[Federal Register Volume 76, Number 192 (Tuesday, October 4, 2011)]
[Notices]
[Pages 61411-61413]
[FR Doc No: 2011-25475]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-65418; File No. SR-NYSEArca-2011-66]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change Amending Commentary
.04 to Rule 6.4 in Order To Simplify the $1 Strike Price Program

September 28, 2011.
    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 September 26, 2011, NYSE Arca, Inc. (the ``Exchange'' or
``NYSE Arca'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I and II
below, which Items have been prepared by the Exchange. The Commission
is publishing this notice to solicit comments on the proposed rule
change from interested persons.
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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 Commentary .04 to Rule 6.4 in order
to simplify the $1 Strike Price Program. The text of the proposed rule
change is available on the Exchange's Web site at http://www.nyse.com,
at the Exchange's principal office, on the Commission's Web site at
http://www.sec.gov, 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 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 those 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 is proposing to amend Commentary .04 to Rule 6.4 in
order to simplify the $1 Strike Price Program (``Program'').
    In 2003, the Commission issued an order permitting the Exchange to
establish the Program on a pilot basis.\3\ At that time, the underlying
stock had to close at or below $20 on the previous trading day in order
to qualify for the Program. The range of available $1 strike price
intervals was limited to a range between $3 and $20 and no strike price
was permitted that was greater than $5 from the underlying stock's
closing price on the previous trading day. Series in $1 strike price
intervals were not permitted within $0.50 of an existing strike. In
addition, the Exchange was limited to selecting five (5) classes and
reciprocal listing was permitted. Furthermore, Long-Term Equity Option
Series (``LEAPS'') in $1 strike price intervals were not permitted for
classes selected to participate in the Program.
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    \3\ See Securities Exchange Act Release No. 48045 (June 17,
2003), 68 FR 37594 (June 24, 2003) (SR-PCX-2003-28).
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    The Exchange renewed the pilot program on a yearly basis and, in
2008, the Exchange adopted the pilot program on a permanent basis.\4\
At that time, the Program was expanded to increase the upper limit of
the permissible strike price range from $20 to $50. In addition, the
number of class selections per exchange was increased from five (5) to
ten (10).
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    \4\ See Securities Exchange Act Release No. 57130 (January 10,
2008), 73 FR 3302 (January 17, 2008) (SR-NYSEArca-2008-04).
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    Since the Program was made permanent, the number of class
selections per exchange has been increased from ten (10) classes to 55
classes \5\ and subsequently increased from 55 classes to 150
classes.\6\
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    \5\ See Securities Exchange Act Release No. 59587 (March 17,
2009), 74 FR 12414 (March 24, 2009) (SR-NYSEArca-2009-10).
    \6\ See Securities Exchange Act Release No. 62450 (July 2,
2010), 75 FR 39712 (July 12, 2010) (SR-NYSEArca-2010-66).
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    The most recent expansion of the Program was approved by the
Commission in early 2011 and increased the number of $1 strike price
intervals permitted within the $1 to $50 range.\7\
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    \7\ See Securities Exchange Act Release No. 63770 (January 25,
2011), 76 FR 5627 (February 1, 2011) (SR-NYSEArca-2010-106).
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Amendments To Simplify Non-LEAPS Rule Text
    These numerous expansions have resulted in very lengthy rule text
that the Exchange believes is complicated and difficult to understand.
The Exchange believes that the proposed changes to simplify the rule
text of the Program would benefit market

participants since the Program will be easier to understand and would
maintain the expansions made to the Program, including those in early
2011. Through the current proposal, the Exchange also hopes to make
administration of the Program easier, e.g., system programming efforts.
To simplify the rules of the Program and, as a proactive attempt to
mitigate any unintentional listing of improper strikes, the Exchange is
proposing the following streamlining amendments:
     When the price of the underlying stock is equal to or less
than $20, permit $1 strike price intervals with an exercise price up to
100% above and 100% below the price of the underlying stock.\8\
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    \8\ See proposed new paragraph (b)(i) to Commentary .04 to Rule
6.4.
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    [cir] However, the above restriction would not prohibit the listing
of at least five (5) strike prices above and below the price of the
underlying stock per expiration month in an option class.\9\
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    \9\ Id.
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    [cir] For example, if the price of the underlying stock is $2, the
Exchange would be permitted to list the following series: $1, $2, $3,
$4, $5, $6 and $7.\10\
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    \10\ Id.
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     When the price of the underlying stock is greater than
$20, permit $1 strike price intervals with an exercise price up to 50%
above and 50% below the price of the underlying security up to $50.\11\
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    \11\ See proposed new paragraph (b)(ii) to Commentary .04 to
Rule 6.4.
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     For the purpose of adding strikes under the Program, the
``price of the underlying stock'' shall be measured in the same way as
``the price of the underlying security'' is, as set forth in Rule
6.4A(b)(1).\12\
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    \12\ See proposed new paragraph (b)(iii) to Commentary .04 to
Rule 6.4. Rule 6.4A(b)(1) provides, ``[t]he price of the underlying
security is measured by: (1) For intra-day add-on series and next-
day series additions, the daily high and low of all prices reported
by all national securities exchanges; (2) for new expiration months,
the daily high and low of all prices reported by all national
securities exchanges on the day the Exchange determines its
preliminary notification of new series; and (3) for options series
to be added as a result of pre-market trading, the most recent share
price reported by all national securities exchanges between 8:45
a.m. and 9:30 a.m. Eastern Time.''
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     Prohibit the listing of additional series in $1 strike
price intervals if the underlying stock closes at or above $50 in its
primary market and provide that additional series in $1 strike price
intervals may not be added until the underlying stock closes again
below $50.\13\
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    \13\ See proposed new paragraph (b)(iv) to Commentary .04 to
Rule 6.4. The Exchange believes that it is important to codify this
additional series criterion because there have been conflicting
interpretations among the exchanges that have adopted similar
programs. The $50 price criterion for additional series was intended
when the Program was originally established (as a pilot) in 2003.
See supra note 4 (``the Exchange may list an additional expiration
month for a $1 strike series provided that the underlying strike
price closes b[e]low $20 on its primary market on expiration Friday.
If the underlying closes at or above $20 on expiration Friday, the
Exchange would not list an additional month for $1 strike series
until the stock again closes below $20.'').
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Amendments To Simplify LEAPS Rule Text
    The early 2011 expansion of the Program permitted for some limited
listing of LEAPS in $1 strike price intervals for classes that
participate in the Program. The Exchange is proposing to maintain the
expansion as to LEAPS, but simplify the language and provide examples
of the simplified rule text. These changes are set forth in proposed
new paragraph (b)(v) to Commentary .04 to Rule 6.4.
    For stocks in the Program, the Exchange may list one $1 strike
price interval between each standard $5 strike price interval, with the
$1 strike price interval being $2 above the standard strike for each
interval above the price of the underlying stock, and $2 below the
standard strike for each interval below the price of the underlying
stock (``$2 wings''). For example, if the price of the underlying stock
is $24.50, the Exchange may list the following standard strikes in $5
intervals: $15, $20, $25, $30 and $35. Between these standard $5
strikes, the Exchange may list the following $2 wings: $18, $27 and
$32.\14\
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    \14\ The Exchange notes that a $2 wing is not permitted between
the standard $20 and $25 strikes in the above example. This is
because the $2 wings are added based on reference to the price of
the underlying and as being between the standard strikes above and
below the price of the underlying stock. Since the price of the
underlying stock ($24.50) straddles the standard strikes of $20 and
$25, no $2 wing is permitted between these standard strikes.
---------------------------------------------------------------------------

    In addition, the Exchange may list the $1 strike price interval
which is $2 above the standard strike just below the underlying price
at the time of listing. In the above example, since the standard strike
just below the underlying price ($24.50) is $20, the Exchange may list
a $22 strike. The Exchange may add additional LEAP strikes as the price
of the underlying stock moves, consistent with the Options Listing
Procedures Plan (``OLPP'').
Non-Substantive Amendments to Rule Text
    The early 2011 expansion of the Program prohibited the listing of
$2.50 strike price intervals for classes that participate in the
Program. This prohibition applies to non-LEAPS and LEAPS. The Exchange
proposes to maintain this prohibition and codify it in paragraph (a) to
Commentary .04 to Rule 6.4 (Program Description).
    For ease of reference, the Exchange is proposing to add the
headings ``Program Description,'' ``Initial and Additional Series'' and
``LEAPS'' to Commentary .04 to Rule 6.4.
    The Exchange is proposing to more accurately reflect the nature of
the Program and is proposing to make stylistic changes throughout
Commentary .04 to Rule 6.4 by renaming the Program ``The $1 Strike
Price Interval Program'' and by adding the phrase ``price interval.''
    The Exchange proposes to reorganize certain text of Commentary .04
to Rule 6.4 and portions of the Delisting Policy therein in order to
better organize Commentary .04. This would include moving current
paragraph (b) out of Commentary .04 and instead including the text as
new Commentary .13 to Rule 6.4.
    Lastly, the Exchange is making technical changes to Commentary .04
to Rule 6.4, e.g., replacing the word ``security'' with the word
``stock.''
    The Exchange represents that it has the necessary systems capacity
to support the increase in new options series that would result from
the proposed streamlining changes to the Program.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Act,\15\ in general, and furthers the
objectives of Section 6(b)(5) of the Act,\16\ in particular, because it
is designed to promote just and equitable principles of trade, remove
impediments to and perfect the mechanisms of a free and open market and
a national market system and, in general, to protect investors and the
public interest. In particular, the proposed rule change seeks to
reduce investor confusion and to simplify the provisions of the $1
Strike Price Interval Program.
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    \15\ 15 U.S.C. 78f(b).
    \16\ 15 U.S.C. 78f(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Act,\17\ in general, and furthers the
objectives of Section 6(b)(5) of the Act,\18\ in particular, because it
is designed to promote just and equitable

principles of trade, remove impediments to and perfect the mechanisms
of a free and open market and a national market system and, in general,
to protect investors and the public interest. In particular, the
proposed rule change seeks to reduce investor confusion and to simplify
the provisions of the $1 Strike Price Interval Program.
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    \17\ 15 U.S.C. 78f(b).
    \18\ 15 U.S.C. 78f(b)(5).
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C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    No written comments were solicited or received with respect to the
proposed rule change.

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

    Because the foregoing proposed rule change does not significantly
affect the protection of investors or the public interest, does not
impose any significant burden on competition, and, by its terms, does
not become operative for 30 days from the date on which it was filed,
or such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A) of the Act \19\ and Rule 19b-
4(f)(6) thereunder.\20\
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    \19\ 15 U.S.C. 78s(b)(3)(A).
    \20\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires the Exchange to give the Commission written notice of the
Exchange's intent to file the proposed rule change, along with a
brief description and text of the proposed rule change, at least
five business days prior to the date of filing of the proposed rule
change, or such shorter time as designated by the Commission. The
Exchange has satisfied the five-day prefiling requirement.
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    The Exchange has requested that the Commission waive the 30-day
operative delay. The Commission believes that waiver of the operative
delay is consistent with the protection of investors and the public
interest because the proposal is substantially similar to that of
another exchange that has been approved by the Commission.\21\
Therefore, the Commission designates the proposal operative upon
filing.\22\
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    \21\ See Securities Exchange Act Release No. 65383 (September
22, 2011) (SR-CBOE-2011-040) (order approving proposed rule change
to simplify the $1 Strike Price Interval Program).
    \22\ For purposes only of waiving the 30-day operative delay,
the Commission has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
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    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule should be approved or disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-NYSEArca-2011-66 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-NYSEArca-2011-66. This
file number should be included on the subject line if e-mail is used.
To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments,
all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for website
viewing and printing in the Commission's Public Reference Room, 100 F
Street, NE., Washington, DC 20549, on official business days between
the hours of 10 a.m. and 3 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
publicly available. All submissions should refer to File Number SR-
NYSEArca-2011-66 and should be submitted on or before October 25, 2011.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\23\
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    \23\ 17 CFR 200.30-3(a)(12).
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Elizabeth M. Murphy,
Secretary.
[FR Doc. 2011-25475 Filed 10-3-11; 8:45 am]
BILLING CODE 8011-01-P


Call with Michigan: Pharmaceuticals and UWR

Call participants:

	Meg McCarthy

	Patricia Mercer

	Lisa Lauer

	Jack Sinderle – MI DEQ

Call date:  October 30, 2006

Purpose:  To ascertain any problems/issues with MI’s inclusion of
hazardous pharmaceutical wastes as universal wastes.  MI added
pharmaceuticals to their UW rule in December 2004.

Notes:  Rule seems to be working very well.  When proposing the rule, MI
received a number of positive comments, indicating that the proposed
rule was well-liked.  MI has not heard from health care facilities
(HCFs) that the rule is too burdensome.  When rule was being proposed,
HCFs were in the process of becoming compliant RCRA, so the UWR came
around just at the right time for them.


[Federal Register Volume 81, Number 19 (Friday, January 29, 2016)]
[Notices]
[Pages 5013-5014]
[FR Doc No: 2016-01706]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

[ER-FRL-9025-3]

Environmental Impact Statements; Notice of Availability

    Responsible Agency: Office of Federal Activities, General
Information<PHONE_NUMBER> or http://www2.epa.gov/nepa.
    Weekly receipt of Environmental Impact Statements (EISs), Filed 01/
18/2016 Through 01/22/2016, Pursuant to 40 CFR 1506.9.

Notice

    Section 309(a) of the Clean Air Act requires that EPA make public
its comments on EISs issued by other Federal agencies. EPA's comment
letters on EISs are available at: https://cdxnodengn.epa.gov/cdx-nepa-public/action/eis/search.

EIS No. 20160016, Final, FHWA, TX, SH 249 Extension, Contact: Carlos
Swonke<PHONE_NUMBER>, Under MAP-21 Section 1319 FHWA has issued a single
FEIS and ROD. Therefore, the 30-day wait/review period under NEPA does
not apply to this action.
EIS No. 20160017, Draft, USFS, AK, Shoreline II Oufitter/Guide
(formerly

Shoreline II, Outfitter and Guide Management Plan), Comment Period
Ends:, 03/14/2016, Contact: Carey Case<PHONE_NUMBER>.
EIS No. 20160018, Draft, NPS, MD, Assateague Island National Seashore
General Management Plan, Comment Period Ends: 05/01/2016, Contact:
Deborah Darden<PHONE_NUMBER>.
EIS No. 20160019, Final, USFS, OR, Kahler Dry Forest Restoration,
Review Period Ends: 03/14/2016, Contact: John Evans<PHONE_NUMBER>.
EIS No. 20160020, Draft, USFS, CA, Lassen National Forest Over-Snow
Vehicle (OSV) Use Designation, Comment Period Ends: 03/15/2016,
Contact: Chris Obrien<PHONE_NUMBER>.
EIS No. 20160021, Draft, USACE, NY, Mamaroneck and Sheldrake Rivers
Flood Risk Management Village of Mamaroneck General Reevaluation,
Comment Period Ends: 03/14/2016, Contact: Matthew Voisine<PHONE_NUMBER>.

Amended Notices

EIS No. 20150312, Draft, FRA, NY, NEC FUTURE Tier 1, Comment Period
Ends: 02/16/2016, Contact: Rebecca Reyes-Alicea<PHONE_NUMBER>, Revision
to FR Notice Published 11/13/2015; Extending Comment Period from 01/30/
2016 to 02/16/2016.
EIS No. 20150353, Draft, FRA, MD, Baltimore and Potomac Tunnel Project,
Comment Period Ends: 02/19/2016, Contact: Michelle W. Fishburne 202-
293-0398, Revision to FR Notice Published 12/18/20105; Extending
Comment Period from 02/05/2016 to 02/19/2016.
EIS No. 20150358, Draft, USACE, FL, Herbert Hoover Dike Dam Safety
Modification, Comment Period Ends: 02/23/2016, Contact: Stacie
Auvenshine<PHONE_NUMBER>, Revision to FR Notice Published 12/24/2015;
Correction to Comment Period from 02/08/2016 to 02/23/2016.
EIS No. 20160001, Final, FHWA, CO, I-70 East, Review Period Ends: 03/
02/2016, Contact: Chris Horn<PHONE_NUMBER>, Revision to FR Notice
Published 01/15/2016; Extending Comment Period from 02/16/2016 to 03/
02/2016.
EIS No. 20160008, Draft, USFS, WY, Withdrawn--Bear Lodge Project,
Contact: Jeanette Timm<PHONE_NUMBER>, Revision to FR Notice Published
01/15/2016; The U.S. Department of Agriculture's Forest Service has
Officially Withdrawn this EIS.

    Dated: January 26, 2016.
Dawn Roberts,
Management Analyst, NEPA Compliance Division, Office of Federal
Activities.
[FR Doc. 2016-01706 Filed 1-28-16; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register: May 24, 2006 (Volume 71, Number 100)]
[Notices]
[Page 29954]
[DOCID:fr24my06-86]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2006-0465; FRL-8069-9]

The Association of American Pesticide Control Officials (AAPCO)/
State-FIFRA Issues Research and Evaluation Group (SFIREG); Notice of
Public Meeting

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY:  The Association of American Pesticide Control Officials
(AAPCO)/State-FIFRA Issues Research and Evaluation Group (SFIREG) will
hold a 2-day meeting, beginning on June 19, 2006 and ending June 20,
2006. This notice announces the location and times for the meeting and
sets forth the tentative agenda topics.

DATES: The meeting will be held on June 19 from 9 a.m. to 5 p.m. and
June 20, 2006 from 9 a.m. to 12 noon.

FOR FURTHER INFORMATION CONTACT: Georgia McDuffie, Field and External
Affairs Division (7506P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>; e-
mail address<EMAIL_ADDRESS>or Philip H. Gray, SFIREG
Executive Secretary, P.O. Box 1249, Hardwick, VT 05843-1249; telephone
number<PHONE_NUMBER>; fax:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you all parties
interested in SFIREG information exchange relationship with EPA
regarding important issues related to human health, environmental
exposure to pesticides and insight into EPA's decision-making process
are invited and encourage to attend the meetings and participate as
appropriate Potentially affected entities may include, but are not
limited to:
    This action is directed to the public in general, and may be of
particular interest to those persons who are or may be required to
conduct testing of chemical substances under the Federal Food Drug and
Cosmetic Act (FFDCA), or the Federal Insecticide, Fungicide, and
Rondenticide Act (FIFRA).

B. How Can I Get Copies of this Document and Other Related Information?

    1. Docket. EPA has established a docket for this action under
docket identification (ID) number EPA-HQ-OPPT-2006-0465. Publicly
available docket materials are available either in the electronic
docket at http://www.regulations.gov, or, if only available in hard

copy, at the Office of Pesticide Programs (OPP) Regulatory Public
Docket in Rm. S-4400, One Potomac Yard (South Building), 2777 S.
Crystal Drive Arlington, VA. The hours of operation of this Docket
Facility are from 8:30 a.m. to 4 p.m., Monday through Friday, excluding
legal holidays. The Docket telephone number is<PHONE_NUMBER>.
    2. Electronic access. You may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr.

C. Tentative Agenda

1. Container Recycling Rule Making Discussion
2. WPS proposed Changes
3. Unique Label Identifiers - RAPID
4. Endangered Species Enforcement Concerns
5. NPDES - Pesticides in Water Discussion on Rule
6. Availability of Laboratory Methods to States
7. Budget, General Discussion and C & T Funding
8. EPA Update/Briefing:
    a. Office of Pesticide Program Update
    b. Office of Enforcement Compliance Assurance Update

List of Subjects

    Environmental protection.

    Dated: May 16, 2006.
William R. Diamond,
Director, Field External Affairs Division, Office of Pesticide Programs
[FR Doc. E6-7931 Filed 5-23-06; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 86, Number 10 (Friday, January 15, 2021)]
[Notices]
[Pages 4081-4083]
[FR Doc No: 2021-00833]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-2306]

TG United Inc., et al.; Withdrawal of Approval of 27 Abbreviated
New Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is
withdrawing approval of 27 abbreviated new drug applications (ANDAs)
from multiple applicants. The applicants notified the Agency in writing
that the drug products were no longer marketed and requested that the
approval of the applications be withdrawn.

DATES: Approval is withdrawn as of February 16, 2021.

FOR FURTHER INFORMATION CONTACT: Martha Nguyen, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1676, Silver Spring, MD 20993-0002, 240-
402-6980<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The applicants listed in the table have
informed FDA that these drug products are no longer marketed and have
requested that FDA withdraw approval of the applications under the
process described in Sec.  314.150(c) (21 CFR 314.150(c)). The
applicants have also, by their requests, waived their opportunity for a
hearing. Withdrawal of approval of an application or abbreviated
application under Sec.  314.150(c) is without prejudice to refiling.

------------------------------------------------------------------------
        Application No.                  Drug               Applicant
------------------------------------------------------------------------
ANDA 040083...................  Phentermine             TG United Inc.,
                                 Hydrochloride (HCl)     16275 Aviation
                                 Capsules, 30            Loop Dr.,
                                 milligrams (mg).        Brooksville, FL
                                                         34604.
ANDA 040451...................  Cyanocobalamin          Mylan
                                 Injection, 1 mg/        Institutional
                                 milliliters (mL).       LLC, 4901
                                                         Hiawatha Dr.,
                                                         Rockford, IL
                                                         61103.
ANDA 040518...................  Bethanechol Chloride    Morton Grove
                                 Tablets, 50 mg.         Pharmaceuticals
                                                         Inc./Wockhardt
                                                         USA LLC, 6451
                                                         W. Main St.,
                                                         Morton Grove,
                                                         IL 60053.
ANDA 040532...................  Bethanechol Chloride    Do.
                                 Tablets, 5 mg.

ANDA 060347...................  Tetracycline HCl        Pharmacia &
                                 Capsules, 250 mg.       Upjohn Co., a
                                                         subsidiary of
                                                         Pfizer Inc.,
                                                         235 East 42nd
                                                         St., New York,
                                                         NY 10017.
ANDA 060478...................  Neomycin Sulfate        Pfizer Inc., 235
                                 Ophthalmic Ointment.    East 42nd St.,
                                                         New York, NY
                                                         10017.
ANDA 065266...................  Clarithromycin          Morton Grove
                                 Tablets, 250 mg and     Pharmaceuticals
                                 500 mg.                 Inc./Wockhardt
                                                         USA LLC.
ANDA 065281...................  Doxycycline Hyclate     Bausch Health
                                 Delayed Release         US, LLC, 400
                                 Capsules, Equivalent    Somerset
                                 to (EQ) 75 mg base;     Corporate
                                 EQ 100 mg base.         Blvd.,
                                                         Bridgewater, NJ
                                                         08807.
ANDA 075208...................  Ranitidine HCl          Morton Grove
                                 Tablets, EQ 150 mg      Pharmaceuticals
                                 base; EQ 300 mg base.   Inc./Wockhardt
                                                         USA LLC.
ANDA 075822...................  Loratadine Orally       GlaxoSmithKline
                                 Disintegrating          Consumer
                                 Tablets, 10 mg.         Healthcare
                                                         Holdings (US)
                                                         LLC, 184
                                                         Liberty Corner
                                                         Rd., Suite 200,
                                                         Warren, NJ
                                                         07059.
ANDA 076760...................  Ranitidine HCl          Morton Grove
                                 Tablets, EQ 75 mg       Pharmaceuticals
                                 base.                   Inc./Wockhardt
                                                         USA LLC.
ANDA 076849...................  Vinorelbine Tartrate    Fresenius Kabi
                                 Injection, EQ 10 mg     USA, LLC, Three
                                 base/mL.                Corporate Dr.,
                                                         Lake Zurich, IL
                                                         60047.
ANDA 077432...................  Carboplatin Injection,  Do.
                                 50 mg/5 mL(10 mg/mL),
                                 150 mg/15 mL (10 mg/
                                 mL), and 450 mg/45 mL
                                 (10 mg/mL).
ANDA 078500...................  Amlodipine Besylate     Morton Grove
                                 Tablets, EQ 2.5 mg      Pharmaceuticals
                                 base; EQ 5 mg base;     Inc./Wockhardt
                                 EQ 10 mg base.          USA LLC.
ANDA 084041...................  Chlordiazepoxide HCl    Upsher-Smith
                                 Capsules, 10 mg.        Laboratories,
                                                         LLC, 6701
                                                         Evenstad Dr.,
                                                         Maple Grove, MN
                                                         55369.
ANDA 084678...................  Chlordiazepoxide HCl    Do.
                                 Capsules, 5 mg.
ANDA 084679...................  Chlordiazepoxide HCl    Do.
                                 Capsules, 25 mg.
ANDA 088508...................  Homatropine             King
                                 Methylbromide;          Pharmaceuticals
                                 Hydrocodone             Research and
                                 Bitartrate Tablets,     Development,
                                 1.5 mg; 5 mg.           LLC, 4000
                                                         Centregreen
                                                         Way, Suite 300,
                                                         Cary, NC 27513.
ANDA 089953...................  Thioridazine HCl        Sun
                                 Tablets, 10 mg, 25      Pharmaceutical
                                 mg, 50 mg, and 100 mg.  Industries,
                                                         Inc., 2
                                                         Independence
                                                         Way, Princeton,
                                                         NJ 08540.
ANDA 090094...................  Didanosine Delayed      Aurobindo Pharma
                                 Release Capsules, 125   USA, Inc., 279
                                 mg, 200 mg, 250 mg,     Princeton-
                                 and 400 mg.             Hightstown Rd.,
                                                         East Windsor,
                                                         NJ 08520.
ANDA 090394...................  Iopamidol Injection,    Sanochemia
                                 61% and 76%.            Corporation
                                                         USA, 9201
                                                         University City
                                                         Blvd., c/o
                                                         Countervail
                                                         Corp.,
                                                         Charlotte, NC
                                                         08876.
ANDA 091302...................  Fludrocortisone         Hikma
                                 Acetate Tablets, 0.1    Pharmaceuticals
                                 mg.                     USA Inc., 1809
                                                         Wilson Rd.,
                                                         Columbus, OH
                                                         43228.
ANDA 203959...................  Temozolomide Capsules,  Watson
                                 5 mg, 20 mg, 100 mg,    Laboratories,
                                 140 mg, and 250 mg.     Inc. (an
                                                         indirect,
                                                         wholly owned
                                                         subsidiary of
                                                         Teva
                                                         Pharmaceuticals
                                                         USA, Inc.), 425
                                                         Privet Rd.,
                                                         Horsham, PA
                                                         19044.
ANDA 204243...................  Indomethacin Extended   Aurobindo Pharma
                                 Release Capsules, 75    USA, Inc.
                                 mg.
ANDA 206061...................  Pravastatin Sodium      Hisun
                                 Tablets, 20 mg, 40      Pharmaceuticals
                                 mg, and 80 mg.          USA, Inc., 200
                                                         Crossing Blvd.,
                                                         2nd Floor,
                                                         Bridgewater, NJ
                                                         08807.
ANDA 206857...................  Tiagabine HCl Tablets,  Wilshire
                                 2 mg, 4 mg, 12 mg,      Pharmaceuticals
                                 and 16 mg.              , Inc., 6
                                                         Concourse
                                                         Pkwy., Suite
                                                         1800, Atlanta,
                                                         GA 30328.
ANDA 209076...................  Ibuprofen Tablets, 200  Ultra Tab
                                 mg.                     Laboratories,
                                                         Inc., 50 Toc
                                                         Dr., Highland,
                                                         NY 12528.
------------------------------------------------------------------------

    Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of
February 16, 2021. Approval of each entire application is withdrawn,
including any strengths and dosage forms inadvertently missing from the
table. Introduction or delivery for introduction into interstate
commerce of products without approved new drug applications violates
section 301(a) and (d) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 331(a) and (d)). Drug products that are listed in the table that
are in inventory on February 16, 2021 may continue to be dispensed
until the inventories have been depleted or the drug products have
reached their expiration dates or otherwise become violative, whichever
occurs first.

    Dated: January 11, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-00833 Filed 1-14-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: June 9, 2010 (Volume 75, Number 110)]
[Notices]
[Page 32824]
[DOCID:fr09jn10-114]

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

SECURITIES AND EXCHANGE COMMISSION

Submission for OMB Review; Comment Request

    Upon Written Request, Copies Available From: Securities and
Exchange Commission, Office of Investor Education and Advocacy,
Washington, DC 20549-0213.
    Extension: Rule 10b-10; SEC File No. 270-389; OMB Control No. 3235-
0444.
    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) has submitted to the Office of Management and Budget a
request for approval of extension of the previously approved collection
of information provided for in Rule 10b-10 (17 CFR 240.10b-10) under
the Securities and Exchange Act of 1934 (15 U.S.C. 78a et seq.)
    Rule 10b-10 requires broker-dealers to convey basic trade
information to customers regarding their securities transactions. This
information includes: the date and time of the transaction, the
identity and number of shares bought or sold, and the trading capacity
of the broker-dealer. Depending on the trading capacity of the broker-
dealer, Rule 10b-10 requires the disclosure of commissions as well as
mark-up and mark-down information. For transactions in debt securities,
Rule 10b-10 requires the disclosure of redemption and yield
information. Rule 10b-10 potentially applies to all of the
approximately 5,178 firms registered with the Commission that effect
transactions on behalf of customers.
    Based on information provided by registered broker-dealers to the
Commission in FOCUS Reports, the Commission staff estimates that on
average, registered broker-dealers process approximately 1.4 billion
order tickets per month for transactions on behalf of customers. Each
order ticket representing a transaction effected on behalf of a
customer results in one confirmation. Therefore, the Commission staff
estimates that approximately 16.8 billion confirmations are sent to
customers annually. The confirmations required by Rule 10b-10 are
generally processed through automated systems. It takes approximately 1
minute to generate and send a confirmation. Accordingly, the Commission
estimates that broker-dealers spend 280 million hours per year
complying with Rule 10b-10.
    The amount of confirmations sent and the cost of sending each
confirmation varies from firm to firm. Smaller firms generally send
fewer confirmations than larger firms because they effect fewer
transactions. The Commission staff estimates the costs of producing and
sending a paper confirmation, including postage to be approximately 96
cents. The Commission staff also estimates that the cost of producing a
sending a wholly electronic confirmation is approximately 52 cents.
Based on informal discussions with industry participants as well as no-
action positions taken in this area, the staff estimates that broker-
dealers used electronic confirmations for approximately 25 percent of
transactions. Based on these calculations, Commission staff estimates
that 12,600,000,000 paper confirmations are mailed each year at a cost
of $12,096,000,000. Commission staff also estimates that 4,200,000,000
wholly electronic confirmations are sent each year at a cost of
$2,184,000,000. Accordingly, Commission staff estimates that total
annual cost associated with generating and delivering to investors the
information required under Rule 10b-10 would be $14,280,000,000.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid control number.
    Comments should be directed to: (i) Desk Officer for the Securities
and Exchange Commission, Office of Information and Regulatory Affairs,
Office of Management and Budget, Room 10102, New Executive Office
Building, Washington, DC 20503 or send an e-mail to: Shagufta_
<EMAIL_ADDRESS>and (ii) Charles Boucher Director/Chief Information
Officer, Securities and Exchange Commission, c/o Shirley Martinson,
6432 General Green Way, Alexandria VA 22312 or send an e-mail to: PRA_
<EMAIL_ADDRESS>Comments must be submitted to OMB within 30 days of
this notice.

    Dated: June 2, 2010.
Elizabeth M. Murphy,
Secretary.
[FR Doc. 2010-13834 Filed 6-8-10; 8:45 am]
BILLING CODE 8010-01-P