Zdrowie i gospodarka · 20.10.2009
Agency Information Collection Activities; Proposed Collection; Comment Request; Recommendations for Clinical Laboratory Improvement Amendments of 1988 Waiver Applications
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, including each proposed extension, of an existing collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on collections of information associated with the guidance issued January 30, 2008, and titled "Recommendations: Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices".