Department of Health and Human Services September 28, 2022 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance document related to the Coronavirus Disease 2019 (COVID-19) public health emergency (PHE) entitled ``Policy for Coronavirus Disease2019 Tests During the Public Health Emergency (Revised).'' FDA is issuing this guidance to provide FDA's revised enforcement policies and review priorities regarding certain novel coronavirus (COVID-19) tests for the duration of the public health emergency. Rapid detection of COVID-19 cases in the United States requires wide availability of testing to control the spread of this highly contagious infection. This document supersedes ``Policy for Coronavirus Disease2019 Tests During the Public Health Emergency (Revised)'' issued November 15, 2021. The guidance identified in this notice addresses issues related to the COVID-19 PHE and has been issued in accordance with the expedited process FDA announced in the Federal Register of March 25, 2020, for making available to the public COVID-19-related guidances. This guidance has been implemented without prior comment, but it remains subject to comment in accordance with the Agency's good guidance practices.

The Office of Planning, Research, and Evaluation (OPRE) within the Administration for Children and Families (ACF) is proposing a new information collection for the Child Welfare Study to Enhance Equity with Data (CW-SEED). The project aims to understand how and to what extent data are used to explore equity in service delivery and child and family outcomes, to identify barriers or problematic data practices, and to explore efforts by child welfare agencies and their partners to use data to reduce barriers across the continuum of child welfare services.

The Food and Drug Administration (FDA or Agency) is proposing to amend its regulations to modernize, simplify, and enhance the current system for oversight of FDA-regulated human subject research. This proposed rule, if finalized, would harmonize certain sections of FDA's regulations on human subject protection and institutional review boards (IRBs), to the extent practicable and consistent with other statutory provisions, with the revised Federal Policy for the Protection of Human Subjects (the revised Common Rule), in accordance with the 21st Century Cures Act (Cures Act). We believe the proposed changes, if finalized, will reduce regulatory burden on IRBs, sponsors, and investigators. In addition, we propose related changes to the investigational device exemption (IDE) regulations to clarify and update the requirements for the submission of progress reports.

The Food and Drug Administration's (FDA), Center for Biologics Evaluation and Research (CBER), Office of Tissues and Advanced Therapies (OTAT) has modified its organizational structures.

The Administration for Children and Families (ACF), of the U.S. Department of Health and Human Services (HHS), is proposing to extend data collection activity for BEES. We are not proposing any changes to the currently approved materials. Data collected is being used to estimate the effects of the participating programs on employment, earnings, and other key outcomes for the purpose of assessing the effectiveness of the program.

In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.

The Food and Drug Administration (FDA or Agency) is requesting that any small business tobacco manufacturing industry organizations interested in participating in the selection of a nonvoting industry representative to serve on the Tobacco Products Scientific Advisory Committee for the Center for Tobacco Products notify FDA in writing. FDA is also requesting nominations for nonvoting industry representatives to be included in a pool of individuals to represent the interests of the small business tobacco manufacturing industry on the Tobacco Products Scientific Advisory Committee. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. This position may be filled on a rotating, sequential basis by representatives of different small business tobacco manufacturers based on areas of expertise relevant to the topics being considered by the Advisory Committee. Nominations will be accepted for current vacancies effective with this notice.