Agency Information Collection Activities; Announcement of OMB Approval; New Drug and Biological Drug Products; Evidence Needed to Demonstrate Efficacy of New Drugs for Use Against Lethal or Permanently Disabling Toxic Substances When Efficacy Studies in Humans Ethically Cannot Be Conducted

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The Food and Drug Administration (FDA) is announcing that a collection of information entitled "New Drug and Biological Drug Products; Evidence Needed to Demonstrate Efficacy of New Drugs for Use Against lethal or Permanently Disabling Toxic Substances When Efficacy Studies in Humans Ethically Cannot Be Conducted" has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.