2016-31083. New Animal Drugs for Use in Animal Feed; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications
-
Start Preamble
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.
Start Further InfoFOR FURTHER INFORMATION CONTACT:
George K. Haibel, Center for Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5689, george.haibel@fda.hhs.gov.
End Further Info End Preamble Start Supplemental InformationSUPPLEMENTARY 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% (sulfaquinoxaline) Type A Medicated Article Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str., 1113 Sophia, Bulgaria (Huvepharma EOOD). 008-804 TM-50 or TM-100 (oxytetracycline) Type A Medicated Article Phibro Animal Health Corp., GlenPointe Centre East, 3d Floor, 300 Frank W. Burr Blvd., Suite 21, Teaneck, NJ 07666 (Phibro Animal Health Corp.). 010-092 GALLIMYCIN-100P (erythromycin) Type A Medicated Article Cross Vetpharm Group Ltd., Broomhill Rd., Tallaght, Dublin 24, Ireland (Cross Vetpharm Group Ltd.). 010-918 HYGROMIX 8 (hygromycin B) Type A Medicated Article Elanco US Inc., 2500 Innovation Way, Greenfield, IN 46140 (Elanco US Inc.). 012-491 TYLAN (tylosin) Type A Medicated Article Elanco US Inc. 033-950 Sulfamerazine In Fish Grade Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007 (Zoetis Inc.). 035-688 AUREOMIX S 40/40 (chlortetracycline and sulfamethazine) Granular Type A Medicated Article Zoetis Inc. 035-805 AUREO S 700 (chlortetracycline and sulfamethazine) Granular Type A Medicated Article Zoetis Inc. 038-439 TERRAMYCIN 200 (oxytetracycline) for Fish Type A Medicated Article Phibro Animal Health Corp. 040-209 ROFENAID 40 (sulfadimethoxine and ormetoprim) Type A Medicated Article Zoetis Inc. Start Printed Page 94992 041-275 TYLAN 40 Sulfa-G (tylosin and sulfamethazine) Type A Medicated Article Elanco US Inc. 041-647 AUREOMIX S 700-A (chlortetracycline and sulfamethazine) Type A Medicated Article Zoetis Inc. 041-648 AUREOMIX S 700-D (chlortetracycline and sulfamethazine) Type A Medicated Article Zoetis Inc. 041-649 AUREOMIX S 700-G (chlortetracycline and sulfamethazine) Type A Medicated Article Zoetis Inc. 041-650 AUREOMIX S 700-E (chlortetracycline and sulfamethazine) Type A Medicated Article Zoetis Inc. 041-651 AUREOMIX S 700-F (chlortetracycline and sulfamethazine) Type A Medicated Article Zoetis Inc. 041-652 AUREOMIX S 700-C-2 (chlortetracycline and sulfamethazine) Type A Medicated Article Zoetis Inc. 041-653 AUREOMIX S 700-B (chlortetracycline and sulfamethazine) Type A Medicated Article Zoetis Inc. 041-654 AUREOMIX S 700-H (chlortetracycline and sulfamethazine) Type A Medicated Article Zoetis Inc. 046-415 Tylosin Type A Medicated Article Zoetis Inc. 046-699 CHLORMAX (chlortetracycline) Type A Medicated Article Zoetis Inc. 048-480 CHLORATET (chlortetracycline) Type A Medicated Article Pharmgate LLC, 1015 Ashes Dr., Suite 102, Wilmington, NC 28405 (Pharmgate LLC). 048-761 AUREOMYCIN (chlortetracycline) Type A Medicated Article Zoetis Inc. 049-287 CHLORACHEL (chlortetracycline)Type A Medicated Article Zoetis Inc. 091-749 TYLAN 40 Plus Sulfa-G (tylosin and sulfamethazine) Type A Medicated Article Zoetis Inc. 092-286 CLTC-50 MR (chlortetracycline) Type A Medicated Article Phibro Animal Health Corp. 092-287 CLTC 100 MR (chlortetracycline) Type A Medicated Article Phibro Animal Health Corp. 094-975 NEO-TERRAMYCIN 100/100 (oxytetracycline and neomycin) Type A Medicated Article Phibro Animal Health Corp. 095-143 TERRAMYCIN 10, 30, 50, 100, or 200 (oxytetracycline) Type A Medicated Article Phibro Animal Health Corp. 097-505 LINCOMIX 20 (lincomycin) Type A Medicated Article Zoetis Inc. 098-431 TYLAN 10 (tylosin) Premix Type A Medicated Article Phibro Animal Health Corp. 100-901 PFICHLOR 100S (chlortetracycline) Milk Replacer Type A Medicated Article Zoetis Inc. 125-933 ROMET-30 (ormetoprim and sulfadimethoxine) Type A Medicated Article Pharmaq AS. 126-050 APRALAN 75 (apramycin) Type A Medicated Article Elanco US Inc. 138-934 PENNCHLOR S 40/40 (chlortetracycline and sulfamethazine) Type A medicated article Pharmgate LLC. 138-935 PENNCHLOR 100 MR (chlortetracycline) Type A Medicated Article Pharmgate LLC. 138-938 PENNOX 50, 100, or 200 Hi-Flo, or 100-MR (oxytetracycline) Type A Medicated Article Pharmgate LLC. 138-939 NEO-OXY 100/100 MR (oxytetracycline and neomycin) Type A Medicated Article Pharmgate LLC. 140-976 NEOMIX 325 Milk Replacer (neomycin) Type A Medicated Article Zoetis Inc. 200-314 PENNCHLOR S (chlortetracycline and sulfamethazine) Type A Medicated Article Pharmgate LLC. 200-484 TYLOVET 100 (tylosin) Type A Medicated Article Huvepharma. 200-510 DERACIN 100 (chlortetracycline) Type A Medicated Article Pharmgate LLC. The affected applications for manufacturing combination drug medicated feeds follow:
File No. Animal drug product Sponsor 036-361 CTC Sodium Sulfate (chlortetracycline and sodium sulfate)/AMPROL PLUS (amprolium and ethopabate) Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007 (Zoetis Inc.). 045-444 CHLORMAX (chlortetracycline)/DECCOX (decoquinate) Zoetis Inc. 046-209 CTC (chlortetracycline)/COYDEN (clopidol) Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str., 1113 Sophia, Bulgaria (Huvepharma EOOD). 092-507 AUREOMYCIN (chlortetracycline)/ROBENZ (robenidine) Zoetis Inc. 099-006 TERRAMYCIN (oxytetracycline)/COBAN (monensin) Phibro Animal Health Corp., GlenPointe Centre East, 3d Floor, 300 Frank W. Burr Blvd., Suite 21, Teaneck, NJ 07666 (Phibro Animal Health Corp.). 101-666 TERRAMYCIN (oxytetracycline)/ROBENZ (robenidine) Phibro Animal Health Corp. Start Printed Page 94993 104-646 TYLAN (tylosin)/RUMENSIN (monensin) Elanco US Inc., 2500 Innovation Way, Greenfield, IN 46140 (Elanco US Inc.). 110-047 TYLAN (tylosin)/BANMINTH (pyrantel) Phibro Animal Health Corp. 116-044 LINCOMIX (lincomycin)/BANMINTH (pyrantel) Phibro Animal Health Corp. 121-553 AUREOMYCIN (chlortetracycline)/COBAN (monensin) Zoetis Inc. 138-870 TYLAN (tylosin)/RUMENSIN (monensin)/MGA (melengestrol) Zoetis Inc. 138-941 LINCOMIX (lincomycin)/BANMINTH (pyrantel) Zoetis Inc. 138-992 TYLAN (tylosin)/BOVATEC (lasalocid)/MGA (melengestrol) Zoetis Inc. 138-995 TYLAN (tylosin)/MGA (melengestrol) Zoetis Inc. 139-192 TYLAN (tylosin)/MGA (melengestrol) Zoetis Inc. 140-448 TERRAMYCIN (oxytetracycline)/BIO-COX (salinomycin) Phibro Animal Health Corp. 140-859 AUREOMYCIN (chlortetracycline)/BIO-COX (salinomycin) Zoetis Inc. 140-954 LINCOMIX (lincomycin)/SAFE-GUARD (fenbendazole) Intervet, Inc. 141-011 CTC (chlortetracycline)/DENAGARD (tiamulin) Elanco US Inc. 141-054 LINCOMIX (lincomycin)/IVOMEC (ivermectin) Merial, Inc., 3239 Satellite Blvd., Bldg. 500, Duluth, GA 30096-4640. 141-059 CHLORMAX (chlortetracycline)/BMD (bacitracin) Zoetis Inc. 141-147 CHLORMAX (chlortetracycline)/DECCOX (decoquinate) Zoetis Inc. 141-149 TYLAN (tylosin)/RUMENSIN (monensin)/DECCOX (decoquinate) Zoetis Inc. 141-172 TYLAN (tylosin)/PAYLEAN (ractopamine) Elanco US Inc. 141-185 AUREOMYCIN (chlortetracycline)/DECCOX (decoquinate) Zoetis Inc. 141-201 AUREOMYCIN (chlortetracycline)/CATTLYST (laidlomycin) Zoetis Inc. 141-211 TERRAMYCIN (oxytetracycline)/(carbadox) Phibro Animal Health Corp. 141-224 TYLAN (tylosin)/RUMENSIN (monensin)/OPTAFLEXX (ractopamine) Elanco US Inc. 141-233 TYLAN (tylosin)/RUMENSIN (monensin)/OPTAFLEXX (ractopamine)/MGA (melengestrol) Elanco US Inc. 141-250 AUREOMYCIN (chlortetracycline)/BOVATEC (lasalocid) Zoetis Inc. 141-276 TYLAN (tylosin)/RUMENSIN (monensin)/ZILMAX (zilpaterol) Intervet, Inc., 2 Giralda Farms, Madison, NJ 07940 (Intervet, Inc.). 141-280 TYLAN (tylosin)/RUMENSIN (monensin)/ZILMAX (zilpaterol)/MGA (melengestrol) Intervet, Inc. 200-095 AUREOMYCIN (chlortetracycline)/SACOX (salinomycin) Huvepharma EOOD. 200-096 TERRAMYCIN (oxytetracycline)/SACOX (salinomycin) Huvepharma EOOD. 200-242 AUREOMYCIN (chlortetracycline)/BMD (bacitracin) Zoetis Inc. 200-261 CHLORMAX (chlortetracycline)/BIO-COX (salinomycin) Zoetis Inc. 200-262 CHLORMAX (chlortetracycline)/SACOX (salinomycin) Zoetis Inc. 200-263 CHLORMAX (chlortetracycline)/COBAN (monensin) Zoetis Inc. 200-354 PENNCHLOR (chlortetracycline)/COBAN (monensin) Pharmgate LLC, 1015 Ashes Dr., Suite 102, Wilmington, NC 28405 (Pharmgate LLC). 200-356 PENNCHLOR (chlortetracycline)/DENAGARD (tiamulin) Pharmgate LLC. 200-357 PENNCHLOR (chlortetracycline)/BIO-COX (salinomycin) Pharmgate LLC. 200-358 PENNCHLOR (chlortetracycline)/BMD (bacitracin) Pharmgate LLC. 200-359 PENNCHLOR (chlortetracycline)/DECCOX (decoquinate) Pharmgate LLC. 200-375 TYLAN (tylosin)/RUMENSIN (monensin)/HEIFERMAX (melengestrol) Elanco US Inc. 200-424 TYLAN (tylosin)/RUMENSIN (monensin)/OPTAFLEXX (ractopamine)/HEIFERMAX (melengestrol) Elanco US Inc. 200-427 TYLAN (tylosin)/HEIFERMAX 500 (melengestrol) Liquid Elanco US Inc. 200-430 TYLAN (tylosin)/BOVATEC (lasalocid)/HEIFERMAX 500 (melengestrol) Liquid Elanco US Inc. 200-480 TYLAN (tylosin)/RUMENSIN (monensin)/ZILMAX (zilpaterol)/HEIFERMAX 500 (melengestrol) Elanco US Inc. 200-530 TYLOVET (tylosin)/PAYLEAN (ractopamine) Huvepharma EOOD. 200-531 TYLOVET (tylosin)/RUMENSIN (monensin) Huvepharma EOOD. 200-532 TYLOVET (tylosin)/MGA (melengestrol) Huvepharma EOOD. 200-533 TYLOVET (tylosin)/RUMENSIN (monensin)/DECCOX (decoquinate) Huvepharma EOOD. 200-534 TYLOVET (tylosin)/RUMENSIN (monensin)/MGA (melengestrol) Huvepharma EOOD. 200-535 TYLOVET (tylosin)/BOVATEC (lasalocid)/MGA (melengestrol) Huvepharma EOOD. 200-544 TYLOVET (tylosin)/RUMENSIN (monensin)/ZILMAX (zilpaterol)/MGA (melengestrol) Huvepharma EOOD. 200-547 TYLOVET (tylosin)/RUMENSIN (monensin)/ZILMAX (zilpaterol) Huvepharma EOOD. 200-558 TYLAN (tylosin)/ENGAIN (ractopamine) Zoetis Inc. 200-561 TYLAN (tylosin)/RUMENSIN (monensin)/ACTOGAIN (ractopamine) Zoetis Inc. 200-562 TYLAN (tylosin)/RUMENSIN (monensin)/ACTOGAIN (ractopamine) Zoetis Inc. 200-566 TYLOVET (tylosin)/RUMENSIN (monensin) Huvepharma EOOD. 200-567 TYLOVET (tylosin)/RUMENSIN (monensin) Huvepharma EOOD. Start Printed Page 94994 200-583 TYLOVET (tylosin)/RUMENSIN (monensin)/ACTOGAIN (ractopamine)/MGA (melengestrol) Zoetis Inc. 200-584 TYLOVET (tylosin)/ENGAIN (ractopamine) Zoetis Inc. 200-585 TYLOVET (tylosin)/RUMENSIN (monensin)/ACTOGAIN (ractopamine) Zoetis Inc. 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 hydrochloride monohydrate) Type A Medicated Article Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007 (Zoetis Inc.). 035-287 OM-5 Premix (oleandomycin) Type A Medicated Article Phibro Animal Health Corp., GlenPointe Centre East, 3d Floor, 300 Frank W. Burr Blvd., Suite 21, Teaneck, NJ 07666 (Phibro Animal Health Corp.). 046-668 Penicillin G Procaine 50% Type A Medicated Article Phibro Animal Health Corp. 091-668 CHLORMAX-SP 500 (chlortetracycline, sulfamethazine, penicillin G procaine) Type A Medicated Article Zoetis Inc. 108-116 LINCOMIX (lincomycin)/NICARB (nicarbazin) Phibro Animal Health Corp. 133-334 Virginiamycin Type A Medicated Article Zoetis Inc. 139-473 STAFAC (virginiamycin)/STENEROL (halofuginone hydrobromide) Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str., 1113 Sophia, Bulgaria (Huvepharma EOOD). 140-340 LINCOMIX (lincomycin)/STENOROL (halofuginone hydrobromide) Huvepharma EOOD. 140-443 HYGROMIX 1.6 (hygromycin B) Type A Medicated Article Zoetis Inc. 140-947 LINCOMIX (lincomycin)/MAXIBAN (narasin and nicarbazin) Elanco US Inc., 2500 Innovation Way, Greenfield, IN 46140 (Elanco US Inc.). 141-090 STAFAC (virginiamycin)/CLINICOX (diclazuril) Huvepharma EOOD. 200-171 LINCOMIX (lincomycin)/NICARMIX (nicarbazin) Planalquimica Industrial Ltda., Rua das Magnolias nr. 2405, Jardim das Bandeiras, CEP 13053-120, Campinas, Sao Paulo, Brazil. 200-569 TYLAN (tylosin)/SACOX (salinomycin) Huvepharma EOOD. 200-570 TYLOVET 100 (tylosin)/BIO-COX (salinomycin) Huvepharma EOOD. 200-580 TYLOVET 100 (tylosin)/SACOX (salinomycin) Huvepharma EOOD. 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.
Start List of SubjectsList 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:
Start PartPART 556—TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD
End Part Start Amendment Part1. The authority citation for part 556 continues to read as follows:
End Amendment PartStart Amendment Part[Removed]2. Remove § 556.480.
End Amendment Part Start PartPART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
End Part Start Amendment Part3. The authority citation for part 558 continues to read as follows:
End Amendment Part Start Printed Page 94995 Start Amendment Part4. In § 558.4, in paragraph (d), in the Category I table, in the column headings for “Assay limits 1 percent type A” and “Assay limits percent 1 type B/C 2”, remove “type” and in its place add “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:
End Amendment PartStart Amendment PartRequirement of a medicated feed mill license.* * * * *(d) * * *
Category II
Drug Assay limits percent 1 Type A Type B maximum (100×) Assay limits percent 1 Type B/C 2 * * * * * * * Erythromycin 85-115 4.625 g/lb (1.02%) 75-125 * * * * * * * * * * * *5. In § 558.58, remove and reserve paragraphs (e)(2), (7), and (8); remove paragraphs (e)(10) and (11); and add paragraph (f) to read as follows:
End Amendment PartStart Amendment PartAmprolium and ethopabate.* * * * *(f) Amprolium and ethopabate may also be used in combination with:
(1) [Reserved]
(2) [Reserved]
(3) Chlortetracycline as in § 558.128.
(4) Lincomycin as in § 558.325.
(5) Virginiamycin as in § 558.635.
6. Revise § 558.59 to read as follows:
End Amendment PartStart Amendment PartApramycin.(a) Specifications. Type A articles containing 75 grams apramycin (as apramycin sulfate) per pound.
(b) Sponsor. See No. 058198 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.52 of this chapter.
(d) Conditions of use in swine—
Apramycin grams/ton Combination in grams/ton Indications for use Limitations Sponsor (1) 150 For control of porcine colibacillosis (weanling pig scours) caused by susceptible strains of Escherichia coli Feed as the sole ration for 14 consecutive days. Withdraw 28 days before slaughter 058198 (2) [Reserved] 7. In § 558.76, redesignate paragraphs (e)(2)(iii) through (xvi) as paragraphs (e)(2)(iv) through (xvii); and add new paragraph (e)(2)(iii) to read as follows:
End Amendment PartStart Amendment PartBacitracin methylenedisalicylate.* * * * *(e) * * *
(2) * * *
(iii) Chlortetracycline as in § 558.128.
* * * * *8. Revise § 558.128 to read as follows:
End Amendment PartStart Amendment PartChlortetracycline.(a) Specifications. Type A medicated articles containing either chlortetracycline calcium complex equivalent to chlortetracycline hydrochloride, or for products intended for use in milk replacer, chlortetracycline hydrochloride.
(b) Approvals. See sponsors in § 510.600(c) of this chapter for use as in paragraph (e) of this section.
(1) Nos. 054771: 50, 65, or 100 grams per pound (g/lb) Type A medicated article.
(2) No. 066104: 10, 20, 30, 50, 70, or 100 g/lb of Type A medicated article.
(3) No. 069254: 50, 90, or 100 g/lb of Type A medicated article.
(c) Related tolerances. See § 556.150 of this chapter.
(d) Special considerations—(1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian. See § 558.6 for additional requirements.
(2) The expiration date of VFDs for chlortetracycline medicated feeds must not exceed 6 months from the date of issuance. VFDs for chlortetracycline shall not be refilled.
(3) In milk replacers or starter feed; include on labeling the warning: “A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.”
(4) Manufacture for use in free-choice feeds as in paragraph (e)(4)(iii) of this section must conform to § 510.455 of this chapter.
(5) When manufactured for use as in paragraph (e)(5)(iii) of this section, include on labeling the warning: “Psittacosis, avian chlamydiosis, or ornithosis is a reportable communicable disease, transmissible between wild and domestic birds, other animals, and man. Contact appropriate public health and regulatory officials.”
(e) Conditions of use—(1) Chickens. It is used as follows:
Chlortetracycline amount Combination in grams/ton Indications for use Limitations Sponsor (i) 100 to 200 g/ton Chickens: For control of infectious synovitis caused by Mycoplasma synoviae susceptible to chlortetracycline Feed continuously for 7 to 14 days. Do not feed to chickens producing eggs for human consumption 054771 066104 069254 Start Printed Page 94996 (ii) 100 to 200 g/ton Clopidol, 113.5 Broiler and replacement chickens: As an aid in the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. mivati, and E. brunetti; and for control of infectious synovitis caused by M. synoviae susceptible to chlortetracycline Feed continuously as the sole ration from the time chicks are placed in floor pens for 7 to 14 days. Do not feed to chickens over 16 weeks of age. Do not feed to chickens producing eggs for human consumption. Chlortetracycline as provided by No. 054771; clopidol as provided by No. 016592 in § 510.600(c) of this chapter 016592 (iii) 100 to 200 g/ton Decoquinate, 27.2 Chickens: For prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. mivati, E. acervulina, E. maxima, and E. brunetti; and for control of infectious synovitis caused by M, synoviae susceptible to chlortetracycline Feed continuously for 7 to 14 days. Bentonite should not be used in decoquinate feeds. Do not feed to chickens producing eggs for human consumption Chlortetracycline and decoquinate as provided by No. 054771 in § 510.600(c) of this chapter 054771 (iv) 100 g/ton Robenidine, 30 Broiler and fryer chickens: As an aid in the prevention of coccidiosis caused by E. mivati, E. brunetti, E. tenella, E. acervulina, E. maxima, and E. necatrix; as an aid in the control of chronic respiratory disease (CRD) caused by Mycoplasma gallisepticum susceptible to chlortetracycline; and as an aid in the control of infectious synovitis caused by M. synoviae susceptible to chlortetracycline Feed continuously as sole ration. Do not use this product in feeds conta Chlortetracycline and robenidine as provided by No. 054771 in § 510.600(c) of this chapter 054771 (v) 200 to 400 g/ton Chickens: For the control of chronic respiratory disease (CRD) and air sac infection caused by M. gallisepticum and Escherichia coli susceptible to chlortetracycline Feed continuously for 7 to 14 days. Do not feed to chickens producing eggs for human consumption 054771 066104 069254 (vi) 200 g/ton Amprolium, 227 and ethopabate, 3.6 For chickens where immunity to coccidiosis is not desired: For prevention of coccidiosis; and for treatment of chronic respiratory disease (CRD) caused by M. gallisepticum susceptible to chlortetracycline Use in low calcium feed containing 0.8% dietary calcium and 1.5% sodium sulfate; feed continuously as sole ration for 7 to 14 days; do not feed to chickens producing eggs for human consumption. Chlortetracycline as provided by No. 054771; amprolium and ethopabate as provided by No. 016592 in § 510.600(c) of this chapter 054771 (vii) 200 g/ton Decoquinate, 27.2 Broilers: As an aid in the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. mivati, E. maxima, and E. brunetti; and for the treatment of chronic respiratory disease (air sac infection) and the prevention of synovitis Feed continuously as the sole ration for no more than 8 weeks. Use in low calcium feed containing 0.8% dietary calcium. Bentonite should not be used in decoquinate feeds. Do not feed to chickens producing eggs for human consumption Chlortetracycline and decoquinate as provided by No. 054771 in § 510.600(c) of this chapter 054771 (viii) 200 g/ton Robenidine 30 Broiler and fryer chickens: As an aid in the prevention of coccidiosis caused by E. mivati, E. brunetti, E. tenella, E. acervulina, E. maxima, and E. necatrix; as an aid in the control of chronic respiratory disease (CRD) caused by M. gallisepticum susceptible to chlortetracycline; and as an aid in the control of infectious synovitis caused by M. synoviae susceptible to chlortetracycline Feed continuously as sole ration. Do not use this product in feeds containing bentonite. Do not feed to chickens producing eggs for human consumption. Withdraw 5 days prior to slaughter Chlortetracycline and robenidine as provided by No. 054771 in § 510.600(c) of this chapter 054771 (ix) 500 g/ton Chickens: For the reduction of mortality due to E. coli infections susceptible to chlortetracycline 1. Feed for 5 days. To sponsor No. 054771 under NADA 048-761 and No. 069254 under ANADA 200-510: zero withdrawal time 054771 069254 2. Feed for 5 days; withdraw 24 hours prior to slaughter. Do not feed to chickens producing eggs for human consumption 054771 066104 069254 Start Printed Page 94997 (x) 500 g/ton Monensin, 90 to 110 Chickens: As an aid in the reduction of mortality due to E. coli infections susceptible to chlortetracycline; and as an aid in the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati Feed for 5 days as the sole ration. Do not feed to laying chickens. Not to be fed continuously for more than 5 days. Do not feed to chickens over 16 weeks of age. Withdraw 24 hours before slaughter. See § 558.355(d) of this chapter. Chlortetracycline as provided by No. 054771; monensin as provided by No. 058198 in § 510.600(c) of this chapter 054771 069254 (xi) 500 g/ton Robenidine, 30 Broiler and fryer chickens: As an aid in the prevention of coccidiosis caused by Eimeria mivati, E. brunetti, E. tenella, E. acervulina, E. maxima, and E. necatrix; as an aid in the reduction of mortality due to E. coli susceptible to chlortetracycline Feed continuously as sole ration for up to 5 days. Do not use this product in feeds containing bentonite. Do not feed to chickens producing eggs for human consumption. Withdraw 5 days prior to slaughter Chlortetracycline and robenidine as provided by No. 054771 in § 510.600(c) of this chapter 054771 (xii) 500 g/ton Salinomycin, 40 to 60 Broiler chickens: As an aid in the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati; and as an aid in the reduction of mortality due to E. coli susceptible to chlortetracycline For use in low calcium feeds containing 0.8% calcium. Not approved for use with pellet binders. Not to be fed continuously for more than 5 days. Do not feed to laying chickens producing eggs for human consumption. Withdraw 24 hours before slaughter. May be fatal if accidentally fed to adult turkeys or horses. Chlortetracycline as provided by Nos. 054771 or 069254; salinomycin as provided by Nos. 054771 or 016592 in § 510.600(c) of this chapter 016592 054771 069254 (2) Turkeys. It is used as follows:
Chlortetracycline amount Combination in grams/ton Indications for use Limitations Sponsor (i) 200 g/ton Turkeys: For control of infectious synovitis caused by M. synoviae susceptible to chlortetracycline Feed continuously for 7 to 14 days. Do not feed to turkeys producing eggs for human consumption 054771 066104 069254 (ii) 400 g/ton 1. Turkeys: For control of hexamitiasis caused by Hexamita meleagridis susceptible to chlortetracycline Feed continuously for 7 to 14 days. Do not feed to turkeys producing eggs for human consumption 054771 066104 069254 2. Turkey poults not over 4 weeks of age: For reduction of mortality due to paratyphoid caused by Salmonella typhimurium susceptible to chlortetracycline 054771 066104 069254 (iii) 25 mg/lb of body weight Turkeys: For control of complicating bacterial organisms associated with bluecomb (transmissible enteritis; coronaviral enteritis) susceptible to chlortetracycline Feed continuously for 7 to 14 days. Do not feed to turkeys producing eggs for human consumption 054771 066104 069254 (3) Swine. It is used as follows:
Chlortetracycline amount Combination in grams/ton Indications for use Limitations Sponsor (i) 50 to 100 g/ton Swine: For reducing the incidence of cervical lymphadenitis (jowl abscesses) caused by Group E Streptococci susceptible to chlortetracycline 054771 066104 069254 Start Printed Page 94998 (ii) 400 g/ton Breeding swine: For the control of leptospirosis (reducing the incidence of abortion and shedding of leptospirae) caused by Leptospira pomona susceptible to chlortetracycline Feed continuously for not more than 14 days 054771 066104 069254 (iii) 10 mg/lb of body weight Swine: For treatment of bacterial enteritis caused by Escherichia coli and S. choleraesuis and bacterial pneumonia caused by Pasteurella multocida susceptible to chlortetracycline; for the control of porcine proliferative enteropathies (ileitis) caused by Lawsonia intracellularis susceptible to chlortetracycline Feed approximately 400 g/ton, varying with body weight and feed consumption to provide 10 mg/lb per day. Feed for not more than 14 days. Withdraw 5 d prior to slaughter for sponsor No. 069254 in § 510.600(c) of this chapter 054771 066104 069254 (iv) 10 mg/lb of body weight Bacitracin methylenedisalicylate, 10 to 30 Swine: For treatment of bacterial enteritis caused by E. coli and S. choleraesuis and bacterial pneumonia caused by P. multocida susceptible to chlortetracycline; for the control of porcine proliferative enteropathies (ileitis) caused by Lawsonia intracellularis susceptible to chlortetracycline; and for increased rate of weight gain and improved feed efficiency Feed approximately 400 g/ton, varying with body weight and feed consumption to provide 10 mg/lb per day. Feed for not more than 14 days 054771 (v) 10 mg/lb of body weight Bacitracin methylenedisalicylate, 10 to 30 Swine: For treatment of bacterial enteritis caused by E. coli and S. choleraesuis and bacterial pneumonia caused by P. multocida susceptible to chlortetracycline; and for increased rate of weight gain and improved feed efficiency Feed chlortetracycline at approximately 400 g/ton of feed, varying with body weight and food consumption, to provide 10 mg/lb of body weight. Feed for not more than 14 days. Withdraw 5 d prior to slaughter for sponsor No. 069254. Bacitracin methylenedisalicylate provided by No. 054771; chlortetracycline provided by Nos. 054771 and 069254 in § 510.600(c) of this chapter 069254 (vi) 500 to 4,000 to provide 10 mg/lb of body weight daily Tiamulin hydrogen fumarate, 35 For control of swine dysentery associated with Brachyspira (formerly Serpulina or Treponema) hyodysenteriae susceptible to tiamulin and for treatment of swine bacterial enteritis caused by E. coli and Salmonella choleraesuis sensitive to chlortetracycline and treatment of bacterial pneumonia caused by P. multocida sensitive to chlortetracycline Feed continuously as the sole ration for 14 days. Withdraw medicated feed 2 days before slaughter. Tiamulin as provided by Nos. 058198 or 069254in § 510.600(c) of this chapter 058198 069254 (4) Cattle. It is used as follows:
Chlortetracycline amount Combination in grams/ton Indications for use Limitations Sponsor (i) 0.5 mg/lb of body weight daily Beef cattle (over 700 lb): For control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline Withdraw 48 hours prior to slaughter. To sponsor Nos. 054771 and 069254: Zero withdrawal time 054771 066104 069254 Start Printed Page 94999 (ii) 25 to 1,100 to provide 0.5 mg/lb of body weight daily Lasalocid, 30 to 600 Pasture cattle (slaughter, stocker, feeder cattle, beef replacement heifers) over 700 pounds: For control of active infection of anaplasmosis caused by A. marginale susceptible to chlortetracycline; and for increased rate of weight gain Feed continuously on a hand-fed basis 0.5 mg chlortetracycline per lb. body weight per day and not less than 60 mg or more than 300 mg lasalocid per head daily in at least 1 pound of feed. Daily lasalocid intakes in excess of 200 mg/head/day in pasture cattle have not been shown to be more effective than 200 mg lasalocid/head/day. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter 054771 (iii) 0.5 to 2.0 mg/lb of body weight daily Beef cattle and nonlactating dairy cattle: As an aid in the control of active infection of anaplsmosis caused by A. marginale susceptible to chlortetracycline In free-choice cattle feeds such as feed blocks or salt-mineral mixes manufactured from approved Type A articles. See paragraph (d)(4) of this section 054771 (iv) 10 mg/lb of body weight daily 1. Calves, beef and nonlactating dairy cattle: For treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida organisms susceptible to chlortetracycline Feed approximately 400 g/ton, varying with body weight and feed consumption to provide 10 mg/lb per day. Treat for not more than 5 days. In feed including milk replacers withdraw 10 days prior to slaughter. To sponsor No. 069254: zero withdrawal time. See paragraph (d)(3) of this section 054771 066104 069254 2. Calves (up to 250 lb): For the treatment of bacterial enteritis caused by E. coli susceptible to chlortetracycline See paragraph (d)(3) of this section 054771 066104 069254 (v) 10 mg/lb of body weight daily Laidlomycin, 5 Cattle fed in confinement for slaughter: For treatment of bacterial enteritis caused by E. coli and bacterial pneumonia caused by P. multocida organisms susceptible to chlortetracycline; and for increased rate of weight and improved feed efficiency Feed continuously at a rate of 30 to 75 mg laidlomycin propionate potassium per head per day for not more than 5 days. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.305(d) of this chapter. Laidlomycin as provided by No. 054771 in § 510.600(c) of this chapter 054771 (vi) 10 mg/lb of body weight daily Laidlomycin, 5 to 10 Cattle fed in confinement for slaughter: For treatment of bacterial enteritis caused by E. coli and bacterial pneumonia caused by P. multocida organisms susceptible to chlortetracycline; and for improved feed efficiency Feed continuously at a rate of 30 to 75 mg laidlomycin propionate potassium per head per day for not more than 5 days. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.305(d) of this chapter. Laidlomycin as provided by No. 054771 in § 510.600(c) of this chapter 054771 (vii) 500 to 2,000 to provide 10 mg/lb of body weight daily Lasalocid, 10 to 30 Cattle fed in confinement for slaughter: For treatment of bacterial enteritis caused by E. coli and bacterial pneumonia caused by P. multocida organisms susceptible to chlortetracycline; and for improved feed efficiency Feed continuously in complete feed for not more than 5 days to provide 10 mg chlortetracycline per lb. body weight per day and not less than 100 mg or more than 360 mg lasalocid per head per day. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter 054771 Start Printed Page 95000 (viii) 500 to 1,200 to provide 10 mg/lb of body weight daily Lasalocid, 25 to 30 Cattle fed in confinement for slaughter: For treatment of bacterial enteritis caused by E. coli and bacterial pneumonia caused by P. multocida organisms susceptible to chlortetracycline; and for increased rate of weight gain and improved feed efficiency Feed continuously in complete feed for not more than 5 days to provide 10 mg chlortetracycline per lb. body weight per day and not less than 250 mg or more than 360 mg lasalocid per head per day. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter 054771 (ix) 500 to 4,000 to provide 10 mg/lb of body weight daily Lasalocid, 30 to 600 Pasture cattle (slaughter, stocker, feeder cattle, dairy and beef replacement heifers): For treatment of bacterial enteritis caused by E. coli and bacterial pneumonia caused by P. multocida organisms susceptible to chlortetracycline; and for increased rate of weight gain and improved feed efficiency Feed continuously on a hand-fed basis for not more than 5 days to provide 10 mg chlortetracycline per lb. body weight per day and not less than 60 mg or more than 300 mg lasalocid per head per day. Daily lasalocid intakes in excess of 200 mg/head/day in pasture cattle have not been shown to be more effective than 200 mg lasalocid/head/day. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter 054771 (x) 500 to 4,000 g/ton Calves, beef and nonlactating dairy cattle: For the treatment of bacterial enteritis caused by E. coli and bacterial pneumonia caused by P. multocida susceptible to chlortetracycline Feed continuously for not more than 5 days to provide 10 mg/lb body weight per day. To sponsor No. 054771 under NADA 046-699: 24-hour withdrawal period. To sponsor No. 054771 under NADA 048-761 and No. 069254 under ANADA 200-510: Zero withdrawal period 054771 069254 (xi) 500 to 4,000 Decoquinate, 12.9 to 90.8 Calves, beef and non-lactating dairy cattle: For the treatment of bacterial enteritis caused by E. coli and bacterial pneumonia caused by P. multocida susceptible to chlortetracycline; and for the prevention of coccidiosis caused by Eimeria bovis and E. zuernii Feed at a rate of 1g chlortetracycline per 100 lb body weight/day and 22.7 mg decoquinate per 100 lb of body weight/day for not more than 5 days. When it is fully consumed, resume feeding 22.7 mg decoquinate per 100 lb of body weight/day for a total of 28 days to prevent coccidiosis. Withdraw 24 hours prior to slaughter. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. Do not feed to animals producing milk for food. Decoquinate as provided by No. 054771 in § 510.600(c) of this chapter 054771 069254 (xii) 4,000 to 20,000 g/ton Calves, beef and nonlactating dairy cattle: For the treatment of bacterial enteritis caused by E. coli and bacterial pneumonia caused by P. multocida organisms susceptible to chlortetracycline As a top dress, varying with body weight and feed consumption, to provide 10 mg/lb per day. Treat for not more than 5 days. See paragraph (d)(3) of this section 054771 Start Printed Page 95001 (xiii) 4,000 to 20,000 g/ton Decoquinate, 90.8 to 535.7 Calves, beef and non-lactating dairy cattle: For the treatment of bacterial enteritis caused by E. coli and bacterial pneumonia caused by P. multocida susceptible to chlortetracycline; and for the prevention of coccidiosis caused by E. bovis and E. zuernii Administer as a top dress supplement or mix into the daily ration to provide 22.7 mg decoquinate per 100 lb of body weight per day and 1 g chlortetracycline per 100 lb body weight/day for not more than 5 days. When it is fully consumed, resume feeding 22.7 mg decoquinate per 100 lb of body weight/day for a total of 28 days to prevent coccidiosis. Withdraw 24 hours prior to slaughter. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. Do not feed to animals producing milk for food. Decoquinate as provided by No. 054771 in § 510.600(c) of this chapter 054771 (xiv) 70 mg/head/day Growing cattle (over 400 lb): For reduction of incidence of liver abscesses See paragraph (d)(3) of this section 054771 066104 069254 (xv) 350 mg/head/day 1. Beef cattle: For control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetracycline Withdraw 48 h prior to slaughter. To sponsor No. 054771 under NADA 046-699: 48-hour withdrawal time. To sponsor No. 054771 under NADA 048-761 and No. 069254 under ANADA 200-510: zero withdrawal period 054771 066104 069254 2. Beef cattle (under 700 lb): For control of active infection of anaplasmosis caused by A. marginale susceptible to chlortetracycline Withdraw 48 h prior to slaughter. To sponsor No. 054771 under NADA 046-699: 48-hour withdrawal time. To sponsor No. 054771 under NADA 048-761 and No. 069254 under ANADA 200-510: zero withdrawal time 054771 066104 069254 (xvi) 350 mg/head/day Laidlomycin, 5 Cattle fed in confinement for slaughter: For control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetracycline; and for increased rate of weight and improved feed efficiency Feed continuously at a rate of 30 to 75 mg laidlomycin propionate potassium per head per day. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.305(d) of this chapter. Laidlomycin as provided by No. 054771 in § 510.600(c) of this chapter 054771 (xvii) 350 mg/head/day Laidlomycin, 5 to 10 Cattle fed in confinement for slaughter: For control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetracycline; and for improved feed efficiency Feed continuously at a rate of 30 to 75 mg laidlomycin propionate potassium per head per day. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.305(d) of this chapter. Laidlomycin as provided by No. 054771 in § 510.600(c) of this chapter 054771 (xviii) 25 to 42.2 g/ton to provide 350 mg/head/day Lasalocid, 25 to 30 Cattle under 700 pounds fed in confinement for slaughter: For control of active infection of anaplasmosis caused by A. marginale susceptible to chlortetracycline; and for increased rate of weight gain and improved feed efficiency Feed continuously in complete feed at a rate of 350 mg chlortetracycline and not less than 250 mg nor more than 360 mg lasalocid per head daily. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter 054771 Start Printed Page 95002 (xix) 25 to 42.2 g/ton to provide 350 mg/head/day Lasalocid, 25 to 30 Cattle fed in confinement for slaughter: For control of bacterial pneumonia associated with shipping fever complex caused by P. multocida organisms susceptible to chlortetracycline; and for increased rate of weight gain and improved feed efficiency Feed continuously in complete feed at a rate of 350 mg chlortetracycline and not less than 250 mg nor more than 360 mg lasalocid per head daily. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter 054771 (xx) 25 to 100 g/ton to provide 350 mg/head/day Lasalocid, 10 to 30 Cattle under 700 pounds fed in confinement for slaughter: For control of active infection of anaplasmosis caused by A. marginale susceptible to chlortetracycline; and for improved feed efficiency Feed continuously in complete feed at a rate of 350 mg chlortetracycline and not less than 100 mg nor more than 360 mg lasalocid per head daily. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter 054771 (xxi) 25 to 100 g/ton to provide 350 mg/head/day Lasalocid, 10 to 30 Cattle fed in confinement for slaughter: For control of bacterial pneumonia associated with shipping fever complex caused by P. multocida organisms susceptible to chlortetracycline; and for improved feed efficiency Feed continuously in complete feed at a rate of 350 mg chlortetracycline and not less than 100 mg nor more than 360 mg lasalocid per head daily. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter 054771 (xxii) 25 to 700 to provide 350 mg/head/day Lasalocid, 30 to 600 Pasture cattle (slaughter, stocker, feeder cattle, dairy and beef replacement heifers): For control of bacterial pneumonia associated with shipping fever complex caused by P. multocida organisms susceptible to chlortetracycline; and for increased rate of weight gain Feed continuously on a hand-fed basis at a rate of 350 mg chlortetracycline and not less than 60 mg nor more than 300 mg lasalocid per head per day in at least 1 pound of feed. Daily lasalocid intakes in excess of 200 mg/head/day in pasture cattle have not been shown to be more effective than 200 mg lasalocid/head/day. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter 054771 Start Printed Page 95003 (xxiii) 25 to 700 to provide 350 mg/head/day Lasalocid, 30 to 600 Pasture cattle (slaughter, stocker, feeder cattle, beef replacement heifers) under 700 pounds: For control of active infection of anaplasmosis caused by A. marginale susceptible to chlortetracycline; and for increased rate of weight gain Feed continuously on a hand-fed basis at a rate of 350 mg chlortetracycline and not less than 60 mg nor more than 300 mg lasalocid per head per day in at least 1 pound of feed. Daily lasalocid intakes in excess of 200 mg/head/day in pasture cattle have not been shown to be more effective than 200 mg lasalocid/head/day. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter 054771 (xxiv) 25 to 2,800 to provide 350 mg/head/day Lasalocid, 30 to 181.8 Beef cattle weighing up to 800 pounds: For control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetracycline; and for the control of coccidiosis caused by E. bovis and E. zuernii Hand feed continuously at a rate of 350 mg chlortetracycline and 1 mg lasalocid per 2.2 lb. body weight daily to cattle with a maximum of 360 mg of lasalocid per head per day. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter 054771 (xxv) 500 to 4,000 to provide 350 mg/head/day Lasalocid, 30 to 181.8 Cattle weighing up to 800 pounds: For the treatment of bacterial enteritis caused by E. coli and bacterial pneumonia caused by P. multocida susceptible to chlortetracycline; and for the control of coccidiosis caused by E. bovis and E. zuernii Hand feed continuously at a rate of 350 mg chlortetracycline and 1 mg lasalocid per 2.2 lb. body weight daily to cattle with a maximum of 360 mg of lasalocid per head per day. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter 054771 (5) Minor species. It is used as follows:
Start Printed Page 95004Chlortetracycline amount Indications for use Limitations Sponsor (i) 80 mg/head/day Breeding sheep; reducing the incidence of (vibrionic) abortion caused by Campylobacter fetus infection susceptible to chlortetracycline 054771 066104 069254 (ii) 200 to 400 g/ton Ducks: For the control and treatment of fowl cholera caused by Pasteurella multocida susceptible to chlortetracycline Feed in complete ration to provide from 8 to 28 mg/lb of body weight per day, depending upon age and severity of disease, for not more than 21 days. Do not feed to ducks producing eggs for human consumption 054771 (iii) 10 mg/g of finished feed daily Psittacine birds (cockatoos, macaws, and parrots) suspected or known to be infected with psittacosis caused by Chlamydia psittaci sensitive to chlortetracycline Feed continuously for 45 days. Each bird should consume daily an amount of medicated feed equal to one fifth of its body weight. See paragraph (d)(5) of this section 054771 (6) It is used as a free-choice, loose mineral Type C feed as follows:
(i) Specifications.
Ingredient Percent International 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 article (90 gram/lb) 3.33 1 Content of vitamin and trace mineral premixes may be varied. However, they should be comparable to those used for other free-choice feeds. Formulation modifications require FDA approval prior to marketing. Selenium must comply with 21 CFR 573.920. Ethylenediamine dihydroiodide (EDDI) should comply with FDA Compliance Policy Guides Sec. 651.100 (CPG 7125.18). (ii) Amount. 6,000 grams per ton.
(iii) Indications for use. Beef and nonlactating dairy cattle: As an aid in the control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline.
(iv) Limitations. Feed continuously on a free-choice basis at a rate of 0.5 to 2.0 mg chlortetracycline per pound of body weight per day.
(v) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
9. In § 558.140, redesignate paragraph (d) as paragraph (e) and add new paragraph (d) to read as follows:
End Amendment PartChlortetracycline and sulfamethazine.* * * * *(d) Special considerations—(1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian. See § 558.6 for additional requirements.
(2) The expiration date of VFDs for chlortetracycline and sulfamethazine medicated feeds must not exceed 6 months from the date of issuance. VFDs for chlortetracycline and sulfamethazine shall not be refilled.
* * * * *Start Amendment Part[Removed]10. Remove § 558.145.
End Amendment Part Start Amendment Part11. In § 558.175, in paragraph (b), remove “ Approvals” and in its place add “Sponsor”; add paragraph (c); remove and reserve paragraphs (d)(5) and (6); and add paragraph (e) to read as follows:
End Amendment PartStart Amendment PartClopidol.* * * * *(c) Related tolerances. See § 556.160 of this chapter.
* * * * *(e) Clopidol may also be used in combination with:
(1) [Reserved]
(2) [Reserved]
(3) Chlortetracycline as in § 558.128.
(4) Lincomycin as in § 558.325.
12. In § 558.195, remove and reserve paragraphs (e)(1)(iv) through (vi), (e)(2)(ii), (e)(2)(iv), and (e)(2)(vii); and add paragraph (e)(4) to read as follows:
End Amendment PartStart Amendment PartDecoquinate.* * * * *(e) * * *
(4) Decoquinate may also be used in combination with:
(i) [Reserved]
(ii) [Reserved]
(iii) Chlortetracycline as in § 558.128.
(iv) Lincomycin as in § 558.325.
13. In § 558.198, remove and reserve paragraphs (d)(1)(iv) and (v); and add paragraph (d)(3) to read as follows:
End Amendment PartStart Amendment PartDiclazuril.* * * * *(d) * * *
(3) Diclazuril may also be used in combination with virginiamycin as in § 558.635.
14. In § 558.248, revise paragraph (a); redesignate paragraph (d) as paragraph (e); add new paragraph (d); and revise redesignated paragraph (e) to read as follows:
End Amendment PartStart Amendment PartErythromycin.(a) Specifications. Type A medicated articles containing 92.5 grams per pound erythromycin (as the thiocyanate salt).
* * * * *(d) Special considerations.—(1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian. See § 558.6 for additional requirements.
(2) The expiration date of VFDs for erythromycin medicated feeds must not exceed 6 months from the date of issuance. VFDs for erythromycin shall not be refilled.
(e) Conditions of use—(1) Chickens—
Start Printed Page 95005Erythromycin in grams/ton Combination in grams/ton Indications for use Limitations Sponsor (i) 92.5 Chickens: As an aid in the prevention of chronic respiratory disease during periods of stress Feed for 2 days before stress and 3 to 6 days after stress. Withdraw 24 hours before slaughter 061623 (ii) 92.5 Chickens: As an aid in the prevention of infectious coryza Feed for 7 to 14 days. Withdraw 24 hours before slaughter 061623 (iii) 185 Chickens: As an aid in the prevention and reduction of lesions and in lowering severity of chronic respiratory disease (CRD) Feed for 5 to 8 days. Withdraw 48 hours before slaughter. Do not use in birds producing eggs for food 061623 (2) Turkeys—
Erythromycin thiocyanate in grams/ton Combination in grams/ton Indications for use Limitations Sponsor (i) 92.5 Turkeys: As an aid in the prevention of chronic respiratory disease during periods of stress Feed for 2 days before stress and 3 to 6 days after stress 061623 (ii) 185 Turkeys: As an aid in the prevention and reduction of lesions and in lowering severity of chronic respiratory disease (CRD) Feed for 5 to 8 days. Do not use in birds producing eggs for food 061623 15. In § 558.258, remove and reserve paragraphs (e)(2)(ii) through (v); and add paragraph (e)(6) to read as follows:
End Amendment PartStart Amendment PartFenbendazole.* * * * *(e) * * *
(6) Fenbendazole may also be used in combination with:
(i) [Reserved]
(ii) Lincomycin as in § 558.325.
16. In § 558.265, remove and reserve paragraphs (d)(1)(iii), (d)(1)(iv), and (d)(1)(vii); and add paragraph (d)(4) to read as follows:
End Amendment PartStart Amendment PartHalofuginone.* * * * *(d) * * *
(4) Halofuginone may also be used in combination with:
(i) [Reserved]
(ii) Lincomycin as in § 558.325.
(iii) Virginiamycin as in § 558.635.
17. Revise § 558.274 to read as follows:
End Amendment PartStart Amendment PartHygromycin B.(a) Specifications. Type A medicated articles containing 2.4 or 8 grams hygromycin B per pound (g/lb).
(b) Sponsor. See No. 058198 in § 510.600(c) of this chapter for as follows:
(c) Related tolerances. See § 556.330 of this chapter.
(d) Special considerations—(1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian. See § 558.6 for additional requirements.
(2) The expiration date of VFDs for hygromycin B medicated feeds must not exceed 6 months from the date of issuance. VFDs for hygromycin B shall not be refilled.
(e) Conditions of use. It is used in feed as follows:
(1) Chickens—
Hygromycin B grams/ton Combination in grams/ton Indications for use Limitations Sponsor (i) 8 to 12 Chickens: For control of infections of large roundworms (Ascaris galli), cecal worms (Heterakis gallinae), and capillary worms (Capillaria obsignata) Use in complete feed. Withdraw 3 days before slaughter 058198 (ii) [Reserved] (2) Swine—
Hygromycin B grams/ton Combination in grams/ton Indications for use Limitations Sponsor (i) 12 Swine: For control of infections of large roundworms (A. suis), nodular worms (O. dentatum), and whipworms (Trichuris suis) In market hogs, use in complete feed for 8 weeks during the growing period. Withdraw 15 days before slaughter 058198 (ii) [Reserved] 18. In § 558.300, remove and reserve paragraphs (e)(4) through (7); and add paragraph (f) to read as follows:
End Amendment PartStart Amendment PartIvermectin.* * * * *(f) Ivermectin may also be used in combination with:
(1) [Reserved]
(2) Lincomycin as in § 558.325.
19. In § 558.305, remove paragraphs (e)(2), (e)(3), (e)(5), and (e)(6); redesignate paragraph (e)(4) as new paragraph (e)(2); and add paragraph (f) to read as follows:
End Amendment PartStart Amendment PartLaidlomycin.* * * * *(f) Laidlomycin may also be used in combination with chlortetracycline as in § 558.128.
20. In § 558.311, in paragraph (e)(1)(i), in the row entry for “Bambermycins 1 to 2”, in the “Lasalocid sodium in grams per ton” column, add “(ii) 68 (0.0075 pct) to 113 (0.0125 pct).”; in paragraphs (e)(1)(vi) and (vii), remove the row entries for “Oxytetracycline 7.5”; in paragraph (e)(1)(xv), remove the row entry for “Virginiamycin 10 to 20”; remove and reserve paragraphs (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:
End Amendment PartStart Amendment PartLasalocid.* * * * *(e) * * *
(5) * * *
(i) Chlortetracycline as in § 558.128.
* * * * *(iii) Virginiamycin as in § 558.635.
21. Revise § 558.325 to read as follows:
End Amendment PartStart Printed Page 95006Start Amendment PartLincomycin.(a) Specifications. Type A medicated articles containing 20 or 50 grams of lincomycin (as lincomycin hydrochloride) per pound.
(b) Sponsors. See No. 054771 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.360 of this chapter.
(d) Special considerations—(1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian. See § 558.6 for additional requirements.
(2) The expiration date of VFDs for chlortetracycline and sulfamethazine medicated feeds must not exceed 6 months from the date of issuance. VFDs for chlortetracycline and sulfamethazine shall not be refilled.
(3) Labeling of Type A medicated articles and Type B and Type C medicated feeds containing lincomycin shall bear the following:
(i) “CAUTION: Do not allow rabbits, hamsters, guinea pigs, horses, or ruminants access to feeds containing lincomycin. Ingestion by these species may result in severe gastrointestinal effects.”
(4) Labeling of medicated feeds containing lincomycin intended for use in swine shall bear the following:
(i) “CAUTION: Occasionally, swine fed lincomycin may within the first 2 days after the onset of treatment develop diarrhea and/or swelling of the anus. On rare occasions, some pigs may show reddening of the skin and irritable behavior. These conditions have been self-correcting within 5 to 8 days without discontinuing the lincomycin treatment.”
(ii) “CAUTION: The effects of lincomycin on swine reproductive performance, pregnancy, and lactation have not been determined.”
(e) Conditions of use—(1) Chickens—
Lincomycin grams/ton Combination in grams/ton Indications for use Limitations Sponsors (i) 2 Broilers: For the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to lincomycin Feed as the sole ration. Not for use in layers, breeders, or turkeys 054771 (ii) [Reserved] (2) Swine—
Lincomycin grams/ton Combination in grams/ton Indications for use Limitations Sponsors (i) 40 For control of swine dysentery and the control of porcine proliferative enteropathies (ileitis) caused by Lawsonia intracellularis Feed as sole ration. For use in swine on premises with a history of swine dysentery but where symptoms have not yet occurred, or following use of lincomycin at 100 grams (g)/ton for the treatment of swine dysentery and the control of porcine proliferative enteropathies (ileitis) 054771 (ii) 40 Fenbendazole, 10 to 80 For control of swine dysentery in animals on premises with a history of swine dysentery, but where symptoms have not yet occurred; and for the removal of: Adult stage lungworms (Metastrongylus apri and M. pudendotectus); adult and larvae (L3, 4 stages—liver, lung, intestinal forms) large roundworms (Ascaris suum); adult stage nodular worms (Oesophagostomum dentatum, O. quadrispinulatum); adult stage small stomach worms (Hyostrongylus rubidus); adult and larvae (L2, 3, 4 stages—intestinal mucosal forms) whipworms (Trichuris suis); adult and larvae kidney worms (Stephanurus dentatus) Feed as sole ration to provide a total dose of 9 mg fenbendazole/kg of body weight within 3 to 12 days. Do not feed to swine that weigh more than 250 pounds. Lincomycin as provided by No. 054771; fenbendazole as provided by No. 000061 in § 510.600(c) of this chapter 000061 Start Printed Page 95007 (iii) 40 Ivermectin, 1.8 Weaned, growing and finishing swine: For control of swine dysentery on premises with a history of swine dysentery, but where symptoms have not yet occurred; and for treatment and control of gastrointestinal roundworms (Ascaris suum, adults and fourth-stage larvae; Ascarops strongylina, adults; Hyostrongylus rubidus, adults and fourth-stage larvae; Oesophagostomum spp., adults and fourth-stage larvae); kidney worms (Stephanurus dentatus, adults and fourth-stage larvae); lungworms (Metastrongylus spp., adults); lice (Haematopinus suis); and mange mites (Sarcoptes scabiei var. suis) Feed as the only feed for 7 consecutive days to provide 0.1 mg ivermectin/kg of body weight per day. A separate feed containing 40 g/ton lincomycin may be continued to complete the lincomycin treatment. Not to be fed to swine that weigh more than 250 lbs. Withdraw 5 days before slaughter. Lincomycin as provided by No. 054771; ivermectin as provided by No. 050604 in § 510.600(c) of this chapter 050604 (iv) 40 Pyrantel, 96 For control of swine dysentery on premises with a history of swine dysentery, but where symptoms have not yet occurred; as an aid in the prevention of migration and establishment of large roundworm (Ascaris suum) infections; and as an aid in the prevention of establishment of nodular worm (Oesophagostomum spp.) infections Feed as the sole ration. Not to be fed to swine that weigh more than 250 pounds. Withdraw 6 days prior to slaughter. Lincomycin as provided by No. 054771; pyrantel as provided by No. 066104 in § 510.600(c) of this chapter 066104 (v) 40 Pyrantel, 96 For the treatment and/or control of swine dysentery; for removal and control of large roundworm (Ascaris suum) infections Feed for 3 days as the sole ration. Not to be fed to swine that weigh more than 250 pounds. Withdraw 24 hours prior to slaughter. Lincomycin as provided by No. 054771; pyrantel as provided by No. 066104 in § 510.600(c) of this chapter 066104 (vi) 40 or 100 Pyrantel, 96 For the treatment and/or control of swine dysentery; as an aid in the prevention of migration and establishment of large roundworm (Ascaris suum) infections; and as an aid in the prevention of establishment of nodular worm (Oesophagostomum spp.) infections For treatment of swine dysentery, feed 100 grams of lincomycin and 96 grams of pyrantel tartrate per ton of complete feed for 3 weeks or until clinical signs of the disease disappear, following with 40 grams of lincomycin and 96 grams of pyrantel tartrate per ton of complete feed as the sole ration. Not to be fed to swine that weigh more than 250 pounds. Withdraw 6 days prior to slaughter. Lincomycin as provided by No. 054771; pyrantel as provided by No. 066104 in § 510.600(c) of this chapter 066104 (vii) 100 For treatment of swine dysentery and the control of porcine proliferative enteropathies (ileitis) caused by Lawsonia intracellularis Feed as the sole ration for 3 weeks or until clinical signs of the disease disappear 054771 (viii) 100 Fenbendazole, 10 to 80 For the treatment of swine dysentery; and for the removal of: Adult stage lungworms (Metastrongylus apri and M. pudendotectus); adult and larvae (L3, 4 stages—liver, lung, intestinal forms) large roundworms (Ascaris suum); adult stage nodular worms (Oesophagostomum dentatum, O. quadrispinulatum); adult stage small stomach worms (Hyostrongylus rubidus); adult and larvae (L2, 3, 4 stages—intestinal mucosal forms) whipworms (Trichuris suis); adult and larvae kidney worms (Stephanurus dentatus) Feed as sole ration to provide a total dose of 9 mg fenbendazole/kg of body weight within 3 to 12 days. Do not feed to swine that weigh more than 250 pounds. Do not use within 6 days of slaughter. Lincomycin as provided by No. 054771; fenbendazole as provided by No. 000061 in § 510.600(c) of this chapter 000061 Start Printed Page 95008 (ix) 100 Ivermectin, 1.8 Weaned, growing and finishing swine: For the treatment of swine dysentery; and for treatment and control of gastrointestinal roundworms (Ascaris suum, adults and fourth-stage larvae; Ascarops strongylina, adults; Hyostrongylus rubidus, adults and fourth-stage larvae; Oesophagostomum spp., adults and fourth-stage larvae); kidneyworms (Stephanurus dentatus, adults and fourth-stage larvae); lungworms (Metastrongylus spp., adults); lice (Haematopinus suis); and mange mites (Sarcoptes scabiei var. suis) Feed as the only feed for 7 consecutive days to provide 0.1 mg ivermectin/kg of body weight per day. A separate feed containing 100 g/ton lincomycin may be continued to complete the lincomycin treatment. Not to be fed to swine that weigh more than 250 lbs. Withdraw 6 days before slaughter. Lincomycin as provided by No. 054771; ivermectin as provided by No. 050604 in § 510.600(c) of this chapter 050604 (x) 100 Pyrantel, 96 For the treatment of swine dysentery; as an aid in the prevention of migration and establishment of large roundworm (Ascaris suum) infections; and as an aid in the prevention of establishment of nodular worm (Oesophagostomum spp.) infections Feed as the sole ration for 3 weeks or until clinical signs of the disease disappear. Not to be fed to swine that weigh more than 250 pounds. Withdraw 6 days prior to slaughter. Lincomycin as provided by No. 054771; pyrantel as provided by No. 066104 in § 510.600(c) of this chapter 066104 (xi) 100 Pyrantel, 96 For the treatment and/or control of swine dysentery; for removal and control of large roundworm (Ascaris suum) infections Feed for 3 days as the sole ration. Not to be fed to swine that weigh more than 250 pounds. Withdraw 24 hours prior to slaughter. Lincomycin as provided by No. 054771; pyrantel as provided by No. 066104 in § 510.600(c) of this chapter 066104 (xii) 100 Pyrantel, 800 For the treatment and/or control of swine dysentery; for removal and control of large roundworm (Ascaris suum) and nodular worm (Oesophagostomum spp.) infections Feed as a single therapeutic treatment. Not to be fed to swine that weigh more than 250 pounds. Withdraw 24 hours prior to slaughter. Lincomycin as provided by No. 054771; pyrantel as provided by No. 066104 in § 510.600(c) of this chapter 066104 (xiii) 200 For reduction in the severity of swine mycoplasmal pneumonia caused by Mycoplasma hyopneumoniae Feed as sole ration for 21 days 054771 (xiv) 200 Fenbendazole, 10 to 80 For reduction in the severity of swine mycoplasmal pneumonia caused by Mycoplasma hyopneumoniae; and for the removal of: Adult stage lungworms (Metastrongylus apri and M. pudendotectus); adult and larvae (L3, 4 stages—liver, lung, intestinal forms) large roundworms (Ascaris suum); adult stage nodular worms (Oesophagostomum dentatum, O. quadrispinulatum); adult stage small stomach worms (Hyostrongylus rubidus); adult and larvae (L2, 3, 4 stages—intestinal mucosal forms) whipworms (Trichuris suis); adult and larvae kidney worms (Stephanurus dentatus) Feed as sole ration to provide a total dose of 9 mg fenbendazole/kg of body weight within 3 to 12 days. Do not feed to swine that weigh more than 250 pounds. Do not use within 6 days of slaughter. Lincomycin as provided by No. 054771; fenbendazole as provided by No. 000061 in § 510.600(c) of this chapter 000061 Start Printed Page 95009 (xv) 200 Ivermectin, 1.8 For reduction in the severity of swine mycoplasmal pneumonia caused by Mycoplasma hyopneumoniae; and for treatment and control of gastrointestinal roundworms (Ascaris suum, adults and fourth-stage larvae; Ascarops strongylina, adults; Hyostrongylus rubidus, adults and fourth-stage larvae; Oesophagostomum spp., adults and fourth-stage larvae); kidneyworms (Stephanurus dentatus, adults and fourth-stage larvae); lungworms (Metastrongylus spp., adults); lice (Haematopinus suis); and mange mites (Sarcoptes scabiei var. suis) Feed as the only feed for 7 consecutive days to provide 0.1 mg ivermectin/kg of body weight per day. A separate feed containing 200 g/ton lincomycin may be continued for an additional 14 days to complete the lincomycin treatment. Not to be fed to swine that weigh more than 250 lbs. Withdraw 6 days before slaughter. Lincomycin as provided by No. 054771; ivermectin as provided by No. 050604 in § 510.600(c) of this chapter 050604 (xvi) 200 Pyrantel, 96 For reduction in the severity of swine mycoplasmal pneumonia caused by Mycoplasma hyopneumoniae; and as an aid in the prevention of migration and establishment of large roundworm (Ascaris suum) infections; aid in the prevention of establishment of nodular worm (Oesophagostomum spp.) infections Feed as the sole ration for 21 days. Not for use in swine that weigh more than 250 pounds. Withdraw 6 days before slaughter. Lincomycin as provided by No. 054771; pyrantel as provided by No. 066104 in § 510.600(c) of this chapter 054771 22. In § 558.342, remove and reserve paragraphs (e)(1)(iii), (e)(1)(iv), (e)(1)(viii), (e)(1)(ix), and (e)(1)(xi); and revise paragraph (e)(2) to read as follows:
End Amendment PartStart Amendment PartMelengestrol.* * * * *(e) * * *
(2) Melengestrol may also be used in combination with:
(i) Ractopamine as in § 558.500.
(ii) Tylosin as in § 558.625.
(iii) Zilpaterol as in § 558.665.
23. In § 558.355, revise paragraphs (a) and (b); remove and reserve paragraphs (f)(1)(viii), (f)(1)(ix), (f)(1)(xiii), (f)(1)(xiv), (f)(1)(xxi), (f)(1)(xxii), (f)(1)(xxxi), (f)(2)(iv), (f)(3)(ii), and (f)(3)(xii); and revise paragraph (f)(8) to read as follows:
End Amendment PartStart Amendment PartMonensin.(a) Specifications. Type A medicated articles containing 45, 60, 90.7, or 110 grams monensin, USP, per pound.
(b) Approvals. See sponsor numbers in § 510.600(c) of this chapter for conditions of use as in paragraph (f) of this section:
(1) No. 058198 for use as in paragraph (f) of this section.
(2) No. 054771 for use as in paragraphs (f)(1)(xxiv) and (xxv) of this section.
(3) No. 058198 for use as in paragraphs (f)(1)(i), (iii), (iv), and (v) of this section.
* * * * *(f) * * *
(8) Monensin may also be used in combination with:
(i) Chlortetracycline as in § 558.128.
(ii) Decoquinate as in § 558.195.
(iii) Lincomycin as in § 558.325.
(iv) Melengestrol acetate as in § 558.342.
(v) Oxytetracycline as in § 558.128.
(vi) Ractopamine alone or in combination as in § 558.500.
(vii) Tilmicosin as in § 558.618.
(viii) Tylosin as in § 558.625.
(ix) Virginiamycin as in § 558.635.
(x) Zilpaterol alone or in combination as in § 558.665.
24. In § 558.364, redesignate paragraph (d) as paragraph (e) and revise paragraphs (a) through (d) to read as follows:
End Amendment PartStart Amendment PartNeomycin sulfate.(a) Specifications. Type A medicated article containing 325 grams neomycin sulfate per pound.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.430 of this chapter.
(d) Special considerations—(1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian. See § 558.6 for additional requirements.
(2) The expiration date of VFDs for neomycin medicated feeds must not exceed 6 months from the date of issuance. VFDs for neomycin shall not be refilled.
* * * * *25. In § 558.366, in the table in paragraph (d), remove the row entries under “Nicarbazin in grams per ton” “27 to 45” for “Narasin 27 to 45 and Lincomycin 2 to 4”; and under “Nicarbazin in grams per ton” “113.5 (0.0125 pct)” for “Lincomycin 2 (0.00044 pct)”; and add paragraph (e) to read as follows:
End Amendment PartNicarbazin.* * * * *(e) * * *
(6) Nicarbazin may also be used in combination with:
(i) [Reserved]
(ii) Lincomycin as in § 558.325.
Start Amendment Part[Removed]26. Remove § 556.435.
End Amendment Part Start Amendment Part27. Revise § 558.450 to read as follows:
End Amendment PartStart Amendment PartOxytetracycline.(a) Specifications. Each pound of Type A medicated article contains:
(1) Oxytetracycline (from oxytetracycline quaternary salt) equivalent to 50 or 100 grams oxytetracycline hydrochloride; or oxytetracycline (from oxytetracycline dihydrate base) equivalent to 10, 30, 50, 100, or 200 grams oxytetracycline hydrochloride.
(2) Oxytetracycline (from oxytetracycline dihydrate base) equivalent to 50, 100, or 200 grams oxytetracycline hydrochloride; or 100 grams oxytetracycline hydrochloride.
(b) Sponsors. See sponsors in § 510.600(c) of this chapter as follows:Start Printed 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 § 556.500 of this chapter.
(d) Special considerations—(1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian. See § 558.6 for additional requirements.
(2) The expiration date of VFDs for oxytetracycline medicated feeds must not exceed 6 months from the date of issuance. VFDs for oxytetracycline shall not be refilled.
(3) In accordance with § 558.5, labeling shall bear the statement: “For use in dry animal feed only. Not for use in liquid feed supplements.”
(e) Conditions of use—(1) Chickens—
Oxytetracycline amount Combination in grams/ton Indications for use Limitations Sponsor (i) 100 to 200 g/ton Chickens: For control of infectious synovitis caused by Mycoplasma synoviae and control of fowl cholera caused by Pasteurella multocida susceptible to oxytetracycline Feed continuously for 7 to 14 days. Do not feed to chickens producing eggs for human consumption. Do not use in feed containing less than 0.55% dietary calcium. Use in such low calcium feeds may result in violative residues. Zero-day withdrawal period 066104 069254 (ii) 200 g/ton Monensin, 90 to 110 Broiler chickens: As an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima; and for the control of complicated chronic respiratory disease (CRD or air sac infection) caused by Mycoplasma gallisepticum and Escherichia coli Feed continuously as the sole ration. Do not feed to laying chickens. Do not feed to chickens over 16 weeks of age. Do not use in feed containing less than 0.55% dietary calcium. Use in such low calcium feeds may result in violative residues. Withdraw 72 hours before slaughter. See § 558.355(d) of this chapter Oxytetracycline as provided by No. 066104; monensin as provided by No. 058198 in § 510.600(c) of this chapter 066104 (iii) 400 g/ton Chickens: For control of chronic respiratory disease (CRD) and air sac infection caused by Mycoplasma gallisepticum and Escherichia coli susceptible to oxytetracycline Feed continuously for 7 to 14 days. Do not feed to chickens producing eggs for human consumption. Do not use in feed containing less than 0.55% dietary calcium. Use in such low calcium feeds may result in violative residues. Zero-day withdrawal period 066104 069254 (iv) 400 g/ton Robenidine, 30 Broiler chickens: As an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima; and for the control of chronic respiratory disease (CRD) and air sac infection caused by Mycoplasma gallisepticum and Escherichia coli susceptible to oxytetracycline Feed continuously for 7 to 14 days. Do not feed to chickens producing eggs for human consumption. Do not use in feed containing less than 0.55% dietary calcium. Use in such low calcium feeds may result in violative residues. Withdraw 5 days before slaughter. Oxytetracycline as provided by No. 066104; robenidine as provided by No. 054771 in § 510.600(c) of this chapter 066104 (v) 500 g/ton Chickens: For reduction of mortality due to air sacculitis (air sac infection) caused by E. coli susceptible to oxytetracycline Feed continuously for 5 days. Do not feed to chickens producing eggs for human consumption. Do not use in feed containing less than 0.55% dietary calcium. Use in such low calcium feeds may result in violative residues. Withdraw 24 hours before slaughter 066104 069254 (vi) 500 g/ton Monensin, 90 to 100 Broiler chickens: As an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima; and as an aid in the reduction of mortality due to air-sacculitis (air sac infection) caused by Escherichia coli sensitive to oxytetracycline Feed for 5 days as the sole ration. Treat at first clinical signs of the disease. Do not feed to laying chickens. Do not feed to chickens over 16 weeks of age. Do not use in feed containing less than 0.55% dietary calcium. Use in such low calcium feeds may result in violative residues. Withdraw 72 hours before slaughter. See § 558.355(d) of this chapter. Oxytetracycline as provided by No. 066104; monensin as provided by No. 058198 in § 510.600(c) of this chapter 066104 Start Printed Page 95011 (vii) 500 g/ton Salinomycin, 40 to 60 Chickens: For the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima; and as an aid in the reduction of mortality due to air-sacculitis (air sac infection) caused by E. coli sensitive to oxytetracycline Feed for 5 days as the sole ration. Treat at first clinical signs of the disease. Do not feed to laying chickens. Do not use in feed containing less than 0.55% dietary calcium. Use in such low calcium feeds may result in violative residues. Withdraw 24 hours before slaughter. Oxytetracycline as provided by No. 066104; salinomycin as provided by No. 016592 in § 510.600(c) of this chapter 066104 016592 (2) Turkeys—
Oxytetracycline amount Indications for use Limitations Sponsor (i) 100 g/ton Turkeys: For control of hexamitiasis caused by Hexamita meleagridis susceptible to oxytetracycline Feed continuously for 7 to 14 days. Do not feed to turkeys producing eggs for human consumption. Zero-day withdrawal period 066104 069254 (ii) 200 g/ton Turkeys: For control of infectious synovitis caused by M. synoviae susceptible to oxytetracycline Feed continuously for 7 to 14 days. Do not feed to turkeys producing eggs for human consumption. For No. 066104, withdraw 5 days before slaughter. For No. 069254, zero-day withdrawal period 066104 069254 (iii) 25 mg/lb of body weight daily Turkeys: For control of complicating bacterial organisms associated with bluecomb (transmissible enteritis; coronaviral enteritis) susceptible to oxytetracycline Feed continuously for 7 to 14 days. Do not feed to turkeys producing eggs for human consumption. For No. 066104, withdraw 5 days before slaughter. For No. 069254, zero-day withdrawal period 066104 069254 (3) Swine—
Oxytetracycline amount Combination in grams/ton Indications for use Limitations Sponsor (i) 10 mg/lb of body weight daily 1. Swine: For treatment of bacterial enteritis caused by Escherichia coli and Salmonella choleraesuis susceptible to oxytetracycline and treatment of bacterial pneumonia caused by Pasteurella multocida susceptible to oxytetracycline Feed continuously for 7 to 14 days 066104 069254 2. Breeding swine: For control and treatment of leptospirosis (reducing the incidence of abortion and shedding of leptospirae) caused by Leptospira pomona susceptible to oxytetracycline Feed continuously for 14 days 066104 069254 (ii) 10 mg/lb of body weight daily Carbadox, 10 to 25 Swine: For treatment of bacterial enteritis caused by E. coli and Salmonella choleraesuis susceptible to oxytetracycline and treatment of bacterial pneumonia caused by Pasteurella multocida susceptible to oxytetracycline; and for increased rate of weight gain and improved feed efficiency Feed continuously as the sole ration for 7 to 14 days. Not for use in pregnant swine or swine intended for breeding purposes. Do not mix in feeds containing bentonite. Do not feed to swine within 42 days of slaughter. Oxytetracycline and carbadox as provided by No. 066104 in § 510.600(c) of this chapter 066104 (4) Cattle—Start Printed Page 95012
Oxytetracycline amount Combination in grams/ton Indications for use Limitations Sponsor (i) 10 mg/lb of body weight daily 1. Calves and beef and nonlactating dairy cattle: For treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia (shipping fever complex) caused by Pasteurella multocida susceptible to oxytetracycline Feed continuously for 7 to 14 days. For No. 069254, withdraw 5 days before slaughter. For No. 066104, zero-day withdrawal period 066104 069254 2. Calves: For treatment of bacterial enteritis caused by E. coli susceptible to oxytetracycline Feed continuously for 7 to 14 days in milk replacer or starter feed. This product is not approved for use in female dairy cattle 20 months of age or older, including dry dairy cows. Use in these cattle may cause drug residues in milk and/or in calves born to these cows. For No. 069254, withdraw 5 days before slaughter. For No. 066104, zero-day withdrawal period 066104 069254 (ii) 75 mg/head/day Growing cattle (over 400 lb): For reduction of incidence of liver abscesses Feed continuously 066104 069254 (iii) 0.5 to 2.0 g/head/day Cattle: For prevention and treatment of the early stages of shipping fever complex Feed 3 to 5 days before and after arrival in feedlots 066104 069254 (5) Minor species—
Oxytetracycline amount Indications for use Limitations Sponsor (i) 10 mg/lb of body weight daily Sheep: For treatment of bacterial enteritis caused by E. coli and bacterial pneumonia caused by P. multocida susceptible to oxytetracycline Feed continuously for 7 to 14 days; withdraw 5 days before slaughter 066104 069254 (ii) 200 mg/colony Honey bees: For control of American foulbrood caused by Paenibacillus larvae and European foulbrood caused by Streptococcus pluton susceptible to oxytetracycline Remove at least 6 weeks prior to main honey flow 066104 069254 (iii) 250 mg/kilogram of fish/day (11.35 g/100 lb of fish/day) Pacific salmon: For marking of skeletal tissue For salmon not over 30 g body weight; administer as sole ration for 4 consecutive days; fish not to be liberated for at least 7 days following the last administration of medicated feed 066104 (iv) 2.5 to 3.75 g/100 lb of fish/day 1. Salmonids: For control of ulcer disease caused by Haemophilus piscium, furunculosis caused by Aeromonas salmonicida, bacterial hemorrhagic septicemia caused by A. liquefaciens, and pseudomonas disease Administer in mixed ration for 10 days; do not liberate fish or slaughter fish for food for 21 days following the last administration of medicated feed 066104 2. Catfish: For control of bacterial hemorrhagic septicemia caused by A. liquefaciens and pseudomonas disease Administer in mixed ration for 10 days; do not liberate fish or slaughter fish for food for 21 days following the last administration of medicated feed; do not administer when water temperature is below 16.7 °C (62 °F) 066104 (v) 3.75 g/100 lb of fish/day 1. Freshwater-reared salmonids: For control of mortality due to coldwater disease associated with Flavobacterium psychrophilum Administer in mixed ration for 10 days; do not liberate fish or slaughter fish for food for 21 days following the last administration of medicated feed 066104 2. Freshwater-reared Oncorhynchus mykiss: For control of mortality due to columnaris disease associated with Flavobacterium columnare Administer in mixed ration for 10 days; do not liberate fish or slaughter fish for food for 21 days following the last administration of medicated feed 066104 (vi) 1 g/lb of medicated feed Lobsters: For control of gaffkemia caused by Aerococcus viridans Administer as sole ration for 5 consecutive days; withdraw medicated feed 30 days before harvesting lobsters 066104 28. In § 558.455, revise paragraph (d); remove and reserve paragraphs (e)(1)(i), (e)(2)(i), (e)(3)(i), (e)(4)(i), (e)(4)(ii), and (e)(4)(iv); and in paragraph (e)(4)(v), remove “increased rate of weight gain; improved feed efficiency, and” to read as follows:
End Amendment PartOxytetracycline 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 § 558.6 for additional requirements.
(2) The expiration date of VFDs for oxytetracycline and neomycin Start Printed Page 95013medicated 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.”
* * * * *Start Amendment Part[Removed]29. Remove § 558.460.
End Amendment Part Start Amendment Part30. In § 558.485, remove paragraphs (e)(1)(v) through (xii); and add paragraph (e)(3) to read as follows:
End Amendment PartStart Amendment PartPyrantel.* * * * *(e) * * *
(3) Pyrantel may also be used in combination with:
(i) Lincomycin as in § 558.325.
(ii) Tylosin as in § 558.325.
31. In § 558.500, remove and reserve paragraphs (e)(1)(ii), (iii), and (iv), (e)(2)(iv), (e)(2)(ix) and (x); remove paragraph (e)(2)(xiii); and add paragraph (e)(4) to read as follows:
End Amendment PartStart Amendment PartRactopamine.* * * * *(e) * * *
(4) Ractopamine may also be used in combination with tylosin in as in § 558.625.
32. In § 558.515, in the table in paragraph (d), remove the row entries for “Chlortetracycline 100 to 200”, “Chlortetracycline 200 to 400”, “Chlortetracycline 500”, “Lincomycin 2”, and “Oxytetracycline 400” in the “Combination in grams/ton” column; and add paragraph (e) to read as follows:
End Amendment PartStart Amendment PartRobenidine.* * * * *(e) Robenidine may also be used in combination with:
(1) Chlortetracycline as in § 558.128.
(2) Lincomycin as in § 558.325.
(3) Oxytetracycline as in § 558.450.
33. In § 558.550, remove and reserve paragraphs (d)(1)(x), (d)(1)(xi), (d)(1)(xiii), and (d)(1)(xvi); and revise paragraph (d)(4) to read as follows:
End Amendment PartStart Amendment PartSalinomycin.* * * * *(d) * * *
(5) Salinomycin may also be used in combination with:
(i) [Reserved]
(ii) [Reserved]
(iii) Chlortetracycline as in § 558.128.
(iv) Lincomycin as in § 558.325.
(v) Oxytetracycline as in § 558.450.
(vi) Virginiamycin as in § 558.635.
34. In § 558.555, remove paragraphs (d)(3) through (5); (e)(3) and (e)(4); remove and reserve paragraph (e)(2); and add paragraph (f) to read as follows:
End Amendment PartStart Amendment PartSemduramycin.* * * * *(f) Semduramycin may also be used in combination with virginiamycin as in § 558.635.
35. In § 558.575, revise the section heading; redesignate paragraphs (b), (c), and (d) as paragraphs (c), (d), and (e); revise paragraph (a); and add new paragraphs (b) and (d) to read as follows:
End Amendment PartStart Amendment PartSulfadimethoxine and ormetoprim.(a) Specifications. Type A medicated articles containing either:
(1) 25 percent sulfadimethoxine and 15 percent ormetoprim; or
(2) 25 percent sulfadimethoxine and 5 percent ormetoprim.
(b) Sponsors. See sponsors in § 510.600(c) of this chapter for use as in paragraph (d) of this section:
(1) No. 054771 for use of the product described in paragraph (a)(1) as in paragraphs (e)(1), (e)(2), (e)(3), (e)(4), and (e)(7) of this section.
(2) No. 015331 for use of the product described in paragraph (a)(2) as in paragraphs (e)(5) and (e)(6) of this section.
* * * * *(d) Special considerations.—(1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian. See § 558.6 for additional requirements.
(2) The expiration date of VFDs for sulfadimethoxine and ormetoprim medicated feeds must not exceed 6 months from the date of issuance. VFDs for sulfadimethoxine and ormetoprim shall not be refilled.
* * * * *36. Revise § 558.582 to read as follows:
End Amendment PartStart Amendment PartSulfamerazine.(a) Specifications. Type A medicated articles containing 99 percent sulfamerazine.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.660 of this chapter.
(d) Special considerations—(1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian. See § 558.6 for additional requirements.
(2) The expiration date of VFDs for sulfamerazine medicated feeds must not exceed 6 months from the date of issuance. VFDs for sulfamerazine shall not be refilled.
(e) Conditions of use. It is used in fish feed for as follows:
Sulfamerazine grams/ton Combination in grams/ton Indications for use Limitations Sponsor (1) To deliver 10 grams of sulfamerazine per 100 pounds of fish per day Rainbow trout, brook trout, and brown trout: For control of furunculosis Formulate to deliver 10 grams of sulfamerazine per 100 pounds of fish per day. Treat for not more than 14 days. Do not treat within 3 weeks of marketing or stocking in stream open to fishing 054771 (2) [Reserved] 37. Revise § 558.586 to read as follows:
End Amendment PartStart Amendment PartSulfaquinoxaline.(a) Specifications. Type A medicated articles containing 40 percent sulfaquinoxaline.
(b) Sponsor. See No. 016592 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.685 of this chapter.
(d) Special considerations—(1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian. See § 558.6 for additional requirements.
(2) The expiration date of VFDs for sulfaquinoxaline medicated feeds must not exceed 6 months from the date of issuance. VFDs for sulfaquinoxaline shall not be refilled.
(e) Conditions of use—(1) Chickens—Start Printed Page 95014
Sulfaquinoxaline in grams/ton Combination in grams/ton Indications for use Limitations Sponsor (i) 0.015 percent As an aid in preventing outbreaks of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, and E. brunetti under average conditions of exposure Feed continuously from the time birds are placed on litter and continue past the age when coccidiosis is ordinarily a hazard. If death losses exceed 0.5 percent in a 2-day period, obtain a laboratory diagnosis. If coccidiosis is the cause, use the sulfaquinoxaline levels recommended for control of outbreaks, returning to the original dosage schedule after the outbreak has subsided. Losses may result from intercurrent disease, other conditions affecting drug intake, or variant strains of coccidia species which can contribute to the virulence of coccidiosis under field conditions. Do not treat chickens within 10 days of slaughter. Do not medicate chickens producing eggs for human consumption 016592 (ii) 0.0175 percent As an aid in preventing outbreaks of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, and E. brunetti where excessive exposure to coccidia is increased due to overcrowding or other management factors Feed continuously from the time birds are placed on litter and continue past the age when coccidiosis is ordinarily a hazard. If death losses exceed 0.5 percent in a 2-day period, obtain a laboratory diagnosis. If coccidiosis is the cause, use the sulfaquinoxaline levels recommended for control of outbreaks, returning to the original dosage schedule after the outbreak has subsided. Losses may result from intercurrent disease, other conditions affecting drug intake, or variant strains of coccidia species which can contribute to the virulence of coccidiosis under field conditions. Do not treat chickens within 10 days of slaughter. Do not medicate chickens producing eggs for human consumption 016592 (iii) 0.1 to 0.05 percent As an aid in controlling outbreaks of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, and E. brunetti Feed at 0.1 percent level for first 48 to 72 hours. Skip 3 days; 0.05 percent for 2 days, skip 3 days; 0.05 percent for 2 days. If bloody droppings recur, give 0.05 percent for another 2 days. Do not treat chickens within 10 days of slaughter. Do not medicate chickens producing eggs for human consumption 016592 (iv) 0.05 or 0.1 percent As an aid in the control of acute fowl cholera caused by Pasteurella multocida susceptible to sulfaquinoxaline and fowl typhoid caused by Salmonella gallinarum susceptible to sulfaquinoxaline Feed 0.1 percent for 48 to 72 hours. Mortality should be brought under control. After medication, move birds to clean ground or to a clean house. If disease recurs, use 0.05 percent in feed again for 2 days. Do not treat chickens or turkeys within 10 days of slaughter for food. Do not medicate chickens or turkeys producing eggs for human consumption 016592 (2) Turkeys—Start Printed Page 95015
Sulfaquinoxaline in grams/ton Combination in grams/ton Indications for use Limitations Sponsor (i) 0.0175 percent As an aid in preventing outbreaks of coccidiosis caused by Eimeria meleagrimitis and E. adenoeides Feed continuously during time birds are closely confined. May be continued for a week to 10 days after flock is transferred to range to reduce danger of an outbreak following moving of the flock. Do not treat turkeys within 10 days of slaughter. Do not medicate turkeys producing eggs for human consumption 016592 (ii) 0.05 percent As an aid in controlling outbreaks of coccidiosis caused by Eimeria meleagrimitis and E. adenoeides Feed for 2 days. Follow with 3 days on regular feed and 2 more days on 0.05 percent sulfaquinoxaline feed. Again follow with 3 days on regular feed and 2 more days on 0.05 percent sulfaquinoxaline feed. Continue this schedule if necessary until all signs of the outbreaks have subsided. Do not treat turkeys within 10 days of slaughter. Do not medicate turkeys producing eggs for human consumption 016592 (iii) 0.05 or 0.1 percent As an aid in the control of acute fowl cholera caused by Pasteurella multocida susceptible to sulfaquinoxaline and fowl typhoid caused by Salmonella gallinarum susceptible to sulfaquinoxaline Feed 0.1 percent for 48 to 72 hours. Mortality should be brought under control. After medication, move birds to clean ground or to a clean house. If disease recurs, use 0.05 percent in feed again for 2 days. Do not treat chickens or turkeys within 10 days of slaughter for food. Do not medicate chickens or turkeys producing eggs for human consumption 016592 (3) Rabbits—
Sulfaquinoxaline in grams/ton Combination in grams/ton Indications for use Limitations Sponsor (i) 0.025 percent As an aid in preventing coccidiosis caused by Eimeria stiedae Treatment to be started after weaning. Feed continuously for 30 days or feed medicated feed for 2 days out of every week until marketing. Do not treat within 10 days of slaughter 016592 (ii) 0.1 percent As an aid in controlling outbreaks of coccidiosis caused by Eimeria stiedae Feed for 2 weeks. Do not treat within 10 days of slaughter 016592 38. In § 558.612, remove paragraphs (e)(1)(i) and (e)(1)(iii); redesignate paragraphs (e)(1)(ii) and (e)(1)(iv) as new paragraphs (e)(1)(i) and (ii); and add paragraph (e)(2) to read as follows:
End Amendment PartStart Amendment PartTiamulin.* * * * *(e) * * *
(2) Tiamulin may also be used in combination with chlortetracycline as in § 558.128.
39. Amend § 558.625 as follows:
End Amendment Part Start Amendment Parta. Remove paragraph (d);
End Amendment Part Start Amendment Partb. Redesignate paragraphs (c), (e), and (f) as paragraphs (d), (c) and (e); and
End Amendment Part Start Amendment Partc. Revise paragraph (b) and redesignated paragraphs (d) and (e).
End Amendment PartThe revisions read as follows:
Start Amendment PartTylosin.* * * * *(b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter.
(1) No. 016592: Type medicated article containing 100 grams per pound.
(2) No. 054771: Type medicated article containing 40 grams per pound.
(3) No. 058198: Type medicated article containing 10, 40, or 100 grams per pound.
(4) No. 066104: Type medicated article containing 20 or 40 grams per pound.
(c) Related tolerances. See § 556.360 of this chapter.
(d) Special considerations—(1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian. See § 558.6 for additional requirements.
(2) The expiration date of VFDs for oxytetracycline medicated feeds must 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 Start Printed Page 95016the tank that is visible at the top. Agitate daily as described even when not used.
(e) Conditions of use—(1) Swine—
Tylosin grams/ton Combination in grams/ton Indications for use Limitations Sponsors (i) 40 or 100 For control of swine dysentery associated with Brachyspira hyodysenteriae Feed as the sole ration 100 g of tylosin per ton of complete feed for at least 3 weeks. Follow with 40 grams per ton of complete feed until market weight 016592 054771 058198 066104 (ii) 40 or 100 Pyrantel, 96 For control of swine dysentery associated with Brachyspira hyodysenteriae; and as an aid in the prevention of migration and establishment of large roundworm (Ascaris suum) infections; aid in the prevention of establishment of nodular worm (Oesophagostomum spp.) infections Feed as the sole ration 100 g of tylosin per ton of complete feed for at least 3 weeks. Follow with 40 grams per ton of complete feed until market weight. Tylosin phosphate and pyrantel as provided by No. 066104 in § 510.600(c) of this chapter 066104 (iii) 40 or 100 For control of porcine proliferative enteropathies (ileitis) associated with Lawsonia intracellularis Feed as the sole ration 100 g of tylosin per ton of complete feed for at least 3 weeks. Follow with 40 grams per ton of complete feed until market weight 016592 054771 058198 066104 (iv) 40 or 100 Pyrantel, 96 For control of porcine proliferative enteropathies (ileitis) associated with Lawsonia intracellularis; and as an aid in the prevention of migration and establishment of large roundworm (Ascaris suum) infections; aid in the prevention of establishment of nodular worm (Oesophagostomum spp.) infections Feed as the sole ration 100 g of tylosin per ton of complete feed for at least 3 weeks. Follow with 40 grams per ton of complete feed until market weight. Tylosin phosphate and pyrantel as provided by No. 066104 in § 510.600(c) of this chapter 066104 (v) 40 or 100 Ractopamine, 4.5 to 9.0 Finishing swine: For the control of swine dysentery associated with Brachyspira hyodysenteriae; for control of porcine proliferative enteropathies (ileitis) associated with Lawsonia intracellularis; and for increased rate of weight gain, improved feed efficiency, and increased carcass leanness in finishing swine weighing not less than 150 lbs, fed a complete ration containing at least 16% crude protein for the last 45 to 90 lbs of gain prior to slaughter Feed continuously as the sole ration to finishing swine weighing not less than 150 lbs for the last 45 to 90 lbs (group average) of weight gain prior to slaughter. Include 100 g/ton of tylosin for at least 3 weeks, followed by 40 g/ton until market weight. Tylosin phosphate as provided by Nos. 058198 and 016592; ractopamine as provided by Nos. 058198 and 054771 in § 510.600(c) of this chapter 016592 054771 058198 (vi) 40 to 100 For the treatment and control of swine dysentery associated with Brachyspira hyodysenteriae immediately after medicating with tylosin in drinking water Administer as tylosin phosphate in feed continuously as the sole ration for 2 to 6 weeks, immediately after treatment with tylosin tartrate in drinking water for 3 to 10 days as in § 520.2640(d)(3) of this chapter 016592 054771 058198 066104 (vii) 40 to 100 Pyrantel, 96 For the treatment and control of swine dysentery associated with Brachyspira hyodysenteriae immediately after medicating with tylosin in drinking water; and as an aid in the prevention of migration and establishment of large roundworm (Ascaris suum) infections; aid in the prevention of establishment of nodular worm (Oesophagostomum spp.) infections Administer as tylosin phosphate in feed continuously as the sole ration for 2 to 6 weeks, immediately after treatment with tylosin tartrate in drinking water for 3 to 10 days as in § 520.2640(d)(3) of this chapter. Tylosin phosphate and pyrantel as provided by No. 066104 in § 510.600(c) of this chapter 066104 (viii) 40 to 100 For the control of porcine proliferative enteropathies (PPE, ileitis) associated with Lawsonia intracellularis immediately after medicating with tylosin in drinking water Administer as tylosin phosphate in feed continuously as the sole ration for 2 to 6 weeks, immediately after treatment with tylosin tartrate in drinking water for 3 to 10 days as in § 520.2640(d)(3) of this chapter 016592 054771 058198 066104 Start Printed Page 95017 (ix) 40 to 100 Pyrantel, 96 For the control of porcine proliferative enteropathies (PPE, ileitis) associated with Lawsonia intracellularis immediately after medicating with tylosin in drinking water; and as an aid in the prevention of migration and establishment of large roundworm (Ascaris suum) infections; aid in the prevention of establishment of nodular worm (Oesophagostomum spp.) infections Administer as tylosin phosphate in feed continuously as the sole ration for 2 to 6 weeks, immediately after treatment with tylosin tartrate in drinking water for 3 to 10 days as in § 520.2640(d)(3) of this chapter. Tylosin phosphate and pyrantel as provided by No. 066104 in § 510.600(c) of this chapter 066104 (x) 40 to 100 Ractopamine, 4.5 to 9.0 Finishing swine: For the treatment and control of swine dysentery associated with Brachyspira hyodysenteriae, for control of porcine proliferative enteropathies (PPE, ileitis) associated with Lawsonia intracellularis; and for increased rate of weight gain, improved feed efficiency, and increased carcass leanness in finishing swine weighing not less than 150 lbs, fed a complete ration containing at least 16% crude protein for the last 45 to 90 lbs of gain prior to slaughter Feed continuously as the sole ration to finishing swine weighing not less than 150 lbs for the last 45 to 90 lbs (group average) of weight gain prior to slaughter. Include 40 to 100 grams of tylosin phosphate per ton of complete feed for 2 to 6 weeks, immediately after treatment with tylosin tartrate in drinking water for 3 to 10 days as in § 520.2640(d)(3) of this chapter. Tylosin phosphate as provided by Nos. 058198 and 016592; ractopamine as provided by Nos. 058198 and 054771 in § 510.600(c) of this chapter 016592 054771 058198 (xi) 100 For reduction in severity of effects of atrophic rhinitis Feed continuously as the sole ration 016592 054771 058198 066104 (xii) 100 Pyrantel, 96 For reduction in severity of effects of atrophic rhinitis; aid as an aid in the prevention of migration and establishment of large roundworm (Ascaris suum) infections; aid in the prevention of establishment of nodular worm (Oesophagostomum spp.) infections Feed continuously as the sole ration. Tylosin phosphate and pyrantel as provided by No. 066104 in § 510.600(c) of this chapter. Tylosin phosphate and pyrantel as provided by No. 066104 in § 510.600(c) of this chapter 066104 (xiii) 100 Ractopamine, 4.5 to 9.0 For the control of porcine proliferative enteropathies (PPE, ileitis) associated with Lawsonia intracellularis; and for increased rate of weight gain, improved feed efficiency, and increased carcass leanness in finishing swine weighing not less than 150 lbs, fed a complete ration containing at least 16% crude protein for the last 45 to 90 lbs of gain prior to slaughter Feed continuously as the sole ration to finishing swine weighing not less than 150 lbs for the last 45 to 90 lbs (group average) of weight gain prior to slaughter. Include 100 g/ton of tylosin for 3 weeks. Tylosin phosphate as provided by Nos. 058198 and 016592; ractopamine as provided by Nos. 058198 and 054771 in § 510.600(c) of this chapter 016592 054771 058198 (2) Cattle—
Tylosin grams/ton Combination in grams/ton Indications for use Limitations Sponsors (i) 8 to 10 Beef cattle: For reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes Feed continuously as the sole ration to provide 60 to 90 mg/head/day tylosin 016592, 054771, 058198, 066104 Start Printed Page 95018 (ii) 90 to 360 Lasalocid, 100 to 1440 plus melengestrol, 0.25 to 2.0 Heifers fed in confinement for slaughter: For reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium pyogenes; and for increased rate of weight gain, improved feed efficiency, and suppression of estrus (heat) Feed continuously as sole ration. Feed to heifers at the rate of 0.5 to 2.0 pound(s) per head per day (specify one level) to provide 0.25 to 0.5 mg melengestrol acetate per head per day (specify one level), 100 to 360 mg lasalocid per head per day (specify one level), and 90 mg tylosin per head per day. This Type C product may be top dressed onto or mixed into a complete feed prior to feeding. Tylosin as provided by Nos. 058198 and 016592; lasalocid as provided by No. 054771; melengestrol as provided by Nos. 054771 and 058198 in § 510.600(c) of this chapter 054771 016592 (iii) 90 to 360 Melengestrol, 0.25 to 2.0 Heifers fed in confinement for slaughter: For reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium pyogenes; and for increased rate of weight gain, improved feed efficiency, and suppression of estrus (heat) Feed continuously as sole ration. Each pound contains 0.125 to 1.0 mg melengestrol acetate and 45 to 180 mg of tylosin. Feed to heifers at a rate of 0.5 to 2.0 pounds per head per day to provide 0.25 to 0.5 mg melengestrol acetate and 60 to 90 mg tylosin per head per day. Prior to feeding, this Type C product must be top-dressed onto a complete feed or mixed into the amount of complete feed consumed by an animal per day. Tylosin provided by No. 058198; melengestrol provided by No. 054771 in § 510.600(c) of this chapter 054771 (iv) 8 to 10 Monensin, 5 to 40 Cattle fed in confinement for slaughter: For reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes; and for improved feed efficiency Feed continuously as sole ration to provide 50 to 480 monensin mg/head/day and 60 to 90 mg/head/day tylosin. A withdrawal time has not been established for pre-ruminating calves. Do not use in calves to be processed for veal. Tylosin provided by Nos. 016592 or 058198; monensin as provided by No. 058198 in § 510.600(c) of this chapter 016592 058198 (v) 8 to 10 Monensin, 10 to 40 Cattle fed in confinement for slaughter: For reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes; and for prevention of coccidiosis caused by Eimeria bovis and E zuernii Feed continuously as sole ration to provide 0.14 to 0.42 mg monensin/lb body weight per day, depending on the severity of the coccidiosis challenge, up to 480 mg/head/day and 60 to 90 mg/head/day tylosin. A withdrawal time has not been established for pre-ruminating calves. Do not use in calves to be processed for veal. Tylosin provided by Nos. 016592 or 058198; monensin as provided by No. 058198 in § 510.600(c) of this chapter 016592 058198 (vi) 8 to 10 Monensin, 5 to 30 plus decoquinate, 13.6 to 22.7 Cattle fed in confinement for slaughter: For reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium pyogenes; for the prevention of coccidiosis caused by Eimeria bovis and E. zuernii; and for improved feed efficiency Feed continuously as the sole ration to provide 22.7 mg of decoquinate per 100 lb body weight per day, 50 to 360 mg of monensin/head/day, and 60 to 90 mg of tylosin/head/day. Feed at least 28 days during period of exposure to coccidiosis or when it is likely to be a hazard. Do not feed to animals producing milk for food. Do not feed to lactating dairy cattle. A withdrawal time has not been established for pre-ruminating calves. Do not use in calves to be processed for veal. Tylosin as provided by Nos. 016592 and 058198; monensin as provided by No. 058198; decoquinate as provided by No. 058198 in § 510.600(c) of this chapter 016592 054771 Start Printed Page 95019 (vii) 8 to 10 Monensin, 10 to 40 plus melengestrol, 0.25 to 2.0 Heifers fed in confinement for slaughter: For reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes; for prevention and control of coccidiosis caused by Eimeria bovis and E zuernii; and for increased rate of weight gain, improved feed efficiency, and suppression of estrus (heat) Feed continuously as sole ration to heifers at a rate of 0.5 to 2.0 pounds per head per day to provide 0.25 to 0.5 mg/head/day melengestrol acetate and 0.14 to 0.42 mg monensin/lb body weight per day, depending on the severity of the coccidiosis challenge, up to 480 mg/head/day and 60 to 90 mg/head/day tylosin. The melengestrol acetate portion of this Type C medicated feed must be mixed into the complete feed containing 10 to 40 g/ton monensin and 8 to 10 g/ton tylosin at feeding into the amount of complete feed consumed by an animal per day. A withdrawal time has not been established for pre-ruminating calves. Do not use in calves to be processed for veal. Tylosin provided by Nos. 016592 or 058198; monensin as provided by No. 058198; melengestrol provided by Nos. 054771 or 058198 in § 510.600(c) of this chapter 016592 054771 058198 (viii) 8 to 10 Monensin, 10 to 40 plus ractopamine, 8.2 to 24.6 Cattle fed in confinement for slaughter: For reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium pyogenes; for prevention and control of coccidiosis caused by Eimeria bovis and E zuernii; and for increased rate of weight gain and improved feed efficiency in cattle fed in confinement for slaughter for the last 28 to 42 days on feed Feed continuously as sole ration to provide 70 to 430 mg/head/day ractopamine and 0.14 to 0.42 mg monensin/lb body weight per day, depending on the severity of the coccidiosis challenge, up to 480 mg/head/day and 60 to 90 mg/head/day tylosin for the last 28 to 42 days on feed. A withdrawal time has not been established for pre-ruminating calves. Do not use in calves to be processed for veal. Tylosin provided by Nos. 016592 or 058198; monensin as provided by No. 058198; ractopamine provided by Nos. 054771 or 058198 in § 510.600(c) of this chapter 054771 058198 (ix) 8 to 10 Monensin, 10 to 40 plus ractopamine, not to exceed 800 Cattle fed in confinement for slaughter: For reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium pyogenes; for prevention and control of coccidiosis caused by Eimeria bovis and E zuernii; and for increased rate of weight gain and improved feed efficiency in cattle fed in confinement for slaughter for the last 28 to 42 days on feed Feed a minimum of 1.0 lb/head/day ractopamine Type C top dress feed continuously to cattle fed in confinement for slaughter, to provide 70 to 400 mg/head/day ractopamine for the last 28 to 42 days on feed. Feed on top of a ration containing 10 to 40 g/ton monensin and 8 to 10 g/ton tylosin phosphate, to provide 0.14 to 0.42 mg monensin/lb body weight/day, depending on the severity of the coccidiosis challenge, up to 480 mg/head/day and 60 to 90 mg/head/day tylosin. A withdrawal time has not been established for pre-ruminating calves. Do not use in calves to be processed for veal. Tylosin provided by Nos. 016592 or 058198; monensin as provided by No. 058198; ractopamine provided by Nos. 054771 or 058198 in § 510.600(c) of this chapter 054771 058198 Start Printed Page 95020 (x) 8 to 10 Monensin 10 to 40 plus ractopamine 9.8 to 24.6 Cattle fed in confinement for slaughter: For reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium pyogenes; for prevention and control of coccidiosis caused by Eimeria bovis and E zuernii; and for increased rate of weight gain, improved feed efficiency, and increased carcass leanness in cattle fed in confinement for slaughter for the last 28 to 42 days on feed Feed continuously as sole ration to provide 90 to 430 mg/head/day ractopamine and 0.14 to 0.42 mg monensin/lb body weight per day, depending on the severity of the coccidiosis challenge, up to 480 mg/head/day and 60 to 90 mg/head/day tylosin for the last 28 to 42 days on feed. A withdrawal time has not been established for pre-ruminating calves. Do not use in calves to be processed for veal. Tylosin provided by Nos. 016592 or 058198; monensin as provided by No. 058198; ractopamine as provided by Nos. 054771 or 058198 in § 510.600(c) of this chapter 054771 058198 (xi) 8 to 10 Monensin, 10 to 40 plus ractopamine, 9.8 to 24.6 plus melengestrol, 0.125 to 1 mg/lb Heifers fed in confinement for slaughter: For reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes; for prevention and control of coccidiosis caused by Eimeria bovis and E zuernii; for increased rate of weight gain, improved feed efficiency, and increased carcass leanness; and suppression of estrus (heat) Feed continuously as sole ration to provide 90 to 430 mg/head/day ractopamine and 0.14 to 0.42 mg monensin/lb body weight per day, depending on the severity of the coccidiosis challenge, up to 480 mg/head/day and 60 to 90 mg/head/day tylosin for the last 28 to 42 days on feed. Feed melengestrol as a top dress or mixed with a complete ration at the rate of 0.5 to 2.0 pound/head/day (specify one level) to provide 0.25 to 0.5 mg melengestrol acetate/head/day (specify one level). A withdrawal time has not been established for pre-ruminating calves. Do not use in calves to be processed for veal. Tylosin provided by Nos. 016592 or 058198; monensin as provided by No. 058198; ractopamine as provided by Nos. 054771 or 058198 in § 510.600(c) of this chapter 054771 058198 (xii) 8 to 10 Monensin, 10 to 40 plus zilpaterol, 6.8 Cattle fed in confinement for slaughter: For reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium pyogenes; for prevention and control of coccidiosis caused by Eimeria bovis and E zuernii; and for increased rate of weight gain, improved feed efficiency, and increased carcass leanness in cattle fed in confinement for slaughter for the last 20 to 40 days on feed Feed continuously as the sole ration to cattle during the last 20 to 40 days on feed to provide 60 to 90 mg/head/day zilpaterol, 0.14 to 0.42 mg/lb body weight/day monensin, depending on the severity of the coccidiosis challenge, up to 480 mg/head/day monensin, and 60 to 90 mg/head/day tylosin. Do not use in veal calves. Withdrawal period 3 days. Tylosin provided by Nos. 016592 or 058198; monensin as provided by No. 058198; zilpaterol as provided by No. 000061 in § 510.600(c) of this chapter 000061 016592 (xiii) 8 to 10 Monensin, 10 to 40 plus zilpaterol, 6.8 to 24 Cattle fed in confinement for slaughter: For reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium pyogenes; for prevention and control of coccidiosis caused by Eimeria bovis and E zuernii; and for increased rate of weight gain, improved feed efficiency, and increased carcass leanness in cattle fed in confinement for slaughter for the last 20 to 40 days on feed Feed this component feed continuously to cattle during the last 20 to 40 days on feed to provide 60 mg/head/day zilpaterol, 0.14 to 0.42 mg/lb body weight/day monensin, depending on the severity of the coccidiosis challenge, up to 480 mg/head/day monensin, and 60 to 90 mg/head/day tylosin. Do not use in veal calves. Withdrawal period 3 days. Tylosin provided by Nos. 016592 or 058198; monensin as provided by No. 058198; zilpaterol as provided by No. 000061 in § 510.600(c) of this chapter 000061 016592 Start Printed Page 95021 (xiv) 8 to 10 Monensin, 10 to 40 plus zilpaterol, 6.8 plus melengestrol, 0.125 to 1 mg/lb Heifers fed in confinement for slaughter: For reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes; for prevention and control of coccidiosis caused by Eimeria bovis and E zuernii; and for increased rate of weight gain, improved feed efficiency, and increased carcass leanness in cattle fed in confinement for slaughter for the last 20 to 40 days on feed; and for suppression of estrus (heat) Feed continuously as the sole ration to cattle during the last 20 to 40 days on feed to provide 60 to 90 mg/head/day zilpaterol, 0.14 to 0.42 mg/lb body weight/day monensin, depending on the severity of the coccidiosis challenge, up to 480 mg/head/day monensin, and 60 to 90 mg/head/day tylosin. Feed melengestrol as a top dress or mixed with a complete ration at the rate of 0.5 to 2.0 pound/head/day (specify one level) to provide 0.25 to 0.5 mg melengestrol acetate/head/day (specify one level). Do not use in veal calves. Withdrawal period 3 days. Tylosin as provided by Nos. 016592 or 058198; monensin as provided by No. 058198; zilpaterol as provided by No. 000061; melengestrol provided by Nos. 054771 or 058198 in § 510.600(c) of this chapter 000061 016592 058198 (xv) 8 to 10 Monensin, 10 to 40 plus zilpaterol, 6.8 to 24 plus melengestrol, 0.125 to 1 mg/lb Heifers fed in confinement for slaughter: For reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes; for prevention and control of coccidiosis caused by Eimeria bovis and E zuernii; and for increased rate of weight gain, improved feed efficiency, and increased carcass leanness in cattle fed in confinement for slaughter for the last 20 to 40 days on feed; and for suppression of estrus (heat) Feed this component feed continuously to cattle during the last 20 to 40 days on feed to provide 60 mg/head/day zilpaterol, 0.14 to 0.42 mg/lb body weight/day monensin, depending on the severity of the coccidiosis challenge, up to 480 mg/head/day monensin, and 60 to 90 mg/head/day tylosin. Feed melengestrol as a top dress or mixed with a complete ration at the rate of 0.5 to 2.0 pound/head/day (specify one level) to provide 0.25 to 0.5 mg melengestrol acetate/head/day (specify one level). Do not use in veal calves. Withdrawal period 3 days. Tylosin as provided by Nos. 016592 or 058198; monensin as provided by No. 058198; zilpaterol as provided by No. 000061; melengestrol provided by Nos. 054771 or 058198 in § 510.600(c) of this chapter 000061 016592 058198 40. Revise § 558.630 to read as follows:
End Amendment PartStart Amendment PartTylosin 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 § 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 §§ 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 § 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:Start Printed Page 95022
Tylosin phosphate and sulfamethazine in grams/ton Combination in grams/ton Indications for use Limitations Sponsors (1) 100 each For reduction in the severity of effects of atrophic rhinitis; lowering the incidence and severity of Bordetella bronchiseptica rhinitis; prevention of swine dysentery associated with Brachyspira hyodysenteriae; control of swine pneumonias caused by bacterial pathogens (Pasteurella multocida and/or Arcanobacterium pyogenes); reducing the incidence of cervical lymphadenitis (jowl abscesses) caused by Group E Streptococci. Only the sulfamethazine portion of this combination is active in controlling jowl abscesses Withdraw 15 days before swine are slaughtered 058198 (2) 100 each For reduction in the severity of effects of atrophic rhinitis; lowering the incidence and severity of Bordetella bronchiseptica rhinitis; prevention of swine dysentery associated with Brachyspira hyodysenteriae; and control of swine pneumonias caused by bacterial pathogens (Pasteurella multocida and/or Arcanobacterium pyogenes) Withdraw 15 days before swine are slaughtered 054771 41. Revise § 558.635 to read as follows:
End Amendment PartStart Printed Page 95025 Start Amendment PartVirginiamycin.(a) Specifications. Type A medicated articles containing 5, 10, 20, 50, 136.2, or 227 grams per pound virginiamycin.
(b) Sponsors. See No. 066104 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.750 of this chapter.
(d) Special considerations—(1) [Reserved]
(2) [Reserved]
(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—
Start Printed Page 95024Virginiamycin grams/ton Combination in grams/ton Indications for use Limitations Sponsors (i) 5 Broiler chickens: For increased rate of weight gain and improved feed efficiency Not for use in layers 066104 (ii) 5 Monensin, 90 to 110 Broiler chickens: For increased rate of weight gain and improved feed efficiency; as an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. maxima, and E. mivati Feed continuously as the sole ration. Do not feed to laying chickens. Virginiamycin as provided by No. 066104; monensin as provided by No. 058198 in § 510.600(c) of this chapter 066104 (iii) 5 Salinomycin, 40 to 60 Broiler chickens: For increased rate of weight gain and improved feed efficiency; for prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati Feed continuously as the sole ration. Do not feed to layers or to chickens over 16 weeks of age. Not approved for use with pellet binders. May be fatal if accidentally fed to adult turkeys or horses. Virginiamycin as provided by No. 066104; salinomycin as provided by No. 054771 in § 510.600(c) of this chapter 066104 016592 (iv) 5 Semduramicin, 22.7 Broiler chickens: For increased rate of weight gain and improved feed efficiency; for the prevention of coccidiosis caused by Eimeria acervulina, E. brunetti, E. maxima, E. mivati/mitis, E. necatrix, and E. tenella Feed continuously as the sole ration. Do not feed to laying hens. Semduramicin as provided by No. 066104 in § 510.600(c) of this chapter 066104 (v) 5 Semduramicin (biomass), 22.7 Broiler chickens: For increased rate of weight gain and improved feed efficiency; for the prevention of coccidiosis caused by Eimeria acervulina, E. brunetti, E. maxima, E. mivati/mitis, E. necatrix, and E. tenella Feed continuously as the sole ration. Withdraw 1 day before slaughter. Do not feed to laying hens. Virginiamycin and semduramicin as provided by No. 066104 in § 510.600(c) of this chapter 066104 (vi) 5 to 15 Broiler chickens: For increased rate of weight gain Not for use in layers 066104 Start Printed Page 95023 (vii) 5 to 15 Amprolium, 113.5 and ethopabate, 36.3 Broiler chickens: For increased rate of weight gain; as an aid in the prevention of coccidiosis where severe exposure to coccidiosis from Eimeria acervulina, E. maxima, and E. brunetti is likely to occur Feed continuously as the sole ration and as the sole source of amprolium. Do not feed to laying chickens. Not for chickens over 16 weeks of age. Virginiamycin as provided by No. 066104; amprolium and ethopabate as provided by No. 016592 in § 510.600(c) of this chapter 066104 (viii) 5 to 15 Monensin, 90 to 110 Broiler chickens: For increased rate of weight gain; as an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. maxima, and E. mivati Feed continuously as the sole ration. Do not feed to laying chickens. Monensin as provided by No. 000986 in § 510.600(c) of this chapter 066104 (ix) 5 to 15 Salinomycin, 40 to 60 Broiler chickens: For increased rate of weight gain; as an aid in the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati Feed continuously as the sole ration. Do not feed to layers or to chickens over 16 weeks of age. Not approved for use with pellet binders. May be fatal if accidentally fed to adult turkeys or horses. Virginiamycin as provided by No. 066104; salinomycin as provided by Nos. 016592 or 054771 in § 510.600(c) of this chapter 016592 066104 (x) 5 to 15 Semduramicin, 22.7 Broiler chickens: For increased rate of weight gain; for the prevention of coccidiosis caused by Eimeria acervulina, E. brunetti, E. maxima, E. mivati/mitis, E. necatrix, and E. tenella Feed continuously as the sole ration. Do not feed to laying hens. Semduramicin as provided by No. 066104 in § 510.600(c) of this chapter 066104 (xi) 5 to 15 Semduramicin (biomass), 22.7 Broiler chickens: For increased rate of weight gain; for the prevention of coccidiosis caused by Eimeria acervulina, E. brunetti, E. maxima, E mivati/mitis, E. necatrix, and E. tenella Feed continuously as the sole ration. Withdraw 1 day before slaughter. Do not feed to laying hens. Virginiamycin as provided by No. 066104; semduramicin as provided by No. 066104 in § 510.600(c) of this chapter 066104 (xii) 15 Amprolium, 113.5 and ethopabate, 36.3 Broiler chickens: For increased rate of weight gain and improved feed efficiency; as an aid in the prevention of coccidiosis where severe exposure to coccidiosis from Eimeria acervulina, E. maxima, and E. brunetti is likely to occur Feed continuously as the sole ration and as the sole source of amprolium. Do not feed to laying chickens. Not for chickens over 16 weeks of age. Virginiamycin as provided by No. 066104; amprolium and ethopabate as provided by No. 016592 in § 510.600(c) of this chapter 066104 (xiii) 20 Broiler chickens: For prevention of necrotic enteritis caused by Clostridium spp. susceptible to virginiamycin Not for use in layers 066104 (xiv) 20 Lasalocid, 68 to 113 Broiler chickens: For increased rate of weight gain and improved feed efficiency; for prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxima Feed continuously as the sole ration. Do not feed to laying chickens. Lasalocid sodium as provided by No. 054771 in § 510.600(c) of this chapter 066104 (xv) 20 Monensin, 90 to 110 Broiler chickens: For prevention of necrotic enteritis caused by Clostridium spp. susceptible to virginiamycin; and as an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. maxima, and E. mivati Feed continuously as the sole ration. Do not feed to laying chickens. Monensin as provided by No. 058198 in § 510.600(c) of this chapter 066104 (xvi) 20 Semduramicin, 22.7 Broiler chickens: For prevention of necrotic enteritis caused by Clostridium spp. susceptible to virginiamycin; for the prevention of coccidiosis caused by Eimeria acervulina, E. brunetti, E. maxima, E. mivati/mitis, E. necatrix, and E. tenella Feed continuously as the sole ration. Do not feed to laying hens. Semduramicin as provided by No. 066104 in § 510.600(c) of this chapter 066104 (xvii) 20 Semduramicin (biomass), 22.7 Broiler chickens: For prevention of necrotic enteritis caused by Clostridium spp. susceptible to virginiamycin; for the prevention of coccidiosis caused by Eimeria acervulina, E. brunetti, E. maxima, E. mivati/mitis, E. necatrix, and E. tenella Feed continuously as the sole ration. Withdraw 1 day before slaughter. Do not feed to laying hens. Semduramicin as provided by No. 066104 in § 510.600(c) of this chapter 066104 (2) Turkeys—
Virginiamycin grams/ton Combination in grams/ton Indications for use Limitations Sponsors (i) 10 to 20 Growing turkeys: For increased rate of weight gain and improved feed efficiency Not for use in layers 066104 (ii) 10 to 20 Lasalocid, 68 to 113 Growing turkeys: For increased rate of weight gain and improved feed efficiency; and for the prevention of coccidiosis caused by Eimeria meleagrimitis, E. gallopavonis, and E. adenoeides Lasalocid sodium as provided by No. 054771 in § 510.600(c) of this chapter 054771 (iii) 10 to 20 Monensin, 90 to 110 Growing turkeys: For increased rate of weight gain and improved feed efficiency; and for the prevention of coccidiosis caused by Eimeria meleagrimitis, E. gallopavonis, and E. adenoeides Monensin as provided by No. 058198 in § 510.600(c) of this chapter 066104 (3) Swine—
Virginiamycin grams/ton Combination in grams/ton Indications for use Limitations Sponsors (i) 5 or 10 Growing-finishing swine: For increased rate of weight gain and improved feed efficiency Feed continuously from weaning to market weight. Feed 10 grams per ton from weaning up to 120 pounds, followed by 5 grams per ton to market weight 066104 (ii) 5 to 10 Growing-finishing swine: For increased rate of weight gain Feed continuously from weaning to market weight. Feed 10 grams per ton from weaning up to 120 pounds for increased rate of weight gain and improved feed efficiency, followed by 5 to 10 grams per ton to market weight for increased rate of weight gain 066104 (iii) 25 Growing-finishing swine: As an aid in control of dysentery in swine up to 120 pounds in animals or on premises with a history of swine dysentery but where symptoms have not yet occurred 066104 (iv) 50 or 100 Growing-finishing swine: For treatment and control of swine dysentery in swine up to 120 pounds Feed 100 grams per ton for 2 weeks, 50 grams per ton thereafter 066104 (v) 100 Growing-finishing swine: For treatment of swine dysentery in nonbreeding swine over 120 pounds Feed for 2 weeks 066104 (4) Cattle—
Virginiamycin grams/ton Combination in grams/ton Indications for use Limitations Sponsors (i) 11.0 to 16.0 Cattle fed in confinement for slaughter: For improved feed efficiency Feed continuously as the sole ration to provide 70 to 240 milligrams per head per day. Not for use in animals intended for breeding 066104 (ii) 13.5 to 16.0 Cattle fed in confinement for slaughter: For reduction of incidence of liver abscesses Feed continuously as the sole ration to provide 85 to 240 milligrams per head per day. Not for use in animals intended for breeding 066104 (iii) 16.0 to 22.5 Cattle fed in confinement for slaughter: For increased rate of weight gain Feed continuously as the sole ration to provide 100 to 340 milligrams per head per day. Not for use in animals intended for breeding 066104 42. In § 558.665, remove and reserve paragraphs (e)(5) and (6); remove paragraphs (e)(11) and (12); and add paragraph (f) to read as follows:
End Amendment PartStart Amendment PartZilpaterol.* * * * *(f) Zilpaterol may also be used in combination with tylosin as in § 558.625.
43. In § 558.680, remove paragraph (d)(1)(x); and add paragraph (e)(3) to read as follows:
End Amendment PartStart SignatureZoalene.* * * * *(e) * * *
(3) Zoalene may also be used in combination with lincomycin as in § 558.325.
End Signature End Supplemental InformationDated: 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
Document Information
- Effective Date:
- 12/30/2016
- Published:
- 12/27/2016
- Department:
- Food and Drug Administration
- Entry Type:
- Rule
- Action:
- Final rule; technical amendment.
- Document Number:
- 2016-31083
- Dates:
- This rule is effective December 30, 2016.
- Pages:
- 94991-95025 (35 pages)
- Docket Numbers:
- Docket No. FDA-2016-N-0002
- Topics:
- Animal drugs, Animal feeds, Foods
- PDF File:
- 2016-31083.pdf
- Supporting Documents:
- » FOI Summary sN 141-452 approved December 12 2016
- » FOI Summary sN 141-443, approved November 16, 2016
- » FOI Summary oN 141-475 approved December 29 2016
- » FOI Summary oN 141-474 approved November 10 2016
- » FOI Summary oN 141-473 approved December 16 2016
- » FOI Summary oA 200-589 approved December 21 2016
- » FOI Summary oA 200-596, approved May 24, 2016 re New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship
- » FOI Summary oN 141-463, approved May 17, 2016 re New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship
- » FOI Summary oN 141-457, approved May 16, 2016 re New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship
- » FOI Summary oN 141-439, approved May 2, 2016 re New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship
- CFR: (41)
- 21 CFR 556.480
- 21 CFR 558.4
- 21 CFR 558.58
- 21 CFR 558.59
- 21 CFR 558.76
- More ...