Agency Information Collection Activities; Proposed Collection; Comment Request; Records and Reports Concerning Experience With Approved New Animal Drugs; Proposed New Data Elements for Adverse Event Reports on Revised Forms FDA 1932 and 1932a

الملخص

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 and to allow 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, specifically on new data elements to be used in revised versions of Forms FDA 1932 and 1932a. 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.