[Federal Register Volume 85, Number 55 (Friday, March 20, 2020)]
[Notices]
[Page 16092]
[FR Doc No: 2020-05887]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

    Docket Number: PR20-44-000.
    Applicants: ONEOK Gas Transportation, L.L.C.
    Description: Tariff filing per 284.123(b)(1)+(g): Certification
Pursuant to 18 CFR Sec. 284.123(g)(9)(ii) to be effective 3/1/2020.
    Filed Date: 3/12/2020.
    Accession Number:<PHONE_NUMBER>00.
    Comments Due: 5 p.m. ET 4/2/2020.
    284.123(g) Protests Due: 5 p.m. ET 5/11/2020.

    Docket Numbers: RP20-656-000.
    Applicants: Trailblazer Pipeline Company LLC.
    Description: Penalty Revenues Refund Report of Trailblazer Pipeline
Company LLC under RP20-656.
    Filed Date: 3/12/20.
    Accession Number: 20200312-5173.
    Comments Due: 5 p.m. ET 3/24/20.

    Docket Numbers: RP20-657-000.
    Applicants: Crossroads Pipeline Company.
    Description: Pre-Arranged/Pre-Agreed (Settlement and Settlement
Agreement) Filing of Crossroads Pipeline Company under RP20-657.
    Filed Date: 3/12/20.
    Accession Number: 20200312-5174.
    Comments Due: 5 p.m. ET 3/24/20.

    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 date(s). 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: March 16, 2020.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2020-05887 Filed 3-19-20; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 110 (Thursday, June 10, 2021)]
[Proposed Rules]
[Pages 30854-30860]
[FR Doc No: 2021-12079]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R01-OAR-2021-0250; FRL-10024-67-Region 1]

Air Plan Approval; Maine and New Hampshire; 2015 Ozone NAAQS
Interstate Transport Requirements

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Clean Air Act (CAA) requires each State Implementation
Plan (SIP) to contain adequate provisions prohibiting emissions that
will have certain adverse air quality effects in other states. The
States of Maine and New Hampshire each made submissions to the
Environmental Protection Agency (EPA) to address these requirements for
the 2015 ozone National Ambient Air Quality Standards (NAAQS). EPA is
proposing to approve the submissions for each state as meeting the
requirement that each SIP contain adequate provisions to prohibit
emissions that will significantly contribute to nonattainment or
interfere with maintenance of the 2015 ozone NAAQS in any other state.

DATES: Written comments must be received on or before July 12, 2021.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R01-
OAR-2021-0250 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. Publicly
available docket materials are available at https://www.regulations.gov
or at the U.S. Environmental Protection Agency, EPA Region 1 Regional
Office, Air and Radiation Division, 5 Post Office Square--Suite 100,
Boston, MA. EPA requests that if at all possible, you contact the
contact listed in the FOR FURTHER INFORMATION CONTACT section to
schedule your inspection. The Regional Office's official hours of
business are Monday through Friday, 8:30 a.m. to 4:30 p.m., excluding
legal holidays and facility closures due to COVID-19.

FOR FURTHER INFORMATION CONTACT: Alison C. Simcox, Air Quality Branch,
U.S. Environmental Protection Agency, EPA Region 1, 5 Post Office
Square--Suite 100, (Mail code 05-2), Boston, MA 02109-3912, tel. (617)
918-1684, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    Throughout this document whenever ``we,'' ``us,'' or ``our'' is
used, we mean EPA.

Table of Contents

I. Background
II. Maine Submission
III. New Hampshire Submission
IV. EPA Evaluation of the States' Submittals
V. Proposed Action
VI. Statutory and Executive Order Reviews

I. Background

    On October 1, 2015, EPA promulgated a revision to the ozone NAAQS
(2015 ozone NAAQS), lowering the level of both the primary and
secondary standards to 0.070 parts per million (ppm).\1\ Section
110(a)(1) of the CAA requires states to submit, within 3 years after
promulgation of a new or revised standard, SIP submissions meeting the
applicable requirements of section 110(a)(2).\2\ One of these
applicable requirements is found in section 110(a)(2)(D)(i)(I),
otherwise known as the good neighbor provision, which generally
requires SIPs to contain adequate provisions to prohibit in-state
emissions activities from having certain adverse air quality effects on
other states due to interstate transport of pollution. There are four
so-called ``prongs'' within CAA section 110(a)(2)(D)(i); section
110(a)(2)(D)(i)(I) contains prongs 1 and 2. Under prongs 1 and 2 of the
good neighbor provision, a SIP for a new or revised NAAQS must contain
adequate provisions prohibiting any source or other type of emissions
activity within the state from emitting air pollutants in amounts that
will significantly contribute to nonattainment of the NAAQS in another
state (prong 1) or interfere with maintenance of the NAAQS in another
state (prong 2). EPA and states must give independent significance to
prong 1 and prong 2 when evaluating downwind air quality problems under
CAA section 110(a)(2)(D)(i)(I).\3\
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    \1\ National Ambient Air Quality Standards for Ozone, Final
Rule, 80 FR 65292 (October 26, 2015). Although the level of the
standard is specified in the units of ppm, ozone concentrations are
also described in parts per billion (ppb). For example, 0.070 ppm is
equivalent to 70 ppb.
    \2\ SIP revisions that are intended to meet the applicable
requirements of section 110(a)(1) and (2) of the CAA are often
referred to as infrastructure SIPs and the applicable elements under
section 110(a)(2) are referred to as infrastructure requirements.
    \3\ See North Carolina v. EPA, 531 F.3d 896, 909-911 (2008).
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    We note that EPA has addressed the interstate transport
requirements of CAA section 110(a)(2)(D)(i)(I) with respect to prior
ozone NAAQS in several regional regulatory actions, including the
Cross-State Air Pollution Rule (CSAPR), which addressed interstate
transport with respect to the 1997 ozone NAAQS as well as the 1997 and
2006 fine particulate matter standards,\4\ the Cross-State Air
Pollution Rule Update (CSAPR Update), and, most recently, the Revised
CSAPR Update for the 2008 ozone NAAQS.5 6
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    \4\ See 76 FR 48208 (August 8, 2011).
    \5\ Wisconsin v. EPA remanded the CSAPR Update to the extent it
failed to require upwind states to eliminate their significant
contribution by the next applicable attainment date by which
downwind states must come into compliance with the NAAQS, as
established under CAA section 181(a). Wisconsin v. EPA, 938 F.3d
303, 313 (D.C. Cir. 2019).
    \6\ The Revised Cross-State Air Pollution Rule Update for the
2008 Ozone NAAQs (86 FR 23054 (April 30, 2021)) was signed by the
EPA Administrator on March 15, 2021, and responded to the remand of
the CSAPR Update (81 FR 74504 October 26, 2016)) and the vacatur of
a separate rule, the CSAPR Close-Out (83 FR 65878 (December 21,
2018)) by the D.C. Circuit. Wisconsin v. EPA, 938 F.3d 303 (D.C.
Cir. 2019); New York v. EPA, 781 F. App'x. 4 (D.C. Cir. 2019).
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    Through the development and implementation of CSAPR and other
regional rulemakings pursuant to the good neighbor provision,\7\ EPA,
working in partnership with states, developed the following four-step
interstate transport framework to address the requirements of the good
neighbor provision for the ozone NAAQS: (1) Identify downwind air
quality problems; (2) identify upwind states that impact those downwind
air quality problems sufficiently such that they are considered
``linked'' and therefore warrant further review and analysis; (3)
identify the emissions reductions necessary (if any), considering air-
quality and cost factors, to prevent linked upwind states identified in
step 2 from contributing significantly to nonattainment or interfering
with maintenance of the NAAQS at the locations of the downwind air
quality problems; and (4) adopt permanent and enforceable measures
needed to achieve those emissions reductions.
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    \7\ In addition to the CSAPR rulemakings, other regional
rulemakings addressing ozone transport include the NOX
SIP Call, 63 FR 57356 (October 27, 1998), and the Clean Air
Interstate Rule (CAIR), 70 FR 25162 (May 12, 2005).
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    EPA has released several documents containing information relevant
to evaluating interstate transport with

respect to the 2015 ozone NAAQS. First, on January 6, 2017, EPA
published a notice of data availability (NODA) with preliminary
interstate ozone transport modeling with projected ozone design values
(DVs) for 2023 using a 2011 base year platform, on which we requested
public comment.\8\ In the NODA, EPA used the year 2023 as the analytic
year for this preliminary modeling because that year aligns with the
expected attainment year for Moderate ozone nonattainment areas for the
2015 ozone NAAQS.\9\ On October 27, 2017, we released a memorandum
(2017 memorandum) containing updated modeling data for 2023, which
incorporated changes made in response to comments on the NODA, and
noted that the modeling may be useful for states developing SIPs to
address good neighbor obligations for the 2008 ozone NAAQS.\10\ On
March 27, 2018, we issued a memorandum (March 2018 memorandum) noting
that the same 2023 modeling data released in the 2017 memorandum could
also be useful for identifying potential downwind air quality problems
with respect to the 2015 ozone NAAQS at step 1 of the four-step
interstate transport framework. The March 2018 memorandum also included
the then newly available contribution modeling results to assist states
in evaluating their impact on potential downwind air quality problems
for the 2015 ozone NAAQS under step 2 of the interstate transport
framework. EPA subsequently issued two more memoranda in August and
October 2018, providing additional information to states developing
good neighbor SIP submissions for the 2015 ozone NAAQS concerning,
respectively, potential contribution thresholds that may be appropriate
to apply in step 2 of the framework, and considerations for identifying
downwind areas that may have problems maintaining the standard at step
1 of the framework.\11\
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    \8\ See Notice of Availability of the Environmental Protection
Agency's Preliminary Interstate Ozone Transport Modeling Data for
the 2015 Ozone National Ambient Air Quality Standard (NAAQS), 82 FR
1733 (January 6, 2017).
    \9\ 82 FR 1733, 1735 (January 6, 2017).
    \10\ See Information on the Interstate Transport State
Implementation Plan Submissions for the 2008 Ozone National Ambient
Air Quality Standards under Clean Air Act Section
110(a)(2)(D)(i)(I), October 27, 2017, available in the docket for
this action or at https://www.epa.gov/interstate-air-pollution-transport/interstate-air-pollution-transport-memos-and-notices.
    \11\ See Analysis of Contribution Thresholds for Use in Clean
Air Act Section 110(a)(2)(D)(i)(I) Interstate Transport State
Implementation Plan Submissions for the 2015 Ozone National Ambient
Air Quality Standards, August 31, 2018) (``August 2018
memorandum''), and Considerations for Identifying Maintenance
Receptors for Use in Clean Air Act Section 110(a)(2)(D)(i)(I)
Interstate Transport State Implementation Plan Submissions for the
2015 Ozone National Ambient Air Quality Standards, October 19, 2018,
available in the docket for this action or at https://www.epa.gov/airmarkets/meme-and-supplemental-information-regarding-interstate-transport-sips-2015-ozone-naaqs.
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    On October 30, 2020, in the Notice of Proposed Rulemaking for the
Revised CSAPR Update, EPA released and accepted public comment on
updated 2023 modeling that used a 2016 emissions platform developed
under EPA/Multi-Jurisdictional Organization (MJO)/state collaborative
project as the primary source for the base year and future year
emissions data.\12\ On March 15, 2021, EPA signed the final Revised
CSAPR Update using the same modeling released at proposal.\13\ Although
Maine and New Hampshire relied on the modeling included in the March
2018 memo to develop their SIP submissions as EPA had suggested, EPA
now proposes to primarily rely on the updated and newly available 2016
base year modeling in evaluating these submissions. By using the
updated modeling results, EPA is using the most current and technically
appropriate information as the primary basis for this proposed
rulemaking. EPA's independent analysis, which also evaluated historical
monitoring data, recent DVs, and emissions trends, found that such
information provides additional support and further substantiates the
results of the 2016 base year modeling as the basis for this proposed
rulemaking. Section III of this notice and the Air Quality Modeling
technical support document (TSD) included in the docket for this
proposal contain additional detail on this modeling.\14\
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    \12\ See 85 FR 68964, 68981. The results of this modeling are
included in a spreadsheet in the docket for this action. The
underlying modeling files are available for public review in the
docket for the Revised CSAPR Update (EPA-HQ-OAR-2020-0272).
    \13\ See 86 FR 23054 at 23075, 23164 (April 30, 2021).
    \14\ See ``Air Quality Modeling Technical Support Document for
the Revised Cross-State Air Pollution Rule Update,'' 86 FR 23054
(April 30, 2021), available in the docket for this action. This TSD
was originally developed to support EPA's action in the Revised
CSAPR Update, as relating to outstanding good neighbor obligations
under the 2008 ozone NAAQS. While developed in this separate
context, the data and modeling outputs, including interpolated
design values for 2021, may be evaluated with respect to the 2015
ozone NAAQS and used in support of this proposal.
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    In the CSAPR, CSAPR Update, and the Revised CSAPR Update, EPA used
a threshold of one percent of the NAAQS to determine whether a given
upwind state was ``linked'' at step 2 of the interstate transport
framework and would, therefore, contribute to downwind nonattainment
and maintenance sites identified in step 1. If a state's impact did not
equal or exceed the one percent threshold, the upwind state was not
``linked'' to a downwind air quality problem, and EPA, therefore,
concluded the state would not significantly contribute to nonattainment
or interfere with maintenance of the NAAQS in the downwind states.
However, if a state's impact equaled or exceeded the one percent
threshold, the state's emissions were further evaluated in step 3,
considering both air quality and cost considerations, to determine
what, if any, emissions might be deemed ``significant'' and, thus, must
be eliminated under the good neighbor provision. EPA is proposing to
rely on the one percent threshold for the purpose of evaluating Maine
and New Hampshire's contributions to nonattainment or maintenance of
the 2015 ozone NAAQS in downwind areas.
    Several D.C. Circuit court decisions address the issue of the
relevant analytic year for the purposes of evaluating ozone transport
air-quality problems. On September 13, 2019, the D.C. Circuit issued a
decision in Wisconsin v. EPA, remanding the CSAPR Update to the extent
that it failed to require upwind states to eliminate their significant
contribution by the next applicable attainment date by which downwind
states must come into compliance with the NAAQS, as established under
CAA section 181(a). 938 F.3d 303, 313.
    On May 19, 2020, the D.C. Circuit issued a decision in Maryland v.
EPA that cited the Wisconsin decision in holding that EPA must assess
the impact of interstate transport on air quality at the next downwind
attainment date, including Marginal area attainment dates, in
evaluating the basis for EPA's denial of a petition under CAA section
126(b). Maryland v. EPA, 958 F.3d 1185, 1203-04 (D.C. Cir. 2020). The
court noted that ``section 126(b) incorporates the Good Neighbor
Provision,'' and, therefore, ``EPA must find a violation [of section
126] if an upwind source will significantly contribute to downwind
nonattainment at the next downwind attainment deadline. Therefore, the
agency must evaluate downwind air quality at that deadline, not at some
later date.'' Id. at 1204 (emphasis added). EPA interprets the court's
holding in Maryland as requiring the Agency, under the good neighbor
provision, to assess downwind air quality by the next applicable
attainment date, including a Marginal area attainment date under CAA
section

181 for ozone nonattainment.\15\ The Marginal area attainment date for
the 2015 ozone NAAQS is August 3, 2021.\16\ Historically, EPA has
considered the full ozone season prior to the attainment as supplying
an appropriate analytic year for assessing good neighbor obligations.
While this would be 2020 for an August 2021 attainment date (which
falls within the 2021 ozone season running from May 1 to September 30),
in this circumstance, when the 2020 ozone season is wholly in the past,
it is appropriate to focus on 2021 to address good neighbor obligations
to the extent possible by the 2021 attainment date. EPA does not
believe it would be appropriate to select an analytical year that is
wholly in the past, because the agency interprets the good neighbor
provision as forward looking. See 86 FR 23054 at 23074; see also
Wisconsin, 938 F.3d at 322. Consequently, in this proposal EPA will use
the analytical year of 2021 to evaluate Maine and New Hampshire's good
neighbor obligations with respect to the 2015 ozone NAAQS.
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    \15\ We note that the court in Maryland did not have occasion to
evaluate circumstances in which EPA may determine that an upwind
linkage to a downwind air quality problem exists at steps 1 and 2 of
the interstate transport framework by a particular attainment date,
but for reasons of impossibility or profound uncertainty the Agency
is unable to mandate upwind pollution controls by that date. See
Wisconsin, 938 F.3d at 320. The D.C. Circuit noted in Wisconsin that
upon a sufficient showing, these circumstances may warrant
flexibility in effectuating the purpose of the good neighbor
provision. Such circumstances are not at issue in the present
proposal.
    \16\ CAA section 181(a); 40 CFR 51.1303; Additional Air Quality
Designations for the 2015 Ozone National Ambient Air Quality
Standards, 83 FR 25776 (June 4, 2018, effective Aug. 3, 2018).
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II. Maine Submission

    On February 6, 2020, Maine submitted a SIP revision addressing the
CAA section 110(a)(2)(D)(i)(I) interstate transport requirements for
the 2015 ozone NAAQS.
    Maine relied on the results of EPA's modeling for the 2015 ozone
NAAQS contained in the March 2018 memorandum to identify downwind
nonattainment and maintenance receptors that may be impacted by
emissions from sources in Maine in the year 2023. These results
indicate Maine's greatest impact on any potential downwind
nonattainment or maintenance receptor would be 0.01 ppb in Suffolk
County, New York (monitoring site 361030002). Maine compared this value
to a screening threshold of 0.70 ppb, representing one percent of the
2015 ozone NAAQS. Because Maine's impacts to receptors in downwind
states are projected to be less than 0.70 ppb in 2023, Maine concluded
that emissions from sources within the state will not significantly
contribute to nonattainment or interfere with maintenance of the 2015
ozone NAAQS in any other state.

III. New Hampshire Submission

    On September 5, 2018, New Hampshire submitted a SIP revision
addressing the CAA section 110(a)(2)(D)(i)(I) interstate transport
requirements for the 2015 ozone NAAQS. This ``good neighbor SIP'' was
included as an enclosure in the state's infrastructure SIP for the same
NAAQS.
    New Hampshire relied on the results of EPA's modeling for the 2015
ozone NAAQS contained in the March 2018 memorandum to identify downwind
nonattainment and maintenance receptors that may be impacted by
emissions from sources in New Hampshire in the year 2023. These results
indicate New Hampshire's greatest impact on any potential downwind
nonattainment or maintenance receptor would be 0.06 ppb in Queens
County, New York (monitoring site 360810124). New Hampshire compared
this value to a screening threshold of 0.70 ppb, representing one
percent of the 2015 ozone NAAQS. Because New Hampshire's impacts to
receptors in downwind states are projected to be less than 0.70 ppb in
2023,\17\ New Hampshire concluded that emissions from sources within
the state will not significantly contribute to nonattainment or
interfere with maintenance of the 2015 ozone NAAQS in any other state.
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    \17\ New Hampshire incorrectly stated in its September 2018 good
neighbor SIP submission that the state's highest projected
contribution for 2023 to any downwind nonattainment or maintenance
receptor is 6 ppb; the modeled value should be 0.06 ppb as correctly
shown in Table 1 of the submission. New Hampshire also incorrectly
stated in their submission that 7 ppb, rather than 0.70 ppb, is 1%
of the NAAQS.
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    New Hampshire's September 2018 good neighbor SIP submission also
lists New Hampshire's regulations for controlling emissions of ozone
precursors as well as its regional emissions-control strategies. These
include Env-A 619, Prevention of Significant Deterioration (PSD), and
Env-A 618, Nonattainment New Source Review (NNSR) (82 FR 24057; May 25,
2017); and Env-A 2300, Mitigation of Regional Haze (77 FR 50602; August
22, 2012).

IV. EPA Evaluation of the States' Submittals

    Maine and New Hampshire's SIP submissions both rely on analysis of
the year 2023 to show that each state does not significantly contribute
to nonattainment or interfere with maintenance of the 2015 ozone NAAQS
in any other state. However, given the holdings in Wisconsin and
Maryland, analysis of that year is no longer sufficient where the next
attainment date for the 2015 ozone NAAQS is in 2021.\18\ Nonetheless,
the analysis EPA conducted for the 2021 analytical year corroborates
the conclusion reached in each state's submission.
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    \18\ We recognize that Maine, New Hampshire, and other states
may have been influenced by EPA's 2018 guidance memos (issued prior
to the Wisconsin and Maryland decisions) in making good neighbor
submissions that relied on EPA's modeling of 2023. When there are
intervening changes in relevant law or legal interpretation of CAA
requirements, states are generally free to withdraw, supplement,
and/or re-submit their SIP submissions with new analysis (in
compliance with CAA procedures for SIP submissions). While neither
Maine nor New Hampshire has done this, as explained in this section,
the independent analysis EPA has conducted at its discretion
confirms that the states' submissions in this instance are
ultimately approvable.
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    As stated in Section I of this notice, in consideration of the
holdings in Wisconsin and Maryland, EPA's analysis relies on 2021 as
the relevant attainment year for evaluating a State's good neighbor
obligations with respect to the 2015 ozone NAAQS using the four-step
interstate transport framework. In step 1, we identify locations where
the Agency expects there to be nonattainment or maintenance receptors
for the 2015 8-hour ozone NAAQS in the 2021 analytic future year. Where
EPA's analysis shows that an area or site does not fall under the
definition of a nonattainment or maintenance receptor in 2021, that
site is excluded from further analysis under EPA's four step interstate
transport framework.\19\ For areas that are identified as a
nonattainment or maintenance receptor in 2021, we proceed to the next
step of our four-step framework by identifying the upwind state's
contribution to those receptors.
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    \19\ While EPA has focused its analysis in this notice on the
year 2021, modeling data in the record for years 2023 and 2028
confirm that no new linkages to downwind receptors are projected for
these states in later years. This is not surprising as it is
consistent with an overall, long-term downward trend in emissions
from these states.
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    EPA's approach to identifying ozone nonattainment and maintenance
receptors in this action is consistent with the approach used in
previous transport rulemakings. EPA's approach gives independent
consideration to both the ``contribute significantly to nonattainment''
and the ``interfere with maintenance'' prongs of section
110(a)(2)(D)(i)(I), consistent with the

D.C. Circuit's direction in North Carolina.\20\
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    \20\ 531 F.3d at 910-911 (holding that EPA must give
``independent significance'' to each prong of CAA section
110(a)(2)(D)(i)(I)).
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    For the purpose of this proposal, EPA identifies nonattainment
receptors as those monitoring sites that are projected to have average
design values that exceed the NAAQS and that are also measuring
nonattainment based on the most recent monitored design values. This
approach is consistent with prior transport rulemakings, such as CSAPR
Update, where EPA defined nonattainment receptors as those areas that
both currently monitor nonattainment and that EPA projects will be in
nonattainment in the future analytic year.\21\
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    \21\ See 81 FR 74504 (October 26, 2016). Revised CSAPR Update
also used this approach. See 86 FR 23054 (April 30, 2021). This same
concept, relying on both current monitoring data and modeling to
define nonattainment receptor, was also applied in CAIR. See 70 FR
25241 (January 14, 2005). See also North Carolina, 531 F.3d at 913-
914 (affirming as reasonable EPA's approach to defining
nonattainment in CAIR).
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    In addition, in this proposal, EPA identifies a receptor to be a
``maintenance'' receptor for purposes of defining interference with
maintenance, consistent with the method used in the CSAPR and upheld by
the D.C. Circuit in EME Homer City Generation, L.P. v. EPA, 795 F.3d
118, 136 (D.C. Cir. 2015).\22\ Specifically, monitoring sites with a
projected maximum design value in 2021 that exceeds the NAAQS are
considered maintenance receptors. EPA's method of defining these
receptors takes into account both measured data and reasonable
projections based on modeling analysis.
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    \22\ See 76 FR 48208 (August 8, 2011). CSAPR Update and Revised
CSAPR Update also used this approach. See 81 FR 74504 (October 26,
2016) and See 86 FR 23054 (April 30, 2021).
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    Recognizing that nonattainment receptors are also, by definition,
maintenance receptors, EPA often uses the term ``maintenance-only'' to
refer to receptors that are not also nonattainment receptors.
Consistent with the methodology described above, monitoring sites with
a projected maximum design value that exceeds the NAAQS, but with a
projected average design value that is below the NAAQS, are identified
as maintenance-only receptors. In addition, those sites that are
currently measuring ozone concentrations below the level of the
applicable NAAQS, but are projected to be nonattainment based on the
average design value and that, by definition, are projected to have a
maximum design value above the standard are also identified as
maintenance-only receptors.
    To evaluate future air quality in steps 1 and 2 of the interstate
transport framework, EPA is using the 2016 and 2023 base case emissions
developed under EPA/MJO/state collaborative emissions modeling platform
project as the primary source for base year and 2023 future year
emissions data for this proposal.\23\ Because this platform does not
include emissions for 2021, EPA developed an interpolation technique
based on modeling for 2023 and measured ozone data to determine ozone
concentrations for 2021. To estimate average and maximum design values
for 2021, EPA first performed air quality modeling for 2016 and 2023 to
obtain design values in 2023. The 2023 design values were then coupled
with the corresponding 2016 measured design values to estimate design
values in 2021. Details on the modeling, including the interpolation
methodology, can be found in the Air Quality Modeling TSD, found in the
docket of this proposal.
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    \23\ See 86 FR 23054 (April 30, 2021). The results of this
modeling are included in a spreadsheet in the docket for this
action. The underlying modeling files are available for public
access in the docket for the Revised CSAPR Update (EPA-HQ-OAR-2020-
0272).
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    To quantify the contribution of emissions from specific upwind
states on 2021 8-hour design values for the identified downwind
nonattainment and maintenance receptors, EPA first performed
nationwide, state-level ozone source apportionment modeling for 2023.
The source apportionment modeling provided contributions to ozone from
precursor emissions of anthropogenic nitrogen oxides (NOX)
and volatile organic compounds (VOCs) in each state, individually. The
modeled contributions were then applied in a relative sense to the 2021
average design value to estimate the contributions in 2021 from each
state to each receptor. Details on the source apportionment modeling
and the methods for determining contributions in 2021 are in the Air
Quality Modeling TSD in the docket.
    The 2021 design values and contributions were examined to determine
if Maine and New Hampshire, considered separately, contribute at or
above the threshold of one percent of the 2015 ozone NAAQS (0.70 ppb)
to any downwind nonattainment or maintenance receptor. The data \24\
indicate that the highest contribution in 2021 from Maine to a downwind
nonattainment or maintenance receptor is 0.01 ppb to a maintenance
receptor in Fairfield County, Connecticut (monitoring site 90013007),
and, from New Hampshire, is 0.10 ppb to the same downwind receptor. The
data also show modeled ozone contributions from Maine and New Hampshire
to the design values of a larger set of monitoring sites (independent
of attainment status) and indicate that the highest projected
contribution in 2021 from Maine to any of these sites is 0.12 ppb to
monitors in Putnam and Westchester Counties in New York (monitoring
sites 360790005 and 361192004; #307 and #314 on the Design Values and
Contributions spreadsheet), and, from New Hampshire, is 1.46 ppb to the
monitor in Knox County, Maine (monitoring site 230130004; #226 on the
Design Values and Contributions spreadsheet). While New Hampshire's
modeled contribution to the Knox County monitor exceeds one percent of
the 2015 ozone NAAQS, EPA's analysis at step 1 does not identify the
Knox County monitor as a downwind area that may have problems
maintaining the 2015 ozone NAAQS. The Knox County monitor's projected
design value in 2021 is 57.4 ppb.
---------------------------------------------------------------------------

    \24\ The data are given in the ``Air Quality Modeling Technical
Support Document for the Revised Cross-State Air Pollution Rule
Update'' and ``Ozone Design Values and Contributions Revised CSAPR
Update.xlsx,'' which are included in the docket for this action.
---------------------------------------------------------------------------

    EPA also analyzed emissions trends for ozone precursors in Maine
and New Hampshire to support the findings from the air quality
analysis. In evaluating emissions trends, we first reviewed the
information submitted by each state and then reviewed additional
information available to the Agency. We focused on state-wide emissions
of nitrogen oxides and volatile organic compounds.25 26
Emissions from mobile sources, electric generating units (``EGUs''),
industrial facilities, gasoline vapors, and chemical solvents are some
of the major anthropogenic sources of ozone precursors. This evaluation
looks at both past emissions trends, as well as projected trends.
---------------------------------------------------------------------------

    \25\ This is because ground-level ozone is not emitted directly
into the air but is formed by chemical reactions between ozone
precursors, chiefly NOX and non-methane VOCs, in the
presence of sunlight.
    \26\ 81 FR 74504, 74513-14.
---------------------------------------------------------------------------

    As shown in Table 1, for Maine, between 2016 and 2023, annual total
NOX and VOC emissions are projected to decline by 38 percent
and 20 percent, respectively. For New Hampshire, between 2016 and 2023,
annual total NOX and VOC emissions are projected to decline
by 36 percent and 15 percent, respectively. The projected reductions
are a result of the implementation of existing control programs that
will continue to decrease NOX and VOC emissions in Maine and
New

Hampshire, as indicated by EPA's most recent 2021 and 2023 projected
emissions.
    As shown in Table 2, onroad and nonroad mobile source emissions
collectively comprise a large portion of each state's total
anthropogenic NOX and VOC. For example, in 2019,
NOX emissions from mobile sources in Maine comprised 52
percent of total NOX emissions and 48 percent of total VOC
emissions. In New Hampshire for that same year, NOX
emissions from mobile sources comprised 54 percent of total
NOX emissions and 45 percent of total VOC emissions.
    The large decrease in NOX emissions between 2016
emissions and projected 2023 emissions in each state is primarily
driven by reductions in emissions from onroad and nonroad mobile
sources. EPA projects that both VOC and NOX emissions will
continue declining out to 2023 as newer vehicles and engines that are
subject to the most recent, stringent mobile source standards replace
older vehicles and engines.\27\
---------------------------------------------------------------------------

    \27\ Tier 3 Motor Vehicle Emission and Fuel Standards (79 FR
23414, April 28, 2014); Mobile Source Air Toxics Rule (MSAT2) (72 FR
8428, February 26, 2007), Heavy-Duty Engine and Vehicle Standards
and Highway Diesel Fuel Sulfur Control Requirements (66 FR 5002,
January 18, 2001); Clean Air Nonroad Diesel Rule (69 FR 38957, June
29, 2004); Locomotive and Marine Rule (73 FR 25098, May 6, 2008);
Marine Spark-Ignition and Small Spark-Ignition Engine Rule (73 FR
59034, October 8, 2008); New Marine Compression-Ignition Engines at
or Above 30 Liters per Cylinder Rule (75 FR 22895, April 30, 2010);
and Aircraft and Aircraft Engine Emissions Standards (77 FR 36342,
June 18, 2012).
---------------------------------------------------------------------------

    In summary, there is no evidence to suggest that the overall
emissions trend demonstrated in Table 1 in either state will suddenly
reverse or spike in 2021 compared to historical emissions levels or
those projected for 2023. Further, there is no evidence that the
projected ozone precursor emissions trends out to 2023 and beyond would
not continue to show a decline in emissions. In addition, EPA's normal
practice is to include in our modeling only changes in NOX
or VOC emissions that result from final regulatory actions. Any
potential changes in NOX or VOC emissions that may result
from possible future or proposed regulatory actions are speculative.
    This downward trend in emissions in Maine and New Hampshire adds
support to the air quality analyses presented above for each state, and
indicates that the contributions from emissions from sources in Maine
and New Hampshire to ozone receptors in downwind states will continue
to decline and, for each state, remain below one percent of the NAAQS.
---------------------------------------------------------------------------

    \28\ The annual emissions data for the years 2011 through 2019
were obtained from EPA's National Emissions Inventory website:
https://www.epa.gov/air-emissions-inventories/air-pollutant-emissions-trends-data. Note that emissions from miscellaneous
sources are not included in the state totals. The emissions for 2021
and 2023 are based on the 2016 emissions modeling platform. See
``2005 thru 2019 + 2021_2023_2028 Annual State Tier1 Emissions'' and
the Emissions Modeling TSD in the docket for this action.

                                                 Table 1--Annual Emissions of NOX and VOC From Anthropogenic Sources in Maine and New Hampshire
                                                                                [Tons per year] \28\
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  2011       2012       2013       2014       2015       2016       2017       2018       2019    Projected 2021  Projected 2023
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
ME NOx.......................................................     59,773     57,292     54,812     52,332     51,871     49,148     49,889     48,440     46,542          33,996          30,536
ME VOC.......................................................     64,079     61,860     59,641     57,422     54,686     49,630     48,284     47,024     45,665          41,197          39,562
NH NOx.......................................................     36,554     37,065     37,577     38,086     35,025     30,775     28,530     27,408     25,680          21,822          19,579
NH VOC.......................................................     45,859     44,159     42,459     40,731     38,275     34,234     33,026     31,928     31,193          29,640          28,872
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

                                              Table 2--Annual Emissions of NOX and VOC From Onroad and Nonroad Vehicles in Maine and New Hampshire
                                                                                [Tons per year]
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  2011       2012       2013       2014       2015       2016       2017       2018       2019    Projected 2021  Projected 2023
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
ME...........................................................     41,601     38,861     36,122     33,382     31,465     27,286     26,570     25,714     24,005          17,841          16,214
NOx..........................................................
ME VOC.......................................................     40,376     38,091     35,805     33,519     30,884     25,929     24,683     23,423     22,064          18,037          16,499
NH NOx.......................................................     26,038     24,979     23,921     22,862     20,835     17,619     16,408     15,022     13,970          10,776           9,878
NH VOC.......................................................     25,314     24,184     23,054     21,924     20,027     16,544     15,895     14,796     14,062          11,947          11,277
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

    Thus, EPA's air quality and emissions analyses indicate that
emissions from Maine or from New Hampshire, with each state considered
individually, will not significantly contribute to nonattainment or
interfere with maintenance of the 2015 ozone NAAQS in any other state
in 2021.

V. Proposed Action

    As discussed in Sections II and III, Maine and New Hampshire have
each concluded that emissions from sources in their individual state
will not contribute to nonattainment or interfere with maintenance of
the 2015 ozone NAAQS in any other state. Each state submission reached
this conclusion by relying on information for the analytic year 2023.
As discussed above, the Wisconsin and Maryland decisions of the D.C.
Circuit have made clear that the good neighbor analysis for the 2015
ozone NAAQS must focus on the next attainment date, and that date is
the Marginal area attainment date in 2021. Therefore, EPA conducted
additional analysis to determine whether each state's conclusions would
remain valid in 2021 rather than 2023. EPA's evaluation of measured and
monitored data, including interpolating values to generate a reasonable
expectation of air quality and contribution values in 2021, as
discussed in Section IV, is consistent with conclusions made by Maine
and New Hampshire that, with each state considered separately,
emissions from sources in each state will not contribute to
nonattainment or interference with maintenance of the 2015 ozone NAAQS
in any other state. Because our analysis corroborates each state's
conclusion that emissions from within its state do not contribute to
nonattainment or interfere with maintenance of the 2015 ozone NAAQS in
another state, we propose to approve the Maine and New Hampshire
submissions as meeting CAA section 110(a)(2)(D)(i)(I).
    EPA is soliciting public comments on this notice. These comments
will be considered before taking final action. Interested parties may
participate in the

Federal rulemaking procedure by submitting written comments to this
proposed rule by following the instructions listed in the ADDRESSES
section of this Federal Register.

VI. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Act and
applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act.
Accordingly, this proposed action merely approves state law as meeting
Federal requirements and does not impose additional requirements beyond
those imposed by state law. For that reason, this 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 Clean Air Act; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where EPA or an Indian tribe has
demonstrated that a tribe has jurisdiction. In those areas of Indian
country, the rule does not have tribal implications and will not impose
substantial direct costs on tribal governments or preempt tribal law as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide,
Incorporation by reference, Intergovernmental relations, Lead, Nitrogen
dioxide, Ozone, Particulate matter, Reporting and recordkeeping
requirements, Sulfur oxides, Volatile organic compounds.

    Dated: June 3, 2021.
Deborah Szaro,
Acting Regional Administrator, EPA Region 1.
[FR Doc. 2021-12079 Filed 6-9-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 84, Number 44 (Wednesday, March 6, 2019)]
[Rules and Regulations]
[Pages 7993-7995]
[FR Doc No: 2019-04028]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 884

[Docket No. FDA-2019-N-0138]

Medical Devices; Obstetrical and Gynecological Devices;
Classification of the Software Application for Contraception

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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

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

DATES: This order is effective March 6, 2019. The classification was
applicable on August 10, 2018.

FOR FURTHER INFORMATION CONTACT: Paige Brown, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. G627, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the software application for
contraception as class II (special controls), which we have determined
will provide a reasonable assurance of safety and effectiveness. In
addition, we believe this action will enhance patients' access to
beneficial innovation, in part by reducing regulatory burdens by
placing the device into a lower device class than the automatic class
III assignment.
    The automatic assignment of class III occurs by operation of law
and without any action by FDA, regardless of the level of risk posed by
the new device. Any device that was not in commercial distribution
before May 28, 1976, is automatically classified as, and remains
within, class III and requires premarket approval unless and until FDA
takes an action to classify or reclassify the device (see 21 U.S.C.
360c(f)(1)). We refer to these devices as ``postamendments devices''
because they were not in commercial distribution prior to the date of
enactment of the Medical Device Amendments of 1976, which amended the
Federal Food, Drug, and Cosmetic Act (FD&C Act).
    FDA may take a variety of actions in appropriate circumstances to
classify or reclassify a device into class I or II. We may issue an
order finding a new device to be substantially equivalent under section
513(i) of the FD&C Act to a predicate device that does not require
premarket approval (see 21 U.S.C. 360c(i)). We determine whether a new
device is substantially equivalent to a predicate by means of the
procedures for premarket notification under section 510(k) of the FD&C
Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807).
    FDA may also classify a device through ``De Novo'' classification,
a common name for the process authorized under section 513(f)(2) of the
FD&C Act. Section 207 of the Food and Drug Administration Modernization
Act of 1997 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 shall
classify the device by written order within 120 days. The
classification will be according to the criteria under section
513(a)(1) of the FD&C Act. Although the device was automatically within
class III, the De Novo classification is considered to be the initial
classification of the device.
    We believe this De Novo classification will enhance patients'
access to beneficial innovation, in part by reducing regulatory
burdens. When FDA classifies a device into class I or II via the De
Novo process, the device can serve as a predicate for future devices of
that type, including for 510(k)s (see 21 U.S.C. 360c(f)(2)(B)(i)). As a
result, other device sponsors do not have to submit a De Novo request
or premarket approval application (PMA) in order to market a
substantially equivalent device (see 21 U.S.C. 360c(i), defining
``substantial equivalence''). Instead, sponsors can use the 510(k)
process, when necessary, to market their device.

II. De Novo Classification

    For this device, FDA issued an order on August 28, 2017, finding
Natural Cycles not substantially equivalent to a predicate not subject
to PMA. Thus, the device remained in class III in accordance with
section 513(f)(1) of the FD&C Act when we issued the order.
    On September 20, 2017, Natural Cycles Nordic AB submitted a request
for De Novo classification of Natural Cycles. 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 August 10, 2018, FDA issued an order to the requester
classifying the device into class II. FDA is codifying the
classification of the device by adding 21 CFR 884.5370. We have named
the generic type of device software application for contraception, and
it is identified as a device that provides user-specific fertility
information for preventing a pregnancy. This device includes an
algorithm that performs analysis of patient-specific data (e.g.,
temperature, menstrual cycle dates) to distinguish between fertile and
non-fertile days, then provides patient-specific recommendations
related to contraception.
    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--Software Application for Contraception Risks and Mitigation
                                Measures
------------------------------------------------------------------------
         Identified risks                    Mitigation measures
------------------------------------------------------------------------
Unintended pregnancy..............  Software verification, validation,
                                     and hazard analysis; clinical
                                     performance testing; human factors
                                     and usability 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) of the FD&C Act.

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. 3501-3520). The collections of information in the
guidance document ``De Novo Classification Process (Evaluation of
Automatic Class III Designation)'' have been approved under OMB control
number 0910-0844; the collections of information in part 820, regarding
design controls, have been approved under OMB control number 0910-0073;
the collections of information in 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; and the collections of information
in part 801, regarding labeling, have been approved under OMB control
number 0910-0485.

List of Subjects in 21 CFR Part 884

    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
884 is amended as follows:

PART 884--OBSTETRICAL AND GYNECOLOGICAL DEVICES

0
1. The authority citation for part 884 continues to read as follows:

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

0
2. Add Sec.  884.5370 to subpart F to read as follows:

Sec.  884.5370  Software application for contraception.

    (a) Identification. A software application for contraception is a
device that provides user-specific fertility information for preventing
a pregnancy. This device includes an algorithm that performs analysis
of patient-specific data (e.g., temperature, menstrual cycle dates) to
distinguish between fertile and non-fertile days, then provides
patient-specific recommendations related to contraception.
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) Clinical performance testing must demonstrate the contraceptive
effectiveness of the software in the intended use population.
    (2) Human factors performance evaluation must be provided to
demonstrate that the intended users can self-identify that they are in
the intended use population and can correctly use the application,
based solely on reading the directions for use for contraception.
    (3) Software verification, validation, and hazard analysis must be
performed. Documentation must include the following:
    (i) A cybersecurity vulnerability and management process to assure
software functionality; and
    (ii) A description of the technical parameters of the software,
including the algorithm used to determine fertility status and alerts
for user inputs outside of expected ranges.
    (4) Labeling must include:
    (i) The following warnings and precautions:
    (A) A statement that no contraceptive method is 100% effective.
    (B) A statement that another form of contraception (or abstinence)
must be used on days specified by the application.
    (C) Statements of any factors that may affect the accuracy of the
contraceptive information.
    (D) A warning that the application cannot protect against sexually
transmitted infections.
    (ii) Hardware platform and operating system requirements.
    (iii) Instructions identifying and explaining how to use the
software application, including required user inputs and how to
interpret the application outputs.
    (iv) A summary of the clinical validation study and results,
including effectiveness of the application as a stand-alone
contraceptive and how this effectiveness compares to other forms of
legally marketed contraceptives.

    Dated: February 28, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-04028 Filed 3-5-19; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 81, Number 6 (Monday, January 11, 2016)]
[Notices]
[Page 1281]
[FR Doc No: 2016-299]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Noise Exposure Map Notice; Westfield-Barnes Regional Airport;
Westfield, Massachusetts

AGENCY: Federal Aviation Administration, DOT.

ACTION: Notice.

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

SUMMARY: The Federal Aviation Administration (FAA) announces its
determination that the noise exposure maps for Westfield-Barnes
Regional Airport, as submitted by the City of Westfield, Massachusetts,
under the provisions of Title I of the Aviation Safety and Noise
Abatement Act of 1979 (Pub. L. 96-193) and 14 CFR part 150, are in
compliance with applicable requirements.

DATES: The effective date of the FAA's determination on the noise
exposure maps is December 22, 2015.

FOR FURTHER INFORMATION CONTACT: Richard Doucette, Federal Aviation
Administration, New England Region, Airports Division, 12 New England
Executive Park, Burlington, Massachusetts 01803.

SUPPLEMENTARY INFORMATION: This notice announces that the FAA finds
that the noise exposure maps submitted for Westfield-Barnes Regional
Airport are in compliance with applicable requirements of Part 150,
effective December 22, 2015.
    Under Section 103 of Title I of the Aviation Safety and Noise
Abatement Act of 1979 (hereinafter referred to as ``the Act''), an
airport operator may submit to the FAA noise exposure maps that meet
applicable regulations and that depict non-compatible land uses as of
the date of submission of such maps, a description of projected
aircraft operations, and the ways in which such operations will affect
such maps. The Act requires such maps to be developed in consultation
with interested and affected parties in the local community, government
agencies, and persons using the airport.
    An airport operator who has submitted such noise exposure maps that
are found by FAA to be in compliance with the requirements of Federal
Aviation Regulation (FAR) Part 150, promulgated pursuant to Title I of
the Act, may submit a noise compatibility program for FAA approval that
sets forth the measures the operator has taken, or proposes, for the
introduction of additional non-compatible uses.
    The FAA has completed its review of the noise exposure map and
related descriptions submitted by Westfield, Massachusetts. The
specific maps under consideration were ``Figure 3-9. DNL Contours for
Average Daily Aircraft Operations for CY2015'' and ``Figure 4-1. DNL
Contours for Average Daily Aircraft Operations for CY2020 NEM'' in the
submission. The FAA has determined that these maps for Westfield-Barnes
Regional Airport are in compliance with applicable requirements. This
determination is effective on December 22, 2015.
    FAA's determination on an airport operator's noise exposure maps is
limited to a finding that the maps were developed in accordance with
the procedures contained in Appendix A of FAR Part 150. Such
determination does not constitute approval of the applicant's data,
information or plans, or a commitment to approve a noise compatibility
program or to fund the implementation of that program.
    If questions arise concerning the precise relationship of specific
properties to noise exposure contours depicted on a noise exposure map
submitted under Section 103 of the Act, it should be noted that the FAA
is not involved in any way in determining the relative locations of
specific properties with regard to the depicted noise contours, or in
interpreting the noise exposure maps to resolve questions concerning,
for example, which properties should be covered by the provisions of
Section 107 of the Act. These functions are inseparable from the
ultimate land use control and planning responsibilities of local
government. These local responsibilities are not changed in any way
under Part 150 or through FAA's review of a noise exposure map.
Therefore, the responsibility for the detailed overlaying of noise
exposure contours onto the map depicting properties on the surface
rests exclusively with the airport operator that submitted the map or
with those public agencies and planning agencies with which
consultation is required under Section 103 of the Act. The FAA has
relied on the certification by the airport operator, under Section
150.21 of FAR Part 150, that the statutorily required consultation has
been accomplished.
    Copies of the noise exposure maps and of the FAA's evaluation of
the maps are available for examination at the following locations:

Westfield-Barnes Regional Airport, 110 Airport Drive, Westfield MA
01085.
Federal Aviation Administration, New England Region, Airports Division,
12 New England Executive Park, Burlington, Massachusetts 01803.

    Questions may be directed to the individual named above under the
heading: FOR FURTHER INFORMATION CONTACT.

    Issued in Burlington, Massachusetts on December 22, 2015.
Richard P. Doucette,
Environmental Program Manager, FAA New England Region, Airports
Division.
[FR Doc. 2016-299 Filed 1-8-16; 8:45 am]
 BILLING CODE 4910-13-P