Department of Health and Human Services September 16, 2019 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorization (EUA) (the Authorization) issued to Siemens Healthcare Diagnostics, Inc. (Siemens), for the ADVIA Centaur Zika test. FDA revoked this Authorization on July 17, 2019, under the Federal Food, Drug, and Cosmetic Act (FD&C Act), in consideration of the premarket notification submission submitted to FDA by Siemens for the ADVIA Centaur Zika test that was determined to be substantially equivalent to a legally marketed class II predicate device on July 17, 2019. The revocation, which includes an explanation of the reasons for revocation, is reprinted in this document.

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. to achieve expeditious commercialization of results of federally-funded research and development.

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of February 5, 2019. The document announced the withdrawal of approval of 23 abbreviated new drug applications (ANDAs) from multiple applicants, effective March 7, 2019. The document erroneously included ANDA 077895 for Ursodiol Capsules USP, 300 milligrams, held by Impax Laboratories, LLC. This notice corrects that error.

This notice announces a 1-year extension of the Medicare Prior Authorization Model for Repetitive Scheduled Non-Emergent Ambulance Transport. The extension of this model is applicable to the following states and the District of Columbia: Delaware, Maryland, New Jersey, North Carolina, Pennsylvania, South Carolina, Virginia, and West Virginia.