Zdrowie i gospodarka · 21.10.1999
Agency Information Collection Activities; Proposed Collection; Comment Request; Application to Market a New Drug, Biologic, or an Antibiotic Drug for Human UseForm FDA 356h
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 the application form, Application to Market a New Drug, Biologic, or an Antibiotic Drug for Human Use, Form FDA 356h, and a related regulation. This form applies to a wide range of products for human use that are regulated by both the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER) including drugs and biologics.