| Page Range | 94991-95025 | |
| FR Document | 2016-31083 |
[Federal Register Volume 81, Number 248 (Tuesday, December 27, 2016)] [Rules and Regulations] [Pages 94991-95025] From the Federal Register Online [www.thefederalregister.org] [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, [email protected]. 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 (http://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
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Final rule; technical amendment. | |
| Dates | This rule is effective December 30, 2016. | |
| Contact | George K. Haibel, Center for Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5689, [email protected] | |
| FR Citation | 81 FR 94991 | |
| CFR Citation | 21
CFR
556 21 CFR 558 | |
| CFR Associated | Animal Drugs; Foods and Animal Feeds |