Determination of Regulatory Review Period for Purposes of Patent Extension; Smallpox and Monkeypox Vaccine, Live

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The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for Smallpox and Monkeypox Vaccine, Live and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.