Department of Health and Human Services September 2022 – Federal Register Recent Federal Regulation Documents
Results 1 - 50 of 338
Agency Information Collection Activities: Proposed Collection: Public Comment Request
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.
Medicare Program; Medicare Appeals; Adjustment to the Amount in Controversy Threshold Amounts for Calendar Year 2023
This notice announces the annual adjustment in the amount in controversy (AIC) threshold amounts for Administrative Law Judge (ALJ) hearings and judicial review under the Medicare appeals process. The adjustment to the AIC threshold amounts will be effective for requests for ALJ hearings and judicial review filed on or after January 1, 2023. The calendar year 2023 AIC threshold amounts are $180 for ALJ hearings and $1,850 for judicial review.
Agency Information Collection Activities: Proposed Collection; Public Comment Request; Traumatic Brain Injury (TBI) State Partnership Program Performance Measures (OMB Control Number 0985-0066)
The Administration for Community Living (ACL) is announcing an opportunity for the public to comment on the proposed collection of information listed above. Under the Paperwork Reduction Act of 1995 (PRA), Federal agencies are required to publish a notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This IC Extension solicits comments on the information collection requirements relating to the Traumatic Brain Injury (TBI) State Partnership Program.
Medicare and Medicaid Programs: Application From The Joint Commission (TJC) for Continued Approval of its Psychiatric Hospital Accreditation Program
This proposed notice acknowledges the receipt of an application from The Joint Commission for continued recognition as a national accrediting organization for psychiatric hospitals that wish to participate in the Medicare or Medicaid programs.
Animal Generic Drug User Fee Act; Public Meeting; Request for Comments
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public meeting entitled ``Animal Generic Drug User Fee Act.'' The purpose of the meeting is to discuss the proposed recommendations for the reauthorization of the Animal Generic Drug User Fee Act (AGDUFA IV) for fiscal years 2024 through 2028.
Proposed Reallotment of Fiscal Year 2021 Funds for the Low Income Home Energy Assistance Program
The ACF, OCS, Division of Energy Assistance (DEA) announces a preliminary determination that funds from the federal fiscal year (FFY) 2021 Low Income Home Energy Assistance Program (LIHEAP) are available for reallotment to states, territories, tribes, and tribal organizations that received FFY 2022 direct LIHEAP grants. The purpose of this award is to redistribute FFY 2021 annual LIHEAP funds that grant recipients were unable to obligate or carry over to FFY 2022. No sub-recipients of these grant recipients or other entities may apply for these funds.
Proposed Data Collection Submitted for Public Comment and Recommendations
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other federal agencies the opportunity to comment on a continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled the Collaborating Center for Questionnaire Design and Evaluation Research (CCQDER). This Generic Clearance request allows CDC to conduct cognitive testing activities, and includes a general questionnaire for development, pre-testing, and measurement-error reduction activities to be carried out in 2022-2025.
Proposed Data Collection Submitted for Public Comment and Recommendations
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other federal agencies the opportunity to comment on a continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Developmental Studies to improve the National Health Care Surveys. The goal of the project is to cover new survey research that will evaluate and improve upon survey design and operations, as well as examine the feasibility and address challenges that may arise with future expansions of the National Health Care Surveys.
Proposed Data Collection Submitted for Public Comment and Recommendations
The Agency for Toxic Substances and Disease Registry (ATSDR), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other federal agencies the opportunity to comment on a continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled ``National Amyotrophic Lateral Sclerosis (ALS) Registry.'' The National ALS Registry collects information from persons with ALS to better describe the prevalence and potential risk factors for ALS.
New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor Name and Address
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 2022. FDA is informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to improve the accuracy of the regulations.
Food Labeling: Nutrient Content Claims; Definition of Term “Healthy”
The Food and Drug Administration (FDA or we) is proposing to update the definition for the implied nutrient content claim ``healthy'' to be consistent with current nutrition science and Federal dietary guidance, especially the Dietary Guidelines for Americans (Dietary Guidelines), regarding how consumers can maintain healthy dietary practices. This action, if finalized, will revise the requirements for when the term ``healthy'' can be used as an implied claim in the labeling of human food products to indicate that a food's level of nutrients may help consumers maintain healthy dietary practices by helping them achieve a total diet that conforms to dietary recommendations.
Medicare Program; Medicare Part B Monthly Actuarial Rates, Premium Rates, and Annual Deductible Beginning January 1, 2023
This notice announces the monthly actuarial rates for aged (age 65 and over) and disabled (under age 65) beneficiaries enrolled in Part B of the Medicare Supplementary Medical Insurance (SMI) program beginning January 1, 2023. In addition, this notice announces the monthly premium for aged and disabled beneficiaries, the deductible for 2023, and the income-related monthly adjustment amounts to be paid by beneficiaries with modified adjusted gross income above certain threshold amounts.
Submission for OMB Review; 45 CFR 303.7-Provision of Services in Intergovernmental IV-D; Federally Approved Forms (OMB #0970-0085)
The Office of Child Support Enforcement is requesting a 3-year extension of the Provision of Services in Intergovernmental IV-D; Federally Approved Forms (OMB #0970-0085, expiration December 31, 2022). There are no changes requested to these forms.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Data System for Organ Procurement and Transplantation Network, OMB No. 0915-0157-Revision
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.
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.
Agency Information Collection Activities: Proposed Collection; 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 (the 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.
Submission for OMB Review; Office of Community Services (OCS) Community Economic Development (CED) Standard Reporting Format (Office of Management and Budget); (OMB) #0970-0386)
OCS is requesting a three-year extension of the semi-annual reporting format for CED grant recipients, the Performance Progress Report (PPR), which collects information regarding the outcomes and management of CED projects (OMB #0970-0386, expiration February 28, 2023). There are minor changes requested to the form to provide clarity to users completing the form.
Agency Information Collection Activities; Submission for OMB Review; Public Comment Request; Older Americans Act, Application for Title VI Parts A/B and C Grants OMB Control Number 0985-0064
The Administration for Community Living is announcing that the proposed collection of information listed above has been submitted to the Office of Management and Budget (OMB) for review and clearance as required under the Paperwork Reduction Act of 1995. This 30-day notice collects comments on the information collection requirements related to the information collection requirements for the Older Americans Act, Title VI Parts A/B and C Grants PPR OMB Control Number 0985-0064.
Medicare Program; CY 2023 Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance Amounts
This notice announces the inpatient hospital deductible and the hospital and extended care services coinsurance amounts for services furnished in calendar year (CY) 2023 under Medicare's Hospital Insurance Program (Medicare Part A). The Medicare statute specifies the formulae used to determine these amounts.
Meeting of the Secretary's Advisory Committee on Human Research Protections
Pursuant to Section 10(a) of the Federal Advisory Committee Act, notice is hereby given that the Secretary's Advisory Committee on Human Research Protections (SACHRP) will hold a meeting that will be open to the public. Information about SACHRP, the full meeting agenda, and instructions for linking to public access will be posted on the SACHRP website at https://www.hhs.gov/ohrp/sachrp-committee/meetings/ index.html.
Agency Information Collection Activities: Proposed Collection: Public Comment Request Information Collection Request Title: Nurse Corps Loan Repayment Program; OMB No. 0915-0140 Extension
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.
Medicare Program; CY 2023 Part A Premiums for the Uninsured Aged and for Certain Disabled Individuals Who Have Exhausted Other Entitlement
This notice announces Medicare's Hospital Insurance Program (Medicare Part A) premium for uninsured enrollees in calendar year 2023. This premium is paid by enrollees age 65 and over who are not otherwise eligible for benefits under Medicare Part A (hereafter known as the ``uninsured aged'') and by certain individuals with disabilities who have exhausted other entitlement. The monthly Medicare Part A premium for the 12 months beginning January 1, 2023 for these individuals will be $506. The premium for certain other individuals as described in this notice will be $278.
Proposed Information Collection Activity; Human Trafficking Youth Prevention Education Demonstration Grant Program Process Evaluation (New Collection)
The Office of Planning, Research, and Evaluation (OPRE), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), in collaboration with the Office on Trafficking in Persons (OTIP), is proposing a new data collection activity for the Human Trafficking Youth Prevention Education (HTYPE) Demonstration Grant Program Process Evaluation. The process evaluation will explore whether the program is being implemented as intended, describe the successes and barriers that have been encountered, and highlight the changes that may be needed to support program implementation.
Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised); Immediately in Effect Guidance for Commercial Manufacturers and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance document related to the Coronavirus Disease 2019 (COVID-19) public health emergency (PHE) entitled ``Policy for Coronavirus Disease2019 Tests During the Public Health Emergency (Revised).'' FDA is issuing this guidance to provide FDA's revised enforcement policies and review priorities regarding certain novel coronavirus (COVID-19) tests for the duration of the public health emergency. Rapid detection of COVID-19 cases in the United States requires wide availability of testing to control the spread of this highly contagious infection. This document supersedes ``Policy for Coronavirus Disease2019 Tests During the Public Health Emergency (Revised)'' issued November 15, 2021. The guidance identified in this notice addresses issues related to the COVID-19 PHE and has been issued in accordance with the expedited process FDA announced in the Federal Register of March 25, 2020, for making available to the public COVID-19-related guidances. This guidance has been implemented without prior comment, but it remains subject to comment in accordance with the Agency's good guidance practices.
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP); Notice of Charter Renewal
This gives notice under the Federal Advisory Committee Act of October 6, 1972, that the Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP), Centers for Disease Control and Prevention, Department of Health and Human Services, has been renewed for a 2-year period through September 18, 2024.
Proposed Information Collection Activity; 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.
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