Department of Health and Human Services September 17, 2024 – Federal Register Recent Federal Regulation Documents

Chemistry, Manufacturing, and Controls Technical Section Filing Strategies; Draft Guidance for Industry; Availability
Document Number: 2024-20924
Type: Notice
Date: 2024-09-17
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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry (GFI) #227 entitled "Chemistry, Manufacturing, and Controls (CMC) Technical Section Filing Strategies." This draft guidance provides recommendations to sponsors submitting CMC data submissions to new animal drug applications. This guidance describes the options for soliciting early input from the Center for Veterinary Medicine (CVM) and the process for submission of components of the CMC technical section.
Public Health Service Policies on Research Misconduct
Document Number: 2024-20814
Type: Rule
Date: 2024-09-17
Agency: Department of Health and Human Services
This final rule revises the regulations governing Public Health Service Policies on Research Misconduct. The final rule reflects both substantive and non-substantive revisions in response to public comments and to improve clarity. The purpose of the final rule is to implement policy changes and respond to technological changes that occurred over the past several years applicable to research misconduct.
Medical Devices; Immunology and Microbiology Devices; Classification of the Quantitative Viral Nucleic Acid Test for Transplant Patient Management
Document Number: 2024-21086
Type: Rule
Date: 2024-09-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, Agency, or we) is classifying the quantitative viral nucleic acid test for transplant patient management into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the quantitative viral nucleic acid test for transplant patient management's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2024-21063
Type: Notice
Date: 2024-09-17
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Proposed Collection; 30-Day Comment Request; Stakeholder Measures and Advocate Forms at the National Cancer Institute (NCI)
Document Number: 2024-21059
Type: Notice
Date: 2024-09-17
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide the opportunity for public comment on proposed data collection projects, the National Institutes of Health, National Cancer Institute (NCI) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2024-21055
Type: Notice
Date: 2024-09-17
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Notice of Closed Meeting
Document Number: 2024-21103
Type: Notice
Date: 2024-09-17
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Digital Health Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Total Product Lifecycle Considerations for Generative Artificial Intelligence-Enabled Medical Devices
Document Number: 2024-21074
Type: Notice
Date: 2024-09-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Digital Health Advisory Committee (the Committee). The general function of the Committee is to provide advice and recommendations to FDA on regulatory issues. The Committee will discuss total product lifecycle considerations for Generative Artificial Intelligence (AI)-enabled devices. The meeting will be open to the public. FDA is establishing a docket for public comment on this topic.
Findings of Research Misconduct
Document Number: 2024-21016
Type: Notice
Date: 2024-09-17
Agency: Department of Health and Human Services, Office of the Secretary
Findings of research misconduct have been made against Arunoday K. Bhan, Ph.D. (Respondent), who was formerly a Research Fellow, Department of Pediatrics, Boston Children's Hospital (BCH), Harvard Medical School (HMS), and a former Staff Scientist, Department of Surgery, City of Hope Medical Center (COH). Respondent engaged in research misconduct in research supported by U.S. Public Health Service (PHS) funds, specifically National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), grant T32 HL066987. The questioned research was included in two grant applications submitted for PHS funds, specifically R03 CA270990-01 and R21 CA272364-01 submitted to the National Cancer Institute (NCI), NIH. The administrative actions, including supervision for a period of four (4) years, were implemented beginning on August 21, 2024, and are detailed below.
Medicare and Medicaid Programs; Application From the Accreditation Commission for Health Care, Inc. (ACHC) for Continued Approval of Its Home Health Agency Accreditation Program
Document Number: 2024-21014
Type: Notice
Date: 2024-09-17
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed notice acknowledges the receipt of an application from the Accreditation Commission for Health Care, Inc. (ACHC) for continued recognition as a national accrediting organization for home health agencies (HHAs) that wish to participate in the Medicare or Medicaid programs. The statute requires that within 60 days of receipt of an organization's complete application, the Centers for Medicare & Medicaid Services (CMS) must publish a notice that identifies the national accrediting body making the request, describes the nature of the request, and provides at least a 30-day public comment period.
Considerations for Generating Clinical Evidence From Oncology Multiregional Clinical Development Programs; Draft Guidance for Industry; Availability
Document Number: 2024-20995
Type: Notice
Date: 2024-09-17
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 draft guidance for industry entitled "Considerations for Generating Clinical Evidence From Oncology Multiregional Clinical Development Programs." This draft guidance provides recommendations to sponsors who are planning global clinical development programs for drugs intended to treat cancer, on improving the evidence obtained from one or more multiregional clinical trials (MRCTs) intended to support a marketing application. This draft guidance expands on principles described in FDA's existing guidance documents related to this topic, by providing additional recommendations for the planning, design, conduct, and analysis of an oncology MRCT that may facilitate FDA's assessment of applicability of the data to the U.S. population with the cancer being investigated and to U.S. medical practice.
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2024-21025
Type: Notice
Date: 2024-09-17
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2024-21024
Type: Notice
Date: 2024-09-17
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2024-21023
Type: Notice
Date: 2024-09-17
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Nursing Research; Notice of Closed Meetings
Document Number: 2024-21122
Type: Notice
Date: 2024-09-17
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Deafness and Other Communication Disorders; Notice of Closed Meetings
Document Number: 2024-21120
Type: Notice
Date: 2024-09-17
Agency: Department of Health and Human Services, National Institutes of Health
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