Department of Health and Human Services May 31, 2023 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA, the Agency, or we) is proposing to amend its human prescription drug product labeling regulations for Medication Guides (FDA-approved written prescription drug product information distributed to patients). This action, if finalized, will require applicants to create a new type of Medication Guide, referred to as Patient Medication Information (PMI), for prescription drug products, including biological products, used, dispensed, or administered on an outpatient basis and for blood and blood components transfused in an outpatient setting. PMI would be a one-page document with standardized format and content that would be submitted to FDA for approval. This proposed rule is intended to improve public health by providing patients with clear, concise, accessible, and useful written prescription drug product information delivered in a consistent and easily understood format to help patients use their prescription drug products safely and effectively.

This notice is to inform the public the Substance Abuse and Mental Health Services Administration (SAMHSA) is supporting a supplement (in scope of the parent award) for the grant recipient funded in FY 2020 under the Homeless and Housing Resource Center (HHRC) Notice of Funding Opportunity (NOFO) SM-20-009. The recipient may receive up to $498,500 in supplemental funds. The recipient has a project end date of August 30, 2024. The supplemental funding will be used to address substance use and/or mental disorders associated with service access and delivery and systems needs related to unsheltered and rural homelessness.

The Administration for Children and Families' (ACF) Office of Refugee Resettlement (ORR) plans to submit a generic information collection (GenIC) request under the following umbrella generic: Generic Clearance for Financial Reports used for ACF Mandatory Grant Programs (0970-0510). This request is to include instructions for ORR Refugee Cash and Medical Assistance (CMA) grant recipients to provide supplemental financial information when submitting the already required ORR-2 Financial Report, which is approved under Office of Management and Budget (OMB) number 0970-0407.

The Office of Refugee Resettlement (ORR), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is inviting public comments on the proposed collection. The request consists of several forms that allow the ORR Unaccompanied Children (UC) Program to enhance monitoring efforts at care provider facilities that are not licensed by the State, as well as continue standard monitoring activities that ensure its care provider facilities are in compliance with Federal and State laws and regulations, licensing and accreditation standards, ORR policies and procedures, and child welfare standards. This notice is specific to forms that were recently approved through emergency approval for 180 days and additional proposed forms.