Agency Information Collection Activities; Announcement of OMB Approval; Applications for FDA Approval to Market a New Drug: Patent Submission and Listing Requirements and Application of 30-Month Stays on Approval of Abbreviated New Drug Applications Certifying That a Patent Claiming a Drug Is Invalid or Will Not Be Infringed

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The Food and Drug Administration (FDA) is announcing that a collection of information entitled "Applications for FDA Approval to Market a New Drug: Patent Submission and Listing Requirements and Application of 30-Month Stays on Approval of Abbreviated New Drug Applications Certifying That a Patent Claiming a Drug Is Invalid or Will Not Be Infringed" has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.