Department of Health and Human Services November 18, 2022 – Federal Register Recent Federal Regulation Documents

Proposed Information Collection Activity; Generic Clearance for Reviewer Recruitment Forms
Document Number: 2022-25202
Type: Notice
Date: 2022-11-18
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF) proposes to extend approval of the existing overarching generic clearance for Reviewer Recruitment Forms (Office of Management and Budget (OMB) #0970-0477). No changes are proposed to the terms of the overarching generic.
Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability
Document Number: 2022-25210
Type: Notice
Date: 2022-11-18
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 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 guidances identified in this notice were developed using the process described in that guidance.
Medicare and Medicaid Programs; CY 2023 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; Implementing Requirements for Manufacturers of Certain Single-dose Container or Single-use Package Drugs To Provide Refunds With Respect to Discarded Amounts; and COVID-19 Interim Final Rules
Document Number: 2022-23873
Type: Rule
Date: 2022-11-18
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This major final rule addresses: changes to the physician fee schedule (PFS); other changes to Medicare Part B payment policies to ensure that payment systems are updated to reflect changes in medical practice, relative value of services, and changes in the statute; Medicare Shared Savings Program requirements; updates to the Quality Payment Program; Medicare coverage of opioid use disorder services furnished by opioid treatment programs; updates to certain Medicare and Medicaid provider enrollment policies, including for skilled nursing facilities; updates to conditions of payment for DMEPOS suppliers; HCPCS Level II coding and payment for wound care management products; electronic prescribing for controlled substances for a covered Part D drug under a prescription drug plan or an MA-PD plan under the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act (SUPPORT Act); updates to the Medicare Ground Ambulance Data Collection System; provisions under the Infrastructure Investment and Jobs Act; and finalizes the CY 2022 Methadone Payment Exception for Opioid Treatment Programs IFC. We are also finalizing, as implemented, a few provisions included in the COVID-19 interim final rules with comment period.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2022-25176
Type: Notice
Date: 2022-11-18
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) reapprove the proposed information collection project: ``Medical Expenditure Panel SurveyInsurance Component.'' This proposed information collection was previously published in the Federal Register on September 6th, 2022 and allowed 60 days for public comment. AHRQ received no substantive comments from members of the public during this period. The purpose of this notice is to allow an additional 30 days for public comment.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2022-25167
Type: Notice
Date: 2022-11-18
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Meetings
Document Number: 2022-25165
Type: Notice
Date: 2022-11-18
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2022-25164
Type: Notice
Date: 2022-11-18
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2022-25162
Type: Notice
Date: 2022-11-18
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 (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.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.