Department of Health and Human Services January 30, 2024 – Federal Register Recent Federal Regulation Documents
Results 1 - 25 of 25
Possession, Use, and Transfer of Select Agents and Toxins; Biennial Review of the List of Select Agents and Toxins
In accordance with the Public Health Service Act, the Department of Health and Human Services (HHS) Centers for Disease Control and Prevention (CDC) reviewed the HHS list of select agents and toxins with the potential to pose a severe threat to public health and safety. HHS/CDC proposes to amend the list by removing three biological agents, raising one toxin's exclusion amounts, renaming a virus, designating a current agent as a Tier 1 agent, and removing the designation of Tier 1 status from one agent. HHS/CDC also proposes to clarify language and add requirements as discussed below.
Submission for Office of Management and Budget Review; Office of Human Services Emergency Preparedness and Response Disaster Human Services Case Management Intake Assessment, Resource Referral, and Case Management Plan
The Office of Human Services Emergency Preparedness and Response (OHSEPR), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is requesting an extension for approval of the following information collection: OHSEPR Disaster Human Services Case Management Intake Assessment, Resource Referral, and Case Management Plan; OMB No.: 0970-0619. This information collection was originally approved for 6 months through an emergency approval.
Considerations for the Development of Chimeric Antigen Receptor T Cell Products; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products; Guidance for Industry.'' The guidance is intended to assist sponsors, including industry and academic sponsors, developing ex vivo- manufactured CAR T cell products. The guidance provides CAR T cell specific recommendations regarding chemistry, manufacturing, and control (CMC), pharmacology and toxicology, and design of clinical studies for oncology indications (including hematologic malignancies and solid tumors). The guidance announced in this notice finalizes the draft guidance of the same title dated March 2022.
Human Gene Therapy Products Incorporating Human Genome Editing; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Human Gene Therapy Products Incorporating Human Genome Editing; Guidance for Industry.'' The guidance document provides recommendations to sponsors developing human gene therapy products incorporating genome editing (GE) of human somatic cells. Specifically, the guidance provides recommendations regarding information that should be provided in an investigational new drug (IND) application to assess the safety and quality of the investigational GE product, including information on product design, product manufacturing and testing, nonclinical safety assessment, and clinical trial design. The guidance announced in this notice finalizes the draft guidance of the same title dated March 2022.
Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-October Through December 2023
This quarterly notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published in the 3-month period, relating to the Medicare and Medicaid programs and other programs administered by CMS.
Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for Food and Drug Administration-Regulated Medical Products; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products.'' The purpose of this guidance is to provide FDA's expectations for, and recommendations on, use of a standardized approach for collecting and reporting race and ethnicity data in submissions including information collected and reported from clinical studies and clinical trials for FDA-regulated medical products. Using standard terminology for race and ethnicity helps ensure that data are collected and reported consistently in submissions to FDA. This draft guidance revises the final guidance for industry and FDA staff entitled ``Collection of Race and Ethnicity Data in Clinical Trials'' issued on October 26, 2016.
Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Oncologic Drugs Advisory Committee (the Committee). The general function of the Committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Food Additives Permitted in Feed and Drinking Water of Animals; Chromium Propionate
The Food and Drug Administration (FDA, we, or the Agency) is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of chromium propionate as a source of chromium in turkey feed. This action is in response to a food additive petition filed by Kemin Industries, Inc.
Medicare Program; Request for Information on Medicare Advantage Data
This request for information (RFI) seeks input from the public regarding various aspects of Medicare Advantage (MA) data. Responses to this RFI may be used to inform general efforts to strengthen Centers for Medicare & Medicaid Services' (CMS') MA data capabilities and guide policymaking.
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