[Federal Register Volume 79, Number 61 (Monday, March 31, 2014)]
[Rules and Regulations]
[Pages 17859-17860]
[FR Doc No: 2014-06994]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

[Docket No. FDA-2014-N-0002]

Zoetis Inc., et al.; Withdrawal of Approval of New Animal Drug
Applications for Combination Drug Medicated Feeds Containing an
Arsenical Drug; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; correcting amendments.

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SUMMARY: The Food and Drug Administration (FDA) is correcting a
document amending the animal drug regulations to reflect the withdrawal
of approval of new animal drug applications (NADAs) that appeared in
the Federal Register of February 27, 2014 (79 FR 10976). That document
listed an NADA for which a withdrawal of approval (WOA) was not
intended and failed to remove all conditions of use associated with the
withdrawn NADAs. This correction is being made to improve the accuracy
of the animal drug regulations.

DATES: This correction is effective March 31, 2014.

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_ADDRESS>
SUPPLEMENTARY INFORMATION: FDA is correcting a document amending the
animal drug regulations to reflect the WOA of NADAs that appeared in
the Federal Register of February 27, 2014 (79 FR 10976). That document
listed an NADA for which a WOA was not intended and failed to remove
all

conditions of use associated with the withdrawn NADAs. This correction
is being made to improve the accuracy of the animal drug regulations.
    In the preamble in rule FR Doc. 2014-02617 published on February
27, 2014 (79 FR 10976), make the following corrections:
    On page 10976, in the second column, in the 4th line of the
``SUMMARY'' section, remove ``69'' and replace with ``68''.
    On page 10977, appearing near the end of the page, ``Huvepharma AD,
5th Floor, 3A Nikolay Haitov Str., 1113 Sofia, Bulgaria, has requested
that FDA withdraw approval of the following 16 NADAs and 8 ANADAs'', is
corrected to read ``Huvepharma AD, 5th Floor, 3A Nikolay Haitov Str.,
1113 Sofia, Bulgaria, has requested that FDA withdraw approval of the
following 15 NADAs and 8 ANADAs''; and on the same page in the table,
the entry ``013-461 3-NITRO (roxarsone)/AMPROL Plus (amprolium and
ethopabate).'' is removed. 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 in 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 part 558 is
corrected by making the following correcting amendments.

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

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

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

Sec.  558.195  [Amended]

0
2. In Sec.  558.195, remove paragraph (e)(1)(vii).

Sec.  558.355  [Amended]

0
3. In Sec.  558.355, remove and reserve paragraph (b)(3).

0
4. In Sec.  558.635, revise paragraphs (d)(4)(v), (d)(4)(vi), and
(d)(4)(vii) to read as follows:

Sec.  558.635  Virginiamycin.

* * * * *
    (d) * * *
    (4) * * *
    (v) Monensin as in Sec.  558.355.
    (vi) Salinomycin as in Sec.  558.550.
    (vii) Semduramicin as in Sec.  558.555.

    Dated: March 25, 2014.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2014-06994 Filed 3-28-14; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 81, Number 219 (Monday, November 14, 2016)]
[Notices]
[Pages 79558-79559]
[FR Doc No: 2016-27274]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2016-0092; Notice 1]

Mercedes-Benz USA, LLC, Receipt of Petition for Decision of
Inconsequential Noncompliance

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation (DOT).

ACTION: Receipt of petition.

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SUMMARY: Mercedes-Benz USA, LLC (MBUSA), has determined that certain
model year (MY) 2016 Mercedes GL-Class multipurpose passenger vehicles
do not fully comply with paragraph S4.3(d) of Federal Motor Vehicle
Safety Standard (FMVSS) No. 110, Tire Selection and Rims and Motor
Home/Recreation Vehicle Trailer Load Carrying Capacity Information for
Motor Vehicles with a GVWR of 4,536 kilograms (10,000 pounds) or Less.
MBUSA filed a report dated August 12, 2016, and amended it on August
29, 2016, pursuant to 49 CFR part 573, Defect and Noncompliance
Responsibility and Reports. MBUSA then petitioned NHTSA under 49 CFR
part 556 for a decision that the subject noncompliance is
inconsequential as it relates to motor vehicle safety.

DATES: The closing date for comments on the petition is December 14,
2016.

ADDRESSES: Interested persons are invited to submit written data,
views, and arguments on this petition. Comments must refer to the
docket and notice number cited in the title of this notice and be
submitted by any of the following methods:
     Mail: Send comments by mail addressed to U.S. Department
of Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590.
     Hand Deliver: Deliver comments by hand to U.S. Department
of Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590. The
Docket Section is open on weekdays from 10 a.m. to 5 p.m. except
Federal Holidays.
     Electronically: Submit comments electronically by logging
onto the Federal Docket Management System (FDMS) Web site at https://www.regulations.gov/. Follow the online instructions for submitting
comments.
     Comments may also be faxed to<PHONE_NUMBER>.
    Comments must be written in the English language, and be no greater
than

15 pages in length, although there is no limit to the length of
necessary attachments to the comments. If comments are submitted in
hard copy form, please ensure that two copies are provided. If you wish
to receive confirmation that comments you have submitted by mail were
received, please enclose a stamped, self-addressed postcard with the
comments. Note that all comments received will be posted without change
to https://www.regulations.gov, including any personal information
provided.
    The petition, supporting materials, and all comments received
before the close of business on the closing date indicated above will
be filed in the docket and will be considered. All comments and
supporting materials received after the closing date will also be filed
and will be considered to the extent possible.
    When the petition is granted or denied, notice of the decision will
also be published in the Federal Register pursuant to the authority
indicated at the end of this notice.
    All documents submitted to the docket may be viewed by anyone at
the address and times given above. The documents may also be viewed on
the Internet at https://www.regulations.gov by following the online
instructions for accessing the dockets. The docket ID number for this
petition is shown in the heading of this notice.
    DOT's complete Privacy Act Statement is available for review in a
Federal Register notice published on April 11, 2000, (65 FR 19477-78).

SUPPLEMENTARY INFORMATION:
    I. Overview: Pursuant to 49 U.S.C. 30118(d) and 30120(h) and their
implementing regulations at 49 CFR part 556, MBUSA submitted a petition
for an exemption from the notification and remedy requirements of 49
U.S.C. Chapter 301 on the basis that this noncompliance is
inconsequential as it relates to motor vehicle safety.
    This notice of receipt of MBUSA's petition is published under 49
U.S.C. 30118 and 30120 and does not represent any agency decision or
other exercise of judgement concerning the merits of the petition.
    II. Vehicles Involved: Affected are 2,917 of the following MY 2016
Mercedes-Benz GL-Class multipurpose passenger vehicles manufactured
between December 1, 2015, and February 5, 2016:
     GL 350 Bluetec 4Matic SUV (155 vehicles).
     GL 450 4Matic SUV (2,482 vehicles).
     GL 550 4Matic SUV (280 vehicles).
    III. Noncompliance: MBUSA explains that the noncompliance is due to
a labeling error. The subject vehicles are equipped with a spare tire,
size T155/80 R19 114M; however, the tire information placard affixed to
the vehicles' B-pillar incorrectly identifies the spare tire size as
T165/90 R19 119M. The placard therefore does not comply with
requirements specified in paragraph S4.3(d) of FMVSS No. 110.
    IV. Rule Text: Paragraph S4.3 of FMVSS No. 110 states, in pertinent
part:

    S4.3 Placard. Each vehicle, except for a trailer or incomplete
vehicle shall show the information specified in S4.3 (a) through
(g), and may show, at the manufacturer's option, the information
specified in S4.3 (h) through (i), on a placard permanently affixed
to the driver's side B-pillar. In each vehicle without a driver's
side B-pillar and two doors on the driver's side of the vehicle
opening in the opposite directions, the placard shall be affixed on
the forward edge of the rear side door . . .
    (d) Tire size designation, indicated by the headings ``size'' or
``original tire size'' or ``original size,'' and ``spare tire'' or
``spare,'' for the tires installed at the time of the first purchase
for purposes other than resale. For full size spare tires, the
statement ``see above'' may, at the manufacturer's option replace
the tire size designation. If no spare tire is provided, the word
``none'' must replace the tire size designation; . . .

    V. Summary of MBUSA's Petition: MBUSA described the subject
noncompliance and stated its belief that the noncompliance is
inconsequential as it relates to motor vehicle safety.
    In support of its petition, MBUSA stated the following:

    (a) Both tire sizes can be used on the vehicle. The spare tire
with the size of T165/90 R19 119M (the size stated on the B-pillar
label) is equipped on older models produced before November 2015.
The purpose of FMVSS No. 110 is to ``prevent tire overloading,'' see
40 CFR 571. S1, and no overloading will result from the incorrect
label because either tire size (the one stated on the label or the
one actually on the vehicle) can be used.
    (b) The tire pressure is the same for both spare tire sizes.
When checking the tire pressure for the spare tire, the customer
will find the correct tire pressure values on the label. Again, no
overloading will result from the incorrect label because the correct
tire pressure values are provided.
    (c) Information regarding the correct spare tire is available to
the vehicle owner. The vehicles are equipped with an Operator's
Manual which describes both spare tire sizes. Also, if a tire needs
to be replaced on the spare wheel, the dealer Electronic Parts
Catalogue (EPC) correctly specifies the proper tire part number.
Additionally, further assistance regarding the correct spare tire
can be provided by the customer assistance center.
    (d) The presumption that the issue described above will have an
inconsequential impact on safety is supported by field data: MBUSA
is not aware of any customer complaints, accidents, or injuries
alleged to have occurred as a result of this tire label discrepancy
in the United States.

    MBUSA concluded by expressing the belief that the subject
noncompliance is inconsequential as it relates to motor vehicle safety,
and that its petition to be exempted from providing notification of the
noncompliance, as required by 49 U.S.C. 30118, and a remedy for the
noncompliance, as required by 49 U.S.C. 30120, should be granted.
    NHTSA notes that the statutory provisions (49 U.S.C. 30118(d) and
30120(h)) that permit manufacturers to file petitions for a
determination of inconsequentiality allow NHTSA to exempt manufacturers
only from the duties found in sections 30118 and 30120, respectively,
to notify owners, purchasers, and dealers of a defect or noncompliance
and to remedy the defect or noncompliance. Therefore, any decision on
this petition only applies to the subject vehicles that MBUSA no longer
controlled at the time it determined that the noncompliance existed.
However, any decision on this petition does not relieve vehicle
distributors and dealers of the prohibitions on the sale, offer for
sale, or introduction or delivery for introduction into interstate
commerce of the noncompliant vehicles under their control after MBUSA
notified them that the subject noncompliance existed.

    Authority:  49 U.S.C. 30118, 30120: delegations of authority at
49 CFR 1.95 and 501.8.

Jeffrey M. Giuseppe,
Director, Office of Vehicle Safety Compliance.
[FR Doc. 2016-27274 Filed 11-10-16; 8:45 am]
 BILLING CODE 4910-59-P


[Federal Register: June 23, 2008 (Volume 73, Number 121)]
[Rules and Regulations]
[Page 35342-35344]
[DOCID:fr23jn08-6]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2008-0399]
RIN 1625-AA00

Safety Zone; San Diego Symphony Orchestra; San Diego, CA

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a safety zone, on the
navigable waters of the San Diego Bay in support of the San Diego
Symphony Opera fireworks display series. This temporary safety zone is
necessary to provide for the safety of the crew, spectators, 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: This rule is effective from 9 p.m. on June 14, 2008 through 10
p.m. on August 31, 2008.

ADDRESSES: Documents indicated in this preamble as being available in
the docket are part of docket USCG-2008-0399 and are available online
at http://www.regulations.gov. They are also available for inspection
or copying two locations: The 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, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays, and 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.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary 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 the docket, call Renee V. Wright, Program
Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Regulatory Information

    We did not publish a notice of proposed rulemaking (NPRM) for this
regulation. Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing an NPRM. The logistical details of the
fireworks show were not finalized nor presented to the Coast Guard in
enough time to draft and publish an NPRM. As such, the event would
occur before the rulemaking process was complete.
    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. The issuance of the final approval
and permitting was so recent that the rule would be made effective less
than 30 days after publication. In addition, it would be contrary to
the public interest not to publish this rule due to protection from
inherent dangers to the crew and public that are present from a
fireworks display.

Background and Purpose

    The San Diego Symphony Orchestra and Copley Symphony Hall is
sponsoring the San Diego Symphony Orchestra, which will include a
fireworks presentation from a barge in the San Diego Bay. The barge
will be located near the maritime navigational channel in the vicinity
of North Embarcadero. The safety zone will be a 150 yard radius around
the anchored firing barge. The sponsor will provide a chase boat to
patrol the safety zone and inform vessels of the safety zone. This
temporary safety zone is necessary to provide for the safety of the
crew, spectators, and other vessels and users of the waterway.

Discussion of Rule

    The Coast Guard is establishing a safety zone that would be
effective from 9 p.m. to 10 p.m. on June 14, June 27-28, July 4-6, July
11-13, July 18-20, July 24-26, August 1-3, August 8-10, August 15-16,
August 21-23, and August 29-31, 2008. The limits of the safety zone
would be a 150 yard radius around the anchored firing barge located at
approximately 32[deg]42'12'' N, 117[deg]10'01'' W.
    The safety zone is necessary to provide for the safety of the
crews, spectators, 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.

Regulatory Evaluation

    This 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
designated safety zone during the specified times.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this 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 rule will
not have a significant economic impact on a substantial number of small
entities.
    This rule will affect the following entities, some of which may be
small entities: The owners or operators of vessels intending to transit
or anchor in a portion of the San Diego Bay from 9 p.m. to 10 p.m. on
June 14, June 27-28, July 4-6, July 11-13, July 18-20, July 24-26,
August 1-3, August 8-10, August 15-16, August 21-23, and August 29-31,
2008.
    This safety zone will not have a significant economic impact on a
substantial number of small entities for the following reasons. This
rule will be in effect for only 1 hour late in the evening when vessel
traffic is low. Vessel traffic can pass safely around the safety zone.
Before the effective period, the Coast Guard will publish a local
notice to mariners (LNM) and will issue broadcast notice to mariners
(BNM) alerts via marine channel 16 VHF before the safety zone is
enforced.

Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we offer to assist small
entities in understanding the rule so that they can better evaluate its
effects on them and participate in the rulemaking process.
    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.

Collection of Information

    This rule calls 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 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 rule will not result in such an expenditure, we
do discuss the effects of this rule elsewhere in this preamble.

Taking of Private Property

    This rule will 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 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 rule under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and does not create an
environmental risk to health or risk to safety that may
disproportionately affect children.

Indian Tribal Governments

    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.

Energy Effects

    We have analyzed this 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 rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

Environment

    We have analyzed this rule under Commandant Instruction M16475.lD
which guides the Coast Guard in complying with the National
Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and
have concluded that there are no factors in this case that would limit
the use of a categorical exclusion under section

2.B.2 of the Instruction. Therefore, this rule is categorically
excluded, under figure 2-1, paragraph (34)(g), of the Instruction, from
further environmental documentation. A final ``Environmental Analysis
Check List'' and a final ``Categorical Exclusion Determination'' are
available in the docket where indicated under ADDRESSES.

List of Subjects in 33 CFR Part 165

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

Words of Issuance and Regulatory Text

0
For the reasons discussed in the preamble, the Coast Guard amends 33
CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCES AREAS

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

    Authority: 33 U.S.C. 1225, 1231; 46 U.S.C. Chapter 701; 50
U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Pub. L.
107-295, 116 Stat. 2064; Department of Homeland Security Delegation
No. 0170.1.

    2. A new temporary Sec.  165.T11-036 to read as follows:

Sec.  165.T11-036  Safety Zone; San Diego Symphony Orchestra; San
Diego, CA.

    (a) Location. The limits of the temporary safety zone would include
a 150 radius around the anchored firing barge located at approximately
32[deg]42'12'' N., 117[deg]10'01'' W.
    (b) Enforcement Period. This section will be enforced from 9 p.m.
to 10 p.m. on each of the following days: June 14, June 27-28, July 4-
6, July 11-13, July 18-20, July 24-26, August 1-3, August 8-10, August
15-16, August 21-23, and August 29-31, 2008. If the need for the safety
zone ends before the scheduled termination time, the Captain of the
Port will cease enforcement of this safety zone.
    (c) Definitions. The following definition applies to this section:
Designated representative means any commissioned, warrant, and petty
officer of the Coast Guard on board Coast Guard, Coast Guard Auxiliary,
and local, state, and federal law enforcement vessels who has been
authorized to act on the behalf of the Captain of the Port.
    (d) Regulations. (1) In accordance with the general regulations in
Sec.  165.23 of this part, entry into, transit through or anchoring
within this zone by all vessels is prohibited unless authorized by the
Captain of the Port San Diego or his designated 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 16.
    (3) All persons and vessels shall comply with the instructions of
the Coast Guard Captain of the Port or his 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: June 6, 2008.
D.L. LeBlanc,
Commander, U.S. Coast Guard, Acting Captain of the Port San Diego.
[FR Doc. E8-14045 Filed 6-20-08; 8:45 am]

BILLING CODE 4910-15-P


[Federal Register Volume 80, Number 117 (Thursday, June 18, 2015)]
[Notices]
[Pages 34939-34946]
[FR Doc No: 2015-14969]

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SECURITIES AND EXCHANGE COMMISSION

[Investment Company Act Release No. 31667; 812-14419]

New York Alaska ETF Management LLC, et al.; Notice of Application

June 12, 2015.
AGENCY: Securities and Exchange Commission (``Commission'').

ACTION: Notice of an application for an order under section 6(c) of the
Investment Company Act of 1940 (``Act'') for an exemption from sections
2(a)(32), 5(a)(1), 22(d) and 22(e) of the Act and rule 22c-1 under the
Act, under sections 6(c) and 17(b) of the Act for an exemption from
sections 17(a)(1) and (a)(2) of the Act, and under section 12(d)(1)(J)
of the Act for an exemption from sections 12(d)(1)(A) and (B) of the
Act.

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APPLICANTS: Plus Trust (``Trust''), New York Alaska ETF Management LLC
(``New York Alaska Management''), and Foreside Fund Services, LLC.
SUMMARY: Summary of Application: Applicants request an order that
permits: (a) Actively-managed series of certain open-end management
investment companies to issue shares (``Shares'') redeemable in large
aggregations only (``Creation Units''); (b) secondary market
transactions in Shares to occur at negotiated market prices; (c)
certain series to pay redemption proceeds, under certain circumstances,
more than seven days from the tender of Shares for redemption; (d)
certain affiliated persons of the series to deposit securities into,
and receive securities from, the series in connection with the purchase
and redemption of Creation Units; and (e) certain registered management
investment companies and unit investment trusts outside of the same
group of investment companies as the series to acquire Shares.

DATES: Filing Dates: The application was filed on January 23, 2015, and
amended on April 29, 2015.

HEARING OR NOTIFICATION OF HEARING: An order granting the requested
relief will be issued unless the Commission orders a hearing.
Interested persons may request a hearing by writing to the Commission's
Secretary and serving applicants with a copy of the request, personally
or by mail. Hearing requests should be received by the Commission by
5:30 p.m. on July 7, 2015, and should be accompanied by proof of
service on applicants, in the form of an affidavit or, for lawyers, a
certificate of service. Pursuant to rule 0-5 under the Act, hearing
requests should state the nature of the writer's interest, any facts
bearing upon the desirability of a hearing on the matter, the reason
for the request, and the issues contested. Persons who wish to be
notified of a hearing may request notification by writing to the
Commission's Secretary.

ADDRESSES: Secretary, U.S. Securities and Exchange Commission, 100 F
Street NE., Washington, DC 20549-1090. Applicants: Ofer Abarbanel, New
York Alaska ETF Management LLC, 535 Fifth Avenue, 4th Floor, New York,
NY 10017.

FOR FURTHER INFORMATION CONTACT: Robert H. Shapiro, Senior Counsel, at
(202) 551-7758 or Mary Kay Frech, Branch Chief, at<PHONE_NUMBER>
(Division of Investment Management, Chief Counsel's Office).

SUPPLEMENTARY INFORMATION: The following is a summary of the
application. The complete application may be obtained via the
Commission's Web site by searching for the file number, or for an
applicant using the Company name box, at http://www.sec.gov/search/search.htm or by calling<PHONE_NUMBER>.

Applicants' Representations

    1. The Trust is a Delaware statutory trust and is registered with
the Commission as an open-end management investment company. The Trust
is organized as a series fund with multiple series, but will initially
be comprised of a single series, the 1-3 Month Enhanced Short Duration
ETF, (the ``Initial Fund''). The Trust will be overseen by a board of
trustees (for any entity, ``Board''). Subject to market conditions,
applicants expect that the investment objective of the Initial Fund
will be to seek current income consistent with preservation of capital
and daily liquidity.
    2. New York Alaska Management, a Nevada limited liability company
registered as an investment adviser under the Investment Advisers Act
of 1940 (``Advisers Act''), will be the investment adviser to the
Initial Fund. The Adviser (as defined below), subject to the oversight
and authority of the Board, will develop the overall investment program
for each Fund (as defined below). The Adviser may enter into sub-
advisory agreements with one or more investment advisers, each of which
will act as sub-adviser to a Fund (each a ``Sub-Adviser''). Applicants
state that each Sub-Adviser will be registered, or not subject to
registration, under the Advisers Act.
    3. The Board will select and approve Foreside Fund Services, LLC, a
Delaware limited liability company, to act as the distributor and
principal underwriter of the Funds (the ``Initial Distributor'')
pursuant to a distribution agreement between the Initial Distributor
and the Trust. The Trust may also enter into additional distribution
agreements with one or more other broker or dealer registered under the
Securities Exchange Act of 1934 (the ``Exchange Act'' and such persons
registered under the Exchange Act, ``Brokers'') (each, a ``Future
Distributor'' and, together with the Initial Distributor, each, a
``Distributor''). The Distributors will act as distributor and
principal underwriter of one or more of the Funds and will distribute
Shares on an agency basis. The Distributor of any Fund may be an
affiliated person or an affiliated person of an affiliated person of
that Fund's Adviser and/or Sub-Advisers. No Distributor, Adviser, Sub-
Adviser, Trust, or Fund is, or will be, affiliated with any national
securities exchange, as defined in section 2(a)(26) of the Act (``Stock
Exchange'').
    4. Applicants request that the order apply not only to the Initial
Fund but also to any future series of the Trust as well as other future
open-end management companies offering Shares that may utilize active
management investment strategies (collectively, ``Future Funds''). Any
Future Fund will (a) be advised by New York Alaska Management or an
entity controlling, controlled by, or under common control with New
York Alaska Management (New York Alaska Management and each such other
entity and any successor thereto included in the term ``Adviser''),\1\
and (b) comply with the terms and conditions of the application.\2\ The
Initial Fund and Future Funds together are the ``Funds.'' \3\ Each Fund
will consist of a portfolio of securities (including fixed income
securities and/or equity securities) and/or currencies traded in the
U.S. and/or non-U.S. markets, and derivatives, other assets, and other
investment positions (``Portfolio Instruments'').\4\ Funds may invest
in ``Depositary Receipts.'' \5\ Each Fund will operate as an actively
managed exchange-traded fund (``ETF'').
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    \1\ For the purposes of the requested order, a ``successor'' is
limited to an entity that results from a reorganization into another
jurisdiction or a change in the type of business organization.
    \2\ Any Adviser to a Future Fund will be registered as an
investment adviser under the Advisers Act. All entities that
currently intend to rely on the order are named as applicants. Any
entity that relies on the order in the future will comply with the
terms and conditions of the application.
    \3\ Applicants further request that the order apply to any
Future Distributor of the Funds, which would be a Broker and would
comply with the terms and conditions of the application.
    \4\ If a Fund invests in derivatives, then (a) the Fund's Board
will periodically review and approve the Fund's use of derivatives
and how the Adviser assesses and manages risk with respect to the
Fund's use of derivatives and (b) the Fund's disclosure of its use
of derivatives in its offering documents and periodic reports will
be consistent with relevant Commission and staff guidance.
    \5\ Depositary Receipts are typically issued by a financial
institution, a ``depository,'' and evidence ownership in a security
or pool of securities that have been deposited with the depository.
A Fund will not invest in any Depositary Receipts that the Adviser
or Sub-Adviser deems to be illiquid or for which pricing information
is not readily available. No affiliated persons of applicants, any
Future Fund, any Adviser or any Sub-Adviser will serve as the
depositary bank for any Depositary Receipts held by a Fund.
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    5. Applicants request that any exemption under section 12(d)(1)(J)
apply to: (1) With respect to section 12(d)(1)(B), any Fund that is
currently or subsequently part of the same ``group of investment
companies'' as the Initial Fund within the meaning of section
12(d)(1)(G)(ii) of the Act as well as any principal underwriter for the
Funds and any Brokers selling Shares of a Fund to an Investing Fund (as
defined below); and (2) with respect to section 12(d)(1)(A), each
management investment company or unit investment trust registered under
the Act that is not part of the same ``group of investment companies''
as the Funds, and that enters into a FOF Participation Agreement (as
defined below) to acquire Shares of a Fund (such management investment
companies, ``Investing Management Companies,'' such unit investment
trusts, ``Investing Trusts,'' and Investing Management Companies and
Investing Trusts together, ``Investing Funds''). Investing Funds do not
include the Funds.\6\
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    \6\ An Investing Fund may rely on the order only to invest in
Funds and not in any other registered investment company.
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    6. Applicants anticipate that a Creation Unit will consist of a
fixed number of Shares (e.g., at least 25,000). Applicants anticipate
that the trading

price of a Share will range from $10 to $100. All orders to purchase
Creation Units must be placed with a Distributor by or through a party
that has entered into a participant agreement with the Distributor and
the transfer agent of the Fund (``Authorized Participant'') with
respect to the creation and redemption of Creation Units. An Authorized
Participant is either: (a) A Broker or other participant, in the
Continuous Net Settlement System of the National Securities Clearing
Corporation (``NSCC''), a clearing agency registered with the
Commission and affiliated with the Depository Trust Company (``DTC''),
or (b) a participant in the DTC (``DTC Participant''). An investor does
not have to be an Authorized Participant, but must place an order
through, and make appropriate arrangements with, an Authorized
Participant.
    7. In order to keep costs low and permit each Fund to be as fully
invested as possible, Shares will be purchased and redeemed in Creation
Units and generally on an in-kind basis. Except where the purchase or
redemption will include cash under the limited circumstances specified
below, purchasers will be required to purchase Creation Units by making
an in-kind deposit of specified instruments (``Deposit Instruments''),
and shareholders redeeming their Shares will receive an in-kind
transfer of specified instruments (``Redemption Instruments'').\7\ On
any given Business Day,\8\ the names and quantities of the instruments
that constitute the Deposit Instruments and the names and quantities of
the instruments that constitute the Redemption Instruments will be
identical, and these instruments may be referred to, in the case of
either a purchase or redemption, as the ``Creation Basket.'' In
addition, the Creation Basket will correspond pro rata to the positions
in a Fund's portfolio (including cash positions),\9\ except: (a) In the
case of bonds, for minor differences when it is impossible to break up
bonds beyond certain minimum sizes needed for transfer and settlement;
(b) for minor differences when rounding is necessary to eliminate
fractional shares or lots that are not tradeable round lots; \10\ or
(c) TBA Transactions,\11\ short positions and other positions that
cannot be transferred in kind \12\ will be excluded from the Creation
Basket.\13\ If there is a difference between NAV attributable to a
Creation Unit and the aggregate market value of the Creation Basket
exchanged for the Creation Unit, the party conveying instruments with
the lower value will also pay to the other an amount in cash equal to
that difference (the ``Cash Amount'').
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    \7\ The Funds must comply with the federal securities laws in
accepting Deposit Instruments and satisfying redemptions with
Redemption Instruments, including that the Deposit Instruments and
Redemption Instruments are sold in transactions that would be exempt
from registration under the Securities Act of 1933 (``Securities
Act''). In accepting Deposit Instruments and satisfying redemptions
with Redemption Instruments that are restricted securities eligible
for resale pursuant to Rule 144A under the Securities Act, the Funds
will comply with the conditions of Rule 144A.
    \8\ Each Fund will sell and redeem Creation Units on any day the
Fund is open, including as required by section 22(e) of the Act
(each, a ``Business Day'').
    \9\ The portfolio used for this purpose will be the same
portfolio used to calculate the Fund's net asset value (``NAV'') for
that Business Day.
    \10\ A tradeable round lot for a security will be the standard
unit of trading in that particular type of security in its primary
market.
    \11\ A TBA Transaction is a method of trading mortgage-backed
securities. In a TBA Transaction, the buyer and seller agree on
general trade parameters such as agency, settlement date, par amount
and price.
    \12\ This includes instruments that can be transferred in kind
only with the consent of the original counterparty to the extent the
Fund does not intend to seek such consents.
    \13\ Because these instruments will be excluded from the
Creation Basket, their value will be reflected in the determination
of the Cash Amount (defined below).
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    8. Purchases and redemptions of Creation Units may be made in whole
or in part on a cash basis, rather than in kind, solely under the
following circumstances: (a) To the extent there is a Cash Amount, as
described above; (b) if, on a given Business Day, the Fund announces
before the open of trading that all purchases, all redemptions or all
purchases and redemptions on that day will be made entirely in cash;
(c) if, upon receiving a purchase or redemption order from an
Authorized Participant, the Fund determines to require the purchase or
redemption, as applicable, to be made entirely in cash; (d) if, on a
given Business Day, the Fund requires all Authorized Participants
purchasing or redeeming Shares on that day to deposit or receive (as
applicable) cash in lieu of some or all of the Deposit Instruments or
Redemption Instruments, respectively, solely because: (i) Such
instruments are not eligible for transfer through either the NSCC or
DTC; or (ii) in the case of Funds holding non-U.S. investments
(``Global Funds''), such instruments are not eligible for trading due
to local trading restrictions, local restrictions on securities
transfers or other similar circumstances; or (e) if the Fund permits an
Authorized Participant to deposit or receive (as applicable) cash in
lieu of some or all of the Deposit Instruments or Redemption
Instruments, respectively, solely because: (i) Such instruments are, in
the case of the purchase of a Creation Unit, not available in
sufficient quantity; (ii) such instruments are not eligible for trading
by an Authorized Participant or the investor on whose behalf the
Authorized Participant is acting; or (iii) a holder of Shares of a
Global Fund would be subject to unfavorable income tax treatment if the
holder receives redemption proceeds in kind.\14\
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    \14\ A ``custom order'' is any purchase or redemption of Shares
made in whole or in part on a cash basis in reliance on clause
(e)(i) or (e)(ii).
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    9. Each Business Day, before the open of trading on a Stock
Exchange on which a Fund's Shares are listed, such Fund will cause to
be published through the NSCC the names and quantities of the
instruments comprising the Creation Basket, as well as the estimated
Cash Amount (if any), for that day. The published Creation Basket will
apply until a new Creation Basket is announced on the following
Business Day, and there will be no intra-day changes to the Creation
Basket except to correct errors in the published Creation Basket. The
Stock Exchange will disseminate every 15 seconds throughout the trading
day through the facilities of the Consolidated Tape Association an
amount representing, on a per Share basis, the sum of the current value
of the Portfolio Instruments that were publicly disclosed prior to the
commencement of trading in Shares on the Stock Exchange.
    10. A Fund may recoup the settlement costs charged by NSCC and DTC
by imposing a transaction fee on investors purchasing or redeeming
Creation Units (``Transaction Fee''). The Transaction Fee will be borne
only by purchasers and redeemers of Creation Units and will be limited
to amounts that have been determined appropriate by the Adviser to
defray the transaction expenses that will be incurred by a Fund when an
investor purchases or redeems Creation Units.\15\
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    \15\ In all cases, the Transaction Fee will be limited in
accordance with the requirements of the Commission applicable to
open-end management investment companies offering redeemable
securities.
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    11. All orders to purchase Creation Units will be placed with a
Distributor by or through an Authorized Participant and the Distributor
will transmit all purchase orders to the relevant Fund. The Distributor
will be responsible for delivering a prospectus (``Prospectus'') to
those persons purchasing Creation Units and for maintaining records of
both the orders placed with it and the confirmations of acceptance
furnished by it.
    12. Shares will be listed on a Stock Exchange and traded in the
secondary

market in the same manner as other equity securities and ETFs.
Applicants expect that the Stock Exchange where each Fund is listed
will select, designate or appoint one or more specialists or market
makers (collectively, ``Market Makers'') for the Shares of each
Fund.\16\ The price of Shares trading on the Stock Exchange will be
based on a current bid/offer in the secondary market. Transactions
involving the purchases and sales of Shares on the Stock Exchange will
be subject to customary brokerage commissions and charges.
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    \16\ If Shares are listed on The NASDAQ Stock Market LLC
(``Nasdaq'') or a similar electronic Stock Exchange (including NYSE
Arca), one or more member firms of that Stock Exchange will act as
Market Makers and maintain a market for Shares trading on that Stock
Exchange. On Nasdaq, no particular Market Maker would be
contractually obligated to make a market in Shares. However, the
listing requirements on Nasdaq, for example, stipulate that at least
two Market Makers must be registered in Shares to maintain a
listing. In addition, on Nasdaq and NYSE Arca, registered Market
Makers are required to make a continuous two-sided market or subject
themselves to regulatory sanctions. No Market Maker will be an
affiliated person or an affiliated person of an affiliated person,
of the Funds, except within the meaning of section 2(a)(3)(A) or (C)
of the Act due solely to ownership of Shares, as discussed below.
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    13. Applicants expect that purchasers of Creation Units will
include institutional investors and arbitrageurs. Market Makers, acting
in their unique role to provide a fair and orderly secondary market for
Shares, also may purchase Creation Units for use in their own market
making activities. Applicants expect that secondary market purchasers
of Shares will include both institutional and retail investors.\17\
Applicants expect that arbitrage opportunities created by the ability
to continually purchase or redeem Creation Units at NAV should ensure
that the Shares will not trade at a material discount or premium in
relation to their NAV.
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    \17\ Shares will be registered in book-entry form only and the
Funds will not issue Share certificates. DTC or its nominee will be
the record or registered owner of all outstanding Shares. Beneficial
ownership of Shares will be shown on the records of DTC or DTC
Participants.
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    14. Shares will not be individually redeemable and owners of Shares
may acquire those Shares from a Fund, or tender such shares for
redemption to the Fund, in Creation Units only. To redeem, an investor
must accumulate enough Shares to constitute a Creation Unit. Redemption
requests must be placed by or through an Authorized Participant.
    15. Neither the Trust nor any Fund will be marketed or otherwise
held out as a ``mutual fund.'' Instead, each Fund will be marketed as
an ``actively managed exchange-traded fund.'' No Fund marketing
materials (other than as required in the Prospectus) will reference an
``open-end fund'' or ``mutual fund,'' except to compare and contrast a
Fund with conventional mutual funds. In all marketing materials where
the features or method of obtaining, buying or selling Shares traded on
the Stock Exchange are described, there will be an appropriate
statement to the effect that Shares are not individually redeemable.
    16. The Funds' Web site, which will be publicly available prior to
the public offering of Shares, will include a Prospectus for each Fund
that may be downloaded and additional quantitative information updated
on a daily basis, including, on a per Share basis for each Fund, the
prior Business Day's NAV and the market closing price or mid-point of
the bid/ask spread at the time of the calculation of such NAV (``Bid/
Ask Price''),\18\ and a calculation of the premium or discount of the
market closing price or Bid/Ask Price against such NAV. On each
Business Day, before commencement of trading in Shares on the Stock
Exchange, the Fund will disclose on its Web site the identities and
quantities of the Portfolio Instruments held by the Fund (including any
short positions held in securities) that will form the basis for the
Fund's calculation of NAV at the end of the Business Day.\19\ The Web
site and information will be publicly available at no charge.
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    \18\ Applicants state that the Bid/Ask Price of a Fund will be
determined using the highest bid and the lowest offer on the Stock
Exchange as of the time of calculation of such Fund's NAV. The
records relating to Bid/Ask Prices will be retained by the Funds or
their service providers.
    \19\ Applicants note that under accounting procedures followed
by the Funds, trades made on the prior Business Day will be booked
and reflected in NAV on the current Business Day. Accordingly, each
Fund will be able to disclose at the beginning of the Business Day
the portfolio that will form the basis for its NAV calculation at
the end of such Business Day.
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Applicants' Legal Analysis

    1. Applicants request an order under section 6(c) of the Act for an
exemption from sections 2(a)(32), 5(a)(1), 22(d) and 22(e) of the Act
and rule 22c-1 under the Act, under sections 6(c) and 17(b) of the Act
for an exemption from sections 17(a)(1) and 17(a)(2) of the Act, and
under section 12(d)(1)(J) of the Act for an exemption from sections
12(d)(1)(A) and (B) of the Act.
    2. Section 6(c) of the Act provides that the Commission may exempt
any person, security or transaction, or any class of persons,
securities or transactions, from any provisions of the Act, if and to
the extent that such exemption is necessary or appropriate in the
public interest and consistent with the protection of investors and the
purposes fairly intended by the policy and provisions of the Act.
Section 17(b) of the Act authorizes the Commission to exempt a proposed
transaction from section 17(a) of the Act if evidence establishes that
the terms of the transaction, including the consideration to be paid or
received, are reasonable and fair and do not involve overreaching on
the part of any person concerned, and the proposed transaction is
consistent with the policies of the registered investment company and
the general provisions of the Act. Section 12(d)(1)(J) of the Act
provides that the Commission may exempt any person, security, or
transaction, or any class or classes of persons, securities or
transactions, from any provision of section 12(d)(1) if the exemption
is consistent with the public interest and the protection of investors.

Sections 2(a)(32) and 5(a)(1) of the Act

    3. Section 5(a)(1) of the Act defines an ``open-end company'' as a
management investment company that is offering for sale or has
outstanding any redeemable security of which it is the issuer. Section
2(a)(32) of the Act defines a redeemable security as any security,
other than short-term paper, under the terms of which the holder, upon
its presentation to the issuer, is entitled to receive approximately a
proportionate share of the issuer's current net assets, or the cash
equivalent. Because Shares will not be individually redeemable,
applicants request an order that would permit the Trust to register as
an open-end management investment company and redeem Shares in Creation
Units only. Applicants state that investors may purchase Shares in
Creation Units from each Fund and redeem Creation Units from each Fund.
Applicants further state that because the market price of Creation
Units will be disciplined by arbitrage opportunities, investors should
be able to sell Shares in the secondary market at prices that do not
vary materially from their NAV.

Section 22(d) of the Act and Rule 22c-1 Under the Act

    4. Section 22(d) of the Act, among other things, prohibits a dealer
from selling a redeemable security that is currently being offered to
the public by or through a principal underwriter, except at a current
public offering price described in the prospectus. Rule 22c-1 under the
Act generally requires that a dealer selling, redeeming, or
repurchasing a redeemable security do so only at a price based on the
NAV

next computed after receipt of a tender of such security for redemption
or of an order to purchase or sell such security. Applicants state that
secondary market trading in Shares will take place at negotiated
prices, not at a current offering price described in the Prospectus,
and not at a price based on NAV. Thus, purchases and sales of Shares in
the secondary market will not comply with section 22(d) of the Act and
rule 22c-1 under the Act. Applicants request an exemption under section
6(c) from these provisions to permit the Shares to trade at negotiated
prices.
    5. Applicants assert that the concerns sought to be addressed by
section 22(d) of the Act and rule 22c-1 under the Act with respect to
pricing are equally satisfied by the proposed method of pricing Shares.
Applicants maintain that while there is little legislative history
regarding section 22(d), its provisions, as well as those of rule 22c-
1, appear to have been designed to (a) prevent dilution caused by
certain riskless-trading schemes by principal underwriters and contract
dealers, (b) prevent unjust discrimination or preferential treatment
among buyers resulting from sales at different prices, and (c) assure
an orderly distribution system of investment company shares by
eliminating price competition from brokers offering shares at less than
the published sales price and repurchasing shares at more than the
published redemption price.
    6. Applicants believe that none of these purposes will be thwarted
by permitting Shares to trade in the secondary market at negotiated
prices. Applicants state that (a) secondary market trading in Shares
does not involve the Funds as parties and cannot result in dilution of
an investment in Shares, and (b) to the extent different prices exist
during a given trading day, or from day to day, such variances occur as
a result of third-party market forces, such as supply and demand, not
as a result of unjust or discriminatory manipulation. Therefore,
applicants assert that secondary market transactions in Shares will not
lead to discrimination or preferential treatment among purchasers.
Finally, applicants contend that the proposed distribution system will
be orderly because arbitrage activity should ensure that the difference
between the market price of Shares and their NAV remains narrow.

Section 22(e) of the Act

    7. Section 22(e) of the Act generally prohibits a registered
investment company from suspending the right of redemption or
postponing the date of payment of redemption proceeds for more than
seven days after the tender of a security for redemption. Applicants
observe that settlement of redemptions of Creation Units of Global
Funds is contingent not only on the settlement cycle of the U.S.
securities markets but also on the delivery cycles present in foreign
markets in which those Funds invest. Applicants have been advised that,
under certain circumstances, the delivery cycles for transferring
Portfolio Instruments to redeeming investors, coupled with local market
holiday schedules, will require a delivery process of up to 14 calendar
days. Applicants therefore request relief from section 22(e) in order
to provide payment or satisfaction of redemptions within the maximum
number of calendar days required for such payment or satisfaction in
the principal local markets where transactions in the Portfolio
Instruments of each Global Fund customarily clear and settle, but in
all cases no later than 14 calendar days following the tender of a
Creation Unit.\20\
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    \20\ Applicants acknowledge that no relief obtained from the
requirements of section 22(e) will affect any obligations that it
may otherwise have under rule 15c6-1 under the Exchange Act. Rule
15c6-1 requires that most securities transactions be settled within
three business days of the trade date.
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    8. Applicants submit that section 22(e) was designed to prevent
unreasonable, undisclosed and unforeseen delays in the actual payment
of redemption proceeds. Applicants state that allowing redemption
payments for Creation Units of a Fund to be made within a maximum of 14
calendar days would not be inconsistent with the spirit and intent of
section 22(e). Applicants state each Global Fund's statement of
additional information (``SAI'') will disclose those local holidays
(over the period of at least one year following the date of the SAI),
if any, that are expected to prevent the delivery of redemption
proceeds in seven calendar days and the maximum number of days needed
to deliver the proceeds for each affected Global Fund. Applicants are
not seeking relief from section 22(e) with respect to Global Funds that
do not affect redemptions in-kind.

Section 12(d)(1) of the Act

    9. Section 12(d)(1)(A) of the Act prohibits a registered investment
company from acquiring shares of an investment company if such
securities represent more than 3% of the total outstanding voting stock
of the acquired company, more than 5% of the total assets of the
acquiring company, or, together with the securities of any other
investment companies, more than 10% of the total assets of the
acquiring company. Section 12(d)(1)(B) of the Act prohibits a
registered open-end investment company, its principal underwriter, or
any other broker or dealer from selling its shares to another
investment company if the sale will cause the acquiring company to own
more than 3% of the acquired company's voting stock, or if the sale
will cause more than 10% of the acquired company's voting stock to be
owned by investment companies generally.
    10. Applicants request relief to permit Investing Funds to acquire
Shares in excess of the limits in section 12(d)(1)(A) of the Act and to
permit the Funds, their principal underwriters and any Brokers to sell
Shares to Investing Funds in excess of the limits in section
12(d)(l)(B) of the Act. Applicants submit that the proposed conditions
to the requested relief address the concerns underlying the limits in
section 12(d)(1), which include concerns about undue influence,
excessive layering of fees and overly complex structures.
    11. Applicants submit that their proposed conditions address any
concerns regarding the potential for undue influence. To limit the
control that an Investing Fund may have over a Fund, applicants propose
a condition prohibiting the adviser of an Investing Management Company
(``Investing Fund Adviser''), sponsor of an Investing Trust
(``Sponsor''), any person controlling, controlled by, or under common
control with the Investing Fund Adviser or Sponsor, and any investment
company or issuer that would be an investment company but for sections
3(c)(1) or 3(c)(7) of the Act that is advised or sponsored by the
Investing Fund Adviser, the Sponsor, or any person controlling,
controlled by, or under common control with the Investing Fund Adviser
or Sponsor (``Investing Fund's Advisory Group'') from controlling
(individually or in the aggregate) a Fund within the meaning of section
2(a)(9) of the Act. The same prohibition would apply to any sub-adviser
to an Investing Management Company (``Investing Fund Sub-Adviser''),
any person controlling, controlled by or under common control with the
Investing Fund Sub-Adviser, and any investment company or issuer that
would be an investment company but for sections 3(c)(1) or 3(c)(7) of
the Act (or portion of such investment company or issuer) advised or
sponsored by the Investing Fund Sub-Adviser or any person controlling,
controlled by or under common control with the Investing Fund Sub-
Adviser

(``Investing Fund's Sub-Advisory Group'').
    12. Applicants propose a condition to ensure that no Investing Fund
or Investing Fund Affiliate \21\ (except to the extent it is acting in
its capacity as an investment adviser to a Fund) will cause a Fund to
purchase a security in an offering of securities during the existence
of an underwriting or selling syndicate of which a principal
underwriter is an Underwriting Affiliate (``Affiliated Underwriting'').
An ``Underwriting Affiliate'' is a principal underwriter in any
underwriting or selling syndicate that is an officer, director, member
of an advisory board, Investing Fund Adviser, Investing Fund Sub-
Adviser, employee or Sponsor of the Investing Fund, or a person of
which any such officer, director, member of an advisory board,
Investing Fund Adviser, Investing Fund Sub-Adviser, employee or Sponsor
is an affiliated person (except any person whose relationship to the
Fund is covered by section 10(f) of the Act is not an Underwriting
Affiliate).
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    \21\ An ``Investing Fund Affiliate'' is any Investing Fund
Adviser, Investing Fund Sub-Adviser, Sponsor, promoter and principal
underwriter of an Investing Fund, and any person controlling,
controlled by or under common control with any of these entities.
``Fund Affiliate'' is an investment adviser, promoter, or principal
underwriter of a Fund or any person controlling, controlled by or
under common control with any of these entities.
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    13. Applicants propose several conditions to address the potential
for layering of fees. Applicants note that the Board of any Investing
Management Company, including a majority of the directors or trustees
who are not ``interested persons'' within the meaning of section
2(a)(19) of the Act (``independent directors or trustees''), will be
required to find that the advisory fees charged under the contract are
based on services provided that will be in addition to, rather than
duplicative of, services provided under the advisory contract of any
Fund in which the Investing Management Company may invest. Applicants
also state that any sales charges and/or service fees charged with
respect to shares of an Investing Fund will not exceed the limits
applicable to a fund of funds as set forth in NASD Conduct Rule
2830.\22\
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    \22\ Any reference to NASD Conduct Rule 2830 includes any
successor or replacement rule that may be adopted by the Financial
Industry Regulatory Authority (``FINRA'').
---------------------------------------------------------------------------

    14. Applicants submit that the proposed arrangement will not create
an overly complex fund structure. Applicants note that a Fund will be
prohibited from acquiring securities of any investment company or
company relying on section 3(c)(1) or 3(c)(7) of the Act in excess of
the limits contained in section 12(d)(1)(A) of the Act, except to the
extent permitted by exemptive relief from the Commission permitting the
Fund to purchase shares of other investment companies for short-term
cash management purposes.
    15. To ensure that an Investing Fund is aware of the terms and
conditions of the requested order, the Investing Funds must enter into
an agreement with the respective Funds (``FOF Participation
Agreement''). The FOF Participation Agreement will include an
acknowledgement from the Investing Fund that it may rely on the order
only to invest in a Fund and not in any other investment company.

Sections 17(a)(1) and (2) of the Act

    16. Section 17(a) of the Act generally prohibits an affiliated
person of a registered investment company, or an affiliated person of
such a person (``second tier affiliate''), from selling any security to
or purchasing any security from the company. Section 2(a)(3) of the Act
defines ``affiliated person'' to include any person directly or
indirectly owning, controlling, or holding with power to vote, 5% or
more of the outstanding voting securities of the other person and any
person directly or indirectly controlling, controlled by, or under
common control with, the other person. Section 2(a)(9) of the Act
defines ``control'' as the power to exercise a controlling influence
over the management or policies of a company and provides that a
control relationship will be presumed where one person owns more than
25% of another person's voting securities. Each Fund may be deemed to
be controlled by an Adviser and hence affiliated persons of each other.
In addition, the Funds may be deemed to be under common control with
any other registered investment company (or series thereof) advised by
an Adviser (an ``Affiliated Fund'').
    17. Applicants request an exemption under sections 6(c) and 17(b)
of the Act from sections 17(a)(1) and 17(a)(2) of the Act to permit in-
kind purchases and redemptions of Creation Units by persons that are
affiliated persons or second tier affiliates of the Funds solely by
virtue of one or more of the following: (a) Holding 5% or more, or in
excess of 25% of the outstanding Shares of one or more Funds; (b)
having an affiliation with a person with an ownership interest
described in (a); or (c) holding 5% or more, or more than 25% of the
Shares of one or more Affiliated Funds.\23\ Applicants also request an
exemption in order to permit a Fund to sell its Shares to and redeem
its Shares from, and engage in the in-kind transactions that would
accompany such sales and redemptions with, certain Investing Funds of
which the Funds are affiliated persons or second-tier affiliates.\24\
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    \23\ Applicants are not seeking relief from section 17(a) for,
and the requested relief will not apply to, transactions where a
Fund could be deemed an affiliated person, or an affiliated person
of an affiliated person, of an Investing Fund because an investment
adviser to the Funds is also an investment adviser to an Investing
Fund.
    \24\ Applicants expect most Investing Funds will purchase Shares
in the secondary market and will not purchase Creation Units
directly from a Fund. To the extent that purchases and sales of
Shares occur in the secondary market and not through principal
transactions directly between an Investing Fund and a Fund, relief
from section 17(a) would not be necessary. However, the requested
relief would apply to direct sales of Shares in Creation Units by a
Fund to an Investing Fund and redemptions of those Shares. The
requested relief is intended to also cover the in-kind transactions
that may accompany such sales and redemptions.
---------------------------------------------------------------------------

    18. Applicants assert that no useful purpose would be served by
prohibiting such affiliated persons from making in-kind purchases or
in-kind redemptions of Shares of a Fund in Creation Units. Absent the
unusual circumstances discussed in the application, the Deposit
Instruments and Redemption Instruments available for a Fund will be the
same for all purchases and redemptions, respectively, and will
correspond pro rata to the Fund's Portfolio Instruments. The deposit
procedures for in-kind purchases of Creation Units and the redemption
procedures for in-kind redemptions will be effected in exactly the same
manner for all purchases and redemptions, regardless of size or number.
Deposit Instruments and Redemption Instruments will be valued in the
same manner as those Portfolio Instruments currently held by the
relevant Funds, and the valuation of the Deposit Instruments and
Redemption Instruments will be made in the same manner and on the same
terms, regardless of the identity of the purchaser or redeemer.
Applicants do not believe that in-kind purchases and redemptions will
result in abusive self-dealing or overreaching of the Fund.
    19. Applicants also submit that the sale of Shares to and
redemption of Shares from an Investing Fund meets the standards for
relief under sections 17(b) and 6(c) of the Act. Applicants note that
any consideration paid for the purchase or redemption of Shares
directly from a Fund will be based on the NAV of the Fund in accordance
with policies and procedures set forth in the Fund's registration
statement.\25\ The

FOF Participation Agreement will require any Investing Fund that
purchases Creation Units directly from a Fund to represent that the
purchase of Creation Units from a Fund by an Investing Fund will be
accomplished in compliance with the investment restrictions of the
Investing Fund and will be consistent with the investment policies set
forth in the Investing Fund's registration statement. Applicants also
state that the proposed transactions are consistent with the general
purposes of the Act and appropriate in the public interest.
---------------------------------------------------------------------------

    \25\ Applicants acknowledge that the receipt of compensation by
(a) an affiliated person of an Investing Fund, or an affiliated
person of such person, for the purchase by the Investing Fund of
Shares of the Fund or (b) an affiliated person of a Fund, or an
affiliated person of such person, for the sale by the Fund of its
Shares to an Investing Fund, may be prohibited by section 17(e)(1)
of the Act. The FOF Participation Agreement also will include this
acknowledgment.
---------------------------------------------------------------------------

Applicants' Conditions

    Applicants agree that any order of the Commission granting the
requested relief will be subject to the following conditions:

A. ETF Relief

    1. As long as a Fund operates in reliance on the requested order,
the Shares of the Fund will be listed on a Stock Exchange.
    2. Neither the Trust nor any Fund will be advertised or marketed as
an open-end investment company or a mutual fund. Any advertising
material that describes the purchase or sale of Creation Units or
refers to redeemability will prominently disclose that the Shares are
not individually redeemable and that owners of the Shares may acquire
those Shares from the Fund and tender those Shares for redemption to
the Fund in Creation Units only.
    3. The Web site for the Funds, which is and will be publicly
accessible at no charge, will contain, on a per Share basis, for each
Fund the prior Business Day's NAV and the market closing price or Bid/
Ask Price, and a calculation of the premium or discount of the market
closing price or Bid/Ask Price against such NAV.
    4. On each Business Day, before commencement of trading in Shares
on the Stock Exchange, the Fund will disclose on its Web site the
identities and quantities of the Portfolio Instruments held by the Fund
that will form the basis for the Fund's calculation of NAV at the end
of the Business Day.
    5. Neither the Adviser nor any Sub-Adviser, directly or indirectly,
will cause any Authorized Participant (or any investor on whose behalf
an Authorized Participant may transact with the Fund) to acquire any
Deposit Instrument for the Fund through a transaction in which the Fund
could not engage directly.
    6. The requested relief to permit ETF operations will expire on the
effective date of any Commission rule under the Act that provides
relief permitting the operation of actively-managed exchange-traded
funds.

B. Section 12(d)(1) Relief

    1. The members of the Investing Fund's Advisory Group will not
control (individually or in the aggregate) a Fund within the meaning of
section 2(a)(9) of the Act. The members of the Investing Fund's Sub-
Advisory Group will not control (individually or in the aggregate) a
Fund within the meaning of section 2(a)(9) of the Act. If, as a result
of a decrease in the outstanding voting securities of a Fund, the
Investing Fund's Advisory Group or the Investing Fund's Sub-Advisory
Group, each in the aggregate, becomes a holder of more than 25 percent
of the outstanding voting securities of a Fund, it will vote its Shares
of the Fund in the same proportion as the vote of all other holders of
the Fund's Shares. This condition does not apply to the Investing
Fund's Sub-Advisory Group with respect to a Fund for which the
Investing Fund Sub-Adviser or a person controlling, controlled by or
under common control with the Investing Fund Sub-Adviser acts as the
investment adviser within the meaning of section 2(a)(20)(A) of the
Act.
    2. No Investing Fund or Investing Fund Affiliate will cause any
existing or potential investment by the Investing Fund in a Fund to
influence the terms of any services or transactions between the
Investing Fund or an Investing Fund Affiliate and the Fund or a Fund
Affiliate.
    3. The board of directors or trustees of an Investing Management
Company, including a majority of the independent directors or trustees,
will adopt procedures reasonably designed to ensure that the Investing
Fund Adviser and any Investing Fund Sub-Adviser are conducting the
investment program of the Investing Management Company without taking
into account any consideration received by the Investing Management
Company or an Investing Fund Affiliate from a Fund or a Fund Affiliate
in connection with any services or transactions.
    4. Once an investment by an Investing Fund in the Shares of a Fund
exceeds the limit in section 12(d)(1)(A)(i) of the Act, the Board of a
Fund, including a majority of the independent directors or trustees,
will determine that any consideration paid by the Fund to the Investing
Fund or an Investing Fund Affiliate in connection with any services or
transactions: (i) Is fair and reasonable in relation to the nature and
quality of the services and benefits received by the Fund; (ii) is
within the range of consideration that the Fund would be required to
pay to another unaffiliated entity in connection with the same services
or transactions; and (iii) does not involve overreaching on the part of
any person concerned. This condition does not apply with respect to any
services or transactions between a Fund and its investment adviser(s),
or any person controlling, controlled by or under common control with
such investment adviser(s).
    5. The Investing Fund Adviser, or Trustee or Sponsor, as
applicable, will waive fees otherwise payable to it by the Investing
Fund in an amount at least equal to any compensation (including fees
received pursuant to any plan adopted by a Fund under rule 12b-1 under
the Act) received from a Fund by the Investing Fund Adviser, or Trustee
or Sponsor, or an affiliated person of the Investing Fund Adviser, or
Trustee or Sponsor, other than any advisory fees paid to the Investing
Fund Adviser, or Trustee or Sponsor, or its affiliated person by the
Fund, in connection with the investment by the Investing Fund in the
Fund. Any Investing Fund Sub-Adviser will waive fees otherwise payable
to the Investing Fund Sub-Adviser, directly or indirectly, by the
Investing Management Company in an amount at least equal to any
compensation received from a Fund by the Investing Fund Sub-Adviser, or
an affiliated person of the Investing Fund Sub-Adviser, other than any
advisory fees paid to the Investing Fund Sub-Adviser or its affiliated
person by the Fund, in connection with the investment by the Investing
Management Company in the Fund made at the direction of the Investing
Fund Sub-Adviser. In the event that the Investing Fund Sub-Adviser
waives fees, the benefit of the waiver will be passed through to the
Investing Management Company.
    6. No Investing Fund or Investing Fund Affiliate (except to the
extent it is acting in its capacity as an investment adviser to a Fund)
will cause a Fund to purchase a security in an Affiliated Underwriting.
    7. The Board of a Fund, including a majority of the independent
directors or trustees, will adopt procedures reasonably designed to
monitor any purchases of securities by the Fund in an Affiliated
Underwriting, once an investment by an Investing Fund in the

securities of the Fund exceeds the limit of section 12(d)(1)(A)(i) of
the Act, including any purchases made directly from an Underwriting
Affiliate. The Board will review these purchases periodically, but no
less frequently than annually, to determine whether the purchases were
influenced by the investment by the Investing Fund in the Fund. The
Board will consider, among other things: (i) Whether the purchases were
consistent with the investment objectives and policies of the Fund;
(ii) how the performance of securities purchased in an Affiliated
Underwriting compares to the performance of comparable securities
purchased during a comparable period of time in underwritings other
than Affiliated Underwritings or to a benchmark such as a comparable
market index; and (iii) whether the amount of securities purchased by
the Fund in Affiliated Underwritings and the amount purchased directly
from an Underwriting Affiliate have changed significantly from prior
years. The Board will take any appropriate actions based on its review,
including, if appropriate, the institution of procedures designed to
assure that purchases of securities in Affiliated Underwritings are in
the best interest of shareholders of the Fund.
    8. Each Fund will maintain and preserve permanently in an easily
accessible place a written copy of the procedures described in the
preceding condition, and any modifications to such procedures, and will
maintain and preserve for a period of not less than six years from the
end of the fiscal year in which any purchase in an Affiliated
Underwriting occurred, the first two years in an easily accessible
place, a written record of each purchase of securities in Affiliated
Underwritings once an investment by an Investing Fund in the securities
of the Fund exceeds the limit of section 12(d)(1)(A)(i) of the Act,
setting forth from whom the securities were acquired, the identity of
the underwriting syndicate's members, the terms of the purchase, and
the information or materials upon which the Board's determinations were
made.
    9. Before investing in a Fund in excess of the limits in section
12(d)(1)(A)(i), an Investing Fund will execute a FOF Participation
Agreement with the Fund stating that their respective boards of
directors or trustees and their investment advisers, or Trustee and
Sponsor, as applicable, understand the terms and conditions of the
order, and agree to fulfill their responsibilities under the order. At
the time of its investment in Shares of a Fund in excess of the limit
in section 12(d)(1)(A)(i), an Investing Fund will notify the Fund of
the investment. At such time, the Investing Fund will also transmit to
the Fund a list of the names of each Investing Fund Affiliate and
Underwriting Affiliate. The Investing Fund will notify the Fund of any
changes to the list as soon as reasonably practicable after a change
occurs. The Fund and the Investing Fund will maintain and preserve a
copy of the order, the FOF Participation Agreement, and the list with
any updated information for the duration of the investment and for a
period of not less than six years thereafter, the first two years in an
easily accessible place.
    10. Before approving any advisory contract under section 15 of the
Act, the board of directors or trustees of each Investing Management
Company, including a majority of the independent directors or trustees,
will find that the advisory fees charged under such contract are based
on services provided that will be in addition to, rather than
duplicative of, the services provided under the advisory contract(s) of
any Fund in which the Investing Management Company may invest. These
findings and their basis will be recorded fully in the minute books of
the appropriate Investing Management Company.
    11. Any sales charges and/or service fees charged with respect to
shares of an Investing Fund will not exceed the limits applicable to a
fund of funds as set forth in NASD Conduct Rule 2830.
    12. No Fund relying on the section 12(d)(1) relief will acquire
securities of any investment company or company relying on section
3(c)(1) or 3(c)(7) of the Act in excess of the limits contained in
section 12(d)(1)(A) of the Act, except to the extent permitted by
exemptive relief from the Commission permitting the Fund to purchase
shares of other investment companies for short-term cash management
purposes.

    For the Commission, by the Division of Investment Management,
under delegated authority.
Robert W. Errett,
Deputy Secretary.
[FR Doc. 2015-14969 Filed 6-17-15; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 78, Number 152 (Wednesday, August 7, 2013)]
[Notices]
[Page 48177]
[FR Doc No: 2013-18694]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0883]

Purdue Pharma L.P.; Withdrawal of Approval of a New Drug
Application for Oxycontin

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of a new drug application (NDA) for OXYCONTIN (oxycodone hydrochloride)
Extended-Release Tablets, held by Purdue Pharma L.P. (Purdue), One
Stamford Forum, Stamford, CT 06901-3431. Purdue has voluntarily
requested that approval of this application (NDA 20-553) be withdrawn
and has waived its opportunity for a hearing.

DATES: Effective August 7, 2013.

FOR FURTHER INFORMATION CONTACT: Patrick Raulerson, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6368, Silver Spring, MD 20993-0002, 301-
796-3522.

SUPPLEMENTARY INFORMATION: FDA approved NDA 20-553 for OXYCONTIN
(oxycodone hydrochloride) Extended-Release Tablets, 10 milligrams (mg),
15 mg, 20 mg, 30 mg, 40 mg, 60 mg, 80 mg, and 160 mg, (original
OxyContin), on December 12, 1995. A reformulated version of these
products, OXYCONTIN (oxycodone hydrochloride) Extended-Release Tablets,
10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg, and 80 mg (reformulated
OxyContin), is the subject of NDA 22-272, also held by Purdue and
initially approved on April 5, 2010. Reformulated OxyContin was
developed with physicochemical properties that are intended to make the
tablet more difficult to manipulate for purposes of abuse or misuse.
Both original and reformulated OxyContin are opioid agonist products.
Original OxyContin was indicated for the management of moderate to
severe pain when a continuous, around-the-clock opioid analgesic is
needed for an extended period of time.
    In correspondence dated August 10, 2010, Purdue notified FDA that
it had ceased shipment of original OxyContin, and FDA subsequently
moved original OxyContin to the ``Discontinued Drug Product List''
section of the Orange Book. In a letter to FDA dated March 19, 2013,
Purdue requested that FDA withdraw approval of NDA 20-553 for original
OxyContin, noting that the original formulation of OxyContin was
subject to abuse and misuse, and that it was ``not possible to develop
labeling or REMS provisions that would create a positive risk/benefit
ratio for the original formulation of OxyContin.'' In that letter,
Purdue waived its right to a hearing.
    On April 18, 2013, FDA published notice of its determination that
original OxyContin, NDA 20-553, was withdrawn from sale for reasons of
safety or effectiveness (78 FR 23273). The notice concluded that
``[o]riginal OxyContin . . . poses an increased potential for abuse by
certain routes of administration, when compared to reformulated
OxyContin. Based on the totality of the data and information available
to the Agency at this time, FDA concludes that the benefits of original
OxyContin no longer outweigh its risks.''
    Under section 505(e) of the Federal Food, Drug, and Cosmetic Act
(the FD&C Act) (21 U.S.C. 355(e)), and under authority delegated by the
Commissioner to the Director, Center for Drug Evaluation and Research,
approval of NDA 20-553, and all amendments and supplements thereto, is
withdrawn (see DATES). Distribution of this product in interstate
commerce without an approved application is illegal and subject to
regulatory action (see sections 505(a) and 301(d) of the FD&C Act (21
U.S.C. 355(a) and 331(d)).

    Dated: July 30, 2013.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 2013-18694 Filed 8-6-13; 8:45 am]
BILLING CODE 4160-01-P


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

OFFICE OF

PREVENTION, PESTICIDES AND

TOXIC SUBSTANCES

February 29, 2008

MEMORANDUM

SUBJECT:	Flonicamid: Amendment to D347805 Human Health Risk Assessment for Proposed Uses on Root Vegetables (Except Sugarbeet; Subgroup 1B), Tuberous and Corm Vegetables (Subgroup 1C), Leafy Brassica Green Vegetables (Subgroup 5B), Turnip Greens, Hops and Okra. PC Code: 128016, Petition No: 6E7081, DP Barcode: D332317.

Section 3 Registration Action

Single Chemical Aggregate

FROM:	Sheila Piper, Risk Assessor

Alternative Risk Integration Assessment Team (ARIA)

Registration Branch (7505P)

			and

Amelia Acierto, Residue Chemist

Registration Action Branch 3 (RAB3)

Health Effects Division (7509P)

THROUGH:	Paula Deschamp, Chief

Registration Action Branch 3 (RAB3)

Health Effects Division (7509P)

TO:		Ann Sibold, PM Team #10

Insecticide Branch

	and

Sidney Jackson, IR-4

Registration Division (7505P)

This memorandum amends the Flonicamide Human Health Risk Assessment (D347805, S. Piper, 12/21/07 to include recommendation for a tolerance (16 ppm) for flonicamide residues on radish, tops.  The previous assessment concluded that a tolerance for radish tops was not needed for the proposed flonicamid use on subgroup 1B (root vegetable, except sugar beet).  With the exception of this error all the information contained in the 12/21/07 risk assessment document remains unchanged.

The amended tolerance recommendation is based on the following:  Sufficient residue data are available to support the tolerance for the combined residues of flonicamid, TFNA, TFNA-AM and TFNG in/on radish tops of 16 ppm.  In addition, a chronic dietary exposure assessment was conducted including the recommended tolerance level on radish top and it was concluded that the exposure to flonicamid is below HED’s level of concern for the general U.S. population and all population subgroups (DP #343466, A. M. Acierto, 11/8/07).

Recommendations

Provided a revised Section F is submitted, there are no residue chemistry issues that would preclude granting a registration for the requested uses of flonicamid on root vegetables (except sugar beets), tuberous and corm vegetables, leafy Brassica greens, turnip greens, hops, and okra, or establishment of tolerances for flonicamid residues as follows:

Tolerances to be established under 40 CFR 180.613(a)(1):

Brassica, leafy greens, subgroup 5B ……………….16 ppm

Hop, dried cones…………………………………....7.0 ppm

Okra	 ………………………………….…………0.40 ppm

Turnip, greens ………………………………………16 ppm

Radish, tops	16 ppm

Vegetable, root, except sugar beet, subgroup 1B	..0.60 ppm

Vegetable, tuberous and corm, subgroup 1C	…..   . 0.20 ppm

Tolerances to be revised under 40 CFR 180.613(a)(2):

Cattle, fat	0.03 ppm

Cattle, meat	0.08 ppm

Egg	0.04 ppm

Goat, fat	0.03 ppm

Goat, meat	0.08 ppm

Horse, fat	0.03 ppm

Horse, meat	0.08 ppm

Milk	0.03 ppm

Poultry, fat	0.03 ppm

Poultry, meat	0.03 ppm

Poultry, meat byproducts	0.03 ppm

Sheep, fat	0.03 ppm

Sheep, meat	0.08 ppm

Revised Tolerance Summary Table

A summary of the recommended tolerances for the combined residues of the insecticide flonicamid and its metabolites TFNA, TFNA-AM, and TFNG in/on the commodities is presented in Table 11.1 below.

Table 11.1. 	Tolerance Summary for Flonicamid

Commodity or Subgroup	Proposed Tolerance (ppm)	Established Tolerance (ppm)	Recommended Tolerance (ppm)	Comments; Correct Commodity Definition

Tolerances for combined residues of flonicamid and its metabolites TFNA, TFNA-AM, and TFNG

[40 CFR 180.613(a)(1)]:

Brassica, leafy greens, subgroup 5B	16	--	16

	Hop, dried cones	7.0	--	7.0

	Mustard greens	--	11	16	Residues in/on mustard greens will be covered by the tolerance for leafy Brassica green, subgroup 5B.

Okra	0.4	--	0.40

	Potato

0.20	None	Residues in/on potato will be covered by the tolerance for tuberous and corm vegetables, subgroup 1C.

Radish, tops	16	--	16

	Turnip, greens	16	--	16

	Vegetable, root, except sugar beet, subgroup 1B	0.45	--	0.60 Recommended tolerance based on crop field trial data

Vegetable, tuberous and corm, subgroup 1C	0.2	--	0.20

	Tolerances for combined residues of flonicamid and its metabolites TFNA-AM and TFNA in/on livestock commodities [40 CFR 180.613(a)(2)]:

Cattle, fat	--	0.02	0.03	Increased tolerances are needed to reflect combined limits of quantitation for all regulated residues.

Cattle, meat	--	0.05	0.08

	Egg	--	0.03	0.04	An increased tolerance is needed to account for all regulated residues.

Goat, fat	--	0.02	0.03	Increased tolerances are needed to reflect combined limits of quantitation for all regulated residues.

Goat, meat	--	0.05	0.08

	Horse, fat	--	0.02	0.03	Increased tolerances are needed to reflect combined limits of quantitation for all regulated residues.

Horse, meat	--	0.05	0.08

	Milk	--	0.02	0.03	Increased tolerances are needed to reflect combined limits of quantitation for all regulated residues.

Poultry, fat	--	0.02	0.03

	Poultry, meat	--	0.02	0.03

	Poultry, meat byproducts	--	0.02	0.03

	Sheep, fat	--	0.02	0.03

	Sheep, meat	--	0.05	0.08

References

HED/ARIA Flonicamid: Human Health Risk Assessment (D347805, S Piper, 12/21/07)

HED Amendment to Residue Chemistry Summary Document (D330980, A Acierto, 2/21/08)

HED Flonicamid Risk Assessment (D289592, J. Arthur, 5/25/2005)

HED Residue Chemistry Summary Document (D343466, A. Acierto, 11/08/2007)

HED Dietary Exposure & Risk Assessment (D332316, A. Acierto, 11/16/2007)

EFED Estimated Environmental Concentrations (D330894, D331070, and D331027, L.              Shanaman, 10/29/2007)

HED/ARIA Occupational Exposure Memo (D345362, M. Dow, 10/16/2007)

Page   PAGE  4  of   NUMPAGES  4


[Federal Register Volume 83, Number 189 (Friday, September 28, 2018)]
[Notices]
[Page 49077]
[FR Doc No: 2018-21129]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL18-203-000]

Notice of Complaint; Owensboro Municipal Utilities v. Louisville
Gas and Electric Company, Kentucky Utilities Company

    Take notice that on September 21, 2018, pursuant to sections 206,
306, 309, and 316 \1\ of the Federal Power Act and Rule 206 of the
Federal Energy Regulatory Commission's (Commission) Rules of Practice
and Procedure,\2\ Owensboro Municipal Utilities (Complainant) filed a
formal complaint against Louisville Gas and Electric Company and
Kentucky Utilities Company, (Respondents) alleging that, from February
1, 2018 forward, Respondents violated and continue to violate its joint
obligation, under First Revised Rate Schedule No. 402 to reimburse
Complainant for pancaked transmission service charges incurred to
Drive-Out from the Midcontinent Independent System Operator, all as
more fully explained in the complaint.
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    \1\ 16 U.S.C. 825e, 824e, 825h, and 825o.
    \2\ 18 CFR 385.206.
---------------------------------------------------------------------------

    The Complainants certify that copies of the Complaint were served
on contacts for Respondents.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. The Respondent's
answer and all interventions, or protests must be filed on or before
the comment date. The Respondent's answer, motions to intervene, and
protests must be served on the Complainants.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the eFiling link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 5 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street NE, Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
eLibrary link and is available for electronic review in the
Commission's Public Reference Room in Washington, DC. There is an
eSubscription link on the website that enables subscribers to receive
email notification when a document is added to a subscribed docket(s).
For assistance with any FERC Online service, please email
[email protected], or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern Time on October 11, 2018.

    Dated: September 24, 2018.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2018-21129 Filed 9-27-18; 8:45 am]
 BILLING CODE 6717-01-P