Department of Health and Human Services October 23, 2023 – Federal Register Recent Federal Regulation Documents
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Animal Generic Drug User Fee Program Rates and Payment Procedures for Fiscal Year 2024
The Food and Drug Administration (FDA or Agency) is announcing the fee rates and payment procedures for fiscal year (FY) 2024 generic new animal drug program user fees. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Animal Generic Drug User Fee Amendments of 2023 (AGDUFA IV), authorizes FDA to collect user fees for certain abbreviated applications for generic new animal drugs, for certain generic new animal drug products, for certain sponsors of such abbreviated applications for generic new animal drugs and/or investigational submissions for generic new animal drugs, and for certain submissions related to generic investigational new animal drug (JINAD) files. This notice establishes the fee rates for FY 2024.
Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2024
The Food and Drug Administration (FDA or Agency) is announcing the fee rates and payment procedures for fiscal year (FY) 2024 animal drug user fees. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Animal Drug User Fee Amendments of 2023 (ADUFA V), authorizes FDA to collect user fees for certain animal drug applications and supplemental animal drug applications, for certain animal drug products, for certain establishments where such products are made, and for certain sponsors of such animal drug applications and/or investigational animal drug submissions. This notice establishes the fee rates for FY 2024.
Proposed Data Collection Submitted for Public Comment and Recommendations
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other federal agencies to comment on a continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Promoting Adolescent Health through School-Based HIV/STD Prevention Reporting Templates. The data collection is designed to obtain detailed, specific, and consistent reporting measures to ensure that the Division of Adolescent and School Health (DASH) can determine the context, process, and effectiveness of program activities.
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