[Federal Register Volume 76, Number 120 (Wednesday, June 22, 2011)]
[Rules and Regulations]
[Pages 36283-36285]
[FR Doc No: 2011-15368]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2011-0259; Directorate Identifier 2010-NM-196-AD;
Amendment 39-16730; AD 2011-13-07]
RIN 2120-AA64

Airworthiness Directives; Dassault Aviation Model FALCON 7X
Airplanes

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

ACTION: Final rule.

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SUMMARY: We are superseding an existing airworthiness directive (AD)
that applies to the products listed above. This AD results from
mandatory continuing airworthiness information (MCAI) originated by an
aviation authority of another country to identify and correct an unsafe
condition on an aviation product. The MCAI describes the unsafe
condition as:

    Several occurrences of untimely radio-altimeter lock-up have
been reported, where the failed radio-altimeter indicated a negative
distance to the ground despite the aircraft was flying at medium or
high altitude.
    A locked radio-altimeter 1 leads to untimely inhibition
of warnings that could be displayed along with certain abnormal
conditions while the avionic system switches into landing mode
during altitude cruise.
* * * * *
    [Untimely radio altimeter lock-up] may cause the crew to be
unaware of possible system failures that could require urgent crew's
actions.
* * * * *

We are issuing this AD to require actions to correct the unsafe
condition on these products.

DATES: This AD becomes effective July 27, 2011.

ADDRESSES: You may examine the AD docket on the Internet at http://

www.regulations.gov or in person at the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC.

FOR FURTHER INFORMATION CONTACT: Tom Rodriguez, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone (425)
227-1137; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to include an AD that would apply to the specified products.
That NPRM was published in the Federal Register on March 29, 2011 (76
FR 17364), and proposed to supersede AD 2010-02-02, Amendment 39-16173
(75 FR 1697, January 13, 2010). That NPRM proposed to correct an unsafe
condition for the specified products. The MCAI states:

    Several occurrences of untimely radio-altimeter lock-up have
been reported, where the failed radio-altimeter indicated a negative
distance to the ground despite the aircraft was flying at medium or
high altitude.
    A locked radio-altimeter 1 leads to untimely inhibition
of warnings that could be displayed along with certain abnormal
conditions while the avionic system switches into landing mode
during altitude cruise.
* * * * *
    [Untimely radio altimeter lock-up] may cause the crew to be
unaware of possible system failures that could require urgent crew's
actions.
    To address this unsafe condition, [EASA] AD 2009-0208 was issued
on 13 October 2009 [which corresponds with FAA AD 2010-02-02]. It
mandated application of a new abnormal Airplane Flight Manual (AFM)
procedure when radio-altimeter 1 lock-up occurs and
prohibited dispatch of the aeroplane with any radio-altimeter
inoperative.
    Since AD 2009-0208 was issued, Easy avionics load 10 has been
developed with change M0566 or Service Bulletin (SB) Falcon 7X
n[deg]100 that brings new features to display a ``RA miscompare''
flag on both Primary Display Units (PDU) and accepts a commanded
system reversion to the correct radio-altimeter output.
    EASA AD 2009-0208R1 is issued to allow not deactivating radio-
altimeter 1 in case lock-up conditions occur in flight for
aeroplanes on which M0566 or SB Falcon 7X n[deg]100 has been
embodied.

You may obtain further information by examining the MCAI in the AD
docket.

Comments

    We gave the public the opportunity to participate in developing
this AD. We received no comments on the NPRM or on the determination of
the cost to the public.

Conclusion

    We reviewed the available data and determined that air safety and
the public interest require adopting the AD as proposed.

Differences Between This AD and the MCAI or Service Information

    We have reviewed the MCAI and related service information and, in
general, agree with their substance. But we might have found it
necessary to use different words from those in the MCAI to ensure the
AD is clear for U.S. operators and is enforceable. In making these
changes, we do not intend to differ substantively from the information
provided in the MCAI and related service information.
    We might also have required different actions in this AD from those
in the MCAI in order to follow our FAA policies. Any such differences
are highlighted in a Note within the AD.

Costs of Compliance

    We estimate that this AD will affect about 24 products of U.S.
registry.
    The actions that are required by AD 2010-02-02 and retained in this
AD take about 1 work-hour per product, at an average labor rate of $85
per work-hour. Based on these figures, the estimated cost of the
currently required actions is $85 per product.
    We estimate that it will take about 1 work-hour per product to
comply with the new basic requirements of this AD. The average labor
rate is $85 per work-hour. Based on these figures, we estimate the cost
of this AD to the U.S. operators to be $2,040, or $85 per product.

Authority for This Rulemaking

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

Regulatory Findings

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

Examining the AD Docket

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

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 Amendment 39-16173 (75 FR
1697, January 13, 2010) and adding the following new AD:

2011-13-07 Dassault Aviation: Amendment 39-16730. Docket No. FAA-
2011-0259; Directorate Identifier 2010-NM-196-AD.

Effective Date

    (a) This airworthiness directive (AD) becomes effective July 27,
2011.

Affected ADs

    (b) This AD supersedes AD 2010-02-02, Amendment 39-16173.

Applicability

    (c) This AD applies to Dassault Aviation Model FALCON 7X
airplanes, certificated in any category, all serial numbers.

Subject

    (d) Air Transport Association (ATA) of America Code 34:
Navigation.

Reason

    (e) The mandatory continuing airworthiness information (MCAI)
states:

    Several occurrences of untimely radio-altimeter lock-up have
been reported, where the failed radio-altimeter indicated a negative
distance to the ground despite the aircraft was flying at medium or
high altitude.
    A locked radio-altimeter 1 leads to untimely inhibition
of warnings that could be displayed along with certain abnormal
conditions while the avionic system switches into landing mode
during altitude cruise.
* * * * *
    [Untimely radio altimeter lock-up] may cause the crew to be
unaware of possible system failures that could require urgent crew's
actions.
* * * * *

Compliance

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

Restatement of Requirements of AD 2010-02-02, With Revised Affected
Airplanes

    (g) For airplanes on which modification M0566 or Dassault
Service Bulletin Falcon 7X-100 has not been accomplished: Within 14
days after January 28, 2010 (the effective date of AD 2010-02-02),
revise the Limitations Section of the Dassault Falcon 7X Airplane
Flight Manual (AFM) to include the following statement. This may be
done by inserting a copy of this AD in the AFM.
    ``If radio-altimeter 1 lock-up conditions occur in
flight, power off radio-altimeter 1, in accordance with the
instructions of Falcon 7X AFM procedure 3-140-65.
    Dispatch of the airplane with any radio-altimeter inoperative is
prohibited.''

    Note 1:  When a statement identical to that in paragraph (g) of
this AD has been included in the general revisions of the AFM, the
general revisions may be inserted into the AFM, and the copy of this
AD may be removed from the AFM.

New Requirements of This AD

    (h) For airplanes on which M0566 or Dassault Service Bulletin
Falcon 7X-100 has been accomplished: Within 14 days after the
effective date of this AD, revise the Limitations Section of the
Dassault Falcon 7X AFM to include the following statement. This may
be done by inserting a copy of this AD in the AFM. Doing this
revision terminates the requirements of paragraph (g) of this AD.
    ``If radio-altimeter 1 lock-up conditions occur in
flight, revert to the correct radio-altimeter output, in accordance
with the instructions of Falcon 7X AFM procedure 3-140-65B and 3-
140-70A.
    Dispatch of the airplane with any radio-altimeter inoperative is
prohibited.''

    Note 2:  When a statement identical to that in paragraph (h) of
this AD has been included in the general revisions of the AFM, the
general revisions may be inserted into the AFM, and the copy of this
AD may be removed from the AFM.

FAA AD Differences

    Note 3:  This AD differs from the MCAI and/or service
information as follows: No differences.

Other FAA AD Provisions

    (i) 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: Tom
Rodriguez, Aerospace Engineer, International Branch, ANM-116,
Transport Airplane Directorate, FAA, 1601 Lind Avenue, SW., Renton,
Washington 98057-3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.
Information may be e-mailed 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) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.

Related Information

    (j) Refer to MCAI European Aviation Safety Agency (EASA)
Airworthiness Directive 2009-0208R1, dated June 2, 2010, for related
information.

Material Incorporated by Reference

    (k) None.

    Issued in Renton, Washington, on June 14, 2011.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2011-15368 Filed 6-21-11; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 83, Number 20 (Tuesday, January 30, 2018)]
[Notices]
[Pages 4324-4327]
[FR Doc No: 2018-01676]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-82576; File No. SR-OCC-2018-001]

Self-Regulatory Organizations; The Options Clearing Corporation;
Notice of Filing of Proposed Rule Change Related to The Options
Clearing Corporation's Fee Policy

January 24, 2018.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on January 18, 2018, The Options Clearing Corporation (``OCC'') filed
with the Securities and Exchange Commission (``Commission'') the
proposed rule change as described in Items I, II, and III below, which
Items have been prepared by OCC. The Commission is publishing this
notice to solicit comments on the proposed rule change from interested
persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b\4.
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I. Clearing Agency's Statement of the Terms of Substance of the
Proposed Rule Change

    The proposed rule change by OCC would make certain revisions to
OCC's Fee Policy to reduce the permitted implementation time for
proposed changes to its Schedule of Fees. Under the proposed rule
change, the Fee Policy would provide that any change to the Schedule of
Fees resulting from a review of OCC's fees by the Board of Directors
(``Board'') as stipulated under the Fee Policy would be implemented no
sooner than 30 days from the date of the filing of the proposed fee
change with the Commission, rather than the minimum 60-day period
provided for currently in the Fee Policy.
    The Fee Policy is included as confidential Exhibit 5 to the filing.
Material proposed to be added to the Fee Policy as currently in effect
is marked by underlining and material proposed to be deleted is marked
in strikethrough text. All terms with initial capitalization that are
not otherwise defined herein have the same meaning as set forth in the
By-Laws and Rules.\3\
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    \3\ OCC's By-Laws and Rules can be found on OCC's public
website: http://optionsclearing.com/about/publications/bylaws.jsp.
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II. Clearing Agency's Statement of the Purpose of, and Statutory Basis
for the Proposed Rule Change

    In its filing with the Commission, OCC included statements
concerning the purpose of and basis for the

proposed rule change and discussed any comments it received on the
proposed rule change. The text of these statements may be examined at
the places specified in Item IV below. OCC has prepared summaries, set
forth in sections (A), (B), and (C) below, of the most significant
aspects of these statements.

(A) Clearing Agency's Statement of the Purpose of, and Statutory Basis
for, the Proposed Rule Change

(1) Purpose
    The purpose of this proposed rule change is to amend OCC's Fee
Policy \4\ to provide that any change to OCC's Schedule of Fees
resulting from a review of OCC's fees by the Board as stipulated under
the Fee Policy \5\ would be implemented no sooner than 30 days
following the filing of the revised Schedule of Fees as a proposed rule
change with the Commission, rather than no sooner than 60 days after
filing. Under Section 19(b)(3)(A)(ii) of the Securities Exchange Act of
1934, as amended (``Act''),\6\ a proposed rule change takes effect upon
filing with the Commission if it is designated by OCC as establishing
or changing a due, fee or other charge on any person. This proposed
rule change, however, specifically concerns the time frame in which OCC
permits itself to implement any proposed fee change under its Fee
Policy.
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    \4\ OCC's Fee Policy was adopted as part of OCC's plan for
raising additional capital (``Capital Plan''), which was put in
place in light of proposed regulatory capital requirements
applicable to systemically important financial market utilities,
such as OCC. See Exchange Act Release No. 34-74452 (March 6, 2015),
80 FR 13058 (March 12, 2015) (SR-OCC-2015-02); Exchange Act Release
No. 34-74387 (February 26, 2015), 80 FR 12215 (March 6, 2015) (SR-
OCC-2014-813) (``Approval Orders''). BATS Global Markets, Inc., BOX
Options Exchange LLC, KCG Holdings, Inc., Miami International
Securities Exchange, LLC, and Susquehanna International Group, LLP
each filed petitions for review of the Approval Order, challenging
the action taken by delegated authority. Following review of these
petitions, on August 8, 2017, the U.S. Court of Appeals for the DC
Circuit remanded the Approval Orders to the Commission to further
analyze whether the Capital Plan is consistent with the Securities
Exchange Act of 1934. Susquehanna Int'l Grp., LLP v. SEC, 866 F.3d
442 (DC Cir. 2017). While the Commission further analyzes the
Capital Plan, it remains in effect as originally approved by the
Commission. See id.
    \5\ OCC notes that authority to review and approve changes to
OCC's fees pursuant to the Capital Plan has been delegated to the
Compensation and Performance Committee of the Board. See OCC
Compensation and Performance Committee Charter, available at: http://www.optionsclearing.com/components/docs/about/corporate-information/performance_committee_charter.pdf.
    \6\ See 15 U.S.C. 78s(b)(3)(A)(ii). Regarding any such proposed
rule change that becomes immediately effective, however, the
Commission also has certain conditional authority to summarily
temporarily suspend the change and institute proceedings to
determine whether to approve or disapprove it. See 15 U.S.C.
78s(b)(3)(C).
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    In General, Article IX, Section 9 of OCC's By-Laws requires that
OCC's fee structure be designed to: (1) Cover OCC's operating expenses
plus a business risk buffer; (2) maintain reserves deemed reasonably
necessary by OCC's Board; and (3) accumulate an additional surplus
deemed advisable by the Board to permit OCC to meet its obligations to
its Clearing Members and the public.\7\ In connection with these
requirements, OCC has adopted a Fee Policy under which the Board
determines OCC's fee structure. As part of the Fee Policy, the Board
reviews the existing Schedule of Fees on a quarterly basis to determine
its appropriateness. Central to the Board's determination of the
appropriate level of fees is the requirement to cover OCC's operating
expenses plus an additional amount referred to as a ``Business Risk
Buffer.'' The Business Risk Buffer is an amount of fee revenue that OCC
targets above its anticipated operating expenses to allow for
unexpected fluctuations in operating expenses, business capital needs,
and regulatory capital requirements. Under the Fee Policy, OCC
generally sets clearing fees at a level designed to cover operating
expenses plus a Business Risk Buffer of 25%. In determining the proper
level of fees to achieve this goal, the Board may rely on a
recommendation of OCC staff that is based on an analysis of, among
other things, year-to-date revenue and operating expenses and projected
clearing volume and operating expenses.
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    \7\ OCC notes that clauses two and three above would be invoked
only at the discretion of OCC's Board and in extraordinary
circumstances.
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    OCC believes that the current 60-day implementation period under
the Fee Policy (i) increases the difficulty of projecting appropriate
fee levels needed to cover OCC's operating expenses plus the Business
Risk Buffer given the amount of time that passes between OCC's analysis
and the implementation of the fee change, (ii) increases the risk that
by the time the fee change is implemented, the extended delay in
implementation may result in revenues that diverge further from the
target the Business Risk Buffer (either higher or lower), and (iii)
increases the impact of a fee change due to the delayed implementation
timing.\8\ As a result, OCC may need to make more frequent and/or more
dramatic changes to its Schedule of Fees in order to maintain its
target Business Risk Buffer, resulting in less stability in fees for
OCC's participants. OCC believes that reducing the 60-day
implementation period to 30 days would allow for fee adjustments that
are based on revenue and expense data that is more current, and
therefore projections that are more accurate. OCC believes the proposed
rule change would therefore improve its ability to set fees at an
appropriate level to meet its requirements under the Capital Plan while
still providing adequate notice to its participants of any proposed fee
changes.
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    \8\ OCC notes that, as a practical matter, it typically
implements changes to its Schedule of Fees on the first of the
month. As a result, the actual delay in implementing a proposed fee
change may be significantly longer than 60 days depending on the
timing of Board approval of any fee change and subsequent filing of
the associated proposed rule change.
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(2) Statutory Basis
    Section 17A(b)(3)(D) of the Act \9\ requires that the rules of a
clearing agency provide for the equitable allocation of reasonable
dues, fees, and other charges among its participants. In addition, Rule
17Ad-22(e)(21) \10\ requires that a covered clearing agency establish,
implement, maintain and enforce written policies and procedures
reasonably designed to be efficient and effective in meeting the
requirements of its participants and the markets it serves. OCC
believes the proposed rule change is consistent with Section
17A(b)(3)(D) of the Act \11\ and the rules thereunder because allowing
earlier implementation of changes to OCC's Schedule of Fees would
ensure that the fees charged to Clearing Members are based on based on
revenue and expense data that is more current, and therefore
projections that are more accurate. As a result, OCC believes it would
be able to implement fee changes that are more accurately calibrated to
meet the requirements of its Fee Policy and Capital Plan, which in turn
would foster the equitable allocation of reasonable dues, fees and
other charges among Clearing Members. OCC also believes that the
proposed rule change is consistent with Rule 17Ad-22(e)(21) \12\
because the shortened implementation period would improve OCC's ability
to implement a Schedule of Fees that is based on revenue and expense
data that is more current and indicative of OCC's business, and
therefore, the change would enhance OCC's ability to be cost-effective
in meeting the requirements of its Clearing Members.
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    \9\ 15 U.S.C. 78q-1(b)(3)(D).
    \10\ 17 CFR 240.17Ad-22(e)(21).
    \11\ 15 U.S.C. 78q-1(b)(3)(D).
    \12\ 17 CFR 240.17Ad-22(e)(21).

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(B) Clearing Agency's Statement on Burden on Competition

    Section 17A(b)(3)(I) of the Act \13\ requires that the rules of a
clearing agency not impose any burden on competition not necessary or
appropriate in furtherance of the Act. OCC believes that the proposed
rule change would not have any impact or impose a burden on
competition. The proposed changes to the Fee Policy would not
disadvantage or favor any particular user in relationship to another
user because the potential for earlier implementation of changes to the
Schedule of Fees would apply equally to all Clearing Members and market
participants. Moreover, the proposed rule change would continue to
allow for a notification period of at least 30 days following the
filing of a revised Schedule of Fees with the Commission before such a
proposed fee change could be implemented. As a result, OCC believes
that the proposed rule change would not have any impact or impose a
burden on competition.
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    \13\ 15 U.S.C. 78q-1(b)(3)(I).
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(C) Clearing Agency's Statement on Comments on the Proposed Rule Change
Received From Members, Participants or Others

    Written comments on the proposed rule change were not and are not
intended to be solicited with respect to the proposed rule change and
none have been received.

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

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period up to 90 days (i) as the
Commission may designate if it finds such longer period to be
appropriate and publishes its reasons for so finding or (ii) as to
which the self- regulatory organization consents, the Commission will:
    (A) by order approve or disapprove the proposed rule change, or
    (B) institute proceedings to determine whether the proposed rule
change should be disapproved.
    OCC respectfully requests that the Commission approve the proposed
rule change on an accelerated basis pursuant to Section
19(b)(2)(C)(iii) of the Act.\14\ OCC believes that good cause exists
for the Commission to accelerate the effectiveness of the proposed rule
change because the proposed changes to the Fee Policy would improve
OCC's ability to implement fee changes that are more accurately
calibrated to meet the requirements of its Fee Policy and Capital Plan.
As describe above, OCC believes that the current 60-day implementation
period under the Fee Policy (i) increases the difficulty of projecting
appropriate fee levels needed to cover OCC's operating expenses plus
the Business Risk Buffer given the amount of time that passes between
OCC's analysis and the implementation of the fee change, (ii) increases
the risk that by the time the fee change is implemented, the extended
delay in implementation may result in revenues that diverge further
from the target the Business Risk Buffer (either higher or lower), and
(iii) increases the impact of a fee change due to the delayed
implementation timing. As a result, OCC may need to make more frequent
and/or more dramatic changes to its Schedule of Fees in order to
maintain its target Business Risk Buffer, resulting in less stability
in fees for OCC's participants. OCC believes that reducing the 60-day
implementation period to 30 days would allow for fee adjustments that
are based on revenue and expense data that is more current, and
therefore projections that are more accurate and fee levels that are
generally more stable. Accordingly, OCC believes the proposed rule
change promotes OCC's ability to comply with its obligations under the
Act to be efficient and effective in meeting the requirements of its
participants and the markets it serves.
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    \14\ 15 U.S.C. 78s(b)(2)(C)(iii).
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    While the proposed rule change would reduce the 60-day notification
period prior to implementing fee changes under the Fee Policy, any
proposed fee change would still require at least a 30-day notification
period prior to implementation and would continue to be subject to the
Commission's rule filing process, including the notice and public
comment period. OCC believes that the proposed 30-day implementation
period, along with the Commission's rule filing process, would continue
to provide Clearing Members and other market participants with
appropriate and adequate notice of fee changes so that they are able to
take any necessary action to prepare for the proposed fee change.
Moreover, participants would continue to have an opportunity to comment
on any fee changes prior to such fee change being implemented, and the
Commission would continue to review all such fee changes as part of the
proposed rule change process. OCC notes that the proposed rule change
would not alter the manner in which OCC determines potential fee
changes under its Fee Policy or the applicability of any such fee
changes to its Clearing Members and market participants.
    For all of the reasons above, OCC requests that the Commission
approve the proposed rule change on an accelerated basis because there
is good cause consistent with the Act.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
File Number SR-OCC-2018-001 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-OCC-2018-001. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549, on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of such filing also will be available for inspection
and copying at the principal office of OCC and on OCC's website at
https://www.theocc.com/about/publications/bylaws.jsp.
    All comments received will be posted without change. Persons
submitting comments are cautioned that we do not redact or edit
personal identifying information from comment submissions. You should
submit only information

that you wish to make available publicly.
    All submissions should refer to File Number SR-OCC-2018-001 and
should be submitted on or before February 14, 2018.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\15\
Eduardo A. Aleman,
Assistant Secretary.
---------------------------------------------------------------------------

    \15\ 17 CFR 200.30-3(a)(12).
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[FR Doc. 2018-01676 Filed 1-29-18; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 86, Number 102 (Friday, May 28, 2021)]
[Notices]
[Pages 28849-28851]
[FR Doc No: 2021-11384]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0455]

Revocation of Authorization of Emergency Use of a Medical Device
During COVID-19; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
revocation of the Emergency Use Authorization (EUA) (the Authorization)
issued to Battelle Memorial Institute for the Battelle Critical Care
Decontamination System. FDA revoked the Authorization on April 30,
2021, under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as
requested by Battelle Memorial Institute on April 2, 2021. The
revocation, which includes an explanation of the reasons for the
revocation, is reprinted in this document.

DATES: The Authorization for the Battelle Critical Care Decontamination
System is revoked as of April 30, 2021.

ADDRESSES: Submit written requests for a single copy of the revocation
to the Office of Counterterrorism and Emerging Threats, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4338, Silver
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist
that office in processing your request or include a Fax number to which
the revocation may be sent. See the SUPPLEMENTARY INFORMATION section
for electronic access to the revocation.

FOR FURTHER INFORMATION CONTACT: Jennifer J. Ross, Office of
Counterterrorism and Emerging Threats, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 1, Rm. 4332, Silver Spring, MD 20993-
0002,<PHONE_NUMBER> (this is not a toll-free number).

SUPPLEMENTARY INFORMATION:

I. Background

    Section 564 of the FD&C Act (21 U.S.C. 360bbb-3) allows FDA to
strengthen the public health protections against biological, chemical,
nuclear, and radiological agents. Among other things, section 564 of
the FD&C Act allows FDA to authorize the use of an unapproved medical
product or an unapproved use of an approved medical product in certain
situations. On March 28, 2020, FDA issued the Authorization to Battelle
Memorial Institute for the Battelle Critical Care Decontamination
System. Notice of the issuance of the Authorization was published in
the Federal Register on June 5, 2020 (85 FR 34638), as required by
section 564(h)(1) of the FD&C Act. The authorization of a device for
emergency use under section 564 of the FD&C Act may, pursuant to
section 564(g)(2) of the FD&C Act, be revoked when the criteria under
section 564(c) of the FD&C Act for issuance of such authorization are
no

longer met (section 564(g)(2)(B) of the FD&C Act), or other
circumstances make such revocation appropriate to protect the public
health or safety (section 564(g)(2)(C) of the FD&C Act).

II. EUA Revocation Request for a Medical Device During COVID-19

    On April 2, 2021, Battelle Memorial Institute requested the
revocation of, and on April 30, 2021, FDA revoked, the Authorization
for the Battelle Critical Care Decontamination System. Because Battelle
Memorial Institute notified FDA that it has ceased operations and
associated activities and requests withdrawal of the Authorization, FDA
has determined that it is appropriate to protect the public health or
safety to revoke this Authorization.

III. Electronic Access

    An electronic version of this document and the full text of the
revocations are available on the internet at https://www.regulations.gov/ and https://www.fda.gov/media/148132/download.

IV. The Revocation

    Having concluded that the criteria for revocation of the
Authorization under section 564(g)(2)(C) of the FD&C Act are met, FDA
has revoked the EUA for the Battelle Critical Care Decontamination
System. The revocation in its entirety follows and provides an
explanation of the reasons for revocation, as required by section
564(h)(1) of the FD&C Act.
BILLING CODE 4164-01-P
[GRAPHIC] [TIFF OMITTED] TN28MY21.011

    Dated: May 24, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-11384 Filed 5-27-21; 8:45 am]
BILLING CODE 4164-01-C


[Federal Register Volume 78, Number 233 (Wednesday, December 4, 2013)]
[Notices]
[Pages 72901-72902]
[FR Doc No: 2013-28963]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-1444]

Draft Guidance; Pharmacy Compounding of Human Drug Products Under
Section 503A of the Federal Food, Drug, and Cosmetic Act; Withdrawal of
Guidances

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability; withdrawal.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing the availability of a draft guidance entitled ``Pharmacy
Compounding of Human Drug Products Under Section 503A of the Federal
Food, Drug, and Cosmetic Act''. The draft guidance announces the
Agency's intention with regard to enforcement of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) to regulate entities that
compound drugs, now that the FD&C Act has been amended by the Drug
Quality and Security Act. When final, the guidance will reflect the
Agency's current thinking on the issues addressed by the guidance.
    The Agency is also announcing the withdrawal of a guidance
entitled, ``Enforcement Policy During Implementation of Section 503A of
the Federal Food, Drug, and Cosmetic Act,'' which was issued in
November 1998, and the withdrawal of CPG Section 460.200 of the
Compliance Program Guidance (CPG) Manual entitled, ``Pharmacy
Compounding,'' which was issued in May 2002. These guidances are being
withdrawn because they are no longer consistent with the Agency's
current thinking on the issues they address.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on the
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by February 3, 2014.

ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Compliance Policy, Office of Enforcement,
Food and Drug Administration, rm. 4025, 12420 Parklawn Dr., Rockville,
MD 20857. Send one self-addressed adhesive label to assist that office
in processing your request. See the SUPPLEMENTARY INFORMATION section
for electronic access to the draft guidance.

FOR FURTHER INFORMATION CONTACT: Marissa Chaet Brykman, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, suite 5100, Silver Spring, MD 20993-0002,
301-796-3110.

SUPPLEMENTARY INFORMATION:

I. Announcement of Draft Guidance

    FDA is announcing the availability of a draft guidance entitled
``Pharmacy Compounding of Human Drug Products Under Section 503A of the
Federal Food, Drug, and Cosmetic Act.'' The draft guidance provides
information to compounders of human drug products and to FDA staff on
the Agency's application of section 503A of the FD&C Act (21 U.S.C.
353a) and current enforcement policies relating to the compounding of
human drug products.
    Section 503A of the FD&C Act describes the conditions that must be

satisfied for drug products compounded by a licensed pharmacist or
licensed physician to be exempt from the following three sections of
the FD&C Act: (1) Section 501(a)(2)(B) (21 U.S.C. 351(a)(2)(B))
(concerning current good manufacturing practice); (2) section 502(f)(1)
(21 U.S.C. 352(f)(1)) (concerning the labeling of drugs with adequate
directions for use); and (3) section 505 (21 U.S.C. 355) (concerning
the approval of drugs under new drug applications or abbreviated new
drug applications). All other applicable provisions of the FD&C Act
remain in effect for compounded drugs, however, even if the conditions
in section 503A are met.
    The conditions of section 503A of the FD&C Act included
restrictions on the advertising or promotion of the compounding of any
particular drug, class of drug, or type of drug, and the solicitation
of prescriptions for compounded drugs. These provisions were challenged
in court and struck down as unconstitutional by the U.S. Supreme Court
in 2002.\1\ Now that section 503A has been amended by the Drug Quality
and Security Act to remove the unconstitutional advertising, promotion,
and solicitation provisions, it is necessary to explain FDA's current
thinking with regard to section 503A. Several provisions of section
503A require rulemaking and consultation with a Pharmacy Compounding
Advisory Committee to implement. In the draft guidance, we explain how
those provisions will be applied pending those consultations and
rulemaking.
---------------------------------------------------------------------------

    \1\ See Thompson v. Western States Med. Ctr., 535 U.S. 357
(2002).
---------------------------------------------------------------------------

    Among other things, the draft guidance restates the provisions in
section 503A that remain in effect, describes FDA's interim policies
with respect to specific provisions in section 503A that require
implementing regulations or other actions, and contains a non-
exhaustive list of potential enforcement actions against individuals or
firms that compound human drug products.
    FDA is issuing the draft guidance as level 1 draft guidance
consistent with FDA's good guidance practices regulation (21 CFR
10.115). The draft guidance, when finalized, will represent FDA's
current thinking regarding section 503A of the FD&C Act and human drug
compounding. It does not create or confer any rights for or on any
person and does not operate to bind FDA or the public. An alternative
approach may be used if such approach satisfies the requirements of the
applicable statutes and regulations.

II. Withdrawal of 1998 Guidance and 2002 CPG

    In a notice published in the Federal Register of November 23, 1998
(63 FR 64723), FDA announced the availability of a guidance entitled
``Enforcement Policy During Implementation of Section 503A of the
Federal Food, Drug, and Cosmetic Act,'' which is now being withdrawn.
In a notice published in the Federal Register of June 7, 2002 (67 FR
39409), FDA announced the availability of CPG Section 460.200 of the
Compliance Program Guidance Manual entitled ``Pharmacy Compounding,''
which is also now being withdrawn. These two documents are being
withdrawn because they are no longer consistent with FDA's current
thinking on the issues they address.

III. Request for Comments

    Interested persons may submit either electronic comments regarding
the draft guidance to http://www.regulations.gov or written comments to
the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, or by
FAX:<PHONE_NUMBER>. It is only necessary to send one set of comments.
Identify comments with the docket number found in the brackets in the
heading of this document. Received comments may be seen in the Division
of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday,
and will be posted to the docket at http://www.regulations.gov.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm

    Dated: November 27, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
 [FR Doc. 2013-28963 Filed 12-2-13; 11:15 am]
BILLING CODE 4160-01-P


[Federal Register Volume 83, Number 137 (Tuesday, July 17, 2018)]
[Notices]
[Pages 33292-33295]
[FR Doc No: 2018-15261]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2018-0014]

Qualification of Drivers; Exemption Applications; Vision

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of applications for exemption; request for comments.

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

SUMMARY: FMCSA announces receipt of applications from 13 individuals
for an exemption from the vision requirement in the Federal Motor
Carrier Safety Regulations (FMCSRs) to operate a commercial motor
vehicle (CMV) in interstate commerce. If granted, the exemptions will
enable these individuals to operate CMVs in interstate commerce without
meeting the vision requirement in one eye.

DATES: Comments must be received on or before August 16, 2018.

ADDRESSES: You may submit comments bearing the Federal Docket
Management System (FDMS) Docket No. FMCSA-2018-0014 using any of the
following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the
    online instructions for submitting comments.
     Mail: Docket Management Facility; U.S. Department of
Transportation, 1200 New Jersey Avenue SE, West Building Ground Floor,
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery: West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue SE, Washington, DC, between 9 a.m. and 5 p.m.,
e.t., Monday through Friday, except Federal Holidays.
     Fax: 1-202-493-2251.
    Instructions: Each submission must include the Agency name and the
docket number(s) for this notice. Note that all comments received will
be posted without change to http://www.regulations.gov, including any
personal information provided. Please see the Privacy Act heading below
for further information.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov at any time or Room W12-140
on the ground level of the West Building, 1200 New Jersey Avenue SE,
Washington, DC, between 9 a.m. and 5 p.m., e.t., Monday through Friday,
except Federal holidays. The FDMS is available 24 hours each day, 365
days each year. If you want acknowledgment that we received your
comments, please include a self-addressed, stamped envelope or postcard
or print the acknowledgement page that appears after submitting
comments online.
    Privacy Act: In accordance with 5 U.S.C. 553(c), DOT solicits
comments from the public to better inform its rulemaking process. DOT
posts these comments, without edit, including any personal information
the commenter provides, to http://www.regulations.gov, as described in
the system of records notice (DOT/ALL-14 FDMS), which can be reviewed
at http://www.dot.gov/privacy.

FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, Chief,
Medical Programs Division,<PHONE_NUMBER>, [email protected], FMCSA,
Department of Transportation, 1200 New Jersey Avenue SE, Room W64-224,
Washington, DC 20590-0001. Office hours are 8:30 a.m. to 5 p.m., e.t.,
Monday through Friday, except Federal holidays. If you have questions
regarding viewing or submitting material to the docket, contact Docket
Services, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
from the FMCSRs for a five-year period if it finds ``such exemption
would likely achieve a level of safety that is equivalent to or greater
than the level that would be achieved absent such exemption.'' The
statute also allows the Agency to renew exemptions at the end of the
five-year period. FMCSA grants exemptions from the FMCSRs for a two-
year period to align with the maximum duration of a driver's medical
certification.
    The 13 individuals listed in this notice have requested an
exemption from the vision requirement in 49 CFR 391.41(b)(10).
Accordingly, the Agency will evaluate the qualifications of each
applicant to determine whether granting an exemption will achieve the
required level of safety mandated by statute.
    The physical qualification standard for drivers regarding vision
found in 49 CFR 391.41(b)(10) states that a person is physically
qualified to drive a CMV if that person has distant visual acuity of at
least 20/40 (Snellen) in each eye without corrective lenses or visual
acuity separately corrected to 20/40 (Snellen) or better with
corrective lenses, distant binocular acuity of at least 20/40 (Snellen)
in both eyes with or without corrective lenses, field of vision of at
least 70[deg] in the horizontal

Meridian in each eye, and the ability to recognize the colors of
traffic signals and devices showing standard red, green, and amber.
    In July 1992, the Agency first published the criteria for the
Vision Waiver Program, which listed the conditions and reporting
standards that CMV drivers approved for participation would need to
meet (Qualification of Drivers; Vision Waivers, 57 FR 31458, July 16,
1992). The current Vision Exemption Program was established in 1998,
following the enactment of amendments to the statutes governing
exemptions made by Sec.  4007 of the Transportation Equity Act for the
21st Century (TEA-21), Public Law 105-178, 112 Stat. 107, 401 (June 9,
1998). Vision exemptions are considered under the procedures
established in 49 CFR part 381 subpart C, on a case-by-case basis upon
application by CMV drivers who do not meet the vision standards of 49
CFR 391.41(b)(10).
    To qualify for an exemption from the vision requirement, FMCSA
requires a person to present verifiable evidence that he/she has driven
a commercial vehicle safely with the vision deficiency for the past
three years. Recent driving performance is especially important in
evaluating future safety, according to several research studies
designed to correlate past and future driving performance. Results of
these studies support the principle that the best predictor of future
performance by a driver is his/her past record of crashes and traffic
violations. Copies of the studies may be found at Docket Number FMCSA-
1998-3637.
    FMCSA believes it can properly apply the principle to monocular
drivers, because data from the Federal Highway Administration's (FHWA)
former waiver study program clearly demonstrated the driving
performance of experienced monocular drivers in the program is better
than that of all CMV drivers collectively (See 61 FR 13338, 13345,
March 26, 1996). The fact that experienced monocular drivers
demonstrated safe driving records in the waiver program supports a
conclusion that other monocular drivers, meeting the same qualifying
conditions as those required by the waiver program, are also likely to
have adapted to their vision deficiency and will continue to operate
safely.
    The first major research correlating past and future performance
was done in England by Greenwood and Yule in 1920. Subsequent studies,
building on that model, concluded that crash rates for the same
individual exposed to certain risks for two different time periods vary
only slightly (See Bates and Neyman, University of California
Publications in Statistics, April 1952). Other studies demonstrated
theories of predicting crash proneness from crash history coupled with
other factors. These factors--such as age, sex, geographic location,
mileage driven and conviction history--are used every day by insurance
companies and motor vehicle bureaus to predict the probability of an
individual experiencing future crashes (See Weber, Donald C.,
``Accident Rate Potential: An Application of Multiple Regression
Analysis of a Poisson Process,'' Journal of American Statistical
Association, June 1971). A 1964 California Driver Record Study prepared
by the California Department of Motor Vehicles concluded that the best
overall crash predictor for both concurrent and nonconcurrent events is
the number of single convictions. This study used three consecutive
years of data, comparing the experiences of drivers in the first two
years with their experiences in the final year.

II. Qualifications of Applicants

Ronald D. Blakely

    Mr. Blakely, 63, has had amblyopia in his left eye since childhood.
The visual acuity in his right eye is 20/20, and in his left eye, 20/
50. Following an examination in 2018, his optometrist stated, ``I feel
that Ron has sufficient vision to perform the driving tasks required to
operate a commercial vehicle since the amblyopia is longstanding,
stable, and he is well adjusted.'' Mr. Blakely reported that he has
driven straight trucks for 35 years, accumulating 1.58 million miles,
and buses for one year, accumulating 25,000 miles. He holds a Class CB
CDL from Michigan. His driving record for the last three years shows no
crashes and no convictions for moving violations in a CMV.

Homero Dominguez

    Mr. Dominguez, 51, has a prosthetic left eye due to a traumatic
incident in 2000. The visual acuity in his right eye is 20/20, and in
his left eye, no light perception. Following an examination in 2018,
his optometrist stated, ``In my opinion Mr. Dominguez has sufficient
vision to perform the driving tasks required to operate a commercial
vehicle.'' Mr. Dominguez reported that he has driven tractor-trailer
combinations for four years, accumulating 340,000 miles. He holds a
Class A CDL from Texas. His driving record for the last three years
shows no crashes and no convictions for moving violations in a CMV.

Larry L. George

    Mr. George, 59, has had a corneal scar in his right eye since
childhood. The visual acuity in his right eye is counting fingers, and
in his left eye, 20/25. Following an examination in 2018, his
ophthalmologist stated, ``Mr. George's vision is sufficient to drive a
commercial vehicle.'' Mr. George reported that he has driven straight
trucks for two years, accumulating 100,000 miles, and tractor-trailer
combinations for 30 years, accumulating 6 million miles. He holds an
operator's license from Louisiana. His driving record for the last
three years shows no crashes and no convictions for moving violations
in a CMV.

Jason C. Hetrick

    Mr. Hetrick, 38, has complete loss of vision in his left eye due to
a traumatic incident in 1987. The visual acuity in his right eye is 20/
20, and in his left eye, no light perception. Following an examination
in 2018, his optometrist stated, ``Based on my understanding of the
visual requirements for commercial vehicle operation, Mr. Hetrick has
sufficient vision to perform the driving tasks required to operate a
commercial vehicle.'' Mr. Hetrick reported that he has driven straight
trucks for 25 years, accumulating 381,250 miles, and tractor-trailer
combinations for seven years, accumulating 3,500 miles. He holds an
operator's license from Pennsylvania. His driving record for the last
three years shows no crashes and no convictions for moving violations
in a CMV.

Michael A. Hildebrand

    Mr. Hildebrand, 40, has had posterior staphyloma in his right eye
since childhood. The visual acuity in his right eye is count fingers,
and in his left eye, 20/20. Following an examination in 2018, his
optometrist stated, ``In my medical opinion, Michael Hildebrand has
sufficient vision to perform the driving tasks required to operate a
commercial vehicle.'' Mr. Hildebrand reported that he has driven
straight trucks for 12 years, accumulating 374,400 miles. He holds an
operator's license from Pennsylvania. His driving record for the last
three years shows no crashes and no convictions for moving violations
in a CMV.

Junior M. Isenberg

    Mr. Isenberg, 63, has had amblyopia in his left eye since birth.
The visual acuity in his right eye is 20/20, and in his left eye, 20/
400. Following an examination in 2018, his optometrist stated, ``In my
opinion, Junior Isenberg has sufficient vision to perform the

driving task to operate a commercial vehicle.'' Mr. Isenberg reported
that he has driven straight trucks for 30 years, accumulating 1.5
million miles. He holds a Class B CDL from Kentucky. His driving record
for the last three years shows no crashes and no convictions for moving
violations in a CMV.

David G. Livingston

    Mr. Livingston, 55, has had amblyopia in his right eye since
childhood. The visual acuity in his right eye is 20/200, and in his
left eye, 20/20. Following an examination in 2018, his optometrist
stated, ``This is a second letter to express that it is my medical
opinion that Mr. Livingston has sufficient vision in his left eye to
perform the driving tasks required to operate a commercial vehicle.''
Mr. Livingston reported that he has driven straight trucks for 18
years, accumulating 360,000 miles, and tractor-trailer combinations for
18 years, accumulating 360,000 miles. He holds a Class A CDL from
Vermont. His driving record for the last three years shows no crashes
and no convictions for moving violations in a CMV.

Joseph P. Markley

    Mr. Markley, 61, has had macular myelinated nerve fibers in his
right eye since birth. The visual acuity in his right eye is counting
fingers, and in his left eye, 20/25. Following an examination in 2018,
his ophthalmologist stated, ``Mr. Markley has sufficient vision in left
eye to perform the tasks required to operate a commercial vehicle.''
Mr. Markley reported that he has driven straight trucks for 39 years,
accumulating 42,900 miles, and tractor-trailer combinations for 39
years, accumulating 91,650 miles. He holds a Class AM CDL from
Pennsylvania. His driving record for the last three years shows no
crashes and no convictions for moving violations in a CMV.

Derek L. Redford

    Mr. Redford, 65, has an irregularly shaped pupil in his left eye
due to a traumatic incident in childhood. The visual acuity in his
right eye is 20/20, and in his left eye, counting fingers. Following an
examination in 2018, his optometrist stated, ``I hereby certify that in
my medical opinion the patient has sufficient vision to perform the
driving tasks required to operate a commercial vehicle.'' Mr. Redford
reported that he has driven straight trucks for ten years, accumulating
500,000 miles. He holds an operator's license from Idaho. His driving
record for the last three years shows no crashes and no convictions for
moving violations in a CMV.

David Tavarez

    Mr. Tavarez, 49, has had amblyopia in his right eye since birth.
The visual acuity in his right eye is hand motion, and in his left eye,
20/20. Following an examination in 2018, his optometrist stated,
``Based upon the color vision testing,binocular [sic] field of vision
tests and quality of vision in his left eye, it is my medical opinion
that Mr. David Tavarez can adequately operate a commercial motor
vehicle at this time.'' Mr. Tavarez reported that he has driven
straight trucks for 21 years, accumulating 630,000 miles. He holds an
operator's license from New Jersey. His driving record for the last
three years shows no crashes and no convictions for moving violations
in a CMV.

William B. Van Drielen

    Mr. Van Drielen, 56, has a macular scar in his left eye due to a
traumatic incident in 2012. The visual acuity in his right eye is 20/
20, and in his left eye, 20/50. Following an examination in 2018, his
optometrist stated, ``In my medical opinion, Mr. Vandrielen [sic] has
sufficient vision to perform the driving tasks required to operate a
commercial vehicle.'' Mr. Van Drielen reported that he has driven
straight trucks for five years, accumulating 1 million miles, and
tractor-trailer combinations for 36 years, accumulating 3.85 million
miles. He holds a Class AM CDL from Nevada. His driving record for the
last three years shows no crashes and no convictions for moving
violations in a CMV.

Willie R. White, Jr.

    Mr. White, 62, has had optic nerve damage in his left eye since
2012. The visual acuity in his right eye is 20/20, and in his left eye,
light perception. Following an examination in 2018, his optometrist
stated, ``In my medical opinion this patient has sufficient vision to
perform the driving tasks required to operate a commercial vehicle.''
Mr. White reported that he has driven straight trucks for ten years,
accumulating 150,000 miles, and tractor-trailer combinations for 20
years, accumulating two million miles. He holds a Class A CDL from
Nevada. His driving record for the last three years shows no crashes
and one conviction for a moving violation in a CMV; he exceeded the
speed limit by 9 mph.

Curtis C. Williams

    Mr. Williams, 63, has a retinal detachment in his right eye due to
a traumatic incident in 2010. The visual acuity in his right eye is
hand motion, and in his left eye, 20/20. Following an examination in
2017, his optometrist stated, ``In my opinion Mr. Williams has
sufficient vision to perform the daily task required to operate a
commercial vehicle.'' Mr. Williams reported that he has driven straight
trucks for 26 years, accumulating 1.24 million miles, and tractor-
trailer combinations for 26 years, accumulating 1.24 million miles. He
holds a Class A CDL from Missouri. His driving record for the last
three years shows no crashes and no convictions for moving violations
in a CMV.

III. Request for Comments

    In accordance with 49 U.S.C. 31136(e) and 31315, FMCSA requests
public comment from all interested persons on the exemption petitions
described in this notice. We will consider all comments and material
received before the close of business on the closing date indicated in
the dates section of the notice.

IV. Submitting Comments

    You may submit your comments and material online or by fax, mail,
or hand delivery, but please use only one of these means. FMCSA
recommends that you include your name and a mailing address, an email
address, or a phone number in the body of your document so that FMCSA
can contact you if there are questions regarding your submission.
    To submit your comment online, go to http://www.regulations.gov and
in the search box insert the docket number FMCSA-2018-0014 and click
the search button. When the new screen appears, click on the blue
``Comment Now!'' button on the right hand side of the page. On the new
page, enter information required including the specific section of this
document to which each comment applies, and provide a reason for each
suggestion or recommendation. If you submit your comments by mail or
hand delivery, submit them in an unbound format, no larger than 8\1/2\
by 11 inches, suitable for copying and electronic filing. If you submit
comments by mail and would like to know that they reached the facility,
please enclose a stamped, self-addressed postcard or envelope.
    We will consider all comments and materials received during the
comment period. FMCSA may issue a final determination at any time after
the close of the comment period.

V. Viewing Comments and Documents

    To view comments, as well as any documents mentioned in this
preamble, go to http://www.regulations.gov and in the search box insert
the docket number FMCSA-2018-0014 and click ``Search.''

Next, click ``Open Docket Folder'' and you will find all documents and
comments related to this notice.

    Issued on: July 12, 2018.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2018-15261 Filed 7-16-18; 8:45 am]
 BILLING CODE 4910-EX-P


[Federal Register Volume 76, Number 92 (Thursday, May 12, 2011)]
[Notices]
[Pages 27687-27689]
[FR Doc No: 2011-11680]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-64434; File No. SR-CBOE-2011-049]

Self-Regulatory Organizations; Chicago Board Options Exchange,
Incorporated; Notice of Proposed Rule Change Related to the Individual
Trading Pause Pilot and CBSX Market-Maker Quoting Obligations

May 6, 2011.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on May 4, 2011, the Chicago Board Options Exchange, Incorporated
(``Exchange'' or ``CBOE'') filed with the Securities and Exchange
Commission (``SEC'' or ``Commission'') the proposed rule change as
described in Items I and II below, which Items have been prepared by
the Exchange. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange is proposing to amend CBOE Stock Exchange, LLC's
(``CBSX'', the CBOE's stock trading facility) rules to include
additional stocks in the individual stock trading pause pilot and to
include certain conforming amendments to the CBSX Market-Maker quoting
obligation provisions. The Exchange is also proposing certain other
conforming and non-substantive amendments to CBSX's individual stock
trading pause provisions and CBOE's options trading halt provisions.
The text of the rule proposal is available on the Exchange's Web site
(http://www.cboe.org/legal), at the Exchange's Office of the Secretary
and at the Commission.

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

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

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

1. Purpose
    With respect to CBSX, the Exchange proposes to amend Rule 6.3C to
include additional stocks in the pilot by which such rule operates and
to amend Rules 53.23 and 53.56 to simplify certain aspects of the text
while also conforming certain percentages thereunder to the proposed
changes to Rule 6.3C. With respect to both CBSX and CBOE, the Exchange
proposes to make certain other conforming and non-substantive changes
to the text of Rules 6.3C and 6.3.06.
    The Commission approved Rule 6.3C on a pilot basis on June 10, 2010
to provide for trading pauses in individual stocks due to extraordinary
market volatility (``Trading Pause'') in all stocks included in the S&P
500 Index (``S&P 500'') (``Trading Pause Pilot'' or ``Pilot'').\3\ The
Exchange subsequently received approval to add to the Pilot the stocks
included in the Russell 1000 Index (``Russell 1000'') and a specified
list of Exchange Traded Products (``ETPs'').\4\
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    \3\ The Commission approved the Trading Pause Pilot for all
equities exchanges and FINRA. See Securities Exchange Act Release
Nos. 62252 (June 10, 2010), 75 FR 34186 (June 16, 2010) (File Nos.
SR-BATS-2010-014; SR-EDGA-2010-01; SR-EDGX-2010-01; SR-BX-2010-037;
SR-ISE-2010-48; SR-NYSE-2010-39; SR-NYSEAmex-2010-46; SR-NYSEArca-
2010-41; SR-NASDAQ-2010-061; SR-CHX-2010-10; SR-NSX-2010-05; and SR-
CBOE-2010-047) and 62251 (June 10, 2010), 75 FR 34183 (June 16,
2010) (SR-FINRA-2010-025).
    \4\ The Commission approved the addition to the Trading Pause
Pilot of the stocks included in the Russell 1000 and ETPs, where
applicable, for all equities exchanges and FINRA. See Securities
Exchange Act Release Nos. 62884 (September 10, 2010), 75 FR 56618
(September 16, 2010) (File Nos. SR-BATS-2010-018; SR-BX-2010-044;
SR-CBOE-2010-065; SR-CHX-2010-14; SR-EDGA-2010-05; SR-EDGX-2010-05;
SR-ISE-2010-66; SR-NASDAQ-2010-079; SR-NYSE-2010-49; SR-NYSEAmex-
2010-63; SR-NYSEArca-2010-61; and SR-NSX-2010-08) and 62883
(September 10, 2010), 75 FR 56608 (September 16, 2010) (SR-FINRA-
2010-033). The Exchange has subsequently extended the operation of
the Pilot, which was originally set to expire on December 10, 2010,
through the earlier of August 11, 2011 or the date on which a limit
up-limit down mechanism to address extraordinary market volatility,
if adopted, applies to the Circuit Breaker Stocks. See Securities
Exchange Act Release Nos. 63502 (December 9, 2010), 75 FR 78306
(December 15, 2010) (SR-CBOE-2010-112) (extension of Pilot through
April 11, 2011) and 64194 (April 5, 2011), 76 FR 20389 (April 12,
2011)(SR-CBOE-2011-031)(extension of Pilot through the earlier of
August 11, 2011 or the date on which a limit up-limit down mechanism
to address extraordinary market volatility, if adopted, applies to
the pilot stocks).
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    In consultation with other markets and the staff of the Commission,
the Exchange proposes to include all NMS stocks within the Pilot that
are not already included therein, but to apply a wider Threshold Move
percentage to the newly added stocks. Accordingly, the Exchange
proposes to amend the text of Rule 6.3C to provide that the Threshold
Move required to trigger an individual stock trading pause for the
proposed new stocks, as calculated by the primary listing market, to be
30% or more for such stocks priced at $1 or higher and 50% or more for
such stocks priced less than $1.\5\ The Exchange believes that these
percentages are commensurate

with the characteristics shared by the proposed new stocks within these
price ranges and would promote the objectives of the Trading Pause
Pilot to reduce the negative impacts of unanticipated price movements
in a security. In particular, the proposed additional stocks are those
not currently included in the S&P 500 Index, Russell 1000 Index, or
specified ETPs, and therefore are more likely to be less liquid
securities or securities with lower trading volumes. Accordingly, the
Exchange believes that broader Threshold Move percentages would be
appropriate. Similarly, because leveraged ETPs trade at a ratio against
the associated index, a broader Threshold Move percentage would also be
appropriate for leveraged ETPs. With respect to the 30% threshold for
stocks priced at $1 or higher and the 50% threshold for stocks priced
less than $1, the rationale for this differentiation is that lower-
priced securities may tend to be more volatile, and price movements of
lower-priced stocks equate to a higher percentage move than a similar
price change for a higher-priced stock.
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    \5\ Under the proposed rule change, the price of a stock would
be based on the closing price on the previous trading day, or, if no
closing price exists, the last sale reported to the Consolidated
Tape on the previous trading day.
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    The Exchange proposes to include new subsections 6.3C.03(a), (b)
and (c) to reflect the distinction between the applicable Threshold
Move percentages for current Pilot stocks and the proposed new stocks
to be included within the Pilot.\6\ The Exchange also proposes to make
certain other conforming and non-substantive changes to the text of
Rules 6.3C and 6.3.06.\7\ The Exchange is not proposing any other
substantive changes to the text of Rule 6.3C or the operation of the
Pilot, and will continue in consultation with the other markets to
assess whether the parameters for invoking a Trading Pause continue to
be appropriate and whether the parameters should be modified.
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    \6\ The Exchange is not proposing a change to the Threshold Move
percentage applicable to stocks currently included within the
current Pilot. However, the changes proposed herein would require
that certain rule text pertaining to the Threshold Move for the
existing Pilot stocks be reorganized within Rule 6.3C.
    \7\ The Exchange is proposing certain other conforming and non-
substantive amendments to Rules 6.3C (pertaining to CBSX) and 6.3.06
(pertaining to CBOE). Specifically, the Exchange is proposing to
replace certain references in these rules to ``Circuit Breaker
Stocks'' and ``eligible underlying stock'' with conforming
references to ``NMS stocks'' and ``underlying NMS stock.'' The
Exchange is also proposing to include text in these rules confirming
that, following an individual stock trading pause, trading will
generally resume on the primary listing market after a period of
five minutes, which is consistent with the current Pilot and is
simply intended to provide more detail in the text explaining the
existing Pilot's operation.
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    The proposed changes to the Pilot, if approved, would require that
the text of Rules 53.23.01 and 53.56.01, which pertains to the pricing
obligations that CBSX Market-Makers are required to adhere to, be
amended to update the cross-references therein to Rule 6.3C and the
Threshold Moves thereunder. Specifically, the Exchange proposes to
remove any text from the two rules addressing NMS stocks that are not
subject to the Pilot because no such stocks would exist and such text
would therefore be unnecessary. The Exchange also proposes to simplify
the two rules by explicitly stating the percentages that are applicable
thereunder and the times during the trading day when Rule 6.3C is not
in effect.\8\ The Exchange notes that part of this proposed change
would be substantive, in that the percentages under the two rules would
decrease slightly for the proposed new stocks priced at $1 or greater.
The Exchange believes that this proposed substantive change would not
have a significant impact on CBSX Market-Maker pricing obligations and
is reasonable because it would ensure that the designated quoting
percentages in the rules are within a narrower range than the
percentages necessary to trigger a Trading Pause.
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    \8\ The Exchange is also proposing a non-substantive amendment
to Rules 53.23 and 53.56 to correct a typographical error (replacing
the phrase ``Market-Marker'' with ``Market-Maker'').
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2. Statutory Basis
    The statutory basis for the proposed rule change is Section 6(b)(5)
of the Act,\9\ which requires the rules of an exchange to promote just
and equitable principles of trade, to remove impediments to and perfect
the mechanism of a free and open market and a national market system
and, in general, to protect investors and the public interest. The
proposed rule change also is designed to support the principles of
Section 11A(a)(1) \10\ of the Act in that it seeks to assure fair
competition among brokers and dealers and among exchange markets. The
Exchange believes that the proposed rule meets these requirements
because it expands the scope of the Pilot to cover all NMS stocks while
adjusting the parameters of the rule for different stocks in a manner
that will promote uniformity across markets concerning decisions to
pause trading in a stock when there are significant price movements.
Additionally, the proposed changes would ensure that the designated
quoting percentages in Rules 53.23 and 53.56 are within a narrower
range than the percentages necessary to trigger a Trading Pause.
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    \9\ 15 U.S.C. 78f(b)(5).
    \10\ 15 U.S.C. 78k-1(a)(1).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    CBOE does not believe that the proposed rule change will impose any
burden on competition not necessary or appropriate in furtherance of
the purposes of the Act.

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

    The Exchange neither solicited nor received comments on the
proposal.

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

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:
    (A) By order approve or disapprove such proposed rule change, or
    (B) Institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-CBOE-2011-049 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-CBOE-2011-049. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's

Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the
submission, all subsequent amendments, all written statements with
respect to the proposed rule change that are filed with the Commission,
and all written communications relating to the proposed rule change
between the Commission and any person, other than those that may be
withheld from the public in accordance with the provisions of 5 U.S.C.
552, will be available for Web site viewing and printing in the
Commission's Public Reference Room, 100 F Street, NE., Washington, DC
20549, on official business days between the hours of 10 a.m. and 3
p.m. Copies of such filing also will be available for inspection and
copying at the principal office of CBOE. All comments received will be
posted without change; the Commission does not edit personal
identifying information from submissions. You should submit only
information that you wish to make publicly available. All submissions
should refer to File Number SR-CBOE-2011-049 and should be submitted on
or before June 2, 2011.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\11\
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    \11\ 17 CFR 200.30-3(a)(12).
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Elizabeth M. Murphy,
Secretary.
[FR Doc. 2011-11680 Filed 5-11-11; 8:45 am]
BILLING CODE 8011-01-P