Agency Emergency Processing Under Office of Management and Budget Review; Orphan Drug Products; Common European Medicines Evaluation Agency/Food and Drug Administration Application Form for Orphan Medicinal Product Designation

Streszczenie

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for emergency processing under the Paperwork Reduction Act of 1995 (the PRA). The proposed collection of information is an amendment to OMB control number 0910-0167 and concerns the joint adoption by FDA and the European Medicines Evaluation Agency (EMEA) of the Common EMEA/FDA Application Form for Orphan Medicinal Product Designation (form FDA 3671).