Department of Health and Human Services June 26, 2024 – Federal Register Recent Federal Regulation Documents

Office of the Director; Notice of Charter Renewal
Document Number: 2024-14028
Type: Notice
Date: 2024-06-26
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting
Document Number: 2024-14027
Type: Notice
Date: 2024-06-26
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Amended Notice of Meeting
Document Number: 2024-14026
Type: Notice
Date: 2024-06-26
Agency: Department of Health and Human Services, National Institutes of Health
Unaccompanied Children Program Foundational Rule; Correction
Document Number: 2024-13560
Type: Rule
Date: 2024-06-26
Agency: Department of Health and Human Services, Administration for Children and Families
The ORR is correcting a final rule that appeared in the Federal Register on April 30, 2024. The final rule adopted and replaced regulations relating to key aspects of the placement, care, and services provided to unaccompanied children referred to the ORR, pursuant to ORR's responsibilities for coordinating and implementing the care and placement of unaccompanied children who are in Federal custody by reason of their immigration status under the Homeland Security Act of 2002 (HSA) and the William Wilberforce Trafficking Victims Protection Reauthorization Act of 2008 (TVPRA). The final rule established a foundation for the Unaccompanied Children Bureau Program (UC Bureau Program) that is consistent with ORR's statutory duties, for the benefit of unaccompanied children and to enhance public transparency as to the policies governing the operation of the UC Bureau.
Food and Drug Administration Information Technology Strategy and Customer Experience Strategy; Request for Comments
Document Number: 2024-13941
Type: Notice
Date: 2024-06-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is requesting comments on its "Information Technology (IT) Strategy" and "Customer Experience (CX) Strategy." In accordance with the Agency's User Fee Program commitments and Omnibus Bill requirements, FDA must annually update and publish its IT Strategy by September 30. The initial strategy, released in September 2023, outlines the future direction of FDA's data and technology capabilities. A key objective of FDA's IT Strategy is to modernize enterprise services and capabilities to improve customer experience. The FDA CX Strategy was created to guide this effort. This comprehensive enterprise plan introduces the Agency's CX framework and considers the perspective of interested parties such as the public, employees, and industry.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Voluntary Total Product Life Cycle Advisory Program Pilot
Document Number: 2024-13961
Type: Notice
Date: 2024-06-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Effectiveness of Anthelmintics: Specific Recommendations for Products Proposed for the Prevention of Heartworm Disease in Dogs; Guidance for Industry; Availability
Document Number: 2024-13922
Type: Notice
Date: 2024-06-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance for industry (GFI) #276 entitled "Effectiveness of Anthelmintics: Specific Recommendations for Products Proposed for the Prevention of Heartworm Disease in Dogs." The guidance provides recommendations for the effectiveness evaluation of drugs indicated for the prevention of heartworm disease caused by Dirofilaria immitis in dogs. These recommendations should be read in conjunction with related Agency Veterinary International Conference on Harmonization (VICH) guidance documents and are intended to provide additional detail to elements of study design and interpretation under the recommendations laid out in the VICH guidances.
Priority Zoonotic Animal Drug Designation and Review Process; Guidance for Industry; Availability
Document Number: 2024-13921
Type: Notice
Date: 2024-06-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry #283 entitled "Priority Zoonotic Animal Drug Designation and Review Process." This guidance is intended to assist sponsors pursuing Priority Zoonotic Animal Drug (PZAD) designation for a new animal drug. This guidance is intended to provide the eligibility criteria for PZAD designation, the process for requesting PZAD designation, and enhancements in the FDA review process for PZADs.
Agency Information Collection Request (ICR). 30-Day Public Comment Request
Document Number: 2024-13944
Type: Notice
Date: 2024-06-26
Agency: Department of Health and Human Services
In compliance with the requirements 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.
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