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

The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) PRGLAC Implementation Working Group of Council is charged with monitoring and reporting on implementation of the recommendations from the PRGLAC. This includes monitoring and reporting on implementation, updating regulations, and guidance, as applicable, regarding the inclusion of pregnant women and lactating women in clinical trials.

The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Stillbirth Working Group of Council is charged with identifying current knowledge on stillbirth and prevention, areas of improvement for data collection, current resources for families impacted by stillbirth, and next steps to gather data and lower the rate of stillbirth in the United States.

The Food and Drug Administration (FDA, the Agency, or we) is proposing to amend its regulations to make explicit that in vitro diagnostic products (IVDs) are devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act) including when the manufacturer of the IVD is a laboratory. In conjunction with this amendment, FDA is proposing a policy under which FDA intends to phase out its general enforcement discretion approach for laboratory developed tests (LDTs) so that IVDs manufactured by a laboratory would generally fall under the same enforcement approach as other IVDs. FDA is proposing this phaseout to better protect the public health by helping to assure the safety and effectiveness of LDTs. If finalized, this phaseout may also foster the manufacturing of innovative IVDs for which FDA has determined there is a reasonable assurance of safety and effectiveness.

The Department of Health and Human Services, National Institutes of Health (NIH) published a Notice in the Federal Register on August 14, 2023. This document extends the date to submit Letters of Interest (LOIs) to the National Cancer Institute (NCI), NIH.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Human Prescription Drug and Biological ProductsLabeling for Dosing Based on Weight or Body Surface Area for Ready-to-Use Containers`Dose Banding.' '' The guidance is intended to assist applicants in incorporating dose banding information, based on dosing information of a previously approved drug product that is based on weight or body surface area (BSA), into the proposed labeling of injectable drug products that are the subject of certain marketing applications submitted to FDA. This guidance finalizes the draft guidance of the same title issued on July 21, 2022.

The Administration for Children and Families (ACF) Office of Planning, Research, and Evaluation (OPRE) at the U.S. Department of Health and Human Services (HHS) is proposing to collect information to examine a toolkit of new measures designed to assess and strengthen the quality of child care, the Home-Based Child Care Toolkit for Nurturing School-Age Children (HBCC-NSAC Toolkit). This study aims to build evidence about the English version of the HBCC-NSAC Toolkit for use by/ with providers caring for children in a residential setting (i.e., home-based child care [HBCC]).