[Federal Register Volume 77, Number 21 (Wednesday, February 1, 2012)]
[Notices]
[Pages 5028-5029]
[FR Doc No: 2012-2109]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Withdrawal of Approval of New Animal Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of 20 new animal drug applications (NADAs) at the sponsor's request
because the products are no longer manufactured or marketed.

DATES: Withdrawal of approval is effective February 13, 2012.

FOR FURTHER INFORMATION CONTACT: John Bartkowiak, Center for Veterinary
Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl.,
Rockville, MD 20855,<PHONE_NUMBER>, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The following sponsors have requested that
FDA withdraw approval of the 20 NADAs listed in table 1 of this
document because the products are no longer manufactured or marketed:

                           Table 1--NADAs for Which Approval is Voluntarily Withdrawn
----------------------------------------------------------------------------------------------------------------
         Application No.                    Trade name  (drug)                           Applicant
----------------------------------------------------------------------------------------------------------------
NADA 014-485....................  METOPHANE Inhalation (methoxyflurane).  Medical Developments, International
                                                                           Ltd., 556 Morris Ave., Summit, NJ
                                                                           07901-1330.
NADA 032-322....................  LIQUISONE F with Cerumene               Evsco Pharmaceuticals, an Affiliate of
                                   (hexamethyltetracosane, prednisolone,   IGI, Inc., Box 209, Harding Hwy.,
                                   tetracaine, neomycin sulfate).          Buena, NJ 08310.
NADA 044-655....................  NEOMYCANE Ophthalmic Ointment           Evsco Pharmaceuticals, an Affiliate of
                                   (neomycin sulfate).                     IGI, Inc., Box 209, Harding Hwy.,
                                                                           Buena, NJ 08310.
NADA 045-288....................  OPTISONE (neomycin sulfate,             Evsco Pharmaceuticals, an Affiliate of
                                   prednisolone acetate).                  IGI, Inc., Box 209, Harding Hwy.,
                                                                           Buena, NJ 08310.
NADA 049-890....................  NORCO T-2 Pre-Pak (tylosin phosphate).  Norco Mills of Norfolk, Inc., P.O. Box
                                                                           56, Norfolk, NE 68701.
NADA 055-034....................  CHLORASOL (chloramphenicol)...........  Evsco Pharmaceuticals, an Affiliate of
                                                                           IGI, Inc., Box 209, Harding Hwy.,
                                                                           Buena, NJ 08310.
NADA 055-052....................  Chlora-Tabs 100 (chloramphenicol).....  Evsco Pharmaceuticals, an Affiliate of
                                                                           IGI, Inc., Box 209, Harding Hwy.,
                                                                           Buena, NJ 08310.
NADA 065-158....................  CHLORICOL (chloramphenicol)...........  Evsco Pharmaceuticals, An Affiliate of
                                                                           IGI, Inc., Box 209, Harding Hwy.,
                                                                           Buena, NJ 08310.
NADA 065-259....................  CHLORASONE Ophthalmic Ointment          Evsco Pharmaceuticals, an Affiliate of
                                   (chloramphenicol, prednisolone          IGI, Inc., Box 209, Harding Hwy.,
                                   acetate).                               Buena, NJ 08310.
NADA 065-488....................  BENZA-PEN (penicillin G benzathine,     Walco International, Inc., 15 West
                                   penicillin G procaine).                 Putnam, Porterville, CA 93257.

NADA 095-953....................  MOORMABOOST TY 4000 Medicated (tylosin  ADM Alliance Nutrition, Inc., 1000
                                   phosphate).                             North 30th St., Quincy, IL 62305-
                                                                           3115.
NADA 100-689....................  DIFIL Syrup (diethylcarbamazine         Evsco Pharmaceuticals, an Affiliate of
                                   citrate).                               IGI, Inc., Box 209, Harding Hwy.,
                                                                           Buena, NJ 08310.
NADA 100-690....................  DIFIL Tablets (diethylcarbamazine       Evsco Pharmaceuticals, an Affiliate of
                                   citrate).                               IGI, Inc., Box 209, Harding Hwy.,
                                                                           Buena, NJ 08310.
NADA 107-957....................  TYLAN 20 Sulfa-G (tylosin phosphate     ADM Alliance Nutrition, Inc., 1000
                                   and sulfamethazine).                    North 30th St., Quincy, IL 62305-
                                                                           3115.
NADA 111-069....................  TYLAN 40 Sulfa-G (tylosin phosphate     ADM Alliance Nutrition, Inc., 1000
                                   and sulfamethazine).                    North 30th St., Quincy, IL 62305-
                                                                           3115.
NADA 131-956....................  TYLAN Sulfa-G (tylosin phosphate and    ADM Alliance Nutrition, Inc., 1000
                                   sulfamethazine).                        North 30th St., Quincy, IL 62305-
                                                                           3115.
NADA 131-957....................  TYLAN 40 (tylosin phosphate)..........  ADM Alliance Nutrition, Inc., 1000
                                                                           North 30th St., Quincy, IL 62305-
                                                                           3115.
NADA 133-490....................  Ban-D-Wormer II BANMINTH (pyrantel      ADM Alliance Nutrition, Inc., 1000
                                   tartrate).                              North 30th St., Quincy, IL 62305-
                                                                           3115.
NADA 140-842....................  HYGROMIX 2.4 Premix (hygromycin B)....  ADM Alliance Nutrition, Inc., 1000
                                                                           North 30th St., Quincy, IL 62305-
                                                                           3115.
NADA 140-958....................  EQUIPHEN Paste (phenylbutazone).......  Luitpold Pharmaceuticals, Inc., Animal
                                                                           Health Division, Shirley, NY 11967.
----------------------------------------------------------------------------------------------------------------

    Therefore, under authority delegated to the Commissioner of Food
and Drugs and redelegated to the Center for Veterinary Medicine, and in
accordance with Sec.  514.116 Notice of withdrawal of approval of
application (21 CFR 514.116), notice is given that approval of NADAs
014-485, 032-322, 044-655, 045-288, 049-890, 055-034, 055-052, 065-158,
065-259, 065-488, 095-953, 100-689, 100-690, 107-957, 111-069, 131-956,
131-957, 133-490, 140-842, and 140-958, and all supplements and
amendments thereto, is hereby withdrawn, effective February 13, 2012.
    In a final rule published elsewhere in this issue of the Federal
Register, FDA is amending the animal drug regulations to reflect the
withdrawal of approval of these applications.

    Dated: January 26, 2012.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2012-2109 Filed 1-31-12; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register: October 4, 2007 (Volume 72, Number 192)]
[Notices]
[Page 56756-56757]
[DOCID:fr04oc07-52]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-8479-2; Docket ID No. EPA-HQ-ORD-2007-0971]

An Exploratory Study: Assessment of Modeled Dioxin Exposure in
Ceramic Art Studios

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of public comment period.

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SUMMARY: EPA is announcing a 45-day public comment period for the
external review draft document titled, ``An Exploratory Study:
Assessment of Modeled Dioxin Exposure in Ceramic Art Studios'' (EPA/
600/R-06/044A). The draft document was prepared by the National Center
for Environmental Assessment (NCEA) within EPA's Office of Research and
Development.
    For the external scientific peer review, EPA has contracted with
Eastern Research Group (ERG) to convene an independent panel of experts
and organize and conduct an external peer-review workshop. The date and
location for the external peer-review workshop will be announced in a
separate Federal Register notice. The public comment period and the
external peer-review workshop are separate processes that provide
opportunities for all interested parties to comment on the document. In
addition to consideration by EPA, all public comments submitted in
accordance with this notice will also be forwarded to EPA's contractor
for the external peer-review panel's consideration prior to the
workshop.
    EPA is releasing this external review draft document solely for the
purpose of pre-dissemination peer review under applicable information
quality guidelines. This document has not been formally disseminated by
EPA. It does not represent and should not be construed to represent any
Agency policy or determination.

DATES: The 45-day public comment period begins October 4, 2007, and
ends November 19, 2007. Technical comments should be in writing and
must be received by EPA by November 19, 2007.

ADDRESSES: The external review draft document, ``An Exploratory Study:
Assessment of Modeled Dioxin Exposure in Ceramic Art Studios,'' is
available primarily via the Internet on the National Center for
Environmental Assessment's home page under the Recent Additions and the
Data and Publications menus at http://www.epa.gov/ncea. A limited

number of paper copies are available from the Technical Information
Staff, NCEA-W; telephone:<PHONE_NUMBER>; facsimile:<PHONE_NUMBER>. If you
are requesting a paper copy of the draft document, please provide your
name, mailing address, and the document title, ``An Exploratory Study:
Assessment of Modeled Dioxin Exposure in Ceramic Art Studios.''
    Comments may be submitted electronically via http://www.regulations.gov
, by mail, by facsimile, or by hand delivery/

courier. Please follow the detailed instructions as provided in the
SUPPLEMENTARY INFORMATION section of this notice.

FOR FURTHER INFORMATION CONTACT: For information on the public comment
period, contact the Office of Environmental Information Docket;
telephone:<PHONE_NUMBER>; facsimile:<PHONE_NUMBER>; or e-mail:
<EMAIL_ADDRESS>
    If you need technical information about the draft document, please
contact John Schaum, National Center for Environmental Assessment
(NCEA); telephone:<PHONE_NUMBER>; facsimile:<PHONE_NUMBER>; e-mail
<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION:

I. Information About the Document

    The purpose of this report is to describe an exploratory
investigation of potential dioxin exposures to artists and hobbyists
who use ball clay to make pottery and related products. Dermal,
inhalation and ingestion exposures to clay were measured at the
ceramics art department of Ohio State University in Columbus, Ohio.
Estimates of exposure were made based on measured levels of clay in the
studio air, deposited on surrogate food samples and on the skin of
artists. The measurements were made in two separate studies, one in
April 2003 and one in July 2004. This draft assessment combines the
results of these two studies.

II. How To Submit Technical Comments to the Docket at
http://www.regulations.gov

    Submit your comments, identified by Docket ID No. EPA-HQ-ORD-2007-
0971, by one of the following methods:
     http://www.regulations.gov: Follow the on-line

instructions for submitting comments.
     E-mail<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER>.
     Mail: Office of Environmental Information (OEI) Docket
(Mail Code: 2822T), U.S. Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460. The phone number is 202-
566-1752.
     Hand Delivery: The OEI Docket is located in the EPA
Headquarters Docket Center, Room 3334 EPA West Building, 1301
Constitution Ave., NW., Washington, DC. The EPA Docket Center Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>. Such deliveries are only accepted during
the Docket's normal hours of

operation, and special arrangements should be made for deliveries of
boxed information.
    If you provide comments by mail or hand delivery, please submit
three copies of the comments. For attachments, provide an index, number
pages consecutively with the comments, and submit an unbound original
and three copies.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-ORD-
2007-0971. Please ensure that your comments are submitted within the
specified comment period. Comments received after the closing date will
be marked ``late,'' and may only be considered if time permits. It is
EPA's policy to include all comments it receives in the public docket
without change and to make the comments available online at
http://www.regulations.gov, including any personal information provided,

unless a comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through http://www.regulations.gov or e-mail.

The http://www.regulations.gov Web site is an ``anonymous access'' system,

which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through http://www.regulations.gov,

your e-mail address will be automatically captured and included as part
of the comment that is placed in the public docket and made available
on the Internet. If you submit an electronic comment, EPA recommends
that you include your name and other contact information in the body of
your comment and with any disk or CD-ROM you submit. If EPA cannot read
your comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses. For additional
information about EPA's public docket, visit the EPA Docket Center
homepage at http://www.epa.gov/epahome/dockets.htm.

    Docket: Documents in the docket are listed in the
http://www.regulations.gov index. Although listed in the index, some

information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other materials,
such as copyrighted material, are publicly available only in hard copy.
Publicly available docket materials are available either electronically
in http://www.regulations.gov or in hard copy at the OEI Docket in the EPA

Headquarters Docket Center.

    Dated: September 26, 2007.
Rebecca Clark,
Acting Director, National Center for Environmental Assessment.
[FR Doc. E7-19638 Filed 10-3-07; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 80, Number 104 (Monday, June 1, 2015)]
[Notices]
[Page 31028]
[FR Doc No: 2015-13090]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. OR15-26-000]

NuStar Logistics, L.P.; Notice of Petition for Declaratory Order

    Take notice that on May 22, 2015, pursuant to Rule 207(a)(2) of the
Federal Energy Regulatory Commission's (Commission) Rules of Practice
and Procedure, 18 CFR 385.207(a)(2) (2014), NuStar Logistics, L.P.
(``NuStar'') filed a petition for a declaratory order seeking a
declaratory order concerning NuStar's supplemental open season held for
its South Texas Crude Oil Pipeline System Expansion Project
(``Expansion Project''). The Expansion Project involves an expansion of
NuStar's existing pipeline system that transports crude oil from
various points in the Eagle Ford shale region of South Texas to
NuStar's Corpus Christi North Beach Terminal in Nueces County, Texas,
all as more fully explained in the petition.
    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, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date.
Anyone filing a motion to intervene or protest must serve a copy of
that document on the Petitioner.
    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 5 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 email
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern time on June 22, 2015.

    Dated: May 26, 2015.
Kimberly D. Bose,
 Secretary.
[FR Doc. 2015-13090 Filed 5-29-15; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 85, Number 176 (Thursday, September 10, 2020)]
[Notices]
[Page 55905]
[FR Doc No: 2020-19944]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-89765; File No. SR-CBOE-2020-014]

Self-Regulatory Organizations; Cboe Exchange, Inc.; Notice of
Designation of Longer Period for Commission Action on Proceedings To
Determine Whether To Approve or Disapprove a Proposed Rule Change To
Adopt a Delta-Adjusted at Close Order Instruction

September 3, 2020.
    On February 18, 2020, Cboe Exchange, Inc. (``Exchange'') filed with
the Securities and Exchange Commission (``Commission''), pursuant to
Section 19(b)(1) of the Securities Exchange Act of 1934 (``Act'') \1\
and Rule 19b-4 thereunder,\2\ a proposed rule change to adopt a Delta-
Adjusted at Close order instruction that a User may apply to an order
when entering it into the System for execution in an electronic or open
outcry auction. The proposed rule change was published for comment in
the Federal Register on March 9, 2020.\3\ On April 13, 2020, the
Commission designated a longer period within which to approve the
proposed rule change, disapprove the proposed rule change, or institute
proceedings to determine whether the proposed rule change should be
disapproved.\4\ On May 12, 2020, the Exchange submitted Amendment No. 1
to the proposed rule change.\5\ On June 3, 2020, the Commission
instituted proceedings to determine whether to approve or disapprove
the proposed rule change, as modified by Amendment No. 1.\6\ The
Commission has received one comment on the proposed rule change.\7\
Section 19(b)(2) of the Act \8\ provides that, after initiating
proceedings, the Commission shall issue an order approving or
disapproving the proposed rule change not later than 180 days after the
date of publication of notice of filing the proposed rule change. The
Commission may extend the period for issuing an order approving or
disapproving the proposed rule change, however, by not more than 60
days if the Commission determines that a longer period is appropriate
and publishes the reasons for such determination. The proposed rule
change was published for notice and comment in the Federal Register on
March 9, 2020.\9\ September 5, 2020 is 180 days from that date, and
November 4, 2020 is 240 days from that date.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 88312 (March 3,
2020), 85 FR 13686 (``Notice'').
    \4\ See Securities Exchange Act Release No. 88622, 85 FR 21490
(April 17, 2020).
    \5\ See https://www.sec.gov/comments/sr-cboe-2020-014/srcboe2020014-7180918-216787.pdf.
    \6\ See Securities Exchange Act Release No. 88997, 85 FR 35351
(June 9, 2020).
    \7\ See Letter from Kurt Eckert, Partner, Wolverine Execution
Services, LLC, to Vanessa Countryman, Secretary, Commission, dated
June 24, 2020, available at https://www.sec.gov/comments/sr-cboe-2020-014/srcboe2020014-7343517-218670.pdf.
    \8\ 15 U.S.C. 78s(b)(2).
    \9\ See Notice, supra note 3.
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    The Commission finds it appropriate to designate a longer period
within which to issue an order approving or disapproving the proposed
rule change so that it has sufficient time to consider the proposed
rule change and the issues raised in the comment letters that have been
submitted in connection therewith. Accordingly, the Commission,
pursuant to Section 19(b)(2) of the Act,\10\ the Commission designates
November 4, 2020, as the date by which the Commission shall either
approve or disapprove the proposed rule change (File No. CBOE-2020-
014).
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    \10\ Id.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\11\
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    \11\ 17 CFR 200.30-3(a)(31).
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J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2020-19944 Filed 9-9-20; 8:45 am]
BILLING CODE 8011-01-P