[Federal Register Volume 86, Number 241 (Monday, December 20, 2021)]
[Notices]
[Pages 71978-71980]
[FR Doc No: 2021-27428]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-93779; File No. SR-MRX-2021-12]

Self-Regulatory Organizations; Nasdaq MRX, LLC; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Amend MRX's
Pricing Schedule at Options 7, Section 1, General Provisions

December 14, 2021.
    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 1, 2021, Nasdaq MRX, LLC (``MRX'' 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 proposes to amend MRX's Pricing Schedule at Options 7,
Section 1, General Provisions.
    While the changes proposed herein are effective upon filing, the
Exchange has designated the amendments become operative on December 1,
2021.
    The text of the proposed rule change is available on the Exchange's
website at https://listingcenter.nasdaq.com/rulebook/mrx/rules, at the
principal office of the Exchange, 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
    MRX proposes to amend its Pricing Schedule at Options 7, Section 1,
General Provisions. Specifically, MRX proposes to amend the way an
Exchange Member indicates its participation in the Affiliated Entity
Program. Specifically, the Exchange proposes to amend the description
of ``Affiliated Entity'' within Options 7, Section 1, General
Provisions. Currently, the term ``Affiliated Entity'' is described as,

a relationship between an Appointed Market Maker and an Appointed
OFP for purposes of qualifying for certain pricing specified in the
Pricing Schedule. Market Makers and OFPs are required to send an
email to the Exchange to appoint their counterpart, at least 3
business days prior to the last day of the month to qualify for the
next month. The Exchange will acknowledge receipt of the emails and
specify the date the Affiliated Entity is eligible for applicable
pricing, as specified in the Pricing Schedule. Each Affiliated
Entity relationship will commence on the 1st of a month and may not
be terminated prior to the end of any month. An Affiliated Entity
relationship will terminate after a one (1) year period, unless
either party terminates earlier in writing by sending an email to
the Exchange at least 3 business days prior to the last day of the
month to terminate for the next month. Affiliated Entity
relationships must be renewed annually by each party sending an
email to the Exchange. Affiliated Members may not qualify as a
counterparty comprising an Affiliated Entity. Each Member may
qualify for only one (1) Affiliated Entity relationship at any given
time.

    Today, Members are required to annually renew their Affiliate
Entity relationship at the end of one year if they desire to continue
the relationship. The parties must both send an email to the Exchange
to avoid termination of the relationship, provided the relationship was
not terminated earlier in the year. The Exchange believes that this
process is burdensome for Members that desire to remain in the program.
The consequence of not renewing is termination. The Exchange desires to
remove the administrative burden associated with the requirement to
annually renew and instead provide that the Affiliated Entity
relationship will automatically renew each month, unless otherwise
terminated. The proposed new rule text would provide,

    An ``Affiliated Entity'' is a relationship between an Appointed
Market Maker and an Appointed OFP for purposes of qualifying for
certain pricing specified in the Pricing Schedule. Market Makers and
OFPs are required to send an email to the Exchange to appoint their
counterpart, at least 3 business days prior to the last day of the
month to qualify for the next month. The Exchange will acknowledge
receipt of the emails and specify the date the Affiliated Entity is
eligible for applicable pricing, as specified in the Pricing
Schedule. Each Affiliated Entity relationship will commence on the
1st of a month and may not be terminated prior to the end of any
month. An Affiliated Entity relationship will automatically renew
each month until or unless either party terminates earlier in
writing by sending an email to the Exchange at least 3 business days
prior to the last day of the month to terminate for the next month.
Affiliated Members may not qualify as a counterparty comprising an
Affiliated Entity. Each Member may qualify for only one (1)
Affiliated Entity relationship at any given time.

    As is the case today, parties to the Affiliated Entity relationship
may decide to terminate the relationship during any month by sending an
email to the Exchange at least 3 business days prior to the last day of
the month to terminate for the next month. Cboe Exchange, Inc.
(``Cboe'') has a similar automatic renewal process for its Appointed
OFP and Appointed Market-Maker Program.\3\ The Exchange believes

that this amendment will streamline the workflow for Members by not
requiring Members to renew each year to continue the affiliated
relationship.
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    \3\ See Cboe's Fees Schedule at footnote 23 ``A Market-Maker may
designate an Order Flow Provider (``OFP'') as its ``Appointed OFP''
and an OFP may designate a Market-Maker to be its ``Appointed
Market-Maker'' for purposes of qualifying for credits under AVP. In
order to effectuate the appointment, the parties would need to
submit the Appointed Affiliate Form to the Exchange by 3:00 p.m. CST
on the first business day of the month in order to be eligible to
qualify for credits under AVP for that month. The Exchange will
recognize only one such designation for each party once every
calendar month, which designation will automatically renew each
month until or unless the Exchange receives an email from either
party indicating that the appointment has been terminated. A Market-
Maker that has both an Affiliate OFP and Appointed OFP will only
qualify based upon the volume of its Appointed OFP. The volume of an
OFP that has both an Affiliate Market-Maker and Appointed Market-
Maker will only count towards qualifying the Appointed Market-Maker.
Volume executed in open outcry is not eligible to receive a credit
under AVP.''
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2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\4\ in general, and furthers the objectives of Sections
6(b)(4) and 6(b)(5) of the Act,\5\ in particular, in that it provides
for the equitable allocation of reasonable dues, fees, and other
charges among members and issuers and other persons using any facility,
and is not designed to permit unfair discrimination between customers,
issuers, brokers, or dealers.
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    \4\ 15 U.S.C. 78f(b).
    \5\ 15 U.S.C. 78f(b)(4) and (5).
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    The Exchange's proposal to amend the way Exchange Members indicate
their participation in the Affiliated Entity Program is reasonable.
Today, Members are required to annually renew their Affiliated Entity
relationship at the end of one year if they desire to continue the
relationship. The parties must both send an email to the Exchange to
avoid termination of the relationship, provided the relationship was
not terminated earlier in the year. The Exchange believes that this
process is burdensome for Members that desire to remain in the program.
The consequence of not renewing is termination of their participation
in the program. The Exchange desires to remove the administrative
burden associated with the requirement to annually renew and instead
provide that the Affiliated Entity relationship will automatically
renew each month, unless otherwise terminated. As is the case today,
parties to the Affiliated Entity relationship may decide to terminate
the relationship during any month by sending an email to the Exchange
at least 3 business days prior to the last day of the month to
terminate for the next month. Also, Cboe has a similar automatic
renewal process for its Appointed OFP and Appointed Market-Maker
Program.\6\ The Exchange believes that this amendment will streamline
the workflow for Members by not requiring Members to renew each year to
continue the affiliated relationship.
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    \6\ See Cboe's Fees Schedule at footnote 23 ``A Market-Maker may
designate an Order Flow Provider (``OFP'') as its ``Appointed OFP''
and an OFP may designate a Market-Maker to be its ``Appointed
Market-Maker'' for purposes of qualifying for credits under AVP. In
order to effectuate the appointment, the parties would need to
submit the Appointed Affiliate Form to the Exchange by 3:00 p.m. CST
on the first business day of the month in order to be eligible to
qualify for credits under AVP for that month. The Exchange will
recognize only one such designation for each party once every
calendar month, which designation will automatically renew each
month until or unless the Exchange receives an email from either
party indicating that the appointment has been terminated. A Market-
Maker that has both an Affiliate OFP and Appointed OFP will only
qualify based upon the volume of its Appointed OFP. The volume of an
OFP that has both an Affiliate Market-Maker and Appointed Market-
Maker will only count towards qualifying the Appointed Market-Maker.
Volume executed in open outcry is not eligible to receive a credit
under AVP.''
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    The Exchange's proposal to amend the way Exchange Member indicate
their participation in the Affiliated Entity Program is equitable and
not unfairly discriminatory. Today, any Member may participate in the
Affiliated Entity Program. The proposed changes would impact all
Members that voluntarily elect to participate in the Affiliated Entity
Program in a uniform manner.

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act.
Inter-Market Competition
    The proposal does not impose an undue burden on inter-market
competition. Cboe has a similar automatic renewal process for its
Appointed OFP and Appointed Market-Maker Program \7\ as proposed herein
for the Affiliated Entity Program.
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    \7\ Id.
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Intra-Market Competition
    The Exchange's proposal to amend the way Exchange Members indicate
their participation in the Affiliated Entity Program does not impose an
undue burden on competition. Today, any Member may participate in an
Affiliated Entity relationship. The proposed changes would impact all
Members that voluntarily elect to participate in the Affiliated Entity
Program in a uniform manner.

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

    No written comments were either solicited or 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.\8\ 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: (i) Necessary or appropriate in the public interest; (ii)
for the protection of investors; or (iii) 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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    \8\ 15 U.S.C. 78s(b)(3)(A)(ii).
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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 protected]. Please include
File Number SR-MRX-2021-12 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-MRX-2021-12. 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-MRX-2021-12 and should be
submitted on or before January 10, 2022.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\9\
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    \9\ 17 CFR 200.30-3(a)(12).
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J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2021-27428 Filed 12-17-21; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 86, Number 57 (Friday, March 26, 2021)]
[Notices]
[Pages 16205-16206]
[FR Doc No: 2021-06304]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 11478-021]

Green Mountain Power; Notice of Application Accepted for Filing
and Soliciting Comments, Motions To Intervene, and Protests

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:
    a. Application Type: Amend license to temporarily lower reservoir
and replace outlet conduit.
    b. Project No: 11478-021.
    c. Date Filed: March 18, 2021.
    d. Applicant: Green Mountain Power.
    e. Name of Project: Silver Lake.
    f. Location: Sucker Brook, Addison County, Vermont.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791a-825r.
    h. Applicant Contact: John Greenan, Green Mountain Power
Corporation, 2152 Post Road, Rutland, VT 05701,<PHONE_NUMBER>.
    i. FERC Contact: David Rudisail,<PHONE_NUMBER>,
<EMAIL_ADDRESS>    j. Deadline for filing comments, motions to intervene, and
protests: April 6, 2021.
    The Commission strongly encourages electronic filing. Please file
comments, motions to intervene, and protests using the Commission's
eFiling system at http://www.ferc.gov/docs-filing/efiling.asp.
Commenters can submit brief comments up to 6,000 characters, without
prior registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact
information at the end of your comments. For assistance, please contact
FERC Online Support at<EMAIL_ADDRESS>(866) 208-3676 (toll
free), or<PHONE_NUMBER> (TTY). In lieu of electronic filing, you may
submit a paper copy. Submissions sent via the U.S. Postal Service must
be addressed to: Kimberly D. Bose, Secretary, Federal Energy Regulatory
Commission, 888 First Street NE, Room 1A, Washington, DC 20426.
Submissions sent via any other carrier must be addressed to: Kimberly
D. Bose, Secretary, Federal Energy Regulatory Commission, 12225 Wilkins
Avenue, Rockville, Maryland 20852. The first page of any filing should
include the docket number P-11478-021. Comments emailed to Commission
staff are not considered part of the Commission record.
    The Commission's Rules of Practice and Procedure require all
intervenors filing documents with the Commission to serve a copy of
that document on each person whose name appears on the official service
list for the project. Further, if an intervenor files comments or
documents with the Commission relating to the merits of an issue that
may affect the responsibilities of a particular resource agency, they
must also serve a copy of the document on that resource agency.

    k. Green Mountain Power proposes to temporarily lower the Sugar
Hill Reservoir approximately 27.5 feet from the current elevation to
allow replacement of the outlet conduit.
    l. Locations of the Application: This filing may be viewed on the
Commission's website at http://www.ferc.gov using the ``eLibrary''
link. Enter the docket number excluding the last three digits in the
docket number field to access the document. You may also register
online at http://www.ferc.gov/docs-filing/esubscription.asp to be
notified via email of new filings and issuances related to this or
other pending projects. For assistance, call 1-866-208-3676 or email
<EMAIL_ADDRESS>for TTY, call<PHONE_NUMBER>. Agencies may
obtain copies of the application directly from the applicant.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Protests, or Motions to Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214, respectively. In determining the appropriate action to take, the
Commission will consider all protests or other comments filed, but only
those who file a motion to intervene in accordance with the
Commission's Rules may become a party to the proceeding. Any comments,
protests, or motions to intervene must be received on or before the
specified comment date for the particular application.
    o. Filing and Service of Documents: Any filing must (1) bear in all
capital letters the title ``COMMENTS'', ``PROTEST'', or ``MOTION TO
INTERVENE'' as applicable; (2) set forth in the heading the name of the
applicant and the project number of the application to which the filing
responds; (3) furnish the name, address, and telephone number of the
person commenting, protesting or intervening; and (4) otherwise comply
with the requirements of 18 CFR 385.2001 through 385.2005. All
comments, motions to intervene, or protests must set forth their
evidentiary basis. Any filing made by an intervenor must be accompanied
by proof of service on all persons listed in the service list prepared
by the Commission in this proceeding, in accordance with 18 CFR
385.2010.

    Dated: March 22, 2021.
Kimberly D. Bose,
Secretary.
[FR Doc. 2021-06304 Filed 3-25-21; 8:45 am]
BILLING CODE 6717-01-P


Table 3c. Freshwater and Saltwater Final Acute Value ( FAV) and Criteria Calculations Calculated Freshwater FAV based on 4 lowest values: Total Number of GMAVs in Data Set = 27 Rank GMAV lnGMAV ( lnGMAV) 2 P = R/( n+ 1) SQRT( P)

4 8.5666 2.148 4.613 0.14286 0.3780 3 5.7536 1.750 3.062 0.10714 0.3273 2 5.7472 1.749 3.058 0.07143 0.2673 1 3.5579 1.269 1.611 0.03571 0.1890 Sum: 6.916 12.34 0.3571 1.1615 S = 4.419 L = 0.4456 A = 1.434 Calculated FAV = 4.194590 Calculated CMC = 2.097 Dissolved Copper Criterion Maximum Concentration ( CMC) = 2.1 µ g/ L ( for example normalization chemistry see Table 1a, footnote f) Criteria Lethal Accumulation ( LA50) based on example normalization chemistry = 0.0412 nmol/ g wet wt Criterion Continuous Concentration ( CCC) = 4.19459/ 3.23 = 1.3 µ g/ L ( for example normalization chemistry see Table 1a, footnote f)

Calculated Saltwater FAV based on 4 lowest values: Total Number of GMAVs in Data Set = 44 Rank GMAV lnGMAV ( lnGMAV) 2 P = R/( n+ 1) SQRT( P)

4 12.81 2.550 6.503 0.08889 0.2981 3 12.66 2.538 6.444 0.06667 0.2582 2 12.60 2.534 6.421 0.04444 0.2108 1 11.53 2.445 5.979 0.02222 0.1491 Sum: 10.068 25.35 0.2222 0.9162 S = 0.752 L = 2.3447 A = 2.513 Calculated FAV = 12.340 Lowered FAV = 6.188 Calculated CMC = 6.170 Calculated CMC = 3.094 Dissolved Copper Final Acute Value ( FAV) = 6.188 µ g/ L ( lowered from 12.30 to protect Mytilus sp. ) Dissolved Copper Criterion Maximum Concentration ( CMC) = 6.188/ 2 = 3.1 µ g/ L Criterion Continuous Concentration ( CCC) = 6.188/ 3.23 = 1.9 µ g/ L S = Scale parameter or slope L = Location parameter or intercept P = Cumulative probability A = lnFAV 49


[Federal Register Volume 83, Number 96 (Thursday, May 17, 2018)]
[Rules and Regulations]
[Pages 22846-22848]
[FR Doc No: 2018-10563]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 878

[Docket No. FDA-2017-N-4919]

Medical Devices; Exemption From Premarket Notification: Class II
Devices; Surgical Apparel

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is publishing
this final order to exempt certain surgical apparel from premarket
notification requirements, subject to conditions and limitations. FDA
is limiting the exemption to single-use, disposable respiratory
protective devices (RPD) used in a healthcare setting and worn by
healthcare personnel during procedures to protect both the patient and
the healthcare personnel from the transfer of microorganisms, body
fluids, and particulate material. These devices, commonly referred to
as N95 filtering facepiece respirators (FFRs) and surgical N95
respirators (herein collectively referred to as N95s) are currently
regulated by FDA under product code MSH. This exemption will decrease
regulatory burden on the medical device industry and will eliminate
private costs and expenditures required to comply with certain Federal
regulations. All other class II devices classified under FDA's surgical
apparel classification regulation continue to be subject to premarket
notification requirements. FDA is also amending the codified language
for the surgical apparel devices classification regulation to reflect
this final determination.

DATES: This order is effective May 17, 2018.

FOR FURTHER INFORMATION CONTACT: Aftin Ross, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave, Bldg. 66, Rm. 5402, Silver Spring, MD 20993,<PHONE_NUMBER>, email:
[email protected].

SUPPLEMENTARY INFORMATION:

I. Statutory Background

    Section 510(k) of the Federal Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 360(k)) and the implementing regulations, 21 CFR part
807, subpart E, require persons who intend to market a new device to
submit and obtain clearance of a premarket notification (510(k))
containing information that allows FDA to determine whether the new
device is ``substantially equivalent'' within the meaning of section
513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a legally marketed device
that does not require premarket approval.
    The 21st Century Cures Act (Pub. L. 114-255) (Cures Act) was signed
into law on December 13, 2016. Section 3054 of the Cures Act amended
section 510(m) of the FD&C Act. As amended, section 510(m)(2) of the
FD&C Act provides that, 1 calendar day after the date of publication of
the final list under paragraph (1)(B), FDA may exempt a class II device
from the requirement to submit a report under section 510(k) of the
FD&C Act upon its own initiative or a petition of an interested person,
if FDA determines that a report under section 510(k) is not necessary
to assure the safety and effectiveness of the device. To do so, FDA
must publish in the Federal Register notice of its intent to exempt the
device, or of the petition, and provide a 60-calendar day period for
public comment. Within 120 days after the issuance of the notice, FDA
shall publish an order in the Federal Register that sets forth its
final determination regarding the exemption of the device that was the
subject of the notice.

II. Factors FDA May Consider for Exemption

    There are a number of factors FDA may consider to determine whether
a 510(k) is necessary to provide reasonable assurance of the safety and
effectiveness of a class II device. These factors are discussed in the
January 21, 1998, Federal Register notice (63 FR 3142) and subsequently
in the guidance the Agency issued on February 19, 1998, entitled
``Procedures for Class II Device Exemptions From Premarket
Notification; Guidance for Industry and CDRH Staff'' (``Class II 510(k)
Exemption Guidance'') (Ref. 1). Accordingly, FDA generally considers
the following factors to determine whether a 510(k) is necessary for
class II devices: (1) The device does not have a significant history of
false or misleading claims or of risks associated with inherent
characteristics of the device; (2) characteristics of the device
necessary for its safe and effective performance are well established;
(3)

changes in the device that could affect safety and effectiveness will
either: (a) Be readily detectable by users by visual examination or
other means such as routine testing, before causing harm, or (b) not
materially increase the risk of injury, incorrect diagnosis, or
ineffective treatment; and (4) any changes to the device would not be
likely to result in a change in the device's classification. FDA may
also consider that, even when exempting devices, these devices would
still be subject to the limitations on exemptions.

III. Device Description

    FDA, upon its own initiative, is exempting N95 filtering facepiece
respirators (FFRs) and surgical N95 respirators (herein collectively
referred to as N95s) from 510(k), subject to the conditions and
limitations described in this section. FDA considers N95s to be a
subset of ``surgical apparel'' intended to be worn by healthcare
personnel to protect both the patient and the healthcare personnel from
transfer of microorganisms, body fluids, and particulate material. As a
result, these devices fall under the generic name ``surgical apparel''
and are classified in Sec.  878.4040(b)(1) (21 CFR 878.4040(b)(1)). In
the Federal Register of June 24, 1988 (53 FR 23856), FDA issued a final
rule classifying surgical apparel into class II (special controls). We
are now exempting a subset of surgical apparel devices currently
regulated under product code MSH from 510(k) review. FDA has assessed
the need for 510(k) against the criteria laid out in the Class II
510(k) Exemption Guidance and determined that these devices no longer
require a 510(k) to provide reasonable assurance of safety and
effectiveness. However, this exemption is limited and FDA's
determination only applies to those N95s under the conditions listed
below.
    FDA has a Memorandum of Understanding (MOU) with the Centers for
Disease Control and Prevention (CDC), acting through its National
Institute for Occupational Safety and Health (NIOSH), regarding
oversight of N95s (Ref. 2). This agreement outlines the structure
through which both Agencies will regulate N95s exempt from 510(k). The
MOU between NIOSH and FDA is now effective as part of this final order.
    Although FDA and CDC share a common public health mission, the
Agencies have different statutory authorities and the distinct
terminology could lead to confusion among stakeholders. In order to
clearly identify the devices that are subject to this document, as well
as the corresponding MOU, the following definitions are provided for
the devices that are now exempt.
    The N95 FFR is a single-use disposable, half-mask respiratory
protective device that covers the user's airway (nose and mouth) and
offers protection from particulate materials at an N95 filtration
efficiency level per 42 CFR 84.181. Such an N95 FFR used in a
healthcare setting is a class II device, regulated by FDA under Sec.
878.4040.
    The surgical N95 respirator is a single-use, disposable respiratory
protective device used in a healthcare setting that is worn by HCP
during procedures to protect both the patient and HCP from the transfer
of microorganisms, body fluids, and particulate material at an N95
filtration efficiency level per 42 CFR 84.181. The surgical N95
respirator is also a class II device, regulated by FDA under Sec.
878.4040.
    In the Federal Register of November 30, 2017 (82 FR 56763), FDA
published a proposed order announcing its intent to exempt N95s from
premarket notification [510(k)] requirements, subject to certain
conditions and limitations, and provided opportunity for interested
persons to submit comments by January 30, 2018. After reviewing the
comments received (summarized in section IV), FDA is now providing its
final determination for N95s by exempting this type of device from
510(k) requirements, subject to certain conditions and limitations as
identified in this final order. FDA is also amending the codified
language for the surgical apparel devices classification regulation to
reflect this final determination. Persons with pending 510(k)
submissions for devices that are now exempt from 510(k), subject to the
conditions and limitations, should withdraw their submissions.

IV. Comments on the Proposed Exemption and FDA's Response

    In response to the November 2017 proposed order announcing FDA's
intent to exempt N95s from 510(k) requirements, FDA received
submissions from four commenters--two from regulated industry, one from
an industry association, and one from a consumer. Three commenters
supported the implementation of the MOU with the CDC, acting through
NIOSH, regarding oversight of N95s and exemption from 510(k) for this
device type. FDA agrees with the three commenters that the exemption
from 510(k) requirements will streamline the oversight of N95s without
compromising the public health.
    One commenter requested that these devices still be subject to
510(k) requirements to ensure safety of people using the disposable
respiratory protective devices. Further, the commenter indicated that
FDA's proposal should not be finalized because the sterility of these
devices can greatly affect those working in the health field and
patients being treated, and if these devices are not properly inspected
or regulated, diseases could spread more easily from person to person.
The commenter noted that because these devices will be used by surgical
staff, it is even more important that the devices be inspected because
surgery can involve open wounds or open body cavities, making it easier
to spread disease or bodily fluids.
    FDA notes in response to this commenter that N95s subject to this
exemption from 510(k) are not provided sterile to the user. While FDA
has exempted these devices from 510(k), the scientific evidence
necessary to legally market N95s within this exemption has not changed.
The majority of this testing has traditionally been reviewed by NIOSH.
The conditions and limitations of exemption that FDA has identified in
section V of this final order and Sec.  878.4040(b)(1) will provide
reasonable assurance of safety and effectiveness for N95s. Unless an
N95 meets the mutually agreed upon threshold evaluation criteria and
approval criteria and has NIOSH approval, the device would still be
subject to 510(k) review. Accordingly, FDA did not modify the exemption
or conditions and limitations of exemption proposed for N95s in
response to this comment.

V. Conditions and Limitations of Exemption

    As described in the MOU, the following conditions must be met for
N95s to be 510(k) exempt: (1) application submitted to NIOSH is
determined not to exceed the CDC's and FDA's mutually agreed upon
threshold evaluation criteria and (2) such applicants must have met
approval criteria and have NIOSH approval. N95s with applications that
meet the mutually agreed upon threshold evaluation criteria and
approval criteria and remain approved by NIOSH are exempt from FDA's
510(k) requirements. Unless an N95 meets the mutually agreed upon
threshold evaluation criteria and approval criteria and has NIOSH
approval, the device is subject to 510(k) review; this includes devices
with applications pending NIOSH review, as well as devices with no
submitted applications. The threshold evaluation criteria are

codified into the conditions and limitations of exemption described in
Sec.  878.4040(b)(1).
    N95s are the only devices included within the scope of the MOU. As
such, this exemption only applies to devices currently regulated by FDA
under product code MSH. This exemption does not affect any other subset
of surgical apparel classified under Sec.  878.4040. In addition to
being subject to the general limitations to the exemptions found in 21
CFR 878.9 and the conditions of exemption identified in this final
order, these devices will also remain subject to current good
manufacturing practices and other general controls under the FD&C Act.
An exemption from the requirement of 510(k) does not mean that the
device is exempt from any other statutory or regulatory requirements,
unless such exemption is explicitly provided by order or regulation.
    This exemption will decrease regulatory burdens on the medical
device industry and will eliminate private costs and expenditures
required to comply with Federal regulations. Specifically, regulated
industry will no longer have to invest time and resources in 510(k)s,
including preparation of documents and data for submission to FDA,
payment of user fees associated with 510(k) submissions, and responding
to questions and requests for additional information from FDA during
510(k) review for devices in this exempted device type, subject to the
conditions and limitations of the exemption.

VI. Paperwork Reduction Act of 1995

    This order refers to previously 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 21 CFR part 807, subpart, E have been approved under
OMB control number 0910-0120.

VII. References

    The following references are on display in the Dockets Management
Staff (see ADDRESSES) and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also
available electronically at https://www.regulations.gov. FDA has
verified the website addresses, as of the date this document publishes
in the Federal Register, but websites are subject to change over time.

    1. FDA Guidance, ``Procedures for Class II Device Exemptions
from Premarket Notification, Guidance for Industry and CDRH Staff,''
February 19, 1998, available at https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM080199.pdf.
    2. ``Memorandum of Understanding Between the Food and Drug
Administration, Center for Devices and Radiological Health, and the
Centers for Disease Control and Prevention, National Institute for
Occupational Safety and Health, National Personal Protective
Technology Laboratory,'' available at https://www.fda.gov/AboutFDA/PartnershipsCollaborations/MemorandaofUnderstandingMOUs/DomesticMOUs/.

List of Subjects in 21 CFR Part 878

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 321 et seq., as amended) and under authority delegated to the
Commissioner of Food and Drugs, 21 CFR part 878 is amended as follows:

PART 878--GENERAL AND PLASTIC SURGERY DEVICES

0
1. The authority citation for part 878 continues to read as follows:

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

0
2. In Sec.  878.4040, paragraph (b)(1) is revised to read as follows:

Sec.  878.4040  Surgical apparel.

* * * * *
    (b) Classification. (1) Class II (special controls) for surgical
gowns and surgical masks. A surgical N95 respirator or N95 filtering
facepiece respirator is not exempt if it is intended to prevent
specific diseases or infections, or it is labeled or otherwise
represented as filtering surgical smoke or plumes, filtering specific
amounts of viruses or bacteria, reducing the amount of and/or killing
viruses, bacteria, or fungi, or affecting allergenicity, or it contains
coating technologies unrelated to filtration (e.g., to reduce and or
kill microorganisms). Surgical N95 respirators and N95 filtering
facepiece respirators are exempt from the premarket notification
procedures in subpart E of part 807 of this chapter subject to Sec.
878.9, and the following conditions for exemption:
    (i) The user contacting components of the device must be
demonstrated to be biocompatible.
    (ii) Analysis and nonclinical testing must:
    (A) Characterize flammability and be demonstrated to be appropriate
for the intended environment of use; and
    (B) Demonstrate the ability of the device to resist penetration by
fluids, such as blood and body fluids, at a velocity consistent with
the intended use of the device.
    (iii) NIOSH approved under its regulation.
* * * * *

    Dated: May 14, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-10563 Filed 5-16-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: May 21, 2010 (Volume 75, Number 98)]
[Rules and Regulations]
[Page 28469-28471]
[DOCID:fr21my10-3]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2010-0491; Directorate Identifier 2009-SW-64-AD;
Amendment 39-16293; AD 2010-10-14]
RIN 2120-AA64

Airworthiness Directives; Eurocopter France Model AS332L2
Helicopters

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

ACTION: Final rule; request for comments.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for
Eurocopter France (Eurocopter) Model AS332L2 helicopters. This AD
results from a mandatory continuing airworthiness information (MCAI) AD
issued by the European Aviation Safety Agency (EASA), which is the
Technical Agent for the Member States of the European Community. The
MCAI AD states that the AD was issued after the discovery of broken
swashplate bearing attaching screw heads. Failure of these screw heads
could lead to the loss of the coupling between the non-rotating and the
rotating swashplate. This AD is intended to prevent loss of power to
the rotating swashplate and subsequent loss of control of the
helicopter.

DATES: This AD becomes effective on June 7, 2010.
    The Director of the Federal Register approved the incorporation by
reference of Eurocopter Alert Service Bulletin No. 62.00.66, dated
September 13, 2006, as of June 7, 2010.
    We must receive comments on this AD by July 20, 2010.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://
www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
    You may get the service information identified in this AD from
American Eurocopter Corporation, 2701 Forum Drive, Grand Prairie, TX
75053-4005, telephone<PHONE_NUMBER>, fax<PHONE_NUMBER>, or at http://
www.eurocopter.com.
    Examining the AD Docket: You may examine the AD docket on the
Internet at http://www.regulations.gov, or in person at the Docket
Operations office between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The AD docket contains this AD, the economic
evaluation, any comments received, and other information. The street
address for the Docket Operations office (telephone<PHONE_NUMBER>) is
in the ADDRESSES section. Comments will be available in the AD docket
shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Gary Roach, Aviation Safety Engineer,
FAA, Rotorcraft Directorate, Regulations and Guidance Group, Fort
Worth, Texas 76193-0111, telephone<PHONE_NUMBER>, fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    The EASA, which is the technical agent for the Member States of the
European Community, has issued EASA AD No. 2006-0339, dated November 9,
2006, to correct an unsafe condition for the specified helicopters. The
MCAI AD was issued after the discovery of broken swashplate bearing
attaching screw heads. Failure of these screw heads could lead to the
loss of the coupling between the non-rotating and the rotating
swashplate. This AD is intended to prevent loss of power to the
rotating swashplate and subsequent loss of control of the helicopter.
    You may obtain further information by examining the MCAI AD in the
AD docket.

Related Service Information

    Eurocopter has issued Alert Service Bulletin No. 62.00.66, dated
September 13, 2006. The actions described in the MCAI AD are intended
to correct the same unsafe condition as that identified in the service
information.

FAA's Evaluation and Unsafe Condition Determination

    This helicopter has been approved by the aviation authority of
France and is approved for operation in the United States. Pursuant to
our bilateral agreement with France, EASA, their Technical Agent, has
notified us of the unsafe condition described in the MCAI AD. We are
issuing this AD because we evaluated all information provided by EASA
and determined the unsafe condition exists and is likely to exist or
develop on other helicopters of the same type design.
    There are no helicopters of this type currently registered in the
United States. However, this rule is necessary to ensure that the
described unsafe condition is addressed if any of these helicopters are
placed on the U.S. register in the future.

Differences Between This AD and the MCAI AD

     This AD does not require you to send the assembly to an
``approved repair center for investigation and reconditioning.''
     This AD uses ``hours time-in-service'' instead of ``flying
hours.''
     This AD does not apply to non-installed parts.
     This AD does not include an inspection for masts that were
inspected per a previous MCAI AD.

Costs of Compliance

    There are no costs of compliance since there are no helicopters of
this type design on the U.S. registry.

FAA's Determination of the Effective Date

    Since there are currently no domestic operators of these
helicopters, notice and opportunity for public comment before issuing
this AD are unnecessary, and this amendment can be made effective in
less than 30 days.

Comments Invited

    This AD is a final rule that involves requirements affecting flight
safety, and we did not precede it by notice and opportunity for public
comment. We invite you to send any written relevant data, views, or
arguments about this AD. Send your comments to an address listed under
the ADDRESSES section. Include ``Docket No. FAA-2010-0491; Directorate
Identifier 2009-SW-64-AD'' at the beginning of your comments. We
specifically invite comments on the overall regulatory, economic,
environmental, and energy aspects of this AD. We will consider all
comments received by the closing date and may amend this AD because of
those comments.
    We will post all comments we receive, without change, to http://
www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this AD.

Authority for This Rulemaking

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

products identified in this rulemaking action.

Regulatory Findings

    We determined that this AD will not have federalism implications
under Executive Order 13132. This AD will not have a substantial direct
effect on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.
    For the reasons discussed above, I certify this AD:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979); and
    3. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

0
Accordingly, under the authority delegated to me by the Administrator,
the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new AD:

2010-10-14 Eurocopter France: Amendment 39-16293. Docket No. FAA-
2010-0491; Directorate Identifier 2009-SW-64-AD.

Effective Date

    (a) This airworthiness directive (AD) becomes effective June 7,
2010.

Other Affected ADs

    (b) None.

Applicability

    (c) This AD applies to Model AS332L2 helicopters, with a main
rotor mast assembly (mast) that has not been modified per MOD
0743714, installed, certificated in any category.

    Note 1: MOD 0743714 includes replacing the plastic peel shim
with a stainless steel peel shim, installing improved swashplate
bearing attachment screws, and increasing the torque on those
screws.

Reason

    (d) The mandatory continued airworthiness information (MCAI) AD
was issued after the discovery of broken swashplate bearing
attaching screw heads. Failure of these screw heads could lead to
the loss of the coupling between the non-rotating and the rotating
swashplate. This AD is intended to prevent loss of power to the
rotating swashplate and subsequent loss of control of the
helicopter.

Actions and Compliance

    (e) For each mast that has less than 750 hours TIS since it was
installed on any helicopter or since its last overhaul, within 20
hours time-in-service (TIS), unless already done, and thereafter at
intervals not to exceed 25 hours TIS, and for each mast that has 750
or more hours TIS since it was installed on any helicopter or since
its last overhaul, within 25 hours TIS, unless already done, and
thereafter at intervals not to exceed 25 hours TIS:
    (1) Inspect for the presence of each mast swashplate bearing
attachment screw head by either using a mirror or by feeling for the
screw heads under the flange. Do the inspections by following the
Accomplishment Instructions, Operational Procedure, paragraphs
2.B.1. through 2.B.2. and Figure 1, of Eurocopter Alert Service
Bulletin (ASB) No. 62.00.66, dated September 13, 2006, except this
AD does not require you to send the assembly to an ``approved repair
center for investigation and reconditioning.''
    (2) If an attachment screw head is missing, before further
flight, replace the unairworthy mast with an airworthy mast.

    Note 2: If you have complied with ASB No. 62.00.66, dated
September 13, 2006, you have met the intent of this AD.

Differences Between the FAA AD and the MCAI AD

    (f) This AD differs from the MCAI AD as follows:
    (1) This AD does not require you to send the assembly to an
``approved repair center for investigation and reconditioning.''
    (2) This AD uses ``hours TIS'' instead of ``flying hours.''
    (3) This AD does not apply to non-installed parts.
    (4) This AD does not include an inspection for masts that were
inspected per a previous MCAI AD.

Other Information

    (g) Alternative Methods of Compliance (AMOCs): The Manager,
Safety Management Group, Rotorcraft Directorate, FAA, has the
authority to approve AMOCs for this AD, if requested, using the
procedures found in 14 CFR 39.19. Send AMOC request to DOT/FAA
Southwest Region, Gary Roach, ASW-111, Aviation Safety Engineer,
Rotorcraft Directorate, Regulations and Guidance Group, 2601 Meacham
Blvd., Fort Worth, Texas 76137, telephone<PHONE_NUMBER>, fax (817)
222-5961.

Related Information

    (h) Mandatory Continuing Airworthiness Information (MCAI)
Airworthiness Directive No. 2006-0339, dated November 9, 2006,
contains related information.

Joint Aircraft System/Component (JASC) Code

    (i) The JASC Code is 6230--Main Rotor Mast/Swashplate.

Material Incorporated by Reference

    (j) You must use the specified portions of Eurocopter Alert
Service Bulletin No. 62.00.66, dated September 13, 2006, to do the
actions required.
    (1) The Director of the Federal Register approved the
incorporation by reference of the service information under 5 U.S.C.
552(a) and 1 CFR part 51.
    (2) For service information identified in this AD, contact
American Eurocopter Corporation, 2701 Forum Drive, Grand Prairie,
Texas 75053-4005, telephone<PHONE_NUMBER>, fax<PHONE_NUMBER>.
    (3) You may review copies of the service information at the FAA,
Office of the Regional Counsel, Southwest Region, 2601 Meacham
Blvd., Room 663, Fort Worth, Texas, or at the National Archives and
Records Administration (NARA). For information on the availability
of this material at NARA, call<PHONE_NUMBER>, or go to: http://
www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Fort Worth, Texas, on May 4, 2010.
Mark R. Schilling,
Acting Manager, Rotorcraft Directorate, Aircraft Certification Service.
[FR Doc. 2010-11418 Filed 5-20-10; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 79, Number 174 (Tuesday, September 9, 2014)]
[Notices]
[Pages 53492-53494]
[FR Doc No: 2014-21357]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-72963; File No. SR-NYSEArca-2014-99]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Extend the
Operation of the NYSE Arca ETP Incentive Program, Currently Scheduled
To Expire on September 3, 2014, for an Additional Year

September 3, 2014.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby given
that, on August 28, 2014, NYSE Arca, Inc. (``Exchange'' or ``NYSE
Arca'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I and
II 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\ 15 U.S.C. 78a.
    \3\ 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 extend the operation of the NYSE Arca ETP
Incentive Program, currently scheduled to expire on September 3, 2014,
for an additional year. The text of the proposed rule change is
available on the Exchange's Web site at www.nyse.com, at the principal
office of the Exchange, 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 self-regulatory organization
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 those 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 parts of such statements.

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

1. Purpose
    The Exchange proposes to extend the operation of the NYSE Arca ETP
Incentive Program (``Incentive Program''),\4\ a one-year pilot program
for issuers of certain exchange-traded products (``ETPs'') listed on
the Exchange, for an additional year. The Incentive Program is
currently scheduled to expire on September 3, 2014. As proposed, the
pilot program would be set to end on September 4, 2015.
---------------------------------------------------------------------------

    \4\ See Rule 8.800 and Securities Exchange Act Release No. 34-
69706 (June 6, 2013), 78 FR 35340 (June 12, 2013) (SR-NYSEArca-2013-
34) (order establishing the Incentive Program).
---------------------------------------------------------------------------

    NYSE Arca established the Incentive Program to enhance the market
quality for ETPs by incentivizing Market Makers \5\ to take Lead Market
Maker (``LMM'') assignments in certain lower volume ETPs by offering an
alternative fee structure for such LMMs. The Incentive Program is
designed to improve the quality of market for lower-volume ETPs,
thereby incentivizing them to list on the Exchange. Moreover, the
Exchange believes that the Incentive Program, which is entirely
voluntary, encourages competition among markets for issuers' listings
and among Market Makers for LMM assignments.
---------------------------------------------------------------------------

    \5\ A Market Maker is an Equity Trading Permit Holder (``ETP
Holder'') that acts as a Market Maker pursuant to NYSE Arca Equities
Rule 7. See NYSE Arca Equities Rule 1.1(v). An ETP Holder is a sole
proprietorship, partnership, corporation, limited liability company,
or other organization in good standing that has been issued an
Equity Trading Permit. See NYSE Arca Equities Rule 1.1(n).
---------------------------------------------------------------------------

    This filing seeks to extend the current operation of the Incentive
Program for an additional year to allow the Commission, the Exchange,
LMMs, and issuers to further assess the impact of the Incentive Program
before making it available to other securities and implementing the
program on a permanent basis.\6\ During the initial one-year pilot
period, because no ETP issuers signed up for the Incentive Program, the
Exchange does not have any data to assess the impact of the Incentive
Program on ETP market quality or whether any provisions of the
Incentive Program should be modified.\7\

The Exchange believes that extending the pilot period for an additional
year will provide additional time for issuers to participate in the
Incentive Program so that the Commission, the Exchange, LMMs, and
issuers may assess the impact of the Incentive Program before making it
available to other securities or implementing it on a permanent
basis.\8\
---------------------------------------------------------------------------

    \6\ The Exchange notes that any proposed further continuance of
the Incentive Program or proposal to make the Inventive Program
permanent would require a rule filing with the Commission pursuant
to Section 19(b) of the Act and Rule 19b-4 thereunder.
    \7\ See Securities Exchange Act Release No. 34-69706 (June 6,
2013), 78 FR 35340 (June 12, 2013) (SR-NYSEArca-2013-34) (order
approving Rule 8.800 and specifying the requirement for the Exchange
to assess the impact of the Incentive Program).
    \8\ The Exchange notes that if the Incentive Program in its
current form continues to go unused, the Exchange will not seek an
additional extension of the pilot period.
---------------------------------------------------------------------------

    This filing is not otherwise intended to address any other issues
and does not propose any substantive changes to the Incentive Program.
The Exchange is not aware of any problems that ETP Holders or issuers
would have in complying with the proposed extension.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Act,\9\ in general, and furthers the
objectives of Sections 6(b)(5) of the Act,\10\ in particular, because
it is 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 facilitating
transactions in securities, to remove impediments to, and perfect the
mechanisms of, a free and open market and a national market system. The
Exchange believes that the proposed rule change would remove
impediments to and perfect the mechanism of a free and open market and
national market system because it provides a venue to enhance quote
competition, improve liquidity, support the quality of price discovery,
promote market transparency, and increase competition for listings and
trade executions while reducing spreads and transaction costs.
Moreover, requesting an extension of the Incentive Plan will permit
additional time for the Commission, the Exchange, LMMs, and issuers to
assess the impact of the Incentive Program before making it available
to other securities. Finally, the Exchange believes that it is subject
to significant competitive forces, as described below in the Exchange's
statement regarding the burden on competition. For these reasons, the
Exchange believes that the proposal is consistent with the Act.
---------------------------------------------------------------------------

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

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

    In accordance with Section 6(b)(8) of the Act,\11\ the Exchange
believes that the proposed rule change would not impose any burden on
competition that is not necessary or appropriate in furtherance of the
purposes of the Act. The Exchange believes that extending the operation
of the Incentive Program will enhance competition among liquidity
providers and thereby improve execution quality on the Exchange. The
Exchange will continue to monitor the efficacy of the program during
the proposed extended pilot period.
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78f(b)(8).
---------------------------------------------------------------------------

    Finally, the Exchange notes that it operates in a highly
competitive market in which issuers and market participants can readily
favor competing venues. In such an environment, the Exchange must
continually review and consider adjusting the services it offers and
the requirements it imposes in order to remain competitive with other
U.S. equity exchanges. Moreover, the competition for listings among the
exchanges is fierce. The Exchange notes that BATS Exchange, Inc.
(``BATS'') has already implemented a program similar to the Exchange's
proposed Incentive Program,\12\ and NASDAQ has received approval to do
so as well.\13\
---------------------------------------------------------------------------

    \12\ See Interpretation and Policy .02 of BATS Rule 11.8. See
also Securities Exchange Act Release Nos. 66307 (February 2, 2012),
77 FR 6608 (February 8, 2012) (SR-BATS-2011-051) and 66427 (February
21, 2012), 77 FR 11608 (February 27, 2012) (SR-BATS-2012-011).
    \13\ See Securities Exchange Act Release No. 69195 (March 20,
2013), 78 FR 18393 (March 26, 2013) (SR-NASDAQ-2012-137).
---------------------------------------------------------------------------

    For the reasons described above, the Exchange believes that the
proposed rule change reflects this competitive environment.

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

    No written comments were solicited or received with respect to the
proposed rule change.

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

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, if consistent with
the protection of investors and the public interest, the proposed rule
change has become effective pursuant to Section 19(b)(3)(A) of the Act
\14\ and Rule 19b-4(f)(6) thereunder.\15\
---------------------------------------------------------------------------

    \14\ 15 U.S.C. 78s(b)(3)(A).
    \15\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Exchange has satisfied this requirement.
---------------------------------------------------------------------------

    A proposed rule change filed under Rule 19b-4(f)(6) normally does
not become operative for 30 days after the date of filing. However,
Rule 19b-4(f)(6)(iii) permits the Commission to designate a shorter
time if such action is consistent with the protection of investors and
the public interest. The Exchange requests that the Commission waive
the 30-day operative delay to allow the Incentive Program to continue
without interruption after September 3, 2014, and therefore be
available should an issuer be interested in participating during
September 2014. The Commission believes that waiving the 30-day
operative delay is consistent with the protection of investors and the
public interest.\16\ As stated in the proposal, the Exchange seeks to
extend the current operation of the Incentive Program for an additional
year and does not propose any substantive changes to the Incentive
Program. The Exchange states that during the initial one-year pilot
period, no ETP issuers signed up for the Incentive Program, and
therefore, the Exchange has no data to assess the impact of the
Incentive Program on ETP market quality or whether any provisions of
the Incentive Program should be modified.\17\ The Exchange believes
that extending the pilot period for an additional year will provide
additional time for issuers to participate in the Incentive Program so
that the Commission, the Exchange, LMMs, and issuers may assess the
impact of the Incentive Program. The Commission notes that if the
Incentive Program in its current form continues to go unused, the
Exchange will not seek an additional extension of the pilot period.
Because the proposed change does not alter the substantive terms of the
Incentive Program and does not raise any novel or unique regulatory
issues, the

Commission designates the proposed rule change as operative upon
filing.
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    \16\ For purposes only of waiving the 30-day operative delay,
the Commission has also considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
    \17\ See supra note 6. The Commission notes that any proposed
modification of any provision of the Incentive Program would also
require a rule filing with the Commission pursuant to Section 19(b)
of the Act and Rule 19b-4 thereunder.
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    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.

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-NYSEArca-2014-99 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-NYSEArca-2014-99. 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 such filing will also 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-NYSEArca-2014-99 and should
be submitted on or before September 30, 2014.
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    \18\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\18\
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-21357 Filed 9-8-14; 8:45 am]
BILLING CODE 8011-01-P


The Alliance for Healthy Homes requested a meeting with EPA. EPA met with a representative of the Alliance for Healthy Homes on March 17, 2006 In attendance:

Jane Malone, Alliance for Healthy Homes Maria Doa, National Program Chemicals Division, Office of Pollution Prevention and Toxics, USEPA While the topics in the meeting ranged across a number of issues associated with the TSCA Lead Program, the discussion did include some aspects of the Lead Renovation, Repair, and Painting program proposed rule.

Prohibited practices Prohibited practices should not be allowed. The containment activities described in the proposed rule are not sufficient to contain the large amounts of dust generated by these practices. Thus, residents will still be exposed. In addition, workers who use these practices are exposed.

The use of electrostatic cleaning cloths as a proxy for clearance The electrostatic cleaning cloths are not a sufficient surrogate for clearance testing. They provide a false sense of certainty to consumers.

Worker training All workers should be trained, not only the renovators. The distinction EPA assumes between renovators and workers is a false distinction. The training course should be shorted but apply to workers.


[Federal Register Volume 85, Number 75 (Friday, April 17, 2020)]
[Notices]
[Pages 21499-21500]
[FR Doc No: 2020-08190]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Docket No. FAA-2020-0115]

Agency Information Collection Activities: Requests for Comments;
Clearance of a Renewed Approval of Information Collection: Aviation
Research Grants Program Correction

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comments.

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SUMMARY: In accordance with the Paperwork Reduction Act of 1995, the
Federal Aviation Administration (FAA) invites public comments about its
intention to request the Office of Management and Budget (OMB) approval
to renew an information collection. The information to be collected
will be used to and/or is necessary for the purpose of selecting,
evaluating, and determining eligibility of applicants for potential
grant award under the FAA Aviation Research Grants Program. Grants
awarded under this program are for the potential benefit of the long-
term growth of civil aviation and Commercial Space Transportation.

DATES: Written comments should be submitted by June 16, 2020.

ADDRESSES: Please send written comments:
    By Electronic Docket: www.regulations.gov (Enter docket number into
search field)
    By mail: Trina M. Bellamy, Grants Officer, William J. Hughes
Technical Center, Building 300, Acquisition & Grants Division, Atlantic
City International Airport, Atlantic City, NJ 08405

FOR FURTHER INFORMATION CONTACT: Trina M. Bellamy by email at
<EMAIL_ADDRESS>phone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including (a) Whether the proposed
collection of information is necessary for FAA's performance; (b) the
accuracy of the estimated burden; (c) ways for FAA to enhance the
quality, utility and clarity of the information collection; and (d)
ways that the burden could be minimized without reducing the quality of
the collected information. The agency will summarize and/or include
your comments in the request for OMB's clearance of this information
collection.
    OMB Control Number: 2120-0559.
    Title: Aviation Research Grants Program.
    Form Numbers: SF-272, 9550-5, SF-424, SF-3881, SF-269, SF-270.
    Type of Review: Renewal of an information collection.
    Background: The FAA Aviation Research Grant Program establishes
uniform policies and procedures for the award and administration of
research grants and cooperative agreements to colleges, universities,
not for profit research institutions for research that is of potential
benefit to the long-term growth of civil aviation and Commercial Space
Transportation. This program implements OMB Circular A-110, Public Law
101-508, Section 9205 and 9208 and Public Law 101-604, Section 107(d).
The information is collected through a solicitation that has been
published by the FAA. Prospective grantees respond to the solicitation
using a proposal format outlined in the solicitation in adherence to
applicable FAA directives, statutes, and OMB circulars.
    Respondents: 50.
    Frequency: On occasion.
    Estimated Average Burden per Response: 5 hours.
    Estimated Total Annual Burden: 5 hours per respondent.

    Issued in Atlantic City, NJ, on April 13, 2020.
Trina M. Bellamy,
Grants Officer,Acquisition & Grants Division/AAQ-600.
[FR Doc. 2020-08190 Filed 4-16-20; 8:45 am]
BILLING CODE 4910-13-P