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2020-08-01
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Animal Generic Drug User Fee Rates and Payment Procedures for Fiscal Year 2021
Notices
D09002ee1bdb4a50f
D09002ee1bdb4a5a2
United States
Department of Health and Human Services
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org
United States Government Agency or Subagency
United States
Food and Drug Administration
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org
United States Government Agency or Subagency
The Food and Drug Administration (FDA or Agency) is announcing the fee rates and payment procedures for fiscal year (FY) 2021 generic new animal drug user fees. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Animal Generic Drug User Fee Amendments of 2018 (AGDUFA III), authorizes FDA to collect user fees for certain abbreviated applications for generic new animal drugs, for certain generic new animal drug products, and for certain sponsors of such abbreviated applications for generic new animal drugs and/or investigational submissions for generic new animal drugs. This notice establishes the fee rates for FY 2021.
85 FR 46647
https://www.govinfo.gov/app/details/FR-2020-08-03/2020-16688
2020-16688
fr03au20-46
4164-01-P
Docket No. FDA-2019-N-3523
https://www.govinfo.gov/app/details/FR-2020-08-03/2020-16688
https://www.govinfo.gov/content/pkg/FR-2020-08-03/html/2020-16688.htm
https://www.govinfo.gov/content/pkg/FR-2020-08-03/pdf/2020-16688.pdf
5 p.
46647
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85 FR 46647
Animal Generic Drug User Fee Rates and Payment Procedures for Fiscal Year 2021; Federal Register Vol. 85, Issue
NOTICE
2020-16688
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2019-N-3523
4164-01-P
2020-16688
Notice.
The Food and Drug Administration (FDA or Agency) is announcing the fee rates and payment procedures for fiscal year (FY) 2021 generic new animal drug user fees. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Animal Generic Drug User Fee Amendments of 2018 (AGDUFA III), authorizes FDA to collect user fees for certain abbreviated applications for generic new animal drugs, for certain generic new animal drug products, and for certain sponsors of such abbreviated applications for generic new animal drugs and/or investigational submissions for generic new animal drugs. This notice establishes the fee rates for FY 2021.
Lisa Kable, Center for Veterinary Medicine (HFV-10), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-6888, Lisa.Kable@fda.hhs.gov or visit FDA's website at https://www.fda.gov/ForIndustry/UserFees/ AnimalGenericDrugUserFeeActAGDUFA/default.htm. For general questions, you may also email the Center for Veterinary Medicine (CVM) at cvmagdufa@fda.hhs.gov.
Animal Generic Drug User Fee Rates and Payment Procedures for Fiscal Year 2021,
cvmagdufa@fda.hhs.gov
Lisa.Kable@fda.hhs.gov
https://userfees.fda.gov/pay
https://www.bls.gov/cpi/additional-resources/geographic-revision-2018.htm
https://www.fda.gov/ForIndustry/UserFees/AnimalGenericDrugUserFeeActAGDUFA/default.htm
https://www.fda.gov/ForIndustry/UserFees/AnimalGenericDrugUserFeeActAGDUFA/ucm137049.htm
Pay.gov
Federal Register
Vol. 85, no. 149
Office of the Federal Register, National Archives and Records Administration
2020-08-03
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Table of Contents:
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https://www.govinfo.gov/app/details/FR-2020-08-03
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https://www.govinfo.gov/app/details/FR-2020-08-03
https://www.govinfo.gov/content/pkg/FR-2020-08-03/pdf/FR-2020-08-03.pdf
https://www.govinfo.gov/content/pkg/FR-2020-08-03/xml/FR-2020-08-03.xml
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FR-2020-08-03
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