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- Public Inspection
This interim final rule with request for comments (IFC) discusses CMS's implementation of section 3713 of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), which established Medicare Part B coverage and payment for Coronavirus Disease 2019 (COVID-19) vaccine and its administration. This IFC implements requirements in the CARES...
Microbiology Devices; Reclassification of Cytomegalovirus Deoxyribonucleic Acid Quantitative Assay Devices Intended for Transplant Patient Management, To Be Renamed Quantitative Cytomegalovirus Nucleic Acid Tests for Transplant Patient Management
The Food and Drug Administration (FDA or the Agency) is proposing to reclassify cytomegalovirus (CMV) deoxyribonucleic acid (DNA) quantitative assay devices intended for transplant patient management, a postamendments class III device (product code PAB) into class II (general controls and special controls), subject to premarket notification. FDA...
The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to remove the specified test for the presence of Mycoplasma for live virus vaccines and inactivated virus vaccines produced from in vitro living cell cultures. The rule is being finalized because the existing test for Mycoplasma is overly restrictive in that it...
The United States Patent and Trademark Office (Office or USPTO) sets or adjusts patent fees as authorized by the Leahy-Smith America Invents Act (Act or AIA), as amended by the Study of Underrepresented Classes Chasing Engineering and Science Success Act of 2018 (SUCCESS Act). The USPTO is a business-like operation where the demand for patent...
The United States Patent and Trademark Office (USPTO or Office) proposes to amend the Rules of Practice in Patent Cases and the rules regarding Representation of Others before the United States Patent and Trademark Office. This rulemaking proposes to align the USPTO Rules of Professional Conduct more closely with the ABA Model Rules of...
Patent Term Adjustment Reductions in View of the Federal Circuit Decision in Supernus Pharm., Inc. v. Iancu.
The United States Patent and Trademark Office (USPTO or Office) is revising the rules of practice pertaining to patent term adjustment in view of the decision by the U.S. Court of Appeals for the Federal Circuit (Federal Circuit) in Supernus Pharm., Inc. v. Iancu (Supernus). The Federal Circuit in Supernus held that a reduction of patent term...