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

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Start Preamble

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.

Start Further Info

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.

End Further Info End Preamble Start Supplemental Information

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 Start Printed Page 8968in 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 dateFile No.SponsorProduct nameSpeciesEffect of the actionPublic documents
July 2, 2018200-624Modern Veterinary Therapeutics, LLC, 14343 SW 119th Ave., Miami, FL 33186REVERTIDINE (atipamezole hydrochloride) Sterile Injectable SolutionDogsOriginal approval as a generic copy of NADA 141-033FOI Summary.
July 6, 2018200-495Norbrook Laboratories, Ltd., Station Works, Newry BT35 6JP, Northern IrelandENROFLOX 100 (enrofloxacin) Injectable SolutionSwineSupplemental approval of additional indications and routes of administrationFOI Summary.
July 11, 2018138-952Elanco US Inc., 2500 Innovation Way, Greenfield, IN 46140MAXIBAN 72 (narasin and nicarbazin) Type A medicated articleChickensSupplemental approval of a revised tissue residue tolerance for nicarbazin and withdrawal period for narasin and nicarbazin Type C medicated feedsFOI Summary EA/FONSI.1
July 13, 2018200-484Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str., 1113 Sophia, BulgariaTYLOVET (tylosin phosphate) Type A medicated articlesSwine and cattleSupplemental approval of a 40 g/lb strength Type A medicated articleFOI Summary.
July 13, 2018141-406Merial, Inc., 3239 Satellite Blvd., Bldg. 500, Duluth, GA 30096-4640NEXGARD (afoxolaner) Chewable TabletsDogsSupplemental approval for the prevention of Borrelia burgdorferi infections as a direct result of killing Ixodes scapularis vector ticksFOI Summary.
July 30, 2018200-608Piedmont Animal Health, 204 Muirs Chapel Rd., Suite 200, Greensboro, NC 27410BAYTRIL (enrofloxacin) Soft Chewable TabletsDogsOriginal approval as a generic copy of NADA 140-441FOI Summary.
August 3, 2018141-461Aratana Therapeutics, Inc., 11400 Tomahawk Creek Pkwy., Leawood, KS 66211NOCITA (bupivacaine liposome injectable suspension)CatsSupplemental approval to provide for use as a peripheral nerve block to provide regional postoperative analgesia following onychectomy in catsFOI Summary.
August 8, 2018141-439Elanco US Inc., 2500 Innovation Way, Greenfield, IN 46140INTEPRITY (avilamycin) Type A medicated articleChickensSupplemental approval of a revised age restriction caution statement from 10 days to 18 days for use of avilamycin Type C medicated broiler feedsFOI Summary EA/FONSI.1
August 9, 2018200-630Aurora Pharmaceutical, LLC, 1196 Highway 3 South, Northfield, MN 55057-3009COCCIAID (amprolium) 9.6% Oral SolutionChickens and turkeysOriginal approval as a generic copy of NADA 013-149FOI Summary.
August 10, 2018141-488Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007Lincomycin and lasalocid Type C medicated feedsChickensOriginal approval for use of LINCOMIX (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 maximaFOI Summary.
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 Start Printed Page 8969list of sponsors of approved applications in § 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
011-531DIZAN (dithiazanine iodide) Tablets.
011-674DIZAN (dithiazanine iodide) Powder.
012-469DIZAN (dithiazanine iodide) Suspension with Piperazine.
031-512ATGARD (dichlorvos) Swine Wormer.
033-803TASK (dichlorvos) Dog Anthelmintic.
035-918EQUIGARD (dichlorvos).
039-483BIO-TAL (thiamylal sodium).
040-848ATGARD C (dichlorvos) Swine Wormer.
043-606ATGARD V (dichlorvos) Swine Wormer.
045-143OXIJECT (oxytetracycline hydrochloride).
047-278BIO-MYCIN (oxytetracycline hydrochloride).
047-712BIZOLIN-100 (phenylbutazone).
048-010ANAPLEX (dichlorophene and toluene) Capsules.
048-237EQUIGEL (dichlorvos).
048-271TASK (dichlorvos) Tablets.
049-032ATGARD C (dichlorvos) Premix.
055-002TEVCOCIN (chloramphenicol).
065-461ANACETIN (chloramphenicol) Tablets.
065-481Chlortetracycline Calf Scour Boluses.
065-486CTC Bisulfate (chlortetracycline bisulfate) Soluble Powder.
065-491MEDICHOL (chloramphenicol) Tablets.
092-837NEMACIDE (diethylcarbamazine citrate) Oral Syrup.
093-516BIZOLIN (phenylbutazone) Injection 20%.
094-170Phenylbutazone Tablets, U.S.P. 100 mg.
097-452OXYJECT 100 (oxytetracycline hydrochloride).
098-569MEDACIDE-SDM (sulfadimethoxine) Injection 10%.
099-618BIZOLIN (phenylbutazone) 1-gram.
108-963MEDAMYCIN (oxytetracycline hydrochloride).
117-689NEUROSYN (primidone) Tablets.
123-815Dexamethasone Sodium Phosphate Injection.
125-797Nitrofurazone Dressing.
126-236Nitrofurazone Soluble Powder.
126-676D & T (dichlorophene and toluene) Worm Capsules.
127-627NEMACIDE-C (diethylcarbamazine citrate).
128-069NEMACIDE (diethylcarbamazine citrate) Chewable Tablets.
132-028ANESTATAL (thiamylal sodium).
135-771Methylprednisolene Tablets.
136-212Methylprednisolone Acetate Injection.
137-310Gentamicin Sulfate Injectable Solution.
138-869Triamcinolone Acetonide Suspension.
140-442Xylazine Hydrochloride Injection.
141-245TRIBUTAME (chloroquine phosphate, embutramid, lidocaine) Euthanasia Solution.
200-023Gentamicin Sulfate Solution 100 mg/mL.
200-029Ketamine Hydrochloride Injection.
200-165SDM Sulfadimethoxine Concentrated Solution 12.5%.
200-178Amikacin Sulfate Injection.
200-193Clindamycin Hydrochloride Oral Liquid.
200-248Pyrantel Pamoate Suspension.
200-265Praziquantel Tablets.
200-287GBC (gentamicin sulfate, betamethasone valerate, clotrimazole) Ointment.
200-297Ivermectin Chewable Tablets.
200-298Clindamycin Hydrochloride Capsules.
200-365ROBINUL (glycopyrrolate) Injection.
200-382Furosemide 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 § 510.600(c). As a new sponsor of approved applications, Cronus Pharma Specialities India Private Ltd. will be added to § 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:Start Printed Page 8970

File No.Product name21 CFR section
010-092GALLIMYCIN-100P (erythromycin thiocyanate) Type A Medicated Article558.248.
010-346COMBUTHAL (pentobarbital sodium and thiopental sodium) Powder522.2444b.
012-123GALLIMYCIN-100 (erythromycin ) Injectable522.820.
035-157GALLIMYCIN PFC (erythromycin phosphate) Powder520.823.
035-455GALLIMYCIN-36 (erythromycin) Dry Cow Intramammary Infusion526.820.
035-456GALLIMYCIN-36 (erythromycin) Sterile Intramammary Infusion526.820.
038-661SPECTOGARD (spectinomycin) Water Soluble Powder520.2123b.
044-756BUTATRON (phenylbutazone) Tablets520.1720a.
046-780PHEN-BUTA (phenylbutazone) Vet Injection522.1720.
049-187PHEN-BUTA (phenylbutazone) Vet Tablets520.1720a.
055-059VICETRON (chloramphenicol) Tablets520.390a.
065-383UNIBIOTIC (penicillin G procaine) Intramammary Infusion526.1696a.
065-505PRO-PEN-G (penicillin G procaine) Injectable Suspension522.1696b.
065-506COMBI-PEN-48 (penicillin G benzathine and penicillin G procaine) Injectable Suspension522.1696a.
092-150PURINA (pyrantel tartrate) Horse & Colt Wormer Pellets520.2046.
093-515SPECTAM (spectinomycin) Tablets520.2123a.
095-218DEXIUM (dexamethasone) Tablets520.540b.
096-671PHEN-BUTA-Vet (phenylbutazone) Injection522.1720.
096-672PHEN-BUTA (phenylbutazone) Vet Tablets520.1720a.
098-288PREDNIS-A-Vet (prednisolone sodium phosphate) Injection522.1883.
099-169Oxytocin Injection522.1680.
099-604DEX-A-VET (dexamethasone) Injection522.540.
099-605DEX-A-VET (dexamethasone) Injection522.540.
099-606DEXAMETH-A-Vet (dexamethasone ) Injection522.540.
099-607DEXAMETH-A-Vet (dexamethasone) Injection522.540.
101-690ERYTHRO-100 (erythromycin) Injection522.820.
107-506CARBAM (diethylcarbamazine citrate) Tablets520.622a.
109-305Oxytocin Injection522.1680.
118-032PALATABS (diethylcarbamazine citrate) Tablets520.622a.
118-550FUROS-A-Vet (furosemide)522.1010.
118-979BUTATRON (phenylbutazone) Gel520.1720d.
119-141TRANQUAZINE (promazine hydrochloride) Injection522.1962.
120-615SUSTAIN III (sulfamethazine) Bolus520.2260b.
122-447FURA-SEPTIN (Nitrofurazone) Soluble Dressing524.1580a.
124-241PVL Oxytocin Injection522.1680.
126-504Nitrofurazone Ointment524.1580a.
130-136Oxytocin Injection522.1680.
138-405Pyrilamine Maleate Injection522.2063.
140-582Oxytetracycline Hydrochloride Injection522.1662a.
140-583ACTH (adrenocorticotropic hormone) Gel522.480.
141-420TILDREN (tiludronate disodium) Powder for Injection522.2473.
200-050NEOMED (neomycin sulfate) Soluble Powder520.1484.
200-069FERTELIN (gonadorelin diacetate tetrahydrate)522.1077.
200-103PENAQUA Sol-G (penicillin G potassium, USP) Soluble Powder520.1696b.
200-115GENTAMEX 100 (gentamicicn sulfate)529.1044a.
200-117OXYSHOT-LA (oxytetracycline) Injectable Solution522.1660a.
200-144TETROXY HCA-280 (oxytetracycline hydrochloride) Soluble Powder520.1660d.
200-146TETROXY 25 (oxytetracycline hydrochloride) Soluble Powder520.1660d.
200-176PRAZITECH (praziquantel) Injection522.1870.
200-247TETROXY 343 (oxytetracycline hydrochloride) Soluble Powder520.1660d.
200-253PROSTAMATE (dinoprost tromethamine) Injectable Solution522.690.
200-312DEXIUM (dexamethasone) Injection522.540.
200-313LEVAMED (levamisole hydrochloride) Soluble Powder520.1242a.
200-317DEXIUM-SP (dexamethasone sodium phosphate) Injection522.540.
200-318BIMECTIN (ivermectin) Pour-On524.1193.
200-326BIMECTIN (ivermectin) Paste520.1192.
200-328Oxytocin Injection522.1680.
200-350EXODUS (pyrantel pamoate) Paste520.2044.
200-364SPECTOGARD SCOUR-CHEK (spectinomycin dihydrochloride pentahydrate) Oral Solution520.2123c.
200-368LINCOMED 100 (lincomycin hydrochloride) Injectable Solution522.1260.
200-374TETRAMED 324 HCA (tetracycline hydrochloride) Soluble Powder520.2345d.
200-376SULFAMED-G (sulfadimethoxine) Soluble Powder520.2220a.
200-377LINXMED-SP (lincomycin hydrochloride) Soluble Powder520.1263c.
200-380SPECLINX-50 (lincomycin hydrochloride monohydrate and spectinomycin dihydrochloride pentahydrate) Soluble Powder520.1265.
200-386LEVAMED (levamisole hydrochloride) Soluble Drench Powder520.1242a.
200-387FLUNAZINE (flunixin meglumine) Injection522.970.
200-391Griseofulvin Powder520.1100.
200-434SMZ-Med 454 (sodium sulfamethazine) Soluble Powder520.2261b.
200-447BIMECTIN (ivermectin) Injection for Cattle and Swine522.1192.
200-455BILOVET (tylosin tartrate) Soluble Powder520.2640.
200-460TETROXY (oxytetracycline hydrochloride) Aquatic529.1660.
200-464AMPROMED (amprolium) For Cattle520.100.
Start Printed Page 8971
200-468GENTAMED-P (gentamicin sulfate) for Poultry Injection522.1044.
200-481OVAMED (altrenogest) Solution520.48.
200-482AMPROMED (amprolium) for Calves520.100.
200-488AMPROMED P (amprolium) for Poultry520.100.
200-489FLUNAZINE-S (flunixin meglumine) Injection522.970.
200-494GENTAMED (gentamicin sulfate) Soluble Powder520.1044c.
200-496AMPROMED P (amprolium) for Poultry520.100.
200-501Praziquantel Injection522.1870.
200-508BILOVET (tylosin) Injectable Solution522.2640.
200-523SULFAMED (sulfadimethoxine) Injection522.2220.
200-529XYLAMED (xylazine) Injection522.2662.
200-538CLINDAMED (clindamycin) Oral Drops520.447.
200-581FLUNAZINE (flunixin meglumine) Paste520.970.

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 § 510.600(c) (21 CFR 510.600(c)). As a new sponsor of approved applications, Bimeda Animal Health Ltd. will be added to § 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.”

Start List of Subjects

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
End List of Subjects

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:

Start Part

PART 510—NEW ANIMAL DRUGS

End Part Start Amendment Part

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

End Amendment Part Start Authority

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

End Authority Start Amendment Part

2. In § 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”.

End Amendment Part

The additions and revisions read as follows:

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

(c) * * *

(1) * * *

Firm name and addressDrug labeler code
*         *         *         *         *         *         *
Bimeda Animal Health Ltd., 1B The Herbert Building, The Park, Carrickmines, Dublin 18, Ireland061133
Start Printed Page 8972
*         *         *         *         *         *         *
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, India069043
*         *         *         *         *         *         *

(2) * * *

Drug labeler codeFirm name and address
*         *         *         *         *         *         *
061133Bimeda Animal Health Ltd., 1B The Herbert Building, The Park, Carrickmines, Dublin 18, Ireland.
*         *         *         *         *         *         *
069043Cronus 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.
*         *         *         *         *         *         *
Start Part

PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS

End Part Start Amendment Part

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

End Amendment Part Start Authority

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

End Authority Start Amendment Part

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

End Amendment Part
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.

* * * * *
[Amended]
Start Amendment Part

5. In § 520.48, in paragraph (b), remove “061623” and in its place add “061133”.

End Amendment Part
[Amended]
Start Amendment Part

6. In § 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”.

End Amendment Part
[Amended]
Start Amendment Part

7. In § 520.390a, in paragraph (b)(2)(i), remove “061623” and in its place add “061133”.

End Amendment Part
[Amended]
Start Amendment Part

8. In § 520.447, in paragraph (b), remove “061623” and in its place add “061133”.

End Amendment Part
[Amended]
Start Amendment Part

9. In § 520.540b, in paragraph (b)(2), remove “061623” and in its place add “061133”.

End Amendment Part
[Amended]
Start Amendment Part

10. In § 520.622a, in paragraph (a)(3), remove “061623” and in its place add “061133”.

End Amendment Part Start Amendment Part

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

End Amendment Part
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.

* * * * *
[Amended]
Start Amendment Part

12. In § 520.823, in paragraph (b), remove “061623” and in its place add “061133”.

End Amendment Part
[Amended]
Start Amendment Part

13. In § 520.970, in paragraph (b)(2), remove “061623” and in its place add “061133”.

End Amendment Part
[Amended]
Start Amendment Part

14. In § 520.1044c, in paragraph (b)(2), remove “061623” and in its place add “061133”.

End Amendment Part
[Amended]
Start Amendment Part

15. In § 520.1100, in paragraph (b)(2), remove “061623” and in its place add “061133”.

End Amendment Part
[Amended]
Start Amendment Part

16. In § 520.1192, in paragraph (b)(2), remove “061623” and in its place add “061133”.

End Amendment Part
[Amended]
Start Amendment Part

17. In § 520.1242a, in paragraph (b)(4), remove “059130” and in its place add “061133”.

End Amendment Part
[Amended]
Start Amendment Part

18. In § 520.1263c, in paragraph (b)(2), remove “061623” and in its place add “061133”.

End Amendment Part
[Amended]
Start Amendment Part

19. In § 520.1265, in paragraph (b)(2), remove “061623” and in its place add “061133”.

End Amendment Part
Start Printed Page 8973
[Amended]
Start Amendment Part

20. In § 520.1484, in paragraph (b)(2), remove “061623” and in its place add “061133”.

End Amendment Part
[Amended]
Start Amendment Part

21. In § 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”.

End Amendment Part
[Amended]
Start Amendment Part

22. In § 520.1696b, in paragraph (b), remove “061623” and in its place add “061133”.

End Amendment Part
[Amended]
Start Amendment Part

23. In § 520.1720a, in paragraph (b)(3), remove “061623” and in its place add “061133”.

End Amendment Part
[Amended]
Start Amendment Part

24. In § 520.1720d, in paragraph (b), remove “061623” and in its place add “061133”.

End Amendment Part
[Amended]
Start Amendment Part

25. Effective March 25, 2019, in § 520.2041, in paragraph (b), remove “066916, 017135,” and add in its place “017135”.

End Amendment Part
[Amended]
Start Amendment Part

26. In § 520.2044, in paragraph (b)(3), remove “061623” and in its place add “061133”.

End Amendment Part
[Amended]
Start Amendment Part

27. In § 520.2046, in paragraph (b)(2), remove “061623” and in its place add “061133”.

End Amendment Part
[Amended]
Start Amendment Part

28. In § 520.2123a, in paragraph (b), remove “061623” and in its place add “061133”.

End Amendment Part
[Amended]
Start Amendment Part

29. In § 520.2123b, in paragraph (b), remove “061623” and in its place add “061133”.

End Amendment Part
[Amended]
Start Amendment Part

30. In § 520.2123c, in paragraph (b), remove “061623” and in its place add “061133”.

End Amendment Part
[Amended]
Start Amendment Part

31. In § 520.2220a, in paragraph (b)(2), remove “061623” and in its place add “061133”.

End Amendment Part
[Amended]
Start Amendment Part

32. In § 520.2260b, in paragraphs (c)(1) and (e)(1), remove “061623” and in its place add “061133”.

End Amendment Part
[Amended]
Start Amendment Part

33. In § 520.2261b, in paragraph (b), remove “061623” and in its place add “061133”.

End Amendment Part
[Amended]
Start Amendment Part

34. In § 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”.

End Amendment Part
[Amended]
Start Amendment Part

35. In § 520.2640, in paragraph (b)(2), remove “061623” and in its place add “061133”.

End Amendment Part Start Part

PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

End Part Start Amendment Part

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

End Amendment Part Start Authority

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

End Authority
[Amended]
Start Amendment Part

37. In § 522.147, in paragraph (b), remove “No. 052483” and in its place add “Nos. 015914 and 052483”.

End Amendment Part Start Amendment Part

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

End Amendment Part
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.

[Amended]
Start Amendment Part

39. In § 522.480, in paragraph (b)(1), remove “061623” and in its place add “061133”.

End Amendment Part
[Amended]
Start Amendment Part

40. In § 522.540, in paragraphs (a)(2)(i), (b)(2), and (c)(2), remove “061623” and in its place add “061133”.

End Amendment Part
[Amended]
Start Amendment Part

41. In § 522.690, in paragraph (b)(3), remove “061623” and in its place add “061133”.

End Amendment Part Start Amendment Part

42. In § 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).

End Amendment Part

The revisions read as follows:

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.

* * * * *
[Amended]
Start Amendment Part

43. In § 522.820, in paragraph (b), remove “061623” and in its place add “061133”.

End Amendment Part
[Amended]
Start Amendment Part

44. In § 522.970, in paragraph (b)(1), remove “061623” and in its place add “061133”.

End Amendment Part
[Amended]
Start Amendment Part

45. In § 522.1010, in paragraph (b)(2), remove “061623” and in its place add “061133”.

End Amendment Part
[Amended]
Start Amendment Part

46. In § 522.1044, in paragraph (b)(4), remove “061623” and in its place add “061133”.

End Amendment Part
[Amended]
Start Amendment Part

47. In § 522.1077, in paragraph (b)(3), remove “061623” and in its place add “061133”.

End Amendment Part
Start Printed Page 8974
[Amended]
Start Amendment Part

48. In § 522.1192, in paragraph (b)(2), remove “061623” and in its place add “061133”.

End Amendment Part
[Amended]
Start Amendment Part

49. In § 522.1260, in paragraph (b)(4), remove “061623” and in its place add “061133”.

End Amendment Part
[Amended]
Start Amendment Part

50. In § 522.1660a, in paragraph (b), remove “061623” and in its place add “061133”.

End Amendment Part
[Amended]
Start Amendment Part

51. In § 522.1662a, in paragraph (k)(2), remove “061623” and in its place add “061133”.

End Amendment Part
[Amended]
Start Amendment Part

52. In § 522.1680, in paragraph (b), remove “061623” and in its place add “061133”.

End Amendment Part
[Amended]
Start Amendment Part

53. In § 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”.

End Amendment Part
[Amended]
Start Amendment Part

54. In § 522.1696b, in paragraphs (b)(2), (d)(2)(i)(A), and (d)(2)(iii)(A), remove “061623” and in its place add “061133”.

End Amendment Part
[Amended]
Start Amendment Part

55. In § 522.1720, in paragraph (b)(2), remove “061623” and in its place add “061133”.

End Amendment Part
[Amended]
Start Amendment Part

56. In § 522.1870, in paragraph (b), remove “061623” and in its place add “061133”.

End Amendment Part
[Amended]
Start Amendment Part

57. In § 522.1883, in paragraph (b), remove “061623” and in its place add “061133”.

End Amendment Part
[Amended]
Start Amendment Part

58. In § 522.1962, in paragraph (b)(2), remove “061623” and in its place add “061133”.

End Amendment Part
[Amended]
Start Amendment Part

59. In § 522.2063, in paragraph (b)(2), remove “061623” and in its place add “061133”.

End Amendment Part
[Amended]
Start Amendment Part

60. In § 522.2220, in paragraph (b)(3), remove “061623” and in its place add “061133”.

End Amendment Part
[Amended]
Start Amendment Part

61. In § 522.2444b, in paragraph (b), remove “061623” and in its place add “061133”.

End Amendment Part
[Amended]
Start Amendment Part

62. In § 522.2473, in paragraph (b), remove “061623” and in its place add “061133”.

End Amendment Part
[Amended]
Start Amendment Part

63. In § 522.2640, in paragraph (b)(2), remove “061623” and in its place add “061133”.

End Amendment Part
[Amended]
Start Amendment Part

64. In § 522.2662, in paragraph (b)(2), remove “061623” and in its place add “061133”.

End Amendment Part Start Part

PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

End Part Start Amendment Part

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

End Amendment Part Start Authority

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

End Authority
[Amended]
Start Amendment Part

66. In § 524.1193, in paragraph (b)(1), remove “061623” and in its place add “061133”.

End Amendment Part
[Amended]
Start Amendment Part

67. In § 524.1580a, in paragraph (b)(1), remove “061623” and in its place add “061133”.

End Amendment Part Start Part

PART 526—INTRAMAMMARY DOSAGE FORM NEW ANIMAL DRUGS

End Part Start Amendment Part

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

End Amendment Part Start Authority

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

End Authority
[Amended]
Start Amendment Part

69. In § 526.820, in paragraph (b), remove “061623” and in its place add “061133”.

End Amendment Part
[Amended]
Start Amendment Part

70. In § 526.1696a, in paragraph (c), remove “061623” and in its place add “061133”.

End Amendment Part Start Part

PART 529—CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

End Part Start Amendment Part

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

End Amendment Part Start Authority

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

End Authority
[Amended]
Start Amendment Part

72. In § 529.1044a, in paragraph (b), remove “061623” and in its place add “061133”.

End Amendment Part
[Amended]
Start Amendment Part

73. In § 529.1660, in paragraphs (b)(1) and (2), remove “061623” and in its place add “061133”.

End Amendment Part Start Part

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

End Part Start Amendment Part

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

End Amendment Part Start Authority

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

End Authority Start Amendment Part

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

End Amendment Part
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) ChickensLiver (target tissue): 52 ppm.

(2) [Reserved]

* * * * *
Start Part

PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

End Part Start Amendment Part

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

End Amendment Part Start Authority

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

End Authority Start Amendment Part

77. In § 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)”.

End Amendment Part

The revisions and addition read as follows:

Requirement of a medicated feed mill license.
* * * * *

(d) * * *Start Printed Page 8975

Category I

DrugAssay limits percent 1 Type AType B maximum (200x)Assay limits percent 1 Type B/C 2
*         *         *         *         *         *         *
Narasin90-1109.0 g/lb (1.98%)85-115/75-125.
Nicarbazin (granular)90-1109.0 g/lb (1.98%)85-115/75-125.
Narasin90-1109.0 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

DrugAssay limits percent 1 Type AType B maximum (100x)Assay limits percent 1 Type B/C 2
*         *         *         *         *         *         *
Nicarbazin (powder)90-1109.08 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.
* * * * *
[Amended]
Start Amendment Part

78. In § 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”.

End Amendment Part
[Amended]
Start Amendment Part

79. In § 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”.

End Amendment Part
[Amended]
Start Amendment Part

80. In § 558.248, in paragraph (b), remove “061623” and in its place add “061133”.

End Amendment Part Start Amendment Part

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

End Amendment Part
Halofuginone.
* * * * *

(b) Sponsor. See No. 016592 in § 510.600(c) of this chapter.

* * * * *

(d) Conditions of use. It is used in feed as follows:

(1) Chickens

Halofuginone in grams/tonCombination in grams/tonIndications for useLimitationsSponsor
(i) 2.72Broiler chickens: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maximaFeed continuously as sole ration. Do not feed to layers. Withdraw 4 days before slaughter016592
(ii) 2.72Bacitracin methylenedisalicylate, 10 to 50Broiler chickens: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxima; for improved feed efficiencyFeed continuously as sole ration. Do not feed to layers. Withdraw 5 days before slaughter016592
(iii) 2.72Bambermycins, 1 to 2Broiler chickens: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E, acervulina, E. brunetti, E. mivati, and E. maxima; for increased rate of weight gain and improved feed efficiencyFeed continuously as sole ration. Do not feed to layers. Withdraw 5 days before slaughter016592
(iv) 2.72Replacement broiler breeder chickens and replacement cage laying chickens: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. mivati/E. mitis, and E. brunettiFeed continuously as sole ration to replacement cage laying chickens until 20 weeks of age. Feed continuously as sole ration to replacement broiler breeder chickens until 16 weeks of age. Do not feed to laying chickens or water fowl. Withdraw 4 days before slaughter016592
Start Printed Page 8976

(2) Turkeys

Halofuginone in grams/tonCombination in grams/tonIndications for useLimitationsSponsor
(i) 1.36 to 2.72Growing turkeys: For the prevention of coccidiosis caused by Eimeria adenoeides, E. meleagrimitis, and E. gallopavonisFeed continuously as sole ration. Withdraw 7 days before slaughter. Do not feed to layers or water fowl016592
(ii) 1.36 to 2.72Bacitracin methylenedisalicylate, 10 to 50Growing turkeys: For the prevention of coccidiosis caused by Eimeria adenoeides, E. meleagrimitis, and E. gallopavonis, and for increased rate of weight gainFeed continuously as sole ration. Withdraw 7 days before slaughter. Do not feed to laying chickens or water fowl016592
(iii) 1.36 to 2.72Bambermycins, 2Growing turkeys: For the prevention of coccidiosis caused by Eimeria adenoeides, E. meleagrimitis, and E. gallopavonis, and for increased rate of weight gainFeed continuously as sole ration. Withdraw 7 days before slaughter. Do not feed to laying chickens or waterfowl016592

(3) Halofuginone may also be used in combination with:

(i) Lincomycin as in § 558.325.

(ii) [Reserved]

Start Amendment Part

82. In § 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:

End Amendment Part
Lasalocid.
* * * * *

(e) * * *

(5) * * *

(ii) Lincomycin as in § 558.325.

* * * * *
Start Amendment Part

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

End Amendment Part
Lincomycin.
* * * * *

(e) * * *

(1) * * *

Lincomycin grams/tonCombination in grams/tonIndications for useLimitationsSponsors
*         *         *         *         *         *         *
(vi) 2Lasalocid, 68 to 113Broiler chickens: 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 maximaFeed as the sole ration. Type C feed must be used within 4 weeks of manufacture. Not for use in laying hens, breeding chickens, or turkeys. Do not allow rabbits, hamsters, guinea pigs, horses, or ruminants access to feeds containing lincomycin. Ingestion by these species may result in severe gastrointestinal effects. Lasalocid as provided by No. 054771 in § 510.600 of this chapter054771
*         *         *         *         *         *         *
* * * * *
Start Amendment Part

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

End Amendment Part
Monensin.
* * * * *

(b) Sponsor. See No. 058198 in § 510.600(c) of this chapter.

(c) Related tolerances. See § 556.420 of this chapter.

* * * * *

(f) Conditions of use. It is used as follows:

(1) Chickens

Monensin in grams/tonCombination in grams/tonIndications for useLimitationsSponsor
(i) 90 to 110Broiler chickens: As an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maximaFeed continuously as the sole ration. In the absence of coccidiosis, the use of monensin with no withdrawal period may limit feed intake resulting in reduced weight gain. Do not feed to laying chickens058198
(ii) 90 to 110Replacement chickens intended for use as cage layers: As an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maximaFeed continuously as the sole ration. Do not feed to chickens over 16 weeks of age. Do not feed to laying chickens058198
Start Printed Page 8977
(iii) 90 to 110Bacitracin methylenedisalicylate, 4 to 50Broiler chickens: As an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima, and for improved feed efficiencyFeed continuously as sole ration. In the absence of coccidiosis, the use of monensin with no withdrawal period may limit feed intake resulting in reduced weight gain. Do not feed to laying chickens. Bacitracin methylenedisalicylate provided by No. 054771 in § 510.600(c) of this chapter054771
(iv) 90 to 110Bacitracin methylenedisalicylate, 4 to 50Replacement chickens intended for use as cage layers: As an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima, and for increased rate of weight gain and improved feed efficiencyFeed continuously as sole ration. Do not feed to chickens over 16 weeks of age. Do not feed to laying chickens. Monensin sodium provided by No. 058198, bacitracin methylenedisalicylate provided by No. 054771 in § 510.600(c) of this chapter054771
(v) 90 to 110Bacitracin methylenedisalicylate, 5 to 25Broiler chickens: As an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima, and for increased rate of weight gain and improved feed efficiencyFeed continuously as sole ration. In the absence of coccidiosis, the use of monensin with no withdrawal period may limit feed intake resulting in reduced weight gain. Do not feed to laying chickens. Bacitracin methylenedisalicylate provided by No. 054771 in § 510.600(c) of this chapter058198
(vi) 90 to 110Bacitracin methylenedisalicylate, 50Broiler and replacement chickens intended for use as cage layers: As an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima, and for improved feed efficiency, and as an aid in the prevention of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracinFeed continuously as sole ration. Do not feed to chickens over 16 weeks of age. Do not feed to laying chickens. Monensin sodium provided by No. 058198, bacitracin methylenedisalicylate provided by No. 054771 in § 510.600(c) of this chapter054771
(vii) 90 to 110Bacitracin zinc, 4 to 50Broiler chickens: As an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima, and for increased rate of weight gain and improved feed efficiencyFeed continuously as sole ration. In the absence of coccidiosis, the use of monensin with no withdrawal period may limit feed intake resulting in reduced weight gain. Do not feed to laying chickens. Bacitracin zinc provided by No. 054771 in § 510.600(c) of this chapter054771
(viii) 90 to 110Bacitracin zinc, 10Broiler chickens: As an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima, and for increased rate of weight gain and improved feed efficiencyFeed continuously as sole ration. In the absence of coccidiosis, the use of monensin with no withdrawal period may limit feed intake resulting in reduced weight gain. Do not feed to laying chickens. Bacitracin zinc provided by No. 054771 in § 510.600(c) of this chapter058198
(ix) 90 to 110Bacitracin zinc, 10 to 30Broiler chickens: As an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima, and for improved feed efficiencyFeed continuously as sole ration. In the absence of coccidiosis, the use of monensin with no withdrawal period may limit feed intake resulting in reduced weight gain. Do not feed to laying chickens. Bacitracin zinc provided by No. 054771 in § 510.600(c) of this chapter058198
(x) 90 to 110Bambermycins, 1 to 2Broiler chickens: As an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima, and for increased rate of weight gain and improved feed efficiencyFeed continuously as sole ration. Do not feed to laying chickens. Bambermycins provided by No. 016592 in § 510.600(c) of this chapter016592, 058198

(2) Turkeys— Start Printed Page 8978

Monensin in grams/tonCombination in grams/tonIndications for useLimitationsSponsor
(i) 54 to 90Growing turkeys: For the prevention of coccidiosis caused by E. adenoeides, E. meleagrimitis, and E. gallopavonisFor growing turkeys only. Feed continuously as sole ration. Some strains of turkey coccidia 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 fatal058198
(ii) 54 to 90Bacitracin methylenedisalicylate, 4 to 50Growing turkeys: For the prevention of coccidiosis caused by E. adenoeides, E. meleagrimitis, and E. gallopavonis, and for increased rate of weight gain and improved feed efficiencyFor growing turkeys only. Feed continuously as sole ration. Some strains of turkey coccidia 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. Bacitracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) of this chapter058198
(iii) 54 to 90Bacitracin methylenedisalicylate, 200Growing turkeys: For the prevention of coccidiosis caused by E. adenoeides, E. meleagrimitis, and E. gallopavonis, and as an aid in the control of transmissible enteritis complicated by organisms susceptible to bacitracin methylenedisalicylateFor growing turkeys only. Feed continuously as sole ration. Some strains of turkey coccidia 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. Bacitracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) of this chapter058198
(iv) 54 to 90Bambermycins, 1 to 2Growing turkeys: For the prevention of coccidiosis in turkeys caused by E. adenoeides, E. meleagrimitis, and E. gallopavonis, and for improved feed efficiencyFor growing turkeys only. Feed continuously as sole ration. Some strains of turkey coccidia may be monensin tolerant or resistant. Monensin may interfere with development of immunity to turkey coccidiosis. Bambermycins as provided by No. 016592 in § 510.600(c) of this chapter058198
(v) 54 to 90Bambermycins, 2Growing turkeys: For the prevention of coccidiosis caused by E. adenoeides, E. meleagrimitis, and E. gallopavonis, and for increased rate of weight gain and improved feed efficiencyFor growing turkeys only. Feed continuously as sole ration. Some strains of turkey coccidia may be monensin tolerant or resistant. Monensin may interfere with development of immunity to turkey coccidiosis. Bambermycins as provided by No. 016592 in § 510.600(c) of this chapter058198

(3) Cattle

Monensin in grams/tonIndications for useLimitationsSponsor
(i) 5 to 40Cattle fed in confinement for slaughter: For improved feed efficiencyFeed continuously in complete feed at a rate of 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)058198
(ii) 10 to 40Cattle fed in confinement for slaughter: For prevention and control of coccidiosis due to E. bovis and E. zuerniiFeed at a rate of 0.14 to 0.42 milligram per pound of body weight per day, depending upon the severity of challenge, up to maximum of 480 milligrams per head per day058198
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(iii) 10 to 200Calves excluding veal calves: For prevention and control of coccidiosis due to E. bovis and E. zuerniiFeed at a rate of 0.14 to 1.0 milligram monensin per pound of body weight per day, depending upon the severity of challenge, up to maximum of 200 milligrams per head per day058198
(iv) 11 to 22Dairy cows: For increased milk production efficiency (production of marketable solids-corrected milk per unit of feed intake)Feed continuously to dry and lactating dairy cows in a total mixed ration (“complete feed”). See special labeling considerations in paragraph (d) of this section058198
(v) 11 to 400Dairy cows: For increased milk production efficiency (production of marketable solids-corrected milk per unit of feed intake)Feed continuously to dry and lactating dairy cows in a component feeding system (including top dress). The 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 section058198
(vi) 15 to 400Growing cattle on pasture or in dry lot (stocker and feeder cattle and dairy and beef replacement heifers): For increased rate of weight gain, and for prevention and control of coccidiosis due to E. bovis and E. zuerniiFor increased rate of weight gain, feed at a rate of 50 to 200 milligrams monensin per head per day in not less than 1 pound of feed or, after the 5th day, feed at a rate of 400 milligrams per head per day every 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 feed058198
(vii) 25 to 400For improved feed efficiency, and for prevention and control of coccidiosis due to E. bovis and E. zuerniiFeed to mature reproducing beef cows. Feed as supplemental feed, either hand-fed in a minimum of 1 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 day058198

(4) Free-choice cattle feeds

Monensin amountIndications for useLimitationsSponsor
(i) 150 milligrams per pound of protein-mineral block (0.033%)Pasture cattle (slaughter, stocker, feeder, and dairy and beef replacement heifers): For increased rate of weight gain, and for prevention and control of coccidiosis caused by E. bovis and E. zuernii in pasture cattle which may require supplemental feedProvide 50 to 200 milligrams of monensin (0.34 to 1.33 pounds of block) per head per day, at least 1 block per 10 to 12 head of cattle. Roughage must be available at all times. Do not allow animals access to other protein blocks, salt 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 section058198
(ii) 175 milligrams per pound of protein-mineral block (0.038%)Pasture cattle (slaughter, stocker, and feeder): For increased rate of weight gainProvide 40 to 200 milligrams of monensin (0.25 to 1.13 pounds or 4 to 18 ounces of 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 section017800
(iii) 400 milligrams per pound of protein-mineral block (0.088%)Pasture cattle (slaughter, stocker, feeder, and dairy and beef replacement heifers): For increased rate of weight gainProvide 80 to 200 milligrams of monensin (0.2 to 0.5 pounds of block) per head per day, at least 1 block 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 section067949
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(iv) 400 milligrams per pound of block (0.088%)Pasture cattle (slaughter, stocker, feeder, and dairy and beef replacement heifers): For increased rate of weight gainProvide 50 to 200 milligrams of monensin (2 to 8 ounces of block) per head per day, at least 1 block per 5 head 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 section051267
(v) In free-choice Type C medicated feeds to provide 50 to 200 mg per head per dayGrowing cattle on pasture or in dry lot (stocker and feeder cattle and dairy and beef replacement heifers): For increased rate of weight gain; for prevention and control of coccidiosis due to E. bovis and E. zuerniiDuring the first 5 days of feeding, cattle should receive no more than 100 milligrams per day. Do not feed additional salt or minerals. Do not mix with 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 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 warnings058198
(vi) 1,620 grams per ton of mineral granules as specified in paragraph (f)(4)(vi)(A) of this sectionGrowing cattle on pasture or in dry lot (stocker and feeder cattle and dairy and beef replacement heifers): For increased rate of weight gain, and for prevention and control of coccidiosis due to E. bovis and E. zuerniiFeed at a rate of 50 to 200 milligrams per head per day. During the first 5 days of feeding, cattle should receive no more than 100 milligrams per day. Do not feed additional salt or minerals. Do not mix with 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 established058198

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

IngredientPercentInternational feed No.
Monocalcium phosphate (21% phosphorus, 15% calcium)29.496-01-082
Sodium chloride (salt)24.376-04-152
Dried cane molasses20.04-04-695
Ground limestone (33% calcium) or calcium carbonate (38% calcium)13.756-02-632
Cane molasses3.04-04-696
Processed grain by-products (as approved by AAFCO)5.0
Vitamin/trace mineral premix 12.5
Monensin Type A article, 90.7 grams per pound0.89
Antidusting oil1.0
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/tonIndications for useLimitationsSponsor
(i) 73Growing bobwhite quail: For the prevention of coccidiosis caused by Eimeria dispersa and E. lettyaeFeed continuously in complete feed at a rate of 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)058198
(ii) [Reserved]
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(6) Goats

Monensin in grams/tonIndications for useLimitationsSponsor
(i) 5 to 40For the prevention of coccidiosis caused by Eimeria crandallis, E. christenseni, and E. ninakohlyakimovaeFeed only to goats being fed in confinement. Do not feed to lactating goats. See paragraph (d)(13) of this section for provisions for monensin liquid Type C goat feeds058198
(ii) [Reserved]

(7) Monensin may also be used in combination with:

(i) Avilamycin as in § 558.68.

(ii) Chlortetracycline as in § 558.128.

(iii) Decoquinate as in § 558.195.

(iv) Lincomycin as in § 558.325.

(v) Melengestrol acetate as in § 558.342.

(vi) Oxytetracycline as in § 558.450.

(vii) Ractopamine alone or in combination as in § 558.500.

(viii) Tilmicosin as in § 558.618.

(ix) Tylosin as in § 558.625.

(x) Virginiamycin as in § 558.635.

(xi) Zilpaterol alone or in combination as in § 558.665.

Start Amendment Part

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

End Amendment Part
Narasin and nicarbazin.
* * * * *

(d) * * *

(1) * * *

Narasin and nicarbazin in grams/tonCombination in grams/tonIndications for useLimitationsSponsor
(i) 27 to 45 of each drugBroiler chickens: For prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivatiFeed continuously as the sole ration. Do not feed to laying hens. Do not allow adult turkeys, horses, or other equines access to 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 § 510.600(c) of this chapter may be used in the combination058198
*         *         *         *         *         *         *
* * * * *
Start Amendment Part

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

End Amendment Part
Salinomycin.
* * * * *

(b) Sponsor. See No. 016592 in § 510.600(c) of this chapter.

(c) Related tolerances. See § 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

Salinomycin in grams/tonCombination in grams/tonIndications for useLimitationsSponsor
(i) 40 to 60Broiler, roaster, and replacement (breeder and layer) chickens: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivatiFeed continuously as sole ration. Do not feed to laying hens producing eggs for human consumption. May be fatal if accidentally fed to adult turkeys or horses016592
(ii) 40 to 60Bacitracin methylenedisalicylate, 4 to 50Broiler, roaster, and replacement (breeder and layer) chickens: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, and for increased rate of weight gain and improved feed efficiencyFeed continuously as sole ration. Do not feed to laying chickens. May be fatal if fed to adult turkeys or horses. Salinomycin as provided by No. 016592; bacitracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) of this chapter016592 054771
(iii) 40 to 60Bacitracin methylenedisalicylate, 50Broiler chickens: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, and as an aid in the prevention of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracinFeed continuously as sole ration. Do not feed to laying chickens. May be fatal if fed to adult turkeys or to horses. Salinomycin as provided by No. 016592; bacitracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) in this chapter054771
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(iv) 40 to 60Bacitracin methylenedisalicylate, 100 to 200Broiler chickens: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, and as an aid in the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracinFeed continuously as sole ration. To control necrotic enteritis, start medication at first clinical signs of disease; vary dosage based on the severity of infection; administer continuously for 5 to 7 days or as long as clinical signs 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 methylenedisalicylate as provided by No. 054771 in § 510.600(c) in this chapter054771
(v) 40 to 60Bacitracin zinc, 10 to 50Broiler chickens: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, and for increased rate of weight gainFeed continuously as sole ration. Not approved for use with pellet binders. Do not feed to layers. May be fatal if accidentally fed to adult turkeys or horses. Bacitracin zinc as provided by No. 054771 in § 510.600(c) of this chapter016592 054771
(vi) 40 to 60Bambermycins, 1 to 3Broiler chickens: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, and for improved feed efficiencyFeed continuously as sole ration. Do not feed to laying chickens. Not approved for use with pellet binders. May be fatal if accidentally fed to adult turkeys or horses. Salinomycin and bambermycins as provided by No. 016592 in § 510.600(c) in this chapter016592

(2) Game birds

Salinomycin in grams/tonCombination in grams per tonIndications for useLimitationsSponsor
(i) 50Quail: For the prevention of coccidiosis caused by E. dispersa and E. lettyaeFeed continuously as sole ration. Not approved for use with pellet binders. 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 § 558.128.

(ii) Lincomycin as in § 558.325.

(iii) Oxytetracycline as in § 558.450.

(iv) Virginiamycin as in § 558.635.

Start Amendment Part

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

End Amendment Part
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.

* * * * *
Start Signature

Dated: March 5, 2019.

Lowell J. Schiller,

Acting Associate Commissioner for Policy.

End Signature End Supplemental Information

[FR Doc. 2019-04226 Filed 3-12-19; 8:45 am]

BILLING CODE 4164-01-P