Page Range | 11510-11513 | |
FR Document | 2017-03596 |
[Federal Register Volume 82, Number 36 (Friday, February 24, 2017)] [Rules and Regulations] [Pages 11510-11513] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-03596] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 558 [Docket No. FDA-2016-N-0002] New Animal Drugs for Use in Animal Feed; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; technical amendment. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of eight supplemental new animal drug applications (NADAs). The effect of these supplemental applications will be to change the marketing status from over-the- counter (OTC) use to use by veterinary feed directive (VFD) for these 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 production 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 abbreviated new animal drug applications (ANADAs) that were affected by this initiative. DATES: This rule is effective February 24, 2017. FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5689, [email protected]. SUPPLEMENTARY INFORMATION: I. Supplemental Approval of Revised Labeling and Withdrawal of Approval of Portions of NADAs Pertaining to Production Indications FDA is amending the animal drug regulations to reflect approval of eight supplemental NADAs 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 production 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 [[Page 11511]] 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 from OTC to VFD marketing status is consistent with FDA CVM's initiative for the Judicious Use of Antimicrobials. The affected applications for Type A medicated articles for which supplemental applications with revised labeling were approved are as follows: ------------------------------------------------------------------------ File No. Animal drug product Sponsor ------------------------------------------------------------------------ 091-467................ STAFAC 500 Phibro Animal Health (virginiamycin) Type A Corp., GlenPointe Medicated Article. Centre East, 3d Floor, 300 Frank W. Burr Blvd., Suite 21, Teaneck, NJ 07666 (Phibro Animal Health Corp.). 140-998................ V-MAX (virginiamycin) Phibro Animal Health Type A Medicated Corp. Article. ------------------------------------------------------------------------ The affected applications for manufacturing combination drug medicated feeds follow: ------------------------------------------------------------------------ File No. Animal drug product Sponsor ------------------------------------------------------------------------ 046-718................ TERRAMYCIN Zoetis Inc., 333 (oxytetracycline)/MGA Portage St., (melengestrol acetate). Kalamazoo, MI 49007 (Zoetis Inc.). 046-719................ TERRAMYCIN Zoetis Inc. (oxytetracycline)/MGA (melengestrol acetate). 140-579................ TERRAMYCIN Zoetis Inc. (oxytetracycline)/ BOVATEC (lasalocid). 141-114................ STAFAC (virginiamycin)/ Phibro Animal Health AVIAX (semduramicin). Corp. 141-289................ STAFAC (virginiamycin)/ Phibro Animal Health AVIAX II Corp. (semduramicin) (biomass). 141-430................ STAFAC (virginiamycin)/ Phibro Animal Health COBAN (monensin). Corp. ------------------------------------------------------------------------ II. Withdrawals of Approval At the sponsors' requests, approval of applications is being withdrawn for medicated feeds containing antimicrobial drugs of importance to human medicine administered to food-producing animals because these products are no longer manufactured or marketed. The applications being withdrawn are as follows: ------------------------------------------------------------------------ File No. Product name Sponsor ------------------------------------------------------------------------ 044-820................ LINCOMIX (lincomycin)/ Zoetis Inc., 333 AMPROL PLUS (amprolium Portage St., and ethopabate). Kalamazoo, MI 49007 (Zoetis Inc.). 044-972................ LINCOMIX (lincomycin)/ Zoetis Inc. COYDEN (clopidol). 047-261................ LINCOMIX (lincomycin)/ Zoetis Inc. DECCOX (decoquinate). 047-262................ LINCOMIX (lincomycin)/ Zoetis Inc. DECCOX (decoquinate). 048-954................ LINCOMIX (lincomycin)/ Zoetis Inc. ZOAMIX (zoalene). 091-513................ STAFAC (virginiamycin) Phibro Animal Health Type A Medicated Corp., GlenPointe Article. Centre East, 3d Floor, 300 Frank W. Burr Blvd., Suite 21, Teaneck, NJ 07666 (Phibro Animal Health Corp.). 092-482................ LINCOMIX (lincomycin)/ Zoetis Inc. COBAN (monensin). 093-106................ LINCOMIX (lincomycin)/ Zoetis Inc. ROBENZ (robenidine). 101-689................ LINCOMIX (lincomycin)/ Zoetis Inc. AVATEC (lasalocid). 122-481................ STAFAC (virginiamycin)/ Phibro Animal Health COBAN (monensin). Corp. 122-608................ STAFAC (virginiamycin)/ Phibro Animal Health AVATEC (lasalocid). Corp. 122-822................ STAFAC (virginiamycin)/ Phibro Animal Health AMPROL PLUS (amprolium Corp. and ethopabate). 137-537................ LINCOMIX (lincomycin)/ Zoetis Inc. BIO-COX (salinomycin). 138-792................ TYLAN (tylosin)/ Zoetis Inc. RUMENSIN (monensin)/ MGA (melengestrol acetate). 138-828................ STAFAC (virginiamycin)/ Phibro Animal Health BIO-COX (salinomycin). Corp. 138-904................ TYLAN (tylosin)/BOVATEC Zoetis Inc. (lasalocid)/MGA (melengestrol acetate). 141-110................ STAFAC (virginiamycin)/ Phibro Animal Health COBAN (monensin). Corp. 141-150................ STAFAC (virginiamycin)/ Phibro Animal Health AVATEC (lasalocid). Corp. 200-092................ STAFAC (virginiamycin)/ Huvepharma EOOD, 5th SACOX (salinomycin). Floor, 3A Nikolay Haytov Str., 1113 Sophia, Bulgaria (Huvepharma EOOD). 200-093................ LINCOMIX (lincomycin)/ Huvepharma EOOD. SACOX (salinomycin). ------------------------------------------------------------------------ Elsewhere in this issue of the Federal Register, FDA gave notice that approval of NADAs 044-820, 044-972, 047-261, 047-262, 048-954, 091-513, 092-482, 093-106, 101-689, 122-481, 122-608, 122-822, 137-537, 138-792, 138-828, 138-904, 141-110, and 141-150, and ANADAs 200-092 and 200-093, and all supplements and amendments thereto, is withdrawn, effective February 24, 2017. As provided in the regulatory text of this document, the animal drug [[Page 11512]] regulations are amended to reflect these voluntary withdrawals of approval. A similar rule published in the Federal Register of December 27, 2016 (81 FR 94991), amended the approved conditions of use in 21 CFR part 558 to reflect approval of an additional 106 supplemental NADAs and supplemental ANADAs for the manufacture of medicated feeds for administration of antimicrobial drugs to food-producing animals and the voluntary withdrawal of approval of 11 NADAs and 4 ANADAs. This rule does not meet the definition of ``rule'' in 5 U.S.C. 804(3)(A) because it is a rule of ``particular applicability.'' Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808. List of Subjects in 21 CFR 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 part 558 is amended as follows: PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS 0 1. The authority citation for part 558 continues to read as follows: Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371. 0 2. In Sec. 558.450, redesignate paragraph (e)(4)(iii) as paragraph (e)(4)(v) and add paragraphs (e)(4)(iii) and (iv) to read as follows: Sec. 558.450 Oxytetracycline. * * * * * (e) * * * (4) Cattle-- ---------------------------------------------------------------------------------------------------------------- Combination in grams/ Oxytetracycline amount ton Indications for use Limitations Sponsor ---------------------------------------------------------------------------------------------------------------- * * * * * * * (iii) 75 mg/head/day.............. Lasalocid 25 to 30.. Heifers fed in Feed continuously to 054771 confinement for provide 250 to 360 slaughter (over 400 mg lasalocid and 75 lb): For reduction mg of of incidence of oxytetracycline per liver abscesses; head per day. and for increased Lasalocid as rate of weight gain provided by No. and improved feed 054771 in Sec. efficiency. 510.600(c) of this chapter. (iv) 75 mg/head/day............... Melengestrol Heifers fed in Feed continuously to 054771 acetate, 0.25 to confinement for provide 0.25 to 0.5 2.0. slaughter (over 400 mg of melengestrol lb): For reduction acetate and 75 mg of incidence of of oxytetracycline liver abscesses; per head per day. and for increased Melengestrol as rate of weight provided by No. gain, improved feed 054771 in Sec. efficiency, and 510.600(c) of this suppression of chapter. estrus (heat). * * * * * * * ---------------------------------------------------------------------------------------------------------------- * * * * * 0 3. In Sec. 558.635, revise paragraphs (a) and (e) and add paragraphs (d)(1) and (2) to read as follows: Sec. 558.635 Virginiamycin. (a) Specifications. Type A medicated articles containing 10, 20, 50, or 227 grams virginiamycin per pound. * * * * * (d) Special considerations. (1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian. See Sec. 558.6 for additional requirements. (2) The expiration date of VFDs for virginiamycin medicated feeds must not exceed 6 months from the date of issuance. VFDs for virginiamycin shall not be refilled. * * * * * (e) Conditions of use--(1) Chickens-- ---------------------------------------------------------------------------------------------------------------- Combination in grams/ Virginiamycin grams/ton ton Indications for use Limitations Sponsor ---------------------------------------------------------------------------------------------------------------- (i) 20............................ .................... Broiler chickens: Not for use in 066104 For prevention of layers. necrotic enteritis caused by Clostridium spp. susceptible to virginiamycin. (ii)-(vi) [Reserved] (vii) 20.......................... Monensin, 90 to 110. Broiler chickens: Feed continuously as 066104 For prevention of the sole ration. Do necrotic enteritis not feed to laying caused by chickens. Monensin Clostridium spp. as provided by No. susceptible to 058198 in Sec. virginiamycin; and 510.600(c) of this as an aid in the chapter. prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. maxima, and E. mivati. (viii) [Reserved] [[Page 11513]] (ix) 20........................... Semduramicin, 22.7.. Broiler chickens: Feed continuously as 066104 For prevention of the sole ration. Do necrotic enteritis not feed to laying caused by hens. Semduramicin Clostridium spp. as provided by No. susceptible to 066104 in Sec. virginiamycin; for 510.600(c) of this the prevention of chapter. coccidiosis caused by Eimeria acervulina, E. brunetti, E. maxima, E mivati/ mitis, E. necatrix, and E. tenella. (x) 20............................ Semduramicin Broiler chickens: Feed continuously as 066104 (biomass), 22.7. For prevention of the sole ration. necrotic enteritis Withdraw 1 day caused by before slaughter. Clostridium spp. Do not feed to susceptible to laying hens. virginiamycin; for Semduramicin as the prevention of provided by No. coccidiosis caused 066104 in Sec. by Eimeria 510.600(c) of this acervulina, E. chapter. brunetti, E. maxima, E mivati/ mitis, E. necatrix, and E. tenella. ---------------------------------------------------------------------------------------------------------------- (2) Swine-- ---------------------------------------------------------------------------------------------------------------- Combination in grams/ Virginiamycin grams/ton ton Indications for use Limitations Sponsor ---------------------------------------------------------------------------------------------------------------- (i) 25............................ .................... Growing-finishing .................... 066104 swine: As an aid in control of dysentery in swine up to 120 pounds in animals or on premises with a history of swine dysentery but where symptoms have not yet occurred. (ii) 50 or 100.................... .................... Growing-finishing Feed 100 grams per 066104 swine: For ton for 2 weeks, 50 treatment and grams per ton control of swine thereafter. dysentery in swine up to 120 pounds. (iii) 100......................... .................... Growing-finishing Feed for 2 weeks.... 066104 swine: For treatment of swine dysentery in nonbreeding swine over 120 pounds. ---------------------------------------------------------------------------------------------------------------- (3) Cattle-- ---------------------------------------------------------------------------------------------------------------- Combination in grams/ Virginiamycin grams/ton ton Indications for use Limitations Sponsor ---------------------------------------------------------------------------------------------------------------- (i) 13.5 to 16.0.................. .................... Cattle fed in Feed continuously as 066104 confinement for the sole ration to slaughter: For provide 85 to 240 reduction of milligrams per head incidence of liver per day. Not for abscesses. use in animals intended for breeding. (ii) [Reserved] ---------------------------------------------------------------------------------------------------------------- Dated: February 17, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-03596 Filed 2-23-17; 8:45 am] BILLING CODE 4164-01-P
Category | Regulatory Information | |
Collection | Federal Register | |
sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
Publisher | Office of the Federal Register, National Archives and Records Administration | |
Section | Rules and Regulations | |
Action | Final rule; technical amendment. | |
Dates | This rule is effective February 24, 2017. | |
Contact | George K. Haibel, Center for Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5689, [email protected] | |
FR Citation | 82 FR 11510 | |
CFR Associated | Animal Drugs and Animal Feeds |