[Federal Register: February 26, 2009 (Volume 74, Number 37)]
[Proposed Rules]
[Page 8761-8763]
[DOCID:fr26fe09-27]

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Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2008-1220]
RIN 1625-AA00

Safety Zone; Blue Water Resort and Casino APBA National Tour
Rounds 1 & 2; Colorado River, Parker, AZ

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Coast Guard proposes establishing a temporary safety zone
within the Lake Moolvalya region of the navigable waters of the
Colorado River in Parker, Arizona for the Blue Water Resort and Casino
APBA National Tour Rounds 1 and 2. This temporary safety zone is
necessary to provide for the safety of the participants, crew,
spectators, participating vessels, and other vessels and users of the
waterway. Persons and vessels are prohibited from entering into,
transiting through, or anchoring within this safety zone unless
authorized by the Captain of the Port, or his designated
representative.

DATES: Comments and related material must either be submitted to our
online docket via http://www.regulations.gov on or before March 30,
2009 or reach the Docket Management Facility by that date.

ADDRESSES: You may submit comments identified by docket number USCG-
2008-1220 using any one of the following methods:
    (1) Federal eRulemaking Portal: http://www.regulations.gov.
    (2) Fax:<PHONE_NUMBER>.
    (3) Mail: Docket Management Facility (M-30), U.S. Department of
Transportation, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590-0001.
    (4) Hand delivery: Same as mail address above, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. The telephone
number is<PHONE_NUMBER>.
    To avoid duplication, please use only one of these methods. For
instructions on submitting comments, see the ``Public Participation and
Request for Comments'' portion of the SUPPLEMENTARY INFORMATION section
below.

FOR FURTHER INFORMATION CONTACT: If you have questions on this proposed
rule, call Petty Officer Kristen Beer, USCG, Waterways Management, U.S.
Coast Guard Sector San Diego at<PHONE_NUMBER>. If you have questions
on viewing or submitting material to the docket, call Renee V. Wright,
Program Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Public Participation and Request for Comments

    We encourage you to participate in this rulemaking by submitting
comments and related materials. All comments received will be posted,
without change, to http://www.regulations.gov and will include any
personal information you have provided.

Submitting Comments

    If you submit a comment, please include the docket number for this
rulemaking (USCG-2008-1220), indicate the specific section of this
document to which each comment applies, and provide a reason for each
suggestion or recommendation. You may submit your comments and material
online, or by fax, mail or hand delivery, but please use only one of
these means. We recommend that you include your name and a mailing
address, an e-mail address, or a phone number in the body of your
document so that we can contact you if we have questions regarding your
submission.
    To submit your comment online, go to http://www.regulations.gov,
select the Advanced Docket Search option on the right side of the
screen, insert ``USCG-2008-1220'' in the Docket ID box, press Enter,
and then click on the balloon shape in the Actions column. If you
submit your comments by mail or hand delivery, submit them in an
unbound format, no larger than 8\1/2\ by 11 inches, suitable for
copying and electronic filing. If you submit them 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 may change the rule
based on your comments.

Viewing Comments and Documents

    To view comments, as well as documents mentioned in this preamble
as being available in the docket, go to http://www.regulations.gov,
select the Advanced Docket Search option on the right side of the
screen, insert USCG-2008-1220 in the Docket ID box, press Enter, and
then click on the item in the Docket ID column. You may also visit
either the Docket Management Facility in Room W12-140 on the ground
floor of the Department of Transportation West Building, 1200 New
Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays; or the U.S. Coast Guard
Sector San Diego, 2710 N. Harbor Drive, San Diego, CA 92101 between 8
a.m. and 3 p.m., Monday through Friday, except Federal holidays. We
have an agreement with the Department of Transportation to use the
Docket Management Facility.

Privacy Act

    Anyone can search the electronic form of comments received into any
of our 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 notice
regarding our public dockets in the January 17, 2008 issue of the
Federal Register (73 FR 3316).

Public Meeting

    We do not now plan to hold a public meeting. But you may submit a
request for one to the Docket Management Facility at the address under
ADDRESSES explaining why one would be beneficial. If we determine that
one would aid this rulemaking, we will hold one at a time and place
announced by a later notice in the Federal Register.

Background and Purpose

    The RPM Racing Enterprises is sponsoring the Blue Water Resort and
Casino APBA National Tour Rounds 1 and 2, which is held on the Lake
Moolvalya region on the Colorado River in Parker, Arizona. This
temporary

safety zone is necessary to provide for the safety of the participants,
crew, spectators, sponsor vessels, and other users of the waterway.
This event involves powerboats racing along a circular course. The size
of the boats varies from ten to 16 feet in length. Approximately 90 to
130 boats will be participating in this event. The sponsor will provide
two patrol and rescue boats and two river closure boats.

Discussion of Proposed Rule

    The Coast Guard proposes establishing a safety zone that will be
enforced from 6 a.m. to 6 p.m. on May 1, 2009 through May 3, 2009. This
safety zone is necessary to provide for the safety of the crews,
spectators, participants, and other vessels and users of the waterway.
Persons and vessels will be prohibited from entering into, transiting
through, or anchoring within this safety zone unless authorized by the
Captain of the Port, or his designated representative. The limits of
this temporary safety zone are the portion of the Colorado River from
Headgate Dam to 0.5 miles north of Blue Water Marina, Parker, Arizona.

Regulatory Analyses

    We developed this proposed rule after considering numerous statutes
and executive orders related to rulemaking. Below we summarize our
analyses based on 13 of these statutes or executive orders.

Regulatory Planning and Review

    This proposed rule is not a significant regulatory action under
section 3(f) of Executive Order 12866, Regulatory Planning and Review,
and does not require an assessment of potential costs and benefits
under section 6(a)(3) of that Order. The Office of Management and
Budget has not reviewed it under that Order. We expect the economic
impact of this proposed rule to be so minimal that a full Regulatory
Evaluation is unnecessary. This determination is based on the size and
location of the safety zone. Commercial vessels will not be hindered by
the safety zone. Recreational vessels will not be allowed to transit
through the established safety zone during the specified times unless
authorized to do so by the Captain of the Port or his designated
representative.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this proposed rule would have a significant economic
impact on a substantial number of small entities. 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 proposed
rule would not have a significant economic impact on a substantial
number of small entities.
    This proposed rule would affect the following entities, some of
which might be small entities: The owners or operators of vessels
intending to transit or anchor in a portion of the Colorado River from
6 a.m. to 6 p.m. on May 1, 2009 through May 3, 2009.
    This safety zone would not have a significant economic impact on a
substantial number of small entities for the following reasons.
Although the safety zone would apply to the entire width of the river,
traffic would be allowed to pass through the zone with the permission
of the Coast Guard patrol commander. Before the effective period, the
Coast Guard will publish a local notice to mariners (LNM).
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this rule would have
a significant economic impact on it, please submit a comment (see
ADDRESSES) explaining why you think it qualifies and how and to what
degree this rule would economically affect it.

Assistance for Small Entities

    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 proposed rule so that they can better
evaluate its effects on them and participate in the rulemaking. 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 Petty Officer Kristen Beer,
USCG, Waterway Management, U.S. Coast Guard Sector San Diego at (619)
278-7262. The Coast Guard will not retaliate against small entities
that question or complain about this proposed rule or any policy or
action of the Coast Guard.

Collection of Information

    This proposed rule would call for no new collection of information
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520.).

Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on State or local
governments and would either preempt State law or impose a substantial
direct cost of compliance on them. We have analyzed this proposed rule
under that Order and have determined that it does not have implications
for federalism.

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 or more in any
one year. Though this proposed rule would not result in such an
expenditure, we do discuss the effects of this rule elsewhere in this
preamble.

Taking of Private Property

    This proposed rule would not effect a taking of private property or
otherwise have taking implications under Executive Order 12630,
Governmental Actions and Interference with Constitutionally Protected
Property Rights.

Civil Justice Reform

    This proposed rule meets applicable standards in sections 3(a) and
3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize
litigation, eliminate ambiguity, and reduce burden.

Protection of Children

    We have analyzed this proposed rule under Executive Order 13045,
Protection of Children from Environmental Health Risks and Safety
Risks. This rule is not an economically significant rule and would not
create an environmental risk to health or risk to safety that might
disproportionately affect children.

Indian Tribal Governments

    This proposed rule does not have tribal implications under
Executive Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it would 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.

Energy Effects

    We have analyzed this proposed rule under Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy Supply,

Distribution, or Use. We have determined that it is not a ``significant
energy action'' under that order because it is not a ``significant
regulatory action'' under Executive Order 12866 and is not likely to
have a significant adverse effect on the supply, distribution, or use
of energy. The Administrator of the Office of Information and
Regulatory Affairs has not designated it as a significant energy
action. Therefore, it does not require a Statement of Energy Effects
under Executive Order 13211.

Technical Standards

    The National Technology Transfer and Advancement Act (NTTAA) (15
U.S.C. 272 note) directs agencies to use voluntary consensus standards
in their regulatory activities unless the agency provides Congress,
through the Office of Management and Budget, with an explanation of why
using these standards would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., specifications of materials, performance, design, or
operation; test methods; sampling procedures; and related management
systems practices) that are developed or adopted by voluntary consensus
standards bodies.
    This proposed rule does not use technical standards. Therefore, we
did not consider the use of voluntary consensus standards.

Environment

    We have analyzed this proposed rule under Department of Homeland
Security Management Directive 5100.1 and Commandant Instruction
M16475.lD, which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and
have made a preliminary determination under the Instruction that this
action is not likely to have a significant effect on the human
environment. An environmental analysis checklist supporting this
preliminary determination is available in the docket where indicated
under ADDRESSES. We seek any comments or information that may lead to
the discovery of a significant environmental impact from this proposed
rule.

List of Subjects in 33 CFR Part 165

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

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

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

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

    Authority: 33 U.S.C. 1226, 1231; 46 U.S.C. Chapter 701, 3306,
3703; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, 160.5; Pub.
L. 107-295, 116 Stat. 2064; Department of Homeland Security
Delegation No. 0170.1.

    2. Add a new temporary zone Sec.  165.T11-138 to read as follows:

Sec.  165.T11-138  Safety Zone; Blue Water Resort and Casino APBA
National Tour Rounds 1 & 2; Colorado River, Parker, AZ.

    (a) Location. The limits of this temporary safety zone are the
portion of the Colorado River from Headgate Dam to 0.5 miles north of
the Bluewater Marine in Parker, Arizona.
    (b) Enforcement Period. This section will be enforced from 6 a.m.
to 6 p.m. on May 1, 2009 through May 3, 2009. If the event concludes
prior to the scheduled termination time, the Captain of the Port will
cease enforcement of this safety zone and will announce that fact via
Broadcast Notice to Mariners.
    (c) Definitions. The following definition applies to this section:
Designated representative, means any commissioned, warrant, and petty
officers of the Coast Guard on board Coast Guard, Coast Guard
Auxiliary, and local, state, and federal law enforcement vessels who
have been authorized to act on the behalf of the Captain of the Port.
    (d) Regulations. (1) Entry into, transit through or anchoring
within this safety zone is prohibited unless authorized by the Captain
of the Port of San Diego or his designated on-scene representative.
    (2) Mariners requesting permission to transit through the safety
zone may request authorization to do so from the Patrol Commander
(PATCOM). The PATCOM may be contacted on VHF-FM Channel 83.
    (3) All persons and vessels shall comply with the instructions of
the Coast Guard Captain of the Port or the designated representative.
    (4) Upon being hailed by U.S. Coast Guard patrol personnel by
siren, radio, flashing light, or other means, the operator of a vessel
shall proceed as directed.
    (5) The Coast Guard may be assisted by other federal, state, or
local agencies.

    Dated: February 3, 2009.
T.H. Farris,
Captain, U.S. Coast Guard, Captain of the Port San Diego.
[FR Doc. E9-4069 Filed 2-25-09; 8:45 am]

BILLING CODE 4910-15-P


[Federal Register Volume 77, Number 205 (Tuesday, October 23, 2012)]
[Rules and Regulations]
[Pages 64715-64718]
[FR Doc No: 2012-25989]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 522, 524, 529, and 558

[Docket No. FDA-2012-N-0002]

New Animal Drugs; Approvals; Changes of Sponsor; Change of
Sponsor's Name; Change of Sponsor's Address; Alfaxalone; Ivermectin and
Clorsulon; Narasin; Triptorelin

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval actions for new animal drug
applications (NADAs) and abbreviated new animal drug applications
(ANADAs) during September 2012. FDA is also informing the public of the
availability of summaries the basis of approval and of environmental
review documents, where applicable. The animal drug regulations are
also being amended to reflect a change of sponsorship for four
ophthalmic ointments, a change of sponsor's name, and a change of
sponsor's address.

DATES: This rule is effective October 23, 2012.

FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for
Veterinary Medicine (HFV-6), Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: FDA is amending the animal drug regulations
to reflect approval actions during September 2012, as listed in table
1. With respect to these actions, FDA is also informing the public of
the availability, where applicable, of documentation of environmental
review required under the National Environmental Policy Act (NEPA) and,
for actions requiring review of safety or effectiveness data, summaries
of the basis of approval (FOI Summaries) under the Freedom of
Information Act (FOIA). These public documents may be seen in the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, between 9 a.m. and 4
p.m., Monday through Friday. Persons with access to the Internet may
obtain these documents through the Center for Veterinary Medicine's
FOIA Electronic Reading Room. FOI Summaries may be found listed by
application number at: http://www.fda.gov/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/FOIADrugSummaries/default.htm. Environmental
Assessments (EAs) and Finding Of No Serious Impacts (FONSIs) may be
found listed by the established name of the active pharmaceutical
ingredient at: http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/EnvironmentalAssessments/ucm300656.htm.
    Also, Fougera Pharmaceuticals, Inc., P.O. Box 2006, 60 Baylis Rd.,
Melville, NY 11747, has informed FDA that it has transferred ownership
of, and all rights and interest in, NADA 065-015 for VETROPOLYCIN HC
(bacitracin zinc, polymyxin B sulfate, neomycin sulfate, and
hydrocortisone) Ophthalmic Ointment, NADA 065-016 for VETROPOLYCIN
(bacitracin zinc, neomycin sulfate, and polymyxin B sulfate) Ophthalmic
Ointment, NADA 065-460 for VETROCLORICIN (chloramphenicol) Ophthalmic
Ointment, and ANADA 200-273 for VETRO-GEN (gentamicin sulfate)
Ophthalmic Ointment to Dechra Ltd., Dechra House, Jamage Industrial
Estate, Talke Pits, Stoke-on-Trent, Staffordshire, ST7 1XW, United
Kingdom. Accordingly, the Agency is amending the regulations in 21 CFR
part 524 to reflect these changes.
    In addition, UDL Laboratories, Inc., 12720 Dairy Ashford Rd., Sugar
Land, TX 77478, has informed FDA that it has changed its name to Mylan
Institutional, Inc., and ECO LLC, 8209 Hollister Ave., Las Vegas, NV
89131 has informed FDA of a change of address to 344 Nassau St.,
Princeton, NJ 08540. Accordingly, the Agency is amending the
regulations in 21 CFR 510.600(c) to reflect these changes.

                                      Table 1--Original and Supplemental NADAs and ANADAs Approved During July 2012
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                             New animal drug                               21 CFR
          NADA/  ANADA                   Sponsor              product name               Action           Section     FOIA  Summary       NEPA  Review
--------------------------------------------------------------------------------------------------------------------------------------------------------
141-339........................  JBS United Animal       OVUGEL (triptorelin     Original approval for    529.2620  yes..............  CE \1\
                                  Health II LLC, 322 S.   acetate).               the synchronization
                                  Main St., Sheridan,                             of time of
                                  IN 46069.                                       insemination in
                                                                                weaned sows to
                                                                                facilitate a single
                                                                                fixed-time artificial
                                                                                insemination.
141-340........................  Elanco Animal Health,   SKYCIS 100 (narasin)    Original approval for     558.363  yes..............  EA/
                                  A Division of Eli       Type A medicated        use in medicated feed                                FONSI \2\
                                  Lilly & Co., Lilly      article.                for increased rate of
                                  Corporate Center,                               weight gain and
                                  Indianapolis, IN                                improved feed
                                  46285.                                          efficiency in growing-
                                                                                finishing swine.
141-342........................  Jurox Pty. Ltd., 85     ALFAXAN (alfaxalone)    Original approval for      522.52  yes..............  CE \1\
                                  Gardiner Rd.,           Intravenous             the induction and
                                  Rutherford, NSW 2320,   Injectable Anesthetic   maintenance of
                                  Australia.              for Cats and Dogs.      anesthesia and for
                                                                                induction of
                                                                                anesthesia followed
                                                                                by maintenance with
                                                                                an inhalant
                                                                                anesthetic, in dogs
                                                                                and cats.

200-466........................  Sparhawk Laboratories,  SPARMECTIN Plus         Original approval as a   522.1193  yes..............  CE \1\
                                  Inc., 12340 Santa Fe    Clorsulon (ivermectin   generic copy of NADA
                                  Trail Dr., Ft.          and clorsulon)          140-833.
                                  Lenexa, KS 66215.       Injection for Cattle.
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\1\ The Agency has determined under 21 CFR 25.33 that this action is categorically excluded (CE) from the requirement to submit an EA or an
  environmental impact statement (EIS) because it is of a type that does not individually or cumulatively have a significant effect on the human
  environment.
\2\ Based on its review of an EA submitted by the sponsor, the Agency has concluded that this action will not have a significant impact on the human
  environment and that an EIS is not required. A FONSI has been prepared.

    This rule does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because it is a rule of ``particular applicability.''
Therefore, it is not subject to the congressional review requirements
in 5 U.S.C. 801-808.

List of Subjects

21 CFR Part 510

    Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.

21 CFR Parts 522, 524, and 529

    Animal drugs.

21 CFR Part 558

    Animal drugs, Animal feeds.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR parts 510,
522, 524, 529, and 558 are amended as follows:

PART 510--NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 510 continues to read as
follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.

0
2. Amend Sec.  510.600 as follows:
0
a. In the table in paragraph (c)(1), revise the entry for ``ECO LLC'';
alphabetically add entries for ``Jurox Pty. Ltd.'', ``JBS United Animal
Health II LLC'', and ``Mylan Institutional, Inc.''; and remove the
entry for ``UDL Laboratories, Inc.''; and
0
b. In the table in paragraph (c)(2), numerically add entries for
``049480'' and ``051233'' and revise the entries for ``051079'' and
``066916''.
    The additions and revisions read as follows:

Sec.  510.600  Names, addresses, and drug labeler codes of sponsors of
approved applications.

* * * * *
    (c) * * *
    (1) * * *

------------------------------------------------------------------------
                                                                  Drug
                    Firm name and address                       labeler
                                                                  code
------------------------------------------------------------------------

                              * * * * * * *
ECO LLC, 344 Nassau St., Princeton, NJ 08540.................     066916

                              * * * * * * *
JBS United Animal Health II LLC, 322 S. Main St., Sheridan,       051233
 IN 46069....................................................

                              * * * * * * *
Jurox Pty. Ltd., 85 Gardiner Rd., Rutherford, NSW 2320,           049480
 Australia...................................................

                              * * * * * * *
Mylan Institutional, Inc., 12720 Dairy Ashford Rd., Sugar         051079
 Land, TX 77478..............................................

                              * * * * * * *
------------------------------------------------------------------------

     (2) * * *

------------------------------------------------------------------------
         Drug labeler code                  Firm name and address
------------------------------------------------------------------------

                              * * * * * * *
049480............................  Jurox Pty. Ltd., 85 Gardiner Rd.,
                                     Rutherford, NSW 2320, Australia.

                              * * * * * * *
051079............................  Mylan Institutional, Inc., 12720
                                     Dairy Ashford Rd., Sugar Land, TX
                                     77478.

                              * * * * * * *
051233............................  JBS United Animal Health II LLC, 322
                                     S. Main St., Sheridan, IN 46069.

                              * * * * * * *
066916............................  ECO LLC, 344 Nassau St., Princeton,
                                     NJ 08540.

                              * * * * * * *
------------------------------------------------------------------------

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

0
3. The authority citation for 21 CFR part 522 continues to read as
follows:

    Authority: 21 U.S.C. 360b.

0
4. Add Sec.  522.52 to read as follows:

Sec.  522.52  Alfaxalone.

    (a) Specifications. Each milliliter contains 10 milligrams (mg)
alfaxalone.
    (b) Sponsor. See No. 049480 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in cats and dogs--(1) Amount--(i) Cats--(A)
Induction of general anesthesia. Administer by intravenous injection
over approximately 60 seconds or until clinical signs show the onset of
anesthesia, 2.2 to 9.7 mg/kilogram (kg) for cats that did not receive a
preanesthetic or 1.0 to 10.8 mg/kg for cats that received a
preanesthetic.
    (B) Maintenance of general anesthesia following induction.
Administer an intravenous bolus containing 1.1 to 1.3 mg/kg to provide
an additional 7 to 8 minutes of anesthesia in preanesthetized cats; a
dose containing 1.4 to 1.5 mg/kg provides an additional 3 to 5 minutes
anesthesia in unpreanesthetized cats.
    (ii) Dogs--(A) Induction of general anesthesia. Administer by
intravenous injection over approximately 60 seconds or until clinical
signs show the onset of anesthesia, 1.5 to 4.5 mg/kg for dogs that did
not receive a preanesthetic or 0.2 to 3.5 mg/kg for dogs that received
a preanesthetic.
    (B) Maintenance of general anesthesia following induction.
Administer an intravenous bolus containing 1.2 to 1.4 mg/kg to provide
an additional 6 to 8 minutes of anesthesia in preanesthetized dogs; a
dose of 1.5 to 2.2 mg/kg provides an additional 6 to 8 minutes of
anesthesia in unpreanesthetized dogs.
    (2) Indications for use. For the induction and maintenance of
anesthesia and for induction of anesthesia followed by maintenance with
an inhalant anesthetic, in dogs and cats.
    (3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.

0
5. In Sec.  522.1193, revise paragraph (b) to read as follows:

Sec.  522.1193  Ivermectin and clorsulon.

* * * * *
    (b) Sponsors. See Nos. 050604, 055529, and 058005 in Sec.
510.600(c) of this chapter.
* * * * *

PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

0
6. The authority citation for 21 CFR part 524 continues to read as
follows:

    Authority: 21 U.S.C. 360b.

Sec.  524.154  [Amended]

0
7. In Sec.  524.154, in paragraph (a)(2), remove ``025463'' and in its
place add ``043264''; and in paragraph (b)(3), remove the first
sentence.

Sec.  524.155  [Amended]

0
8. In Sec.  524.155, in paragraph (a)(2), remove ``025463'' and in its
place add ``043264''; and in paragraph (b)(3), remove the first and
second sentences.

Sec.  524.390  [Amended]

0
9. In Sec.  524.390, in paragraph (b), remove ``025463'' and in its
place add ``043264''.

Sec.  524.1044c  [Amended]

0
10. In Sec.  524.1044c, in paragraph (b), remove ``025463'' and in its
place add ``043264''.

PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

0
11. The authority citation for 21 CFR part 529 continues to read as
follows:

    Authority: 21 U.S.C. 360b.

0
12. Add Sec.  529.2620 to read as follows:

Sec.  529.2620  Triptorelin.

    (a) Specifications. Each milliliter of gel contains 100 micrograms
(mcg) triptorelin as triptorelin acetate.
    (b) Sponsor. See No. 051233 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in swine--(1) Amount. Administer 200 mcg
intravaginally approximately 96 hours after weaning.
    (2) Indications for use. For the synchronization of time of
insemination in weaned sows to facilitate a single fixed-time
artificial insemination.
    (3) Limitations. Not approved for use in gilts. Safety and
effectiveness have not been evaluated in these animals. Should not be
used in sows with obvious reproductive tract abnormalities.

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

0
13. The authority citation for 21 CFR part 558 continues to read as
follows:

    Authority: 21 U.S.C. 360b, 371.

0
14. In Sec.  558.363, add paragraphs (a)(8) and (c); revise paragraph
(d)(1)(xi)(B); redesignate paragraph (d)(2) as paragraph (d)(3); and
add new paragraph (d)(2) to read as follows:

Sec.  558.363  Narasin.

    (a) * * *
    (8) To 000986: 45.4 grams per pound for use as in paragraph (d)(2)
of this section.
* * * * *
    (c) Special considerations. An expiration date of 2 months (8
weeks) is required for narasin Type C medicated swine feeds.
    (d) * * *
    (1) * * *
    (xi) * * *
    (B) Limitations. For broiler chickens only. Feed continuously as
sole ration. Do not allow adult turkeys, horses, or other equines
access to formulations containing narasin. Ingestion of narasin by
these species has been fatal. Narasin and tylosin as provided by 000986
in Sec.  510.600(c) of this chapter.
    (2) Growing-finishing swine--(i) Amount per ton. Narasin, 13.6 to
27.2 grams.
    (A) Indications for use. For increased rate of weight gain when fed
for at least 4 weeks.
    (B) Limitations. Feed continuously for at least 4 weeks to swine
during the growing-finishing period as the sole ration. No increased
benefit in rate of weight gain has been shown when narasin
concentrations in the diet are greater than 13.6 g/ton. Effectiveness
has not been demonstrated when fed for durations less than 4 weeks. Do
not allow adult turkeys, horses, or other equines access to narasin
formulations. Ingestion of narasin by these species has been fatal. Not
approved for use in breeding animals because safety and effectiveness
have not been evaluated in these animals. Swine being fed with narasin
should not have access to feeds containing pleuromutilins (e.g.,
tiamulin) as adverse reactions may occur. If signs of toxicity occur,
discontinue use.
    (ii) Amount per ton. Narasin, 18.1 to 27.2 grams.
    (A) Indications for use. For increased rate of weight gain and
improved feed efficiency when fed for at least 4 weeks.
    (B) Limitations. Feed continuously for at least 4 weeks to swine
during the growing-finishing period as the sole ration. No increased
benefit in rate of weight gain has been shown when narasin
concentrations in the diet are greater than 13.6 g/ton. Effectiveness
has not been demonstrated when fed for durations less than 4 weeks. Do
not allow adult turkeys, horses, or other equines access to narasin
formulations. Ingestion of narasin by these species has been fatal. Not
approved for use in

breeding animals because safety and effectiveness have not been
evaluated in these animals. Swine being fed with narasin should not
have access to feeds containing pleuromutilins (e.g., tiamulin) as
adverse reactions may occur. If signs of toxicity occur, discontinue
use.
* * * * *

    Dated: October 17, 2012.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2012-25989 Filed 10-22-12; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 85, Number 188 (Monday, September 28, 2020)]
[Notices]
[Pages 60854-60855]
[FR Doc No: 2020-21270]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-89949; File No. SR-NSCC-2020-003]

Self-Regulatory Organizations; National Securities Clearing
Corporation; Notice of Designation of Longer Period for Commission
Action on Proceedings To Determine Whether To Approve or Disapprove a
Proposed Rule Change To Enhance National Securities Clearing
Corporation's Haircut-Based Volatility Charge Applicable to Illiquid
Securities and UITs and Make Certain Other Changes to Procedure XV

September 22, 2020.
    On March 16, 2020, National Securities Clearing Corporation
(``NSCC'') filed with the Securities and Exchange Commission
(``Commission'') proposed rule change SR-NSCC-2020-003 (``Proposed Rule
Change'') pursuant to Section 19(b)(1) of the Securities Exchange Act
of 1934 (``Act'') \1\ and Rule 19b-4 thereunder.\2\ The Proposed Rule
Change was published for comment in the Federal Register on March 31,
2020.\3\ The Commission received

comment letters on the Proposed Rule Change.\4\
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ Securities Exchange Act Release No. 88474 (March 25, 2020),
85 FR 17910 (March 31, 2020) (SR-NSCC-2020-003) (``Notice''). NSCC
also filed the proposal contained in the Proposed Rule Change as
advance notice SR-FICC-2020-802 (``Advance Notice'') with the
Commission pursuant to Section 806(e)(1) of the Dodd-Frank Wall
Street Reform and Consumer Protection Act entitled the Payment,
Clearing, and Settlement Supervision Act of 2010 (``Clearing
Supervision Act''). 12 U.S.C. 5465(e)(1); 17 CFR 240.19b-4(n)(1)(i).
Notice of filing of the Advance Notice was published for comment in
the Federal Register on April 15, 2020. Securities Exchange Act
Release No. 88615 (April 9, 2020), 85 FR 21037 (April 15, 2020) (SR-
NSCC-2020-802). The proposal contained in the Proposed Rule Change
and the Advance Notice shall not take effect until all regulatory
actions required with respect to the proposal are completed.
    \4\ Letter from Christopher R. Doubek, CEO, Alpine Securities
Corporation (April 21, 2020); Letter from John Busacca, Founder,
Securities Industry Professional Association (April 23, 2020);
Letter from Charles F. Lek, Lek Securities Corporation (April 30,
2020); Letter from James C. Snow, President/CCO, Wilson-Davis & Co.,
Inc. (May 1, 2020), all available at https://www.sec.gov/comments/sr-nscc-2020-003/srnscc2020003.htm.
---------------------------------------------------------------------------

    On May 21, 2020, pursuant to Section 19(b)(2) of the Act,\5\ the
Commission designated a longer period within which to approve,
disapprove, or institute proceedings to determine whether to approve or
disapprove the Proposed Rule Change.\6\ On June 24, 2020, the
Commission instituted proceedings pursuant to Section 19(b)(2)(B) of
the Act,\7\ to determine whether to approve or disapprove the Proposed
Rule Change.\8\ The Commission received additional comment letters on
the Proposed Rule Change.\9\
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78s(b)(2).
    \6\ Securities Exchange Act Release No. 88885 (May 15, 2020), 85
FR 31007 (May 21, 2020) (SR-NSCC-2020-003).
    \7\ 15 U.S.C. 78s(b)(2)(B).
    \8\ Securities Exchange Act Release No. 89145 (June 24, 2020),
85 FR 39244 (June 30, 2020) (SR-NSCC-2020-003).
    \9\ Letter from Daniel Zinn, General Counsel, and Cass Sanford,
Associate General Counsel, OTC Markets Group Inc. (June 26, 2020);
Letter from Kim Unger, CEO/Executive Director, The Security Traders
Association of New York, Inc. (June 30, 2020); Letter from Daniel
Zinn, General Counsel, and Cass Sanford, Associate General Counsel,
OTC Markets Group Inc. (July 21, 2020); Letter from James C. Snow,
CCO, Wilson-Davis & Co., Inc. (July 29, 2020); Letter from Timothy
J. Cuddihy, Managing Director, DTCC Financial Risk Management
(September 3, 2020) all available at https://www.sec.gov/comments/sr-nscc-2020-003/srnscc2020003.htm.
---------------------------------------------------------------------------

    Section 19(b)(2) of the Act \10\ provides that proceedings to
determine whether to approve or disapprove a proposed rule change must
be concluded within 180 days of the date of publication of notice of
filing of the proposed rule change. The time for conclusion of the
proceedings may be extended for up to 60 days if the Commission
determines that a longer period is appropriate and publishes the
reasons for such determination.\11\ The 180th day after publication of
the Notice in the Federal Register is September 27, 2020.
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78s(b)(2).
    \11\ 15 U.S.C. 78s(b)(2)(B)(ii)(II).
---------------------------------------------------------------------------

    The Commission is extending the period for Commission action on the
Proposed Rule Change. The Commission finds that it is appropriate to
designate a longer period within which to take action on the Proposed
Rule Change so that the Commission has sufficient time to consider the
issues raised by the Proposed Rule Change and to take action on the
Proposed Rule Change. Accordingly, pursuant to Section
19(b)(2)(B)(ii)(II) of the Act,\12\ the Commission designates November
26, 2020, as the date by which the Commission should either approve or
disapprove the Proposed Rule Change SR-NSCC-2020-003.
---------------------------------------------------------------------------

    \12\ Id.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\13\
---------------------------------------------------------------------------

    \13\ 17 CFR 200.30-3(a)(57).
---------------------------------------------------------------------------

J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2020-21270 Filed 9-25-20; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 78, Number 72 (Monday, April 15, 2013)]
[Notices]
[Pages 22357-22360]
[FR Doc No: 2013-08726]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-69354; File No. SR-MIAX-2013-15]

Self-Regulatory Organizations; Miami International Securities
Exchange LLC; Order Approving, on an Accelerated Basis, Proposed Rule
Change Relating to Limit Up Limit Down Functionality

April 9, 2013.

I. Introduction

    On March 25, 2013, Miami International Securities Exchange LLC (the
``Exchange'' or ``MIAX'') filed with the Securities and Exchange
Commission (``Commission''), pursuant to Section 19(b)(1)\1\ of the
Securities Exchange Act of 1934 (``Act''),\2\ and Rule 19b-4
thereunder,\3\ a proposed rule change to provide for how the Exchange
proposes to treat market-making quoting obligations in response to the
Regulation NMS Plan to Address Extraordinary Market Volatility. The
proposed rule change was published for comment in the Federal Register
on March 29, 2013.\4\ On April 8, 2013, the Exchange submitted
Amendment No. 1 to the proposed rule change.\5\ The Commission received
no comment letters on the proposal. This order approves the proposed
rule change on an accelerated basis.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
    \4\ See Securities Exchange Act Release No. 692347 (March 25,
2013), 78 FR 19344 (``Notice'').
    \5\ In Amendment No. 1, the Exchange removed language from
proposed Rule 530(h) to clarify that its treatment of options
overlying securities that are subject to a trading pause in the
Limit Up-Limit Down context is intended to be the same as what is
currently set forth in Exchange Rule 504(c), which provides
generally for the treatment of options overlying securities that are
subject to a trading pause. Because the changes made in Amendment
No. 1 do not materially alter the substance of the proposed rule
change or raise any novel regulatory issues, Amendment No. 1 is not
subject to notice and comment.
---------------------------------------------------------------------------

II. Background

    On May 6, 2010, the U.S. equity markets experienced a severe
disruption that, among other things, resulted in the prices of a large
number of individual securities suddenly declining by significant
amounts in a very short time period before suddenly reversing to prices
consistent with their pre-decline levels.\6\ This severe price
volatility led to a large number of trades being executed at
temporarily depressed prices, including many that were more than 60%
away from pre-decline prices. One response to the events of May 6,
2010, was the development of the single-stock circuit breaker pilot
program, which was implemented through a series of rule filings by the
equity exchanges and by FINRA.\7\ The single-stock circuit breaker was
designed to reduce extraordinary market volatility in NMS stocks by
imposing a five-minute trading pause when a trade was executed at a
price outside of a specified percentage threshold.\8\
---------------------------------------------------------------------------

    \6\ The events of May 6 are described more fully in a joint
report by the staffs of the Commodity Futures Trading Commission
(``CFTC'') and the Commission. See Report of the Staffs of the CFTC
and SEC to the Joint Advisory Committee on Emerging Regulatory
Issues, ``Findings Regarding the Market Events of May 6, 2010,''
dated September 30, 2010, available at http://www.sec.gov/news/studies/2010/marketevents-report.pdf.
    \7\ For further discussion on the development of the single-
stock circuit breaker pilot program, see Securities Exchange Act
Release No. 67091 (May 31, 2012), 77 FR 33498 (June 6, 2012)
(``Limit Up-Limit Down Plan'' or ``Plan'').
    \8\ See Securities Exchange Act Release Nos. 62884 (September
10, 2010), 75 FR 56618 (September 16, 2010) and Securities Exchange
Act Release No. 62883 (September 10, 2010), 75 FR 56608 (September
16, 2010) (SR-FINRA-2010-033) (describing the ``second stage'' of
the single-stock circuit breaker pilot) and Securities Exchange Act
Release No. 64735 (June 23, 2011), 76 FR 38243 (June 29, 2011)
(describing the ``third stage'' of the single-stock circuit breaker
pilot).
---------------------------------------------------------------------------

    To replace the single-stock circuit breaker pilot program, the
equity exchanges filed a National Market System Plan\9\ pursuant to
Section 11A of the Act,\10\ and Rule 608 thereunder,\11\ which featured
a ``limit up-limit down'' mechanism (as amended, the ``Limit Up-Limit
Down Plan'' or ``Plan'').
---------------------------------------------------------------------------

    \9\ NYSE Euronext filed on behalf of New York Stock Exchange LLC
(``NYSE''), NYSE Amex LLC (``NYSE Amex''), and NYSE Arca, Inc.
(``NYSE Arca''), and the parties to the proposed National Market
System Plan, BATS Exchange, Inc., BATS Y-Exchange, Inc., Chicago
Board Options Exchange, Incorporated (``CBOE''), Chicago Stock
Exchange, Inc., EDGA Exchange, Inc., EDGX Exchange, Inc., Financial
Industry Regulatory Authority, Inc., NASDAQ OMX BX, Inc., NASDAQ OMX
PHLX LLC, the Nasdaq Stock Market LLC, and National Stock Exchange,
Inc. (collectively with NYSE, NYSE MKT, and NYSE Arca, the
``Participants''). On May 14, 2012, NYSE Amex filed a proposed rule
change on an immediately effective basis to change its name to NYSE
MKT LLC (``NYSE MKT''). See Securities Exchange Act Release No.
67037 (May 21, 2012) (SR-NYSEAmex-2012-32).
    \10\ 15 U.S.C. 78k-1.
    \11\ 17 CFR 242.608.
---------------------------------------------------------------------------

    The Plan sets forth requirements that are designed to prevent
trades in individual NMS stocks from occurring outside of the specified
price bands. The price bands consist of a lower price band and an upper
price band for each NMS stock. When one side of the market for an
individual security is outside the applicable price band, i.e., the
National Best Bid is below the Lower Price Band, or the National Best
Offer is above the Upper Price band, the Processors \12\ are required
to disseminate such National Best Bid or National Best Offer \13\ with
a flag identifying that quote as non-executable. When the other side of
the market reaches the applicable price band, i.e., the National Best
Offer reaches the lower price band, or the National Best Bid reaches
the upper price band, the market for an individual security enters a
15-second Limit State, and the Processors are required disseminate such
National Best Offer or National Best Bid with an appropriate flag
identifying it as a Limit State Quotation. Trading in that stock would

exit the Limit State if, within 15 seconds of entering the Limit State,
all Limit State Quotations were executed or canceled in their entirety.
If the market does not exit a Limit State within 15 seconds, then the
Primary Listing Exchange will declare a five-minute trading pause,
which is applicable to all markets trading the security.
---------------------------------------------------------------------------

    \12\ As used in the Plan, the Processor refers to the single
plan processor responsible for the consolidation of information for
an NMS Stock pursuant to Rule 603(b) of Regulation NMS under the
Exchange Act. See id.
    \13\ ``National Best Bid'' and ``National Best Offer'' has the
meaning provided in Rule 600(b)(42) of Regulation NMS under the
Exchange Act. See id.
---------------------------------------------------------------------------

    The Primary Listing Exchange may also declare a trading pause when
the stock is in a Straddle State, i.e., the National Best Bid (Offer)
is below (above) the Lower (Upper) Price Band and the NMS Stock is not
in a Limit State. In order to declare a trading pause in this scenario,
the Primary Listing Exchange must determine that trading in that stock
deviates from normal trading characteristics such that declaring a
trading pause would support the Plan's goal to address extraordinary
market volatility.\14\
---------------------------------------------------------------------------

    \14\ As set forth in more detail in the Plan, all trading
centers would be required to establish, maintain, and enforce
written policies and procedures reasonably designed to prevent the
display of offers below the Lower Price Band and bids above the
Upper Price Band for an NMS Stock. The Processors would be able to
disseminate an offer below the Lower Price Band or bid above the
Upper Price Band that nevertheless may be inadvertently submitted
despite such reasonable policies and procedures, but with an
appropriate flag identifying it as non-executable; such bid or offer
would not be included in National Best Bid or National Best Offer
calculations. In addition, all trading centers would be required to
develop, maintain, and enforce policies and procedures reasonably
designed to prevent trades at prices outside the price bands, with
the exception of single-priced opening, reopening, and closing
transactions on the Primary Listing Exchange.
---------------------------------------------------------------------------

    On May 31, 2012, the Commission approved the Plan as a one-year
pilot, which shall be implemented in two phases.\15\ The first phase of
the Plan was implemented on April 8, 2013.\16\
---------------------------------------------------------------------------

    \15\ See ``Limit Up-Limit Down Plan,'' supra note 7. See also
Securities Exchange Act Release No. 68953 (February 20, 2013), 78 FR
13113 (February 26, 2013) (Second Amendment to Limit Up-Limit Down
Plan by BATS Exchange, Inc., BATS Y- Exchange, Inc., Chicago Board
Options Exchange, Inc., et al.) and Securities Exchange Act Release
No. 69062 (March 7, 2013), 78 FR 15757 (March 12, 2013) (Third
Amendment to Limit Up-Limit Down Plan by BATS Exchange, Inc., BATS
Y- Exchange, Inc., Chicago Board Options Exchange, Inc., et al.)
    \16\ See ``Second Amendment to Limit Up-Limit Down Plan,'' supra
note 15.
---------------------------------------------------------------------------

III. Description of the Proposal

1. Market Maker Quoting Obligations

    In light of the Plan, the Exchange has proposed to adopt Rule
530(f) to address market maker quoting obligations when an underlying
security enters a Limit or Straddle state. Specifically, MIAX proposed
in Rule 530(f)(1)(i)-(iv) to suspend, when the security underlying an
option is in a Limit or Straddle State, the following market maker
quoting obligations: (i) The bid/ask differential requirements set
forth in Exchange Rule 603(b)(4); (ii) the minimum quote size
requirement set forth in Exchange Rule 604(b)(2); (iii) the two-sided
quote requirement set forth in Exchange Rule 604(c); and (iv) the
continuous quote requirement set forth in Exchange Rule 604(e).
Concerning the calculation of a market maker's continuous quoting
obligation, the Exchange will exclude the amount of time an NMS stock
underlying a MIAX option is in a Limit State or Straddle State from the
total amount of time in the trading day when calculating the percentage
of the trading day MIAX Market Makers are required to quote.
    The Exchange represented that market makers should be relieved of
these quoting obligations during Limit and Straddle States because
during such periods, market makers could not be certain whether they
could buy or sell an underlying security, or if they could, at what
price or quantity. The Exchange's corresponding proposal to suspend the
maximum quotation spread requirement during Limit or Straddle States is
intended to encourage market makers to choose to provide liquidity
during such states. According to the Exchange, allowing options market
makers the flexibility to choose whether to enter quotes, and to do so
without restrictions on the bid-ask differential, the minimum size of
the quote, and the ability to enter one-sided quotes, is necessary to
encourage market makers to provide liquidity in options classes
overlying securities that may enter a Limit State or Straddle State.
The Exchange proposed Rule 530(f)(2) to make clear that a market
maker's relief from the quoting obligations described above shall
terminate when the Limit or Straddle state no longer exists in the
affected underlying stock.

2. Market Maker Participation Guarantees

    MIAX additionally proposed in Rule 530(f)(3) to maintain,
unchanged, its scheme concerning the priority of quotes and orders
during Limit and Straddle states. Specifically, MIAX has proposed to
keep the provisions of Exchange Rule 514 unaffected during Limit or
Straddle states when a market maker receives relief from its quoting
obligations.
    Exchange Rule 514 describes, among other things, priority of quotes
and orders on the Exchange, allocation methods used on the Exchange,
and participation guarantees granted to certain Market Makers. Rule
514(g) details the Primary Lead Market Maker (``PLMM'') participation
guarantee and Rule 514(h) describes the Directed Lead Market Maker
(``DLMM'') participation guarantee. The participation guarantees set
forth in Exchange Rule 514 only apply if the affected PLMM or DLMM has
submitted a priority quote at the NBBO. The Exchange represented that,
although proposed rule 530(f)(1) would relieve market makers, including
PLMMs and DLMMs, from their quoting obligations during Limit or
Straddle states, maintaining participation guarantees could encourage
market makers to provide liquidity at the NBBO during such states.

3. Priority Quotes

    Similarly, the Exchange proposed in Rule 530(g)(2)(i) to consider
all market maker quotes submitted during Limit or Straddle states that
result in an execution to be ``priority quotes,'' notwithstanding the
usual criteria governing priority quotes that would otherwise be
applicable under Rule 517(b).\17\ When a quote is deemed a priority
quote, it receives precedence for allocation purposes over all
``Professional Interest.'' \18\
---------------------------------------------------------------------------

    \17\ The otherwise applicable criteria governing priority quotes
are: (A) The bid/ask differential of a Market Maker's two-sided
quote pair must be valid width (no wider than the bid/ask
differentials outlined in Rule 603(b)(4)); (B) the initial size of
both of the Market Maker's bid and the offer must be in compliance
with the requirements of Rule 604(b)(2); (C) the bid/ask
differential of a Market Maker's two-sided quote pair must meet the
priority quote width requirements defined below in subparagraph (ii)
for each option; and (D) either of the following are true: (1) At
the time a locking or crossing quote or order enters the System, the
Market Maker's two-sided quote pair must be valid width for that
option and must have been resting on the Book; or (2) Immediately
prior to the time the Market Maker enters a new quote that locks or
crosses the MBBO, the Market Maker must have had a valid width quote
already existing (i.e., exclusive of the Market Maker's new
marketable quote or update) among his two-sided quotes for that
option. See Exchange Rule 517(b)(i).
    \18\ See Exchange Rule 517(b). ``Professional Interest'' is
defined in Exchange Rule 100 to include orders for the account of a
person or entity that is a broker or dealer in securities or places
more than 390 orders in listed options per day on average during a
calendar month for its own beneficial account(s).
---------------------------------------------------------------------------

    MIAX represented that the purpose of this proposed rule is to
provide an incentive for Market Makers to submit quotations during
Limit and Straddle states by affording their quotes priority quote
status, ensuring them of priority executions over professional interest
when they assume the risk of quoting at or near the NBBO during times
of extreme volatility. As with the participation guarantees, a market
maker quote is deemed a priority quote during such states only if it
participates in an execution at the NBBO.

4. Opening Process

    Proposed Rule 530(g) sets forth changes in the manner in which the
Exchange's System will function during Limit and Straddle States.
Specifically Proposed Rule 530(g)(1) describes the functionality of the
Exchange's Opening Process \19\ when a Straddle State or Limit State
occurs before and during the Opening Process.
---------------------------------------------------------------------------

    \19\ The Exchange's Opening Process is described in greater
detail in Exchange Rule 503.
---------------------------------------------------------------------------

    Proposed Rule 530(g)(1)(i) provides that Opening Process shall be
delayed for options overlying an NMS Stock that entered a Straddle
State or a Limit State prior to the opening of trading such overlying
options. As proposed, the Opening Process shall begin when such
Straddle or Limit State has ended and there is not a halt or Trading
Pause in effect. The Exchange therefore will not open an option
overlying an NMS Stock that is in a Limit State or Straddle State.
    Proposed Rule 530(g)(1)(ii) addresses scenarios where the
Exchange's Opening Process has started but not yet completed when the
underlying NMS Stock enters a Straddle or Limit State. When the
affected option is in the Opening Process but trading has not begun,
the Opening Process will be terminated if the underlying NMS Stock is
in a Limit or Straddle State. The Opening Process will begin anew in
the affected overlying options when such Limit or Straddle State has
ended and there is not a halt or Trading Pause in effect. Thus, if an
Opening Process is occurring, it will cease and the Exchange shall re-
commence the Opening Process from the beginning once the Limit or
Straddle State is no longer present.

5. Trading Pauses and Opening After a Trading Pause

    Proposed Rule 530(h) provides that the Exchange will halt trading
in options overlying an NMS Stock that is subject to a trading pause.
The Exchange clarified in Amendment No. 1 that proposed Rule 530(h) is
intended merely to clarify that current Exchange Rule 504(c)--the
generally applicable rule concerning the treatment of options overlying
securities subject to a trading pause--shall equally apply when an
underlying security becomes subject to a trading pause as a result of
the Plan.
    Proposed Rule 530(i) provides that the Exchange will open trading
following a trading pause pursuant to the Exchange's opening procedures
contained in Rule 503. Proposed Rule 530(i) further adds that the
Exchange may resume trading in options contracts overlying an affected
NMS Stock if trading on the Primary Listing Exchange has not resumed
within ten minutes of receipt of a trading pause and at least one
exchange has resumed trading in such NMS Stock.

IV. Discussion and Commission Findings

    After careful review, the Commission finds that the proposed rule
change is consistent with the requirements of the Act and rules and
regulations thereunder applicable to a national securities
exchange.\20\ In particular, the Commission finds that the proposed
rule change is consistent with Section 6(b)(5) of the Act,\21\ which,
among other things, requires a national securities exchange to be so
organized and have the capacity to be able to carry out the purposes of
the Act and to enforce compliance by its members and persons associated
with its members with the provisions of the Act, the rules and
regulations thereunder, and the rules of the exchange, and is 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 regulation, clearing, settling,
processing information with respect to, and 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.
---------------------------------------------------------------------------

    \20\ In approving the proposed rule changes, the Commission has
considered their impact on efficiency, competition, and capital
formation. See 15 U.S.C. 78c(f).
    \21\ 15 U.S.C. 78f(b).
---------------------------------------------------------------------------

    The Commission finds that the proposal to suspend a market maker's
obligations when the underlying security is in a Limit or Straddle
State is consistent with the Act. During a Limit or Straddle State,
there may not be a reliable price for the underlying security to serve
as a benchmark for market makers to price options. In addition, the
absence of an executable bid or offer for the underlying security will
make it more difficult for market makers to hedge the purchase or sale
of an option. Given these significant changes to the normal operating
conditions of market makers, the Commission finds that the Exchange's
decision to suspend a market maker's obligations in these limited
circumstances is consistent with the Act.
    The Commission notes, however, that the Plan was approved on a
pilot basis and its Participants will monitor how it is functioning in
the equity markets during the pilot period. To this end, the Commission
expects that, upon implementation of the Plan, the Exchange will
continue monitoring the quoting requirements that are being amended in
this proposed rule change and that it will determine if any necessary
adjustments are required to ensure that they remain consistent with the
Act.
    The Commission also finds that the proposal to maintain
participation guarantees and priority quote treatment for market makers
who participate in an execution at the NBBO during a Limit or Straddle
state is consistent with the Act. To the extent that market makers are
only eligible for such benefits if they are quoting at the best price
on the Exchange, this proposal is reasonably designed to incentivize
market makers to quote more aggressively when the underlying security
has entered into a limit up-limit down state than they might otherwise
quote, potentially providing additional liquidity and price discovery.
    Lastly, the Commission finds that the Exchange's proposals
concerning its Opening Process and use of trading halts when an
underlying security is subject to a trading pause are consistent with
the Act. The Exchange's proposal to delay its Opening Process for an
option if the underlying has entered a Limit or Straddle is reasonably
designed to avoid opening an option during a time when the price of the
underlying security may be uncertain.\22\ Similarly, the Commission
finds that it is reasonable for the Exchange to halt trading in an
option when the underlying security is subject to a trading pause under
the Plan. This element of the Exchange's proposal is consistent with
how the Exchange currently treats options when an underlying security
is subject to a trading pause,\23\ and is also consistent with the
practice of other exchanges in this respect.\24\
---------------------------------------------------------------------------

    \22\ The Exchange's proposal concerning its Opening Process is
also consistent with what other exchanges have proposed. See, e.g.,
Phlx Rule 1047(f)(i).
    \23\ See Exchange Rule 504(c).
    \24\ See, e.g., CBOE Rule 6.3.06; NYSE Arca Rule 6.65(b); Phlx
Rule 1047(e).
---------------------------------------------------------------------------

    In addition, the Commission finds good cause, pursuant to Section
19(b)(2) of the Act \25\ for approving the proposed rule change on an
accelerated basis. This proposal is related to the Plan, which became
operative on April 8, 2013. Accelerating approval will allow the
proposed rule change, and any attendant benefits, to take effect as
shortly after the Plan's implementation date as possible. Accordingly,
the

Commission finds that good cause exists for approving the proposed rule
change on an accelerated basis.
---------------------------------------------------------------------------

    \25\ 15 U.S.C. 78s(b)(2)
---------------------------------------------------------------------------

V. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the Act
\26\ that the proposed rule change (SR-MIAX-2013-15), as modified by
Amendment No. 1, is approved on an accelerated basis.
---------------------------------------------------------------------------

    \26\ 15 U.S.C. 78f(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\27\
---------------------------------------------------------------------------

    \27\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-08726 Filed 4-12-13; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: December 2, 2008 (Volume 73, Number 232)]
[Notices]
[Page 73317]
[DOCID:fr02de08-58]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 13289-000]

Delaware River Basin Commission; Notice of Preliminary Permit
Application Accepted for Filing and Soliciting Comments, Motions To
Intervene, and Competing Applications

November 25, 2008.
    On September 22, 2008 and supplemented on October 22, 2008, the
Delaware River Basin Commission filed an application, pursuant to
section 4(f) of the Federal Power Act, proposing to study the
feasibility of the Blue Marsh Dam Hydroelectric Project. The Blue Marsh
Dam Hydroelectric Project would be located on Tulpehocken Creek (a
tributary of the Schuylkill River) in Berks County, Pennsylvania.
    The proposed Blue Marsh Dam Hydroelectric project would consist of:
(1) An existing 98-foot-high, 1,775-foot-long rolled earth rock Blue
Marsh Dam; (2) an existing reservoir having a surface area of 1,147
acres, with a storage capacity of 22,897 acre-feet and a normal water
surface elevation of 290-feet National Geodetic Vertical Datum (NGVD);
(3) a proposed 496-foot-long, varying in diameter from 4-inches to 10-
foot horseshoe shape concrete penstock; (4) a proposed powerhouse
containing two 4.16-kilowatt generators; (5) a proposed 0.9-mile-long,
12.47-kilovolt transmission line; and appurtenant facilities. The Blue
Marsh Dam Hydroelectric Project is estimated to have an annual
generation of 5.3-gigawatt-hours, which would be sold to a local
utility.
    Applicant Contact: Ms. Carol R. Collier, Executive Director,
Delaware River Basin Commission, 25 State Police Drive, P.O. Box 7360-
0360, West Trenton, NJ 08628-0360, phone<PHONE_NUMBER>, ext. 200.
    FERC Contact: Patricia W. Gillis,<PHONE_NUMBER>.
    Deadline for filing comments, motions to intervene, competing
applications (without notices of intent), or notices of intent to file
competing applications: 60 days from the issuance of this notice.
Comments, motions to intervene, notices of intent, and competing
applications may be filed electronically via the Internet. See 18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
under the ``e-Filing'' link. If unable to be filed electronically,
documents may be paper-filed. To paper-file, an original and eight
copies should be mailed to: Kimberly D. Bose, Secretary, Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426. For
more information on how to submit these types of filings please go to
the Commission's Web site located at http://www.ferc.gov/filing-
comments.asp. More information about this project can be viewed or
printed on the ``eLibrary'' link of Commission's Web site at http://
www.ferc.gov/docs-filing/elibrary.asp. Enter the docket number (P-
13289) in the docket number field to access the document. For
assistance, call toll-free 1-866-208-3372.

Kimberly D. Bose,
Secretary.
[FR Doc. E8-28576 Filed 12-1-08; 8:45 am]

BILLING CODE 6717-01-P


Comment Info: =================

General Comment:Dear Mr. Zeller:

I am writing as an individual consumer to request an extension of the comment period for the Food and Drug Administration's ("FDA") Proposed Rule Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking and Prevention and Tobacco Control Act (the "Proposed Rule") published at 79 Fed. Reg. 23,142 and Federal Register No. 2014-09491. On behalf of myself, I am requesting that the comment period for the Proposed Rule be extended by the FDA for an additional 105 days, from its current 75-day period, to 180 days.

I feel very strongly that the proposed rule does not take into account the drastic impact that it will have on the American industry as a whole, decimating many small and medium sized businesses, handing the industry to Big Tobacco, and moving the mass of the manufacturing to the overseas market.  The Proposed Rule asks about a hundred different questions I might want to respond to. I want to provide my thoughts and comments on many of these issues, but my time to devote to researching and providing thoughtful comments on these important questions is limited. I have already spent many hours researching and dissecting these issues, but they take time. I know that the FDA took many years to even come up with the Proposed Rule, so I do not think it is at all unreasonable to allow the public a mere six months to comment on it. This is our only opportunity, as consumers, to provide our feedback.

I have successfully quit smoking traditional cigarettes for three weeks now without going through the traditional withdrawal symptoms.  My wife is VERY happy as she does not smoke and she is comfortable with me vaping next to her in the house on the couch when we watch TV together.   I feel very strongly about e-cigarettes as an alternative to combustible cigarettes. Quite simply, I firmly believe that they saved my life. I wish to provide you with my personal story, as well as science- and evidence-based responses to your questions so that you can take my comment into account. I realize that the FDA has the authority under 21 CFR 10.40 to extend this time frame and that the FDA has exercised this authority on numerous occasions in the past. I would therefore ask that you do so here, so that all stakeholders have the opportunity to provide their comments on this proposed regulation.

I appreciate your consideration of my request and am happy to discuss this issue with you further.