Department of Health and Human Services December 26, 2018 – Federal Register Recent Federal Regulation Documents

The Administration for Community Living is announcing that the proposed collection of information listed above has been submitted to the Office of Management and Budget (OMB) for review and clearance as required under the Paperwork Reduction Act of 1995. This 30-Day notice collects comments on the information collection requirements related to Independent Living Services Program Performance Report (Proposed Extension with Changes of a Currently Approved Collection (ICR Rev)).

Findings of research misconduct have been made against Uthra Rajamani, Ph.D. (Respondent), former project scientist in the Induced Pluripotent Stem Cell Core Facility, Cedars-Sinai Medical Center (CSMC). Dr. Rajamani engaged in research misconduct in research supported by National Center for Advancing Translational Science (NCATS), National Institutes of Health (NIH), grant UL1 TR000124. The administrative actions, including supervision for a period of one (1) year, were implemented beginning on November 27, 2018, and are detailed below.

The Agency for Toxic Substances and Disease Registry (ATSDR), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on ``Exposure Characterization and Measurements during Activities Conducted on Synthetic Turf Fields with Tire Crumb Rubber Infill.'' The purpose of the proposed study is to evaluate and characterize human exposure potential to select chemicals during play on synthetic turf fields with tire crumb rubber infill.

The Food and Drug Administration (FDA) is issuing a final order to reclassify the electroconvulsive therapy (ECT) device for use in treating catatonia or a severe major depressive episode (MDE) associated with major depressive disorder (MDD) or bipolar disorder (BPD) in patients age 13 years and older who are treatment-resistant or who require a rapid response due to the severity of their psychiatric or medical condition, which is a preamendments class III device, into class II (special controls). FDA is also issuing this final order to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the preamendments class III ECT devices for all other uses that are not being reclassified to class II (product code GXC).

The Food and Drug Administration (FDA or Agency) has determined the regulatory review period for ADLYXIN 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 drug product.

This proposed notice announces that CMS is considering granting approval of the Utilization Review Accreditation Commission's (URAC) renewal application for Medicare Advantage ``deeming authority'' of Health Maintenance Organizations and Preferred Provider Organizations. This new 6-year term of approval would begin on the date of publication of the final notice. This notice also announces a 30-day period for the public to submit comments on CMS' renewal of the application.