Agency Information Collection Activities; Proposed Collection; Comment Request; Records and Reports Concerning Experience With Approved New Animal Drugs

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The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on requirements for recordkeeping and reports concerning experience with approved new animal drugs. The information contained in the reports required by this regulation enables FDA to monitor the use of new animal drugs after approval and to ensure their continued safety and efficacy.