[Federal Register Volume 81, Number 90 (Tuesday, May 10, 2016)]
[Notices]
[Pages 28910-28915]
[FR Doc No: 2016-10960]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. IC-32106; File No. 812-14429]

Triloma EIG Global Energy Fund, et al.; Notice of Application

May 5, 2016.
AGENCY: Securities and Exchange Commission (``Commission'').

ACTION: Notice of application for an order under sections 17(d) and
57(i) of the Investment Company Act of 1940 (the ``Act'') and rule 17d-
1 under the Act to permit certain joint transactions otherwise
prohibited by sections 17(d) and 57(a)(4) of the Act and rule 17d-1
under the Act.

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Summary of Application: Applicants request an order to permit certain
business development companies (``BDC'') and closed-end management
investment companies to co-invest in portfolio companies with each
other and with affiliated investment funds.

Applicants: Triloma EIG Global Energy Fund (the ``Perpetual Fund''),
Triloma EIG Global Energy Term Fund I (the ``Term Fund'' and, together
with the Perpetual Fund, the ``Existing Regulated Entities''); Triloma
Energy Advisors, LLC (``Triloma''); EIG Credit Management Company, LLC
(``EIG''); EIG Asset Management, LLC, EIG Funds Management, LLC, EIG
Management Company, LLC, EIG Global Energy (Asia) Limited, EIG Harbour
Energy Advisor, L.P. (collectively, together with EIG, the ``Existing
EIG Advisors''); EIG-Gateway Direct Investments, L.P., EIG Energy Fund
XVI, L.P., EIG Energy Fund XVI-B, L.P., EIG Energy Fund XVI-E, L.P.,
EIG Energy Fund XVI (Cayman), L.P., EIG Energy Fund XVI (Scotland),
L.P., EIG-Keats Energy Partners, L.P., EIG Global Private Debt Fund-A,
L.P., EIG Global Private Debt Fund-A (UL), L.P., EIG Global Private
Debt Sub Fund-B, L.P., EIG Global Private Debt Sub B (UL), L.P., EIG
Global Private Debt Finco-B, LLC, EIG Global Private Debt Finco-B (UL),
LLC, and Harbour Energy Ltd. (collectively, the ``Existing Affiliated
Investors'').

Filing Dates: The application was filed on March 6, 2015, and amended
on November 12, 2015, February 24, 2016, and April 29, 2016.

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 May 27, 2016, and should be accompanied by proof of
service on applicants, in the form of an affidavit or, for lawyers, a
certificate of service. Pursuant to rule 0-5 under the Act, hearing
requests should state the nature of the writer's interest, any facts
bearing upon the desirability of a hearing on the matter, 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: Triloma and the
Existing Regulated Entities: 201 N. New York Avenue, Suite 250, Winter
Park, FL 32789; the Existing EIG Advisors and the Existing Affiliated
Investors: 1700 Pennsylvania Ave. NW., Suite 800, Washington, DC 20006.

FOR FURTHER INFORMATION CONTACT: Robert Shapiro, Senior Counsel, at
(202) 551-7758 or Mary Kay Frech, 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. Term Fund was organized under the Delaware Statutory Trust Act
for the purpose of operating as an externally-managed, non-diversified,
closed-end management investment company. Term Fund is a registered
investment company under the Act. Term Fund's Objectives and Strategies
\1\ are to provide shareholders with current income, capital
preservation and, to a lesser extent, long-term capital appreciation by
investing primarily in a global portfolio of privately originated
energy company and project debt. Term Fund has a five member Board,\2\
of which three members are Independent Trustees,\3\ one member is
considered an ``interested person'' of Triloma, within the meaning of
section 2(a)(19) of the Act, and one member is considered an
``interested person'' of EIG.
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    \1\ ``Objectives and Strategies'' means a Regulated Entity's (as
defined below) investment objectives and strategies, as described in
the Regulated Entity's registration statement on Form N-2, other
filings the Regulated Entity 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 Entity's reports
to shareholders.
    \2\ The term ``Board'' refers to the board of directors or
trustees of any Regulated Entity.
    \3\ The term ``Independent Trustees'' refers to the trustees or
directors of any Regulated Entity that are not ``interested
persons'' of the Regulated Entity within the meaning of section
2(a)(19) of the Act.
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    2. Perpetual Fund was organized under the Delaware Statutory Trust
Act for the purpose of operating as an externally-managed, non-
diversified, closed-end management investment company. Perpetual Fund
is a registered investment company under the Act. Perpetual Fund has
the same Objectives and Strategies as Term Fund. Perpetual Fund will be
governed by a Board comprised of the same trustees (including
Independent Trustees) that serve as the Board of Term Fund.
    3. Triloma is a Florida limited liability company and is registered
as an investment adviser under the Investment Advisers Act of 1940 (the
``Advisers Act''). Triloma serves as the investment adviser to the
Existing Regulated Entities. Triloma also provides administrative
services to the Existing Regulated Entities under an administrative
services agreement.
    4. EIG is a Delaware limited liability company and is registered as
an investment adviser under the Advisers Act. EIG serves as the sub-
adviser to the Existing Regulated Entities. EIG is an indirectly owned
subsidiary of EIG Global Energy Partners, LLC (``EIG Partners'').
    5. Each Existing Affiliated Investors is a privately-offered fund
that would be an investment company but for section 3(c)(1) or 3(c)(7)
of the Act. An Existing EIG Advisor serves as the investment adviser to
each Existing Affiliated Investor. Each Existing EIG Advisor is either,
directly or indirectly, controlled by EIG Partners or under common
control with EIG and is registered as an investment adviser under the
Advisers Act.
    6. Applicants seek an order (``Order'') to permit one or more
Regulated Entities \4\ and/or one or more Affiliated

Investors \5\ 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
sections 17(d) and 57(a)(4) and the rules under the Act. For purposes
of the application, ``Co-Investment Transaction'' means any transaction
in which a Regulated Entity (or its Wholly-Owned Investment Subsidiary,
as defined below) participated together with one or more other
Regulated Entities and/or one or more Affiliated Investors in reliance
on the requested Order. ``Potential Co-Investment Transaction'' means
any investment opportunity in which a Regulated Entity (or its Wholly-
Owned Investment Subsidiary) could not participate together with one or
more Affiliated Investors and/or one or more other Regulated Entities
without obtaining and relying on the Order.\6\ The term ``Advisor''
means any Triloma Advisor or any EIG Advisor.
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    \4\ ``Regulated Entity'' means any of the Existing Regulated
Entities and any Future Regulated Entity. ``Future Regulated
Entity'' means a closed-end management investment company (a) that
is registered under the Act or has elected to be regulated as a BDC
under the Act, (b) whose investment adviser is a Triloma Advisor and
(c) whose investment sub-adviser is an EIG Advisor. ``Triloma
Advisor'' means Triloma or any future investment adviser that (i)
controls, is controlled by or is under common control with Triloma,
(ii) is registered as an investment adviser under the Advisers Act
and (iii) is not a Regulated Entity or a subsidiary of a Regulated
Entity. ``EIG Advisor'' means any Existing EIG Advisor or any future
investment adviser that (i) controls, is controlled by or is under
common control with EIG, (ii) is registered as an investment adviser
under the Advisers Act, and (iii) is not a Regulated Entity or a
subsidiary of a Regulated Entity.
    \5\ ``Affiliated Investors'' means the Existing Affiliated
Investors and any Future Affiliated Investor. ``Future Affiliated
Investor'' means an entity (a) whose investment adviser is an EIG
Advisor and (b) that would be an investment company but for section
3(c)(1) or 3(c)(7) of the Act.
    \6\ 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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    7. Applicants state that a Regulated Entity may, from time to time,
form a Wholly-Owned Investment Subsidiary.\7\ Such a subsidiary would
be prohibited from investing in a Co-Investment Transaction with any
Affiliated Investor because it would be a company controlled by its
parent Regulated Entity for purposes of section 57(a)(4) and rule 17d-
1. Applicants request that each Wholly-Owned Investment Subsidiary be
permitted to participate in Co-Investment Transactions in lieu of its
parent Regulated Entity and that the Wholly-Owned Investment
Subsidiary's participation in any such transaction be treated, for
purposes of the requested Order, as though the parent Regulated Entity
were participating directly. Applicants represent that this treatment
is justified because a Wholly-Owned Investment Subsidiary would have no
purpose other than serving as a holding vehicle for the Regulated
Entity's investments and, therefore, no conflicts of interest could
arise between the Regulated Entity and the Wholly-Owned Investment
Subsidiary. The Regulated Entity's Board would make all relevant
determinations under the conditions with regard to a Wholly-Owned
Investment Subsidiary's participation in a Co-Investment Transaction,
and the Regulated Entity's Board would be informed of, and take into
consideration, any proposed use of a Wholly-Owned Investment Subsidiary
in the Regulated Entity's place. If the Regulated Entity proposes to
participate in the same Co-Investment Transaction with any of its
Wholly-Owned Investment Subsidiaries, the Board will also be informed
of, and take into consideration, the relative participation of the
Regulated Entity and the Wholly-Owned Investment Subsidiary.
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    \7\ The term ``Wholly-Owned Investment Subsidiary'' means an
entity (i) that is wholly-owned by a Regulated Entity (with such
Regulated Entity 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 on behalf of the
Regulated Entity (and, in the case of an entity that is licensed by
the Small Business Administration to operate under the Small
Business Investment Act of 1958, as amended (the ``SBA Act''), as a
small business investment company (an ``SBIC''), to maintain a
license under the SBA Act and issue debentures guaranteed by the
Small Business Administration); (iii) with respect to which the
Regulated Entity's Board 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. All
subsidiaries participating in the Co-Investment Program will be
Wholly-Owned Investment Subsidiaries and will have Objectives and
Strategies that are either substantially the same as, or a subset
of, their parent Regulated Entity's Objectives and Strategies. A
subsidiary that is an SBIC may be a Wholly-Owned Investment
Subsidiary if it satisfies the conditions in this definition.
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    8. It is anticipated that an EIG Advisor will periodically
determine that certain investments the EIG Advisor recommends for a
Regulated Entity would also be appropriate investments for one or more
other Regulated Entities and/or one or more Affiliated Investors. Such
a determination may result in the Regulated Entity, one or more other
Regulated Entities and/or one or more Affiliated Investors co-investing
in certain investment opportunities. For each such investment
opportunity, the Advisors to each Regulated Entity will independently
analyze and evaluate the investment opportunity as to its
appropriateness for such Regulated Entity taking into consideration the
Regulated Entity's Objectives and Strategies.
    9. Applicants state that Triloma serves as the Existing Regulated
Entities' investment adviser and administrator and either it or another
Triloma Advisor will serve in the same capacity to any Future Regulated
Entity, and that EIG serves as the Existing Regulated Entities' sub-
adviser and either it or another EIG Advisor will serve in the same
capacity to any Future Regulated Entity. Applicants represent that
although an EIG Advisor will identify and recommend investments \8\ for
each Regulated Entity, prior to any investment by the Regulated Entity,
the EIG Advisor will present each proposed investment to the Triloma
Advisor which has the authority to approve or reject all investments
proposed for the Regulated Entity by the EIG Advisor.
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    \8\ Applicants represent that the Triloma Advisors will not
source any Potential Co-Investment Transactions under the requested
Order.
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    10. Applicants state that each EIG Advisor has (or will have, in
the case of future advisers) an investment committee through which it
will carry out its obligation under condition 1 to make a determination
as to the appropriateness of a Potential Co-Investment Transaction for
each Regulated Entity. Applicants represent that each EIG Advisor, as a
registered investment adviser, has (or will have, in the case of future
advisers) developed a robust allocation process that is designed to
allocate investment opportunities fairly and equitably among its
clients over time. Applicants state that, in the case of a Potential
Co-Investment Transaction, the applicable EIG Advisor would apply its
allocation policies and procedures in determining the proposed
allocation for the Regulated Entity consistent with the requirements of
condition 2(a).
    11. Applicants state that, once the applicable EIG Advisor
determined a proposed allocation for a Regulated Entity, such EIG
Advisor would notify the applicable Triloma Advisor of the Potential
Co-Investment Transaction and the EIG Advisor's recommended allocation
for such Regulated Entity. Applicants further state that the applicable
Triloma Advisor would then present the Potential Co-Investment
Transaction and the EIG Advisor's proposed allocation to the Triloma
Advisor's investment committee for its approval. Applicants represent
that the Triloma Advisor's investment committee would review the EIG
Advisor's recommendation for the Regulated Entity and would have the
ability to ask questions of the EIG Advisor and request additional
information from the EIG Advisor. Applicants further submit that if the
Triloma Advisor's investment committee approved the investment for the
Regulated Entity, the investment and all relevant allocation
information would then be presented to the Regulated Entity's Board for
its approval in accordance with the conditions to the application.
Applicants state that they believe the investment process between the
EIG Advisors and the Triloma Advisors, prior to seeking approval from

the Regulated Entity's Board (which is in addition to, rather than in
lieu of, the procedures required under the conditions of the
application), is significant and provides for additional procedures and
processes to ensure that the Regulated Entity is being treated fairly
in respect of Potential Co-Investment Transactions.
    12. If the Advisors to a Regulated Entity determine that a
Potential Co-Investment Opportunity is appropriate for the Regulated
Entity (and the applicable Triloma Advisor approves the investment for
such Regulated Entity), and one or more other Regulated Entities and/or
one or more Affiliated Investors may also participate, the Advisors
will present the investment opportunity to the Eligible Trustees \9\ of
the Regulated Entity prior to the actual investment by the Regulated
Entity. As to any Regulated Entity, a Co-Investment Transaction will be
consummated only upon approval by a required majority of the Eligible
Trustees of such Regulated Entity within the meaning of section 57(o)
of the Act (``Required Majority'').\10\
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    \9\ ``Eligible Trustees'' means the trustees or directors of a
Regulated Entity that are eligible to vote under section 57(o) of
the Act.
    \10\ In the case of a Regulated Entity that is a registered
closed-end fund, the trustees or directors that make up the Required
Majority will be determined as if the Regulated Entity were a BDC
subject to section 57(o). As defined in section 57(o), ``required
majority'' means ``both a majority of a business development
company's directors or general partners who have no financial
interest in such transaction, plan, or arrangement and a majority of
such directors or general partners who are not interested persons of
such company.''
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    13. With respect to the pro rata dispositions and follow-on
Investments provided in conditions 7 and 8, a Regulated Entity 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 Entity and
Affiliated Investor 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) each
Regulated Entity's Board has approved that Regulated Entity's
participation in pro rata dispositions and follow-on investments as
being in the best interests of the Regulated Entity. If the Board does
not so approve, any such disposition or follow-on investment will be
submitted to the Regulated Entity's Eligible Trustees. The Board of any
Regulated Entity 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 Trustees.
    14. No Independent Trustee of a Regulated Entity will have a
financial interest in any Co-Investment Transaction.
    15. Under condition 15, if an Advisor or its principals, or any
person controlling, controlled by, or under common control with the
Advisor or its the principals, and any Affiliated Investors
(collectively, the ``Holders'') own in the aggregate more than 25% of
the outstanding voting securities of a Regulated Entity (``Shares''),
then the Holders will vote such Shares as directed by an independent
third party when voting on matters specified in the condition.
Applicants believe that this condition will ensure that the Independent
Trustees will act independently in evaluating the Co-Investment
Program, because the ability of the Advisor or its principals to
influence the Independent Trustees by a suggestion, explicit or
implied, that the Independent Trustees can be removed will be limited
significantly. Applicants represent that the Independent Trustees shall
evaluate and approve any such independent third party, taking into
account its qualifications, reputation for independence, cost to the
shareholders, and other factors that they deem relevant.

Applicants' Legal Analysis

    1. Section 17(d) of the Act and rule 17d-1 under the Act prohibit
participation by a registered investment company and an affiliated
person in any ``joint enterprise or other joint arrangement or profit-
sharing plan,'' as defined in the rule, without prior approval by the
Commission by order upon application. Section 17(d) of the Act and rule
17d-1 under the Act are applicable to Regulated Entities that are
registered closed-end investment companies. Similarly, with regard to
BDCs, section 57(a)(4) of the Act makes it unlawful for any person who
is related to a BDC in a manner described in section 57(b), acting as
principal, knowingly to effect any transaction in which the BDC (or a
company controlled by such BDC) is a joint or a joint and several
participant with that person in contravention of rules as prescribed by
the Commission. Because the Commission has not adopted any rules
expressly under section 57(a)(4), section 57(i) provides that the rules
under section 17(d) applicable to registered closed-end investment
companies (e.g., rule 17d-1) are, in the interim, deemed to apply to
transactions subject to section 57(a). Rule 17d-1, as made applicable
to BDCs by section 57(i), prohibits any person who is related to a BDC
in a manner described in section 57(b), as modified by rule 57b-1, from
acting as principal, from participating in, or effecting any
transaction in connection with, any joint enterprise or other joint
arrangement or profit-sharing plan in which the BDC (or a company
controlled by such BDC) is a participant, unless an application
regarding the joint enterprise, arrangement, or profit-sharing plan has
been filed with the Commission and has been granted by an order entered
prior to the submission of the plan or any modification thereof, to
security holders for approval, or prior to its adoption or modification
if not so submitted.
    2. 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.
    3. Applicants submit that Each Regulated Entity may be deemed to be
an ``affiliated person'' of each other Regulated Entity within the
meaning of section 2(a)(3) of the Act. Applicants state that the
Regulated Entities, by virtue of each having a Triloma Advisor, may be
deemed to be under common control, and thus affiliated persons of each
other under section 2(a)(3)(C) of the Act. Section 17(d) and section
57(b) apply to any investment adviser to a closed-end fund or a BDC,
respectively, including the sub-adviser. Thus, an EIG Advisor and any
Affiliated Investors that it advises could be deemed to be persons
related to Regulated Entities in a manner described by sections 17(d)
and 57(b) and therefore prohibited by sections 17(d) and 57(a)(4) and
rule 17d-1 from participating in the Co-Investment Program. Applicants
further submit that, because the EIG Advisors are ``affiliated
persons'' of other EIG Advisors, Affiliated Investors advised by any of
them could be deemed to be persons related to Regulated Entities (or a
company controlled by a Regulated Entity) in a manner described by
sections 17(d) and 57(b) and also prohibited from participating in the
Co-Investment Program.
    4. Applicants state that they expect that that co-investment in
portfolio companies by a Regulated Entity, one or more other Regulated
Entities and/or one or more Affiliated Investors will increase
favorable investment opportunities for each Regulated Entity.

    5. Applicants submit that the fact that the Required Majority will
approve each Co-Investment Transaction before investment (except for
certain dispositions or follow-on investments, as described in the
conditions), and other protective conditions set forth in the
application, will ensure that each Regulated Entity will be treated
fairly. Applicants state that each Regulated Entity's 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
further state that the terms and conditions proposed herein will ensure
that all such transactions are reasonable and fair to each Regulated
Entity and the Affiliated Investors and do not involve overreaching by
any person concerned, including Triloma or EIG.

Applicants' Conditions

    Applicants agree that the Order will be subject to the following
conditions:
    1. Each time an EIG Advisor considers a Potential Co-Investment
Transaction for an Affiliated Investor or another Regulated Entity that
falls within a Regulated Entity's then-current Objectives and
Strategies, the Advisors to the Regulated Entity will make an
independent determination of the appropriateness of the investment for
the Regulated Entity in light of the Regulated Entity's then-current
circumstances.
    2. a. If the Advisors to a Regulated Entity deem participation in
any Potential Co-Investment Transaction to be appropriate for the
Regulated Entity, the Advisors will then determine an appropriate level
of investment for such Regulated Entity.
    b. If the aggregate amount recommended by the Advisors to a
Regulated Entity to be invested by the Regulated Entity in the
Potential Co-Investment Transaction, together with the amount proposed
to be invested by the other participating Regulated Entities and
Affiliated Investors, collectively, in the same transaction, exceeds
the amount of the investment opportunity, the amount of the investment
opportunity will be allocated among the Regulated Entities and such
Affiliated Investors, pro rata based on each participant's Available
Capital \11\ for investment in the asset class being allocated, up to
the amount proposed to be invested by each. The Advisors to each
participating Regulated Entity will provide the Eligible Trustees of
each participating Regulated Entity with information concerning each
participating party's Available Capital to assist the Eligible Trustees
with their review of the Regulated Entity's investments for compliance
with these allocation procedures.
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    \11\ ``Available Capital'' means (a) for each Regulated Entity,
the amount of capital available for investment determined based on
the amount of cash on hand, existing commitments and reserves, if
any, the targeted leverage level, targeted asset mix and other
investment policies and restrictions set from time to time by the
Board of the applicable Regulated Entity or imposed by applicable
laws, rules, regulations or interpretations and (b) for each
Affiliated Investor, the amount of capital available for investment
determined based on the amount of cash on hand, existing commitments
and reserves, if any, the targeted leverage level, targeted asset
mix and other investment policies and restrictions set by the
Affiliated Investor's directors, general partners or adviser or
imposed by applicable laws, rules, regulations or interpretations.
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    c. After making the determinations required in conditions 1 and
2(a) above, the Advisors to the Regulated Entity will distribute
written information concerning the Potential Co-Investment Transaction,
including the amount proposed to be invested by each Regulated Entity
and any Affiliated Investor, to the Eligible Trustees of each
participating Regulated Entity for their consideration. A Regulated
Entity will co-invest with one or more other Regulated Entities and/or
an Affiliated Investor only if, prior to the Regulated Entities' and
the Affiliated Investors' 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
Entity and its shareholders and do not involve overreaching in respect
of the Regulated Entity or its shareholders on the part of any person
concerned;
    (ii) the Potential Co-Investment Transaction is consistent with:
    (a) The interests of the Regulated Entity's shareholders; and
    (b) the Regulated Entity's then-current Objectives and Strategies;
    (iii) the investment by any other Regulated Entity or an Affiliated
Investor would not disadvantage the Regulated Entity, and participation
by the Regulated Entity would not be on a basis different from or less
advantageous than that of any other Regulated Entity or Affiliated
Investor; provided, that if another Regulated Entity or Affiliated
Investor, but not the Regulated Entity itself, gains the right to
nominate a director for election to a portfolio company's board of
directors or 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 a Required
Majority from reaching the conclusions required by this condition
2(c)(iii), if:
    (a) The Eligible Trustees will have the right to ratify the
selection of such director or board observer, if any; and
    (b) the Advisors to the Regulated Entity agree to, and do, provide
periodic reports to the Regulated Entity'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 other Regulated Entity
or any Affiliated Investor or any affiliated person of any other
Regulated Entity or an Affiliated Investor receives in connection with
the right of one or more Regulated Entities or Affiliated Investors 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
Investors (who may, in turn, share their portion with their affiliated
persons) and any participating Regulated Entity in accordance with the
amount of each party's investment; and
    (iv) the proposed investment by the Regulated Entity will not
benefit the Advisors, any other Regulated Entity or the Affiliated
Investors 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 under sections
17(e) and 57(k) of the Act, as applicable, (C) in the case of fees or
other compensation described in condition 2(c)(iii)(c), or (D)
indirectly, as a result of an interest in the securities issued by one
of the parties to the Co-Investment Transaction.
    3. Each Regulated Entity will have the right to decline to
participate in any Potential Co-Investment Transaction or to invest
less than the amount proposed.
    4. The Advisors will present to the Board of each Regulated Entity,
on a quarterly basis, a record of all investments in Potential Co-
Investment Transactions made by any of the other Regulated Entities or
any of the Affiliated Investors during the preceding quarter that fell
within the Regulated Entity's then-current Objectives and Strategies
that were not made available to the Regulated Entity, and an
explanation of why the investment opportunities were not offered to the
Regulated Entity. All

information presented to the Board pursuant to this condition will be
kept for the life of the Regulated Entity 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,\12\ a Regulated Entity will not invest in reliance on the
Order in any issuer in which another Regulated Entity or an Affiliated
Investor or any affiliated person of another Regulated Entity or an
Affiliated Investor is an existing investor.
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    \12\ This exception applies only to follow-on investments by a
Regulated Entity in issuers in which that Regulated Entity already
holds investments.
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    6. A Regulated Entity 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 Entity and Affiliated
Investor. The grant to one or more Regulated Entities or Affiliated
Investors, but not the Regulated Entity itself, 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 the
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 Regulated Entity or Affiliated Investor elects to sell,
exchange or otherwise dispose of an interest in a security that was
acquired by one or more Regulated Entities and/or Affiliated Investors
in a Co-Investment Transaction, the Advisors will:
    (i) Notify each Regulated Entity 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 Entity in the disposition.
    b. Each Regulated Entity 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 Affiliated Investors
and any other Regulated Entity.
    c. A Regulated Entity may participate in such disposition without
obtaining prior approval of the Required Majority if: (i) The proposed
participation of each Regulated Entity and each Affiliated Investor in
such disposition is proportionate to its outstanding investments in the
issuer immediately preceding the disposition; (ii) the Regulated
Entity's Board has approved as being in the best interests of the
Regulated Entity the ability to participate in such dispositions on a
pro rata basis (as described in greater detail in the application); and
(iii) the Regulated Entity's Board is provided on a quarterly basis
with a list of all dispositions made in accordance with this condition.
In all other cases, the Advisors will provide their written
recommendation as to the Regulated Entity's participation to the
Eligible Trustees, and the Regulated Entity will participate in such
disposition solely to the extent that a Required Majority determines
that it is in the Regulated Entity's best interests.
    d. Each Regulated Entity and each Affiliated Investor will bear its
own expenses in connection with the disposition.
    8. a. If any Regulated Entity or Affiliated Investor desires to
make a ``follow-on investment'' (i.e., an additional investment in the
same entity, including through the exercise of warrants or other rights
to purchase securities of the issuer) in a portfolio company whose
securities were acquired by the Regulated Entity and the Affiliated
Investor in a Co-Investment Transaction, the Advisors will:
    (i) Notify each Regulated Entity 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 Entity.
    b. A Regulated Entity may participate in such follow-on investment
without obtaining prior approval of the Required Majority if: (i) The
proposed participation of each Regulated Entity and each Affiliated
Investor in such investment is proportionate to its outstanding
investments in the issuer immediately preceding the follow-on
investment; and (ii) the Regulated Entity's Board has approved as being
in the best interests of such Regulated Entity 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 Advisors
will provide their written recommendation as to such Regulated Entity's
participation to the Eligible Trustees, and the Regulated Entity will
participate in such follow-on investment solely to the extent that the
Required Majority determines that it is in such Regulated Entity's best
interests.
    c. If, with respect to any follow-on investment:
    (i) The amount of a follow-on investment is not based on the
Regulated Entities' and the Affiliated Investors' outstanding
investments immediately preceding the follow-on investment; and
    (ii) the aggregate amount recommended by the Advisors to be
invested by the Regulated Entity in the follow-on investment, together
with the amount proposed to be invested by the other participating
Regulated Entities and the Affiliated Investors 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 Available Capital 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 be subject to the other conditions set forth in the
application.
    9. The Independent Trustees of each Regulated Entity will be
provided quarterly for review all information concerning Potential Co-
Investment Transactions and Co-Investment Transactions, including
investments made by other Regulated Entities or Affiliated Investors
that a Regulated Entity considered but declined to participate in, so
that the Independent Trustees may determine whether all investments
made during the preceding quarter, including those investments which
the Regulated Entity considered but declined to participate in, comply
with the conditions of the Order. In addition, the Independent Trustees
will consider at least annually the continued appropriateness for such
Regulated Entity of participating in new and existing Co-Investment
Transactions.
    10. Each Regulated Entity will maintain the records required by
section 57(f)(3) of the Act as if each of the Regulated Entities were a
BDC and each of the investments permitted under these conditions were
approved by a Required Majority under section 57(f).
    11. No Independent Trustee of a Regulated Entity will also be a
trustee, director, general partner, managing member or principal, or
otherwise an ``affiliated person'' (as defined in the Act) of any
Affiliated Investor.
    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) shall, to the
extent not payable by the

Advisors under their respective advisory agreements with the Regulated
Entities and the Affiliated Investors, be shared by the Regulated
Entities and the Affiliated Investors 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 break-up or commitment fees but
excluding brokers' fees contemplated by section 17(e) or 57(k) of the
Act, as applicable) \13\ received in connection with a Co-Investment
Transaction will be distributed to the participating Regulated Entities
and Affiliated Investors on a pro rata basis based on the amount they
invested or committed, as the case may be, in such Co-Investment
Transaction. If any transaction fee is to be held by an Advisor pending
consummation of the transaction, the fee will be deposited into an
account maintained by the Advisor 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 Entities and
Affiliated Investors based on the amount they invest in the Co-
Investment Transaction. None of the other Regulated Entities,
Affiliated Investors, the Advisors nor any affiliated person of the
Regulated Entities or the Affiliated Investors 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 Entities and the Affiliated Investors, 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
Advisors, investment advisory fees paid in accordance with the
Regulated Entities' and the Affiliated Investors' investment advisory
agreements).
---------------------------------------------------------------------------

    \13\ Applicants are not requesting and the Commission is not
providing any relief for transaction fees received in connection
with any Co-Investment Transaction.
---------------------------------------------------------------------------

    14. The Advisors to the Regulated Entities and Affiliated Investors
will maintain written policies and procedures reasonably designed to
ensure compliance with the foregoing conditions. These policies and
procedures will require, among other things, that each of the Advisors
to each Regulated Entity will be notified of all Potential Co-
Investment Transactions that fall within a Regulated Entity's then-
current Objectives and Strategies and will be given sufficient
information to make its independent determination and recommendations
under conditions 1, 2(a), 7 and 8.
    15. If the Holders own in the aggregate more than 25 percent of the
shares of a Regulated Entity, then the Holders will vote such shares as
directed by an independent third party when voting on (1) the election
of directors or trustees; (2) the removal of one or more directors or
trustees; or (3) any matters requiring approval by the vote of a
majority of the outstanding voting securities, as defined in section
2(a)(42) of the Act.

    For the Commission, by the Division of Investment Management,
under delegated authority.
Robert W. Errett,
Deputy Secretary.
[FR Doc. 2016-10960 Filed 5-9-16; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 80, Number 85 (Monday, May 4, 2015)]
[Notices]
[Pages 25355-25356]
[FR Doc No: 2015-10263]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2015-0030; Notice 1]

Continental Tire the Americas, LLC, Receipt of Petition for
Decision of Inconsequential Noncompliance

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation (DOT).

ACTION: Receipt of Petition.

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SUMMARY: Continental Tire the Americas, LLC, (CTA), has determined that
certain Continental Tire brand TKC80 motorcycle replacement tires do
not fully comply with paragraph S6.5(c) of Federal Motor Vehicle Safety
Standard (FMVSS) No. 119, New Pneumatic Radial Tires for motor vehicles
with a GVWR of more than 4,536 Kilograms (10,000 pounds) and
Motorcycles. CTA has filed an appropriate report dated February 18,
2015, pursuant to 49 CFR part 573, Defect and Noncompliance
Responsibility and Reports.

DATES: The closing date for comments on the petition is June 3, 2015.

ADDRESSES: Interested persons are invited to submit written data,
views, and arguments on this petition. Comments must refer to the
docket and notice number cited at the beginning of this notice and
submitted by any of the following methods:
     Mail: Send comments by mail addressed to: U.S. Department
of Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590.
     Hand Deliver: Deliver comments by hand to: U.S. Department
of Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590. The
Docket Section is open on weekdays from 10 a.m. to 5 p.m. except
Federal Holidays.
     Electronically: Submit comments electronically by: logging
onto the Federal Docket Management System (FDMS) Web site at http://www.regulations.gov/. Follow the online instructions for submitting
comments. Comments may also be faxed to<PHONE_NUMBER>.
    Comments must be written in the English language, and be no greater
than 15 pages in length, although there is no limit to the length of
necessary attachments to the comments. If comments are submitted in
hard copy form, please ensure that two copies are provided. If you wish
to receive confirmation that your comments were received, please
enclose a stamped, self-addressed postcard with the comments. Note that
all comments received will be posted without change to http://www.regulations.gov, including any personal information provided.
    Documents submitted to a docket may be viewed by anyone at the
address and times given above. The documents may also be viewed on the
Internet at http://www.regulations.gov by following the online
instructions for accessing the dockets. DOT's complete Privacy Act
Statement is available for review in the Federal Register published on
April 11, 2000, (65 FR 19477-78).
    The petition, supporting materials, and all comments received
before the close of business on the closing date indicated below will
be filed and will be considered. All comments and supporting materials
received after the closing date will also be filed and will be
considered to the extent possible. When the petition is granted or
denied, notice of the decision will be published in the Federal
Register pursuant to the authority indicated below.

SUPPLEMENTARY INFORMATION:

I. CTA's Petition

    Pursuant to 49 U.S.C. 30118(d) and 30120(h) (see implementing rule
at 49 CFR part 556), CTA submitted a petition for an exemption from the
notification and remedy requirements of 49 U.S.C. Chapter 301 on the
basis that this noncompliance is inconsequential to motor vehicle
safety.
    This notice of receipt of CTA's petition is published under 49
U.S.C. 30118 and 30120 and does not represent any agency decision or
other exercise of judgment concerning the merits of the petition.

II. Tires Involved

    Affected are approximately 1,062 Continental TKC80 size 120/70-19
M/C 60Q diagonal (bias) motorcycle replacement tires manufactured
between April 8, 2012 and January 31, 2015.

III. Noncompliance

    CTA explains that the noncompliance is that the tire size
designation marking on the sidewalls of the subject tires does not
contain the correct construction code designator symbol from The Tire
and Rim Association yearbook. Therefore, the tires do not fully comply
with paragraph S6.5(c) of FMVSS No. 119 because the tire size
designation is not as listed in the documents and publications
designated in S5.1. Specifically, the tires were marked with the
construction code designator ``B'' indicating bias-belted construction
and should have been marked with the designator ``-'' indicating
diagonal (bias) construction.

IV. Rule Text

    Paragraph S6.5 of FMVSS No. 119 requires in pertinent part:
    S6.5 Tire Markings. Except as specified in paragraphs, each tire
shall be marked on each sidewall with the information specified in
paragraphs (a) through (j) of this section. . .
    (c) The tire size designation as listed in the documents and
publications designated in S5.1.

V. Summary of CTA's Analyses

    CTA stated its belief that the subject noncompliance is
inconsequential to motor vehicle safety for the following reasons:

    (A) CTA notes that the only improper marking on the sidewall of
the subject tires is the use of the letter character ``B'' in the

tire size designation instead of a hyphen character ``-,'' and that
from its experience it believes that most motorcycle tire consumers
do not understand the differences in tire construction and therefore
do not base tire purchases on the tire construction type.
    (B) CTA stated that the subject tires were built as designed and
that the performance requirements and testing requirements specified
in FMVSS No. 119 are exactly the same for both bias-belted and
diagonal (bias) tires.
    (C) CTA believes that the subject noncompliance has no impact on
the safety of vehicles on which the subject tires are mounted and
that the subject tires meet or exceed all the performance
requirement of FMVSS No. 119.
    (D) CTA also stated that it is not aware of any crashes,
injuries, customer complaints, or field reports associated with the
subject noncompliance.

    CTA additionally informed NHTSA that the molds at the manufacturing
plant have been corrected so that no additional tires will be
manufactured or sold with the noncompliance.
    In summation, CTA believes that the described noncompliance of the
subject tires is inconsequential to motor vehicle safety, and that its
petition, to exempt CTA from providing recall notification of
noncompliance as required by 49 U.S.C. 30118 and remedying the recall
noncompliance as required by 49 U.S.C. 30120 should be granted.
    NHTSA notes that the statutory provisions (49 U.S.C. 30118(d) and
30120(h)) that permit manufacturers to file petitions for a
determination of inconsequentiality allow NHTSA to exempt manufacturers
only from the duties found in sections 30118 and 30120, respectively,
to notify owners, purchasers, and dealers of a defect or noncompliance
and to remedy the defect or noncompliance. Therefore, any decision on
this petition only applies to the subject tires that CTA no longer
controlled at the time it determined that the noncompliance existed.
However, any decision on this petition does not relieve equipment
distributors and dealers of the prohibitions on the sale, offer for
sale, or introduction or delivery for introduction into interstate
commerce of the noncompliant tires under their control after CTA
notified them that the subject noncompliance existed.

    Authority:  49 U.S.C. 30118, 30120: delegations of authority at
49 CFR 1.95 and 501.8.

Jeffrey Giuseppe,
Director, Office of Vehicle Safety Compliance.
[FR Doc. 2015-10263 Filed 5-1-15; 8:45 am]
 BILLING CODE 4910-59-P


[Federal Register Volume 87, Number 126 (Friday, July 1, 2022)]
[Rules and Regulations]
[Pages 39334-39335]
[FR Doc No: 2022-14117]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2022-0623; Airspace Docket No. 22-AGL-13]
RIN 2120-AA66

Amendment of Area Navigation (RNAV) Route Q-440; MI

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: This action amends the legal description of area navigation
(RNAV) route Q-440 by changing one route point reflected as a fix to a
waypoint (WP) and removing one route point that is not required for
defining the route structure. This action does not change the Q-440
structure, charted alignment, or the operating requirements of the
route.

DATES: Effective date 0901 UTC, September 8, 2022. The Director of the
Federal Register approves this incorporation by reference action under
1 CFR part 51, subject to the annual revision of FAA Order JO 7400.11
and publication of conforming amendments.

ADDRESSES: FAA Order JO 7400.11F, Airspace Designations and Reporting
Points, and subsequent amendments can be viewed online at https://www.faa.gov/air_traffic/publications/. For further information, you can
contact the Rules and Regulations Group, Federal Aviation
Administration, 800 Independence Avenue SW, Washington, DC 20591;
telephone:<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Colby Abbott, Rules and Regulations
Group, Office of Policy, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
the airspace necessary to ensure the safety of aircraft and the
efficient use of airspace. This regulation is within the scope of that
authority as it modifies the route description, but retains the route
structure as necessary to preserve the safe and efficient flow of air
traffic within the National Airspace System (NAS).

History

    RNAV route Q-440 extends through the Great Lakes region into New
England between the HUFFR, MN, WP and the RAAKK, NY, WP. After
reviewing Q-440 in preparation of upcoming planned navigational aid
decommissioning actions, the FAA determined one route point listed in
the route description could be removed without affecting the route's
structure or charted alignment. The SLLAP, MI, WP in the Q-440
description does not denote a route turn point, have established
holding requirements, and does not result in PBN leg length maximum
allowable distances being exceeded; therefore, it is not required in
the description.
    Further, the FAA is changing the DEANI, MI, fix to become a WP in
the aeronautical database. As such, the DEANI, MI, fix will be amended
in the Q-440 description to reflect the route point as a WP.
    Once this action is completed, the SLLAP, MI, WP will continue to
be depicted on the IFR En Route High Altitude charts and support air
traffic control requirements.
    United States Area Navigation Routes (Q-routes) are published in
paragraph 2006 of FAA Order JO 7400.11F, dated August 10, 2021, and
effective September 15, 2021, which is incorporated by reference in 14
CFR 71.1. The Q-440 route listed in this document will be published
subsequently in FAA Order JO 7400.11.

Availability and Summary of Documents for Incorporation by Reference

    This document amends FAA Order JO 7400.11F, Airspace Designations
and Reporting Points, dated August 10, 2021, and effective September
15, 2021. FAA Order JO 7400.11F is publicly available as listed in the
ADDRESSES section of this document. FAA Order JO 7400.11F lists Class
A, B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Rule

    This action amends 14 CFR part 71 by amending Q-440 in Michigan. Q-
440 extends between the HUFFR, MN, WP and the RAAKK, NY, WP. The DEANI,
MI, fix will be changed to reflect the route point as the DEANI, MI, WP
in the route description. The SLLAP, MI, WP route point is removed from
the description of Q-440 between the DEANI, MI, WP and the BERYS, MI,
WP. The SLLAP WP is on a straight segment of the route and not required
to retain the route's structure. The charted depiction of Q-440 is
unchanged and the full route description is listed in The Amendment
section, below.
    This is an administrative change and does not affect the Q-440
route structure, charted alignment, or the operating requirements of
the route. Therefore, notice and public procedure under 5 U.S.C. 553(b)
is unnecessary.
    FAA Order JO 7400.11, Airspace Designations and Reporting Points,
is published yearly and effective on September 15.

Regulatory Notices and Analyses

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore: (1) is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under
Department of Transportation (DOT) Regulatory Policies and Procedures
(44 FR 11034;

February 26, 1979); and (3) does not warrant preparation of a
regulatory evaluation as the anticipated impact is so minimal. Since
this is a routine matter that only affects air traffic procedures and
air navigation, it is certified that this rule, when promulgated, does
not have a significant economic impact on a substantial number of small
entities under the criteria of the Regulatory Flexibility Act.

Environmental Review

    The FAA has determined that this action of amending the legal
description of RNAV route Q-440, by changing one route point from a fix
to a WP and removing an unnecessary route point from the route
description, qualifies for categorical exclusion under the National
Environmental Policy Act (42 U.S.C. 4321 et seq.) and its implementing
regulations at 40 CFR part 1500. This is also in accordance with FAA
Order 1050.1F, Environmental Impacts: Policies and Procedures,
paragraph 5-6.5a, which categorically excludes from further
environmental impact review rulemaking actions that designate or modify
classes of airspace areas, airways, routes, and reporting points (see
14 CFR part 71, Designation of Class A, B, C, D, and E Airspace Areas;
Air Traffic Service Routes; and Reporting Points), and paragraph 5-
6.5k, which categorically excludes from further environmental impact
review the publication of existing air traffic control procedures that
do not essentially change existing tracks, create new tracks, change
altitude, or change concentration of aircraft on these tracks. As such,
this action is not expected to result in any potentially significant
environmental impacts. In accordance with FAA Order 1050.1F, paragraph
5-2 regarding Extraordinary Circumstances, the FAA has reviewed this
action for factors and circumstances in which a normally categorically
excluded action may have a significant environmental impact requiring
further analysis. The FAA has determined that no extraordinary
circumstances exist that warrant preparation of an environmental
assessment or environmental impact study.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Amendment

    In consideration of the foregoing, the Federal Aviation
Administration amends 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for 14 CFR part 71 continues to read as
follows:

    Authority: 49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order JO
7400.11F, Airspace Designations and Reporting Points, dated August 10,
2021, and effective September 15, 2021, is amended as follows:

Paragraph 2006 United States Area Navigation Routes.

* * * * *

Q-440 HUFFR, MN to RAAKK, NY [Amended]

HUFFR, MN                     WP                  (Lat. 45[deg]08'48.63'' N, long. 093[deg]29'29.66'' W)
IDIOM, WI                     WP                  (Lat. 44[deg]30'18.00'' N, long. 088[deg]17'57.00'' W)
DEANI, MI                     WP                  (Lat. 43[deg]43'07.35'' N, long. 085[deg]46'29.20'' W)
BERYS, MI                     WP                  (Lat. 42[deg]54'33.97'' N, long. 083[deg]17'59.75'' W)
TWIGS, MI                     WP                  (Lat. 42[deg]48'34.10'' N, long. 082[deg]33'10.30'' W)
JAAJA, Canada                 WP                  (Lat. 42[deg]40'00.00'' N, long. 081[deg]16'00.00'' W)
ICHOL, Canada                 WP                  (Lat. 42[deg]38'31.46'' N, long. 080[deg]30'13.99'' W)
FARGN, Canada                 WP                  (Lat. 42[deg]36'42.19'' N, long. 079[deg]47'18.42'' W)
RAAKK, NY                     WP                  (Lat. 42[deg]23'59.00'' N, long. 078[deg]54'39.00'' W)

    Excluding the airspace within Canada.
* * * * *

    Issued in Washington, DC, on June 27, 2022.
Scott M. Rosenbloom,
Manager, Airspace Rules and Regulations.
[FR Doc. 2022-14117 Filed 6-30-22; 8:45 am]
BILLING CODE 4910-13-P


                  UNITED STATES ENVIRONMENTAL PROTECTION AGENCY                 NATIONAL VEHICLE AND FUEL EMISSIONS LABORATORY                              2000 TRAVERWOOD DRIVE                            ANN ARBOR, MI  48105-2498

									     OFFICE OF 									AIR AND RADIATION 3/9/16

MEMORANDUM

SUBJECT: Dana visit on Phase 2 Axle Related Topics

FROM: Houshun Zhang

TO:  Greenhouse Gas Emissions Standards and Fuel Efficiency Standards for Medium- and Heavy-Duty Engines and Vehicles - Phase 2 - Docket EPA-HQ-OAR-2014-0827

This memo documents an on-site meeting at EPA on March 9, 2016 between Dana and EPA on axle related to the Phase 2 greenhouse gas and fuel efficiency standards for heavy-duty vehicles.  Five people from Dana are Steven Mastrionni, Steven Wesolowski, Krishna Kumar, Hary Trost, and Ben Passino.

During the meeting, Dana first provided what they understood about Phase 2, and then asked many questions regarding how the axle is modeled in GEM, such as axle efficiency and power loss, 6x2 vs 6x4 ,etc.  The meeting also talked about axle test procedure.  Both agency and Dana agreed that a follow-up meeting was needed about their finding regarding the NODA released version of GEM in the near future.


[Federal Register: October 28, 2009 (Volume 74, Number 207)]
[Proposed Rules]
[Page 55505-55506]
[DOCID:fr28oc09-27]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 9 and 63

[EPA-HQ-OAR-2003-0146; FRL-8972-3]
RIN 2060-AO55

National Emission Standards for Hazardous Air Pollutants From
Petroleum Refineries

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed partial withdrawal of final rule.

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

SUMMARY: EPA is proposing to withdraw the residual risk and technology
review portions of the final rule amending the National Emission
Standards for Hazardous Air Pollutants From Petroleum Refineries, which
was signed by then Administrator Stephen Johnson, on January 16, 2009.

DATES: Written comments must be received on or before November 27,
2009, unless a public hearing is requested by November 9, 2009. If a
hearing is requested on the proposed partial withdrawal, written
comments must be received by December 14, 2009.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OAR-2003-0146, by one of the following methods:
     E-mail: Comments may be sent by electronic mail (e-mail)
to<EMAIL_ADDRESS>Attention Docket ID No. EPA-HQ-OAR-2003-
0146.
     Fax: Fax your comments to:<PHONE_NUMBER>, Attention
Docket ID No. EPA-HQ-OAR-2003-0146.
     Mail: Send your comments to: Air and Radiation Docket and
Information Center, Environmental Protection Agency, Mailcode: 2822T,
1200 Pennsylvania Ave., NW., Washington, DC 20460, Attention Docket ID
No. EPA-HQ-OAR-2003-0146. Please include a total of two copies. We
request that a separate copy also be sent to the contact person
identified below (see FOR FURTHER INFORMATION CONTACT).
     Hand Delivery: In person or by courier, deliver comments
to: EPA Docket Center, EPA West, Room 3334, 1301 Constitution Avenue,
NW., Washington, DC 20004. Such deliveries are only accepted during the
Docket's normal hours of operation, and special arrangements should be
made for deliveries of boxed information. Please include a total of two
copies.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-OAR-
2003-0146. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
confidential business information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through http://
www.regulations.gov or e-mail. The http://www.regulations.gov Web site
is an ``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an e-mail comment directly to EPA without
going through http://www.regulations.gov, your e-mail address will be
automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses.
    Docket: All documents in the docket are listed in the http://
www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in http://www.regulations.gov or in hard copy at the EPA Docket Center,
Public Reading Room, EPA West Building, Room 3334, 1301 Constitution
Ave., NW., Washington, DC. The Public Reading Room is open from 8:30
a.m. to 4:30 p.m. Eastern Standard Time (EST), Monday through Friday,
excluding legal holidays. The telephone number for the Public Reading
Room is<PHONE_NUMBER>, and the telephone number for the Air and
Radiation Docket is<PHONE_NUMBER>.
    We request that you also send a separate copy of each comment to
the contact persons listed below (see FOR FURTHER INFORMATION CONTACT).
    CBI: Do not submit information containing CBI to EPA through http:/
/www.regulations.gov or e-mail. Send or deliver information identified
as CBI only to the following address: Roberto Morales, OAQPS Document
Control Officer (C404-02), Office of Air Quality Planning and
Standards, Environmental Protection Agency, Research Triangle Park, NC
27711, Attention Docket ID No. EPA-HQ-OAR-2003-0146. Clearly mark the
part of all of the information that you claim to be CBI. For CBI
information in a disk or CD-ROM that you mail to EPA, mark the outside
of the disk or CD-ROM as CBI and then identify electronically within
the disk or CD-ROM the specific information that is claimed as CBI. In
addition to one complete version of the comment that includes
information claimed as CBI, a copy of the comment that does not contain
the information claimed as CBI must be submitted for inclusion in the
public docket. Information so marked will not be disclosed except in
accordance with procedures set forth in 40 CFR part 2.
    Public Hearing: If anyone contacts EPA requesting to speak at a
public hearing by November 9, 2009, a public hearing will be held on
November 12, 2009. Persons interested in presenting oral testimony or
inquiring as to whether a public hearing is to be held should contact
Mr. Bob Lucas, listed in the FOR FURTHER INFORMATION CONTACT section,
at least 2 days in advance of the hearing. If a public hearing is held,
it will be held at 10 a.m. at the EPA's Environmental Research Center
Auditorium, Research Triangle Park, NC, or an alternate site nearby.

FOR FURTHER INFORMATION CONTACT: Mr. Robert B. Lucas, Office of Air
Quality Planning and Standards, Sector Policies and Programs Division,
Coatings and Chemicals Group (E143-01), Environmental Protection
Agency, Research Triangle Park, NC 27711, telephone number: (919) 541-
0884; fax number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Section 112 of the Clean Air Act (CAA)
establishes a two-stage regulatory process to address emissions of
hazardous air pollutants (HAP) from stationary sources. In the first
stage, after EPA has identified categories of sources emitting one or
more of the HAP listed in section 112(b) of the CAA, section 112(d)
calls for us to promulgate national emission standards for

hazardous air pollutants (NESHAP) for those sources. The EPA is then
required to review these technology-based standards and to revise them
``as necessary (taking into account developments in practices,
processes, and control technologies)'' no less frequently than every 8
years, under CAA section 112(d)(6). The second stage in standard-
setting focuses on reducing any remaining ``residual'' risk according
to CAA section 112(f).
    On January 16, 2009, then Administrator Stephen Johnson signed a
final rule amending the National Emission Standards for Hazardous Air
Pollutants From Petroleum Refineries and the signed rule was made
publicly available on EPA's Web site. The signed rule included several
different actions. First, it promulgated maximum achievable control
technology (MACT) standards under sections 112(d)(2) and (3) for heat
exchange systems, which EPA had not addressed in the original Refinery
MACT 1 rule. Second, pursuant to CAA section 112(f)(2), the rule
addressed residual risk for all Refinery MACT 1 sources, including heat
exchange systems, and it addressed the technology review pursuant to
CAA section 112(d)(6) for all sources addressed in the original
Refinery MACT 1 rule. Additionally, we updated the table in the
Refinery MACT 1 standards (Table 6) that cross-references the General
Provisions in 40 CFR part 63, subpart A, and made a few additional
clarifications to dates and cross-references in the Refinery MACT 1
standards.
    The signed rule was submitted to the Office of the Federal Register
for publication. Rahm Emanuel, Assistant to the President and Chief of
Staff, issued a memorandum on January 20, 2009, directing Agencies to
withdraw from the Office of the Federal Register ``all proposed or
final regulations that have not been published in the Federal Register
so that they can be reviewed and approved by a department or agency
head.'' Although there was an exception for ``regulations subject to
statutory or judicial deadlines,'' the Agency chose not to apply the
exception in this case. One portion of the final rule, the CAA section
112(d)(6) review, was performed pursuant to the terms of a Consent
Decree, which, as modified, required that by January 16, 2009, EPA
``shall sign and promptly forward to the Federal Register for
publication either final revisions to the standards for petroleum
refineries in 40 CFR Part 63, Subpart CC pursuant to 42 U.S.C.
7412(d)(6) or a final determination that no revisions are necessary.''
Former Administrator Stephen Johnson signed the rule on January 16,
2009, and promptly forwarded it to the Federal Register office, thus,
fulfilling this obligation.\1\
---------------------------------------------------------------------------

    \1\ We note that on January 30, 2009, the litigants notified EPA
by letter that they believed the Agency had discharged its
obligation under the consent decree and that ``further review of the
rule pursuant to the Emanuel memo will not violate the consent
decree.''
---------------------------------------------------------------------------

    Upon further review, EPA has determined that the residual risk and
technology reviews may not accurately characterize the risk posed by
this source category. We recently responded to a Request for Correction
under EPA's Information Quality Guidelines from the City of Houston.
(Letter to U.S. EPA Information Quality Guidelines staff from the
Honorable Bill White, Mayor of Houston, July 9, 2008.) In that
response, we recognized that we are currently taking action (and plan
to take additional action) to gather better emissions information from
the refining industry. Additionally, we note that during the comment
period on the proposed rule, similar issues were raised concerning the
representativeness of the emissions data, and whether they provide an
accurate basis for characterizing the risks posed. Accordingly, after
additional consideration of these issues, we believe it is necessary to
withdraw the rule that was signed on January 16, 2009, so that we may
develop a more robust analysis based on the improved information we are
developing.
    For these reasons, EPA is proposing to withdraw the signed final
rule that included the residual risk and technology review for Refinery
MACT 1 sources to provide the Agency with time to collect additional
data and perform these analyses. Once EPA has undertaken these
activities, we will provide the public with an opportunity to comment
on a new proposed rule that would be issued.
    Simultaneous with the issuance of this proposal, we are publishing
in the Federal Register a final rule identical in substance to that
signed on January 16, 2009, for: (1) The technology-based MACT
standards for heat exchange systems under section 112(d)(2) and (3) of
the CAA; (2) revisions to Table 6 of the existing Refinery MACT 1 rule
(subpart CC), which describes the application of the NESHAP General
Provisions in 40 CFR part 63, subpart A to subpart CC; and (3) the
other conforming changes and corrections that were included as part of
the January 16, 2009 rule. The portions of the January 16, 2009 rule
that are being published as a final rule are included in a new Federal
Register notice signed by Administrator Jackson and, regarding those
issues, are identical in substance to the final rule that was signed by
former Administrator Stephen Johnson.

List of Subjects in 40 CFR Part 63

    Environmental protection, Air pollution control, Hazardous
substances, Reporting and recordkeeping requirements.

    Dated: October 15, 2009.
Lisa P. Jackson,
Administrator.
[FR Doc. E9-25453 Filed 10-27-09; 8:45 am]

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[Federal Register Volume 75, Number 233 (Monday, December 6, 2010)]
[Notices]
[Pages 75678-75679]
[FR Doc No: 2010-30512]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2010-E-0032 and FDA-2010-E-0036]

Determination of Regulatory Review Period for Purposes of Patent
Extension; STELARA

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for STELARA 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 Patents
and Trademarks, Department of Commerce, for the extension of a patent
which claims that human biological product.

ADDRESSES: Submit electronic comments to http://www.regulations.gov.
Submit written petitions along with three copies and written comments
to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6222, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: 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 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 biological products, the
testing phase begins when the exemption to permit the clinical
investigations of the biological becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human biological product and
continues until FDA grants permission to market the biological product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of Patents and
Trademarks 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 biological product will include all of the testing
phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).
    FDA recently approved for marketing the human biologic product
STELARA (ustekinumab). STELARA is indicated for treatment of adult
patients with severe plaque psoriasis who are candidates for
phototherapy or systemic therapy. Subsequent to this approval, the
Patent and Trademark Office received a patent term restoration
application for STELARA (U.S. Patent No. 6,902,734 and 7,166,285) from
Centocor Ortho Biotech Inc., and the Patent and Trademark Office
requested FDA's assistance in determining the patents' eligibility for
patent term restoration. In a letter dated March 24, 2010, FDA advised
the Patent and Trademark Office that this human biological product had
undergone a regulatory review period and that the approval of STELARA
represented the first permitted commercial marketing or use of the
product. Thereafter, the Patent and Trademark Office requested that FDA
determine the product's regulatory review period.
    FDA has determined that the applicable regulatory review period for
STELARA is 3,165 days. Of this time, 2,498 days occurred during the
testing phase of the regulatory review period, while 667 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 (21 U.S.C. 355(i)) became effective: January 27,
2001. The applicant claims December 28, 2000 as the date the
investigational new drug application (IND) became effective. However,
FDA records indicate that the IND effective date was January 27, 2001,
which was 30 days after FDA receipt of the IND.
    2. The date the application was initially submitted with respect to
the human biological product under section 351 of the Public Health
Service Act (42 U.S.C. 262): November 29, 2007. FDA has verified the
applicant's claim that the biologics license application (BLA) for
STELARA (BLA 125261/0) was initially submitted on November 29, 2007.
    3. The date the application was approved: September 25, 2009. FDA
has verified the applicant's claim that BLA 125261/0 was approved on
September 25, 2009.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the U.S.
Patent and Trademark Office applies several statutory limitations in
its calculations of the actual period for patent extension. In its
applications for patent extension, this applicant seeks 425 or 510 days
of patent term extension.
    Anyone with knowledge that any of the dates as published are
incorrect may submit to the Division of Dockets Management (see
ADDRESSES) either electronic or written comments and ask for a
redetermination by February 4, 2011. 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 June 6, 2011. To meet its burden, the petition must contain
sufficient facts to merit an FDA investigation. (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.
    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) electronic or written comments and written petitions.
It is only necessary to send one set of comments. It is no longer
necessary to send three copies of mailed comments. However, if you
submit a written petition, you must submit three copies of the
petition. Identify comments with the docket number found in brackets in
the heading of this document. Comments and petitions that have not been
made publicly available on regulations.gov may be viewed in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.

    Dated: October 22, 2010.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 2010-30512 Filed 12-3-10; 8:45 am]
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[Federal Register Volume 77, Number 103 (Tuesday, May 29, 2012)]
[Notices]
[Pages 31622-31624]
[FR Doc No: 2012-12878]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0274]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Adverse Event
Reporting and Recordkeeping for Dietary Supplements as Required by the
Dietary Supplement and Nonprescription Drug Consumer Protection Act

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by June
28, 2012.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0428.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400T,
Rockville, MD 20850,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Adverse Event Reporting and Recordkeeping for Dietary Supplements as
Required by the Dietary Supplement and Nonprescription Drug Consumer
Protection Act--21 U.S.C. 379aa-1(b)(1) (OMB Control Number 0910-
0635)--Extension

    The Dietary Supplement and Nonprescription Drug Consumer Protection
Act (DSNDCPA) (Pub. L. 109-462, 120 Stat. 3469) amends the Federal
Food, Drug, and Cosmetic Act (the FD&C Act) with respect to serious
adverse event reporting and recordkeeping for dietary supplements and
nonprescription drugs marketed without an approved application. Section
761(b)(1) of the FD&C Act (21 U.S.C. 379aa-1(b)(1)) requires the
manufacturer, packer, or distributor whose name (under section
403(e)(1) of the FD&C Act (21 U.S.C. 343(e)(1))) appears on the label
of a dietary supplement marketed in the United States to submit to FDA
all serious adverse event reports associated with the use of a dietary
supplement, accompanied by a copy of the product label. The
manufacturer, packer, or distributor of a dietary supplement is
required by the DSNDCPA to use the MedWatch form (FDA 3500A) when
submitting a serious adverse event report to FDA. In addition, under
section 761(c)(2) of the FD&C Act, the submitter of the serious adverse
event report (referred to in the statute as the ``responsible person'')
is required to submit to FDA a followup report of any related new
medical information the responsible person receives within 1 year of
the initial report.
    Section 761(e)(1) of the FD&C Act (21 U.S.C. 379aa-1(e)(1))
requires that responsible persons maintain records related to the
dietary supplement adverse event reports they receive, whether or not
the adverse event is serious. Under the statute, the records must be
retained for a period of 6 years.
    As required by section 3(d)(3) of the DSNDCPA, FDA issued guidance
to describe the minimum data elements for serious adverse event reports
for dietary supplements. In the Federal Register of July 14, 2009 (74
FR 34024), FDA announced the availability of guidance entitled
``Guidance for Industry: Questions and Answers Regarding Adverse Event
Reporting and Recordkeeping for Dietary Supplements as Required by the
Dietary Supplement and Nonprescription Drug Consumer Protection Act.''
The guidance discusses how, when, and where to submit serious adverse
event reports for dietary supplements and followup reports. The
guidance also provides FDA's recommendation on records maintenance and
access for serious and non-serious adverse event reports and related
documents.
    The guidance recommends that the responsible person document the
attempts to obtain the minimum data elements for a serious adverse
event report. Along with these records, the guidance recommends that
the responsible person keep the following other records: (1)
Communications between the responsible person and the initial reporter
of the adverse event and

between the responsible person and any other person(s) who provided
information about the adverse event, (2) the responsible person's
serious adverse event report to FDA with attachments, (3) any new
information about the adverse event received by the responsible person,
and (4) any reports to FDA of new information related to the serious
adverse event report.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
        21 U.S.C. Section            Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
21 U.S.C. 379aa-1(b)(1)--Serious             480              17           8,160               2          16,320
 adverse event reports for
 dietary supplements............
21 U.S.C. 379aa-1(c)(2)--                    120              17           2,040               1           2,040
 Followup reports of new medical
 information....................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............          18,360
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    This estimate is based on FDA's experience with similar adverse
event reporting programs and the number of serious adverse event
reports and followup reports received in the past 2 years. All dietary
supplement manufacturers, packers, or distributors are subject to
serious adverse event mandatory reporting. In 2007, we estimated in the
final rule entitled ``Current Good Manufacturing Practice in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements'' (72 FR 34752, June 25, 2007) that there were 1,460 such
firms. FDA estimates that, in 2012, there are approximately 1,600 such
firms, based on the estimate of 1,460 provided in the rule, with a 2 to
3 percent annual rate of growth applied.
    FDA received 830 initial serious adverse event reports in FY 2010.
The number of reports more than doubled to 1,777 in FY 2011. We expect
this trend to continue and, in fact, increase due to continued industry
compliance with mandatory reporting rules. Based on this, FDA expects
to receive over the next 3 years an increasing number of reports per
year: We estimate that we will receive 3,500 in 2012; 7,000 in 2013;
and 14,000 in 2014; for an annual average of 8,166.66 per year, rounded
to 8,160. Based on the Agency's records, the average number of initial
reports per year on a per firm basis during 2010 and 2011 was 17. Thus,
FDA estimates that, on average over the next 3 years, 480 firms will
file 17 initial dietary supplement serious adverse event reports, for a
total of 8,160 total annual responses.
    FDA estimates that it will take respondents an average of 2 hours
per report to collect information about a serious adverse event
associated with a dietary supplement and report the information to FDA
on Form FDA 3500A. Thus, the estimated total annual hour burden of
initial dietary supplement serious adverse event reports is 16,320
hours (8,160 responses x 2 hours) as shown in row 1 of table 1 in this
document.
    If a respondent that has submitted a serious adverse event report
receives new information related to the serious adverse event within 1
year of submitting the initial report, the respondent must provide the
new information to FDA in a followup report. FDA estimates that 25
percent of serious adverse event reports related to dietary supplements
will have a followup report submitted, resulting in approximately 2,040
followup reports submitted annually (8,160 x 0.25 = 2,040). Assuming
that 25 percent of submitters of initial reports will submit followup
reports (480 x 0.25 = 120) and the average number of followup reports
per year per firm to be 17, FDA estimates that, on average over the
next 3 years, 120 firms will file 17 followup reports, for a total of
2,040 total annual responses. We estimate that each followup report
will require an hour to assemble and submit, including the time needed
to copy and attach the initial serious adverse event report as
recommended in the guidance. The estimated total annual hour burden for
followup reports of new information is 2,040 hours (2,040 responses x 1
hour) as shown in row 2 of table 1.
    The total reporting hour burden is 18,360 hours, which equals the
burden for the mandatory reports (16,320) plus the burden for the
followup new information (2,040).

                               Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                    Average burden
        21 U.S.C. Section            Number of      records per    Total annual         per         Total hours
                                   recordkeepers   recordkeeper       records      recordkeeping
----------------------------------------------------------------------------------------------------------------
(21 U.S.C. 379aa-1(e)(1))--                1,600              74         118,400         \2\ 0.5          59,200
 Dietary supplement adverse
 event records..................
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ 30 minutes.

    All 1,600 dietary supplement manufacturers, packers, or
distributors, are subject to serious adverse event mandatory
recordkeeping, thus FDA estimates that there are a total of 1,600
recordkeepers. FDA further estimates that each recordkeeper will keep
approximately 74 records per year, for a total of 118,400 records. The
Agency estimates that assembling and filing these records, including
any necessary photocopying, will take approximately 30 minutes, or 0.5
hours, per record. Therefore, 118,400 records x 0.50 hours = 59,200
total hours. FDA bases its estimates on its experience with similar
adverse event reporting programs.
    Once the documents pertaining to an adverse event report have been
assembled and filed under the Safety Reporting Portal, FDA expects the

records retention burden to be minimal, as the Agency believes most
establishments would normally keep this kind of record for at least
several years after receiving the report, as a matter of usual and
customary business practice.

    Dated: May 22, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-12878 Filed 5-25-12; 8:45 am]
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