[Federal Register Volume 80, Number 148 (Monday, August 3, 2015)]
[Notices]
[Pages 46083-46086]
[FR Doc No: 2015-18879]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-75533; File No. SR-NYSEMKT-2015-52]

Self-Regulatory Organizations; NYSE MKT LLC; Notice of Filing and
Immediate Effectiveness of Proposed Rule Change Extend the Operation of
Its New Market Model Pilot Until October 31, 2015

July 28, 2015.
    Pursuant to section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that on July 17, 2015, NYSE MKT LLC (the ``Exchange'' or ``NYSE
MKT'') 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 self-regulatory
organization. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C.78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 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 extend the operation of its New Market
Model Pilot, currently scheduled to expire on July 31, 2015, until the
earlier of Securities and Exchange Commission (``Commission'') approval
to make such pilot permanent or October 31, 2015. The text of the
proposed rule change is available on the Exchange's Web site at
www.nyse.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 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 the
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange proposes to extend the operation of its New Market
Model Pilot (``NMM Pilot'') that was adopted pursuant to its merger
with the New York Stock Exchange LLC (``NYSE'').\4\ The NMM Pilot was
approved to operate until October 1, 2009. The Exchange filed to extend
the operation of the Pilot to November 30, 2009, March 30, 2010,
September 30, 2010, January 31, 2011, August 1, 2011, January 31, 2012,
July 31, 2012, January 31, 2013, July 31, 2013, January 31, 2014, July
31, 2014, December 31, 2014, and July 31, 2015, respectively.\5\ The
Exchange now seeks to extend the operation of the NMM Pilot, currently
scheduled to expire on July 31, 2015, until the earlier of Commission
approval to make such pilot permanent or October 31, 2015.
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    \4\ NYSE Euronext acquired The Amex Membership Corporation
(``AMC'') pursuant to an Agreement and Plan of Merger, dated January
17, 2008 (the ``Merger''). In connection with the Merger, the
Exchange's predecessor, the American Stock Exchange LLC (``Amex''),
a subsidiary of AMC, became a subsidiary of NYSE Euronext called
NYSE Alternext US LLC. See Securities Exchange Act Release No. 58673
(September 29, 2008), 73 FR 57707 (October 3, 2008) (SR-NYSE-2008-60
and SR-Amex-2008-62) (approving the Merger); see also Securities
Exchange Act Release Nos. 58705 (Oct. 1, 2008), 73 FR 58995 (Oct. 8,
2008) (approving adoption of equities rules based on those of NYSE)
and 59022 (Nov. 26, 2008), 73 FR 73683 (Dec. 3, 2008) (amending
equity rules to conform to NYSE NMM Pilot rules). Subsequently, NYSE
Alternext US LLC was renamed NYSE Amex LLC, which was then renamed
NYSE MKT LLC and continues to operate as a national securities
exchange registered under section 6 of the Securities Exchange Act
of 1934, as amended (the ``Act''). See Securities Exchange Act
Release Nos. 59575 (March 13, 2009), 74 FR 11803 (March 19, 2009)
(SR-NYSEALTR-2009-24) and 67037 (May 21, 2012), 77 FR 31415 (May 25,
2012) (SR-NYSEAmex-2012-32).
    \5\ See Securities Exchange Act Release No. 60758 (October 1,
2009), 74 FR 51639 (October 7, 2009) (SR-NYSEAmex-2009-65). See also
Securities Exchange Act Release Nos. 61030 (November 19, 2009), 74
FR 62365 (November 27, 2009) (SR-NYSEAmex-2009-83) (extending Pilot
to March 30, 2010); 61725 (March 17, 2010), 75 FR 14223 (March 24,
2010) (SR-NYSEAmex-2010-28) (extending Pilot to September 30, 2010);
62820 (September 1, 2010), 75 FR 54935 (September 9, 2010) (SR-
NYSEAmex-2010-86) (extending Pilot to January 31, 2011); 63615
(December 29, 2010), 76 FR 611 (January 5, 2011) (SR-NYSEAmex-2010-
123) (extending Pilot to August 1, 2011); 64773 (June 29, 2011), 76
FR 39453 (July 6, 2011) (SR-NYSEAmex-2011-43) (extending Pilot to
January 31, 2012); 66042 (December 23, 2011), 76 FR 82326 (December
30, 2011) (SR-NYSEAmex-2011-102) (extending Pilot to July 31, 2012);
67495 (July 25, 2012), 77 FR 45406 (July 31, 2012) (SR-NYSEMKT-2012-
21) (extending the Pilot to January 31, 2013); 68559 (January 2,
2013), 78 FR 1286 (January 8, 2013) (SR-NYSEMKT-2012-84) (extending
Pilot to July 31, 2013); 69812 (June 20, 2013), 78 FR 38766 (June
27, 2013) (SR-NYSEMKT-2013-51) (extending Pilot to January 31,
2014); 71342 (January 17, 2014), 79 FR 4197 (January 24, 2014) (SR-
NYSEMKT-2014-02) (extending Pilot to July 31, 2014); 72622 (July 16,
2014), 79 FR 42600 (July 22, 2014) (SR-NYSEMKT-2014-57) (extending
Pilot to December 31, 2014); and 73946 (December 24, 2014), 80 FR 60
(January 2, 2015) (SR-NYSEMKT-2014-109) (extending Pilot to July 31,
2015).
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Background \6\
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    \6\ The information contained herein is a summary of the NMM
Pilot. See Securities Exchange Act Release No. 58845 (October 24,
2008), 73 FR 64379 (October 29, 2008) (SR-NYSE-2008-46) for a fuller
description.
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    In December 2008, the Exchange implemented significant changes to
its equities market rules, execution technology and the rights and
obligations of its equities market participants all of which were
designed to improve execution quality on the Exchange. These changes
are all elements of the Exchange's enhanced market model that it
implemented through the NMM Pilot.
    As part of the NMM Pilot, the Exchange eliminated the function of
equity specialists on the Exchange creating a new category of market
participant, the Designated Market Maker or DMM.\7\ The DMMs, like
specialists, have affirmative obligations to make an orderly market,
including continuous quoting requirements and obligations to re-enter
the market when reaching across to execute against trading interest.
Unlike specialists, DMMs have a minimum quoting requirement \8\ in
their assigned securities and no longer have a negative obligation.
DMMs are also no longer agents for public customer orders.\9\
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    \7\ See NYSE MKT Rule 103--Equities.
    \8\ See NYSE MKT Rule 104--Equities.
    \9\ See NYSE MKT Rule 60--Equities; see also NYSE MKT Rules
104--Equities and 1000--Equities.
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    In addition, the Exchange implemented a system change that allowed
DMMs to create a schedule of additional non-displayed liquidity at
various price points where the DMM is willing to interact with interest
and provide price improvement to orders in the Exchange's system. This
schedule is known as the DMM Capital Commitment Schedule (``CCS'').\10\
CCS provides the Display Book[supreg] \11\ with the amount of shares
that the DMM is willing to trade at price points outside, at and inside
the Exchange Best Bid or Best Offer (``BBO''). CCS interest is separate
and distinct from other DMM interest in that it serves as the interest
of last resort.
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    \10\ See NYSE MKT Rule 1000--Equities.
    \11\ The Display Book system is an order management and
execution facility. The Display Book system receives and displays
orders to the DMMs, contains the order information, and provides a
mechanism to execute and report transactions and publish the results
to the Consolidated Tape. The Display Book system is connected to a
number of other Exchange systems for the purposes of comparison,
surveillance, and reporting information to customers and other
market data and national market systems.
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    The NMM Pilot further modified the logic for allocating executed
shares among market participants having trading interest at a price
point upon execution of incoming orders. The modified logic rewards
displayed orders that establish the Exchange's BBO. During the
operation of the NMM Pilot, orders or portions thereof that establish
priority \12\ retain that priority until the portion of the order that
established priority is exhausted. Where no one order has established
priority, shares are distributed among all market participants on
parity.
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    \12\ See NYSE MKT Rule 72(a)(ii)--Equities.
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    The NMM Pilot was originally scheduled to end operation on October
1, 2009, or such earlier time as the Commission may determine to make
the rules permanent. The Exchange filed to extend the operation of the
Pilot on several occasions \13\ in order to prepare a rule filing
seeking permission to make the above described changes permanent. The
Exchange is currently still preparing such formal submission but does
not expect that filing to be completed and approved by the Commission
before July 31, 2015.\14\
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    \13\ See supra note 5.
    \14\ The NYSE has submitted a proposed rule change to make the
NYSE NMM Pilot permanent. See Securities Exchange Act Release No.
75153 (June 11, 2015), 80 FR 34717 (June 17, 2015) (SR-NYSE-2015-
26).
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Proposal To Extend the Operation of the NMM Pilot
    The Exchange established the NMM Pilot to provide incentives for
quoting, to enhance competition among the existing group of liquidity
providers and to add a new competitive market participant. The Exchange
believes that the NMM Pilot allows the Exchange to provide its market
participants with a trading venue that utilizes an enhanced market
structure to encourage the addition of liquidity, facilitate the
trading of larger orders more efficiently and operates to reward
aggressive liquidity providers. As such, the Exchange believes that the
rules governing the NMM Pilot should be made permanent. Through this
filing the Exchange seeks to extend the current operation of the NMM
Pilot until October 31, 2015, in order to allow the Exchange time to
formally submit a filing to the Commission to convert the pilot rules
to permanent rules.
    The proposed change is not otherwise intended to address any other
issues

and the Exchange is not aware of any problems that member organizations
would have in complying with the proposed change.
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 prevent fraudulent and manipulative acts and practices,
to promote just and equitable principles of trade, to foster
cooperation and coordination with persons engaged in regulating,
clearing, settling, processing information with respect to, and
facilitating transactions in securities, to remove impediments to, and
perfect the mechanisms of, a free and open market and a national market
system and, in general, to protect investors and the public interest
and because it is not designed to permit unfair discrimination between
customers, issuers, brokers, or dealers.
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    \15\ 15 U.S.C. 78f(b).
    \16\ 15 U.S.C. 78f(b)(5).
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    The Exchange believes the proposed rule change is designed to
prevent fraudulent and manipulative acts and practices and to promote
just and equitable principles of trade because it seeks to extend a
pilot program that has already been approved by the Commission. The
Exchange believes the proposed rule change is designed to facilitate
transactions in securities and to remove impediments to, and perfect
the mechanisms of, a free and open market and a national market system
because the NMM Pilot provides its market participants with a trading
venue that utilizes an enhanced market structure to encourage the
addition of liquidity, facilitate the trading of larger orders more
efficiently and operates to reward aggressive liquidity providers.
Moreover, requesting an extension of the NMM Pilot will permit adequate
time for: (i) The Exchange to prepare and submit a filing to make the
rules governing the NMM Pilot permanent; (ii) public notice and
comment; and (iii) completion of the 19b-4 approval process. Finally,
the Exchange believes that it is subject to significant competitive
forces, as described below in the Exchange's statement regarding the
burden on competition. For these reasons, the Exchange believes that
the proposal is consistent with the Act.

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

    In accordance with section 6(b)(8) of the Act,\17\ the Exchange
believes that the proposed rule change would not impose any burden on
competition that is not necessary or appropriate in furtherance of the
purposes of the Act. The Exchange believes that extending the operation
of the NMM Pilot will enhance competition among liquidity providers and
thereby improve execution quality on the Exchange. The Exchange will
continue to monitor the efficacy of the program during the proposed
extended pilot period.
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    \17\ 15 U.S.C. 78f(b)(8).
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    Finally, the Exchange notes that it operates in a highly
competitive market in which market participants can readily favor
competing venues. In such an environment, the Exchange must continually
review, and consider adjusting the services it offers and the
requirements it imposes to remain competitive with other U.S. equity
exchanges. For the reasons described above, the Exchange believes that
the proposed rule change reflects this competitive environment.

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

    The Exchange has filed the proposed rule change pursuant to section
19(b)(3)(A)(iii) of the Act \18\ and Rule 19b-4(f)(6) thereunder.\19\
Because the proposed rule change does not: (i) Significantly affect the
protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) become operative prior to
30 days from the date on which it was filed, or such shorter time as
the Commission may designate, if consistent with the protection of
investors and the public interest, the proposed rule change has become
effective pursuant to section 19(b)(3)(A) of the Act and Rule 19b-
4(f)(6)(iii) thereunder.
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    \18\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \19\ 17 CFR 240.19b-4(f)(6).
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    A proposed rule change filed under Rule 19b-4(f)(6) \20\ normally
does not become operative prior to 30 days after the date of the
filing. However, pursuant to Rule 19b-4(f)(6)(iii),\21\ the Commission
may designate a shorter time if such action is consistent with the
protection of investors and the public interest. The Exchange has asked
the Commission to waive the 30-day operative delay so that the proposal
may become operative immediately upon filing. The Exchange notes that
waiving the 30-day operative delay is consistent with the protection of
investors and the public interest. The Exchange believes that waiver
will ensure that member organizations and the public can continue to
benefit from the pilot program without interruption after July 31,
2015. The Commission hereby waives the 30-day operative delay and
designates the proposal operative upon filing.\22\
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    \20\ 17 CFR 240.19b-4(f)(6).
    \21\ 17 CFR 240.19b-4(f)(6)(iii).
    \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 such proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings under
section 19(b)(2)(B) \23\ of the Act to determine whether the proposed
rule change should be approved or disapproved.
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    \23\ 15 U.S.C. 78s(b)(2)(B).
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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-NYSEMKT-2015-52 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-NYSEMKT-2015-52. This
file number should be included on the subject line if email is used. To
help the Commission process and review your

comments more efficiently, please use only one method. The Commission
will post all comments on the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent
amendments, all written statements with respect to the proposed rule
change that are filed with the Commission, and all written
communications relating to the proposed rule change between the
Commission and any person, other than those that may be withheld from
the public in accordance with the provisions of 5 U.S.C. 552, will be
available for Web site viewing and printing in the Commission's Public
Reference Room, 100 F Street NE., Washington, DC 20549, on official
business days between the hours of 10:00 a.m. and 3:00 p.m. Copies of
the filing also will be available for inspection and copying at the
principal office of the Exchange. All comments received will be posted
without change; the Commission does not edit personal identifying
information from submissions. You should submit only information that
you wish to make available publicly. All submissions should refer to
File Number SR- NYSEMKT-2015-52, and should be submitted on or before
August 24, 2015.
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    \24\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\24\
Robert W. Errett,
Deputy Secretary.
[FR Doc. 2015-18879 Filed 7-31-15; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 87, Number 239 (Wednesday, December 14, 2022)]
[Rules and Regulations]
[Pages 76418-76425]
[FR Doc No: 2022-24106]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 516, 520, 522, 528, and 558

[Docket No. FDA-2022-N-0002]

New Animal Drugs; Approval of New Animal Drug Applications;
Change of Sponsor; Change of Sponsor Address

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendments.

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SUMMARY: The Food and Drug Administration (FDA or we) is amending the
animal drug regulations to reflect application-related actions for new
animal drug applications (NADAs), abbreviated new animal drug
applications (ANADAs), and conditionally approved new animal drug
applications (cNADAs) during April, May, and June 2022. FDA is
informing the public of the availability of summaries of the basis of
approval and of environmental review documents, where applicable. The
animal drug regulations are also being amended to improve the accuracy
and readability of the regulations.

DATES: This rule is effective December 14, 2022.

FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for
Veterinary Medicine (HFV-6), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

I. Approvals

    FDA is amending the animal drug regulations to reflect approval
actions for NADAs, ANADAs, and cNADAs during April, May, and June 2022,
as listed in table 1. In addition, FDA is informing the public of the
availability, where applicable, of documentation of environmental
review required under the National Environmental Policy Act (NEPA) and,
for actions requiring review of safety or effectiveness data, summaries
of the basis of approval (FOI Summaries) under the Freedom of
Information Act (FOIA). These public documents may be seen in the
office of the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852,
between 9 a.m. and 4 p.m., Monday through Friday,<PHONE_NUMBER>. Persons
with access to the internet may obtain these documents at the CVM FOIA
Electronic Reading Room: https://www.fda.gov/about-fda/center-veterinary-medicine/cvm-foia-electronic-reading-room. Marketing
exclusivity and patent information may be accessed in FDA's
publication, Approved Animal Drug Products Online (Green Book) at:
https://www.fda.gov/animal-veterinary/products/approved-animal-drug-products-green-book.
    FDA has verified the website addresses as of the date this document
publishes in the Federal Register, but websites are subject to change
over time.

Table 1--Original and Supplemental NADAs, ANADAs, and cNADAs Approved During April, May, and June 2022 Requiring Evidence of Safety and/or Effectiveness
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                21 CFR
           Approval date             File No.          Sponsor              Product name       Effect of the action     Public  documents       section
--------------------------------------------------------------------------------------------------------------------------------------------------------
April 28, 2022....................     141-137  Pharmgate, Inc., 1800  PENNITRACIN MD         Supplemental approval  FOI Summary............      558.76
                                                 Sir Tyler Dr.,         (bacitracin Type A     for the prevention
                                                 Wilmington, NC 28405.  medicated article).    of mortality caused
                                                                                by necrotic
                                                                                enteritis associated
                                                                                with Clostridium
                                                                                perfringens in
                                                                                broiler and
                                                                                replacement chickens.
June 16, 2022.....................     141-556  Boehringer Ingelheim   VETMEDIN-CA1           Conditional approval   FOI Summary............    516.1780
                                                 Animal Health USA,     (pimobendan)           for the delay of
                                                 Inc., 3239 Satellite   Chewable Tablets.      onset of congestive
                                                 Blvd., Duluth, GA                             heart failure in
                                                 30096.                                        dogs with Stage B2
                                                                                preclinical
                                                                                myxomatous mitral
                                                                                valve disease.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Also, FDA is amending the animal drug regulations to reflect
approval of supplemental applications, as listed in table 2, to change
the marketing status of dosage form antimicrobial animal drug products
from over-the-counter (OTC) to veterinary prescription (Rx). These
applications were submitted in voluntary compliance with the goals of
the FDA Center for Veterinary Medicine's (CVM's) Judicious Use
Initiative as identified by guidance for industry #263,
``Recommendations for Sponsors of Medically Important Antimicrobial
Drugs Approved for Use in Animals to Voluntarily Bring Under Veterinary
Oversight All Products That Continue to be Available Over-the-
Counter,'' June 11, 2021 (https://www.fda.gov/media/130610/download).

 Table 2--Supplemental Applications Approved During April, May, and June 2022 To Change the Marketing Status of
                                Antimicrobial Animal Drug Products From OTC to Rx
----------------------------------------------------------------------------------------------------------------
                                                                                21 CFR
           Approval date              File No.           Sponsor                 Product name           section
----------------------------------------------------------------------------------------------------------------
May 31, 2022.......................     008-769  Zoetis Inc., 333        TERRAMYCIN (oxytetracycline   522.1662a
                                                  Portage St.,            hydrochloride) Injectable
                                                  Kalamazoo, MI 49007.    Solution; LIQUAMYCIN
                                                                          (oxytetracycline
                                                                          hydrochloride) Injectable
                                                                          Solution.
June 7, 2022.......................     007-981  Do....................  SOXISOL (sulfisoxazole)        520.2330
                                                                          Tablets.
----------------------------------------------------------------------------------------------------------------

II. Changes of Sponsorship

    The sponsors of the following approved applications have informed
FDA that they have transferred ownership of, and all rights and
interest in, the applications to another sponsor, as listed in table 3.

                        Table 3--Changes of Sponsorship During April, May, and June 2022
----------------------------------------------------------------------------------------------------------------
                                                                                21 CFR
             File No.                   Product name      Transferring sponsor       New sponsor        section
----------------------------------------------------------------------------------------------------------------
119-688...........................  CEFA-TABS             Boehringer Ingelheim  HQ Specialty Pharma      520.314
                                     (cefadroxil)          Animal Health USA,    Corp., 120 Rte. 17
                                     Tablets.              Inc., 3239            North, Suite 130,
                                                           Satellite Blvd.,      Paramus, NJ 07652.
                                                           Duluth, GA 30096.
140-684...........................  CEFA-DROPS            Do..................  Do..................     520.314
                                     (cefadroxil) Powder
                                     for Suspension.
141-217...........................  ZEUTERIN (zinc        Ark Sciences, Inc.,   Aiping                  522.2690
                                     gluconate)            1101 East 33rd St.,   Pharmaceutical,
                                     Injectable Solution.  Suite B304,           Inc., 350 W
                                                           Baltimore, MD 21218.  Wireless Blvd.,
                                                                                Hauppauge, NY 11788.
141-551...........................  ZENALPHA              Vetcare Oy, P.O. Box  Dechra, Ltd.,           522.1338
                                     (medetomidine         26 (Liedontie 45),    Snaygill Industrial
                                     hydrochloride and     M[auml]nts[auml]l[a   Estate, Keighley
                                     vatinoxan             uml], Uusimaa,        Rd., Skipton, North
                                     hydrochloride)        04601, Finland.       Yorkshire, BD23
                                     Injectable Solution.                        2RW, United Kingdom.
----------------------------------------------------------------------------------------------------------------

    Following these changes of sponsorship, Ark Sciences, Inc. and
Vetcare Oy are no longer the sponsor of an approved application.
Accordingly, the drug labeler codes for these firms will be removed
from Sec.  510.600 (21 CFR 510.600).

III. Change of Sponsor Address

    Anivive Lifesciences, Inc., 3250 Airflite Way, Suite 400, Long
Beach, CA 90807 has informed FDA that it has changed its address to
3777 Worsham Ave. Long Beach, CA 90808. As provided in the regulatory
text, Sec.  510.600 is amended to reflect this change.

IV. Technical Amendments

    FDA is making the following amendments to improve the accuracy of
the animal drug regulations:
     21 CFR 510.600 is amended to remove Ark Sciences, Inc.,
and Vetcare Oy from the list of sponsors of approved applications and
to revise the address for Anivive Lifesciences, Inc. A punctuation
change is made in the codified name for Ve[aacute]toquinol USA, Inc.
     21 CFR 520.563 is amended to reflect the correct section
title for diatrizoate oral solution.
     21 CFR 520.2640 is amended to reflect sponsors' container
contents and the dosage in parts per million of tylosin tartrate
soluble powder for use in drinking water of turkeys and swine.
     21 CFR 522.955 is amended to reflect drug labeler codes of
application sponsors and to revise a pathogen name for florfenicol
injectable solution in cattle.
     21 CFR 522.2471 is amended to reflect a revised withdrawal
period and human food safety warnings for tilmicosin injectable
solution in sheep.
     The heading for Part 528 is revised to reflect a more
accurate title.
     21 CFR 558.95 is amended to reflect revised classes of
cattle for use of bambermycins medicated feeds.
     21 CFR 558.128 is amended to reflect approved
incorporation rates for

chlortetracycline medicated feeds for cattle.
     21 CFR 558.342 is amended to reflect all sponsors of
approved applications for use of melengestrol medicated feeds in
heifers.
     21 CFR 558.450 is amended to reflect revised residue
warnings for use of oxytetracycline medicated feeds in cattle.
     21 CFR 558.455 is amended to reflect a revised indication
for use of oxytetracycline with neomycin in medicated cattle feeds and
an updated format.
     21 CFR 558.575 is amended to reflect approved
incorporations rates for use of sulfadimethoxine and ormetoprim in
medicated feeds for salmonids and catfish.

V. Legal Authority

    This final rule is issued under section 512(i) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360b(i)), which requires
Federal Register publication of ``notice[s] . . . effective as a
regulation,'' of the conditions of use of approved new animal drugs.
This rule sets forth technical amendments to the regulations to codify
recent actions on approved new animal drug applications and corrections
to improve the accuracy of the regulations, and as such does not impose
any burden on regulated entities.
    Although denominated a rule pursuant to the FD&C Act, this document
does not meet the definition of ``rule'' in 5 U.S.C. 804(3)(A) because
it is a ``rule of particular applicability.'' Therefore, it is not
subject to the congressional review requirements in 5 U.S.C. 801-808.
Likewise, this is not a rule subject to Executive Order 12866, which
defines a rule as ``an agency statement of general applicability and
future effect, which the agency intends to have the force and effect of
law, that is designed to implement, interpret, or prescribe law or
policy or to describe the procedure or practice requirements of an
agency.''

List of Subjects

21 CFR Part 510

    Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.

21 CFR Part 516

    Administrative practice and procedure, Animal drugs, Confidential
business information, Reporting and recordkeeping requirements.

21 CFR Parts 520, 522, and 528

    Animal drugs.

21 CFR Part 558

    Animal drugs, Animal feeds.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts
510, 516, 520, 522, 528, and 558 are amended as follows:

PART 510--NEW ANIMAL DRUGS

0
1. The authority citation for part 510 continues to read as follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.

0
2. In Sec.  510.600:
0
a. In the table in paragraph (c)(1), remove the entries for ``Ark
Sciences, Inc.'' and ``Vetcare Oy''; revise the entries for ``Anivive
Lifesciences, Inc.''; and ``Ve[aacute]toquinol USA, Inc.''; and add in
alphabetical order an entry for ``Aiping Pharmaceutical, Inc.''; and
0
b. In the table in paragraph (c)(2), add an entry for ``011788'';
revise the entries for ``017030'' and ``086121''; and remove the
entries for ``076175'' and ``086155''.
    The revisions and additions read as follows:

Sec.  510.600  Names, addresses, and drug labeler codes of sponsors of
approved applications.

* * * * *
    (c) * * *
    (1) * * *

------------------------------------------------------------------------
                                                           Drug labeler
                  Firm name and address                        code
------------------------------------------------------------------------

                              * * * * * * *
Aiping Pharmaceutical, Inc., 350W Wireless Blvd.,                 011788
 Hauppauge, NY 11788....................................

                              * * * * * * *
Anivive Lifesciences, Inc., 3777 Worsham Ave., Long               086121
 Beach, CA 90808........................................

                              * * * * * * *
Vetoquinol USA, Inc., 4250 N Sylvania Ave., Fort Worth,           017030
 TX 76137...............................................

                              * * * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
    Drug labeler code                  Firm name and address
------------------------------------------------------------------------

                              * * * * * * *
011788..................  Aiping Pharmaceutical, Inc., 350W Wireless
                           Blvd., Hauppauge, NY 11788.

                              * * * * * * *
017030..................  Vetoquinol USA, Inc., 4250 N. Sylvania Ave.,
                           Fort Worth, TX 76137.

                              * * * * * * *
086121..................  Anivive Lifesciences, Inc., 3777 Worsham Ave.,
                           Long Beach, CA 90808.

                              * * * * * * *
------------------------------------------------------------------------

PART 516--NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES

0
3. The authority citation for part 516 continues to read as follows:

    Authority: 21 U.S.C. 360ccc-1, 360ccc-2, 371.

0
4. Add Sec.  516.1780 to subpart E to read as follows:

Sec.  516.1780  Pimobendan.

    (a) Specifications. Each chewable tablet contains 1.25, 2.5, 5, or
10 milligrams (mg) pimobendan.
    (b) Sponsor. See No. 000010 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. Administer orally at a total
daily dose of 0.23 mg per pound (0.5 mg per kilogram) body weight,
using a suitable combination of whole or half tablets. The total daily
dose should be divided into two portions administered approximately 12
hours apart.
    (2) Indications for use in dogs. For the delay of onset of
congestive heart failure in dogs with Stage B2 preclinical myxomatous
mitral valve disease (2019 ACVIM Consensus Statement). Stage B2
preclinical myxomatous mitral valve disease (MMVD) refers to dogs with
asymptomatic MMVD that have a moderate or loud mitral murmur due to
mitral regurgitation and cardiomegaly.
    (3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian. It is a violation of Federal law
to use this product other than as directed in the labeling.

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
5. The authority citation for part 520 continues to read as follows:

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

Sec.  520.314  [Amended]

0
6. In Sec.  520.314, in paragraph (b), remove ``000010'' and in its
place add ``042791''.

0
7. In Sec.  520.563, revise the section heading to read as follows:

Sec.  520.563   Diatrizoate.

* * * * *

0
8. In Sec.  520.2330, amend paragraph (c)(3) by adding a sentence to
the end of the paragraph.

Sec.  520.2330  Sulfisoxazole tablets.

* * * * *
    (c) * * *
    (3) * * * Federal law restricts this drug to use by or on the order
of a licensed veterinarian.

0
9. In Sec.  520.2640, revise paragraphs (a), (b), (e)(2)(i), and (3)(i)
to read as follows:

Sec.  520.2640  Tylosin.

    (a) Specifications. Each container of soluble powder contains
tylosin tartrate equivalent to:
    (1) 100 grams (g) tylosin base, or
    (2) 256 g tylosin base.
    (b) Sponsors. See sponsors in Sec.  510.600(c) of this chapter for
use as in paragraph (e) of this section:
    (1) Nos. 016592 and 058198 for use of the 100-g container as in
paragraph (e) of this section
    (2) No. 061133 for use of the 100-or 256-g container as in
paragraphs (e)(1)(i)(A), (e)(1)(ii), (e)(2), (e)(3), and (e)(4) of this
section.
* * * * *
    (e) * * *
    (2) * * *
    (i) Amount. 2 grams per gallon (528 ppm) for 2 to 5 days as the
sole source of drinking water. Treated turkeys should consume enough
medicated drinking water to provide 60 mg tylosin per pound of body
weight per day.
* * * * *
    (3) * * *
    (i) Amount. 250 mg per gallon (66 ppm) as the only source of
drinking water for 3 to 10 days, depending on the severity of the
condition being treated.
* * * * *

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

0
10. The authority citation for part 522 continues to read as follows:

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

0
11. In Sec.  522.955, revise paragraphs (b)(3), (d)(1)(ii)(A)(2),
(d)(1)(ii)(B)(2), and (d)(1)(ii)(C) to read as follows:

Sec.  522.955  Florfenicol.

* * * * *
    (b) * * *
    (3) Nos. 058005 and 058198 for use of product described in
paragraph (a)(2) of this section as in paragraph (d)(1)(ii) of this
section.
* * * * *
    (d) * * *
    (1) * * *
    (ii) * * *
    (A) * * *
    (2) Indications for use. For treatment of BRD associated with
Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni.
For treatment of bovine interdigital phlegmon (foot rot, acute
interdigital necrobacillosis, infectious pododermatitis) associated
with Fusobacterium necrophorum and Bacteroides melaninogenicus.
    (B) * * *
    (2) Indications for use. For control of respiratory disease in
cattle at high risk of developing BRD associated with Mannheimia
haemolytica, Pasteurella multocida, and Histophilus somni.
    (C) Limitations. Animals intended for human consumption must not be
slaughtered within 28 days of the last intramuscular treatment. Nos.
000061, 058005, and 058198: Animals intended for human consumption must
not be slaughtered within 38 days of subcutaneous treatment. No.
055529: Animals intended for human consumption must not be slaughtered
within 33 days of subcutaneous treatment. This product is not approved
for use in female dairy cattle 20 months of age or older, including dry
dairy cows. Use in these cattle may cause drug residues in milk and/or
in calves born to these cows. A withdrawal period has not been
established in pre-ruminating calves. Do not use in calves to be
processed for veal. Federal law restricts this drug to use by or on the
order of a licensed veterinarian.
* * * * *

Sec.  522.1338  [Amended]

0
12. In 522.1338, in paragraph (b), remove ``086155'' and in its place
add ``043264''.

0
13. In Sec.  522.1662a, revise paragraph (e)(1); add paragraphs
(e)(3)(i)(D), (e)(3)(ii)(C), and (e)(3)(iii)(D); and remove paragraphs
(e)(3)(iv) through (vii) to read as follows:

Sec.  522.1662a  Oxytetracycline hydrochloride injection.

* * * * *
    (e) * * *
    (1) Specifications. Each milliliter of solution contains 50
milligrams (mg) oxytetracycline hydrochloride.
* * * * *
    (3) * * *
    (i) * * *
    (D) Treatment must be discontinued at least 22 days prior to
slaughter. Not for use in lactating dairy animals. Federal law
restricts this drug to use by or on the order of a licensed
veterinarian.
    (ii) * * *
    (C) Treatment must be discontinued at least 22 days prior to
slaughter. Federal law restricts this drug to use by or on the order of
a licensed veterinarian.
    (iii) * * *
    (D) Do not administer to laying hens unless the eggs are used for
hatching only. Treatment must be discontinued at least 5 days prior to
slaughter. Federal law restricts this drug to use by or on the order of
a licensed veterinarian.
* * * * *

0
14. In Sec.  522.2471, revise paragraph (e)(2)(iii) to read as follows:

Sec.  522.2471  Tilmicosin.

* * * * *
    (e) * * *
    (2) * * *
    (iii) Limitations. Animals intended for human consumption must not
be slaughtered within 42 days of the last treatment. Not for use in
lactating ewes producing milk for human consumption.

Sec.  522.2690  [Amended]

0
15. In 522.2690, in paragraph (b), remove ``076175'' and in its place
add ``011788''.

PART 528--INTENTIONAL GENOMIC ALTERATIONS IN ANIMALS

0
16. The authority citation for part 528 continues to read as follows:

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

0
17. Revise the heading for part 528 to read as set forth above.

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

0
18. The authority citation for part 558 continues to read as follows:

    Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.

0
19. In Sec.  558.95, revise paragraphs (e)(4)(i) and (ii) to read as
follows:

Sec.  558.95  Bambermycins.

* * * * *
    (e) * * *
    (4) * * *

----------------------------------------------------------------------------------------------------------------
        Bambermycins in grams/ton               Indications for use               Limitations           Sponsors
----------------------------------------------------------------------------------------------------------------
(i) 1 to 4...............................  Growing beef steers and       Feed continuously at a rate      016592
                                            heifers fed in confinement    of 10 to 20 milligrams per
                                            for slaughter: For            head per day.
                                            increased rate of weight
                                            gain and improved feed
                                            efficiency.
(ii) 2 to 80.............................  Growing beef steers and       Feed continuously on a hand-     016592
                                            heifers on pasture            fed basis at a rate of 10
                                            (stocker, feeder, and         to 40 milligrams per head
                                            slaughter), and replacement   per day in 1 to 10 pounds
                                            beef and dairy heifers on     of supplemental Type C
                                            pasture: For increased rate   medicated feed.
                                            of weight gain.
----------------------------------------------------------------------------------------------------------------

* * * * *

0
20. In Sec.  558.128, revise paragraphs (e)(4)(x), (xi), (xiii), (xxx),
and (xxxi) to read as follows:

Sec.  558.128  Chlortetracycline.

* * * * *
    (e) * * *
    (4) * * *

----------------------------------------------------------------------------------------------------------------
    Chlortetracycline amount       Combination in grams/ton   Indications for use      Limitations      Sponsor
----------------------------------------------------------------------------------------------------------------

                                                * * * * * * * * *
(x) 500 to 2,000 g/ton to         Laidlomycin, 5............  Cattle fed in        Feed continuously      054771
 provide 10 mg/lb of body weight                               confinement for      at a rate of 30
 daily.                                                        slaughter: For       to 75 mg
                                                               treatment of         laidlomycin
                                                               bacterial            propionate
                                                               enteritis caused     potassium per
                                                               by Escherichia       head per day for
                                                               coli and bacterial   not more than 5
                                                               pneumonia caused     days. A
                                                               by Pasteurella       withdrawal period
                                                               multocida            has not been
                                                               organisms            established for
                                                               susceptible to       this product in
                                                               chlortetracycline;   pre-ruminating
                                                               and for increased    calves. Do not
                                                               rate of weight       use in calves to
                                                               gain and improved    be processed for
                                                               feed efficiency.     veal. See Sec.
                                                                                558.305(d) of
                                                                                this chapter.
                                                                                Laidlomycin as
                                                                                provided by No.
                                                                                054771 in Sec.
                                                                                510.600(c) of
                                                                                this chapter.
(xi) 500 to 4,000 g/ton to        Laidlomycin, 5 to 10......  Cattle fed in        Feed continuously      054771
 provide 10 mg/lb of body weight                               confinement for      at a rate of 30
 daily.                                                        slaughter: For       to 75 mg
                                                               treatment of         laidlomycin
                                                               bacterial            propionate
                                                               enteritis caused     potassium per
                                                               by Escherichia       head per day for
                                                               coli and bacterial   not more than 5
                                                               pneumonia caused     days. A
                                                               by Pasteurella       withdrawal period
                                                               multocida            has not been
                                                               organisms            established for
                                                               susceptible to       this product in
                                                               chlortetracycline;   pre-ruminating
                                                               and for improved     calves. Do not
                                                               feed efficiency.     use in calves to
                                                                                be processed for
                                                                                veal. See Sec.
                                                                                558.305(d) of
                                                                                this chapter.
                                                                                Laidlomycin as
                                                                                provided by No.
                                                                                054771 in Sec.
                                                                                510.600(c) of
                                                                                this chapter.

                                                * * * * * * * * *
(xiii) 500 to 1,200 g/ton to      Lasalocid, 25 to 30.......  Cattle fed in        Feed continuously      054771
 provide 10 mg/lb of body weight                               confinement for      in complete feed
 daily.                                                        slaughter: For       to provide 10 mg
                                                               treatment of         chlortetracycline
                                                               bacterial            per lb body
                                                               enteritis caused     weight and not
                                                               by Escherichia       less than 250 mg
                                                               coli and bacterial   or more than 360
                                                               pneumonia caused     mg lasalocid per
                                                               by Pasteurella       head per day. Do
                                                               multocida            not allow horses
                                                               organisms            or other equines
                                                               susceptible to       access to feeds
                                                               chlortetracycline;   containing
                                                               and for increased    lasalocid. A
                                                               rate of weight       withdrawal period
                                                               gain and improved    has not been
                                                               feed efficiency.     established for
                                                                                this product in
                                                                                pre-ruminating
                                                                                calves. Do not
                                                                                use in calves to
                                                                                be processed for
                                                                                veal. See Sec.
                                                                                558.311(d) of
                                                                                this chapter.
                                                                                Lasalocid as
                                                                                provided by No.
                                                                                054771 in Sec.
                                                                                510.600(c) of
                                                                                this chapter.

                                                * * * * * * * * *
(xxx) 23.3 to 58.3 g/ton to       Laidlomycin, 5............  Cattle fed in        Feed continuously      054771
 provide 350 mg/head/day.                                      confinement for      at a rate of 30
                                                               slaughter: For       to 75 mg
                                                               control of           laidlomycin
                                                               bacterial            propionate
                                                               pneumonia            potassium per
                                                               associated with      head per day. A
                                                               shipping fever       withdrawal period
                                                               complex caused by    has not been
                                                               Pasteurella spp.     established for
                                                               susceptible to       this product in
                                                               chlortetracycline;   pre-ruminating
                                                               and for increased    calves. Do not
                                                               rate of weight       use in calves to
                                                               gain and improved    be processed for
                                                               feed efficiency.     veal. See Sec.
                                                                                558.305(d) of
                                                                                this chapter.
                                                                                Laidlomycin as
                                                                                provided by No.
                                                                                054771 in Sec.
                                                                                510.600(c) of
                                                                                this chapter.

(xxxi) 14.6 to 116.7 g/ton to     Laidlomycin, 5 to 10......  Cattle fed in        Feed continuously      054771
 provide 350 mg/head/day.                                      confinement for      at a rate of 30
                                                               slaughter: For       to 75 mg
                                                               control of           laidlomycin
                                                               bacterial            propionate
                                                               pneumonia            potassium per
                                                               associated with      head per day. A
                                                               shipping fever       withdrawal period
                                                               complex caused by    has not been
                                                               Pasteurella spp.     established for
                                                               susceptible to       this product in
                                                               chlortetracycline;   pre-ruminating
                                                               and for improved     calves. Do not
                                                               feed efficiency.     use in calves to
                                                                                be processed for
                                                                                veal. See Sec.
                                                                                558.305(d) of
                                                                                this chapter.
                                                                                Laidlomycin as
                                                                                provided by No.
                                                                                054771 in Sec.
                                                                                510.600(c) of
                                                                                this chapter.

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *

0
21. In Sec.  558.342, revise paragraph (e)(1)(ii) to read as follows:

Sec.  558.342  Melengestrol.

* * * * *
    (e) * * *
    (1) * * *

----------------------------------------------------------------------------------------------------------------
  Melengestrol  acetate in  mg/
            head/day               Combination  in grams/ton  Indications for use      Limitations      Sponsor
----------------------------------------------------------------------------------------------------------------

                                                * * * * * * * * *
(ii) 0.5........................  ..........................  Heifers intended     Administer 0.5 to      016592
                                                               for breeding: For    2.0 lb/head/day       054771
                                                               suppression of       of Type C feed        058198
                                                               estrus (heat).       containing 0.25
                                                                                to 1.0 mg
                                                                                melengestrol
                                                                                acetate/lb to
                                                                                provide 0.5 mg
                                                                                melengestrol
                                                                                acetate/head/day.
                                                                                Do not exceed 24
                                                                                days of feeding.

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *

0
22. In Sec.  558.450:
0
a. Revise paragraph (e)(4)(i);
0
b. Redesignate paragraphs (e)(4)(ii) through (v) as paragraphs
(e)(4)(iii) through (vi);
0
c. Add new paragraph (e)(4)(ii); and
0
d. Revise newly redesignated paragraphs (e)(4)(iii) and (vi).
    The addition and revisions read as follows:

Sec.  558.450  Oxytetracycline.

* * * * *
    (e) * * *
    (4) * * *

----------------------------------------------------------------------------------------------------------------
     Oxytetracycline amount        Combination in grams/ton   Indications for use      Limitations      Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 10 mg/lb of body weight       ..........................  Calves and beef and  Feed continuously      066104
 daily.                                                        nonlactating dairy   for 7 to 14 days.     069254
                                                               cattle: For          This drug product
                                                               treatment of         is not approved
                                                               bacterial            for use in female
                                                               enteritis caused     dairy cattle 20
                                                               by Escherichia       months of age or
                                                               coli and bacterial   older, including
                                                               pneumonia            dry dairy cows.
                                                               (shipping fever      Use in these
                                                               complex) caused by   cattle may cause
                                                               Pasteurella          drug residues in
                                                               multocida            milk and/or in
                                                               susceptible to       calves born to
                                                               oxytetracycline.     these cows. For
                                                                                No. 069254,
                                                                                withdraw 5 days
                                                                                before slaughter.
                                                                                For No. 066104,
                                                                                zero-day
                                                                                withdrawal period.
(ii) 10 mg/lb of body weight      ..........................  Calves: For          Feed continuously      066104
 daily.                                                        treatment of         for 7 to 14 days      069254
                                                               bacterial            in milk replacer
                                                               enteritis caused     or starter feed.
                                                               by E. coli           This drug product
                                                               susceptible to       is not approved
                                                               oxytetracycline.     for use in female
                                                                                dairy cattle 20
                                                                                months of age or
                                                                                older, including
                                                                                dry dairy cows.
                                                                                Use in these
                                                                                cattle may cause
                                                                                drug residues in
                                                                                milk and/or in
                                                                                calves born to
                                                                                these cows. For
                                                                                No. 069254,
                                                                                withdraw 5 days
                                                                                before slaughter.
                                                                                For No. 066104,
                                                                                zero-day
                                                                                withdrawal period.
(iii) 75 mg/head/day............  ..........................  Growing cattle       Feed continuously.     066104
                                                               (over 400 lb): For   This drug product     069254
                                                               reduction of         is not approved
                                                               incidence of liver   for use in female
                                                               abscesses.           dairy cattle 20
                                                                                months of age or
                                                                                older, including
                                                                                dry dairy cows.
                                                                                Use in these
                                                                                cattle may cause
                                                                                drug residues in
                                                                                milk and/or in
                                                                                calves born to
                                                                                these cows.

                                               * * * * * * * * * *
(vi) 0.5 to 2.0 g/head/day......  ..........................  Cattle: For          Feed 3 to 5 days       066104
                                                               prevention and       before and after      069254
                                                               treatment of the     arrival in
                                                               early stages of      feedlots. This
                                                               shipping fever       drug product is
                                                               complex.             not approved for
                                                                                use in female
                                                                                dairy cattle 20
                                                                                months of age or
                                                                                older, including
                                                                                dry dairy cows.
                                                                                Use in these
                                                                                cattle may cause
                                                                                drug residues in
                                                                                milk and/or in
                                                                                calves born to
                                                                                these cows.
----------------------------------------------------------------------------------------------------------------

* * * * *

0
23. In Sec.  558.455:
0
a. Redesignate paragraphs (e)(1)(ii) through (iv) as paragraphs
(e)(1)(i) through (iii);
0
b. Redesignate paragraphs (e)(2)(ii) through (iv) as paragraphs
(e)(2)(i) through (iii);
0
c. Revise paragraphs (e)(3) and (4); and
0
d. Add paragraph (e)(5).
    The revisions and addition read as follows:

Sec.  558.455  Oxytetracycline and neomycin.

* * * * *
    (e) * * *
    (3) Swine. It is used in feed as follows:

----------------------------------------------------------------------------------------------------------------
 Oxytetracycline and neomycin sulfate
                amount                                                           Limitations            Sponsors
----------------------------------------------------------------------------------------------------------------
(i) To provide 10 mg/lb of body weight  Swine: For treatment of         Feed continuously for 7 to 14     066104
 daily.                                  bacterial enteritis caused by   d; withdraw 5 d before           069254
                                         E. coli and Salmonella          slaughter.
                                         choleraesuis and treatment of
                                         bacterial pneumonia caused by
                                         P. multocida susceptible to
                                         oxytetracycline; treatment
                                         and control of colibacillosis
                                         (bacterial enteritis) caused
                                         by E. coli susceptible to
                                         neomycin.
(ii) To provide 10 mg/lb of body        Breeding swine: For control     Feed continuously for not         066104
 weight daily.                           and treatment of                more than 14 d; withdraw 5 d     069254
                                         leptospirosis (reducing the     before slaughter.
                                         incidence of abortion and
                                         shedding of leptospirae)
                                         caused by Leptospira pomona
                                         susceptible to
                                         oxytetracycline.
----------------------------------------------------------------------------------------------------------------

    (4) Cattle. It is used in feed as follows:

----------------------------------------------------------------------------------------------------------------
 Oxytetracycline and neomycin sulfate
                amount                        Indications for use                Limitations            Sponsors
----------------------------------------------------------------------------------------------------------------
(i) To provide 10 mg/lb of body weight  Calves and beef and             Feed continuously for 7 to 14     066104
 daily.                                  nonlactating dairy cattle:      d; in feed or milk               069254
                                         For treatment of bacterial      replacers. Treatment should
                                         enteritis caused by E. coli     continue 24 to 48 hours
                                         and bacterial pneumonia         beyond remission of disease
                                         (shipping fever complex)        symptoms. A withdrawal
                                         caused by P. multocida          period has not been
                                         susceptible to                  established for use in
                                         oxytetracycline; treatment      preruminating calves. Do not
                                         and control of colibacillosis   use in calves to be
                                         (bacterial enteritis) caused    processed for veal. A milk
                                         by E. coli susceptible to       discard time has not been
                                         neomycin.                       established for use in
                                                                         lactating dairy cattle. Do
                                                                         not use in female dairy
                                                                         cattle 20 months of age or
                                                                         older. Withdraw 5 d before
                                                                         slaughter.
(ii) To provide 10 mg/lb of body        Calves (up to 250 lb): For      Feed continuously for 7 to 14     066104
 weight daily.                           treatment of bacterial          d; in milk replacers or          069254
                                         enteritis caused by E. coli     starter feed. Treatment
                                         susceptible to                  should continue 24 to 48
                                         oxytetracycline; treatment      hours beyond remission of
                                         and control of colibacillosis   disease symptoms. A
                                         (bacterial enteritis) caused    withdrawal period has not
                                         by E. coli susceptible to       been established for use in
                                         neomycin.                       preruminating calves. Do not
                                                                         use in calves to be
                                                                         processed for veal. A milk
                                                                         discard time has not been
                                                                         established for use in
                                                                         lactating dairy cattle. Do
                                                                         not use in female dairy
                                                                         cattle 20 months of age or
                                                                         older. Withdraw 5 d before
                                                                         slaughter.
(iii) To provide 75 mg/head/day.......  Growing cattle (over 400 lb):   Feed continuously............     066104
                                         For the reduction of the                                         069254
                                         incidence of liver abscesses.
(iv) To provide 0.5 to 2.0 g/head/ day  Cattle: For prevention and      Feed 3 to 5 d before and          066104
                                         treatment of the early stages   after arrival in feedlots. A     069254
                                         of shipping fever complex.      withdrawal period has not
                                                                         been established for use in
                                                                         preruminating calves. Do not
                                                                         use in calves to be
                                                                         processed for veal. A milk
                                                                         discard time has not been
                                                                         established for use in
                                                                         lactating dairy cattle. Do
                                                                         not use in female dairy
                                                                         cattle 20 months of age or
                                                                         older.
----------------------------------------------------------------------------------------------------------------

    (5) S. It is used in feed as follows:

----------------------------------------------------------------------------------------------------------------
 Oxytetracycline and neomycin sulfate
                amount                        Indications for use                Limitations            Sponsors
----------------------------------------------------------------------------------------------------------------
(i) To provide 10 mg/lb of body weight  Sheep: For treatment of         Feed continuously for 7 to 14     66104,
 daily.                                  bacterial enteritis caused by   d. If symptoms persist after     069254
                                         E. coli and bacterial           using for 2 or 3 days,
                                         pneumonia caused by P.          consult a veterinarian.
                                         multocida susceptible to        Treatment should continue 24
                                         oxytetracycline; treatment      to 48 hours beyond remission
                                         and control of colibacillosis   of disease symptoms.
                                         (bacterial enteritis) caused    Withdraw 5 d before
                                         by E. coli susceptible to       slaughter.
                                         neomycin.
(ii) [Reserved].......................
----------------------------------------------------------------------------------------------------------------

0
24. In Sec.  558.575, revise paragraphs (e)(3)(iv) and (v) to read as
follows:

Sec.  558.575  Sulfadimethoxine and ormetoprim.

* * * * *
    (e) * * *
    (3) * * *

----------------------------------------------------------------------------------------------------------------
  Sulfadimethoxine and ormetoprim amount        Indications for use               Limitations           Sponsors
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
(iv) 630 to 3780 g/ton sulfadimethoxine    Salmonids: For the control    Administer for 5 consecutive     015331
 and 126 to 756 g/ton ormetoprim to         of furunculosis in            days. Withdraw 42 days
 provide 50 milligrams (mg) of active       salmonids (trout and          before release as stocker
 ingredients per kilogram of body per day.  salmon) caused by Aeromonas   fish or slaughter.
                                            salmonicida strains
                                            susceptible to
                                            sulfadimethoxine and
                                            ormetoprim combination.
(v) 630 to 3780 g/ton sulfadimethoxine     Catfish: For control of       Administer for 5 consecutive     015331
 and 126 to 756 g/ton ormetoprim to         enteric septicemia of         days. Withdraw 3 days
 provide 50 mg of active ingredients per    catfish caused by             before slaughter or release
 kilogram of body per day.                  Edwardsiella ictaluri         as stocker fish.
                                            strains susceptible to
                                            sulfadimethoxine and
                                            ormetoprim combination.
----------------------------------------------------------------------------------------------------------------

    Dated: November 1, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
 [FR Doc. 2022-24106 Filed 12-13-22; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 86, Number 212 (Friday, November 5, 2021)]
[Notices]
[Page 61279]
[FR Doc No: 2021-24234]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-1996-D-0405]

Compliance Policy Guide Sec. 110.100; Withdrawal of Guidance

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; withdrawal.

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

SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the withdrawal of Compliance Policy Guide Sec. 110.100,
``Certification for Exports'' (CPG Sec. 110.100), which FDA issued in
1980. We are taking this action because CPG Sec. 110.100 contains
information that is either duplicative of other information we have
published or no longer reflects the Agency's current thinking.

DATES: The withdrawal is effective November 5, 2021.

FOR FURTHER INFORMATION CONTACT: Tiffany Kelley, Office of Regulatory
Affairs, Food and Drug Administration, 10903 New Hampshire Ave., Silver
Spring, MD 20993-0002,<PHONE_NUMBER>, [email protected].

SUPPLEMENTARY INFORMATION: FDA originally issued CPG Sec. 110.100 on
October 1, 1980, in the Agency's Manual of Compliance Policy Guides.
The CPG was revised periodically but has not been revised since April
14, 2000.
    Since FDA last revised CPG Sec. 110.100, the Agency issued separate
guidance for industry on FDA export certification in 2004. FDA revised
that guidance in 2005, 2019, and, most recently, in August 2021. The
August 2021 version of the guidance for industry, entitled ``FDA Export
Certification,'' provides the Agency's current guidance regarding FDA
issuance of export certification. Persons with access to the internet
may obtain the guidance at https://www.fda.gov/regulatory-information/search-fda-guidance-documents. Although this guidance originally
complemented the content in CPG Sec. 110.100, changes in the document
over time have increasingly resulted in CPG Sec. 110.100 containing
duplicative and outdated information. Thus, FDA is withdrawing CPG Sec.
110.100 in its entirety.

    Dated: November 1, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-24234 Filed 11-4-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 88, Number 27 (Thursday, February 9, 2023)]
[Notices]
[Pages 8417-8418]
[FR Doc No: 2023-02748]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP22-493-000]

Tennessee Gas Pipeline Company, LLC; Notice of Availability of
the Draft Environmental Impact Statement for the Proposed Cumberland
Project

    The staff of the Federal Energy Regulatory Commission (FERC or
Commission) has prepared a draft Environmental Impact Statement (EIS)
for the Cumberland Project (Project), proposed by Tennessee Gas
Pipeline Company, LLC (Tennessee) in the above-referenced docket.
Tennessee requests a Certificate of Public Convenience and Necessity to
construct, operate, and maintain certain natural gas transmission
pipeline and facilities in Dickson, Houston, and Stewart Counties,
Tennessee. The Project purpose is to provide up to 245,040 dekatherms
per day of new firm transportation service to the Tennessee Valley
Authority's (TVA) Cumberland Natural Gas Combined Cycle Power Plant.
    The draft EIS assesses the potential environmental effects of the
construction and operation of the Project in accordance with the
requirements of the National Environmental Policy Act (NEPA). The FERC
staff concludes that approval of the proposed Project, with the
mitigation measures recommended in the EIS, would result in some
adverse environmental impacts. Most of these impacts would be temporary
and occur during construction (e.g., impacts on wetlands, land use,
traffic, and noise). Except for climate change impacts that are not
characterized in the EIS as significant or insignificant, Commission
staff conclude that project effects would not be significant. As part
of the analysis, Commission staff developed specific mitigation
measures (included in the draft EIS as recommendations). Staff
recommend that these mitigation measures be attached as conditions to
any authorization issued by the Commission.
    The U.S. Army Corps of Engineers and the U.S. Environmental
Protection Agency participated as cooperating agencies in the
preparation of the EIS. Cooperating agencies have jurisdiction by law
or special expertise with respect to resources potentially affected by
a proposal and participate in the NEPA analysis. Although both agencies
provided input to the conclusions and recommendations presented in the
draft EIS, each agency may present its own conclusions and
recommendations in any applicable Records of Decision or other
documentation for the Project.
    The draft EIS addresses the potential environmental effects of the
construction and operation of the following Project facilities, all in
the state of Tennessee:
     Cumberland Pipeline: Construction of approximately 32
miles of new 30-inch-diameter natural gas pipeline, which would connect
at Tennessee's existing Line 100-3 and Line 100-4. The Cumberland
Pipeline would be located in Dickson, Houston, and Stewart Counties.
     Pressure Regulation Station: Construction of two new bi-
directional back pressure regulation facilities on Line 100-3 and Line
100-4, at milepost 0.0 of the proposed new Cumberland Pipeline in
Dickson County.
     Cumberland Meter Station: Construction of a new meter
station at the terminus of the Cumberland Pipeline, located within
TVA's property in Stewart County.
     Launcher and Receiver: Construction of in-line inspection
traps, for in-line inspection tools at each end of the Cumberland
Pipeline.
     Mainline Valves: Construction of three new mainline
valves. One would be installed at an intermediate location along the
Cumberland Pipeline, and the remaining two would be on Tennessee's Line
100-3 and Line 100-4 within the new Pressure Regulation Station.
    The Commission mailed a copy of the Notice of Availability of the
Draft Environmental Impact Statement for the Proposed Cumberland
Project to federal, state, and local government representatives and
agencies; elected officials; environmental and public interest groups;
Native American Tribes; potentially affected landowners and other
interested individuals and groups; and newspapers and libraries in the
Project area. The draft EIS is only available in electronic format. It
may be viewed and downloaded from the FERC website (https://ferc.gov/),
on the natural gas environmental documents page (https://www.ferc.gov/industries-data/natural-gas/environmental-overview/environmental-documents-2023). In addition, the draft EIS may be accessed using the
eLibrary link on the FERC website. Click on the eLibrary link (https://elibrary.ferc.gov/eLibrary/search) select ``General Search'' and enter
the docket number in the ``Docket Number'' field, excluding the last
three digits (i.e., CP22-493). Be sure you have selected an appropriate
date range. For assistance, please contact FERC Online Support at
[email protected] or toll free at<PHONE_NUMBER>, or for TTY,
contact<PHONE_NUMBER>.
    The draft EIS is not a decision document. It presents Commission
staff's independent analysis of the environmental issues for the
Commission to consider when addressing the merits of all issues in this
proceeding. Any person wishing to comment on the draft EIS may do so.
Your comments should focus on the draft EIS' disclosure and discussion
of potential environmental effects, measures to avoid or lessen
environmental impacts, and the completeness of the submitted
alternatives, information and analyses. To ensure consideration of your
comments on the proposal in the final EIS, it is important that the
Commission receive your comments on or before 5:00 p.m. Eastern Time on
March 27, 2023.
    For your convenience, there are four methods you can use to submit
your comments to the Commission. The Commission will provide equal
consideration to all comments received, whether filed in written form
or provided orally. The Commission encourages electronic filing of
comments and has staff available to assist you at<PHONE_NUMBER> or
[email protected]. Please carefully follow these instructions
so that your comments are properly recorded.
    (1) You can file your comments electronically using the eComment
feature on the Commission's website (https://ferc.gov/) under the link
to FERC Online. This is an easy method for submitting brief, text-only
comments on a project;
    (2) You can file your comments electronically by using the eFiling
feature on the Commission's website (https://ferc.gov/) under the link
to FERC Online. With eFiling, you can provide comments in a variety of
formats by attaching them as a file with your submission. New eFiling
users must first create an account by clicking on ``eRegister.'' If you
are filing a comment on a particular project, please select ``Comment
on a Filing'' as the filing type; or
    (3) You can file a paper copy of your comments by mailing them to
the Commission. Be sure to reference the Project docket number (CP22-
493-000) on your letter. Submissions sent via the U.S. Postal Service
must be addressed to: Kimberly D. Bose, Secretary, Federal Energy
Regulatory Commission, 888 First Street NE, Room 1A, Washington, DC
20426. Submissions sent via any other carrier must be addressed to:
Kimberly D. Bose, Secretary, Federal

Energy Regulatory Commission, 12225 Wilkins Avenue, Rockville, MD
20852.
    (4) In lieu of sending written or electronic comments, the
Commission invites you to attend one of the public comment sessions its
staff will conduct to receive comments on the draft EIS, scheduled as
follows:

------------------------------------------------------------------------
           Date                     Time                 Location
------------------------------------------------------------------------
2/21/2023.................  5:00-8:00 p.m.       Events on Main, 105 S
                             Central Standard     Main Street, Dickson,
                             Time.                TN 37055, (615) 202-
                                                  3453.
2/22/2023.................  5:00-8:00 p.m.       Cumberland City Fire
                             Central Standard     Hall, 121 Main Street,
                             Time.                Cumberland City, TN
                                                  37050,<PHONE_NUMBER>.
------------------------------------------------------------------------

    The primary goal of these comment sessions is to have you identify
the specific environmental issues and concerns regarding the draft EIS.
Individual oral comments will be taken on a one-on-one basis with a
court reporter. This format is designed to receive the maximum amount
of oral comments, in a convenient way during the timeframe allotted.
    Each comment session is scheduled from 5:00 p.m. to 8:00 p.m.
Central Standard Time. You may arrive at any time after 5:00 p.m. There
will not be a formal presentation by Commission staff when the session
opens. If you wish to speak, the Commission staff will hand out numbers
in the order of your arrival. Comments will be taken until 8:00 p.m.
However, if no additional numbers have been handed out and all
individuals who wish to provide comments have had an opportunity to do
so, staff may conclude the session at 7:30 p.m. Please see attachment 1
for additional information on the session format and conduct.\1\
---------------------------------------------------------------------------

    \1\ The attachment referenced in this notice will not appear in
the Federal Register. A copy of the attachment was sent to all those
receiving this notice in the mail and are available at www.ferc.gov
using the link called ``eLibrary'' or from the Commission's Public
Reference Room, 888 First Street NE, Washington, DC 20426, or call
(202) 502-8371.
---------------------------------------------------------------------------

    Your oral comments will be recorded by the court reporter (with
FERC staff or representative present) and become part of the public
record for this proceeding. Transcripts will be publicly available on
FERC's eLibrary system (see page 2 for instructions on using eLibrary).
If a significant number of people are interested in providing oral
comments in the one-on-one settings, a time limit of 5 minutes may be
implemented for each commentor. Although there will not be a formal
presentation, Commission staff will be available throughout the comment
session to answer your questions about the environmental review
process.
    It is important to note that the Commission provides equal
consideration to all comments received, whether filed in written form
or provided at a comment session.
    Any person seeking to become a party to the proceeding must file a
motion to intervene pursuant to Rule 214 of the Commission's Rules of
Practice and Procedures (18 CFR 385.214). Motions to intervene are more
fully described at https://www.ferc.gov/how-intervene. Only intervenors
have the right to seek rehearing or judicial review of the Commission's
decision. The Commission grants affected landowners and others with
environmental concerns intervenor status upon showing good cause by
stating that they have a clear and direct interest in this proceeding
which no other party can adequately represent. Simply filing
environmental comments will not give you intervenor status, but you do
not need intervenor status to have your comments considered.

Questions?

    Additional information about the Project is available from the
Commission's Office of External Affairs, at (866) 208-FERC, or on the
FERC website (www.ferc.gov) using the eLibrary link. The eLibrary link
also provides access to the texts of all formal documents issued by the
Commission, such as orders, notices, and rulemakings.
    In addition, the Commission offers a free service called
eSubscription that allows you to keep track of all formal issuances and
submittals in the specific dockets. This can reduce the amount of time
you spend researching proceedings by automatically providing you with
notification of these filings, document summaries, and direct links to
the documents. Go to https://www.ferc.gov/ferc-online/overview to
register for eSubscription.

    Dated: February 3, 2023.
Kimberly D. Bose,
Secretary.
[FR Doc. 2023-02748 Filed 2-8-23; 8:45 am]
BILLING CODE 6717-01-P