Department of Health and Human Services February 15, 2024 – Federal Register Recent Federal Regulation Documents
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Medicare Program; Strengthening Oversight of Accrediting Organizations (AOs) and Preventing AO Conflict of Interest, and Related Provisions
This proposed rule would set forth a number of provisions to strengthen the oversight of accrediting organizations (AOs) by addressing conflicts of interest, establishing consistent standards, processes and definitions, and updating the validation and performance standards systems. Additionally, this proposed rule would revise the psychiatric hospital survey process, add a limitation on terminated deemed providers and suppliers when reentering the program, and provides technical corrections for End-Stage Renal Disease facilities and Kidney Transplant Programs. This proposed rule also solicits comments from stakeholders and AOs to refine and revise the AO oversight standards and processes. In addition, this proposed rule includes a request for information on the timeframes and expectations for the submission of AO applications.
Statement of Organization, Functions, and Delegations of Authority
The Food and Drug Administration's (FDA), Office of the Commissioner (OC), Office of Digital Transformation (ODT) has modified their organizational structure. The new organizational structure was approved by the Secretary of Health and Human Services on December 21, 2023.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; DATA 2000 Waiver Training Payment Program Application for Payment, OMB No. 0906-0061
In compliance with the Paperwork Reduction Act of 1995, HRSA submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. OMB may act on HRSA's ICR only after the 30-day comment period for this notice has closed.
Submission for Office of Management and Budget Review; Community-Based Child Abuse Prevention Program (Office of Management and Budget #: 0970-0155)
The Children's Bureau, Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is requesting a three-year extension of the Program Instruction (PI) for the Community-Based Child Abuse Prevention (CBCAP) program (Office of Management and Budget (OMB) #: 0970-0155, expiration June 30, 2024), which outlines information collection requirements pursuant to receiving a grant award. There are no changes requested to the information collection process.
Notice of Meeting for the Interdepartmental Serious Mental Illness Coordinating Committee (ISMICC)
The Secretary of Health and Human Services announces a meeting of the Interdepartmental Serious Mental Illness Coordinating Committee (ISMICC). The meeting will provide information on federal efforts related to serious mental illness (SMI) and serious emotional disturbance (SED); the Olmstead Decision: 25 Years of History in the Making; SMI Advisor: A Modern Approach to Technical Assistance that Makes an Impact; and Report Outs from Focus Area 1Data and Evaluation; Focus Area 2 Access and Engagement; Focus Area 3Treatment and Recovery; Focus Area 4Criminal Justice and Focus Area 5Finance.
Notice for Public Comment on Administration for Native Americans' Program Policies and Procedures
Pursuant to section 814 of the Native American Programs Act of 1974 (NAPA), as amended, the Administration for Native Americans (ANA) is required to provide members of the public an opportunity to comment on proposed changes in interpretive rules and general statements of policy and to give notice of the proposed changes no less than 30 days before such changes become effective. In accordance with notice requirements of NAPA, ANA herein describes proposed interpretive rules and general statements of policy that relate to ANA's Notices of Funding Opportunities (NOFOs) in fiscal year (FY) 2024. Changes to FY NOFOs will be based on the previously published programs: Environmental Regulatory Enhancement (ERE), HHS-2021-ACF-ANA-NR-1907; Native American Language Preservation and Maintenance-Esther Martinez Immersion (EMI), HHS-2021-ACF-ANA-NB-1958; Native American Language Preservation and Maintenance (P&M), HHS-2021-ACF-ANA-NL-1924; Social and Economic Development Strategies (SEDS), HHS-2021-ACF-ANA-NA-1906; Social and Economic Development Strategies-Alaska (SEDS-AK), HHS-2021-ACF-ANA-NK- 1902.
Meeting of the National Advisory Council for Healthcare Research and Quality
This notice announces a meeting of the National Advisory Council for Healthcare Research and Quality.
Charging for Investigational Drugs Under an Investigational New Drug Application: Questions and Answers; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Charging for Investigational Drugs Under an IND: Questions and Answers.'' This guidance addresses frequently asked questions related to the implementation of FDA's regulation on charging for investigational drugs under an investigational new drug application (IND) for the purpose of either clinical trials or expanded access for treatment use. This guidance finalizes the revised draft guidance of the same title issued on August 23, 2022, and replaces the final guidance issued on June 3, 2016.
Request for Information (RFI) To Inform Development of the FY 2026-2030 NIH Strategic Plan for HIV and HIV-Related Research
Through this Request for Information (RFI), the Office of AIDS Research (OAR) in the Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI), National Institutes of Health (NIH), invites feedback from researchers, health care professionals, advocates and health advocacy organizations, scientific or professional organizations, federal/state/local government agencies, community, and other interested constituents on the development of the fiscal year (FY) 2026-2030 NIH Strategic Plan for HIV and HIV-Related Research (the Plan). The Plan (https://www.oar.nih.gov/sites/default/files/ NIH_StrategicPlan_FY2021-2025.pdf) guides the NIH investment, building on scientific progress and opportunities for advancing HIV research toward an end to the pandemic.
Government-Owned Inventions; Availability for Licensing
The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Government-Owned Inventions; Availability for Licensing
The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
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