[Federal Register Volume 76, Number 184 (Thursday, September 22, 2011)]
[Notices]
[Pages 58850-58851]
[FR Doc No: 2011-24331]

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SECURITIES AND EXCHANGE COMMISSION

[Investment Company Act Release No. 29790; File No. 812-13890]

Highland Capital Management, L.P., et al.; Notice of Application

September 15, 2011.

AGENCY: Securities and Exchange Commission (``Commission'').

ACTION: Notice of an application under section 6(c) of the Investment
Company Act of 1940 (``Act'') for an exemption from rule 12d1-2(a)
under the Act.

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Summary of Application: Applicants request an order to permit open-end
management investment companies relying on rule 12d1-2 under the Act to
invest in certain financial instruments.
    Applicants: Highland Capital Management, L.P. (``HCM''), Highland
Funds Asset Management, L.P. (``HFAM''), Highland Funds I (``HFI'') and
Highland Funds II (``HFII'').
    Filing Dates: The application was filed on April 8, 2011, and
amended on August 15, 2011, and September 15, 2011.
    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 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 October 11, 2011, 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
writer'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 Commission's Secretary.

ADDRESSES: Secretary, Securities and Exchange Commission, 100 F Street,
NE., Washington, DC 20549-1090; Applicants: NexBank Tower, 13455 Noel
Road, Suite 800, Dallas, TX 75240.

FOR FURTHER INFORMATION CONTACT: Jean E. Minarick, Senior Counsel, at
(202) 551-6811, or Daniele Marchesani, Branch Chief, at<PHONE_NUMBER>
(Division of Investment Management, Office of Investment Company
Regulation).

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 an applicant
using the Company name box, at http://www.sec.gov/search/search.htm or
by calling<PHONE_NUMBER>.

Applicants' Representations

    1. HFI is organized as a Delaware statutory trust and HFII as a
Massachusetts unincorporated business trust (HFI and HFII, collectively
the ``Trusts''). Each is registered under the Act as an open-end
management investment company. HCM is organized as a Delaware limited
partnership and is registered as an investment adviser under the
Investment Advisers Act of 1940, as amended (``Advisers Act''). HCM
currently serves as investment adviser to a number of registered
investment companies, including HFI. HFAM is organized as a Delaware
limited partnership and is registered as an investment adviser under
the

Advisers Act. HFAM currently serves as investment adviser to HFII.
    2. Applicants request the exemption to the extent necessary to
permit any series of the Trusts and any other existing or future
registered open-end management investment company or series thereof
that (i) is advised by HCM, HFAM or any person controlling, controlled
by, or under common control with HCM or HFAM (any such adviser or HCM
or HFAM, an ``Adviser''); \1\ (ii) is in the same group of investment
companies as defined in section 12(d)(1)(G) of the Act as the Trusts;
(iii) invests in other registered open-end management investment
companies (``Underlying Funds'') in reliance on section 12(d)(1)(G) of
the Act; and (iv) is also eligible to invest in securities (as defined
in section 2(a)(36) of the Act) in reliance on rule 12d1-2 under the
Act (each a ``Fund of Funds''), to also invest, to the extent
consistent with its investment objectives, policies, strategies and
limitations, in financial instruments that may not be securities within
the meaning of section 2(a)(36) of the Act (``Other Investments'').\2\
Applicants also request that the order exempt any entity, including any
entity controlled or under common control with an Adviser, that now or
in the future acts as principal underwriter, or broker or dealer (if
registered under the Securities Exchange Act of 1934, as amended
(``Exchange Act'')), with respect to the transactions described in the
application.
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    \1\ Any other Adviser also will be registered under the Advisers
Act.
    \2\ Every existing entity that currently intends to rely on the
requested order is named as an applicant. Any entity that relies on
the requested order in the future will do so only in accordance with
the terms and condition in the application.
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    3. Consistent with its fiduciary obligations under the Act, each
Fund of Funds' board of trustees will review the advisory fees charged
by the Fund of Funds' Adviser to ensure that they are based on services
provided that are in addition to, rather than duplicative of, services
provided pursuant to the advisory agreement of any investment company
in which the Fund of Funds may invest.

Applicants' Legal Analysis

    1. Section 12(d)(1)(A) of the Act provides that no registered
investment company (``acquiring company'') may acquire securities of
another investment company (``acquired company'') if such securities
represent more than 3% of the acquired company's outstanding voting
stock or more than 5% of the acquiring company's total assets, or if
such securities, together with the securities of other investment
companies, represent more than 10% of the acquiring company's total
assets. Section 12(d)(1)(B) of the Act provides that no registered
open-end investment company may sell its securities 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 cause more than
10% of the acquired company's voting stock to be owned by investment
companies and companies controlled by them.
    2. Section 12(d)(1)(G) of the Act provides, in part, that section
12(d)(1) will not apply to securities of an acquired company purchased
by an acquiring company if: (i) The acquired company and acquiring
company are part of the same group of investment companies; (ii) the
acquiring company holds only securities of acquired companies that are
part of the same group of investment companies, government securities,
and short-term paper; (iii) the aggregate sales loads and distribution-
related fees of the acquiring company and the acquired company are not
excessive under rules adopted pursuant to section 22(b) or section
22(c) of the Act by a securities association registered under section
15A of the Exchange Act, as amended, or by the Commission; and (iv) the
acquired company has a policy that prohibits it from acquiring
securities of registered open-end investment companies or registered
unit investment trusts in reliance on section 12(d)(1)(F) or (G) of the
Act.
    3. Rule 12d1-2 under the Act permits a registered open-end
investment company or a registered unit investment trust that relies on
section 12(d)(1)(G) of the Act to acquire, in addition to securities
issued by another registered investment company in the same group of
investment companies, government securities, and short-term paper: (i)
Securities issued by an investment company that is not in the same
group of investment companies, when the acquisition is in reliance on
section 12(d)(1)(A) or 12(d)(1)(F) of the Act; (ii) securities (other
than securities issued by an investment company); and (iii) securities
issued by a money market fund, when the investment is in reliance on
rule 12d1-1 under the Act. For the purposes of rule 12d1-2,
``securities'' means any security as defined in section 2(a)(36) of the
Act.
    4. Section 6(c) of the Act provides that the Commission may exempt
any person, security, or transaction from any provision of the Act, or
from any rule under the Act, if such exemption is necessary or
appropriate in the public interest and consistent with the protection
of investors and the purposes fairly intended by the policies and
provisions of the Act.
    5. Applicants state that the Funds of Funds will comply with Rule
12d1-2 under the Act, but for the fact that the Funds of Funds may
invest a portion of their assets in Other Investments. Applicants
request an order under section 6(c) of the Act for an exemption from
rule 12d1-2(a) to allow the Funds of Funds to invest in Other
Investments while investing in Underlying Funds. Applicants assert that
permitting the Funds of Funds to invest in Other Investments as
described in the application would not raise any of the concerns that
the requirements of section 12(d)(1) were designed to address.

Applicants' Condition

    Applicants agree that any order granting the requested relief will
be subject to the following condition:
    Applicants will comply with all provisions of rule 12d1-2 under the
Act, except for paragraph (a)(2) to the extent that it restricts any
Fund of Funds from investing in Other Investments as described in the
application.

    For the Commission, by the Division of Investment Management,
under delegated authority.
Elizabeth M. Murphy,
Secretary.
[FR Doc. 2011-24331 Filed 9-21-11; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 77, Number 44 (Tuesday, March 6, 2012)]
[Notices]
[Pages 13343-13344]
[FR Doc No: 2012-5311]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0788]

Pilot Program for Early Feasibility Study Investigational Device
Exemption Applications; Termination of Acceptance of Nominations and
Extending the Duration of the Program

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
termination of the acceptance of nominations for the Early Feasibility
Study Investigational Device Exemption (IDE) Applications pilot
program. This program allowed the submission of nominations from
sponsors of innovative device technologies to participate in a pilot
program for early feasibility study IDE applications. FDA is also
announcing that the duration of the pilot program is extended to May 8,
2013, for sponsors that have already been accepted for the program.

DATES: This notice is effective March 6, 2012.

FOR FURTHER INFORMATION CONTACT: Sheila Brown, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1676, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In the Federal Register of November 10, 2011
(76 FR 70150), FDA announced the availability of a draft guidance
entitled ``Investigational Device Exemptions (IDE) for Early
Feasibility Medical Device Clinical Studies, Including Certain First in
Human (FIH) Studies.'' This guidance document is intended to facilitate
early feasibility studies of medical devices, using appropriate risk
mitigation strategies, under the IDE requirements. Simultaneous with
the publication of the draft guidance, FDA also announced an Early
Feasibility Study IDE Pilot Program (76 FR 70152, November 10, 2011)
intended to collect

information and experience on the application of the draft guidance in
order to inform the final guidance document.
    FDA began accepting nominations for the pilot program on December
12, 2011. In the Federal Register notice announcing the pilot program,
FDA stated its intention to limit the pilot program to nine candidates.
After review of the nominations received in response to the pilot
program notice, FDA accepted nine appropriate candidates for the pilot
program.
    In the pilot program notice, FDA stated its intention to accept
nominations to participate in the pilot program until May 8, 2012.
Because FDA has already accepted nine sponsors to participate in the
program, FDA will no longer accept nominations to participate in the
program and will conduct the pilot program for the nine sponsors that
have already been accepted.
    In the pilot program notice, FDA also stated that the pilot program
will terminate on May 8, 2012. Instead, the pilot program will be
extended for the nine accepted sponsors until May 8, 2013.

    Dated: February 28, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-5311 Filed 3-5-12; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 76, Number 244 (Tuesday, December 20, 2011)]
[Notices]
[Pages 78929-78930]
[FR Doc No: 2011-32438]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0849]

Establishing Timeframes for Implementation of Product Safety
Labeling Changes; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is seeking comments on
specific issues related to its authority under the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) to require or order safety labeling
changes for approved prescription drug products based on new safety
information that becomes available after a drug product is approved.
The FD&C Act specifies the timeframes within which a safety labeling
change must be submitted when required or ordered by the FDA, and
timeframes for FDA to conclude its review and take regulatory action
regarding safety labeling changes. FDA's regulations also provide
procedures by which labeling changes that do not qualify as changes
based on new safety information can be requested by FDA or by the
holder of the drug approval. FDA is seeking public input to assist the
Agency in establishing specific timeframes for implementing both types
of labeling changes.

DATES: Submit either electronic or written comments by February 21,
2012.

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

FOR FURTHER INFORMATION CONTACT: Kristen Miller, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6226, Silver Spring, MD 20993-0002, (301)
796-0762, Fax:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    On September 27, 2007, the Food and Drug Administration Amendments
Act of 2007 (FDAAA) was enacted. Title IX, Subtitle A, section 901 of
FDAAA added to the FD&C Act new section 505(o) (21 U.S.C. 355(o)),
which authorizes FDA to require labeling changes when the Agency
becomes aware of new safety information it believes should be included
in the labeling of an approved drug product.\1\
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    \1\ For purposes of this notice, drug product means a human drug
product including a biological drug product. Labeling includes the
carton or other container or packaging labels, the prescribing
information, patient package inserts, and Medication Guides.
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    Before the enactment of FDAAA, if FDA believed that a labeling
change was necessary to address safety information newly identified
after approval of a drug product, the Agency would ask the application
holder to make the appropriate labeling changes. In most cases,
application holders responded to FDA's requests for labeling changes by
negotiating appropriate language with FDA staff to address the concern,
and then submitting a supplement or amended supplement to obtain
approval of the changes. FDA routinely asked applicants to submit
supplemental applications to revise the labeling of approved products,
but the Agency lacked the authority to compel changes to product
labeling based on new safety information. At times, FDA and application
holders discussed the appropriate timeframe by which new labeling would
be made available. Typically products that had already moved beyond the
manufacturing line were not withdrawn from distribution to change
existing labeling under the timeframes.
    Under FDAAA, FDA is now authorized to require and, if necessary,
order application holders to implement safety labeling changes to
reflect new safety information (section 505(o)(4) of the FD&C Act).
Although the statute provides specific and relatively short timelines
for submission and review of FDAAA-required safety labeling changes
following a notification or order from FDA, the statute does not
include specific deadlines for how soon the revised labeling must be
incorporated into the packaging of the product that is offered for
sale, or into other labeling (section 505(o)(4) of the FD&C Act).
    In an effort to make revised safety labeling available as soon as
possible after the changes required under FDAAA are approved, FDA has
recommended that application holders post the revised labeling on their
Web sites within 10 days of approval. (See draft guidance for industry
entitled ``Safety Labeling Changes--Implementation of Section 505(o)(4)
of the Federal Food, Drug, and Cosmetic Act'' (76 FR 20686, April 13,
2011)). In letters approving supplements with safety labeling changes,
FDA has also recommended that revised labeling accompany the product
within ``a reasonable amount of time'' and has occasionally suggested
specific timeframes when this could occur. However, we have not yet
announced general timeframes in which we expect new labeling to be
disseminated nor have we established the timeframe for when product
packaging needs to reflect the revised label.
    In addition to safety labeling changes that may be required under
FDAAA, FDA may continue to request safety labeling changes under
existing regulations and application holders may continue to propose
labeling changes on their own initiative (Sec. Sec.  314.70 and 601.12
(21 CFR 314.70 and 601.12)). Existing regulations in Sec. Sec.  314.70
and 601.12 describe several mechanisms for effecting proposed labeling
changes to approved drug applications including the following: (1) A
prior approval supplement (PAS) is used for changes that must receive
approval before being implemented; (2) a changes-being-effected
supplement (CBE) is used for other kinds of labeling revisions that
must be received by the Agency prior to distribution of the drug with
the revised labeling; and (3) the annual report for the drug product is
used for certain minor changes that need only be described in the next
annual report.
    Current labeling regulations do not provide specific timeframes for
implementing other safety labeling changes--changes not required under
FDAAA--that are made by submitting a PAS or CBE, or by reporting the
change in the annual report.

II. Purpose of Request for Comments

    Because safety labeling changes may be related to serious risks,
this information must be promptly communicated to prescribers and
patients. Thus, it is important for FDA to clarify its expectations
regarding the timeframes for applicants to implement safety labeling
changes to ensure that the labeling is updated in a timely manner. FDA
anticipates that in most cases, as in the past, it will not be
necessary for products with existing labeling to be withdrawn from
distribution and that under certain circumstances it may be appropriate
for products with existing labeling to remain in distribution until the
current product inventory is exhausted.
    FDA is interested in hearing from application holders,
manufacturers, distributors, and other stakeholders about their
experience with and views on the practical implementation of revised
product labeling, including their views as to how factors in the
following

three categories may affect implementation: (1) Drug manufacturing and
packaging, and printing labels and other labeling; (2) supply chain
issues; and, (3) other issues. FDA may use the information received to
develop draft guidance for industry regarding timeframes for revising
product labeling following the approval of safety labeling changes, and
may apply these timeframes to particular safety labeling changes.

III. Questions Posed by FDA

    With this notice, FDA is soliciting comments from application
holders, manufacturers, distributors, and other stakeholders on the
following questions:

A. Considerations Related to Drug Manufacturing and Packaging, and to
Printing Labeling

    1. What are the considerations related to drug manufacturing and
packaging, of which FDA should be aware, as they relate to
implementation of revised product labeling?
    2. What are the considerations related to printing labels and other
types of labeling of which FDA should be aware, as they relate to
implementation of different types of revised product labeling?

B. Supply Chain Issues

    3. What are the supply chain factors (including storage, shipping,
and distribution factors) of which FDA should be aware that limit or
otherwise affect how quickly a labeling change can be implemented?

C. Other Considerations

    4. What alternative labeling mechanisms (e.g., having labeling
available on a product Web site) could be used to disseminate new
safety information quickly to patients and health care providers?
    5. How should the relative seriousness of the new safety
information, or whether the new safety information describes a newly
identified risk, or strengthens a risk already identified in current
labeling, affect timelines for implementing revised product labeling?
    6. What are the implementation considerations when the safety
labeling change is to prescriber versus patient labeling (or both)?
    7. What would be a reasonable timeframe following approval of
revised safety related labeling changes for applicants to implement the
revised labeling? Please relate this timeframe to the optimal point in
the supply chain (e.g., newly manufactured product, newly shipped
product) and the type of labeling change.
    8. Are there other considerations or options related to
implementing safety labeling changes of which FDA should be aware?

IV. Comments

    Interested persons may submit either electronic or written comments
regarding this document to the Division of Dockets Management (see
ADDRESSES). It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen at the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday, as well as
at http://www.regulations.gov.

    Dated: December 14, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-32438 Filed 12-19-11; 8:45 am]
BILLING CODE 4160-01-P