Department of Health and Human Services May 7, 2024 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "REMS Logic Model: A Framework to Link Program Design With Assessment." The guidance describes FDA's risk evaluation and mitigation strategy (REMS) logic model. The REMS logic model is a framework that FDA recommends, which provides applicants with a systematic, structured approach to the design, implementation, and evaluation of a REMS. The aim of applying the REMS logic model is to develop clear goals, objectives, and strategies that align with the intended outcomes and to help applicants of new drug applications (NDAs), biologics license applications (BLAs), and abbreviated new drug applications (ANDAs) incorporate REMS assessment planning into the design of a REMS. The principles in this guidance apply to designing a REMS, developing a REMS assessment, and modifying a REMS.

The Administration for Children and Families (ACF) proposes to extend approval of the existing overarching generic clearance for Financial Reports used for ACF Non-discretionary Grant Programs (OMB #0970-0510) as well as all information collections currently approved under the overarching generic. There are no changes to the proposed types of information collection or uses of data as described in the overarching generic. The title of the collection has been updated from ACF Mandatory Grant Programs to ACF Non-Discretionary Grant Programs. This request also includes updates to three of the collections approved under this generic (GenICs): the Child Care and Development Fund (CCDF) ACF-696 Financial Report for States and Territories, the CCDF ACF-696T Financial Report for Tribal Grantees, and the Child Support Services Program Financial Reporting Forms (OCSS-34 and OCSS-396). Finally, burden estimates for the next 3 years have been adjusted based on use to date.

The Food and Drug Administration (FDA or Agency) is withdrawing approval of 12 abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

The Food and Drug Administration's (FDA), Center for Devices and Radiological Health's (CDRH), Office of Communication and Education (OCE) has modified their organizational structure. The new organizational structure was approved by the Secretary of Health and Human Services on December 21, 2023, and it became effective on January 22, 2024.

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other federal agencies the opportunity to comment on a continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled the National Hospital Care Survey (NHCS). The goal of the project is to assess patient care in hospital-based settings and to describe patterns of health care delivery and utilization in the United States.

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other federal agencies the opportunity to comment on a proposed information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on an information collection project titled Human-Centered Design Effort on Bringing Guidelines to the Digital Age. This information collection will allow CDC to understand pain points in developing solutions that help develop and implement guidelines that leverage technology to improve patient care.

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other federal agencies the opportunity to comment on a continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Evaluation of the Division of Overdose Prevention Technical Assistance Center. This data collection allows CDC to collect information from partner organizations regarding feedback on their experiences receiving technical assistance.