Department of Health and Human Services January 2024 – Federal Register Recent Federal Regulation Documents

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.

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register on December 21, 2023. The document announced the availability of a final guidance for industry entitled ``Development of Monoclonal Antibody Products Targeting SARS- CoV-2 for Emergency Use Authorization.'' The document was published with an incorrect docket number. This document corrects that error.

This document corrects technical errors in the final rule that appeared in the November 13, 2023 Federal Register titled ``Medicare Program; Calendar Year (CY) 2024 Home Health (HH) Prospective Payment System Rate Update; HH Quality Reporting Program Requirements; HH Value-Based Purchasing Expanded Model Requirements; Home Intravenous Immune Globulin Items and Services; Hospice Informal Dispute Resolution and Special Focus Program Requirements, Certain Requirements for Durable Medical Equipment Prosthetics and Orthotics Supplies; and Provider and Supplier Enrollment Requirements'' (referred to hereafter as the ``CY 2024 HH PPS final rule'').

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.

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.

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.

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.

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.

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project ``Generic Clearance for Questionnaire and Data Collection Testing, Evaluation, and Research for the Agency for Healthcare Research and Quality.'' This proposed information collection was previously published in the Federal Register on November 13th, 2023 and allowed 60 days for public comment. AHRQ received no substantive comments from members of the public. The purpose of this notice is to allow an additional 30 days for public comment.

In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH), Office of the Director, Office of Acquisitions and Logistics Management (OALM), Small Business Program Office (SBPO), has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.

The Food and Drug Administration (FDA or Agency) is announcing the availability for comment of a revised draft guidance for industry entitled ``Conducting Remote Regulatory AssessmentsQuestion and Answers.'' FDA has revised and is reissuing the draft guidance in response to public comments and recent amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act). When finalized, this guidance will describe FDA's current thinking regarding its use of remote regulatory assessments (RRAs). FDA has used RRAs to conduct oversight, mitigate risk, meet critical public health needs, and help maximize compliance of FDA-regulated products. This revised draft guidance provides answers to frequently asked questions regarding RRAs.

The Food and Drug Administration (FDA) 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.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final document entitled ``Best Practices for FDA Staff in the Postmarketing Safety Surveillance of Human Drug and Biological Products.'' The 21st Century Cures Act (Cures Act), enacted on December 13, 2016, requires that FDA make publicly available on its internet website best practices for certain postmarketing drug safety surveillance activities. This final document sets forth risk-based principles for FDA's conduct of ongoing postmarketing safety surveillance for human drug products and human biological products, in part, to address the Cures Act requirements. This document finalizes the draft document entitled ``Best Practices in Drug and Biological Product Postmarket Safety Surveillance for FDA Staff'' that was issued on November 7, 2019.