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

In accordance with the requirements of the Privacy Act of 1974, as amended, the Department of Health and Human Services (HHS) is modifying an existing system of records maintained by the Administration for Children and Families (ACF), Office of Child Support Services (OCSS): System No. 09-80-0389, "OCSE Data Center General Support System," being renamed "OCSS Data Exchange Platform."

In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC) announces the following meeting of the Subcommittee for Procedure Reviews (SPR) of the Advisory Board on Radiation and Worker Health (ABRWH or the Advisory Board). This meeting is open to the public, but without a public comment period. The public is welcome to submit written comments in advance of the meeting, to the contact person below. Written comments received in advance of the meeting will be included in the official record of the meeting. The public is also welcomed to listen to the meeting by joining the audio conference (information below). The audio conference line has 150 ports for callers.

Notice is hereby given of a change in the meeting of the Advisory Board on Radiation and Worker Health, National Institute for Occupational Safety and Health (ABRWH); February 14, 2024, 11 a.m. to 1 p.m. EST, teleconference/web conference, in the original Federal Register notice. The meeting notice was published in the Federal Register on December 18, 2023. The meeting notice is being corrected to change the executive order number.

Notice is hereby given of a change in the meeting of the Advisory Board on Radiation and Worker Health, National Institute for Occupational Safety and Health (ABRWH); April 17, 2024, 9:15 a.m. to 6 p.m. EDT, teleconference/web conference, in the original Federal Register notice. The meeting notice was published in the Federal Register on March 4, 2024 and is being corrected to change the executive order number in Supplementary Information.

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 or we) is announcing that we have filed a petition, submitted by Lonza Greenwood LLC, proposing that the color additive regulations be amended to provide for the safe use of sodium copper chlorophyllin in dietary supplement capsules in an amount ranging from 0.08 to 0.4 percent of the weight of the capsule, and to add fescue grass (Festuca arundinacea) as a permitted source of the color additive.

This proposed rule describes a new mandatory Medicare payment model, the Increasing Organ Transplant Access Model (IOTA Model), that would test whether performance-based incentive payments paid to or owed by participating kidney transplant hospitals increase access to kidney transplants for patients with end-stage renal disease (ESRD) while preserving or enhancing the quality of care and reducing Medicare expenditures. This proposed rule also includes standard provisions that would apply to Innovation Center models whose first performance period begins on or after January 1, 2025, and also would apply, in whole or part, to any Innovation Center model whose first performance period begins prior to January 1, 2025 should such model's governing documentation incorporate the provisions by reference in whole or in part. The proposed standard provisions relate to beneficiary protections; cooperation in model evaluation and monitoring; audits and records retention; rights in data and intellectual property; monitoring and compliance; remedial action; model termination by CMS; limitations on review; miscellaneous provisions on bankruptcy and other notifications; and the reconsideration review process.

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 Office of Community Services (OCS), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is proposing a new information collection for an evaluation of a new demonstration program, the Medical-Legal Partnerships Plus (MLP+). The information collection will include grant recipient reports of service delivery and outcomes, as well as interviews with program staff and participants to understand program implementation and participant experiences.

The Food and Drug Administration (FDA or Agency) is announcing the issuance of Emergency Use Authorizations (EUAs) (the Authorizations) for certain medical devices related to Coronavirus Disease 2019 (COVID-19). FDA has issued the Authorizations listed in this document under the Federal Food, Drug, and Cosmetic Act (FD&C Act). These Authorizations contain, among other things, conditions on the emergency use of the authorized products. The Authorization follows the February 4, 2020, determination by the Secretary of Health and Human Services (HHS), as amended on March 15, 2023, that there is a public health emergency, or a significant potential for a public health emergency, that affects, or has a significant potential to affect, national security or the health and security of U.S. citizens living abroad and that involves the virus that causes COVID-19, and the subsequent declarations on February 4, 2020, March 2, 2020, and March 24, 2020, that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of the virus that causes COVID-19, personal respiratory protective devices, and medical devices, including alternative products used as medical devices, respectively, subject to the terms of any authorization issued under the FD&C Act. These Authorizations, which include an explanation of the reasons for issuance, are listed in this document, and can be accessed on FDA's website from the links indicated.

The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that XOLREMDI (mavorixafor), approved on April 26, 2024, manufactured by X4 Pharmaceuticals, Inc., meets the criteria for a priority review voucher.

The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during January, February, and March 2024. The animal drug regulations are also being amended to improve their accuracy and readability.

The Food and Drug Administration (FDA, the Agency, or we) is amending the animal drug regulations for labeling of new animal drugs included on FDA's Index of Legally Marketed Unapproved New Animal Drugs for Minor Species (indexed products) to reflect the 2018 statutory changes to the Federal Food, Drug, and Cosmetic Act (FD&C Act). This amendment is intended to ensure accuracy and clarity in the Agency's regulations. This amendment is nonsubstantive.

In compliance with the requirement 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. The ICR is for extending the use of the approved information collection assigned OMB control number 0937-0191, which expires on June 30, 2024. Prior to submitting the ICR to OMB, OS seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

The Department of Health and Human Services, National Institutes of Health published a Notice in the Federal Register on May 9, 2024. That Notice requires a correction in the DATES section.

The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that OJEMDA (tovorafenib), approved on April 23, 2024, manufactured by Day One Biopharmaceuticals, Inc., meets the criteria for a priority review voucher.

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.