Document ID: FDA-2019-N-0002-0032
Agency: fda
Document Type: Rule
Title: New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsors’ Name and Addresses
Posted Date: 2020-04-01T04:00Z

[Federal Register Volume 85, Number 63 (Wednesday, April 1, 2020)]
[Rules and Regulations]
[Pages 18114-18125]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-06688]

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

Food and Drug Administration

21 CFR Parts 500, 510, 520, 522, 524, 526, 556, and 558

[Docket No. FDA-2019-N-0002]

New Animal Drugs; Approval of New Animal Drug Applications; 
Withdrawal of Approval of New Animal Drug Applications; Change of 
Sponsor; Change of Sponsors' Name and Addresses

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendments.

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

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) and abbreviated new animal drug 
applications (ANADAs) during October, November, and December 2019. FDA 
is informing the public of the availability

[[Page 18115]]

of summaries of the basis of approval and of environmental review 
documents, where applicable. The animal drug regulations are also being 
amended to make technical amendments to improve the accuracy of the 
regulations.

DATES: This rule is effective March 30, 2020.

FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for 
Veterinary Medicine (HFV-6), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-402-5689, 
george.haibel@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Approval Actions

    FDA is amending the animal drug regulations to reflect approval 
actions for NADAs and ANADAs during October, November, and December 
2019, 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. 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.

                        Table 1--Original and Supplemental NADAs and ANADAs Approved During October, November, and December 2019
--------------------------------------------------------------------------------------------------------------------------------------------------------
    Approval date       File No.         Sponsor             Product name            Species            Effect of the action         Public  documents
--------------------------------------------------------------------------------------------------------------------------------------------------------
October 11, 2019.....    200-652  Huvepharma EOOD, 5th   Monensin and          Cattle............  Original approval for use of    FOI Summary.
                                   Floor, 3A Nikolay      decoquinate Type B                        MONOVET 90 (monensin Type A
                                   Haytov Str., 1113      and Type C                                medicated article) with
                                   Sophia, Bulgaria.      medicated feeds.                          DECCOX (decoquinate) Type A
                                                                                                    medicated articles in the
                                                                                                    manufacture of Type B and
                                                                                                    Type C medicated feeds as a
                                                                                                    generic copy of NADA 141-148
October 11, 2019.....    200-653  Do...................  Monensin, tylosin     Cattle............  Original approval for use of    FOI Summary.
                                                          phosphate, and                            MONOVET 90 (monensin Type A
                                                          decoquinate Type B                        medicated article) with
                                                          and Type C                                TYLOVET (tylosin phosphate)
                                                          medicated feeds.                          and DECCOX (decoquinate) Type
                                                                                                    A medicated articles in the
                                                                                                    manufacture of Type B and
                                                                                                    Type C medicated feeds as a
                                                                                                    generic copy of NADA 141-149
October 11, 2019.....    200-654  Do...................  Monensin and          Cattle............  Original approval for use of    FOI Summary.
                                                          tilmicosin                                MONOVET 90 (monensin Type A
                                                          phosphate Type B                          medicated article) with
                                                          and Type C                                TILMOVET (tilmicosin
                                                          medicated feeds.                          phosphate) Type A medicated
                                                                                                    article in the manufacture of
                                                                                                    Type B and Type C medicated
                                                                                                    feeds as a generic copy of
                                                                                                    NADA 141-343
October 11, 2019.....    200-655  Do...................  Monensin and          Cattle............  Original approval for use of    FOI Summary.
                                                          tilmicosin                                MONOVET 90 (monensin Type A
                                                          phosphate Type B                          medicated article) with
                                                          and Type C                                PULMOTIL (tilmicosin
                                                          medicated feeds.                          phosphate) Type A medicated
                                                                                                    article in the manufacture of
                                                                                                    Type B and Type C medicated
                                                                                                    feeds as a generic copy of
                                                                                                    NADA 141-343
October 11, 2019.....    200-656  Do...................  Monensin, tylosin     Cattle............  Original approval for use of    FOI Summary.
                                                          phosphate, and                            MONOVET 90 (monensin Type A
                                                          decoquinate Type B                        medicated article) with TYLAN
                                                          and Type C                                (tylosin phosphate) and
                                                          medicated feeds.                          DECCOX (decoquinate) Type A
                                                                                                    medicated articles in the
                                                                                                    manufacture of Type B and
                                                                                                    Type C medicated feeds as a
                                                                                                    generic copy of NADA 141-149
October 11, 2019.....    200-658  Do...................  Monensin and          Cattle............  Original approval for use of    FOI Summary.
                                                          melengestrol                              MONOVET 90 (monensin Type A
                                                          acetate Type C                            medicated article) with MGA
                                                          medicated feeds.                          (melengestrol acetate Type A
                                                                                                    medicated article) in the
                                                                                                    manufacture of Type C
                                                                                                    medicated feeds as a generic
                                                                                                    copy of NADA 125-476
October 11, 2019.....    200-659  Do...................  Monensin,             Cattle............  Original approval for use of    FOI Summary.
                                                          ractopamine                               MONOVET 90 (monensin Type A
                                                          hydrochloride, and                        medicated article) with
                                                          melengestrol                              ACTOGAIN (ractopamine
                                                          acetate Type C                            hydrochloride Type A
                                                          medicated feeds.                          medicated article) and MGA
                                                                                                    (melengestrol acetate Type A
                                                                                                    medicated articles) in the
                                                                                                    manufacture of Type C
                                                                                                    medicated feeds as a generic
                                                                                                    copy of NADA 141-234
October 11, 2019.....    200-660  Do...................  Monensin, tylosin     Cattle............  Original approval for use of    FOI Summary.
                                                          phosphate, and                            MONOVET 90 (monensin Type A
                                                          melengestrol                              medicated article) with
                                                          acetate Type C                            TYLOVET (tylosin phosphate)
                                                          medicated feeds.                          Type A medicated article, and
                                                                                                    MGA (melengestrol acetate
                                                                                                    Type A medicated article) in
                                                                                                    the manufacture of Type C
                                                                                                    medicated feeds as a generic
                                                                                                    copy of NADA 138-870

[[Page 18116]]

 
October 11, 2019.....    200-661  Do...................  Monensin, tylosin     Cattle............  Original approval for use of    FOI Summary.
                                                          phosphate, and                            MONOVET 90 (monensin Type A
                                                          melengestrol                              medicated article) with TYLAN
                                                          acetate Type C                            (tylosin phosphate) Type A
                                                          medicated feeds.                          medicated article, and MGA
                                                                                                    (melengestrol acetate Type A
                                                                                                    medicated article) in the
                                                                                                    manufacture of Type C
                                                                                                    medicated feeds as a generic
                                                                                                    copy of NADA 138-870
October 11, 2019.....    200-662  Do...................  Monensin and          Cattle............  Original approval for use of    FOI Summary.
                                                          ractopamine                               MONOVET 90 (monensin Type A
                                                          hydrochloride Type                        medicated article) with
                                                          B and Type C                              ACTOGAIN (ractopamine
                                                          medicated feeds.                          hydrochloride Type A
                                                                                                    medicated article) in the
                                                                                                    manufacture of Type B and
                                                                                                    Type C medicated feeds as a
                                                                                                    generic copy of NADA 141-225
October 29, 2019.....    200-635  Mizner Bioscience      Clomipramine          Dogs..............  Original approval as a generic  FOI Summary.
                                   LLC, 225 NE Mizner     Hydrochloride                             copy of NADA 141-120
                                   Blvd., Suite 760,      Tablets.
                                   Boca Raton, FL 33432.
November 14, 2019....    141-518  Intervet, Inc., 2      BRAVECTO PLUS         Cats..............  Original approval for the       FOI Summary.
                                   Giralda Farms,         (fluralaner and                           prevention of heartworm
                                   Madison, NJ 07940.     moxidectin topical                        disease and for the treatment
                                                          solution) Solution.                       of infections with intestinal
                                                                                                    roundworm and hookworm; kills
                                                                                                    adult fleas and is indicated
                                                                                                    for the treatment and
                                                                                                    prevention of flea
                                                                                                    infestations, and the
                                                                                                    treatment and control of tick
                                                                                                    infestations for 2 months in
                                                                                                    cats and kittens
November 20, 2019....    200-663  Norbrook Laboratories  SELARID (selamectin)  Dogs and cats.....  Original approval as a generic  FOI Summary.
                                   Ltd., Station Works,   Topical Solution.                         copy of NADA 141-152
                                   County Down, Newry,
                                   BT35 6JP, UK.
November 25, 2019....    141-513  Kindred Biosciences,   ZIMETA (dipyrone      Horses............  Original approval for control   FOI Summary.
                                   Inc., 1555 Bayshore    injection).                               of pyrexia in horses
                                   Hwy., Suite 200,
                                   Burlingame, CA 94010.
December 9, 2019.....    141-528  Elanco US Inc., 2500   CREDELIO CAT          Cats..............  Original approval for killing   FOI Summary.
                                   Innovation Way,        (lotilaner)                               adult fleas, and for the
                                   Greenfield, IN 46140.  Chewable Tablets.                         treatment and prevention of
                                                                                                    flea infestations for 1 month
                                                                                                    in cats and kittens
December 9, 2019.....    200-546  Bimeda Animal Health   BIMAGARD 12.5%        Swine.............  Original approval as a generic  FOI Summary.
                                   Ltd., 1B The Herbert   (tiamulin hydrogen                        copy of NADA 140-916
                                   Building, The Park,    fumarate) Liquid
                                   Carrickmines,          Concentrate for
                                   Dublin, 18, EI.        Swine.
December 19, 2019....    200-615  Vetoquinol USA, Inc.,  IMOXI (imidacloprid   Dogs..............  Original approval as a generic  FOI Summary.
                                   4250 N. Sylvania       and moxidectin)                           copy of NADA 141-251
                                   Ave., Fort Worth, TX   Topical Solution
                                   76137.                 for Dogs.
December 30, 2019....    111-636  Zoetis Inc., 333       LINCOMIX (lincomycin  Honeybees.........  Supplemental approval of a      FOI Summary.
                                   Portage St.,           hydrochloride)                            tolerance for residues of
                                   Kalamazoo, MI 49007.   Soluble Powder.                           lincomycin in honey
December 30, 2019....    008-862  Do...................  TERRAMYCIN            Honeybees.........  Supplemental approval of a      FOI Summary.
                                                          (oxytetracycline                          tolerance for residues of
                                                          hydrochloride)                            oxytetracycline in honey
                                                          Soluble Powder.
December 30, 2019....    013-076  Elanco US Inc. 2500    TYLAN (tylosin        Honeybees.........  Supplemental approval of a      FOI Summary.
                                   Innovation Way,        tartrate) Soluble.                        tolerance for residues of
                                   Greenfield, IN 46140.                                            tylosin in honey
--------------------------------------------------------------------------------------------------------------------------------------------------------

II. Withdrawals of Approval

    Norbrook Laboratories, Ltd., Station Works, Newry BT35 6JP, 
Northern Ireland, has requested that FDA withdraw approval of the NADAs 
listed in the following table because the products are no longer 
manufactured or marketed:

------------------------------------------------------------------------
   File No.                Product name               21 CFR  section
------------------------------------------------------------------------
055-036.......  PRINCILLIN (ampicillin             520.90c.
                 trihydrate) Capsules.
055-050.......  PRINCILLIN (ampicillin             520.90e.
                 trihydrate) Soluble Powder.
055-056.......  PRINCILLIN (ampicillin             520.90f.
                 trihydrate) Bolus.
055-061.......  PRINCILLIN ``125'' For Oral        520.90d.
                 Suspension.
055-068.......  BOVICLOX (cloxacillin benzathine)  526.464b.
065-013.......  Dihydrostreptomycin                522.650.
                 (dihydrostreptomycin sulfate).
065-493.......  JETPEN (penicillin G benzathine    522.1696a.
                 and penicillin G procaine)
                 Aqueous Suspension.
065-500.......  TANDEM PEN (penicillin G           522.1696b.
                 procaine).
------------------------------------------------------------------------

[[Page 18117]]

    Elsewhere in this issue of the Federal Register, FDA gave notice 
that approval of NADAs 055-036, 055-050, 055-056, 055-061, 055-068, 
065-013, 065-493, and 065-500, and all supplements and amendments 
thereto, is withdrawn, effective March 30, 2020. As provided in the 
regulatory text of this document, the animal drug regulations are 
amended to reflect these actions.

III. Changes of Sponsor

    Cooperative Research Farms, Box 69, Charlotteville, NY 12036, has 
informed FDA that it has transferred ownership of, and all rights and 
interest in, approved NADA 119-253 for Cattle Block M (monensin) a 
free-choice Type C medicated cattle feed to Wildcat Feeds, 215 NE 
Strait Ave., Topeka, KS 66616. Following this change of sponsorship, 
Cooperative Research Farms is no longer the sponsor of an approved 
application.
    Dechra, Ltd., Snaygill Industrial Estate, Keighley Rd., Skipton, 
North Yorkshire, BD23 2RW, United Kingdom, has informed FDA that it has 
transferred ownership of, and all rights and interest in, approved 
ANADA 200-273 for VETRO-GEN Veterinary Ophthalmic Ointment to Putney, 
Inc., One Monument Sq., suite 400, Portland, ME 04101.
    Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str., 1113 Sofia, 
Bulgaria, has informed FDA that it has transferred ownership of, and 
all rights and interest in, approved NADA 141-472 for virginiamycin and 
diclazuril Type C medicated feed to Elanco US Inc., 2500 Innovation 
Way, Greenfield, IN 46140.
    Accordingly, we are amending the regulations to reflect these 
changes.

IV. Change of Sponsors' Name and Addresses

    Putney, Inc., One Monument Sq., suite 400, Portland, ME 04101, has 
informed FDA that it has changed its name and address to Dechra 
Veterinary Products LLC, 7015 College Blvd., suite 525, Overland Park, 
KS 66211. In addition, Virbac AH, Inc., 3200 Meacham Blvd., Ft. Worth, 
TX 76137 has informed FDA that it has changed its address to PO Box 
162059, Fort Worth, TX 76161. Accordingly, we are amending Sec.  
510.600(c) (21 CFR 510.600(c)) to reflect these changes.

V. Technical Amendments

    FDA is making the following amendments to improve the readability 
and accuracy of the animal drug regulations:
     The contact information in 21 CFR 500.1410, which provides 
for the incorporation by reference of the residue assay method for n-
methyl-2-pyrrolidone, is being updated.
     We are removing entries for ``Strategic Veterinary 
Pharmaceuticals, Inc.'' from the lists of sponsors of approved 
applications in Sec.  510.600(c) and the drug labeler code for KC 
Pharmacal from 21 CFR 520.260.
     The indications for use of oxytetracycline soluble powder 
in honey bees at 21 CFR 520.1660d are amended to reflect current 
labeling.
     The single section for euthanasia injectable solutions at 
21 CFR 522.900 is being removed and separate sections for the active 
pharmaceutical ingredients are added at 21 CFR 522.1697 and 522.2092.
     The section heading in 21 CFR 524.1742 for ``N-
(Mercaptomethyl) phthalimide S-(O,O-dimethyl phosphorodithioate) 
emulsifiable liquid'' is amended to read ``Phosmet emulsifiable 
liquid''.
     The entries in 21 CFR parts 556 and 558 for coumaphos for 
which approval of the last approved application was withdrawn in 2018 
(83 FR 48940, September 28, 2018) are being removed.
     The entries in part 556 (21 CFR part 556) are being 
removed for tolerances of residues of erythromycin in swine tissues, of 
virginiamycin in turkey tissues, and of new animal drugs for which 
approval of their applications has been withdrawn.
     Cross-references to related approved uses of new animal 
drugs in part 556 and to related tolerances for drugs approved for use 
in food-producing animals in 21 CFR parts 520, 522, 524, and 558 are 
being corrected.
     A redundant cross-reference for related tolerances in 21 
CFR 558.355 for use of monensin in medicated feeds is being removed and 
reserved.
     The acceptable daily intake of total residues of 
ivermectin and tolerances for residues of ivermectin in cattle liver 
and muscle in Sec.  556.344 are being corrected.
     The acceptable daily intake of total residues of 
tildipirosin in Sec.  556.733 is being corrected.
     The regulations in 21 CFR 520.2260b for sulfamethazine 
sustained-release boluses and in 21 CFR 522.1662a for oxytetracycline 
hydrochloride injection are being reformatted to present the tolerance 
cross-reference in a consistent location.
     Typographical errors are being corrected wherever they 
have been found.

VI. 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 500

    Animal drugs, Animal feeds, Cancer, Incorporation by reference, 
Labeling, Packaging and containers, Polychlorinated biphenyls (PCBs).

21 CFR Parts 520, 522, 524, and 526

    Animal drugs.

21 CFR Part 556

    Animal drugs, Food.

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 
500, 510, 520, 522, 524, 526, 556, and 558 are amended as follows:

PART 500--GENERAL

0
1. The authority citation for part 500 continues to read as follows:

    Authority: 21 U.S.C. 321, 331, 342, 343, 348, 351, 352, 353, 
360b, 371, 379e.

0
2. In Sec.  500.1410, revise paragraph (a) to read as follows:

Sec.  500.1410  N-methyl-2-pyrrolidone.

    (a) Standard for residues. No residues of n-methyl-2-pyrrolidone 
may be found in the uncooked edible tissues of cattle as determined by 
a method entitled ``Method of Analysis: N-methyl-2-

[[Page 18118]]

pyrrolidone,'' September 26, 2011, Center for Veterinary Medicine, Food 
and Drug Administration, which is incorporated by reference with the 
approval of the Director of the Federal Register under 5 U.S.C. 522(a) 
and 1 CFR part 51. To obtain a copy of the analytical method, please 
submit a Freedom of Information request to: https://www.accessdata.fda.gov/scripts/foi/FOIRequest/requestinfo.cfm; or go 
to: https://www.fda.gov/about-fda/center-veterinary-medicine/cvm-foia-electronic-reading-room. You may inspect a copy at the office of the 
Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, Rm. 1061, Rockville, MD 20852, 301-827-6860, between 9 
a.m. and 4 p.m., Monday through Friday or at the National Archives and 
Records Administration (NARA). For information on the availability of 
this material at NARA, email fedreg.legal@nara.gov, or go to: 
www.archives.gov/federal-register/cfr/ibr-locations.html.
* * * * *

PART 510--NEW ANIMAL DRUGS

0
3. 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
4. In Sec.  510.600:
0
a. In the table in paragraph (c)(1):
0
i. Remove the entry for ``Cooperative Research Farms'';
0
ii. Add entries for ``Dechra Veterinary Products LLC'' and ``Mizner 
Bioscience LLC'' in alphabetical order;
0
iii. Remove the entries for ``Putney, Inc.'' and ``Strategic Veterinary 
Pharmaceuticals, Inc.'';
0
iv. Revise the entry for ``Virbac AH, Inc.''; and
0
v. Add an entry for ``Wildcat Feeds'' in alphabetical order; and
0
b. In the table in paragraph (c)(2):
0
i. Revise the entry for ``026637'';
0
ii. Remove the entry for ``051267'';
0
iii. Revise the entry for ``051311'';
0
iv. Remove the entry for ``054628''; and
0
v. Add entries for ``086039'' and ``086113'' in numerical order.
    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
------------------------------------------------------------------------
 
                              * * * * * * *
Dechra Veterinary Products LLC, 7015 College Blvd.,               026637
 Suite 525, Overland Park, KS 66211.....................
 
                              * * * * * * *
Mizner Bioscience LLC, 225 NE Mizner Blvd., Suite 760,            086039
 Boca Raton, FL 33432...................................
 
                              * * * * * * *
Virbac AH, Inc., PO Box 162059, Fort Worth, TX 76161....          051311
 
                              * * * * * * *
Wildcat Feeds, 215 NE Strait Ave., Topeka, KS 66616.....          086113
 
                              * * * * * * *
------------------------------------------------------------------------

    (2) * * *

----------------------------------------------------------------------------------------------------------------
           Drug labeler code                                      Firm name and address
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
026637.................................  Dechra Veterinary Products LLC, 7015 College Blvd., Suite 525, Overland
                                          Park, KS 66211.
 
                                                  * * * * * * *
051311.................................  Virbac AH, Inc., PO Box 162059, Fort Worth, TX 76161.
 
                                                  * * * * * * *
086039.................................  Mizner Bioscience LLC, 225 NE Mizner Blvd., Suite 760, Boca Raton, FL
                                          33432.
 
                                                  * * * * * * *
086113.................................  Wildcat Feeds, 215 NE Strait Ave., Topeka, KS 66616.
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

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.  520.88c  [Amended]

0
6. In Sec.  520.88c(c), remove ``Sec.  556.510'' and in its place add 
``Sec.  556.38''.

Sec.  Sec.  520.90b and 520.90c  [Redesignated as Sec. Sec.  520.90a 
and 520.90b]

0
7. Redesignate Sec. Sec.  520.90b and 520.90c as Sec. Sec.  520.90a and 
520.90b.

Sec.  Sec.  520.90d and 520.90e  [Removed]

0
8. Remove Sec. Sec.  520.90d and 520.90e.

Sec.  520.90f  [Redesignated as Sec.  520.90c and Amended]

0
9. Redesignate Sec.  520.90f as Sec.  520.90c and in newly redesignated 
Sec.  520.90c, revise paragraphs (b) and (d) to read as follows:

[[Page 18119]]

Sec.  520.90c  Ampicillin boluses.

* * * * *
    (b) Sponsor. See No. 054771 in Sec.  510.600(c) of this chapter.
* * * * *
    (d) Conditions of use in nonruminating calves--(1) Amount. 5 
milligrams per pound of body weight twice daily not to exceed 4 days.
    (2) Indications for use. Oral treatment of bacterial enteritis 
(colibacillosis) caused by E. coli.
    (3) Limitations. Treated calves must not be slaughtered for food 
during treatment and for 7 days after the last treatment. Federal law 
restricts this drug to use by or on the order of a licensed 
veterinarian.

Sec.  520.260  [Amended]

0
10. In Sec.  520.260(b)(2), remove ``No. 038782 for 884 or 1,768 
milligram or 4.42 gram capsules;''.

Sec.  520.455  [Amended]

0
11. In Sec.  520.455(b), remove ``No. 058198'' and in its place add 
``Nos. 058198 and 086039''.

Sec.  Sec.  520.903d and 520.903e  [Redesignated as Sec. Sec.  520.903c 
and 520.903d]

0
12. Redesignate Sec. Sec.  520.903d and 520.903e as Sec. Sec.  520.903c 
and 520.903d.

Sec.  520.1263c  [Redesignated as Sec.  520.1263b]

0
13. Redesignate Sec.  520.1263c as Sec.  520.1263b.

0
14. Revise Sec.  520.1286 to read as follows:

Sec.  520.1286  Lotilaner.

    (a) Specifications. Each chewable tablet contains:
    (1) For use in dogs: 56.25, 112.5, 225, 450, or 900 milligrams (mg) 
lotilaner; or
    (2) For use in cats: 12 or 48 mg lotilaner.
    (b) Sponsor. See No. 058198 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Dogs--(i) Amount. Administer orally once 
a month at the recommended minimum dosage of 9 mg/lb (20 mg/kg).
    (ii) Indications for use. Kills adult fleas, and for the treatment 
and prevention of flea infestations (Ctenocephalides felis), and the 
treatment and control of tick infestations (Amblyomma americanum (lone 
star tick), Dermacentor variabilis (American dog tick), Ixodes 
scapularis (black-legged tick), and Rhipicephalus sanguineus (brown dog 
tick)) for 1 month in dogs and puppies 8 weeks of age or older and 
weighing 4.4 pounds or greater.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (2) Cats--(i) Amount. Administer orally once a month at the 
recommended minimum dosage of 2.7 mg/lb (6 mg/kg).
    (ii) Indications for use. Kills adult fleas, and for the treatment 
and prevention of flea infestations (Ctenocephalides felis) for 1 month 
in cats and kittens 8 weeks of age or older and weighing 2 pounds or 
greater.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

0
15. In Sec.  520.1660d, revise paragraph (d)(2)(ii) to read as follows:

Sec.  520.1660d  Oxytetracycline powder.

* * * * *
    (d) * * *
    (2) * * *
    (ii) Indications for use. For control of American foulbrood caused 
by Paenibacillus larvae.
* * * * *

Sec.  Sec.  520.1696b, 520.1696c, and 520.1696d  [Redesignated as 
Sec. Sec.  520.1696a, 520.1696b, and 520.1696c]

0
16. Redesignate Sec. Sec.  520.1696b, 520.1696c, and 520.1696d as 
Sec. Sec.  520.1696a, 520.1696b, and 520.1696c.

Sec.  520.2218  [Amended]

0
17. In Sec.  520.2218(c), remove ``Sec. Sec.  556.670 and 556.685'' and 
in its place add ``Sec. Sec.  556.660, 556.670, and 556.685''.

Sec.  520.2260b  [Amended]

0
18. In Sec.  520.2260b, redesignate paragraphs (a) through (f) and (g) 
as paragraphs (b) through (g) and (a), respectively.

0
19. In Sec.  520.2455, add paragraph (b)(4) to read as follows:

Sec.  520.2455  Tiamulin.

* * * * *
    (b) * * *
    (4) No. 061133 for product described in paragraph (a)(2) of this 
section.
* * * * *

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

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

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

0
21. In Sec.  522.650, revise paragraph (b) to read as follows:

Sec.  522.650  Dihydrostreptomycin sulfate injection.

* * * * *
    (b) Sponsor. See No. 054771 in Sec.  510.600(c) of this chapter.
* * * * *

0
22. Add Sec.  522.728 to read as follows:

Sec.  522.728  Dipyrone.

    (a) Specifications. Each milliliter of solution contains 500 
milligrams (mg) dipyrone.
    (b) Sponsor. See No. 086078 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in horses--(1) Amount. Administer 30 mg per 
kilogram of body weight (13.6 mg per pound) by intravenous injection, 
once or twice daily at a 12-hour interval for up to 3 days.
    (2) Indications for use. For control of pyrexia in horses.
    (3) Limitations. Do not use in horses intended for human 
consumption. Do not use in any food-producing animals, including 
lactating dairy animals. Federal law restricts this drug to use by or 
on the order of a licensed veterinarian.

Sec.  522.900  [Removed]

0
23. Remove Sec.  522.900.

Sec.  522.1367  [Amended]

0
24. In Sec.  522.1367(c)(1)(i), remove ``Sec.  520.1350(c)'' and in its 
place add ``Sec.  520.1367(c)''.

Sec.  522.1662a  [Amended]

0
25. In Sec.  522.1662a:
0
a. Redesignate paragraphs (a) through (e) as paragraphs (b) through 
(f);
0
b. Further redesignate newly redesignated paragraphs (c)(3)(i)(a) 
through (c) and (c)(3)(ii)(a) through (c) as paragraphs (c)(3)(i)(A) 
through (C) and (c)(3)(ii)(A) through (C), respectively;
0
c. Further redesignate newly redesignated paragraphs (e)(3)(i)(a) 
through (c) as paragraphs (e)(3)(i)(A) through (C);
0
d. Further redesignate newly redesignated paragraphs (e)(3)(ii)(a) and 
(b) and paragraphs (e)(3)(ii)(A) and (B);
0
e. Further redesignate newly redesignated paragraphs (e)(3)(iii)(a) 
through (c) as paragraphs (e)(3)(iii)(A) through (C);
0
f. In newly redesignated paragraph (e)(3)(iii)(C), remove ``paragraph 
(d)(3)(iii)(c) of this section'' and in its place add ``this paragraph 
(e)(3)(iii)(C)'';
0
g. Further redesignate newly redesignated paragraphs (f)(3)(i)(a) 
through (c) and (f)(3)(ii)(a) through (c) as paragraphs (f)(3)(i)(A) 
through (C) and (f)(3)(ii)(A) through (C), respectively;
0
h. Redesignate paragraphs (g)(3)(i)(a) through (c) and (g)(3)(ii)(a) 
through (c) as paragraphs (g)(3)(i)(A) through (C)

[[Page 18120]]

and (g)(3)(ii)(A) through (C), respectively; and
0
i. Redesignate paragraph (k) as paragraph (j) and paragraph (l) as 
paragraph (a).

Sec.  522.1696a  [Amended]

0
26. In Sec.  522.1696a(b)(1) and (2) and (d)(2)(iii), remove ``, 
055529,''.

Sec.  522.1696b  [Amended]

0
27. In Sec.  522.1696b:
0
a. In paragraph (b)(1), remove ``016592, 054771, and 055529'' and in 
its place add ``016592 and 054771'';
0
b. Remove paragraphs (d)(2)(i)(A) and (B); and
0
c. In paragraph (d)(2)(iii)(B), remove ``Nos. 000859 and 055529'' and 
in its place add ``No. 016592''.

0
28. Add Sec.  522.1697 to read as follows:

Sec.  522.1697  Pentobarbital and phenytoin.

    (a) Specifications. Each milliliter (mL) of solution contains 390 
milligrams (mg) pentobarbital sodium and 50 mg phenytoin sodium.
    (b) Sponsors. See Nos. 000061, 051311, and 054925 in Sec.  
510.600(c) of this chapter.
    (c) Special considerations. Product labeling shall bear the 
following warning statements: ``ENVIRONMENTAL HAZARD: This product is 
toxic to wildlife. Birds and mammals feeding on treated animals may be 
killed. Euthanized animals must be properly disposed of by deep burial, 
incineration, or other method in compliance with State and local laws, 
to prevent consumption of carcass material by scavenging wildlife.''
    (d) Conditions of use in dogs--(1) Amount. Administer 1 mL per 10 
pounds of body weight as a single, bolus intravenous or intracardiac 
injection.
    (2) Indications for use. For humane, painless, and rapid 
euthanasia.
    (3) Limitations. Do not use in animals intended for food. Federal 
law restricts this drug to use by or on the order of a licensed 
veterinarian.

0
29. Add Sec.  522.2092 to read as follows:

Sec.  522.2092  Secobarbital and dibucaine.

    (a) Specifications. Each milliliter (mL) of solution contains 400 
milligram (mg) secobarbital sodium and 25 mg dibucaine hydrochloride.
    (b) Sponsor. See No. 054771 in Sec.  510.600(c) of this chapter.
    (c) Special considerations. Product labeling shall bear the 
following warning statements: ``ENVIRONMENTAL HAZARD: This product is 
toxic to wildlife. Birds and mammals feeding on treated animals may be 
killed. Euthanized animals must be properly disposed of by deep burial, 
incineration, or other method in compliance with State and local laws, 
to prevent consumption of carcass material by scavenging wildlife.''
    (d) Conditions of use in dogs--(1) Amount. Administer 1 mL per 10 
pounds of body weight as a single, bolus intravenous injection.
    (2) Indications for use. For humane, painless, and rapid 
euthanasia.
    (3) Limitations. Do not use in animals intended for food. Federal 
law restricts this drug to use by or on the order of a licensed 
veterinarian.

PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

0
30. The authority citation for part 524 continues to read as follows:

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

0
31. Add an undesignated center heading before Sec.  524.981 to read as 
follows:
Fluocinolone Topical and Otic Dosage Forms

0
32. Add Sec.  524.1001 to read as follows:

Sec.  524.1001  Furalaner and moxidectin.

    (a) Specifications. Each milliliter of solution contains 280 
milligram (mg) furalaner and 14 mg moxidectin. Each individually 
packaged tube contains either 112.5 mg furalaner and 5.6 mg moxidectin; 
250 mg furalaner and 12.5 mg moxidectin; or 500 mg furalaner and 25 mg 
moxidectin.
    (b) Sponsor. See No. 000061 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. Administer topically as a single 
dose every 2 months to provide a minimum dose of 18.2 mg/lb (40 mg/kg) 
fluralaner and 0.9 mg/lb (2 mg/kg) moxidectin.
    (2) Indications for use. For the prevention of heartworm disease 
caused by Dirofilaria immitis and for the treatment of infections with 
intestinal roundworm (Toxocara cati, 4th stage larvae, immature adults, 
and adults) and hookworm (Ancylostoma tubaeforme, 4th stage larvae, 
immature adults, and adults); kills adult fleas and is indicated for 
the treatment and prevention of flea infestations (Ctenocephalides 
felis) and the treatment and control of tick infestations (Ixodes 
scapularis (black-legged tick) and Dermacentor variabilis (American dog 
tick)) for 2 months in cats and kittens 6 months of age and older and 
weighing 2.6 lb or greater.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

0
33. In Sec.  524.1146, revise paragraphs (a) and (b) to read as 
follows:

Sec.  524.1146  Imidacloprid and moxidectin.

    (a) Specifications. Each milliliter of solution contains:
    (1) 100 milligrams (mg) imidacloprid and 25 mg moxidectin; or
    (2) 100 mg imidacloprid and 10 mg moxidectin.
    (b) Sponsors. See sponsor numbers in Sec.  510.600(c) of this 
chapter as follows:
    (1) Nos. 000859 and 017030 for use of product described in 
paragraph (a)(1) of this section as in paragraph (d)(1) of this 
section.
    (2) No. 000859 for use of product described in paragraph (a)(2) of 
this section as in paragraphs (d)(2) and (3) of this section.
* * * * *

0
34. In Sec.  524.1742:
0
a. Revise the section heading;
0
b. Redesignate paragraphs (c) and (d) as paragraphs (d) and (c), 
respectively;
0
c. Add a heading for the table in newly redesignated paragraph (d)(1) 
introductory text; and
0
d. Further redesignate newly redesignated paragraphs (d)(1)(i)(a) and 
(b) as paragraphs (d)(1)(i)(A) and (B).
    The revision and addition reads as follows:

Sec.  524.1742  Phosmet emulsifiable liquid.

* * * * *
    (d) * * *
    (1) * * *
    Table 1 to Paragraph (d)(1)
* * * * *

Sec.  524.2098  [Amended]

0
35. In Sec.  524.2098(b), remove ``054771'' and in its place add ``Nos. 
054771 and 055529''.

PART 526--INTRAMAMMARY DOSAGE FORM NEW ANIMAL DRUGS

0
36. The authority citation for part 526 continues to read as follows:

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

Sec.  526.464b  [Removed]

0
37. Remove Sec.  526.464b.

Sec.  526.464c  [Redesignated as Sec.  526.464b]

0
38. Redesignate Sec.  526.464c as Sec.  526.464b.

PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD

0
39. The authority citation for part 556 continues to read as follows:

    Authority: 21 U.S.C. 342, 360b, 371.

Sec.  556.40  [Amended]

0
40. In Sec.  556.40(c), remove ``Sec. Sec.  520.90e, 520.90f, 522.90a, 
and 522.90b'' and in

[[Page 18121]]

its place add ``Sec. Sec.  520.90c, 522.90a, and 522.90b''.

Sec.  556.165  [Amended]

0
41. In Sec.  556.165(c), remove ``Sec. Sec.  526.464a, 526.464b, and 
526.464c'' and in its place add ``Sec. Sec.  526.464a and 526.464b''.

Sec.  556.168  [Removed]

0
42. Remove Sec.  556.168.

Sec.  556.230  [Amended]

0
43. In Sec.  556.230, remove paragraph (b)(3).

Sec.  556.304  [Amended]

0
44. In Sec.  556.304(c), remove ``Sec. Sec.  522.1077, 522.1079, and 
522.1081'' and in its place add ``Sec. Sec.  522.1079 and 522.1081''.

Sec.  556.344  [Amended]

0
45. In Sec.  556.344:
0
a. In paragraph (a), remove ``1 [mu]g/kg'' and in its place add ``5 
[mu]g/kg'';
0
b. In paragraph (b)(2)(i), remove ``100 ppb'' and in its place add 
``1.6 ppm''; and
0
c. In paragraph (b)(2)(ii), remove ``10 ppb'' and in its place add 
``650 ppb''.

0
46. In Sec.  556.360, add paragraph (b)(3) and revise paragraph (c) to 
read as follows:

Sec.  556.360  Lincomycin.

* * * * *
    (b) * * *
    (3) Honey. 750 ppb.
    (c) Related conditions of use. See Sec. Sec.  520.1263b, 522.1260, 
and 558.325 of this chapter.

0
47. In Sec.  556.500, add paragraph (b)(6) to read as follows:

Sec.  556.500  Oxytetracycline.

* * * * *
    (b) * * *
    (6) Honey. 750 ppb.
* * * * *

Sec.  556.510  [Amended]

0
48. In Sec.  556.510(c), remove ``520.1696b'' and in its place add 
``520.1696a''.

Sec.  556.660  [Amended]

0
49. In Sec.  556.660(c), remove ``Sec.  558.582'' and in its place add 
``Sec. Sec.  520.2218 and 558.582''.

Sec.  556.670  [Amended]

0
50. In Sec.  556.670, in paragraph (c), remove ``Sec. Sec.  520.2260a, 
520.2260b, 520.2260c, 520.2261a, 520.2261b, 522.2260, 558.140, and 
558.630'' and in its place add ``Sec. Sec.  520.2218, 520.2260a, 
520.2260b, 520.2260c, 520.2261a, 520.2261b, 522.2260, 558.140, and 
558.630''.

Sec.  556.685  [Amended]

0
51. In Sec.  556.685(c), remove ``Sec. Sec.  520.2325a, 520.2325b, and 
558.586'' and in its place add ``Sec. Sec.  520.2218, 520.2325a, 
520.2325b, and 558.586''.

Sec.  556.733  [Amended]

0
52. In Sec.  556.733(a), remove ``10 [mu]g/kg'' and in its place add 
``50 [mu]g/kg''.

0
53. In Sec.  556.746, add paragraph (b)(4) to read as follows:

Sec.  556.746  Tylosin.

* * * * *
    (b) * * *
    (4) Honey. 500 ppb.
* * * * *

Sec.  556.750  [Amended]

0
54. In Sec.  556.750, remove paragraph (b)(4).

0
55. In Sec.  556.765, revise paragraph (b)(1) to read as follows:

Sec.  556.765  Zilpaterol.

* * * * *
    (b) * * *
    (1) Cattle. (i) Liver (target tissue): 12 ppb.
    (ii) Muscle: 10 ppb.
* * * * *

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

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

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

0
57. In Sec.  558.55, add paragraph (d)(5) to read as follows:

Sec.  558.55  Amprolium.

* * * * *
    (d) * * *
    (5) Permitted combinations. Amprolium may also be used in 
combination with:
    (i) Virginiamycin as in Sec.  558.635.
    (ii) [Reserved]

0
58. In Sec.  558.76, revise paragraphs (e)(2)(vii), (viii), and (xi) to 
read as follows:

Sec.  558.76  Bacitracin methylenedisalicylate.

* * * * *
    (e) * * *
    (2) * * *
    (vii) Fenbendazole as in Sec.  558.258.
    (viii) Halofuginone as in Sec.  558.265.
* * * * *
    (xi) Monensin as in Sec.  558.355.
* * * * *

Sec.  558.185  [Removed]

0
59. Remove Sec.  558.185.

0
60. In Sec.  558.195, revise paragraph (e)(2)(ii) to read as follows:

Sec.  558.195  Decoquinate.

* * * * *
    (e) * * *
    (2) * * *

[[Page 18122]]

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                       Combination in  grams/
      Decoquinate in  grams/ton                 ton                 Indications for use               Limitations                     Sponsor
--------------------------------------------------------------------------------------------------------------------------------------------------------
 
                                                                      * * * * * * *
(ii) 12.9 to 90.8...................  Monensin, 5 to 30......  Cattle fed in confinement     Feed continuously as the      016592, 054771.
                                                                for slaughter: For            sole ration to provide 22.7
                                                                prevention of coccidiosis     mg of decoquinate per 100
                                                                caused by Eimeria bovis and   lb of body weight per day
                                                                E. zuernii; and for           and 50 to 360 mg of
                                                                improved feed efficiency.     monensin per head per day.
                                                                                              Feed at least 28 days
                                                                                              during period of exposure
                                                                                              to coccidiosis or when it
                                                                                              is likely to be a hazard.
                                                                                              Do not feed to animals
                                                                                              producing milk for food. Do
                                                                                              not feed to lactating dairy
                                                                                              cattle. Also see paragraph
                                                                                              (d)(1) of this section and
                                                                                              Sec.   558.355(d)(9)(i).
                                                                                              Monensin as provided by No.
                                                                                              016592 or 058198 in Sec.
                                                                                              510.600(c) of this chapter.
 
                                                                      * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------

* * * * *

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

Sec.  558.342  Melengestrol.

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

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                       Combination in  grams/
Melengestrol  acetate in mg/head/day            ton                 Indications for use               Limitations                     Sponsor
--------------------------------------------------------------------------------------------------------------------------------------------------------
 
                                                                      * * * * * * *
(iv) 0.25 to 0.5....................  Monensin, 10 to 40.....  Heifers fed in confinement    Add at the rate of 0.5 to 2   016592, 054771, 058198
                                                                for slaughter: For            lb/head/day a medicated
                                                                increased rate of weight      feed (liquid or dry)
                                                                gain, improved feed           containing 0.125 to 1 mg
                                                                efficiency, and suppression   melengestrol acetate/lb to
                                                                of estrus (heat); and for     a feed containing 10 to 40
                                                                the prevention and control    g of monensin per ton to
                                                                of coccidiosis due to         provide 0.25 to 0.5 mg
                                                                Eimeria bovis and E.          melengestrol acetate/head/
                                                                zuernii..                     day and 0.14 to 0.42 mg
                                                                                              monensin/lb body weight,
                                                                                              depending on severity of
                                                                                              coccidiosis challenge, up
                                                                                              to 480 mg monensin/head/
                                                                                              day. See Sec.   558.355(d).
                                                                                              Monensin as provided by No.
                                                                                              016592 or 058198 in Sec.
                                                                                              510.600(c) of this chapter.
 
                                                                      * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------

* * * * *

0
62. In Sec.  558.355, remove and reserve paragraph (e) and revise 
paragraph (f)(4)(iv) to read as follows:

Sec.  558.355  Monensin.

* * * * *
    (f) * * *
    (4) * * *

----------------------------------------------------------------------------------------------------------------
          Monensin amount            Indications for use         Limitations                   Sponsor
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
(iv) 400 mg per pound of block      Pasture cattle        Provide 50 to 200 mg of    086113
 (0.088%).                           (slaughter,           monensin (2 to 8 ounces
                                     stocker, feeder,      of block) per head per
                                     and dairy and beef    day, at least 1 block
                                     replacement           per 5 head of cattle.
                                     heifers): For         Feed blocks
                                     increased rate of     continuously. Do not
                                     weight gain.          feed salt or mineral
                                                           supplements in addition
                                                           to the blocks. Ingestion
                                                           by cattle of monensin at
                                                           levels of 600 mg per
                                                           head per day and higher
                                                           has been fatal. The
                                                           effectiveness of this
                                                           block in cull cows and
                                                           bulls has not been
                                                           established. See
                                                           paragraph (d)(10)(i) of
                                                           this section.
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *

0
63. In Sec.  558.500, revise paragraph (e)(2) to read as follows:

Sec.  558.500  Ractopamine.

* * * * *
    (e) * * *
    (2) Cattle.

[[Page 18123]]

----------------------------------------------------------------------------------------------------------------
                                   Combination in      Indications for
   Ractopamine in  grams/ton          grams/ton              use               Limitations            Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 8.2 to 24.6................  ..................  Cattle fed in       Feed continuously as             054771
                                                      confinement for     sole ration during the          058198
                                                      slaughter: For      last 28 to 42 days on
                                                      increased rate of   feed.
                                                      weight gain and
                                                      improved feed
                                                      efficiency during
                                                      the last 28 to 42
                                                      days on feed.
(ii) 8.2 to 24.6...............  Monensin 10 to 40   Cattle fed in       Feed continuously as             016592
                                  to provide 0.14     confinement for     sole ration during the          054771
                                  to 0.42 mg          slaughter: For      last 28 to 42 days on           058198
                                  monensin/lb of      increased rate of   feed. See paragraph
                                  body weight,        weight gain and     Sec.   558.355(d).
                                  depending on        improved feed       Ractopamine as
                                  severity of         efficiency during   provided by No. 058198
                                  coccidiosis         the last 28 to 42   or 054771; monensin as
                                  challenge, up to    days on feed, and   provided by No. 016592
                                  480 mg/head/day..   for prevention      or 058198 in Sec.
                                                      and control of      510.600(c) of this
                                                      coccidiosis due     chapter.
                                                      to Eimeria bovis
                                                      and E. zuernii.
(iii) 9.8 to 24.6..............  ..................  Cattle fed in       Feed continuously as             054771
                                                      confinement for     sole ration during the          058198
                                                      slaughter: For      last 28 to 42 days on
                                                      increased rate of   feed. Not for animals
                                                      weight gain,        intended for breeding.
                                                      improved feed
                                                      efficiency, and
                                                      increased carcass
                                                      leanness during
                                                      the last 28 to 42
                                                      days on feed.
(iv) 9.8 to 24.6...............  Monensin 10 to 40   Cattle fed in       Feed continuously as             016592
                                  to provide 0.14     confinement for     sole ration during the          054771
                                  to 0.42 mg          slaughter: For      last 28 to 42 days on           058198
                                  monensin/lb of      increased rate of   feed. Not for animals
                                  body weight,        weight gain,        intended for breeding.
                                  depending on        improved feed       See paragraph Sec.
                                  severity of         efficiency, and     558.355(d).
                                  coccidiosis         increased carcass   Ractopamine as
                                  challenge, up to    leanness during     provided by No. 058198
                                  480 mg/head/day.    the last 28 to 42   or 054771; monensin as
                                                      days on feed, and   provided by No. 016592
                                                      for prevention      or 058198 in Sec.
                                                      and control of      510.600(c) of this
                                                      coccidiosis due     chapter.
                                                      to Eimeria bovis
                                                      and E. zuernii.
(v) 9.8 to 24.6................  Monensin 10 to 40   Heifers fed in      Feed continuously as             016592
                                  to provide 0.14     confinement for     sole ration during the          054771
                                  to 0.42 mg          slaughter: For      last 28 to 42 days on           058198
                                  monensin/lb of      increased rate of   feed. Not for animals
                                  body weight,        weight gain,        intended for breeding.
                                  depending on        improved feed       See Sec.  Sec.
                                  severity of         efficiency, and     558.342(d) and
                                  coccidiosis         increased carcass   558.355(d).
                                  challenge, up to    leanness during     Melengestrol acetate
                                  480 mg/head/day,    the last 28 to 42   as provided by No.
                                  plus melengestrol   days on feed, and   058198 or 054771;
                                  acetate to          for prevention      monensin as provided
                                  provide 0.25 to     and control of      by No. 016592 or
                                  0.5 mg/head/day.    coccidiosis due     058198 in Sec.
                                                      to Eimeria bovis    510.600(c) of this
                                                      and E. zuernii,     chapter.
                                                      and for
                                                      suppression of
                                                      estrus (heat).
(vi) Not to exceed 800; to       ..................  Cattle fed in       Top dress in a minimum           054771
 provide 70 to 400 mg/head/day.                       confinement for     of 1 lb of medicated            058198
                                                      slaughter: For      feed.
                                                      increased rate of
                                                      weight gain and
                                                      improved feed
                                                      efficiency during
                                                      the last 28 to 42
                                                      days on feed.
(vii) Not to exceed 800; to      Monensin 10 to 40   Cattle fed in       Top dress ractopamine            016592
 provide 70 to 400 mg/head/day.   to provide 0.14     confinement for     in a minimum of 1 lb            054771
                                  to 0.42 mg          slaughter: For      of medicated feed               058198
                                  monensin/lb of      increased rate of   during the last 28 to
                                  body weight,        weight gain and     42 days on feed. Not
                                  depending on        improved feed       for animals intended
                                  severity of         efficiency during   for breeding. See Sec.
                                  coccidiosis         the last 28 to 42     558.355(d).
                                  challenge, up to    days on feed, and   Ractopamine as
                                  480 mg/head/day.    for prevention      provided by No. 058198
                                                      and control of      or 054771; monensin as
                                                      coccidiosis due     provided by No. 016592
                                                      to Eimeria bovis    or 058198 in Sec.
                                                      and E. zuernii.     510.600(c) of this
                                                                          chapter.
----------------------------------------------------------------------------------------------------------------

* * * * *

0
64. In Sec.  558.618, revise paragraphs (e)(2)(ii) and (iii) to read as 
follows:

Sec.  558.618  Tilmicosin.

* * * * *
    (e) * * *
    (2) * * *

[[Page 18124]]

----------------------------------------------------------------------------------------------------------------
 Tilmicosin phosphate in grams/    Combination in      Indications for
              ton                     grams/ton              use               Limitations            Sponsor
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
(ii) 568 to 757................  Monensin, 5 to 40.  Cattle fed in       Feed continuously for            016592
                                                      confinement for     14 days to provide              058198
                                                      slaughter: For      12.5 mg tilmicosin/kg
                                                      improved feed       of bodyweight/day. The
                                                      efficiency; and     safety of tilmicosin
                                                      for the control     has not been
                                                      of bovine           established in cattle
                                                      respiratory         intended for breeding
                                                      disease (BRD)       purposes. This drug
                                                      associated with     product is not
                                                      Mannheimia          approved for use in
                                                      haemolytica,        female dairy cattle 20
                                                      Pasteurella         months of age or
                                                      multocida, and      older. Use in these
                                                      Histophilus somni   cattle may cause drug
                                                      in groups of        residues in milk. This
                                                      cattle fed in       drug product is not
                                                      confinement for     approved for use in
                                                      slaughter, where    calves intended to be
                                                      active BRD has      processed for veal. A
                                                      been diagnosed in   withdrawal period has
                                                      at least 10         not been established
                                                      percent of the      in pre-ruminating
                                                      animals in the      calves. Cattle
                                                      group.              intended for human
                                                                          consumption must not
                                                                          be slaughtered within
                                                                          28 days of the last
                                                                          treatment with this
                                                                          drug product. See Sec.
                                                                            558.355(d).
                                                                          Tilmicosin as provided
                                                                          by No. 016592 or
                                                                          058198; monensin as
                                                                          provided by No. 016592
                                                                          or 058198 in Sec.
                                                                          510.600(c) of this
                                                                          chapter.
(iii) 568 to 757...............  Monensin, 10 to 40  Cattle fed in       Feed continuously for            016592
                                                      confinement for     14 days to provide              058198
                                                      slaughter: For      12.5 mg tilmicosin/kg
                                                      prevention and      of bodyweight/day. The
                                                      control of          safety of tilmicosin
                                                      coccidiosis due     has not been
                                                      to Eimeria bovis    established in cattle
                                                      and E. zuernii;     intended for breeding
                                                      and for the         purposes. This drug
                                                      control of BRD      product is not
                                                      associated with     approved for use in
                                                      Mannheimia          female dairy cattle 20
                                                      haemolytica,        months of age or
                                                      Pasteurella         older. Use in these
                                                      multocida, and      cattle may cause drug
                                                      Histophilus somni   residues in milk. This
                                                      in groups of        drug product is not
                                                      cattle fed in       approved for use in
                                                      confinement for     calves intended to be
                                                      slaughter, where    processed for veal. A
                                                      active BRD has      withdrawal period has
                                                      been diagnosed in   not been established
                                                      at least 10         in pre-ruminating
                                                      percent of the      calves. Cattle
                                                      animals in the      intended for human
                                                      group.              consumption must not
                                                                          be slaughtered within
                                                                          28 days of the last
                                                                          treatment with this
                                                                          drug product. See Sec.
                                                                            558.355(d).
                                                                          Tilmicosin as provided
                                                                          by No. 016592 or
                                                                          058198; monensin as
                                                                          provided by No. 016592
                                                                          or 058198 in Sec.
                                                                          510.600(c) of this
                                                                          chapter.
----------------------------------------------------------------------------------------------------------------

0
65. In Sec.  558.625, revise paragraphs (e)(2)(vi) and (ix) to read as 
follows:

Sec.  558.625  Tylosin.

* * * * *
    (e) * * *
    (2) * * *

----------------------------------------------------------------------------------------------------------------
                                   Combination in      Indications for
       Tylosin grams/ton              grams/ton              use               Limitations            Sponsor
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
(vi) 8 to 10...................  Monensin, 5 to 30   Cattle fed in       Feed continuously as             016592
                                  plus decoquinate,   confinement for     the sole ration to              054771
                                  13.6 to 22.7.       slaughter: For      provide 22.7 mg of
                                                      reduction of        decoquinate per 100 lb
                                                      incidence of        body weight per day,
                                                      liver abscesses     50 to 360 mg of
                                                      caused by           monensin/head/day, and
                                                      Fusobacterium       60 to 90 mg of tylosin/
                                                      necrophorum and     head/day. Feed at
                                                      Arcanobacterium     least 28 days during
                                                      pyogenes; for the   period of exposure to
                                                      prevention of       coccidiosis or when it
                                                      coccidiosis         is likely to be a
                                                      caused by Eimeria   hazard. Do not feed to
                                                      bovis and E.        animals producing milk
                                                      zuernii; and for    for food. Do not feed
                                                      improved feed       to lactating dairy
                                                      efficiency.         cattle. A withdrawal
                                                                          time has not been
                                                                          established for pre-
                                                                          ruminating calves. Do
                                                                          not use in calves to
                                                                          be processed for veal.
                                                                          Tylosin as provided by
                                                                          No. 016592 or 058198;
                                                                          monensin as provided
                                                                          by No. 016592 or
                                                                          058198; decoquinate as
                                                                          provided by No. 058198
                                                                          in Sec.   510.600(c)
                                                                          of this chapter. See
                                                                          Sec.  Sec.
                                                                          558.311(d) and
                                                                          558.355(d).
 

[[Page 18125]]

 
                                                  * * * * * * *
(ix) 8 to 10...................  Monensin, 10 to 40  Heifers fed in      Feed continuously as             016592
                                  plus                confinement for     sole ration to heifers          054771
                                  melengestrol,       slaughter: For      at a rate of 0.5 to 2           058198
                                  0.25 to 2.0.        reduction of        pounds per head per
                                                      incidence of        day to provide 0.25 to
                                                      liver abscesses     0.5 mg/head/day
                                                      caused by           melengestrol acetate
                                                      Fusobacterium       and 0.14 to 0.42 mg
                                                      necrophorum and     monensin/lb body
                                                      Arcanobacterium     weight per day,
                                                      (Actinomyces)       depending on the
                                                      pyogenes; for       severity of the
                                                      prevention and      coccidiosis challenge,
                                                      control of          up to 480 mg/head/day
                                                      coccidiosis         and 60 to 90 mg/head/
                                                      caused by Eimeria   day tylosin. The
                                                      bovis and E.        melengestrol acetate
                                                      zuernii; and for    portion of this Type C
                                                      increased rate of   medicated feed must be
                                                      weight gain,        mixed into the
                                                      improved feed       complete feed
                                                      efficiency, and     containing 10 to 40 g/
                                                      suppression of      ton monensin and 8 to
                                                      estrus (heat).      10 g/ton tylosin at
                                                                          feeding into the
                                                                          amount of complete
                                                                          feed consumed by an
                                                                          animal per day. A
                                                                          withdrawal time has
                                                                          not been established
                                                                          for pre-ruminating
                                                                          calves. Do not use in
                                                                          calves to be processed
                                                                          for veal. Tylosin
                                                                          provided by No. 016592
                                                                          or 058198; monensin as
                                                                          provided by No. 016592
                                                                          or 058198;
                                                                          melengestrol provided
                                                                          by No. 054771 or
                                                                          058198 in Sec.
                                                                          510.600(c) of this
                                                                          chapter. See Sec.
                                                                          Sec.   558.342(d) and
                                                                          558.355(d).
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

0
66. In Sec.  558.635, revise paragraph (e)(1)(iv) to read as follows:

Sec.  558.635  Virginiamycin.

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

----------------------------------------------------------------------------------------------------------------
                                   Combination in      Indications for
    Virginiamycin grams/ton           grams/ton              use               Limitations            Sponsor
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
(iv) 20........................  Diclazuril, 0.91..  Broiler chickens:   Feed continuously as             058198
                                                      For prevention of   the sole ration. Do
                                                      necrotic            not use in hens
                                                      enteritis caused    producing eggs for
                                                      by Clostridium      human food. Diclazuril
                                                      perfringens         as provided by No.
                                                      susceptible to      058198 in Sec.
                                                      virginiamycin;      510.600(c) of this
                                                      and for the         chapter.
                                                      prevention of
                                                      coccidiosis
                                                      caused by Eimeria
                                                      tenella, E.
                                                      necatrix, E.
                                                      acervulina, E.
                                                      brunetti, E.
                                                      mitis (mivati),
                                                      and E. maxima.
                                                      Because
                                                      diclazuril is
                                                      effective against
                                                      E. maxima late in
                                                      its life cycle,
                                                      subclinical
                                                      intestinal
                                                      lesions may be
                                                      present for a
                                                      short time after
                                                      infection.
                                                      Diclazuril was
                                                      shown in studies
                                                      to reduce lesions
                                                      scores and
                                                      improve
                                                      performance and
                                                      health of birds
                                                      challenged with
                                                      E. maxima.
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *

    Dated: March 25, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-06688 Filed 3-30-20; 8:45 am]
BILLING CODE 4164-01-P