Department of Health and Human Services September 29, 2022 – Federal Register Recent Federal Regulation Documents
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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.
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