Zdrowie i gospodarka · 24.10.1997
Agency Information Collection Activities: Proposed Collection; Comment Request
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on a proposed revision of the form for the 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 a revised, harmonized transmittal form, ``Transmittal of Advertisements and Promotional Labeling for Drugs and Biologics for Human Use'' (Form FDA 2253). This revised and harmonized form will be used for the submission of advertisements and promotional labeling for prescription drugs, antibiotics, and biological products that are regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER).