Oral Dosage Form New Animal Drugs; Approval of New Animal Drug Applications, 94987-94991 [2016-31084]

Download as PDF Federal Register / Vol. 81, No. 248 / Tuesday, December 27, 2016 / Rules and Regulations DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 520 and 529 [Docket No. FDA–2016–N–0002] Oral Dosage Form New Animal Drugs; Approval of New Animal Drug Applications AGENCY: Food and Drug Administration, HHS. Final rule; technical amendment. ACTION: 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 SUMMARY: 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 foodproducing 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. 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. SUPPLEMENTARY INFORMATION: FDA is amending the animal drug regulations to reflect approval of 43 supplemental NADAs and 52 supplemental ANADAs 94987 for revised labeling reflecting a change in marketing status from OTC to Rx for antimicrobial drugs of importance to human medicine administered to foodproducing 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 (https://www.fda.gov/downloads/ AnimalVeterinary/GuidanceCompliance Enforcement/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: Animal drug product Sponsor 006–084 ...... SULMET (sulfamethazine) Drinking Water Solution ................... 006–677 ...... 006–707 ...... S.Q. (sulfaquinoxaline) 20% Solution .......................................... SULQUIN 6–50 (Sulfaquinoxaline) .............................................. 006–891 007–087 008–622 011–315 015–160 031–205 031–553 032–946 SUL–Q–NOX (sulfaquinoxaline) Solution .................................... Sulfaquinoxaline Solubilized (Powder) ........................................ TERRAMYCIN (oxytetracycline) Soluble Powder ....................... NEOMIX 325 (neomycin) Soluble Powder .................................. Sodium Sulfachloropyrazine Solution .......................................... AGRIBON (sulfadimethoxine) 12.5% Drinking Water Solution ... ESB 3 (sulfachloropyrazine) Soluble Powder/Solution ............... MAGNA TERRAMYCIN (oxytetracycline and carbomycin) Soluble Powder. VETSULID SP (sulfachloropyridazine) Soluble Powder ............. GALLIMYCIN (erythromycin) Soluble Powder ............................ Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str., 1113 Sophia, Bulgaria (Huvepharma EOOD). Huvepharma EOOD. Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007 (Zoetis Inc.). Huvepharma EOOD. Huvepharma EOOD. Zoetis Inc. Zoetis Inc. Zoetis Inc. Zoetis Inc. Zoetis Inc. Zoetis Inc. 033–373 ...... 035–157 ...... 038–200 ...... MEDAMYCIN (oxytetracycline) Soluble Powder ......................... 038–661 046–109 046–285 055–012 ...... ...... ...... ...... 055–020 055–060 065–071 065–123 065–140 065–178 065–256 asabaliauskas on DSK3SPTVN1PROD with RULES File No. ...... ...... ...... ...... ...... ...... ...... SPECTOGARD (spectinomycin) Water Soluble Powder ............ L–S 50 (lincomycin and spectinomycin) Water Soluble Powder AGRIBON (sulfadimethoxine) Soluble Powder ........................... CHLORONEX SULMET (chlortetracycline bisulfate and sulfamethazine) Soluble Powder. AUREOMYCIN (chlortetracycline) Soluble Powder .................... Penicillin G Potassium, USP ....................................................... AUREOMYCIN (chlortetracycline) Soluble Powder .................... Tetracycline Soluble Powder ....................................................... TET–SOL 324 (tetracycline) Soluble Powder ............................. FERMYCIN (chlortetracycline) Soluble ....................................... CHLORO–SOLUBLE–O (chlortetracycline) Soluble Powder ...... 065–269 065–410 065–440 065–441 065–480 065–486 ...... ...... ...... ...... ...... ...... POLYOTIC (tetracycline) Soluble Powder .................................. TETRA–SAL (tetracycline) Soluble Powder ................................ CHLORONEX (chlortetracycline) Soluble Powder ...................... POLYOTIC (tetracycline) Soluble Powder Concentrate .............. Chlortetracycline Soluble Powder ................................................ Chlortetracycline Bisulfate Soluble Powder ................................. 065–496 ...... 091–191 ...... Tetracycline Soluble Powder ....................................................... GENTOCIN (gentamicin) Oral Solution ....................................... 100–094 ...... POULTRY SULFA (sulfamerazine, sulfamethazine, and sulfaquinoxaline) Soluble Powder. APRALAN (apramycin) Soluble Powder ..................................... LINCOMIX (lincomycin) Soluble Powder ..................................... ...... ...... ...... ...... ...... ...... ...... ...... 106–964 ...... 111–636 ...... VerDate Sep<11>2014 19:06 Dec 23, 2016 Jkt 241001 PO 00000 Frm 00079 Fmt 4700 Huvepharma EOOD. Cross Vetpharm Group Ltd., Broomhill Rd., Tallaght, Dublin 24, Ireland (Cross Vetpharm Group Ltd.). Phibro Animal Health Corp., GlenPointe Centre East, 3d floor, 300 Frank W. Burr Blvd., suite 21, Teaneck, NJ 07666 (Phibro Animal Health Corp.). Cross Vetpharm Group Ltd. Zoetis Inc. Zoetis Inc. Huvepharma EOOD. Zoetis Inc. Zoetis Inc. Huvepharma EOOD. Zoetis Inc. Huvepharma EOOD. Phibro Animal Health Corp. Pharmgate LLC, 1015 Ashes Dr., suite 102, Wilmington, NC 28405 (Pharmgate LLC). Huvepharma EOOD. Zoetis Inc. Huvepharma EOOD. Zoetis Inc. Pharmgate LLC. Strategic Veterinary Pharmaceuticals, Inc., 100 NW. Airport Rd., St. Joseph, MO 64503 (Strategic Vet. Pharm., Inc.). Phibro Animal Health Corp. Intervet, Inc., 2 Giralda Farms, Madison, NJ 07940 (Intervet, Inc.). Huvepharma EOOD. Elanco US Inc. Zoetis Inc. Sfmt 4700 E:\FR\FM\27DER1.SGM 27DER1 94988 Federal Register / Vol. 81, No. 248 / Tuesday, December 27, 2016 / Rules and Regulations File No. Animal drug product Sponsor Huvepharma EOOD. Huvepharma EOOD. Intervet, Inc. Zoetis Inc. Pharmgate LLC. Agri Laboratories, Ltd., P.O. Box 3103, St. Joseph, MO 64503 (Agri Laboratories, Ltd.). Agri Laboratories, Ltd. Zoetis Inc. Agri Laboratories, Ltd. Cross Vetpharm Group Ltd. Agri Laboratories, Ltd. Cross Vetpharm Group Ltd. Huvepharma EOOD. Zoetis Inc. Huvepharma EOOD. Zoetis Inc. Zoetis Inc. Quo Vademus, LLC, 277 Faison McGowan Rd., Kenansville, NC 28349 (Quo Vademus, LLC). Cross Vetpharm Group Ltd. Cross Vetpharm Group Ltd. Huvepharma EOOD. Strategic Vet. Pharm., Inc. Agri Laboratories, Ltd. Huvepharma EOOD. Med-Pharmex, Inc., 2727 Thompson Creek Rd., Pomona, CA 91767–1861 (Med-Pharmex, Inc.). Huvepharma EOOD. Huvepharma EOOD. Zoetis Inc. Med-Pharmex, Inc. Med-Pharmex, Inc. Quo Vademus, LLC. Med-Pharmex, Inc. Med-Pharmex, Inc. Cross Vetpharm Group Ltd. Med-Pharmex, Inc. Phibro Animal Health Corp. Med-Pharmex, Inc. Pharmgate LLC. Quo Vademus, LLC. Phibro Animal Health Corp. Quo Vademus, LLC. G.C. Hanford Manufacturing Co., P.O. Box 1017, Syracuse, NY 13201 (G.C. Hanford Mfg. Co.). Cross Vetpharm Group Ltd. Cross Vetpharm Group Ltd. Cross Vetpharm Group Ltd. Sparhawk Laboratories, Inc., 12340 Santa Fe Trail Dr., Lenexa, KS 66215 (Sparhawk Laboratories, Inc.). Sparhawk Laboratories, Inc. Cross Vetpharm Group Ltd. Agri Laboratories, Ltd. Cross Vetpharm Group Ltd. Huvepharma EOOD. First Priority, Inc., 1590 Todd Farm Dr., Elgin, IL 60123. Cross Vetpharm Group Ltd. Cross Vetpharm Group Ltd. ...... ...... ...... ...... ...... ...... SULMET (sulfamethazine) Soluble Powder ................................ OXY–TET (oxytetracycline) Soluble Powder ............................... GARACIN (gentamicin) Soluble Powder ..................................... SOLU–TET 324 (tetracycline) Soluble Powder ........................... PENNOX 343 (oxytetracycline) ................................................... Sulfadimethoxine 12.5% Oral Solution ........................................ 200–031 200–046 200–049 200–050 200–066 200–103 200–106 200–113 200–118 200–122 200–130 200–136 ...... ...... ...... ...... ...... ...... ...... ...... ...... ...... ...... ...... Sulfadimethoxine Antibacterial Soluble Powder .......................... Neomycin Soluble Powder .......................................................... Tetracycline Hydrochloride Soluble Powder-324 ........................ NEOMED (neomycin) Soluble Powder ........................................ AGRIMYCIN–343 (oxytetracycline) Soluble Powder ................... PENAQUA SOL–G (penicillin G potassium) Soluble Powder ..... R–PEN (penicillin G potassium) Soluble Powder ....................... BIOSOL® (neomycin) Liquid ........................................................ Neomycin Oral Solution ............................................................... SOLU–PEN (penicillin G potassium) Soluble Powder ................ NEO–SOL 50 (neomycin) Soluble Powder ................................. Tetracycline Hydrochloride Soluble Powder-324 ........................ 200–144 200–146 200–153 200–165 200–185 200–189 200–190 ...... ...... ...... ...... ...... ...... ...... Oxytetracycline HCl Soluble Powder ........................................... TETROXY 25 (oxytetracycline) ................................................... NEO 200 (neomycin) Oral Solution ............................................. SDM (sulfadimethoxine) 12.5% Oral Solution ............................. GEN–GARD (Gentamicin sulfate) Soluble Powder ..................... Lincomycin Soluble ...................................................................... GENTORAL (gentamicin sulfate) Oral Solution .......................... 200–192 200–197 200–233 200–234 200–235 200–236 200–238 200–241 200–247 200–251 200–258 200–289 200–295 200–303 200–345 200–347 200–372 ...... ...... ...... ...... ...... ...... ...... ...... ...... ...... ...... ...... ...... ...... ...... ...... ...... Sulfadimethoxine 12.5% Oral Solution ........................................ Streptomycin Oral Solution w/STREP SOL (RLNAD 065–252) .. LINCO (lincomycin) Soluble Powder ........................................... TETRASOL (tetracycline) Soluble Powder .................................. NEOSOL (neomycin) Soluble Powder ........................................ Chlortetracycline HCL Soluble Powder ....................................... SULFASOL (sulfadimethoxine) Soluble Powder ......................... LINCOSOL (lincomycin) Soluble Powder .................................... TETROXY 343 (oxytetracycline) Soluble Powder ....................... SULFORAL (Sulfadimethoxine) Soluble Powder ........................ Sulfadimethoxine Soluble Powder ............................................... NEOSOL–ORAL (neomycin) Soluble Powder ............................. PENNCHLOR 64 (chlortetracycline) Soluble Powder ................. Lincomycin Hydrochloride Soluble Powder ................................. Lincomycin-Spectinomycin Soluble Powder ................................ Penicillin G Potassium USP ........................................................ HAN–PEN (penicillin G potassium) Soluble Powder .................. 200–374 200–376 200–377 200–378 ...... ...... ...... ...... TETRAMED 324 HCA (tetracycline) Soluble Powder ................. SULFAMED–G (sulfadimethoxine) Soluble Powder ................... LINXMED–SP (lincomycin and spectinomycin) Soluble Powder Neomycin Sulfate 325 Soluble Powder ....................................... 200–379 200–380 200–407 200–434 200–441 200–443 200–460 200–494 asabaliauskas on DSK3SPTVN1PROD with RULES 122–272 130–435 133–836 140–578 200–026 200–030 ...... ...... ...... ...... ...... ...... ...... ...... Neomycin Liquid .......................................................................... SPECLINX–50 (lincomycin and spectinomycin) Soluble Powder Lincomycin-Spectinomycin Water Soluble Powder ..................... SMZ–MED 454 (sulfamethazine) Soluble Powder ...................... AUREOMYCIN (chlortetracycline) Soluble Powder .................... Sulfadimethoxine Soluble Powder ............................................... TETROXY AQUATIC (oxytetracycline) Soluble Powder ............. GENTAMED (gentamicin) Soluble Powder ................................. The animal drug regulations are also being amended to reflect several nonsubstantive 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 VerDate Sep<11>2014 19:06 Dec 23, 2016 Jkt 241001 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. PO 00000 Frm 00080 Fmt 4700 Sfmt 4700 List of Subjects in 21 CFR Parts 520 and 529 Animal drugs. 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: E:\FR\FM\27DER1.SGM 27DER1 Federal Register / Vol. 81, No. 248 / Tuesday, December 27, 2016 / Rules and Regulations Withdraw 1 day before slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian. ■ 6. In § 520.1044a, revise paragraph (d)(3) to read as follows: PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS 1. The authority citation for part 520 continues to read as follows: ■ Authority: 21 U.S.C. 360b. § 520.110 [Amended] 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.’’ ■ § 520.441 [Amended] 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.’’ ■ § 520.445 [Amended] 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.’’ ■ 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: ■ § 520.823 Erythromycin. asabaliauskas on DSK3SPTVN1PROD with RULES * * * * * (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. VerDate Sep<11>2014 19:06 Dec 23, 2016 Jkt 241001 § 520.1044a solution. Gentamicin sulfate oral * * * * * (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. ■ 7. In § 520.1044c, remove paragraph (d)(4) and revise paragraph (d)(3) to read as follows: § 520.1044c 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. § 520.1263c [Amended] 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.’’ ■ 9. In § 520.1265, add paragraph (d)(3) to read as follows: ■ § 520.1265 powder. Lincomycin and spectinomycin * * * * * (d) * * * (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. ■ 10. In § 520.1484, revise paragraphs (e)(1)(iii) and (e)(2)(iii) to read as follows: § 520.1484 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. PO 00000 Frm 00081 Fmt 4700 Sfmt 4700 94989 11. In § 520.1660a, revise the section heading and paragraphs (e)(1) and (e)(3) to read as follows: ■ § 520.1660a 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. ■ 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: § 520.1660d * 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 E:\FR\FM\27DER1.SGM 27DER1 asabaliauskas on DSK3SPTVN1PROD with RULES 94990 Federal Register / Vol. 81, No. 248 / Tuesday, December 27, 2016 / Rules and Regulations 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. (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 VerDate Sep<11>2014 19:06 Dec 23, 2016 Jkt 241001 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. ■ 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: § 520.1696b 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. § 520.2123b [Amended] 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.’’ ■ § 520.2184 [Amended] 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.’’ ■ § 520.2200 [Amended] 16. In § 520.2200, in paragraphs (d)(1)(iii) and (d)(2)(iii), as the last ■ PO 00000 Frm 00082 Fmt 4700 Sfmt 4700 sentence add ‘‘Federal law restricts this drug to use by or on the order of a licensed veterinarian.’’ § 520.2218 [Amended] 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.’’ ■ 18. In § 520.2220a, revise the section heading and paragraphs (d)(1)(iii), (d)(2)(iii), and (d)(3)(iii) to read as follows: ■ § 520.2220a 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. § 520.2261a [Amended] 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.’’ ■ § 520.2261b [Amended] 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.’’ ■ § 520.2325a [Amended] 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.’’ ■ § 520.2345d [Amended] 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.’’ ■ E:\FR\FM\27DER1.SGM 27DER1 Federal Register / Vol. 81, No. 248 / Tuesday, December 27, 2016 / Rules and Regulations Final rule; technical amendment. animal drug applications (ANADAs) for revised labeling reflecting a change in marketing status from over-the-counter (OTC) use to use by veterinary feed directive (VFD) for antimicrobial drugs of importance to human medicine administered to food-producing animals in medicated feed. Where applicable, FDA is also withdrawing approval of those parts of the NADAs that pertain to use of these antimicrobial drugs for growth promotion indications. These actions are being taken at the sponsors’ requests because these particular medicated feeds will no longer be manufactured or marketed. These applications were submitted in voluntary compliance with the goals of FDA Center for Veterinary Medicine’s (CVM’s) Judicious Use Initiative. In addition, the animal drug regulations are being amended to reflect the voluntary withdrawal of approval of certain entire NADAs and ANADAs that were affected by this initiative. The animal drug regulations are also being amended to reflect several nonsubstantive changes in format. These technical amendments are being made to improve the consistency and readability of the regulations. DATES: This rule is effective December 30, 2016. 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. SUPPLEMENTARY INFORMATION: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of 71 supplemental new animal drug applications (NADAs) and 35 supplemental abbreviated new I. Supplemental Approval of Revised Labeling and Withdrawal of Approval of Portions of NADAs Pertaining to Production Indications FDA is amending the animal drug regulations to reflect approval of 71 PART 529—CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS 23. The authority citation for part 529 continues to read as follows: ■ Authority: 21 U.S.C. 360b. 24. In § 529.1660, add paragraph (d)(3) to read as follows: ■ § 529.1660 Oxytetracycline. * * * * * (d) * * * (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Dated: December 20, 2016. Tracey H. Forfa, Deputy Director, Center for Veterinary Medicine. [FR Doc. 2016–31084 Filed 12–23–16; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 556 and 558 [Docket No. FDA–2016–N–0002] New Animal Drugs for Use in Animal Feed; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications AGENCY: Food and Drug Administration, HHS. ACTION: SUMMARY: 94991 supplemental NADAs and 35 supplemental ANADAs for revised labeling reflecting a change in marketing status from OTC use to use by VFD for antimicrobial drugs of importance to human medicine administered to foodproducing animals in medicated feed. Where applicable, FDA is also withdrawing approval of those parts of the NADAs that pertain to use of these antimicrobial drugs for growth promotion indications. These actions are being taken at the sponsors’ requests because these particular medicated feeds will no longer be manufactured or marketed. 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 (https://www.fda.gov/downloads/ AnimalVeterinary/ GuidanceComplianceEnforcement/ GuidanceforIndustry/UCM299624.pdf). Their change to VFD marketing status is consistent with FDA CVM’s initiative for the Judicious Use of Antimicrobials. The animal drug regulations for medicated feeds 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. The affected applications for Type A medicated articles for which supplemental applications with revised labeling were approved follow: Animal drug product Sponsor 006–391 ........ S.Q. 40% (sulfaquinoxaline) Type A Medicated Article ............. 008–804 ........ TM–50 or TM–100 (oxytetracycline) Type A Medicated Article 010–092 ........ GALLIMYCIN–100P (erythromycin) Type A Medicated Article .. 010–918 ........ HYGROMIX 8 (hygromycin B) Type A Medicated Article .......... 012–491 ........ 033–950 ........ asabaliauskas on DSK3SPTVN1PROD with RULES File No. TYLAN (tylosin) Type A Medicated Article ................................. Sulfamerazine In Fish Grade ...................................................... 035–688 ........ AUREOMIX S 40/40 (chlortetracycline and sulfamethazine) Granular Type A Medicated Article. AUREO S 700 (chlortetracycline and sulfamethazine) Granular Type A Medicated Article. TERRAMYCIN 200 (oxytetracycline) for Fish Type A Medicated Article. ROFENAID 40 (sulfadimethoxine and ormetoprim) Type A Medicated Article. Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str., 1113 Sophia, Bulgaria (Huvepharma EOOD). Phibro Animal Health Corp., GlenPointe Centre East, 3d Floor, 300 Frank W. Burr Blvd., Suite 21, Teaneck, NJ 07666 (Phibro Animal Health Corp.). Cross Vetpharm Group Ltd., Broomhill Rd., Tallaght, Dublin 24, Ireland (Cross Vetpharm Group Ltd.). Elanco US Inc., 2500 Innovation Way, Greenfield, IN 46140 (Elanco US Inc.). Elanco US Inc. Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007 (Zoetis Inc.). Zoetis Inc. 035–805 ........ 038–439 ........ 040–209 ........ VerDate Sep<11>2014 19:06 Dec 23, 2016 Jkt 241001 PO 00000 Frm 00083 Fmt 4700 Zoetis Inc. Phibro Animal Health Corp. Zoetis Inc. Sfmt 4700 E:\FR\FM\27DER1.SGM 27DER1

Agencies

[Federal Register Volume 81, Number 248 (Tuesday, December 27, 2016)]
[Rules and Regulations]
[Pages 94987-94991]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-31084]



[[Page 94987]]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 520 and 529

[Docket No. FDA-2016-N-0002]


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

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.

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.

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 (https://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 product         Sponsor
------------------------------------------------------------------------
006-084.....................  SULMET                Huvepharma EOOD, 5th
                               (sulfamethazine)      Floor, 3A Nikolay
                               Drinking Water        Haytov Str., 1113
                               Solution.             Sophia, Bulgaria
                                                     (Huvepharma EOOD).
006-677.....................  S.Q.                  Huvepharma EOOD.
                               (sulfaquinoxaline)
                               20% Solution.
006-707.....................  SULQUIN 6-50          Zoetis Inc., 333
                               (Sulfaquinoxaline).   Portage St.,
                                                     Kalamazoo, MI 49007
                                                     (Zoetis Inc.).
006-891.....................  SUL-Q-NOX             Huvepharma EOOD.
                               (sulfaquinoxaline)
                               Solution.
007-087.....................  Sulfaquinoxaline      Huvepharma EOOD.
                               Solubilized
                               (Powder).
008-622.....................  TERRAMYCIN            Zoetis Inc.
                               (oxytetracycline)
                               Soluble Powder.
011-315.....................  NEOMIX 325            Zoetis Inc.
                               (neomycin) Soluble
                               Powder.
015-160.....................  Sodium                Zoetis Inc.
                               Sulfachloropyrazine
                               Solution.
031-205.....................  AGRIBON               Zoetis Inc.
                               (sulfadimethoxine)
                               12.5% Drinking
                               Water Solution.
031-553.....................  ESB 3                 Zoetis Inc.
                               (sulfachloropyrazin
                               e) Soluble Powder/
                               Solution.
032-946.....................  MAGNA TERRAMYCIN      Zoetis Inc.
                               (oxytetracycline
                               and carbomycin)
                               Soluble Powder.
033-373.....................  VETSULID SP           Huvepharma EOOD.
                               (sulfachloropyridaz
                               ine) Soluble Powder.
035-157.....................  GALLIMYCIN            Cross Vetpharm Group
                               (erythromycin)        Ltd., Broomhill
                               Soluble Powder.       Rd., Tallaght,
                                                     Dublin 24, Ireland
                                                     (Cross Vetpharm
                                                     Group Ltd.).
038-200.....................  MEDAMYCIN             Phibro Animal Health
                               (oxytetracycline)     Corp., GlenPointe
                               Soluble Powder.       Centre East, 3d
                                                     floor, 300 Frank W.
                                                     Burr Blvd., suite
                                                     21, Teaneck, NJ
                                                     07666 (Phibro
                                                     Animal Health
                                                     Corp.).
038-661.....................  SPECTOGARD            Cross Vetpharm Group
                               (spectinomycin)       Ltd.
                               Water Soluble
                               Powder.
046-109.....................  L-S 50 (lincomycin    Zoetis Inc.
                               and spectinomycin)
                               Water Soluble
                               Powder.
046-285.....................  AGRIBON               Zoetis Inc.
                               (sulfadimethoxine)
                               Soluble Powder.
055-012.....................  CHLORONEX SULMET      Huvepharma EOOD.
                               (chlortetracycline
                               bisulfate and
                               sulfamethazine)
                               Soluble Powder.
055-020.....................  AUREOMYCIN            Zoetis Inc.
                               (chlortetracycline)
                               Soluble Powder.
055-060.....................  Penicillin G          Zoetis Inc.
                               Potassium, USP.
065-071.....................  AUREOMYCIN            Huvepharma EOOD.
                               (chlortetracycline)
                               Soluble Powder.
065-123.....................  Tetracycline Soluble  Zoetis Inc.
                               Powder.
065-140.....................  TET-SOL 324           Huvepharma EOOD.
                               (tetracycline)
                               Soluble Powder.
065-178.....................  FERMYCIN              Phibro Animal Health
                               (chlortetracycline)   Corp.
                               Soluble.
065-256.....................  CHLORO-SOLUBLE-O      Pharmgate LLC, 1015
                               (chlortetracycline)   Ashes Dr., suite
                               Soluble Powder.       102, Wilmington, NC
                                                     28405 (Pharmgate
                                                     LLC).
065-269.....................  POLYOTIC              Huvepharma EOOD.
                               (tetracycline)
                               Soluble Powder.
065-410.....................  TETRA-SAL             Zoetis Inc.
                               (tetracycline)
                               Soluble Powder.
065-440.....................  CHLORONEX             Huvepharma EOOD.
                               (chlortetracycline)
                               Soluble Powder.
065-441.....................  POLYOTIC              Zoetis Inc.
                               (tetracycline)
                               Soluble Powder
                               Concentrate.
065-480.....................  Chlortetracycline     Pharmgate LLC.
                               Soluble Powder.
065-486.....................  Chlortetracycline     Strategic Veterinary
                               Bisulfate Soluble     Pharmaceuticals,
                               Powder.               Inc., 100 NW.
                                                     Airport Rd., St.
                                                     Joseph, MO 64503
                                                     (Strategic Vet.
                                                     Pharm., Inc.).
065-496.....................  Tetracycline Soluble  Phibro Animal Health
                               Powder.               Corp.
091-191.....................  GENTOCIN              Intervet, Inc., 2
                               (gentamicin) Oral     Giralda Farms,
                               Solution.             Madison, NJ 07940
                                                     (Intervet, Inc.).
100-094.....................  POULTRY SULFA         Huvepharma EOOD.
                               (sulfamerazine,
                               sulfamethazine, and
                               sulfaquinoxaline)
                               Soluble Powder.
106-964.....................  APRALAN (apramycin)   Elanco US Inc.
                               Soluble Powder.
111-636.....................  LINCOMIX              Zoetis Inc.
                               (lincomycin)
                               Soluble Powder.

[[Page 94988]]

 
122-272.....................  SULMET                Huvepharma EOOD.
                               (sulfamethazine)
                               Soluble Powder.
130-435.....................  OXY-TET               Huvepharma EOOD.
                               (oxytetracycline)
                               Soluble Powder.
133-836.....................  GARACIN (gentamicin)  Intervet, Inc.
                               Soluble Powder.
140-578.....................  SOLU-TET 324          Zoetis Inc.
                               (tetracycline)
                               Soluble Powder.
200-026.....................  PENNOX 343            Pharmgate LLC.
                               (oxytetracycline).
200-030.....................  Sulfadimethoxine      Agri Laboratories,
                               12.5% Oral Solution.  Ltd., P.O. Box
                                                     3103, St. Joseph,
                                                     MO 64503 (Agri
                                                     Laboratories,
                                                     Ltd.).
200-031.....................  Sulfadimethoxine      Agri Laboratories,
                               Antibacterial         Ltd.
                               Soluble Powder.
200-046.....................  Neomycin Soluble      Zoetis Inc.
                               Powder.
200-049.....................  Tetracycline          Agri Laboratories,
                               Hydrochloride         Ltd.
                               Soluble Powder-324.
200-050.....................  NEOMED (neomycin)     Cross Vetpharm Group
                               Soluble Powder.       Ltd.
200-066.....................  AGRIMYCIN-343         Agri Laboratories,
                               (oxytetracycline)     Ltd.
                               Soluble Powder.
200-103.....................  PENAQUA SOL-G         Cross Vetpharm Group
                               (penicillin G         Ltd.
                               potassium) Soluble
                               Powder.
200-106.....................  R-PEN (penicillin G   Huvepharma EOOD.
                               potassium) Soluble
                               Powder.
200-113.....................  BIOSOL[supreg]        Zoetis Inc.
                               (neomycin) Liquid.
200-118.....................  Neomycin Oral         Huvepharma EOOD.
                               Solution.
200-122.....................  SOLU-PEN (penicillin  Zoetis Inc.
                               G potassium)
                               Soluble Powder.
200-130.....................  NEO-SOL 50            Zoetis Inc.
                               (neomycin) Soluble
                               Powder.
200-136.....................  Tetracycline          Quo Vademus, LLC,
                               Hydrochloride         277 Faison McGowan
                               Soluble Powder-324.   Rd., Kenansville,
                                                     NC 28349 (Quo
                                                     Vademus, LLC).
200-144.....................  Oxytetracycline HCl   Cross Vetpharm Group
                               Soluble Powder.       Ltd.
200-146.....................  TETROXY 25            Cross Vetpharm Group
                               (oxytetracycline).    Ltd.
200-153.....................  NEO 200 (neomycin)    Huvepharma EOOD.
                               Oral Solution.
200-165.....................  SDM                   Strategic Vet.
                               (sulfadimethoxine)    Pharm., Inc.
                               12.5% Oral Solution.
200-185.....................  GEN-GARD (Gentamicin  Agri Laboratories,
                               sulfate) Soluble      Ltd.
                               Powder.
200-189.....................  Lincomycin Soluble..  Huvepharma EOOD.
200-190.....................  GENTORAL (gentamicin  Med-Pharmex, Inc.,
                               sulfate) Oral         2727 Thompson Creek
                               Solution.             Rd., Pomona, CA
                                                     91767-1861 (Med-
                                                     Pharmex, Inc.).
200-192.....................  Sulfadimethoxine      Huvepharma EOOD.
                               12.5% Oral Solution.
200-197.....................  Streptomycin Oral     Huvepharma EOOD.
                               Solution w/STREP
                               SOL (RLNAD 065-252).
200-233.....................  LINCO (lincomycin)    Zoetis Inc.
                               Soluble Powder.
200-234.....................  TETRASOL              Med-Pharmex, Inc.
                               (tetracycline)
                               Soluble Powder.
200-235.....................  NEOSOL (neomycin)     Med-Pharmex, Inc.
                               Soluble Powder.
200-236.....................  Chlortetracycline     Quo Vademus, LLC.
                               HCL Soluble Powder.
200-238.....................  SULFASOL              Med-Pharmex, Inc.
                               (sulfadimethoxine)
                               Soluble Powder.
200-241.....................  LINCOSOL              Med-Pharmex, Inc.
                               (lincomycin)
                               Soluble Powder.
200-247.....................  TETROXY 343           Cross Vetpharm Group
                               (oxytetracycline)     Ltd.
                               Soluble Powder.
200-251.....................  SULFORAL              Med-Pharmex, Inc.
                               (Sulfadimethoxine)
                               Soluble Powder.
200-258.....................  Sulfadimethoxine      Phibro Animal Health
                               Soluble Powder.       Corp.
200-289.....................  NEOSOL-ORAL           Med-Pharmex, Inc.
                               (neomycin) Soluble
                               Powder.
200-295.....................  PENNCHLOR 64          Pharmgate LLC.
                               (chlortetracycline)
                               Soluble Powder.
200-303.....................  Lincomycin            Quo Vademus, LLC.
                               Hydrochloride
                               Soluble Powder.
200-345.....................  Lincomycin-           Phibro Animal Health
                               Spectinomycin         Corp.
                               Soluble Powder.
200-347.....................  Penicillin G          Quo Vademus, LLC.
                               Potassium USP.
200-372.....................  HAN-PEN (penicillin   G.C. Hanford
                               G potassium)          Manufacturing Co.,
                               Soluble Powder.       P.O. Box 1017,
                                                     Syracuse, NY 13201
                                                     (G.C. Hanford Mfg.
                                                     Co.).
200-374.....................  TETRAMED 324 HCA      Cross Vetpharm Group
                               (tetracycline)        Ltd.
                               Soluble Powder.
200-376.....................  SULFAMED-G            Cross Vetpharm Group
                               (sulfadimethoxine)    Ltd.
                               Soluble Powder.
200-377.....................  LINXMED-SP            Cross Vetpharm Group
                               (lincomycin and       Ltd.
                               spectinomycin)
                               Soluble Powder.
200-378.....................  Neomycin Sulfate 325  Sparhawk
                               Soluble Powder.       Laboratories, Inc.,
                                                     12340 Santa Fe
                                                     Trail Dr., Lenexa,
                                                     KS 66215 (Sparhawk
                                                     Laboratories,
                                                     Inc.).
200-379.....................  Neomycin Liquid.....  Sparhawk
                                                     Laboratories, Inc.
200-380.....................  SPECLINX-50           Cross Vetpharm Group
                               (lincomycin and       Ltd.
                               spectinomycin)
                               Soluble Powder.
200-407.....................  Lincomycin-           Agri Laboratories,
                               Spectinomycin Water   Ltd.
                               Soluble Powder.
200-434.....................  SMZ-MED 454           Cross Vetpharm Group
                               (sulfamethazine)      Ltd.
                               Soluble Powder.
200-441.....................  AUREOMYCIN            Huvepharma EOOD.
                               (chlortetracycline)
                               Soluble Powder.
200-443.....................  Sulfadimethoxine      First Priority,
                               Soluble Powder.       Inc., 1590 Todd
                                                     Farm Dr., Elgin, IL
                                                     60123.
200-460.....................  TETROXY AQUATIC       Cross Vetpharm Group
                               (oxytetracycline)     Ltd.
                               Soluble Powder.
200-494.....................  GENTAMED              Cross Vetpharm Group
                               (gentamicin)          Ltd.
                               Soluble Powder.
------------------------------------------------------------------------

    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.

List of Subjects in 21 CFR Parts 520 and 529

    Animal drugs.

    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:

[[Page 94989]]

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

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

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


Sec.  520.110  [Amended]

0
2. In Sec.  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.''


Sec.  520.441  [Amended]

0
3. In Sec.  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.''


Sec.  520.445  [Amended]

0
4. In Sec.  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.''

0
5. In Sec.  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:


Sec.  520.823  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.

0
6. In Sec.  520.1044a, revise paragraph (d)(3) to read as follows:


Sec.  520.1044a  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.

0
7. In Sec.  520.1044c, remove paragraph (d)(4) and revise paragraph 
(d)(3) to read as follows:


Sec.  520.1044c  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.


Sec.  520.1263c  [Amended]

0
8. In Sec.  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.''

0
9. In Sec.  520.1265, add paragraph (d)(3) to read as follows:


Sec.  520.1265  Lincomycin and spectinomycin powder.

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

0
10. In Sec.  520.1484, revise paragraphs (e)(1)(iii) and (e)(2)(iii) to 
read as follows:


Sec.  520.1484  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.

0
11. In Sec.  520.1660a, revise the section heading and paragraphs 
(e)(1) and (e)(3) to read as follows:


Sec.  520.1660a  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.

0
12. In Sec.  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:


Sec.  520.1660d  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 Sec.  510.600(c) of this chapter. Withdraw 4 days 
prior to slaughter

[[Page 94990]]

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.
    (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 Sec.  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 Sec.  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 Sec.  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.

0
13. In Sec.  520.1696b, redesignate paragraph (c) as paragraph (d) and 
add new paragraph (c), and revise redesignated paragraph (d)(3) to read 
as follows:


Sec.  520.1696b  Penicillin G powder.

* * * * *
    (c) Related tolerances. See Sec.  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.


Sec.  520.2123b  [Amended]

0
14. In Sec.  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.''


Sec.  520.2184  [Amended]

0
15. In Sec.  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.''


Sec.  520.2200  [Amended]

0
16. In Sec.  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.''


Sec.  520.2218   [Amended]

0
17. In Sec.  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.''

0
18. In Sec.  520.2220a, revise the section heading and paragraphs 
(d)(1)(iii), (d)(2)(iii), and (d)(3)(iii) to read as follows:


Sec.  520.2220a  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.


Sec.  520.2261a  [Amended]

0
19. In Sec.  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.''


Sec.  520.2261b  [Amended]

0
20. In Sec.  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.''


Sec.  520.2325a  [Amended]

0
21. In Sec.  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.''


Sec.  520.2345d   [Amended]

0
22. In Sec.  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.''

[[Page 94991]]

PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

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

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

0
24. In Sec.  529.1660, add paragraph (d)(3) to read as follows:


Sec.  529.1660   Oxytetracycline.

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

    Dated: December 20, 2016.
Tracey H. Forfa,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. 2016-31084 Filed 12-23-16; 8:45 am]
 BILLING CODE 4164-01-P
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