[Federal Register Volume 75, Number 246 (Thursday, December 23, 2010)]
[Notices]
[Pages 80865-80866]
[FR Doc No: 2010-32287]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. IC-29541]

Notice of Applications for Deregistration Under Section 8(f) of
the Investment Company Act of 1940

December 16, 2010.

    The following is a notice of applications for deregistration under
section 8(f) of the Investment Company Act of 1940 for the month of
December 2010. A copy of each 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>. An order granting each application will be
issued unless the SEC orders a hearing. Interested persons may request
a hearing on any application by writing to the SEC's Secretary at the
address below and serving the relevant applicant with a copy of the
request, personally or by mail. Hearing requests should be received by
the SEC by 5:30 p.m. on January 11, 2011, and should be accompanied by
proof of service on the applicant, 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 Secretary, U.S. Securities and
Exchange Commission, 100 F Street, NE., Washington, DC 20549-1090.

FOR FURTHER INFORMATION CONTACT: Diane L. Titus at<PHONE_NUMBER>, SEC,
Division of Investment Management, Office of Investment Company
Regulation, 100 F Street, NE., Washington, DC 20549-4041.

New Providence Investment Trust [File No. 811-8295]

    Summary: Applicant seeks an order declaring that it has ceased to
be an investment company. On February 18, 2010, applicant transferred
its assets to The Jacob Wisdom Fund, a series of Jacob Funds Inc.,
based on net asset value. Expenses of approximately $81,630 incurred in
connection with the reorganization were paid by Atlanta Investment
Counsel, LLC and Jacob Asset Management of New York, LLC, applicant's
investment advisers.
    Filing Dates: The application was filed on September 30, 2010, and
amended on December 1, 2010.
    Applicant's Address: 116 S. Franklin St., Rocky Mount, NC 27804.

AARP Funds [File No. 811-21825]

AARP Portfolios [File No. 811-21839]

    Summary: Each applicant seeks an order declaring that it has ceased
to be an investment company. On September 29, 2010, each applicant made
a liquidating distribution to its shareholders, based on net asset
value. Expenses of $44,000 and $38,500, respectively, incurred in
connection with the liquidations were paid by applicants and AARP
Financial Inc., applicants' investment adviser. Each applicant has less
than $1,000 in miscellaneous outstanding expenses which will be paid by
AARP Financial Inc. or its affiliates.
    Filing Date: The applications were filed on December 6, 2010.
    Applicants' Address: 650 F St., NW., 2nd Floor, Washington, DC
20004.

Investment Grade Municipal Income Fund Inc. [File No. 811-7096]

    Summary: Applicant, a closed-end investment company, seeks an order
declaring that it has ceased to be an investment company. Between April
16, 2010 and April 20, 2010, applicant's outstanding auction preferred
shares were redeemed in full, with each preferred shareholder receiving
the liquidation preference of $50,000 per share plus any accumulated
but unpaid dividends. On May 10, 2010, applicant made a liquidating
distribution to its common shareholders, based on net asset value.
Expenses of $263,000 incurred in connection with the liquidation were
paid by applicant.
    Filing Date: The application was filed on November 15, 2010.
    Applicant's Address: 1285 Avenue of the Americas, 12th Floor, New
York, NY 10019-6028.

BBH Asian Opportunity Registered Fund, LLC [File No. 811-22200]

    Summary: Applicant, a closed-end investment company, seeks an order
declaring that it has ceased to be an investment company. Applicant has
never made a public offering of its securities and does not propose to
make a public offering or engage in business of any kind.
    Filing Date: The application was filed on November 23, 2010.
    Applicant's Address: 140 Broadway, New York, NY 10005.

UM Investment Trust [File No. 811-21044]

    Summary: Applicant, a closed-end investment company, seeks an order
declaring that it has ceased to be an investment company. Applicant has
never made a public offering of its securities and does not propose to
make a public offering or engage in any business activities other than
those necessary for winding up its affairs.
    Filing Dates: The application was filed on October 21, 2010, and
amended on December 3, 2010.
    Applicant's Address: 245 Park Ave., New York, NY 10167.

Morgan Stanley Opportunistic Municipal High Income Fund [File No. 811-
21857]

    Summary: Applicant, a closed-end investment company, seeks an order
declaring that it has ceased to be an investment company. Applicant has
never made a public offering of its securities and does not propose to
make a public offering or engage in business of any kind.
    Filing Dates: The application was filed on September 30, 2010, and
amended on December 3, 2010.
    Applicant's Address: 522 Fifth Ave., New York, NY 10036.

BlackRock Core Alternatives Portfolio LLC [File No. 811-22254]

BlackRock Core Alternatives TEI Portfolio LLC [File No. 811-22364]

BlackRock Core Alternatives FB Portfolio LLC [File No. 811-22365]

BlackRock Core Alternatives FB TEI Portfolio LLC [File No. 811-22366]

    Summary: Each applicant, a closed-end investment company, seeks an
order declaring that it has ceased to be an investment company.
Applicants have never made a public offering of their securities and do
not propose to make a public offering or engage in business of any
kind.
    Filing Date: The applications were filed on December 8, 2010.
    Applicants' Address: 100 Bellevue Parkway, Wilmington, DE 19809.

Oppenheimer Principal Protected Trust [File No. 811-21281]

    Summary: Applicant seeks an order declaring that it has ceased to
be an investment company. On August 26, 2010, applicant transferred its
assets to Oppenheimer Main Street Funds, Inc., based on net asset
value. Expenses of approximately $74,707 incurred in

connection with the reorganization were paid by applicant.
    Filing Date: The application was filed on December 2, 2010.
    Applicant's Address: OppenheimerFunds, Inc., 6803 S. Tucson Way,
Centennial, CO 80112.

BlackRock California Investment Quality Municipal Trust Inc. [File No.
811-7664]

    Summary: Applicant, a closed-end investment company, seeks an order
declaring that it has ceased to be an investment company. By September
30, 2010, applicant had redeemed all of its Series W7 Preferred Shares
at their liquidation preference plus any accrued but unpaid dividends.
On September 30, 2010, applicant made a liquidating distribution to its
common shareholders, based on net asset value. Expenses of $25,025
incurred in connection with the liquidation were paid by applicant.
Applicant has retained approximately $100,000 in cash to pay any
contingent liabilities recognized after the liquidation date.
    Filing Dates: The application was filed on October 5, 2010 and
amended on December 6, 2010.
    Applicant's Address: 100 Bellevue Parkway, Wilmington, DE 19809.

T. Rowe Price Tax-Free Intermediate Bond Fund, Inc. [File No. 811-7051]

    Summary: Applicant seeks an order declaring that it has ceased to
be an investment company. On November 13, 2006, applicant transferred
its assets to T. Rowe Price Summit Municipal Funds, Inc., based on net
asset value. Expenses of approximately $17,940 incurred in connection
with the reorganization were paid by applicant, the acquiring fund and
T. Rowe Price Associates, Inc., applicant's investment adviser.
    Filing Dates: The application was filed on June 26, 2009, and
amended on December 2, 2010.
    Applicant's Address: 100 E. Pratt St., Baltimore, MD 21202.

AFBA 5Star Funds [File No. 811-8035]

    Summary: Applicant seeks an order declaring that it has ceased to
be an investment company. On March 12, 2010, applicant transferred its
assets to corresponding series of FBR Funds, based on net asset value.
Expenses of $94,946 incurred in connection with the reorganization were
paid by AFBA Investment Management Company, applicant's investment
adviser, and FBR Fund Advisers, Inc., investment adviser to the
acquiring fund.
    Filing Dates: The application was filed on September 22, 2010, and
amended on December 14, 2010.
    Applicant's Address: 909 N. Washington St., Alexandria, VA 22314.

Liquid Institutional Reserves [File No. 811-6281]

    Summary: Applicant seeks an order declaring that it has ceased to
be an investment company. On April 22, 2004, applicant made a
liquidating distribution to its shareholders, based on net asset value.
Expenses of $6,560 incurred in connection with the liquidation were
paid by UBS Global Asset Management (Americas) Inc., an affiliate of
applicant's investment adviser.
    Filing Date: The application was filed on December 9, 2010.
    Applicant's Address: c/o UBS Global Asset Management, Attn: Keith
A. Weller, 1285 Avenue of the Americas, 12th Floor, New York, NY 10019.

    For the Commission, by the Division of Investment Management,
pursuant to delegated authority.
Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-32287 Filed 12-22-10; 8:45 am]
BILLING CODE 8011-01-P


     UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460

                             OFFICE OF CHEMICAL SAFETY
AND POLLUTION PREVENTION
MEMORANDUM FOR THE RECORD

RE:  	Meeting with Boeing on the Regulation of Persistent, Bioaccumulative, and Toxic Chemicals Under TSCA Section 6(h)
List of Contents
 Meeting Summary
 Attendees

Meeting Summary

On August 3, 2022, representatives from EPA met with Boeing to discuss comments submitted in docket EPA-HQ-OPPT-2021-0598 on the Regulation of Persistent, Bioaccumulative, and Toxic Chemicals Under TSCA Section 6(h); Phenol, Isopropylated Phosphate (3:1); Compliance Date Extension, published March 8, 2022. During the meeting, Boeing gave an overview of their concerns regarding the upcoming compliance deadline for the for processing and distribution in commerce and the associated recordkeeping requirements for PIP (3:1) in certain articles, and in particular in articles that are used in new and replacement parts for aerospace vehicles. In discussing articles that contain PIP (3:1), Boeing emphasized the difficulty in identifying the exact parts that contain the chemical, and the difficulty in transitioning to an alternative for certain high safety rated uses. Boeing also provided further information on the testing, qualification, and manufacturing process and timelines for new and replacement parts for aerospace vehicles. Additionally, Boeing presented information on their use of PIP (3:1) in aviation hydraulic fluids, and in lubricants and greases, noting that these continue to be critical uses without easily available alternatives. EPA gave an overview of the TSCA section 6(h) rulemaking activities to date. Boeing indicated they would continue engaging with the EPA rulemaking process.

Attendees
EPA:
Niva Kramek
Cindy Wheeler
Gabriela Rossner

Boeing:
Peter Pagano
Carolyn Kupper
Sturla Olsen
Dario Gomez


[Federal Register: September 22, 2006 (Volume 71, Number 184)]
[Notices]
[Page 55527-55530]
[DOCID:fr22se06-157]

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SECURITIES AND EXCHANGE COMMISSION

[Investment Company Act Release No. 27484; 812-13171]

Claymore Securities, Inc. and Claymore Securities Defined
Portfolios, Notice of Application

September 18, 2006.
AGENCY: Securities and Exchange Commission (``Commission'').

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

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SUMMARY OF THE APPLICATION: Claymore Securities, Inc. (the
``Depositor''), and Claymore Securities Defined Portfolios (the
``Trust''), on behalf of itself and any existing and future series, and
any future registered unit investment trust (``UIT'') sponsored by the
Depositor (or an entity controlling, controlled by or under common
control with the Depositor) and their respective series (the future
UITs, together with the Trust, are collectively the ``Trusts,'' the
series of the Trusts are the ``Series,'' and the Trusts together with
the Depositor are collectively, the (``Applicants''), request an order
to permit each Series to acquire shares of registered investment
companies or series thereof (the ``Funds'') both within and outside the
same group of investment companies.

APPLICANTS: The Depositor and the Trust.

FILING DATES: The application was filed on February 23, 2005 and
amended on June 28, 2006 and September 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 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 24, 2006 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, U.S. Securities and Exchange Commission, 100 F
Street, NE., Washington, DC 20549-10901; Applicants, 2455 Corporate
West Drive, Lisle, Illinois 60532.

FOR FURTHER INFORMATION CONTACT: Deepak T. Pai, Senior Counsel, at
(202) 551-6876, or Nadya Roytblat, Assistant Director 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 for a fee at the
Public Reference Desk, U.S. Securities and Exchange Commission, 100 F
Street, NE., Washington DC 20549-0102, tel:<PHONE_NUMBER>.

Applicants' Representations

    1. The Trust is a UIT registered under the Act. Each Series will be
a series of a Trust and will offer units for sale to

the public (``Units'').\1\ Each Series will be created pursuant to a
trust agreement which will incorporate by reference a master trust
agreement between the Depositor and a financial institution that
satisfies the criteria in section 26(a) of the Act (the ``Trustee'').
The Depositor is a broker dealer registered under the Securities
Exchange Act of 1934 and member of the National Association of
Securities Dealers, Inc. (``NASD'').
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    \1\ All existing Trusts that currently intend to rely on the
requested order are named as applicants. Any other Trust that relies
on the order in the future will comply with the terms and conditions
of the application.
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    2. Applicants request relief to permit a Series to invest in (a)
registered investment companies or series thereof that are part of the
same ``group of investment companies'' (as that term is defined in
section 12(d)(1)(G) of the Act) as the Series (``Affiliated Funds''),
and (b) registered investment companies or series thereof that are not
part of the same group of investment companies as the Series
(``Unaffiliated Funds,'' and together with the Affiliated Funds, the
``Funds''). An Unaffiliated Fund that is a UIT is referred to as an
``Unaffiliated Underlying Trust.'' An Unaffiliated Fund that is a
closed-end or open-end management investment company is referred to as
an ``Unaffiliated Underlying Fund''. Certain of the Funds may be
``exchange-traded funds'' that are registered under the Act as UITs or
open-end management investment companies and have received exemptive
relief to sell their shares on a national securities exchange or at
negotiated prices (``ETFs''). Shares of closed-end Funds and ETFs will
be deposited in a Series at prices which are based on the market value
of the securities, as determined by an evaluator. The Depositor will
not have discretion as to when portfolio securities of a Series will be
sold, except that the Depositor is authorized to sell securities in
extremely limited circumstances described in the Series' prospectus.
    3. Applicants state that the requested relief will benefit the
holders of Units of a Series by providing investors with a
professionally selected, diversified portfolio of registered investment
company shares through a single investment vehicle.

Applicants' Legal Analysis

A. Section 12(d)(1) of the Act

    1. Section 12(d)(1)(A) of the Act prohibits a registered investment
company from acquiring shares of an investment company if the
securities represent (i) more than 3% of the total outstanding voting
stock of the acquired company (ii) more than 5% of the total assets of
the acquiring company, or (iii) together with the securities of any
other investment companies, more than 10% of the total assets of the
acquiring company. Section 12(d)(1)(B) of the Act prohibits a
registered open-end investment company, its principal underwriter, and
any broker or dealer from selling shares of the investment company to
another investment company if the sale will cause (i) the acquiring
company to own more than 3% of the acquired company's voting stock, or
(ii) more than 10% of the acquired company's voting stock to be owned
by investment companies. Section 12(d)(1)(C) prohibits an investment
company, other investment companies having the same investment adviser,
and companies controlled by such investment companies, from acquiring
more than 10% of the outstanding voting stock of a registered closed-
end management investment company.
    2. Section 12(d)(1)(G) provides, in relevant part, that section
12(d)(1) will not apply to securities of a registered open-end
investment company or UIT acquired by a registered UIT if the acquired
company and the acquiring company are part of the same group of
investment companies, provided that certain other requirements
contained in section 12(d)(1)(G) are met. Applicants state that they
may not rely on section 12(d)(1)(G) because a Series will invest in
Unaffiliated Funds and other securities in addition to Affiliated
Funds.
    3. Section 12(d)(1)(J) of the Act provides that the Commission may
exempt any person, security, or transaction, or any class or classes of
persons, securities or transactions, from any provision of section
12(d)(1) if the exemption is consistent with the public interest and
the protection of investors. Applicants seek an exemption under section
12(d)(1)(J) to permit a Series to acquire shares of a Fund and to
permit a Fund to sell its shares to a Series beyond the limits set
forth in sections 12(d)(1)(A), (B), and (C).
    4. Applicants state that the proposed arrangement will not give
rise to the policy concerns underlying sections 12(d)(1)(A), (B), and
(C), which include concerns about undue influence by a fund of funds
over underlying funds, excessive layering of fees, and overly complex
fund structures. Accordingly, applicants believe that the requested
exemption is consistent with the public interest and the protection of
investors.
    5. Applicants state that the concern about undue control does not
arise with respect to a Series' investment in Affiliated Funds, as
reflected in section 12(d)(1)(G) of the Act. Applicants also state that
the proposed arrangement will not result in undue influence by a Series
or its affiliates over Unaffiliated Funds. Applicants have agreed that
(a) the Depositor, (b) any person controlling, controlled by or under
common control with the Depositor, and (c) any investment company and
any issuer that would be an investment company but for section 3(c)(1)
or 3(c)(7) of the Act, sponsored or advised by the Depositor (or any
person controlling, controlled by or under common control with the
Depositor) (collectively, the ``Group'') will not control (individually
or in the aggregate) an Unaffiliated Fund within the meaning section
2(a)(9) of the Act. Applicants also note that conditions 2, 3, 5 and 6
set forth below will address the concern about undue influence with
respect to the Unaffiliated Funds.
    6. As an additional assurance that an Unaffiliated Underlying Fund
understands the implications of an investment by a Series under the
requested order, prior to a Series' investment in the Unaffiliated
Underlying Fund in excess of the limit in Section 12(d)(1)(A)(i), the
Series and the Unaffiliated Underlying Fund will execute an agreement
stating, without limitation, that the Depositor and Trustee and the
board of directors or trustees to the Unaffiliated Underlying Fund and
the investment adviser(s) to the Unaffiliated Underlying Fund,
understand the terms and conditions of the order and agree to fulfill
their responsibilities under the order (``Participation Agreement'').
Applicants note that an Unaffiliated Underlying Fund, including a
closed-end Fund or an ETF, may choose to reject an investment from the
Series by declining to execute the Participation Agreement.
    7. Applicants do not believe that the proposed arrangement will
involve excessive layering of fees. Applicants state that any sales
charges and/or service fees (as those terms are defined in Rule 2830 of
the Conduct Rules of the NASD, Inc. (``NASD Conduct Rules'')) charged
with respect to Units of a Series will not exceed the limits applicable
to a fund of funds as set forth in Rule 2830 of the NASD Conduct
Rules.\2\ In addition, the Trustee or Depositor will waive fees
otherwise payable to it by the Series in an amount at least equal to
any compensation (including fees paid pursuant to any plan adopted by
an

Unaffiliated Underlying Fund under rule 12b-1 under the Act) received
from an Unaffiliated Fund by the Trustee or Depositor, or an affiliated
person of the Trustee or Depositor, other than any advisory fees paid
to the Trustee or Depositor or its affiliated person by an Unaffiliated
Underlying Fund, in connection with the investment by the Series in the
Unaffiliated Fund.
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    \2\ With respect to purchasing closed-end Funds or ETF shares, a
Series may incur the customary brokerage commissions associated with
purchasing any equity security on the secondary market.
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    8. Applicants state that the proposed arrangement will not create
an overly complex fund structure. Applicants note that a Fund will be
prohibited from acquiring securities of any investment company or
company relying on section 3(c)(1) or 3(c)(7) of the Act in excess of
the limits contained in section 12(d)(1)(A). Applicants also represent
that a Series' prospectus and sales literature will contain concise,
``plain English'' disclosure designed to inform investors of the unique
characteristics of the trust of funds structure, including, but not
limited to, its expense structure and the additional expenses of
investing in Funds.\3\
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    \3\ Each Series also will comply with the disclosure
requirements concerning aggregate costs of investing in the Funds
set forth in the Investment Company Act Release No. 27399 by the
compliance date set forth therein.
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B. Section 17(a) of the Act

    1. Section 17(a) of the Act generally prohibits sales or purchases
of securities between a registered investment company and any
affiliated person of the company. Section 2(a)(3) of the Act defines an
``affiliated person'' of another person to include (a) any person
directly or indirectly owning, controlling, or holding with power to
vote, 5% or more of the outstanding voting securities of the other
person; (b) any person 5% or more of whose outstanding voting
securities are directly or indirectly owned, controlled, or held with
power to vote by the other person; and (c) any person directly or
indirectly controlling, controlled by, or under common control with the
other person.
    2. Applicants state that a Series and an Affiliated Fund might be
deemed to be under the common control of the Depositor or an entity
controlling, controlled by, or under common control with the Depositor.
Applicants also state that a Series and a Fund might become
``affiliated persons'' if the Series acquires more than 5% of the
Fund's outstanding voting securities. The sale or redemption by a Fund
of its shares to or from a Series therefore could be deemed to be a
principal transaction prohibited by section 17(a) of the Act.\4\
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    \4\ Applicants note that shares of an ETF would be purchased and
sold generally through secondary market transactions at market
prices rather than through principal transactions with the ETF at
net asset value. Applicants will not rely on the requested relief
from section 17(a) for such secondary market transactions.
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    3. Section 17(b) of the Act authorizes the Commission to grant an
order permitting a transaction otherwise prohibited by section 17(a) if
it finds that (a) the terms of the proposed transaction are fair and
reasonable and do not involve overreaching on the part of any person
concerned; (b) the proposed transaction is consistent with the policies
of each registered investment company involved; and (c) the proposed
transaction is consistent with the general purposes of the Act. Section
6(c) of the Act permits the Commission to exempt any person or
transactions from any provision of 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 policy
and provisions of the Act.
    4. Applicants submit that the proposed transactions satisfy the
standards for relief under sections 17(b) and 6(c) of the Act.
Applicants state that the terms of the proposed transactions are fair
and reasonable and do not involve overreaching. Applicants note that
the consideration paid for the sale and redemption of shares of the
open-end Funds and Funds that are UITs will be based on the net asset
values of the Funds. Further, Applicants state that shares of ETFs and
closed-end Funds will be purchased at market prices. Finally,
Applicants state that the proposed transactions will be consistent with
the policies of each Series and Fund, and with the general purposes of
the Act.

Applicants' Conditions

    Applicants agree that the requested order will be subject to the
following conditions:
    1. The members of the Group will not control (individually or in
the aggregate) an Unaffiliated Fund within the meaning of section
2(a)(9) of the Act. If, as a result of a decrease in the outstanding
voting securities of an Unaffiliated Fund, the Group, in the aggregate,
becomes a holder of more than 25% of the outstanding voting securities
of the Unaffiliated Fund, the Group will vote its shares of the
Unaffiliated Fund in the same proportion as the vote of all other
holders of the Unaffiliated Fund's shares.
    2. No Series or its Depositor, promoter, principal underwriter, or
any person controlling, controlled by, or under common control with any
of those entities (each, a ``Series Affiliate'') will cause any
existing or potential investment by the Series in an Unaffiliated Fund
to influence the terms of any services or transactions between the
Series or Series Affiliate and the Unaffiliated Fund or its investment
adviser(s), sponsor, promoter, principal underwriter, or any person
controlling, controlled by, or under common control with any of those
entities.
    3. Once an investment by a Series in the securities of an
Unaffiliated Underlying Fund exceeds the limit in section
12(d)(1)(A)(i) of the Act, the board of directors or trustees of the
Unaffiliated Underlying Fund, including a majority of the disinterested
board members, will determine that any consideration paid by the
Unaffiliated Underlying Fund to the Series or Series Affiliate in
connection with any services or transactions: (a) Is fair and
reasonable in relation to the nature and quality of the services and
benefits received by the Unaffiliated Underlying Fund; (b) is within
the range of consideration that the Unaffiliated Underlying Fund would
be required to pay to another unaffiliated entity in connection with
the same services or transactions; and (c) does not involve
overreaching on the part of any person concerned. This condition does
not apply with respect to any services or transactions between an
Unaffiliated Underlying Fund and its investment adviser(s), or any
person controlling, controlled by, or under common control with such
investment adviser(s).
    4. The Trustee or Depositor will waive fees otherwise payable to it
by the Series in an amount at least equal to any compensation
(including fees received pursuant to any plan adopted by an
Unaffiliated Underlying Fund under rule 12b-1 under the Act) received
from an Unaffiliated Fund by the Trustee or Depositor, or an affiliated
person of the Trustee or Depositor, other than any advisory fees paid
to the Trustee or Depositor or its affiliated person by an Unaffiliated
Underlying Fund, in connection with the investment by a Series in the
Unaffiliated Fund.
    5. No Series or Series Affiliate (except to the extent it is acting
in its capacity as an investment adviser to an Unaffiliated Underlying
Fund or sponsor to an Unaffiliated Underlying Trust) will cause an
Unaffiliated Fund to purchase a security in an offering of securities
during the existence of any underwriting or selling syndicate of which
a principal underwriter is the Depositor or a person of which the
Depositor is an affiliated person (each, an ``Underwriting Affiliate,''
except any

person whose relationship to the Unaffiliated Fund is covered by
section 10(f) of the Act is not an Underwriting Affiliate). An offering
of securities during the existence of an underwriting or selling
syndicate of which a principal underwriter is an Underwriting Affiliate
is an ``Affiliated Underwriting.''
    6. The board of an Unaffiliated Underlying Fund, including a
majority of the disinterested board members, will adopt procedures
reasonably designed to monitor any purchases of securities by the
Unaffiliated Underlying Fund in an Affiliated Underwriting once an
investment by a Series in the securities of the Unaffiliated Underlying
Fund exceeds the limit of section 12(d)(1)(A)(i) of the Act, including
any purchases made directly from an Underwriting Affiliate. The board
of the Unaffiliated Underlying Fund will review these purchases
periodically, but no less frequently than annually, to determine
whether the purchases were influenced by the investment by the Series
in the Unaffiliated Underlying Fund. The board of the Unaffiliated
Underlying Fund will consider, among other things: (a) Whether the
purchases were consistent with the investment objectives and policies
of the Unaffiliated Underlying Fund; (b) how the performance of
securities purchased in an Affiliated Underwriting compares to the
performance of comparable securities purchased during a comparable
period of time in underwritings other than Affiliated Underwritings or
to a benchmark such as a comparable market index; and (c) whether the
amount of securities purchased by the Unaffiliated Underlying Fund in
Affiliated Underwritings and the amount purchased directly from an
Underwriting Affiliate have changed significantly from prior years. The
board of the Unaffiliated Underlying Fund will take any appropriate
actions based on its review, including, if appropriate, the institution
of procedures designed to assure that purchases of securities in
Affiliated Underwritings are in the best interests of shareholders.
    7. An Unaffiliated Underlying Fund will maintain and preserve
permanently in an easily accessible place a written copy of the
procedures described in the preceding condition, and any modifications
to such procedures, and will maintain and preserve for a period of not
less than six years from the end of the fiscal year in which any
purchase in an Affiliated Underwriting occurred, the first two years in
an easily accessible place, a written record of each purchase of
securities in Affiliated Underwritings once an investment by a Series
in the securities of the Unaffiliated Underlying Fund exceeds the limit
of section 12(d)(1)(A)(i) of the Act, setting forth from whom the
securities were acquired, the identity of the underwriting syndicate's
members, the terms of the purchase, and the information or materials
upon which the determinations of the board of the Unaffiliated
Underlying Fund were made.
    8. Before investing in an Unaffiliated Underlying Fund in excess of
the limit in section 12(d)(1)(A)(i), each Series and the Unaffiliated
Underlying Fund will execute a Participation Agreement stating, without
limitation, that the Depositor and Trustee and the board of directors
or trustees of the Unaffiliated Underlying Fund and the investment
adviser(s) to the Unaffiliated Underlying Fund, understand the terms
and conditions of the order and agree to fulfill their responsibilities
under the order. At the time of its investment in shares of an
Unaffiliated Underlying Fund in excess of the limit in section
12(d)(1)(A)(i), a Series will notify the Unaffiliated Underlying Fund
of the investment. At such time, the Series also will transmit to the
Unaffiliated Underlying Fund a list of the names of each Series
Affiliate and Underwriting Affiliate. The Series will notify the
Unaffiliated Underlying Fund of any changes to the list of names as
soon as reasonably practicable after a change occurs. The Unaffiliated
Underlying Fund and the Series will maintain and preserve a copy of the
order, the Participation Agreement, and the list with any updated
information for the duration of the investment, and for a period of not
less than six years thereafter, the first two years in an easily
accessible place.
    9. Any sales charges and/or service fees charged with respect to
Units of a Series will not exceed the limits applicable to a fund of
funds as set forth in Rule 2830 of the Conduct Rules of the NASD.
    10. No Fund will acquire securities of any investment company or
company relying on section 3(c)(1) or 3(c)(7) of the Act in excess of
the limits contained in section 12(d)(1)(A) of the Act.

    For the Commission, by the Division of Investment Management,
pursuant to delegated authority.
Jill M. Peterson,
Assistant Secretary.
[FR Doc. 06-7998 Filed 9-21-06; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register: April 29, 2009 (Volume 74, Number 81)]
[Notices]
[Page 19623-19624]
[DOCID:fr29ap09-151]

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DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

[Docket: PHMSA-2009-0057]

Pipeline Safety: Agency Information Collection Activities: Notice
of Request for Extension of Currently Approved Information Collections

AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA),
U.S. Department of Transportation (DOT).

ACTION: Notice and request for comments.

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

SUMMARY: In compliance with the Paperwork Reduction Act of 1995 (PRA),
this notice announces that the Information Collection Requests (ICRs)
abstracted below will be forwarded to the Office of Management and
Budget (OMB) for review and comments. The ICRs describe the nature of
the information collections and their expected burden. A Federal
Register Notice with a 60-day comment period soliciting comments on
ICRs was published in the Federal Register on February 20, 2009 (73 FR
7955) under Docket No. PHMSA-2009-0057. Two comments were received. The
purpose of this notice is to allow the public an additional 30 days to
submit comments on the information collections described below and
respond to comments submitted to the 60-day notice.

DATES: Interested persons are invited to submit comments on or before
May 29, 2009.

ADDRESSES: Send comments directly to the Office of Management and
Budget, Office of Information and Regulatory Affairs, Attn: Desk
Officer for the Department of Transportation, 725 17th Street, NW.,
Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT: Cameron Satterthwaite at (202) 366-
1319, or by e-mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Section 1320.8(d), Title 5, Code of Federal
Regulations requires Federal agencies to provide interested members of
the public and affected agencies an opportunity to comment on
information collection and recordkeeping requests. This notice
identifies information collection requests that PHMSA will be
submitting to OMB for renewal and extension. These information
collections are contained in the pipeline safety regulations, 49 CFR
parts 190-199.
    PHMSA received two comments on information collection OMB Control
No. 2137-0610, entitled ``Pipeline Integrity Management in High
Consequence Areas Gas Transmission Pipeline Operators,'' from Southwest
Gas Corporation (Southwest) and Paiute Pipeline Company (Paiute).
Southwest and Paiute both commented that the burden hour estimate was
low and further requested PHMSA to convene a workshop to explore the
burden hours estimate, including improvements that could be made. PHMSA
will consider these comments and make efforts to pursue methods of
addressing Southwest's and Paiute's concerns prior to the next renewal
period. However, at this time PHMSA is forwarding this information
collection request to OMB as this information collection will expire
May 31, 2009.
    PHMSA has revised burden estimates, where appropriate, to reflect
current reporting levels or adjustments based on changes in proposed or
final rules published since the information collections were last
approved. The following information is provided for each information
collection: (1) Title of the information collection; (2) OMB control
number; (3) type of request; (4) abstract of the information collection
activity; (5) description of affected public; (6) estimate of total
annual reporting and recordkeeping burden; and (7) frequency of
collection. PHMSA will request a three-year term of approval for each
information collection activity.
    PHMSA requests comments on the following information collections:
    Title: Pipeline Safety: Response Plans for Onshore Oil Pipelines.
    OMB Control Number: 2137-0589.
    Type of Request: Renewal of a currently approved information
collection.
    Abstract: 49 CFR part 194 requires an operator of an onshore oil
pipeline facility to prepare and submit an oil spill response plan to
PHMSA for review and approval.
    Estimated number of respondents: 367.
    Estimated annual burden hours: 50,186 hours.
    Frequency of collection: On occasion.

    Title: Pipeline Safety: Pipeline Integrity Management in High
Consequence Areas Gas Transmission Pipeline Operators.

    OMB Control Number: 2137-0610.
    Type of Request: Renewal of a currently approved information
collection.
    Abstract: 49 CFR 192.947 requires operators of gas transmission
pipelines located in or near high consequence areas to maintain a
written integrity management program and records showing compliance
with 49 CFR part 192, subpart O. In addition, operators must submit
documentation relative to their integrity management program to PHMSA
as applicable.
    Estimated number of respondents: 721.
    Estimated annual burden hours: 1,030,343 hours.
    Frequency of collection: On occasion.

    Issued in Washington, DC, on April 23, 2009.
John A. Gale,
Director of Regulations, Office of Pipeline Safety.
[FR Doc. E9-9775 Filed 4-28-09; 8:45 am]

BILLING CODE 4910-60-P


MEMORANDUM:

May 25, 2005 SUBJECT: Envivornmental Fate Assessment of Nuesept 95 ( Azadioxabicyclooctane) for the Reregistration Eligibility Decision ( RED) Process From: A. Najm Chamim, Ph. D., Chemist Regulatory Management Branch II Antimimicrobials Division ( 7510C)

To: Ben Chambliss, Team Leader Regulatory Management Branch II Antimicrobials Division ( 7510C)

And Kathryn Montague, Science Coordinator for Aza RED Risk Assessment and Science Support Branch Antimicrobials Division ( 7510C)

Thru: Mark Hartman, Chief Regulatory Management Branch II Antimicrobials Division ( 7510C)

Enclosed is the Environmental Fate Science Chapter on the Risk Assessment for Azadioxabicyclooctane RED.

DP Barcode: PC Codes: 10701, 10702, and 10703 CAS#: ENVIRONMENTAL FATE AND TRANSPORT ASSESSMENT FOR: AZADIOXABICYCYCLOOCTANE EXECUTIVE SUMMARY:

The Agency database for risk assessment of Azadioxabicyclooctane ( mixture of three components) is incomplete as only abiotic aqueous hydrolysis study is available for this pesticide. However, for the present risk assessment, we have used Agency's EPISuite Program, which is an estimation program of physical and chemical characteristics as well as some fate and transport parameters of chemicals. This possibly will give a conservative fate assessment of azadioxabicyclooctane.

Azadioxabicyclooctane ( is a mixture of three acetals: 5 hydroxymethoxymethyl 1 aza 3,7 dioxabicyclo( 3.3.0) octane ( 28.8%), ( component A) 5 hydroxymethyl 1 aza 3,7 dioxabicyclo( 3.3.0) octane ( 16.0%), ( component B) and 5 hydroxypoly( methyleneoxy)* methyl 1 aza 3,7 dioxabicyclo( 3.3.0) octane ( 6.2%), ( component C) where the polychain is extended as: 74% C2, 21% C3, AND 4% C4, AND 1% C5 ( meaning from 1 C to C5 chain lengths of CH2O groups are added). EPI Suite lacks estimation of the third of the three isomers ( CAS# 56709 13 8).

Under abiotic conditions, the mixture of these acetals is hydrolytically unstable with half life of 0.347 days at pH 5, 1.74 days at pH 7 and approximately 15 days at pH 9. It is, therefore, not likely to be persistent in water.

Components A and B of the mixture are likely to volatilize into the atmosphere as their vapor pressures vary between 0.0004 to 0.003 mm Hg. Component C is likely to have less volatility as the side chain of CH2O groups are added into the structure. Estimated half lives in the atmosphere for components A and B are 1.2 and 1.4 hours. Hence these two chemicals are not likely to persist in the atmosphere. Estimated log Kow s of components A and B are respectively are  2.23 and  1.55 ( very highly miscible in water and show no tendency for dissolving organic solvents), the mixture is not likely to bioaccumulate in aquatic organisms.

MITI linear biodegradability ( modified linear biodegradation method) for components A and B indicates a fast biodegradation is highly probable in soils and water. Most likely these pesticides do not pose a concern for surface and ground water contamination APPENDIX FOR ENVIRONMENTAL FATE CHAPTER Methodology and Results:

Buffered aqueous solutions of Neusept 95 samples were analyzed for two durations: first 24 hours and second set for the intervals up to 33 days. Possible degradation of Neuspet 95 was followed by the GC peak changes of Oxazolidine T, which was added into the samples as a reference material. The initial concentrations of the solutions were kept at 250 µ g/ ml. All test solutions, for the duration of study were kept in dark, and temperature was maintained between 24.9 to 25.1 o C For the 33 day study, samples were chromatographically analyzed at the intervals of 1,3, 7, 14, 21, and 33 days. For the short duration study of 24 hours, the samples were analyzed at the end of 24 hours. For the 24 hour short term study, the percent recovery of Oxazolidine T was: 0.65% at pH 5, 19.2% at pH 7, and 28.4% for pH 9. This indicates that at least 70% of the samples degraded at pH 9 almost 80% at pH 7 and almost 95% at pH 5. For the 33 day study, at the end of 33 day duration, the percent recoveries of Oxazoldine T were: 2% at pH 5, 20.2% at pH 7, and 27.6% at pH 9., which are almost the same, within the margin of errors, as for the 24 hour study recoveries. It is clear that the degradation is more rapid under acidic conditions ( pH 5) and less so at neutral ( pH 7) or basic conditions ( pH 9). To ascertain where the degradation takes place in any of the three isomers, degradation study was conducted in: a) unbuffered solution of Oxazolidine T and b) unbuffered solution of oxazolidine in the presence of 0.1% formalin. The solution ( b) remained unchanged after twenty four hours; however, the unbuffered solution ( a) without formalin degraded gradually and percent recoveries of oxazolidine were low. This possibly indicate that with the addition of formalin, the ring hydrolysis of oxazolidine was prevented, while the side chain with CH2O ( formaldehyde group) depolymerized. The kinetic rate constants for the forward reactions ( kf) and the reverse reaction ( kr) were calculated as follows:

pH kf kr pH kf kr 5 1.95 0.047 7 0.41 0.109 9 0.436 0.198 The calculated half life values from these rate constants ( assuming first order kinetics are: 0.347 days,, 1.74 days and 15 days taking into account the forward reactions ( degradations) only. BIBLIOGRAPHY MRID# CITATIONS 430607 01 John Cross, Aqueous Hydrolysis of Neusept 95, EPL Bio Analytical Services, Harrison IL, 1993  EPI Suite


[Federal Register Volume 79, Number 226 (Monday, November 24, 2014)]
[Notices]
[Pages 69860-69863]
[FR Doc No: 2014-27713]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2011-D-0360 and FDA-2011-D-0357]

Framework for Regulatory Oversight of Laboratory Developed Tests;
Public Workshop; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

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

    The Food and Drug Administration (FDA) is announcing the following
public workshop entitled ``Framework for Regulatory Oversight of
Laboratory Developed Tests (LDTs).'' The purpose of this workshop is to
discuss FDA's proposal for a risk-based framework for addressing the
regulatory oversight of a subset of in vitro diagnostic devices (IVDs)
referred to as laboratory developed tests (LDTs), which are intended
for clinical use and designed, manufactured and used within a single
laboratory, and provide an additional opportunity for public comment
    Dates and Times: The 2-day public workshop will be held on January
8, 2015, from 8:30 a.m. to 5:30 p.m. and on January 9, 2015 from 8:30
a.m. to 5:30 p.m.
    Location: The public workshop will be held at the Natcher Center at
the National Institutes of Health Campus, 9000 Rockville Pike, Bldg.
45, Auditorium, Bethesda, MD 20814. For parking and security
information, please refer to http://www.nih.gov/about/visitor/.
    Contact Person: Allen Webb, Center for Devices and Radiological
Health, Food and Drug Administration, Bldg. 66, Rm 5675, 10903 New
Hampshire Ave., Silver Spring, MD 20993,<PHONE_NUMBER>,
<EMAIL_ADDRESS>    Registration: Registration is free and available on a first-come,
first-served basis. Persons interested in attending this public
workshop must register online by December 12, 2014, at 4 p.m. Early
registration is recommended because facilities are limited and,
therefore, FDA may limit the number of participants from each
organization. If time and space permits, onsite registration on the day
of the public workshop will be provided beginning at 8 a.m.
    If you need special accommodations due to a disability, please
contact Susan Monahan, (email<EMAIL_ADDRESS>or phone: 301-
796-5661) no later than December 19, 2014.
    To register for the public workshop, please visit FDA's Medical
Devices News & Events--Workshops & Conferences calendar at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm.
(Select this meeting/public workshop from the posted events list.)
Please provide complete contact information for each attendee,
including name, title, affiliation, email, and telephone number. If you
are unable to register online, please contact Susan Monahan (see
Registration.) Registrants will receive confirmation after they have
been accepted and will be notified if they are on a waiting list.

    Streaming Webcast of the Public Workshop: This public workshop will
also be Webcast. Persons interested in viewing the Webcast must
register online. Early registration is recommended because Webcast
connections are limited. Organizations are requested to register all
participants, but to view using one connection per location. Webcast
participants will be sent technical system requirements and connection
access information after registration and prior to the meeting. If you
have never attended a Connect Pro event before, test your connection at
https://collaboration.fda.gov/common/help/en/support/meeting_test.htm.
To get a quick overview of the Connect Pro program, visit http://www.adobe.com/go/connectpro_overview. (FDA has verified the Web site
addresses in this document, but FDA is not responsible for any
subsequent changes to the Web sites after this document publishes in
the Federal Register.) The Webcast will be recorded and posted on FDA's
Web site after the meeting.
    Requests for Oral Presentations: This public workshop includes
topic-focused public comment sessions. During online registration you
may indicate if you wish to present during a public comment session,
and which topics you wish to address. FDA has included general topics
in this document. FDA will do its best to accommodate requests to make
public comment. Individuals and organizations with common interests are
urged to consolidate or coordinate their presentations, and request
time for a joint presentation, or submit requests for designated
representatives to participate in the focused sessions. Following the
close of registration, FDA will determine the amount of time allotted
to each presenter and the approximate time each oral presentation is to
begin, and will select and notify participants by December 17, 2014.
All requests to make oral presentations must be received by the close
of registration on December 12, 2014. If selected for presentation, any
presentation materials must be emailed to Allen Webb (see Contact
Person) no later than January 6, 2015. No commercial or promotional
material will be permitted to be presented or distributed at the public
workshop.
    Comments: In order to permit the widest possible opportunity to
obtain public comment, FDA is soliciting either electronic or written
comments on all aspects of the public workshop topics. The deadline for
submitting comments related to this public workshop is February 2,
2015.
    Regardless of attendance at the public workshop, interested persons
may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852. It is only necessary to send one set of
comments. Identify comments with the docket number found in brackets in
the heading of this document. In addition, when responding to specific
questions as outlined in section II of this document, please identify
the question you are addressing. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday, and will be posted to the docket at http://www.regulations.gov.
    Transcripts: Please be advised that as soon as a transcript is
available, it will be accessible at http://www.regulations.gov. It may
be viewed at the Division of Dockets Management (see Comments). A
transcript will also be available in either hardcopy or on CD-ROM,
after submission of a Freedom of Information request. Written requests
are to be sent to the Division of Freedom of Information (ELEM-1029),
Food and Drug Administration, 12420 Parklawn Dr., Element Bldg.,
Rockville, MD 20857. A link to the transcripts will also be available
approximately 45 days after the public workshop on the Internet at
http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public workshop from the posted events list).

SUPPLEMENTARY INFORMATION:

I. Background

    In 1976, Congress enacted the Medical Device Amendments (MDA),
which amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act)
to create a comprehensive system for the regulation of medical devices
intended for use in humans. At that time, the definition of a device
was amended to make explicit that it encompassed in vitro diagnostic
devices (IVDs): ``The term `device'. . .means an instrument, apparatus,
implement, machine, contrivance, implant, in vitro reagent, or other
similar or related article. . . .'' (section 201(h) of the FD&C Act (21
U.S.C. 321(h)). The definition of device applies equally to IVDs
manufactured by conventional device manufacturers and those
manufactured by laboratories. An IVD, therefore, meets the device
definition irrespective of where and by whom it is manufactured.
    Since the implementation of the MDA of 1976, FDA has exercised
enforcement discretion so that the Agency has generally not enforced
applicable provisions under the FD&C Act and FDA regulations with
respect to LDTs, a subset of IVDs that are intended for clinical use
and designed, manufactured, and used within a single laboratory.
    In 1976, LDTs were mostly manufactured in small volumes by local
laboratories. Many laboratories manufactured LDTs that were similar to
well-characterized, standard diagnostic devices, as well as other LDTs
that were intended for use in diagnosing rare diseases or for other
uses to meet the needs of a local patient population. LDTs at the time
tended to rely on the manual techniques used by laboratory personnel.
LDTs were typically used and interpreted directly by physicians and
pathologists working within a single institution that was responsible
for the patient. In addition, historically, LDTs were manufactured
using components that were legally marketed for clinical use (i.e.,
general purpose reagents, immunohistochemical stains, and other
components marketed in compliance with FDA regulatory requirements).
    Although some laboratories today still manufacture LDTs in this
``traditional'' manner, the landscape for laboratory testing in
general, and LDTs along with it, has changed dramatically since 1976.
Today, LDTs are often used in laboratories that are independent of the
healthcare delivery entity. Additionally, LDTs are frequently
manufactured with components and instruments that are not legally
marketed for clinical use and also rely more heavily on complex, high-
tech instrumentation and software to generate results and clinical
interpretations. Moreover, technological advances have increased the
use of diagnostic devices in guiding critical clinical management
decisions for high-risk diseases and conditions, particularly in the
context of personalized medicine.
    Business models for laboratories have also changed since 1976. With
the advent of overnight shipping and electronic delivery of information
(e.g., device results), a single laboratory can now easily provide
device results nationally and internationally. Today, many new LDT
manufacturers are large corporations that nationally market a limited
number of complex, high-risk devices, in contrast to 1976 when hospital
or public health laboratories used a wide range of devices that were
generally either well characterized and similar to standard devices;
used to diagnose rare diseases; or designed specifically to meet the
needs of their local patients. Together, these changes

have resulted in a significant shift in the types of LDTs developed,
the business model for developing them, and the potential risks they
pose to patients.
    Because of changes in the complexity and use of LDTs and the
associated increased risks, as described earlier, FDA believes the
policy of general enforcement discretion towards LDTs is no longer
appropriate. To initiate this step toward greater oversight, FDA held a
2-day public meeting on July 19 and 20, 2010, to provide a forum for
stakeholders to discuss issues and concerns surrounding greater
oversight of LDTs. Comments submitted to the public docket for the July
19 and 20, 2010, public meeting were reviewed and, as appropriate,
incorporated into FDA's current proposed framework for regulatory
oversight of LDTs. FDA's July 31, 2014, Notification to Congress
concerning the Agency's intent to issue the draft guidance, ``Framework
for Regulatory Oversight of Laboratory Developed Tests (LDTs)''
(Framework draft guidance document), and the accompanying draft
guidance, ``FDA Notification and Medical Device Reporting for
Laboratory Developed Tests (LDTs),'' was made publicly available, and
these draft guidance documents were subsequently issued on October 3,
2014. See 79 FR 59776 and 79 FR 59779 (October 3, 2014). These
documents describe a risk-based framework for addressing the regulatory
oversight of LDTs, including FDA's priorities for enforcing premarket
and postmarket requirements for LDTs as well as the process by which
FDA intends to phase in enforcement of FDA regulatory requirements for
LDTs over time. As outlined in the Framework draft guidance document,
FDA proposes to continue to exercise enforcement discretion for all
applicable regulatory requirements for LDTs used solely for forensic
(law enforcement) purposes as well as certain LDTs for transplantation
when used in certified, high-complexity histocompatibility
laboratories. Additionally, FDA proposes to exercise enforcement
discretion for applicable premarket review requirements and quality
systems (QS) requirements, but enforce other applicable regulatory
requirements, including registration and listing (with the option to
provide notification instead) and adverse event reporting, for low-risk
LDTs (class I devices), LDTs for rare diseases, Traditional LDTs and
LDTs for Unmet Needs, as described in the Framework draft guidance
document. For other high- and moderate-risk LDTs, FDA proposes to
enforce applicable regulatory requirements, including registration and
listing (with the option to provide notification instead) and adverse
event reporting, and phase in enforcement of premarket and QS
requirements in a risk-based manner.
    With the publication of the draft guidances, FDA announced a public
comment period soliciting feedback on all aspects of the guidance
documents as well as on the following specific issues: (1) Factors for
``Traditional LDT'' and appropriate level of enforcement discretion for
such tests; (2) factors for considering LDTs for rare diseases; (3)
manufacture and use of LDTs solely within a healthcare system as a risk
mitigation supporting some continued enforcement discretion; (4)
timeframe for phase-in enforcement of QS regulation requirements for
those LDTs called in for enforcement of premarket review requirements
early in the implementation period; and (5) the appropriateness of a
single notification for the same LDT manufactured by multiple labs
owned by a single entity.
    FDA intends to use this public workshop as a forum for open
discussion with all stakeholders regarding these specific issues as
well as other considerations for how to best balance patient safety and
patient access in developing the finalized framework in a manner that
best serves public health.

II. Topics for Discussion at the Public Workshop

    Issues to be considered during the sessions include:

Session 1: Components of a Test and LDT Labeling Considerations
     What components do FDA cleared/approved tests and LDTs
typically include?
     What labeling considerations should be taken into account
for LDTs?
     How does LDT labeling affect and not affect physician
consultation with the laboratory?
Session 2: Clinical Validity/Intended Use
     What is clinical validity and how is it demonstrated for
IVDs, including LDTs?
     How are clinical claims or intended use related to
clinical validity?
     What types of modifications may affect the intended use or
significantly affect the performance of a test?
Session 3: Categories for Continued Enforcement Discretion
     As a factor for consideration of continued enforcement
discretion for premarket review and QS regulation requirements for LDTs
for rare diseases, the proposed framework for LDTs relies on the
definition of a humanitarian use device (HUD) in 21 CFR 814.102(a)(5).
Under this definition, an IVD may qualify for HUD designation when the
number of persons in the United States who may be tested with the
device is fewer than 4,000 per year. Is this an appropriate factor for
LDTs for rare diseases? If not, what factor should FDA consider for
LDTs for rare diseases?
     Should enforcement discretion be limited to tests for rare
diseases that meet the definition of an LDT (a test designed,
manufactured and used within a single laboratory)?
     Are the following three factors the appropriate controls
to mitigate risks due to Traditional LDTs so that continued enforcement
discretion is appropriate with respect to premarket review and quality
system requirements whether the test is: (1) An LDT (designed,
manufactured and used within a single laboratory); (2) comprised of
only components and instruments that are legally marketed for clinical
use, which have a number of regulatory controls in place, including
reporting of adverse events; and (3) interpreted by laboratory
professionals who are appropriately qualified and trained as required
by the CLIA (Clinical Laboratory Improvement Amendments) regulations
(see, e.g., 42 CFR 493.1449), without the use of automated
instrumentation or software for interpretation? Are these three factors
also sufficient to support continued enforcement discretion in full
(i.e., for all regulatory requirements rather than just for premarket
review and quality system requirements) for this category of LDTs?
Should FDA instead consider different factors?
     FDA has proposed the following three factors for
consideration of continued enforcement discretion for premarket review
and QS requirements for LDTs for Unmet Needs whether: (1) The device
meets the definition of an LDT (a test designed, manufactured and used
by a single laboratory); (2) there is no FDA cleared or approved IVD
available for that specific intended use; and (3) the LDT is both
manufactured and used by a healthcare facility laboratory (such as one
located in a hospital or clinic) for a patient that is being diagnosed
and/or treated at that same healthcare facility or within

that facility's healthcare system. Are these factors appropriate and/or
sufficient to both mitigate risks and to provide patient access if
warranted? Should FDA use different factors to best balance patient
safety and patient access?
     For the categories of Traditional LDTs and LDTs for Unmet
Needs, one of the factors for enforcement discretion is whether the LDT
is both manufactured and used by a healthcare facility laboratory (such
as one located in a hospital or clinic) for a patient that is being
diagnosed and/or treated at that same healthcare facility, or within
the facility's healthcare system. To further clarify this factor, the
Framework draft guidance document explains that ``healthcare system''
refers to a collection of hospitals that are owned and operated by the
same entity and that share access to patient care information for their
patients, such as, but not limited to, drug order information,
treatment and diagnosis information, and patient outcomes. If this is
an appropriate factor to use, are the considerations about which types
of facilities would or would not be included within a healthcare system
as defined by the draft guidance appropriate? Is there an alternative
definition of healthcare system that would be more appropriate?
     Do the FDA-proposed categories for continued enforcement
discretion appropriately encompass the LDTs that should remain under
enforcement discretion? Should the scope of proposed categories be
broadened or narrowed? If so, how? Should additional categories for
continued enforcement discretion be added or proposed categories
removed? If so, which categories? For any new proposed categories, what
are the appropriate factors in considering enforcement discretion?
     Is the information provided detailed enough for
laboratories to make a determination that their LDT falls within one of
these categories of continued enforcement discretion?
Session 4: Notification and Adverse Event Reporting (MDRs)
     Will notification be adequate to provide FDA,
laboratories, providers, patients, and other members of the public a
comprehensive list of what tests are currently available for a specific
intended use?
     Would it be sufficient to allow laboratory networks (i.e.,
more than one laboratory under the control of the same parent entity)
that offer the same test in multiple laboratories throughout their
network to submit a single notification for that test?
     Are there certain types of LDTs for which the Agency
should neither enforce requirements for registration and listing nor
request notification in lieu of registration and listing?
     How can FDA leverage other information in the community to
reduce the information collection associated with notification for
laboratories while still obtaining sufficient information to inform the
LDT classification and prioritization process?
Session 5: Public Process for Classification and Prioritization
     How should FDA structure the advisory panels that will be
convened to provide input to help FDA classify LDTs and prioritize them
for enforcement of FDA premarket review requirements?
     Which stakeholders should be able to present relevant
information or views at the panel meetings to discuss the
classification and prioritization of LDTs?
     What factors should be considered in determining LDT
classification and risk?
     How should the advisory panel process weigh these factors
when providing input for classifying LDTs and prioritizing LDTs for
enforcement of FDA premarket review requirements?
Session 6: Quality System Regulation
     How can laboratories best leverage their current processes
and procedures, implemented to meet CLIA accreditation requirements, to
meet the FDA QS regulation requirements in the least burdensome manner?
     Are there FDA QS requirements that differ from CLIA
requirements that FDA should continue not to enforce for laboratories
that make LDTs?
     What additional resources will laboratories need in order
to assist them with implementation of the QS regulation?
     What is the appropriate timeframe for phase-in enforcement
of QS regulation requirements in general and for design controls
specifically?

    Dated: November 17, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-27713 Filed 11-21-14; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 84, Number 79 (Wednesday, April 24, 2019)]
[Notices]
[Page 17152]
[FR Doc No: 2019-08218]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. EL19-64-000, QF19-907-002, QF19-908-002]

Rockville Solar I LLC, Rockville Solar II LLC, Rockville Solar I
LLC, Rockville Solar II LLC; Notice of Petition for Declaratory Order

    Take notice that on April 15, 2019, pursuant to Rule 207(a)(2) of
the Commission's (Commission) Rules of Practice and Procedure,\1\
Rockville Solar I LLC and Rockville Solar II LLC (collectively, the
Applicants or Petitioners) filed a joint petition for declaratory order
(petition) requesting that the Commission grant partial waivers of the
filing requirement in section 292.203(a)(3) of the Commission's
regulations (QF Filing Requirement) \2\ for the time-period beginning
April 9, 2014 for the Rockville Solar I solar project and beginning on
August 19, 2014 for the Rockville Solar II solar project and ending on
March 6, 2019, when each of the Applicants filed the required Form 556
self-certifications for each of the Projects to become a qualifying
facility (the requested waiver period),\3\ all as more fully explained
in the petition.
---------------------------------------------------------------------------

    \1\ 18 CFR 385.207 (2018).
    \2\ 18 CFR 292.203(a)(3) (2018).
    \3\ See Rockville Solar I, Docket No. QF19-907-000 and Rockville
Solar II, Docket No. QF19-908-000.
---------------------------------------------------------------------------

    Any person desiring to intervene or to protest in this proceeding
must file in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214) on or
before 5:00 p.m. Eastern time on the specified comment date. Protests
will be considered by the Commission in determining the appropriate
action to be taken, but will not serve to make protestants parties to
the proceeding. Any person wishing to become a party must file a notice
of intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date.
Anyone filing a motion to intervene or protest must serve a copy of
that document on the Petitioners.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
5 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE, Washington, DC 20426.
    The filings in the above proceeding are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the website that enables subscribers to receive email notification
when a document is added to a subscribed docket(s). For assistance with
any FERC Online service, please email [email protected] or
call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern time on May 15, 2019.

    Dated: April 17, 2019.
Kimberly D. Bose,
Secretary.
[FR Doc. 2019-08218 Filed 4-23-19; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 236 (Monday, December 10, 2018)]
[Notices]
[Pages 63493-63494]
[FR Doc No: 2018-26639]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following electric
rate filings:
    Docket Numbers: ER10-3307-004.
    Applicants: NRG Energy Center Dover LLC.
    Description: Compliance filing: Compliance Filing of Reactive Power
Rate Schedule to be effective 5/9/2018.
    Filed Date: 11/30/18.
    Accession Number: 20181130-5147.
    Comments Due: 5 p.m. ET 12/21/18.

    Docket Numbers: ER12-1933-009; ER12-1934-008.
    Applicants: Interstate Power and Light Company, Wisconsin Power and
Light Company.
    Description: Second Supplement to June 29, 2018 Updated Triennial
Market Power analysis for the Central region of Interstate Power and
Light Company, et. al.
    Filed Date: 11/30/18.
    Accession Number: 20181130-5210.
    Comments Due: 5 p.m. ET 12/21/18.

    Docket Numbers: ER17-135-007.
    Applicants: DesertLink, LLC.
    Description: Compliance filing: Compliance Filing--Desert Link to
be effective 11/30/2018.
    Filed Date: 11/30/18.
    Accession Number: 20181130-5238.
    Comments Due: 5 p.m. ET 12/21/18.

    Docket Numbers: ER18-169-000.
    Applicants: Southern California Edison Company.
    Description: Informational Filing of Notice of Revision to Formula
Transmission Rate Annual Update of Southern California Edison Company.
    Filed Date: 11/29/18.
    Accession Number: 20181129-5272.
    Comments Due: 5 p.m. ET 12/20/18.

    Docket Numbers: ER18-459-004.
    Applicants: Ohio Valley Electric Corporation, PJM Interconnection,
L.L.C.
    Description: Compliance filing: PJM and OVEC submit revisions to
the OATT re: OVEC Zones Trans. Rate Update to be effective 12/1/2018.
    Filed Date: 11/30/18.
    Accession Number: 20181130-5032.
    Comments Due: 5 p.m. ET 12/21/18.

    Docket Numbers: ER18-2208-001.
    Applicants: New England Power Pool Participants Committee.
    Description: Tariff Amendment: 132nd Agreement Deficiency Letter
Response to be effective 11/1/2018.
    Filed Date: 11/30/18.
    Accession Number: 20181130-5282.
    Comments Due: 5 p.m. ET 12/21/18.

    Docket Numbers: ER19-151-000.
    Applicants: MATL LLP.
    Description: Report Filing: Supplement to Open Solicitation Filing
to be effective N/A.
    Filed Date: 11/29/18.
    Accession Number: 20181129-5196.
    Comments Due: 5 p.m. ET 12/20/18.

    Docket Numbers: ER19-158-001.
    Applicants: Ambit Northeast, LLC.
    Description: Tariff Amendment: Ambit Northeast LLC Amended MBR
Application to be effective 10/22/2018.
    Filed Date: 11/30/18.
    Accession Number: 20181130-5272.
    Comments Due: 5 p.m. ET 12/21/18.

    Docket Numbers: ER19-429-000.
    Applicants: Mid-Atlantic Interstate Transmission, LLC, PJM
Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: MAIT submits OIA SA No. 4577
to be effective 1/29/2019.
    Filed Date: 11/29/18.
    Accession Number: 20181129-5197.
    Comments Due: 5 p.m. ET 12/20/18.

    Docket Numbers: ER19-430-000.
    Applicants: Enel Green Power Hilltopper Wind, LLC.
    Description: Compliance filing: Notice of Non-Material Change in
Status to be effective 11/30/2018.
    Filed Date: 11/29/18.
    Accession Number: 20181129-5198.
    Comments Due: 5 p.m. ET 12/20/18.

    Docket Numbers: ER19-431-000.
    Applicants: NSTAR Electric Company.
    Description: Sec.  205(d) Rate Filing: Distribution Service
Agreement between NSTAR Electric Co. and MATEP LLC to be effective 1/
30/2019.
    Filed Date: 11/29/18.
    Accession Number: 20181129-5219.
    Comments Due: 5 p.m. ET 12/20/18.

    Docket Numbers: ER19-432-000.
    Applicants: Pacific Gas and Electric Company.
    Description: Sec.  205(d) Rate Filing: PG&E Coyote Valley Energy
Storage SGIA (SA 407) to be effective 1/30/2019.
    Filed Date: 11/30/18.
    Accession Number: 20181130-5000.
    Comments Due: 5 p.m. ET 12/21/18.

    Docket Numbers: ER19-433-000.
    Applicants: Union Electric Company.
    Description: Sec.  205(d) Rate Filing: Revised Reactive Rate
Schedule 22 to be effective 12/1/2018.
    Filed Date: 11/30/18.
    Accession Number: 20181130-5001.
    Comments Due: 5 p.m. ET 12/21/18.

    Docket Numbers: ER19-433-001.
    Applicants: Union Electric Company.
    Description: Tariff Amendment: Amended Reactive Rate Schedule 22 to
be effective 12/1/2018.
    Filed Date: 11/30/18.
    Accession Number: 20181130-5173.
    Comments Due: 5 p.m. ET 12/21/18.

    Docket Numbers: ER19-434-000.
    Applicants: Steamboat Hills LLC.
    Description: Sec.  205(d) Rate Filing: Revisions to Market-Based
Rate Tariff (Steamboat Hills LLC) to be effective 1/30/2019.
    Filed Date: 11/30/18.
    Accession Number: 20181130-5054.
    Comments Due: 5 p.m. ET 12/21/18.

    Docket Numbers: ER19-435-000.
    Applicants: ORNI 47 LLC.
    Description: Sec.  205(d) Rate Filing: Revisions to Market-Based
Rate Tariff (ORNI 47 LLC) to be effective 1/30/2019.
    Filed Date: 11/30/18.
    Accession Number: 20181130-5057.
    Comments Due: 5 p.m. ET 12/21/18.

    Docket Numbers: ER19-436-000.
    Applicants: ORNI 43 LLC.
    Description: Sec.  205(d) Rate Filing: Revisions to Market-Based
Rate Tariff (ORNI 43 LLC) to be effective 1/30/2019.
    Filed Date: 11/30/18.
    Accession Number: 20181130-5063.
    Comments Due: 5 p.m. ET 12/21/18.

    Docket Numbers: ER19-437-000.
    Applicants: ORNI 39 LLC.
    Description: Sec.  205(d) Rate Filing: Revisions to Market-Based
Rate Tariff (ORNI 39 LLC) to be effective 1/30/2019.

    Filed Date: 11/30/18.
    Accession Number: 20181130-5064.
    Comments Due: 5 p.m. ET 12/21/18.

    Docket Numbers: ER19-438-000.
    Applicants: ORNI 37 LLC.
    Description: Sec.  205(d) Rate Filing: Revisions to Market-Based
Rate Tariff (ORNI 37 LLC) to be effective 1/30/2019.
    Filed Date: 11/30/18.
    Accession Number: 20181130-5066.
    Comments Due: 5 p.m. ET 12/21/18.

    Docket Numbers: ER19-439-000.
    Applicants: ORNI 14 LLC.
    Description: Sec.  205(d) Rate Filing: Revisions to Market-Based
Rate Tariff (ORNI 14 LLC) to be effective 1/30/2019.
    Filed Date: 11/30/18.
    Accession Number: 20181130-5071.
    Comments Due: 5 p.m. ET 12/21/18.

    Docket Numbers: ER19-440-000.
    Applicants: Ormesa LLC.
    Description: Sec.  205(d) Rate Filing: Revisions to Market-Based
Rate Tariff (Ormesa LLC) to be effective 1/30/2019.
    Filed Date: 11/30/18.
    Accession Number: 20181130-5072.
    Comments Due: 5 p.m. ET 12/21/18.

    Docket Numbers: ER19-441-000.
    Applicants: ONGP LLC.
    Description: Sec.  205(d) Rate Filing: Revisions to Market-Based
Rate Tariff (ONGP LLC) to be effective 1/30/2019.
    Filed Date: 11/30/18.
    Accession Number: 20181130-5073.
    Comments Due: 5 p.m. ET 12/21/18.

    Docket Numbers: ER19-442-000.
    Applicants: Mammoth Three LLC.
    Description: Sec.  205(d) Rate Filing: Revisions to Market-Based
Rate Tariff (Mammoth Three LLC) to be effective 1/30/2019.
    Filed Date: 11/30/18.
    Accession Number: 20181130-5075.
    Comments Due: 5 p.m. ET 12/21/18.

    Docket Numbers: ER19-443-000.
    Applicants: Heber Geothermal Company LLC.
    Description: Sec.  205(d) Rate Filing: Revisions to Market-Based
Rate Tariff (Heber Geothermal Company LLC) to be effective 1/30/2019.
    Filed Date: 11/30/18.
    Accession Number: 20181130-5077.
    Comments Due: 5 p.m. ET 12/21/18.

    Docket Numbers: ER19-444-000.
    Applicants: ISO New England Inc., New England Power Pool
Participants Committee.
    Description: Sec.  205(d) Rate Filing: ISO-NE and NEPOOL;
Conforming Changes to ISO Tariff for CASPR to be effective 1/29/2019.
    Filed Date: 11/30/18.
    Accession Number: 20181130-5103.
    Comments Due: 5 p.m. ET 12/21/18.

    Docket Numbers: ER19-445-000.
    Applicants: Ohio Valley Electric Corporation.
    Description: Tariff Cancellation: Notice of Cancellation to be
effective 12/1/2018.
    Filed Date: 11/30/18.
    Accession Number: 20181130-5164.
    Comments Due: 5 p.m. ET 12/21/18.

    Docket Numbers: ER19-446-000.
    Applicants: New England Power Pool Participants Committee.
    Description: Sec.  205(d) Rate Filing: December 2018 Membership
Filing to be effective 11/1/2018.
    Filed Date: 11/30/18.
    Accession Number: 20181130-5166.
    Comments Due: 5 p.m. ET 12/21/18.

    Docket Numbers: ER19-447-000.
    Applicants: ISO New England Inc., New England Power Pool
Participants Committee.
    Description: ISO New England Inc., et al. submits Installed
Capacity Requirement, Hydro Quebec Interconnection Capability Credits
and Related Values for the 2019/2020, et al. Annual Reconfiguration
Auction.
    Filed Date: 11/30/18.
    Accession Number: 20181130-5169.
    Comments Due: 5 p.m. ET 12/21/18.

    Docket Numbers: ER19-448-000.
    Applicants: Appalachian Power Company.
    Description: Sec.  205(d) Rate Filing: OATT-Revise Attachment K,
AEP Texas Inc. Rate Update to be effective 12/31/9998.
    Filed Date: 11/30/18.
    Accession Number: 20181130-5237.
    Comments Due: 5 p.m. ET 12/21/18.

    Docket Numbers: ER19-449-000.
    Applicants: ISO New England Inc., New England Power Pool
Participants Committee.
    Description: Sec.  205(d) Rate Filing: ISO-NE and NEPOOL; Revisions
to Clarify Treatment of Retiring Resources to be effective 1/29/2019.
    Filed Date: 11/30/18.
    Accession Number: 20181130-5247.
    Comments Due: 5 p.m. ET 12/21/18.

    Docket Numbers: ER19-450-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Sec.  205(d) Rate Filing: 3396R1 Otter Tail Power
Company NITSA and NOA to be effective 2/1/2019.
    Filed Date: 11/30/18.
    Accession Number: 20181130-5253.
    Comments Due: 5 p.m. ET 12/21/18.

    Docket Numbers: ER19-451-000.
    Applicants: Pacific Gas and Electric Company.
    Description: Sec.  205(d) Rate Filing: November 2018 Western
Interconnection Agreement Biannual Filing to be effective 2/1/2019.
    Filed Date: 11/30/18.
    Accession Number: 20181130-5257.
    Comments Due: 5 p.m. ET 12/21/18.

    Docket Numbers: ER19-452-000.
    Applicants: Pacific Gas and Electric Company.
    Description: Sec.  205(d) Rate Filing: November 2018 Western WDT
Service Agreement Biannual Filing to be effective 2/1/2019.
    Filed Date: 11/30/18.
    Accession Number: 20181130-5264.
    Comments Due: 5 p.m. ET 12/21/18.

    Docket Numbers: ER19-453-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Sec.  205(d) Rate Filing: MA Amendments for Mor-Gran-
Sou Electric Cooperative, Inc. to be effective 11/19/2018.
    Filed Date: 11/30/18.
    Accession Number: 20181130-5279.
    Comments Due: 5 p.m. ET 12/21/18.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: November 30, 2018.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2018-26639 Filed 12-7-18; 8:45 am]
 BILLING CODE P


			  UNITED STATES OF AMERICA

		        DEPARTMENT OF TRANSPORTATION

			  OFFICE OF THE SECRETARY

			          WASHINGTON, D.C.

Issued by the Department of Transportation on November 12, 2003

NOTICE OF ACTION TAKEN -- DOCKET OST 2003-16361

________________________________________________________________________
________________________________________

This serves as notice to the public of the action described below, taken
by the Department official indicated (no additional confirming order
will be issued in this matter).

Application of    Hawaiian Airlines, Inc. (Hawaiian),   filed  10/21/03
for:

XX  Exemption for two years under 49 U.S.C. §40109 to provide the
following service:

Scheduled foreign air transportation of persons, property, and mail
between the terminal point Phoenix, Arizona, on the one hand, and the
coterminal points Acapulco, Cancun, Guadalajara, Hermosillo, Mexico
City, Monterrey, San Jose del Cabo, and Zihuatanejo/Ixtapa, Mexico, on
the other hand.  Hawaiian states that it will serve the markets be
placing its two letter “HA” designator code on flights operated by
America West and the America West Express carriers Mesa Airlines (to
Hermosillo and Monterrey), and Freedom Airlines (to Guadalajara).

Applicant rep:   Jonathan B. Hill<PHONE_NUMBER>    DOT Analyst:  Linda
L. Lundell<PHONE_NUMBER>

D I S P O S I T I O N

XX  Granted, subject to conditions (see below).

The action above was effective when taken:  November 12, 2003,  through
November 12, 2005.

Action taken by:     Paul L. Gretch, Director

  		        Office of International Aviation

XX  Authority granted is consistent with the aviation agreement between
the United States and Mexico.

Except to the extent exempted or waived, this authority is subject to
the terms, conditions, and limitations indicated:

XX  Holder’s certificates of public convenience and necessity

XX  Standard Exemption Conditions (attached)

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

Special Conditions/Remarks:  The U.S.-Mexico exemption authority granted
is subject to the dormancy notice requirements set forth in condition 7
of Appendix A of Order 88-10-2.  The exemption authority granted is
limited to services provided on a code-share basis only.

The code-share operations conducted under this authorization are subject
to the following conditions:  (a) The code-sharing operations conducted
under this authority must comply with 14 CFR 257 and with any amendment
to the Department’s regulations concerning code-share arrangements
that may be adopted.  Notwithstanding any provisions in the contract
between the carriers, our approval here is expressly conditioned upon
the requirements that the subject foreign air transportation be sold in
the name of the carrier holding out such service in computer reservation
systems and elsewhere; that the carrier selling such transportation
(i.e., the carrier shown on the ticket) accept responsibility for the
entirety of the code-share journey for all obligations established in
its contract of carriage with the passenger; and that the passenger
liability of the operating carrier be unaffected; and (b) the authority
granted here is specifically conditioned so that neither Hawaiian nor
America West/America West Express carriers (Mesa Airlines and Freedom
Airlines) shall give any force or effect to any contractual provisions
between themselves that are contrary to these conditions.

- see next page -

														2

________________________________________________________________________
________________________________________________________

On the basis of data officially noticeable under Rule 24(g) of the
Department’s regulations, we found the applicant qualified to provide
the services authorized.

Under authority assigned by the Department in its regulations, 14 CFR
Part 385, we found that (1) our action was consistent with Department
policy; (2) grant of the application was consistent with the public
interest; and (3) grant of the authority would not constitute a major
regulatory action under the Energy Policy and Conservation Act of 1975.
 To the extent not granted, we denied all requests in the referenced
Docket.  We may amend, modify, or revoke the authority granted in this
Notice at any time without hearing at our discretion.

Persons entitled to petition the Department for review of the action set
forth in this Notice under the Department’s regulations, 14 CFR
§385.30, may file their petitions within seven (7) days after the date
of issuance of this Notice.  This action was effective when taken, and
the filing of a petition for review will not alter such effectiveness.

An electronic version of this document is available on the World Wide
Web at:

http://dms.dot.gov/reports_aviation.asp

							APPENDIX

U.S. Carrier Standard Exemption Conditions

In the conduct of the operations authorized, the U.S. carrier
applicant(s) shall:

(1)  Hold at all times effective operating authority from the government
of each country served;

(2)  Comply with applicable requirements concerning oversales contained
in 14 CFR 250 (for scheduled operations, if authorized);

(3)  Comply with the requirements for reporting data contained in 14 CFR
241;

(4)  Comply with requirements for minimum insurance coverage, and for
certifying that coverage to the Department, contained in 14 CFR 205;

(5)  Except as specifically exempted or otherwise provided for in a
Department Order, comply with the requirements of 14 CFR 203, concerning
waiver of Warsaw Convention liability limits and defenses;

(6)  Comply with all applicable requirements of the Federal Aviation
Administration and with all applicable U.S. Government requirements
concerning security.  To assure compliance with all applicable U.S.
Government requirements concerning security, the holder shall, before
commencing any new service (including charter flights) to or from a
foreign airport, contact its Principal Security Inspector (PSI) to
advise the PSI of its plans and to find out whether the Transportation
Security Administration has determined that security is adequate to
allow such airport(s) to be served; and

(7)  Comply with such other reasonable terms, conditions, and
limitations required by the public interest as may be prescribed by the
Department of Transportation, with all applicable orders and regulations
of other U.S. agencies and courts, and with all applicable laws of the
United States.

The authority granted shall be effective only during the period when the
holder is in compliance with the conditions imposed above.

											8/2003