[Federal Register Volume 85, Number 30 (Thursday, February 13, 2020)]
[Proposed Rules]
[Pages 8233-8240]
[FR Doc No: 2020-02819]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R02-OAR-2018-0684; FRL-10005-32-Region 2]

Approval and Promulgation of Implementation Plans; New York;
Reasonably Available Control Technology for the 2008 8-Hour Ozone
National Ambient Air Quality Standards in the New York Metropolitan
Area Moderate Nonattainment Area

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve a State Implementation Plan (SIP) submitted by the State of New
York for purposes of implementing Reasonably Available Control
Technology (RACT) in the New York portion of the New York-Northern New
Jersey-Long Island NY-NJ-CT nonattainment area (New York Metropolitan
Area or NYMA) for the 2008 8-hour ozone National Ambient Air Quality
Standard (NAAQS) as it relates to major sources emitting oxides of
nitrogen (NOX), control technique guidelines (CTG) for
sources of volatile organic compounds (VOCs), and non-CTG major sources
of VOCs. In addition, the EPA is proposing to approve portions of the
SIP revision submitted by New York to address the 2008 ozone NAAQS that
certify that the State has satisfied the requirements for an enhanced
vehicle Inspection and Maintenance Program, an emissions statement
program, and a nonattainment new source review program. The EPA is also
proposing to approve New York's RACT plan as it applies to the CTG for
industrial cleaning solvents and to solvent metal cleaning processes.
This action is being taken in accordance with the requirements of the
Clean Air Act.

DATES: Written comments must be received on or before March 16, 2020.

ADDRESSES: Submit your comments, identified by Docket ID Number EPA-
R02-OAR-2018-0684 at http://www.regulations.gov. Follow the online
instructions for submitting comments. Once submitted, comments cannot
be edited or removed from Regulations.gov. The EPA may publish any
comment received to its public docket. Do not submit electronically any
information you consider to be Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute.
Multimedia submissions (audio, video, etc.) must be accompanied by a
written comment. The written comment is considered the official comment
and should include discussion of all points you wish to make. The EPA
will generally not consider comments or comment contents located
outside of the primary submission (i.e., on the web, cloud, or other
file sharing system). For additional submission methods, the full EPA
public comment policy, information about CBI or multimedia submissions,
and general guidance on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Omar Hammad, Environmental Protection
Agency, 290 Broadway, New York, New York 10007-1866, at<PHONE_NUMBER>,
or by email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:  The Supplementary Information section is
arranged as follows:

Table of Contents

I. What action is the EPA proposing?
II. What is the background for this proposed rulemaking?
III. What did New York submit?
IV. What is the EPA's evaluation of New York's SIP submittal?
V. Statutory and Executive Order Reviews

I. What action is the EPA proposing?

    The EPA is proposing to approve a (SIP) submitted by the State of
New York on November 13, 2017 for purposes of implementing Reasonably
Available Control Technology (RACT) \1\ for the 2008 8-hour ozone
National Ambient Air Quality Standard (NAAQS or standard) for the New
York portion of the NYMA classified as moderate nonattainment. The
State's November 2017 SIP submittal consists of a demonstration that
New York meets the RACT requirements for the two precursors for ground-
level ozone, i.e., NOX and volatile organic compounds
(VOCs), set forth by the Clean Air Act (CAA or Act) with respect to the
2008 8-hour ozone standard. The EPA is proposing to approve New York's
November 2017 RACT SIP submittal as it applies to non-control technique
guideline (non-CTG) major sources of VOCs, CTG sources of VOCs and to
major sources of NOX.
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    \1\ The EPA has defined RACT as the lowest emission limitation
that a particular source is capable of meeting by the application of
control technology that is reasonably available considering
technological and economic feasibility (44 FR 53762, September 17,
1979).
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    The EPA is also proposing to approve the following New York
certifications that were submitted as part of SIP

revisions to address the moderate area 2008 8-hour NAAQS. The
certifications, that are applicable state-wide and therefore to the New
York portion of NYMA, are: (1) That nonattainment new source review
(NNSR) applies to NOX and VOC emissions from stationary
sources; (2) that the State has satisfied the requirements for an
enhanced vehicle Inspection and Maintenance Program; and (3) that the
State has satisfied the requirements for an emissions statement
program.
    New York certified that there are no sources located in the State
for the following six CTGs: Manufacture of Vegetable Oils; Manufacture
of High-Density Polyethylene, Polypropylene and Polystyrene Resins;
Natural Gas/Gasoline Processing Plants; Air Oxidation Processes in
Synthetic Organic Chemical Manufacturing Industry; Fiberglass Boat
Manufacturing Materials; Agricultural Pesticides. The EPA is not
proposing any action on this certification since we previously approved
the State's negative declaration for these six CTGs. 82 FR 58342
(December 12, 2017); 40 CFR 52.1683 (a) and (b).
    The EPA is proposing to approve New York's RACT plan as it applies
to the CTG for industrial cleaning solvents. On December 12, 2017 (82
FR 58342), the EPA published a conditional approval of New York's
state-wide RACT submittal, dated December 22, 2014, as supplemented on
September 6, 2017, for purposes of satisfying the 2008 8-hour ozone
standard RACT requirement as it applies to CTG requirements for VOC
sources for industrial cleaning solvents. In its letter dated September
6, 2017, New York committed to adopt, by November 30, 2018, a revised
Part 226 of Title 6 of the New York Codes, Rules and Regulations (6
NYCRR), entitled, ``Solvent Metal Cleaning Processes,'' that will
address the CTG for industrial cleaning solvents. In the conditional
approval, EPA stated that if New York failed to meet its commitment
within the one-year time period specified by CAA section 110(k)(4), the
conditional approval will, by operation of law, become a disapproval.
New York's response to the conditional approval was submitted to the
EPA on November 5, 2019, approximately 11 months late, so the
conditional approval converted to a disapproval. The EPA is now
proposing to approve New York's state-wide RACT submittal dated
December 22, 2014, as supplemented on September 6, 2017 and November 5,
2019, for purposes of satisfying the 2008 8-hour ozone standard RACT
requirement, as it applies to CTG requirements for VOC sources for
industrial cleaning solvents.
    The EPA is also proposing to approve New York's RACT plan as it
applies to solvent cleaning processes. The EPA approved \2\ New York's
RACT plan for solvent metal cleaning processes under the 1-hour ozone
standard and is now proposing to approve New York's revised and more
stringent requirements as the RACT plan for solvent metal cleaning
processes for the 2008 8-hour ozone standard.
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    \2\ Approval and Promulgation of Implementation Plans; New York
State Implementation Plan Revision; 1-Hour Ozone Control Programs.
(69 FR 3237, January 23, 2004).
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II. What is the background for this proposed rulemaking?

    In 2008, EPA revised the health-based NAAQS for ozone, setting it
at 0.075 parts per million (ppm) averaged over an 8-hour time frame.
The EPA determined that the revised 8-hour standard would be more
protective of human health, especially with regard to children and
adults who are active outdoors and individuals with a pre-existing
respiratory disease such as asthma.
    On April 30, 2012, the EPA finalized its attainment/nonattainment
designations for areas across the country with respect to the 2008 8-
hour ozone standard. 77 FR 30087 (May 21, 2012). This action became
effective on July 20, 2012. The two 8-hour ozone marginal nonattainment
areas located in New York State are the New York portion of NYMA and
the Jamestown nonattainment area. The remainder of New York State was
designated as unclassifiable/attainment. The New York portion of the
NYMA, is composed of the five boroughs of New York City and the
surrounding counties of Nassau, Suffolk, Westchester, Rockland and the
Shinnecock Indian Nation.\3\ 40 CFR 81.333. The Jamestown nonattainment
area is composed of Chautauqua County. In 2016, the EPA determined that
Jamestown attained the 2008 ozone standard by the July 20, 2015
attainment date and that the NYMA nonattainment area did not attain the
2008 ozone standard by the applicable attainment date and was
reclassified from a marginal to a moderate nonattainment area. 81 FR
26697 (May 4, 2016).\4\ State attainment plans for moderate
nonattainment areas were due by January 1, 2017. 81 FR 26697. Jamestown
remains classified as a marginal nonattainment area until the State
submits a redesignation request \5\ to the EPA. Since the NYMA was
reclassified to a moderate nonattainment area, New York, on November
13, 2017, submitted a new RACT determination as well as revisions
related to the 2008 8-hour ozone moderate standard. This proposed
action addresses New York's RACT determination and State certifications
portions of New York's November 13, 2017, submittal for the New York
portion of NYMA. The remaining portions of New York's attainment
demonstration for the 2008 8-hour ozone standard, moderate designation,
for the New York portion of NYMA will be addressed in a separate
rulemaking action.
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    \3\ Information pertaining to areas of Indian country is
intended for CAA planning purposes only and is not an EPA
determination of Indian country status or any Indian country
boundary. The EPA lacks the authority to establish Indian country
land status and makes no determination of Indian country boundaries
at 77 FR 30087 (May 21, 2012).
    \4\ In 2019 the NY-NJ-CT nonattainment area was reclassified to
serious nonattainment. 84 FR 44238 (August 23, 2019). The serious
area attainment date and the deadline for RACT measures not tied to
attainment is July 20, 2021. 84 FR 44238.
    \5\ EPA's determination of attainment does not constitute a
redesignation to attainment. Redesignation requires states to meet a
number of additional statutory criteria, including the EPA approval
of a state plan demonstrating maintenance of the air quality
standard for 10 years after redesignation. (81 FR 26697 at 26701;
May 4, 2016). On October 2, 2018 (83 FR 49492), the EPA made a final
determination that the Jamestown Area has attained the 2008 8-hour
ozone NAAQS based upon complete, quality-assured, and certified
ambient air monitoring data that shows the Area has monitored
attainment of the 2008 8-hour ozone NAAQS for both the 2012-2014 and
2015-2017 monitoring periods. This final action does not constitute
a redesignation to attainment. The Jamestown area will remain
nonattainment for the 2008 8-hour ozone standard until such time as
EPA determines that the Jamestown area meets the CAA requirements
for designation to attainment, including an approved maintenance
plan.
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    The counties in the New York portion of NYMA (and part of Orange
County) were previously classified under the 1979 1-hour ozone NAAQS as
severe, requiring RACT, while the remaining counties in the State were
subject to RACT as part of the moderate classification or as part of
the Ozone Transport Region (OTR).\6\ Under the 2008 8-hour ozone
standard, in areas classified as moderate or located in the OTR (which
includes all of New York State), a RACT determination is required for
major stationary sources that emit or have the potential to emit 50
tons per year for VOC and 100 tons per year for NOX. As
required by the anti-backsliding provisions of the CAA, for purposes of
the RACT analysis for the 2008 ozone standard, New York retained the 1-
hour ozone plan emission threshold of 25 tons per year or more for
either NOX or VOC for major sources in

the New York portion of NYMA and portions of Orange County that were
classified as severe under the 1979 1-hour standard.
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    \6\ CAA section 184(a) established a single ozone transport
region (OTR) comprising all or part of 12 eastern states and the
District of Columbia.
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    Sections 172(c)(1) and 182(b)(2) of the CAA require states to
implement RACT in areas classified as moderate (and higher)
nonattainment for ozone, while section 184(b)(1)(B) of the CAA requires
VOC RACT in states located in the OTR and section 182(f) requires
NOX RACT be adopted in the OTR. These areas are required to
implement RACT for all major VOC and NOX emission sources
and for all sources covered by a CTG. A CTG is a document issued by the
EPA which establishes a ``presumptive norm'' for RACT for a specific
VOC source category. A related set of documents, Alternative Control
Techniques (ACT) documents, exists primarily for NOX control
requirements. States must submit rules, or negative declarations when
the State has no such sources, for CTG source categories, but not for
sources in ACT categories. However, RACT must be imposed on major
sources of NOX, and some of those major sources may be
within a sector covered by an ACT document.
    On March 6, 2015 (80 FR 12264), the EPA published a final rule that
outlines the obligations that areas found to be in nonattainment of the
2008 ozone NAAQS need to address. This rule, herein referred to as the
``2008 ozone implementation rule,'' contains, among other things, a
description of the EPA's expectations for states with RACT obligations.
The 2008 ozone implementation rule provides that states could meet RACT
through the establishment of new or more stringent requirements that
meet RACT control levels, through a certification that previously
adopted RACT controls in the SIP, that were approved by the EPA under a
prior ozone NAAQS, represent adequate RACT control levels for
attainment of the 2008 ozone NAAQS, or a combination of these two
approaches. In addition, a state must submit a negative declaration in
instances where there are no CTG sources. The 2008 ozone implementation
rule requires that states with nonattainment areas were required to
submit RACT SIPs to EPA within two years from the effective date of
nonattainment designation or by July 20, 2014.

III. What did New York submit?

    On November 13, 2017, the New York Department of Environmental
Conservation (NYSDEC or New York) submitted to the EPA a formal
revision to its SIP.\7\ The SIP revision consists of information
documenting how New York complied with the RACT requirements and the
elements of an attainment demonstration for the 2008 8-hour ozone NAAQS
for the New York portion of NYMA classified as moderate
nonattainment.\8\ In its November 2017 RACT submittal, New York
certifies that the State's submittal addresses the RACT requirements
for the 2008 8-hour ozone standard, with the exception of the CTG for
industrial cleaning solvents and for the 2016 oil and natural gas
industry CTG. In New York's December 2014 state-wide RACT submittal, as
supplemented on September 6, 2017, the State committed to revise 6
NYCRR Part 226, ``Solvent Metal Cleaning Processes,'' and to fulfill
that commitment by no later than November 30, 2018. New York
supplemented the RACT submittal on November 5, 2019, with a revised
version of 6 NYCRR Part 226, to address the CTG for industrial cleaning
solvents. In addition, in New York's November 2017 RACT SIP submittal,
the State commits to adopting a new regulation to address EPA's CTG for
the oil and natural gas industry (EPA-453/B-16-001, October 20, 2016).
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    \7\ The submittal is entitled ``New York State Implementation
Plan for the 2008 Ozone National Ambient Air Quality Standard,
Reasonably Available Control Technology Demonstration for the New
York Metropolitan Area Moderated Nonattainment Area, final proposed
revision, November 2017.''
    \8\ New York, in its November 2017 submittal, requests that EPA
reclassify the NYMA to serious nonattainment to allow New York, New
Jersey and Connecticut adequate time to develop complete SIPs that
forecast attainment in the NYMA by the serious area deadline of July
20, 2021. Effective September 23, 2019, EPA reclassified the NYMA to
serious nonattainment, giving each state until July 20, 2021 to
achieve the 2008 ozone standard. 84 FR 44238 (Aug. 23, 2019).
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    New York's November 2017 RACT submittal states that it evaluated
its existing RACT regulations, used in its December 2014 state-wide
RACT determination to meet the 1997 8-hour ozone standard, to ascertain
whether the same regulations constitute RACT for the 2008 8-hour ozone
standard. In making its new 8-hour ozone RACT determination, New York
relied on EPA's RACT Question and Answer document (May 18, 2006) and
the most recent emission control technology and cost evaluations to
determine what constitutes technically and economically feasible
controls for specific sources. Accordingly, the basic framework for New
York's November 2017 RACT SIP determination for the New York portion of
NYMA moderate nonattainment area is described as follows:
     Identify all source categories covered by CTG and ACT
documents.
     Identify applicable regulations that implement RACT.
     Certify that the existing level of controls for the 1997
8-hour ozone standard equals RACT under the 2008 8-hour ozone standard
in certain cases.
     Declare which sources covered by a CTG and ACT do not
exist within the state and/or that RACT is not applicable in certain
cases.
     Identify and evaluate applicability of RACT to individual
sources whose source category does not have a presumptive emission
limit covered by a state-wide regulation.
     Identify potential RACT revisions.
     Identify statewide applicability of nonattainment new
source review (NNSR).
    New York states that its November 2017 RACT SIP submittal for the
New York portion of NYMA moderate nonattainment area supports the
primary findings of the December 2014 state-wide RACT SIP: Namely, that
New York State (and therefore the New York portion of the NYMA) has
fulfilled the CAA obligations for RACT in a moderate nonattainment
area, with the exception of the industrial cleaning solvents CTG,
issued by the EPA in September 2006, for which New York has since
finalized a rulemaking to include those requirements in Part 226.\9\ In
addition, in the November 2017 submittal, New York notes that it
intends to adopt and implement the 2016 oil and natural gas industry
CTG and that sources subject to the CTG will be regulated through a new
rule that is not yet adopted. New York certified that the RACT
requirements for the 2008 8-hour ozone NAAQS for the New York portion
of NYMA moderate nonattainment area have been satisfied and are
consistent with the most recent control technology and economic
considerations. The following discusses the results of New York's
analysis of RACT under the basic framework identified above.
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    \9\ New York adopted Part 226 with an effective date of November
1, 2019.
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CTGs and ACTs

    New York reviewed its existing RACT regulations adopted under the
1979 1-hour and 1997 8-hour ozone standard to identify source
categories covered by the EPA's CTG and ACT documents. New York's RACT
SIP submittal lists the CTG and ACT documents and corresponding State
RACT regulations that cover the CTG and ACT sources included in New
York's emissions inventory. For non-CTG major sources,

6 NYCRR Part 212, ``General Process Emission Sources,'' regulates RACT
compliance for VOC and NOX. Major sources of NOX
are regulated by 6 NYCRR Part 227-2, ``Reasonably Available Control
Technology (RACT) for Major Facilities of Oxides of Nitrogen
(NOX).'' In its November 2017 SIP submittal, New York
certified that major non-CTG sources are covered by the Part 212 RACT
regulation.
    Except as noted, New York has implemented RACT controls state-wide
for all CTGs that the EPA had issued as of October 2016. The following
table lists the RACT controls that have been promulgated in 6 NYCRR and
the corresponding EPA SIP approval dates.

------------------------------------------------------------------------
                                                          EPA approval
        NY  regulation                   Title                date
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Part 205......................  Architectural and       12/13/04, 69 FR
                                 Industrial              72118.
                                 Maintenance Coatings.
Part 211......................  General Prohibitions..  7/12/13, 78 FR
                                                         41846.
Part 212......................  General Process         7/12/13, 78 FR
                                 Emission Sources.       41486.
Part 214......................  Byproduct Coke Oven     7/20/06, 71 FR
                                 Batteries.              41163.
Part 216......................  Iron and/or Steel       7/20/06, 71 FR
                                 Processes.              41163.
Part 220......................  Portland Cement and     7/12/13, 78 FR
                                 Glass Plants.           41486.
Part 223......................  Petroleum Refineries..  7/19/85, 50 FR
                                                         29382.
Part 224......................  Sulfuric and Nitric     7/19/85, 50 FR
                                 Acid Plants.            29382.
Part 226......................  Solvent Metal Cleaning  1/23/04, 69 FR
                                 Processes.              3237.
Part 227-2....................  RACT for Oxides of      7/12/13, 78 FR
                                 Nitrogen (NOX).         41486.
Part 228......................  Surface Coating         3/04/14, 79 FR
                                 Processes.              12084.
Part 229......................  Petroleum and Volatile  12/23/97, 62 FR
                                 Organic Liquid          67006.
                                 Storage and Transfer.
Part 230......................  Gasoline Dispensing     4/30/98, 63 FR
                                 Sites and Transport     23668.
                                 Vehicles.
Part 232......................  Dry Cleaning..........  6/17/85, 50 FR
                                                         25079.
Part 233......................  Pharmaceutical and      12/23/97, 62 FR
                                 Cosmetic Processes.     67006.
Part 234......................  Graphic Arts..........  3/08/12, 77 FR
                                                         13974.
Part 236......................  Synthetic Organic       7/27/93, 58 FR
                                 Chemical                40059.
                                 Manufacturing
                                 Facility Component
                                 Leaks.
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    New York's November 2017 RACT submittal also contains a table (see
Appendix A: Control Technique Guidelines and Alternative Control
Techniques Documents) listing all the CTG and ACT categories and the
corresponding State regulations or negative declarations that address
the requirements. The EPA previously approved and incorporated into the
SIP the State's regulations identified in Appendix A that address ACTs
and CTGs.
    For some source categories, the SIP-approved New York rules have
more stringent emission limits and/or lower thresholds of applicability
than the recommendations contained in the CTG and ACT documents. In its
submittal, New York identified categories where controls may be more
stringent than the recommended levels contained in the CTG and ACT
documents. For example, Part 228, ``Surface Coating Processes,
Commercial and Industrial Adhesives, Sealants and Primers,'' Part 234,
``Graphic Arts,'' Part 241, ``Asphalt Pavement and Asphalt Based
Surface Coatings,'' and Part 227-2, ``Reasonably Available Control
Technology (RACT) for Major Facilities of Oxides of Nitrogen
(NOX)'' have each been adopted by the State with more
stringent limits or applicability than what was recommended by the
corresponding CTG or ACT. New York certifies that its SIP-approved
regulations meet the RACT requirements for the New York portion of NYMA
moderate nonattainment area for the 2008 8-hour ozone standard.

Solvent Cleaning Processes

    On November 5, 2019, the State submitted a revised 6 NYCRR Part
226, ``Solvent Cleaning Processes and Industrial Cleaning Solvents.''
The prior 6 NYCRR 226 has been re-numbered as 6 NYCRR Subpart 226-1 and
renamed ``Solvent Cleaning Processes'' from ``Solvent Metal Cleaning
Processes'' to accommodate the addition of a new rule, 6 NYCRR 226-2,
``Industrial Cleaning Solvents.'' Attendant changes have been made to 6
NYCRR 201, ``Permit and Certificates,'' and those will be reviewed for
potential rule making action in the future.

Solvent Cleaning Processes 6 NYCRR 226-1

    Subpart 226-1 applies to all owners or operators of facilities who
operate cold cleaners (including remote reservoir cold cleaning
machines), open-top vapor degreasers, and all types of conveyorized
degreasers that carry out solvent cleaning processes of metal objects
using a solution containing VOCs. After December 1, 2020, Subpart 226-1
expands applicability to include such cleaning of non-metal objects.
Subpart 226-1 also changes the current cold cleaning requirement of
using a solvent with a maximum vapor pressure of 1.0 mm Hg, or less, at
20 degrees Celsius, to using a cleaner with no more than twenty-five
(25) grams of VOC per liter (25g/l) of cleaning solution. These
revisions, and the inclusion of non-metal objects, make the proposed
regulation more stringent than the previously approved regulation.

CTG for Industrial Cleaning Solvents

    In New York's December 2014 state-wide RACT submittal, as
supplemented on September 6, 2017, the State committed to revise 6
NYCRR Part 226, ``Solvent Metal Cleaning Processes,'' and to fulfill
that requirement by no later than November 30, 2018. On November 5,
2019, New York submitted the revised 6 NYCRR Part 226 for inclusion
into the SIP to address requirements regarding the CTG for industrial
cleaning solvents that were identified in the EPA's conditional
approval. 82 FR 58342 (December 12, 2017).
    The EPA issued a CTG for industrial cleaning solvents in 2006. This
category includes the industrial cleaning solvents used by many
industries to remove contaminants such as adhesives, inks, paint, dirt,
soil, oil and grease. The recommended measures for controlling VOC
emissions from the use, storage and disposal of industrial cleaning
solvents include work practice standards, limitations on VOC content of
the cleaning materials, and an optional alternative limit on composite
vapor pressure of the cleaning materials. They also include the use of
add-on controls with an overall emission reduction of at least 85
percent by mass.
    Based on the EPA's CTG, New York revised 6 NYCRR Part 226,
``Solvent

Metal Cleaning Processes,'' and added a new Subpart, Subpart 226-2
``Industrial Cleaning Solvents'' which specifies VOC content and vapor
pressure limits for solvents used in solvent cleaning of foreign
materials from surfaces of unit operations such as large and small
manufactured components, parts, equipment, floors, tanks, and vessels.
The facility applicability threshold is in line with the CTG, actual
emissions of (3) tons per year or more of VOC's from industrial
cleaning solvents on a 12-month rolling total basis. Compliance is
achieved by implementing the listed work practices and meeting a
maximum VOC content, or a maximum VOC composite vapor pressure.
Recordkeeping must be maintained which demonstrates compliance. The EPA
proposes to find that New York's adopted industrial cleaning solvents
rule is as effective in regulating the source category as the EPA's CTG
document. Therefore, the EPA is proposing to approve the revisions to 6
NYCRR Part 226, ``Solvent Cleaning Processes and Industrial Cleaning
Solvents'' which includes Subpart 226-2 ``Industrial Cleaning
Solvents.''

Source Categories Not Applicable in New York State

    In New York's November 2017 RACT SIP for the New York portion of
NYMA, the State certified that there are no sources in New York State
(and therefore the New York portion of the NYMA) for six CTGs. This
certification results from a review of the State's emission inventory
and emission statements. The CTGs for which the negative declaration
applies are as follows: Manufacture of Vegetable Oils; Manufacture of
High-Density Polyethylene, Polypropylene and Polystyrene Resins;
Natural Gas/Gasoline Processing Plants; Air Oxidation Processes in
Synthetic Organic Chemical Manufacturing Industry; Fiberglass Boat
Manufacturing Materials; Agricultural Pesticides. In New York's
December 2014 statewide RACT SIP, the State also certified that there
were no sources in the State for these same six CTGs. New York
previously certified to the satisfaction of the EPA (40 CFR 52.1683(a)
and (b)) that there are no sources for these six CTGs in New York State
(and therefore the New York portion of the NYMA). The EPA is not
proposing any action on this certification since we previously approved
the State's negative declaration for these six CTGs. See December 12,
2017 (82 FR 58342) and 40 CFR 52.1683(a) and (b).

Source-Specific RACT Determinations

    The 8-hour ozone RACT analysis must address source-specific RACT as
it applies to a single regulated entity. A source-specific RACT
determination applies to sources that have obtained a facility-specific
emission limit or an alternative emission limit, i.e., a variance. A
case-by-case RACT analysis is required for sources that are not defined
by a specific source category covered by an existing state regulation,
that are requesting a variance, or that are not addressed by a CTG. New
York's RACT guidance entitled, ``DAR-20 Economic and Technical Analysis
for Reasonably Available Control Technology (RACT)'' outlines the
process and conditions for granting source-specific RACT
determinations. Under the CAA, these individual source-specific RACT
determinations need to be submitted by the State as a SIP revision for
the EPA's approval. Therefore, New York included in Appendix B of its
November 2017 RACT SIP submittal a listing of VOC and NOX
source facilities that are subject to a RACT source-specific SIP
revision under the 8-hour ozone SIP and corresponding emission limits,
technology and the applicable regulation governing the RACT
determinations. In September 2008, August 2010, December 2013, and
August 2015, New York submitted to the EPA SIP revisions that included
most of the source-specific RACT revisions identified in Appendix B of
the RACT SIP submittals. The EPA is performing its technical review of
those submittals and will take separate rulemaking actions for each of
the source-specific determinations.
    In addition, in accordance with New York's NOX RACT
regulation, Part 227-2, owners of combined cycle combustion turbines
are required to perform case-by-case RACT determinations that may
result in more stringent emission limits. This RACT requirement was
approved into the SIP. 78 FR 41846 (July 12, 2013).

Additional Control Measures Needed for Attainment

    In New York's December 22, 2014 state-wide RACT SIP submittal,
included in the docket for this action, the State's response to
comments stated that ``once the NYMA is reclassified as `moderate'
nonattainment for the 2008 ozone NAAQS and an attainment SIP is
required, DEC [New York] will undertake a review of its many
NOX control options to determine which would most
efficiently and effectively reduce emission in the New York portion of
NYMA.''
    As part of the State's November 13, 2017 SIP submittal, New York
has included an attainment demonstration for the New York portion of
NYMA moderate nonattainment area for the 2008 ozone NAAQS. In the
State's November 2017 SIP submittal letter, New York stated that the
NYMA is unable to reach attainment of the 2008 ozone NAAQS by the
statutory deadline of July 20, 2018. The State requested that the EPA
issue an expeditious reclassification to serious nonattainment so that
New York, New Jersey, and Connecticut have adequate time to develop
complete SIPs that forecast attainment in the NYMA by the serious area
deadline of July 20, 2021. On August 23, 2019 (84 FR 44238), the EPA
announced, among other things, the reclassification of the NYMA from a
moderate nonattainment area a serious nonattainment area.\10\ The NYMA
serious nonattainment area must attain the standards by July 20, 2021.
---------------------------------------------------------------------------

    \10\ On August 23, 2019, the EPA published a document in the
Federal Register (84 FR 44238) finalizing the reclassification of
the New York-North New Jersey-Long Island, New York-New Jersey-
Connecticut nonattainment area from moderate to serious.
---------------------------------------------------------------------------

    As stated in our final action on New York's December 2014 state-
wide RACT SIP, published December 12, 2017 (82 FR 58342), New York
could quantify potential reductions for the following NOX
control options. It should be noted that New York has initiated the
regulatory process toward adoption of regulations for some of the
source categories addressed in the December 2017 final rule including
lowering NOX or VOC emissions standards for Municipal Waste
Combustors, Simple Cycle Combustion Turbines operating as ``peakers,''
and Distributed Generators. The State's September 2018 SIP submittal
\11\ addressing interstate transport confirms that New York has
progressed, in various stages of the rulemaking process, toward
regulating these sources, as well as other source categories emitting
either NOX or VOCs. EPA encourages New York to finalize
these additional regulations and to explain why they are or are not
considered RACT based on economic and technological feasibility.
---------------------------------------------------------------------------

    \11\ See page 3 at https://www.dec.ny.gov/docs/air_pdf/sipprop2008o3trans.pdf.
---------------------------------------------------------------------------

    In addition, considering that in November 2017 New York requested
that EPA reclassify the NYMA from moderate to serious nonattainment for
the 2008 ozone standard, EPA strongly encourages New York to adopt new
regulations for controlling NOX

emissions at least as stringent as those adopted in the states of
Connecticut and New Jersey for municipal waste combustors, simple cycle
combustion turbines (``peakers'') operating during high electric demand
days (HEDD), and distributed generators. Adoption of such regulations
would provide additional NOX reductions that will help
attain the 2008 ozone standard in the NYMA. Further details are
discussed in the following sections.

Municipal Waste Combustors

    During the public comment period on New York's 2008 ozone RACT
proposal a comment was submitted to the State proposing that Municipal
Waste Combustors (MWCs) in the New York portion of NYMA should be
controlled to at least the RACT level. In its response to the comment,
New York estimated that potential NOX reductions of 1.50 and
1.75 tons per day could be obtained from MWCs located in the New York
portion of NYMA. In New York's response, the State also indicated that
once the NYMA is classified as moderate the State would undertake a
review of its many control options to determine which would most
effectively and efficiently reduce emissions in the New York portion of
NYMA.
    As stated previously, the NYMA was reclassified as a moderate
nonattainment area effective June 2016. New York's neighboring states
of New Jersey and Connecticut have adopted NOX emission
limits for MWCs that are more stringent than New York's current
permitted limits. The EPA has approved New Jersey's and Connecticut's
revised NOX limits into the SIP.\12\ The SIP approved
NOX limit for MWCs in New Jersey and Connecticut \13\ is 150
parts per million (ppmvd).\14\ New York regulates MWCs under Part 219
(Incinerators) and Part 200 (General Provisions). EPA notes that on
September 25, 2019, New York announced proposed changes to 6 NYCRR
Subpart 219, ``Incinerators,'' which, among other things, would limit
oxides of nitrogen emissions from municipal waste combustion units.\15\
Inclusion in the SIP of more stringent NOX emission limits
for MWCs located in the New York portion of NYMA would provide
additional NOX reductions to help attain the 2008 ozone
NAAQS.
---------------------------------------------------------------------------

    \12\ For New Jersey, see 75 FR 80340 (December 22, 2010); for
Connecticut, see 82 FR 35454 (July 31, 2017).
    \13\ In Connecticut, the 150 ppmvd limit is for ``mass burn
waterwall combustors.''
    \14\ As measured on a dry volume basis and corrected to 7%
oxygen.
    \15\ On September 25, 2019, New York announced a proposed rule,
6 NYCRR Subpart 219, ``Incinerators.'' The proposed rule is to limit
oxides of nitrogen emissions from municipal waste combustion units.
The public comment period ended on December 11, 2019.
---------------------------------------------------------------------------

Simple Cycle Combustion Turbines (Firing Distillate Oil or More Than
One Fuel)--Also Called ``Peakers''

    New York's NOX RACT regulation at Part 227-2 established
NOX emission limits of 100 ppmvd \16\ for simple cycle
combustion turbines firing distillate oil or more than one fuel. New
York's neighboring state of Connecticut \17\ has adopted more stringent
NOX emission limits of 50-75 ppm with a compliance date of
June 2018 and 40-50 ppm with a compliance date of June 2023 for this
source category. New Jersey has also adopted more stringent
NOX emission limits of 42 ppm.\18\ On December 31, 2019, New
York announced an approved rule, 6 NYCRR Subpart 227-3, ``Ozone Season
Oxides of Nitrogen (NOX) Emission Limits for Simple Cycle
and Regenerative Combustion Turbines.'' \19\ Many of the units
addressed by New York's approved rule are peaking units located in the
New York portion of NYMA; these units generally have either no or low-
level NOX emission controls and typically operate during
periods of elevated temperature when electric demand increases, and
ozone nonattainment areas see ozone levels rise to unhealthy levels.
The EPA will fully assess New York's recently adopted Subpart 227-3 for
approvability once the rule is submitted to EPA for inclusion into the
New York SIP. Inclusion into the SIP of more stringent NOX
emission limits for simple cycle turbines located throughout the State,
and particularly in the New York portion of NYMA, would provide
additional NOX reductions to help attain the 2008 ozone
NAAQS.
---------------------------------------------------------------------------

    \16\ Corrected to 15% oxygen.
    \17\ For Connecticut, see 82 FR 35454 (July 31, 2017).
    \18\ 42 ppm is equivalent to 1.6 lb/megawatt-hour which is the
limit at Table 7 of New Jersey's NOX RACT regulation,
Subchapter 19. Subchapter 19 at Table 7 notes that the limit is
applicable to high electric demand day (HEDD) units or a stationary
combustion turbine that is capable of generating 15 MW or more and
that commenced operation on or after May 1, 2005. In accordance with
Subchapter 19 definitions, units that commence operation on or after
May 1, 2005 are neither HEDD nor non-HEDD units.
    \19\ On December 31, 2019, New York announced an approved rule,
6 NYCRR Subpart 227-3, ``Ozone Season Oxides of Nitrogen
(NOX) Emission Limits for Simple Cycle and Regenerative
Combustion Turbines.'' These controls are for ``peaking'' combustion
turbines operating on high electric demand days. See https://www.dos.ny.gov/info/register/2019/dec31.pdf.
---------------------------------------------------------------------------

NYCRR Part 222 for Distributed Generation (DG)

    New York has undertaken the regulatory process to adopt 6 NYCRR
Part 222 for DG to address NOX emissions from electric
generating units during high electric demand days. New York's
neighboring states of Connecticut and New Jersey have adopted
regulations \20\ for controlling NOX emissions from DG
sources, and New Jersey's DG provisions are approved into the SIP. EPA
encourages New York to submit Part 222 as a SIP revision \21\ for EPA
approval as soon as possible after completion of the regulatory
process.
---------------------------------------------------------------------------

    \20\ For Connecticut see DG regulation at 22a-174-42; For New
Jersey see Subchapter 19 at section 19.8(e)(1), (2) and (4). The EPA
approved Subchapter 19 on December 22, 2010 (75 FR 80340).
    \21\ On September 4, 2019, New York announced a proposed rule, 6
NYCRR Subpart 222, ``Distributed Generation Sources.'' The proposed
rule is to replace the rule adopted on November 1, 2016. The new
rule would apply to demand response and price-responsive generation
sources located in the NYC metropolitan area. The public comment
period ended on November 25, 2019.
---------------------------------------------------------------------------

Other New York Certifications

    As part of New York's 2008 ozone attainment demonstration for the
New York portion of NYMA moderate nonattainment area the State has
certified that the following previously-approved SIP elements remain
adequate, and no revisions to the state plan are necessary.

State-Wide Nonattainment New Source Review (NNSR)

    New York affirms in its November 2017 RACT submittal that, since
the State is located entirely in the OTR, regardless of the area's
designation status, NNSR applies state-wide for emissions of ozone
precursor pollutants, VOC and NOX, for new major facilities
or modifications to existing major or minor sources. New major
facilities or modification to existing major or minor facilities in New
York State are subject to the provisions of 6 NYCRR Part 231,\22\ ``New
Source Review for New and Modified Facilities.'' Major-source pollutant
thresholds are lower in the NYMA, however, due to the area's former
severe classification under the 1-hour ozone NAAQS: 25 Tons per year
for VOC or NOX, as opposed to 50 to 100 tons, respectively,
throughout the rest of the state. The NYMA also has a lower significant
source project threshold and significant net emission increase
threshold, as well as a more stringent offset ratio for both
precursors.
---------------------------------------------------------------------------

    \22\ The EPA approved Part 231 on December 27, 2016 (81 FR
95049).
---------------------------------------------------------------------------

    NNSR requires the application of Lowest Achievable Emission Rate

(LAER) which is more stringent than RACT. Furthermore, New York
certifies in its November 2017 submittal that the State also relies
upon federal rules such as the National Emission Standards for
Hazardous Air Pollutants (NESHAPs) regulated under CAA section 112.
NESHAPs establish MACT which may be more stringent than RACT to control
hazardous air pollutants.
    The EPA is proposing to approve New York's certification that NNSR
applies state-wide for NOX and VOC emissions from stationary
sources and fully meets the requirements of the CAA for the 2008 8-hour
ozone NAAQS.

Vehicle Inspection and Maintenance (I/M)

    New York certifies that it has implemented an approved state-wide,
enhanced motor vehicle I/M program under 6 NYCRR Part 217-6 and 15
NYCRR Part 79 to limit ozone precursor emissions from motor
vehicles.\23\ The current New York Vehicle Inspection Program (NYVIP2)
requires an appropriate emissions inspection (e.g., onboard diagnostic
(OBDII) or low enhanced inspection) for most vehicles annually and with
changes of vehicle ownership. The emissions inspection is determined by
vehicle motor year, gross vehicle weight rating (GVWR), fuel type, and
registration class.
---------------------------------------------------------------------------

    \23\ The EPA approved NYCRR Part 217-6 and 15 NYCRR Part 79 on
February 28, 2012 (77 FR 11742).
---------------------------------------------------------------------------

    Therefore, the EPA is proposing to approve New York's certification
that the previously-approved SIP element for the State's enhanced
vehicle I/M program remain adequate and fully meet the requirements of
the CAA for moderate classification of the 2008 8-hour ozone NAAQS.

Emission Statements

    New York certifies that the emission statement requirement of CAA
section 182(a)(3)(b) is fully addressed through 6 NYCRR Subpart 202-2
\24\ that is applicable state-wide. Therefore, the EPA is proposing to
approve New York's emission statement certification that the
previously-approved SIP element fully meets the requirements of the CAA
for moderate classification of the 2008 8-hour ozone NAAQS.
---------------------------------------------------------------------------

    \24\ The EPA approved 6 NYCRR Subpart 202-2 on October 31, 2007
(72 FR 61530).
---------------------------------------------------------------------------

Other New York Certifications

    New York certifies that NOX and VOC RACT requirements,
which are discussed elsewhere in this proposal, are fully addressed.
New York also certifies that the State's Emission Inventory
requirements are fully addressed through the submission of the 2011
baseline inventory. The EPA is not taking action on the Emissions
Inventory certification at the current time but will do so in the
future.

IV. What is the EPA's evaluation of New York's SIP submittal?

    New York submitted a RACT assessment and an attainment
demonstration the 2008 ozone moderate nonattainment standard for the
New York portion of NYMA and for New York State as part of the OTR.
    The EPA is proposing to approve New York's state-wide RACT
submittal dated December 22, 2014, as supplemented on September 6, 2017
and November 5, 2019, for purposes of satisfying the 2008 8-hour ozone
standard RACT requirement, as it applies to CTG requirements for
sources of VOC, including industrial cleaning solvents. The EPA is
proposing to approve the revisions to 6 NYCRR Part 226, ``Solvent
Cleaning Processes and Industrial Cleaning Solvents,'' with a State
effective date of November 1, 2019.
    The EPA is proposing to approve New York's November 13, 2017 SIP
submittal as it applies to non-CTG major sources of VOCs, all CTG
sources of VOCs, other than the 2016 oil and natural gas CTG, and to
major sources of NOX.
    The EPA is also proposing to approve New York's state-wide
certifications applicable to the New York portion of NYMA moderate
nonattainment area for: (1) Nonattainment new source review; (2)
vehicle I/M program; and (3) emission statements.
    The EPA is soliciting public comments on the issues discussed in
this proposal. These comments will be considered before the EPA takes
final action. Interested parties may participate in the federal
rulemaking procedure by submitting written comments as discussed in the
ADDRESSES section of this rulemaking.

V. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the CAA 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 proposes to approve state law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by state law. For that reason, this proposed action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993), and 13563 (76 FR 382, January 21,
2011);
     Is not an Executive Order 13771 (82 FR 9339, February 2,
2017) regulatory action because SIP approvals are exempt under
Executive Order 12866;
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this proposed rulemaking action, pertaining to New
York's 2008 8-hour ozone RACT submission, 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 any substantial direct costs on tribal governments or preempt
tribal law as specified by Executive Order 13175 (65 FR 67249, November
9, 2000).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Nitrogen dioxide, Ozone,
Reporting and recordkeeping requirements, Volatile organic compounds.

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

    Dated: January 28, 2020.
Peter D. Lopez,
Regional Administrator, Region 2.
[FR Doc. 2020-02819 Filed 2-12-20; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 88, Number 67 (Friday, April 7, 2023)]
[Rules and Regulations]
[Pages 20743-20746]
[FR Doc No: 2023-07093]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2022-1648; Project Identifier MCAI-2022-00894-T;
Amendment 39-22357; AD 2023-04-10]
RIN 2120-AA64

Airworthiness Directives; Dassault Aviation Airplanes

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

ACTION: Final rule.

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

SUMMARY: The FAA is superseding Airworthiness Directive (AD) 2020-26-
07, which applied to all Dassault Aviation Model MYSTERE-FALCON 900
airplanes. AD 2020-26-07 required revising the existing maintenance or
inspection program, as applicable, to incorporate new or more
restrictive airworthiness limitations. This AD was prompted by a
determination that a new airworthiness limitation is necessary. This AD
continues to require the actions in AD 2020-26-07, and also requires
revising the existing maintenance or inspection program, as applicable,
to incorporate a new airworthiness limitation; as specified in a
European Union Aviation Safety Agency (EASA) AD, which is incorporated
by reference. The FAA is issuing this AD to address the unsafe
condition on these products.

DATES: This AD is effective May 12, 2023.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of May 12,
2023.
    The Director of the Federal Register approved the incorporation by
reference of a certain other publication listed in this AD as of
January 25, 2021 (85 FR 82901, December 21, 2020).

ADDRESSES:
    AD Docket: You may examine the AD docket at regulations.gov under
Docket No. FAA-2022-1648; 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 final rule, the mandatory continuing airworthiness
information (MCAI), any comments received, and other information. The
address for Docket Operations is U.S. Department of Transportation,
Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200
New Jersey Avenue SE, Washington, DC 20590.
    Material Incorporated by Reference:
     For material incorporated by reference in this AD, contact
EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone +49 221
8999 000; email [email protected]; website easa.europa.eu. You may
find this material on the EASA website at ad.easa.europa.eu.
     You may view this material at the FAA, Airworthiness
Products Section, Operational Safety Branch, 2200 South 216th St., Des
Moines, WA. For information on the availability of this material at the
FAA, call<PHONE_NUMBER>. It is also available in the AD docket at
regulations.gov under Docket No. FAA-2022-1648.

FOR FURTHER INFORMATION CONTACT: Tom Rodriguez, Aerospace Engineer,
Large Aircraft Section, FAA, International Validation Branch, 2200
South 216th St., Des Moines, WA 98198; telephone<PHONE_NUMBER>; email
[email protected].

SUPPLEMENTARY INFORMATION:

Background

    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 to supersede AD 2020-06-07, Amendment 39-21362 (85 FR
82901, December 21, 2020) (AD 2020-06-07). AD 2020-06-07 applied to all
Dassault Aviation Model MYSTERE-FALCON 900 airplanes. AD 2020-06-07
required revising the existing maintenance or inspection program, as
applicable, to incorporate new or more restrictive airworthiness
limitations. The FAA issued AD 2020-06-07 to address reduced structural
integrity of the airplane. AD 2020-26-07 also specified that
accomplishing the revision required by that AD terminated certain
requirements of AD 2010-26-05, Amendment 39-16544 (75 FR 79952,
December 21, 2010) (AD 2010-26-05).
    The NPRM published in the Federal Register on December 16, 2022 (87
FR 77037). The NPRM was prompted by AD 2022-0137, dated July 6, 2022,
issued by EASA (EASA AD 2022-0137) (also referred to as the MCAI). The
MCAI states that since issuance of EASA AD 2020-0115, dated May 20,
2020 (EASA AD 2020-0115), a new maintenance task for eddy current
inspections of the flap tracks 2 and 5 has been introduced.
    You may examine the MCAI in the AD docket at regulations.gov under
Docket No. FAA-2022-1648.
    In the NPRM, the FAA proposed to continue to require revising the
existing maintenance or inspection program, as applicable to
incorporate new or more restrictive airworthiness limitations, as
specified in EASA AD 2010-0115. The NPRM also proposed to require
revising the existing maintenance or inspection program, as applicable,
to incorporate a new airworthiness limitation, as specified in EASA AD
2022-0137. The FAA is issuing this AD to address reduced structural
integrity of the airplane.

Discussion of Final Airworthiness Directive

Comments

    The FAA received no comments on the NPRM or on the determination of
the cost to the public.

Conclusion

    This product has been approved by the aviation authority of another
country and is approved for operation in the United States. Pursuant to
the FAA's bilateral agreement with this State of Design Authority, it
has notified the FAA of the unsafe condition described in the MCAI
referenced above. The FAA reviewed the relevant data and determined
that air safety requires adopting this AD as proposed. Accordingly, the
FAA is issuing this AD to address the unsafe condition on this product.
Except for minor editorial changes, this AD is adopted as proposed in
the NPRM. None of the changes will increase the economic burden on any
operator.

Related Service Information Under 1 CFR Part 51

    EASA AD 2022-0137 specifies a new airworthiness limitation for eddy
current inspections of the flap tracks 2 and 5.
    This AD also requires EASA 2020-0115, which the Director of the
Federal Register approved for incorporation by reference as of January
25, 2021 (85 FR 82901, December 21, 2020).
    This material 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.

Costs of Compliance

    The FAA estimates that this AD affects 151 airplanes of U.S.
registry. The FAA estimates the following costs to comply with this AD:
    The FAA estimates the total cost per operator for the retained
actions from AD 2020-26-07 to be $7,650 (90 work-hours x $85 per work-
hour).
    The FAA has determined that revising the existing maintenance or
inspection program takes an average of 90 work-hours per operator,
although the agency recognizes that this number may vary from operator
to operator. Since operators incorporate maintenance or inspection
program changes for their affected fleet(s), the FAA has determined
that a per-operator estimate is more accurate than a per-airplane
estimate.
    The FAA estimates the total cost per operator for the new actions
to be $7,650 (90 work-hours x $85 per work-hour).

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.

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government.
    For the reasons discussed above, I certify that this AD:
    (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 Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by:
0
a. Removing Airworthiness Directive 2020-06-07, Amendment 39-21362 (85
FR 82901, December 21, 2020); and
0
b. Adding the following new airworthiness directive:

2023-04-10 Dassault Aviation: Amendment 39-22357; Docket No. FAA-
2022-1648; Project Identifier MCAI-2022-00894-T.

(a) Effective Date

    This airworthiness directive (AD) is effective May 12, 2023.

(b) Affected ADs

    (1) This AD replaces AD 2020-26-07, Amendment 39-21362 (85 FR
82901, December 21, 2020) (AD 2020-26-07).

    (2) This AD affects AD 2010-26-05, Amendment 39-16544 (75 FR
79952, December 21, 2010) (AD 2010-26-05).

(c) Applicability

    This AD applies to all Dassault Aviation Model MYSTERE-FALCON
900 airplanes, certificated in any category.

(d) Subject

    Air Transport Association (ATA) of America Code 05, Time Limits/
Maintenance Checks.

(e) Unsafe Condition

    This AD was prompted by a determination that new airworthiness
limitations are necessary. The FAA is issuing this AD to address
reduced structural integrity of the airplane.

(f) Compliance

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

(g) Retained Revision of the Existing Maintenance or Inspection
Program, With No Changes

    This paragraph restates the requirements of paragraph (i) of AD
2020-26-07, with no changes. Except as specified in paragraph (h) of
this AD: Comply with all required actions and compliance times
specified in, and in accordance with, European Union Aviation Safety
Agency (EASA) AD 2020-0115, dated May 20, 2020 (EASA AD 2020-0115).
Accomplishing the revision of the existing maintenance or inspection
program required by paragraph (j) of this AD terminates the
requirements of this paragraph.

(h) Retained Exceptions to EASA AD 2020-0115, With No Changes

    This paragraph restates the exceptions specified in paragraph
(j) of AD 2020-26-07, with no changes.
    (1) The requirements specified in paragraphs (1) and (2) of EASA
AD 2020-0115 do not apply to this AD.
    (2) Paragraph (3) of EASA AD 2020-0115 specifies revising ``the
approved AMP'' within 12 months after its effective date, but this
AD requires revising the existing maintenance or inspection program,
as applicable, to incorporate the ``limitations, tasks and
associated thresholds and intervals'' specified in paragraph (3) of
EASA AD 2020-0115 within 90 days after January 25, 2021 (the
effective date of AD 2020-26-07).
    (3) The initial compliance time for doing the tasks specified in
paragraph (3) of EASA AD 2020-0115 is at the applicable ``associated
thresholds'' specified in paragraph (3) of EASA AD 2020-0115, or
within 90 days after January 25, 2021 (the effective date of AD
2020-26-07), whichever occurs later.
    (4) The provisions specified in paragraphs (4) and (5) of EASA
AD 2020-0115 do not apply to this AD.
    (5) The ``Remarks'' section of EASA AD 2020-0115 does not apply
to this AD.

(i) Retained Restrictions on Alternative Actions or Intervals, With a
New Exception

    This paragraph restates the requirements of paragraph (k) of AD
2020-26-07, with a new exception. Except as required by paragraph
(j) of this AD, after the maintenance or inspection program has been
revised as required by paragraph (g) of this AD, no alternative
actions (e.g., inspections) or intervals are allowed unless they are
approved as specified in the provisions of the ``Ref. Publications''
section of EASA AD 2020-0115.

(j) New Revision of the Existing Maintenance or Inspection Program

    Except as specified in paragraph (k) of this AD: Comply with all
required actions and compliance times specified in, and in
accordance with, EASA AD 2022-0137, dated July 6, 2022 (EASA AD
2022-0137). Accomplishing the revision of the existing maintenance
or inspection program required by this paragraph terminates the
requirements of paragraph (g) of this AD.

(k) Exceptions to EASA AD 2022-0137

    (1) This AD does not adopt the requirements specified in
paragraphs (1) and (2) of EASA AD 2022-0137.
    (2) Paragraph (3) of EASA AD 2022-0137 specifies revising ``the
approved AMP'' within 12 months after its effective date, but this
AD requires revising the existing maintenance or inspection program,
as applicable, within 90 days after the effective date of this AD.
    (3) The initial compliance time for doing the tasks specified in
paragraph (3) of EASA AD 2022-0137 is at the applicable
``limitations'' and ``associated thresholds'' as incorporated by the
requirements of paragraph (3) of EASA AD 2022-0137, or within 90
days after the effective date of this AD, whichever occurs later.
    (4) This AD does not adopt the provisions specified in
paragraphs (4) and (5) of EASA AD 2022-0137.
    (5) This AD does not adopt the ``Remarks'' section of EASA AD
2022-0137.

(l) New Provisions for Alternative Actions and Intervals

    After the existing maintenance or inspection program has been
revised as required by paragraph (j) of this AD, no alternative
actions (e.g., inspections) and intervals are allowed unless they
are approved as specified in the provisions of the ``Ref.
Publications'' section of EASA AD 2022-0137.

(m) Terminating Actions for Certain Requirements in AD 2010-26-05

    Accomplishing the actions required by paragraph (g) or (j) of
this AD terminates the requirements of paragraph (g)(1) of AD 2010-
26-05, for Dassault Aviation Model MYSTERE-FALCON 900 airplanes
only.

(n) Additional AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Validation 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 responsible Flight Standards Office, as
appropriate. If sending information directly to the International
Validation Branch, send it to the attention of the person identified
in paragraph (o) of this AD. Information may be emailed to: [email protected]. Before using any approved AMOC, notify your
appropriate principal inspector, or lacking a principal inspector,
the manager of the responsible Flight Standards Office.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain instructions from a manufacturer, the instructions must be
accomplished using a method approved by the Manager, International
Validation Branch, FAA; or EASA; or Dassault Aviation's EASA Design
Organization Approval (DOA). If approved by the DOA, the approval
must include the DOA-authorized signature.

(o) Additional Information

    For more information about this AD, contact Tom Rodriguez,
Aerospace Engineer, Large Aircraft Section, FAA, International
Validation Branch, 2200 South 216th St., Des Moines, WA 98198;
telephone<PHONE_NUMBER>; email [email protected].

(p) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (3) The following service information was approved for IBR on
May 12, 2023.
    (i) European Union Aviation Safety Agency (EASA) AD 2022-0137,
dated July 6, 2022.
    (ii) [Reserved]
    (4) The following service information was approved for IBR on
January 25, 2021 (85 FR 82901, December 21, 2020).
    (i) European Union Aviation Safety Agency (EASA) AD 2020-0115,
dated May 20, 2020.
    (ii) [Reserved]
    (5) For EASA ADs 2022-0137 and 2020-0115, contact EASA, Konrad-
Adenauer-Ufer 3, 50668 Cologne, Germany; telephone +49 221 8999 000;
email [email protected]; website easa.europa.eu. You may find this
EASA AD on the EASA website at ad.easa.europa.eu.
    (6) You may view this material at the FAA, Airworthiness
Products Section, Operational Safety Branch, 2200 South 216th St.,
Des Moines, WA. For information on the availability of this material
at the FAA, call<PHONE_NUMBER>.
    (7) You may view this material that is incorporated by reference
at the National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, email
[email protected], or go to: www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on February 17, 2023.
Christina Underwood,
Acting Director, Compliance & Airworthiness Division, Aircraft
Certification Service. Compliance & Airworthiness Division, Aircraft
Certification Service.
[FR Doc. 2023-07093 Filed 4-6-23; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: January 15, 2010 (Volume 75, Number 10)]
[Rules and Regulations]
[Page 2438-2440]
[DOCID:fr15ja10-5]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2009-1060]
RIN 1625-AA00

Safety Zone; Havasu Landing Annual Regatta; Colorado River, Lake
Havasu Landing, CA

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary safety zone on
Lake Havasu, California in support of the Havasu Landing Annual
Regatta. This temporary safety zone is necessary to provide for the
safety of the participants, crew, spectators, participating vessels,
and other vessels and users of the waterway. Persons and vessels are
prohibited from entering into, transiting through, or anchoring within
this safety zone unless authorized by the Captain of the Port, or his
designated representative.

DATES: This rule is effective from 8 a.m. until 4 p.m., on January 16
and 17, 2010.

ADDRESSES: Documents indicated in this preamble as being available in
the docket are part of docket USCG-2009-1060 and are available online
by going to http://www.regulations.gov, inserting USCG-2009-1060 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
temporary rule, call or e-mail Petty Officer Corey McDonald, Waterways
Management, U.S. Coast Guard Sector San Diego, Coast Guard; telephone
619-278-7262, 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:

Regulatory Information

    The Coast Guard is issuing this temporary final rule without prior
notice and opportunity to comment pursuant to authority under section
4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because it was impracticable since the
logistical details of the race were not finalized nor presented to the
Coast Guard in enough time to draft and publish an NPRM. As such, the
event would occur before the rulemaking process was complete and
immediate action is needed to ensure public safety and ensure non-
authorized personnel and vessels remain safe by keeping clear of the
hazardous area during the regatta activities.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Delaying the effective date would
be contrary to the public interest, since immediate action is needed to
ensure public safety.

Background and Purpose

    This temporary safety zone is established in support of the Havasu
Landing Annual Regatta, a marine event that includes participating
vessels along an established and marked course on Lake Havasu, CA. This
temporary safety zone is necessary to provide for the safety of the
crews, spectators, and participants of the race and is also necessary
to protect other vessels and users of the waterway.

Discussion of Rule

    The Coast Guard is establishing a safety zone that will be enforced
from 8 a.m. to 4 p.m. on Saturday January 16, and Sunday January 17,
2010. The limits of this safety zone are as follows: From the
California shoreline in position 34[deg]29.40[min] N 114[deg]24.12[min]
W to the northern corner 900 yards east in position 34[deg]29.40[min] N
114[deg]23.39[min] W to the southern corner 1400 yards south in
position 34[deg]29.0[min] N 114[deg]23.39[min] W to the California
shoreline in position 34[deg]29.0[min] N 114[deg]24.12[min] W.
    This safety zone is necessary to ensure non-authorized personnel
and vessels remain safe by keeping clear of the hazardous area during
the training activities. Persons and vessels are prohibited from
entering into, transiting through, or anchoring within this safety zone
unless authorized by the Captain of the Port, or his designated
representative.

Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking. Below we summarize our analyses
based on 13 of these statutes or executive orders.

Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, and does not
require an assessment of potential costs and benefits under section
6(a)(3) of that Order. The Office of Management and Budget has not
reviewed it under that Order. The safety zone is of a limited duration,
only eight hours per day for a period of two days, and is limited to a
relatively small geographic area.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this rule would have a significant economic impact
on a substantial number of small entities. The term ``small entities''
comprises small businesses, not-for-profit organizations that are
independently owned and operated and are not dominant in their fields,
and governmental jurisdictions with populations of less than 50,000.
    The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will
not have a significant economic impact on a substantial number of small
entities. The safety zone will affect the following entities some of
which may be small entities: The owners and operators of pleasure craft
engaged in recreational activities and sightseeing. This safety zone
will not have a significant economic impact on a substantial number of
small entities for several reasons: Vessel traffic can pass safely
around the area, vessels engaged in recreational activities have ample
space outside of the safety zone to engage in these activities, and
this safety zone is limited in scope and duration as it is only in
effect for eight hours per day for a period of two days.

Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we offer to assist small
entities in understanding the rule so that they can better evaluate its
effects on them and participate in the rulemaking process.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

Collection of Information

    This rule calls for no new collection of information under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on State or local
governments and would either preempt State law or impose a substantial
direct cost of compliance on them. We have analyzed this rule under
that Order and have determined that it does not have implications for
federalism.

Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or Tribal government, in
the aggregate, or by the private sector of $100,000,000 or more in any
one year. Though this rule will not result in such an expenditure, we
do discuss the effects of this rule elsewhere in this preamble.

Taking of Private Property

    This rule will not effect a taking of private property or otherwise
have taking implications under Executive Order 12630, Governmental
Actions and Interference with Constitutionally Protected Property
Rights.

Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

Protection of Children

    We have analyzed this rule under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and does not create an
environmental risk to health or risk to safety that may
disproportionately affect children.

Indian Tribal Governments

    This rule does not have Tribal implications under Executive Order
13175, Consultation and Coordination with Indian Tribal Governments,
because it does not have a substantial direct effect on one or more
Indian Tribes, on the relationship between the Federal Government and
Indian Tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian Tribes.

Energy Effects

    We have analyzed this rule under Executive Order 13211, Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use. We have determined that it is not a ``significant
energy action'' under that order because it is not a ``significant
regulatory action'' under Executive Order 12866 and is not likely to
have a significant adverse effect on the supply, distribution, or use
of energy. The Administrator of the Office of Information and
Regulatory Affairs has not designated it as a significant energy
action. Therefore, it does not require a Statement of Energy Effects
under Executive Order 13211.

Technical Standards

    The National Technology Transfer and Advancement Act (NTTAA) (15
U.S.C. 272 note) directs agencies to use voluntary consensus standards
in their regulatory activities unless the agency provides Congress,
through the Office of Management and Budget, with an explanation of why
using these standards would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., specifications of materials, performance, design, or
operation; test methods; sampling procedures; and related management
systems practices) that are developed or adopted by voluntary consensus
standards bodies.
    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded
this action is one of a category of actions which do not individually
or cumulatively have a significant effect on the human environment.
This rule is categorically excluded, under figure 2-1, paragraph
(34)(g), of the Instruction. This rule involves the establishment of a
safety zone.
    An environmental analysis checklist and a categorical exclusion
determination are available in the docket where indicated under
ADDRESSES.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

0
For the reasons discussed in the preamble, the Coast Guard amends 33
CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority: 33 U.S.C. 1226, 1231; 46 U.S.C. Chapter 701, 3306,
3703; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, 160.5; Pub.
L. 107-295, 116 Stat. 2064; Department of Homeland Security
Delegation No. 0170.1.

0
2. Add a new temporary Sec.  165.T11-283 to read as follows:

Sec.  165.T11-283  Safety Zone; Havasu Landing Annual Regatta; Colorado
River, Lake Havasu Landing, CA.

    (a) Location. The limits of the safety zone will be the navigable
waters of the San Diego Bay bounded by the following coordinates:
    From the California shoreline in position 34[deg]29.40' N
114[deg]24.12' W to the northern corner 900 yards east in position
34[deg]29.40' N 114[deg]23.39' W to the southern corner 1400 yards
south in position 34[deg]29.0' N 114[deg]23.39' W to the California
shoreline in position 34[deg]29.0' N 114[deg]24.12' W.
    (b) Enforcement Period. This section will be enforced from 8 a.m.
to 4 p.m. on January 16, 2010 and January 17, 2010. If the event
concludes prior to the scheduled termination time, the Captain of the
Port will cease enforcement of this safety zone and will announce that
fact via Broadcast Notice to Mariners.
    (c) Definitions. The following definition applies to this section:
designated representative, means any commissioned, warrant, and petty
officers of the Coast Guard on board Coast Guard, Coast Guard
Auxiliary, and local, State, and Federal law enforcement vessels who
have been authorized to act on the behalf of the Captain of the Port.
    (d) Regulations. (1) Entry into, transit through or anchoring
within this safety zone is prohibited unless authorized by the Captain
of the Port of San Diego or his designated representative.
    (2) Mariners requesting permission to transit through the safety
zone may request authorization to do so from the Patrol Commander
(PATCOM). The PATCOM may be contacted on VHF-FM Channel 16.
    (3) All persons and vessels shall comply with the instructions of
the Coast Guard Captain of the Port or the designated representative.
    (4) Upon being hailed by U.S. Coast Guard patrol personnel by
siren, radio, flashing light, or other means, the operator of a vessel
shall proceed as directed.
    (5) The Coast Guard may be assisted by other Federal, State, or
local agencies.

    Dated: January 6, 2010.
T.H. Farris,
Captain, U.S. Coast Guard, Captain of the Port San Diego.
[FR Doc. 2010-763 Filed 1-13-10; 11:15 am]
BILLING CODE 9110-04-P


[Federal Register Volume 79, Number 100 (Friday, May 23, 2014)]
[Notices]
[Pages 29780-29781]
[FR Doc No: 2014-11924]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0610]

Increasing the Quality and Efficiency of Clinical Trials

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of grant funds for the support of the efforts of the
Center for Drug Evaluation and Research/Office of Medical Policy to
increase the quality and efficiency of clinical trials. The Food and
Drug Administration (FDA), Center for Drug Evaluation and Research
(CDER), Office of Medical Policy is announcing its intent to accept and
consider a single-source application for the award of a grant to the
Duke University's Duke Translational Medicine Institute (DTMI).

DATES: The application due date is June 30, 2014, by 11:59 p.m. Eastern
Time. The expiration date is July 1, 2014.

ADDRESSES: Submit electronic applications to: http://www.grants.gov.
For more information, see section III of the SUPPLEMENTARY INFORMATION
section of this notice.

FOR FURTHER INFORMATION CONTACT: Mark Lauda, Office of Medical Policy,
Center for Drug Evaluation and Research, Food and Drug Administration,
10990 New Hampshire Ave., Bldg. 51, Rm. 2212, Silver Spring, MD 20993,
301-796-0381, email<EMAIL_ADDRESS>or Lisa Ko, Office of
Acquisition & Grants Services, Food and Drug Administration, 5630
Fishers Lane, Rockville, MD,<PHONE_NUMBER>, email<EMAIL_ADDRESS>    For more information on this funding opportunity announcement (FOA)
and to obtain detailed requirements, please refer to the full FOA
located at http://www.grants.gov. Search by Funding Opportunity Number:
RFA-FD-14-017.

SUPPLEMENTARY INFORMATION:

I. Funding Opportunity Description

RFA-FD-14-017
93.103

A. Background

    It has long been recognized that the clinical trial enterprise will
need to evolve in order to meet the demand to provide data to support
evidence-based decisionmaking. A memorandum of understanding (MOU)
between FDA and Duke University published in the Federal Register on
November 23, 2007, served as the basis for the establishment of the
Clinical Trials Transformation Initiative (CTTI). CTTI is a public-
private partnership whose mission is to identify and promote practices
that will increase the quality and efficiency of clinical trials. This
award will be made to DTMI within Duke University to identify and
implement projects and disseminate resulting findings that will
increase the quality and efficiency of clinical trials, CTTI's mission.
    CTTI membership is broad and includes stakeholders from government,
industry, patient advocacy and consumer groups, professional societies,
clinical research organizations, and academia. CTTI helps to effect
change through the conduct of projects that identify existing
inefficiencies, elucidate superior practices, and/or provide innovative
approaches to evidence generation and medical product development. CTTI
conducts projects that are either: (1) Proposed by its member
organizations, including FDA, developed during review by its Steering
Committee, and endorsed by its Executive Committee or (2) responsive to
urgent needs of FDA.
    The opportunity for meaningful interaction with a broad set of
stakeholders committed to improving the clinical trial enterprise and
also the ability to rapidly gather data to address emerging issues
offer significant value to the clinical trial enterprise. Since its
inception, CTTI has undertaken many projects that have direct relevance
to FDA's mission, including investigational new drug (IND) safety
reporting, clinical trial monitoring, use of central investigational
review boards, and antibacterial drug development.

B. Research Objectives

    The goals of this program are to develop and maintain an
administrative and scientific infrastructure to support the creation
and execution of a series of projects under the auspices of CTTI that
will increase the quality and efficiency of clinical trials. The
following are examples of activities that could be supported by this
grant:
     Maintaining an adequate administrative and scientific
infrastructure to implement all related projects under this
collaborative effort.
     Identifying and/or hiring a sufficient number of qualified
personnel to conduct activities, including project management, such as
review of project milestones for degree of completion, preparation/
reporting of project findings, periodic and final reports, and for
subsequent distribution in the public domain.
     Developing plans for the conduct of identified projects.
     Identifying, securing, and/or building, and effectively
leveraging other resources for the conduct of identified projects.
     Upon completion of a given project, generating project
results and recommendations and proposing related studies/projects, if
needed, to build on the findings of the project and continuing to
leverage established resources and personnel.

C. Eligibility Information

    The following organization is eligible to apply: DTMI located
within Duke University.

II. Award Information/Funds Available

A. Award Amount

    This is a multiyear grant. FDA/CDER intends to fund up to
$7,500,000 in total costs (direct and indirect) in Fiscal Year 2014.
Awards are contingent upon the availability of funds.
    Subject to the availability of Federal funds and successful
performance of the FOA's stated goals and objectives, four additional
years of support may be

available. Funding beyond the first year will be noncompetitive and
will depend on: (1) Satisfactory performance during the preceding year
and (2) the availability of Federal fiscal year funds.
    Application budgets need to reflect the actual needs of the
proposed project and should not exceed the following in total costs
(direct and indirect):

Year 01: $7,500,000
Year 02: $7,500,000
Year 03: $7,500,000
Year 04: $7,500,000
Year 05: $7,500,000

B. Length of Support

    The scope of the proposed project should determine the project
period. The maximum project period is 5 years.

III. Electronic Application, Registration, and Submission

    Only electronic applications will be accepted. To submit an
electronic application in response to this FOA, applicants should first
review the full announcement located at http://www.grants.gov. Search
by Funding Opportunity Number: RFA-FD-14-017. (FDA has verified the Web
site addresses throughout this document, but FDA is not responsible for
any subsequent changes to the Web sites after this document publishes
in the Federal Register.) For all electronically submitted
applications, the following steps are required.

 Step 1: Obtain a Dun and Bradstreet (DUNS) Number
 Step 2: Register With System for Award Management (SAM)
 Step 3: Obtain Username & Password
 Step 4: Authorized Organization Representative (AOR)
Authorization
 Step 5: Track AOR Status
 Step 6: Register With Electronic Research Administration
(eRA) Commons

    Steps 1 through 5, in detail, can be found at http://www07.grants.gov/applicants/organization_registration.jsp. Step 6, in
detail, can be found at https://commons.era.nih.gov/commons/registration/registrationInstructions.jsp. After you have followed
these steps, submit electronic applications to: http://www.grants.gov.

    Dated: May 15, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-11924 Filed 5-22-14; 8:45 am]
BILLING CODE 4160-01-P