Department of Health and Human Services October 3, 2023 – Federal Register Recent Federal Regulation Documents
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National Advisory Child Health and Human Development Council Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC) Implementation Working Group Meeting
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.
National Advisory Child Health and Human Development Council Stillbirth Working Group Meeting
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.
Announcing a Public Meeting of the President's Council on Sports, Fitness & Nutrition
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services (HHS) is hereby giving notice that the President's Council on Sports, Fitness & Nutrition (PCSFN) will hold a meeting for the subcommittees to share their plans and progress with the full Council. The meeting will be open to the public.
Medical Devices; Laboratory Developed Tests
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.
Office of the Secretary, Interagency Pain Research Coordinating Committee Call for Committee Membership Nominations
The Department of Health and Human Services (HHS) (Department) has created the Interagency Pain Research Coordinating Committee (IPRCC) and is seeking nominations for this committee.
Request for Letters of Interest (LOI) for NCI-ComboMATCH Laboratories; Extension of Submission Period
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.
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