Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Orphan Drugs; Common European Medicines Agency/Food and Drug Administration Application Form for Orphan Medicinal Product Designation (Food and Drug Administration Form 3671)

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The Food and Drug Administration (FDA) is announcing that a collection of information entitled "Orphan Drugs; Common European Medicines Agency/Food and Drug Administration Application Form for Orphan Medicinal Product Designation (FDA Form 3671)" has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.