Department of Health and Human Services February 13, 2024 – Federal Register Recent Federal Regulation Documents
Results 1 - 16 of 16
Update to the Bright Futures Periodicity Schedule as Part of the HRSA-Supported Preventive Services Guidelines for Infants, Children, and Adolescents; Correction
HRSA published documents in the Federal Register of October 24, 2023, and January 5, 2024, concerning updates to the Bright Futures Periodicity Schedule as part of the HRSA-supported preventive services guidelines for infants, children, and adolescents. These documents contained minor errors related to updates to two footnotes, including an error in the text of footnote 15 and an error in the description of footnote 21. These minor corrections align with information provided to the public on the Bright Futures web page and referenced by HRSA in the October 24, 2023, Federal Register notice that sought public comment on the proposed updates to the Bright Futures Periodicity Schedule. These corrections do not change the clinical recommendations in the Bright Futures Periodicity Schedule or the associated requirement for certain group health plans and health insurance issuers to provide coverage without cost-sharing under section 2713 of the Public Health Service Act.
Submission for Office of Management and Budget (OMB) Review; Social Services Block Grant Post-Expenditure Report, Pre-Expenditure Report, and Intended Use Plan (OMB #0970-0234)
The Administration for Children and Families' (ACF) Office of Community Services (OCS) is requesting from OMB a three-year extension of the Social Services Block Grant (SSBG) Post-Expenditure Report, Pre- Expenditure Report, and Intended Use Plan (OMB #0970-0234). OCS is proposing to make minor editorial modifications to some column titles in the Pre- and Post-Expenditure Reports, for clarification.
Use of Data Monitoring Committees in Clinical Trials; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled ``Use of Data Monitoring Committees in Clinical Trials.'' This guidance is intended to assist sponsors of clinical trials in determining when a data monitoring committee (DMC) (also known as a data and safety monitoring board (DSMB), a data and safety monitoring committee (DSMC), or an independent data monitoring committee (IDMC)) would be useful for trial monitoring and what procedures and practices should be considered to guide their operation. When finalized, this guidance will supersede the final guidance for clinical trial sponsors entitled ``Establishment and Operation of Clinical Trial Data Monitoring Committees,'' issued in March 2006. This draft guidance is not final nor is it in effect at this time.
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.
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