Department of Health and Human Services March 1, 2022 – Federal Register Recent Federal Regulation Documents

This notice announces the request for nominations for membership on the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC). Among other duties, the MEDCAC provides advice and guidance to the Secretary of the Department of Health and Human Services (the Secretary) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) concerning the adequacy of scientific evidence available to CMS in making coverage determinations under the Medicare program. The MEDCAC's fundamental purpose is to support the principles of an evidence-based determination process for Medicare's coverage policies. MEDCAC panels provide advice to CMS on the strength of the evidence available for specific medical treatments and technologies through a public, participatory, and accountable process.

The Centers for Disease Control and Prevention (CDC), 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 a proposed information collection project titled, Annual Reporting of the Rape Prevention and Education (RPE) Program. The RPE Program is the principal federally funded program focused on sexual violence (SV) prevention. This data collection allows CDC to collect information about the implementation and outcomes of CE19-1902 cooperative agreement.

The Centers for Disease Control and Prevention (CDC), in the Department of Health and Human Services (HHS), as part of its continuing effort to reduce public burden, invites the general public and other federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Preferences for Longer- Acting Preexposure Prophylaxis (LA-PrEP) Methods Among Persons in U.S. Populations at Highest Need: A Discrete Choice Experiment. The proposed project is designed to understand preferences for LA-PrEP products for HIV prevention among potential users and providers.

The Department of Health and Human Services (HHS) notifies federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITFs) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine or Oral Fluid (Mandatory Guidelines).

The Administration for Children and Families (ACF) is requesting a 3-year extension of the form ACF-118A: Child Care and Development Fund Plan for Tribes (OMB #0970-0198, expiration 06/30/ 2022) for FFY 2023-2025. There are minor changes requested to the form to improve formatting and clarify and streamline questions.

The Food and Drug Administration (FDA, Agency, or we) is classifying the screw sleeve bone fixation device into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the screw sleeve bone fixation device's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.