Agency Information Collection Activities; Proposed Collection; Comment Request; Prescription Drug Labeling Improvement and Enhancement Initiative

Streszczenie

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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection for the Prescription Drug Labeling Improvement and Enhancement Initiative (the initiative); specifically, information collection associated with the use of Government contractor-assisted labeling conversion resources and services for certain older drug and biological products (approved before June 30, 2001). The intent of the initiative is to enhance the safe and effective use of prescription drugs by facilitating optimal communication through labeling.