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Source: DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Final rule; technical amendments.
CFR Part: "21 CFR Parts 510, 520, 522, 524, 556, and 558"
Citation: "83 FR 64738"
Document Number: "Docket No. FDA-2018-N-0002"
Page Number: "64738"
"Rules and Regulations"
Agency: "Food and Drug Administration, HHS."
SUMMARY: The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during April, May, and June 2018. FDA is informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to make technical amendments to improve the accuracy and readability of the regulations.
DATES:
This rule is effective December 18, 2018.
FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for Veterinary Medicine (HFV-6), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-5689, [email protected].
SUPPLEMENTARY INFORMATION:
I. Approval Actions FDA is amending the animal drug regulations to reflect approval actions for NADAs and ANADAs during April, May, and June 2018, as listed in table 1. In addition, FDA is informing the public of the availability, where applicable, of documentation of environmental review required under the National Environmental Policy Act (NEPA) and, for actions requiring review of safety or effectiveness data, summaries of the basis of approval (FOI Summaries) under the Freedom of Information Act (FOIA). These public documents may be seen in the office of the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday. Persons with access to the internet may obtain these documents at the CVM FOIA Electronic Reading Room: https://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CVM/CVMFOIAElectronicReadingRoom/default.htm. Marketing exclusivity and patent information may be accessed in FDA's publication, Approved Animal Drug Products Online (Green Book) at: https://www.fda.gov/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/default.htm.
| Table_1-Original_and_Supplemental_NADAs_and_ANADAs_Approved_During_April,_May,_and_June_2018__________________________________________________________________________________________________________ |
| Approval_date_______________File________________________Sponsor_____________________Product_name________________Species_____________________Effect_of_the_action________Public______________________ |
| ____________________________No._________________________________________________________________________________________________________________________________________documents___________________ |
| May_4,_2018_________________141-481_____________________Kindred_Biosciences,_Inc.,__MIRATAZ_(mirtazapine________Cats________________________Original_approval_for_the___FOI_Summary.________________ |
| ________________________________________________________1555_Bayshore_Hwy.,_Suite___transdermal_ointment)___________________________________management_of_weight_loss_______________________________ |
| ________________________________________________________200,_Burlingame,_CA_94010___________________________________________________________in_cats_________________________________________________ |
| May_15,_2018________________141-501_____________________Boehringer_Ingelheim________SEMINTRA_(telmisartan_oral__Cats________________________Original_approval_for_the___FOI_Summary.________________ |
| ________________________________________________________Vetmedica,_Inc.,_2621_North_solution)_______________________________________________control_of_systemic_____________________________________ |
| ________________________________________________________Belt_Hwy.,_St._Joseph,_MO___________________________________________________________hypertension_in_cats____________________________________ |
| ________________________________________________________64506-2002__________________________________________________________________________________________________________________________________ |
| May_25,_2018________________141-063_____________________Intervet,_Inc.,_2_Giralda___NUFLOR_(florfenicol),_______Cattle______________________Supplemental_approval_to____FOI_Summary.________________ |
| ________________________________________________________Farms,_Madison,_NJ_07940____Injectable_Solution_____________________________________provide_human_food_safety_______________________________ |
| ____________________________________________________________________________________________________________________________________________information_for_the_use_of______________________________ |
| ____________________________________________________________________________________________________________________________________________the_inactive_ingredient_________________________________ |
| ____________________________________________________________________________________________________________________________________________n-methyl-2-pyrrolidone__________________________________ |
| ____________________________________________________________________________________________________________________________________________(NMP)___________________________________________________ |
| May_31,_2018________________141-495_____________________Elanco_US_Inc.,_2500________INTEPRITY_(avilamycin)_and__Chickens____________________Original_approval_for_the___FOI_Summary.________________ |
| ________________________________________________________Innovation_Way,_Greenfield,_BIO-COX_(salinomycin____________________________________prevention_of_mortality_________________________________ |
| ________________________________________________________IN_46140____________________sodium)_Type_C_medicated________________________________caused_by_necrotic______________________________________ |
| ____________________________________________________________________________________feeds___________________________________________________enteritis_and_for_the___________________________________ |
| ____________________________________________________________________________________________________________________________________________prevention_of_coccidiosis_______________________________ |
| ____________________________________________________________________________________________________________________________________________in_broiler_chickens_____________________________________ |
| June_6,_2018________________141-342_____________________Jurox_Pty._Ltd.,_85_________ALFAXAN_(alfaxalone),_______Dogs_and_cats_______________Supplemental_approval_______FOI_Summary.________________ |
| ________________________________________________________Gardiner_Rd.,_Rutherford,___Injectable_Solution_____________________________________providing_for_addition_of_______________________________ |
| ________________________________________________________NSW_2320,_Australia_________________________________________________________________preservatives_and_use_of_a______________________________ |
| ____________________________________________________________________________________________________________________________________________multidose_vial__________________________________________ |
| June_14,_2018_______________098-379_____________________Merial,_Inc.,_3239__________CYSTORELIN_(gonadorelin),___Cattle______________________Supplemental_approval_for___FOI_Summary,_EA/FONSI._fn1__ |
| ________________________________________________________Satellite_Blvd.,_Bldg._500,_Injectable_Solution_____________________________________use_with_cloprostenol___________________________________ |
| ________________________________________________________Duluth,_GA_30096-4640_______________________________________________________________sodium_to_synchronize___________________________________ |
| ____________________________________________________________________________________________________________________________________________estrous_cycles_to_allow_for_____________________________ |
| ____________________________________________________________________________________________________________________________________________fixed-time_artificial___________________________________ |
| ____________________________________________________________________________________________________________________________________________insemination_(FTAI)_in__________________________________ |
| ____________________________________________________________________________________________________________________________________________lactating_dairy_cows_and________________________________ |
| ____________________________________________________________________________________________________________________________________________beef_cows_______________________________________________ |
| fn1__The_Agency_has_carefully_considered_an_environmental_assessment_(EA)_of_the_potential_environmental_impact_of_this_action_and_has_made_a_finding_of_no_significant_impact_(FONSI). |
II. Technical Amendments
With the approval of NADA 141-481, Kindred Biosciences, Inc. is now the sponsor of an approved application. Accordingly, we are amending...