[Federal Register: August 25, 2009 (Volume 74, Number 163)]
[Notices]
[Page 42907]
[DOCID:fr25au09-86]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0664]

Oncologic Drugs Advisory Committee; Notice of Meeting

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.

    Name of Committee: Oncologic Drugs Advisory Committee.
    General Function of the Committee: To provide advice and
recommendations to the agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on October 6, 2009, from
8 a.m. to 4 p.m.
    Location: Hilton Washington DC North/Gaithersburg, The
Ballrooms, 620 Perry Pkwy., Gaithersburg, MD. The hotel phone number
is<PHONE_NUMBER>.
    Contact Person: Nicole Vesely, Center for Drug Evaluation and
Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane
(for express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD
20857,<PHONE_NUMBER>, FAX:<PHONE_NUMBER>, e-mail:
<EMAIL_ADDRESS>or FDA Advisory Committee Information
Line, 1-800-741-8138<PHONE_NUMBER> in the Washington, DC area), code
3014512542. Please call the Information Line for up-to-date
information on this meeting. A notice in the Federal Register about
last minute modifications that impact a previously announced
advisory committee meeting cannot always be published quickly enough
to provide timely notice. Therefore, you should always check the
agency's Web site and call the appropriate advisory committee hot
line/phone line to learn about possible modifications before coming
to the meeting.
    Agenda: The committee will discuss new drug application (NDA)
021-825, proposed trade name FERRIPROX (deferiprone) film-coated
tablets and oral solution, manufactured by ApoPharma Inc. The
proposed indications (uses) for this product is as an iron chelating
agent, which is a drug that binds with iron in the body and helps to
make elimination of iron easier, reducing iron build-up. There are
two specific proposed indications (uses) of FERRIPROX: (1) the
treatment of iron overload, or build-up in patients with
transfusion-dependent thalassemia, an inherited blood disorder that
necessitates frequent transfusion of normal blood which can lead to
iron build-up due to the iron content in the blood a patient
receives; and (2) for the treatment of iron overload in patients
with other transfusion-dependent anemias (other blood disorders that
require frequent transfusions) for which the use of other iron
chelating agents has been considered inappropriate.
    FDA intends to make background material available to the public
no later than 2 business days before the meeting. If FDA is unable
to post the background material on its Web site prior to the
meeting, the background material will be made publicly available at
the location of the advisory committee meeting, and the background
material will be posted on FDA's Web site after the meeting.
Background material is available at http://www.fda.gov/
AdvisoryCommittees/Calendar/default.htm. Scroll down to the
appropriate advisory committee link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
September 21, 2009. Oral presentations from the public will be
scheduled between approximately 1 p.m. and 2 p.m. Those desiring to
make formal oral presentations should notify the contact person and
submit a brief statement of the general nature of the evidence or
arguments they wish to present, the names and addresses of proposed
participants, and an indication of the approximate time requested to
make their presentation on or before September 11, 2009. Time
allotted for each presentation may be limited. If the number of
registrants requesting to speak is greater than can be reasonably
accommodated during the scheduled open public hearing session, FDA
may conduct a lottery to determine the speakers for the scheduled
open public hearing session. The contact person will notify
interested persons regarding their request to speak by September 14,
2009.
    Persons attending FDA's advisory committee meetings are advised
that the agency is not responsible for providing access to
electrical outlets.
    FDA welcomes the attendance of the public at its advisory
committee meetings and will make every effort to accommodate persons
with physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Nicole Vesely at
least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory
committee meetings. Please visit our Web site at http://www.fda.gov/
AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for
procedures on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: August 19, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-20378 Filed 8-24-09; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register: December 9, 2009 (Volume 74, Number 235)]
[Notices]
[Page 65175-65178]
[DOCID:fr09de09-112]

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SECURITIES AND EXCHANGE COMMISSION

[Investment Company Act Release No. 29066; File No. 812-13640]

PNC Bank, National Association; Notice of Application

December 3, 2009.
AGENCY: Securities and Exchange Commission (``Commission'').

ACTION: Notice of an application for an order under section 6(c) of the
Investment Company Act of 1940 (``Act'') granting an exemption from
section 18(f)(1) of the Act.

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Applicant: PNC Bank, National Association (``PNC Bank'').

Summary of the Application: Applicant requests an order that that would
permit certain registered open-end management investment companies to
participate as borrowers in loan facilities to be administered by PNC
Bank.

Filing Dates: The application was filed on March 11, 2009, and amended
on November 30, 2009.

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 December 28, 2009 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 by
writing to the Commission's Secretary.

ADDRESSES: Secretary, U.S. Securities and Exchange Commission, 100 F
Street, NE., Washington, DC 20549-1090. Applicant, PNC Bank, National
Association, One PNC Plaza, 21st Floor, 249 Fifth Avenue, Pittsburgh,
PA 15222.

FOR FURTHER INFORMATION CONTACT: Lewis B. Reich, Senior Counsel, at
(202) 551-6919, or Mary Kay Frech, Branch Chief, at<PHONE_NUMBER>
(Office of Investment Company Regulation, Division of Investment
Management).

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

Applicant's Representations

    1. PNC Bank, a wholly-owned indirect subsidiary of The PNC
Financial Services Group, Inc. (``PNC Financial''), is a national
banking association with its principal office in Pittsburgh,
Pennsylvania. PNC Financial is one of the largest diversified financial
services companies in the United States based on assets, with
businesses engaged in retail banking, corporate and institutional
banking, asset management, and global fund processing services. PNC
Bank has extensive experience and expertise as an administrator of
asset-backed commercial paper programs, having administered the
commercial paper program of Market Street Funding LLC (``Market
Street''), a limited purpose securitization entity, since 1995.
    2. Market Street is organized as a Delaware limited liability
company and is exempt from registration under the Act in reliance on
section 3(c)(7) of the Act. All of the membership interests of Market
Street are owned by Market Street Holding Corporation (``MSHC''). All
of the capital stock of MSHC is owned by Amacar Investments, LLC, an
entity unaffiliated with PNC Financial. As of September 30, 2009,
Market Street's purchase commitments totaled approximately $6.0
billion, and its outstanding loans and other assets totaled
approximately $3.3 billion.
    3. PNC Bank requests relief to permit any registered open-end
management investment company or series thereof to participate from
time to time as a borrower (``Borrowing Fund'') in a loan facility to
be administered by PNC Bank (``Loan Facility''). Market Street, which
would be the principal source of financing for each Loan Facility, will
issue commercial paper and will utilize liquidity support provided by
highly rated financial institutions that are ``banks'' within the
meaning of section 2(a)(5) of the Act (``Liquidity Providers''). Market
Street issues unsecured commercial paper with maturities of up to 270
days (``Promissory Notes'') to fund uncommitted purchases of and
uncommitted loans secured by various types of financial assets.
    4. The Promissory Notes issued by Market Street are sold only to
institutional investors that are ``accredited investors'' as defined in
rule 501(a) of Regulation D under the Securities Act of 1933 (the
``Securities Act'') or to ``qualified institutional buyers'' as defined
in rule 144A under the Securities Act. PNC Bank, which has extensive
experience as an administrator of asset-backed commercial paper
programs, will perform the administrative functions for Market Street.
PNC Bank will negotiate the business arrangements on behalf of Market
Street, including loan amounts, interest rates, and fees. PNC Bank will
act as agent for Market Street and the related Liquidity Providers
under the agreements executed with each Borrowing Fund and in such
capacity will exercise rights and enforce remedies on behalf of Market
Street and Liquidity Providers.
    5. As security for a loan, Borrowing Funds will pledge assets
(``Pledged Assets'') for the benefit of Market Street and the
applicable Liquidity Provider. The Pledged Assets will meet eligibility
criteria set by Market Street that will be consistent with the
Borrowing Fund's investment objectives and policies. For each loan
transaction, PNC Bank will evaluate: (a) The type and nature of a
Borrowing Fund's Pledged Assets to determine whether they meet Market
Street's standards for collateral; (b) the operations and history of
the Borrowing Fund; and (c) the financial position and operations of
the Borrowing Fund's investment adviser.
    6. Applicant states that Market Street would make loans to a
Borrowing Fund on an uncommitted basis and the applicable Liquidity
Provider would be obligated to make loans to the Borrowing Fund in the
event Market Street was unable or unwilling to make such loans. Market
Street will have the right in its sole discretion to require the
Liquidity Providers to acquire outstanding loans made by Market Street
to a Borrowing Fund at an agreed-upon amount determined pursuant to the
formula set forth in the related agreements. Applicant states that
these liquidity support arrangements provide additional assurances to
the holders of Promissory Notes that they will be paid at maturity, as
well as protection for Borrowing Funds.
    7. Applicant states that Market Street currently provides financing
for assets originated by customers of PNC Bank and their affiliates as
sellers of those assets to Market Street. The assets purchased by
Market Street include financial assets and securities backed by
financial assets. Some transactions are

structured as loans to the sellers, secured by the assets being
financed, or as agreements to acquire future cash flows from asset
interests. In addition to purchasing interests in pools of assets
directly, Market Street has purchased publicly registered, rule 144A
eligible or privately placed asset-backed securities in open market or
privately negotiated transactions. Market Street finances its purchase
of asset pools primarily through the issuance of its Promissory Notes.
All loans made by Market Street to the Borrowing Funds are not expected
to be in the aggregate more than 20% of Market Street's outstanding
loans and other assets.
    8. Applicant represents that the revolving credit and security
agreement of a Loan Facility, which will be negotiated by the parties,
will contain representations, warranties, covenants and events of
default that are customary for secured loan transactions involving
registered open-end management investment companies, as well as such
other terms that are specific to a particular Borrowing Fund and the
conduct of its business. A Borrowing Fund will have the right at any
time to prepay any outstanding loans under its Loan Facility on certain
monthly or quarterly dates without any premium or penalty. The Pledged
Assets of a Borrowing Fund will be available solely to secure the
repayment of the loans and other outstanding obligations of that
Borrowing Fund under the Loan Facility. Applicant further states that a
Borrowing Fund would have the same rights and remedies under state and
federal law with respect to a Loan Facility from Market Street that it
would have with respect to a comparable loan from a bank. PNC Bank also
states that the arrangements with the Liquidity Providers protect
Borrowing Funds by providing an alternative source of financing in the
event Market Street is unable to continue lending funds.
    9. Before a Loan Facility is established, a Borrowing Fund must
represent, in writing, to PNC Bank, Market Street and the Liquidity
Providers that: (a) Its policies permit borrowing and, if applicable,
the use of leverage; (b) all borrowing transactions pursuant to the
Loan Facility will be subject to the requirements of the Act, the rules
and regulations thereunder, and any other applicable interpretations or
guidance from the Commission or its staff; and (c) each borrowing
transaction will be conducted in accordance with all applicable
representations and conditions of the application. Before a Borrowing
Fund may participate in a Loan Facility, its board of directors or
trustees (``Board''), including a majority of the directors or trustees
that are not ``interested persons'' within the meaning of section
2(a)(19) of the Act (``Disinterested Directors''), will determine that
its participation is consistent with the Borrowing Fund's investment
objectives and policies and in the best interests of the Borrowing Fund
and its shareholders. Each Borrowing Fund's Board, including a majority
of the Disinterested Directors, will also adopt procedures for
evaluating and making certain determinations concerning the terms of
each loan transaction between the Borrowing Fund and Market Street.
    10. PNC Bank states that the proposed Loan Facilities would enable
Borrowing Funds to borrow money from Market Street at lower cost than
obtaining comparable loans from a bank. PNC Bank states that Market
Street's cost of funds is lower than that of banks, and this advantage
will be passed on to the Borrowing Funds.\1\
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    \1\ The rate at which a Liquidity Provider would make a loan to
a Borrowing Fund would not be as favorable as that of Market Street,
but would be comparable to the rates on secured lines of credit from
banks. PNC Bank anticipates that Market Street, rather than a
Liquidity Provider, will be the lender to the Borrowing Funds under
a Loan Facility, absent extenuating circumstances.
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Applicant's Legal Analysis

    1. Section 18(f)(1) of the Act prohibits an open-end investment
company from issuing any senior security except that a company is
permitted to borrow from any bank, if immediately after the borrowing,
there is an asset coverage of at least 300% for all borrowings of the
company.\2\ Section 2(a)(5) defines ``bank'' as a depository
institution, a branch or agency of a foreign bank, a member bank of the
Federal Reserve System, a banking institution or other trust company
that, as a substantial portion of its business, receives deposits or
exercises fiduciary powers similar to those permitted to national
banks. Applicant states that while Market Street engages in many of the
same business activities as banks, it is not a ``bank'' under this
definition.
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    \2\ Under section 18(g) of the Act, the term ``senior security''
includes any bond, debenture, note, or similar obligation or
instrument constituting a security and evidencing indebtedness.
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    2. Section 6(c) of the Act permits the Commission to exempt any
person or transaction or any class or classes of persons or
transactions from any provision or provisions of the Act, if and to the
extent that such exemption is necessary or appropriate in the public
interest and consistent with the protection of investors and the
purposes fairly intended by the policy and provisions of the Act. PNC
Bank requests exemptive relief from section 18(f)(1) solely to the
extent necessary to allow a Borrowing Fund to borrow from Market
Street. PNC Bank believes that permitting the Borrowing Funds to borrow
from Market Street is fully consistent with the purposes and policies
of section 18(f)(1) and would not implicate the concerns underlying
that provision.
    3. PNC Bank states that section 18(f) of the Act reflects
Congressional concern about excessive borrowing and the issuance of
senior securities by open-end investment companies because these
practices could unduly increase the speculative character and
investment risk of junior securities. PNC Bank notes that Borrowing
Funds would remain subject to the 300% asset coverage requirement in
section 18(f)(1) of the Act for all borrowings, including those from
Market Street. PNC Bank further represents that Market Street's loans
will not impose any restrictions on a Borrowing Fund's shareholders
that are different from those imposed by a collateralized bank loan.
Finally, PNC Bank argues that permitting a Borrowing Fund to borrow
from Market Street rather than a bank is expected to reduce its costs
of borrowing, which should decrease the risk that a Borrowing Fund's
borrowing costs will exceed the return from securities purchased with
borrowed money and lessen any related incentive to purchase more
speculative portfolio securities to cover those costs.
    4. PNC Bank states that section 18(f) of the Act also limited open-
end investment companies to borrowing from traditional institutional
lending sources out of a Congressional concern that public holders of
senior securities might be unaware that they were much riskier
instruments than senior securities issued by operating companies.
Senior securities of investment companies typically were secured by
assets that were subject to wide fluctuations in value. Further, common
shareholders could redeem at any time, which also might affect an open-
end investment company's ability to repay its outstanding debt.
    5. PNC Bank argues that the Loan Facilities do not involve the type
of senior security holder that section 18(f)(1) of the Act was designed
to protect and that the structure of the Loan Facilities and Market
Street provide sufficient protection to the parties that face any risk
of loss by lending to an open-end investment company. Market Street is
administered by PNC Bank, which applicant states has expertise in
administering loans collateralized by financial instruments that equals
or exceeds the expertise of

most banks. The Liquidity Providers are banks as defined by the Act and
thus not the type of potential senior security holder that Congress
believed needed protection. PNC Bank states that the Promissory Notes
are general obligations of Market Street and loans to Borrowing Funds
are not expected to exceed 20% of Market Street's outstanding assets
and loans to any individual Borrowing Fund are not expected to exceed
10% of Market Street's assets. Any risk of loss on the Promissory Notes
posed by loans to registered open-end investment companies is further
reduced by PNC Bank's expertise, Market Street's ability to sell the
loans under the Loan Facilities to the Liquidity Providers, Market
Street's external liquidity and credit enhancement sources and the
capital of Market Street.
    6. Applicant states that section 18(f) also reflects a concern that
complex capital structures may permit insiders to manipulate the
allocation of expenses and profits; facilitate control of the
investment company by junior security shareholders with little
investment; and make it difficult for investors in the investment
company to understand what their stock is worth. PNC Bank states that
borrowing from Market Street would not facilitate pyramiding of control
or manipulative reallocation of expenses and profits. Further, PNC Bank
believes that borrowings from Market Street would not be any more
difficult for shareholders of a Borrowing Fund to understand than bank
borrowings.
    7. Applicant also states that section 18(f) reflects a concern that
existed when the Act was adopted that borrowings by open-end investment
companies could be used to invest in securities without being subject
to limitations of the Board of Governors of the Federal Reserve System
(the ``FRB'') on the amount of credit that could be used for these
purposes (``margin requirements''). Under Regulations U and T under the
Securities Exchange Act of 1934, in effect prior to enactment of the
Act, only borrowings for such purposes made by a domestic bank or
broker-dealer were subject to margin requirements. Regulation U as
currently in effect imposes restrictions on banks and lenders other
than broker-dealers that extend credit to borrowers for the purpose of
purchasing or carrying margin stock. If Market Street makes loans to a
Borrowing Fund in excess of the threshold amounts under Regulation U,
Market Street will register with the FRB as a nonbank lender and would
be subject to the same credit restrictions as a bank under Regulation
U.
    8. Finally, applicant believes the requested relief will benefit
Borrowing Funds by providing them with an alternative, lower-cost
source of financing. For all of these reasons and in light of the
protections afforded by the conditions set forth below, PNC Bank
believes that permitting Borrowing Funds to borrow from Market Street
would be in the best interests of the Borrowing Funds and their
shareholders, appropriate in the public interest and consistent with
the protection of investors and the purposes fairly intended by the
policy and provisions of the Act.

Applicant's Conditions

    The applicant agrees that any order granting the requested relief
will be subject to the following conditions:
    1. All Borrowing Funds will comply with the asset coverage
requirements in section 18(f)(1) of the Act, including with respect to
all borrowings from Market Street.
    2. A loan by Market Street to a Borrowing Fund will be at an
interest rate equal to Market Street's cost of funds (i.e., the
weighted average Promissory Note rate plus dealer commissions).
    3. Before a Borrowing Fund may participate in a Loan Facility, the
Borrowing Fund's Board, including a majority of the Disinterested
Directors, will determine that participation in the Loan Facility is
consistent with the Borrowing Fund's investment objectives and policies
and is in the best interests of the Borrowing Fund and its
shareholders. In addition, a Borrowing Fund will disclose in its
statement of additional information all material facts about its
participation in the Loan Facility.
    4. Before a Borrowing Fund may participate in a Loan Facility, its
Board, including a majority of the Disinterested Directors, will adopt
procedures governing the Borrowing Fund's participation in the Loan
Facility (``Procedures''). In addition to any other provisions the
Board may find necessary or appropriate to be included in the
Procedures, the Procedures will require that, before a Borrowing Fund
may enter into loan transactions with Market Street, the Board,
including a majority of the Disinterested Directors, will determine
that:
    a. The borrowing is in the best interests of the Borrowing Fund and
its shareholders;
    b. The borrowing and pledge of assets are consistent with the
Borrowing Fund's investment objectives and policies;
    c. The total anticipated cost of the Loan Facility (including fees
and interest) does not exceed the total anticipated costs of comparable
financing alternatives that are available to the Borrowing Fund;
    d. The asset eligibility criteria for the Loan Facility are
consistent with the Borrowing Fund's investment objectives and
policies; and
    e. The Borrowing Fund's investments, consistent with the asset
eligibility criteria and any other requirements of participating in the
Loan Facility, will be in the best interests of the Borrowing Fund and
its shareholders.
    5. If Market Street determines (a) to require the Liquidity
Providers to acquire from Market Street outstanding loans made to a
Borrowing Fund, or (b) not to extend additional loans to a Borrowing
Fund, the Board of the Borrowing Fund, including a majority of the
Disinterested Directors, will be notified promptly. As soon as
practicable, the Board, including a majority of the Disinterested
Directors, must determine whether it is in the best interests of the
Borrowing Fund and its shareholders to continue to participate in the
Loan Facility or to terminate the Borrowing Fund's participation in the
Loan Facility in accordance with its terms.
    6. At each regular quarterly meeting, the Board, including a
majority of the Disinterested Directors, will (a) review a Borrowing
Fund's loan transactions under its Loan Facility during the preceding
quarter, including the terms of each transaction, and (b) determine
whether the transactions were effected in compliance with the
Procedures and the terms and conditions of the order. At least
annually, the Board, including a majority of the Disinterested
Directors, will (a) with respect to a Borrowing Fund's continued
participation in a Loan Facility, make the determinations required in
condition 3 above, and (b) approve such changes to the Procedures as it
deems necessary or appropriate.
    7. A Borrowing Fund will maintain and preserve permanently in an
easily accessible place a written copy of the Procedures and any
modifications to the Procedures. The Borrowing Fund will maintain and
preserve for a period of not less than six years from the end of the
fiscal year in which any transaction with a Loan Facility occurred, the
first two years in an easily accessible place, a written record of each
transaction setting forth a description of the terms of the
transaction, including the amount, maturity, and the rate of interest
on the loan, and all information upon which the determinations required
by these conditions were made.
    8. The applicant will not enter into a Loan Facility with any
Borrowing Fund if, at the time of such transaction, the

applicant, Market Street or any Liquidity Provider is an affiliated
person of that Borrowing Fund, within the meaning of section 2(a)(3) of
the Act, or an affiliated person of any affiliated person of that
Borrowing Fund.

Florence E. Harmon,
Deputy Secretary.
[FR Doc. E9-29321 Filed 12-8-09; 8:45 am]

BILLING CODE 8011-01-P