Zdrowie i gospodarka · 01/10/1996

Agency Information Collection Activities: Proposed Collection; Comment Request

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, Federal agencies are required to publish a 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 a new harmonized application form, Application to Market a New Drug, Biologic, or an Antibiotic Drug for Human Use, Form FDA 356h. This form will apply to a wide range of products for human use that are regulated by both the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER), including drugs, biologics, and antibiotics. The form will replace a number of different application forms that are now used for these products.