Department of Health and Human Services January 5, 2021 – Federal Register Recent Federal Regulation Documents

The Administration for Children and Families (ACF) proposes to extend the existing overarching generic clearance for Pre-testing of Evaluation Data Collection Activities (Office of Management and Budget (OMB) #0970-0355) with no changes.

Through this notice of funding opportunity (NOFO), the Centers for Medicare & Medicaid Services (CMS), Center for Clinical Standards and Quality, seeks an application for a single source, cooperative agreement, to develop a radiology electronic clinical quality measure(s) (eCQM) for the following CMS hospital programs: Hospital Inpatient Quality Reporting Program (IQR); Hospital Outpatient Quality Reporting Program (OQR); and Promoting Interoperability Program for Eligible Hospitals and Critical Access Hospitalsformerly Meaningful Use (PI). CMS will provide support to the awardee in their planning, technical assistance, and reporting needs related to submission of a fully developed and tested radiology measures to the 2021 Measures Under Consideration (MUC) List in May 2021.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``IND Submissions for Individualized Antisense Oligonucleotide Drug Products: Administrative and Procedural Recommendations.'' FDA is publishing this draft guidance to help sponsor-investigators (hereafter referred to as sponsors) developing individualized antisense oligonucleotide (ASO) drug products for a severely debilitating or life-threatening genetic disease. Most often, individuals with such diseases will not have adequate alternative therapy available for treating their disease. This draft guidance is intended to help sponsors of such development programs, who may be relatively unfamiliar with FDA regulations, processes, and practices, with the administrative and procedural aspects of interacting with FDA, including seeking feedback from FDA on their development programs and making regulatory submissions related to these development programs.

This information collection consists of several instruments that allow the Unaccompanied Alien Children (UAC) Program to assess the ability of potential sponsors to provide for the physical and mental well-being of the UAC and whether the UAC will be safe in the custody of the potential sponsor. 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 proposed revisions to the Sponsor Verification Application (formerly the Family Reunification Application); and the Sponsor Care Agreement. Revisions to the Sponsor Care Agreement change the categorization from supplementary material to an information collection and associated burden has been included in this update.