[Federal Register: December 1, 2009 (Volume 229, Number 74)]
[Notices]
[Page 62845]
[DOCID:fr01de09-134]

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SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request

Upon Written Request; Copies Available From: Securities and Exchange
Commission, Office of Investor Education and Advocacy, Washington, DC
20549-0213.

Extension:
    Rule 13e-1, OMB Control No. 3235-0305, SEC File No. 270-255

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') is soliciting comments on the collection of
information summarized below. The Commission plans to submit this
existing collection of information to the Office of Management and
Budget for extension and approval.
    Rule 13e-1 (17 CFR 240.13e-1) makes it unlawful for an issuer who
has received notice that it is the subject of a tender offer made under
Section 14(d)(1) of the Securities Exchange Act of 1934 (15 U.S.C.
78n(d)(1)) to purchase any of its equity securities during the tender
offer, unless it first files a statement with the Commission containing
information require by the Rule. This rule is in keeping with the
Commission's statutory responsibility to prescribe rules and
regulations that are necessary for the protection of investors. The
information filed under Rule 13e-1 must be filed with the Commission
and is publicly available. We estimate that it takes approximately 10
burden hours per response to provide the information required under
Rule 13e-1 and that the information is filed by approximately 20
respondents. We estimate that 25% of the 10 hours per response (2.5
hours) is prepared by the company for a total annual reporting burden
of 50 hours (2.5 hours per response x 20 responses).
    Written comments are invited on: (a) Whether this proposed
collection of information is necessary for the performance of the
functions of the agency, including whether the information will have
practical utility; (b) the accuracy of the agency's estimate of the
burden imposed by the collection of information; (c) ways to enhance
the quality, utility, and clarity of the information collected; and (d)
ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques or other forms of information technology. Consideration will
be given to comments and suggestions submitted in writing within 60
days of this publication.
    Please direct your written comment to Charles Boucher, Director/
CIO, Securities and Exchange Commission, C/O Shirley Martinson, 6432
General Green Way, Alexandria, Virginia 22312; or send an e-mail to:
<EMAIL_ADDRESS>
    Dated: November 24, 2009.
Elizabeth M. Murphy,
Secretary.
[FR Doc. E9-28689 Filed 11-30-09; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register Volume 82, Number 49 (Wednesday, March 15, 2017)]
[Notices]
[Pages 13819-13820]
[FR Doc No: 2017-05102]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-0154]

Considerations in Demonstrating Interchangeability With a
Reference Product; Draft Guidance for Industry; Availability; Extension
of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability; extension of comment period.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
extending the comment period for the notice that appeared in the
Federal Register of January 18, 2017. In the notice, FDA requested
comments on ``Considerations in Demonstrating Interchangeability with a
Reference Product.'' The Agency is taking this action in response to
several requests for an extension to allow interested persons
additional time to submit comments.

DATES: FDA is extending the comment period on the notice published
January 18, 2017 (82 FR 5579). Submit either electronic or written
comments by May 19, 2017. Late, untimely filed comments will not be
considered. Electronic comments must be submitted on or before May 19,
2017. The https://www.regulations.gov electronic filing system will
accept comments until midnight Eastern Time at the end of May 19, 2017.
Comments received by mail/hand delivery/courier (for written/paper
submissions) will be considered timely if they are postmarked or the
delivery service acceptance receipt is on or before that date.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): 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-2017-D-0154 for ``Considerations in Demonstrating
Interchangeability With a Reference Product; Draft Guidance for
Industry.'' Received comments, those filed in a timely manner (see
DATES), will be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://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 https://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: https://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 https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Sandra Benton, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6340, Silver Spring, MD 20993-0002, 301-
796-1042, or Stephen Ripley, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm. 7301, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In the Federal Register of January 18, 2017
(82 FR 5579), FDA published a notice with a 60-day comment period to
request comments on ``Considerations in Demonstrating
Interchangeability With a Reference Product.''
    The Agency has received several requests for a 60-day extension of
the comment period for the notice. The requests conveyed concern that
the current 60-day comment period does not allow sufficient time to
develop a meaningful or thoughtful response to the notice.
    FDA has considered the requests and is extending the comment period
for the notice for 60 days, until May 19, 2017. The Agency believes
that a 60-day extension allows adequate time for interested persons to
submit comments without significantly delaying rulemaking on these
important issues.

    Dated: March 9, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-05102 Filed 3-14-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 78, Number 179 (Monday, September 16, 2013)]
[Notices]
[Pages 56957-56960]
[FR Doc No: 2013-22403]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-70363; File No. SR-EDGX-2013-33]

Self-Regulatory Organizations; EDGX Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change Relating to
Amendments to the EDGX Exchange, Inc. Fee Schedule

September 10, 2013.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on August 30, 2013, EDGX Exchange, Inc. (the ``Exchange'' or
``EDGX'') 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 self-regulatory
organization. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 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 its Fee Schedule to: (i) add the
Tape B Step Up Tier; (ii) add the Mega Tier 3; (iii) move the bullets
related to ``added flags,'' ``removal flags,'' and ``routed flags''
from the Definitions section to the General Notes section; and (iv)
amend the phrase ``Step Up'' to ``Step-Up'' in the tiers in Footnote 1.
All of the changes described herein are applicable to EDGX Members.\3\
The text of the proposed rule change is available on the Exchange's
Internet Web site at www.directedge.com, at the Exchange's principal
office, and at the Public Reference Room of the Commission.
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    \3\ As defined in Exchange Rule 1.5(n).
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II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the self-regulatory organization
included statements concerning the purpose of, and basis for, the
proposed rule change 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 self-regulatory organization
has prepared summaries, set forth in sections A, B and C below, of the
most significant aspects of such statements.

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

1. Purpose
    The Exchange proposes to amend its Fee Schedule to: (i) add the
Tape B Step Up Tier; (ii) add the Mega Tier 3; (iii) move the bullets
related to ``added flags,'' ``removal flags,'' and ``routed flags''
from the Definitions section to the General Notes section; and (iv)
amend the phrase ``Step Up'' to ``Step-Up'' in the tiers in Footnote 1.
Addition of Tape B Step Up Tier
    The Exchange proposes to add a new tier to its Fee Schedule, the
Tape B Step Up Tier. The Tape B Step Up Tier would provide a rebate of
$0.0025 per share for orders yielding flags B and 4 (adds liquidity to
EDGX in Tape B securities) to Members that add 600,000 shares in
average daily volume (``ADV'') in Tape B securities more than the
Member's August 2013 ADV in Tape B securities added to EDGX. The
Exchange proposes to remove the word ``Reserved'' from Footnote 2 to
its Fee Schedule and replace it with the Tape B Step Up Tier.
Furthermore, the Exchange proposes to append Footnote 2 to flags B and
4, both of which would qualify for the tiered rebate if a Member meets
the aforementioned requirement.
Addition of the Mega Tier 3
    The Exchange proposes to add a new tier to its Fee Schedule, the
Mega Tier 3. The Mega Tier 3 would provide a rebate of $0.0032 per
share for orders that add liquidity yielding flags B, V, Y, 3, 4 and ZA
provided the Member (i) adds or routes at least 1,500,000 shares of ADV
prior to 9:30 a.m. or after 4:00 p.m. and (ii) adds a minimum of 0.75%
of the total consolidated volume (``TCV'') on a daily basis measured
monthly, including during both market hours and pre- and post-trading
hours. The Exchange proposes to add the Mega Tier 3 below Mega Tier 2
and above the Market Depth Tier within the list of volume tiers in
Footnote 1 to its Fee Schedule.
Amendments to Lists of Added, Removal and Routed Flags
    Currently, the Definitions section in the Fee Schedule contains
three bullets that contain the list of applicable ``added flags,''
``removal flags,'' and ``routed flags,'' that may be considered when
calculating whether a Member satisfied a certain tier. The Exchange
proposes to move the text contained within each of the three bullets to
the General Notes section. In addition, the Exchange proposes to re-
word the text of each bullet to improve readability and remove
references to the flags as defined terms. For example, the amended
bullet regarding added flags would read as follows: ``Unless otherwise
indicated, the following added flags are counted towards tiers . . .''
The Exchange notes that the list of added/removal/routed flags
associated with each bullet would remain unchanged.
Amendment to Step-Up Tiers in Footnote 1
    Currently, the Step-Up Tiers in Footnote 1 to the Fee Schedule are
lacking a hyphen between the words ``Step'' and ``Up.'' The Exchange
proposes to add a hyphen so that each tier so-titled would no longer be
a ``Step Up'' tier but a ``Step-Up'' tier. The Exchange notes that the
criteria necessary to achieve the tiers and the rates offered by the
tiers would remain unchanged.
Implementation Date
    The Exchange proposes to implement these amendments to its Fee
Schedule on September 3, 2013.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the objectives of Section 6 of the Act,\4\ in general, and
furthers the objectives of Section 6(b)(4),\5\ in particular, as it is
designed to provide for the equitable allocation of reasonable dues,
fees and other charges among its Members and other persons using its
facilities.
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    \4\ 15 U.S.C. 78f.
    \5\ 15 U.S.C. 78f(b)(4).

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Addition of Tape B Step Up Tier
    The Exchange believes that its proposal to add the Tape B Step Up
Tier to Footnote 2 to its Fee Schedule represents an equitable
allocation of reasonable dues, fees, and other charges among Members
and other persons using its facilities because the tier would encourage
Members to add liquidity to EDGX in Tape B securities in order to
qualify for a higher rebate. The Exchange currently offers a rebate of
$0.0020 per share for orders that add liquidity to EDGX in Tape B
securities yielding flags B (regular session) and 4 (pre and post
market). The Tape B Step Up Tier would provide Members with an
increased rebate of $0.0025 per share for orders that yield flags B and
4, provided Members meet the increased volume requirement necessary to
achieve the tier. As such, the Exchange believes that the rate offered
by the Tape B Step Up Tier is reasonable because it is directly related
to a Member's level of executions in Tape B Securities during the
month.
    The Exchange also notes that the Tape B Step Up Tier is similar to
the Step-Up Tier 1 in Tape B securities offered by NYSE Arca, Inc.
(``Arca'').\6\ Arca currently offers a non-tiered rebate for adding
liquidity in Tape B securities of $0.22 per share and a non-tiered fee
for removing liquidity in Tape B securities of $0.30 per share. Arca's
Step-Up Tier 1 provides for an add rebate of $0.23 per share and a
removal fee of $0.28 for firms that add an excess of 0.20% in ADV in
Tape B securities over a benchmark month, subject to a minimum increase
of 20 million shares. The Tape B Step Up Tier is similar to the Arca's
Step-Up Tier 1 in that it provides Members with an increased rebate in
exchange for increased volume.
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    \6\ Arca, NYSE Arca Equities Trading Fees, available at http://usequities.nyx.com/markets/nyse-arca-equities/trading-fees.
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    Lastly, The Exchange believes that the proposed rate is non-
discriminatory in that it applies uniformly to all Members.
Addition of the Mega Tier 3
    The Exchange believes that its proposal to add the Mega Tier 3 to
the list of volume tiers in Footnote 1 to its Fee Schedule represents
an equitable allocation of reasonable dues, fees, and other charges
among Members and other persons using its facilities because the tier
would encourage Members to add liquidity to EDGX during pre- and post-
trading hours. Fewer Members generally trade during pre- and post-
trading hours because of the limited time parameters associated with
these trading sessions, which generally results in less liquidity. In
addition, the Exchange assigns a higher value to this resting liquidity
because liquidity received prior to the regular trading session
typically remains resident on the EDGX Book throughout the remainder of
the entire trading day. Furthermore, liquidity received during pre- and
post-trading hours is an important contributor to price discovery and
acts as an important indication of price for the market as a whole
considering the relative illiquidity of the pre- and post-trading hour
sessions. The Exchange believes that offering a higher rebate
incentivizes Members to provide liquidity during these trading
sessions.
    The Exchange also believes that the Mega Tier 3 is reasonable and
equitably allocated because such increased liquidity benefits all
investors by deepening EDGX's liquidity pool and improving investor
protection. Volume-based rebates such as the one proposed herein are
widely utilized in the cash equities markets, and are equitable because
they are open to all Members on an equal basis and provide incentives
that are reasonably related to the value to an exchange's market
quality associated with higher levels of market activity, such as
higher levels of liquidity provision and opportunities for price
improvement.
    Furthermore, the Exchange believes that the criteria for the Mega
Tier 3 represents an equitable allocation of reasonable dues, fees, and
other charges because higher rebates are directly correlated with more
stringent criteria.
    For example, in order for a Member to qualify for the Mega Tier 1
and be provided with a rebate of $0.0035 and a $ 0.0015 discounted
routing and removal rate, the Member would have to (i) add or route at
least 4,000,000 shares of ADV during pre- and post-trading hours (ii)
add a minimum of 35,000,000 shares of ADV on EDGX in total, including
during both market hours and pre- and post-trading hours and (iii) have
an ``added liquidity'' to ``added plus removed liquidity'' ratio of at
least 85%. When comparing the first criteria of the Mega Tier 1 to that
of the Mega Tier 3, it is apparent that the Mega Tier 1 requires a
volume requirement during pre- and post-trading hours that is 2,500,000
shares higher than that required by the Mega Tier 3, which only
requires 1,500,000 shares of ADV during pre- and post-trading hours.
With regard to the second criteria of both tiers, based on a TCV for
September 2013 of six (6) billion shares, a Member would be required to
add 40,000,000 shares in ADV on EDGX in total, including both market
hours and pre- and post-trading hours to meet the second criteria to
achieve the Mega Tier 3, which is higher than the 35,000,000 shares
required to meet the second criteria under the Mega Tier 1. Although
the ADV required under the second criteria of the Mega Tier 3 is higher
than that required by the Mega Tier 1, the Mega Tier 1 contains yet a
third criteria not required of the Mega Tier 3--that a Member have an
``added liquidity'' to ``added plus removed liquidity'' ratio of at
least 85%. Members that primarily post liquidity are more valuable
Members to the Exchange and the marketplace in terms of liquidity
provision. Therefore, the Exchange offers a higher rebate to those
Members that are able to meet the ``added liquidity'' to ``added plus
removed liquidity'' ratio of 85% under the third criteria of the Mega
Tier 1. Accordingly, the Mega Tier 1 is the most stringent of the
volume tiers and provides the highest rebate.
    In order to qualify for the next best tier, the Market Depth Tier,
and receive a rebate of $0.0033 per share for displayed liquidity, a
Member must post at least 0.50% of the TCV in ADV on EDGX in total,
where at least 1.8 million shares are non-displayed orders that add
liquidity to EDGX yielding Flag HA. Based on a TCV for May 2013 of six
(6) billion shares, this would amount to 30,000,000 shares for the
Market Depth Tier and 45,000,000 shares for the Mega Tier 3. While the
Mega Tier 3's TCV requirement is higher, Members seeking to achieve the
Market Depth Tier would also be required to post at least 1.8 million
shares are non-displayed orders that add liquidity to EDGX yielding
Flag HA. The Exchange believes that this requirement regarding non-
displayed liquidity is more stringent and warrants a higher rebate
because non-displayed orders do not have the same ability to attract
contra-side orders to the marketplace because they are hidden on the
EDGX book, are less commonplace than displayed liquidity, and Members
are not eligible for the same rebates that displayed liquidity qualify
for.\7\ In addition, because of the hierarchy of priority in Rule
11.8(a)(2), for equally priced trading interest, non-displayed orders
always have a lower priority than displayed orders. As a result, a
Member has a priority disadvantage when using such order type and
therefore, the criteria to satisfy the Market Depth Tier are more
stringent than those of the Mega Tier 3 and warrant a higher rebate.
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    \7\ Non-displayed orders that add liquidity (Flag HA) are
eligible for a $0.0015 per share rebate instead of the standard
rebate for displayed liquidity of $0.0020 per share.
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    Mega Tier 3 provides the same rebate as Mega Tier 2. To achieve the
Mega

Tier 2 and receive a rebate of $0.0032 per share, a Member must (1) add
or route at least 4,000,000 shares of ADV prior to 9:30 a.m. or after
4:00 p.m. (includes all flags except 6); and (2) add a minimum of 0.20%
of the TCV on a daily basis measured monthly, including during both
market hours and pre and post-trading hours. Based on a TCV for
September 2013 of six (6) billion shares, this would amount to
12,000,000 shares for the Mega Tier 2 and 45,000,000 shares for the
Mega Tier 3. Although the TCV requirement is higher for the Mega Tier
3, the Mega Tier 3 only requires that a Member add or route at least
1.5 million shares of ADV prior to 9:30 a.m. or after 4:00 p.m.,
whereas the Mega Tier 2 requires that a Member add or route at least 4
million shares prior to 9:30 a.m. or after 4:00 p.m. The Exchange
believes that these requirements essentially render the two tiers
equally difficult to obtain, and therefore proposes to offer the same
rebate for either tier.
    In order to qualify for the next tier after the Mega Tier 3, the
Ultra Tier, a Member must, on a daily basis, measured monthly, post
0.50% of TCV in ADV to EDGX to receive a rebate of $ 0.0031 per share.
The criteria for this tier is less stringent than the Mega Tier 3
because a Member aspiring to meet the Mega Tier 3 must satisfy two
criteria: (1) Add or route at least 1.5 million shares of ADV prior to
9:30 a.m. or after 4:00 p.m.; and (2) add a minimum of 0.75% of the TCV
on a daily basis measured monthly, including during both market hours
and pre and post-trading hours. The Ultra Tier only requires a Member
post 0.50% of TCV in ADV to EDGX. Based on a TCV for September 2013 of
six (6) billion shares, this would amount to 30,000,000 shares for the
Ultra Tier and 45,000,000 shares for the Mega Tier 3. The higher volume
requirement necessary to achieve the Mega Tier 3 justifies its higher
rebate.
Amendments to Lists of Added, Removal and Routed Flags
    The Exchange believes that the proposed relocation and changes to
the bullets related to ``added flags,'' ``removal flags,'' and ``routed
flags'' in its Fee Schedule are reasonable because they provide Members
with greater clarity with regard to which added, removal or routed
flags count toward certain tiers, and remove potential confusion
regarding the definition of such flags. The Exchange notes that the
proposed change is not designed to amend any fee or rebate, nor alter
the manner in which it assesses fees or calculates rebates. The
Exchange believes that the proposed amendment is intended to make the
Fee Schedule clearer and less confusing for investors and eliminate
potential investor confusion, thereby removing impediments to and
perfecting the mechanism of a free and open market and a national
market system, and, in general, protecting investors and the public
interest.
Amendment to Step-Up Tiers in Footnote 1
    The Exchange believes that changing the ``Step Up'' tiers in
Footnote 1 of its Fee Schedule to the ``Step-Up'' tiers is reasonable
because it conforms to the spelling of the proposed Tape B Step-Up Tier
as well as the step-up tier available on EDGA Exchange, Inc.
(``EDGA'').\8\ The Exchange notes that the criteria necessary to
achieve the tiers and the rates offered by the tiers would remain
unchanged.
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    \8\ EDGA, Fee Schedule, available at http://www.directedge.com/Membership/FeeSchedule/EDGXFeeSchedule.aspx (offering the ``Step-Up
Tier'').
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B. Self-Regulatory Organization's Statement on Burden on Competition

    These proposed rule changes do not impose any burden on competition
that is not necessary or appropriate in furtherance of the purposes of
the Act. The Exchange does not believe that any of these changes
represent a significant departure from previous pricing offered by the
Exchange or pricing offered by the Exchange's competitors.
Additionally, Members may opt to disfavor EDGX's pricing if they
believe that alternatives offer them better value. Accordingly, the
Exchange does not believe that the proposed changes will impair the
ability of Members or competing venues to maintain their competitive
standing in the financial markets.
Addition of Tape B Step Up Tier
    The Exchange believes that the proposed addition of the Tape B Step
Up Tier would increase intermarket competition because it would
encourage market participants to send additional liquidity in Tape B
securities to EDGX in exchange for an increased rebate. The Exchange
believes that the proposed tier would neither increase nor decrease
intramarket competition because the increased rebate offered by the
tier would apply uniformly to all Members that meet the requirements
necessary to achieve the tier.
Addition of the Mega Tier 3
    The Exchange believes that the proposed addition of Mega Tier 3
would increase intermarket competition because it would encourage
market participants to send additional liquidity to EDGX in exchange
for an increased rebate. The Exchange believes that the proposed tier
would neither increase nor decrease intramarket competition because the
increased rebate offered by the tier would apply uniformly to all
Members that meet the requirements necessary to achieve the tier.
Amendments to Lists of Added, Removal and Routed Flags
    The Exchange believes that the proposed relocation and changes to
the bullets related to ``added flags,'' ``removal flags,'' and ``routed
flags'' in its Fee Schedule would not affect intermarket nor
intramarket competition because this change is not designed to amend
any fee or rebate or alter the manner in which the Exchange assesses
fees or calculates rebates. The proposed change is intended to provide
greater transparency to Members with regard to which added, removal and
routed flags are counted towards certain tiers.
Amendment to Step-Up Tiers in Footnote 1
    The Exchange believes that the proposed non-substantive change to
the ``Step-Up'' tiers in Footnote 1 would not affect intermarket nor
intramarket competition because the change does not alter the criteria
necessary to achieve the tiers nor the rates offered by the tiers.

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

    The Exchange has not solicited, and does not intend to solicit,
comments on this proposed rule change. The Exchange has not received
any unsolicited written comments from Members or other interested
parties.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A) of the Act \9\ and Rule 19b-4(f)(2) \10\ thereunder. At any
time within 60 days of the filing of such 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.
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    \9\ 15 U.S.C. 78s(b)(3)(A).
    \10\ 17 CFR 240.19b-4 (f)(2).

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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-EDGX-2013-33 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-EDGX-2013-33. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of the filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-EDGX-2013-33 and should be
submitted on or before October 7, 2013.
---------------------------------------------------------------------------

    \11\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\11\
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-22403 Filed 9-13-13; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 76, Number 127 (Friday, July 1, 2011)]
[Proposed Rules]
[Pages 38591-38592]
[FR Doc No: 2011-16496]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 63

[EPA-HQ-OAR-2011-0344; FRL-9427-5]
RIN 2060-AQ68

National Emission Standards for Hazardous Air Pollutants:
Secondary Lead Smelting; Extension of Comment Period

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule; extension of public comment period.

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

SUMMARY: On May 19, 2011, the EPA proposed amendments to the National
Emissions Standards for Hazardous Air Pollutants for Secondary Lead
Smelting (76 FR 29032). The EPA is extending the deadline for written
comments on the proposed amendments by 21 days to July 26, 2011. The
EPA received a request for an extension from the Association of Battery
Recyclers (ABR). The ABR requested an extension in order to analyze
data and review the proposed amendments. The EPA finds this request to
be reasonable due to the significant changes the proposal would make to
the current rule.

DATES: Comments on the proposed rule published May 19, 2011 (76 FR
29032) must be received on or before July 26, 2011.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OAR-2011-0344, by one of the following methods:
     http:[sol][sol]www.regulations.gov: Follow the on-line
instructions for submitting comments.
     E-mail<EMAIL_ADDRESS>Attention Docket ID Number
EPA-HQ-OAR-2011-0344.
     Fax:<PHONE_NUMBER>. Attention Docket ID Number EPA-HQ-
OAR-2011-0344.
     Mail: U.S. Postal Service, send comments to: The EPA
Docket Center (6102T), EPA West (Air Docket), Attention Docket ID
Number EPA-HQ-OAR-2011-0344, U.S. Environmental Protection Agency,
Mailcode 2822T, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
Please include a total of two copies. In addition, please mail a copy
of your comments on the information collection provisions to the Office
of Information and Regulatory Affairs, Office of Management and Budget,
Attn: Desk Officer for the EPA, 725 17th St., NW., Washington, DC
20503.
     Hand Delivery: U.S. Environmental Protection Agency, EPA
West (Air Docket), Room 3334, 1301 Constitution Avenue, NW.,
Washington, DC 20004, Attention Docket ID Number EPA-HQ-OAR-2011-0344.
Such deliveries are only accepted during the Docket's normal hours of
operation, and special arrangements should be made for deliveries of
boxed information. Please include a total of two copies.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-OAR-
2011-0344. The EPA's policy is that all comments received will be
included in the public docket without change and may be made available
online at http:[sol][sol]www.regulations.gov, including any personal
information provided, unless the comment includes information claimed
to be Confidential Business Information (CBI) or other information
whose disclosure is restricted by statute. Do not submit information
that you consider to be CBI or otherwise protected through
http:[sol][sol]www.regulations.gov or e-mail. The
http:[sol][sol]www.regulations.gov Web site is an ``anonymous access''
system, which means the EPA will not know your identity or contact
information unless you provide it in the body of your comment. If you
send an email comment directly to EPA without going through
http:[sol][sol]www.regulations.gov, your e-mail address will be
automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, the EPA recommends that you include your
name and other contact information in the body of your comment and with
any disk or CD-ROM you submit. If the EPA cannot read your comment due
to technical difficulties and cannot contact you for clarification, the
EPA may not be able to consider your comment. Electronic files should
avoid the use of special characters, any form of encryption, and be
free of any defects or viruses.
    Docket: All documents in the docket are listed in the
http:[sol][sol]www.regulations.gov index. Although listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, will be publicly available only
in hard copy. Publicly available docket materials are available either
electronically in http:[sol][sol]www.regulations.gov or in hard copy at
the EPA Docket Center, EPA West, Room 3334, 1301 Constitution Ave.,
NW., Washington, DC. The Public Reading Room is open from 8:30 a.m. to
4:30 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Public Reading Room is<PHONE_NUMBER>, and the
telephone number for the Docket Center is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Questions concerning the proposed rule
should be addressed to Mr. Chuck French, Office of Air Quality Planning
and Standards, Sector Policies and Programs Division, Metals and
Inorganic Chemicals Group (D243-02), Environmental Protection Agency,
Research Triangle Park, NC 27711, telephone number:<PHONE_NUMBER>; fax
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: For the reasons noted above, the public
comment period will now end on July 26, 2011.

How can I get copies of the proposed rule and other related
information?

    The proposed rule titled, National Emission Standards for Hazardous
Air Pollutants: Secondary Lead Smelting, was published May 19, 2011 (76
FR 29032). The EPA has established the public docket for the proposed
rulemaking under docket ID No. EPA-HQ-OAR-2011-0344, and a copy of the
proposed rule is available in the docket. We note that, since the
proposed rule was published, additional materials have been added to
the docket. Information on how to access the docket

is presented above in the ADDRESSES section.

    Dated: June 24, 2011.
Gina McCarthy,
Assistant Administrator.
[FR Doc. 2011-16496 Filed 6-30-11; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 75, Number 35 (Tuesday, February 23, 2010)]
[Notices]
[Pages 8086-8087]
[FR Doc No: 2010-3409]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0085]

Preventive Controls for Fresh Produce; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
opening of a docket to obtain information about current practices and
conditions for the production and packing of fresh produce. FDA is
establishing this docket in order to provide an opportunity for
interested parties to provide information and share views that will
inform the development of safety standards for fresh produce at the
farm and packing house and strategies and cooperative efforts to ensure
compliance.

DATES: Submit electronic or written comments by May 24, 2010.

ADDRESSES: 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.

FOR FURTHER INFORMATION CONTACT: Michelle A. Smith, Center for Food
Safety and Applied Nutrition (HFS-317), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740-3835,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    On March 19, 2009, President Barack Obama established a new Food
Safety Working Group (FSWG), chaired by the Secretaries of the
Department of Health and Human Services and the Department of
Agriculture. In announcing creation of the FSWG, the President said the
group would advise him on how to upgrade U.S. food safety laws for the
21st century, foster coordination of food safety efforts throughout the
Government, and ensure laws are being adequately enforced to keep the
American people safe from foodborne illness (Ref. 1).
    On July 1, 2009, the FSWG recommended a new public health-focused
approach to food safety based on three core principles: (1)
Prioritizing prevention; (2) strengthening surveillance and
enforcement; and (3) improving response and recovery (Ref. 1). The FSWG
announced steps to be taken by FDA and other Federal agencies to
achieve these goals.
    With regard to fresh produce, the FSWG announced that FDA would
issue ``commodity-specific draft guidance on preventive controls that
industry can implement to reduce the risk of microbial contamination in
the production and distribution of tomatoes, melons, and leafy greens''
(Ref. 1). The FSWG also announced that FDA, over the next 2 years,
would ``seek public comment and work to require adoption of these
approaches through regulation'' (Ref. 1).
    On August 3, 2009, FDA made available draft guidances to industry
for leafy greens, melons, and tomatoes (Refs. 3 through 5). FDA is now
establishing a docket in order to provide an opportunity for interested
parties to provide information and share views that will inform the
development of: (1) Safety standards for fresh produce at the farm and
packing house and (2) strategies and cooperative efforts to ensure
compliance.

II. Request for Comments and Information

    We are requesting comments that will inform the development of: (1)
Safety standards for fresh produce at the farm and packing house and
(2) strategies and cooperative efforts to ensure compliance. In
particular, we welcome input on any of these general categories:
     Role of the good agricultural practice guidelines entitled
``Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and
Vegetables'' (GAPs Guide, Ref. 6);
     Standards for domestic and foreign growers and packers;
     Identification and prioritization of risk factors;
     Environmental assessment of hazards and possible pathways
of contamination;
     The impact of scale of growing operations on the nature
and degree of possible food safety hazards;
     Methods to tailor preventive controls to particular
hazards and conditions affecting an operation;
     Possible approaches to tailoring preventive controls to
the scale of an operation so that the controls achieve an appropriate
level of food safety protection and are feasible for a wide range of
large and small operations;
     Coordination of produce food safety practices and
sustainable and/or organic production methods;
     Coordination of produce food safety practices and
environmental and/or conservation goals or practices;
     Coordination of produce food safety practices and Federal,
State, local and tribal government statutes and regulations;
     Microbial testing;
     Post-harvest operations and the role of the current good
manufacturing practices in 21 CFR part 110;
     Records and other documentation that would be useful to
industry and regulators in ensuring the safety of fresh produce; and
     Strategies to enhance compliance.
    The agency will consider information submitted to the docket in
developing safety standards for fresh produce. Comments previously
submitted to the Division of Dockets Management for the following
dockets will also be considered by FDA and do not need to be
resubmitted:
     ``Draft Guidance for Industry: Guide to Minimize Microbial
Food Safety Hazards of Tomatoes; Availability'' (74 FR 38438, August 3,
2009; Docket No. FDA-2009-D-0346);
     ``Draft Guidance for Industry: Guide to Minimize Microbial
Food Safety Hazards of Melons'' (74 FR 38437, August 3, 2009; Docket
No. FDA-2009-D-0347);
     ``Draft Guidance for Industry: Guide to Minimize Microbial
Food Safety Hazards of Leafy Greens; Availability'' (74 FR 38439,
August 3, 2009; Docket No. FDA-2009-D-0348); and

     ``Guide to Minimize Microbial Food Safety Hazards for
Fresh Fruits and Vegetables; Request for Comments and for Scientific
Data and Information'' (73 FR 51306, September 2, 2008; Docket No. FDA-
2008-N-0455).

III. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) electronic or written comments regarding this docket.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified 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.

IV. References

    FDA has placed the following references on display in FDA's
Division of Dockets Management (see ADDRESSES). You may see them
between 9 a.m. and 4 p.m., Monday through Friday. (FDA has verified the
Web site addresses, but FDA is not responsible for any subsequent
changes to Web sites after this document publishes in the Federal
Register.)
    1. Food Safety Working Group, ``Food Safety Working Group: Key
Findings'' (July 1, 2009), Available at http://www.foodsafetyworkinggroup.gov/ContentKeyFindings/HomeKeyFindings.htm,
Accessed and printed on January 11, 2010.
    2. Food Safety Working Group, ``President's Food Safety Working
Group: Delivering Results,'' Available at http://www.foodsafetyworkinggroup.gov/FSWG_Fact_Sheet.pdf, Accessed and
printed on January 11, 2010.
    3. FDA, ``Draft Guidance for Industry: Guide to Minimize Microbial
Food Safety Hazards of Tomatoes; Availability'' (74 FR 38438, August 3,
2009).
    4. FDA, ``Draft Guidance for Industry: Guide to Minimize Microbial
Food Safety Hazards of Melons'' (74 FR 38437, August 3, 2009).
    5. FDA, ``Draft Guidance for Industry: Guide to Minimize Microbial
Food Safety Hazards of Leafy Greens; Availability'' (74 FR 38439,
August 3, 2009).
    6. FDA, ``Guidance for Industry: Guide to Minimize Microbial Food
Safety Hazards for Fresh Fruits and Vegetables,'' October 26, 1998,
Available at http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/ProduceandPlanProducts/ucm064574.htm.

    Dated: February 17, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-3409 Filed 2-18-10; 11:15 am]
BILLING CODE 4160-01-S


[Federal Register Volume 76, Number 181 (Monday, September 19, 2011)]
[Rules and Regulations]
[Pages 57905-57906]
[FR Doc No: 2011-23865]

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

Food and Drug Administration

21 CFR Part 522

[Docket No. FDA-2011-N-0003]

Implantation or Injectable Dosage Form New Animal Drugs;
Ivermectin

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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

SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval of an abbreviated new animal drug
application (ANADA) filed by Cross Vetpharm Group Ltd. The ANADA
provides for use of an ivermectin injectable solution for treatment and
control of various internal and external parasites in cattle, swine,
reindeer, and American bison.

DATES: This rule is effective September 19, 2011.

FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for
Veterinary Medicine (HFV-170), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>, e-mail:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Cross Vetpharm Group Ltd., Broomhill Rd.,
Tallaght, Dublin 24, Ireland, filed ANADA 200-447 for the use of
BIMECTIN (ivermectin) Injection for Cattle and Swine for treatment and
control of various internal and external parasites in cattle, swine,
reindeer, and American bison. Cross Vetpharm Group Ltd.'s BIMECTIN
Injection for Cattle and Swine is approved as a generic copy of Merial
Ltd.'s IVOMEC (ivermectin) Injection for Cattle and Swine, approved
under NADA 128-409. The ANADA is approved as of July 5, 2011, and the
regulations in 21 CFR 522.1192 are amended to reflect the approval.
    A summary of safety and effectiveness data and information
submitted to support approval of this application may be seen in the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, between 9 a.m. and 4
p.m., Monday through Friday.
    FDA has determined under 21 CFR 25.33 that this action is of a type
that does not individually or cumulatively have a significant effect on
the human environment. Therefore, neither an environmental assessment
nor an environmental impact statement is required.
    This rule does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because it is a rule of ``particular applicability.''
Therefore, it is not subject to the congressional review requirements
in 5 U.S.C. 801-808.

List of Subjects in 21 CFR Part 522

    Animal drugs.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR part 522 is
amended as follows:

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 522 continues to read as
follows:

    Authority: 21 U.S.C. 360b.

0
2. In Sec.  522.1192, revise paragraph (b)(2) to read as follows:

Sec.  522.1192  Ivermectin.

* * * * *
    (b) * * *
    (2) Nos. 055529, 058005, 059130, and 061623 for use of the product
described in paragraph (a)(2) of this section as in paragraphs (e)(2),
(e)(3), (e)(4), and (e)(5) of this section.
* * * * *

    Dated: September 13, 2011.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2011-23865 Filed 9-16-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 83, Number 152 (Tuesday, August 7, 2018)]
[Notices]
[Page 38690]
[FR Doc No: 2018-16827]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP18-530-000]

Notice of Request Under Blanket Authorization; Florida Gas
Transmission, LLC

    Take notice that on July 19, 2018, Florida Gas Transmission, LLC
(FGT), 1300 Main St., Houston, Texas 77002, filed in Docket No. CP18-
530-000 a prior notice request pursuant to sections 157.205, 157.208,
157.210 and 157.211 of the Commission's regulations under the Natural
Gas Act (NGA), requesting authorization to construct/modify, own,
maintain and operate, certain natural gas mainline facilities and
appurtenances in Santa Rosa County, Florida, and modify an existing
delivery point, in Escambia County, Alabama for its South Alabama
Project. FGT's South Alabama Project would provide up to 60,000 million
British thermal units per day of firm transportation service to two
shippers, all as more fully set forth in the application which is on
file with the Commission and open to public inspection. FGT estimates
the cost of the proposed project to be approximately $7,000,000. The
filing may also be viewed on the web 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, please contact FERC Online Support at
[email protected] or toll free at<PHONE_NUMBER>, or TTY,
contact<PHONE_NUMBER>.
    Any questions concerning this application may be directed to Blair
Lichtenwalter, Senior Director of Certificates, Florida Gas
Transmission Company, LLC, 1300 Main St., Houston, Texas 77002, or call
(713) 989-2605, or fax<PHONE_NUMBER>, or via eMail to
[email protected].
    Any person or the Commission's staff may, within 60 days after
issuance of the instant notice by the Commission, file pursuant to Rule
214 of the Commission's Procedural Rules (18 CFR 385.214) a motion to
intervene or notice of intervention and pursuant to section 157.205 of
the regulations under the NGA (18 CFR 157.205), a protest to the
request. If no protest is filed within the time allowed therefore, the
proposed activity shall be deemed to be authorized effective the day
after the time allowed for filing a protest. If a protest is filed and
not withdrawn within 30 days after the allowed time for filing a
protest, the instant request shall be treated as an application for
authorization pursuant to section 7 of the NGA.
    Pursuant to section 157.9 of the Commission's rules, 18 CFR 157.9,
within 90 days of this Notice the Commission staff will either:
Complete its environmental assessment (EA) and place it into the
Commission's public record (eLibrary) for this proceeding; or issue a
Notice of Schedule for Environmental Review. If a Notice of Schedule
for Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission staff's issuance of
the EA for this proposal. The filing of the EA in the Commission's
public record for this proceeding or the issuance of a Notice of
Schedule for Environmental Review will serve to notify federal and
state agencies of the timing for the completion of all necessary
reviews, and the subsequent need to complete all federal authorizations
within 90 days of the date of issuance of the Commission staff's EA.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commenter's will be
placed on the Commission's environmental mailing list, will receive
copies of the environmental documents, and will be notified of meetings
associated with the Commission's environmental review process.
Environmental commenter's will not be required to serve copies of filed
documents on all other parties. However, the non-party commentary, will
not receive copies of all documents filed by other parties or issued by
the Commission (except for the mailing of environmental documents
issued by the Commission) and will not have the right to seek court
review of the Commission's final order.
    The Commission strongly encourages electronic filings of comments,
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 5 copies of the protest or intervention to the
Federal Energy regulatory Commission, 888 First Street NE, Washington,
DC 20426.

    Dated: July 27, 2018.
Kimberly D. Bose,
Secretary.
[FR Doc. 2018-16827 Filed 8-6-18; 8:45 am]
 BILLING CODE 6717-01-P


"Fraas, Arthur G."<EMAIL_ADDRESS> 01/23/2008 07:07 PM

To

Alexander Cristofaro/DC/USEPA/US@EPA, Lydia Wegman/RTP/USEPA/US@EPA

cc

"King, Heidi R."<EMAIL_ADDRESS> Subject

We have a meeting scheduled for 10 AM on Friday w/ Theresa Gorman and Anne Smith on the O3 risk assessment.


[Federal Register Volume 77, Number 29 (Monday, February 13, 2012)]
[Rules and Regulations]
[Pages 7521-7523]
[FR Doc No: 2012-3115]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2011-0571; Directorate Identifier 2010-NM-263-AD;
Amendment 39-16950; AD 2012-03-09]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for all
Model 747SP series airplanes. This AD was prompted by a report of a
rudder hard-over event on a Model 747-400 series airplane, caused by a
rudder power control module (PCM) manifold cracking and separating in
the area of the yaw damper cavity end-cap. This condition could result
in a hard-over of the rudder surface leading to an increase in pilot
workload and a possible high-speed runway excursion upon landing, in
the event of failure of the lower or upper rudder PCM manifold. This AD
requires replacing or modifying the upper and lower rudder PCMs. We are
issuing this AD to correct the unsafe condition on these products.

DATES: This AD is effective March 19, 2012.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in the AD as of March 19,
2012.

ADDRESSES: For Boeing service information identified in this AD,
contact Boeing Commercial Airplanes, Attention: Data & Services
Management, P.O. Box 3707, MC 2H-65, Seattle, Washington 98124-2207;
telephone<PHONE_NUMBER>, extension 1; fax<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>Internet https://www.myboeingfleet.com. For
Parker service information identified in this AD, contact Parker
Aerospace, 14300 Alton Parkway, Irvine, California 92618; telephone
949-833-3000; Internet http://www.parker.com. You may review copies of
the referenced service information at the FAA, Transport Airplane
Directorate, 1601 Lind Avenue SW., Renton, Washington. For information
on the availability of this material at the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov; 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 address for the
Docket Office (phone:<PHONE_NUMBER>) is Document Management Facility,
U.S. Department of Transportation, Docket Operations, M-30, West
Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE.,
Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Marie Hogestad, Aerospace Engineer,
Systems and Equipment Branch, ANM-130S, FAA, Seattle Aircraft
Certification Office, 1601 Lind Avenue SW., Renton, Washington 98057-
3356; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to include an AD that would apply to the specified products.
That NPRM was published in the Federal Register on June 22, 2011 (76 FR
36390). That NPRM proposed to require replacing or modifying the upper
and lower rudder PCMs.

Comments

    We gave the public the opportunity to participate in developing
this AD. The following presents the comments received on the proposal
and the FAA's response to each comment.

Support for the NPRM (76 FR 36390, June 22, 2011)

    The National Transportation Safety Board fully supports the NPRM
(76 FR 36390, June 22, 2011).

Request To Clarify the Discussion Section and Paragraph (e) of NPRM (76
FR 36390, June 22, 2011)

    Boeing requested that we revise the Discussion section and
paragraph (e) of the NPRM (76 FR 36390, June 22, 2011) to clarify that
the corrective actions are not intended to prevent the manifold from
cracking, but rather to prevent the cracking of the manifold from
progressing to a rudder surface hard-over. Boeing pointed out that the
secondary retention device incorporated in Boeing Alert Service
Bulletin 747-27A2497, dated September 30, 2010, prevents the yaw damper
modulating piston assembly from shifting after a manifold failure,
therefore, preventing a rudder surface hard-over. Boeing suggested
removing the phrase, ``if not corrected,'' from the sentence,
``Cracking in a rudder PCM manifold, if not corrected, could result in
a failure of the upper or lower rudder PCM manifold which could result
in a hard-over of the rudder surface leading to an increase in pilot
workload and a possible high-speed runway excursion upon landing.'' In
addition, Boeing suggested revising the sentence, ``Although commanding
full retract, pilot pedal inputs were ineffective in moving the lower
rudder back to the right,'' to replace the term ``retract'' with
``right rudder,'' and revising the sentence, ``These events did not
result in a hard-over, but created the need for a retention feature
solution specified in AD 2008-13-03, Amendment 39-15566, for Model 747-
400, -400D, and -400F series airplanes,'' to clarify that the
additional three events did not result in end-cap separation or a hard-
over.
    We agree that replacement or modification of the upper and lower
rudder PCMs is intended to prevent the yaw damper modulating piston
assembly from shifting after a manifold failure, consequently
preventing a rudder surface hard-over. Therefore, we have revised
paragraph (e) and the corresponding language in the Summary of this AD
to clarify the intent. However, we cannot revise the Discussion section
of this AD, because that section is not re-stated in this final rule.

Conclusion

    We reviewed the relevant data, considered the comments received,
and determined that air safety and the public interest require adopting
the AD with the changes described previously and minor editorial
changes. We have determined that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM (76 FR 36390, June 22, 2011) for correcting the unsafe condition;
and
     Do not add any additional burden upon the public than was
already proposed in the NPRM (76 FR 36390, June 22, 2011).
    We also determined that these changes will not increase the
economic burden on any operator or increase the scope of the AD.

Costs of Compliance

    We estimate that this AD affects 7 airplanes of U.S. registry.
    We estimate the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost on U.S.
               Action                      Labor cost          Parts cost     Cost per product      operators
----------------------------------------------------------------------------------------------------------------
Replace rudder PCM (P/N 241700-      11 work-hours x $85              $5,856            $6,791           $47,537
 1007).                               per hour = $935.
Replace rudder PCM (P/N 241700-      11 work-hours x $85               8,568             9,503            66,521
 1005).                               per hour = $935.
Modify rudder PCM (P/N<PHONE_NUMBER>)  3 work-hours x $85                1,374             1,629            11,403
                                      per hours = $255.
Modify rudder PCM (P/N<PHONE_NUMBER>)  3 work hours x $85                4,086             4,341            30,387
                                      per hour = $255.
----------------------------------------------------------------------------------------------------------------

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

    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 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 airworthiness
directive (AD):

2012-03-09 The Boeing Company: Amendment 39-16950; Docket No. FAA-
2011-0571; Directorate Identifier 2010-NM-263-AD.

(a) Effective Date

    This AD is effective March 19, 2012.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to all The Boeing Company Model 747SP series
airplanes, certificated in any category.

(d) Subject

    Joint Aircraft System Component (JASC)/Air Transport Association
(ATA) of America Code 27, Flight Controls.

(e) Unsafe Condition

    This AD was prompted by a report of a rudder hard-over event on
a Model 747-400 series airplane, caused by a rudder power control
module (PCM) manifold cracking and separating in the area of the yaw
damper cavity end-cap. We are issuing this AD to prevent a hard-over
of the rudder surface leading to an increase in pilot workload and a
possible high-speed runway excursion upon landing, in the event of
failure of the lower or upper rudder PCM manifold.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Replace or Modify Rudder PCMs

    Within 24 months or 8,400 flight hours after the effective date
of this AD, whichever occurs first, do the replacement specified in
paragraph (g)(1) of this AD or the modification specified in
paragraph (g)(2) of this AD for the upper and lower rudder PCMs, in
accordance with the Accomplishment Instructions of Boeing Alert
Service Bulletin 747-27A2497, dated September 30, 2010.
    (1) Replace any rudder PCM having Boeing part number (P/N)
60B80093-3 (Parker P/N<PHONE_NUMBER>) or Boeing P/N 60B80093-4 (Parker
P/N<PHONE_NUMBER>) with rudder PCM having Boeing P/N 60B80093-104
(Parker P/N<PHONE_NUMBER>).
    (2) Modify any rudder PCM having Boeing P/N 60B80093-3 (Parker
P/N<PHONE_NUMBER>) or Boeing P/N 60B80093-4 (Parker P/N<PHONE_NUMBER>).

    Note 1 to paragraph (g): Boeing Alert Service Bulletin 747-
27A2497, dated September 30, 2010, refers to Parker Service Bulletin
241700-27-333, dated January 26, 2010, as an additional source of
guidance for modifying the upper and lower rudder PCM manifold
access caps provided in Option 2 of Work Packages 1 and 2 of Boeing
Alert Service Bulletin 747-27A2497, dated September 30, 2010.

(h) Parts Installation

    As of the effective date of this AD, no person may install a
rudder PCM having Boeing P/N 60B80093-3 (Parker P/N<PHONE_NUMBER>) or
Boeing P/N 60B80093-4 (Parker P/N<PHONE_NUMBER>), on any airplane.

(i) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Seattle Aircraft Certification Office (ACO),
FAA, has the authority to approve AMOCs for this AD, if requested
using the procedures found in 14 CFR 39.19. In accordance with 14
CFR 39.19, send your request to your principal inspector or local
Flight Standards District Office, as appropriate. If sending
information directly to the manager of the ACO, send it to the
attention of the person identified in the Related Information
section of this AD. Information may be emailed to<EMAIL_ADDRESS>    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.

(j) Related Information

    For more information about this AD, contact Marie Hogestad,
Aerospace Engineer, Systems and Equipment Branch, ANM-130S, FAA,
Seattle Aircraft Certification Office, 1601 Lind Avenue SW., Renton,
Washington 98057-3356; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>;
email<EMAIL_ADDRESS>
(k) Material Incorporated by Reference

    You must use the following service information to do the actions
required by this AD, unless the AD specifies otherwise. The Director
of the Federal Register approved the incorporation by reference
(IBR) under 5 U.S.C. 552(a) and 1 CFR part 51 of the

following service information on the date specified:
    (1) Boeing Alert Service Bulletin 747-27A2497, dated September
30, 2010, approved for IBR March 19, 2012.
    (2) For Boeing service information identified in this AD,
contact Boeing Commercial Airplanes, Attention: Data & Services
Management, P.O. Box 3707, MC 2H-65, Seattle, Washington 98124-2207;
telephone<PHONE_NUMBER>, extension 1; fax<PHONE_NUMBER>; email
<EMAIL_ADDRESS>Internet https://www.myboeingfleet.com. You
may review copies of the referenced service information at the FAA,
Transport Airplane Directorate, 1601 Lind Avenue SW., Renton,
Washington. For information on the availability of this material at
the FAA, call<PHONE_NUMBER>.
    (3) You may review copies of the service information at the FAA,
Transport Airplane Directorate, 1601 Lind Avenue SW., Renton,
Washington. For information on the availability of this material at
the FAA, call<PHONE_NUMBER>.
    (4) You may also review copies of the service information that
is incorporated by reference at the National Archives and Records
Administration (NARA). For information on the availability of this
material at an NARA facility, call<PHONE_NUMBER>, or go to http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

    Issued in Renton, Washington, on January 27, 2012.
Kalene C. Yanamura,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2012-3115 Filed 2-10-12; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 78, Number 39 (Wednesday, February 27, 2013)]
[Notices]
[Pages 13348-13349]
[FR Doc No: 2013-04535]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0001]

Science Board to the Food and Drug Administration Advisory
Committee; Amendment of Notice

AGENCY:  Food and Drug Administration, HHS.

ACTION: Notice.

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

    The Food and Drug Administration (FDA) is announcing an amendment
to the notice of meeting of the Science Board to the Food and Drug
Administration. This meeting was announced in the Federal Register of
January 30, 2013 (78 FR 6332). The amendment is being made to reflect
changes in the Date and Time, Agenda, and Procedures portions of the
document. There are no other changes.

FOR FURTHER INFORMATION CONTACT: Martha Monser, Office of the Chief
Scientist, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 32, rm. 4286, Silver Spring, MD 20993,<PHONE_NUMBER>, or FDA
Advisory Committee Information Line, 1-800-741-8138<PHONE_NUMBER> in
the Washington DC area). Please call the Information Line for up-to-
date information on this meeting.

SUPPLEMENTARY INFORMATION:  In the Federal Register of January 30,
2013, FDA announced that a meeting of the Science Board to the Food and
Drug Administration would be held on February 27, 2013.
    1. On page 6332, in the third column, the Date and Time portion of
the document is changed to read as follows:
    Date and Time: The meeting will be held on Wednesday, February 27,
2013, from approximately 8:30 a.m. to 3:45 p.m.
    2. On page 6333, in the first column, the Agenda portion of the
document is changed to read as follows:
    Agenda: On February 27, 2013, the Science Board will be provided
with updates and/or a draft report from the Center for Devices and
Radiological Health Research Review subcommittee and the Global Health
subcommittee. Progress updates will be presented regarding the Global
Health subcommittee and the recently established Center for Biologics
Evaluation and Research Review Postmarketing Safety Review
subcommittee. Overviews of genomics activities at the Centers for Food
Safety and Applied Nutrition and Veterinary Medicine will be presented,
along with plans for an Agencywide working group to address
crosscutting genomics activities. Finally, recipients of the fiscal
year 2012 Scientific Achievement Awards (selected by the Science Board)
will provide overviews of the activities for which the awards were
given.
    3. On page 6333, in the second column, in the Procedures section,
the third sentence is changed to read as follows:
    Procedures: Oral presentations from the public will be scheduled
between approximately 3 p.m. and 3:30 p.m.
    This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees.

    Dated: February 20, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2013-04535 Filed 2-26-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 81, Number 173 (Wednesday, September 7, 2016)]
[Notices]
[Page 61731]
[FR Doc No: 2016-21413]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Notice of Availability of the Southern California Metroplex Final
Environmental Assessment and Finding of No Significant Impact/Record of
Decision

AGENCY: Federal Aviation Administration.

ACTION: Notice of availability of Final Environmental Assessment and
Finding of No Significant Impact/Record of Decision.

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

SUMMARY: The Federal Aviation Administration (FAA) is issuing this
notice to advise the public that it has published a Final Environmental
Assessment and Finding of No Significant Impact/Record of Decision for
the Southern California Metroplex project.

FOR FURTHER INFORMATION CONTACT: Ryan Weller, Environmental Specialist,
Western Service Center-Operations Support Group, 1601 Lind Ave. SW.,
Renton, WA 98057, email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The FAA has prepared a Final Environmental
Assessment (EA) to assess the potential environmental impacts of the
SoCal Metroplex project in compliance with the National Environmental
Policy Act of 1969, 42 U.S.C. 4321 et seq. This notice announces that
based on the information and analysis contained in the EA, the FAA is
issuing a Finding of No Significant Impact and Record of Decision
(FONSI/ROD) for the project. The EA and FONSI/ROD document the FAA's
determination that the project, as proposed, would not significantly
affect the quality of the human environment and that an Environmental
Impact Statement (EIS) is therefore not necessary. The FONSI/ROD
documents the FAA's decision to proceed with the preferred alternative
detailed in the EA. The SoCal Metroplex project will improve the
efficiency of the national airspace system in the Southern California
area by optimizing aircraft arrival and departure procedures at 21
Southern California airports.
    Availability: The EA and FONSI/ROD are available for public review
at: (1) Online at: http://www.metroplexenvironmental.com/socal_metroplex/socal_introduction.html.
    (2) Hard-copies are available at these libraries:

    --Los Angeles Central Library, 630 W. 5th Street, Los Angeles, CA
90071
    --Santa Monica Public Library, 601 Santa Monica Boulevard, Santa
Monica, CA 90401
    --Anaheim Public Library, 500 W. Broadway, Anaheim, CA 92805
    --Riverside Public Library, 3581 Mission Inn Avenue, Riverside, CA
92501
    --Point Loma/Hervey Library, 3701 Voltaire St., San Diego, CA 92107
    --San Diego Central Library, 330 Park Boulevard, San Diego, CA
92101
    --E.P. Foster Library, 651 E. Main Street, Ventura, CA 93001

    (3) Electronic versions of the EA and FONSI/ROD are available at
libraries in the General Study Area. A complete list of libraries with
electronic copies of the EA and FONSI/ROD is available online: http://www.metroplexenvironmental.com/socal_metroplex/socal_introduction.html.

    Issued in Washington, DC on August 31, 2016.
Gary Norek,
Director, Airspace Services, AJV-1.
[FR Doc. 2016-21413 Filed 9-2-16; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register: September 17, 2008 (Volume 73, Number 181)]
[Notices]
[Page 53893-53894]
[DOCID:fr17se08-117]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[FEMA-1785-DR]

Florida; Amendment No. 7 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Florida (FEMA-1785-DR), datedAugust 24, 2008, and
related determinations.

DATES: Effective Date: September 8, 2008.

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

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the State of Florida is hereby amended to include the following
areas among those areas determined to have been adversely affected by
the catastrophe declared a major disaster by the President in his
declaration of August 24, 2008.

    Clay, Flagler, Gulf, Highlands, Martin, Suwannee, and Taylor
Counties for Public Assistance.

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

(Presidentially Declared Disasters); 97.039, Hazard Mitigation
Grant.)

R. David Paulison,
Administrator, Federal Emergency Management Agency.
[FR Doc. E8-21648 Filed 9-16-08; 8:45 am]

BILLING CODE 9110-10-P


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON D.C., 20460

								   PC Code: 128008								         	    DP Barcode: D336183, D341459

Date: August 10, 2007

MEMORANDUM

SUBJECT:	Drinking Water Assessment for the IR-4 Petition for the Use of Boscalid on Tropical Fruits and Fresh Herbs, and a Proposed New Use on Cotton

TO:		Shaja Brothers, Risk Manager

		Minor Use Team, Registration Division (7505P)

		Bryant Crowe, Product Manager

		Fungicide Branch, Registration Division (7507P)

		Christina Swartz, Branch Chief

		Health Effects Division (7509P)

FROM:	Cheryl Sutton, Ph.D., Environmental Scientist

		Environmental Risk Branch IV

		Environmental Fate and Effects Division (7507P)

REVIEWED

BY:		Marietta Echeverria, RAPL

		Environmental Risk Branch IV

		Environmental Fate and Effects Division (7507P)

APPROVED

BY:		Elizabeth Behl, Branch Chief

		Environmental Risk Branch IV

		Environmental Fate and Effects Division (7507P)

The Environmental Fate and Effects Division (EFED) has completed a drinking water assessment for the Inter-Region 4 (IR-4) petition for use of boscalid on tropical fruits, and fresh herbs and the proposed new use on cotton.  The registrant, BASF, was previously granted registration of boscalid for use on turf, vegetables, canola, fruit and nut crops in the U.S. and Canada (May, 2003) and subsequently for soybeans, pome fruit and hops (Nov. 2003) and leaf vegetables (excluding brassica; 2005).  Complete risk assessments for these uses can be found in the May 28, 2003 memo, “EFED Risk Assessment for Section 3 Registration of BAS 510 F (Nicobifen)” (DP Barcode D278387 and others); the November 10, 2003 memo, “Risk Assessment for Proposed Uses of Boscalid on Soybeans, Pome Fruit, and Hops” (DP Barcode 293435/293436); and the May 5, 2005 memo “Drinking Water Memo for Proposed Uses of Boscalid on Leafy Vegetables” (DP Barcode 313814).

Application rates for the proposed new uses are presented below in Table 1 along with information on the maximum use rate (for turf) among all registered uses to date.

Table 1.  Application rates for the proposed new uses of boscalid and the maximum use rate for turf.

Crop Type	Maximum Rate per Application (lbs a.i./A) and Max. Number of Applications	Maximum  Seasonal Application Rate (lbs a.i./A/season) Application Interval

(days)	Pre-Harvest Interval

(days)

Tropical fruits and Fresh Herbs	0.29 (2)	0.58	7	0

Cotton (foliar)	0.39 (2)	0.79	7-14	30

Turf (Pristine, Reg. # 7969-198?)	0.35 (6)	2.1	14-21	not applicable

Boscalid is a persistent compound with low mobility in most soils. The primary degradation pathway is aerobic soil metabolism, which proceeds slowly and results in the formation of intermediates which are relatively rapidly transformed into CO2 or bound soil residues.  Boscalid is stable to hydrolysis and to photolysis on soil and in water.  The compound is also not transformed to any significant extent in either aerobic or anaerobic aquatic systems.

This memo provides estimated drinking water concentrations (EDWCs) for the Health Effects Division to use in their dietary risk assessment for the use of boscalid on tropical fruits, herbs and cotton.  Since the proposed new uses have lower total maximum use rates than on the previously approved use on turf, the EDWCs for turf still represent the maximum exposures and are recommended for use in HED’s risk assessment.  The values reported here differ slightly from those reported previously, however, as a percentage crop area (PCA) factor was not used with turf, as is consistent with EFED’s policy for non-agricultural crop uses.  The new values of 100.6 ppb (acute) and 29.6 ppb (chronic) are slightly higher than the previously reported respective values of 87.5 ppb and 25.8 ppb.

Although the single application rate for cotton exceeds the single application rate for turf, and the application interval for cotton is shorter, additional modeling (not presented here) indicated that EDWCs from cotton use are well below (>11X) those determined for turf for both acute and chronic exposure.  This is in part due to the crop-specific percent cropped area (PCA) for cotton which is 0.20.

The Estimated Drinking Water Concentrations (EDWC) for boscalid in surface water and groundwater were calculated using the screening model FIRST (FQPA Index Reservoir Screening Tool; v.1.1.0; dated 12/12/2005) and the regression model SCI-GROW (Screening Concentration in Ground Water, v.2.3; dated 7/29/2003), respectively.    The acute and chronic surface water EDWCs and groundwater EDWCs determined for the turf use are presented in Table 2.  The model inputs are presented in Tables 3 and 4.  Output files are presented in Appendices A and B.

Table 2.  Maximum Tier 1 Estimated Drinking Water Concentrations for boscalid in groundwater and surface water based on turf use at the maximum rate of 2.1 lb ai/A/year.

Drinking Water Source (Model Used)	Use/Rate Modeled (lb ai/A)	Maximum Estimated Drinking Water Concentration (EDWC; ppb)

Groundwater

(SCI-GROW2)	Ground spray/0.35 x 6 applications; annual total of 2.1  Acute and Chronic	0.63

Surface Water (FIRST)	Ground spray/0.35 x 6 applications; annual total of 2.1	Acute	100.6

	Ground spray/0.35 x 6 applications; annual total of 2.1 	Chronic	29.6

Table 3.  Input values used for boscalid Tier I surface water modeling with FIRST.



Depth of Incorporation (inches)	0	Input parameter guidance.	Ground application

Method of Application	ground spray	Label	

Solubility in Water (mg/L or ppm)	6	Physical/chemical property data.	

Aerobic Aquatic Metabolism Half-life (days)	stable	MRID 45405214	

Hydrolysis Half-life (days)	stable	MRID 45405205	

Aquatic Photolysis Half-life  @ pH 7 (days)	stable	MRID 45405206	

Table 4.  Input values used for boscalid Tier I groundwater modeling with SCI-GROW2.



Maximum No. of Applications/Year	6	Label	

Appendix A  -  FIRST OUTPUT FILE

   RUN No.   1 FOR boscalid         ON   turf          * INPUT VALUES *

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

    RATE (#/AC)   No.APPS &   SOIL  SOLUBIL  APPL TYPE  %CROPPED INCORP

     ONE(MULT)    INTERVAL    Koc   (PPM )   (%DRIFT)     AREA    (IN)

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

   .350(  1.978)   6  14     655.0    6.0   GROUND( 6.4) 10⸰‰†⸠ര഍†䘠䕉䑌䄠䑎删卅剅佖剉䠠䱁䱆䙉⁅䅖 啌卅⠠䅄卙
†ⴭⴭⴭⴭⴭⴭⴭⴭⴭⴭⴭⴭⴭⴭⴭⴭ ⴭⴭⴭⴭⴭⴭⴭⴭⴭⴭⴭⴭⴭⴭⴭⴭⴭⴭ†䕍䅔佂䥌 ⁃䐠奁⁓乕䥔⁌䠠䑙佒奌䥓⁓†䡐呏䱏卙卉†䴠呅䉁䱏 䍉†佃䉍义䑅

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    (FIELD)  RAIN/RUNOFF  (RESERVOIR)  (RES.-EFF)   (RESER.)   (RESER.)

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

    401.00        2          N/A       .00-     .00      .00       .00

   UNTREATED WATER CONC (MICROGRAMS/LITER (PPB)) Ver 1.1.0 DEC 12, 2005

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

        PEAK DAY  (ACUTE)      ANNUAL AVERAGE (CHRONIC)

          CONCENTRATION             CONCENTRATION

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

            100.613                     29.622

Appendix B  -  SCI-GROW OUTPUT FILE

SCIGROW

                          VERSION 2.3

            ENVIRONMENTAL FATE AND EFFECTS DIVISION

                 OFFICE OF PESTICIDE PROGRAMS

             U.S. ENVIRONMENTAL PROTECTION AGENCY

                        SCREENING MODEL

                FOR AQUATIC PESTICIDE EXPOSURE

 SciGrow version 2.3

 chemical:Boscalid

 time is  8/27/2003   8:58:12

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

  Application      Number of       Total Use    Koc      Soil Aerobic

  rate (lb/acre)  applications   (lb/acre/yr)  (ml/g)   metabolism (days)

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

      0.350           6.0           2.100      8.21E+02      407.5

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

 groundwater screening cond (ppb) =   6.34E-01

 ***********************************************************************

 PAGE

 PAGE   1

OFFICE OF

PREVENTION, PESTICIDES AND

TOXIC SUBSTANCES


[Federal Register: February 25, 2011 (Volume 76, Number 38)]
[Notices]
[Page 10581]
[DOCID:fr25fe11-48]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

 [Docket No. PR11-87-000]

Moss Bluff Hub, LLC; Notice of Filing

    Take notice that on February 11, 2011, Moss Bluff Hub, LLC filed to
revise its Statement of General Terms and Standard Operating Conditions
to reflect the addition of Bobcat Gas Storage to the list of entities
whose service agreements constitute a Valid Service Agreement as more
fully described in the filing.
    Any person desiring to participate in this rate 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 on or before the date as indicated below. 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 7 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>.
    Comment Date: 5 p.m. Eastern Time on Friday, February 25, 2011.

    Dated: February 17, 2011.
Kimberly D. Bose,
Secretary.
[FR Doc. 2011-4260 Filed 2-24-11; 8:45 am]
BILLING CODE 6717-01-P