Document ID: FDA-2018-N-0002-0005
Agency: fda
Document Type: Rule
Title: New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsorship
Posted Date: 2019-03-13T04:00Z

[Federal Register Volume 84, Number 49 (Wednesday, March 13, 2019)]
[Rules and Regulations]
[Pages 8967-8982]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-04226]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 520, 522, 524, 526, 529, 556, and 558

[Docket No. FDA-2018-N-0002]

New Animal Drugs; Approval of New Animal Drug Applications; 
Withdrawal of Approval of New Animal Drug Applications; Changes of 
Sponsorship

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 July, August, and September 2018. 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 make technical 
amendments to improve the readability of the regulations.

DATES: This rule is effective March 13, 2019, except for amendatory 
instruction 25 to 21 CFR 520.2041, which is effective March 25, 2019.

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 July, August, and September 2018, 
as listed

[[Page 8968]]

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/AboutFDA/CentersOffices/OfficeofFoods/CVM/CVMFOIAElectronicReadingRoom/default.htm. Marketing 
exclusivity and patent information may be accessed in FDA's 
publication, Approved Animal Drug Products Online (Green Book) at: 
https://www.fda.gov/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/default.htm.

                          Table 1--Original and Supplemental NADAs and ANADAs Approved During July, August, and September 2018
--------------------------------------------------------------------------------------------------------------------------------------------------------
      Approval date        File No.          Sponsor              Product name             Species          Effect of the action     Public documents
--------------------------------------------------------------------------------------------------------------------------------------------------------
July 2, 2018.............   200-624  Modern Veterinary       REVERTIDINE            Dogs.................  Original approval as   FOI Summary.
                                      Therapeutics, LLC,      (atipamezole                                  a generic copy of
                                      14343 SW 119th Ave.,    hydrochloride)                                NADA 141-033.
                                      Miami, FL 33186.        Sterile Injectable
                                                              Solution.
July 6, 2018.............   200-495  Norbrook Laboratories,  ENROFLOX 100           Swine................  Supplemental approval  FOI Summary.
                                      Ltd., Station Works,    (enrofloxacin)                                of additional
                                      Newry BT35 6JP,         Injectable Solution.                          indications and
                                      Northern Ireland.                                                     routes of
                                                                                                            administration.
July 11, 2018............   138-952  Elanco US Inc., 2500    MAXIBAN 72 (narasin    Chickens.............  Supplemental approval  FOI Summary EA/
                                      Innovation Way,         and nicarbazin) Type                          of a revised tissue    FONSI.\1\
                                      Greenfield, IN 46140.   A medicated article.                          residue tolerance
                                                                                                            for nicarbazin and
                                                                                                            withdrawal period
                                                                                                            for narasin and
                                                                                                            nicarbazin Type C
                                                                                                            medicated feeds.
July 13, 2018............   200-484  Huvepharma EOOD, 5th    TYLOVET (tylosin       Swine and cattle.....  Supplemental approval  FOI Summary.
                                      Floor, 3A Nikolay       phosphate) Type A                             of a 40 g/lb
                                      Haytov Str., 1113       medicated articles.                           strength Type A
                                      Sophia, Bulgaria.                                                     medicated article.
July 13, 2018............   141-406  Merial, Inc., 3239      NEXGARD (afoxolaner)   Dogs.................  Supplemental approval  FOI Summary.
                                      Satellite Blvd.,        Chewable Tablets.                             for the prevention
                                      Bldg. 500, Duluth, GA                                                 of Borrelia
                                      30096-4640.                                                           burgdorferi
                                                                                                            infections as a
                                                                                                            direct result of
                                                                                                            killing Ixodes
                                                                                                            scapularis vector
                                                                                                            ticks.
July 30, 2018............   200-608  Piedmont Animal         BAYTRIL                Dogs.................  Original approval as   FOI Summary.
                                      Health, 204 Muirs       (enrofloxacin) Soft                           a generic copy of
                                      Chapel Rd., Suite       Chewable Tablets.                             NADA 140-441.
                                      200, Greensboro, NC
                                      27410.
August 3, 2018...........   141-461  Aratana Therapeutics,   NOCITA (bupivacaine    Cats.................  Supplemental approval  FOI Summary.
                                      Inc., 11400 Tomahawk    liposome injectable                           to provide for use
                                      Creek Pkwy., Leawood,   suspension).                                  as a peripheral
                                      KS 66211.                                                             nerve block to
                                                                                                            provide regional
                                                                                                            postoperative
                                                                                                            analgesia following
                                                                                                            onychectomy in cats.
August 8, 2018...........   141-439  Elanco US Inc., 2500    INTEPRITY              Chickens.............  Supplemental approval  FOI Summary EA/
                                      Innovation Way,         (avilamycin) Type A                           of a revised age       FONSI.\1\
                                      Greenfield, IN 46140.   medicated article.                            restriction caution
                                                                                                            statement from 10
                                                                                                            days to 18 days for
                                                                                                            use of avilamycin
                                                                                                            Type C medicated
                                                                                                            broiler feeds.
August 9, 2018...........   200-630  Aurora Pharmaceutical,  COCCIAID (amprolium)   Chickens and turkeys.  Original approval as   FOI Summary.
                                      LLC, 1196 Highway 3     9.6% Oral Solution.                           a generic copy of
                                      South, Northfield, MN                                                 NADA 013-149.
                                      55057-3009.
August 10, 2018..........   141-488  Zoetis Inc., 333        Lincomycin and         Chickens.............  Original approval for  FOI Summary.
                                      Portage St.,            lasalocid Type C                              use of LINCOMIX
                                      Kalamazoo, MI 49007.    medicated feeds.                              (lincomycin) and
                                                                                                            AVATEC (lasalocid)
                                                                                                            Type A medicated
                                                                                                            articles in the
                                                                                                            manufacture of Type
                                                                                                            C medicated broiler
                                                                                                            chicken feeds for
                                                                                                            the control of
                                                                                                            necrotic enteritis
                                                                                                            caused or
                                                                                                            complicated by
                                                                                                            Clostridium spp. or
                                                                                                            other organisms
                                                                                                            susceptible to
                                                                                                            lincomycin, and for
                                                                                                            the prevention of
                                                                                                            coccidiosis caused
                                                                                                            by Eimeria tenella,
                                                                                                            E. necatrix, E.
                                                                                                            acervulina, E.
                                                                                                            brunetti, E. mivati,
                                                                                                            and E maxima.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ The Agency has carefully considered an environmental assessment (EA) of the potential environmental impact of this action and has made a finding of
  no significant impact (FONSI).

II. Change of Sponsorship

    Piedmont Animal Health, 204 Muirs Chapel Rd., Suite 200, 
Greensboro, NC 27410 has informed FDA that it has transferred ownership 
of, and all rights and interest in, newly approved ANADA 200-608 for 
BAYTRIL (enrofloxacin) Soft Chewable Tablets to Bayer HealthCare LLC, 
Animal Health Division, P.O. Box 390, Shawnee Mission, KS 66201. 
Following this change of sponsorship, Piedmont Animal Health is no 
longer the sponsor of an approved application. Accordingly, it will not 
be added to the

[[Page 8969]]

list of sponsors of approved applications in Sec.  510.600(c) (21 CFR 
510.600(c)).
    Cronus Pharma LLC, 2 Tower Center Blvd., Suite 1101, East 
Brunswick, NJ 08816 has informed FDA that it has transferred ownership 
of, and all rights and interest in, the following applications to 
Cronus Pharma Specialities India Private Ltd., Sy No: 99/1, M/s GMR 
Hyderabad Aviation SEZ L, Mamidipalli Village, Shamshabad Mandal, 
Ranga, Hyderabad, Telangana 501218, India:

------------------------------------------------------------------------
           File No.                           Product name
------------------------------------------------------------------------
011-531......................  DIZAN (dithiazanine iodide) Tablets.
011-674......................  DIZAN (dithiazanine iodide) Powder.
012-469......................  DIZAN (dithiazanine iodide) Suspension
                                with Piperazine.
031-512......................  ATGARD (dichlorvos) Swine Wormer.
033-803......................  TASK (dichlorvos) Dog Anthelmintic.
035-918......................  EQUIGARD (dichlorvos).
039-483......................  BIO-TAL (thiamylal sodium).
040-848......................  ATGARD C (dichlorvos) Swine Wormer.
043-606......................  ATGARD V (dichlorvos) Swine Wormer.
045-143......................  OXIJECT (oxytetracycline hydrochloride).
047-278......................  BIO-MYCIN (oxytetracycline
                                hydrochloride).
047-712......................  BIZOLIN-100 (phenylbutazone).
048-010......................  ANAPLEX (dichlorophene and toluene)
                                Capsules.
048-237......................  EQUIGEL (dichlorvos).
048-271......................  TASK (dichlorvos) Tablets.
049-032......................  ATGARD C (dichlorvos) Premix.
055-002......................  TEVCOCIN (chloramphenicol).
065-461......................  ANACETIN (chloramphenicol) Tablets.
065-481......................  Chlortetracycline Calf Scour Boluses.
065-486......................  CTC Bisulfate (chlortetracycline
                                bisulfate) Soluble Powder.
065-491......................  MEDICHOL (chloramphenicol) Tablets.
092-837......................  NEMACIDE (diethylcarbamazine citrate)
                                Oral Syrup.
093-516......................  BIZOLIN (phenylbutazone) Injection 20%.
094-170......................  Phenylbutazone Tablets, U.S.P. 100 mg.
097-452......................  OXYJECT 100 (oxytetracycline
                                hydrochloride).
098-569......................  MEDACIDE-SDM (sulfadimethoxine) Injection
                                10%.
099-618......................  BIZOLIN (phenylbutazone) 1-gram.
108-963......................  MEDAMYCIN (oxytetracycline
                                hydrochloride).
117-689......................  NEUROSYN (primidone) Tablets.
123-815......................  Dexamethasone Sodium Phosphate Injection.
125-797......................  Nitrofurazone Dressing.
126-236......................  Nitrofurazone Soluble Powder.
126-676......................  D & T (dichlorophene and toluene) Worm
                                Capsules.
127-627......................  NEMACIDE-C (diethylcarbamazine citrate).
128-069......................  NEMACIDE (diethylcarbamazine citrate)
                                Chewable Tablets.
132-028......................  ANESTATAL (thiamylal sodium).
135-771......................  Methylprednisolene Tablets.
136-212......................  Methylprednisolone Acetate Injection.
137-310......................  Gentamicin Sulfate Injectable Solution.
138-869......................  Triamcinolone Acetonide Suspension.
140-442......................  Xylazine Hydrochloride Injection.
141-245......................  TRIBUTAME (chloroquine phosphate,
                                embutramid, lidocaine) Euthanasia
                                Solution.
200-023......................  Gentamicin Sulfate Solution 100 mg/mL.
200-029......................  Ketamine Hydrochloride Injection.
200-165......................  SDM Sulfadimethoxine Concentrated
                                Solution 12.5%.
200-178......................  Amikacin Sulfate Injection.
200-193......................  Clindamycin Hydrochloride Oral Liquid.
200-248......................  Pyrantel Pamoate Suspension.
200-265......................  Praziquantel Tablets.
200-287......................  GBC (gentamicin sulfate, betamethasone
                                valerate, clotrimazole) Ointment.
200-297......................  Ivermectin Chewable Tablets.
200-298......................  Clindamycin Hydrochloride Capsules.
200-365......................  ROBINUL (glycopyrrolate) Injection.
200-382......................  Furosemide Syrup 1%.
------------------------------------------------------------------------

    Following this change of sponsorship, Cronus Pharma LLC is no 
longer the sponsor of an approved application. Accordingly, it will be 
removed from the list of sponsors of approved applications in Sec.  
510.600(c). As a new sponsor of approved applications, Cronus Pharma 
Specialities India Private Ltd. will be added to Sec.  510.600(c); 
however, as the drug labeler code was not changed, no further 
amendments are necessary.
    Cross Vetpharm Group Ltd., Broomhill Rd., Tallaght, Dublin 24, 
Ireland has informed FDA that it has transferred ownership of, and all 
rights and interest in, the following applications to Bimeda Animal 
Health Ltd., 1B The Herbert Building, The Park, Carrickmines, Dublin 
18, Ireland:

[[Page 8970]]

------------------------------------------------------------------------
   File No.                Product name               21 CFR  section
------------------------------------------------------------------------
010-092.......  GALLIMYCIN-100P (erythromycin      558.248.
                 thiocyanate) Type A Medicated
                 Article.
010-346.......  COMBUTHAL (pentobarbital sodium    522.2444b.
                 and thiopental sodium) Powder.
012-123.......  GALLIMYCIN-100 (erythromycin )     522.820.
                 Injectable.
035-157.......  GALLIMYCIN PFC (erythromycin       520.823.
                 phosphate) Powder.
035-455.......  GALLIMYCIN-36 (erythromycin) Dry   526.820.
                 Cow Intramammary Infusion.
035-456.......  GALLIMYCIN-36 (erythromycin)       526.820.
                 Sterile Intramammary Infusion.
038-661.......  SPECTOGARD (spectinomycin) Water   520.2123b.
                 Soluble Powder.
044-756.......  BUTATRON (phenylbutazone) Tablets  520.1720a.
046-780.......  PHEN-BUTA (phenylbutazone) Vet     522.1720.
                 Injection.
049-187.......  PHEN-BUTA (phenylbutazone) Vet     520.1720a.
                 Tablets.
055-059.......  VICETRON (chloramphenicol)         520.390a.
                 Tablets.
065-383.......  UNIBIOTIC (penicillin G procaine)  526.1696a.
                 Intramammary Infusion.
065-505.......  PRO-PEN-G (penicillin G procaine)  522.1696b.
                 Injectable Suspension.
065-506.......  COMBI-PEN-48 (penicillin G         522.1696a.
                 benzathine and penicillin G
                 procaine) Injectable Suspension.
092-150.......  PURINA (pyrantel tartrate) Horse   520.2046.
                 & Colt Wormer Pellets.
093-515.......  SPECTAM (spectinomycin) Tablets..  520.2123a.
095-218.......  DEXIUM (dexamethasone) Tablets...  520.540b.
096-671.......  PHEN-BUTA-Vet (phenylbutazone)     522.1720.
                 Injection.
096-672.......  PHEN-BUTA (phenylbutazone) Vet     520.1720a.
                 Tablets.
098-288.......  PREDNIS-A-Vet (prednisolone        522.1883.
                 sodium phosphate) Injection.
099-169.......  Oxytocin Injection...............  522.1680.
099-604.......  DEX-A-VET (dexamethasone)          522.540.
                 Injection.
099-605.......  DEX-A-VET (dexamethasone)          522.540.
                 Injection.
099-606.......  DEXAMETH-A-Vet (dexamethasone )    522.540.
                 Injection.
099-607.......  DEXAMETH-A-Vet (dexamethasone)     522.540.
                 Injection.
101-690.......  ERYTHRO-100 (erythromycin)         522.820.
                 Injection.
107-506.......  CARBAM (diethylcarbamazine         520.622a.
                 citrate) Tablets.
109-305.......  Oxytocin Injection...............  522.1680.
118-032.......  PALATABS (diethylcarbamazine       520.622a.
                 citrate) Tablets.
118-550.......  FUROS-A-Vet (furosemide).........  522.1010.
118-979.......  BUTATRON (phenylbutazone) Gel....  520.1720d.
119-141.......  TRANQUAZINE (promazine             522.1962.
                 hydrochloride) Injection.
120-615.......  SUSTAIN III (sulfamethazine)       520.2260b.
                 Bolus.
122-447.......  FURA-SEPTIN (Nitrofurazone)        524.1580a.
                 Soluble Dressing.
124-241.......  PVL Oxytocin Injection...........  522.1680.
126-504.......  Nitrofurazone Ointment...........  524.1580a.
130-136.......  Oxytocin Injection...............  522.1680.
138-405.......  Pyrilamine Maleate Injection.....  522.2063.
140-582.......  Oxytetracycline Hydrochloride      522.1662a.
                 Injection.
140-583.......  ACTH (adrenocorticotropic          522.480.
                 hormone) Gel.
141-420.......  TILDREN (tiludronate disodium)     522.2473.
                 Powder for Injection.
200-050.......  NEOMED (neomycin sulfate) Soluble  520.1484.
                 Powder.
200-069.......  FERTELIN (gonadorelin diacetate    522.1077.
                 tetrahydrate).
200-103.......  PENAQUA Sol-G (penicillin G        520.1696b.
                 potassium, USP) Soluble Powder.
200-115.......  GENTAMEX 100 (gentamicicn          529.1044a.
                 sulfate).
200-117.......  OXYSHOT-LA (oxytetracycline)       522.1660a.
                 Injectable Solution.
200-144.......  TETROXY HCA-280 (oxytetracycline   520.1660d.
                 hydrochloride) Soluble Powder.
200-146.......  TETROXY 25 (oxytetracycline        520.1660d.
                 hydrochloride) Soluble Powder.
200-176.......  PRAZITECH (praziquantel)           522.1870.
                 Injection.
200-247.......  TETROXY 343 (oxytetracycline       520.1660d.
                 hydrochloride) Soluble Powder.
200-253.......  PROSTAMATE (dinoprost              522.690.
                 tromethamine) Injectable
                 Solution.
200-312.......  DEXIUM (dexamethasone) Injection.  522.540.
200-313.......  LEVAMED (levamisole                520.1242a.
                 hydrochloride) Soluble Powder.
200-317.......  DEXIUM-SP (dexamethasone sodium    522.540.
                 phosphate) Injection.
200-318.......  BIMECTIN (ivermectin) Pour-On....  524.1193.
200-326.......  BIMECTIN (ivermectin) Paste......  520.1192.
200-328.......  Oxytocin Injection...............  522.1680.
200-350.......  EXODUS (pyrantel pamoate) Paste..  520.2044.
200-364.......  SPECTOGARD SCOUR-CHEK              520.2123c.
                 (spectinomycin dihydrochloride
                 pentahydrate) Oral Solution.
200-368.......  LINCOMED 100 (lincomycin           522.1260.
                 hydrochloride) Injectable
                 Solution.
200-374.......  TETRAMED 324 HCA (tetracycline     520.2345d.
                 hydrochloride) Soluble Powder.
200-376.......  SULFAMED-G (sulfadimethoxine)      520.2220a.
                 Soluble Powder.
200-377.......  LINXMED-SP (lincomycin             520.1263c.
                 hydrochloride) Soluble Powder.
200-380.......  SPECLINX-50 (lincomycin            520.1265.
                 hydrochloride monohydrate and
                 spectinomycin dihydrochloride
                 pentahydrate) Soluble Powder.
200-386.......  LEVAMED (levamisole                520.1242a.
                 hydrochloride) Soluble Drench
                 Powder.
200-387.......  FLUNAZINE (flunixin meglumine)     522.970.
                 Injection.
200-391.......  Griseofulvin Powder..............  520.1100.
200-434.......  SMZ-Med 454 (sodium                520.2261b.
                 sulfamethazine) Soluble Powder.
200-447.......  BIMECTIN (ivermectin) Injection    522.1192.
                 for Cattle and Swine.
200-455.......  BILOVET (tylosin tartrate)         520.2640.
                 Soluble Powder.
200-460.......  TETROXY (oxytetracycline           529.1660.
                 hydrochloride) Aquatic.
200-464.......  AMPROMED (amprolium) For Cattle..  520.100.

[[Page 8971]]

 
200-468.......  GENTAMED-P (gentamicin sulfate)    522.1044.
                 for Poultry Injection.
200-481.......  OVAMED (altrenogest) Solution....  520.48.
200-482.......  AMPROMED (amprolium) for Calves..  520.100.
200-488.......  AMPROMED P (amprolium) for         520.100.
                 Poultry.
200-489.......  FLUNAZINE-S (flunixin meglumine)   522.970.
                 Injection.
200-494.......  GENTAMED (gentamicin sulfate)      520.1044c.
                 Soluble Powder.
200-496.......  AMPROMED P (amprolium) for         520.100.
                 Poultry.
200-501.......  Praziquantel Injection...........  522.1870.
200-508.......  BILOVET (tylosin) Injectable       522.2640.
                 Solution.
200-523.......  SULFAMED (sulfadimethoxine)        522.2220.
                 Injection.
200-529.......  XYLAMED (xylazine) Injection.....  522.2662.
200-538.......  CLINDAMED (clindamycin) Oral       520.447.
                 Drops.
200-581.......  FLUNAZINE (flunixin meglumine)     520.970.
                 Paste.
------------------------------------------------------------------------

    Following this change of sponsorship, Cross Vetpharm Group Ltd. is 
no longer the sponsor of an approved application. Accordingly, it will 
be removed from the list of sponsors of approved applications in Sec.  
510.600(c) (21 CFR 510.600(c)). As a new sponsor of approved 
applications, Bimeda Animal Health Ltd. will be added to Sec.  
510.600(c) and the regulations amended to reflect this action. As 
provided in the regulatory text of this document, the animal drug 
regulations are amended to reflect these changes of sponsorship.

III. Withdrawals of Approval

    Elanco US Inc., 2500 Innovation Way, Greenfield, IN 46140, has 
requested that FDA withdraw approval of NADA 140-939 for use of 
RUMENSIN (monensin) and TYLAN (tylosin phosphate) Type A medicated 
articles in the manufacture of combination drug Type C medicated cattle 
feeds because the product is no longer manufactured or marketed.
    Also, Sergeant's Pet Care Products, Inc., 10077 S 134th St., Omaha, 
NE 68138 has requested that FDA withdraw approval of ANADA 200-600 for 
WORMX (pyrantel pamoate) Flavored Tablets because the product is no 
longer manufactured or marketed.
    Elsewhere in this issue of the Federal Register, FDA gave notice 
that approval of NADA 140-939 and ANADA 200-600, and all supplements 
and amendments thereto, is withdrawn, effective March 25, 2019. As 
provided in the regulatory text of this document, the animal drug 
regulations are amended to reflect these actions.

IV. Technical Amendments

    In addition, we are reformatting the regulations to present the 
approved conditions of use of halofuginone, monensin, and salinomycin 
in tabular format in the respective named sections of 21 CFR part 558. 
This action is being taken to improve the readability of the 
regulations.

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) because it 
is a ``rule of particular applicability'' under 5 U.S.C. 804(3)(A). 
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 Parts 520, 522, 524, 526, and 529

    Animal drugs.

21 CFR Part 556

    Animal drugs, Foods.

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, 520, 522, 524, 526, 529, 556, 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, in the table in paragraph (c)(1), remove the 
entries for ``Cronus Pharma LLC'' and ``Cross Vetpharm Group Ltd.'' and 
alphabetically add entries for ``Bimeda Animal Health Ltd.'' and 
``Cronus Pharma Specialities India Private Ltd.''; and in the table in 
paragraph (c)(2), numerically add an entry for ``061133'', remove the 
entry for ``061623'', and revise the entry for ``069043''.
    The additions and revisions 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
------------------------------------------------------------------------
 
                              * * * * * * *
Bimeda Animal Health Ltd., 1B The Herbert Building, The           061133
 Park, Carrickmines, Dublin 18, Ireland.................

[[Page 8972]]

 
 
                              * * * * * * *
Cronus Pharma Specialities India Private Ltd., Sy No: 99/         069043
 1, M/s GMR Hyderabad Aviation SEZ L, Mamidipalli
 Village, Shamshabad Mandal, Ranga, Hyderabad,
 Telangana, 501218, India...............................
 
                              * * * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
    Drug labeler code                  Firm name and address
------------------------------------------------------------------------
 
                              * * * * * * *
061133..................  Bimeda Animal Health Ltd., 1B The Herbert
                           Building, The Park, Carrickmines, Dublin 18,
                           Ireland.
 
                              * * * * * * *
069043..................  Cronus Pharma Specialities India Private Ltd.,
                           Sy No: 99/1, M/s GMR Hyderabad Aviation SEZ
                           L, Mamidipalli Village, Shamshabad Mandal,
                           Ranga, Hyderabad, Telangana, 501218, India.
 
                              * * * * * * *
------------------------------------------------------------------------

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

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

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

0
4. In Sec.  520.43, revise paragraph (c)(2) to read as follows:

Sec.  520.43  Afoxolaner.

* * * * *
    (c) * * *
    (2) Indications for use. Kills adult fleas; for the treatment and 
prevention of flea infestations (Ctenocephalides felis); for the 
treatment and control of black-legged tick (Ixodes scapularis), 
American dog tick (Dermacentor variabilis), lone star tick (Amblyomma 
americanum), and brown dog tick (Rhipicephalus sanguineus) infestations 
in dogs and puppies 8 weeks of age and older, weighing 4 pounds of body 
weight or greater, for 1 month; and for the prevention of Borrelia 
burgdorferi infections as a direct result of killing Ixodes scapularis 
vector ticks.
* * * * *

Sec.  520.48  [Amended]

0
5. In Sec.  520.48, in paragraph (b), remove ``061623'' and in its 
place add ``061133''.

Sec.  520.100  [Amended]

0
6. In Sec.  520.100, in paragraph (b)(1), remove ``No. 016592'' and in 
its place add ``Nos. 016592 and 061133''; and in paragraph (b)(2), 
remove ``No. 066104'' and in its place add ``Nos. 051072 and 066104''.

Sec.  520.390a  [Amended]

0
7. In Sec.  520.390a, in paragraph (b)(2)(i), remove ``061623'' and in 
its place add ``061133''.

Sec.  520.447  [Amended]

0
8. In Sec.  520.447, in paragraph (b), remove ``061623'' and in its 
place add ``061133''.

Sec.  520.540b  [Amended]

0
9. In Sec.  520.540b, in paragraph (b)(2), remove ``061623'' and in its 
place add ``061133''.

Sec.  520.622a  [Amended]

0
10. In Sec.  520.622a, in paragraph (a)(3), remove ``061623'' and in 
its place add ``061133''.

0
11. In Sec.  520.812, revise paragraphs (a) and (b)(1) and (2) and add 
paragraph (b)(3) to read as follows:

Sec.  520.812  Enrofloxacin.

    (a) Specifications--(1) Each tablet contains:
    (i) 2.7, 68.0, or 136.0 milligrams (mg) enrofloxacin; or
    (ii) 22.7, 68.0, 136.0, or 272 mg enrofloxacin.
    (2) Each soft chewable tablet contains 22.7, 68.0, or 136.0 mg 
enrofloxacin.
    (b) * * *
    (1) Nos. 000859 and 026637 for use of product described in 
paragraph (a)(1)(i) of this section.
    (2) No. 058198 for use of product described in paragraph (a)(1)(ii) 
of this section.
    (3) No. 000859 for use of product described in paragraph (a)(2) of 
this section.
* * * * *

Sec.  520.823  [Amended]

0
12. In Sec.  520.823, in paragraph (b), remove ``061623'' and in its 
place add ``061133''.

Sec.  520.970  [Amended]

0
13. In Sec.  520.970, in paragraph (b)(2), remove ``061623'' and in its 
place add ``061133''.

Sec.  520.1044c  [Amended]

0
14. In Sec.  520.1044c, in paragraph (b)(2), remove ``061623'' and in 
its place add ``061133''.

Sec.  520.1100  [Amended]

0
15. In Sec.  520.1100, in paragraph (b)(2), remove ``061623'' and in 
its place add ``061133''.

Sec.  520.1192  [Amended]

0
16. In Sec.  520.1192, in paragraph (b)(2), remove ``061623'' and in 
its place add ``061133''.

Sec.  520.1242a  [Amended]

0
17. In Sec.  520.1242a, in paragraph (b)(4), remove ``059130'' and in 
its place add ``061133''.

Sec.  520.1263c  [Amended]

0
18. In Sec.  520.1263c, in paragraph (b)(2), remove ``061623'' and in 
its place add ``061133''.

Sec.  520.1265  [Amended]

0
19. In Sec.  520.1265, in paragraph (b)(2), remove ``061623'' and in 
its place add ``061133''.

[[Page 8973]]

Sec.  520.1484  [Amended]

0
20. In Sec.  520.1484, in paragraph (b)(2), remove ``061623'' and in 
its place add ``061133''.

Sec.  520.1660d  [Amended]

0
21. In Sec.  520.1660d, in paragraphs (b)(5), (b)(7), (d)(1)(ii)(A)(3), 
(d)(1)(ii)(B)(3), (d)(1)(ii)(C)(3), and (d)(1)(iii)(C), remove 
``061623'' and in its place add ``061133''.

Sec.  520.1696b  [Amended]

0
22. In Sec.  520.1696b, in paragraph (b), remove ``061623'' and in its 
place add ``061133''.

Sec.  520.1720a  [Amended]

0
23. In Sec.  520.1720a, in paragraph (b)(3), remove ``061623'' and in 
its place add ``061133''.

Sec.  520.1720d  [Amended]

0
24. In Sec.  520.1720d, in paragraph (b), remove ``061623'' and in its 
place add ``061133''.

Sec.  520.2041  [Amended]

0
25. Effective March 25, 2019, in Sec.  520.2041, in paragraph (b), 
remove ``066916, 017135,'' and add in its place ``017135''.

Sec.  520.2044  [Amended]

0
26. In Sec.  520.2044, in paragraph (b)(3), remove ``061623'' and in 
its place add ``061133''.

Sec.  520.2046  [Amended]

0
27. In Sec.  520.2046, in paragraph (b)(2), remove ``061623'' and in 
its place add ``061133''.

Sec.  520.2123a  [Amended]

0
28. In Sec.  520.2123a, in paragraph (b), remove ``061623'' and in its 
place add ``061133''.

Sec.  520.2123b  [Amended]

0
29. In Sec.  520.2123b, in paragraph (b), remove ``061623'' and in its 
place add ``061133''.

Sec.  520.2123c  [Amended]

0
30. In Sec.  520.2123c, in paragraph (b), remove ``061623'' and in its 
place add ``061133''.

Sec.  520.2220a  [Amended]

0
31. In Sec.  520.2220a, in paragraph (b)(2), remove ``061623'' and in 
its place add ``061133''.

Sec.  520.2260b  [Amended]

0
32. In Sec.  520.2260b, in paragraphs (c)(1) and (e)(1), remove 
``061623'' and in its place add ``061133''.

Sec.  520.2261b  [Amended]

0
33. In Sec.  520.2261b, in paragraph (b), remove ``061623'' and in its 
place add ``061133''.

Sec.  520.2345d  [Amended]

0
34. In Sec.  520.2345d, in paragraph (b)(4), remove ``061623'' and in 
its place add ``061133''; and in paragraphs (d)(1)(iii) and 
(d)(2)(iii), remove ``059130, and 061623'' and in its place add ``and 
061133''.

Sec.  520.2640  [Amended]

0
35. In Sec.  520.2640, in paragraph (b)(2), remove ``061623'' and in 
its place add ``061133''.

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

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

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

Sec.  522.147  [Amended]

0
37. In Sec.  522.147, in paragraph (b), remove ``No. 052483'' and in 
its place add ``Nos. 015914 and 052483''.

0
38. In Sec.  522.224, revise paragraph (c) to read as follows:

Sec.  522.224  Bupivacaine.

* * * * *
    (c) Conditions of use--(1) Dogs--(i) Amount. Administer 5.3 mg/kg 
(0.4 mL/kg) by infiltration injection into the tissue layers at the 
time of incisional closure.
    (ii) Indications for use. For single-dose infiltration into the 
surgical site to provide local postoperative analgesia for cranial 
cruciate ligament surgery.
    (2) Cats--(i) Amount. Administer 5.3 mg/kg per forelimb (0.4 mL/kg 
per forelimb), for a total dose of 10.6 mg/kg/cat, as a 4-point nerve 
block prior to onychectomy.
    (ii) Indications for use. For use as a peripheral nerve block to 
provide regional postoperative analgesia following onychectomy.

Sec.  522.480  [Amended]

0
39. In Sec.  522.480, in paragraph (b)(1), remove ``061623'' and in its 
place add ``061133''.

Sec.  522.540  [Amended]

0
40. In Sec.  522.540, in paragraphs (a)(2)(i), (b)(2), and (c)(2), 
remove ``061623'' and in its place add ``061133''.

Sec.  522.690  [Amended]

0
41. In Sec.  522.690, in paragraph (b)(3), remove ``061623'' and in its 
place add ``061133''.

0
42. In Sec.  522.812, revise paragraph (b)(1); remove paragraph (b)(2) 
and redesignate paragraph (b)(3) as paragraph (b)(2); remove paragraph 
(e)(3)(i)(B) and redesignate paragraph (e)(3)(i)(C) as (e)(3)(i)(B); 
and revise paragraphs (e)(3)(i)(A) and newly designated (e)(3)(i)(B).
    The revisions read as follows:

Sec.  522.812  Enrofloxacin.

* * * * *
    (b) * * *
    (1) Nos. 000859 and 055529 for use of product described in 
paragraph (a)(1) of this section as in paragraph (e)(1) of this 
section, and use of product described in paragraph (a)(2) of this 
section as in paragraphs (e)(2) and (3) of this section.
* * * * *
    (e) * * *
    (3) * * *
    (i) * * *
    (A) Administer 7.5 mg/kg of body weight once, by intramuscular or 
subcutaneous injection behind the ear, for the treatment and control of 
swine respiratory disease (SRD) associated with Actinobacillus 
pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis, 
Streptococcus suis, Bordetella bronchiseptica, and Mycoplasma 
hyopneumoniae.
    (B) Administer 7.5 mg/kg of body weight once, by intramuscular or 
subcutaneous injection behind the ear, for the control of 
colibacillosis in groups or pens of weaned pigs where colibacillosis 
associated with Escherichia coli has been diagnosed.
* * * * *

Sec.  522.820  [Amended]

0
43. In Sec.  522.820, in paragraph (b), remove ``061623'' and in its 
place add ``061133''.

Sec.  522.970  [Amended]

0
44. In Sec.  522.970, in paragraph (b)(1), remove ``061623'' and in its 
place add ``061133''.

Sec.  522.1010  [Amended]

0
45. In Sec.  522.1010, in paragraph (b)(2), remove ``061623'' and in 
its place add ``061133''.

Sec.  522.1044  [Amended]

0
46. In Sec.  522.1044, in paragraph (b)(4), remove ``061623'' and in 
its place add ``061133''.

Sec.  522.1077  [Amended]

0
47. In Sec.  522.1077, in paragraph (b)(3), remove ``061623'' and in 
its place add ``061133''.

[[Page 8974]]

Sec.  522.1192  [Amended]

0
48. In Sec.  522.1192, in paragraph (b)(2), remove ``061623'' and in 
its place add ``061133''.

Sec.  522.1260  [Amended]

0
49. In Sec.  522.1260, in paragraph (b)(4), remove ``061623'' and in 
its place add ``061133''.

Sec.  522.1660a  [Amended]

0
50. In Sec.  522.1660a, in paragraph (b), remove ``061623'' and in its 
place add ``061133''.

Sec.  522.1662a  [Amended]

0
51. In Sec.  522.1662a, in paragraph (k)(2), remove ``061623'' and in 
its place add ``061133''.

Sec.  522.1680  [Amended]

0
52. In Sec.  522.1680, in paragraph (b), remove ``061623'' and in its 
place add ``061133''.

Sec.  522.1696a  [Amended]

0
53. In Sec.  522.1696a, in paragraphs (b)(1), (b)(2), and (d)(2)(iii), 
remove ``061623'' and in its place add ``061133''; and in paragraphs 
(d)(1)(ii) and (d)(2)(ii), remove ``Conditions of use'' and in its 
place add ``Indications for use''.

Sec.  522.1696b  [Amended]

0
54. In Sec.  522.1696b, in paragraphs (b)(2), (d)(2)(i)(A), and 
(d)(2)(iii)(A), remove ``061623'' and in its place add ``061133''.

Sec.  522.1720  [Amended]

0
55. In Sec.  522.1720, in paragraph (b)(2), remove ``061623'' and in 
its place add ``061133''.

Sec.  522.1870  [Amended]

0
56. In Sec.  522.1870, in paragraph (b), remove ``061623'' and in its 
place add ``061133''.

Sec.  522.1883  [Amended]

0
57. In Sec.  522.1883, in paragraph (b), remove ``061623'' and in its 
place add ``061133''.

Sec.  522.1962  [Amended]

0
58. In Sec.  522.1962, in paragraph (b)(2), remove ``061623'' and in 
its place add ``061133''.

Sec.  522.2063  [Amended]

0
59. In Sec.  522.2063, in paragraph (b)(2), remove ``061623'' and in 
its place add ``061133''.

Sec.  522.2220  [Amended]

0
60. In Sec.  522.2220, in paragraph (b)(3), remove ``061623'' and in 
its place add ``061133''.

Sec.  522.2444b  [Amended]

0
61. In Sec.  522.2444b, in paragraph (b), remove ``061623'' and in its 
place add ``061133''.

Sec.  522.2473  [Amended]

0
62. In Sec.  522.2473, in paragraph (b), remove ``061623'' and in its 
place add ``061133''.

Sec.  522.2640  [Amended]

0
63. In Sec.  522.2640, in paragraph (b)(2), remove ``061623'' and in 
its place add ``061133''.

Sec.  522.2662  [Amended]

0
64. In Sec.  522.2662, in paragraph (b)(2), remove ``061623'' and in 
its place add ``061133''.

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

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

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

Sec.  524.1193  [Amended]

0
66. In Sec.  524.1193, in paragraph (b)(1), remove ``061623'' and in 
its place add ``061133''.

Sec.  524.1580a  [Amended]

0
67. In Sec.  524.1580a, in paragraph (b)(1), remove ``061623'' and in 
its place add ``061133''.

PART 526--INTRAMAMMARY DOSAGE FORM NEW ANIMAL DRUGS

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

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

Sec.  526.820  [Amended]

0
69. In Sec.  526.820, in paragraph (b), remove ``061623'' and in its 
place add ``061133''.

Sec.  526.1696a  [Amended]

0
70. In Sec.  526.1696a, in paragraph (c), remove ``061623'' and in its 
place add ``061133''.

PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

0
71. The authority citation for part 529 continues to read as follows:

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

Sec.  529.1044a  [Amended]

0
72. In Sec.  529.1044a, in paragraph (b), remove ``061623'' and in its 
place add ``061133''.

Sec.  529.1660  [Amended]

0
73. In Sec.  529.1660, in paragraphs (b)(1) and (2), remove ``061623'' 
and in its place add ``061133''.

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

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

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

0
75. In Sec.  556.445, add paragraph (a) and revise paragraph (b) to 
read as follows:

Sec.  556.445  Nicarbazin.

    (a) Acceptable daily intake (ADI). The ADI for total residues of 
nicarbazin (4,4'-dinitrocarbanilide and 2-hydroxy-4,6-
dimethylpyrimidine) is 200 micrograms per kilogram of body weight per 
day.
    (b) Tolerance. The tolerance for 4,4'-dinitrocarbanilide (marker 
residue) is:
    (1) Chickens--Liver (target tissue): 52 ppm.
    (2) [Reserved]
* * * * *

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

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

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

0
77. In Sec.  558.4, in paragraph (d), in the ``Category I'' table, 
revise the entry for ``Narasin'', alphabetically add an entry for 
``Nicarbazin (granular)'' followed immediately by an indented entry for 
``Narasin''; and in the ``Category II'' table, remove the entry for 
``Narasin'' and revise the entry for ``Nicarbazin (powder)''.
    The revisions and addition read as follows:

Sec.  558.4  Requirement of a medicated feed mill license.

* * * * *
    (d) * * *

[[Page 8975]]

                                                   Category I
----------------------------------------------------------------------------------------------------------------
                                                Assay limits                                      Assay limits
                    Drug                      percent \1\ Type      Type B maximum (200x)       percent \1\ Type
                                                     A                                              B/C \2\
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
Narasin....................................             90-110  9.0 g/lb (1.98%).............     85-115/75-125.
Nicarbazin (granular)......................             90-110  9.0 g/lb (1.98%).............     85-115/75-125.
Narasin....................................             90-110  9.0 g/lb (1.98%).............     85-115/75-125.
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
\1\ Percent of labeled amount.
\2\ Values given represent ranges for either Type B or Type C medicated feeds. For those drugs that have two
  range limits, the first set is for a Type B medicated feed and the second set is for a Type C medicated feed.
  These values (ranges) have been assigned in order to provide for the possibility of dilution of a Type B
  medicated feed with lower assay limits to make a Type C medicated feed.

                                                   Category II
----------------------------------------------------------------------------------------------------------------
                                                Assay limits                                      Assay limits
                    Drug                      percent \1\ Type      Type B maximum (100x)       percent \1\ Type
                                                     A                                              B/C \2\
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
Nicarbazin (powder)........................             90-110  9.08 g/lb (2.00%)............     85-115/75-125.
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
\1\ Percent of labeled amount.
\2\ Values given represent ranges for either Type B or Type C medicated feeds. For those drugs that have two
  range limits, the first set is for a Type B medicated feed and the second set is for a Type C medicated feed.
  These values (ranges) have been assigned to provide for the possibility of dilution of a Type B medicated feed
  with lower assay limits to make a Type C medicated feed.

* * * * *

Sec.  558.68  [Amended]

0
78. In Sec.  558.68, in paragraph (e)(1)(i), in the ``Limitations'' 
column, remove ``10 days of age'' and in its place add ``18 days of 
age''.

Sec.  558.128  [Amended]

0
79. In Sec.  558.128, in paragraph (e)(4)(iv), in the row for ``1.'', 
in the ``Limitations'' column, remove ``sponsor No. 069254'' and in its 
place add ``sponsor Nos. 054771 and 069254''.

Sec.  558.248  [Amended]

0
80. In Sec.  558.248, in paragraph (b), remove ``061623'' and in its 
place add ``061133''.

0
81. In Sec.  558.265, revise paragraphs (b) and (d) to read as follows:

Sec.  558.265  Halofuginone.

* * * * *
    (b) Sponsor. See No. 016592 in Sec.  510.600(c) of this chapter.
* * * * *
    (d) Conditions of use. It is used in feed as follows:
    (1) Chickens--

----------------------------------------------------------------------------------------------------------------
                                  Combination in
   Halofuginone in grams/ton        grams/ton        Indications for use        Limitations           Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 2.72......................  .................  Broiler chickens: For   Feed continuously as           016592
                                                    the prevention of       sole ration. Do not
                                                    coccidiosis caused by   feed to layers.
                                                    Eimeria tenella, E.     Withdraw 4 days
                                                    necatrix, E.            before slaughter.
                                                    acervulina, E.
                                                    brunetti, E. mivati,
                                                    and E. maxima.
(ii) 2.72.....................  Bacitracin         Broiler chickens: For   Feed continuously as           016592
                                 methylenedisalic   the prevention of       sole ration. Do not
                                 ylate, 10 to 50.   coccidiosis caused by   feed to layers.
                                                    Eimeria tenella, E.     Withdraw 5 days
                                                    necatrix, E.            before slaughter.
                                                    acervulina, E.
                                                    brunetti, E. mivati,
                                                    and E. maxima; for
                                                    improved feed
                                                    efficiency.
(iii) 2.72....................  Bambermycins, 1    Broiler chickens: For   Feed continuously as           016592
                                 to 2.              the prevention of       sole ration. Do not
                                                    coccidiosis caused by   feed to layers.
                                                    Eimeria tenella, E.     Withdraw 5 days
                                                    necatrix, E,            before slaughter.
                                                    acervulina, E.
                                                    brunetti, E. mivati,
                                                    and E. maxima; for
                                                    increased rate of
                                                    weight gain and
                                                    improved feed
                                                    efficiency.
(iv) 2.72.....................  .................  Replacement broiler     Feed continuously as           016592
                                                    breeder chickens and    sole ration to
                                                    replacement cage        replacement cage
                                                    laying chickens: For    laying chickens
                                                    the prevention of       until 20 weeks of
                                                    coccidiosis caused by   age. Feed
                                                    Eimeria tenella, E.     continuously as sole
                                                    necatrix, E.            ration to
                                                    acervulina, E.          replacement broiler
                                                    maxima, E. mivati/E.    breeder chickens
                                                    mitis, and E.           until 16 weeks of
                                                    brunetti.               age. Do not feed to
                                                                            laying chickens or
                                                                            water fowl. Withdraw
                                                                            4 days before
                                                                            slaughter.
----------------------------------------------------------------------------------------------------------------

[[Page 8976]]

    (2) Turkeys--

----------------------------------------------------------------------------------------------------------------
                                  Combination in
   Halofuginone in grams/ton        grams/ton        Indications for use        Limitations           Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 1.36 to 2.72..............  .................  Growing turkeys: For    Feed continuously as           016592
                                                    the prevention of       sole ration.
                                                    coccidiosis caused by   Withdraw 7 days
                                                    Eimeria adenoeides,     before slaughter. Do
                                                    E. meleagrimitis, and   not feed to layers
                                                    E. gallopavonis.        or water fowl.
(ii) 1.36 to 2.72.............  Bacitracin         Growing turkeys: For    Feed continuously as           016592
                                 methylenedisalic   the prevention of       sole ration.
                                 ylate, 10 to 50.   coccidiosis caused by   Withdraw 7 days
                                                    Eimeria adenoeides,     before slaughter. Do
                                                    E. meleagrimitis, and   not feed to laying
                                                    E. gallopavonis, and    chickens or water
                                                    for increased rate of   fowl.
                                                    weight gain.
(iii) 1.36 to 2.72............  Bambermycins, 2..  Growing turkeys: For    Feed continuously as           016592
                                                    the prevention of       sole ration.
                                                    coccidiosis caused by   Withdraw 7 days
                                                    Eimeria adenoeides,     before slaughter. Do
                                                    E. meleagrimitis, and   not feed to laying
                                                    E. gallopavonis, and    chickens or
                                                    for increased rate of   waterfowl.
                                                    weight gain.
----------------------------------------------------------------------------------------------------------------

    (3) Halofuginone may also be used in combination with:
    (i) Lincomycin as in Sec.  558.325.
    (ii) [Reserved]

0
82. In Sec.  558.311, redesignate paragraphs (e)(5)(ii) through (v) as 
paragraphs (e)(5)(iii) and (vi), and add new paragraph (e)(5)(ii) to 
read as follows:

Sec.  558.311  Lasalocid.

* * * * *
    (e) * * *
    (5) * * *
    (ii) Lincomycin as in Sec.  558.325.
* * * * *

0
83. In Sec.  558.325, add paragraph (e)(1)(vi) to read as follows:

Sec.  558.325  Lincomycin.

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

----------------------------------------------------------------------------------------------------------------
                                  Combination in
     Lincomycin grams/ton           grams/ton        Indications for use        Limitations          Sponsors
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
(vi) 2........................  Lasalocid, 68 to   Broiler chickens: For   Feed as the sole               054771
                                 113.               the control of          ration. Type C feed
                                                    necrotic enteritis      must be used within
                                                    caused or complicated   4 weeks of
                                                    by Clostridium spp.     manufacture. Not for
                                                    or other organisms      use in laying hens,
                                                    susceptible to          breeding chickens,
                                                    lincomycin, and for     or turkeys. Do not
                                                    the prevention of       allow rabbits,
                                                    coccidiosis caused by   hamsters, guinea
                                                    Eimeria tenella, E.     pigs, horses, or
                                                    necatrix, E.            ruminants access to
                                                    acervulina, E.          feeds containing
                                                    brunetti, E. mivati,    lincomycin.
                                                    and E maxima.           Ingestion by these
                                                                            species may result
                                                                            in severe
                                                                            gastrointestinal
                                                                            effects. Lasalocid
                                                                            as provided by No.
                                                                            054771 in Sec.
                                                                            510.600 of this
                                                                            chapter.
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *

0
84. In Sec.  558.355, revise paragraph (b), add paragraph (c), and 
revise paragraph (f) to read as follows:

Sec.  558.355  Monensin.

* * * * *
    (b) Sponsor. See No. 058198 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec.  556.420 of this chapter.
* * * * *
    (f) Conditions of use. It is used as follows:
    (1) Chickens--

----------------------------------------------------------------------------------------------------------------
                                  Combination in
     Monensin in grams/ton          grams/ton        Indications for use        Limitations           Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 90 to 110.................  .................  Broiler chickens: As    Feed continuously as           058198
                                                    an aid in the           the sole ration. In
                                                    prevention of           the absence of
                                                    coccidiosis caused by   coccidiosis, the use
                                                    E. necatrix, E.         of monensin with no
                                                    tenella, E.             withdrawal period
                                                    acervulina, E.          may limit feed
                                                    brunetti, E. mivati,    intake resulting in
                                                    and E. maxima.          reduced weight gain.
                                                                            Do not feed to
                                                                            laying chickens.
(ii) 90 to 110................  .................  Replacement chickens    Feed continuously as           058198
                                                    intended for use as     the sole ration. Do
                                                    cage layers: As an      not feed to chickens
                                                    aid in the prevention   over 16 weeks of
                                                    of coccidiosis caused   age. Do not feed to
                                                    by E. necatrix, E.      laying chickens.
                                                    tenella, E.
                                                    acervulina, E.
                                                    brunetti, E. mivati,
                                                    and E. maxima.

[[Page 8977]]

 
(iii) 90 to 110...............  Bacitracin         Broiler chickens: As    Feed continuously as           054771
                                 methylenedisalic   an aid in the           sole ration. In the
                                 ylate, 4 to 50.    prevention of           absence of
                                                    coccidiosis caused by   coccidiosis, the use
                                                    E. necatrix, E.         of monensin with no
                                                    tenella, E.             withdrawal period
                                                    acervulina, E.          may limit feed
                                                    brunetti, E. mivati,    intake resulting in
                                                    and E. maxima, and      reduced weight gain.
                                                    for improved feed       Do not feed to
                                                    efficiency.             laying chickens.
                                                                            Bacitracin
                                                                            methylenedisalicylat
                                                                            e provided by No.
                                                                            054771 in Sec.
                                                                            510.600(c) of this
                                                                            chapter.
(iv) 90 to 110................  Bacitracin         Replacement chickens    Feed continuously as           054771
                                 methylenedisalic   intended for use as     sole ration. Do not
                                 ylate, 4 to 50.    cage layers: As an      feed to chickens
                                                    aid in the prevention   over 16 weeks of
                                                    of coccidiosis caused   age. Do not feed to
                                                    by E. necatrix, E.      laying chickens.
                                                    tenella, E.             Monensin sodium
                                                    acervulina, E.          provided by No.
                                                    brunetti, E. mivati,    058198, bacitracin
                                                    and E. maxima, and      methylenedisalicylat
                                                    for increased rate of   e provided by No.
                                                    weight gain and         054771 in Sec.
                                                    improved feed           510.600(c) of this
                                                    efficiency.             chapter.
(v) 90 to 110.................  Bacitracin         Broiler chickens: As    Feed continuously as           058198
                                 methylenedisalic   an aid in the           sole ration. In the
                                 ylate, 5 to 25.    prevention of           absence of
                                                    coccidiosis caused by   coccidiosis, the use
                                                    E. necatrix, E.         of monensin with no
                                                    tenella, E.             withdrawal period
                                                    acervulina, E.          may limit feed
                                                    brunetti, E. mivati,    intake resulting in
                                                    and E. maxima, and      reduced weight gain.
                                                    for increased rate of   Do not feed to
                                                    weight gain and         laying chickens.
                                                    improved feed           Bacitracin
                                                    efficiency.             methylenedisalicylat
                                                                            e provided by No.
                                                                            054771 in Sec.
                                                                            510.600(c) of this
                                                                            chapter.
(vi) 90 to 110................  Bacitracin         Broiler and             Feed continuously as           054771
                                 methylenedisalic   replacement chickens    sole ration. Do not
                                 ylate, 50.         intended for use as     feed to chickens
                                                    cage layers: As an      over 16 weeks of
                                                    aid in the prevention   age. Do not feed to
                                                    of coccidiosis caused   laying chickens.
                                                    by E. necatrix, E.      Monensin sodium
                                                    tenella, E.             provided by No.
                                                    acervulina, E.          058198, bacitracin
                                                    brunetti, E. mivati,    methylenedisalicylat
                                                    and E. maxima, and      e provided by No.
                                                    for improved feed       054771 in Sec.
                                                    efficiency, and as an   510.600(c) of this
                                                    aid in the prevention   chapter.
                                                    of necrotic enteritis
                                                    caused or complicated
                                                    by Clostridium spp.
                                                    or other organisms
                                                    susceptible to
                                                    bacitracin.
(vii) 90 to 110...............  Bacitracin zinc,   Broiler chickens: As    Feed continuously as           054771
                                 4 to 50.           an aid in the           sole ration. In the
                                                    prevention of           absence of
                                                    coccidiosis caused by   coccidiosis, the use
                                                    E. necatrix, E.         of monensin with no
                                                    tenella, E.             withdrawal period
                                                    acervulina, E.          may limit feed
                                                    brunetti, E. mivati,    intake resulting in
                                                    and E. maxima, and      reduced weight gain.
                                                    for increased rate of   Do not feed to
                                                    weight gain and         laying chickens.
                                                    improved feed           Bacitracin zinc
                                                    efficiency.             provided by No.
                                                                            054771 in Sec.
                                                                            510.600(c) of this
                                                                            chapter.
(viii) 90 to 110..............  Bacitracin zinc,   Broiler chickens: As    Feed continuously as           058198
                                 10.                an aid in the           sole ration. In the
                                                    prevention of           absence of
                                                    coccidiosis caused by   coccidiosis, the use
                                                    E. necatrix, E.         of monensin with no
                                                    tenella, E.             withdrawal period
                                                    acervulina, E.          may limit feed
                                                    brunetti, E. mivati,    intake resulting in
                                                    and E. maxima, and      reduced weight gain.
                                                    for increased rate of   Do not feed to
                                                    weight gain and         laying chickens.
                                                    improved feed           Bacitracin zinc
                                                    efficiency.             provided by No.
                                                                            054771 in Sec.
                                                                            510.600(c) of this
                                                                            chapter.
(ix) 90 to 110................  Bacitracin zinc,   Broiler chickens: As    Feed continuously as           058198
                                 10 to 30.          an aid in the           sole ration. In the
                                                    prevention of           absence of
                                                    coccidiosis caused by   coccidiosis, the use
                                                    E. necatrix, E.         of monensin with no
                                                    tenella, E.             withdrawal period
                                                    acervulina, E.          may limit feed
                                                    brunetti, E. mivati,    intake resulting in
                                                    and E. maxima, and      reduced weight gain.
                                                    for improved feed       Do not feed to
                                                    efficiency.             laying chickens.
                                                                            Bacitracin zinc
                                                                            provided by No.
                                                                            054771 in Sec.
                                                                            510.600(c) of this
                                                                            chapter.
(x) 90 to 110.................  Bambermycins, 1    Broiler chickens: As    Feed continuously as   016592, 058198
                                 to 2.              an aid in the           sole ration. Do not
                                                    prevention of           feed to laying
                                                    coccidiosis caused by   chickens.
                                                    E. necatrix, E.         Bambermycins
                                                    tenella, E.             provided by No.
                                                    acervulina, E.          016592 in Sec.
                                                    brunetti, E. mivati,    510.600(c) of this
                                                    and E. maxima, and      chapter.
                                                    for increased rate of
                                                    weight gain and
                                                    improved feed
                                                    efficiency.
----------------------------------------------------------------------------------------------------------------

    (2) Turkeys--

[[Page 8978]]

----------------------------------------------------------------------------------------------------------------
                                  Combination in
     Monensin in grams/ton          grams/ton        Indications for use        Limitations           Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 54 to 90..................  .................  Growing turkeys: For    For growing turkeys            058198
                                                    the prevention of       only. Feed
                                                    coccidiosis caused by   continuously as sole
                                                    E. adenoeides, E.       ration. Some strains
                                                    meleagrimitis, and E.   of turkey coccidia
                                                    gallopavonis.           may be monensin
                                                                            tolerant or
                                                                            resistant. Monensin
                                                                            may interfere with
                                                                            development of
                                                                            immunity to turkey
                                                                            coccidiosis. Do not
                                                                            allow horses, other
                                                                            equines, mature
                                                                            turkeys, or guinea
                                                                            fowl access to feed
                                                                            containing monensin.
                                                                            Ingestion of
                                                                            monensin by horses
                                                                            and guinea fowl has
                                                                            been fatal.
(ii) 54 to 90.................  Bacitracin         Growing turkeys: For    For growing turkeys            058198
                                 methylenedisalic   the prevention of       only. Feed
                                 ylate, 4 to 50.    coccidiosis caused by   continuously as sole
                                                    E. adenoeides, E.       ration. Some strains
                                                    meleagrimitis, and E.   of turkey coccidia
                                                    gallopavonis, and for   may be monensin
                                                    increased rate of       tolerant or
                                                    weight gain and         resistant. Monensin
                                                    improved feed           may interfere with
                                                    efficiency.             development of
                                                                            immunity to turkey
                                                                            coccidiosis. Do not
                                                                            allow horses, other
                                                                            equines, mature
                                                                            turkeys, or guinea
                                                                            fowl access to feed
                                                                            containing monensin.
                                                                            Ingestion of
                                                                            monensin by horses
                                                                            and guinea fowl has
                                                                            been fatal.
                                                                            Bacitracin
                                                                            methylenedisalicylat
                                                                            e as provided by No.
                                                                            054771 in Sec.
                                                                            510.600(c) of this
                                                                            chapter.
(iii) 54 to 90................  Bacitracin         Growing turkeys: For    For growing turkeys            058198
                                 methylenedisalic   the prevention of       only. Feed
                                 ylate, 200.        coccidiosis caused by   continuously as sole
                                                    E. adenoeides, E.       ration. Some strains
                                                    meleagrimitis, and E.   of turkey coccidia
                                                    gallopavonis, and as    may be monensin
                                                    an aid in the control   tolerant or
                                                    of transmissible        resistant. Monensin
                                                    enteritis complicated   may interfere with
                                                    by organisms            development of
                                                    susceptible to          immunity to turkey
                                                    bacitracin              coccidiosis. Do not
                                                    methylenedisalicylate.  allow horses, other
                                                                            equines, mature
                                                                            turkeys, or guinea
                                                                            fowl access to feed
                                                                            containing monensin.
                                                                            Ingestion of
                                                                            monensin by horses
                                                                            and guinea fowl has
                                                                            been fatal.
                                                                            Bacitracin
                                                                            methylenedisalicylat
                                                                            e as provided by No.
                                                                            054771 in Sec.
                                                                            510.600(c) of this
                                                                            chapter.
(iv) 54 to 90.................  Bambermycins, 1    Growing turkeys: For    For growing turkeys            058198
                                 to 2.              the prevention of       only. Feed
                                                    coccidiosis in          continuously as sole
                                                    turkeys caused by E.    ration. Some strains
                                                    adenoeides, E.          of turkey coccidia
                                                    meleagrimitis, and E.   may be monensin
                                                    gallopavonis, and for   tolerant or
                                                    improved feed           resistant. Monensin
                                                    efficiency.             may interfere with
                                                                            development of
                                                                            immunity to turkey
                                                                            coccidiosis.
                                                                            Bambermycins as
                                                                            provided by No.
                                                                            016592 in Sec.
                                                                            510.600(c) of this
                                                                            chapter.
(v) 54 to 90..................  Bambermycins, 2..  Growing turkeys: For    For growing turkeys            058198
                                                    the prevention of       only. Feed
                                                    coccidiosis caused by   continuously as sole
                                                    E. adenoeides, E.       ration. Some strains
                                                    meleagrimitis, and E.   of turkey coccidia
                                                    gallopavonis, and for   may be monensin
                                                    increased rate of       tolerant or
                                                    weight gain and         resistant. Monensin
                                                    improved feed           may interfere with
                                                    efficiency.             development of
                                                                            immunity to turkey
                                                                            coccidiosis.
                                                                            Bambermycins as
                                                                            provided by No.
                                                                            016592 in Sec.
                                                                            510.600(c) of this
                                                                            chapter.
----------------------------------------------------------------------------------------------------------------

    (3) Cattle--

----------------------------------------------------------------------------------------------------------------
        Monensin in grams/ton              Indications for use               Limitations              Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 5 to 40.........................  Cattle fed in confinement     Feed continuously in                  058198
                                       for slaughter: For improved   complete feed at a rate of
                                       feed efficiency.              50 to 480 milligrams of
                                                                     monensin per head per day.
                                                                     No additional improvement
                                                                     in feed efficiency has been
                                                                     shown from feeding monensin
                                                                     at levels greater than 30
                                                                     grams per ton (360
                                                                     milligrams per head per
                                                                     day).
(ii) 10 to 40.......................  Cattle fed in confinement     Feed at a rate of 0.14 to             058198
                                       for slaughter: For            0.42 milligram per pound of
                                       prevention and control of     body weight per day,
                                       coccidiosis due to E. bovis   depending upon the severity
                                       and E. zuernii.               of challenge, up to maximum
                                                                     of 480 milligrams per head
                                                                     per day.

[[Page 8979]]

 
(iii) 10 to 200.....................  Calves excluding veal         Feed at a rate of 0.14 to             058198
                                       calves: For prevention and    1.0 milligram monensin per
                                       control of coccidiosis due    pound of body weight per
                                       to E. bovis and E. zuernii.   day, depending upon the
                                                                     severity of challenge, up
                                                                     to maximum of 200
                                                                     milligrams per head per day.
(iv) 11 to 22.......................  Dairy cows: For increased     Feed continuously to dry and          058198
                                       milk production efficiency    lactating dairy cows in a
                                       (production of marketable     total mixed ration
                                       solids-corrected milk per     (``complete feed''). See
                                       unit of feed intake).         special labeling
                                                                     considerations in paragraph
                                                                     (d) of this section.
(v) 11 to 400.......................  Dairy cows: For increased     Feed continuously to dry and          058198
                                       milk production efficiency    lactating dairy cows in a
                                       (production of marketable     component feeding system
                                       solids-corrected milk per     (including top dress). The
                                       unit of feed intake).         Type C medicated feed must
                                                                     be fed in a minimum of 1 lb
                                                                     of feed to provide 185 to
                                                                     660 mg/head/day monensin to
                                                                     lactating cows or 115 to
                                                                     410 mg/head/day monensin to
                                                                     dry cows. See special
                                                                     labeling considerations in
                                                                     paragraph (d) of this
                                                                     section.
(vi) 15 to 400......................  Growing cattle on pasture or  For increased rate of weight          058198
                                       in dry lot (stocker and       gain, feed at a rate of 50
                                       feeder cattle and dairy and   to 200 milligrams monensin
                                       beef replacement heifers):    per head per day in not
                                       For increased rate of         less than 1 pound of feed
                                       weight gain, and for          or, after the 5th day, feed
                                       prevention and control of     at a rate of 400 milligrams
                                       coccidiosis due to E. bovis   per head per day every
                                       and E. zuernii.               other day in not less than
                                                                     2 pounds of feed. For
                                                                     prevention and control of
                                                                     coccidiosis, feed at a rate
                                                                     of 0.14 to 0.42 milligram
                                                                     per pound of body weight
                                                                     per day, depending on
                                                                     severity of challenge, up
                                                                     to 200 milligrams per head
                                                                     per day. During first 5
                                                                     days of feeding, cattle
                                                                     should receive no more than
                                                                     100 milligrams per day in
                                                                     not less than 1 pound of
                                                                     feed.
(vii) 25 to 400.....................  For improved feed             Feed to mature reproducing            058198
                                       efficiency, and for           beef cows. Feed as
                                       prevention and control of     supplemental feed, either
                                       coccidiosis due to E. bovis   hand-fed in a minimum of 1
                                       and E. zuernii.               pound of feed or mixed in a
                                                                     total ration. For improved
                                                                     feed efficiency, feed
                                                                     continuously at a rate of
                                                                     50 to 200 milligrams
                                                                     monensin per head per day.
                                                                     For prevention and control
                                                                     of coccidiosis, feed at a
                                                                     rate of 0.14 to 0.42
                                                                     milligram per pound of body
                                                                     weight per day, depending
                                                                     upon severity of challenge,
                                                                     up to a maximum of 200
                                                                     milligrams per head per
                                                                     day. During first 5 days of
                                                                     feeding, cattle should
                                                                     receive no more than 100
                                                                     milligrams per head per day.
----------------------------------------------------------------------------------------------------------------

    (4) Free-choice cattle feeds--

----------------------------------------------------------------------------------------------------------------
          Monensin  amount                 Indications for use               Limitations              Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 150 milligrams per pound of       Pasture cattle (slaughter,    Provide 50 to 200 milligrams          058198
 protein-mineral block (0.033%).       stocker, feeder, and dairy    of monensin (0.34 to 1.33
                                       and beef replacement          pounds of block) per head
                                       heifers): For increased       per day, at least 1 block
                                       rate of weight gain, and      per 10 to 12 head of
                                       for prevention and control    cattle. Roughage must be
                                       of coccidiosis caused by E.   available at all times. Do
                                       bovis and E. zuernii in       not allow animals access to
                                       pasture cattle which may      other protein blocks, salt
                                       require supplemental feed.    or mineral, while being fed
                                                                     this product. The
                                                                     effectiveness of this block
                                                                     in cull cows and bulls has
                                                                     not been established. See
                                                                     paragraph (d)(10)(i) of
                                                                     this section.
(ii) 175 milligrams per pound of      Pasture cattle (slaughter,    Provide 40 to 200 milligrams          017800
 protein-mineral block (0.038%).       stocker, and feeder): For     of monensin (0.25 to 1.13
                                       increased rate of weight      pounds or 4 to 18 ounces of
                                       gain.                         block) per head per day, at
                                                                     least 1 block per 4 head of
                                                                     cattle. Do not allow cattle
                                                                     access to salt or mineral
                                                                     while being fed this
                                                                     product. Ingestion by
                                                                     cattle of monensin at
                                                                     levels of 600 milligrams
                                                                     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.
(iii) 400 milligrams per pound of     Pasture cattle (slaughter,    Provide 80 to 200 milligrams          067949
 protein-mineral block (0.088%).       stocker, feeder, and dairy    of monensin (0.2 to 0.5
                                       and beef replacement          pounds of block) per head
                                       heifers): For increased       per day, at least 1 block
                                       rate of weight gain.          per 5 head of cattle. Feed
                                                                     blocks continuously. Do not
                                                                     feed salt or minerals
                                                                     containing salt. The
                                                                     effectiveness of this block
                                                                     in cull cows and bulls has
                                                                     not been established. See
                                                                     paragraph (d)(10)(i) of
                                                                     this section.

[[Page 8980]]

 
(iv) 400 milligrams per pound of      Pasture cattle (slaughter,    Provide 50 to 200 milligrams          051267
 block (0.088%).                       stocker, feeder, and dairy    of monensin (2 to 8 ounces
                                       and beef replacement          of block) per head per day,
                                       heifers): For increased       at least 1 block per 5 head
                                       rate of weight gain.          of cattle. Feed blocks
                                                                     continuously. Do not feed
                                                                     salt or mineral supplements
                                                                     in addition to the blocks.
                                                                     Ingestion by cattle of
                                                                     monensin at levels of 600
                                                                     milligrams 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.
(v) In free-choice Type C medicated   Growing cattle on pasture or  During the first 5 days of            058198
 feeds to provide 50 to 200 mg per     in dry lot (stocker and       feeding, cattle should
 head per day.                         feeder cattle and dairy and   receive no more than 100
                                       beef replacement heifers):    milligrams per day. Do not
                                       For increased rate of         feed additional salt or
                                       weight gain; for prevention   minerals. Do not mix with
                                       and control of coccidiosis    grain or other feeds.
                                       due to E. bovis and E.        Monensin is toxic to cattle
                                       zuernii.                      when consumed at higher
                                                                     than approved levels.
                                                                     Stressed and/or feed- and/
                                                                     or water-deprived cattle
                                                                     should be adapted to the
                                                                     pasture and to unmedicated
                                                                     supplement before using the
                                                                     monensin medicated
                                                                     supplement. The product's
                                                                     effectiveness in cull cows
                                                                     and bulls has not been
                                                                     established. See paragraph
                                                                     (d) of this section for
                                                                     other required label
                                                                     warnings.
(vi) 1,620 grams per ton of mineral   Growing cattle on pasture or  Feed at a rate of 50 to 200           058198
 granules as specified in paragraph    in dry lot (stocker and       milligrams per head per
 (f)(4)(vi)(A) of this section.        feeder cattle and dairy and   day. During the first 5
                                       beef replacement heifers):    days of feeding, cattle
                                       For increased rate of         should receive no more than
                                       weight gain, and for          100 milligrams per day. Do
                                       prevention and control of     not feed additional salt or
                                       coccidiosis due to E. bovis   minerals. Do not mix with
                                       and E. zuernii.               grain or other feeds.
                                                                     Monensin is toxic to cattle
                                                                     when consumed at higher
                                                                     than approved levels.
                                                                     Stressed and/or feed- and/
                                                                     or water-deprived cattle
                                                                     should be adapted to the
                                                                     pasture and to unmedicated
                                                                     mineral supplement before
                                                                     using the monensin mineral
                                                                     supplement. The product's
                                                                     effectiveness in cull cows
                                                                     and bulls has not been
                                                                     established.
----------------------------------------------------------------------------------------------------------------

    (A) Specifications. Use as free-choice Type C medicated feed 
formulated as mineral granules as follows:

------------------------------------------------------------------------
                                                           International
               Ingredient                     Percent        feed No.
------------------------------------------------------------------------
Monocalcium phosphate (21% phosphorus,             29.49        6-01-082
 15% calcium)...........................
Sodium chloride (salt)..................           24.37        6-04-152
Dried cane molasses.....................            20.0        4-04-695
Ground limestone (33% calcium) or                  13.75        6-02-632
 calcium carbonate (38% calcium)........
Cane molasses...........................             3.0        4-04-696
Processed grain by-products (as approved             5.0  ..............
 by AAFCO)..............................
Vitamin/trace mineral premix \1\........             2.5  ..............
Monensin Type A article, 90.7 grams per             0.89  ..............
 pound..................................
Antidusting oil.........................             1.0  ..............
------------------------------------------------------------------------
\1\ Content of vitamin and trace mineral premixes may be varied.
  However, they should be comparable to those used for other free-choice
  feeds. Formulation modifications require FDA approval prior to
  marketing. Selenium must comply with 21 CFR 573.920. Ethylenediamine
  dihydroiodide (EDDI) should comply with FDA Compliance Policy Guides
  Sec. 651.100 (CPG 7125.18).

    (B) [Reserved]
    (5) Bobwhite quail--

----------------------------------------------------------------------------------------------------------------
        Monensin in grams/ton              Indications for use               Limitations              Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 73..............................  Growing bobwhite quail: For   Feed continuously in                  058198
                                       the prevention of             complete feed at a rate of
                                       coccidiosis caused by         50 to 480 milligrams of
                                       Eimeria dispersa and E.       monensin per head per day.
                                       lettyae.                      No additional improvement
                                                                     in feed efficiency has been
                                                                     shown from feeding monensin
                                                                     at levels greater than 30
                                                                     grams per ton (360
                                                                     milligrams per head per
                                                                     day).
(ii) [Reserved].....................  ............................  ............................  ..............
----------------------------------------------------------------------------------------------------------------

[[Page 8981]]

    (6) Goats--

----------------------------------------------------------------------------------------------------------------
        Monensin in grams/ton              Indications for use               Limitations              Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 5 to 40.........................  For the prevention of         Feed only to goats being fed          058198
                                       coccidiosis caused by         in confinement. Do not feed
                                       Eimeria crandallis, E.        to lactating goats. See
                                       christenseni, and E.          paragraph (d)(13) of this
                                       ninakohlyakimovae.            section for provisions for
                                                                     monensin liquid Type C goat
                                                                     feeds.
(ii) [Reserved].....................  ............................  ............................  ..............
----------------------------------------------------------------------------------------------------------------

    (7) Monensin may also be used in combination with:
    (i) Avilamycin as in Sec.  558.68.
    (ii) Chlortetracycline as in Sec.  558.128.
    (iii) Decoquinate as in Sec.  558.195.
    (iv) Lincomycin as in Sec.  558.325.
    (v) Melengestrol acetate as in Sec.  558.342.
    (vi) Oxytetracycline as in Sec.  558.450.
    (vii) Ractopamine alone or in combination as in Sec.  558.500.
    (viii) Tilmicosin as in Sec.  558.618.
    (ix) Tylosin as in Sec.  558.625.
    (x) Virginiamycin as in Sec.  558.635.
    (xi) Zilpaterol alone or in combination as in Sec.  558.665.

0
85. In Sec.  558.364, revise paragraph (d)(1)(i) to read as follows:

Sec.  558.364  Narasin and nicarbazin.

* * * * *
    (d) * * *
    (1) * * *

----------------------------------------------------------------------------------------------------------------
  Narasin and nicarbazin in       Combination in
          grams/ton                 grams/ton        Indications for use        Limitations           Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 27 to 45 of each drug....  ...................  Broiler chickens: For  Feed continuously as           058198
                                                     prevention of          the sole ration. Do
                                                     coccidiosis caused     not feed to laying
                                                     by Eimeria tenella,    hens. Do not allow
                                                     E. necatrix, E.        adult turkeys,
                                                     acervulina, E.         horses, or other
                                                     maxima, E. brunetti,   equines access to
                                                     and E. mivati.         formulations
                                                                            containing narasin.
                                                                            Ingestion of narasin
                                                                            by these species has
                                                                            been fatal. The two
                                                                            drugs can be
                                                                            combined only at a
                                                                            1:1 ratio for the 27
                                                                            to 45 grams per ton
                                                                            range. Only granular
                                                                            nicarbazin as
                                                                            provided by No.
                                                                            058198 in Sec.
                                                                            510.600(c) of this
                                                                            chapter may be used
                                                                            in the combination.
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *

0
86. In Sec.  558.550, revise paragraph (b), add paragraph (c), revise 
paragraph (d), and add paragraph (e) to read as follows:

Sec.  558.550  Salinomycin.

* * * * *
    (b) Sponsor. See No. 016592 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec.  556.592 of this chapter.
    (d) Special considerations. Not approved for use with pellet 
binders.
    (e) Conditions of use. It is used as follows:
    (1) Chickens--

----------------------------------------------------------------------------------------------------------------
                                  Combination in
   Salinomycin in grams/ton         grams/ton        Indications for use        Limitations           Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 40 to 60..................  .................  Broiler, roaster, and   Feed continuously as           016592
                                                    replacement (breeder    sole ration. Do not
                                                    and layer) chickens:    feed to laying hens
                                                    For the prevention of   producing eggs for
                                                    coccidiosis caused by   human consumption.
                                                    Eimeria tenella, E.     May be fatal if
                                                    necatrix, E.            accidentally fed to
                                                    acervulina, E.          adult turkeys or
                                                    maxima, E. brunetti,    horses.
                                                    and E. mivati.
(ii) 40 to 60.................  Bacitracin         Broiler, roaster, and   Feed continuously as           016592
                                 methylenedisalic   replacement (breeder    sole ration. Do not           054771
                                 ylate, 4 to 50.    and layer) chickens:    feed to laying
                                                    For the prevention of   chickens. May be
                                                    coccidiosis caused by   fatal if fed to
                                                    Eimeria tenella, E.     adult turkeys or
                                                    necatrix, E.            horses. Salinomycin
                                                    acervulina, E.          as provided by No.
                                                    maxima, E. brunetti,    016592; bacitracin
                                                    and E. mivati, and      methylenedisalicylat
                                                    for increased rate of   e as provided by No.
                                                    weight gain and         054771 in Sec.
                                                    improved feed           510.600(c) of this
                                                    efficiency.             chapter.
(iii) 40 to 60................  Bacitracin         Broiler chickens: For   Feed continuously as           054771
                                 methylenedisalic   the prevention of       sole ration. Do not
                                 ylate, 50.         coccidiosis caused by   feed to laying
                                                    Eimeria tenella, E.     chickens. May be
                                                    necatrix, E.            fatal if fed to
                                                    acervulina, E.          adult turkeys or to
                                                    maxima, E. brunetti,    horses. Salinomycin
                                                    and E. mivati, and as   as provided by No.
                                                    an aid in the           016592; bacitracin
                                                    prevention of           methylenedisalicylat
                                                    necrotic enteritis      e as provided by No.
                                                    caused or complicated   054771 in Sec.
                                                    by Clostridium spp.     510.600(c) in this
                                                    or other organisms      chapter.
                                                    susceptible to
                                                    bacitracin.

[[Page 8982]]

 
(iv) 40 to 60.................  Bacitracin         Broiler chickens: For   Feed continuously as           054771
                                 methylenedisalic   the prevention of       sole ration. To
                                 ylate, 100 to      coccidiosis caused by   control necrotic
                                 200.               Eimeria tenella, E.     enteritis, start
                                                    necatrix, E.            medication at first
                                                    acervulina, E.          clinical signs of
                                                    maxima, E. brunetti,    disease; vary dosage
                                                    and E. mivati, and as   based on the
                                                    an aid in the control   severity of
                                                    of necrotic enteritis   infection;
                                                    caused or complicated   administer
                                                    by Clostridium spp.     continuously for 5
                                                    or other organisms      to 7 days or as long
                                                    susceptible to          as clinical signs
                                                    bacitracin.             persist, then reduce
                                                                            bacitracin to
                                                                            prevention level (50
                                                                            grams per ton). Do
                                                                            not feed to laying
                                                                            chickens. May be
                                                                            fatal if fed to
                                                                            adult turkeys or to
                                                                            horses. Salinomycin
                                                                            as provided by No.
                                                                            016592; bacitracin
                                                                            methylenedisalicylat
                                                                            e as provided by No.
                                                                            054771 in Sec.
                                                                            510.600(c) in this
                                                                            chapter.
(v) 40 to 60..................  Bacitracin zinc,   Broiler chickens: For   Feed continuously as           016592
                                 10 to 50.          the prevention of       sole ration. Not              054771
                                                    coccidiosis caused by   approved for use
                                                    Eimeria tenella, E.     with pellet binders.
                                                    necatrix, E.            Do not feed to
                                                    acervulina, E.          layers. May be fatal
                                                    maxima, E. brunetti,    if accidentally fed
                                                    and E. mivati, and      to adult turkeys or
                                                    for increased rate of   horses. Bacitracin
                                                    weight gain.            zinc as provided by
                                                                            No. 054771 in Sec.
                                                                            510.600(c) of this
                                                                            chapter.
(vi) 40 to 60.................  Bambermycins, 1    Broiler chickens: For   Feed continuously as           016592
                                 to 3.              the prevention of       sole ration. Do not
                                                    coccidiosis caused by   feed to laying
                                                    Eimeria tenella, E.     chickens. Not
                                                    necatrix, E.            approved for use
                                                    acervulina, E.          with pellet binders.
                                                    maxima, E. brunetti,    May be fatal if
                                                    and E. mivati, and      accidentally fed to
                                                    for improved feed       adult turkeys or
                                                    efficiency.             horses. Salinomycin
                                                                            and bambermycins as
                                                                            provided by No.
                                                                            016592 in Sec.
                                                                            510.600(c) in this
                                                                            chapter.
----------------------------------------------------------------------------------------------------------------

    (2) Game birds--

----------------------------------------------------------------------------------------------------------------
                                  Combination in
   Salinomycin in grams/ton       grams per ton      Indications for use        Limitations           Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 50........................  .................  Quail: For the          Feed continuously as   ..............
                                                    prevention of           sole ration. Not
                                                    coccidiosis caused by   approved for use
                                                    E. dispersa and E.      with pellet binders.
                                                    lettyae.                Do not feed to
                                                                            laying hens
                                                                            producing eggs for
                                                                            human consumption.
                                                                            May be fatal if
                                                                            accidentally fed to
                                                                            adult turkeys or
                                                                            horses.
(ii) [Reserved]...............  .................  ......................  .....................  ..............
----------------------------------------------------------------------------------------------------------------

    (3) Salinomycin may also be used in combination with:
    (i) Chlortetracycline as in Sec.  558.128.
    (ii) Lincomycin as in Sec.  558.325.
    (iii) Oxytetracycline as in Sec.  558.450.
    (iv) Virginiamycin as in Sec.  558.635.

0
87. In Sec.  558.625, revise paragraphs (b)(1) through (4) to read as 
follows:

Sec.  558.625  Tylosin.

* * * * *
    (b) * * *
    (1) No. 016592: Type A medicated articles containing 40 or 100 
grams per pound (g/lb).
    (2) No. 054771: Type A medicated article containing 40 g/lb.
    (3) No. 058198: Type A medicated articles containing 10, 40, or 100 
g/lb.
    (4) No. 066104: Type A medicated articles containing 20 or 40 g/lb.
* * * * *

    Dated: March 5, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-04226 Filed 3-12-19; 8:45 am]
BILLING CODE 4164-01-P