[Federal Register: July 6, 2010 (Volume 75, Number 128)]
[Notices]
[Page 38857-38858]
[DOCID:fr06jy10-112]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-62392; File No. SR-NASDAQ-2010-077]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC;
Notice of Filing of Proposed Rule Change Relating to Pricing for Direct
Circuit Connections

June 28, 2010.
    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 June 21, 2010, The NASDAQ Stock Market LLC (the ``Exchange'' or
``NASDAQ'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by the Exchange. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
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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 the
Substance of the Proposed Rule Change

    NASDAQ is filing with the Securities and Exchange Commission
(``SEC'' or ``Commission'') a proposed rule change to establish pricing
for 10Gb direct circuit connections and codify pricing for 10Gb [sic]
direct circuit connections for customers who are not co-located in
NASDAQ's datacenter. The text of the proposed rule change is available
at http://nasdaq.cchwallstreet.com, at the Exchange'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 is proposing to establish fees for direct 10Gb circuit
connections, and codify fees for direct circuit connections capable of
supporting up to 1Gb, for customers who are not co-located at the
Exchange's datacenter. Currently, the Exchange already makes available
to co-located customers a 10Gb circuit connection and charges for each
a $1,000 initial installation charge as well as an ongoing monthly fee
of $5,000. The Exchange is establishing the same fees for non co-
located customers with a 10Gb circuit.\3\
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    \3\ NASDAQ provides an additional 1Gb copper connection option
to Nasdaq for co-located customers. Given the technological
constraints of copper connections over longer distances, NASDAQ does
not offer a copper connection option to users outside of its
datacenter.
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    The Exchange also already makes available to both co-located and
non co-located customers direct connections capable of supporting up to
1Gb, with per connection monthly fees of $500 for co-located customers
and $1,000 for non co-located customers. Monthly fees are higher for
non co-located customers because direct connections require NASDAQ to
provide cabinet space and middleware for those customers' third-party
vendors to connect into the datacenter and, ultimately, to the trading
system. Finally, for non co-located customers the Exchange charges an
optional installation fee of $925 if the customer chooses to use an on-
site router.
2. Statutory Basis
    NASDAQ believes that the proposed rule change is consistent with
the provisions of Section 6 of the Act,\4\ in general, and with
Sections 6(b)(5) of the Act,\5\ in particular, in that the proposal 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 regulating, clearing,
settling, processing information with respect to, and facilitating
transactions in securities, to remove impediments to and perfect the
mechanism of a free and open market and a national market system, and,
in general, to protect investors and the public interest. In
particular, the proposal will provide greater

transparency into the connectivity options available to market
participants.
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    \4\ 15 U.S.C. 78f.
    \5\ 15 U.S.C. 78f(b)(5).
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    The Exchange also believes that the proposed rule change is
consistent with the provisions of Section 6 of the Act,\6\ in general,
and with Section 6(b)(4) of the Act,\7\ 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 or system which the Exchange operates or controls. The filing
codifies and makes transparent the fees imposed for direct connections
to non co-located customers. These fees are uniform for all such
customers and are either comparable to fees charged to co-located
customers or vary due to different costs associated with providing
service to the two customer types.
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    \6\ 15 U.S.C. 78f.
    \7\ 15 U.S.C. 78f(b)(4).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    NASDAQ 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, as amended.

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

    Within 35 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:
    (A) By order approve such proposed rule change, or
    (B) institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change, as amended, 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 e-mail to<EMAIL_ADDRESS>Please include
File Number SR-NASDAQ-2010-077 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.
All submissions should refer to File Number SR-NASDAQ-2010-077. This
file number should be included on the subject line if e-mail 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 a.m. and 3 p.m. Copies of such filing also will be
available for inspection and copying at the principal office of the
Exchange. All comments received will be posted without change; the
Commission does not edit personal identifying information from
submissions. You should submit only information that you wish to make
available publicly. All submissions should refer to File Number SR-
NASDAQ-2010-077 and should be submitted on or before July 27, 2010.
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    \8\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\8\
Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-16289 Filed 7-2-10; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 88, Number 73 (Monday, April 17, 2023)]
[Notices]
[Pages 23419-23420]
[FR Doc No: 2023-08070]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OGC-2023-0212; FRL-10878-01-OGC]

Proposed Settlement Agreement, Clean Air Act Citizen Suit

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of proposed settlement agreement; request for public
comment.

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SUMMARY: In accordance with the Clean Air Act, as amended (CAA), notice
is given of a proposed settlement agreement in Center for Biological
Diversity v. Environmental Protection Agency, Case No. 22-1164 (D.C.
Cir.). On July 20, 2022, the Center for Biological Diversity (CBD)
filed a petition for review in the United States District Court for the
District of Columbia alleging that the Environmental Protection Agency
(EPA or the Agency) failed to comply with the consultation requirements
of the Endangered Species Act (ESA), the CAA, and the Administrative
Procedures Act (APA) in promulgating the Renewable Fuel Standard (RFS)
Program: RFS Annual Rules, (July 1, 2022) (``2020-2022 RFS Annual
Rule''). With the proposed settlement agreement, EPA would commit to
complete its ESA consultation for the subsequent RFS rule proposed on
December 30, 2022, the Renewable Fuel Standard (RFS) Program: Standards
for 2023-2025 and Other Changes, (December 30, 2022) (``2023-2025 RFS
Set Rule''), and CBD would agree to dismiss its challenge to the 2020-
2022 RFS Annual Rule.

DATES: Written comments on the proposed settlement agreement must be
received by May 17, 2023.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OGC-2023-0212, online at https://www.regulations.gov (EPA's preferred
method). Follow the online instructions for submitting comments.
    Instructions: All submissions received must include the Docket ID
number for this action. Comments received may be posted without change
to https://www.regulations.gov/, including any personal information
provided. For detailed instructions on sending comments and additional
information on the rulemaking process, see the ``Additional Information
about Commenting on the Proposed Settlement Agreement'' heading under
the SUPPLEMENTARY INFORMATION section of this document.

FOR FURTHER INFORMATION CONTACT: Meredith G. Miller, Air and Radiation
Law Office, Office of General Counsel, U.S. Environmental Protection
Agency; telephone<PHONE_NUMBER>; email address
[email protected].

SUPPLEMENTARY INFORMATION:

I. Obtaining a Copy of the Proposed Settlement Agreement

    The official public docket for this action (identified by Docket ID
No. EPA-HQ-OGC-2023-0212) contains a copy of the proposed settlement
agreement. The official public docket is available for public viewing
at the Office of Environmental Information (OEI) Docket in the EPA
Docket Center, EPA West, Room 3334, 1301 Constitution Ave. NW,
Washington, DC. The EPA Docket Center Public Reading Room is open from
8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the OEI Docket is (202) 566-
1752.
    The electronic version of the public docket for this action
contains a copy of the proposed settlement agreement, and is available
through https://www.regulations.gov. You may use https://www.regulations.gov to submit or view public comments, access the index
listing of the contents of the official public docket, and access those
documents in the public docket that are available electronically. Once
in the system, key in the appropriate docket identification number then
select ``search.''

II. Additional Information About the Proposed Settlement Agreement

    The RFS program began in 2006 pursuant to the requirements of the
Energy Policy Act of 2005 (EPAct) that were codified in CAA section
211(o). The statutory requirements were subsequently amended by the
Energy Independence and Security Act of 2007 (EISA). The RFS statute
sets forth annual, nationally applicable volume targets for biomass-
based diesel through 2012, and for the other three categories of
renewable fuel--total renewable fuel, advanced biofuel, and cellulosic
biofuel--through 2022. See 42 U.S.C 7545(o)(2)(B)(i). For calendar
years after which the statute provides volume targets, the statute
directs EPA to determine the applicable volume targets in coordination
with the Secretary of Energy and the Secretary of Agriculture, based on
a review of the implementation of the RFS program for prior years and
an analysis of specific factors enumerated by 42 U.S.C.
7545(o)(2)(B)(ii) (e.g., impacts on the environment and energy
security, costs to consumers, etc.).

    On July 1, 2022, EPA published the RFS annual rules for 2020, 2021,
and 2022. Renewable Fuel Standard (RFS) Program: RFS Annual Rules, 87
FR 39600 (July 1, 2022) (``2020-2022 RFS Annual Rule''). On July 20,
2022, CBD filed a petition for review of the 2020-2022 RFS Annual Rule
challenging whether EPA complied with the consultation requirements of
ESA section 7(a)(2), 16 U.S.C. 1536(a)(2); the CAA, 42 U.S.C.
7545(o)(2)(B)(ii)(I); and the APA, 5 U.S.C. 706. On September 27, 2022,
CBD filed a motion for summary vacatur of the 2020-2022 RFS Annual
Rule. Center for Biological Diversity v. Environmental Protection
Agency, Case No. 22-1164 (D.C. Cir.), Doc. 1966328.
    Under the proposed settlement agreement, EPA would commit to
complete its ESA section 7(a) consultation for the RFS rule subsequent
to the 2020-2022 RFS Annual Rule that EPA proposed on December 30,
2023. Renewable Fuel Standard (RFS) Program: Standards for 2023-2025
and Other Changes, 87 FR 80582 (December 30, 2022) (``2023-2025 RFS Set
Rule''). If either the Fish and Wildlife Service or the National Marine
Fisheries Service issues a biological opinion in connection with this
ESA consultation, EPA would also agree to issue a determination
addressing any conservation recommendations, terms and conditions of
any incidental take statement, and/or reasonable and prudent
alternatives within the time frames set forth in that biological
opinion. CBD would agree to dismiss with prejudice its challenge to the
2020-2022 RFS Annual Rule within five days of receiving notice from EPA
that it has terminated the ESA section 7(a) consultation for the 2023-
2025 RFS Set Rule.
    The proposed Settlement Agreement also includes standard language
regarding resolution of costs and attorneys' fees, stipulation of
extensions, lapses in appropriations, disputes in implementation,
preservation of Agency discretion, and the CAA section 113(g) process.
    In accordance with section 113(g) of the CAA, for a period of
thirty (30) days following the date of publication of this document,
the Agency will accept written comments relating to the proposed
settlement agreement. EPA or the Department of Justice may withdraw or
withhold consent to the proposed settlement agreement if the comments
disclose facts or considerations that indicate that such consent is
inappropriate, improper, inadequate, or inconsistent with the
requirements of the CAA.

III. Additional Information About Commenting on the Proposed Settlement
Agreement

    Submit your comments, identified by Docket ID No. EPA-HQ-OGC-2023-
0212, via https://www.regulations.gov. Once submitted, comments cannot
be edited or removed from this docket. EPA may publish any comment
received to its public docket. Do not submit to EPA's docket at https://www.regulations.gov any information you consider to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Multimedia submissions (audio, video, etc.) must
be accompanied by a written comment. The written comment is considered
the official comment and should include discussion of all points you
wish to make. EPA will generally not consider comments or comment
contents located outside of the primary submission (i.e., on the web,
cloud, or other file sharing system). For additional submission
methods, the full EPA public comment policy, information about CBI or
multimedia submissions, and general guidance on making effective
comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets. For additional information about submitting information
identified as CBI, please contact the person listed in the FOR FURTHER
INFORMATION CONTACT section of this document. Note that written
comments containing CBI and submitted by mail may be delayed and
deliveries or couriers will be received by scheduled appointment only.
    If you submit an electronic comment, EPA recommends that you
include your name, mailing address, and an email address or other
contact information in the body of your comment. This ensures that you
can be identified as the submitter of the comment and allows EPA to
contact you in case EPA cannot read your comment due to technical
difficulties or needs further information on the substance of your
comment. Any identifying or contact information provided in the body of
a comment will be included as part of the comment that is placed in the
official public docket and made available in EPA's electronic public
docket. If EPA cannot read your comment due to technical difficulties
and cannot contact you for clarification, EPA may not be able to
consider your comment.
    Use of the https://www.regulations.gov website to submit comments
to EPA electronically is EPA's preferred method for receiving comments.
The electronic public docket system is an ``anonymous access'' system,
which means EPA will not know your identity, email address, or other
contact information unless you provide it in the body of your comment.
    Please ensure that your comments are submitted within the specified
comment period. Comments received after the close of the comment period
will be marked ``late.'' EPA is not required to consider these late
comments.

Gautam Srinivasan,
Associate General Counsel.
[FR Doc. 2023-08070 Filed 4-14-23; 8:45 am]
BILLING CODE 6560-50-P


Johnd Bachmann 12/ 16/ 2003 04: 31 PM To: Amy_ L._ Farrell@ omb. eop. gov cc: Jeff Holmstead/ DC/ USEPA/ US@ EPA, Bill Wehrum/ DC/ USEPA/ US@ EPA, Stephanie Daigle/ DC/ USEPA/ US@ EPA, Don Zinger/ DC/ USEPA/ US@ EPA, Peter Tsirigotis/ RTP/ USEPA/ US@ EPA, Lisaa Jones/ DC/ USEPA/ US@ EPA, Sarah Dunham, Sam Napolitano, Lydia Wegman/ RTP/ USEPA/ US@ EPA Subject: Afternoon ' flip' of IAQR document This is a redline containing our revisions in response to your comments, in addition to some formatting/ editing revisions we are making. We included all comments received as of 1: 30, and many of the comments based on the latest sets of faxes in here. Also, the numbers of states affected and related language changes that may be needed are not included.

John Bachmann U. S. EPA C404 04 Research Triangle Park, NC27711 Voice 919 541 5359 Fax 919 541 2464 email Bachmann. JohnD@ epa. gov


[Federal Register Volume 81, Number 11 (Tuesday, January 19, 2016)]
[Notices]
[Pages 2928-2930]
[FR Doc No: 2016-00785]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-76880; File No. SR-Phlx-2015-118]

Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change To Amend
Section (a)(4) of Rule 640, Continuing Education for Registered Persons

January 12, 2016.
    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 30, 2015, NASDAQ OMX PHLX LLC (``Phlx'' 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, of which Items I and II 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 Section (a)(4) of Rule 640,
Continuing Education for Registered Persons, to provide for web-based
delivery of the Exchange's continuing education (``CE'') program. The
proposed rule change would phase out the current option of completing
the Regulatory Element in a test center, delete the current option for
in-house delivery of the Regulatory Element of the CE program and also
delete the existing text of Rule 640(a)(4), In-Firm Delivery of the
Regulatory Element. The Exchange's proposal, which is being filed for
immediate effectiveness and will be operative January 4, 2016, is
materially similar to a recent FINRA filing to amend FINRA Rule 1250,
which was recently approved by the Securities and Exchange Commission
(``Commission'').
    The text of the proposed rule change is available on the Exchange's
Web site at http://nasdaqomxphlx.cchwallstreet.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 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 CE requirements under Rule 640 consist of a Regulatory Element
\3\ and a Firm Element.\4\ The Regulatory Element applies to all
registered persons and consists of periodic computer-based training on
regulatory, compliance, ethical, and supervisory subjects and sales
practice standards, which must be completed within prescribed
timeframes.\5\ In addition, unless otherwise determined by the
Exchange, a registered person is required to re-take the Regulatory
Element of the program and satisfy the program's requirements in their
entirety in the event such person: (i) Becomes subject to any statutory
disqualification as defined in Section 3(a)(39) of the Securities
Exchange Act of 1934; (ii) becomes subject to suspension or to the
imposition of a fine of $5,000 or more for violation of any provision
of any securities law or regulation, or any agreement with or rule or
standard of conduct of any securities governmental agency, securities
self-regulatory organization, or as imposed by any such regulatory or
self-regulatory organization in connection with a disciplinary
proceeding; or (iii) is ordered as a sanction in a disciplinary action
to re-take the Regulatory Element by any securities governmental agency
or securities self-regulatory organization.
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    \3\ See Rule 640(a) (Regulatory Element).
    \4\ See Rule 640(b) (Firm Element).
    \5\ Pursuant to Rule 640, each registered person shall complete
the Regulatory Element of the continuing education program on the
occurrence of their second registration anniversary date(s), and
every three years thereafter or as otherwise prescribed by the
Exchange. On each occasion, the Regulatory Element must be completed
within 120 days after the person's registration anniversary date. A
person's initial registration date, also known as the ``base date,''
shall establish the cycle of anniversary dates for purposes of this
Rule.
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    Rule 640(a)(1) provides that the following Regulatory Elements
administered by FINRA shall be required: The S201 Supervisor Program
for registered principals and supervisors, the S501 Series 56
Proprietary Trader continuing education program for Series 56
registered persons, and the S101 General Program for Series 7 and all
other registered persons. Currently, the Regulatory Element may be
administered in a test center or in-firm subject to specified
procedures.\6\
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    \6\ Under current Rule 640(a)(4), In-Firm Delivery of the
Regulatory Element, members and member organizations are permitted
to administer the continuing education Regulatory Element program to
their registered persons by instituting an in-firm program
acceptable to the Exchange. Among others, the following procedures
are required in order to administer the Regulatory Element of the CE
program in-house: (1) The firm must designate a principal/officer-
in-charge to be responsible for the in-firm delivery of the
Regulatory Element; (2) the location of the delivery site must be
under the control of the firm; (3) the communication links and firm
delivery computer hardware must comply with standards defined by the
Exchange or its designated vendor; (4) the firm's written
supervisory procedures must contain the procedures implemented to
comply with requirements of in-firm delivery of the Regulatory
Element continuing education; (5) all sessions must be proctored by
an authorized person during the entire Regulatory Element continuing
education session and proctors must be present in the session room
or must be able to view the person(s) sitting for Regulatory Element
continuing education through a window or by video monitor; (6) all
appointments must be scheduled in advance using the procedures and
software specified by the Exchange to communicate with the
Exchange's system and designated vendor; and (7) a Letter of
Attestation for In-Firm Delivery of Regulatory Element CE must be
delivered.

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    The Firm Element consists of annual, member-developed and
administered training programs for covered registered persons,\7\ which
must be appropriate for the business of the member organization and, at
a minimum, must cover the following matters concerning securities
products, services and strategies offered by the member organization:
(a) General investment features and associated risk factors; (b)
suitability and sales practice considerations; and (c) applicable
regulatory requirements.
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    \7\ Under Rule 640(b) (Persons Subject to the Firm Element), a
``covered registered person'' means any registered person who has
direct contact with customers in the conduct of the member
organization's securities sales, trading or investment banking
activities, and to the immediate supervisors of such persons.
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    Currently, most registered persons complete the Regulatory Element
in a test center rather than in-firm. Given the advances in Web-based
technology, the Exchange believes that there is diminishing utility in
the test center and in-firm delivery methods. Moreover, according to
FINRA,\8\ registered persons have raised concerns with the test center
delivery method because of the travel involved, the limited time
currently available to complete a Regulatory Element session \9\ and
the use of rigorous security measures at test centers, which are
appropriate for taking qualification examinations but onerous for a CE
program.\10\ Also, according to FINRA, the test center is expensive to
operate.\11\
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    \8\ FINRA is currently responsible for the operation of the test
centers used for test center delivery method of the Regulatory
Element.
    \9\ The current session time is three-and-a-half hours.
    \10\ See Securities Exchange Act Release No. 75154 (June 11,
2015), 80 FR 34777 (June 17, 2015) (Notice of Filing of a Proposed
Rule Change To Provide a Web-Based Delivery Method for Completing
the Regulatory Element of the Continuing Education Requirements)
(SR-FINRA-2015-015).
    \11\ Id. at 34779.
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    In response to the issues noted above, FINRA engaged in extensive
outreach with the industry and completed a pilot of a Web-based
delivery system for administering the Regulatory Element.\12\ According
to FINRA, the proposed Web-based system performed well during the pilot
in terms of both performance and accessibility.\13\ FINRA also received
positive feedback from firms and the individual pilot participants.\14\
FINRA noted that among other things, pilot participants appreciated the
expanded time to focus on the provided learning materials without the
pressure of a timed session and the ability to resume or complete their
session from where they left off.\15\
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    \12\ Id.
    \13\ Id.
    \14\ Id.
    \15\ Id.
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Proposal
    Based on the recent amendments to FINRA Rule 1250,\16\ the Exchange
proposes to amend Rule 640(a)(4) to provide for a Web-based delivery
method for completing the Regulatory Element. Specifically, the
Exchange proposes to amend Rule 640(a)(4) to provide that the
continuing education Regulatory Element set forth in paragraph (a) of
Rule 640 will be administered through Web-based delivery or such other
technological manner and format as specified by the Exchange. Should
the Exchange determine to administer the Regulatory Element through a
delivery mechanism other than Web-based delivery, however, the Exchange
would notify the Commission and would need to file a further rule
change with the Commission.
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    \16\ See FINRA Rule 1250 (Continuing Education Requirements).
See also Securities Exchange Act Release No. 75581 (July 31, 2015)
80 FR 47018 (August 6, 2015) (Order Approving a Proposed Rule Change
to Provide a Web-based Delivery Method for Completing the Regulatory
Element of the Continuing Education Requirements) (SR-FINRA-2015-
015).
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    The first phase of the Web-based delivery system was launched
October 1, 2015 and includes the Regulatory Element of the S201
Supervisor Program for registered principals and supervisors. The
second phase of the Web-based delivery system will be launched January
4, 2016 and include the Regulatory Element of the S101 General Program
for Series 7 and all other registered persons, including, but not
limited to Securities Traders. The Exchange is proposing to phase out
test-center delivery by no later than six months after January 4, 2016.
Registered persons will continue to have the option of completing the
Regulatory Element in a test center, but they will be required to use
the Web-based system after the test-center delivery is phased out.\17\
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    \17\ The Exchange intends to amend its fee schedule to reduce
the cost for Regulatory Element CE from $100 to $55 if administered
by Web-delivery. Fees for completing the Regulatory Element at a
test center will remain $100.
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    Further, the Exchange is proposing to eliminate the current option
for in-firm delivery and is deleting the current text of Rule 640(a)(4)
relating to in-firm delivery of the Regulatory Element of the CE
programs. The proposed Web-based delivery method will provide
registered persons the flexibility to complete the Regulatory Element
at a location of their choosing, including their private residence, at
any time during their 120-day window for completion of the Regulatory
Element.\18\
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    \18\ Although the proposed rule change provides flexibility,
firms may choose to impose their own conditions based on their
supervisory and compliance needs. For instance, a firm that wishes
to have registered persons complete CE on the firm's premises can do
so by having the registered person access Web-based CE from a firm
device and location. Moreover, firms would have to update their
written policies and procedures regarding the Regulatory Element to
reflect the transition to Web-based CE and communicate the update to
registered persons.
---------------------------------------------------------------------------

    The Exchange notes that the Web-based format will include
safeguards to authenticate the identity of the CE candidate. For
instance, prior to commencing a Web-based session, the candidate will
be asked to provide a portion of their [sic] SSN (either first five or
last four digits) and their [sic] date of birth. This information will
only be used for matching data in FINRA's Web-CRD system. The Web CE
system will discard this information after the matching process.
Further, before commencing a Web-based session, each candidate will be
required to agree to the Rules of Conduct for Web-based delivery. Among
other things, the Rules of Conduct will require each candidate to
attest that he or she is in fact the person who is taking the Web-based
session. The Rules of Conduct will also require that each candidate
agree that the Regulatory Element content is intellectual property and
that the content cannot be copied or redistributed by any means. If the
Exchange discovers that a candidate has violated the Rules of Conduct,
the candidate will forfeit the results of the Web-based session and may
be subject to disciplinary action by the Exchange. Violation of the
Rules of Conduct will be considered conduct inconsistent with just and
equitable principles of trade, in violation of Rule 707, Conduct
Inconsistent with Just and Equitable Principles of Trade. The Exchange
is not proposing any changes to the Firm Element requirements under
Rule 640(b).
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act \19\ in general, and furthers the objectives of Section
6(b)(5) of the Act \20\

in particular, 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. Additionally, the
Exchange believes the proposed rule change is consistent with the
Section 6(b)(5) \21\ requirement that the rules of an exchange not be
designed to permit unfair discrimination between customers, issuers,
brokers, or dealers and Section 6(c)(3) \22\ of the Act, which
authorizes the Exchange to, among other things, prescribe standards of
financial responsibility or operational capability and standards of
training, experience and competence for its members and persons
associated with members.
---------------------------------------------------------------------------

    \19\ 15 U.S.C. 78f(b).
    \20\ 15 U.S.C. 78f(b)(5).
    \21\ 15 U.S.C. 78f(b)(5).
    \22\ 15 U.S.C. 78f(c)(3).
---------------------------------------------------------------------------

    In particular, the Exchange believes that the proposed rule change
will improve members' compliance efforts and will allow registered
persons to spend a greater amount of time on the review of CE materials
and potentially achieve better learning outcomes, which will in turn
enhance investor protection. Further, while the proposed rule change
will provide more flexibility to members and registered persons, it
will maintain the integrity of the Regulatory Element of the CE program
and the CE program in general.

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. The Exchange notes that the
proposed rule change is specifically intended to reduce the burden on
firms while preserving the integrity of the CE program. As described
above, the Web-based delivery method will provide registered persons
the flexibility to complete the Regulatory Element at any location that
they choose. Further, Web-based delivery is efficient and offers
significant cost savings over test-center and in-firm deliveries. With
respect to the authentication process for Web-based delivery, the CE
candidate's personal identifying information will be masked and will be
submitted to FINRA through a secure, encrypted, network. The personal
identifying information submitted via the Web-based system will be used
for authentication purposes only--the information will not be stored in
the Web-based system.

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

    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, it has become
effective pursuant to Section 19(b)(3)(A)(iii) of the Act \23\ and
subparagraph (f)(6) of Rule 19b-4 thereunder.\24\
---------------------------------------------------------------------------

    \23\ 15 U.S.C. 78s(b)(3)(a)(iii).
    \24\ 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.
---------------------------------------------------------------------------

    The Exchange has requested that the Commission waive the thirty-day
operative delay so that the proposal may become operative as of January
4, 2016. The Commission believes that waiving the thirty day delay is
consistent with the protection of investors and the public interest, as
it will enable the Exchange to have the new requirements in effect at
the same time as the other SROs. Therefore, the Commission hereby
waives the thirty-day operative delay and designates the proposal
operative as of January 4, 2016.\25\
---------------------------------------------------------------------------

    \25\ For purposes of waiving the 30-day operative delay, the
Commission has considered the proposed rule's impact on efficiency,
competition, and capital formation. See 15 U.S.C. 78c(f).
---------------------------------------------------------------------------

    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.

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-Phlx-2015-118 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-Phlx-2015-118. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml).
    Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for Web site viewing and printing in
the Commission's Public Reference Room, 100 F Street NE., Washington,
DC 20549, on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change; the Commission does not edit
personal identifying information from submissions. You should submit
only information that you wish to make available publicly.
    All submissions should refer to File Number SR-Phlx-2015-118 and
should be submitted on or before February 9, 2016.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\26\
---------------------------------------------------------------------------

    \26\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Robert W. Errett,
Deputy Secretary.
[FR Doc. 2016-00785 Filed 1-15-16; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register: July 29, 2009 (Volume 74, Number 144)]
[Proposed Rules]
[Page 37657-37658]
[DOCID:fr29jy09-39]

========================================================================
Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.

========================================================================

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2009-0657; Directorate Identifier 2009-NM-048-AD]
RIN 2120-AA64

Airworthiness Directives; Boeing Model 737-600, -700, -700C, -
800, -900, and -900ER Series Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for
certain Boeing Model 737-600, -700, -700C, -800, -900, and -900ER
series airplanes. This proposed AD would require replacing the engine
fuel shutoff valves for the left and right main tanks. This proposed AD
results from a report of a failed engine start, which was caused by an
internally fractured engine fuel shutoff valve. We are issuing this AD
to prevent the failure of the valve in the closed position, open
position, or partially open position, which could result in engine fuel
flow problems and possible uncontrolled fuel leak or fire.

DATES: We must receive comments on this proposed AD by September 14,
2009.

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.
    For service information identified in this proposed AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
P.O. Box 3707, MC 2H-65, Seattle, Washington 98124-2207; telephone 206-
544-5000, extension 1; fax<PHONE_NUMBER>; e-mail<EMAIL_ADDRESS>
Internet https://www.myboeingfleet.com. You may review copies of the
referenced service information at the FAA, Transport Airplane
Directorate, 1601 Lind Avenue, SW., Renton, Washington. For information
on the availability of this material at the FAA, call<PHONE_NUMBER> or
425-227-1152.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://
www.regulations.gov; or in person at the Docket Management Facility
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this proposed AD, the regulatory
evaluation, any comments received, and other information. The street
address for the Docket Office (telephone<PHONE_NUMBER>) is in the
ADDRESSES section. Comments will be available in the AD docket shortly
after receipt.

FOR FURTHER INFORMATION CONTACT: Samuel Spitzer, Aerospace Engineer,
Propulsion Branch, ANM-140S, FAA, Seattle Aircraft Certification
Office, 1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone
(425) 917-6510; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2009-0657;
Directorate Identifier 2009-NM-048-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed 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 proposed AD.

Discussion

    We have received a report of a failed engine start which was caused
by a fracture within the engine fuel shutoff valve, also known as the
spar valve. Examination of the valve showed a fracture between the
splined shaft and the disk portion of the valve. This condition results
in an inability to control the valve and could cause the spar valve to
position itself in the closed position, open position, or partially
open position. If the disc fails in the closed position, engine start
problems could result, as only fuel downstream of the valve is
available to the engine. If the disk fails in the open or partially
open position, the condition is latent, as full thrust can still be
achieved and the valve actuator functions and reports to the cockpit
normally. Additionally, if the valve fails while partially open, the
pressure drop across the valve could affect takeoff suction feed
performance if the fuel pumps fail. A failed open or partially open
valve cannot shut off fuel flow if there are fuel leakage conditions on
the engine side of the valve. This condition could result in engine
fuel flow problems and possible uncontrolled fuel leak or fire.

Relevant Service Information

    We have reviewed Boeing Service Bulletin 737-28-1272, dated October
31, 2008. The service bulletin describes procedures for replacing the
engine fuel spar valves for the left and right main tanks with valves
that have a stronger and more wear-resistant splined shaft on the disc
portion of the valve.
    The service bulletin refers to ITT Aerospace Controls Service
Bulletin 125334D-28-02, dated August 27, 2008, as an additional source
of service information for modifying the valve body assembly.

FAA's Determination and Requirements of This Proposed AD

    We are proposing this AD because we evaluated all relevant
information and determined the unsafe condition described previously is
likely to exist or develop in other products of the same type design.
This proposed AD would require accomplishing the actions

specified in the service information described previously.

Costs of Compliance

    We estimate that this proposed AD would affect 883 airplanes of
U.S. registry. We also estimate that it would take 26 work-hours per
product to comply with this proposed AD. The average labor rate is $80
per work-hour. Required parts would cost up to $8,496 per product.
Based on these figures, we estimate the cost of this proposed AD to the
U.S. operators to be up to $9,338,608, or $10,576 per product.

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 proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would 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 proposed
regulation:
    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.
    You can find our regulatory evaluation and the estimated costs of
compliance in the AD Docket.

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

    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]

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

Boeing: Docket No. FAA-2009-0657; Directorate Identifier 2009-NM-
048-AD.

Comments Due Date

    (a) We must receive comments by September 14, 2009.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to Boeing Model 737-600, -700, -700C, -800,
-900, and -900ER series airplanes, certificated in any category; as
identified in Boeing Service Bulletin 737-28-1272, dated October 31,
2008.

Subject

    (d) Air Transport Association (ATA) of America Code 28: Fuel.

Unsafe Condition

    (e) This AD requires replacing engine fuel shutoff valves for
the left and right main tanks. This AD results from a report of a
failed engine start, which was caused by an internally fractured
engine fuel shutoff valve. We are issuing this AD to prevent the
failure of the valve in the closed position, open position, or
partially open position, which could result in engine fuel flow
problems and possible uncontrolled fuel leak or fire.

Compliance

    (f) You are responsible for having the actions required by this
AD performed within the compliance times specified, unless the
actions have already been done.

Replacement of the Engine Fuel Spar Valve Body of the Left and Right
Wing Main Tanks

    (g) Within 60 months after the effective date of this AD:
Replace the engine fuel spar valve bodies of the left and right wing
main tanks in accordance with the Accomplishment Instructions of
Boeing Service Bulletin 737-28-1272, dated October 31, 2008.

    Note 1:  Boeing Service Bulletin 737-28-1272, dated October 31,
2008, refers to ITT Aerospace Controls Service Bulletin 125334D-28-
02, dated August 27, 2008, as an additional source of service
information for modifying the valve body assembly.

Parts Installation

    (h) As of the effective date of this AD, no person may install
any engine fuel shutoff valve with ITT Aerospace Controls part
number 125334D-1 (Boeing part number S343T003-40) on any airplane at
the spar valve location. A valve that has been modified in
accordance with Boeing Service Bulletin 737-28-1272, dated October
31, 2008, to the new ITT 125334D-2 part number (Boeing part number
S343T003-67) may be installed at the spar valve location.
    (i) As of the effective date of this AD, no valve with ITT
Aerospace Controls part number 125334D-1 (Boeing part number
S343T003-40) that has been removed from the spar location may be
reinstalled on any airplane in any location unless it has been
modified in accordance with Boeing Service Bulletin 737-28-1272,
dated October 31, 2008, to the new ITT 125334D-2 part number (Boeing
part number S343T003-67).

Alternative Methods of Compliance (AMOCs)

    (j)(1) The Manager, Seattle Aircraft Certification Office, FAA,
has the authority to approve AMOCs for this AD, if requested using
the procedures found in 14 CFR 39.19. Send information to ATTN:
Samuel Spitzer, Aerospace Engineer, Propulsion Branch, ANM-140S,
FAA, Seattle Aircraft Certification Office, 1601 Lind Avenue, SW.,
Renton, Washington 98057-3356; telephone<PHONE_NUMBER>; fax (425)
917-6590. Or, e-mail information to 9-ANM-Seattle-ACO-AMOC-
<EMAIL_ADDRESS>    (2) To request a different method of compliance or a different
compliance time for this AD, follow the procedures in 14 CFR 39.19.
Before using any approved AMOC on any airplane to which the AMOC
applies, notify your principal maintenance inspector (PMI) or
principal avionics inspector (PAI), as appropriate, or lacking a
principal inspector, your local Flight Standards District Office.
The AMOC approval letter must specifically reference this AD.

    Issued in Renton, Washington, on July 13, 2009.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. E9-17932 Filed 7-28-09; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register Volume 85, Number 84 (Thursday, April 30, 2020)]
[Rules and Regulations]
[Pages 23919-23920]
[FR Doc No: 2020-09169]

=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1

[Docket No. FDA-2020-D-1304]

Temporary Policy Regarding Accredited Third-Party Certification
Program Onsite Observation and Certificate Duration Requirements During
the COVID-19 Public Health Emergency: Guidance for Industry;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of availability.

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

SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing the availability of a final guidance for industry entitled
``Temporary Policy Regarding Accredited Third-Party Certification
Program Onsite Observation and Certificate Duration Requirements During
the COVID-19 Public Health Emergency.'' Given the public health
emergency presented by COVID-19, this guidance document is being
implemented without prior public comment because FDA has determined
that prior public participation is not feasible or appropriate, but it
remains subject to comment in accordance with the Agency's good
guidance practices. The guidance communicates the Agency's intention
not to enforce certain requirements for the onsite monitoring
activities and certificates for the currently recognized accreditation
bodies (ABs) and accredited third-party certification bodies (CBs) in
the Accredited Third-Party Certification Program for human and animal
food in certain circumstances. Because travel restrictions and
advisories related to COVID-19 may impact the ability of recognized ABs
and accredited CBs to conduct onsite activities, this guidance provides
temporary flexibility so that recognized ABs can maintain the
accreditations of their CBs, and so that already-issued certifications
need not lapse, in certain circumstances.

DATES: The announcement of the guidance is published in the Federal
Register on April 30, 2020.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the

manner detailed (see ``Written/Paper Submissions'' and
``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2020-D-1304 for ``Temporary Policy Regarding Accredited Third-Party
Certification Program Onsite Observation and Certificate Duration
Requirements During the COVID-19 Public Health Emergency.'' Received
comments will be placed in the docket and, except for those submitted
as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see Sec.
10.115(g)(5) (21 CFR 10.115(g)(5))).
    Submit written requests for single copies of the guidance to the
Office of Compliance, Center for Food Safety and Applied Nutrition,
Food and Drug Administration (HFS-607), 5001 Campus Dr., College Park,
MD 20740. Send two self-addressed adhesive labels to assist that office
in processing your request. See the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance.

FOR FURTHER INFORMATION CONTACT: Doriliz De Leon, Center for Food
Safety and Applied Nutrition (HFS-607), Food and Drug Administration,
5001 Campus Dr., College Park, MD 20740,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    We are announcing the availability of a guidance for industry
entitled ``Temporary Policy Regarding Accredited Third-Party
Certification Program Onsite Observation and Certificate Duration
Requirements During the COVID-19 Public Health Emergency.'' This policy
relates to the circumstances that gave rise to the public health
emergency related to COVID-19 declared by the Department of Health and
Human Services.
    Given this public health emergency this guidance is being
implemented without prior public comment because FDA has determined
that prior public participation for this guidance is not feasible or
appropriate. This guidance document is being implemented immediately,
but it remains subject to comment in accordance with the Agency's good
guidance practices. The guidance represents the current thinking of FDA
on this topic and should be viewed only as recommendations, unless
specific regulatory or statutory requirements are cited.
    This guidance document concerns certain requirements for the
recognized ABs and accredited CBs in the Accredited Third-Party
Certification Program that was established in 21 CFR part 1, subpart M,
as part of our implementation of the FDA Food Safety Modernization Act
(Pub. L. 111-353). The Accredited Third-Party Certification Program
regulation (https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-accredited-third-party-certification) requires
recognized ABs to monitor the performance of the CB(s) they accredited.
While some of the monitoring activities can be conducted remotely, some
of the activities must be conducted onsite. The Accredited Third-Party
Certification Program regulation also requires that accredited CBs can
issue certificates for a term only up to 12 months.
    Due to the impact of the travel restrictions and advisories related
to COVID-19, this guidance provides flexibility to the recognized ABs
and accredited CBs in the Accredited Third-Party Certification Program
for certain requirements related to the onsite monitoring activities
and certificates that have already been issued, in certain
circumstances.

II. Paperwork Reduction Act of 1995

    This guidance refers to previously approved FDA collections of
information. These collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501-3521). The collections of information in in
part 1, subpart M, have been approved under OMB control number 0910-
0750.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at
https://www.fda.gov/FoodGuidances, https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/coronavirus-disease-2019-covid-19
or https://www.regulations.gov. Use the FDA website listed in the
previous sentence to find the most current version of the guidance.

    Dated: April 24, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-09169 Filed 4-29-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 83, Number 234 (Thursday, December 6, 2018)]
[Notices]
[Pages 62930-62932]
[FR Doc No: 2018-26515]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-84698; File No. SR-CBOE-2018-073]

Self-Regulatory Organizations; Cboe Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change To Amend
Rule 5.8, Long-Term Equity Options Series (LEAPS)

November 30, 2018.
    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 November 23, 2018, Cboe Exchange, Inc. (``Exchange'' or ``Cboe
Options'') 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.
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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

    Cboe Exchange, Inc. (the ``Exchange'' or ``Cboe Options'') proposes
to amend Rule 5.8, Long-Term Equity Options Series (LEAPS). The text of
the proposed rule change is provided below.
    (additions are italicized; deletions are [bracketed])
* * * * *
Rules of Cboe Exchange, Inc.
* * * * *
Rule 5.8. Long-Term Equity Option Series (LEAPS)
    (a) Notwithstanding conflicting language in Exchange Rule 5.5, the
Exchange may list long-term equity option series (LEAPS) that expire
from 12 to 180 months from the time they are listed. There may be up to
ten additional expiration months for

options on SPY and up to six additional expiration months for all other
option classes.
* * * * *
    The text of the proposed rule change is also available on the
Exchange's website (http://www.cboe.com/AboutCBOE/CBOELegalRegulatoryHome.aspx), at the Exchange's Office of the
Secretary, and at the Commission's Public Reference Room.

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

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

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

1. Purpose
    The Exchange proposes to amend Rule 5.8, Long-Term Equity Option
Series (LEAPS), to permit the listing and trading of up to ten long-
term expiration months for long-term options on the SPDR[supreg] S&P
500[supreg] exchange-traded fund (``SPY'') in response to customer
demand.\3\ Rule 5.8 currently provides that the Exchange may list long-
term option contracts that expire from 12 to 180 months from the time
they are listed (LEAPS). There may be up to six long-term expiration
months per option class. The proposal will add liquidity to the SPY
options market by allowing market participants to hedge risks relating
to SPY positions over a longer period with a known and limited cost.
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    \3\ In contrast to Rule 5.8, Rule 24.9(b)(1)(B) (which applies
to index options) permits the Exchange to list long-term index
options series based on either the full or reduced value of the
underlying index, adding up to ten (10) expiration months. The
Exchange seeks to list ten (10) long-term expiration months on SPY,
just as it now may list ten (10) expiration months on long-term
index option series, in order to provide investors with a wider
choice of investments.
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    The SPY options market today is characterized by its tremendous
daily and annual liquidity. As a consequence, the Exchange believes
that the listing of additional SPY long-term expiration months would be
well received by investors. This proposal to expand the number of
permitted SPY long-term expiration months would not apply to long-term
expiration months on any other class of options.\4\
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    \4\ Historically, SPY is the largest and most actively traded
ETF in the United States as measured by its assets under management
and the value of shares traded.
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    The Exchange proposes to implement the proposed rule change on the
date of this rule filing.
2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
the Securities Exchange Act of 1934 (the ``Act'') and the rules and
regulations thereunder applicable to the Exchange and, in particular,
the requirements of Section 6(b) of the Act.\5\ Specifically, the
Exchange believes the proposed rule change is consistent with the
Section 6(b)(5) \6\ requirements that the rules of an exchange be
designed to prevent fraudulent and manipulative acts and practices, to
promote just and equitable principles of trade, to foster cooperation
and coordination with persons engaged in regulating, clearing,
settling, processing information with respect to, and facilitating
transactions in securities, to remove impediments to and perfect the
mechanism of a free and open market and a national market system, and,
in general, to protect investors and the public interest. Additionally,
the Exchange believes the proposed rule change is consistent with the
Section 6(b)(5) \7\ requirement that the rules of an exchange not be
designed to permit unfair discrimination between customers, issuers,
brokers, or dealers.
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    \5\ 15 U.S.C. 78f(b).
    \6\ 15 U.S.C. 78f(b)(5).
    \7\ Id.
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    In particular, the proposed rule change offers market participants
additional long-term expiration months on SPY options for their
investment and risk management purposes. The proposal is intended
simply to provide additional trading opportunities which have been
requested by customers, thereby facilitating transactions in options
and contributing to the protection of investors and the maintenance of
fair and orderly markets. The proposed rule change responds to the
continuing needs of market participants, particularly portfolio
managers and other institutional customers, by providing protection
from long-term market moves and by offering an alternative to hedging
portfolios with future positions or off-exchange customized derivative
instruments.
    Rule 5.8 has permitted up to six (6) long-term expiration months in
option classes since 1991, when it increased the number of permissible
expiration months from four to six.\8\ Other exchanges, such as Nasdaq
PHLX LLC (``Phlx''), have similarly permitted up to six ``LEAPS'' since
1991.\9\ When the Securities and Exchange Commission (the
``Commission'') approved the increase to six expiration months, the
Commission stated that it did not believe that increasing the number of
expiration months to six would cause, by itself, a proliferation of
expiration months. The Commission also required that the Exchange
monitor the volume of additional options series listed as a result of
the rule change, and the effect on the Exchange's system capacity and
quotation dissemination displays.\10\
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    \8\ See Securities Exchange Act Release No. 28890 (February 15,
1991), 56 FR 7439 (February 22, 1991) (approving SR-CBOE-90-32).
    \9\ See Securities Exchange Act Release No. 84449 (October 18,
2018), 83 FR 53699 (October 24, 2018) (SR-Phlx-2018-64); see also
Securities Exchange Act Release No. 29103 (April 18, 1991), 56 FR
19132 (April 25, 1991) (approving SR-Phlx-91-18).
    \10\ See Securities Exchange Act Release No. 28890 (February 15,
1991), 56 FR 7439 (February 22, 1991) (approving SR-CBOE-90-32).
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    The Exchange believes that the addition today of four (4)
additional long-term expiration months on SPY options likewise does not
represent a proliferation of expiration months, but is instead a very
modest expansion of long-term options in response to stated customer
demand. Significantly, the proposal would feature new long-term
expiration months in only a single class of options that are very
liquid and heavily traded, as discussed above. Additionally, the
Exchange notes by way of precedent, that ten (10) expiration months are
already permitted for long-term index options series. Further, the
Exchange has the necessary systems capacity to support the new SPY
long-term expiration months.

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 that is not necessary or appropriate
in furtherance of the purposes of the Act. The proposal merely provides
investors additional investment and risk management opportunities by
providing flexibility to the Exchange to list additional long-term
options expiration series, expanding the number of SPY long-term
expiration months offered on the Exchange from six (6) long-term
expiration months to ten (10) long-term expiration months. Other
options exchanges currently permit the listing of

ten (10) long-term expiration months for SPY.\11\
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    \11\ See, e.g., Phlx Rule 1012(a)(i)(D); Miami International
Securities Exchange, LLC (``MIAX'') Rule 406(a); and NYSE Arca, Inc.
(``Arca'') Rule 6.4-O(d)(i).
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C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

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

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

    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, it has become
effective pursuant to Section 19(b)(3)(A) of the Act \12\ and Rule 19b-
4(f)(6) thereunder.\13\
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    \12\ 15 U.S.C. 78s(b)(3)(A).
    \13\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change, along
with a brief description and text of 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 Commission has waived this requirement in this case.
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    A proposed rule change filed under Rule 19b-4(f)(6) \14\ normally
does not become operative prior to 30 days after the date of the
filing. However, pursuant to Rule 19b-4(f)(6)(iii),\15\ the Commission
may designate a shorter time if such action is consistent with the
protection of investors and the public interest. The Exchange has asked
the Commission to waive the 30-day operative delay so that the proposal
may become operative upon filing. The Exchange's proposal would conform
the Exchange's rules relating to the permitted number of long term
expiration months for long-term options on SPY to those of other
exchanges.\16\ Accordingly, the Commission believes that the proposal
raises no new or novel regulatory issues, and waiver of the 30-day
operative delay is consistent with the protection of investors and the
public interest. The Commission therefore waives the 30-day operative
delay and designates the proposal operative upon filing.\17\
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    \14\ Id.
    \15\ 17 CFR 240.19b-4(f)(6)(iii).
    \16\ See supra note 11.
    \17\ 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).
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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 protected]. Please include
File Number SR-CBOE-2018-073 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-CBOE-2018-073. 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-CBOE-2018-073, and should be submitted
on or before December 27, 2018.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\18\
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    \18\ 17 CFR 200.30-3(a)(12).
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Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2018-26515 Filed 12-4-18; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register: December 1, 2009 (Volume 229, Number 74)]
[Notices]
[Page 62795-62796]
[DOCID:fr01de09-79]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0524]

Guidance for Industry on Listing of Ingredients in Tobacco
Products; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance entitled ``Listing of Ingredients in Tobacco
Products.'' The guidance document is intended to assist persons making
tobacco product ingredient submissions to FDA under the Family Smoking
Prevention and Tobacco Control Act (Tobacco Control Act).

DATES: Submit written or electronic comments on this guidance at any
time. General comments on agency guidance documents are welcome at any
time.

ADDRESSES: Submit written requests for single copies of the guidance
document entitled ``Listing of Ingredients in Tobacco Products'' to the
Center for Tobacco Products, Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850-3229. Send one self-addressed
adhesive label to assist that office in processing your request or
include a fax number to which the guidance document may be sent. See
the SUPPLEMENTARY INFORMATION section for information on electronic
access to the guidance document.
    Submit written comments on the guidance to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Submit electronic comments to http://
www.regulations.gov. Identify comments with the docket number found in
brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Michele Mital, Center for Tobacco
Products, Food and Drug Administration, 9200 Corporate Blvd.,
Rockville, MD 20850-3229,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of November 3, 2009 (74 FR 56842), FDA
announced the availability of a draft guidance document entitled
``Listing of Ingredients in Tobacco Products.'' The agency considered
received comments as it finalized this guidance. This guidance document
is designed to assist tobacco product manufacturers and importers with
making tobacco product ingredient submissions to FDA. Under section
904(a)(1) of the Federal Food, Drug, and Cosmetic Act (the act) (21
U.S.C. 387d(a)(1)), as amended by the Tobacco Control Act, each tobacco
product manufacturer or importer, or agent thereof, is required to
submit ``a listing of all ingredients, including tobacco, substances,
compounds, and additives that are * * * added by the manufacturer to
the tobacco, paper, filter, or other part of each tobacco product by
brand and by quantity in each brand and subbrand.'' For tobacco
products on the market as of June 22, 2009, information must be
submitted to FDA by December 22, 2009, and include the ingredients
added as of the date of submission. FDA does not, however, intend to
enforce the statutory deadline of this subsection provided the
ingredient list is submitted on or before June 22, 2010. For tobacco
products not on the market as of June 22, 2009, section 904(c)(1)
requires that the list of ingredients be submitted at least 90 days
prior to delivery for introduction into interstate commerce. Section
904(c) of the act also requires submission of information whenever
additives, or the quantities of additives, are changed. FDA does not,
however, intend to enforce the statutory deadlines for ingredient
reporting under section 904(c) of the act for additive changes or the
initial introduction of products into interstate commerce occurring
between June 22, 2009, and 90 days after the section 904(a)(1)
ingredient list is submitted, provided that these report(s) are
submitted at the time of the section 904(a)(1) submission and the
report(s) include the date, or planned date, of making the change to
the additive or introducing the product into interstate commerce.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
agency's current thinking on ``Listing of Ingredients in Tobacco
Products.'' It does not create or confer any rights for or on any
person and does not operate to bind FDA or the public. An alternative
approach may be used if such approach satisfies the requirements of the
applicable statute and regulations.

III. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.

IV. Paperwork Reduction Act of 1995

    This guidance contains information collection provisions that 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
collection of information in this guidance was approved under OMB
control number 0910-0650.

V. Electronic Access

    An electronic version of the guidance document is available on the
Internet at http://www.regulations.gov and http://www.fda.gov/
TobaccoProducts/GuidanceComplianceRegulatoryInformation/default.htm.

    Dated: November 25, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-28747 Filed 11-27-09; 11:15 am]

BILLING CODE 4160-01-S