[Federal Register Volume 78, Number 20 (Wednesday, January 30, 2013)]
[Notices]
[Pages 6365-6368]
[FR Doc No: 2013-01970]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-68723; File No. SR-MIAX-2013-02]

Self-Regulatory Organizations: Miami International Securities
Exchange LLC; Notice of Filing and Order Granting Accelerated Approval
of Proposed Rule Change To Adopt MIAX Rule 319 Relating to Proxy Voting

January 24, 2013.
    Pursuant to the provisions of Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice
is hereby given that on January 16, 2013, Miami International
Securities Exchange LLC (``MIAX'' or ``Exchange'') filed with the
Securities and Exchange Commission (``Commission'') a proposed rule
change as described in Items I and II below, which Items have been
prepared by the Exchange. The Commission is publishing this notice to
solicit comments on the proposed rule change from interested persons,
and is approving the proposed rule change on an accelerated basis.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 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

    The Exchange is filing a proposal to adopt Rule 319 (Proxy Voting)
in accordance with the provisions of Section 957 of the Dodd-Frank Wall
Street Reform and Consumer Protection Act (the ``Dodd-Frank Act'').
    The text of the proposed rule change is provided in Exhibit 5. The
text of the proposed rule change is also available on the Exchange's
Web site at http://www.miaxoptions.com/filter/wotitle/rule_filing, at
MIAX's principal office, and at the Commission's Public Reference Room.

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 Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange 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 Exchange is proposing to adopt MIAX Rule 319 (Proxy Voting), in
accordance with the provisions of Section 957 of the Dodd-Frank Act, to
prohibit Members from voting uninstructed shares if the matter voted on
relates to (i) the election of a member of the board of directors of an
issuer (other than an uncontested election of a director of an
investment company registered under the Investment Company Act of 1940
(the ``Investment Company Act'')), (ii) executive compensation, or
(iii) any other significant matter, as determined by the Commission, by
rule.
    Section 957 of the Dodd-Frank Act amends Section 6(b) \3\ of the
Act to require the rules of each national securities exchange to
prohibit any member organization that is not the beneficial owner of a
security registered under Section 12 \4\ of the Act from granting a
proxy to vote the security in connection with certain stockholder
votes, unless the beneficial owner of the security has instructed the
member organization to vote the proxy in accordance with the voting
instructions of the beneficial owner. The stockholder votes covered by
Section 957 include any vote with respect to (i) the election of a
member of the board of directors of an issuer (other than an
uncontested election of a director of an investment company registered
under the Investment Company Act), (ii) executive compensation, or
(iii) any other significant matter, as determined by the Commission, by
rule.
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    \3\ 15 U.S.C. 78(f)(b).
    \4\ 15 U.S.C. 781.

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    Accordingly, in order to carry out the requirements of Section 957
of the Dodd-Frank Act, the Exchange proposes to adopt proposed MIAX
Rule 319 to prohibit any Member from giving a proxy to vote stock that
is registered in its name, unless: (i) Such Member is the beneficial
owner of such stock; (ii) pursuant to the written instructions of the
beneficial owner; or (iii) pursuant to the rules of any national
securities exchange or association of which it is a member provided
that the records of the Member clearly indicate the procedure it is
following. The Exchange is proposing to adopt these rules because other
national securities exchanges and associations do allow proxy voting
under certain limited circumstances while the current Exchange Rules
are silent on such matters. Therefore, a Member that is also a member
of another national securities exchange or association may vote the
shares held for a customer when allowed under its membership at another
national securities exchange or association, provided that the records
of the Member clearly indicate the procedure it is following.
    Notwithstanding the forgoing, a Member that is not the beneficial
owner of a security registered under Section 12 of the Act is
prohibited from granting a proxy to vote the security in connection
with a shareholder vote with respect to the election of a member of the
board of directors of an issuer (except for a vote with respect to
uncontested election of a member of the board of directors of any
investment company registered under the Investment Company Act),
executive compensation, or any other significant matter, as determined
by the Commission, by rule, unless the beneficial owner of the security
has instructed the Member to vote the proxy in accordance with the
voting instructions of the beneficial owner.
    The Exchange notes that proposed MIAX Rule 319 is identical to
International Securities Exchange (``ISE'') Rule 421; and proposed MIAX
Rule 319(a) is based on NYSE Arca, Inc. (``NYSE Arca'') Rule 9.4,
Financial Industry Regulatory Authority (``FINRA'') Rule 2251; and
proposed MIAX Rule 319(b) is based on Nasdaq Rule 2251(d).
2. Statutory Basis
    MIAX believes that its proposed rule change is consistent with
Section 6(b) of the Act \5\ in general, and furthers the objectives of
Section 6(b)(5) of the Act \6\ in particular. The Exchange believes
that proposed Rule 319(a) will provide clarity to MIAX members going
forward on whether broker discretionary voting is permitted by MIAX
members under limited circumstances when the MIAX member is also a
member of another national securities exchange that permits broker
discretionary voting.
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    \5\ 15 U.S.C. 78f(b).
    \6\ 15 U.S.C. 78f(b)(5).
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    The Exchange believes that proposed Rule 319(b) is consistent with
Section 6(b)(10) \7\ of the Act, which requires that national
securities exchanges adopt rules prohibiting members that are not
beneficial holders of a security from voting uninstructed proxies with
respect to the election of a member of the board of directors of an
issuer (except for uncontested elections of directors for companies
registered under the Investment Company Act), executive compensation,
or any other significant matter, as determined by the Commission by
rule. The Exchange believes that proposed Rule 319(b) is consistent
with Section 6(b)(10) of the Act because it adopts provisions that
comply with that section.
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    \7\ 15 U.S.C. 78f(b)(10)
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    The Exchange also believes that proposed Rule 319(b) is consistent
with Section 6(b)(5) \8\ of the Act, which provides, among other
things, that the rules of the Exchange must be designed to promote just
and equitable principles of trade, remove impediments to and perfect
the mechanism of a free and open market and a national market system,
and, in general, to protect investors and the public interest, and are
not designed to permit unfair discrimination between customers,
issuers, brokers, or dealers. The Exchange is adopting this proposed
rule to comply with the requirements of Section 957 of the Dodd-Frank
Act, and therefore believes the proposed rule to be consistent with the
Exchange Act, particularly with respect to the protection of investors
and the public interest.
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    \8\ 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 not necessary or appropriate in
furtherance of the purposes of the Act. The propose (sic) rule would
allow the Exchange to implement Section 957 of the Dodd-Frank Act and
adopt rules consistent with Section 6(b)(10) of the Act, which is
applicable to all national securities exchanges and national securities
association (sic).\9\ The Exchange notes this proposed rule does not go
outside of the scope of the rules of other national securities (sic).
Additionally, consistency among the various proxy voting rules
governing national securities exchanges reduces the possibility of any
regulatory arbitrage on the part of a market participant seeking a
forum with a lower regulatory requirement.
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    \9\ The Commission notes that Section 6(b)(10) of the Act, 15
U.S.C. 78f(b)(10), does not apply to national securities
associations.
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C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    Written comments were neither solicited nor received.

III. 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 email to<EMAIL_ADDRESS>Please include
File Number SR-MIAX-2013-02 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-MIAX-2013-02. This file
number should be included on the subject line if email 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 Web site viewing and

printing in the Commission's Public Reference Room, 100 F Street, NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of the filing also will be available
for inspection and copying at the principal office of the Exchange. 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-MIAX-2013-02 and
should be submitted on or before February 20, 2013.

IV. Commission's Findings and Order Granting Accelerated Approval of
the Proposed Rule Change

    In its filing, the Exchange requested that the Commission approve
the proposal on an accelerated basis so that the Exchange could
immediately comply with the requirements imposed by the Dodd-Frank Act,
and because the proposed rule text is based upon, among others, ISE
Rule 421.\10\ After careful consideration, the Commission finds that
the proposed rule change is consistent with the requirements of the Act
and the rules and regulations thereunder applicable to a national
securities exchange.\11\
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    \10\ See Securities Exchange Act Release No. 63139 (October 20,
2010), 75 FR 65680 (October 26, 2010) (SR-ISE-2010-99).
    \11\ In approving this rule change, the Commission notes that it
has considered the proposed rule's impact on efficiency,
competition, and capital formation. See 15 U.S.C. 78c(f).
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    The Commission believes that proposed Rule 319(a) is consistent
with Section 6(b)(5) \12\ of the Act, which provides, among other
things, that the rules of the Exchange must be designed to promote just
and equitable principles of trade, remove impediments to and perfect
the mechanism of a free and open market and a national market system,
and, in general, to protect investors and the public interest, and are
not designed to permit unfair discrimination between customers,
issuers, brokers, or dealers.
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    \12\ 15 U.S.C. 78f(b)(5).
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    Under proposed Rule 319(a), a Member shall be prohibited from
voting uninstructed shares unless (1) that Member is the beneficial
owner of the stock; (2) pursuant to the written instructions of the
beneficial owner; or (3) pursuant to the rules of any national
securities exchange or association of which it is also a member,
provided that the Member's records clearly indicate the procedure it is
following. This provision is based on ISE Rule 421, which was
previously approved by the Commission.\13\ The Commission notes that
the proposed change will provide clarity to Exchange Members going
forward on whether broker discretionary voting is permitted by Exchange
Members under limited circumstances when the Member is also a member of
another national securities exchange that permits broker discretionary
voting. In approving this portion of the proposal, the Commission notes
that Rule 319(a) is consistent with the approach taken under the rules
of other national securities exchanges or national securities
association, and for Exchange Members who are not also members of
another national securities exchange prohibits broker discretionary
voting on any matter, consistent with investor protection and the
public interest under Section 6(b)(5) of the Act.\14\
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    \13\ See supra note 10.
    \14\ 15 U.S.C. 78f(b)(5).
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    The Commission believes that proposed Rule 319(b) is consistent
with Section 6(b)(10) \15\ of the Act, which requires that national
securities exchanges adopt rules prohibiting members that are not
beneficial holders of a security from voting uninstructed proxies with
respect to the election of a member of the board of directors of an
issuer (except for uncontested elections of directors for companies
registered under the Investment Company Act), executive compensation,
or any other significant matter, as determined by the Commission by
rule.
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    \15\ 15 U.S.C. 78f(b)(10).
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    The Commission believes that proposed Rule 319(b) is consistent
with Section 6(b)(10) of the Act because it adopts new language that
complies with that section. As noted in the accompanying Senate Report,
Section 957, which enacted Section 6(b)(10), reflects the principle
that ``final vote tallies should reflect the wishes of the beneficial
owners of the stock and not be affected by the wishes of the broker
that holds the shares.'' \16\ The proposed rule change will make the
Exchange compliant with the new requirements of Section 6(b)(10) by
specifically prohibiting broker-dealers, who are not beneficial owners
of a security, from voting uninstructed shares in connection with a
shareholder vote on the election of a member of the board of directors
of an issuer (except for a vote with respect to the uncontested
election of a member of the board of directors of any investment
company registered under the Investment Company Act of 1940), executive
compensation, or any other significant matter, as determined by the
Commission by rule, unless the member receives voting instructions from
the beneficial owner of the shares.\17\
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    \16\ See S. Rep. No. 111-176, at 136 (2010).
    \17\ The Commission has not, to date, adopted rules concerning
other significant matters where uninstructed broker votes should be
prohibited, although it may do so in the future. Should the
Commission adopt such rules, we would expect the Exchange to adopt
coordinating rules promptly to comply with the statute.
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    The Commission also believes that proposed Rule 319(b) is
consistent with Section 6(b)(5) \18\ of the Act, which provides, among
other things, that the rules of the Exchange must be designed to
promote just and equitable principles of trade, remove impediments to
and perfect the mechanism of a free and open market and a national
market system, and, in general, to protect investors and the public
interest, and are not designed to permit unfair discrimination between
customers, issuers, brokers, or dealers.
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    \18\ 15 U.S.C. 78f(b)(5).
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    The Commission believes that the rule assures that shareholder
votes on the election of the board of directors of an issuer (except
for a vote with respect to the uncontested election of a member of the
board of directors of any investment company registered under the
Investment Company Act of 1940) and on executive compensation matters
are made by those with an economic interest in the company, rather than
by a broker that has no such economic interest, which should enhance
corporate governance and accountability to shareholders.\19\
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    \19\ As the Commission stated in approving New York Stock
Exchange (``NYSE'') rules prohibiting broker voting in the election
of directors, having those with an economic interest in the company
vote the shares, rather than the broker who has no such economic
interest, furthers the goal of enfranchising shareholders. See
Securities Exchange Act Release No. 60215 (July 1, 2009), 74 FR
33293 (July 10, 2009) (SR-NYSE-2006-92).
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    Based on the above, the Commission finds that the Exchange's
proposal will further the purposes of Sections 6(b)(5) and 6(b)(10) of
the Act because it should enhance corporate accountability to
shareholders while also serving to fulfill the Congressional intent in
adopting Section 6(b)(10) of the Act.
    The Commission also finds good cause, pursuant to Section 19(b)(2)
of the Act,\20\ for approving the proposed rule change prior to the
30th day after the date of publication of notice in the Federal
Register. The Commission believes that good cause exists to grant
accelerated approval to proposed Rule 319(a), because this proposed
rule will conform the Exchange rule to ISE Rule

421, which was published for public comment in the Federal Register and
approved by the Commission, and for which no comments were
received.\21\ Because proposed Rule 319(a) is identical to the ISE
rule, it raises no new regulatory issues.
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    \20\ 15 U.S.C. 78s(b)(2).
    \21\ See supra note 10.
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    The Commission also believes that good cause exists to grant
accelerated approval to proposed Rule 319(b), which conforms the
Exchange's rules to the requirements of Section 6(b)(10) of the Act.
Section 6(b)(10) of the Act, enacted under Section 957 of the Dodd-
Frank Act, does not provide for a transition phase, and requires rules
of national securities exchanges to prohibit broker voting on the
election of a member of the board of directors of an issuer (except for
a vote with respect to the uncontested election of a member of the
board of directors of any investment company registered under the
Investment Company Act of 1940), executive compensation, or any other
significant matter, as determined by the Commission by rule. The
Commission believes that good cause exists to grant accelerated
approval to proposed Rule 3.22(b), because it will conform the Exchange
rule to the requirements of Section 6(b)(10) of the Act. Moreover,
proposed Rule 319(b) is identical to ISE Rule 421.\22\
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    \22\ See supra note 10.
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V. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\23\ that the proposed rule change (SR-MIAX-2013-02) be, and it
hereby is, approved on an accelerated basis.
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    \23\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\24\
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    \24\ 17 CFR 200.30-3(a)(12).
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Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-01970 Filed 1-29-13; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 83, Number 174 (Friday, September 7, 2018)]
[Notices]
[Page 45424]
[FR Doc No: 2018-19387]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP15-521-000]

Gulf LNG Liquefaction Company, LLC, Gulf LNG Energy, LLC, Gulf
LNG Pipeline, LLC; Notice of Anticipated Schedule of Final Order for
the Gulf LNG Liquefaction Project

    On June 19, 2015, Gulf LNG Liquefaction Company, LLC (Gulf
Liquefaction), Gulf LNG Energy, LLC (Gulf Energy), and Gulf LNG
Pipeline LLC (Gulf Pipeline) filed an application pursuant to section
3(a) of the Natural Gas Act (NGA) and Part 153 of the Commission's
regulations, requesting authorization to construct and operate the Gulf
LNG Liquefaction Project (Project) at Gulf Energy's liquefied natural
gas terminal located near Pascagoula, Jackson County, Mississippi. The
Project consists of new natural gas liquefaction and export facilities.
Additionally, within the same application, Gulf Pipeline requested,
pursuant to section 7(c) of the NGA and Part 157 of the Commission's
regulations, to make modifications to the terminal's sendout pipeline
to allow for bi-directional flow. These facilities will enable Gulf
Liquefaction to liquefy and export about 11 million metric tons of LNG
per year.
    In accordance with Title 41 of the Fixing America's Surface
Transportation Act, enacted on December 4, 2015, agencies are to
publish completion dates for all federal environmental reviews and
authorizations. This notice identifies the Commission's anticipated
schedule for issuance of the final order for the Project, which is
based on the anticipated date of issuance of the final Environmental
Impact Statement. Accordingly, we currently anticipate issuing a final
order for the Project no later than:

Issuance of Final Order--July 16, 2019

    If a schedule change becomes necessary for the final order, an
additional notice will be provided so that interested parties and
government agencies are kept informed of the Project's progress.

    Dated: August 31, 2018.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2018-19387 Filed 9-6-18; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 155 (Friday, August 10, 2018)]
[Notices]
[Pages 39761-39763]
[FR Doc No: 2018-17130]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-2582]

Human Dermal (Skin) Safety Testing for Topical Drug Products:
Regulatory Utility and Evaluation; Public Workshop; Request for
Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing the following 1-day public workshop entitled ``Human Dermal
(Skin) Safety Testing for Topical Drug Products: Regulatory Utility and
Evaluation.'' The purpose of the public workshop is to provide a forum
to discuss the current state and future directions of the collection of
human data on the potential skin toxicity with the use of medications
applied topically. The workshop will review current approaches to the
collection of human data during the clinical development of topical
drug products. The workshop will also address the impact of human skin
toxicity studies on drug labeling and consider alternative approaches
to providing information about skin toxicity.

DATES: The public workshop will be held on September 10, 2018, from
8:30 a.m. to 4 p.m. Eastern Time. Submit either electronic or written
comments on this public workshop by October 10, 2018. See the
SUPPLEMENTARY INFORMATION section for registration date and
information.

ADDRESSES: The public workshop will be held at the FDA White Oak
Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the
Great Room (Rm. 1503, Section A), Silver Spring, MD 20993-0002.
Entrance for the public workshop participants (non-FDA employees) is
through Building 1, where routine security check procedures will be
performed. For parking and security information, please refer to
https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    You may submit comments as follows. Please note that late, untimely
filed comments will not be considered. Electronic comments must be
submitted on or before October 10, 2018. The

https://www.regulations.gov electronic filing system will accept
comments until midnight Eastern Time at the end of October 10, 2018.
Comments received by mail/hand delivery/courier (for written/paper
submissions) will be considered timely if they are postmarked or the
delivery service acceptance receipt is on or before that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2018-N-2582 for ``Human Dermal (Skin) Safety Testing for Topical
Drug Products: Regulatory Utility and Evaluation; Public Workshop;
Request for Comments.'' Received comments, those filed in a timely
manner (see ADDRESSES), will be placed in the docket and, except for
those submitted as ``Confidential Submissions,'' publicly viewable at
https://www.regulations.gov or at the Dockets Management Staff between
9 a.m. and 4 p.m., Monday through Friday.
     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.gpo.gov/fdsys/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.

FOR FURTHER INFORMATION CONTACT: Tisha Washington, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing a public workshop entitled ``Human Dermal (Skin)
Safety Testing for Topical Drug Products: Regulatory Utility and
Evaluation'' to discuss the current state and future directions of the
collection of human data on the potential skin risks from use of
topical drug products, including irritancy, sensitization,
phototoxicity, and photoallergenicity.

II. Topics for Discussion at the Public Workshop

    The morning session of the workshop will focus on review and
discussion of current approaches for the collection of human skin
toxicity data, limitations of these approaches, and their impact on
labeling of topical drug products. The afternoon session of the
workshop will be a panel discussion by individuals with different
perspectives about alternative approaches to provide information about
skin toxicity. Thirty minutes of the afternoon session will be
allocated to an open public hearing. The Agency encourages health care
providers, industry representatives, and other interested persons to
attend this public workshop.

III. Participating in the Public Workshop

    Registration: To register for the public workshop, please visit the
following website by September 4, 2018: https://www.eventbrite.com/e/fda-public-workshop-human-dermal-safety-testing-for-topical-drug-products-tickets-47483161414. Please provide complete contact
information for each attendee, including name, title, affiliation,
address, email, and telephone, and intended attendance method--in
person or by webcast. You may also indicate if you wish to present at
the public comment session (see Requests for Oral Presentations). For
those unable to attend in person, FDA will provide a live webcast of
the workshop.
    Registration is free and based on space availability, with priority
given to early registrants. Persons interested in attending this public
workshop must register by 5 p.m. Eastern Time, September 4, 2018. Early
registration is recommended because seating is limited; therefore, FDA
may limit the number of participants from each organization.
Registrants will receive confirmation when they have been accepted.
Seating will be available on a first-come, first-served basis. If time
and space permit, onsite registration on the day of the workshop will
be provided beginning at 8:15 a.m. Eastern Time; FDA will let the
public know whether onsite registration is available before the day of
the public workshop.
    An agenda for the workshop and any other background materials will
be made available 5 days before the workshop at https://www.fda.gov/Drugs/NewsEvents/ucm611203.htm.
    If you need special accommodations due to a disability, please
contact Tisha

Washington, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002,
301-796-1019, [email protected] no later than September 4,
2018.
    Requests for Oral Presentations: During online registration you may
indicate if you wish to present at the public comment session, and
which topic(s) you wish to address. We will do our best to accommodate
requests to make public comments. Individuals and organizations with
common interests are urged to consolidate or coordinate their
presentations, and request time for a joint presentation. Following the
close of registration, we will determine the amount of time allotted to
each presenter and the approximate time each oral presentation is to
begin, and will select and notify participants by September 5, 2018.
All requests to make oral presentations must be received by the close
of registration on September 4, 2018. If selected for presentation, any
presentation materials must be emailed to Tisha Washington (see FOR
FURTHER INFORMATION CONTACT) no later than close of business, September
6, 2018. No commercial or promotional material will be permitted to be
presented or distributed at the public workshop.
    Streaming Webcast of the Public Workshop: This public workshop will
also be webcast. The webcast link will be available on the following
web page 5 days before the workshop at: https://www.fda.gov/Drugs/NewsEvents/ucm611203.htm.
    If you have never attended a Connect Pro event before, test your
connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program,
visit https://www.adobe.com/go/connectpro_overview. FDA has verified
the website addresses in this document, as of the date this document
publishes in the Federal Register, but websites are subject to change
over time.
    Transcripts: Please be advised that as soon as a transcript of the
public workshop is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. A link to the transcript will also be available on
the internet at https://www.fda.gov/Drugs/NewsEvents/ucm611203.htm.

    Dated: August 6, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-17130 Filed 8-9-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 78, Number 135 (Monday, July 15, 2013)]
[Notices]
[Pages 42059-42060]
[FR Doc No: 2013-16835]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Numbers: RP13-1044-000.
    Applicants: Algonquin Gas Transmission, LLC.
    Description: Correct Typographical Error in Exhibit B to AFT-CL
Service Agreement to be effective 8/1/2013.
    Filed Date: 7/3/13.
    Accession Number: 20130703-5041.
    Comments Due: 5 p.m. e.t. 7/15/13.

    Docket Numbers: RP13-1045-000.
    Applicants: Gulf South Pipeline Company, LP.
    Description: Amendment to Neg Rate Agmt (FPL 40097-4) to be
effective 7/2/2013.
    Filed Date: 7/3/13.
    Accession Number: 20130703-5068.
    Comments Due: 5 p.m. e.t. 7/15/13.

    Docket Numbers: RP13-1046-000.
    Applicants: Dominion Transmission, Inc.
    Description: DTI--July 3, 2013 Nonconforming Service Agreement to
be effective 8/1/2013.
    Filed Date: 7/3/13.
    Accession Number: 20130703-5131.
    Comments Due: 5 p.m. e.t. 7/15/13.

    Docket Numbers: RP13-1047-000.
    Applicants: Northwest Pipeline LLC.
    Description: NWP Name Change Filing to be effective 7/12/2013.
    Filed Date: 7/3/13.
    Accession Number: 20130703-5133.
    Comments Due: 5 p.m. e.t. 7/15/13.

    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.

Filings in Existing Proceedings

    Docket Numbers: RP12-15-006.
    Applicants: Gas Transmission Northwest LLC.

    Description: Compliance to RP12-15-004 to be effective 11/11/2011.
    Filed Date: 7/3/13.
    Accession Number: 20130703-5132.
    Comments Due: 5 p.m. e.t. 7/15/13.

    Docket Numbers: RP13-940-001.
    Applicants: Elba Express Company, L.L.C.
    Description: Net Monthly Imbalance Clarification Compliance Filing
to be effective 7/1/2013.
    Filed Date: 7/3/13.
    Accession Number: 20130703-5040.
    Comments Due: 5 p.m. e.t. 7/15/13.

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

    Dated: July 5, 2013.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2013-16835 Filed 7-12-13; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 180 (Friday, September 16, 2011)]
[Rules and Regulations]
[Pages 57633-57634]
[FR Doc No: 2011-23693]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2011-0515; Airspace Docket No. 11-ANM-11]

Amendment of Class E Airspace; Miles City, MT

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: This action modifies Class E airspace at Miles City, MT, to
accommodate aircraft using a new Area Navigation (RNAV) Global
Positioning System (GPS) standard instrument approach procedures at
Frank Wiley Field. Additionally, the geographic coordinates for Frank
Wiley Field are being adjusted. This improves the safety

and management of Instrument Flight Rules (IFR) operations at the
airport.

DATES: Effective date, 0901 UTC, December 15, 2011. The Director of the
Federal Register approves this incorporation by reference action under
1 CFR part 51, subject to the annual revision of FAA Order 7400.9 and
publication of conforming amendments.

FOR FURTHER INFORMATION CONTACT: Eldon Taylor, Federal Aviation
Administration, Operations Support Group, Western Service Center, 1601
Lind Avenue, SW., Renton, WA 98057; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

History

    On July 15, 2011, the FAA published in the Federal Register a
notice of proposed rulemaking to modify controlled airspace at Miles
City, MT (76 FR 41725). Interested parties were invited to participate
in this rulemaking effort by submitting written comments on the
proposal to the FAA. No comments were received.
    Class E airspace designations are published in paragraph 6002 and
6005, respectively, of FAA Order 7400.9V dated August 9, 2011, and
effective September 15, 2011, which is incorporated by reference in 14
CFR 71.1. The Class E airspace designations listed in this document
will be published subsequently in that Order.

The Rule

    This action amends Title 14 Code of Federal Regulations (14 CFR)
part 71 by modifying Class E surface airspace, and Class E airspace
extending upward from 700 feet above the surface, at Frank Wiley Field,
Miles City, MT, to accommodate IFR aircraft executing new RNAV (GPS)
standard instrument approach procedures at the airport. This action
also adjusts the geographic coordinates for Frank Wiley Field to
coincide with the FAA's aeronautical database. This action is necessary
for the safety and management of IFR operations.
    The FAA has determined this regulation only involves an established
body of technical regulations for which frequent and routine amendments
are necessary to keep them operationally current. Therefore, this
regulation: (1) Is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a regulatory evaluation as the
anticipated impact is so minimal. Since this is a routine matter that
will only affect air traffic procedures and air navigation, it is
certified this rule, when promulgated, will not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act. The FAA's authority to
issue rules regarding aviation safety is found in Title 49 of the U.S.
Code. Subtitle 1, Section 106 discusses the authority of the FAA
Administrator. Subtitle VII, Aviation Programs, describes in more
detail the scope of the agency's authority. This rulemaking is
promulgated under the authority described in Subtitle VII, Part A,
Subpart I, Section 40103. Under that section, the FAA is charged with
prescribing regulations to assign the use of airspace necessary to
ensure the safety of aircraft and the efficient use of airspace. This
regulation is within the scope of that authority as it modifies
controlled airspace at Frank Wiley Field, Miles City, MT.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

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

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

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

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

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of the Federal
Aviation Administration Order 7400.9V, Airspace Designations and
Reporting Points, dated August 9, 2011, and effective September 15,
2011 is amended as follows:

Paragraph 6002 Class E airspace designated as surface areas.

* * * * *

ANM MT E2 Miles City, MT [Modified]

Miles City, Frank Wiley Field, MT
    (Lat. 46[deg]25'41'' N., long. 105[deg]53'11'' W.)

    Within a 4.9-mile radius of Frank Wiley Field, and within 3
miles each side of the 226[deg] bearing of Frank Wiley Field
extending from the 4.9-mile radius to 10.8 miles southwest of the
airport, and within 3 miles each side of the 253[deg] bearing of
Frank Wiley Field extending from the 4.9-mile radius to 9.4 miles
west of the airport. This Class E airspace area is effective during
the specific dates and times established in advance by a Notice to
Airmen. The effective date and time will thereafter be continuously
published in the Airport/Facility Directory.

Paragraph 6005 Class E airspace areas extending upward from 700
feet or more above the surface of the earth.

* * * * *

ANM MT E5 Miles City, MT [Modified]

Miles City, Frank Wiley Field, MT
    (Lat. 46[deg]25'41'' N., long. 105[deg]53'11'' W.)

    That airspace extending upward from 700 feet above the surface
within a 7.4-mile radius of Frank Wiley Field, and within 3.1 miles
each side of the 047[deg] bearing from Frank Wiley Field extending
from the 7.4-mile radius to 15.5 miles northeast of the airport, and
within 3.5 miles each side of the 226[deg] bearing from Frank Wiley
Field, extending from the 7.4-mile radius to 15 miles southwest of
the airport, and within 4.5 miles each side of the 253[deg] bearing
from Frank Wiley Field, extending from the 7.4-mile radius to 12
miles west of the airport; that airspace extending upward from 1,200
feet above the surface within a 34.5-mile radius of Frank Wiley
Field.

    Issued in Seattle, Washington, on September 7, 2011.
John Warner,
Manager, Operations Support Group, Western Service Center.
[FR Doc. 2011-23693 Filed 9-15-11; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 77, Number 46 (Thursday, March 8, 2012)]
[Rules and Regulations]
[Pages 13977-13978]
[FR Doc No: 2012-5433]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 60

[EPA-HQ-OAR-2010-0873; FRL-9643-9]
RIN 2060-AH23

Quality Assurance Requirements for Continuous Opacity Monitoring
Systems at Stationary Sources

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule; announcement of extension of comment period.

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

SUMMARY: The EPA is extending the comment period for the direct final
rule titled, ``Quality Assurance Requirements for Continuous Opacity
Monitoring Systems at Stationary Sources,'' that were published in the
Federal Register on February 14, 2012. The 30-day comment period is
scheduled to end on March 15, 2012. The extended comment period will
close on April 30, 2012. The EPA is extending the comment period
because of a request we received in a timely manner.

DATES: The comment period for the direct final February 14, 2012 (77 FR
8160), is extended. Comments must be received on or before April 30,
2012. The effective date for the rule remains April 16, 2012.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OAR-2010-0873 by one of the following methods:
     www.regulations.gov: Follow the on-line instructions for
submitting comments.
     Email<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER>.
     Mail: Attention Docket ID No. EPA-HQ-OAR-2010-0873,
Environmental Protection Agency, Mailcode: 2822T, 1200 Pennsylvania
Ave. NW., Washington, DC 20460.
     Hand Delivery: The EPA Docket Center, EPA West, Room 3334,
1301 Constitution Ave. NW., Washington, DC 20460. Such deliveries are
only accepted during the Docket's normal hours of operation, and
special arrangements should be made for deliveries of boxed
information.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-OAR-
2010-0873. The EPA's policy is that all comments received will be
included in the public docket without change and may be made available
online at www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through www.regulations.gov
or email. The www.regulations.gov Web site is an ``anonymous access''
system, which means the EPA will not know your identity or contact
information unless you provide it in the body of your comment. If you
send an email comment directly to the EPA without going through
www.regulations.gov, your email address will be automatically captured
and included as part of the comment that is placed in the public docket
and made available on the Internet. If you submit an electronic
comment, the EPA recommends that you include your name and other
contact information in the body of your

comment and with any disk or CD-ROM you submit. If the EPA cannot read
your comment due to technical difficulties and cannot contact you for
clarification, the EPA may not be able to consider your comment.
Electronic files should avoid the use of special characters, any form
of encryption, and be free of any defects or viruses. For additional
instructions on submitting comments, go to the SUPPLEMENTARY
INFORMATION section of this document or visit the EPA Docket Center
homepage at http://www.epa.gov/epahome/dockets.htm.
    Docket: All documents in the docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in www.regulations.gov or in hard copy at the Procedure 3--Quality
Assurance Requirements for Continuous Opacity Monitoring Systems at
Stationary Sources Docket, EPA/DC, EPA West, Room 3334, 1301
Constitution Ave. NW., Washington, DC. The Docket Facility and Public
Reading Room are open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Air
Docket is<PHONE_NUMBER>, and the telephone number for the Public
Reading Room is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Ms. Lula H. Melton, U.S. EPA, Office
of Air Quality Planning and Standards, Air Quality Assessment Division,
Measurement Technology Group (Mail Code: E143-02), Research Triangle
Park, NC 27711; telephone number:<PHONE_NUMBER>; fax number: (919)
541-0516; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

A. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to the EPA
through http://www.regulations.gov or email. Send or deliver
information identified as CBI only to the following address: Roberto
Morales, U.S. EPA, Office of Air Quality Planning and Standards, Mail
Code C404-02, Research Triangle Park, NC 27711, telephone: (919) 541-
0880, email<EMAIL_ADDRESS>Attention Docket ID No. EPA-HQ-
OAR-2010-0873. Clearly mark any of the information that you claim to be
CBI. For CBI information in a disk or CD-ROM that you mail to the EPA,
mark the outside of the disk or CD-ROM as CBI and then identify
electronically within the disk or CD-ROM the specific information that
is claimed as CBI. In addition to one complete version of the comment
that includes information claimed as CBI, a copy of the comment that
does not contain the information claimed as CBI must be submitted for
inclusion in the public docket. Information so marked will not be
disclosed except in accordance with procedures set forth in 40 CFR part
2.
    2. Tips for Preparing Your Comments. When submitting comments,
remember to:
     Identify the rulemaking by docket number and other
identifying information (subject heading, Federal Register date and
page number).
     Follow directions--The agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
     Explain why you agree or disagree, suggest alternatives,
and substitute language for your requested changes.
     Describe any assumptions and provide any technical
information and/or data that you used.
     If you estimate potential costs or burdens, explain how
you arrived at your estimate in sufficient detail to allow for it to be
reproduced.
     Provide specific examples to illustrate your concerns, and
suggest alternatives.
     Explain your views as clearly as possible, avoiding the
use of profanity or personal threats.
     Make sure to submit your comments by the comment period
deadline identified.

B. Where can I get a copy of this document?

    In addition to being available in the docket, an electronic copy of
the direct final rule will also be available on the Worldwide Web (WWW)
through the Technology Transfer Network (TTN). Following signature, a
copy of the direct final rule will be posted on the TTN's policy and
guidance page for newly proposed or promulgated rules at the following
address: http://www.epa.gov/ttn/oarpg. The TTN provides information and
technology exchange in various areas of air pollution control.

    Dated: March 1, 2012.
Mary Eileen Henigin,
Acting Director, Office of Air Quality Planning and Standards.
[FR Doc. 2012-5433 Filed 3-7-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 81, Number 243 (Monday, December 19, 2016)]
[Proposed Rules]
[Pages 91880-91882]
[FR Doc No: 2016-29679]

========================================================================
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. 81, No. 243 / Monday, December 19, 2016 /
Proposed Rules

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2015-7491; Directorate Identifier 2015-NE-39-AD]
RIN 2120-AA64

Airworthiness Directives; General Electric Company Turbofan
Engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to supersede airworthiness directive (AD) 2016-13-
05, which applies to all General Electric Company (GE) GE90-76B, GE90-
77B, GE90-85B, GE90-90B, and GE90-94B turbofan engines. AD 2016-13-05
requires eddy current inspection (ECI) of the high-pressure compressor
(HPC) stage 8-10 spool at each shop visit for all affected engines and
ECI or ultrasonic inspection (USI) for certain affected engines. Since
we issued AD 2016-13-05, we determined that the risk of the failure of
an HPC stage 8-10 spool was excessive without repetitive USI prior to
shop visit. This proposed AD would require initial and repetitive on-
wing USIs of the HPC stage 8-10 spool for certain engines prior to shop
visit and ECI of all affected engines at each shop visit. We are
proposing this AD to correct the unsafe condition on these products.

DATES: We must receive comments on this proposed AD by February 2,
2017.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     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: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For service information identified in this NPRM, contact General
Electric Company, GE-Aviation, Room 285, 1 Neumann Way, Cincinnati, OH
45215, phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
You may view this service information at the FAA, Engine & Propeller
Directorate, 1200 District Avenue, 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-
7491; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this proposed AD, the regulatory evaluation, any comments
received, and other information. The street address for the Docket
Office (phone:<PHONE_NUMBER>) is in the ADDRESSES section. Comments will
be available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: John Frost, Aerospace Engineer, Engine
Certification Office, FAA, Engine & Propeller Directorate, 1200
District Avenue, Burlington, MA 01803; phone:<PHONE_NUMBER>; fax: 781-
238-7199; 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-2015-7491;
Directorate Identifier 2015-NE-39-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD because 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 about this proposed AD.

Discussion

    On June 15, 2016, we issued AD 2016-13-05, Amendment 39-18569 (81
FR 41208, June 24, 2016; corrected 81 FR 42475, June 30, 2016) (``AD
2016-13-05''), for GE GE90-76B, GE90-77B, GE90-85B, GE90-90B, and GE90-
94B turbofan engines. AD 2016-13-05 requires an ECI or USI of the HPC
stage 8-10 spool and removing from service those parts that fail
inspection. AD 2016-13-05 resulted from an uncontained failure of the
HPC stage 8-10 spool, leading to an airplane fire. We issued AD 2016-
13-05 to prevent failure of the HPC stage 8-10 spool, uncontained rotor
release, damage to the engine, and damage to the airplane.

Actions Since AD 2016-13-05 Was Issued

    We issued AD 2016-13-05 without including the repetitive USI prior
to shop visit to expedite introduction of the corrective actions to the
fleet. Since we issued AD 2016-13-05, we determined that a repetitive
USI is required based on analysis that the risk of the failure of an
HPC stage 8-10 spool is excessive without this inspection.

Related Service Information

    We reviewed GE GE90 Service Bulletin (SB) SB 72-1151 R00, dated
June 10, 2016. This SB describes procedures for an on-wing USI of the
stage 8 web of the stage 8-10 spool.
    We also reviewed Chapter 72-31-08, Special Procedures 003; and
Chapter 72-00-31, Special Procedures 006, in the GE GE90 Engine Manual,
GEK100700, Revision 68, dated September 1, 2016. These procedures
describe how to perform ECI of the stage 8 aft web of the stage 8-10
spool.

FAA's Determination

    We are proposing this AD because we evaluated all the relevant
information and determined the unsafe condition described previously is
likely to exist or develop in other products of the same type design.

Proposed AD Requirements

    This proposed AD would retain all the requirements of AD 2016-13-
05. This proposed AD would also require repetitive USI of the HPC 8-10
spool.

Interim Action

    We consider this proposed AD interim action. GE is determining the
root cause for the unsafe condition identified in this proposed AD.
Once a root cause is identified, we will consider additional
rulemaking.

Costs of Compliance

    We estimate that this proposed AD affects 54 engines installed on
airplanes of U.S. registry.
    We estimate the following costs to comply with this proposed AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost on U.S.
           Action                  Labor cost         Parts cost       Cost per product          operators
----------------------------------------------------------------------------------------------------------------
Inspection.................  7 work-hours x $85                 $0  $595 per inspection    $32,130 per
                              per hour = $595 per                    cycle.                 inspection cycle.
                              inspection cycle.
----------------------------------------------------------------------------------------------------------------

    We estimate the following costs to do any necessary replacements
that would be required based on the results of the proposed inspection.
We have no way of determining the number of engines that might need
this replacement:

                                               On-Condition Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per
                    Action                                 Labor cost               Parts cost        product
----------------------------------------------------------------------------------------------------------------
Replacement of spool..........................  0 work-hours x $85 per hour = $0        $780,000        $780,000
----------------------------------------------------------------------------------------------------------------

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 have 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 that the 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 removing airworthiness directive (AD)
2016-13-05, Amendment 39-18569 (81 FR 41208, June 24, 2016; corrected
81 FR 42475, June 30, 2016), and adding the following new AD:

General Electric Company: Docket No. FAA-2015-7491; Directorate
Identifier 2015-NE-39-AD.

(a) Comments Due Date

    The FAA must receive comments on this AD action by February 2,
2017.

(b) Affected ADs

    This AD replaces AD 2016-13-05, Amendment 39-18569 (81 FR 41208,
June 24, 2016; corrected 81 FR 42475, June 30, 2016).

(c) Applicability

    This AD applies to General Electric Company (GE) GE90-76B, GE90-
77B, GE90-85B, GE90-90B, and GE90-94B turbofan engines with a high-
pressure compressor (HPC) stage 8-10 spool, part numbers (P/Ns)
1694M80G04, 1844M90G01, or 1844M90G02, installed.

(d) Subject

    Air Transport Association (ATA) of America Code 72, Engine
General.

(e) Unsafe Condition

    This AD was prompted by an uncontained failure of the HPC stage
8-10 spool. We are issuing this AD to prevent failure of the HPC
stage 8-10 spool, uncontained rotor release, damage to the engine,
and damage to the airplane.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.
    (1) For HPC stage 8-10 spool, P/N 1694M80G04, all serial numbers
(S/Ns), or HPC stage 8-10 spool, P/N 1844M90G01 or 1844M90G02, with
a S/N listed in Figure 1 to paragraph (f) of this AD; perform an on-
wing ultrasonic inspection (USI) of the stage 8 aft web upper face
as follows:
    (i) Perform an initial USI after reaching 8,000 cycles since new
(CSN), but, before exceeding 9,000 CSN, or within 500 cycles in

service after July 29, 2016, whichever occurs later.
    (ii) Thereafter, perform a USI of the stage 8 aft web upper face
every 500 cycles since last inspection.
    (iii) Compliance with paragraph (f)(2)(i) of this AD is
terminating action for the initial and repetitive USIs specified by
paragraphs (f)(1)(i) and (f)(1)(ii) of this AD.

                                                  Figure 1 to Paragraph (f)--HPC Stage 8-10 Spool S/Ns
--------------------------------------------------------------------------------------------------------------------------------------------------------

--------------------------------------------------------------------------------------------------------------------------------------------------------
            Part Nos.                                                                   Serial Nos.
                                 -----------------------------------------------------------------------------------------------------------------------
1844M90G01......................  GWN005MF                GWNBK753                GWNBS077                GWNBS497                GWNBS724
                                  GWN005MG                GWNBK754                GWNBS078                GWNBS499                GWNBS794
                                  GWN0087M                GWNBK841                GWNBS079                GWNBS500                GWNBS810
                                  GWN0087N                GWNBK842                GWNBS080                GWNBS501                GWNBS811
                                  GWN00DGK                GWNBK843                GWNBS081                GWNBS502                GWNBS812
                                  GWN00DGL                GWNBK844                GWNBS157                GWNBS609                GWNBS813
                                  GWNBJ992                GWNBK952                GWNBS158                GWNBS610                GWNBS814
                                  GWNBK667                GWNBK953                GWNBS159                GWNBS611                GWNBS910
                                  GWNBK674                GWNBK954                GWNBS160                GWNBS612                GWNBS911
                                  GWNBK675                GWNBK955                GWNBS266                GWNBS613                GWNBS912
                                  GWNBK743                GWNBK956                GWNBS267                GWNBS614                GWNBS914
                                  GWNBK744                GWNBK957                GWNBS268                GWNBS721                GWNBS915
                                  GWNBK751                GWNBK958                GWNBS269                GWNBS722                GWNBS982
                                  GWNBK752                GWNBK959                GWNBS270                GWNBS723                GWNBS983
1844M90G02......................  GWN00C2T                GWN01C5N                GWN02N8D                GWN03RTM                GWN04E21
                                  GWN00C2V                GWN01GE2                GWN02T3R                GWN03RTP                GWN04GHT
                                  GWN00G2N                GWN01GE3                GWN02WGM                GWN040RL                GWN04GHW
                                  GWN00G2P                GWN01GE4                GWN0311K                GWN040RM                GWN04GJ0
                                  GWN00PFP                GWN01GE6                GWN035PP                GWN040RN                GWN04JW6
                                  GWN00PFR                GWN01WH1                GWN038TD                GWN040RP                GWN04JW7
                                  GWN00T2N                GWN02688                GWN039TG                GWN04202                GWN04JW8
                                  GWN00YHV                GWN02689                GWN03G2R                GWN0435W                GWN04L7K
                                  GWN0125G                GWN0268A                GWN03G2W                GWN04360                GWN04L7L
                                  GWN0125H                GWN02DP2                GWN03G30                GWN04361                GWN04MT7
                                  GWN0166K                GWN02DP3                GWN03JPC                GWN04362                GWN04MT8
                                  GWN01C5K                GWN02F9F                GWN03JPD                GWN04ATG                GWNBS984
                                  GWN01C5L                GWN02F9G                GWN03N8P                GWN04ATH                ......................
                                  GWN01C5M                GWN02L9T                GWN03N8R                GWN04E20                ......................
--------------------------------------------------------------------------------------------------------------------------------------------------------

    (2) For all HPC stage 8-10 spools, P/N 1694M80G04, 1844M90G01,
or 1844M90G02, perform an eddy current inspection (ECI) of the stage
8 aft upper face as follows:
    (i) Perform an initial ECI of the stage 8 aft web upper face at
the next shop visit after the effective date of this AD.
    (ii) Thereafter, perform an ECI of the stage 8 aft web upper
face at each subsequent shop visit.
    (3) Remove from service any HPC stage 8-10 spool that fails the
inspection required by paragraphs (f)(1) or (f)(2) of this AD, and
replace with a spool eligible for installation.

 (g) Definition

    For the purpose of this AD, an engine shop visit is the
induction of an engine into the shop for maintenance during which
the compressor discharge pressure seal face is exposed.

 (h) 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>
 (i) Related Information

    (1) For more information about this AD, contact John Frost,
Aerospace Engineer, Engine Certification Office, FAA, 1200 District
Avenue, Burlington, MA 01803; phone:<PHONE_NUMBER>; fax: 781-238-
7199; email<EMAIL_ADDRESS>    (2) GE GE90 Service Bulletin (SB) SB 72-1151 R00, dated June 10,
2016, and Chapter 72-31-08, Special Procedures 003, and Chapter 72-
00-31, Special Procedures 006, in GE GE90 Engine Manual, GEK100700,
Revision 68, dated September 1, 2016, can be obtained from GE using
the contact information in paragraph (i)(3) of this AD. This SB
describes procedures for an on-wing USI of the stage 8 web of the
stage 8-10 spool. These engine manual procedures describe how to
perform ECI of the stage 8 aft web of the stage 8-10 spool.
    (3) For service information identified in this proposed AD,
contact General Electric Company, GE-Aviation, Room 285, 1 Neumann
Way, Cincinnati, OH 45215, phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>;
email<EMAIL_ADDRESS>    (4) You may view this service information at the FAA, Engine &
Propeller Directorate, 1200 District Avenue, Burlington, MA. For
information on the availability of this material at the FAA, call
781-238-7125.

 (j) Material Incorporated by Reference

    None.

    Issued in Burlington, Massachusetts, on November 29, 2016.
Colleen M. D'Alessandro,
Manager, Engine & Propeller Directorate, Aircraft Certification
Service.
[FR Doc. 2016-29679 Filed 12-16-16; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 88, Number 221 (Friday, November 17, 2023)]
[Notices]
[Pages 80317-80318]
[FR Doc No: 2023-25489]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2020-E-2333; FDA-2020-E-2334; FDA-2020-E-2336; and
FDA-2020-E-2337]

Determination of Regulatory Review Period for Purposes of Patent
Extension; ROZLYTREK INJECTION; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; correction.

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

SUMMARY: The Food and Drug Administration (FDA) is correcting a notice
that appeared in the Federal Register of July 8, 2022. The document
announced the determination of the regulatory review period for
ROZLYTREK INJECTION (entrectinib) for purposes of patent extension. The
document was published with an incorrect dosage form. This notice
corrects the dosage form of the drug product.

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

SUPPLEMENTARY INFORMATION:

Correction

    In the Federal Register of July 8, 2022 (87 FR 40849), the dosage
form for the human drug product ROZLYTREK (entrectinib), NDA 212726, is
corrected from ``INJECTION'' to ``CAPSULES'' for all instances
mentioned in the notice. Specifically, the drug product dosage form is
corrected from ``INJECTION'' to ``CAPSULES'' in the following
locations:
    1. On page 40849, the following corrections are made:
     In the second column, the title of the document is
corrected to read: ``Determination of Regulatory Review Period for
Purposes of Patent Extension; ROZLYTREK CAPSULES.''
     In the second column, the first sentence under the SUMMARY
section is corrected to read: ``The Food and Drug Administration (FDA
or the Agency) has determined the regulatory review period for
ROZLYTREK CAPSULES and is publishing this notice of that determination
as required by law.''
     In the third column, the first sentence under the section
Instructions is corrected to read: ``All submissions received must
include the Docket Nos. FDA-2020-E-2333; FDA-2020-E-2334; FDA-2020-E-
2336; and FDA-2020-E-2337 for `Determination of Regulatory Review
Period for Purposes of Patent Extension; ROZLYTREK CAPSULES.'''
    2. On page 40850, the following corrections are made:
     In the second column, under section I. Background of the
SUPPLEMENTARY INFORMATION section, the third paragraph introduction is
corrected to read: ``FDA has approved for marketing the human drug
product, ROZLYTREK CAPSULES (entrectinib), NDA 212726, indicated for
the treatment of:''
     In the second and third columns, under section I.
Background of the SUPPLEMENTARY INFORMATION section, the last paragraph
is corrected to read: ``Subsequent to this approval, the USPTO received
patent term restoration applications for ROZLYTREK CAPSULES (U.S.
Patent Nos. 8,299,057; 8,673,893; 9,029,356; and 9,085,565) from
Genentech, Inc., and the USPTO requested FDA's assistance in
determining the patents' eligibility for patent term restoration. In a
letter dated March 1, 2021, FDA advised the USPTO that this human drug
product had undergone a regulatory review period and that the approval
of ROZLYTREK CAPSULES represented the first permitted commercial
marketing or use of the product. Thereafter, the USPTO requested that
FDA determine the product's regulatory review period.''
     In the third column, under II. Determination of Regulatory
Review Period, the first sentence of the introductory paragraph is
corrected to read: ``FDA has determined that the applicable regulatory
review period for ROZLYTREK CAPSULES is 1,968 days.''
     In the third column, under II. Determination of Regulatory
Review Period, the second sentence of the third paragraph is corrected
to read: ``FDA

has verified the applicant's claims that the new drug application (NDA)
for ROZLYTREK CAPSULES (NDA 212726) was initially submitted on December
18, 2018.''

    Dated: November 14, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-25489 Filed 11-16-23; 8:45 am]
BILLING CODE 4164-01-P


Lydia Wegman/RTP/USEPA/US

06/20/2007 12:16 PM

To

<EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS> cc

<EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS>Tricia Crabtree/RTP/USEPA/US@EPA, <EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS> Subject

Fw: O3 NPR -- secondary standard section -- compare to 6-18-07 version - pdf file

----- Forwarded by Lydia Wegman/RTP/USEPA/US on 06/20/2007 12:15 PM -----

Karen Martin/RTP/USEPA/US

06/20/2007 12:05 PM

To

Wegman Lydia@EPA

cc

Vicki Sandiford/RTP/USEPA/US@EPA, Dave Mckee/RTP/USEPA/US@EPA

Subject

O3 NPR -- secondary standard section -- compare to 6-18-07 version - pdf file

Karen Martin, Ph.D.

Office of Air Quality Planning and Standards

U.S. EPA (C504-06)

Research Triangle Park, NC 27711

phone:<PHONE_NUMBER>

fax:<PHONE_NUMBER>

<EMAIL_ADDRESS>