[Federal Register Volume 85, Number 78 (Wednesday, April 22, 2020)]
[Proposed Rules]
[Pages 22381-22384]
[FR Doc No: 2020-08240]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R03-OAR-2018-0042; FRL-10007-90-Region 3]

Air Plan Disapproval; Maryland; Interstate Transport Requirements
for the 2010 1-Hour Sulfur Dioxide National Ambient Air Quality
Standard

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
disapprove part of a Maryland state implementation plan (SIP)
submission as inadequate to meet certain Clean Air Act (CAA) interstate
transport requirements for the 2010 primary sulfur dioxide National
Ambient Air Quality Standard (SO2 NAAQS). Specifically, EPA
proposes to find that the Maryland SIP submission does not contain
adequate provisions prohibiting emissions from Maryland sources which
will contribute significantly to nonattainment or interfere with
maintenance of the 2010 SO2 NAAQS in any other state.

DATES: Written comments must be received on or before May 22, 2020.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R03-
OAR-2018-0042 at https://www.regulations.gov, or via email to
<EMAIL_ADDRESS>For comments submitted at Regulations.gov,
follow the online instructions for submitting comments. Once submitted,
comments cannot be edited or removed from Regulations.gov. For either
manner of submission, EPA may publish any comment received to its
public docket. Do not submit electronically any information you
consider to be confidential business information (CBI) or other
information whose disclosure is restricted by statute. Multimedia
submissions (audio, video, etc.) must be accompanied by a written
comment. The written comment is considered the official comment and
should include discussion of all points you wish to make. EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e., on the web, cloud, or other file sharing
system). For additional submission methods, please contact the person
identified in the FOR FURTHER INFORMATION CONTACT section. For the full
EPA public comment policy, information about CBI or multimedia
submissions, and general guidance on making effective comments, please
visit https://www.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Megan Goold, Planning & Implementation
Branch (3AD30), Air & Radiation Division, U.S. Environmental Protection
Agency, Region III, 1650 Arch Street, Philadelphia, Pennsylvania 19103.
The telephone number is<PHONE_NUMBER>. Ms. Goold can also be reached
via electronic mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    On June 22, 2010 (75 FR 35520), EPA promulgated a revised primary
NAAQS for SO2 at a level of 75 parts per billion (ppb),
based on a 3-year average of the annual 99th percentile of 1-hour daily
maximum concentrations. Pursuant to section 110(a)(1), states must
submit ``within 3 years (or such shorter period as the Administrator
may prescribe) after the promulgation of a national primary ambient air
quality standard (or any revision thereof),'' a plan that provides for
the ``implementation, maintenance, and enforcement'' of such NAAQS.
This SIP submission is generally referred to as an ``infrastructure
SIP.'' The statute directly imposes on states the duty to make these
SIP submissions, and the requirement to make the submissions is not
conditioned upon EPA's taking any action other than promulgating a new
or revised NAAQS. Section 110(a)(2) includes a list of specific
elements that ``[e]ach such plan'' submission must address to meet the
infrastructure requirements. Among the section 110(a)(2) requirements
are the requirements under section 110(a)(2)(D)(i)(I) for states to
include adequate provisions in their SIPs that prohibit emissions
within the state which will contribute significantly to nonattainment
in, or interfere with maintenance by, any other state with respect to a
NAAQS. This infrastructure element related to interstate transport of
SO2 is the subject of this proposed rulemaking action.

II. Relevant Factors To Evaluate 2010 SO2 Interstate
Transport SIPs

    Although SO2 is emitted from a similar universe of point
and nonpoint sources, interstate transport of SO2 is unlike
the transport of fine particulate matter (PM2.5) or ozone,
in that SO2 is not a regional pollutant and does not
commonly contribute to widespread nonattainment over a large (and often
multi-state) area. The transport of SO2 is more analogous to
the transport of lead (Pb) because its physical properties result in
localized pollutant impacts very near the emissions source. However,
ambient concentrations of SO2 do not decrease as quickly
with distance from the source as Pb because of the physical properties
and typical release heights of SO2. Emissions of
SO2 travel farther and have wider ranging impacts than
emissions of Pb but do not travel far enough to be treated in a manner
similar to ozone or PM2.5. The approaches that the EPA has
adopted for ozone or PM2.5 transport are too regionally
focused and the approach for Pb transport is too tightly circumscribed
to the source to serve as a model for SO2 transport.
SO2 transport is therefore a unique case and requires a
different approach.
    In this proposed rulemaking, as in prior SO2 transport
analyses, EPA focuses on a 50 kilometer-wide zone around large
stationary sources of SO2 because the physical properties of
SO2 result in relatively localized pollutant impacts near an
emissions source that diminish with distance. Given the physical
properties of SO2, EPA selected the ``urban scale''--a
spatial scale with dimensions from 4 to 50 kilometers (km) from point
sources--given the usefulness of that range in assessing trends in both
area-wide air quality and the effectiveness of large-scale pollution
control strategies at such point sources.\1\ As such, EPA utilized an
assessment up to 50 km from point sources in order to assess trends in
area-wide air quality that might impact downwind states.
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    \1\ For the definition of spatial scales for SO2, see
40 CFR part 58, appendix D, section 4.4 (``Sulfur Dioxide
(SO2) Design Criteria''). For further discussion on how
EPA is applying these definitions with respect to interstate
transport of SO2, see EPA's proposal on Connecticut's
SO2 transport SIP. 82 FR 21351, 21352, 21354 (May 8,
2017).
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III. Summary of State SIP Revision

    On August 17, 2016, Maryland, through the Maryland Department of
the Environment (MDE), submitted a SIP revision, consistent with EPA
guidance, to satisfy most of the infrastructure requirements of CAA
section 110(a)(2) for the 2010 SO2 NAAQS.\2\
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    \2\ Consistent with ``Guidance on Infrastructure SIP Elements
under Clean Air Act Sections 110(a)(1) and 110(a)(2),'' Memorandum
from Stephen D. Page, September 13, 2013. The Maryland SIP
submission addressed all of the infrastructure requirements of
section 110(a)(2) except for requirements concerning nonattainment
new source review permit programs under 110(a)(2)(C) and the
nonattainment planning requirements under part D, title I of the CAA
found at 110(a)(2)(I). These elements are not subject to the same
three-year deadline for adoption as the other 110(a)(2)
requirements.
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    On May 8, 2019 (84 FR 20070), EPA proposed approval of Maryland's
infrastructure SIP submittal for the 2010

1-hour SO2 NAAQS for all of the submitted applicable
elements of section 110(a)(2) with the exception of 110(a)(2)(D)(i)(I),
which are the interstate transport elements. In that action, EPA stated
that it would act on the interstate transport elements in a future
action. This proposed rulemaking action addresses those interstate
transport elements.
    In Maryland's August 17, 2016 SIP submittal, MDE discusses various
State and Federal measures which it asserts prohibit Maryland sources
from emitting SO2 at levels which would contribute
significantly to nonattainment or interfere with maintenance of the
SO2 NAAQS in another state, including: (1) The Healthy Air
Act (HAA), which was enacted in 2006, as well as its implementing
regulations at Code of Maryland Regulations (COMAR) 26.11.27 (adopted
into the SIP in 2017 (73 FR 51599)), which require reductions in total
emissions of SO2 from electric generating units (EGUs); (2)
a July 11, 2013 consent decree between Holcim, Incorporated and the
U.S. government which requires Holcim to replace units at its
Hagerstown, Maryland facility and install controls with significant
SO2 reductions; and (3) the State's Regional Haze SIP,
approved by EPA on July 6, 2012 (77 FR 39938), which reduces
SO2 from Maryland sources subject to Best Available Retrofit
Technology (BART) requirements.
    Maryland also considered four existing SO2 nonattainment
areas in Pennsylvania, West Virginia, and Ohio, as well as one area in
Ohio that was not yet characterized at the time of Maryland's August
17, 2016 submittal but that Maryland considered a potential
nonattainment area. Maryland determined that the distance from Maryland
state borders to the existing nonattainment areas or to the potential
nonattainment area was beyond the range of concern for transported
SO2 emissions.\3\ Likewise, Maryland considered a potential
nonattainment area in the State that had not yet been characterized and
determined that the distance (39 miles or approximately 63 km) from the
large SO2 sources in that uncharacterized area to a
neighboring state was also beyond the range of concern for
SO2 transport.
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    \3\ The distance from Maryland's nearest border to the Allegheny
County, Pennsylvania SO2 nonattainment area is 49 miles
(approximately 79 km), to the Indiana, Pennsylvania SO2
nonattainment area is 59 miles (approximately 95 km), to the
Marshall, West Virginia SO2 nonattainment area is 69
miles (approximately 111 km) and to the Weirton-Steubenville, Ohio-
West Virginia SO2 nonattainment area is 78 miles
(approximately 126 km). The distance from Maryland's state border to
Ohio's potential nonattainment area is 142 miles (approximately 229
km).
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IV. EPA's Analysis of Maryland's Submittal

    The EPA generally agrees that the Federally enforceable measures
described in Maryland's August 17, 2016 SIP submittal have contributed
to reductions of SO2 emissions at specific sources
throughout the State. However, the submittal does not address
SO2 emissions from the Luke Paper Mill (Luke) that current
ambient monitoring data demonstrate as contributing significantly to
nonattainment of the 2010 SO2 NAAQS in West Virginia.
    On August 21, 2015 (80 FR 51052), EPA promulgated air quality
characterization requirements for the 2010 1-hour SO2 NAAQS
in the Data Requirements Rule (DRR). The DRR requires state and local
air agencies to characterize air quality, through air dispersion
modeling or monitoring, in areas associated with sources that emitted
2,000 tons per year (tpy) or more of SO2, or that have
otherwise been listed under the DRR by EPA or state air agencies. EPA
expected that the information generated by implementation of the DRR
would help inform designations for the 2010 1-hour SO2
NAAQS, including designations of the remaining undesignated areas that
must be completed by December 31, 2020 (``round 4''), as well as for
other CAA programs. New source-oriented monitors were required to be
operational by January 1, 2017.
    Luke, in Allegany County, Maryland, is a source of SO2
emissions located on the West Virginia state border. Luke emitted
greater than 2,000 tons of SO2 in 2014 and was therefore
required to be characterized pursuant to the DRR. Maryland elected to
install new source-oriented monitors to capture the maximum impacts
from Luke.\4\ Two monitors were installed in Allegany County, Maryland,
and one monitor was installed in Mineral County, West Virginia. These
three monitors were installed in accordance with EPA's Source-Oriented
Monitoring Technical Assistance Document \5\ as described in Maryland's
Annual Monitoring Network Plan (AMNP) for Calendar Year 2017 and the
accompanying Addendum, which were both approved by EPA on November 10,
2016.\6\
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    \4\ Maryland's 2016 Annual Monitoring Network Plan details the
modeling used to site the three new monitors around the Luke Paper
facility. Through that plan, EPA approved the new monitor locations.
    \5\ See EPA's SO2 NAAQS Designations Source-Oriented
Monitoring Technical Assistance Document (TAD), February 2016, at
https://www3.epa.gov/airquality/so2implementation/SO2MonitoringTAD.pdf.
    \6\ As required by 40 CFR 58.10, Maryland submits an AMNP
annually to EPA that details any modifications to the monitoring
network. The AMNPs for calendar years 2017-2019 are provided in the
docket for this rulemaking. EPA's approval of each AMNP is included
in the subsequent year's AMNP in the docket.
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    The three source-oriented monitors around the Luke facility began
operating after this SIP was submitted in 2016. The two Maryland
monitors began operating on January 11, 2017 and the West Virginia
monitor began operating on February 24, 2017.
    Table 1 shows the certified 99th percentile of daily maximum 1-hour
concentrations at the three new monitors for 2017 and 2018, as well as
the preliminary 99th percentile concentration for 2019.\7\ The 2019
data is preliminary because it has not yet been quality assured and
certified. Maryland is required to certify the 2019 data for all three
monitors by May 1, 2020.
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    \7\ To certify monitoring data, state or local air agencies
upload their data to the EPA Air Quality System (AQS) for the year,
review their data, correct it as needed, and ``certify'' their data
in the system.
    \8\ Data source: EPA AQS, https://www.epa.gov/aqs.

                         Table 1--Monitored SO2 Concentrations, in ppb, Around Luke \8\
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                                                                                Preliminary
                                                     2017 99th       2018 99th      Preliminary       2017-19
          County, state             Monitor ID      percentile      percentile       2019 99th        average
                                                                                percentile    (design value)
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Mineral, WV.....................     54-057-8883           186.8           203.3           134.9             175
Allegany, MD....................     24-001-8881            88.8           105.7            71.7              89
Allegany, MD....................     24-001-8882           152.3           172.5             144             156
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    A monitoring site in an area is determined to be meeting the 2010
primary 1-hour SO2 NAAQS when the 99th percentile of the
daily maximum 1-hour average concentrations, averaged over three years,
does not exceed 75 ppb (40 CFR 50.17(b)). Two years of certified data
shows the 2017 and 2018 99th percentile concentrations at the Mineral
County, West Virginia monitor as 186.8 ppb and 203.3 ppb, respectively.
The preliminary 2019 99th percentile 1-hour maximum concentration and
the projected design value using the preliminary 2019 99th percentile
1-hour maximum concentration are also shown in the table. The
preliminary 2017-2019 design value at the Mineral County, West Virginia
monitor is 175 ppb, using certified 2017-2018 data and preliminary 2019
data. This monitor would not show levels meeting the standard
regardless of the certified 99th percentile value for 2019 because even
if the 99th percentile value for 2019 was zero, the 3-year design value
would still violate the NAAQS ((186.8 ppb + 203.3 ppb + 0 ppb)/3 =
130.03 ppb). This means it is mathematically impossible for this
monitor to show attainment with the 2010 SO2 NAAQS.
    Luke is the only source \9\ that emits greater than 100 tpy of
SO2 in the area near the Mineral County, West Virginia
monitor.\10\ Based on the information contained in this notice, EPA
proposes to conclude that Luke is impacting a violation of the NAAQS in
the neighboring state of West Virginia. Therefore, EPA proposes that
Luke significantly contributes to projected nonattainment in West
Virginia. EPA is aware that Luke has ceased operations as of June 2019,
however, as of the date of this action, Luke has not surrendered its
permit(s) and there are no Federally enforceable measures in Maryland's
SIP to prevent Luke from restarting operations and emitting
SO2 at levels that contribute significantly to nonattainment
or interfere with the maintenance of the 2010 SO2 NAAQS in
West Virginia.
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    \9\ While there are other SO2 emissions sources near
the primary Luke facility and its associated source-oriented
monitors, these smaller sources are either also owned by Luke, have
low SO2 emissions compared to the primary Luke facility,
or are located a far enough distance away that they are likely not
significant contributors to the violating monitors given the nature
of SO2 dispersion described in section II.
    \10\ There is a SO2 source about 35 km away in
neighboring Grant County, West Virginia, that was required to be
characterized pursuant the DRR. In Round 3 of SO2
designations, EPA designated the area around Dominion Resources, Mt.
Storm Power Station as Attainment/Unclassifiable based on modeling
performed by the State of West Virginia. This modeling projected the
peak impacts from the Mt. Storm plant to be south of the facility,
away from the area around the Luke facility. See ``Technical Support
Document: Chapter 43 Intended Round 3 Area Designations for the 2010
1-Hour SO2 Primary National Ambient Air Quality Standard
for West Virginia'' at https://www.epa.gov/sites/production/files/2017-08/documents/43_wv_so2_rd3-final.pdf. See also ``Technical
Support Document: Chapter 43 Final Round 3 Area Designations for the
2010 1-Hour SO2 Primary National Ambient Air Quality
Standard for West Virginia'' at https://www.epa.gov/sites/production/files/2017-12/documents/43-wv-so2-rd3-final.pdf.
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V. Proposed Action

    EPA is proposing to determine that the portion of the August 17,
2016 Maryland SO2 infrastructure SIP submittal addressing
CAA section 110(a)(2)(D)(i)(I) (the interstate transport of pollution)
is not approvable because it does not include measures addressing the
SO2 emissions from the Luke Paper Mill in Maryland that,
based on the available information described herein, EPA believes will
contribute significantly to the projected nonattainment in West
Virginia or will interfere with maintenance of the 2010 SO2
NAAQS.

VI. Statutory and Executive Order Reviews

Executive Orders 12866 and 13563: Regulatory Planning and Review

    Under Executive Orders 12866 (58 FR 51735, October 4, 1993) and
13563 (76 FR 3821, January 21, 2011), this action is not a
``significant regulatory action'' and, therefore, is not subject to
review by the Office of Management and Budget.

Executive Order 13771: Reducing Regulations and Controlling Regulatory
Costs

    This action is not an Executive Order 13771 regulatory action
because this action is not significant under Executive Order 12866.

Paperwork Reduction Act

    This rule does not impose an information collection burden under
the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
et seq.).

Regulatory Flexibility Act

    This action merely proposes to disapprove state requirements as not
meeting Federal requirements and imposes no additional requirements
beyond those imposed by state law. Accordingly, the Administrator
certifies that this rule will not have a significant economic impact on
a substantial number of small entities under the Regulatory Flexibility
Act (5 U.S.C. 601 et seq.).

Unfunded Mandates Reform Act

    Because this rule proposes to disapprove pre-existing requirements
under state law and does not impose any additional enforceable duty
beyond that required by state law, it does not contain any unfunded
mandate or significantly or uniquely affect small governments, as
described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4).

Executive Order 13132: Federalism

    This action also does not have Federalism implications because it
does not have substantial direct effects on the states, on the
relationship between the national government and the states, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132 (64 FR 43255, August
10, 1999). This action merely proposes to disapprove a state
requirement and does not alter the relationship or the distribution of
power and responsibilities established in the CAA.

Executive Order 13175: Consultation and Coordination With Indian Tribal
Governments

    In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where EPA or an Indian tribe has
demonstrated that a tribe has jurisdiction. In those areas of Indian
country, the rule does not have tribal implications and will not impose
substantial direct costs on tribal governments or preempt tribal law as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

Executive Order 13045: Protection of Children From Environmental Health
and Safety Risks

    This rule also is not subject to Executive Order 13045 ``Protection
of Children from Environmental Health Risks and Safety Risks'' (62 FR
19885, April 23, 1997), because it proposes to disapprove a state rule.

Executive Order 13211: Actions That Significantly Affect Energy Supply,
Distribution, or Use

    Because it is not a ``significant regulatory action'' under
Executive Order 12866 or a ``significant energy action,'' this action
is also not subject to Executive Order 13211. (66 FR 28355, May 22,
2001).

National Technology Transfer Advancement Act

    In reviewing state submissions, EPA's role is to approve state
choices, provided that they meet the criteria of

the CAA. In this context, in the absence of a prior existing
requirement for the state to use voluntary consensus standards (VCS),
EPA has no authority to disapprove a state submission for failure to
use VCS. It would thus be inconsistent with applicable law for EPA,
when it reviews a state submission, to use VCS in place of a state
submission that otherwise satisfies the provisions of the CAA. Thus,
the requirements of section 12(d) of the National Technology Transfer
and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply.

Executive Order 12898: Federal Actions To Address Environmental Justice
in Minority Populations and Low-Income Populations

    Executive Order 12898 (59 FR 7629 (February 16, 1994)) establishes
Federal executive policy on environmental justice. Its main provision
directs Federal agencies, to the greatest extent practicable and
permitted by law, to make environmental justice part of their mission
by identifying and addressing, as appropriate, disproportionately high
and adverse human health or environmental effects of their programs,
policies, and activities on minority populations and low-income
populations in the United States.
    EPA lacks the discretionary authority to address environmental
justice in this action. In reviewing SIP submissions, EPA's role is to
approve or disapprove state choices, based on the criteria of the CAA.
Accordingly, this action merely disapproves certain state requirements
for inclusion into the SIP under section 110 of the CAA and will not
in-and-of itself create any new requirements. Accordingly, it 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.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Sulfur oxides.

    Dated: April 13, 2020.
Cosmo Servidio,
Regional Administrator, Region III.
[FR Doc. 2020-08240 Filed 4-21-20; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register: April 18, 2008 (Volume 73, Number 76)]
[Proposed Rules]
[Page 21074-21076]
[DOCID:fr18ap08-14]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2008-0444; Directorate Identifier 2008-CE-024-AD]
RIN 2120-AA64

Airworthiness Directives; Viking Air Limited Models DHC-2 Mk. I,
DHC-2 Mk. II, and DHC-3 Airplanes

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

ACTION: Notice of proposed rulemaking (NPRM).

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

    A complete loss of both ignition systems occurred on a DHC-3
Otter when the lock wire hole in the ignition connector plug on the
firewall broke out, allowing the plug to vibrate loose. A
maintenance safety feature grounds out both magneto systems through
a spring-loaded safety pin incorporated into the Cannon plug. The
DHC-2 system is similar in design.
    Subsequent to the issuance of AD CF-2001-36 a complete loss of
both ignition systems occurred on a DHC-2 Beaver resulting in engine
failure and subsequent forced approach and landing. Investigation by
the Transportation Safety Board determined the internal failure of
the magneto firewall connector resulted in both magneto ``P'' leads
shorting to ground. A maintenance ``safety'' feature through a
spring-loaded safety pin incorporated in the firewall connector on
many DHC-2 aircraft grounds out both magneto systems when the
connector is disconnected. This connector type is readily identified
when disconnected by the existence of three internal pins on the
firewall and magneto harness side, one of which is shorted directly
to ground.

The proposed AD would require actions that are intended to address the
unsafe condition described in the MCAI.

DATES: We must receive comments on this proposed AD by May 19, 2008.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://
www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.

Examining the AD Docket

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

FOR FURTHER INFORMATION CONTACT: Fabio Buttitta, Aerospace Engineer,
FAA, New York Aircraft Certification Office, 1600 Stewart Avenue, Suite
410, Westbury, New York 11590; telephone:<PHONE_NUMBER>; fax: (516)
794-5531.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2008-0444;
Directorate Identifier 2008-CE-024-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD because of those comments.
    We will post all comments we receive, without change, to http://
regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    On October 12, 2004, we issued AD 2004-21-06, Amendment 39-13827
(69 FR 61758, October 21, 2004). That AD required actions intended to
address an unsafe condition on the products listed above.
    Since we issued AD 2004-21-06, the manufacturer has developed a
modification kit to replace the magneto firewall connector with parts
of improved design.
    Transport Canada, which is the aviation authority for Canada, has
issued AD No. CF-2001-36R1, dated January 21, 2008, and AD No. CF-2001-
37R, dated January 21, 2008 (referred to after this as ``the MCAI''),
to correct an unsafe condition for the specified products. The MCAI
states:

    A complete loss of both ignition systems occurred on a DHC-3
Otter when the lock wire hole in the ignition connector plug on the
firewall broke out, allowing the plug to vibrate loose. A
maintenance safety feature grounds out both magneto systems through
a spring-loaded safety pin incorporated into the Cannon plug. The
DHC-2 system is similar in design.
    Subsequent to the issuance of AD CF-2001-36 a complete loss of
both ignition systems occurred on a DHC-2 Beaver resulting in engine
failure and subsequent forced approach and landing. Investigation by
the Transportation Safety Board determined the internal failure of
the magneto firewall connector resulted in both magneto ``P'' leads
shorting to ground. A maintenance ``safety'' feature through a
spring-loaded safety pin incorporated in the firewall connector on
many DHC-2 aircraft ground out both magneto systems when the

connector is disconnected. This connector type is readily identified
when disconnected by the existence of three internal pins on the
firewall and magneto harness side, one of which is shorted directly
to ground.
    These connectors are no longer in production.
    Since no effective Instructions for Continued Airworthiness
exist to ensure the safety feature of these connectors will operate
correctly when disconnected, or will ensure the internal integrity
of the connector while in service, this directive is revised to
mandate replacement of connectors with a different design.
    Viking Air Limited has developed SB V2/0001 to provide for the
installation of a replacement connector, similar in design to
magneto systems in service today. This modification incorporates a
``straight through'' type connector, ensuring magneto circuit
integrity should the connection open.

You may obtain further information by examining the MCAI in the AD
docket.

Relevant Service Information

    Viking Air Limited has issued the following service bulletins:
     Viking DHC-2 Beaver Service Bulletin Number V2/0001, dated
June 27, 2007; and
     Viking DHC-3 Otter Service Bulletin Number V3/0001, dated
June 27, 2007.
    The actions described in this service information are intended to
correct the unsafe condition identified in the MCAI.

FAA's Determination and Requirements of the Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with this State of Design Authority, they
have notified us of the unsafe condition described in the MCAI and
service information referenced above. We are proposing this AD because
we evaluated all information and determined the unsafe condition exists
and is likely to exist or develop on other products of the same type
design.

Differences Between This Proposed AD and the MCAI or Service
Information

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

Costs of Compliance

    We estimated that this proposed AD will affect 159 products of U.S.
registry. We also estimate that it would take about 10 work-hours per
product to comply with the basic requirements of this proposed AD. The
average labor rate is $80 per work-hour. Required parts would cost
about $881 per product.
    Based on these figures, we estimate the cost of the proposed AD on
U.S. operators to be $267,279, or $1,681 per product.

Authority for This Rulemaking

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

Regulatory Findings

    We determined that this 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. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979); and
    3. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a regulatory evaluation of the estimated costs to
comply with this proposed AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, 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

    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]

    2. The FAA amends Sec.  39.13 by removing Amendment 39-13827 (69 FR
61758; October 21, 2004), and adding the following new AD:

Viking Air Limited: Docket No. FAA-2008-0444; Directorate Identifier
2008-CE-024-AD.

Comments Due Date

    (a) We must receive comments by May 19, 2008.

Affected ADs

    (b) This AD supersedes AD 2004-21-06, Amendment 39-13827.

Applicability

    (c) This AD applies to the following model and serial number
airplanes certificated in any category:

------------------------------------------------------------------------
                 Model                             Serial No.
------------------------------------------------------------------------
DHC-2 Mk. I...........................  All.
DHC-2 Mk. II..........................  All.
DHC-3.................................  All serial numbers with piston
                                         engines.
------------------------------------------------------------------------

Subject

    (d) Air Transport Association of America (ATA) Code 26: Fire
Protection.

Reason

    (e) The mandatory continuing airworthiness information (MCAI)
states:
    A complete loss of both ignition systems occurred on a DHC-3
Otter when the lock wire hole in the ignition connector plug on the
firewall broke out, allowing the plug to vibrate loose. A
maintenance safety feature grounds out both magneto systems through
a spring-loaded safety pin incorporated into the Cannon plug. The
DHC-2 system is similar in design.
    Subsequent to the issuance of AD CF-2001-36 a complete loss of
both ignition systems occurred on a DHC-2 Beaver resulting in engine
failure and subsequent forced approach and landing. Investigation by
the Transportation Safety Board

determined the internal failure of the magneto firewall connector
resulted in both magneto ``P'' leads shorting to ground. A
maintenance ``safety'' feature through a spring-loaded safety pin
incorporated in the firewall connector on many DHC-2 aircraft ground
out both magneto systems when the connector is disconnected. This
connector type is readily identified when disconnected by the
existence of three internal pins on the firewall and magneto harness
side, one of which is shorted directly to ground.
    These connectors are no longer in production.
    Since no effective Instructions for Continued Airworthiness
exist to ensure the safety feature of these connectors will operate
correctly when disconnected, or will ensure the internal integrity
of the connector while in service, this directive is revised to
mandate replacement of connectors with a different design.
    Viking Air Limited has developed SB V2/0001 to provide for the
installation of a replacement connector, similar in design to
magneto systems in service today. This modification incorporates a
``straight through'' type connector, ensuring magneto circuit
integrity should the connection open.

Actions and Compliance

    (f) Inspect the connector plugs on the fore side of the firewall
for security and the connector plug lockwire to ensure it is intact
and the holes in the plugs are not broken out or cracked. Initially
inspect within the next 100 hours time-in-service (TIS) after
December 6, 2004 (the compliance date retained from AD 2004-21-06).
Repetitively inspect thereafter at intervals not to exceed 100 hours
TIS until the modification required in paragraph (h) of this AD is
done. Do the inspections following deHavilland Beaver Alert Service
Bulletin Number A2/53, Revision B, dated May 28, 2004; and
deHavilland Otter Alert Service Bulletin Number A3/53, Revision B,
dated May 28, 2004, as applicable.
    (g) During any inspection required in paragraph (f) of this AD,
if the lockwire holes or the lockwire is found damaged, install
Modification Kit Number C2VMK0001-1 or Modification Kit Number
C3VMK0001-1, as applicable. Install the modification kit before
further flight following the Accomplishment Instructions in Viking
DHC-2 Beaver Service Bulletin Number V2/0001, dated June 27, 2007;
and Viking DHC-3 Otter Service Bulletin Number V3/0001, dated June
27, 2007, as applicable. Installing the modification kit terminates
the repetitive inspections required in paragraph (f) of this AD.
    (h) Unless already done, replace the magneto firewall connector
by installing Modification Kit Number C2VMK0001-1 or Modification
Kit Number C3VMK0001-1, as applicable. Install the modification kit
within the next 6 months after the effective date of this AD
following the Accomplishment Instructions in Viking DHC-2 Beaver
Service Bulletin Number V2/0001, dated June 27, 2007; and Viking
DHC-3 Otter Service Bulletin Number V3/0001, dated June 27, 2007, as
applicable. Installing the modification kit terminates the
repetitive inspections required in paragraph (f) of this AD.

FAA AD Differences

    Note: This AD differs from the MCAI and/or service information
as follows: AD 2004-21-06 required incorporating repetitive
inspections of the connector plugs and the connector plug lockwire
on the fore side of the firewall into the maintenance program while
the MCAI required incorporating Temporary Revision No. 14, dated
August 24, 2001, into the applicable maintenance manual in order to
incorporate the repetitive inspections into the maintenance program.

Other FAA AD Provisions

    (i) The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager, New
York Aircraft Certification Office (ACO), FAA, has the authority to
approve AMOCs for this AD, if requested using the procedures found
in 14 CFR 39.19. Send information to ATTN: Fabio Buttitta, Aerospace
Engineer, FAA, New York ACO, 1600 Stewart Avenue, Suite 410,
Westbury, New York 11590; telephone:<PHONE_NUMBER>; fax: (516) 794-
5531. Before using any approved AMOC on any airplane to which the
AMOC applies, notify your appropriate principal inspector (PI) in
the FAA Flight Standards District Office (FSDO), or lacking a PI,
your local FSDO.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.
    (3) Reporting Requirements: For any reporting requirement in
this AD, under the provisions of the Paperwork Reduction Act (44
U.S.C. 3501 et seq.), the Office of Management and Budget (OMB) has
approved the information collection requirements and has assigned
OMB Control Number 2120-0056.

Related Information

    (j) Refer to MCAI Transport Canada AD No. CF-2001-36R1, dated
January 21, 2008; and AD No. CF-2001-37R, dated January 21, 2008;
and Viking Air Limited DHC-2 Beaver Service Bulletin Number V2/0001,
dated June 27, 2007; and Viking Air Limited DHC-3 Otter Service
Bulletin Number V3/0001, dated June 27, 2007; for related
information.

    Issued in Kansas City, Missouri, on April 11, 2008.
James E. Jackson,
Acting Manager, Small Airplane Directorate, Aircraft Certification
Service.
 [FR Doc. E8-8365 Filed 4-17-08; 8:45 am]

BILLING CODE 4910-13-P


DuPont Chemical Solutions Enterprise

Chambers Works

Deepwater, NJ  08023

CERTIFIED MAIL – Return Receipt Requested

July 23, 2008

Document Control Office

US Environmental Protection Agency

Office of Pollution Prevention and Toxics

EPA East

Room 6428

1200 Pennsylvania Avenue, NW

Washington, DC 20460

Re: 	EPA – HQ – OPPT – 2003 - 0012

	DuPont Chambers Works NJPDES Permit No. NJ0005100

	PFOA Data Submittal – Outfall DSN662 Weekly Grab Samples

	May 2008 Sample Data

Dear Document Control Office:

As per Part IV, Section G.5.a of the NJPDES permit, we are submitting a summary of PFOA analytical results for the weekly grab samples taken at internal outfall DSN662A to NJDEP on a monthly basis. Per your request, we are sending you a paper and electronic copy of the report for samples taken during May 2008. We will continue to send you the reports each month.

If you have any questions, please do not hesitate to call me at (856) 540-3015.

Sincerely,

Karen L. Pinder

SET Environmental Coordinator

DuPont Chambers Works

Enclosures

Copies to:

Director, Chemical Control Division

US Environmental Protection Agency

Office of Pollution Prevention and Toxics

EPA East

Room 4146

1201 Constitution Avenue, NW

Washington, DC 20004

Ms. Susan Rosenwinkel (cover letter only)

Principal Environmental Engineer

NJDEP Division of Water Quality

Bureau of Point Source Permitting – Region 2

401 E. State Street

P.O. Box 029

Trenton, NJ 08625-0029


[Federal Register Volume 88, Number 38 (Monday, February 27, 2023)]
[Notices]
[Pages 12369-12374]
[FR Doc No: 2023-03946]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0028]

Timothy Baxter; Denial of Hearing; Final Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is denying a
request for a hearing submitted by Dr. Timothy Baxter (Dr. Baxter) and
is issuing an order under the Federal Food, Drug, and Cosmetic Act
(FD&C Act) debarring Dr. Baxter for 5 years from providing services in
any capacity to a person that has an approved or pending drug product
application. FDA bases this order on a finding that Dr. Baxter was
convicted of a misdemeanor under Federal law for conduct relating to
the regulation of a drug product under the FD&C Act and that the type
of conduct underlying the conviction undermines the process for the
regulation of drugs. In determining the appropriateness and period of
Dr. Baxter's debarment, FDA has considered the applicable factors
listed in the FD&C Act. Dr. Baxter has failed to file with the Agency
information and analyses sufficient to create a basis for a hearing
concerning this action.

DATES: The order is applicable February 27, 2023.

ADDRESSES: Any application for termination of debarment by Dr. Baxter
under section 306(d) of the FD&C Act (21 U.S.C. 335a(d)) (application)
may be submitted as follows:

Electronic Submissions

     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. An application
submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because
your application will be made public, you are solely responsible for
ensuring that your application does not include any confidential
information that you or a third party may not wish to be posted, such
as medical information, your or anyone else's Social Security number,
or confidential business information, such as a manufacturing process.
Please note that if you include your name, contact information, or
other information that identifies you in the body of your application,
that information will be posted on https://www.regulations.gov.
     If you want to submit an application with confidential
information that you do not wish to be made available to the public,
submit the application as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For a written/paper application submitted to the Dockets
Management Staff, FDA will post your application, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: Your application must include the Docket No. FDA-
2021-N-0028. An application will be placed in the docket and, unless
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit an application with
confidential information that you do not wish to be made publicly
available, submit your application only as a written/paper submission.
You should submit two copies total. One copy will include the
information you claim to be confidential with a heading or cover note
that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The
Agency will review this copy, including the claimed confidential
information, in its consideration of your application. The second copy,
which will have the claimed confidential information redacted/blacked
out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management
Staff. If you do not wish your name and contact information to be made
publicly available, you can provide this information on the cover sheet
and not in the body of your application and you must identify this
information as ``confidential.'' Any information marked as
``confidential'' will not be disclosed except in accordance with 21 CFR
10.20 and other applicable disclosure law. For more information about
FDA's posting of comments to public dockets, see 80 FR 56469, September
18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket, go to https://www.regulations.gov
and insert the docket number, found in brackets in the heading of this
document, into the ``Search'' box and follow the prompts and/or go to
the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852 between 9 a.m. and 4 p.m., Monday through Friday, 240-402-
7500. Publicly available submissions may be seen in the docket.

FOR FURTHER INFORMATION CONTACT: Rachael Vieder Linowes, Office of
Scientific Integrity, Food and Drug Administration,
[email protected],<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 306(b)(2)(B)(i)(I) of the FD&C Act permits FDA to debar an
individual if it finds that: (1) the individual has been convicted of a
misdemeanor under Federal law ``for conduct relating to the development
or approval, including the process for development or approval, of any
drug product or otherwise relating to the regulation of drug products''
under the FD&C Act and (2) the type of conduct that served as the basis
for the conviction undermines the process for the regulation of drugs.
    On August 31, 2020, in the U.S. District Court for the Western
District of Virginia, Dr. Baxter pled guilty to a misdemeanor violation
of the FD&C Act. Specifically, he pled guilty to causing the
introduction or delivery for introduction of a misbranded drug into
interstate commerce in violation of sections 301(a), 303(a)(1), and
502(a) of the FD&C Act (21 U.S.C. 331(a), 333(a)(1), and 352(a)). In
the plea agreement pursuant to which Dr. Baxter pled guilty, he agreed
that ``all the facts set forth in the Information [filed by the Federal
government on the same day] are true and correct and provide the Court
with a sufficient factual basis to support [his] plea.'' The
Information provided that, at the time of the conduct underlying his
conviction, Dr. Baxter was the Global Medical Director of Reckitt
Benckiser Pharmaceuticals Inc. (RBP).'' \1\ During that time, according
to the Information, RBP's Medical Affairs Manager, who reported
directly to Dr. Baxter, provided false or misleading analysis and
charts to the Massachusetts Medicaid program (MassHealth), as a means
of persuading MassHealth to

reimburse patients for a drug named Suboxone Film, which RBP marketed.
---------------------------------------------------------------------------

    \1\ As noted in the Information, ``on or about December 23,
2014, RBP was renamed Indivior, Inc, and became a subsidiary of
Indivior PLC. After on or about December 23, 2014, Dr. Baxter was
the Chief Medical Officer of Indivior PLC.''
---------------------------------------------------------------------------

    As framed by the Information, the false and misleading data and
analysis provided to MassHealth--relating to the unintended pediatric
exposure rates for Suboxone Film relative to similar tablet products--
constituted ``labeling'' for the drug under section 201(m) of the FD&C
Act (21 U.S.C. 321(m)) and thus misbranded the drug under section
502(a) of the FD&C Act). As discussed further below, in pleading guilty
pursuant to the Information, Dr. Baxter conceded that he was a
responsible corporate officer (RCO) at RBP that ``failed to prevent and
promptly correct the distribution of false and misleading unintended
pediatric exposure data and marketing claims to MassHealth'' and
``caused the introduction and delivery for introduction into interstate
commerce of . . . a drug [(Suboxone Film)] that was misbranded in that
the drug's labeling was false and misleading'' (see United States v.
Park, 421 U.S. 658, 673-74 (1975)).
    By letter dated February 25, 2021, FDA's Office of Regulatory
Affairs (ORA) notified Dr. Baxter of its proposal to debar him for 5
years from providing services in any capacity to a person having an
approved or pending drug product application and provided him with an
opportunity to request a hearing on the proposal. ORA found that Dr.
Baxter is subject to debarment under section 306(b)(2)(B)(i)(I) of the
FD&C Act on the basis of his misdemeanor conviction under Federal law
for conduct both relating to the regulation of a drug product under the
FD&C Act and undermining the Agency's process for regulating drugs. The
proposal also outlined findings concerning the factors ORA considered
to be applicable in determining the appropriateness and period of
debarment, as provided in section 306(c)(3) of the FD&C Act. ORA found
that a 5-year period of debarment is appropriate. Specifically, ORA
found that the nature and seriousness of the offense and the nature and
extent of voluntary steps to mitigate the effect on the public are
unfavorable factors for Dr. Baxter. ORA stated that it viewed the
absence of prior convictions involving matters within FDA's
jurisdiction as a favorable factor. ORA concluded that ``the facts
supporting the unfavorable factors outweigh those supporting the
favorable factor and therefore warrant the imposition of a 5-year
period of debarment.''
    By letter dated March 26, 2021, through counsel, Dr. Baxter
requested a hearing on ORA's proposal to debar him. On May 4, 2021, he
submitted a ``Memorandum of Facts and Arguments in Support of Hearing
Request'' (Memorandum). In this Memorandum, Dr. Baxter makes legal,
factual, and policy-based arguments regarding the proffered basis for
his debarment in ORA's proposal.
    Under the authority delegated to her by the Commissioner of Food
and Drugs, the Chief Scientist has considered Dr. Baxter's request for
a hearing. Hearings are granted only if there is a genuine and
substantial issue of fact. As discussed in more detail below, hearings
will not be granted on issues of policy or law, on mere allegations, on
denials or general descriptions of positions and contentions, on data
and information insufficient to justify the factual determination urged
if accurate and presented at a hearing, or on factual issues that are
not determinative with respect to the action requested (see Sec.
12.24(b) (21 CFR 12.24(b))). The Chief Scientist has considered Dr.
Baxter's arguments and concluded that they are unpersuasive and fail to
raise a genuine and substantial issue of fact requiring a hearing.

II. Arguments

    In his Memorandum, Dr. Baxter makes a series of legal and policy
arguments challenging whether he is subject to debarment and, if so,
whether debarment for 5 years is appropriate. Many of Dr. Baxter's
arguments are intertwined with his efforts to raise a genuine and
substantial issue of fact with respect to the findings in ORA's
proposal to debar him. Dr. Baxter's legal and factual arguments largely
turn on the extent to which the specific conduct underlying his
conviction subjects him to debarment under section 306(b)(2)(B)(i) of
the FD&C Act and the extent to which there are genuine and substantial
issues of fact with respect to ORA's findings under section
306(b)(2)(B)(i) and the applicable considerations under section
306(c)(3). In challenging the facts underlying ORA's findings and the
proposed period of debarment, Dr. Baxter contends that some of the
findings in ORA's proposal go beyond the facts to which he admitted
during the criminal proceedings and are demonstrably false.
Specifically, he disputes ORA's proposed findings: (1) that he ``helped
oversee [RBP's] efforts to secure formulary coverage for Suboxone Film
from [MassHealth]'' and a strategy to that end; (2) that his
misdemeanor offense involved the provision of false and misleading
information to MassHealth that included ``overstated safety claims'';
(3) that the conduct underlying his conviction ``put children at
risk.''
    In challenging those proposed findings, Dr. Baxter argues
extensively that he is entitled to a hearing because not only are there
genuine and substantial issues of fact with respect to them but they
are conclusory and do not appear to rest on substantial evidence. He
effectively contends, therefore, that he is entitled to a hearing on
those findings for further development and an opportunity to challenge
them. However, nothing in the relevant FDA regulations, section 306(i)
of the FD&C Act, or the Administrative Procedure Act (APA) (5 U.S.C.
551-559) requires more than an opportunity to raise genuine and
substantial issues of fact with respect to the findings in ORA's
proposal. As Dr. Baxter notes, section 306(i) of the FD&C Act requires
FDA to provide an ``opportunity for an agency hearing on disputed
issues of material fact'' before debarring any person. As noted by ORA
in its proposal, FDA implements adjudications required under section 5
U.S.C. 554(a), including debarment matters, as formal evidentiary
hearings under part 12 (21 CFR part 12).
    Under Sec.  12.24(b), consistent with the APA and case law, there
are criteria for granting a hearing. Pursuant to that regulation, the
Agency will grant a request for hearing only if the material submitted
in support of the hearing request shows, in relevant part: (1)
``[t]here is a genuine and substantial factual issue for resolution at
a hearing,'' (2) ``[t]he factual issue can be resolved by available and
specifically identified reliable evidence,'' (3) ``[t]he data and
information submitted, if established at a hearing, would be adequate
to justify resolution of the factual issue in the way sought by the
person,'' and (4) ``[r]esolution of the factual issue in the way sought
by the person is adequate to justify the action requested.'' The
regulation further clarifies that ``[a] hearing will not be granted on
issues of policy or law'' and that ``a hearing will not be granted on
factual issues that are not determinative with respect to the action
requested.''
    The factual challenges in Dr. Baxter's Memorandum, such as whether
his conduct put children at risk, do not justify granting his hearing
request. Dr. Baxter appears to acknowledge, as he must, that the facts
to which he pled guilty--i.e., the findings of the court that entered a
criminal judgment against him--are not in dispute. Dr. Baxter's
arguments highlighting those findings by ORA that go beyond the facts
to which he admitted as part of his guilty plea do not create a genuine
and

substantial issue of fact, nor are those findings determinative with
respect to whether Dr. Baxter is subject to debarment and whether a
debarment period of 5 years is appropriate. For reasons discussed in
detail below, it is not necessary to go beyond the facts to which Dr.
Baxter pled guilty and the other undisputed facts in ORA's proposal to
conclude that Dr. Baxter is subject to debarment under section
306(b)(2)(B)(i) of the FD&C Act and that debarment for 5 years is
appropriate under section 306(c)(3).
    For the sake of simplicity and efficiency, what follows is an
assessment of Dr. Baxter's legal, factual, and policy-based arguments
by reference only to the facts to which he pled guilty or the other
undisputed findings in ORA's proposal.

A. Dr. Baxter Is Subject to Debarment

    Dr. Baxter first argues that he is not subject to debarment under
section 306(b)(2)(B)(i) of the FD&C Act. Dr. Baxter maintains that a
misdemeanor conviction for causing the introduction of a misbranded
drug into interstate commerce under the Responsible Corporate Officer
(RCO) doctrine is ``not sufficient to impose debarment'' and that his
criminal conduct lacks a sufficient nexus to ``the regulation of drug
products'' under the FD&C Act. Dr. Baxter contends that his conduct
does not undermine the process for the regulation of drugs and that,
because the drug product at issue had already received FDA approval,
the misleading communication at issue did not relate to the approval or
the approval process. In support of these arguments, he points to the
legislative history of section 306 of the FD&C Act:

    As the House Report to H.R. 2454 explains, this section ``gives
FDA the authority to debar a person . . . for conduct relating to
the development or approval of generic drugs.'' In addition
``[c]onviction of certain other crimes, such as bribery, fraud, and
obstruction of justice, could also be the basis for debarment''
because the seriousness of those crimes undermines the
trustworthiness of the individual, such a conviction ``provide[s]
evidentiary support for a finding that the individual should not be
allowed to submit or assist in the submission of a generic drug
application even though the crime did not directly involve the
approval process'' [emphasis removed]. Thus, there is no indication
that Congress intended to make any conviction under Title 21 grounds
for permissive debarment, regardless of whether or not the conduct
had anything to do with the drug approval process or fraud or
similarly serious offenses.

    Dr. Baxter contends that ``the legislative history makes clear that
conduct that `undermines the process for the regulation of drugs' is
conduct that either undermines the approval process itself or
constitutes such egregious fraud that it supports the conclusion that
the individual can never be trusted to participate in the
pharmaceutical industry'' (emphases removed). Finally, Dr. Baxter
argues that ORA's finding that his conduct was of a type that
undermines the process for the regulation of drugs is unsupported
because, while it was ``technical misbranding,'' there was never any
harm or risk to the public.
    Section 306(b)(2)(B)(i) of the FD&C Act specifically provides for
debarring individuals convicted of Federal misdemeanors related to the
regulation of drug products. If the language of the statute is clear,
there is no need to look outside the statute to its legislative history
in order to ascertain the statute's meaning (Chamber of Commerce of
United States v. Whiting, 563 U.S. 582, 599 (2011)). Furthermore, as
the Supreme Court has repeatedly held, the language in the FD&C Act
should be construed in a manner that is consistent with its overall
public health purpose. When we are dealing with the public health, the
language of the FD&C Act should not be read too restrictively, but
rather as ``consistent with the Act's overriding purpose to protect the
public health'' (United States v. Article of Drug Bacto-Unidisk, 394
U.S. 784, 798 (1969)).
    Dr. Baxter's general argument that the conduct underlying his
conviction lacks a sufficient nexus to the regulation of drugs to
subject him to debarment under section 306(b)(2)(B)(i)(I) of the FD&C
Act lacks merit. Simply put, he pled guilty to causing the introduction
of a misbranded drug into interstate commerce in violation of the FD&C
Act (specifically, sections 301(a), 303(a)(1), and 502(a) of the FD&C
Act). In section 306(b)(2)(B)(i)(I), ``a misdemeanor under Federal law
or a felony under State law for conduct . . . otherwise relating to the
regulation of drug products'' subjects an individual to permissive
debarment. There are no genuine and substantial issues of fact
regarding whether Dr. Baxter pled guilty to--and therefore committed--a
misdemeanor under Federal law. When that Federal misdemeanor is for
conduct that directly violated the FD&C Act with respect to drug
labeling, there is no question that such violation relates to the
regulation of drugs under that statutory authority.
    Dr. Baxter makes many similar arguments with respect to whether the
conduct to which he pled guilty as part of his misdemeanor plea is
``the type of conduct [that] . . . undermines the process for the
regulation of drugs'' under the FD&C Act in the sense contemplated by
section 306(b)(2)(B)(i)(I) of the FD&C Act. In doing so, he attempts to
distinguish between conduct relating to the development and approval
process for drug products and conduct relating to other aspects of drug
regulation under the FD&C Act. Although he supports that distinction by
pointing to the legislative history of section 306 and offering policy
arguments, neither section 306(b)(2)(B)(i)(I) nor the FD&C Act as a
whole bear out that distinction. The plain language of section
306(b)(2)(B)(i)(I) does not draw the distinction urged by Dr. Baxter
and indeed expands the scope of the statutory provision beyond conduct
relating to the development and approval process by including the
language ``otherwise relating to the regulation of drug products.''
With respect to the purpose of FD&C Act as a whole, the Supreme Court
has found that its aims go well beyond the development and approval
process for drug products: ``Its purpose [is] to safeguard the consumer
by applying the Act to articles from the moment of their introduction
into interstate commerce all the way to the moment of their delivery to
the ultimate consumer'' (United States v. Sullivan, 332 U.S. 689, 696
(1948)).
    The Chief Scientist also rejects Dr. Baxter's further arguments
that he is not subject to debarment under section 306(b)(2)(B)(i)(I) of
the FD&C Act because he pled guilty to a Federal misdemeanor offense
without admitting any intent to violate the law or knowledge of
wrongdoing and because the underlying offense did not involve ``fraud,
bribery, [or] similar crimes.'' Given that section 306(b)(2)(B)(i) of
the FD&C Act explicitly permits debarring individuals convicted of
Federal misdemeanors related to the regulation of drug products and
that a misdemeanor violation of the FD&C Act itself is a strict
liability offense under section 303(a)(1) of the FD&C Act, it stands to
reason that criminal intent is not required to subject an individual to
debarment under section 306(b)(2)(B)(i)(I). As ORA correctly
determined, however, his conduct went beyond a mere technical violation
of the FD&C Act:

    [Dr. Baxter's] actions undermined the process for the regulation
of drugs because [he] failed to prevent [RBC] from sending false and
misleading data and information to MassHealth related to the rate of
unintended pediatric exposure to Suboxone Film and did not promptly
correct such information and data.

    Indeed, the Information to which Dr. Baxter pled guilty provided
that he, ``as a responsible [RBP] executive failed to prevent and
promptly correct the distribution of the false and misleading
unintended pediatric exposure data and marketing claims to MassHealth''
and that, accordingly, he caused the introduction and delivery for
introduction of a misbranded drug into interstate commerce. He cannot
now hide behind his arguments that he lacked specific knowledge that
the labeling for the Suboxone Film was false and misleading in an
attempt to overcome the debarment resulting from the facts to which he
admitted as part of his plea agreement. As the Supreme Court has
reasoned, in keeping with the FD&C Act's purpose of protecting the
public from adulterated and misbranded products, Congress chose to
place the burden of protecting the public on those who play a role in
manufacturing and distributing those products rather than on consumers,
who cannot protect themselves (United States v. Dotterweich, 320 U.S.
277, 280-81 (1943)). The duty imposed on RCOs ``requires the highest
standard of foresight and vigilance'':

    The requirements of foresight and vigilance imposed on
responsible corporate agents are beyond question demanding, and
perhaps onerous, but they are no more stringent than the public has
a right to expect of those who voluntarily assume positions of
authority in business enterprises whose services and products affect
the health and well-being of the public that supports them (Park,
421 U.S. at 672-73).

    The type of conduct to which Dr. Baxter pled guilty failed to meet
the duty imposed on RCOs and undermined the process for the regulation
of drugs in the sense contemplated by both section 306(b)(2)(B)(i)(I)
and the FD&C Act as a whole.
    In light of the foregoing, the Chief Scientist has found that Dr.
Baxter has failed to raise a genuine and substantial issue of fact with
respect to: (1) whether the conduct serving as the basis of his Federal
misdemeanor conviction related to the regulation of drugs and is the
type of conduct that undermines the process for the regulation of drugs
and thus (2) whether he is subject to debarment under the terms of
section 306(b)(2)(B)(i)(I) of the FD&C Act.

B. Appropriateness of a 5-Year Debarment Period

    In support of his hearing request, Dr. Baxter further argues in his
Memorandum that he is entitled to a hearing on ORA's findings with
respect to the considerations in section 306(c)(3) of the FD&C Act. Dr.
Baxter contends that ORA's assessment of the nature and seriousness of
his offense and the nature and extent of voluntary steps to mitigate
the impact on the public were based on errors of fact, logic, and law.
Dr. Baxter also argues that ORA's proposal gave insufficient weight to
the third factor, his lack of prior convictions involving matters
within the jurisdiction of FDA. Additionally, Dr. Baxter challenges the
appropriateness of the proposed 5-year debarment period.
    Dr. Baxter first challenges ORA's assessment of the nature and
seriousness of his offense under section 306(c)(3)(A) of the FD&C Act.
Yet, as ORA found and has been discussed at length above, Dr. Baxter
took responsibility for RBP's introducing, and delivering for
introduction, a misbranded drug into interstate commerce. Dr. Baxter
admitted as part of his guilty plea that he was in a position both to
prevent the violations resulting from his subordinate's conduct--i.e.,
the inclusion of false and misleading information in the labeling for
Suboxone Film--or to correct them promptly. But he did not. Building on
the reasoning above with respect to whether the type of conduct serving
as the basis of Dr. Baxter's misdemeanor conviction undermined the
process for the regulation of drugs, the Chief Scientist finds that Dr.
Baxter's role and responsibility in the introduction of a drug whose
labeling and false and misleading under section 502(a) of the FD&C
Act--especially when the labeling at issue went directly to a State
Medicaid agency and when viewed within the range of potential
misdemeanor convictions that might subject an individual to permissive
debarment under section 306(b)(2)(B)(i)(I) of the FD&C Act--is
sufficiently serious to warrant treatment as an unfavorable factor. In
short, Dr. Baxter has failed to raise a genuine and substantial issue
of fact with respect to ORA's findings regarding the nature and
seriousness of his offense under section 306(c)(3)(A) of the FD&C Act.
    Dr. Baxter next argues that, in evaluating ``the nature and extent
of voluntary steps to mitigate the impact of any offense involved''
under section 306(c)(3)(C) of the FD&C Act, ORA did not fully consider
that there was no negative impact on the public to mitigate and that he
nonetheless did play a role in sending a correction letter to
MassHealth. Specifically, Dr. Baxter maintains that he could not have
taken any action prior to the Federal government's investigation into
the matter because he was not aware of the wrongful conduct. Finally,
Dr. Baxter also contends that ORA ``ignored that Dr. Baxter accepted
responsibility for his violation and agreed to cooperate with the
Government, as evidenced by the plea agreement.''
    The facts to which Dr. Baxter pled guilty belie his arguments now
that any role he played in correcting his violations should be
construed as a voluntary step taken in mitigation in the sense
contemplated by section 306(c)(3)(C) of the FD&C Act. As part of his
guilty plea, he admitted that he was an RCO ``with authority to either
prevent in the first instance or to promptly correct the provision of
false and misleading information to MassHealth and that he took neither
action.'' He cannot now claim that his corrective action was
sufficiently prompt to be meaningful, and he does not dispute that he
directed the correction ``only after an investigation was opened into
this matter.'' Dr. Baxter states that ORA's proposal does not ``suggest
there was any other action that Dr. Baxter could have or should have
done to `mitigate the impact to the public.' '' He does not, however,
present any reason to believe that he took additional steps to mitigate
the effect of his offense on the public. Additionally, Dr. Baxter's
guilty plea does not qualify as a voluntary step to mitigate the impact
of his offense on the public under section 306(c)(3)(C) of the FD&C
Act. Accordingly, the Chief Scientist finds that Dr. Baxter has failed
to raise a genuine and substantial issue of fact with respect to ORA's
findings regarding the voluntary steps taken by him to mitigate the
effect of his offense on the public under section 306(c)(3)(C) of the
FD&C Act.
    Based on the undisputed record before me, primarily encompassing
the facts to which Dr. Baxter pled guilty, the Chief Scientist finds
that a 5-year debarment is appropriate. Although Dr. Baxter has no
previous criminal convictions related to matters within the
jurisdiction of FDA, this sole favorable factor does not counterbalance
the nature and seriousness of his offense and lack of voluntary steps
promptly taken to mitigate the effect of that offense on the public. As
has been discussed at length, Dr. Baxter admitted as part of his guilty
plea that, as an RCO, he possessed the authority, opportunity, and
responsibility to prevent or promptly correct conduct that caused false
and misleading information to go to a State Medicaid agency and thereby
caused the introduction of a misbranded drug into interstate commerce.
His failure to prevent or promptly correct conduct breached the
fundamental responsibility as an RCO when he

voluntarily assumed a ``position of authority in [a] business
enterprise whose services and products affect the health and well-being
of the public'' (Park, 421 U.S. at 573). In short, the Chief Scientist
agrees with ORA's conclusion in its proposal that ``the facts
supporting the unfavorable factors outweigh those supporting the
favorable factor, and therefore warrant the imposition of a 5-year
period of debarment.''

C. Remaining Legal Arguments

    Finally, Dr. Baxter argues that debarring him for 5 years would be
arbitrary and capricious and an abuse of discretion. Dr. Baxter
contends that debarment is a remedial measure and that his conduct is
``untethered'' to that remedial purpose because his conduct did not
undermine confidence in the drug approval process and thus ``makes the
deterrence value of any debarment practically nonexistent--and
potentially harmful.'' Additionally, he argues that his one conviction
does not warrant debarment. Dr. Baxter also argues that debarment would
be arbitrary and capricious because FDA has not previously debarred an
individual in a ``pure'' RCO case. Finally, Dr. Baxter contends that
debarring him for the maximum period would be arbitrary and capricious
because his conduct differs in meaningful ways from that of others who
received 5-year debarments.
    As is extensively discussed above, however, Dr. Baxter did not
plead guilty based purely on strict liability. He admitted as part of
his guilty plea that he was an RCO ``with authority to either prevent
in the first instance or to promptly correct the provision of false and
misleading information to MassHealth and that he took neither action.''
(see Park, 421 U.S. at 673-74). As discussed above, Dr. Baxter's role
at RBP and his conviction as an RCO does not lessen the seriousness of
the conviction or underlying conduct but instead elevates it to a
higher level of concern given his role within the company.
    As Dr. Baxter notes, FDA's debarment authority is a remedial
measure, and not a punitive one, and a tool to protect the public
health (see generally DiCola v. Food and Drug Admin., 77 F.3d 504 (D.C.
Cir. 1996); Bhutani v. U.S. Food and Drug Admin., 161 F. App'x 589, 593
(7th Cir. 2006)). As explained extensively above, Dr. Baxter's conduct
significantly undermined the process for the regulation of drugs.
Therefore, his conduct is not ``untethered'' to the remedial purpose of
debarment; rather, his conduct fits squarely into the category of
conduct that warrants debarment under section 306(b)(2)(B)(i)(I) of the
FD&C Act. While Dr. Baxter contends that his conduct does not require
any additional remedial measures, his arguments to that effect ignore
that the conduct underlying his conviction calls into question whether,
when in a position to prevent or promptly correct violations of the
FD&C Act, he would do so and thus uphold the protections to public
health afforded by that statute.
    Based on Dr. Baxter's arguments and the case law he cites, he
appears to be relying on the judicial standard for review of Agency
decision-making in the APA at 5 U.S.C. 706(2), which directs courts to
``hold unlawful and set aside agency action[s]'' that are ``arbitrary,
capricious, an abuse of discretion, or otherwise not in accordance with
law.'' As the Supreme Court has held, the question under that standard
is whether the Agency has provided a reasonable explanation for the
substance its decision:

    The APA's arbitrary-and-capricious standard requires that agency
action be reasonable and reasonably explained. Judicial review under
that standard is deferential, and a court may not substitute its own
policy judgment for that of the agency. A court simply ensures that
the agency has acted within a zone of reasonableness and, in
particular, has reasonably considered the relevant issues and
reasonably explained the decision (FCC v. Prometheus Radio Project,
141 S. Ct. 1150, 1158, 209 L. Ed. 2d 287 (2021)).

    In this matter, as reflected in the lengthy discussion above, the
Agency has reasonably considered the relevant issues and fully
explained its decision to debar Dr. Baxter.
    Although Dr. Baxter points to other individuals who pled guilty to
misdemeanors based on liability as RCOs and who have not been debarred,
he provides no details with respect to those individuals' convictions.
Even assuming, however, that those individuals were similarly situated
to him, his bare assertion that an agency cannot choose to begin
pursuing debarment of individuals for certain discrete categories of
Federal misdemeanor convictions because it has not done so in the past
is unfounded.
    Dr. Baxter further argues, however, that the Agency has debarred
other individuals for less than 5 years when it was undisputed that
those individuals did not act with knowledge or intent in violating the
FD&C Act. For example, Dr. Baxter specifically points to a doctor who
was a principal in a medical practice who unknowingly used an
unapproved product on patients while representing that it was an FDA-
approved product (see generally Douglas M. Hargrave Denial of Hearing;
Final Debarment Order, 80 FR 11995 (March 5, 2015)). As Dr. Baxter
notes, FDA debarred Dr. Hargrave for 2 years instead of 5 years.
However, unlike Dr. Hargrave Dr. Baxter explicitly admitted during his
criminal proceedings that he was in a position of authority that should
have enabled him to prevent or promptly correct the violative conduct.
    As discussed, in terms of section 306(b)(2)(B)(i)(I) and 306(c)(3)
of the FD&C Act are clear, and the Agency has exercised its discretion
here in a manner consistent with the permissive debarment of many other
individuals convicted of Federal misdemeanors related to the regulation
of drugs. Accordingly, Dr. Baxter's argument that debarring him is
arbitrary, capricious, and contrary to law lacks merit.

III. Findings and Order

    Therefore, the Chief Scientist, under section 306(b)(2)(B)(i)(I) of
the FD&C Act and under authority delegated to her by the Commissioner
of Food and Drugs, finds that: (1) Dr. Baxter has been convicted of a
misdemeanor under Federal law for conduct relating to the development
or approval, including the process for development or approval, of a
drug product or otherwise relating to the regulation of a drug product
under the FD&C Act and (2) the type of conduct which served as the
basis for the conviction undermines the process for the regulation of
drugs. FDA has considered the applicable factors listed in section
306(c)(3) of the FD&C Act and determined that a debarment of 5 years is
appropriate.
    As a result of the foregoing findings, Dr. Baxter is debarred for 5
years from providing services in any capacity to a person with an
approved or pending drug product application under section 505, 512, or
802 of the FD&C Act (21 U.S.C. 355, 360b, or 382), or under section 351
of the Public Health Service Act (42 U.S.C. 262), effective February
27, 2023 (see 21 U.S.C. 335a(c)(1)(B) and (c)(2)(A)(iii) and 21 U.S.C.
321(dd)). Any person with an approved or pending drug product
application, who knowingly uses the services of Dr. Baxter, in any
capacity during his period of debarment, will be subject to civil money
penalties (section 307(a)(6) of the FD&C Act (21 U.S.C. 335b(a)(6))).
If Dr. Baxter, during his period of debarment, provides services in any
capacity to a person with an approved or pending drug product
application, he will be subject to civil money penalties (section
307(a)(7) of the FD&C Act). In addition, FDA will not accept or review
any abbreviated new drug applications

submitted by or with the assistance of Dr. Baxter during his period of
debarment (section 306(c)(1)(B) of the FD&C Act).

    Dated: February 21, 2023.
Namandj[eacute] N. Bumpus,
Chief Scientist.
[FR Doc. 2023-03946 Filed 2-24-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 88, Number 71 (Thursday, April 13, 2023)]
[Notices]
[Pages 22457-22459]
[FR Doc No: 2023-07769]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-3546]

Assessing the Irritation and Sensitization Potential of
Transdermal and Topical Delivery Systems for ANDAs; Revised Draft
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a revised draft guidance for industry entitled
``Assessing the Irritation and Sensitization Potential of Transdermal
and Topical Delivery Systems for ANDAs.'' This revised draft guidance
provides recommendations for the design and conduct of studies to
evaluate the in vivo skin irritation and sensitization (I/S) potential
of a proposed transdermal or topical delivery system (collectively
referred to as TDS). The recommendations in this revised draft guidance
relate to studies submitted in support of an abbreviated new drug
application (ANDA). The revised draft guidance is intended to clarify
FDA's recommendations and expectations related to in vivo skin I/S
studies. This guidance revises the October 2018 draft guidance entitled
``Assessing the Irritation and Sensitization Potential of Transdermal
and Topical Delivery Systems for ANDAs.''

DATES: Submit either electronic or written comments on the draft
guidance by June 12, 2023 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2018-D-3546 for ``Assessing the Irritation and Sensitization
Potential of Transdermal and Topical Delivery Systems for ANDAs.''
Received comments will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Melissa Mannion, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1611, Silver Spring, MD 20993-0002, 301-
796-2747.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a revised draft guidance for
industry entitled ``Assessing the Irritation and Sensitization
Potential of Transdermal and Topical Delivery Systems for ANDAs.'' This
guidance revises the draft guidance entitled ``Assessing the Irritation
and Sensitization Potential of Transdermal and Topical Delivery Systems
for ANDAs'' that was published in the Federal Register on October 10,
2018 (83 FR 50945). FDA received eight comments on the draft guidance,
which were considered before publication of this revised draft
guidance.
    The components and composition of a TDS formulation, including the
nature of the drug substance and/or the occlusivity of the TDS
materials, in conjunction with other factors such as the environmental
humidity or the condition of the skin, may have the potential to
irritate the skin or lead to a sensitization reaction. Such reactions
can be unpleasant to the patient and may affect patient compliance,
skin permeability, and/or adhesion of the TDS to the skin. The
collective consequence of these potential effects could create
uncertainty about the resulting drug delivery profile and uncertainty
about the rate and extent of drug absorption from the TDS. Therefore,
when appropriate, applicants should perform a comparative assessment of
the test (T) and reference

(R) TDS products using an appropriately designed skin I/S study with
human subjects to demonstrate that the potential for a skin irritation
or sensitization reaction with the T TDS is no worse than the reaction
observed with the R TDS.
    This revised draft guidance provides the following updates to the
original draft guidance:
    (1) Clarifies recommendations for the design and conduct of studies
to evaluate the in vivo skin I/S potential of a proposed TDS.
    (2) Clarifies when an in vivo study to assess the sensitization
potential of a TDS product may not be needed.
    (3) Provides guidance to applicants intending to utilize
alternative scoring scales or alternative approaches to compare
irritation and sensitization between the T and R TDS.
    The recommendations in this revised draft guidance relate to
studies submitted in support of an ANDA. The Agency is seeking comments
on the recommendations reflected in the revised draft guidance
announced in this notice. In addition, FDA invites comments on the
scoring scales and any alternative approaches, including those
recommended by international regulatory agencies, that may have been
used for the comparative assessment of the I/S potential for proposed
generic TDS products. FDA also specifically invites comments regarding
the comparative assessment of sensitization itself, i.e., whether there
are clinical scenarios where a comparative sensitization assessment may
be uninformative when conducted in addition to a comparative irritation
assessment.
    This revised draft guidance is being issued consistent with FDA's
good guidance practices regulation (21 CFR 10.115). The draft guidance,
when finalized, will represent the current thinking of FDA on
``Assessing the Irritation and Sensitization Potential of Transdermal
and Topical Delivery Systems for ANDAs.'' It does not establish any
rights for any person and is not binding on FDA or the public. You can
use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this revised draft guidance contains no collection of
information, it does refer to previously approved FDA collections of
information. Therefore, clearance by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C.
3501-3521) is not required for this guidance. The previously approved
collections of information are subject to review by OMB under the PRA.
The collections of information in 21 CFR part 314 relating to the
submission of abbreviated new drug applications have been approved
under OMB control number 0910-0001. The collections of information
relating to good clinical practice have been approved under OMB control
number 0910-0843.

III. Electronic Access

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

    Dated: April 7, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-07769 Filed 4-12-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 81, Number 228 (Monday, November 28, 2016)]
[Notices]
[Page 85554]
[FR Doc No: 2016-28465]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice Of Filings #2

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER11-1844-003.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Report Filing: 2016-11-21_Submittal of refund report
related to ITC PARs Order to be effective N/A.
    Filed Date: 11/21/16.
    Accession Number: 20161121-5141.
    Comments Due: 5 p.m. ET 12/12/16.

    Docket Numbers: ER17-55-001.
    Applicants: South Carolina Electric & Gas Company.
    Description: Compliance filing: Order Nos 827 and 828 Attachment N
to be effective 10/14/2016.
    Filed Date: 11/21/16.
    Accession Number: 20161121-5059.
    Comments Due: 5 p.m. ET 12/12/16.

    Docket Numbers: ER17-90-001.
    Applicants: Public Service Company of Colorado.
    Description: Compliance filing: Order 827 and 828 Compliance
Amendment to be effective 10/14/2016.
    Filed Date: 11/21/16.
    Accession Number: 20161121-5061.
    Comments Due: 5 p.m. ET 12/12/16.

    Docket Numbers: ER17-396-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Tariff Cancellation: Notice of Cancellation of WMPA SA
No. 2933, Queue No. W2-076 to be effective 1/17/2017.
    Filed Date: 11/21/16.
    Accession Number: 20161121-5060.
    Comments Due: 5 p.m. ET 12/12/16.

    Docket Numbers: ER17-397-000.
    Applicants: Pacific Wind Lessee, LLC.
    Description: Sec.  205(d) Rate Filing: Revised Shared Transmission
Facilities Agreement & Request for Waiver to be effective 9/14/2016.
    Filed Date: 11/21/16.
    Accession Number: 20161121-5097.
    Comments Due: 5 p.m. ET 12/12/16.

    Docket Numbers: ER17-398-000.
    Applicants: Westar Energy, Inc.
    Description: Sec.  205(d) Rate Filing: Ironwood Certificate of
Concurrence for Amended and Restated Sub. Use Agreement to be effective
12/23/2016.
    Filed Date: 11/21/16.
    Accession Number: 20161121-5114.
    Comments Due: 5 p.m. ET 12/12/16.

    Docket Numbers: ER17-399-000.
    Applicants: Midcontinent Independent System Operator, Inc., Duke
Energy Indiana, LLC.
    Description: Sec.  205(d) Rate Filing: 2016-11-21_SA 2285 Duke
Energy-AEP WDS (Hagerstown) to be effective 2/1/2017.
    Filed Date: 11/21/16.
    Accession Number: 20161121-5137.
    Comments Due: 5 p.m. ET 12/12/16.

    Docket Numbers: ER17-400-000.
    Applicants: Kelly Creek Wind, LLC.
    Description: Sec.  205(d) Rate Filing: Filing of Kelly Creek Rate
Schedule FERC No. 1 re Reactive Power Compensation to be effective 2/1/
2017.
    Filed Date: 11/21/16.
    Accession Number: 20161121-5184.
    Comments Due: 5 p.m. ET 12/12/16.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: November 21, 2016.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2016-28465 Filed 11-25-16; 8:45 am]
 BILLING CODE 6717-01-P