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New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsorship; Change of Sponsors' Names and Addresses

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Start Preamble Start Printed Page 39179

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 January, February, and March 2019. FDA is informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. Technical amendments are also being made to improve the accuracy, consistency, and readability of the regulations.

DATES:

This rule is effective August 9, 2019, except for amendatory instructions 51 to 21 CFR 524.916 and 63 to 21 CFR 558.325, which are effective August 19, 2019, and instruction 60 to 21 CFR 558.235, which is effective September 9, 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 January, February, and March 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/​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 January, February, and March 2019

Approval dateFile No.SponsorProduct nameSpeciesEffect of the actionPublic documents
January 27, 2019009-476Phibro Animal Health Corp., GlenPointe Centre East, 3d Floor, 300 Frank W. Burr Blvd., Suite 21, Teaneck, NJ 07666NICARB 25% (nicarbazin) Type A medicated articleChickensSupplemental approval of revised assay limits for nicarbazin (powder) Type A medicated articleN/A.
January 28, 2019200-616Norbrook Laboratories, Ltd., Station Works, Newry BT35 6JP, Northern IrelandCEFENIL RTU (ceftiofur hydrochloride sterile suspension)Swine and cattleOriginal approval as a generic copy of NADA 140-890FOI Summary.
January 31, 2019200-450Bimeda Animal Health Ltd., 1B The Herbert Building, The Park, Carrickmines, Dublin, 18, IrelandBIMECTIN PLUS (ivermectin/clorsulon) Injection for CattleCattleOriginal approval as a generic copy of NADA 140-833FOI Summary.
February 4, 2019200-637Provetica AH LLC, 455 Sovereign Ct., Baldwin, MO 63011DOXIDYL (deracoxib) Chewable TabletDogsOriginal approval as a generic copy of NADA 141-203FOI Summary.
February 8, 2019141-297Boehringer Ingelheim Vetmedica, Inc., 2621 North Belt Highway, St. Joseph, MO 64506-2002PROZINC (protamine zinc recombinant human insulin) Injectable SuspensionDogsSupplemental approval for the reduction of hyperglycemia and hyperglycemia-associated clinical signs in dogs with diabetes mellitusFOI Summary.
Start Printed Page 39180
March 29, 2019048-761Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007AUREOMYCIN (chlortetracycline) Type C medicated feedsCattleSupplemental approval adding replacement dairy heifers to the indications for use of chlortetracycline Type C medicated cattle feeds for control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetracyclineN/A.
March 29, 2019141-517Pegasus Laboratories, Inc., 8809 Ely Rd., Pensacola, FL 32514PROIN ER (phenylpropanolamine hydrochloride extended-release tablets) TabletsDogsOriginal approval for the control of urinary incontinence due to urethral sphincter hypotonusFOI Summary.

II. Changes of Sponsors' Names and Addresses

Aurora Pharmaceutical, LLC, 1196 Highway 3 South, Northfield, MN 55057-3009 has informed FDA that it has changed its name to Aurora Pharmaceutical, Inc.

Boehringer Ingelheim Vetmedica, Inc., 2621 North Belt Highway, St. Joseph, MO 64506-2002 has informed FDA that it has changed its name and address to Boehringer Ingelheim Animal Health USA, Inc., 3239 Satellite Blvd., Duluth, GA 30096.

Luitpold Pharmaceuticals, Inc., Animal Health Division, Shirley, NY 11967 has informed FDA that it has changed its name to American Regent, Inc.

Pharmgate LLC, 1800 Sir Tyler Dr., Wilmington, NC 28405 has informed FDA that it has changed its name to Pharmgate, Inc.

Accordingly, we are amending § 510.600(c) to reflect these changes.

III. Changes of Sponsorship

Provetica AH LLC, 455 Sovereign Ct., Baldwin, MO 63011 has informed FDA that it has transferred ownership of, and all rights and interest in, newly approved ANADA 200-637 for DOXIDYL (deracoxib) Chewable Tablets to Ceva Sante Animale, 10 Avenue de la Ballastière, 33500 Libourne, France. Following this change of sponsorship, Provetica AH LLC is no longer the sponsor of an approved application. Accordingly, it will not be added to the list of sponsors of approved applications in § 510.600(c) (21 CFR 510.600(c)).

Merial, Inc., 3239 Satellite Blvd., Bldg. 500, Duluth, GA 30096-4640 has informed FDA that it has transferred ownership of, and all rights and interest in, the following applications to Boehringer Ingelheim Animal Health USA, Inc., 3239 Satellite Blvd., Duluth, GA 30096:

File No.Proprietary name
006-623CAPARSOLATE (arsenamide sodium) Injection.
008-422SELEEN (selenium disulfide) Suspension.
010-424NALLINE (nalorphine hydrochloride) Injection.
011-080HYDELTRONE-TBA (prednisolone and tertiary butylacetate) Suspension.
011-437HYDELTRONE (prednisolone sodium phosphate and neomycin sulfate) Ointment.
011-532SULFABROM (sulfabromomethazine sodium) Bolus.
011-678DIURIL (chlorothiazide) Tablets.
012-734DIURIL (chlorothiazide) Bolus.
013-022THIBENZOLE (thiabendazole) Sheep & Goat Wormer.
013-407EQUIZOLE (thiabendazole) Horse Wormer.
013-674HYDROZIDE (hydrochlorothiazide) Injection.
013-954THIBENZOLE (thiabendazole) 20% Swine Premix.
014-350OMNIZOLE (thiabendazole).
015-123TBZ® (thiabendazole) Cattle Wormer (Drench).
015-875TBZ 200 (thiabendazole) Medicated Premix.
030-103THIBENZOLE (thiabendazole) Suspension.
034-114EQUIZOLE (thiabendazole).
035-631THIBENZOLE (thiabendazole) Pig Wormer.
037-410EQUIZOLE A (thiabendazole and piperazine phosphate).
042-633TRESADERM (thiabendazole, dexamethasone, neomycin sulfate solution) Dermatologic Solution.
043-141THIBENZOLE 300 (thiabendazole) Medicated.
044-654EQUIZOLE (thiabendazole) Horse Wormer Pellets.
047-333EQUIZOLE A (thiabendazole and piperazine citrate) Liquid.
048-487TBZ (thiabendazole) Wormer Paste 50%.
042-633TRESADERM (thiabendazole, dexamethasone, neomycin sulfate solution) Dermatologic Solution.
043-141THIBENZOLE 300 (thiabendazole) Medicated.
044-654EQUIZOLE (thiabendazole) Horse Wormer Pellets.
047-333EQUIZOLE A (thiabendazole and piperazine citrate) Liquid.
048-487TBZ (thiabendazole) Wormer Paste 50%.
049-461TBZ (thiabendazole) Wormer Paste 43%.
065-275Penicillin VK Filmtab (penicillin V potassium) 250 mg.
065-276VEESYN (penicillin V potassium) Granules for Oral Solution.
094-642CAMVET (cambendazole) Suspension Horse Wormer.
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096-506CAMVET (cambendazole) Horse Wormer Pellets.
096-731CAMVET (cambendazole) Horse Wormer Paste 45%.
098-379CYSTORELIN.
098-689EQUIZOLE (thiabendazole) 50% Wormer Paste; EQUIZOLE 50% Wormer Paste for Horses.
127-443EQVALAN (ivermectin) Injection.
128-409IVOMEC (ivermectin) .27% Injection Grower and Feeder Pigs; IVOMEC (ivermectin) 1% Injection; IVOMEC (ivermectin) 1% Injection for Cattle and Swine; IVOMEC (ivermectin) Injection for Cattle.
131-392IVOMEC (ivermectin) Liquid for Sheep.
134-314EQVALAN (ivermectin).
134-930SYNCRO-MATE-B (norgestomet and estradiol valerate) Implant.
136-742CURATREM (clorsulon) Drench for Cattle.
137-006IVOMEC (ivermectin) Cattle Paste 0.153%.
138-412HEARTGARD (ivermectin) Tablets.
140-439EQVALAN (ivermectin) Oral Liquid for Horses.
140-818PRODUCIL (efrotomycin) Type A Medicated Article for Swine.
140-833IVOMEC Plus (ivermectin and clorsulon) Injection For Cattle.
140-841IVOMEC (ivermectin) Pour-On.
140-883LEGEND (hyaluronate sodium) Injectable Solution.
140-886HEARTGARD (ivermectin) Chewables for Dogs.
140-971HEARTGARD Plus (ivermectin and pyrantel pamoate).
140-974IVOMEC (ivermectin) Premix for Swine.
140-988IVOMEC (ivermectin) Sustained-Release Bolus for Cattle.
141-015ENACARD (enalapril maleate) Tablets for Dogs.
141-042IMMITICIDE (melarsomine dihydrochloride) Sterile Powder.
141-054IVOMEC (ivermectin) plus LINCOMIX (lincomycin).
141-078HEARTGARD (ivermectin) for Cats.
141-079EPRINEX (eprinomectin) Pour-On for Beef and Dairy Cattle.
141-097BMD (bacitracin methylendisalicylate)/IVOMEC (ivermectin) Premix for Swine.
141-123GASTROGARD (omeprazole).
141-188MARQUIS (ponazuril) Antiprotozoal Oral Paste.
141-214ZIMECTERIN Gold (ivermectin and praziquantel) Paste.
141-227ULCERGARD (omeprazole).
141-230PREVICOX (firocoxib) Chewable Tablets.
141-253EQUIOXX (firocoxib) Oral Paste.
141-313EQUIOXX (firocoxib) Injection.
141-327LONGRANGE (eprinomectin) Injection.
141-328ZACTRAN (gamithromycin) Injectable Solution.
141-406NEXGARD (afoxolaner) Chewable Tablet.
141-421DUOCARE (ivermectin and praziquantel) Paste.
141-458EQUIOXX (firocoxib) Tablets.
141-492CENTRAGARD (eprinomectin and praziquantel) Solution.
200-564Ivermectin Paste 1.87%.

Following this change of sponsorship, Merial, Inc., 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 provided in the regulatory text, the animal drug regulations are amended to reflect these changes of sponsorship.

IV. Withdrawals of Approval

Boehringer Ingelheim Animal Health USA, Inc., 3239 Satellite Blvd., Duluth, GA 30096, has requested that FDA withdraw approval of newly transferred NADA 141-054 for use of LINCOMIX (lincomycin hydrochloride) plus IVOMEC (ivermectin) Type A medicated articles to manufacture 2-way, combination drug Type C medicated feed for swine because the product is no longer manufactured or marketed.

Also, Elanco US Inc., 2500 Innovation Way, Greenfield, IN 46140, has requested that FDA withdraw approval of NADA 141-337 for use of RECOVYRA (fentanyl) Transdermal Solution for Dogs because the product is no longer manufactured or marketed.

Elsewhere in this issue of the Federal Register, FDA gave notice that approval of NADAs 141-054 and 141-337, and all supplements and amendments thereto, is withdrawn effective August 19, 2019. As provided in the regulatory text of this document, the animal drug regulations are amended to reflect these actions.

V. Technical Amendments

FDA is removing “IDEXX Pharmaceuticals, Inc.” from the list of sponsors of approved applications in § 510.600(c). This action is being taken to improve the accuracy of the regulations.

In addition, we are reformatting the regulations to present the approved conditions of use of famphur, morantel, and thiabendazole in tabular format in the respective named sections of subpart B of part 558. This action is being taken to improve the readability and consistency of the regulations.

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 Start Printed Page 39182U.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, and 524

  • Animal drugs

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, 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:

End Amendment Part Start Amendment Part

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

End Amendment Part Start Amendment Part

i. Add an entry in alphabetical order for “American Regent, Inc.”;

End Amendment Part Start Amendment Part

ii. Revise the entries for “Aurora Pharmaceutical, LLC”, “Boehringer Ingelheim Vetmedica, Inc.”;

End Amendment Part Start Amendment Part

iii. Remove the entries for “IDEXX Pharmaceuticals, Inc.”, “Luitpold Pharmaceuticals, Inc.”, and “Merial, Inc.”; and

End Amendment Part Start Amendment Part

iv. Revise the entry for “Pharmgate, LLC”; and

End Amendment Part Start Amendment Part

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

End Amendment Part Start Amendment Part

i. Revise the entries for “000010” and “010797”;

End Amendment Part Start Amendment Part

ii. Remove the entry for “050604”;

End Amendment Part Start Amendment Part

iii. Revise the entry for “051072”;

End Amendment Part Start Amendment Part

iv. Remove the entry for “065274”; and

End Amendment Part Start Amendment Part

v. Revise the entry for “069254”.

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
*         *         *         *         *         *         *
American Regent, Inc., Animal Health Division, Shirley, NY 11967010797
*         *         *         *         *         *         *
Aurora Pharmaceutical, Inc., 1196 Highway 3 South, Northfield, MN 55057-3009051072
*         *         *         *         *         *         *
Boehringer Ingelheim Animal Health USA, Inc., 3239 Satellite Blvd., Duluth, GA 30096000010
*         *         *         *         *         *         *
Pharmgate, Inc., 1800 Sir Tyler Dr., Wilmington, NC 28405069254
*         *         *         *         *         *         *

(2) * * *

Drug labeler codeFirm name and address
000010Boehringer Ingelheim Animal Health USA, Inc., 3239 Satellite Blvd., Duluth, GA 30096.
*         *         *         *         *         *         *
010797American Regent, Inc., Animal Health Division, Shirley, NY 11967.
*         *         *         *         *         *         *
051072Aurora Pharmaceutical, Inc., 1196 Highway 3 South, Northfield, MN 55057-3009.
*         *         *         *         *         *         *
069254Pharmgate, Inc., 1800 Sir Tyler Dr., Wilmington, NC 28405.
*         *         *         *         *         *         *
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
[Amended]
Start Amendment Part

4. In § 520.43, in paragraph (b), remove “050604” and in its place add “000010”.

End Amendment Part
[Amended]
Start Amendment Part

5. In § 520.284a, in paragraph (b), remove “050604” and in its place add “000010”.

End Amendment Part
[Amended]
Start Amendment Part

6. In § 520.284b, in paragraph (b), remove “050604” and in its place add “000010”.

End Amendment Part
[Amended]
Start Amendment Part

7. In § 520.284c, in paragraph (b), remove “050604” and in its place add “000010”.

End Amendment Part Start Printed Page 39183 Start Amendment Part

8. Revise § 520.420 to read as follows:

End Amendment Part
Chlorothiazide.

(a) Specifications—(1) Each tablet contains 0.25 grams chlorothiazide.

(2) Each bolus contains 2 grams chlorothiazide.

(b) Sponsor. See No. 000010 in § 510.600(c) of this chapter.

(c) Conditions of use—(1) Dogs—(i)—Amount. Administer 5 to 10 milligrams per pound of body weight two or three times daily.

(ii) Indications for use. For treatment of congestive heart failure and renal edema.

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

(2) Cows—(i)—Amount. Administer 2 grams once or twice daily for 3 or 4 days.

(ii) Indications for use. As an aid in reduction of postparturient udder edema.

(iii) Limitations. Milk taken from dairy animals during treatment and for 72 hours (six milkings) after latest treatment must not be used for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[Amended]
Start Amendment Part

9. In § 520.462, in paragraph (b), remove “050604” and in its place add “000010”.

End Amendment Part
[Amended]
Start Amendment Part

10. In § 520.538, in paragraph (b), remove “No. 058198” and in its place add “Nos. 013744 and 058198”.

End Amendment Part
[Amended]
Start Amendment Part

11. In § 520.804, in paragraph (b), remove “050604” and in its place add “000010”.

End Amendment Part
[Amended]
Start Amendment Part

12. In § 520.928, in paragraph (b), remove “050604” and in its place add “000010”.

End Amendment Part
[Amended]
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13. In § 520.930, in paragraph (b), remove “050604” and in its place add “000010”.

End Amendment Part
[Amended]
Start Amendment Part

14. In § 520.1192, in paragraph (b)(1), remove “050604” and in its place add “000010”.

End Amendment Part
[Amended]
Start Amendment Part

15. In § 520.1193, in paragraph (b)(1), remove “050604” and in its place add “000010”.

End Amendment Part
[Amended]
Start Amendment Part

16. In § 520.1195, in paragraph (b)(1), remove “000859, 050604,” and in its place add “000010, 000859,”; and in paragraph (b)(3), remove “050604” and in its place add “000010”.

End Amendment Part
[Amended]
Start Amendment Part

17. In § 520.1196, in paragraph (b), remove “050604” and in its place add “000010”.

End Amendment Part
[Amended]
Start Amendment Part

18. In § 520.1197, in paragraph (b), remove “050604” and in its place add “000010”.

End Amendment Part
[Amended]
Start Amendment Part

19. In § 520.1198, in paragraphs (b)(1) and (3), remove “050604” and in its place add “000010”.

End Amendment Part
[Amended]
Start Amendment Part

20. In § 520.1615, in paragraph (b), remove “050604” and in its place add “000010”.

End Amendment Part
[Amended]
Start Amendment Part

21. In § 520.1696c, in paragraph (b), remove “050604” and in its place add “000010”.

End Amendment Part
[Amended]
Start Amendment Part

22. In § 520.1696d, in paragraph (b), remove “050604” and in its place add “000010”.

End Amendment Part Start Amendment Part

23. In § 520.1760, revise paragraphs (a) and (c)(1) to read as follows:

End Amendment Part
Phenylpropanolamine.

(a) Specifications—(1) Each chewable tablet contains 25, 50, or 75 milligram (mg) phenylpropanolamine hydrochloride.

(2) Each extended-release tablet contains 18, 38, 74, or 145 mg phenylpropanolamine hydrochloride.

* * * * *

(c) * * *

(1) Amount—Administer orally as follows:

(i) Chewable tablet: 2 mg/kg of body weight twice daily.

(ii) Extended-release tablet: 2 to 4 mg/kg of body weight once daily with food.

* * * * *
[Amended]
Start Amendment Part

24. In § 520.1855, in paragraph (b), remove “050604” and in its place add “000010”.

End Amendment Part
[Amended]
Start Amendment Part

25. In § 520.2170, in paragraph (b), remove “050604” and in its place add “000010”.

End Amendment Part
[Amended]
Start Amendment Part

26. In § 520.2380a, in paragraph (b)(2), remove “050604” and in its place add “000010”.

End Amendment Part
[Amended]
Start Amendment Part

27. In § 520.2380b, in paragraph (b), remove “050604” and in its place add “000010”.

End Amendment Part
[Amended]
Start Amendment Part

28. In § 520.2380c, in paragraph (b), remove “050604” and in its place add “000010”.

End Amendment Part
[Amended]
Start Amendment Part

29. In § 520.2380d, in paragraph (b), remove “050604” and in its place add “000010”.

End Amendment Part
[Redesignated as §§ 520.2380f and 520.2380e]
Start Amendment Part

30. Redesignate §§ 520.2380e and 520.2380f as §§ 520.2380f and 520.2380e, respectively.

End Amendment Part
[Amended]
Start Amendment Part

31. In newly redesignated § 520.2380e, in paragraph (b), remove “050604” and in its place add “000010”.

End Amendment Part Start Part

PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

End Part Start Amendment Part

32. 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

33. In § 522.144, in paragraph (b), remove “050604” and in its place add “000010”.

End Amendment Part Start Amendment Part

34. In § 522.313b, revise paragraphs (a), (b), and (e)(2)(iii) to read as follows:

End Amendment Part
Ceftiofur hydrochloride.

(a) Specifications. Each milliliter of suspension contains:

(1) Ceftiofur hydrochloride equivalent to 50 milligrams (mg) of ceftiofur equivalents in the inactive vehicles phospholipan 90H, sorbitan monooleate, and cottonseed oil;

(2) Ceftiofur hydrochloride equivalent to 50 mg ceftiofur equivalents in the inactive vehicle miglyol oil 812; or

(3) Ceftiofur hydrochloride equivalent to 50 mg ceftiofur equivalents in the inactive vehicles aluminum monostearate, sorbitan monooleate, and medium chain triglycerides.

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

(1) No. 054771 for products described in paragraphs (a)(1) and (2) of this section; andStart Printed Page 39184

(2) No. 055529 for the product described in paragraph (a)(3) of this section.

* * * * *

(e) * * *

(2) * * *

(iii) Limitations—(A) For products described in paragraphs (a)(2) and (3) of this section: Treated cattle must not be slaughtered for 3 days following the last treatment. For products described in paragraph (a)(2) of this section: Treated cattle must not be slaughtered for 4 days following the last treatment.

(B) A withdrawal period has not been established in preruminating calves. Do not use in calves to be processed for veal.

[Amended]
Start Amendment Part

35. In § 522.814, in paragraph (b), remove “050604” and in its place add “000010”.

End Amendment Part
[Amended]
Start Amendment Part

36. In § 522.850, in paragraph (b), remove “050604” and in its place add “000010”.

End Amendment Part
[Amended]
Start Amendment Part

37. In § 522.930, in paragraph (b), remove “050604” and in its place add “000010”.

End Amendment Part
[Amended]
Start Amendment Part

38. In § 522.1014, in paragraph (b), remove “050604” and in its place add “000010”.

End Amendment Part
[Amended]
Start Amendment Part

39. In § 522.1077, in paragraph (b)(4), remove “050604” and in its place add “000010”.

End Amendment Part
[Amended]
Start Amendment Part

40. In § 522.1145, in paragraph (e)(2)(i), remove “050604” and in its place add “000010”.

End Amendment Part
[Amended]
Start Amendment Part

41. In § 522.1150, in paragraph (b), remove “050604” and in its place add “000010”.

End Amendment Part Start Amendment Part

42. In § 522.1160, revise paragraphs (b)(1) and (2); redesignate the text of paragraph (c)(1)(i) as paragraph (c)(1)(i)(A); add a paragraph heading to newly redesignated paragraph (c)(1)(i)(A); and add paragraph (c)(1)(i)(B).

End Amendment Part

The revision and addition read as follows:

Insulin.
* * * * *

(b) * * *

(1) No. 000061 for use of product described in paragraph (a)(1) as in paragraphs (c)(1)(i)(A), (c)(1)(ii), (c)(1)(iii), (c)(2)(i)(A), (c)(2)(ii), and (c)(2)(iii) of this section.

(2) No. 000010 for use of product described in paragraph (a)(2) as in paragraphs (c)(1)(i)(B), (c)(1)(ii), (c)(1)(iii), (c)(2)(i)(B), (c)(2)(ii), and (c)(2)(iii) of this section.

(c) * * *

(1) * * *

(i) * * *

(A) Porcine zinc insulin zinc. * * *

(B) Protamine zinc recombinant human insulin. Administer a starting dose of 0.2 to 0.5 IU/pound of body weight (0.5 to 1.0 IU/kg) once daily. When transitioning from another insulin product, this form of insulin should be started once daily, regardless of the frequency of prior insulin use. The dose should be given concurrently with or right after a meal. Reevaluate the dog at appropriate intervals and adjust the dose based on both clinical signs and laboratory test results until adequate glycemic control has been attained. Twice-daily therapy should be initiated if the duration of insulin action is determined to be inadequate. If twice-daily treatment is initiated, the two doses should be 25 percent less than the once daily dose required to attain an acceptable nadir.

* * * * *
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43. In § 522.1192, in paragraph (b)(1), remove “050604” and in its place add “000010”.

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44. In § 522.1193, revise paragraphs (b) and (e)(3) to read as follows:

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Ivermectin and clorsulon.
* * * * *

(b) Sponsors. See Nos. 000010, 055529, 058005, and 061133 in § 510.600(c) of this chapter.

* * * * *

(e) * * *

(3) Limitations—(i) Nos. 000010 and 061133: Do not treat cattle within 21 days of slaughter. Nos. 055529 and 058005: Do not treat cattle within 49 days of slaughter.

(ii) Because a withdrawal time in milk has not been established, do not use in female dairy cattle of breeding age. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.

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45. In § 522.1362, in paragraph (b), remove “050604” and in its place add “000010”.

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46. In § 522.1452, in paragraph (b), remove “050604” and in its place add “000010”.

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47. In § 522.1885, in paragraph (b), remove “050604” and in its place add “000010”.

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PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

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

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

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49. In § 524.814, in paragraph (b), remove “050604” and in its place add “000010”.

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50. In § 524.815, in paragraph (b), remove “050604” and in its place add “000010”.

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51. Effective August 19, 2019, remove § 524.916.

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52. In § 524.1193, in paragraph (b)(1), remove “050604” and in its place add “000010”.

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53. In § 524.1484g, in paragraph (b), remove “026637 and 050604” and in its place add “000010 and 026637”.

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54. In § 524.1484j, in paragraph (b), remove “050604” and in its place add “000010”.

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55. In § 524.2101, in paragraph (b), remove “000061, 017135, and 050604” and in its place add “000010, 000061, and 017135”.

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PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

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

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

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57. In § 558.58, redesignate paragraphs (e)(3) through (6) as paragraphs (e)(2) through (5), and redesignate paragraph (e)(9) as new paragraph (e)(6).

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58. In § 558.76, redesignate paragraphs (e)(1)(ix) through (xvi) as paragraphs (e)(1)(vii) through (xiv).

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59. In § 558.128, revise paragraphs (b)(1) and (e)(4)(xv), redesignate paragraphs (e)(4)(xvi) through (xxvi) as paragraphs (e)(4)(xvii) through (xxvii), and add new paragraph (e)(4)(xvi).

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The revisions and addition read as follows:

Chlortetracycline.
* * * * *

(b) * * *

(1) No. 054771: 50, 70, 80, 90, or 100 grams per pound (g/lb) Type A medicated article.

* * * * *

(e) * * *

(4) * * *

Chlortetracycline amountCombination in grams/tonIndications for useLimitationsSponsor
*         *         *         *         *         *         *
(xv) 350 mg/head/day1. Beef cattle: For control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetracyclineTo sponsor No. 054771 under NADAs 046-699 and 049-287, No. 066104 under NADA 092-286, and No. 069254 under NADA 048-480: Withdraw 48 hours prior to slaughter. To sponsor No. 069254 under NADA 138-935 and ANADA 200-510: Zero withdrawal period*
2. Beef cattle (under 700 lb): For control of active infection of anaplasmosis caused by A. marginale susceptible to chlortetracyclineTo sponsor No. 054771 under NADAs 046-699 and 049-287, No. 066104 under NADA 092-286, and No. 069254 under NADA 048-480: Withdraw 48 h prior to slaughter. To sponsor No. 054771 under NADA 048-761 and No. 069254 under NADA 138-935 and ANADA 200-510: Zero withdrawal time*
(xvi) 20 to 350 g/tonBeef cattle and replacement dairy heifers: For control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetracyclineFeed to provide chlortetracycline at the rate of 350 mg per head per day. This drug is not approved for use in female dairy cattle 20 months of age or older, including dry dairy cows. Use in these cattle may cause drug residues in milk and/or in calves born to these cows. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. To sponsor No. 054771 under NADA 048-761: Zero withdrawal period054771
*         *         *         *         *         *         *
* * * * *
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60. Effective September 9, 2019, in § 558.235, in paragraph (b), remove “050604” and in its place add “000010”.

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61. Revise § 558.254 to read as follows:

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Famphur.

(a) Specifications. Type A medicated articles containing 13.2 or 33.3 percent famphur.

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

(c) Related tolerances. See § 556.273 of this chapter.

(d) Special considerations. Famphur is a cholinesterase inhibitor. Do not use this product in animals simultaneously or within a few days before or after treatment with or exposure to cholinesterase-inhibiting drugs, pesticides, or chemicals.

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

Table 2—Size Proxies for SRCs in 2016

Famphur in grams/tonIndications for useLimitationsSponsor
(i) 1.1 milligrams per pound (mg/lb) body weight per dayBeef cattle and nonlactating dairy cows: For control of grubs and as an aid in control of sucking liceFeed for 30 days. Withdraw from dry dairy cows and heifers 21 days prior to freshening. Withdraw 4 days prior to slaughter000061
(ii) 2.3 mg/lb body weight per dayBeef cattle and nonlactating dairy cows: For control of grubsFeed for 10 days. Withdraw from dry dairy cows and heifers 21 days prior to freshening. Withdraw 4 days prior to slaughter000061
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62. In § 558.300, in paragraph (b), remove “050604” and in its place add “No. 000010”; in paragraphs (e)(1) through (6), in the “Sponsor” column, remove “050604” and in its place add “000010”; and remove paragraph (f).

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63. Effective August 19, 2019, in § 558.325, remove paragraphs (e)(2)(iii), (x), and (xvi); and redesignate paragraphs (e)(2)(iv) through (ix) as paragraphs (e)(2)(iii) through (viii), paragraphs (e)(2)(xi) through (xv) as paragraphs (e)(2)(ix) through (xiii), and paragraph (e)(2)(xvii) as paragraph (e)(2)(xiv).

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64. Revise § 558.360 to read as follows:

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Morantel.

(a) Specifications. Each pound of Type A medicated article contains 88 grams morantel tartrate.

(b) Sponsor. See No. 066104 in § 510.600(c) of this chapter.

(c) Related tolerances. See § 556.425 of this chapter.

(d) Special considerations—(1) Do not use in Type B or Type C medicated feeds containing bentonite.Start Printed Page 39186

(2) Consult your veterinarian before using in severely debilitated animals and for assistance in the diagnosis, treatment, and control of parasitism.

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

Morantel tartrate in grams/tonIndications for useLimitationsSponsor
(1) 0.44 to 4.4 grams of morantel tartrate per pound of feedCattle: For removal and control of mature gastrointestinal nematode infections of cattle including stomach worms (Haemonchus spp., Ostertagia spp., Trichostrongylus spp.), worms of the small intestine (Cooperia spp., Trichostrongylus spp., Nematodirus spp.), and worms of the large intestine (Oesophagostomum radiatum)Feed as a single therapeutic treatment at 0.44 gram of morantel tartrate per 100 pounds of body weight. Fresh water should be available at all times. When medicated feed is consumed, resume normal feeding. Conditions of constant worm exposure may require retreatment in 2 to 4 weeks. Do not treat cattle within 14 days of slaughter066104
(2) 0.44 to 4.4 grams of morantel tartrate per pound of feedGoats: For removal and control of mature gastrointestinal nematode infections of goats including Haemonchus contortus, Ostertagia (Teladorsagia) circumcincta, and Trichostrongylus axeiFeed as a single therapeutic treatment at 0.44 gram of morantel tartrate per 100 pounds of body weight. Fresh water should be available at all times. When medicated feed is consumed, resume normal feeding. Conditions of constant worm exposure may require retreatment in 2 to 4 weeks. Do not treat goats within 30 days of slaughter066104
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65. Revise § 558.600 to read as follows:

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Thiabendazole.

(a) Specifications. Dry Type A medicated articles containing 22, 44.1, 66.1, or 88.2 percent thiabendazole. The 66.1 percent Type A medicated article is solely for the manufacture of cane molasses liquid Type B feed, which is mixed in dry feeds. The 88.2 percent Type A medicated article is used solely for the manufacture of an aqueous slurry for adding to a Type C dry cattle feed.

(b) Sponsor. See No. 000010 in § 510.600(c) of this chapter.

(c) Related tolerances. See § 556.730 of this chapter.

(d) Special considerations. Do not use in Type B or Type C medicated feed containing bentonite.

(e) Conditions of use. It is used in feed for animals as follows:

(1) Swine

Thiabendazole in grams/tonIndications for useLimitationsSponsor
(i) 45.4 to 908 (0.005 to 0.1 percent)Swine: As an aid in the prevention of infections of large roundworms (genus Ascaris)Administer continuously in feed containing 0.05 to 0.1 percent thiabendazole per ton for 2 weeks followed by feed containing 0.005 to 0.02 percent thiabendazole per ton for 8 to 14 weeks. Do not treat animals within 30 days of slaughter000010
(ii) [Reserved]

(2) Cattle

Thiabendazole amountIndications for useLimitationsSponsor
(i) 3 grams per 100 lb. body weightFor control of infections of gastrointestinal roundworms (Trichostrongylus spp., Haemonchus spp., Ostertagia spp., Nematodirus spp., Oesophagostomum radiatum)Use 3 grams per 100 lb. body weight at a single dose; may repeat once in 2 to 3 weeks. Do not treat animals within 3 days of slaughter. Milk taken from treated animals within 96 hours (8 milkings) after the latest treatment must not be used for food000010
(ii) 5 grams per 100 lb. body weightFor control of severe infections of gastrointestinal roundworms (Trichostrongylus spp., Haemonchus spp., Ostertagia spp., Nematodirus spp., Oesophagostomum radiatum); control of infections of Cooperia sppUse 5 grams per 100 lb. body weight at a single dose or divided into 3 equal doses, administered 1 dose each day, on succeeding days. May repeat once in 2 to 3 weeks. Do not treat animals within 3 days of slaughter. Milk taken from treated animals within 96 hours (8 milkings) after the latest treatment must not be used for food000010

(3) Minor speciesStart Printed Page 39187

Thiabendazole amountIndications for useLimitationsSponsor
(i) 2 grams per 100 lb. body weightSheep and goats: For control of infections of gastrointestinal roundworms (Trichostrongylus spp., Haemonchus spp., Ostertagia spp., Cooperia spp.; Nematodirus spp., Bunostomum spp., Strongyloides spp., Chabertia spp., and Oesophagostomum spp.); also active against ova and larvae passed by sheep from 3 hours to 3 days after the feed is consumed (good activity against ova and larvae of T. colubriformis and axei, Ostertagia spp., Nematodirus spp., Strongyloides spp.; less effective against those of Haemonchus contortus and Oesophagostomum spp.)Use 2 grams per 100 lb. body weight at a single dose. Do not treat animals within 30 days of slaughter. Milk taken from treated animals within 96 hours (8 milkings) after the latest treatment must not be used for food050604
(ii) 3 grams per 100 lb. body weightGoats: For control of severe infections of gastrointestinal roundworms (Trichostrongylus spp., Haemonchus spp., Ostertagia spp., Cooperia spp., Nematodirus spp., Bunostomum spp., Strongyloides spp., Chabertia spp., and Oesophagostomum spp.)Use 3 grams per 100 lb. body weight at a single dose. Do not treat animals within 30 days of slaughter. Milk taken from treated animals within 96 hours (8 milkings) after the latest treatment must not be used for food050604
(iii) 454 grams per ton of feedPheasants: For the treatment of gapeworms (Syngamus trachea)Feed continuously for 2 weeks (14 days). Do not use treated pheasants for food for 21 days after last day of treatment. Fertility, hatchability, and other reproductive data are not available on use in breeding animals050604
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Dated: August 1, 2019.

Lowell J. Schiller,

Principal Associate Commissioner for Policy.

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[FR Doc. 2019-16884 Filed 8-8-19; 8:45 am]

BILLING CODE 4164-01-P