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Oral Dosage Form New Animal Drugs; Approval of New Animal Drug Applications

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Start Preamble Start Printed Page 94987

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule; technical amendment.

SUMMARY:

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of 43 supplemental new animal drug applications (NADAs) and 52 supplemental abbreviated new animal drug applications (ANADAs) for revised labeling reflecting a change in marketing status from over-the-counter (OTC) to prescription (Rx) for antimicrobial drugs of importance to human medicine administered to food-producing animals in medicated drinking water. These applications were submitted in voluntary compliance with the goals of the FDA Center for Veterinary Medicine's (CVM's) Judicious Use Initiative.

DATES:

This rule is effective December 31, 2016.

Start Further Info

FOR FURTHER INFORMATION CONTACT:

George K. Haibel, Center for Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5689, george.haibel@fda.hhs.gov.

End Further Info End Preamble Start Supplemental Information

SUPPLEMENTARY INFORMATION:

FDA is amending the animal drug regulations to reflect approval of 43 supplemental NADAs and 52 supplemental ANADAs for revised labeling reflecting a change in marketing status from OTC to Rx for antimicrobial drugs of importance to human medicine administered to food-producing animals in medicated drinking water. These applications were identified as being affected by guidance for industry (GFI) #213, “New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions with GFI #209,” December 2013 (http://www.fda.gov/​downloads/​AnimalVeterinary/​GuidanceComplianceEnforcement/​GuidanceforIndustry/​UCM299624.pdf). Their change to Rx marketing status is consistent with the FDA CVM's initiative for the Judicious Use of Antimicrobials. The affected applications follow:

File No.Animal drug productSponsor
006-084SULMET (sulfamethazine) Drinking Water SolutionHuvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str., 1113 Sophia, Bulgaria (Huvepharma EOOD).
006-677S.Q. (sulfaquinoxaline) 20% SolutionHuvepharma EOOD.
006-707SULQUIN 6-50 (Sulfaquinoxaline)Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007 (Zoetis Inc.).
006-891SUL-Q-NOX (sulfaquinoxaline) SolutionHuvepharma EOOD.
007-087Sulfaquinoxaline Solubilized (Powder)Huvepharma EOOD.
008-622TERRAMYCIN (oxytetracycline) Soluble PowderZoetis Inc.
011-315NEOMIX 325 (neomycin) Soluble PowderZoetis Inc.
015-160Sodium Sulfachloropyrazine SolutionZoetis Inc.
031-205AGRIBON (sulfadimethoxine) 12.5% Drinking Water SolutionZoetis Inc.
031-553ESB 3 (sulfachloropyrazine) Soluble Powder/SolutionZoetis Inc.
032-946MAGNA TERRAMYCIN (oxytetracycline and carbomycin) Soluble PowderZoetis Inc.
033-373VETSULID SP (sulfachloropyridazine) Soluble PowderHuvepharma EOOD.
035-157GALLIMYCIN (erythromycin) Soluble PowderCross Vetpharm Group Ltd., Broomhill Rd., Tallaght, Dublin 24, Ireland (Cross Vetpharm Group Ltd.).
038-200MEDAMYCIN (oxytetracycline) Soluble PowderPhibro Animal Health Corp., GlenPointe Centre East, 3d floor, 300 Frank W. Burr Blvd., suite 21, Teaneck, NJ 07666 (Phibro Animal Health Corp.).
038-661SPECTOGARD (spectinomycin) Water Soluble PowderCross Vetpharm Group Ltd.
046-109L-S 50 (lincomycin and spectinomycin) Water Soluble PowderZoetis Inc.
046-285AGRIBON (sulfadimethoxine) Soluble PowderZoetis Inc.
055-012CHLORONEX SULMET (chlortetracycline bisulfate and sulfamethazine) Soluble PowderHuvepharma EOOD.
055-020AUREOMYCIN (chlortetracycline) Soluble PowderZoetis Inc.
055-060Penicillin G Potassium, USPZoetis Inc.
065-071AUREOMYCIN (chlortetracycline) Soluble PowderHuvepharma EOOD.
065-123Tetracycline Soluble PowderZoetis Inc.
065-140TET-SOL 324 (tetracycline) Soluble PowderHuvepharma EOOD.
065-178FERMYCIN (chlortetracycline) SolublePhibro Animal Health Corp.
065-256CHLORO-SOLUBLE-O (chlortetracycline) Soluble PowderPharmgate LLC, 1015 Ashes Dr., suite 102, Wilmington, NC 28405 (Pharmgate LLC).
065-269POLYOTIC (tetracycline) Soluble PowderHuvepharma EOOD.
065-410TETRA-SAL (tetracycline) Soluble PowderZoetis Inc.
065-440CHLORONEX (chlortetracycline) Soluble PowderHuvepharma EOOD.
065-441POLYOTIC (tetracycline) Soluble Powder ConcentrateZoetis Inc.
065-480Chlortetracycline Soluble PowderPharmgate LLC.
065-486Chlortetracycline Bisulfate Soluble PowderStrategic Veterinary Pharmaceuticals, Inc., 100 NW. Airport Rd., St. Joseph, MO 64503 (Strategic Vet. Pharm., Inc.).
065-496Tetracycline Soluble PowderPhibro Animal Health Corp.
091-191GENTOCIN (gentamicin) Oral SolutionIntervet, Inc., 2 Giralda Farms, Madison, NJ 07940 (Intervet, Inc.).
100-094POULTRY SULFA (sulfamerazine, sulfamethazine, and sulfaquinoxaline) Soluble PowderHuvepharma EOOD.
106-964APRALAN (apramycin) Soluble PowderElanco US Inc.
111-636LINCOMIX (lincomycin) Soluble PowderZoetis Inc.
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122-272SULMET (sulfamethazine) Soluble PowderHuvepharma EOOD.
130-435OXY-TET (oxytetracycline) Soluble PowderHuvepharma EOOD.
133-836GARACIN (gentamicin) Soluble PowderIntervet, Inc.
140-578SOLU-TET 324 (tetracycline) Soluble PowderZoetis Inc.
200-026PENNOX 343 (oxytetracycline)Pharmgate LLC.
200-030Sulfadimethoxine 12.5% Oral SolutionAgri Laboratories, Ltd., P.O. Box 3103, St. Joseph, MO 64503 (Agri Laboratories, Ltd.).
200-031Sulfadimethoxine Antibacterial Soluble PowderAgri Laboratories, Ltd.
200-046Neomycin Soluble PowderZoetis Inc.
200-049Tetracycline Hydrochloride Soluble Powder-324Agri Laboratories, Ltd.
200-050NEOMED (neomycin) Soluble PowderCross Vetpharm Group Ltd.
200-066AGRIMYCIN-343 (oxytetracycline) Soluble PowderAgri Laboratories, Ltd.
200-103PENAQUA SOL-G (penicillin G potassium) Soluble PowderCross Vetpharm Group Ltd.
200-106R-PEN (penicillin G potassium) Soluble PowderHuvepharma EOOD.
200-113BIOSOL® (neomycin) LiquidZoetis Inc.
200-118Neomycin Oral SolutionHuvepharma EOOD.
200-122SOLU-PEN (penicillin G potassium) Soluble PowderZoetis Inc.
200-130NEO-SOL 50 (neomycin) Soluble PowderZoetis Inc.
200-136Tetracycline Hydrochloride Soluble Powder-324Quo Vademus, LLC, 277 Faison McGowan Rd., Kenansville, NC 28349 (Quo Vademus, LLC).
200-144Oxytetracycline HCl Soluble PowderCross Vetpharm Group Ltd.
200-146TETROXY 25 (oxytetracycline)Cross Vetpharm Group Ltd.
200-153NEO 200 (neomycin) Oral SolutionHuvepharma EOOD.
200-165SDM (sulfadimethoxine) 12.5% Oral SolutionStrategic Vet. Pharm., Inc.
200-185GEN-GARD (Gentamicin sulfate) Soluble PowderAgri Laboratories, Ltd.
200-189Lincomycin SolubleHuvepharma EOOD.
200-190GENTORAL (gentamicin sulfate) Oral SolutionMed-Pharmex, Inc., 2727 Thompson Creek Rd., Pomona, CA 91767-1861 (Med-Pharmex, Inc.).
200-192Sulfadimethoxine 12.5% Oral SolutionHuvepharma EOOD.
200-197Streptomycin Oral Solution w/STREP SOL (RLNAD 065-252)Huvepharma EOOD.
200-233LINCO (lincomycin) Soluble PowderZoetis Inc.
200-234TETRASOL (tetracycline) Soluble PowderMed-Pharmex, Inc.
200-235NEOSOL (neomycin) Soluble PowderMed-Pharmex, Inc.
200-236Chlortetracycline HCL Soluble PowderQuo Vademus, LLC.
200-238SULFASOL (sulfadimethoxine) Soluble PowderMed-Pharmex, Inc.
200-241LINCOSOL (lincomycin) Soluble PowderMed-Pharmex, Inc.
200-247TETROXY 343 (oxytetracycline) Soluble PowderCross Vetpharm Group Ltd.
200-251SULFORAL (Sulfadimethoxine) Soluble PowderMed-Pharmex, Inc.
200-258Sulfadimethoxine Soluble PowderPhibro Animal Health Corp.
200-289NEOSOL-ORAL (neomycin) Soluble PowderMed-Pharmex, Inc.
200-295PENNCHLOR 64 (chlortetracycline) Soluble PowderPharmgate LLC.
200-303Lincomycin Hydrochloride Soluble PowderQuo Vademus, LLC.
200-345Lincomycin-Spectinomycin Soluble PowderPhibro Animal Health Corp.
200-347Penicillin G Potassium USPQuo Vademus, LLC.
200-372HAN-PEN (penicillin G potassium) Soluble PowderG.C. Hanford Manufacturing Co., P.O. Box 1017, Syracuse, NY 13201 (G.C. Hanford Mfg. Co.).
200-374TETRAMED 324 HCA (tetracycline) Soluble PowderCross Vetpharm Group Ltd.
200-376SULFAMED-G (sulfadimethoxine) Soluble PowderCross Vetpharm Group Ltd.
200-377LINXMED-SP (lincomycin and spectinomycin) Soluble PowderCross Vetpharm Group Ltd.
200-378Neomycin Sulfate 325 Soluble PowderSparhawk Laboratories, Inc., 12340 Santa Fe Trail Dr., Lenexa, KS 66215 (Sparhawk Laboratories, Inc.).
200-379Neomycin LiquidSparhawk Laboratories, Inc.
200-380SPECLINX-50 (lincomycin and spectinomycin) Soluble PowderCross Vetpharm Group Ltd.
200-407Lincomycin-Spectinomycin Water Soluble PowderAgri Laboratories, Ltd.
200-434SMZ-MED 454 (sulfamethazine) Soluble PowderCross Vetpharm Group Ltd.
200-441AUREOMYCIN (chlortetracycline) Soluble PowderHuvepharma EOOD.
200-443Sulfadimethoxine Soluble PowderFirst Priority, Inc., 1590 Todd Farm Dr., Elgin, IL 60123.
200-460TETROXY AQUATIC (oxytetracycline) Soluble PowderCross Vetpharm Group Ltd.
200-494GENTAMED (gentamicin) Soluble PowderCross Vetpharm Group Ltd.

The animal drug regulations are also being amended to reflect several non-substantive changes in format. These technical amendments are being made to improve the consistency and readability of the regulations.

Elsewhere in this issue of the Federal Register, FDA is amending the animal drug regulations to reflect approval of similar supplemental NADAs and ANADAs changing the marketing status of antimicrobial drugs administered to food-producing animals in medicated feed.

This rule 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.

Start List of Subjects

List of Subjects in 21 CFR Parts 520 and 529

  • Animal drugs
End List of Subjects

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR parts 520 and 529 are amended as follows:

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PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS

End Part Start Amendment Part

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

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

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[Amended]
Start Amendment Part

2. In § 520.110, in paragraph (d)(3), remove “Prepare fresh medicated water daily.” and as the last sentence add “Federal law restricts this drug to use by or on the order of a licensed veterinarian.”

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[Amended]
Start Amendment Part

3. In § 520.441, in paragraphs (d)(1)(i)(A)( 2), (d)(2)(i)(A)(2), (d)(4)(i)(A)(2), (d)(4)(i)(B)(2), (d)(4)(ii)(A)(2), (d)(4)(ii)(B)(2), (d)(4)(iii)(C), (d)(4)(iv)(C), (d)(5)(i)(A)(2), (d)(5)(ii)(A)(2), (d)(5)(iii)(C), and (d)(5)(iv)(C), as the last sentence add “Federal law restricts this drug to use by or on the order of a licensed veterinarian.”

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[Amended]
Start Amendment Part

4. In § 520.445, in paragraph (d)(3), as the last sentence add “Federal law restricts this drug to use by or on the order of a licensed veterinarian.”

End Amendment Part Start Amendment Part

5. In § 520.823, revise paragraphs (d)(1)(i), (d)(1)(iii), (d)(2)(i), (d)(2)(iii), (d)(3)(i), and (d)(3)(iii) to read as follows:

End Amendment Part
Erythromycin.
* * * * *

(d) * * *

(1) * * *

(i) Amount. Administer 0.500 gram per gallon for 5 days.

* * * * *

(iii) Limitations. Do not use in replacement pullets over 16 weeks of age. Do not use in chickens producing eggs for human consumption. Withdraw 1 day before slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) * * *

(i) Amount. Administer 0.500 gram per gallon for 7 days.

* * * * *

(iii) Limitations. Do not use in replacement pullets over 16 weeks of age. Do not use in chickens producing eggs for human consumption. Withdraw 1 day before slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(3) * * *

(i) Amount. Administer 0.500 gram per gallon for 7 days.

* * * * *

(iii) Limitations. Do not use in turkeys producing eggs for human consumption. Withdraw 1 day before slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Start Amendment Part

6. In § 520.1044a, revise paragraph (d)(3) to read as follows:

End Amendment Part
Gentamicin sulfate oral solution.
* * * * *

(d) * * *

(3) Limitations. Do not slaughter treated swine for food for at least 3 days following treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Start Amendment Part

7. In § 520.1044c, remove paragraph (d)(4) and revise paragraph (d)(3) to read as follows:

End Amendment Part
Gentamicin sulfate powder.
* * * * *

(d) * * *

(3) Limitations. Withdrawal period: 10 days. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[Amended]
Start Amendment Part

8. In § 520.1263c, in paragraph (b)(1), remove “No. 016592” and in its place add “Nos. 016592 and 054771”; in paragraph (d)(1)(iii), remove “051259” and in its place add “054925”, and as the last sentence add “Federal law restricts this drug to use by or on the order of a licensed veterinarian.”; and in paragraphs (d)(2)(iii) and (d)(3)(iii), add “Federal law restricts this drug to use by or on the order of a licensed veterinarian.”

End Amendment Part Start Amendment Part

9. In § 520.1265, add paragraph (d)(3) to read as follows:

End Amendment Part
Lincomycin and spectinomycin powder.
* * * * *

(d) * * *

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

Start Amendment Part

10. In § 520.1484, revise paragraphs (e)(1)(iii) and (e)(2)(iii) to read as follows:

End Amendment Part
Neomycin.
* * * * *

(e) * * **

(1) * * *

(iii) Limitations. Discontinue treatment prior to slaughter as follows: Cattle, 1 day; sheep, 2 days; swine and goats, 3 days. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) * * *

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

Start Amendment Part

11. In § 520.1660a, revise the section heading and paragraphs (e)(1) and (e)(3) to read as follows:

End Amendment Part
Oxytetracycline and carbomycin.
* * * * *

(e) * * *

(1) Amount. Administer 1.0 gram of oxytetracycline and 1.0 gram carbomycin per gallon for not more than 5 days.

* * * * *

(3) Limitations. Not for use in chickens producing eggs for human consumption. Withdraw 24 hours before slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Start Amendment Part

12. In § 520.1660d, revise paragraphs (d)(1)(i)(A)( 1), (d)(1)(i)(A)(3), (d)(1)(i)(B)(1), (d)(1)(i)(B)(3), (d)(1)(ii)(A)(1), (d)(1)(ii)(A)(3), (d)(1)(ii)(B)(1), (d)(1)(ii)(B)(3), (d)(1)(ii)(C)(1), (d)(1)(ii)(C)(3), (d)(1)(iii)(A), (d)(1)(iii)(C), (d)(1)(iv)(A), (d)(1)(iv)(C), (d)(1)(v)(A), (d)(1)(v)(C), (d)(2)(i), and (d)(2)(iii) to read as follows:

End Amendment Part
Oxytetracycline powder.
* * * * *

(d) * * *

(1) * * *

(i) * * *

(A) * * *

(1) Amount. Administer 200 to 400 milligrams/gallon for 7 to 14 days. Not to be used for more than 14 consecutive days.

* * * * *

(3) Do not use in birds producing eggs for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(B) * * *

(1) Amount. Administer 400 to 800 milligrams/gallon for 7 to 14 days. Not to be used for more than 14 consecutive days.

* * * * *

(3) Do not use in birds producing eggs for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(ii) * * *

(A) * * *

(1) Amount. Administer 200 to 400 milligrams/gallon for 7 to 14 days. Not to be used for more than 14 consecutive days.

* * * * *

(3) Do not use in birds producing eggs for human consumption. Withdraw 5 days prior to slaughter those products sponsored by Nos. 054771 and 061623 in § 510.600(c) of this chapter. Withdraw 4 days prior to slaughter Start Printed Page 94990those products sponsored by No. 054628. Zero-day withdrawal for those products sponsored by Nos. 057561 and 069254. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(B) * * *

(1) Amount. Administer 400 milligrams/gallon for 7 to 14 days. Not to be used for more than 14 consecutive days.

* * * * *

(3) Do not use in birds producing eggs for human consumption. Withdraw 5 days prior to slaughter those products sponsored by Nos. 054771 and 061623 in § 510.600(c) of this chapter. Withdraw 4 days prior to slaughter those products sponsored by No. 054628. Zero-day withdrawal for those products sponsored by Nos. 057561 and 069254. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(C) * * *

(1) Amount. Administer 25 milligrams per pound of body weight daily for 7 to 14 days. Not to be used for more than 14 consecutive days.

* * * * *

(3) Do not use in birds producing eggs for human consumption. Withdraw 5 days prior to slaughter those products sponsored by Nos. 054771 and 061623 in § 510.600(c) of this chapter. Withdraw 4 days prior to slaughter those products sponsored by No. 054628. Zero-day withdrawal for those products sponsored by Nos. 057561 and 069254. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(iii) * * *

(A) Amount. Administer 10 milligrams per pound of body weight daily for up to 14 days. Do not use for more than 14 consecutive days.

* * * * *

(C) Withdraw zero days prior to slaughter those products sponsored by Nos. 054771, 057561, 061623, and 069254 in § 510.600(c) of this chapter. Withdraw 4 days prior to slaughter those products sponsored by No. 054628. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(iv) * * *

(A) Amount. Administer 10 milligrams per pound of body weight daily for up to 14 days. Do not use for more than 14 consecutive days.

* * * * *

(C) Withdraw 5 days prior to slaughter. A milk discard period has not been established for this product in lactating dairy cattle. Do not use in female dairy cattle 20 months of age or older. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(v) * * *

(A) Amount. Administer 10 milligrams per pound of body weight daily for up to 14 days. Not to be used for more than 14 consecutive days.

* * * * *

(C) Withdraw 5 days prior to slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) * * *

(i) Amount. 200 milligrams per colony, administered via either a 1:1 sugar syrup (equal parts of sugar and water weight to weight) or dusting with a powdered sugar mixture. The drug is administered in 3 applications of sugar syrup or 3 dustings at 4- to 5-day intervals.

* * * * *

(iii) The drug should be fed early in the spring or fall and consumed by the bees before main honey flow begins to avoid contamination of production honey. Remove at least 6 weeks prior to main honey flow. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Start Amendment Part

13. In § 520.1696b, redesignate paragraph (c) as paragraph (d) and add new paragraph (c), and revise redesignated paragraph (d)(3) to read as follows:

End Amendment Part
Penicillin G powder.
* * * * *

(c) Related tolerances. See § 556.510 of this chapter.

* * * * *

(d) * * *

(3) Limitations. Discontinue treatment at least 1 day prior to slaughter. Not for use in turkeys producing eggs for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[Amended]
Start Amendment Part

14. In § 520.2123b, remove paragraph (d)(1)(i); redesignate paragraphs (d)(1)(ii) and (iii) as paragraphs (d)(1)(i) and (ii); and in paragraph (d)(2), as the last sentence add “Federal law restricts this drug to use by or on the order of a licensed veterinarian.”

End Amendment Part
[Amended]
Start Amendment Part

15. In § 520.2184, in paragraph (d)(3), remove the first sentence, and as the last sentence add “Federal law restricts this drug to use by or on the order of a licensed veterinarian.”

End Amendment Part
[Amended]
Start Amendment Part

16. In § 520.2200, in paragraphs (d)(1)(iii) and (d)(2)(iii), as the last sentence add “Federal law restricts this drug to use by or on the order of a licensed veterinarian.”

End Amendment Part
[Amended]
Start Amendment Part

17. In § 520.2218, in paragraphs (d)(1)(ii) and (d)(2)(ii), remove the first sentence, and as the last sentence add “Federal law restricts this drug to use by or on the order of a licensed veterinarian.”

End Amendment Part Start Amendment Part

18. In § 520.2220a, revise the section heading and paragraphs (d)(1)(iii), (d)(2)(iii), and (d)(3)(iii) to read as follows:

End Amendment Part
Sulfadimethoxine oral solution and soluble powder.
* * * * *

(d) * * *

(1) * * *

(iii) Limitations. Withdraw 5 days before slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) * * *

(iii) Limitations. Withdraw 5 days before slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(3) * * *

(iii) Limitations. Withdraw 7 days before slaughter. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law prohibits the extralabel use of this product in lactating dairy cattle.

[Amended]
Start Amendment Part

19. In § 520.2261a, in paragraph (d)(3), as the last sentence add “Federal law restricts this drug to use by or on the order of a licensed veterinarian.”

End Amendment Part
[Amended]
Start Amendment Part

20. In § 520.2261b, in paragraphs (d)(1)(iii), (d)(2)(iii), (d)(3)(iii), and (d)(4)(iii), as the last sentence add “Federal law restricts this drug to use by or on the order of a licensed veterinarian.”

End Amendment Part
[Amended]
Start Amendment Part

21. In § 520.2325a, in paragraph (d), remove the first sentence, and as the last sentence add “Federal law restricts this drug to use by or on the order of a licensed veterinarian.”

End Amendment Part
[Amended]
Start Amendment Part

22. In § 520.2345d, in paragraphs (d)(1)(iii), (d)(2)(iii), (d)(3)(iii), and (d)(4)(iii), as the last sentence add “Federal law restricts this drug to use by or on the order of a licensed veterinarian.”

End Amendment Part Start Part Start Printed Page 94991

PART 529—CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

End Part Start Amendment Part

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

End Amendment Part Start Authority

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

End Authority Start Amendment Part

24. In § 529.1660, add paragraph (d)(3) to read as follows:

End Amendment Part
Oxytetracycline.
* * * * *

(d) * * *

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

Start Signature

Dated: December 20, 2016.

Tracey H. Forfa,

Deputy Director, Center for Veterinary Medicine.

End Signature End Supplemental Information

[FR Doc. 2016-31084 Filed 12-23-16; 8:45 am]

BILLING CODE 4164-01-P