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Zdrowie i gospodarka · 30.04.2002

Agency Information Collection Activities; Proposed Collection; Comment Request; Generic FDA Rapid Response Surveys

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 rapid response surveys to obtain data on safety information to support quick-turnaround decisionmaking about potential safety problems or risk management solutions from health care professionals, hospitals and other user-facilities (e.g., nursing homes, etc.), consumers, manufacturers of biologics, drugs and medical devices, distributors, and importers when FDA must quickly determine whether or not a problem with a biologic, drug, or medical device impacts the public health.

Source: Federal Register — Food and Drug AdministrationOpen original release →