[Federal Register Volume 85, Number 148 (Friday, July 31, 2020)]
[Notices]
[Page 46203]
[FR Doc No: 2020-16840]

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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meetings

TIME AND DATE:  2:00 p.m. on Wednesday, August 5, 2020.

PLACE:  The meeting will be held via remote means and/or at the
Commission's headquarters, 100 F Street NE, Washington, DC 20549.

STATUS:  This meeting will be closed to the public.

MATTERS TO BE CONSIDERED:  Commissioners, Counsel to the Commissioners,
the Secretary to the Commission, and recording secretaries will attend
the closed meeting. Certain staff members who have an interest in the
matters also may be present.
    In the event that the time, date, or location of this meeting
changes, an announcement of the change, along with the new time, date,
and/or place of the meeting will be posted on the Commission's website
at https://www.sec.gov.
    The General Counsel of the Commission, or his designee, has
certified that, in his opinion, one or more of the exemptions set forth
in 5 U.S.C. 552b(c)(3), (5), (6), (7), (8), 9(B) and (10) and 17 CFR
200.402(a)(3), (a)(5), (a)(6), (a)(7), (a)(8), (a)(9)(ii) and (a)(10),
permit consideration of the scheduled matters at the closed meeting.
    The subject matter of the closed meeting will consist of the
following topic:
    Institution and settlement of injunctive actions;
    Institution and settlement of administrative proceedings;
    Resolution of litigation claims; and
    Other matters relating to enforcement proceedings.
    At times, changes in Commission priorities require alterations in
the scheduling of meeting agenda items that may consist of
adjudicatory, examination, litigation, or regulatory matters.

CONTACT PERSON FOR MORE INFORMATION:  For further information; please
contact Vanessa A. Countryman from the Office of the Secretary at (202)
551-5400.

    Dated: July 29, 2020.
Vanessa A. Countryman,
Secretary.
[FR Doc. 2020-16840 Filed 7-29-20; 4:15 pm]
BILLING CODE 8011-01-P


Comment Info: =================

General Comment:Pharmacokinetics of methylphenidate of two modified-release formulations in healthy adults.


[Federal Register: July 18, 2006 (Volume 71, Number 137)]
[Notices]
[Page 40714]
[DOCID:fr18jy06-52]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP06-428-000]

Guardian Pipeline, L.L.C.; Notice of Tariff Filing

July 12, 2006.
    Take notice that on July 7, 2006, Guardian Pipeline, L.L.C.
(Guardian) tendered for filing, as part of its FERC Gas Tariff,
Original Volume No. 1 the following tariff sheets to become effective
August 6, 2006.

Fourth Revised Sheet No. 100
Second Revised Sheet No. 104
Original Sheet No. 220
Original Sheet No. 221
Sheet Nos. 222-229

    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed in accordance with the provisions of
section 154.210 of the Commission's regulations (18 CFR 154.210).
Anyone filing an intervention or protest must serve a copy of that
document on the Applicant. Anyone filing an intervention or protest on
or before the intervention or protest date need not serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is 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 e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
[FR Doc. E6-11357 Filed 7-17-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 84, Number 233 (Wednesday, December 4, 2019)]
[Proposed Rules]
[Pages 66363-66366]
[FR Doc No: 2019-26147]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R10-OAR-2019-0635, FRL-10002-87-Region 10]

Air Plan Approval; Washington; Revised Public Notice Provisions
and Other Miscellaneous Revisions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve revisions to the general air quality regulations submitted by
the Washington Department of Ecology. The four categories of revisions
to the State Implementation Plan (SIP) proposed for approval in this
action are: Revising the adoption by reference date for federal
regulations cross referenced in the state regulations; revising the
definition of volatile organic compounds (VOC) to match changes to the
federal definition; updating public involvement procedures for the new
source review air permitting program to reflect changes to the federal
requirements, allowing greater use of electronic notice and electronic
access to information; and correcting typographical errors and minor
wording changes for clarity.

DATES: Comments must be received on or before January 3, 2020.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R10-
OAR-2019-0635 at https://www.regulations.gov. Follow the online
instructions for submitting comments. Once submitted, comments cannot
be edited or removed from Regulations.gov. The EPA may publish any
comment received to its public docket. Do not submit electronically any
information you consider to be Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute.
Multimedia submissions (audio, video, etc.) must be accompanied by a
written comment. The written comment is considered the official comment
and should include discussion of all points you wish to make. The EPA
will generally not

consider comments or comment contents located outside of the primary
submission (i.e. on the web, cloud, or other file sharing system). For
additional submission methods, the full EPA public comment policy,
information about CBI or multimedia submissions, and general guidance
on making effective comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Jeff Hunt, EPA Region 10, 1200 Sixth
Avenue--Suite 155, Seattle, WA 98101, at<PHONE_NUMBER>, or
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we,''
``us,'' or ``our'' is used, it is intended to refer to the EPA. This
supplementary information section is arranged as follows:

Table of Contents

I. Background
II. Analysis of Rule Updates
III. Proposed Action
IV. Incorporation by Reference
V. Statutory and Executive Orders Review

I. Background

    Section 110 of the Clean Air Act (CAA) governs the process by which
a state submits air quality requirements to the EPA for approval into
the SIP. The SIP is a state's plan to implement, maintain, and enforce
the national ambient air quality standards (NAAQS). Washington's
general air quality regulations are set forth at Chapter 173-400 of the
Washington Administrative Code (WAC). On November 5, 2019, the
Washington Department of Ecology (Ecology) submitted a SIP revision
titled Revised Public Notice Provisions in Chapter 173-400 Washington
Administrative Code and Other Miscellaneous Changes. This SIP revision
includes changes to the public notice process as well as several
miscellaneous changes proposed for approval as described below. We note
that Ecology's SIP revision also included miscellaneous changes to the
statewide Chapter 173-405 WAC Kraft Pulping Mills, Chapter 173-410 WAC
Sulfite Pulping Mills, and Chapter 173-415 WAC Primary Aluminum Plants
regulations which we will address in a separate action.

II. Analysis of Rule Updates

A. WAC 173-400-025

    WAC 173-400-025 Adoption of Federal Rules, last approved by the EPA
on October 6, 2016, adopts by reference the federal air quality
regulations as they existed on January 1, 2016 (81 FR 69385). As part
of the current submittal, Ecology revised WAC 173-400-025 to include
changes to the federal air quality regulations as of January 24, 2018.
This includes, with certain exceptions, Ecology's adoption by reference
of 40 CFR 52.21, which implements the Prevention of Significant
Deterioration permitting program. The EPA is proposing to approve this
change.

B. Definition of VOC

    In several actions promulgated between 2012 and 2016, the EPA
revised the federal definition of VOC in 40 CFR 51.100(s) to add ten
compounds defined as VOC-exempt.\1\ In our February 25, 2016, final
rule (81 FR 9339), the EPA also eliminated recordkeeping, emissions
reporting, photochemical dispersion modeling and inventory requirements
related to t-butyl acetate (also known as tertiary butyl acetate or
TBAC; CAS Number: 540-88-5). As part of the current submittal, Ecology
revised the definition for ``Volatile organic compound (VOC)'' in WAC
173-400-030(102) to include all federal updates as of Ecology's rule
adoption.\2\ The EPA is proposing to approve this change.
---------------------------------------------------------------------------

    \1\ See 77 FR 37610 (June 22, 2012), 78 FR 9823 (February 12,
2013), 78 FR 53029 (August 28, 2013), 78 FR 62451 (October 22,
2013), 79 FR 17037 (March 27, 2014), 81 FR 9339 (February 25, 2016),
and 81 FR 50330 (August 1, 2016).
    \2\ On November 16, 2018, the EPA added HFO-1336mzz-Z to the
list of compounds excluded from the regulatory definition of
volatile organic compounds (83 FR 61127, November 28, 2018).
---------------------------------------------------------------------------

C. Permitting Public Involvement Requirements

    On October 18, 2016, the EPA revised the public involvement
requirements for federal, state, and local permitting programs,
including the new source review permitting program (81 FR 71613). The
EPA's final rule removed the mandatory requirement to provide public
notice of a draft air permit through publication in a newspaper.
Instead, the final rule allows for electronic notice (e-notice),
including electronic access to the draft permit (e-access), as an
option for permitting authorities implementing EPA-approved programs.
The EPA anticipated that e-notice would enable permitting authorities
to communicate permitting actions to the public more quickly and
efficiently. The EPA further anticipated that e-access would expand
access to permit-related documents. Ecology submitted revised versions
of WAC 173-400-171 Public Notice and Opportunity for Public Comment and
WAC 173-400-740 Permitting Public Involvement Requirements implementing
these changes. A redline/strikeout analysis of the changes is included
in the docket for this action. Ecology also added a definition in WAC
173-400-030(26) for the term ``electronic means'' to support the use of
e-notice and e-access. The EPA is proposing to approve the submitted
changes. We note that Ecology did not submit, and the EPA is not
proposing to approve, WAC 173-400-171 subsections (3)(o), (12), and the
portion of (3)(b) related to the regulation of toxic air pollutants,
because these subsections are outside the scope of this current action.

D. Typographical Corrections and Stylistic Changes

    As part of the Revised Public Notice Provisions in Chapter 173-400
Washington Administrative Code and Other Miscellaneous Changes
submittal, Ecology submitted several non-substantive typographical and
stylistic updates to WAC 173-400-030 Definitions, WAC 173-400-040
General Standards for Maximum Emissions, WAC 173-400-050 Emission
Standards for Combustion and Incineration Units, WAC 173-400-060
Emission Standards for General Process Units, and WAC 173-400-105
Records, Monitoring, and Reporting. A redline/strikeout of the changes
is included in the docket for this action. We note that Ecology did not
submit all changes to Chapter 173-400 WAC as part of this current
update. Specifically, Ecology submitted non-substantive revisions to
WAC 173-400-030 subsections: (5), (13), (18), (29), (30), (35), (48),
(53), (56), (59), (62), (72), (74), (82), (90), (91), (94), and (105).
We note that Ecology renumbered many of the definitions contained in
WAC 173-400-030 since our last approval (79 FR 59653, October 3, 2014).
As noted in the proposed rulemaking for our October 3, 2014, final
action, Ecology did not submit for approval the definition of `Toxic
air pollutant (TAP)' or `toxic air contaminant' contained in WAC 173-
400-030(91), because these pollutants are not criteria pollutants or
EPA-identified precursors under section 110 of the CAA.\3\ This
definition was subsequently renumbered to WAC 173-400-030(96) and was
again not submitted for approval. We also note that Washington did not
submit as part of this SIP revision several new definitions added to
WAC 173-400-030. Specifically, these definitions are WAC 173-400-030
subsections: (6), (45), (83), (89), (97), (100), (103) and (104).
Ecology also did not submit as part of this SIP revision, changes to
the definitions in

subsubsections (30) and (36), subsequently renumbered to (32) and (38).
Therefore, the EPA will retain the definitions last approved on October
3, 2014 (79 FR 59653). Similarly, Ecology submitted non-substantive
changes to WAC 173-400-040 subsection (1) but did not submit the more
substantive changes to subsection (2) as part of this update.\4\ The
EPA will retain the version of WAC 173-400-040(2) last approved on
October 6, 2016 (81 FR 69386). We also note that our prior approval of
WAC 173-400-040 did not include subsections (3) and (5), which were
also not submitted as part of this update. Other non-substantive
revisions submitted for approval include clarifying changes to WAC 173-
400-050 subsection (1), WAC 173-400-060, and WAC 173-400-105, which are
included in the docket for this action.
---------------------------------------------------------------------------

    \3\ 79 FR 39351, July 10, 2014, at page 39352.
    \4\ Ecology also revised WAC 173-400-040 subsection (7), however
the revised text was not part of the SIP.
---------------------------------------------------------------------------

E. Benton Clean Air Agency

    As discussed in our November 17, 2015 final approval, Benton Clean
Air Agency (BCAA) generally uses Chapter 173-400 WAC for program
implementation, with certain exceptions (80 FR 71695). Ecology
requested that the EPA approve the Chapter 173-400 WAC revisions
discussed above to apply within BCAA's jurisdiction, with one
exception. BCAA does not implement WAC provisions related to the
Prevention of Significant Deterioration permitting program under 173-
400-700 through 173-400-750. Therefore, Ecology did not request
approval of WAC 173-400-740 Permitting Public Involvement Requirements
for BCAA's direct permitting jurisdiction. We also note that in our
November 17, 2015, final approval, BCAA Regulation I, sections 4.01(A)
and 4.01(B) replaced the WAC 173-400-030 definitions for ``fugitive
dust'' and ``fugitive emissions.'' These two definitions were
renumbered in the most recent rule revision to WAC 173-400-030(40) and
(41), respectively. Similarly, in our prior approval, BCAA sections
4.02(B), 4.02(C)(1), and 4.02(C)(3) replaced WAC 173-400-040
subsections (4), (9)(a), and (9)(b), respectively. We are proposing to
revise our approval of the Benton Clean Air Agency regulations
accordingly.
    We are also proposing to correct a typographical error from a
previous approval. In our November 17, 2015 final approval, we approved
WAC 173-400-081 (state effective April 1, 2011) to apply in BCAA's
jurisdiction. In a subsequent final action published October 6, 2016
(81 FR 69389), our prior approval of WAC 173-400-081 was inadvertently
deleted from 40 CFR 52.2470(c), Table 4--Additional Regulations
Approved for Benton Clean Air Agency (BCAA) Jurisdiction. We are
proposing to amend 40 CFR 52.2470 to correct this error.

III. Proposed Action

    We are proposing to approve and incorporate by reference in the
Washington SIP at 40 CFR 52.2470(c) the following revisions as shown in
the table below. We are also proposing to correct 40 CFR 52.2470 for
BCAA's jurisdiction, as discussed above.

----------------------------------------------------------------------------------------------------------------
                                                                          State
            State citation                     Title/subject         effective date          Explanations
----------------------------------------------------------------------------------------------------------------
   40 CFR 52.2470(c), TABLE 2--ADDITIONAL REGULATIONS APPROVED FOR WASHINGTON DEPARTMENT OF ECOLOGY (ECOLOGY)
                                               DIRECT JURISDICTION
----------------------------------------------------------------------------------------------------------------
         Washington Administrative Code, Chapter 173-400--General Regulations for Air Pollution Sources
----------------------------------------------------------------------------------------------------------------
173-400-025..........................  Adoption of Federal Rules...         9/16/18  ...........................
173-400-030..........................  Definitions.................         9/16/18  Except: 173-400-030(6); 173-
                                                                                400-030(32); 173-400-
                                                                                030(38); 173-400-030(45);
                                                                                173-400-030(83); 173-400-
                                                                                030(89); 173-400-030(96);
                                                                                173-400-030(97); 173-400-
                                                                                030(100); 173-400-
                                                                                030(103); 173-400-
                                                                                030(104).
173-400-040..........................  General Standards for                9/16/18  Except: 173-400-040(2); 173-
                                        Maximum Emissions.                            400-040(3); 173-400-
                                                                                040(5).
173-400-050..........................  Emission Standards for               9/16/18  Except: 173-400-050(2); 173-
                                        Combustion and Incineration                   400-050(4); 173-400-
                                        Units.                                        050(5); 173-400-050(6).
173-400-060..........................  Emission Standards for              11/25/18  ...........................
                                        General Process Units.
173-400-105..........................  Records, Monitoring, and            11/25/18  ...........................
                                        Reporting.
173-400-171..........................  Public Notice and                    9/16/18  Except: The part of 173-400-
                                        Opportunity for Public                        171(3)(b) that says,
                                        Comment.                                       ``or any increase
                                                                                in emissions of a toxic
                                                                                air pollutant above the
                                                                                acceptable source impact
                                                                                level for that toxic air
                                                                                pollutant as regulated
                                                                                under chapter 173-460
                                                                                WAC''; 173-400-171(3)(o);
                                                                                173-400-171(12).
173-400-740..........................  PSD Permitting Public                9/16/18  ...........................
                                        Involvement Requirements.
----------------------------------------------------------------------------------------------------------------
   40 CFR 52.2470(c), TABLE 4--ADDITIONAL REGULATIONS APPROVED FOR BENTON CLEAN AIR AGENCY (BCAA) JURISDICTION
----------------------------------------------------------------------------------------------------------------
         Washington Administrative Code, Chapter 173-400--General Regulations for Air Pollution Sources
----------------------------------------------------------------------------------------------------------------
173-400-025..........................  Adoption of Federal Rules...         9/16/18  ...........................
173-400-030..........................  Definitions.................         9/16/18  Except: 173-400-030(6); 173-
                                                                                400-030(32); 173-400-
                                                                                030(38); 173-400-030(40);
                                                                                173-400-030(41); 173-400-
                                                                                030(45); 173-400-030(83);
                                                                                173-400-030(89); 173-400-
                                                                                030(96); 173-400-030(97);
                                                                                173-400-030(100); 173-400-
                                                                                030(103); 173-400-
                                                                                030(104).

173-400-040..........................  General Standards for                9/16/18  Except: 173-400-040(2); 173-
                                        Maximum Emissions.                            400-040(3); 173-400-
                                                                                040(4); 173-400-040(5);
                                                                                173-400-040(9).
173-400-050..........................  Emission Standards for               9/16/18  Except: 173-400-050(2); 173-
                                        Combustion and Incineration                   400-050(4); 173-400-
                                        Units.                                        050(5); 173-400-050(6).
173-400-060..........................  Emission Standards for              11/25/18  ...........................
                                        General Process Units.
173-400-105..........................  Records, Monitoring, and            11/25/18  ...........................
                                        Reporting.
173-400-171..........................  Public Notice and                    9/16/18  Except: The part of 173-400-
                                        Opportunity for Public                        171(3)(b) that says,
                                        Comment..                                      ``or any increase
                                                                                in emissions of a toxic
                                                                                air pollutant above the
                                                                                acceptable source impact
                                                                                level for that toxic air
                                                                                pollutant as regulated
                                                                                under chapter 173-460
                                                                                WAC''; 173-400-171(3)(o);
                                                                                173-400-171(12).
----------------------------------------------------------------------------------------------------------------

IV. Incorporation by Reference

    In this rule, the EPA is proposing to include in a final EPA rule
regulatory text that includes incorporation by reference. In accordance
with requirements of 1 CFR 51.5, the EPA is proposing to incorporate by
reference the regulations in section III above and correct the
typographical error discussed in section II.E. in this preamble. The
EPA has made, and will continue to make, these materials generally
available through www.regulations.gov.

V. Statutory and Executive Orders Review

    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, the 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);
     Is not an Executive Order 13771 (82 FR 9339, February 2,
2017) regulatory action because SIP approvals are exempted under
Executive Order 12866;
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because this action does not involve technical standards; and
     Does not provide the 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).
    The SIP is not approved to apply on any Indian reservation land in
Washington except as specifically noted below and is also not approved
to apply in any other area where the 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).
Washington's SIP is approved to apply on non-trust land within the
exterior boundaries of the Puyallup Indian Reservation, also known as
the 1873 Survey Area. Under the Puyallup Tribe of Indians Settlement
Act of 1989, 25 U.S.C. 1773, Congress explicitly provided state and
local agencies in Washington authority over activities on non-trust
lands within the 1873 Survey Area. Consistent with EPA policy, the EPA
provided a consultation opportunity to the Puyallup Tribe in a letter
dated March 21, 2018.

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.

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

    Dated: November 22, 2019.
Chris Hladick,
Regional Administrator, Region 10.
[FR Doc. 2019-26147 Filed 12-3-19; 8:45 am]
 BILLING CODE 6560-50-P


You Asked For the Following: Year : From: 1980 To: 2003 State : Middle Atlantic By State Species : SPOT " Year"," State"," Species"," Metric Tons"," Pounds","$" " 1980"," Delaware"," SPOT"," 2.4"," 5,300"," 2,5 30" " 1980"," New Jersey"," SPOT"," 1.1"," 2,400"," 528" " 1980"," New York"," SPOT"," 0.5"," 1,100"," 5 50" " 1981"," Delaware"," SPOT"," 5.0"," 11,100"," 2,7 75" " 1981"," New Jersey"," SPOT"," 2.7"," 6,000"," 2 ,611" " 1982"," Delaware"," SPOT"," 1.1"," 2,500"," 1,5 75" " 1982"," New Jersey"," SPOT"," 0.8"," 1,800"," 348" " 1983"," New Jersey"," SPOT"," 0.4"," 800"," 369" " 1984"," New Jersey"," SPOT"," 0.0"," 100"," 16" " 1985"," Delaware"," SPOT"," 7.8"," 17,200"," 5,1 60" " 1985"," New Jersey"," SPOT"," 1.1"," 2,400"," 452" " 1986"," Delaware"," SPOT"," 39.2"," 86,400"," 30,2 59" " 1986"," New Jersey"," SPOT"," 3.0"," 6,600"," 1 ,656" " 1987"," Delaware"," SPOT"," 63.5"," 140,100"," 36,3 09" " 1987"," New Jersey"," SPOT"," 7.2"," 15,900"," 4 ,084" " 1988"," Delaware"," SPOT"," 17.6"," 38,700"," 19,9 67" " 1988"," New Jersey"," SPOT"," 0.7"," 1,600"," 567" " 1989"," Delaware"," SPOT"," 13.2"," 29,000"," 12,8 29" " 1989"," New Jersey"," SPOT"," 3.7"," 8,200"," 3 ,645" " 1990"," Delaware"," SPOT"," 11.3"," 24,900"," 6,0 21" " 1990"," New Jersey"," SPOT"," 4.1"," 9,039"," 2 ,365" " 1991"," Delaware"," SPOT"," 107.1"," 236,200"," 75,5 04" " 1991"," New Jersey"," SPOT"," 24.7"," 54,433"," 18 ,196" " 1992"," Delaware"," SPOT"," 43.1"," 95,000"," 32,3 86" " 1992"," New Jersey"," SPOT"," 46.4"," 102,213"," 35 ,172" " 1993"," Delaware"," SPOT"," 10.0"," 22,000"," 5,5 00" " 1993"," New Jersey"," SPOT"," 4.9"," 10,900"," 2 ,502" " 1993"," New York"," SPOT"," 0.0"," 63"," 24" " 1994"," Delaware"," SPOT"," 45.5"," 100,400"," 56,0 06" " 1994"," New Jersey"," SPOT"," 14.2"," 31,408"," 16 ,468" " 1995"," Delaware"," SPOT"," 28.1"," 62,000"," 34,1 52" " 1995"," New Jersey"," SPOT"," 13.7"," 30,151"," 15 ,802" " 1995"," New York"," SPOT"," 0.0"," 22"," 15" " 1996"," New Jersey"," SPOT"," 0.5"," 1,149"," 526" " 1996"," New York"," SPOT"," 0.1"," 318"," 70" " 1997"," Delaware"," SPOT"," 16.2"," 35,686"," 19,4 66" " 1997"," New Jersey"," SPOT"," 2.8"," 6,175"," 3 ,592" " 1997"," New York"," SPOT"," 0.1"," 189"," 1 26" " 1998"," Delaware"," SPOT"," 63.7"," 140,363"," 59,7 15" " 1998"," New Jersey"," SPOT"," 12.5"," 27,582"," 11 ,312" " 1998"," New York"," SPOT"," 0.3"," 579"," 3 54" " 1999"," Delaware"," SPOT"," 23.4"," 51,534"," 24,0 09" " 1999"," New Jersey"," SPOT"," 3.5"," 7,822"," 3 ,712" " 2000"," Delaware"," SPOT"," 14.6"," 32,290"," 16,7 73" " 2000"," New Jersey"," SPOT"," 6.3"," 13,852"," 8 ,312" " 2000"," New York"," SPOT"," 0.4"," 939"," 2 17" " 2001"," Delaware"," SPOT"," 35.5"," 78,272"," 51,3 38" " 2001"," New Jersey"," SPOT"," 9.1"," 20,034"," 13 ,179" " 2001"," New York"," SPOT"," 0.1"," 160"," 37" " 2002"," Delaware"," SPOT"," 6.3"," 13,780"," 8,1 07" " 2002"," New Jersey"," SPOT"," 0.6"," 1,326"," 866" " 2002"," New York"," SPOT"," 2.6"," 5,737"," 1,5 02" " 2003"," Delaware"," SPOT"," 34.9"," 77,031"," 46,0 13" " 2003"," New Jersey"," SPOT"," 2.7"," 6,003"," 2 ,957" " 2003"," New York"," SPOT"," 0.0"," 35"," 13"


[Federal Register Volume 79, Number 183 (Monday, September 22, 2014)]
[Proposed Rules]
[Pages 56532-56538]
[FR Doc No: 2014-22453]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 890

[Docket No. FDA-2000-N-0158]

Reclassification of Iontophoresis Devices Intended for Any Other
Purposes

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed order.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to
reclassify iontophoresis devices intended for any other purposes, a
preamendments class III device, into class II (special controls), and
to amend the device identification. FDA is proposing this
reclassification on its own initiative based on new information. This
action implements certain statutory requirements.

DATES: Submit either electronic or written comments by December 22,
2014. See section XII for the proposed effective date of a final order
based on this proposed order.

ADDRESSES: You may submit comments by any of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     Mail/Hand delivery/Courier (for paper submissions):
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Docket No.
(FDA-2000-N-0158) for this rulemaking. All comments received may be
posted without change to http://www.regulations.gov, including any
personal information provided. For additional information on submitting
comments, see the ``Comments'' heading of the SUPPLEMENTARY INFORMATION
section of this document.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov and insert the
docket number, found in brackets in the heading of this document, into
the ``Search'' box and follow the prompts and/or go to the Division of
Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Michael Ryan, Center for Devices and
Radiological Health, Food and Drug Administration,10903 New Hampshire
Ave., Bldg. 66, Rm. 1615, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background--Regulatory Authorities

    The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended
by the Medical Device Amendments of 1976 (the 1976 amendments) (Pub. L.
94-295), the Safe Medical Devices Act of 1990 (Pub. L. 101-629), the
Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-
115), the Medical Device User Fee and Modernization Act of 2002 (Pub.
L. 107-250), the Medical Devices Technical Corrections Act (Pub. L.
108-214), the Food and Drug Administration Amendments Act of 2007 (Pub.
L. 110-85), and the Food and Drug Administration Safety and Innovation
Act (FDASIA) (Pub. L. 112-144), among other amendments, established a
comprehensive system for the regulation of medical devices intended for
human use. Section 513 of the FD&C Act (21 U.S.C. 360c) established
three categories (classes) of devices, reflecting the regulatory
controls needed to provide reasonable assurance of their safety and
effectiveness. The three categories of devices are class I (general
controls), class II (special controls), and class III (premarket
approval).
    Section 513(a)(1) of the FD&C Act defines class II devices as those
devices for which the general controls by themselves are insufficient
to provide reasonable assurance of safety and effectiveness, but for
which there is sufficient information to establish special controls to
provide such assurance.
    Under section 513 of the FD&C Act, devices that were in commercial
distribution before the enactment of the 1976 amendments, May 28, 1976
(generally referred to as preamendments devices), are classified after
FDA has: (1) Received a recommendation from a device classification
panel (an FDA advisory committee); (2) published the panel's
recommendation for comment, along with a proposed regulation
classifying the device; and (3) published a final regulation
classifying the device. FDA has classified most preamendments devices
under these procedures.
    Devices that were not in commercial distribution prior to May 28,
1976 (generally referred to as postamendments devices) are
automatically classified by section 513(f) of the FD&C Act into class
III without any FDA rulemaking process. Those devices remain in class
III and require premarket approval unless, and until, the device is
reclassified into class I or II or FDA issues an administrative order
finding the device to be substantially equivalent, in accordance with
section 513(i) of the FD&C Act, to a predicate device that does not
require premarket approval. The Agency determines whether new devices
are substantially equivalent to predicate devices by means of premarket
notification procedures in section 510(k) of the FD&C Act (21 U.S.C.
360(k)) and part 807 (21 CFR part 807).
    On July 9, 2012, FDASIA was enacted. Section 608(a) of FDASIA
amended section 513(e) of the FD&C Act, changing the process for
reclassifying a device from rulemaking to an administrative order.
Section 513(e) of the FD&C Act governs reclassification of classified
preamendments devices. This

section provides that FDA may, by administrative order, reclassify a
device based upon ``new information.'' FDA can initiate a
reclassification under section 513(e) of the FD&C Act or an interested
person may petition FDA to reclassify a preamendments device. The term
``new information,'' as used in section 513(e) of the FD&C Act,
includes information developed as a result of a reevaluation of the
data before the Agency when the device was originally classified, as
well as information not presented, not available, or not developed at
that time. (See, e.g., Holland Rantos v. United States Department of
Health, Education, and Welfare, 587 F.2d 1173, 1174 n.1 (D.C. Cir.
1978); Upjohn v. Finch, 422 F.2d 944 (6th Cir. 1970); Bell v. Goddard,
366 F.2d 177 (7th Cir. 1966).)
    Reevaluation of the data previously before the Agency is an
appropriate basis for subsequent regulatory action where the
reevaluation is made in light of newly available regulatory authority
(see Bell v. Goddard, supra, 366 F.2d at 181; Ethicon, Inc. v. FDA, 762
F.Supp. 382, 389-391 (D.D.C. 1991)) or in light of changes in ``medical
science'' (see Upjohn v. Finch, supra, 422 F.2d at 951). Whether data
before the Agency are past or new data, the ``new information'' to
support reclassification under section 513(e) must be ``valid
scientific evidence,'' as defined in 21 CFR 860.7(c)(2). (See, e.g.,
General Medical Co. v. FDA, 770 F.2d 214 (D.C. Cir. 1985); Contact Lens
Mfrs. Assoc. v. FDA, 766 F.2d 592 (D.C. Cir.), cert. denied, 474 U.S.
1062 (1986).)
    FDA relies upon ``valid scientific evidence'' in the classification
process to determine the level of regulation for devices. To be
considered in the reclassification process, the valid scientific
evidence upon which the Agency relies must be publicly available.
Publicly available information excludes trade secret and/or
confidential commercial information, e.g., the contents of a pending
premarket approval application (PMA). (See section 520(c) of the FD&C
Act (21 U.S.C. 360j(c)).)
    Section 513(e)(1) of the FD&C Act sets forth the process for
issuing a final reclassification order. Specifically, prior to the
issuance of a final order reclassifying a device, the following must
occur: (1) Publication of a proposed reclassification order in the
Federal Register; (2) a meeting of a device classification panel
described in section 513(b) of the FD&C Act; and (3) consideration of
comments to a public docket.
    In accordance with section 513(e)(1) of the FD&C Act, the Agency is
proposing, based on new information that has come to the Agency's
attention, to reclassify iontophoresis devices intended for any other
purposes because general controls and special controls are sufficient
to provide a reasonable assurance of safety and effectiveness.
Therefore, this order proposes to reclassify iontophoresis devices
intended for any other purposes into class II (special controls) and to
amend the device identification.
    Section 510(m) of the FD&C Act provides that a class II device may
be exempted from the premarket notification requirements under section
510(k) of the FD&C Act, if the Agency determines that premarket
notification is not necessary to assure the safety and effectiveness of
the device. FDA has determined that premarket notification is necessary
to assure the safety and effectiveness of iontophoresis devices
intended for any other purposes.

II. Regulatory History of the Device

    On August 28, 1979, FDA published a proposed rule for
classification of all iontophoresis devices in the Federal Register (44
FR 50520). This proposed classification was based on recommendations
made during three panel meetings in 1978, of the Physical Medicine
Panel; the Ear, Nose, and Throat Panel; and the Dental Products Panel.
The 1979 rule proposed that iontophoresis devices should have a split
classification; iontophoresis devices intended for diagnosis of cystic
fibrosis, anesthetizing the intact tympanic membrane, and dental
application of fluoride to the teeth would be class II, and
iontophoresis devices intended for any other purposes would be class
III. A second meeting of the Physical Medicine Panel in 1979 (the 1979
Panel) agreed with FDA's proposed rule, finding insufficient evidence
of safety and effectiveness of iontophoresis except in the uses
proposed for class II regulation. The 1979 Panel recommended that
iontophoresis devices for general drug delivery and hyperhidrosis be
classified in class III.
    The Agency agreed with the 1979 Panel that insufficient information
existed to determine that general controls would provide reasonable
assurance of the safety and effectiveness and that insufficient
information existed to establish a performance standard to provide this
assurance when the device was used for any purpose other than the three
uses proposed for class II regulation. However, FDA also regulates
drugs for safety and effectiveness and, at the time, the Agency was
unaware of any drug that had labeling providing adequate directions for
its use with an iontophoresis device for the dental application of
fluoride or the anesthetizing of the intact tympanic membrane.
Therefore, in order to prevent conflicting regulatory requirements
between the Center for Devices and Radiological Health (CDRH) and the
Center for Drug Evaluation and Research (CDER), CDRH determined that
iontophoresis devices for the dental application of fluoride or the
anesthetizing of the intact tympanic membrane should be classified into
class III.
    On November 23, 1983, FDA published a final rule in the Federal
Register classifying iontophoresis devices with a split classification
(48 FR 53032 at 53045). The final rule revised the information that had
been presented in the proposed rule to omit the dental application of
fluoride and anesthetizing the intact tympanic membrane from the class
II uses. The rule classified iontophoresis devices into class II when
intended to induce sweating for use in the diagnosis of cystic fibrosis
or for other uses if the labeling of the drug intended for use with the
device bears adequate directions for the device's use with that drug
(Sec.  890.5525(a) (21 CFR 890.5525(a)). The rule classified
iontophoresis devices into class III when intended for any other
purposes (Sec.  890.5525(b)), but did not establish an effective date
of requirement for premarket approval.
    On August 22, 2000, FDA published a proposed rule in the Federal
Register (65 FR 50949) (the August 2000 proposed rule) to amend the
iontophoresis regulation to remove paragraph (b), the class III
identification, such that only paragraph (a) of the regulation, the
class II identification, would remain. In this rule, FDA stated that it
believed it had made an error in the original classification and that
there were no iontophoresis devices on the market prior to the Medical
Device Amendments of 1976 (preamendments devices) that met the class
III identification. Although several devices had been cleared under
this regulation between 1976 and the publication of the proposed rule,
FDA believed that those devices could meet the definition of a class II
iontophoresis device with modifications to their labeling. Any device
that could not meet the class II definition (i.e., for any other use
than the diagnosis of cystic fibrosis or with a specific drug approved
for iontophoretic delivery) would require submission of a PMA.
    FDA received seven comments in response to the August 2000 proposed

rule (see Docket No. FDA-2000-N-0158). Several comments disagreed with
FDA's assertion that no class III preamendments iontophoresis devices
existed. Two comments asserted that the assumption that there are
differences between different iontophoresis devices that would warrant
linking a particular device to a particular drug is in error, and
suggested that FDA should consider reclassification of iontophoresis
devices into either class I or class II as drug delivery systems
comparable to syringes and pumps. In contrast, another comment rejected
what it perceived as the implication that all iontophoresis drug
delivery systems were the same and that any iontophoresis device could
be relabeled to reference any drug approved for iontophoretic
administration, whether or not the drug had actually been tested for
use with that particular device.
    As a result of these comments, FDA withdrew the August 2000
proposed rule on November 4, 2004 (69 FR 64266). In the same issue of
the Federal Register, FDA also published a notice of its intent to
initiate a proceeding to reclassify class III iontophoresis devices
intended for any other purposes into class II (special controls) (69 FR
64313).
    In 2009, FDA published an order in the Federal Register under
section 515(i) of the FD&C Act (21 U.S.C. 360e(i)) to call for
information on the remaining class III 510(k) devices (74 FR 16214,
April 9, 2009). FDA received 10 submissions regarding iontophoresis
devices in response to that order (see Docket No. FDA-2009-M-0101). One
response stated that the company was only a repackager/relabeler of the
device and did not have a recommended classification or information on
safety and effectiveness. The remaining nine responses were all from
manufactures of iontophoresis devices. Eight of the manufacturers
recommended that the devices be reclassified into class II with special
controls. The other manufacturer provided only safety and effectiveness
information and did not recommend a classification. The risks to health
identified by the manufacturers are included as part of the discussion
in section V.
    On February 21, 2014, FDA held a classification panel meeting of
the Orthopaedic and Rehabilitation Devices Panel (the 2014 Panel) in
accordance with section 513(b) of the FD&C Act to discuss the
reclassification of iontophoresis devices intended for any other
purposes (Ref. 1). This device classification panel meeting discussed
the relevant data and information described in this order, the risks to
health for iontophoresis devices intended for any other purposes,
whether they should be reclassified or remain in class III, and
possible special controls for these devices if reclassified into class
II. The Panel believed that iontophoresis devices intended for any
other purposes present a potential unreasonable risk of illness or
injury and recommended that general controls alone are not sufficient
to ensure the safety and effectiveness of these devices. In
deliberating whether sufficient information exists to establish special
controls for these devices, the Panel voiced significant concerns over
possible systemic effects that might be produced by some drugs,
particularly fentanyl, or by misuse of drugs. The Panel consensus was
that if this issue could be addressed, sufficient information exists to
establish special controls for these devices that would mitigate the
risks to health identified by FDA and the Panel, and that special
controls, in combination with general controls, could provide a
reasonable assurance of safety and effectiveness and these devices
could be classified in class II.
    In order to address the Panel's concerns regarding systemic effects
of the delivered drug, FDA is proposing to amend the identification of
iontophoresis devices intended for any other purposes to clarify that
devices intended to deliver specific drugs that may have adverse
systemic effects, like fentanyl, are not considered part of this
regulatory classification, and that only iontophoresis devices not
labeled for use with a specific drug, or labeled for use with a non-
drug solution, are included. An iontophoresis device intended to
deliver a specific drug with systemic effects, such as fentanyl, would
be regulated as a combination product in CDER under section 503(g) of
the FD&C Act (21 U.S.C. 353(g)) and Sec.  3.2(e) (21 CFR 3.2(e)) or
under Sec.  890.5525(a)) (the iontophoresis regulation). FDA believes
this will also help clarify the difference between the two regulatory
subsets of iontophoresis devices. In addition, FDA is proposing a
special control that will require iontophoresis device manufacturers to
include labeling warnings regarding adverse systemic effects.

III. Device Description

    Iontophoresis is a noninvasive transdermal delivery method in which
a substance bearing a charge is propelled through the skin by an
electric current. Iontophoresis devices generally consist of a
controller, active and return electrode(s), and a power supply used to
deliver currents to transport drugs, soluble salts, ionic solutions, or
other drugs into the body for medical purposes as an alternative to
hypodermic injections. Iontophoresis systems consist of the
iontophoresis device and the drug or other solution to be administered.
If the system is marketed as a complete product that includes both a
device and drug component, then it would be regulated as a drug-device
combination product (see Sec.  3.2(e)), and CDER would have the lead
jurisdictional authority because the primary mode of action of the
combination product is attributable to the drug component (see Sec.
3.2(m) and 21 CFR 3.4(a)). Alternatively, if the device component is
marketed separately from a drug, or as a complete system with a non-
drug solution, then it would be regulated as a medical device by CDRH.
    The iontophoresis classification regulation is split into two
parts, as described previously. Iontophoresis devices intended for use
in the diagnosis of cystic fibrosis or for use with a specific drug
that has been approved for delivery by iontophoresis are class II
devices regulated under Sec.  890.5525(a). These devices are not the
subject of this proposed order. Iontophoresis devices intended for any
other purposes are currently class III devices regulated under Sec.
890.5525(b). ``Any other purposes'' means that these devices are not
intended for use in the diagnosis of cystic fibrosis and not indicated
for use with a specific drug; that is, these devices are intended for
general iontophoretic delivery of drugs that are approved for that
route of administration. This device subset also includes devices
indicated for use with specific non-drug solutions, such as tap water
(e.g., for treatment of hyperhidrosis). FDA is proposing in this order
to reclassify iontophoresis devices intended for any other purposes
from class III to class II. FDA is also proposing in this order to
amend the device identification in order to clarify the difference
between the two subsets of iontophoresis devices in Sec.  890.5525, to
emphasize that iontophoresis devices intended and labeled for use with
specific drugs are regulated under Sec.  890.5525(a), and to clarify
that these are prescription devices in accordance with Sec.  801.109
(21 CFR 801.109).

IV. Proposed Reclassification

    FDA is proposing that iontophoresis devices intended for any other
purposes be reclassified from class III to class II (special controls).
FDA is also proposing, in response to the concerns voiced by the 2014
Orthopaedic and Rehabilitation Devices Classification Panel regarding
adverse systemic effects of drug delivery via iontophoresis

devices, to amend the identification of these devices to clarify that
iontophoresis devices intended for any other purposes do not include
devices labeled for use with specific drugs. In this proposed order,
the Agency has identified special controls under section 513(a)(1)(B)
of the FD&C Act that, if finalized, together with general controls
(including prescription use restrictions) applicable to the devices,
would provide reasonable assurance of their safety and effectiveness.
Absent the special controls identified in this proposed order, general
controls applicable to the device are insufficient to provide
reasonable assurance of the safety and effectiveness of the device. FDA
believes that iontophoresis devices may benefit patients by improving
the noninvasive transdermal delivery of drugs or other solutions
intended to treat various medical ailments or issues.
    Therefore, in accordance with sections 513(e) and 515(i) of the
FD&C Act and Sec.  860.130 (21 CFR 860.130), based on new information
with respect to the devices and taking into account the public health
benefit of the use of the device and the nature and known incidence of
the risks of the device, FDA, on its own initiative, is proposing to
reclassify this preamendments class III device into class II. FDA
believes that this new information is sufficient to demonstrate that
the proposed special controls can effectively mitigate the risks to
health identified in section V, and that these special controls,
together with general controls (including prescription use
restrictions), will provide a reasonable assurance of safety and
effectiveness for iontophoresis devices intended for any other
purposes.
    Section 510(m) of the FD&C Act authorizes the Agency to exempt
class II devices from premarket notification (510(k)) requirements. FDA
has considered iontophoresis devices intended for any other purposes
and has determined that the device does require premarket notification
(510(k)). Therefore, the Agency does not intend to exempt this proposed
class II device from premarket notification (510(k)) submission
requirements as provided for under section 510(m) of the FD&C Act.

V. Risks to Health

    After considering available information, including a comprehensive
review of relevant literature and the recommendations of the 2014
Orthopaedic and Rehabilitation Devices Classification Panel (Ref. 1),
FDA has determined that the following risks to health are associated
with the use of iontophoresis devices intended for any other purposes.
     Electric shock: Electrical shock hazards may pose a hazard
to both operators and users. Excessive leakage current from the device
could result in injury, or a malfunction of the device could result in
electrical shock. Possible adverse events include cardiac events such
as arrhythmias and cardiac arrest.
     Burns: Patient or user burns could result from a large
electrical current density or a highly acidic solution.
     Insufficient or excessive delivery of drug or solution:
Device malfunction (such as inaccurate current measurement), use error,
or inadequate information on the drug or solution being used may result
in inappropriate drug or solution delivery.
     Interference with other medical devices: Electromagnetic
interference could interfere with other devices in the treatment
environment, such as pacemakers implanted in either the patient or
user.
     Adverse tissue reactions: Device materials that are not
biocompatible may either directly or through the release of their
material constituents or through a reaction with the ionic solution:
(1) Produce adverse local or systemic effects such as contact
dermatitis and scarring, (2) be carcinogenic, or (3) produce adverse
reproductive and developmental effects. Although medical devices may
have myriad biocompatibility issues, the biocompatibility concerns from
iontophoresis devices are likely limited to skin reactions.
     Infection: Infection can occur from use of a non-sterile
iontophoresis device, or from improper device design or use error. This
risk is particularly relevant for devices used in the ear.
     Ear Trauma (when used in the ear): Use error or improper
device design can lead to ear trauma, when used in the ear. This
includes perforation of the tympanic membrane and middle or inner ear
injuries.

VI. Summary of Reasons for Reclassification

    Based on the comments from the 2014 Panel meeting and FDA's
assessment of new, valid scientific data related to the health benefits
and risks associated with iontophoresis devices intended for any other
purposes, FDA is proposing that these devices should be reclassified
from class III to class II because sufficient information exists to
establish specials controls, which, in addition to general controls,
would provide a reasonable assurance of safety and effectiveness of the
device, and because general controls themselves are insufficient to
provide a reasonable assurance of its safety and effectiveness.
    FDA does not believe that iontophoresis devices not intended for
use with a specific drug or solution are life-supporting or life-
sustaining, or for a use which is of substantial importance in
preventing impairment of human health. FDA does believe these devices
may present a potential unreasonable risk of illness or injury, as a
review of the relevant clinical literature indicates. However, FDA
believes that special controls, in combination with general controls,
would provide reasonable assurance of safety and effectiveness.

VII. Summary of Data Upon Which the Reclassification Is Based

    FDA believes that the identified special controls, in addition to
general controls (including prescription use restrictions), are
necessary to provide reasonable assurance of safety and effectiveness
of these devices. Therefore, in accordance with sections 513(e) and
515(i) of the FD&C Act and Sec.  860.130, based on new information with
respect to the device and taking into account the public health
benefit(s) of the use of the device and the nature and known incidence
of the risk(s) of the device, FDA, on its own initiative, is proposing
to reclassify this preamendments class III device into class II. The
Agency has identified special controls that would provide reasonable
assurance of their safety and effectiveness. FDA's review of the
clinical literature has been previously summarized in the Executive
Summary to the 2014 Panel meeting to discuss iontophoresis device
classification (Ref. 1).
    In addition, the 2014 Panel reviewed and discussed recent
information presented by FDA, a manufacturer of iontophoresis devices,
and members of the public. This information included recent literature
regarding the possible risks to health and a review of FDA's
Manufacturer and User Facility Device Experience (MAUDE) database.
    The 2014 Panel agreed that iontophoresis devices not intended for
use with specific drugs or solutions are not ``life-supporting or life-
sustaining, or of substantial importance in preventing impairment of
human health.'' The 2014 Panel agreed on the potential risks to health
identified by FDA with some proposed clarifications, which were
incorporated in section V. However, the 2014 Panel also expressed
concerns regarding adverse systemic effects that might potentially
result from use of iontophoresis devices to deliver drugs such as
fentanyl, repeated treatments with certain drugs, or

misuse. In order to address the Panel's concerns regarding systemic
effects, FDA is proposing to amend the identification of iontophoresis
devices intended for any other purposes to clarify that devices
intended to deliver specific drugs that may have adverse systemic
effects, like fentanyl, are not considered part of this regulatory
classification. An iontophoresis device intended to deliver a specific
drug with systemic effects, such as fentanyl, would be regulated as a
combination product in CDER or under Sec.  890.5525(a). FDA believes
this will help clarify the difference between the two regulatory
subsets of iontophoresis devices. In addition, FDA is proposing a
special control that will require iontophoresis device manufacturers to
include labeling warnings regarding adverse systemic effects. Regarding
the benefits of iontophoresis devices not intended for use with a
specific drug or solution, the 2014 Panel indicated that they believe
that the benefit provided by these devices outweigh the probable risks,
as long as their concern about potential adverse systemic events could
be addressed.
    Regarding classification, there was general panel consensus that
iontophoresis devices not intended for use with a specific drug or
solution should be class II devices subject to special controls, unless
the devices were used to deliver a treatment with potential adverse
systemic effects. The Panel believed that such devices should be class
III. However, iontophoresis devices intended to deliver specific drugs
are not included in this regulatory subset of iontophoresis devices,
and are regulated separately under Sec.  890.5525(a) or as combination
products in CDER. FDA believes that its proposal to amend the
identification of iontophoresis devices regulated under Sec.
890.5525(b), as well as its proposed special controls, will address the
Panel's concern. There was general consensus among the Panel that if
that concern could be addressed that the special controls identified by
FDA were appropriate. The Panel agreed that general controls alone are
not sufficient to provide reasonable assurance of the safety and
effectiveness of these devices.

VIII. Proposed Special Controls

    FDA believes that the following special controls, in addition to
general controls (including applicable prescription use restrictions),
are sufficient to mitigate the risks to health described in section V:
    1. Performance testing must provide a reasonable assurance of
safety and effectiveness of the device, including:
    a. Testing using a drug approved for iontophoretic delivery, or a
non-drug solution if identified in the labeling;
    b. testing of the ability of the device to maintain a safe pH
level; and
    c. if used in the ear, testing of the mechanical safety of the
device.
    2. Labeling must include adequate instructions for use, including
sufficient information for the health care provider to determine the
device characteristics that affect delivery of the drug or solution and
to select appropriate drug or solution dosing information for
administration by iontophoresis. This includes the following:
    a. A description and/or graphical representation of the electrical
output;
    b. a description of the electrode materials and pH buffer;
    c. when intended for general drug delivery, language referring the
user to approved drug labeling to determine if the drug they intend to
deliver is specifically approved for use with that type of device and
to obtain relevant dosing information; and
    d. a detailed summary of the device-related and procedure-related
complications pertinent to use of the device, and appropriate warnings
and contraindications, including the following warning:

Warning: Potential systemic adverse effects may result from use of this
device. Drugs or solutions delivered with this device have the
potential to reach the blood stream and cause systemic effects.
Carefully read all labeling of the drug or solution used with this
device to understand all potential adverse effects and to ensure
appropriate dosing information. If systemic manifestations occur, refer
to the drug or solution labeling for appropriate action.

    3. Appropriate analysis/testing must demonstrate electromagnetic
compatibility, electrical safety, thermal safety, and mechanical
safety. The requirement would, in concert with other special controls,
help ensure the mitigation of cardiac events and discomfort, pain, and
tenderness resulting from burns to the skin due to excessive energy
deposition. In addition, this requirement would ensure the device does
not interfere with other electrical equipment or medical devices and
would also ensure that both operators and users are properly protected
from electrical hazards such as electrical shock.
    4. Appropriate software verification, validation, and hazard
analysis must be performed. This requirement would help mitigate the
risk of insufficient or excessive delivery of drugs or non-drug
solutions.
    5. The elements of the device that may contact the patient must be
demonstrated to be biocompatible. These devices can contact users' and
patients' skin directly; therefore, a demonstration of biocompatibility
would mitigate the risks of skin reactions. Conditions of device
operation, such as application of electrical current, may influence
biocompatibility and should be considered in any biocompatibility
determination.
    6. The elements of the device that may contact the patient must be
assessed for sterility to ensure the risk of infection is mitigated.
    7. Performance data must support the shelf life of the elements of
the device that may be affected by aging by demonstrating continued
package integrity and device functionality over the stated shelf life.
    Table 1 shows how FDA believes that the risks to health identified
in section V can be mitigated by the proposed special controls. Under
Sec.  807.81 (21 CFR 807.81), these devices would also continue to be
subject to 510(k) notification requirements.

  Table 1--Health Risks and Mitigation Measures for Sec.   890.5525(b)
                          Iontophoresis Devices
------------------------------------------------------------------------
              Identified risk                    Mitigation measures
------------------------------------------------------------------------
Burns.....................................  Performance Testing.
                                            Electrical Safety Testing.
                                            Shelf Life Testing.
                                            Labeling.
Electrical Shock..........................  Electrical Safety Testing.
                                            Shelf Life Testing.
                                            Labeling.
Insufficient or Excessive Delivery........  Performance Testing.
                                            Software Verification,
                                             Validation and Hazards
                                             Analysis.
                                            Labeling.
Interference with Other Medical Devices...  Electromagnetic
                                             Compatibility Testing.
                                            Labeling.
Adverse Tissue Reactions..................  Biocompatibility.
Infection.................................  Sterility.
                                            Shelf Life Testing.
Ear Trauma (only when used in the ear)....  Performance Testing.
                                            Labeling.
------------------------------------------------------------------------

    In addition, iontophoresis devices are restricted to patient use
only upon the authorization of a practitioner licensed by law to
administer or use the device. (Proposed Sec.  890.5525(b); Sec.
801.109 (Prescription devices)). Under Sec.  807.81,

these devices would continue to be subject to 510(k) notification
requirements.

IX. 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.

X. Paperwork Reduction Act of 1995

    This proposed order refers to currently approved collections of
information found in FDA regulations. 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 part 807, subpart E, have been approved
under OMB control number 0910-0120; the collections of information in
21 CFR part 814, subpart B, have been approved under OMB control number
0910-0231; and the collections of information under 21 CFR part 801
have been approved under OMB control number 0910-0485. In addition, FDA
concludes that the labeling statement proposed in this order does not
constitute a ``collection of information'' under the PRA. Rather, the
labeling statement is ``public disclosure(s) of information originally
supplied by the Federal government to the recipient for the purpose of
disclosure to the public . . .'' (5 CFR 1320.3(c)(2)).
    No burden shift is associated with the reclassification of the
device. This is currently a class III device for which manufacturers
must submit a premarket notification (510(k)). This order proposes to
reclassify the device into class II, therefore, respondents would
continue to submit a premarket notification.

XI. Codification of Orders

    Prior to the amendments by FDASIA, section 513(e) of the FD&C Act
provided for FDA to issue regulations to reclassify devices. Although
section 513(e) of the FD&C Act as amended requires FDA to issue final
orders rather than regulations, FDASIA also provides for FDA to revoke
previously issued regulations by order. FDA will continue to codify
classifications and reclassifications in the Code of Federal
Regulations (CFR). Changes resulting from final orders will appear in
the CFR as changes to codified classification determinations or as
newly codified orders. Therefore, under section 513(e)(1)(A)(i), as
amended by FDASIA, in this proposed order we are proposing to revoke
the requirements in Sec.  890.5525(b)(1) related to the classification
of iontophoresis devices not intended for use with a specific drug as
class III devices and to codify their reclassification into class II
(special controls).

XII. Proposed Effective Date

    FDA is proposing that any final order based on this proposed order
become effective on the date of its publication in the Federal Register
or at a later date if stated in the final order.

XIII. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

XIV. Reference

    The following reference has been placed on display in the Division
of Dockets Management (see ADDRESSES), and may be seen by interested
persons between 9 a.m. and 4 p.m., Monday through Friday, and is
available electronically at http://www.regulations.gov. (FDA has
verified the Web site address in this reference section, but we are not
responsible for any subsequent changes to the Web site after this
document publishes in the Federal Register.)

1. Meeting Materials for the February 21, 2014, meeting of the
Orthopaedic and Rehabilitation Devices Panel, available at: http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/OrthopaedicandRehabilitationDevicesPanel/ucm386335.htm.

List of Subjects in 21 CFR Part 890

    Medical devices, Physical medicine devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR part 890 be amended as follows:

PART 890--PHYSICAL MEDICINE DEVICES

0
1. The authority citation for 21 CFR part 890 continues to read as
follows:

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

0
2. Amend Sec.  890.5525 by revising paragraph (b) and removing
paragraph (c) to read as follows:

Sec.  890.5525  Iontophoresis device.

* * * * *
    (b) Iontophoresis device intended for any other purposes--(1)
Identification. An iontophoresis device intended for any other purposes
is a prescription device that is intended to use a current to introduce
ions of drugs or non-drug solutions into the body for medical purposes
other than those specified in paragraph (a) of this section, meaning
that the device is not intended for use in diagnosis of cystic
fibrosis, and a specific drug is not specified in the labeling of the
iontophoresis device. Iontophoresis devices included in this
classification may be intended to deliver non-drug solutions.
    (2) Classification. Class II (special controls). The special
controls for this device are:
    (i) Performance testing must provide a reasonable assurance of
safety and effectiveness of the device, including:
    (A) Testing using a drug approved for iontophoretic delivery, or a
non-drug solution if identified in the labeling;
    (B) testing of the ability of the device to maintain a safe pH
level; and
    (C) if used in the ear, testing of the mechanical safety of the
device.
    (ii) Labeling must include adequate instructions for use, including
sufficient information for the health care provider to determine the
device characteristics that affect delivery of the drug or solution and
to select appropriate drug or solution dosing information for
administration by iontophoresis. This includes the following:
    (A) A description and/or graphical representation of the electrical
output;
    (B) a description of the electrode materials and pH buffer;
    (C) when intended for general drug delivery, language referring the
user to approved drug labeling to determine if the drug they intend to
deliver is specifically approved for use with that type of device and
to obtain relevant dosing information; and
    (D) a detailed summary of the device-related and procedure-related
complications pertinent to use of the device, and appropriate warnings
and contraindications, including the following warning:

Warning: Potential systemic adverse effects may result from use of this
device. Drugs or solutions delivered with this device have the
potential to reach the blood stream and cause systemic effects.
Carefully read all labeling of the drug or solution used with this
device to understand all potential adverse effects and to ensure
appropriate dosing information. If systemic manifestations occur, refer
to the drug or solution labeling for appropriate action.

    (iii) Appropriate analysis/testing must demonstrate electromagnetic
compatibility, electrical safety, thermal safety, and mechanical
safety.
    (iv) Appropriate software verification, validation, and hazard
analysis must be performed.
    (v) The elements of the device that may contact the patient must be
demonstrated to be biocompatible.
    (vi) The elements of the device that may contact the patient must
be assessed for sterility.
    (vii) Performance data must support the shelf life of the elements
of the device that may be affected by aging by demonstrating continued
package integrity and device functionality over the stated shelf life.

    Dated: September 15, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-22453 Filed 9-19-14; 8:45 am]
BILLING CODE 4164-01-P


			  UNITED STATES OF AMERICA

		        DEPARTMENT OF TRANSPORTATION

			  OFFICE OF THE SECRETARY

			          WASHINGTON, D.C.

Issued by the Department of Transportation on May 24, 2004

NOTICE OF ACTION TAKEN -- DOCKET OST-2003-14801

________________________________________________________________________
________________________________________________________

This serves as notice to the public of the action described below, taken
by the Department official indicated (no additional confirming order
will be issued in this matter).

Applicant:  GESTAIR, S.A.
                                                  Date Filed:  March 24,
2004

Relief requested:  Exemption from 49 USC section 41301 to permit the
applicant to conduct, using small equipment (see below), charter
operations, carrying persons, property and mail, between Spain and the
United States, and other charters, in accordance with 14 CFR Part 212.

If renewal, date and citation of last action:  April 15, 2003, in this
Docket.

Applicant representative(s):  Lee A. Bauer,<PHONE_NUMBER>        DOT
analyst:  Allen F. Brown,<PHONE_NUMBER>

Responsive pleadings:  None.

	DISPOSITION

Action:  Approved.			   			                    Action date:  May 24,
2004

Effective dates of authority granted:  May 24, 2004, through May 24,
2005.

Basis for approval (bilateral agreement/reciprocity):  Reciprocity with
Spain.

Except to the extent exempted/waived, this authority is subject to the
terms, conditions, and limitations indicated:  Standard exemption
conditions.

Special conditions/Remarks:  In the conduct of these operations, GESTAIR
may only use aircraft designed to have a maximum passenger capacity of
not more than 60 seats and a maximum payload capacity of not more than
18,000 pounds (small equipment).  The above grant included authority to
conduct Third and Fourth Freedom charters, without prior approval.
Other charter operations to and/or from the United States under this
authority, however, are subject to prior approval under 14 CFR Part 212.

Action taken by:   Paul L. Gretch, Director, Office of International
Aviation

________________________________________________________________________
______________________________________________________

Under authority assigned by the Department in its regulations, 14 CFR
Part 385, we found that (1) our action was consistent with Department
policy; (2) the applicant was qualified to perform its proposed
operations; (3) grant of the authority was consistent with the public
interest; and (4) grant of the authority would not constitute a major
regulatory action under the Energy Policy and Conservation Act of 1975.
To the extent not granted/deferred/dismissed, we denied all requests in
the referenced Docket.  We may amend, modify, or revoke the authority
granted in this Notice at any time without hearing at our discretion.

Persons entitled to petition the Department for review of the action set
forth in this Notice under the Department’s regulations, 14 CFR
§385.30, may file their petitions within seven (7) days after the date
of issuance of this Notice.  This action was effective when taken, and
the filing of a petition for review will not alter such effectiveness.

An electronic version of this document is available on the World Wide
Web at:

http://dms.dot.gov//reports/reports_aviation.asp


[Federal Register Volume 80, Number 246 (Wednesday, December 23, 2015)]
[Notices]
[Pages 79984-79986]
[FR Doc No: 2015-32186]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-76672; File No. SR-CBOE-2015-113]

Self-Regulatory Organizations; Chicago Board Options Exchange,
Incorporated; Notice of Filing and Immediate Effectiveness of a
Proposed Rule Change Relating to the Technical Disconnect Mechanism

December 17, 2015.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that, on December 8, 2015, Chicago Board Options Exchange, Incorporated
(the ``Exchange'' or ``CBOE'') filed with the Securities and Exchange
Commission (``Commission'') the proposed rule change as described in
Items I, II and III below, which Items have been prepared by the
Exchange. The Commission is publishing this notice to solicit comments
on the proposed rule change from interested persons.
---------------------------------------------------------------------------

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

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

    The Exchange proposes to amend Rule 6.23C related to the Exchange's
Technical Disconnect Mechanism. The text of the proposed rule change is
provided below.
(additions are italicized; deletions are [bracketed])
* * * * *
Chicago Board Options Exchange, Incorporated Rules
* * * * *
Rule 6.23C Technical Disconnect

    (a) When a CBOE Application Server (``CAS'') loses communication
with a Client Application such that a CAS does not receive an
appropriate response to a Heartbeat Request within ``x'' period of
time, the Technical Disconnect Mechanism will automatically logoff the
Trading Permit Holder's affected Client Application and automatically
cancel all the Trading Permit Holder's Market-Maker quotes, if
applicable, and open orders with a time-in-force of ``day'' resting in
the Book (which excludes orders resting on a PAR workstation or order
management terminal) (``day orders''), if the Trading Permit Holder
enables that optional service, posted through the affected Client
Application. The following describes how the Technical Disconnect
Mechanism works for each of the Exchange's application programming
interfaces (``APIs''):
    (i)-(ii) No change.
    (b)-(c) No change.
    . . . Interpretations and Policies:
    .01 No change.
* * * * *
    The text of the proposed rule change is also available on the
Exchange's Web site (http://www.cboe.com/AboutCBOE/CBOELegalRegulatoryHome.aspx), at the Exchange's Office of the
Secretary, and at the Commission's Public Reference Room.

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

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

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

1. Purpose
    Rule 6.23C(a) provides that when a CBOE Application Server
(``CAS'') \3\ loses communication with a Client Application \4\ such
that a CAS does not receive an appropriate response to a Heartbeat
Request \5\ within ``x'' period of time, the Technical Disconnect
Mechanism will automatically logoff the Trading Permit Holder's
(``TPH'') affected Client Application. If that occurs, the current rule
provides that the Technical Disconnect Mechanism, if applicable, will
automatically cancel all the TPH's Market-Maker quotes posted through
the affected Client

Application.\6\ The Technical Disconnect Mechanism is intended to help
mitigate the potential risks associated with a loss of communication
with a Client Application, such as erroneous or unintended executions
for stale quotes that are resting in the CBOE book. This mechanism
serves to assist a TPH when a technical or system issue occurs, as well
as assist the Exchange in maintaining a fair and orderly market.
---------------------------------------------------------------------------

    \3\ CBOE currently has numerous CASs serving TPHs.
    \4\ For relevant purposes, a ``Client Application'' is the
system component, such as a CBOE-supported workstation or a TPH's
custom trading application, through which a TPH communicates its
quotes and/or orders to a CAS. Messages are passed between a Client
Application and a CAS. A Market-Maker may send quotes to the
Exchange from one or more Client Applications, and a TPH may send
orders to the Exchange from one or more Client Applications.
    \5\ A ``Heartbeat Request'' refers to a message from a CAS to a
Client Application to check connectivity and which requires a
response from the Client Application in order to avoid logoff. The
Heartbeat Request acts as a virtual pulse between a CAS and a Client
Application and allows a CAS to continually monitor its connection
with a Client Application. Failure to receive a response to a
Heartbeat Request within the Heartbeat Response Time is indicative
of a technical or system issue.
    \6\ See Rule 6.23C and Securities Exchange Act Release No. 34-
70039 (July 25, 2013), 78 FR 46395 (July 31, 2013) (SR-CBOE-2013-
071) for further information regarding the Technical Disconnect
Mechanism.
---------------------------------------------------------------------------

    Recently, the Exchange amended Rule 6.23C related to the Technical
Disconnect Mechanism to provide TPHs with an optional service that, if
enabled by a TPH, will cause the Technical Disconnect Mechanism to also
automatically cancel all the TPH's open orders with a time-in-force of
``day'' (``day orders'') posted through the affected Client Application
if the CAS loses communication with the Client Application.\7\ This
optional service is an additional preventative risk control measure
that CBOE is making available to TPHs. It is intended to help further
mitigate the potential risks associated with a loss of communication
with a TPH's Client Application. If a TPH's Client Application is
disconnected for any period of time, it is possible that market
conditions upon which it based its day orders may change during that
time and make those orders stale. Consequently, any resulting
executions of those orders may be erroneous or unintended.
---------------------------------------------------------------------------

    \7\ See Securities Exchange Act Release No. 34-76489 (November
20, 2015), 80 FR 74149 (November 27, 2015) (SR-CBOE-2015-103). The
Exchange has not yet implemented this optional service and will
announce the implementation date of the service, including the
proposed rule change, by Regulatory Circular.
---------------------------------------------------------------------------

    The proposed rule change provides that this optional service will
automatically cancel open orders with a time-in-force of day that are
resting on the book, but not resting on a PAR workstation or order
management terminal (``OMT'').\8\ A TPH's day orders resting in the
book may automatically execute against incoming quotes or orders and
are thus subject to the risk of potential erroneous or unintended
executions if the CAS loses communication with the TPH's Client
Application, which risk the optional service is intended to mitigate.
However, the TPH's day orders resting on a PAR workstation or OMT are
subject to manual handling by a broker, agent or PAR official, as
applicable, and are not subject to automatic execution against incoming
quotes or orders. This manual handling mitigates the risk of potential
erroneous or unintended executions of those orders, even during a time
when the TPH is disconnected from the CAS, as an individual can
determine how to handle the orders in accordance with CBOE's rules. The
Exchange believes it is appropriate to have the Technical Disconnect
Mechanism cancel only day orders resting on the book but not day orders
resting on a PAR workstation or OMT terminal, since manual handling of
those orders has already mitigated the applicable risk.
---------------------------------------------------------------------------

    \8\ See Rule 6.12 regarding CBOE's hybrid order handling system,
including when orders may be routed to a PAR workstation or OMT via
the order handling system.
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
the Securities Exchange Act of 1934 (the ``Act'') and the rules and
regulations thereunder applicable to the Exchange and, in particular,
the requirements of Section 6(b) of the Act.\9\ Specifically, the
Exchange believes the proposed rule change is consistent with the
Section 6(b)(5) \10\ requirements that the rules of an exchange be
designed to prevent fraudulent and manipulative acts and practices, to
promote just and equitable principles of trade, to foster cooperation
and coordination with persons engaged in regulating, clearing,
settling, processing information with respect to, and facilitating
transactions in securities, to remove impediments to and perfect the
mechanism of a free and open market and a national market system, and,
in general, to protect investors and the public interest. Additionally,
the Exchange believes the proposed rule change is consistent with the
Section 6(b)(5) \11\ requirement that the rules of an exchange not be
designed to permit unfair discrimination between customers, issuers,
brokers, or dealers.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78f(b).
    \10\ 15 U.S.C. 78f(b)(5).
    \11\ Id.
---------------------------------------------------------------------------

    In particular, the proposed rule change helps maintain a fair and
orderly market, promotes efficiency and protects investors. While the
optional service to have the Technical Disconnect Mechanism cancel a
TPH's day orders mitigates the risks of potential erroneous or
unintended executions of those orders associated with a loss in
communication with a Client Application, those risks have already been
mitigated for day orders resting on a PAR workstation or OMT that are
subject to manual handling. Thus, the Exchange believes it is
reasonable to not have the Technical Disconnect Mechanism cancel those
orders and instead allow the broker, agent or PAR Official, as
applicable, to handle those orders as the individual deems appropriate
in accordance with CBOE's rules. The Exchange also believes that the
proposed rule change is designed to not permit unfair discrimination
among market participants, as it applies to all TPHs in the same
manner. The Exchange believes it is appropriate to apply this optional
cancellation functionality to day orders only resting on the book and
not day orders resting on a PAR workstation or OMT, because the latter
orders are not subject to the same risks of potential erroneous or
unintended executions as the former orders.

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

    CBOE does not believe that the proposed rule change will impose any
burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act. Specifically, the Exchange does
not believe the proposed rule change will cause any burden on
intramarket competition because the proposed rule change applies to all
TPHs in the same manner. Use of the service to cancel day orders
resting on the book in the event the CAS loses communication with a
Client Application is voluntary. Additionally, whether a TPH enables
the optional service or not, the TPH's day orders resting on a PAR
workstation or OMT will continue to be manually handled as they are
today, even if the CAS loses communication with a TPH's Client
Application. The Exchange believes it is appropriate to apply this
optional cancellation functionality to day orders resting only on the
book and not on a PAR workstation or OMT, because, as discussed above,
those orders are not subject to the same risks of potential erroneous
or unintended executions as the orders resting on the book. Further,
the Exchange does not believe that such change will impose any burden
on intermarket competition that is not necessary or appropriate in
furtherance of the purposes of the Act. The proposed rule change
modifies a mechanism available on CBOE's system and applies only to
orders resting in CBOE's book.

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

    The Exchange neither solicited nor received comments on the
proposed rule change.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A) of the Act \12\ and paragraph (f) of Rule 19b-4 \13\
thereunder. At any time within 60 days of the filing of the proposed
rule change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission will institute proceedings to
determine whether the proposed rule change should be approved or
disapproved.
---------------------------------------------------------------------------

    \12\ 15 U.S.C. 78s(b)(3)(A).
    \13\ 17 CFR 240.19b-4(f).
---------------------------------------------------------------------------

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-CBOE-2015-113 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.

All submissions should refer to File Number SR-CBOE-2015-113. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of the filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-CBOE-2015-113 and should be
submitted on or before January 13, 2016.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\14\
---------------------------------------------------------------------------

    \14\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Robert W. Errett,
Deputy Secretary.
[FR Doc. 2015-32186 Filed 12-22-15; 8:45 am]
BILLING CODE 8011-01-P


EE Initial Notification Summary Information 		O3 Template
Submitting Agency: Tehama APCD
Agency Contact: Peter Helldorfer
Date Submitted:  2/19/2021
Applicable NAAQS:  2015 8-Hour Ozone
Affected Regulatory Decision[1]: Attainment Determination for 2015 8-Hour Ozone
 (for classification decisions, specify level of the classification with/without EE concurrence)
Area Name/Designation Status: Tehama County, California  -  Tuscan Buttes - Nonattainment Area
Design Value Period (list three year period): 2018-2020
 (where there are multiple relevant design value periods, summarize separately)

A) See attached spreadsheet titled "Federal Exceptional Event Initial Notification Sheet 2018-2020"

B) Violating Sites Information
  (listing of all violating sites in the planning area, regardless of operating agency, and regardless of whether or not they are impacted by EEs)
Site/monitor (AQS ID and POC)

Design Value (without EPA concurrence on any of the events listed in attached spreadsheet)
Design Value (with EPA concurrence on all events listed in attached spreadsheet)
Tuscan Buttes AQS: 061030004-1
                                    74 ppb
                                    67 ppb

C) Summary of Maximum Design Value (DV) Site Information (Effect of EPA Concurrence on Maximum Design Value Site Determination)
   (Two highest values from Table B)
Maximum DV site (AQS ID) without EPA concurrence on any of the  events listed in attached spreadsheet
                                Design Value
                                      74
                               Design Value Site
                                 Tuscan Buttes
                                    Comment
Maximum DV site (AQS ID)  with EPA concurrence on all events listed in attached spreadsheet
                                 Design Value
                                      67
                               Design Value Site
                                 Tuscan Buttes
                                    Comment
            Site would meet attainment for 2015 8-Hour Ozone NAAQS

D) List of any sites (AQS ID) within planning area with invalid design values (e.g., due to data incompleteness)