Department of Health and Human Services May 15, 2020 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency.'' On February 4, 2020, the Secretary of Health and Human Services (HHS) determined that there is a public health emergency and that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of the novel coronavirus (2019-nCoV). Rapid detection of Coronavirus Disease-2019 (COVID-19) cases in the United States requires wide availability of SARS-CoV-2 testing. This guidance was revised on March 16, 2020, May 4, 2020, and May 11, 2020. The guidance describes four policies intended to help facilitate the development and use of SARS-CoV-2 tests during the public health emergency: Two policies for accelerating the development of certain laboratory tests for COVID-19one leading to an Emergency Use Authorization (EUA) submission to FDA and the other not leading to an EUA submission when the test is developed under the authorities of the State in which the laboratory resides and the State takes responsibility for COVID-19 testing by laboratories in its State; a policy for commercial manufacturers to more rapidly distribute their SARS-CoV-2 diagnostics to laboratories for specimen testing after validation while an EUA submission is being prepared for submission to FDA; and a policy regarding the use of serological testing. In addition, FDA has included a reference to the availability, on FDA's website, of templates for commercial manufacturers and laboratories intended to facilitate EUA submissions for molecular, antigen, and serology tests. The guidance document is immediately in effect, but it remains subject to comment in accordance with the Agency's good guidance practices.

In accordance with the Federal Advisory Committee Act, this notice announces that the Secretary's Advisory Committee on Infant Mortality (ACIM) has scheduled a public meeting. Information about ACIM and the agenda for this meeting can be found on the ACIM website at https://www.hrsa.gov/advisory-committees/infant-mortality/ind ex.html.

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 Infant Feeding Practices Study III to understand the current state of mothers' intentions, behaviors, feeding decisions, and practices from pregnancy through their child's first two years of life and how these change.

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 ``Emerging Infections Program (EIP) Tracking of SARS-CoV-2 Infections among Healthcare Personnel''. Through this project, EIP staff will collect data to: (1) Determine the extent of COVID-19 among HCP working in U.S. healthcare facilities; (2) describe characteristics of HCP exposed to or infected with SARS-CoV-2, including clinical activities and personal protective equipment use; and (3) compare exposures and other characteristics of HCP cases and exposed HCP that do not become cases to identify risk factors or protective factors for COVID-19.

The Food and Drug Administration (FDA) 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 (PRA).