[Federal Register Volume 80, Number 36 (Tuesday, February 24, 2015)]
[Notices]
[Pages 9759-9763]
[FR Doc No: 2015-03653]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. IC-31457; File No. 812-14330]

Eagle Point Credit Company Inc., et al.; Notice of Application

February 18, 2015.
AGENCY: Securities and Exchange Commission (``Commission'').

ACTION: Notice of application for an order under section 17(d) of the
Investment Company Act of 1940 (the ``Act'') and rule 17d-1 under the
Act to permit certain joint transactions otherwise prohibited by
section 17(d) of the Act and rule 17d-1 under the Act.

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SUMMARY: Summary of Application: Applicants request an order to permit
Eagle Point Credit Company Inc. to co-invest in portfolio companies
with certain affiliated investment funds.
    Applicants: Eagle Point Credit Company Inc. (``EPCC''), Eagle Point
Credit Management LLC (``EPCM''), Eagle Point Credit Partners LP
(``EPCP''), Eagle Point Credit GP I LP (``General Partner''), Eagle
Point Credit Company Sub LLC (``EPCC Sub''), Eagle Point Credit
Partners Sub Ltd. (``EPCP Sub''), and Eagle Point Credit Partners Sub
III Ltd. (``EPCP Sub III'').

DATES: Filing Dates: The application was filed on July 10, 2014, and
amended on November 20, 2014 and January 30, 2015.
    Hearing or Notification of Hearing: An order granting the requested
relief will be issued unless the Commission orders a hearing.
Interested persons may request a hearing by writing to the Commission's
Secretary and serving applicants with a copy of the request, personally
or by mail. Hearing requests should be received by the Commission by
5:30 p.m. on March 16, 2015, 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
St. NE., Washington, DC 20549-1090. Applicants: 20 Horseneck Lane,
Greenwich, CT 06830.

FOR FURTHER INFORMATION CONTACT: Vanessa M. Meeks, Senior Counsel, or
Melissa R. Harke, Branch Chief, at<PHONE_NUMBER> (Chief Counsel's
Office, 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>.

Applicants' Representations

    1. EPCC (formerly Eagle Point Credit Company LLC) is a Delaware
corporation that is registered as a closed-end management investment
company under the Act. EPCC's primary investment objective is to
generate high current income, with a secondary objective to generate
capital appreciation. EPCC seeks to achieve its investment objectives
by investing primarily in equity and junior debt tranches of
collateralized loan obligations (``CLOs'') that are collateralized by a
diverse portfolio consisting primarily of below investment grade U.S.
senior secured loans. The board of directors of EPCC is currently
comprised of six directors, four of whom are not ``interested
persons,'' within the meaning of section 2(a)(19) of the Act (the
``Non-Interested Directors''), of EPCC.
    2. EPCP is a Cayman Islands exempted limited partnership that would
be an investment company under the 1940 Act but for Section 3(c)(7) of
the 1940 Act. EPCP's investment

objectives and strategies are equivalent, in all material respects, to
EPCC's Objectives and Strategies.\1\ The General Partner has ultimate
responsibility for the management of EPCP.
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    \1\ ``Objectives and Strategies'' means a Regulated Fund's (as
defined below) investment objectives and strategies, as described in
the Regulated Fund's registration statement on Form N-2, other
filings the Regulated Fund has made with the Commission under the
Securities Act of 1933 (the ``Securities Act''), or under the
Securities Exchange Act of 1934, and the Regulated Fund's reports to
shareholders.
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    3. Each of EPCP Sub and EPCP Sub III is a Cayman Islands exempted
company. EPCP Sub is a direct, wholly-owned special purpose subsidiary
of EPCP. EPCP Sub III is a direct, wholly-owned special purpose
subsidiary of EPCP Sub. EPCP Sub and EPCP Sub III are each excluded
from registration as an investment company under Section 3(c)(7) of the
1940 Act. All investment decisions relating to the assets held at EPCP
Sub and EPCP Sub III are made by EPCM as investment adviser to EPCP.
    4. EPCM is a Delaware limited liability company registered as an
investment adviser under the Investment Advisers Act of 1940 (the
``Advisers Act''). EPCM serves as the investment adviser to EPCC and
EPCP.
    5. Applicants seek an order (``Order'') to permit one or more
Regulated Funds \2\ and/or one or more Affiliated Funds \3\ to
participate in the same investment opportunities through a proposed co-
investment program (the ``Co-Investment Program'') where such
participation would otherwise be prohibited under rule 17d-1 by (a) co-
investing with each other in securities issued by issuers in private
placement transactions in which an Adviser negotiates terms in addition
to price; \4\ and (b) making additional investments in securities of
such issuers, including through the exercise of warrants, conversion
privileges, and other rights to purchase securities of the issuers
(``Follow-On Investments''). ``Co-Investment Transaction'' means any
transaction in which a Regulated Fund (or its Wholly-Owned Investment
Sub, as defined below) participates together with one or more other
Regulated Funds and/or one or more Affiliated Funds in reliance on the
requested Order. ``Potential Co-Investment Transaction'' means any
investment opportunity in which a Regulated Fund (or its Wholly-Owned
Investment Sub, as defined below) could not participate together with
one or more Affiliated Funds and/or one or more other Regulated Funds
without obtaining and relying on the Order.\5\
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    \2\ ``Regulated Fund'' means EPCC and any Future Regulated Fund.
``Future Regulated Fund'' means any closed-end management investment
company (a) that is registered under the Act, (b) whose investment
adviser is an Adviser, and (c) that intends to participate in the
Co-Investment Program. The term ``Adviser'' means (a) EPCM and (b)
any future investment adviser that controls, is controlled by or is
under common control with EPCM and is registered as an investment
adviser under the Advisers Act.
    \3\ ``Affiliated Fund'' means any of EPCP and any Future
Affiliated Fund. ``Future Affiliated Fund'' means any entity (a)
whose investment adviser is an Adviser, (b) that would be an
investment company but for section 3(c)(1) or 3(c)(7) of the Act,
and (c) that intends to participate in the Co-Investment Program.
    \4\ The term ``private placement transactions'' means
transactions in which the offer and sale of securities by the issuer
are exempt from registration under the Securities Act.
    \5\ All existing entities that currently intend to rely upon the
requested Order have been named as applicants. Any other existing or
future entity that subsequently relies on the Order will comply with
the terms and conditions of the application.
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    6. Applicants state that a Regulated Fund may, from time to time,
form one or more Wholly-Owned Investment Subs.\6\ Such a subsidiary
would be prohibited from investing in a Co-Investment Transaction with
any Affiliated Fund or Regulated Fund because it would be a company
controlled by its parent Regulated Fund for purposes of rule 17d-1.
Applicants request that each Wholly-Owned Investment Sub be permitted
to participate in Co-Investment Transactions in lieu of its parent
Regulated Fund and that the Wholly-Owned Investment Sub's participation
in any such transaction be treated, for purposes of the requested
order, as though the parent Regulated Fund were participating directly.
Applicants represent that this treatment is justified because a Wholly-
Owned Investment Sub would have no purpose other than serving as a
holding vehicle for the Regulated Fund's investments and, therefore, no
conflicts of interest could arise between the Regulated Fund and the
Wholly-Owned Investment Sub. The Regulated Fund's Board would make all
relevant determinations under the conditions with regard to a Wholly-
Owned Investment Sub's participation in a Co-Investment Transaction,
and the Regulated Fund's Board would be informed of, and take into
consideration, any proposed use of a Wholly-Owned Investment Sub in the
Regulated Fund's place. If the Regulated Fund proposes to participate
in the same Co-Investment Transaction with any of its Wholly-Owned
Investment Subs, the Board will also be informed of, and take into
consideration, the relative participation of the Regulated Fund and the
Wholly-Owned Investment Sub. EPCC Sub is a Delaware limited liability
company and is a Wholly-Owned Investment Sub of EPCC.
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    \6\ The term ``Wholly-Owned Investment Sub'' means an entity (i)
that is wholly-owned by a Regulated Fund (with the Regulated Fund at
all times holding, beneficially and of record, 100% of the voting
and economic interests); (ii) whose sole business purpose is to hold
one or more investments and issue debt on behalf of the Regulated
Fund; (iii) with respect to which the Regulated Fund's board of
directors or trustees has the sole authority to make all
determinations with respect to the entity's participation under the
conditions of the application; and (iv) that would be an investment
company but for section 3(c)(1) or 3(c)(7) of the Act.
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    7. When considering Potential Co-Investment Transactions for any
Regulated Fund, the applicable Adviser will consider only the
Objectives and Strategies, investment policies, investment positions,
capital available for investment, and other pertinent factors
applicable to that Regulated Fund. Due to the similarity in Objectives
and Strategies of certain Regulated Funds with the investment
objectives, policies and strategies of certain Affiliated Funds, the
Adviser expects that investments for a Regulated Fund should also
generally be appropriate investments for one or more other Regulated
Funds and/or one or more Affiliated Funds, with certain exceptions
based on available capital or diversification.\7\
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    \7\ The Regulated Funds, however, will not be obligated to
invest, or co-invest, when investment opportunities are referred to
them.
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    8. Other than pro rata dispositions and Follow-On Investments as
provided in conditions 7 and 8, and after making the determinations
required in conditions 1 and 2(a), the Adviser will present each
Potential Co-Investment Transaction and the proposed allocation to the
directors of the Board eligible to vote under section 57(o) of the Act
(``Eligible Directors''), and the ``required majority,'' as defined in
section 57(o) of the Act (``Required Majority'') \8\ will approve each
Co-Investment Transaction prior to any investment by the participating
Regulated Fund.
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    \8\ Although each Regulated Fund will be a registered closed-end
fund, the Board members that make up the Required Majority will be
determined as if the Regulated Fund were a BDC subject to section
57(o).
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    9. With respect to the pro rata dispositions and Follow-On
Investments provided in conditions 7 and 8, a Regulated Fund may
participate in a pro rata disposition or Follow-On Investment without
obtaining prior approval of the Required Majority if, among other
things: (i) The proposed participation of each Regulated Fund and
Affiliated Fund in such disposition is proportionate to its outstanding
investments in the issuer immediately

preceding the disposition or Follow-On Investment, as the case may be;
and (ii) the Board of the Regulated Fund has approved that Regulated
Fund's participation in pro rata dispositions and Follow-On Investments
as being in the best interests of the Regulated Fund. If the Board does
not so approve, any such disposition or Follow-On Investment will be
submitted to the Regulated Fund's Eligible Directors. The Board of any
Regulated Fund may at any time rescind, suspend or qualify its approval
of pro rata dispositions and Follow-On Investments with the result that
all dispositions and/or Follow-On Investments must be submitted to the
Eligible Directors.
    10. No Non-Interested Director of a Regulated Fund will have a
financial interest in any Co-Investment Transaction, other than through
share ownership in one of the Regulated Funds.

Applicants' Legal Analysis

    1. Section 17(d) of the Act and rule 17d-1 under the Act prohibit
affiliated persons of a registered investment company from
participating in joint transactions with the company unless the
Commission has granted an order permitting such transactions. In
passing upon applications under rule 17d-1, the Commission considers
whether the company's participation in the joint transaction is
consistent with the provisions, policies, and purposes of the Act and
the extent to which such participation is on a basis different from or
less advantageous than that of other participants.
    2. Applicants state that in the absence of the requested relief, a
Regulated Fund would be, in some circumstances, limited in its ability
to participate in attractive and appropriate investment opportunities.
Applicants believe that the proposed terms and conditions will ensure
that the Co-Investment Transactions are consistent with the protection
of each Regulated Fund's shareholders and with the purposes intended by
the policies and provisions of the Act. Applicants state that the
Regulated Funds' participation in the Co-Investment Transactions will
be consistent with the provisions, policies, and purposes of the Act
and on a basis that is not different from or less advantageous than
that of other participants.

Applicants' Conditions

    Applicants agree that the Order will be subject to the following
conditions:
    1. Each time an Adviser considers a Potential Co-Investment
Transaction for an Affiliated Fund or another Regulated Fund that falls
within a Regulated Fund's then-current Objectives and Strategies, the
Regulated Fund's Adviser will make an independent determination of the
appropriateness of the investment for such Regulated Fund in light of
the Regulated Fund's then-current circumstances.
    2.(a) If the Adviser deems a Regulated Fund's participation in any
Potential Co-Investment Transaction to be appropriate for the Regulated
Fund, it will then determine an appropriate level of investment for the
Regulated Fund.
    (b) If the aggregate amount recommended by the applicable Adviser
to be invested by the applicable Regulated Fund in the Potential Co-
Investment Transaction, together with the amount proposed to be
invested by the other participating Regulated Funds and Affiliated
Funds, collectively, in the same transaction, exceeds the amount of the
investment opportunity, the investment opportunity will be allocated
among them pro rata based on each participant's ``capital available for
investment'' in the asset class being allocated, up to the amount
proposed to be invested by each. The applicable Adviser will provide
the Eligible Directors of each participating Regulated Fund with
information concerning each participating party's available capital to
assist the Eligible Directors with their review of the Regulated Fund's
investments for compliance with these allocation procedures.
    (c) After making the determinations required in conditions 1 and
2(a), the applicable Adviser will distribute written information
concerning the Potential Co-Investment Transaction (including the
amount proposed to be invested by each participating Regulated Fund and
Affiliated Fund) to the Eligible Directors of each participating
Regulated Fund for their consideration. A Regulated Fund will co-invest
with one or more other Regulated Funds and/or one or more Affiliated
Funds only if, prior to the Regulated Fund's participation in the
Potential Co-Investment Transaction, a Required Majority concludes
that:
    (i) The terms of the Potential Co-Investment Transaction, including
the consideration to be paid, are reasonable and fair to the Regulated
Fund and its shareholders and do not involve overreaching in respect of
the Regulated Fund or its shareholders on the part of any person
concerned;
    (ii) the Potential Co-Investment Transaction is consistent with:
    (A) The interests of the shareholders of the Regulated Fund; and
    (B) the Regulated Fund's then-current Objectives and Strategies;
    (iii) the investment by any other Regulated Funds or Affiliated
Funds would not disadvantage the Regulated Fund, and participation by
the Regulated Fund would not be on a basis different from or less
advantageous than that of other Regulated Funds or Affiliated Funds;
provided that, if any other Regulated Fund or Affiliated Fund, but not
the Regulated Fund itself, gains the right to nominate a director for
election to a portfolio company's board of directors, the right to have
a board observer or any similar right to participate in the governance
or management of the portfolio company, such event shall not be
interpreted to prohibit the Required Majority from reaching the
conclusions required by this condition (2)(c)(iii), if:
    (A) The Eligible Directors will have the right to ratify the
selection of such director, board observer or participant, if any;
    (B) the applicable Adviser agrees to, and does, provide periodic
reports to the Regulated Fund's Board with respect to the actions of
such director or the information received by such board observer or
obtained through the exercise of any similar right to participate in
the governance or management of the portfolio company; and
    (C) any fees or other compensation that any Affiliated Fund or any
Regulated Fund or any affiliated person of any Affiliated Fund or any
Regulated Fund receives in connection with the right of an Affiliated
Fund or a Regulated Fund to nominate a director or appoint a board
observer or otherwise to participate in the governance or management of
the portfolio company will be shared proportionately among the
participating Affiliated Funds (who each may, in turn, share its
portion with its affiliated persons) and the participating Regulated
Funds in accordance with the amount of each party's investment; and
    (iv) the proposed investment by the Regulated Fund will not benefit
the Adviser, the Affiliated Funds or the other Regulated Funds or any
affiliated person of any of them (other than the parties to the Co-
Investment Transaction), except (A) to the extent permitted by
condition 13, (B) to the extent permitted by section 17(e) of the Act,
(C) indirectly, as a result of an interest in the securities issued by
one of the parties to the Co-Investment Transaction, or (D) in the case
of fees or other compensation described in condition 2(c)(iii)(C).

    3. Each Regulated Fund has the right to decline to participate in
any Potential Co-Investment Transaction or to invest less than the
amount proposed.
    4. The applicable Adviser will present to the Board of each
Regulated Fund, on a quarterly basis, a record of all investments in
Potential Co-Investment Transactions made by any of the other Regulated
Funds or Affiliated Funds during the preceding quarter that fell within
the Regulated Fund's then-current Objectives and Strategies that were
not made available to the Regulated Fund, and an explanation of why the
investment opportunities were not offered to the Regulated Fund. All
information presented to the Board pursuant to this condition will be
kept for the life of the Regulated Fund and at least two years
thereafter, and will be subject to examination by the Commission and
its staff.
    5. Except for Follow-On Investments made in accordance with
condition 8,\9\ a Regulated Fund will not invest in reliance on the
Order in any issuer in which another Regulated Fund, Affiliated Fund,
or any affiliated person of another Regulated Fund or Affiliated Fund
is an existing investor.
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    \9\ This exception applies only to Follow-On Investments by a
Regulated Fund in issuers in which that Regulated Fund already holds
investments.
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    6. A Regulated Fund will not participate in any Potential Co-
Investment Transaction unless the terms, conditions, price, class of
securities to be purchased, settlement date, and registration rights
will be the same for each participating Regulated Fund and Affiliated
Fund. The grant to an Affiliated Fund or another Regulated Fund, but
not the Regulated Fund, of the right to nominate a director for
election to a portfolio company's board of directors, the right to have
an observer on the board of directors or similar rights to participate
in the governance or management of a portfolio company will not be
interpreted so as to violate this condition 6, if conditions
2(c)(iii)(A), (B) and (C) are met.
    7. (a) If any Affiliated Fund or any Regulated Fund elects to sell,
exchange or otherwise dispose of an interest in a security that was
acquired in a Co-Investment Transaction, the applicable Adviser will:
    (i) Notify each Regulated Fund that participated in the Co-
Investment Transaction of the proposed disposition at the earliest
practical time; and
    (ii) formulate a recommendation as to participation by each
Regulated Fund in the disposition.
    (b) Each Regulated Fund will have the right to participate in such
disposition on a proportionate basis, at the same price and on the same
terms and conditions as those applicable to the participating
Affiliated Funds and Regulated Funds.
    (c) A Regulated Fund may participate in such disposition without
obtaining prior approval of the Required Majority if: (i) The proposed
participation of each Regulated Fund and each Affiliated Fund in such
disposition is proportionate to its outstanding investments in the
issuer immediately preceding the disposition; (ii) the Board of the
Regulated Fund has approved as being in the best interests of the
Regulated Fund the ability to participate in such dispositions on a pro
rata basis (as described in greater detail in the application); and
(iii) the Board of the Regulated Fund is provided on a quarterly basis
with a list of all dispositions made in accordance with this condition.
In all other cases, the Adviser will provide its written recommendation
as to the Regulated Fund's participation to the Eligible Directors, and
the Regulated Fund will participate in such disposition solely to the
extent that a Required Majority determines that it is in the Regulated
Fund's best interests.
    (d) Each Affiliated Fund and each Regulated Fund will bear its own
expenses in connection with any such disposition.
    8.(a) If any Affiliated Fund or any Regulated Fund desires to make
a Follow-On Investment in a portfolio company whose securities were
acquired in a Co-Investment Transaction, the applicable Adviser will:
    (i) Notify each Regulated Fund that participated in the Co-
Investment Transaction of the proposed transaction at the earliest
practical time; and
    (ii) formulate a recommendation as to the proposed participation,
including the amount of the proposed Follow-On Investment, by each
Regulated Fund.
    (b) A Regulated Fund may participate in such Follow-On Investment
without obtaining prior approval of the Required Majority if: (i) The
proposed participation of each Regulated Fund and each Affiliated Fund
in such investment is proportionate to its outstanding investments in
the issuer immediately preceding the Follow-On Investment; and (ii) the
Board of the Regulated Fund has approved as being in the best interests
of the Regulated Fund the ability to participate in Follow-On
Investments on a pro rata basis (as described in greater detail in the
application). In all other cases, the Adviser will provide its written
recommendation as to the Regulated Fund's participation to the Eligible
Directors, and the Regulated Fund will participate in such Follow-On
Investment solely to the extent that a Required Majority determines
that it is in the Regulated Fund's best interests.
    (c) If, with respect to any Follow-On Investment:
    (i) The amount of the opportunity is not based on the Regulated
Funds' and the Affiliated Funds' outstanding investments immediately
preceding the Follow-On Investment; and
    (ii) the aggregate amount recommended by the Adviser to be invested
by each Regulated Fund in the Follow-On Investment, together with the
amount proposed to be invested by the participating Affiliated Funds in
the same transaction, exceeds the amount of the opportunity; then the
amount invested by each such party will be allocated among them pro
rata based on each participant's ``capital available for investment''
in the asset class being allocated, up to the amount proposed to be
invested by each.
    (d) The acquisition of Follow-On Investments as permitted by this
condition will be considered a Co-Investment Transaction for all
purposes and subject to the other conditions set forth in the
application.
    9. Each Regulated Fund will maintain the records required by
section 57(f)(3) of the Act as if each of the Regulated Funds was a
business development company and each of the investments permitted
under these conditions was approved by the Required Majority under
section 57(f).
    10. The Non-Interested Directors of each Regulated Fund will be
provided quarterly for review all information concerning Potential Co-
Investment Transactions and Co-Investment Transactions, including
investments made by other Regulated Funds or Affiliated Funds that the
Regulated Fund considered but declined to participate in, so that the
Non-Interested Directors may determine whether all investments made
during the preceding quarter, including those investments that the
Regulated Fund considered but declined to participate in, comply with
the conditions of the Order. In addition, the Non-Interested Directors
will consider at least annually the continued appropriateness for the
Regulated Fund of participating in new and existing Co-Investment
Transactions.
    11. No Non-Interested Director of a Regulated Fund will also be a
director, general partner, managing member or principal, or otherwise
an ``affiliated

person'' (as defined in the Act) of an Affiliated Fund.
    12. The expenses, if any, associated with acquiring, holding or
disposing of any securities acquired in a Co-Investment Transaction
(including, without limitation, the expenses of the distribution of any
such securities registered for sale under the 1933 Act) will, to the
extent not payable by the Adviser under its respective investment
advisory agreements with Affiliated Funds and the Regulated Funds, be
shared by the Regulated Funds and the Affiliated Funds in proportion to
the relative amounts of the securities held or to be acquired or
disposed of, as the case may be.
    13. Any transaction fee (including, without limitation, break-up or
commitment fees but excluding broker's fees contemplated by section
17(e) of the Act), received in connection with a Co-Investment
Transaction will be distributed to the participating Regulated Funds
and Affiliated Funds on a pro rata basis based on the amounts they
invested or committed, as the case may be, in such Co-Investment
Transaction. If any transaction fee is to be held by the Adviser
pending consummation of the transaction, the fee will be deposited into
an account maintained by the Adviser at a bank or banks having the
qualifications prescribed in section 26(a)(1) of the Act, and the
account will earn a competitive rate of interest that will also be
divided pro rata among the participating Regulated Funds and Affiliated
Funds based on the amounts they invest in such Co-Investment
Transaction. None of the Affiliated Funds, the Adviser, the other
Regulated Funds or any affiliated person of the Regulated Funds or
Affiliated Funds will receive additional compensation or remuneration
of any kind as a result of or in connection with a Co-Investment
Transaction (other than (a) in the case of the Regulated Funds and the
Affiliated Funds, the pro rata transaction fees described above and
fees or other compensation described in condition 2(c)(iii)(C); and (b)
in the case of the Adviser, investment advisory fees paid in accordance
with the agreement between the Adviser and the Regulated Fund or
Affiliated Fund.

    For the Commission, by the Division of Investment Management,
under delegated authority.
Brent J. Fields,
Secretary.
[FR Doc. 2015-03653 Filed 2-23-15; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 78, Number 207 (Friday, October 25, 2013)]
[Notices]
[Pages 63976-63977]
[FR Doc No: 2013-25048]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[ Docket No. CP14-5-000]

National Fuel Gas Supply Corporation; Notice of Request Under
Blanket Authorization

    Take notice that on October 11, 2013, National Fuel Gas Supply
Corporation (National Fuel), 6363 Main Street, Williamsville, New York
14221, filed in Docket No. CP14-5-000 a prior notice request pursuant
to sections 157.205 and 157.216 of the Commission's regulations under
the Natural Gas Act (NGA). National Fuel seeks authorization to abandon
an injection/withdrawal well in Boone Mountain Storage Field in Elk
County, Pennsylvania and 25 feet of associated pipeline. National Fuel
states that the abandonment is necessary due to the well's poor
performance and excessive cost of rehabilitation, and that the
abandonment will have no impact on its existing customers or its
storage operations, all as more fully set forth in the application
which is on file with the Commission and open to public inspection.
    The filing may be viewed on the Web at http://www.ferc.gov using
the ``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. For
assistance, contact FERC at<EMAIL_ADDRESS>or call toll-
free,<PHONE_NUMBER> or TYY,<PHONE_NUMBER>.
    Any questions regarding this application should be directed to
David W. Reitz, Deputy General Counsel for National Fuel Gas Supply
Corporation, 6363 Main Street, Williamsville, New York 14221, or call
(716) 857-7949.
    Any person or the Commission's Staff may, within 60 days after the
issuance of the instant notice by the Commission, file pursuant to Rule
214 of the Commission's Procedural Rules (18 CFR 385.214) a motion to
intervene or notice of intervention and, pursuant to section 157.205 of
the Commission's Regulations under the NGA (18 CFR 157.205) a protest
to the request. If no protest is filed within the time allowed
therefore, the proposed activity shall be deemed to be authorized
effective the day after the time allowed for protest. If a protest is
filed and not withdrawn within 30 days after the time allowed for
filing a protest, the instant request shall be treated as an
application for authorization pursuant to section 7 of the NGA.
    Pursuant to Section 157.9 of the Commission's rules, 18 CFR 157.9,
within 90 days of this Notice the Commission staff will either:
Complete its environmental assessment (EA) and place it into the
Commission's public record (eLibrary) for this proceeding, or issue a
Notice of Schedule for Environmental Review. If a Notice of Schedule
for Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission staff's issuance of
the final environmental impact statement (FEIS) or EA for this
proposal. The filing of the EA in the Commission's public record for
this proceeding or the issuance of a Notice of Schedule for
Environmental Review will serve to notify federal and state agencies of
the timing for the completion of all necessary reviews, and the
subsequent need to complete all federal authorizations within 90 days
of the date of issuance of the Commission staff's FEIS or EA.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commenters will be
placed on the Commission's environmental mailing list, will receive
copies of the environmental documents, and will be notified of meetings
associated with the Commission's environmental review process.
Environmental commenters will not be required to serve copies of filed
documents on all other parties. However, the non-party commenters will
not receive copies of all documents filed by other parties or issued by
the Commission (except for the mailing of environmental documents
issued by the

Commission) and will not have the right to seek court review of the
Commission's final order.
    The Commission strongly encourages electronic filings of comments,
protests, and interventions via the Internet in lieu of paper. See 18
CFR 385.2001(a) (1) (iii) and the instructions on the Commission's Web
site (www.ferc.gov) under the ``e-Filing'' link. Persons unable to file
electronically should submit an original and 7 copies of the protest or
intervention to the Federal Energy Regulatory Commission, 888 First
Street NE., Washington, DC 20426. See, 18 CFR 385.2001(a)(1)(iii) and
the instructions on the Commission's Web site under the ``e-Filing''
link.

    Dated: October 18, 2013.
Kimberly D. Bose,
Secretary.
[FR Doc. 2013-25048 Filed 10-24-13; 8:45 am]
BILLING CODE 6717-01-P


Comment Info: =================

General Comment:Dear Mr. Zeller:

I am contacting you to request an extension of the comment period for the Food and Drug Administration's ("FDA") Proposed Rule Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking and Prevention and Tobacco Control Act (the "Proposed Rule") published at 79 Fed. Reg. 23,142 and Federal Register No. 2014-09491. On behalf of myself, I am requesting that the comment period for the Proposed Rule be extended by the FDA for an additional 105 days, from its current 75-day period, to 180 days.

The Proposed Rule has a number of severe issues and questions that are important and effective to me, as a consumer of products that are proposed for regulation under the Proposed Rule. The Proposed Rule asks about a hundred different questions I want to respond to. I want to provide my thoughts and comments on many of these issues, but my time to devote to researching and providing thoughtful comments on these important questions is limited. I have already spent many hours researching and sorting out these issues, but they take time. I know that the FDA took many years to even come up with the Proposed Rule, so I do not think it is at all unreasonable to allow the public a mere six months to comment on it. This is our only opportunity, as consumers, to provide our feedback and concerns.

I feel very strongly about e-cigarettes as an alternative to traditional cigarettes. Basically, I strongly believe that they saved my life as well as a few family members and friends lives. I wish to provide you with my personal story, as well as science- and evidence-based responses to your questions so that you can take my comment into account. I realize that the FDA has the authority under 21 CFR 10.40 to extend this time frame and that the FDA has exercised this authority on numerous occasions in the past. I would therefore ask that you do so here, so that everyone can have the opportunity to provide their comments on this regulation.

I appreciate your consideration of my request and am happy to discuss this issue with you further. Sincerely,  Misty Robbins


[Federal Register Volume 76, Number 248 (Tuesday, December 27, 2011)]
[Notices]
[Pages 80923-80924]
[FR Doc No: 2011-32989]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. PR11-118-002]

Kansas Gas Service, a division of ONEOK, Inc.; Notice of
Compliance Filing

    Take notice that on December 16, 2011, Kansas Gas Service, a
division of ONEOK, Inc. filed a revised Statement of Operating
Conditions to comply with a Delegated letter order issued December 7,
2011.
    Any person desiring to participate in this rate filing 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). 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 date as indicated below. Anyone filing
an intervention or protest must serve a copy of that document on the
Applicant. Anyone filing an intervention or protest on or before the
intervention or protest date need not serve motions to intervene or
protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically

should submit an original and 7 copies of the protest or intervention
to the Federal Energy Regulatory Commission, 888 First Street NE.,
Washington, DC 20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the web site 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_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on Tuesday, January 3, 2012.

    Dated: December 19, 2011.
Kimberly D. Bose,
Secretary.
[FR Doc. 2011-32989 Filed 12-23-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 229 (Thursday, December 2, 2021)]
[Notices]
[Pages 68492-68493]
[FR Doc No: 2021-26284]

=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[CERCLA-02-2022-2004; FRL-9294-01-R2]

Proposed CERCLA Section 122(h) Settlement Agreement for the
Maywood Chemical Superfund Site, Boroughs of Maywood and Lodi, and the
Township of Rochelle Park, Bergen County, New Jersey

AGENCY: Environmental Protection Agency.

ACTION: Notice; request for public comment.

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

SUMMARY: In accordance with the Comprehensive Environmental Response,
Compensation and Liability Act of 1980, as amended (``CERCLA''), notice
is hereby given by the U.S. Environmental Protection Agency (``EPA''),
Region 2, of a proposed settlement agreement (``Agreement'') with Jeco
Corporation for the Maywood Chemical Superfund Site (``Site''),
Boroughs of Maywood and Lodi, and the Township of Rochelle Park, Bergen
County, New Jersey.

DATES: Comments must be submitted on or before January 3, 2022.

ADDRESSES: Comments can be sent via email to Kathryn DeLuca at
[email protected]. Comments should reference the Maywood Chemical
Superfund Site, CERCLA Section 122(h) Agreement, Index No. CERCLA-02-
2022-2004. The proposed settlement is available for public inspection
at this website: https://semspub.epa.gov/src/document/02/625503.

FOR FURTHER INFORMATION CONTACT: Kathryn DeLuca, Attorney, Office of
Regional Counsel, U.S. Environmental Protection Agency. Email:
[email protected]. Telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Under the proposed Agreement, Jeco
Corporation agrees to reimburse EPA for $125,500 in past and future
oversight costs incurred in connection with radiological contamination
at the property owned by Jeco Corporation that is part of the Site,
located at 149-151 Maywood Avenue, Borough of Maywood and Township of
Rochelle Park, Bergen County, New Jersey, designated as Block 124, Lot
30 in the Borough of Maywood and Block 17.02, Lot 1 in the Township of
Rochelle Park on the tax map of Bergen County, New Jersey (``Jeco
Property''). The Agreement also resolves EPA's Federal lien on the Jeco
Property arising under Section 107(l) of CERCLA, 42 U.S.C. 9607(1).

    For thirty (30) days following the date of publication of this
document, EPA will receive written comments relating to the proposed
Agreement. EPA will consider all comments received and may modify or
withdraw its consent to the proposed Agreement if comments received
disclose facts or considerations that indicate that the proposed
Agreement is inappropriate, improper, or inadequate. EPA's response to
any comments received will be available for public inspection online
and/or at EPA Region 2, 290 Broadway, New York, New York 10007-1866.

John Prince,
Acting Director, Superfund & Emergency Management Division,
Environmental Protection Agency, Region 2.
[FR Doc. 2021-26284 Filed 11-30-21; 4:15 pm]
BILLING CODE 6560-50-P


[Federal Register Volume 81, Number 144 (Wednesday, July 27, 2016)]
[Notices]
[Pages 49240-49242]
[FR Doc No: 2016-17730]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2016-0002; Internal Agency Docket No. FEMA-B-1633]

Changes in Flood Hazard Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This notice lists communities where the addition or
modification of Base Flood Elevations (BFEs), base flood depths,
Special Flood Hazard Area (SFHA) boundaries or zone designations, or
the regulatory floodway (hereinafter referred to as flood hazard
determinations), as shown on the Flood Insurance Rate Maps (FIRMs), and
where applicable, in the supporting Flood Insurance Study (FIS)
reports, prepared by the Federal Emergency Management Agency (FEMA) for
each community, is appropriate because of new scientific or technical
data. The FIRM, and where applicable, portions of the FIS report, have
been revised to reflect these flood hazard determinations through
issuance of a Letter of Map Revision (LOMR), in accordance with Title
44, Part 65 of the Code of Federal Regulations (44 CFR part 65). The
LOMR will be used by insurance agents and others to calculate
appropriate flood insurance premium rates for new buildings and the
contents of those buildings. For rating purposes, the currently
effective community number is shown in the table below and must be used
for all new policies and renewals.

DATES: These flood hazard determinations will become effective on the
dates listed in the table below and revise the FIRM panels and FIS
report in effect prior to this determination for the listed
communities.
    From the date of the second publication of notification of these
changes in a newspaper of local circulation, any person has 90 days in
which to request through the community that the Deputy Associate
Administrator for Insurance and Mitigation reconsider the changes. The
flood hazard determination information may be changed during the 90-day
period.

ADDRESSES: The affected communities are listed in the table below.
Revised flood hazard information for each community is available for
inspection at both the online location and the respective community map
repository address listed in the table below. Additionally, the current
effective FIRM and FIS report for each community are accessible online
through the FEMA Map Service Center at www.msc.fema.gov for comparison.
    Submit comments and/or appeals to the Chief Executive Officer of
the community as listed in the table below.

FOR FURTHER INFORMATION CONTACT: Rick Sacbibit, Chief, Engineering
Services Branch, Federal Insurance and Mitigation Administration, FEMA,
400 C Street SW., Washington, DC 20472,<PHONE_NUMBER>, or (email)
<EMAIL_ADDRESS>or visit the FEMA Map Information
eXchange (FMIX) online at www.floodmaps.fema.gov/fhm/fmx_main.html.

SUPPLEMENTARY INFORMATION: The specific flood hazard determinations are
not described for each community in this notice. However, the online
location and local community map repository address where the flood
hazard determination information is available for inspection is
provided.
    Any request for reconsideration of flood hazard determinations must
be submitted to the Chief Executive Officer of the community as listed
in the table below.
    The modifications are made pursuant to section 201 of the Flood
Disaster Protection Act of 1973, 42 U.S.C. 4105, and are in accordance
with the National Flood Insurance Act of 1968, 42 U.S.C. 4001 et seq.,
and with 44 CFR part 65.
    The FIRM and FIS report are the basis of the floodplain management
measures that the community is required either to adopt or to show
evidence of having in effect in order to qualify or remain qualified
for participation in the National Flood Insurance Program (NFIP).
    These flood hazard determinations, together with the floodplain
management criteria required by 44 CFR 60.3, are the minimum that are
required. They should not be construed to mean that the community must
change any existing ordinances that are more stringent in their
floodplain management requirements. The community may at any time enact
stricter requirements of its own or pursuant to policies established by
other Federal, State, or regional entities. The flood hazard
determinations are in accordance with 44 CFR 65.4.
    The affected communities are listed in the following table. Flood
hazard determination information for each community is available for
inspection at both the online location and the respective community map
repository address listed in the table below. Additionally, the current
effective FIRM and FIS report for each community are accessible online
through the FEMA Map Service Center at www.msc.fema.gov for comparison.

(Catalog of Federal Domestic Assistance No. 97.022, ``Flood
Insurance.'')

    Dated: June 20, 2016.
Roy E. Wright,
Deputy Associate Administrator for Insurance and Mitigation, Department
of Homeland Security, Federal Emergency Management Agency.

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

--------------------------------------------------------------------------------------------------------------------------------------------------------
Idaho: Ada....................  Unincorporated     Commissioner Dave  Ada County         http://            Mar. 9, 2016................          160001
                                 Areas of Ada       Case, Chairman,    Courthouse, 200    www.msc.fema.gov/
                                 County (15-10-     Board of           West Front         lomc.
                                 1460P).            Commissioners,     Street, Boise,
                                                    Ada County, 200    ID 83702.
                                                    West Front
                                                    Street, 3rd
                                                    Floor, Boise, ID
                                                    83702.
Illinois:
    Douglas...................  City of Tuscola    The Honorable      City Hall, 214     http://            Aug. 25, 2016...............          170195
                                 (16-05-0749P).     Daniel J.          North Main         www.msc.fema.gov/
                                                    Kleiss, Mayor,     Street, Tuscola,   lomc.
                                                    City of Tuscola,   IL 61953.
                                                    214 North Main
                                                    Street, Tuscola,
                                                    IL 61953.

    Douglas...................  Unincorporated     The Honorable Don  County             http://            Aug. 25, 2016...............          170194
                                 Areas of Douglas   Munson,            Courthouse, 401    www.msc.fema.gov/
                                 County (16-05-     Chairman,          South Center       lomc.
                                 0749P).            Douglas County     Street, Tuscola,
                                                    Board, Douglas     IL 61953.
                                                    County
                                                    Courthouse, P.O.
                                                    Box 467,
                                                    Tuscola, IL
                                                    61953.
    Peoria....................  City of Peoria     The Honorable Jim  Public Works       http://            Sept. 16, 2016..............          170536
                                 (15-05-6957P).     Ardis, Mayor,      Department, 3505   www.msc.fema.gov/
                                                    City of Peoria,    North Dries        lomc.
                                                    419 Fulton         Lane, Peoria, IL
                                                    Street, Suite      61604.
                                                    401, Peoria, IL
                                                    61602.
Iowa:
    Franklin..................  City of Sheffield  The Honorable      City Hall, 110     http://            Aug. 26, 2016...............          190132
                                 (16-07-1093X).     Nick Wilson,       South 3rd          www.msc.fema.gov/
                                                    Mayor, City of     Street,            lomc.
                                                    Sheffield, City    Sheffield, IA
                                                    Hall, 110 South    50475.
                                                    3rd Street, P.O.
                                                    Box 252,
                                                    Sheffield, IA
                                                    50475.
    Polk......................  City of Grimes     The Honorable      City Hall, 101     http://            Aug. 16, 2016...............          190228
                                 (15-07-2236P).     Thomas             North East         www.msc.fema.gov/
                                                    Armstrong,         Harvey Street,     lomc.
                                                    Mayor, City of     Grimes, IA 50111.
                                                    Grimes, City
                                                    Hall, 101
                                                    Northeast Harvey
                                                    Street, Grimes,
                                                    IA 50111.
    Polk......................  Unincorporated     Mr. Tom            Polk County        http://            Aug. 16, 2016...............          190901
                                 Areas of Polk      Hockensmith,       Public Works,      www.msc.fema.gov/
                                 County (15-07-     Board of           5885 North East    lomc.
                                 2236P).            Supervisors,       14th Street, Des
                                                    Polk County,       Moines, IA 50313.
                                                    Polk County
                                                    Administration
                                                    Building, 111
                                                    Court Avenue,
                                                    Suite 300, Des
                                                    Moines, IA 50309.
Missouri:
    St. Louis.................  City of            The Honorable Bob  City Hall, 690     http://            Aug. 19, 2016...............          290896
                                 Chesterfield (16-  Nation, Mayor,     Chesterfield       www.msc.fema.gov/
                                 07-0481P).         City of            Parkway West,      lomc.
                                                    Chesterfield,      Chesterfield, MO
                                                    690 Chesterfield   63017.
                                                    Parkway West,
                                                    Chesterfield, MO
                                                    63017.
    St. Louis.................  City of Wildwood   The Honorable      City Hall, 16860   http://            Aug. 19, 2016...............          290922
                                 (16-07-0481P).     Timothy            Main Street,       www.msc.fema.gov/
                                                    Woerther, Mayor,   Wildwood, MO       lomc.
                                                    City of            63040.
                                                    Wildwood, City
                                                    Hall, 16860 Main
                                                    Street,
                                                    Wildwood, MO
                                                    63040.
New Jersey: Passaic...........  Borough of         The Honorable      Bloomingdale       http://            Aug. 23, 2016...............          345284
                                 Bloomingdale (16-  Jonathan           Borough Hall,      www.msc.fema.gov/
                                 02-0098P).         Dunleavy, Mayor,   101 Hamburg        lomc.
                                                    Borough of         Turnpike,
                                                    Bloomingdale,      Bloomingdale, NJ
                                                    101 Hamburg        07403.
                                                    Turnpike,
                                                    Bloomingdale, NJ
                                                    07403.
Ohio:
    Lucas.....................  City of Oregon     The Honorable      City Hall, 5330    http://            Sep. 13, 2016...............          390361
                                 (16-05-1552P).     Michael J.         Seaman Road,       www.msc.fema.gov/
                                                    Seferian, Mayor,   Oregon, OH 43616.  lomc.
                                                    City of Oregon,
                                                    5330 Seaman
                                                    Road, Oregon, OH
                                                    43616.
    Tuscarawas................  Village of Zoar    The Honorable      County             http://            Sep. 9, 2016................          390752
                                 (16-05-2633P).     Scott Gordon,      Administrative     www.msc.fema.gov/
                                                    Mayor, Village     Offices, 125       lomc.
                                                    of Zoar, 250       East High
                                                    North Main         Avenue, New
                                                    Street, P.O. Box   Philadelphia, OH
                                                    544, Zoar, OH      44663.
                                                    44697.
    Warren....................  Unincorporated     The Honorable Pat  Warren County      http://            Aug. 29, 2016...............          390757
                                 Areas of Warren    South,             Administration     www.msc.fema.gov/
                                 County (15-05-     Chairperson,       Building, 406      lomc.
                                 6683P).            Warren County      Justice Drive,
                                                    Board of County    Room 167,
                                                    Commissioners,     Lebanon, OH
                                                    406 Justice        45036.
                                                    Drive, 1st
                                                    Floor, Lebanon,
                                                    OH 45036.
Oregon:
    Jackson...................  City of Central    The Honorable      City of Central    http://            Sep. 14, 2016...............          410092
                                 Point (16-10-      Hank Williams,     Point, 140 South   www.msc.fema.gov/
                                 0502P).            Mayor, City of     3rd Street,        lomc.
                                                    Central Point,     Central Point,
                                                    140 South 3rd      OR 97502.
                                                    Street, Central
                                                    Point, OR 97502.
    Jackson...................  Unincorporated     Mr. Don            Jackson County     http://            Sep. 14, 2016...............          415589
                                 Areas of Jackson   Skundrick,         Roads, Parks and   www.msc.fema.gov/
                                 County (16-10-     Jackson County     Planning           lomc.
                                 0502P).            Commissioner, 10   Services, 10
                                                    South Oakdale      South Oakdale
                                                    Avenue, Room       Avenue, Medford,
                                                    100, Medford, OR   OR 97501.
                                                    97501.
Texas:

    Dallas....................  City of Grand      The Honorable Ron  City Development   http://            Sep. 12, 2016...............          485472
                                 Prairie (16-06-    Jensen, Mayor,     Center, 206 West   www.msc.fema.gov/
                                 1079P).            City of Grand      Church Street,     lomc.
                                                    Prairie, 317       Grand Prairie,
                                                    West College       TX 75050.
                                                    Street, P.O. Box
                                                    534045, Grand
                                                    Prairie, TX
                                                    75053.
    Dallas....................  City of Irving     The Honorable      Public Works       http://            Sep. 12, 2016...............          480180
                                 (16-06-1079P).     Beth Van Duyne,    Department, 825    www.msc.fema.gov/
                                                    Mayor, City of     West Irving        lomc.
                                                    Irving, 825 West   Boulevard,
                                                    Irving             Irving, TX 75060.
                                                    Boulevard,
                                                    Irving, TX 75060.
Washington: Spokane...........  Unincorporated     The Honorable      Public Works       http://            Aug. 26, 2016...............          530174
                                 Areas of Spokane   Nancy              Building, 1026     www.msc.fema.gov/
                                 County (16-10-     McLaughlin,        West Broadway      lomc.
                                 0312P).            County             Avenue, Spokane,
                                                    Commissioner,      WA 99260.
                                                    Spokane County,
                                                    Spokane County
                                                    Courthouse, 1116
                                                    West Broadway
                                                    Avenue, Spokane,
                                                    WA 99260.
Wisconsin:
    Dane......................  City of Madison    The Honorable      City Hall, 210     http://            Sep. 14, 2016...............          550083
                                 (16-05-1781P).     Paul R. Soglin,    Martin Luther      www.msc.fema.gov/
                                                    Mayor, City of     King Jr.           lomc.
                                                    Madison, Mayor's   Boulevard, Room
                                                    Office, 210        403, Madison, WI
                                                    Martin Luther      53703.
                                                    King Jr.
                                                    Boulevard, Room
                                                    403, Madison, WI
                                                    53703.
    Dane......................  Unincorporated     The Honorable Joe  City-County        http://            Sep. 14, 2016...............          550077
                                 Areas of Dane      Parisi, Dane       Building, 210      www.msc.fema.gov/
                                 County (16-05-     County             Martin Luther      lomc.
                                 1781P).            Executive, City-   King Jr.
                                                    County Building,   Boulevard, Room
                                                    210 Martin         116, Madison, WI
                                                    Luther King Jr.    53703.
                                                    Boulevard, Room
                                                    421, Madison, WI
                                                    53703.
    Milwaukee.................  City of Milwaukee  The Honorable Tom  City Hall, 200     http://            Sep. 23, 2016...............          550278
                                 (16-05-0269P).     Barrett, Mayor,    East Wells         www.msc.fema.gov/
                                                    City of            Street,            lomc.
                                                    Milwaukee, 200     Milwaukee, WI
                                                    East Wells         53202.
                                                    Street, Room
                                                    201, Milwaukee,
                                                    WI 53202.
    Milwaukee.................  City of Oak Creek  The Honorable      City Hall, 8640    http://            Sep. 23, 2016...............          550279
                                 (16-05-0269P).     Stephen            South Howell       www.msc.fema.gov/
                                                    Scaffidi, Mayor,   Avenue, Oak        lomc.
                                                    City of Oak        Creek, WI 53154.
                                                    Creek, 8040
                                                    South 6th
                                                    Street, Oak
                                                    Creek, WI 53154.
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[FR Doc. 2016-17730 Filed 7-26-16; 8:45 am]
BILLING CODE 9110-12-P


[Federal Register Volume 76, Number 121 (Thursday, June 23, 2011)]
[Notices]
[Pages 36911-36912]
[FR Doc No: 2011-15697]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2743-071]

Kodiak Electric Association, Inc.; Notice of Application Accepted
for Filing, Ready for Environmental Analysis, Soliciting Comments,
Motions To Intervene, Protests, Recommendations, Terms and Conditions,
and Fishway Prescriptions

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:
    a. Type of Application: Amendment of License.
    b. Project No.: 2743-071.
    c. Date Filed: May 20, 2011.
    d. Applicant: Kodiak Electric Association, Inc.
    e. Name of Project: Terror Lake Project.
    f. Location: The project is located on the Terror and Kizhuyak
Rivers in Kodiak Island Borough, Alaska. The project occupies federal
lands managed by the U.S. Fish and Wildlife Service within the Kodiak
National Wildlife Refuge and on lands managed by the U.S. Coast Guard.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791a-825r.
    h. Applicant Contact: Darron Scott, President/CEO, Kodiak Electric
Association, Inc. P.O. Box 787, Kodiak, AK 99615-0787,<PHONE_NUMBER>.
    i. FERC Contact: Mr. Steven Sachs<PHONE_NUMBER> or
<EMAIL_ADDRESS>    j. Deadline for filing motions to intervene and protests, comments,
recommendations, terms and conditions, and fishway prescriptions is 60
days from the issuance date of this notice; reply comments are due 105
days from the issuance date of this notice.
    All documents may be filed electronically via the Internet. See, 18
CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web
site at http://www.ferc.gov/docs-filing/efiling.asp. If unable to be
filed electronically, documents may be paper-filed. To paper-file, an
original and seven copies should be mailed to: Secretary, Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426. Commenters can submit brief comments up to 6,000 characters,
without prior registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and
contact information at the end of your comments.
    Please include the project number (P-2743-071) on any comments,
motions, recommendations, or terms and conditions filed.
    k. Description of Request: The applicant proposes to install a
third turbine-generator unit at the project. The new unit would have an
installed capacity of 11.25 megawatts (MW) and be contained entirely
within the project's powerhouse. The proposal would increase the
hydraulic capacity of the project from 300 to 435 cubic feet per second
and the authorized installed capacity from 22.5 to 33.75 MW. Because
the project was constructed with provisions for the third unit, no
significant modifications to conduits, structures, or electrical
equipment would be required.
    l. Locations of the Application: A copy of the application is
available for inspection and reproduction at the Commission's Public
Reference Room, located at 888 First Street, NE., Room 2A, Washington,
DC 20426, or by calling<PHONE_NUMBER>. This filing may also be viewed
on the Commission's Web site at http://www.ferc.gov/docs-filing/efiling.asp. Enter the docket number excluding the last three digits in
the docket number field to access the document. You may also register
online at http://www.ferc.gov/docs-filing/esubscription.asp to be
notified via e-mail of new filings and issuances related to this or
other pending projects. For assistance, call 1-866-208-3676 or e-mail
<EMAIL_ADDRESS>for TTY, call<PHONE_NUMBER>. A copy is
also available for inspection and reproduction at the address in item
(h) above.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Protests, or Motions To Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214. In determining the appropriate action to take, the Commission
will consider all protests or other comments filed, but only those who
file a motion to intervene in accordance with the Commission's Rules
may become a party to the proceeding. Any comments, protests, or
motions to intervene must be received on or before the specified
comment date for the particular application.
    o. Filing and Service of Responsive Documents: All filings must (1)
Bear in all capital letters the title

``COMMENTS'', ``PROTEST'', ``MOTION TO INTERVENE'', ``TERMS AND
CONDITIONS'' or ``FISHWAY PRESCRIPTIONS'' as applicable; (2) set forth
in the heading the name of the applicant and the project number of the
application to which the filing responds; (3) furnish the name,
address, and telephone number of the person protesting or intervening;
and (4) otherwise comply with the requirements of 18 CFR 385.2001
through 385.2005. All comments, motions to intervene, or protests must
set forth their evidentiary basis and otherwise comply with the
requirements of 18 CFR 4.34(b). All comments, motions to intervene, or
protests should relate to project works which are the subject of the
amendment. Agencies may obtain copies of the application directly from
the applicant. A copy of any protest or motion to intervene must be
served upon each representative of the applicant specified in the
particular application. If an intervener files comments or documents
with the Commission relating to the merits of an issue that may affect
the responsibilities of a particular resource agency, they must also
serve a copy of the document on that resource agency. A copy of all
other filings in reference to this application must be accompanied by
proof of service on all persons listed in the service list prepared by
the Commission in this proceeding, in accordance with 18 CFR 4.34(b)
and 385.2010.
    p. As provided for in 18 CFR 4.34(b)(5)(i), a license applicant
must file, no later than 60 days following the date of issuance of this
notice of acceptance and ready for environmental analysis: (1) A copy
of the water quality certification; (2) a copy of the request for
certification, including proof of the date on which the certifying
agency received the request; or (3) evidence of waiver of water quality
certification.

    Dated: June 16, 2011.
Kimberly D. Bose,
Secretary.
[FR Doc. 2011-15697 Filed 6-22-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 78, Number 32 (Friday, February 15, 2013)]
[Notices]
[Page 11170]
[FR Doc No: 2013-03499]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 3267-015]

North Country Community College Foundation, Inc., Chasm Hydro,
Inc.; Notice of Application for Transfer of License, and Soliciting
Comments and Motions To Intervene

    On January 31, 2013, North Country Community College Foundation,
Inc. (transferor) and Chasm Hydro, Inc. (transferee) filed an
application for the transfer of license for the Ballard Mill Project
(FERC No. 3267), located on the Salmon River in Franklin County, New
York.
    Applicants seek Commission approval to transfer the license for the
Ballard Mill Project from the transferor to the transferee.
    Applicants' Contact: Transferor: Ms. Diana Fortune, Director of
Development and Ms. Susanna R. Cantwell, President, North Country
Community College Foundation, Inc., 23 Santanoni Avenue, P.O. Box 89,
Saranac Lake, NY 12983, telephone<PHONE_NUMBER>. Transferee: Mr. John
Dowd, President, Chasm Hydro, Inc., 7063 State Route 374, Chateaugay,
NY 12920, telephone<PHONE_NUMBER>.
    FERC Contact: Patricia W. Gillis<PHONE_NUMBER>,
<EMAIL_ADDRESS>    Deadline for filing comments and motions to intervene: 30 days from
the issuance date of this notice. Comments and motions to intervene may
be filed electronically via the Internet. See 18 CFR 385.2001(a)(1) and
the instructions on the Commission's Web site under http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit brief
comments up to 6,000 characters, without prior registration, using the
eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You
must include your name and contact information at the end of your
comments. If unable to be filed electronically, documents may be paper-
filed. To paper-file, an original plus seven copies should be mailed
to: Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission,
888 First Street NE., Washington, DC 20426. More information about this
project can be viewed or printed on the eLibrary link of Commission's
Web site at http://www.ferc.gov/docs-filing/elibrary.asp. Enter the
docket number (P-3267) in the docket number field to access the
document. For assistance, call toll-free 1-866-208-3372.

    Dated: February 8, 2013.
Kimberly D. Bose,
Secretary.
[FR Doc. 2013-03499 Filed 2-14-13; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 20 (Monday, January 31, 2022)]
[Notices]
[Pages 4897-4898]
[FR Doc No: 2022-01858]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-0008]

Advisory Committee; Vaccines and Related Biological Products
Advisory Committee; Renewal

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; renewal of Federal advisory committee.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing the renewal of the Vaccines and Related Biological Products
Advisory Committee by the Commissioner of Food and Drugs (the
Commissioner). The Commissioner has determined that it is in the public
interest to renew the Vaccines and Related Biological Products Advisory
Committee for an additional 2 years beyond the charter expiration date.
The new charter will be in effect until the December 31, 2023,
expiration date.

DATES: Authority for the Vaccines and Related Biological Products
Advisory Committee will expire on December 31, 2023, unless the
Commissioner formally determines that renewal is in the public
interest.

FOR FURTHER INFORMATION CONTACT: Prabhakara Atreya, Division of
Scientific Advisors and Consultants, Center for Biologics Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 71, Rm. 6306, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: Pursuant to 41 CFR 102-3.65 and approval by
the Department of Health and Human Services and by the General Services
Administration, FDA is announcing the renewal of the Vaccines and
Related Biological Products Advisory Committee (the Committee). The
Committee is a discretionary Federal advisory committee established to
provide advice to the Commissioner. The Committee advises the
Commissioner or designee in discharging responsibilities as they relate
to helping to ensure safe and effective vaccines and related biological
products for human use and, as required, any other product for which
FDA has regulatory responsibility.
    The Committee reviews and evaluates data concerning the safety,
effectiveness, and appropriate use of vaccines and related biological
products which are intended for use in the prevention, treatment, or
diagnosis of human diseases, and, as required, any other products for
which FDA has regulatory responsibility. The Committee also considers
the quality and relevance of FDA's research program, which provides
scientific support for the regulation of these products and makes
appropriate recommendations to the Commissioner.
    The Committee shall consist of a core of 15 voting members,
including the Chairperson (the Chair). Members and the Chair are
selected by the Commissioner or designee from among authorities
knowledgeable in the fields of immunology, molecular biology, rDNA,
virology, bacteriology, epidemiology or biostatistics, vaccine policy,
vaccine safety science, federal immunization activities, vaccine
development including translational and clinical evaluation programs,
allergy, preventive medicine, infectious diseases, pediatrics,
microbiology, and biochemistry. Members will be invited to serve for
overlapping terms of up to 4 years. Almost all non-Federal members of
this committee serve as Special Government Employees. Ex Officio voting
members, one each from the Department of Health and Human Services, the
Centers for Disease Control and Prevention, and the National Institutes
of Health may be included. The core of voting members may include one
technically qualified member, selected by the Commissioner or designee,
who is identified with consumer interests and is recommended by either
a consortium of consumer-oriented organizations or other interested
persons. In addition to the voting members, the Committee may include
one non-voting member who is identified with industry interests. There
may also be an alternate industry representative.
    The Commissioner or designee shall have the authority to select
members of other scientific and technical FDA advisory committees
(normally not to exceed 10 members) to serve temporarily as voting
members and to designate consultants to serve temporarily as voting
members when: (1) Expertise is required that is not available among
current voting standing

members of the Committee (when additional voting members are added to
the Committee to provide needed expertise, a quorum will be based on
the combined total of regular and added members) or (2) to comprise a
quorum when, because of unforeseen circumstances, a quorum is or will
be lacking. Because of the size of the Committee and the variety in the
types of issues that it will consider, FDA may, in connection with a
particular committee meeting, specify a quorum that is less than a
majority of the current voting members. The Agency's regulations (21
CFR 14.22(d)) authorize a committee charter to specify quorum
requirements.
    If functioning as a medical device panel, a non-voting
representative of consumer interests and a non-voting representative of
industry interests will be included in addition to the voting members.
    Further information regarding the most recent charter and other
information can be found at https://www.fda.gov/advisory-committees/vaccines-and-related-biological-products-advisory-committee/charter-vaccines-and-related-biological-products-advisory-committee or by
contacting the Designated Federal Officer (see FOR FURTHER INFORMATION
CONTACT). In light of the fact that no change has been made to the
committee name or description of duties, no amendment will be made to
21 CFR 14.100.
    This document is issued under the Federal Advisory Committee Act (5
U.S.C. app.). For general information related to FDA advisory
committees, please visit us at https://www.fda.gov/AdvisoryCommittees/default.htm.

    Dated: January 24, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-01858 Filed 1-28-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 86, Number 3 (Wednesday, January 6, 2021)]
[Notices]
[Pages 553-554]
[FR Doc No: 2020-29291]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4447-DR; [Docket ID FEMA-2020-0001]

Ohio; Amendment No. 3 to Notice of a Major Disaster Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Ohio (FEMA-4447-DR), dated June 18, 2019, and related
determinations.

DATES: This change occurred on December 28, 2020.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and

Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency
(FEMA) hereby gives notice that pursuant to the authority vested in the
Administrator, under Executive Order 12148, as amended, Joseph Cirone,
of FEMA is appointed to act as the Federal Coordinating Officer for
this disaster.
    This action terminates the appointment of Steven W. Johnson as
Federal Coordinating Officer for this disaster.

The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households In
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050, Presidentially Declared Disaster
Assistance to Individuals and Households--Other Needs; 97.036,
Disaster Grants--Public Assistance (Presidentially Declared
Disasters); 97.039, Hazard Mitigation Grant.

Pete Gaynor,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2020-29291 Filed 1-5-21; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 87, Number 184 (Friday, September 23, 2022)]
[Notices]
[Pages 58116-58117]
[FR Doc No: 2022-20634]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2020-E-2364 and FDA-2020-E-2365]

Determination of Regulatory Review Period for Purposes of Patent
Extension; NURTEC ODT

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for NURTEC ODT and is
publishing this notice of that determination as required by law. FDA
has made the determination because of the submission of an application
to the Director of the U.S. Patent and Trademark Office (USPTO),
Department of Commerce, for the extension of a patent which claims that
human drug product.

DATES: Anyone with knowledge that any of the dates as published (see
SUPPLEMENTARY INFORMATION) are incorrect must submit either electronic
or written comments and ask for a redetermination by November 22, 2022.
Furthermore, any interested person may petition FDA for a determination
regarding whether the applicant for extension acted with due diligence
during the regulatory review period by March 22, 2023. See
``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of November 22, 2022. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket Nos.
FDA-2020-E-2364 and FDA-2020-E-2365 for ``Determination of Regulatory
Review Period for Purposes of Patent Extension; NURTEC ODT.'' Received
comments, those filed in a timely manner (see ADDRESSES), will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with Sec.  10.20 (21 CFR 10.20) and
other applicable disclosure law. For more information about FDA's
posting of comments to public dockets, see 80 FR 56469, September 18,
2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket numbers, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug or biologic product, animal drug product, medical device,
food additive, or color additive) was subject to regulatory review by
FDA before the item was marketed. Under these acts, a product's
regulatory review period forms the basis for determining the amount of
extension an applicant may receive.

    A regulatory review period consists of two periods of time: a
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug product becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of USPTO may award
(for example, half the testing phase must be subtracted as well as any
time that may have occurred before the patent was issued), FDA's
determination of the length of a regulatory review period for a human
drug product will include all of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human drug product, NURTEC ODT
(rimegepant sulfate). NURTEC ODT is indicated for the acute treatment
of migraine with or without aura in adults. Subsequent to this
approval, the USPTO received a patent term restoration application for
NURTEC ODT (U.S. Patent Nos. 8,314,117 and 8,759,372) from Biohaven
Pharmaceutical Holding Company Ltd. and the USPTO requested FDA's
assistance in determining the patents' eligibility for patent term
restoration. In a letter dated March 1, 2021, FDA advised the USPTO
that this human drug product had undergone a regulatory review period
and that the approval of NURTEC ODT represented the first permitted
commercial marketing or use of the product. Thereafter, the USPTO
requested that FDA determine the product's regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
NURTEC ODT is 3,390 days. Of this time, 3,144 days occurred during the
testing phase of the regulatory review period, while 246 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective:
November 18, 2010. The applicant claims November 20, 2010, as the date
the investigational new drug application (IND) became effective.
However, FDA records indicate that the IND effective date was November
18, 2010, which was 30 days after FDA receipt of the IND.
    2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the FD&C Act: June 27,
2019. FDA has verified the applicant's claim that the new drug
application (NDA) for NURTEC ODT (NDA 212728) was initially submitted
on June 27, 2019.
    3. The date the application was approved: February 27, 2020. FDA
has verified the applicant's claim that NDA 212728 was approved on
February 27, 2020.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its applications for patent extension,
this applicant seeks 368 days or 1,102 days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec.  60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec.  60.30, including but not limited to: must be timely (see
DATES), must be filed in accordance with Sec.  10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42,
1984.) Petitions should be in the format specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: September 19, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-20634 Filed 9-22-22; 8:45 am]
BILLING CODE 4164-01-P