Department of Health and Human Services October 20, 2021 – Federal Register Recent Federal Regulation Documents

Proposed Collection; 60-Day Comment Request; Collection of Customer Service, Demographic, and Smoking/Tobacco Use Information From the National Cancer Institute's (NCI) Cancer Information Service (CIS)
Document Number: 2021-22875
Type: Notice
Date: 2021-10-20
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the requirements of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI) will publish periodic summaries of propose projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; COVID-19 Provider Relief Fund (PRF) Reporting Activities, OMB No. 0906-XXXX-New
Document Number: 2021-22831
Type: Notice
Date: 2021-10-20
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with of the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. OMB may act on HRSA's ICR only after the 30 day comment period for this notice has closed.
National Heart, Lung, and Blood Institute; Notice of Meeting
Document Number: 2021-22828
Type: Notice
Date: 2021-10-20
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2021-22827
Type: Notice
Date: 2021-10-20
Agency: Department of Health and Human Services, National Institutes of Health
Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2022 Rates; Quality Programs and Medicare Promoting Interoperability Program Requirements for Eligible Hospitals and Critical Access Hospitals; Changes to Medicaid Provider Enrollment; and Changes to the Medicare Shared Savings Program; Corrections
Document Number: 2021-22724
Type: Rule
Date: 2021-10-20
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document corrects technical and typographical errors in the final rule that appeared in the August 13, 2021, issue of the Federal Register titled ``Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2022 Rates; Quality Programs and Medicare Promoting Interoperability Program Requirements for Eligible Hospitals and Critical Access Hospitals; Changes to Medicaid Provider Enrollment; and Changes to the Medicare Shared Savings Program.''
Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2021-22612
Type: Notice
Date: 2021-10-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products.'' The FDA Reauthorization Act of 2017 (FDARA) directed FDA to update and finalize the draft guidance entitled ``Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products,'' issued on November 7, 2013. Therefore, FDA is issuing this updated draft guidance, which supersedes the November 7, 2013, draft guidance. This updated draft guidance is intended to describe hearing aids, personal sound amplification products (PSAPs), their respective intended uses, and the regulatory requirements that apply to these products. This draft guidance is not final nor is it in effect at this time.
New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship
Document Number: 2021-22604
Type: Rule
Date: 2021-10-20
Agency: Food and Drug Administration, Department of Health and Human Services
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), abbreviated new animal drug applications (ANADAs), and conditional new animal drug applications (cNADAs) during January, February, and March 2021. 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 and readability of the regulations.
Department of Health and Human Services Proposed Repeal of HHS Rules on Guidance, Enforcement, and Adjudication Procedures
Document Number: 2021-22503
Type: Proposed Rule
Date: 2021-10-20
Agency: Department of Health and Human Services
The Department of Health and Human Services (HHS or the Department) is proposing to repeal two final rules: ``Department of Health and Human Services Good Guidance Practices,'' published in the Federal Register of December 7, 2020; and ``Department of Health and Human Services Transparency and Fairness in Civil Administrative Enforcement Actions,'' published in the Federal Register of January 14, 2021.
Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids
Document Number: 2021-22473
Type: Proposed Rule
Date: 2021-10-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, we, or the Agency) is proposing to establish a regulatory category for over-the-counter (OTC) hearing aids and to make related amendments to update the regulatory framework for hearing aids. Specifically, we propose to define OTC hearing aids and establish applicable requirements; amend existing rules for consistency with a new OTC category; repeal the conditions for sale applicable to hearing aids; amend the existing labeling requirements for hearing aids; and update regulations relating to decisions on applications for exemption from Federal preemption that would become obsolete as a result of changes to the hearing aid requirements. This action, if finalized, would more clearly define prescription hearing aids; however, it would not change the classification of existing device types. In creating a regulatory category for OTC hearing aids and amending existing rules, we intend to provide reasonable assurance of safety and effectiveness for these devices as well as foster access to, and innovation in, hearing aid technology, thereby protecting and promoting the public health.