Zdrowie i gospodarka · 23.10.2008
Agency Information Collection Activities; Proposed Collection; Comment Request; Electronic Data Collection Using MedWatchPlus Portal and Rational Questionnaire
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 use of MedWatch\Plus\ Portal and Rational Questionnaire to collect electronically all adverse event, consumer complaint/product problem and medication use error data submitted to FDA.