Department of Health and Human Services January 6, 2021 – Federal Register Recent Federal Regulation Documents

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 monitor care provider facility compliance with federal laws and regulations, legal agreements, and ORR policies and procedures; and perform other administrative tasks.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled ``Human Gene Therapy for Neurodegenerative Diseases; Draft Guidance for Industry.'' Neurodegenerative diseases are a heterogeneous group of disorders characterized by progressive degeneration of the structure and function of the central nervous system or peripheral nervous system. The draft guidance document provides recommendations to sponsors developing a human gene therapy (GT) product for neurodegenerative diseases affecting adult and pediatric patients. The guidance focuses on considerations for product development, preclinical testing, and clinical trial design.

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 proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled ``Temporary Halt In Residential Evictions To Prevent The Further Spread Of Covid-19'' The information collection originally pertained to the September 4, 2020 CDC order of the same name that temporarily halts residential evictions of covered persons for nonpayment of rent during September 4, 2020, through December 31, 2020. The Consolidated Appropriations Act, 2021, statutorily extended CDC's order until January 31, 2021. The declaration in this information collection request will serve as an attestation by a tenant, lessee, or resident that they meet the criteria therein to prevent an eviction proceeding per the order issued by the CDC.

This notice announces the 2021 meetings of the Physician- Focused Payment Model Technical Advisory Committee (PTAC). These meetings include deliberation and voting on proposals for physician- focused payment models (PFPMs) submitted by individuals and stakeholder entities and may include discussions on topics related to current or previously submitted PFPMs. All meetings are open to the public.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Safer Technologies Program for Medical Devices.'' This final guidance describes a new, voluntary program for certain medical devices and device-led combination products that are reasonably expected to significantly improve the safety of currently available treatments or diagnostics that target an underlying disease or condition associated with morbidities and mortalities less serious than those eligible for the Breakthrough Devices Program. Devices and device-led combination products are eligible for this program if they are subject to review under a premarket approval application (PMA), De Novo classification request (``De Novo request''), or premarket notification (510(k)), taking into account the specific eligibility factors described in this guidance. Consistent with the Agency's statutory mission to protect and promote public health, FDA believes that this ``Safer Technologies Program'' or ``STeP'' will help patients have more timely access to these medical devices and device-led combination products by expediting their development, assessment, and review, while preserving the statutory standards for premarket approval, De Novo marketing authorization, and 510(k) clearance.