Department of Health and Human Services August 27, 2020 – Federal Register Recent Federal Regulation Documents

In the August 4, 2020 issue of the Federal Register, we published a final rule entitled ``FY 2021 Inpatient Psychiatric Facilities Prospective Payment System (IPF PPS) and Special Requirements for Psychiatric Hospitals for Fiscal Year Beginning October 1, 2020 (FY 2021)''. The August 4, 2020 final rule updates the prospective payment rates, the outlier threshold, and the wage index for Medicare inpatient hospital services provided by Inpatient Psychiatric Facilities (IPF), which include psychiatric hospitals and excluded psychiatric units of an Inpatient Prospective Payment System (IPPS) hospital or critical access hospital. In addition, we adopted more recent Office of Management and Budget (OMB) statistical area delineations, and applied a 2-year transition for all providers negatively impacted by wage index changes. This correction document corrects the statement of economic significance in the August 4, 2020 final rule.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Evaluating Cancer Drugs in Patients with Central Nervous System Metastases.'' This draft guidance document provides recommendations regarding the design of clinical trials of drugs and biological products regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) that are intended to support product labeling describing the antitumor activity in patients with central nervous system (CNS) metastases from solid tumors originating outside the CNS. The draft guidance includes study design recommendations regarding the patient population, available therapy, prior therapies, assessment of CNS disease, study endpoints, and leptomeningeal disease.

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 the Institute for Safe Medication Practices (ISMP), PSO number P0009, of its status as a PSO, and has delisted the PSO accordingly.

HRSA is seeking additional nominations of qualified tribal officials as candidates for consideration for appointment as voluntary delegate members of the HRSA Tribal Advisory Council (TAC), which is being established. Specifically, HRSA requests submissions of nominations of qualified tribal officials from the Indian Health Service (IHS) geographic areas of: Alaska; Albuquerque; Billings; Navajo; Phoenix; and Tucson. Nominations for membership must be received on or before September 30, 2020. This will allow tribes and tribal serving organizations from the IHS geographic areas noted above, the additional time needed to identify qualified tribal officials as candidates and submit comprehensive nomination packages.

In accordance with the requirements of the Privacy Act of 1974, as amended, the Department of Health and Human Services (HHS) is establishing a new system of records to be maintained by the Centers for Disease Control and Prevention, 09-20-0180, ``Electronic Import Permit Program Portal (eIPP Portal).'' The system of records will be used by CDC to monitor the importation of infectious biological agents, infectious substances, and vectors of human disease.