Department of Health and Human Services September 2, 2020 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is establishing a public docket to collect comments related to the post-marketing pediatric-focused safety reviews of products posted between September 23, 2019, and September 1, 2020, on FDA's website but not presented at the September 15, 2020, Pediatric Advisory Committee (PAC) meeting. These reviews are intended to be available for review and comment by members of the PAC, interested parties (such as academic researchers, regulated industries, consortia, and patient groups), and the general public.

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register on May 14, 2020. The document announced the withdrawal of approval (as of June 15, 2020) of 16 new drug applications (NDAs) from multiple applicants. The document indicated that FDA was withdrawing approval of NDA 050641, Monodox (doxycycline monohydrate) Capsules, Equivalent to (EQ) 50 milligrams (mg) base, EQ 75 mg base, and EQ 100 mg base, after receiving a withdrawal request from Aqua Pharmaceuticals, LLC, 707 Eagleview Blvd., Suite 200, Exton, PA 19341. Before FDA withdrew the approval of NDA 050641, Aqua Pharmaceuticals, LLC, informed FDA that it did not want the approval of the NDA withdrawn. Because Aqua Pharmaceuticals, LLC, timely requested that approval of the NDA not be withdrawn, the approval of NDA 050641 is still in effect.

This interim final rule with comment period (IFC) revises regulations to strengthen CMS' ability to enforce compliance with Medicare and Medicaid long-term care (LTC) facility requirements for reporting information related to coronavirus disease 2019 (COVID-19), establishes a new requirement for LTC facilities for COVID-19 testing of facility residents and staff, establishes new requirements in the hospital and critical access hospital (CAH) Conditions of Participation (CoPs) for tracking the incidence and impact of COVID-19 to assist public health officials in detecting outbreaks and saving lives, and establishes requirements for all CLIA laboratories to report COVID-19 test results to the Secretary of Health and Human Services (Secretary) in such form and manner, and at such timing and frequency, as the Secretary may prescribe during the Public Health Emergency (PHE).