New Animal Drugs for Use in Animal Feed; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications, 94991-95025 [2016-31083]

Download as PDF 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 94992 Federal Register / Vol. 81, No. 248 / Tuesday, December 27, 2016 / Rules and Regulations File No. Animal drug product 041–275 ........ TYLAN 40 Sulfa-G (tylosin and sulfamethazine) Type A Medicated Article. AUREOMIX S 700–A (chlortetracycline and sulfamethazine) Type A Medicated Article. AUREOMIX S 700–D (chlortetracycline and sulfamethazine) Type A Medicated Article. AUREOMIX S 700–G (chlortetracycline and sulfamethazine) Type A Medicated Article. AUREOMIX S 700–E (chlortetracycline and sulfamethazine) Type A Medicated Article. AUREOMIX S 700–F (chlortetracycline and sulfamethazine) Type A Medicated Article. AUREOMIX S 700–C–2 (chlortetracycline and sulfamethazine) Type A Medicated Article. AUREOMIX S 700–B (chlortetracycline and sulfamethazine) Type A Medicated Article. AUREOMIX S 700–H (chlortetracycline and sulfamethazine) Type A Medicated Article. Tylosin Type A Medicated Article ............................................... CHLORMAX (chlortetracycline) Type A Medicated Article ........ CHLORATET (chlortetracycline) Type A Medicated Article ....... 041–647 ........ 041–648 ........ 041–649 ........ 041–650 ........ 041–651 ........ 041–652 ........ 041–653 ........ 041–654 ........ 046–415 ........ 046–699 ........ 048–480 ........ 048–761 ........ 049–287 ........ 091–749 ........ 092–286 ........ 092–287 ........ 094–975 ........ 095–143 ........ 097–505 ........ 098–431 ........ 100–901 ........ 125–933 ........ 126–050 ........ 138–934 ........ 138–935 ........ 138–938 ........ 138–939 ........ 140–976 ........ 200–314 ........ 200–484 ........ 200–510 ........ Sponsor AUREOMYCIN (chlortetracycline) Type A Medicated Article .... CHLORACHEL (chlortetracycline)Type A Medicated Article ..... TYLAN 40 Plus Sulfa-G (tylosin and sulfamethazine) Type A Medicated Article. CLTC–50 MR (chlortetracycline) Type A Medicated Article ....... CLTC 100 MR (chlortetracycline) Type A Medicated Article ..... NEO-TERRAMYCIN 100/100 (oxytetracycline and neomycin) Type A Medicated Article. TERRAMYCIN 10, 30, 50, 100, or 200 (oxytetracycline) Type A Medicated Article. LINCOMIX 20 (lincomycin) Type A Medicated Article ............... TYLAN 10 (tylosin) Premix Type A Medicated Article ............... PFICHLOR 100S (chlortetracycline) Milk Replacer Type A Medicated Article. ROMET–30 (ormetoprim and sulfadimethoxine) Type A Medicated Article. APRALAN 75 (apramycin) Type A Medicated Article ................ PENNCHLOR S 40/40 (chlortetracycline and sulfamethazine) Type A medicated article. PENNCHLOR 100 MR (chlortetracycline) Type A Medicated Article. PENNOX 50, 100, or 200 Hi-Flo, or 100–MR (oxytetracycline) Type A Medicated Article. NEO-OXY 100/100 MR (oxytetracycline and neomycin) Type A Medicated Article. NEOMIX 325 Milk Replacer (neomycin) Type A Medicated Article. PENNCHLOR S (chlortetracycline and sulfamethazine) Type A Medicated Article. TYLOVET 100 (tylosin) Type A Medicated Article ..................... DERACIN 100 (chlortetracycline) Type A Medicated Article ..... Elanco US Inc. Zoetis Inc. Zoetis Inc. Zoetis Inc. Zoetis Inc. Zoetis Inc. Zoetis Inc. Zoetis Inc. Zoetis Inc. Zoetis Inc. Zoetis Inc. Pharmgate LLC, 1015 Ashes Dr., Suite 102, Wilmington, NC 28405 (Pharmgate LLC). Zoetis Inc. Zoetis Inc. Zoetis Inc. Phibro Animal Health Corp. Phibro Animal Health Corp. Phibro Animal Health Corp. Phibro Animal Health Corp. Zoetis Inc. Phibro Animal Health Corp. Zoetis Inc. Pharmaq AS. Elanco US Inc. Pharmgate LLC. Pharmgate LLC. Pharmgate LLC. Pharmgate LLC. Zoetis Inc. Pharmgate LLC. Huvepharma. Pharmgate LLC. The affected applications for manufacturing combination drug medicated feeds follow: Animal drug product 036–361 ............. asabaliauskas on DSK3SPTVN1PROD with RULES File No. 045–444 ............. 046–209 ............. CTC Sodium Sulfate (chlortetracycline and sodium sulfate)/ AMPROL PLUS (amprolium and ethopabate). CHLORMAX (chlortetracycline)/DECCOX (decoquinate) ........ CTC (chlortetracycline)/COYDEN (clopidol) ............................ 092–507 ............. 099–006 ............. AUREOMYCIN (chlortetracycline)/ROBENZ (robenidine) ....... TERRAMYCIN (oxytetracycline)/COBAN (monensin) ............. 101–666 ............. TERRAMYCIN (oxytetracycline)/ROBENZ (robenidine) .......... VerDate Sep<11>2014 19:06 Dec 23, 2016 Jkt 241001 PO 00000 Frm 00084 Sponsor Fmt 4700 Sfmt 4700 Zoetis Inc., 333 Portage St., Kalamazoo, Inc.). Zoetis Inc. Huvepharma EOOD, 5th Floor, 3A Nikolay Sophia, Bulgaria (Huvepharma EOOD). Zoetis Inc. Phibro Animal Health Corp., GlenPointe Floor, 300 Frank W. Burr Blvd., Suite 07666 (Phibro Animal Health Corp.). Phibro Animal Health Corp. E:\FR\FM\27DER1.SGM 27DER1 MI 49007 (Zoetis Haytov Str., 1113 Centre East, 3d 21, Teaneck, NJ Federal Register / Vol. 81, No. 248 / Tuesday, December 27, 2016 / Rules and Regulations 94993 File No. Animal drug product Sponsor 104–646 ............. TYLAN (tylosin)/RUMENSIN (monensin) ................................. 110–047 116–044 121–553 138–870 138–941 138–992 138–995 139–192 140–448 140–859 140–954 141–011 141–054 ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. ............. TYLAN (tylosin)/BANMINTH (pyrantel) .................................... LINCOMIX (lincomycin)/BANMINTH (pyrantel) ....................... AUREOMYCIN (chlortetracycline)/COBAN (monensin) .......... TYLAN (tylosin)/RUMENSIN (monensin)/MGA (melengestrol) LINCOMIX (lincomycin)/BANMINTH (pyrantel) ....................... TYLAN (tylosin)/BOVATEC (lasalocid)/MGA (melengestrol) ... TYLAN (tylosin)/MGA (melengestrol) ....................................... TYLAN (tylosin)/MGA (melengestrol) ....................................... TERRAMYCIN (oxytetracycline)/BIO–COX (salinomycin) ....... AUREOMYCIN (chlortetracycline)/BIO–COX (salinomycin) .... LINCOMIX (lincomycin)/SAFE–GUARD (fenbendazole) ......... CTC (chlortetracycline)/DENAGARD (tiamulin) ....................... LINCOMIX (lincomycin)/IVOMEC (ivermectin) ........................ 141–059 ............. 141–147 ............. 141–149 ............. CHLORMAX (chlortetracycline)/BMD (bacitracin) ................... CHLORMAX (chlortetracycline)/DECCOX (decoquinate) ........ TYLAN (tylosin)/RUMENSIN (monensin)/DECCOX (decoquinate). TYLAN (tylosin)/PAYLEAN (ractopamine) ............................... AUREOMYCIN (chlortetracycline)/DECCOX (decoquinate) .... AUREOMYCIN (chlortetracycline)/CATTLYST (laidlomycin) ... TERRAMYCIN (oxytetracycline)/(carbadox) ............................ TYLAN (tylosin)/RUMENSIN (monensin)/OPTAFLEXX (ractopamine). TYLAN (tylosin)/RUMENSIN (monensin)/OPTAFLEXX (ractopamine)/MGA (melengestrol). AUREOMYCIN (chlortetracycline)/BOVATEC (lasalocid) ........ TYLAN (tylosin)/RUMENSIN (monensin)/ZILMAX (zilpaterol) Elanco US Inc., 2500 Innovation Way, Greenfield, IN 46140 (Elanco US Inc.). Phibro Animal Health Corp. Phibro Animal Health Corp. Zoetis Inc. Zoetis Inc. Zoetis Inc. Zoetis Inc. Zoetis Inc. Zoetis Inc. Phibro Animal Health Corp. Zoetis Inc. Intervet, Inc. Elanco US Inc. Merial, Inc., 3239 Satellite Blvd., Bldg. 500, Duluth, GA 30096–4640. Zoetis Inc. Zoetis Inc. Zoetis Inc. 141–172 141–185 141–201 141–211 141–224 ............. ............. ............. ............. ............. 141–233 ............. 141–250 ............. 141–276 ............. 141–280 ............. 200–095 200–096 200–242 200–261 200–262 200–263 200–354 ............. ............. ............. ............. ............. ............. ............. 200–356 200–357 200–358 200–359 200–375 ............. ............. ............. ............. ............. 200–424 ............. 200–427 ............. 200–430 ............. 200–480 ............. 200–530 200–531 200–532 200–533 ............. ............. ............. ............. 200–534 ............. 200–535 ............. asabaliauskas on DSK3SPTVN1PROD with RULES 200–544 ............. 200–547 ............. 200–558 ............. 200–561 ............. 200–562 ............. 200–566 ............. 200–567 ............. VerDate Sep<11>2014 TYLAN (tylosin)/RUMENSIN (monensin)/ZILMAX (zilpaterol)/ MGA (melengestrol). AUREOMYCIN (chlortetracycline)/SACOX (salinomycin) ....... TERRAMYCIN (oxytetracycline)/SACOX (salinomycin) .......... AUREOMYCIN (chlortetracycline)/BMD (bacitracin) ............... CHLORMAX (chlortetracycline)/BIO–COX (salinomycin) ........ CHLORMAX (chlortetracycline)/SACOX (salinomycin) ........... CHLORMAX (chlortetracycline)/COBAN (monensin) .............. PENNCHLOR (chlortetracycline)/COBAN (monensin) ............ PENNCHLOR (chlortetracycline)/DENAGARD (tiamulin) ........ PENNCHLOR (chlortetracycline)/BIO–COX (salinomycin) ...... PENNCHLOR (chlortetracycline)/BMD (bacitracin) ................. PENNCHLOR (chlortetracycline)/DECCOX (decoquinate) ...... TYLAN (tylosin)/RUMENSIN (monensin)/HEIFERMAX (melengestrol). TYLAN (tylosin)/RUMENSIN (monensin)/OPTAFLEXX (ractopamine)/HEIFERMAX (melengestrol). TYLAN (tylosin)/HEIFERMAX 500 (melengestrol) Liquid ........ TYLAN (tylosin)/BOVATEC (lasalocid)/HEIFERMAX 500 (melengestrol) Liquid. TYLAN (tylosin)/RUMENSIN (monensin)/ZILMAX (zilpaterol)/ HEIFERMAX 500 (melengestrol). TYLOVET (tylosin)/PAYLEAN (ractopamine) .......................... TYLOVET (tylosin)/RUMENSIN (monensin) ............................ TYLOVET (tylosin)/MGA (melengestrol) .................................. TYLOVET (tylosin)/RUMENSIN (monensin)/DECCOX (decoquinate). TYLOVET (tylosin)/RUMENSIN (monensin)/MGA (melengestrol). TYLOVET (tylosin)/BOVATEC (lasalocid)/MGA (melengestrol). TYLOVET (tylosin)/RUMENSIN (monensin)/ZILMAX (zilpaterol)/MGA (melengestrol). TYLOVET (tylosin)/RUMENSIN (monensin)/ZILMAX (zilpaterol). TYLAN (tylosin)/ENGAIN (ractopamine) .................................. TYLAN (tylosin)/RUMENSIN (monensin)/ACTOGAIN (ractopamine). TYLAN (tylosin)/RUMENSIN (monensin)/ACTOGAIN (ractopamine). TYLOVET (tylosin)/RUMENSIN (monensin) ............................ TYLOVET (tylosin)/RUMENSIN (monensin) ............................ 19:06 Dec 23, 2016 Jkt 241001 PO 00000 Frm 00085 Fmt 4700 Sfmt 4700 Elanco US Inc. Zoetis Inc. Zoetis Inc. Phibro Animal Health Corp. Elanco US Inc. Elanco US Inc. Zoetis Inc. Intervet, Inc., 2 Giralda Farms, Madison, NJ 07940 (Intervet, Inc.). Intervet, Inc. Huvepharma EOOD. Huvepharma EOOD. Zoetis Inc. Zoetis Inc. Zoetis Inc. Zoetis Inc. Pharmgate LLC, 1015 Ashes Dr., Suite 102, Wilmington, NC 28405 (Pharmgate LLC). Pharmgate LLC. Pharmgate LLC. Pharmgate LLC. Pharmgate LLC. Elanco US Inc. Elanco US Inc. Elanco US Inc. Elanco US Inc. Elanco US Inc. Huvepharma Huvepharma Huvepharma Huvepharma EOOD. EOOD. EOOD. EOOD. Huvepharma EOOD. Huvepharma EOOD. Huvepharma EOOD. Huvepharma EOOD. Zoetis Inc. Zoetis Inc. Zoetis Inc. Huvepharma EOOD. Huvepharma EOOD. E:\FR\FM\27DER1.SGM 27DER1 94994 Federal Register / Vol. 81, No. 248 / Tuesday, December 27, 2016 / Rules and Regulations File No. Animal drug product 200–583 ............. TYLOVET (tylosin)/RUMENSIN (monensin)/ACTOGAIN (ractopamine)/MGA (melengestrol). TYLOVET (tylosin)/ENGAIN (ractopamine) ............................. TYLOVET (tylosin)/RUMENSIN (monensin)/ACTOGAIN (ractopamine). 200–584 ............. 200–585 ............. 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 ANADAs changing the marketing status of antimicrobial drugs administered to food-producing animals in medicated water. Sponsor Zoetis Inc. Zoetis Inc. Zoetis Inc. II. Changes of Sponsorship Elanco US Inc., 2500 Innovation Way, Greenfield, IN 46140 has informed FDA that it has transferred ownership of, and all rights and interest in, NADA 141– 110, providing for the manufacture of combination drug medicated turkey feeds containing STAFAC (virginiamycin) and COBAN (monensin) to Phibro Animal Health Corp., GlenPointe Centre East, 3d Floor, 300 Frank W. Burr Blvd., Suite 21, Teaneck, NJ 07666. As provided in the regulatory text of this document, the animal drug regulations are amended to reflect this change of sponsorship. III. Withdrawals of Approval In addition, approval of the following applications for medicated feeds containing antimicrobial drugs of importance to human medicine administered to food-producing animals is being withdrawn at the sponsors’ requests because the products are no longer manufactured or marketed: File No. Product name Sponsor 034–085 ............. LINCOMIX (lincomycin hydrochloride monohydrate) Type A Medicated Article. OM–5 Premix (oleandomycin) Type A Medicated Article ........ Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007 (Zoetis Inc.). Phibro Animal Health Corp., GlenPointe Centre East, 3d Floor, 300 Frank W. Burr Blvd., Suite 21, Teaneck, NJ 07666 (Phibro Animal Health Corp.). Phibro Animal Health Corp. Zoetis Inc. 035–287 ............. 046–668 ............. 091–668 ............. 140–443 ............. 140–947 ............. Penicillin G Procaine 50% Type A Medicated Article .............. CHLORMAX–SP 500 (chlortetracycline, sulfamethazine, penicillin G procaine) Type A Medicated Article. LINCOMIX (lincomycin)/NICARB (nicarbazin) ......................... Virginiamycin Type A Medicated Article .................................. STAFAC (virginiamycin)/STENEROL (halofuginone hydrobromide). LINCOMIX (lincomycin)/STENOROL (halofuginone hydrobromide). HYGROMIX 1.6 (hygromycin B) Type A Medicated Article .... LINCOMIX (lincomycin)/MAXIBAN (narasin and nicarbazin) .. 141–090 ............. 200–171 ............. STAFAC (virginiamycin)/CLINICOX (diclazuril) ....................... LINCOMIX (lincomycin)/NICARMIX (nicarbazin) ..................... 200–569 ............. 200–570 ............. 200–580 ............. TYLAN (tylosin)/SACOX (salinomycin) .................................... TYLOVET 100 (tylosin)/BIO–COX (salinomycin) ..................... TYLOVET 100 (tylosin)/SACOX (salinomycin) ........................ 108–116 ............. 133–334 ............. 139–473 ............. asabaliauskas on DSK3SPTVN1PROD with RULES 140–340 ............. Elsewhere in this issue of the Federal Register, FDA gave notice that approval of NADAs 034–085, 035–287, 046–668, 091–668, 108–116, 133–334, 139–473, 140–340, 140–443, 140–947, and 141– 090, and ANADAs 200–171, 200–569, 200–570, and 200–580, and all supplements and amendments thereto, is withdrawn, effective January 6, 2017. As provided in the regulatory text of this document, the animal drug regulations are amended to reflect these voluntary withdrawals of approval. 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. VerDate Sep<11>2014 19:06 Dec 23, 2016 Jkt 241001 Phibro Animal Health Corp. Zoetis Inc. Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str., 1113 Sophia, Bulgaria (Huvepharma EOOD). Huvepharma EOOD. Zoetis Inc. Elanco US Inc., 2500 Innovation Way, Greenfield, IN 46140 (Elanco US Inc.). Huvepharma EOOD. Planalquimica Industrial Ltda., Rua das Magnolias nr. 2405, Jardim das Bandeiras, CEP 13053–120, Campinas, Sao Paulo, Brazil. Huvepharma EOOD. Huvepharma EOOD. Huvepharma EOOD. List of Subjects PART 556—TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD 21 CFR Part 556 Animal drugs, Foods. 1. The authority citation for part 556 continues to read as follows: ■ 21 CFR Part 558 Authority: 21 U.S.C. 342, 360b, 371. Animal drugs, Animal feeds. 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 556 and 558 are amended as follows: PO 00000 § 556.480 ■ [Removed] 2. Remove § 556.480. PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS 3. The authority citation for part 558 continues to read as follows: ■ Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc–1, 371. Frm 00086 Fmt 4700 Sfmt 4700 E:\FR\FM\27DER1.SGM 27DER1 94995 Federal Register / Vol. 81, No. 248 / Tuesday, December 27, 2016 / Rules and Regulations 4. In § 558.4, in paragraph (d), in the Category I table, in the column headings for ‘‘Assay limits 1 percent type A’’ and ‘‘Assay limits percent 1 type B/C 2’’, remove ‘‘type’’ and in its place add ■ § 558.4 Requirement of a medicated feed mill license. ‘‘Type’’, and remove the row entries for ‘‘Erythromycin (thiocyanate salt)’’ and ‘‘Oleandomycin’’; and in the Category II table, alphabetically add an entry for ‘‘Erythromycin’’ to read as follows: * * * (d) * * * * * CATEGORY II Assay limits percent 1 Type A Drug * * Erythromycin .................................... * * * * 85–115 * * * * * * Amprolium and ethopabate. * * * * (f) Amprolium and ethopabate may also be used in combination with: (1) [Reserved] (2) [Reserved] (3) Chlortetracycline as in § 558.128. (4) Lincomycin as in § 558.325. (5) Virginiamycin as in § 558.635. ■ 6. Revise § 558.59 to read as follows: 5. In § 558.58, remove and reserve paragraphs (e)(2), (7), and (8); remove paragraphs (e)(10) and (11); and add paragraph (f) to read as follows: * Assay limits percent 1 Type B/C 2 * * * 4.625 g/lb (1.02%) ..................................................................................... * ■ § 558.58 Type B maximum (100×) * § 558.59 * 75–125 * Apramycin. (a) Specifications. Type A articles containing 75 grams apramycin (as apramycin sulfate) per pound. (b) Sponsor. See No. 058198 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.52 of this chapter. (d) Conditions of use in swine— Apramycin grams/ton Combination in grams/ton Indications for use Limitations (1) 150 ................... ........................ For control of porcine colibacillosis (weanling pig scours) caused by susceptible strains of Escherichia coli. Feed as the sole ration for 14 consecutive days. Withdraw 28 days before slaughter. Sponsor 058198 (2) [Reserved]. 7. In § 558.76, redesignate paragraphs (e)(2)(iii) through (xvi) as paragraphs (e)(2)(iv) through (xvii); and add new paragraph (e)(2)(iii) to read as follows: ■ § 558.76 Bacitracin methylenedisalicylate. * * * * * (e) * * * (2) * * * (iii) Chlortetracycline as in § 558.128. * * * * * ■ 8. Revise § 558.128 to read as follows: § 558.128 Chlortetracycline. asabaliauskas on DSK3SPTVN1PROD with RULES (a) Specifications. Type A medicated articles containing either chlortetracycline calcium complex equivalent to chlortetracycline hydrochloride, or for products intended for use in milk replacer, chlortetracycline hydrochloride. (b) Approvals. See sponsors in § 510.600(c) of this chapter for use as in paragraph (e) of this section. (1) Nos. 054771: 50, 65, or 100 grams per pound (g/lb) Type A medicated article. (2) No. 066104: 10, 20, 30, 50, 70, or 100 g/lb of Type A medicated article. (3) No. 069254: 50, 90, or 100 g/lb of Type A medicated article. (c) Related tolerances. See § 556.150 of this chapter. (d) Special considerations—(1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian. See § 558.6 for additional requirements. (2) The expiration date of VFDs for chlortetracycline medicated feeds must not exceed 6 months from the date of issuance. VFDs for chlortetracycline shall not be refilled. (3) In milk replacers or starter feed; include on labeling the warning: ‘‘A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.’’ (4) Manufacture for use in free-choice feeds as in paragraph (e)(4)(iii) of this section must conform to § 510.455 of this chapter. (5) When manufactured for use as in paragraph (e)(5)(iii) of this section, include on labeling the warning: ‘‘Psittacosis, avian chlamydiosis, or ornithosis is a reportable communicable disease, transmissible between wild and domestic birds, other animals, and man. Contact appropriate public health and regulatory officials.’’ (e) Conditions of use—(1) Chickens. It is used as follows: Chlortetracycline amount Combination in grams/ton Indications for use Limitations (i) 100 to 200 g/ton ................................ Chickens: For control of infectious synovitis caused by Mycoplasma synoviae susceptible to chlortetracycline. Feed continuously for 7 to 14 days. Do not feed to chickens producing eggs for human consumption. VerDate Sep<11>2014 19:06 Dec 23, 2016 Jkt 241001 PO 00000 Frm 00087 Fmt 4700 Sfmt 4700 E:\FR\FM\27DER1.SGM 27DER1 Sponsor 054771 066104 069254 94996 Federal Register / Vol. 81, No. 248 / Tuesday, December 27, 2016 / Rules and Regulations Combination in grams/ton Indications for use Limitations (ii) 100 to 200 g/ton Clopidol, 113.5 ....... Broiler and replacement chickens: As an aid in the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. mivati, and E. brunetti; and for control of infectious synovitis caused by M. synoviae susceptible to chlortetracycline. (iii) 100 to 200 g/ton Decoquinate, 27.2 .. Chickens: For prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. mivati, E. acervulina, E. maxima, and E. brunetti; and for control of infectious synovitis caused by M, synoviae susceptible to chlortetracycline. (iv) 100 g/ton .......... Robenidine, 30 ...... ................................ (vi) 200 g/ton .......... Amprolium, 227 and ethopabate, 3.6. Broiler and fryer chickens: As an aid in the prevention of coccidiosis caused by E. mivati, E. brunetti, E. tenella, E. acervulina, E. maxima, and E. necatrix; as an aid in the control of chronic respiratory disease (CRD) caused by Mycoplasma gallisepticum susceptible to chlortetracycline; and as an aid in the control of infectious synovitis caused by M. synoviae susceptible to chlortetracycline. Chickens: For the control of chronic respiratory disease (CRD) and air sac infection caused by M. gallisepticum and Escherichia coli susceptible to chlortetracycline. For chickens where immunity to coccidiosis is not desired: For prevention of coccidiosis; and for treatment of chronic respiratory disease (CRD) caused by M. gallisepticum susceptible to chlortetracycline. Feed continuously as the sole ration from the time chicks are placed in floor pens for 7 to 14 days. Do not feed to chickens over 16 weeks of age. Do not feed to chickens producing eggs for human consumption. Chlortetracycline as provided by No. 054771; clopidol as provided by No. 016592 in § 510.600(c) of this chapter. Feed continuously for 7 to 14 days. Bentonite should not be used in decoquinate feeds. Do not feed to chickens producing eggs for human consumption. Chlortetracycline and decoquinate as provided by No. 054771 in § 510.600(c) of this chapter. Feed continuously as sole ration. Do not use this product in feeds conta. Chlortetracycline and robenidine as provided by No. 054771 in § 510.600(c) of this chapter. (v) 200 to 400 g/ton (vii) 200 g/ton ......... Decoquinate, 27.2 .. Broilers: As an aid in the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. mivati, E. maxima, and E. brunetti; and for the treatment of chronic respiratory disease (air sac infection) and the prevention of synovitis. (viii) 200 g/ton ........ asabaliauskas on DSK3SPTVN1PROD with RULES Chlortetracycline amount Robenidine 30 ....... (ix) 500 g/ton .......... ................................ Broiler and fryer chickens: As an aid in the prevention of coccidiosis caused by E. mivati, E. brunetti, E. tenella, E. acervulina, E. maxima, and E. necatrix; as an aid in the control of chronic respiratory disease (CRD) caused by M. gallisepticum susceptible to chlortetracycline; and as an aid in the control of infectious synovitis caused by M. synoviae susceptible to chlortetracycline. Chickens: For the reduction of mortality due to E. coli infections susceptible to chlortetracycline. VerDate Sep<11>2014 19:06 Dec 23, 2016 Jkt 241001 PO 00000 Frm 00088 Fmt 4700 Sfmt 4700 Sponsor 016592 054771 054771 Feed continuously for 7 to 14 days. Do not feed to chickens producing eggs for human consumption. 054771 066104 069254 Use in low calcium feed containing 0.8% dietary calcium and 1.5% sodium sulfate; feed continuously as sole ration for 7 to 14 days; do not feed to chickens producing eggs for human consumption. Chlortetracycline as provided by No. 054771; amprolium and ethopabate as provided by No. 016592 in § 510.600(c) of this chapter. Feed continuously as the sole ration for no more than 8 weeks. Use in low calcium feed containing 0.8% dietary calcium. Bentonite should not be used in decoquinate feeds. Do not feed to chickens producing eggs for human consumption. Chlortetracycline and decoquinate as provided by No. 054771 in § 510.600(c) of this chapter. Feed continuously as sole ration. Do not use this product in feeds containing bentonite. Do not feed to chickens producing eggs for human consumption. Withdraw 5 days prior to slaughter. Chlortetracycline and robenidine as provided by No. 054771 in § 510.600(c) of this chapter. 054771 1. Feed for 5 days. To sponsor No. 054771 under NADA 048–761 and No. 069254 under ANADA 200–510: zero withdrawal time. 2. Feed for 5 days; withdraw 24 hours prior to slaughter. Do not feed to chickens producing eggs for human consumption. E:\FR\FM\27DER1.SGM 27DER1 054771 054771 054771 069254 054771 066104 069254 Federal Register / Vol. 81, No. 248 / Tuesday, December 27, 2016 / Rules and Regulations Chlortetracycline amount Combination in grams/ton Indications for use Limitations Feed for 5 days as the sole ration. Do not feed to laying chickens. Not to be fed continuously for more than 5 days. Do not feed to chickens over 16 weeks of age. Withdraw 24 hours before slaughter. See § 558.355(d) of this chapter. Chlortetracycline as provided by No. 054771; monensin as provided by No. 058198 in § 510.600(c) of this chapter. Feed continuously as sole ration for up to 5 days. Do not use this product in feeds containing bentonite. Do not feed to chickens producing eggs for human consumption. Withdraw 5 days prior to slaughter. Chlortetracycline and robenidine as provided by No. 054771 in § 510.600(c) of this chapter. For use in low calcium feeds containing 0.8% calcium. Not approved for use with pellet binders. Not to be fed continuously for more than 5 days. Do not feed to laying chickens producing eggs for human consumption. Withdraw 24 hours before slaughter. May be fatal if accidentally fed to adult turkeys or horses. Chlortetracycline as provided by Nos. 054771 or 069254; salinomycin as provided by Nos. 054771 or 016592 in § 510.600(c) of this chapter. (x) 500 g/ton ........... Monensin, 90 to 110. Chickens: As an aid in the reduction of mortality due to E. coli infections susceptible to chlortetracycline; and as an aid in the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati. (xi) 500 g/ton .......... Robenidine, 30 ...... Broiler and fryer chickens: As an aid in the prevention of coccidiosis caused by Eimeria mivati, E. brunetti, E. tenella, E. acervulina, E. maxima, and E. necatrix; as an aid in the reduction of mortality due to E. coli susceptible to chlortetracycline. (xii) 500 g/ton ......... Salinomycin, 40 to 60. Broiler chickens: As an aid in the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati; and as an aid in the reduction of mortality due to E. coli susceptible to chlortetracycline. 94997 Sponsor 054771 069254 054771 016592 054771 069254 (2) Turkeys. It is used as follows: Chlortetracycline amount Combination in grams/ton Indications for use Limitations (i) 200 g/ton ............ ................................ (ii) 400 g/ton ........... ................................ ................................ ................................ Feed continuously for 7 to 14 days. Do not feed to turkeys producing eggs for human consumption. Feed continuously for 7 to 14 days. Do not feed to turkeys producing eggs for human consumption. ................................................................ 054771 066104 069254 054771 066104 069254 054771 066104 069254 (iii) 25 mg/lb of body weight. ................................ Turkeys: For control of infectious synovitis caused by M. synoviae susceptible to chlortetracycline. 1. Turkeys: For control of hexamitiasis caused by Hexamita meleagridis susceptible to chlortetracycline. 2. Turkey poults not over 4 weeks of age: For reduction of mortality due to paratyphoid caused by Salmonella typhimurium susceptible to chlortetracycline. Turkeys: For control of complicating bacterial organisms associated with bluecomb (transmissible enteritis; coronaviral enteritis) susceptible to chlortetracycline. Feed continuously for 7 to 14 days. Do not feed to turkeys producing eggs for human consumption. 054771 066104 069254 Sponsor (3) Swine. It is used as follows: asabaliauskas on DSK3SPTVN1PROD with RULES Chlortetracycline amount Combination in grams/ton Indications for use Limitations (i) 50 to 100 g/ton .. ................................ Swine: For reducing the incidence of cervical lymphadenitis (jowl abscesses) caused by Group E Streptococci susceptible to chlortetracycline. ................................................................ VerDate Sep<11>2014 19:06 Dec 23, 2016 Jkt 241001 PO 00000 Frm 00089 Fmt 4700 Sfmt 4700 E:\FR\FM\27DER1.SGM 27DER1 Sponsor 054771 066104 069254 94998 Federal Register / Vol. 81, No. 248 / Tuesday, December 27, 2016 / Rules and Regulations Chlortetracycline amount Combination in grams/ton Indications for use Limitations (ii) 400 g/ton ........... ................................ Feed continuously for not more than 14 days. 054771 066104 069254 (iii) 10 mg/lb of body weight. ................................ Feed approximately 400 g/ton, varying with body weight and feed consumption to provide 10 mg/lb per day. Feed for not more than 14 days. Withdraw 5 d prior to slaughter for sponsor No. 069254 in § 510.600(c) of this chapter. 054771 066104 069254 (iv) 10 mg/lb of body weight. Bacitracin methylenedisalicylate, 10 to 30. Feed approximately 400 g/ton, varying with body weight and feed consumption to provide 10 mg/lb per day. Feed for not more than 14 days. 054771 (v) 10 mg/lb of body weight. Bacitracin methylenedisalicylate, 10 to 30. Breeding swine: For the control of leptospirosis (reducing the incidence of abortion and shedding of leptospirae) caused by Leptospira pomona susceptible to chlortetracycline. Swine: For treatment of bacterial enteritis caused by Escherichia coli and S. choleraesuis and bacterial pneumonia caused by Pasteurella multocida susceptible to chlortetracycline; for the control of porcine proliferative enteropathies (ileitis) caused by Lawsonia intracellularis susceptible to chlortetracycline. Swine: For treatment of bacterial enteritis caused by E. coli and S. choleraesuis and bacterial pneumonia caused by P. multocida susceptible to chlortetracycline; for the control of porcine proliferative enteropathies (ileitis) caused by Lawsonia intracellularis susceptible to chlortetracycline; and for increased rate of weight gain and improved feed efficiency. Swine: For treatment of bacterial enteritis caused by E. coli and S. choleraesuis and bacterial pneumonia caused by P. multocida susceptible to chlortetracycline; and for increased rate of weight gain and improved feed efficiency. 069254 (vi) 500 to 4,000 to provide 10 mg/lb of body weight daily. Tiamulin hydrogen fumarate, 35. Feed chlortetracycline at approximately 400 g/ton of feed, varying with body weight and food consumption, to provide 10 mg/lb of body weight. Feed for not more than 14 days. Withdraw 5 d prior to slaughter for sponsor No. 069254. Bacitracin methylenedisalicylate provided by No. 054771; chlortetracycline provided by Nos. 054771 and 069254 in § 510.600(c) of this chapter. Feed continuously as the sole ration for 14 days. Withdraw medicated feed 2 days before slaughter. Tiamulin as provided by Nos. 058198 or 069254in § 510.600(c) of this chapter. For control of swine dysentery associated with Brachyspira (formerly Serpulina or Treponema) hyodysenteriae susceptible to tiamulin and for treatment of swine bacterial enteritis caused by E. coli and Salmonella choleraesuis sensitive to chlortetracycline and treatment of bacterial pneumonia caused by P. multocida sensitive to chlortetracycline. Sponsor 058198 069254 (4) Cattle. It is used as follows: Combination in grams/ton Indications for use Limitations (i) 0.5 mg/lb of body weight daily. asabaliauskas on DSK3SPTVN1PROD with RULES Chlortetracycline amount ................................ Beef cattle (over 700 lb): For control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline. Withdraw 48 hours prior to slaughter. To sponsor Nos. 054771 and 069254: Zero withdrawal time. VerDate Sep<11>2014 19:06 Dec 23, 2016 Jkt 241001 PO 00000 Frm 00090 Fmt 4700 Sfmt 4700 E:\FR\FM\27DER1.SGM 27DER1 Sponsor 054771 066104 069254 Federal Register / Vol. 81, No. 248 / Tuesday, December 27, 2016 / Rules and Regulations Chlortetracycline amount Combination in grams/ton Indications for use Limitations Feed continuously on a hand-fed basis 0.5 mg chlortetracycline per lb. body weight per day and not less than 60 mg or more than 300 mg lasalocid per head daily in at least 1 pound of feed. Daily lasalocid intakes in excess of 200 mg/head/day in pasture cattle have not been shown to be more effective than 200 mg lasalocid/head/ day. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter. In free-choice cattle feeds such as feed blocks or salt-mineral mixes manufactured from approved Type A articles. See paragraph (d)(4) of this section. 054771 Feed approximately 400 g/ton, varying with body weight and feed consumption to provide 10 mg/lb per day. Treat for not more than 5 days. In feed including milk replacers withdraw 10 days prior to slaughter. To sponsor No. 069254: zero withdrawal time. See paragraph (d)(3) of this section. See paragraph (d)(3) of this section ...... 054771 066104 069254 (ii) 25 to 1,100 to provide 0.5 mg/lb of body weight daily. Lasalocid, 30 to 600. Pasture cattle (slaughter, stocker, feeder cattle, beef replacement heifers) over 700 pounds: For control of active infection of anaplasmosis caused by A. marginale susceptible to chlortetracycline; and for increased rate of weight gain. (iii) 0.5 to 2.0 mg/lb of body weight daily. ................................ (iv) 10 mg/lb of body weight daily. ................................ Beef cattle and nonlactating dairy cattle: As an aid in the control of active infection of anaplsmosis caused by A. marginale susceptible to chlortetracycline. 1. Calves, beef and nonlactating dairy cattle: For treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida organisms susceptible to chlortetracycline. Laidlomycin, 5 ........ (vi) 10 mg/lb of body weight daily. Laidlomycin, 5 to 10 (vii) 500 to 2,000 to provide 10 mg/lb of body weight daily. asabaliauskas on DSK3SPTVN1PROD with RULES (v) 10 mg/lb of body weight daily. Lasalocid, 10 to 30 VerDate Sep<11>2014 19:06 Dec 23, 2016 Jkt 241001 94999 2. Calves (up to 250 lb): For the treatment of bacterial enteritis caused by E. coli susceptible to chlortetracycline. Cattle fed in confinement for slaughter: Feed continuously at a rate of 30 to 75 For treatment of bacterial enteritis mg laidlomycin propionate potassium caused by E. coli and bacterial pneuper head per day for not more than 5 monia caused by P. multocida orgadays. A withdrawal period has not nisms susceptible to chlortetracycline; been established for this product in and for increased rate of weight and pre-ruminating calves. Do not use in improved feed efficiency. calves to be processed for veal. See § 558.305(d) of this chapter. Laidlomycin as provided by No. 054771 in § 510.600(c) of this chapter. Cattle fed in confinement for slaughter: Feed continuously at a rate of 30 to 75 For treatment of bacterial enteritis mg laidlomycin propionate potassium caused by E. coli and bacterial pneuper head per day for not more than 5 monia caused by P. multocida orgadays. A withdrawal period has not nisms susceptible to chlortetracycline; been established for this product in and for improved feed efficiency. pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.305(d) of this chapter. Laidlomycin as provided by No. 054771 in § 510.600(c) of this chapter. Cattle fed in confinement for slaughter: Feed continuously in complete feed for For treatment of bacterial enteritis not more than 5 days to provide 10 caused by E. coli and bacterial pneumg chlortetracycline per lb. body monia caused by P. multocida orgaweight per day and not less than 100 nisms susceptible to chlortetracycline; mg or more than 360 mg lasalocid and for improved feed efficiency. per head per day. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter. PO 00000 Frm 00091 Fmt 4700 Sfmt 4700 E:\FR\FM\27DER1.SGM 27DER1 Sponsor 054771 054771 066104 069254 054771 054771 054771 95000 Federal Register / Vol. 81, No. 248 / Tuesday, December 27, 2016 / Rules and Regulations Combination in grams/ton Indications for use Limitations (viii) 500 to 1,200 to provide 10 mg/lb of body weight daily. Lasalocid, 25 to 30 Cattle fed in confinement for slaughter: For treatment of bacterial enteritis caused by E. coli and bacterial pneumonia caused by P. multocida organisms susceptible to chlortetracycline; and for increased rate of weight gain and improved feed efficiency. (ix) 500 to 4,000 to provide 10 mg/lb of body weight daily. Lasalocid, 30 to 600. Pasture cattle (slaughter, stocker, feeder cattle, dairy and beef replacement heifers): For treatment of bacterial enteritis caused by E. coli and bacterial pneumonia caused by P. multocida organisms susceptible to chlortetracycline; and for increased rate of weight gain and improved feed efficiency. (x) 500 to 4,000 g/ ton. ................................ Calves, beef and nonlactating dairy cattle: For the treatment of bacterial enteritis caused by E. coli and bacterial pneumonia caused by P. multocida susceptible to chlortetracycline. (xi) 500 to 4,000 ..... Decoquinate, 12.9 to 90.8. Calves, beef and non-lactating dairy cattle: For the treatment of bacterial enteritis caused by E. coli and bacterial pneumonia caused by P. multocida susceptible to chlortetracycline; and for the prevention of coccidiosis caused by Eimeria bovis and E. zuernii. (xii) 4,000 to 20,000 g/ton. asabaliauskas on DSK3SPTVN1PROD with RULES Chlortetracycline amount ................................ Calves, beef and nonlactating dairy cattle: For the treatment of bacterial enteritis caused by E. coli and bacterial pneumonia caused by P. multocida organisms susceptible to chlortetracycline. Feed continuously in complete feed for not more than 5 days to provide 10 mg chlortetracycline per lb. body weight per day and not less than 250 mg or more than 360 mg lasalocid per head per day. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter. Feed continuously on a hand-fed basis for not more than 5 days to provide 10 mg chlortetracycline per lb. body weight per day and not less than 60 mg or more than 300 mg lasalocid per head per day. Daily lasalocid intakes in excess of 200 mg/head/day in pasture cattle have not been shown to be more effective than 200 mg lasalocid/head/day. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter. Feed continuously for not more than 5 days to provide 10 mg/lb body weight per day. To sponsor No. 054771 under NADA 046–699: 24-hour withdrawal period. To sponsor No. 054771 under NADA 048–761 and No. 069254 under ANADA 200–510: Zero withdrawal period. Feed at a rate of 1g chlortetracycline per 100 lb body weight/day and 22.7 mg decoquinate per 100 lb of body weight/day for not more than 5 days. When it is fully consumed, resume feeding 22.7 mg decoquinate per 100 lb of body weight/day for a total of 28 days to prevent coccidiosis. Withdraw 24 hours prior to slaughter. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. Do not feed to animals producing milk for food. Decoquinate as provided by No. 054771 in § 510.600(c) of this chapter. As a top dress, varying with body weight and feed consumption, to provide 10 mg/lb per day. Treat for not more than 5 days. See paragraph (d)(3) of this section. VerDate Sep<11>2014 19:06 Dec 23, 2016 Jkt 241001 PO 00000 Frm 00092 Fmt 4700 Sfmt 4700 E:\FR\FM\27DER1.SGM 27DER1 Sponsor 054771 054771 054771 069254 054771 069254 054771 Federal Register / Vol. 81, No. 248 / Tuesday, December 27, 2016 / Rules and Regulations Chlortetracycline amount Combination in grams/ton Indications for use Limitations Administer as a top dress supplement or mix into the daily ration to provide 22.7 mg decoquinate per 100 lb of body weight per day and 1 g chlortetracycline per 100 lb body weight/ day for not more than 5 days. When it is fully consumed, resume feeding 22.7 mg decoquinate per 100 lb of body weight/day for a total of 28 days to prevent coccidiosis. Withdraw 24 hours prior to slaughter. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. Do not feed to animals producing milk for food. Decoquinate as provided by No. 054771 in § 510.600(c) of this chapter. See paragraph (d)(3) of this section ...... (xiii) 4,000 to 20,000 g/ton. Decoquinate, 90.8 to 535.7. Calves, beef and non-lactating dairy cattle: For the treatment of bacterial enteritis caused by E. coli and bacterial pneumonia caused by P. multocida susceptible to chlortetracycline; and for the prevention of coccidiosis caused by E. bovis and E. zuernii. (xiv) 70 mg/head/ day. ................................ Growing cattle (over 400 lb): For reduction of incidence of liver abscesses. (xv) 350 mg/head/ day. ................................ 1. Beef cattle: For control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetracycline. 2. Beef cattle (under 700 lb): For control of active infection of anaplasmosis caused by A. marginale susceptible to chlortetracycline. Laidlomycin, 5 ........ Cattle fed in confinement for slaughter: For control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetracycline; and for increased rate of weight and improved feed efficiency. (xvii) 350 mg/head/ day. Laidlomycin, 5 to 10 Cattle fed in confinement for slaughter: For control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetracycline; and for improved feed efficiency. (xviii) 25 to 42.2 g/ ton to provide 350 mg/head/day. asabaliauskas on DSK3SPTVN1PROD with RULES (xvi) 350 mg/head/ day. Lasalocid, 25 to 30 Cattle under 700 pounds fed in confinement for slaughter: For control of active infection of anaplasmosis caused by A. marginale susceptible to chlortetracycline; and for increased rate of weight gain and improved feed efficiency. VerDate Sep<11>2014 19:06 Dec 23, 2016 Jkt 241001 PO 00000 Frm 00093 Fmt 4700 Sfmt 4700 Withdraw 48 h prior to slaughter. To sponsor No. 054771 under NADA 046–699: 48-hour withdrawal time. To sponsor No. 054771 under NADA 048–761 and No. 069254 under ANADA 200–510: zero withdrawal period. Withdraw 48 h prior to slaughter. To sponsor No. 054771 under NADA 046–699: 48-hour withdrawal time. To sponsor No. 054771 under NADA 048–761 and No. 069254 under ANADA 200–510: zero withdrawal time. Feed continuously at a rate of 30 to 75 mg laidlomycin propionate potassium per head per day. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.305(d) of this chapter. Laidlomycin as provided by No. 054771 in § 510.600(c) of this chapter. Feed continuously at a rate of 30 to 75 mg laidlomycin propionate potassium per head per day. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.305(d) of this chapter. Laidlomycin as provided by No. 054771 in § 510.600(c) of this chapter. Feed continuously in complete feed at a rate of 350 mg chlortetracycline and not less than 250 mg nor more than 360 mg lasalocid per head daily. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter. E:\FR\FM\27DER1.SGM 27DER1 95001 Sponsor 054771 054771 066104 069254 054771 066104 069254 054771 066104 069254 054771 054771 054771 95002 Federal Register / Vol. 81, No. 248 / Tuesday, December 27, 2016 / Rules and Regulations Combination in grams/ton Indications for use Limitations (xix) 25 to 42.2 g/ ton to provide 350 mg/head/day. Lasalocid, 25 to 30 Cattle fed in confinement for slaughter: For control of bacterial pneumonia associated with shipping fever complex caused by P. multocida organisms susceptible to chlortetracycline; and for increased rate of weight gain and improved feed efficiency. (xx) 25 to 100 g/ton to provide 350 mg/head/day. Lasalocid, 10 to 30 Cattle under 700 pounds fed in confinement for slaughter: For control of active infection of anaplasmosis caused by A. marginale susceptible to chlortetracycline; and for improved feed efficiency. (xxi) 25 to 100 g/ton to provide 350 mg/head/day. Lasalocid, 10 to 30 Cattle fed in confinement for slaughter: For control of bacterial pneumonia associated with shipping fever complex caused by P. multocida organisms susceptible to chlortetracycline; and for improved feed efficiency. (xxii) 25 to 700 to provide 350 mg/ head/day. asabaliauskas on DSK3SPTVN1PROD with RULES Chlortetracycline amount Lasalocid, 30 to 600. Pasture cattle (slaughter, stocker, feeder cattle, dairy and beef replacement heifers): For control of bacterial pneumonia associated with shipping fever complex caused by P. multocida organisms susceptible to chlortetracycline; and for increased rate of weight gain. Feed continuously in complete feed at a rate of 350 mg chlortetracycline and not less than 250 mg nor more than 360 mg lasalocid per head daily. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter. Feed continuously in complete feed at a rate of 350 mg chlortetracycline and not less than 100 mg nor more than 360 mg lasalocid per head daily. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter. Feed continuously in complete feed at a rate of 350 mg chlortetracycline and not less than 100 mg nor more than 360 mg lasalocid per head daily. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter. Feed continuously on a hand-fed basis at a rate of 350 mg chlortetracycline and not less than 60 mg nor more than 300 mg lasalocid per head per day in at least 1 pound of feed. Daily lasalocid intakes in excess of 200 mg/head/day in pasture cattle have not been shown to be more effective than 200 mg lasalocid/head/day. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter. VerDate Sep<11>2014 19:06 Dec 23, 2016 Jkt 241001 PO 00000 Frm 00094 Fmt 4700 Sfmt 4700 E:\FR\FM\27DER1.SGM 27DER1 Sponsor 054771 054771 054771 054771 Federal Register / Vol. 81, No. 248 / Tuesday, December 27, 2016 / Rules and Regulations Chlortetracycline amount Combination in grams/ton Indications for use Limitations Feed continuously on a hand-fed basis at a rate of 350 mg chlortetracycline and not less than 60 mg nor more than 300 mg lasalocid per head per day in at least 1 pound of feed. Daily lasalocid intakes in excess of 200 mg/head/day in pasture cattle have not been shown to be more effective than 200 mg lasalocid/head/day. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter. Hand feed continuously at a rate of 350 mg chlortetracycline and 1 mg lasalocid per 2.2 lb. body weight daily to cattle with a maximum of 360 mg of lasalocid per head per day. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter. Hand feed continuously at a rate of 350 mg chlortetracycline and 1 mg lasalocid per 2.2 lb. body weight daily to cattle with a maximum of 360 mg of lasalocid per head per day. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter. (xxiii) 25 to 700 to provide 350 mg/ head/day. Lasalocid, 30 to 600. Pasture cattle (slaughter, stocker, feeder cattle, beef replacement heifers) under 700 pounds: For control of active infection of anaplasmosis caused by A. marginale susceptible to chlortetracycline; and for increased rate of weight gain. (xxiv) 25 to 2,800 to provide 350 mg/ head/day. Lasalocid, 30 to 181.8. Beef cattle weighing up to 800 pounds: For control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetracycline; and for the control of coccidiosis caused by E. bovis and E. zuernii. (xxv) 500 to 4,000 to provide 350 mg/head/day. Lasalocid, 30 to 181.8. Cattle weighing up to 800 pounds: For the treatment of bacterial enteritis caused by E. coli and bacterial pneumonia caused by P. multocida susceptible to chlortetracycline; and for the control of coccidiosis caused by E. bovis and E. zuernii. 95003 Sponsor 054771 054771 054771 (5) Minor species. It is used as follows: Chlortetracycline amount (i) 80 mg/head/day asabaliauskas on DSK3SPTVN1PROD with RULES (ii) 200 to 400 g/ton (iii) 10 mg/g of finished feed daily. VerDate Sep<11>2014 Indications for use Limitations Breeding sheep; reducing the incidence of (vibrionic) abortion caused by Campylobacter fetus infection susceptible to chlortetracycline. Ducks: For the control and treatment of fowl cholera caused by Pasteurella multocida susceptible to chlortetracycline. .................................................................................. Psittacine birds (cockatoos, macaws, and parrots) suspected or known to be infected with psittacosis caused by Chlamydia psittaci sensitive to chlortetracycline. 19:06 Dec 23, 2016 Jkt 241001 PO 00000 Frm 00095 Fmt 4700 Feed in complete ration to provide from 8 to 28 mg/lb of body weight per day, depending upon age and severity of disease, for not more than 21 days. Do not feed to ducks producing eggs for human consumption. Feed continuously for 45 days. Each bird should consume daily an amount of medicated feed equal to one fifth of its body weight. See paragraph (d)(5) of this section. Sfmt 4700 E:\FR\FM\27DER1.SGM 27DER1 Sponsor 054771 066104 069254 054771 054771 95004 Federal Register / Vol. 81, No. 248 / Tuesday, December 27, 2016 / Rules and Regulations (6) It is used as a free-choice, loose mineral Type C feed as follows: (i) Specifications. Ingredient Percent Dicalcium Phosphate ................................................................................................................................... Sodium Chloride (Salt) ................................................................................................................................ Magnesium Oxide ........................................................................................................................................ Cottonseed Meal .......................................................................................................................................... Trace Mineral/Vitamin Premix 1 ................................................................................................................... Calcium Carbonate ...................................................................................................................................... Dried Cane Molasses .................................................................................................................................. Potassium Chloride ...................................................................................................................................... Mineral Oil .................................................................................................................................................... Iron Oxide .................................................................................................................................................... Chlortetracycline Type A medicated article (90 gram/lb) ............................................................................ 46.20 15.00 10.67 10.00 3.80 3.50 3.00 2.00 2.00 0.50 3.33 International feed No. 6–26–335 6–04–152 6–02–756 5–01–625 .............................. 6–01–069 4–04–695 6–03–755 8–03–123 6–02–431 .............................. 1 Content of vitamin and trace mineral premixes may be varied. However, they should be comparable to those used for other free-choice feeds. Formulation modifications require FDA approval prior to marketing. Selenium must comply with 21 CFR 573.920. Ethylenediamine dihydroiodide (EDDI) should comply with FDA Compliance Policy Guides Sec. 651.100 (CPG 7125.18). (ii) Amount. 6,000 grams per ton. (iii) Indications for use. Beef and nonlactating dairy cattle: As an aid in the control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline. (iv) Limitations. Feed continuously on a free-choice basis at a rate of 0.5 to 2.0 mg chlortetracycline per pound of body weight per day. (v) Sponsor. See No. 054771 in § 510.600(c) of this chapter. 9. In § 558.140, redesignate paragraph (d) as paragraph (e) and add new paragraph (d) to read as follows: ■ § 558.140 Chlortetracycline and sulfamethazine. * * * * * (d) Special considerations—(1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian. See § 558.6 for additional requirements. (2) The expiration date of VFDs for chlortetracycline and sulfamethazine medicated feeds must not exceed 6 months from the date of issuance. VFDs for chlortetracycline and sulfamethazine shall not be refilled. * * * * * § 558.145 [Removed] § 558.175 Clopidol. * * * * * (c) Related tolerances. See § 556.160 of this chapter. * * * * * (e) Clopidol may also be used in combination with: (1) [Reserved] (2) [Reserved] (3) Chlortetracycline as in § 558.128. (4) Lincomycin as in § 558.325. ■ 12. In § 558.195, remove and reserve paragraphs (e)(1)(iv) through (vi), (e)(2)(ii), (e)(2)(iv), and (e)(2)(vii); and add paragraph (e)(4) to read as follows: § 558.195 13. In § 558.198, remove and reserve paragraphs (d)(1)(iv) and (v); and add paragraph (d)(3) to read as follows: ■ 10. Remove § 558.145. ■ 11. In § 558.175, in paragraph (b), remove ‘‘Approvals’’ and in its place add ‘‘Sponsor’’; add paragraph (c); remove and reserve paragraphs (d)(5) and (6); and add paragraph (e) to read as follows: ■ Decoquinate. * * * * * (e) * * * (4) Decoquinate may also be used in combination with: (i) [Reserved] (ii) [Reserved] (iii) Chlortetracycline as in § 558.128. (iv) Lincomycin as in § 558.325. § 558.198 Diclazuril. * * * * * (d) * * * (3) Diclazuril may also be used in combination with virginiamycin as in § 558.635. ■ 14. In § 558.248, revise paragraph (a); redesignate paragraph (d) as paragraph (e); add new paragraph (d); and revise redesignated paragraph (e) to read as follows: § 558.248 Erythromycin. (a) Specifications. Type A medicated articles containing 92.5 grams per pound erythromycin (as the thiocyanate salt). * * * * * (d) Special considerations.—(1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian. See § 558.6 for additional requirements. (2) The expiration date of VFDs for erythromycin medicated feeds must not exceed 6 months from the date of issuance. VFDs for erythromycin shall not be refilled. (e) Conditions of use—(1) Chickens— Combination in grams/ton Indications for use Limitations (i) 92.5 .................... asabaliauskas on DSK3SPTVN1PROD with RULES Erythromycin in grams/ton ................................ (ii) 92.5 ................... ................................ (iii) 185 ................... ................................ Chickens: As an aid in the prevention of chronic respiratory disease during periods of stress. Chickens: As an aid in the prevention of infectious coryza. Chickens: As an aid in the prevention and reduction of lesions and in lowering severity of chronic respiratory disease (CRD). Feed for 2 days before stress and 3 to 6 days after stress. Withdraw 24 hours before slaughter. Feed for 7 to 14 days. Withdraw 24 hours before slaughter. Feed for 5 to 8 days. Withdraw 48 hours before slaughter. Do not use in birds producing eggs for food. VerDate Sep<11>2014 19:06 Dec 23, 2016 Jkt 241001 PO 00000 Frm 00096 Fmt 4700 Sfmt 4700 E:\FR\FM\27DER1.SGM 27DER1 Sponsor 061623 061623 061623 Federal Register / Vol. 81, No. 248 / Tuesday, December 27, 2016 / Rules and Regulations 95005 (2) Turkeys— Erythromycin thiocyanate in grams/ton Combination in grams/ton Indications for use Limitations (i) 92.5 .................... ................................ Feed for 2 days before stress and 3 to 6 days after stress. 061623 (ii) 185 .................... ................................ Turkeys: As an aid in the prevention of chronic respiratory disease during periods of stress. Turkeys: As an aid in the prevention and reduction of lesions and in lowering severity of chronic respiratory disease (CRD). Feed for 5 to 8 days. Do not use in birds producing eggs for food. 061623 15. In § 558.258, remove and reserve paragraphs (e)(2)(ii) through (v); and add paragraph (e)(6) to read as follows: ■ § 558.258 Fenbendazole. * * * * * (e) * * * (6) Fenbendazole may also be used in combination with: (i) [Reserved] (ii) Lincomycin as in § 558.325. ■ 16. In § 558.265, remove and reserve paragraphs (d)(1)(iii), (d)(1)(iv), and (d)(1)(vii); and add paragraph (d)(4) to read as follows: § 558.265 * * Halofuginone. * * * (d) * * * (4) Halofuginone may also be used in combination with: (i) [Reserved] (ii) Lincomycin as in § 558.325. (iii) Virginiamycin as in § 558.635. 17. Revise § 558.274 to read as follows: ■ § 558.274 Hygromycin B. (a) Specifications. Type A medicated articles containing 2.4 or 8 grams hygromycin B per pound (g/lb). (b) Sponsor. See No. 058198 in § 510.600(c) of this chapter for as follows: Sponsor (c) Related tolerances. See § 556.330 of this chapter. (d) Special considerations—(1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian. See § 558.6 for additional requirements. (2) The expiration date of VFDs for hygromycin B medicated feeds must not exceed 6 months from the date of issuance. VFDs for hygromycin B shall not be refilled. (e) Conditions of use. It is used in feed as follows: (1) Chickens— Hygromycin B grams/ton Combination in grams/ton Indications for use Limitations (i) 8 to 12 ............... ................................ Chickens: For control of infections of large roundworms (Ascaris galli), cecal worms (Heterakis gallinae), and capillary worms (Capillaria obsignata). Use in complete feed. Withdraw 3 days before slaughter. Hygromycin B grams/ton Combination in grams/ton Indications for use Limitations (i) 12 ....................... ................................ Swine: For control of infections of large roundworms (A. suis), nodular worms (O. dentatum), and whipworms (Trichuris suis). In market hogs, use in complete feed for 8 weeks during the growing period. Withdraw 15 days before slaughter. Sponsor 058198 (ii) [Reserved] (2) Swine— Sponsor 058198 (ii) [Reserved] § 558.305 18. In § 558.300, remove and reserve paragraphs (e)(4) through (7); and add paragraph (f) to read as follows: ■ § 558.300 Ivermectin. asabaliauskas on DSK3SPTVN1PROD with RULES * * * * * (f) Ivermectin may also be used in combination with: (1) [Reserved] (2) Lincomycin as in § 558.325. ■ 19. In § 558.305, remove paragraphs (e)(2), (e)(3), (e)(5), and (e)(6); redesignate paragraph (e)(4) as new paragraph (e)(2); and add paragraph (f) to read as follows: VerDate Sep<11>2014 19:06 Dec 23, 2016 Jkt 241001 Laidlomycin. * * * * * (f) Laidlomycin may also be used in combination with chlortetracycline as in § 558.128. ■ 20. In § 558.311, in paragraph (e)(1)(i), in the row entry for ‘‘Bambermycins 1 to 2’’, in the ‘‘Lasalocid sodium in grams per ton’’ column, add ‘‘(ii) 68 (0.0075 pct) to 113 (0.0125 pct).’’; in paragraphs (e)(1)(vi) and (vii), remove the row entries for ‘‘Oxytetracycline 7.5’’; in paragraph (e)(1)(xv), remove the row entry for ‘‘Virginiamycin 10 to 20’’; remove and reserve paragraphs PO 00000 Frm 00097 Fmt 4700 Sfmt 4700 (e)(1)(iii), (e)(1)(v), and (e)(1)(xx) through (e)(1)(xxviii); redesignate paragraph (e)(5)(i) as paragraph (e)(5)(ii); and add new paragraphs (e)(5)(i) and (e)(5)(iii) to read as follows: § 558.311 Lasalocid. * * * * * (e) * * * (5) * * * (i) Chlortetracycline as in § 558.128. * * * * * (iii) Virginiamycin as in § 558.635. ■ 21. Revise § 558.325 to read as follows: E:\FR\FM\27DER1.SGM 27DER1 95006 § 558.325 Federal Register / Vol. 81, No. 248 / Tuesday, December 27, 2016 / Rules and Regulations Lincomycin. (a) Specifications. Type A medicated articles containing 20 or 50 grams of lincomycin (as lincomycin hydrochloride) per pound. (b) Sponsors. See No. 054771 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.360 of this chapter. (d) Special considerations—(1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian. See § 558.6 for additional requirements. (2) The expiration date of VFDs for chlortetracycline and sulfamethazine medicated feeds must not exceed 6 months from the date of issuance. VFDs for chlortetracycline and sulfamethazine shall not be refilled. (3) Labeling of Type A medicated articles and Type B and Type C medicated feeds containing lincomycin shall bear the following: (i) ‘‘CAUTION: Do not allow rabbits, hamsters, guinea pigs, horses, or ruminants access to feeds containing lincomycin. Ingestion by these species may result in severe gastrointestinal effects.’’ (4) Labeling of medicated feeds containing lincomycin intended for use in swine shall bear the following: (i) ‘‘CAUTION: Occasionally, swine fed lincomycin may within the first 2 days after the onset of treatment develop diarrhea and/or swelling of the anus. On rare occasions, some pigs may show reddening of the skin and irritable behavior. These conditions have been self-correcting within 5 to 8 days without discontinuing the lincomycin treatment.’’ (ii) ‘‘CAUTION: The effects of lincomycin on swine reproductive performance, pregnancy, and lactation have not been determined.’’ (e) Conditions of use—(1) Chickens— Lincomycin grams/ton Combination in grams/ton Indications for use Limitations (i) 2 ......................... ................................ Broilers: For the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to lincomycin. Feed as the sole ration. Not for use in layers, breeders, or turkeys. Lincomycin grams/ton Combination in grams/ton Indications for use Limitations (i) 40 ....................... ................................ For control of swine dysentery and the control of porcine proliferative enteropathies (ileitis) caused by Lawsonia intracellularis. (ii) 40 ...................... Fenbendazole, 10 to 80. For control of swine dysentery in animals on premises with a history of swine dysentery, but where symptoms have not yet occurred; and for the removal of: Adult stage lungworms (Metastrongylus apri and M. pudendotectus); adult and larvae (L3, 4 stages—liver, lung, intestinal forms) large roundworms (Ascaris suum); adult stage nodular worms (Oesophagostomum dentatum, O. quadrispinulatum); adult stage small stomach worms (Hyostrongylus rubidus); adult and larvae (L2, 3, 4 stages—intestinal mucosal forms) whipworms (Trichuris suis); adult and larvae kidney worms (Stephanurus dentatus). Feed as sole ration. For use in swine on premises with a history of swine dysentery but where symptoms have not yet occurred, or following use of lincomycin at 100 grams (g)/ton for the treatment of swine dysentery and the control of porcine proliferative enteropathies (ileitis). Feed as sole ration to provide a total dose of 9 mg fenbendazole/kg of body weight within 3 to 12 days. Do not feed to swine that weigh more than 250 pounds. Lincomycin as provided by No. 054771; fenbendazole as provided by No. 000061 in § 510.600(c) of this chapter. Sponsors 054771 (ii) [Reserved] asabaliauskas on DSK3SPTVN1PROD with RULES (2) Swine— VerDate Sep<11>2014 19:06 Dec 23, 2016 Jkt 241001 PO 00000 Frm 00098 Fmt 4700 Sfmt 4700 E:\FR\FM\27DER1.SGM 27DER1 Sponsors 054771 000061 Federal Register / Vol. 81, No. 248 / Tuesday, December 27, 2016 / Rules and Regulations 95007 Combination in grams/ton Indications for use Limitations (iii) 40 ..................... Ivermectin, 1.8 ....... 050604 Pyrantel, 96 ........... Feed as the sole ration. Not to be fed to swine that weigh more than 250 pounds. Withdraw 6 days prior to slaughter. Lincomycin as provided by No. 054771; pyrantel as provided by No. 066104 in § 510.600(c) of this chapter. 066104 (v) 40 ...................... Pyrantel, 96 ........... Weaned, growing and finishing swine: For control of swine dysentery on premises with a history of swine dysentery, but where symptoms have not yet occurred; and for treatment and control of gastrointestinal roundworms (Ascaris suum, adults and fourthstage larvae; Ascarops strongylina, adults; Hyostrongylus rubidus, adults and fourth-stage larvae; Oesophagostomum spp., adults and fourth-stage larvae); kidney worms (Stephanurus dentatus, adults and fourth-stage larvae); lungworms (Metastrongylus spp., adults); lice (Haematopinus suis); and mange mites (Sarcoptes scabiei var. suis). For control of swine dysentery on premises with a history of swine dysentery, but where symptoms have not yet occurred; as an aid in the prevention of migration and establishment of large roundworm (Ascaris suum) infections; and as an aid in the prevention of establishment of nodular worm (Oesophagostomum spp.) infections. For the treatment and/or control of swine dysentery; for removal and control of large roundworm (Ascaris suum) infections. Feed as the only feed for 7 consecutive days to provide 0.1 mg ivermectin/kg of body weight per day. A separate feed containing 40 g/ton lincomycin may be continued to complete the lincomycin treatment. Not to be fed to swine that weigh more than 250 lbs. Withdraw 5 days before slaughter. Lincomycin as provided by No. 054771; ivermectin as provided by No. 050604 in § 510.600(c) of this chapter. (iv) 40 ..................... Pyrantel, 96 ........... For the treatment and/or control of swine dysentery; as an aid in the prevention of migration and establishment of large roundworm (Ascaris suum) infections; and as an aid in the prevention of establishment of nodular worm (Oesophagostomum spp.) infections. (vii) 100 .................. ................................ (viii) 100 ................. Fenbendazole, 10 to 80. For treatment of swine dysentery and the control of porcine proliferative enteropathies (ileitis) caused by Lawsonia intracellularis. For the treatment of swine dysentery; and for the removal of: Adult stage lungworms (Metastrongylus apri and M. pudendotectus); adult and larvae (L3, 4 stages—liver, lung, intestinal forms) large roundworms (Ascaris suum); adult stage nodular worms (Oesophagostomum dentatum, O. quadrispinulatum); adult stage small stomach worms (Hyostrongylus rubidus); adult and larvae (L2, 3, 4 stages—intestinal mucosal forms) whipworms (Trichuris suis); adult and larvae kidney worms (Stephanurus dentatus). Feed for 3 days as the sole ration. Not to be fed to swine that weigh more than 250 pounds. Withdraw 24 hours prior to slaughter. Lincomycin as provided by No. 054771; pyrantel as provided by No. 066104 in § 510.600(c) of this chapter. For treatment of swine dysentery, feed 100 grams of lincomycin and 96 grams of pyrantel tartrate per ton of complete feed for 3 weeks or until clinical signs of the disease disappear, following with 40 grams of lincomycin and 96 grams of pyrantel tartrate per ton of complete feed as the sole ration. Not to be fed to swine that weigh more than 250 pounds. Withdraw 6 days prior to slaughter. Lincomycin as provided by No. 054771; pyrantel as provided by No. 066104 in § 510.600(c) of this chapter. Feed as the sole ration for 3 weeks or until clinical signs of the disease disappear. 066104 (vi) 40 or 100 ......... asabaliauskas on DSK3SPTVN1PROD with RULES Lincomycin grams/ton VerDate Sep<11>2014 19:06 Dec 23, 2016 Jkt 241001 PO 00000 Frm 00099 Fmt 4700 Sfmt 4700 Feed as sole ration to provide a total dose of 9 mg fenbendazole/kg of body weight within 3 to 12 days. Do not feed to swine that weigh more than 250 pounds. Do not use within 6 days of slaughter. Lincomycin as provided by No. 054771; fenbendazole as provided by No. 000061 in § 510.600(c) of this chapter. E:\FR\FM\27DER1.SGM 27DER1 Sponsors 066104 054771 000061 95008 Federal Register / Vol. 81, No. 248 / Tuesday, December 27, 2016 / Rules and Regulations Combination in grams/ton Indications for use Limitations (ix) 100 ................... Ivermectin, 1.8 ....... 050604 Pyrantel, 96 ........... Weaned, growing and finishing swine: For the treatment of swine dysentery; and for treatment and control of gastrointestinal roundworms (Ascaris suum, adults and fourth-stage larvae; Ascarops strongylina, adults; Hyostrongylus rubidus, adults and fourth-stage larvae; Oesophagostomum spp., adults and fourth-stage larvae); kidneyworms (Stephanurus dentatus, adults and fourth-stage larvae); lungworms (Metastrongylus spp., adults); lice (Haematopinus suis); and mange mites (Sarcoptes scabiei var. suis). For the treatment of swine dysentery; as an aid in the prevention of migration and establishment of large roundworm (Ascaris suum) infections; and as an aid in the prevention of establishment of nodular worm (Oesophagostomum spp.) infections. Feed as the only feed for 7 consecutive days to provide 0.1 mg ivermectin/kg of body weight per day. A separate feed containing 100 g/ton lincomycin may be continued to complete the lincomycin treatment. Not to be fed to swine that weigh more than 250 lbs. Withdraw 6 days before slaughter. Lincomycin as provided by No. 054771; ivermectin as provided by No. 050604 in § 510.600(c) of this chapter. (x) 100 .................... Pyrantel, 96 ........... For the treatment and/or control of swine dysentery; for removal and control of large roundworm (Ascaris suum) infections. (xii) 100 .................. Pyrantel, 800 ......... For the treatment and/or control of swine dysentery; for removal and control of large roundworm (Ascaris suum) and nodular worm (Oesophagostomum spp.) infections. (xiii) 200 ................. ................................ (xiv) 200 ................. Fenbendazole, 10 to 80. For reduction in the severity of swine mycoplasmal pneumonia caused by Mycoplasma hyopneumoniae. For reduction in the severity of swine mycoplasmal pneumonia caused by Mycoplasma hyopneumoniae; and for the removal of: Adult stage lungworms (Metastrongylus apri and M. pudendotectus); adult and larvae (L3, 4 stages—liver, lung, intestinal forms) large roundworms (Ascaris suum); adult stage nodular worms (Oesophagostomum dentatum, O. quadrispinulatum); adult stage small stomach worms (Hyostrongylus rubidus); adult and larvae (L2, 3, 4 stages—intestinal mucosal forms) whipworms (Trichuris suis); adult and larvae kidney worms (Stephanurus dentatus). Feed as the sole ration for 3 weeks or until clinical signs of the disease disappear. Not to be fed to swine that weigh more than 250 pounds. Withdraw 6 days prior to slaughter. Lincomycin as provided by No. 054771; pyrantel as provided by No. 066104 in § 510.600(c) of this chapter. Feed for 3 days as the sole ration. Not to be fed to swine that weigh more than 250 pounds. Withdraw 24 hours prior to slaughter. Lincomycin as provided by No. 054771; pyrantel as provided by No. 066104 in § 510.600(c) of this chapter. Feed as a single therapeutic treatment. Not to be fed to swine that weigh more than 250 pounds. Withdraw 24 hours prior to slaughter. Lincomycin as provided by No. 054771; pyrantel as provided by No. 066104 in § 510.600(c) of this chapter. Feed as sole ration for 21 days ............. 066104 (xi) 100 ................... asabaliauskas on DSK3SPTVN1PROD with RULES Lincomycin grams/ton VerDate Sep<11>2014 19:06 Dec 23, 2016 Jkt 241001 PO 00000 Frm 00100 Fmt 4700 Sfmt 4700 Feed as sole ration to provide a total dose of 9 mg fenbendazole/kg of body weight within 3 to 12 days. Do not feed to swine that weigh more than 250 pounds. Do not use within 6 days of slaughter. Lincomycin as provided by No. 054771; fenbendazole as provided by No. 000061 in § 510.600(c) of this chapter. E:\FR\FM\27DER1.SGM 27DER1 Sponsors 066104 066104 054771 000061 95009 Federal Register / Vol. 81, No. 248 / Tuesday, December 27, 2016 / Rules and Regulations Lincomycin grams/ton Combination in grams/ton Indications for use Limitations (xv) 200 .................. Ivermectin, 1.8 ....... Feed as the only feed for 7 consecutive days to provide 0.1 mg ivermectin/kg of body weight per day. A separate feed containing 200 g/ton lincomycin may be continued for an additional 14 days to complete the lincomycin treatment. Not to be fed to swine that weigh more than 250 lbs. Withdraw 6 days before slaughter. Lincomycin as provided by No. 054771; ivermectin as provided by No. 050604 in § 510.600(c) of this chapter. 050604 (xvi) 200 ................. Pyrantel, 96 ........... For reduction in the severity of swine mycoplasmal pneumonia caused by Mycoplasma hyopneumoniae; and for treatment and control of gastrointestinal roundworms (Ascaris suum, adults and fourth-stage larvae; Ascarops strongylina, adults; Hyostrongylus rubidus, adults and fourth-stage larvae; Oesophagostomum spp., adults and fourth-stage larvae); kidneyworms (Stephanurus dentatus, adults and fourth-stage larvae); lungworms (Metastrongylus spp., adults); lice (Haematopinus suis); and mange mites (Sarcoptes scabiei var. suis). For reduction in the severity of swine mycoplasmal pneumonia caused by Mycoplasma hyopneumoniae; and as an aid in the prevention of migration and establishment of large roundworm (Ascaris suum) infections; aid in the prevention of establishment of nodular worm (Oesophagostomum spp.) infections. Feed as the sole ration for 21 days. Not for use in swine that weigh more than 250 pounds. Withdraw 6 days before slaughter. Lincomycin as provided by No. 054771; pyrantel as provided by No. 066104 in § 510.600(c) of this chapter. 054771 22. In § 558.342, remove and reserve paragraphs (e)(1)(iii), (e)(1)(iv), (e)(1)(viii), (e)(1)(ix), and (e)(1)(xi); and revise paragraph (e)(2) to read as follows: ■ § 558.342 Melengestrol. * * * * * (e) * * * (2) Melengestrol may also be used in combination with: (i) Ractopamine as in § 558.500. (ii) Tylosin as in § 558.625. (iii) Zilpaterol as in § 558.665. ■ 23. In § 558.355, revise paragraphs (a) and (b); remove and reserve paragraphs (f)(1)(viii), (f)(1)(ix), (f)(1)(xiii), (f)(1)(xiv), (f)(1)(xxi), (f)(1)(xxii), (f)(1)(xxxi), (f)(2)(iv), (f)(3)(ii), and (f)(3)(xii); and revise paragraph (f)(8) to read as follows: asabaliauskas on DSK3SPTVN1PROD with RULES § 558.355 Monensin. (a) Specifications. Type A medicated articles containing 45, 60, 90.7, or 110 grams monensin, USP, per pound. (b) Approvals. See sponsor numbers in § 510.600(c) of this chapter for conditions of use as in paragraph (f) of this section: (1) No. 058198 for use as in paragraph (f) of this section. (2) No. 054771 for use as in paragraphs (f)(1)(xxiv) and (xxv) of this section. (3) No. 058198 for use as in paragraphs (f)(1)(i), (iii), (iv), and (v) of this section. * * * * * (f) * * * VerDate Sep<11>2014 19:06 Dec 23, 2016 Jkt 241001 (8) Monensin may also be used in combination with: (i) Chlortetracycline as in § 558.128. (ii) Decoquinate as in § 558.195. (iii) Lincomycin as in § 558.325. (iv) Melengestrol acetate as in § 558.342. (v) Oxytetracycline as in § 558.128. (vi) Ractopamine alone or in combination as in § 558.500. (vii) Tilmicosin as in § 558.618. (viii) Tylosin as in § 558.625. (ix) Virginiamycin as in § 558.635. (x) Zilpaterol alone or in combination as in § 558.665. ■ 24. In § 558.364, redesignate paragraph (d) as paragraph (e) and revise paragraphs (a) through (d) to read as follows: § 558.364 Neomycin sulfate. (a) Specifications. Type A medicated article containing 325 grams neomycin sulfate per pound. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.430 of this chapter. (d) Special considerations—(1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian. See § 558.6 for additional requirements. (2) The expiration date of VFDs for neomycin medicated feeds must not exceed 6 months from the date of issuance. VFDs for neomycin shall not be refilled. * * * * * PO 00000 Frm 00101 Fmt 4700 Sfmt 4700 Sponsors 25. In § 558.366, in the table in paragraph (d), remove the row entries under ‘‘Nicarbazin in grams per ton’’ ‘‘27 to 45’’ for ‘‘Narasin 27 to 45 and Lincomycin 2 to 4’’; and under ‘‘Nicarbazin in grams per ton’’ ‘‘113.5 (0.0125 pct)’’ for ‘‘Lincomycin 2 (0.00044 pct)’’; and add paragraph (e) to read as follows: ■ § 558.366 Nicarbazin. * * * * * (e) * * * (6) Nicarbazin may also be used in combination with: (i) [Reserved] (ii) Lincomycin as in § 558.325. § 558.435 [Removed] 26. Remove § 556.435. ■ 27. Revise § 558.450 to read as follows: ■ § 558.450 Oxytetracycline. (a) Specifications. Each pound of Type A medicated article contains: (1) Oxytetracycline (from oxytetracycline quaternary salt) equivalent to 50 or 100 grams oxytetracycline hydrochloride; or oxytetracycline (from oxytetracycline dihydrate base) equivalent to 10, 30, 50, 100, or 200 grams oxytetracycline hydrochloride. (2) Oxytetracycline (from oxytetracycline dihydrate base) equivalent to 50, 100, or 200 grams oxytetracycline hydrochloride; or 100 grams oxytetracycline hydrochloride. (b) Sponsors. See sponsors in § 510.600(c) of this chapter as follows: E:\FR\FM\27DER1.SGM 27DER1 95010 Federal Register / Vol. 81, No. 248 / Tuesday, December 27, 2016 / Rules and Regulations (1) No. 066104: Type A medicated articles as in paragraph (a)(1) of this section. (2) No. 069254: Type A medicated articles as in paragraph (a)(2) of this section. (c) Related tolerances. See § 556.500 of this chapter. (d) Special considerations—(1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian. See § 558.6 for additional requirements. (2) The expiration date of VFDs for oxytetracycline medicated feeds must not exceed 6 months from the date of issuance. VFDs for oxytetracycline shall not be refilled. (3) In accordance with § 558.5, labeling shall bear the statement: ‘‘For use in dry animal feed only. Not for use in liquid feed supplements.’’ (e) Conditions of use—(1) Chickens— Combination in grams/ton Indications for use Limitations (i) 100 to 200 g/ton ................................ Chickens: For control of infectious synovitis caused by Mycoplasma synoviae and control of fowl cholera caused by Pasteurella multocida susceptible to oxytetracycline. (ii) 200 g/ton ........... Monensin, 90 to 110. Broiler chickens: As an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima; and for the control of complicated chronic respiratory disease (CRD or air sac infection) caused by Mycoplasma gallisepticum and Escherichia coli. (iii) 400 g/ton .......... ................................ Chickens: For control of chronic respiratory disease (CRD) and air sac infection caused by Mycoplasma gallisepticum and Escherichia coli susceptible to oxytetracycline. (iv) 400 g/ton .......... Robenidine, 30 ...... Broiler chickens: As an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima; and for the control of chronic respiratory disease (CRD) and air sac infection caused by Mycoplasma gallisepticum and Escherichia coli susceptible to oxytetracycline. (v) 500 g/ton ........... ................................ Chickens: For reduction of mortality due to air sacculitis (air sac infection) caused by E. coli susceptible to oxytetracycline. (vi) 500 g/ton .......... asabaliauskas on DSK3SPTVN1PROD with RULES Oxytetracycline amount Monensin, 90 to 100. Broiler chickens: As an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima; and as an aid in the reduction of mortality due to airsacculitis (air sac infection) caused by Escherichia coli sensitive to oxytetracycline. Feed continuously for 7 to 14 days. Do not feed to chickens producing eggs for human consumption. Do not use in feed containing less than 0.55% dietary calcium. Use in such low calcium feeds may result in violative residues. Zero-day withdrawal period. Feed continuously as the sole ration. Do not feed to laying chickens. Do not feed to chickens over 16 weeks of age. Do not use in feed containing less than 0.55% dietary calcium. Use in such low calcium feeds may result in violative residues. Withdraw 72 hours before slaughter. See § 558.355(d) of this chapter Oxytetracycline as provided by No. 066104; monensin as provided by No. 058198 in § 510.600(c) of this chapter. Feed continuously for 7 to 14 days. Do not feed to chickens producing eggs for human consumption. Do not use in feed containing less than 0.55% dietary calcium. Use in such low calcium feeds may result in violative residues. Zero-day withdrawal period. Feed continuously for 7 to 14 days. Do not feed to chickens producing eggs for human consumption. Do not use in feed containing less than 0.55% dietary calcium. Use in such low calcium feeds may result in violative residues. Withdraw 5 days before slaughter. Oxytetracycline as provided by No. 066104; robenidine as provided by No. 054771 in § 510.600(c) of this chapter. Feed continuously for 5 days. Do not feed to chickens producing eggs for human consumption. Do not use in feed containing less than 0.55% dietary calcium. Use in such low calcium feeds may result in violative residues. Withdraw 24 hours before slaughter. Feed for 5 days as the sole ration. Treat at first clinical signs of the disease. Do not feed to laying chickens. Do not feed to chickens over 16 weeks of age. Do not use in feed containing less than 0.55% dietary calcium. Use in such low calcium feeds may result in violative residues. Withdraw 72 hours before slaughter. See § 558.355(d) of this chapter. Oxytetracycline as provided by No. 066104; monensin as provided by No. 058198 in § 510.600(c) of this chapter. VerDate Sep<11>2014 19:06 Dec 23, 2016 Jkt 241001 PO 00000 Frm 00102 Fmt 4700 Sfmt 4700 E:\FR\FM\27DER1.SGM 27DER1 Sponsor 066104 069254 066104 066104 069254 066104 066104 069254 066104 Federal Register / Vol. 81, No. 248 / Tuesday, December 27, 2016 / Rules and Regulations Oxytetracycline amount (vii) 500 g/ton ......... Combination in grams/ton Salinomycin, 40 to 60. Indications for use Limitations Chickens: For the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima; and as an aid in the reduction of mortality due to air-sacculitis (air sac infection) caused by E. coli sensitive to oxytetracycline. Feed for 5 days as the sole ration. Treat at first clinical signs of the disease. Do not feed to laying chickens. Do not use in feed containing less than 0.55% dietary calcium. Use in such low calcium feeds may result in violative residues. Withdraw 24 hours before slaughter. Oxytetracycline as provided by No. 066104; salinomycin as provided by No. 016592 in § 510.600(c) of this chapter. 95011 Sponsor 066104 016592 (2) Turkeys— Oxytetracycline amount Indications for use Limitations (i) 100 g/ton ............ Turkeys: For control of hexamitiasis caused by Hexamita meleagridis susceptible to oxytetracycline. Turkeys: For control of infectious synovitis caused by M. synoviae susceptible to oxytetracycline. Feed continuously for 7 to 14 days. Do not feed to turkeys producing eggs for human consumption. Zero-day withdrawal period. Feed continuously for 7 to 14 days. Do not feed to turkeys producing eggs for human consumption. For No. 066104, withdraw 5 days before slaughter. For No. 069254, zero-day withdrawal period. Feed continuously for 7 to 14 days. Do not feed to turkeys producing eggs for human consumption. For No. 066104, withdraw 5 days before slaughter. For No. 069254, zero-day withdrawal period. (ii) 200 g/ton ........... (iii) 25 mg/lb of body weight daily. Turkeys: For control of complicating bacterial organisms associated with bluecomb (transmissible enteritis; coronaviral enteritis) susceptible to oxytetracycline. Sponsor 066104 069254 066104 069254 066104 069254 (3) Swine— Oxytetracycline amount Combination in grams/ton Indications for use Limitations (i) 10 mg/lb of body weight daily. ................................ 1. Swine: For treatment of bacterial enteritis caused by Escherichia coli and Salmonella choleraesuis susceptible to oxytetracycline and treatment of bacterial pneumonia caused by Pasteurella multocida susceptible to oxytetracycline. 2. Breeding swine: For control and treatment of leptospirosis (reducing the incidence of abortion and shedding of leptospirae) caused by Leptospira pomona susceptible to oxytetracycline. Swine: For treatment of bacterial enteritis caused by E. coli and Salmonella choleraesuis susceptible to oxytetracycline and treatment of bacterial pneumonia caused by Pasteurella multocida susceptible to oxytetracycline; and for increased rate of weight gain and improved feed efficiency. Feed continuously for 7 to 14 days ....... 066104 069254 Feed continuously for 14 days .............. 066104 069254 Feed continuously as the sole ration for 7 to 14 days. Not for use in pregnant swine or swine intended for breeding purposes. Do not mix in feeds containing bentonite. Do not feed to swine within 42 days of slaughter. Oxytetracycline and carbadox as provided by No. 066104 in § 510.600(c) of this chapter. 066104 (ii) 10 mg/lb of body weight daily. Carbadox, 10 to 25 asabaliauskas on DSK3SPTVN1PROD with RULES (4) Cattle— VerDate Sep<11>2014 19:06 Dec 23, 2016 Jkt 241001 PO 00000 Frm 00103 Fmt 4700 Sfmt 4700 E:\FR\FM\27DER1.SGM 27DER1 Sponsor 95012 Federal Register / Vol. 81, No. 248 / Tuesday, December 27, 2016 / Rules and Regulations Oxytetracycline amount Combination in grams/ton Indications for use Limitations (i) 10 mg/lb of body weight daily. ................................ 1. Calves and beef and nonlactating dairy cattle: For treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia (shipping fever complex) caused by Pasteurella multocida susceptible to oxytetracycline. 2. Calves: For treatment of bacterial enteritis caused by E. coli susceptible to oxytetracycline. Feed continuously for 7 to 14 days. For No. 069254, withdraw 5 days before slaughter. For No. 066104, zero-day withdrawal period. 066104 069254 Feed continuously for 7 to 14 days in milk replacer or starter feed. This product 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. For No. 069254, withdraw 5 days before slaughter. For No. 066104, zero-day withdrawal period. Feed continuously .................................. 066104 069254 (ii) 75 mg/head/day ................................ (iii) 0.5 to 2.0 g/ head/day. ................................ Growing cattle (over 400 lb): For reduction of incidence of liver abscesses. Cattle: For prevention and treatment of the early stages of shipping fever complex. Feed 3 to 5 days before and after arrival in feedlots. Sponsor 066104 069254 066104 069254 (5) Minor species— Oxytetracycline amount (i) 10 mg/lb of body weight daily. (ii) 200 mg/colony .......... (iii) 250 mg/kilogram of fish/day (11.35 g/100 lb of fish/day). (iv) 2.5 to 3.75 g/100 lb of fish/day. (v) 3.75 g/100 lb of fish/ day. Indications for use Limitations Sheep: For treatment of bacterial enteritis caused by E. coli and bacterial pneumonia caused by P. multocida susceptible to oxytetracycline. Honey bees: For control of American foulbrood caused by Paenibacillus larvae and European foulbrood caused by Streptococcus pluton susceptible to oxytetracycline. Pacific salmon: For marking of skeletal tissue .... Feed continuously for 7 to 14 days; withdraw 5 days before slaughter. 066104 069254 Remove at least 6 weeks prior to main honey flow. 066104 069254 For salmon not over 30 g body weight; administer as sole ration for 4 consecutive days; fish not to be liberated for at least 7 days following the last administration of medicated feed. Administer in mixed ration for 10 days; do not liberate fish or slaughter fish for food for 21 days following the last administration of medicated feed. 066104 1. Salmonids: For control of ulcer disease caused by Haemophilus piscium, furunculosis caused by Aeromonas salmonicida, bacterial hemorrhagic septicemia caused by A. liquefaciens, and pseudomonas disease. 2. Catfish: For control of bacterial hemorrhagic septicemia caused by A. liquefaciens and pseudomonas disease. 1. Freshwater-reared salmonids: For control of mortality due to coldwater disease associated with Flavobacterium psychrophilum. 2. Freshwater-reared Oncorhynchus mykiss: For control of mortality due to columnaris disease associated with Flavobacterium columnare. asabaliauskas on DSK3SPTVN1PROD with RULES (vi) 1 g/lb of medicated feed. Lobsters: For control of gaffkemia caused by Aerococcus viridans. 28. In § 558.455, revise paragraph (d); remove and reserve paragraphs (e)(1)(i), (e)(2)(i), (e)(3)(i), (e)(4)(i), (e)(4)(ii), and (e)(4)(iv); and in paragraph (e)(4)(v), remove ‘‘increased rate of weight gain; ■ VerDate Sep<11>2014 19:06 Dec 23, 2016 Jkt 241001 Administer in mixed ration for 10 days; do not liberate fish or slaughter fish for food for 21 days following the last administration of medicated feed; do not administer when water temperature is below 16.7 °C (62 °F). Administer in mixed ration for 10 days; do not liberate fish or slaughter fish for food for 21 days following the last administration of medicated feed. Administer in mixed ration for 10 days; do not liberate fish or slaughter fish for food for 21 days following the last administration of medicated feed. Administer as sole ration for 5 consecutive days; withdraw medicated feed 30 days before harvesting lobsters. improved feed efficiency, and’’ to read as follows: § 558.455 Oxytetracycline and neomycin. * * * * * (d) Special considerations—(1) Federal law restricts medicated feed PO 00000 Frm 00104 Fmt 4700 Sfmt 4700 Sponsor 066104 066104 066104 066104 066104 containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian. See § 558.6 for additional requirements. (2) The expiration date of VFDs for oxytetracycline and neomycin E:\FR\FM\27DER1.SGM 27DER1 Federal Register / Vol. 81, No. 248 / Tuesday, December 27, 2016 / Rules and Regulations medicated feeds must not exceed 6 months from the date of issuance. VFDs for oxytetracycline and neomycin shall not be refilled. (3) Cattle feeds shall bear the following warning statement: ‘‘Use of more than one product containing neomycin or failure to follow withdrawal times may result in illegal drug residues.’’ * * * * * § 558.460 (e) Robenidine may also be used in combination with: (1) Chlortetracycline as in § 558.128. (2) Lincomycin as in § 558.325. (3) Oxytetracycline as in § 558.450. ■ 33. In § 558.550, remove and reserve paragraphs (d)(1)(x), (d)(1)(xi), (d)(1)(xiii), and (d)(1)(xvi); and revise paragraph (d)(4) to read as follows: § 558.550 [Removed] 29. Remove § 558.460. ■ 30. In § 558.485, remove paragraphs (e)(1)(v) through (xii); and add paragraph (e)(3) to read as follows: ■ § 558.485 Pyrantel. * * * * * (e) * * * (3) Pyrantel may also be used in combination with: (i) Lincomycin as in § 558.325. (ii) Tylosin as in § 558.325. ■ 31. In § 558.500, remove and reserve paragraphs (e)(1)(ii), (iii), and (iv), (e)(2)(iv), (e)(2)(ix) and (x); remove paragraph (e)(2)(xiii); and add paragraph (e)(4) to read as follows: § 558.500 Ractopamine. * * * * * (e) * * * (4) Ractopamine may also be used in combination with tylosin in as in § 558.625. ■ 32. In § 558.515, in the table in paragraph (d), remove the row entries for ‘‘Chlortetracycline 100 to 200’’, ‘‘Chlortetracycline 200 to 400’’, ‘‘Chlortetracycline 500’’, ‘‘Lincomycin 2’’, and ‘‘Oxytetracycline 400’’ in the ‘‘Combination in grams/ton’’ column; and add paragraph (e) to read as follows: § 558.515 * * Robenidine. * * Sulfamerazine grams/ton (1) To deliver 10 grams of sulfamerazine per 100 pounds of fish per day. * Salinomycin. * * * * * (d) * * * (5) Salinomycin may also be used in combination with: (i) [Reserved] (ii) [Reserved] (iii) Chlortetracycline as in § 558.128. (iv) Lincomycin as in § 558.325. (v) Oxytetracycline as in § 558.450. (vi) Virginiamycin as in § 558.635. ■ 34. In § 558.555, remove paragraphs (d)(3) through (5); (e)(3) and (e)(4); remove and reserve paragraph (e)(2); and add paragraph (f) to read as follows: § 558.555 95013 (1) No. 054771 for use of the product described in paragraph (a)(1) as in paragraphs (e)(1), (e)(2), (e)(3), (e)(4), and (e)(7) of this section. (2) No. 015331 for use of the product described in paragraph (a)(2) as in paragraphs (e)(5) and (e)(6) of this section. * * * * * (d) Special considerations.—(1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian. See § 558.6 for additional requirements. (2) The expiration date of VFDs for sulfadimethoxine and ormetoprim medicated feeds must not exceed 6 months from the date of issuance. VFDs for sulfadimethoxine and ormetoprim shall not be refilled. * * * * * ■ 36. Revise § 558.582 to read as follows: Semduramycin. * * * * * (f) Semduramycin may also be used in combination with virginiamycin as in § 558.635. ■ 35. In § 558.575, revise the section heading; redesignate paragraphs (b), (c), and (d) as paragraphs (c), (d), and (e); revise paragraph (a); and add new paragraphs (b) and (d) to read as follows: § 558.575 Sulfadimethoxine and ormetoprim. (a) Specifications. Type A medicated articles containing either: (1) 25 percent sulfadimethoxine and 15 percent ormetoprim; or (2) 25 percent sulfadimethoxine and 5 percent ormetoprim. (b) Sponsors. See sponsors in § 510.600(c) of this chapter for use as in paragraph (d) of this section: § 558.582 Sulfamerazine. (a) Specifications. Type A medicated articles containing 99 percent sulfamerazine. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.660 of this chapter. (d) Special considerations—(1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian. See § 558.6 for additional requirements. (2) The expiration date of VFDs for sulfamerazine medicated feeds must not exceed 6 months from the date of issuance. VFDs for sulfamerazine shall not be refilled. (e) Conditions of use. It is used in fish feed for as follows: Combination in grams/ton Indications for use Limitations ................................ Rainbow trout, brook trout, and brown trout: For control of furunculosis. Formulate to deliver 10 grams of sulfamerazine per 100 pounds of fish per day. Treat for not more than 14 days. Do not treat within 3 weeks of marketing or stocking in stream open to fishing. Sponsor 054771 asabaliauskas on DSK3SPTVN1PROD with RULES (2) [Reserved]. 37. Revise § 558.586 to read as follows: ■ § 558.586 Sulfaquinoxaline. (a) Specifications. Type A medicated articles containing 40 percent sulfaquinoxaline. VerDate Sep<11>2014 19:06 Dec 23, 2016 Jkt 241001 (b) Sponsor. See No. 016592 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.685 of this chapter. (d) Special considerations—(1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of PO 00000 Frm 00105 Fmt 4700 Sfmt 4700 a licensed veterinarian. See § 558.6 for additional requirements. (2) The expiration date of VFDs for sulfaquinoxaline medicated feeds must not exceed 6 months from the date of issuance. VFDs for sulfaquinoxaline shall not be refilled. (e) Conditions of use—(1) Chickens— E:\FR\FM\27DER1.SGM 27DER1 95014 Federal Register / Vol. 81, No. 248 / Tuesday, December 27, 2016 / Rules and Regulations Sulfaquinoxaline in grams/ton Combination in grams/ton Indications for use Limitations (i) 0.015 percent ..... ................................ As an aid in preventing outbreaks of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, and E. brunetti under average conditions of exposure. (ii) 0.0175 percent .. ................................ As an aid in preventing outbreaks of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, and E. brunetti where excessive exposure to coccidia is increased due to overcrowding or other management factors. (iii) 0.1 to 0.05 percent. ................................ As an aid in controlling outbreaks of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, and E. brunetti. (iv) 0.05 or 0.1 percent. ................................ As an aid in the control of acute fowl cholera caused by Pasteurella multocida susceptible to sulfaquinoxaline and fowl typhoid caused by Salmonella gallinarum susceptible to sulfaquinoxaline. Feed continuously from the time birds are placed on litter and continue past the age when coccidiosis is ordinarily a hazard. If death losses exceed 0.5 percent in a 2-day period, obtain a laboratory diagnosis. If coccidiosis is the cause, use the sulfaquinoxaline levels recommended for control of outbreaks, returning to the original dosage schedule after the outbreak has subsided. Losses may result from intercurrent disease, other conditions affecting drug intake, or variant strains of coccidia species which can contribute to the virulence of coccidiosis under field conditions. Do not treat chickens within 10 days of slaughter. Do not medicate chickens producing eggs for human consumption. Feed continuously from the time birds are placed on litter and continue past the age when coccidiosis is ordinarily a hazard. If death losses exceed 0.5 percent in a 2-day period, obtain a laboratory diagnosis. If coccidiosis is the cause, use the sulfaquinoxaline levels recommended for control of outbreaks, returning to the original dosage schedule after the outbreak has subsided. Losses may result from intercurrent disease, other conditions affecting drug intake, or variant strains of coccidia species which can contribute to the virulence of coccidiosis under field conditions. Do not treat chickens within 10 days of slaughter. Do not medicate chickens producing eggs for human consumption. Feed at 0.1 percent level for first 48 to 72 hours. Skip 3 days; 0.05 percent for 2 days, skip 3 days; 0.05 percent for 2 days. If bloody droppings recur, give 0.05 percent for another 2 days. Do not treat chickens within 10 days of slaughter. Do not medicate chickens producing eggs for human consumption. Feed 0.1 percent for 48 to 72 hours. Mortality should be brought under control. After medication, move birds to clean ground or to a clean house. If disease recurs, use 0.05 percent in feed again for 2 days. Do not treat chickens or turkeys within 10 days of slaughter for food. Do not medicate chickens or turkeys producing eggs for human consumption. asabaliauskas on DSK3SPTVN1PROD with RULES (2) Turkeys— VerDate Sep<11>2014 19:06 Dec 23, 2016 Jkt 241001 PO 00000 Frm 00106 Fmt 4700 Sfmt 4700 E:\FR\FM\27DER1.SGM 27DER1 Sponsor 016592 016592 016592 016592 Federal Register / Vol. 81, No. 248 / Tuesday, December 27, 2016 / Rules and Regulations Sulfaquinoxaline in grams/ton Combination in grams/ton Indications for use Limitations (i) 0.0175 percent ... ................................ As an aid in preventing outbreaks of coccidiosis caused by Eimeria meleagrimitis and E. adenoeides. (ii) 0.05 percent ...... ................................ As an aid in controlling outbreaks of coccidiosis caused by Eimeria meleagrimitis and E. adenoeides. (iii) 0.05 or 0.1 percent. ................................ As an aid in the control of acute fowl cholera caused by Pasteurella multocida susceptible to sulfaquinoxaline and fowl typhoid caused by Salmonella gallinarum susceptible to sulfaquinoxaline. Feed continuously during time birds are closely confined. May be continued for a week to 10 days after flock is transferred to range to reduce danger of an outbreak following moving of the flock. Do not treat turkeys within 10 days of slaughter. Do not medicate turkeys producing eggs for human consumption. Feed for 2 days. Follow with 3 days on regular feed and 2 more days on 0.05 percent sulfaquinoxaline feed. Again follow with 3 days on regular feed and 2 more days on 0.05 percent sulfaquinoxaline feed. Continue this schedule if necessary until all signs of the outbreaks have subsided. Do not treat turkeys within 10 days of slaughter. Do not medicate turkeys producing eggs for human consumption. Feed 0.1 percent for 48 to 72 hours. Mortality should be brought under control. After medication, move birds to clean ground or to a clean house. If disease recurs, use 0.05 percent in feed again for 2 days. Do not treat chickens or turkeys within 10 days of slaughter for food. Do not medicate chickens or turkeys producing eggs for human consumption. Sulfaquinoxaline in grams/ton Combination in grams/ton Indications for use (i) 0.025 percent ..... ................................ As an aid in preventing coccidiosis caused by Eimeria stiedae. (ii) 0.1 percent ........ ................................ 95015 Sponsor 016592 016592 016592 (3) Rabbits— Treatment to be started after weaning. Feed continuously for 30 days or feed medicated feed for 2 days out of every week until marketing. Do not treat within 10 days of slaughter. As an aid in controlling outbreaks of Feed for 2 weeks. Do not treat within coccidiosis caused by Eimeria stiedae. 10 days of slaughter. 38. In § 558.612, remove paragraphs (e)(1)(i) and (e)(1)(iii); redesignate paragraphs (e)(1)(ii) and (e)(1)(iv) as new paragraphs (e)(1)(i) and (ii); and add paragraph (e)(2) to read as follows: ■ § 558.612 Tiamulin. asabaliauskas on DSK3SPTVN1PROD with RULES * * * * * (e) * * * (2) Tiamulin may also be used in combination with chlortetracycline as in § 558.128. ■ 39. Amend § 558.625 as follows: ■ a. Remove paragraph (d); ■ b. Redesignate paragraphs (c), (e), and (f) as paragraphs (d), (c) and (e); and ■ c. Revise paragraph (b) and redesignated paragraphs (d) and (e). The revisions read as follows: § 558.625 * * Tylosin. * VerDate Sep<11>2014 * * 19:06 Dec 23, 2016 Jkt 241001 Limitations (b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter. (1) No. 016592: Type medicated article containing 100 grams per pound. (2) No. 054771: Type medicated article containing 40 grams per pound. (3) No. 058198: Type medicated article containing 10, 40, or 100 grams per pound. (4) No. 066104: Type medicated article containing 20 or 40 grams per pound. (c) Related tolerances. See § 556.360 of this chapter. (d) Special considerations—(1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian. See § 558.6 for additional requirements. (2) The expiration date of VFDs for oxytetracycline medicated feeds must PO 00000 Frm 00107 Fmt 4700 Sfmt 4700 Sponsor 016592 016592 not exceed 6 months from the date of issuance. VFDs for oxytetracycline shall not be refilled. (3) Type C medicated feeds for cattle may be manufactured from tylosin liquid Type B medicated feeds which have a pH between 4.5 and 6.0 and which bear appropriate mixing directions as follows: (i) For liquid feeds stored in recirculating tank systems: Recirculate immediately prior to use for not less than 10 minutes, moving not less than 1 percent of the tank contents per minute from the bottom of the tank to the top. Recirculate daily as described even when not used. (ii) For liquid feeds stored in mechanical, air, or other agitation-type tank systems: Agitate immediately prior to use for not less than 10 minutes, creating a turbulence at the bottom of E:\FR\FM\27DER1.SGM 27DER1 95016 Federal Register / Vol. 81, No. 248 / Tuesday, December 27, 2016 / Rules and Regulations the tank that is visible at the top. Agitate daily as described even when not used. (e) Conditions of use—(1) Swine— Combination in grams/ton Indications for use Limitations (i) 40 or 100 ........... ................................ For control of swine dysentery associated with Brachyspira hyodysenteriae. (ii) 40 or 100 .......... Pyrantel, 96 ........... 016592 054771 058198 066104 066104 ................................ For control of swine dysentery associated with Brachyspira hyodysenteriae; and as an aid in the prevention of migration and establishment of large roundworm (Ascaris suum) infections; aid in the prevention of establishment of nodular worm (Oesophagostomum spp.) infections. For control of porcine proliferative enteropathies (ileitis) associated with Lawsonia intracellularis. Feed as the sole ration 100 g of tylosin per ton of complete feed for at least 3 weeks. Follow with 40 grams per ton of complete feed until market weight. Feed as the sole ration 100 g of tylosin per ton of complete feed for at least 3 weeks. Follow with 40 grams per ton of complete feed until market weight. Tylosin phosphate and pyrantel as provided by No. 066104 in § 510.600(c) of this chapter. (iii) 40 or 100 .......... (iv) 40 or 100 ......... Pyrantel, 96 ........... Feed as the sole ration 100 g of tylosin per ton of complete feed for at least 3 weeks. Follow with 40 grams per ton of complete feed until market weight. Feed as the sole ration 100 g of tylosin per ton of complete feed for at least 3 weeks. Follow with 40 grams per ton of complete feed until market weight. Tylosin phosphate and pyrantel as provided by No. 066104 in § 510.600(c) of this chapter. 016592 054771 058198 066104 066104 (v) 40 or 100 .......... Ractopamine, 4.5 to 9.0. Feed continuously as the sole ration to finishing swine weighing not less than 150 lbs for the last 45 to 90 lbs (group average) of weight gain prior to slaughter. Include 100 g/ton of tylosin for at least 3 weeks, followed by 40 g/ton until market weight. Tylosin phosphate as provided by Nos. 058198 and 016592; ractopamine as provided by Nos. 058198 and 054771 in § 510.600(c) of this chapter. 016592 054771 058198 (vi) 40 to 100 .......... ................................ Pyrantel, 96 ........... Administer as tylosin phosphate in feed continuously as the sole ration for 2 to 6 weeks, immediately after treatment with tylosin tartrate in drinking water for 3 to 10 days as in § 520.2640(d)(3) of this chapter. Administer as tylosin phosphate in feed continuously as the sole ration for 2 to 6 weeks, immediately after treatment with tylosin tartrate in drinking water for 3 to 10 days as in § 520.2640(d)(3) of this chapter. Tylosin phosphate and pyrantel as provided by No. 066104 in § 510.600(c) of this chapter. 016592 054771 058198 066104 (vii) 40 to 100 ......... (viii) 40 to 100 ........ asabaliauskas on DSK3SPTVN1PROD with RULES Tylosin grams/ton ................................ Administer as tylosin phosphate in feed continuously as the sole ration for 2 to 6 weeks, immediately after treatment with tylosin tartrate in drinking water for 3 to 10 days as in § 520.2640(d)(3) of this chapter. 016592 054771 058198 066104 VerDate Sep<11>2014 19:06 Dec 23, 2016 Jkt 241001 For control of porcine proliferative enteropathies (ileitis) associated with Lawsonia intracellularis; and as an aid in the prevention of migration and establishment of large roundworm (Ascaris suum) infections; aid in the prevention of establishment of nodular worm (Oesophagostomum spp.) infections. Finishing swine: For the control of swine dysentery associated with Brachyspira hyodysenteriae; for control of porcine proliferative enteropathies (ileitis) associated with Lawsonia intracellularis; and for increased rate of weight gain, improved feed efficiency, and increased carcass leanness in finishing swine weighing not less than 150 lbs, fed a complete ration containing at least 16% crude protein for the last 45 to 90 lbs of gain prior to slaughter. For the treatment and control of swine dysentery associated with Brachyspira hyodysenteriae immediately after medicating with tylosin in drinking water. For the treatment and control of swine dysentery associated with Brachyspira hyodysenteriae immediately after medicating with tylosin in drinking water; and as an aid in the prevention of migration and establishment of large roundworm (Ascaris suum) infections; aid in the prevention of establishment of nodular worm (Oesophagostomum spp.) infections. For the control of porcine proliferative enteropathies (PPE, ileitis) associated with Lawsonia intracellularis immediately after medicating with tylosin in drinking water. PO 00000 Frm 00108 Fmt 4700 Sfmt 4700 E:\FR\FM\27DER1.SGM 27DER1 Sponsors 066104 Federal Register / Vol. 81, No. 248 / Tuesday, December 27, 2016 / Rules and Regulations 95017 Tylosin grams/ton Combination in grams/ton Indications for use Limitations (ix) 40 to 100 .......... Pyrantel, 96 ........... Administer as tylosin phosphate in feed continuously as the sole ration for 2 to 6 weeks, immediately after treatment with tylosin tartrate in drinking water for 3 to 10 days as in § 520.2640(d)(3) of this chapter. Tylosin phosphate and pyrantel as provided by No. 066104 in § 510.600(c) of this chapter. 066104 (x) 40 to 100 .......... Ractopamine, 4.5 to 9.0. For the control of porcine proliferative enteropathies (PPE, ileitis) associated with Lawsonia intracellularis immediately after medicating with tylosin in drinking water; and as an aid in the prevention of migration and establishment of large roundworm (Ascaris suum) infections; aid in the prevention of establishment of nodular worm (Oesophagostomum spp.) infections. Finishing swine: For the treatment and control of swine dysentery associated with Brachyspira hyodysenteriae, for control of porcine proliferative enteropathies (PPE, ileitis) associated with Lawsonia intracellularis; and for increased rate of weight gain, improved feed efficiency, and increased carcass leanness in finishing swine weighing not less than 150 lbs, fed a complete ration containing at least 16% crude protein for the last 45 to 90 lbs of gain prior to slaughter. 016592 054771 058198 (xi) 100 ................... ................................ For reduction in severity of effects of atrophic rhinitis. Feed continuously as the sole ration to finishing swine weighing not less than 150 lbs for the last 45 to 90 lbs (group average) of weight gain prior to slaughter. Include 40 to 100 grams of tylosin phosphate per ton of complete feed for 2 to 6 weeks, immediately after treatment with tylosin tartrate in drinking water for 3 to 10 days as in § 520.2640(d)(3) of this chapter. Tylosin phosphate as provided by Nos. 058198 and 016592; ractopamine as provided by Nos. 058198 and 054771 in § 510.600(c) of this chapter. Feed continuously as the sole ration ..... (xii) 100 .................. Pyrantel, 96 ........... (xiii) 100 ................. Ractopamine, 4.5 to 9.0. For reduction in severity of effects of atrophic rhinitis; aid as an aid in the prevention of migration and establishment of large roundworm (Ascaris suum) infections; aid in the prevention of establishment of nodular worm (Oesophagostomum spp.) infections. For the control of porcine proliferative enteropathies (PPE, ileitis) associated with Lawsonia intracellularis; and for increased rate of weight gain, improved feed efficiency, and increased carcass leanness in finishing swine weighing not less than 150 lbs, fed a complete ration containing at least 16% crude protein for the last 45 to 90 lbs of gain prior to slaughter. Feed continuously as the sole ration. Tylosin phosphate and pyrantel as provided by No. 066104 in § 510.600(c) of this chapter. Tylosin phosphate and pyrantel as provided by No. 066104 in § 510.600(c) of this chapter. Feed continuously as the sole ration to finishing swine weighing not less than 150 lbs for the last 45 to 90 lbs (group average) of weight gain prior to slaughter. Include 100 g/ton of tylosin for 3 weeks. Tylosin phosphate as provided by Nos. 058198 and 016592; ractopamine as provided by Nos. 058198 and 054771 in § 510.600(c) of this chapter. Sponsors 016592 054771 058198 066104 066104 016592 054771 058198 (2) Cattle— Combination in grams/ton Indications for use Limitations (i) 8 to 10 ............... asabaliauskas on DSK3SPTVN1PROD with RULES Tylosin grams/ton ................................ Beef cattle: For reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes. Feed continuously as the sole ration to provide 60 to 90 mg/head/day tylosin. VerDate Sep<11>2014 19:06 Dec 23, 2016 Jkt 241001 PO 00000 Frm 00109 Fmt 4700 Sfmt 4700 E:\FR\FM\27DER1.SGM 27DER1 Sponsors 016592, 054771, 058198, 066104 95018 Federal Register / Vol. 81, No. 248 / Tuesday, December 27, 2016 / Rules and Regulations Tylosin grams/ton Combination in grams/ton Indications for use Limitations Feed continuously as sole ration. Feed to heifers at the rate of 0.5 to 2.0 pound(s) per head per day (specify one level) to provide 0.25 to 0.5 mg melengestrol acetate per head per day (specify one level), 100 to 360 mg lasalocid per head per day (specify one level), and 90 mg tylosin per head per day. This Type C product may be top dressed onto or mixed into a complete feed prior to feeding. Tylosin as provided by Nos. 058198 and 016592; lasalocid as provided by No. 054771; melengestrol as provided by Nos. 054771 and 058198 in § 510.600(c) of this chapter. Feed continuously as sole ration. Each pound contains 0.125 to 1.0 mg melengestrol acetate and 45 to 180 mg of tylosin. Feed to heifers at a rate of 0.5 to 2.0 pounds per head per day to provide 0.25 to 0.5 mg melengestrol acetate and 60 to 90 mg tylosin per head per day. Prior to feeding, this Type C product must be top-dressed onto a complete feed or mixed into the amount of complete feed consumed by an animal per day. Tylosin provided by No. 058198; melengestrol provided by No. 054771 in § 510.600(c) of this chapter. Feed continuously as sole ration to provide 50 to 480 monensin mg/head/ day and 60 to 90 mg/head/day tylosin. A withdrawal time has not been established for pre-ruminating calves. Do not use in calves to be processed for veal. Tylosin provided by Nos. 016592 or 058198; monensin as provided by No. 058198 in § 510.600(c) of this chapter. Feed continuously as sole ration to provide 0.14 to 0.42 mg monensin/lb body weight per day, depending on the severity of the coccidiosis challenge, up to 480 mg/head/day and 60 to 90 mg/head/day tylosin. A withdrawal time has not been established for pre-ruminating calves. Do not use in calves to be processed for veal. Tylosin provided by Nos. 016592 or 058198; monensin as provided by No. 058198 in § 510.600(c) of this chapter. Feed continuously as the sole ration to provide 22.7 mg of decoquinate per 100 lb body weight per day, 50 to 360 mg of monensin/head/day, and 60 to 90 mg of tylosin/head/day. Feed at least 28 days during period of exposure to coccidiosis or when it is likely to be a hazard. Do not feed to animals producing milk for food. Do not feed to lactating dairy cattle. A withdrawal time has not been established for pre-ruminating calves. Do not use in calves to be processed for veal. Tylosin as provided by Nos. 016592 and 058198; monensin as provided by No. 058198; decoquinate as provided by No. 058198 in § 510.600(c) of this chapter. Lasalocid, 100 to 1440 plus melengestrol, 0.25 to 2.0. Heifers fed in confinement for slaughter: For reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium pyogenes; and for increased rate of weight gain, improved feed efficiency, and suppression of estrus (heat). (iii) 90 to 360 .......... Melengestrol, 0.25 to 2.0. Heifers fed in confinement for slaughter: For reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium pyogenes; and for increased rate of weight gain, improved feed efficiency, and suppression of estrus (heat). (iv) 8 to 10 .............. Monensin, 5 to 40 .. Cattle fed in confinement for slaughter: For reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes; and for improved feed efficiency. (v) 8 to 10 .............. Monensin, 10 to 40 Cattle fed in confinement for slaughter: For reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes; and for prevention of coccidiosis caused by Eimeria bovis and E zuernii. (vi) 8 to 10 .............. asabaliauskas on DSK3SPTVN1PROD with RULES (ii) 90 to 360 ........... Monensin, 5 to 30 plus decoquinate, 13.6 to 22.7. Cattle fed in confinement for slaughter: For reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium pyogenes; for the prevention of coccidiosis caused by Eimeria bovis and E. zuernii; and for improved feed efficiency. VerDate Sep<11>2014 19:06 Dec 23, 2016 Jkt 241001 PO 00000 Frm 00110 Fmt 4700 Sfmt 4700 E:\FR\FM\27DER1.SGM 27DER1 Sponsors 054771 016592 054771 016592 058198 016592 058198 016592 054771 Federal Register / Vol. 81, No. 248 / Tuesday, December 27, 2016 / Rules and Regulations Combination in grams/ton Indications for use Limitations (vii) 8 to 10 ............. Monensin, 10 to 40 plus melengestrol, 0.25 to 2.0. Heifers fed in confinement for slaughter: For reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes; for prevention and control of coccidiosis caused by Eimeria bovis and E zuernii; and for increased rate of weight gain, improved feed efficiency, and suppression of estrus (heat). (viii) 8 to 10 ............ Monensin, 10 to 40 plus ractopamine, 8.2 to 24.6. Cattle fed in confinement for slaughter: For reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium pyogenes; for prevention and control of coccidiosis caused by Eimeria bovis and E zuernii; and for increased rate of weight gain and improved feed efficiency in cattle fed in confinement for slaughter for the last 28 to 42 days on feed. (ix) 8 to 10 .............. asabaliauskas on DSK3SPTVN1PROD with RULES Tylosin grams/ton Monensin, 10 to 40 plus ractopamine, not to exceed 800. Cattle fed in confinement for slaughter: For reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium pyogenes; for prevention and control of coccidiosis caused by Eimeria bovis and E zuernii; and for increased rate of weight gain and improved feed efficiency in cattle fed in confinement for slaughter for the last 28 to 42 days on feed. Feed continuously as sole ration to heifers at a rate of 0.5 to 2.0 pounds per head per day to provide 0.25 to 0.5 mg/head/day melengestrol acetate and 0.14 to 0.42 mg monensin/lb body weight per day, depending on the severity of the coccidiosis challenge, up to 480 mg/head/day and 60 to 90 mg/head/day tylosin. The melengestrol acetate portion of this Type C medicated feed must be mixed into the complete feed containing 10 to 40 g/ton monensin and 8 to 10 g/ton tylosin at feeding into the amount of complete feed consumed by an animal per day. A withdrawal time has not been established for pre-ruminating calves. Do not use in calves to be processed for veal. Tylosin provided by Nos. 016592 or 058198; monensin as provided by No. 058198; melengestrol provided by Nos. 054771 or 058198 in § 510.600(c) of this chapter. Feed continuously as sole ration to provide 70 to 430 mg/head/day ractopamine and 0.14 to 0.42 mg monensin/lb body weight per day, depending on the severity of the coccidiosis challenge, up to 480 mg/ head/day and 60 to 90 mg/head/day tylosin for the last 28 to 42 days on feed. A withdrawal time has not been established for pre-ruminating calves. Do not use in calves to be processed for veal. Tylosin provided by Nos. 016592 or 058198; monensin as provided by No. 058198; ractopamine provided by Nos. 054771 or 058198 in § 510.600(c) of this chapter. Feed a minimum of 1.0 lb/head/day ractopamine Type C top dress feed continuously to cattle fed in confinement for slaughter, to provide 70 to 400 mg/head/day ractopamine for the last 28 to 42 days on feed. Feed on top of a ration containing 10 to 40 g/ ton monensin and 8 to 10 g/ton tylosin phosphate, to provide 0.14 to 0.42 mg monensin/lb body weight/ day, depending on the severity of the coccidiosis challenge, up to 480 mg/ head/day and 60 to 90 mg/head/day tylosin. A withdrawal time has not been established for pre-ruminating calves. Do not use in calves to be processed for veal. Tylosin provided by Nos. 016592 or 058198; monensin as provided by No. 058198; ractopamine provided by Nos. 054771 or 058198 in § 510.600(c) of this chapter. VerDate Sep<11>2014 19:06 Dec 23, 2016 Jkt 241001 PO 00000 Frm 00111 Fmt 4700 Sfmt 4700 E:\FR\FM\27DER1.SGM 27DER1 95019 Sponsors 016592 054771 058198 054771 058198 054771 058198 95020 Federal Register / Vol. 81, No. 248 / Tuesday, December 27, 2016 / Rules and Regulations Combination in grams/ton Indications for use Limitations (x) 8 to 10 .............. Monensin 10 to 40 plus ractopamine 9.8 to 24.6. Cattle fed in confinement for slaughter: For reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium pyogenes; for prevention and control of coccidiosis caused by Eimeria bovis and E zuernii; and for increased rate of weight gain, improved feed efficiency, and increased carcass leanness in cattle fed in confinement for slaughter for the last 28 to 42 days on feed. (xi) 8 to 10 .............. Monensin, 10 to 40 plus ractopamine, 9.8 to 24.6 plus melengestrol, 0.125 to 1 mg/lb. Heifers fed in confinement for slaughter: For reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes; for prevention and control of coccidiosis caused by Eimeria bovis and E zuernii; for increased rate of weight gain, improved feed efficiency, and increased carcass leanness; and suppression of estrus (heat). (xii) 8 to 10 ............. Monensin, 10 to 40 plus zilpaterol, 6.8. Cattle fed in confinement for slaughter: For reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium pyogenes; for prevention and control of coccidiosis caused by Eimeria bovis and E zuernii; and for increased rate of weight gain, improved feed efficiency, and increased carcass leanness in cattle fed in confinement for slaughter for the last 20 to 40 days on feed. (xiii) 8 to 10 ............ asabaliauskas on DSK3SPTVN1PROD with RULES Tylosin grams/ton Monensin, 10 to 40 plus zilpaterol, 6.8 to 24. Cattle fed in confinement for slaughter: For reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium pyogenes; for prevention and control of coccidiosis caused by Eimeria bovis and E zuernii; and for increased rate of weight gain, improved feed efficiency, and increased carcass leanness in cattle fed in confinement for slaughter for the last 20 to 40 days on feed. Feed continuously as sole ration to provide 90 to 430 mg/head/day ractopamine and 0.14 to 0.42 mg monensin/lb body weight per day, depending on the severity of the coccidiosis challenge, up to 480 mg/ head/day and 60 to 90 mg/head/day tylosin for the last 28 to 42 days on feed. A withdrawal time has not been established for pre-ruminating calves. Do not use in calves to be processed for veal. Tylosin provided by Nos. 016592 or 058198; monensin as provided by No. 058198; ractopamine as provided by Nos. 054771 or 058198 in § 510.600(c) of this chapter. Feed continuously as sole ration to provide 90 to 430 mg/head/day ractopamine and 0.14 to 0.42 mg monensin/lb body weight per day, depending on the severity of the coccidiosis challenge, up to 480 mg/ head/day and 60 to 90 mg/head/day tylosin for the last 28 to 42 days on feed. Feed melengestrol as a top dress or mixed with a complete ration at the rate of 0.5 to 2.0 pound/head/ day (specify one level) to provide 0.25 to 0.5 mg melengestrol acetate/ head/day (specify one level). A withdrawal time has not been established for pre-ruminating calves. Do not use in calves to be processed for veal. Tylosin provided by Nos. 016592 or 058198; monensin as provided by No. 058198; ractopamine as provided by Nos. 054771 or 058198 in § 510.600(c) of this chapter. Feed continuously as the sole ration to cattle during the last 20 to 40 days on feed to provide 60 to 90 mg/head/day zilpaterol, 0.14 to 0.42 mg/lb body weight/day monensin, depending on the severity of the coccidiosis challenge, up to 480 mg/head/day monensin, and 60 to 90 mg/head/day tylosin. Do not use in veal calves. Withdrawal period 3 days. Tylosin provided by Nos. 016592 or 058198; monensin as provided by No. 058198; zilpaterol as provided by No. 000061 in § 510.600(c) of this chapter. Feed this component feed continuously to cattle during the last 20 to 40 days on feed to provide 60 mg/head/day zilpaterol, 0.14 to 0.42 mg/lb body weight/day monensin, depending on the severity of the coccidiosis challenge, up to 480 mg/head/day monensin, and 60 to 90 mg/head/day tylosin. Do not use in veal calves. Withdrawal period 3 days. Tylosin provided by Nos. 016592 or 058198; monensin as provided by No. 058198; zilpaterol as provided by No. 000061 in § 510.600(c) of this chapter. VerDate Sep<11>2014 19:06 Dec 23, 2016 Jkt 241001 PO 00000 Frm 00112 Fmt 4700 Sfmt 4700 E:\FR\FM\27DER1.SGM 27DER1 Sponsors 054771 058198 054771 058198 000061 016592 000061 016592 Federal Register / Vol. 81, No. 248 / Tuesday, December 27, 2016 / Rules and Regulations Tylosin grams/ton Combination in grams/ton Indications for use Limitations (xiv) 8 to 10 ............ Monensin, 10 to 40 plus zilpaterol, 6.8 plus melengestrol, 0.125 to 1 mg/lb. Heifers fed in confinement for slaughter: For reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes; for prevention and control of coccidiosis caused by Eimeria bovis and E zuernii; and for increased rate of weight gain, improved feed efficiency, and increased carcass leanness in cattle fed in confinement for slaughter for the last 20 to 40 days on feed; and for suppression of estrus (heat). (xv) 8 to 10 ............. Monensin, 10 to 40 plus zilpaterol, 6.8 to 24 plus melengestrol, 0.125 to 1 mg/lb. Heifers fed in confinement for slaughter: For reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes; for prevention and control of coccidiosis caused by Eimeria bovis and E zuernii; and for increased rate of weight gain, improved feed efficiency, and increased carcass leanness in cattle fed in confinement for slaughter for the last 20 to 40 days on feed; and for suppression of estrus (heat). Feed continuously as the sole ration to cattle during the last 20 to 40 days on feed to provide 60 to 90 mg/head/day zilpaterol, 0.14 to 0.42 mg/lb body weight/day monensin, depending on the severity of the coccidiosis challenge, up to 480 mg/head/day monensin, and 60 to 90 mg/head/day tylosin. Feed melengestrol as a top dress or mixed with a complete ration at the rate of 0.5 to 2.0 pound/head/ day (specify one level) to provide 0.25 to 0.5 mg melengestrol acetate/ head/day (specify one level). Do not use in veal calves. Withdrawal period 3 days. Tylosin as provided by Nos. 016592 or 058198; monensin as provided by No. 058198; zilpaterol as provided by No. 000061; melengestrol provided by Nos. 054771 or 058198 in § 510.600(c) of this chapter. Feed this component feed continuously to cattle during the last 20 to 40 days on feed to provide 60 mg/head/day zilpaterol, 0.14 to 0.42 mg/lb body weight/day monensin, depending on the severity of the coccidiosis challenge, up to 480 mg/head/day monensin, and 60 to 90 mg/head/day tylosin. Feed melengestrol as a top dress or mixed with a complete ration at the rate of 0.5 to 2.0 pound/head/ day (specify one level) to provide 0.25 to 0.5 mg melengestrol acetate/ head/day (specify one level). Do not use in veal calves. Withdrawal period 3 days. Tylosin as provided by Nos. 016592 or 058198; monensin as provided by No. 058198; zilpaterol as provided by No. 000061; melengestrol provided by Nos. 054771 or 058198 in § 510.600(c) of this chapter. 40. Revise § 558.630 to read as follows: ■ § 558.630 Tylosin and sulfamethazine. asabaliauskas on DSK3SPTVN1PROD with RULES (a) Specifications. Type A medicated articles containing equal amounts of tylosin phosphate and sulfamethazine, available in concentrations of 5, 10, 20, or 40 grams each, per pound. (b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter. VerDate Sep<11>2014 19:06 Dec 23, 2016 Jkt 241001 (1) No. 058198 for use as in paragraph (e)(1) of this section. (2) No. 054771: 10 or 40 grams per pound each for use as in paragraph (e)(2) of this section. (c) Related tolerances. See §§ 556.670 and 556.740 of this chapter. (d) Special considerations—(1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of PO 00000 Frm 00113 Fmt 4700 Sfmt 4700 95021 Sponsors 000061 016592 058198 000061 016592 058198 a licensed veterinarian. See § 558.6 for additional requirements. (2) The expiration date of VFDs for tylosin and sulfamethazine medicated feeds must not exceed 6 months from the date of issuance. VFDs for tylosin and sulfamethazine shall not be refilled. (3) Labeling shall bear the statement: ‘‘Do not use in medicated feeds containing in excess of 2% bentonite.’’ (e) Conditions of use. It is used in feed for swine as follows: E:\FR\FM\27DER1.SGM 27DER1 95022 Federal Register / Vol. 81, No. 248 / Tuesday, December 27, 2016 / Rules and Regulations Tylosin phosphate and sulfamethazine in grams/ton Combination in grams/ton Indications for use Limitations (1) 100 each ........... ................................ Withdraw 15 days before swine are slaughtered. 058198 (2) 100 each ........... ................................ For reduction in the severity of effects of atrophic rhinitis; lowering the incidence and severity of Bordetella bronchiseptica rhinitis; prevention of swine dysentery associated with Brachyspira hyodysenteriae; control of swine pneumonias caused by bacterial pathogens (Pasteurella multocida and/or Arcanobacterium pyogenes); reducing the incidence of cervical lymphadenitis (jowl abscesses) caused by Group E Streptococci. Only the sulfamethazine portion of this combination is active in controlling jowl abscesses. For reduction in the severity of effects of atrophic rhinitis; lowering the incidence and severity of Bordetella bronchiseptica rhinitis; prevention of swine dysentery associated with Brachyspira hyodysenteriae; and control of swine pneumonias caused by bacterial pathogens (Pasteurella multocida and/or Arcanobacterium pyogenes). Withdraw 15 days before swine are slaughtered. 054771 41. Revise § 558.635 to read as follows: ■ § 558.635 Virginiamycin. (a) Specifications. Type A medicated articles containing 5, 10, 20, 50, 136.2, or 227 grams per pound virginiamycin. (b) Sponsors. See No. 066104 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.750 of this chapter. (d) Special considerations—(1) [Reserved] (2) [Reserved] Sponsors (3) Not for use in breeding swine over 120 pounds. (4) Dilute Type A article with at least 10 pounds of a feed ingredient prior to final mixing in 1 ton of Type C feed. (e) Conditions of use—(1) Chickens— Combination in grams/ton Indications for use Limitations (i) 5 ......................... ................................ 066104 Monensin, 90 to 110. Salinomycin, 40 to 60. (iv) 5 ....................... Semduramicin, 22.7 Feed continuously as the sole ration. Do not feed to laying chickens. Virginiamycin as provided by No. 066104; monensin as provided by No. 058198 in § 510.600(c) of this chapter. Feed continuously as the sole ration. Do not feed to layers or to chickens over 16 weeks of age. Not approved for use with pellet binders. May be fatal if accidentally fed to adult turkeys or horses. Virginiamycin as provided by No. 066104; salinomycin as provided by No. 054771 in § 510.600(c) of this chapter. Feed continuously as the sole ration. Do not feed to laying hens. Semduramicin as provided by No. 066104 in § 510.600(c) of this chapter. 066104 (iii) 5 ....................... Broiler chickens: For increased rate of weight gain and improved feed efficiency. Broiler chickens: For increased rate of weight gain and improved feed efficiency; as an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. maxima, and E. mivati. Broiler chickens: For increased rate of weight gain and improved feed efficiency; for prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati. Not for use in layers .............................. (ii) 5 ........................ asabaliauskas on DSK3SPTVN1PROD with RULES Virginiamycin grams/ton (v) 5 ........................ Semduramicin (biomass), 22.7. (vi) 5 to 15 .............. VerDate Sep<11>2014 19:06 Dec 23, 2016 Jkt 241001 Broiler chickens: For increased rate of weight gain and improved feed efficiency; for the prevention of coccidiosis caused by Eimeria acervulina, E. brunetti, E. maxima, E. mivati/mitis, E. necatrix, and E. tenella. Broiler chickens: For increased rate of weight gain and improved feed efficiency; for the prevention of coccidiosis caused by Eimeria acervulina, E. brunetti, E. maxima, E. mivati/mitis, E. necatrix, and E. tenella. Broiler chickens: For increased rate of weight gain. PO 00000 Frm 00114 Fmt 4700 Sfmt 4700 Sponsors 066104 016592 066104 Feed continuously as the sole ration. Withdraw 1 day before slaughter. Do not feed to laying hens. Virginiamycin and semduramicin as provided by No. 066104 in § 510.600(c) of this chapter. 066104 Not for use in layers .............................. 066104 E:\FR\FM\27DER1.SGM 27DER1 Federal Register / Vol. 81, No. 248 / Tuesday, December 27, 2016 / Rules and Regulations Virginiamycin grams/ton Combination in grams/ton Indications for use Limitations Feed continuously as the sole ration and as the sole source of amprolium. Do not feed to laying chickens. Not for chickens over 16 weeks of age. Virginiamycin as provided by No. 066104; amprolium and ethopabate as provided by No. 016592 in § 510.600(c) of this chapter. Feed continuously as the sole ration. Do not feed to laying chickens. Monensin as provided by No. 000986 in § 510.600(c) of this chapter. 066104 Feed continuously as the sole ration. Do not feed to layers or to chickens over 16 weeks of age. Not approved for use with pellet binders. May be fatal if accidentally fed to adult turkeys or horses. Virginiamycin as provided by No. 066104; salinomycin as provided by Nos. 016592 or 054771 in § 510.600(c) of this chapter. Feed continuously as the sole ration. Do not feed to laying hens. Semduramicin as provided by No. 066104 in § 510.600(c) of this chapter. 016592 066104 Feed continuously as the sole ration. Withdraw 1 day before slaughter. Do not feed to laying hens. Virginiamycin as provided by No. 066104; semduramicin as provided by No. 066104 in § 510.600(c) of this chapter. Feed continuously as the sole ration and as the sole source of amprolium. Do not feed to laying chickens. Not for chickens over 16 weeks of age. Virginiamycin as provided by No. 066104; amprolium and ethopabate as provided by No. 016592 in § 510.600(c) of this chapter. Not for use in layers .............................. 066104 (vii) 5 to 15 ............. Amprolium, 113.5 and ethopabate, 36.3. Broiler chickens: For increased rate of weight gain; as an aid in the prevention of coccidiosis where severe exposure to coccidiosis from Eimeria acervulina, E. maxima, and E. brunetti is likely to occur. (viii) 5 to 15 ............ Monensin, 90 to 110. (ix) 5 to 15 .............. Salinomycin, 40 to 60. Broiler chickens: For increased rate of weight gain; as an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. maxima, and E. mivati. Broiler chickens: For increased rate of weight gain; as an aid in the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati. (x) 5 to 15 .............. Semduramicin, 22.7 (xi) 5 to 15 .............. Semduramicin (biomass), 22.7. (xii) 15 .................... Amprolium, 113.5 and ethopabate, 36.3. (xiii) 20 ................... Lasalocid, 68 to 113. (xv) 20 .................... Monensin, 90 to 110. (xvi) 20 ................... asabaliauskas on DSK3SPTVN1PROD with RULES (xiv) 20 ................... Semduramicin, 22.7 (xvii) 20 .................. Semduramicin (biomass), 22.7. VerDate Sep<11>2014 19:06 Dec 23, 2016 Jkt 241001 95023 Broiler chickens: For increased rate of weight gain; for the prevention of coccidiosis caused by Eimeria acervulina, E. brunetti, E. maxima, E. mivati/mitis, E. necatrix, and E. tenella. Broiler chickens: For increased rate of weight gain; for the prevention of coccidiosis caused by Eimeria acervulina, E. brunetti, E. maxima, E mivati/mitis, E. necatrix, and E. tenella. Broiler chickens: For increased rate of weight gain and improved feed efficiency; as an aid in the prevention of coccidiosis where severe exposure to coccidiosis from Eimeria acervulina, E. maxima, and E. brunetti is likely to occur. Broiler chickens: For prevention of necrotic enteritis caused by Clostridium spp. susceptible to virginiamycin. Broiler chickens: For increased rate of weight gain and improved feed efficiency; for prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxima. Broiler chickens: For prevention of necrotic enteritis caused by Clostridium spp. susceptible to virginiamycin; and as an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. maxima, and E. mivati. Broiler chickens: For prevention of necrotic enteritis caused by Clostridium spp. susceptible to virginiamycin; for the prevention of coccidiosis caused by Eimeria acervulina, E. brunetti, E. maxima, E. mivati/mitis, E. necatrix, and E. tenella. Broiler chickens: For prevention of necrotic enteritis caused by Clostridium spp. susceptible to virginiamycin; for the prevention of coccidiosis caused by Eimeria acervulina, E. brunetti, E. maxima, E. mivati/mitis, E. necatrix, and E. tenella. PO 00000 Frm 00115 Fmt 4700 Sfmt 4700 Sponsors 066104 066104 066104 066104 Feed continuously as the sole ration. Do not feed to laying chickens. Lasalocid sodium as provided by No. 054771 in § 510.600(c) of this chapter. 066104 Feed continuously as the sole ration. Do not feed to laying chickens. Monensin as provided by No. 058198 in § 510.600(c) of this chapter. 066104 Feed continuously as the sole ration. Do not feed to laying hens. Semduramicin as provided by No. 066104 in § 510.600(c) of this chapter. 066104 Feed continuously as the sole ration. Withdraw 1 day before slaughter. Do not feed to laying hens. Semduramicin as provided by No. 066104 in § 510.600(c) of this chapter. 066104 E:\FR\FM\27DER1.SGM 27DER1 95024 Federal Register / Vol. 81, No. 248 / Tuesday, December 27, 2016 / Rules and Regulations (2) Turkeys— Virginiamycin grams/ton Combination in grams/ton Indications for use Limitations (i) 10 to 20 ............. ................................ Not for use in layers .............................. 066104 (ii) 10 to 20 ............. Lasalocid, 68 to 113. Lasalocid sodium as provided by No. 054771 in § 510.600(c) of this chapter. 054771 (iii) 10 to 20 ............ Monensin, 90 to 110. Growing turkeys: For increased rate of weight gain and improved feed efficiency. Growing turkeys: For increased rate of weight gain and improved feed efficiency; and for the prevention of coccidiosis caused by Eimeria meleagrimitis, E. gallopavonis, and E. adenoeides. Growing turkeys: For increased rate of weight gain and improved feed efficiency; and for the prevention of coccidiosis caused by Eimeria meleagrimitis, E. gallopavonis, and E. adenoeides. Monensin as provided by No. 058198 in § 510.600(c) of this chapter. 066104 Sponsors (3) Swine— Virginiamycin grams/ton Combination in grams/ton Indications for use Limitations (i) 5 or 10 ............... ................................ Growing-finishing swine: For increased rate of weight gain and improved feed efficiency. (ii) 5 to 10 ............... ................................ Growing-finishing swine: For increased rate of weight gain. (iii) 25 ..................... ................................ (iv) 50 or 100 ......... ................................ (v) 100 .................... ................................ Growing-finishing swine: As an aid in control of dysentery in swine up to 120 pounds in animals or on premises with a history of swine dysentery but where symptoms have not yet occurred. Growing-finishing swine: For treatment and control of swine dysentery in swine up to 120 pounds. Growing-finishing swine: For treatment of swine dysentery in nonbreeding swine over 120 pounds. Feed continuously from weaning to market weight. Feed 10 grams per ton from weaning up to 120 pounds, followed by 5 grams per ton to market weight. Feed continuously from weaning to market weight. Feed 10 grams per ton from weaning up to 120 pounds for increased rate of weight gain and improved feed efficiency, followed by 5 to 10 grams per ton to market weight for increased rate of weight gain. ................................................................ Sponsors 066104 066104 066104 Feed 100 grams per ton for 2 weeks, 50 grams per ton thereafter. 066104 Feed for 2 weeks ................................... 066104 (4) Cattle— Combination in grams/ton Indications for use Limitations (i) 11.0 to 16.0 ....... ................................ Cattle fed in confinement for slaughter: For improved feed efficiency. (ii) 13.5 to 16.0 ....... asabaliauskas on DSK3SPTVN1PROD with RULES Virginiamycin grams/ton ................................ Cattle fed in confinement for slaughter: For reduction of incidence of liver abscesses. (iii) 16.0 to 22.5 ...... ................................ Cattle fed in confinement for slaughter: For increased rate of weight gain. Feed continuously as the sole ration to provide 70 to 240 milligrams per head per day. Not for use in animals intended for breeding. Feed continuously as the sole ration to provide 85 to 240 milligrams per head per day. Not for use in animals intended for breeding. Feed continuously as the sole ration to provide 100 to 340 milligrams per head per day. Not for use in animals intended for breeding. VerDate Sep<11>2014 19:06 Dec 23, 2016 Jkt 241001 PO 00000 Frm 00116 Fmt 4700 Sfmt 4700 E:\FR\FM\27DER1.SGM 27DER1 Sponsors 066104 066104 066104 Federal Register / Vol. 81, No. 248 / Tuesday, December 27, 2016 / Rules and Regulations 42. In § 558.665, remove and reserve paragraphs (e)(5) and (6); remove paragraphs (e)(11) and (12); and add paragraph (f) to read as follows: DEPARTMENT OF HEALTH AND HUMAN SERVICES § 558.665 21 CFR Part 558 ■ Food and Drug Administration Zilpaterol. * * * * * (f) Zilpaterol may also be used in combination with tylosin as in § 558.625. [Docket No. FDA–2016–N–0002] 43. In § 558.680, remove paragraph (d)(1)(x); and add paragraph (e)(3) to read as follows: § 558.680 AGENCY: Food and Drug Administration, HHS. ACTION: Zoalene. Notification of withdrawal. The Food and Drug Administration (FDA) is withdrawing approval of 11 new animal drug applications (NADAs) and 4 abbreviated new animal drug applications (ANADAs). These withdrawals of approval of NADAs and ANADAs for antimicrobial drugs of importance to human medicine that are administered to food-producing animals in medicated feed are being made because the products are no longer being manufactured or marketed. These actions are consistent with the FDA Center for Veterinary Medicine’s initiative for the Judicious Use of Antimicrobials. DATES: Withdrawal of approval is effective December 30, 2016. SUMMARY: * * * * * (e) * * * (3) Zoalene may also be used in combination with lincomycin as in § 558.325. Dated: December 20, 2016. Tracey H. Forfa, Deputy Director, Center for Veterinary Medicine. [FR Doc. 2016–31083 Filed 12–23–16; 8:45 am] BILLING CODE 4164–01–P File No. 035–287 .... LINCOMIX (lincomycin hydrochloride monohydrate) Type A Medicated Article. OM–5 Premix (oleandomycin) Type A Medicated Article ............ 046–668 .... Penicillin G Procaine 50% Type A Medicated Article .................. 091–668 .... CHLORMAX–SP 500 (chlortetracycline, sulfamethazine, penicillin G procaine) Type A Medicated Article. LINCOMIX (lincomycin)/NICARB (nicarbazin) .............................. 108–116 .... 133–334 .... 139–473 .... FDA is withdrawing approval of 11 NADAs and 4 ANADAs. 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 withdrawal of approval is consistent with the FDA Center for Veterinary Medicine’s initiative for the Judicious Use of Antimicrobials. Approval of the following applications for new animal drugs administered in medicated feed is being voluntarily withdrawn at the sponsors’ requests because these products are no longer manufactured or marketed: Sponsor 140–443 .... 140–947 .... 141–090 .... Virginiamycin Type A Medicated Article ....................................... STAFAC (virginiamycin)/STENEROL (halofuginone hydrobromide). LINCOMIX (lincomycin)/STENOROL (halofuginone hydrobromide). HYGROMIX 1.6 (hygromycin B) Type A Medicated Article ......... LINCOMIX (lincomycin)/MAXIBAN (narasin and nicarbazin) ....... STAFAC (virginiamycin)/CLINICOX (diclazuril) ............................ 200–171 .... LINCOMIX (lincomycin)/NICARMIX (nicarbazin) .......................... 200–569 .... TYLAN (tylosin)/SACOX (salinomycin) ......................................... 200–570 .... TYLOVET 100 (tylosin)/BIO–COX (salinomycin) ......................... 200–580 .... TYLOVET 100 (tylosin)/SACOX (salinomycin) ............................. 140–340 .... asabaliauskas on DSK3SPTVN1PROD with RULES Sujaya Dessai, Center for Veterinary Medicine (HFV–212), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240–402–5761, sujaya.dessai@fda.hhs.gov. Product name 034–085 .... FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: New Animal Drugs; Withdrawal of Approval of New Animal Drug Applications ■ Therefore, under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for VerDate Sep<11>2014 19:06 Dec 23, 2016 Jkt 241001 Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007. Phibro Animal Health Corp., GlenPointe Centre East, 3d Floor, 300 Frank W. Burr Blvd., Suite 21, Teaneck, NJ 07666. Phibro Animal Health Corp., GlenPointe Centre East, 3d Floor, 300 Frank W. Burr Blvd., Suite 21, Teaneck, NJ 07666. Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007. Phibro Animal Health Corp., GlenPointe Centre East, 3d Floor, 300 Frank W. Burr Blvd., Suite 21, Teaneck, NJ 07666. Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007. Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str., 1113 Sophia, Bulgaria. Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str., 1113 Sophia, Bulgaria. Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007. Elanco US, Inc., 2500 Innovation Way, Greenfield, IN 46140. Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str., 1113 Sophia, Bulgaria. Planalquimica Industrial Ltda., Rua das Magnolias nr. 2405, Jardim das Bandeiras, CEP 13053–120, Campinas, Sao Paulo, Brazil. Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str., 1113 Sophia, Bulgaria. Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str., 1113 Sophia, Bulgaria. Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str., 1113 Sophia, Bulgaria. Veterinary Medicine, and in accordance with § 514.116 Notice of withdrawal of approval of application (21 CFR PO 00000 95025 Frm 00117 Fmt 4700 Sfmt 4700 514.116), notice is given that approval of NADAs 034–085, 035–287, 046–668, 091–668, 108–116, 133–334, 139–473, E:\FR\FM\27DER1.SGM 27DER1

Agencies

[Federal Register Volume 81, Number 248 (Tuesday, December 27, 2016)]
[Rules and Regulations]
[Pages 94991-95025]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-31083]


-----------------------------------------------------------------------

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: Final rule; technical amendment.

-----------------------------------------------------------------------

SUMMARY: 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 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 non-substantive 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:

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 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 
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 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:

------------------------------------------------------------------------
      File No.           Animal drug product             Sponsor
------------------------------------------------------------------------
006-391.............  S.Q. 40%                  Huvepharma EOOD, 5th
                       (sulfaquinoxaline) Type   Floor, 3A Nikolay
                       A Medicated Article.      Haytov Str., 1113
                                                 Sophia, Bulgaria
                                                 (Huvepharma EOOD).
008-804.............  TM-50 or TM-100           Phibro Animal Health
                       (oxytetracycline) Type    Corp., GlenPointe
                       A Medicated Article.      Centre East, 3d Floor,
                                                 300 Frank W. Burr
                                                 Blvd., Suite 21,
                                                 Teaneck, NJ 07666
                                                 (Phibro Animal Health
                                                 Corp.).
010-092.............  GALLIMYCIN-100P           Cross Vetpharm Group
                       (erythromycin) Type A     Ltd., Broomhill Rd.,
                       Medicated Article.        Tallaght, Dublin 24,
                                                 Ireland (Cross Vetpharm
                                                 Group Ltd.).
010-918.............  HYGROMIX 8 (hygromycin    Elanco US Inc., 2500
                       B) Type A Medicated       Innovation Way,
                       Article.                  Greenfield, IN 46140
                                                 (Elanco US Inc.).
012-491.............  TYLAN (tylosin) Type A    Elanco US Inc.
                       Medicated Article.
033-950.............  Sulfamerazine In Fish     Zoetis Inc., 333 Portage
                       Grade.                    St., Kalamazoo, MI
                                                 49007 (Zoetis Inc.).
035-688.............  AUREOMIX S 40/40          Zoetis Inc.
                       (chlortetracycline and
                       sulfamethazine)
                       Granular Type A
                       Medicated Article.
035-805.............  AUREO S 700               Zoetis Inc.
                       (chlortetracycline and
                       sulfamethazine)
                       Granular Type A
                       Medicated Article.
038-439.............  TERRAMYCIN 200            Phibro Animal Health
                       (oxytetracycline) for     Corp.
                       Fish Type A Medicated
                       Article.
040-209.............  ROFENAID 40               Zoetis Inc.
                       (sulfadimethoxine and
                       ormetoprim) Type A
                       Medicated Article.

[[Page 94992]]

 
041-275.............  TYLAN 40 Sulfa-G          Elanco US Inc.
                       (tylosin and
                       sulfamethazine) Type A
                       Medicated Article.
041-647.............  AUREOMIX S 700-A          Zoetis Inc.
                       (chlortetracycline and
                       sulfamethazine) Type A
                       Medicated Article.
041-648.............  AUREOMIX S 700-D          Zoetis Inc.
                       (chlortetracycline and
                       sulfamethazine) Type A
                       Medicated Article.
041-649.............  AUREOMIX S 700-G          Zoetis Inc.
                       (chlortetracycline and
                       sulfamethazine) Type A
                       Medicated Article.
041-650.............  AUREOMIX S 700-E          Zoetis Inc.
                       (chlortetracycline and
                       sulfamethazine) Type A
                       Medicated Article.
041-651.............  AUREOMIX S 700-F          Zoetis Inc.
                       (chlortetracycline and
                       sulfamethazine) Type A
                       Medicated Article.
041-652.............  AUREOMIX S 700-C-2        Zoetis Inc.
                       (chlortetracycline and
                       sulfamethazine) Type A
                       Medicated Article.
041-653.............  AUREOMIX S 700-B          Zoetis Inc.
                       (chlortetracycline and
                       sulfamethazine) Type A
                       Medicated Article.
041-654.............  AUREOMIX S 700-H          Zoetis Inc.
                       (chlortetracycline and
                       sulfamethazine) Type A
                       Medicated Article.
046-415.............  Tylosin Type A Medicated  Zoetis Inc.
                       Article.
046-699.............  CHLORMAX                  Zoetis Inc.
                       (chlortetracycline)
                       Type A Medicated
                       Article.
048-480.............  CHLORATET                 Pharmgate LLC, 1015
                       (chlortetracycline)       Ashes Dr., Suite 102,
                       Type A Medicated          Wilmington, NC 28405
                       Article.                  (Pharmgate LLC).
048-761.............  AUREOMYCIN                Zoetis Inc.
                       (chlortetracycline)
                       Type A Medicated
                       Article.
049-287.............  CHLORACHEL                Zoetis Inc.
                       (chlortetracycline)Type
                       A Medicated Article.
091-749.............  TYLAN 40 Plus Sulfa-G     Zoetis Inc.
                       (tylosin and
                       sulfamethazine) Type A
                       Medicated Article.
092-286.............  CLTC-50 MR                Phibro Animal Health
                       (chlortetracycline)       Corp.
                       Type A Medicated
                       Article.
092-287.............  CLTC 100 MR               Phibro Animal Health
                       (chlortetracycline)       Corp.
                       Type A Medicated
                       Article.
094-975.............  NEO-TERRAMYCIN 100/100    Phibro Animal Health
                       (oxytetracycline and      Corp.
                       neomycin) Type A
                       Medicated Article.
095-143.............  TERRAMYCIN 10, 30, 50,    Phibro Animal Health
                       100, or 200               Corp.
                       (oxytetracycline) Type
                       A Medicated Article.
097-505.............  LINCOMIX 20 (lincomycin)  Zoetis Inc.
                       Type A Medicated
                       Article.
098-431.............  TYLAN 10 (tylosin)        Phibro Animal Health
                       Premix Type A Medicated   Corp.
                       Article.
100-901.............  PFICHLOR 100S             Zoetis Inc.
                       (chlortetracycline)
                       Milk Replacer Type A
                       Medicated Article.
125-933.............  ROMET-30 (ormetoprim and  Pharmaq AS.
                       sulfadimethoxine) Type
                       A Medicated Article.
126-050.............  APRALAN 75 (apramycin)    Elanco US Inc.
                       Type A Medicated
                       Article.
138-934.............  PENNCHLOR S 40/40         Pharmgate LLC.
                       (chlortetracycline and
                       sulfamethazine) Type A
                       medicated article.
138-935.............  PENNCHLOR 100 MR          Pharmgate LLC.
                       (chlortetracycline)
                       Type A Medicated
                       Article.
138-938.............  PENNOX 50, 100, or 200    Pharmgate LLC.
                       Hi-Flo, or 100-MR
                       (oxytetracycline) Type
                       A Medicated Article.
138-939.............  NEO-OXY 100/100 MR        Pharmgate LLC.
                       (oxytetracycline and
                       neomycin) Type A
                       Medicated Article.
140-976.............  NEOMIX 325 Milk Replacer  Zoetis Inc.
                       (neomycin) Type A
                       Medicated Article.
200-314.............  PENNCHLOR S               Pharmgate LLC.
                       (chlortetracycline and
                       sulfamethazine) Type A
                       Medicated Article.
200-484.............  TYLOVET 100 (tylosin)     Huvepharma.
                       Type A Medicated
                       Article.
200-510.............  DERACIN 100               Pharmgate LLC.
                       (chlortetracycline)
                       Type A Medicated
                       Article.
------------------------------------------------------------------------

    The affected applications for manufacturing combination drug 
medicated feeds follow:

------------------------------------------------------------------------
        File No.           Animal drug product            Sponsor
------------------------------------------------------------------------
036-361................  CTC Sodium Sulfate       Zoetis Inc., 333
                          (chlortetracycline and   Portage St.,
                          sodium sulfate)/AMPROL   Kalamazoo, MI 49007
                          PLUS (amprolium and      (Zoetis Inc.).
                          ethopabate).
045-444................  CHLORMAX                 Zoetis Inc.
                          (chlortetracycline)/
                          DECCOX (decoquinate).
046-209................  CTC (chlortetracycline)/ Huvepharma EOOD, 5th
                          COYDEN (clopidol).       Floor, 3A Nikolay
                                                   Haytov Str., 1113
                                                   Sophia, Bulgaria
                                                   (Huvepharma EOOD).
092-507................  AUREOMYCIN               Zoetis Inc.
                          (chlortetracycline)/
                          ROBENZ (robenidine).
099-006................  TERRAMYCIN               Phibro Animal Health
                          (oxytetracycline)/       Corp., GlenPointe
                          COBAN (monensin).        Centre East, 3d
                                                   Floor, 300 Frank W.
                                                   Burr Blvd., Suite 21,
                                                   Teaneck, NJ 07666
                                                   (Phibro Animal Health
                                                   Corp.).
101-666................  TERRAMYCIN               Phibro Animal Health
                          (oxytetracycline)/       Corp.
                          ROBENZ (robenidine).

[[Page 94993]]

 
104-646................  TYLAN (tylosin)/         Elanco US Inc., 2500
                          RUMENSIN (monensin).     Innovation Way,
                                                   Greenfield, IN 46140
                                                   (Elanco US Inc.).
110-047................  TYLAN (tylosin)/         Phibro Animal Health
                          BANMINTH (pyrantel).     Corp.
116-044................  LINCOMIX (lincomycin)/   Phibro Animal Health
                          BANMINTH (pyrantel).     Corp.
121-553................  AUREOMYCIN               Zoetis Inc.
                          (chlortetracycline)/
                          COBAN (monensin).
138-870................  TYLAN (tylosin)/         Zoetis Inc.
                          RUMENSIN (monensin)/
                          MGA (melengestrol).
138-941................  LINCOMIX (lincomycin)/   Zoetis Inc.
                          BANMINTH (pyrantel).
138-992................  TYLAN (tylosin)/BOVATEC  Zoetis Inc.
                          (lasalocid)/MGA
                          (melengestrol).
138-995................  TYLAN (tylosin)/MGA      Zoetis Inc.
                          (melengestrol).
139-192................  TYLAN (tylosin)/MGA      Zoetis Inc.
                          (melengestrol).
140-448................  TERRAMYCIN               Phibro Animal Health
                          (oxytetracycline)/BIO-   Corp.
                          COX (salinomycin).
140-859................  AUREOMYCIN               Zoetis Inc.
                          (chlortetracycline)/
                          BIO-COX (salinomycin).
140-954................  LINCOMIX (lincomycin)/   Intervet, Inc.
                          SAFE-GUARD
                          (fenbendazole).
141-011................  CTC (chlortetracycline)/ Elanco US Inc.
                          DENAGARD (tiamulin).
141-054................  LINCOMIX (lincomycin)/   Merial, Inc., 3239
                          IVOMEC (ivermectin).     Satellite Blvd.,
                                                   Bldg. 500, Duluth, GA
                                                   30096-4640.
141-059................  CHLORMAX                 Zoetis Inc.
                          (chlortetracycline)/
                          BMD (bacitracin).
141-147................  CHLORMAX                 Zoetis Inc.
                          (chlortetracycline)/
                          DECCOX (decoquinate).
141-149................  TYLAN (tylosin)/         Zoetis Inc.
                          RUMENSIN (monensin)/
                          DECCOX (decoquinate).
141-172................  TYLAN (tylosin)/PAYLEAN  Elanco US Inc.
                          (ractopamine).
141-185................  AUREOMYCIN               Zoetis Inc.
                          (chlortetracycline)/
                          DECCOX (decoquinate).
141-201................  AUREOMYCIN               Zoetis Inc.
                          (chlortetracycline)/
                          CATTLYST (laidlomycin).
141-211................  TERRAMYCIN               Phibro Animal Health
                          (oxytetracycline)/       Corp.
                          (carbadox).
141-224................  TYLAN (tylosin)/         Elanco US Inc.
                          RUMENSIN (monensin)/
                          OPTAFLEXX
                          (ractopamine).
141-233................  TYLAN (tylosin)/         Elanco US Inc.
                          RUMENSIN (monensin)/
                          OPTAFLEXX
                          (ractopamine)/MGA
                          (melengestrol).
141-250................  AUREOMYCIN               Zoetis Inc.
                          (chlortetracycline)/
                          BOVATEC (lasalocid).
141-276................  TYLAN (tylosin)/         Intervet, Inc., 2
                          RUMENSIN (monensin)/     Giralda Farms,
                          ZILMAX (zilpaterol).     Madison, NJ 07940
                                                   (Intervet, Inc.).
141-280................  TYLAN (tylosin)/         Intervet, Inc.
                          RUMENSIN (monensin)/
                          ZILMAX (zilpaterol)/
                          MGA (melengestrol).
200-095................  AUREOMYCIN               Huvepharma EOOD.
                          (chlortetracycline)/
                          SACOX (salinomycin).
200-096................  TERRAMYCIN               Huvepharma EOOD.
                          (oxytetracycline)/
                          SACOX (salinomycin).
200-242................  AUREOMYCIN               Zoetis Inc.
                          (chlortetracycline)/
                          BMD (bacitracin).
200-261................  CHLORMAX                 Zoetis Inc.
                          (chlortetracycline)/
                          BIO-COX (salinomycin).
200-262................  CHLORMAX                 Zoetis Inc.
                          (chlortetracycline)/
                          SACOX (salinomycin).
200-263................  CHLORMAX                 Zoetis Inc.
                          (chlortetracycline)/
                          COBAN (monensin).
200-354................  PENNCHLOR                Pharmgate LLC, 1015
                          (chlortetracycline)/     Ashes Dr., Suite 102,
                          COBAN (monensin).        Wilmington, NC 28405
                                                   (Pharmgate LLC).
200-356................  PENNCHLOR                Pharmgate LLC.
                          (chlortetracycline)/
                          DENAGARD (tiamulin).
200-357................  PENNCHLOR                Pharmgate LLC.
                          (chlortetracycline)/
                          BIO-COX (salinomycin).
200-358................  PENNCHLOR                Pharmgate LLC.
                          (chlortetracycline)/
                          BMD (bacitracin).
200-359................  PENNCHLOR                Pharmgate LLC.
                          (chlortetracycline)/
                          DECCOX (decoquinate).
200-375................  TYLAN (tylosin)/         Elanco US Inc.
                          RUMENSIN (monensin)/
                          HEIFERMAX
                          (melengestrol).
200-424................  TYLAN (tylosin)/         Elanco US Inc.
                          RUMENSIN (monensin)/
                          OPTAFLEXX
                          (ractopamine)/
                          HEIFERMAX
                          (melengestrol).
200-427................  TYLAN (tylosin)/         Elanco US Inc.
                          HEIFERMAX 500
                          (melengestrol) Liquid.
200-430................  TYLAN (tylosin)/BOVATEC  Elanco US Inc.
                          (lasalocid)/HEIFERMAX
                          500 (melengestrol)
                          Liquid.
200-480................  TYLAN (tylosin)/         Elanco US Inc.
                          RUMENSIN (monensin)/
                          ZILMAX (zilpaterol)/
                          HEIFERMAX 500
                          (melengestrol).
200-530................  TYLOVET (tylosin)/       Huvepharma EOOD.
                          PAYLEAN (ractopamine).
200-531................  TYLOVET (tylosin)/       Huvepharma EOOD.
                          RUMENSIN (monensin).
200-532................  TYLOVET (tylosin)/MGA    Huvepharma EOOD.
                          (melengestrol).
200-533................  TYLOVET (tylosin)/       Huvepharma EOOD.
                          RUMENSIN (monensin)/
                          DECCOX (decoquinate).
200-534................  TYLOVET (tylosin)/       Huvepharma EOOD.
                          RUMENSIN (monensin)/
                          MGA (melengestrol).
200-535................  TYLOVET (tylosin)/       Huvepharma EOOD.
                          BOVATEC (lasalocid)/
                          MGA (melengestrol).
200-544................  TYLOVET (tylosin)/       Huvepharma EOOD.
                          RUMENSIN (monensin)/
                          ZILMAX (zilpaterol)/
                          MGA (melengestrol).
200-547................  TYLOVET (tylosin)/       Huvepharma EOOD.
                          RUMENSIN (monensin)/
                          ZILMAX (zilpaterol).
200-558................  TYLAN (tylosin)/ENGAIN   Zoetis Inc.
                          (ractopamine).
200-561................  TYLAN (tylosin)/         Zoetis Inc.
                          RUMENSIN (monensin)/
                          ACTOGAIN (ractopamine).
200-562................  TYLAN (tylosin)/         Zoetis Inc.
                          RUMENSIN (monensin)/
                          ACTOGAIN (ractopamine).
200-566................  TYLOVET (tylosin)/       Huvepharma EOOD.
                          RUMENSIN (monensin).
200-567................  TYLOVET (tylosin)/       Huvepharma EOOD.
                          RUMENSIN (monensin).

[[Page 94994]]

 
200-583................  TYLOVET (tylosin)/       Zoetis Inc.
                          RUMENSIN (monensin)/
                          ACTOGAIN (ractopamine)/
                          MGA (melengestrol).
200-584................  TYLOVET (tylosin)/       Zoetis Inc.
                          ENGAIN (ractopamine).
200-585................  TYLOVET (tylosin)/       Zoetis Inc.
                          RUMENSIN (monensin)/
                          ACTOGAIN (ractopamine).
------------------------------------------------------------------------

    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 water.

II. Changes of Sponsorship

    Elanco US Inc., 2500 Innovation Way, Greenfield, IN 46140 has 
informed FDA that it has transferred ownership of, and all rights and 
interest in, NADA 141-110, providing for the manufacture of combination 
drug medicated turkey feeds containing STAFAC (virginiamycin) and COBAN 
(monensin) to Phibro Animal Health Corp., GlenPointe Centre East, 3d 
Floor, 300 Frank W. Burr Blvd., Suite 21, Teaneck, NJ 07666. As 
provided in the regulatory text of this document, the animal drug 
regulations are amended to reflect this change of sponsorship.

III. Withdrawals of Approval

    In addition, approval of the following applications for medicated 
feeds containing antimicrobial drugs of importance to human medicine 
administered to food-producing animals is being withdrawn at the 
sponsors' requests because the products are no longer manufactured or 
marketed:

------------------------------------------------------------------------
        File No.               Product name               Sponsor
------------------------------------------------------------------------
034-085................  LINCOMIX (lincomycin     Zoetis Inc., 333
                          hydrochloride            Portage St.,
                          monohydrate) Type A      Kalamazoo, MI 49007
                          Medicated Article.       (Zoetis Inc.).
035-287................  OM-5 Premix              Phibro Animal Health
                          (oleandomycin) Type A    Corp., GlenPointe
                          Medicated Article.       Centre East, 3d
                                                   Floor, 300 Frank W.
                                                   Burr Blvd., Suite 21,
                                                   Teaneck, NJ 07666
                                                   (Phibro Animal Health
                                                   Corp.).
046-668................  Penicillin G Procaine    Phibro Animal Health
                          50% Type A Medicated     Corp.
                          Article.
091-668................  CHLORMAX-SP 500          Zoetis Inc.
                          (chlortetracycline,
                          sulfamethazine,
                          penicillin G procaine)
                          Type A Medicated
                          Article.
108-116................  LINCOMIX (lincomycin)/   Phibro Animal Health
                          NICARB (nicarbazin).     Corp.
133-334................  Virginiamycin Type A     Zoetis Inc.
                          Medicated Article.
139-473................  STAFAC (virginiamycin)/  Huvepharma EOOD, 5th
                          STENEROL (halofuginone   Floor, 3A Nikolay
                          hydrobromide).           Haytov Str., 1113
                                                   Sophia, Bulgaria
                                                   (Huvepharma EOOD).
140-340................  LINCOMIX (lincomycin)/   Huvepharma EOOD.
                          STENOROL (halofuginone
                          hydrobromide).
140-443................  HYGROMIX 1.6             Zoetis Inc.
                          (hygromycin B) Type A
                          Medicated Article.
140-947................  LINCOMIX (lincomycin)/   Elanco US Inc., 2500
                          MAXIBAN (narasin and     Innovation Way,
                          nicarbazin).             Greenfield, IN 46140
                                                   (Elanco US Inc.).
141-090................  STAFAC (virginiamycin)/  Huvepharma EOOD.
                          CLINICOX (diclazuril).
200-171................  LINCOMIX (lincomycin)/   Planalquimica
                          NICARMIX (nicarbazin).   Industrial Ltda., Rua
                                                   das Magnolias nr.
                                                   2405, Jardim das
                                                   Bandeiras, CEP 13053-
                                                   120, Campinas, Sao
                                                   Paulo, Brazil.
200-569................  TYLAN (tylosin)/SACOX    Huvepharma EOOD.
                          (salinomycin).
200-570................  TYLOVET 100 (tylosin)/   Huvepharma EOOD.
                          BIO-COX (salinomycin).
200-580................  TYLOVET 100 (tylosin)/   Huvepharma EOOD.
                          SACOX (salinomycin).
------------------------------------------------------------------------

    Elsewhere in this issue of the Federal Register, FDA gave notice 
that approval of NADAs 034-085, 035-287, 046-668, 091-668, 108-116, 
133-334, 139-473, 140-340, 140-443, 140-947, and 141-090, and ANADAs 
200-171, 200-569, 200-570, and 200-580, and all supplements and 
amendments thereto, is withdrawn, effective January 6, 2017. As 
provided in the regulatory text of this document, the animal drug 
regulations are amended to reflect these voluntary withdrawals of 
approval.
    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

21 CFR Part 556

    Animal drugs, Foods.

21 CFR Part 558

    Animal drugs, Animal feeds.

    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 556 and 
558 are amended as follows:

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

0
1. The authority citation for part 556 continues to read as follows:

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


Sec.  556.480  [Removed]

0
2. Remove Sec.  556.480.

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

0
3. The authority citation for part 558 continues to read as follows:

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


[[Page 94995]]



0
4. In Sec.  558.4, in paragraph (d), in the Category I table, in the 
column headings for ``Assay limits \1\ percent type A'' and ``Assay 
limits percent \1\ type B/C \2\'', remove ``type'' and in its place add 
``Type'', and remove the row entries for ``Erythromycin (thiocyanate 
salt)'' and ``Oleandomycin''; and in the Category II table, 
alphabetically add an entry for ``Erythromycin'' to read as follows:


Sec.  558.4  Requirement of a medicated feed mill license.

* * * * *
    (d) * * *

                                                   Category II
----------------------------------------------------------------------------------------------------------------
                                              Assay limits                                         Assay limits
                    Drug                       percent \1\          Type B maximum (100x)           percent \1\
                                                 Type A                                            Type B/C \2\
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
Erythromycin...............................          85-115  4.625 g/lb (1.02%).................          75-125
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *

0
5. In Sec.  558.58, remove and reserve paragraphs (e)(2), (7), and (8); 
remove paragraphs (e)(10) and (11); and add paragraph (f) to read as 
follows:


Sec.  558.58  Amprolium and ethopabate.

* * * * *
    (f) Amprolium and ethopabate may also be used in combination with:
    (1) [Reserved]
    (2) [Reserved]
    (3) Chlortetracycline as in Sec.  558.128.
    (4) Lincomycin as in Sec.  558.325.
    (5) Virginiamycin as in Sec.  558.635.

0
6. Revise Sec.  558.59 to read as follows:

Sec.  558.59  Apramycin.

    (a) Specifications. Type A articles containing 75 grams apramycin 
(as apramycin sulfate) per pound.
    (b) Sponsor. See No. 058198 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec.  556.52 of this chapter.
    (d) Conditions of use in swine--

----------------------------------------------------------------------------------------------------------------
                                   Combination in
       Apramycin grams/ton            grams/ton       Indications for use           Limitations         Sponsor
----------------------------------------------------------------------------------------------------------------
(1) 150..........................  ..............  For control of porcine    Feed as the sole ration      058198
                                                    colibacillosis            for 14 consecutive
                                                    (weanling pig scours)     days. Withdraw 28 days
                                                    caused by susceptible     before slaughter.
                                                    strains of Escherichia
                                                    coli.
(2) [Reserved]...................
----------------------------------------------------------------------------------------------------------------


0
7. In Sec.  558.76, redesignate paragraphs (e)(2)(iii) through (xvi) as 
paragraphs (e)(2)(iv) through (xvii); and add new paragraph (e)(2)(iii) 
to read as follows:


Sec.  558.76  Bacitracin methylenedisalicylate.

* * * * *
    (e) * * *
    (2) * * *
    (iii) Chlortetracycline as in Sec.  558.128.
* * * * *

0
8. Revise Sec.  558.128 to read as follows:


Sec.  558.128  Chlortetracycline.

    (a) Specifications. Type A medicated articles containing either 
chlortetracycline calcium complex equivalent to chlortetracycline 
hydrochloride, or for products intended for use in milk replacer, 
chlortetracycline hydrochloride.
    (b) Approvals. See sponsors in Sec.  510.600(c) of this chapter for 
use as in paragraph (e) of this section.
    (1) Nos. 054771: 50, 65, or 100 grams per pound (g/lb) Type A 
medicated article.
    (2) No. 066104: 10, 20, 30, 50, 70, or 100 g/lb of Type A medicated 
article.
    (3) No. 069254: 50, 90, or 100 g/lb of Type A medicated article.
    (c) Related tolerances. See Sec.  556.150 of this chapter.
    (d) Special considerations--(1) Federal law restricts medicated 
feed containing this veterinary feed directive (VFD) drug to use by or 
on the order of a licensed veterinarian. See Sec.  558.6 for additional 
requirements.
    (2) The expiration date of VFDs for chlortetracycline medicated 
feeds must not exceed 6 months from the date of issuance. VFDs for 
chlortetracycline shall not be refilled.
    (3) In milk replacers or starter feed; include on labeling the 
warning: ``A withdrawal period has not been established for this 
product in preruminating calves. Do not use in calves to be processed 
for veal.''
    (4) Manufacture for use in free-choice feeds as in paragraph 
(e)(4)(iii) of this section must conform to Sec.  510.455 of this 
chapter.
    (5) When manufactured for use as in paragraph (e)(5)(iii) of this 
section, include on labeling the warning: ``Psittacosis, avian 
chlamydiosis, or ornithosis is a reportable communicable disease, 
transmissible between wild and domestic birds, other animals, and man. 
Contact appropriate public health and regulatory officials.''
    (e) Conditions of use--(1) Chickens. It is used as follows:

----------------------------------------------------------------------------------------------------------------
                               Combination in
  Chlortetracycline amount        grams/ton        Indications for use          Limitations           Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 100 to 200 g/ton.......  ..................  Chickens: For control    Feed continuously for    054771 066104
                                                  of infectious            7 to 14 days. Do not           069254
                                                  synovitis caused by      feed to chickens
                                                  Mycoplasma synoviae      producing eggs for
                                                  susceptible to           human consumption.
                                                  chlortetracycline.

[[Page 94996]]

 
(ii) 100 to 200 g/ton......  Clopidol, 113.5...  Broiler and replacement  Feed continuously as            016592
                                                  chickens: As an aid in   the sole ration from
                                                  the prevention of        the time chicks are
                                                  coccidiosis caused by    placed in floor pens
                                                  Eimeria tenella, E.      for 7 to 14 days. Do
                                                  necatrix, E.             not feed to chickens
                                                  acervulina, E. maxima,   over 16 weeks of age.
                                                  E. mivati, and E.        Do not feed to
                                                  brunetti; and for        chickens producing
                                                  control of infectious    eggs for human
                                                  synovitis caused by M.   consumption.
                                                  synoviae susceptible     Chlortetracycline as
                                                  to chlortetracycline.    provided by No.
                                                                           054771; clopidol as
                                                                           provided by No.
                                                                           016592 in Sec.
                                                                           510.600(c) of this
                                                                           chapter.
(iii) 100 to 200 g/ton.....  Decoquinate, 27.2.  Chickens: For            Feed continuously for           054771
                                                  prevention of            7 to 14 days.
                                                  coccidiosis caused by    Bentonite should not
                                                  Eimeria tenella, E.      be used in
                                                  necatrix, E. mivati,     decoquinate feeds. Do
                                                  E. acervulina, E.        not feed to chickens
                                                  maxima, and E.           producing eggs for
                                                  brunetti; and for        human consumption.
                                                  control of infectious   Chlortetracycline and
                                                  synovitis caused by M,   decoquinate as
                                                  synoviae susceptible     provided by No.
                                                  to chlortetracycline.    054771 in Sec.
                                                                           510.600(c) of this
                                                                           chapter.
(iv) 100 g/ton.............  Robenidine, 30....  Broiler and fryer        Feed continuously as            054771
                                                  chickens: As an aid in   sole ration. Do not
                                                  the prevention of        use this product in
                                                  coccidiosis caused by    feeds conta.
                                                  E. mivati, E.           Chlortetracycline and
                                                  brunetti, E. tenella,    robenidine as
                                                  E. acervulina, E.        provided by No.
                                                  maxima, and E.           054771 in Sec.
                                                  necatrix; as an aid in   510.600(c) of this
                                                  the control of chronic   chapter.
                                                  respiratory disease
                                                  (CRD) caused by
                                                  Mycoplasma
                                                  gallisepticum
                                                  susceptible to
                                                  chlortetracycline; and
                                                  as an aid in the
                                                  control of infectious
                                                  synovitis caused by M.
                                                  synoviae susceptible
                                                  to chlortetracycline.
(v) 200 to 400 g/ton.......  ..................  Chickens: For the        Feed continuously for    054771 066104
                                                  control of chronic       7 to 14 days. Do not           069254
                                                  respiratory disease      feed to chickens
                                                  (CRD) and air sac        producing eggs for
                                                  infection caused by M.   human consumption.
                                                  gallisepticum and
                                                  Escherichia coli
                                                  susceptible to
                                                  chlortetracycline.
(vi) 200 g/ton.............  Amprolium, 227 and  For chickens where       Use in low calcium              054771
                              ethopabate, 3.6.    immunity to              feed containing 0.8%
                                                  coccidiosis is not       dietary calcium and
                                                  desired: For             1.5% sodium sulfate;
                                                  prevention of            feed continuously as
                                                  coccidiosis; and for     sole ration for 7 to
                                                  treatment of chronic     14 days; do not feed
                                                  respiratory disease      to chickens producing
                                                  (CRD) caused by M.       eggs for human
                                                  gallisepticum            consumption.
                                                  susceptible to           Chlortetracycline as
                                                  chlortetracycline.       provided by No.
                                                                           054771; amprolium and
                                                                           ethopabate as
                                                                           provided by No.
                                                                           016592 in Sec.
                                                                           510.600(c) of this
                                                                           chapter.
(vii) 200 g/ton............  Decoquinate, 27.2.  Broilers: As an aid in   Feed continuously as            054771
                                                  the prevention of        the sole ration for
                                                  coccidiosis caused by    no more than 8 weeks.
                                                  Eimeria tenella, E.      Use in low calcium
                                                  necatrix, E.             feed containing 0.8%
                                                  acervulina, E. mivati,   dietary calcium.
                                                  E. maxima, and E.        Bentonite should not
                                                  brunetti; and for the    be used in
                                                  treatment of chronic     decoquinate feeds. Do
                                                  respiratory disease      not feed to chickens
                                                  (air sac infection)      producing eggs for
                                                  and the prevention of    human consumption.
                                                  synovitis.              Chlortetracycline and
                                                                           decoquinate as
                                                                           provided by No.
                                                                           054771 in Sec.
                                                                           510.600(c) of this
                                                                           chapter.
(viii) 200 g/ton...........  Robenidine 30.....  Broiler and fryer        Feed continuously as            054771
                                                  chickens: As an aid in   sole ration. Do not
                                                  the prevention of        use this product in
                                                  coccidiosis caused by    feeds containing
                                                  E. mivati, E.            bentonite. Do not
                                                  brunetti, E. tenella,    feed to chickens
                                                  E. acervulina, E.        producing eggs for
                                                  maxima, and E.           human consumption.
                                                  necatrix; as an aid in   Withdraw 5 days prior
                                                  the control of chronic   to slaughter.
                                                  respiratory disease     Chlortetracycline and
                                                  (CRD) caused by M.       robenidine as
                                                  gallisepticum            provided by No.
                                                  susceptible to           054771 in Sec.
                                                  chlortetracycline; and   510.600(c) of this
                                                  as an aid in the         chapter.
                                                  control of infectious
                                                  synovitis caused by M.
                                                  synoviae susceptible
                                                  to chlortetracycline.
(ix) 500 g/ton.............  ..................  Chickens: For the        1. Feed for 5 days. To   054771 069254
                                                  reduction of mortality   sponsor No. 054771
                                                  due to E. coli           under NADA 048-761
                                                  infections susceptible   and No. 069254 under
                                                  to chlortetracycline.    ANADA 200-510: zero
                                                                           withdrawal time.
                                                                          2. Feed for 5 days;             054771
                                                                           withdraw 24 hours              066104
                                                                           prior to slaughter.            069254
                                                                           Do not feed to
                                                                           chickens producing
                                                                           eggs for human
                                                                           consumption.

[[Page 94997]]

 
(x) 500 g/ton..............  Monensin, 90 to     Chickens: As an aid in   Feed for 5 days as the   054771 069254
                              110.                the reduction of         sole ration. Do not
                                                  mortality due to E.      feed to laying
                                                  coli infections          chickens. Not to be
                                                  susceptible to           fed continuously for
                                                  chlortetracycline; and   more than 5 days. Do
                                                  as an aid in the         not feed to chickens
                                                  prevention of            over 16 weeks of age.
                                                  coccidiosis caused by    Withdraw 24 hours
                                                  Eimeria tenella, E.      before slaughter. See
                                                  necatrix, E.             Sec.   558.355(d) of
                                                  acervulina, E. maxima,   this chapter.
                                                  E. brunetti, and E.      Chlortetracycline as
                                                  mivati.                  provided by No.
                                                                           054771; monensin as
                                                                           provided by No.
                                                                           058198 in Sec.
                                                                           510.600(c) of this
                                                                           chapter.
(xi) 500 g/ton.............  Robenidine, 30....  Broiler and fryer        Feed continuously as            054771
                                                  chickens: As an aid in   sole ration for up to
                                                  the prevention of        5 days. Do not use
                                                  coccidiosis caused by    this product in feeds
                                                  Eimeria mivati, E.       containing bentonite.
                                                  brunetti, E. tenella,    Do not feed to
                                                  E. acervulina, E.        chickens producing
                                                  maxima, and E.           eggs for human
                                                  necatrix; as an aid in   consumption. Withdraw
                                                  the reduction of         5 days prior to
                                                  mortality due to E.      slaughter.
                                                  coli susceptible to     Chlortetracycline and
                                                  chlortetracycline.       robenidine as
                                                                           provided by No.
                                                                           054771 in Sec.
                                                                           510.600(c) of this
                                                                           chapter.
(xii) 500 g/ton............  Salinomycin, 40 to  Broiler chickens: As an  For use in low calcium   016592 054771
                              60.                 aid in the prevention    feeds containing 0.8%          069254
                                                  of coccidiosis caused    calcium. Not approved
                                                  by Eimeria tenella, E.   for use with pellet
                                                  necatrix, E.             binders. Not to be
                                                  acervulina, E. maxima,   fed continuously for
                                                  E. brunetti, and E.      more than 5 days. Do
                                                  mivati; and as an aid    not feed to laying
                                                  in the reduction of      chickens producing
                                                  mortality due to E.      eggs for human
                                                  coli susceptible to      consumption. Withdraw
                                                  chlortetracycline.       24 hours before
                                                                           slaughter. May be
                                                                           fatal if accidentally
                                                                           fed to adult turkeys
                                                                           or horses.
                                                                           Chlortetracycline as
                                                                           provided by Nos.
                                                                           054771 or 069254;
                                                                           salinomycin as
                                                                           provided by Nos.
                                                                           054771 or 016592 in
                                                                           Sec.   510.600(c) of
                                                                           this chapter.
----------------------------------------------------------------------------------------------------------------

    (2) Turkeys. It is used as follows:

----------------------------------------------------------------------------------------------------------------
                               Combination in
  Chlortetracycline amount        grams/ton        Indications for use          Limitations           Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 200 g/ton..............  ..................  Turkeys: For control of  Feed continuously for           054771
                                                  infectious synovitis     7 to 14 days. Do not           066104
                                                  caused by M. synoviae    feed to turkeys                069254
                                                  susceptible to           producing eggs for
                                                  chlortetracycline.       human consumption.
(ii) 400 g/ton.............  ..................  1. Turkeys: For control  Feed continuously for           054771
                                                  of hexamitiasis caused   7 to 14 days. Do not           066104
                                                  by Hexamita              feed to turkeys                069254
                                                  meleagridis              producing eggs for
                                                  susceptible to           human consumption.
                                                  chlortetracycline.
                             ..................  2. Turkey poults not     ......................          054771
                                                  over 4 weeks of age:                                    066104
                                                  For reduction of                                        069254
                                                  mortality due to
                                                  paratyphoid caused by
                                                  Salmonella typhimurium
                                                  susceptible to
                                                  chlortetracycline.
(iii) 25 mg/lb of body       ..................  Turkeys: For control of  Feed continuously for           054771
 weight.                                          complicating bacterial   7 to 14 days. Do not           066104
                                                  organisms associated     feed to turkeys                069254
                                                  with bluecomb            producing eggs for
                                                  (transmissible           human consumption.
                                                  enteritis; coronaviral
                                                  enteritis) susceptible
                                                  to chlortetracycline.
----------------------------------------------------------------------------------------------------------------

    (3) Swine. It is used as follows:

----------------------------------------------------------------------------------------------------------------
                               Combination in
  Chlortetracycline amount        grams/ton        Indications for use          Limitations           Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 50 to 100 g/ton........  ..................  Swine: For reducing the  ......................          054771
                                                  incidence of cervical                                   066104
                                                  lymphadenitis (jowl                                     069254
                                                  abscesses) caused by
                                                  Group E Streptococci
                                                  susceptible to
                                                  chlortetracycline.

[[Page 94998]]

 
(ii) 400 g/ton.............  ..................  Breeding swine: For the  Feed continuously for           054771
                                                  control of               not more than 14 days.         066104
                                                  leptospirosis                                           069254
                                                  (reducing the
                                                  incidence of abortion
                                                  and shedding of
                                                  leptospirae) caused by
                                                  Leptospira pomona
                                                  susceptible to
                                                  chlortetracycline.
(iii) 10 mg/lb of body       ..................  Swine: For treatment of  Feed approximately 400          054771
 weight.                                          bacterial enteritis      g/ton, varying with            066104
                                                  caused by Escherichia    body weight and feed           069254
                                                  coli and S.              consumption to
                                                  choleraesuis and         provide 10 mg/lb per
                                                  bacterial pneumonia      day. Feed for not
                                                  caused by Pasteurella    more than 14 days.
                                                  multocida susceptible    Withdraw 5 d prior to
                                                  to chlortetracycline;    slaughter for sponsor
                                                  for the control of       No. 069254 in Sec.
                                                  porcine proliferative    510.600(c) of this
                                                  enteropathies            chapter.
                                                  (ileitis) caused by
                                                  Lawsonia
                                                  intracellularis
                                                  susceptible to
                                                  chlortetracycline.
(iv) 10 mg/lb of body        Bacitracin          Swine: For treatment of  Feed approximately 400          054771
 weight.                      methylenedisalicy   bacterial enteritis      g/ton, varying with
                              late, 10 to 30.     caused by E. coli and    body weight and feed
                                                  S. choleraesuis and      consumption to
                                                  bacterial pneumonia      provide 10 mg/lb per
                                                  caused by P. multocida   day. Feed for not
                                                  susceptible to           more than 14 days.
                                                  chlortetracycline; for
                                                  the control of porcine
                                                  proliferative
                                                  enteropathies
                                                  (ileitis) caused by
                                                  Lawsonia
                                                  intracellularis
                                                  susceptible to
                                                  chlortetracycline; and
                                                  for increased rate of
                                                  weight gain and
                                                  improved feed
                                                  efficiency.
(v) 10 mg/lb of body weight  Bacitracin          Swine: For treatment of  Feed chlortetracycline          069254
                              methylenedisalicy   bacterial enteritis      at approximately 400
                              late, 10 to 30.     caused by E. coli and    g/ton of feed,
                                                  S. choleraesuis and      varying with body
                                                  bacterial pneumonia      weight and food
                                                  caused by P. multocida   consumption, to
                                                  susceptible to           provide 10 mg/lb of
                                                  chlortetracycline; and   body weight. Feed for
                                                  for increased rate of    not more than 14
                                                  weight gain and          days. Withdraw 5 d
                                                  improved feed            prior to slaughter
                                                  efficiency.              for sponsor No.
                                                                           069254. Bacitracin
                                                                           methylenedisalicylate
                                                                           provided by No.
                                                                           054771;
                                                                           chlortetracycline
                                                                           provided by Nos.
                                                                           054771 and 069254 in
                                                                           Sec.   510.600(c) of
                                                                           this chapter.
(vi) 500 to 4,000 to         Tiamulin hydrogen   For control of swine     Feed continuously as            058198
 provide 10 mg/lb of body     fumarate, 35.       dysentery associated     the sole ration for            069254
 weight daily.                                    with Brachyspira         14 days. Withdraw
                                                  (formerly Serpulina or   medicated feed 2 days
                                                  Treponema)               before slaughter.
                                                  hyodysenteriae           Tiamulin as provided
                                                  susceptible to           by Nos. 058198 or
                                                  tiamulin and for         069254in Sec.
                                                  treatment of swine       510.600(c) of this
                                                  bacterial enteritis      chapter.
                                                  caused by E. coli and
                                                  Salmonella
                                                  choleraesuis sensitive
                                                  to chlortetracycline
                                                  and treatment of
                                                  bacterial pneumonia
                                                  caused by P. multocida
                                                  sensitive to
                                                  chlortetracycline.
----------------------------------------------------------------------------------------------------------------

    (4) Cattle. It is used as follows:

----------------------------------------------------------------------------------------------------------------
                                  Combination in
   Chlortetracycline amount         grams/ton        Indications for use        Limitations           Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 0.5 mg/lb of body weight    .................  Beef cattle (over 700   Withdraw 48 hours              054771
 daily.                                             lb): For control of     prior to slaughter.           066104
                                                    active infection of     To sponsor Nos.               069254
                                                    anaplasmosis caused     054771 and 069254:
                                                    by Anaplasma            Zero withdrawal time.
                                                    marginale susceptible
                                                    to chlortetracycline.

[[Page 94999]]

 
(ii) 25 to 1,100 to provide     Lasalocid, 30 to   Pasture cattle          Feed continuously on           054771
 0.5 mg/lb of body weight        600.               (slaughter, stocker,    a hand-fed basis 0.5
 daily.                                             feeder cattle, beef     mg chlortetracycline
                                                    replacement heifers)    per lb. body weight
                                                    over 700 pounds: For    per day and not less
                                                    control of active       than 60 mg or more
                                                    infection of            than 300 mg
                                                    anaplasmosis caused     lasalocid per head
                                                    by A. marginale         daily in at least 1
                                                    susceptible to          pound of feed. Daily
                                                    chlortetracycline;      lasalocid intakes in
                                                    and for increased       excess of 200 mg/
                                                    rate of weight gain.    head/day in pasture
                                                                            cattle have not been
                                                                            shown to be more
                                                                            effective than 200
                                                                            mg lasalocid/head/
                                                                            day. Do not allow
                                                                            horses or other
                                                                            equines access to
                                                                            feeds containing
                                                                            lasalocid. No
                                                                            withdrawal period is
                                                                            required. A
                                                                            withdrawal period
                                                                            has not been
                                                                            established for this
                                                                            product in pre-
                                                                            ruminating calves.
                                                                            Do not use in calves
                                                                            to be processed for
                                                                            veal. See Sec.
                                                                            558.311(d) of this
                                                                            chapter. Lasalocid
                                                                            as provided by No.
                                                                            054771 in Sec.
                                                                            510.600(c) of this
                                                                            chapter.
(iii) 0.5 to 2.0 mg/lb of body  .................  Beef cattle and         In free-choice cattle          054771
 weight daily.                                      nonlactating dairy      feeds such as feed
                                                    cattle: As an aid in    blocks or salt-
                                                    the control of active   mineral mixes
                                                    infection of            manufactured from
                                                    anaplsmosis caused by   approved Type A
                                                    A. marginale            articles. See
                                                    susceptible to          paragraph (d)(4) of
                                                    chlortetracycline.      this section.
(iv) 10 mg/lb of body weight    .................  1. Calves, beef and     Feed approximately      054771 066104
 daily.                                             nonlactating dairy      400 g/ton, varying            069254
                                                    cattle: For treatment   with body weight and
                                                    of bacterial            feed consumption to
                                                    enteritis caused by     provide 10 mg/lb per
                                                    Escherichia coli and    day. Treat for not
                                                    bacterial pneumonia     more than 5 days. In
                                                    caused by Pasteurella   feed including milk
                                                    multocida organisms     replacers withdraw
                                                    susceptible to          10 days prior to
                                                    chlortetracycline.      slaughter. To
                                                                            sponsor No. 069254:
                                                                            zero withdrawal
                                                                            time. See paragraph
                                                                            (d)(3) of this
                                                                            section.
                                                   2. Calves (up to 250    See paragraph (d)(3)           054771
                                                    lb): For the            of this section.              066104
                                                    treatment of                                          069254
                                                    bacterial enteritis
                                                    caused by E. coli
                                                    susceptible to
                                                    chlortetracycline.
(v) 10 mg/lb of body weight     Laidlomycin, 5...  Cattle fed in           Feed continuously at           054771
 daily.                                             confinement for         a rate of 30 to 75
                                                    slaughter: For          mg laidlomycin
                                                    treatment of            propionate potassium
                                                    bacterial enteritis     per head per day for
                                                    caused by E. coli and   not more than 5
                                                    bacterial pneumonia     days. A withdrawal
                                                    caused by P.            period has not been
                                                    multocida organisms     established for this
                                                    susceptible to          product in pre-
                                                    chlortetracycline;      ruminating calves.
                                                    and for increased       Do not use in calves
                                                    rate of weight and      to be processed for
                                                    improved feed           veal. See Sec.
                                                    efficiency.             558.305(d) of this
                                                                            chapter. Laidlomycin
                                                                            as provided by No.
                                                                            054771 in Sec.
                                                                            510.600(c) of this
                                                                            chapter.
(vi) 10 mg/lb of body weight    Laidlomycin, 5 to  Cattle fed in           Feed continuously at           054771
 daily.                          10.                confinement for         a rate of 30 to 75
                                                    slaughter: For          mg laidlomycin
                                                    treatment of            propionate potassium
                                                    bacterial enteritis     per head per day for
                                                    caused by E. coli and   not more than 5
                                                    bacterial pneumonia     days. A withdrawal
                                                    caused by P.            period has not been
                                                    multocida organisms     established for this
                                                    susceptible to          product in pre-
                                                    chlortetracycline;      ruminating calves.
                                                    and for improved feed   Do not use in calves
                                                    efficiency.             to be processed for
                                                                            veal. See Sec.
                                                                            558.305(d) of this
                                                                            chapter. Laidlomycin
                                                                            as provided by No.
                                                                            054771 in Sec.
                                                                            510.600(c) of this
                                                                            chapter.
(vii) 500 to 2,000 to provide   Lasalocid, 10 to   Cattle fed in           Feed continuously in           054771
 10 mg/lb of body weight daily.  30.                confinement for         complete feed for
                                                    slaughter: For          not more than 5 days
                                                    treatment of            to provide 10 mg
                                                    bacterial enteritis     chlortetracycline
                                                    caused by E. coli and   per lb. body weight
                                                    bacterial pneumonia     per day and not less
                                                    caused by P.            than 100 mg or more
                                                    multocida organisms     than 360 mg
                                                    susceptible to          lasalocid per head
                                                    chlortetracycline;      per day. Do not
                                                    and for improved feed   allow horses or
                                                    efficiency.             other equines access
                                                                            to feeds containing
                                                                            lasalocid. No
                                                                            withdrawal period is
                                                                            required. A
                                                                            withdrawal period
                                                                            has not been
                                                                            established for this
                                                                            product in pre-
                                                                            ruminating calves.
                                                                            Do not use in calves
                                                                            to be processed for
                                                                            veal. See Sec.
                                                                            558.311(d) of this
                                                                            chapter. Lasalocid
                                                                            as provided by No.
                                                                            054771 in Sec.
                                                                            510.600(c) of this
                                                                            chapter.

[[Page 95000]]

 
(viii) 500 to 1,200 to provide  Lasalocid, 25 to   Cattle fed in           Feed continuously in           054771
 10 mg/lb of body weight daily.  30.                confinement for         complete feed for
                                                    slaughter: For          not more than 5 days
                                                    treatment of            to provide 10 mg
                                                    bacterial enteritis     chlortetracycline
                                                    caused by E. coli and   per lb. body weight
                                                    bacterial pneumonia     per day and not less
                                                    caused by P.            than 250 mg or more
                                                    multocida organisms     than 360 mg
                                                    susceptible to          lasalocid per head
                                                    chlortetracycline;      per day. Do not
                                                    and for increased       allow horses or
                                                    rate of weight gain     other equines access
                                                    and improved feed       to feeds containing
                                                    efficiency.             lasalocid. No
                                                                            withdrawal period is
                                                                            required. A
                                                                            withdrawal period
                                                                            has not been
                                                                            established for this
                                                                            product in pre-
                                                                            ruminating calves.
                                                                            Do not use in calves
                                                                            to be processed for
                                                                            veal. See Sec.
                                                                            558.311(d) of this
                                                                            chapter. Lasalocid
                                                                            as provided by No.
                                                                            054771 in Sec.
                                                                            510.600(c) of this
                                                                            chapter.
(ix) 500 to 4,000 to provide    Lasalocid, 30 to   Pasture cattle          Feed continuously on           054771
 10 mg/lb of body weight daily.  600.               (slaughter, stocker,    a hand-fed basis for
                                                    feeder cattle, dairy    not more than 5 days
                                                    and beef replacement    to provide 10 mg
                                                    heifers): For           chlortetracycline
                                                    treatment of            per lb. body weight
                                                    bacterial enteritis     per day and not less
                                                    caused by E. coli and   than 60 mg or more
                                                    bacterial pneumonia     than 300 mg
                                                    caused by P.            lasalocid per head
                                                    multocida organisms     per day. Daily
                                                    susceptible to          lasalocid intakes in
                                                    chlortetracycline;      excess of 200 mg/
                                                    and for increased       head/day in pasture
                                                    rate of weight gain     cattle have not been
                                                    and improved feed       shown to be more
                                                    efficiency.             effective than 200
                                                                            mg lasalocid/head/
                                                                            day. Do not allow
                                                                            horses or other
                                                                            equines access to
                                                                            feeds containing
                                                                            lasalocid. No
                                                                            withdrawal period is
                                                                            required. A
                                                                            withdrawal period
                                                                            has not been
                                                                            established for this
                                                                            product in pre-
                                                                            ruminating calves.
                                                                            Do not use in calves
                                                                            to be processed for
                                                                            veal. See Sec.
                                                                            558.311(d) of this
                                                                            chapter. Lasalocid
                                                                            as provided by No.
                                                                            054771 in Sec.
                                                                            510.600(c) of this
                                                                            chapter.
(x) 500 to 4,000 g/ton........  .................  Calves, beef and        Feed continuously for          054771
                                                    nonlactating dairy      not more than 5 days          069254
                                                    cattle: For the         to provide 10 mg/lb
                                                    treatment of            body weight per day.
                                                    bacterial enteritis     To sponsor No.
                                                    caused by E. coli and   054771 under NADA
                                                    bacterial pneumonia     046-699: 24-hour
                                                    caused by P.            withdrawal period.
                                                    multocida susceptible   To sponsor No.
                                                    to chlortetracycline.   054771 under NADA
                                                                            048-761 and No.
                                                                            069254 under ANADA
                                                                            200-510: Zero
                                                                            withdrawal period.
(xi) 500 to 4,000.............  Decoquinate, 12.9  Calves, beef and non-   Feed at a rate of 1g           054771
                                 to 90.8.           lactating dairy         chlortetracycline             069254
                                                    cattle: For the         per 100 lb body
                                                    treatment of            weight/day and 22.7
                                                    bacterial enteritis     mg decoquinate per
                                                    caused by E. coli and   100 lb of body
                                                    bacterial pneumonia     weight/day for not
                                                    caused by P.            more than 5 days.
                                                    multocida susceptible   When it is fully
                                                    to chlortetracycline;   consumed, resume
                                                    and for the             feeding 22.7 mg
                                                    prevention of           decoquinate per 100
                                                    coccidiosis caused by   lb of body weight/
                                                    Eimeria bovis and E.    day for a total of
                                                    zuernii.                28 days to prevent
                                                                            coccidiosis.
                                                                            Withdraw 24 hours
                                                                            prior to slaughter.
                                                                            A withdrawal period
                                                                            has not been
                                                                            established for this
                                                                            product in pre-
                                                                            ruminating calves.
                                                                            Do not use in calves
                                                                            to be processed for
                                                                            veal. Do not feed to
                                                                            animals producing
                                                                            milk for food.
                                                                            Decoquinate as
                                                                            provided by No.
                                                                            054771 in Sec.
                                                                            510.600(c) of this
                                                                            chapter.
(xii) 4,000 to 20,000 g/ton...  .................  Calves, beef and        As a top dress,                054771
                                                    nonlactating dairy      varying with body
                                                    cattle: For the         weight and feed
                                                    treatment of            consumption, to
                                                    bacterial enteritis     provide 10 mg/lb per
                                                    caused by E. coli and   day. Treat for not
                                                    bacterial pneumonia     more than 5 days.
                                                    caused by P.            See paragraph (d)(3)
                                                    multocida organisms     of this section.
                                                    susceptible to
                                                    chlortetracycline.

[[Page 95001]]

 
(xiii) 4,000 to 20,000 g/ton..  Decoquinate, 90.8  Calves, beef and non-   Administer as a top            054771
                                 to 535.7.          lactating dairy         dress supplement or
                                                    cattle: For the         mix into the daily
                                                    treatment of            ration to provide
                                                    bacterial enteritis     22.7 mg decoquinate
                                                    caused by E. coli and   per 100 lb of body
                                                    bacterial pneumonia     weight per day and 1
                                                    caused by P.            g chlortetracycline
                                                    multocida susceptible   per 100 lb body
                                                    to chlortetracycline;   weight/day for not
                                                    and for the             more than 5 days.
                                                    prevention of           When it is fully
                                                    coccidiosis caused by   consumed, resume
                                                    E. bovis and E.         feeding 22.7 mg
                                                    zuernii.                decoquinate per 100
                                                                            lb of body weight/
                                                                            day for a total of
                                                                            28 days to prevent
                                                                            coccidiosis.
                                                                            Withdraw 24 hours
                                                                            prior to slaughter.
                                                                            A withdrawal period
                                                                            has not been
                                                                            established for this
                                                                            product in pre-
                                                                            ruminating calves.
                                                                            Do not use in calves
                                                                            to be processed for
                                                                            veal. Do not feed to
                                                                            animals producing
                                                                            milk for food.
                                                                            Decoquinate as
                                                                            provided by No.
                                                                            054771 in Sec.
                                                                            510.600(c) of this
                                                                            chapter.
(xiv) 70 mg/head/day..........  .................  Growing cattle (over    See paragraph (d)(3)           054771
                                                    400 lb): For            of this section.              066104
                                                    reduction of                                          069254
                                                    incidence of liver
                                                    abscesses.
(xv) 350 mg/head/day..........  .................  1. Beef cattle: For     Withdraw 48 h prior     054771 066104
                                                    control of bacterial    to slaughter. To              069254
                                                    pneumonia associated    sponsor No. 054771
                                                    with shipping fever     under NADA 046-699:
                                                    complex caused by       48-hour withdrawal
                                                    Pasteurella spp.        time. To sponsor No.
                                                    susceptible to          054771 under NADA
                                                    chlortetracycline.      048-761 and No.
                                                                            069254 under ANADA
                                                                            200-510: zero
                                                                            withdrawal period.
                                                   2. Beef cattle (under   Withdraw 48 h prior     054771 066104
                                                    700 lb): For control    to slaughter. To              069254
                                                    of active infection     sponsor No. 054771
                                                    of anaplasmosis         under NADA 046-699:
                                                    caused by A.            48-hour withdrawal
                                                    marginale susceptible   time. To sponsor No.
                                                    to chlortetracycline.   054771 under NADA
                                                                            048-761 and No.
                                                                            069254 under ANADA
                                                                            200-510: zero
                                                                            withdrawal time.
(xvi) 350 mg/head/day.........  Laidlomycin, 5...  Cattle fed in           Feed continuously at           054771
                                                    confinement for         a rate of 30 to 75
                                                    slaughter: For          mg laidlomycin
                                                    control of bacterial    propionate potassium
                                                    pneumonia associated    per head per day. A
                                                    with shipping fever     withdrawal period
                                                    complex caused by       has not been
                                                    Pasteurella spp.        established for this
                                                    susceptible to          product in pre-
                                                    chlortetracycline;      ruminating calves.
                                                    and for increased       Do not use in calves
                                                    rate of weight and      to be processed for
                                                    improved feed           veal. See Sec.
                                                    efficiency.             558.305(d) of this
                                                                            chapter. Laidlomycin
                                                                            as provided by No.
                                                                            054771 in Sec.
                                                                            510.600(c) of this
                                                                            chapter.
(xvii) 350 mg/head/day........  Laidlomycin, 5 to  Cattle fed in           Feed continuously at           054771
                                 10.                confinement for         a rate of 30 to 75
                                                    slaughter: For          mg laidlomycin
                                                    control of bacterial    propionate potassium
                                                    pneumonia associated    per head per day. A
                                                    with shipping fever     withdrawal period
                                                    complex caused by       has not been
                                                    Pasteurella spp.        established for this
                                                    susceptible to          product in pre-
                                                    chlortetracycline;      ruminating calves.
                                                    and for improved feed   Do not use in calves
                                                    efficiency.             to be processed for
                                                                            veal. See Sec.
                                                                            558.305(d) of this
                                                                            chapter. Laidlomycin
                                                                            as provided by No.
                                                                            054771 in Sec.
                                                                            510.600(c) of this
                                                                            chapter.
(xviii) 25 to 42.2 g/ton to     Lasalocid, 25 to   Cattle under 700        Feed continuously in           054771
 provide 350 mg/head/day.        30.                pounds fed in           complete feed at a
                                                    confinement for         rate of 350 mg
                                                    slaughter: For          chlortetracycline
                                                    control of active       and not less than
                                                    infection of            250 mg nor more than
                                                    anaplasmosis caused     360 mg lasalocid per
                                                    by A. marginale         head daily. Do not
                                                    susceptible to          allow horses or
                                                    chlortetracycline;      other equines access
                                                    and for increased       to feeds containing
                                                    rate of weight gain     lasalocid. No
                                                    and improved feed       withdrawal period is
                                                    efficiency.             required. A
                                                                            withdrawal period
                                                                            has not been
                                                                            established for this
                                                                            product in pre-
                                                                            ruminating calves.
                                                                            Do not use in calves
                                                                            to be processed for
                                                                            veal. See Sec.
                                                                            558.311(d) of this
                                                                            chapter. Lasalocid
                                                                            as provided by No.
                                                                            054771 in Sec.
                                                                            510.600(c) of this
                                                                            chapter.

[[Page 95002]]

 
(xix) 25 to 42.2 g/ton to       Lasalocid, 25 to   Cattle fed in           Feed continuously in           054771
 provide 350 mg/head/day.        30.                confinement for         complete feed at a
                                                    slaughter: For          rate of 350 mg
                                                    control of bacterial    chlortetracycline
                                                    pneumonia associated    and not less than
                                                    with shipping fever     250 mg nor more than
                                                    complex caused by P.    360 mg lasalocid per
                                                    multocida organisms     head daily. Do not
                                                    susceptible to          allow horses or
                                                    chlortetracycline;      other equines access
                                                    and for increased       to feeds containing
                                                    rate of weight gain     lasalocid. No
                                                    and improved feed       withdrawal period is
                                                    efficiency.             required. A
                                                                            withdrawal period
                                                                            has not been
                                                                            established for this
                                                                            product in pre-
                                                                            ruminating calves.
                                                                            Do not use in calves
                                                                            to be processed for
                                                                            veal. See Sec.
                                                                            558.311(d) of this
                                                                            chapter. Lasalocid
                                                                            as provided by No.
                                                                            054771 in Sec.
                                                                            510.600(c) of this
                                                                            chapter.
(xx) 25 to 100 g/ton to         Lasalocid, 10 to   Cattle under 700        Feed continuously in           054771
 provide 350 mg/head/day.        30.                pounds fed in           complete feed at a
                                                    confinement for         rate of 350 mg
                                                    slaughter: For          chlortetracycline
                                                    control of active       and not less than
                                                    infection of            100 mg nor more than
                                                    anaplasmosis caused     360 mg lasalocid per
                                                    by A. marginale         head daily. Do not
                                                    susceptible to          allow horses or
                                                    chlortetracycline;      other equines access
                                                    and for improved feed   to feeds containing
                                                    efficiency.             lasalocid. No
                                                                            withdrawal period is
                                                                            required. A
                                                                            withdrawal period
                                                                            has not been
                                                                            established for this
                                                                            product in pre-
                                                                            ruminating calves.
                                                                            Do not use in calves
                                                                            to be processed for
                                                                            veal. See Sec.
                                                                            558.311(d) of this
                                                                            chapter. Lasalocid
                                                                            as provided by No.
                                                                            054771 in Sec.
                                                                            510.600(c) of this
                                                                            chapter.
(xxi) 25 to 100 g/ton to        Lasalocid, 10 to   Cattle fed in           Feed continuously in           054771
 provide 350 mg/head/day.        30.                confinement for         complete feed at a
                                                    slaughter: For          rate of 350 mg
                                                    control of bacterial    chlortetracycline
                                                    pneumonia associated    and not less than
                                                    with shipping fever     100 mg nor more than
                                                    complex caused by P.    360 mg lasalocid per
                                                    multocida organisms     head daily. Do not
                                                    susceptible to          allow horses or
                                                    chlortetracycline;      other equines access
                                                    and for improved feed   to feeds containing
                                                    efficiency.             lasalocid. No
                                                                            withdrawal period is
                                                                            required. A
                                                                            withdrawal period
                                                                            has not been
                                                                            established for this
                                                                            product in pre-
                                                                            ruminating calves.
                                                                            Do not use in calves
                                                                            to be processed for
                                                                            veal. See Sec.
                                                                            558.311(d) of this
                                                                            chapter. Lasalocid
                                                                            as provided by No.
                                                                            054771 in Sec.
                                                                            510.600(c) of this
                                                                            chapter.
(xxii) 25 to 700 to provide     Lasalocid, 30 to   Pasture cattle          Feed continuously on           054771
 350 mg/head/day.                600.               (slaughter, stocker,    a hand-fed basis at
                                                    feeder cattle, dairy    a rate of 350 mg
                                                    and beef replacement    chlortetracycline
                                                    heifers): For control   and not less than 60
                                                    of bacterial            mg nor more than 300
                                                    pneumonia associated    mg lasalocid per
                                                    with shipping fever     head per day in at
                                                    complex caused by P.    least 1 pound of
                                                    multocida organisms     feed. Daily
                                                    susceptible to          lasalocid intakes in
                                                    chlortetracycline;      excess of 200 mg/
                                                    and for increased       head/day in pasture
                                                    rate of weight gain.    cattle have not been
                                                                            shown to be more
                                                                            effective than 200
                                                                            mg lasalocid/head/
                                                                            day. Do not allow
                                                                            horses or other
                                                                            equines access to
                                                                            feeds containing
                                                                            lasalocid. No
                                                                            withdrawal period is
                                                                            required. A
                                                                            withdrawal period
                                                                            has not been
                                                                            established for this
                                                                            product in pre-
                                                                            ruminating calves.
                                                                            Do not use in calves
                                                                            to be processed for
                                                                            veal. See Sec.
                                                                            558.311(d) of this
                                                                            chapter. Lasalocid
                                                                            as provided by No.
                                                                            054771 in Sec.
                                                                            510.600(c) of this
                                                                            chapter.

[[Page 95003]]

 
(xxiii) 25 to 700 to provide    Lasalocid, 30 to   Pasture cattle          Feed continuously on           054771
 350 mg/head/day.                600.               (slaughter, stocker,    a hand-fed basis at
                                                    feeder cattle, beef     a rate of 350 mg
                                                    replacement heifers)    chlortetracycline
                                                    under 700 pounds: For   and not less than 60
                                                    control of active       mg nor more than 300
                                                    infection of            mg lasalocid per
                                                    anaplasmosis caused     head per day in at
                                                    by A. marginale         least 1 pound of
                                                    susceptible to          feed. Daily
                                                    chlortetracycline;      lasalocid intakes in
                                                    and for increased       excess of 200 mg/
                                                    rate of weight gain.    head/day in pasture
                                                                            cattle have not been
                                                                            shown to be more
                                                                            effective than 200
                                                                            mg lasalocid/head/
                                                                            day. Do not allow
                                                                            horses or other
                                                                            equines access to
                                                                            feeds containing
                                                                            lasalocid. No
                                                                            withdrawal period is
                                                                            required. A
                                                                            withdrawal period
                                                                            has not been
                                                                            established for this
                                                                            product in pre-
                                                                            ruminating calves.
                                                                            Do not use in calves
                                                                            to be processed for
                                                                            veal. See Sec.
                                                                            558.311(d) of this
                                                                            chapter. Lasalocid
                                                                            as provided by No.
                                                                            054771 in Sec.
                                                                            510.600(c) of this
                                                                            chapter.
(xxiv) 25 to 2,800 to provide   Lasalocid, 30 to   Beef cattle weighing    Hand feed                      054771
 350 mg/head/day.                181.8.             up to 800 pounds: For   continuously at a
                                                    control of bacterial    rate of 350 mg
                                                    pneumonia associated    chlortetracycline
                                                    with shipping fever     and 1 mg lasalocid
                                                    complex caused by       per 2.2 lb. body
                                                    Pasteurella spp.        weight daily to
                                                    susceptible to          cattle with a
                                                    chlortetracycline;      maximum of 360 mg of
                                                    and for the control     lasalocid per head
                                                    of coccidiosis caused   per day. Do not
                                                    by E. bovis and E.      allow horses or
                                                    zuernii.                other equines access
                                                                            to feeds containing
                                                                            lasalocid. No
                                                                            withdrawal period is
                                                                            required. A
                                                                            withdrawal period
                                                                            has not been
                                                                            established for this
                                                                            product in pre-
                                                                            ruminating calves.
                                                                            Do not use in calves
                                                                            to be processed for
                                                                            veal. See Sec.
                                                                            558.311(d) of this
                                                                            chapter. Lasalocid
                                                                            as provided by No.
                                                                            054771 in Sec.
                                                                            510.600(c) of this
                                                                            chapter.
(xxv) 500 to 4,000 to provide   Lasalocid, 30 to   Cattle weighing up to   Hand feed                      054771
 350 mg/head/day.                181.8.             800 pounds: For the     continuously at a
                                                    treatment of            rate of 350 mg
                                                    bacterial enteritis     chlortetracycline
                                                    caused by E. coli and   and 1 mg lasalocid
                                                    bacterial pneumonia     per 2.2 lb. body
                                                    caused by P.            weight daily to
                                                    multocida susceptible   cattle with a
                                                    to chlortetracycline;   maximum of 360 mg of
                                                    and for the control     lasalocid per head
                                                    of coccidiosis caused   per day. Do not
                                                    by E. bovis and E.      allow horses or
                                                    zuernii.                other equines access
                                                                            to feeds containing
                                                                            lasalocid. No
                                                                            withdrawal period is
                                                                            required. A
                                                                            withdrawal period
                                                                            has not been
                                                                            established for this
                                                                            product in pre-
                                                                            ruminating calves.
                                                                            Do not use in calves
                                                                            to be processed for
                                                                            veal. See Sec.
                                                                            558.311(d) of this
                                                                            chapter. Lasalocid
                                                                            as provided by No.
                                                                            054771 in Sec.
                                                                            510.600(c) of this
                                                                            chapter.
----------------------------------------------------------------------------------------------------------------

    (5) Minor species. It is used as follows:

----------------------------------------------------------------------------------------------------------------
     Chlortetracycline amount            Indications for use                Limitations               Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 80 mg/head/day................  Breeding sheep; reducing the   .............................          054771
                                     incidence of (vibrionic)                                             066104
                                     abortion caused by                                                   069254
                                     Campylobacter fetus
                                     infection susceptible to
                                     chlortetracycline.
(ii) 200 to 400 g/ton.............  Ducks: For the control and     Feed in complete ration to             054771
                                     treatment of fowl cholera      provide from 8 to 28 mg/lb
                                     caused by Pasteurella          of body weight per day,
                                     multocida susceptible to       depending upon age and
                                     chlortetracycline.             severity of disease, for not
                                                                    more than 21 days. Do not
                                                                    feed to ducks producing eggs
                                                                    for human consumption.
(iii) 10 mg/g of finished feed      Psittacine birds (cockatoos,   Feed continuously for 45               054771
 daily.                              macaws, and parrots)           days. Each bird should
                                     suspected or known to be       consume daily an amount of
                                     infected with psittacosis      medicated feed equal to one
                                     caused by Chlamydia psittaci   fifth of its body weight.
                                     sensitive to                   See paragraph (d)(5) of this
                                     chlortetracycline.             section.
----------------------------------------------------------------------------------------------------------------


[[Page 95004]]

    (6) It is used as a free-choice, loose mineral Type C feed as 
follows:
    (i) Specifications.

------------------------------------------------------------------------
                                                         International
            Ingredient                   Percent            feed No.
------------------------------------------------------------------------
Dicalcium Phosphate...............              46.20           6-26-335
Sodium Chloride (Salt)............              15.00           6-04-152
Magnesium Oxide...................              10.67           6-02-756
Cottonseed Meal...................              10.00           5-01-625
Trace Mineral/Vitamin Premix \1\..               3.80  .................
Calcium Carbonate.................               3.50           6-01-069
Dried Cane Molasses...............               3.00           4-04-695
Potassium Chloride................               2.00           6-03-755
Mineral Oil.......................               2.00           8-03-123
Iron Oxide........................               0.50           6-02-431
Chlortetracycline Type A medicated               3.33  .................
 article (90 gram/lb).............
------------------------------------------------------------------------
\1\ Content of vitamin and trace mineral premixes may be varied.
  However, they should be comparable to those used for other free-choice
  feeds. Formulation modifications require FDA approval prior to
  marketing. Selenium must comply with 21 CFR 573.920. Ethylenediamine
  dihydroiodide (EDDI) should comply with FDA Compliance Policy Guides
  Sec. 651.100 (CPG 7125.18).

    (ii) Amount. 6,000 grams per ton.
    (iii) Indications for use. Beef and nonlactating dairy cattle: As 
an aid in the control of active infection of anaplasmosis caused by 
Anaplasma marginale susceptible to chlortetracycline.
    (iv) Limitations. Feed continuously on a free-choice basis at a 
rate of 0.5 to 2.0 mg chlortetracycline per pound of body weight per 
day.
    (v) Sponsor. See No. 054771 in Sec.  510.600(c) of this chapter.

0
9. In Sec.  558.140, redesignate paragraph (d) as paragraph (e) and add 
new paragraph (d) to read as follows:


Sec.  558.140  Chlortetracycline and sulfamethazine.

* * * * *
    (d) Special considerations--(1) Federal law restricts medicated 
feed containing this veterinary feed directive (VFD) drug to use by or 
on the order of a licensed veterinarian. See Sec.  558.6 for additional 
requirements.
    (2) The expiration date of VFDs for chlortetracycline and 
sulfamethazine medicated feeds must not exceed 6 months from the date 
of issuance. VFDs for chlortetracycline and sulfamethazine shall not be 
refilled.
* * * * *


Sec.  558.145  [Removed]

0
10. Remove Sec.  558.145.

0
11. In Sec.  558.175, in paragraph (b), remove ``Approvals'' and in its 
place add ``Sponsor''; add paragraph (c); remove and reserve paragraphs 
(d)(5) and (6); and add paragraph (e) to read as follows:


Sec.  558.175  Clopidol.

* * * * *
    (c) Related tolerances. See Sec.  556.160 of this chapter.
* * * * *
    (e) Clopidol may also be used in combination with:
    (1) [Reserved]
    (2) [Reserved]
    (3) Chlortetracycline as in Sec.  558.128.
    (4) Lincomycin as in Sec.  558.325.

0
12. In Sec.  558.195, remove and reserve paragraphs (e)(1)(iv) through 
(vi), (e)(2)(ii), (e)(2)(iv), and (e)(2)(vii); and add paragraph (e)(4) 
to read as follows:


Sec.  558.195  Decoquinate.

* * * * *
    (e) * * *
    (4) Decoquinate may also be used in combination with:
    (i) [Reserved]
    (ii) [Reserved]
    (iii) Chlortetracycline as in Sec.  558.128.
    (iv) Lincomycin as in Sec.  558.325.

0
13. In Sec.  558.198, remove and reserve paragraphs (d)(1)(iv) and (v); 
and add paragraph (d)(3) to read as follows:


Sec.  558.198  Diclazuril.

* * * * *
    (d) * * *
    (3) Diclazuril may also be used in combination with virginiamycin 
as in Sec.  558.635.

0
14. In Sec.  558.248, revise paragraph (a); redesignate paragraph (d) 
as paragraph (e); add new paragraph (d); and revise redesignated 
paragraph (e) to read as follows:


Sec.  558.248  Erythromycin.

    (a) Specifications. Type A medicated articles containing 92.5 grams 
per pound erythromycin (as the thiocyanate salt).
* * * * *
    (d) Special considerations.--(1) Federal law restricts medicated 
feed containing this veterinary feed directive (VFD) drug to use by or 
on the order of a licensed veterinarian. See Sec.  558.6 for additional 
requirements.
    (2) The expiration date of VFDs for erythromycin medicated feeds 
must not exceed 6 months from the date of issuance. VFDs for 
erythromycin shall not be refilled.
    (e) Conditions of use--(1) Chickens--

----------------------------------------------------------------------------------------------------------------
                               Combination in
 Erythromycin in grams/ton        grams/ton        Indications for use          Limitations           Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 92.5...................  ..................  Chickens: As an aid in   Feed for 2 days before          061623
                                                  the prevention of        stress and 3 to 6
                                                  chronic respiratory      days after stress.
                                                  disease during periods   Withdraw 24 hours
                                                  of stress.               before slaughter.
(ii) 92.5..................  ..................  Chickens: As an aid in   Feed for 7 to 14 days.          061623
                                                  the prevention of        Withdraw 24 hours
                                                  infectious coryza.       before slaughter.
(iii) 185..................  ..................  Chickens: As an aid in   Feed for 5 to 8 days.           061623
                                                  the prevention and       Withdraw 48 hours
                                                  reduction of lesions     before slaughter. Do
                                                  and in lowering          not use in birds
                                                  severity of chronic      producing eggs for
                                                  respiratory disease      food.
                                                  (CRD).
----------------------------------------------------------------------------------------------------------------


[[Page 95005]]

    (2) Turkeys--

----------------------------------------------------------------------------------------------------------------
Erythromycin thiocyanate in    Combination in
         grams/ton                grams/ton        Indications for use          Limitations           Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 92.5...................  ..................  Turkeys: As an aid in    Feed for 2 days before          061623
                                                  the prevention of        stress and 3 to 6
                                                  chronic respiratory      days after stress.
                                                  disease during periods
                                                  of stress.
(ii) 185...................  ..................  Turkeys: As an aid in    Feed for 5 to 8 days.           061623
                                                  the prevention and       Do not use in birds
                                                  reduction of lesions     producing eggs for
                                                  and in lowering          food.
                                                  severity of chronic
                                                  respiratory disease
                                                  (CRD).
----------------------------------------------------------------------------------------------------------------


0
15. In Sec.  558.258, remove and reserve paragraphs (e)(2)(ii) through 
(v); and add paragraph (e)(6) to read as follows:


Sec.  558.258  Fenbendazole.

* * * * *
    (e) * * *
    (6) Fenbendazole may also be used in combination with:
    (i) [Reserved]
    (ii) Lincomycin as in Sec.  558.325.

0
16. In Sec.  558.265, remove and reserve paragraphs (d)(1)(iii), 
(d)(1)(iv), and (d)(1)(vii); and add paragraph (d)(4) to read as 
follows:


Sec.  558.265  Halofuginone.

* * * * *
    (d) * * *
    (4) Halofuginone may also be used in combination with:
    (i) [Reserved]
    (ii) Lincomycin as in Sec.  558.325.
    (iii) Virginiamycin as in Sec.  558.635.

0
17. Revise Sec.  558.274 to read as follows:


Sec.  558.274  Hygromycin B.

    (a) Specifications. Type A medicated articles containing 2.4 or 8 
grams hygromycin B per pound (g/lb).
    (b) Sponsor. See No. 058198 in Sec.  510.600(c) of this chapter for 
as follows:
    (c) Related tolerances. See Sec.  556.330 of this chapter.
    (d) Special considerations--(1) Federal law restricts medicated 
feed containing this veterinary feed directive (VFD) drug to use by or 
on the order of a licensed veterinarian. See Sec.  558.6 for additional 
requirements.
    (2) The expiration date of VFDs for hygromycin B medicated feeds 
must not exceed 6 months from the date of issuance. VFDs for hygromycin 
B shall not be refilled.
    (e) Conditions of use. It is used in feed as follows:
    (1) Chickens--

----------------------------------------------------------------------------------------------------------------
                               Combination in
   Hygromycin B grams/ton         grams/ton        Indications for use          Limitations           Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 8 to 12................  ..................  Chickens: For control    Use in complete feed.           058198
                                                  of infections of large   Withdraw 3 days
                                                  roundworms (Ascaris      before slaughter.
                                                  galli), cecal worms
                                                  (Heterakis gallinae),
                                                  and capillary worms
                                                  (Capillaria obsignata).
(ii) [Reserved]
----------------------------------------------------------------------------------------------------------------

    (2) Swine--

----------------------------------------------------------------------------------------------------------------
                               Combination in
   Hygromycin B grams/ton         grams/ton        Indications for use          Limitations           Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 12.....................  ..................  Swine: For control of    In market hogs, use in          058198
                                                  infections of large      complete feed for 8
                                                  roundworms (A. suis),    weeks during the
                                                  nodular worms (O.        growing period.
                                                  dentatum), and           Withdraw 15 days
                                                  whipworms (Trichuris     before slaughter.
                                                  suis).
(ii) [Reserved]
----------------------------------------------------------------------------------------------------------------


0
18. In Sec.  558.300, remove and reserve paragraphs (e)(4) through (7); 
and add paragraph (f) to read as follows:


Sec.  558.300  Ivermectin.

* * * * *
    (f) Ivermectin may also be used in combination with:
    (1) [Reserved]
    (2) Lincomycin as in Sec.  558.325.

0
19. In Sec.  558.305, remove paragraphs (e)(2), (e)(3), (e)(5), and 
(e)(6); redesignate paragraph (e)(4) as new paragraph (e)(2); and add 
paragraph (f) to read as follows:


Sec.  558.305  Laidlomycin.

* * * * *
    (f) Laidlomycin may also be used in combination with 
chlortetracycline as in Sec.  558.128.

0
20. In Sec.  558.311, in paragraph (e)(1)(i), in the row entry for 
``Bambermycins 1 to 2'', in the ``Lasalocid sodium in grams per ton'' 
column, add ``(ii) 68 (0.0075 pct) to 113 (0.0125 pct).''; in 
paragraphs (e)(1)(vi) and (vii), remove the row entries for 
``Oxytetracycline 7.5''; in paragraph (e)(1)(xv), remove the row entry 
for ``Virginiamycin 10 to 20''; remove and reserve paragraphs 
(e)(1)(iii), (e)(1)(v), and (e)(1)(xx) through (e)(1)(xxviii); 
redesignate paragraph (e)(5)(i) as paragraph (e)(5)(ii); and add new 
paragraphs (e)(5)(i) and (e)(5)(iii) to read as follows:


Sec.  558.311  Lasalocid.

* * * * *
    (e) * * *
    (5) * * *
    (i) Chlortetracycline as in Sec.  558.128.
* * * * *
    (iii) Virginiamycin as in Sec.  558.635.

0
21. Revise Sec.  558.325 to read as follows:

[[Page 95006]]

Sec.  558.325  Lincomycin.

    (a) Specifications. Type A medicated articles containing 20 or 50 
grams of lincomycin (as lincomycin hydrochloride) per pound.
    (b) Sponsors. See No. 054771 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec.  556.360 of this chapter.
    (d) Special considerations--(1) Federal law restricts medicated 
feed containing this veterinary feed directive (VFD) drug to use by or 
on the order of a licensed veterinarian. See Sec.  558.6 for additional 
requirements.
    (2) The expiration date of VFDs for chlortetracycline and 
sulfamethazine medicated feeds must not exceed 6 months from the date 
of issuance. VFDs for chlortetracycline and sulfamethazine shall not be 
refilled.
    (3) Labeling of Type A medicated articles and Type B and Type C 
medicated feeds containing lincomycin shall bear the following:
    (i) ``CAUTION: Do not allow rabbits, hamsters, guinea pigs, horses, 
or ruminants access to feeds containing lincomycin. Ingestion by these 
species may result in severe gastrointestinal effects.''
    (4) Labeling of medicated feeds containing lincomycin intended for 
use in swine shall bear the following:
    (i) ``CAUTION: Occasionally, swine fed lincomycin may within the 
first 2 days after the onset of treatment develop diarrhea and/or 
swelling of the anus. On rare occasions, some pigs may show reddening 
of the skin and irritable behavior. These conditions have been self-
correcting within 5 to 8 days without discontinuing the lincomycin 
treatment.''
    (ii) ``CAUTION: The effects of lincomycin on swine reproductive 
performance, pregnancy, and lactation have not been determined.''
    (e) Conditions of use--(1) Chickens--

----------------------------------------------------------------------------------------------------------------
                               Combination in
   Lincomycin  grams/ton          grams/ton        Indications for use          Limitations          Sponsors
----------------------------------------------------------------------------------------------------------------
(i) 2......................  ..................  Broilers: For the        Feed as the sole                054771
                                                  control of necrotic      ration. Not for use
                                                  enteritis caused or      in layers, breeders,
                                                  complicated by           or turkeys.
                                                  Clostridium spp. or
                                                  other organisms
                                                  susceptible to
                                                  lincomycin.
(ii) [Reserved]
----------------------------------------------------------------------------------------------------------------

    (2) Swine--

----------------------------------------------------------------------------------------------------------------
                               Combination in
   Lincomycin  grams/ton          grams/ton        Indications for use          Limitations          Sponsors
----------------------------------------------------------------------------------------------------------------
(i) 40.....................  ..................  For control of swine     Feed as sole ration.            054771
                                                  dysentery and the        For use in swine on
                                                  control of porcine       premises with a
                                                  proliferative            history of swine
                                                  enteropathies            dysentery but where
                                                  (ileitis) caused by      symptoms have not yet
                                                  Lawsonia                 occurred, or
                                                  intracellularis.         following use of
                                                                           lincomycin at 100
                                                                           grams (g)/ton for the
                                                                           treatment of swine
                                                                           dysentery and the
                                                                           control of porcine
                                                                           proliferative
                                                                           enteropathies
                                                                           (ileitis).
(ii) 40....................  Fenbendazole, 10    For control of swine     Feed as sole ration to          000061
                              to 80.              dysentery in animals     provide a total dose
                                                  on premises with a       of 9 mg fenbendazole/
                                                  history of swine         kg of body weight
                                                  dysentery, but where     within 3 to 12 days.
                                                  symptoms have not yet    Do not feed to swine
                                                  occurred; and for the    that weigh more than
                                                  removal of: Adult        250 pounds.
                                                  stage lungworms          Lincomycin as
                                                  (Metastrongylus apri     provided by No.
                                                  and M. pudendotectus);   054771; fenbendazole
                                                  adult and larvae (L3,    as provided by No.
                                                  4 stages--liver, lung,   000061 in Sec.
                                                  intestinal forms)        510.600(c) of this
                                                  large roundworms         chapter.
                                                  (Ascaris suum); adult
                                                  stage nodular worms
                                                  (Oesophagostomum
                                                  dentatum, O.
                                                  quadrispinulatum);
                                                  adult stage small
                                                  stomach worms
                                                  (Hyostrongylus
                                                  rubidus); adult and
                                                  larvae (L2, 3, 4
                                                  stages--intestinal
                                                  mucosal forms)
                                                  whipworms (Trichuris
                                                  suis); adult and
                                                  larvae kidney worms
                                                  (Stephanurus dentatus).

[[Page 95007]]

 
(iii) 40...................  Ivermectin, 1.8...  Weaned, growing and      Feed as the only feed           050604
                                                  finishing swine: For     for 7 consecutive
                                                  control of swine         days to provide 0.1
                                                  dysentery on premises    mg ivermectin/kg of
                                                  with a history of        body weight per day.
                                                  swine dysentery, but     A separate feed
                                                  where symptoms have      containing 40 g/ton
                                                  not yet occurred; and    lincomycin may be
                                                  for treatment and        continued to complete
                                                  control of               the lincomycin
                                                  gastrointestinal         treatment. Not to be
                                                  roundworms (Ascaris      fed to swine that
                                                  suum, adults and         weigh more than 250
                                                  fourth-stage larvae;     lbs. Withdraw 5 days
                                                  Ascarops strongylina,    before slaughter.
                                                  adults; Hyostrongylus    Lincomycin as
                                                  rubidus, adults and      provided by No.
                                                  fourth-stage larvae;     054771; ivermectin as
                                                  Oesophagostomum spp.,    provided by No.
                                                  adults and fourth-       050604 in Sec.
                                                  stage larvae); kidney    510.600(c) of this
                                                  worms (Stephanurus       chapter.
                                                  dentatus, adults and
                                                  fourth-stage larvae);
                                                  lungworms
                                                  (Metastrongylus spp.,
                                                  adults); lice
                                                  (Haematopinus suis);
                                                  and mange mites
                                                  (Sarcoptes scabiei
                                                  var. suis).
(iv) 40....................  Pyrantel, 96......  For control of swine     Feed as the sole                066104
                                                  dysentery on premises    ration. Not to be fed
                                                  with a history of        to swine that weigh
                                                  swine dysentery, but     more than 250 pounds.
                                                  where symptoms have      Withdraw 6 days prior
                                                  not yet occurred; as     to slaughter.
                                                  an aid in the            Lincomycin as
                                                  prevention of            provided by No.
                                                  migration and            054771; pyrantel as
                                                  establishment of large   provided by No.
                                                  roundworm (Ascaris       066104 in Sec.
                                                  suum) infections; and    510.600(c) of this
                                                  as an aid in the         chapter.
                                                  prevention of
                                                  establishment of
                                                  nodular worm
                                                  (Oesophagostomum spp.)
                                                  infections.
(v) 40.....................  Pyrantel, 96......  For the treatment and/   Feed for 3 days as the          066104
                                                  or control of swine      sole ration. Not to
                                                  dysentery; for removal   be fed to swine that
                                                  and control of large     weigh more than 250
                                                  roundworm (Ascaris       pounds. Withdraw 24
                                                  suum) infections.        hours prior to
                                                                           slaughter. Lincomycin
                                                                           as provided by No.
                                                                           054771; pyrantel as
                                                                           provided by No.
                                                                           066104 in Sec.
                                                                           510.600(c) of this
                                                                           chapter.
(vi) 40 or 100.............  Pyrantel, 96......  For the treatment and/   For treatment of swine          066104
                                                  or control of swine      dysentery, feed 100
                                                  dysentery; as an aid     grams of lincomycin
                                                  in the prevention of     and 96 grams of
                                                  migration and            pyrantel tartrate per
                                                  establishment of large   ton of complete feed
                                                  roundworm (Ascaris       for 3 weeks or until
                                                  suum) infections; and    clinical signs of the
                                                  as an aid in the         disease disappear,
                                                  prevention of            following with 40
                                                  establishment of         grams of lincomycin
                                                  nodular worm             and 96 grams of
                                                  (Oesophagostomum spp.)   pyrantel tartrate per
                                                  infections.              ton of complete feed
                                                                           as the sole ration.
                                                                           Not to be fed to
                                                                           swine that weigh more
                                                                           than 250 pounds.
                                                                           Withdraw 6 days prior
                                                                           to slaughter.
                                                                           Lincomycin as
                                                                           provided by No.
                                                                           054771; pyrantel as
                                                                           provided by No.
                                                                           066104 in Sec.
                                                                           510.600(c) of this
                                                                           chapter.
(vii) 100..................  ..................  For treatment of swine   Feed as the sole                054771
                                                  dysentery and the        ration for 3 weeks or
                                                  control of porcine       until clinical signs
                                                  proliferative            of the disease
                                                  enteropathies            disappear.
                                                  (ileitis) caused by
                                                  Lawsonia
                                                  intracellularis.
(viii) 100.................  Fenbendazole, 10    For the treatment of     Feed as sole ration to          000061
                              to 80.              swine dysentery; and     provide a total dose
                                                  for the removal of:      of 9 mg fenbendazole/
                                                  Adult stage lungworms    kg of body weight
                                                  (Metastrongylus apri     within 3 to 12 days.
                                                  and M. pudendotectus);   Do not feed to swine
                                                  adult and larvae (L3,    that weigh more than
                                                  4 stages--liver, lung,   250 pounds. Do not
                                                  intestinal forms)        use within 6 days of
                                                  large roundworms         slaughter. Lincomycin
                                                  (Ascaris suum); adult    as provided by No.
                                                  stage nodular worms      054771; fenbendazole
                                                  (Oesophagostomum         as provided by No.
                                                  dentatum, O.             000061 in Sec.
                                                  quadrispinulatum);       510.600(c) of this
                                                  adult stage small        chapter.
                                                  stomach worms
                                                  (Hyostrongylus
                                                  rubidus); adult and
                                                  larvae (L2, 3, 4
                                                  stages--intestinal
                                                  mucosal forms)
                                                  whipworms (Trichuris
                                                  suis); adult and
                                                  larvae kidney worms
                                                  (Stephanurus dentatus).

[[Page 95008]]

 
(ix) 100...................  Ivermectin, 1.8...  Weaned, growing and      Feed as the only feed           050604
                                                  finishing swine: For     for 7 consecutive
                                                  the treatment of swine   days to provide 0.1
                                                  dysentery; and for       mg ivermectin/kg of
                                                  treatment and control    body weight per day.
                                                  of gastrointestinal      A separate feed
                                                  roundworms (Ascaris      containing 100 g/ton
                                                  suum, adults and         lincomycin may be
                                                  fourth-stage larvae;     continued to complete
                                                  Ascarops strongylina,    the lincomycin
                                                  adults; Hyostrongylus    treatment. Not to be
                                                  rubidus, adults and      fed to swine that
                                                  fourth-stage larvae;     weigh more than 250
                                                  Oesophagostomum spp.,    lbs. Withdraw 6 days
                                                  adults and fourth-       before slaughter.
                                                  stage larvae);           Lincomycin as
                                                  kidneyworms              provided by No.
                                                  (Stephanurus dentatus,   054771; ivermectin as
                                                  adults and fourth-       provided by No.
                                                  stage larvae);           050604 in Sec.
                                                  lungworms                510.600(c) of this
                                                  (Metastrongylus spp.,    chapter.
                                                  adults); lice
                                                  (Haematopinus suis);
                                                  and mange mites
                                                  (Sarcoptes scabiei
                                                  var. suis).
(x) 100....................  Pyrantel, 96......  For the treatment of     Feed as the sole                066104
                                                  swine dysentery; as an   ration for 3 weeks or
                                                  aid in the prevention    until clinical signs
                                                  of migration and         of the disease
                                                  establishment of large   disappear. Not to be
                                                  roundworm (Ascaris       fed to swine that
                                                  suum) infections; and    weigh more than 250
                                                  as an aid in the         pounds. Withdraw 6
                                                  prevention of            days prior to
                                                  establishment of         slaughter. Lincomycin
                                                  nodular worm             as provided by No.
                                                  (Oesophagostomum spp.)   054771; pyrantel as
                                                  infections.              provided by No.
                                                                           066104 in Sec.
                                                                           510.600(c) of this
                                                                           chapter.
(xi) 100...................  Pyrantel, 96......  For the treatment and/   Feed for 3 days as the          066104
                                                  or control of swine      sole ration. Not to
                                                  dysentery; for removal   be fed to swine that
                                                  and control of large     weigh more than 250
                                                  roundworm (Ascaris       pounds. Withdraw 24
                                                  suum) infections.        hours prior to
                                                                           slaughter. Lincomycin
                                                                           as provided by No.
                                                                           054771; pyrantel as
                                                                           provided by No.
                                                                           066104 in Sec.
                                                                           510.600(c) of this
                                                                           chapter.
(xii) 100..................  Pyrantel, 800.....  For the treatment and/   Feed as a single                066104
                                                  or control of swine      therapeutic
                                                  dysentery; for removal   treatment. Not to be
                                                  and control of large     fed to swine that
                                                  roundworm (Ascaris       weigh more than 250
                                                  suum) and nodular worm   pounds. Withdraw 24
                                                  (Oesophagostomum spp.)   hours prior to
                                                  infections.              slaughter. Lincomycin
                                                                           as provided by No.
                                                                           054771; pyrantel as
                                                                           provided by No.
                                                                           066104 in Sec.
                                                                           510.600(c) of this
                                                                           chapter.
(xiii) 200.................  ..................  For reduction in the     Feed as sole ration             054771
                                                  severity of swine        for 21 days.
                                                  mycoplasmal pneumonia
                                                  caused by Mycoplasma
                                                  hyopneumoniae.
(xiv) 200..................  Fenbendazole, 10    For reduction in the     Feed as sole ration to          000061
                              to 80.              severity of swine        provide a total dose
                                                  mycoplasmal pneumonia    of 9 mg fenbendazole/
                                                  caused by Mycoplasma     kg of body weight
                                                  hyopneumoniae; and for   within 3 to 12 days.
                                                  the removal of: Adult    Do not feed to swine
                                                  stage lungworms          that weigh more than
                                                  (Metastrongylus apri     250 pounds. Do not
                                                  and M. pudendotectus);   use within 6 days of
                                                  adult and larvae (L3,    slaughter. Lincomycin
                                                  4 stages--liver, lung,   as provided by No.
                                                  intestinal forms)        054771; fenbendazole
                                                  large roundworms         as provided by No.
                                                  (Ascaris suum); adult    000061 in Sec.
                                                  stage nodular worms      510.600(c) of this
                                                  (Oesophagostomum         chapter.
                                                  dentatum, O.
                                                  quadrispinulatum);
                                                  adult stage small
                                                  stomach worms
                                                  (Hyostrongylus
                                                  rubidus); adult and
                                                  larvae (L2, 3, 4
                                                  stages--intestinal
                                                  mucosal forms)
                                                  whipworms (Trichuris
                                                  suis); adult and
                                                  larvae kidney worms
                                                  (Stephanurus dentatus).

[[Page 95009]]

 
(xv) 200...................  Ivermectin, 1.8...  For reduction in the     Feed as the only feed           050604
                                                  severity of swine        for 7 consecutive
                                                  mycoplasmal pneumonia    days to provide 0.1
                                                  caused by Mycoplasma     mg ivermectin/kg of
                                                  hyopneumoniae; and for   body weight per day.
                                                  treatment and control    A separate feed
                                                  of gastrointestinal      containing 200 g/ton
                                                  roundworms (Ascaris      lincomycin may be
                                                  suum, adults and         continued for an
                                                  fourth-stage larvae;     additional 14 days to
                                                  Ascarops strongylina,    complete the
                                                  adults; Hyostrongylus    lincomycin treatment.
                                                  rubidus, adults and      Not to be fed to
                                                  fourth-stage larvae;     swine that weigh more
                                                  Oesophagostomum spp.,    than 250 lbs.
                                                  adults and fourth-       Withdraw 6 days
                                                  stage larvae);           before slaughter.
                                                  kidneyworms              Lincomycin as
                                                  (Stephanurus dentatus,   provided by No.
                                                  adults and fourth-       054771; ivermectin as
                                                  stage larvae);           provided by No.
                                                  lungworms                050604 in Sec.
                                                  (Metastrongylus spp.,    510.600(c) of this
                                                  adults); lice            chapter.
                                                  (Haematopinus suis);
                                                  and mange mites
                                                  (Sarcoptes scabiei
                                                  var. suis).
(xvi) 200..................  Pyrantel, 96......  For reduction in the     Feed as the sole                054771
                                                  severity of swine        ration for 21 days.
                                                  mycoplasmal pneumonia    Not for use in swine
                                                  caused by Mycoplasma     that weigh more than
                                                  hyopneumoniae; and as    250 pounds. Withdraw
                                                  an aid in the            6 days before
                                                  prevention of            slaughter. Lincomycin
                                                  migration and            as provided by No.
                                                  establishment of large   054771; pyrantel as
                                                  roundworm (Ascaris       provided by No.
                                                  suum) infections; aid    066104 in Sec.
                                                  in the prevention of     510.600(c) of this
                                                  establishment of         chapter.
                                                  nodular worm
                                                  (Oesophagostomum spp.)
                                                  infections.
----------------------------------------------------------------------------------------------------------------


0
22. In Sec.  558.342, remove and reserve paragraphs (e)(1)(iii), 
(e)(1)(iv), (e)(1)(viii), (e)(1)(ix), and (e)(1)(xi); and revise 
paragraph (e)(2) to read as follows:


Sec.  558.342  Melengestrol.

* * * * *
    (e) * * *
    (2) Melengestrol may also be used in combination with:
    (i) Ractopamine as in Sec.  558.500.
    (ii) Tylosin as in Sec.  558.625.
    (iii) Zilpaterol as in Sec.  558.665.

0
23. In Sec.  558.355, revise paragraphs (a) and (b); remove and reserve 
paragraphs (f)(1)(viii), (f)(1)(ix), (f)(1)(xiii), (f)(1)(xiv), 
(f)(1)(xxi), (f)(1)(xxii), (f)(1)(xxxi), (f)(2)(iv), (f)(3)(ii), and 
(f)(3)(xii); and revise paragraph (f)(8) to read as follows:


Sec.  558.355  Monensin.

    (a) Specifications. Type A medicated articles containing 45, 60, 
90.7, or 110 grams monensin, USP, per pound.
    (b) Approvals. See sponsor numbers in Sec.  510.600(c) of this 
chapter for conditions of use as in paragraph (f) of this section:
    (1) No. 058198 for use as in paragraph (f) of this section.
    (2) No. 054771 for use as in paragraphs (f)(1)(xxiv) and (xxv) of 
this section.
    (3) No. 058198 for use as in paragraphs (f)(1)(i), (iii), (iv), and 
(v) of this section.
* * * * *
    (f) * * *
    (8) Monensin may also be used in combination with:
    (i) Chlortetracycline as in Sec.  558.128.
    (ii) Decoquinate as in Sec.  558.195.
    (iii) Lincomycin as in Sec.  558.325.
    (iv) Melengestrol acetate as in Sec.  558.342.
    (v) Oxytetracycline as in Sec.  558.128.
    (vi) Ractopamine alone or in combination as in Sec.  558.500.
    (vii) Tilmicosin as in Sec.  558.618.
    (viii) Tylosin as in Sec.  558.625.
    (ix) Virginiamycin as in Sec.  558.635.
    (x) Zilpaterol alone or in combination as in Sec.  558.665.

0
24. In Sec.  558.364, redesignate paragraph (d) as paragraph (e) and 
revise paragraphs (a) through (d) to read as follows:


Sec.  558.364  Neomycin sulfate.

    (a) Specifications. Type A medicated article containing 325 grams 
neomycin sulfate per pound.
    (b) Sponsor. See No. 054771 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec.  556.430 of this chapter.
    (d) Special considerations--(1) Federal law restricts medicated 
feed containing this veterinary feed directive (VFD) drug to use by or 
on the order of a licensed veterinarian. See Sec.  558.6 for additional 
requirements.
    (2) The expiration date of VFDs for neomycin medicated feeds must 
not exceed 6 months from the date of issuance. VFDs for neomycin shall 
not be refilled.
* * * * *

0
25. In Sec.  558.366, in the table in paragraph (d), remove the row 
entries under ``Nicarbazin in grams per ton'' ``27 to 45'' for 
``Narasin 27 to 45 and Lincomycin 2 to 4''; and under ``Nicarbazin in 
grams per ton'' ``113.5 (0.0125 pct)'' for ``Lincomycin 2 (0.00044 
pct)''; and add paragraph (e) to read as follows:


Sec.  558.366  Nicarbazin.

* * * * *
    (e) * * *
    (6) Nicarbazin may also be used in combination with:
    (i) [Reserved]
    (ii) Lincomycin as in Sec.  558.325.


Sec.  558.435  [Removed]

0
26. Remove Sec.  556.435.

0
27. Revise Sec.  558.450 to read as follows:


Sec.  558.450  Oxytetracycline.

    (a) Specifications. Each pound of Type A medicated article 
contains:
    (1) Oxytetracycline (from oxytetracycline quaternary salt) 
equivalent to 50 or 100 grams oxytetracycline hydrochloride; or 
oxytetracycline (from oxytetracycline dihydrate base) equivalent to 10, 
30, 50, 100, or 200 grams oxytetracycline hydrochloride.
    (2) Oxytetracycline (from oxytetracycline dihydrate base) 
equivalent to 50, 100, or 200 grams oxytetracycline hydrochloride; or 
100 grams oxytetracycline hydrochloride.
    (b) Sponsors. See sponsors in Sec.  510.600(c) of this chapter as 
follows:

[[Page 95010]]

    (1) No. 066104: Type A medicated articles as in paragraph (a)(1) of 
this section.
    (2) No. 069254: Type A medicated articles as in paragraph (a)(2) of 
this section.
    (c) Related tolerances. See Sec.  556.500 of this chapter.
    (d) Special considerations--(1) Federal law restricts medicated 
feed containing this veterinary feed directive (VFD) drug to use by or 
on the order of a licensed veterinarian. See Sec.  558.6 for additional 
requirements.
    (2) The expiration date of VFDs for oxytetracycline medicated feeds 
must not exceed 6 months from the date of issuance. VFDs for 
oxytetracycline shall not be refilled.
    (3) In accordance with Sec.  558.5, labeling shall bear the 
statement: ``For use in dry animal feed only. Not for use in liquid 
feed supplements.''
    (e) Conditions of use--(1) Chickens--

----------------------------------------------------------------------------------------------------------------
                               Combination in
   Oxytetracycline amount         grams/ton        Indications for use          Limitations           Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 100 to 200 g/ton.......  ..................  Chickens: For control    Feed continuously for           066104
                                                  of infectious            7 to 14 days. Do not           069254
                                                  synovitis caused by      feed to chickens
                                                  Mycoplasma synoviae      producing eggs for
                                                  and control of fowl      human consumption. Do
                                                  cholera caused by        not use in feed
                                                  Pasteurella multocida    containing less than
                                                  susceptible to           0.55% dietary
                                                  oxytetracycline.         calcium. Use in such
                                                                           low calcium feeds may
                                                                           result in violative
                                                                           residues. Zero-day
                                                                           withdrawal period.
(ii) 200 g/ton.............  Monensin, 90 to     Broiler chickens: As an  Feed continuously as            066104
                              110.                aid in the prevention    the sole ration. Do
                                                  of coccidiosis caused    not feed to laying
                                                  by Eimeria necatrix,     chickens. Do not feed
                                                  E. tenella, E.           to chickens over 16
                                                  acervulina, E.           weeks of age. Do not
                                                  brunetti, E. mivati,     use in feed
                                                  and E. maxima; and for   containing less than
                                                  the control of           0.55% dietary
                                                  complicated chronic      calcium. Use in such
                                                  respiratory disease      low calcium feeds may
                                                  (CRD or air sac          result in violative
                                                  infection) caused by     residues. Withdraw 72
                                                  Mycoplasma               hours before
                                                  gallisepticum and        slaughter. See Sec.
                                                  Escherichia coli.        558.355(d) of this
                                                                           chapter
                                                                           Oxytetracycline as
                                                                           provided by No.
                                                                           066104; monensin as
                                                                           provided by No.
                                                                           058198 in Sec.
                                                                           510.600(c) of this
                                                                           chapter.
(iii) 400 g/ton............  ..................  Chickens: For control    Feed continuously for           066104
                                                  of chronic respiratory   7 to 14 days. Do not           069254
                                                  disease (CRD) and air    feed to chickens
                                                  sac infection caused     producing eggs for
                                                  by Mycoplasma            human consumption. Do
                                                  gallisepticum and        not use in feed
                                                  Escherichia coli         containing less than
                                                  susceptible to           0.55% dietary
                                                  oxytetracycline.         calcium. Use in such
                                                                           low calcium feeds may
                                                                           result in violative
                                                                           residues. Zero-day
                                                                           withdrawal period.
(iv) 400 g/ton.............  Robenidine, 30....  Broiler chickens: As an  Feed continuously for           066104
                                                  aid in the prevention    7 to 14 days. Do not
                                                  of coccidiosis caused    feed to chickens
                                                  by Eimeria necatrix,     producing eggs for
                                                  E. tenella, E.           human consumption. Do
                                                  acervulina, E.           not use in feed
                                                  brunetti, E. mivati,     containing less than
                                                  and E. maxima; and for   0.55% dietary
                                                  the control of chronic   calcium. Use in such
                                                  respiratory disease      low calcium feeds may
                                                  (CRD) and air sac        result in violative
                                                  infection caused by      residues. Withdraw 5
                                                  Mycoplasma               days before
                                                  gallisepticum and        slaughter.
                                                  Escherichia coli         Oxytetracycline as
                                                  susceptible to           provided by No.
                                                  oxytetracycline.         066104; robenidine as
                                                                           provided by No.
                                                                           054771 in Sec.
                                                                           510.600(c) of this
                                                                           chapter.
(v) 500 g/ton..............  ..................  Chickens: For reduction  Feed continuously for           066104
                                                  of mortality due to      5 days. Do not feed            069254
                                                  air sacculitis (air      to chickens producing
                                                  sac infection) caused    eggs for human
                                                  by E. coli susceptible   consumption. Do not
                                                  to oxytetracycline.      use in feed
                                                                           containing less than
                                                                           0.55% dietary
                                                                           calcium. Use in such
                                                                           low calcium feeds may
                                                                           result in violative
                                                                           residues. Withdraw 24
                                                                           hours before
                                                                           slaughter.
(vi) 500 g/ton.............  Monensin, 90 to     Broiler chickens: As an  Feed for 5 days as the          066104
                              100.                aid in the prevention    sole ration. Treat at
                                                  of coccidiosis caused    first clinical signs
                                                  by Eimeria necatrix,     of the disease. Do
                                                  E. tenella, E.           not feed to laying
                                                  acervulina, E.           chickens. Do not feed
                                                  brunetti, E. mivati,     to chickens over 16
                                                  and E. maxima; and as    weeks of age. Do not
                                                  an aid in the            use in feed
                                                  reduction of mortality   containing less than
                                                  due to air-sacculitis    0.55% dietary
                                                  (air sac infection)      calcium. Use in such
                                                  caused by Escherichia    low calcium feeds may
                                                  coli sensitive to        result in violative
                                                  oxytetracycline.         residues. Withdraw 72
                                                                           hours before
                                                                           slaughter. See Sec.
                                                                           558.355(d) of this
                                                                           chapter.
                                                                           Oxytetracycline as
                                                                           provided by No.
                                                                           066104; monensin as
                                                                           provided by No.
                                                                           058198 in Sec.
                                                                           510.600(c) of this
                                                                           chapter.

[[Page 95011]]

 
(vii) 500 g/ton............  Salinomycin, 40 to  Chickens: For the        Feed for 5 days as the          066104
                              60.                 prevention of            sole ration. Treat at          016592
                                                  coccidiosis caused by    first clinical signs
                                                  Eimeria necatrix, E.     of the disease. Do
                                                  tenella, E.              not feed to laying
                                                  acervulina, E.           chickens. Do not use
                                                  brunetti, E. mivati,     in feed containing
                                                  and E. maxima; and as    less than 0.55%
                                                  an aid in the            dietary calcium. Use
                                                  reduction of mortality   in such low calcium
                                                  due to air-sacculitis    feeds may result in
                                                  (air sac infection)      violative residues.
                                                  caused by E. coli        Withdraw 24 hours
                                                  sensitive to             before slaughter.
                                                  oxytetracycline.         Oxytetracycline as
                                                                           provided by No.
                                                                           066104; salinomycin
                                                                           as provided by No.
                                                                           016592 in Sec.
                                                                           510.600(c) of this
                                                                           chapter.
----------------------------------------------------------------------------------------------------------------

    (2) Turkeys--

----------------------------------------------------------------------------------------------------------------
      Oxytetracycline amount             Indications for use                Limitations               Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 100 g/ton.....................  Turkeys: For control of        Feed continuously for 7 to 14          066104
                                     hexamitiasis caused by         days. Do not feed to turkeys          069254
                                     Hexamita meleagridis           producing eggs for human
                                     susceptible to                 consumption. Zero-day
                                     oxytetracycline.               withdrawal period.
(ii) 200 g/ton....................  Turkeys: For control of        Feed continuously for 7 to 14          066104
                                     infectious synovitis caused    days. Do not feed to turkeys          069254
                                     by M. synoviae susceptible     producing eggs for human
                                     to oxytetracycline.            consumption. For No. 066104,
                                                                    withdraw 5 days before
                                                                    slaughter. For No. 069254,
                                                                    zero-day withdrawal period.
(iii) 25 mg/lb of body weight       Turkeys: For control of        Feed continuously for 7 to 14          066104
 daily.                              complicating bacterial         days. Do not feed to turkeys          069254
                                     organisms associated with      producing eggs for human
                                     bluecomb (transmissible        consumption. For No. 066104,
                                     enteritis; coronaviral         withdraw 5 days before
                                     enteritis) susceptible to      slaughter. For No. 069254,
                                     oxytetracycline.               zero-day withdrawal period.
----------------------------------------------------------------------------------------------------------------

    (3) Swine--

----------------------------------------------------------------------------------------------------------------
                               Combination in
   Oxytetracycline amount         grams/ton        Indications for use          Limitations           Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 10 mg/lb of body weight  ..................  1. Swine: For treatment  Feed continuously for           066104
 daily.                                           of bacterial enteritis   7 to 14 days.                  069254
                                                  caused by Escherichia
                                                  coli and Salmonella
                                                  choleraesuis
                                                  susceptible to
                                                  oxytetracycline and
                                                  treatment of bacterial
                                                  pneumonia caused by
                                                  Pasteurella multocida
                                                  susceptible to
                                                  oxytetracycline.
                                                 2. Breeding swine: For   Feed continuously for           066104
                                                  control and treatment    14 days.                       069254
                                                  of leptospirosis
                                                  (reducing the
                                                  incidence of abortion
                                                  and shedding of
                                                  leptospirae) caused by
                                                  Leptospira pomona
                                                  susceptible to
                                                  oxytetracycline.
(ii) 10 mg/lb of body        Carbadox, 10 to 25  Swine: For treatment of  Feed continuously as            066104
 weight daily.                                    bacterial enteritis      the sole ration for 7
                                                  caused by E. coli and    to 14 days. Not for
                                                  Salmonella               use in pregnant swine
                                                  choleraesuis             or swine intended for
                                                  susceptible to           breeding purposes. Do
                                                  oxytetracycline and      not mix in feeds
                                                  treatment of bacterial   containing bentonite.
                                                  pneumonia caused by      Do not feed to swine
                                                  Pasteurella multocida    within 42 days of
                                                  susceptible to           slaughter.
                                                  oxytetracycline; and     Oxytetracycline and
                                                  for increased rate of    carbadox as provided
                                                  weight gain and          by No. 066104 in Sec.
                                                  improved feed              510.600(c) of this
                                                  efficiency.              chapter.
----------------------------------------------------------------------------------------------------------------

    (4) Cattle--

[[Page 95012]]



----------------------------------------------------------------------------------------------------------------
                               Combination in
   Oxytetracycline amount         grams/ton        Indications for use          Limitations           Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 10 mg/lb of body weight  ..................  1. Calves and beef and   Feed continuously for           066104
 daily.                                           nonlactating dairy       7 to 14 days. For No.          069254
                                                  cattle: For treatment    069254, withdraw 5
                                                  of bacterial enteritis   days before
                                                  caused by Escherichia    slaughter. For No.
                                                  coli and bacterial       066104, zero-day
                                                  pneumonia (shipping      withdrawal period.
                                                  fever complex) caused
                                                  by Pasteurella
                                                  multocida susceptible
                                                  to oxytetracycline.
                                                 2. Calves: For           Feed continuously for           066104
                                                  treatment of bacterial   7 to 14 days in milk           069254
                                                  enteritis caused by E.   replacer or starter
                                                  coli susceptible to      feed. This product is
                                                  oxytetracycline.         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. For No.
                                                                           069254, withdraw 5
                                                                           days before
                                                                           slaughter. For No.
                                                                           066104, zero-day
                                                                           withdrawal period.
(ii) 75 mg/head/day........  ..................  Growing cattle (over     Feed continuously.....          066104
                                                  400 lb): For reduction                                  069254
                                                  of incidence of liver
                                                  abscesses.
(iii) 0.5 to 2.0 g/head/day  ..................  Cattle: For prevention   Feed 3 to 5 days                066104
                                                  and treatment of the     before and after               069254
                                                  early stages of          arrival in feedlots.
                                                  shipping fever complex.
----------------------------------------------------------------------------------------------------------------

    (5) Minor species--

----------------------------------------------------------------------------------------------------------------
       Oxytetracycline amount              Indications for use               Limitations              Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 10 mg/lb of body weight daily...  Sheep: For treatment of       Feed continuously for 7 to            066104
                                       bacterial enteritis caused    14 days; withdraw 5 days             069254
                                       by E. coli and bacterial      before slaughter.
                                       pneumonia caused by P.
                                       multocida susceptible to
                                       oxytetracycline.
(ii) 200 mg/colony..................  Honey bees: For control of    Remove at least 6 weeks               066104
                                       American foulbrood caused     prior to main honey flow.            069254
                                       by Paenibacillus larvae and
                                       European foulbrood caused
                                       by Streptococcus pluton
                                       susceptible to
                                       oxytetracycline.
(iii) 250 mg/kilogram of fish/day     Pacific salmon: For marking   For salmon not over 30 g              066104
 (11.35 g/100 lb of fish/day).         of skeletal tissue.           body weight; administer as
                                                                     sole ration for 4
                                                                     consecutive days; fish not
                                                                     to be liberated for at
                                                                     least 7 days following the
                                                                     last administration of
                                                                     medicated feed.
(iv) 2.5 to 3.75 g/100 lb of fish/    1. Salmonids: For control of  Administer in mixed ration            066104
 day.                                  ulcer disease caused by       for 10 days; do not
                                       Haemophilus piscium,          liberate fish or slaughter
                                       furunculosis caused by        fish for food for 21 days
                                       Aeromonas salmonicida,        following the last
                                       bacterial hemorrhagic         administration of medicated
                                       septicemia caused by A.       feed.
                                       liquefaciens, and
                                       pseudomonas disease.
                                      2. Catfish: For control of    Administer in mixed ration            066104
                                       bacterial hemorrhagic         for 10 days; do not
                                       septicemia caused by A.       liberate fish or slaughter
                                       liquefaciens and              fish for food for 21 days
                                       pseudomonas disease.          following the last
                                                                     administration of medicated
                                                                     feed; do not administer
                                                                     when water temperature is
                                                                     below 16.7 [deg]C (62
                                                                     [deg]F).
(v) 3.75 g/100 lb of fish/day.......  1. Freshwater-reared          Administer in mixed ration            066104
                                       salmonids: For control of     for 10 days; do not
                                       mortality due to coldwater    liberate fish or slaughter
                                       disease associated with       fish for food for 21 days
                                       Flavobacterium                following the last
                                       psychrophilum.                administration of medicated
                                                                     feed.
                                      2. Freshwater-reared          Administer in mixed ration            066104
                                       Oncorhynchus mykiss: For      for 10 days; do not
                                       control of mortality due to   liberate fish or slaughter
                                       columnaris disease            fish for food for 21 days
                                       associated with               following the last
                                       Flavobacterium columnare.     administration of medicated
                                                                     feed.
(vi) 1 g/lb of medicated feed.......  Lobsters: For control of      Administer as sole ration             066104
                                       gaffkemia caused by           for 5 consecutive days;
                                       Aerococcus viridans.          withdraw medicated feed 30
                                                                     days before harvesting
                                                                     lobsters.
----------------------------------------------------------------------------------------------------------------


0
28. In Sec.  558.455, revise paragraph (d); remove and reserve 
paragraphs (e)(1)(i), (e)(2)(i), (e)(3)(i), (e)(4)(i), (e)(4)(ii), and 
(e)(4)(iv); and in paragraph (e)(4)(v), remove ``increased rate of 
weight gain; improved feed efficiency, and'' to read as follows:


Sec.  558.455  Oxytetracycline and neomycin.

* * * * *
    (d) Special considerations--(1) Federal law restricts medicated 
feed containing this veterinary feed directive (VFD) drug to use by or 
on the order of a licensed veterinarian. See Sec.  558.6 for additional 
requirements.
    (2) The expiration date of VFDs for oxytetracycline and neomycin

[[Page 95013]]

medicated feeds must not exceed 6 months from the date of issuance. 
VFDs for oxytetracycline and neomycin shall not be refilled.
    (3) Cattle feeds shall bear the following warning statement: ``Use 
of more than one product containing neomycin or failure to follow 
withdrawal times may result in illegal drug residues.''
* * * * *


Sec.  558.460  [Removed]

0
29. Remove Sec.  558.460.

0
30. In Sec.  558.485, remove paragraphs (e)(1)(v) through (xii); and 
add paragraph (e)(3) to read as follows:


Sec.  558.485   Pyrantel.

* * * * *
    (e) * * *
    (3) Pyrantel may also be used in combination with:
    (i) Lincomycin as in Sec.  558.325.
    (ii) Tylosin as in Sec.  558.325.

0
31. In Sec.  558.500, remove and reserve paragraphs (e)(1)(ii), (iii), 
and (iv), (e)(2)(iv), (e)(2)(ix) and (x); remove paragraph 
(e)(2)(xiii); and add paragraph (e)(4) to read as follows:


Sec.  558.500  Ractopamine.

* * * * *
    (e) * * *
    (4) Ractopamine may also be used in combination with tylosin in as 
in Sec.  558.625.

0
32. In Sec.  558.515, in the table in paragraph (d), remove the row 
entries for ``Chlortetracycline 100 to 200'', ``Chlortetracycline 200 
to 400'', ``Chlortetracycline 500'', ``Lincomycin 2'', and 
``Oxytetracycline 400'' in the ``Combination in grams/ton'' column; and 
add paragraph (e) to read as follows:


Sec.  558.515  Robenidine.

* * * * *
    (e) Robenidine may also be used in combination with:
    (1) Chlortetracycline as in Sec.  558.128.
    (2) Lincomycin as in Sec.  558.325.
    (3) Oxytetracycline as in Sec.  558.450.

0
33. In Sec.  558.550, remove and reserve paragraphs (d)(1)(x), 
(d)(1)(xi), (d)(1)(xiii), and (d)(1)(xvi); and revise paragraph (d)(4) 
to read as follows:


Sec.  558.550  Salinomycin.

* * * * *
    (d) * * *
    (5) Salinomycin may also be used in combination with:
    (i) [Reserved]
    (ii) [Reserved]
    (iii) Chlortetracycline as in Sec.  558.128.
    (iv) Lincomycin as in Sec.  558.325.
    (v) Oxytetracycline as in Sec.  558.450.
    (vi) Virginiamycin as in Sec.  558.635.

0
34. In Sec.  558.555, remove paragraphs (d)(3) through (5); (e)(3) and 
(e)(4); remove and reserve paragraph (e)(2); and add paragraph (f) to 
read as follows:


Sec.  558.555  Semduramycin.

* * * * *
    (f) Semduramycin may also be used in combination with virginiamycin 
as in Sec.  558.635.

0
35. In Sec.  558.575, revise the section heading; redesignate 
paragraphs (b), (c), and (d) as paragraphs (c), (d), and (e); revise 
paragraph (a); and add new paragraphs (b) and (d) to read as follows:


Sec.  558.575  Sulfadimethoxine and ormetoprim.

    (a) Specifications. Type A medicated articles containing either:
    (1) 25 percent sulfadimethoxine and 15 percent ormetoprim; or
    (2) 25 percent sulfadimethoxine and 5 percent ormetoprim.
    (b) Sponsors. See sponsors in Sec.  510.600(c) of this chapter for 
use as in paragraph (d) of this section:
    (1) No. 054771 for use of the product described in paragraph (a)(1) 
as in paragraphs (e)(1), (e)(2), (e)(3), (e)(4), and (e)(7) of this 
section.
    (2) No. 015331 for use of the product described in paragraph (a)(2) 
as in paragraphs (e)(5) and (e)(6) of this section.
* * * * *
    (d) Special considerations.--(1) Federal law restricts medicated 
feed containing this veterinary feed directive (VFD) drug to use by or 
on the order of a licensed veterinarian. See Sec.  558.6 for additional 
requirements.
    (2) The expiration date of VFDs for sulfadimethoxine and ormetoprim 
medicated feeds must not exceed 6 months from the date of issuance. 
VFDs for sulfadimethoxine and ormetoprim shall not be refilled.
* * * * *

0
36. Revise Sec.  558.582 to read as follows:


Sec.  558.582  Sulfamerazine.

    (a) Specifications. Type A medicated articles containing 99 percent 
sulfamerazine.
    (b) Sponsor. See No. 054771 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec.  556.660 of this chapter.
    (d) Special considerations--(1) Federal law restricts medicated 
feed containing this veterinary feed directive (VFD) drug to use by or 
on the order of a licensed veterinarian. See Sec.  558.6 for additional 
requirements.
    (2) The expiration date of VFDs for sulfamerazine medicated feeds 
must not exceed 6 months from the date of issuance. VFDs for 
sulfamerazine shall not be refilled.
    (e) Conditions of use. It is used in fish feed for as follows:

----------------------------------------------------------------------------------------------------------------
                                Combination in
   Sulfamerazine grams/ton         grams/ton        Indications for use         Limitations           Sponsor
----------------------------------------------------------------------------------------------------------------
(1) To deliver 10 grams of    ..................  Rainbow trout, brook    Formulate to deliver            054771
 sulfamerazine per 100                             trout, and brown        10 grams of
 pounds of fish per day.                           trout: For control of   sulfamerazine per 100
                                                   furunculosis.           pounds of fish per
                                                                           day. Treat for not
                                                                           more than 14 days. Do
                                                                           not treat within 3
                                                                           weeks of marketing or
                                                                           stocking in stream
                                                                           open to fishing.
(2) [Reserved]..............
----------------------------------------------------------------------------------------------------------------


0
37. Revise Sec.  558.586 to read as follows:


Sec.  558.586  Sulfaquinoxaline.

    (a) Specifications. Type A medicated articles containing 40 percent 
sulfaquinoxaline.
    (b) Sponsor. See No. 016592 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec.  556.685 of this chapter.
    (d) Special considerations--(1) Federal law restricts medicated 
feed containing this veterinary feed directive (VFD) drug to use by or 
on the order of a licensed veterinarian. See Sec.  558.6 for additional 
requirements.
    (2) The expiration date of VFDs for sulfaquinoxaline medicated 
feeds must not exceed 6 months from the date of issuance. VFDs for 
sulfaquinoxaline shall not be refilled.
    (e) Conditions of use--(1) Chickens--

[[Page 95014]]



----------------------------------------------------------------------------------------------------------------
 Sulfaquinoxaline in grams/    Combination in
            ton                   grams/ton        Indications for use          Limitations           Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 0.015 percent..........  ..................  As an aid in preventing  Feed continuously from          016592
                                                  outbreaks of             the time birds are
                                                  coccidiosis caused by    placed on litter and
                                                  Eimeria tenella, E.      continue past the age
                                                  necatrix, E.             when coccidiosis is
                                                  acervulina, E. maxima,   ordinarily a hazard.
                                                  and E. brunetti under    If death losses
                                                  average conditions of    exceed 0.5 percent in
                                                  exposure.                a 2-day period,
                                                                           obtain a laboratory
                                                                           diagnosis. If
                                                                           coccidiosis is the
                                                                           cause, use the
                                                                           sulfaquinoxaline
                                                                           levels recommended
                                                                           for control of
                                                                           outbreaks, returning
                                                                           to the original
                                                                           dosage schedule after
                                                                           the outbreak has
                                                                           subsided. Losses may
                                                                           result from
                                                                           intercurrent disease,
                                                                           other conditions
                                                                           affecting drug
                                                                           intake, or variant
                                                                           strains of coccidia
                                                                           species which can
                                                                           contribute to the
                                                                           virulence of
                                                                           coccidiosis under
                                                                           field conditions. Do
                                                                           not treat chickens
                                                                           within 10 days of
                                                                           slaughter. Do not
                                                                           medicate chickens
                                                                           producing eggs for
                                                                           human consumption.
(ii) 0.0175 percent........  ..................  As an aid in preventing  Feed continuously from          016592
                                                  outbreaks of             the time birds are
                                                  coccidiosis caused by    placed on litter and
                                                  Eimeria tenella, E.      continue past the age
                                                  necatrix, E.             when coccidiosis is
                                                  acervulina, E. maxima,   ordinarily a hazard.
                                                  and E. brunetti where    If death losses
                                                  excessive exposure to    exceed 0.5 percent in
                                                  coccidia is increased    a 2-day period,
                                                  due to overcrowding or   obtain a laboratory
                                                  other management         diagnosis. If
                                                  factors.                 coccidiosis is the
                                                                           cause, use the
                                                                           sulfaquinoxaline
                                                                           levels recommended
                                                                           for control of
                                                                           outbreaks, returning
                                                                           to the original
                                                                           dosage schedule after
                                                                           the outbreak has
                                                                           subsided. Losses may
                                                                           result from
                                                                           intercurrent disease,
                                                                           other conditions
                                                                           affecting drug
                                                                           intake, or variant
                                                                           strains of coccidia
                                                                           species which can
                                                                           contribute to the
                                                                           virulence of
                                                                           coccidiosis under
                                                                           field conditions. Do
                                                                           not treat chickens
                                                                           within 10 days of
                                                                           slaughter. Do not
                                                                           medicate chickens
                                                                           producing eggs for
                                                                           human consumption.
(iii) 0.1 to 0.05 percent..  ..................  As an aid in             Feed at 0.1 percent             016592
                                                  controlling outbreaks    level for first 48 to
                                                  of coccidiosis caused    72 hours. Skip 3
                                                  by Eimeria tenella, E.   days; 0.05 percent
                                                  necatrix, E.             for 2 days, skip 3
                                                  acervulina, E. maxima,   days; 0.05 percent
                                                  and E. brunetti.         for 2 days. If bloody
                                                                           droppings recur, give
                                                                           0.05 percent for
                                                                           another 2 days. Do
                                                                           not treat chickens
                                                                           within 10 days of
                                                                           slaughter. Do not
                                                                           medicate chickens
                                                                           producing eggs for
                                                                           human consumption.
(iv) 0.05 or 0.1 percent...  ..................  As an aid in the         Feed 0.1 percent for            016592
                                                  control of acute fowl    48 to 72 hours.
                                                  cholera caused by        Mortality should be
                                                  Pasteurella multocida    brought under
                                                  susceptible to           control. After
                                                  sulfaquinoxaline and     medication, move
                                                  fowl typhoid caused by   birds to clean ground
                                                  Salmonella gallinarum    or to a clean house.
                                                  susceptible to           If disease recurs,
                                                  sulfaquinoxaline.        use 0.05 percent in
                                                                           feed again for 2
                                                                           days. Do not treat
                                                                           chickens or turkeys
                                                                           within 10 days of
                                                                           slaughter for food.
                                                                           Do not medicate
                                                                           chickens or turkeys
                                                                           producing eggs for
                                                                           human consumption.
----------------------------------------------------------------------------------------------------------------

    (2) Turkeys--

[[Page 95015]]



----------------------------------------------------------------------------------------------------------------
 Sulfaquinoxaline in grams/    Combination in
            ton                   grams/ton        Indications for use          Limitations           Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 0.0175 percent.........  ..................  As an aid in preventing  Feed continuously               016592
                                                  outbreaks of             during time birds are
                                                  coccidiosis caused by    closely confined. May
                                                  Eimeria meleagrimitis    be continued for a
                                                  and E. adenoeides.       week to 10 days after
                                                                           flock is transferred
                                                                           to range to reduce
                                                                           danger of an outbreak
                                                                           following moving of
                                                                           the flock. Do not
                                                                           treat turkeys within
                                                                           10 days of slaughter.
                                                                           Do not medicate
                                                                           turkeys producing
                                                                           eggs for human
                                                                           consumption.
(ii) 0.05 percent..........  ..................  As an aid in             Feed for 2 days.                016592
                                                  controlling outbreaks    Follow with 3 days on
                                                  of coccidiosis caused    regular feed and 2
                                                  by Eimeria               more days on 0.05
                                                  meleagrimitis and E.     percent
                                                  adenoeides.              sulfaquinoxaline
                                                                           feed. Again follow
                                                                           with 3 days on
                                                                           regular feed and 2
                                                                           more days on 0.05
                                                                           percent
                                                                           sulfaquinoxaline
                                                                           feed. Continue this
                                                                           schedule if necessary
                                                                           until all signs of
                                                                           the outbreaks have
                                                                           subsided. Do not
                                                                           treat turkeys within
                                                                           10 days of slaughter.
                                                                           Do not medicate
                                                                           turkeys producing
                                                                           eggs for human
                                                                           consumption.
(iii) 0.05 or 0.1 percent..  ..................  As an aid in the         Feed 0.1 percent for            016592
                                                  control of acute fowl    48 to 72 hours.
                                                  cholera caused by        Mortality should be
                                                  Pasteurella multocida    brought under
                                                  susceptible to           control. After
                                                  sulfaquinoxaline and     medication, move
                                                  fowl typhoid caused by   birds to clean ground
                                                  Salmonella gallinarum    or to a clean house.
                                                  susceptible to           If disease recurs,
                                                  sulfaquinoxaline.        use 0.05 percent in
                                                                           feed again for 2
                                                                           days. Do not treat
                                                                           chickens or turkeys
                                                                           within 10 days of
                                                                           slaughter for food.
                                                                           Do not medicate
                                                                           chickens or turkeys
                                                                           producing eggs for
                                                                           human consumption.
----------------------------------------------------------------------------------------------------------------

    (3) Rabbits--

----------------------------------------------------------------------------------------------------------------
 Sulfaquinoxaline in grams/    Combination in
            ton                   grams/ton        Indications for use          Limitations           Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 0.025 percent..........  ..................  As an aid in preventing  Treatment to be                 016592
                                                  coccidiosis caused by    started after
                                                  Eimeria stiedae.         weaning. Feed
                                                                           continuously for 30
                                                                           days or feed
                                                                           medicated feed for 2
                                                                           days out of every
                                                                           week until marketing.
                                                                           Do not treat within
                                                                           10 days of slaughter.
(ii) 0.1 percent...........  ..................  As an aid in             Feed for 2 weeks. Do            016592
                                                  controlling outbreaks    not treat within 10
                                                  of coccidiosis caused    days of slaughter.
                                                  by Eimeria stiedae.
----------------------------------------------------------------------------------------------------------------


0
38. In Sec.  558.612, remove paragraphs (e)(1)(i) and (e)(1)(iii); 
redesignate paragraphs (e)(1)(ii) and (e)(1)(iv) as new paragraphs 
(e)(1)(i) and (ii); and add paragraph (e)(2) to read as follows:


Sec.  558.612  Tiamulin.

* * * * *
    (e) * * *
    (2) Tiamulin may also be used in combination with chlortetracycline 
as in Sec.  558.128.

0
39. Amend Sec.  558.625 as follows:
0
a. Remove paragraph (d);
0
b. Redesignate paragraphs (c), (e), and (f) as paragraphs (d), (c) and 
(e); and
0
c. Revise paragraph (b) and redesignated paragraphs (d) and (e).
    The revisions read as follows:


Sec.  558.625   Tylosin.

* * * * *
    (b) Sponsors. See sponsor numbers in Sec.  510.600(c) of this 
chapter.
    (1) No. 016592: Type medicated article containing 100 grams per 
pound.
    (2) No. 054771: Type medicated article containing 40 grams per 
pound.
    (3) No. 058198: Type medicated article containing 10, 40, or 100 
grams per pound.
    (4) No. 066104: Type medicated article containing 20 or 40 grams 
per pound.
    (c) Related tolerances. See Sec.  556.360 of this chapter.
    (d) Special considerations--(1) Federal law restricts medicated 
feed containing this veterinary feed directive (VFD) drug to use by or 
on the order of a licensed veterinarian. See Sec.  558.6 for additional 
requirements.
    (2) The expiration date of VFDs for oxytetracycline medicated feeds 
must not exceed 6 months from the date of issuance. VFDs for 
oxytetracycline shall not be refilled.
    (3) Type C medicated feeds for cattle may be manufactured from 
tylosin liquid Type B medicated feeds which have a pH between 4.5 and 
6.0 and which bear appropriate mixing directions as follows:
    (i) For liquid feeds stored in recirculating tank systems: 
Recirculate immediately prior to use for not less than 10 minutes, 
moving not less than 1 percent of the tank contents per minute from the 
bottom of the tank to the top. Recirculate daily as described even when 
not used.
    (ii) For liquid feeds stored in mechanical, air, or other 
agitation-type tank systems: Agitate immediately prior to use for not 
less than 10 minutes, creating a turbulence at the bottom of

[[Page 95016]]

the tank that is visible at the top. Agitate daily as described even 
when not used.
    (e) Conditions of use--(1) Swine--

----------------------------------------------------------------------------------------------------------------
                               Combination in
     Tylosin  grams/ton           grams/ton        Indications for use          Limitations          Sponsors
----------------------------------------------------------------------------------------------------------------
(i) 40 or 100..............  ..................  For control of swine     Feed as the sole                016592
                                                  dysentery associated     ration 100 g of                054771
                                                  with Brachyspira         tylosin per ton of             058198
                                                  hyodysenteriae.          complete feed for at           066104
                                                                           least 3 weeks. Follow
                                                                           with 40 grams per ton
                                                                           of complete feed
                                                                           until market weight.
(ii) 40 or 100.............  Pyrantel, 96......  For control of swine     Feed as the sole                066104
                                                  dysentery associated     ration 100 g of
                                                  with Brachyspira         tylosin per ton of
                                                  hyodysenteriae; and as   complete feed for at
                                                  an aid in the            least 3 weeks. Follow
                                                  prevention of            with 40 grams per ton
                                                  migration and            of complete feed
                                                  establishment of large   until market weight.
                                                  roundworm (Ascaris       Tylosin phosphate and
                                                  suum) infections; aid    pyrantel as provided
                                                  in the prevention of     by No. 066104 in Sec.
                                                  establishment of           510.600(c) of this
                                                  nodular worm             chapter.
                                                  (Oesophagostomum spp.)
                                                  infections.
(iii) 40 or 100............  ..................  For control of porcine   Feed as the sole                016592
                                                  proliferative            ration 100 g of                054771
                                                  enteropathies            tylosin per ton of             058198
                                                  (ileitis) associated     complete feed for at           066104
                                                  with Lawsonia            least 3 weeks. Follow
                                                  intracellularis.         with 40 grams per ton
                                                                           of complete feed
                                                                           until market weight.
(iv) 40 or 100.............  Pyrantel, 96......  For control of porcine   Feed as the sole                066104
                                                  proliferative            ration 100 g of
                                                  enteropathies            tylosin per ton of
                                                  (ileitis) associated     complete feed for at
                                                  with Lawsonia            least 3 weeks. Follow
                                                  intracellularis; and     with 40 grams per ton
                                                  as an aid in the         of complete feed
                                                  prevention of            until market weight.
                                                  migration and            Tylosin phosphate and
                                                  establishment of large   pyrantel as provided
                                                  roundworm (Ascaris       by No. 066104 in Sec.
                                                  suum) infections; aid      510.600(c) of this
                                                  in the prevention of     chapter.
                                                  establishment of
                                                  nodular worm
                                                  (Oesophagostomum spp.)
                                                  infections.
(v) 40 or 100..............  Ractopamine, 4.5    Finishing swine: For     Feed continuously as            016592
                              to 9.0.             the control of swine     the sole ration to             054771
                                                  dysentery associated     finishing swine                058198
                                                  with Brachyspira         weighing not less
                                                  hyodysenteriae; for      than 150 lbs for the
                                                  control of porcine       last 45 to 90 lbs
                                                  proliferative            (group average) of
                                                  enteropathies            weight gain prior to
                                                  (ileitis) associated     slaughter. Include
                                                  with Lawsonia            100 g/ton of tylosin
                                                  intracellularis; and     for at least 3 weeks,
                                                  for increased rate of    followed by 40 g/ton
                                                  weight gain, improved    until market weight.
                                                  feed efficiency, and     Tylosin phosphate as
                                                  increased carcass        provided by Nos.
                                                  leanness in finishing    058198 and 016592;
                                                  swine weighing not       ractopamine as
                                                  less than 150 lbs, fed   provided by Nos.
                                                  a complete ration        058198 and 054771 in
                                                  containing at least      Sec.   510.600(c) of
                                                  16% crude protein for    this chapter.
                                                  the last 45 to 90 lbs
                                                  of gain prior to
                                                  slaughter.
(vi) 40 to 100.............  ..................  For the treatment and    Administer as tylosin           016592
                                                  control of swine         phosphate in feed              054771
                                                  dysentery associated     continuously as the            058198
                                                  with Brachyspira         sole ration for 2 to           066104
                                                  hyodysenteriae           6 weeks, immediately
                                                  immediately after        after treatment with
                                                  medicating with          tylosin tartrate in
                                                  tylosin in drinking      drinking water for 3
                                                  water.                   to 10 days as in Sec.
                                                                             520.2640(d)(3) of
                                                                           this chapter.
(vii) 40 to 100............  Pyrantel, 96......  For the treatment and    Administer as tylosin           066104
                                                  control of swine         phosphate in feed
                                                  dysentery associated     continuously as the
                                                  with Brachyspira         sole ration for 2 to
                                                  hyodysenteriae           6 weeks, immediately
                                                  immediately after        after treatment with
                                                  medicating with          tylosin tartrate in
                                                  tylosin in drinking      drinking water for 3
                                                  water; and as an aid     to 10 days as in Sec.
                                                  in the prevention of       520.2640(d)(3) of
                                                  migration and            this chapter. Tylosin
                                                  establishment of large   phosphate and
                                                  roundworm (Ascaris       pyrantel as provided
                                                  suum) infections; aid    by No. 066104 in Sec.
                                                  in the prevention of       510.600(c) of this
                                                  establishment of         chapter.
                                                  nodular worm
                                                  (Oesophagostomum spp.)
                                                  infections.
(viii) 40 to 100...........  ..................  For the control of       Administer as tylosin           016592
                                                  porcine proliferative    phosphate in feed              054771
                                                  enteropathies (PPE,      continuously as the            058198
                                                  ileitis) associated      sole ration for 2 to           066104
                                                  with Lawsonia            6 weeks, immediately
                                                  intracellularis          after treatment with
                                                  immediately after        tylosin tartrate in
                                                  medicating with          drinking water for 3
                                                  tylosin in drinking      to 10 days as in Sec.
                                                  water.                     520.2640(d)(3) of
                                                                           this chapter.

[[Page 95017]]

 
(ix) 40 to 100.............  Pyrantel, 96......  For the control of       Administer as tylosin           066104
                                                  porcine proliferative    phosphate in feed
                                                  enteropathies (PPE,      continuously as the
                                                  ileitis) associated      sole ration for 2 to
                                                  with Lawsonia            6 weeks, immediately
                                                  intracellularis          after treatment with
                                                  immediately after        tylosin tartrate in
                                                  medicating with          drinking water for 3
                                                  tylosin in drinking      to 10 days as in Sec.
                                                  water; and as an aid       520.2640(d)(3) of
                                                  in the prevention of     this chapter. Tylosin
                                                  migration and            phosphate and
                                                  establishment of large   pyrantel as provided
                                                  roundworm (Ascaris       by No. 066104 in Sec.
                                                  suum) infections; aid      510.600(c) of this
                                                  in the prevention of     chapter.
                                                  establishment of
                                                  nodular worm
                                                  (Oesophagostomum spp.)
                                                  infections.
(x) 40 to 100..............  Ractopamine, 4.5    Finishing swine: For     Feed continuously as            016592
                              to 9.0.             the treatment and        the sole ration to             054771
                                                  control of swine         finishing swine                058198
                                                  dysentery associated     weighing not less
                                                  with Brachyspira         than 150 lbs for the
                                                  hyodysenteriae, for      last 45 to 90 lbs
                                                  control of porcine       (group average) of
                                                  proliferative            weight gain prior to
                                                  enteropathies (PPE,      slaughter. Include 40
                                                  ileitis) associated      to 100 grams of
                                                  with Lawsonia            tylosin phosphate per
                                                  intracellularis; and     ton of complete feed
                                                  for increased rate of    for 2 to 6 weeks,
                                                  weight gain, improved    immediately after
                                                  feed efficiency, and     treatment with
                                                  increased carcass        tylosin tartrate in
                                                  leanness in finishing    drinking water for 3
                                                  swine weighing not       to 10 days as in Sec.
                                                  less than 150 lbs, fed     520.2640(d)(3) of
                                                  a complete ration        this chapter. Tylosin
                                                  containing at least      phosphate as provided
                                                  16% crude protein for    by Nos. 058198 and
                                                  the last 45 to 90 lbs    016592; ractopamine
                                                  of gain prior to         as provided by Nos.
                                                  slaughter.               058198 and 054771 in
                                                                           Sec.   510.600(c) of
                                                                           this chapter.
(xi) 100...................  ..................  For reduction in         Feed continuously as            016592
                                                  severity of effects of   the sole ration.               054771
                                                  atrophic rhinitis.                                      058198
                                                                                                          066104
(xii) 100..................  Pyrantel, 96......  For reduction in         Feed continuously as            066104
                                                  severity of effects of   the sole ration.
                                                  atrophic rhinitis; aid   Tylosin phosphate and
                                                  as an aid in the         pyrantel as provided
                                                  prevention of            by No. 066104 in Sec.
                                                  migration and              510.600(c) of this
                                                  establishment of large   chapter. Tylosin
                                                  roundworm (Ascaris       phosphate and
                                                  suum) infections; aid    pyrantel as provided
                                                  in the prevention of     by No. 066104 in Sec.
                                                  establishment of           510.600(c) of this
                                                  nodular worm             chapter.
                                                  (Oesophagostomum spp.)
                                                  infections.
(xiii) 100.................  Ractopamine, 4.5    For the control of       Feed continuously as            016592
                              to 9.0.             porcine proliferative    the sole ration to             054771
                                                  enteropathies (PPE,      finishing swine                058198
                                                  ileitis) associated      weighing not less
                                                  with Lawsonia            than 150 lbs for the
                                                  intracellularis; and     last 45 to 90 lbs
                                                  for increased rate of    (group average) of
                                                  weight gain, improved    weight gain prior to
                                                  feed efficiency, and     slaughter. Include
                                                  increased carcass        100 g/ton of tylosin
                                                  leanness in finishing    for 3 weeks. Tylosin
                                                  swine weighing not       phosphate as provided
                                                  less than 150 lbs, fed   by Nos. 058198 and
                                                  a complete ration        016592; ractopamine
                                                  containing at least      as provided by Nos.
                                                  16% crude protein for    058198 and 054771 in
                                                  the last 45 to 90 lbs    Sec.   510.600(c) of
                                                  of gain prior to         this chapter.
                                                  slaughter.
----------------------------------------------------------------------------------------------------------------

    (2) Cattle--

----------------------------------------------------------------------------------------------------------------
                               Combination in
     Tylosin  grams/ton           grams/ton        Indications for use          Limitations          Sponsors
----------------------------------------------------------------------------------------------------------------
(i) 8 to 10................  ..................  Beef cattle: For         Feed continuously as           016592,
                                                  reduction of incidence   the sole ration to            054771,
                                                  of liver abscesses       provide 60 to 90 mg/   058198, 066104
                                                  caused by                head/day tylosin.
                                                  Fusobacterium
                                                  necrophorum and
                                                  Arcanobacterium
                                                  (Actinomyces) pyogenes.

[[Page 95018]]

 
(ii) 90 to 360.............  Lasalocid, 100 to   Heifers fed in           Feed continuously as            054771
                              1440 plus           confinement for          sole ration. Feed to           016592
                              melengestrol,       slaughter: For           heifers at the rate
                              0.25 to 2.0.        reduction of incidence   of 0.5 to 2.0
                                                  of liver abscesses       pound(s) per head per
                                                  caused by                day (specify one
                                                  Fusobacterium            level) to provide
                                                  necrophorum and          0.25 to 0.5 mg
                                                  Arcanobacterium          melengestrol acetate
                                                  pyogenes; and for        per head per day
                                                  increased rate of        (specify one level),
                                                  weight gain, improved    100 to 360 mg
                                                  feed efficiency, and     lasalocid per head
                                                  suppression of estrus    per day (specify one
                                                  (heat).                  level), and 90 mg
                                                                           tylosin per head per
                                                                           day. This Type C
                                                                           product may be top
                                                                           dressed onto or mixed
                                                                           into a complete feed
                                                                           prior to feeding.
                                                                           Tylosin as provided
                                                                           by Nos. 058198 and
                                                                           016592; lasalocid as
                                                                           provided by No.
                                                                           054771; melengestrol
                                                                           as provided by Nos.
                                                                           054771 and 058198 in
                                                                           Sec.   510.600(c) of
                                                                           this chapter.
(iii) 90 to 360............  Melengestrol, 0.25  Heifers fed in           Feed continuously as            054771
                              to 2.0.             confinement for          sole ration. Each
                                                  slaughter: For           pound contains 0.125
                                                  reduction of incidence   to 1.0 mg
                                                  of liver abscesses       melengestrol acetate
                                                  caused by                and 45 to 180 mg of
                                                  Fusobacterium            tylosin. Feed to
                                                  necrophorum and          heifers at a rate of
                                                  Arcanobacterium          0.5 to 2.0 pounds per
                                                  pyogenes; and for        head per day to
                                                  increased rate of        provide 0.25 to 0.5
                                                  weight gain, improved    mg melengestrol
                                                  feed efficiency, and     acetate and 60 to 90
                                                  suppression of estrus    mg tylosin per head
                                                  (heat).                  per day. Prior to
                                                                           feeding, this Type C
                                                                           product must be top-
                                                                           dressed onto a
                                                                           complete feed or
                                                                           mixed into the amount
                                                                           of complete feed
                                                                           consumed by an animal
                                                                           per day. Tylosin
                                                                           provided by No.
                                                                           058198; melengestrol
                                                                           provided by No.
                                                                           054771 in Sec.
                                                                           510.600(c) of this
                                                                           chapter.
(iv) 8 to 10...............  Monensin, 5 to 40.  Cattle fed in            Feed continuously as            016592
                                                  confinement for          sole ration to                 058198
                                                  slaughter: For           provide 50 to 480
                                                  reduction of incidence   monensin mg/head/day
                                                  of liver abscesses       and 60 to 90 mg/head/
                                                  caused by                day tylosin. A
                                                  Fusobacterium            withdrawal time has
                                                  necrophorum and          not been established
                                                  Arcanobacterium          for pre-ruminating
                                                  (Actinomyces)            calves. Do not use in
                                                  pyogenes; and for        calves to be
                                                  improved feed            processed for veal.
                                                  efficiency.              Tylosin provided by
                                                                           Nos. 016592 or
                                                                           058198; monensin as
                                                                           provided by No.
                                                                           058198 in Sec.
                                                                           510.600(c) of this
                                                                           chapter.
(v) 8 to 10................  Monensin, 10 to 40  Cattle fed in            Feed continuously as            016592
                                                  confinement for          sole ration to                 058198
                                                  slaughter: For           provide 0.14 to 0.42
                                                  reduction of incidence   mg monensin/lb body
                                                  of liver abscesses       weight per day,
                                                  caused by                depending on the
                                                  Fusobacterium            severity of the
                                                  necrophorum and          coccidiosis
                                                  Arcanobacterium          challenge, up to 480
                                                  (Actinomyces)            mg/head/day and 60 to
                                                  pyogenes; and for        90 mg/head/day
                                                  prevention of            tylosin. A withdrawal
                                                  coccidiosis caused by    time has not been
                                                  Eimeria bovis and E      established for pre-
                                                  zuernii.                 ruminating calves. Do
                                                                           not use in calves to
                                                                           be processed for
                                                                           veal. Tylosin
                                                                           provided by Nos.
                                                                           016592 or 058198;
                                                                           monensin as provided
                                                                           by No. 058198 in Sec.
                                                                             510.600(c) of this
                                                                           chapter.
(vi) 8 to 10...............  Monensin, 5 to 30   Cattle fed in            Feed continuously as            016592
                              plus decoquinate,   confinement for          the sole ration to             054771
                              13.6 to 22.7.       slaughter: For           provide 22.7 mg of
                                                  reduction of incidence   decoquinate per 100
                                                  of liver abscesses       lb body weight per
                                                  caused by                day, 50 to 360 mg of
                                                  Fusobacterium            monensin/head/day,
                                                  necrophorum and          and 60 to 90 mg of
                                                  Arcanobacterium          tylosin/head/day.
                                                  pyogenes; for the        Feed at least 28 days
                                                  prevention of            during period of
                                                  coccidiosis caused by    exposure to
                                                  Eimeria bovis and E.     coccidiosis or when
                                                  zuernii; and for         it is likely to be a
                                                  improved feed            hazard. Do not feed
                                                  efficiency.              to animals producing
                                                                           milk for food. Do not
                                                                           feed to lactating
                                                                           dairy cattle. A
                                                                           withdrawal time has
                                                                           not been established
                                                                           for pre-ruminating
                                                                           calves. Do not use in
                                                                           calves to be
                                                                           processed for veal.
                                                                           Tylosin as provided
                                                                           by Nos. 016592 and
                                                                           058198; monensin as
                                                                           provided by No.
                                                                           058198; decoquinate
                                                                           as provided by No.
                                                                           058198 in Sec.
                                                                           510.600(c) of this
                                                                           chapter.

[[Page 95019]]

 
(vii) 8 to 10..............  Monensin, 10 to 40  Heifers fed in           Feed continuously as            016592
                              plus                confinement for          sole ration to                 054771
                              melengestrol,       slaughter: For           heifers at a rate of           058198
                              0.25 to 2.0.        reduction of incidence   0.5 to 2.0 pounds per
                                                  of liver abscesses       head per day to
                                                  caused by                provide 0.25 to 0.5
                                                  Fusobacterium            mg/head/day
                                                  necrophorum and          melengestrol acetate
                                                  Arcanobacterium          and 0.14 to 0.42 mg
                                                  (Actinomyces)            monensin/lb body
                                                  pyogenes; for            weight per day,
                                                  prevention and control   depending on the
                                                  of coccidiosis caused    severity of the
                                                  by Eimeria bovis and E   coccidiosis
                                                  zuernii; and for         challenge, up to 480
                                                  increased rate of        mg/head/day and 60 to
                                                  weight gain, improved    90 mg/head/day
                                                  feed efficiency, and     tylosin. The
                                                  suppression of estrus    melengestrol acetate
                                                  (heat).                  portion of this Type
                                                                           C medicated feed must
                                                                           be mixed into the
                                                                           complete feed
                                                                           containing 10 to 40 g/
                                                                           ton monensin and 8 to
                                                                           10 g/ton tylosin at
                                                                           feeding into the
                                                                           amount of complete
                                                                           feed consumed by an
                                                                           animal per day. A
                                                                           withdrawal time has
                                                                           not been established
                                                                           for pre-ruminating
                                                                           calves. Do not use in
                                                                           calves to be
                                                                           processed for veal.
                                                                           Tylosin provided by
                                                                           Nos. 016592 or
                                                                           058198; monensin as
                                                                           provided by No.
                                                                           058198; melengestrol
                                                                           provided by Nos.
                                                                           054771 or 058198 in
                                                                           Sec.   510.600(c) of
                                                                           this chapter.
(viii) 8 to 10.............  Monensin, 10 to 40  Cattle fed in            Feed continuously as            054771
                              plus ractopamine,   confinement for          sole ration to                 058198
                              8.2 to 24.6.        slaughter: For           provide 70 to 430 mg/
                                                  reduction of incidence   head/day ractopamine
                                                  of liver abscesses       and 0.14 to 0.42 mg
                                                  caused by                monensin/lb body
                                                  Fusobacterium            weight per day,
                                                  necrophorum and          depending on the
                                                  Arcanobacterium          severity of the
                                                  pyogenes; for            coccidiosis
                                                  prevention and control   challenge, up to 480
                                                  of coccidiosis caused    mg/head/day and 60 to
                                                  by Eimeria bovis and E   90 mg/head/day
                                                  zuernii; and for         tylosin for the last
                                                  increased rate of        28 to 42 days on
                                                  weight gain and          feed. A withdrawal
                                                  improved feed            time has not been
                                                  efficiency in cattle     established for pre-
                                                  fed in confinement for   ruminating calves. Do
                                                  slaughter for the last   not use in calves to
                                                  28 to 42 days on feed.   be processed for
                                                                           veal. Tylosin
                                                                           provided by Nos.
                                                                           016592 or 058198;
                                                                           monensin as provided
                                                                           by No. 058198;
                                                                           ractopamine provided
                                                                           by Nos. 054771 or
                                                                           058198 in Sec.
                                                                           510.600(c) of this
                                                                           chapter.
(ix) 8 to 10...............  Monensin, 10 to 40  Cattle fed in            Feed a minimum of 1.0           054771
                              plus ractopamine,   confinement for          lb/head/day                    058198
                              not to exceed 800.  slaughter: For           ractopamine Type C
                                                  reduction of incidence   top dress feed
                                                  of liver abscesses       continuously to
                                                  caused by                cattle fed in
                                                  Fusobacterium            confinement for
                                                  necrophorum and          slaughter, to provide
                                                  Arcanobacterium          70 to 400 mg/head/day
                                                  pyogenes; for            ractopamine for the
                                                  prevention and control   last 28 to 42 days on
                                                  of coccidiosis caused    feed. Feed on top of
                                                  by Eimeria bovis and E   a ration containing
                                                  zuernii; and for         10 to 40 g/ton
                                                  increased rate of        monensin and 8 to 10
                                                  weight gain and          g/ton tylosin
                                                  improved feed            phosphate, to provide
                                                  efficiency in cattle     0.14 to 0.42 mg
                                                  fed in confinement for   monensin/lb body
                                                  slaughter for the last   weight/day, depending
                                                  28 to 42 days on feed.   on the severity of
                                                                           the coccidiosis
                                                                           challenge, up to 480
                                                                           mg/head/day and 60 to
                                                                           90 mg/head/day
                                                                           tylosin. A withdrawal
                                                                           time has not been
                                                                           established for pre-
                                                                           ruminating calves. Do
                                                                           not use in calves to
                                                                           be processed for
                                                                           veal. Tylosin
                                                                           provided by Nos.
                                                                           016592 or 058198;
                                                                           monensin as provided
                                                                           by No. 058198;
                                                                           ractopamine provided
                                                                           by Nos. 054771 or
                                                                           058198 in Sec.
                                                                           510.600(c) of this
                                                                           chapter.

[[Page 95020]]

 
(x) 8 to 10................  Monensin 10 to 40   Cattle fed in            Feed continuously as            054771
                              plus ractopamine    confinement for          sole ration to                 058198
                              9.8 to 24.6.        slaughter: For           provide 90 to 430 mg/
                                                  reduction of incidence   head/day ractopamine
                                                  of liver abscesses       and 0.14 to 0.42 mg
                                                  caused by                monensin/lb body
                                                  Fusobacterium            weight per day,
                                                  necrophorum and          depending on the
                                                  Arcanobacterium          severity of the
                                                  pyogenes; for            coccidiosis
                                                  prevention and control   challenge, up to 480
                                                  of coccidiosis caused    mg/head/day and 60 to
                                                  by Eimeria bovis and E   90 mg/head/day
                                                  zuernii; and for         tylosin for the last
                                                  increased rate of        28 to 42 days on
                                                  weight gain, improved    feed. A withdrawal
                                                  feed efficiency, and     time has not been
                                                  increased carcass        established for pre-
                                                  leanness in cattle fed   ruminating calves. Do
                                                  in confinement for       not use in calves to
                                                  slaughter for the last   be processed for
                                                  28 to 42 days on feed.   veal. Tylosin
                                                                           provided by Nos.
                                                                           016592 or 058198;
                                                                           monensin as provided
                                                                           by No. 058198;
                                                                           ractopamine as
                                                                           provided by Nos.
                                                                           054771 or 058198 in
                                                                           Sec.   510.600(c) of
                                                                           this chapter.
(xi) 8 to 10...............  Monensin, 10 to 40  Heifers fed in           Feed continuously as            054771
                              plus ractopamine,   confinement for          sole ration to                 058198
                              9.8 to 24.6 plus    slaughter: For           provide 90 to 430 mg/
                              melengestrol,       reduction of incidence   head/day ractopamine
                              0.125 to 1 mg/lb.   of liver abscesses       and 0.14 to 0.42 mg
                                                  caused by                monensin/lb body
                                                  Fusobacterium            weight per day,
                                                  necrophorum and          depending on the
                                                  Arcanobacterium          severity of the
                                                  (Actinomyces)            coccidiosis
                                                  pyogenes; for            challenge, up to 480
                                                  prevention and control   mg/head/day and 60 to
                                                  of coccidiosis caused    90 mg/head/day
                                                  by Eimeria bovis and E   tylosin for the last
                                                  zuernii; for increased   28 to 42 days on
                                                  rate of weight gain,     feed. Feed
                                                  improved feed            melengestrol as a top
                                                  efficiency, and          dress or mixed with a
                                                  increased carcass        complete ration at
                                                  leanness; and            the rate of 0.5 to
                                                  suppression of estrus    2.0 pound/head/day
                                                  (heat).                  (specify one level)
                                                                           to provide 0.25 to
                                                                           0.5 mg melengestrol
                                                                           acetate/head/day
                                                                           (specify one level).
                                                                           A withdrawal time has
                                                                           not been established
                                                                           for pre-ruminating
                                                                           calves. Do not use in
                                                                           calves to be
                                                                           processed for veal.
                                                                           Tylosin provided by
                                                                           Nos. 016592 or
                                                                           058198; monensin as
                                                                           provided by No.
                                                                           058198; ractopamine
                                                                           as provided by Nos.
                                                                           054771 or 058198 in
                                                                           Sec.   510.600(c) of
                                                                           this chapter.
(xii) 8 to 10..............  Monensin, 10 to 40  Cattle fed in            Feed continuously as            000061
                              plus zilpaterol,    confinement for          the sole ration to             016592
                              6.8.                slaughter: For           cattle during the
                                                  reduction of incidence   last 20 to 40 days on
                                                  of liver abscesses       feed to provide 60 to
                                                  caused by                90 mg/head/day
                                                  Fusobacterium            zilpaterol, 0.14 to
                                                  necrophorum and          0.42 mg/lb body
                                                  Arcanobacterium          weight/day monensin,
                                                  pyogenes; for            depending on the
                                                  prevention and control   severity of the
                                                  of coccidiosis caused    coccidiosis
                                                  by Eimeria bovis and E   challenge, up to 480
                                                  zuernii; and for         mg/head/day monensin,
                                                  increased rate of        and 60 to 90 mg/head/
                                                  weight gain, improved    day tylosin. Do not
                                                  feed efficiency, and     use in veal calves.
                                                  increased carcass        Withdrawal period 3
                                                  leanness in cattle fed   days. Tylosin
                                                  in confinement for       provided by Nos.
                                                  slaughter for the last   016592 or 058198;
                                                  20 to 40 days on feed.   monensin as provided
                                                                           by No. 058198;
                                                                           zilpaterol as
                                                                           provided by No.
                                                                           000061 in Sec.
                                                                           510.600(c) of this
                                                                           chapter.
(xiii) 8 to 10.............  Monensin, 10 to 40  Cattle fed in            Feed this component             000061
                              plus zilpaterol,    confinement for          feed continuously to           016592
                              6.8 to 24.          slaughter: For           cattle during the
                                                  reduction of incidence   last 20 to 40 days on
                                                  of liver abscesses       feed to provide 60 mg/
                                                  caused by                head/day zilpaterol,
                                                  Fusobacterium            0.14 to 0.42 mg/lb
                                                  necrophorum and          body weight/day
                                                  Arcanobacterium          monensin, depending
                                                  pyogenes; for            on the severity of
                                                  prevention and control   the coccidiosis
                                                  of coccidiosis caused    challenge, up to 480
                                                  by Eimeria bovis and E   mg/head/day monensin,
                                                  zuernii; and for         and 60 to 90 mg/head/
                                                  increased rate of        day tylosin. Do not
                                                  weight gain, improved    use in veal calves.
                                                  feed efficiency, and     Withdrawal period 3
                                                  increased carcass        days. Tylosin
                                                  leanness in cattle fed   provided by Nos.
                                                  in confinement for       016592 or 058198;
                                                  slaughter for the last   monensin as provided
                                                  20 to 40 days on feed.   by No. 058198;
                                                                           zilpaterol as
                                                                           provided by No.
                                                                           000061 in Sec.
                                                                           510.600(c) of this
                                                                           chapter.

[[Page 95021]]

 
(xiv) 8 to 10..............  Monensin, 10 to 40  Heifers fed in           Feed continuously as            000061
                              plus zilpaterol,    confinement for          the sole ration to             016592
                              6.8 plus            slaughter: For           cattle during the              058198
                              melengestrol,       reduction of incidence   last 20 to 40 days on
                              0.125 to 1 mg/lb.   of liver abscesses       feed to provide 60 to
                                                  caused by                90 mg/head/day
                                                  Fusobacterium            zilpaterol, 0.14 to
                                                  necrophorum and          0.42 mg/lb body
                                                  Arcanobacterium          weight/day monensin,
                                                  (Actinomyces)            depending on the
                                                  pyogenes; for            severity of the
                                                  prevention and control   coccidiosis
                                                  of coccidiosis caused    challenge, up to 480
                                                  by Eimeria bovis and E   mg/head/day monensin,
                                                  zuernii; and for         and 60 to 90 mg/head/
                                                  increased rate of        day tylosin. Feed
                                                  weight gain, improved    melengestrol as a top
                                                  feed efficiency, and     dress or mixed with a
                                                  increased carcass        complete ration at
                                                  leanness in cattle fed   the rate of 0.5 to
                                                  in confinement for       2.0 pound/head/day
                                                  slaughter for the last   (specify one level)
                                                  20 to 40 days on feed;   to provide 0.25 to
                                                  and for suppression of   0.5 mg melengestrol
                                                  estrus (heat).           acetate/head/day
                                                                           (specify one level).
                                                                           Do not use in veal
                                                                           calves. Withdrawal
                                                                           period 3 days.
                                                                           Tylosin as provided
                                                                           by Nos. 016592 or
                                                                           058198; monensin as
                                                                           provided by No.
                                                                           058198; zilpaterol as
                                                                           provided by No.
                                                                           000061; melengestrol
                                                                           provided by Nos.
                                                                           054771 or 058198 in
                                                                           Sec.   510.600(c) of
                                                                           this chapter.
(xv) 8 to 10...............  Monensin, 10 to 40  Heifers fed in           Feed this component             000061
                              plus zilpaterol,    confinement for          feed continuously to           016592
                              6.8 to 24 plus      slaughter: For           cattle during the              058198
                              melengestrol,       reduction of incidence   last 20 to 40 days on
                              0.125 to 1 mg/lb.   of liver abscesses       feed to provide 60 mg/
                                                  caused by                head/day zilpaterol,
                                                  Fusobacterium            0.14 to 0.42 mg/lb
                                                  necrophorum and          body weight/day
                                                  Arcanobacterium          monensin, depending
                                                  (Actinomyces)            on the severity of
                                                  pyogenes; for            the coccidiosis
                                                  prevention and control   challenge, up to 480
                                                  of coccidiosis caused    mg/head/day monensin,
                                                  by Eimeria bovis and E   and 60 to 90 mg/head/
                                                  zuernii; and for         day tylosin. Feed
                                                  increased rate of        melengestrol as a top
                                                  weight gain, improved    dress or mixed with a
                                                  feed efficiency, and     complete ration at
                                                  increased carcass        the rate of 0.5 to
                                                  leanness in cattle fed   2.0 pound/head/day
                                                  in confinement for       (specify one level)
                                                  slaughter for the last   to provide 0.25 to
                                                  20 to 40 days on feed;   0.5 mg melengestrol
                                                  and for suppression of   acetate/head/day
                                                  estrus (heat).           (specify one level).
                                                                           Do not use in veal
                                                                           calves. Withdrawal
                                                                           period 3 days.
                                                                           Tylosin as provided
                                                                           by Nos. 016592 or
                                                                           058198; monensin as
                                                                           provided by No.
                                                                           058198; zilpaterol as
                                                                           provided by No.
                                                                           000061; melengestrol
                                                                           provided by Nos.
                                                                           054771 or 058198 in
                                                                           Sec.   510.600(c) of
                                                                           this chapter.
----------------------------------------------------------------------------------------------------------------


0
40. Revise Sec.  558.630 to read as follows:


Sec.  558.630   Tylosin and sulfamethazine.

    (a) Specifications. Type A medicated articles containing equal 
amounts of tylosin phosphate and sulfamethazine, available in 
concentrations of 5, 10, 20, or 40 grams each, per pound.
    (b) Sponsors. See sponsor numbers in Sec.  510.600(c) of this 
chapter.
    (1) No. 058198 for use as in paragraph (e)(1) of this section.
    (2) No. 054771: 10 or 40 grams per pound each for use as in 
paragraph (e)(2) of this section.
    (c) Related tolerances. See Sec. Sec.  556.670 and 556.740 of this 
chapter.
    (d) Special considerations--(1) Federal law restricts medicated 
feed containing this veterinary feed directive (VFD) drug to use by or 
on the order of a licensed veterinarian. See Sec.  558.6 for additional 
requirements.
    (2) The expiration date of VFDs for tylosin and sulfamethazine 
medicated feeds must not exceed 6 months from the date of issuance. 
VFDs for tylosin and sulfamethazine shall not be refilled.
    (3) Labeling shall bear the statement: ``Do not use in medicated 
feeds containing in excess of 2% bentonite.''
    (e) Conditions of use. It is used in feed for swine as follows:

[[Page 95022]]



----------------------------------------------------------------------------------------------------------------
   Tylosin phosphate and       Combination in
sulfamethazine in grams/ton       grams/ton        Indications for use          Limitations          Sponsors
----------------------------------------------------------------------------------------------------------------
(1) 100 each...............  ..................  For reduction in the     Withdraw 15 days                058198
                                                  severity of effects of   before swine are
                                                  atrophic rhinitis;       slaughtered.
                                                  lowering the incidence
                                                  and severity of
                                                  Bordetella
                                                  bronchiseptica
                                                  rhinitis; prevention
                                                  of swine dysentery
                                                  associated with
                                                  Brachyspira
                                                  hyodysenteriae;
                                                  control of swine
                                                  pneumonias caused by
                                                  bacterial pathogens
                                                  (Pasteurella multocida
                                                  and/or Arcanobacterium
                                                  pyogenes); reducing
                                                  the incidence of
                                                  cervical lymphadenitis
                                                  (jowl abscesses)
                                                  caused by Group E
                                                  Streptococci. Only the
                                                  sulfamethazine portion
                                                  of this combination is
                                                  active in controlling
                                                  jowl abscesses.
(2) 100 each...............  ..................  For reduction in the     Withdraw 15 days                054771
                                                  severity of effects of   before swine are
                                                  atrophic rhinitis;       slaughtered.
                                                  lowering the incidence
                                                  and severity of
                                                  Bordetella
                                                  bronchiseptica
                                                  rhinitis; prevention
                                                  of swine dysentery
                                                  associated with
                                                  Brachyspira
                                                  hyodysenteriae; and
                                                  control of swine
                                                  pneumonias caused by
                                                  bacterial pathogens
                                                  (Pasteurella multocida
                                                  and/or Arcanobacterium
                                                  pyogenes).
----------------------------------------------------------------------------------------------------------------


0
41. Revise Sec.  558.635 to read as follows:


Sec.  558.635  Virginiamycin.

    (a) Specifications. Type A medicated articles containing 5, 10, 20, 
50, 136.2, or 227 grams per pound virginiamycin.
    (b) Sponsors. See No. 066104 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec.  556.750 of this chapter.
    (d) Special considerations--(1) [Reserved]
    (2) [Reserved]
    (3) Not for use in breeding swine over 120 pounds.
    (4) Dilute Type A article with at least 10 pounds of a feed 
ingredient prior to final mixing in 1 ton of Type C feed.
    (e) Conditions of use--(1) Chickens--

----------------------------------------------------------------------------------------------------------------
                               Combination in
  Virginiamycin grams/ton         grams/ton        Indications for use          Limitations          Sponsors
----------------------------------------------------------------------------------------------------------------
(i) 5......................  ..................  Broiler chickens: For    Not for use in layers.          066104
                                                  increased rate of
                                                  weight gain and
                                                  improved feed
                                                  efficiency.
(ii) 5.....................  Monensin, 90 to     Broiler chickens: For    Feed continuously as            066104
                              110.                increased rate of        the sole ration. Do
                                                  weight gain and          not feed to laying
                                                  improved feed            chickens.
                                                  efficiency; as an aid    Virginiamycin as
                                                  in the prevention of     provided by No.
                                                  coccidiosis caused by    066104; monensin as
                                                  Eimeria necatrix, E.     provided by No.
                                                  tenella, E.              058198 in Sec.
                                                  acervulina, E.           510.600(c) of this
                                                  brunetti, E. maxima,     chapter.
                                                  and E. mivati.
(iii) 5....................  Salinomycin, 40 to  Broiler chickens: For    Feed continuously as            066104
                              60.                 increased rate of        the sole ration. Do            016592
                                                  weight gain and          not feed to layers or
                                                  improved feed            to chickens over 16
                                                  efficiency; for          weeks of age. Not
                                                  prevention of            approved for use with
                                                  coccidiosis caused by    pellet binders. May
                                                  Eimeria tenella, E.      be fatal if
                                                  necatrix, E.             accidentally fed to
                                                  acervulina, E. maxima,   adult turkeys or
                                                  E. brunetti, and E.      horses. Virginiamycin
                                                  mivati.                  as provided by No.
                                                                           066104; salinomycin
                                                                           as provided by No.
                                                                           054771 in Sec.
                                                                           510.600(c) of this
                                                                           chapter.
(iv) 5.....................  Semduramicin, 22.7  Broiler chickens: For    Feed continuously as            066104
                                                  increased rate of        the sole ration. Do
                                                  weight gain and          not feed to laying
                                                  improved feed            hens. Semduramicin as
                                                  efficiency; for the      provided by No.
                                                  prevention of            066104 in Sec.
                                                  coccidiosis caused by    510.600(c) of this
                                                  Eimeria acervulina, E.   chapter.
                                                  brunetti, E. maxima,
                                                  E. mivati/mitis, E.
                                                  necatrix, and E.
                                                  tenella.
(v) 5......................  Semduramicin        Broiler chickens: For    Feed continuously as            066104
                              (biomass), 22.7.    increased rate of        the sole ration.
                                                  weight gain and          Withdraw 1 day before
                                                  improved feed            slaughter. Do not
                                                  efficiency; for the      feed to laying hens.
                                                  prevention of            Virginiamycin and
                                                  coccidiosis caused by    semduramicin as
                                                  Eimeria acervulina, E.   provided by No.
                                                  brunetti, E. maxima,     066104 in Sec.
                                                  E. mivati/mitis, E.      510.600(c) of this
                                                  necatrix, and E.         chapter.
                                                  tenella.
(vi) 5 to 15...............                      Broiler chickens: For    Not for use in layers.          066104
                                                  increased rate of
                                                  weight gain.

[[Page 95023]]

 
(vii) 5 to 15..............  Amprolium, 113.5    Broiler chickens: For    Feed continuously as            066104
                              and ethopabate,     increased rate of        the sole ration and
                              36.3.               weight gain; as an aid   as the sole source of
                                                  in the prevention of     amprolium. Do not
                                                  coccidiosis where        feed to laying
                                                  severe exposure to       chickens. Not for
                                                  coccidiosis from         chickens over 16
                                                  Eimeria acervulina, E.   weeks of age.
                                                  maxima, and E.           Virginiamycin as
                                                  brunetti is likely to    provided by No.
                                                  occur.                   066104; amprolium and
                                                                           ethopabate as
                                                                           provided by No.
                                                                           016592 in Sec.
                                                                           510.600(c) of this
                                                                           chapter.
(viii) 5 to 15.............  Monensin, 90 to     Broiler chickens: For    Feed continuously as            066104
                              110.                increased rate of        the sole ration. Do
                                                  weight gain; as an aid   not feed to laying
                                                  in the prevention of     chickens. Monensin as
                                                  coccidiosis caused by    provided by No.
                                                  Eimeria necatrix, E.     000986 in Sec.
                                                  tenella, E.              510.600(c) of this
                                                  acervulina, E.           chapter.
                                                  brunetti, E. maxima,
                                                  and E. mivati.
(ix) 5 to 15...............  Salinomycin, 40 to  Broiler chickens: For    Feed continuously as            016592
                              60.                 increased rate of        the sole ration. Do            066104
                                                  weight gain; as an aid   not feed to layers or
                                                  in the prevention of     to chickens over 16
                                                  coccidiosis caused by    weeks of age. Not
                                                  Eimeria tenella, E.      approved for use with
                                                  necatrix, E.             pellet binders. May
                                                  acervulina, E. maxima,   be fatal if
                                                  E. brunetti, and E.      accidentally fed to
                                                  mivati.                  adult turkeys or
                                                                           horses. Virginiamycin
                                                                           as provided by No.
                                                                           066104; salinomycin
                                                                           as provided by Nos.
                                                                           016592 or 054771 in
                                                                           Sec.   510.600(c) of
                                                                           this chapter.
(x) 5 to 15................  Semduramicin, 22.7  Broiler chickens: For    Feed continuously as            066104
                                                  increased rate of        the sole ration. Do
                                                  weight gain; for the     not feed to laying
                                                  prevention of            hens. Semduramicin as
                                                  coccidiosis caused by    provided by No.
                                                  Eimeria acervulina, E.   066104 in Sec.
                                                  brunetti, E. maxima,     510.600(c) of this
                                                  E. mivati/mitis, E.      chapter.
                                                  necatrix, and E.
                                                  tenella.
(xi) 5 to 15...............  Semduramicin        Broiler chickens: For    Feed continuously as            066104
                              (biomass), 22.7.    increased rate of        the sole ration.
                                                  weight gain; for the     Withdraw 1 day before
                                                  prevention of            slaughter. Do not
                                                  coccidiosis caused by    feed to laying hens.
                                                  Eimeria acervulina, E.   Virginiamycin as
                                                  brunetti, E. maxima, E   provided by No.
                                                  mivati/mitis, E.         066104; semduramicin
                                                  necatrix, and E.         as provided by No.
                                                  tenella.                 066104 in Sec.
                                                                           510.600(c) of this
                                                                           chapter.
(xii) 15...................  Amprolium, 113.5    Broiler chickens: For    Feed continuously as            066104
                              and ethopabate,     increased rate of        the sole ration and
                              36.3.               weight gain and          as the sole source of
                                                  improved feed            amprolium. Do not
                                                  efficiency; as an aid    feed to laying
                                                  in the prevention of     chickens. Not for
                                                  coccidiosis where        chickens over 16
                                                  severe exposure to       weeks of age.
                                                  coccidiosis from         Virginiamycin as
                                                  Eimeria acervulina, E.   provided by No.
                                                  maxima, and E.           066104; amprolium and
                                                  brunetti is likely to    ethopabate as
                                                  occur.                   provided by No.
                                                                           016592 in Sec.
                                                                           510.600(c) of this
                                                                           chapter.
(xiii) 20..................                      Broiler chickens: For    Not for use in layers.          066104
                                                  prevention of necrotic
                                                  enteritis caused by
                                                  Clostridium spp.
                                                  susceptible to
                                                  virginiamycin.
(xiv) 20...................  Lasalocid, 68 to    Broiler chickens: For    Feed continuously as            066104
                              113.                increased rate of        the sole ration. Do
                                                  weight gain and          not feed to laying
                                                  improved feed            chickens. Lasalocid
                                                  efficiency; for          sodium as provided by
                                                  prevention of            No. 054771 in Sec.
                                                  coccidiosis caused by    510.600(c) of this
                                                  Eimeria tenella, E.      chapter.
                                                  necatrix, E.
                                                  acervulina, E.
                                                  brunetti, E. mivati,
                                                  and E. maxima.
(xv) 20....................  Monensin, 90 to     Broiler chickens: For    Feed continuously as            066104
                              110.                prevention of necrotic   the sole ration. Do
                                                  enteritis caused by      not feed to laying
                                                  Clostridium spp.         chickens. Monensin as
                                                  susceptible to           provided by No.
                                                  virginiamycin; and as    058198 in Sec.
                                                  an aid in the            510.600(c) of this
                                                  prevention of            chapter.
                                                  coccidiosis caused by
                                                  Eimeria necatrix, E.
                                                  tenella, E.
                                                  acervulina, E.
                                                  brunetti, E. maxima,
                                                  and E. mivati.
(xvi) 20...................  Semduramicin, 22.7  Broiler chickens: For    Feed continuously as            066104
                                                  prevention of necrotic   the sole ration. Do
                                                  enteritis caused by      not feed to laying
                                                  Clostridium spp.         hens. Semduramicin as
                                                  susceptible to           provided by No.
                                                  virginiamycin; for the   066104 in Sec.
                                                  prevention of            510.600(c) of this
                                                  coccidiosis caused by    chapter.
                                                  Eimeria acervulina, E.
                                                  brunetti, E. maxima,
                                                  E. mivati/mitis, E.
                                                  necatrix, and E.
                                                  tenella.
(xvii) 20..................  Semduramicin        Broiler chickens: For    Feed continuously as            066104
                              (biomass), 22.7.    prevention of necrotic   the sole ration.
                                                  enteritis caused by      Withdraw 1 day before
                                                  Clostridium spp.         slaughter. Do not
                                                  susceptible to           feed to laying hens.
                                                  virginiamycin; for the   Semduramicin as
                                                  prevention of            provided by No.
                                                  coccidiosis caused by    066104 in Sec.
                                                  Eimeria acervulina, E.   510.600(c) of this
                                                  brunetti, E. maxima,     chapter.
                                                  E. mivati/mitis, E.
                                                  necatrix, and E.
                                                  tenella.
----------------------------------------------------------------------------------------------------------------


[[Page 95024]]

    (2) Turkeys--

----------------------------------------------------------------------------------------------------------------
                               Combination in
  Virginiamycin grams/ton         grams/ton        Indications for use          Limitations          Sponsors
----------------------------------------------------------------------------------------------------------------
(i) 10 to 20...............  ..................  Growing turkeys: For     Not for use in layers.          066104
                                                  increased rate of
                                                  weight gain and
                                                  improved feed
                                                  efficiency.
(ii) 10 to 20..............  Lasalocid, 68 to    Growing turkeys: For     Lasalocid sodium as             054771
                              113.                increased rate of        provided by No.
                                                  weight gain and          054771 in Sec.
                                                  improved feed            510.600(c) of this
                                                  efficiency; and for      chapter.
                                                  the prevention of
                                                  coccidiosis caused by
                                                  Eimeria meleagrimitis,
                                                  E. gallopavonis, and
                                                  E. adenoeides.
(iii) 10 to 20.............  Monensin, 90 to     Growing turkeys: For     Monensin as provided            066104
                              110.                increased rate of        by No. 058198 in Sec.
                                                  weight gain and            510.600(c) of this
                                                  improved feed            chapter.
                                                  efficiency; and for
                                                  the prevention of
                                                  coccidiosis caused by
                                                  Eimeria meleagrimitis,
                                                  E. gallopavonis, and
                                                  E. adenoeides.
----------------------------------------------------------------------------------------------------------------

    (3) Swine--

----------------------------------------------------------------------------------------------------------------
                               Combination in
  Virginiamycin grams/ton         grams/ton        Indications for use          Limitations          Sponsors
----------------------------------------------------------------------------------------------------------------
(i) 5 or 10................  ..................  Growing-finishing        Feed continuously from          066104
                                                  swine: For increased     weaning to market
                                                  rate of weight gain      weight. Feed 10 grams
                                                  and improved feed        per ton from weaning
                                                  efficiency.              up to 120 pounds,
                                                                           followed by 5 grams
                                                                           per ton to market
                                                                           weight.
(ii) 5 to 10...............  ..................  Growing-finishing        Feed continuously from          066104
                                                  swine: For increased     weaning to market
                                                  rate of weight gain.     weight. Feed 10 grams
                                                                           per ton from weaning
                                                                           up to 120 pounds for
                                                                           increased rate of
                                                                           weight gain and
                                                                           improved feed
                                                                           efficiency, followed
                                                                           by 5 to 10 grams per
                                                                           ton to market weight
                                                                           for increased rate of
                                                                           weight gain.
(iii) 25...................  ..................  Growing-finishing        ......................          066104
                                                  swine: As an aid in
                                                  control of dysentery
                                                  in swine up to 120
                                                  pounds in animals or
                                                  on premises with a
                                                  history of swine
                                                  dysentery but where
                                                  symptoms have not yet
                                                  occurred.
(iv) 50 or 100.............  ..................  Growing-finishing        Feed 100 grams per ton          066104
                                                  swine: For treatment     for 2 weeks, 50 grams
                                                  and control of swine     per ton thereafter.
                                                  dysentery in swine up
                                                  to 120 pounds.
(v) 100....................  ..................  Growing-finishing        Feed for 2 weeks......          066104
                                                  swine: For treatment
                                                  of swine dysentery in
                                                  nonbreeding swine over
                                                  120 pounds.
----------------------------------------------------------------------------------------------------------------

    (4) Cattle--

----------------------------------------------------------------------------------------------------------------
                               Combination in
  Virginiamycin grams/ton         grams/ton        Indications for use          Limitations          Sponsors
----------------------------------------------------------------------------------------------------------------
(i) 11.0 to 16.0...........  ..................  Cattle fed in            Feed continuously as            066104
                                                  confinement for          the sole ration to
                                                  slaughter: For           provide 70 to 240
                                                  improved feed            milligrams per head
                                                  efficiency.              per day. Not for use
                                                                           in animals intended
                                                                           for breeding.
(ii) 13.5 to 16.0..........  ..................  Cattle fed in            Feed continuously as            066104
                                                  confinement for          the sole ration to
                                                  slaughter: For           provide 85 to 240
                                                  reduction of incidence   milligrams per head
                                                  of liver abscesses.      per day. Not for use
                                                                           in animals intended
                                                                           for breeding.
(iii) 16.0 to 22.5.........  ..................  Cattle fed in            Feed continuously as            066104
                                                  confinement for          the sole ration to
                                                  slaughter: For           provide 100 to 340
                                                  increased rate of        milligrams per head
                                                  weight gain.             per day. Not for use
                                                                           in animals intended
                                                                           for breeding.
----------------------------------------------------------------------------------------------------------------


[[Page 95025]]


0
42. In Sec.  558.665, remove and reserve paragraphs (e)(5) and (6); 
remove paragraphs (e)(11) and (12); and add paragraph (f) to read as 
follows:


Sec.  558.665  Zilpaterol.

* * * * *
    (f) Zilpaterol may also be used in combination with tylosin as in 
Sec.  558.625.

0
43. In Sec.  558.680, remove paragraph (d)(1)(x); and add paragraph 
(e)(3) to read as follows:


Sec.  558.680  Zoalene.

* * * * *
    (e) * * *
    (3) Zoalene may also be used in combination with lincomycin as in 
Sec.  558.325.

    Dated: December 20, 2016.
Tracey H. Forfa,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. 2016-31083 Filed 12-23-16; 8:45 am]
BILLING CODE 4164-01-P

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