Agency Information Collection Activities; Announcement of OMB Approval; Regulations Requiring Manufacturers to Assess the Safety and Effectiveness of New Drugs and Biological Products in Pediatric Patients

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The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Regulations Requiring Manufacturers to Asses the Safety and Effectiveness of New Drugs and Biological Products in Pediatric Patients'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.