[Federal Register Volume 84, Number 42 (Monday, March 4, 2019)]
[Rules and Regulations]
[Pages 7288-7290]
[FR Doc No: 2019-03832]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2019-0127]
RIN 1625-AA00

Safety Zone; Cumberland River, Kentucky

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary safety zone for
all navigable waters between mile marker 0.0 and mile marker 3.0 of the
Cumberland River in Smithland, Kentucky. The safety zone is needed to
protect personnel, vessels, and personal property from potential
hazards created by vessel wake during a high water event. Entry of
vessels or persons into this zone is prohibited unless specifically
authorized by the Captain of the Port Sector Ohio Valley or a
designated representative.

DATES: This rule is effective without actual notice from March 4, 2019
until March 15, 2019. For the purposes of enforcement, actual notice
will be used from February 26, 2019 until March 4, 2019. This rule will
be enforced from February 26, 2019 to March 15, 2019, unless the lower
gauge at Smithland Lock and Dam falls below 50 feet, in which case the
enforcement of this rule will be terminated.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to https://www.regulations.gov, type USCG-
2019-0127 in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email MST2 Dylan Caikowski, Marine Safety Unit Paducah, U.S.
Coast Guard; telephone<PHONE_NUMBER> ext. 2120, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
COTP Captain of the Port Sector Ohio Valley
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background Information and Regulatory History

    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because it is impracticable. We must
establish this emergency safety zone by February 26, 2019 to ensure the
safety of residents and the protection of personal property near the
riverfront in Smithland, Kentucky during a high water event.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Delaying the effective date of
this rule would be contrary to the public interest because delaying the
effective period will compromise the safety of residents, vessels, and
personal property near the riverfront of Smithland, Kentucky during a
high water event.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 46 U.S.C.
70034. The Captain of the Port Sector Ohio Valley (COTP) has determined
a safety zone is needed to protect personnel, vessels, and personal
property from potential hazards created by vessel wake during a high
water event.

IV. Discussion of the Rule

    This rule establishes a safety zone from February 26, 2019 to March
15, 2019 or when the lower gauge at Smithland Lock and Dam falls below
50 feet, whichever occurs first. The safety zone will cover all
navigable waters between mile marker 0.0 and mile marker 3.0 of the
Cumberland River in Smithland, Kentucky. The duration of the zone is
intended to protect personnel, vessels, and the personal property in
these navigable waters during the high water event. No vessel or person
will be permitted to enter the safety zone without obtaining permission
from the COTP or a designated representative. The COTP or a designated
representative will inform the public through broadcast notices to
mariners of any changes in the planned schedule.

V. Regulatory Analyses

    We developed this rule after considering numerous statutes and
Executive orders related to rulemaking. Below we summarize our analyses
based on a number of these statutes and Executive orders, and we
discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive Order 13771 directs agencies to control
regulatory costs through a budgeting process. This rule has not

been designated a ``significant regulatory action,'' under Executive
Order 12866. Accordingly, this rule has not been reviewed by the Office
of Management and Budget (OMB), and pursuant to OMB guidance it is
exempt from the requirements of Executive Order 13771.
    This regulatory action determination is based on the size,
duration, and location of the safety zone. This safety zone will only
be enforced for 18 days on a three-mile stretch of the Cumberland River
near Smithland, Kentucky, while the area is experiencing a high water
event. The enforcement of the zone will be terminated once the lower
gauge at Smithland Lock and Dam falls below 50 feet, whichever occurs
first. While entry is prohibited, vessels may request permission from
the COTP or a designated representative to enter the zone.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
will not have a significant economic impact on a substantial number of
small entities.
    While some owners or operators of vessels intending to transit the
temporary safety zone may be small entities, for the reasons stated in
section V.A above, this rule will not have a significant economic
impact on any vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this rule under that Order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes. If
you believe this rule has implications for federalism or Indian tribes,
please contact the person listed in the FOR FURTHER INFORMATION CONTACT
section above.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Directive 023-01 and Commandant Instruction M16475.1D, which guide the
Coast Guard in complying with the National Environmental Policy Act of
1969 (42 U.S.C. 4321-4370f), and have determined that this action is
one of a category of actions that do not individually or cumulatively
have a significant effect on the human environment. This rule involves
a temporary safety zone that will cover all navigable waters between
mile marker 0.0 and mile marker 3.0 of the Cumberland River in
Smithland, Kentucky. The safety zone is intended to protect personnel,
vessels, and personal property in these navigable waters during a high
water event. It is categorically excluded from further review under
paragraph L60(a) of Appendix A, Table 1 of DHS Instruction Manual 023-
01-001-01, Rev. 01. A Record of Environmental Consideration supporting
this determination is available in the docket where indicated under
ADDRESSES.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and record
keeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority: 46 U.S.C. 70034; 46 U.S.C. 70051; 33 CFR 1.05-1;
6.04-1, 6.04-6, and 160.5; Department of Homeland Security
Delegation No. 0170.1.

0
2. Add Sec.  165.T08-0127 to read as follows:

Sec.  165.T08-0127  Safety Zone; Cumberland River, Smithland, KY.

    (a) Location. The safety zone will encompass all waters of the
Cumberland River between mile marker 0.0 and mile marker 3.0.
    (b) Effective dates. This section is effective without actual
notice from March 4, 2019 until March 15, 2019. For the purposes of
enforcement, actual notice will be used from February 26, 2019 until
March 4, 2019.

    (c) Period of enforcement. This section will be enforced from
February 26, 2019 to March 15, 2019, unless the lower gauge at
Smithland Lock and Dam falls below 50 feet, in which case the
enforcement of this rule will be terminated.
    (d) Regulations. (1) In accordance with the general regulations in
Sec.  165.23 of this part, entry into this safety zone is prohibited
unless authorized by the Captain of the Port Sector Ohio Valley (COTP)
or a designated representative.
    (2) Persons or vessels desiring entry to or passage through the
safety zone must request permission from the COTP or a designated
representative. They may be contacted on VHF-FM channel 16 or by
telephone at<PHONE_NUMBER>.
    (3) If permission is granted, all persons and vessels shall comply
with the instructions of the COTP or designated representative.
    (e) Informational broadcasts. The COTP or a designated
representative will inform the public through broadcast notices to
mariners of any changes in the planned schedule.

    Dated: February 26, 2019.
M.B. Zamperini,
Captain, U.S. Coast Guard, Captain of the Port Sector Ohio Valley.
[FR Doc. 2019-03832 Filed 3-1-19; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register: February 29, 2008 (Volume 73, Number 41)]
[Notices]
[Page 11173-11177]
[DOCID:fr29fe08-129]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-57358; File No. SR-NYSEArca-2008-17]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Create a Delta
Hedging Exemption From Equity Options Position Limits

February 20, 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 February 6, 2008, NYSE Arca, Inc. (``NYSE Arca'' or ``Exchange'')
filed with the Securities and Exchange Commission (``Commission'') the
proposed rule change as described in Items I and II

below, which Items have been substantially prepared by NYSE Arca. The
Exchange has filed the proposal as a ``non-controversial'' rule change
pursuant to Section 19(b)(3)(A) of the Act \3\ and Rule 19b-4(f)(6)
thereunder,\4\ which renders it effective upon filing with the
Commission. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
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    \1\15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\15 U.S.C. 78s(b)(3)(A).
    \4\ 17 CFR 240.19b-4(f)(6).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    NYSE Arca proposes to amend Exchange Rule 6.8 in order to create a
delta hedging exemption from equity options position limits. The text
of the proposed rule change is available at NYSE Arca, the Commission's
Public Reference Room, and http://www.nysearca.com.

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

    In its filing with the Commission, NYSE Arca 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. NYSE Arca 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
    All options traded on the Exchange are subject to position and
exercise limits, as provided under NYSE Arca Rule 6.8.\5\ Position
limits are imposed, generally, to maintain fair and orderly markets for
options and other securities by limiting the amount of control by one
or more affiliated persons or entities over one particular options
class or the security or securities that underlie that options class.
Exchange rules also contain various hedge exemptions to allow certain
hedged positions in excess of the applicable standard position
limit.\6\
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    \5\ Position limits for index options are provided separately
under NYSE Arca Rule 5.15 through Rule 5.17.
    \6\ See NYSE Arca Rule 6.8 Commentary .07-.08.
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    Over the years, NYSE Arca has, at times, increased the size of
options position and exercise limits, as well as the size and scope of
available hedge exemptions to the applicable position limits.\7\ These
hedge exemptions generally require a one-to-one hedge (i.e., one stock
option contract must be hedged by the number of shares underlying the
options contract, typically 100 shares). In practice, however, many
firms do not hedge their options positions in this manner. Instead,
these firms engage in what is commonly known as ``delta hedging.''
Delta hedging varies the number of shares of the underlying security
used to hedge an options position based upon the relative sensitivity
of the value of the option contract to a change in the price of the
underlying security.\8\ The Exchange believes that delta hedging is a
widely accepted method for risk management.
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    \7\ See Securities Exchange Act Release Nos. 55347 (February 26,
2007), 72 FR 9823 (March 5, 2007) (SR-NYSEArca-2007-19); 54385
(August 30, 2006), 71 FR 53150 (September 8, 2006) (SR-NYSEArca-
2006-49); 51286 (March 1, 2005) 70 FR 11297 (SR-PCX-2003-55); and
45737 (April 11, 2005), 67 FR 18975 (SR-PCX-2000-45).
    \8\ To illustrate, a stock option contract with a delta of .5
will move $0.50 for every $1.00 move in the underlying stock.
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    Delta Neutral-Based Equity Hedge Exemption. The Exchange proposes
to adopt a new exemption from equity options position and exercise
limits \9\ for positions held by NYSE Arca OTP Holders and OTP
Firms,\10\ and certain of their affiliates, that are ``delta neutral''
\11\ under a ``permitted pricing model'' (as defined below), subject to
certain conditions (``Exemption''). The proposed Exemption would apply
only to equity options (stock options and options on exchange-traded
funds (``ETFs'')).\12\
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    \9\ NYSE Arca Rule 6.9 establishes exercise limits for an option
at the same level as the option's position limit under NYSE Arca
Rule 6.8; therefore, no changes are proposed to Rule 6.9.
    \10\ OTP Holders (NYSE Arca Rule 1.1(q)) and OTP Firms (NYSE
Arca Rule 1.1(r)) have the status of a ``member'' of the Exchange as
defined in Section 3 of the Act, 15 U.S.C. 78c.
    \11\ The term ``delta neutral'' is defined in proposed Rule 6.8
Commentary .09(a) as referring to an equity option position that is
hedged, in accordance with a permitted pricing model, by a position
in the underlying security or one or more instruments relating to
the underlying security, for the purpose of offsetting the risk that
the value of the option position will change with incremental
changes in the price of the security underlying the option position.
    \12\ The Exchange intends to submit a separate proposed rule
change to adopt a delta neutral-based hedge exemption for certain
index options and to expand the delta neutral-based hedge exemption
for ETF options to allow highly correlated instruments to be
included in any ETF option net delta calculation.
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    Any equity option position that is not delta neutral would be
subject to position and exercise limits, subject to the availability of
other exemptions. Only the ``option contract equivalent of the net
delta'' of such position would be subject to the appropriate position
limit.\13\
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    \13\ Under proposed Rule 6.8 Commentary .09(b) the term
``options contract equivalent of the net delta'' is defined as the
net delta divided by the number of shares underlying the option
contract, and the term ``net delta'' is defined as, at any time, the
number of shares (either long or short) required to offset the risk
that the value of an equity option position will change with
incremental changes in the price of the security underlying the
option position, as determined in accordance with a permitted
pricing model.
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    Only financial instruments relating to the security underlying an
equity options position could be included in any determination of an
equity options position's net delta or whether the options position is
delta neutral. In addition, members could not use the same equity or
other financial instrument position in connection with more than one
hedge exemption. Therefore, a stock position used as part of a delta
hedging strategy could not also serve as the basis for any other equity
hedge exemption.
    Permitted Pricing Model. Under the proposed rule, the calculation
of the delta for any equity option position, and the determination of
whether a particular equity option position is delta neutral, must be
made using a permitted pricing model. A ``permitted pricing model'' is
defined in proposed Rule 6.8 Commentary .09(c) to mean the pricing
model maintained and operated by The Options Clearing Corporation
(``OCC'') and the pricing models used by: (i) An OTP Holder or OTP Firm
or its affiliate subject to consolidated supervision by the Commission
pursuant to Appendix E of Rule 15c3-1 under the Act; (ii) a financial
holding company (``FHC'') or a company treated as an FHC under the Bank
Holding Company Act of 1956, or its affiliate subject to consolidated
holding company group supervision; \14\

(iii) a Commission-registered OTC derivatives dealer; \15\ and (iv) a
national bank.\16\
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    \14\ The pricing model of an FHC or of an affiliate of an FHC
would have to be consistent with: (i) The requirements of the Board
of Governors of the Federal Reserve System (``FRB''), as amended
from time to time, in connection with the calculation of risk-based
adjustments to capital for market risk under capital requirements of
the FRB, provided that the OTP Holder or OTP Firm (or affiliate
thereof) relying on this exemption in connection with the use of
such model is an entity that is part of such company's consolidated
supervised holding company group; or (ii) the standards published by
the Basel Committee on Banking Supervision, as amended from time to
time and as implemented by such company's principal regulator, in
connection with the calculation of risk-based deductions or
adjustments to or allowances for the market risk capital
requirements of such principal regulator applicable to such
company--where ``principal regulator'' means a member of the Basel
Committee on Banking Supervision that is the home country
consolidated supervisor of such company--provided that the OTP
Holder or OTP Firm (or affiliate thereof) relying on this exemption
in connection with the use of such model is an entity that is part
of such company's consolidated supervised holding company group. See
subsection (c)(3) of proposed Rule 6.8 Commentary .09.
    \15\ The pricing model of a Commission-registered OTC
derivatives dealer would have to be consistent with the requirements
of Appendix F to Rules 15c3-1 and 15c3-4 under the Act, as amended
from time to time, in connection with the calculation of risk-based
deductions from capital for market risk thereunder. Only an OTC
derivatives dealer and no other affiliated entity (including an OTP
Holder or OTP Firm) would be able to rely on this part of the
Exemption. See subsection (c)(4) of proposed Rule 6.8 Commentary
.09.
    \16\ The pricing model of a national bank would have to be
consistent with the requirements of the Office of the Comptroller of
the Currency, as amended from time to time, in connection with the
calculation of risk-based adjustments to capital for market risk
under capital requirements of the Office of the Comptroller of the
Currency. Only a national bank and no other affiliated entity
(including an OTP Holder or OTP Firm) would be able to rely on this
part of the Exemption. See subparagraph (c)(5) of proposed Rule 6.8
Commentary .09.
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    Aggregation of Accounts. An OTP Holder or OTP Firm (or an affiliate
thereof) relying on the Exemption would be required to ensure that the
permitted pricing model is applied to all positions in or relating to
the security underlying the relevant options position that are owned or
controlled by the OTP Holder or OTP Firm, or its affiliate.
    However, the net delta of an options position held by an entity
entitled to rely on the Exemption, or by a separate and distinct
trading unit of such entity, may be calculated without regard to
positions in or relating to the security underlying the option position
held by an affiliated entity or by another trading unit within the same
entity, provided that: (i) The entity demonstrates to the Exchange's
satisfaction that no control relationship \17\ exists between such
affiliates or trading units; and (ii) the entity has provided the
Exchange written notice in advance that it intends to be considered
separate and distinct from any affiliate, or, as applicable, which
trading units within the entity are to be considered separate and
distinct from each other for purposes of the Exemption.\18\
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    \17\ For purposes of the proposed rule, ``control'' is as
defined in Position and Exercise Limits, NYSE Arca Regulatory
Bulletin RBO-07-08 (August 31, 2007).
    \18\ See subsection (d) of proposed Rule 6.8 Commentary .09.
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    The Exchange has previously set forth in a regulatory bulletin the
conditions under which it will deem control exists between affiliated
broker dealers and between separate and distinct trading units within
the same broker-dealer.\19\ The Exchange will also issue a subsequent
regulatory bulletin, explaining the aggregation of accounts, for the
purpose of position limits, for broker-dealers and their non-broker
dealer affiliates. The Exchange will issue this bulletin prior to the
operative date of this rule change.
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    \19\ See supra note 17.
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    Any OTP Holder or OTP Firm (or affiliate thereof) relying on the
Exemption must designate, by prior written notice to the Exchange, each
trading unit or entity whose options positions are required by Exchange
rules to be aggregated with the options positions of such OTP Holder or
OTP Firm (or affiliate thereof) relying on the Exemption for purposes
of compliance with Exchange position or exercise limits.\20\
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    \20\ See subparagraph (d)(3) of proposed Rule 6.8 Commentary
.09.
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    Obligations of OTP Holders and OTP Firms (and affiliates thereof).
Any OTP Holder or OTP Firm relying on the Exemption would be required
to provide a written certification to the Exchange that it is using a
permitted pricing model as defined in the rule for purposes of the
Exemption. In addition, by such reliance, such OTP Holder or OTP Firm
would authorize any other person carrying for such OTP Holder or OTP
Firm an account including, or with whom such OTP Holder or OTP Firm has
entered into, a position in or relating to a security underlying the
relevant option position to provide to the Exchange or OCC such
information regarding such account or position as the Exchange or OCC
may request as part of the Exchange's confirmation or verification of
the accuracy of any net delta calculation under this Exemption.\21\
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    \21\ See subsection (e) of proposed Rule 6.8 Commentary .09.
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    The options positions of a non-OTP Holder or Firm affiliate,
relying on the Exemption must be carried by an OTP Holder or OTP Firm
with which it is affiliated. An OTP Holder or OTP Firm carrying an
account that includes an equity option position for an affiliate that
intends to rely on the Exemption would be required to obtain from such
affiliate a written certification that it is using a permitted pricing
model as defined in the rule for purposes of the Exemption.\22\
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    \22\ In addition, the OTP Holder or OTP Firm would be required
to obtain from such affiliate a written statement confirming that
such affiliate: (a) Is relying on the Exemption; (b) will use only a
permitted pricing model for purposes of calculating the net delta of
its option positions for purposes of the Exemption; (c) will
promptly notify the affiliated OTP Holder or OTP Firm if it ceases
to rely on the Exemption; (d) authorizes the OTP Holder or OTP Firm
to provide to the Exchange or the OCC such information regarding
positions of the affiliate as the Exchange or OCC may request as
part of the Exchange's confirmation or verification of the accuracy
of any net delta calculation under the Exemption; and (e) if the
affiliate is using the OCC Model, has duly executed and delivered to
the Exchange such documents as the Exchange may require to be
executed and delivered to the Exchange as a condition to reliance on
the Exemption. See subparagraph (e)(3) of proposed Rule 6.8
Commentary .09.
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    Reporting. Under proposed Rule 6.8 Commentary .09(f) each OTP
Holder or OTP Firm relying on the Exemption would be required to
report, in accordance with Rule 6.6,\23\ (i) all equity option
positions (including those that are delta neutral) that are reportable
thereunder, and (ii) on its own behalf or on behalf of a designated
aggregation unit pursuant to proposed Rule 6.8 Commentary .09(d), for
each such account that holds an equity option position subject to the
Exemption in excess of the levels specified in Rule 6.8(a) Commentary
.05-06, the net delta and the options contract equivalent of the net
delta of such position.
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    \23\ NYSE Arca Rule 6.6 requires, among other things, that OTP
Holders and OTP Firms report to the Exchange aggregate long or short
positions on the same side of the market of 200 or more contracts of
any single class of options contracts dealt in on the Exchange.
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    The Exchange and other self-regulatory organizations are working on
modifying the Large Options Position Report system and/or OCC reports
to allow a member organization to indicate that an equity options
position is delta neutral.
    Records. Under proposed Rule 6.8 Commentary .09(g) each OTP Holder
or OTP Firm relying on the Exemption would be required to (i) retain,
and would be required to undertake reasonable efforts to ensure that
any affiliate of the OTP Holder or OTP Firm relying on the exemption
retains, a list of the options, securities and other instruments
underlying each options position net delta calculation reported to the
Exchange hereunder, and (ii) produce such information to the Exchange
upon request.\24\
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    \24\ An OTP Holder or OTP Firm would be authorized to report
position information of its affiliate pursuant to the written
statement required under proposed Rule 6.8 Commentary
.09(e)(3)(ii)(d).
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    Reliance on Federal Oversight. As provided under proposed Rule 6.8
Commentary .09(c) a permitted pricing model includes proprietary
pricing models used by OTP Holders and OTP Firms (and affiliates
thereof) that have been approved by the Commission, the FRB, or another
federal financial regulator. In adopting the proposed Exemption, the
Exchange would be

relying upon the rigorous approval processes and ongoing oversight of a
federal financial regulator. The Exchange notes that it would not be
under any obligation to verify whether an OTP Holder or OTP Firm or its
affiliate's use of a proprietary pricing model is appropriate or
yielding accurate results.
    This rule change will become effective upon filing, although it
will not become operative until such time that the Exchange, the OCC,
and the Securities Industry Automation Corporation (``SIAC'') have
completed required technology changes to automated reports used for
position limit surveillance. The operative date for the rule change
will be announced by NYSE Arca via an options regulatory bulletin,
within 30 days following the effective date of the filing. OTP Firms
and OTP Holders will not be able to take advantage of the delta
neutral-based equity hedge exemption contained in this proposal until
the announced operative date.
2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
Section 6(b) of the Act,\25\ in general, and furthers the objectives of
Section 6(b)(5) of the Act,\26\ in particular, in that it is designed
to promote just and equitable principles of trade, to prevent
fraudulent and manipulative acts and practices, to remove impediments
to and perfect the mechanism of a free and open market and a national
market system, and, in general, to protect investors and the public
interest. The Exchange believes the proposed delta neutral-based hedge
exemption from equity options position and exercise limits is
appropriate in that it is based on a widely accepted risk management
method used in options trading. Also, the Commission has previously
stated its support for recognizing options positions hedged on a delta
neutral basis as properly exempted from position limits.\27\
---------------------------------------------------------------------------

    \25\ 15 U.S.C. 78f(b).
    \26\ 15 U.S.C. 78f(b)(5).
    \27\ See Securities Exchange Act Release No. 40594 (October 23,
1998), 63 FR 59362, 59380 (November 3, 1998) (S7-30-97) (adopting
rules relating to OTC Derivatives Dealers).
---------------------------------------------------------------------------

B. Self-Regulatory Organization's Statement on Burden on Competition

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

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

    Written comments on the proposed rule change were neither solicited
nor received.

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

    Because the foregoing rule change does not: (1) Significantly
affect the protection of investors or the public interest; (2) impose
any significant burden on competition; and (3) become operative for 30
days after the date of this filing, or such shorter time as the
Commission may designate, it has become effective pursuant to Section
19(b)(3)(A) of the Act \28\ and Rule 19b-4(f)(6) thereunder.\29\
---------------------------------------------------------------------------

    \28\ 15 U.S.C. 78s(b)(3)(A).
    \29\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

    A proposed rule change filed under 19b-4(f)(6) normally may not
become operative prior to 30 days after the date of filing.\30\
However, Rule 19b-4(f)(6)(iii) \31\ permits the Commission to designate
a shorter time if such action is consistent with the protection of
investors and the public interest. The Exchange has requested that the
Commission waive the 30-day operative delay. The Commission believes
that waiving the 30-day operative delay is consistent with the
protection of investors and the public interest because such waiver
would allow the Exchange to implement the delta hedging exemption from
equity options position limits without needless delay. The Commission
notes that it recently approved a substantially similar proposal filed
by the Chicago Board Options Exchange, Incorporated.\32\ The Commission
believes that NYSE Arca's proposal to create a delta hedging exemption
from equity options position limits raises no new issues. For these
reasons, the Commission designates the proposed rule change to be
operative upon filing with the Commission.\33\
---------------------------------------------------------------------------

    \30\ 17 CFR 240.19b-4(f)(6)(iii). In addition, Rule 19b-
4(f)(6)(iii) requires that a self-regulatory organization submit to
the Commission written notice of its intent to file the proposed
rule change, along with a brief description and text of the proposed
rule change, at least five business days prior to the date of filing
of the proposed rule change, or such shorter time as designated by
the Commission. The Exchange has satisfied the five-day pre-filing
notice requirement.
    \31\ Id.
    \32\ See Securities Exchange Act Release No. 56970 (December 14,
2007), 72 FR 72428 (December 20, 2007) (SR-CBOE-2007-99).
    \33\ For the purposes only of waiving the 30-day operative
delay, the Commission has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of such proposed rule
change the Commission may summarily abrogate such rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors or otherwise in
furtherance of the purposes of the Act.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-NYSEArca-2008-17 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSEArca-2008-17. 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 the filing also will be available for
inspection and copying at the principal office of NYSE Arca. 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-NYSEArca-2008-17 and should
be submitted on or before March 21, 2008.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\34\
---------------------------------------------------------------------------

    \34\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Deputy Secretary.
[FR Doc. E8-3844 Filed 2-28-08; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register: December 29, 2008 (Volume 73, Number 249)]
[Proposed Rules]
[Page 79435-79436]
[DOCID:fr29de08-30]

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

40 CFR Part 52

[EPA-R06-OAR-2006-0389; FRL-8752-9]

Approval of Air Quality Implementation Plans; Oklahoma;
Recodification of Regulations

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: EPA is proposing to approve portions of revisions to the
Oklahoma State Implementation Plan (SIP) submitted on February 14,
2002. Most of the revisions are administrative in nature and modify
redundant or incorrect text within the SIP. The revisions also include
renumbered or recodified portions of the SIP and new sections that
incorporate Federal rules. We are approving the revisions in accordance
with the requirements of section 110 of the Clean Air Act (the Act) and
EPA's regulations.

DATES: Written comments must be received on or before January 28, 2009.

ADDRESSES: Comments may be mailed to Mr. Guy Donaldson, Chief, Air
Planning Section (6PD-L), Environmental Protection Agency, 1445 Ross
Avenue, Suite 1200, Dallas, Texas 75202-2733. Comments may also be
submitted electronically or through hand delivery/courier by following
the detailed instructions in the ADDRESSES section of the direct final
rule located in the rules section of this Federal Register.

FOR FURTHER INFORMATION CONTACT: Emad Shahin, Air Planning Section
(6PD-L), Environmental Protection Agency, Region 6, 1445 Ross Avenue,
Suite 700, Dallas, Texas 75202-2733, telephone<PHONE_NUMBER>; fax
number<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In the final rules section of this Federal
Register, EPA is approving the State's SIP submittal as a direct final
rule without prior proposal because the Agency views this as a
noncontroversial submittal and anticipates no adverse comments. A
detailed rationale for the approval is set forth in the direct final
rule. If no relevant adverse comments are received in response to this
action, no further activity is contemplated. If EPA receives adverse
comments, the direct final rule will be withdrawn and all public
comments received will be addressed in a subsequent final rule based on
this proposed rule. EPA will not institute a second comment period. Any
parties interested in commenting on this action should do so at this
time. Please note that if EPA receives adverse comment on an amendment,
paragraph, or section of this rule and if that provision may be severed
from the remainder of the rule, EPA may adopt as final those provisions
of the rule that are not the subject of an adverse comment.
    For additional information, see the direct final rule, which is
located in the rules section of this Federal Register.

    Dated: November 25, 2008.
Richard E. Greene,
Regional Administrator, Region 6.
 [FR Doc. E8-29978 Filed 12-24-08; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 76, Number 42 (Thursday, March 3, 2011)]
[Notices]
[Pages 11803-11805]
[FR Doc No: 2011-4654]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[USCG-2010-1137]

Collection of Information Under Review by Office of Management
and Budget: OMB Control Numbers: 1625-0058, 1625-0072 and 1625-0092

AGENCY: Coast Guard, DHS.

ACTION: Thirty-day notice requesting comments.

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

SUMMARY: In compliance with the Paperwork Reduction Act of 1995 the
U.S. Coast Guard is forwarding Information Collection Requests (ICRs),
abstracted below, to the, Office of Management and Budget (OMB), Office
of Information and Regulatory Affairs (OIRA), requesting approval of
revisions to the following collections of information: 1625-0058,
Application for Permit to Transport Municipal and Commercial Waste,
1625-0072, Waste Management Plans, Refuse Discharge Logs, Letters of
Instruction for Certain Persons-in-Charge (PIC) and Great Lakes Dry
Cargo Residue Recordkeeping, and 1625-0092 Sewage and Graywater
Discharge Records for Certain Cruise Vessels Operating on Alaskan
Waters. Our ICRs describe the information we seek to collect from the
public. Review and comments by OIRA ensure we only impose paperwork
burdens commensurate with our performance of duties.

DATES: Comments must reach the Coast Guard and OIRA on or before April
4, 2011.

ADDRESSES: You may submit comments identified by Coast Guard docket
number [USCG-2010-1137] to the Docket Management Facility (DMF) at the
U.S. Department of Transportation (DOT) and/or to OIRA. To avoid
duplicate submissions, please use only one of the following means:
    (1) Online: (a) To Coast Guard docket at http://www.regulation.gov.
(b) To OIRA by e-mail via<EMAIL_ADDRESS>    (2) Mail: (a) DMF (M-30), DOT, West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590-0001. (b) To
OIRA, 725 17th Street, NW., Washington, DC 20503, attention Desk
Officer for the Coast Guard.
    (3) Hand Delivery: To DMF address above, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The telephone number is
202-366-9329.
    (4) Fax: (a) To DMF,<PHONE_NUMBER>. (b) To OIRA at<PHONE_NUMBER>. To
ensure your comments are received in a timely manner, mark the fax,
attention Desk Officer for the Coast Guard.
    The DMF maintains the public docket for this Notice. Comments and
material received from the public, as well as documents mentioned in
this Notice as being available in the docket, will become part of the
docket and will be available for inspection or copying at room W12-140
on the West Building Ground Floor, 1200 New Jersey Avenue, SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. You may also find the docket on the Internet
at http://www.regulations.gov.
    Copies of the ICRs are available through the docket on the Internet
at http://www.regulations.gov. Additionally, copies are available from:
Commandant (CG-611), Attn: Paperwork Reduction Act Manager, U.S. Coast
Guard, 2100 2nd St., SW., STOP 7101, Washington DC 20593-7101.

FOR FURTHER INFORMATION CONTACT: Ms. Kenlinishia Tyler, Office of
Information Management, telephone<PHONE_NUMBER> or fax<PHONE_NUMBER>, for
questions on these documents. Contact Ms. Renee V. Wright, Program
Manager, Docket

Operations,<PHONE_NUMBER>, for questions on the docket.

SUPPLEMENTARY INFORMATION:

Public Participation and Request for Comments

    This Notice relies on the authority of the Paperwork Reduction Act
of 1995; 44 U.S.C. chapter 35, as amended. An ICR is an application to
OIRA seeking the approval, extension, or renewal of a Coast Guard
collection of information (Collection). The ICR contains information
describing the Collection's purpose, the Collection's likely burden on
the affected public, an explanation of the necessity of the Collection,
and other important information describing the Collections. There is
one ICR for each Collection.
    The Coast Guard invites comments on whether this ICR should be
granted based on the Collection being necessary for the proper
performance of Departmental functions. In particular, the Coast Guard
would appreciate comments addressing: (1) The practical utility of the
collections; (2) the accuracy of the estimated burden of the
collection; (3) ways to enhance the quality, utility, and clarity of
information subject to the collection; and (4) ways to minimize the
burden of collections on respondents, including the use of automated
collection techniques or other forms of information technology. These
comments will help OIRA determine whether to approve the ICR referred
to in this Notice.
    We encourage you to respond to this request by submitting comments
and related materials. Comments to Coast Guard or OIRA must contain the
OMB Control Number of the ICR. They must also contain the docket number
of this request, [USCG 2010-1137], and must be received by April 4,
2011. We will post all comments received, without change, to http://www.regulations.gov. They will include any personal information you
provide. We have an agreement with DOT to use their DMF. Please see the
``Privacy Act'' paragraph below.

Submitting Comments

    If you submit a comment, please include the docket number [USCG-
2010-1137], indicate the specific section of the document to which each
comment applies, providing a reason for each comment. You may submit
your comments and material online (via http://www.regulations.gov), by
fax, mail, or hand delivery, but please use only one of these means. If
you submit a comment online via http://www.regulations.gov, it will be
considered received by the Coast Guard when you successfully transmit
the comment. If you fax, hand deliver, or mail your comment, it will be
considered as having been received by the Coast Guard when it is
received at the DMF. We recommend you include your name, mailing
address, an e-mail address, or other contact information in the body of
your document so that we can contact you if we have questions regarding
your submission.
    You may submit comments and material by electronic means, mail,
fax, or delivery to the DMF at the address under ADDRESSES, but please
submit them by only one means. To submit your comment online, go to
http://www.regulations.gov, and type ``USCG-2010-1137'' in the
``Keyword'' box. If you submit your comments by mail or hand delivery,
submit them in an unbound format, no larger than 8[frac12] by 11
inches, suitable for copying and electronic filing. If you submit
comments by mail and would like to know that they reached the Facility,
please enclose a stamped, self-addressed postcard or envelope. We will
consider all comments and material received during the comment period
and will address them accordingly.

Viewing Comments and Documents

    To view comments, as well as documents mentioned in this Notice as
being available in the docket, go to http://www.regulations.gov, click
on the ``read comments'' box, which will then become highlighted in
blue. In the ``Keyword'' box insert ``USCG-2010-1137'' and click
``Search.'' Click the ``Open Docket Folder'' in the ``Actions'' column.
You may also visit the DMF in Room W12-140 on the ground floor of the
DOT West Building, 1200 New Jersey Avenue, SE., Washington, DC 20590,
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays.
    OIRA posts its decisions on ICRs online at http://www.reginfo.gov/public/do/PRAMain after the comment period for each ICR. An OMB Notice
of Action on each ICR will become available via a hyperlink in the OMB
Control Number: USCG-2010-0978.

Privacy Act

    Anyone can search the electronic form of comments received in
dockets by the name of the individual submitting the comment (or
signing the comment, if submitted on behalf of an association,
business, labor union, etc.). You may review a Privacy Act statement
regarding Coast Guard public dockets in the January 17, 2008, issue of
the Federal Register (73 FR 3316).

Previous Request for Comments

    This request provides a 30-day comment period required by OIRA. The
Coast Guard has published the 60-day notice (75 FR 82038, December 29,
2010) required by 44 U.S.C. 3506(c)(2). That Notice elicited no
comments.

Information Collection Requests

    1. Title: Application for Permit to Transport Municipal and
Commercial Waste.
    OMB Control Number: 1625-0058.
    Type of Request: Revision of a previously approved collection.
    Respondents: Owners and operators of vessels.
    Abstract: This information collection provides the basis for
issuing or denying a permit, required under 33 U.S.C. 2601 and 33 CFR
151.1009, for the transportation of municipal or commercial waste in
the coastal waters of the United States.
    Forms: None.
    Burden Estimate: The estimated burden has decreased from 116 hours
to 13 hours a year.
    2. Title: Waste Management Plans, Refuse Discharge Logs, Letters of
Instruction for Certain Persons-in-Charge (PIC) and Great Lakes Dry
Cargo Residue Recordkeeping.
    OMB Control Number: 1625-0072.
    Type of Request: Revision of a previously approved collection.
    Respondents: Owners, operators, masters, and persons-in-charge of
vessels.
    Abstract: This information is needed to ensure that: (1) Certain
U.S. oceangoing vessels develop and maintain a waste management plan;
(2) certain U.S. oceangoing vessels maintain refuse discharge records;
(3) certain individuals that act as person-in-charge of the transfer of
fuel receive a letter of instruction, for prevention of pollution; and
(4) certain Great Lakes vessels comply with dry cargo residue
requirements.
    Forms: CG-33.
    Burden Estimate: The estimated burden has decreased from 67,030
hours to 65,464 hours a year.
    3. Title: Sewage and Graywater Discharge Records for Certain Cruise
Vessels Operating on Alaskan Waters.
    OMB Control Number: 1625-0092.
    Type of Request: Revision of a previously approved collection.
    Respondents: Owners, operators and masters of vessels.
    Abstract: To comply with the Consolidated Appropriations Act, 2001,
Public Law 106-554, 114 Stat. 2763, 2763A-315, this information
collection is needed to enforce sewage and

graywater discharges requirements from certain cruise ships operating
on Alaskan waters.
    Forms: Not applicable.
    Burden Estimate: The estimated burden has increased from 637 hours
to 2,121 hours a year.

    Authority: The Paperwork Reduction Act of 1995; 44 U.S.C.
chapter 35, as amended.

    Dated: February 24, 2011.
R. E. Day,
Rear Admiral, U.S. Coast Guard, Assistant Commandant for Command,
Control, Communications, Computers and Information Technology.
[FR Doc. 2011-4654 Filed 3-2-11; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 77, Number 123 (Tuesday, June 26, 2012)]
[Rules and Regulations]
[Page 38005]
[FR Doc No: 2012-15545]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG 2012-0417]

Safety Zone; Independence Day Fireworks, Kings Beach, CA

AGENCY: Coast Guard, DHS.

ACTION: Notice of enforcement of regulation.

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

SUMMARY: The Coast Guard will enforce the safety zone for the Kings
Beach Independence Day Fireworks display from 7 a.m. until 10 p.m. on
July 3, 2012. This action is necessary to protect life and property of
the maritime public from the hazards associated with the fireworks
display. During the enforcement period, unauthorized persons or vessels
are prohibited from entering into, transiting through, or anchoring in
the safety zone, unless authorized by the Patrol Commander (PATCOM).

DATES: The regulations in 33 CFR 165.1191, Table 1, number 20, will be
enforced from 7 a.m. through 10 p.m. on July 3, 2012.

FOR FURTHER INFORMATION CONTACT: If you have questions on this notice,
call or email Ensign William Hawn, Sector San Francisco Waterways
Safety Division, U.S. Coast Guard; telephone<PHONE_NUMBER>, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Coast Guard will enforce a safety zone
in navigable waters around and under the fireworks barge within a
radius of 100 feet during the loading, transit, and arrival of the
fireworks barge to the display location and until the start of the
fireworks display. From 7 a.m. until 9 a.m. on July 3, 2012, the
fireworks barge will be loaded off of Tahoe Keys Marina in South Lake
Tahoe, CA at position 38[deg]56'05'' N, 120[deg]00'09'' W (NAD 83).
From 9 a.m. to 11 a.m. on July 3, 2012, the loaded barge will transit
from Tahoe Keys Marina to the launch site off of Kings Beach, CA at
position 39[deg]13'55'' N, 120[deg]01'42'' W (NAD 83) where it will
remain until the commencement of the fireworks display. Upon the
commencement of the 20 minute fireworks display, scheduled to take
place from 9:30 p.m. to 9:50 p.m. on July 3, 2012, the safety zone will
increase in size to encompass the navigable waters around and under the
fireworks barge within a radius 1,000 feet at position 39[deg]13'55''
N, 120[deg]01'42'' W (NAD 83) for the Kings Beach Independence Day
Fireworks display in 33 CFR 165.1191. This safety zone will be in
effect from 7 a.m. until 10 p.m. on July 3, 2012.
    Under the provisions of 33 CFR 165.1191, unauthorized persons or
vessels are prohibited from entering into, transiting through, or
anchoring in the safety zone during all applicable effective dates and
times, unless authorized to do so by the PATCOM. Additionally, each
person who receives notice of a lawful order or direction issued by an
official patrol vessel shall obey the order or direction. The PATCOM is
empowered to forbid entry into and control the regulated area. The
PATCOM shall be designated by the Commander, Coast Guard Sector San
Francisco. The PATCOM may, upon request, allow the transit of
commercial vessels through regulated areas when it is safe to do so.
    This notice is issued under authority of 33 CFR 165.1191 and 5
U.S.C. 552(a). In addition to this notice in the Federal Register, the
Coast Guard will provide the maritime community with extensive advance
notification of the safety zone and its enforcement period via the
Local Notice to Mariners.
    If the Captain of the Port determines that the regulated area need
not be enforced for the full duration stated in this notice, a
Broadcast Notice to Mariners may be used to grant general permission to
enter the regulated area.

    Dated: June 6, 2012.
Cynthia L. Stowe,
Captain, U.S. Coast Guard, Captain of the Port San Francisco.
[FR Doc. 2012-15545 Filed 6-25-12; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 86, Number 33 (Monday, February 22, 2021)]
[Proposed Rules]
[Page 10504]
[FR Doc No: 2021-01771]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[FAA Rules Docket No. 90-CE-35-AD]
RIN 2120-AA64

Airworthiness Directives; Textron Aviation Inc. (Type Certificate
previously held by Cessna Aircraft Company) Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Proposed rule; withdrawal.

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

SUMMARY: The FAA is withdrawing a notice of proposed rulemaking (NPRM)
and supplemental notice of proposed rulemaking (SNPRM) that proposed to
supersede airworthiness directive (AD) 72-14-08 R1 for Cessna Aircraft
Company (now Textron Aviation Inc.) Models 310, 320, 401, 402, 411, and
421 airplanes. AD 72-14-08 R1 requires repetitively inspecting the fuel
and oil flexible hose lines for leakage or evidence of any damaged or
deteriorated hose assembly on the above-referenced airplanes and
replacing any discrepant part. Since issuance of the SNPRM, the FAA has
not received any reports of fuel and oil flexible hose lines that leak
or are damaged and has determined that the repetitive inspections
required by AD 72-14-08 R1 address the unsafe condition. Accordingly,
the NPRM and SNPRM are withdrawn.

DATES: As of February 22, 2021, the proposed rules, which published in
the Federal Register on October 23, 1990 (55 FR 42726), and October 22,
1998 (63 FR 56579), are withdrawn.

FOR FURTHER INFORMATION CONTACT: Jeff Janusz, Supervisory Aviation
Safety Specialist, Wichita ACO Branch, FAA, 1801 Airport Road, Wichita,
Kansas 67209; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>or b5e2dcd6dddcc1d498f6fae6f5d3d4d49bd2dac3.

SUPPLEMENTARY INFORMATION:

Discussion

    The FAA issued an NPRM that proposed to amend part 39 of the
Federal Aviation Regulations (14 CFR part 39) to supersede AD 72-14-
08R1, Amendment 39-4215 (46 FR 45597, September 14, 1981) (AD 72-14-08
R1), which applies to Cessna Aircraft Company Models 310, 320, 401,
402, 411, and 421 series airplanes. The current type certificate holder
for these airplanes is Textron Aviation Inc. The NPRM published in the
Federal Register on October 23, 1990 (55 FR 42726). The FAA
subsequently issued an SNPRM, which published on October 22, 1998 (63
FR 56579). The NPRM and SNPRM proposed to:
     Initially retain the requirement of repetitively
inspecting the fuel and oil flexible hose lines for leakage or evidence
of any damaged or deteriorated hose assembly on all of the affected
airplanes, and replacing any discrepant part; and
     eventually require, regardless if damage or deterioration
was found, replacing the fuel and oil flexible hose assemblies in the
engine compartment with an improved design hose assembly as terminating
action for the repetitive inspection requirement. For some models, the
replacement would have been mandatory and for others it would have been
an option instead of continuing the repetitive inspections.

Actions Since the SNPRM Was Issued

    Since issuance of the SNPRM, FAA has not received any reports of
fuel and oil flexible hose lines that leak or are damaged and has
determined that the repetitive inspections required by AD 72-14-08 R1
address the unsafe condition. Therefore, the FAA determined that
further AD action is not warranted and the proposals should be
withdrawn.
    Withdrawal of the NPRM and SNPRM constitutes only such action and
does not preclude the agency from issuing future rulemaking on this
issue, nor does it commit the agency to any course of action in the
future.

Regulatory Findings

    Since this action only withdraws an NPRM and SNPRM, it is neither a
proposed nor a final rule and therefore, not covered under Executive
Order 12866 or the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

The Withdrawal

0
Accordingly, the notice of proposed rulemaking, which published in the
Federal Register on October 23, 1990 (55 FR 42726), and the
supplemental notice of proposed rulemaking, which published in the
Federal Register on October 22, 1998 (63 FR 56579), are withdrawn.

    Issued on January 20, 2021.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2021-01771 Filed 2-19-21; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 82, Number 155 (Monday, August 14, 2017)]
[Notices]
[Pages 37866-37869]
[FR Doc No: 2017-17119]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-4515]

International Drug Scheduling; Convention on Psychotropic
Substances; Single Convention on Narcotic Drugs; Ocfentanil,
Carfentanil, Pregabalin, Tramadol, Cannabidiol, Ketamine, and Eleven
Other Substances; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is requesting
interested persons to submit comments concerning abuse potential,
actual abuse, medical usefulness, trafficking, and impact of scheduling
changes on availability for medical use of 17 drug substances. These
comments will be considered in preparing a response from the United
States to the World Health Organization (WHO) regarding the abuse
liability and diversion of these drugs. WHO will use this information
to consider whether to recommend that certain international
restrictions be placed on these drugs. This notice requesting comments
is required by the Controlled Substances Act (the CSA).

DATES: Submit either electronic or written comments by September 13,
2017.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before September 13, 2017. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of September 13, 2017. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for Written/Paper
Submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2017-N-4515 for ``International Drug Scheduling; Convention on
Psychotropic Substances; Single Convention on Narcotic Drugs;
Ocfentanil; Furanyl fentanyl (Fu-F); Acryloylfentanyl (Acrylfentanyl);
Carfentanil; 4-fluoroisobutyrfentanyl (4-FIBF);
Tetrahydrofuranylfentanyl (THF-F); 4-fluoroamphetamine (4-FA); AB-
PINACA; AB-CHMINACA; 5F-PB-22; UR-144; 5F-ADB; Etizolam; Pregabalin;
Tramadol; Cannabidiol; Ketamine; Request for Comments.'' Received
comments, those filed in a timely manner (see ADDRESSES), will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential

with a heading or cover note that states ``THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including
the claimed confidential information, in its consideration of comments.
The second copy, which will have the claimed confidential information
redacted/blacked out, will be available for public viewing and posted
on https://www.regulations.gov. Submit both copies to the Dockets
Management Staff. If you do not wish your name and contact information
to be made publicly available, you can provide this information on the
cover sheet and not in the body of your comments and you must identify
this information as ``confidential.'' Any information marked as
``confidential'' will not be disclosed except in accordance with 21 CFR
10.20 and other applicable disclosure law. For more information about
FDA's posting of comments to public dockets, see 80 FR 56469, September
18, 2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: James R. Hunter, Center for Drug
Evaluation and Research, Controlled Substance Staff, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 5150, Silver
Spring, MD 20993-0002,<PHONE_NUMBER>, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    The United States is a party to the 1971 Convention on Psychotropic
Substances (Psychotropic Convention). Article 2 of the Psychotropic
Convention provides that if a party to the convention or WHO has
information about a substance, which in its opinion may require
international control or change in such control, it shall so notify the
Secretary-General of the United Nations (the U.N. Secretary-General)
and provide the U.N. Secretary-General with information in support of
its opinion.
    Section 201 of the CSA (21 U.S.C. 811) (Title II of the
Comprehensive Drug Abuse Prevention and Control Act of 1970) provides
that when WHO notifies the United States under Article 2 of the
Psychotropic Convention that it has information that may justify adding
a drug or other substances to one of the schedules of the Psychotropic
Convention, transferring a drug or substance from one schedule to
another, or deleting it from the schedules, the Secretary of State must
transmit the notice to the Secretary of Health and Human Services
(Secretary of HHS). The Secretary of HHS must then publish the notice
in the Federal Register and provide opportunity for interested persons
to submit comments that will be considered by HHS in its preparation of
the scientific and medical evaluations of the drug or substance.

II. WHO Notification

    The Secretary of HHS received the following notice from WHO (non-
relevant text removed):

Ref.: C.L.xx.2017

    The World Health Organization (WHO) presents its compliments to
Member States and Associate Members and has the pleasure of
informing that the Thirty-ninth Expert Committee on Drug Dependence
(ECDD) will meet in Geneva from 6 to 10 November 2017 to review a
number of substances with potential for dependence, abuse and harm
to health, and will make recommendations to the U.N. Secretary-
General, on the need for and level of international control of these
substances.
    At its 126th session in January 2010, the Executive Board
approved the publication ``Guidance on the WHO review of
psychoactive substances for international control'' (EB126/2010/
REC1, Annex 6) which requires the Secretariat to request relevant
information from Ministers of Health in Member States to prepare a
report for submission to the ECDD. For this purpose, a questionnaire
was designed to gather information on the legitimate use, harmful
use, status of national control and potential impact of
international control for each substance under evaluation. Member
States are invited to collaborate, as in the past, in this process
by providing pertinent information as requested in the questionnaire
and concerning substances under review.
    It would be appreciated if a person from the Ministry of Health
could be designated as the focal point responsible for coordinating
and answering the questionnaire. (non relevant information from
letter not shown, see letter for text not shown here) The designated
focal point, and only this person, should access and complete the
questionnaires:

1. Ocfentanil
2. Furanyl fentanyl (Fu-F)
3. Acryloylfentanyl (Acrylfentanyl)
4. Carfentanil
5. 4-fluoroisobutyrfentanyl (4-FIBF)
6. Tetrahydrofuranylfentanyl (THF-F)
7. 4-fluoroamphetamine (4-FA)
8. AB-PINACA
9. AB-CHMINACA
10. 5F-PB-22
11. UR-144
12. 5F-ADB
13. Etizolam
14. Pregabalin
15. Tramadol
16. Cannabidiol
17. Ketamine

    PDF versions of the questionnaire in English, French and Spanish
may be downloaded from the link http://www.who.int/medicines/access/controlled-substances/ecdd/en/. Please note that these versions are
for reference only and all questionnaires must be answered through
the online system. Further clarification regarding the questionnaire
may be obtained from the Secretariat by emailing:
<EMAIL_ADDRESS>    Replies to the questionnaire must reach the Secretariat by 30
September 2017 in order to facilitate analyses and preparation of
the report before the planned meeting. Where there is a competent
National Authority under the International Drug Control Treaties, it
is kindly requested that the questionnaire be completed in
collaboration with such body.
    The summary information from the questionnaire will be published
online as part of the report on the Web site for the Thirty-ninth
ECDD linked to the Department of Essential Medicines and Health
Products (EMP). The provisional agenda of the Thirty-ninth ECDD and
the list of psychoactive substances under review are also published
on Thirty-ninth ECDD Web page: http://www.who.int/medicines/access/controlled-substances/ecdd/en/.
    Member States are also encouraged to provide any additional
relevant information (unpublished or published) that is available on
these substances to<EMAIL_ADDRESS>This information will
be an invaluable contribution to the ECDD and all submissions will
be treated as confidential.
    The World Health Organization takes this opportunity to renew to
Member States and Associate Members the assurance of its highest
consideration.

GENEVA, 7 July 2017

    FDA has verified the Web site addresses contained in the WHO
notice, as of the date this document publishes in the Federal Register,
but Web sites are subject to change over time.

III. Substances Under WHO Review

    Ocfentanil is a synthetically produced opioid that is structurally
related to fentanyl and approximately equipotent in effect. Reported
risks associated with use of ocfentanil include development of opioid
use disorder, overdose, and fatal overdose. It has no approved medical
use in the United States and is not a controlled substance in the
United States under the CSA.
    Furanyl fentanyl (Fu-F) is a potent clandestinely produced
synthetic opioid that is an analog of fentanyl. Evidence suggests that
the pattern of abuse of fentanyl analogues, including furanyl fentanyl,
parallels that of heroin and

prescription opioid analgesics. Fu-F produces the typical opioid
effects that include respiratory depression and loss of consciousness.
Seizures of Fu-F have been encountered in powder form. Fu-F has been
connected to fatal overdoses, in which intravenous routes of
administration are documented. It has no approved medical use in the
United States. On November 29, 2016, the Drug Enforcement
Administration (DEA) issued a final order to temporarily schedule Fu-F
and its isomers, esters, ethers, salts and salts of isomers, esters and
ethers, into Schedule I pursuant to the temporary scheduling provisions
of the CSA.
    Acryloylfentanyl (Acrylfentanyl) belongs to the 4-anilidopiperidine
class of synthetic opioids and is similar in structure to fentanyl.
Acryloylfentanyl is a clandestinely produced analog of fentanyl and
sold illegally as a research chemical on several Web sites.
Acryloylfentanyl has also been associated with adverse events typically
associated with opioid use such as respiratory depression, anxiety,
constipation, tiredness, hallucinations, and withdrawal. The use of
acryloylfentanyl has also been linked to the development of opioid use
disorder, overdose, and fatal overdose. Acryloylfentanyl has no
commercial or medical uses. On July 14, 2017, the DEA issued a
temporary order to temporarily schedule acryloylfentanyl, its isomers,
esters, ethers, salts and salts of isomers, esters, and ethers, into
Schedule I pursuant to the temporary scheduling provisions of the CSA.
    Carfentanil, also known as 4-carbomethoxyfentanyl, is an extremely
potent synthetic opioid that is similar in structure to and
approximately 100 times more potent than fentanyl as an analgesic. At
one time legitimately produced, carfentanil is no longer manufactured,
marketed, or used in the United States; it is approved by FDA for use
under restricted conditions by veterinarians as a immobilizing agent
for certain large animals. Illicitly produced carfentanil is a
particularly harmful fentanyl analogue that is also being laced into
heroin or sold by itself and trafficked in the United States. It is not
approved for human use. Drug seizure data indicate that carfentanil is
typically used in small doses to cut heroin and other illicitly abused
drugs. The significant risk to public health associated with
carfentanil use stems from its respiratory depressive effects with very
small amounts. Several fatalities have been reported as the result of
carfentanil overdoses. On October 28, 1988, the DEA placed carfentanil
in Schedule II of the CSA.
    4-fluoroisobutyrfentanyl is a clandestinely produced synthetic
opioid that is an analog of fentanyl. It has [micro]-receptor agonist
activity similar to that of fentanyl. This would result in effects
associated with opioid agonists such as analgesia, respiratory
depression, anxiety, constipation, tiredness, hallucinations,
withdrawal, the development of opioid use disorder, overdose, and fatal
overdose. The use of 4-fluoroisobutyrfentanyl has been implicated in
several cases of overdose and fatal overdoses. 4-fluoroisobutyrfentanyl
has not been approved for medical use in the U.S. On May 3, 2017, the
DEA issued a temporary order to temporarily schedule 4-
fluoroisobutyrfentanyl, its isomers, esters, ethers, salts and salts of
isomers, esters and ethers, into Schedule I pursuant to the temporary
scheduling provisions of the CSA.
    Tetrahydrofuranylfentanyl (THF-F) is a synthetic opioid that is an
analog of fentanyl. It has [micro]-receptor agonist activity similar to
that of fentanyl, resulting in effects associated with opioid agonists
such as analgesia, respiratory depression, anxiety, constipation,
tiredness, hallucinations, withdrawal, the development of opioid use
disorder, overdose, and fatal overdose. THF-F is not approved for
medical use or controlled in the United States under the CSA.
    4-Fluoroamphetamine (4-FA) is a psychoactive substance of the
phenethylamine and substituted amphetamine chemical classes and
produces stimulant effects. WHO reports that 4-FA is clandestinely
produced, and its use is associated with fatal and non-fatal
intoxications. 4-FA was reviewed at the 37th ECDD (2015) and, while not
placed under international control due to insufficient data, was kept
under surveillance. 4-FA is not approved for medical use in the United
States and it is not controlled under the CSA.
    AB-PINACA is a clandestinely produced synthetic cannabinoid agonist
approximately 1.5 times as potent as delta-9-tetrahydrocannabinol.
Adverse effects produced by cannabinoid agonists include tachycardia,
agitation, hallucination, chest pain, seizure, anxiety, acute
psychosis, and death. AB-PINACA has been detected in illicit synthetic
cannabinoid substances, and reported in cases of overdose and
hospitalizations. It has not been approved for medical use in the
United States. On January 27, 2017, the DEA published a Notice of
Proposed Rulemaking to permanently control AB-PINACA as a Schedule I
substance under the CSA.
    AB-CHMINACA is a clandestinely produced synthetic cannabinoid
agonist that is approximately 16 times more potent than delta-9-
tetrahydrocannabinol. Adverse effects produced by cannabinoid agonists
include tachycardia, agitation, hallucination, chest pain, seizure,
anxiety, acute psychosis, and death. AB-CHMINACA has been detected in
illicit synthetic cannabinoid substances and found in cases of overdose
and hospitalizations. AB-CHMINACA has not been pre-reviewed or
critically reviewed by the WHO. On January 27, 2017, the DEA published
a Notice of Proposed Rulemaking to permanently control AB-CHMINACA as a
Schedule I substance under the CSA.
    5F-PB-22 is a synthetic cannabinoid agonist with similar effects to
delta-9-tetrahydrocannabinol, one of the main psychoactive components
of cannabis. Adverse effects produced by cannabinoid agonists include
tachycardia, agitation, hallucination, chest pain, seizure, anxiety,
acute psychosis, and death. 5F-PB-22 is clandestinely produced. It has
been found laced on plant material and marketed as herbal products, and
is smoked for its psychoactive effects. According to the WHO, 5F-PB-22
has been associated with fatal intoxications. On September 6, 2016, the
DEA issued a final rule to permanently place 5F-PB-22 into Schedule I
of the CSA.
    UR-144 is a clandestinely produced synthetic cannabinoid agonist.
In general, adverse effects produced by cannabinoid agonists include
tachycardia, agitation, hallucination, chest pain, seizure, anxiety,
and acute psychosis. UR-144 has been detected in herbal smoking blends
that are sold as herbal incense. In June 2014, the 36th (2014) ECDD
reviewed UR-144 and recommended that it be placed under surveillance.
On May 11, 2016, the DEA issued a final rule to permanently schedule
UR-144 into Schedule I of the CSA.
    5F-ADB is a clandestinely produced synthetic cannabinoid agonist.
In general, adverse effects produced by cannabinoid agonists include
tachycardia, agitation, hallucination, chest pain, seizure, anxiety,
and acute psychosis. 5F-ADB has been identified in overdose and/or
cases involving death attributed to their abuse. Adverse health effects
reported from incidents involving 5F-ADB and other synthetic
cannabinoids have included: Nausea, persistent vomiting, agitation,
altered mental status, seizures, convulsions, loss of consciousness,
and/or cardio toxicity. On April 10, 2017, the DEA issued a temporary
scheduling order to

temporarily schedule 5F-ADB, its isomers, esters, ethers, salts and
salts of isomers, esters, and ethers into Schedule I pursuant to the
temporary scheduling provisions of the CSA.
    Etizolam belongs to a class of substances known as benzodiazepines.
Benzodiazepines produce central nervous system depression and are
commonly used to treat insomnia, anxiety, and seizure disorders.
Etizolam is currently prescribed in some countries to treat generalized
anxiety disorder with depressive symptoms, but is not approved for
medical use or controlled in the United States under the CSA. WHO
reported that non-fatal intoxications that include cases of driving
under the influence of drugs have been linked to etizolam. The ECDD at
its 37th (2015 meeting reviewed etizolam and recommended that a
critical review of etizolam is warranted.
    Pregabalin is an anticonvulsant-type drug used to treat pain
generated from the nervous system. It is available as an oral capsule
and oral solution and approved for medical use in the United States for
the management of neuropathic pain associated with diabetic peripheral
neuropathy, post-herpetic neuralgia, and adjunctive therapy for partial
onset seizures, fibromyalgia, and neuropathic pain associated with
spinal cord injury. Although the mechanism of action of pregabalin is
unknown, studies in animals suggest that binding to the nervous system
tissues may be involved in its pain-relieving and anti-seizure effects.
Pregabalin binds with high affinity to the alpha 2-delta receptor site
(a subunit of voltage-gated calcium channels) in the central nervous
system. The binding of pregabalin at this site is thought to be
responsible for its therapeutic effect on neuropathic pain. Reports
indicate that patients are self-administering higher than recommended
doses to achieve euphoria, especially patients who have a history of
substance abuse, particularly opioids, and psychiatric illness. While
effects of excessively high doses are generally non-lethal,
gabapentinoids such as pregabalin are increasingly being identified in
post-mortem toxicology analyses. Pregabalin is a Schedule V controlled
substance in the United States under the CSA.
    Tramadol is an opioid analgesic that produces its primary opioid-
like action through an active metabolite referred to as the M1
metabolite (O-desmethyltramadol). Tramadol was first approved for
marketing in the United States in 1995 and is available as immediate-
release, extended-release, and combination products for the treatment
of moderate to moderately severe pain. On July 2, 2014, the DEA
published a final rule in the Federal Register controlling tramadol as
a Schedule IV substance of the CSA effective from August 18, 2014.
Tramadol was pre-reviewed by the ECDD at its 28th (1992) and 32nd
(2000) meetings, and critically reviewed at the 33rd (2002) meeting and
not recommended for international control but placed on surveillance.
Tramadol was pre-reviewed again by the ECDD at its 34th (2006) meeting;
however, the ECDD concluded that there was not sufficient evidence to
justify a critical review. At the 36th (2014) meeting, the ECDD
considered updated information on tramadol, but again concluded that
there was insufficient evidence to warrant a critical review.
    Cannabidiol (CBD) is one of the active cannabinoids identified in
cannabis. CBD has been shown to be beneficial in experimental models of
several neurological disorders, including those of seizure and
epilepsy. In the United States, CBD-containing products are in human
clinical testing in three therapeutic areas, but no such products are
approved by FDA for marketing for medical purposes in the United
States. CBD is a Schedule I controlled substance under the CSA. At the
37th (2015) meeting of the ECDD, the committee requested that the
Secretariat prepare relevant documentation to conduct pre-reviews for
several substances, including CBD.
    Ketamine is classified as a rapid-acting general anesthetic agent
used for short diagnostic and surgical procedures that do not require
skeletal muscle relaxation. It is marketed in the United States as a
solution for injection. Ketamine is controlled in Schedule III of the
CSA in the United States. It is not controlled internationally under
the Convention on Psychotropic Substances or the Single Convention on
Narcotic Drugs. The ECDD reviewed ketamine at its 34th (2006), 35th
(2012), and 36th (2014) meetings. On March 13, 2015, the Commission on
Narcotic Drugs (CND) decided by consensus to postpone the consideration
of a proposal concerning the recommendation to place ketamine in
Schedule IV of the Psychotropic Convention. The CND requested
additional information from the WHO. The ECDD reviewed updated
information at its 37th (2015) meeting and found no reason to recommend
a new pre-review or critical review of ketamine that could potentially
change its standing 2014 recommendation that ketamine should not be
placed under international control.

IV. Opportunity To Submit Domestic Information

    As required by section 201(d)(2)(A) of the CSA, FDA, on behalf of
HHS, invites interested persons to submit comments regarding the 17
named drug substances. Any comments received will be considered by HHS
when it prepares a scientific and medical evaluation of these drug
substances. HHS will forward a scientific and medical evaluation of
these drug substances to WHO, through the Secretary of State, for WHO's
consideration in deciding whether to recommend international control/
decontrol of any of these drug substances. Such control could limit,
among other things, the manufacture and distribution (import/export) of
these drug substances and could impose certain recordkeeping
requirements on them.
    Although FDA is, through this notice, requesting comments from
interested persons, which will be considered by HHS when it prepares an
evaluation of these drug substances, HHS will not now make any
recommendations to WHO regarding whether any of these drugs should be
subjected to international controls. Instead, HHS will defer such
consideration until WHO has made official recommendations to the
Commission on Narcotic Drugs, which are expected to be made in early
2018. Any HHS position regarding international control of these drug
substances will be preceded by another Federal Register notice
soliciting public comments, as required by section 201(d)(2)(B) of the
CSA.

V. Electronic Access

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

    Dated: August 9, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-17119 Filed 8-11-17; 8:45 am]
 BILLING CODE 4164-01-P