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

概要

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed revision of two forms for 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 proposed revision of two forms from ``MedWatch: The FDA Medical Products Reporting Program'' (MedWatch). These forms, Form FDA 3500 (voluntary) and Form FDA 3500A (mandatory), will be used to report to the agency on adverse events and product problems that occur with all medical products regulated by FDA. DATES: Submit written comments on the collection of information by January 11, 1999. ADDRESSES: Submit written requests for single copies of the revised MedWatch reporting forms, Form FDA 3500 (voluntary) and Form FDA 3500A (mandatory), and a summary of the proposed revisions to the forms, by e-mail to ``[email protected]'', by fax to 301-827-7241, or by mail to ``MedWatch: The FDA Medical Product Reporting Program,'' Food and Dr