[Federal Register: August 5, 2008 (Volume 73, Number 151)]
[Notices]
[Page 45514-45515]
[DOCID:fr05au08-105]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Agency Information Collection Activity Seeking OMB Approval

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice.

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SUMMARY: The FAA invites public comments about our intention to request
the Office of Management and Budget's (OMB) revision of a current
information collection. The Federal Register Notice with a 60-day
comment period soliciting comments on the following collection of
information was published on May 14, 2008, vol. 73, no. 94, page 27885.
Collection of this information permits the FAA to evaluate its
certification standards, maintenance programs, and regulatory
requirements since their effectiveness is reflected in the number of
equipment failures or the lack thereof.

DATES: Please submit comments by September 4, 2008.

FOR FURTHER INFORMATION CONTACT: Carla Mauney at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Federal Aviation Administration (FAA)

    Title: Malfunction or Defect Report.
    Type of Request: Revision of a currently approved collection.
    OMB Control Number: 2120-0003.
    Form(s) 8010-4.
    Affected Public: An estimated 57,736 respondents.
    Frequency: This information is collected on occasion.
    Estimated Average Burden per Response: Approximately 9 minutes per
response.
    Estimated Annual Burden Hours: An estimated 8,653 hours annually.
    Abstract: Collection of this information permits the FAA to
evaluate its certification standards, maintenance programs, and
regulatory requirements since their effectiveness is reflected in the
number of equipment failures or the lack thereof. It is also the basis
for issuance of Airworthiness Directives designed to prevent unsafe
conditions and accidents.

ADDRESSES: Interested persons are invited to submit written comments on
the proposed information collection to the Office of Information and
Regulatory Affairs, Office of Management and Budget. Comments should be
addressed to Nathan Lesser, Desk Officer, Department of Tansportation/
FAA, and sent via electronic mail to<EMAIL_ADDRESS>or
faxed to<PHONE_NUMBER>.

    Comments are invited on: Whether the proposed collection of
information is necessary for the proper performance of the functions of
the Department, including whether the information will have practical
utility; the accuracy of the Department's estimates of the burden of
the proposed information collection; ways to enhance the quality,
utility, and clarity of the information to be collected; and ways to
minimize the burden of the collection of information on respondents,
including the use of automated collection techniques or other forms of
information technology.

    Issued in Washington, DC, on July 28, 2008.
Carla Mauney,
FAA Information Collection Clearance Officer, IT Enterprises Business
Services Division, AES-200.
[FR Doc. E8-17757 Filed 8-4-08; 8:45 am]

BILLING CODE 4910-13-M


[Federal Register Volume 77, Number 162 (Tuesday, August 21, 2012)]
[Notices]
[Pages 50502-50504]
[FR Doc No: 2012-20499]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL 9716-9]

California State Nonroad Engine Pollution Control Standards; In-
Use Heavy-Duty Vehicles (As Applicable to Yard Trucks and Two-Engine
Sweepers); Opportunity for Public Hearing and Comment

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of Opportunity for Public Hearing and Comment.

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SUMMARY: The California Air Resources Board (CARB) has notified EPA
that it has adopted and subsequently amended emission standards
applicable to yard trucks powered by off-road engines and the auxiliary
engines on two-engine sweepers. By letter dated March 2, 2012, CARB
submitted a request seeking EPA authorization of these standards under
section 209(e) of the Clean Air Act (CAA), 42 U.S.C. 7543(e). This
notice announces that EPA has tentatively scheduled a public hearing
concerning California's request and that EPA is accepting written
comment on the request.

DATES: EPA has tentatively scheduled a public hearing concerning CARB's
request on September 20, 2012 beginning at 10:00 a.m. The hearing will
be held at 1310 L St NW., Washington, DC 20005. Parties wishing to
present oral testimony at the public hearing should provide written
notification to David Dickinson at the address noted below. Should you
have further questions regarding the hearing, please contact David
Dickinson or you may consult the following Web site for any updates:
http://www.epa.gov/otaq/cafr.htm. If EPA does not receive a request for
a public hearing, then EPA will not hold a hearing, and instead
consider CARB's request based on written submissions to the docket. Any
party may submit written comments by October 22, 2012.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OAR-2012-0335, by one of the following methods:
     http://www.regulations.gov: Follow the on-line
instructions for submitting comments.
     Email<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER>.
     Mail: Air and Radiation Docket, Docket ID No. EPA-HQ-OAR-
2012-0335, Environmental Protection Agency, Mailcode: 6102T, 1200
Pennsylvania Avenue NW., Washington, DC 20460. Please include a total
of two copies.

     Hand Delivery: EPA Docket Center, Public Reading Room, EPA
West Building, Room 3334, 1301 Constitution Avenue 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-OAR-
2012-0335. 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 email. 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 email comment directly to EPA without
going through http://www.regulations.gov, your email 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.
    Parties wishing to present oral testimony at the public hearing
should provide written notice to David Dickinson at the address noted
below. If EPA receives a request for a public hearing, EPA will hold
the public hearing at 1310 L St. NW., Washington, DC 20005 at 10:00
a.m.

FOR FURTHER INFORMATION CONTACT: David Dickinson, Compliance Division
(6405J), U.S. Environmental Protection Agency, 1200 Pennsylvania Ave
NW., Washington, DC 20460. Telephone:<PHONE_NUMBER>, Fax: (202) 343-
2804, email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background and Discussion

    Section 209(e)(1) of the Act permanently preempts any State, or
political subdivision thereof, from adopting or attempting to enforce
any standard or other requirement relating to the control of emissions
for certain new nonroad engines or vehicles.\1\ For all other nonroad
engines (including any engine that is no longer ``new''), States are
preempted from adopting and enforcing standards and other requirements
relating to the control of emissions, except that section 209(e)(2) of
the Act requires EPA to grant California authorization to adopt and
enforce such regulations unless EPA makes one of three specifically
enumerated findings. In addition, other States with attainment plans
may adopt and enforce such regulations if the standards, and
implementation and enforcement, are identical to California's
standards. On July 20, 1994, EPA promulgated a rule that sets forth,
among other things, regulations providing the criteria, as found in
section 209(e)(2), which EPA must consider before granting any
California authorization request for new nonroad engine or vehicle
emission standards.\2\ EPA revised these regulations in 1997.\3\ As
stated in the preamble to the 1994 rule, EPA has historically
interpreted the section 209(e)(2)(iii) ``consistency'' inquiry to
require, at minimum, that California standards and enforcement
procedures be consistent with section 209(a), section 209(e)(1), and
section 209(b)(1)(C) (as EPA has interpreted that subsection in the
context of section 209(b) motor vehicle waivers).\4\
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    \1\ States are expressly preempted from adopting or attempting
to enforce any standard or other requirement relating to the control
of emissions from new nonroad engines which are used in construction
equipment or vehicles or used in farm equipment or vehicles and
which are smaller than 175 horsepower. Such express preemption under
section 209(e)(1) of the Act also applies to new locomotives or new
engines used in locomotives.
    \2\ 59 FR 36969 (July 20, 1994).
    \3\ See 62 FR 67733 (December 30, 1997). The applicable
regulations, now in 40 CFR part 1074, subpart B, Sec.  1074.105,
provide:
    (a) The Administrator will grant the authorization if California
determines that its standards will be, in the aggregate, at least as
protective of public health and welfare as otherwise applicable
federal standards.
    (b) The authorization will not be granted if the Administrator
finds that any of the following are true:
    (1) California's determination is arbitrary and capricious.
    (2) California does not need such standards to meet compelling
and extraordinary conditions.
    (3) The California standards and accompanying enforcement
procedures are not consistent with section 209 of the Act.
    (c) In considering any request from California to authorize the
state to adopt or enforce standards or other requirements relating
to the control of emissions from new nonroad spark-ignition engines
smaller than 50 horsepower, the Administrator will give appropriate
consideration to safety factors (including the potential increased
risk of burn or fire) associated with compliance with the California
standard.
    \4\ See 59 FR 36969 (July 20, 1994).
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    In order to be consistent with section 209(a), California's nonroad
standards and enforcement procedures must not apply to new motor
vehicles or new motor vehicle engines. To be consistent with section
209(e)(1), California's nonroad standards and enforcement procedures
must not attempt to regulate engine categories that are permanently
preempted from state regulation. To determine consistency with section
209(b)(1)(C), EPA typically reviews nonroad authorization requests
under the same ``consistency'' criteria that are applied to motor
vehicle waiver requests. Pursuant to section 209(b)(1)(C), the
Administrator shall not grant California a motor vehicle waiver if she
finds that California ``standards and accompanying enforcement
procedures are not consistent with section 202(a)'' of the Act.
Previous decisions granting waivers and authorizations have noted that
state standards and enforcement procedures are inconsistent with
section 202(a) if: (1) There is inadequate lead time to permit the
development of the necessary technology giving appropriate
consideration to the cost of compliance within that time, or (2) the
federal and state testing procedures impose inconsistent certification
requirements.
    CARB has submitted to EPA, for authorization, its yard trucks
powered by off-road engines and the auxiliary engines on two-engine
sweepers provisions from its ``Regulation to Reduce Emissions of Diesel
Particulate Matter, Oxides of Nitrogen and Other Criteria Pollutants
from In-Use Heavy-Duty Diesel-Fueled Vehicles'' (commonly referred to
as the ``Truck and Bus Regulation'') initially adopted by CARB on
December 11, 2008 and subsequently amended on September 19, 2011.\5\
The Truck and Bus Regulation principally applies to non-new on-road
motor vehicles, which is not the subject of this notice. The Truck and
Bus Regulation also applies to any nonroad engines used to power yard
trucks (which are principally used in off-road agricultural operations)
and the

auxiliary engine used to power the broom or vacuum functions on two-
engine sweepers.\6\
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    \5\ CARB did not submit the entire Truck and Bus Regulation to
EPA for waiver or authorization consideration. The regulation is
codified at Title 13, California Code of Regulations, section 2025.
    \6\ The definition of yard truck is at section 2025 and two-
engine sweeper is defined at 2025(d)(58).
---------------------------------------------------------------------------

    As stated above, EPA is offering the opportunity for a public
hearing, and requesting written comments on issues relevant to a full
waiver analysis. Specifically, please provide comment on: (a) Whether
CARB's determination that its standards, in the aggregate, are at least
as protective of public health and welfare as applicable federal
standards is arbitrary and capricious, (b) California needs separate
standards to meet compelling and extraordinary conditions, and (c)
California's standards and accompanying enforcement procedures are
consistent with section 209 of the Act.

II. Procedures for Public Participation

    If a hearing is held, the Agency will make a verbatim record of the
proceedings. Interested parties may arrange with the reporter at the
hearing to obtain a copy of the transcript at their own expense.
Regardless of whether a public hearing is held, EPA will keep the
record open until October 22, 2012. Upon expiration of the comment
period, the Administrator will render a decision on CARB's request
based on the record of the public hearing, if any, relevant written
submissions, and other information that he deems pertinent.
    Persons with comments containing proprietary information must
distinguish such information from other comments to the great possible
extent and label it as ``Confidential Business Information'' (CBI). If
a person making comments want EPA to base its decision in part on a
submission labeled CBI, then a non-confidential version of the document
that summarizes the key data or information should be submitted for the
public docket. To ensure that proprietary information in not
inadvertently place in the docket, submissions containing such
information should be sent directly to the contact person listed above
and not to the pubic docket. Information covered by a claim of
confidentiality will be disclosed by EPA only to the extent allowed and
by the procedures set forth in 40 CFR Part 2. If no claim of
confidentiality accompanies the submission when EPA receives it, EPA
will make it available to the public without further notice to the
person making comments.

    Dated: August 9, 2012.
Margo Tsirigotis Oge,
Director, Office of Transportation and Air Quality, Office of Air and
Radiation.
[FR Doc. 2012-20499 Filed 8-20-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 88, Number 172 (Thursday, September 7, 2023)]
[Notices]
[Pages 61600-61602]
[FR Doc No: 2023-19283]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2023-D-3132, FDA-2023-D-3133, and FDA-2023-D-3134]

Modernizing the Food and Drug Administration's Premarket
Notification Program; Draft Guidances for Industry and Food and Drug
Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of three draft guidances entitled ``Evidentiary
Expectations for 510(k) Implant Devices,'' ``Recommendations for the
Use of Clinical Data in Premarket Notification [510(k)] Submissions,''
and ``Best Practices for Selecting a Predicate Device to Support a
Premarket Notification [510(k)] Submission.'' FDA is issuing these
guidances to improve the predictability, consistency, and transparency
of the 510(k) premarket review process. The draft guidances are not
final nor are they for implementation at this time.

DATES: Submit either electronic or written comments on the draft
guidance by December 6, 2023 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance 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 Docket No. FDA-
2023-D-3132 for ``Evidentiary Expectations for 510(k) Implant
Devices,'' Docket No. FDA-2023-D-3133 for ``Recommendations for the Use
of Clinical Data in Premarket Notification [510(k)] Submissions,'' or
Docket No. FDA-2023-D-3134 for ``Best Practices for Selecting a
Predicate Device to Support a Premarket Notification [510(k)]
Submission.'' 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)).
    An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the draft guidance document entitled
``Evidentiary Expectations for 510(k) Implant Devices,''
``Recommendations for the Use of Clinical Data in Premarket
Notification [510(k)] Submissions,'' or ``Best Practices for Selecting
a Predicate Device to Support a Premarket Notification [510(k)]
Submission'' to the Office of Policy, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your
request.

FOR FURTHER INFORMATION CONTACT: Angela DeMarco, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 2436, Silver Spring, MD 20993-0002,<PHONE_NUMBER>;
or Anne Taylor, Center for Biologics Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7242,
Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    As part of FDA's Medical Device Safety Action Plan: Protecting
Patients, Promoting Public Health,\1\ FDA committed to strengthen and
modernize the premarket notification (510(k)) Program. FDA is issuing
these three draft guidances to enhance the transparency, consistency,
and predictability of the 510(k) premarket review process.
---------------------------------------------------------------------------

    \1\ Available at https://www.fda.gov/about-fda/cdrh-reports/medical-device-safety-action-plan-protecting-patients-promoting-public-health.
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    In ``Evidentiary Expectations for 510(k) Implant Devices,'' FDA
discusses considerations that are generally relevant to all types of
implants subject to 510(k) requirements. This draft guidance is
intended to serve as a primary resource, used in conjunction with other
guidances, to provide clarity and facilitate discussions regarding
expectations for performance data that may be necessary to establish
substantial equivalence for implanted medical devices. However, the
type and quantity of performance data needed to support a substantial
equivalence determination for a particular device will vary depending
on the device and/or device type and on the differences from the
predicate device.
    In ``Recommendations for the Use of Clinical Data in Premarket
Notification [510(k)] Submissions,'' FDA clarifies and provides
additional context for situations when clinical data may be necessary
to demonstrate substantial equivalence, as initially described in the
final guidance ``The 510(k) Program: Evaluating Substantial Equivalence
in Premarket Notifications [510(k)]'' \2\ (``510(k) Program
Guidance''). This draft guidance expands on the scenarios described in
the 510(k) Program Guidance, describes another scenario, and provides
additional examples to illustrate when clinical data may or may not be
necessary to include in a 510(k) submission to demonstrate substantial
equivalence.
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    \2\ Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/510k-program-evaluating-substantial-equivalence-premarket-notifications-510k.
---------------------------------------------------------------------------

    Finally, in ``Best Practices for Selecting a Predicate Device to
Support a Premarket Notification [510(k)] Submission,'' FDA proposes
four best practices for choosing a predicate device used to support a
510(k) submission. Initially, FDA considered making public on its
website those cleared devices that demonstrated substantial equivalence
to older predicate devices. FDA also considered focusing on predicates
that were more than 10 years old as a starting point. FDA issued a
public notice on its website that requested public comment on this
proposal.\3\ After considering the docket comments, FDA believes use of
best practices that encourage the use of predicate devices with certain
characteristics, rather than focusing on the age of the predicate, will
support modernization of the 510(k) Program with respect to the use of
predicate devices and encourage the evolution of safer and more
effective medical devices.
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    \3\ Available at https://wayback.archive-it.org/7993/20190206202131/https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHReports/ucm604500.htm.
Public comments submitted can be searched under the docket FDA-2018-
N-4751, available at https://www.regulations.gov/docket/FDA-2018-N-4751.
---------------------------------------------------------------------------

    These draft guidances are being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidances,
when finalized, will represent the current thinking of FDA on the
topics discussed in ``Evidentiary Expectations for 510(k) Implant
Devices,'' ``Recommendations for the Use of Clinical Data in Premarket
Notification [510(k)] Submissions,'' and ``Best Practices for Selecting
a Predicate Device to Support a Premarket Notification [510(k)]
Submission.'' These draft guidances do not establish any rights for any
person and are 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. Electronic Access

    Persons interested in obtaining copies of these draft guidances may
do so by downloading electronic copies from the internet. A search
capability for all Center for Devices and Radiological Health guidance
documents is available at https://www.fda.gov/medical-devices/device-
advice-comprehensive-

regulatory-assistance/guidance-documents-medical-devices-and-radiation-
emitting-products. These guidance documents are also available at
https://www.regulations.gov, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics. Persons unable to download an electronic copy of
``Evidentiary Expectations for 510(k) Implant Devices'' (document
number GUI00020017), ``Recommendations for the Use of Clinical Data in
Premarket Notification [510(k)] Submissions'' (document number
GUI00020016), or ``Best Practices for Selecting a Predicate Device to
Support a Premarket Notification [510(k)] Submission'' (document number
GUI00020006) may send an email request to [email protected] to
receive an electronic copy of the document. Please use the document
number and complete title to identify the guidance you are requesting.

III. Paperwork Reduction Act of 1995

    While these guidances contain no new collection of information,
they do refer to previously approved FDA collections of information.
The previously approved collections of information are subject to
review by the Office of Management and Budget (OMB) under the Paperwork
Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of
information in the following table have been approved by OMB:

------------------------------------------------------------------------
 21 CFR part; guidance; or FDA                              OMB control
              form                        Topic                 No.
------------------------------------------------------------------------
807, subpart E.................  Premarket notification.       0910-0120
``Requests for Feedback and      Q-Submissions and Early       0910-0756
 Meetings for Medical Device      Payor Feedback Request
 Submissions: The Q-Submission    Programs for Medical
 Program''.                       Devices.
800, 801, 809, and 830.........  Medical Device Labeling       0910-0485
                                  Regulations; Unique
                                  Device Identification.
803............................  Medical Devices;              0910-0437
                                  Medical Device
                                  Reporting;
                                  Manufacturer
                                  reporting, importer
                                  reporting, user
                                  facility reporting,
                                  distributor reporting.
810............................  Medical Device Recalls.       0910-0432
820............................  Current Good                  0910-0073
                                  Manufacturing Practice
                                  (CGMP); Quality System
                                  (QS) Regulation.
822............................  Postmarket Surveillance       0910-0449
                                  of Medical Devices.
Forms FDA 3500 and FDA 3500A...  Medical device adverse        0910-0291
                                  event reporting--
                                  MedWatch.
58.............................  Good Laboratory               0910-0119
                                  Practice (GLP)
                                  Regulations for
                                  Nonclinical Laboratory
                                  Studies.
------------------------------------------------------------------------

    Dated: September 1, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-19283 Filed 9-6-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 80, Number 32 (Wednesday, February 18, 2015)]
[Rules and Regulations]
[Pages 8511-8513]
[FR Doc No: 2015-02672]

========================================================================
Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents.
Prices of new books are listed in the first FEDERAL REGISTER issue of each
week.

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

Federal Register / Vol. 80, No. 32 / Wednesday, February 18, 2015 /
Rules and Regulations

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2014-0620; Directorate Identifier 2013-NM-238-AD;
Amendment 39-18102; AD 2015-03-06]
RIN 2120-AA64

Airworthiness Directives; Airbus Airplanes

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

ACTION: Final rule.

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SUMMARY: We are superseding Airworthiness Directive (AD) 2007-22-10 for
all Airbus Model A330-200, A330-300, A340-200, A340-300, A340-500, and
A340-600 series airplanes. AD 2007-22-10 required repetitive
inspections of the left-hand and right-hand wing main landing gear
(MLG) rib 6 aft bearing lugs (forward and aft) to detect any cracks on
the two lugs, and replacement if necessary. Since we issued AD 2007-22-
10, we have received reports of additional cracking of the MLG rib 6
aft bearing forward lug. This new AD expands the applicability and
reduces certain compliance times. We are issuing this AD to detect and
correct cracking of the MLG rib 6 aft bearing lugs, which could result
in collapse of the MLG upon landing.

DATES: This AD becomes effective March 25, 2015.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in this AD as of March 25,
2015.

ADDRESSES: You may examine the AD docket on the Internet at http://www.regulations.gov/#!docketDetail;D=FAA-2014-0620; or in person at the
Docket Management Facility, U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC.
    For service information identified in this AD, contact Airbus SAS,
Airworthiness Office--EAL, 1 Rond Point Maurice Bellonte, 31707 Blagnac
Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 45 80;
email airworthiness.A330<EMAIL_ADDRESS>Internet http://www.airbus.com. You may view this referenced service information at the
FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA.
For information on the availability of this material at the FAA, call
425-227-1221. It is also available on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2014-
0620.

FOR FURTHER INFORMATION CONTACT: Vladimir Ulyanov, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue SW., Renton, WA 98057-3356; telephone<PHONE_NUMBER>;
fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to supersede AD 2007-22-10, Amendment 39-15246 (72 FR 61796,
November 1, 2007; corrected November 16, 2007 (72 FR 64532)). AD 2007-
22-10 applied to all Airbus Model A330-200, A330-300, A340-200, A340-
300, A340-500, and A340-600 series airplanes. The NPRM published in the
Federal Register on September 4, 2014 (79 FR 52585).
    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Union, has issued EASA
Airworthiness Directive 2013-0271, dated November 14, 2013 (referred to
after this as the Mandatory Continuing Airworthiness Information, or
``the MCAI''), to correct an unsafe condition. The MCAI states:

    During Main Landing Gear (MLG) lubrication, a crack was visually
found in the MLG rib 6 aft bearing forward lug on one A330 in-
service aeroplane. The crack had extended through the entire
thickness of the forward lug at approximately the 4 o'clock position
(when looking forward). It has been determined that similar type of
crack can develop on other aeroplane types that are listed in the
Applicability paragraph.
    This condition, if not detected and corrected, could affect the
structural integrity of the MLG attachment.
    To address this situation, Airbus issued inspection Service
Bulletins (SB) A330-57-3096, A340-57-4104 and A340-57-5009 to
instruct repetitive inspection of the gear rib lugs.
    Prompted by these findings, EASA issued Emergency AD 2006-0364-E
to require repetitive detailed visual inspections of the Left Hand
(LH) and Right Hand (RH) wing MLG rib 6 aft bearing lugs. Later EASA
issued AD 2007-0247R1-E, which superseded EAD 2006-0364-E, to:

--Expand the applicability to all A330 and A340 aeroplanes, because
the interference fit bushes cannot be considered as a terminating
action, owing to unknown root cause; and
--Add a second parameter quoted in Flight Hours (FH) to the
inspection interval in order to reflect the aeroplane utilization in
service.

    EASA AD 2007-0247R1-E was republished to correct a typographical
error.
    Since the first crack finding and issuance of the inspection SBs
and related ADs, six further cracks have been reported.
    For the reasons described above, this [EASA] AD, which
supersedes EASA EAD 2007-0247 R1-E and retains its requirements, is
issued to expand the applicability to the newly certified models
A330-223F and A330-243F and to reduce the threshold further to the
risk assessment of recent in-service experience.

    You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov/#!documentDetail;D=FAA-2014-0620-0004.

Comments

    We gave the public the opportunity to participate in developing
this AD. We considered the comment received. The commenter, an
anonymous individual, supported the NPRM (79 FR 52585, September 4,
2014).

Conclusion

    We reviewed the available data, including the comment received, and
determined that air safety and the public interest require adopting
this AD as proposed, except for minor editorial changes. We have
determined that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM (79 FR 52585, September 4, 2014) for correcting the unsafe
condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM (79 FR 52585, September 4, 2014).

Related Service Information Under 1 CFR Part 51

    We reviewed the following service bulletins:
     Airbus Service Bulletin A330-57-3096, Revision 5, dated
October 17, 2013.
     Airbus Service Bulletin A340-57-4104, Revision 4, dated
October 17, 2013.
     Airbus Service Bulletin A340-57-5009, Revision 3, dated
October 17, 2013.
    The service information describes procedures for detailed
inspections of the MLG rib 6 forward and aft lugs for cracking. This
service information is reasonably available; see ADDRESSES for ways to
access this service information.

Costs of Compliance

    We estimate that this AD affects 81 airplanes of U.S. registry.
    We estimate that it will take about 2 work-hours per product to
comply with the basic requirements of this AD. The average labor rate
is $85 per work hour. Required parts will cost about $0 per product.
Based on these figures, we estimate the cost of this AD on U.S.
operators to be $13,770, or $170 per product.
    We have no definitive data that would enable us to provide a cost
estimate for the on-condition actions specified in this AD.

Authority for This Rulemaking

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

Regulatory Findings

    We determined that this AD will not have federalism implications
under Executive Order 13132. This AD will not have a substantial direct
effect on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.
    For the reasons discussed above, I certify that this AD:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979);
    3. Will not affect intrastate aviation in Alaska; and
    4. 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.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov/#!docketDetail;D=FAA-2014-0620; 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 AD, the
regulatory evaluation, any comments received, and other information.
The street address for the Docket Operations office (telephone 800-647-
5527) is in the ADDRESSES section.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by removing Airworthiness Directive (AD)
2007-22-10, Amendment 39-15246 (72 FR 61796, November 1, 2007;
corrected November 16, 2007 (72 FR 64532)), and adding the following
new AD:

2015-03-06 Airbus: Amendment 39-18102, Docket No. FAA-2014-0620;
Directorate Identifier 2013-NM-238-AD.

(a) Effective Date

    This AD becomes effective March 25, 2015.

(b) Affected ADs

    This AD replaces AD 2007-22-10, Amendment 39-15246 (72 FR 61796,
November 1, 2007; corrected November 16, 2007 (72 FR 64532)).

(c) Applicability

    This AD applies to Airbus Model A330-201, -202, -203, -223, -
223F, -243, -243F, -301, -302, -303, -321, -322, -323, -341, -342,
and -343 airplanes; and Model A340-211, -212, -213 -311, -312, -313,
-541, and -642 airplanes; certificated in any category; all
manufacturer serial numbers.

(d) Subject

    Air Transport Association (ATA) of America Code 57, Wings.

(e) Reason

    This AD was prompted by reports of cracking of the main landing
gear (MLG) rib 6 aft bearing forward lug. We are issuing this AD to
detect and correct cracking of the MLG rib 6 aft bearing lugs, which
could result in collapse of the MLG upon landing.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Inspections

    Within 42 months since the airplane's first flight or since the
last MLG support rib replacement, as applicable; or within 4 months
after the effective date of this AD; whichever occurs later: Do a
detailed inspection for cracking of the left-hand and right-hand
wing MLG rib 6 aft bearing lugs (forward and aft), in accordance
with the Accomplishment Instructions of Airbus Service Bulletin
A330-57-3096, Revision 05, dated October 17, 2013; (for Model A330-
201, -202, -203, -223, -223F, -243, -243F, -301, -302, -303, -321, -
322, -323, -341, -342, and -343 airplanes); A340-57-4104, Revision
04, dated October 17, 2013 (for Model A340-211, -212, -213, -311, -
312, -313 airplanes); or A340-57-5009, Revision 03, dated October
17, 2013 (for Model A340-541 and -642 airplanes); as applicable.
Repeat the inspections at the times specified in paragraphs (g)(1)
through (g)(7) of this AD, as applicable.
    (1) For Model A330-201, -202, -203, -223, and -243 airplanes,
repeat the inspections at intervals not to exceed 300 flight cycles
or 1,500 flight hours, whichever occurs first.
    (2) For Model A330-223F and -243F airplanes, repeat the
inspections at intervals not to exceed 300 flight cycles or 900
flight hours, whichever occurs first.
    (3) For Model A330-301, -302, -303, -321, -322, -323, -341, -
342, and -343 airplanes, repeat the inspections at intervals not to
exceed 300 flight cycles or 900 flight hours, whichever occurs
first.
    (4) For Model A340-211, -212, and -213 airplanes, repeat the
inspections at intervals not to exceed 200 flight cycles or 800
flight hours, whichever occurs first.
    (5) For Model A340-311 and -312 airplanes; and Model A340-313
airplanes (except weight variant (WV) 27), repeat the inspections at
intervals not to exceed 200 flight cycles or 800 flight hours,
whichever occurs first.
    (6) For Model A340-313 (only WV27) airplanes, repeat the
inspections at intervals not to exceed 200 flight cycles or 400
flight hours, whichever occurs first.

    (7) For Model A340-541 and -642 airplanes, repeat the
inspections at intervals not to exceed 100 flight cycles or 500
flight hours, whichever occurs first.

(h) Corrective Action

    If any cracking is found during any inspection required by
paragraph (g) of this AD, before further flight, replace the cracked
MLG support rib using a method approved by the Manager,
International Branch, ANM-116, Transport Airplane Directorate, FAA;
or the European Aviation Safety Agency (EASA); or Airbus's EASA
Design Organization Approval (DOA). If approved by the DOA, the
approval must include the DOA-authorized signature. Replacement of
an MLG support rib does not terminate the repetitive inspections
required by paragraph (g) of this AD.

(i) Credit for Previous Actions

    This paragraph provides credit for the corresponding actions
required by paragraph (g) of this AD, if those actions were
performed before the effective date of this AD using the applicable
service bulletin identified in paragraphs (i)(1) through (i)(12) of
this AD.
    (1) Airbus Service Bulletin A330-57A3096, dated December 5,
2006, which was incorporated by reference in AD 2007-03-04,
Amendment 39-14915 (72 FR 4416, January 31, 2007), on February 15,
2007.
    (2) Airbus Service Bulletin A330-57A3096, Revision 01, dated
April 18, 2007, which is not incorporated by reference in this AD.
    (3) Airbus Service Bulletin A330-57-3096, excluding appendix 01,
Revision 02, dated August 13, 2007, which was incorporated by
reference in AD 2007-22-10, Amendment 39-15246 (72 FR 61796,
November 1, 2007; corrected November 16, 2007 (72 FR 64532)), on
November 16, 2007.
    (4) Airbus Service Bulletin A330-57-3096, Revision 03, dated
October 24, 2012, which is not incorporated by reference in this AD.
    (5) Airbus Service Bulletin A330-57-3096, Revision 04, dated
February 6, 2013, which is not incorporated by reference in this AD.
    (6) Airbus Service Bulletin A340-57A4104, dated December 5,
2006, which was incorporated by reference in AD 2007-03-04,
Amendment 39-14915 (72 FR 4416, January 31, 2007), on February 15,
2007.
    (7) Airbus Service Bulletin A340-57-4104, Revision 01, dated
August 13, 2007, which is not incorporated by reference in this AD.
    (8) Airbus Service Bulletin A340-57-4104, excluding appendix 01,
Revision 02, dated September 5, 2007, which was incorporated by
reference in AD 2007-22-10, Amendment 39-15246 (72 FR 61796,
November 1, 2007; corrected November 16, 2007 (72 FR 64532)), on
November 16, 2007.
    (9) Airbus Service Bulletin A340-57-4104, Revision 03, dated
October 24, 2012, which is not incorporated by reference in this AD.
    (10) Airbus Service Bulletin A340-57A5009, dated December 5,
2006, which was incorporated by reference in AD 2007-03-04,
Amendment 39-14915 (72 FR 4416, January 31, 2007), on February 15,
2007.
    (11) Airbus Service Bulletin A340-57-5009, excluding appendix
01, Revision 01, dated August 13, 2007, which was incorporated by
reference in AD 2007-22-10, Amendment 39-15246 (72 FR 61796,
November 1, 2007; corrected November 16, 2007 (72 FR 64532)), on
November 16, 2007.
    (12) Airbus Service Bulletin A340-57-5009, Revision 02, dated
October 24, 2012, which is not incorporated by reference in this AD.

(j) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
has the authority to approve AMOCs for this AD, if requested using
the procedures found in 14 CFR 39.19. In accordance with 14 CFR
39.19, send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the International Branch, send it to ATTN: Vladimir
Ulyanov, Aerospace Engineer, International Branch, ANM-116,
Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton,
WA 98057-3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>. Information
may be emailed to<EMAIL_ADDRESS>Before using any
approved AMOC, notify your appropriate principal inspector, or
lacking a principal inspector, the manager of the local flight
standards district office/certificate holding district office. The
AMOC approval letter must specifically reference this AD.
    (2) Contacting the Manufacturer: As of the effective date of
this AD, for any requirement in this AD to obtain corrective actions
from a manufacturer, the action must be accomplished using a method
approved by the Manager, International Branch, ANM-116, Transport
Airplane Directorate, FAA; or the European Aviation Safety Agency
(EASA); or Airbus's EASA Design Organization Approval (DOA). If
approved by the DOA, the approval must include the DOA-authorized
signature.

(k) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) EASA Airworthiness Directive 2013-0271, dated November 14,
2013, for related information. You may examine the MCAI in the AD
docket on the Internet at http://www.regulations.gov/#!documentDetail;D=FAA-2014-0620-0004.
    (2) Service information identified in this AD that is not
incorporated by reference is available at the addresses specified in
paragraphs (l)(3) and (l)(4) of this AD.

(l) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (i) Airbus Service Bulletin A330-57-3096, Revision 05, dated
October 17, 2013.
    (ii) Airbus Service Bulletin A340-57-4104, Revision 04, dated
October 17, 2013.
    (iii) Airbus Service Bulletin A340-57-5009, Revision 03, dated
October 17, 2013.
    (3) For service information identified in this AD, contact
Airbus SAS, Airworthiness Office--EAL, 1 Rond Point Maurice
Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96;
fax +33 5 61 93 45 80; email<EMAIL_ADDRESS>
Internet http://www.airbus.com.
    (4) You may view this service information at the FAA, Transport
Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For
information on the availability of this material at the FAA, call
425-227-1221.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Renton, Washington, on February 2, 2015.
Dionne Palermo,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2015-02672 Filed 2-17-15; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 76, Number 89 (Monday, May 9, 2011)]
[Notices]
[Pages 26787-26791]
[FR Doc No: 2011-11188]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-64383; File No. 4-627]

Short Sale Reporting Study Required by Dodd-Frank Act Section
417(a)(2)

AGENCY: Securities and Exchange Commission.

ACTION: Request for comment.

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

SUMMARY: The Securities and Exchange Commission (``Commission''), on
behalf of its Division of Risk, Strategy, and Financial Innovation
(``Division''), is requesting public comment with regard to studies
required by the Dodd-Frank Wall Street Reform and Consumer Protection
Act of the feasibility, benefits, and costs of requiring reporting in
real time, either publicly or, in the alternative, only to the
Commission and the Financial Industry Regulatory Authority (``FINRA''),
of short sale positions of publicly listed securities, and of
conducting a voluntary pilot program in which public companies would
agree to have all trades of their shares marked ``long,'' ``short,''
``market maker short,'' ``buy,'' or ``buy-to-cover,'' and reported as
such in real time through the Consolidated Tape.

DATES: Comments should be received on or before June 23, 2011.

ADDRESSES: Comments may be submitted by any of the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/other.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number 4-627 on the subject line.

Paper Comments

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

All submissions should refer to File Number 4-627. To help us 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). Comments will also 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. All comments received will be posted
without change; we do not edit personal identifying information from
submissions. You should submit only information that you wish to make
available publicly.

FOR FURTHER INFORMATION CONTACT: Amy Edwards, Assistant Director, Bruce
Kraus, Co-Chief Counsel, Lillian Hagen, Special Counsel, Sandra Mortal,
Financial Economist, Division of Risk, Strategy, and Financial
Innovation, at<PHONE_NUMBER>, Securities and Exchange Commission, 100
F Street, NE., Washington, DC 20549-4977.
    Discussion:
    Under Section 417(a)(2) of the Dodd-Frank Wall Street Reform and
Consumer Protection Act (the Dodd-Frank Act),\1\ the Commission's
Division of Risk, Strategy, and Financial Innovation is required to
conduct studies of the feasibility, benefits, and costs of (A)
requiring reporting in real time, publicly or, in the alternative, only
to the Commission and the Financial Industry Regulatory Authority,
short sale positions in publicly listed securities, and (B) conducting
a voluntary pilot program in which public companies could agree to have
sales of their shares marked ``long,'' ``short,'' or ``market maker
short,'' and purchases of their shares marked ``buy'' or ``buy-to-
cover,'' and reported as such in real time through the Consolidated
Tape.\2\
---------------------------------------------------------------------------

    \1\ Public Law 111-203 (July 21, 2010).
    \2\ The term ``Consolidated Tape,'' as used throughout this
release, refers to the current reporting systems for transactions in
all exchange-listed stocks and ETFs. These systems include Tapes A
and B of the Consolidated Tape Plan and Tape C of the Unlisted
Trading Privileges or ``UTP'' Plan. Trades in New York Stock
Exchange (``NYSE'')-listed securities are reported to Tape A; trades
in NYSE-Amex, NYSE-Arca, and regional exchange-listed securities are
reported to Tape B; and trades in NASDAQ-listed securities are
reported to Tape C. Transactions in unlisted equities, options, or
non-equity securities are not currently reported to the Consolidated
Tape. For more information see http://www.nyxdata.com/cta and http://www.utpplan.com/.
---------------------------------------------------------------------------

    In the Division's estimation, data made public by certain self-
regulatory organizations (``SROs'') indicate that orders marked
``short'' under current regulations account for nearly 50% of listed
equity share volume.\3\ Short

selling involves a sale of a security that the seller does not own or a
sale that is consummated by the delivery of a security borrowed by, or
for the account of, the seller.\4\ Typically, the short seller later
closes out the position by purchasing equivalent securities on the open
market and returning the security to the lender.\5\ In general, short
selling is used to profit from an expected downward price movement, to
provide liquidity in response to unanticipated demand, or to hedge the
risk of an economic long position in the same security or in a related
security.\6\
---------------------------------------------------------------------------

    \3\ This estimate was made by the Division based on short
selling volume data for June 2010 made available by SROs. This
estimate is consistent with estimates for prior months, and the
short percentage varied little from day to day. The underlying data
can be found at hyperlinks available at http://www.sec.gov/answers/shortsalevolume.htm, and have been provided since August 2009 by the
SROs listed therein. As indicated on these hyperlinks, ``short
selling volume'' is the volume of executed orders marked ``short''
or ``short exempt'' pursuant to Rule 200(g) of Regulation SHO (which
requires broker-dealers to mark all equity sell orders as either
``long,'' ``short,'' or ``short-exempt''). See 17 CFR 242.200(g).
Under current rules, these order marks are not submitted to or
reported on the Consolidated Tape, but are maintained as part of
broker-dealers' books and records pursuant to Rules 17a-3 and 17a-4.
See 17 CFR 240.17a-3(a)(5)-(7) and 240.17a-4(b)(8).
    \4\ See 17 CFR 242.200(a).
    \5\ See Exchange Act Release No. 50103 (July 28, 2004), 69 FR
48008 (Aug. 6, 2004) (``Regulation SHO Adopting Release''),
available at http://www.sec.gov/rules/final/34-50103.htm.
    \6\ See, e.g., id.
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    To better inform the study required by Section 417(a)(2) of the
Dodd-Frank Act, the Commission, on behalf of the Division, seeks
comment on both the existing uses of short selling in securities
markets and the adequacy or inadequacy of currently available
information regarding short sales, as well as comment on the likely
effect of these possible future reporting regimes on the securities
markets, including their feasibility, benefits, and costs.
    The Commission is required to submit a report on the results of
these studies to Congress no later than July 21, 2011. All interested
parties are invited to submit their views, in writing. Empirical
evidence relevant to any part of the Division's study is expressly
requested.

I. Baseline

    Certain information regarding short sales is currently available to
the public. This information includes the total ``short interest'' in
each listed security (i.e., total shares in short positions in that
security in all customer and proprietary firm accounts of FINRA member
firms), which has been reported twice each month since 2007,\7\ as well
as data made available more recently on the short selling volume for
each listed equity security that is reported on a daily basis,\8\ and
trade-by-trade short sale transaction data that is released on a
delayed (no more than 30 days after the end of the month) basis.\9\
Additionally, certain data vendors offer stock lending data, including
stock loan volume, lending costs, and the percentage of available stock
out on loan, which some market commentators have used as measures of
short selling.\10\ Further, Section 929X(a) of the Dodd-Frank Act
amended Section 13(f) of the Securities Exchange Act of 1934
(``Exchange Act'') to require the Commission to adopt rules requiring
monthly (or potentially more frequent) public short sale disclosures by
security, including the ``aggregate amount of the number of short sales
of each security, and any additional information determined by the
Commission.'' \11\
---------------------------------------------------------------------------

    \7\ See FINRA Rule 4560. FINRA member firms must report total
shares in short positions in all of their customer and proprietary
firm accounts in all equity securities twice per month through
FINRA's Web-based Regulation Filing Application (``RFA'') system.
The short interest data in listed stocks is released by exchanges
that list those stocks. Further, FINRA releases the short interest
data in unlisted stocks.
    \8\ See supra note 3 for more information on this data and how
to obtain it.
    \9\ These data sets include one observation for each execution
involving a short sale and typically date from August 2009. These
data sets can be found at hyperlinks available at http://www.sec.gov/answers/shortsalevolume.htm.
    \10\ Data Explorers and SunGard, for example, provide data on
securities lending to clients. As some commentators have noted,
stock lending facilitates short selling (see, e.g., Speech by
Chester Spatt, available at http://www.sec.gov/news/speech/2007/spch042007css.htm). As noted above, a number of data vendors sell
information as to shares that have been loaned to other investors.
Among other things, this information may include volume of loans,
lending costs, and the percentage of available stock out on loan.
This data offers indirect evidence of short selling, and some
research has used stock lending data as a proxy for actual short
sales. See, e.g., Oliver Wyman, ``The effects of short selling
public disclosure of individual positions on equity markets'' (Feb.
2011), available at http://www.oliverwyman.com/ow/pdf_files/OW_EN_FS_Publ_2011_Short_Selling_Public_Disclosure_Equity_Markets.pdf.
    \11\ See Exchange Act Section 13(f)(2), as amended.
---------------------------------------------------------------------------

    Q1. How are currently available data used by issuers, market
participants, and others (such as SROs, data vendors, media, analysts,
and academics) today? How widely distributed are currently available
data? Do costs or other factors limit access to currently available
data? Are there other important sources of information as to short
sales and short sale positions in addition to those mentioned above?
    Q2. The Division understands that equity market makers rely on
short selling to facilitate customer buy orders and to ensure that they
can maintain two-sided markets without carrying large risky positions.
The Division also understands that option market makers frequently sell
short to hedge positions taken in the course of market making
activities.\12\ Why else might market makers sell short? How much of
all short selling is accounted for by bona fide market making? Do
market makers sell short for purposes other than bona fide market
making? \13\ Are there ways in which short sales by market makers and
other market participants performing similar roles or functions (but
that are not subject to some or all of the requirements applicable to
market makers) could be viewed as problematic?
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    \12\ See, e.g., Exchange Act Release No. 58775 (Oct. 14, 2008),
73 FR 61690 (Oct. 17, 2008).
    \13\ In adopting Regulation SHO, the Commission discussed
several activities that are not bona fide market making.
Specifically, the Commission stated bona fide market making: (1)
``does not include activity that is related to speculative selling
strategies or investment purposes of the broker-dealer and is
disproportionate to the usual market making patterns or practices of
the broker-dealer in that security''; (2) ``where a market maker
posts continually at or near the best offer, but does not also post
at or near the best bid, the market maker's activities would not
generally qualify as bona fide market making for purposes of the
exception''; and (3) ``does not include transactions whereby a
market maker enters into an arrangement with another broker-dealer
or customer in an attempt to use the market maker's exception for
the purpose of avoiding compliance with Rule 203(b)(1) by the other
broker-dealer or customer.'' Exchange Act Release No. 50103, 69 FR
48008, 48015 (Aug. 6, 2004) (citations omitted).
---------------------------------------------------------------------------

    Q3. The Commission requests comment on the ways and the extent to
which, if any, commenters believe that short selling has been
associated with abusive market practices, such as ``bear raids'' where
an equity security is sold short in an effort to drive down the
security's price by creating an imbalance of sell-side interest? \14\
In addition, the Commission requests comment on the ways and extent to
which, if any, commenters believe trade-based manipulation (i.e.,
manipulating without a corporate action or spreading false information)
\15\ using short sales is possible? Would greater transparency of short
positions or short sale transactions help to better deter or prevent
such abuses, or assist in additional appropriate actions to prevent
them? If so, what new disclosures should be required?
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    \14\ See, e.g., Exchange Act Release No. 61595 (Feb. 26, 2010),
75 FR 11232, 11235 (Mar. 10, 2010).
    \15\ For a discussion of the theory regarding trade based
manipulation, See Allen, F. and D. Gale, ``Stock Price
Manipulation,'' (1992) Review of Financial Studies, 5(3), 503-529.
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II. Position Reporting

    Section 417(a)(2)(A) of the Dodd-Frank Act requires the Division to
conduct a study of short ``position''

reporting; the term ``position'' is not defined in the Exchange Act or
in Section 417 of the Dodd-Frank Act. For purposes of this study, the
Division plans to use ``position'' to refer to outstanding holdings at
a point in time. Further, Section 417 of the Dodd-Frank Act does not
specify a particular level of aggregation and netting, address whose
positions would be reported, or indicate whether derivatives or other
ways to obtain economic exposure to a stock are covered and existing
U.S. regulatory definitions vary in this dimension.\16\ ``Economic
exposure'' as used by the Division in this request for comment refers
to any financial interest in a company, however acquired. For example,
an investor may have economic exposure to a company by owning the stock
itself, or through ownership of an index or of derivatives. Likewise,
the short sale position reporting requirements in foreign
jurisdictions, implemented or proposed, differ from one another in a
number of areas with respect to the definition of ``position,''
including inclusion or exclusion of derivatives in the short interest
calculation, and reporting of net or gross position. For example, the
short interest calculation in Australia \17\ and Hong Kong \18\ does
not or would not include derivatives, whereas the U.K. \19\ and a
proposal by the European Union (the ``E.U. Proposal'') \20\ both
include or would include them. In Australia,\21\ the E.U. Proposal,\22\
and the U.K.,\23\ the reportable position is or would be the net short
position, while in Hong Kong, long interest and short positions are
calculated separately and are not netted.\24\
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    \16\ FINRA defines a short position as resulting from ``short
sales'' as that term is defined in Rule 200(a) of Regulation SHO,
but captures the position as of a settlement date as opposed to a
trading date. See FINRA Rule 4560. The Commission defined a short
selling position in former Rule 10a3-T as ``the aggregate gross
short sales of an issuer's Section 13(f) securities (excluding
options), less purchases to close out a short sale in the same
issuer,'' and stated that ``the Form SH short position is not net of
long position.'' See Exchange Act Release No. 58785 (Oct. 15, 2008),
73 FR 61678 (Oct. 17, 2008). The reporting requirements of Form SH
were in effect from September 22, 2008 to August 1, 2009.
    \17\ See Corporations Regulations 2001 (Commonwealth),
regulation 7.9.99(2) (Australia), indicating that the short interest
calculation includes securities, managed investment products, and
sovereign debentures, stocks or bonds.
    \18\ See Hong Kong Securities and Futures Commission,
Consultation Conclusions on Increasing Short Position Transparency
(Mar. 2, 2010), available at http://www.sfc.hk/sfc/doc/EN/speeches/consult/consultationconclusion2march2010english.pdf.
    \19\ Short Selling Rules, 2010, FINMAR 2010 (U.K.), ] 2.3.6.
    \20\ The Committee for European Securities Regulators (``CESR'')
proposed to require that positions be netted at the legal entity
level and include all financial instruments that create economic
exposure to an issue. See CESR, Model for a Pan-European Short
Selling Disclosure Regime, CESR/10-088 (Mar. 2010) (``E.U. Model''),
at 9.
    \21\ See Corporations Regulations 2001 regulation 7.9.99
(Australia), which states that ``a short position is short sales net
of long positions.''
    \22\ E.U. Model, at 9.
    \23\ FINMAR (U.K.), at ] 2.3.2.
    \24\ See Hong Kong Securities and Futures Commission,
Consultation Conclusions on Increasing Short Position Transparency
(Mar. 2, 2010), available at http://www.sfc.hk/sfc/doc/EN/speeches/consult/consultationconclusion2march2010english.pdf.
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    Q4. Would real time reporting of the short positions of all
investors, intermediaries, and market participants be feasible, and if
so, in what ways would it be beneficial? What problems would it
address? What would be any reasons, in terms of benefits and costs, for
treating short sale position reporting differently than long position
reporting? Would ``real time'' reporting be necessary to achieve these
benefits, or is ``prompt'' updating for material changes in the short
position (such as Schedule 13D updating requirements) sufficient? \25\
If real time reporting would be beneficial, should ``real time'' be
defined as ``continuously updated as soon as practicable,'' or as
frequent ``snapshots'' of short positions throughout the trading day?
Should ``as soon as practicable'' be defined and, if so, how? If
frequent short sale position reporting of some kind would be
beneficial, how frequently should such reports be made in order to
realize those benefits? Would real time data be more or less accurate
than data reported on a delay? Please explain why or why not.
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    \25\ Exchange Act Rule 13d-2 requires that if there is any
material change in the facts set forth in a Schedule 13D, including,
but not limited to, any material increase or decrease in the
percentage of the class beneficially owned, the person required to
file the statement must promptly file an amendment disclosing the
change. See 17 CFR 240.13d-2.
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    Q5. Who would be likely to use real time short position data, and
how? Would the short sale position data be too voluminous to be used
directly by investors? Could such data help to detect more easily,
better deter, or better prevent short selling abuses? Would market
commentators and others use real time short position data to help the
public better understand the U.S. securities markets? Would users of
real time short position data be able to derive reasonably clear
interpretations of the data in real time, and, to the extent they could
not, how would the costs and benefits of any reporting regime be
affected? Would real time data on short positions help or hinder long-
term investors in making ``efficient investments?''\26\
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    \26\ See, e.g., Biagio Bossone, Sandeep Mahajan, and Farah
Zahir, Financial Infrastructure, Group Interests, and Capital
Formation (International Monetary Fund, Working Paper 03/24, 2003),
available at http://www.imf.org/external/pubs/ft/wp/2003/wp0324.pdf.
Efficient investments optimize an investor's utility when trading
off expected return and risk. If investors can more accurately
estimate expected returns and risk, then they are better able to
make efficient investments. For a summary of the underlying theory,
see Bodie, Kane, and Marcus Investments, 7th ed. Chapters 8, 11, and
12.
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    Q6. How would real time data on short positions affect the behavior
of short sellers and other investors? Would it affect abusive short
selling, in particular? To what extent, if any, would such data deter
non-abusive short selling? For example, would such data reveal the
trading strategies of non-abusive short sellers? Could the availability
of such data create new opportunities for unfair or otherwise abusive
market practices, such as bear raids or short squeezes? Could real time
data on short positions lead to copycat trading? \27\ How would real
time data on short positions affect investor confidence?
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    \27\ Copycat trading is a form of ``herd behavior,'' which has
been described as ``[t]he tendency of investors, like herd animals,
to follow the group. Such conformity can give rise to bubbles in
individual securities and market sectors.'' Library of Congress,
Federal Research Division, Annotated Bibliography on the Behavioral
Characteristics of U.S. Investors (Aug. 2010), available at http://www.loc.gov/rr/frd/pdf-files/SEC_Annotated-Bibliography.pdf.
---------------------------------------------------------------------------

    Q7. How would real time data on short positions affect liquidity,
volatility, price efficiency, competition, and capital formation? Would
real time short position reporting affect equity-related securities
markets, such as option or other derivative markets, convertible bond
or other debt markets? If so, in what ways?
    Q8. How should ``position'' be defined to help ensure any short
sale position reports would be useful in detecting and deterring
abusive short sale practices? Should ``position'' be defined
differently to accomplish another purpose? If so, how, and what purpose
would such a definition help accomplish? Would there be a trade-off
between minimizing incremental implementation costs, above the cost of
existing short reporting systems and procedures, in the context of a
short position reporting regime and its utility? For maximum utility,
should short positions be reported gross, or net of long positions, or
in both ways? Should short positions include derivatives and index
components? Should short positions be the net economic exposure to a
stock across all instruments? Should short positions be defined as in
former Rule 10a3-T, in which ``the Form SH short position is

not net of long position?'' \28\ In the case of broker-dealers, should
position reporting be based on existing Regulation SHO aggregation
units within broker-dealers,\29\ for the broker-dealer taken as a
whole, or for its holding company? Please describe the feasibility of
any incremental changes to the existing short sale reporting systems
that would be necessary to report short sale ``positions.'' Would any
potential definitions of short positions be infeasible in real time?
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    \28\ See supra note 16.
    \29\ Rule 200(f) of Regulation SHO permits a broker-dealer,
under certain conditions, to calculate its long or short position by
independent trading-unit, rather than on a firm-wide basis. 17 CFR
242.200(f).
---------------------------------------------------------------------------

    Q9. What would be the benefits and costs of short position
reporting if ``position'' was defined to mean short interest,\30\ which
would be the aggregate number of shares short in each stock? Would real
time public reporting of aggregate short interest be feasible? If so,
what problems would it address, and how (and by whom) would this data
be used? Should the position reporting to be examined in the Division's
study be more comprehensive than the current bi-monthly short interest
reporting? For example, ``arranged financing'' (which would include
borrowing from a foreign bank or affiliate to cover short positions) is
not currently included in short interest. What would be the impact of
including arranged financing in a definition of short position?
---------------------------------------------------------------------------

    \30\ See supra note 7.
---------------------------------------------------------------------------

    Q10. What would be the feasibility, benefits, and costs of real
time short position reporting to regulators only, and not to the
public? What would the benefits and costs be if this real time
reporting information were to be made public on a delayed basis? What
length of delay might best balance any benefits and costs?
    Q11. Who would be in a position to report short positions in real
time? Would broker-dealers be able to accurately report customer short
positions in real time? Would anyone else be better suited? Would short
sellers themselves be equipped to report their own short positions in
real time? Would anyone but the short seller be in a position to report
the short seller's short position, whether or not the short position
was defined as the short seller's economic position including
derivatives? What would be the feasibility of adapting the technology
infrastructure that supports existing reporting requirements to support
real time short position reporting?
    Q12. Who would be in a position to collect and disseminate short
positions in real time? Would it be feasible for listing exchanges to
collect and disseminate this information? Would a consolidator be
better suited to collect this information? What would be the
feasibility of adapting the technology infrastructure supporting
existing reporting requirements to support real time short position
collection and dissemination? Would short position data developed from
existing systems be less meaningful than data from a new system
designed for this purpose? Why or why not?
    Q13. What would be the direct, quantifiable costs of short position
reporting for those compiling, reporting, collecting, or disseminating
the data? Please differentiate implementation costs from ongoing costs
and include opportunity costs. How feasible would it be for brokers,
exchanges, and others to create or modify a reporting and dissemination
system? What would be the particular technological challenges faced in
creating or modifying a reporting and dissemination system? Responses
based on the costs of implementing the 2007 modifications to short
interest reporting \31\ or the 2008 implementation of Form SH \32\ are
particularly requested.
---------------------------------------------------------------------------

    \31\ See supra note 7.
    \32\ This requirement was instituted via three emergency orders
(dated Sep. 18, 2008, Sep. 21, 2008, and Oct. 2, 2008), which
implemented Exchange Act Rule 10a-3T (See Exchange Act Release No.
58785 (Oct. 15, 2008), 73 FR 61678 (Oct. 17, 2008)). Comments are
available at http://www.sec.gov/comments/s7-31-08/s73108.shtml.
---------------------------------------------------------------------------

    Q14. How would the establishment of a significant reporting
threshold, which would limit short position reporting requirements to
holders of significant net short positions, affect costs and the
utility of the short position information? If reporting thresholds
would be useful, would thresholds at the 5% level used under Section
13(g) of the Exchange Act or the 0.25% level used in former Form SH
\33\ be appropriate, or would a lower threshold, such as that used in
the U.K. model, be preferable? \34\ Or would a higher threshold be
appropriate? Please explain why or why not. Would thresholds (computed
on a net basis) at U.K. levels (or the lower levels being contemplated
by the E.U.) \35\ capture ordinary course, bona fide market maker
positions, or would they tend generally to capture only the positions
of investors taking a view as to the stock's future price direction?
Would a general exemption from position reporting (or public position
reporting) for market makers be appropriate? Why or why not?
---------------------------------------------------------------------------

    \33\ Certain institutional investment managers were required to
report short sales of certain securities on former Form SH unless
the short position constituted less than 0.25% of the class of
shares and had a fair market value of less than $10,000,000. See
Exchange Act Release No. 58785 (Oct. 15, 2008), 73 FR 61678 (Oct.
17, 2008).
    \34\ Two types of short positions must be publicly disclosed in
the U.K. A net short position of 0.25% and above of issued capital
in a U.K. company involved in a rights issue must be disclosed. In
addition, a net short position in a U.K. financial sector company
must be disclosed initially when such interest exceeds 0.25% of
total share capital, and on an ongoing basis when the position
exceeds or falls below 0.25%, 0.35%, 0.45% and 0.55% and each 0.1%
threshold thereafter. See FINMAR Sec. Sec.  2.2.1, 2.1.2. See also
U.K. Financial Services Authority, ``Implementing Aspects of the
Financial Services Act 2010'' (2010), at 2.13.
    \35\ The E.U. Model would require reporting to regulators when
short interest exceeds 0.2% of issued share capital, and reporting
to the public when it exceeds 0.5% of issued share capital. See E.U.
Model, at 8-9.
---------------------------------------------------------------------------

    Q15. How should experiences with short sale position reporting
regimes in foreign jurisdictions \36\ inform the analysis of
feasibility, benefits, and costs? How relevant are any analyses of
other reporting regimes to the Division's study? \37\ The Commission
requests information on any relevant studies not cited in this request
for comment.
---------------------------------------------------------------------------

    \36\ See supra notes 17-24, 34, and 35 for examples.
    \37\ See Oliver Wyman Report, supra note 10, and also U.K.
Financial Services Authority, Short selling: Feedback on DP09/1, 09/
4 (Oct. 2009), available at http://www.fsa.gov.uk/pubs/discussion/fs09_04.pdf; European Commission, Impact Assessment on the Proposal
for a Regulation of the European Parliament and of the Council on
Short Selling and Certain Aspects of Credit Default Swaps, SEC(2010)
1055 (Sep. 15, 2010), available at http://ec.europa.eu/internal_market/securities/docs/short_selling/20100915_impact_assessment_en.pdf.
---------------------------------------------------------------------------

 III. Transaction Reporting

    The Commission requests comment, on behalf of the Division, on the
feasibility, benefits, and costs of the Consolidated Tape collecting
and disseminating certain transaction marks. Specifically, Section
417(a)(2)(B) of the Dodd-Frank Act requires the Division to study the
feasibility, benefits, and costs of conducting a voluntary pilot
program in which public companies would agree to have all trades of
their shares marked ``long,'' ``short,'' and/or ``market maker short''
(for the sell portion(s) of the trade), and ``buy'' and/or ``buy to
cover'' (for the buy portion(s) of the trade) and reported in real time
through the Consolidated Tape.
    Q16. What benefits, costs, or unintended consequences would flow
from adding these transaction marks to the Consolidated Tape? Who would
use these marks, and how? Would data from the Consolidated Tape be
accessible to the market participants who are most interested in short
selling information? Would the Consolidated Tape data be too voluminous
to be used directly by

interested market participants? How would the Consolidated Tape marks
affect the behavior of short sellers and other investors? Would
Consolidated Tape marks help or hinder long-term investors in making
``efficient investments?'' \38\ Would market commentators and others
use Consolidated Tape marks to help the public better understand
markets? Could such marks help to better detect, deter, or prevent
identified short selling abuses? Alternatively, could such marks
themselves present opportunities for alleged unfair or otherwise
abusive market practices, such as bear raids or short squeezes? Would
real time Consolidated Tape marks lead to copycat trading? How would
Consolidated Tape marks affect investor confidence?
---------------------------------------------------------------------------

    \38\ See supra note 26.
---------------------------------------------------------------------------

    Q17. Please discuss the feasibility, benefits, and costs related to
the ``short sale,'' ``market maker short,'' and ``buy-to-cover'' marks
specifically, and the effects of any choices that would be made when
defining such terms. Would there be a trade-off between defining the
trades that would be subject to these marks for maximum utility and
accuracy to investors, and minimizing implementation costs by building
on existing definitions and order marking infrastructure? \39\ If so,
how should the tension between these goals be best resolved? Would
there be any other potential issues associated with the accuracy or
clarity of Consolidated Tape marks? Would the Consolidated Tape marks
present possibilities for misinterpretation of the data that could
impact any benefits and costs?
---------------------------------------------------------------------------

    \39\ See supra note 3.
---------------------------------------------------------------------------

    Q18. How would any additions to Consolidated Tape marks affect
liquidity, volatility, price efficiency, competition, and capital
formation? To what extent, if any, would such data deter short selling
activity not associated with abusive market practices, but that
enhances market quality, for example, by revealing trading strategies?
What are the consequences of such deterrence? Would any additions to
Consolidated Tape marks have consequences (including benefits or costs)
for equity-related securities markets, such as options or other
derivative markets, convertible bond or other debt markets? If so,
please explain. What would the feasibility, benefits, and costs be if
this real time reporting information were to be made public on a
delayed basis? What length of delay might best balance any benefits and
costs?
    Q19. What would be the direct, quantifiable costs of adding the
additional fields to the Consolidated Tape to support new marks? Please
differentiate implementation costs from ongoing costs and include
opportunity costs. How feasible would it be for brokers, exchanges, and
others to modify order management systems, or other systems, for these
marks? What would be the potential technological challenges faced in
implementing these marks? Would the Consolidated Tape bear significant
implementation or ongoing costs? For example, would capacity
requirements be significantly higher? Would vendors and others who
receive feeds from the Consolidated Tape bear significant
implementation or ongoing costs? Responses based on the costs of
implementing Regulation SHO Rule 201,\40\ Regulation NMS,\41\ and Form
SH \42\ are particularly requested.
---------------------------------------------------------------------------

    \40\ 17 CFR 242.201.
    \41\ 17 CFR 242.600 et seq.
    \42\ See supra note 33.
---------------------------------------------------------------------------

    Q20. What would be the benefits and costs (including the direct,
quantifiable costs) of conducting a pilot for the Consolidated Tape
marking? Would a pilot for Consolidated Tape marking be feasible? Would
the direct, quantifiable costs of implementing and maintaining a pilot
be any less, or more, than those of implementing and maintaining
Consolidated Tape marking on all listed issuers? Would market
participants be likely to behave differently during a pilot, for
example by hesitating to develop new trading strategies? \43\
---------------------------------------------------------------------------

    \43\ For example, in 2004, the Commission adopted Rule 202T,
which provided for the temporary suspension of the short sale uptick
rule in certain securities so that the Commission could study
trading behavior in the absence of a price test. See Exchange Act
Release No. 50103 (July 28, 2004), 69 FR 48008 (Aug. 6, 2004). In
the view of Division Staff, Boehmer, Jones, and Zhang provide
evidence suggesting that trading behavior may not have completely
adjusted to the Regulation SHO Pilot. See Boehmer, Jones, and Zhang,
``Unshackling Short Sellers: The Repeal of the Uptick Rule'' (2008),
available at http://www.gsb.columbia.edu/mygsb/faculty/research/pubfiles/3231/UptickRepealDec11.pdf.
---------------------------------------------------------------------------

    Q21. What would be the benefits and costs of the voluntary
component of the pilot? What types of issuers would likely volunteer to
participate in a pilot? How would this self-selection affect the
usefulness of any data derived from a pilot? Are there other
consequences from a voluntary pilot? To maximize the utility of any
pilot, should the pilot be designed to limit participation in a way
that facilitates comparisons of trading in pilot companies and trading
in non-pilot companies? If participation should be limited, how should
the Commission determine which volunteers to include or exclude from
the pilot?
    Q22. How should experiences with transaction marking regimes in
foreign jurisdictions \44\ inform analysis of the feasibility,
benefits, and costs? Are there any analyses of transaction marking
regimes that are relevant to the Division's study?
---------------------------------------------------------------------------

    \44\ Several foreign jurisdictions have short sale marking
requirements in place including Australia (Australian Securities and
Investment Commission, Regulatory Guide, RG 196.12 (April 2010)),
Canada (Universal Market Integrity Rules, Rule 3.2), Hong Kong (Hong
Kong Exchange Rules, Eleventh Schedule, Rule 5), and Japan (Japan
Financial Services Agency, ``FSA Extends Temporary Measures
Regarding Restrictions on Short Selling and Purchases of Own Stocks
by Listed Companies'' (Jan. 21, 2011) (effective until Apr. 30,
2011)).
---------------------------------------------------------------------------

    Q23. To what extent would Consolidated Tape marks be a substitute
or compliment to real time short position reporting? How would the
benefits and costs of any Consolidated Tape marks be impacted if real
time position reporting existed and vice versa?

    Dated: May 3, 2011.

    By the Commission.
Elizabeth M. Murphy,
Secretary.
[FR Doc. 2011-11188 Filed 5-6-11; 8:45 am]
BILLING CODE 8011-01-P


From: Purdy, Angeline Sent: Wednesday, January 07, 2004 2: 28 PM To: [ service list for all parties in State of New York v. EPA, No. 03  1380 ( DC Cir).]

Subject: State of New York et al. vs. EPA: response to inquiries regarding " FIP Rule."

We have received questions about how the D. C. Circuit's December 24, 2003 stay of the October 27, 2003 Equipment Replacement Rule impacts the December 24, 2003 final rule updating the incorporation of 40 C. F. R. º 52.21 into the federal portions of those SIPs without approved PSD programs. See 68 Fed. Reg. 74483 (" FIP Rule"). The FIP Rule itself was not stayed, and thus, all the sections of part 52 which incorporate º 52.21 have been updated. See, e. g., 40 C. F. R. º 52.499 ( D. C. SIP). Nonetheless, because the FIPs incorporate sections of 52.21 that have been stayed by the court, these " ERP" sections are not effective in the areas covered by the FIPs ( e. g., it does not matter that the FIPs now incorporate 52.21( cc) because that section is stayed). It is EPA's opinion that this result occurs automatically due to the Court's staying of the underlying rule changes at 40 C. F. R. º 52.21, and that further action by the Court or EPA is not necessary. **************************************** Angeline Purdy U. S. Department of Justice Environmental Defense Section P. O. Box 23986 Washington, D. C. 20026 ( 202) 514 0996 angeline. purdy@ usdoj. gov **************************************** This e mail, including attachments, is intended only for the use of the individual( s) to whom it is addressed. It may contain information that is privileged attorney client communications or work product, confidential or otherwise protected from disclosure under applicable law.


[Federal Register Volume 79, Number 87 (Tuesday, May 6, 2014)]
[Rules and Regulations]
[Page 25681]
[FR Doc No: 2014-10265]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2014-0317]

Drawbridge Operation Regulation; Hackensack River, Jersey City,
NJ

AGENCY: Coast Guard, DHS.

ACTION: Notice of deviation from drawbridge regulation.

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SUMMARY: The Coast Guard has issued a temporary deviation from the
operating schedule that governs the Witt-Penn (Rt-7) Bridge across the
Hackensack River at mile 3.1, at Jersey City, New Jersey. The deviation
is necessary to facilitate replacement of the safety barrier gates at
the bridge. This temporary deviation authorizes the bridge to remain in
the closed position for five days.

DATES: This deviation is effective from June 9, 2014 through June 13,
2014.

ADDRESSES: The docket for this deviation, USCG-2014-0317 is available
at http://www.regulations.gov. Type the docket number in the ``SEARCH''
box and click ``SEARCH''. Click on Open Docket Folder on the line
associated with this deviation. You may also visit the Docket
Management Facility in Room W12-140 on the ground floor of the
Department of Transportation West Building, 1200 New Jersey Avenue SE.,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary deviation, call or email Mr. Joe Arca, Project Officer, First
Coast Guard District, telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>If you have questions on viewing the docket, call
Cheryl Collins, Program Manager, Docket Operations, telephone 202-366-
9826.

SUPPLEMENTARY INFORMATION: The Witt-Penn (Rt-7) Bridge across the
Hackensack River at mile 3.1, at Jersey City, has a vertical clearance
in the closed position of 35 feet at mean high water and 40 feet at
mean low water. The existing drawbridge operation regulations are
listed at 33 CFR 117.723. The waterway users are seasonal recreational
vessels and commercial vessels of various sizes.
    The owner of the bridge, New Jersey Department of Transportation,
requested a temporary deviation from the operating schedule to
facilitate replacement of the safety barrier gates at the bridge.
    Under this temporary deviation the Witt-Penn (Rt-7) Bridge may
remain in the closed position for five days from June 9, 2014 through
June 13, 2014. There are no alternate routes for vessel traffic. The
bridge could be opened in an emergency situation.
    The Coast Guard will also inform the users of the waterways through
our Local and Broadcast Notice to Mariners of the change in operating
schedule for the bridge so that vessels can arrange their transits to
minimize any impact caused by the temporary deviation.
    In accordance with 33 CFR 117.35(e), the drawbridge must return to
its regular operating schedule immediately at the end of the effective
period of this temporary deviation. This deviation from the operating
regulations is authorized under 33 CFR 117.35.

    Dated: April 24, 2014.
C.J. Bisignano,
Supervisory Bridge Management Specialist, First Coast Guard District.
[FR Doc. 2014-10265 Filed 5-5-14; 8:45 am]
BILLING CODE 9110-04-P