Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans

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The Food and Drug Administration (FDA) is announcing that a collection of information entitled "Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans" has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.