Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; General Licensing Provisions: Biologics License Application, Changes to an Approved Application, Labeling, Revocation and Suspension, Postmarketing Studies Status Reports, and Forms FDA 356h and 2567

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The Food and Drug Administration (FDA) is announcing that a collection of information entitled "General Licensing Provisions: Biologics License Application, Changes to an Approved Application, Labeling, Revocation and Suspension, Postmarketing Studies Status Reports, and Forms FDA 356h and 2567" has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.