[Federal Register Volume 85, Number 42 (Tuesday, March 3, 2020)]
[Notices]
[Pages 12567-12568]
[FR Doc No: 2020-04320]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0369]

Product-Specific Guidances; Draft and Revised Draft Guidances for
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of additional draft and revised draft product-specific
guidances. The guidances provide product-specific recommendations on,
among other things, the design of bioequivalence (BE) studies to
support abbreviated new drug applications (ANDAs). In the Federal
Register of June 11, 2010, FDA announced the availability of a guidance
for industry entitled ``Bioequivalence Recommendations for Specific
Products'' that explained the process that would be used to make
product-specific guidances available to the public on FDA's website.
The guidances identified in this notice were developed using the
process described in that guidance.

DATES: Submit either electronic or written comments on the draft
guidance by May 4, 2020 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2007-D-0369 for ``Product-Specific Guidances; Draft and Revised
Draft Guidances for Industry.'' Received comments will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available

for public viewing and posted on https://www.regulations.gov. Submit
both copies to the Dockets Management Staff. If you do not wish your
name and contact information to be made publicly available, you can
provide this information on the cover sheet and not in the body of your
comments and you must identify this information as ``confidential.''
Any information marked as ``confidential'' will not be disclosed except
in accordance with 21 CFR 10.20 and other applicable disclosure law.
For more information about FDA's posting of comments to public dockets,
see 80 FR 56469, September 18, 2015, or access the information at:
https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidances to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance documents.

FOR FURTHER INFORMATION CONTACT: Mara Miller, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 4709C, Silver Spring, MD 20993-0002, 301-
796-0683.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of June 11, 2010 (75 FR 33311), FDA
announced the availability of a guidance for industry entitled
``Bioequivalence Recommendations for Specific Products'' that explained
the process that would be used to make product-specific guidances
available to the public on FDA's website at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.
    As described in that guidance, FDA adopted this process as a means
to develop and disseminate product-specific guidances and provide a
meaningful opportunity for the public to consider and comment on those
guidances. Under that process, draft guidances are posted on FDA's
website and announced periodically in the Federal Register. The public
is encouraged to submit comments on those recommendations within 60
days of their announcement in the Federal Register. FDA considers any
comments received and either publishes final guidances or publishes
revised draft guidances for comment. Guidances were last announced in
the Federal Register on November 22, 2019. This notice announces draft
product-specific guidances, either new or revised, that are posted on
FDA's website.

II. Drug Products for Which New Draft Product-Specific Guidances Are
Available

    FDA is announcing the availability of new draft product-specific
guidances for industry for drug products containing the following
active ingredients:

     Table 1--New Draft Product-Specific Guidances for Drug Products
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                          Active ingredient(s)
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Albuterol sulfate.
Amifampridine phosphate.
Amino acids; Calcium chloride; Dextrose; Magnesium sulfate; Potassium
 chloride; Sodium acetate; Sodium glycerophosphate; Soybean oil.
Besifloxacin hydrochloride.
Binimetinib.
Budesonide.
Clevidipine.
Dacomitinib.
Dapagliflozin; Metformin hydrochloride; Saxagliptin hydrochloride.
Diltiazem hydrochloride.
Doravirine.
Doravirine; Lamivudine; Tenofovir disoproxil fumarate.
Duloxetine hydrochloride.
Edaravone.
Elagolix sodium.
Granisetron.
Ivacaftor; Lumacaftor.
Liraglutide recombinant.
Lusutrombopag.
Mexiletine hydrochloride.
Moxidectin.
Propranolol hydrochloride.
Rifamycin sodium.
Selenious acid.
Semaglutide.
Stiripentol (multiple reference listed drugs).
Sumatriptan succinate.
Tacrolimus.
Tiopronin.
Tolvaptan.
Umeclidinium bromide; Vilanterol trifenatate.
Upadacitinib.
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III. Drug Products for Which Revised Draft Product-Specific Guidances
Are Available

    FDA is announcing the availability of revised draft product-
specific guidances for industry for drug products containing the
following active ingredients:

   Table 2--Revised Draft Product-Specific Guidances for Drug Products
------------------------------------------------------------------------
                          Active ingredient(s)
-------------------------------------------------------------------------
Albuterol sulfate (multiple reference listed drugs).
Beclomethasone dipropionate.
Calcitonin salmon.
Dapagliflozin; Metformin hydrochloride.
Edoxaban tosylate.
Ibrutinib.
Levalbuterol tartrate.
Olsalazine sodium.
Selexipag.
------------------------------------------------------------------------

    For a complete history of previously published Federal Register
notices related to product-specific guidances, go to https://www.regulations.gov and enter Docket No. FDA-2007-D-0369.
    These draft guidances are being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). These draft guidances,
when finalized, will represent the current thinking of FDA on, among
other things, the product-specific design of BE studies to support
ANDAs. They do not establish any rights for any person and are not
binding on FDA or the public. You can use an alternative approach if it
satisfies the requirements of the applicable statutes and regulations.

IV. Electronic Access

    Persons with access to the internet may obtain the draft guidances
at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or
https://www.regulations.gov.

    Dated: February 24, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-04320 Filed 3-2-20; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: November 7, 2008 (Volume 73, Number 217)]
[Notices]
[Page 66279-66281]
[DOCID:fr07no08-92]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-58888; File No. SR-NYSEArca-2008-100]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change Relating to Rules
6.100 and 6.82

October 30, 2008.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that on October 20, 2008, NYSE Arca, Inc. (``NYSE Arca'' or the
``Exchange''), filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I and II
below, which Items have been prepared by the self-regulatory
organization. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    NYSE Arca proposes to amend its rules governing Allocation of
Options Issues and Lead Market Maker (``LMM'') Evaluations. The
Exchange proposes to eliminate Rule 6.100 and revise Rule 6.82. The
text of the proposed rule change is available on the Exchange's Web
site at http://www.nyse.com, at the Exchange's principal office and at
the Public Reference Room of the Commission.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the self-regulatory organization
included statements concerning the purpose of and basis for the
proposed rule change. The text of these statements may be examined at
the places specified in Item IV below. The self-regulatory organization
has prepared summaries, set forth in sections A, B, and C below, of the
most significant aspects of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The purpose of this filing is to delete certain obsolete provisions
of Rule 6.100. The Exchange then proposes to incorporate the remaining
relevant provisions of Rule 6.100 into a revised Rule 6.82, so that all
relevant provisions related to LMM issue allocation reside within one
consolidated rule. Finally, the Exchange proposes to add new relevant
provisions to Rule 6.82 and logically renumber the Rule.

History

    Rule 6.100 was originally adopted from Options Floor Procedural
Advice (``OFPA'') \4\ B13, issued on April 2, 1988, which described
Trading Crowd evaluations and the process for allocating option issues.
On October 3, 1996, the Exchange revised OFPA-B13 to describe the
process for evaluating LMMs for purposes of allocating option issues.
OFPA-B13 was ultimately incorporated into the Exchange's rules, as part
of SR-PCX-1999-48.\5\
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    \4\ OFPAs were previously issued by the Exchange as a way of
distributing information such as committee decisions, policies and
procedures, and rule interpretations. Such information is now
conveyed through the issuance of Regulatory Bulletins.
    \5\ See Securities Exchange Act Release No. 44345 (May 23,
2001), 66 FR 30037 (June 4, 2001) (approval notice for SR-PCX-1999-
48).
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    Prior to the Exchange's conversion to its Lead Market Maker system
(a conversion which is now 100% complete), options issues, or classes
of options, on NYSE Arca were allocated to either a Trading Crowd,
consisting of a group of individual Market Makers, or to LMMs. An
allocation to a Trading Crowd simply designated the physical post on
the trading floor where a particular issue would trade. Traditionally,
a Market Maker's Appointment was generally limited to issues allocated
to a particular Trading Crowd.\6\ The allocation did not convey any
specific rights, nor confer any specific obligations on any individual
Market Maker of the crowd, other than those already specified in NYSE
Arca 6.37.\7\ A Market Maker's obligations, conveyed as a condition of
his or her Appointment, are not affected due to the allocation, or
reallocation of an options issue. An allocation of a particular class
of options to an LMM, which in turn becomes part of that Market Maker's
Appointment, does however guarantee certain rights, in return for
fulfilling certain obligations. Presently, these obligations and rights
are detailed, in part, in Rule 6.82.
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    \6\ Market Maker Appointments are governed by NYSE Arca Rule
6.35. Since the advent of electronic access to the Exchange in 2003,
a Market Maker's ``Appointment'' is no longer necessarily bound by
the physical layout of the Trading Floor.
    \7\ See NYSE Arca Rule 6.37 (Obligations of Market Makers).
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    By the end of the period in which the Exchange allocated issues to
both LMMs and Trading Crowds, the Exchange determined that most issues
that were allocated to an LMM (as opposed to a Trading Crowd) had
tighter bid/ask spreads, offered more liquidity and were generally
thought to offer a better product for public investors. As a result,
since 1999, all option issues on the Exchange have been allocated
exclusively to LMMs.\8\ Presently, there are no issues allocated to a
Trading Crowd.
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    \8\ It should be noted that in mid-2007 the Exchange received
approval to designate certain option issues as ``non-LMM'' issues.
See Securities Exchange Act Release No. 56001 (July 2, 2007), 72 FR
37557 (July 10, 2007) (SR-NYSEArca-2007-34). To qualify for non-LMM
status, the option issues must be highly liquid, highly active
issues that have sufficient participation by OTP Holders that there
is no need for an LMM. By their very definition, non-LMM issues are
not allocated to an LMM, nor are they allocated to a Trading Crowd.
The proposed changes described herein do not encompass or otherwise
impact non-LMM issues.
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Delete Obsolete Provisions of Rule 6.100

    Rule 6.100(b)-(c). The Exchange proposes to eliminate Rules
6.100(b)-(c) that relate solely to Trading Crowd questionnaires and
evaluations. As described above, since options issues are no longer
allocated to Trading Crowds, these rules are obsolete and unnecessary.
    Rule 6.100(d)-(g). The Exchange proposes to eliminate Rules
6.100(d)-(g)

that establish certain procedures related to informal meetings
regarding LMM evaluations. The Exchange, however, will retain certain
procedures related to informal hearings regarding LMM evaluations. As
set forth more fully below, in a revised Rule 6.82(g), the Exchange may
afford LMMs an opportunity to informal hearings prior to a final
determination regarding their performance--consistent with the current
rule. The Exchange will also afford LMMs an opportunity to appeal
allocation decisions pursuant to the Exchange's formal appeals process
codified in Rule 10.14.

Delete Obsolete Provisions of Rule 6.82

    Rule 6.82(a)(1) Lead Market Maker Defined. The Exchange proposes to
remove the reference to ``nominee.'' The concept of nominee, as it
pertains to the definition of LMMs, is obsolete and unnecessarily
confusing. To clarify who must be registered with the Exchange as a
Market Maker, the Exchange is replacing the reference to ``nominee''
and will refer instead to individuals trading on behalf of the LMM, as
follows: Each individual trading on behalf of an LMM must be registered
with the Exchange as a Market Maker or Market Maker Authorized Trader.
    Rule 6.82(e)(1) Allocation. The Exchange proposes to delete the
obsolete and unnecessary reference to ``trading crowd''. The Exchange
also proposes to remove the reference to ``Rule 6.100'' and replace it
with a reference to ``subparagraph (g) of this Rule''. As described
more fully below, this change relates to the Exchange's effort to
consolidate all provisions relating to issue allocation into one rule.
    Rule 6.82(e)(2) Transfer of Issues. The Exchange proposes removing
the reference to ``nominees.'' The reference to nominees is historic
and obsolete. Since issues are allocated to LMMs and not to nominees,
this restriction on transferring issues between nominees is both
confusing and unnecessary.
    Rule 6.82(e)(3) Evaluation of LMMs. The Exchange proposes to
eliminate this provision and replace it with a revised Rule 6.82(g),
which will incorporate Rule 6.82(e)(3) as well as certain provision of
Rule 6.100. As set forth more fully below, the revised Rule 6.82(g)
will clarify the performance standards by which LMMs will be evaluated,
the process by which LMMs will be evaluated, and the LMMs' right to
appeal such evaluation.
    Rule 6.82(f)(1) Reallocation. The Exchange proposes to remove
obsolete references to Trading Crowds and Nominees. The Exchange is not
otherwise amending or altering the substance of this rule.
    Rule 6.82(f)(2) Continued Quality and Service. The Exchange
proposes to eliminate Rule 6.82(f)(2), which governs the reallocation
of issues to the Market Maker system (Trading Crowd). Since option
issues are no longer allocated to Trading Crowds, this provision is
obsolete and unnecessary.
    Rule 6.82(f)(3) LMM Compensation. The Exchange also proposes to
eliminate Rule 6.82(f)(3), which states that in the event an LMM has an
option issue(s) reallocated, the Exchange may award compensation to
that LMM based on various factors. Option issues are generally
reallocated in situations where LMMs either fail to meet certain
performance standards or have been otherwise disqualified to act as an
LMM by the Exchange. As a result, the Exchange has determined that
compensating LMMs in these circumstances is not appropriate and
therefore proposes to eliminate this provision.
    Rule 6.82(g) Review of Exchange Decisions. The Exchange proposes
remove Rule 6.82(g), which generally sets forth that a LMM may appeal
allocation decisions pursuant to Rule 10. In its place, the Exchange
proposes to add new Rule 6.82(b)(5), which affords LMMs an opportunity
to appeal allocation decisions pursuant to the Exchange's formal
appeals process codified in Rule 10.14.

Move the Remaining Relevant Provisions of Rule 6.100 to Rule 6.82

    NYSE Arca proposes to move the remaining relevant portions of Rule
6.100 to new Rule 6.82(g). This will eliminate all text associated with
Rule 6.100. The Exchange also proposes to amend certain procedures
contained in Rule 6.82 and eliminate confusing references to historic
practices as detailed below.
    The Exchange proposes moving Rule 6.100(a) Evaluation of Options
Trading Crowd Performance to new Rule 6.82(g)(1) and renaming the Rule:
Evaluation of Lead Market Maker Performance. In addition to renumbering
and renaming the rule, the Exchange will clarify the performance
standards by which LMMs will be evaluated, the process by which LMMs
will be evaluated, and the LMMs' right to appeal such evaluation. Upon
revision, this provision will combine, in one rule, certain relevant
aspects of Rule 6.82(e)(3), as well as certain relevant provisions of
Rule 6.100. Relevant criteria such as quality of markets and adherence
to ethical standards remain. On the other hand, items such as
competition among Market Makers, which was a criterion used solely in
connection with allocating issues to a Trading Crowd is no longer
relevant and will be deleted. In addition, all references to Trading
Crowd evaluations and questionnaires will be removed since they are
obsolete an unnecessary.\9\
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    \9\ The Exchange notes that while Market Makers will no longer
be evaluated for purposes of participating in a Trading Crowd,
Market Makers will continue to be evaluated as a condition of their
Appointment under Rule 6.35(j). The Exchange will periodically
evaluate LMMs, in practice this may be as frequent as monthly and no
less than semiannually. The Exchange notes, that pursuant to Rule
6.41, the Exchange provides Market Makers, on a monthly basis, with
statistical reports designed to measure trading volume and
participation in trading activity in each option issue traded on the
Exchange.
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Add New Relevant Provisions to Rule 6.82

    Rule 6.82(b)(5) Appeals. As Described above, the Exchange proposes
adding this new provision which replaces Rule 6.82(g)(1) and affords
LMMs an opportunity to appeal allocation decisions pursuant to the
Exchange's formal appeals process codified in Rule 10.14.
    Rule 6.82(g)(1)(A). The Exchange proposes adding new Rule
6.82(g)(1)(A), which explains how NYSE Arca market share shall be
calculated. A minimum percentage of total national market volume shall
be established at the time an issue is allocated and will be identified
on the Request for Issue Allocation form that an LMM is required to
complete.\10\ Failure to maintain the minimum percentage of national
volume identified and agreed to at the time the issue is allocated to
the LMM will be considered a failure to meet minimum performance
standards.
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    \10\ Presently, the standard minimum acceptable total national
market volume is 5%. The Exchange determines this minimum acceptable
percentage based on NYSE Arca's percentage of total national
contract volume per security.
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    Rule 6.82(g)(1)(B). The Exchange proposes adding new Rule
6.82(g)(1)(B), which states that the Exchange will provide LMMs with
information related to their national market share in each of their
allocated issues. According to the new provision, LMMs shall have the
ability to meet with Exchange staff, upon request, to discuss such
findings.
    Rule 6.82(g)(1)(C). The Exchange proposes adding new Rule
6.82(g)(1)(C), which outlines the informal hearing process the Exchange
may undertake in the event an LMM has failed to meet performance
standards pursuant Rule 6.82(g)(1). This section is generally
consistent with current Rule 6.100(e)-(f) and (h).

    Rule 6.82(g)(1)(D). The Exchange proposes adding new Rule
6.82(g)(1)(D), which outlines the process the Exchange will undertake
in the event an LMM has failed to meet performance standards pursuant
Rule 6.82(g)(1), including the right to appeal pursuant to Rule 10.14.

Conclusion

    NYSE Arca Rules 6.100 and 6.82 contain numerous obsolete and
outdated provisions. The Exchange proposes eliminating those obsolete
provisions of Rules 6.100 and 6.82 and renumbering the remaining
relevant provisions of Rule 6.100 as part of the newly reconstituted
Rule 6.82. The Exchange also proposes to add new relevant rules
pertaining to the allocation of option issues and the evaluation of
LMMs. Taken together, these changes will simplify and clarify the
Exchange's rules regarding option issues allocation.
2. Statutory Basis
    The proposed rule change is consistent with Section 6(b) \11\ of
the Act, in general, and furthers the objectives of Section
6(b)(5),\12\ in particular, in that it is designed to prevent
fraudulent and manipulative acts and practices, to promote just and
equitable principles of trade, to foster cooperation and coordination
with persons engaged in facilitating transactions in securities, and to
remove impediments to and perfect the mechanisms of a free and open
market and a national market system. The Exchange proposes eliminating
obsolete provisions of Rules 6.100 and 6.82 while adding new relevant
rules pertaining to the allocation of option issues and the evaluation
of LMMs. Taken together, these changes will simplify and clarify the
Exchange's rules regarding option issues allocation.
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    \11\ 15 U.S.C. 78f(b).
    \12\ 15 U.S.C. 78f(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants or Others

    The Exchange has neither solicited nor received written comments on
the proposed rule change.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    The Exchange has filed the proposed rule change pursuant to Section
19(b)(3)(A)(iii) of the Act \13\ and Rule 19b-4(f)(6) thereunder.\14\
Because the proposed rule change does not: (i) Significantly affect the
protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) become operative prior to
30 days from the date on which it was filed, or such shorter time as
the Commission may designate if consistent with the protection of
investors and the public interest, the proposed rule change has become
effective pursuant to Section 19(b)(3)(A) of the Act \15\ and Rule 19b-
4(f)(6)(iii) thereunder.\16\
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    \13\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \14\ 17 CFR 240.19b-4(f)(6).
    \15\ 15 U.S.C. 78s(b)(3)(A).
    \16\ 17 CFR 240.19b-4(f)(6)(iii). In addition, Rule 19b-
4(f)(6)(iii) requires the Exchange to give the Commission written
notice of the Exchange's intent to file the proposed rule change
along with a brief description and the text of the proposed rule
change, at least five business days prior to the date of filing of
the proposed rule change, or such shorter time as designated by the
Commission. The Exchange has satisfied the pre-filing requirement.
---------------------------------------------------------------------------

    The Exchange further asserts that the proposed changes simply serve
to clarify the rules of NYSE Arca regarding option issues allocation by
eliminating obsolete provisions of Rules 6.100 and 6.82 while adding
new relevant rules pertaining to the allocation of option issues and
the evaluation of LMMs. For the foregoing reasons, the Exchange has
designated this rule filing as a ``non-controversial'' rule change
under paragraph (f)(6) of Rule 19b-4.\17\
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    \17\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission may summarily abrogate such rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors, or otherwise
in furtherance of the purposes of the Act.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-NYSEArca-2008-100 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street, NE., Washington, DC 20549-1090.

All submissions should refer to File Number SR-NYSEArca-2008-100. This
file number should be included on the subject line if e-mail is used.
To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/
rules/sro.shtml). Copies of the submission, all subsequent amendments,
all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for inspection
and copying in the Commission's Public Reference Room, 100 F Street,
NE., Washington, DC 20549, on official business days between the hours
of 10 a.m. and 3 p.m. Copies of the filing also will be available for
inspection and copying at the principal office of the self-regulatory
organization. All comments received will be posted without change; the
Commission does not edit personal identifying information from
submissions. You should submit only information that you wish to make
available publicly. All submissions should refer to File Number SR-
NYSEArca-2008-100 and should be submitted on or before November 28,
2008.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\18\
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    \18\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Acting Secretary.
 [FR Doc. E8-26571 Filed 11-6-08; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register Volume 82, Number 195 (Wednesday, October 11, 2017)]
[Notices]
[Pages 47299-47300]
[FR Doc No: 2017-21881]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2017-0181]

Qualification of Drivers; Exemption Applications; Epilepsy and
Seizure Disorders

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of applications for exemption; request for comments.

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SUMMARY: FMCSA announces receipt of applications from five individuals
for an exemption from the prohibition in the Federal Motor Carrier
Safety Regulations (FMCSRs) against persons with a clinical diagnosis
of epilepsy or any other condition that is likely to cause a loss of
consciousness or any loss of ability to control a commercial motor
vehicle (CMV) to drive in interstate commerce. If granted, the
exemptions would enable these individuals who have had one or more
seizures and are taking anti-seizure medication to operate CMVs in
interstate commerce.

DATES: Comments must be received on or before November 13, 2017.

ADDRESSES: You may submit comments bearing the Federal Docket
Management System (FDMS) Docket No. FMCSA-2017-0181 using any of the
following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the online instructions for submitting
comments.
     Mail: Docket Management Facility; U.S. Department of
Transportation, 1200 New Jersey Avenue SE., West Building Ground Floor,
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery: West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m.,
ET, Monday through Friday, except Federal Holidays.
     Fax: 1-202-493-2251.
    Instructions: Each submission must include the Agency name and the
docket number(s) for this notice. Note that all comments received will
be posted without change to http://www.regulations.gov, including any
personal information provided. Please see the Privacy Act heading below
for further information.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov at any time or Room W12-140
on the ground level of the West Building, 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., ET, Monday through Friday,
except Federal holidays. The FDMS is available 24 hours each day, 365
days each year. If you want acknowledgment that we received your
comments, please include a self-addressed, stamped envelope or postcard
or print the acknowledgement page that appears after submitting
comments online.
    Privacy Act: In accordance with 5 U.S.C. 553(c), DOT solicits
comments from the public to better inform its rulemaking process. DOT
posts these comments, without edit, including any personal information
the commenter provides, to http://www.regulations.gov, as described in
the system of records notice (DOT/ALL-14 FDMS), which can be reviewed
at http://www.dot.gov/privacy.

FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, Chief,
Medical Programs Division,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA,
Department of Transportation, 1200 New Jersey Avenue SE., Room W64-224,
Washington, DC 20590-0001. Office hours are 8:30 a.m. to 5 p.m., ET,
Monday through Friday, except Federal holidays. If you have questions
regarding viewing or submitting material to the docket, contact Docket
Services, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
from the FMCSRs for a five-year period if it finds ``such exemption
would likely achieve a level of safety that is equivalent to or greater
than the level that would be achieved absent such exemption.'' The
statute also allows the Agency to renew exemptions at the end of the
five-year period. FMCSA grants exemptions from the FMCSRs for a two-
year period to align with the maximum duration of a driver's medical
certification.
    The five individuals listed in this notice have requested an
exemption from the epilepsy and seizure disorders prohibition in 49 CFR
391.41(b)(8). Accordingly, the Agency will evaluate the qualifications
of each applicant to determine whether granting the exemption will
achieve the required level of safety mandated by statute.
    The physical qualification standard for drivers regarding epilepsy
found in 49 CFR 391.41(b)(8) states that a person is physically
qualified to drive a CMV if that person:

    Has no established medical history or clinical diagnosis of
epilepsy or any other condition which is likely to cause the loss of
consciousness or any loss of ability to control a CMV.

    In addition to the regulations, FMCSA has published advisory
criteria \1\ to assist Medical Examiners in determining whether drivers
with certain medical conditions are qualified to operate a CMV in
interstate commerce. [49 CFR part 391, APPENDIX A TO PART 391--MEDICAL
ADVISORY CRITERIA, section H. Epilepsy: Sec.  391.41(b)(8), paragraphs
3, 4, and 5.]
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    \1\ See http://www.ecfr.gov/cgi-bin/text-idx?SID=e47b48a9ea42dd67d999246e23d97970&mc=true&node=pt49.5.391&rgn=div5#ap49.5.391_171.a and https://www.gpo.gov/fdsys/pkg/CFR-2015-title49-vol5/pdf/CFR-2015-title49-vol5-part391-appA.pdf.
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    The advisory criteria states the following:
    If an individual has had a sudden episode of a non-epileptic
seizure or loss of consciousness of unknown cause that did not require
anti-seizure medication, the decision whether that person's condition
is likely to cause the loss of consciousness or loss of ability to
control a CMV should be made on an individual basis by the Medical
Examiner in consultation with the treating physician. Before
certification is considered, it is suggested that a six-month waiting
period elapse from the time of the episode. Following the waiting
period, it is suggested that the individual have a complete
neurological examination. If the results of the examination are
negative and anti-seizure medication is not required, then the driver
may be qualified.
    In those individual cases where a driver had a seizure or an
episode of loss of consciousness that resulted from a known medical
condition (e.g., drug reaction, high temperature, acute infectious
disease, dehydration, or acute metabolic disturbance), certification
should be deferred until the driver has recovered fully from that
condition, has no existing residual complications, and is not taking
anti-seizure medication.
    Drivers who have a history of epilepsy/seizures, off anti-seizure
medication and seizure-free for 10 years, may be qualified to operate a
CMV in interstate commerce. Interstate drivers with a history of a
single unprovoked seizure may be qualified to drive a CMV in interstate
commerce if seizure-free and off anti-seizure medication for a five-
year period or more.
    As a result of Medical Examiners misinterpreting advisory criteria
as regulation, numerous drivers have been prohibited from operating a
CMV in interstate commerce based on the fact that they have had one or
more seizures

and are taking anti-seizure medication, rather than an individual
analysis of their circumstances by a qualified Medical Examiner based
on the physical qualification standards and medical best practices.
    On January 15, 2013, FMCSA announced in a Notice of Final
Disposition titled, Qualification of Drivers; Exemption Applications;
Epilepsy and Seizure Disorders, (78 FR 3069), its decision to grant
requests from 22 individuals for exemptions from the regulatory
requirement that interstate CMV drivers have ``no established medical
history or clinical diagnosis of epilepsy or any other condition which
is likely to cause loss of consciousness or any loss of ability to
control a CMV.'' Since the January 15, 2013 notice, the Agency has
published additional notices granting requests from individuals for
exemptions from the regulatory requirement regarding epilepsy found in
49 CFR 391.41(b)(8).
    To be considered for an exemption from the epilepsy and seizure
disorders prohibition in 49 CFR 391.41(b)(8), applicants must meet the
criteria in the 2007 recommendations of the Agency's Medical Expert
Panel (MEP) (78 FR 3069).

II. Qualifications of Applicants

Gary T. Clark

    Mr. Clark is a 44-year old Class A driver in Kentucky. He has a
history of epilepsy and has remained seizure free since 2006. He takes
anti-seizure medication, with the dosage and frequency remaining the
same since 2015. His physician states that he is supportive of Mr.
Clark receiving an exemption.

Gary J. Gress

    Mr. Gress is a 58-year old Class AM driver in Pennsylvania. He has
a history of post traumatic seizure due to traumatic brain injury and
has remained seizure free since 2003. He takes anti-seizure medication,
with the dosage and frequency remaining the same since that time. His
physician states that he is supportive of Mr. Gress receiving an
exemption.

Joseph R. Lamkin

    Mr. Lamkin is a 47-year old Class DB driver in Kentucky. He has a
history of multiple past generalized seizures and has remained seizure
free since 1998. He takes anti-seizure medications, with the dosage and
frequency remaining the same since 2007. His physician states that he
is supportive of Mr. Lamkin receiving an exemption.

Kenneth L. Lewis

    Mr. Lewis is a 55-year old Class A driver in North Carolina. He has
a history of epilepsy and has remained seizure free since 1984. He
takes anti-seizure medication, with the dosage and frequency remaining
the same since 2004. His physician states that he is supportive of Mr.
Lewis receiving an exemption.

Sean C. Moran

    Mr. Moran is a 22-year old Class D driver in Massachusetts. He has
a history of epilepsy and has remained seizure free since 2009. He
takes anti-seizure medication, with the dosage and frequency remaining
the same since 2010. His physician states that he is supportive of Mr.
Moran receiving an exemption.

III. Request for Comments

    In accordance with 49 U.S.C. 31136(e) and 31315, FMCSA requests
public comment from all interested persons on the exemption petitions
described in this notice. We will consider all comments received before
the close of business on the closing date indicated in the dates
section of the notice.

IV. Submitting Comments

    You may submit your comments and material online or by fax, mail,
or hand delivery, but please use only one of these means. FMCSA
recommends that you include your name and a mailing address, an email
address, or a phone number in the body of your document so that FMCSA
can contact you if there are questions regarding your submission.
    To submit your comment online, go to http://www.regulations.gov and
in the search box insert the docket number FMCSA-2017-0181 and click
the search button. When the new screen appears, click on the blue
``Comment Now!'' button on the right hand side of the page. On the new
page, enter information required including the specific section of this
document to which each comment applies, and provide a reason for each
suggestion or recommendation. If you submit your comments by mail or
hand delivery, submit them in an unbound format, no larger than 8\1/2\
by 11 inches, suitable for copying and electronic filing. If you submit
comments by mail and would like to know that they reached the facility,
please enclose a stamped, self-addressed postcard or envelope.
    We will consider all comments and materials received during the
comment period. FMCSA may issue a final determination at any time after
the close of the comment period.

V. Viewing Comments and Documents

    To view comments, as well as any documents mentioned in this
preamble, go to http://www.regulations.gov and in the search box insert
the docket number FMCSA-2017-0181 and click ``Search.'' Next, click
``Open Docket Folder'' and you will find all documents and comments
related to this notice.

    Issued on: October 2, 2017.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2017-21881 Filed 10-10-17; 8:45 am]
 BILLING CODE 4910-EX-P


[Federal Register Volume 76, Number 214 (Friday, November 4, 2011)]
[Rules and Regulations]
[Pages 68301-68304]
[FR Doc No: 2011-28355]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2011-1182; Directorate Identifier 2010-SW-010-AD;
Amendment 39-16853; AD 2011-23-02]
RIN 2120-AA64

Airworthiness Directives; Bell Helicopter Textron, Inc. (Bell),
Model 205A-1, 205B, 210, and 212 Helicopters

AGENCY: Federal Aviation Administration, DOT.

ACTION: Final rule; request for comments.

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SUMMARY: This amendment supersedes an existing airworthiness directive
(AD) for Bell Model 205B and 212 helicopters with certain main rotor
blade (blade) assemblies installed. That AD currently requires washing
the upper and lower surfaces of each blade and visually inspecting the
grip plates, doublers, and the remaining upper and lower surfaces of
the blades in the area between blade stations 24.5 to 40 for an edge
void, corrosion, or a crack. This amendment retains the requirements of
that AD for the affected part-numbered blades but increases the scope
and frequency of the inspections and expands the applicability to
include the Model 205A-1 and 210 helicopters, additional blade part
numbers, and all helicopter serial numbers for the affected helicopter
models. This amendment also requires applying a light coat of
preservative oil (C-125) to all surfaces of the blade in addition to
the inspection areas as required in the existing AD. This amendment is
prompted by an additional report of a fatigue crack on a blade
installed on a Model 212 helicopter. The actions specified by this AD
are intended to detect an edge void, corrosion, or a crack on a blade,
and to prevent loss of a blade and subsequent loss of control of the
helicopter.

DATES: Effective November 21, 2011.
    The incorporation by reference of certain publications listed in
the regulations is approved by the Director of the Federal Register as
of November 21, 2011.
    We must receive comments on this AD by January 3, 2012.

ADDRESSES: Use one of the following addresses to comment on this AD.
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: 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 Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
    You may get the service information identified in this AD from Bell
Helicopter Textron, Inc., P.O. Box 482, Fort Worth, TX 76101, telephone
(817) 280-3391, fax<PHONE_NUMBER>, or at http://www.bellcustomer.com/files/.
    Examining the Docket: You may examine the docket that contains the
AD, any comments, and other information on the Internet at http://www.regulations.gov, or in person at the Docket Operations office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The Docket Operations office (telephone<PHONE_NUMBER>) is
located in Room W12-140 on the ground floor of the West Building at the
street address stated in the ADDRESSES section. Comments will be
available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Michael Kohner, Aviation Safety
Engineer, FAA, Rotorcraft Directorate, Rotorcraft Certification Office,
2601 Meacham Blvd., Fort Worth, Texas 76137, telephone<PHONE_NUMBER>,
fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: On December 21, 2009, we issued AD 2010-03-
03, Amendment 39-16186 (75 FR 5681, February 4, 2010), to require at
specified intervals washing the upper and lower surfaces of each blade
and visually inspecting the grip plates, doublers, and the remaining
upper and lower surfaces of the blades in the area from blade stations
24.5 to 40 for an edge void, corrosion, or a crack using a 3x power or
higher magnifying glass. That AD was prompted by two reports of fatigue
cracks on blades installed on Model 212 helicopters. The cause of the
cracks has been attributed to inadequate adhesive bonding during
manufacture in the area between the grip plate and mating doubler
surface. A crack first appears in the grip plate, which can be detected
visually with the blade installed on the helicopter. That condition, if
not detected, could result in loss of a blade and subsequent loss of
control of the helicopter.
    Since issuing AD 2010-03-03 (75 FR 5681, February 4, 2010), we have
received another report of a fatigue crack on a blade installed on a
Model 212 helicopter. The crack at the blade

attachment bolt hole has been attributed to a large disbond, which
developed in the adhesive between the lower grip plate and mating
doubler. The lower grip plate was not cracked. The disbond initiated at
the tip of the grip plate and propagated to the blade attachment bolt
hole. Corrosion was found on the doubler suggesting an edge void was
present for an extended amount of time and went undetected by the
inspections being performed by the operator. Further analysis and
investigation by the manufacturer have revealed that the inspections on
the blade as required by the current AD need to be expanded and
performed at an increased frequency and on additional part-numbered
blades of similar design and manufacture, which can also be installed
on the Model 210 and 212 helicopters.
    We have also determined that blade part numbers listed in the
current AD may also be installed on Model 205A-1 helicopters modified
in accordance with Supplemental Type Certificate (STC) No. SH5132NM or
SH5976NM. The affected blade can also be installed on all helicopter
serial numbers for the affected helicopter models. Therefore, this
amendment retains the same requirements as AD 2010-03-03 (75 FR 5681,
February 4, 2010) for the affected part-numbered blades but increases
the scope and frequency of the inspections and expands the
applicability to include the Model 205A-1 and 210 helicopters,
additional blade part numbers, and all helicopter serial numbers for
the affected helicopter models. Finally, after further investigation,
we discovered the requirement of the current AD to apply the oil only
to the specified inspection areas was not the original intent of the
AD. Therefore, this AD also requires applying a light coat of
preservative oil (C-125) to all surfaces of the blade to prevent
corrosion from the process of washing the blade surfaces in preparation
for the inspections in addition to those areas as required in the
current AD.
    We have reviewed Bell Helicopter Alert Service Bulletin (ASB) No.
205B-08-51 and ASB No. 212-08-130, both Revision B and dated January
11, 2011, applicable to Model 205B and Model 212 helicopters,
respectively, and ASB No. 210-08-03, Revision B, dated January 10,
2011, applicable to Model 210 helicopters, which describe procedures
for initial and repetitive inspections of certain part-numbered blades
on certain serial-numbered helicopters for signs of an edge void,
corrosion, or a crack, including a hair-line crack in the blade paint
finish in the inspection area as shown in Figure 1 of the ASBs between
blade stations 24.5 and 85.
    This AD differs from the ASBs as follows:
     We specifically require only wiping each of the bond lines
at the edges of both grip plates and each of the layered doublers (bond
lines) on the upper and lower surfaces of each affected blade with an
alcohol-soaked cloth. This is required immediately before performing a
visual inspection using a 3x or higher magnifying glass and a bright
light to detect an edge delamination along any of the bond lines. This
was done to avoid any possible confusion with having to wipe the entire
surface blade area from blade station 24.5 to 85, which could make
performing a reliable inspection difficult. The ASBs state to ``wipe
the area to be inspected with an alcohol-soaked cloth.''
     The ASBs use the phrase ``bond lines between doublers,
grip plates, and skin'' to describe the bond lines, and we use ``bond
lines at the edges of both grip plates and each of the layer
doublers.''
     The ASBs use the phrase ``cracks in the bond lines between
doublers or grip plates'' to describe a separation of the doubler or
grip plate along an edge, and we use the term ``edge delamination.''
     We do not specify each helicopter serial number (S/N) in
our AD; the ASBs do specify the helicopter S/Ns.
    Since an unsafe condition has been identified that is likely to
exist or develop on other helicopters of these same type designs, this
AD supersedes AD 2010-03-03 (75 FR 5681, February 4, 2010), retaining
the same requirements for the affected part-numbered blades but
increasing the scope and frequency of the inspections and expanding the
applicability to include the Model 205A-1 and 210 helicopters,
additional blade part numbers, and all helicopter serial numbers for
the affected helicopter models.
    The short compliance time involved is required because the
previously described critical unsafe condition can adversely affect the
structural integrity and controllability of the helicopter. Therefore,
the AD must be issued immediately to require the following actions
within 25 hours time-in-service (TIS) and thereafter at intervals not
to exceed 25 hours TIS:
     Washing the upper and lower blade surfaces using a
solution of cleaning compound (C-318) and water.
     Visually inspecting each of the upper and lower grip
plates and doublers of the blade for their entire length and chord
width for an edge void, any corrosion, or a crack.
     Wiping each of the bond lines at the edges of both grip
plates and each of the layered doublers (bond lines) on the upper and
lower surfaces of each affected blade with an alcohol-soaked cloth (C-
385) in the area from blade stations 24.5 to 85.
     Immediately thereafter, using a 3x power or higher
magnifying glass and a bright light, visually inspecting each of the
bond lines on the upper and lower surfaces of the blade in the
inspection area for any edge delamination, as indicated by a dark line
located along any bond line, or a crack in the paint finish.
     Applying a light coat of preservative oil (C-125) to all
surfaces of the blade.
     Removing paint from areas in which an edge delamination
along any bond line of a grip plate or doubler, or a crack in the blade
paint finish is discovered, by sanding with 180-220 grit paper to
determine if an edge void or a crack exists in the blade.
     Replacing any blade that has a crack in any grip plate or
doubler with an airworthy blade.
     Replacing any blade that has an edge void or any corrosion
with an airworthy blade or repairing the blade if the damage is within
the maximum repair damage limits. The maximum repair damage limitations
are contained in the applicable Component and Repair Overhaul Manual.
     Replacing any blade that has a crack in the blade skin
with an airworthy blade, or repairing the blade if the damage is within
the maximum repair damage limits.
    Since a situation exists that requires the immediate adoption of
this regulation, it is found that notice and opportunity for prior
public comment hereon are impracticable and that good cause exists for
making this amendment effective in less than 30 days.
    We estimate that this AD will affect 132 helicopters in the U.S.
registry. We also estimate that washing and visually inspecting each
blade will take about 1 work hour. If an edge void, corrosion, or a
crack is found, replacing a blade with an airworthy blade will take
about 24 work hours. The average labor rate is $85 per work hour.
Required parts will cost about $85,597 for a replacement blade. Based
on these figures, we estimate the total cost of the AD on U.S.
operators to be $356,917, assuming that 24 inspections are done each
year on each helicopter and that 1 blade is replaced.

Comments Invited

    This AD is a final rule that involves requirements affecting flight
safety, and

we did not precede it by notice and an opportunity for public comment.
We invite you to send any written relevant data, views, or arguments
regarding this AD. Send your comments to an address listed under the
ADDRESSES section. Include the docket number ``FAA-2011-1182;
Directorate Identifier 2010-SW-010-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of the AD. We will consider
all comments received by the closing date and may amend the AD in light
of those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive concerning this AD. Using the search function of the docket Web
site, you can find and read the comments to any of our dockets,
including the name of the individual who sent the comment. You may
review the DOT's complete Privacy Act Statement in the Federal Register
published on April 11, 2000 (65 FR 19477-78).

Regulatory Findings

    We have determined that this AD will not have federalism
implications under Executive Order 13132. This AD will not have a
substantial direct effect on the States, on the relationship between
the national Government and the States, or on the distribution of power
and responsibilities among the various levels of government.
    For the reasons discussed above, I certify that the regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979);
    3. Will not affect intrastate aviation in Alaska to the extent that
it justifies making a regulatory distinction; and
    4. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared an economic evaluation of the estimated costs to comply
with this AD. See the AD docket to examine the economic evaluation.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. 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.
    We are issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701, ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

     Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13   [Amended]

0
2. The FAA amends Sec.  39.13 by removing Airworthiness Directive (AD)
2010-03-03; Amendment 39-16186 (75 FR 5681, February 4, 2010), and by
adding a new AD to read as follows:

2011-23-02 Bell Helicopter Textron, Inc.: Amendment 39-16853; Docket
No. FAA-2011-1182; Directorate Identifier 2010-SW-010-AD. Supersedes
AD 2010-03-03, Amendment 39-16186 (75 FR 5681, February 4, 2010),
Docket No. FAA-2010-0065, Directorate Identifier 2009-SW-01-AD.

    Applicability: Model 205A-1, 205B, 210 and 212 helicopters with
a main rotor blade (blade), part number (P/N) 204-012-001-023 or -
033; 210-015-001-101; 212-015-501-005, -111, -113, -115, -117, -119,
or -121, installed, certificated in any category.

    Note 1:  Bell Helicopter Model 205A-1 helicopters, modified by
Supplemental Type Certificate (STC) No. SH5132NM or SH5976NM, may
have affected part-numbered blades installed.

    Compliance: Required as indicated.
    To detect an edge void, corrosion, or a crack on a blade, to
prevent the loss of a blade and subsequent loss of control of the
helicopter, do the following:
    (a) Within 25 hours time-in-service (TIS), unless accomplished
previously, and thereafter at intervals not to exceed 25 hours TIS:
    (1) Wash the upper and lower surfaces of each affected blade
with a solution of cleaning compound (C-318) and water. Rinse
thoroughly and wipe dry.
    (2) Visually inspect each of the upper and lower grip plates and
doublers of the blade for their entire length and chord width for an
edge void, any corrosion, or a crack. Pay particular attention to
any crack in the paint finish near or at a bond line that follows
the outline of a grip plate or doubler.

    Note 2:  The inspections required by paragraphs (a)(2) and
(a)(4) of this AD do not require removal of the blades from the main
rotor hub and can be accomplished while the blades are installed on
the helicopter.

    (3) Wipe each of the bond lines at the edges of both grip plates
and each of the layered doublers (bond lines) on the upper and lower
surfaces of each affected blade with an alcohol-soaked cloth (C-385)
in the area from blade stations 24.5 to 85 (inspection area) as
depicted in Figure 1 of Bell Helicopter Alert Service Bulletin (ASB)
No. 205B-08-51 for the Model 205B helicopters or ASB No. 212-08-130
for the Model 212 helicopters (and the Model 205A-1 helicopters),
both Revision B, and both dated January 11, 2011; or ASB No. 210-08-
03, Revision B, dated January 10, 2011, for the Model 210
helicopters, as appropriate for your model helicopter. Wipe dry with
a clean cloth.
    (4) Immediately after accomplishing paragraph (a)(3) of this AD,
using a 3x power or higher magnifying glass and a bright light,
visually inspect each of the bond lines on the upper and lower
surfaces of the blade in the inspection area for any edge
delamination, as indicated by a dark line located along any bond
line, or a crack in the paint finish. An edge delamination is
defined as a separation of the detail parts along an edge.

    Note 3:  An edge delamination along the edge of a grip plate or
doubler, or ``any potential cracks in the bond lines between
doublers or grip plates'' as described in the ASBs, is indicated by
the presence of excess alcohol bleeding out of an edge void. The
excess alcohol in the void will appear as a dark line along the bond
line. A crack in the paint finish which follows the outline of a
grip plate or doubler may indicate a possible edge void.

    (5) If there is no edge void, corrosion, crack, an edge
delamination, or a crack in the paint finish, apply a light coat of
preservative oil (C-125) to all surfaces of the blade.
    (b) Before further flight:
    (1) If there is any edge delamination along any bond line of a
grip plate or doubler, or a crack in the paint finish:
    (i) Remove the paint in the affected area by lightly sanding
with 180-220 grit paper in a span-wise direction to determine if
there is an edge void, or if the grip plate, doubler, or skin is
cracked. If any parent material is removed during the sanding
operation, replace the blade with an airworthy blade or repair the
blade if the amount of parent material removed is within the maximum
repair damage limits.

    Note 4:  The maximum repair damage limits are contained in the
applicable Component and Repair Overhaul Manual.

    (ii) If there is an edge void, determine the depth and length
using a .0015 inch feeler gauge.

    (iii) If there is an edge void in a grip plate or doubler near
the outboard tip, tap inspect the affected area to determine the
size and shape of the void.
    (iv) Repair the blade if the edge void is within the maximum
repair damage limits or replace the blade with an airworthy blade.
    (v) If there is not an edge void or a crack, refinish the sanded
area.
    (2) If there is a crack in any grip plate or doubler, replace
the blade with an airworthy blade.
    (3) If there is a crack in the blade skin, replace the blade
with an airworthy blade, or repair the blade if the damage is within
the maximum repair damage limits.
    (4) If there is any corrosion, replace the blade with an
airworthy blade or repair the blade if the damage is within the
maximum repair damage limits.
    (c) To request a different method of compliance or a different
compliance time for this AD, follow the procedures in 14 CFR 39.19.
Contact the Manager, Rotorcraft Certification Office, Attn: Michael
Kohner, Aviation Safety Engineer, FAA, Rotorcraft Directorate, 2601
Meacham Blvd., Fort Worth, Texas 76137, telephone<PHONE_NUMBER>,
fax<PHONE_NUMBER>, for information about previously approved
alternative methods of compliance.
    (d) The inspection area is depicted in Figure 1 of Bell
Helicopter Alert Service Bulletin No. 205B-08-51 or No. 212-08-130,
both Revision B, and both dated January 11, 2011; or No. 210-08-03,
Revision B, dated January 10, 2011. The incorporation by reference
of these documents was approved by the Director of the Federal
Register, in accordance with 5 U.S.C. 552(a) and 1 CFR part 51.
Copies may be obtained from Bell Helicopter Textron, Inc., P.O. Box
482, Fort Worth, TX 76101, telephone<PHONE_NUMBER>, fax (817) 280-
6466, or at http://www.bellcustomer.com/files/. Copies may be
inspected at the FAA, Office of the Regional Counsel, Southwest
Region, 2601 Meacham Blvd., Room 663, Fort Worth, Texas, or at the
National Archives and Records Administration (NARA). For information
on the availability of this material at NARA, call<PHONE_NUMBER>,
or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

Joint Aircraft System/Component (JASC) Code

    (e) The JASC Code is 6210: Main Rotor Blades.
    (f) This amendment becomes effective on November 21, 2011.

    Issued in Fort Worth, Texas, on October 21, 2011.
Lance T. Gant,
Acting Manager, Rotorcraft Directorate, Aircraft Certification Service.
[FR Doc. 2011-28355 Filed 11-3-11; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: November 5, 2008 (Volume 73, Number 215)]
[Notices]
[Page 65870]
[DOCID:fr05no08-74]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[FEMA-1791-DR]

Texas; Amendment No. 10 to Notice of a Major Disaster Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Texas (FEMA-1791-DR), dated September 13, 2008, and
related determinations.

DATES: Effective Date: October 24, 2008.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Disaster Assistance
Directorate, Federal Emergency Management Agency, 500 C Street, SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the State of Texas is hereby amended to include the following areas
among those areas determined to have been adversely affected by the
catastrophe declared a major disaster by the President in his
declaration of September 13, 2008.

    Anderson, Bowie, Leon, and Milam Counties for Public Assistance.
    Grimes, Jasper, Jefferson, Nacogdoches, San Jacinto, Walker, and
Waller Counties for Public Assistance [Categories C-G] (already
designated for Individual Assistance and debris removal and
emergency protective measures [Categories A and B], including direct
Federal assistance, under the Public Assistance program).

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

R. David Paulison,
Administrator, Federal Emergency Management Agency.
[FR Doc. E8-26302 Filed 11-4-08; 8:45 am]

BILLING CODE 9111-23-P


[Federal Register Volume 80, Number 160 (Wednesday, August 19, 2015)]
[Notices]
[Pages 50356-50358]
[FR Doc No: 2015-20410]

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SECURITIES AND EXCHANGE COMMISSION

[Investment Company Act Release No. 31758; 812-14352]

FEG Absolute Access TEI Fund LLC and FEG Investors, LLC; Notice
of Application

August 13, 2015.
AGENCY:  Securities and Exchange Commission (``Commission'').

ACTION:  Notice of an application under section 6(c) of the Investment
Company Act of 1940 (the ``Act'') for an exemption from sections 18(c)
and 18(i) of the Act and for an order pursuant to section 17(d) of the
Act and rule 17d-1 under the Act.

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Summary of Application: Applicants request an order to permit certain
registered closed-end management investment companies to issue multiple
classes of limited liability company units (``Units'') with sales loads
and/or asset-based distribution and/or service fees and contingent
deferred sales loads (``CDSCs'').

Applicants: FEG Absolute Access TEI Fund LLC (the ``Fund''), FEG
Absolute Access Fund LLC (the ``Master Fund''), and FEG Investors, LLC
(the ``Adviser'').

Filing Dates: The application was filed on August 22, 2014, and amended
on January 9, 2015, and June 26, 2015.

Hearing or Notification of Hearing: An order granting the requested
relief will be issued unless the Commission orders a hearing.
Interested persons may request a hearing by writing to the Commission's
Secretary and serving applicants with a copy of the request, personally
or by mail. Hearing requests should be received by the Commission by
5:30 p.m. on September 8, 2015, 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
Street NE., Washington, DC 20549-1090; Applicants, 201 East Fifth
Street, Suite 1600, Cincinnati, OH 45202.

FOR FURTHER INFORMATION CONTACT:  Christine Y. Greenlees, Senior
Counsel, at<PHONE_NUMBER> or David P. Bartels, Branch Chief, at (202)
551-6821 (Division of Investment Management, Chief Counsel's Office).

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. The Fund and the Master Fund are non-diversified closed-end
management investment companies registered under the Act and organized
as Delaware limited liability companies.\1\ The Adviser, a Delaware
limited liability company, is registered with the Commission as an
investment adviser under the Investment Advisers Act of 1940 and serves
as investment adviser to the Master Fund. Foreside Fund Services, LLC,
a registered broker-dealer under the Securities Exchange Act of 1934
(``1934 Act''), currently acts as Distributor (as defined below) for
the Units \2\ of the Fund. Any future placement agent or distributor/
principal underwriter of the Fund (the ``Distributor'') will be
unaffiliated with the Adviser.
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    \1\ The Fund currently serves as the sole feeder fund in a
master-feeder structure operating in accordance with section
12(d)(1)(E) of the Act and invests substantially all of its assets
in the Master Fund through a Cayman Islands limited duration company
(the ``Offshore Fund''). Applicants state that, consistent with
section 12(d)(1)(E) of the 1940 Act, the Fund holds no investment
security other than the securities of the Master Fund. If the
requested relief is granted, the Offshore Fund will be dissolved and
the Fund will invest directly in the Master Fund in compliance with
section 12(d)(1)(E) of the 1940 Act.
    \2\ ``Units'' includes any other equivalent designation of a
proportionate ownership interest of the Fund (or any other
registered closed-end management investment company relying on the
requested order).
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    2. The Fund continuously offers Units in private placements in
reliance on the provisions of Regulation D under the Securities Act of
1933, as amended (``Securities Act'').\3\ Concurrent with this
application for exemptive relief, the Fund is planning to publicly
offer its Units. Units of the Fund will not be listed on any national
securities exchange and do not trade on an over-the-counter system such
as NASDAQ. Applicants do not currently expect that a substantial and
regular secondary market for the Units will develop.
---------------------------------------------------------------------------

    \3\ Units of the Fund are only sold to ``accredited investors,''
as defined in Regulation D under the Securities Act.
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    3. The Fund currently issues a single class of Units (the ``Initial
Class'') at net asset value per Unit. The Initial Class is not
currently subject to any distribution and/or service fees. Units that
are not subject to a sales load or distribution and/or service fees
when purchased will not subsequently be subject to a sales load or
distribution and/or service fees. Investors who subscribe for Units and
are admitted to the Fund become members (``Members'') of the Fund. If
the requested relief is granted, the Fund intends to redesignate its
Initial Class as ``Class I.'' Additionally, if the requested relief is
granted, the Fund currently intends to continuously offer at least two
additional classes of Units, ``Class II'' and ``Class III,'' with each
class having its own fee and expense structure. For Class III Units,
sales of the Units will be subject to a front-end sales load based on
the offering price of the Units (i.e., net asset value) for the
Distributor's services in conjunction with the sale of Units and/or the
services provided to Members (the ``Distribution Fee''). Any waiver of,
scheduled variation in, or elimination of a Distribution Fee will
comply with the requirements of rule 22d-1 under the Act as if that
rule applied to closed-end management investment companies. Each class
may (but would not necessarily) be subject to asset-based distribution
and/or service fees. Each

class would be subject to minimum purchase requirements.
    4. In order to provide a limited degree of liquidity to Members,
the Fund may from time to time offer to repurchase Units at their then
current net asset value pursuant to rule 13e-4 under the 1934 Act
pursuant to written tenders by Members.\4\ Repurchases will be made at
such times, in such amounts and on such terms as may be determined by
the Fund's board of directors (``Board''), in its sole discretion.\5\
The Adviser expects to ordinarily recommend that the Board authorize
the Fund to offer to repurchase Units from Members semi-annually with
June 30 and December 31 valuation dates.
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    \4\ Likewise, the Master Fund's repurchase offers will be
conducted pursuant to rule 13e-4 under the 1934 Act.
    \5\ Units will be subject to an early repurchase fee at a rate
of 2% of the aggregate net asset value of the Member's Units
repurchased by the Fund (the ``Early Repurchase Fee'') if the
interval between the date of purchase of the Units and the valuation
date with respect to the repurchase of those Units is less than
eighteen months. The Early Repurchase Fee will apply equally to all
classes of Units of the Fund, consistent with section 18 of the Act
and rule 18f-3 under the Act. To the extent the Fund determines to
waive, impose scheduled variations of, or eliminate the Early
Repurchase Fee, it will do so consistently with the requirements of
rule 22d-1 under the Act and the Fund's waiver of, scheduled
variation in, or elimination of, the Early Repurchase Fee will apply
uniformly to all classes of shares of the Fund.
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    5. Applicants request that the order also apply to any other
continuously offered registered closed-end management investment
company existing now or in the future for which the Adviser or any
entity controlling, controlled by, or under common control with the
Adviser acts as investment adviser, and which provides periodic
liquidity with respect to its Units pursuant to rule 13e-4 under the
1934 Act.\6\
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    \6\ Any Fund relying on this relief will do so in a manner
consistent with the terms and conditions of the application.
Applicants represent that each investment company presently
intending to rely on the order requested in the application is
listed as an applicant.
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    6. Applicants represent that any asset-based service and/or
distribution fees will comply with the provisions of rule 2830(d) of
the Conduct Rules of the National Association of Securities Dealers,
Inc. (``NASD Conduct Rule 2830'').\7\ Applicants also represent that
the Fund will disclose in its prospectus the fees, expenses and other
characteristics of each class of Units offered for sale by the
prospectus as is required for open-end multiple class funds under Form
N-1A. The Fund will disclose fund expenses borne by Members as if it
were an open-end management investment company during the reporting
period in Member reports and describe in its prospectus any
arrangements that result in breakpoints in, or elimination of, sales
loads with respect to each class of Units offered for sale by that
prospectus.\8\ The Fund will also comply with any requirements that may
be adopted by the Commission or FINRA regarding disclosure at the point
of sale and in transaction confirmations about the costs and conflicts
of interest arising out of the distribution of open-end investment
company shares, and regarding prospectus disclosure of sales loads and
revenue sharing arrangements as if those requirements applied to the
Fund.\9\ In addition, applicants will comply with applicable enhanced
fee disclosure requirements for fund of funds, including registered
funds of hedge funds.\10\
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    \7\ All references to NASD Conduct Rule 2830 include any
successor or replacement rule that may be adopted by the Financial
Industry Regulatory Authority (``FINRA'').
    \8\ See Shareholder Reports and Quarterly Portfolio Disclosure
of Registered Management Investment Companies, Investment Company
Act Release No. 26372 (Feb. 27, 2004) (adopting release) (requiring
open-end investment companies to disclose fund expenses in
shareholder reports); and Disclosure of Breakpoint Discounts by
Mutual Funds, Investment Company Act Release No. 26464 (June 7,
2004) (adopting release) (requiring open-end investment companies to
provide prospectus disclosure of certain sales load information).
    \9\ See Confirmation Requirements and Point of Sale Disclosure
Requirements for Transactions in Certain Mutual Funds and Other
Securities, and Other Confirmation Requirement Amendments, and
Amendments to the Registration Form for Mutual Funds, Investment
Company Act Release No. 26341 (Jan. 29, 2004) (proposing release).
    \10\ Fund of Funds Investments, Investment Company Act Rel. Nos.
26198 (Oct. 1, 2003) (proposing release) and 27399 (Jun. 20, 2006)
(adopting release). See also Rules 12d1-1, et seq. of the Act.
---------------------------------------------------------------------------

    7. The Fund will allocate all expenses incurred by it among the
various classes of Units based on the net assets of the Fund
attributable to each class, except that the net asset value and
expenses of each class will reflect distribution fees, service fees,
and any other incremental expenses of that class. Expenses of a Fund
allocated to a particular class of Units will be borne on a pro rata
basis by each outstanding Unit of that class. Applicants state that the
Fund will comply with the provisions of rule 18f-3 under the Act as if
it were an open-end investment company.
    8. Although the Fund does not currently intend to impose CDSCs, the
Fund will only impose a CDSC in compliance with rule 6c-10 as if that
rule applied to closed-end management investment companies. Applicants
further state that, in the event it imposes CDSCs, the Fund will apply
the CDSCs (and any waivers or scheduled variations of the CDSCs)
uniformly to all Members of a given class and consistently with the
requirements of rule 22d-1 under the Act.

Applicants' Legal Analysis

Multiple Classes of Shares

    1. Section 18(c) of the Act provides, in relevant part, that a
closed-end investment company may not issue or sell any senior security
if, immediately thereafter, the company has outstanding more than one
class of senior security. Applicants state that the creation of
multiple classes of Units of the Fund may be prohibited by section
18(c).
    2. Section 18(i) of the Act provides that each share of stock
issued by a registered management investment company will be a voting
stock and have equal voting rights with every other outstanding voting
stock. Applicants state that permitting multiple classes of Units of
the Fund may violate section 18(i) of the Act because each class would
be entitled to exclusive voting rights with respect to matters solely
related to that class.
    3. Section 6(c) of the Act provides that the Commission may exempt
any person, security or transaction or any class or classes of persons,
securities or transactions from any provision of the Act, or from any
rule under the Act, if and to the extent such exemption is necessary or
appropriate in the public interest and consistent with the protection
of investors and the purposes fairly intended by the policy and
provisions of the Act. Applicants request an exemption under section
6(c) from sections 18(c) and 18(i) to permit the Fund to issue multiple
classes of Units.
    4. Applicants believe that the proposed allocation of expenses
relating to distribution and voting rights is equitable and will not
discriminate against any group or class of Members. Applicants submit
that the proposed arrangements would permit the Fund to facilitate the
distribution of its Units and provide investors with a broader choice
of Member options. Applicants assert that the proposed closed-end
investment company multiple class structure does not raise the concerns
underlying section 18 of the Act to any greater degree than open-end
investment companies' multiple class structures that are permitted by
rule 18f-3 under the Act. Applicants state that the Fund will comply
with the provisions of rule 18f-3 as if it were an open-end investment
company.

CDSCs
    1. Rule 6c-10 under the Act permits open-end investment companies
to impose CDSCs, subject to certain conditions. Applicants state that
although the Fund does not currently intend to impose CDSCs, the Fund
will only impose a CDSC in compliance with rule 6c-10 as if that rule
applied to closed-end management investment companies. The Fund would
also make required disclosures in accordance with the requirements of
Form N-1A concerning CDSCs as if the Fund were an open-end investment
company. Applicants further state that, in the event it imposes CDSCs,
the Fund will apply the CDSCs (and any waivers or scheduled variations
of the CDSCs) uniformly to all Members of a given class and
consistently with the requirements of rule 22d-1 under the Act.

Early Repurchase Fees

    1. To the extent the Fund determines to waive, impose scheduled
variations of, or eliminate the Early Repurchase Fee, it will do so
consistently with the requirements of Rule 22d-1 under the Act and the
Fund's waiver of, scheduled variation in, or elimination of, the Early
Repurchase Fee will apply uniformly to all classes of Units of the
Fund.

Asset-Based Service and/or Distribution Fees

    1. Section 17(d) of the Act and rule 17d-1 under the Act prohibit
an affiliated person of a registered investment company or an
affiliated person of such person, acting as principal, from
participating in or effecting any transaction in connection with any
joint enterprise or joint arrangement in which the investment company
participates unless the Commission issues an order permitting the
transaction. In reviewing applications submitted under section 17(d)
and rule 17d-1, the Commission considers whether the participation of
the investment company in a joint enterprise or joint arrangement is
consistent with the provisions, policies and purposes of the Act, and
the extent to which the participation is on a basis different from or
less advantageous than that of other participants.
    2. Rule 17d-3 under the Act provides an exemption from section
17(d) and rule 17d-1 to permit open-end investment companies to enter
into distribution arrangements pursuant to rule 12b-1 under the Act.
Applicants request an order under section 17(d) and rule 17d-1 under
the Act to permit the Fund to impose asset-based service and/or
distribution fees. Applicants have agreed to comply with rules 12b-1
and 17d-3 as if those rules applied to closed-end investment companies.
    For the reasons stated above, applicants submit that the exemptions
requested under section 6(c) are necessary and appropriate in the
public interest and are consistent with the protection of investors and
the purposes fairly intended by the policy and provisions of the Act.
Applicants also believe that the requested relief meets the standards
for relief in section 17(d) of the Act and rule 17d-1 thereunder.

Applicants' Condition

    Applicants agree that any order granting the requested relief will
be subject to the following condition:
    Each Fund relying on the order will comply with the provisions of
rules 6c-10, 12b-1, 17d-3, 18f-3 and 22d-1 under the Act, as amended
from time to time or replaced, as if those rules applied to closed-end
management investment companies, and will comply with the NASD Conduct
Rule 2830, as amended from time to time, as if that rule applied to all
closed-end management investment companies.

    For the Commission, by the Division of Investment Management,
under delegated authority.
Brent J. Fields,
Secretary.
[FR Doc. 2015-20410 Filed 8-18-15; 8:45 am]
 BILLING CODE 8011-01-P