Agency Information Collection Activities; Proposed Collection; MedWatch: The FDA Medical Products Reporting Program; Comment Request

Resumo

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 60 days for public comment in response to the notice. This notice solicits comments on the "MedWatch: The FDA Medical Products Reporting Program" forms (Form FDA 3500--voluntary version and Form FDA 3500A--mandatory version). These forms are currently used to report to the agency about adverse events, product problems, and medication errors that occur with FDA regulated products, including drugs, biologicals, medical devices, and special nutritional products.