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

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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 October, November, and December 2019. FDA is informing the public of the availability Start Printed Page 18115of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to make technical amendments to improve the accuracy of the regulations.

DATES:

This rule is effective March 30, 2020.

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 October, November, and December 2019, as listed in table 1. In addition, FDA is informing the public of the availability, where applicable, of documentation of environmental review required under the National Environmental Policy Act (NEPA) and, for actions requiring review of safety or effectiveness data, summaries of the basis of approval (FOI Summaries) under the Freedom of Information Act (FOIA). These public documents may be seen in the office of the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday. Persons with access to the internet may obtain these documents at the CVM FOIA Electronic Reading Room: https://www.fda.gov/​about-fda/​center-veterinary-medicine/​cvm-foia-electronic-reading-room. Marketing exclusivity and patent information may be accessed in FDA's publication, Approved Animal Drug Products Online (Green Book) at: https://www.fda.gov/​animal-veterinary/​products/​approved-animal-drug-products-green-book.

Table 1—Original and Supplemental NADAs and ANADAs Approved During October, November, and December 2019

Approval dateFile No.SponsorProduct nameSpeciesEffect of the actionPublic documents
October 11, 2019200-652Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str., 1113 Sophia, BulgariaMonensin and decoquinate Type B and Type C medicated feedsCattleOriginal approval for use of MONOVET 90 (monensin Type A medicated article) with DECCOX (decoquinate) Type A medicated articles in the manufacture of Type B and Type C medicated feeds as a generic copy of NADA 141-148FOI Summary.
October 11, 2019200-653DoMonensin, tylosin phosphate, and decoquinate Type B and Type C medicated feedsCattleOriginal approval for use of MONOVET 90 (monensin Type A medicated article) with TYLOVET (tylosin phosphate) and DECCOX (decoquinate) Type A medicated articles in the manufacture of Type B and Type C medicated feeds as a generic copy of NADA 141-149FOI Summary.
October 11, 2019200-654DoMonensin and tilmicosin phosphate Type B and Type C medicated feedsCattleOriginal approval for use of MONOVET 90 (monensin Type A medicated article) with TILMOVET (tilmicosin phosphate) Type A medicated article in the manufacture of Type B and Type C medicated feeds as a generic copy of NADA 141-343FOI Summary.
October 11, 2019200-655DoMonensin and tilmicosin phosphate Type B and Type C medicated feedsCattleOriginal approval for use of MONOVET 90 (monensin Type A medicated article) with PULMOTIL (tilmicosin phosphate) Type A medicated article in the manufacture of Type B and Type C medicated feeds as a generic copy of NADA 141-343FOI Summary.
October 11, 2019200-656DoMonensin, tylosin phosphate, and decoquinate Type B and Type C medicated feedsCattleOriginal approval for use of MONOVET 90 (monensin Type A medicated article) with TYLAN (tylosin phosphate) and DECCOX (decoquinate) Type A medicated articles in the manufacture of Type B and Type C medicated feeds as a generic copy of NADA 141-149FOI Summary.
October 11, 2019200-658DoMonensin and melengestrol acetate Type C medicated feedsCattleOriginal approval for use of MONOVET 90 (monensin Type A medicated article) with MGA (melengestrol acetate Type A medicated article) in the manufacture of Type C medicated feeds as a generic copy of NADA 125-476FOI Summary.
October 11, 2019200-659DoMonensin, ractopamine hydrochloride, and melengestrol acetate Type C medicated feedsCattleOriginal approval for use of MONOVET 90 (monensin Type A medicated article) with ACTOGAIN (ractopamine hydrochloride Type A medicated article) and MGA (melengestrol acetate Type A medicated articles) in the manufacture of Type C medicated feeds as a generic copy of NADA 141-234FOI Summary.
October 11, 2019200-660DoMonensin, tylosin phosphate, and melengestrol acetate Type C medicated feedsCattleOriginal approval for use of MONOVET 90 (monensin Type A medicated article) with TYLOVET (tylosin phosphate) Type A medicated article, and MGA (melengestrol acetate Type A medicated article) in the manufacture of Type C medicated feeds as a generic copy of NADA 138-870FOI Summary.
Start Printed Page 18116
October 11, 2019200-661DoMonensin, tylosin phosphate, and melengestrol acetate Type C medicated feedsCattleOriginal approval for use of MONOVET 90 (monensin Type A medicated article) with TYLAN (tylosin phosphate) Type A medicated article, and MGA (melengestrol acetate Type A medicated article) in the manufacture of Type C medicated feeds as a generic copy of NADA 138-870FOI Summary.
October 11, 2019200-662DoMonensin and ractopamine hydrochloride Type B and Type C medicated feedsCattleOriginal approval for use of MONOVET 90 (monensin Type A medicated article) with ACTOGAIN (ractopamine hydrochloride Type A medicated article) in the manufacture of Type B and Type C medicated feeds as a generic copy of NADA 141-225FOI Summary.
October 29, 2019200-635Mizner Bioscience LLC, 225 NE Mizner Blvd., Suite 760, Boca Raton, FL 33432Clomipramine Hydrochloride TabletsDogsOriginal approval as a generic copy of NADA 141-120FOI Summary.
November 14, 2019141-518Intervet, Inc., 2 Giralda Farms, Madison, NJ 07940BRAVECTO PLUS (fluralaner and moxidectin topical solution) SolutionCatsOriginal approval for the prevention of heartworm disease and for the treatment of infections with intestinal roundworm and hookworm; kills adult fleas and is indicated for the treatment and prevention of flea infestations, and the treatment and control of tick infestations for 2 months in cats and kittensFOI Summary.
November 20, 2019200-663Norbrook Laboratories Ltd., Station Works, County Down, Newry, BT35 6JP, UKSELARID (selamectin) Topical SolutionDogs and catsOriginal approval as a generic copy of NADA 141-152FOI Summary.
November 25, 2019141-513Kindred Biosciences, Inc., 1555 Bayshore Hwy., Suite 200, Burlingame, CA 94010ZIMETA (dipyrone injection)HorsesOriginal approval for control of pyrexia in horsesFOI Summary.
December 9, 2019141-528Elanco US Inc., 2500 Innovation Way, Greenfield, IN 46140CREDELIO CAT (lotilaner) Chewable TabletsCatsOriginal approval for killing adult fleas, and for the treatment and prevention of flea infestations for 1 month in cats and kittensFOI Summary.
December 9, 2019200-546Bimeda Animal Health Ltd., 1B The Herbert Building, The Park, Carrickmines, Dublin, 18, EIBIMAGARD 12.5% (tiamulin hydrogen fumarate) Liquid Concentrate for SwineSwineOriginal approval as a generic copy of NADA 140-916FOI Summary.
December 19, 2019200-615Vetoquinol USA, Inc., 4250 N. Sylvania Ave., Fort Worth, TX 76137IMOXI (imidacloprid and moxidectin) Topical Solution for DogsDogsOriginal approval as a generic copy of NADA 141-251FOI Summary.
December 30, 2019111-636Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007LINCOMIX (lincomycin hydrochloride) Soluble PowderHoneybeesSupplemental approval of a tolerance for residues of lincomycin in honeyFOI Summary.
December 30, 2019008-862DoTERRAMYCIN (oxytetracycline hydrochloride) Soluble PowderHoneybeesSupplemental approval of a tolerance for residues of oxytetracycline in honeyFOI Summary.
December 30, 2019013-076Elanco US Inc. 2500 Innovation Way, Greenfield, IN 46140TYLAN (tylosin tartrate) SolubleHoneybeesSupplemental approval of a tolerance for residues of tylosin in honeyFOI Summary.

II. Withdrawals of Approval

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

File No.Product name21 CFR section
055-036PRINCILLIN (ampicillin trihydrate) Capsules520.90c.
055-050PRINCILLIN (ampicillin trihydrate) Soluble Powder520.90e.
055-056PRINCILLIN (ampicillin trihydrate) Bolus520.90f.
055-061PRINCILLIN “125” For Oral Suspension520.90d.
055-068BOVICLOX (cloxacillin benzathine)526.464b.
065-013Dihydrostreptomycin (dihydrostreptomycin sulfate)522.650.
065-493JETPEN (penicillin G benzathine and penicillin G procaine) Aqueous Suspension522.1696a.
065-500TANDEM PEN (penicillin G procaine)522.1696b.
Start Printed Page 18117

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

III. Changes of Sponsor

Cooperative Research Farms, Box 69, Charlotteville, NY 12036, has informed FDA that it has transferred ownership of, and all rights and interest in, approved NADA 119-253 for Cattle Block M (monensin) a free-choice Type C medicated cattle feed to Wildcat Feeds, 215 NE Strait Ave., Topeka, KS 66616. Following this change of sponsorship, Cooperative Research Farms is no longer the sponsor of an approved application.

Dechra, Ltd., Snaygill Industrial Estate, Keighley Rd., Skipton, North Yorkshire, BD23 2RW, United Kingdom, has informed FDA that it has transferred ownership of, and all rights and interest in, approved ANADA 200-273 for VETRO-GEN Veterinary Ophthalmic Ointment to Putney, Inc., One Monument Sq., suite 400, Portland, ME 04101.

Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str., 1113 Sofia, Bulgaria, has informed FDA that it has transferred ownership of, and all rights and interest in, approved NADA 141-472 for virginiamycin and diclazuril Type C medicated feed to Elanco US Inc., 2500 Innovation Way, Greenfield, IN 46140.

Accordingly, we are amending the regulations to reflect these changes.

IV. Change of Sponsors' Name and Addresses

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

V. Technical Amendments

FDA is making the following amendments to improve the readability and accuracy of the animal drug regulations:

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

VI. Legal Authority

This final rule is issued under section 512(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C.360b(i)), which requires Federal Register publication of “notice[s] . . . effective as a regulation,” of the conditions of use of approved new animal drugs. This rule sets forth technical amendments to the regulations to codify recent actions on approved new animal drug applications and corrections to improve the accuracy of the regulations, and as such does not impose any burden on regulated entities.

Although denominated a rule pursuant to the FD&C Act, this document does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a “rule of particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808. Likewise, this is not a rule subject to Executive Order 12866, which defines a rule as “an agency statement of general applicability and future effect, which the agency intends to have the force and effect of law, that is designed to implement, interpret, or prescribe law or policy or to describe the procedure or practice requirements of an agency.”

Start List of Subjects

List of Subjects

21 CFR Part 500

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

21 CFR Parts 520, 522, 524, and 526

  • Animal drugs

21 CFR Part 556

  • Animal drugs
  • Food

21 CFR Part 558

  • Animal drugs
  • Animal feeds
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 500, 510, 520, 522, 524, 526, 556, and 558 are amended as follows:

Start Part

PART 500—GENERAL

End Part Start Amendment Part

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

End Amendment Part Start Authority

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

End Authority Start Amendment Part

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

End Amendment Part
N-methyl-2-pyrrolidone.

(a) Standard for residues. No residues of n-methyl-2-pyrrolidone may be found in the uncooked edible tissues of cattle as determined by a method entitled “Method of Analysis: N-methyl-2-Start Printed Page 18118pyrrolidone,” September 26, 2011, Center for Veterinary Medicine, Food and Drug Administration, which is incorporated by reference with the approval of the Director of the Federal Register under 5 U.S.C. 522(a) and 1 CFR part 51. To obtain a copy of the analytical method, please submit a Freedom of Information request to: https://www.accessdata.fda.gov/​scripts/​foi/​FOIRequest/​requestinfo.cfm; or go to: https://www.fda.gov/​about-fda/​center-veterinary-medicine/​cvm-foia-electronic-reading-room. You may inspect a copy at the office of the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 301-827-6860, between 9 a.m. and 4 p.m., Monday through Friday or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, email fedreg.legal@nara.gov, or go to: www.archives.gov/​federal-register/​cfr/​ibr-locations.html.

* * * * *
Start Part

PART 510—NEW ANIMAL DRUGS

End Part Start Amendment Part

3. 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

4. In § 510.600:

End Amendment Part Start Amendment Part

a. In the table in paragraph (c)(1):

End Amendment Part Start Amendment Part

i. Remove the entry for “Cooperative Research Farms”;

End Amendment Part Start Amendment Part

ii. Add entries for “Dechra Veterinary Products LLC” and “Mizner Bioscience LLC” in alphabetical order;

End Amendment Part Start Amendment Part

iii. Remove the entries for “Putney, Inc.” and “Strategic Veterinary Pharmaceuticals, Inc.”;

End Amendment Part Start Amendment Part

iv. Revise the entry for “Virbac AH, Inc.”; and

End Amendment Part Start Amendment Part

v. Add an entry for “Wildcat Feeds” in alphabetical order; and

End Amendment Part Start Amendment Part

b. In the table in paragraph (c)(2):

End Amendment Part Start Amendment Part

i. Revise the entry for “026637”;

End Amendment Part Start Amendment Part

ii. Remove the entry for “051267”;

End Amendment Part Start Amendment Part

iii. Revise the entry for “051311”;

End Amendment Part Start Amendment Part

iv. Remove the entry for “054628”; and

End Amendment Part Start Amendment Part

v. Add entries for “086039” and “086113” in numerical order.

End Amendment Part

The revisions and additions read as follows:

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

(c) * * *

(1) * * *

Firm name and addressDrug labeler code
*         *         *         *         *         *         *
Dechra Veterinary Products LLC, 7015 College Blvd., Suite 525, Overland Park, KS 66211026637
*         *         *         *         *         *         *
Mizner Bioscience LLC, 225 NE Mizner Blvd., Suite 760, Boca Raton, FL 33432086039
*         *         *         *         *         *         *
Virbac AH, Inc., PO Box 162059, Fort Worth, TX 76161051311
*         *         *         *         *         *         *
Wildcat Feeds, 215 NE Strait Ave., Topeka, KS 66616086113
*         *         *         *         *         *         *

(2) * * *

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

PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS

End Part Start Amendment Part

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

End Amendment Part Start Authority

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

End Authority
[Amended]
Start Amendment Part

6. In § 520.88c(c), remove “§ 556.510” and in its place add “§ 556.38”.

End Amendment Part
[Redesignated as §§ 520.90a and 520.90b]
Start Amendment Part

7. Redesignate §§ 520.90b and 520.90c as §§ 520.90a and 520.90b.

End Amendment Part Start Amendment Part

8. Remove §§ 520.90d and 520.90e.

End Amendment Part
[Redesignated as § 520.90c and Amended]
Start Amendment Part

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

End Amendment Part
Start Printed Page 18119
Ampicillin boluses.
* * * * *

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

* * * * *

(d) Conditions of use in nonruminating calves—(1) Amount. 5 milligrams per pound of body weight twice daily not to exceed 4 days.

(2) Indications for use. Oral treatment of bacterial enteritis (colibacillosis) caused by E. coli.

(3) Limitations. Treated calves must not be slaughtered for food during treatment and for 7 days after the last treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[Amended]
Start Amendment Part

10. In § 520.260(b)(2), remove “No. 038782 for 884 or 1,768 milligram or 4.42 gram capsules;”.

End Amendment Part
[Amended]
Start Amendment Part

11. In § 520.455(b), remove “No. 058198” and in its place add “Nos. 058198 and 086039”.

End Amendment Part
[Redesignated as §§ 520.903c and 520.903d]
Start Amendment Part

12. Redesignate §§ 520.903d and 520.903e as §§ 520.903c and 520.903d.

End Amendment Part
[Redesignated as § 520.1263b]
Start Amendment Part

13. Redesignate § 520.1263c as § 520.1263b.

End Amendment Part Start Amendment Part

14. Revise § 520.1286 to read as follows:

End Amendment Part
Lotilaner.

(a) Specifications. Each chewable tablet contains:

(1) For use in dogs: 56.25, 112.5, 225, 450, or 900 milligrams (mg) lotilaner; or

(2) For use in cats: 12 or 48 mg lotilaner.

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

(c) Conditions of use—(1) Dogs—(i) Amount. Administer orally once a month at the recommended minimum dosage of 9 mg/lb (20 mg/kg).

(ii) Indications for use. Kills adult fleas, and for the treatment and prevention of flea infestations (Ctenocephalides felis), and the treatment and control of tick infestations (Amblyomma americanum (lone star tick), Dermacentor variabilis (American dog tick), Ixodes scapularis (black-legged tick), and Rhipicephalus sanguineus (brown dog tick)) for 1 month in dogs and puppies 8 weeks of age or older and weighing 4.4 pounds or greater.

(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) Cats—(i) Amount. Administer orally once a month at the recommended minimum dosage of 2.7 mg/lb (6 mg/kg).

(ii) Indications for use. Kills adult fleas, and for the treatment and prevention of flea infestations (Ctenocephalides felis) for 1 month in cats and kittens 8 weeks of age or older and weighing 2 pounds or greater.

(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Start Amendment Part

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

End Amendment Part
Oxytetracycline powder.
* * * * *

(d) * * *

(2) * * *

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

* * * * *
[Redesignated as §§ 520.1696a, 520.1696b, and 520.1696c]
Start Amendment Part

16. Redesignate §§ 520.1696b, 520.1696c, and 520.1696d as §§ 520.1696a, 520.1696b, and 520.1696c.

End Amendment Part
[Amended]
Start Amendment Part

17. In § 520.2218(c), remove “§§ 556.670 and 556.685” and in its place add “§§ 556.660, 556.670, and 556.685”.

End Amendment Part
[Amended]
Start Amendment Part

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

End Amendment Part Start Amendment Part

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

End Amendment Part
Tiamulin.
* * * * *

(b) * * *

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

* * * * *
Start Part

PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

End Part Start Amendment Part

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

End Amendment Part Start Authority

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

End Authority Start Amendment Part

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

End Amendment Part
Dihydrostreptomycin sulfate injection.
* * * * *

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

* * * * *
Start Amendment Part

22. Add § 522.728 to read as follows:

End Amendment Part
Dipyrone.

(a) Specifications. Each milliliter of solution contains 500 milligrams (mg) dipyrone.

(b) Sponsor. See No. 086078 in § 510.600(c) of this chapter.

(c) Conditions of use in horses—(1) Amount. Administer 30 mg per kilogram of body weight (13.6 mg per pound) by intravenous injection, once or twice daily at a 12-hour interval for up to 3 days.

(2) Indications for use. For control of pyrexia in horses.

(3) Limitations. Do not use in horses intended for human consumption. Do not use in any food-producing animals, including lactating dairy animals. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[Removed]
Start Amendment Part

23. Remove § 522.900.

End Amendment Part
[Amended]
Start Amendment Part

24. In § 522.1367(c)(1)(i), remove “§ 520.1350(c)” and in its place add “§ 520.1367(c)”.

End Amendment Part
[Amended]
Start Amendment Part

25. In § 522.1662a:

End Amendment Part Start Amendment Part

a. Redesignate paragraphs (a) through (e) as paragraphs (b) through (f);

End Amendment Part Start Amendment Part

b. Further redesignate newly redesignated paragraphs (c)(3)(i)( a) through (c) and (c)(3)(ii)(a) through (c) as paragraphs (c)(3)(i)(A) through (C) and (c)(3)(ii)(A) through (C), respectively;

End Amendment Part Start Amendment Part

c. Further redesignate newly redesignated paragraphs (e)(3)(i)( a) through (c) as paragraphs (e)(3)(i)(A) through (C);

End Amendment Part Start Amendment Part

d. Further redesignate newly redesignated paragraphs (e)(3)(ii)( a) and (b) and paragraphs (e)(3)(ii)(A) and (B);

End Amendment Part Start Amendment Part

e. Further redesignate newly redesignated paragraphs (e)(3)(iii)( a) through (c) as paragraphs (e)(3)(iii)(A) through (C);

End Amendment Part Start Amendment Part

f. In newly redesignated paragraph (e)(3)(iii)(C), remove “paragraph (d)(3)(iii)( c) of this section” and in its place add “this paragraph (e)(3)(iii)(C)”;

End Amendment Part Start Amendment Part

g. Further redesignate newly redesignated paragraphs (f)(3)(i)( a) through (c) and (f)(3)(ii)(a) through (c) as paragraphs (f)(3)(i)(A) through (C) and (f)(3)(ii)(A) through (C), respectively;

End Amendment Part Start Amendment Part

h. Redesignate paragraphs (g)(3)(i)( a) through (c) and (g)(3)(ii)(a) through (c) as paragraphs (g)(3)(i)(A) through (C) Start Printed Page 18120and (g)(3)(ii)(A) through (C), respectively; and

End Amendment Part Start Amendment Part

i. Redesignate paragraph (k) as paragraph (j) and paragraph (l) as paragraph (a).

End Amendment Part
[Amended]
Start Amendment Part

26. In § 522.1696a(b)(1) and (2) and (d)(2)(iii), remove “, 055529,”.

End Amendment Part
[Amended]
Start Amendment Part

27. In § 522.1696b:

End Amendment Part Start Amendment Part

a. In paragraph (b)(1), remove “016592, 054771, and 055529” and in its place add “016592 and 054771”;

End Amendment Part Start Amendment Part

b. Remove paragraphs (d)(2)(i)(A) and (B); and

End Amendment Part Start Amendment Part

c. In paragraph (d)(2)(iii)(B), remove “Nos. 000859 and 055529” and in its place add “No. 016592”.

End Amendment Part Start Amendment Part

28. Add § 522.1697 to read as follows:

End Amendment Part
Pentobarbital and phenytoin.

(a) Specifications. Each milliliter (mL) of solution contains 390 milligrams (mg) pentobarbital sodium and 50 mg phenytoin sodium.

(b) Sponsors. See Nos. 000061, 051311, and 054925 in § 510.600(c) of this chapter.

(c) Special considerations. Product labeling shall bear the following warning statements: “ENVIRONMENTAL HAZARD: This product is toxic to wildlife. Birds and mammals feeding on treated animals may be killed. Euthanized animals must be properly disposed of by deep burial, incineration, or other method in compliance with State and local laws, to prevent consumption of carcass material by scavenging wildlife.”

(d) Conditions of use in dogs—(1) Amount. Administer 1 mL per 10 pounds of body weight as a single, bolus intravenous or intracardiac injection.

(2) Indications for use. For humane, painless, and rapid euthanasia.

(3) Limitations. Do not use in animals intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Start Amendment Part

29. Add § 522.2092 to read as follows:

End Amendment Part
Secobarbital and dibucaine.

(a) Specifications. Each milliliter (mL) of solution contains 400 milligram (mg) secobarbital sodium and 25 mg dibucaine hydrochloride.

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

(c) Special considerations. Product labeling shall bear the following warning statements: “ENVIRONMENTAL HAZARD: This product is toxic to wildlife. Birds and mammals feeding on treated animals may be killed. Euthanized animals must be properly disposed of by deep burial, incineration, or other method in compliance with State and local laws, to prevent consumption of carcass material by scavenging wildlife.”

(d) Conditions of use in dogs—(1) Amount. Administer 1 mL per 10 pounds of body weight as a single, bolus intravenous injection.

(2) Indications for use. For humane, painless, and rapid euthanasia.

(3) Limitations. Do not use in animals intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Start Part

PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

End Part Start Amendment Part

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

End Amendment Part Start Authority

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

End Authority Start Amendment Part

31. Add an undesignated center heading before § 524.981 to read as follows:

End Amendment Part

Fluocinolone Topical and Otic Dosage Forms

Start Amendment Part

32. Add § 524.1001 to read as follows:

End Amendment Part
Furalaner and moxidectin.

(a) Specifications. Each milliliter of solution contains 280 milligram (mg) furalaner and 14 mg moxidectin. Each individually packaged tube contains either 112.5 mg furalaner and 5.6 mg moxidectin; 250 mg furalaner and 12.5 mg moxidectin; or 500 mg furalaner and 25 mg moxidectin.

(b) Sponsor. See No. 000061 in § 510.600(c) of this chapter.

(c) Conditions of use—(1) Amount. Administer topically as a single dose every 2 months to provide a minimum dose of 18.2 mg/lb (40 mg/kg) fluralaner and 0.9 mg/lb (2 mg/kg) moxidectin.

(2) Indications for use. For the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment of infections with intestinal roundworm (Toxocara cati, 4th stage larvae, immature adults, and adults) and hookworm (Ancylostoma tubaeforme, 4th stage larvae, immature adults, and adults); kills adult fleas and is indicated for the treatment and prevention of flea infestations (Ctenocephalides felis) and the treatment and control of tick infestations (Ixodes scapularis (black-legged tick) and Dermacentor variabilis (American dog tick)) for 2 months in cats and kittens 6 months of age and older and weighing 2.6 lb or greater.

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

Start Amendment Part

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

End Amendment Part
Imidacloprid and moxidectin.

(a) Specifications. Each milliliter of solution contains:

(1) 100 milligrams (mg) imidacloprid and 25 mg moxidectin; or

(2) 100 mg imidacloprid and 10 mg moxidectin.

(b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter as follows:

(1) Nos. 000859 and 017030 for use of product described in paragraph (a)(1) of this section as in paragraph (d)(1) of this section.

(2) No. 000859 for use of product described in paragraph (a)(2) of this section as in paragraphs (d)(2) and (3) of this section.

* * * * *
Start Amendment Part

34. In § 524.1742:

End Amendment Part Start Amendment Part

a. Revise the section heading;

End Amendment Part Start Amendment Part

b. Redesignate paragraphs (c) and (d) as paragraphs (d) and (c), respectively;

End Amendment Part Start Amendment Part

c. Add a heading for the table in newly redesignated paragraph (d)(1) introductory text; and

End Amendment Part Start Amendment Part

d. Further redesignate newly redesignated paragraphs (d)(1)(i)( a) and (b) as paragraphs (d)(1)(i)(A) and (B).

End Amendment Part

The revision and addition reads as follows:

Phosmet emulsifiable liquid.
* * * * *

(d) * * *

(1) * * *

Table 1 to Paragraph (d)(1)

* * * * *
[Amended]
Start Amendment Part

35. In § 524.2098(b), remove “054771” and in its place add “Nos. 054771 and 055529”.

End Amendment Part Start Part

PART 526—INTRAMAMMARY DOSAGE FORM NEW ANIMAL DRUGS

End Part Start Amendment Part

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

End Amendment Part Start Authority

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

End Authority
[Removed]
Start Amendment Part

37. Remove § 526.464b.

End Amendment Part
[Redesignated as § 526.464b]
Start Amendment Part

38. Redesignate § 526.464c as § 526.464b.

End Amendment Part Start Part

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

End Part Start Amendment Part

39. 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
[Amended]
Start Amendment Part

40. In § 556.40(c), remove “§§ 520.90e, 520.90f, 522.90a, and 522.90b” and in Start Printed Page 18121its place add “§§ 520.90c, 522.90a, and 522.90b”.

End Amendment Part
[Amended]
Start Amendment Part

41. In § 556.165(c), remove “§§ 526.464a, 526.464b, and 526.464c” and in its place add “§§ 526.464a and 526.464b”.

End Amendment Part
[Removed]
Start Amendment Part

42. Remove § 556.168.

End Amendment Part
[Amended]
Start Amendment Part

43. In § 556.230, remove paragraph (b)(3).

End Amendment Part
[Amended]
Start Amendment Part

44. In § 556.304(c), remove “§§ 522.1077, 522.1079, and 522.1081” and in its place add “§§ 522.1079 and 522.1081”.

End Amendment Part
[Amended]
Start Amendment Part

45. In § 556.344:

End Amendment Part Start Amendment Part

a. In paragraph (a), remove “1 μg/kg” and in its place add “5 μg/kg”;

End Amendment Part Start Amendment Part

b. In paragraph (b)(2)(i), remove “100 ppb” and in its place add “1.6 ppm”; and

End Amendment Part Start Amendment Part

c. In paragraph (b)(2)(ii), remove “10 ppb” and in its place add “650 ppb”.

End Amendment Part Start Amendment Part

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

End Amendment Part
Lincomycin.
* * * * *

(b) * * *

(3) Honey. 750 ppb.

(c) Related conditions of use. See §§ 520.1263b, 522.1260, and 558.325 of this chapter.

Start Amendment Part

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

End Amendment Part
Oxytetracycline.
* * * * *

(b) * * *

(6) Honey. 750 ppb.

* * * * *
[Amended]
Start Amendment Part

48. In § 556.510(c), remove “520.1696b” and in its place add “520.1696a”.

End Amendment Part
[Amended]
Start Amendment Part

49. In § 556.660(c), remove “§ 558.582” and in its place add “§§ 520.2218 and 558.582”.

End Amendment Part
[Amended]
Start Amendment Part

50. In § 556.670, in paragraph (c), remove “§§ 520.2260a, 520.2260b, 520.2260c, 520.2261a, 520.2261b, 522.2260, 558.140, and 558.630” and in its place add “§§ 520.2218, 520.2260a, 520.2260b, 520.2260c, 520.2261a, 520.2261b, 522.2260, 558.140, and 558.630”.

End Amendment Part
[Amended]
Start Amendment Part

51. In § 556.685(c), remove “§§ 520.2325a, 520.2325b, and 558.586” and in its place add “§§ 520.2218, 520.2325a, 520.2325b, and 558.586”.

End Amendment Part
[Amended]
Start Amendment Part

52. In § 556.733(a), remove “10 μg/kg” and in its place add “50 μg/kg”.

End Amendment Part Start Amendment Part

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

End Amendment Part
Tylosin.
* * * * *

(b) * * *

(4) Honey. 500 ppb.

* * * * *
[Amended]
Start Amendment Part

54. In § 556.750, remove paragraph (b)(4).

End Amendment Part Start Amendment Part

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

End Amendment Part
Zilpaterol.
* * * * *

(b) * * *

(1) Cattle. (i) Liver (target tissue): 12 ppb.

(ii) Muscle: 10 ppb.

* * * * *
Start Part

PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

End Part Start Amendment Part

56. 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

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

End Amendment Part
Amprolium.
* * * * *

(d) * * *

(5) Permitted combinations. Amprolium may also be used in combination with:

(i) Virginiamycin as in § 558.635.

(ii) [Reserved]

Start Amendment Part

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

End Amendment Part
Bacitracin methylenedisalicylate.
* * * * *

(e) * * *

(2) * * *

(vii) Fenbendazole as in § 558.258.

(viii) Halofuginone as in § 558.265.

* * * * *

(xi) Monensin as in § 558.355.

* * * * *
[Removed]
Start Amendment Part

59. Remove § 558.185.

End Amendment Part Start Amendment Part

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

End Amendment Part
Decoquinate.
* * * * *

(e) * * *

(2) * * *

Start Printed Page 18122
Decoquinate in grams/tonCombination in grams/tonIndications for useLimitationsSponsor
*         *         *         *         *         *         *
(ii) 12.9 to 90.8Monensin, 5 to 30Cattle fed in confinement for slaughter: For prevention of coccidiosis caused by Eimeria bovis and E. zuernii; and for improved feed efficiencyFeed continuously as the sole ration to provide 22.7 mg of decoquinate per 100 lb of body weight per day and 50 to 360 mg of monensin per head per day. Feed at least 28 days during period of exposure to coccidiosis or when it is likely to be a hazard. Do not feed to animals producing milk for food. Do not feed to lactating dairy cattle. Also see paragraph (d)(1) of this section and § 558.355(d)(9)(i). Monensin as provided by No. 016592 or 058198 in § 510.600(c) of this chapter016592, 054771.
*         *         *         *         *         *         *
* * * * *
Start Amendment Part

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

End Amendment Part
Melengestrol.
* * * * *

(e) * * *

(1) * * *

Melengestrol acetate in mg/head/dayCombination in grams/tonIndications for useLimitationsSponsor
*         *         *         *         *         *         *
(iv) 0.25 to 0.5Monensin, 10 to 40Heifers fed in confinement for slaughter: For increased rate of weight gain, improved feed efficiency, and suppression of estrus (heat); and for the prevention and control of coccidiosis due to Eimeria bovis and E. zuernii.Add at the rate of 0.5 to 2 lb/head/day a medicated feed (liquid or dry) containing 0.125 to 1 mg melengestrol acetate/lb to a feed containing 10 to 40 g of monensin per ton to provide 0.25 to 0.5 mg melengestrol acetate/head/day and 0.14 to 0.42 mg monensin/lb body weight, depending on severity of coccidiosis challenge, up to 480 mg monensin/head/day. See § 558.355(d). Monensin as provided by No. 016592 or 058198 in § 510.600(c) of this chapter016592, 054771, 058198
*         *         *         *         *         *         *
* * * * *
Start Amendment Part

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

End Amendment Part
Monensin.
* * * * *

(f) * * *

(4) * * *

Monensin amountIndications for useLimitationsSponsor
*         *         *         *         *         *         *
(iv) 400 mg 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 mg 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 mg per head per day and higher has been fatal. The effectiveness of this block in cull cows and bulls has not been established. See paragraph (d)(10)(i) of this section086113
*         *         *         *         *         *         *
* * * * *
Start Amendment Part

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

End Amendment Part
Ractopamine.
* * * * *

(e) * * *

(2) Cattle. Start Printed Page 18123

Ractopamine in grams/tonCombination in grams/tonIndications for useLimitationsSponsor
(i) 8.2 to 24.6Cattle fed in confinement for slaughter: For increased rate of weight gain and improved feed efficiency during the last 28 to 42 days on feedFeed continuously as sole ration during the last 28 to 42 days on feed054771 058198
(ii) 8.2 to 24.6Monensin 10 to 40 to provide 0.14 to 0.42 mg monensin/lb of body weight, depending on severity of coccidiosis challenge, up to 480 mg/head/day.Cattle fed in confinement for slaughter: For increased rate of weight gain and improved feed efficiency during the last 28 to 42 days on feed, and for prevention and control of coccidiosis due to Eimeria bovis and E. zuerniiFeed continuously as sole ration during the last 28 to 42 days on feed. See paragraph § 558.355(d). Ractopamine as provided by No. 058198 or 054771; monensin as provided by No. 016592 or 058198 in § 510.600(c) of this chapter016592 054771 058198
(iii) 9.8 to 24.6Cattle fed in confinement for slaughter: For increased rate of weight gain, improved feed efficiency, and increased carcass leanness during the last 28 to 42 days on feedFeed continuously as sole ration during the last 28 to 42 days on feed. Not for animals intended for breeding054771 058198
(iv) 9.8 to 24.6Monensin 10 to 40 to provide 0.14 to 0.42 mg monensin/lb of body weight, depending on severity of coccidiosis challenge, up to 480 mg/head/dayCattle fed in confinement for slaughter: For increased rate of weight gain, improved feed efficiency, and increased carcass leanness during the last 28 to 42 days on feed, and for prevention and control of coccidiosis due to Eimeria bovis and E. zuerniiFeed continuously as sole ration during the last 28 to 42 days on feed. Not for animals intended for breeding. See paragraph § 558.355(d). Ractopamine as provided by No. 058198 or 054771; monensin as provided by No. 016592 or 058198 in § 510.600(c) of this chapter016592 054771 058198
(v) 9.8 to 24.6Monensin 10 to 40 to provide 0.14 to 0.42 mg monensin/lb of body weight, depending on severity of coccidiosis challenge, up to 480 mg/head/day, plus melengestrol acetate to provide 0.25 to 0.5 mg/head/dayHeifers fed in confinement for slaughter: For increased rate of weight gain, improved feed efficiency, and increased carcass leanness during the last 28 to 42 days on feed, and for prevention and control of coccidiosis due to Eimeria bovis and E. zuernii, and for suppression of estrus (heat)Feed continuously as sole ration during the last 28 to 42 days on feed. Not for animals intended for breeding. See §§ 558.342(d) and 558.355(d). Melengestrol acetate as provided by No. 058198 or 054771; monensin as provided by No. 016592 or 058198 in § 510.600(c) of this chapter016592 054771 058198
(vi) Not to exceed 800; to provide 70 to 400 mg/head/dayCattle fed in confinement for slaughter: For increased rate of weight gain and improved feed efficiency during the last 28 to 42 days on feedTop dress in a minimum of 1 lb of medicated feed054771 058198
(vii) Not to exceed 800; to provide 70 to 400 mg/head/dayMonensin 10 to 40 to provide 0.14 to 0.42 mg monensin/lb of body weight, depending on severity of coccidiosis challenge, up to 480 mg/head/dayCattle fed in confinement for slaughter: For increased rate of weight gain and improved feed efficiency during the last 28 to 42 days on feed, and for prevention and control of coccidiosis due to Eimeria bovis and E. zuerniiTop dress ractopamine in a minimum of 1 lb of medicated feed during the last 28 to 42 days on feed. Not for animals intended for breeding. See § 558.355(d). Ractopamine as provided by No. 058198 or 054771; monensin as provided by No. 016592 or 058198 in § 510.600(c) of this chapter016592 054771 058198
* * * * *
Start Amendment Part

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

End Amendment Part
Tilmicosin.
* * * * *

(e) * * *

(2) * * *

Start Printed Page 18124
Tilmicosin phosphate in grams/tonCombination in grams/tonIndications for useLimitationsSponsor
*         *         *         *         *         *         *
(ii) 568 to 757Monensin, 5 to 40Cattle fed in confinement for slaughter: For improved feed efficiency; and for the control of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni in groups of cattle fed in confinement for slaughter, where active BRD has been diagnosed in at least 10 percent of the animals in the groupFeed continuously for 14 days to provide 12.5 mg tilmicosin/kg of bodyweight/day. The safety of tilmicosin has not been established in cattle intended for breeding purposes. This drug product is not approved for use in female dairy cattle 20 months of age or older. Use in these cattle may cause drug residues in milk. This drug product is not approved for use in calves intended to be processed for veal. A withdrawal period has not been established in pre-ruminating calves. Cattle intended for human consumption must not be slaughtered within 28 days of the last treatment with this drug product. See § 558.355(d). Tilmicosin as provided by No. 016592 or 058198; monensin as provided by No. 016592 or 058198 in § 510.600(c) of this chapter016592 058198
(iii) 568 to 757Monensin, 10 to 40Cattle fed in confinement for slaughter: For prevention and control of coccidiosis due to Eimeria bovis and E. zuernii; and for the control of BRD associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni in groups of cattle fed in confinement for slaughter, where active BRD has been diagnosed in at least 10 percent of the animals in the groupFeed continuously for 14 days to provide 12.5 mg tilmicosin/kg of bodyweight/day. The safety of tilmicosin has not been established in cattle intended for breeding purposes. This drug product is not approved for use in female dairy cattle 20 months of age or older. Use in these cattle may cause drug residues in milk. This drug product is not approved for use in calves intended to be processed for veal. A withdrawal period has not been established in pre-ruminating calves. Cattle intended for human consumption must not be slaughtered within 28 days of the last treatment with this drug product. See § 558.355(d). Tilmicosin as provided by No. 016592 or 058198; monensin as provided by No. 016592 or 058198 in § 510.600(c) of this chapter016592 058198
Start Amendment Part

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

End Amendment Part
Tylosin.
* * * * *

(e) * * *

(2) * * *

Tylosin grams/tonCombination in grams/tonIndications for useLimitationsSponsor
*         *         *         *         *         *         *
(vi) 8 to 10Monensin, 5 to 30 plus decoquinate, 13.6 to 22.7Cattle fed in confinement for slaughter: For reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium pyogenes; for the prevention of coccidiosis caused by Eimeria bovis and E. zuernii; and for improved feed efficiencyFeed continuously as the sole ration to provide 22.7 mg of decoquinate per 100 lb body weight per day, 50 to 360 mg of monensin/head/day, and 60 to 90 mg of tylosin/head/day. Feed at least 28 days during period of exposure to coccidiosis or when it is likely to be a hazard. Do not feed to animals producing milk for food. Do not feed to lactating dairy cattle. A withdrawal time has not been established for pre-ruminating calves. Do not use in calves to be processed for veal. Tylosin as provided by No. 016592 or 058198; monensin as provided by No. 016592 or 058198; decoquinate as provided by No. 058198 in § 510.600(c) of this chapter. See §§ 558.311(d) and 558.355(d)016592 054771
Start Printed Page 18125
*         *         *         *         *         *         *
(ix) 8 to 10Monensin, 10 to 40 plus melengestrol, 0.25 to 2.0Heifers fed in confinement for slaughter: For reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes; for prevention and control of coccidiosis caused by Eimeria bovis and E. zuernii; and for increased rate of weight gain, improved feed efficiency, and suppression of estrus (heat)Feed continuously as sole ration to heifers at a rate of 0.5 to 2 pounds per head per day to provide 0.25 to 0.5 mg/head/day melengestrol acetate and 0.14 to 0.42 mg monensin/lb body weight per day, depending on the severity of the coccidiosis challenge, up to 480 mg/head/day and 60 to 90 mg/head/day tylosin. The melengestrol acetate portion of this Type C medicated feed must be mixed into the complete feed containing 10 to 40 g/ton monensin and 8 to 10 g/ton tylosin at feeding into the amount of complete feed consumed by an animal per day. A withdrawal time has not been established for pre-ruminating calves. Do not use in calves to be processed for veal. Tylosin provided by No. 016592 or 058198; monensin as provided by No. 016592 or 058198; melengestrol provided by No. 054771 or 058198 in § 510.600(c) of this chapter. See §§ 558.342(d) and 558.355(d)016592 054771 058198
*         *         *         *         *         *         *
Start Amendment Part

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

End Amendment Part
Virginiamycin.
* * * * *

(e) * * *

(1) * * *

Virginiamycin grams/tonCombination in grams/tonIndications for useLimitationsSponsor
*         *         *         *         *         *         *
(iv) 20Diclazuril, 0.91Broiler chickens: For prevention of necrotic enteritis caused by Clostridium perfringens susceptible to virginiamycin; and for the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mitis (mivati), and E. maxima. Because diclazuril is effective against E. maxima late in its life cycle, subclinical intestinal lesions may be present for a short time after infection. Diclazuril was shown in studies to reduce lesions scores and improve performance and health of birds challenged with E. maximaFeed continuously as the sole ration. Do not use in hens producing eggs for human food. Diclazuril as provided by No. 058198 in § 510.600(c) of this chapter058198
*         *         *         *         *         *         *
* * * * *
Start Signature

Dated: March 25, 2020.

Lowell J. Schiller,

Principal Associate Commissioner for Policy.

End Signature End Supplemental Information

[FR Doc. 2020-06688 Filed 3-30-20; 8:45 am]

BILLING CODE 4164-01-P