[Federal Register: August 3, 2007 (Volume 72, Number 149)]
[Notices]
[Page 43266]
[DOCID:fr03au07-64]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP07-536-000]

Transcontinental Gas Pipe Line Corporation; Notice of Proposed
Changes in FERC Gas Tariff

July 27, 2007.
    Take notice that on July 25, 2007, Transcontinental Gas Pipe Line
Corporation (Transco) tendered for filing as part of its FERC Gas
Tariff, Third Revised Volume No. 1, Thirty-Seventh Revised Sheet No.
28, to become effective August 1, 2007.
    Transco states that the purpose of the instant filing is to track
rate changes attributable to storage service purchased from Texas
Eastern Transmission, LP under its Rate Schedule X-28, the costs of
which are included in the rates and charges payable under Transco's
Rate Schedule S-2. This filing is being made pursuant to tracking
provisions under section 26 of the General Terms and Conditions of
Transco's Third Revised Volume No. 1 Tariff.
    Transco states that copies of the filing are being mailed to
affected customers and interested State Commissions.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed in accordance with the provisions of
section 154.210 of the Commission's regulations (18 CFR 154.210).
Anyone filing an intervention or protest must serve a copy of that
document on the Applicant. Anyone filing an intervention or protest on
or before the intervention or protest date need not serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.

Kimberly D. Bose,
Secretary.
 [FR Doc. E7-15071 Filed 8-2-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 144 (Friday, July 30, 2021)]
[Notices]
[Pages 41138-41141]
[FR Doc No: 2021-16226]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-92491; File No. SR-MRX-2021-09]

Self-Regulatory Organizations; Nasdaq MRX, LLC; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Amend the
Opening Process

July 26, 2021.
    Pursuant to 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 July 19, 2021, Nasdaq MRX, LLC (``MRX'' or ``Exchange'') filed with
the Securities and Exchange Commission (``Commission'') the proposed
rule change as described in Items I, II, and III, 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.
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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 proposes to amend MRX Options 3, Section 8, ``Options
Opening Process.''
    The text of the proposed rule change is available on the Exchange's
website at https://listingcenter.nasdaq.com/rulebook/mrx/rules, at the
principal office of the Exchange, 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
    MRX proposes to amend Options 3, Section 8, ``Options Opening
Process.'' Specifically, the Exchange proposes to amend the definition
of Valid Width Quote at Options 3, Section 8(a)(8).
    MRX's Opening Process for an option series is conducted pursuant to
Options 3, Section 8 paragraphs (f)-(j), on or after 9:30 a.m. Eastern
the ABBO, if any, is not crossed and the System has received, within
two minutes \3\ of the opening trade or quote on the market for the
underlying security,\4\ a Valid Width Quote. The System will accept a
Primary Market Maker's Valid Width Quote or the Valid Width Quote of at
least one Competitive Market Maker.\5\ Today, MRX requires a Primary
Market Maker to enter a Valid Width Quote in 90% of their assigned
series, not later than one minute following the dissemination of a
quote or trade by the market for the underlying security.\6\ Primary
Market Makers must promptly enter a Valid Width Quote in the remainder
of their assigned series, which did not open within one minute
following the dissemination of a quote or trade by the market for the
underlying security.\7\ In either case, the Primary Market Maker or
Competitive Market Maker must enter a Valid Width Quote to open an
options series. MRX Options 3, Section 8(a)(8) defines a Valid Width
Quote as follows:
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    \3\ The Exchange may designated a shorter time provided it is
disseminated to membership on the Exchange's website.
    \4\ In the case of index options, the timing is within two
minutes of the receipt of the opening price in the underlying index
or within two minutes of market opening for the underlying security
in the case of U.S. dollar-settled foreign currency options. In both
cases the Exchange may designated a shorter time provided it is
disseminated to membership on the Exchange's website.
    \5\ The Exchange proposes an amendment within Options 3, Section
8(c)(1)(B) as described below.
    \6\ In the case of index options, a Primary Market Maker must
enter a Valid Width Quote in 90% of their assigned series, not later
than one minute following the receipt of the opening price in the
underlying index. The Primary Market Maker assigned in a particular
U.S. dollar-settled foreign currency option must enter a Valid Width
Quote, in 90% of their assigned series, not later than one minute
after the announced market opening. See Options 3, Section 8(c)(3).
The Exchange proposes to make a technical amendment to Options 3,
Section 8(c)(3) which is described below.
    \7\ In the case of index options, Primary Market Makers must
promptly enter a Valid Width Quote in the remainder of their
assigned series, which did not open following the receipt of the
opening price in the underlying index or, with respect to U.S.
dollar-settled foreign currency options, following the announced
market opening. See Options 3, Section 8(c)(3).
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    A ``Valid Width Quote'' is a two-sided electronic quotation
submitted by a Market Maker that meets the following requirements:
Differentials shall be no more than $.25 between the bid and offer for
each options contract for which the bid is less than $2, no more than
$.40 where the bid is at least $2 but does not exceed $5, no more than
$.50 where the bid is more than $5 but does not exceed $10, no more
than $.80 where the bid is more than $10 but does not exceed $20, and
no more than $1 where the bid is $20 or greater, provided that, in the
case of equity options, the bid/ask differentials stated above shall
not apply to in-the-money series where the market for the underlying
security is wider than the differentials set forth above. The bid/ask
differentials for in-the-money options series may be as wide as the
quotation for the underlying security on the primary market, or its
decimal equivalent rounded down to the nearest minimum increment. The
Exchange may establish differences other than the above for one or more
series or classes of options.
    The Exchange proposes to amend a Valid Width Quote to instead
provide:
    A ``Valid Width Quote'' is a two-sided electronic quotation
submitted by a Market Maker that meets the following requirements:
Differentials shall be no more than $5, provided that, in the case of
equity options, the bid/ask differential stated above shall not apply

to in-the-money series where the market for the underlying security is
wider than the differential set forth above. The bid/ask differentials
for in-the-money options series may be as wide as the quotation for the
underlying security on the primary market, or its decimal equivalent
rounded down to the nearest minimum increment. The Exchange may
establish differences other than the above for one or more series or
classes of options. Such differences will be posted by the Exchange on
its website.
    This proposed language is similar to Nasdaq BX, Inc. (``BX'').\8\
The Exchange proposes to widen the current bid/ask differentials for
several reasons.
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    \8\ BX Options 3, Section 8(a)(9) provides, ``A `Valid Width
Quote' is a two-sided electronic quotation, submitted by a Market
Maker, quoted with a difference not to exceed $5 between the bid and
offer regardless of the price of the bid. However, respecting in-
the-money series where the market for the underlying security is
wider than $5, the bid/ask differential may be as wide as the
quotation for the underlying security on the primary market, or its
decimal equivalent rounded down to the nearest minimum increment.
The Exchange may establish differences other than the above for one
or more series or classes of options.'' See also Securities Exchange
Act Release No. 89731 (September 1, 2020), 85 FR 55524 (September 8,
2020) (SR-BX-2020-016) (Order Approving Proposed Rule Change To
Amend BX's Opening Process in Connection With a Technology
Migration).
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    First, the proposal would conform the Valid Width Quote definition
of MRX to that of BX. BX refers to a difference not to exceed $5
between the bid and offer within the description of a Valid Width
Quote, similar to BX Options 2, Section 4(f) and 5(d)(2) that describes
intra-day quotes. By amending MRX's Valid Width Quote, the Exchange
notes that the $5 difference is akin to MRX's intra-day requirement
within MRX Options 2, Section 4(b)(4).\9\
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    \9\ MRX Options 2, Section 4(b)(4) provides, ``. . . To price
options contracts fairly by, among other things, bidding and
offering so as to create differences of no more than $5 between the
bid and offer following the opening rotation in an equity or index
options contract. The Exchange may establish differences other than
the above for one or more series or classes of options.'' Intra-day,
MRX also distinguishes in-the-money options series where the
underlying securities market is wider than the differentials set
forth above. For these series, the bid/ask differential may be as
wide as the spread between the national best bid and offer in the
underlying security.
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    Second, the proposed differential would simplify the differential
for Primary Market Makers, who would continue to be required to submit
a Valid Width Quote during the Opening Process in their assigned
options series. Widening the differentials would allow Primary Market
Makers and Competitive Market Makers that elect to quote during the
Opening Process, an ability to quote wider during the Opening Process
when an underlying is volatile. Today, pursuant to Options 3, Section
8(a)(8), the Exchange may establish differences other than the
established bid/ask differentials for one or more series or classes of
options. With this proposal, the Exchange is not amending its ability
to continue to establish differences for one or more series or classes
of options, rather the Exchange may continue to set other requirements
pursuant to current MRX Options 3, Section 8(a)(8). Today, the Exchange
has established Valid Width Quote differentials which differ from those
described within Options 3, Section 8(a)(8),\10\ they are:
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    \10\ See https://www.nasdaq.com/docs/2021/03/22/MRXSystemSetting.pdf.

------------------------------------------------------------------------
                                                     Maximum bid/ask
  Bid price low end of    Bid price high end of        differential
------------------------------------------------------------------------
            $0.00                    $1.99                   $0.75
             2.00                     4.99                    1.20
             5.00                     9.99                    1.50
            10.00                    19.99                    2.40
            20.00                   20.00+                    3.00
------------------------------------------------------------------------

Also, options with an expiration more than nine months away continue to
be permitted a Valid Width Quote bid/ask differential of $5.00. The
Exchange will continue to utilize the differentials currently posted on
its website until such time as it provides notice to Members of a
change.
    Third, the Exchange also proposes to add rule text to state that
such differences will be posted by the Exchange on its website.\11\
Posting the current differentials on its website would allow Members to
easily refer to the quoting obligations for the Opening Process.
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    \11\ Id.
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Technical Amendment
    The Exchange proposes to amend ``Quotes'' to ``Quote'' within
Options 3, Section 8(c)(1)(B). The Exchange also proposes to remove two
incorrect citations to Options 3, Section 8(c)(1)(iii). The ``iii'' was
removed in a prior rule change.\12\
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    \12\ See Securities Exchange Act Release No. 88660 (April 16,
2020), 85 FR 22482 (April 22, 2020) (SR-MRX-2020-09) (Notice of
Filing and Immediate Effectiveness of Proposed Rule Change To Amend
Options 3, Section 8, Relating to the Options Opening Process).
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2. Statutory Basis
    The Exchange believes that its proposal to establish a $5
difference is consistent with Section 6(b) of the Act.\13\
Specifically, the Exchange believes the proposed rule change is
consistent with the Section 6(b)(5) \14\ requirements that the rules of
an exchange be designed to prevent fraudulent and manipulative acts and
practices, to promote just and equitable principles of trade, to foster
cooperation and coordination with persons engaged in regulating,
clearing, settling, processing information with respect to, and
facilitating transactions in securities, to 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.
Additionally, the Exchange believes the proposed rule change is
consistent with the Section 6(b)(5) \15\ requirement that the rules of
an exchange not be designed to permit unfair discrimination between
customers, issuers, brokers, or dealers.
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    \13\ 15 U.S.C. 78f(b).
    \14\ 15 U.S.C. 78f(b)(5).
    \15\ Id.
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    The Exchange believes that the proposed $5 difference for the Valid
Width Quote is more appropriate because it reflects the Exchange's
experience in administering the rule and would continue to give Market
Makers flexibility including during the Opening Process. The Exchange
notes that the current standard is not being applied as the Exchange
has established Valid Width Quote differentials which differ from those
described within Options 3, Section 8(a)(8).\16\ Widening the Valid
Width Quote requirement would provide Primary Market Makers, and
Competitive Market Makers that elect to quote during the Opening
Process, additional flexibility when submitting Valid Width Quotes
during the Opening Process thereby allowing these Market Makers the
ability to quote wider in instances where the Exchange has not
established Valid Width Quote differentials which differ from those in
the rule because volatile market conditions exist or there is news
regarding an underlying security which may impact pricing. Primary
Market Makers are integral to the Exchange's Opening Process as MRX is
dependent on receiving a Valid Width Quote to open an options series.
With this proposal, Primary Market Makers would continue to be required
to submit a Valid Width Quote during the Opening Process in their
assigned options series.\17\
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    \16\ See supra note 10.
    \17\ Today, MRX, Nasdaq GEMX, LLC (``GEMX''), Nasdaq ISE, LLC
(``ISE''), Nasdaq Phlx LLC (``Phlx''), Miami International
Securities Exchange, LLC (``MIAX'') and MIAX Emerald, LLC
(``Emerald'') and are the only options markets that require a
Primary Market Maker, or Lead Market Maker in the case of Phlx, to
submit a quote to open an options series.
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    The proposal would conform the Valid Width Quote definition of MRX
to

that of BX.\18\ BX refers to a difference not to exceed $5 between the
bid and offer within the description of a Valid Width Quote, similar to
BX Options 2, Section 4(f) and 5(d)(2) that describes intra-day quotes.
By amending MRX's Valid Width Quote, the Exchange notes that the $5
difference is akin to MRX's intra-day requirement within MRX Options 2,
Section 4(b)(4).\19\ Also, today, MIAX and Emerald require market
makers to enter a valid width NBBO with a difference of no more than $5
between the bid and offer.\20\
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    \18\ See supra note 8.
    \19\ See supra note 9.
    \20\ MIAX and Emerald require Market Makers to submit a valid
width NBBO in the opening where the bid and offer of the NBBO differ
no more than differences outlined in MIAX and Emerald Rule
603(b)(4)(i). MIAX and Emerald Rule 603(b)(4)(i) provides that
bidding and offering so as to create differences of no more than $5
between the bid and offer. Rule 603(b)(4)(ii) provides MIAX and
Emerald may establish differences other than the bid/ask
differentials described in (i) above for one or more option series
or classes, respectively. See MIAX and Emerald Rules 503.
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    Not all options markets have bid/ask differentials. In 2019, Cboe
removed its quote width requirements while citing corresponding rules
of its affiliated exchanges.\21\ Cboe noted in the 2019 Rule Change
that the current quote width requirement at the time for generally all
classes was $10, however, its Market-Makers consistently maintained
two-sided quotes that were much tighter than the required width. Cboe
opined that, even if markets experienced periods of stress or
volatility, they remained obligated to maintain two sided markets and
engage in a course of dealings that must be reasonably calculated to
contribute to the maintenance of a fair and orderly market, which
includes refraining from making bids or offers that are inconsistent
with such course of dealings and updating quotations in response to
changed market conditions.\22\ Cboe noted that it did not believe that
continuing to provide for a quote width requirement was necessary nor
would it impact the maintenance of fair and orderly markets because
Market-Makers already quoted at a bid/ask spread much narrower than the
requirements and were required to continuously fulfill their
obligations to engage in a course of dealings reasonably calculated to
contribute to the maintenance of a fair and orderly market.\23\
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    \21\ See Securities Exchange Act Release No. 87024 (September
19, 2019), 84 FR 50545 (September 25, 2019) (SR-Cboe-2019-059)
(``2019 Rule Change'').
    \22\ Id.
    \23\ Id.
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    Unlike Cboe, MRX does require its Market Makers to quote both
during the Opening Process and intra-day within certain established
bid/ask differentials. The Exchange notes that widening its Valid Width
Quote differential during the Opening Process will not impact the
maintenance of fair and orderly markets because Market Makers on MRX,
unlike other markets that do not require quoting during the Opening
Process, will continue to require that its Market Makers provide Valid
Width Quotes during the Opening Process, thereby ensuring liquidity.
Also, Market Makers may quote tighter than the defined Valid Width
Quote differential. Finally, similar to Cboe's argument in the 2019
Rule Change, Market Makers are required to continuously fulfill their
obligations to engage in a course of dealings reasonably calculated to
contribute to the maintenance of a fair and orderly market.
    Today, the Exchange has discretion to set other differentials,\24\
similar to MIAX and Emerald.\25\ The Exchange currently is utilizing
that discretion to set different bid/ask differentials based on its
observation of market openings. Currently, the Exchange requires Market
Makers to submit Valid Width Quotes which are tighter than the proposed
$5 difference.
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    \24\ See Options 3, Section 8(a)(8), the Exchange may establish
differences other than the established bid/ask differentials for one
or more series or classes of options.
    \25\ See MIAX and Emerald Rules 503.
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    The Exchange's robust Opening Process seeks to encourage quality
markets. As noted herein, unlike a majority of options markets,\26\ it
requires Primary Market Makers to quote during the Opening Process to
ensure liquidity as well as an efficient Opening Process where options
series are opened quickly and at fair prices.
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    \26\ See supra note 17.
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    The proposal to add rule text to state that such differences will
be posted by the Exchange on its website \27\ would allow Members to
easily refer to the quoting obligations for the Opening Process.
---------------------------------------------------------------------------

    \27\ Id.
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Technical Amendment
    The Exchange's proposal to amend ``Quotes'' to ``Quote'' within
Options 3, Section 8(c)(1)(B) and remove two incorrect citations to
Options 3, Section 8(c)(1)(C) will bring greater clarity to the
Exchange's Rules.

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 Exchange's proposal to
require Primary Market Makers and Competitive Market Makers to bid and/
or offer an option series with differences of no more than $5 for
options on equities and index options does not impose an undue burden
on competition. All Primary Market Makers, and Competitive Market
Makers who elect to quote during the Opening Process, would be subject
to the same requirement to submit a Valid Width Quote when submitting
quotes during the Opening Process. Differentials would be available on
the Exchange's website and therefore transparent, allowing Members to
easily refer to the quoting obligations for the Opening Process.
Finally, the proposal would also align quoting requirements more
closely to intra-day requirements within MRX Options 2, Section
4(b)(4).
    With respect to inter-market competition, the Exchange notes that
most options markets do not require market makers to quote during the
opening.\28\ The Exchange notes that MIAX and Emerald have quoting
requirements in the opening similar to the differential proposed
herein. Also, ISE, GEMX and Phlx are filing similar rule changes to
this proposal.\29\
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    \28\ See supra note 17 citing the options markets that require
bid/ask differentials.
    \29\ See SR-ISE-2021-17, SR-GEMX-2021-07 and SR-Phlx-2021-42.
These rule changes are not yet noticed.
---------------------------------------------------------------------------

Technical Amendment
    Exchange's proposal to amend ``Quotes'' to ``Quote'' within Options
3, Section 8(c)(1)(B) and remove two incorrect citations to Options 3,
Section 8(c)(1)(C) will bring greater clarity to the Exchange's Rules.

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

    No written comments were either solicited or received.

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

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A)(iii) of the Act \30\ and

subparagraph (f)(6) of Rule 19b-4 thereunder.\31\
---------------------------------------------------------------------------

    \30\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \31\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Exchange has satisfied this requirement.
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule should be approved or disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-MRX-2021-09 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-MRX-2021-09. 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 website (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 website 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. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-MRX-2021-09 and should be submitted on
or before August 20, 2021.
---------------------------------------------------------------------------

    \32\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\32\
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2021-16226 Filed 7-29-21; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 76, Number 188 (Wednesday, September 28, 2011)]
[Notices]
[Pages 60025-60028]
[FR Doc No: 2011-24832]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2009-1017; FRL-8889-7]

Product Cancellation Order for Certain Pesticide Registrations

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces EPA's order for the cancellations,
voluntarily requested by the registrants and accepted by the Agency, of
the products listed in Tables 1, 2, and 3 of Unit II., pursuant to
section 6(f)(1) of the Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA), as amended. This cancellation order follows an August 5,
2011 Federal Register Notice of Receipt of Requests from the
registrants listed in Table 4 of Unit II. to voluntarily cancel these
product registrations. In the August 5, 2011 notice, EPA indicated that
it would issue an order implementing the cancellations, unless the
Agency received substantive comments within the 30-day comment period
that would merit its further review of these requests, or unless the
registrants withdrew their requests. The Agency did not receive any
comments on the notice. Further, the registrants did not withdraw their
requests. Accordingly, EPA hereby issues in this notice a cancellation
order granting the requested cancellations. Any distribution, sale, or
use of the products subject to this cancellation order is permitted
only in accordance with the terms of this order, including any existing
stocks provisions.

DATES: The cancellations are effective September 28, 2011.

FOR FURTHER INFORMATION CONTACT: Maia Tatinclaux, Pesticide Re-
evaluation Division (7508P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; fax
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    This action is directed to the public in general, and may be of
interest to a wide range of stakeholders including environmental, human
health, and agricultural advocates; the chemical industry; pesticide
users; and members of the public interested in the sale, distribution,
or use of pesticides. Since others also may be interested, the Agency
has not attempted to describe all the specific entities that may be
affected by this action. If you have any questions regarding the
applicability of this action to a particular entity, consult the person
listed under FOR FURTHER INFORMATION CONTACT.

B. How can I get copies of this document and other related information?

    EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2009-1017. Publicly available
docket materials are available either in the electronic docket at
http://www.regulations.gov, or, if only available in hard copy, at the
Office of Pesticide Programs (OPP) Regulatory Public Docket in Rm. S-
4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington,
VA. The hours of operation of this Docket Facility are from 8:30 a.m.
to 4 p.m., Monday through Friday, excluding legal holidays. The Docket
Facility telephone number is<PHONE_NUMBER>.

II. What action is the agency taking?

    This notice announces the cancellation, as requested by
registrants, of 45 products registered under FIFRA section 3. These
registrations are listed in sequence by registration number in Tables
1, 2, and 3 of this unit.

                                         Table 1--Product Cancellations
----------------------------------------------------------------------------------------------------------------
              EPA Reg. No.                      Product name                      Active ingredients
----------------------------------------------------------------------------------------------------------------
000239-02373...........................  Bug-Geta Snail and Slug     Metaldehyde
                                          Pellets.
000279-03053...........................  Command 4EC Herbicide.....  Clomazone
000279-03071...........................  Command 4E Herbicide......  Clomazone
000538-00199...........................  Scotts Turf Manager for     Paclobutrazol
                                          St. Augustine Grass.
000538-00201...........................  Scotts Turf Manager II....  Paclobutrazol
001270-00254...........................  Zep FS CIP Acid Sanitizer.  Phosphoric Acid Dodecybenzenesulfonic acid
001448-00047...........................  Busan 52..................  Carbamodithioic acid, methyl-,
                                                                      monopotassium salt
001448-00389...........................  D-33-5....................  Potassium dimethyldithiocarbamate
001448-00390...........................  D-33-6....................  Potassium dimethyldithiocarbamate
001448-00391...........................  D-33-7....................  Potassium dimethyldithiocarbamate
001448-00392...........................  D-33-8....................  Potassium dimethyldithiocarbamate
001448-00429...........................  Diald 25P.................  Glutaraldehyde
001448-00430...........................  Diald 15P.................  Glutaraldehyde
001448-00431...........................  Diald 45P.................  Glutaraldehyde
002596-00132...........................  Hartz Sumithrin Carpet      MGK-264 Sumithrin
                                          Powder.
002724-00697...........................  Permanone H and G Insect    Permethrin
                                          Control.
004822-00531...........................  Raid 1000.................  Triethylene glycol
006959-00082...........................  Cessco Accudose Aerosol     Pyrethrins Piperonyl butoxide
                                          Insecticide.
047000-00171...........................  SMCP Pyrethrum Dust 1%....  Pyrethrins
061483-00086...........................  10% Permectrin Pour-On      Permethrin
                                          Insecticide.
069592-00002...........................  Laginex AS................  Lagenidium giganteum, mycelium or oospores
069592-00003...........................  Technical Laginex.........  Lagenidium giganteum, mycelium or oospores
070506-00202...........................  Penncozeb EG Raincote.....  Mancozeb

080490-00002...........................  Promeris Spot on for Dogs.  Amitraz 4-{(2Z)-2-({[4-(Trifluoromethoxy)
                                                                     Anilino]Carbonyl{time} Hydrazono)-2-[3-
                                                                      (Trifluoromethyl)
                                                                     Phenyl]Ethyl{time} Benzonitrile
                                                                     Metaflumizone
080490-00003...........................  Promeris Spot on for Cats.  4-{(2Z)-2-({[4-(Trifluoromethoxy)
                                                                     Anilino]Carbonyl{time} Hydrazono)-2-[3-
                                                                      (Trifluoromethyl)
                                                                     Phenyl]Ethyl{time} Benzonitrile
                                                                     Metaflumizone
080490-00004...........................  Promeris for Dogs--Flea     4-{(2Z)-2-({4-(Trifluoromethoxy)
                                          Control.                   Anilino]Carbonyl{time} Hydrazono)-2-[3-
                                                                      (Trifluoromethyl)
                                                                     Phenyl]Ethyl{time} Benzonitrile
                                                                     Metaflumizone
081598-00010...........................  Glyphosate Acid Technical.  Glyphosate
083100-00029...........................  Glyphosate 62%              Glyphosate-isopropylammonium
                                          Manufacturing Concentrate.
087650-00001...........................  Fipronil Technical........  Fipronil
CA920028...............................  Devrinol 50-DF Selective    Napropamide
                                          Herbicide.
CO100002...............................  Endigo ZC.................  Thiamethoxam lambda-Cythalothrin
ND900005...............................  Vitavax-200 Flowable        Thiram Carboxin
                                          Fungicide (Vitavax with
                                          Thiram).
----------------------------------------------------------------------------------------------------------------

Table 2--Product Cancellations Containing Methyl bromide or Chloropicrin
------------------------------------------------------------------------
         EPA Reg. No.            Product name       Active ingredients
------------------------------------------------------------------------
005785-00017.................  Chlor-O-Pic.....  Chloropicrin
005785-00025.................  Terr-O-Gas 33     Chloropicrin Methyl
                                Preplant Soil     bromide
                                Fumigant.
008536-00012.................  Methyl Bromide    Methyl bromide
                                99.5%.
CA900038.....................  Methyl Bromide    Methyl bromide
                                99.5%.
CA900045.....................  Methyl Bromide    Methyl bromide
                                99.5%.
CA910003.....................  Methyl Bromide    Methyl bromide
                                99.5%.
CA910020.....................  Methyl Bromide    Methyl bromide
                                99.5%.
CA970017.....................  Methyl Bromide    Methyl bromide
                                99.5%.
ID070004.....................  MBC Concentrate   Methyl bromide
                                Soil Fumigant.
------------------------------------------------------------------------

          Table 3--Product Cancellations Containing Carbofuran
------------------------------------------------------------------------
         EPA Reg. No.            Product name       Active ingredients
------------------------------------------------------------------------
000279-02712.................  Furadan 10 G      Carbofuran
                                Insecticide/
                                Nematicide.
000279-02876.................  Furadan 4F        Carbofuran
                                Insecticide/
                                Nematicide.
000279-03023.................  Furadan 15 G       Carbofuran
                                Insecticide/
                                Nematicide.
000279-03310.................  Furadan LFR       Carbofuran
                                Insecticide/
                                Nematicide.
------------------------------------------------------------------------

    Table 4 of this unit includes the names and addresses of record for
all registrants of the products in Tables 1, 2, and 3 of this unit, in
sequence by EPA company number. This number corresponds to the first
part of the EPA registration numbers of the products listed in Tables
1, 2, and 3 of this unit.

               Table 4--Registrants of Cancelled Products
------------------------------------------------------------------------
         EPA Co. No.                    Company name and address
------------------------------------------------------------------------
239..........................  The Scotts Company, P.O. Box 190,
                                Marysville, OH 43040.
279..........................  FMC Corp. Agricultural Products Group,
                                ATTN: Michael C. Zucker, 1735 Market
                                St., Rm. 1978, Philadelphia, PA 19103.
538..........................  The Scotts Company, 14111 Scottslawn Rd.,
                                Marysville, OH 43041.
1270.........................  ZEP, Inc., 1310 Seaboard Industrial
                                Blvd., NW., Atlanta, GA 30318.

1448.........................  Buckman Laboratories, Inc., 1256 North
                                McLean Blvd., Memphis, TN 38108.
2596.........................  The Hartz Mountain Corp., 400 Plaza Dr.,
                                Secaucus, NJ 07094.
2724.........................  Wellmark International, 1501 E. Woodfield
                                Rd., Suite 200 West, Schaumburg, IL
                                60173.
4822.........................  S.C. Johnson and Son Inc., 1525 Howe St.,
                                Racine, WI 53403.
5785.........................  Great Lakes Chem Corp., Agent: Chemtura
                                Corporation, 1801 Highway 52 West, West
                                Lafayette, IN 47906.
6959.........................  Cessco, Inc., 3609A River Rd., John's
                                Island, SC 29455.
8536.........................  Soil Chemicals Corp., P.O. Box 782,
                                Hollister, CA 95024.
47000........................  Chem-Tech, Ltd., 4515 Fleur Dr., 303, Des Moines, IA 50321.
61483........................  KMG-Bernuth, Inc., 9555 W. Sam Houston
                                Pkwy South, Suite 600, Houston, TX
                                77099.
69592........................  Agraquest, Inc., 1540 Drew Ave., Davis,
                                CA 95618-6320.
70506........................  United Phosphorus, Inc., 630 Freedom
                                Business Center, Suite 402, King of
                                Prussia, PA 19406.
80490........................  Fort Dodge Animal Health, 7000 Portage
                                Rd., KZO 300-403 SW., Kalamazoo, MI
                                49001.
81598........................  Rotam Limited Agent: IPM Resources LLC,
                                4032 Crockers Lake Blvd., Suite 818,
                                Sarasota, FL 43238.
83100........................  Rotam Agrochemical Company, Ltd., Agent:
                                IPM Resources LLC, 4032 Crockers Lake
                                Blvd., Suite 818, Sarasota, FL 43238.
87650........................  Fipronex Solutions, Inc., Agent:
                                Technology Sciences Group, Inc., 1150
                                18th St., NW., Suite 1000, Washington,
                                DC 20036.
CA900038;CA900045;CA910003;    Soil Chemicals Corp., P.O. Box 782,
 CA910020;CA970017.             Hollister, CA 95024.
CA920028.....................  Easter Lily Research Foundation, P.O. Box
                                907, Brookings, OR 97415.
CO100002.....................  Syngenta Crop Protection, LLC, P.O. Box
                                18300, Greensboro, NC 27419-8300.
ID070004.....................  TriCal, Inc., P.O. Box 1327, Hollister,
                                CA 95024-1327.
ND900005.....................  Chemtura Corp., 199 Benson Rd. (2-5),
                                Middlebury, CT 06749.
------------------------------------------------------------------------

III. Summary of Public Comments Received and Agency Response to
Comments

    During the public comment period provided, EPA received no comments
in response to the August 5, 2011 Federal Register notice (76 FR 47579)
(FRL-8882-9) announcing the Agency's receipt of the requests for
voluntary cancellations of products listed in Tables 1, 2, and 3 of
Unit II.

IV. Cancellation Order

    Pursuant to FIFRA section 6(f), EPA hereby approves the requested
cancellations of the registrations identified in Tables 1, 2, and 3 of
Unit II. Accordingly, the Agency hereby orders that the product
registrations identified in Tables 1, 2, and 3 of Unit II. are
cancelled. The effective date of the cancellations that are subject of
this notice is September 28, 2011. Any distribution, sale, or use of
existing stocks of the products identified in Tables 1, 2, and 3 of
Unit II. in a manner inconsistent with any of the provisions for
disposition of existing stocks set forth in Unit VI. will be a
violation of FIFRA.

V. What is the agency's authority for taking this action?

    Section 6(f)(1) of FIFRA provides that a registrant of a pesticide
product may at any time request that any of its pesticide registrations
be cancelled or amended to terminate one or more uses. FIFRA further
provides that, before acting on the request, EPA must publish a notice
of receipt of any such request in the Federal Register. Thereafter,
following the public comment period, the EPA Administrator may approve
such a request. The notice of receipt for this action was published for
comment in the Federal Register issue of August 5, 2011. The comment
period closed on September 6, 2011.

VI. Provisions for Disposition of Existing Stocks

    Existing stocks are those stocks of registered pesticide products
that are currently in the United States and that were packaged,
labeled, and released for shipment prior to the effective date of the
cancellation action. Upon cancellation of the products identified in
Tables 1, 2, and 3 of Unit II., EPA will allow existing stocks
provisions as follows:

A. Registrations Listed in Table 1 of Unit II Except Nos.<PHONE_NUMBER>2,
080490-00003,<PHONE_NUMBER>4

    The Agency will allow registrants to sell and distribute existing
stocks of these products until September 28, 2012. Thereafter,
registrants are prohibited from selling or distributing the pesticides
identified in Table 1 of Unit II., except for export consistent with
FIFRA section 17 or for proper disposal. Persons other than registrants
will generally be allowed to sell, distribute, or use existing stocks
until such stocks are exhausted, provided that such sale, distribution,
or use is consistent with the terms of the previously approved labeling
on, or that accompanied, the cancelled products.

B. Registration Nos.<PHONE_NUMBER>2,<PHONE_NUMBER>3,<PHONE_NUMBER>4

    The Agency will allow registrants to sell and distribute existing
stocks of these products through September 30, 2011. Thereafter,
registrants are prohibited from selling or distributing these pesticide
products, except for export consistent with FIFRA section 17 or for
proper disposal. Persons other than registrants will generally be
allowed to sell, distribute, or use existing stocks until such stocks
are exhausted, provided that such sale, distribution, or use is
consistent with the terms of the previously approved labeling on, or
that accompanied, the cancelled products.

C. Registrations Listed in Table 2 of Unit II

    The effective date of cancellation of these products is September
28, 2011. The registrants are allowed to sell and distribute existing
stocks until December 31, 2011. Thereafter, registrants are prohibited
from selling or distributing these pesticide products, except for
export consistent with FIFRA section 17 or for proper disposal.
    Persons other than the registrant will be allowed to sell and
distribute existing stocks through April 30, 2012. After this date,
remaining existing stocks may be

used until exhausted, provided that such use complies with the EPA-
approved label and labeling of the product.

D. Registrations Listed in Table 3 of Unit II

    The effective date of cancellation of these products is September
28, 2011. EPA will not allow the continued sale and distribution of
existing stocks of these products after the effective date of this
cancellation for several reasons. First, there are currently no
tolerances in effect for any of the food or feed crops associated with
the domestic use of these products, and there have been none since the
2009 tolerance revocations took effect on December 31, 2009 (May 15,
2009, 74 FR 23046; FRL-8413-3). In addition, the Agency believes that
little, if any existing stock remains in the hands of retailers, based
on the sole registrant's repeated representation that no carbofuran
products have been released for shipment since January 2010, and that
they have offered to buy back unused carbofuran products. Consequently,
sale of existing stocks of carbofuran is prohibited as of September 28,
2011. Users may only use those carbofuran products labeled for non-food
use (ornamentals, spinach grown for seed, and pine seedlings) on those
specific crops and in accordance with all geographical restrictions.
Any food or feed crops with carbofuran residues after this date will be
considered adulterated and subject to seizure.

List of Subjects

    Environmental protection, Pesticides and pests.

    Dated: September 21, 2011.
 Richard P. Keigwin, Jr.,
Director, Pesticide Re-evaluation Division, Office of Pesticide
Programs.
[FR Doc. 2011-24832 Filed 9-27-11; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 79, Number 194 (Tuesday, October 7, 2014)]
[Rules and Regulations]
[Pages 60325-60327]
[FR Doc No: 2014-23555]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2014-0740; Directorate Identifier 2014-CE-030-AD;
Amendment 39-17978; AD 2014-20-05]
RIN 2120-AA64

Airworthiness Directives; Empresa Brasileira de Aeronautica S. A.
(EMBRAER) Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; request for comments.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for Empresa
Brasileira de Aeronautica S. A. (EMBRAER) Models EMB-110P1 and EMB-
110P2 airplanes. This AD results from mandatory continuing
airworthiness information (MCAI) issued by the aviation authority of
another country to identify and correct an unsafe condition on an
aviation product. The MCAI describes the unsafe condition as corrosion
and cracking on the rudder trim tab actuator terminal. We are issuing
this AD to require actions to address the unsafe condition on these
products.

DATES: This AD is effective October 27, 2014.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in the AD as of October 27,
2014.
    We must receive comments on this AD by November 21, 2014.

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.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
    For service information identified in this AD, contact Embraer--
S.A., EFTC--Service Bulletin Engineering, Avenida Brigadeiro Faria
Lima, 2170, S[atilde]o Jos[eacute] dos Campos--SP--12227-901, Brasil;
phone: +55 12 3927 1000; fax: +55 12 3927-6600 (ext. 1624); email:
<EMAIL_ADDRESS>internet: http://www.flyembraer.com.
You may view this referenced service information at the FAA, Small
Airplane Directorate, 901 Locust, Kansas City, Missouri 64106. For
information on the availability of this material at the FAA, call (816)
329-4148.

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-2014-
0740; 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 AD, the regulatory evaluation, any comments received, and
other information. The street address for the Docket Office (telephone
(800) 647-5527) is in the ADDRESSES section. Comments will be available
in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Jim Rutherford, Aerospace Engineer,
FAA, Small Airplane Directorate, 901 Locust, Room 301, Kansas City,
Missouri 64106; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    The Ag[ecirc]ncia Nacional de Avia[ccedil][atilde]o Civil (ANAC),
which is the aviation authority for Brazil, has issued AD No.: 2014-09-
01, dated September 4, 2014 (referred to after this as ``the MCAI''),
to correct an unsafe condition for Empresa Brasileira de Aeronautica S.
A. (EMBRAER) Models EMB-110P1 and EMB-110P2 airplanes. The MCAI states:

    This AD was prompted by a report of an in-service occurrence
were an EMB-110 airplane performed a forced landing, due to a strong
vibration felt by the pilots after the takeoff. The investigation
determined that the cause of the vibration most likely resulted from
a broken fork end on the rudder trim tab actuator that connects the
trim tab to the trim tab actuator due to severe corrosion. We are
issuing this AD to detect and correct corrosion and cracking on the
rudder trim tab actuator terminal, which could cause the terminal to
fail and result in loss of control of the airplane.
    Since this condition may exist in other airplanes of the same
type and affects flight safety, an immediate corrective action is
required. Thus, sufficient reason exists to request compliance with
this AD in the indicated time limit without prior notice.

This AD requires inspection of the rudder trim tab actuator components
to detect discrepancies and corrosion on the rudder trim tab actuator
components and, if any discrepancy exists, repair before further flight
is required. You may examine the MCAI on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2014-
0740.

Relevant Service Information

    Empresa Brasileira de Aeronautica S. A. (EMBRAER) has issued
EMBRAER Alert Service Bulletin SB No.: 110-27-A095, dated August 21,
2014. The actions described in this service information are intended to
correct the unsafe condition identified in the MCAI.

FAA's Determination and Requirements of the AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with this State of Design Authority, they
have notified us of the unsafe condition described in the MCAI and
service information referenced above. We are issuing this AD because we
evaluated all information provided by the State of Design Authority and
determined the unsafe condition exists and is likely to exist or
develop on other products of the same type design.

FAA's Determination of the Effective Date

    An unsafe condition exists that requires the immediate adoption of
this AD. The FAA has found that the risk to the flying public justifies
waiving notice and comment prior to adoption of this rule because
corrosion and cracking on the rudder trim tab actuator terminal could
cause the terminal to fail and result in loss of control. Since this
condition may exist in other airplanes of the same type and affects
flight safety, an immediate corrective action is required. Therefore,
we determined that notice and opportunity for public comment before
issuing this AD are impracticable and that good cause exists for making
this amendment effective in fewer than 30 days.

Comments Invited

    This AD is a final rule that involves requirements affecting flight
safety, and we did not precede it by notice and opportunity for public
comment. We invite you to send any written relevant data, views, or
arguments about this AD. Send your comments to an address listed under
the ADDRESSES section. Include ``Docket No. FAA-2014-0740; Directorate
Identifier 2014-CE-030-AD'' at the beginning of your comments. We
specifically invite comments on the overall regulatory, economic,

environmental, and energy aspects of this AD. We will consider all
comments received by the closing date and may amend this 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 AD.

Costs of Compliance

    We estimate that this AD will affect 21 products of U.S. registry.
We also estimate that it would take about 4.5 work-hours per product to
comply with the basic requirements of this AD. The average labor rate
is $85 per work-hour. Required parts would cost about $50 per product.
    Based on these figures, we estimate the cost of the AD on U.S.
operators to be $9,082.50, or $432.50 per product.
    In addition, we estimate that any necessary follow-on actions would
take about 3 work-hours and require parts costing $485, for a cost of
$740 per product. We have no way of determining the number of products
that may need these actions.

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 AD will not have federalism implications
under Executive Order 13132. This AD will not have a substantial direct
effect on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.
    For the reasons discussed above, I certify that this AD:
    (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, 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.

Adoption of the Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new AD:

2014-20-05 Empresa Brasileira de Aeronautica S. A. (EMBRAER):
Amendment 39-17978; Docket No. FAA-2014-0740; Directorate Identifier
2014-CE-030-AD.

(a) Effective Date

    This airworthiness directive (AD) becomes effective October 27,
2014.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Empresa Brasileira de Aeronautica S. A.
(EMBRAER) Models EMB-110P1 and EMB-110P2 airplanes, all serial
numbers, certificated in any category.

(d) Subject

    Air Transport Association of America (ATA) Code 27: Flight
Controls.

(e) Reason

    This AD was prompted by mandatory continuing airworthiness
information (MCAI) issued by the aviation authority of another
country to identify and correct an unsafe condition on an aviation
product. The MCAI describes the unsafe condition as corrosion and
cracking on the rudder trim tab actuator terminal. We are issuing
this AD to detect and correct corrosion and cracking on the rudder
trim tab actuator terminal, which could cause the terminal to fail
and result in loss of control.

(f) Actions and Compliance

    Unless already done, do the actions in paragraphs (f)(1) through
(f)(2) of this AD:
    (1) Within the next 10 hours time-in-service (TIS) after October
27, 2014 (the effective date of this AD) or 15 days after October
27, 2014 (the effective date of this AD), whichever occurs first,
and repetitively thereafter at intervals not to exceed 60 months, do
a detailed inspection to detect discrepancies and corrosion on the
rudder trim tab actuator components. Follow the Accomplishment
Instructions of Embraer Alert Service Bulletin (ASB) 110-27-A095,
original issue, dated August 21, 2014.
    (2) If any discrepancy is found during any inspection required
in paragraph (f)(1) of this AD, before further flight, repair or
replace the discrepancy, as necessary, following Accomplishment
Instructions of Embraer Alert Service Bulletin (ASB) 110-27-A095,
original issue, dated August 21, 2014.

(g) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
Standards Office, FAA, has the authority to approve AMOCs for this
AD, if requested using the procedures found in 14 CFR 39.19. Send
information to ATTN: Jim Rutherford, Aerospace Engineer, FAA, Small
Airplane Directorate, 901 Locust, Room 301, Kansas City, Missouri
64106; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>Before using any approved AMOC on any
airplane to which the AMOC applies, notify your appropriate
principal inspector (PI) in the FAA Flight Standards District Office
(FSDO), or lacking a PI, your local FSDO.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.
    (3) Reporting Requirements: For any reporting requirement in
this AD, a federal agency may not conduct or sponsor, and a person
is not required to respond to, nor shall a person be subject to a
penalty for failure to comply with a collection of information
subject to the requirements of the Paperwork Reduction Act unless
that collection of information displays a current valid OMB Control
Number. The OMB Control Number for this information collection is
2120-0056. Public reporting for this collection of information is
estimated to be approximately 5 minutes per response, including the
time for reviewing instructions, completing and reviewing the
collection of information. All responses to this collection of
information are mandatory. Comments concerning the accuracy of this
burden and suggestions for reducing the burden should be directed to
the FAA at: 800 Independence Ave. SW., Washington, DC 20591, Attn:
Information Collection Clearance Officer, AES-200.

(h) Related Information

    Refer to MCAI Ag[ecirc]ncia Nacional de Avia[ccedil][atilde]o
Civil (ANAC) AD No.: 2014-09-01, dated September 4, 2014, for
related information. You may examine the MCAI on the Internet at
http://www.regulations.gov by searching for and locating Docket No.
FAA-2014-0740.

(i) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) EMBRAER Alert Service Bulletin SB No.: 110-27-A095, dated
August 21, 2014.
    (ii) Reserved.
    (3) For Empresa Brasileira de Aeronautica S. A. (EMBRAER)
service information identified in this AD, contact Embraer-S.A.,
EFTC-Service Bulletin Engineering, Avenida Brigadeiro Faria Lima,
2170, S[atilde]o Jos[eacute] dos Campos-SP-12227-901, Brasil; phone:
+55 12 3927 1000; fax: +55 12 3927-6600 (ext. 1624); email:
<EMAIL_ADDRESS>internet: http://www.flyembraer.com.
    (4) You may view this service information at the FAA, Small
Airplane Directorate, 901 Locust, Kansas City, Missouri 64106. For
information on the availability of this material at the FAA, call
(816) 329-4148.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Kansas City, Missouri on September 24, 2014.
Monica L. Nemecek,
Acting Manager, Small Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2014-23555 Filed 10-6-14; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 76, Number 156 (Friday, August 12, 2011)]
[Notices]
[Pages 50230-50231]
[FR Doc No: 2011-20575]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0556]

Center for Devices and Radiological Health 510(k) Clearance
Process; Recommendations Proposed in Institute of Medicine Report:
``Medical Devices and the Public's Health, The FDA 510(k) Clearance
Process at 35 Years;'' Public Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing a public
meeting entitled: ``Recommendations Proposed in Institute of Medicine
Report: `Medical Devices and the Public's Health, The FDA 510(k)
Clearance Process at 35 Years.' '' The purpose of the public meeting is
to encourage public comment on the recommendations proposed in the
Institute of Medicine (IOM) report.
    Date and Time: The public meeting will be held on September 16,
2011, from 8:30 a.m. to 5 p.m. Submit electronic and written comments
by September 30, 2011.
    Location: The public meeting will be held at the Silver Spring
Hilton Hotel, 8727 Colesville Rd., Silver Spring, MD 20910.
    Contact Person: Philip Desjardins, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 5452, Silver Spring, MD 20993,<PHONE_NUMBER>,
<EMAIL_ADDRESS>    Registration and Requests for Oral Presentations: Registration is
free and will be on a first-come, first-served basis. Persons
interested in attending this meeting must register online by 5 p.m. on
September 15, 2011. For those without Internet access, please call the
contact person to register.
    Early registration is recommended because seating is limited and,
therefore, FDA may limit the number of participants from each
organization. If time and space permit, onsite registration on the day
of the public meeting will be provided beginning at 7:30 a.m.
    If you need special accommodations due to a disability, please
contact Susan Monahan (email<EMAIL_ADDRESS>or phone: 301-
796-5661) no later than September 15, 2011.
    To register for the public meeting, please visit http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm
(or go to the FDA Medical Devices News & Events--Workshops &
Conferences calendar and select this public meeting from the posted
events list). Please provide complete contact information for each
attendee, including name, title, affiliation, address, email,
telephone, and FAX number. Registrants will receive confirmation once
they have been accepted. You will be notified if you are on a waitlist.
    This meeting includes a public comment session. During online
registration you may indicate if you wish to make an oral presentation
during a public comment session at the public meeting, and which topic
you wish to address in your presentation. FDA has included topics for
comment in this document. FDA will do its best to accommodate requests
to speak. Individuals and organizations with common interests are urged
to consolidate or coordinate their presentations, and request time for
a joint presentation. FDA will determine the amount of time allotted to
each presenter and the approximate time each oral presentation is to
begin. All requests to make oral presentations, as well as presentation
materials, must be sent to the contact person by September 15, 2011.
    Comments: Regardless of attendance at the public meeting,
interested persons may submit either electronic or written comments
until September 30, 2011. Submit electronic comments to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. It is only necessary to send one set of
comments. It is no longer necessary to send two copies of mailed
comments. Identify comments with the docket number found in brackets in
the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.

SUPPLEMENTARY INFORMATION:

I. What is the background and purpose for holding this public meeting?

    In September 2009, FDA's Center for Devices and Radiological Health
(CDRH) convened an internal 510(k) Working Group as part of a two-
pronged, comprehensive assessment of the premarket notification
(510(k)) process. The first prong of this evaluation consisted of an
internal evaluation of the 510(k) process, resulting in the publication
of the CDRH preliminary internal evaluation entitled ``510(k) Working
Group Preliminary Report and Recommendations'' (http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDRH/CDRHReports/UCM220784.pdf ).
This preliminary report was intended to communicate preliminary
findings and recommendations regarding the 510(k) program and actions
CDRH might take to address identified areas of concern. The report was
issued on August 5, 2010 (75 FR 47307). After reviewing public comment,
CDRH issued a plan of action for implementation of the previously
announced

recommendations on January 19, 2011 (http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDRH/CDRHReports/UCM239450.pdf ).
    The second prong of the comprehensive assessment of the 510(k)
process was an independent study by the IOM. At the request of FDA, IOM
evaluated the 510(k) clearance process and made recommendations aimed
at protecting the health of the public and making available a mechanism
to achieve timely access of medical devices to the market. On July 29,
2011, IOM released the report ``Medical Devices and the Public's
Health, The FDA 510(k) Clearance Process at 35 Years'' (report) (http://www.iom.edu/Reports/2011/Medical-Devices-and-the-Publics-Health-The-FDA-510k-Clearance-Process-at-35-Years.aspx). The report contains eight
recommendations aimed at improving regulation of medical devices. The
recommendations are the subject of this public meeting.

II. What are the specific issues for discussion and public comment at
the public meeting?

    FDA welcomes comments on the following recommendations provided in
the IOM report:
    1. The Food and Drug Administration should obtain adequate
information to inform the design of a new medical device regulatory
framework for class II devices so that the current 510(k) process, in
which the standard for clearance is substantial equivalence to
previously cleared devices, can be replaced with an integrated
premarket and postmarket regulatory framework that effectively provides
a reasonable assurance of safety and effectiveness throughout the
device life cycle. Once adequate information is available to design an
appropriate medical device regulatory framework, Congress should enact
legislation to do so.
    2. FDA should develop and implement a comprehensive strategy to
collect, analyze, and act on medical device postmarket performance
information.
    3. FDA should review its postmarket regulatory authorities for
medical devices to identify existing limitations on their use and to
determine how the limitations can be addressed.
    4. FDA should investigate the viability of a modified de novo
process as a mechanism for evaluating the safety and effectiveness of
class II devices.
    5. FDA should develop and implement a program of continuous quality
improvement to track regulatory decisions on medical devices, identify
potential process improvements in the medical device regulatory
framework, and address emerging issues that affect decisionmaking.
    6. FDA should commission an assessment to determine the effect of
its regulatory process for class II devices on facilitating or
inhibiting innovation in the medical device industry.
    7. FDA should develop procedures that ensure the safety and
effectiveness of software used in devices, software used as devices,
and software used as a tool in producing devices.
    8. FDA should promptly call for PMA applications for or reclassify
class III devices that remain eligible for 510(k) clearance.

III. Where can I find out more about this public meeting?

    Background information on the public meeting, registration
information, the agenda, information about lodging, transcripts, and
other relevant information will be posted, as it becomes available, on
the Internet at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm.

IV. Will there be transcripts of the meeting?

    Please be advised that as soon as a transcript is available, it
will be accessible at http://www.regulations.gov. It may be viewed at
the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. A
transcript will also be available in either hardcopy or on CD-ROM,
after submission of a Freedom of Information request. Written requests
are to be sent to Division of Freedom of Information (HFI-35), Office
of Management Programs, Food and Drug Administration, 5600 Fishers
Lane, rm. 6-30, Rockville, MD 20857.

    Dated: August 9, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2011-20575 Filed 8-11-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 77, Number 241 (Friday, December 14, 2012)]
[Notices]
[Page 74520]
[FR Doc No: 2012-30301]

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SECURITIES AND EXCHANGE COMMISSION

[File No. 500-1]

In the Matter of the Hartcourt Companies, Inc., Hawksdale
Financial Visions, Inc. (n/k/a Advanced Medical Institute, Inc.),
Healthcare Providers Direct, Inc., Heartland Oil & Gas Corp., Hellenic
Solutions Corp., and HIV-VAC, Inc. (n/k/a Grupo International, Inc.);
Order of Suspension of Trading

December 12, 2012.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
The Hartcourt Companies, Inc. because it has not filed any periodic
reports since the period ended November 30, 2009.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Hawksdale Financial Visions, Inc. (n/k/a Advanced Medical Institute,
Inc.) because it has not filed any periodic reports since the period
ended December 31, 2009.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Healthcare Providers Direct, Inc. because it has not filed any periodic
reports since September 30, 2008.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Heartland Oil & Gas Corp. because it has not filed any periodic since
the period ended June 30, 2008.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Hellenic Solutions Corp. because it has not filed any periodic reports
since the period ended September 30, 2010.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
HIV-VAC, Inc. (n/k/a Grupo International, Inc.) because it has not
filed any periodic reports since the period ended December 31, 2010.
    The Commission is of the opinion that the public interest and the
protection of investors require a suspension of trading in the
securities of the above-listed companies.
    Therefore, it is ordered, pursuant to Section 12(k) of the
Securities Exchange Act of 1934, that trading in the securities of the
above-listed companies is suspended for the period from 9:30 a.m. EST
on December 12, 2012, through 11:59 p.m. EST on December 26, 2012.

    By the Commission.
Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2012-30301 Filed 12-12-12; 4:15 pm]
BILLING CODE 8011-01-P


[Federal Register Volume 77, Number 81 (Thursday, April 26, 2012)]
[Notices]
[Pages 24943-24945]
[FR Doc No: 2012-10071]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 12778-004]

Fall Creek Hydro, LLC; Notice of Application Accepted for Filing,
Soliciting Motions To Intervene and Protests, Ready for Environmental
Analysis, and Soliciting Comments, Recommendations, Preliminary Terms
and Conditions, and Preliminary Fishway Prescriptions

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection.
    a. Type of Application: Original Major License.
    b. Project No.: 12778-004.
    c. Date filed: February 28, 2011.
    d. Applicant: Fall Creek Hydro, LLC.
    e. Name of Project: Fall Creek Dam Hydroelectric Project.
    f. Location: The proposed project would be constructed at the
existing U.S. Army Corps of Engineer's (Corps) Fall Creek Dam located
on Fall Creek near the towns of Springfield and Eugene in Lane County,
Oregon. The project would occupy 6.53 acres of Federal lands managed by
the Corps.
    g. Filed Pursuant to: Federal Power Act 16 U.S.C. 791(a)-825(r).

    h. Applicant Contact: Brent L. Smith, Chief Operating Officer;
Symbiotics LLC; 371 Upper Terrace, Suite 2, Bend, OR 97702; Telephone
(541) 330-8779.
    i. FERC Contact: Lee Emery, Telephone<PHONE_NUMBER> and email
<EMAIL_ADDRESS>    j. Deadline for filing motions to intervene and protests, comments,
recommendations, preliminary terms and conditions, and preliminary
prescriptions: 60 days from the issuance date of this notice; reply
comments are due 105 days from the issuance date of this notice.
Motions to intervene, protests, comments, recommendations, preliminary
terms and conditions, and preliminary fishway prescriptions may be
filed electronically via the Internet. See 18 CFR 385.2001(a)(1)(iii)
and the instructions on the Commission's Web site http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit brief comments up to
6,000 characters, without prior registration, using the eComment system
at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your
name and contact information at the end of your comments. For
assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>or toll free at 1-866-208-3676, or for TTY,
(202) 502-8659. Although the Commission strongly encourages electronic
filing, documents may also be paper-filed. To paper-file, mail an
original and seven copies to: Kimberly D. Bose, Secretary, Federal
Energy Regulatory Commission, 888 First Street NE., Washington, DC
20426.
    The Commission's Rules of Practice require all intervenors filing
documents with the Commission to serve a copy of that document on each
person on the official service list for the project. Further, if an
intervenor files comments or documents with the Commission relating to
the merits of an issue that may affect the responsibilities of a
particular resource agency, they must also serve a copy of the document
on that resource agency.
    k. This application has been accepted for filing and is now is
ready for environmental analysis.
    l. The proposed project would utilize the existing Corps' Fall
Creek Dam and Fall Creek Reservoir, and would consist of the following
new facilities: (1) Three water inlet structures with a total capacity
of 625 cubic feet per second, built on the upstream face of the dam
drawing water from elevations 720, 765 and 800 mean sea level; (2) a
32-foot-long, 22-foot-wide valve control structure for the three water
inlets; (3) an 8-foot-diameter, approximately 570-foot-long penstock
grouted to the existing south side concrete outlet structure; (4) a 10-
foot-high, 5.5-foot-wide penstock isolation gate located at the
downstream end of the penstock and maintaining hydraulic pressure in
the penstock; (5) two 8-foot-diameter bifurcations located
approximately 70 feet upstream of the penstock isolation gate; (6) two
110-foot-long, 8-foot-diameter penstocks; (7) two Eicher screens, one
per penstock; (8) a 48.5-foot-long, 44-foot-wide concrete fish screen
enclosure; (9) a 26-foot-long penstock convergence and trifurcation
section leading to two Francis and one Kaplan turbine-generating units
with a total installed capacity of 10 megawatts (MW); (10) a 75-foot-
long, 60-foot-wide concrete powerhouse; (11) a network of pipes
supplying water to an existing Corps fish collection facility during
powerhouse operation or shutdown; (12) an approximately 100-foot-long,
64-foot-wide concrete tailrace channel equipped with picket barrier to
prevent fish from accessing the turbine runners; (13) a 2,850-foot-long
fish bypass system starting at the Eicher screens and consisting of (a)
two 1,430-foot-long by 24-inch-diameter pipes each with 24 outlets
discharging into an approximately 1,420-foot-long, 24-inch-wide and 24-
inch-deep ``U'' shaped concrete open channel return chute; and (b) an
approximately 33-foot-long, 23-foot-wide fish evaluation station
located approximately 370 feet upstream from where the return chute
discharges back into Fall Creek; (14) a 442-foot-long, 12.5 kilovolt
buried transmission line connecting the powerhouse to an existing
overhead transmission line which is part of the local grid; and (15)
appurtenant facilities. The project would occupy 6.53 acres of Federal
lands owned and managed by the Corps. The average annual generation is
estimated to be 21,220 megawatt-hours.
    m. A copy of the application is available for review at the
Commission in the Public Reference Room or may be viewed on the
Commission's Web site at http://www.ferc.gov using the ``eLibrary''
link. Enter the docket number excluding the last three digits in the
docket number field to access the document. For assistance, contact
FERC Online Support. A copy is also available for inspection and
reproduction at the address in item h above.
    Register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filings and issuances
related to this or other pending projects. For assistance, contact FERC
Online Support.
    n. Anyone may submit comments, a protest, or a motion to intervene
in accordance with the requirements of Rules of Practice and Procedure,
18 CFR 385.210, .211, .and 214. In determining the appropriate action
to take, the Commission will consider all protests or other comments
filed, but only those who file a motion to intervene in accordance with
the Commission's Rules may become a party to the proceeding. Any
comments, protests, or motions to intervene must be received on or
before the specified comment date for the particular application.
    All filings must (1) bear in all capital letters the title
``PROTEST,'' ``MOTION TO INTERVENE,'' ``COMMENTS,'' ``REPLY COMMENTS,''
``RECOMMENDATIONS,'' ``PRELIMINARY TERMS AND CONDITIONS,'' or
``PRELIMINARY FISHWAY PRESCRIPTIONS;'' (2) set forth in the heading the
name of the applicant and the project number of the application to
which the filing responds; (3) furnish the name, address, and telephone
number of the person protesting or intervening; and (4) otherwise
comply with the requirements of 18 CFR 385.2001 through 385.2005. All
comments, recommendations, terms and conditions or prescriptions must
set forth their evidentiary basis and otherwise comply with the
requirements of 18 CFR 4.34(b). Agencies may obtain copies of the
application directly from the applicant. A copy of any protest or
motion to intervene must be served upon each representative of the
applicant specified in the particular application. A copy of all other
filings in reference to this application must be accompanied by proof
of service on all persons listed in the service list prepared by the
Commission in this proceeding, in accordance with 18 CFR 4.34(b) and
385.2010.
    o. Procedural Schedule:
    The application will be processed according to the following
revised Hydro Licensing Schedule. Revisions to the schedule may be made
as appropriate.

------------------------------------------------------------------------
               Milestone                           Target date
------------------------------------------------------------------------
Filing of recommendations, preliminary   June 2012.
 terms and conditions, and preliminary
 fishway prescriptions.
Commission issues Draft EA.............  December 2012.

Comments on Draft EA...................  January 2013.
Modified Terms and Conditions..........  March 2013.
Commission Issues Final EA.............  June 2013.
------------------------------------------------------------------------

    p. Final amendments to the application must be filed with the
Commission no later than 30 days from the issuance date of this notice.
    q. A license applicant must file no later than 60 days following
the date of issuance of the notice of acceptance and ready for
environmental analysis provided for in 5.22: (1) A copy of the water
quality certification; (2) a copy of the request for certification,
including proof of the date on which the certifying agency received the
request; or (3) evidence of waiver of water quality certification.
    r. Any qualified applicant desiring to file a competing application
must submit to the Commission, on or before the specified intervention
deadline date, a competing development application, or a notice of
intent to file such an application. Submission of a timely notice of
intent allows an interested person to file the competing development
application no later than 120 days after the specified intervention
deadline date. Applications for preliminary permits will not be
accepted in response to this notice.
    A notice of intent must specify the exact name, business address,
and telephone number of the prospective applicant, and must include an
unequivocal statement of intent to submit a development application. A
notice of intent must be served on the applicant(s) named in this
public notice.

    Dated: April 19, 2012.
Kimberly D. Bose,
 Secretary .
[FR Doc. 2012-10071 Filed 4-25-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 158 (Tuesday, August 16, 2016)]
[Rules and Regulations]
[Pages 54499-54501]
[FR Doc No: 2016-19492]

=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 11 and 101

[Docket No. FDA-2011-F-0171]

Calorie Labeling of Articles of Food in Vending Machines:
Guidance for Industry; Small Entity Compliance Guide; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of availability.

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

SUMMARY: The Food and Drug Administration (FDA or we) is announcing the
availability of a guidance for industry entitled ``Calorie Labeling of
Articles of Food in Vending Machines--Small Entity Compliance Guide.''
The small entity compliance guide (SECG) is intended to help small
entities comply with the final rule entitled ``Food Labeling; Calorie
Labeling of Articles of Food in Vending Machines.''

DATES: Submit either electronic or written comments on FDA guidances at
any time.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, 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-2011-F-0171 for ``Calorie Labeling of Articles of Food in Vending
Machines--Small Entity Compliance Guide.'' Received comments will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at http://www.regulations.gov or at
the Division of Dockets Management 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 http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the guidance to the
Office of Nutrition and Food Labeling, Food Labeling and Standards
Staff, Center for Food Safety and Applied Nutrition (HFS-305), Food and
Drug Administration, 5001 Campus Dr., College Park, MD 20740. Send two
self-addressed adhesive labels to assist that office in processing your
request. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance.

FOR FURTHER INFORMATION CONTACT: Ashley N. Rulffes, Center for Food
Safety and Applied Nutrition (HFS-820), Food and Drug Administration,
5001 Campus Dr., College Park, MD 20740,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of December 1, 2014 (79 FR 71259), we
issued a final rule requiring vending machine operators who own or
operate 20 or more vending machines, or who voluntarily register to be
covered, to provide calorie declarations for those foods sold from
vending machines for which the Nutrition Facts label cannot be examined
before purchase or for which visible nutrition information is not
otherwise provided at the point of purchase (the final rule). Covered
vending machine operators must comply with the rule by December 1,
2016. However, in the Federal Register of August 1, 2016 (81 FR 50303),
we issued a final rule entitled ``Food Labeling; Calorie Labeling of
Articles of Food in Vending Machines; Extension of Compliance Date.''
This rule provides that the compliance date for type size front-of-pack
labeling requirements (Sec.  101.8(b)(2) (21 CFR 101.8(b)(2))) and
calorie disclosure requirements (Sec.  101.8(c)(2)) for certain gums,
mints, and roll candy products in glass-front machines in the final
rule published December 1, 2014 (79 FR 71259) is extended to July 26,
2018. The compliance date for all other requirements in the final rule
(79 FR 71259) remains December 1, 2016.
    We examined the economic implications of the final rule as required
by the Regulatory Flexibility Act (5 U.S.C. 601-612) and determined
that the final rule will have a significant economic impact on a
substantial number of small entities. In compliance with section 212 of
the Small Business Regulatory Enforcement Fairness Act (Pub. L. 104-
121, as amended by Pub. L. 110-28), we are making available the SECG to
explain the actions that a small entity must take to comply with the
rule.
    We are issuing the SECG consistent with our good guidance practices
regulation (21 CFR 10.115(c)(2)). The SECG represents our current
thinking on calorie labeling for foods sold in vending machines
operated by a person engaged in the business of owning or operating 20
or more vending machines, or a person who voluntarily registers with
FDA to be covered by the rule. It does not create or confer any rights
for or on any person and does not operate to bind FDA or the public. An
alternative approach may be used if such approach satisfies the
requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    This SECG refers to collections of information described in FDA's
final rule that published in the Federal Register of December 1, 2014,
and that will be effective on December 1, 2016. As stated in the final
rule, these collections of information are subject to review by the
Office of Management and Budget (OMB) under the Paperwork Reduction Act
of 1995 (the PRA) (44 U.S.C. 3501-3520). The collections of information
in the final rule have been approved under OMB control number 0910-
0782. An Agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information unless it displays
a currently valid OMB control number.

III. Electronic Access

    Persons with access to the Internet may obtain the SECG at either
http://www.fda.gov/Food/GuidanceRegulation/

GuidanceDocumentsRegulatoryInformation/default.htm or http://www.regulations.gov. Use the FDA Web site listed in the previous
sentence to find the most current version of the guidance.

    Dated: August 11, 2016.
Jeremy Sharp,
Deputy Commissioner for Policy, Planning, Legislation and Analysis.
[FR Doc. 2016-19492 Filed 8-15-16; 8:45 am]
 BILLING CODE 4164-01-P