Washington, DC 20549, on official business days between
the hours of 10 a.m. and 3 p.m. Copies of such filing also will be
available for inspection and copying at the principal office of FINRA.
All comments received will be posted without change; the Commission
does not edit personal identifying information from submissions. You
should submit only information that you wish to make available
publicly. All submissions should refer to File Number SR-FINRA-2011-046
and should be submitted on or before October 18, 2011.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\18\

    \18\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Elizabeth M. Murphy,
Secretary.
[FR Doc. 2011-24734 Filed 9-26-11; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 84, Number 199 (Tuesday, October 15, 2019)]
[Proposed Rules]
[Pages 55073-55075]
[FR Doc No: 2019-22393]

========================================================================
Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.

========================================================================

Federal Register / Vol. 84 , No. 199 / Tuesday, October 15, 2019 /
Proposed Rules

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2019-0665; Product Identifier 2019-NE-25-AD]
RIN 2120-AA64

Airworthiness Directives; General Electric Company Turbofan
Engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: The FAA proposes to adopt a new airworthiness directive (AD)
for certain General Electric Company (GE) CF34-1A, CF34-3A, CF34-3A1,
CF34-3A2, CF34-3B, and CF34-3B1 model turbofan engines. This proposed
AD was prompted by an in-flight failure of a fan blade that led to an
in-flight shutdown. This proposed AD would require removal and
replacement of the affected fan blades. The FAA is proposing this AD to
address the unsafe condition on these products.

DATES: The FAA must receive comments on this proposed AD by November
29, 2019.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, 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: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For service information identified in this NPRM, contact General
Electric Company, GE Aviation, Room 285, 1 Neumann Way, Cincinnati, OH
45215; phone:<PHONE_NUMBER>; email<EMAIL_ADDRESS>You
may view this service information at the FAA, Engine and Propeller
Standards Branch, 1200 District Avenue, Burlington, MA 01803. For
information on the availability of this material at the FAA, call 781-
238-7759.

Examining the AD Docket

    You may examine the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2019-
0665; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this NPRM, the regulatory evaluation, any comments received, and other
information. The street address for Docket Operations is listed above.
Comments will be available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Christopher McGuire, Aerospace
Engineer, ECO Branch, FAA, 1200 District Avenue, Burlington, MA 01803;
phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under the ADDRESSES section. Include ``Docket No. FAA-2019-0665;
Product Identifier 2019-NE-25-AD'' at the beginning of your comments.
The FAA specifically invites comments on the overall regulatory,
economic, environmental, and energy aspects of this NPRM. The FAA will
consider all comments received by the closing date and may amend this
NPRM because of those comments.
    The FAA will post all comments received, without change, to http://www.regulations.gov, including any personal information you provide.
The FAA will also post a report summarizing each substantive verbal
contact received about this NPRM.

Discussion

    The FAA was notified of an in-flight failure of a fan blade
installed on a GE CF34-3B1 engine. As a result of this failure, the
crew shut down the engine and performed an air turnback and a safe
landing. A review by GE determined that a lance peen was not performed
on certain fan blades after a repair done at a repair station between
2007 and 2009. Fan blades can lose their compressive residual stress
during certain electron beam weld repairs and hot form repairs. The
loss of mechanical properties is restored with the lance peening
process called out in these repairs. During an audit, GE identified the
fan blades referenced in paragraph (c) of this AD as suspected of
missing lance peening. This condition, if not addressed, could result
in failure of one or more engines, loss of thrust control, and loss of
the airplane.

Related Service Information Under 1 CFR Part 51

    The FAA reviewed GE Service Bulletin (SB) CF34-BJ S/B 72-0306,
dated September 27, 2017, and GE SB CF34-AL S/B 72-0314, dated
September 27, 2017. GE SB CF34-BJ S/B 72-0306 describes procedures for
removal and replacement of affected fan blades installed on CF34-1A, -
3A, -3A1, -3A2, and -3B model turbofan engines. GE SB CF34-AL S/B 72-
0314 describes procedures for removal and replacement of affected fan
blades installed on CF34-3A1 and -3B1 model turbofan engines.
    This service information is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in the ADDRESSES section.

Other Related Service Information

    The FAA also reviewed GE SB CF34-AL S/B 72-0148, Revision 05, dated
July 23, 2015; and GE SB CF34-BJ S/B 72-0123, Revision 04, dated
October 21, 2015. GE SB CF34-AL S/B 72-0148 describes procedures for
repair of fan blades installed on GE CF34-3A1 and -3B1 model turbofan
engines. GE SB CF34-BJ S/B 72-0123 describes procedures for repair of
fan blades installed on GE CF34-1A, -3A, -3A1, -3A2, and -3B model
turbofan engines.

FAA's Determination

    The FAA is proposing this AD because we evaluated all the relevant
information and determined the unsafe condition described previously is
likely to exist or develop in other products of the same type design.

Proposed AD Requirements

    This proposed AD would require removal and replacement of the
affected fan blades.

Costs of Compliance

    The FAA estimates that this proposed AD affects 121 engines
installed on airplanes of U.S. registry.
    The FAA estimates the following costs to comply with this proposed
AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
                Action                         Labor cost           Parts cost        product        operators
----------------------------------------------------------------------------------------------------------------
Remove and replace fan blade..........  2 work-hours x $85 per           $11,000         $11,170      $1,351,570
                                         hour = $170.
----------------------------------------------------------------------------------------------------------------

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.
    The FAA is 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.
    This AD is issued in accordance with authority delegated by the
Executive Director, Aircraft Certification Service, as authorized by
FAA Order 8000.51C. In accordance with that order, issuance of ADs is
normally a function of the Compliance and Airworthiness Division, but
during this transition period, the Executive Director has delegated the
authority to issue ADs applicable to engines, propellers, and
associated appliances to the Manager, Engine and Propeller Standards
Branch, Policy and Innovation Division.

Regulatory Findings

    The FAA determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would 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 proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Will not affect intrastate aviation in Alaska, 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.

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 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 adding the following new airworthiness
directive (AD):

General Electric Company: Docket No. FAA-2019-0665; Product
Identifier 2019-NE-25-AD.

 (a) Comments Due Date

    The FAA must receive comments by November 29, 2019.

 (b) Affected ADs

    None.

 (c) Applicability

    This AD applies to General Electric Company (GE) CF34-1A, CF34-
3A,CF34-3A1, CF34-3A2, CF34-3B, and CF34-3B1 model turbofan engines
having a fan blade with a part number listed in Planning
Information, paragraph 1.A., of GE Service Bulletin (SB) CF34-AL S/B
72-0314, dated September 27, 2017 or of GE SB CF34-BJ S/B 72-0306,
dated September 27, 2017, and with any serial number listed in
paragraph 4., Appendix A, of GE SB CF34-AL S/B 72-0314 or of GE SB
CF34-BJ S/B 72-0306.

 (d) Subject

    Joint Aircraft System Component (JASC) Code 7220, Turbine Engine
Inlet Section.

 (e) Unsafe Condition

    This AD was prompted by an in-flight failure of a fan blade that
led to an in-flight shutdown. The FAA is issuing this AD to prevent
failure of the fan blade. The unsafe condition, if not addressed,
could result in failure of one or more engines, loss of thrust
control, and loss of the airplane.

 (f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

 (g) Required Actions

    Remove the affected fan blades from service within 90 days after
the effective date of this AD and replace with a part eligible for
installation.

 (h) Definition

    A part that is eligible for installation is any fan blade other
than those identified by paragraph (c) of this AD or a fan blade
that has been repaired per GE SB CF34-AL S/B 72-0148, Revision 05,
dated July 23, 2015; or GE SB CF34-BJ S/B 72-0123, Revision 04,
dated October 21, 2015.

 (i) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, ECO Branch, FAA, has the authority to approve
AMOCs for this AD, if requested using the procedures found in 14 CFR
39.19. In accordance with 14 CFR 39.19, send your request to your
principal inspector or local Flight Standards District Office, as
appropriate. If sending information directly to the manager of the
certification office, send it to the attention of the person
identified in paragraph (j)(1) of this AD. You may email your
request to<EMAIL_ADDRESS>    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.

 (j) Related Information

    (1) For more information about this AD, contact Christopher
McGuire, Aerospace Engineer, ECO Branch, FAA, 1200 District Avenue,
Burlington, MA, 01803; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>;
email<EMAIL_ADDRESS>    (2) For service information identified in this AD, contact
General Electric Company, GE Aviation, Room 285, 1 Neumann Way,
Cincinnati, OH 45215; phone:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>You may view this referenced service
information at the FAA, Engine and Propeller Standards Branch, 1200
District Avenue, Burlington, MA 01803. For information on the

availability of this material at the FAA, call<PHONE_NUMBER>.

    Issued in Burlington, Massachusetts, on October 7, 2019.
Robert J. Ganley,
Manager, Engine & Propeller Standards Branch, Aircraft Certification
Service.
[FR Doc. 2019-22393 Filed 10-11-19; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 85, Number 239 (Friday, December 11, 2020)]
[Rules and Regulations]
[Pages 79835-79836]
[FR Doc No: 2020-27244]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2020-0826; Airspace Docket No. 20-AEA-15]
RIN 2120-AA66

Amendment of Class E Airspace; Dubois, PA

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action amends Class E surface airspace and Class E
airspace extending upward from 700 feet above the surface in Dubois,
PA, due to the decommissioning of the Clarion Very High Frequency
Omnidirectional Range Tactical Air Navigational System (VORTAC) and
cancellation of the associated instrument approach procedure at Dubois
Regional Airport. This action also updates the name of the airport, as
well as the name and geographic coordinates of Penn Highlands
Healthcare-Dubois Heliport. Controlled airspace is necessary for the
safety and management of instrument flight rules (IFR) operations in
the area.

DATES: Effective 0901 UTC, February 25, 2021. The Director of the
Federal Register approves this incorporation by reference action under
Title 1 Code of Federal Regulations part 51, subject to the annual
revision of FAA Order 7400.11 and publication of conforming amendments.

ADDRESSES: FAA Order 7400.11E, Airspace Designations and Reporting
Points, and subsequent amendments can be viewed online at https://www.faa.gov/air_traffic/publications/. For further information, you can
contact the Airspace Policy Group, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; Telephone: (202) 267-
8783. The Order is also available for inspection at the National
Archives and Records Administration (NARA). For information on the
availability of FAA Order 7400.11E at NARA, email<EMAIL_ADDRESS>or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.

FOR FURTHER INFORMATION CONTACT: John Fornito, Operations Support
Group, Eastern Service Center, Federal Aviation Administration, 1701
Columbia Avenue, College Park, GA 30337; Telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding 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 I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it amends Class E airspace in Dubois, PA, to support IFR operations
in the area.

History

    The FAA published a notice of prosed rulemaking in the Federal
Register (85 FR 59465, September 22, 2020) for Docket No. FAA-2020-0826
to amend Class E surface airspace from a 4-mile radius to a 4.8-mile
radius, and remove all extensions. Also, the FAA proposed the amendment
of Class E airspace extending upward from 700 feet above the surface in
Dubois, PA, from a 8.5-mile radius to a 9.2-mile radius. In addition,
the FAA proposed to update the geographic coordinates and name of the
airport, as well as Penn Highland Healthcare-Dubois Heliport to
coincide with the FAA's aeronautical database.
    Subsequent to publication, the FAA found the names of DuBois
Regional Airport and Penn Highland Healthcare-DuBois Heliport required
updating. The correct names are Dubois Regional Airport and Penn
Highlands Healthcare-Dubois Heliport. This action makes the update.
    Interested parties were invited to participate in this rulemaking
effort by submitting written comments on the proposal to the FAA. One
comment supporting this action was received.
    Class E airspace designations are published in Paragraph 6005 of
FAA Order 7400.11E, dated July 21, 2020, and effective September 15,
2020, which is incorporated by reference in 14 CFR 71.1. The Class E
airspace designations listed in this document will be published
subsequently in the Order.

Availability and Summary of Documents for Incorporation by Reference

    This document amends FAA Order 7400.11E, Airspace Designations and
Reporting Points, dated July 21, 2020, and effective September 15,
2020. FAA Order 7400.11E is publicly available as listed in the
ADDRESSES section of this document. FAA Order 7400.11E lists Class A,
B, C, D, and E airspace areas, air traffic routes, and reporting
points.

The Rule

    This amendment to Title 14 Code of Federal Regulations (14 CFR)
part 71 amends Class E surface airspace and Class E airspace extending
upward from 700 feet above the surface at Dubois Regional Airport,
(previously Du Bois-Jefferson County Airport), Dubois, PA, due to the
decommissioning of the Clarion VORTAC and cancellation of the
associated approach. In addition, the FAA updates the airport's name
and the name and geographic coordinates of Penn Highlands Healthcare-
Dubois Heliport, (previously Du Bois Regional Medical Center) to
coincide with the FAA's aeronautical database.
    Class E airspace designations are published in Paragraphs 6002 and
6005, respectively, of FAA Order 7400.11E, dated July 21, 2020, and
effective September 15, 2020, which is incorporated by reference in 14
CFR 71.1. The Class E airspace designations listed in this document
will be published subsequently in the Order.
    FAA Order 7400.11, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

Regulatory Notices and Analyses

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore: (1) Is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a regulatory evaluation as the
anticipated impact is so minimal. Since this is a routine matter that
only affects air traffic procedures an air navigation, it is certified
that this rule, when promulgated, does not have a significant economic
impact on a substantial number of small entities under the criteria of
the Regulatory Flexibility Act.

Environmental Review

    The FAA has determined that this action qualifies for categorical
exclusion under the National Environmental Policy Act in accordance
with FAA Order 1050.1F, ``Environmental Impacts: Policies and
Procedures,'' paragraph 5-6.5a. This airspace action is not expected to
cause any potentially significant environmental impacts, and no
extraordinary circumstances exist that warrant preparation of an
environmental assessment.

Lists of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

    In consideration of the foregoing, the Federal Aviation
Administration amends 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for part 71 continues to read as follows:

    Authority:  49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1   [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.11E,
Airspace Designations and Reporting Points, dated July 21, 2020,
effective September 15, 2020, is amended as follows:

Paragraph 6002 Class E Surface Airspace.

* * * * *

AEA PA E2 Dubois, PA [Amended]

Dubois Regional Airport, PA
    (Lat. 41[deg]10'42'' N, long. 78[deg]53'55'' W)

    That airspace extending upward from the surface within a 4.8-
mile radius of Dubois Regional Airport. This Class E airspace is
effective during the dates and times established in advance by a
Notice to Airmen. The effective date and time will thereafter be
continuously published in the Chart Supplement.

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth.

* * * * *

AEA PA E5 Dubois, PA [Amended]

Dubois Regional Airport, PA
    (Lat. 41[deg]10'42'' N, long. 78[deg]53'55'' W)
Penn Highlands Healthcare-Dubois Heliport Point In Space Coordinates
    (Lat. 41[deg]06'52'' N, long. 78[deg]46'26'' W)

    That airspace extending upward from 700 feet or more above the
surface within a 9.2-mile radius of Dubois Regional Airport and
within a 6-mile radius of the Point In Space Coordinates serving
Penn Highlands Healthcare-Dubois Heliport.

    Issued in College Park, Georgia, on December 7, 2020.
Andreese C. Davis,
Manager, Airspace & Procedures Team South, Eastern Service Center, Air
Traffic Organization.
[FR Doc. 2020-27244 Filed 12-10-20; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 83, Number 203 (Friday, October 19, 2018)]
[Rules and Regulations]
[Pages 52968-52970]
[FR Doc No: 2018-22786]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 878

[Docket No. FDA-2018-N-3598]

Medical Devices; General and Plastic Surgery Devices;
Classification of the Light Based Energy Source Device for Topical
Application

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA or we) is classifying
the light based energy source device for topical application into class
II (special controls). The special controls that apply to the device
type are identified in this order and will be part of the codified
language for the light based energy source device for topical
application's classification. We are taking this action because we have
determined that classifying the device into class II (special controls)
will provide a reasonable assurance of safety and effectiveness of the
device. We believe this action will also enhance patients' access to
beneficial innovative devices, in part by reducing regulatory burdens.

DATES: This order is effective October 19, 2018. The classification was
applicable on October 18, 2012.

FOR FURTHER INFORMATION CONTACT: Neil Ogden, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. G414, Silver Spring, MD, 20993-0002,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the light based energy source
device for topical application as class II (special controls), which we
have determined will provide a reasonable assurance of safety and
effectiveness. In addition, we believe this action will enhance
patients' access to beneficial innovation, in part by reducing
regulatory burdens by placing the device into a lower device class than
the automatic class III assignment.
    The automatic assignment of class III occurs by operation of law
and without any action by FDA, regardless of the level of risk posed by
the new device. Any device that was not in commercial distribution
before May 28, 1976, is automatically classified as, and remains
within, class III and requires premarket approval unless and until FDA
takes an action to classify or reclassify the device (see 21 U.S.C.
360c(f)(1)). We refer to these devices as ``postamendments devices''
because they were not in commercial distribution prior to the date of
enactment of the Medical Device Amendments of 1976, which amended the
Federal Food, Drug, and Cosmetic Act (FD&C Act).
    FDA may take a variety of actions in appropriate circumstances to
classify or reclassify a device into class I or II. We may issue an
order finding a new device to be substantially equivalent under section
513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a predicate device that
does not require premarket approval. We determine whether a new device
is substantially equivalent to a predicate by means of the procedures
for premarket notification under section 510(k) of the FD&C Act (21
U.S.C. 360(k)) and part 807 (21 CFR part 807).
    FDA may also classify a device through ``De Novo'' classification,
a common name for the process authorized under section 513(f)(2) of the
FD&C Act. Section 207 of the Food and Drug Administration Modernization
Act of 1997 (Pub. L. 105-115) established the first procedure for De
Novo classification. Section 607 of the Food and Drug Administration
Safety and Innovation Act (Pub. L. 112-144) modified the De Novo
application process by adding a second procedure. A device sponsor may
utilize either procedure for De Novo classification.
    Under the first procedure, the person submits a 510(k) for a device
that has not previously been classified. After receiving an order from
FDA classifying the device into class III under section 513(f)(1) of
the FD&C Act, the person then requests a classification under section
513(f)(2).
    Under the second procedure, rather than first submitting a 510(k)
and then a request for classification, if the person determines that
there is no legally marketed device upon which to base a determination
of substantial equivalence, that person requests a classification under
section 513(f)(2) of the FD&C Act.
    Under either procedure for De Novo classification, FDA shall
classify the device by written order within 120 days. The
classification will be according to the criteria under section
513(a)(1) of the FD&C Act. Although the device was automatically placed
within class III, the De Novo classification is considered to be the
initial classification of the device.
    We believe this De Novo classification will enhance patients'
access to beneficial innovation, in part by reducing regulatory
burdens. When FDA classifies a device into class I or II via the De
Novo process, the device can serve as a predicate for future devices of
that type, including for 510(k)s (see 21 U.S.C. 360c(f)(2)(B)(i)). As a
result, other device sponsors do not have to submit a De Novo request
or premarket approval application (PMA) to market a substantially
equivalent device (see 21 U.S.C. 360c(i), defining ``substantial
equivalence''). Instead, sponsors can use the less-burdensome 510(k)
process, when necessary, to market their device.

II. De Novo Classification

    For this device, FDA issued an order on June 10, 2009, finding the
ViruLite Cold Sore Machine not substantially equivalent to a predicate
not subject to PMA. Thus, the device remained in class III in
accordance with section 513(f)(1) of the FD&C Act when we issued the
order.
    On June 30, 2009, Pacer Therapeutics, Ltd. submitted a request for
De Novo classification of the ViruLite Cold Sore Machine. FDA reviewed
the request in

order to classify the device under the criteria for classification set
forth in section 513(a)(1) of the FD&C Act.
    We classify devices into class II if general controls by themselves
are insufficient to provide reasonable assurance of safety and
effectiveness, but there is sufficient information to establish special
controls that, in combination with the general controls, provide
reasonable assurance of the safety and effectiveness of the device for
its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the
information submitted in the request, we determined that the device can
be classified into class II with the establishment of special controls.
FDA has determined that these special controls, in addition to the
general controls, will provide reasonable assurance of the safety and
effectiveness of the device.
    Therefore, on October 18, 2012, FDA issued an order to the
requester classifying the device into class II. FDA is codifying the
classification of the device by adding 21 CFR 878.4860. We have named
the generic type of device light based energy source device for topical
application, and it is identified as a device that emits light energy
at near infrared spectrum and is applied externally to the surface of
herpes simplex labialis lesions on or around the lips.
    FDA has identified the following risks to health associated
specifically with this type of device and the measures required to
mitigate these risks in table 1.

 Table 1--Light Based Energy Source Device for Topical Application Risks
                         and Mitigation Measures
------------------------------------------------------------------------
            Identified risks                   Mitigation measures
------------------------------------------------------------------------
Redness and discomfort.................  Clinical performance testing,
                                          Usability testing, and
                                          Labeling.
Burns and blisters.....................  Clinical performance testing,
                                          Usability testing, and
                                          Labeling.
Adverse tissue reaction................  Biocompatibility evaluation.
Infection/transmissibility.............  Labeling, Cleaning and
                                          disinfection validation, and
                                          Usability testing.
Electrical shock.......................  Electrical safety testing and
                                          Labeling.
Electromagnetic incompatibility........  Electromagnetic compatibility
                                          testing and Labeling.
User error.............................  Usability testing and Labeling.
Ocular injury..........................  Labeling and Non-clinical
                                          performance testing for ocular
                                          safety.
------------------------------------------------------------------------

    FDA has determined that special controls, in combination with the
general controls, address these risks to health and provide reasonable
assurance of safety and effectiveness. For a device to fall within this
classification, and thus avoid automatic classification in class III,
it would have to comply with the special controls named in this final
order. The necessary special controls appear in the regulation codified
by this order. This device is subject to premarket notification
requirements under section 510(k) of the FD&C Act.

III. Analysis of Environmental Impact

    We have determined under 21 CFR 25.34(b) that this action is of a
type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

IV. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to
previously approved collections of information found in other FDA
regulations and guidance. These collections of information are subject
to review by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections
of information in the guidance document ``De Novo Classification
Process (Evaluation of Automatic Class III Designation)'' have been
approved under OMB control number 0910-0844; the collections of
information in 21 CFR part 814, subparts A through E, regarding
premarket approval, have been approved under OMB control number 0910-
0231; the collections of information in 21 CFR part 820, regarding
quality system regulation, have been approved under OMB control number
0910-0073; the collections of information in part 807, subpart E,
regarding premarket notification submissions, have been approved under
OMB control number 0910-0120; and the collections of information in 21
CFR part 801, regarding labeling, have been approved under OMB control
number 0910-0485.

List of Subjects in 21 CFR Part 878

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
878 is amended as follows:

PART 878--GENERAL AND PLASTIC SURGERY DEVICES

0
1. The authority citation for part 878 continues to read as follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
2. Add Sec.  878.4860 to subpart E to read as follows:

Sec.  878.4860   Light based energy source device for topical
application.

    (a) Identification. The device emits light energy at near infrared
spectrum and is applied externally to the surface of herpes simplex
labialis lesions on or around the lips.
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) The technical parameters of the device, including wavelength,
treatment time, treatment area, energy density, spot size, and power,
must be characterized.
    (2) The cleaning and disinfection instructions for the device must
be validated.
    (3) The device must be demonstrated to be biocompatible.
    (4) Performance testing must validate electromagnetic compatibility
(EMC), ocular safety, and electrical safety of the device.
    (5) Labeling must direct end-users to contact the device
manufacturer and MedWatch if they experience any adverse events when
using this device.
    (6) Labeling must include specific information pertinent to use of
the device by the intended patient population and the treatment
regimen.
    (7) Simulated use testing must include information from a
usability, label comprehension and self-selection study to demonstrate
that the device can be used by the intended patient population without
any assistance.
    (8) Clinical data must show adequate reduction in time to healing
and assess risks of redness, discomfort, burns, and blisters.

    Dated: October 15, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-22786 Filed 10-18-18; 8:45 am]
 BILLING CODE 4164-01-P