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

National Cancer Institute; Amended Notice of Meeting
Document Number: 2024-10873
Type: Notice
Date: 2024-05-17
Agency: Department of Health and Human Services, National Institutes of Health
Notice of Proposed Purchased/Referred Care Delivery Area Re-Designation for the Pokagon Band of Potawatomi Indians of Michigan and Indiana
Document Number: 2024-10845
Type: Notice
Date: 2024-05-17
Agency: Department of Health and Human Services, Indian Health Service
This Notice advises the public that the Indian Health Service (IHS) proposes to expand the geographic boundaries of the Purchased/ Referred Care Delivery Area (PRCDA) for the Pokagon Band of Potawatomi Indians of Michigan and Indiana to include the counties of Kalamazoo, Kent, and Ottawa in the State of Michigan. The sole purpose of this expansion would be to authorize additional Pokagon Band of Potawatomi Indians of Michigan and Indiana citizens and other PRC-eligible individuals to receive PRC services.
Privacy Act of 1974; System of Records
Document Number: 2024-10838
Type: Notice
Date: 2024-05-17
Agency: Department of Health and Human Services, Administration for Children and Families
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."
Advisory Committee on Immunization Practices (ACIP); Notice of Charter Renewal
Document Number: 2024-10835
Type: Notice
Date: 2024-05-17
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
This gives notice under the Federal Advisory Committee Act of October 6, 1972, that the Advisory Committee on Immunization Practices (ACIP), Centers for Disease Control and Prevention, Department of Health and Human Services, has been renewed for a 2-year period through April 1, 2026.
Meeting of the Advisory Board on Radiation and Worker Health (ABRWH), Subcommittee for Procedure Reviews, National Institute for Occupational Safety and Health (NIOSH)
Document Number: 2024-10834
Type: Notice
Date: 2024-05-17
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
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.
Advisory Board on Radiation and Worker Health, National Institute for Occupational Safety and Health; Correction
Document Number: 2024-10833
Type: Notice
Date: 2024-05-17
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
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); June 26, 2024, 11 a.m. to 1 p.m. EDT, teleconference/web conference, in the original Federal Register notice. The meeting notice was published in the Federal Register on April 15, 2024 and is being corrected to change the executive order number in Supplementary Information.
Advisory Board on Radiation and Worker Health, National Institute for Occupational Safety and Health; Correction
Document Number: 2024-10832
Type: Notice
Date: 2024-05-17
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
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.
Advisory Board on Radiation and Worker Health, National Institute for Occupational Safety and Health; Correction
Document Number: 2024-10831
Type: Notice
Date: 2024-05-17
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
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); December 7, 2023, 11 a.m. to 6 p.m. EST, teleconference/web conference, in the original Federal Register notice. The meeting notice was published in the Federal Register on November 17, 2023. The meeting notice is being corrected to change the executive order number.
Advisory Board on Radiation and Worker Health, National Institute for Occupational Safety and Health; Correction
Document Number: 2024-10830
Type: Notice
Date: 2024-05-17
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
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.
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting
Document Number: 2024-10886
Type: Notice
Date: 2024-05-17
Agency: Department of Health and Human Services, National Institutes of Health
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2024-10877
Type: Notice
Date: 2024-05-17
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2024-10874
Type: Notice
Date: 2024-05-17
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2024-10900
Type: Notice
Date: 2024-05-17
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.
Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability
Document Number: 2024-10896
Type: Notice
Date: 2024-05-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of additional draft and revised draft product-specific guidances. The draft guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled "Bioequivalence Recommendations for Specific Products" that explained the process that would be used to make product-specific guidances available to the public on FDA's website. The draft guidances identified in this notice were developed using the process described in that guidance.
Lonza Greenwood LLC; Filing of Color Additive Petition
Document Number: 2024-10888
Type: Proposed Rule
Date: 2024-05-17
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Revocation of Two Authorizations of Emergency Use of In Vitro Diagnostic Device for Detection and/or Diagnosis of COVID-19; Availability
Document Number: 2024-10910
Type: Notice
Date: 2024-05-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorizations (EUAs) (the Authorizations) issued to Bio-Rad Laboratories Inc., for the Bio-Rad SARS-CoV-2 ddPCR Kit, and Fast Track Diagnostics Luxembourg S.[aacute].r.l. (A Siemens Healthineers Company), for the FTD SARS-CoV- 2. FDA revoked the Authorizations under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as requested by the Authorization holders. The revocations, which include an explanation of the reasons for each revocation, are reprinted at the end of this document.
Medicare Program; Alternative Payment Model Updates and the Increasing Organ Transplant Access (IOTA) Model
Document Number: 2024-09989
Type: Proposed Rule
Date: 2024-05-17
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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.
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