[Federal Register Volume 81, Number 112 (Friday, June 10, 2016)]
[Rules and Regulations]
[Pages 37499-37500]
[FR Doc No: 2016-13788]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 886

[Docket No. FDA-2016-N-1308]

Medical Devices; Ophthalmic Devices; Classification of
Nasolacrimal Compression Device

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA) is classifying the
nasolacrimal compression device into class I (general controls). The
Agency is classifying the device into class I (general controls) in
order to provide a reasonable assurance of safety and effectiveness of
the device.

DATES: This order is effective June 10, 2016. The classification was
applicable on April 20, 2016.

FOR FURTHER INFORMATION CONTACT: Daniel Fedorko, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 2414, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In accordance with section 513(f)(1) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were
not in commercial distribution before May 28, 1976 (the date of
enactment of the Medical Device Amendments of 1976), generally referred
to as postamendments devices, are classified automatically by statute
into class III without any FDA rulemaking process. These devices remain
in class III and require premarket approval, unless and until the
device is classified or reclassified into class I or II, or FDA issues
an 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) of the regulations.
    Section 513(f)(2) of the FD&C Act, as amended by section 607 of the
Food and Drug Administration Safety and Innovation Act (Pub. L. 112-
144), provides two procedures by which a person may request FDA to
classify a device under the criteria set forth in section 513(a)(1) of
the FD&C Act. Under the first procedure, the person submits a premarket
notification under section 510(k) of the FD&C Act for a device that has
not previously been classified and, within 30 days of receiving an
order classifying the device into class III under section 513(f)(1) of
the FD&C Act, the person requests a classification under section
513(f)(2). Under the second procedure, rather than first submitting a
premarket notification under section 510(k) of the FD&C Act and then a
request for classification under the first procedure, the person
determines that there is no legally marketed device upon which to base
a determination of substantial equivalence and requests a
classification under section 513(f)(2) of the FD&C Act. If the person
submits a request to classify the device under this second procedure,
FDA may decline to undertake the classification request if FDA
identifies a legally marketed device that could provide a reasonable
basis for review of substantial equivalence with the device or if FDA
determines that the device submitted is not of ``low-moderate risk'' or
that general controls would be inadequate to control the risks and
special controls to mitigate the risks cannot be developed.
    In response to a request to classify a device under either
procedure provided by section 513(f)(2) of the FD&C Act, FDA will
classify the device by written order within 120 days. This
classification will be the initial classification of the device.
    On June 27, 2014, Innovatex, Inc., submitted a request for
classification of the Tear Duct Occluder (originally referred to as the
Glaucoma Companion Nasolacrimal Compression Device) under section
513(f)(2) of the FD&C Act. The manufacturer recommended that the device
be classified into class I (Ref. 1).
    In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed
the request in order to classify the device under the criteria for
classification set forth in section 513(a)(1) of the FD&C Act. FDA
classifies devices into class I if general controls by themselves are
sufficient to provide reasonable assurance of safety and effectiveness
of the device for its intended use. After review of the information
submitted in the de novo request, FDA determined that the device can be
classified into class I. FDA believes general controls will provide
reasonable assurance of the safety and effectiveness of the device.
    Therefore, on April 20, 2016, FDA issued an order to the requestor
classifying the device into class I. FDA

is codifying the classification of the device by adding 21 CFR
886.5838.
    The device is assigned the generic name nasolacrimal compression
device, and it is identified as a prescription device that is fitted to
apply mechanical pressure to the nasal aspect of the orbital rim to
reduce outflow through the nasolacrimal ducts.
    The risks to health that may be associated with use of the
nasolacrimal compression device are improper fit of the device
(extended or aggressive use of this device may cause sequelae such as
bruising and/or soreness) and improper use of the device (for the
uncoordinated, a corneal abrasion may occur inadvertently). General
controls of the FD&C Act, including compliance with the labeling
requirements in 21 CFR part 801 and the Quality System Regulation (21
CFR part 820), are sufficient to mitigate these risks and reasonably
assure safety and effectiveness. FDA believes that the general controls
provide reasonable assurance of safety and effectiveness.
    The nasolacrimal compression device is not safe for use except
under the supervision of a practitioner licensed by law to direct the
use of the device. As such, the device is a prescription device and
must satisfy prescription labeling requirements (see 21 CFR 801.109,
Prescription devices).
    Section 510(l) of the FD&C Act provides that a class I device is
not subject to the premarket notification requirements under section
510(k) of the FD&C Act, unless the device is of substantial importance
in preventing impairment of human health or presents a potential
unreasonable risk of illness or injury. FDA has determined that the
device does meet these criteria and, therefore, premarket notification
is not required for the device. Thus, persons who intend to market this
device need not submit a premarket notification containing information
on the nasolacrimal compression device they intend to market prior to
marketing the device, subject to the limitations on exemptions in 21
CFR 886.9.

II. Analysis of Environmental Impact

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

III. Paperwork Reduction Act of 1995

    This final order refers to previously approved collections of
information found in other 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, regarding
premarket notification submissions, have been approved under OMB
control number 0910-0120; the collections of information in 21 CFR part
820, regarding the quality system regulation, have been approved under
OMB control number 0910-0073; and the collections of information in 21
CFR part 801, regarding labeling, have been approved under OMB control
number 0910-0485.

IV. Reference

    The following reference is on display in the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, and is available for viewing by
interested persons between 9 a.m. and 4 p.m., Monday through Friday; it
is also available electronically at http://www.regulations.gov.

    1. DEN140022: De novo request from Innovatex, Inc., dated June
27, 2014.

List of Subjects in 21 CFR Part 886

    Medical devices, Ophthalmic goods and services.

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

PART 886--OPHTHALMIC DEVICES

0
1. The authority citation for 21 CFR part 886 continues to read as
follows:

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

0
2. Add Sec.  886.5838 to subpart F to read as follows:

Sec.  886.5838  Nasolacrimal compression device.

    (a) Identification. A nasolacrimal compression device is a
prescription device that is fitted to apply mechanical pressure to the
nasal aspect of the orbital rim to reduce outflow through the
nasolacrimal ducts.
    (b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter, subject to the limitations in Sec.  886.9.

    Dated: June 6, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-13788 Filed 6-9-16; 8:45 am]
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[Federal Register Volume 85, Number 13 (Tuesday, January 21, 2020)]
[Notices]
[Pages 3435-3437]
[FR Doc No: 2020-00802]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-87964; File No. SR-MIAX-2020-01]

Self-Regulatory Organizations; Miami International Securities
Exchange LLC; Notice of Filing and Immediate Effectiveness of a
Proposed Rule Change To Amend Its Fee Schedule

January 14, 2020.
    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 January 3, 2020, Miami International Securities Exchange LLC (``MIAX
Options'' or ``Exchange'') filed with the Securities and Exchange
Commission (``SEC'' or ``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.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange is filing a proposal to amend the MIAX Options Fee
Schedule (the ``Fee Schedule'').
    The text of the proposed rule change is available on the Exchange's
website at http://www.miaxoptions.com/rule-filings, at MIAX's principal
office, 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
    The Exchange proposes to amend the list of MIAX Select Symbols \3\
contained in the Priority Customer Rebate Program (the ``Program'') \4\
of the Exchange's Fee Schedule to delete the Select Symbols ``CELG,''
``HTZ'' and ``WY'' from the Select Symbols list.
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    \3\ The term ``MIAX Select Symbols'' means options overlying
AAL, AAPL, AIG, AMAT, AMD, AMZN, BA, BABA, BB, BIDU, BP, C, CAT,
CELG, CLF, CVX, DAL, EBAY, EEM, FB, FCX, GE, GILD, GLD, GM, GOOGL,
GPRO, HAL, HTZ, INTC, IWM, JCP, JNJ, JPM, KMI, KO, MO, MRK, NFLX,
NOK, ORCL, PBR, PFE, PG, QCOM, QQQ, RIG, S, SPY, T, TSLA, USO, VALE,
WBA, WFC, WMB, WY, X, XHB, XLE, XLF, XLP, XOM and XOP.
    \4\ See section 1(a)(iii) of the Fee Schedule for a complete
description of the Program.
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    The Exchange initially created the list of MIAX Select Symbols on
March 1, 2014,\5\ and has added and removed option classes from that
list since that time.\6\ Select Symbols are rebated slightly higher in
certain Program tiers than non-Select Symbols. The Exchange notes that
historically, Select Symbols generally include a subset of classes of
options that are included in the Penny Pilot Program, an industry-wide
pilot program that provides for the quoting and trading of certain
option classes in penny increments (the ``Penny Pilot Program''). The
Penny Pilot Program allows the quoting and trading of certain option
classes in minimum increments of $0.01 for all series in such option
classes with a price of less than $3.00; and in minimum increments of
$0.05 for all series in such option classes with a price of $3.00 or
higher. The Penny Pilot Program was initiated at the then existing
option exchanges in January 2007 \7\ and currently includes more than
300 of the most active option classes.
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    \5\ See Securities Exchange Act Release No. 71700 (March 12,
2014), 79 FR 15188 (March 18, 2014) (SR-MIAX-2014-13).
    \6\ See Securities Exchange Act Release Nos. 87790 (December 18,
2019), 84 FR 71037 (December 26, 2019) (SR-MIAX-2019-49); 85314
(March 14, 2019), 84 FR 10359 (March 20, 2019) (SR-MIAX-2019-07;
81998 (November 2, 2017), 82 FR 51897 (November 8, 2017) (SR-MIAX-
2017-45); 81019 (June 26, 2017), 82 FR 29962 (June 30, 2017) (SR-
MIAX-2017-29); 79301 (November 14, 2016), 81 FR 81854 (November 18,
2016) (SR-MIAX-2016-42); 74291 (February 18, 2015), 80 FR 9841
(February 24, 2015) (SR-MIAX-2015-09); 74288 (February 18, 2015), 80
FR 9837 (February 24, 2015) (SR-MIAX-2015-08); 73328 (October 9,
2014), 79 FR 62230 (October 16, 2014) (SR-MIAX-2014-50); 72567 (July
8, 2014), 79 FR 40818 (July 14, 2014) (SR-MIAX-2014-34); 72356 (June
10, 2014), 79 FR 34384 (June 16, 2014) (SR-MIAX-2014-26); 71700
(March 12, 2014), 79 FR 15188 (March 18, 2014) (SR-MIAX-2014-13).
    \7\ See Securities Exchange Act Release Nos. 55154 (January 23,
2007), 72 FR 4743 (February 1, 2007) (SR-CBOE-2006-92); 55161
(January 24, 2007), 72 FR 4754 (February 1, 2007) (SR-ISE-2006-62);
54886 (December 6, 2006), 71 FR 74979 (December 13, 2006) (SR-Phlx-
2006-74); 54590 (October 12, 2006), 71 FR 61525 (October 18, 2006)
(SR-NYSEArca-2006-73); and 54741 (November 9, 2006), 71 FR 67176
(November 20, 2006) (SR-Amex-2006-106). See also Exchange Rule 510,
Interpretation and Policy .01.
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    The Exchanges notes that current Select Symbol ``CELG'' will no
longer be included in the Penny Pilot Program industry-wide beginning
January 3, 2020 and Select Symbols ``HTZ'' and ``WY'' are no longer in
the Penny Pilot Program. Accordingly, for business and competitive
reasons, the Exchange proposes to amend the Fee Schedule to delete the
symbols ``CELG,'' ``HTZ'' and ``WY'' from the list of MIAX Select
Symbols contained in the Program as those Select Symbols are no longer
in the Penny Pilot Program.XYZ

2. Statutory Basis
    The Exchange believes that its proposal to amend the Fee Schedule
is consistent with Section 6(b) of the Act \8\ in general, and furthers
the objectives of Section 6(b)(4) of the Act,\9\ in that it is an
equitable allocation of reasonable dues, fees and other charges among
Exchange members and issuers and other persons using its facilities,
and 6(b)(5) of the Act,\10\ in that it is designed to promote just and
equitable principles of trade, 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 and is not
designed to permit unfair discrimination between customers, issuers,
brokers and dealers.
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    \8\ 15 U.S.C. 78f(b).
    \9\ 15 U.S.C. 78f(b)(4).
    \10\ 15 U.S.C. 78f(b)(1) and (b)(5).
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    In particular, the proposal to delete the symbols ``CELG,'' ``HTZ''
and ``WY'' from the list of MIAX Select Symbols contained in the
Program is consistent with Section 6(b)(4) of the Act because the
proposed changes will allow for continued benefit to investors by
providing them an updated list of MIAX Select Symbols contained in the
Program on the Fee Schedule.
    The Exchange believes that the proposal to amend an option class
that qualifies for the credit for transactions in MIAX Select Symbols
is fair, equitable and not unreasonably discriminatory. The Exchange
believes that the Program itself is reasonably designed because it
incentivizes providers of Priority Customer \11\ order flow to send
that Priority Customer order flow to the Exchange in order to receive a
credit in a manner that enables the Exchange to improve its overall
competitiveness and strengthen its market quality for all market
participants. The Program, which provides increased incentives in
certain tiers in high volume select symbols, is also reasonably
designed to increase the competitiveness of the Exchange with other
options exchanges that also offer increased incentives to higher volume
symbols.
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    \11\ The term ``Priority Customer'' means a person or entity
that (i) is not a broker or dealer in securities, and (ii) does not
place more than 390 orders in listed options per day on average
during a calendar month for its own beneficial account(s). See
Exchange Rule 100.
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    The Exchange also believes that its proposal is consistent with
Section 6(b)(5) of the Act because it will apply equally to all
Priority Customer orders in MIAX Select Symbols in the Program. All
similarly situated Priority Customer orders in MIAX Select Symbols are
subject to the same rebate schedule, and access to the Exchange is
offered on terms that are not unfairly discriminatory.

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

    The Exchange does not believe that the proposed rule change will
result in any burden on competition that is not necessary or
appropriate in furtherance of the purposes of the Act. The proposed
rule change should enable the Exchange to continue to attract and
compete for order flow with other exchanges. Notwithstanding the
removal of the symbols CELG, HTZ and WY from the Select Symbols list,
the Exchange's rebates remain highly competitive with those of other
exchanges, and therefore should enable the Exchange to continue to
attract and compete for order flow with other exchanges which offer
comparable rebates for particular symbols. The Exchange notes that it
operates in a highly competitive market in which market participants
can readily favor competing venues if they deem fee levels at a
particular venue to be excessive. In such an environment, the Exchange
must continually adjust its fees and rebates to remain competitive with
other exchanges and to attract order flow.

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

    Written comments were neither solicited nor received.

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)(ii) of the Act,\12\ and Rule 19b-4(f)(2) \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 shall institute proceedings to determine whether
the proposed rule should be approved or disapproved.
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    \12\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \13\ 17 CFR 240.19b-4(f)(2).
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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-MIAX-2020-01 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-MIAX-2020-01. 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 website (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 website 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. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-MIAX-2020-01, and should be submitted on
or before February 11, 2020.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\14\
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    \14\ 17 CFR 200.30-3(a)(12).
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J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2020-00802 Filed 1-17-20; 8:45 am]
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