[Federal Register Volume 79, Number 213 (Tuesday, November 4, 2014)]
[Notices]
[Pages 65468-65471]
[FR Doc No: 2014-26122]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-73461; File No. SR-BYX-2014-029]

Self-Regulatory Organizations; BATS Y-Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change Related to
Fees for Use of BATS Y-Exchange, Inc.

October 29, 2014.
    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 October 24, 2014, BATS Y-Exchange, Inc. (the ``Exchange'' or
``BYX'') 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 the
Substance of the Proposed Rule Change

    The Exchange filed a proposal to amend the fee schedule applicable
to Members \3\ and non-members of the Exchange pursuant to BYX Rules
15.1(a) and (c). Changes to the fee schedule pursuant to this proposal
are effective upon filing.
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    \3\ A Member is defined as ``any registered broker or dealer
that has been admitted to membership in the Exchange.'' See Exchange
Rule 1.5(n).
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    The text of the proposed rule change is available at the Exchange's
Web site at http://www.batstrading.com/, 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 parts of such
statements.

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

1. Purpose
    The Exchange proposes to modify its fee schedule effective
immediately in order to adopt pricing charged by the Exchange for
Supplemental Peg Orders, as defined in Rule 11.9(c)(19), and several
new routing strategies, as described below.
Supplemental Peg Orders
    The Exchange recently adopted a new order type, the Supplemental
Peg Order, which is a non-displayed limit order described in Rule
11.9(c)(19). The Exchange proposes to modify its fee schedule to make
clear that standard pricing for all other types of Non-Displayed
Liquidity, as defined in the fee schedule, applies to Supplemental Peg
Orders. Thus, the Exchange proposes to charge $0.0024 per share for all
Supplemental Peg Orders executed on the Exchange that add liquidity in
securities priced $1.00 and above. As with all orders adding liquidity
to the Exchange, Supplemental Peg Orders in securities priced below
$1.00 would not receive a liquidity rebate.
Routing Strategies
    The Exchange recently filed a proposed rule change to adopt several
new routing options in connection with the Exchange's technology
integration with EDGA Exchange, Inc. (``EDGA'') and EDGX Exchange, Inc.
(``EDGX'').\4\ The Exchange proposes to adopt pricing for the new
routing options, as set forth below, and also proposes various
structural changes to the fee schedule.
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    \4\ See Securities Exchange Act Release No. 73411 (October 23,
2014) (SR-BYX-2014-028), available at http://www.sec.gov/rules/sro/byx.shtml.
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    First, the Exchange adopted two new routing strategies that are
similar to the Exchange's existing standard best execution routing
strategies. Specifically, the Exchange adopted ROUT and ROUX, which are
similar to Parallel D and Parallel 2D. Accordingly, the Exchange
proposes to charge the same fee for ROUT and ROUX routed executions as
it does for Parallel D and Parallel 2D routing strategies.
Specifically, the Exchange proposes to charge $0.0029 per share for
orders in securities priced $1.00 and above executed through ROUT and
ROUX at a venue other than a dark liquidity venue (i.e., through DRT
routing). As it does currently, any execution through DRT routing at a
dark liquidity venue will continue to be charged $0.0020 per share.
Because DRT routing can be combined with various other new routing
strategies set forth below, the Exchange also proposes to modify the
description in the ``Other Non-Standard Routing Options'' section of
the fee schedule to explicitly state that any liquidity removed through
DRT at a venue other than through the SLIM routing strategy is $0.0020
per share (SLIM currently charges $0.0027 for executions at dark
liquidity venues). This reflects an expansion of the current provision
that applies a rate of $0.0020 per share for BYX + DRT Destination
Specific Orders to apply that same rate to all executions that remove
liquidity at a dark liquidity venue. In addition, to conform to the fee
charged for Parallel D and Parallel 2D routed executions in securities
priced below $1.00, the Exchange proposes to charge a fee that is 0.29%
of the total dollar value for any execution of a ROUT or ROUX routed
order in securities priced below $1.00.
    Second, the Exchange adopted various new strategies that are
similar (but not identical) to existing Destination Specific routing
offered by the Exchange. The Exchange proposes to conform such new
strategies with

pricing for the similar existing strategies as set forth below. For
instance, the Exchange adopted two new routing strategies that can
remove liquidity specifically targeted at NYSE, RDOT and RDOX. The
Exchange proposes to charge the same fee of $0.0026 per share for RDOT
and RDOX routed executions at NYSE as it does for Destination Specific
executions at NYSE. The Exchange also adopted the INET routing
strategy, which is specifically targeted at NASDAQ. The Exchange
proposes to charge the same fee of $0.0029 per share for INET routed
executions at NASDAQ as it does for Destination Specific executions at
NASDAQ. Finally, the Exchange adopted the ROLF routing strategy, which
is specifically targeted at the LavaFlow ECN. The Exchange proposes to
charge the same fee for ROLF as it does for all Destination Specific
routing at venues not included in the Exchange's One Under/Better
Program (where the Exchange seeks to improve by $0.0001 per share the
fee charged or rebate provided by each venue in the program). Thus, the
Exchange proposes to charge $0.0030 per share for any ROLF routed
execution at LavaFlow ECN.
    Third, the Exchange adopted the new Post to Away routing strategy,
which, for the first time on the Exchange, can result in the Exchange
routing an order to an away venue to be posted to such venue. In
addition to the Post to Away routing strategy, the RDOT, RDOX and INET
routing strategies can also post at away venues. The Exchange proposes
to adopt the following pricing for executions in securities priced
$1.00 and above through these routing strategies: (1) Add liquidity at
BZX through Post to Away routing: $0.0020 rebate per share; (2) add
liquidity at EDGX through Post to Away routing: $0.0020 rebate per
share; (3) add liquidity at EDGA through Post to Away routing: $0.0005
charge per share; (4) add liquidity at NYSE through Post to Away, RDOT
or RDOX routing: $0.0015 rebate per share; (5) add liquidity at NYSE
ARCA through Post to Away routing for Tape B: $0.0022 rebate per share;
(6) add liquidity at NYSE ARCA through Post to Away routing for Tapes A
and C: $0.0021 rebate per share; (7) add liquidity at NYSE MKT through
Post to Away routing: $0.0015 rebate per share; (8) add liquidity at
NASDAQ through Post to Away or INET routing: $0.0015 rebate per share;
(9) add liquidity at NASDAQ BX through Post to Away routing: $0.0020
charge per share. Each of the proposed fees and rebates set forth above
is equal to or roughly equivalent to the standard fee or rebate (i.e.,
without taking any potential tiered pricing into account) that will be
charged or provided pursuant to the applicable exchange's fee schedule.
More importantly, the Exchange notes that these are the same fees and
rebates charged and provided by the Exchange's affiliates, EDGA and
EDGX, for identical routing strategies that post to away market venues.
Accordingly, the Exchange is seeking to conform to such pricing
schedules. In addition to standard pricing set forth above, the
Exchange proposes to provide executions through the RDOT, RDOX, INET,
and Post to Away routing strategies that post to away markets in
securities priced below $1.00 without any fee or rebate, as this is the
pricing structure in place at many of the away venues where orders can
be routed and provides for a simplistic pricing model.
    Fourth, the Exchange notes that although orders sent through each
of the routing strategies described in the preceding paragraph can
provide liquidity on away market venues, such strategies can also
result in orders removing liquidity. Accordingly, the Exchange proposes
to adopt fees for orders that remove liquidity through such routing
strategies. For orders that remove liquidity through Post to Away
routing, the Exchange proposes to charge the same fees that have been
proposed for ROUT and ROUX routed executions. Specifically, the
Exchange proposes to charge $0.0029 per share for orders in securities
priced $1.00 and above that are routed by the Exchange through the Post
to Away routing strategy and remove liquidity. The Exchange also
proposes a fee that is 0.29% of the total dollar value for any
execution of a Post to Away routed order in securities priced below
$1.00 that removes liquidity. The Exchange also has adopted new routing
strategies that can send orders to the NYSE that can, in turn, be re-
routed by the NYSE. For each of these routing strategies, RDOT, RDOX
and Post to Away, the Exchange proposes to adopt a fee of $0.0030 per
share for any execution of an order that has been re-routed by NYSE.
    Fifth, the Exchange adopted the ICMT and IOCM routing strategies,
each of which may route an order to EDGX as a MidPoint Match order. The
Exchange proposes to adopt pricing identical to the Exchange's existing
RMPT routing strategy for both ICMT and IOCM. As is true for RMPT, the
proposed fees for ICMT and IOCM are intended to approximate the cost
for executions of midpoint orders on away trading venues. For orders
routed pursuant to the ICMT or IOCM routing strategy and executed on an
away trading venue, the Exchange proposes to charge $0.0012 per share
in securities priced at or above $1.00 and 0.29% of the total dollar
value of the execution for securities priced below $1.00.
    Finally, the Exchange notes that it has proposed stylistic and
corrective changes throughout the fee schedule. For instance, because
the Exchange is adopting routing strategies that will now add liquidity
to away market venues, the Exchange has proposed to include language
throughout its routing fees stating whether an order adds or removes
liquidity through such strategy. Similarly, in certain places where
routing strategies referred to specific orders or order types rather
than routing strategies, the Exchange has modified the description,
which is consistent with its recent routing filing.\5\ The Exchange has
also proposed to eliminate references to the CYCLE and RECYCLE routing
strategies. The Exchange no longer offers the CYCLE routing strategy
and has eliminated such routing strategy from its rules. Similarly, the
Exchange recently updated its rules to rename the RECYCLE strategy as
Re-Route. However, the Exchange proposes to omit reference to Re-Route
from its fee schedule (other than orders ``re-routed'' by NYSE, as
described above) rather than to replace RECYCLE with Re-Route. Orders
that have been routed to away market centers through a routing strategy
offered by the Exchange that are posted to the Exchange's order book
and subject to the Re-Route option may be routed away from the Exchange
again pursuant to Rule 11.13(a)(4). The Exchange maintains the routing
strategy instruction on an order when re-routing pursuant to the Re-
Route option, and thus, charges the fee related to such routing
strategy rather than to apply a specific ``Re-Route'' fee. In addition
to these changes, the Exchange has proposed various additional
stylistic changes, such as eliminating quotation marks and other minor
word changes.
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    \5\ See id.
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    The Exchange proposes to implement the amendments to its fee
schedule effective immediately.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the requirements of the Act and the rules and regulations
thereunder that are applicable to a national securities exchange, and,
in particular, with the requirements of Section 6 of the Act.\6\
Specifically, the Exchange believes that the proposed rule change is
consistent

with Sections 6(b)(4) of the Act and 6(b)(5) of the Act,\7\ in that it
provides for the equitable allocation of reasonable dues, fees and
other charges among members and other persons using any facility or
system which the Exchange operates or controls. The Exchange notes that
it operates in a highly competitive market in which market participants
can readily direct order flow to competing venues if they deem fee
levels at a particular venue to be excessive.
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    \6\ 15 U.S.C. 78f.
    \7\ 15 U.S.C. 78f(b)(4) and (5).
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    The Exchange believes that the proposed fee to add liquidity
through use of Supplemental Peg Orders is reasonable and equitable
because it is the same fee charged for most other types of non-
displayed liquidity (with the exception of Mid-Point Peg orders). The
Exchange does not currently believe that there is any reason to
differentiate Supplemental Peg Orders from other types of non-displayed
liquidity. The Exchange also believes that its proposed fee for
Supplemental Peg Orders is non-discriminatory because it applies
uniformly to all Members, and again, is based on existing pricing for
similar orders.
    The Exchange believes that the proposed changes to the Exchange's
fee schedule to add fees for the ROUT and ROUX routing strategies
represent a reasonable and equitable allocation of fees because they
are identical to the fees charged for executions through similar
routing strategies offered by the Exchange, namely Parallel D and
Parallel 2D. The Exchange further believes that the proposed fees for
ROUT and ROUX are non-discriminatory because they apply uniformly to
all Members, and again, are based on existing pricing for similar
orders. Similarly, the Exchange believes that expansion of standard DRT
pricing of $0.0020 per share for all executions at a dark liquidity
venue other than through SLIM routing is reasonable and equitable
because it is consistent with existing pricing for executions at dark
liquidity venues. In addition, the Exchange believes that this pricing
is non-discriminatory because it applies uniformly to all Members and
is based on existing DRT routing pricing.
    The Exchange believes that the proposed changes to the Exchange's
fee schedule to add fees for RDOT, RDOX, INET and ROLF routing
strategies when removing liquidity represent a reasonable and equitable
allocation of fees because they are identical to the fees charged for
executions through similar routing strategies offered by the Exchange,
namely Destination Specific orders to each applicable venue (i.e., NYSE
for RDOT and RDOX, NASDAQ for INET and LavaFlow ECN through ROLF). The
Exchange further believes that the proposed fees for RDOT, RDOX, INET
and ROLF are non-discriminatory because they apply uniformly to all
Members, and again, are based on existing pricing for similar orders.
    The Exchange also believes that its proposed pricing for Post to
Away routing strategies that add liquidity in securities priced $1.00
and above are reasonable and equitable because they are equal to or
roughly equivalent to the standard fee or rebate that will be charged
or provided pursuant to the applicable exchange's fee schedule and are
identical to the same fees and rebates charged and provided by the
Exchange's affiliates, EDGA and EDGX, for identical routing strategies
that post to away market venues. The Exchange also believes that its
proposed pricing for Post to Away routing strategies that add liquidity
in securities priced below $1.00 (i.e., no fee or rebate) is reasonable
and equitable because most away venues charge no fee and provide no
rebate for such orders. The Exchange further believes that the proposed
fees and rebates for Post to Away are non-discriminatory because they
apply uniformly to all Members and, again, because they approximate the
fee or rebate at the away venue.
    The Exchange also believes that its proposed fees for orders that
remove liquidity when sent through the Post to Away routing is
reasonable and equitable because it is identical to that proposed for
ROUT and ROUX, and is thus, equivalent to the Exchange's standard
routing fees. The Exchange further believes that a slightly higher fee
for orders re-routed by NYSE through the RDOT, RDOX and Post to Away
routing strategies are is [sic] reasonable as it is the same fee
charged by NYSE for routing. The Exchange again believes that its
proposed fees are non-discriminatory in that they apply uniformly to
all Members and are intended to generally approximate routing costs
and/or to align with existing routing pricing.
    The Exchange believes that the proposed changes to the Exchange's
fee schedule to add fees for the IOCM and ICMT routing strategies
represent an equitable allocation of reasonable dues, fees, and other
charges among Members and other persons using its facilities because
they are in line with the fees charged for executions through other
low-price routing strategies and approximate the cost to the Exchange
of executing midpoint orders on away trading venues. Lastly, the
Exchange believes that the proposed pricing for the IOCM and ICMT
routing strategies is non-discriminatory because it applies uniformly
to all Members.
    Finally, the Exchange believes that the additional clarifications,
stylistic changes, and elimination of reference to CYCLE and RECYCLE
proposed by the Exchange are consistent with the Act as they will
enhance the readability and clarity of the fee schedule.

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
result in any burden on competition that is not necessary or
appropriate in furtherance of the purposes of the Act, as amended. The
Exchange reiterates that the Supplemental Peg Order will be treated
similar to most other non-displayed liquidity on the Exchange (other
than Mid-Point Peg orders). Also, because the market for order
execution is extremely competitive, Members may readily opt to disfavor
the Exchange's routing services if they believe that alternatives offer
them better value. For orders routed through the routing strategies
adopted by the Exchange, the proposed fees are in line with the fees
charged for executions through other routing strategies offered by the
Exchange and approximate the cost to the Exchange of executing midpoint
orders on away trading venues. As stated above, the Exchange notes that
it operates in a highly competitive market in which market participants
can readily direct order flow to competing venues if the deem fee
structures to be unreasonable or excessive.

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 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 \8\ and paragraph (f) of Rule 19b-4
thereunder.\9\ 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.
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    \8\ 15 U.S.C. 78s(b)(3)(A).
    \9\ 17 CFR 240.19b-4(f).
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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-BYX-2014-029 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-BYX-2014-029. 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 such 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-BYX-2014-029, and should be
submitted on or before November 25, 2014.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\10\
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    \10\ 17 CFR 200.30-3(a)(12).
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Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-26122 Filed 11-3-14; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 87, Number 76 (Wednesday, April 20, 2022)]
[Notices]
[Pages 23522-23523]
[FR Doc No: 2022-08460]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-0001]

Science Advisory Board to the National Center for Toxicological
Research Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) announces a
forthcoming public advisory committee meeting of the Science Advisory
Board to the National Center for Toxicological Research. The general
function of the committee is to provide advice and recommendations to
the Agency on research being conducted at the National Center for
Toxicological Research (NCTR). At least one portion of the meeting will
be closed to the public.

DATES: The meeting will be held virtually on May 18, 2022, from 8 a.m.
to 5:55 p.m., Central Standard Time, and on May 19, 2022, from 8 a.m.
to 11:30 a.m., Central Standard Time.

ADDRESSES: Please note that due to the impact of this COVID-19
pandemic, all meeting participants will be joining this advisory
committee meeting via an online teleconferencing platform. Answers to
commonly asked questions about FDA advisory committee meetings may be
accessed at: https://www.fda.gov/advisory-committees/about-advisory-committees/common-questions-and-answers-about-fda-advisory-committee-meetings. The meeting will be webcast both days and will be available
at the following link: https://fda.zoomgov.com/j/1605634800?pwd=QWlpWUpZUnZTVnZWWUIwckxMRVdZUT09.

    Passcode: N5v5y*

FOR FURTHER INFORMATION CONTACT: Donna Mendrick, National Center for
Toxicological Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 32, Rm. 2208, Silver Spring, MD 20993-0002, 301-
796-8892, or FDA Advisory Committee Information Line, 1-800-741-8138
(301-443-0572 in the Washington, DC area). A notice in the Federal
Register about last minute modifications that impact a previously
announced advisory committee meeting cannot always be published quickly
enough to provide timely notice. Therefore, you should always check the
Agency's website at https://www.fda.gov/AdvisoryCommittees/default.htm
and scroll down to the appropriate advisory committee meeting link, or
call the advisory committee information line to learn about possible
modifications before coming to the meeting.

SUPPLEMENTARY INFORMATION:
    Agenda: On May 18, 2022, the Science Advisory Board Chair will
welcome the participants, and the NCTR Director will provide a Center-
wide update on scientific initiatives and accomplishments during the
past year. The Science Advisory Board will be presented with an
overview of the Science Advisory Board Subcommittee Site Visit Report
and a response to this review. The Center for Biologics Evaluation and
Research, Center for Drug Evaluation and Research, Center for Devices
and Radiological Health, Center for Food Safety and Applied Nutrition,
Center for Tobacco Products, and the Office of Regulatory Affairs will
each briefly discuss their specific research strategic needs and
potential areas of collaboration.
    On May 19, 2022, there will be updates from the NCTR Research
Divisions and a public comment session. Following an open discussion of
all the information presented, the open session of the meeting will
close so the Science Advisory Board members can discuss personnel
issues at NCTR.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its website prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's website after the meeting. Background material is
available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link.
    Procedure: On May 18, 2022, from 8 a.m. to 5:55 p.m., Central
Standard Time, and May 19, 2022, from 8 a.m. to 11:30 a.m., Central
Standard Time, the meeting is open to the public. Interested persons
may present data, information, or views, orally or in writing, on
issues pending before the committee. Written submissions may be made to
the contact person on or before May 13, 2022. Oral presentations from
the public will be scheduled between approximately 1 p.m. and 2 p.m.
Central Standard Time. Those individuals interested in making formal
oral presentations should notify the contact person and submit a brief
statement of the general nature of the evidence or arguments they wish
to present, the names and addresses of proposed participants, and an
indication of the approximate time requested to make their presentation
on or before May 5, 2022. Time allotted for each presentation may be
limited. If the number of registrants requesting to speak is greater
than can be reasonably accommodated during the scheduled open public
hearing session, FDA may conduct a lottery to determine the speakers
for the scheduled open public hearing session. The contact person will
notify interested persons regarding their request to speak by May 6,
2022.
    Closed Committee Deliberations: On May 19, 2022, from 11:30 a.m. to
12 p.m., Central Standard Time, the meeting will be closed to permit
discussion where disclosure would constitute a clearly unwarranted
invasion of personal privacy (5 U.S.C. 552b(c)(6)). This portion of the
meeting will be closed to permit discussion of information concerning
individuals associated with the research programs at NCTR.
    Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
disabilities. If you require accommodations due to a disability, please
contact Donna Mendrick at least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our website at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: April 15, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-08460 Filed 4-19-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: December 7, 2005 (Volume 70, Number 234)]
[Notices]
[Page 72813-72814]
[DOCID:fr07de05-61]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP03-323-009]

Williston Basin Interstate Pipeline Company; Notice of Negotiated
Rate

November 29, 2005.
    Take notice that on November 21, 2005, Williston Basin Interstate
Pipeline Company (Williston Basin), tendered for filing with the
Commission a negotiated Rate Schedule FT-1 Service Agreement. Williston
Basin states that the proposed effective date of the Service Agreement
is the date the Conoco Refinery-Billings delivery point is placed into
service.
    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>.

Magalie R. Salas,
Secretary.
[FR Doc. E5-6942 Filed 12-6-05; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 84, Number 113 (Wednesday, June 12, 2019)]
[Proposed Rules]
[Pages 27212-27215]
[FR Doc No: 2019-12412]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R05-OAR-2018-0072; FRL-9995-13-Region 5]

Air Plan Approval; Illinois; Sulfur Dioxide

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve a request submitted by the Illinois Environmental Protection
Agency (IEPA) on February 6, 2018 to revise the Illinois State
Implementation Plan (SIP) under the Clean Air Act (CAA) for the 2010
sulfur dioxide (SO2) National Ambient Air Quality Standard
(NAAQS). IEPA is specifically requesting EPA approval to amend
Illinois' SIP for the 2010 SO2 NAAQS to account for two
variances recently granted by the Illinois Pollution Control Board
(IPCB) to Calpine Corporation (Calpine) and Exelon Generation, LLC
(Exelon).

DATES: Comments must be received on or before July 12, 2019.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R05-
OAR-2018-0072 at http://www.regulations.gov, or via email to
<EMAIL_ADDRESS>For comments submitted at Regulations.gov,
follow the online instructions for submitting comments. Once submitted,
comments cannot be edited or removed from Regulations.gov. For either
manner of submission, EPA may publish any comment received to its
public docket. Do not submit electronically any information you
consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Multimedia
submissions (audio, video, etc.) must be accompanied by a written
comment. The written comment is considered the official comment and
should include discussion of all points you wish to make. EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e., on the web, cloud, or other file sharing
system). For additional submission methods, please contact the person
identified in the FOR FURTHER INFORMATION CONTACT section. For the full
EPA public comment policy, information about CBI or multimedia
submissions, and general guidance on making effective comments, please
visit http://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Francisco J. Acevedo, Mobile Source
Program Manager, Control Strategies Section, Air Programs Branch (AR-
18J), Environmental Protection Agency, Region 5, 77 West Jackson
Boulevard, Chicago, Illinois 60604,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we,''
``us,'' or ``our'' is used, we mean EPA. This SUPPLEMENTARY INFORMATION
section is arranged as follows:

I. What is the background for this action?
II. What changes have been made as part of the SIP revision?
III. What is EPA's analysis of the state's submittal?
IV. What action is EPA taking?
V. Incorporation by Reference
VI. Statutory and Executive Order Reviews

I. What is the background for this action?

    On June 22, 2010, EPA promulgated a new 1-hour primary
SO2 NAAQS of 75 parts per billion (ppb), which is met at an
ambient air quality monitoring site when the 3-year average of the
annual 99th percentile of 1-hour daily maximum concentrations does not
exceed 75 ppb, as determined in accordance with appendix T of 40 CFR

part 50. See 75 FR 35520, codified at 40 CFR 50.17(a)-(b). On August 5,
2013, EPA designated a first set of 29 areas of the country as
nonattainment for the 2010 SO2 NAAQS, including the Lemont
and Pekin areas within Illinois. See 78 FR 47191, codified at 40 CFR
part 81, subpart C. These area designations were effective October 4,
2013. More recently, on July 12, 2016, EPA designated the Alton
Township area (including part of Madison County) and the Williamson
County area as additional nonattainment areas for the 2010
SO2 NAAQS in Illinois. See 81 FR 45039. These area
designations were effective September 12, 2016.
    In conjunction with its adoption of SO2 emission limits
for major sources, Illinois adopted rule revisions (Sulfur Content
Rule) to limit the sulfur content of distillate and residual fuel oil
combusted at stationary sources throughout the state. See 35 Ill. Adm.
Code 214.161(b)(2) and 214.305(a)(2). The Sulfur Content Rule
specifically requires that the sulfur content of distillate fuel oil
combusted on or after January 1, 2017, not exceed 15 parts per million
(ppm). The rule applies to owners and operators of existing fuel
combustion emission and process emission sources that burn liquid fuel.
Consistent with trends toward increasing availability and use of lower
sulfur oil of all kinds, these limits were intended to assure that the
considerable number of generally smaller boilers that burn these fuels
use fuels with relatively low sulfur content.
    Rather than imposing fuel sulfur content limitations piecemeal as
additional areas are designated nonattainment, the IEPA proposed
establishing such limits statewide. The new limits adopted by Illinois
are intended to help protect air quality in the entire state, including
the Alton Township, Lemont, Pekin, and Williamson County nonattainment
areas. The limits will also assist Illinois' attainment planning
efforts in future nonattainment areas and could potentially help
certain areas avoid a nonattainment designation.
    Illinois' Sulfur Content Rule, containing 35 Ill. Adm. Code
214.161(b)(2) and 214.305(a)(2), was submitted to EPA as a SIP revision
on March 2, 2016, and the EPA issued an approval in the Federal
Register on February 1, 2018 (83 FR 4591) and May 29, 2018 (83 FR
24406).

II. What changes have been made as part of the SIP revision?

    Exelon maintains a series of diesel fuel storage tanks at four of
its nuclear generation stations for fuel that powers equipment in the
event of an emergency or loss of power. The facilities must always keep
a specified volume of diesel fuel on hand to power the emergency
equipment and ensure nuclear safety. However, the amount of fuel
actually used is low because the use of the fuel for anything other
than emergencies and readiness testing is prohibited. This results in a
large amount of fuel with sulfur content greater than 15 ppm being
stored for long periods of time. The four stations currently have 47
emergency fuel tanks with over 700,000 gallons of diesel fuel
containing sulfur ranging from 19 ppm to 211 ppm.
    On May 18, 2016, Exelon filed a Petition for Variance with the IPCB
regarding its Byron (Ogle County), Clinton (DeWitt County), Dresden
(Grundy County), and LaSalle (LaSalle County) nuclear generation
stations. See Exelon Generation, LLC v. Illinois Environmental
Protection Agency, PCB 16-106. Exelon requested relief from the 15 ppm
sulfur content limitation for distillate fuel oil set forth in 35 Ill.
Adm. Code 214.161(b)(2). On September 8, 2016, the IPCB granted the
variance from January 1, 2017, to December 31, 2019, for the Byron and
Dresden stations, subject to certain conditions; from January 1, 2017,
to December 31, 2020, for the Clinton station, subject to certain
conditions; and from January 1, 2017, to December 31, 2021, for the
LaSalle station, subject to certain conditions.
    Calpine owns three simple-cycle natural gas fired turbines with
distillate oil as back up fuel to generate electricity in Zion,
Illinois (known as ``Zion Energy Center''). The Zion Energy Center is a
``peaker'' plant that only operates when electricity demand is high.
Each turbine at the Zion Energy Center is equipped with dry low
NOX combustors for natural gas firing and water injection
for oil firing. The Zion Energy Center also maintains a supply of
distillate oil to burn when it cannot access natural gas. The facility
currently has 960,000 gallons of distillate oil with a sulfur content
of 113 ppm, a mixture of ultra-low sulfur fuel (at or below 15 ppm) and
fuel with higher sulfur content.
    On June 16, 2016, Calpine filed a Petition for Variance with the
IPCB regarding the Zion Energy Center. See Calpine Corporation (Zion
Energy Center) v. Illinois Environmental Protection Agency, PCB 16-112.
On August 8, 2016, Calpine filed an Amended Petition for a Variance
with the IPCB, requesting relief from the 15 ppm sulfur content
limitation for distillate fuel oil set forth in 35 Ill. Adm. Code
214.161(b)(2). On November 17, 2016, the IPCB granted the variance from
January 1, 2017, to December 31, 2021, subject to certain conditions.
    On August 3, 2017, Calpine filed a Motion to Administratively Amend
the IPCB's Order Granting a Variance to amend the IPCB's final order by
replacing references to 35 Ill. Adm. Code 214.161(b)(2), which applies
to fuel combustion emission units, with references to 35 Ill. Adm. Code
214.305(a)(2), which applies to process emission units, as the units
subject to the variance are actually process emission units. The IPCB
granted the motion on August 17, 2017, amending its order to correct
the errors.
    Since the petitions for variance sought relief from provisions that
were approved into the Illinois SIP, such variances must be submitted
to EPA for approval as SIP revisions. None of the facilities addressed
in the Exelon and Calpine variances are located in or near existing
SO2 nonattainment areas.

III. What is EPA's analysis of the state's submittal?

    Our primary consideration for determining the approvability of
Illinois' revision is whether approval of the Exelon and Calpine
variances to the SO2 SIP comply with the SO2
NAAQS.
    EPA can approve a SIP revision that modifies control measures in
the SIP once the state makes a demonstration that such modification
will not interfere with attainment of the NAAQS, or any other CAA
requirement.

Exelon Variance

    Exelon considered four potential options to comply with the Sulfur
Content Rule as of January 1, 2017. Such options included combusting
all of the noncompliant fuel; continuing to dilute the fuel's sulfur
content concentrations with ultra-low sulfur diesel (ULSD); draining
all of the storage tanks and refilling them with ULSD; or draining and
refilling on the larger tanks. For the proposed SIP revision, Exelon
has demonstrated that none of the four compliance alternatives
evaluated were practicable for meeting the 15 ppm sulfur limit by
January 1, 2017 and presented a substantial hardship to the company.
    Exelon explains that the facilities are required to maintain large
volumes of diesel fuel to power emergency generators, auxiliary boilers
(at two of the facilities), and fire pumps, equipment that Exelon
collectively refers to as its ``Emergency Equipment.'' The Nuclear
Regulatory Commission (NRC) requires that the facilities maintain this
equipment to be used in emergency situations, such as during

power losses. See 10 CFR 50.63. The NRC also requires that the
Emergency Equipment be maintained in a condition that will ensure they
will startup and provide emergency power when called upon at a high
degree of readiness. Exelon explains that this ``availability''
requirement limits the amount of time Exelon can perform preventative
maintenance on the equipment and the associated fuel tanks.
    Exelon further explains that NRC regulations require that the
facilities store and maintain on-site enough fuel to power the
Emergency Equipment for up to seven days. Exelon indicates, if the
minimum inventory is not immediately available, the plant enters a
Limiting Condition for Operation (LCO) for the associated emergency
engines. This threatens the pertinent station's ability to meet
applicable availability and operability requirements, and if not
corrected within seven days, obligates the station to begin a
controlled shutdown of the affected nuclear reactor.
    Exelon indicates that the federally enforceable state operating
permits (FESOPs) for the facilities restrict the usage of, and
emissions from, the Emergency Equipment. Similarly, some of the
equipment is subject to Federal New Source Performance Standards (NSPS)
for ``Stationary Compression Ignition Internal Combustion Engines''
(NSPS IIII, 40 CFR 60.4200) and the National Emission Standards for
Hazardous Air Pollutants (NESHAP) for ``Stationary Reciprocating
Internal Combustion Engines'' (Maximum Achievable Control Technology
(MACT) ZZZZ, 40 CFR 63.6580), which also restrict the amount of time
the Emergency Equipment can be operated.
    Exelon explains that, in 2007 for the Byron, Dresden, and LaSalle
Stations and in 2010 for the Clinton Station, it began purchasing only
ultra-low sulfur fuel (i.e., fuel with sulfur content no greater than
15 ppm) to replenish any fuel depleted from the pertinent diesel fuel
storage tanks. While this has resulted in the dilution of the sulfur
content of the stored fuel, recent sampling of a representative number
of tanks at the facilities indicates that there is fuel in the system
that currently remains above 15 ppm.
    Exelon's plan for complying with the Sulfur Content Rule by the end
of the variance period outlined by the IPCB calls for continuing to
replenish the lower sulfur tanks with ULSD; and, as part of a
coordinated program, emptying the higher sulfur tanks and refiling them
with ULSD.
    Using sulfur concentrations equal to those from current tank
samples at the facilities, Exelon estimates that it would emit a total
of 0.481 more tons of SO2 under the variance than if it
timely complied with the Sulfur Content Rule. As Exelon replenishes the
emergency tanks with ULSD, sulfur concentrations in the fuel will be
reduced over time. Taking this dilution into account and using annual
averages for fuel burned over the last five years, the estimated
SO2 emissions with the variance are 0.067 more ton per year
than with compliant fuel. As the variance relief would last from three
to five years, depending on the station, Exelon estimates that it would
emit a total of 0.26 ton more of SO2 under the variance than
if it timely complied with the Sulfur Content Rule.
    IEPA does not believe that any injury to the public or environment
will result from granting the variance. None of the facilities are in
an SO2 nonattainment area, and the estimated SO2
emissions increase is negligible and extremely unlikely to impact an
SO2 nonattainment area. Further, IEPA has examined the
locations of these facilities in comparison to areas currently being
investigated and modeled for future area designation recommendations
and determined that there is no overlap; IEPA therefore does not
believe that the facilities will impact potential future nonattainment
areas.

Calpine Variance

    Calpine considered two potential options for immediate compliance
with the Sulfur Content Rule. Such options included combusting all of
its distillate oil before January 1, 2017; and draining the fuel from
the storage tanks. For the proposed SIP revision, Calpine demonstrated
that none of the compliance alternatives evaluated were practicable for
meeting the 15 ppm sulfur limit by January 1, 2017 and presented a
substantial hardship to the company.
    Calpine argued that it cannot combust all of its distillate oil
without violating its Clean Air Act Permit Program (CAAPP) permit that
was reissued on October 16, 2014 (ID NO. 097200ABB, Application No.
99110042). Under its permit, the facility may only combust distillate
oil for limited purposes including when natural gas is unavailable or
for shakedown, evaluation, and testing of the turbines. Calpine alleges
that because the facility's turbines are expensive to operate,
electricity grid operators only direct the Zion Energy Center to
generate electricity when demand is high, such as during extreme
weather conditions. Therefore, the facility's permit and economic
conditions prevented burning the entire supply of the distillate oil
supply before January 1, 2017. Additionally, Calpine also argues that
draining the storage tanks would impose a substantial hardship.
Draining the tanks would entail purchasing and installing new equipment
and revising facility plans that safeguard fuel spills at a substantial
cost. Furthermore, Calpine alleges that it is contractually obligated
to maintain 12 hours of backup fuel in case of emergency, so draining
the tanks would violate this obligation and risk public safety. Based
on Calpine's argument, the IPCB and IEPA both determined that Calpine
would suffer a substantial hardship if required to immediately comply
with the Sulfur Content Rule.
    Under Calpine's compliance plan, the facility would comply with the
Sulfur Content Rule by January 1, 2022 by continuing to purchase only
fuel with sulfur content below 15 ppm. This ensures that the sulfur
content of the fuel used at the facility will continue to decrease.
During the variance period, the sulfur content of all distillate oil
combusted by Calpine must not exceed 115 ppm sulfur content.
    Calpine alleges that with its existing supply of distillate oil,
its turbines can operate for approximately 68.6 hours (or approximately
22.8 hours of operation for each of the three turbines). With the
proposed maximum sulfur content of 115 ppm for distillate oil, this
operation would emit a total of 0.77 tons of SO2 over the
five-year term of the variance, or 0.15 tons per year (tpy). Under
compliance with the Sulfur Content Rule (using only 15 ppm distillate
oil), 68.6 hours of operation would yield a total of 0.10 tons of
SO2 emissions, or 0.02 tpy. Therefore, Calpine estimates
that it would emit a total of 0.67 ton more of SO2 under the
variance than if it timely complied with the Sulfur Content Rule.
    IEPA does not believe that any injury to the public or environment
will result from granting the Calpine variance. The Zion Energy Center
is not located in an SO2 nonattainment area, and the
estimated SO2 emissions increase is negligible and extremely
unlikely to impact an SO2 nonattainment area. Further, IEPA
has evaluated air dispersion modeling submitted by Calpine that
demonstrates that even under a 115 ppm sulfur scenario, as outlined in
the variance, the facility will not cause a violation of the
SO2 NAAQS; IEPA therefore does not believe that the Facility
will impact potential future nonattainment areas.

Conclusion

    None of the facilities addressed in the SIP are in or near existing
SO2 nonattainment areas. EPA has no reason to believe that
Illinois' revision to the Illinois SO2 SIP will cause any
area in Illinois to become nonattainment for the SO2 NAAQS.
Based on the above discussion, EPA believes that the variances granted
by the IPCB will not interfere with attainment or maintenance of the
SO2 NAAQS in Illinois and would not interfere with any other
applicable requirement of the CAA, and thus, is approvable under CAA.

IV. What action is EPA taking?

    EPA is proposing to approve the revision to the Illinois SIP
submitted by the IEPA on February 6, 2018, because the variances
granted by the IPCB for Calpine and Exelon meet all applicable
requirements and would not interfere with reasonable further progress
or attainment of the SO2 NAAQS.

V. Incorporation by Reference

    In this rule, EPA is finalizing regulatory text that includes
incorporation by reference. In accordance with requirements of 1 CFR
51.5, EPA is finalizing the incorporation by reference of the IPCB
Opinion and Order of the Board (PCB 16-106) adopted on September 8,
2016, effective on September 13, 2016; and Opinion and Order of the
Board (PCB 16-112) adopted on November 17, 2016, effective on December
19, 2016 and subsequently amended on August 17, 2017. EPA has made, and
will continue to make, these documents generally available through
www.regulations.gov, and at the EPA Region 5 Office (please contact the
person identified in the FOR FURTHER INFORMATION CONTACT section of
this preamble for more information).

VI. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the CAA and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely approves state law as meeting Federal requirements and
does not impose additional requirements beyond those imposed by state
law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Orders
12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21,
2011);
     Is not expected to be an Executive Order 13771 (82 FR
9339, February 2, 2017) regulatory action because this action is not
significant under Executive Order 12866;
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where EPA or an Indian tribe has
demonstrated that a tribe has jurisdiction. In those areas of Indian
country, the rule does not have tribal implications and will not impose
substantial direct costs on tribal governments or preempt tribal law as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Sulfur oxides.

    Dated: June 3, 2019.
Cheryl L. Newton,
Acting Regional Administrator, Region 5.
[FR Doc. 2019-12412 Filed 6-11-19; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 76, Number 163 (Tuesday, August 23, 2011)]
[Notices]
[Pages 52669-52670]
[FR Doc No: 2011-21487]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0332]

Report on the Performance of Drug and Biologics Firms in
Conducting Postmarketing Requirements and Commitments; Availability;
Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability; correction.

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SUMMARY: The Food and Drug Administration (FDA) is correcting a notice
of availability that appeared in the Federal Register of August 4, 2011
(76 FR 47211). The Agency is required to report annually in the Federal
Register on the status of postmarketing requirements and commitments
required of, or agreed upon by, holders of approved drug and biological
products. The August 4, 2011, notice is the Agency's report on the
status of the studies and clinical trials that applicants have agreed
to, or are required to, conduct. The document was published with an
error. This document corrects that error.

FOR FURTHER INFORMATION CONTACT: Joyce A. Strong, Office of Policy and
Planning, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
32, rm. 3208, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In FR Doc. 2011-19806, appearing on page
47211 in the Federal Register of August 4, 2011, the following
correction is made:
    On page 47214, table 1 is corrected to read as follows:

     Table 1--Summary of Postmarketing Requirements and Commitments
                   [Numbers as of September 30, 2010]
------------------------------------------------------------------------
                                    NDA/ANDA (% of      BLA (% of Total
                                  Total PMR or % of    PMR or % of total
                                      total PMC)           PMC) \1\
------------------------------------------------------------------------
Number of open PMRs............  526                  149.
    On-schedule open PMRs (see   477 (91%)            131 (88%).
     table 2 of this document).
    Off-schedule open PMRs (see  49 (9%)              18 (12%).
     table 3 of this document).
Number of open PMCs \2\........  473                  307.
    On-schedule open PMCs (see   399 (84%)            236 (77%).
     table 4 of this document).
    Off-schedule open PMCs (see  74 (16%)             71 (23%).
     table 5 of this document).
------------------------------------------------------------------------
\1\ On October 1, 2003, FDA completed a consolidation of certain
  therapeutic products formerly regulated by CBER into CDER.
  Consequently, CDER now reviews many BLAs. Fiscal year statistics for
  postmarketing requirements and commitments for BLAs reviewed by CDER
  are included in BLA totals in this table.
\2\ The number of PMCs reported as open as of September 30, 2009, in the
  ``Report on the Performance of Drug and Biologics Firms in Conducting
  Postmarketing Requirements and Commitments'' notice published in the
  Federal Register on November 9, 2010 (75 FR 68802), inadvertently also
  included open PMRs. That error has been corrected for the current
  reporting period.

    Dated: August 17, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-21487 Filed 8-22-11; 8:45 am]
BILLING CODE 4160-01-P


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CORMETECH, INC. Environmental Technologies Treyburn Corporate Park 5000 International Drive Durham, NC 27712 ( 919) 620 3000 Fax ( 919) 620 3001 PRODUCTS & SERVICES: Design and manufacture of proven ceramic based extruded honeycomb catalysts for maximum efficiency in NOx removal from coal, oil, or gas fired stationary combustion systems; in house pilot testing capabilities to simulate customer's actual flue gas conditions, providing the most reliable data possible on actual catalyst performance; additional services include flow modeling analyses, on site installation supervision, follow up performance evaluations, and catalyst recycling.

CRI CATALYST COMPANY 16825 Northchase Drive, Suite 1110 Houston, TX 77060 ( 281) 874 2490 Fax ( 281) 874 2499 PRODUCTS: Low and high temperature SCR catalysts; VOC control catalysts; catalytic dioxin destruction systems.

CSM WORLDWIDE, INC. Diamondhead Building 269 Sheffield Street, Suite 1 Mountainside, NJ 07092 ( 908) 233 2882 Fax ( 908) 233 1064 Systems: absorption; carbon adsorption; catalytic oxidation; continuous emissions monitoring; fabric filter; low NOx burner; NSCR/ three way catalyst; odor control; reburn; SCR; thermal oxidation Components/ supplies: absorber towers; catalyst substrates; catalysts; control systems; ductwork; insulation/ lagging; pressure vessels Services: catalyst cleaning/ regeneration; catalyst testing; consulting; design; engineering; erection; general contracting; installation; maintenance and repair; permitting; rebuilds; solvent recovery DURR ENVIRONMENTAL 31285 Durr Drive P. O. Box 930459 Wixom, MI 48393 0459 ( 248) 668 5200 Fax ( 248) 926 6570 Systems: carbon adsorption, catalytic oxidation, odor control; thermal oxidizers, regenerative thermal oxidizers, solvent recovery, VOC concentrators Components/ supplies: control systems; ductwork; insulation/ lagging Services: design, engineering, erection, general contracting, installation, long term operating contracts, maintenance and repair; modeling, rebuilds, upgrades and performance enhancement ENGELHARD CORPORATION 101 Wood Ave Iselin, NJ 08830 0770 ( 732) 205 5000 Fax ( 732) 205 6146 Products and services: catalysts for VOC, CO and NOx abatement, halogenated VOC streams, sulfur laden VOC streams and ammonia abatement. Also, rotor concentrators, NSCR/ three way catalyst and SCR technologies. Certain products are available in both ceramic and metallic monolith.

EPCON INDUSTRIAL SYSTEMS P. O. Box 7060 The Woodlands, TX 77387 ( 936) 273 3300 Fax ( 936) 273 6500 Products and services: thermal oxidizers, ovens and finishing systems F. L. SMIDTH AIRTECH INC. 100 Glenborough Drive Houston, TX 77067 3611 ( 713) 539 3400 Fax ( 713) 539 3411 Systems: absorption/ scrubber; combined SO2/ NOx control; ESP dry; ESP wet; FGD dry; FGDwet wet particulate scrubber Components/ supplies: absorber towers; pressure vessels Services: design; engineering; erection; maintenance and repair FORNEY CORPORATION 534 East Ortega Street Santa Barbara, CA 93103 ( 805) 963 6583 Fax ( 805) 962 4627 Systems: continuous emissions monitoring systems ( CEMS)

FUEL TECH 512 Kingsland Drive Batavia, IL 60510 2299 ( 630) 845 4500 Fax ( 630) 845 4501 Systems: NOx OUT; SNCR/ SCR hybrids; combined SO2/ NOx control; thermal oxidation, gas reburn Services: NOx control modeling GE ENERGY SERVICES 2849 Sterling Drive Hatfield, PA 19440 ( 215) 996 9200 Fax ( 215) 996 9201 Systems: CEMS, COMS, and related monitoring equipment and services.

HALDOR TOPSOE 17629 El Camino Real Suite 300 Houston, TX 77058 ( 281) 228 5000 Fax ( 281) 228 5109 PRODUCTS & SERVICES: Catalysts HAMON RESEARCH COTTRELL, INC. P. O. Box 1500 Somerville, NJ 08876 ( 908) 685 4000 Fax ( 908) 685 4050 Systems: Dry and wet ESPs; baghouses ( reverse gas, low/ medium/ high pressure pulse jets and COHPAC designs); NOx controls; U2A( tm) systems; acid gas abatement; ash handling; gas conditioning; air toxic controls, dust collection, gas to gas heat exchangers; and aftermarket services.

HITACHI ZOSEN CORPORATION 10777 Westheimer Road, Suite 1075 Houston, TX 77042 ( 713) 532 9611 Fax ( 713) 532 9533 PRODUCTS & SERVICES: SCR catalysts HORIBA INSTRUMENTS, INC. 17671 Armstrong Avenue Irvine, CA 92714 ( 714) 250 4811 Fax ( 714) 250 0924 Systems: continuous emissions monitoring systems JOHNSON MATTHEY CATALYTIC SYSTEMS DIVISION 456 Devon Park Drive Wayne, PA 19087 ( 610) 341 8300 Fax ( 610) 341 8258 Systems: SCR systems for engine industries and regenerative oxidation catalyst systems for process industries.

Components/ supplies: SCR catalyst, catalyst housing, catalyst elements, pelleted catalyst for printing, chlorinated catalyst KWH Germany: Paul Baumann Strasse, 1 Marl, Germany D 45764 [ 49] ( 2365) 49 2962 Fax [ 49] ( 2365) 49 4989 U. S.: 48364 State Route 14 New Waterford, OH 44445 ( 330) 457 2599 Fax ( 330) 457 2588 PRODUCTS & SERVICES: SCR honeycomb catalysts ( ZERONOx), honeycomb catalysts for destroying dioxins and furans ( ZERONOx D), and catalysts for oxidizing CO and VOC in cogeneration plants ( CATANOx)

LAND INSTRUMENTS INTERNATIONAL, LTD. 10 Friends Lane Newtown, PA 18940 ( 215) 504 8000 Fax ( 215) 504 0879 Systems: CEMS and related monitoring equipment and services.

MARSULEX ENVIRONMENTAL TECHNOLOGIES 200 North Seventh Street Lebanon, PA 17046 5006 ( 717) 274 7000 Fax ( 717) 274 7085 Systems: Wet and dry FGD; particulate, NOx, and ash technologies.

McGILL AIR CLEAN CORPORATION 1779 Refugee Road Columbus, OH 43207 ( 614) 443 0192 Fax ( 614) 445 8759 Systems: ESP dry; ESP wet; fabric filter; FGD dry; odor control; thermal oxidation MEGTEC SYSTEMS 830 Prosper St. P. O. Box 30 DePere, WI 54115 0030 ( 920) 336 5715 Fax ( 920) 339 2084 Systems: designs, manufactures, and services oxidation systems for the destruction of VOCs produced from a wide variety of industrial sources. Provides a full line of equipment including catalytic and thermal recuperative systems, direct thermal and catalytic oxidizers, and thermal regenerative systems. Standard models accomodate air flows from 2,000 SCFM to over 100,000 SCFM. Custom designs are also available.

MITSUBISHI POWER SYSTEMS, INC. 100 Bayview Circle, Suite 4000 Newport Beach, CA 92660 ( 949) 856 8400 Fax ( 949) 856 4481/ 4482 Systems: SCR MOBOTEC USA, INC. 3468 Mount Diablo Blvd. Suite B100 Lafayette, CA 94549 ( 925) 962 9040 Fax ( 925) 962 9044 Systems: MobotecSystemTM for NOx and/ or SOx reduction.

MPM TECHNOLOGIES AIRPOL 339 Jefferson Road Parsippany, NJ 07054 ( 973) 599 4400 Fax ( 973) 428 6048 Systems: acid gas absorption, particulate control, liquid mist control Components/ supplies: absorbers ( spray towers, tray towers, packed bed); venturi, cyclonic, dry, and semi dry scrubbers; wet ESPs; quenchers Services: installation, training, repair and upgrade HUNTINGTON ENVIRONMENTAL SYSTEMS 1501 East Woodfield Rd., Suite 200 West Schaumburg, IL 60173 ( 847) 706 6950 Fax ( 847) 706 6954 Systems: Regenerative Thermal Oxidation, Regenerative Catalytic Econ Abator ® , Thermal and Recuperative Catalytic, and Econ NOxTM Selective Catalytic Reduction. AirPol supplies wet ESPs and counter current packed towers for process industries.

PARSONS ENERGY & CHEMICALS GROUP, INC. 2675 Morgantown Road Reading, PA 19607 ( 610) 855 2000 Fax ( 610) 855 2001 Systems: Develop emissions control strategies and perform engineering, design, layouts, equipment specifications, procurement, construction specifications and management, balance ofplant modifications, and start up services.

POWERSPAN CORPORATION P. O. Box 219 54 Old Bay Road New Durham, NH 03855 ( 603) 859 2500 Fax ( 603) 859 2501 Systems: Electro Catalytic Oxidation ( ECOTM), a technology for coal fired powerplants that removes emissions of SO2, NOx, Hg, and PM2.5 in a single system.

SARGENT & LUNDY 55 E. Monroe Street Chicago, IL 60603 ( 312) 269 2000 Fax ( 312) 269 3146 Services: Engineering SOLIOS ENVIRONNEMENT 625, President Kennedy Avenue Montreal, Quebec H3A 1K2 ( 514) 284 0341 Fax ( 514) 284 1326 Systems: absorption/ scrubber; carbon injection; combined SO2/ NOx control; ESP dry; fabric filter; FGD dry; FGD wet; mechanical collector; wet particulate scrubber SPECTRUM SYSTEMS, INC. 3410 West Nine Mile Road Pensacola, FL 32526 ( 850) 944 3392 Fax ( 850) 944 1011 Services: Continuous emissions monitoring services, including maintenance, data acquisition and reporting, testing, parts, studies, training, and system manufacturing. THERMO ENVIRONMENTAL INSTRUMENTS INC. 8 West Forge Parkway Franklin, MA 02038 ( 508) 520 0430 Fax ( 508) 520 1460 VIG INDUSTRIES, INC. 4051 E. La Palma Ave., # C Anaheim, CA 92807 ( 714) 632 8200 Fax ( 714) 632 8201 Systems: hydrocarbon analyzers WHEELABRATOR AIR POLLUTION CONTROL, INC. 441 Smithfield Street Pittsburgh, PA 15222 ( 412) 562 7300 Fax ( 412) 562 7254 Systems: ESP dry; ESP wet; fabric filter; FGD dry; FGD wet; flue gas conditioning; mechanical collector; SCR; SNCR Components/ supplies: chimneys; ductwork; filter cartridges; microprocessor controls; mist eliminators; rapping systems Services: consulting; design; engineering; erection; maintenance and repair; rebuilds Back to ICAC's Home Page Back to Member directory