Agency Information Collection Activities; Proposed Collection; Comment Request; Prescription Drug User Fee Cover Sheet; Form FDA 3397

Zusammenfassung

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 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 information collection requirements relating to the Prescription Drug User Fee Cover Sheet, Form FDA 3397, that must be submitted along with certain drug and biological product applications.