[Federal Register Volume 78, Number 25 (Wednesday, February 6, 2013)]
[Notices]
[Pages 8600-8601]
[FR Doc No: 2013-02568]

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SECURITIES AND EXCHANGE COMMISSION

Submission for OMB Review; Comment Request

Upon Written Request Copies Available From: Securities and Exchange
Commission, Office of Investor Education and Advocacy, Washington, DC
20549-0213.

Extension:
    Schedule 13E-4F; OMB Control No. 3235-0375, SEC File No. 270-
340.

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') has submitted to the Office of Management
and Budget this request for extension of the previously approved
collection of information discussed below.

    Schedule 13E-4F (17 CFR 240.13e-102) may be used by an issuer that
is incorporated or organized under the laws of Canada to make a cash
tender or exchange offer for the issuer's own securities if less than
40 percent of the class of such issuer's securities outstanding that
are the subject of the tender offer is held by U.S. holders. The
information collected must be filed with the Commission and is publicly
available. We estimate that it takes approximately 2 hours per response
to prepare Schedule 13E-4F and that the information is filed by
approximately 3 respondents annually for a total annual reporting
burden of 6 hours (2 hours per response x 3 responses).
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid control number.
    The public may view the background documentation for this
information collection at the following Web site, www.reginfo.gov.
Comments should be directed to: (i) Desk Officer for the Securities and
Exchange Commission, Office of Information and Regulatory Affairs,
Office of Management and Budget, Room 10102, New Executive Office
Building, Washington, DC 20503, or by sending an email to<EMAIL_ADDRESS>and (ii) Thomas Bayer, Director/Chief Information
Officer, Securities and Exchange Commission, c/o Remi Pavlik-Simon,
6432 General Green Way, Alexandria, VA 22312 or send an email to<EMAIL_ADDRESS>Comments must be submitted to OMB within 30 days of
this notice.

    Dated: January 31, 2013.
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-02568 Filed 2-5-13; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 86, Number 42 (Friday, March 5, 2021)]
[Proposed Rules]
[Pages 12892-12895]
[FR Doc No: 2021-04406]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 81

[EPA-R04-OAR-2020-0482; FRL-10019-57-Region 4]

Air Plan Approval; TN: Redesignation of the Sumner County 2010
Sulfur Dioxide Unclassifiable Area

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve a State Implementation Plan (SIP) revision submitted by the
State of Tennessee, through the Tennessee Department of Environment and
Conservation (TDEC), on September 29, 2020, to redesignate the Sumner
County, Tennessee unclassifiable area (hereinafter referred to as the
``Sumner County Area'' or ``Area'') to attainment/unclassifiable for
the 2010 1-hour primary sulfur dioxide (SO2) national
ambient air quality standard (hereinafter referred to as the ``2010
SO2 1-hour NAAQS''). EPA now has sufficient information to
determine that the Sumner County Area is attaining the 2010 1-hour
SO2 NAAQS and, therefore, is proposing to approve the
State's request and redesignate the Area to attainment/unclassifiable
for the 2010 1-hour SO2 NAAQS.

DATES: Comments must be received on or before April 5, 2021.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R04-
OAR-2020-0482 at http://www.regulations.gov. Follow the online
instructions for submitting comments. Once submitted, comments cannot
be edited or removed from Regulations.gov. 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, the full EPA public comment
policy, information about CBI or multimedia submissions, and general
guidance on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Evan Adams, Air Regulatory Management
Section, Air Planning and Implementation Branch, Air and Radiation
Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth
Street SW, Atlanta, Georgia 30303-8960. Mr. Adams can be reached by
telephone at<PHONE_NUMBER> or via electronic mail at
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    The Clean Air Act (CAA or Act) establishes a process for air
quality management through the establishment and implementation of the
national ambient air quality standards (NAAQS). On June 2, 2010, EPA
revised the primary SO2 NAAQS, establishing a new 1-hour
SO2 standard of 75 parts per billion (ppb). See 75 FR 35520
(June 22, 2010).\1\ After the promulgation of a new or revised NAAQS,
EPA is required to designate all areas of the country, pursuant to
section 107(d)(1)-(2) of the CAA. For the 2010 1-hour SO2
NAAQS, designations were based on EPA's application of the nationwide
analytical approach to, and technical assessment of, the weight of
evidence for each area, including but not limited to available air
quality monitoring data and air quality modeling results. In advance of
designating the Sumner County Area, EPA issued updated designations
guidance through a March 20, 2015, memorandum from Stephen D. Page,
Director, U.S. EPA, Office of Air Quality Planning and Standards, to
Air Division Directors, U.S. EPA Regions 1-10 titled, ``Updated
Guidance for Area Designations for the 2010 Primary Sulfur Dioxide
National Ambient Air Quality Standard,'' which contained the

factors that EPA evaluated in determining the appropriate designations
and associated boundaries when designating the Sumner County Area,
including: (1) Air quality characterization via ambient monitoring or
dispersion modeling results; (2) emissions-related data; (3)
meteorology; (4) geography and topography; and (5) jurisdictional
boundaries.2 3 The guidance also referenced EPA's non-
binding Monitoring Technical Assistance Document (Monitoring TAD) and
Modeling Technical Assistance Document (Modeling TAD),\4\ which contain
scientifically sound recommendations on how air agencies should conduct
such monitoring or modeling.
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    \1\ On February 25, 2019 (effective April 17, 2019), based on a
review of the full body of currently available scientific evidence
and exposure/risk information, EPA issued a decision to retain the
existing NAAQS for SO2. See 84 FR 9866.
    \2\ The 2015 memorandum is available at https://www.epa.gov/sites/production/files/2016-04/documents/20150320so2designations.pdf.
    \3\ This designation guidance has since been supplemented by a
July 22, 2016, designation guidance memorandum from Stephen D. Page,
Director, U.S. EPA, Office of Air Quality Planning and Standards, to
Regional Air Division Directors, U.S. EPA Regions 1-10. The 2016
memorandum is available at https://www.epa.gov/sites/production/files/2016-07/documents/areadesign.pdf.
    \4\ ``Sulfur Dioxide (SO2) National Ambient Air
Quality Standards Designations Modeling Technical Assistance
Document,'' August 2016 draft, available at https://www.epa.gov/sites/production/files/2016-06/documents/so2modelingtad.pdf. EPA
released earlier drafts of this document in May 2013 and February
2016.
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    EPA completed the first set of initial area designations for the
2010 1-hour SO2 NAAQS in 2013 (Round 1). Pursuant to a March
2, 2015, consent decree and court-ordered schedule,\5\ EPA finalized a
second set of initial area designations for the 2010 1-hour
SO2 NAAQS in 2016 (Round 2). The March 2, 2015, consent
decree identified the following emissions criteria such that EPA must
designate, in Round 2, an area surrounding any stationary source which
had: (a) annual emissions in 2012 exceeding 16,000 tons of
SO2, or (b) both an annual average emissions rate of at
least 0.45 pounds of SO2 per one million British thermal
units, according to EPA's Clean Air Markets Division Database, and
annual emissions of at least 2,600 tons of SO2 in 2012.
Sumner County, Tennessee contained one source, Tennessee Valley
Authority (TVA) Gallatin Fossil Plant (TVA Gallatin), that met these
Round 2 criteria. EPA evaluated the Area, using the five factors
identified previously, during the Round 2 designations. This evaluation
is discussed further in Section III of this notice. TVA Gallatin is
located in north-central Tennessee in the southern portion of Sumner
County, approximately 5 kilometers (km) southeast of the center of
Gallatin, Tennessee. TVA Gallatin is a large Electric Generating Unit
that was included in the list of facilities to be designated pursuant
to the March 2, 2015, Consent Decree.6 7
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    \5\ See Sierra Club et. al. v. McCarthy, Civil Action No. 3:13-
cv-3953-SI (N.D. Cal.), and 79 FR 31325 (June 2, 2014).
    \6\ TVA Gallatin was also subject to EPA's 2015 Data
Requirements Rule (DRR) for the 2010 SO2 1-hour NAAQS.
See https://www.epa.gov/sites/production/files/2016-06/documents/tn.pdf for Tennessee's letter dated January 15, 2016 with the Data
Requirements Rule (DRR) source list.
    \7\ In accordance with the DRR, 40 CFR part 51, subpart BB,
through a letter dated June 7, 2016, Tennessee notified EPA that the
State chose to characterize peak 1-hour SO2
concentrations for TVA Gallatin using air quality dispersion
modeling.
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    EPA's March 20, 2015, guidance specified the designation category
definitions to be used in the Round 2 designations. Specifically, EPA
defined a ``nonattainment'' area as an area that EPA has determined
violates the 2010 1-hour SO2 NAAQS based on the most recent
three years of quality-assured, certified ambient air quality
monitoring data or an appropriate modeling analysis, or that EPA has
determined contributes to a violation in a nearby area; and defined an
``attainment'' area as an area that EPA has determined meets the 2010
1-hour SO2 NAAQS and does not contribute to a violation of
the NAAQS in a nearby area based on either: (a) the most recent 3 years
of ambient air quality monitoring data from a monitoring network in an
area that is sufficient to be compared to the NAAQS per EPA
interpretations in the Monitoring TAD, or (b) an appropriate modeling
analysis. As discussed further in Section III of this notice, EPA was
unable to determine whether the Sumner County Area met the definition
of a nonattainment area or the definition of an attainment area based
on the available information at the time of the Round 2 designations.
As a result, EPA designated the Sumner County Area as unclassifiable in
the Round 2 designations published on July 12, 2016.\8\ The boundary
for this designation was the jurisdictional boundary of Sumner County.
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    \8\ See 81 FR 45039 (July 12, 2016), codified at 40 CFR 81.343.
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    Detailed rationale, analyses, and other information supporting
EPA's original Round 2 designation for this Area can be found in the
Round 2 designation's technical support document (TSD) for Tennessee.
That TSD, along with all other supporting materials for the original
2010 1-hour SO2 NAAQS designation for Sumner County, can be
found on EPA's SO2 designations website.\9\ In support of
this proposed redesignation action, EPA evaluated new modeling for the
Sumner County Area provided by Tennessee and developed a new TSD. The
TSD for this proposed action is included in the docket.\10\
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    \9\ EPA SO2 designations website can be found at
https://www.epa.gov/sulfur-dioxide-designations.
    \10\ The modeling files are not included in the electronic
docket for this proposed action due to their nature, size, and
incompatibility with the Federal Docket Management System. These
files are available at the EPA Region 4 office for review. To
request these files, please contact the person listed in the notice
under the section titled FOR FURTHER INFORMATION CONTACT.
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II. What are the criteria for redesignating an area from unclassifiable
to attainment/unclassifiable?

    Section 107(d)(3)(A) of the CAA provides that the Administrator may
notify the Governor of any state that the designation of an area should
be revised ``on the basis of air quality data, planning and control
considerations, or any other air quality-related considerations the
Administrator deems appropriate.'' \11\ The Act further provides in
section 107(d)(3)(D) that even if the Administrator has not notified a
state Governor that a designation should be revised, the Governor of
any state may, on the Governor's own motion, submit a request to revise
the designation of any area, and the Administrator must approve or deny
the request. In keeping with CAA section 107(d)(3)(A), areas that are
redesignated to attainment/unclassifiable \12\ must meet the
requirements for attainment areas and, thus, must meet the relevant
NAAQS. In addition, the area must not contribute to ambient air quality
in a nearby area that does not meet the NAAQS. See the definitions for
nonattainment area, attainment area, and unclassifiable area in CAA
section 107(d)(1)(A)(i)-(iii).
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    \11\ While CAA section 107(d)(3)(E) also lists specific
requirements for redesignations, those requirements only apply to
redesignations of nonattainment areas to attainment and, therefore,
are not applicable in the context of a redesignation of an area from
unclassifiable to attainment/unclassifiable.
    \12\ Historically, EPA has designated most areas that do not
meet the definition of nonattainment as ``unclassifiable/
attainment.'' EPA has reversed the order of the label to be
``attainment/unclassifiable'' to better convey the definition of the
designation category and so that the category is more easily
distinguished from the separate unclassifiable category. See 83 FR
1098 (January 9, 2018) and 83 FR 25776 (June 4, 2018). EPA reserves
the ``attainment'' category for when EPA redesignates a
nonattainment area that has attained the relevant NAAQS and has an
approved maintenance plan.
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    In its designations under the 2010 1-hour SO2 NAAQS, EPA
has generally defined an attainment/unclassifiable area as an area
that, based on available information including (but not limited to)
appropriate monitoring data and/or

modeling analyses, EPA has determined meets the NAAQS and determined
that the available information indicates that the area does not likely
contribute to ambient air quality in a nearby area that does not meet
the NAAQS. EPA is proposing to find that the Sumner County Area now
meets the definition of attainment/unclassifiable based upon air
quality dispersion modeling analyses that demonstrates attainment,
i.e., no violations of the 2010 1-hour SO2 NAAQS and not
contributing to a nearby area that is not meeting the NAAQS. EPA
preliminarily finds this information sufficient for the purposes of
redesignating an area from unclassifiable to attainment/unclassifiable.
Such redesignations are functionally similar to initial designations
and are not subject to CAA section 107(d)(3)(E), which, amongst other
things, requires attainment to be due to permanent and enforceable
measures and which requires a demonstration that the area will maintain
the NAAQS for 10 years.

III. What is EPA's rationale for proposing to redesignate the area?

    The Sumner County Area was designated unclassifiable by EPA on July
12, 2016. EPA's rationale for the unclassifiable designation is fully
explained in the TSD associated with that action.\13\ As discussed in
the final TSD, the revised modeling provided by Tennessee in March 2016
for the final designation action used allowable SO2
emissions rates from the TVA Gallatin facility that had not yet been
made federally enforceable. Additionally, the final modeling analysis
did not appropriately account for background SO2
concentrations in the Area which was considered inconsistent with EPA's
Modeling TAD and modeling guidelines in 40 CFR part 51, Appendix W.
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    \13\ The final Round 2 designations TSD can be found at https://www.epa.gov/sites/production/files/2016-07/documents/r4_tn_final_designation_tsd_06302016.pdf.
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    Tennessee submitted an updated modeling analysis with its letter
signed by Michelle Owenby, Director of TDEC's Division of Air Pollution
Control, on September 29, 2020, requesting that EPA redesignate Sumner
County, Tennessee, to attainment/unclassifiable for the 2010 1-hour
SO2 NAAQS.\14\ This updated modeling was performed using the
current version of EPA's recommended dispersion model, AERMOD version
19191, with the most recent three years of actual SO2
emissions (2017-2019) from the TVA Gallatin facility and concurrent
meteorology data. Additionally, the updated modeling used recent 2016
land cover data and appropriately accounted for background
SO2 concentrations in the Area. The TSD included in the
docket for this proposed redesignation action provides a detailed
summary of Tennessee's modeling analysis and EPA's evaluation of the
modeling.
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    \14\ The demonstration of attainment through air quality
dispersion modeling requires an area to review and report annual
SO2 emissions pursuant to DRR ongoing verification at 40
CFR 51.1205(b). In its September 29, 2020, redesignation request
letter, Tennessee also requested to terminate the section 51.1205(b)
annual reporting requirement because the modeling analyses
demonstrated a value of at least 50 percent below the 2010 1-hour
SO2 NAAQS at all receptors. EPA will address the annual
reporting termination request in a separate action which has no
bearing on the proposed approval of the redesignation.
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    According to EPA's guidance on redesignations, SO2
nonattainment areas using modeling to demonstrate attainment for a
redesignation request are expected to use maximum allowable
emissions.\15\ However, this statement derives from the requirements of
CAA section 107(d)(3)(E), which applies only to the redesignation of
nonattainment areas to attainment. For redesignations of unclassifiable
areas, the necessary analysis is equivalent to what would be required
in a designation in the first instance since EPA has not found the area
to be attainment or nonattainment. In this first instance, the goal is
to characterize existing ambient air quality. As such, it is
appropriate to use actual emissions for estimating existing air
quality. EPA's acceptance of modeling using actual emissions in this
instance should not be construed to define what would be needed for a
demonstration of attainment and maintenance for purposes of a
redesignation of a nonattainment area to attainment.
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    \15\ ``Guidance for 1-Hour SO2 Nonattainment Area SIP
Submissions,'' April 2014, at 67, available at https://www.epa.gov/sites/production/files/2016-06/documents/20140423guidance_nonattainment_sip.pdf; ``Use of Actual Emissions in
Maintenance Demonstrations for Ozone and Carbon Monoxide (CO)
Nonattainment Areas,'' November 1993, at 3, available at https://www3.epa.gov/ttn/naaqs/aqmguide/collection/cp2/19931130_berry_actual_emissions_ozone_co_maintenance_demos%20.pdf.
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    After reviewing Tennessee's request under CAA section 107(d)(3)(D)
and all available information, EPA is proposing to find that the
modeling provided by the State comports with EPA's current Modeling TAD
and EPA's Guideline on Air Quality Models (40 CFR part 51 Appendix W)
and is acceptable for assessing the attainment status of the Sumner
County Area. The State's modeling indicates that the predicted maximum
design value at any receptor in the modeling domain is 60.5 micrograms
per cubic meter ([micro]g/m\3\), or 23.1 ppb.\16\ EPA's review confirms
that the modeling results appropriately characterize the air quality in
the Sumner County Area that predicted ambient SO2
concentrations are below the 2010 1-hour SO2 NAAQS of 196.4
[micro]g/m\3\, or 75 ppb.\17\ Additionally, there is no evidence of
monitored or modeled violations in the surrounding counties such that
the source is contributing to any nearby area that does not meet the
NAAQS. EPA is therefore proposing to approve Tennessee's redesignation
request and proposing to redesignate the entirety of Sumner County that
was designated as unclassifiable in July 2016 to attainment/
unclassifiable based on the currently available information that
demonstrates attainment of the 2010 1-hour SO2 NAAQS.
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    \16\ The SO2 NAAQS and the design value compared to
the NAAQS is the 3-year average of the annual 99th percentile of 1-
hour daily maximum concentrations.
    \17\ See the TSD in the docket for this proposed action for
further information and analysis of the updated modeling.
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IV. Proposed Action

    EPA is proposing to approve Tennessee's September 29, 2020,
redesignation request and to redesignate the Sumner County Area from
unclassifiable to attainment/unclassifiable for the 2010 1-hour
SO2 NAAQS. EPA has reviewed the modeling provided by the
State with its redesignation request and preliminarily finds that it
complies with EPA's current Modeling TAD and EPA's Guideline on Air
Quality Models (40 CFR part 51 Appendix W) and is acceptable for
assessing the attainment status of the Sumner County Area. If
finalized, approval of the redesignation request would change the legal
designation, found at 40 CFR part 81, of Sumner County from
unclassifiable to attainment/unclassifiable for the 2010 1-hour
SO2 NAAQS.

V. Statutory and Executive Order Reviews

    Under the CAA, redesignation of an area to attainment/
unclassifiable is an action that affects the status of a geographical
area and does not impose any additional regulatory requirements on
sources beyond those imposed by state law. A redesignation to
attainment/unclassifiable does not create any new requirements.
Accordingly, this proposed action merely proposes to redesignate an
area to attainment/unclassifiable and does not impose additional
requirements. For that reason, this proposed action:

     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Will not have disproportionate human health or
environmental effects under Executive Order 12898 (59 FR 7629, February
16, 1994).
    This proposed action does not 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, this
proposed action does not have tribal implications as specified by
Executive Order 13175 (65 FR 67249, November 9, 2000), nor will it
impose substantial direct costs on tribal governments or preempt tribal
law.

List of Subjects in 40 CFR Part 81

    Environmental protection, Air pollution control.

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

    Dated: February 25, 2021.
John Blevins,
Acting Regional Administrator, Region 4.
[FR Doc. 2021-04406 Filed 3-4-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 80, Number 69 (Friday, April 10, 2015)]
[Notices]
[Page 19311]
[FR Doc No: 2015-08227]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER15-1400-000]

Erie Power, LLC; Supplemental Notice that Initial Market-Based
Rate Filing Includes Request for Blanket Section 204 Authorization

    This is a supplemental notice in the above-referenced proceeding,
of Erie Power, LLC's application for market-based rate authority, with
an accompanying rate schedule, noting that such application includes a
request for blanket authorization, under 18 CFR part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability is April 23, 2015.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
5 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426.
    The filings in the above-referenced proceeding(s) are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive email notification
when a document is added to a subscribed docket(s). For assistance with
any FERC Online service, please email<EMAIL_ADDRESS>or
call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

    Dated: April 3, 2015.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2015-08227 Filed 4-9-15; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 238 (Wednesday, December 15, 2021)]
[Rules and Regulations]
[Pages 71142-71144]
[FR Doc No: 2021-27132]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 876

[Docket No. FDA-2021-N-0583]

Medical Devices; Gastroenterology-Urology Devices; Classification
of the Nonimplanted Nerve Stimulator for Functional Abdominal Pain
Relief

AGENCY: Food and Drug Administration, HHS.

ACTION: Final amendment; final order.

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SUMMARY: The Food and Drug Administration (FDA or we) is classifying
the nonimplanted nerve stimulator for functional abdominal pain relief
into class II (special controls). The special controls that apply to
the device type are identified in this order and will be part of the
codified language for the nonimplanted nerve stimulator for functional
abdominal pain relief's classification. We are taking this action
because we have determined that classifying the device into class II
(special controls) will provide a reasonable assurance of safety and
effectiveness of the device. We believe this action will also enhance
patients' access to beneficial innovative devices.

DATES: This order is effective December 15, 2021. The classification
was applicable on June 7, 2019.

FOR FURTHER INFORMATION CONTACT: Pamela Scott, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4208, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

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

II. De Novo Classification

    On October 25, 2018, Innovative Health Solutions, Inc. submitted a
request for De Novo classification of the IB-Stim. FDA reviewed the
request in order to classify the device under the criteria for
classification set forth in section 513(a)(1) of the FD&C Act.
    We classify devices into class II if general controls by themselves
are insufficient to provide reasonable assurance of safety and
effectiveness, but there is sufficient information to establish special
controls that, in combination with the general controls, provide
reasonable assurance of the safety and effectiveness of the device for
its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the
information submitted in the request, we determined that the device can
be classified into class II with the establishment of special controls.
FDA

has determined that these special controls, in addition to the general
controls, will provide reasonable assurance of the safety and
effectiveness of the device.
    Therefore, on June 7, 2019, FDA issued an order to the requester
classifying the device into class II. In this final order, FDA is
codifying the classification of the device by adding 21 CFR
876.5340.\1\ We have named the generic type of device nonimplanted
nerve stimulator for functional abdominal pain relief, and it is
identified as a device that stimulates nerves remotely from the source
of pain with the intent to relieve functional abdominal pain. This
generic type of device does not include devices designed to relieve
pelvic pain.
---------------------------------------------------------------------------

    \1\ FDA notes that the ``ACTION'' caption for this final order
is styled as ``Final amendment; final order,'' rather than ``Final
order.'' Beginning in December 2019, this editorial change was made
to indicate that the document ``amends'' the Code of Federal
Regulations. The change was made in accordance with the Office of
Federal Register's (OFR) interpretations of the Federal Register Act
(44 U.S.C. chapter 15), its implementing regulations (1 CFR 5.9 and
parts 21 and 22), and the Document Drafting Handbook.
---------------------------------------------------------------------------

    FDA has identified the following risks to health associated
specifically with this type of device and the measures required to
mitigate these risks in table 1.

  Table 1--Nonimplanted Nerve Stimulator for Functional Abdominal Pain
                  Relief Risks and Mitigation Measures
------------------------------------------------------------------------
       Identified risks                   Mitigation measures
------------------------------------------------------------------------
Adverse tissue reaction......  Biocompatibility evaluation, and
                                Labeling.
Electrical, mechanical, or     Electromagnetic compatibility testing;
 thermal hazards leading to     Electrical, mechanical, and thermal
 user discomfort or injury.     safety testing; Non-clinical performance
                                testing; Software verification,
                                validation and hazard analysis; and
                                Labeling.
Infection....................  Sterility testing, Shelf life testing,
                                and Labeling.
------------------------------------------------------------------------

    FDA has determined that special controls, in combination with the
general controls, address these risks to health and provide reasonable
assurance of safety and effectiveness. In order for a device to fall
within this classification, and thus avoid automatic classification in
class III, it would have to comply with the special controls named in
this final order. The necessary special controls appear in the
regulation codified by this order. This device is subject to premarket
notification requirements under section 510(k).
    At the time of classification, nonimplanted nerve stimulators for
functional abdominal pain relief are for prescription use only.
Prescription devices are exempt from the requirement for adequate
directions for use for the layperson under section 502(f)(1) of the
FD&C Act (21 U.S.C. 352(f)(1)) and 21 CFR 801.5, as long as the
conditions of 21 CFR 801.109 are met.

III. Analysis of Environmental Impact

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

IV. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to
previously approved collections of information found in other FDA
regulations and guidance. These collections of information are subject
to review by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections
of information in the guidance document ``De Novo Classification
Process (Evaluation of Automatic Class III Designation)'' have been
approved under OMB control number 0910-0844; the collections of
information in 21 CFR part 814, subparts A through E, regarding
premarket approval, have been approved under OMB control number 0910-
0231; the collections of information in part 807, subpart E, regarding
premarket notification submissions, have been approved under OMB
control number 0910-0120; the collections of information in 21 CFR part
820, regarding quality system regulation, have been approved under OMB
control number 0910-0073; and the collections of information in 21 CFR
part 801, regarding labeling, have been approved under OMB control
number 0910-0485.

List of Subjects in 21 CFR Part 876

    Medical devices.

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

PART 876--GASTROENTEROLOGY-UROLOGY DEVICES

0
1. The authority citation for part 876 continues to read as follows:

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

0
2. Add Sec.  876.5340 to subpart F to read as follows:

Sec.  876.5340  Nonimplanted nerve stimulator for functional abdominal
pain relief.

    (a) Identification. A nonimplanted nerve stimulator for functional
abdominal pain relief is a device that stimulates nerves remotely from
the source of pain with the intent to relieve functional abdominal
pain. This generic type of device does not include devices designed to
relieve pelvic pain.
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) The patient-contacting components of the device must be
demonstrated to be biocompatible.
    (2) Electromagnetic compatibility and electrical, mechanical, and
thermal safety testing must be performed.
    (3) Electrical performance testing of the device and electrodes
must be conducted to validate the specified electrical output and
duration of stimulation of the device.
    (4) Software verification, validation, and hazard analysis must be
performed.
    (5) Sterility testing of the percutaneous components of the device
must be performed.
    (6) Shelf life testing must be performed to demonstrate continued
sterility, package integrity, and device functionality over the labeled
shelf life.
    (7) Labeling must include the following:
    (i) A detailed summary of the device technical parameters;
    (ii) A warning stating that the device is only for use on clean,
intact skin;

    (iii) Instructions for use, including placement of the device on
the patient; and
    (iv) A shelf life.

    Dated: December 9, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-27132 Filed 12-14-21; 8:45 am]
BILLING CODE 4164-01-P