[Federal Register Volume 86, Number 191 (Wednesday, October 6, 2021)]
[Notices]
[Pages 55619-55620]
[FR Doc No: 2021-21688]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-D-1402]

Biomarkers and Surrogate Endpoints in Clinical Studies To Support
Effectiveness of New Animal Drugs; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, Health and Human Services (HHS).

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing the availability of a final guidance for industry (GFI) #267
entitled ``Biomarkers and Surrogate Endpoints in Clinical Studies to
Support Effectiveness of New Animal Drugs.'' The guidance describes
FDA's current thinking with respect to incorporating biomarkers and
surrogate endpoints into proposed clinical investigational protocols
and applications for new animal drugs under the Federal Food, Drug, and
Cosmetic Act (FD&C Act).

DATES: The announcement of the guidance is published in the Federal
Register on October 6, 2021.

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-1402 for ``Biomarkers and Surrogate Endpoints in Clinical
Studies to Support Effectiveness of New Animal Drugs.'' 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,<PHONE_NUMBER>.
     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,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the guidance to the
Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine,
Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855.
Send one self-addressed adhesive label to assist that office in
processing your requests. See the SUPPLEMENTARY INFORMATION section for
electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Susan Storey, Center for Veterinary
Medicine (HFV-131), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of July 15, 2020 (85 FR 42879), FDA
published the notice of availability for a draft guidance entitled
``Biomarkers and Surrogate Endpoints in Clinical Studies to Support
Effectiveness of New Animal Drugs,'' giving interested persons until
October 13, 2020, to comment on the draft guidance. This final guidance
describes how the Center for Veterinary Medicine (CVM) intends to
evaluate biomarkers, including surrogate endpoints, when they are
incorporated into clinical investigations submitted to CVM to
demonstrate substantial evidence of effectiveness for new animal drug
applications or a reasonable expectation of effectiveness for
applications for conditional approval of a new animal drug. It also
describes how sponsors may obtain feedback from CVM on technical issues
related to the use of biomarkers before the submission of an
application.
    FDA received comments on the draft guidance and those comments were
considered as the guidance was finalized. For example, we received a
comment suggesting that we remove from the guidance discussion of
biomarkers and a new animal drug's mechanism of action (MOA) with the
thought that the MOA is not a primary endpoint and is, therefore, out
of the scope of the guidance. We revised this section of the final
guidance by adding examples of when consideration of a new animal
drug's MOA may be relevant for purposes of evaluating the use of
biomarkers. We also made other editorial changes to this final guidance
to improve clarity. The guidance announced in this notice finalizes the
draft guidance dated July 2020.
    This level 1 guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The guidance represents
the current thinking of FDA on ``Biomarkers and Surrogate Endpoints in
Clinical Studies to Support Effectiveness of New Animal Drugs.'' It
does not establish any rights for any person and is not binding on FDA
or the public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in FDA's guidance entitled ``Biomarkers and Surrogate
Endpoints in Clinical Studies to Support Effectiveness of New Animal
Drugs'' have been approved under OMB control number 0910-0032.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at
either https://www.fda.gov/animal-veterinary/guidance-regulations/guidance-industry, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: September 29, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-21688 Filed 10-5-21; 8:45 am]
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[Federal Register: November 17, 2009 (Volume 74, Number 220)]
[Notices]
[Page 59230-59231]
[DOCID:fr17no09-85]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2009-0001]

Agency Information Collection Activities: Proposed Collection;
Comment Request, 1660-NEW; FEMA Preparedness Grants; Driver's License
Security Grant Program (DLSGP)

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice; 60-day notice and request for comments; new information
collection; OMB No. 1660-NEW; No Form.

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SUMMARY: The Federal Emergency Management Agency, as part of its
continuing effort to reduce paperwork and respondent burden, invites
the general public and other Federal agencies to take this opportunity
to comment on a proposed new information collection. In accordance with
the Paperwork Reduction Act of 1995, this Notice seeks comments
concerning information collection activities required to administer the
Driver's License Security Grant Program (DLSGP).

DATES: Comments must be submitted on or before January 19, 2010.

ADDRESSES: To avoid duplicate submissions to the docket, please use
only one of the following means to submit comments:
    (1) Online. Submit comments at www.regulations.gov under docket ID
FEMA-2009-0001. Follow the instructions for submitting comments.
    (2) Mail. Submit written comments to Office of Chief Counsel,
Regulation and Policy Team, DHS/FEMA, 500 C Street, SW., Room 835,
Washington, DC 20472-3100.
    (3) Facsimile. Submit comments to<PHONE_NUMBER>.
    (4) E-mail. Submit comments to<EMAIL_ADDRESS>Include docket
ID FEMA-2009-0001 in the subject line.
    All submissions received must include the agency name and docket
ID. Regardless of the method used for submitting comments or material,
all submissions will be posted, without change, to the Federal
eRulemaking Portal at http://www.regulations.gov, and will include any
personal information you provide. Therefore, submitting this
information makes it public. You may wish to read the Privacy Act
notice that is available on the Privacy and Use Notice link on the
Administration Navigation Bar of http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Contact Alex Mrazik, Program Analyst,
Grants Program Directorate,<PHONE_NUMBER> for additional information.
You may contact the Records Management Branch for copies of the
proposed collection of information at facsimile number<PHONE_NUMBER>
or e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: FEMA's Driver's License Security Grant
Program (DLSGP, formerly known as REAL ID) is an important part of the
Administration's larger, coordinated effort--known as the Federal
Investment Strategy--to strengthen homeland security preparedness
against risks associated with potential terrorist attacks. The purpose
of DLSGP is to prevent terrorism, reduce fraud, and improve the
reliability and accuracy of personal identification documents States
and territories issue. DLSGP is authorized by section 204, Title II of
the REAL ID Act of 2005, Division B of the Emergency Supplemental
Appropriations Act for Defense, the Global War on Terror, and Tsunami
Relief, 2005 (Pub. L. 109-13) (49 U.S.C. 30301) The program utilizes
the ``Minimum Standards for Driver's Licenses and Identification Cards
Acceptable by Federal Agencies for Official Purposes: Final Rule,''
January 29, 2008, 6 CFR part 37.

Collection of Information

    Title: FEMA Preparedness Grants; Driver's License Security Grant
Program (DLSGP).
    Type of Information Collection: New information collection.
    OMB Number: 1660-NEW.
    Form Titles and Numbers: No Forms.
    Abstract: The DLSGP is an important tool among a comprehensive set
of measures to help strengthen the Nation against risks associated with
potential terrorist attacks. FEMA uses the information to evaluate
applicants' familiarity with the national preparedness architecture and
identify how elements of this architecture have been incorporated into
regional/state/local planning, operations, and investments. The Program
Narrative and Program Management Capabilities Work Plan provide the
State with a Driver's License Security Grant Program implementation
roadmap and tells the Department of Homeland Security (DHS) how grant
funding will be used. The Program Narrative is a separate document from
the Program Management Capabilities Work Plan, both of which help to
assess program implementation potential and a State's management
procedures and capabilities. The Program Narrative and the Program
Management Capabilities Work Plan are required upon grant application
and are reviewed by FEMA and the DHS Policy Office to determine funding
decisions and assists with project oversight.
    Affected Public: State, Local or Tribal Government.
    Estimated Total Annual Burden Hours: 168 Hours.

                                                                     Table A.12--Estimated Annualized Burden Hours and Costs
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                                                                                Number of      Avg. burden    Total annual                                    Total annual
              Type of respondent                      Form name/form number          Number of     responses per   per response     burden  (in     Avg. hourly    Annual number    respondent
                                                                                respondents     respondent      (in hours)        hours)         wage rate     of responses        cost
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State, Local or Tribal Government.............  Program Narrative and Program                 56               1               3             168          $32.20              56       $5,409.60
                                                 Management Capabilities Work
                                                 Plan.
                                                                                ---------------------------------------------------------------------------------------------------------------
    Total.....................................  ................................              56  ..............  ..............             168  ..............              56       $5,409.60
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    Estimated Cost: There is no annual reporting or recordkeeping costs
associated with this collection.

Comments

    Comments may be submitted as indicated in the ADDRESSES caption
above. Comments are solicited to (a) evaluate whether the proposed data
collection is necessary for the proper performance of the agency,
including whether the information shall have practical utility; (b)
evaluate the accuracy of the agency's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (c) enhance the quality, utility, and
clarity of the information to be collected; and (d) minimize the burden
of the collection of information on those who are to respond, including
through the use of appropriate automated, electronic, mechanical, or
other technological collection techniques or other forms of information
technology, e.g., permitting electronic submission of responses.

Larry Gray,
Director, Records Management Division, Office of Management, Federal
Emergency Management Agency, Department of Homeland Security.
[FR Doc. E9-27560 Filed 11-16-09; 8:45 am]

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[Federal Register: November 27, 2007 (Volume 72, Number 227)]
[Notices]
[Page 66165-66167]
[DOCID:fr27no07-78]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OA-2007-0933; FRL-8499-6]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Confidential Financial Disclosure Form for Special
Government Employees Serving on Federal Advisory Committees at the U.S.
Environmental Protection Agency; EPA ICR No. 2260.02, OMB Control No.
2090-0029

AGENCY: Environmental Protection Agency.

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act (PRA) (44
U.S.C. 3501, et seq.), this document announces that EPA is planning to
submit a request to renew an existing approved Information Collection
Request (ICR) to the Office of Management and Budget (OMB). This ICR is
scheduled to expire on 2/29/2008. Before submitting the ICR to OMB for
review and approval, EPA is soliciting comments on specific aspects of
the proposed information collection as described below.

DATES: Comments must be submitted on or before January 28, 2008.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-OA-
2007-0933 by one of the following methods:

     http://www.regulations.gov: Follow the on-line instructions for

submitting comments.
     E-mail<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER>
     Mail: OEI Docket, USEPA, Mail Code: 2822T, 1200
Pennsylvania Ave., NW., Washington, DC 20460. Hand Delivery: EPA Docket
Center, EPA West Room 3334, 1301 Constitution Ave., NW., Washington, DC
20460. Such deliveries are only accepted during the Docket's normal
hours of operation, and special arrangements should be made for
deliveries of boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-OA-2007-
0933. EPA's policy is that all comments received will be included in
the public docket without change and may be made available online at
http://www.regulations.gov, including any personal information provided,

unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through http://www.regulations.gov or e-mail.

The http://www.regulations.gov Web site is an ``anonymous access'' system,

which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through http://www.regulations.gov

your e-mail address will be automatically captured and included as part
of the comment that is placed in the public docket and made available
on the Internet. If you submit an electronic comment, EPA recommends
that you include your name and other contact information in the body of
your comment and with any disk or CD-ROM you submit. 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. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses. For additional
information about EPA's public docket visit the EPA Docket Center
homepage at http://www.epa.gov/epahome/dockets.htm.

FOR FURTHER INFORMATION CONTACT: Vicki Ellis, Office of Cooperative
Environmental Management, Mail Code 1601M, Environmental Protection
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone
number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION:

How Can I Access the Docket and/or Submit Comments?

    EPA has established a public docket for this ICR under Docket ID
No. EPA-HQ-OA-2007-0933, which is available for online viewing at
http://www.regulations.gov, or in person viewing at the Environmental

Information Docket in the EPA Docket Center (EPA/DC), EPA West Room
3334, 1301 Constitution Ave., NW., Washington, DC 20460. The EPA/DC
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 Reading
Room is<PHONE_NUMBER>, and the telephone number for the Environmental
Information Docket is<PHONE_NUMBER>.
    Use http://www.regulations.gov to obtain a copy of the draft collection of

information, submit or view public comments, access the index listing
of the contents of the docket, and to access those documents in the
public docket that are available electronically. Once in the system,
select ``search,'' then key in the docket ID number identified in this
document.

What Information Is EPA Particularly Interested In?

    Pursuant to section 3506(c)(2)(A) of the PRA, EPA specifically
solicits comments and information to enable it to:
    (i) Evaluate whether the proposed collection of information is
necessary for the proper performance of the functions of the Agency,
including whether the information will have practical utility;
    (ii) evaluate the accuracy of the Agency's estimate of the burden
of the proposed collection of information, including the validity of
the methodology and assumptions used;
    (iii) enhance the quality, utility, and clarity of the information
to be collected; and
    (iv) minimize the burden of the collection of information on those
who are to respond, including through the use of appropriate automated
electronic, mechanical, or other technological collection techniques or
other forms of information technology, e.g., permitting electronic
submission of responses. In particular, EPA is requesting comments from
very small businesses (those that employ less than 25) on examples of
specific additional efforts that EPA could make to reduce the paperwork
burden for very small businesses affected by this collection.

What Should I Consider When I Prepare My Comments for EPA?

    You may find the following suggestions helpful for preparing your
comments:
    1. Explain your views as clearly as possible and provide specific
examples.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used
that support your views.
    4. If you estimate potential burden or costs, explain how you
arrived at the estimate that you provide.
    5. Offer alternative ways to improve the collection activity.
    6. Make sure to submit your comments by the deadline identified
under DATES.
    7. To ensure proper receipt by EPA, be sure to identify the docket
ID number assigned to this action in the subject line on the first page
of your response. You may also provide the name, date, and Federal
Register citation.

What Information Collection Activity or ICR Does This Apply to?

    Affected entities: Entities potentially affected by this action are
approximately 300 candidates for membership as Special Government
Employees (SGEs) on EPA Federal advisory committees. The Form 3110-48
is completed as part of the member selection process and before they
are invited to serve as a member of a Federal advisory committee (FAC)
at EPA.
    Title: Confidential Financial Disclosure Form for Special
Government Employees Serving on Federal Advisory Committees at the U.S.
Environmental Protection Agency.
    ICR numbers: EPA ICR No. 2260.02, OMB Control No. 2090-0029.
    ICR status: This ICR is currently scheduled to expire on 02/29/
2008. An Agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information, unless it displays
a currently valid OMB control number. The OMB control numbers for EPA's
regulations in title 40 of the CFR, after appearing in the Federal
Register when approved, are listed in 40 CFR part 9, and are displayed
either by publication in the Federal Register or by other appropriate
means, such as on the related collection instrument or form, if
applicable. The display of OMB control numbers in certain EPA
regulations is consolidated in 40 CFR part 9.
    Abstract: The purpose of this information collection request is to
assist the United States Environmental

Protection Agency (EPA or the Agency) in selecting Federal advisory
committee members who will be appointed as Special Government Employees
(SGEs), mostly to EPA's scientific and technical committees. To select
SGE members as efficiently and cost effectively as possible, the Agency
needs to evaluate potential conflicts of interest before a candidate is
hired as an SGE and appointed as a member to a committee by EPA's
Administrator or Deputy Administrator.
    Agency officials developed the ``Confidential Financial Disclosure
Form for Special Government Employees Serving on Federal Advisory
Committees at the U.S. Environmental Protection Agency,'' also referred
to as Form 3110-48, for a greater inclusion of information to discover
any potential conflicts of interest as recommended by the Government
Accountability Office.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average one
hour per response. Burden means the total time, effort, or financial
resources expended by persons to generate, maintain, retain, or
disclose or provide information to or for a Federal agency. This
includes the time needed to review instructions; develop, acquire,
install, and utilize technology and systems for the purposes of
collecting, validating, and verifying information, processing and
maintaining information, and disclosing and providing information;
adjust the existing ways to comply with any previously applicable
instructions and requirements which have subsequently changed; train
personnel to be able to respond to a collection of information; search
data sources; complete and review the collection of information; and
transmit or otherwise disclose the information.
    The ICR provides a detailed explanation of the Agency's estimate,
which is only briefly summarized here:
     Estimated total number of potential respondents: 300.
     Frequency of response: Annual.
     Estimated total average number of responses for each
respondent: 1.
     Estimated total annual burden hours: 300 hours/1 hour per
respondent.
     Estimated total annual costs: $33,000. There are no
capital investment or maintenance and operational costs.

Are There Changes in the Estimates From the Last Approval?

    The burden estimates have been changed to reflect an expected
increase of the number of respondents (from 276 to 300), as well as an
increase of respondents' costs to complete the form, to cover the next
3 years.

What is the Next Step in the Process for This ICR?

    EPA will consider the comments received and amend the ICR as
appropriate. The final ICR package will then be submitted to OMB for
review and approval pursuant to 5 CFR 1320.12. At that time, EPA will
issue another Federal Register notice pursuant to 5 CFR
1320.5(a)(1)(iv) to announce the submission of the ICR to OMB and the
opportunity to submit additional comments to OMB. If you have any
questions about this ICR or the approval process, please contact Vicki
Ellis, Office of Cooperative Environmental Management, Mail Code 1601M,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax number: 202-
564-8129; e-mail address<EMAIL_ADDRESS>
    Dated: November 20, 2007.
Rafael DeLeon,
Director, Office of Cooperative Environmental Management, Office of the
Administrator.
[FR Doc. E7-23052 Filed 11-26-07; 8:45 am]

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[Federal Register Volume 79, Number 180 (Wednesday, September 17, 2014)]
[Notices]
[Page 55850]
[FR Doc No: 2014-22118]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-73083; File No. SR-EDGX-2014-18]

Self-Regulatory Organizations; EDGX Exchange, Inc.; Notice of
Designation of Longer Period for Commission Action on Proposed Rule
Change Relating To Include Additional Specificity Within Rule 1.5 and
Chapter XI Regarding Current System Functionality Including the
Operation of Order Types and Order Instructions

September 11, 2014.
    On July 16, 2014, EDGX Exchange, Inc. (the ``Exchange'' or
``EDGX'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change to amend Rule 1.5 and Chapter XI of its rule book
to include additional specificity regarding the current functionality
of the Exchange's System,\3\ including the operation of its order types
and order instructions, and to describe certain new system
functionality. The proposed rule change was published for comment in
the Federal Register on July 31, 2014.\4\ The Commission received one
comment letter.\5\
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ Exchange Rule 1.5(cc) defines ``System'' as ``the electronic
communications and trading facility designated by the Board through
which securities orders of Users are consolidated for ranking,
execution and, when applicable, routing away.''
    \4\ See Securities Exchange Act Release No. 72676 (July 25,
2014), 79 FR 44520.
    \5\ See Letter from Suzanne H. Shatto, dated August 19, 2014.
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    Section 19(b)(2) of the Act \6\ provides that within 45 days of the
publication of notice of the filing of a proposed rule change, or
within such longer period up to 90 days as the Commission may designate
if it finds such longer period to be appropriate and publishes its
reasons for so finding or as to which the self-regulatory organization
consents, the Commission shall either approve the proposed rule change,
disapprove the proposed rule change, or institute proceedings to
determine whether these proposed rule changes should be disapproved.
The 45th day for this filing is September 14, 2014.
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    \6\ 15 U.S.C. 78s(b)(2).
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    The Commission is extending the 45-day time period for Commission
action on the proposed rule change. The Commission finds that it is
appropriate to designate a longer period within which to take action on
the proposed rule change so that it has sufficient time to consider and
take action on the Exchange's proposed rule change.
    Accordingly, pursuant to Section 19(b)(2)(A)(ii)(I) of the Act \7\
and for the reasons stated above, the Commission designates October 29,
2014, as the date by which the Commission should either approve or
disapprove, or institute proceedings to determine whether to
disapprove, the proposed rule change (File No. SR-EDGX-2014-18).
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    \7\ 15 U.S.C. 78s(b)(2)(A)(ii)(I).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\8\
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    \8\ 17 CFR 200.30-3(a)(31).
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Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-22118 Filed 9-16-14; 8:45 am]
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