Department of Health and Human Services September 11, 2019 – Federal Register Recent Federal Regulation Documents

In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of Laboratory Animal Welfare (OLAW) in the Office of Extramural Research has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for EDWARDS PERICARDIAL AORTIC BIOPROSTHESIS (Models 11000A and 11500A) and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that medical device.

The Patient Safety and Quality Improvement Final Rule (Patient Safety Rule) authorizes AHRQ, on behalf of the Secretary of HHS, to list as a patient safety organization (PSO) an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be ``delisted'' by the Secretary if it is found to no longer meet the requirements of the Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act) and Patient Safety Rule, when a PSO chooses to voluntarily relinquish its status as a PSO for any reason, or when a PSO's listing expires. AHRQ accepted a notification of proposed voluntary relinquishment from Healthcare Quality Support, LLC (P0050); Premier Patient Safety Organization (P0054); QA STATS LLC (P0140); Securus Medica, LLC (P0053); Vascular Study Group Patient Safety Organization, LLC (P0080); and Washington State Patient Safety Organization PSO (P0060), of their PSO status and delisted the PSOs accordingly, but did not previously publish notices of their delisting in the Federal Register.