Zdrowie i gospodarka · 23.03.2020
Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry and Food and Drug Administration Staff; Combination Products: How To Prepare a Pre-Request for Designation
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the type of information recommended for a Pre-Request for Designation (Pre-RFD) submission.