[Federal Register Volume 81, Number 250 (Thursday, December 29, 2016)]
[Notices]
[Pages 96174-96176]
[FR Doc No: 2016-31558]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2014-0216]

Qualification of Drivers; Exemption Applications; Epilepsy and
Seizure Disorders

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

ACTION: Notice of renewal of exemptions; request for comments.

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SUMMARY: FMCSA announces its decision to renew exemptions of three
individuals from the requirement in the Federal Motor Carrier Safety
Regulations (FMCSRs) that interstate commercial motor vehicle (CMV)
drivers have ``no established medical history or clinical diagnosis of
epilepsy or any other condition which is likely to cause loss of
consciousness or any loss of ability to control a CMV.'' The exemptions
enable these individuals who have had one or more seizures and are
taking anti-seizure medication to continue to operate CMVs in
interstate commerce.

DATES: The renewed exemptions were effective on November 4, 2016. The
renewed exemptions will expire on November 4, 2018. Comments must be
received on or before January 30, 2017.

FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, Chief,
Medical Programs Division,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA,
Department of Transportation, 1200 New Jersey Avenue SE., Room W64-224,
Washington, DC 20590-0001. Office hours are from 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>.

ADDRESSES: You may submit comments bearing the Federal Docket
Management System (FDMS) Docket No. FMCSA-2014-0216 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.

I. Background

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
for two years 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 two-year period.
    The physical qualification standard for drivers regarding epilepsy
found in 49 CFR 391.41(b)(8) states that a person is physically
qualified to drive a CMV if that person:

    Has no established medical history or clinical diagnosis of
epilepsy or any other condition which is likely to cause the loss of
consciousness or any loss of ability to control a CMV.

    In addition to the regulations, FMCSA has published advisory
criteria to assist Medical Examiners in determining whether drivers
with certain medical conditions are qualified to operate a CMV in
interstate commerce. [49 CFR part 391, Appendix A to Part 391--Medical
Advisory Criteria, section H. Epilepsy: Sec.  391.41(b)(8), paragraphs
3, 4, and 5.]
    The three individuals listed in this notice have requested renewal
of their exemptions from the Epilepsy and Seizure Disorders prohibition
in 49 CFR 391.41(b)(8), in accordance with FMCSA procedures.
Accordingly, FMCSA has evaluated these applications for renewal on
their merits and decided to extend each exemption for a renewable two-
year period.

II. Request for Comments

    Interested parties or organizations possessing information that
would otherwise show that any, or all, of these drivers are not
currently achieving the statutory level of safety should immediately
notify FMCSA. The Agency will evaluate any adverse evidence submitted
and, if safety is being compromised or if continuation of the exemption
would not be consistent with the goals and objectives of 49 U.S.C.
31136(e) and 31315, FMCSA will take immediate steps to revoke the
exemption of a driver.

III. Basis for Renewing Exemptions

    Under 49 U.S.C. 31315(b)(1), an exemption may be granted for no
longer than two years from its approval date and may be renewed upon
application. In accordance with 49 U.S.C. 31136(e) and 31315, each of
the three applicants has satisfied the conditions for obtaining an
exemption from the Epilepsy and Seizure Disorder requirements and were
published in the Federal Register (80 FR 17542). In addition, for
Commercial Driver's License (CDL) holders, the Commercial Driver's
License Information System (CDLIS) and the Motor Carrier Management
Information System (MCMIS) are searched for crash and violation data.
For non-CDL holders, the Agency reviews the driving records from the
State Driver's Licensing Agency (SDLA). These factors provide an
adequate basis for predicting each driver's ability to continue to
safely operate a CMV in interstate commerce.
    The three drivers in this notice remain in good standing with the
Agency, have maintained their medical monitoring and have not exhibited
any medical issues that would compromise their ability to safely
operate a CMV during the previous two-year exemption period. FMCSA has
concluded that renewing the exemptions for each of these applicants is
likely to achieve a level of safety equal to that existing without the
exemption. Therefore, FMCSA has decided to renew each exemption for a
two-year period. In accordance with 49 U.S.C. 31136(e) and 31315, each
driver has received a renewed exemption.
    As of November 4, 2016, the following three individuals have
satisfied the renewal conditions for obtaining an exemption from the
Epilepsy and Seizure Disorders prohibition in 49 CFR 391.41(b)(8), from
driving CMVs in interstate commerce (80 FR 17542): Ronald Bland (OH);
Joseph Celedonia (MD); and Thomas Mitchell (MS). These drivers were
included in FMCSA-2014-0216. The exemptions were effective on November
4, 2016, and will expire on November 4, 2018.

IV. Conditions and Requirements

    The exemptions are extended subject to the following conditions:
(1) Each driver must remain seizure-free and maintain a stable
treatment during the two-year exemption period; (2) each driver must
submit annual reports from their treating physicians attesting to the
stability of treatment and that the driver has remained seizure-free;
(3) each driver must undergo an annual medical examination by a
certified Medical Examiner, as defined by 49 CFR 390.5; and (4) each
driver must provide a copy of the annual medical certification to the
employer for retention in the driver's qualification file, or keep a
copy of his/her driver's qualification file if he/she is self-employed.
The driver must also have a copy of the exemption when driving, for
presentation to a duly authorized Federal, State, or local enforcement
official. The exemption will be rescinded if: (1) The person fails to
comply with the terms and conditions of the exemption; (2) the
exemption has resulted in a lower level of safety than was maintained
before it was granted; or (3) continuation of the exemption would not
be consistent with the goals and objectives of 49 U.S.C. 31136(e) and
31315.

V. Preemption

    During the period the exemption is in effect, no State shall
enforce any law or regulation that conflicts with this exemption with
respect to a person operating under the exemption.

VI. Conclusion

    Based upon its evaluation of the three exemption applications,
FMCSA renews the exemptions of the aforementioned drivers from the
Epilepsy and Seizure

Disorders requirement in 49 CFR 391.41(b)(8). In accordance with 49
U.S.C. 31136(e) and 31315, each exemption will be valid for two years
unless revoked earlier by FMCSA.

    Issued on: December 19, 2016.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2016-31558 Filed 12-28-16; 8:45 am]
 BILLING CODE 4910-EX-P


[Federal Register: July 3, 2008 (Volume 73, Number 129)]
[Notices]
[Page 38263-38265]
[DOCID:fr03jy08-109]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-58041; File No. SR-ISE-2007-94]

Self-Regulatory Organizations; International Securities Exchange,
LLC; Notice of Filing of Proposed Rule Change as Modified by Amendments
No. 1 and 3 Thereto Relating to Reduction of the Order Handling and
Exposure Periods

June 26, 2008.
    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 October 5, 2007, the International Securities Exchange, LLC (``ISE''
or ``Exchange''), 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 substantially prepared by ISE. On
December 4, 2007, ISE filed Amendment No. 1 to the proposed rule
change. On May 22, 2008, ISE filed Amendment No. 2 to the proposed rule
change.\3\ On June 23, 2008, ISE filed Amendment No. 3 to the proposed
rule change. The Commission is publishing this notice to solicit
comments on the proposed rule change, as amended, from interested
persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ Amendment No. 2 was withdrawn on May 29, 2008.
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I. Self-Regulatory Organization's Statement of the Terms of the
Substance of the Proposed Rule Change

    The Exchange is proposing to reduce the order handling and exposure
periods contained in Exchange Rules 716 (Block Trades), 717
(Limitations on Orders), 723 (Price Improvement Mechanism for Crossing
Transactions), and 811 (Directed Orders) from three seconds to one
second.
    The text of the proposed rule change is available on the Exchange's
Web site (http://www.iseoptions.com), at the principal office of the
Exchange, and at the Commission's Public Reference Room.

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

    In its filing with the Commission, ISE 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. ISE has prepared summaries, set forth in Sections A, B,
and C below, of the most significant aspects of such statements.

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

1. Purpose
    The purpose of the proposed rule change is to reduce the order
handling and exposure periods contained in Exchange Rules 716 (Block
Trades), 717 (Limitations on Orders), 723 (Price Improvement Mechanism
for Crossing Transactions), and 811 (Directed Orders) from three
seconds to one second.
    Rule 716 contains the requirements applicable to the execution of
orders using the Block Order Mechanism, Facilitation Mechanism, and
Solicited Order Mechanism. The Block Order Mechanism allows members to
obtain liquidity for the execution of a block-size order, whereas the
Facilitation and Solicited Order Mechanisms allow members to enter
block-size cross transactions. Rule 723 contains the requirements
applicable to the execution of orders using the Price Improvement
Mechanism (``PIM''). The PIM allows members to enter cross transactions
of any size. Orders entered into any of these mechanisms
(``Mechanisms'') currently are exposed to all market participants for
three seconds, giving participants an opportunity to enter additional
trading interest before the orders are automatically executed. Under
the proposal, the exposure period for all four Mechanisms would be
reduced to one second.
    Rule 717 requires members to expose agency orders to the
marketplace before executing them as principal \4\ or executing them
against orders solicited from other members.\5\ Under Rule 717, an
order can be exposed either by entering it onto the Exchange and
waiting at least three seconds before entering the contra-side
proprietary or solicited order, or by utilizing the various mechanisms
that have an exposure period built into the functionality as described
above. Under the proposal, the exposure period for orders entered onto
the Exchange would be reduced to one second.\6\
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    \4\ Rule 717(d).
    \5\ Rule 717(e). The Exchange proposes to make a non-substantive
clean-up of Rule 717(e) to specify that members can use the
Facilitation Mechanism to execute solicited crosses. The
Facilitation Mechanism rule was amended earlier this year to allow
members to enter solicited crosses, and Rule 717(e) should have been
updated at that time. See Securities Exchange Act Release No. 55557
(March 29, 2007), 72 FR 16838 (April 5, 2007).
    \6\ Under Rule 717(d), a member may enter an agency order that
would execute against a pre-existing proprietary order on the
Exchange if such proprietary order was entered at least three
seconds prior to receipt of the agency order. Under the proposal,
this time period would also be reduced to one second.
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    Rule 811 contains the requirements applicable to the handling and
execution of Directed Orders. A Directed Order is an order routed from
an Electronic Access Member to an Exchange Market Maker (the ``Directed
Market Maker'') through the Exchange's system.\7\ A Directed Market
Maker is required to enter Directed Orders into the PIM or release the
order to the Exchange's limit order book within three seconds of
receipt.\8\ Under the proposal, this time period would be reduced to
one second.
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    \7\ Rule 811(a)(1).
    \8\ Rule 811(c)(3). If the Directed Market Maker fails to do so
within three seconds, the Exchange's system automatically releases
the order. Rule 811(c)(3)(ii).
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    Additionally, there are three instances when a Directed Order is
exposed to all market participants for three seconds after being
released to the Exchange's limit order book: (i) Before a Directed
Order is matched against the Directed Market Maker at the NBBO; \9\
(ii) before

executing a Directed Order against the Directed Market Maker's
Guarantee; \10\ and (iii) before being given to the Primary Market
Maker for handling where the Directed Market Maker is also the Primary
Market Maker.\11\ Under the proposal, these three exposure periods
would be reduced to one second.
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    \9\ If a Directed Market Maker is quoting at the NBBO at the
time it releases a Directed Order, the Directed Market Maker is last
in priority, and the order is exposed to all market participants
before the Directed Order is executed against the Directed Market
Maker's quote.
    \10\ If the Directed Market Maker is quoting at the NBBO on the
opposite side of the market from a Directed Order at the time the
Directed Order is received by the Directed Market Maker, and the
Directed Order is marketable, the Exchange's system will
automatically guarantee execution of the Directed Order against the
Directed Market Maker at the price and the size of the Directed
Market Maker's quote. Rule 811(d).
    \11\ As provided in Rule 714, when the Exchange's best bid or
offer is inferior to another exchange, incoming marketable customer
orders are handled by the Primary Market Maker pursuant to Rule
803(c), which requires the Primary Market Maker to either execute
the order at a price that matches the NBBO or attempt to obtain the
better price for the customer according to the Linkage rules
contained in Chapter 19.
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    Finally, if a Directed Order is placed on the Exchange's limit
order book, the Directed Market Maker is not permitted to enter a
proprietary order to execute against the Directed Order during the
three seconds following the release of the Directed Order. This
limitation would be reduced to one second under the proposal.
    In adopting the various three-second order handling and exposure
periods, ISE recognized that three seconds would not be long enough to
allow human interaction with the orders. Rather, market participants
had become sufficiently automated that they could react to these orders
electronically. In this context, ISE recognizes that it is in all
market participants' best interest to minimize the exposure period to a
time frame that continues to allow adequate time for market
participants to electronically respond, as both the order being exposed
and the participants responding to the order are subject to market risk
during the exposure period. In this respect, ISE's experience with the
three-second time period indicates one second would provide an adequate
response time. Indeed, most members wait until the end of the last
second of the three-second period before responding to exposed orders.
Accordingly, the Exchange does not believe it is necessary or
beneficial to the orders being exposed to continue to subject them to
market risk for a full three seconds.
    Recently, the Exchange distributed a survey to members that
regularly participate in orders executed through the Mechanisms that
would be affected by the proposal. To substantiate that its members
could receive, process, and communicate a response back to the Exchange
within one second, the survey asked members to identify how many
milliseconds it took for (i) a broadcast from ISE to reach their
systems; (ii) their systems to generate responses; and (iii) their
responses to reach the ISE. The survey results indicate that the time
it takes a message to travel between the Exchange and its members
typically is not more than fifty milliseconds each way.\12\ The survey
also indicated that it takes not more than ten milliseconds for member
systems to process the information and generate a response. Thus, the
survey indicated that it typically takes, at most, 110 milliseconds for
members to receive, process, and respond to broadcast messages related
to the various Mechanisms. Additionally, members indicated that
reducing the exposure period to one second would not impair their
ability to participate in orders executed through the Mechanisms.\13\
The Exchange believes that this information provides additional support
for its assertion that reducing the exposure periods from three seconds
to one second will continue to provide members with sufficient time to
ensure effective interaction with orders.
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    \12\ Eleven firms responded to the survey. Eight of the eleven
responded to the specific timing questions. Half of these members
communicate to the Exchange from Chicago. The others are located in
New York City, or operate from both New York City and Chicago.
    \13\ All of the eight members that responded to the specific
timing questions, and two of the three members that did not answer
the specific timing questions, indicated that reducing the crossing
exposure timer to one second would not impair their ability to
participate in ISE crossing orders. One member responded that it
could not measure the specific times and indicated that it would
prefer to keep the exposure periods at three seconds.
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    When approving the existing three-second order handling and
exposure periods, the Commission concluded that three seconds was
sufficient to afford electronic crowds sufficient time to compete for
orders.\14\ In reaching this conclusion, the Commission stated that the
critical issue is determining whether the three-second timeframe would
give participants in a fully automated marketplace sufficient time to
respond, compete and provide price improvement for orders, and whether
electronic systems were available to ISE members that would allow them
to respond in a meaningful way within the proposed timeframe.\15\ The
Commission noted that the ISE is a fully electronic exchange where
participants interact by electronic means, and that electronic systems
were readily available, if not already in place, that would allow ISE
members to respond.\16\
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    \14\ See Securities Exchange Act Release No. 50819 (December 8,
2004), 69 FR 75093 (December 15, 2004) (order approving PIM with
three-second order handling and exposure periods); Securities
Exchange Act Release No. 52711 (November 1, 2005), 70 FR 67508
(November 7, 2005) (reduction of exposure period for Facilitation
and Solicited Order Mechanisms from ten seconds to three seconds);
Securities Exchange Act Release No. 53850 (May 23, 2006), 71 FR
30703 (May 30, 2006) (reduction of exposure period for orders
entered on the Exchange under Rule 717(d) and (e) from thirty
seconds to three seconds); Securities Exchange Act Release No. 54531
(September 28, 2006), 71 FR 58649 (October 4, 2006) (reduction of
exposure period for Block Order Mechanism from thirty seconds to
three seconds).
    \15\ See Securities Exchange Act Release No. 50819 (December 8,
2004), 69 FR 75093 at 75096 (December 15, 2004) (order approving PIM
with three-second order handling and exposure periods).
    \16\ Id.
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    The Exchange believes reducing order handling and exposure periods
as discussed above from three seconds to one second would benefit all
market participants. Since members react to these orders
electronically, and generally only at the tail end of the three-second
period, reducing the time periods would continue to provide sufficient
time to ensure effective interaction with orders. At the same time,
reducing the time periods to one second would allow the Exchange to
provide investors and other market participants with more timely
executions, thereby reducing market risk.
2. Statutory Basis
    The basis under the Act for this proposed rule change is the
requirement under Section 6(b)(5) of the Act \17\ that an exchange have
rules that are designed to prevent fraudulent and manipulative acts and
practices, to promote just and equitable principles of trade, to remove
impediments to and perfect the mechanism for a free and open market and
a national market system, and, in general, to protect investors and the
public interest. In particular, ISE believes that the proposal will
benefit market participants by providing more timely executions.
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    \17\ 15 U.S.C. 78f(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The proposed rule change does not impose any burden on competition
that is 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 has not solicited, and does not intend to solicit,
comments on

this proposed rule change. The Exchange has not received any written
comments from members or other interested parties, except as described
below.
    In Amendment No. 3, ISE noted that the Commission received a
comment letter on another ISE rule proposal related to the price at
which a transaction may be effected through the PIM (the ``Price
Proposal''), which asserted that the combined effect of the Price
Proposal and this proposal to reduce the exposure period to one second
would be increased internalization rates.\18\ ISE further noted that
the Commission subsequently approved the Price Proposal, stating that
it did not agree with the concerns raised by the commenter and that the
PIM would continue to provide an opportunity for customer orders to
receive an execution at a price better than the NBBO.\19\ The
Commission stated in its approval order that the Price Proposal could
increase the likelihood of members entering agency orders into the PIM
because the members would only be required to guarantee an execution at
the NBBO, which would provide additional customer orders an opportunity
for price improvement. ISE also noted that the Commission mentioned in
its approval order the potential for the Price Proposal to encourage
increased participation in a PIM and that increased participation would
decrease the proportion of an agency order that would be internalized
by the submitting member.
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    \18\ Letter from Lisa J. Fall, General Counsel, Boston Options
Exchange, to Nancy M. Morris, Secretary, Commission, dated May 14,
2008 (commenting on File Number SR-ISE-2008-29).
    \19\ See Securities Exchange Act Release No. 57847 (May 21,
2008), 73 FR 30987 (May 29, 2008) (order approving File No. SR-ISE-
2008-29).
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    As the Exchange discusses in the Purpose section of this filing,
and as further supported by the results of the survey discussed above,
ISE members are able to respond to PIM orders in less than one second,
and therefore the Exchange does not believe this proposal will
discourage competition for PIM orders. Rather, ISE believes that this
rule change, like the Price Proposal, could provide additional customer
orders an opportunity for price improvement because it would reduce the
market risk for members that are required to guarantee an execution at
the NBBO or better.

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

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

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change 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-ISE-2007-94 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-ISE-2007-94. 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 inspection and
copying in the Commission's Public Reference Room, 100 F Street, NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of the ISE. All comments
received will be posted without change; the Commission does not edit
personal identifying information from submissions. You should submit
only information that you wish to make available publicly. All
submissions should refer to File Number SR-ISE-2007-94 and should be
submitted on or before July 24, 2008.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\20\
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    \20\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Acting Secretary.
[FR Doc. E8-15101 Filed 7-2-08; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register: January 28, 2008 (Volume 73, Number 18)]
[Notices]
[Page 4874-4875]
[DOCID:fr28ja08-64]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2008N-0017]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Exports: Notification and Recordkeeping Requirements

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the notification and
recordkeeping requirements for persons exporting human drugs,
biological products, devices, animal drugs, food, and cosmetics that
may not be marketed or sold in the United States.

DATES: Submit written or electronic comments on the collection of
information by March 28, 2008.

ADDRESSES: Submit electronic comments on the collection of information
to: http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of the Chief
Information Officer (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Exports: Notification and Recordkeeping Requirements, 21 CFR Part 1
(OMB Control Number 0910-0482) -- Extension

    The respondents to this information collection are exporters who
have notified FDA of their intent to export unapproved products that
may not be sold or marketed in the United States as allowed under
801(e) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C.
381). In general, the notification identifies the product being

exported (e.g. name, description, and in some cases, country of
destination) and specifies where the notification should be sent. These
notifications are sent only for an initial export; subsequent exports
of the same product to the same destination (or, in the case of certain
countries identified in section 802(b) of the act (21 U.S.C. 382), to
any of those countries would not result in a notification to FDA.
    The recordkeepers to this information collection are exporters who
export human drugs, biologics, devices animal drugs, foods and
cosmetics that may not be sold in the United States to maintain records
demonstrating their compliance with the requirements in section 801(e)
(1) of the act.
    The total burden estimate of 39,120 is based on the number of
notifications received by the relevant FDA centers in fiscal year 2007,
or the last year the figures available. FDA estimates the burden of
this collection of information as follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
                         No. of        Annual Frequency     Total Annual        Hours per
  21 CFR Section      Respondents        per Response        Responses           Response         Total Hours
----------------------------------------------------------------------------------------------------------------
1.101 (d)-(e)                    400                  3               1200                 15             18,000
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

                               Table 2.--Estimated Annual Recordkeeping Burden\1\
----------------------------------------------------------------------------------------------------------------
                         No. of        Annual Frequency     Total Annual        Hours per
  21 CFR Section     Recordkeepers     of Recordkeeping       Records          Recordkeeper       Total Hours
----------------------------------------------------------------------------------------------------------------
1.101 (b)-(c)                    320                  3                960                 22             21,120
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Please note that on January 15, 2008, the FDA Web site transitioned
to the Federal Dockets Management System (FDMS). FDMS is a Government-
wide, electronic docket management system. Electronic submissions will
be accepted by FDA through FDMS only.

    Dated: January 18, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8-1356 Filed 1-25-08; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 79, Number 92 (Tuesday, May 13, 2014)]
[Notices]
[Pages 27360-27361]
[FR Doc No: 2014-10898]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-72117; File No. SR-ISE-2014-09]

Self-Regulatory Organizations; International Securities Exchange,
LLC; Notice of Designation of a Longer Period for Commission Action on
Proposed Rule Change Related to Market Maker Risk Parameters

 May 7, 2014.
    On March 10, 2014, the International Securities Exchange, LLC (the
``Exchange'' or ``ISE'') filed with the Securities and Exchange
Commission (``Commission''), pursuant to Section 19(b)(1) of the
Securities Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4
thereunder,\2\ a proposed rule change to amend ISE Rules 722 and 804 to
mitigate market maker risk by adopting an Exchange-provided risk
management functionality. The proposed rule change was published for
comment in the Federal Register on March 26, 2014.\3\ The Commission
received no comments on the proposal.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 71759 (March 20,
2014), 79 FR 16850.
---------------------------------------------------------------------------

    Section 19(b)(2) of the Act \4\ provides that within 45 days of the
publication of notice of the filing of a proposed rule change, or
within such longer period up to 90 days as the Commission may designate
if it finds such longer period to be appropriate and publishes its
reasons for so finding or as to which the self-regulatory organization
consents, the Commission shall either approve the proposed rule change,
disapprove the proposed rule change, or institute proceedings to
determine whether the

proposed rule change should be disapproved. The 45th day for this
filing is May 10, 2014. The Commission is extending this 45-day time
period.
---------------------------------------------------------------------------

    \4\ 15 U.S.C. 78s(b)(2).
---------------------------------------------------------------------------

    The Commission finds it appropriate to designate a longer period
within which to take action on the proposed rule change, so that it has
sufficient time to consider this proposed rule change.
    Accordingly, the Commission, pursuant to Section 19(b)(2) of the
Act,\5\ designates June 24, 2014, as the date by which the Commission
shall either approve or disapprove, or institute proceedings to
determine whether to disapprove, the proposed rule change (File No. SR-
ISE-2014-09).
---------------------------------------------------------------------------

    \5\ Id.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\6\
---------------------------------------------------------------------------

    \6\ 17 CFR 200.30-3(a)(31).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-10898 Filed 5-12-14; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 82, Number 21 (Thursday, February 2, 2017)]
[Notices]
[Pages 9087-9089]
[FR Doc No: 2017-02180]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. IC-32456]

Notice of Applications for Deregistration Under Section 8(f) of
the Investment Company Act of 1940

January 27, 2017.
    The following is a notice of applications for deregistration under
section 8(f) of the Investment Company Act of 1940 for the month of
January 2017. A copy of each application may be obtained via the
Commission's Web site by searching for the file number, or for an
applicant using the Company name box, at http://www.sec.gov/search/search.htm or by calling<PHONE_NUMBER>. An order granting each
application will be issued unless the SEC orders a hearing. Interested
persons may request a hearing on any application by writing to the
SEC's Secretary at the address below and serving the relevant applicant
with a copy of the request, personally or by mail. Hearing requests
should be received by the SEC by 5:30 p.m. on February 21, 2017, and
should be accompanied by proof of service on applicants, in the form of
an affidavit or, for lawyers, a certificate of service. Pursuant to
Rule 0-5 under the Act, hearing requests should state the nature of the
writer's interest, any facts bearing upon the desirability of a hearing
on the matter, the reason for the request, and the issues contested.
Persons who wish to be notified of a hearing may request notification
by writing to the Commission's Secretary.

ADDRESSES:  The Commission: Secretary, U.S. Securities and Exchange
Commission, 100 F Street NE., Washington, DC 20549-1090.

FOR FURTHER INFORMATION CONTACT:  Jessica Shin, Attorney-Adviser, at
(202) 551-5921 or Chief Counsel's Office at<PHONE_NUMBER>; SEC,
Division of Investment Management, Chief Counsel's Office, 100 F Street
NE., Washington, DC 20549-8010.

Nuveen New York Performance Plus Municipal Fund Inc.

[File No. 811-05931]

    Summary: Applicant, a closed-end investment company, seeks an order
declaring that it has ceased to be an investment company. The applicant
has transferred its assets to Nuveen New York Dividend Advantage
Municipal Fund and, on May 26, 2015, made a final distribution to its
shareholders based on net asset value. Expenses of approximately
$38,358 incurred in connection with the reorganization were paid by
applicant and approximately $283,472 were paid by the acquiring fund.
    Filing Dates: The application was filed on January 22, 2016, and
amended on November 14, 2016, and December 14, 2016.
    Applicant's Address: 333 West Wacker Drive, Chicago, Illinois
60606.

Corsair Opportunity Fund

[File No. 811-22978]

    Summary: Applicant, a closed-end investment company, seeks an order
declaring that it has ceased to be an investment company. On December
15, 2016, applicant made a liquidating distribution to its
shareholders, based on net asset value. Expenses of $5,009 incurred in
connection with the liquidation were paid by applicant's investment
adviser.
    Filing Date: The application was filed on December 16, 2016.
    Applicant's Address: 366 Madison Avenue, 12th Floor, New York, New
York 10017.

SmartX ETF Trust

[File No. 811-22825]

    Summary: Applicant seeks an order declaring that it has ceased to
be an investment company. Applicant has never made a public offering of
its securities and does not propose to make a public offering or engage
in business of any kind.
    Filing Dates: The application was filed on December 9, 2016, and
amended on January 5, 2017.
    Applicant's Address: c/o Guinness Atkinson Asset Management Inc.,
21550 Oxnard Street, Suite 850, Woodland Hills, California 91367.

Vantagepoint Funds

[File No. 811-08941]

    Summary: Applicant seeks an order declaring that it has ceased to
be an investment company. On October 14, 2016, applicant made a final
liquidating distribution to its shareholders, based on net asset value.
Applicant has established a liquidating trust to provide for the
payment of certain identified contingent claims with respect to certain
series of applicant. The parent company of applicant's investment
adviser serves as administrator of the liquidating trust. Assets
remaining in the liquidating trust will be distributed to its
beneficiaries after the satisfaction of all claims. Expenses of
$1,693,244 incurred in connection with the liquidation were paid by
applicant and applicant's investment adviser. Applicant has retained
$4,232,893 in cash and cash equivalents at its custodian bank to pay
for certain accrued liabilities.
    Filing Dates: The application was filed on November 14, 2016 and
amended on January 5, 2017.
    Applicant's Address: 777 North Capitol Street NE., Suite 600,
Washington, District of Columbia 20002.

Matthews A Share Selections Fund, LLC

[File No. 811-22809]

    Summary: Applicant seeks an order declaring that it has ceased to
be an investment company. On September 30, 2016, applicant made a
liquidating distribution to its shareholders, based on net asset value.
Expenses of approximately $40,000 incurred in connection with the
liquidation were paid by the former sole shareholder of each series of
applicant. Applicant has retained a de minimis amount for the purpose
of completing certain regulatory and liquidation activities in China.
These de minimis amounts will be paid to the former sole shareholder of
each series of applicant.
    Filing Dates: The application was filed on October 20, 2016, and
amended on December 19, 2016 and January 5, 2017.
    Applicant's Address: Four Embarcadero Center, Suite 550, San
Francisco, California 94111.

The Wall Street Fund, Inc.

[File No. 811-00515]

    Summary: Applicant seeks an order declaring that it has ceased to
be an investment company. Applicant has transferred its assets to a
corresponding series of the Wall Street EWM Funds Trust and, on
September 30, 2014, made a final distribution to its shareholders based
on net asset value. Expenses of $74,844 incurred in connection with the
reorganization were paid by applicant and applicant's investment
adviser.
    Filing Date: The application was filed on December 20, 2016.
    Applicant's Address: 55 East 52nd Street, 23rd Floor, New York, New
York 10055.

Salient MLP Growth Fund

[File No. 811-22846]

    Summary: Applicant, a closed-end investment company, seeks an order
declaring that it has ceased to be an investment company. Applicant has
never made a public offering of its securities and does not propose to
make a public offering or engage in business of any kind.
    Filing Date: The application was filed on December 21, 2016.
    Applicant's Address: 4265 San Felipe, Suite 800, Houston, Texas
77027.

OneAmerica Funds, Inc.

[File No. 811-05850]

    Summary: Applicant seeks an order declaring that it has ceased to
be an investment company. On December 9, 2016, applicant made a
liquidating distribution to its shareholders, based on net asset value.
Expenses of approximately $276,282 incurred in connection with the
liquidation were paid by applicant's investment advisers.
    Filing Date: The application was filed on December 23, 2016.
    Applicant's Address: OneAmerican Square, Indianapolis, Indiana
46282.

First Trust Convertible Securities Income Fund

[File No. 811-23022]

    Summary: Applicant, a closed-end investment company, seeks an order
declaring that it has ceased to be an investment company. Applicant has
never made a public offering of its securities and does not propose to
make a public offering or engage in business of any kind.
    Filing Date: The application was filed on December 27, 2016.
    Applicant's Address: 120 East Liberty Drive, Suite 400, Wheaton,
Illinois 60187.

Calvert SAGE Fund

[File No. 811-22212]

    Summary: Applicant seeks an order declaring that it has ceased to
be an investment company. The applicant has transferred its assets to
Calvert Equity Portfolio, a series of Calvert Social Investment Fund
and, on June 24, 2016, made a final distribution to its shareholders
based on net asset value. Expenses of approximately $116,963 incurred
in connection with the reorganization were paid by applicant and
applicant's investment adviser.
    Filing Date: The application was filed on December 30, 2016.
    Applicant's Address: 4550 Montgomery Avenue, Suite 1000N, Bethesda,
Maryland 20814.

SEI Liquid Asset Trust

[File No. 811-03231]

    Summary: Applicant seeks an order declaring that it has ceased to
be an investment company. On July 22, 2016, applicant made a
liquidating distribution to its shareholders, based on net asset value.
Expenses of approximately $79,758 incurred in connection with the
liquidation were paid by applicant.
    Filing Date: The application was filed on December 30, 2016.
    Applicant's Address: One Freedom Valley Drive, Oaks, Pennsylvania
19456.

CPG York Event Driven Strategies, LLC

[File No. 811-23085]

    Summary: Applicant, a closed-end investment company, seeks an order
declaring that it has ceased to be an investment company. Applicant has
never made a public offering of its securities and does not propose to
make a public offering or engage in business of any kind.
    Filing Date: The application was filed on December 30, 2016.
    Applicant's Address: c/o Central Park Advisers, LLC, 805 Third
Avenue, New York, New York 10022.

LMP Real Estate Income Fund Inc.

[File No. 811-21098]

    Summary: Applicant, a closed-end investment company, seeks an order
declaring that it has ceased to be an investment company. Applicant has
transferred its assets to Legg Mason Funds Trust and, on June 10, 2016,
made a final distribution to its shareholders based on net asset value.
Expenses of $635,553 incurred in connection with the reorganization
were paid by applicant and applicant's investment adviser.
    Filing Date: The application was filed on January 5, 2017.
    Applicant's Address: 620 Eighth Avenue, New York, New York 10018.

Western Asset Managed High Income Fund Inc.

[File No. 811-07396]

    Summary: Applicant, a closed-end investment company, seeks an order
declaring that it has ceased to be an investment company. Applicant has
transferred its assets to Western Asset High Income Opportunity Fund
Inc. and, on August 29, 2016, made a final distribution to its
shareholders based on net asset value. Expenses of $792,374 incurred in
connection with the reorganization were paid by applicant, applicant's
investment adviser, and the acquiring fund.
    Filing Date: The application was filed on January 5, 2017.
    Applicant's Address: 620 Eighth Avenue, New York, New York 10018.

Western Asset Global Partners Income Fund Inc.

[File No. 811-07994]

    Summary: Applicant, a closed-end investment company, seeks an order
declaring that it has ceased to be an investment company. Applicant has
transferred its assets to Western Asset Global High Income Fund Inc.
and, on August 29, 2016, made a final distribution to its shareholders
based on net asset value. Expenses of $637,448 incurred in connection
with the reorganization were paid by applicant, applicant's investment
adviser, and the acquiring fund.
    Filing Date: The application was filed on January 5, 2017.
    Applicant's Address: 620 Eighth Avenue, New York, New York 10018.

Endowment Institutional TEI Fund W, L.P.

[File No. 811-22465]

    Summary: Applicant, a closed-end investment company, seeks an order
declaring that it has ceased to be an investment company. On July 1,
2016, applicant made a liquidating distribution to its shareholders,
based on net asset value. No expenses were incurred in connection with
the liquidation.
    Filing Date: The application was filed on January 5, 2017.
    Applicant's Address: 4265 San Felipe, 8th Floor, Houston, Texas
77027.

American Funds Global High-Income Opportunities Fund

[File No. 811-22745]

    Summary: Applicant seeks an order declaring that it has ceased to
be an investment company. Applicant has

never made a public offering of its securities and does not propose to
make a public offering or engage in business of any kind.
    Filing Date: The application was filed on January 13, 2017.
    Applicant's Address: 6455 Irvine Center Drive, Irvine, California
92618.

GAI Aurora Opportunities Fund, LLC

[File No. 811-22516]

    Summary: Applicant, a closed-end investment company, seeks an order
declaring that it has ceased to be an investment company. The applicant
has transferred its assets to GAI Corbin Multi-Strategy Fund, LLC and,
on September 30, 2016, made a final distribution to its shareholders
based on net asset value. Expenses of $188,478 incurred in connection
with the reorganization were paid by applicant and the acquiring fund.
    Filing Date: The application was filed on January 23, 2017.
    Applicant's Address: 401 South Tryon Street, Charlotte, North
Carolina 28202.

    For the Commission, by the Division of Investment Management,
pursuant to delegated authority.
Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2017-02180 Filed 2-1-17; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 84, Number 203 (Monday, October 21, 2019)]
[Notices]
[Pages 56267-56270]
[FR Doc No: 2019-22834]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-87311; File No. SR-CBOE-2019-049]

Self-Regulatory Organizations; Cboe Exchange, Inc.; Notice of
Filing of Amendment No. 2 and Order Granting Accelerated Approval of a
Proposed Rule Change, as Modified by Amendment Nos. 1 and 2, To Make
Permanent Certain Options Market Rules That Are Linked to the Equity
Market Plan To Address Extraordinary Market Volatility

October 15, 2019.

I. Introduction

    On August 21, 2019, Cboe Exchange, Inc. (the ``Exchange'' or ``Cboe
Options'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change to make permanent certain options market rules
that are linked to the equity market Plan to Address Extraordinary
Market Volatility (the ``Plan''). The proposed rule change was
published for comment in the Federal Register on August 29, 2019.\3\ On
October 10, 2019, the Exchange filed Amendment No. 1 to the proposed
rule change.\4\ On October 11, 2019, the Exchange filed Amendment No. 2
to the proposed rule change, which amended and superseded the proposed
rule change, as modified by Amendment No. 1.\5\ On October 11, 2019,
pursuant to Section 19(b)(2) of the Act,\6\ the Commission designated a

longer period within which to approve the proposed rule change,
disapprove the proposed rule change, or institute proceedings to
determine whether to approve or disapprove the proposed rule change.\7\
The Commission received no comment letters on the proposed rule change.
This order approves the proposed rule change, as modified by Amendment
Nos. 1 and 2, on an accelerated basis.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 86744 (August 23,
2019), 84 FR 45565 (``Notice'').
    \4\ In Amendment No. 1, the Exchange revised the proposed rule
text to reflect rule numbering and organizational changes enacted by
separate proposed rule changes that became effective while the
instant proposal was pending before the Commission. Because
Amendment No. 1 is a technical amendment that does not materially
alter the substance of the proposed rule change or raise unique or
novel regulatory issues, it is not subject to notice and comment.
Amendment No. 1 to the proposed rule change is available at: https://www.sec.gov/comments/sr-cboe-2019-049/srcboe2019049-6279378-193288.pdf.
    \5\ In Amendment No. 2, the Exchange revised the proposal to
remove the aspect of the proposed rule change that would have
permitted current Rule 5.22--relating to market-wide trading halts
due to extraordinary market volatility--to operate on a permanent
basis. In Amendment No. 2, the Exchange notes that it intends to
submit a separate rule filing proposing to continue to allow Rule
5.22 to operate on a pilot basis. Amendment No. 2 to the proposed
rule change is available at: https://www.sec.gov/comments/sr-cboe-2019-049/srcboe2019049-6285845-193338.pdf.
    \6\ 15 U.S.C. 78s(b)(2).
    \7\ See Securities Exchange Act Release No. 87291. The
Commission extended the date by which the Commission shall approve
or disapprove the proposed rule change to October 18, 2019.
---------------------------------------------------------------------------

II. Description of the Proposal

    The Exchange proposes to make permanent certain options market
rules in connection with the Plan. In an attempt to address
extraordinary market volatility in NMS stocks, the national securities
exchanges and the Financial Industry Regulatory Authority, Inc. adopted
the Plan pursuant to Rule 608 of Regulation NMS under the Act.\8\
Following the initial adoption of the Plan, the Exchange adopted and
amended current Rule 5.21, Rule 5.22 \9\ and Interpretation and Policy
.01 to Rule 6.5 to address certain aspects of the options market that
it believed may be impacted by the operation of the Plan, and
implemented such rules on a pilot basis that has coincided with the
pilot period for the Plan. These rules are scheduled to expire on
October 18, 2019.\10\
---------------------------------------------------------------------------

    \8\ See Securities Exchange Act Release Nos. 64547 (May 25,
2011), 76 FR 31647 (June 1, 2011) and 67091 (May 31, 2012), 77 FR
33498 (June 6, 2012) (order approving the initial Plan, as amended,
on a pilot basis).
    \9\ The Exchange has determined not to propose to make the
provisions in Rule 5.22 permanent at this time. See supra note 5.
    \10\ See Securities Exchange Act Release No. 69328 (April 5,
2013), 78 FR 21642 (April 11, 2013) (SR-CBOE-2013-030) (``Options
Pilot Approval'') (order approving certain options rule changes to
coincide with the pilot period for the Plan, including Rule 5.21).
See also Amendment No. 1, supra note 4 (describing the relocation of
these rules to their current location in the Cboe Options rulebook).
---------------------------------------------------------------------------

    In order to codify changes to its rules in connection with the
Plan, the Exchange adopted Rule 5.21, which essentially serves as a
roadmap for the Exchange's universal changes due to the implementation
of the Plan.\11\ The Exchange also amended Rule 6.5 to modify its
obvious and catastrophic error rules in connection with the
implementation of the Plan.\12\ After the Plan was approved on a
permanent basis, the pilot periods in Rules 5.21, 5.22 and 6.5 were
extended until the close of business on October 18, 2019.\13\ The
Exchange now proposes to make these pilot periods permanent. The
Exchange is not proposing any additional or substantive changes to
Rules 5.21 or 6.5.\14\ At this time, the Exchange is not proposing to
make the pilot period in Rule 5.22 permanent.\15\
---------------------------------------------------------------------------

    \11\ See Options Pilot Approval, supra note 10, at 21643.
Specifically, Rule 5.21 includes rule changes in connection with
special handling for market orders, market-on-close orders, stop
orders, and stock-option orders; certain electronic order handling
features in a limit up-limit down state; the obvious error rules;
and market-maker to quoting requirements during a limit up-limit
down state.
    \12\ See id. at 21645. The amendments to Rule 6.5 were
originally adopted on a one-year pilot basis, which was later
extended to coincide with the pilot period for the Plan. See
Securities Exchange Act Release No. 76223 (October 22, 2015), 80 FR
66102 (October 28, 2015) (SR-CBOE-2015-097).
    \13\ See Securities Exchange Act Release Nos. 85623 (April 11,
2019), 84 FR 16086 (April 17, 2019) (order approving Amendment No.
18 to the Plan, which, among other things, allowed the Plan to
continue to operate on a permanent basis) and 85616 (April 11,
2019), 84 FR 16093 (April 17, 2019) (SR-CBOE-2019-020) (extending
the pilot periods in Rules 5.21 and 6.5 to October 18, 2019).
    \14\ According to the Exchange, it expects the other national
securities exchanges to also file similar proposals to make their
respective pilot programs permanent. See Notice, supra note 3, at
45566.
    \15\ See supra note 5.
---------------------------------------------------------------------------

    Interpretation and Policy .01 to Rule 6.5 currently provides that
options transactions executed while the underlying security was in a
limit or straddle state (as defined in the Plan) will not be subject to
review as an obvious or catastrophic error during a pilot period that
expires on October 18, 2019 (``Obvious Error Pilot'').\16\ A limit or
straddle state occurs when at least one side of the National Best Bid
(``NBB'') or National Best Offer (``NBO'' and, together with the NBB,
the ``NBBO'') is priced at a non-tradable level.\17\ Specifically, a
straddle state exists when the NBB is below the lower price band while
the NBO is within the price band or when the NBO is above the upper
price band and the NBB is within the band.\18\ A limit state occurs
when the NBO equals the lower price band (without crossing the NBB) or
the NBB equals the upper price band (without crossing the NBO).\19\
---------------------------------------------------------------------------

    \16\ Such transactions may still be reviewed on an Exchange
official's own motion pursuant to Rule 6.5(c)(3), or adjusted or
nullified pursuant to Rule 6.5(e)-(j) and Interpretation and Policy
.05. See Interpretation and Policy .01 to Rule 6.5.
    \17\ See Notice, supra note 3, at 45565. Pursuant to the Plan,
each NMS stock is subject to a lower price band and a higher price
band, designed to prevent trades in individual NMS stocks from
occurring outside of the specified price bands. See Options Pilot
Approval, supra note 10, at 21642.
    \18\ See Notice, supra note 3, at 45565.
    \19\ See id.
---------------------------------------------------------------------------

    Pursuant to Rule 6.5, the determination of the theoretical price of
an option, which is used to determine whether to adjust or nullify an
options transaction subject to obvious or catastrophic error review,
generally references the NBB (for erroneous sell transactions) or NBO
(for erroneous buy transactions) just prior to the trade in question.
The Exchange states that this process is not reliable when at least one
side of the NBBO is priced at a non-tradeable level, as is the case
during limit and straddle states.\20\ According to the Exchange, when
an underlying security is in a limit or straddle state, there will not
be a reliable price for the security to serve as a benchmark for the
price of the option and, therefore, the application of the obvious and
catastrophic error rules would be impracticable given the potential for
the lack of a reliable NBBO in the options market during such limit or
straddle state.\21\
---------------------------------------------------------------------------

    \20\ See id.
    \21\ See id.
---------------------------------------------------------------------------

    During the course of the Obvious Error Pilot, the Exchange has
provided, to the Commission and the public, data for each limit and
straddle state in optionable stocks that had at least one trade on the
Exchange.\22\ In addition, the Exchange has provided, to the Commission
and the public, assessments relating to the impact of the operation of
the obvious error rules during limit and straddle states, including:
(1) An evaluation of the statistical and economic impact of limit and
straddle states on liquidity and market quality in the options markets;
and (2) an assessment of whether the lack of obvious error rules in
effect during the limit and straddle states are problematic. The
Exchange states that, during its most recent review period, the
Exchange did not receive any obvious error review requests for limit-
up-limit down trades, and limit up-limit down trade volume accounted
for nominal overall trade volume.\23\ Accordingly, and based on the
data made available to the Commission and the public during the pilot
period, the Exchange believes that the Obvious

Error Pilot does not negatively impact market quality during normal
market conditions.\24\ The Exchange also concluded that there has been
insufficient data to assess whether a lack of obvious error rules is
problematic.\25\ However, the Exchange believes the continuation of
Interpretation and Policy .01 to Rule 6.5 would protect against any
unanticipated consequences and add certainty in the options markets
during a limit or straddle state.\26\
---------------------------------------------------------------------------

    \22\ See Cboe Global Markets, LULD Limit and Straddle Reports,
available at http://markets.cboe.com/us/options/market_statistics/luld_reports/?mkt=opt. For each trade on the Exchange, the Exchange
has provided: (a) The stock symbol, the option symbol, the time at
the start of the limit or straddle state, and an indicator for
whether it is a limit or straddle state; and (b) the executed
volume, the time-weighted quoted bid-ask spread, the time-weighted
average quoted depth at the bid, the time-weighted average quoted
depth at the offer, the high execution price, the low execution
price, the number of trades for which a request for review for error
was received during limit and straddle states, and an indicator
variable for whether those options outlined above have a price
change exceeding 30% during the underlying stock's limit or straddle
state compared to the last available option price as reported by
OPRA before the start of the limit or straddle state.
    \23\ See Notice, supra note 3, at 45566 n.9.
    \24\ See id. at 45566.
    \25\ See id.
    \26\ See id.
---------------------------------------------------------------------------

III. Discussion and Commission Findings

    After careful review, the Commission finds that the proposed rule
change, as modified by Amendments No. 1 and 2, is consistent with the
requirements of the Act and the rules and regulations thereunder
applicable to a national securities exchange.\27\ In particular, the
Commission finds that the proposed rule change is consistent with
Section 6(b)(5) of the Act,\28\ which requires, among other things,
that the rules of a national securities exchange be designed to prevent
fraudulent and manipulative acts and practices, to promote just and
equitable principles of trade, to foster cooperation and coordination
with persons engaged in facilitating transactions in securities, to
remove impediments to and perfect the mechanism of a free and open
market and a national market system, and, in general, to protect
investors and the public interest.
---------------------------------------------------------------------------

    \27\ In approving this proposed rule change, the Commission has
considered the proposed rule's impact on efficiency, competition,
and capital formation. See 15 U.S.C. 78c(f).
    \28\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    In the Options Pilot Approval, the Commission noted the potential
inequity of nullifying or adjusting executions occurring during limit
or straddle states due to the lack of a reliable NBBO.\29\ At the same
time, the Commission expressed concern about the potential impact on
investors during limit and straddle states without the protections of
the obvious or catastrophic error rules.\30\ However, in the same
order, the Commission also highlighted certain aspects of the
Exchange's proposal that could help mitigate those concerns.
Specifically, the Exchange stated that there are additional measures in
place designed to protect investors, despite the removal of obvious and
catastrophic error protection during limit and straddle states.\31\ For
example, the Exchange stated that by rejecting market orders and not
triggering stop orders, only those orders with a limit price will be
executed during a limit or straddle state.\32\ Additionally, the
Exchange noted the existence of Rule 15c3-5 under the Act,\33\
requiring broker-dealers to have controls and procedures in place that
are reasonably designed to prevent the entry of erroneous orders.\34\
Further, the Commission stressed the importance of placing the proposal
on a pilot and requesting data to allow the Commission to further
evaluate the effect of the proposal prior to any determination to make
such changes permanent.\35\
---------------------------------------------------------------------------

    \29\ See Options Pilot Approval, supra note 10, at 21645, 21647.
    \30\ See id. at 21647.
    \31\ See id.
    \32\ See id. See also Rule 5.32(c)(5).
    \33\ 17 CFR 240.15c3-5.
    \34\ See Options Pilot Approval, supra note 10, at 21647.
    \35\ See id. at 21647-48.
---------------------------------------------------------------------------

    Under the terms of the Options Pilot Approval, the Exchange
provided the Commission and the public with data and assessments
relating to the impact of the operation of the obvious and catastrophic
error rules during limit and straddle states.\36\ The Commission notes
that, as described above, the Exchange stated that it did not receive
any obvious error review requests for limit up-limit down trades during
its most recent review period.\37\ Accordingly, based on the data from
the Exchange and in light of the additional measures in place designed
to protect investors, despite the removal of obvious and catastrophic
error protection during limit and straddle states, the Commission
believes it is appropriate to permit the Obvious Error Pilot to operate
on a permanent basis.
---------------------------------------------------------------------------

    \36\ See supra note 22.
    \37\ See Notice, supra note 3, at 45566 n.9.
---------------------------------------------------------------------------

IV. Solicitation of Comments on Amendment No. 2 to the Proposed Rule
Change

    Interested persons are invited to submit written data, views, and
arguments concerning whether Amendment No. 2 is consistent with the
Act. Comments may be submitted by any of the following methods:

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-CBOE-2019-049 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-CBOE-2019-049. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549, on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-CBOE-2019-049, and should be submitted
on or before November 12, 2019.

V. Accelerated Approval of Proposed Rule Change, as Modified by
Amendment Nos. 1 and 2

    The Commission finds good cause to approve the proposed rule
change, as modified by Amendment Nos. 1 and 2, prior to the thirtieth
day after the date of publication of notice of the filing of Amendment
No. 2 in the Federal Register. As discussed above, in Amendment No. 2,
the Exchange revised the proposal to remove the aspect of the proposed
rule change that would permit current Rule 5.22 to operate on a
permanent basis. The Commission believes that Amendment No. 2 does not
raise any novel regulatory issues. Instead, it removes one aspect of
the proposed rule change that does not alter remaining aspects of the
proposal, which was subject to a full

notice and comment period during which no comments were received. The
Commission also notes that, according to the Exchange, it intends to
submit a separate rule filing proposing to continue to allow Rule 5.22
to operate on a pilot basis.\38\ Accordingly, the Commission finds good
cause, pursuant to Section 19(b)(2) of the Act,\39\ to approve the
proposed rule change, as modified by Amendment Nos. 1 and 2, on an
accelerated basis.
---------------------------------------------------------------------------

    \38\ See Amendment No. 2, supra note 5.
    \39\ 15 U.S.C. 78s(b)(2).
---------------------------------------------------------------------------

VI. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\40\ that the proposed rule change (SR-CBOE-2019-049), as modified
by Amendment Nos. 1 and 2, be, and hereby is, approved on an
accelerated basis.
---------------------------------------------------------------------------

    \40\ Id.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\41\
---------------------------------------------------------------------------

    \41\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2019-22834 Filed 10-18-19; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 85, Number 199 (Wednesday, October 14, 2020)]
[Rules and Regulations]
[Pages 64969-64971]
[FR Doc No: 2020-20831]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R01-OAR-2020-0284; FRL-10014-81-Region 1]

Air Plan Approval; Maine; Midcoast Area and Portland Second 10-
Year Limited Maintenance Plans for 1997 Ozone NAAQS

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: Pursuant to the Clean Air Act (CAA), the Environmental
Protection Agency (EPA) is approving a state implementation plan (SIP)
revision submitted by the State of Maine. On February 18, 2020, the
State submitted its 1997 ozone national ambient air quality standards
(NAAQS) Limited Maintenance Plans (LMPs) for the Portland and Midcoast
areas. EPA is approving the Portland and Midcoast LMPs because they
provide for the maintenance of the 1997 ozone NAAQS through the end of
the second 10-year portion of the maintenance period. The effect of
this action will be to make certain commitments related to maintenance
of the 1997 ozone NAAQS in the Portland and Midcoast maintenance areas
part of the Maine SIP and therefore federally enforceable.

DATES: This rule is effective on November 13, 2020.

ADDRESSES: EPA has established a docket for this action under Docket
Identification No. EPA-R01-OAR-2020-0284. All documents in the docket
are listed on the https://www.regulations.gov website. Although listed
in the index, some information is not publicly available, i.e., CBI or
other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
internet and will be publicly available only in hard copy form.
Publicly available docket materials are available at https://www.regulations.gov or at the U.S. Environmental Protection Agency, EPA
Region 1 Regional Office, Air and Radiation Division, 5 Post Office
Square--Suite 100, Boston, MA. EPA requests that if at all possible,
you contact the contact listed in the FOR FURTHER INFORMATION CONTACT
section to schedule your inspection. The Regional Office's official
hours of business are Monday through Friday, 8:30 a.m. to 4:30 p.m.,
excluding legal holidays and facility closures due to COVID-19.

FOR FURTHER INFORMATION CONTACT: Eric Rackauskas, Air Quality Branch,
U.S. Environmental Protection Agency, EPA Region 1, 5 Post Office
Square--Suite 100, (Mail code 05-2), Boston, MA 02109-3912, tel. 617-
918-1628, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we,''
``us,'' or ``our'' is used, we mean EPA.

Table of Contents

I. Background and Purpose
II. Final Action
III. Statutory and Executive Order Reviews

I. Background and Purpose

    Under the CAA, EPA is approving Limited Maintenance Plans (LMPs)
for the Portland and Midcoast maintenance areas for the 1997 ozone
NAAQS submitted as a revision to the Maine State Implementation Plan
(SIP) on February 18, 2020. The Portland area under the 1997 ozone
NAAQS is comprised of 57 cities and towns in York, Cumberland and
Sagadahoc Counties along with Durham, Maine in Androscoggin County. The
Midcoast area is made up of 55 coastal towns and islands in Hancock,
Knox, Lincoln and Waldo counties. On June 15, 2004, the Portland and
Midcoast areas were designated as nonattainment areas under the 1997
ozone NAAQS. On January 10, 2007, the areas were redesignated to
attainment under that standard.
    The Portland and Midcoast areas' LMPs for the 1997 ozone NAAQS
submitted by Maine are designed to maintain the 1997 ozone NAAQS within
these areas through the end of the second ten-year period of the
maintenance period. We are approving the plans because they meet all
applicable requirements under CAA sections 110 and 175A.
    Other specific requirements of the LMPs and the rationale for EPA's
proposed action are explained in the notice of proposed rulemaking and
will not be restated here. EPA received two public comments during the
comment period for the notice of proposed rulemaking. One comment
supported the action. The second comment was not germane to the
rulemaking notice, did not indicate any technical or legal reason why
EPA should not approve the SIP revision, and did not propose any
changes to the SIP revision.

II. Final Action

    EPA is approving, and incorporating into the Maine SIP, the 1997
ozone national ambient air quality standards LMPs for the Portland and
Midcoast areas. EPA is approving the LMPs because the plans are
consistent with the requirements of the CAA.

III. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Act and
applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act.
Accordingly, this action merely approves state law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by state law. For that reason, this action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735,

October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     Is not an Executive Order 13771 regulatory action because
this action is not significant under Executive Order 12866;
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where EPA or an Indian tribe has
demonstrated that a tribe has jurisdiction. In those areas of Indian
country, the rule does not have tribal implications and will not impose
substantial direct costs on tribal governments or preempt tribal law as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by December 14, 2020. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this action for the purposes of
judicial review nor does it extend the time within which a petition for
judicial review may be filed, and shall not postpone the effectiveness
of such rule or action. This action may not be challenged later in
proceedings to enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide,
Incorporation by reference, Intergovernmental relations, Lead, Nitrogen
dioxide, Ozone, Particulate matter, Reporting and recordkeeping
requirements, Sulfur oxides, Volatile organic compounds.

    Dated: September 14, 2020.
Dennis Deziel,
Regional Administrator, EPA Region 1.

    Part 52 of chapter I, title 40 of the Code of Federal Regulations
is amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

    Authority: 42 U.S.C. 7401 et seq.

Subpart U--Maine

0
2. In Sec.  52.1020(e), amend the table by adding the entries
``Portland Area Second 10-Year Limited Maintenance Plans for 1997 Ozone
NAAQS'' and ``Midcoast Area Second 10-Year Limited Maintenance Plans
for 1997 Ozone NAAQS'', at the end of the table, to read as follows:

Sec.  52.1020  Identification of plan.

* * * * *
    (e) * * *

                                              Maine Non Regulatory
----------------------------------------------------------------------------------------------------------------
                                        Applicable           State
    Name of non regulatory SIP        geographic or     submittal date/  EPA approved date       Explanations
            provision               nonattainment area  effective date          \3\
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Portland Area Second 10-Year       Portland Area......       2/18/2020  10/14/2020 [Insert   2nd maintenance
 Limited Maintenance Plans for                                           Federal Register     plan for 1997
 1997 Ozone NAAQS.                                                       citation].           ozone standard.
Midcoast Area Second 10-Year       Midcoast area......       2/18/2020  10/14/2020 [Insert   2nd maintenance
 Limited Maintenance Plans for                                           Federal Register     plan for 1997
 1997 Ozone NAAQS.                                                       citation].           ozone standard.
----------------------------------------------------------------------------------------------------------------
\3\ In order to determine the EPA effective date for a specific provision listed in this table, consult the
  Federal Register notice cited in this column for the particular provision.

[FR Doc. 2020-20831 Filed 10-13-20; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 81, Number 26 (Tuesday, February 9, 2016)]
[Notices]
[Pages 6867-6868]
[FR Doc No: 2016-02516]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0395]

Recommendations for Premarket Notifications for Lamotrigine and
Zonisamide Assays; Guidance for Industry and Food and Drug
Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the guidance entitled ``Recommendations for Premarket
Notifications for Lamotrigine and Zonisamide Assays.'' This guidance
document discusses information to be included in premarket
notifications for zonisamide or lamotrigine assays.

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

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2010-D-0395 for ``Recommendations for Premarket Notifications for
Lamotrigine and Zonisamide Assays; Guidance for Industry and Food and
Drug Administration Staff; Availability.'' Received comments will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at http://www.regulations.gov or at
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
    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 guidance document entitled
``Recommendations for Premarket Notifications for Lamotrigine and
Zonisamide Assays'' to the Office of the Center Director, Guidance and
Policy Development, 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: Courtney Lias, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave. Bldg. 66, Rm. 4626, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is issuing this guidance document to describe its current
thinking concerning issues that should be addressed in premarket
notifications for assays intended to quantitate the anti-seizure drugs
lamotrigine and zonisamide in serum. Some of the general concepts in
this guidance may also be helpful in preparing 510(k) submissions for
other therapeutic drug assays previously cleared by FDA, and classified
within 21 CFR 862, subpart D. The draft guidance was available for
comment on August 6, 2010. The comment period closed on November 4,
2010. No comments relating to the specific recommendation in the
guidance were received. Minor revisions to the guidance have been made
for clarifications and updates.

II. Significance of Guidance

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

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by
downloading an electronic copy from the Internet. A search capability
for all Center for Devices and Radiological Health guidance documents
is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at http://www.regulations.gov. Persons
unable to download an electronic copy of ``Recommendations for
Premarket Notifications for Lamotrigine and Zonisamide Assays,'' may
send an email request to<EMAIL_ADDRESS>to receive an
electronic copy of the document. Please use the document number 1654 to
identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information addressed in the guidance document have been
approved by OMB in accordance with the PRA under the regulations
governing premarket notification submissions (21 CFR part 807, subpart
E, OMB Control No. 0910-0120). The labeling provisions addressed in the
guidance have been approved by OMB Control No. 0910-0485.

V. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

    Dated: February 4, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-02516 Filed 2-8-16; 8:45 am]
 BILLING CODE 4164-01-P