Zdrowie i gospodarka · 9.03.2009
Agency Information Collection Activities; Proposed Collection; Comment Request; Evaluation of Potential Data Sources for the Sentinel Initiative
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 proposed information collection through a survey designed to identify potential data sources and/or data environments that could participate in the Sentinel Initiative to create a national, electronic distributed system, strengthening FDA's ability to monitor the postmarket performance of a medical product.