Department of Health and Human Services 2022 – Federal Register Recent Federal Regulation Documents
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Solicitation for Nominations for Members of the U.S. Preventive Services Task Force (USPSTF)
The Agency for Healthcare Research and Quality (AHRQ) invites nominations of individuals qualified to serve as members of the U.S. Preventive Services Task Force (USPSTF).
Agency Information Collection Activities: Submission for OMB Review; Comment Request
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.
Authorization of Emergency Use of an In Vitro Diagnostic Device in Response to an Outbreak of Mpox; Availability
The Food and Drug Administration (FDA) is announcing the issuance of an Emergency Use Authorization (EUA) (the Authorization) under the Federal Food, Drug, and Cosmetic Act (FD&C Act) in response to an outbreak of mpox. FDA has issued an Authorization for an in vitro diagnostic device as requested by Roche Molecular Systems, Inc. The Authorization contains, among other things, conditions on the emergency use of the authorized product. The Authorization follows the August 9, 2022, determination by the Secretary of Health and Human Services (HHS) 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 monkeypox virus. On the basis of such determination, the Secretary of HHS declared, on September 7, 2022, that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of infection with the monkeypox virus, including in vitro diagnostics that detect and/or diagnose infection with non-variola Orthopoxvirus, pursuant to the FD&C Act, subject to terms of any authorization issued under that section. The Authorization, which includes an explanation of the reasons for issuance, is reprinted in this document.
Prospective Grant of an Exclusive Patent License: Development and Commercialization of Natural Killer Cell Therapies for Cancer
The National Cancer Institute, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the Supplementary Information section of this notice to Replay Holdings LLC (``Replay'') located in San Diego, California.
Medicare Program; End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals With Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, and End-Stage Renal Disease Treatment Choices Model; Correction
This document corrects technical errors that appeared in the November 7, 2022 Federal Register in the final rule entitled ``Medicare Program; End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals With Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, and End- Stage Renal Disease Treatment Choices Model'' (referred to hereafter as the calendar year (CY) 2023 ESRD PPS final rule).
Medicare Program; Implementing Certain Provisions of the Consolidated Appropriations Act, 2021 and Other Revisions to Medicare Enrollment and Eligibility Rules; Correction
This document corrects technical and typographical errors that appeared in the final rule published in the Federal Register on November 3, 2022, entitled ``Medicare Program; Implementing Certain Provisions of the Consolidated Appropriations Act, 2021 and other Revisions to Medicare Enrollment and Eligibility Rules.''
Acute Radiation Syndrome Medical Countermeasures-Amendment
The Secretary is amending the Declaration issued in the Federal Register of October 10, 2008, and as amended and republished January 1, 2016, pursuant to the Public Health Service Act, to extend the effective time period of the Republished Declaration, as amended.
Patient Safety Organizations: Voluntary Relinquishment for the Zephcare PSO
The Patient Safety and Quality Improvement Final Rule (Patient Safety Rule) authorizes AHRQ, on behalf of the Secretary of HHS, to list as a patient safety organization (PSO) an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be ``delisted'' by the Secretary if it is found to no longer meet the requirements of the Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act) and Patient Safety Rule, when a PSO chooses to voluntarily relinquish its status as a PSO for any reason, or when a PSO's listing expires. AHRQ accepted a notification of proposed voluntary relinquishment from the Zephcare PSO, PSO number P0200, of its status as a PSO, and has delisted the PSO accordingly.
Medical Devices; Neurological Devices; Classification of the Pediatric Autism Spectrum Disorder Diagnosis Aid
The Food and Drug Administration (FDA, Agency, or we) is classifying the pediatric Autism Spectrum Disorder (ASD) diagnosis aid 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 pediatric Autism Spectrum Disorder diagnosis aid'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.
Submission for Office of Management and Budget Review; Tribal Maternal, Infant, and Early Childhood Home Visiting Program: Guidance for Submitting an Annual Report to the Secretary (Office of Management and Budget #0970-0409)
The Administration for Children and Families (ACF), Office of Early Childhood Development (ECD) is requesting revisions to the Tribal Maternal, Infant, and Early Childhood Home Visiting Program (Tribal MIECHV) Guidance for Submitting Reports to the Secretary (Office of Management and Budget (OMB) #0970-0409; expiration September 30, 2024). Guidance under this OMB number includes that for an annual report and that for a final report. This request is for review of the final report guidance. There are no changes proposed to the guidance for the annual report.
Submission for OMB Review; Temporary Assistance for Needy Families (TANF) Financial Report, ACF-196T (OMB #0970-0345)
The Administration for Children and Families (ACF) is requesting a 3-year extension of the Temporary Assistance for Needy Families (TANF) Financial Report, Form ACF-196T (Office of Management and Budget (OMB) #0970-0345, expiration April 30, 2023). ACF is proposing minor updates to the form to remove a reporting line-item reference that was associated with an expired program expenditure and minor edits to the instructions and formatting to better the presentation of the document.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Data Collection Tool for State Offices of Rural Health Grant Program
In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
National Vaccine Injury Compensation Program; List of Petitions Received
HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by the Public Health Service (PHS) Act, as amended. While the Secretary of HHS is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.
Meetings of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that a meeting is scheduled to be held for the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (PACCARB). The meeting will be open to the public via Zoom and teleconference; a pre- registered public comment session will be held during the meeting. Pre- registration is required for members of the public who wish to present their comments at the meeting via Zoom/teleconference. Individuals who wish to send in their written public comment should send an email to CARB@hhs.gov. Registration information is available on the website https://www.hhs.gov/paccarb and must be completed by January 18, 2023 for the January 24-25, 2023 Public Meeting. Additional information about registering for the meeting and providing public comment can be obtained at https://www.hhs.gov/paccarb on the Upcoming Meetings page.
Medical Devices; Cardiovascular Devices; Classification of the Interventional Cardiovascular Implant Simulation Software Device
The Food and Drug Administration (FDA, Agency or we) is classifying the interventional cardiovascular implant simulation software device 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 interventional cardiovascular implant simulation software device'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.
Medicare Program; Contract Year 2024 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, Medicare Parts A, B, C, and D Overpayment Provisions of the Affordable Care Act and Programs of All-Inclusive Care for the Elderly; Health Information Technology Standards and Implementation Specifications
This proposed rule would revise the Medicare Advantage (Part C), Medicare Prescription Drug Benefit (Part D), Medicare cost plan, and Programs of All-Inclusive Care for the Elderly (PACE) regulations to implement changes related to Star Ratings, medication therapy management, marketing and communications, health equity, provider directories, coverage criteria, prior authorization, passive enrollment, network adequacy, identification of overpayments, formulary changes, and other programmatic areas. This proposed rule would also codify regulations implementing section 118 of Division CC of the Consolidated Appropriations Act, 2021, section 11404 of the Inflation Reduction Act, and includes a large number of provisions that would codify existing sub-regulatory guidance in the Part C, Part D, and PACE programs. This proposed rule would also amend the existing regulations for Medicare Parts A, B, C, and D regarding the standard for an identified overpayment.
Medical Devices; Cardiovascular Devices; Classification of the Adjunctive Hemodynamic Indicator With Decision Point
The Food and Drug Administration (FDA, Agency, or we) is classifying the adjunctive hemodynamic indicator with decision point 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 adjunctive hemodynamic indicator with decision point'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.
Submission for Office of Management and Budget Review; Child Welfare Study To Enhance Equity With Data (New Collection)
The Office of Planning, Research, and Evaluation (OPRE) within the Administration for Children and Families (ACF) is proposing a new information collection for the Child Welfare Study to Enhance Equity with Data (CW-SEED). The project aims to understand how and to what extent data are used to explore equity in service delivery and child and family outcomes, to identify barriers or problematic data practices, and to explore efforts by child welfare agencies and their partners to use data to reduce barriers across the continuum of child welfare services.
Medical Devices; Immunology and Microbiology Devices; Classification of the Human Leukocyte Antigen Typing Companion Diagnostic Test
The Food and Drug Administration (FDA, Agency, or we) is classifying the human leukocyte antigen typing companion diagnostic test 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 human leukocyte antigen typing companion diagnostic test'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.
Submission for Office of Management and Budget Review; Tribal Child Support Enforcement Direct Funding Request
The Office of Child Support Enforcement (OCSE), Administration for Children and Families (ACF) is requesting a 3-year extension of the Tribal Child Support Enforcement Direct Funding Requests-45 CFR 309 (Office of Management and Budget (OMB)) #0970-0218, expiration March 31, 2023) with revisions. We are proposing to provide an optional Table of Contents and Cover Sheet for plan pages.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
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.
Notice of Amendment
The Secretary is amending the Declaration issued in the Federal Register of August 1, 2016 as amended and republished August 1, 2018, pursuant to section 319F-3 of the Public Health Service Act, to extend the effective time period of the Republished Declaration, as amended.
Notice of amendment
The Secretary is amending the Declaration issued in the Federal Register of October 10, 2008, as amended April 26, 2009; December 17, 2008; February 29, 2012; and as amended and republished January 1, 2016, pursuant to section 319F-3 of the Public Health Service Act to extend the effective time period of the Republished Declaration, as amended.
Notice of Amendment
The Secretary is amending the Declaration issued in the Federal Register of April 11, 2017, pursuant to section 319F-3 of the Public Health Service Act to extend the effective time period of the Declaration.
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