[Federal Register Volume 76, Number 100 (Tuesday, May 24, 2011)]
[Rules and Regulations]
[Pages 29998-30001]
[FR Doc No: 2011-12803]

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DEPARTMENT OF COMMERCE

Bureau of Industry and Security

15 CFR Part 744

[Docket No. 110502271-1278-01]
RIN 0694-AF24

Removal and Modifications for Persons Listed Under Russia on the
Entity List

AGENCY: Bureau of Industry and Security, Commerce.

ACTION: Final rule.

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SUMMARY: This final rule amends the Export Administration Regulations
(EAR) by removing one and revising two Russian entries on the Entity
List (Supplement No. 4 to Part 744). This final rule removes the
Federal Atomic Power of Russia (Rusatom) (now known as the Russian
State Corporation of Atomic Energy (Rosatom)) entry from the Entity
List and adds language clarifying that both the All-Russian Scientific
Research Institute of Technical Physics (VNIITF) and the All-Russian
Scientific Research Institute of Experimental Physics (VNIIEF), which
are Rosatom components, remain on the Entity List. In addition, this
rule adds additional aliases and revises some of the existing aliases
for the two Russian entries that are being retained on the Entity List.
These changes will better inform exporters, reexporters, and
transferors of the scope of these Entity List-based license
requirements.
    The Entity List provides notice to the public that certain exports,
reexports, and transfers (in-country) to parties identified on the
Entity List require a license from the Bureau of Industry and Security
(BIS) and that availability of license exceptions in such transactions
is limited.

DATES: Effective Date: This rule is effective May 24, 2011.

FOR FURTHER INFORMATION CONTACT: Karen Nies-Vogel, Chair, End-User
Review Committee, Office of the Assistant Secretary, Export
Administration, Bureau of Industry and Security, Department of
Commerce, Phone:<PHONE_NUMBER>, Fax:<PHONE_NUMBER>, E-mail:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Background

    The Entity List provides notice to the public that certain exports,
reexports, and transfers (in-country) to entities identified on the
Entity List require a license from the Bureau of Industry and Security
(BIS) and that the availability of license exceptions in such
transactions is limited. Entities are placed on the Entity List on the
basis of certain sections of part 744 (Control Policy: End-User and
End-Use Based) of the EAR.
    The End-User Review Committee (ERC), composed of representatives of
the Departments of Commerce (Chair), State, Defense, Energy and, when
appropriate, the Treasury, makes all decisions to make additions to,
removals from and other changes to the Entity List. The ERC makes all
decisions to add an entry to the Entity List by majority vote and all
decisions to remove or modify an entry by unanimous vote. The
Departments represented on the ERC approved these changes to the Entity
List.

Entity List Decisions

    In recognition of the bilateral partnership between the United
States and Russia, a policy decision was made by the Departments
represented on the ERC to clarify the Russian entries on the Entity
List by removing one and revising two Russian entities listed on the
Entity List. The decision implemented by this final rule includes
removing the Federal Atomic Power of Russia (Rusatom) (which is now
known as the Russian State Corporation of Atomic Energy (Rosatom)) as
an individual entry on the Entity List and adding language to clarify
that two specified Russian entries (i.e., the All-Russian Scientific
Research Institute of Technical Physics (VNIITF) and the All-Russian
Scientific Research Institute of Experimental Physics (VNIIEF)) which
are Rosatom components, are both remaining on the Entity List. These
revisions further clarify that VNIITF and VNIIEF are the only Rosatom
components remaining on the Entity List. This language is being added
to clarify that neither Rosatom at locations outside of Snezhinsk and
Sarov nor any of its components or subsidiaries located outside of
Snezhinsk and Sarov are subject to the Entity List's supplemental
licensing requirements and policies.
    In addition, this rule adds other aliases and revises some of the
existing aliases for the two Russian entries that are being retained on
the Entity List. These changes will better inform exporters,
reexporters, and transferors of the scope of these Entity List-based
license requirements.

A. Removal From the Entity List

    This rule implements a policy decision made by the Departments
represented on the ERC to remove one Russian entity from the Entity
List. Specifically, this rule removes the Federal Atomic Power of
Russia (Rusatom), which is now known as the Russian State Corporation
of Atomic Energy (Rosatom) from the Entity List. However, VNIITF and
VNIIEF will remain on the Entity List. Moreover, this rule adds and
revises particular aliases of VNIITF and VNIIEF to the Entity List to
better assist exporters, reexporters and transferors in identifying
these two entities on the Entity List.
    This rule removes the following person located in Russia from the
Entity List:

Russia
    (1) Federal Atomic Power of Russia (Rusatom) (any entities,
institutes, or centers associated with), a.k.a. the following three
aliases:

--Federal Atomic Agency (FAAE);
--MINATOM; and
--Ministry of Atomic Power and Industry (MAPI).
Located in either Snezhinsk or Kremlev (Sarov).

    The removal of this entity from the Entity List eliminates the
existing license requirements in Supplement No. 4 to part 744 for
exports, reexports and transfers (in-country) to this entity, although
those licensing requirements remain in place for VNIITF and VNIIEF.
Moreover, the removal of this entity from the Entity List does not
relieve persons of other obligations under part 744 of the EAR or under
other parts of the EAR. Neither the removal of an entity from the
Entity List nor the removal of Entity List-based license requirements
relieves persons of their obligations under General Prohibition 5 in
section 736.2(b)(5) of the EAR which provides that, ``you may not,
without a license, knowingly export or reexport any item subject to the
EAR to an end-user or end-use that is prohibited by part 744 of the
EAR.'' Nor do these removals relieve persons of their obligation to
apply for export, reexport or in-country transfer licenses required by
other provisions of the EAR. BIS strongly urges the use of Supplement
No. 3 to part 732 of the EAR, ``BIS's `Know Your Customer' Guidance and
Red Flags,'' when persons are involved in transactions that are subject
to the EAR.

B. Modifications to the Entity List

    As noted above, this rule is removing the Russian entity Rusatom,
which is now known as Rosatom, from the Entity List. However, and also
as noted above, because Rosatom has components (VNIITF and VNIIEF)
located in Snezhinsk and Sarov that will remain on the Entity List,
this final rule specifies that VNIITF and VNIIEF will remain on the
Entity List.
    In addition, the changes in the final rule include adding
additional aliases and revising some of the existing aliases for VNIITF
and VNIIEF to better assist exporters, reexporters and transferors in
identifying these two entities on the Entity List. Specifically, this
rule revises the following two persons on the Entity List:

    Note:  The asterisks below indicate where revisions are being
made to these two Russian entries on the Entity List.

Russia
    (1) *All-Russian Scientific Research Institute of Technical Physics
(VNIITF), a.k.a., the following eight aliases:

*--Vserossiyskiy Nauchno-Issledovatelskiy Institut Tekhnicheskoy
Fiziki;
*--Russian Federal Nuclear Center-VNIITF (RFNC-VNIITF);
*--Kasli Nuclear Weapons Development Center;
*--Institute of Technical Physics;
*--Zababakhin Institute;
*--ARITP (All Russian Institute for Technical Physics);
--Federal State Unitary Enterprise Russian Federal Nuclear Center--
Academician E.I. Zababkhin All-Russian Scientific Research Institute of
Technical Physics (FGUPRFYaTs-VNIITF)
--Chelyabinsk--70,
(Address: P.O. Box 245, 456770, Snezhinsk, Chelyabinsk Region Russia);
and
*Any nuclear-related entities, institutes or centers located in
Snezhinsk.

    (2) *All-Russian Scientific Research Institute of Experimental
Physics (VNIIEF), a.k.a., the following nine aliases:
*--Vserossiyskiy Nauchno-Issledovatelskiy Institut Eksperimentalnoy
Fiziki;
*--Russian Federal Nuclear Center-VNIIEF (RFNC-VNIIEF);
*--Institute of Experimental Physics;
*--ARIEP (All Russian Institute for Experimental Physics);
--Khariton Institute;
--Sarov Nuclear Weapons Plant;
--Avangard Electromechanical Plant;
--Federal State Unitary Enterprise Russian Federal Nuclear Center--All
Russian Scientific Research Institute of Experimental Physics
(FGUPRFNCs VNIIEF)
--Arzamas--16,
(Address: 37 Mira Ave. Sarov, Nizhny Novgorod Region, 607188 Russia);
and
* Any nuclear-related entities, institutes or centers located in Sarov
(Kremlev).

    A BIS license is required for the export, reexport or transfer (in-
country) of any item subject to the EAR to the persons described above,
including any transaction in which this listed entity will act as
purchaser, intermediate consignee, ultimate consignee, or end-user of
the items. This listing of these entities also prohibits the use of
license exceptions (see part 740 of the EAR) for exports, reexports and
transfers (in-country) of items subject to the EAR involving this
entity.
    Although the Export Administration Act expired on August 20, 2001,
the President, through Executive Order 13222 of August 17, 2001, 3 CFR,
2001 Comp., p. 783 (2002), as extended by the Notice of August 12,
2010, 75 FR 50681 (August 16, 2010), has continued the Export
Administration Regulations in effect under the International Emergency
Economic Powers Act.

Rulemaking Requirements

    1. Executive Orders 13563 and 12866 direct agencies to assess all
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, distributive impacts, and equity). Executive
Order 13563 emphasizes the importance of quantifying both costs and
benefits, of reducing costs, of harmonizing rules, and of promoting
flexibility. This rule has been designated a ``significant regulatory
action'' although not economically significant, under section 3(f) of
Executive Order 12866. Accordingly, the rule has been reviewed by the
Office of Management and Budget.
    2. Notwithstanding any other provision of law, no person is
required to respond to nor be subject to a penalty for failure to
comply with a collection of information, subject to the requirements of
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.) (PRA),
unless that collection of information displays a currently valid Office
of Management and Budget (OMB) Control Number. This regulation involves
collections previously approved by the OMB under control numbers 0694-
0088, ``Multi-Purpose Application,'' which carries a burden hour
estimate of 58 minutes to prepare and submit form BIS-748.
Miscellaneous and recordkeeping activities account for 12 minutes per
submission. Total burden hours associated with the Paperwork Reduction
Act and Office and Management and Budget control number 0694-0088 are
not expected to increase as a result of this rule. You may send
comments regarding the collection of information associated with this
rule, including suggestions for reducing the burden, to Jasmeet K.
Seehra, Office of Management and Budget (OMB), by e-mail to Jasmeet--
K.--Seehra@omb. eop.gov, or by fax to<PHONE_NUMBER>.
    3. This rule does not contain policies with Federalism implications
as that term is defined in Executive Order 13132.
    4. The provisions of the Administrative Procedure Act (5 U.S.C.
553) requiring notice of proposed

rulemaking, the opportunity for public comment and a delay in effective
date are inapplicable because this regulation involves a military or
foreign affairs function of the United States. (See 5 U.S.C.
553(a)(1)). The U.S. Government's original basis for adding the
entities affected by this rule to the Entity List was the entities'
involvement in activities contrary to U.S. national security or foreign
policy interests. BIS implements this rule to further protect U.S.
national security and foreign policy interests by preventing items from
being exported, reexported or transferred (in-country) to these persons
listed on the Entity List by making clarifications to the existing
entries to inform exporters, reexporters and persons making transfers
(in-country) of the intended scope of the license requirements for
these listed persons. This action does this by clarifying the listings
of VNIITF and VNIIEF, clarifying the names of existing aliases, and
adding aliases for the listed persons. If this rule were delayed to
allow for notice and comment and a delay in effective date, there is a
chance that certain exporters, reexporters and persons making transfers
(in-country) to these listed persons may inadvertently export, reexport
or transfer (in-country) to a listed person on the Entity List because
the exporter, reexporter or person making the transfer (in-country) did
not realize the listed person was subject to the Entity List-based
license requirement because of perceived ambiguity regarding the listed
person, such as a perceived ambiguity resulting from the use of an
alias by a listed person. There is also a chance an exporter,
reexporter or person making a transfer (in-country) may turn away a
potential export, reexport, or transfer (in-country) because the
customer incorrectly appeared to be within the scope of a listed person
on the Entity List, thereby harming U.S. economic interests. The
clarification of language provided in this rule may make clear that the
person was not subject to an Entity List-based license requirement. For
these reasons there is a public interest that these changes be
implemented as a final action. Further, no other law requires that a
notice of proposed rulemaking and an opportunity for public comment be
given for this rule. Because a notice of proposed rulemaking and an
opportunity for public comment are not required to be given for this
rule by 5 U.S.C. 553, or by any other law, the analytical requirements
of the Regulatory Flexibility Act, 5 U.S.C. 601 et seq., are not
applicable.

List of Subjects in 15 CFR Part 744

    Exports, Reporting and recordkeeping requirements, Terrorism.

    Accordingly, part 744 of the Export Administration Regulations (15
CFR parts 730-774) is amended as follows:

PART 744--[AMENDED]

0
1. The authority citation for 15 CFR part 744 continues to read as
follows:

    Authority:  50 U.S.C. app. 2401 et seq.; 50 U.S.C. 1701 et seq.;
22 U.S.C. 3201 et seq.; 42 U.S.C. 2139a; 22 U.S.C. 7201 et seq.; 22
U.S.C. 7210; E.O. 12058, 43 FR 20947, 3 CFR, 1978 Comp., p. 179;
E.O. 12851, 58 FR 33181, 3 CFR, 1993 Comp., p. 608; E.O. 12938, 59
FR 59099, 3 CFR, 1994 Comp., p. 950; E.O. 12947, 60 FR 5079, 3 CFR,
1995 Comp., p. 356; E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp., p.
228; E.O. 13099, 63 FR 45167, 3 CFR, 1998 Comp., p. 208; E.O. 13222,
66 FR 44025, 3 CFR, 2001 Comp., p. 783; E.O. 13224, 66 FR 49079, 3
CFR, 2001 Comp., p. 786; Notice of August 12, 2010, 75 FR 50681
(August 16, 2010); Notice of November 4, 2010, 75 FR 68673 (November
8, 2010); Notice of January 13, 2011, 76 FR 3009 (January 18, 2011).

0
2. Supplement No. 4 to part 744 is amended:
0
a. By removing under Russia, the Russian entity, Federal Atomic Power
of Russia (Rusatom); and
0
b. By revising, under Russia, the following two Russian entities: All-
Russian Scientific Research Institute of Technical Physics (VNIITF) and
All-Russian Scientific Research Institute of Experimental Physics
(VNIIEF).
    The revisions read as follows:

Supplement No. 4 to Part 744--Entity List

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                                                                                Federal Register
      Country                Entity           License  requirement  License review policy         citation
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
RUSSIA.............  All-Russian Scientific  For all items subject  Case-by-case basis...  62 FR 35334, 6/30/97
                      Research Institute of   to the EAR.                                   66 FR 24267, 5/14/01
                      Technical Physics                                                     75 FR 78883, 12/17/
                      (VNIITF), a.k.a., the                                                 10.
                      following eight
                      aliases:
                       --Vserossiyskiy                                                     ***76 FR [INSERT FR
                     Nauchno-                                                               PAGE NUMBER] 5/24/
                     Issledovatelskiy                                                       11.
                     Institut Tekhnicheskoy
                     Fiziki;
                       --Russian Federal
                     Nuclear Center-VNIITF
                     (RFNC-VNIITF);
                       --Kasli Nuclear
                     Weapons Development
                     Center;
                       --Institute of
                     Technical Physics;
                       --Zababakhin
                     Institute;
                       --ARITP (All Russian
                     Institute for
                     Technical Physics);
                       --Federal State
                     Unitary Enterprise
                     Russian Federal
                     Nuclear Center--
                     Academician E.I.
                     Zababkhin All-Russian
                     Scientific Research
                     Institute of Technical
                     Physics (FGUPRFYaTs-
                     VNIITF)
                       --Chelyabinsk-70,
                     (Address: P.O. Box
                     245, 456770,
                     Snezhinsk, Chelyabinsk
                     Region Russia); and
                     any nuclear-related
                     entities, institutes,
                     or centers located in
                     Snezhinsk.
                     All-Russian Scientific  For all items subject  Case-by-case basis...  62 FR 35334, 6/30/97
                      Research Institute of   to the EAR.                                   66 FR 24267, 5/14/01
                      Experimental Physics                                                  75 FR 78883, 12/17/
                      (VNIIEF), a.k.a., the                                                 10.
                      following nine
                      aliases:

                       --Vserossiyskiy                                                     ***76 FR [INSERT FR
                     Nauchno-                                                               PAGE NUMBER], 5/24/
                     Issledovatelskiy                                                       11.
                     Institut
                     Eksperimentalnoy
                     Fiziki;
                       --Russian Federal
                     Nuclear Center-VNIIEF
                     (RFNC-VNIIEF);
                       --Institute of
                     Experimental Physics;
                       --ARIEP (All Russian
                     Institute for
                     Experimental Physics);
                       --Khariton
                     Institute;
                       --Sarov Nuclear
                     Weapons Plant;
                       --Avangard
                     Electromechanical
                     Plant;
                       --Federal State
                     Unitary Enterprise
                     Russian Federal
                     Nuclear Center--All
                     Russian Scientific
                     Research Institute of
                     Experimental Physics
                     (FGUPRFNCs VNIIEF)
                       --Arzamas-16,
                     (Address: 37 Mira Ave.
                     Sarov, Nizhny Novgorod
                     Region, 607188
                     Russia); and any
                     nuclear-related
                     entities, institutes
                     or centers located in
                     Sarov (Kremlev)

                                                  * * * * * * *
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    Dated: May 19, 2011.
Kevin J. Wolf,
Assistant Secretary for Export Administration.
[FR Doc. 2011-12803 Filed 5-23-11; 8:45 am]
BILLING CODE 3510-33-P


appropriate conduct. Accordingly, no transition period is called for,
and therefore the Board intends that Rules 3502 and 3520, as well as
the definitions in Rule 3501, become effective 10 days after the date
that the SEC approves the rules.
    Rule 3521 is based on the SEC's existing contingent fee rule,
although it differs from that rule in certain respects. Accordingly,
the Board will not apply Rule 3521 to contingent fee arrangements that
were paid in their entirety, converted to fixed fee arrangements, or
otherwise unwound before the later of December 31, 2005, or 10 days
after the date that the SEC approves the rules. Of course, as noted
above, the Commission's Rule 2-01 on auditor independence treats an
auditor as not independent if it enters into a contingent fee
arrangement with an audit client today.\73\
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    \73\ 17 CFR 210.2-01(c)(5).
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    Rules 3522, 3523, and 3524 establish new criteria for appropriate
conduct by registered public accounting firms and their associated
persons. The Board believes it is appropriate to allow a reasonable
period of time for such firms to prepare internal policies and
procedures, and train their employees to ensure compliance with these
new requirements. In addition, the Board understands that engagements
covered by these rules may be in progress and that firms will need to
terminate or complete these engagements in a professional manner.
Accordingly, the Board believes it is appropriate to allow transition
periods for these rules.
    The Board understands that Rule 3523 will, in practical effect,
lead to some registered firms terminating recurring engagements to
provide tax services and may require certain members of public
companies' senior management to find other tax preparers. Accordingly,
the Board has determined that it will not apply Rule 3523 to tax
services being provided pursuant to an engagement in process at the
time the SEC approves the rules, provided that such services are
completed on or before the later of June 30, 2006 or 10 days after the
date that the SEC approves the rules. As

discussed above, the Board will treat engagements as ``in process'' if
an engagement letter has been executed and work of substance has
commenced; the Board will not treat engagements as ``in process''
during negotiations on the scope and fee for a service.
    Although the Board does not expect them to require the same
transition as Rule 3523, Rules 3522 and 3524 also impose new legal
requirements. Accordingly, the Board has determined that it will not
apply Rule 3522 to tax services that were completed by a registered
public accounting firm no later than the later of December 31, 2005, or
10 days after the date that the SEC approves the rules. Rule 3524 will
not apply to any tax service pre-approved before the later of December
31, 2005, or 10 days after the date that the SEC approves the rules,
or, in the case of an issuer that pre-approves non-audit services by
policies and procedures, the rule will not apply to any tax service
provided by March 31, 2006.
The Technical Amendments
    On November 22, 2005, the Board adopted technical amendments to
Rules 3502 and 3522 and revised the effective dates for certain of the
rules. The Board described these amendments as follows:
    After discussions with the SEC staff, the Board has decided to
remove the word ``cause'' from the title and text of Rule 3502. This
amendment is intended to avoid any misperception that the rule affects
the interpretation of any provision of the federal securities laws. The
rule, as amended, should be interpreted and understood to be the same
as the rule adopted by the Board in July, however.\74\ In particular,
under the amended rule, the person's conduct must have the same
relation to the violation and the person must act with the same mental
state as under the rule the Board adopted in July.
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    \74\ See PCAOB Release No. 2005-014 (July 26, 2005), at 9-14
(discussing Rule 3502).
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    The Board is also amending Note 1 to Rule 3522(b) to correct a
typographical error in the citation of the provision of the Internal
Revenue Code cited in that note.
    In light of the time that has elapsed since their adoption, the
Board has also decided to revise the effective dates for certain of the
rules. Three of those rules `` Rules 3521, 3522 and 3524 `` had
effective dates of the later of December 31, 2005 or 10 days after the
date the SEC approves the rules.\75\ The Board has decided to revise
the effective dates of those three rules to 60 days after the date the
SEC approves the rules.\76\
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    \75\ See id., at 47-48.
    \76\ The effective dates of Rules 3501, 3502, 3520 and 3523 are
not changed by this release and remain as set forth in the Board's
adopting release. Id.
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    Specifically, the Board will not apply Rule 3521 to contingent fee
arrangements that were paid in their entirety, converted to fixed fee
arrangements, or otherwise unwound before 60 days after the date that
the SEC approves the rules.\77\ The Board will not apply Rule 3522 to
tax services that were completed by a registered public accounting firm
no later than 60 days after the date that the SEC approves the rules.
Rule 3524 will not apply to any tax service pre-approved before 60 days
after the date that the SEC approves the rules, or, in the case of an
issuer that pre-approves non-audit services by policies and procedures,
the rule will not apply to any tax service provided by March 31, 2006.
Combined with the time period since the rules' adoption, the extension
of the effective dates for these rules should allow reasonable time for
affected firms to prepare internal policies and procedures, train their
employees to ensure compliance with the new requirements, and, if
necessary, terminate or complete any ongoing engagements covered by the
rules in a professional manner.
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    \77\ Of course, the Commission's Rule 2-01 on auditor
independence treats an auditor as not independent if it enters into
a contingent fee arrangement with an audit client today. 17 CFR
210.2-01(c)(5).
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III. Date of Effectiveness of the Proposed Rule and Timing for
Commission Action

    Within 35 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the Board consents, the Commission will:
    (a) By order approve such proposed rule; or
    (b) Institute proceedings to determine whether the proposed rule
should be disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views and
arguments concerning the foregoing, including whether the proposed
rules are consistent with the requirements of Title I of the Act. The
Commission also requests specific comment on the following:
    Regarding proposed Rule 3522, the Board indicates that while an
auditor's independence is not impaired per se upon a subsequent listing
of a transaction under the regulations of the Department of Treasury or
the Internal Revenue Service, ``firms should nevertheless be cautious
in participating in transactions that they believe could become
listed.'' The Board further states that, if a transaction later becomes
listed, the auditor ``should carefully consider the potential
impairment of its independence with the audit committee of its
client.'' For example, the Board states that the ``auditor's judgment
regarding appropriate financial reporting and disclosure concerning a
transaction that becomes listed could become biased by the auditor's
vested interests in defending its tax advice.'' The Board also declined
to adopt a bright-line rule providing that, so long as a transaction
recommended by the firm was not listed at the time it was executed,
subsequent listing could not impair an auditor's independence at the
later date. Instead, the Board notes that the requirement for the
auditor to consider, on a forward-looking basis, whether such a
situation may reasonably be thought to bear on its independence is
addressed in existing independence requirements. As such, the Board
determined not to expand proposed Rule 3522(b) to specifically address
this issue. We request comment on this discussion. Is it clear from the
Board's discussion that a subsequent listing of a transaction, while
not in and of itself impairing the auditor's independence prior to the
listing of the transaction, may impact independence from the date of
the listing forward? Is additional guidance necessary regarding the
consideration of an auditor's independence when a transaction planned
or opined on by the auditor subsequently becomes listed?
    Comments may be submitted by any of the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/pcaob.shtml.
); or     Send an e-mail to<EMAIL_ADDRESS>Please include

File Number PCAOB-2006-01 on the subject line.

Paper Comments

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

All submissions should refer to File No. PCAOB-2006-01. 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). Copies of the

submission, all subsequent amendments, all written statements with
respect to the proposed rule 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 Section, 100 F Street, NE., Washington, DC 20549-1090. Copies
of such filing also will be available for inspection and copying at the
principal office of PCAOB. All comments received will be posted without
change; we do not edit personal identifying information from
submissions. You should submit only information that you wish to make
available publicly. All submissions should be submitted on or before
April 3, 2006.

    By the Commission.
Nancy M. Morris,
Secretary.
[FR Doc. 06-2365 Filed 3-10-06; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 80, Number 226 (Tuesday, November 24, 2015)]
[Proposed Rules]
[Pages 73147-73148]
[FR Doc No: 2015-29748]

========================================================================
Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.

========================================================================

Federal Register / Vol. 80, No. 226 / Tuesday, November 24, 2015 /
Proposed Rules

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2015-4070; Directorate Identifier 2015-NE-31-AD]
RIN 2120-AA64

Airworthiness Directives; Turbomeca S.A. Turboshaft Engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to adopt a new airworthiness directive (AD) for
certain Turbomeca S.A. Arriel 1E2 turboshaft engines. This proposed AD
was prompted by reports of uncommanded in-flight shutdowns (IFSDs).
This proposed AD would require removing the tachometer box on affected
engines. We are proposing this AD to prevent failure of the tachometer
box, which could lead to failure of the engine, IFSD, and loss of
control of the helicopter.

DATES: We must receive comments on this proposed AD by January 25,
2016.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the 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: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
     Fax:<PHONE_NUMBER>.
    For service information identified in this proposed AD, contact
Turbomeca S.A., 40220 Tarnos, France; phone: 33 (0)5 59 74 40 00; fax:
33 (0)5 59 74 45 15. You may view this service information at the FAA,
Engine & Propeller Directorate, 12 New England Executive Park,
Burlington, MA. For information on the availability of this material at
the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-
4070; or in person at the Docket Operations office between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. The AD docket
contains this proposed AD, the mandatory continuing airworthiness
information (MCAI), the regulatory evaluation, any comments received,
and other information. The address for the Docket Office (phone: 800-
647-5527) is in the ADDRESSES section. Comments will be available in
the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Philip Haberlen, Aerospace Engineer,
Engine Certification Office, FAA, Engine & Propeller Directorate, 12
New England Executive Park, Burlington, MA 01803; phone:<PHONE_NUMBER>;
fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2015-4070;
Directorate Identifier 2015-NE-31-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this NPRM. We will
consider all comments received by the closing date and may amend this
NPRM based on 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
with FAA personnel concerning this NPRM.

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Community, has issued EASA
AD 2015-0175, dated August 24, 2015 (referred to hereinafter as ``the
MCAI''), to correct an unsafe condition for the specified products. The
MCAI states:

    There have been reports of Arriel 1E2 engines having experienced
an uncommanded in-flight shut-down (IFSD) due to an untimely
activation of the tachometer box shut-off system which was activated
by the power turbine monitoring function of the tachometer box.
    This condition, if not corrected, could potentially lead to
further cases of IFSD, possibly resulting in a forced landing.

    You may obtain further information by examining the MCAI in the AD
docket on the Internet at http://www.regulations.gov by searching for
and locating Docket No. FAA-2015-4070.

Related Service Information

    Turbomeca S.A. has issued Mandatory Service Bulletin No. 292 77
0844, Version B, dated July 6, 2015. The service information describes
procedures for removing pre-TU 369 tachometer boxes. This service
information is reasonably available because the interested parties have
access to it through their normal course of business or by the means
identified in the ADDRESSES section of this NPRM.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of France,
and is approved for operation in the United States. Pursuant to our
bilateral agreement with the European Community, EASA has notified us
of the unsafe condition described in the MCAI and service information
referenced above. We are proposing this AD because we evaluated all
information provided by EASA and determined the unsafe condition exists
and is likely to exist or develop on other products of the same type
design. This NPRM would require removing the pre-TU 369 tachometer box
from the engine.

Costs of Compliance

    We estimate that this proposed AD affects 200 engines installed on
helicopters of U.S. registry. We also estimate that it would take about
3 hours per engine to comply with this proposed AD. The average labor
rate is $85 per hour. Based on these figures, we estimate the cost of
this proposed AD on U.S. operators to be $51,000.

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.

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would 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 this proposed
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.

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 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 adding the following new airworthiness
directive (AD):

Turbomeca S.A.: Docket No. FAA-2015-4070; Directorate Identifier
2015-NE-31-AD.

(a) Comments Due Date

    We must receive comments by January 25, 2016.

(b) Affected ADs

    None.

(c) Applicability

    (1) This AD applies to Turbomeca S.A. Arriel 1E2 turboshaft
engines with tachometer boxes with the following part number (P/N)
and serial number (S/N) combinations:
    (i) P/N<PHONE_NUMBER>--all S/Ns
    (ii) P/N<PHONE_NUMBER>--all S/Ns
    (iii) P/N<PHONE_NUMBER>--all S/Ns
    (iv) P/N<PHONE_NUMBER>--all S/Ns
    (v) P/N<PHONE_NUMBER>--all S/Ns 1499 and below with or without
suffix letters and all S/Ns 1500 and above that do not contain the
suffix letters EL.
    (2) This AD applies only to Turbomeca S.A. Arriel 1E2 turboshaft
engines with tachometer boxes identified in paragraph (c)(1) of this
AD that also have installed electrical connectors labeled as P10106,
P10098, and P10108 or P11F, P13F, and P15F.

(d) Reason

    This AD was prompted by reports of uncommanded in-flight
shutdowns (IFSDs). We are issuing this AD to prevent failure of the
tachometer box, which could lead to failure of the engine, IFSD, and
loss of control of the helicopter.

(e) Actions and Compliance

    Comply with this AD within the compliance times specified,
unless already done.
    (1) Within 1,600 flight hours after the effective date of this
AD, remove the affected tachometer box from the engine.
    (2) Reserved.

(f) Credit for Previous Action

    You may take credit for the action required by paragraph (e) of
this AD if you performed the action before the effective date of
this AD in accordance with Turbomeca S.A. MSB 292 77 0844, Version
A, dated March 4, 2015 or earlier version.

(g) Alternative Methods of Compliance (AMOCs)

    The Manager, Engine Certification Office, FAA, may approve AMOCs
for this AD. Use the procedures found in 14 CFR 39.19 to make your
request. You may email your request to<EMAIL_ADDRESS>
(h) Related Information

    (1) For more information about this AD, contact Philip Haberlen,
Aerospace Engineer, Engine Certification Office, FAA, Engine &
Propeller Directorate, 12 New England Executive Park, Burlington, MA
01803; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>    (2) Refer to MCAI European Aviation Safety Agency AD 2015-0175,
dated August 24, 2015, which includes Mandatory Service Bulletin No.
292 77 0844, Version B, dated July 6, 2015, for related information.
You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov by searching for and locating it in Docket No.
FAA-2015-4070.
    (3) You may view this service information at the FAA, Engine &
Propeller Directorate, 12 New England Executive Park, Burlington,
MA. For information on the availability of this material at the FAA,
call<PHONE_NUMBER>.

    Issued in Burlington, Massachusetts, on November 12, 2015.
Colleen M. D'Alessandro,
Directorate Manager, Engine & Propeller Directorate, Aircraft
Certification Service.
[FR Doc. 2015-29748 Filed 11-23-15; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 78, Number 97 (Monday, May 20, 2013)]
[Proposed Rules]
[Pages 29289-29292]
[FR Doc No: 2013-11751]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2013-0059]
RIN 1625-AA00

Safety Zone; Big Bay Boom, San Diego Bay, San Diego, CA

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed rulemaking.

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

SUMMARY: The Coast Guard proposes to establish four temporary safety
zones upon the navigable waters of San Diego

Bay for the Port of San Diego Big Bay Boom Fireworks display from 8:45
p.m. to 10 p.m. on July 4, 2013. These proposed safety zones are
necessary to provide for the safety of the crew, spectators, and other
users and vessels of the waterway. Persons and vessels are prohibited
from entering into, transiting through, or anchoring within these
temporary safety zones during, immediately before and after the
fireworks event unless authorized by the Captain of the Port or his
designated representative.

DATES: Comments and related material must be received by the Coast
Guard on or before June 19, 2013.
    Requests for public meetings must be received by the Coast Guard on
or before June 3, 2013.

ADDRESSES: You may submit comments identified by docket number using
any one of the following methods:
    (1) Federal eRulemaking Portal: http://www.regulations.gov.
    (2) Fax:<PHONE_NUMBER>.
    (3) Mail or Delivery: Docket Management Facility (M-30), U.S.
Department of Transportation, West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue SE., Washington, DC 20590-0001. Deliveries
accepted between 9 a.m. and 5 p.m., Monday through Friday, except
federal holidays. The telephone number is<PHONE_NUMBER>.
    See the ``Public Participation and Request for Comments'' portion
of the SUPPLEMENTARY INFORMATION section below for further instructions
on submitting comments. To avoid duplication, please use only one of
these three methods.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Lieutenant John Bannon, Chief of Waterways Management,
U.S. Coast Guard Sector San Diego; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>If you have questions on viewing or submitting
material to the docket, call Barbara Hairston, Program Manager, Docket
Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Table of Acronyms

DHS Department of Homeland Security
FR Federal Register
NPRM Notice of Proposed Rulemaking

A. Public Participation and Request for Comments

    We encourage you to participate in this rulemaking by submitting
comments and related materials. All comments received will be posted
without change to http://www.regulations.gov and will include any
personal information you have provided.

1. Submitting Comments

    If you submit a comment, please include the docket number for this
rulemaking, indicate the specific section of this document to which
each comment applies, and provide a reason for each suggestion or
recommendation. You may submit your comments and material online at
http://www.regulations.gov, or by fax, mail, or hand delivery, but
please use only one of these means. If you submit a comment online, it
will be considered received by the Coast Guard when you successfully
transmit the comment. If you fax, hand deliver, or mail your comment,
it will be considered as having been received by the Coast Guard when
it is received at the Docket Management Facility. We recommend that you
include your name and a mailing address, an email address, or a
telephone number in the body of your document so that we can contact
you if we have questions regarding your submission.
    To submit your comment online, go to http://www.regulations.gov,
type the docket number [USCG-2013-0059] in the ``SEARCH'' box and click
``SEARCH.'' Click on ``Submit a Comment'' on the line associated with
this rulemaking.
    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
material received during the comment period and may change the rule
based on your comments.

2. Viewing Comments and Documents

    To view comments, as well as documents mentioned in this preamble
as being available in the docket, go to http://www.regulations.gov,
type the docket number (USCG-2013-0059) in the ``SEARCH'' box and click
``SEARCH.'' Click on Open Docket Folder on the line associated with
this rulemaking. You may also visit the Docket Management Facility in
Room W12-140 on the ground floor of the Department of Transportation
West Building, 1200 New Jersey Avenue SE., Washington, DC 20590,
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays.

3. Privacy Act

    Anyone can search the electronic form of comments received into any
of our dockets by the name of the individual submitting the comment (or
signing the comment, if submitted on behalf of an association,
business, labor union, etc.). You may review a Privacy Act notice
regarding our public dockets in the January 17, 2008, issue of the
Federal Register (73 FR 3316).

4. Public Meeting

    We do not now plan to hold a public meeting. But you may submit a
request for one, using one of the methods specified under ADDRESSES.
Please explain why you believe a public meeting would be beneficial. If
we determine that one would aid this rulemaking, we will hold one at a
time and place announced by a later notice in the Federal Register.

B. Basis and Purpose

    The Ports and Waterways Safety Act gives the Coast Guard authority
to create and enforce safety zones. The Coast Guard is proposing four
temporary safety zones on the navigable waters of the San Diego Bay for
the Port of San Diego Big Bay Boom Independence Day Fireworks Display.
The safety zones will include all navigable waters within 1,000 feet of
each tug and barge. The tugs and barges will be located in the
following approximate positions:

Shelter Island Barge: 32[deg]42.8' N, 117[deg]13.2' W
Harbor Island Barge: 32[deg]43.3' N, 117[deg]12.0' W
Embarcadero Barge: 32[deg]42.9' N, 117[deg]10.8' W
Seaport Village Barge: 32[deg]42.2' N, 117[deg]10.0' W
These temporary safety zones are necessary to provide for the safety of
the fireworks barge crew and participating safety vessels, recreational
boating spectators, and other users of the waterway from hazards
associated with fireworks. Fireworks launched in close proximity to
watercraft pose a significant risk to public safety and property. Such
displays draw large numbers of spectators on vessels. The combination
of a large number of spectators, congested waterways, darkness
punctuated by bright flashes of light and burning debris has the
potential to result in serious injuries or fatalities. The proposed
safety zones will restrict vessels from operating within a portion of
the navigable waters around the fireworks launch platforms during the
enforcement period which will be immediately before, during, and
immediately after the fireworks displays.

C. Discussion of Proposed Rule

    The Coast Guard proposes to establish temporary safety zones that
would be enforced from 8:45 p.m. until 10 p.m. on July 4, 2013. These
proposed safety zones are necessary to provide for the safety of the
crews, spectators, participants, and other vessels and users of the
waterway. Persons and vessels would be prohibited from entering into,
transiting through, or anchoring within this safety zone unless
authorized by the Captain of the Port, or his designated
representative. The proposed temporary safety zones would include a
portion of waters in the San Diego Bay. Before the effective period,
the Coast Guard will publish a Coast Guard District Eleven Local Notice
to Mariners information on the event and associated safety zones.
Immediately before and during the fireworks display, Coast Guard Sector
San Diego Joint Harbor Operations Center will issues Broadcast Notice
to Mariners on the location and enforcement of the safety zones.
    Vessels will be able to transit the surrounding area and may be
authorized to transit through the proposed safety zones with the
permission of the Captain of the Port or the designated representative.
Before activating the zones, the Coast Guard will notify mariners by
appropriate means including but not limited to Local Notice to Mariners
and Broadcast Notice to Mariners.

D. Regulatory Analyses

    We developed this proposed rule after considering numerous statutes
and executive orders related to rulemaking. Below we summarize our
analyses based on a number of these statutes or executive orders.

1. Regulatory Planning and Review

    This proposed rule is not a significant regulatory action under
section 3(f) of Executive Order 12866, Regulatory Planning and Review,
as supplemented by Executive Order 13563, Improving Regulation and
Regulatory Review, and does not require an assessment of potential
costs and benefits under section 6(a)(3) of Executive Order 12866 or
under section 1 of Executive Order 13563. The Office of Management and
Budget has not reviewed it under those Orders. This determination is
based on the size, duration and location of the safety zones. The
safety zones are relatively small in size, less than half a mile
across, and short in duration, 75 minutes long. Although the safety
zones would apply to multiple parts of San Diego Bay, traffic would be
allowed to pass through the zone with the permission of the Captain of
the Port. Additionally, before the effective period, the Coast Guard
will publish a Local Notice to Mariners.

2. Impact on Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered the impact of this proposed rule on small entities. The
Coast Guard certifies under 5 U.S.C. 605(b) that this proposed rule
will not have a significant economic impact on a substantial number of
small entities. This proposed rule will affect the following entities,
some of which might be small entities: the owners or operators of
vessels intending to transit or anchor in the impacted portions of San
Diego Bay, CA from 8:45 p.m. to 10 p.m. on July 4, 2013.
    These safety zones will not have a significant economic impact on a
substantial number of small entities for the following reasons. The
safety zones are relatively small in size, less than half a mile
across, and short in duration, 75 minutes long. Although the safety
zone would apply to multiple safety zones around the bay, traffic would
be allowed to pass through the zones with the permission of the Coast
Guard patrol commander. Before the effective period, the Coast Guard
will publish a Local Notice to Mariners.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this rule would have
a significant economic impact on it, please submit a comment (see
ADDRESSES) explaining why you think it qualifies and how and to what
degree this rule would economically affect it.

3. Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this proposed rule. If the rule would affect
your small business, organization, or governmental jurisdiction and you
have questions concerning its provisions or options for compliance,
please contact the person listed in the FOR FURTHER INFORMATION
CONTACT, above. The Coast Guard will not retaliate against small
entities that question or complain about this proposed rule or any
policy or action of the Coast Guard.

4. Collection of Information

    This proposed rule will not call for a new collection of
information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520.).

5. Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has 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. We have analyzed this proposed rule under that Order and
determined that this rule does not have implications for federalism.

6. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

7. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this proposed rule would not
result in such an expenditure, we do discuss the effects of this rule
elsewhere in this preamble.

8. Taking of Private Property

    This proposed rule would not cause a taking of private property or
otherwise have taking implications under Executive Order 12630,
Governmental Actions and Interference with Constitutionally Protected
Property Rights.

9. Civil Justice Reform

    This proposed rule meets applicable standards in sections 3(a) and
3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize
litigation, eliminate ambiguity, and reduce burden.

10. Protection of Children From Environmental Health Risks

    We have analyzed this proposed rule under Executive Order 13045,
Protection of Children from Environmental Health Risks and Safety
Risks. This rule is not an economically significant rule and would not
create an environmental risk to health or risk to safety that might
disproportionately affect children.

11. Indian Tribal Governments

    This proposed rule does not have tribal implications under
Executive Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it would not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.

12. Energy Effects

    This proposed rule is not a ``significant energy action'' under
Executive Order 13211, Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use.

13. Technical Standards

    This proposed rule does not use technical standards. Therefore, we
did not consider the use of voluntary consensus standards.

14. Environment

    We have analyzed this proposed rule under Department of Homeland
Security Management Directive 023-01 and Commandant Instruction
M16475.lD, which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and
have made a preliminary determination that this action is one of a
category of actions that do not individually or cumulatively have a
significant effect on the human environment. This proposed rule
involves establishing a temporary safety zone. This rule is
categorically excluded from further review under paragraph 34(g) of
Figure 2-1 of the Commandant Instruction. A preliminary environmental
analysis checklist supporting this determination and a Categorical
Exclusion Determination are available in the docket where indicated
under ADDRESSES. We seek any comments or information that may lead to
the discovery of a significant environmental impact from this proposed
rule.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard proposes
to amend 33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority: 33 U.S.C. 1226, 1231; 46 U.S.C. Chapter 701, 3306,
3703; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5;
Pub. L. 107-295, 116 Stat. 2064; Department of Homeland Security
Delegation No. 0170.1.

0
2. Add Sec.  165.T11-563 to read as follows:

Sec.  165.T11-563  Safety zone; Big Bay Boom; San Diego, CA.

    (a) Location. This rule establishes four temporary safety zones,
encompassing all navigable waters of San Diego Bay within a 1000-foot
radius of fireworks launching points:

Shelter Island Barge: 32[deg]42.8' N, 117[deg]13.2' W
Harbor Island Barge: 32[deg]43.3' N, 117[deg]12.0' W
Embarcadero Barge: 32[deg]42.9' N, 117[deg]10.8' W
Seaport Village Barge: 32[deg]42.2' N, 117[deg]10.0' W

    (b) Enforcement period. This section will be enforced from 8:45
p.m. to 10 p.m. on July 4, 2013. Before the effective period, the Coast
Guard will publish a Local Notice to Mariners (LNM). If the event
concludes prior to the scheduled termination time, the Captain of the
Port will cease enforcement of this safety zone and will announce that
fact via Broadcast Notice to Mariners.
    (c) Definitions. The following definition applies to this section:
designated representative means any commissioned, warrant, or petty
officer of the Coast Guard on board Coast Guard, Coast Guard Auxiliary,
and local, state, and federal law enforcement vessels who have been
authorized to act on the behalf of the Captain of the Port.
    (d) Regulations. (1) Entry into, transit through or anchoring
within this safety zone is prohibited unless authorized by the Captain
of the Port of San Diego or his designated representative.
    (2) Mariners can request permission to transit through the safety
zone from the Patrol Commander. The Patrol Commander can be contacted
on VHF-FM channels 16 and 23.
    (3) All persons and vessels shall comply with the instructions of
the Coast Guard Captain of the Port or his designated representative.
    (4) Upon being hailed by U.S. Coast Guard patrol personnel by
siren, radio, flashing light, or other means, the operator of a vessel
shall proceed as directed.
    (5) The Coast Guard may be assisted by other federal, state, or
local agencies.

    Dated: May 2, 2013.
S.M. Mahoney,
Captain, U.S. Coast Guard, Captain of the Port San Diego.
[FR Doc. 2013-11751 Filed 5-17-13; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 86, Number 3 (Wednesday, January 6, 2021)]
[Notices]
[Pages 549-550]
[FR Doc No: 2020-29238]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-D-2101]

Human Gene Therapy for Neurodegenerative Diseases; Draft Guidance
for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft document entitled ``Human Gene Therapy for
Neurodegenerative Diseases; Draft Guidance for Industry.''
Neurodegenerative diseases are a heterogeneous group of disorders
characterized by progressive degeneration of the structure and function
of the central nervous system or peripheral nervous system. The draft
guidance document provides recommendations to sponsors developing a
human gene therapy (GT) product for neurodegenerative diseases
affecting adult and pediatric patients. The guidance focuses on
considerations for product development, preclinical testing, and
clinical trial design.

DATES: Submit either electronic or written comments on the draft
guidance by April 6, 2021 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-2020-D-2101 for ``Human Gene Therapy for Neurodegenerative
Diseases; Draft Guidance 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,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 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,<PHONE_NUMBER>.
    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 guidance to the
Office of Communication, Outreach and Development, Center for Biologics
Evaluation and Research (CBER), Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist the office in processing
your requests. The draft guidance may also be obtained by mail by
calling CBER at 1-800-835-4709 or<PHONE_NUMBER>. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Shruti Modi, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft document entitled
``Human Gene Therapy for Neurodegenerative Diseases; Draft Guidance for
Industry.'' Neurodegenerative diseases are a heterogeneous group of
disorders characterized by progressive degeneration of the structure
and function of the central nervous system or peripheral nervous
system. The draft guidance document provides recommendations to
sponsors developing a GT product for neurodegenerative diseases
affecting adult and pediatric patients. This guidance focuses on
considerations for product development, preclinical testing, and
clinical trial design.

    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on
recommendations for sponsors developing human GT products for
neurodegenerative disorders affecting adult and pediatric patients. It
does not establish any rights for any person and is not binding on FDA
or the public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR part 50 have been approved under OMB control
number 0910-0755; the collections of information in 21 CFR part 312
have been approved under OMB control number 0910-0014; the collections
of information in 21 CFR part 601 have been approved under OMB control
number 0910-0338; and the collections of information in the guidance
entitled ``Expedited Programs for Serious Conditions--Drugs and
Biologics'' have been approved under OMB control number 0910-0765.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances or
https://www.regulations.gov.

    Dated: December 22, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-29238 Filed 1-5-21; 8:45 am]
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[Federal Register: May 29, 2008 (Volume 73, Number 104)]
[Notices]
[Page 30961]
[DOCID:fr29my08-97]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[FEMA-1751-DR]

Arkansas; Amendment No. 9 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 Arkansas (FEMA-1751-DR), dated March 26, 2008, and
related determinations.

EFFECTIVE DATE: May 22, 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 Arkansas 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 March 26, 2008.

    Perry County for Individual Assistance (already designated for
Public Assistance.)

    Calhoun County for Public Assistance.

(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
Presidential Declared Disaster Areas; 97.049, Presidential Declared
Disaster Assistance--Disaster Housing Operations for Individuals and
Households; 97.050, Presidential 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. E8-11994 Filed 5-28-08; 8:45 am]

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