Department of Health and Human Services March 27, 2020 – Federal Register Recent Federal Regulation Documents

The Secretary of Health and Human Services (HHS) is issuing this notice pursuant to section 564 of the Federal Food, Drug, and Cosmetic (FD&C) Act. On February 4, 2020, the Secretary determined pursuant to his authority under section 564 of the FD&C Act that there is a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad and that involves a novel (new) coronavirus (nCoV) first detected in Wuhan City, Hubei Province, China in 2019 (2019-nCoV). The virus is now named SARS-CoV-2, which causes the illness COVID-19. On the basis of this determination, he also declared that circumstances exist justifying the authorization of emergency use of medical devices, including alternative products used as medical devices, pursuant to section 564 of the FD&C Act, subject to the terms of any authorization issued under that section.

The National Institute for Occupational Safety and Health (NIOSH), of the Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), is adding coronavirus disease 2019 (COVID-19), the disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), to the List of Potentially Life-Threatening Infectious Diseases to Which Emergency Response Employees May be Exposed. The list and companion guidelines are published by NIOSH pursuant to the Ryan White HIV/AIDS Treatment Extension Act of 2009. NIOSH encourages medical facilities to review the agency's guidelines describing the manner in which medical facilities should make determinations on whether an emergency response employee was exposed to COVID-19, the disease caused by SARS-CoV-2.

In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Lead Exposure and Prevention Advisory Committee (LEPAC). This meeting is open to the public by web conference; however, advance registration is needed by April 15, 2020, to receive the information to join the meeting. The registration link is https://rossstrategic.zoom.us/webinar/register/ WN_I76JZ04RT5SVinnqu_tSYw. The public comment period is scheduled on April 29, 2020, from 1:45 p.m. until 2:00 p.m., EDT. Individuals wishing to make a comment during the public comment period, please email your name, organization, and phone number by April 15, 2020, to LEPAC@cdc.gov.