protection values for total nitrogen and total phosphorus unless each
of the following eutrophication impacts are evaluated and none occur
within the same three-year rolling average period: (I) Eutrophication-
related mortality or morbidity events for fish and other aquatic
organisms, (II) An excursion from the DO or pH criteria in Missouri
water quality standards applicable for Clean Water Act purposes, (III)
Cyanobacteria counts equal to or greater than 100,000 cells per ml,
(IV) Observed shifts in aquatic diversity directly attributable to
eutrophication, or (V) Excessive levels of mineral turbidity that
consistently limit algal productivity during the period May 1--
September 30, or Secchi disk measurements of turbidity equal to or less
than EPA's recommended Level III Ecoregions IX (1.53 m) or IX (2.86 m).
(c) Applicability
    (1) The combined criterion in paragraph (b) of this section applies
to waters discussed in paragraph (a) of this section and applies
concurrently with other applicable water quality criteria.
    (2) The combined criterion established in this section is subject
to Missouri's general rules of applicability in the same way and to the
same extent as state-adopted and EPA-approved water quality criteria
when applied to the waters discussed in paragraph (a).
    (d) Effective date. Section 131.47 will be in effect [date 60 days
after publication of final rule].

[FR Doc. 2017-27621 Filed 12-26-17; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 87, Number 55 (Tuesday, March 22, 2022)]
[Notices]
[Pages 16201-16212]
[FR Doc No: 2022-06009]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0335]

Authorization of Emergency Use of a Biological Product During the
COVID-19 Pandemic; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
issuance of an Emergency Use Authorization (EUA) (the Authorization)
under the Federal Food, Drug, and Cosmetic Act (FD&C Act) for use
during the COVID-19 pandemic. FDA has issued one Authorization for a
biological product as requested by Eli Lilly and Company (Lilly). The
Authorization contains, among other things, conditions on the emergency
use of the authorized product. The Authorization follows the February
4, 2020, determination by the Secretary of Health and Human Services
(HHS) that there is a public health emergency that has a significant
potential to affect national security or the health and security of
U.S. citizens living abroad and that involves a novel (new)
coronavirus. The virus, now named SARS-CoV-2, causes the illness COVID-
19. On the basis of such determination, the Secretary of HHS declared
on March 27, 2020, that circumstances exist justifying the
authorization of emergency use of drugs and biological products during
the COVID-19 pandemic, pursuant to the FD&C Act, subject to the terms
of any authorization issued under that section. The Authorization,
which includes an explanation of the reasons for issuance, is reprinted
in this document.

DATES: The Authorization is effective as of February 11, 2022.

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

FOR FURTHER INFORMATION CONTACT: Michael Mair, Office of
Counterterrorism and Emerging Threats, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 1, Rm. 4340, Silver Spring, MD 20993-
0002,<PHONE_NUMBER> (this is not a toll free number).

SUPPLEMENTARY INFORMATION:

I. Background

    Section 564 of the FD&C Act (21 U.S.C. 360bbb-3) allows FDA to
strengthen public health protections against biological, chemical,
nuclear, and radiological agents. Among other things, section 564 of
the FD&C Act allows FDA to authorize the use of an unapproved medical
product or an unapproved use of an approved medical product in certain
situations. With this EUA authority, FDA can help ensure that medical
countermeasures may be used in emergencies to diagnose, treat, or
prevent serious or life-threatening diseases or conditions caused by
biological, chemical, nuclear, or radiological agents when there are no
adequate, approved, and available alternatives (among other criteria).

II. Criteria for EUA Authorization

    Section 564(b)(1) of the FD&C Act provides that, before an EUA may
be issued, the Secretary of HHS must declare that circumstances exist
justifying the authorization based on one of the following grounds: (1)
A determination by the Secretary of Homeland Security that there is a
domestic emergency, or a significant potential for a domestic
emergency, involving a heightened risk of attack with a biological,
chemical, radiological, or nuclear agent or agents; (2) a determination
by the Secretary of Defense that there is a military emergency, or a
significant potential for a military emergency, involving a heightened
risk to U.S. military forces, including personnel operating under the
authority of title 10 or title 50, U.S. Code, of attack with (A) a
biological, chemical, radiological, or nuclear agent or agents; or (B)
an agent or agents that may cause, or are otherwise associated with, an
imminently life-threatening and specific risk to U.S. military forces;
\1\ (3) a determination by the Secretary of HHS that there is a public
health emergency, or a significant potential for a public health
emergency, that affects, or has a significant potential to affect,
national security or the health and security of U.S. citizens living
abroad, and that involves a biological, chemical, radiological, or
nuclear agent or agents, or a disease or condition that may be
attributable to such agent or agents; or (4) the identification of a
material threat by the Secretary of Homeland Security pursuant to
section 319F-2 of the Public Health Service (PHS) Act (42 U.S.C. 247d-
6b) sufficient to affect national security or the health and security
of U.S. citizens living abroad.
---------------------------------------------------------------------------

    \1\ In the case of a determination by the Secretary of Defense,
the Secretary of HHS shall determine within 45 calendar days of such
determination, whether to make a declaration under section 564(b)(1)
of the FD&C Act, and, if appropriate, shall promptly make such a
declaration.
---------------------------------------------------------------------------

    Once the Secretary of HHS has declared that circumstances exist
justifying an authorization under section 564 of the FD&C Act, FDA may
authorize the emergency use of a drug, device, or biological product if
the Agency concludes that the statutory criteria are satisfied. Under
section 564(h)(1) of the FD&C Act, FDA is required to publish in the
Federal Register a notice of each authorization, and each termination
or revocation of an authorization, and an explanation of the reasons
for the action. Under section 564(h)(1) of the FD&C Act, revisions to
an authorization shall be made available on the internet website of
FDA. Section 564 of the FD&C Act permits FDA to authorize the
introduction into interstate commerce of a drug, device, or biological
product intended for use in an actual or potential emergency when the
Secretary of HHS has declared that circumstances exist justifying the
authorization of emergency use. Products appropriate for emergency use
may include products and uses that are not approved, cleared, or
licensed under sections 505, 510(k), 512, or 515 of the FD&C Act (21
U.S.C. 355, 360(k), 360b, and 360e) or section 351 of the PHS Act (42
U.S.C. 262), or conditionally approved under section 571 of the FD&C
Act (21 U.S.C. 360ccc). FDA may issue an EUA only if, after
consultation with the HHS Assistant Secretary for Preparedness and
Response, the Director of the National Institutes of Health, and the
Director of the Centers for Disease Control and Prevention (to the
extent feasible and appropriate given the applicable circumstances),

FDA \2\ concludes: (1) That an agent referred to in a declaration of
emergency or threat can cause a serious or life-threatening disease or
condition; (2) that, based on the totality of scientific evidence
available to FDA, including data from adequate and well-controlled
clinical trials, if available, it is reasonable to believe that: (A)
The product may be effective in diagnosing, treating, or preventing (i)
such disease or condition; or (ii) a serious or life-threatening
disease or condition caused by a product authorized under section 564,
approved or cleared under the FD&C Act, or licensed under section 351
of the PHS Act, for diagnosing, treating, or preventing such a disease
or condition caused by such an agent; and (B) the known and potential
benefits of the product, when used to diagnose, prevent, or treat such
disease or condition, outweigh the known and potential risks of the
product, taking into consideration the material threat posed by the
agent or agents identified in a declaration under section 564(b)(1)(D)
of the FD&C Act, if applicable; (3) that there is no adequate,
approved, and available alternative to the product for diagnosing,
preventing, or treating such disease or condition; (4) in the case of a
determination described in section 564(b)(1)(B)(ii) of the FD&C Act,
that the request for emergency use is made by the Secretary of Defense;
and (5) that such other criteria as may be prescribed by regulation are
satisfied.
---------------------------------------------------------------------------

    \2\ The Secretary of HHS has delegated the authority to issue an
EUA under section 564 of the FD&C Act to the Commissioner of Food
and Drugs.
---------------------------------------------------------------------------

    No other criteria for issuance have been prescribed by regulation
under section 564(c)(4) of the FD&C Act.

III. The Authorization

    The Authorization follows the February 4, 2020, determination by
the Secretary of HHS that there is a public health emergency that has a
significant potential to affect national security or the health and
security of U.S. citizens living abroad and that involves a novel (new)
coronavirus. The virus, now named SARS-CoV-2, causes the illness COVID-
19. Notice of the Secretary's determination was provided in the Federal
Register on February 7, 2020 (85 FR 7316). On the basis of such
determination, the Secretary of HHS declared on March 27, 2020, that
circumstances exist justifying the authorization of emergency use of
drugs and biological products during the COVID-19 pandemic, pursuant to
section 564 of the FD&C Act, subject to the terms of any authorization
issued under that section. Notice of the Secretary's declaration was
provided in the Federal Register on April 1, 2020 (85 FR 18250). Having
concluded that the criteria for issuance of the Authorization under
section 564(c) of the FD&C Act are met, FDA has issued the
authorization for the emergency use of a biological product during the
COVID-19 pandemic. On February 11, 2022, FDA issued an EUA to Lilly for
the biological product bebtelovimab, subject to the terms of the
Authorization. The initial Authorization, which is included below in
its entirety after section IV of this document (not including the
authorized versions of the fact sheets and other written materials),
provides an explanation of the reasons for issuance, as required by
section 564(h)(1) of the FD&C Act. Any subsequent reissuance of the
Authorization can be found on FDA's web page at: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization.

IV. Electronic Access

    An electronic version of this document and the full text of the
Authorization is available on the internet at: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization.
BILLING CODE 4164-01-P

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    Dated: March 14, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-06009 Filed 3-21-22; 8:45 am]
BILLING CODE 4164-01-C


[Federal Register Volume 78, Number 92 (Monday, May 13, 2013)]
[Proposed Rules]
[Pages 27869-27872]
[FR Doc No: 2013-11240]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2013-0400; Directorate Identifier 2009-SW-48-AD]
RIN 2120-AA64

Airworthiness Directives; Bell Helicopter Textron Canada Limited
(Bell) Model Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for
Bell

Model 206A, 206B, 206L, 206L-1, 206L-3, 206L-4, 222, 222B, 222U, 230,
407, 427, and 430 helicopters. This proposed AD would require
inspecting each bearing to determine if it has been properly staked and
replacing the bearing or assembly if it has not been staked properly.
This proposed AD is prompted by bearings not being staked as required
and migrating out of their proper position, which may limit the
functionality of the affected part. The proposed actions are intended
to prevent failure of a bearing and the assembly in which it is
installed and subsequent loss of control of the helicopter.

DATES: We must receive comments on this proposed AD by July 12, 2013.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Docket: Go to http://www.regulations.gov. Follow the online instructions for sending your
comments electronically.
     Fax:<PHONE_NUMBER>.
     Mail: Send comments to the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590-0001.
     Hand Delivery: Deliver to the ``Mail'' address between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov or in person at the Docket Operations Office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this proposed AD, the economic
evaluation, any comments received, and other information. The street
address for the Docket Operations Office (telephone<PHONE_NUMBER>) is in
the ADDRESSES section. Comments will be available in the AD docket
shortly after receipt.
    For service information identified in this proposed AD, contact
Bell Helicopter Textron Canada Limited, 12,800 Rue de l'Avenir,
Mirabel, Quebec J7J1R4, telephone<PHONE_NUMBER> or<PHONE_NUMBER>, fax
(450) 433-0272, or at http://www.bellcustomer.com/files/. You may
review the referenced service information at the FAA, Office of the
Regional Counsel, Southwest Region, 2601 Meacham Blvd., Room 663, Fort
Worth, Texas 76137.

FOR FURTHER INFORMATION CONTACT: Sharon Miles, Aviation Safety
Engineer, Regulations and Policy Group, Rotorcraft Directorate, FAA,
2601 Meacham Blvd., Fort Worth, Texas 76137; telephone<PHONE_NUMBER>;
email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to participate in this rulemaking by submitting
written comments, data, or views. We also invite comments relating to
the economic, environmental, energy, or federalism impacts that might
result from adopting the proposals in this document. The most helpful
comments reference a specific portion of the proposal, explain the
reason for any recommended change, and include supporting data. To
ensure the docket does not contain duplicate comments, commenters
should send only one copy of written comments, or if comments are filed
electronically, commenters should submit only one time.
    We will file in the docket all comments that we receive, as well as
a report summarizing each substantive public contact with FAA personnel
concerning this proposed rulemaking. Before acting on this proposal, we
will consider all comments we receive on or before the closing date for
comments. We will consider comments filed after the comment period has
closed if it is possible to do so without incurring expense or delay.
We may change this proposal in light of the comments we receive.

Discussion

    Transport Canada, which is the aviation authority for Canada, has
issued Canadian AD No. CF-2009-32, dated July 24, 2009, to correct an
unsafe condition for the specified Bell model helicopters. Transport
Canada advises that some bearings may not have been staked as required,
which may limit the proper functioning of the affected part. Bell, the
helicopter manufacturer, received two reports stating that a bearing
migrated out of a flight control lever. Investigation revealed that,
although the inspection witness mark was applied to the part, the
bearing had not been staked during manufacturing. Affected parts were
associated with a single Bell supplier. Review of the supplier's
manufacturing and quality process indicates inspection of additional
parts is necessary.

FAA's Determination

    These helicopters have been approved by the aviation authority of
Canada and are approved for operation in the United States. Pursuant to
our bilateral agreement with Canada, Transport Canada has notified us
of the unsafe condition described in its AD. We are proposing this AD
because we evaluated all known relevant information and determined that
an unsafe condition is likely to exist or develop on other helicopters
of these same type designs.

Related Service Information

    Bell has issued Alert Service Bulletin (ASB) No. 206-09-122 for
Model 206A/B series; No. 206L-09-156 for Model 206L series; No. 222-09-
107 for Model 222 and 222B; No. 222U-09-78 for Model 222U; No. 230-09-
39 for Model 230; No. 407-09-88 for Model 407; No. 427-09-25 for Model
427; and No. 430-09-42, for Model 430, all dated April 7, 2009. The
ASBs specify inspecting for parts that contain bearings that have not
been staked.

Proposed AD Requirements

    This proposed AD would require using a 10X or higher power
magnifying glass or a boroscope to inspect each bearing in each
affected part to determine if each bearing has been properly staked.
This proposed AD would only require parts that contain a serial number
with a prefix of ``TI'' or ``TIFS,'' or parts without a serial number
even if the part has a supplier marking with a circle around a ``T.M.''
over a ``1,'' to be inspected. If you cannot access the part to
determine if the bearing is properly staked, this proposed AD would
require removing the part from the helicopter to inspect it.

Costs of Compliance

    We estimate that this proposed AD would affect about 2,601
helicopters of U.S. registry. Based on an average labor rate of $85 per
work-hour, we estimate that operators may incur the following costs in
order to comply with this AD. It would take about 1 to 5 work-hours per
helicopter, depending on the model, to inspect for properly staked
bearings. Replacing a bearing would require about 2 work-hours and
would cost $3,306 for required parts. Based on an average inspection
time of 2 work-hours, we estimate the cost of this proposed AD to
inspect the helicopters would be $170 per helicopter and $442,170 for
the U.S. operator fleet. Replacing a bearing would cost $3,476 per
helicopter.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.

    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on product(s) identified in this
rulemaking action.

Authority for This Rulemaking

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

Regulatory Findings

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

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

Bell Helicopter Textron Canada Limited: Docket No. FAA-2013-0400;
Directorate Identifier 2009-SW-48-AD.

(a) Applicability

    This AD applies to Model 206A, 206B, 206L, 206L-1, 206L-3, 206L-
4, 222, 222B, 222U, 230, 407, 427, and 430 helicopters as follows,
certificated in any category.
    (1) Model 206A, Model 206B helicopters converted from Model
206A, and Model 206B with Bellcrank Assembly, part-number (P/N) 206-
001-526-001 or 206-001-538-009; Idler Link Assembly, P/N 206-010-
336-109; or Link Assembly, P/N 206-031-589-001, installed.
    (2) Model 206L, Model 206L-1, Model 206L-3, and Model 206L-4
with Idler Assembly, P/N 206-001-549-101; Bellcrank Assembly, P/N
206-001-552-001; or Link Assembly, P/N 206-010-336-109, installed.
    (3) Model 222 and Model 222B with
    (i) Cyclic Link Assembly, P/N 222-010-419-110; or
    (ii) Bellcrank Assembly Directional Controls, P/N 222-001-734-
001 or 222-001-736-005, installed.
    (4) Model 222U with
    (i) Cyclic Link Assembly, P/N 222-010-419-110; or
    (ii) Bellcrank Assembly Directional Controls, P/N 222-001-734-
001 or 222-001-736-005, installed.
    (5) Model 230 with
    (i) Fitting Assembly Engine Bipod Mount, P/N 230-060-113-101,
230-060-113-102, 230-060-114-101, or 230-060-114-102; Cyclic Link
Assembly P/N 222-010-419-110; or
    (ii) Bellcrank Assembly Directional Controls, P/N 222-001-734-
001, or 222-001-736-005, installed.
    (6) Model 407 with
    (i) Bearing and Liner Assembly, P/N 406-010-417-101; Cyclic
Mixer Follower Assembly, P/N 407-001-325-101; Bellcrank Assembly, P/
N 407-001-524-105, 407-001-524-109, 407-001-526-105, 407-001-526-
109, 407-001-528-101, or 407-001-528-105; or
    (ii) Beam Assembly, P/N 407-001-723-101, installed.
    (7) Model 427 with Swashplate Lateral Link Assembly (upper and
lower bearing), P/N 427-001-021-101; Swashplate Longitudinal Link
Assembly (upper and lower bearing), P/N 427-001-022-101;
Transmission Mounted Longitudinal Bellcrank Assembly (pivot
bearing), P/N 427-001-521-105/-109; Transmission Mounted Lateral
Bellcrank Assembly (pivot bearing), P/N 427-001-520-109/-113; or
Bearing and Liner (lower drive link bearing), P/N 406-010-417-109,
installed.
    (8) Model 427 with Tail Rotor Actuator Output Idler, P/N 427-
001-723-101, installed.
    (9) Model 430 with
    (i) Fitting Assembly Engine Bipod Mount, P/N 230-060-113-101,
230-060-113-102, 230-060-114-101, or 230-060-114-102; Bearing
Assembly M/R Rotating Controls, P/N 430-010-449-101; Rod End
Assembly Lift link, P/N 430-010-204-101 or 430-010-204-103, or
    (ii) Bellcrank Assembly Directional Controls, P/N 222-001-734-
001, or 222-001-736-005, installed.

(b) Unsafe Condition

    This AD defines the unsafe condition as bearings that may not
have been staked as required and may migrate out of their proper
position and limit the functionality of the affected part. This
condition could result in failure of a bearing and the lever
assembly in which it is installed and subsequent loss of control of
the helicopter.

(c) Comments Due Date

    We must receive comments by July 12, 2013.

(d) Compliance

    You are responsible for performing each action required by this
AD within the specified compliance time unless it has already been
accomplished prior to that time.

(e) Required Actions

    (1) Perform each action required by this AD within the
compliance time for each part listed in the applicability paragraph
of this AD as follows: (a)(1), (a)(2), (a)(6)(i), (a)(7), and
(a)(8), within 10 hours time-in-service (TIS) or 30 days, whichever
occurs first; (a)(3)(i), (a)(4)(i), (a)(5)(i), and (a)(9)(i), within
5 hours TIS or 30 days, whichever occurs first; (a)(3)(ii),
(a)(4)(ii), (a)(5)(ii), and (a)(9)(ii) within 150 hours TIS or 12
months, whichever occurs first; and (a)(6)(ii) within 300 hours TIS
or 12 months, whichever occurs first.
    (2) Using a 10X or higher power magnifying glass or using a
boroscope, inspect each bearing and determine if the bearing has
been properly staked for each part that contains a part serial
number with a prefix of either ``TI'' or ``TIFS.''
    (i) If a part does not contain a serial number, inspect the
bearing of that part even if that part contains a supplier marking.
    (ii) If you cannot access the bearing while the part is
installed on the helicopter to make a determination as to whether
the bearing in

the part is properly staked, remove the part and inspect the bearing
using a 10X or higher power magnifying glass or using a boroscope.
    (iii) If you find a part that is not properly staked, replace
the bearing or the assembly with an airworthy bearing or assembly
before further flight.

 (f) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Safety Management Group, FAA, may approve AMOCs
for this AD. Send your proposal to Sharon Miles, ASW-111, Aviation
Safety Engineer, Rotorcraft Directorate, Regulations and Guidance
Group, 2601 Meacham Blvd., Fort Worth, Texas 76137, telephone (817)
222-5110, email<EMAIL_ADDRESS>    (2) For operations conducted under a 14 CFR part 119 operating
certificate or under 14 CFR part 91, subpart K, we suggest that you
notify your principal inspector, or lacking a principal inspector,
the manager of the local flight standards district office or
certificate holding district office before operating any aircraft
complying with this AD through an AMOC.

(g) Additional Information

    (1) Bell Alert Service Bulletin (ASB) No. 206-09-122 for Models
206A and 206B; No. 206L-09-156 for Models 206L, 206L-1, 206L-3, and
206L-4; No. 222-09-107 for Models 222 and 222B; No. 222U-09-78 for
Model 222U; No. 230-09-39 for Model 230; No. 407-09-88 for Model
407; No. 427-09-25 for Model 427; and No. 430-09-42 for Model 430,
all dated April 7, 2009, which are not incorporated by reference,
contain additional information about the subject of this AD. For
service information identified in this proposed AD, contact Bell
Helicopter Textron Canada Limited, 12,800 Rue de l'Avenir, Mirabel,
Quebec J7J1R4, telephone<PHONE_NUMBER> or<PHONE_NUMBER>, fax (450)
433-0272, or at http://www.bellcustomer.com/files/. You may review
the referenced service information at the FAA, Office of the
Regional Counsel, Southwest Region, 2601 Meacham Blvd., Room 663,
Fort Worth, Texas 76137.
    (2) The subject of this AD is addressed in Transport Canada AD
No. CF-2009-32, dated July 24, 2009.

(h) Subject

    Joint Aircraft System/Component (JASC) Code: 6700 Rotorcraft
Flight Controls and 6710 Main Rotor Control.

    Issued in Fort Worth, Texas, on April 26, 2013.
Kim Smith,
Directorate Manager, Rotorcraft Directorate, Aircraft Certification
Service.
[FR Doc. 2013-11240 Filed 5-10-13; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: February 23, 2007 (Volume 72, Number 36)]
[Notices]
[Page 8209-8215]
[DOCID:fr23fe07-97]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. IC-27701; File No. 812-13272]

Wilshire Variable Insurance Trust, et al.; Notice of Application

February 16, 2007.
AGENCY: Securities and Exchange Commission (``SEC'' or ``Commission'').

ACTION: Notice of application for an exemption pursuant to Section 6(c)
of the Investment Company Act of 1940, as amended (the ``1940 Act'')
from the provisions of Sections 9(a), 13(a), 15(a) and 15(b) of the Act
and Rules 6e-2(b)(15) and 6e-3(T)(b)(15) thereunder.

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APPLICANTS:  Wilshire Variable Insurance Trust (the ``Trust'') and
Wilshire Associates Incorporated (``Wilshire'' and together with the
Trust, ``Applicants'').

SUMMARY OF APPLICATION:  Applicants seek an order exempting them from
the provisions of Sections 9(a), 13(a), 15(a) and 15(b) of the 1940
Act, and Rules 6e-2(b)(15) and 6e-3(T)(b)(15) thereunder, to the extent
necessary to permit shares of the Trust and shares of any other
investment company or portfolio that is designed to fund insurance
products and for which Wilshire or any of its affiliates may serve in
the future as investment adviser, manager, principal underwriter,
sponsor, or administrator (``Future Trusts'') (the Trust, together with
Future Trusts, the ``Trusts'') to be sold to and held by: (a) Separate
accounts funding variable annuity and variable life insurance contracts
(collectively the ``Variable Contracts'') issued by both affiliated and
unaffiliated life insurance companies; (b) trustees of qualified group
pension and group retirement plans (``Qualified Plans'') outside of the
separate account context; (c) separate accounts that are not registered
as investment companies under the 1940 Act pursuant to exemptions from
registration under Section 3(c) of the 1940 Act; (d) Wilshire and any
affiliate of Wilshire that serves as an investment adviser, manager,
principal underwriter, sponsor or administrator for the purpose of
providing seed capital (collectively, ``Wilshire Entities''); (e) any
other insurance company general accounts permitted to hold shares of
the Trusts pursuant to Treasury Regulation Section 1.817-5 (``General
Accounts'').

FILING DATE:  The application was filed on April 4, 2006 and amended on
November 1, 2006.

HEARING OR NOTIFICATION OF HEARING:  An order granting the application
will be issued unless the Commission orders

a hearing. Interested persons may request a hearing by writing to the
Secretary of the Commission 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 March 14, 2007, and should be
accompanied by proof of service on Applicants in the form of an
affidavit or, for lawyers, a certificate of service. Hearing requests
should State the nature of the requester's interest, 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 Secretary of the
Commission.

ADDRESSES:  Secretary, SEC, 100 F Street, NE., Washington, DC 20549-
1090. Applicants, Lawrence E. Davanzo, c/o Wilshire Associates
Incorporated, 1299 Ocean Avenue, Suite 700, Santa Monica, California
90401.

FOR FURTHER INFORMATION CONTACT:  Sally Samuel, Senior Counsel, or
Joyce M. Pickholz, Branch Chief, Office of Insurance Products, Division
of Investment Management, at<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:  The following is a summary of the
application. The complete application may be obtained for a fee from
the SEC's Public Reference Branch, 100 F Street, NE., Washington, DC
20549 (tel.<PHONE_NUMBER>).

Applicants' Representations

    1. The Trust is registered with the Commission as an open-end
management investment company and is organized as a Delaware statutory
trust. Wilshire, a California corporation, is registered with the
Commission as an investment adviser under the Investment Advisers Act
of 1940, as amended, and serves as the investment adviser to the Trust.
The Trust currently consists of, and offers shares of beneficial
interest (``shares'') representing interests in, fourteen separate
investment portfolios (each, a ``Portfolio,'' and collectively, the
``Portfolios''). The Trust or any Future Trusts may offer one or more
additional investment portfolios in the future (also referred to as
``Portfolios'').
    2. Shares of the Portfolios will be offered to separate accounts of
affiliated and unaffiliated insurance companies (each, a
``Participating Insurance Company'') as investment vehicles to fund
Variable Contracts. These separate accounts will be registered as
investment companies under the 1940 Act or will be exempt from such
registration (individually, a ``Separate Account'' and collectively,
the ``Separate Accounts''). Shares of the Portfolios may also be
offered to Qualified Plans, Wilshire Entities and General Accounts.
    3. The Participating Insurance Companies at the time of their
investment in the Trusts either have established or will establish
their own Separate Accounts and have designed or will design their own
Variable Contracts. Each Participating Insurance Company has or will
have the legal obligation of satisfying all applicable requirements
under both State and Federal law. Each Participating Insurance Company,
on behalf of its Separate Accounts, has entered or will enter into an
agreement with the Trusts concerning such Participating Insurance
Company's participation in the Portfolios. The role of the Trusts under
this agreement, insofar as the Federal securities laws are applicable,
will consist of, among other things, offering shares of the Portfolios
to the participating Separate Accounts and complying with any
conditions that the Commission may impose upon granting the order
requested herein.

Applicants' Legal Analysis

    1. In connection with the funding of scheduled premium variable
life insurance contracts issued through a separate account registered
as a unit investment trust (``UIT'') under the 1940 Act, Rule 6e-
2(b)(15) provides partial exemptions from Sections 9(a), 13(a), 15(a)
and 15(b) of the 1940 Act. Section 9(a)(2) of the 1940 Act makes it
unlawful for any company to serve as an investment adviser or principal
underwriter of any UIT, if an affiliated person of that company is
subject to a disqualification enumerated in Sections 9(a)(1) or (2) of
the 1940 Act. Sections 13(a), 15(a) and 15(b) of the 1940 Act have been
deemed by the Commission to require ``pass-through'' voting with
respect to an underlying investment company's shares. Rule 6e-2(b)(15)
provides that these exemptions apply only where all of the assets of
the UIT are shares of management investment companies ``which offer
their shares exclusively to variable life insurance separate accounts
of the life insurer or of any affiliated life insurance company.''
Therefore, the relief granted by Rule 6e-2(b)(15) is not available with
respect to a scheduled premium life insurance separate account that
owns shares of an underlying fund that also offers its shares to a
variable annuity separate account or flexible premium variable life
insurance separate account of the same company or any other affiliated
insurance company. The use of a common management investment company as
the underlying investment vehicle for both variable annuity and
variable life insurance separate accounts of the same life insurance
company or of any affiliated life insurance company is referred to
herein as ``mixed funding.''
    2. The relief granted by Rule 6e-2(b)(15) also is not available
with respect to a scheduled premium variable life insurance separate
account that owns shares of an underlying fund that also offers its
shares to separate accounts funding Variable Contracts of one or more
unaffiliated life insurance companies. The use of a common management
investment company as the underlying investment vehicle for variable
annuity and/or variable life insurance separate accounts of
unaffiliated life insurance companies is referred to herein as ``shared
funding.''
    3. The relief under Rule 6e-2(b)(15) is available only where shares
are offered exclusively to variable life insurance separate accounts of
a life insurer or any affiliated life insurance company, additional
exemptive relief is necessary if the shares of the Portfolios are also
to be sold to Qualified Plans or other eligible holders of shares, as
described above. Applicants note that if shares of the Portfolios are
sold only to Qualified Plans, exemptive relief under Rule 6e-2 would
not be necessary. The relief provided for under this section does not
relate to Qualified Plans or to a registered investment company's
ability to sell its shares to Qualified Plans. The use of a common
management investment company as the underlying investment vehicle for
variable annuity and variable life separate accounts of affiliated and
unaffiliated insurance companies, and for Qualified Plans, is referred
to herein as ``extended mixed and shared funding.''
    4. In connection with flexible premium variable life insurance
contracts issued through a separate account registered under the 1940
Act as a UIT, Rule 6e-3(T)(b)(15) provides partial exemptions from
Sections 9(a), 13(a), 15(a) and 15(b) of the 1940 Act. The exemptions
granted by Rule 6e-3(T)(b)(15) are available only where all the assets
of the separate account consist of the shares of one or more registered
management investment companies that offer to sell their shares
``exclusively to separate accounts of the life insurer, or of any
affiliated life insurance companies, offering either scheduled
contracts or flexible contracts, or both; or which also offer their
shares to variable annuity separate accounts of the life insurer or of
an affiliated life insurance company or

which offer their shares to any such life insurance company in
consideration solely for advances made by the life insurer in
connection with the operation of the separate account.'' Therefore,
Rule 6e-3(T)(b)(15) permits mixed funding but does not permit shared
funding.
    5. The relief under Rule 6e-3(T) is available only where shares are
offered exclusively to variable life insurance separate accounts of a
life insurer or any affiliated life insurance company, and additional
exemptive relief is necessary if the shares of the Portfolios are also
to be sold to Qualified Plans or other eligible holders of shares as
described above. Applicants note that if shares of the Portfolios were
sold only to Qualified Plans, exemptive relief under Rule 6e-
3(T)(b)(15) would not be necessary. The relief provided for under this
section does not relate to Qualified Plans or to a registered
investment company's ability to sell its shares to Qualified Plans.
    6. Applicants maintain, as discussed below, that there is no policy
reason for the sale of the Portfolios' shares to Qualified Plans, to
Wilshire Entities, or General Accounts to result in a prohibition
against, or otherwise limit, a Participating Insurance Company from
relying on the relief provided by Rules 6e-2(b)(15) and 6e-3(T)(b)(15).
However, because the relief under Rules 6e-2(b)(15) and 6e-3(T)(b)(15)
is available only when shares are offered exclusively to separate
accounts, additional exemptive relief may be necessary if the shares of
the Portfolios are also to be sold to Qualified Plans, Wilshire
Entities, or General Accounts. Applicants therefore request relief in
order to have the Participating Insurance Companies enjoy the benefits
of the relief granted in Rules 6e-2(b)(15) and 6e-3(T)(b)(15).
Applicants note that if the Portfolios' shares were to be sold only to
Qualified Plans, Wilshire Entities, or General Accounts and/or separate
accounts funding variable annuity contracts, exemptive relief under
Rule 6e-2 and Rule 6e-3(T) would be unnecessary. The relief provided
for under Rules 6e-2(b)(15) and 6e-3(T)(b)(15) does not relate to
Qualified Plans, Wilshire Entities, or General Accounts, or to a
registered investment company's ability to sell its shares to such
purchasers.
    7. Section 9(a)(3) of the 1940 Act provides that it is unlawful for
any company to serve as investment adviser or principal underwriter of
any registered open-end investment company if an affiliated person of
that company is subject to a disqualification enumerated in Sections
9(a)(1) or (2). Rules 6e-2(b)(15)(i) and (ii) and Rules 6e-
3(T)(b)(15)(i) and (ii) under the 1940 Act provide exemptions from
Section 9(a) under certain circumstances, subject to the limitations
discussed above on mixed and shared funding. These exemptions limit the
application of the eligibility restrictions to affiliated individuals
or companies that directly participate in management of the underlying
management company.
    8. The partial relief granted in Rules 6e-2(b)(15) and 6e-
3(T)(b)(15) under the 1940 Act from the requirements of Section 9 of
the 1940 Act recognizes that it is not necessary for the protection of
investors or the purposes fairly intended by the policy and provisions
of the 1940 Act to apply the provisions of Section 9(a) to individuals
in a large insurance company complex, most of whom will have no
involvement in matters pertaining to investment companies in that
organization. The Participating Insurance Companies and Qualified Plans
are not expected to play any role in the management of the Trusts.
Those individuals who participate in the management of the Trusts will
remain the same regardless of which Separate Accounts or Qualified
Plans invest in the Trusts. Applying the monitoring requirements of
Section 9(a) of the 1940 Act because of investment by separate accounts
of other insurers or Qualified Plans would be unjustified and would not
serve any regulatory purpose.
    9. Rules 6e-2(b)(15)(iii) and 6e-3(T)(b)(15)(iii) under the 1940
Act provide exemptions from the pass-through voting requirement with
respect to several significant matters, assuming the limitations on
mixed and shared funding are observed. Rules 6e-2(b)(15)(iii)(A) and
6e-3(T)(b)(15)(iii)(A)(1) provide that the insurance company may
disregard the voting instructions of its contract owners with respect
to the investments of an underlying fund, or any contract between such
a fund and its investment adviser, when required to do so by an
insurance regulatory authority (subject to the provisions of paragraphs
(b)(5)(i) and (b)(7)(ii)(A) of Rules 6e-2 and 6e-3(T), respectively,
under the 1940 Act). Rules 6e-2(b)(15)(iii)(B) and 6e-
3(T)(b)(15)(iii)(A)(2) provide that the insurance company may disregard
the voting instructions of its contract owners if the contract owners
initiate any change in an underlying fund's investment policies,
principal underwriter, or any investment adviser (provided that
disregarding such voting instructions is reasonable and subject to the
other provisions of paragraphs (b)(5)(ii), (b)(7)(ii)(B), and
(b)(7)(ii)(C), respectively, of Rules 6e-2 and 6e-3(T) under the 1940
Act).
    10. Rule 6e-2 under the 1940 Act recognizes that a variable life
insurance contract, as an insurance contract, has important elements
unique to insurance contracts and is subject to extensive State
regulation of insurance. In adopting Rule 6e-2(b)(15)(iii), the
Commission expressly recognized that State insurance regulators have
authority, pursuant to State insurance laws or regulations, to
disapprove or require changes in investment policies, investment
advisers, or principal underwriters. The Commission also expressly
recognized that State insurance regulators have authority to require an
insurer to draw from its general account to cover costs imposed upon
the insurer by a change approved by contract owners over the insurer's
objection. The Commission, therefore, deemed such exemptions necessary
to assure the life insurer's solvency and performance of its
contractual obligations by enabling an insurance regulatory authority
or the life insurer to act when certain proposals reasonably could be
expected to increase the risks undertaken by the life insurer. In this
respect, flexible premium variable life insurance contracts are
identical to scheduled premium variable life insurance contracts.
Therefore, the corresponding provisions of Rule 6e-3(T) under the 1940
Act undoubtedly were adopted in recognition of the same factors.
    11. The sale of Portfolio shares to Qualified Plans, Wilshire
Entities, and General Accounts will not have any impact on the relief
requested herein. With respect to the Qualified Plans, which are not
registered as investment companies under the 1940 Act, there is no
requirement to pass through voting rights to Qualified Plan
participants. Indeed, to the contrary, applicable law expressly
reserves voting rights associated with Qualified Plan assets to certain
specified persons. Under Section 403(a) of the Employee Retirement
Income Security Act of 1974, as amended (``ERISA''), shares of a
portfolio of a fund sold to a Qualified Plan must be held by the
trustees of the Qualified Plan. Section 403(a) also provides that the
trustee(s) must have exclusive authority and discretion to manage and
control the Qualified Plan with two exceptions: (i) When the Qualified
Plan expressly provides that the trustee(s) are subject to the
direction of a named fiduciary who is not a trustee, in which case the
trustees are subject to proper directions made in accordance with the
terms of the Qualified Plan and not contrary to

ERISA, and (ii) when the authority to manage, acquire, or dispose of
assets of the Qualified Plan is delegated to one or more investment
managers pursuant to Section 402(c)(3) of ERISA. Unless one of the
above two exceptions stated in Section 403(a) applies, Qualified Plan
trustees have the exclusive authority and responsibility for voting
proxies.
    12. Where a named fiduciary to a Qualified Plan appoints an
investment manager, the investment manager has the responsibility to
vote the shares held unless the right to vote such shares is reserved
to the trustees or the named fiduciary. The Qualified Plans may have
their trustee(s) or other fiduciaries exercise voting rights
attributable to investment securities held by the Qualified Plans in
their discretion. Some of the Qualified Plans, however, may provide for
the trustee(s), an investment adviser (or advisers), or another named
fiduciary to exercise voting rights in accordance with instructions
from participants. Similarly, Wilshire Entities and General Accounts
are not subject to any pass-through voting requirements. Accordingly,
unlike the case with insurance company separate accounts, the issue of
resolution of material irreconcilable conflicts with respect to voting
is not present with Qualified Plans, Wilshire Entities, or General
Accounts.
    13. Where a Qualified Plan does not provide participants with the
right to give voting instructions, the trustee or named fiduciary has
responsibility to vote the shares held by the Qualified Plan. In this
circumstance, the trustee has a fiduciary duty to vote the shares in
the best interest of the Qualified Plan participants. Accordingly, even
if Wilshire or an affiliate of Wilshire were to serve in the capacity
of trustee or named fiduciary with voting responsibilities, Wilshire or
its affiliate would have a fiduciary duty to vote those shares in the
best interest of the Qualified Plan participants.
    14. In addition, even if a Qualified Plan were to hold a
controlling interest in a Portfolio, Applicants do not believe that
such control would disadvantage other investors in such Portfolio to
any greater extent than is the case when any institutional shareholder
holds a majority of the voting securities of any open-end management
investment company. In this regard, Applicants submit that investment
in a Portfolio by a Qualified Plan will not create any of the voting
complications occasioned by mixed funding or shared funding. Unlike
mixed funding or shared funding, Qualified Plan investor voting rights
cannot be frustrated by veto rights of insurers or State regulators.
    15. Where a Qualified Plan provides participants with the right to
give voting instructions, Applicants see no reason to believe that
participants in Qualified Plans generally or those in a particular
Qualified Plan, either as a single group or in combination with
participants in other Qualified Plans, would vote in a manner that
would disadvantage Variable Contract holders. The purchase of shares of
Portfolios by Qualified Plans that provide voting rights does not
present any complications not otherwise occasioned by mixed or shared
funding.
    16. Shared funding by unaffiliated insurance companies does not
present any issues that do not already exist where a single insurance
company is licensed to do business in several or all States. A
particular State insurance regulatory body could require action that is
inconsistent with the requirements of other States in which the
insurance company offers its policies. The fact that different insurers
may be domiciled in different States does not create a significantly
different or enlarged problem.
    17. Shared funding by unaffiliated insurers, in this respect, is no
different than the use of the same investment company as the funding
vehicle for affiliated insurers, which Rules 6e-2(b)(15) and 6e-
3(T)(b)(15) under the 1940 Act permit. Affiliated insurers may be
domiciled in different States and be subject to differing State law
requirements. Affiliation does not reduce the potential, if any exists,
for differences in State regulatory requirements. In any event, the
conditions set forth below are designed to safeguard against, and
provide procedures for resolving, any adverse effects that differences
among State regulatory requirements may produce. If a particular State
insurance regulator's decision conflicts with the majority of other
State regulators, then the affected insurer will be required to
withdraw its Separate Account's investment in the affected Trust. This
requirement will be provided for in agreements that will be entered
into by Participating Insurance Companies with respect to their
participation in the relevant Portfolio.
    18. Rules 6e-2(b)(15) and 6e-3(T)(b)(15) under the 1940 Act give
the insurance company the right to disregard the voting instructions of
the contract owners in certain circumstances. Affiliation does not
eliminate the potential, if any exists, for divergent judgments as to
the advisability or legality of a change in investment policies,
principal underwriter, or investment adviser initiated by contract
owners. The potential for disagreement is limited by the requirements
in Rules 6e-2 and 6e-3(T) under the 1940 Act that the insurance
company's disregard of voting instructions be reasonable and based on
specific good-faith determinations.
    19. A Participating Insurance Company's disregard of voting
instructions, nevertheless, could conflict with the majority of
contract owners' voting instructions. The Participating Insurance
Company's action possibly could be different than the determination of
all or some of the other insurers (including affiliated insurers) that
the voting instructions of contract owners should prevail, and either
could preclude a majority vote approving the change or could represent
a minority view. If the Participating Insurance Company's judgment
represents a minority position or would preclude a majority vote, then
the Participating Insurance Company's may be required, at the affected
Trust's election, to withdraw its Separate Account's investment in such
Portfolio. No charge or penalty will be imposed as a result of such
withdrawal. This requirement will be provided for in the agreements
entered into with respect to participation by the Participating
Insurance Companies in each Portfolio.
    20. Each Portfolio will be managed to attempt to achieve the
investment objective or objectives of such Portfolio, and not to favor
or disfavor any particular Participating Insurance Company or type of
insurance product. There is no reason to believe that different
features of various types of contracts, including the ``minimum death
benefit'' guarantee under certain variable life insurance contracts,
will lead to different investment policies for different types of
Variable Contracts. To the extent that the degree of risk may differ as
between variable annuity contracts and variable life insurance
policies, the different insurance charges imposed, in effect, adjust
any such differences and equalize the insurers' exposure in either
case.
    21. Applicants do not believe that the sale of the shares of the
Portfolios to Qualified Plans will increase the potential for material
irreconcilable conflicts of interest between or among different types
of investors. In particular, Applicants see very little potential for
such conflicts beyond those which would otherwise exist between
variable annuity and variable life insurance contract owners. Moreover,
in considering the appropriateness of the requested relief, Applicants
have analyzed the following issues to assure themselves that there

were either no conflicts of interest or that there existed the ability
by the affected parties to resolve the issues without harm to the
contract owners in the Separate Accounts or to the participants under
the Qualified Plans.
    22. Applicants considered whether there are any issues raised under
the Internal Revnue Code of l986, as amended, (the ``Code''), the
regulations issued by the Treasury Department (the ``Regulations''), or
the revenue rulings issued by the Internal Revenue Service (the
``Revenue Rulings''), if Qualified Plans, variable annuity separate
accounts, and variable life insurance separate accounts all invest in
the same underlying fund. Section 817(h) of the Code imposes certain
diversification standards on the underlying assets of Variable
Contracts held in an underlying mutual fund. The Code provides that a
Variable Contract shall not be treated as an annuity contract or life
insurance, as applicable, for any period (and any subsequent period)
for which the investments are not, in accordance with regulations
prescribed by the Treasury Department, adequately diversified.
    23. Regulations issued under Section 817(h) provide that, in order
to meet the statutory diversification requirements, all of the
beneficial interests in the investment company must be held by the
segregated asset accounts of one or more insurance companies. However,
the Regulations contain certain exceptions to this requirement, one of
which allows shares in an underlying mutual fund to be held by the
trustees of a qualified pension or retirement plan without adversely
affecting the ability of such shares also to be held by separate
accounts of insurance companies in connection with their Variable
Contracts. Thus, the Regulations specifically permit ``qualified
pension or retirement plans'' and separate accounts to invest in the
same underlying fund. For this reason, Applicants have concluded that
neither the Code, nor Regulations, nor Revenue Rulings thereunder,
present any inherent conflicts of interest if the Qualified Plans and
Separate Accounts all invest in the same Portfolio.
    24. Applicants note that while there are differences in the manner
in which distributions from Variable Contracts and Qualified Plans are
taxed, these differences will have no impact on the Trusts. When
distributions are to be made, and a Separate Account or Qualified Plan
is unable to net purchase payments to make the distributions, the
Separate Account and Qualified Plan will redeem shares of the relevant
Portfolio at their respective net asset value in conformity with Rule
22c-1 under the 1940 Act (without the imposition of any sales charge)
to provide proceeds to meet distribution needs. A Participating
Insurance Company then will make distributions in accordance with the
terms of its Variable Contract, and a Qualified Plan then will make
distributions in accordance with the terms of the Qualified Plan.
    25. In connection with any meeting of shareholders, the soliciting
Trust will inform each shareholder, including each Separate Account,
Qualified Plan, Wilshire Entities, and General Account, of information
necessary for the meeting, including their respective share of
ownership in the relevant Portfolio. Each Participating Insurance
Company then will solicit voting instructions in accordance with Rules
6e-2 and 6e-3(T), as applicable, and its agreement with the Trusts
concerning participation in the relevant Portfolio. Shares of a
Portfolio that are held by Wilshire Entities and any General Account
will be voted in the same proportion as all Variable Contract owners
having voting rights with respect to that Portfolio. However, Wilshire
Entities and any General Account will vote their shares in such other
manner as the Commission may require. Shares held by Qualified Plans
will be voted in accordance with applicable law. The voting rights
provided to Qualified Plans with respect to shares of a Portfolio would
be no different from the voting rights that are provided to Qualified
Plans with respect to shares of funds sold to the general public.
Furthermore, if a material irreconcilable conflict arises because of a
Qualified Plan's decision to disregard Qualified Plan participant
voting instructions, if applicable, and that decision represents a
minority position or would preclude a majority vote, the Qualified Plan
may be required, at the election of the affected Trust, to withdraw its
investment in such Portfolio, and no charge or penalty will be imposed
as a result of such withdrawal.
    26. Applicants reviewed whether a ``senior security,'' as such term
is defined under Section 18(g) of the 1940 Act, is created with respect
to any Variable Contract owner as opposed to a participant under a
Qualified Plan, Wilshire Entities, or a General Account. Applicants
concluded that the ability of the Trusts to sell shares of their
Portfolios directly to Qualified Plans, Wilshire Entities, or a General
Account does not create a senior security. ``Senior security'' is
defined under Section 18(g) of the 1940 Act to include ``any stock of a
class having priority over any other class as to distribution of assets
or payment of dividends.'' As noted above, regardless of the rights and
benefits of participants under Qualified Plans, or contract owners
under Variable Contracts, the Qualified Plans, Wilshire Entities,
General Accounts and the Separate Accounts only have rights with
respect to their respective shares of the Portfolio. They only can
redeem such shares at net asset value. No shareholder of a Portfolio
has any preference over any other shareholder with respect to
distribution of assets or payment of dividends.

Applicants' Conditions

    Applicants and the Wilshire Entities agree that the order granting
the requested relief shall be subject to the following conditions which
shall apply to the Trust as well as any Future Trust that relies on the
order:
    1. A majority of the Board of Trustees (the ``Board'') of the Trust
will consist of persons who are not ``interested persons'' of the
Trust, as defined by Section 2(a)(19) of the 1940 Act, and the rules
thereunder, and as modified by any applicable orders of the Commission,
except that if this condition is not met by reason of the death,
disqualification, or bona fide resignation of any trustee or trustees,
then the operation of this condition will be suspended: (a) For a
period of 90 days if the vacancy or vacancies may be filled by the
Board; (b) for a period of 150 days if a vote of shareholders is
required to fill the vacancy or vacancies; or (c) for such longer
period as the Commission may prescribe by order upon application or by
future rule.
    2. The Board will monitor the Trust for the existence of any
material irreconcilable conflict between the interests of the contract
owners of all Separate Accounts and participants of all Qualified Plans
investing in such Trust, and determine what action, if any, should be
taken in response to such conflicts. A material irreconcilable conflict
may arise for a variety of reasons, including: (a) An action by any
State insurance regulatory authority; (b) a change in applicable
Federal or State insurance tax, or securities laws or regulations, or a
public ruling, private letter ruling, no-action or interpretative
letter, or any similar action by insurance, tax, or securities
regulatory authorities; (c) an administrative or judicial decision in
any relevant proceeding; (d) the manner in which the investments of
such Trust are being managed; (e) a difference in voting instructions
given by variable annuity contract owners, variable life insurance

contract owners, and trustees of the Qualified Plans; (f) a decision by
a Participating Insurance Company to disregard the voting instructions
of contract owners; or (g) if applicable, a decision by a Qualified
Plan to disregard the voting instructions of Qualified Plan
participants.
    3. Participating Insurance Companies (on their own behalf, as well
as by virtue of any investment of general account assets in a
Portfolio), Wilshire Entities, and any Qualified Plan that executes a
participation agreement upon becoming an owner of 10 percent or more of
the assets of any Portfolio (collectively, ``Participants'') will
report any potential or existing conflicts to the Board. Participants
will be responsible for assisting the Board in carrying out the Board's
responsibilities under these conditions by providing the Board with all
information reasonably necessary for the Board to consider any issues
raised. This responsibility includes, but is not limited to, an
obligation by each Participating Insurance Company to inform the Board
whenever contract owner voting instructions are disregarded, and, if
pass-through voting is applicable, an obligation by each Qualified Plan
to inform the Board whenever it has determined to disregard Qualified
Plan participant voting instructions. The responsibility to report such
information and conflicts, and to assist the Board, will be a
contractual obligation of all Participating Insurance Companies under
their participation agreements with the Trust, and these
responsibilities will be carried out with a view only to the interests
of the contract owners. The responsibility to report such information
and conflicts, and to assist the Board, also will be contractual
obligations of all Qualified Plans with participation agreements, and
such agreements will provide that these responsibilities will be
carried out with a view only to the interests of Qualified Plan
participants.
    4. If it is determined by a majority of the Board, or a majority of
the disinterested trustees of the Board, that a material irreconcilable
conflict exists, then the relevant Participant will, at its expense and
to the extent reasonably practicable (as determined by a majority of
the disinterested trustees), take whatever steps are necessary to
remedy or eliminate the material irreconcilable conflict, up to and
including: (a) Withdrawing the assets allocable to some or all of the
Separate Accounts from the relevant Portfolio and reinvesting such
assets in a different investment vehicle including another Portfolio,
or in the case of Participating Insurance Company Participants
submitting the question as to whether such segregation should be
implemented to a vote of all affected contract owners and, as
appropriate, segregating the assets of any appropriate group (i.e.,
annuity contract owners or life insurance contract owners of one or
more Participating Insurance Companies) that votes in favor of such
segregation, or offering to the affected contract owners the option of
making such a change; (b) establishing a new registered management
investment company or managed separate account; and (c) withdrawing the
assets allocable to some or all of the Qualified Plans from the
affected Portfolio or Participating Insurance Company and reinvesting
those assets in a different investment medium. If a material
irreconcilable conflict arises because of a decision by a Participating
Insurance Company to disregard contract owner voting instructions, and
that decision represents a minority position or would preclude a
majority vote, then the insurer may be required, at the election of the
Trust, to withdraw such insurer's Separate Account's investment in the
Trust, and no charge or penalty will be imposed as a result of such
withdrawal. If a material irreconcilable conflict arises because of a
Qualified Plan's decision to disregard Qualified Plan participant
voting instructions, if applicable, and that decision represents a
minority position or would preclude a majority vote, the Qualified Plan
may be required, at the election of the Trust, to withdraw its
investment in the Trust, and no charge or penalty will be imposed as a
result of such withdrawal. The responsibility to take remedial action
in the event of a Board determination of a material irreconcilable
conflict and to bear the cost of such remedial action will be a
contractual obligation of all Participants under their agreements
governing participation in the Trust, and these responsibilities will
be carried out with a view only to the interests of contract owners and
Qualified Plan participants.
    For purposes of this Condition 4, a majority of the disinterested
members of the Board will determine whether or not any proposed action
adequately remedies any material irreconcilable conflict, but, in no
event will the Trust or Wilshire, as relevant, be required to establish
a new funding vehicle for any Variable Contract. No Participating
Insurance Company will be required by this Condition 4 to establish a
new funding vehicle for any Variable Contract if any offer to do so has
been declined by vote of a majority of the contract owners materially
and adversely affected by the material irreconcilable conflict.
Further, no Qualified Plan will be required by this Condition 4 to
establish a new funding vehicle for the Qualified Plan if: (a) A
majority of the Qualified Plan participants materially and adversely
affected by the irreconcilable material conflict vote to decline such
offer, or (b) pursuant to documents governing the Qualified Plan, the
Qualified Plan makes such decision without a Qualified Plan participant
vote.
    5. The Board's determination of the existence of a material
irreconcilable conflict and its implications will be made known in
writing promptly to all Participants.
    6. As to Variable Contracts issued by Separate Accounts registered
under the 1940 Act, Participating Insurance Companies will provide
pass-through voting privileges to all Variable Contract owners as
required by the 1940 Act as interpreted by the Commission. However, as
to Variable Contracts issued by unregistered Separate Accounts, pass-
through voting privileges will be extended to contract owners to the
extent granted by the issuing insurance company. Accordingly, such
Participants, where applicable, will vote shares of the applicable
Portfolio held in their Separate Accounts in a manner consistent with
voting instructions timely received from Variable Contract owners.
Participating Insurance Companies will be responsible for assuring that
each Separate Account investing in a Portfolio calculates voting
privileges in a manner consistent with other Participants.
    The obligation to calculate voting privileges as provided in this
Application will be a contractual obligation of all Participating
Insurance Companies under their agreement with the Trusts governing
participation in a Portfolio. Each Participating Insurance Company will
vote shares for which it has not received timely voting instructions,
as well as shares it owns through its General Account or otherwise
attributed to it, in the same proportion as it votes those shares for
which it has received voting instructions. Each Qualified Plan will
vote as required by applicable law and governing Qualified Plan
documents.
    7. As long as the 1940 Act requires pass-through voting privileges
to be provided to variable contract owners, Wilshire Entities and any
General Account will vote their respective shares of any Portfolio in
the same proportion of all variable contract owners having voting
rights with respect to that Portfolio; provided;

however, that any Wilshire Entity or any insurance company General
Account shall vote its shares in such other manner as may be required
by the Commission or its staff.
    8. The Trust will comply with all provisions of the 1940 Act
requiring voting by shareholders, which for these purposes, shall be
the persons having a voting interest in the shares of the respective
Portfolio, and, in particular, the Trust will either provide for annual
meetings (except to the extent that the Commission may interpret
Section 16 of the 1940 Act not to require such meetings) or comply with
Section 16(c) of the 1940 Act (although the Trust is not one of the
funds of the type described in the Section 16(c) of the 1940 Act), as
well as with Section 16(a) of the 1940 Act and, if and when applicable,
Section 16(b) of the 1940 Act. Further, the Trust will act in
accordance with the Commission's interpretation of the requirements of
Section 16(a) with respect to periodic elections of trustees and with
whatever rules the Commission may promulgate with respect thereto.
    9. The Trust will notify all Participants that Separate Account
prospectus disclosure or Qualified Plan prospectuses or other Qualified
Plan disclosure documents regarding potential risks of mixed and shared
funding may be appropriate. The Trust will disclose in its prospectus
that (a) Shares of the Trust may be offered to Separate Accounts of
both variable annuity and variable life insurance contracts and, if
applicable, to Qualified Plans; (b) due to differences in tax treatment
and other considerations, the interests of various contract owners
participating in the Trust and the interests of Qualified Plans
investing in the Trust, if applicable, may conflict; and (c) the
Trust's Board will monitor events in order to identify the existence of
any material irreconcilable conflicts and to determine what action, if
any, should be taken in response to any such conflict.
    10. If and to the extent that Rule 6e-2 and Rule 6e-3(T) under the
1940 Act are amended, or proposed Rule 6e-3 under the 1940 Act is
adopted, to provide exemptive relief from any provision of the 1940
Act, or the rules promulgated thereunder, with respect to mixed or
shared funding, on terms and conditions materially different from any
exemptions granted in the order requested in this Application, then the
Trust and/or Participating Insurance Companies, as appropriate, shall
take such steps as may be necessary to comply with Rules 6e-2 and 6e-
3(T), or Rule 6e-3, as such rules are applicable.
    11. The Participants, at least annually, will submit to the Board
such reports, materials, or data as a Board reasonably may request so
that the trustees of the Board may fully carry out the obligations
imposed upon the Board by the conditions contained in this application.
Such reports, materials, and data will be submitted more frequently if
deemed appropriate by the Board. The obligations of the Participants to
provide these reports, materials, and data to the Board, when it so
reasonably requests, will be a contractual obligation of all
Participants under their agreements governing participation in the
Portfolios.
    12. All reports of potential or existing conflicts received by the
Board, and all Board action with regard to determining the existence of
a conflict, notifying Participants of a conflict, and determining
whether any proposed action adequately remedies a conflict, will be
properly recorded in the minutes of the Board or other appropriate
records, and such minutes or other records shall be made available to
the Commission upon request.
    13. The Trust will not accept a purchase order from a Qualified
Plan if such purchase would make the Qualified Plan shareholder an
owner of 10 percent or more of the assets of such Portfolio unless such
Qualified Plan executes an agreement with the Trust governing
participation in such Portfolio that includes the conditions set forth
herein to the extent applicable. A Qualified Plan or Qualified Plan
participant will execute an application containing an acknowledgment of
this condition at the time of its initial purchase of shares of any
Portfolio.
    14. A Portfolio will make its shares available under a Variable
Contract and/or Qualified Plan at or about the same time as it accepts
any seed capital from any Wilshire Entity or any General Account of a
Participating Insurance Company.

Conclusions

    Applicants submit, based on the grounds summarized above, that the
exemptions requested are 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 1940 Act.

    For the Commission, by the Division of Investment Management,
pursuant to delegated authority.
Florence E. Harmon,
Deputy Secretary.
[FR Doc. E7-3068 Filed 2-22-07; 8:45 am]

BILLING CODE 8010-01-P