Agency Emergency Processing Under Office of Management and Budget Review; Guidance for Industry: Animal Generic Drug User Fees and Fee Waivers and Reductions

摘要

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for emergency processing under the Paperwork Reduction Act of 1995 (the PRA). The proposed collection of information concerns the burden hours required to implement the new statutory requirements for the user fees and fee waivers reductions provisions of the Animal Generic Drug User Fee Act of 2008 (AGDUFA) (Federal Food, Drug, and Cosmetic Act (the act)).