Department of Health and Human Services July 21, 2020 – Federal Register Recent Federal Regulation Documents

The Centers for Disease Control and Prevention (CDC), a component of the U.S. Department of Health and Human Services (HHS), announces a second modification and extension of the No Sail Order and Other Measures Related to Operations that was issued on April 15, 2020. This Order applies to cruise ships defined as commercial, non-cargo, passenger-carrying vessels with the capacity to carry 250 or more individuals (passengers and crew) and with an itinerary anticipating an overnight stay onboard or a 24-hour stay onboard for either passengers or crew, that are operating in international, interstate, or intrastate waterways, subject to the jurisdiction of the United States. This Order shall additionally apply to cruise ships operating outside of U.S. waters if the cruise ship operator intends for the ship to return to operating in international, interstate, or intrastate waterways, subject to the jurisdiction of the United States during the period that this Order is in effect.

The Food and Drug Administration (FDA, the Agency, or we) is hosting a public meeting entitled ``Independent Third-Party Assessment of IND FDA-Sponsor Communication Practices in PDUFA VI,'' and an opportunity for public comment. The meeting will include a presentation from an independent third-party contractor about its assessment of FDA- sponsor communications during the investigational new drug (IND) stage of drug/biologic development in the Prescription Drug User Fee Act (PDUFA) VI; a series of presentations by and a panel discussion with invited regulatory and industry representatives, and an open public comment period. This meeting is intended to satisfy FDA's commitment to host a public meeting about the assessment no later than March 2021.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Oncologic Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.

In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

The Centers for Medicare and Medicaid Services (CMS) is requesting that a new information collection request (ICR) related to the Medicare Current Beneficiary Survey (MCBS) (OMB clearance 0938- 0568) be processed under the emergency clearance process. Due to CMS' determination that this collection of information is needed prior to the expiration of time periods established under its regulations, an emergency clearance is requested. Once the emergency information collection request is approved, CMS plans to seek public comments during the required 60-day and 30-day notice and comment periods associated with obtaining a standard (non-emergency) OMB approval for extending the information collection request as part of the MCBS (collected under 0938-0568). The approval of this information collection package is necessary because of the urgent need to obtain timely data to assess the impact of the coronavirus pandemic on the Medicare population. Adding a COVID-19 Supplement to the MCBS data collection in October 2020 will provide critical information to CMS and the public.

The Administration for Community Living (ACL) announces the intent to award a single-source supplement to the current cooperative agreement held by The National Council on Aging for the project Piloting the Remote Delivery of Falls Prevention Programs. The purpose of this supplement is to scale-up research activities for falls prevention interventions delivered remotely/virtually.