Department of Health and Human Services January 19, 2021 – Federal Register Recent Federal Regulation Documents

Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2022; Updates to State Innovation Waiver (Section 1332 Waiver) Implementing Regulations
Document Number: 2021-01175
Type: Rule
Date: 2021-01-19
Agency: Department of Health and Human Services, Department of the Treasury
This final rule sets forth provisions related to user fees for federally-facilitated Exchanges and State-based Exchanges on the Federal Platform. It includes changes related to acceptance of payments by issuers of individual market Qualified Health Plans and clarifies the regulation imposing network adequacy standards with regard to Qualified Health Plans that do not use provider networks. It also adds a new direct enrollment option for federally-facilitated Exchanges and State Exchanges and implements changes related to section 1332 State Innovation Waivers.
Administration for Children and Families
Document Number: 2021-01086
Type: Notice
Date: 2021-01-19
Agency: Department of Health and Human Services
The Administration for Children and Families (ACF) at the U.S. Department of Health and Human Services (HHS) requests an extension to continue data collection for the Phase II Evaluation Activities for Implementing a Next Generation Evaluation Agenda for the Chafee Foster Care Program for Successful Transition to Adulthood (OMB #0970-0489; Previously titled: Phase II Evaluation Activities for Implementing a Next Generation Evaluation Agenda for the Chafee Foster Care Independence Program). Information collection activities requested include interviews, focus group discussions and administrative data collection. There are no changes proposed to the currently approved materials.
Proposed Information Collection Activity; Placement and Transfer of Unaccompanied Alien Children Into ORR Care Provider Facilities (0970-0554)
Document Number: 2021-01085
Type: Notice
Date: 2021-01-19
Agency: Department of Health and Human Services, Administration for Children and Families
The Office of Refugee Resettlement (ORR), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is inviting public comments on revisions to an approved information collection. The request consists of several forms that allow the Unaccompanied Alien Children (UAC) Program to place UAC referred to ORR by Federal agencies into care provider facilities and to transfer UAC within the ORR care provider network.
Medicaid Program; Medicaid Fiscal Accountability Regulation
Document Number: 2021-01078
Type: Proposed Rule
Date: 2021-01-19
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document withdraws a proposed rule that was published in the Federal Register on November 18, 2019. The proposed rule would have established new reporting requirements and codified other Medicaid financing requirements, including related to permissible sources for non-federal share financing.
National Center for Advancing Translational Sciences; Notice of Closed Meeting
Document Number: 2021-01047
Type: Notice
Date: 2021-01-19
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Data To Support Drug Product Communications as Used by the Food and Drug Administration
Document Number: 2021-01030
Type: Notice
Date: 2021-01-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Authorizations of Emergency Use of Two Biological Products During the COVID-19 Pandemic; Availability
Document Number: 2021-01022
Type: Notice
Date: 2021-01-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the issuance of two Emergency Use Authorizations (EUAs) (the Authorizations) under the Federal Food, Drug, and Cosmetic Act (FD&C Act) for biological products for use during the COVID-19 pandemic. FDA issued one Authorization for a biological product as requested by Pfizer, Inc, and one Authorization for a biological product as requested by ModernaTX, Inc. The Authorizations contain, among other things, conditions on the emergency use of the authorized products. The Authorizations follow the February 4, 2020, determination by the Secretary of Health and Human Services (HHS) that there is a public health emergency that has a significant potential to affect national security or the health and security of U.S. citizens living abroad and that involves a novel (new) coronavirus. The virus, now named SARS-CoV- 2, causes the illness COVID-19. On the basis of such determination, the Secretary of HHS declared on March 27, 2020, that circumstances exist justifying the authorization of emergency use of drugs and biological products during the COVID-19 pandemic, pursuant to the FD&C Act, subject to the terms of any authorization issued under that section. The Authorizations, which include an explanation of the reasons for issuance, are reprinted in this document.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Information Collection Request Title: National Practitioner Data Bank for Adverse Information on Physicians and Other Health Care Practitioners-45 CFR Part 60 Regulations and Forms, OMB No. 0915-0126-Revision
Document Number: 2021-00989
Type: Notice
Date: 2021-01-19
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with the Paperwork Reduction Act of 1995, HRSA 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 Institute of General Medical Sciences; Notice of Closed Meetings
Document Number: 2021-00986
Type: Notice
Date: 2021-01-19
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting
Document Number: 2021-00985
Type: Notice
Date: 2021-01-19
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: 2021-00984
Type: Notice
Date: 2021-01-19
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2021-00980
Type: Notice
Date: 2021-01-19
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Minority Health and Health Disparities; Notice of Closed Meeting
Document Number: 2021-00979
Type: Notice
Date: 2021-01-19
Agency: Department of Health and Human Services, National Institutes of Health
Office of the Director Notice of Charter Renewal
Document Number: 2021-00947
Type: Notice
Date: 2021-01-19
Agency: Department of Health and Human Services, National Institutes of Health
National Human Genome Research Institute; Notice of Closed Meeting
Document Number: 2021-00946
Type: Notice
Date: 2021-01-19
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Environmental Health Sciences; Notice of Meeting
Document Number: 2021-00945
Type: Notice
Date: 2021-01-19
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Request. 30-Day Public Comment Request
Document Number: 2021-00939
Type: Notice
Date: 2021-01-19
Agency: Department of Health and Human Services
In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.
Securing Updated and Necessary Statutory Evaluations Timely
Document Number: 2021-00597
Type: Rule
Date: 2021-01-19
Agency: Food and Drug Administration, Department of Health and Human Services, Public Health Service, Office of the Secretary, Administration for Children and Families, Centers for Medicare and Medicaid Services, Office of the Inspector General
The Regulatory Flexibility Act (RFA) requires agencies to publish plans to conduct periodic reviews of certain of their regulations. Multiple Executive Orders also require agencies to submit plans for periodic reviews of certain regulations. To further comply with the RFA and Executive Orders, and to ensure the Department's regulations have appropriate impacts, the U.S. Department of Health and Human Services (HHS or the Department) issues this final rule amending its regulations to set expiration dates for the Department's regulations (subject to certain exceptions), unless the Department periodically assesses the regulations to determine if they are subject to the RFA, and if they are, performs a review that satisfies the criteria in the RFA.
Medicare and Medicaid Programs; Contract Year 2022 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicaid Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly
Document Number: 2021-00538
Type: Rule
Date: 2021-01-19
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final rule will revise regulations for the Medicare Advantage (Part C) program, Medicare Prescription Drug Benefit (Part D) program, Medicaid program, Medicare Cost Plan program, and Programs of All-Inclusive Care for the Elderly (PACE) to implement certain sections of the Bipartisan Budget Act of 2018 and the Substance Use Disorder Prevention that Promotes Opioid Recovery and Treatment(SUPPORT) for Patients and Communities Act (hereinafter referred to as the SUPPORT Act), enhance the Part C and D programs and the PACE program, codify several existing CMS policies, make required statutory changes, implement other technical changes, and make routine updates. As stated in the final rule that appeared in the Federal Register on June 2, 2020, CMS is fulfilling its intention to address the remaining proposals from the February 2020 proposed rule here. Although the provisions adopted in this second final rule will be in effect during 2021, most provisions will apply to coverage beginning January 1, 2022. Notwithstanding the foregoing, for proposals from the February 2020 proposed rule that would codify statutory requirements that were already in effect prior to this rule's appearance in the Federal Register, CMS reminds organizations, plan sponsors, and other readers that the statutory provisions apply and will continue to be enforced. Similarly, for the proposals from the February 2020 proposed rule that would implement the statutory requirements in sections 2007 and 2008 of the SUPPORT Act, CMS intends to implement these statutory provisions consistent with their effective provisions.
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